The Egyptian Rheumatologist (2014) xxx, xxx–xxx

Egyptian Society for Joint Diseases and Arthritis

The Egyptian Rheumatologist

www.rheumatology.eg.netwww.sciencedirect.com

ORIGINAL ARTICLE

Assessment of health-related quality

of life, anxiety and depression in patients

with early rheumatoid arthritis

* Corresponding author. Address: Rheumatology and Rehabilitation

Department, Faculty of Medicine, Sohag University, Sohag, Egypt.

Tel.: +20 1140202238.E-mail address: abualfadl71@yahoo.com (E.M. Abu Al-Fadl).

Peer review under responsibility of Egyptian Society for Joint Diseases

and Arthritis.

Production and hosting by Elsevier

1110-1164 � 2014 Production and hosting by Elsevier B.V. on behalf of Egyptian Society for Joint Diseases and Arthritis.

http://dx.doi.org/10.1016/j.ejr.2013.12.004

Please cite this article in press as: Abu Al-Fadl EM et al. Assessment of health-related quality of life, anxiety and deprespatients with early rheumatoid arthritis, The Egyptian Rheumatologist (2014), http://dx.doi.org/10.1016/j.ejr.2013.12.004

Esam Mohammed Abu Al-Fadla,*, Mohammed Ali Ismail

a,

Mohammed Thabit b, Yasser El-Serogy c

a Rheumatology and Rehabilitation Department, Sohag University, Egyptb Neurology and Psychiatry Department, Sohag University, Egyptc Psychiatry Department, Assiut University, Egypt

Received 19 November 2013; accepted 18 December 2013

KEYWORDS

Health-related quality of Life

(HRQoL);

Rheumatoid arthritis (RA);

Short-form SF-36;

Hamilton Anxiety Rating

Scale;

Disease activity score

(DAS28)

Abstract Aim of the work: To assess the effect of clinical manifestations, disease activity and med-

ications on health-related quality of life (HRQoL) among patients with early rheumatoid arthritis

(RA).

Patients and methods: Twenty-six early RA patients (mean age 43.31 ± 10.51 years, disease dura-

tion: 16.5 ± 5.2 months) diagnosed according to the 2010 RA classification criteria were recruited

from the outpatient clinic of the Rheumatology and Rehabilitation Department, Sohag University,

and 22 age and sex matched healthy persons participated in a case control study. Demographic data

were taken from all participants in the study. The 36-item short-form health survey (SF-36) andHam-

iltonAnxietyRating Scale (HAM-A)were assessed asmeasures ofHRQoLandpsychiatric comorbid-

ity for both patients and controls. Disease activity in RA was assessed using the disease activity score

(DAS28). Scoring algorithmswere applied to produce the physical andmental component scores (PCS

andMCS).

Results: There was statistically significant difference in the total SF36 score, anxiety and depression

scores of HAM-A scale between patients and controls. The PCS showed the highest significant

difference (p< 0.0001), followed by SF36 (p= 0.01) andMCS (p= 0.024). Therewere no significant

differences according to the age, gender, occupation or level of education of the patients. Anxiety and

depression scores significantly correlatedwith thebodily pain andDAS28 scores and inverselywith the

sion in

2 E.M. Abu Al-Fadl et al.

Please cite this article in press as: Apatients with early rheumatoid arth

PCS and MCS. The DAS28 strongly negatively correlated with the PCS and MCS.

Conclusion: Rheumatoid arthritis has a major impact on many areas of an individual’s life and

tends to have a profound impact on the health-related quality of life.

� 2014 Production and hosting by Elsevier B.V. on behalf of Egyptian Society for Joint Diseases and

Arthritis.

1. Introduction

Rheumatoid arthritis (RA) is a chronic disabling multisystemautoimmune disease. It can lead to serious consequencesregarding functional abilities of patients. The physical disabil-ity caused by RA is usually evident at clinical level; however,

the psychological and social morbidities very easily evade theeyes of the clinician [1]. Health-related quality of life (HRQoL)questionnaires for patients are usually used to numerically

quantify the effect of disease morbidity on patient’s dailyliving.

HRQoL is important for measuring the impact of the dis-

ease, and for evaluating the effects and cost-effectiveness ofthe treatment. Some studies have assessed the HRQoL in pa-tients with RA and its improvement with early treatment [1–3]. The medical outcome study with 36-item short-form (SF-

36) is one of the widely used tools that evaluates HRQoLdue to an underlying illness [4].

Monitoring of people’s health at the national level has tra-

ditionally focused on morbidity and mortality measures,reportable infectious diseases, chronic conditions, and behav-ioural risk factors. However, these measures do not take in

consideration the HRQoL which provides a broader view ofdaily living activity and subjective well being [5,6].

Quality of life is a multi-dimensional concept which is used

to describe the individual’s perceptions, satisfaction, and eval-uation of different areas of their own lives, such as physicalhealth and functioning, psychological and emotional wellbeing, social roles and relationships. The complex, subjective,

and dynamic nature of the concept presents methodologicalchallenges to its measurement and interpretation [7].

There are no studies from this region assessing the HRQoL

in patients with early RA. The aim of our study was to assessthe effect of clinical manifestations, disease activity and medi-cations on HRQoL among patients with early RA.

2. Patients and methods

Twenty-six early RA patients (8 males and 18 females; mean

age of 43.31 ± 10.51, [range 23–60] years) diagnosed accord-ing to the American college of Rheumatology (ACR)/Euro-pean League against rheumatism (EULAR) 2010 RA

classification criteria [8] were recruited from the outpatientclinic of the Rheumatology and Rehabilitation Department,Sohag University and 22 age and sex matched healthy persons(4 males and 18 females; mean age of 39.64 ± 9.01 [range 21–

60] years) participated in a case-control study. Patients hadearly RA with disease duration of 16.5 ± 5.2 months (rangingfrom 3 months up to two years). All patients were >18 years

and gave informed written consent before inclusion in thestudy. This study was approved by the local ethics committeeof Sohag Faculty of Medicine.

bu Al-Fadl EM et al. Assessmritis, The Egyptian Rheumato

Patients who suffer past or current history of chronicinflammatory diseases (e.g. gout, reactive arthritis, or psoriatic

arthritis), other autoimmune rheumatic diseases (e.g. systemiclupus erythematosus, mixed connective tissue disease, sclero-derma, or polymyositis), neuropsychiatric disorders (e.g. fibro-

myalgia) and disease duration of more than 2 years wereexcluded from the study.

Demographic data (age, sex, job, marital state and educa-

tion) were taken from all participants in the study. Theshort-form SF-36, and Hamilton Anxiety Rating Scale(HAM-A) were assessed as measures of HRQoL and psychiat-ric co-morbidity for both patients and controls respectively.

Disease activity in RA patients was assessed using the diseaseactivity score in 28 joints (DAS28) which included an assess-ment of the visual analogue scale (VAS) for pain, number of

tender joints (Notj), number of swollen joints (Nosj) and theerythrocyte sedimentation rate (ESR). Patients with DAS28score higher than 5.1 were considered to have high disease

activity, whereas a DAS28 below 3.2 indicates low diseaseactivity. A patient is considered to be in remission if they havea DAS28 lower than 2.6. Items and scales of SF-36 question-naire [9] were constructed using the Likert method of sum-

mated ratings. Answers to each question are scored, thenthese scores were summed to produce raw scale scores for eachhealth concept which were then transformed to a 0–100 scale.

Scoring algorithms can then be applied to produce the PhysicalComponent Score (PCS) and Mental Component Score(MCS).

The 14 items’ HAM-A was scored from 0 to 4 (no to verysevere or grossly disabling anxiety) on each item of the scale.The total anxiety score range from 0 to 56. The seven psychic

anxiety items elicit psychic anxiety score that ranges from 0 to28. The remaining seven items yield somatic anxiety score thatalso ranges from 0 to 28. Patients having scores ranging from15 to 28 were considered to have mild anxiety, those who have

score range from 29 to 42 were considered to have moderateanxiety, and those who have scores >42 were considered tohave severe anxiety [10–11].

Statistical analysis: Data were analysed and expressed in ta-bles and figures as mean values ± standard deviations (SD).Student’s t-test was used to compare differences between RA

and controls. Pearson correlation test was used to study corre-lation between different quantitative variables with eachgroup. Values were considered significant when p-values were

60.05. IBM-SPSS program (version 19) was used for statisticalanalyses.

3. Results

Patients and controls were age and sex matched, no significantstatistical difference was found (t= 1.28; p = 0.21, andx2 = 1.01; p = 0.32). All patients had early RA with mean

disease duration of 16.5 ± 5.2 (range 6–24) months.

ent of health-related quality of life, anxiety and depression inlogist (2014), http://dx.doi.org/10.1016/j.ejr.2013.12.004

Table 2 Difference in quality of life scores according to SF 36,

depression and anxiety between rheumatoid arthritis (RA)

patients and controls.

Scores mean ± SD Patients Controls P-Value

Physical health 42.35 18.35 64.19 20.48 <0.0001

Physical functioning 62.12 23.46 79.32 18.15 0.007

Role physical 42.31 37.26 63.64 37.58 0.05

Bodily pain 66.5 27.0 34.5 20.5 0.002

General health 31.92 10.78 62.09 14.58 0.000

Mental health 44.01 20.38 57.88 20.77 0.024

Vitality 34.42 18.18 52.27 23.23 0.005

Social functioning 51.92 27.316 67.682 23.05 0.038

Role emotional 52.56 42.35 49.98 39.51 0.829

Mental health 49.23 15.99 57.27 20.67 NS

TOTAL SF36 score 45.69 20.84 62.01 21.06 0.01

Depression 16.8 7.5 4.05 4.17 0.001

Anxiety 9.35 5.477 5.82 4.895 0.024

SF-36, 36-item short-form.

Assessment of health-related quality of life, anxiety and depression 3

Demographic and clinical characteristics as well as the medica-tions received by the RA patients are presented in Table 1. Thecontrols were of comparable education level to the patients;

6(27.2%) were non-educated, 5(22.7%) achieved primary edu-cation, 4(18%) secondary education and 7(31.8%) highly edu-cated. However, there were much more employed controls

(86%) and 2 were workers and only one was a housewife.There was statistically significant difference between total

SF36 score, anxiety and depression scores of HAM-A scale be-

tween patients and controls (Table 2). Moreover, all SF36 sub-scales were significantly different between both groups(Table 2).

The significant differences between patients and controls in

all PCS, MCS, total SF-36, depression and anxiety scores werenot related to the sex of the patient (F = 0.67; p = 0.42). Also,there was no statistically significant difference between male

and female patients regarding the VAS, Nosj, Notj, ESR andDAS28.

Regarding the effect of occupation on HRQoL and psychi-

atric scales, there was no statistically significant difference be-tween employees and housewives in physical functioning,bodily pain, PCS, MCS, total SF-36, depression and anxiety

scores (F= 0.006, 0.18, 0.63, 0.56, 0.59, 0.102 and 0.302,respectively; p= 0.94, 0.68, 0.43, 0.46, 0.45, 0.75 and 0.59,

Table 1 Demographic and clinical characteristics as well as

the medications received by the rheumatoid arthritis (RA)

patients.

Feature RA patients (n= 26)

Mean ± SD

Age (years) 43.31 ± 10.51

Disease duration (months) 16.5 ± 5.2

Gender F/M 18/8

VAS 8.31 ± 1.85

Notj 4.23 ± 3.42

Nosj 9.19 ± 6.48

ESR (mm/1st hour) 50.31 ± 20.09

DAS-28 4.61 ± 1.098

Occupation No. (%)

Housewives 12 (46.2)

Workers 2 (7.7)

Employees 12 (46.2)

Education

Non-educated 8 (30.8)

Primary educated 3 (11.5)

Secondary educated 7 (26.9)

Highly educated 8 (30.8)

Type of treatment

Not any 2 (7.7)

MTX only 1 (3.8)

MTX+ antimalarial 5 (19.2)

MTX+ SSZ 1 (3.8)

Lef. only 7 (26.9)

Antimalarials only 2 (7.7)

Lef + antimalarial 4 (15.4)

Lef +MTX 4 (15.4)

VAS, visual analogue scale; Notj, number of tender joints; Nosj,

number of swollen joints; ESR, erythrocyte sedimentation rate;

DAS28, disease activity score in 28 joints; MTX, methotrexate;

SSZ, sulfasalazine; Lef, leflunomide.

Please cite this article in press as: Abu Al-Fadl EM et al. Assessmpatients with early rheumatoid arthritis, The Egyptian Rheumato

respectively); although being worse in housewives showing alower physical function and higher bodily pain. According tothe education level, highly educated patients had a lower qual-

ity of life (QoL) than non-educated patients in the domains ofphysical function, the PCS and the MCS although they showedsignificantly less bodily pain than the non-educated.

The PCS has the highest significant difference betweencases and controls (p= 0.0001), followed by SF36(p= 0.01), then MCS (p = 0.024), but non-significant differ-ences regarding bodily pain, physical functioning, depression

and anxiety (p = 0.399, 0.485, 0.209 and 0.585, respectively).The age of the patient has nothing to do with HRQoL or psy-chiatric scales, as there was no significant difference between

young (<45 years), and old (>45 years) patients regardingboth HRQoL and psychiatric scores.

The prevalence of anxiety in the present study was 26.9%.

Patients with lower level of education had much higher level ofanxiety than highly educated ones.

There was significant negative correlation between anxiety

score at one side and PCS and MCS on the other side(r= �0.38; p< 0.05, and r = �0.34; p< 0.05 respectively).The same applies for depression score and PCS and MCS(r= �0.45; p < 0.05, and r= �0.43; p < 0.05, respectively).

There was significant correlation between both anxiety anddepression scores with the bodily pain and DAS28 scores (anx-iety; r= 0.56; p < 0.01, and r= 0.47; p < 0.05, and depres-

sion; r= 0.63; p < 0.001, and r= 0.55; p < 0.01,respectively) (Fig. 1). Finally, there was a strongly negativecorrelation between DAS28 and both PCS and MCS

(r= �0.89; p < 0.001, and r = �0.9; p < 0.001, respectively)(Fig. 2).

4. Discussion

Rheumatoid Arthritis is a chronic inflammatory disease of un-known aetiology, with an unpredictable course and prognosis.

Thus, it is not surprising that many patients with RA experi-ence anxiety and helplessness [12]. The intensity of the diseasevaries and the individual has to learn to live with pain and dis-abilities to a greater or lesser extent as part of his or her life. It

ent of health-related quality of life, anxiety and depression inlogist (2014), http://dx.doi.org/10.1016/j.ejr.2013.12.004

Figure 1 Correlation of the disease activity score (DAS28) with the (a) depression and (b) anxiety scores in early rheumatoid arthritis

patients.

Figure 2 Correlation of the disease activity score (DAS28) with the health-related quality of life (HRQoL) scores; (a) physical health, (b)

mental health and (c) the total short form 36 (SF36) score in early rheumatoid arthritis patients.

4 E.M. Abu Al-Fadl et al.

is therefore important to measure health status as well as other

non-medical aspects of life such as social and emotional func-tioning and family and peer relationships from the patient’spoint of view [13].

Five dimensions are recommended as a minimum standardfor measuring health: physical health, mental health, everydayfunctioning in social and role activities and general perceptions

of wellbeing [14]. The World Health Organisation (WHO) de-fines QoL as an individual’s perception of their position in lifein the context of the culture and value systems in which theylive and in relation to their goals, expectations, standards

and concerns [15]. Quality of life can be divided into health-re-lated (with physical, psychological, social, and spiritual subdo-mains) and non-health related (with personal, social

interaction, societal, and environmental subdomains). Theobjectives of this study were to determine HRQoL and psycho-logical distress in patients with early RA and assess the effect

of clinical manifestations, disease activity and medications.In our study we found that HRQoL scores significantly de-

creased in patients compared to controls, they are decreased in

all domains of SF 36. The mean PCS and MCS were signifi-cantly lower in patients than in controls. These results werein agreement with the study of West and Jonsson [16], whichconcluded that RA has negative impacts on patients’ physical,

Please cite this article in press as: Abu Al-Fadl EM et al. Assessmpatients with early rheumatoid arthritis, The Egyptian Rheumato

emotional and social functioning early in the disease measured

by the SF-36.In our study there were significant difference in the SF-36

role physical (RP) and social functioning (SF) subscales ob-

served in patients compared to healthy controls, this is consis-tent with the results of Benitha and Tikly [17] but in contrastwith an Italian study of Rinaldi et al. [18] that showed no dif-

ference in the SF-36 RP and SF subscales between patients andcontrols.

As regards the general health (GH) subscale, it was signif-icantly affected, this is in contrast to Thyberg et al. [19] where

no affection of the GH was detected. Kojima et al. [20] foundthat some patients who had a poor physical status could main-tain a good mental QoL despite pain, fatigue, psychological

distress, and/or low social support. In the current study itwas found that physical health is of the most affected domainsof SF-36 and this is consistent with Salaffi et al. [4]. The bodily

pain (BP) is an important factor in determining the QoL in theearly course of the disease [21]. In our study there is highly sig-nificant increase in BP in patients than in controls which affect

other aspects in their life such as the social aspect and limita-tion of their physical activity.

In this study we tried to determine other factors affectingHRQoL besides RA affection as regards age, sex, level of

ent of health-related quality of life, anxiety and depression inlogist (2014), http://dx.doi.org/10.1016/j.ejr.2013.12.004

Assessment of health-related quality of life, anxiety and depression 5

education, job and disease activity. We found no gender differ-ence in the QoL in patients with early rheumatoid, this is inagreement with Dagfinrud et al. [22] and Salaffi et al. [4]

who found that the QoL was similar in men and women how-ever there were sex related differences as women reported low-er scores than men in role limitations due to physical function

and in general health subscales. These results were in contrastwith West and Jonsson [16]. The women in their studyreported significantly better physical functioning (PF) than

men at 24 months. Furthermore, we found no age differenceas regards the QoL which is in agreement with Thyberget al. [19] who found no relation with age or sex. On the otherhand, Nunez et al. [23] found that younger patients with the

highest socioeconomic level have better QoL.According to the education level, we found that highly edu-

cated patients have lower QoL than non-educated patients in

the domains of physical function, PCS and MCS although theyshowed a significant less bodily pain than non-educated. Thiswas in contrast with Salaffi et al. [4] who found that lower lev-

els of formal education have been reported to be a risk factorfor the presence of chronic musculoskeletal pain and physicalfunction. In our study we found the worst QoL between house-

wives than employees having a lower physical function andhigher bodily pain. This is in consistent with the study of Ha-bib et al. [24] and in contrast with Allaire et al. [25] who founda much lower prevalence of household work disability.

In our study, there is a significant inverse correlation be-tween disease activity score (DAS28) and the PCS and MCSscores, similar results were found in the study of Benitha and

Tikly [17] and also were consistent with the studies of Tayloet al. [26] and Aggarwal et al. [27] who found a significant ef-fect of disease duration, functional disability and disease activ-

ity on QoL.Depression in RA is closely associated with pain, work dis-

ability, health service utilisation, poor adherence to treatment

and suicide [28]. Regular mood assessment by rheumatologyclinical staff may serve to improve awareness and early identi-fication of depression, and thus timely identification and treat-ment of depression in RA are critical to overall clinical

management [28–29]. Chronic pain and restriction of physicalactivity, instability of the disease symptoms and clinical pro-gression, and ability to predict the prognosis increase the prev-

alence of anxiety in RA cases [30]. In our study we foundhighly significant increase in depression in patients comparedto the control, this is similar to the study of Smedstad et al.

[31] and Dickens et al. [32] but another study did not find thisdifference [33]. Our findings suggest that some of these differ-ences might be due to methodological problems such as lack ofthe use of strict criteria and appropriate controls.

In our study, we found strong correlation between depres-sion and anxiety on one hand and PCS and MCS on the otherhand, this is in agreement with Covic et al. [34] who found that

physical limitations predict emotional involvement especiallydepression, also there is a strong correlation between themand specifically the body pain affection.

In our study we found that patients with lower level of edu-cation had much higher level of anxiety than highly educatedpatients. Evers et al. [35] have reported that low educational

level is associated with depression and anxiety in RA cases.We also found a strong correlation between anxiety anddepression with the disease activity (DAS28) which is in consis-tent with Scot [36], who established that disease activity has a

Please cite this article in press as: Abu Al-Fadl EM et al. Assessmpatients with early rheumatoid arthritis, The Egyptian Rheumato

great influence on the joint damage and clinical outcomes. Theprevalence of anxiety in our study was 26.9% which was incontrast with El-Miedany and El-Rasheed [37] who found that

the prevalence of anxiety was higher than depression.Our study confirms that depression deserves more attention

in the care of patients with RA. The goal of treatment is to im-

prove the quality of life, concentrating on changing socio-psy-chological factors rather than simply bodily functions. This isin accordance with the results of another study [38]. Depres-

sion is a risk factor for non-compliance with medical treatmentin RA and is a risk factor for poor outcome. Such patientsmight not be adhering to medical advice [39].

In conclusion, early RA has a major impact on many areas

of an individual’s life and tends to have a profound impact onthe health-related quality of life.

Conflict of interest

The authors declare no conflict of interest.

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