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An experience with the Patient-Reported OutcomesMeasurement Information System: Pros and cons

and unanswered questionsTerry A. Badger, PhD, RN, PMHCNS-BC, FAANa,

Margaret Heitkemper, PhD, RN, FAANb,*, Kathryn A. Lee, PhD, RN, FAAN, CBSMc,Deborah Watkins Bruner, PhD, RN, FAANd

aDivision of Community and Health Systems Science, College of Nursing, Department of Psychiatry, Tucson, AZbDepartment of Biobehavioral Nursing and Health Systems, University of Washington, Seattle, WA

cDepartment of Family Health Care Nursing, University of California, San Francisco, CAdEmory University, Atlanta, GA

a r t i c l e i n f o

Article history:Received 11 February 2014Revised 17 June 2014Accepted 30 June 2014Available online 10 July 2014

Keywords:Patient-Reported OutcomesMeasurement InformationSystem

Irritable bowelPainFatigueSexual dysfunctionSpanish translationDepressionSymptoms

* Corresponding author: Margaret Heitkempe357266, Seattle, WA 98195-7266.

E-mail address: heit@uw.edu (M. Heitkem

0029-6554/$ - see front matter � 2014 Elsevihttp://dx.doi.org/10.1016/j.outlook.2014.06.00

a b s t r a c t

The goal of the Patient-Reported Outcomes Measurement Information System(PROMIS) is to create efficient, reliable, and valid assessments of adult and childhealth. The nursing science literature in which PROMIS measures are used israpidly expanding. Investigators have been encouraged to consider the integra-tion of PROMIS measures into both descriptive studies and clinical trials. Doingthis has created opportunities and challenges for investigators. This articlehighlights three projects to show the perspectives of nurse scientists who incor-porated PROMIS measures into their research. The first project describes advan-tages of PROMIS to allow for comparisons of a study population with a nationalsample and to compliment legacymeasures. The second project examines issuesin the translation of tools for region-specific Hispanic populations. The thirdproject provides a perspective on the use of PROMIS measures to capture cancer-related fatigue and to develop new components of a sexual function scale. Asindicated by these three examples, nurse scientists can contribute an importantrole inmoving the PROMIS initiative forward. Results from these types of projectsalsomove symptom science forward within amore interdisciplinary approach tocommon measures of interest.

Cite this article: Badger, T. A., Heitkemper, M., Lee, K. A., & Bruner, D. W. (2014, OCTOBER). An experience

with the Patient-Reported Outcomes Measurement Information System: Pros and cons and unanswered

questions. Nursing Outlook, 62(5), 332-338. http://dx.doi.org/10.1016/j.outlook.2014.06.009.

Background

This article provides information shared at the October2013 Council for the Advancement of Nursing ScienceConference Innovative Approaches to Symptom

r, Department of Biobeha

per).

er Inc. All rights reserved9

Science: Measurement and Analysis. The authors ofthis article are investigators who incorporated eitherone or more Patient-Reported Outcomes MeasurementInformation System (PROMIS) tools into their NationalInstitutes of Healthefunded research projects. Ab-stracts of these studies are presented in Tables 1 and 2.

vioral Nursing and Health Systems, University of Washington, Box

.

Table 1 e Abstract of a Study in Which PROMIS Pain Measures Were Used in Women with Irritable BowelSyndrome

A Comparison of PROMIS Pain Measures with Legacy Measures in Women with Irritable Bowel Syndrome (IBS)Introduction: Patients with IBS are more vigilant to pain-associated stimuli. The purpose of this pilot study was 1) tocompare womenwith IBS to a national data base on the PROMIS pain behavioral and interferencemeasures; 2) to determinethe relationship of PROMIS pain behaviors and interferencesmeasureswith legacymeasures of pain and quality of life (QOL)and pain sensitivity using a test of central pain modulation (CPM).Methods: Women (n¼20) between the ages of 18 and 45 with a medical diagnosis of IBS (Rome III diagnosis) were comparedto healthy controls (HC) women recruited from the community. Women completed the PROMIS-Pain Behavior and thePROMIS-Pain Interference short forms (8 items each) as well as a 14-day symptom diary. On the diary GI, psychologicaldistress, and abdominal discomfort symptoms were rated on a 0-4 scale based on severity (none, mild, moderate, severe,very severe). Diary data were collapsed into percent of days with moderate-very severe report of symptoms and lifeinterference. Pain Behaviorwasmeasured by the Pain Behavior short formwhich asks about commonpain behaviors that canbe observed, behaviors associated with pain severity, verbal reports of pain (rated from 1 ‘not at all’ to 5 ‘very much’), and onesocial item. Internal consistency for this study was r ¼ .89. Pain Interference was measured by the PROMIS-Pain InterferenceShort Form which asks about the consequences of pain on five relevant aspects including: social, cognitive, emotional,physical and recreational activities over the past 5 days. Internal consistency for this study was r ¼ .91. The CPM was testedwith a counter-irritation approach in a laboratory between 8 and 10 am on a follicular phase day. The study protocol andfindings are described in further detail in (Jarrett et al., 2014).Results: There were positive associations among PROMIS painmeasures and legacymeasures of abdominal pain (.416-.430).There were significant inverse relationships with the legacy QOL measure. During the CPM testing, there was a positiverelationship between baseline pain sensitivity and PROMIS pain interference measure.Implications: The PROMIS pain measures allow for characterization of women with IBS in comparison to a nationalpopulation. In addition, there is good correlation with legacy measures in this population.

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PROMIS Advantages

The use of the PROMIS measures by biobehavioralnursing scientists who are focused on understandingthe biological underpinnings of symptom reports pro-vides several advantages. A key advantage is the abilityto compare symptoms reported by one’s sample to anational data base (one of the intended purposes of thePROMIS development). Project 1, “The Pathways toAbdominal Pain,” provides an example of this advan-tage (Table 1).

Project 1 Background

Project 1 was an American Recovery and ReinvestmentAct of 2009-funded project with the aim of collectingdata in children and adults with irritable bowel

Table 2 e Abstract of a Study in Which PROMIS Measur

Interventions to Improve Quality of Life for Latinas with BreastPurpose: To test the effectiveness of two culturally sensitive, ex(psychological, physical, social and spiritual well-being) for LaDesign: This study is a randomized clinical trial design with mand 2- and 4-months post intervention. Latinas and their suppdelivered interpersonal counseling intervention or a health edmeasurements are conducted by telephone. This study is conprovided in either English or Spanish.Sample: Thus far, the sample includes 72 Latinas, with ameanhousehold incomes of � $30K year. Sixty-seven percent of theunemployed but seeking and 42%were disabled/unable to worunderwent breast reconstruction. Most have public insuranceof thewomen had stage 3 or 4 breast cancer. Themajority (80%)groups). The supportive partnerswere primarily Latino/a, and hOf note, 64% of the supportive partners were female relatives.Results: (relevant to PROMIS): PROMIS instruments had good rquestioned.

syndrome (IBS). IBS is a common functional gastroin-testinal (GI) disorder that affects 10% to 17% of theAmerican population. Abdominal discomfort/painrelieved by an alteration in bowel function (e.g., diar-rhea, constipation, or mixed) is a key diagnostic crite-rion (part of the Rome III guidelines) (Drossman et al.,2006). Previous studies by the investigative team used“legacy” measures including a retrospective measureof GI distress and a daily diary to assess 26 symptoms(e.g., gastrointestinal, somatic, and psychologicaldistress) on a scale of “0” (i.e., not present) to “4” (i.e.,extreme) (Heitkemper et al., 2011; Cain et al., 2008).

Abdominal Pain/Discomfort Symptom Measures

When the investigators began this project, PROMISmeasures were “new” and offered the added advantageof comparing reports of pain in this population with

es Were Used for Latinas with Breast Cancer

Cancerpedient psychosocial interventions to improve quality of lifetinas with breast cancer and their supportive partners.easures obtained at baseline, after the 8-week intervention,ortive partners are randomly assigned to either a telephoneucation intervention. All intervention sessions andducted in the southwestern US and all written materials are

age of 49 years, 52%weremarried/partneredwith 80% havingLatinas had � High School education and 32% were

k. In this sample, 42% had completemastectomy and only 2%which does not allow for breast reconstruction. Forty percentdid not participate in any supportive treatment (e.g., supportave similar incomes, educational and employment histories.

eliability (a�.92), but some Spanish translations were

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that of a national sample. For example, abdominalpain/discomfort is a core symptom specified in theRome III criteria for IBS. Numerous cross-sectionalstudies performed by us and others have validatedthat daily reports of abdominal pain/discomfort arehigher in persons with IBS when compared with age-and gender-matched healthy controls. In addition,several older survey studies showed that patients withIBS report more discomfort and disability whencompared with patients with other chronic illnessesincluding diabetes and inflammatory bowel disease(Haagsma, Siersema, De Wit, & Havelaar, 2010; Leonget al., 2003; Tkalci�c, Hauser, & Stimac, 2010; Lea &Whorwell, 2001; Gralnek, Hays, Kilbourne, Naliboff, &Mayer, 2000). However, for the most part, thesestudies used disparate measures of abdominal pain tocapture symptom intensity or frequency as well asquality of life (QOL) across populations. IncorporatingPROMIS measures into Project 1 at the onset providedthe opportunity to compare the pain experience in oursample with the pain experience in a national sample.The short forms of pain interference and behaviorswere used in combination with legacy measures.

Using the PROMIS website and manual for scoring,we determined that the IBS group had a PROMIS painbehavior score of 54.1 (standard deviation ¼ 8.2) and aPROMIS pain interference score of 56.8 (standard de-viation ¼ 7.7) relative to the population standard scoreof 50. Thus, as a group, our sample of IBS patients hadhigher pain behaviors and greater pain interferencecompared with the general population. In addition,there were positive correlations among PROMIS painbehavior and PROMIS pain interference measures withour legacy measures of daily diary abdominal pain andabdominal pain recall (r ¼ 0.430, r ¼ 0.485, respectively)and QOL (r ¼ �0.550).

Additional Issues to Consider from Experience withProject 1

One benefit of incorporating the PROMISmeasures intostudies of IBS patients is that it permits comparisons ofdifferent symptoms (e.g., pain and fatigue) with largercombined data sets. For example, the prevalence ofother visceral and somatic pain conditions includingfibromyalgia, chronic fatigue syndrome, interstitialcystitis, headache, and musculoskeletal pain arehigher in women with IBS compared with healthygender-matched controls (Mulak, Tache, & Larauche,2014; Nellesen et al., 2013). With multiple in-vestigators from a variety of laboratories incorporatingPROMIS measures for pain, sleep, sexual dysfunction,and fatigue, big data can emerge to answer suchquestions as, “Do patients with IBS plus comorbiditiesreport more fatigue, pain, or sexual dysfunction rela-tive to those who only report IBS?” Such informationcan be important to designing therapeutic trials that gobeyond a single symptom or condition. For example,the patient with IBS who reports high levels of sleepdisturbance may be more likely to benefit from the

incorporation of sleep hygiene. Whether data from thePROMIS measures can add to the information neededfor hypothesis development for exploration of rootcauses of symptom distress remains to be determined.

Can PROMIS measures replace legacy measuressuch as a daily diary? Similar to some other legacy tools(IBS Disease Questionnaire), which capture retrospec-tive symptom frequency and severity, the PROMISmeasures do not inform us about the temporal rela-tionship of the symptoms in the way daily diaries do(the primary legacy measure of our studies). Forexample, we know that GI symptoms for many womenwith IBS are exacerbated or amplified at specific timesduring themenstrual cycle (Heitkemper & Chang, 2009;Altman, Cain, Motzer, Jarrett, & Heitkemper, 2006).Similarly, poor sleep reported on a diary is related to anincrease in GI symptoms (also reported on a diary) thenext day (Jarrett, Heitkemper, Cain, Burr, & Hertig,2000). Quantitative information such as the timing ofsymptoms with respect to meals and stress would bebest provided by diaries or technology that allows forreal-time data collection.

Because only the short forms were used in thisproject, the issue of subject burden did not surface.However, the use of the composite tools with 46 or 57items, in addition to legacy tools, remains to be eval-uated for subject burden in this population. Of note isthat the GI symptom PROMIS measure is currently indevelopment, and the PROMIS website contains cur-rent information on these and other tools underdevelopment (prosettastone.org).

In summary, our initial belief is that comparisonswith a national database is important to provideadequate description of the sample and to eventualdata sharing.

PROMIS Challenges

In Project 2, the nurse scientist was involved in testingthe effectiveness of two culturally sensitive, expedientpsychosocial interventions to improve QOL for Latinaswith breast cancer and their supportive partners.Although Spanish language versions of PROMIS mea-sures are available and widely used, there are chal-lenges for nurse scientists to consider. This challengeis highlighted in Project 2.

Project 2 Background

Project 2 involved a sample of Latinas in the South-western United States. They were enrolled in a study oflow-income women with breast cancer and their sup-portive partners. Most of the Latinas who participatedin this study had families that had lived in the South-western United States for several generations, and themajority had cultural ties with the Sonora region ofMexico. These ties influenced the ability of the

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participants to understand some translations of thePROMIS items. Table 2 provides an abstract of thestudy.

Depressive Symptoms and Quality of Life Measures

For several constructs (e.g., depression), legacy mea-sures were used in addition to the PROMIS measures.The rationale for the use of legacy measures for con-structs such as depression was to enable investigatorsto compare across their own studies because theselegacy tools had been used for prior studies. The ad-vantages of these types of comparisons have beenpreviously illustrated in Project 1.

Language Challenges

The major challenge encountered in Project 2 wasadopting the PROMIS Spanish language versions of thesymptom measures. The Spanish PROMIS instrumentswere developed using a universalist approach totranslation (nihpromis.org/measures/translation)danapproach in which one word is selected to be suitablefor all Spanish speakers across all regions within theUnited States. The instruments were translated/back-translated with approximately 4,000 U.S. Spanishspeakers (<10% of the sample were Hispanic) (Pilkoniset al., 2011).

The universalist approach to translation does notinclude region-specific language differences because itis thought to introduce bias and decrease standardi-zation (nihpromis.org/measures/translation), makingit more difficult to compare results across studies.However, Badger and her Project 2 team found thatsome universalist item translations did not capture theintent of the question or that items were exact trans-lations from English and thus not understood by thissample.

This experience raised the concern about consistentlinguistic and cultural equivalency across the PROMISitems. This concern may necessitate greater attention

Table 3 e Translations of PROMIS Measures: English, U

Anxiety PROMIS� English Version: I felt uneasy� Universalist Translation: Me sentı intranquilo/a� Region Specific Change: Inquieta (word used for uneasy in loc

Fatigue PROMIS� English Version: How much were you bothered by your fatigu� Universalist Translation: En que medida la molesto el agotam

Reads as: In what measure did it bother the fatigue on average?� Region Specific Change and Correction: En promedio que tant

In this example, “on average” was placed first.

Social Support PROMIS� English Version: I have someone who will listen to me when I� Universalist Translation: Tengo quien me escuche cuando nec

In this example, the phrase leaves out “someone” and “who”� Region Specific Change: Tengo quien a alguien me escuche cu

to determining tool validity in specific U.S. populations.This project employed bilingual bicultural data collec-tors who were all born and lived locally, with culturalties to Sonora, Mexico. Very quickly these data collec-tors began to question some of the item translations, asdid many participants who found some itemsconfusing. After pilot testing the instruments with 25dyads, it was clear that some changes were needed toensure cultural and linguistic equivalence for thisLatina sample. Data collectors were routinely inter-preting what a particular word or phrase meant forsome items, indicating that a wording change wasneeded to capture valid and reliable data.

The universalist translation was clear for a majorityof items; yet, some items were not culturally andlinguistically equivalent for this regional Latina popu-lation. Table 3 shows themodifications to several itemsfrom the Spanish PROMISmeasures that were requiredin order to establish adequate reliability and validity inthis study population.

Additional Issues to Consider from Experience withProject 2

An additional challenge to using the PROMIS with thislow-income population was the computer adaptivetesting (CAT) data collection method. With the CATmethodology, the subsequent question in the onlinesurvey will vary based on the participant’s response tothe prior question. Although the CAT system canreduce participant burden and does provide a precisemeasure using a battery of items, the issue of thesuitability of this method for all populations should becarefully evaluated. For example, in Project 2, staticmeasures were selected because of the participants’lack of access to computers and data collection bytelephone.

In summary, the PROMIS measures provided reliableand validmeasures, allowed for comparisons between aLatina sample of women with breast cancer and a

niversalist, and Region-Specific Change Items

al region)

e on average?iento en promedio?

o le molesto el agotamiento.

need to talkesito hablarIssue:

ando necesito hablar

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national sample, and were highly correlated with thelegacy measures used in Project 2. Based on the experi-ences with PROMIS measures in Project 2, nursing sci-entists moving forward should be encouraged toconsider using these measures in their research. Thisinitiative will allow for meaningful comparison acrossstudies on phenomena of interest and ultimately lead tobetter questions that can be answered with big datamerged frommany investigators. Although the Project 2research team made some regional-specific changes tothe Spanish measures in order to increase the partici-pant’s ability to respond without explanation that werelikely to introduce error, it should be noted that most ofthe Spanish measures performed quite well andrequired no changes.

Potential New Opportunities for Nurse ScientistsUsing PROMIS Measures

Understanding the pathophysiology and managementof symptoms in patients with chronic illness is acommon pursuit of nursing scientists and necessitatesthe use of valid and reliable instruments. Project 3 in-volves populations of cancer patients and the uniquesymptom experiences that have high potential forfuture programs of research for nursing scientists.

Project 3 Background

Cancer-related fatigue (CRF) is the most commoncancer-related symptom regardless of cancer site ortreatment. For the most part, CRF is unrelated to sleepand activity. Fatigue is also a common side effect ofother medical conditions including depression, heartdisease, and insomnia, which may also be present inthe person with cancer. CRF is difficult to assess andtreat because of its nonspecific nature and inconsistentmeasurement. In studies that ask only about thepresence or severity of self-reported CRF, the preva-lence is usually high (70%e99%) (Curt et al., 2000). Incontrast, the prevalence ismoderate to high (30%e70%)in studies requiring CRF to exceed a threshold ofseverity, duration, or functional impairment and evenlower (15%e30%) in studies that defined CRF as a syn-drome (Barsevick et al., 2013; Servaes, Prins, Verhagen,& Bleijenberg, 2002; Andrykowski, Donovan, Laronga,& Jacobsen, 2010).

Fatigue Measures

The PROMIS-Fatigue (PROMIS-F) measure was one of thefirst PROMIS scales to be developed. The intent was todevelop a tool that would standardize fatigue assess-ments across adult populations. The PROMIS-F wastestedusingcomparisonswithcommonvalidated legacymeasures including the Functional Assessment ofChronic Illness Therapy-Fatigue and the Medical Out-comes Short Form. The instruments were highly inter-correlated and performed equally well in detecting theobserved associations. PROMIS-F also showed good

precision in another study, with reliability greater than0.9 in both healthy control and clinic patient populations(Christodoulou, Schneider, Junghaenel, Broderick, &Stone, 2014). However, many investigators have builtprograms of research on validated legacy measures ofsymptoms like fatigue. Thus, the uptake of PROMIS-Fmeasures by researchers has not been widelyembraced. For example, in a recent systematic review of40 CRF instruments, none included the PROMIS-F. Inter-estingly, fiveof themost commonlyused instruments forCRF each had nearly identical psychometric properties(Seyidova-Khoshknabi, Davis, & Walsh, 2011).

Despite the lack of rapid incorporation into studiesof CRF, the PROMIS-F seems to hold promise forimproving the consistent measurement of CRF. Rec-ommendations from a 2010 Clinical Trials PlanningMeeting on CRF convened by the National CancerInstitute included support for the use of PROMIS-F. Themeeting goal was to examine issues, including mea-surement, to advance CRF science. Participantsincluded representatives of academia, communityoncology, government, the pharmaceutical industry,and patient advocates. Recommendations thatemerged from the meeting suggested that researchersadopt the PROMIS-F as the standard measure for CRF(Barsevick et al., 2013). However, it is important to notethat this recommendation was made without a singleclinical trial using PROMIS-F with the cancer popula-tion yet published. This suggests that further valida-tion of PROMIS measures, particularly within thecontext of CRF, would be welcomed among interdisci-plinary researchers.

Sexual Dysfunction Measures

In addition to fatigue, another common symptom thatlacks a common definition and metric is sexualdysfunction. Sexual dysfunction after cancer treat-ment ranges from 40% to 100% depending on the tumorsite and treatment as well as the metric used forassessment. It is a significant concern during the entiretreatment trajectory, from diagnosis through survi-vorship. The development of a comprehensive self-report tool to measure sexual dysfunction in thecancer population is important in order to captureunique difficulties that are relevant in this population,such as the effects of particular chemotherapeuticagents, antiandrogens, and surgeries. Unlike CRF,cancer-related sexual dysfunction has received lessattention in the literature, andmeasures are evenmorevariable and not as well developed or validated. Entireaspects of sexual function have no cancer-specificmetric. For example, oral sex, emerging as an impor-tant area of research to improve our understanding ofhuman papilloma virusepositive head and neck can-cers, is an area in need of developing and testing spe-cific common metrics.

The PROMIS-Sexual Function (SexFS) measureshave the potential to offer researchers and clinicians acomprehensive, reliable, and valid set of tools to

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measure self-reported sexual function and satisfactionamongmen andwomen livingwith cancer (Flynn et al.,2013). The internal consistency reliability (Cronbachalpha coefficients) formen andwomen range from 0.87to 0.95, and test-retest reliability interclass correlationcoefficients range from 0.71 to .0.87.

Unlike the PROMIS-F for fatigue, the PROMIS-SexFSoffers new and previously unavailable modules/do-mains, such as a measure of oral sexual engagementand satisfaction. However, aswith CRF, one challenge inadopting the PROMIS-SexFS measures is that there arecommonly used legacy instruments for specific aspectsof sexual function, such as the International Index ofErectile Function, which is considered a standard mea-sure in both research and clinical practice.

In summary, PROMIS measures in general andSexFX in particular may challenge established in-vestigators to abandon their use of standard legacyscales in favor of enhanced ability for comparisonsacross studies and populations. As these comparisonsbecome available and big data contain merged data forthese types of symptoms, this challenge may beattenuated. As scores are mapped from PROMIS-SexFSto these more familiar legacy instruments for com-parisons, it remains to be determined whether thePROMIS-SexFS is clinically relevant to the same degreeas the legacy tools.

Summary

As nursing scientists, the authors concur that it isimportant to support moving the PROMIS initiativeforward. The notion of having a common currencyregarding symptoms and symptom impact on QOL islaudable, but more work still needs to be done. Formost investigators, the use of PROMISmeasures will bedone in concert with the continued use of morefamiliar legacy tools and the incorporation of selectedrelevant short forms or composite tools. Amongnursing scientists, there are aspirations for a nationalsymptom database to be used by trainees and inter-disciplinary colleagues. The incorporation of thePROMISmeasures, along with other National Institutesof Health tool kits such as the Neuro-QOL, may be astep toward developing common data elements fornursing scientists. The ultimate goal is to enhance thetranslation of valid research data into clinical practiceand better outcomes, and the use of PROMIS measureswill continue to have advantages as well as challenges.

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