Prospective evaluation of health-related quality of life after laparoscopic colectomy for cancer

Background

The aim of the present study was to prospectively determine health-related quality of life (HRQoL) changes and affecting factors after elective laparoscopic colectomy for cancer.

Methods

The SF-36, EORTC QLQ-C30 and QLQ-CR29, and Gastrointestinal Quality of life Index (GIQLI) were used to assess 85 patients preoperatively and at 1, 3, 6, and 12 months.

Results

An initial drop form baseline values was observed in 3 of 8 SF-36 domains, 3 of 5 QLQ-C30 functional scales and 1 of 5 GIQLI subscales. Emotional functioning (EF) was better postoperatively even from the first month (p = 0.03). Most functional domains were improved compared to baseline. The statistically significant changes (p < 0.05) were in the SF-36: general health (GH) (3 months), physical function (PF) (12 months) and role limitations due to emotional problems (12 months); in the QLQ-C30: EF (12 months); in the GIQLI: the global score and PF at 12 months and EF (3, 6, 12 months). From the first month after surgery, most QLQ-C30 “symptom” items were better than baseline. QLQ-CR29 “anxiety” and the “defecation problems” scales were significantly better than baseline at 1, 12 and at 6, 12 months (p < 0.05). Advanced stage (III) and chemotherapy were linked to worse EF, social function (SF), GH and global quality of life (QOL) at 3 and 6 months (p < 0.01). Males appeared to have a worse HRQoL than females at 3 and 6 months, and in 5 of 8 SF-36 domains and 3 of 5 GIQLI subscales at 12 months (p < 0.05). According to the QLQ-CR29, rectal surgery was associated more often with “impotence,” “stoma problems” and “incontinence” up to 6 months, and ostomies with “embarrassment” and “stoma problems” (p < 0.05).

Conclusions

HRQoL generally improved over the first year after laparoscopic colectomy reaching even better levels than before surgery. There was an early postoperative improvement in patients’ emotional status. The main factors affecting HRQoL seem to be tumor stage, chemotherapy and male sex.     

Development and validation of the revised Cedars-Sinai health-related quality of life for rheumatoid arthritis instrument

OBJECTIVE: To improve accuracy and content coverage of the original 33-item Cedars-Sinai Health-Related Quality of Life for Rheumatoid Arthritis Instrument (CSHQ-RA). METHODS: A total of 312 RA patients from 55 sites were screened in a 24-week trial. Patients completed an expanded 48-item version of the CSHQ-RA, Medical Outcomes Study Short Form 36 (MOS SF-36), and Stanford Health Assessment Questionnaire (HAQ) Disability Index at 5 visits. The revised CSHQ-RA was created based on response frequencies and distributions, item-to-item correlation, factor and Rasch analysis, and input from experts. Psychometric evaluation included internal consistency, test-retest reliability, convergent and discriminant validity, and responsiveness. Minimum clinically important difference (MCID) was also measured. RESULTS: Response rates were 93% at baseline and 71% at 12 weeks. Eighty-one percent of respondents at baseline were women, mean +/- SD age was 52 +/- 12 years, and mean +/- SD duration of RA was 10.8 +/- 10.4 years. The revised CSHQ-RA included 36 items measuring 7 domains (4 original and 3 new). All Cronbach's alpha coefficients were >0.8, indicating good internal consistency. Test-retest reliability measured intraclass correlation coefficients, which ranged from 0.86 to 0.95. All 7 domains correlated significantly with the MOS SF-36 and HAQ, indicating good convergent validity. Analysis of variance of disability group scores showed good discriminant validity (P < 0.0001). The MCIDs ranged from 6.2 for social well-being to 14.8 for pain/discomfort. CONCLUSION: The revised CSHQ-RA was validated using a broader RA patient population. It captures 3 additional domains (social well-being, pain/discomfort, and fatigue), which allow for measuring all important aspects of health-related quality of life.     

Evaluation of Patient-Reported Outcome in Subjects Treated Medically for Acute Pancreatitis: A Follow-Up Study

Aims: To explore the quality of life in patients treated medically during the acute phase of pancreatitis as well as at 2 and 12 months after discharge from the hospital. Patients: 40 patients were studied. The etiology of the pancreatitis was biliary causes in 31 patients and non-biliary causes in 9; mild disease was present in 29 patients and severe disease in 11. 30 patients completed the two surveys at 2 and 12 months after hospital discharge. Methods: The SF-12 and EORTC QLQ-C30 questionnaires were used for the purpose of the study. Results: The two physical and mental component summaries of SF-12, all the domains of EORTC QLQ-C30 (except for physical functioning and cognitive functioning) and some symptom scales of EORTC QLQ-C30 (fatigue, nausea/ vomiting, pain, and constipation) were significantly impaired during the acute phase of pancreatitis. There was a significant improvement in the SF-12 physical component summary, and global health, role functioning, social functioning, nausea/vomiting, pain, dyspnea, and financial difficulties (EORTC QLQ-C30) at 2 months after discharge as compared to the basal evaluation. Similar results were found after 12 months except for the mental component score at 12-month evaluation, which was significantly impaired in acute pancreatitis patients in comparison to the norms. The physical functioning of the EORTC QLQ-C30 at basal evaluation was significantly impaired in patients with severe pancreatitis in comparison to patients with mild pancreatitis. Conclusions: Two different patterns can be recognized in the quality of life of patients with acute pancreatitis: physical impairment is immediately present followed by mental impairment which appears progressively in the follow-up period.     

A Brazilian Portuguese version of the Revised Fibromyalgia Impact Questionnaire (FIQR): a validation study

The Fibromyalgia Impact Questionnaire (FIQ) was specifically developed to assess disease severity and functional ability in fibromyalgia patients. In 2009, a revised version of the FIQ was published, the FIQR; this version achieved a better balance among different domains (function, overall impact, symptoms). Here, we present the validity and reliability of the Brazilian version of the Revised Fibromyalgia Impact Questionnaire (FIQR). Female fibromyalgia patients (n?=?106) completed an online survey consisting of the Short Form 36 (SF-36) questionnaire, the original FIQ, and the Brazilian Portuguese FIQR, which was translated by a standard method. Validity was established with correlational analyses between the FIQR, FIQ, and SF-36 items. Three domains were established for the FIQR (function, overall impact, symptoms), and their contribution for the SF-36 subscales was also scrutinized. The Brazilian FIQR validation process showed that the questions performed in a very similar way to the original English FIQR. The new questions in the FIQR symptoms domain (memory, balance, tenderness, and environmental sensitivity) revealed a significant impact in fibromyalgia (FM) patients. The Brazilian Portuguese FIQR demonstrated excellent reliability, with a Cronbach’s alpha of 0.96. There was a gain on weight of the function domain and a decrease of the symptom domain, leading to a better balance among domains. The FIQR predicted a great number of SF-36 subscales, showing good convergent validity. The Brazilian Portuguese version of the FIQR was validated and found to be a reliable, easy-to-use, and score FM-specific questionnaire that should prove useful in routine clinical practice and FM-related research.     

International cross-cultural field validation of an European Organization for Research and Treatment of Cancer questionnaire module for patients with primary liver cancer, the European Organization for Research and Treatment of Cancer quality-of-life questionnaire HCC18

This international field validation study examined the psychometric properties and clinical validity of the European Organization for Research and Treatment of Cancer (EORTC) questionnaire module for hepatocellular carcinoma (HCC), the EORTC quality-of-life questionnaire (QLQ)-HCC18. The EORTC QLQ-HCC18 was administered with the core questionnaire, the EORTC QLQ-C30, to 272 patients from seven centers in 6 countries. Patient acceptability of the module was examined with a debriefing questionnaire, and psychometric and clinical properties were assessed. Multitrait scaling analyses confirmed the hypothesized scale structure without any scaling error, and the fatigue scale demonstrated satisfactory internal consistency. The test-retest reliability scores were high for all scales, except abdominal swelling and sexual interest. The correlations between all scales of the QLQ-HCC18 and the QLQ-C30 were low or moderate, and many scales could distinguish patients with different clinical conditions. The module demonstrated responsiveness to clinical change in pain before and after surgery and some borderline change in patients undergoing systemic treatment. Conclusion: The EORTC QLQ-HCC18 can be used as a supplementary module for the EORTC QLQ-C30 in clinical trials for patients with HCC.     

Acceptability and Psychometric Properties of the Minnesota Living With Heart Failure Questionnaire Among Patients Undergoing Heart Valve Surgery: Validation and Comparison With SF-36

BackgroundHealth-related quality of life (HQOL) enhancement is a major objective of valvular surgery (VS), but assessments have been limited primarily to generic measures that may not be optimally responsive to intervention. Disease-specific instruments have been used in heart failure (HF), commonly associated with valve disease, but have been neither validated nor routinely applied among patients undergoing VS.Methods and ResultsWe administered the Minnesota Living with Heart Failure (MLHFQ) and SF-36 questionnaires preoperatively (T₀) to 50 patients undergoing VS and at 1 (T₁) and 6 months (T₂) after VS. Performance of MLHFQ was evaluated and compared with SF-36. MLHFQ completion rates were >98% (NS vs. SF-36); Cronbach's α was ≥0.9 (total score, dimensions), supporting internal reliability. Confirmatory factor analysis verified good model fit for physical/emotional domain items (relative chi-squares <3.0, critical ratios >2.0, both instruments), supporting structural validity. Spearman coefficients correlating MLHFQ with parallel SF-36 domains were moderate to high (0.6-0.9; P ≤ .001: T₀-T₂), supporting convergent validity. Baseline HQOL was poorest in patients with HF (P ≤ .05 [both instruments]), supporting criterion validity. Responsiveness (proportional HQOL change scores: T₀ vs. T₂) to VS was greater with MLHFQ vs. SF-36 (P ≤ .002).ConclusionsAmong patients undergoing VS, the MLHFQ is highly acceptable and maintains good psychometric properties, comparing favorably with SF-36. These findings suggest its utility for measuring disease-specific HQOL changes after VS.     

Validation of the Quality-of-Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-26) in Korean population

We aimed to evaluate the reliability and validity of the adapted Korean version of the Quality-of-Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-26). Translation/retranslation of the English version of QUALEFFO was conducted, and all steps of the cross-cultural adaptation process were performed. The Korean version of the visual analog scale measure of pain, QUALEFFO-26 and the previously validated Short Form-36 (SF-36) were mailed to 162 consecutive patients with osteoporosis. Factor analysis and reliability assessment by kappa statistics of agreement for each item, the intraclass correlation coefficient and Cronbach’s α were conducted. Construct validity was also evaluated by comparing the responses of QUALEFFO-26 with the responses of SF-36 using Pearson’s correlation coefficient. Factor analysis extracted 3 factors. All items had a kappa statistics of agreement greater than 0.6. The QUALEFFO-26 showed good test/retest reliability (QUALEFFO-26: 0.8271). Internal consistency of Cronbach’s α was found to be very good (QUALEFFO-26: 0.873). The Korean version of QUALEFFO-26 showed good significant correlation with SF-36 total score and with single SF-36 domains scores. The adapted Korean version of the QUALEFFO-26 was successfully translated and showed acceptable measurement properties and, as such, is considered suitable for outcome assessments in the Korean-speaking patients with osteoporosis.     

Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure

OBJECTIVES: To create a valid, sensitive, disease-specific health status measure for patients with congestive heart failure (CHF). BACKGROUND: Quantifying health status is becoming increasingly important for CHF. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a new, self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. METHODS: To establish the performance characteristics of the KCCQ, two distinct patient cohorts were recruited: 70 stable and 59 decompensated CHF patients with ejection fractions of <40. Upon entry into the study, patients were administered the KCCQ, the Minnesota Living with Heart Failure Questionnaire and the Short Form-36 (SF-36). Questionnaires were repeated three months later. RESULTS: Convergent validity of each KCCQ domain was documented by comparison with available criterion standards (r = 0.46 to 0.74; p < 0.001 for all). Among those with stable CHF who remained stable by predefined criteria (n = 39), minimal changes in KCCQ domains were detected over three months of observation (mean change = 0.8 to 4.0 points, p = NS for all). In contrast, large changes in score were observed among patients whose decompensated CHF improved three months later (n = 39; mean change = 15.4 to 40.4 points, p < 0.01 for all). The sensitivity of the KCCQwas substantially greater than that of the Minnesota Living with Heart Failure and the SF-36 questionnaires. CONCLUSIONS: The KCCQis a valid, reliable and responsive health status measure for patients with CHF and may serve as a clinically meaningful outcome in cardiovascular research, patient management and quality assessment.     

Psychometric properties of a Chinese asthma quality of life questionnaire

Purpose: To assess the acceptability, reliability, validity, and responsiveness of the Chinese Asthma Quality of Life Questionnaire (C-AQLQ) in a sample of Chinese asthma patients. Methods: The C-AQLQ and Short Form 36 Health Survey (SF-36) scales were administered to patients at baseline and 3 months later. Asthma severity condition and lung function were evaluated. Necessary data were gathered to assess the psychometric properties such as the feasibility, internal consistency, test-retest reliability, structural validity, discriminant validity, convergent validity, and responsiveness of the C-AQLQ. Results: One hundred and thirty-seven patients completed the investigation. The Cronbach's alpha coefficient for the total scale was 0.96. Factor analysis yielded five factors that generally corresponded to the five proposed subscales. Patients with mild asthma reported higher scores than patients with moderate/severe asthma on all subscales other than environmental stimuli. Lung function measurement and the asthma severity score correlated significantly with domains of the C-AQOL but with fewer domains of the SF-36. The questionnaire detected within-subject changes in patients' asthma status during follow-up. Conclusions: Results indicated preliminary support that the C-AQLQ is a reliable, valid, discriminating, and responsive measure of quality of life in Chinese asthma patients. It is more sensitive than the generic SF-36 in detecting differences in asthma severity.     

Performance of a short lung-specific health status measure in outpatients with chronic obstructive pulmonary disease.

The objective of this study was to assess the performance of a lung-specific health status measure in patients with chronic obstructive pulmonary disease (COPD). We used the Respiratory Quality of Life Questionnaire (RQLQ), a modification of an Australian questionnaire intended for asthma patients and adapted in this study to fit patients with COPD also. For comparison we chose the general health profile measure Short Form 36 (SF-36). We assessed the five RQLQ scales and eight SF-36 scales for reliability, validity and responsiveness in 59 outpatients attending a Norwegian hospital for COPD. Statistical analysis included internal consistency, test-retest reliability and convergent validity between the two questionnaires. Responsiveness was assessed in patients reporting global change in health status over 1 year. All scales of the RQLQ showed good internal consistency (Cronbach's a = 0.85-0.94) and test-retest reliability (intraclass correlation coefficient = 0.86-0.94), as did the SF-36 scales (a = 0.66-0.90) and intraclass correlation coefficient = 0.60-0.86). Pearson correlations between scales with similar items ranged from 0.54 to 0.76, supporting the construct validity of both questionnaires. The RQLQ had responsive scales, showing significant changes in the expected direction over 1 year. We conclude that the RQLQ showed an acceptable reliability, construct validity and responsiveness in COPD patients, encouraging further use of this questionnaire.     

The reliability, validity and sensitivity to change of the Chinese version of SF-36 in oriental patients with rheumatoid arthritis

OBJECTIVE: To assess the reliability, validity and sensitivity to change of a Chinese version of the 36-item Short-Form Health Survey (SF-36) in Chinese-speaking patients with rheumatoid arthritis (RA) in Singapore. METHODS: The psychometric properties of the Chinese Hong Kong standard version of the SF-36 were assessed in 401 RA patients. The construct validity of the Chinese SF-36 was assessed by comparison with the American College of Rheumatology (ACR) functional status, a validated Chinese Health Assessment Questionnaire (C-HAQ) and markers of RA activity and severity. RESULTS: The overall Cronbach's coefficient alpha was 0.921, reflecting excellent internal consistency. The instrument showed reasonable test-retest reliability except in the social functioning (SF) subscale. There was a significant ceiling effect in the role physical (RP), SF and role emotional (RE) subscales and a floor effect in the RP and RE subscales. Physical function (PF) and SF were strongly correlated with C-HAQ and patient's assessment of RA activity [Pearson's correlation coefficient (r) ranging from -0.41 to -0.53] and moderately correlated with ACR functional status (r = -0.35 and -0.3, respectively). Weak correlations were also found between the Chinese SF-36 and markers of RA activity, deformed joint count and radiographic damage. PF and SF were the subscales most responsive to change in quality of life (QOL). CONCLUSION: The Chinese SF-36 showed reasonable reliability, criterion validity and responsiveness with limitations in certain subscales. Overall, the physical domains and PF in particular may be the most ideal psychometric measures of QOL in RA.     

Internal consistency and validity of the Spanish version of the "Quebec Sleep Questionnaire" quality-of-life questionnaire for obstructive sleep apnea

Introduction

There is no specific health-related quality of life (HRQL) questionnaire that has been validated in Spanish for its use in patients with sleep apnea-hypopnea syndrome (SAHS). The objective of the present study was to validate the Spanish version of the Quebec Sleep Questionnaire (QSQ).

Patients and methods

A multi-center study including a group of patients with SAHS (AHI ≥ 5) referred to the Sleep Unit. All patients completed the following questionnaires: SF-36, FOSQ, QSQ and Epworth scale. Internal consistency, construct validity, concurrent validity, predictive validity, repeatability and responsiveness to change of the QSQ (32 items in five domains: daytime sleepiness, diurnal symptoms, nocturnal symptoms, emotions, and social interactions) were assessed.

Results

A hundred twenty one patients were included in the study (mean age: 57 ± 13; mean Epworth: 9 ± 4; mean Body Mass Index (BMI): 28 ± 3 kg · m⁻² and mean AHI: 36 ± 20 hour⁻¹). The factorial analysis showed a construct of five factors with similar distribution to the original questionnaire domains. Internal consistency (Cranach's alpha between 0.78 and 0.93 for the different domains), concurrent validity (compared to SF-36, Epworth scale and FOSQ), predictive validity of SAHS severity and test-retest reliability were appropriate. The test showed good responsiveness to change in diurnal (P = .003) and nocturnal symptoms domains (P = .02).

Conclusions

The Spanish version of the QSQ is a valid HRQL measure with appropriate psychometric properties for use in patients with SAHS and is responsive to change in symptoms domains.     

Quality of life scale and impact of a topical treatment on symptoms of gastro-esophageal reflux without severe esophagitis

OBJECTIVE: Restoring a normal quality of life (QOL) should be the goal of treatments of gastro-esophageal reflux (GER) without severe esophagitis. In this analysis, carried out within the frame of a clinical study comparing a topical anti-inflammatory gel to a placebo, we assessed the relevance of the MOS SF-36 questionnaire in patients suffering from GER without severe esophagitis, and compared the scores of the studied patients to those of a representative sample of the French general population. PATIENTS AND METHODS: The patients had to suffer from GER symptoms for at least 2 months, with no or mild (< or =grade 1) esophagitis endoscopy. They were randomized to be given a 4 week treatment either with a topical gel containing ga?azulene and dimeticone or a placebo gel. Patients were asked to complete a symptom diary during the study, which allowed the calculation of mean symptom scores. The MOS SF-36 questionnaire was administered at baseline (d0) and after 4 weeks of treatment (d28). RESULTS: Two hundred and thirty three patients were enrolled in the study. At baseline, QOL scores were impaired in both groups. After 4 weeks of treatment: the treated patients displayed better improvement in all MOS SF-36 domains compared with the placebo group. The QOL profile in the treated group reached the level of the French reference population, while it remained impaired in the placebo group. CONCLUSION: This analysis evidenced the relevancy of the MOS SF-36 questionnaire to assess the impact of GER without severe esophagitis on QOL. Moreover, it demonstrated the capacity of the studied topical treatment to restore a normal QOL to the patients.     

Development and preliminary validation of a systemic lupus erythematosus-specific quality-of-life instrument (SLEQOL)

OBJECTIVES: Systemic lupus erythematosus (SLE), a chronic illness with an unpredictable and variable course, profoundly affects the quality of life (QOL). General health questionnaires are used to assess QOL in SLE, but a disease-specific instrument could offer enhanced responsiveness and content validity. We detail the steps we took to develop and validate a new SLE-specific QOL instrument, SLEQOL. METHODS: Rheumatology professionals nominated items that they felt were important determinants of QOL of SLE patients. One hundred SLE patients were asked to assess the importance and frequency of occurrence of these items and to suggest those that had not been listed. Item reduction was performed using Rasch model and factor analyses to create a new questionnaire in English. This final questionnaire was administered to a cohort of 275 patients to study its psychometric properties. RESULTS: Fifty-one items covering a wide range of QOL concerns were identified. The patients' responses led to the elimination of 11. The new questionnaire of 40 items was found to have Cronbach's alpha of 0.95 and to consist of eight domains covering physical, mental and social QOL issues. It has good test-retest reliability, poor to fair cross-sectional correlation with the SF-36, with poor correlation with lupus activity or damage indices. The SLEQOL was more responsive to change than the SF-36. CONCLUSIONS: We have developed a new 40-item SLEQOL in English and showed that it is valid for use in SLE patients in Singapore. It offers better content validity and responsiveness to change than the SF-36.     

Comparison of internal and external responsiveness of the generic Medical Outcome Study Short Form-36 (SF-36) with disease-specific measures in rheumatoid arthritis

OBJECTIVE: To examine the comparative internal and external responsiveness of the generic Medical Outcome Study Short Form-36 Health Survey (SF-36) and disease-specific measures in patients with rheumatoid arthritis (RA). METHODS: Data were collected from 280 RA patients starting anti-tumor necrosis factor treatment. A total of 168 patients completed a questionnaire including the SF-36, the Arthritis Impact Measurement Scales 2 (AIMS2), the Health Assessment Questionnaire (HAQ), a visual analog scale for general health (VAS-GH), and an 11-point numerical rating scale for pain (NRS pain) at baseline and after 12 months. Internal responsiveness was evaluated with paired samples t-tests and standardized response means (SRM). External responsiveness was investigated with receiver-operating characteristic statistics and Spearman rank-order correlation coefficients. A health transition item was used as the external indicator of change. RESULTS: No significant differences in internal and external responsiveness were found between the SF-36 and disease-specific measures within the domains physical function, pain, and psychological function. In the domain social function, the SF-36 was more responsive than the AIMS2. In the domain general health, the SF-36 was less responsive (only internal) than the AIMS2 and VAS-GH. CONCLUSION: Our study showed comparable internal and external responsiveness of the SF-36 compared with disease-specific measures (AIMS2, HAQ, NRS pain) in all health domains, except social function and general health domains. The assumption that disease-specific measures are more responsive to detect intervention-related changes over time is not confirmed by our data.     

Impact of irritable bowel syndrome on patients' lives: development and psychometric documentation of a disease-specific measure for use in clinical trials

OBJECTIVE: To develop a disease-specific questionnaire to capture the impact of irritable bowel syndrome (IBS) and its treatment on patients' lives, the Irritable Bowel Syndrome Impact Scale (IBS-IS). PATIENTS AND METHODS: One hundred and fifty-five IBS patients participated (126 (81%) female; age (mean+/-SD) 45.5+/-12.4 years). We developed the initial 39 items from the literature, available IBS-specific instruments and input from physicians, nurses and patients. We deleted IBS-IS items with a high ceiling effect, items that measured a different construct and items showing a high correlation (r>0.90) with another item and with Rasch analysis, leaving 26 items. We then applied exploratory factor analysis to examine domain groupings. Subjects completed the IBS-IS instrument, the Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS), Short Form-36 (SF-36), Visceral Sensitivity Index (VSI), and Hospital Anxiety and Depression (HAD) scale. Internal consistency, construct validity and discriminate validity were assessed. RESULTS: The 26 items represented five domains: fatigue, impact on daily activities, sleep disturbance, emotional distress and eating habits. The internal consistency reliability for the domains was 0.87 to 0.96. Most associations between similar constructs in the IBS-IS, GSRS-IBS, SF-36, VSI, and HAD were >0.40. Each IBS-IS domain score decreased with increasing IBS symptom severity (P<0.05), and the patients scored >5 score units lower than a US general population scored on all eight SF-36 dimensions. CONCLUSION: The IBS-IS is a short, user-friendly instrument with excellent psychometric properties that has potential usefulness for clinical trials.     

Validation of a German version of the Fibromyalgia Impact Questionnaire (FIQ-G)

OBJECTIVE: To translate the Fibromyalgia Impact Questionnaire (FIQ) into German and to evaluate its reliability and validity for the use of German speaking patients with fibromyalgia (FM). METHODS: We administered the FIQ to 55 patients with FM (15 patients filled out the questionnaire 10 days later) together with German versions of the Stanford Health Assessment Questionnaire (HAQ), the Medical Outcomes Survey Short Form-36 (SF-36), and a tender point count (TPC). All patients were asked about the severity of pain today (10 cm visual analog scale) and the duration of symptoms. Tenderness thresholds were assessed by dolorimetry at all tender points with a Fisher dolorimeter and laboratory tests were obtained. Test-retest reliability was assessed using Spearman correlations. Internal consistency was evaluated with Cronbach's alpha of reliability. Construct validity of the FIQ was evaluated by correlating the HAQ and subscales of the SF-36 as well as the TPC and the tenderness thresholds. RESULTS: Mean age of participants was 54.3 years and mean duration of symptoms 9.5 years. Test-retest reliability was between 0.62 and 1 for the physical functioning as well as for the total FIQ and other components. Internal consistency was 0.92 for the overall FIQ. Significant correlations were obtained between the FIQ items, the HAQ, and the SF-36. CONCLUSION: The German FIQ is a reliable and valid instrument for measuring functional disability and health status in German patients with FM.     

Generic and condition-specific outcome measures for people with osteoarthritis of the knee.

OBJECTIVES: The aims of this study were to evaluate two condition-specific and two generic health status questionnaires for measuring health-related quality of life in patients with osteoarthritis (OA) of the knee, and to offer guidance to clinicians and researchers in choosing between them. METHODS: Patients were recruited from two settings: 118 from knee surgery waiting lists and 112 from rheumatology clinics. Four self-completion questionnaires [Western Ontario and McMaster University Osteoarthritis Index (WOMAC), Health Assessment Questionnaire (HAQ), Short Form-36 (SF-36) and Euroqol] were sent to subjects on two occasions 6 months apart. Construct validity, convergent validity, internal consistency and responsiveness were examined using primarily non-parametric methods. RESULTS: All instruments proved satisfactory in terms of ease of use, acceptability to patients, internal consistency and reliability. In the surgical group, the OA-specific WOMAC performed better than the HAQ and the generic measures in terms of validity and responsiveness to change, whereas in the rheumatology group the SF-36 was more responsive. CONCLUSION: WOMAC is the instrument of choice for evaluating the outcome of knee replacement surgery in OA. The SF-36 provides a more general insight into patients' health and may be more responsive to change than the WOMAC in a heterogeneous rheumatology clinic population. Researchers wishing to undertake an economic evaluation might consider the EQ-5D for a surgical, but not a rheumatology clinic group.     

Physical function and health related quality of life: analysis of 2-year data from randomized, controlled studies of leflunomide, sulfasalazine, or methotrexate in patients with active rheumatoid arthritis

OBJECTIVE: To determine whether improvements in physical function and health related quality of life (HRQOL) are sustained over 2 years of blinded treatment with leflunomide (LEF), methotrexate (MTX), or sulfasalazine (SSZ) in patients with active rheumatoid arthritis (RA). METHODS: Three phase III randomized, controlled trials compared LEF, MTX, and SSZ in patients with active RA. Improvements in physical function were assessed by Health Assessment Questionnaire Disability Index (HAQ-DI) and Modified Health Assessment Questionnaire (MHAQ); monthly MHAQ and mean HAQ scores were used to calculate American College of Rheumatology responses; HAQ-DI was assessed at baseline and 6-month intervals. In US301, the Medical Outcomes Study 36-Item Short-Form questionnaire (SF-36) assessed treatment-associated changes in HRQOL at baseline and 6-month intervals. RESULTS: Mean and median improvements in HAQ-DI after 12 and 24 months of active treatment in all phase III protocols significantly exceeded -0.22 or a minimum clinically important difference (MCID). These improvements closely reflected positive changes in SF-36 that met or exceeded MCID in all domains with LEF and MTX treatment. Problem Elicitation Technique Top 5 scores reflected improvements in performance of physical activities most important to patients. CONCLUSION: Improvements in physical function were sustained over 24 months of successful treatment with LEF, MTX, and SSZ, and reflected improvements in mental as well as physical domains of HRQOL.     

The Hebrew version of the FibroFatigue scale: validation of a questionnaire for assessment of fibromyalgia and chronic fatigue syndrome

The objective of this study is to validate a translated Hebrew version of the FibroFatigue Scale (FFS). The Hebrew version of the FFS was administered to 100 patients fulfilling ACR criteria for classification of FM together with the validated Hebrew version of the Fibromyalgia Impact Questionnaire (FIQ), the validated Hebrew version of the Short Form-36 (SF-36) and a Visual Analogue Scale (VAS) measurement of pain, anxiety, depression, morning stiffness and global well being. Test–retest reliability was assessed using Spearman correlations. Internal consistency was evaluated with Cronbach’s α of reliability. Construct validity of the FFS was evaluated by correlations among the FFS, the FIQ and the subscales of the SF-36. Mean duration of symptoms was 10.7 years, and mean age of participants was 53.5 years. Test–retest reliability was between 0.46 and 0.85 for the various FFS items. Internal consistency was 0.89 for the overall FFS. Significant correlations were obtained between the FFS items and the SF-36. These results support the reliability and validity of the data obtained with the Hebrew version of the FSS for detecting and measuring symptom severity in Hebrew speaking patients with FM.