Diagnosis of Obstructive Sleep Apnea: A Clinical Practice ...

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Updated Search Strategy (1 October 2010 to 30 May 2013):

Diagnosis of Obstructive Sleep Apnea: A Clinical Practice Guideline from the American College of

Physicians

Summary of Findings:

1. AHRQ Question-1: How do different available tests compare in their ability to diagnose

OSA in adults with symptoms suggestive of disordered sleep?

a. Comparison of portable devices and polysomnography

i. New Reports: 39 reports describing 36 populations

ii. Major Changes/Updates to ACP’s Clinical Practice Guidelines: None

b. Comparison of questionnaires and polysomnography



c. Clinical prediction rules and polysomnography



2. AHRQ Question-2: How does phased testing (screening tests of battery of followed by full

test) compare to full testing alone?

i. New Reports: 1 report


3. AHRQ Question-3: What is the effect of preoperative screening for OSA on surgical

outcomes?



4. AHRQ Question-4: In adults being screened for OSA, what are the relationships between

AHI or oxygen desaturation index (ODI), and other patient characteristics with respect to

long-term clinical and functional outcomes?

i. New Reports: 3 reports


Downloaded From: http://annals.org/ by a Penn State University Hershey User on 02/04/2015

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METHODS

We used systematic methods to identify relevant studies, apply inclusion and exclusion criteria,

evaluate study quality and summarize the four AHRQ questions regarding the diagnosis of OSA:

1. AHRQ Question-1: How do different available tests compare in their ability to diagnose

OSA in adults with symptoms suggestive of disordered sleep?

a. Comparison of portable devices and polysomnography

b. Comparison of questionnaires and polysomnography

c. Clinical prediction rules and polysomnography

2. AHRQ Question-2: How does phased testing (screening tests of battery of followed by full

test) compare to full testing alone?

3. AHRQ Question-3: What is the effect of preoperative screening for OSA on surgical

outcomes?

4. AHRQ Question-4: In adults being screened for OSA, what are the relationships between

AHI or oxygen desaturation index (ODI), and other patient characteristics with respect to

long-term clinical and functional outcomes?

Literature search

An investigator (J.C.H.) performed a previously described computerized search strategy from the

AHRQ report (Figure 1.) to identify relevant studies published between 1 October 2010 and 30 May

2013 in the MEDLINE electronic databases (Ovid MEDLINE and MEDLINE(R) In-Process). Non-

English language articles were excluded.

Inclusion and exclusion criteria

Initial search strategy (Figures 1 and 2) yielded a total of 2,435 articles. Inclusion and exclusion

criteria for each AHRQ question were derived from the original AHRQ report (Figure 3). A careful

review of titles and abstracts eliminated 1,728 articles. A review of full reports by one investigator

(J.C.H.) excluded 622 studies.

Study quality

Methodological criteria for study quality were adapted from those proposed by Kent et al., to

identify high-quality studies of the diagnosis for OSA (Figure 4) and utilized for AHRQ Questions 1 and

2.The revised criteria cover seven assessment categories: technical quality of index test, technical quality


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of the reference test, application of the reference test, independence of interpretations, clinical description,

cohort assembly and sample size.

Data abstraction

One investigator (J.C.H) abstracted primary data regarding patient characteristics and test

diagnostics (e.g. sensitivity and/or specificity).

Data synthesis and sensitivity/specificity calculations

We constructed 2 x 2 contingency tables for each study to summarize the results of the index test

and the reference test(s). For each study, the true positive rate (TPR; sensitivity), the false-positive rate

(FPR; 1-specificity), the diagnostic odds ratio, positive predictive value, negative predictive value,

positive likelihood ratio, negative likelihood ratio, diagnostic accuracy ([TP+TN]/N) and the kappa-1

statistic were calculated. We calculated a weighted kappa-1 coefficient (a generalization of the

unweighted or Cohen’s kappa coefficient) to assess accuracy with regards to avoiding false negative

results. Calculation of the kappa-1 coefficient does not require the false positive rate (1-specificity), but

does require knowledge of the marginal probabilities. Weighted kappa coefficient values close to one

suggest good test accuracy, while values less than 0.40 suggest only fair to poor test accuracy.

Statistical models

All biostatistical models were programmed in Excel 8.0 for Windows (Microsoft Corporation,

Redmond, Washington, USA). A normal approximation to the binomial of the standard error was used in

calculating all other CI’s, as appropriate. When making comparisons between groups of studies we used

an unpaired t-test or the Mann-Whitney U test as appropriate. A two-tailed p-value <0.05 was considered

statistically significant.

RESULTS

We identified 2,435 potentially relevant articles, of which 85 reports met inclusion criteria

(Figure 2, Tables 1-7). These included 36 reports describing 33 patient populations reporting the

diagnostic accuracy of portable testing (AHRQ Key Question 1a; Table 1), 3 reports describing 3 patient

population reporting outcomes other than diagnostic accuracy for portable testing (AHRQ Key Question

1a; Table 2), 41 reports describing 40 patient populations reporting diagnostic accuracy of screening

questionnaires (AHRQ Key Question 1b; Table 3), 6 reports describing 6 patient populations reporting


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diagnostic accuracy for clinical prediction rules (AHRQ Key Question 1c; Table 4), 1 report reporting

how phased testing compares to full testing (AHRQ Key Question 2; Table 5), 2 reports describing 2

patient populations reporting the effect of preoperative OSA screening on surgical outcomes (AHRQ Key

Question 3; Table 6), and 3 reports describing 2 patient populations describing long-term clinical and

functional outcomes in adults screened for OSA (AHRQ Key Question 4; Table 7).

Study Quality

The overall quality of the included studies in assessing sleep outcomes was generally fair (Tables

1-5).

I. AHRQ Key Question 1a: Comparison of portable devices and polysomnography

Thirty-six reports describing 33 patient populations reporting the diagnostic accuracy of portable

testing (Table 1) were included: 4 describing Type II portable devices (Table 8); 5 describing Type III

portable devices (Table 10); 11 describing Type IV portable devices (other than oximetry alone; Table

12); 10 describing oximetry alone reporting an oxygen desaturation index (ODI; (Table 14); and 6

describing oximetry alone with measures other than ODI (Table 16). Additionally, 3 studies reported

outcomes other than diagnostic accuracy using portable monitors (Table 2): two of these studies assessed

OSA treatment adherence and/or functional outcomes between those diagnosed with portable vs in-lab

polysomnography; one study assessed agreement between in-lab and home testing with regards to

therapeutic decision making. Many included studies excluded subjects with clinically significant cardiac,

pulmonary and/or neurologic disorders.

A. Findings:

a. Type II monitors vs. PSG

i. Four studies reported diagnostic accuracy of Type II devices compared with PSG

(Tables 8 and 9). Studies were highly heterogeneous with respect to populations

assessed and OSA definitions (particularly hypopneas). Reported diagnostic

accuracy was generally high with AUC’s generally above 0.90 and two of four

reporting positive Likelihood ratios ≥10 in subjects with an AHI cut-points

≥15/hr and/or ≥30/hr. However, only one study reported a negative likelihood

ratio ≤0.1 in subjects with AHI cut-points ≥15/hr.


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b. Type III monitors vs. PSG

i. Five studies reported diagnostic accuracy of Type III devices compared with

PSG (Tables 10 and 11). Studies were highly heterogeneous with respect to

populations assessed and OSA definitions (particularly hypopneas). Diagnostic

accuracy was reported as high with AUC’s generally above 0.89. However, only

one of six studies reported positive Likelihood ratios ≥10 in subjects with an AHI

cut-point ≥15/hr. Three of six studies reported a negative likelihood ratio ≤0.1 for

subjects with AHI cut-points of ≥5/hr and/or ≥15/hr.

c. Type IV monitors (other than oximetry alone) vs. PSG

i. Thirteen studies reported diagnostic accuracy of Type IV devices compared with

PSG (Tables 12 and 13). Studies were highly heterogeneous with respect to

populations assessed and OSA definitions (particularly AHI and hypopneas).

Diagnostic accuracy was reported as high with AUC’s generally above 0.85. Five

studies reported positive Likelihood ratios ≥10 in subjects with an AHI cut-point

≥5/hr and/or ≥15/hr. Five studies reported a negative likelihood ratio ≤0.1 in

subjects with an AHI cut-point ≥5/hr and/or ≥15/h.

d. Oximetry alone (reporting ODI) vs. PSG

i. Ten studies reported diagnostic accuracy of Oximetry (evaluating oxygen

desaturation index [ODI]) compared with PSG (Tables 14 and 15). Studies were

highly heterogeneous with respect to populations assessed and OSA definitions

(particularly AHI, hypopneas and ODI definitions). Diagnostic accuracy was

reported as high with AUC’s generally above 0.9. Four studies reported positive

Likelihood ratios ≥10 in subjects with an AHI cut-points ≥5/hr, ≥15/hr and/or

≥30/hr. Five studies reported a negative likelihood ratio ≤0.1 in subjects with an

AHI cut-point ≥5/hr and/or ≥15/hr.

e. Oximetry alone (reporting outcome other than ODI) vs. PSG

i. Six studies reported diagnostic accuracy of Oximetry (using outcomes other than

ODI) compared with PSG (Tables 16 and 17). Studies were highly

heterogeneous with respect to populations assessed, OSA definitions (particularly


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AHI and hypopneas definitions) and oximetry outcome measures. Diagnostic

accuracy was reported as high with AUC’s generally above 0.9. Only one study

reported a positive Likelihood ratio ≥10 in subjects with an AHI cut-points ≥5/hr

and/or≥15/hr. Two studies reported a negative likelihood ratio ≤0.1 in subjects

with an AHI cut-point ≥5/hr and/or ≥10/h.

f. Comparison of portable testing with PSG reporting outcomes other than diagnostic

accuracy

i. Three studies reported outcomes other than diagnostic accuracy in the

comparison of portable vs PSG testing (Table 2).

ii. Two studies randomized consecutive patients with high clinical OSA suspicion to

either a home testing pathway (both used Type III devices) vs in-lab PSG.

Primary outcomes were CPAP compliance (3 or 6-months) and/or functional

outcomes. Both studies concluded that home testing was not inferior to PSG with

respect to functional outcomes and CPAP adherence.

iii. One study assessed degree of agreement in therapeutic decisions (per AASM

criteria) between home and in-lab testing by performing both tests in patients

with suspected OSA with sleep physicians providing CPAP recommendations

based on each study (in a blinded protocol). The authors concluded that home-

testing was adequate when the AHI was high.

B. Major Changes/Updates to ACP’s Clinical Practice Guidelines: None

II. AHRQ Key Question 2a: Comparison of questionnaires and polysomnography

Forty-one reports describing 40 patient populations reporting the diagnostic accuracy of sleep

questionnaires (Table 18-29) were included: 15 describing the Berlin Questionnaire (BQ) (Table 18); 22

describing the Epworth Sleepiness Scale (ESS) (Table 20); 3 describing the Multivariate Apnea

Prediction Index (MAPI) (Table 22); 3 describing the Pittsburgh Sleep Quality Index (PSQI) (Table 24);

5 describing the STOP-BANG Questionnaire (Table 26); and 8 studies describing various other

questionnaires (Table 28).

A. Findings:


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a. Berlin Questionnaire vs Sleep Study Testing

i. Sixteen studies reported diagnostic accuracy of the Berlin Questionnaire

compared with a sleep study (Tables 18 and 19). Studies were highly

heterogeneous with respect to populations assessed, type of reference test used

and OSA definitions (particularly AHI and hypopneas). Reported diagnostic

accuracy was low with AUC’s ranging from 0.50 to 0.64. No study reported a

positive Likelihood ratio ≥10 or a negative likelihood ratio ≤0.1.

b. Epworth Sleepiness Scale vs Sleep Study Testing

i. Twenty-two studies reported diagnostic accuracy of the Epworth Sleepiness

Scale compared with a sleep study (Tables 20 and 21). Studies were highly




positive Likelihood ratio ≥10 or a negative likelihood ratio ≤0.1.

c. MAPI vs Sleep Study Testing

i. Three studies reported diagnostic accuracy of the Multivariate Apnea Prediction

Index compared with a sleep study (Tables 22 and 23). These three studies were

highly heterogeneous with respect to populations assessed, type of reference test

used and OSA definitions (particularly hypopneas). Only one study reported an

AUC of 0.77. No study reported a positive Likelihood ratio ≥10 or a negative

likelihood ratio ≤0.1.

d. PSQI vs Sleep Study Testing

i. Three studies reported diagnostic accuracy of the Pittsburgh Sleep Quality Index

compared with a sleep study (24 and25). These three studies were highly


and OSA definitions (particularly hypopneas). No study reported an AUC. No

study reported a positive Likelihood ratio ≥10 or a negative likelihood ratio ≤0.1.

e. STOP-BANG vs Sleep Study Testing


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i. Five studies reported diagnostic accuracy of the STOP-BANG compared with a

sleep study (Tables 26 and 27). Studies were highly heterogeneous with respect

to populations assessed, type of reference test used and OSA definitions

(particularly AHI and hypopneas). Reported diagnostic accuracy (using a BMI

cut-point >35 for the STOP-BANG) was low with AUC’s ranging from 0.49 to

0.77. No study reported a positive Likelihood ratio ≥10. Only one study reported

a negative likelihood ratio ≤0.1 for an AHI cut-point ≥30/hr and a STOP-BANG

≥2.

f. Other Questionnaires vs Sleep Study Testing

i. Eight studies reported diagnostic accuracy of various other questionnaires

compared with a sleep study (Tables 28 and 29). These eight studies were highly




positive Likelihood ratio ≥10. One study reported negative likelihood ratio ≤0.1

for the Friedman classification in patients with an AHI ≥15/hr and/or ≥30/hr.


III. AHRQ Key Question 3a: Comparison of clinical prediction rules and polysomnography

Six reports describing 6 patient populations reporting the diagnostic accuracy of clinical prediction

rules (Table A-1C) were included. For each prediction rule, only one study was identified.

A. Findings:

a. Clinical Prediction Rules vs Sleep Study Testing

i. Six studies reported diagnostic accuracy of various other questionnaires

compared with a sleep study (Tables 30 & 31). These six studies were highly


and OSA definitions (particularly AHI and hypopneas). Reported AUC’s ranged

from 0.64 to 0.77. No study reported a positive Likelihood ratio ≥10 and no study

reported negative likelihood ratio ≤0.1.


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IV. AHRQ Key Question 2: How does phased testing compare to full test alone?

Only one study reporting outcomes/diagnostic accuracy of phased testing (Table 5) was included.

A. Findings:

a. Phased testing vs Sleep Study Testing

i. One study compared phased testing (MAPI questionnaire or various OSA

symptoms followed by portable type 3) with a PSG (Tables 32 & 33). The

reported AUC was 0.85 (for an AHI ≥30 & ESS >10). The reported positive

Likelihood ratio was ≥3.9 and negative likelihood ratio was 0.06.


V. AHRQ Key Question 3: What is the effect of preoperative OSA screening on surgical

outcomes?

Only two studies reporting outcomes regarding preoperative OSA screening (Table 6).

A. Findings:

a. Preoperative Screening

i. One study performed PSG in 819 patients being evaluated for surgery and

compared the PSG findings with whether the anesthesiologist and surgeon

evaluating the patients (and blinded to the sleep study) correctly identified

patients at risk for OSA (Table 6). Anesthesiologists and surgeons failed to

identify those with moderate-severe OSA 60% and 92% respectively. The STOP-

BANG questionnaire correctly classified 92.5% and 93.1% of those misclassified

by the anesthesiologist and surgeon, respectively.

ii. Another study performed a Type IV study during propofol infusions during

surgery for transurethral resection of the bladder or prostate. The authors report


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that presence or severity of OSA did not “significantly” affect any perioperative

outcomes evaluated including spinal anesthesia level, monitoring time, propofol

infusion rate, intra-operative blood pressure, heart-rate or oxygen saturation

score.


VI. AHRQ Key Question 4: Predictors of long-term clinical and functional outcomes

Only three studies reporting outcomes regarding long-term clinical and functional outcomes were

identified (Table 7).

A. Findings:

a. Predictors of long-term clinical and functional outcomes

i. One study in 2,505 elderly male participants in the MrOS longitudinal Sleep

Study reported that severe OSA was associated with increased risk of death

(multivariate OR 1.74, 95% CI 1.04-2.89)

ii. One study in 819 patients in the Sleep Health Study (mean age 62 years, 42%

male) reported that subjects with incident cardiovascular disease (over 5-years)

experienced larger increases in AHI between sleep studies.

iii. One study in 784 elderly male participants in the MrOS longitudinal Sleep study

excluding those with baseline hypertension found no statistically significant

difference in incident hypertension with respect to baseline AHI.



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APPENDIX FIGURE LEGENDS

Figure 1. MEDLINE search strategy derived from AHRQ report.

Figure 2. Literature search and selection. Studies could meet one or more exclusion criteria. For

simplicity, only one primary exclusion criterion per study is shown.

Figure 3. Inclusion and exclusion criteria derived from AHRQ report.

Figure 4. Methodological quality questionnaire.


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Figure 1. MEDLINE search strategy. Databases: OVID MEDLINE, MEDLINE(R) In-Process

1 exp Sleep Apnea Syndromes/ or exp Sleep Apnea, Obstructive/

2 exp Airway Resistance/

3 exp snoring/

4 Upper airway resistance syndrome.mp.

5 Respiratory disturbance.mp.

6 obstructive sleep apn?ea.mp.

7 or/1-6

8 randomized controlled trial.pt.

9 controlled clinical trial.pt.

10 randomized controlled trials/

11 Random Allocation/

12 Double-blind Method/

13 Single-Blind Method/

14 clinical trial.pt.

15 Clinical Trials.mp. or exp Clinical Trials/

16 (clinic$ adj25 trial$).tw.

17 ((singl$ or doubl$ or trebl$ or tripl$) adj (mask$ or

blind$)).tw.

18 Placebos/

19 placebo$.tw.

20 random$.tw.

21 trial$.tw.

22 (randomized control trial or clinical control trial).sd.

23 (latin adj square).tw.

24 Comparative Study.tw. or Comparative Study.pt.

25 exp Evaluation studies/

26 Follow-Up Studies/

27 Prospective Studies/

28 (control$ or prospectiv$ or volunteer$).tw.

29 Cross-Over Studies/

30 or/8-29

45 exp Polysomnography/

46 exp Oximetry/

47 exp Monitoring, Physiologic/

48 pulse transit time.mp.

49 exp Monitoring, Ambulatory/

50 peripheral Arterial Tonometry.mp.

51 exp Questionnaires/

52 exp Diagnostic Tests, Routine/

53 exp "Laboratory Techniques and Procedures"/

54 (Epworth or Stanford or Berlin or Pittsburgh or scale).af.

55 (friedman or surgical or staging).mp.

56 STOP-Bang.af.

57 Sleep Apnea, Obstructive/di

58 or/45-57

Sleep Apnea

Comparative Studies

Sleep Apnea Diagnostic Terms


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59 exp "sensitivity and specificity"/

60 exp Predictive Value of Tests/

61 exp ROC CURVE/

62 exp Mass Screening/

63 exp diagnosis/

64 exp REPRODUCIBILITY OF RESULTS/

65 exp false negative reactions/ or false positive reactions/

66 predictive value.tw.

67 (sensitivity or specificity).tw.

68 accuracy.tw.

69 screen$.tw.

70 diagno$.tw.

71 roc.tw.

72 reproducib$.tw.

73 (false positive or false negative).tw.

74 likelihood ratio.tw.

75 accuracy.tw.

76 di.fs.

77 or/59-76

93 7 and 30 and 58

94 limit 93 to english language

95 limit 94 to humans

96 94 and humans.sh.

97 95 or 96

98 remove duplicates from 97

100 7 and 58 and 77

101 limit 100 to english language

102 limit 101 to humans

103 101 and humans.sh.

104 102 or 103

105 104 not (98)

106 remove duplicates from 105

General Diagnostic Tests

Group 3: Comparative studies

specific to OSA diagnosis

Group 4: Other OSA diagnosis


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Figure 2. Literature search and selection.


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Figure 3. Inclusion and Exclusion criteria

GENERAL

Inclusion:

1. adults (>16 years).

2. only English-language, published, peer-reviewed articles.

Exclusion: 1. more than 20 percent of the participants had neuromuscular disease, Down syndrome, Prader-Willi

syndrome, major congenital skeletal abnormalities, narcolepsy, narcotic addiction, Alzheimer’s

disease, epilepsy, or who had experienced a disabling stroke.

2. abstracts, conference proceedings, or other unpublished ―grey‖ literature.

I. Diagnostic testing (AHRQ Key Questions 1 & 2).

Inclusion:

1. Adults (>16 years).with symptoms, findings, history, and comorbidities that indicated an

increased risk of sleep apnea.

2. Prospective cross-sectional or longitudinal studies of any follow-up duration.

3. At least 10 study participants had to be analyzed with each test of interest

4. We included all portable devices with any combination of two or more channels and those

that measured the following single channels: pulse transit time, peripheral arterial tone, and

pulse oximetry.

5. For the first analysis (portable versus PSG) we included only studies that performed an

overnight PSG.

6. For the second analysis (questionnaires, etc. versus standard testing), we included studies that

evaluated screening and other questionnaires, scales that included clinical criteria (e.g., signs,

symptoms, history, and comorbidities), and other clinical decision making tools. These tests

could be compared to either overnight PSG or portable testing.

7. For the second analysis (questionnaires, etc. versus standard testing), accepted studies either

validated their models in a separate subgroup of study participants or had their models

evaluated in subsequent studies.

8. Phased testing (Key Question 2). We included any study that directly compared phased

testing (a series of tests performed dependent on the results of initial tests) with full testing

(overnight PSG) alone.

9. OUTCOME OF INTEREST: We included all studies reporting concordance or agreement

among tests, predictive value (sensitivity, specificity) for diagnosis, change in clinical

management, and clinical outcomes.

Exclusion:

1. Studies conducted in only asymptomatic or healthy general-population participants, as well as

those in patients with known sleep apnea, were excluded.

2. Verification bias in which not everyone had PSG as the comparator.

3. We excluded studies on devices that used other single channel tests, specifically those that

measured only heart rate, heart rate variability, or actigraphy alone.

4. For the second analysis (questionnaires, etc. versus standard testing), We excluded studies

that assessed only single patient characteristics or risk factors.

5. For the second analysis (questionnaires, etc. versus standard testing), We also excluded tests

that were not validated in a group of participants separate from the sample used to develop the

test.

II. Preoperative screening (AHRQ Key Question 3).

Inclusion:

1. all preoperative adult (>16 years) patients, irrespective of the surgery to be performed, as long

as they were scheduled to receive general anesthesia.


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2. assessed any test or predictor of sleep apnea.

3. prospective cross-sectional or longitudinal studies of any follow-up duration.

4. At least 10 study participants had to be analyzed with each test of interest

5. OUTCOME OF INTEREST: We included studies reporting all intraoperative events, surgical

recovery events, surgical recovery time, postsurgical events, length of intensive care or

hospital stay, and intubation or extubation failures.

Exclusion:

1. We excluded studies in which all patients were known to have sleep apnea. There were no

other restrictions based on patient symptoms or existing diagnoses.

III. Predictors of long-term outcomes (AHRQ Key Question 4).

1. We included studies of adults, regardless of health status, who had a baseline sleep study

performed for any reason.

2. Assessed AHI (or similar sleep study measures) together with other potential predictors of

long-term outcomes.

3. longitudinal studies enrolling ≥500 participants with a follow-up ≥1 year

4. report a multivariable analysis

5. OUTCOME OF INTEREST: We included analyses of long-term clinical outcomes of interest,

including all-cause mortality, cardiovascular-death, non-fatal cardiovascular disease, incident

hypertension, quality of life measures, incident stroke, and incident type 2 diabetes mellitus.


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Figure 4. Methodological quality questionnaire.

A. Index Test Quality (3 points)

a. Was diagnostic technique described in sufficient detail to reproduce the procedure?

b. Was the AHI or RDI defined?

c. Were hypopneas defined?

B. Reference Test Quality (1 point)

a. Was confirmatory diagnostic procedure clearly described?

C. Application of Reference Test (2 points)

a. Were both positive and negative results compared to a gold standard?

b. Was the reference test applied consistently within those with and without OSA?

D. Independence of Test Interpretation (1 point)

a. Was there blinding of polysomnography (Reference Test) diagnosis?

E. Clinical Description (3 points)

a. Did the study include complete demographic information as per the following:

i. Were age, gender and BMI of subjects noted?

ii. Was the severity of sleep apnea (either overall or per individual subject)

noted?

b. Were inclusion and exclusion criteria clearly specified and drop-outs noted?

F. Cohort Assembly (4 points)

a. Were subjects enrolled prospectively?

b. Were subjects enrolled consecutively?

c. Did more than 90% of enrolled sample complete the study?

d. Multi-center trial?

G. Sample Size (2 points)

a. Were at least 35 participants with OSA analyzed?

b. Were at least 35 participants without OSA analyzed?

Total Possible Score: 16 points


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Table 1. Studies on AHRQ Key Question 1a – Comparison of Diagnostic Accuracy Between Portable Devices and Polysomnography: Study Characteristics

Author, Year,

Study, Population,

Reference

Study Design/

Population

Num Study

Type

OSA Definition/

Comments

Quality Criteria

Index Test

Quality

Reference Test

Quality

Application of

Reference

Test

Independence

of Test

Interpretation

Clinical

Description

Cohort

Assembly

Sample

Size

Typ

e II

T

yp

e II

I T

yp

e IV

O

xim

etry

- O

DI

Oth

er O

xim

etry

Mea

sure

s

Was

dia

gn

ost

ic t

echn

iqu

e

des

crib

ed i

n s

uff

icie

nt

det

ail

to

rep

rodu

ce t

he

pro

cedu

re?

Was

th

e A

HI

or

RD

I d

efin

ed?

Wer

e h

ypo

pn

eas

def

ined

?

Was

con

firm

ato

ry d

iagno

stic

Pro

cedu

re c

lear

ly d

escr

ibed

?

Wer

e b

oth

po

siti

ve

and

neg

ativ

e

Res

ult

s co

mp

ared

to

a

gold

sta

nd

ard

?

Was

th

e re

fere

nce

tes

t ap

pli

ed

con

sist

entl

y w

ithin

tho

se w

ith

and

wit

hou

t O

SA

?

Was

th

ere

bli

nd

ing

of

poly

som

no

gra

phy

dia

gn

osi

s?

Ag

e, G

ender

Rep

ort

ed

OS

A S

ever

ity

Rep

ort

ed

Incl

usi

on

/Excl

usi

on

Cri

teri

a

Su

bje

cts

enro

lled

pro

spec

tiv

ely?

Su

bje

cts

enro

lled

con

secu

tivel

y?

≥90

% e

nro

lled

com

ple

te

Mult

i-ce

nte

r T

rial

≥35

Par

tici

pan

ts w

ith

OS

A

≥35

Par

tici

pan

ts w

itho

ut

OS

A

Ov

erall

Qu

ali

ty S

core

(0

-16

)

1. Nigro, 2013;

Hospital Aleman,

Buenos Aires,

Argentina

Search Strategy

Group 4

Prospective study of consecutive adult (age ≥18

years) patients referred to a

sleep clinic for possible OSA (snoring with/without apneas

and/or somnolence).

Exclusion criteria: use of oxygen, CPAP or NIPPV

during PSG, inadequate

PSG, <2 hours of recording (July2010 – Jan2011).

Age: 48.2 ±14.5 years Male: 69%

BMI: 30 ±7.2 kg/m2

ESS: NR RDI: 15.1/hr (median, IQR

6.3-34.6)

No OSA (RDI <5): 22% (12/55)

OSA (RDI ≥5/hr): 78% (43/55)

55 ˚ ̊ • ̊ ˚

AHI: NR RDI: sum of apneas,

hypopneas and RERA’s per

hour of sleep Hypopneas: NR; “in

agreement with international

criteria” RERA: NR

OSA: RDI ≥5/hr

Validation: Type I Polysomnography

(Harmonie or MiniPC)

•Type IV Sleep Study -

ApneaLink Ox

•Analyzed automatic vs

manual scoring. Only

manual scoring outcome(2) reported for this report.

• • ˚ • • • • • • • • • • ˚ • ˚ 13

2. Alvarez, 2012;

University of

Valladolid, Valladolid, Spain

Search Strategy

Group 4

Sleep clinic patients with

high clinical suspicion for

OSA undergoing sleep study testing.

Age: 52.3 ±13.7 years Male: 78%

240 ˚ ̊ ˚ • •

AHI: sum of apneas and

hypopneas per hour of sleep

Hypopneas: ≥50% decrease in nasal flow with either a >3%

oxygen desaturation or an

EEG arousal OSA: AHI ≥10/hr

• • • • • • ˚ • ˚ • • • • ˚ • • 13


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BMI: 29.8 ±4.4 kg/m2

ESS: NR AHI: 25.7 ±26.1/hr

No OSA (AHI <10): 33%

(80/240) OSA (AHI ≥10/hr): 67%

(160/240)

Validation: Type I

Polysomnography (Alice 5, Respironics)

•Nonin Puresat pulse oximeter (≤3 sec averaging

signal; sampling rate 1 Hz)

3. Chung, 2012;

University Health Network, Toronto,

ON, Canada

(ref Singh 2013)

Search Strategy

Group 3

Consecutive preoperative

adults (age ≥18 years) scheduled for surgery.

Excluded patients expected

to have abnormal EEG findings (e.g. brain tumors,

epilepsy patients, patients

with deep brain stimulators)

Age: 60.3 ±12.7 years

Male: 54% BMI: 30.5 ±6.8 kg/m2

ESS: NR

AHI: 9.1/hr (median, IQR 3.8-21.4)

No OSA (AHI <5): 36%

(171/475) OSA (AHI ≥5/hr): 64%

(337/475)

25 ˚ ̊ ˚ • ̊


hypopneas per hour of sleep Hypopneas: 30 to 90%

decrease in nasal flow with a

>4% oxygen desaturation OSA: AHI ≥5/hr

Validation: Type II Sleep

Study (Embletta X100)

•PULSOX-300i (Konica

Minolta)

• • • • • • • • • • • • • ˚ • • 15

4. Danzie-Soares,

2012; University of

Sao Paulo Medical

School, Sao Paulo,

Brazil

Search Strategy

Group 3

Consecutive patients with severe CAD age ≥40 years

referred for CABG.

Excluded patients with prior

OSA diagnosis, history of

stroke, severe disability,

clinical instability, decompensated heart failure,

changes in medication within

prior one month or using supplemental oxygen.

Age: 58 ±7 years Male: 76%

BMI: 27.6 ±27.6 kg/m2

ESS: 7 (range 5-11) AHI: 22.9 ±20.0/hr

No OSA (AHI <5): 12.9%

(9/70) OSA (AHI ≥5): 87.1%

(61/70)

70 ˚ • ̊ ˚ ˚

AHI: sum of apneas and hypopneas per hour of sleep

Hypopneas: 50 to 90%


>3% oxygen desaturation

OSA: AHI ≥5/hr


•Type III Sleep Study (Stardust II, Respironics)

• • • • • • ˚ • • • • • • ˚ • ˚ 13

5. Ferre, 2012;

Hospital Universitari

Vall d’Hebron,

Consecutive patients referred to a sleep unit for suspected

OSA. Excluded significant

68 • ̊ ˚ ˚ ˚


Hypopneas: ≥50% decrease

• • • • • • • • • • • • • ˚ • ˚ 14


20

Barcelona, Spain

Search Strategy

Group 3

comorbidities (dialysis-

dependent renal failure, CHF, severe COPD,

previous stroke or

psychiatric disorder)

Age: 55.9 ±14.5 yrs

Male: 57% BMI: 28.5 ±4.8 kg/m2

ESS: 8.6 ±9.5

AHI: 21.7 ±19.0/hr No OSA (AHI <5): 19%

(13/68)

OSA (AHI ≥5/hr): 81% (55/68)

in nasal flow with either a

≥3% oxygen desaturation or an arousal

OSA: AHI ≥5/hr


•Type II Sleep Study (Somte polygraph)

6. Ling, 2012; West

Australian Sleep

Disorders Research Institute, Australia

Search Strategy

Group 3

Sleep disorder clinic patients

referred for diagnostic PSG

between Feb2001 and June2010. Excluded studies

where PAP therapy was

used. If >1 PSG performed, only initial diagnostic PSG

included. Excluded PSG

studies with insufficient oxygen data or in patients

with insufficient data to determine BMI.

Age: 51.2 ±14.0 years Male: 65%

BMI: 32.5 ±9.0 kg/m2

ESS: NR AHI: 31.3 ±29.3/hr

OSA (AHI ≥15): 64%

(7327/11448) No OSA (AHI <15): 36%

(4121/11448)

11,448 ˚ ̊ ˚ • ̊

AHI: “Respiratory events

were scored using Chicago

criteria” Hypopneas: ≥50% decrease


≥3% oxygen desaturation or an arousal

OSA: AHI ≥5/hr


•Integrated pulse oximeter

(Nonin Xpod 3011)

•Provided separate test

diagnostics at various BMI

cut-points

• • • • • • ˚ • • • • • • ˚ • • 14

7. Marcos, 2012;

University of Valladolid,

Valladolid, Spain

Search Strategy

Group 3

Symptomatic patients

(sleepiness, snoring, witnessed apneas) suspected

of sleep apnea. Initial

population randomly divided into training and test sets.

Age: 52.2 ±13.7 years Male: 78%

BMI: 29.8 ±4.5 kg/m2

ESS: NR AHI: 26.4 ±26.7/hr

OSA (AHI ≥5): 80%

144 ˚ ̊ ˚ ˚ •

AHI: “Per rules proposed by

Rechtschaffen and Kales” Hypopneas: NR

OSA: AHI ≥5/hr


•Nonin PureSat pulse oximeter

• ˚ ˚ • • • ˚ • • ˚ ˚ ˚ • ˚ • ˚ 8


21

(115/144)

No OSA (AHI <5): 20% (29/144)

8. Morales, 2012;

University of

Pennsylvania, Pennsylvania, PA,

USA

Search Strategy

Group 4

Elderly subjects (recruited

from Penn Partners in

Healthy Living, a consumer membership for older adults)

with and without sleepiness

(2001-2005). Recruited an equal number of study

participants for each decile

of the multivariable apnea prediction (MAP)

instrument. Exclusion

criteria: unable to speak

English, cognitive

impairment, alcoholism, use

of sedative hypnotics, medical conditions that

would alter breathing pattern

(e.g. stroke, CHF), prior OSA diagnosis or treatment,

had Cheyne-Stokes or

primary central sleep apnea.

Age: 71.3 ±5.9 years Male: 34%

BMI: 30.5 ±7.6 kg/m2

ESS: NR (30% ESS >10) AHI: NR

OSA (AHI ≥5 & ESS >10):

27% (22/92) No OSA: 73% (70/92)

92 ˚ ̊ • ̊ ˚



Hypopneas: ≥50% decrease in nasal flow with either a

≥3% oxygen or EEG

arousals OSA: AHI ≥30/hr and ESS

>10


(Sandman, Embla)

•Type IV sleep study

(Rescare AutoSet, Resmed)

• • • • • • • • • • • • • ˚ • ˚ 14

9. Morillo, 2012;

Universidad de

Cadiz, Cadiz, Spain

Search Strategy

Group 3

Patients referred to a sleep

clinic for suspected OSA.

Inclusion criteria: age >14 years, medically stable

status. Exclusion criteria:

severe lung disease, severe daytime hypoxemia, known

coronary artery disease,

chronic insomnia, restless legs syndrome or psychiatric

disorder requiring

tranquillizers. First 37 patients formed training set

and remaining 78 patients

made up test set.

Age: 58.3 ±12.5 years

78 ˚ ̊ ˚ • •



Hypopneas: ≥50% decrease in nasal flow with a ≥4%

oxygen

OSA: AHI ≥5/hr Validation: Type I

Polysomnography

•Jaeger 70750A19 oximeter

• • • • • • ˚ • ˚ • • • • ˚ • ˚ 12


22

Male: 74%

BMI: 32.1 ±6.3 kg/m2 ESS: NR

AHI: 28.9 ±28.3/hr

OSA (AHI ≥5): NR No OSA (AHI <5): NR

10. Nigro, 2012;

Hospital Aleman,

Buenos Airesm Argentina

Search Strategy

Group 4

Consecutive patients referred

to sleep clinic for possible

OSA undergoing sleep testing.

Age: 53.7 ±15.4 years Male: 77%

BMI: 27.5 kg/m2(median,

IQR 24.7-31.2)

ESS: NR

AHI: 21.3/hr (median, IQR

8.8-43.5) RDI: 24/hr (median, IQR

11.5-45.3)

OSA (RDI ≥5): 86% (102/119)

No OSA (RDI <5): 14%

(17/119)

119 ˚ ̊ ˚ • ̊

AHI: NR

RDI: sum of apneas,

hypopneas and RERA’s per hour of sleep

Hypopneas: NR; “in

agreement with international criteria”

RERA: NR

OSA: RDI ≥5/hr

Validation: Type I

Polysomnography

(Neurotrace or MiniPC)

•Oximetry (Nonin)

•Combination of ODI and

clinical criteria (ESS and

comorbidity) evaluated simultaneously

• • ˚ • • • • • • • • • • ˚ • ˚ 13

11. O’Brien, 2012;

University of Michigan, Ann

Arbor, MI, USA

Search Strategy

Group 4

Women in third trimester of

pregnancy (≥28 weeks gestation) recruited from an

obstetric clinic.

Age: 30.2 ±7.1 years

Male: 100%

BMI: 31.9 ±3.0 kg/m2 ESS: NR

AHI: 5.4 ±8.5/hr

OSA (AHI ≥5): 26% (8/31) No OSA (AHI <5): 74%

(23/31)

31 ˚ ̊ • ̊ ˚


hypopneas per hour of sleep RDI: Number of respiratory

events (apnea, hypopnea,

and RERA) per hour of

sleep


in nasal flow with either a ≥3% oxygen desaturation or

EEG arousal

OSA: AHI ≥5/hr Validation: Type II

Polysomnography

(Medpalm)

•WatchPat 200 (Itamar)

• • • • • • • • • • • • • ˚ ˚ ˚ 13

12. Oliveria, 2012;

Universidade Federal

de Sao Paulo, Sao

Paulo, Brazil

Search Strategy

Group 4

Consecutive patients age ≥40 years attending a pulmonary

clinic with diagnosis of

GOLD Class II or III COPD with symptoms suggestive of

OSA (loud snoring, reported

apneas, excessive sleepiness). Exclusion

criteria: COPD exacerbation

26 • ̊ ˚ ˚ ˚

AHI: NR Hypopneas: ≥50% decrease

in nasal flow OR a <50%

reduction in nasal flow associated with either ≥3%



Validation: Type I

• ˚ • • • • • • ˚ • • • • ˚ ˚ ˚ 11


23

within 3 months, change in

bronchodilator therapy, other sleep-related disorders, prior

diagnosis or treatment for

OSA, severe cardiovascular disorders or neuromuscular

diseases, using oxygen,

psychotropic drugs, alcohol or drugs of abuse.


BMI: 31.0 ±5.6 kg/m2

ESS: 10.5 ±4.1 AHI: 23.0 ±3.5/hr

OSA (AHI ≥5): NR (90% of

enrolled patients had an AHI ≥5/hr; 41 of these were

excluded from the final

analysis) No OSA (AHI <5): NR

Polysomnography (Embla

N7000)

•Type II Polysomnography

(Stardust II, Philips-Respironics)

•High rate of inadequate portable Type II study

recordings notes (26 out of

67)

13. Onder, 2012;

Istanbul Training and

Research Hospital, Istanbul, Turkey

Search Strategy

Group 4

Sleep clinic patients

complaining of snoring and

apneas undergoing sleep study evaluations. Exclusion

criteria: peripheral vasculopathy, neuropathy,

DM, cardiac arrhythmias,

phalangeal deformity, bilateral cervical and

thoracic sympathectomy,

alpha adrenergic receptor blocker usage.

Age: 43.3 ±12.9 years Male: 64%

BMI: 30.5 ±4.5 kg/m2

ESS: NR AHI: 19.3 ±23.5/hr

OSA: NR

No OSA: NR

59 ˚ ̊ • ̊ ˚




oxygen desaturation OSA: NR

Validation: Type I

Polysomnography


• • • • • • ˚ • ˚ • • • • ˚ ˚ ˚ 11

14. Sommermeyer,

2012; University of

Gothenburg,

Gothenburg, Sweden

Search Strategy

Group 4

Sleep clinic patients with suspected sleep disordered

breathing recruited from four

sleep labs (Sweden and Germany).

Age: 54.0 ±14.0 years Male: 63%

BMI: 28.5 ±5.9 kg/m2

66 ˚ ̊ ˚ • ̊



in nasal flow with a ≥3% oxygen desaturation

OSA: AHI ≥5/hr

Validation: Type III Sleep Study (SOMNOcheck2)

• • • • • • ˚ • • • • • • • • ˚ 14


24

ESS: 10.0 ±5.0

AHI: 19.3 ±18.5/hr OSA (AHI ≥5): 65% (43/66)


(23/66)

•Oximetry – ODI

automatically scored by either ≥4% SO2 drop or

≥3% SpO2 drop with an

autonomic arousal (pulse rate ≥20% from baseline or

pulse wave amplitude

(PWA) attenuation ≥40% from baseline or PWA

attenuation ≥35% with pulse

rate increase ≥15% from baseline.

15. Ward, 2012;

Royal Brompton

Hospital and Imperial

College, London, UK

Search Strategy

Group 3

Adult (age 18-90 years)

patients with low or

preserved EF heart failure

recruited from outpatient

cardiology clinic. Exclusion

criteria: change in medications preceding 4

weeks, receiving therapy for

SDB. Recruited irrespective of clinical suspicion for

SDB.

Age: 69.8 (median, IQR

58.8-76.8) Male: 86%

BMI: 29.1 kg/m2 (median, IQR

25.4-32.7) ESS: NR

AHI: NR; for SDB 27.0/hr

(median) OSA (AHI ≥15): 45%

(77/171)

No OSA (AHI <15): 56% (96/171)

173 ˚ ̊ ˚ • ̊





≥3% oxygen or EEG arousal

OSA: AHI ≥15/hr Validation: Type II

Polysomnography

•Wrist worn pulse oximeter

• • • • • • ˚ • • • • • • ˚ • • 14

16. Bahammam,

2011; King Saudi

University, Riyadh, Saudi Arabia

Search Strategy

Group 3

Consecutive adult (age 18 to

65 years) patients referred to

a sleep clinic for suspected OSA (based on presence of

loud interrupted snoring,

daytime sleepiness or witnessed apneas. Excluded

patients with COPD,

elevated PaCO2, CHF, neuromuscular diseases and

those on home oxygen or

mechanical ventilation.

Age: 46.3 ±12.6 years

95 ˚ ̊ • ̊ ˚




≥3% oxygen desaturation or


Validation: Type I

Polysomnography

•Type IV Sleep Study

(ApneaLink, Resmed)

• • • • • • ˚ • • • • • • ˚ • ˚ 13


25

BMI: 34.1 ±7.9 kg/m2

Male:61% ESS:NR

AHI: 39.5 ±30.4/hr

OSA (AHI ≥5): 15% (14/95) No OSA (AHI <5): 85%

(81/95)

17. Batchelder,

2011; Clayton Sleep Institute of

Maplewood, MO;

Sleep Medicine Center of West

Seneca, NY, Sleep

Fit of Broomfield,

CO, USA

Search Strategy

Group 3


for suspected SDB. Excluded patients if they had

participated in an

investigational drug study within 7 days of enrollment.

Age: 52.7 ±13 years

Male: 61%

BMI:36.0 ±9.6 kg/m2

ESS: NR AHI: NR

OSA: NR

No OSA: NR

104 ˚ ̊ ˚ ˚ •

AHI: NR


oxygen desaturation

OSA: AHI ≥5/hr Validation: Type III Sleep

Study

•Pulse oximetry saturation

patterns recognition

algorithm (OxiMax SPD) designed to detect specific

signatures of SpO2 trend

associated with repetitive reductions in airflow (RRiA)

•Respiratory event and not

patient was the unit of analysis

• • • • • ˚ • • ˚ • • • • • ˚ ˚ 12

18. Bohning, 2011;

Karl-Hansen-Klinik, Bad Lippspringe,

Germany

Search Strategy

Group 4

Consecutive sleep clinic

patients (Jan2007-Sept2007). Exclusion criteria: dementia,

intolerance of pulse-

oximetry, severe

neurological conditions,

severe endocrinological

disorders.

Age: 55 ±13 years

Male: 82% BMI:31.6 ±5.9 kg/m2

ESS: NR

AHI: NR OSA: 87% (117/135)

No OSA: 13% (18/135)

135 ˚ ̊ ˚ • ̊

AHI: NR

Hypopneas: NR OSA: AHI ≥5/hr

Validation: Type I

Polysomnography

•Oximetry: ODI (undefined)

˚ ˚ ˚ ˚ • • ˚ • ˚ • • • • ˚ • ˚ 8

19. Bruyneel, 2011;

Saint-Pierre Hospital,

Brussels, Belgium

Search Strategy

Group 4

Consecutive adult (age ≥18 years) sleep clinic patients

with suspected OSA (all

complained of snoring and daytime sleepiness or had ≥2

other OSA symptoms).

Exclusion criteria: prior PSG, restrictive respiratory

diseases, distance >30 miles

66 • ̊ ˚ ˚ ˚



in nasal flow with either a ≥3% oxygen desaturation or

EEG arousal


Polysomnography (Medatec)

• • • • • • ˚ • • • • • • ˚ • ˚ 13


26

from sleep clinic.

Age: 48.9 ±12.1 years

Male: 59%

BMI: 30.5 ±7.3 kg/m2 ESS: NR

AHI: 26.4 ±30/hr

OSA (AHI ≥5): 81% (50/66) No OSA (AHI <5): 19%

(16/66)

•Type II device (Pamela V 3.631, Medatec)

20. Campbell, 2011;

Otago University Wellington,

Wellington, New

Zealand

Search Strategy

Group 4

Consecutive adult (Age >18

years) sleep clinic patients with suspected OSA

undergoing PSG. Exclusion

criteria: significant

psychiatric or cardiovascular

morbidity, limited mobility

or referred for an alternative sleep disorder.

Age: 49.1 ±13.8 years Male: 80%

BMI: 31.0 ±6.1 kg/m2

ESS: NR AHI: 34.5 ±29.0/hr

OSA (AHI ≥5): 80% (24/30) No OSA (AHI <5): 20%

(6/30)

30 • ̊ ˚ ˚ ˚


hypopneas per hour of sleep Hypopneas: A visible

decrease in nasal flow and

either a ≥3% oxygen

desaturation or an EEG

arousal


Polysomnogram (S=series,

Compumedics)

•Type II Sleep Study (Siesta

System, Compumedics)

• • • • • • ˚ • • • • • • ˚ ˚ ˚ 12

21. Chai-Coetzer,

2011; Repatriation

General Hospital and

Flinders Medical

Centre, South Australia

Search Strategy

Group 3

Adult patients (age 25-70

years) attending six primary

care clinics were recruited

(June2007-April2008).

Exclusion criteria: pregnancy, significant

cognitive impairment, poorly

controlled psychiatric disorder or prior OSA

treatment

Age: 55 years (range 45-62)

Male:53%

BMI: 31.7 kg/m2 (range 28.8-36.1)

ESS: 8 (range 4-10)

AHI: 26.9/hr (range 13.1-41.3)

OSA (AHI ≥30): 39%

(31/77) No OSA (AHI <30): 61%

(46/77)

77 ˚ ̊ • • ̊

AHI: NR

Hypopneas: Either ≥50%



desaturation or an EEG arousal

OSA: AHI ≥30/hr

Validation: Type I Polysomnogram

•Type IV Sleep Study

(ApneaLink, Resmed)

•ODI (3%)

• • • • • • ˚ • ˚ • • • • ˚ • ˚ 12


27

22. Cheliout-Heraut,

2011; Versailles-Saint-Quentin

University, Garches

Hospital, Garches, France

Search Strategy

Group 4

Patients with suspected OSA

based on daytime sleepiness and snoring. Exclusion

criteria: neurologic disorders,

parasomnias, RLS, PLM’s, severe respiratory disorder or

recent medication use

(dopamine agonists, benzodiazepines, opioids,

substance of abuse including

alcohol).


BMI: NR Male: 67%

ESS: NR

AHI: NR OSA (AHI ≥5/hr): 92%

(83/90)

No OSA (AHI <5/hr): 8% (7/90)

90 ˚ • ̊ ˚ ˚


hypopneas per hour of sleep Hypopneas: either ≥50%

decrease in nasal flow OR

≥30 decrease in nasal flow and either a ≥3% oxygen


arousal OSA: AHI ≥5/hr

Validation: Type 1

Polysomnography (Embla)

• Type III portable study (Somnolter device, Nomics)

• • • • • • ˚ ˚ • • • • • ˚ • ˚ 12

23. Chouchou, 2011;

Universite Claude

Bernard, Lyon, France

Search Strategy

Group 4

Subjects enrolled in the

PROOF study (a prospective,

observational, population cohort study assessing

Prognostic indicator of cardiovascular and

cerebrovascular events;

inclusion age ≥65 years; exclusion cardiovascular and

general morbidity) were

enrolled into the SYNAPSE (Systeme Nerveux

Autonome – Physiologie –

Sommeil -Epidemiologie) study

Age: 65.8 ±1.1years Male: 43%

BMI: 25.4 ±4.0 kg/m2

ESS: 5.5 ±3.4 AHI: NR

OSA (AHI ≥5/hr): 91%

(710/780)

No OSA (AHI <5/hr): 9%

(70/780)

780 ˚ ̊ • ̊ ˚



Hypopneas: ≥50% decrease in nasal flow and a ≥3%

oxygen desaturation OSA: AHI ≥15/hr

Validation: Type 3 Sleep

Study (HypnoPTT, Tyco Healthcare)

•Pulse Transit Time (PTT)

measured on the Type III

sleep study and an autonomic activation index

(AAI) was obtained using

the manufacturer’s analysis software.

• • • • • • • • ˚ • • • • ˚ • • 14

24. Driver, 2011;

Kingston General Hospital and Queen’s

University, Kingston,

Patients referred to a sleep

lab for diagnostic sleep testing. Exclusion criteria:

high-care needs, known

73 ˚ • ̊ ˚ ˚



decrease in nasal flow and a

• • • • • • • • • • • • • ˚ • ˚ 14


28

Ontario, Canada

Search Strategy

Group 4

hypercapnia or

hypoventilation

Age: 52.9 ±12.2 years

BMI: 32.2 ±6.8 kg/m2 Male: 41%

ESS: NR

AHI: 26.0 ±25.9/hr OSA (AHI ≥5/hr): 84%

(61/73)

No OSA (AHI <5/hr): 16% (12/73)

≥3% oxygen desaturation

AND an EEG arousal OSA: AHI ≥5/hr

Validation: Type I

Polysomnogram

•Type III portable study (MediByte)

25. Gjevre, 2011;

University of

Saskatchewan,

Saskatoon,

Saskatchewan,

Canada

Search Strategy

Group 4

Consecutive adult (age 21 to

70 years) women scheduled

for routine PSG to evaluate

clinically suspected OSA.

Exclusion criteria: strong

suspicion for another primary sleep disorder (e.g.

insomnia, narcolepsy, RLS,

parasomnia, nocturnal seizures), regular shift work,

lung disease CHF, unstable

angina, CVA or pregnancy in prior 6 months,

neuromuscular disease, renal failure.

Age: 52 ±11.0 years Male: 100%

BMI: 34.9 ±9.0 kg/m2

ESS: 9.6 ±4.4 AHI: 15.1 ±16.3/hr


(32/47) No OSA (AHI <5/hr): 32%

(15/47)

47 ˚ • ̊ ˚ ˚




in nasal flow and a ≥3%

oxygen desaturation


Polysomnogram

•Type III portable study

(Embletta 2601-1)

• • • • • • ˚ • • • • • • ˚ ˚ ˚ 12

26. Hedner, 2011;

Sahlgrenska University Hospital

Gothenburg, Sweden;

Brigham and Women’s Hospital

and Harvard Medical

School, Boston, MA , USA; Israel Institute

of Technology, Haifa,

Israel

Search Strategy

Multi-center study cohort

consisting of 139 sleep clinic patients referred for

suspected OSA, 17 normal

volunteers and 71 subjects randomly drawn from a

population study undergoing

ambulatory PSG studies in the evaluation between OSA

and hypertension.

Age: 49 ±14 years

BMI: 29 ±6 kg/m2

227 ˚ ̊ • ̊ ˚

RDI: Number of respiratory

events (apnea, hypopnea, and RERA) per hour of

sleep

Hypopneas: NR OSA: RDI ≥10/hr

Validation: Type I

Polysomnogram


• • ˚ • • • ˚ ˚ • • • ˚ • • • • 11


29

Group 3 Male: NR

ESS: NR RDI: 30 ±23/hr

OSA (RDI ≥10/hr):83%

(189/227) No OSA (RDI <10/hr): 17%

(38/227)

27. Marcos, 2011;

University of Valladolid,

Valladolid, Spain

Search Strategy

Group 3

Subjects suspected of OSA

due to daytime sleepiness, loud snoring or reported

apnea events.

Age: 52.4 ±13.8 years

Male: 77%

BMI: 29.8 ±4.2 kg/m2

ESS: NR

AHI: 24.8 ±25.2/hr

OSA (AHI ≥10/hr): 67% (64/96)


(32/96)

96 ˚ ̊ ˚ ˚ •

AHI: “According to the

rules proposed by Rechtschaffen and Kales”

Hypopneas: NR


Polysomnogram

•Nonin PurseSat pulse

oximeter

• ˚ ˚ • • • ˚ • • • • ˚ • ˚ • ˚ 10

28. Masa, 2011;

CIBER de

Enfermedades Respiratorias, Madrid

Spain

Search Strategy

Group 4

*Two published

papers in 2011 on same population*

Patients with suspected OSA

(snoring, observed apneas,

ESS>10, morning tiredness, no other suspected sleep

disorders) age 18 to 70 were

recruited from eight sleep centers in Spain (Dec2008-

Dec2009). Exclusion criteria:

unstable heart disease.

Age: 48.7 ±11.8 years

Male: 76% BMI: 31.0 ±6.6kg/m2

ESS: 11.6 ±5

AHI: 38.3 ±28.5/hr OSA: 90% (313/348)

No OSA: 10% (35/348)

348 ˚ • ̊ ˚ ˚



Hypopneas: ≥30% decrease in airflow and either ≥3%



Validation: Type I

Polysomnogram

•Type III sleep study

(BreastSC20 or Breat Medial AB)

• • • • • • ˚ • • • • • • • • • 15

29. Nigro, 2011;

Hospital Aleman,

Buenos Aires,

Argentina

Search Strategy

Group 4

*Two published

papers 2012 and 2011 on same population*

Prospective study of consecutive adult (age ≥18

years) patients referred to

sleep clinic for possible OSA (snoring with or without

apneas and/or somnolence).

Exclusion criteria: use of oxygen, CPAP, noninvasive

PAP during PSG;

uninterruptable PSG, recording time <2 hours

(Mar 2008-Nov 2008).

90 ˚ ̊ • ̊ ˚


RDI: sum of apneas,


Hypopneas: NR; “In

agreement with international criteria”

OSA: RDI ≥5/hr

Validation: Type I Polysomnogram (BiOPC or

NEUROTRACE)

• • ˚ • • • ˚ • • • • • • ˚ • ˚ 12


30

Age: 49.6 ±15.1 years Male: 77%

BMI: 29.3 kg/m2 (median,

IQR 25.2-32.5) ESS: NR

AHI: 11.8/hr (median; IQR

5.8-32.3) RDI: 13.9/hr (median, IQR

7-34.1)

OSA (RDI ≥5): 83% (75/90) No OSA (RDI <5): 27%

(15/90)

•Type IV sleep study (ApneaLink, Resmed)

•evaluated auto vs manual scoring

30. Yang, 2011;

Buddhist Tzu Chi

General Hospital,

Hualien, Taiwan

Search Strategy

Group 4

Cross-sectional study of

adult Chinese sleep clinic

patients (Feb2007-Dec2007).

Exclusion: diagnosis of

narcolepsy, central sleep apnea, non-Asians, age <18,

chronic pulmonary and heart

disease.

Age: 50.3 ±14.8 years

Male: 70% BMI: 26.8 ±5.7 kg/m2

ESS: 8.0 ±4.6 AHI: 18.5 ±19.7/hr

OSA (AHI ≥5): 63% (54/86)

No OSA (AHI <5): 37% (32/86)

86 ˚ ̊ • ̊ ˚




in airflow and either ≥4%

oxygen desaturation or an EEG arousal

OSA: AHI ≥5/hr

Validation: Type I Polysomnogram (Embla

A10)


(Oximetry and RIP-derived X-flow)

• • • • • • ˚ • • • • • • ˚ • ˚ 13

31. Alvarez, 2010;

University of

Valladolid, Valladolid, Spain

Two references

Search Strategy

Group 3

Subjects suspected of OSA

due to daytime sleepiness,

loud snoring, nocturnal choking and awakenings or

reported apnea events.

Age: 52.9 ±14.1 years

Male: 78%

BMI: 29.8 ±5.6 kg/m2 ESS: NR

AHI: 29.0 ±28.5/hr

OSA (AHI ≥10/hr): 68% (100/148)


(48/148)

148 ˚ ̊ • • •



Hypopneas: ≥50% decrease in airflow and either ≥3%



Validation: Type I

Polysomnogram

•Type IV sleep study (Single

channel airflow and Oximetry)

•Oximetry

• • • • • • ˚ • • • • ˚ • ˚ • • 13

32. Nigro, 2010;

Hospital Aleman,

Buenos Aires, Argentina

Consecutive adult (age ≥18

years) sleep clinic patients

with suspected OSA (July 2007-Nov2007). Exclusion

criteria: use of supplemental

66 ˚ ̊ • ̊ ˚



RDI: sum of apneas, hypopneas and RERA’s per

hour of sleep

• • • • • • ˚ • • • • • • ˚ • ˚ 13


31

Search Strategy

Group 4

oxygen or CPAP or other

modality of noninvasive positive airway pressure

during the PSG, inadequate

sleep studies.

Age: 51.6 ±14.1 years

Male: 71% BMI: 29.3 ±5.4 kg/m2

ESS: NR


RDI: 10.6/hr (median, IQR

5.4-34.1) OSA (RDI ≥5): 77% (51/66)


(15/66)

Hypopneas: Discernible

decrease in airflow and either ≥3% oxygen

RERA: an EEG arousal

associated with an alteration of the inspiratory contour in

the waves from the

thoracoabdominal bands OSA: RDI ≥5/hr

Validation: Type I

Polysomnogram (BIOPC or NEUROTRACE, Akonic)

•Type IV sleep study (ApneaLink, Resmed)

33. Yadollahi, 2010;

University of

Manitoba, Winnipeg,

MB, Canada

Search Strategy

Group 4

Sleep clinic patients undergoing in-lab PSG were

recruited.

Age: 51.4 ±11.9 years

Male: 71%

BMI: 31.9 ±6.4 kg/m2 ESS: NR

AHI: 23.6 ±30.3/hr OSA: NR

No OSA: NR

66 ˚ ̊ • ̊ ˚


Hypopneas: NR


Polysomnogram


(Oximetry and tracheal sound signals)

• • ˚ ˚ • • ˚ • ˚ • • • • ˚ ˚ ˚ 10

* Abbreviations: ˚ (No), • (Yes), afib (atrial fibrillation), AHI (apnea-hypopnea index), AASM (American Academy of Sleep Medicine), ASA (American Society of Anesthesiologists), BMI (body mass index), BQ (Berlin

questionnaire), CABG (coronary artery bypass graft), CAD (coronary artery disease), CHF (congestive heart failure), COPD (chronic obstructive pulmonary disease), CPAP (continuous positive airway pressure), CSA (central

sleep apnea), CV (cardiovascular), DM (diabetes mellitus), ECG (electrocardiograph), EEG (electroencephalographic arousal), EF (ejection fraction), ESS (Epworth sleepiness scale), FOSQ (functional outcomes sleep questionnaire), GFR (glomerular filtration rate), GOLD (global initiative for COPD), hr (hour), IIH (idiopathic intracranial hypertension), IQR (interquartile range), NA (not applicable), NIPPV (noninvasive positive airway

pressure), NR (not reported), Num (number), MAPI (multivariate apnea prediction index), MI (myocardial infarction), ODI (oxygen desaturation index), OSA (obstructive sleep apnea), PaCO2 (arterial partial pressure of

carbon dioxide), PAP (positive airway pressure), PLMS (periodic limb movements of sleep), PSG (polysomnography), RERA (respiratory effort related arousal), RDI (respiratory disturbance index), RLS (restless legs syndrome), SDB (sleep disordered breathing), VA (veterans administration)


32

Table 2. Studies on AHRQ Key Question 1a – Comparison of Outcomes Other Than Diagnostic Accuracy Between Portable Devices and Polysomnography: Study

Characteristics

Author, Year,

Study, Reference

Study Design Num Population OSA Definition/

Comments

Outcome(s)

1. Andreu, 2012;

Hospital of Sant

Joan d’Alacant,

Madrid, Spain

Search Strategy

Group 4

Sleep clinic patients referred for high level of

clinical OSA suspicion (ESS ≥12 and Sleep

Apnoea Clinical Score (SACS) ≥15. Exclusion

criteria: impaired lung function (COPD,

obesity-hypoventilation, restrictive disorders),

associated pathologies (psychiatric disorders,

neoplasms, RLS, other dyssomnias or

parasomnias), prior CPAP therapy. Patients

were randomized into three

diagnostic/treatment groups: 1) Portable sleep

study with home follow-up with a sleep unit

nurse (at 1, 3 and 6 months); 2) Portable sleep

study with hospital follow-up with a sleep

pulmonologist (at 1, 3 and 6 months); or 3) In-

lab polysomnography with hospital follow-up

with a sleep pulmonologist (at 1, 3 and 6

months). CPAP pressure was chosen via a

prediction formula and was not changed

during follow-up. Study was planned/powered

as a non-inferiority trial.

Primary Outcomes measured: CPAP

compliance at 6-months.

Secondary Outcomes measured: daytime

sleepiness (ESS), quality of life (FOSQ),

symptoms and cost per patient.

65 Age: 52 ±10 years

Male: 83%

BMI: 34 ±7 kg/m2

ESS: 15 ±3

AHI: 43 ±20/hr

No OSA (AHI <15/hr):

0% (0/65)

OSA (AHI ≥15/hr):

100% (65/65)

•Severe (AHI ≥30):

69% (45/65)

AHI: NR

Hypopneas: Not

defined

OSA: AHI ≥15/hr

•Type I

Polysomnogram

(Somnostar Alpha

41000,

SensorMedics)

•Type 3 sleep study

(Stardust polygraph,

Phillips Respironics)

•At 6-months, CPAP compliance (% used at least

4hr/night for 70% of days) was similar between each

treatment group (73% vs 68% vs 57%, p>0.05). At 6-

months, no statistically significant difference in ESS,

global FOSQ score, FOSQ activity score or FOSQ

symptoms score was noted between the three

treatment groups. The most expensive strategy was

group 2 (in-lab PSG with pulmonologist follow-up;

849 Euros) followed by group 3 (portable sleep study

with pulmonologist follow-up; 644 Euros) with the

least expensive being group 1 (portable sleep study

with home nurse follow-up; 590 Euros; ANOVA

p<0.001; direct comparison Group 1 and 3, p<0.05).

•Author’s conclusions: Patients with a high clinical

OSA probability can be diagnosed and treated in a

home setting with a high level of CPAP compliance

and lower costs than using either a hospital-based

approach or home RP/hospital follow-up.

2. Kuna, 2011;

Philadelphia VA

Medical Center,

Philadelphia, PA,

USA

Search Strategy

Consecutive patients referred to the

Philadelphia VA Medical Center and Veterans

Affairs Pittsburgh Healthcare System

(multicenter) with suspected OSA were

randomized to either ambulatory

management using a portable monitor (n=148)

or standard in-laboratory testing (n=148).

296 Age: 53.5 ±10.5 years

Male: 95%

BMI: 34.6 ±6.5 kg/m2

ESS: 12.4 ±5.2

AHI: 45.1 ±26.5/hr

No OSA (AHI <15/hr):

9% (26/296)

AHI: NR

Hypopneas: Not

defined

OSA: AHI ≥15/hr

•Type I

Polysomnogram

•No clinical or statistically significant difference in

CPAP adherence (3.5 ±2.5 hours/day vs 2.9 ±2.3

hours/day; p=0.08) between home group vs in-

laboratory group. A statistically significant

improvement in functional outcomes in both the home

group (mean FOSQ improvement 1.74 ±2.81;

p<0.001) and the in-laboratory groups (mean FOSQ


33

Group 4

Home testing pathway involved a type 3

portable diagnostic sleep study with

individuals with an AHI ≥15/hr started on

home autoCPAP for 4 to 5 days with CPAP

pressure selected based on pressure spent 90%

of time resulting in an AHI <10/hr. Patients

with an AHI <15/hr on home study underwent

in in-lab PSG for confirmation.

In-laboratory testing pathway involved in-

lab polysomnography with individuals with an

AHI ≥15/hr undergoing in-lab CPAP titration

per “recommended” guidelines and CPAP

prescribed at the lowest pressure associated

with an AHI <10/hr.

Primary Outcomes measured: functional

outcomes (FOSQ score) and CPAP treatment

adherence at 3-months.

OSA (AHI ≥15/hr): 91%

(270/296)

•Mild: NR

•Moderate: NR

•Severe: NR

•Type 3 sleep study

(Embletta, Embla)

improvement to 1.85 ±2.46; p<0.001). Similar

improvements in ESS (-2.6 ±5.2 vs -2.9 ±4.4),

psychomotor vigilance task, SF-12 and Center fir

Epidemiologic Studies Depression Scale (CES-D)

were observed between both testing pathways. Mean

percentage of days CPAP used at least 4 hours/day

was 52 ±34% in home tested group vs 49 ±35% in the

in-laboratory tested group (p= 0.42). The mean

residual AHI on CPAP downloads was 4.3 ±3.4/hr in

the home tested group and 4.7 ±3.5/hr in the in-

laboratory tested group (p=0.51)

•Lower bound of the one-sided 95% noninferiority CI

was -0.54 for the FOSQ and 0.03 for the CPAP

adherence.

•Author’s conclusions: Functional outcomes and

treatment adherence in patients evaluated according to

a home testing algorithm is not clinically inferior to

that in patients receiving standard in-laboratory

polysomnography.

3. Masa, 2011;

CIBER de

Enfermedades

Respiratorias,

Madrid Spain

Search Strategy

Group 4

Patients with suspected OSA (snoring,

observed apneas, ESS>10, morning tiredness,

no other suspected sleep disorders) age 18 to

70 were recruited from eight sleep centers in

Spain (Dec2008-Dec2009). Exclusion criteria:

unstable heart disease. All patients underwent

in-lab PSG and home-testing in random order

(within 3 days of each other) with tests scored

separately by blinded technicians. Authors

performed a masked post hoc analysis to

ascertain the agreement in therapeutic

decision-making between in-lab PSG and

home testing. Therapeutic decisions (CPAP,

no CPAP, impossible decision) were made by

a researcher in a random order (each patient

presented twice with either PSG or home

based testing information) blinded to

participant identification or other data. CPAP

recommendations based on AASM criteria:

348 Age: 48.7 ±11.8 years

Male: 76%

BMI: 31.0 ±6.6kg/m2

ESS: 11.6 ±5

AHI: 38.3 ±28.5/hr

No OSA (AHI <5/hr) 9%

(33/348)


(315/348)

•Mild (AHI 5-15):

37% (129/315)

•Moderate (AHI 15-

30): 12% (42/215)

•Severe (AHI≥30):

41% (144/315)

AHI: sum of apneas

and hypopneas per

hour of sleep

Hypopneas: ≥30%

decrease in airflow

and either ≥3%

oxygen desaturation

or an EEG arousal

OSA: AHI ≥5/hr

Validation: Type I

Polysomnogram

\•Type 3 sleep study

(BreastSC20 or Breat

Medial AB)

•Therapeutic decision using home based testing had a

sensitivity of 77%, a specificity of 77% and accuracy

of 76%. Patients with more severe OSA (AHI ≥30/hr)

had a sensitivity of 94% and specificity 44% and

accuracy of 91% with home based testing.

•Author’s conclusions: Home-based therapeutic

decision was adequate when AHI was high, but

deficient in the large population in patients with mild

to moderate AHI.


34

AHI (on either in-lab PSG or home sleep

study) ≥15/hr or AHI ≥5 with significant

symptoms or consequences.

Primary Outcomes measured: determine

agreement between home sleep testing and in-

hospital PSG for therapeutic decision making

in a large sample.

* Abbreviations: O

(No), • (Yes), afib (atrial fibrillation), AHI (apnea-hypopnea index), AASM (American Academy of Sleep Medicine), ASA (American Society of

Anesthesiologists), BMI (body mass index), BQ (Berlin questionnaire), CABG (coronary artery bypass graft), CAD (coronary artery disease), CHF (congestive heart failure),

COPD (chronic obstructive pulmonary disease), CPAP (continuous positive airway pressure), CSA (central sleep apnea), CV (cardiovascular), DM (diabetes mellitus), ECG

(electrocardiograph), EEG (electroencephalographic arousal), EF (ejection fraction), ESS (Epworth sleepiness scale), FOSQ (functional outcomes sleep questionnaire), GFR

(glomerular filtration rate), GOLD (global initiative for COPD), hr (hour), IIH (idiopathic intracranial hypertension), IQR (interquartile range), NA (not applicable), NIPPV

(noninvasive positive airway pressure), NR (not reported), Num (number), MAPI (multivariate apnea prediction index), MI (myocardial infarction), ODI (oxygen desaturation

index), OSA (obstructive sleep apnea), PaCO2 (arterial partial pressure of carbon dioxide), PAP (positive airway pressure), PLMS (periodic limb movements of sleep), PSG

(polysomnography), RERA (respiratory effort related arousal), RDI (respiratory disturbance index), RLS (restless legs syndrome), SDB (sleep disordered breathing), VA (veterans

administration)


35

Table 3. Studies on AHRQ Key Question 1b – Comparison of Diagnostic Accuracy Between Questionnaires and Polysomnography: Study Characteristics

Author, Year,

Study, Reference

Study Design/

Population

Num Study

Type

OSA Definition/

Comments

Quality Criteria

Index Test

Quality

Reference Test

Quality

Application of

Reference

Test

Independence

of Test

Interpretation

Clinical

Description

Cohort

Assembly

Sample

Size

Ber

lin Q

ues

tionn

aire

E

pw

ort

h S

leep

ines

s S

cale

M

ult

ivar

iate

Apn

ea P

red

icti

on

S

TO

P-B

AN

G

Oth

er

Was

dia

gn

ost

ic t

echn

iqu

e

des

crib

ed i

n s

uff

icie

nt

det

ail

to

rep

rodu

ce t

he

pro

cedu

re?

Was

th

e A

HI

or

RD

I d

efin

ed?

Wer

e h

ypo

pn

eas

def

ined

?

Was

con

firm

ato

ry d

iagno

stic

Pro

cedu

re c

lear

ly d

escr

ibed

?

Wer

e b

oth

po

siti

ve

and

neg

ativ

e

Res

ult

s co

mp

ared

to

a

gold

sta

nd

ard

?

Was

th

e re

fere

nce

tes

t ap

pli

ed

con

sist

entl

y w

ithin

tho

se w

ith

and

wit

hou

t O

SA

?

Was

th

ere

bli

nd

ing

of

poly

som

no

gra

phy

dia

gn

osi

s?

Ag

e, G

ender

, B

MI,

AH

I R

epo

rted

OS

A S

ever

ity

Rep

ort

ed

Incl

usi

on

/Excl

usi

on

Cri

teri

a

Su

bje

cts

enro

lled

pro

spec

tiv

ely?

Su

bje

cts

enro

lled

con

secu

tivel

y?

≥90

% e

nro

lled

com

ple

te

Mult

i-ce

nte

r T

rial

≥35

Par

tici

pan

ts w

ith

OS

A

≥35

Par

tici

pan

ts w

itho

ut

OS

A

Ov

erall

Qu

ali

ty S

core

(0

-16

)

1. Geiger-Brown,

2013; University of Maryland School of

Medicine, Maryland,

USA

Search Strategy

Group 3

Chronically partially sleep-

deprived shift-work registered nurses.


BMI: NR

ESS: NR AHI: 2.3 ±5.4/hr

OSA (AHI ≥5): 14% (3/21)

No OSA (AHI<5): 86% (17/21)

21 • ̊ ˚ ˚ ˚

RDI: sum of apneas,





>4% oxygen desaturation RERA’s: 30 to 90%


>3% oxygen desaturation OSA: AHI ≥5/hr

Validation: Type I

Polysomnography

• • • • • • ˚ ˚ • • • ˚ • ˚ ˚ ˚ 10

2. Sharkey, 2013;

Rhode Island

Hospital and Alpert Medical School of

Brown University,

Providence, RI, USA

Search Strategy

Group 4

Patients evaluated for bariatric

surgery (Jan 2003-Dec2005).

Retrospective chart review. Excluded patients who did not

complete PSG or ESS/FOSQ.


Male: 11%

BMI: 50.2 ±7.7 kg/m2 ESS: 6.3 ±4.8

AHI: 29.5 ±31.5/hr

OSA (AHI ≥15): 58% (157/269)

No OSA (AHI <15): 42%

(112/269)

269 ˚ • ̊ ˚ •



Hypopneas: ≥50% decrease in nasal flow with a >3%

oxygen desaturation


Polysomnography

•Other: Functional

Outcomes of Sleep

Questionnaire (FOSQ)

• • • • • • ˚ • • • ˚ • • ˚ • • 13


36

3. Vana, 2013;

Arizona State University, Phoenix,

AZ, USA

Search Strategy

Group 4

Consecutive new adult (age

≥18 years) patients referred to clinic for sleep evaluations.

Exclusion criteria: prior

diagnosis of OSA, health conditions that could affect

EEG tracings and sleep

staging (e.g. dementia, severe brain injuries, developmental

delay or stimulant use).

Age: 46.4 ±13.2 years

Male: 34%

BMI: 36.3 ±9.2 kg/m2 ESS: 8.0 (median, range 0-24)

AHI: 8.9/hr (median, range 0 -

99.9) OSA (AHI ≥5): 68% (32/47)


(15/47)

47 ˚ • ̊ • •


hypopneas per hour of sleep Hypopneas: ≥30% decrease

in nasal flow with a ≥4%


Validation: Type I

Polysomnography (diagnostic or split-night

protocols)

•Other: Combination of high

risk on STOP-BANG or

ESS >10

•Evaluated STOP-BANG

using various BMI cut-points: BMI >30, BMI >35

• • • • • • ˚ • • • • • • ˚ ˚ ˚ 12

4. Albuquerque,

2012; Mayo Clinic

Center, Rochester,

MN, USA

Search Strategy

Group 4

Prospective study of Afib patients referred for direct

current cardioversion

treatment.

Age: 69.1 ±11 years Male: 76%

BMI: 34.1 ±8.6 kg/m2

ESS: 8.9 ±4.4 AHI: 23.1 ±22.6/hr

SDB (AHI ≥5): 78%

(118/151) No SDB (AHI <5): 22%

(33/151)

(Pure OSA: 57%, Pure CSA: 10.6%, Mixed sleep apnea:

18.6%)

151 ˚ • ̊ ˚ ˚



decrease in nasal flow with a ≥4% oxygen

OSA: AHI ≥5/hr (obstructive events)

SDB: AHI ≥5/hr

(obstructive, central or mixed events)

• • • • • • ˚ • • • • • • ˚ • ˚ 13

5. Asha’ari, 2012;

Beserah Health Polyclinic, Kuantan,

Pahang, Malaysia

Search Strategy

Group 4

Adult (age 18 to 40) patients

recruited into a case-control study to assess the

association of OSA and HTN

in a younger population. Exclusion criteria:

pregnancy, unstable or

decompensated cardiorespiratory disease,

airway cancer, recent upper

respiratory tract surgery, prior OSA treatment,

inadequate/uninterpretable

240 ˚ • ̊ ˚ ˚

AHI: not reported

Hypopneas: “according to the AASM 2007 guidelines”

OSA: AHI ≥5/hr


•provides outcome data separately for hypertensive

and nonhypertensive

participants

• • • • • • ˚ • • • • • • ˚ • • 14


37

sleep study.


Male: 72%

BMI: 30.8 ±7.5 kg/m2 ESS: NR (32% ESS ≥10)

AHI: 25.9 ±4.5/hour

OSA (AHI ≥5): 68% (162/240)


(78/240)

6. Chung, 2012;

University of

Toronto, Toronto,

ON, Canada

Search Strategy

Group 4

Adult (age ≥18 years) patients scheduled for

elective surgery attending

preoperative clinic at two

hospitals (Toronto Western

Hospital and Mount Sinai

Hospital). Exclusion criteria: expected abnormal EEG

findings (e.g. brain tumour,

epilepsy, deep brain stimulator)

Age: 60 years (range 51-68) Male: 48%

BMI: 30 kg/m2 (range 26-34) ESS: NR

AHI:NR

OSA: (AHI ≥5): 68% (510/746)

No OSA (AHI<5): 32%

(236/746)

746 ˚ ̊ ˚ • ̊


Hypopneas: “scored

according to the American

Academy of Sleep Medicine

Task Force

recommendations” OSA:AHI ≥5/hr

Validation: Type 2 Portable

Sleep Study (Embletta X-100)

• • • • • • • ˚ • • • ˚ • ˚ • • 13

7. Danzie-Soares,

2012; University of

Sao Paulo Medical

School, Sao Paulo, Brazil

Search Strategy

Group 3

Consecutive patients with severe CAD age ≥40 years

referred for CABG.

Excluded patients with prior OSA diagnosis, history of

stroke, severe disability,

clinical instability, decompensated heart failure,

changes in medication within

prior one month or using supplemental oxygen.


BMI: 27.6 ±27.6 kg/m2

ESS: 7 (range 5-11) AHI: 22.9 ±20.0/hr

OSA (AHI ≥5): 87.1%

70 • • ̊ ˚ ˚



decrease in nasal flow with a >3% oxygen desaturation

OSA: AHI ≥5/hr


• • • • • • ˚ • • • • • • ˚ • ˚ 13


38

(61/70)

No OSA (AHI <5): 12.9% (9/70)

8. Facco, 2012;

Northwestern

University Prentice Women’s Hospital,

Chicago, IL, USA

Search Strategy

Group 3

Pregnant women at high risk

for sleep apnea

(hypertension, pregestational diabetes, BMI ≥30, prior

preeclampsia)


Male: 0%

BMI: 31.9 ±9.1 kg/m2 ESS: 7.5 ±4.3 (0-19)

AHI: 1.5/hr (median, IQR

0.6-6.0)

OSA (AHI ≥5): 28%

(28/100)

No OSA (AHI<5): 72% (72/100)

100 • • ̊ ˚ ˚

AHI: “analysis of the WP

100 signals allows for

determination of the AHI” Hypopneas: Not defined

OSA: AHI ≥5/hr

Validation: Type IV Sleep Study (Watch-PAT100,

Itamar Medical)

•Developed a four-variable

model to predict OSA –

however was not validated

in separate population

(excluded from ACP

systematic review)

• ˚ ˚ • • • ˚ • ˚ • • ˚ • ˚ ˚ • 9

9. Feng, 2012;

Tianjin Medical University General

Hospital, Tianjin,

China

Search Strategy

Group 4


to several sleep centers (n=20) for suspected OSA

(Jan2004 – Apr2006)

Age: 45.9 ±12.1 years

Male: 86%

BMI: 27.6 ±3.9 kg/m2 ESS: 9.4 ±5.0

AHI: 35.2 ±25.2/hr

OSA (AHI ≥5): 91%

(2084/2297)

No OSA (AHI<5): 9%

(213/2297)

˚ • ̊ ˚ ˚




>3% oxygen desaturation or signs of a physiologic

arousal


Polysomnography

• • • • • • ˚ • • • • • • • • • 15

10. Gjevre, 2012;

University of

Saskatchewan, Saskatoon, SK

Canada

Search Strategy

Group 3

12 Rheumatoid arthritis

patients with abnormal scores

on the ESS and/or Pittsburgh Sleep Quality Index were

age/gender matched to 13 RA

patients with normal ESS and PSQI. Exclusions: use of

anti-TNF-alpha agents, age

<18 years, pregnancy within prior 6-months.


BMI: 29.7 ±4.2 kg/m2

ESS: NR AHI: 14.7 ±14.8/hr

OSA (AHI ≥5): 68% (17/25)

25 • • ̊ ˚ ˚



Hypopneas: Not defined OSA: AHI ≥5/hr

Validation: Type I

Polysomnography

• • ˚ • • • • • ˚ • • • • ˚ ˚ ˚ 11


39

No OSA (AHI<5): 32%

(8/25)

11. Knutson, 2012;

National Institutes of

Health, Bethesda,

MD, USA

Search Strategy

Group 3

Obese (BMI 30-55) men and premenopausal women aged

18-50 years reporting less

than 6.5 hrs of sleep were analyzed from an ongoing,

randomized, prospective,

intervention trial (sleep extension study) from

11Sept2006 to 3Nov2009.

Recruited using advertisements. Self-reported

weight and thyroid hormonal

replacement therapy had to

be stable for preceding 6-

months.


Male: 30.2%

BMI: 38.2 ±5.9 kg/m2 ESS: 8.6 ±4.4

AHI: NR

OSA: (RDI ≥5) 66% (92/139)

No OSA (RDI<5): 34%

(47/139)

139 ˚ • ̊ ˚ •

RDI: sum of abnormal respiratory events per hour

of sleep

Hypopneas: 50 to 90% decrease in nasal flow with a

>3.5% oxygen desaturation

OR ≥1% desaturation with ≥1surrogate arousal

indicator

OSA: RDI ≥15/hr Validation: Type IV Sleep

Study (Apnea Risk

Evaluation System,

Advanced Brain Monitoring,

Inc)

•Other: Pittsburgh Sleep

Quality Index

• • • • • • ˚ • • • • • • ˚ • • 14

12. Koyama, 2012;


de Sao Paulo, Sao

Paulo, Brazil

Search Strategy

Group 3

Male railroad workers employed by a Brazilian

railroad company. Jan2008

to Nov2010.

Age: 35.6 ±9.6 years Male: 100%

BMI: 26.7 ±4.1 kg/m2

ESS: 7.9 ±3.6 AHI: NR

OSAS: 35% (261/745)

No OSAS: 65% (484/745)

745 • • ̊ ˚ ˚

AHI: Not defined Hypopneas: Not defined

OSAS: AHI ≥15/hr or (AHI

≥5/hr and ESS ≥10)

Validation: Type I

Polysomnography

• ˚ ˚ • • • ˚ • • • • • • ˚ ˚ ˚ 10

13. Laporta, 2012;

Western New York

Respiratory Research

Center, Buffalo, NY, USA

Search Strategy

Group 4

Consecutive veterans with ischemic heart disease

(documented MI, coronary

angiography, coronary artery bypass grafts) presenting to a

cardiology clinic at the VA

Western New York Healthcare System from

Oct2010-Sept2011.

Exclusion criteria: prior OSA diagnosis or treatment,

91 • ̊ ˚ ˚ ˚


Hypopneas: ≥50 decrease in

nasal flow with a >3% oxygen

OSA: AHI ≥5/hr


• • • • • • ˚ • • • • • • ˚ • ˚ 13


40

neurologic disease, systolic

CHF (EF<45%), receiving opiates.

Age: 67.7 ±11.8 years Male: 100%

BMI: 29.9 ±5.0 kg/m2

ESS: 9.3 ±4.8 AHI: 19.9 ±19.0/hr

OSA (AHI ≥5): 75% (69/91)

No OSA (AHI <5): 25% (22/91)

14. Martinez, 2012;


do Rio Grande do

Sul, Porto Alegre,

Brazil

Search Strategy

Group 3

Cross sectional analysis of

consecutive patients with

prior angina (age <65, BMI

≤40, no COPD or DM,

nonsmoker, prior CAD

intervention, recent angina, use of anxiolytic medication,

previous coronary

intervention). From Mar2007 to Feb2008

Age: 54 ±6.9 years Male: 46%

BMI: 23 ±11 kg/m2 ESS: NR

AHI: 17 ±14/hr

OSA (AHI ≥5): 79% (45/57) No OSA (AHI<5): 21%

(12/57)

57 • ̊ ˚ ˚ ˚





oxygen desaturation

OSA: AHI ≥5/hr Validation: Type III Home

Sleep Study

(SOMNOcheck)

• • • • • • ˚ • • • • • • ˚ • • 14

15. Morales, 2012;

University of Pennsylvania,

Pennsylvania, PA,

USA

Search Strategy

Group 4


from Penn Partners in Healthy Living, a consumer

membership for older adults)

with and without sleepiness (2001-2005). Recruited an

equal number of study

participants for each decile of the multivariable apnea

prediction (MAP)

instrument. Exclusion criteria: unable to speak

English, cognitive

impairment, alcoholism, use of sedative hypnotics,

medical conditions that

would alter breathing pattern (e.g. stroke, CHF), prior

OSA diagnosis or treatment,

92 ˚ ̊ • ̊ ˚




≥3% oxygen or EEG arousals

OSA: AHI ≥30/hr and ESS

>10 Validation: Type I

Polysomnography

(Sandman, Embla)

• • • • • • • • • • • • • ˚ • ˚ 14


41

had Cheyne-Stokes or

primary central sleep apnea.


Male: 34% BMI: 30.5 ±7.6 kg/m2

ESS: NR (30% ESS >10)

AHI: NR OSA (AHI ≥5 & ESS >10):

27% (22/92)

No OSA: 73% (70/92)

16. Morrell, 2012;

Dept of Population

Health Sciences,

University of

Wisconsin-Madison,

Madison, WI, USA

Search Strategy

Group 3

Wisconsin state employees (of four state agencies) aged

30-60 years evaluated in

1988.

Age: 50.4 years

Male: 74% BMI: 31.1 ±7.1 kg/m2

ESS: 8.7 ±4.1

AHI: NR OSA: (AHI ≥15): 84%

(606/3695)

No OSA (AHI<15): 16% (3089/3695)

3,695 ˚ • ̊ ˚ ˚


Hypopneas: discernible


≥4% oxygen

OSAS: AHI ≥15/hr or on

CPAP Validation: Type II Sleep

Study (Polygraph model 78)

• • • • • • ˚ • ˚ • • • • ˚ • • 13

17. Nicholl, 2012;

Dept of University of Calgary, Calgary,

Alberta, Canada

Search Strategy

Group 3

Adults (age ≥18 years) with

chronic kidney disease (GFR <60 mL/min/1.73 m2)

attending an outpatient

nephrology clinic. Exclusion

criteria: current supplemental

oxygen, tracheostomy,

inability to provide informed consent.


BMI: 31.2 ±8.3 kg/m2

ESS: 7.9 ±4.7 ODI(4%): 21.1 ±25.1/hr

OSA: (ODI ≥15): 39%

(46/119) No OSA (ODI<15): 61%

(73/119)

119 ˚ • ̊ ˚ •

ODI: sum of number of

episodes of desaturation ≥4% per hour of recording

OSA: ODI(4%) ≥15/hr

Validation: Type IV Sleep

Study (Remmers Sleep

Recorder Model 4.2)

•Also compared to a control

group with OSA but without

history of kidney disease (n=230).

•Other: Pittsburgh Sleep

Quality Index

• ˚ ˚ • • • • • ˚ • • • • ˚ • • 12

18. Ravesloot, 2012;

St. Lucas Andreas

Hospital, Amsterdam,

Netherlands

Search Strategy

Prospective study of consecutive adult (age 18-65

years) bariatric candidates.

Age: 43.0 ±10.0 years

Male: 28%

279 ˚ • ̊ ˚ ˚



in nasal flow with a ≥4% oxygen desaturation

OSA: AHI ≥5/hr

˚ • • • • ˚ ˚ • • • • • • ˚ • • 12


42

Group 4 BMI: 46.1 ±5.8 kg/m2

ESS: 8.0 ±5.0 AHI: NR

OSA: (AHI ≥5): 30%

(84/279) No OSA (AHI<5): 70%

(195/279)

Validation: Type I

Polysomnography

19. Senchak, 2012; San Antonio Military Medical Center, Fort

Sam Houston, TX,

USA

Search Strategy

Group 4

Multi-institutional,

prospective clinical trial in adult (age ≥18 years) patients

(active duty army)

undergoing tonsillectomy for chronic, recurrent tonsillitis.

Exclusion criteria: prior OSA

diagnosis.


Male: 48% BMI: 27.7 ±5.8 kg/m2

ESS: NR

AHI: 4.7 ±9.6/hr OSA: (AHI ≥5): 80% (52/77)

No OSA (AHI<5): 20%

(15/77)

77 ˚ ̊ ˚ ˚ •

AHI: NR


Validation: Type IV Sleep

Study (ApneaLink Plus, Resmed)

•Other: Two questionnaires

used to assess pretest

probability of OSA – High

pretest probability for OSA defined as an ESS ≥8 and a

positive Berlin snore score

(Berlin category 1 score ≥2)

• ˚ ˚ • • • ˚ • ˚ • • • ˚ • ˚ • 10

20. Sharwood, 2012; The George Institute

for Global Health, Sydney, Australia

Search Strategy

Group 4

Random sample of long

distance commercial truck

drivers

Age: 46.4 years

Male: 99%

BMI: 30.6 kg/m2

ESS: 5.9

AHI: 19.5 ±15/hr MAPI: NR

OSA: (AHI ≥18): 59%

(193/325) No OSA (AHI<18): 41%

(132/325)

325 ˚ ̊ • ̊ ˚

AHI: NR

Hypopneas: NR

OSA: AHI ≥18/hr Validation: Type IV sleep

study (flow monitor,

DiagnoseIT)

Multivariable Apnea

Prediction Index (MAPI)

• ˚ ˚ • • • ˚ • ˚ • • • ˚ ˚ • • 10

21. Bertolazi, 2011; Universidade Federal

do Rio Grande do Sul

(UFRGS), Brazil

Search Strategy

Group 4

Consecutive sleep clinic patients undergoing sleep

study evaluations

Age: 46.6 ±11.0 years

Male: 42%

BMI: 38.3 ±6.8.8 kg/m2 ESS: NR

AHI: 16.3 ±23.0/hr

PSQI: 10.8 ±4.7 OSA: (AHI ≥5): 48% (40/83)

No OSA (AHI<5): 52%

83 ˚ ̊ ˚ ˚ •

AHI: NR Hypopneas: NR

OSA: “per standards

established by the American Academy of Sleep Medicine

(AASM)”

Validation: “Polysomnography”

•Other: Pittsburgh Sleep Quality Index (PSQI)

• ˚ ˚ ˚ • • ˚ • ˚ • • • • ˚ • • 10


43

(43/83)

22. Chai-Coetzer,

2011; Repatriation

General Hospital and

Flinders Medical Centre, South

Australia

Search Strategy

Group 3

Adult patients (age 25-70 years) attending six primary

care clinics were recruited

(June2007-April2008). Exclusion criteria:

pregnancy, significant

cognitive impairment, poorly controlled psychiatric

disorder or prior OSA

treatment


Male:44%

BMI: 29.3 kg/m2 (range

25.5-33.8)

ESS: 7 (range 5-10) AHI: 16.5/hr (range 9.6-

28.2)

OSA (AHI ≥30): 21% (16/78)

No OSA (AHI <30): 79%

(62/78)

78 ˚ ̊ ˚ ˚ •

AHI: NR Hypopneas: Either ≥50%

decrease in nasal flow or a

≥3% oxygen desaturation or an EEG arousal

OSA: AHI ≥30/hr

Validation: Type I Polysomnogram

•Other: Two-stage model - OSA 50 questionnaire

(≥5/10) and ODI (3%)

(≥16/hr)

• • • • • • ˚ • ˚ • • • • ˚ • ˚ 12

23. Enciso, 2011;

University of

Southern California,

Los Angeles, CA, USA

Search Strategy

Group 4

Patients of the USC School of Dentistry

Age: 54.9 ±12.1 years Male: 77%

BMI: 26.6 ±18.1 kg/m2

ESS: NR

RDI: 24.3 ±18.1/hr

OSA (RDI ≥15): 63% (53/84)

No OSA (RDI<15): 37%

(31/84)

84 • ̊ ˚ ˚ •

RDI: Not reported Hypopneas: Not reported

OSA: RDI ≥15/hr

Validation: Type IV Home Sleep Study

•Other: Apnea Risk

Evaluation System (ARES)

questionnaire

• ˚ ˚ • • • ˚ • • ˚ • • • ˚ • ˚ 10

24. Farney, 2011;

LDS Hospital, Salt

Lake City, UT, USA

Search Strategy

Group 3

Consecutive patients referred to a sleep clinic who

underwent PSG testing for any

reason (1/2006-12/2008). Exclusion criteria: on

supplemental oxygen, prior

diagnosis or treatment for OSA, incomplete

questionnaire or demographic

data, insufficient/inadequate sleep study data.

Age: 49.7 ±15.2 years Male: 57.2%

1,426 ˚ ̊ ˚ • ̊


Hypopneas: studies prior to

4/2007, scoring based on “earlier” ‘Chicago’ criteria;

after this date based on

AASM 2007 standards OSA: AHI ≥5/hr

Validation: Type I

Polysomnogram

• • • • • • ˚ • • • • • • ˚ • • 14


44

BMI: 33.8 ±8.1 kg/m2

ESS: NR AHI: 32.9 ±30.1/hr

OSA(AHI≥5): 89.5%

(1274/1424) No OSA (AHI<5): 10.5%

(150/1424)

25. Gasa, 2011;

Hospital Universitari de Bellvitge,

Barcelona, Spain

Search Strategy

Group 4

Prospective multicenter cross-

sectional study of consecutive adult (age 18-60 years)

bariatric candidates from

Jan2009toFeb2010. Exclusion criteria: prior OSA diagnosis

or treatment, unstable CV

conditions, acute or chronic

inflammatory diseases in prior

6 months, chronic

immunosuppressant therapy, severe CHF, COPD,

psychiatric disorder,

pregnancy or current Alcohol abuse.

Age: 43.0 ±10.0 years Male: 28%

BMI: 46.1 ±5.8 kg/m2 ESS: 8.0 ±5.0

AHI: NR

OSA (AHI≥15): 72% (115/159)

No OSA (AHI<15): 28%

(44/159)

159 ˚ • ̊ ˚ ˚

AHI: Not defined


Validation: Type I

Polysomnography

• • • • • • ˚ ˚ ˚ • • • • • • • 13

26. Hrubos-Strom,

2011; Akerhus

University Hospital,

Lorenskog, Norway

Search Strategy

Group 3

Cross-sectional study of subjects residing in three

counties in central Norway

(age 30 to 65) randomly selected from the National

Population Register.

Age: 48.3 ±11.2 years

Male: 54.8%

BMI: 27.9 ±4.8 kg/m2 ESS: 8.8 ±4.6

AHI: 6.4/hr (median, IQR 1.7-

18.3) OSA (AHI ≥5): 16% (83/518)


(435/518)

518 • ˚ ̊ ˚ ˚



in nasal flow with a >4% oxygen desaturation

OSA: AHI ≥5/hr


• • • • • • ˚ • • • • • • ˚ • • 14


45

27. Khoo, 2011;

National University of Singapore,

Singapore

Search Strategy

Group 4


to a sleep clinic (Dec 2005 –Dec 2007).

Age: 47.5 ±13.9 years Male:79%

BMI: 28.5 ±5.8

ESS: NR AHI: 40.8 ±29.3/hr

OSA (AHI ≥20): 66%

(77/117) No OSA (AHI <20): 34%

(40/117)

117 ˚ • ̊ ˚ ˚


hypopneas per hour of sleep Hypopneas: ≥20% reduction

in nasal flow with a >3%


Validation: Type 1

Polysomnography

• • • • • • ˚ • ˚ • • • • ˚ • • 13

28. Kopitovic, 2011;

Institute for

Pulmonary Diseases

of Vojvodina, Serbia

Search Strategy

Group 4

Sleep clinic patients with OSA

symptoms undergoing sleep

study evaluations (June2006 –

Sept2009)

Age: 53 (median, IQR 43-59)

Male: 78%

BMI: 28 kg/m2 (median, IQR 25-32)

ESS: 9 (median, IQR 6-12)


OSA (AHI ≥5): 62% (70/112)

No OSA (AHI<5): 38%

(42/112)

112 ˚ • ̊ ˚ ˚




in nasal flow

OSA: AHI ≥5/hr Validation: Type 1

Polysomnography

(SomnoStar, Viasys)

• • • • • • ˚ • • • • • • ˚ • • 14

29. Martinez, 2011;


do Rio Grande do Sul

(UFRGS), Porto Alegre, RS, Brazil

Search Strategy

Group 4

Cross-sectional, prospective

study of consecutive adult (age

≥18 years) patients undergoing

sleep study testing for suspected OSA

Age: 46 ±14 years Male: 63.5%

BMI: 27 ±5.3 kg/m2

ESS: 10 ±5.1 AHI: 24 ±22/hr

OSA (AHI ≥5): 84%

(780/929) No OSA (AHI<5): 16%

(149/929)

929 ˚ • ̊ ˚ ˚




in nasal flow with a ≥3% oxygen desaturation or a 3-s

arousal


Polysomnography

•performed ESS

immediately before and day

after PSG. Pre-PSG ESS used in this analysis.

• • • • • • ˚ • • • • • • ˚ • • 14

30. Sareli, 2011;

University of

Pennsylvania,

Philadelphia, PA, USA

Consecutive bariatric surgery candidates referred for a sleep

study (11/2005-1/2007) at the

Penn Sleep Clinic for various reasons (irrespective of clinical

symptoms or findings

342 ˚ • • ̊ ˚



decrease in nasal flow with either a ≥3% oxygen


• • • • • • ˚ • • ˚ • • • ˚ • • 13


46

Search Strategy

Group 3

suggestive of OSA).

Age: 43.8 ±10.9 years

Male: 18.4%

BMI: 49.5 ±10.0 kg/m2 ESS: 8.7 ±5

AHI: 24.9 ±30.3/hr

OSA (AHI ≥5): 77% (264/342) No OSA (AHI <5): 23%

(78/342)

arousal


Polysomnography

31. Sert Kuniyoshi,

2011; Mayo Clinic and Foundation,

Rochester, MN, USA

Search Strategy

Group 3

Cross-sectional study of recent

MI patients (1 to 3 months prior). Excluded patients with

prior OSA diagnosis receiving

CPAP treatment.

Age: 62 ±13 years

Male: 81% BMI: 30 ±5 kg/m2

ESS: 9.1 ±4.2

AHI: NR OSA (AHI ≥5): 74% (73/99)

No OSA (AHI<5): 26%

(26/99)

99 • • ̊ ˚ ˚





OSA: AHI ≥5/hr

Validation: Type I

Polysomnography

• • • • • • • • • • • • • ˚ • ˚ 14

32. Sforza, 2011;

Universite Jean

Monnet, Saint-Etienne, France

Search Strategy

Group 3 & Group 4

Prospective study of

participants aged ≥65 from the

PROOF study (French population). Exclusion criteria:

prior diagnosis or treatment for

OSA, MI, CHF, stroke,

neurologic or psychiatric

disorders.


Male: 40.9%

BMI: 25.3 ±5.1 kg/m2 ESS: 5.6 ±5.1

AHI: 21.6 ±16.0/hr

OSA: (AHI ≥15): 57% (369/643)


(274/643)

643 • ˚ ̊ ˚ ˚




oxygen desaturation

OSA: AHI ≥15/hr

Validation: Type III Sleep

Study

•Provided data/outcomes

separately by gender and

Mini-Mental-State Examination

• • • • • • • • • • • • • ˚ • • 15

33. Silva, 2011;

Arizona State

University, Tucson, AZ, USA

Search Strategy

Group 4

Prospective multicenter cohort

population study (Sleep Heart

Health Study) in subjects age >40 years.

Age:62.4 ±10.3 years Male: 52%

BMI: NR (35% had BMI ≥30

4,770 ˚ • ̊ ˚ •




oxygen desaturation

OSA: AHI ≥5/hr Validation: Type II Sleep

Study (Compumedics

• • • • • • ˚ • • • • • • • • • 15


47

kg/m2)


OSA (AHI ≥5): 13%

(603/4770) No OSA (AHI<5): 87%

(4167/4770)

portable PS-2 system)

•Other: Takegami 4-variable

screening tool, STOP

questionnaire

34. Subramanian,

2011; Baylor College of Medicine,

Houston, TX, USA

Search Strategy

Group 3

Consecutive adult (age ≥18

years) patients referred to a sleep clinic for suspected sleep

apnea. Exclusion criteria:

prior OSA diagnosis, failed to perform an adequate sleep

study, did not complete study

questionnaire. Data collected

prospectively but analyzed

retrospectively.

Age: 55 ±14years

Male: 59%


RDI: 38 ±8/hr

OSA: (RDI ≥5): 85% (432/509)

No OSA (RDI<5): 15% (77/509)

509 • • ̊ ˚ •

RDI: sum of apneas,


Hypopneas: required ≥4%

oxygen desaturation in addition to defined reduction

in airflow per 2007

American Academy of Sleep

Medicine Scoring

Guidelines

RERA’s: NR OSA: RDI ≥5/hr

Validation: Type I

Polysomnography

•Other: NAMES assessment

(Neck circumference, airway classification, comorbidities,

Epworth scale, snoring)

• • • • • • ˚ • • • • ˚ • ˚ • • 13

35. Thurtell, 2011;

Emory University

School of Medicine,

Atlanta, Georgia,

USA

Search Strategy

Group 3

Newly diagnosed idiopathic

intracranial hypertension (IIH).

Retrospectively included all

patients with newly diagnosed

IIH (by Dandy criteria) and

completing BQ, sleep study. Exclusion criteria: age <16,

pregnancy, prior IIH diagnosis,

another cause for increased intracranial pressure.

Age: 32 (median, range 16-54) Male: 20%

BMI: 39.8 kg/m2 (median, range

27-52) ESS: NR

AHI: NR

OSA (AHI ≥5): 60% (18/30) No OSA (AHI<5): 40%

(12/30)

30 • ˚ ̊ ˚ ˚



Hypopneas: “determined

using conventional criteria.”

Reference to 2007 AASM

scoring criteria. OSA: AHI ≥5/hr

Validation: Type I

Polysomnography

• ˚ ˚ • • • • • • • • • • ˚ ˚ ˚ 11

36. Vaz, 2011;

University of Porto

Medical School,

Consecutive sleep clinic patients with suspected OSA.

Back translated Berlin

95 • ˚ ̊ ˚ ˚



• • • • • • ˚ • • • • • • ˚ • ˚ 13


48

Porto, Portugal

Search Strategy

Group 4

Questionnaire into

Portuguese language by two bilingual translators (both

sleep specialists) working

independently and then back translated into English by

two other bilingual

translators and then compared with original

English language version

with necessary adjustments to obtain a single Portuguese

version.

Age: 51 ±13 years

Male: 67%

BMI: NR (55% had BMI >30 kg/m2)

ESS:10 ±6

AHI: 24 ±17/hr OSA (AHI ≥5): 83% (79/95)

No OSA (AHI<5): 17%

(16/95)


≥4% oxygen desaturation. OSA: AHI ≥5/hr

Validation: Type 3 Sleep

Study (alpha screen; Vyasis)

37. Ong, 2010;

Singapore General

Hospital, Singapore

Search Strategy

Group 4

Consecutive sleep clinic patients (95% evaluated for

suspected sleep apnea) undergoing PSG testing

(Nov 2008 – April 2009)

Age: 47 ±15.2 years

Male: 71%

BMI: 27.8 ±5.9 kg/m2 ESS: 9.4 ±5.2

AHI: 26.2 ±26.9/hr

OSA: 75% (239/317) No OSA (AHI<5): 25%

(78/317)

317 ˚ ˚ ̊ • ̊




OR ≥3% oxygen and an EEG arousal

OSA: AHI ≥5/hr

Validation: Type 1 Polysomnogram

•Evaluated STOP-BANG using various BMI cut-

points: BMI ≥26, BMI ≥30,

BMI ≥35

• • • • • • ˚ • • • • • • ˚ • • 14

38. Patt, 2010; Ohio State University,

Columbus, OH, USA

Search Strategy

Group 4

Patients with new lower extremity non-healing

wounds from April to Sept

2009. No prior screening for symptoms or risk factors for

sleep apnea.

Age: NR

Male: NR

BMI: NR ESS: NR

AHI: 15.6/hr

46 • ˚ ̊ ˚ ˚



in nasal flow with a ≥4% oxygen

OSA: AHI ≥15/hr

Validation: Type 3 Polysomnography

• • • • • • ˚ ˚ • • • ˚ • ˚ • ˚ 11


49

OSA (AHI ≥5): 83% (38/46)

No OSA (AHI<5): 17% (12/46)

39. Rodrigues, 2010;

Santa Casa de

Limeira, Brazil

Search Strategy

Group 3

Patients complaining of

snoring and clinical history

suggestive of OSA and symptoms of daytime

sleepiness, non-restful sleep

and snoring were evaluated by sleep study.

Age: 48.0 ±11.3 years Male: NR

BMI: 29.4 ±5.6 kg/m2

ESS: 11.3 ±5.1

AHI: NR

OSA (AHI ≥5): 90%

(101/112) No OSA (AHI <5): 10%

(11/112)

101 ˚ ̊ ˚ ˚ •

AHI: NR

Hypopneas: NR


Polysomnography

•Other: Friedman’s

classification (modified

Mallampati scale, pharyngeal tonsil size and

BMI)

• ˚ ˚ ˚ • • ˚ ˚ • • • • • ˚ • ˚ 9

40. Tanaka, 2010;

Hyogo College of

Medicine, Hyogo,

Japan

Search Strategy

Group 3

Male passenger transportation workers (train and bus drivers,

rail conductors, mechanics)

age 20 to 50 years from April2005 to March2006

Age: 39.9 ±8.2 years Male: 100%

BMI: NR

ESS: NR

AHI: NR

OSA: (ODI(3%) ≥15): 15%

(108/715) No OSA (ODI(3%)<15): 85%

(607/715)

75 ˚ • ̊ ˚ ˚

ODI: sum of ≥3% desaturations per hour of

recording

OSA: ODI(3%) ≥15/hr Validation: Type IV sleep

study (Pulse Oximeter -

Pulsox-3, Konica Minolta)

• • • • • • ˚ ˚ • • • • • ˚ • • 13

* Abbreviations: O

(No), • (Yes), afib (atrial fibrillation), AHI (apnea-hypopnea index), AASM (American Academy of Sleep Medicine), ASA (American Society of Anesthesiologists), BMI (body mass index), BQ (Berlin

questionnaire), CABG (coronary artery bypass graft), CAD (coronary artery disease), CHF (congestive heart failure), COPD (chronic obstructive pulmonary disease), CPAP (continuous positive airway pressure), CSA (central sleep apnea), CV (cardiovascular), DM (diabetes mellitus), ECG (electrocardiograph), EEG (electroencephalographic arousal), EF (ejection fraction), ESS (Epworth sleepiness scale), FOSQ (functional outcomes sleep

questionnaire), GFR (glomerular filtration rate), GOLD (global initiative for COPD), hr (hour), IIH (idiopathic intracranial hypertension), IQR (interquartile range), NA (not applicable), NIPPV (noninvasive positive airway

pressure), NR (not reported), Num (number), MAPI (multivariate apnea prediction index), MI (myocardial infarction), ODI (oxygen desaturation index), OSA (obstructive sleep apnea), OSAS (obstructive sleep apnea syndrome), PaCO2 (arterial partial pressure of carbon dioxide), PAP (positive airway pressure), PLMS (periodic limb movements of sleep), PSG (polysomnography), RERA (respiratory effort related arousal), RDI (respiratory disturbance

index), RLS (restless legs syndrome), SDB (sleep disordered breathing), VA (veterans administration)


50

Table 4. Studies on AHRQ Key Question 1c – Comparison of Diagnostic Accuracy Between Clinical Prediction Rules and Polysomnography: Study Characteristics

Author, Year,

Study, Population,

Reference

Study Design Num Predictors OSA Definition/

Comments

Quality Criteria

Index Test

Quality

Reference Test

Quality

Application of

Reference

Test

Independence

of Test

Interpretation

Clinical

Description

Cohort

Assembly

Sample

Size

Was

dia

gn

ost

ic t

echn

iqu

e

des

crib

ed i

n s

uff

icie

nt

det

ail

to

rep

rodu

ce t

he

pro

cedu

re?

Was

th

e A

HI

or

RD

I d

efin

ed?

Wer

e h

ypo

pn

eas

def

ined

?

Was

con

firm

ato

ry d

iagno

stic

Pro

cedu

re c

lear

ly d

escr

ibed

?

Wer

e b

oth

po

siti

ve

and

neg

ativ

e

Res

ult

s co

mp

ared

to

a

gold

sta

nd

ard

?

Was

th

e re

fere

nce

tes

t ap

pli

ed

con

sist

entl

y w

ithin

tho

se w

ith

and

wit

hou

t O

SA

?

Was

th

ere

bli

nd

ing

of

poly

som

no

gra

phy

dia

gn

osi

s?

Ag

e, G

ender

, B

MI,

AH

I R

epo

rted

OS

A S

ever

ity

Rep

ort

ed

Incl

usi

on

/Excl

usi

on

Cri

teri

a

Su

bje

cts

enro

lled

pro

spec

tiv

ely?

Su

bje

cts

enro

lled

con

secu

tivel

y?

≥90

% e

nro

lled

com

ple

te

Mult

i-ce

nte

r T

rial

≥35

Par

tici

pan

ts w

ith

OS

A

≥35

Par

tici

pan

ts w

itho

ut

OS

A

Ov

erall

Qu

ali

ty S

core

(0

-16

)

1. Jauhar, 2012;

Glasgow Dental

Hospital, Glasgow, Scotland, UK

Search Strategy

Group 4

Consecutive adult (age >18

years) patients who

required a sleep study were recruited.

Age: 46.6 ±11.2 years Male: 75%

BMI: 32.5 ±8.7 kg/m2

ESS: 11.1 ±5.4

ODI: NR (for those with

OSA, median ODI 24, IQR

11,68) OSA (ODI ≥10/hr and ESS

≥10): 52% (37/71)

No OSA: 48% (34/71)

71 BMI, neck

circumference,

palatal height, maxillary and

mandibular

intermolar distance, overjet

ODI: NR

OSA: ODI ≥10/hr and ESS

≥10 Validation: Type IV Sleep

Study (Somnoscreen)

•Kushida Index developed

previously to predict clinically

suspected OSA

• ̊ ˚ • • • ˚ • • • • • • ˚ • ˚ 11

2. Morales, 2012;

University of

Pennsylvania, Pennsylvania, PA,

USA

Search Strategy

Group 4


from Penn Partners in

Healthy Living, a consumer membership for older

adults) with and without

sleepiness (2001-2005). Recruited an equal number

of study participants for

each decile of the

multivariable apnea

prediction (MAP)

instrument. Exclusion criteria: unable to speak

English, cognitive

impairment, alcoholism,

92 Apnea symptoms,

neck circumference,

age




≥3% oxygen or EEG

arousals OSA: AHI ≥30/hr and ESS

>10

Validation: Type I

Polysomnography

(Sandman, Embla)

•Optimal parameters set as

one that minimized total

prediction errors, computed as

• • • • • • • • • • • • • ˚ • ˚ 14


51

use of sedative hypnotics,

medical conditions that would alter breathing

pattern (e.g. stroke, CHF),

prior OSA diagnosis or treatment, had Cheyne-

Stokes or primary central

sleep apnea.


Male: 34% BMI: 30.5 ±7.6 kg/m2

ESS: NR (30% ESS >10)

AHI: NR OSA (AHI ≥5 & ESS >10):

27% (22/92)

No OSA: 73% (70/92)

sum of false-positives and

false-negative predictions.

3. Su, 2012; Cathay General Hospital,

Taipei City, Taiwan

Search Strategy

Group 3

Consecutive patients with suspected OSA recruited

from Oct2007 to July2008.

Age: 48.3 ±11.9 years

Male:77%

BMI: 24.8 ±3.1 kg/m2 ESS: 10.1 ±6.4

AHI: NR OSA (RDI ≥5): 72%

(21/29)

No OSA (RDI <5): 28% (8/29)

29 Age, weight, SBP, DBP, DI3, DI4

RDI: “Number of events per hour”

Hypopnea: NR

OSA: RDI ≥5/hr Validation: Type 1

polysomnogram

•Applied multiclass

Mahalanobis-Taguchi system (MMTS) based on

anthropometric information

and questionnaire data to predict OSA.

• • • • • • ˚ ˚ • • • • • ˚ ˚ ˚ 11

4. Khoo, 2011;

National University

of Singapore, Singapore

Search Strategy

Group 4

Consecutive patients

referred to a sleep clinic

(Dec 2005 –Dec 2007).

Age: 45.5 ±13.5 years

Male:81% BMI: 29.6 ±5.7 kg/m2

ESS: NR

AHI: 40.8 ±29.5/hr OSA (AHI ≥20): 65%

(34/52)

No OSA (AHI <20): 35% (18/52)

52 Flemons Index: 4-

variable model (neck

circumference, HTN, habitual snoring and

gasping or choking)

Koo Model: age,

male gender, neck

circumference, frequent awakenings

with unrefreshing

sleep



Hypopneas: ≥20% reduction in nasal flow with a >3%

oxygen desaturation


polysomnogram

•Flemons Index developed

previously to predict

clinically suspected OSA

•Koo Model developed and

validated in current study

• • • • • • ˚ • ˚ • • • • ˚ • • 13

5. Kolotkin, 2011;

LDS Hospital, Salt

Lake City, UT, USA

Search Strategy

Bariatric surgery candidates

(BMI >40 or ≥35 with 2 co-

morbidities). Exclusion criteria: prior weight loss

surgery, gastric/duodenal

310 BMI, age, HgA1C,

insulin level,

gender, neck circumference



Hypopneas: “A reduction” in nasal flow with a >4%

oxygen desaturation

• • • • • • ˚ • • • • • • ˚ • • 14


52

Group 3 ulcers or MI within prior 6

months, active cancer within prior 5 years, history

of alcohol/narcotics use,

use of supplemental oxygen or CPAP for OSA.

Age: 41.6 ±10.4 years Male:16%

BMI:46.8 ±7.5 kg/m2

ESS: NR AHI: NR

OSA (AHI ≥5): 81%

(252/310) No OSA (AHI <5): 19%

(58/310)

OSA: AHI ≥5/hr

Validation: Type III Sleep Study

•Dixon prediction model developed previously to

predict clinically suspected

OSA in bariatric surgery candidates.

6. Sun, 2011; Tapai

Medical University, Tapai, Taiwan

Search Strategy

Group 3

Patients from a teaching

hospital; suspected of sleep disordered breathing

referred for sleep study.

Age: 43.4 ±12.7 years

Male: 76%

BMI: NR (20% BMI >25 kg/m2)


OSA (AHI ≥5): 77%

(85/110) No OSA (AHI <5):23%

(25/110)

110 29 variables AHI: NR


Validation:

“Polysomnography test”

•Genetic algorithm was used

to build the five best models based on questions taken

from the Berlin Questionnaire, Rome

Questionnaire, ESS and

BASH’IM score

˚ ˚ ˚ ˚ • • ˚ ˚ • • ˚ ˚ • ˚ • ˚ 6

* Abbreviations: O

(No), • (Yes), afib (atrial fibrillation), AHI (apnea-hypopnea index), AASM (American Academy of Sleep Medicine), ASA (American Society of Anesthesiologists), BMI (body mass index), BQ (Berlin

questionnaire), CABG (coronary artery bypass graft), CAD (coronary artery disease), CHF (congestive heart failure), COPD (chronic obstructive pulmonary disease), CPAP (continuous positive airway pressure), CSA (central sleep apnea), CV (cardiovascular), DM (diabetes mellitus), ECG (electrocardiograph), EEG (electroencephalographic arousal), EF (ejection fraction), ESS (Epworth sleepiness scale), FOSQ (functional outcomes sleep questionnaire), GFR

(glomerular filtration rate), GOLD (global initiative for COPD), hr (hour), IIH (idiopathic intracranial hypertension), IQR (interquartile range), NA (not applicable), NIPPV (noninvasive positive airway pressure), NR (not reported),

Num (number), MAPI (multivariate apnea prediction index), MI (myocardial infarction), ODI (oxygen desaturation index), OSA (obstructive sleep apnea), PaCO2 (arterial partial pressure of carbon dioxide), PAP (positive airway pressure), PLMS (periodic limb movements of sleep), PSG (polysomnography), RERA (respiratory effort related arousal), RDI (respiratory disturbance index), RLS (restless legs syndrome), SDB (sleep disordered breathing), VA

(veterans administration)


53

Table 5. Studies on AHRQ Key Question 2 – How does phased testing compare to full test alone: Study Characteristics

Author, Year, Study,

Population, Reference

Study Design Num Phase Testing

Algorithm

OSA Definition/

Comments

Quality Criteria

Index Test

Quality

Reference Test

Quality

Application of

Reference

Test

Independence

of Test

Interpretation

Clinical

Description

Cohort

Assembly

Sample

Size

Was

dia

gn

ost

ic t

echn

iqu

e

des

crib

ed i

n s

uff

icie

nt

det

ail

to

rep

rodu

ce t

he

pro

cedu

re?

Was

th

e A

HI

or

RD

I d

efin

ed?

Wer

e h

ypo

pn

eas

def

ined

?

Was

con

firm

ato

ry d

iagno

stic

Pro

cedu

re c

lear

ly d

escr

ibed

?

Wer

e b

oth

po

siti

ve

and

neg

ativ

e

Res

ult

s co

mp

ared

to

a

gold

sta

nd

ard

?

Was

th

e re

fere

nce

tes

t ap

pli

ed

con

sist

entl

y w

ithin

tho

se w

ith

and

wit

hou

t O

SA

?

Was

th

ere

bli

nd

ing

of

poly

som

no

gra

phy

dia

gn

osi

s?

Ag

e, G

ender

, B

MI,

AH

I R

epo

rted

OS

A S

ever

ity

Rep

ort

ed

Incl

usi

on

/Excl

usi

on

Cri

teri

a

Su

bje

cts

enro

lled

pro

spec

tiv

ely?

Su

bje

cts

enro

lled

con

secu

tivel

y?

≥90

% e

nro

lled

com

ple

te

Mult

i-ce

nte

r T

rial

≥35

Par

tici

pan

ts w

ith

OS

A

≥35

Par

tici

pan

ts w

itho

ut

OS

A

Ov

erall

Qu

ali

ty S

core

(0

-16

)

1. Morales, 2012;

University of Pennsylvania,

Pennsylvania, PA,

USA

Search Strategy Group

4


from Penn Partners in Healthy Living, a consumer

membership for older

adults) with and without sleepiness (2001-2005).

Recruited an equal number

of study participants for each decile of the

multivariable apnea

prediction (MAP)

instrument. Exclusion

criteria: unable to speak English, cognitive

impairment, alcoholism,

use of sedative hypnotics, medical conditions that

would alter breathing

pattern (e.g. stroke, CHF), prior OSA diagnosis or

treatment, had Cheyne-

Stokes or primary central sleep apnea.


Male: 34%

BMI: 30.5 ±7.6 kg/m2


OSA (AHI ≥5 & ESS >10):

27% (22/92)

92 Phase testing:

1. MAP (multivariate

apnea

prediction instrument)

and/or apnea

symptoms and clinical

findings

2. Portable

Type IV sleep study based on

prior test

results (if “intermediate”

OSA

probability



Hypopneas: ≥50%

decrease in nasal flow with either a ≥3% oxygen

or EEG arousals

OSA: AHI ≥30/hr and ESS >10

Validation: Type I

Polysomnography

(Sandman, Embla)

•Two-stage algorithm (3

parameters): 1) MAP lower

bound below which sleep apnea could be excluded;

2) MAP upper bound above

which study participants can be assessed to have

OSA; and 3) home study

AHI cut-points (to be used in study participants with

intermediate MAP values)

above which study

participants can be assessed

to have OSA.

• • • • • • • • • • • • • ˚ • ˚ 14


54

No OSA: 73% (70/92)

* Abbreviations: O (No), • (Yes), afib (atrial fibrillation), AHI (apnea-hypopnea index), AASM (American Academy of Sleep Medicine), ASA (American Society of Anesthesiologists), BMI (body mass index), BQ (Berlin

questionnaire), CABG (coronary artery bypass graft), CAD (coronary artery disease), CHF (congestive heart failure), COPD (chronic obstructive pulmonary disease), CPAP (continuous positive airway pressure), CSA (central sleep

apnea), CV (cardiovascular), DM (diabetes mellitus), ECG (electrocardiograph), EEG (electroencephalographic arousal), EF (ejection fraction), ESS (Epworth sleepiness scale), FOSQ (functional outcomes sleep questionnaire),

GFR (glomerular filtration rate), GOLD (global initiative for COPD), hr (hour), IIH (idiopathic intracranial hypertension), IQR (interquartile range), NA (not applicable), NIPPV (noninvasive positive airway pressure), NR (not reported), Num (number), MAPI (multivariate apnea prediction index), MI (myocardial infarction), ODI (oxygen desaturation index), OSA (obstructive sleep apnea), PaCO2 (arterial partial pressure of carbon dioxide), PAP

(positive airway pressure), PLMS (periodic limb movements of sleep), PSG (polysomnography), RERA (respiratory effort related arousal), RDI (respiratory disturbance index), RLS (restless legs syndrome), SDB (sleep disordered

breathing), VA (veterans administration)


55

Table 6. Studies on AHRQ Key Question 3 – What is the effect of preoperative screening for OSA on surgical outcomes: Study Characteristics

Author, Year,

Study, Reference


Comments

Outcome(s)

1. Singh, 2013;

University Health

Network, Toronto,

ON, Canada

Search Strategy

Group 3

Adult (age >18) patients

visiting two preoperative

surgery clinics were

recruited. Excluded patients

expected to have abnormal

EEG findings (e.g. brain

tumors, epilepsy patients,

patients with deep brain

stimulators). October 2005 to

November 2009.

Anaesthetists and surgeons

blinded to preoperative sleep

study and Berlin

Questionnaire

819 Age: 59 (median; IQR

50,68)

Male: 48%

BMI: 29.1 kg/m2

(median; IQR 25.6-

33.4)

ESS: NR

AHI: NR

OSA (AHI ≥5/hr) :

69% (465/819)

AHI: sum of

apneas and

hypopneas per hour

of sleep

Hypopneas: >30 to

90% decrease in

nasal flow with a

>4% oxygen

desaturation

OSA: AHI ≥5/hr

•Of 267 preoperative patients with undiagnosed symptomatic moderate-

severe OSA (AHI ≥15/hr), 92% were unidentified by surgeons and 60% by

anaesthetists prior to surgery.

•Anesthesiologists did not identify 76% of those with mild, 65% moderate

and 53% with severe OSA prior to surgery – 60% of those with moderate-

severe OSA. 69.2% of those missed complained of snoring, daytime

sleepiness or witnessed apneas. 92.5% of those missed were classified as

high-risk by the STOP-BANG questionnaire.

•Surgeons did not identify 97% of those with mild, 93% moderate and 90%

with severe OSA prior to surgery – 92% of those with moderate-severe OSA.

94.9% of those missed complained of snoring, daytime sleepiness or

witnessed apneas. 93.1% of those missed were classified as high-risk by the

STOP-BANG questionnaire.

2. Kim, 2012;

Samsung Medical

Centre,

Sungkyunkwan

University, School

of Medicine,

South Korea

Search Strategy

Group 4

Men (age 40 to 75 years)

undergoing spinal anesthesia for

transurethral resection of the

bladder or prostate (ASA

physical status 1-2) were

recruited. Exclusion criteria:

ECG or chest radiographic

abnormalities, prior OSA

diagnosis or taking a medication

that might affect sleep pattern.

ApneaLink (Type IV monitor)

was recorded and auto-analyzed

AHI-indexes during propofol

sedation for surgery/.

29 Age: NR

Male: 100%

BMI: NR

ESS: NR

AHI: 17/hr (median;

IQR 0 to 70)

OSA (AHI ≥10/hr) :

66% (19/29)

AHI: sum of

apneas and

hypopneas per hour

of sleep

Hypopneas: >50%

decrease in nasal

flow

OSA: AHI ≥10/hr

•Presence or severity of OSA did not ‘significantly’ affect spinal anesthesia

level, BIS, monitoring time, analysis time, propofol infusion, intra-

operative blood pressure, heart rate and oxygen saturation score.

* * Abbreviations: O

(No), • (Yes), afib (atrial fibrillation), AHI (apnea-hypopnea index), AASM (American Academy of Sleep Medicine), ASA (American Society of

Anesthesiologists), BMI (body mass index), BQ (Berlin questionnaire), CABG (coronary artery bypass graft), CAD (coronary artery disease), CHF (congestive heart failure), COPD

(chronic obstructive pulmonary disease), CPAP (continuous positive airway pressure), CSA (central sleep apnea), CV (cardiovascular), DM (diabetes mellitus), ECG

(electrocardiograph), EEG (electroencephalographic arousal), EF (ejection fraction), ESS (Epworth sleepiness scale), FOSQ (functional outcomes sleep questionnaire), GFR (glomerular

filtration rate), GOLD (global initiative for COPD), hr (hour), IIH (idiopathic intracranial hypertension), IQR (interquartile range), NA (not applicable), NIPPV (noninvasive positive


56

airway pressure), NR (not reported), Num (number), MAPI (multivariate apnea prediction index), MI (myocardial infarction), ODI (oxygen desaturation index), OSA (obstructive sleep

apnea), PaCO2 (arterial partial pressure of carbon dioxide), PAP (positive airway pressure), PLMS (periodic limb movements of sleep), PSG (polysomnography), RERA (respiratory

effort related arousal), RDI (respiratory disturbance index), RLS (restless legs syndrome), SDB (sleep disordered breathing), VA (veterans administration)


57

Table 7. Studies on AHRQ Key Question 4 – In adults screened for OSA, what is the relationship between OSA with respect to long-term clinical and functional outcomes? :

Study Characteristics

Author, Year,

Study, Reference


Comments

Outcome(s)

1. Ensrud, 2012;

Minneapolis

Veterans Affairs

Health Care

System,

Minneapolis, MN,

USA

Search Strategy

Group 4

Study subjects were

participants in the MrOS

Longitudinal Sleep Study

conducted 2003-2005

(ancillary study to identify

outcomes of sleep disorders

in older men). Inclusion

criteria: age ≥65 years,

classifies as “non-frail” at

baseline; Exclusion criteria:

missing repeat frailty status.

Objective: “test the

hypothesis that non-frail

older men with poorer sleep

at baseline are at increased

risk of frailty and death at

follow-up”

2,505 Age: 75.7 ±5.2 years

Male: 100%

BMI: 27.2 ±3.7 kg/m2

ESS: NR (12% had

ESS >10)

AHI: NR

OSA (AHI ≥30/hr) :

9% (209/2505)

AHI: sum of

apneas and

hypopneas per hour

of sleep

Hypopneas: >30%

decrease in nasal

flow with a >4%

oxygen

desaturation

OSA: AHI ≥30/hr

Sleep Study: Type

2 Polysomnogram

(in-home,

unattended)

•Severe OSA was associated with increased risk of death at follow-up

(multivariable OR 1.74, 95% CI 1.04-2.89).

2. Chami, 2011;

Boston University

School of

Medicine, Boston,

USA

Search Strategy

Group 4

Population cohort study

(Sleep Heart Health Study) of

adults (age ≥40 years)

recruited in several ongoing

cohort studies of

cardiovascular and

pulmonary disease in USA.

Excluded patients who had

surgery for OSA.

819 Age: 61.9 ±10.2 years

Male: 43%

BMI: 28.7 ±5.3 kg/m2

ESS: NR

AHI: NR

OSA (AHI ≥5/hr) :

NR

AHI: sum of

apneas and

hypopneas per hour

of sleep

Hypopneas: >30%

decrease in nasal

flow with a >3%

oxygen

desaturation

OSA: AHI ≥5/hr

•Patients with incident cardiovascular disease (over 5-years) experienced

larger increases in AHI between PSG’s

3. Fung, 2011;

San Diego

Veterans Affairs

Healthcare

System, San

Diego, CA, USA

Study subjects were

participants in the MrOS

Longitudinal Sleep Study

conducted 2003-2005

(ancillary study to identify

outcomes of sleep disorders

784 Age: 75.1 ±4.9 years

Male: 100%

BMI: 26.4 ±3.4 kg/m2

ESS: NR

AHI: 10.0 ±12.0/hr

OSA (AHI ≥5/hr) :

AHI: sum of

apneas and

hypopneas per hour

of sleep

Hypopneas: >30%

decrease in nasal

•No statistically significant difference with incident HTN with respect

to baseline RDI.


58

Search Strategy

Group 4

in older men). Objective was

to assess whether incident

hypertension is associated

with polysomnography

measures of sleep disordered

breathing in older men.

Inclusion criteria: age ≥65

years. Exclusion criteria:

hypertension.

54% (423/784) flow with a >4%

oxygen

desaturation

OSA: AHI ≥5/hr

Sleep Study: Type

2 Polysomnogram

(in-home,

unattended)

* Abbreviations: O

(No), • (Yes), afib (atrial fibrillation), AHI (apnea-hypopnea index), AASM (American Academy of Sleep Medicine), ASA (American Society of Anesthesiologists),

BMI (body mass index), BQ (Berlin questionnaire), CABG (coronary artery bypass graft), CAD (coronary artery disease), CHF (congestive heart failure), COPD (chronic obstructive

pulmonary disease), CPAP (continuous positive airway pressure), CSA (central sleep apnea), CV (cardiovascular), DM (diabetes mellitus), ECG (electrocardiograph), EEG

(electroencephalographic arousal), EF (ejection fraction), ESS (Epworth sleepiness scale), FOSQ (functional outcomes sleep questionnaire), GFR (glomerular filtration rate), GOLD

(global initiative for COPD), hr (hour), IIH (idiopathic intracranial hypertension), IQR (interquartile range), NA (not applicable), NIPPV (noninvasive positive airway pressure), NR

(not reported), Num (number), MAPI (multivariate apnea prediction index), MI (myocardial infarction), ODI (oxygen desaturation index), OSA (obstructive sleep apnea), PaCO2

(arterial partial pressure of carbon dioxide), PAP (positive airway pressure), PLMS (periodic limb movements of sleep), PSG (polysomnography), RERA (respiratory effort related

arousal), RDI (respiratory disturbance index), RLS (restless legs syndrome), SDB (sleep disordered breathing), VA (veterans administration)


59

Table 8 - AHRQ Question 1a – Summary of Type II Portable Sleep Study Diagnostic Studies

Study Search

Strategy

Sample Demographics N Index/Validation OSA Definition OSA Prevalence Portable

Cut-

point(s)

PSG

Cut-Point(s)

Ferre, 2012 Group 3 Consecutive

patients referred to

a sleep unit for

suspected sleep

apnea

Age: 55.9

±14.5 years

Male: 57%

BMI: 28.5 ±4.8

kg/m2

ESS: 8.6 ±9.5

AHI: 21.7

±19.0/hr

68 •Type II Portable Study

(Somte polygraph,

Compumedics)

•Type I

Polysomnography

AHI: sum of apneas

and hypopneas per

hour of sleep

Hypopneas: ≥50

decrease in nasal flow

with either a ≥3%

oxygen desaturation or

an arousal

OSA: AHI ≥5/hr


(13/68)

OSA (AHI ≥5):: 81%

(55/68)

•Mild (AHI 5-15): 28%

(19/68)

•Moderate (AHI 15-30):

26% (18/68)

•Severe (AHI ≥30): 26%

(18/68)

Various:

AHI

>5/hr

AHI

>15/hr

AHI

>30/hr

Various:

AHI >5/hr

AHI

>15/hr

AHI

>30/hr

Oliveria,

2012

Group 4 Consecutive

COPD patients

with suspected

OSA

•High rate of

inadequate

portable Type II

study recordings

reported (26 out of

67)

Age: 62.8 ±8.5

years

Male: 50%

BMI: 31.0 ±5.6

kg/m2

ESS: 10.5 ±4.1

AHI: 23.0

±3.5/hr


(Stardust II, Philips-

Respironics)

•Type I

Polysomnography

(Embla N7000)

AHI: NR

Hypopneas: ≥50%


OR a <50% reduction

in nasal flow

associated with either

≥3% oxygen

desaturation or an

EEG arousal

OSA: AHI ≥5/hr

No OSA (AHI <5): NR

OSA (AHI ≥5): NR (90%

of enrolled patients had an

AHI ≥5/hr; 41 of these

were excluded from the

final analysis)

Various:

AHI >5-

15/hr

AHI

>30/hr

Various:

AHI >5-

15/hr

AHI

>30/hr

Bruyneel,

2011

Group 4 Consecutive


a sleep unit for

suspected sleep

apnea

Age: 48.9

±12.1 years

Male: 59%

BMI: 30.5 ±7.3

kg/m2

ESS: NR

AHI: 26.4

±30/hr


(Pamela V 3.631,

Medatec)

•Type I

Polysomnography

(Medatec)

AHI: sum of apneas

and hypopneas per

hour of sleep

Hypopneas: ≥50%


with either a ≥3%


EEG arousal

OSA: AHI ≥5/hr


(14/66)

OSA (AHI ≥5): 77%

(48/66)

•Mild (AHI 5-15): 42%

(20/48)


23% (11/48)


(17/48)

Various:

AHI

>5/hr

AHI

>15/hr

AHI

>30/hr

Various:

AHI >5/hr

AHI

>15/hr

AHI

>30/hr

Campbell, Group 4 Consecutive Age: 49.1 30 •Type II Portable Study AHI: sum of apneas No OSA (AHI <5): 20% Various: Various:


60

2011 patients referred to

a sleep unit for

suspected sleep

apnea

±13.8 years

Male: 80%

BMI: 31.0 ±6.1

kg/m2

ESS: NR

AHI: 34.5

±29.0/hr

(Siesta System,

Compumedics)

•Type I

Polysomnogram

(S=series,

Compumedics)

and hypopneas per

hour of sleep

Hypopneas: A visible


and either a ≥3%


an EEG arousal

OSA: AHI ≥5/hr

(6/30)

OSA (AHI ≥5): 80%

(24/30)

•Mild (AHI 5-15): 29%

(7/24)

•Moderate/Severe (AHI

≥15): 71% (17/24)

AHI

>5/hr

AHI

>10/hr

AHI

>15/hr

AHI >5/hr

AHI

>10/hr

AHI

>15/hr

* Abbreviations: AHI (apnea-hypopnea index), BMI (body mass index), CABG (coronary artery bypass graft), CAD (coronary artery disease), COPD (chronic obstructive

pulmonary disease), CPAP (continuous positive airway pressure), DM (diabetes mellitus), EEG (electroencephalogram), ESS (Epworth sleepiness scale), hr (hour), IQR

(interquartile range), MI (myocardial infarction), N (number), NR (not reported), OSA (obstructive sleep apnea), OSAS (obstructive sleep apnea syndrome), mod (moderate), PSG

(polysomnogram), RDI (respiratory disturbance index), RERA (respiratory effort related arousal), SDB (sleep disordered breathing)


61

Table 9 - AHRQ Question 1a – Diagnostic Accuracy of Type II Portable Sleep Study Diagnostic Studies

Study N Cut-Point OSA

Prevalence

Population TP FN FP TN Diagnostic

Odds Ratio

p-

value

Sens Spec PPV NPV +LR -LR Accuracy AUC Pos

Posttest

Probability

Neg

Posttest

Probability

Kappa(1)

Coefficient

Ferre, 2012 68 PSG: AHI ≥5/hr

Type II Study: AHI

≥5/hr

0.809 Sleep clinic patients

with suspected OSA

50 5 3 10 33.3 <0.001 0.909 0.769 0.943 0.667 3.94 0.118 0.882 0.81 0.943 0.333 0.704

68 PSG: AHI ≥15/hr

Type II Study: AHI

≥15/hr


with suspected OSA

31 5 1 31 192.2 <0.001 0.861 0.969 0.969 0.861 27.56 0.143 0.912 0.91 0.969 0.139 0.934


Type II Study: AHI

≥30/hr


with suspected OSA

11 7 2 48 <0.001 0.611 0.960 0.846 0.873 15.29 0.405 0.868 0.86 0.846 0.127

Oliveria, 2012 26 PSG: AHI 5-15/hr

Type II Study: AHI 5-

15/hr

NR COPD patients with

suspected OSA

. . . . . . . . . . . . . . . 0.350


Type II Study: AHI

≥30/hr

NR COPD patients with

suspected OSA

. . . . . . . . . . . . . . . 0.560

Bruyneel,

2011

66 PSG: AHI ≥5/hr

Type II Study: AHI

≥5/hr


with suspected OSA

45 3 9 5 8.33 0.004 0.938 0.357 0.833 0.625 1.458 0.175 0.806 NR 0.833 0.375 0.262


Type II Study: AHI

≥15/hr


with suspected OSA

22 6 10 24 8.80 <0.001 0.786 0.706 0.688 0.800 2.671 0.304 0.742 NR 0.688 0.200 0.430


Type II Study: AHI

≥30/hr


with suspected OSA

13 4 1 44 <0.001 0.765 0.978 0.929 0.917 34.41 0.241 0.919 NR 0.929 0.083

Campbell,

2011

30 PSG: AHI ≥5/hr

Type II Study: AHI

≥5/hr


with suspected OSA

21 3 1 1 128.0 0.092 0.875 0.500 0.955 0.250 1.750 0.250 0.733 0.900 0.875 0.500 0.409


Type II Study: AHI

≥10/hr


with suspected OSA

19 2 1 8 <0.001 0.905 0.889 0.950 0.800 8.143 0.107 0.900 0.921 0.950 0.l200


Type II Study: AHI

≥15/hr


with suspected OSA

16 1 3 10 384.0 <0.001 0.941 0.769 0.842 0.909 4.078 0.076 0.867 0.942 0.842 0.091 0.636

* Abbreviations: +LR (positive likelihood ratio), -LR (negative likelihood ratio), AHI (apnea-hypopnea index), AUC (area under the curve), CABG (coronary artery bypass graft), CAD (coronary artery disease), COPD (chronic

obstructive pulmonary disease), CPAP (continuous positive airway pressure), FN (false negative), FP (false positive), N (number), NR (not reported), NPV (negative predictive value), MI (myocardial infarction), OSA (obstructive sleep apnea), OSAS (obstructive sleep apnea syndrome), PPV (positive predictive value), PSG (polysomnogram), RDI (respiratory disturbance index), Sen (sensitivity), Spec (specificity), TN (true negative), TP (true positive)


62

Table 10 - AHRQ Question 1a – Summary of Type III Portable Sleep Study Diagnostic Studies

Study Search

Strategy


Cut-point(s)

PSG

Cut-

Point(s)

Danzi-

Soares,

2012

Group 3 Consecutive

patients

referred for

CABG

Age: 58 ±7 years

Male: 76%

BMI: 27.6 ±27.6

ESS: 7 (range 5-

11)

AHI: 22.9 ±20.0

70 •Type III portable study

(Stardust II, Respironics)

•Type I Polysomnography


hypopneas per hour of

sleep



with a >3% oxygen

desaturation

OSA: AHI ≥5/hr

No OSA (AHI <5/hr):

12.9% (9/70)

OSA (AHI ≥5/hr):

87.1% (61/70)

•Mild (AHI 5-15):

32.9% (23/70)


30): 27.1% (19/70)


27.1% (19/70)

Various:

AHI >5/hr

AHI >15/hr

Various:

AHI

>5/hr

AHI

>15/hr

Cheliout-

Heraut,

2011

Group 4 Patients with

suspected

OSA based

on daytime

sleepiness

and snoring

Age: 55.4 ±8.7

years

BMI: NR

Male: 67%

ESS: NR

AHI: NR

90 • Type III portable study

(Somnolter device,

Nomics) – automated

scoring

• Type 1

Polysomnography

(Embla)



sleep

Hypopneas: either ≥50

decrease in nasal flow OR

≥30 decrease in nasal

flow and either a ≥3%


EEG arousal

OSA: AHI ≥5/hr

No OSA (AHI <5/hr):

8% (7/90)


(83/90)

•Mild (AHI 5-15):

25% (21/83)


30): 34% (28/83)


41% (34/83)

AHI >5/hr

AHI

>5/hr

Driver,

2011

Group 4 Patients

referred to a

sleep lab for

diagnostic

sleep testing

Age: 52.9 ±12.2

years

BMI: 32.2 ±6.8

kg/m2

Male: 41%

ESS: NR

AHI: 26.0

±25.9/hr

73 • Type III portable study

(MediByte)

•Type 1

Polysomnography



sleep



a ≥3% oxygen

desaturation AND an

EEG arousal

OSA: AHI ≥5/hr

No OSA (AHI <5/hr)

16% (12/73)


(61/73)

•Mild (AHI 5-15):

28% (17/61)


30): 34% (21/61)


38% (23/61)

Various:

AHI >5/hr

AHI >10/hr

AHI >15/hr

AHI >20/hr

AHI >30/hr

Various:

AHI

>5/hr

AHI

>10/hr

AHI

>15/hr

AHI

>20/hr

AHI

>30/hr

Gjevre, Group 4 Consecutive Age: 52 ±11.0 47 •Type III portable study AHI: sum of apneas and No OSA (AHI <5/hr): Various: AHI


63

2011 adult (age 21

to 70 years)

women

scheduled

for routine

PSG to

evaluate

clinically

suspected

OSA

years

Male: 100%

BMI: 34.9 ±9.0

kg/m2

ESS: 9.6 ±4.4

AHI: 15.1

±16.3/hr

(Embletta 2601-1)



sleep

Hypopneas: ≥50 decrease

in nasal flow and a ≥3%

oxygen desaturation

OSA: AHI ≥5/hr

32% (15/47)


(32/47)

•Mild/Mod (AHI 5-

30): 75% (24/47)

•Severe (AHI ≥30):

25% (8/47)

AHI >5/hr

AHI >10/hr

AHI >15/hr

AHI >20/hr

AHI >30/hr

>5/hr

Masa,

2011

Group 4 Sleep clinic

patients with

suspected

OSA

Age: 48.7 ±11.8

years

Male: 76%

BMI: 31.0

±6.6kg/m2

ESS: 11.6 ±5

AHI: 38.3

±28.5/hr

348 •Type III sleep study

(BreastSC20 or Breat

Medial AB)




sleep

Hypopneas: ≥30%

decrease in airflow and

either ≥3% oxygen


arousal

OSA: AHI ≥5/hr

No OSA (AHI <5/hr)

9% (33/348)


(315/348)

•Mild (AHI 5-15):

37% (129/315)


30): 12% (42/215)


41% (144/315)

Various:

AHI >5/hr

AHI >10/hr

AHI >15/hr

AHI >20/hr

AHI >25/hr

Various:

AHI

>5/hr

AHI

>10/hr

AHI

>15/hr

* Abbreviations: AHI (apnea-hypopnea index), BMI (body mass index), CABG (coronary artery bypass graft), CAD (coronary artery disease), COPD (chronic obstructive

pulmonary disease), CPAP (continuous positive airway pressure), DM (diabetes mellitus), EEG (electroencephalogram), ESS (Epworth sleepiness scale), hr (hour), IQR

(interquartile range), MI (myocardial infarction), N (number), NR (not reported), OSA (obstructive sleep apnea), OSAS (obstructive sleep apnea syndrome), mod (moderate),

PSG (polysomnogram), RDI (respiratory disturbance index), RERA (respiratory effort related arousal), SDB (sleep disordered breathing)


64

Table 11 - AHRQ Question 1a – Diagnostic Accuracy of Type III Portable Sleep Study Diagnostic Studies


Prevalence


Odds Ratio

p-

value

Sens Spec PPV NPV +LR -LR Accuracy AUC Pos Posttest

Probability

Neg Posttest

Probability

Kappa(1)

Coefficient

Danzi-Soares, 2012 70 •PSG: AHI ≥5/hr

•Type III Study: AHI

≥5/hr

0.871 CABG patients 56 5 3 6 22.40 <0.001 0.918 0.667 0.949 0.545 2.754 0.123 0.886 0.900 0.949 0.455 0.605

70 •PSG: AHI ≥15/hr


≥15/hr

0.543 CABG patients 25 13 7 25 <0.001 0.658 0.781 0.781 0.658 3.01 0.520 0.714 0.790 0.781 0.342

Cheliout-Heraut,

2011



≥5/hr


with suspected OSA

69 14 1 6 29.57 <0.001 0.831 0.857 0.986 0.300 5.819 0.197 0.833 NR 0.986 0.700 0.816

Driver, 2011 73 •PSG: AHI ≥5/hr


≥5/hr

0.836 Sleep clinic patients 59 2 4 8 22.59 <0.001 0.967 0.667 0.937 0.800 2.902 0.049 0.918 0.940 0.937 0.200 0.614



≥15/hr

0.603 Sleep clinic patients 35 9 1 28 <0.001 0.795 0.966 0.972 0.757 23.07 0.212 0.863 0.926 0.972 0.243



≥30/hr

0.315 Sleep clinic patients 16 7 0 50 <0.001 0.696 1.00 1.00 0.877 NA 0.304 0.904 0.870 NA 0.123

Gjevre, 2011 47 •PSG: AHI ≥5/hr


≥5/hr


with suspected OSA

31 1 6 9 30.69 <0.001 0.969 0.600 0.838 0.900 2.42 0.052 0.851 0.879 0.838 0.100 0.492

Masa, 2011 348 •PSG: AHI ≥5/hr


≥5/hr


with suspected OSA

302 13 14 19 30.13 <0.001 0.959 0.576 0.956 0.594 2.260 0.072 0.922 0.917 0.956 0.406 0.533



≥5/hr


with suspected OSA

274 41 5 28 <0.001 0.870 0.848 0.982 0.406 5.741 0.153 0.868 0.917 0.982 0.594



≥10/hr


with suspected OSA

280 9 36 23 <0.001 0.969 0.390 0.886 0.719 1.588 0.080 0.871 0.883 0.886 0.281



≥20/hr


with suspected OSA

205 84 6 53 <0.001 0.709 0.898 0.972 0.387 6.975 0.324 0.741 0.883 0.972 0.613



≥10/hr


with suspected OSA

175 11 65 97 <0.001 0.941 0.599 0.729 0.898 2.345 0.099 0.782 0.891 0.729 0.102



≥25/hr


with suspected OSA

125 61 13 149 <0.001 0.672 0.920 0.906 0.710 8.375 0.357 0.787 0.891 0.906 0.290


obstructive pulmonary disease), CPAP (continuous positive airway pressure), FN (false negative), FP (false positive), N (number), NR (not reported), NPV (negative predictive value), MI (myocardial infarction), OSA (obstructive sleep apnea), OSAS (obstructive sleep apnea syndrome), PPV (positive predictive value), PSG (polysomnogram), RDI (respiratory disturbance index), Sen (sensitivity), Spec (specificity), TN (true negative), TP (true positive)


65

Table 12 - AHRQ Question 1a – Summary of Type IV Portable Sleep Study Diagnostic Studies

Study Search

Strategy


Cut-point(s)

PSG

Cut-Point(s)

Nigro, 2013 Group

4

Sleep clinic

patients with suspected OSA

Age: 48.2 ±14.5 years

Male: 69% BMI: 30 ±7.2 kg/m2

ESS: NR

RDI: 15.1/hr (median, IQR 6.3-34.6)

55 •Type IV Sleep Study

(ApneaLink Ox)


(Harmonie or MiniPC)

•Automatic analysis was also

assessed; manual scoring results reported for this report

AHI: NR


hour of sleep

Hypopneas: NR; “in agreement with international

criteria”

RERA: NR OSA: RDI ≥5/hr

OSA (RDI ≥5/hr): 78% (43/55)

No OSA (RDI <5): 22% (12/55) •Mild (RDI 5-15): 35% (15/55)

•Moderate (RDI 15-30): 30%

(13/55) •Severe (RDI ≥30): 35% (15/55)

AHI ≥5/hr RDI ≥5/hr

Morales,

2012

Group

4

Elderly patients

(population

study) with and

without sleepiness


Male: 34%

BMI: 30.5 ±7.6 kg/m2


92 •Type IV Sleep Study

(ResCare AutoSet, ResMed)

•Type I Polysomnography (Sandman, Embla)




in nasal flow with either a ≥3% oxygen or EEG

arousals


No OSA: 73% (70/92)

OSA (AHI ≥5 & ESS >10): 27%

(22/92)

•Mild (AHI 5-15 & ESS >10): 32% (7/22)

•Moderate (AHI 15-30 & ESS

>10): 23% (5/22) •Severe (AHI ≥30 & ESS >10):

45% (10/22)

AHI ≥20.9/hr AHI ≥30/hr

& ESS >10

O’Brien,

2012

Group

4

Women in third

trimester of

pregnancy


Male: 100%

BMI: 31.9 ±3.0 kg/m2 ESS: NR

AHI: 5.4 ±8.5/hr

31 •WatchPat 200 (Itamar)

•Type II Polysomnography (Medpalm)



RDI: Number of respiratory events (apnea, hypopnea,

and RERA) per hour of

sleep Hypopneas: ≥50% decrease


≥3% oxygen or EEG arousal OSA: AHI ≥5/hr

No OSA (AHI <5): 74% (23/31)

OSA (AHI ≥5): 26% (8/31)

•Mild: 63% (5/8) •Moderate: 38% (3/8)

•Severe: 0% (0/8)

Various:

AHI ≥5/hr

AHI ≥6.1/hr

Various:

AHI ≥5/hr

RDI ≥10/hr

Onder, 2012 Group

4

Sleep clinic


Age: 43.3 ±12.9 years

Male: 64% BMI: 30.5 ±4.5 kg/m2

ESS: NR

AHI: 19.3 ±23.5/hr






oxygen OSA: NR

No OSA: NR

OSA: NR

AHI ≥20/hr AHI ≥20/hr

Bahammam

2011

Group

3

Patients with

suspected OSA

Age: 46.3 ±12.6 years

BMI: 34.1 ±7.9 Male:61%

ESS:NR

AHI: 39.5 ±30.4/hr

97 •Type IV portable study

(ApneaLink)


(Alice , Respironics)




≥3% oxygen or EEG arousal OSA: AHI ≥5/hr

No OSA (AHI <5): 85% (81/95)

OSA (AHI ≥5): 15% (14/95) •Mild: 27% (22/81)

•Moderate: 22% (18/81)

•Severe: 51% (41/81)

Various:


AHI ≥15/hr

AHI ≥30/hr

Various:


AHI ≥15/hr

AHI ≥30/hr


66

Chai-

Coetzer,

2011

Group

3

Adult patients

attending six primary care

clinics

Age: 55 years (range 45-

62) Male:53%

BMI: 31.7 kg/m2 (range

28.8-36.1) ESS: 8 (range 4-10)

AHI: 20.9/hr (range 13.1-

41.3)

77 •Type IV portable study

(ApneaLink)

•Type I Polysomnogram

AHI: NR

Hypopneas: Either ≥50% decrease in nasal flow or a


an EEG arousal OSA: AHI ≥30/hr

No OSA (AHI <30): 79% (62/78)

OSA (AHI ≥30): 21% (16/78) •Mild: NR

•Moderate: NR

•Mild: NR


Chouchou,

2011

Group

4

Adult (Age ≥65

years) subjects

enrolled in the PROOF study

Age: 65.8 ±1.1years

Male: 43%

BMI: 25.4 ±4.0 kg/m2 ESS: 5.5 ±3.4

AHI: NR

780 •Pulse Transit Time (PTT)

measured on the Type 3 sleep

study –autonomic activation index (AAI) obtained from

PTT signal and broken down

into respiratory events.

• Type III Sleep Study

(HypnoPTT, Tyco Healthcare)



Hypopneas: ≥50 decrease in nasal flow and a ≥3%

oxygen desaturation

OSA: AHI ≥15/hr

No OSA (AHI <5/hr): 9% (70/780)

OSA (AHI ≥5/hr): 91% (710/780)

•Mild (AHI 5-15): 37% (263/710) •Moderate (AHI 15-30): 38%

(270/710)

•Severe (AHI ≥30): 25% (177/710)

Various:

AAI ≥32.3/hr

AAI ≥56.3/hr

Various:

AHI ≥15/hr

AHI ≥30/hr

Hedner,

2011

Group

3

Multi-center

study cohort consisting of

139 sleep clinic

patients referred for suspected

OSA, 17 normal

volunteers and 71 subjects

randomly drawn

from a population

study

Age: 49 ±14 years

BMI: 29 ±6 kg/m2 Male: NR

ESS: NR

RDI: 30 ±23/hr



RDI: Number of respiratory

events (apnea, hypopnea, and RERA) per hour of

sleep

Hypopneas: Not defined OSA: RDI ≥10/hr

No OSA: 17% (38/227)

OSA:83% (189/227) •Mild: 29% (54/189)

•Moderate: 43% (82/189)

•Severe: 28% (53/189)

RDI ≥10/hr

RDI ≥10/hr

Nigro, 2011 Group 4

Consecutive sleep clinic

patients with

suspected OSA (Mar 2008-Nov

2008).

Age: 49.6 ±15.1 years Male: 77%

BMI: 29.3 kg/m2

(median, IQR 25.2-32.5) ESS: NR

AHI: 11.8/hr (median; IQR

5.8-32.3) RDI: 13.9/hr (median,

IQR 7-34.1)

OSA (RDI ≥5): 83%

(75/90)


(15/90)

90 •Type IV sleep study (ApneaLink, Resmed)

•Type I Polysomnogram (BiOPC or NEUROTRACE)


RDI: sum of apneas,


Hypopneas: NR for PSG;

“In agreement with international criteria”

OSA: RDI ≥5/hr

No OSA (RDI <5): 27% (15/90) OSA (RDI ≥5): 83% (75/90)

Various: AHI ≥5/hr

AHI ≥10/hr


AHI ≥30/hr

Various: RDI ≥5/hr

RDI ≥10/hr

RDI ≥15/hr RDI ≥20/hr

RDI ≥30/hr

Yang, 2011 Group

4

Chinese sleep

clinic patients

Age: 50.3 ±14.8 years

Male: 70%

86 •Type IV sleep study

(Oximetry and RIP-derived



No OSA (AHI <5): 37% (32/86)

OSA (AHI ≥5): 63% (54/86)

Various:

AHI ≥5/hr

Various:

AHI ≥5/hr


67

BMI: 26.8 ±5.7 kg/m2

ESS: 8.0 ±4.6 AHI: 18.5 ±19.7/hr

X-flow)


(Embla A10)


in airflow and either ≥4% oxygen desaturation or an

EEG arousal

OSA: AHI ≥5/hr

•Mild (AHI 5-15): 24% (13/54)

•Moderate (AHI 15-30): 39% (21/54)

•Severe (AHI ≥30): 37% (20/54)

AHI ≥15/hr

AHI ≥15/hr

Alvarez,

2010

Group

3

Symptomatic



Male: 78% BMI: 29.8 ±5.6 kg/m2

ESS: NR

AHI: 29.0 ±28.5/hr

148 • Type IV sleep study

(Oximetry [sampling rate 1 Hz] and airflow derived from

PSG


(Alice 5, Respironics)

•Relationship between

changes in airflow and SpO2

(particularly peak amplitude and relative power in the very

low frequency band) were

analyzed via magnitude squared coherence function to

predict AHI

•Logistic regression was

performed on common

oximetry statistics in the time and frequency domains,

conventional spectral

characteristics from the

power spectral density

function and nonlinear

features. Variables assessed in model: relative power (PR),

fourth order statistical

moments in the time domain (M4t), Lempel-Ziv

complexity (LZC), second

order statistical moments in the time domain(M2t)

AHI: “sum of apneas and




OSA: AHI ≥10/hr


(48/148) OSA (AHI ≥10/hr): 68% (100/148)

Peak

amplitude (PA), and

Relative

Power (PR) assessed for

SpO2, flow

and magnitude

squared

coherence;

relative power (PR), fourth

order

statistical moments in

the time

domain (M4t), Lempel-Ziv

complexity

(LZC), second order

statistical

moments in

the time

domain(M2t)

AHI ≥10

Nigro, 2010 Group

4

Consecutive

sleep clinic patients with

suspected OSA

(July 2007-Nov2007).

Age: 51.6 ±14.1 years

Male: 71% BMI: 29.3 ±5.4 kg/m2

ESS: NR


RDI: 10.6/hr (median,

IQR 5.4-34.1)


(ApneaLink, Resmed)


(BIOPC or NEUROTRACE, Akonic)


hypopneas per hour of sleep RDI: sum of apneas,


hour of sleep Hypopneas: Discernible

decrease in airflow and

either ≥3% oxygen RERA: an EEG arousal

No OSA (RDI <5): 23% (15/66)

OSA (RDI ≥5): 77% (51/66) •Mild (RDI 5-15): 39% (20/51)


(14/51) •Severe (RDI ≥30): 33% (17/51)

Various:


AHI ≥15/hr

AHI ≥30/hr

Various:

RDI ≥5/hr RDI ≥10/hr

RDI ≥15/hr

RDI ≥30/hr


68

associated with an alteration

of the inspiratory contour in the waves from the

thoracoabdominal bands

OSA: RDI ≥5/hr

Yadollahi,

2010

Group

4

Sleep clinic

patients

Age: 51.4 ±11.9 years

Male: 71%

BMI: 31.9 ±6.4 kg/m2 ESS: NR

AHI: 23.6 ±30.3/hr


(Oximetry and tracheal sound

signals)





No OSA: NR

OSA: NR

Various:

AHI ≥8.6/hr

AHI ≥13.0/hr AHI ≥18.5/hr

AHI ≥23.0/hr

Various:

AHI ≥5/hr


AHI ≥20/hr

* Abbreviations: AHI (apnea-hypopnea index), BMI (body mass index), CABG (coronary artery bypass graft), CAD (coronary artery disease), COPD (chronic obstructive pulmonary disease), CPAP (continuous

positive airway pressure), DM (diabetes mellitus), EEG (electroencephalogram), ESS (Epworth sleepiness scale), hr (hour), IQR (interquartile range), MI (myocardial infarction), N (number), NR (not reported), OSA

(obstructive sleep apnea), OSAS (obstructive sleep apnea syndrome), mod (moderate), PSG (polysomnogram), RDI (respiratory disturbance index), RERA (respiratory effort related arousal), SDB (sleep disordered

breathing)


69

Table 13 – AHRQ Question 1a – Diagnostic Accuracy of Type IV Portable Sleep Study Diagnostic Studies


Prevalence

Population TP FN FP TN p-value Sens Spec PPV NPV +LR -LR Accuracy AUC Pos Posttest

Probability

Neg Posttest

Probability

Nigro, 2013 55 •PSG: AHI ≥5/hr •Type IV Study: RDI

≥5/hr

0.782 Patients with suspected OSA

40 3 1 11 <0.001 0.930 0.917 0.976 0.786 11.16 0.076 0.927 0.923 0.976 0.214

O’Brien,

2012

31 •PSG: AHI ≥5/hr •WatchPAT: AHI

≥5/hr

0.258 Pregnant Women 7 1 3 20 <0.001 0.875 0.870 0.700 0.952 6.708 0.144 0.871 0.960 0.700 0.048


•WatchPAT: AHI ≥6.1/hr

0.258 Pregnant Women 7 1 2 21 <0.001 0.875 0.913 0.778 0.955 10.063 0.137 0.903 0.960 0.778 0.045

31 •PSG: RDI ≥10/hr

•WatchPAT: RDI ≥10/hr

0.258 Pregnant Women 5 0 5 21 <0.001 1.000 0.808 0.500 1.000 5.200 0.000 0.839 0.940 0.500 0.000

Morales,

2012

92 •PSG: RDI ≥20.9/hr

•Type IV Study: AHI ≥30/hr & ESS >10

0.109 Elderly patients

with and without daytime sleepiness

8 2 21 61 <0.001 0.800 0.744 0.276 0.968 3.124 0.269 0.750 0.791 0.276 0.032

Onder, 2012 59 •PSG: AHI ≥20/hr

•WatchPAT: AHI ≥20/hr

0.375 Sleep clinic


15 6 5 33 <0.001 0.714 0.868 0.750 0.846 5.429 0.329 0.857 NR 0.765 0.165

BaHammam,

2011


•Type IV Study: AHI

≥5/hr

0.853 Patients with

suspected OSA

81 0 8 6 <0.001 1.00 0.429 0.910 1.00 1.75 0.000 0.916 0.971 0.910 0.000


•Type IV Study: AHI ≥15/hr

0.621 Patients with

suspected OSA

58 1 15 21 <0.001 0.983 0.583 0.795 0.955 2.359 0.029 0.832 0.924 0.795 0.045



≥30/hr

0.432 Patients with

suspected OSA

41 0 11 43 <0.001 1.00 0.796 0.788 1.00 4.91 0.000 0.884 0.997 0.788 0.000

Chai-Coetzer,

2011



≥30/hr

0.210 Primary care

clinic patients

. . . . . . . . . . . . 0.950 . .

Chouchou,

2011


•Type IV Study: AAI

≥32.3/hr

0.573 Elderly patients 315 132 151 182 <0.001 0.705 0.547 0.676 0.580 1.554 0.540 0.637 0.670 0.676 0.420


•Type IV Study: AAI

≥56.3/hr

0.227 Elderly patients 57 120 32 571 <0.001 0.322 0.947 0.640 0.826 6.068 0.716 0.805 0.740 0.640 0.174

Hedner, 2011 227 •PSG: RDI ≥10/hr NR Suspected OSA, . . . . . . . . . . . . 0.960 . .


70

• WatchPAT: RDI

≥10/hr

healthy volunteers

and population study subjects

Nigro, 2011 90 •PSG: RDI ≥5/hr


0.833 Sleep clinic

patients

67 8 2 13 <0.001 0.893 0.867 0.971 0.619 6.700 0.123 0.889 0.880 0.971 0.381



≥10/hr

0.744 Sleep clinic

patients

49 18 2 21 <0.001 0.731 0.913 0.961 0.538 8.410 0.294 0.778 0.822 0.961 0.462



≥15/hr

0.478 Sleep clinic

patients

31 12 1 46 <0.001 0.721 0.979 0.969 0.793 33.88 0.285 0.856 0.850 0.969 0.207

90 •PSG: RDI ≥20/hr •Type IV Study: AHI

≥20/hr


29 4 1 56 <0.001 0.879 0.982 0.967 0.933 50.09 0.123 0.944 0.931 0.967 0.067


≥30/hr


22 4 1 63 <0.001 0.846 0.984 0.957 0.940 54.15 0.156 0.944 0.915 0.957 0.060

Yang, 2011 86 •PSG: AHI ≥5/hr •Type IV Study: AHI

≥5/hr

0.628 Chinese sleep clinic patients

53 1 0 32 <0.001 0.981 1.000 1.000 0.970 NA 0.019 0.988 NR NA 0.030



0.477 Chinese sleep

clinic patients

35 6 1 44 <0.001 0.854 0.978 0.972 0.880 38.41 0.150 0.919 NR 0.972 0.120

Alvarez, 2010 148 •PSG: AHI ≥10/hr •Type IV Study:

PAFlow

0.676 Symptomatic patients with

suspected OSA

84 16 7 41 <0.001 0.840 0.854 0.923 0.719 5.760 0.187 0.845 0.904 0.923 0.281


•Type IV Study: PFlow

0.676 Symptomatic


68 32 13 32 <0.001 0.680 0.729 0.840 0.522 2.511 0.439 0.696 0.739 0.840 0.478


•Type IV Study: PAMSC

0.676 Symptomatic


81 19 7 41 <0.001 0.810 0.854 0.920 0.683 5.554 0.222 0.824 0.903 0.920 0.317


•Type IV Study: PMSC

0.676 Symptomatic

patients with

suspected OSA

77 23 7 41 <0.001 0.770 0.854 0.917 0.641 5.280 0.269 0.797 0.884 0.917 0.359

Nigro, 2010 66 •PSG: RDI ≥5/hr


≥5/hr

0.773 Patients with

suspected OSA

45 6 2 13 <0.001 0.882 0.867 0.957 0.684 6.618 0.136 0.879 0.875 0.957 0.316



≥10/hr

0.545 Patients with

suspected OSA

32 4 3 27 <0.001 0.889 0.900 0.914 0.871 8.889 0.123 0.894 0.890 0.914 0.129


≥15/hr


29 2 3 32 <0.001 0.935 0.914 0.906 0.941 10.91 0.071 0.924 0.925 0.906 0.059

66 •PSG: RDI ≥30/hr 0.258 Patients with 17 0 5 44 <0.001 1.000 0.898 0.773 1.000 9.800 0.000 0.924 NR 0.773 0.000


71


≥30/hr

suspected OSA


≥5/hr


found to have mild

or no OSA

15 5 2 13 <0.001 0.750 0.867 0.882 0.722 5.625 0.288 0.424 NR 0.710 0.111



≥15/hr

0.286 Patients with

suspected OSA

excluding those found to have

severe OSA

12 2 3 32 <0.001 0.857 0.914 0.800 0.941 10.00 0.156 0.898 NR 0.800 0.059

Yadollahi,

2010

66 •PSG: AHI ≥5/hr •Type IV Study: AHI

≥8.6/hr

NR Sleep clinic patients

. . . . . 0.743 0.824 . . . . . 0.870 . .



NR Sleep clinic

patients

. . . . . 0.828 0.911 . . . . . 0.950 . .


•Type IV Study: AHI ≥18.5/hr

NR Sleep clinic

patients

. . . . . 0.846 0.960 . . . . . 0.960 . .



≥23.0/hr

NR Sleep clinic

patients

. . . . . 0.916 0.978 . . . . . 0.990 . .

* Abbreviations: +LR (positive likelihood ratio), -LR (negative likelihood ratio), AHI (apnea-hypopnea index), AUC (area under the curve), CABG (coronary artery bypass graft), CAD (coronary artery disease), COPD (chronic obstructive

pulmonary disease), CPAP (continuous positive airway pressure), FN (false negative), FP (false positive), N (number), NR (not reported), NPV (negative predictive value), MI (myocardial infarction), OSA (obstructive sleep apnea), OSAS (obstructive sleep apnea syndrome), PPV (positive predictive value), PSG (polysomnogram), RDI (respiratory disturbance index), Sen (sensitivity), Spec (specificity), TN (true negative), TP (true positive)


72

Table 14 - AHRQ Question 1a – Summary of Oximetry Diagnostic Studies (Oxygen Desaturation Index)

Study Search

Strategy

Sample Demographics N Index/Validation OSA Definition OSA Prevalence Oximetry

Cut-point(s)

PSG

Cut-Point(s)

Alvarez, 2012 Group 4 Sleep clinic patients with

high clinical

suspicion for OSA

Age: 52.3 ±13.7 years Male: 78%

BMI: 29.8 ±4.4 kg/m2

ESS: NR AHI: 25.7 ±26.1/hr

96 •Nonin Puresat pulse oximeter (≤3 sec averaging signal;

sampling rate 1 Hz)

• Type I Polysomnography



Hypopneas: ≥50% decrease in

nasal flow with either a >3% oxygen desaturation or an

EEG arousal

OSA: AHI ≥10/hr

OSA (AHI ≥10/hr): 67% (160/240)

No OSA (AHI <10): 33%

(80/240)

ODI (3%) ≥10/hr

AHI ≥10/hr

Chung, 2012 Group 3 Consecutive

preoperative

adults scheduled for

surgery.

Age: 60.3 ±12.7 years

Male: 54%

BMI: 30.5 ±6.8 kg/m2 ESS: NR

AHI: 9.1/hr (median, IQR 3.8-

21.4)

475 •PULSOX-300i pulse

oximeter wristwatch

(averaging time 3 seconds)


(Embletta X100)




>4% oxygen desaturation

OSA: AHI ≥5/hr


(171/475)

OSA (AHI ≥5): 64% (337/475) •Mild (AHI 5-15): 29%

(138)

•Moderate (AHI 15-30): 19% (92)


(74)

Various:

ODI (4%)

>5/hr ODI (4%)

>10/hr

ODI (4%) >15/hr

ODI (4%)

>30/hr

Various:

AHI >5/hr

AHI >15/hr AHI >30/hr

Ling, 2012 Group 3 Sleep disorder

clinic patients

referred for diagnostic

PSG

Age: 51.2 ±14.0 years

Male: 65%

BMI: 32.5 ±9.0 kg/m2 ESS: NR

AHI: 31.3 ±29.3/hr

11,448 •Integrated oximeter (Nonin

Xpod 3011, Nonin medical)


(Compumedics E-series)

AHI: “Respiratory events

were scored using Chicago

criteria” Hypopneas: ≥50% decrease



an arousal

OSA: AHI ≥5/hr

No OSA (AHI <15): 36%

(4121/11448)

OSA (AHI ≥15): 64% (7327/11448)

Various:

ODI (2%)

≥10/hr ODI (2%)

≥15/hr

ODI (2%)

≥20/hr

ODI (3%)

≥10/hr ODI (3%)

≥15/hr

ODI (3%) ≥20/hr

ODI (4%)

≥10/hr ODI (4%)

≥15/hr

ODI (4%) ≥20/hr

Various:

AHI ≥15/hr

AHI ≥30/hr

Morillo, 2012 Group 3 Sleep disorder

clinic patients with suspected

OSA

Age: 58.3 ±12.5 years

Male: 74% BMI: 32.1 ±6.3 kg/m2

ESS: NR

AHI: 28.9 ±28.3/hr

78 •Jaeger 70750A19 oximeter

(8 cycles per second)


(Erich Jaeger)




oxygen OSA: AHI ≥5/hr

No OSA (AHI <5): NR

OSA (AHI ≥5): NR

Various:

ODI (4%) ≥9/hr

ODI (4%)

≥12/hr ODI (4%)

Various:


AHI ≥15/hr

AHI ≥20/hr


73

•Chose optimal threshold

cut-point for ODI to comparison with PSG AHI

≥13/hr

ODI (4%) ≥19/hr

Nigro, 2012 Group 4 Sleep disorder

clinic patients with suspected

OSA

Age: 53.7 ±15.4 years

Male: 77% BMI: 27.5 kg/m2 (median, IQR

24.7-31.2)

ESS: NR AHI: 21.3/hr (median, IQR

8.8-43.5)

RDI: 24/hr (median, IQR 11.5-45.3)

119 •Oximetry (Nonin)

• Type I Polysomnography

(Neurotrace or MiniPC)

AHI: NR


hour of sleep

Hypopneas: NR; “in agreement with international

criteria”

RERA: NR OSA: RDI ≥5/hr


(17/119) OSA (RDI ≥5): 86%

(102/119)

Various:

ODI (3%) ≥15/hr OR

ODI (3%)

≥5/hr and ESS ≥12 or

comorbidity

ODI (4%)

≥15/hr OR

ODI (4%)

≥5/hr and ESS

≥12 or

comorbidity

RDI ≥15/hr

OR RDI ≥5/hr and

ESS ≥12 or

comorbidity (HTN,

cardiac

arrhythmias, CAD,

CVD, DM)

Sommerymeyer,

2012

Group 4 Sleep disorder

clinic patients

with suspected SDB

Age: 54.0 ±14.0 years

Male: 63%

BMI: 28.5 ±5.9 kg/m2 ESS: 10.0 ±5.0

AHI: 19.3 ±18.5/hr

66 • Oximetry – ODI

automatically scored by either

≥4% SO2 drop or ≥3% SpO2 drop with an autonomic

arousal (pulse rate ≥20%

from baseline or pulse wave amplitude (PWA) attenuation

≥40% from baseline or PWA

attenuation ≥35% with pulse rate increase ≥15% from

baseline.

• Type III Sleep Study

(SOMNOcheck2)




oxygen

OSA: AHI ≥5/hr


(23/66)

OSA (AHI ≥5): 65% (43/66) •Mild (AHI 5-15): 33%

(14/43)

•Moderate (AHI 15-30): 33% (14/43)


(15/43)

ODI (3% &

4%) ≥15/hr

AHI ≥15/hr

Ward, 2012 Group 3 Adult patients with low or

preserved

ejection fraction heart

failure

Age: 69.8 years (median, IQR 58.8-76.8)

Male: 86%

BMI: 29.1 kg/m2 (median, IQR 25.4-32.7)

ESS: NR

AHI: NR; for SDB 27.0 (median)

171 •Wrist worn pulse oximeter (Pulsox 3i, Konica Minolta,

sampling time 5s & data

storage frequency 0.2 Hz)


(SOMNOscreen, SOMNOmedics)



in nasal flow with either a ≥3% oxygen or EEG arousal

OSA: AHI ≥15/hr

•reported data separately for

with and without very low

frequency increment of heart

rate variability

No OSA (AHI <15): 56% (96/171)

OSA (AHI ≥15): 45%

(77/171)

Various: ODI (3%)

≥7.5/hr

ODI (3%) ≥12.5/hr

AHI ≥15/hr

Bohning, 2011 Group 4 Consecutive

sleep clinic patients

Age: 55 ±13 years

Male: 82% BMI:31.6 ±5.9 kg/m2

ESS: NR

135 •Oximetry (Nonin model

3100 WristOx): ODI (undefined)

AHI: NR



(18/135) OSA (AHI ≥5): 87%

(117/135)

Various:

ODI ≥5/hr ODI ≥15/hr

Various:



74

AHI: NR •Type I Polysomnography •Mild (AHI 5-15): 34%

(40/117) •Moderate (AHI 15-30):

21% (25/117)

•Severe (AHI ≥30): 44% (52/117)

Chai-Coetzer,

2011

Group 3 Adult

patients attending six

primary care

clinics


Male:53% BMI: 31.7 kg/m2 (range 28.8-

36.1)

ESS: 8 (range 4-10) AHI: 20.9/hr (range 13.1-41.3)

77 • Oximetry recorded from

ApneaLink device


AHI: NR

Hypopneas: Either ≥50% decrease in nasal flow or a


an EEG arousal OSA: AHI ≥30/hr

No OSA (AHI <30): 79%

(62/78) OSA (AHI ≥30): 21% (16/78)

•Mild: NR

•Moderate: NR •Mild: NR


Alvarez, 2010 Group 3 Symptomatic

patients with suspected

OSA

Age: 52.9 ±14.1 years

Male: 78% BMI: 29.8 ±5.6 kg/m2

ESS: NR

AHI: 29.0 ±28.5/hr

148 • Oximetry derived from PSG

(sampling rate 1 Hz)



AHI: “sum of apneas and




OSA: AHI ≥10/hr


(48/148) OSA (AHI ≥10/hr): 68%

(100/148)

Various:

ODI(2%) ≥10/hr

ODI(3%)

≥10/hr ODI(4%)

≥10/hr

AHI ≥10/hr

* Abbreviations: AHI (apnea-hypopnea index), BMI (body mass index), CABG (coronary artery bypass graft), CAD (coronary artery disease), COPD (chronic obstructive pulmonary disease), CPAP (continuous positive

airway pressure), DM (diabetes mellitus), EEG (electroencephalogram), ESS (Epworth sleepiness scale), hr (hour), IQR (interquartile range), MI (myocardial infarction), N (number), NR (not reported), OSA (obstructive sleep

apnea), OSAS (obstructive sleep apnea syndrome), mod (moderate), PSG (polysomnogram), RDI (respiratory disturbance index), RERA (respiratory effort related arousal), SDB (sleep disordered breathing)


75

Table 15 - AHRQ Question 1a – Diagnostic Accuracy of Oximetry Diagnostic Studies (Oxygen Desaturation Index)


Prevalence

Population TP FN FP TN p-

value

Sens Spec PPV NPV +LR -LR Accuracy AUC Pos

Posttest

Probability

Neg

Posttest

Probability

Alvarez, 2012 96 •PSG: AHI ≥10/hr

•Oximetry: ODI(3%) ≥10/hr


with suspected OSA

57 7 4 28 <0.001 0.891 0.875 0.934 0.800 7.125 0.125 0.885 NR 0.934 0.200

Chung, 2012 475 •PSG: AHI ≥5/hr


0.640 Preoperative patients 293 11 56 115 <0.001 0.964 0.673 0.840 0.913 2.943 0.054 0.859 0.908 0.840 0.087



0.349 Preoperative patients 165 1 190 119 <0.001 0.994 0.385 0.465 0.992 1.617 0.016 0.598 NR 0.465 0.008






















Ling, 2012 11,448 •PSG: AHI ≥15/hr


0.640 Sleep clinic patients 4521 2806 346 3775 <0.001 0.617 0.916 0.929 0.574 7.349 0.418 0.725 NR 0.929 0.426

11,448 •PSG: AHI ≥30/hr



11,448 •PSG: AHI ≥15/hr



11,448 •PSG: AHI ≥30/hr



Morillo, 2012 78 •PSG: AHI ≥5/hr

•Oximetry: ODI (4%) ≥9/hr


with suspected OSA

. . . . . 0.832 0.790 . . 2.97 0.19 . 0.910 . .




with suspected OSA

. . . . . 0.872 0.805 . . 4.47 0.16 . 0.910 . .




with suspected OSA

. . . . . 0.923 0.769 . . 3.43 0.11 . 0.910 . .




with suspected OSA

. . . . . 0.848 0.828 . . 4.92 0.18 . 0.930 . .

Nigro, 2012 119 •PSG: RDI ≥15/hr OR RDI ≥5/hr and

ESS ≥12 or comorbidity

•Oximetry ODI (3%) ≥15/hr OR ODI

(3%) ≥5/hr and ESS ≥12 or

comorbidity


with suspected OSA

88 7 2 22 <0.001 0.926 0.917 0.978 0.759 11.12 0.080 0.924 0.923 0.978 0.241

119 •PSG: RDI ≥15/hr OR RDI ≥5/hr and

ESS ≥12 or comorbidity

•Oximetry: ODI (4%) ≥15/hr OR

ODI (4%) ≥5/hr and ESS ≥12 or

comorbidity


with suspected OSA

75 19 1 24 <0.001 0.798 0.960 0.987 0.558 19.95 0.211 0.832 0.879 0.987 0.442


76

Sommerymeyer,

2012


•Oximetry: ODI (3% and 4%) ≥15/hr


with suspected SDB

28 1 2 35 <0.001 0.966 0.946 0.933 0.972 17.86 0.036 0.955 0.980 0.933 0.028

Ward, 2012 171 •PSG: AHI ≥15/hr

•Oximetry: ODI(3%) ≥7.5/hr

0.444 CHF patients 74 2 65 30 <0.001 0.974 0.316 0.532 0.938 1.423 0.083 0.608 0.920 0.532 0.062


•Oximetry: ODI(3%) ≥12.5/hr

0.444 CHF patients 71 5 26 69 <0.001 0.934 0.726 0.732 0.932 3.413 0.091 0.819 NR 0.732 0.068

Bohning, 2011 134 •PSG: AHI ≥5/hr

•Oximetry: ODI (undefined) ≥5/hr


with suspected OSA

117 0 11 6 <0.001 1.000 0.353 0.914 1.000 1.545 0.000 0.918 NR 0.914 0.000


•Oximetry: ODI (undefined) ≥15/hr


with suspected OSA

51 26 1 56 <0.001 0.662 0.982 0.981 0.683 37.75 0.344 0.799 NR 0.981 0.317

Chai-Coetzer,

2011



0.210 Primary care clinic

patients

. . . . . . . . . . . . 0.960 . .




with suspected OSA

85 15 6 42 <0.001 0.850 0.875 0.934 0.737 6.80 0.171 0.858 0.943 0.934 0.263




with suspected OSA

86 14 7 41 <0.001 0.860 0.854 0.925 0.745 5.90 0.164 0.858 0.932 0.925 0.255




with suspected OSA

85 15 6 42 <0.001 0.850 0.875 0.934 0.737 6.80 0.171 0.858 0.922 0.934 0.263

* Abbreviations: +LR (positive likelihood ratio), -LR (negative likelihood ratio), AHI (apnea-hypopnea index), AUC (area under the curve), CPAP (continuous positive airway pressure), FN (false negative), FP (false positive), N

(number), NR (not reported), NPV (negative predictive value), ODI (oxygen desaturation index), OSA (obstructive sleep apnea), PPV (positive predictive value), PSG (polysomnogram), RDI (respiratory disturbance index), Sen (sensitivity), Spec (specificity), TN (true negative), TP (true positive)


77

Table 16 – Summary of Oximetry Diagnostic Studies (Other than Oxygen Desaturation Index)

Study Search

Strategy

Sample Demographics N Index/Validation OSA Definition OSA Prevalence Oximetry

Cut-point(s)

PSG

Cut-Point(s)

Alvarez,

2012

Group 4 Sleep clinic patients with

high clinical

suspicion for OSA

Age: 52.3 ±13.7 years

Male: 78%

BMI: 29.8 ±4.4 kg/m2

ESS: NR

AHI: 25.7 ±26.1/hr

144 •Nonin Puresat pulse oximeter (≤3 sec averaging signal; sampling rate 1 Hz)

• Type I Polysomnography (Alice 5, Respironics) •16 features (time and frequency statistics and

spectral and nonlinear features) were computed

using a genetic algorithm. Optimal model contained 6 variables: time domain statistics (M1t,

M3t, M4T), frequency domain statistics (MF),

conventional spectral measures (PA) and nonlinear

measures (CTM).

AHI: sum of apneas and hypopneas per hour of

sleep

Hypopneas: ≥50% decrease in nasal flow

with either a >3% oxygen


OSA: AHI ≥10/hr

No OSA (AHI <10): 33% (80/240)

OSA (AHI ≥10/hr): 67%

(160/240)

NR

AHI ≥10/hr

Marcos,

2012

Group 3 Symptomatic

patients (sleepiness,

snoring,

witnessed apneas)

suspected of

sleep apnea. Initial

population

randomly divided into

training and

test sets.

Age: 52.2 ±13.7

years Male: 78%

BMI: 29.8 ±4.5

kg/m2 ESS: NR

AHI: 26.4

±26.7/hr

144 •Nonin Puresat pulse oximeter (averaging time 3

seconds)

•Type I Polysomnography (Alice 5, Respironics,

Philips Healthcare) •Multiple linear regression and multilayer

perceptron neural networks evaluated oximetry

data ( time-domain, frequency-domain parameters) to derive oximetry algorithm predictive of OSA

AHI: “Per rules proposed

by Rechtschaffen and Kales”

Hypopneas: NR

OSA: AHI ≥5/hr


(115/144) OSA AHI ≥5):: 20%

(29/144)

•Mild (AHI 5-15): 30% (35/115)


26% (30/115) •Severe (AHI ≥30): 43%

(50/115)

Various:


AHI ≥15/hr

AHI ≥30/hr

Various:


AHI ≥15/hr

AHI ≥30/hr

Morillo,

2012

Group 3 Sleep disorder

clinic patients

with suspected OSA

Age: 58.3 ±12.5

years

Male: 74% BMI: 32.1 ±6.3

kg/m2

ESS: NR AHI: 28.9

±28.3/hr

78 •Jaeger 70750A19 oximeter (8 cycles per second)

•Type I Polysomnography (Erich Jaeger) •An alternative frequency desaturation index

(FDI) was obtained by regression analysis

•Chose optimal threshold cut-point for FDI to comparison with PSG AHI



sleep Hypopneas: ≥50%


with either a ≥4% oxygen OSA: AHI ≥5/hr

No OSA (AHI <5): NR

OSA (AHI ≥5): NR

Various:

FDI ≥7.45/hr

FDI ≥15.5/hr FDI ≥19.1/hr

FDI ≥22.0/hr

Various:

AHI ≥5/hr


AHI ≥20/hr

Batchelder,

2011

Group 3 Consecutive patients

referred for

suspected SDB


Male:

BMI:36.0 ±9.6 kg/m2

ESS: NR AHI: NR

104 •Nellcor OxiMax Max-A digit sensor and Nellcor N-600x pulse oximeter (Covidien)

•Type III sleep study (in-lab study; although additional PSG channels were captured; only

airflow, oximetry and respiratory inductance plethysmography were evaluated).

•Pulse oximetry saturation patterns recognition

AHI: NR Hypopneas: ≥40%


with a ≥3% oxygen desaturation

OSA: AHI ≥5/hr

No OSA: NR OSA: NR

NA (unit of analysis

was respiratory

event – not patient; various threshold

were High, Medium and Low

saturation pattern

detection)

NA (unit of

analysis

was respiratory

event – not patient;

various

threshold


78

algorithm (OxiMax SPD) designed to detect

specific signatures of SpO2 trend associated with repetitive reductions in airflow (RRiA)

were High,

Medium and Low

saturation

pattern detection)

Marcos,

2011

Group 3 Patients

suspected of OSA

Age: 52.4 ±13.8

years Male: 77%

BMI: 29.8 ±4.2

kg/m2 ESS: NR

AHI: 24.8

±25.2/hr

96 • Nonin PurseSat pulse oximeter (sampling

frequency of 1 Hz)

•Type I Polysomnography (Alice 5, Respironics)

•KerEnt analysis (nonlinear measure) of SpO2

signals to evaluate degree of irregularity to predict

AHI

AHI: “According to the

rules proposed by Rechtschaffen and Kales”

Hypopneas: NR

OSA: AHI ≥10/hr


(32/96) OSA (AHI ≥10/hr): 67%

(64/96)

Oximetry KerEnt

Analysis: -0.02 threshold

AHI ≥10/hr

Alvarez,

2010

Group 3 Symptomatic patients with

suspected

OSA


Male: 78%

BMI: 29.8 ±5.6 kg/m2

ESS: NR

AHI: 29.0 ±28.5/hr

148 • Oximetry derived from PSG (sampling rate 1 Hz)

•Type I Polysomnogram (Alice 5, Respironics)

•Relationship between changes in airflow and

SpO2 (particularly peak amplitude and relative

power in the very low frequency band) were analyzed via magnitude squared coherence

function to predict AHI

•Logistic regression was performed on common

oximetry statistics in the time and frequency domains, conventional spectral characteristics from

the power spectral density function and nonlinear

features. Variables assessed in model: relative

power (PR), fourth order statistical moments in the

time domain (M4t), Lempel-Ziv complexity (LZC),

second order statistical moments in the time domain(M2t)

AHI: “sum of apneas and hypopneas per hour of

sleep

Hypopneas: ≥50% decrease in airflow and

either ≥3% oxygen


OSA: AHI ≥10/hr

No OSA (AHI <10/hr): 32% (48/148)

OSA (AHI ≥10/hr): 68%

(100/148)

Peak amplitude (PA), and Relative

Power (PR)

assessed for SpO2, flow and

magnitude squared

coherence; relative power (PR), fourth

order statistical

moments in the time domain (M4t),

Lempel-Ziv complexity (LZC),

second order

statistical moments

in the time

domain(M2t)

AHI ≥10/hr





79

Table 17 – Diagnostic Accuracy of Oximetry Diagnostic Studies (Other than Oxygen Desaturation Index)


Prevalence

Population TP FN FP TN p-value Sens Spec PPV NPV +LR -LR Accuracy AUC Pos Posttest

Probability

Neg Posttest

Probability

Alvarez, 2012 144 •PSG: AHI≥10/hr •6 Variable Oximetry

Model

0.667 Sleep clinic patients with

suspected OSA

87 9 9 39 <0.001 0.906 0.813 0.906 0.813 4.833 0.115 0.875 NR 0.906 0.188

Marcos, 2012 144 •PSG: AHI≥5/hr •Oximetry MLP:

≥5/hr

0.799 Symptomatic patients with

suspected OSA

101 14 9 20 <0.001 0.878 0.690 0.918 0.588 2.83 0.177 0.840 NR 0.918 0.412

144 •PSG: AHI≥15/hr

•Oximetry MLP: ≥15/hr

0.556 Symptomatic


74 6 4 60 <0.001 0.925 0.938 0.949 0.909 14.80 0.080 0.931 NR 0.949 0.091

144 •PSG: AHI≥30hr

•Oximetry MLP: ≥30/hr

0.427 Symptomatic


45 5 3 64 <0.001 0.900 0.955 0.938 0.928 20.10 0.105 0.932 NR 0.938 0.072

Morillo, 2012 78 •PSG: AHI ≥5/hr

•Oximetry: FDI ≥7.5/hr

NR Sleep clinic


. . . . . 0.900 0.750 0.930 0.595 3.60 0.130 . 0.890 . .


•Oximetry: FDI ≥15.5/hr

NR Sleep clinic


. . . . . 0.833 0.804 0.890 0.720 4.27 0.210 . 0.900 . .


•Oximetry: FDI

≥19.1/hr

NR Sleep clinic

patients with

suspected OSA

. . . . . 0.846 0.769 0.810 0.800 3.67 0.200 . 0.910 . .


•Oximetry: FDI

≥22/hr

NR Sleep clinic

patients with

suspected OSA

. . . . . 0.864 0.828 0.860 0.820 5.01 0.160 . 0.920 . .

Batchelder,

2011

104 “High” SPD

assessment setting

NR Sleep clinic

patients with

suspected OSA

498 123 384 2912 . 0.802 0.883 . . . . 0.871 0.870 . .

104 “Medium” SPD assessment setting

NR Sleep clinic patients with

suspected OSA

202 419 113 3183 . 0.325 0.966 . . . . 0.966 0.870 . .

104 “Low” SPD assessment setting

NR Sleep clinic patients with

suspected OSA

63 558 11 3285 . 0.101 0.997 . . . . 0.855 0.870 . .

Marcos, 2011 96 •PSG: AHI ≥10/hr

•Oximetry KerEnt

Analysis: --0.02

threshold

0.667 Symptomatic

patients with

suspected OSA

52 12 6 26 <0.001 0.813 0.813 0.897 0.684 4.33 0.231 0.813 0.870 0.897 0.316


•Oximetry: PASPO2

0.676 Symptomatic

patients with

84 16 8 40 <0.001 0.840 0.833 0.913 0.714 5.040 0.192 0.838 0.901 0.913 0.286


80

suspected OSA


•Oximetry: PSPO2

0.676 Symptomatic


84 16 9 39 <0.001 0.840 0.813 0.903 0.709 4.480 0.197 0.831 0.996 0.903 0.291


•Oximetry: LR (PR, M4t, LZC, M2t)

0.676 Symptomatic


92 8 7 41 <0.001 0.920 0.854 0.929 0.837 6.309 0.094 0.899 0.967 0.929 0.163


obstructive pulmonary disease), CPAP (continuous positive airway pressure), FN (false negative), FP (false positive), N (number), NR (not reported), NPV (negative predictive value), MI (myocardial infarction), ODI (oxygen desaturation index), OSA (obstructive sleep apnea), OSAS (obstructive sleep apnea syndrome), PPV (positive predictive value), PSG (polysomnogram), RDI (respiratory disturbance index), Sen (sensitivity), Spec (specificity), TN (true

negative), TP (true positive)


81

Table 18 - AHRQ Question 1b – Summary of Berlin Questionnaire (BQ) Diagnostic Studies

Study Search

Strategy

Sample Demographics N Validation OSA Definition OSA Prevalence Berlin

Cut-point(s)

AHI

Cut-Point(s)

Geiger-Brown,

2013

Group 3 Chronically partially

sleep-deprived shift-work nurses.

Age: 40 ±13 years

Male: 0% BMI: NR

ESS: NR

AHI: 2.3 ±5.4/hr

21 Type I

Polysomnography

RDI: sum of apneas,





>4% oxygen desaturation RERA’s: 30 to 90%


OSA: AHI ≥5/hr

SDB (RDI ≥5): 43% (9/21) - 24%

mild, 19% moderate, 0% severe

No OSA (AHI<5): 86% (17/21)

OSA (AHI ≥5): 14% (3/21) •Mild (AHI 5-15): 100% (21/21)

•Moderate (AHI 15-30): 0%


BQ ≥2 Various:

AHI ≥5/hr RDI ≥5/hr

Danzi-Soares,

2012

Group 3 Consecutive patients referred for CABG


BMI: 27.6 ±27.6 kg/m2

ESS: 7 (range 5-11) AHI: 22.9 ±20.0/hr

70 Type I Polysomnography




OSA: AHI ≥5/hr

No OSA (AHI <5): 12.9% (9/70) OSA (AHI ≥5): 87.1% (61/70)

•Mild (AHI 5-15): 32.9% (23/70)

•Moderate (AHI 15-30): 27.1% (19/70)

•Severe (AHI ≥30): 27.1% (19/70)

BQ ≥2 Various: AHI ≥5/hr

AHI ≥15/hr

Facco, 2012 Group 3 Pregnant women at high risk for sleep apnea

(hypertension,

pregestational diabetes, BMI ≥30, prior

preeclampsia)


BMI: 31.9 ±9.1 kg/m2

ESS: 7.5 ±4.3 (0-19) AHI: 1.5/hr (median, IQR

0.6-6.0)

100 Type IV Sleep Study (Watch-

PAT100, Itamar

Medical)

AHI: “analysis of the WP100 signals allows for

the determination of the

AHI” Hypopneas: Not defined

OSA: AHI ≥5/hr

No OSA (AHI<5): 72% (72/100) OSA (AHI ≥5): 28% (28/100)

•Mild: NR

•Moderate: NR •Severe: NR

BQ ≥2 AHI ≥5/hr

Gjevre, 2012 Group 3 Rheumatoid arthritis patients with and

without abnormal scores

on the ESS and/or Pittsburgh Sleep Quality

Index


BMI: 29.7 ±4.2 kg/m2

ESS: NR AHI: 14.7 ±14.8/hr


(15 channel,

Sandman software)


Hypopneas: Not defined

OSA: AHI ≥5/hr

No OSA (AHI<5): 32% (8/25) OSA (AHI ≥5): 68% (17/25)

•Mild: NR


BQ ≥2 AHI ≥5/hr

Koyama, 2012 Group 3 Male railroad workers Age: 35.6 ±9.6 years Male: 100%

BMI: 26.7 ±4.1 kg/m2

ESS: 7.9 ±3.6 AHI: NR


(EMBLA Titanium)


OSAS: AHI ≥15/hr or (AHI

≥5/hr and ESS ≥10)

No OSAS: 65% (484/745) OSAS: 35% (261/745)

•Mild: 54%

•Moderate: 25% •Severe: 20%

BQ ≥2 AHI ≥15/hr or (AHI

≥5/hr and

ESS ≥10)

Laporta, 2012 Group 4 Veterans with ischemic

heart disease

Age: 67.7 ±11.8 years

Male: 100% BMI: 29.9 ±5.0 kg/m2

ESS: 9.3 ±4.8

AHI: 19.9 ±19.0/hr

91 Type I

Polysomnography


hypopneas per hour of sleep Hypopneas: ≥50 decrease in

nasal flow with a >3%

oxygen OSA: AHI ≥5/hr

No OSA (AHI <5): 25% (22/91)

OSA (AHI ≥5): 75% (69/91) •Mild (AHI 5-15): 41% (28/69)


(19/69) •Severe (AHI ≥30): 31% (21/69)

BQ ≥2 Various:



82

Martinez, 2012 Group 3 Consecutive patients

with prior angina (age <65, BMI ≤40, no

COPD or DM,

nonsmoker, prior CAD intervention, recent

angina)

Age: 54 ±6.9 years

Male: 46% BMI: 23 ±11 kg/m2

ESS: NR

AHI: 17 ±14/hr

57 Type III Home

Sleep Study (SOMNOcheck)





No OSA (AHI<5): 21% (12/57)

OSA (AHI ≥5): 79% (45/57) •Moderate-severe (AHI ≥15): 55%

(25/45)

BQ ≥2 AHI ≥15/hr

Enciso, 2011 Group 4 Patients of the USC School of Dentistry

Age: 54.9 ±12.1 years Male: 77%

BMI: 26.6 ±18.1 kg/m2

ESS: NR RDI: 24.3 ±18.1/hr

84 Type IV Home Sleep Study (ARES

Unicorder)


OSA: RDI ≥15/hr

No OSA (RDI<15): 37% (31/84) OSA (RDI ≥15): 63% (53/84)

BQ ≥2 Various: RDI ≥10/hr

RDI ≥15/hr

Hrubos-Strom,

2011

Group 3 Norwegian general

population

Age: 48.3 ±11.2 years

Male: 54.8% BMI: 27.9 ±4.8 kg/m2

ESS: 8.8 ±4.6


518 Type I

Polysomnography



in nasal flow with a >4%


No OSA (AHI <5): 84% (435/518)

OSA (AHI ≥5): 16% (83/518) •Mild (AHI 5-15): 51% (42/83)

•Moderate-Severe (AHI ≥15): 49%

(41/83))

BQ ≥2 Various:


Sert

Kuniyoshi,

2011

Group 3 Cross-sectional study of

recent MI patients (1 to 3 months prior).

Excluded patients with prior OSA diagnosis

receiving CPAP

treatment.

Age: 62 ±13years

Male: 81% BMI: 30 ±5 kg/m2

ESS: 9.1 ±4.2 AHI: NR

99 Type I

Polysomnography (Compumedics)



decrease in nasal flow with a ≥4% oxygen desaturation

OSA: AHI ≥5/hr

No OSA (AHI<5): 26% (26/99)

OSA (AHI ≥5): 74% (73/99) •Mild (AHI 5-15): 37% (27/73)

•Moderate (AHI 15-20): 34% (25/73)

•Severe (AHI ≥30): 29% (21/73)

BQ ≥2 Various:


AHI ≥30/hr

Sforza, 2011 Both:

Group 3

Group 4

Prospective study of

participants age ≥65

from the PROOF study (French population)


Male: 40.9%

BMI: 25.3 ±5.1 kg/m2 ESS: 5.6 ±5.1

AHI: 21.6 ±16.0/hr

643 Type III Home

Sleep Study

(HypnoPTT, Tyco Healthcare, Puritan

Bennett Co, USA)




oxygen desaturation

OSA: AHI ≥15/hr

•Provided data/outcomes

separately by gender and Mini-Mental-State

Examination

No OSA (AHI<15): 43% (274/643)

OSA: (AHI ≥15): 57% (369/643)

BQ ≥2 Various:

AHI ≥15/hr

AHI ≥30/hr

Subramanian,

2011

Group 3 Consecutive patients referred for suspected

sleep apnea (no prior

OSA Diagnosis)


BMI: 35 ±9 kg/m2

ESS: NR RDI: 38 ±8/hr

509 •Type I Polysomnography


hour of sleep

Hypopneas: required ≥4% oxygen desaturation in

addition to defined reduction

in airflow per 2007 American Academy of Sleep

No OSA (RDI<5): 15% (77/509) OSA: (RDI ≥5): 85% (432/509)

•Mild: 31% (134/432)

•Moderate/Severe (RDI ≥15): 69% (298/432)

BQ ≥2 Various: RDI ≥5/hr

RDI ≥15/hr


83

Medicine Scoring

Guidelines RERA’s: NR

OSA: RDI ≥5

Thurtell, 2011 Group 3 Newly diagnosed idiopathic intracranial

hypertension

Age: 32 years (median, range 16-54)

Male: 20%

BMI: 39.8 kg/m2 (median, range 27-52)

ESS: NR

AHI: NR



Hypopneas: “determined

using conventional criteria.” Reference to 2007 AASM

scoring criteria.

OSA: AHI ≥5/hr

No OSA (AHI<5): 40% (12/30) OSA (AHI ≥5): 60% (18/30)

•Mild (AHI 5-15): 39% (7/18)

•Moderate (AHI 15-20): 22% (4/18)

•Severe (AHI ≥30): 39% (7/18)

BQ ≥2 AHI ≥5/hr

Vaz, 2011 Group 4 Consecutive sleep clinic

patients referred for

suspected sleep apnea

•Also assessed a

“modified” Berlin Questionnaire (no

previously validated)

Age: 51 ±13 years

Male: 67%

BMI: NR (55% had BMI >30 kg/m2)

ESS:10 ±6

AHI: 24 ±17/hr

95 Type III Sleep

Study (alpha screen;

Vyasis)




≥4% oxygen desaturation.

OSA: AHI ≥5/hr

No OSA (AHI<5): 17% (16/95)

OSA (AHI ≥5): 83% (79/95)


(20/79)

•Severe (AHI ≥30): 33% (26/79)

BQ ≥2 Various:

AHI ≥5/hr


Patt, 2010 Group 4 Patients with chronic wounds

Age: 55±16.1 years Male: 48%

BMI: 32 ±16.1 kg/m2

ESS: 8.9 ±4.8 AHI: 15.6/hr

46 Type III Home Sleep Study

(Stardust II,

Respironics)



in nasal flow with a ≥4% oxygen

OSA: AHI ≥15/hr

No OSA (AHI<5): 17% (12/46) OSA (AHI ≥5): 83% (38/46)

•Mild (AHI 5-15): 32% (12/38)

•Moderate-Severe (AHI 15-30): 68% (26/38)

BQ ≥2 AHI ≥15/hr





84

Table 19 - AHRQ Question 1b – Diagnostic Accuracy of Berlin Questionnaire (BQ) Diagnostic Studies


Prevalence


Odds Ratio

p-

value


Probability

Neg

Posttest

Probability

Kappa(1)

Coefficient

Geiger-Brown,

2013

21 BQ ≥2

AHI ≥5/hr

0.143 Sleep

deprived shift

workers

2 1 15 3 0.40 <0.001 0.667 0.167 0.118 0.750 0.800 2.00 0.238 NR 0.118 0.250 -0.029

21 BQ ≥2

RDI ≥5/hr

0.429 Sleep

deprived shift

workers

3 6 2 10 0.375 0.333 0.833 0.600 0.625 2.00 0.800 0.619 NR 0.600 0.375

Danzi-Soares,

2012

70 BQ ≥2

AHI ≥5/hr

0.871 CABG 44 17 5 4 2.07 0.311 0.721 0.444 0.898 0.190 1.298 0.627 0.686 NR 0.898 0.810 0.206

70 BQ ≥2

AHI ≥15/hr

0.543 CABG 28 10 21 11 1.47 0.464 0.737 0.344 0.571 0.524 1.123 0.766 0.557 NR 0.571 0.476 0.063

Facco, 2012 100 BQ ≥2

AHI ≥5/hr

0.280 Pregnant

women

11 17 23 49 22.59 0.487 0.393 0.681 0.324 0.742 1.23 0.892 0.600 0.540 0.324 0.258 0.060

Gjevre, 2012 25 BQ ≥2

AHI ≥5/hr

0.680 Rheumatoid

arthritis

7 10 2 6 1.86 0.432 0.412 0.750 0.778 0.375 1.647 0.784 0.520 NR 0.778 0.625 0.306

Koyama, 2012 745 AHI ≥15/hr

or (AHI

≥5/hr and

ESS≥10

0.350 Male railroad

workers

103 158 387 97 <0.001 0.395 0.200 0.210 0.380 0.494 3.021 0.268 NR 0.210 0.620

Laporta, 2012 91 BQ ≥2

AHI ≥5/hr

0.747 Male veterans

with IHD

56 12 14 9 2.96 0.035 0.824 0.391 0.800 0.429 1.353 0.451 0.714 NR 0.800 0.571 0.209

Martinez, 2012 57 BQ ≥2

AHI ≥15/hr

0.439 Angina

patients

18 7 16 16 2.57 <0.001 0.720 0.500 0.529 0.696 1.440 0.560 0.596 NR 0.529 0.304 0.162

Enciso, 2011 84 BQ ≥2

RDI ≥10/hr

0.774 Dentistry

patients

44 21 6 13 0.005 0.677 0.684 0.880 0.382 2.144 0.472 0.679 NR 0.880 0.618

84 BQ ≥2

RDI ≥15/hr

0.631 Dentistry

patients

36 17 14 17 22.59 0.040 0.679 0.548 0.720 0.500 1.504 0.585 0.631 NR 0.720 0.500 0.241

Hrubos-Strom,

2011

518 BQ ≥2

AHI ≥5/hr

0.160 Norwegian

population

31 52 70 365 3.11 <0.001 0.373 0.839 0.307 0.875 2.321 0.747 0.764 NR 0.307 0.125 0.175

518 BQ ≥2

AHI ≥15/hr

0.079 Norwegian

population

18 23 97 380 3.07 <0.001 0.439 0.797 0.157 0.943 2.159 0.704 0.768 NR 0.157 0.057 0.084

Sert Kuniyoshi,

2011

99 BQ ≥2

AHI ≥5/hr

0.737 Recent MI 50 23 14 12 1.85 0.179 0.685 0.462 0.781 0.343 1.272 0.683 0.626 0.580 0.781 0.657 0.167

99 BQ ≥2

AHI ≥15/hr

0.465 Recent MI 30 16 34 19 1.04 0.912 0.652 0.358 0.469 0.543 1.017 0.970 0.495 0.500 0.469 0.457 0.008

99 BQ ≥2

AHI ≥30/hr

0.212 Recent MI 15 6 49 29 0.464 0.714 0.372 0.234 0.829 1.137 0.768 0.444 0.540 0.234 0.171

Sforza, 2011 643 BQ ≥2

AHI ≥15/hr

0.574 Age ≥65 283 86 166 108 2.14 <0.001 0.767 0.394 0.630 0.557 1.266 0.591 0.608 NR 0.630 0.443 0.132

643 BQ≥2

AHI ≥30/hr

NR Age ≥65 . . . . . 0.234 0.766 . . . . . . . .


85

Subramanian,

2011

509 BQ ≥2

RDI ≥5/hr

0.849 Suspected

OSA

397 35 63 14 2.56 0.006 0.919 0.182 0.863 0.286 1.123 0.446 0.807 NR 0.863 0.714 0.095

509 BQ ≥2

RDI ≥15/hr

0.585 Suspected

OSA

277 21 181 30 2.17 0.008 0.930 0.142 0.605 0.588 1.084 0.496 0.603 NR 0.605 0.412 0.047

Thurtell, 2011 30 BQ ≥2

AHI ≥5/hr

0.600 Intracranial

HTN

15 3 5 7 6.04 0.018 0.833 0.583 0.750 0.700 2.000 0.286 0.733 NR 0.750 0.300 0.375

Vaz, 2011 95 BQ ≥2

AHI ≥5/hr

0.832 Suspected

OSA

57 22 8 8 2.56 0.082 0.722 0.500 0.877 0.267 1.443 0.557 0.684 0.611 0.877 0.733 0.269

95 BQ ≥2

AHI ≥15/hr

0.484 Suspected

OSA

38 8 27 22 3.17 0.004 0.826 0.448 0.585 0.733 1.499 0.387 0.632 0.637 0.585 0.267 0.195

95 BQ≥2

AHI ≥30/hr

0.274 Suspected

OSA

23 3 58 37 <0.001 0.885 0.389 0.284 0.925 1.449 0.296 0.632 0.638 0.353 0.100

Patt, 2010 46 BQ ≥2

AHI ≥15/hr

0.565 Chronic

wounds

15 11 11 9 1.11 0.855 0.577 0.450 0.577 0.450 1.049 0.940 0.522 NR 0.577 0.550 0.027

* Abbreviations: +LR (positive likelihood ratio), -LR (negative likelihood ratio), AHI (apnea-hypopnea index), AUC (area under the curve), CABG (coronary artery bypass graft), CAD (coronary artery disease),

COPD (chronic obstructive pulmonary disease), CPAP (continuous positive airway pressure), FN (false negative), FP (false positive), N (number), NR (not reported), NPV (negative predictive value), MI (myocardial infarction), ODI (oxygen desaturation index), OSA (obstructive sleep apnea), OSAS (obstructive sleep apnea syndrome), PPV (positive predictive value), PSG (polysomnogram), RDI (respiratory

disturbance index), Sen (sensitivity), Spec (specificity), TN (true negative), TP (true positive)


86

Table 20 - AHRQ Question 1b – Summary of Epworth Sleepiness Scale (ESS) Diagnostic Studies

Study Search

Strategy

Sample Demographics N Validation OSA Definition OSA Prevalence ESS

Cut-point(s)

AHI

Cut-Point(s)

Sharkey, 2013 Group 4 Patients evaluated for bariatric surgery


BMI: 50.2 ±7.7 kg/m2

ESS: 6.3 ±4.8 AHI: 29.5 ±31.5/hr




nasal flow with a >3% oxygen desaturation

OSA: AHI ≥15/hr

No OSA (AHI <15): 42% (112/269) OSA (AHI ≥15): 58% (157/269)


(77/157) •Severe (AHI ≥30): 51% (80/157)

Various: ESS ≥10

ESS ≥16


AHI ≥30/hr

Vana, 2013 Group 4 New adult patients referred to clinic for

sleep evaluations

Age: 46.4 ±13.2 years Male: 34%

BMI: 36.3 ±9.2 kg/m2

ESS: 8.0 (median, range 0-24)

AHI: 8.9/hr (median,

range 0 -99.9)


(diagnostic or split-

night protocols)



nasal flow with a ≥4% oxygen desaturation

OSA: AHI ≥5/hr

No OSA (AHI <5): 32% (15/47) OSA (AHI ≥5): 68% (32/47)

•Mild (AHI 5-15): 48% (15/47)

•Moderate (AHI 15-30): 25% (8/47)

•Severe (AHI ≥30): 28% (9/47)

ESS >10

AHI ≥5/hr

Albuquerque,

2012

Group 4 Afib patients

referred for direct

current cardioversion


Male: 76%

BMI: 34.1 ±8.6 kg/m2 ESS: 8.9 ±4.4

AHI: 23.1 ±22.6/hr

151 Type I

Polysomnography

(Nicolet Instrument Corp)

AHI: sum of apneas and hypopneas

per hour of sleep

Hypopneas: 50 to 90% decrease in nasal flow with a ≥4% oxygen

OSA: AHI ≥5/hr (obstructive

events) SDB: AHI ≥5/hr (obstructive,

central or mixed events)

No SDB (AHI <5): 22% (33/151)

SDB (AHI ≥5): 78% (118/151)


(35/118)

•Severe (AHI ≥30): 37% (44/118)

(Pure OSA: 57%, Pure CSA: 10.6%,

Mixed sleep apnea: 18.6%)

Various:

ESS >10

ESS ≥10

Various:

AHI ≥5/hr


Asha’ari, 2012 Group 4 Hypertensive (case)

and non-

hypertensive (control) groups


Male: 72%

BMI: 30.8 ±7.5 kg/m2 ESS: NR (32% ESS ≥10)

AHI: 25.9 ±4.5/hour

240 Type I

Polysomnography

AHI: not reported

Hypopneas: “according to the

AASM 2007 guidelines” OSA: AHI ≥5/hr

No OSA (AHI <5): 33% (78/240)

OSA (AHI ≥5): 68% (162/240)

•Mild (AHI 5-15): NR •Moderate (AHI 15-30): NR

•Severe (AHI ≥30): NR

Various:

ESS ≥10

ESS ≥14

AHI ≥5/hr

Danzi-Soares,

2012

Group 3 Consecutive patients referred for

CABG


BMI: 27.6 ±27.6 kg/m2

ESS: 7 (range 5-11) AHI: 22.9 ±20.0/hr



Hypopneas: 50 to 90% decrease in

nasal flow with a >3% oxygen desaturation

OSA: AHI ≥5/hr

No OSA (AHI <5): 12.9% (9/70) OSA (AHI ≥5): 87.1% (61/70)

•Mild (AHI 5-15): 32.9% (23/70)

•Moderate (AHI 15-30): 27.1% (19/70)

•Severe (AHI ≥30): 27.1% (19/70)

ESS >10


AHI ≥15/hr

Facco, 2012 Group 3 Pregnant women at high risk for sleep

apnea

(hypertension, pregestational

diabetes, BMI ≥30,


BMI: 31.9 ±9.1 kg/m2

ESS: 7.5 ±4.3 (0-19) AHI: 1.5/hr (median. IQR

0.6-6.0)

100 Type IV Sleep Study (Watch-

PAT100, Itamar

Medical)

AHI: “analysis of the WP100 signals allows for the determination

of the AHI”


No OSA (AHI<5): 72% (72/100) OSA (AHI ≥5): 28% (28/100)

•Mild: NR


Various: ESS ≥10

ESS ≥12

AHI ≥5/hr


87

prior preeclampsia)

Feng, 2012 Group 4 Consecutive patients referred to

a sleep center for

suspected OSA

Age: 45.9 ±12.1 years Male: 86%

BMI: 27.6 ±3.9 kg/m2

ESS: 9.4 ±5.0 AHI: 35.2 ±25.2/hr

2,297 Type I Polysomnography



nasal flow with either a >3% oxygen desaturation or signs of a

physiologic arousal

OSA: AHI ≥5/hr

No OSA (AHI<5): 9% (213/2297) OSA (AHI ≥5): 91% (2084/2297)

•Mild: 20% (420/2297)

•Moderate: 22% (460/2297) •Severe: 58% (1204/2084)

ESS >10


AHI ≥15/hr

AHI ≥30/hr

Gjevre, 2012 Group 3 Rheumatoid

arthritis patients

with and without abnormal scores on

the ESS and/or

Pittsburgh Sleep Quality Index


Male: 28%

BMI: 29.7 ±4.2 kg/m2 ESS: NR

AHI: 14.7 ±14.8/hr

25 Type I

Polysomnography

(15 channel, Sandman software)


per hour of sleep


No OSA (AHI<5): 32% (8/25)

OSA (AHI ≥5): 68% (17/25)

•Mild: NR •Moderate: NR

•Severe: NR

ESS >10 AHI ≥5/hr

Knutson, 2012 Group 3 Obese (BMI 30-55)

men and premenopausal

women aged 18-50

years reporting less than 6.5 hrs of sleep

Age: 40.8 ±6.9

Male: 30.2% BMI: 38.2 ±5.9 kg/m2

ESS: 8.6 ±4.4

AHI: NR

139 Type IV Sleep

Study (Apnea Risk Evaluation System,

Advanced Brain

Monitoring, Inc)

RDI: sum of abnormal respiratory

events per hour of sleep Hypopneas: 50 to 90% decrease in

nasal flow with a >3.5% oxygen

desaturation OR ≥1% desaturation with ≥surrogate arousal indicator

OSA: RDI ≥15/hr

No OSA (RDI<5): 34% (47/139)

OSA: (RDI ≥5) 66% (92/139) •Mild (AHI 5-15): 37% (52/139)

•Moderate-Severe (AHI ≥15): 29%

(40/139)

ESS ≥10 RDI ≥15/hr

Koyama, 2012 Group 3 Male railroad workers

Age: 35.6 ±9.6 years Male: 100%

BMI: 26.7 ±4.1 kg/m2

ESS: 7.9 ±3.6

AHI: NR


(EMBLA Titanium)


OSAS: AHI ≥15/hr or (AHI ≥5/hr

and ESS ≥10)

No OSAS: 65% (484/745) OSAS: 35% (261/745)

•Mild: 54%

•Moderate: 25%

•Severe: 20%

ESS >10 AHI ≥15/hr or (AHI ≥5/hr and

ESS >10)

Morrell, 2012 Group 3 Wisconsin state

employees age 30-60 years

Age: 50.4 years

Male: 74% BMI: 31.1 ±7.1 kg/m2

ESS: 8.7 ±4.1

AHI: NR

3,695 Type II

Polysomnography (Polygraph model

78)


per hour of sleep Hypopneas: discernible decrease in

nasal flow with a ≥4% oxygen

OSAS: AHI ≥15/hr or on CPAP


(3089/3695) OSA: (AHI ≥15): 84% (606/3695)

ESS ≥10 AHI ≥15 (or

CPAP)

Nicholl, 2012 Group 3 Adults with chronic

kidney disease

attending an outpatient

nephrology clinic

Age: 65 ±12 years

Male: 63%

BMI: 31.2 ±8.3 kg/m2 ESS: 7.9 ±4.7

ODI(4%): 21.1 ±25.1/hr

119 Type IV Sleep

Study (Remmers

Sleep Recorder Model 4.2)

ODI: sum of number of episodes of

desaturation ≥4% per hour of

recording OSA: ODI(4%) ≥15/hr

No OSA (ODI<15): 61% (73/119)

OSA: (ODI ≥15): 39% (46/119)

ESS >10 ODI (4%)

≥15/hr

Ravesloot,

2012

Group 4 Consecutive bariatric candidates

Age: 45.1 ±10.6 years Male: 23.3%

BMI: 44.2 ±6.4 kg/m2

ESS: 4.3 ±3.8 AHI: 23.9 ±27.7/hr


(Flaga Medical)


Hypopneas: ≥30 decrease in nasal

flow with a ≥4% oxygen desaturation

OSA: AHI ≥5/hr

No OSA (AHI<5): 30% (84/279) OSA (AHI ≥5): 70% (195/279)

•Mild (AHI 5-15): 35% (67/195)

•Moderate (AHI 15-20): 25% (48/195)

•Severe (AHI ≥30): 40% (78/195)

ESS >10 (??)


AHI ≥15/hr


88

Gasa, 2011 Group 4 Consecutive

bariatric candidate

Age: 43.0 ±10.0 years

Male: 28% BMI: 46.1 ±5.8 kg/m2

ESS: 8.0 ±5.0

AHI: NR

159 Type I

Polysomnography

AHI: Not defined


No OSA (AHI<15): 28% (44/159)

OSA (AHI ≥15): 72% (115/159)

ESS ≥10 AHI ≥15/hr

Khoo, 2011 Group 4 Consecutive


a sleep clinic

Age: 47.5 ±13.9 years

Male:79%

BMI: 28.5 ±5.8 kg/m2 ESS: NR

AHI: NR

117 Type I

Polysomnography

(Compumedics E Series)


per hour of sleep

Hypopneas: ≥20% reduction in nasal flow with a >3% oxygen

desaturation

OSA: AHI ≥20/hr

No OSA (AHI <20): 34% (40/117)

OSA (AHI ≥20): 66% (77/117)

ESS ≥10 AHI ≥20/hr

Kopitovic,

2011

Group 4 Sleep clinic patients

with OSA

symptoms undergoing sleep

study evaluations

Age: 53 (median, IQR 43-

59)

Male: 78% BMI: 28 kg/m2 (median,

IQR 25-32)

ESS: 9 (median, IQR 6-12) AHI: 17.4/hr (median, IQR

1.4-43.7)

112 Type I

Polysomnography

(SomnoStar, Viasys)


per hour of sleep


OSA: AHI ≥5/hr

No OSA (AHI<5): 38% (42/112)

OSA (AHI ≥5): 62% (70/112)

•Mild (AHI 5-15): NR •Moderate (AHI 15-20): NR

•Severe (AHI ≥30): NR

Various:

ESS ≥5

ESS ≥10

AHI ≥5/hr

Martinez, 2011 Group 4 Consecutive adult patients undergoing

sleep study testing for suspected OSA

•performed ESS immediately before

and day after PSG.

Pre-PSG ESS used in this analysis.

Age: 46 ±14 years Male: 63.5%

BMI: 27 ±5.3 kg/m2 ESS: 10 ±5.1

AHI: 24 ±22/hr



Hypopneas: ≥50% decrease in nasal flow with either a ≥3%

oxygen desaturation or a 3-s EEG

arousal OSA: AHI ≥5/hr

No OSA (AHI<5): 16% (149/929) OSA (AHI ≥5): 84% (780/929)

•Mild (AHI 5-15): 29.8% (232/780)

•Moderate (AHI 15-20): 26.4%

(206/780) •Severe (AHI ≥30): 43.8%

(342/780)

ESS >10 AHI ≥5/hr

Sareli, 2011 Group 3 Consecutive

patients evaluated for bariatric surgery

and referred for a

sleep study (11/2005-1/2007) at

the Penn Sleep

Clinic for various reasons

Age: 43.8 ±10.9 years

Male: 18.4% BMI: 49.5 ±10.0 kg/m2

ESS: 8.7 ±5

AHI: 24.9 ±30.3/hr

342 Type I

Polysomnography (Sandman Elite

software)


per hour of sleep Hypopneas: 30 to 99% decrease in

nasal flow with either a ≥3%


OSA: AHI ≥5/hr

No OSA (AHI<5): 23% (78/342)

OSA (AHI ≥5): 77% (264/342) •Mild (AHI 5-15): 40% (105/264)


(66/264) •Severe (AHI ≥30):35% (93/264)

Various:

ESS >10 ESS ≥10

ESS ≥16

Various:


AHI ≥30/hr

Sert

Kuniyoshi,

2011

Group 3 Cross-sectional

study of recent MI patients (1 to 3

months prior).

Excluded patients with prior OSA

Age: 62 ±13 years

Male: 81% BMI: 30 ±5 kg/m2

ESS: 9.1 ±4.2

AHI: NR

99 Type I

Polysomnography (Compumedics)


per hour of sleep Hypopneas: 30 to 90% decrease in


desaturation OSA: AHI ≥5/hr

No OSA (AHI<5): 26% (26/99)

OSA (AHI ≥5): 74% (73/99) •Mild (AHI 5-15): 37% (27/73)


(25/73) •Severe (AHI ≥30): 29% (21/73)

ESS ≥10

AHI ≥5/hr


89

diagnosis receiving

CPAP treatment.

Silva, 2011 Group 4 Sleep Heart Health

Study (SHHS) –

Population study in subjects age >40

years

Age:62.4 ±10.3 years

Male: 52%

BMI: NR (35% had BMI ≥30 kg/m2)

ESS: NR (28% ESS >11)

AHI: NR

4770 Type II

Polysomnography

(Compumedics portable PS-2

system)


per hour of sleep

Hypopneas: ≥25% decrease in nasal flow with a ≥4% oxygen

desaturation

OSA: AHI ≥5/hr

No OSA (AHI<5): 87% (4167/4770)

OSA (AHI ≥5): 13% (603/4770)

>Moderate (AHI 15-20): 43% (258/603)

>Severe (AHI ≥30): 57%

(345/603)

ESS >10 Various:

AHI ≥15/hr

AHI ≥30/hr

Subramanian,

2011

Group 3 Consecutive

patients referred for

suspected sleep apnea (no prior

OSA Diagnosis)

Age: 55 ±14 years

Male: 59%


RDI: 38 ±8/hr

509 •Type I

Polysomnography

RDI: sum of apneas, hypopneas

and RERA’s per hour of sleep

Hypopneas: required ≥4% oxygen desaturation in addition to defined

reduction in airflow per 2007

American Academy of Sleep Medicine Scoring Guidelines

RERA’s: NR

OSA: RDI ≥5

No OSA (RDI<5): 15% (77/509)

OSA: (RDI ≥5): 85% (432/509)

•Mild: 31% (134/432) •Moderate/Severe (RDI ≥15): 69%

(298/432)

ESS >10 Various:

RDI ≥5/hr

RDI ≥15/hr

Tanaka, 2011 Group 3 Male passenger

transportation

workers (train and bus drivers, rail

conductors,

mechanics)


Male: 100%

BMI: NR ESS: NR

AHI: NR

75 Pulse Oximeter

(Pulsox-3, Konica

Minolta)

ODI: sum of ≥3% desaturations

per hour of recording


No OSA (ODI(3%) <15): 85%

(607/715)

OSA: (ODI(3%) ≥15): 15% (108/715)

ESS >10 ODI (3%)

≥15/hr





90

Table 21 - AHRQ Question 1b – Diagnostic Accuracy of Epworth Sleepiness Scale (ESS) Diagnostic Studies

Study N Cut-Point(s) OSA

Prevalence


Odds Ratio

p-

value


Probability

Neg

Posttest

Probability

Kappa(1)

Coefficient

Sharkey, 2013 269 AHI ≥15/hr

ESS ≥10

0.584 Bariatric

surgery

candidates

50 107 20 84 0.224 0.318 0.750 0.641 0.440 1.274 0.909 0.498 NR 0.641 0.560

269 AHI ≥30/hr

ESS ≥10

0.297 Bariatric

surgery

candidates

29 51 49 140 0.088 0.363 0.741 0.372 0.733 1.398 0.861 0.628 NR 0.372 0.267

Vana, 2013 47 AHI ≥5/hr

ESS >10

0.681 New sleep

clinic patients

10 22 7 8 0.519 0.305 0.313 0.533 0.588 0.267 0.670 1.289 0.383 0.423 0.588 0.733 -0.290

Albuquerque,

2012

151 AHI ≥5/hr

ESS >10

0.781 Afib patients

for DCCV

38 80 15 18 0.570 0.159 0.322 0.545 0.717 0.184 0.708 1.243 0.371 NR 0.717 0.816 -0.295

151 AHI ≥15/hr

ESS >10

0.523 Afib patients

for DCCV

23 56 30 42 0.575 0.107 0.291 0.429 0.434 0.429 0.699 1.215 0.430 NR 0.434 0.571 -0.187

151 AHI ≥5/hr

ESS ≥10

0.781 Afib patients

for DCCV

46 72 18 15 0.532 0.109 0.390 0.455 0.719 0.172 0.715 1.342 0.404 NR 0.719 0.828 -0.287

Asha’ari, 2012 240 AHI ≥5/hr

ESS ≥10

0.675 HTN and non-

HTN patients

56 106 24 54 1.19 0.559 0.346 0.692 0.700 0.338 1.123 0.945 0.458 NR 0.700 0.663 0.077

230 AHI ≥5/hr

ESS ≥14

0.675 HTN and non-

HTN patients

38 124 14 64 0.332 0.235 0.821 0.731 0.340 1.307 0.933 0.425 NR 0.731 0.660

Danzi-Soares,

2012

70 AHI ≥5/hr

ESS >10

0.871 CABG

patients

16 45 1 8 22.59 <0.001 0.262 0.889 0.941 0.151 2.361 0.830 0.343 NR 0.941 0.849 0.542

70 AHI ≥15/hr

ESS >10

0.543 CABG

patients

8 30 9 23 0.681 0.492 0.211 0.719 0.471 0.434 0.749 1.098 0.443 NR 0.471 0.566 -0.158

Facco, 2012 100 AHI ≥5/hr

ESS ≥10

0.280 Pregnant

women at

high risk for

OSA

10 18 17 55 22.59 0.221 0.357 0.764 0.370 0.753 1.513 0.742 0.650 0.57 0.370 0.247 0.126

Feng, 2012 2297 AHI ≥5/hr

ESS >10

0.907 Sleep clinic

patients

808 1276 24 189 4.899 <0.001 0.388 0.887 0.971 0.129 3.44 0.690 0.434 NR 0.971 0.871 0.689

2297 AHI ≥15/hr

ESS >10

0.724 Sleep clinic

patients

725 939 107 526 22.59 <0.001 0.436 0.831 0.871 0.359 2.578 0.679 0.545 NR 0.871 0.641 0.533

2297 AHI ≥30/hr

ESS >10

0.524 Sleep clinic

patients

607 597 225 868 <0.001 0.504 0.794 0.730 0.592 2.449 0.624 0.642 NR 0.730 0.408

Gjevre, 2012 25 AHI ≥5/hr

ESS >10

0.680 Rheumatoid

arthritis

patients

8 9 2 6 2.326 0.294 0.471 0.750 0.800 0.400 1.882 0.706 0.560 NR 0.800 0.600 0.375

Knutson, 2012 134 RDI ≥15/hr

ESS >10

0.299 Obese patients

reporting <6.5

hrs of sleep

14 26 29 65 1.215 0.638 0.350 0.691 0.326 0.714 1.134 0.940 0.590 NR 0.326 0.286 0.039

Koyama, 2012 745 AHI ≥15/hr or

(AHI ≥5/hr and

0.350 Male railroad

workers

114 147 122 362 <0.001 0.437 0.748 0.483 0.711 1.73 0.753 0.639 NR 0.483 0.289


91

ESS ≥10)

ESS ≥10

Morrell, 2012 3695 AHI ≥15 (or CPAP)

ESS ≥10

0.164 Wisconsin

state

employees

304 302 1208 1881 <0.001 0.502 0.609 0.201 0.862 1.283 0.818 0.591 NR 0.201 0.138

Nicholl, 2012 119 ODI (4%)

≥15/hr

ESS >10

0.387 Chronic

kidney disease

patients

18 28 14 59 2.664 0.017 0.391 0.808 0.563 0.678 2.040 0.753 0.647 NR 0.563 0.322 0.287

Ravesloot, 2012 279 AHI ≥5/hr

ESS >10 (??)

0.699 Bariatric

patients

. . . . . . . . . . . . . 0.540 . . .

279 AHI ≥15/hr

ESS >10 (??)

0.451 Bariatric

patients

. . . . . . . . . . . . . 0.590 . . .

Gasa, 2011 159 AHI ≥15/hr

ESS >10

0.723 Bariatric

patients

32 83 10 34 1.279 0.514 0.278 0.773 0.762 0.291 1.224 0.934 0.415 NR 0.762 0.709 0.140

Khoo, 2011 117 AHI ≥20/hr

ESS ≥10

0.658 Sleep clinic

patients

56 21 26 14 0.387 0.727 0.350 0.683 0.400 1.119 0.779 0.598 NR 0.683 0.600

Kopitovic, 2011 112 AHI ≥5/hr

ESS ≥5

0.625 Sleep clinic

patients

67 3 30 12 <0.001 0.957 0.286 0.691 0.800 1.34 0.15 0.705 NR 0.691 0.200

112 AHI ≥5/hr

ESS ≥10

0.625 Sleep clinic

patients

50 20 5 37 16.79 <0.001 0.714 0.881 0.909 0.649 6.00 0.324 0.777 0.850 0.909 0.351 0.758

Martinez, 2011 929 AHI ≥5/hr

ESS >10

0.840 Sleep clinic

patients

421 359 55 94 1.996 <0.001 0.540 0.631 0.884 0.208 1.462 0.730 0.554 NR 0.884 0.792 0.280

Sareli, 2011 342 AHI ≥5/hr

ESS >10

0.772 Bariatric

patients

93 171 18 60 1.783 0.044 0.352 0.769 0.838 0.260 1.527 0.842 0.447 NR 0.838 0.740 0.289

342 AHI ≥5/hr

ESS ≥10

0.772 Bariatric

patients

110 154 23 55 1.689 0.053 0.417 0.705 0.827 0.263 1.413 0.827 0.482 NR 0.827 0.737 0.242

342 AHI ≥15/hr

ESS >10

0.465 Bariatric

patients

60 99 51 132 1.564 0.052 0.377 0.721 0.541 0.571 1.354 0.863 0.561 NR 0.541 0.429 0.141

342 AHI ≥15/hr

ESS ≥10

0.465 Bariatric

patients

71 88 62 121 0.042 0.447 0.661 0.534 0.579 1.318 0.837 0.561 NR 0.534 0.421

Sert Kuniyoshi,

2011

99 AHI ≥5/hr

ESS >10

0.737 Recent MI 26 47 8 18 1.214 0.655 0.356 0.692 0.765 0.277 1.158 0.930 0.444 0.58 0.765 0.723 0.104

Silva, 2011 4770 AHI ≥15/hr

ESS >10

0.126 Population

study (SHHS)

235 368 1192 2975 1.595 <0.001 0.390 0.714 0.165 0.890 1.362 0.855 0.673 0.53 0.165 0.110

4770 AHI ≥30/hr

ESS >10

0.072 Population

study (SHHS)

159 186 1310 3115 <0.001 0.461 0.704 0.108 0.944 1.557 0.766 0.686 0.58 0.108 0.056 0.044

Subramanian,

2011

509 RDI ≥5/hr

ESS >10

0.849 Suspected

OSA

233 199 34 43 1.476 0.113 0.539 0.558 0.873 0.178 1.221 0.825 0.542 NR 0.873 0.822 0.158

509 RDI ≥15/hr

ESS >10

0.585 Suspected

OSA

170 128 99 112 1.500 0.024 0.570 0.531 0.632 0.467 1.216 0.809 0.554 0.591 0.632 0.533 0.112

Tanaka, 2011 715 ODI (3%)

≥15/hr

ESS >10

0.151 Male

transportation

workers

18 90 107 500 0.952 0.809 0.167 0.824 0.144 0.847 0.945 1.012 0.724 NR 0.144 0.153 -0.008


92

* Abbreviations: +LR (positive likelihood ratio), -LR (negative likelihood ratio), AHI (apnea-hypopnea index), AUC (area under the curve), CABG (coronary artery bypass graft), CAD (coronary artery disease), COPD

(chronic obstructive pulmonary disease), CPAP (continuous positive airway pressure), FN (false negative), FP (false positive), N (number), NR (not reported), NPV (negative predictive value), MI (myocardial infarction), ODI (oxygen desaturation index), OSA (obstructive sleep apnea), OSAS (obstructive sleep apnea syndrome), PPV (positive predictive value), PSG (polysomnogram), RDI (respiratory disturbance index), Sen (sensitivity),

Spec (specificity), TN (true negative), TP (true positive)


93

Table 22 - AHRQ Question 1a – Summary of Multivariate Apnea Prediction Index (MAPI) Diagnostic Studies

Study Search

Strategy

Sample Demographics N Validation OSA Definition OSA Prevalence MAP

Cut-point(s)

AHI

Cut-Point(s)

Morales,

2012

Group 4 Elderly patients (population study) with

and without sleepiness


BMI: 30.5 ±7.6

kg/m2 ESS: NR (30% ESS

>10)

AHI: NR


(Sandman, Embla)



in nasal flow with either a ≥3% oxygen or EEG

arousals


No OSA: 73% (70/92) OSA (AHI ≥5 & ESS >10): 27%

(22/92)

•Mild (AHI 5-15 & ESS >10): 32% (7/22)

•Moderate (AHI 15-30 & ESS >10):

23% (5/22) •Severe (AHI ≥30 & ESS >10):

45% (10/22)

MAPI >0.5 AHI ≥30/hr & ESS >10

Sharwood,

2012

Group 4 Random sample of long distance commercial truck

drivers

Age: 46.4 years Male: 99%

BMI: 30.6 kg/m2

ESS: 5.9 AHI: 19.5 ±15/hr

MAPI: NR

325 Type IV sleep study (flow monitor,

DiagnoseIT)


OSA: AHI ≥18/hr

No OSA (AHI<18): 41% (132/325) OSA: (AHI ≥18): 59% (193/325)

>Severe (AHI ≥30): 39%

(52/193)

MAPI >0.5 AHI ≥18/hr

Sareli, 2011 Group 3 Consecutive patients evaluated for bariatric

surgery and referred for a sleep study (11/2005-

1/2007) at the Penn Sleep

Clinic for various reasons

Age: 43.8 ±10.9 years

Male: 18.4% BMI: 49.5 ±10.0

kg/m2

ESS: 8.7 ±5 AHI: 24.9 ±30.3/hr


(Sandman Elite software)


Hypopneas: 30 to 99% decrease in nasal flow with



OSA: AHI ≥5/hr

No OSA (AHI<5): 23% (78/342) OSA (AHI ≥5): 77% (264/342)

•Mild (AHI 5-15): 40% (105/264)


(66/264) •Severe (AHI ≥30):35% (93/264)

Various: MAPI

score > and/or =

0.1 to 1.0






breathing)


94

Table 23 - AHRQ Question 1b – Diagnostic Accuracy of Multivariate Apnea Prediction Index (MAPI) Diagnostic Studies

Study N Cut-Point(s) Population OSA

Prevalence

TP FN FP TN p-value Sens Spec PPV NPV +LR -LR Accuracy AUC Pos Posttest

Probability

Neg Posttest

Probability

Morales, 2012 92 •AHI ≥30/hr & ESS >10

•MAPI ≥0.5

Elderly patients with

and without

sleepiness

0.109 9 1 29 53 <0.001 0.900 0.646 0.237 0.981 2.545 0.155 0.674 0.776 0.237 0.019

Sharwood, 2012 325 •AHI ≥18/hr

•MAPI ≥0.5

Commercial

truck drivers

0.406 74 58 81 112 0.013 0.561 0.580 0.477 0.659 1.366 0.757 0.572 NR 0.477 0.341

Sareli, 2011 258 •AHI ≥5/hr

•MAPI ≥0.5

Bariatric

candidates

0.779 168 33 31 26 <0.001 0.836 0.456 0.844 0.441 1.537 0.360 0.752 NR 0.844 0.559

258 •AHI ≥15/hr

•MAPI ≥0.5

Bariatric

candidates

0.481 106 18 93 41 0.002 0.855 0.306 0.533 0.695 1.232 0.474 0.570 NR 0.533 0.305


obstructive pulmonary disease), CPAP (continuous positive airway pressure), FN (false negative), FP (false positive), N (number), NR (not reported), NPV (negative predictive value), MI (myocardial infarction), ODI (oxygen

desaturation index), OSA (obstructive sleep apnea), OSAS (obstructive sleep apnea syndrome), PPV (positive predictive value), PSG (polysomnogram), RDI (respiratory disturbance index), Sen (sensitivity), Spec (specificity), TN (true negative), TP (true positive)


95

Table 24 - AHRQ Question 1b – Summary of Pittsburgh Sleep Quality Index (PSQI) Diagnostic Studies

Study Search

Strategy

Sample Demographics N Validation OSA Definition OSA Prevalence PSQI

Cut-point(s)

AHI

Cut-Point(s)

Knutson,

2012

Group 3 Obese (BMI 30-55) men and premenopausal

women aged 18-50 years

reporting less than 6.5 hrs of sleep


Male: 30.2%

BMI: 38.2 ±5.9 kg/m2

ESS: 8.6 ±4.4

AHI: NR PSQI: 9.0 ±3.4

139 Type IV Sleep Study (Apnea Risk

Evaluation System,

Advanced Brain Monitoring, Inc)

RDI: sum of abnormal respiratory events per hour of

sleep

Hypopneas: 50 to 90% decrease in nasal flow with a >3.5%

oxygen desaturation OR ≥1%

desaturation with ≥surrogate arousal indicator

OSA: RDI ≥15/hr

No OSA (RDI<5): 34% (47/139) OSA: (RDI ≥5) 66% (92/139)

•Mild (AHI 5-15): 37% (52/139)

•Moderate-Severe (AHI ≥15): 29% (40/139)

PSQI >5 AHI ≥15/hr

Nicholl,

2012

Group 3 Adults with chronic kidney disease attending

an outpatient nephrology

clinic


BMI: 31.2 ±8.3

kg/m2 ESS: 7.9 ±4.7

ODI(4%): 21.1

±25.1/hr

119 Type IV Sleep Study (Remmers

Sleep Recorder

Model 4.2)

ODI: sum of number of episodes of desaturation ≥4%

per hour of recording


No OSA (ODI<15): 61% (73/119) OSA: (ODI ≥15): 39% (46/119)

PSQI >5 ODI(4%) ≥15/hr

Bertolazi,

2011

Group 4 Consecutive sleep clinic

patients undergoing sleep

study evaluations

Age: 46.6 ±11.0

years

Male: 42% BMI: 38.3 ±6.8

kg/m2

ESS: NR AHI: 16.3

±23.0/hr

PSQI: 10.8 ±4.7

83 “Polysomnography” AHI: NR

Hypopneas: NR

OSA: “per standards established by the American

Academy of Sleep Medicine

(AASM)”

No OSA (AHI<5): 52% (43/83)

OSA: (AHI ≥5): 48% (40/83)

PSQI >5 AHI ≥5/hr


positive airway pressure), DM (diabetes mellitus), EEG (electroencephalogram), ESS (Epworth sleepiness scale), hr (hour), IQR (interquartile range), MI (myocardial infarction), N (number), NR (not reported),

OSA (obstructive sleep apnea), OSAS (obstructive sleep apnea syndrome), mod (moderate), PSG (polysomnogram), RDI (respiratory disturbance index), RERA (respiratory effort related arousal), SDB (sleep

disordered breathing)


96

Table 25. AHRQ Question 1b – Diagnostic Accuracy of Pittsburgh Sleep Quality Index (PSQI) Diagnostic Studies


Prevalence

Population TP FN FP TN p-value Sens Spec PPV NPV +LR -LR Accuracy AUC Pos

Posttest

Probability

Neg Posttest

Probability

Knutson,

2012

128 AHI ≥15/hr

PSQI >5

0.281 Obese patients

reporting <6.5 hrs

of sleep

5 31 13 79 0.972 0.139 0.859 0.278 0.718 0.983 1.003 0.656 NR 0.278 0.282

Nicholl,

2012

119 ODI(4%)

≥15/hr

PSQI >5

0.387 Chronic kidney

disease patients

21 25 31 42 0.733 0.457 0.575 0.404 0.627 1.075 0.945 0.529 NR 0.404 0.373

Bertolazi,

2011

83 AHI ≥5/hr

PSQI ≥5

0.518 Sleep clinic

patients

31 12 40 0 <0.001 0.721 0 0.437 0 0.721 2233.5 0.373 NR 0.437 1.0

* Abbreviations: +LR (positive likelihood ratio), -LR (negative likelihood ratio), AHI (apnea-hypopnea index), AUC (area under the curve), CABG (coronary artery bypass graft), CAD (coronary artery disease), COPD (chronic obstructive pulmonary disease), CPAP (continuous positive airway pressure), FN (false negative), FP (false positive), N (number), NR (not reported), NPV (negative predictive value), MI (myocardial infarction), ODI (oxygen

desaturation index), OSA (obstructive sleep apnea), OSAS (obstructive sleep apnea syndrome), PPV (positive predictive value), PSG (polysomnogram), RDI (respiratory disturbance index), Sen (sensitivity), Spec (specificity), TN

(true negative), TP (true positive)


97

Table 26 - AHRQ Question 1b – Summary of STOP-BANG Questionnaire Diagnostic Studies

Study Search

Strategy

Sample Demographics N Validation OSA Definition OSA Prevalence STOP-BANG

Cut-point(s)

AHI

Cut-Point(s)

Vana, 2013 Group 4 New adult (age ≥18 years) patients referred to clinic for

sleep evaluations.


using various BMI criteria

including >35 or >30

Age: 46.4 ±13.2 years Male: 34%

BMI: 36.3 ±9.2 kg/m2



range 0 -99.9)


(diagnostic or

split-night protocols)




OSA: AHI ≥5/hr

No OSA (AHI <5): 32% (15/47) OSA (AHI ≥5): 68% (32/47)

•Mild (AHI 5-15): 48% (15/47)

•Moderate (AHI 15-30): 25% (8/47)

•Severe (AHI ≥30): 28% (9/47)

≥3 points

AHI ≥5/hr

Chung, 2012 Group 4 Patients scheduled for surgery

attending preoperative clinic

Age: 60 years (range

51-68)

Male: 48% BMI: 30 kg/m2 (range

26-34)

ESS: NR AHI:NR

746 Type 2 Portable

Sleep Study

(Embletta X-100)



Hypopneas: “scored according to the American Academy of

Sleep Medicine Task Force

recommendations” OSA:AHI ≥5/hr

No OSA (AHI<5): 32% (236/746)

OSA: (AHI ≥5): 68% (510/746)

•Mild (AHI 5-15): 44% (223/510)


(153/236) •Severe (AHI ≥30): 26%

(134/236)

Various:

≥2 points

≥3 points ≥5 points

Various:

AHI ≥5/hr

AHI ≥15/hr

AHI

≥30/hr:

Farney,

2011

Group 3 Consecutive patients referred to a sleep clinic who

underwent PSG testing for

any reason (1/2006-12/2008)

Age: 49.7 ±15.2 years Male: 57.2%

BMI: 33.8 ±8.1 kg/m2

ESS: NR AHI:32.9 ±30.1/hr

1,426 Type 1 Polysomnogram

(17 channel;

Cadwell lab)


Hypopneas: studies prior to

4/2007, scoring based on “earlier” ‘Chicago’ criteria; after

this date based on AASM 2007

standards

OSA: AHI ≥5/hr

No OSA (AHI<5): 10.5% (150/1424)

OSA: 89.5% (1274/1424)

•Mild (AHI 5-15): 24.7% (315/1424)

•Moderate (AHI 15-30): 29.7%

(379/1274)

•Severe (AHI ≥30): 45.5%

(580/1274)

Various: ≥1 points

≥2 points

≥3 points ≥4 points

≥5 points

≥6 points


AHI

≥15/hr AHI

≥30/hr

Silva, 2011 Group 4 Sleep Heart Health Study – Population study in subjects

age >40 years

Age:62.4 ±10.3 years Male: 52%

BMI: NR (35% had BMI

≥30 kg/m2) ESS: NR (28% ESS

>11)

AHI: NR

4770 Type II Polysomnography

(Compumedics

portable PS-2 system)




OSA: AHI ≥5/hr

No OSA (AHI<5): 87% (4167/4770)

OSA (AHI ≥5): 13% (603/4770)

•Moderate (AHI 15-20): 43% (258/603)


(345/603)

≥3 points

Various: AHI

≥15/hr

AHI ≥30/hr

Ong, 2010 Group 4 Consecutive sleep clinic

patients (95% evaluated for

suspected sleep apnea)


using various BMI cut-points: BMI ≥26, BMI ≥30, BMI ≥35

Age: 47 ±15.2 years

Male: 71%

BMI: 27.8 ±5.9 kg/m2

ESS: 9.4 ±5.2

AHI: 26.2 ±26.9/hr

317 Type 1

Polysomnogram




nasal flow with either a ≥4%

oxygen desaturation OR ≥3%

oxygen and an EEG arousal OSA: AHI ≥5/hr

No OSA (AHI<5): 25% (78/317)

OSA: 75% (239/317)

•Mild (AHI 5-15): 33% (79/239)


(51/239)

•Severe (AHI ≥30): 46% (109/239)

≥3 points

Various:

AHI ≥5/hr

AHI

≥15/hr

AHI

≥30/hr




98


breathing)


99

Table 27 - AHRQ Question 1b – Diagnostic Accuracy of STOP-BANG (BMI >35) Questionnaire Diagnostic Studies


Prevalence


Odds Ratio

p-

value


Probability

Neg

Posttest

Probability

Kappa(1)

Coefficient

Vana, 2013 47 STOP-BANG ≥3

points

AHI ≥5/hr

0.681 New sleep clinic

patients

30 2 10 5 7.500 0.015 0.938 0.333 0.750 0.714 1.406 0.188 0.745 0.490 0.750 0.286 0.217

Chung,

2012

746 STOP-BANG ≥2

points

AHI ≥5/hr

0.684 Elective surgery

candidates

488 22 194 42 <0.001 0.957 0.178 0.716 0.656 1.164 0.242 0.710 0.650 0.716 0.344

746 STOP-BANG ≥2

points

AHI ≥15/hr


candidates

283 4 399 60 <0.001 0.986 0.131 0.415 0.938 1.134 0.107 0.460 0.670 0.415 0.063

746 STOP-BANG ≥2

points

AHI ≥30/hr


candidates

134 0 548 64 <0.001 1.00 0.105 0.196 1.00 1.117 0.000 0.265 0.710 0.196 0.000

746 STOP-BANG ≥3

points

AHI ≥5/hr


candidates

429 81 141 95 3.568 <0.001 0.841 0.403 0.753 0.540 1.408 0.395 0.702 0.650 0.753 0.460 0.218

746 STOP-BANG ≥3

points

AHI ≥15/hr


candidates

256 31 314 145 3.813 <0.001 0.892 0.316 0.449 0.824 1.304 0.342 0.538 0.670 0.449 0.176 0.105

746 STOP-BANG ≥3

points

AHI ≥30/hr


candidates

127 7 443 169 6.921 <0.001 0.948 0.276 0.223 0.960 1.309 0.189 0.397 0.710 0.223 0.040 0.053

746 STOP-BANG ≥5

points

AHI ≥5/hr


candidates

185 325 48 188 <0.001 0.363 0.797 0.794 0.366 1.783 0.800 0.500 0.650 0.794 0.634

746 STOP-BANG ≥5

points

AHI ≥15/hr


candidates

126 161 107 352 <0.001 0.439 0.767 0.541 0.686 1.883 0.731 0.641 0.670 0.541 0.314

746 STOP-BANG ≥5

points

AHI ≥30/hr


candidates

75 59 158 454 <0.001 0.560 0.742 0.322 0.885 2.168 0.594 0.709 0.710 0.475 0.130

Farney,

2011

1424 STOP-BANG ≥2

points

AHI ≥5/hr


1424 STOP-BANG ≥2

points

AHI ≥15/hr


1424 STOP-BANG ≥2

points

AHI ≥30/hr


1424 STOP-BANG ≥3

points

AHI ≥5/hr

0.895 Sleep clinic patients 1139 135 63 87 22.588 <0.001 0.894 0.580 0.948 0.392 2.129 0.183 0.861 NR 0.948 0.608 0.502

1424 STOP-BANG ≥3

points

AHI ≥15/hr


1424 STOP-BANG ≥3

points



100

AHI ≥30/hr

1424 STOP-BANG ≥5

points

AHI ≥5/hr


1424 STOP-BANG ≥5

points

AHI ≥15/hr


1424 STOP-BANG ≥5

points

AHI ≥30/hr


Silva, 2011 4770 STOP-BANG ≥3

points

AHI ≥15/hr

0.126 Population study

(SHHS)

525 78 2363 1804 4.923 <0.001 0.871 0.433 0.182 0.959 1.535 0.299 0.488 0.640 0.182 0.041 0.063

4770 STOP-BANG ≥3

points

AHI ≥30/hr

0.072 Population study

(SHHS)

243 102 1792 2633 3.765 <0.001 0.704 0.595 0.119 0.963 1.739 0.497 0.603 0.660 0.119 0.037 0.051

Ong, 2010 317 STOP-BANG ≥3

points

AHI ≥5/hr

0.754 Consecutive

sleep clinic

patients

203 36 37 41 6.170 <0.001 0.849 0.526 0.846 0.532 1.791 0.287 0.770 0.775 0.856 0.468 0.373

317 STOP-BANG ≥3

points

AHI ≥15/hr

0.505 Consecutive

sleep clinic

patients

146 14 94 63 7.032 <0.001 0.913 0.401 0.608 0.818 1.524 0.218 0.659 0.775 0.608 0.182 0.209

317 STOP-BANG ≥3

points

AHI ≥30/hr

0.344 Consecutive

sleep clinic

patients

104 5 136 72 11.101 <0.001 0.954 0.346 0.433 0.935 1.459 0.133 0.555 0.772 0.433 0.065 0.136

* Abbreviations: +LR (positive likelihood ratio), -LR (negative likelihood ratio), AHI (apnea-hypopnea index), AUC (area under the curve), CABG (coronary artery bypass graft), CAD (coronary artery disease), COPD (chronic obstructive pulmonary disease), CPAP (continuous positive airway pressure), FN (false negative), FP (false positive), N (number), NR (not reported), NPV (negative predictive value), MI (myocardial infarction), ODI (oxygen

desaturation index), OSA (obstructive sleep apnea), OSAS (obstructive sleep apnea syndrome), PPV (positive predictive value), PSG (polysomnogram), RDI (respiratory disturbance index), Sen (sensitivity), Spec (specificity), TN

(true negative), TP (true positive)


101

Table 28 - AHRQ Question 1b – Summary of Other OSA Diagnostic Questionnaires

Study Search

Strategy

Sample Demographics N Validation OSA Definition OSA Prevalence Cut-point(s) AHI

Cut-Point(s)

Sharkey, 2013 Group 4 Patients evaluated for bariatric

surgery

•Evaluated Functional Outcomes

of Sleep Questionnaire (FOSQ)


Male: 11% BMI: 50.2 ±7.7 kg/m2

ESS: 6.3 ±4.8

AHI: 29.5 ±31.5/hr

269 Type I

Polysomnography


hypopneas per hour of sleep Hypopneas: ≥50% decrease in

nasal flow with a >3% oxygen


No OSA (AHI <15): 42%

(112/269) OSA (AHI ≥15): 58%

(157/269)

•Moderate (AHI 15-30): 49% (77/157)


(80/157)

Various:

FOSQ ≤90 FOSQ ≤70

Various:

AHI ≥15/hr

AHI

≥30/hr

Vana, 2013 Group 4 New adult (age ≥18 years)

patients referred to clinic for sleep

evaluations.

•Evaluated ESS >10 or STOP-

BANG ≥3

•Evaluated STOP-BANG using

various BMI criteria including

>35 or >30

Age: 46.4 ±13.2 years

Male: 34%

BMI: 36.3 ±9.2 kg/m2



range 0 -99.9)

47 Type I

Polysomnography

(diagnostic or split-

night protocols)





OSA: AHI ≥5/hr

No OSA (AHI <5): 32% (15/47)

OSA (AHI ≥5): 68% (32/47)

•Mild (AHI 5-15): 48%

(15/47) •Moderate (AHI 15-30): 25%

(8/47)

•Severe (AHI ≥30): 28% (9/47)

ESS >10 or

STOP-BANG

≥3 points

AHI ≥5/hr

Senchak, 2012 Group 4 Multi-institutional, prospective

clinical trial in adult (age ≥18

years) patients (active duty army) undergoing tonsillectomy for

chronic, recurrent tonsillitis

•Two questionnaires used to

assess pretest probability of OSA

– High pretest probability for OSA defined as an ESS ≥8 and a

positive Berlin snore score

(Berlin category 1 score ≥2)


Male: 48%

BMI: 27.7 ±5.8 kg/m2 ESS: NR

AHI: 4.7 ±9.6/hr

77 Type IV Sleep Study

(ApneaLink Plus,

Resmed)

AHI: NR

Hypopneas: NR

OSA: AHI ≥5/hr

No OSA (AHI<5): 20% (15/77)

OSA: (AHI ≥5): 80% (52/77)

•Mild: NR •Moderate: NR

•Mild: NR

ESS ≥8 and a

positive Berlin

snore score (Berlin

category 1

score ≥2)

AHI ≥5/hr

Chai-Coetzer,

2011

Group 3 Adult patients attending six

primary care clinics

•Evaluated two-stage screening

model incorporating BOTH OSA

50 questionnaire (Obesity,

snoring, apnea, age 50; ≥5/10)

and 3%ODI (≥16/hr)

Age: 50 years (range 40-

58)

Male:44% BMI: 29.3 kg/m2 (range

25.5-33.8)

ESS: 7 (range 5-10)

AHI: 16.5/hr (range 9.6-

28.2)

78 Type I

Polysomnogram

AHI: NR

Hypopneas: Either ≥50%

decrease in nasal flow or a ≥3% oxygen desaturation or an

EEG arousal

OSA: AHI ≥30/hr

No OSA (AHI <30): 79%

(62/78)

OSA (AHI ≥30): 21% (16/78) •Mild: NR

•Moderate: NR

•Mild: NR

OSA 50

questionnaire

(≥5/10) AND 3%ODI

(≥16/hr)

AHI

≥30/hr

Enciso, 2011 Group 4 Patients of the USC School of Dentistry

Age: 54.9 ±12.1 years Male: 77%

BMI: 26.6 ±18.1 kg/m2

84 Type IV Sleep Study (ARES Unicorder)


OSA: RDI ≥15/hr

No OSA (RDI<15): 37% (31/84)

OSA (RDI ≥15): 63% (53/84)

“High Risk” on ARES

Various: RDI

≥10/hr


102

•Evaluated the Apnea Risk

Evaluation System (ARES) questionnaire that combines

features of three validated

questionnaires: Berlin, Flemon’s Index and ESS.

ESS: NR

RDI: 24.3 ±18.1/hr

RDI

≥15/hr

Silva, 2011 Group 4 Sleep Heart Health Study –

Population study in subjects age >40 years

• Evaluated the Takegami 4-item

Screen

Age:62.4 ±10.3 years

Male: 52% BMI: NR (35% had BMI

≥30 kg/m2)

ESS: NR (28% ESS >11)

AHI: NR

4,770 Type II Sleep Study

(Compumedics portable PS-2 system)


hypopneas per hour of sleep Hypopneas: ≥25% decrease in



No OSA (AHI<5): 87%

(4167/4770) OSA (AHI ≥5): 13%

(603/4770)

•Moderate (AHI 15-20): 43% (258/603)


(345/603)

•Takegami 4-

Variable Screening tool

≥14

•STOP ≥2

Various-

AHI ≥15/hr

AHI

≥30/hr

Subramanian,

2011

Group 3 Consecutive patients referred for

suspected sleep apnea (no prior

OSA Diagnosis)

•NAMES (Neck circumference,

airway classification, comorbidities, Epworth scale,

snoring) and NAMES2 (NAMES

criteria and gender, BMI ≥30) Scores

Age: 55 ±14 years

Male: 59%


RDI: 38 ±8/hr

509 •Type I

Polysomnography

RDI: sum of apneas,


hour of sleep Hypopneas: required ≥4%

oxygen desaturation in addition

to defined reduction in airflow per 2007 American Academy

of Sleep Medicine Scoring

Guidelines RERA’s: NR

OSA: RDI ≥5

No OSA (RDI<5): 15%

(77/509)

OSA: (RDI ≥5): 85% (432/509) •Mild: 31% (134/432)

•Moderate/Severe (RDI ≥15):

69% (298/432)

NAMES ≥3

NAMES2 ≥4

Various-

RDI ≥5/hr

RDI ≥15/hr

Rodrigues,

2010

Group 3 Patients complaining of snoring and clinical history suggestive of

OSA and symptoms of daytime

sleepiness, non-restful sleep and snoring were evaluated by sleep

study.

•Friedman’s classification

(modified Mallampati scale,

pharyngeal tonsil size and BMI)

Age: 48.0 ±11.3 years Male: NR

BMI: 29.4 ±5.6 kg/m2

ESS: 11.3 ±5.1 AHI: NR



OSA: AHI ≥5/hr

No OSA (AHI <5): 10% (11/112)

OSA (AHI ≥5): 90% (101/112)

Various- Friedman ≥2

Friedman ≥3

Friedman =4

Various- AHI ≥5/hr

AHI

≥15/hr AHI

≥30/hr


airway pressure), DM (diabetes mellitus), EEG (electroencephalogram), ESS (Epworth sleepiness scale), hr (hour), IQR (interquartile range), MI (myocardial infarction), N (number), NR (not reported), OSA (obstructive

sleep apnea), OSAS (obstructive sleep apnea syndrome), mod (moderate), PSG (polysomnogram), RDI (respiratory disturbance index), RERA (respiratory effort related arousal), SDB (sleep disordered breathing)


103

Table 29 - AHRQ Question 1b – Diagnostic Accuracy of Other OSA Diagnostic Questionnaires


Prevalence


value


Probability

Neg

Posttest

Probability

Sharkey, 2013 269 •FOSQ ≤90

•PSG: AHI ≥15/hr

0.584 Bariatric surgery

candidates

52 105 31 81 0.341 0.331 0.723 0.627 0.435 1.197 0.925 0.494 NR 0.627 0.565

269 •FOSQ ≤70



candidates

21 136 11 101 0.375 0.134 0.902 0.656 0.426 1.362 0.961 0.454 NR 0.656 0.574

Vana, 2013 47 •ESS >10 or STOP-BANG ≥3 points

(BMI >35 rule)

•PSG: AHI ≥5/hr

0.681 Patients referred to

clinic for sleep

evaluations.

30 2 12 3 0.154 0.938 0.200 0.714 0.600 1.172 0.313 0.702 0.569 0.714 0.400

Senchak, 2012 77 •ESS ≥8 and a positive Berlin snore

score (Berlin category 1 score ≥2)

•PSG: AHI ≥5/hr

0.195 Patients undergoing

tonsillectomy for

chronic, recurrent

tonsillitis

12 3 25 37 0.006 0.800 0.597 0.324 0.925 1.984 0.335 0.636 NR 0.324 0.075

Chai-Coetzer,

2011

78 •OSA 50 questionnaire (≥5/10) AND

3%ODI (≥16/hr)


0.205 Adult patients

attending six

primary care clinics

14 2 11 51 <0.001 0.875 0.823 0.560 0.962 4.932 0.15 0.833 0.75 0.560 0.038

Enciso, 2011 84 •ARES High Risk

•PSG: RDI ≥10/hr

0.774 Dentistry patients 48 5 17 14 <0.001 0.906 0.452 0.738 0.737 1.651 0.209 0.738 NR 0.738 0.263

84 •ARES High Risk

•PSG: RDI ≥15/hr

0.631 Dentistry patients 57 8 8 11 <0.001 0.877 0.579 0.877 0.579 2.083 0.213 0.810 NR 0.877 0.421

Silva, 2011 4,770 •Takegami 4-item Screen ≥14


0.126 SHHS Population

Study

149 454 283 3,884 <0.001 0.247 0.932 0.345 0.895 3.638 0.808 0.845 0.590 0.345 0.105

4,770 •Takegami 4-item Screen ≥14



Study

143 202 301 4124 <0.001 0.414 0.932 0.322 0.953 6.093 0.628 0.895 0.670 0.322 0.047

4,770 •STOP ≥2



Study

374 229 1821 2346 <0.001 0.620 0.563 0.170 0.911 1.419 0.675 0.570 0.580 0.170 0.089

4,770 •STOP ≥2



Study

237 108 1792 2633 <0.001 0.687 0.595 0.117 0.961 1.696 0.526 0.602 0.670 0.117 0.039

Subramanian,

2011


•NAMES ≥3

0.849 Suspected OSA 380 52 55 22 <0.001 0.880 0.286 0.874 0.297 1.231 0.421 0.790 NR 0.874 0.703


•NAMES ≥3

0.585 Suspected OSA 271 27 162 49 <0.001 0.909 0.232 0.626 0.645 1.184 0.390 0.629 0.643 0.626 0.355


•NAMES2 ≥4

0.849 Suspected OSA 367 65 45 32 <0.001 0.850 0.416 0.891 0.330 1.454 0.362 0.784 NR 0.891 0.670


•NAMES2 ≥4

0.585 Suspected OSA 274 24 139 72 <0.001 0.919 0.341 0.663 0.750 1.396 0.236 0.680 0.669 0.663 0.250

Rodrigues, 2010 101 •PSG: AHI ≥5/hr

•Friedman ≥2

0.902 Suspected OSA 99 2 11 0 0.638 0.980 0.000 0.900 0.000 0.980 NA 0.884 NR 0.900 NA


•Friedman ≥2

0.482 Suspected OSA 54 0 56 2 0.169 1.000 0.034 0.491 1.000 1.036 0.000 0.500 NR 0.491 0.000

101 •PSG: AHI 30/hr

•Friedman ≥2

0.313 Suspected OSA 35 0 75 2 0.336 1.000 0.026 0.318 1.000 1.027 0.000 0.330 NR 0.318 0.000


104


•Friedman ≥3

0.902 Suspected OSA 63 38 4 6 0.275 0.624 0.545 0.926 0.136 1.372 0.690 0.616 NR 0.926 0.864


•Friedman ≥3

0.482 Suspected OSA 39 15 29 29 0.016 0.722 0.500 0.574 0.659 1.444 0.556 0.607 NR 0.574 0.341


•Friedman ≥3

0.313 Suspected OSA 25 10 43 34 0.118 0.714 0.442 0.368 0.773 1.279 0.647 0.527 NR 0.368 0.227


•Friedman =4

0.902 Suspected OSA 8 93 1 10 0.892 0.079 0.909 0.889 0.097 0.871 1.013 0.161 NR 0.889 0.903


•Friedman =4

0.482 Suspected OSA 6 48 3 55 0.248 0.111 0.948 0.667 0.534 2.148 0.937 0.545 NR 0.667 0.466


•Friedman =4

0.313 Suspected OSA 5 30 4 73 0.101 0.143 0.948 0.556 0.709 2.750 0.904 0.696 NR 0.556 0.291

* Abbreviations: +LR (positive likelihood ratio), -LR (negative likelihood ratio), AHI (apnea-hypopnea index), AUC (area under the curve), CABG (coronary artery bypass graft), CAD (coronary artery disease), COPD (chronic obstructive pulmonary disease), CPAP (continuous positive airway pressure), FN (false negative), FP (false positive), N (number), NR (not reported), NPV (negative predictive value), MI (myocardial infarction),

ODI (oxygen desaturation index), OSA (obstructive sleep apnea), OSAS (obstructive sleep apnea syndrome), PPV (positive predictive value), PSG (polysomnogram), RDI (respiratory disturbance index), Sen (sensitivity),



105

Table 30 - AHRQ Question 1C – Summary of OSA Clinical Prediction Rule Diagnostic Studies

Study Search

Strategy

Sample Demographics N Index/Validation OSA Definition OSA Prevalence Prediction Rule PSG

Cut-Point(s)

Jauhar,

2012

Group 4 Consecutive patients

with

suspected OSA

Age: 46.6 ±11.2 years

Male: 75%

BMI: 32.5 ±8.7 kg/m2

ESS: 11.1 ±5.4

ODI: NR (for those with OSA, median

ODI 24/hr, IQR 11-

68)

71 •Kushida Index developed previously to predict clinically

suspected OSA (variables: BMI,

neck circumference, palatal height, maxillary and mandibular

intermolar distance, overjet)

• Type IV Sleep Study

(Somnoscreen)

ODI: NR OSA: ODI ≥10/hr and

ESS ≥10

No OSA: 48% (34/71) OSA (ODI ≥10 and ESS ≥10): 52%

(37/71)

•Mild or Borderline: 46% (17/37) •Moderate: 19% (7/37)

•Severe: 35% (13/37)

Kushida Index ≥70

ODI ≥10 AND ESS

≥10

Morales,

2012

Group 4 Elderly

patients

(population study) with

and without

sleepiness


Male: 34%

BMI: 30.5 ±7.6 kg/m2

ESS: NR (30% ESS

>10) AHI: NR

92 •Optimal parameters set as one

that minimized total prediction

errors, computed as sum of false-positives and false-negative

predictions. 3-variables chosen:

Apnea symptoms, neck circumference, age

•Type I Polysomnography (Sandman, Embla)

AHI: sum of apneas

and hypopneas per

hour of sleep Hypopneas: ≥50%


with either a ≥3% oxygen or EEG

arousals


No OSA: 73% (70/92)

OSA (AHI ≥5 & ESS >10): 27%

(22/92) •Mild (AHI 5-15 & ESS >10):

32% (7/22)

•Moderate (AHI 15-30 & ESS >10): 23% (5/22)

•Severe (AHI ≥30 & ESS >10):

45% (10/22)

Rule ≥0.676 AHI

≥30/hr &

ESS >10

Su, 2012 Group 3 Consecutive

patients

with

suspected

OSA

Age: 48.3 ±11.9

years

Male:77%

BMI: 24.8 ±3.1

kg/m2 ESS: 10.1 ±6.4

AHI: NR

144 •Multiclass Mahalanobis-Taguchi

(MMTS) based anthropometric

information and questionnaire

data to predict OSA (6 variables:

age, weight, SBP, DBP, DI3, DI4)

• Type 1 polysomnogram

RDI: “Number of events

per

hour of sleep”

Hypopnea: NR

OSA: RDI ≥5/hr

No OSA (RDI <5): 28% (8/29)

OSA (RDI ≥5): 72% (21/29)

•Mild (RDI 5-15): 29% (6/21)


(9/21) •Severe (RDI ≥30): 29% (6/21)

Various:

AHI ≥5/hr

AHI ≥15/hr

AHI ≥30/hr

Various:

AHI ≥5/hr

AHI

≥15/hr

AHI ≥30/hr

Kolotkin,

2012

Group 3 Bariatric

surgery

candidates

Age: 41.6 ±10.4

years

Male:16% BMI:46.8 ±7.5 kg/m2

ESS: NR

AHI: NR

310 • Dixon prediction model

developed previously to predict

clinically suspected OSA in bariatric surgery candidates. (6

variables: BMI ≥45 kg/m2, age

≥38 years, HgA1C ≥6%, insulin level ≥28 μU/mL, male gender,

neck circumference ≥43 cm)

• Kolotkin alternative prediction

model developed and validated a prediction model to predict OSA

in bariatric surgery candidates.

(10 variables: neck

AHI: sum of apneas

and hypopneas per

hour of sleep Hypopneas: “A

reduction” in nasal

flow with a >4% oxygen desaturation

OSA: AHI ≥5/hr

No OSA (AHI <5): 19% (58/310)

OSA (AHI ≥5): 81% (252/310)

•Mild (RDI 5-15): 47% (115/252) •Moderate (RDI 15-30): 26%

(65/252)

•Severe (RDI ≥30): 29% (72/252)

Dixon Model

Various:

Cut-points between 0

and 6 points

Alternate

Model

Various: Cut-points

between 0 and 10 points

Various:

AHI

≥15/hr AHI

≥30/hr


106

circumference ≥40.75 cm, SBP

≥123.5, waist/hip ratio≥0.956, waist ≥134.4 cm, glucose, ≥96.5

loud snoring, age ≥41.5 years,

frequent snoring, BMI ≥45.17 kg/m2, male gender))

• Type III Sleep Study (Embletta portable system without EEG)

Khoo, 2011 Group 4 Consecutive

patients referred to a

sleep clinic

Age: 45.5 ±13.5

years Male:81%

BMI: 29.6 ±5.7

kg/m2

ESS: NR

AHI: 40.8 ±29.5/hr

52 Koo Model (developed and

validated in current study): age, male gender, neck circumference,

frequent awakenings with

unrefreshing sleep

Type I Polysomnography

(Compumedics E Series)

Flemons Index (previously

validated 4-variable model to predict clinically suspected OSA):

neck circumference, HTN, habitual

snoring and gasping/ choking

AHI: sum of apneas

and hypopneas per hour of sleep

Hypopneas: ≥20%

reduction in nasal flow

with a >3% oxygen

desaturation

OSA: AHI ≥20/hr

No OSA (AHI <20): 34% (18/52)

OSA (AHI ≥20): 65% (34/52)

Koo Model:

0.6

Flemons

Index: 17

AHI

≥20/hr

Sun, 2011 Group 3 Suspected

OSA

Age: 43.4 ±12.7

years Male: 76%

BMI: NR (20% BMI

>25 kg/m2) ESS: NR (39% ESS

>10)

AHI: NR

110 •Genetic algorithm was used to

build the five best models based on questions taken from the

Berlin Questionnaire, Rome

Questionnaire, ESS and BASH’IM score

• “Polysomnography test”

AHI: NR


No OSA (AHI <5):23% (25/110)

OSA (AHI ≥5): 77% (85/110) •Mild (AHI 5-15): 38% (32/85)


(27/85) •Severe (AHI ≥30): 31% (26/85)

AHI ≥15/hr

AHI

≥15/hr

* Abbreviations: AHI (apnea-hypopnea index), BMI (body mass index), CABG (coronary artery bypass graft), CAD (coronary artery disease), COPD (chronic obstructive pulmonary disease), CPAP

(continuous positive airway pressure), DM (diabetes mellitus), EEG (electroencephalogram), ESS (Epworth sleepiness scale), hr (hour), IQR (interquartile range), MI (myocardial infarction), N (number),

NR (not reported), OSA (obstructive sleep apnea), OSAS (obstructive sleep apnea syndrome), mod (moderate), PSG (polysomnogram), RDI (respiratory disturbance index), RERA (respiratory effort related

arousal), SDB (sleep disordered breathing)


107

Table 31 - AHRQ Question 1C – Diagnostic Accuracy of OSA Clinical Prediction Rule Diagnostic Studies


Prevalence


value


Probability

Neg

Posttest

Probability

Jauhar,

2012

71 •Rule: ≥71

•PSG: ODI ≥10 AND

ESS ≥10

0.521 Patients with

suspected OSA

25 12 10 24 0.001 0.676 0.706 0.714 0.667 2.297 0.459 0.690 NR 0.714 0.333

Moreales,

2012

92 •Rule: ≥0.676

•PSG: AHI ≥30 AND

ESS >10

0.109 Elderly subjects

with and without

sleepiness

9 1 29 53 <0.001 0.900 0.646 0.237 0.981 2.545 0.155 0.674 0.774 0.237 0.019

Su, 2012 144 •Rule: AHI ≥5/hr

•PSG: AHI ≥5/hr

0.724 Patients with

suspected OSA

. . . . . . . . . . . 0.844 . . .

Kolotkin,

2012

310 •Dixon Rule: ≥2 criteria •PSG: AHI ≥15/hr

0.442 Bariatric surgery candidates

103 34 74 99 <0.001 0.752 0.572 0.582 0.744 1.758 0.434 0.652 NR 0.582 0.256

310

•Dixon Rule: ≥3 criteria



candidates

71 66 31 142 <0.001 0.518 0.821 0.696 0.683 2.892 0.587 0.687 NR 0.696 0.317

310 •Dixon Rule: ≥2 criteria •PSG: AHI ≥30/hr

0.232 Bariatric surgery candidates

60 12 117 121 <0.001 0.833 0.508 0.339 0.910 1.695 0.328 0.584 NR 0.339 0.090

310 •Dixon Rule: ≥3 criteria



candidates

46 26 56 182 <0.001 0.639 0.765 0.451 0.875 2.715 0.472 0.735 NR 0.451 0.125

155 •Kolotkin Rule: ≥5 criteria


NR Bariatric surgery candidates

. . . . . 0.761 0.716 . . . . . 0.780 . .

155 •Kolotkin Rule: ≥5 criteria


NR Bariatric surgery candidates

. . . . . 0.839 0.597 . . . . . NR . .

Khoo, 2011 52 •Koo Model: 0.6 •PSG: AHI ≥20/hr


13 21 3 17 0.073 0.382 0.850 0.813 0.447 2.549 0.727 0.577 0.690 0.828 0.579

52 •Flemons Index: 17


0.654 Sleep clinic

patients

25 7 11 9 0.079 0.781 0.450 0.694 0.563 1.420 0.486 0.654 0.642 0.694 0.438

Sun, 2011 43 •Rule: AHI ≥15/hr •PSG: AHI ≥15/hr

NR Patients with suspected OSA

. . . . . 0.818 0.952 0.947 0.833 . . 0.884 . . .





108

Table 32 - AHRQ Question 2 – Phased testing compared with full testing alone

Study Search

Strategy

Sample Demographics N Phased Testing/Validation OSA Definition OSA Prevalence Prediction Rule PSG

Cut-Point(s)

Morales,

2012

Group 4 Elderly patients

(population

study) with and without

sleepiness


BMI: 30.5 ±7.6 kg/m2

ESS: NR (30% ESS >10)

AHI: NR

92 •Two-stage algorithm (3 parameters): 1) MAP lower bound

below which sleep apnea could be

excluded; 2) MAP upper bound above which study participants can

be assessed to have OSA; and 3)

home study AHI cut-points (to be used in study participants with

intermediate MAP values) above

which study participants can be assessed to have OSA.

•Phase testing: 1. MAPI (multivariate apnea

prediction instrument) and/or apnea

symptoms and clinical findings 2. Portable Type IV sleep study

based on prior test results (if

“intermediate” OSA probability

•Optimal parameters set as one that minimized total prediction errors,

computed as sum of false-positives

and false-negative predictions. 3-variables chosen: Apnea symptoms,

neck circumference, age

•Validation: Type I

Polysomnography (Sandman, Embla)

AHI: sum of apneas and hypopneas per hour of

sleep


with either a ≥3%

oxygen or EEG arousals OSA: AHI ≥30/hr and

ESS >10

No OSA: 73% (70/92) OSA (AHI ≥5 & ESS >10): 27%

(22/92)

•Mild (AHI 5-15 & ESS >10): 32% (7/22)

•Moderate (AHI 15-30 & ESS >10):

23% (5/22) •Severe (AHI ≥30 & ESS >10): 45%

(10/22)

Rule ≥0.676 AHI ≥30/hr & ESS >10




breathing)


109

Table 33 -AHRQ Question 2 – Phased testing compared with full testing alone


Prevalence


value


Probability

Neg

Posttest

Probability

Morales, 2012 92 •PSG: AHI ≥30/hr & ESS >10

•1st Stage prediction model (apnea

symptoms, neck circumference, age,

gender): Lower bound <0.5; Upper

Bound >0.80

•2nd Stage: Type IV sleep study AHI

>25/hr


with and without

sleepiness

10 0 21 61 <0.001 0.952 0.747 0.323 1.00 3.905 0.064 0.772 0.850 0.323 0.005

92 •PSG: AHI ≥30/hr & ESS >10

•1st Stage prediction model (MAPI):

Lower bound <0.4; Upper Bound

>0.90

•2nd Stage: Type IV sleep study AHI

>15/hr


with and without

sleepiness

9 1 20 62 <0.001 0.900 0.756 0.310 0.984 3.690 0.132 0.772 0.833 0.310 0.016





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