Quality of life and self-reported disability in patients with knee osteoarthritis

Abstract

Objectives Osteoarthritis (OA) is the most common degenerative joint disorder and a major public health problem throughout the world. The aims of this study are to assess quality of life (QoL) in patients with knee OA using the generic instrument Short Form-36 (SF-36) and to determine its relationships with conventional clinical measures and self-reported disability.

Methods Patients with knee OA (n = 112) with median age of 60 (45–76) years and 40 sex- and age-matched healthy controls were included in the study. Age, sex, body mass index (BMI), symptom duration, and Kellgren–Lawrence scores were recorded. QoL, disability, and pain were assessed using the SF-36, the Western Ontario and McMaster (WOMAC) index, the Lequesne index, and a visual analog scale (VAS) in patients. Also, QoL was assessed using the SF-36 in controls.

Results Patients with knee OA had lower scores in all subgroups of SF-36 compared with controls. In patients, the SF-36 physical function (PF) and pain areas significantly correlated with effusion, VAS pain, and Lequesne and WOMAC subgroup scores (p < 0.05). The pain area of QoL did not show correlation with comorbidity with knee OA. We found that SF-36 and WOMAC pain scores were more severe in female patients.

Conclusions Patients with knee OA had significantly poorer QoL compared with healthy controls. SF-36 is related to the clinical status and functional ability of patients with OA and can be used as a sensitive health status measure for clinical evaluation. Also WOMAC can be used as a sensitive measure for disability of patients with knee OA.     

Responsiveness of the WOMAC osteoarthritis index as compared with the SF-36 in patients with osteoarthritis of the legs undergoing a comprehensive rehabilitation intervention

OBJECTIVE: To compare the responsiveness of the condition-specific Western Ontario and McMaster Universities osteoarthritis (OA) index (WOMAC) and the generic Short Form-36 (SF-36) in patients with OA of the legs undergoing a comprehensive inpatient rehabilitation intervention. METHODS: A prospective follow up study of consecutively referred inpatients of a rehabilitation clinic was made. The patients included fulfilled the American College of Rheumatology criteria for knee or hip OA and underwent both passive and, particularly, active physical therapy for three to four weeks. Responsiveness assessment was performed using the standardised response mean (SRM), effect size, and Guyatt's responsiveness statistic between admission and discharge (end of rehabilitation) and then again between admission and three months later. For pain and function the SRMs were stratified by sex and OA joint. Effects were tested by the t test and SRMs of different scales were compared by the jack knife test. RESULTS: At the three month follow up, complete data were obtained for 223 patients. In general, the three responsiveness statistics showed a similar order of responsiveness. For both instruments, the pain scales were more responsive than the function scales. The responsiveness of the pain scale of both instruments was comparable (SRM=0.723 for WOMAC and SRM=0.528 for SF-36 at the end of rehabilitation; SRM=0.377 for WOMAC and SRM=0.468 for SF-36 at the three month follow up). In the measurement of function, the WOMAC was significantly more responsive than the SF-36 (SRMs, end of rehabilitation: 0.628 v 0.249; three month follow up: 0.235 v -0.001). Responsiveness tended to be higher in women and in knee OA than in men and hip OA. CONCLUSIONS: Both instruments, the WOMAC and the SF-36, capture improvement in pain in patients undergoing comprehensive inpatient rehabilitation intervention. Functional improvement can be detected better by the WOMAC than by the SF-36. All the other scales of both instruments were more weakly responsive.     

Inpatient rehabilitation for hip or knee osteoarthritis: 2 year follow up study

OBJECTIVE: To examine the course of pain, physical function, and other health dimensions after a comprehensive inpatient rehabilitation intervention in patients with osteoarthritis (OA) of the hip or knee. METHODS: An observational, prospective cohort study with assessments at baseline (entry into clinic), 1 (discharge from inpatient rehabilitation), 3, 6, 9, 12, and 24 months after baseline. Consecutively referred patients to an inpatient rehabilitation centre fulfilling the inclusion criteria were studied. 3-4 week comprehensive rehabilitation intervention, including strengthening exercise, flexibility training, endurance training, relaxation strategies, and consultations for preventive measures, was carried out. Individual home rehabilitation programmes were taught. Generic health status was measured using the SF-36, condition specific health was measured with the WOMAC questionnaire. Effects were analysed with sensitivity statistics (effect size, ES) and non-parametric tests. RESULTS: Data from 128 patients with complete follow up data were analysed. Both pain and physical function improved moderately (WOMAC pain: ES = 0.56, WOMAC function ES = 0.44) until discharge. Although the effect in pain reduction remained significant by month 24 (WOMAC: ES = 0.26), physical function deteriorated close to baseline values after 12 months. CONCLUSIONS: Comprehensive inpatient rehabilitation of patients with OA of the hip or knee may improve pain and physical function in the mid-term, and pain in the long term.     

Living with osteoarthritis: patient expenditures, health status, and social impact.

OBJECTIVE: To determine "out-of-pocket" expenditures related to osteoarthritis (OA) and to explore whether demographic details, health status scores (Medical Outcomes Study 36-item Short Form [SF-36] and Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), or perception of social effect were expenditure determinants. METHODS: A prospective cohort study of community-dwelling subjects with OA completed 4 consecutive 3-month cost diaries. In addition, subjects completed the SF-36 and WOMAC at baseline and at 12 months. Social impact at baseline was collected. Four groups categorized by age and sex were compared. Patients undergoing joint replacement were excluded. RESULTS: Differences in health status were defined more by age than by sex, especially for physical function. The costs to the patients were high, particularly for women, who spent more on medications and special equipment. Women also reported receiving more assistance from family and friends. Higher disease-related expenditures were associated with greater pain levels, poorer social function and mental health, and longer duration of disease. Significant independent predictors of total patient expenditures related to OA were being female and having joint stiffness. CONCLUSION: Despite having heavily subsidized health care and access to the Pharmaceutical Benefits Scheme, out-of-pocket costs for patients with OA in Australia are considerable. Higher expenditures for patients with OA are related to more advanced disease, especially for women.     

Improved WOMAC score following 16-week treatment with bromelain for knee osteoarthritis

Treatment with bromelain-containing enzyme preparation for 3–4 weeks is effective for treatment of knee osteoarthritis (OA). Here, we aimed to assess 16-week treatment with bromelain in mild-to-moderate knee OA patients. We performed a randomized, single-blind, active-controlled pilot study. Forty knee OA patients were randomized to receive oral bromelain (500 mg/day) or diclofenac (100 mg/day). Primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) analyzed by Wilcoxon signed rank test. Secondary outcome was the short-form 36 (SF-36). Plasma malondialdehyde (MDA) and nitrite were measured as oxidative stress markers. There was no difference in WOMAC and SF-36 scores compared between bromelain and diclofenac groups after 4 weeks. At week 4, the improvement of total WOMAC and pain subscales from baseline was observed in both groups; however, two patients given diclofenac had adverse effects leading to discontinuation of diclofenac. However, observed treatment difference was inconclusive. At week 16 of bromelain treatment, the patients had improved total WOMAC scores (12.2 versus 25.5), pain subscales (2.4 versus 5.6), stiffness subscales (0.8 versus 2.0), and function subscales (9.1 versus 17.9), and physical component of SF-36 (73.3 versus 65.4) as compared with baseline values. OA patients had higher plasma MDA, nitrite, and prostaglandin E₂ (PGE₂) in lipopolysaccharide (LPS)-stimulated whole blood but lower plasma α-tocopherol than control subjects. Plasma MDA and LPS-stimulated PGE₂ production were decreased at week 16 of bromelain treatment. Bromelain has no difference in reducing symptoms of mild-to-moderate knee OA after 4 weeks when compared with diclofenac.     

Validation of the Comprehensive ICF Core Set for Osteoarthritis (OA) in patients with knee OA: a Singaporean perspective

OBJECTIVE: To evaluate content validity and construct validity of the International Classification of Functioning, Disability and Health (ICF) Comprehensive Core Set for Osteoarthritis (OA) in Singapore. METHODS: Patients with knee OA completed case report forms, which included the SF-36, Self-administered Comorbidity Questionnaire (SCQ), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Health professionals completed the ICF Comprehensive Core Set for OA. Content validity was evaluated using frequency and percentage of patients with a reported problem for each ICF category, while construct validity was evaluated using Spearman correlation between the ICF categories and SF-36 and the WOMAC. RESULTS: A consecutive sample of 122 patients completed this study. In body functions, 12 categories were documented as a problem by more than 10% of the patients, of which 7, 12, and 10 categories correlated significantly with the SF-36 Physical Component Summary (PCS), WOMAC pain, and physical function, respectively. Only s750 (Structure of lower extremity) in body structures was reported as a problem and correlated significantly with SF-36 and WOMAC. In activities and participation, 12 categories were reported as a problem by more than 10% of the patients, of which, 11, 11, and 12 correlated significantly with SF-36 PCS, WOMAC pain, and physical function, respectively. In environmental factors, 2 and 14 categories were documented as barrier and facilitator, respectively, by more than 10% of the patients, but none correlated significantly with SF-36 and WOMAC. CONCLUSION: The content and construct validity of the Comprehensive Core Set for OA could be supported. Some categories, especially in environmental factors, need to be studied further in different sociocultural contexts.     

Steroid injection for osteoarthritis of the hip: a randomized, double-blind, placebo-controlled trial

OBJECTIVE: To determine the efficacy of fluoroscopically guided corticosteroid injection for hip osteoarthritis (OA) in a randomized, double-blind, placebo-controlled trial. METHODS: Fifty-two patients with symptomatic hip OA were randomly allocated to receive placebo (10 mg bipuvicaine, 2 ml saline) (n = 21) or corticosteroid treatment (10 mg bipuvicaine, 40 mg triamcinolone hexacetonide) (n = 31). Patients were followed up for 1, 2, 3, and 6 months. The primary outcome measure was the pain improvement response, defined as a 20% decrease in the Western Ontario and McMaster Universities OA Index (WOMAC) pain score (on 5 100-mm visual analog scales [VAS]) (WOMAC20) from baseline to 2 months postinjection. Secondary outcomes were a 50% decrease in the WOMAC pain score (WOMAC50), changes in other WOMAC subscale scores, patient's global assessment of health (on a 100-mm VAS), and Short Form 36 (SF-36) quality of life indices. Analyses were based on the intent-to-treat principle. RESULTS: The mean WOMAC pain score fell 49.2% (decreasing from 310.1 mm to 157.4 mm) at 2 months postinjection in patients receiving corticosteroid, compared with a decrease of 2.5% (from 314.3 mm to 306.5 mm) in the placebo group (P < 0.0001). The proportion of WOMAC20 responders at 2 months' followup was significantly higher in the corticosteroid group (67.7%) compared with the placebo group (23.8%) (P = 0.004); similar proportions of WOMAC50 responders were observed between groups (61.3% in the corticosteroid group versus 14.3% in the placebo group; P = 0.001). Response differences were maintained at 3 months' followup (58.1% responders in the corticosteroid group versus 9.5% responders in the placebo group; P = 0.004). Significant differences in the WOMAC stiffness and physical function scores (P < 0.0001), patient's global health scores (P = 0.005), and SF-36 physical component scores (P = 0.04) were observed, with patients in the corticosteroid group showing greater improvements. There were no differences in the frequency of adverse events between groups. CONCLUSION: This placebo-controlled trial confirms that corticosteroid injection can be an effective treatment of pain in hip OA, with benefits lasting up to 3 months in many cases. Future studies should address questions related to the benefits of repeated steroid injection and the effects of this treatment on disease modification.     

Comparative responsiveness of measures of pain and function after total hip replacement.

OBJECTIVE: To compare the responsiveness of the Functional Assessment System (FAS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Medical Outcomes Study 36-item Short Form (SF-36) in patients with osteoarthritis (OA) scheduled for total hip replacement. METHOD: Twenty patients with a mean age at surgery of 72.6 years, with primary OA of the hip, were investigated preoperatively and at 3, 6, and 12 months postoperatively with the FAS, WOMAC, and SF-36. The responsiveness was calculated as standardized response mean, effect size, and relative efficiency. RESULTS: The pain and function scores of WOMAC and SF-36 showed greater responsiveness than FAS at 3 months. These differences remained at 6 and 12 months postoperatively. The differences between these 3 outcome measures were found to be similar using several methods for calculating responsiveness. CONCLUSION: Self-administered questionnaires like WOMAC and SF-36 are more responsive measures of pain and function than range of motion, performance tests, and observer-administered questions (FAS) following total hip replacement.     

Predictors of patient relevant outcome after total hip replacement for osteoarthritis: a prospective study

OBJECTIVES: To investigate prospectively long term patient relevant outcomes after unilateral total hip replacement (THR) for osteoarthritis (OA). To identify non-responders to this intervention and patient related predictors of unsatisfactory outcome. METHODS: A case-control study comparing health related quality of life of 219 patients (mean age 71) after THR with that of a matched reference group of 117 subjects without hip complaints recruited from the community. Patients and reference group answered SF-36 and WOMAC questionnaires preoperatively, at 3, 6, 12 months, and at 3.6 years (range 26-65 months) postoperatively. Supplementary questions were asked at the final follow up. RESULTS: 198/211 (94%) of the patients and 83/109 (76%) of the reference group participated at the final follow up. At follow up, the only difference between the two groups in the SF-36 was physical function, where patients scored worse. Patients also reported worse WOMAC function. 31% of the patients had improved by <10/100 WOMAC score points for pain and/or function at final follow up, compared with preoperatively. More pain preoperatively and higher age and postoperative low back pain predicted a worse outcome in WOMAC function. CONCLUSION: 3.6 years after THR for OA, health related quality of life was similar for patients and reference group except for function, where patients had worse function. Higher age and more pain preoperatively predicted a poor outcome. Patients with hip OA with musculoskeletal comorbidities, such as low back pain and OA of the non-operated hip, have less long term functional improvement after THR.     

Greater reduction of knee than hip pain in osteoarthritis treated with naproxen, as evaluated by WOMAC and SF-36

OBJECTIVES: To compare the improvement of hip and knee osteoarthritis during treatment with naproxen. METHODS: Men and women aged 40 to 75 years with symptomatic osteoarthritis of the knee or hip of at least three months' duration participated in a six week placebo controlled, double blind study with naproxen 500 mg twice daily as one treatment arm. Naproxen was given to 403 patients (280 knee, 123 hip) and placebo to 108 patients (75 knee, 33 hip). WOMAC (Western Ontario and McMaster Universities osteoarthritis index) 3.1 visual analogue scale and SF-36 (36 item short form health survey) were used to assess response to treatment between baseline and week 6. RESULTS: There were no differences at baseline between knee and hip osteoarthritis for any of the WOMAC subscales or SF-36 domains. Improvement was between 4 and 7 mm greater for knee than for hip for all WOMAC subscales (pain, delta = 4.7 mm (p = 0.03); stiffness, delta = 6.6 mm (p = 0.004); function, delta = 4.8 mm (p = 0.06)). Effect size was about 0.8 for all WOMAC subscales for the knee and between 0.5 and 0.6 for the hip. Knee patients treated with naproxen improved 4.6 (p = 0.033) more than hip patients for SF-36 bodily pain and 10.3 (p = 0.014) more for SF-36 role-physical. CONCLUSIONS: Patients with knee osteoarthritis improved more with naproxen treatment than patients with hip osteoarthritis, as monitored by WOMAC and the SF-36 domains bodily pain and role-physical. These findings warrant further investigation and strongly suggest that efficacy of treatment of osteoarthritis of knee and hip should be evaluated separately.     

Health-related quality of life measured by the Short Form 36 in immune thrombocytopenic purpura: a cross-sectional survey in China

OBJECTIVES: The aim of this study is to assess the quality of life (QoL) of Chinese adults with idiopathic thrombocytopenic purpura (ITP). METHODS: The Chinese (mainland) version of Medical Outcome Study SF-36 form (SF-36) Health Survey was used to measure health-related QoL of 236 adults with ITP in a cross-sectional study. RESULTS: Comparison of SF-36 subscores of patients with ITP with healthy individuals revealed the reduction of QoL in all of the eight SF-36 dimensions. The difference on statistical significance presented in six of eight dimensions of SF-36 including physical functioning (PF), role limitations due to physical problems, body pain, general health perception (GH), social functioning (SF), and role limitations due to emotional problems (RE) between the patients with ITP and the normal population (P < 0.01). The acute ITP group showed better scores in three dimensions including GH, energy/vitality, and RE than chronic ITP (P < 0.01). Meanwhile through classification with platelet count, three subgroups of patients also experienced significant differences in PF, GH, and SF from the eight dimensions. Age was a significant negative predictor of all eight dimensions other than the SF while current platelet count was a significant negative predictor of GH. Moreover, the treatment cost and family income also influenced the QoL scores. The subjective feeling of fear about bleeding had a detrimental impact on QoL. CONCLUSIONS: QoL was impaired in patients with ITP, especially in the acute patients. The platelet count and the feeling of fear about bleeding had a detrimental impact on QoL.     

Impact of osteoarthritis on quality of life in a Hong Kong Chinese population

OBJECTIVE: To measure the impact of osteoarthritis (OA) on quality of life in the Hong Kong Chinese population. METHODS: This was a cross sectional, retrospective, non-random, cohort design stratifying disease severity and presence or absence of joint prostheses. Patients with OA (n = 574; 136 men and 438 women) were recruited from rheumatology, family medicine, orthopedics, and geriatric medicine clinics. They were divided into 2 equal groups based upon disease severity (either American College of Rheumatology functional classes I and II, or III and IV). The 36-item Medical Outcomes Study Short-Form Health Survey (SF-36) and Western Ontario and McMaster Universities (WOMAC) OA Index were used. RESULTS: Patients with severe disease had lower mean scores in all SF-36 domains and higher mean scores in all WOMAC domains, indicating poorer quality of life. Scores in patients who had had arthroplasty were better than those with severe disease only in certain domains: role physical, general health, vitality, and mental health (SF-36); and pain (WOMAC). Women with OA had poorer scores compared to men for bodily pain, general health, and mental health after adjusting for age and disease severity. Low educational attainment was independently associated with poorer scores when disease severity was taken into account. CONCLUSION: OA has a significant impact on quality of life, only partly ameliorated by arthroplasty, as assessed by the SF-36 and WOMAC in this population.     

Body composition and clinical symptoms in patients with hip or knee osteoarthritis: Results from the KHOALA cohort

ObjectiveTo analyze the associations between body composition, notably low lean mass, and clinical symptoms [pain, physical function, quality of life (QoL)] in patients with symptomatic hip and/or knee OA.MethodsCross-sectional study using data from the 3-year follow-up visit of the Knee and Hip OsteoArthritis Long-term assessment (KHOALA) cohort. Skeletal muscle and fat mass were measured by dual X-ray absorptiometry (DXA). Fat mass index (FMI) was defined as total fat mass/height². Appendicular lean mass was adjusted on body mass index (ALM/BMI), and low lean mass was defined according to the definition of FNIH Sarcopenia Project recommendations. Pain and function were measured by the WOMAC index and QoL by the SF-36.ResultsIn total, 358 patients underwent DXA (67% women, mean [SD] age 63.4 [8.4] years, mean BMI 29.5 [5.6] kg/m²). The visual analog scale (0–100) pain score was 38.0 [24.7] and 25.4% had hip and 74.6% knee OA. Low lean mass and ALM/BMI were associated with impaired QoL and WOMAC scores on bivariate analysis (all p ≤ 0.001) but not on multivariate analysis after adjustment for FMI. For patients with normal BMI, mean [SD] WOMAC scores were higher (greater impairment) with low lean mass than normal body composition (WOMAC function 33.4 [23.3] and 24.0 [17.4], p = 0.02), and mean SF-36 physical component score was lower (greater impairment) 40.3 [10.2] and (44.3 [8.4], p = 0.04). Among patients with obesity, low lean mass had no additional effect.ConclusionFor patients with OA and normal BMI, QoL and function were more impaired for those with than without low lean mass. Conserving muscle mass in people with OA could have functional and antalgic benefits especially for those with normal BMI.     

Reliability and validity of the EuroQol in patients with osteoarthritis of the knee.

OBJECTIVE: To assess the reliability and validity of the EuroQol (EQ-5D) for osteoarthritis of the knee (OA knee). METHODS: Eighty-two patients with OA knee were asked to complete on two occasions, separated by 1 week, the EQ-5D, the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index and the 36-item short form of the Medical Outcomes Study (SF-36). RESULTS: In this patient population, < 10% of the 243 EQ-5D health states were active. The EQ-5D demonstrated a non-Gaussian distribution. Reliability [intraclass correlation coefficient (ICC) = 0.70] is acceptable for aggregate level data. There were significant rank correlations with both the WOMAC and SF-36. CONCLUSIONS: This study provides some evidence of EQ-5D construct validity and reliability. However, the restricted and non-normal distribution of scores, the marked difference between patients' self evaluation and derived societal utility tariffs, as well as the lack of discriminative ability for patients with 'moderate' morbidity within each of the five EQ-5D dimensions, are of concern.     

Validity, reliability, and comparison of the WOMAC osteoarthritis index and Lequesne algofunctional index in Turkish patients with hip or knee osteoarthritis

To assess validity and reliability of the Western Ontario and McMaster Universities (WOMAC) osteoarthritis (OA) index and Lequesne algofunctional index in Turkish patients with hip or knee OA and to compare the results of the instruments for these two particular sites of involvement. Two disease-specific instruments: WOMAC LK 3.1 and Lequesne indices were administered to 117 outpatients with OA (44 hip and 73 knee) living in Turkey. These indices were administered twice 7–10 days apart to ensure the test–retest reliability. All patients were asked to reply a generic health-related quality-of-life instrument (Short Form-36, SF-36) and a structured interview assessing demographic and other characteristics. Internal consistency and reliability was evaluated by Cronbach’s alpha and intra-class correlation coefficients (ICC). Construct validity was tested by correlating the WOMAC or Lequesne with each other, and also with SF-36 and visual analog scale (VAS). The Cronbach’s alphas of the WOMAC and Lequesne subscales were ranged 0.78–0.95 and 0.51–0.85 for hip and 0.78–0.94 and 0.61–0.71 for knee OA, respectively. Test–retest reliability of the WOMAC and Lequesne subscales yielded ICCs of 0.77–0.94 and 0.51–0.85 for hip and 0.80–0.98 and 0.61–0.71 for knee OA, respectively. WOMAC and Lequesne showed moderate-good correlations between comparable subscales of SF-36 (physical functioning and bodily pain) and weak-moderate correlations between VAS. All subscales and total WOMAC had better internal consistency and more satisfactory concurrent validity compared with Lequesne. Our results indicated that WOMAC is a more reliable index for use in Turkish patients with hip or knee OA than Lequesne.     

Age and waiting time as predictors of outcome after total hip replacement for osteoarthritis

OBJECTIVE: To investigate in a prospective study the relationship between age, pre-operative status, waiting time and post-operative outcome in patients assigned for unilateral total hip replacement (THR) due to osteoarthritis (OA). METHOD: One hundred and forty-eight patients (mean age 71 yr) with primary OA of the hip were investigated pre-operatively and 3, 6 and 12 months post-operatively with the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). For 56 of the patients an additional evaluation was made when they were placed on the waiting list. RESULTS: One hundred and twenty-four patients fulfilled the study criteria (age 50 yr or over and unilateral THR for OA during the study period). Before surgery there were no differences in the WOMAC or SF-36 subscales (except mental health) between patients aged over and under 72 yr. Post-operatively, the younger patients reached a better score than the older patients. There were no differences in pre-operative status or post-operative outcome between the patients who had been on the waiting list more than and less than 3 months. Most pain relief after hip replacement was obtained by 3 months, while it took at least 1 yr to reach the full benefit in improved function. Ninety per cent of the patients had improved by at least 10 points on a 100-point scale for pain and function at 12 months. CONCLUSION: The age of the patients assigned for THR did not determine their pre-operative status. However, younger patients gained more function post-operatively than older patients and reached higher absolute mean SF-36 values, except for pain. An average difference in time on the waiting list of 3 months did not result in a difference in post-operative outcome. At least 1 yr is required for the average OA patient to gain the full benefit of the THR.     

Topical diclofenac versus placebo: a double blind, randomized clinical trial in patients with osteoarthritis of the knee

OBJECTIVE: To assess the efficacy and safety of a topical formulation of 2% diclofenac in lecithin organogel in the treatment of pain associated with mild to moderate osteoarthritis (OA) of the knee. METHODS: Seventy patients completed a double blind, randomized, placebo controlled, parallel group design 2 week clinical trial. Patient responses to disease-specific (WOMAC VA3.0) and quality of life (Medical Outcome Survey SF-36) health status measures were assessed. Global assessments were also made at baseline and post-treatment. The physician conducted a global assessment and range of motion of the knee at baseline and post-treatment. RESULTS: T tests on the aggregated WOMAC total score and aggregated subscale scores revealed significant improvement (p<0.05) on the aggregated total score and the pain, stiffness, and physical function subscales from baseline to post-treatment for the active treatment group versus the placebo group. Analysis of gain scores from the aggregated WOMAC total score and aggregated subscale scores also revealed that this improvement was significantly greater than the improvement recorded by the placebo treatment group on the aggregated total and the pain and physical function subscale scores. Other efficacy measures exhibited no significant differences between or within treatment groups. CONCLUSION: A topical formulation of 2% diclofenac in a lecithin organogel appears to have therapeutic value in patients with mild to moderate OA of the knee as determined by responses from the WOMAC (VA3.0) osteoarthritis health status measure.     

Impact of musculoskeletal disorders on quality of life: an inception cohort study

OBJECTIVE: To assess longitudinally the impact of new onset musculoskeletal (MSK) disorders on quality of life (QoL). METHODS: An inception cohort of 1202 subjects in France aged 45-60 years was determined to be free of MSK problems at baseline. Over 28 months of follow up between 1996 and 1998, 310 were diagnosed with MSK disorders and matched for age and sex with 620 healthy controls. The impact of the MSK disorder onset on QoL was assessed by the change in SF-36 dimension scores over time, using a linear mixed ANOVA model to compare the groups. RESULTS: The incidence of MSK disorder was 13.6% per person-year in the spine, 4.2% per person-year in a joint, and 4.6% per person-year at an extra-articular site. The greatest change in QoL was a 10 point drop in the 100 point SF-36 bodily pain dimension scale in the MSK group. Compared with controls, subjects with an MSK disorder had significantly greater reductions in the following dimensions: bodily pain (a -7.4 point difference in change), vitality (-2.7), general health (-1.8), and physical functioning (-1.3). Within the MSK group, chronic disorders had a greater impact than acute ones on the physical functioning (-2.1), role emotional (-8.4), and social functioning (-5.9) dimensions. CONCLUSION: New onset MSK disorders have a marked deleterious effect on QoL in the physical domain, with lesser effects on social and mental functioning. This evidence of an early significant impact on their QoL reinforces recent recommendations for early treatment and primary prevention.     

Effect of rate or rhythm control on quality of life in persistent atrial fibrillation. Results from the Rate Control Versus Electrical Cardioversion (RACE) Study

OBJECTIVES: We studied the influence of rate control or rhythm control in patients with persistent atrial fibrillation (AF) on quality of life (QoL). BACKGROUND: Atrial fibrillation may cause symptoms like fatigue and dyspnea. This can impair QoL. Treatment of AF with either rate or rhythm control may influence QoL. METHOD: Quality of life was assessed in patients included in the Rate Control Versus Electrical Cardioversion for Persistent Atrial Fibrillation (RACE) study (rate vs. rhythm control in persistent AF). Rate control patients (n = 175) were given negative chronotropic drugs and oral anticoagulation. Rhythm control patients (n = 177) received serial electrocardioversion, antiarrhythmic drugs, and oral anticoagulation, as needed. Quality of life was studied using the Short Form (SF)-36 health survey questionnaire at baseline, one year, and the end of the study (after 2 to 3 years of follow-up). At baseline, QoL was compared with that of healthy control subjects. Patient characteristics related to QoL changes were determined. RESULTS: Mean follow-up was 2.3 years. At baseline, QoL was lower in patients than in age-matched healthy controls. At study end, under rate control, three subscales of the SF-36 improved. Under rhythm control, no significant changes occurred compared with baseline. At study end, QoL was comparable between both groups. The presence of complaints of AF at baseline, a short duration of AF, and the presence of sinus rhythm (SR) at the end of follow-up, rather than the assigned strategy, were associated with QoL improvement. CONCLUSIONS: Quality of life is impaired in patients with AF compared with healthy controls. Treatment strategy does not affect QoL. Patients with complaints related to AF, however, may benefit from rhythm control if SR can be maintained.     

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.