Validation of the General Health Questionnaire 12 for assessing psychological distress in patients with chronic low back pain.

BACKGROUND: The General Health Questionnaire 12 (GHQ-12) is a short easy-to-use scale to assess psychological distress. The GHQ-12 has not been validated for assessing psychological distress in patients with chronic low back pain (LBP). OBJECTIVE: To investigate the psychometric properties of the GHQ-12 in patients with chronic LBP. METHODS: The study involved a population of patients undergoing functional restoration for chronic LBP. The intraclass coefficient correlation was used for test-retest reliability (good if > 0.7) and the standard error measurement for absolute reliability. Construct validity was assessed with the Spearman correlation coefficient (moderate and high if r⩾ 0.35 and 0.5, respectively) and internal consistency with Cronbach's alpha (suitable if > 0.7). Responsiveness was assessed by the Wilcoxon test and effect size. RESULTS: Four hundred and five patients were included. The intraclass coefficient correlation was 0.73 and standard error measurement 2.49. The GHQ-12 showed high convergence with the Beck Depression Inventory and subscales of the Dallas Pain Questionnaire for anxiety and depression and for sociability. It showed moderate convergence with the Quebec Back Pain Disability Scale and subscales of the Dallas Pain Questionnaire for daily activities and for leisure and occupation. Cronbach's alpha was 0.89. The GHQ-12 score changed after functional restoration. It was lower (better) with than without improvement. CONCLUSIONS: We provide validation of the GHQ-12 for assessing psychological distress in patients with chronic LBP.

Unité Rhumatologique des Affections de la Main (URAM) scale: development and validation of a tool to assess Dupuytren's disease-specific disability.

OBJECTIVE: To our knowledge, no functional outcome measure has been developed and validated for Dupuytren's disease. We aimed to develop and validate a patient-reported functional outcome measure for Dupuytren's disease. METHODS: Patients with Dupuytren's disease (n = 9) and medical experts (n = 7) provided input and opinions about limiting activities that were difficult to perform because of Dupuytren's disease for item generation. The provisional scale was studied in an independent sample of patients (n = 85) for item reduction according to response distribution, reliability, redundancy, and loading in a 1-factor solution. The final scale was evaluated as follows: reliability using Cronbach's alpha coefficient and test-retest intraclass correlation coefficient from the previous 85-patient population, and construct validity and responsiveness after needle aponeurotomy in another independent 53-patient sample. For construct validity, convergent validity and divergent validity were tested. The clinically important change was estimated relative to a 1-point categorical change on the Tubiana scale. RESULTS: A 52-item provisional scale was generated and reduced to the final 9-item scale called the Unité Rhumatologique des Affections de la Main (URAM) scale (total score 0-45). The scale showed good to excellent reliability and suitable construct validity. The URAM score improved after needle aponeurotomy: the standardized effect size was 0.56. The estimated clinically important change of the URAM scale was 2.9 points. CONCLUSION: We provide the first patient-reported functional measure for Dupuytren's disease. The URAM scale demonstrated suitable psychometric properties, and is short and convenient enough for easy use in daily practice and in clinical studies.

Influence of patient education on exercise compliance in rheumatoid arthritis: a prospective 12-month randomized controlled trial.

OBJECTIVE: To determine the effect of education on the exercise habits of patients with rheumatoid arthritis (RA) after 6 and 12 months. METHODS: We studied 208 outpatients recruited between June 2001 and December 2002. This was a prospective controlled randomized trial. The active group received a multidisciplinary education program, including training in home-based exercises and guidelines for leisure physical activity (PA). The control group received a booklet added to usual medical care. Compliance with home-based exercises was defined as a practice rate >or= 30% of the prescribed training. Compliance with leisure PA was defined as >or= 20% increase in Baecke questionnaire score. Additional assessments involved possible predictors of compliance and changes with regard to the compliance. RESULTS: At 6-month followup, home-based exercise and leisure PA compliance were significantly higher [13.5% vs 1%, respectively (p = 0.001); and 28.2% vs 13.8% (p = 0.02)], but were not at 12 months. Predictors of leisure PA compliance at 6 months included participating in the active group (odds ratio 2.74, 95% CI 1.17 to 6.38) and previous low leisure PA (OR 6.01, 95% CI 2.47 to 14.61), with decreased fatigue (FACIT-F mean -2.94 +/- 8.04 vs -0.1 +/- 7.25 for noncompliant subjects; p = 0.04) and improved psychological status (Arthritis Impact Measurement Scale mean -1.25 +/- 3.12 vs 0.11 +/- 3.39; p = 0.03). CONCLUSION: Education of patients with RA may increase compliance especially with leisure PA, particularly when it is poor at baseline, but these effects are limited and short-term.

Effect of a collective educational program for patients with rheumatoid arthritis: a prospective 12-month randomized controlled trial.

OBJECTIVE: To evaluate the effect on health and functional status of an 8-week group-education program for rheumatoid arthritis (RA) in addition to usual medical care. METHODS: All consecutive inpatients and outpatients with RA (ACR criteria) were asked to participate in this randomized, prospective, controlled trial. The educational intervention consisted of 8 weekly ambulatory sessions, each lasting 6 hours. Followup was undertaken after 1 year. The primary criterion for judging effectiveness was the Health Assessment Questionnaire (HAQ) score; secondary criteria consisted of coping, medical knowledge, patient global satisfaction, and quality of life scores before the intervention and after 1 year. RESULTS: We asked 1242 inpatients and outpatients to participate in the study: 208 (16.75%) agreed (104 in each group). At baseline, there was no statistically significant difference between the 2 groups. After 1 year, no statistically significant difference was observed between the 2 groups in change in HAQ score: -0.04 +/- 0.46 (education group) vs -0.06 +/- 0.47 (control group) (p = 0.79). Statistically significant differences were found in 3 domains: patient coping (-1.22 +/- 5.55 vs -0.22 +/- 3.81; p = 0.03), knowledge (3.42 +/- 4.73 vs 0.73 +/- 3.78; p < 0.0001), and satisfaction (10.07 +/- 11.70 vs 5.72 +/- 13.77; p = 0.02), all of which were better for the group attending the education sessions. CONCLUSION: Despite improvements in patient coping, knowledge, and satisfaction, the education program was not found to be effective at 1 year. There may have been methodological problems relating to the sensitivity of questionnaires and patient selection, and tailored educational interventions should be considered.

Indications for lowering LDL cholesterol in rheumatoid arthritis: an unrecognized problem.

OBJECTIVE: To evaluate the prevalence of patients with rheumatoid arthritis (RA) in whom lowering low density lipoprotein cholesterol (LDL-C) should be considered in accord with the ATPIII guidelines. The treatment goals are based on the number of risk factors (RF) other than LDL-C. The goal for 0-1 RF is < 160 mg/l, for multiple RF < 130 mg/l, and < 100 mg/l for coronary heart disease (CHD) or CHD risk equivalent (other clinical atherosclerotic diseases and diabetes mellitus). METHODS: A cross-sectional study was conducted in 145 patients with RA. We recorded the patients' characteristics, the potential risk factors for CHD, and results of lipid profile tests [total cholesterol (TC), high density lipoprotein cholesterol, and LDL-C]. RESULTS: Of the 145 patients recruited, 23 had LDL-C lowering therapy. Of the remaining 122 patients (mean age 54 +/- 15 years), of whom 101 (83%) were women, 109 were taking a disease modifying antirheumatic drug. At the time of the study, disease duration was 12 +/- 10 years. Twenty-seven (22%) of the 122 patients needed lowering of LDL-C. If RA was considered as an additional risk factor or a major risk factor, like diabetes mellitus, 35 patients (29%) and 86 (70%) patients, respectively, needed lowering therapy. CONCLUSION: Our study shows the high percentage of patients with RA for whom LDL-C intervention should be considered. As cardiovascular morbidity and mortality is increased in patients with RA, it would be useful to determine whether RA should be considered as an independent cardiovascular risk factor or as a major risk factor like diabetes that warrants more aggressive cardiac prevention measures.

Which variables best predict change in rheumatoid arthritis therapy in daily clinical practice?

OBJECTIVE: To determine in clinical practice which clinical status variables for rheumatoid arthritis (RA) are most closely associated with a change in disease modifying antirheumatic drug (DMARD) therapy. METHODS: A prospective monocenter study was conducted in 204 consecutive patients with RA. Rheumatologists recorded patient characteristics, treatments, and disease activity data [tender and swollen joint count (28), morning stiffness, visual analog scale (VAS) for pain (0-100 mm), patient global assessment and physician global assessment, Westergren erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP)]. The rheumatologists decided whether or not to initiate or change treatment but were not informed that their decisions were part of the investigation. Logistic regression analysis was performed to evaluate which study variables best predict change in therapy. ROC analysis was used to obtain the cutoff value of the different composite indices (DAS28(ESR), DAS28(CRP), SDAI) for treatment change, as well as sensitivity and specificity. RESULTS: The variables that were predictive for a change in treatment were (in descending order): swollen joint count, morning stiffness, CRP, tender joint count, and patient global assessment. Composite index values associated with a decision to modify DMARD therapy were: DAS28(ESR) 4.2 (sensitivity 87%, specificity 70%); DAS28(CRP) 3.6 (sensitivity 86%, specificity 78%); and SDAI 15 (sensitivity 90%, specificity 86%). The discriminative ability of SDAI was better than that of DAS28(CRP) or DAS28(ESR). CONCLUSION: In our study, swollen joint count was the variable with the greatest weight, which explains the observed better performance of SDAI.

The use of glucosamine therapy in osteoarthritis.

Glucosamine products have been used extensively for the management of pain in osteoarthritis. This paper reviews the most recent clinical and experimental studies regarding its efficacy and safety. Although clinical trials include methodologic flaws and publication bias, glucosamine is likely an effective therapy for the symptomatic management of osteoarthritis. In turn, definite proof for chondromodulating effect requires well-conducted clinical trials. In North America, glucosamine is an over-the-counter dietary supplement and preparations made by different manufacturers may vary. There is also a need to standardize this therapy and allow practitioners to give patients suitable advice. An ongoing long-term clinical trial in the US will possibly permit to investigate the clinical relevance of these results and give appropriate recommendations.

The use of glucosamine therapy in osteoarthritis.

Glucosamine products have been used extensively for the management of pain in osteoarthritis. This paper reviews the most recent clinical and experimental studies regarding its efficacy and safety. Although clinical trials include methodologic flaws and publication bias, glucosamine is likely an effective therapy for the symptomatic management of osteoarthritis. In turn, definite proof for chondromodulating effect requires well-conducted clinical trials. In North America, glucosamine is an over-the-counter dietary supplement and preparations made by different manufacturers may vary. There is also a need to standardize this therapy and allow practitioners to give patients suitable advice. An ongoing long-term clinical trial in the US will possibly permit to investigate the clinical relevance of these results and give appropriate recommendations.