How to define a Minimal Clinically Individual State (MCIS) with pain VAS in daily practice for patients suffering from musculoskeletal disorders.

OBJECTIVES: Pain is frequently the primary variable in symptomatic clinical trials for the evaluation of rheumatological disorders. The protocol of such trials mention a minimum level of pain as an entry criterion [e.g. a level above the Patient Acceptable Symptoms State (PASS)] and the changes in pain as the primary variable. Usually, the results are expressed at a group level as the mean changes in pain. However, the presentation at an individual level and, in particular, the percentage of patients with a Low Disease Activity State at the end of the study seems more clinically relevant. Pain is usually evaluated using a continuous variable such as a 0-100 visual analogue scale. The cut-offs permitting one to define both the entry criterion and the LDAS are not well established. The objective of this study was to evaluate such cut-offs using a patient-derived perspective. STUDY DESIGN: cross-sectional study. PATIENTS: consecutive out patients suffering from chronic rheumatic diseases familiar with the use of a VAS to evaluate their level of pain. DATA COLLECTED: two questions were asked the patients at the end of the visit: "Based on the experience you have because of your chronic rheumatic disorder, could you please specify the level of pain below which you consider your disease as inactive ? Moreover, could you please also specify the level of pain above which you consider taking a pain killer?" Before answering the second question, it was explained to the patient that their answer to the second question could be similar to their response to the first one. For the two questions, the cumulative percentage of patients (disease inactive and pain killer intake) were calculated for each level of pain. RESULTS: The underlying disease of the 137 evaluated patients (mean age: 57+/-16 and female sex: 76%) was rheumatoid arthritis (n = 59), ankylosing spondylitis (n = 19), SLE (n = 2), back pain (n = 20), or peripheral osteoarthritis (n = 37). The mean disease duration was 12+/-10 years. At the time of the study, the current level of pain evaluated on a 0-100 VAS was 33+/-22. The LDAS was 49, 36 and 25 for our patient population at the 25th, 50th and 75th percentiles, respectively. The pain killer intake level was 32, 48, 64 at the 25th, 50th, 75th percentile respectively. CONCLUSION: This study suggests that LDAS and PASS may be distinct concepts. The methodological approach adopted here could be of interest for specifying the minimum level of symptoms at entry in a symptomatic trial (PASS) and also to present results in terms of the percentage of patients in good condition (LDAS) at the end of a trial.

Assessment of fatigue in the management of patients with ankylosing spondylitis.

BACKGROUND: Pain, stiffness, functional impairment, range of motion and quality of life are the main conventional domains used in studies evaluating ankylosing spondylitis (AS). However, fatigue has been reported as the major complaint of AS patients. OBJECTIVES: To evaluate fatigue as a potential independent domain in comparison with the 'conventional' ones and to evaluate the sensitivity to change after non-steroidal anti-inflammatory drug (NSAID) therapy. METHODS: Patients were classified as having painful AS (modified New York criteria). The following variables were recorded at baseline and after 6 weeks of therapy (either placebo or NSAIDs): pain (VAS), function (Bath Ankylosing Spondylitis Functional Index), patient's global assessment (VAS), inflammation (night pain), morning stiffness, metrology (Schober test, finger-to-floor) and fatigue using 0-100 VAS scale. Analysis consisted of (i) the prevalence of fatigue (VAS value of at least 50 mm), (ii) the independence of the information evaluated using a regression model, and (iii) the sensitivity to change, by calculating the standardized response mean (mean change/s.d. change) (SRM) between placebo and NSAID group. RESULTS: Fatigue was considered important in 401 patients (out of 639: 63%). The information provided by the variables 'pain', 'function' and 'global assessment' explained only 44% of the variability of the variable 'fatigue' (similar analyses considering 'pain' on the one hand and 'function' on the other hand as the dependent variables showed an R2 value of 34 and 60%, respectively). The NSAID treatment effect (SRM) was higher for the variables 'pain' and 'function' (0.76 and 0.71, respectively) than for the variable 'fatigue' (0.34). CONCLUSION: This study strongly suggests that fatigue should be considered as an independent domain to be systematically evaluated in AS patients and that conventional therapy such as NSAIDs have a lower effect on this domain than on pain or functional impairment.

Primary glenohumeral degenerative joint disease: factors predisposing to arthroplasty.

OBJECTIVE: To evaluate the natural history of shoulder osteoarthritis (OA), in particular the requirement for arthroplasty over time, and to determine the potential predisposing factors for such arthroplasty. METHODS: In- and out-patients with the diagnosis of OA of the shoulder seen between January 1990 and December 1994 were contacted by mail or telephone in 2000. Evaluation at the time of diagnosis: demographics, clinical and radiological data were evaluated at the time of diagnosis. The follow-up evaluation consisted of a questionnaire sent to each patient inquiring whether they had had recourse to shoulder arthroplasty and, if not, evaluated their willingness regarding this surgical approach. For the statistical analysis the requirement for arthroplasty over time was evaluated using the Kaplan-Meier technique. Potential factors predisposing to arthroplasty were determined using a Cox-model analysis. RESULTS: The questionnaire was answered by 72 of the 86 contacted patients. No difference was observed in clinical and radiological variables at the time of diagnosis between responders and non-responders. The requirement for arthroplasty was low (respectively 5% and 13%, 5 and 10 years following the onset of the symptoms). Nearly half of the patients who had not undergone surgery thought that arthroplasty would have been the treatment of choice to improve their quality of life since more than one year at the time of completing the questionnaire. Two variables were picked up in the Cox analysis, with a probability of shoulder replacement higher in patients with concomitant osteonecrosis of the humeral head (p = 0.02) and a non-eccentric glenohumeral OA (p = 0.011). CONCLUSION: The low percentage of patients with arthroplasty over time, together with patient perception, suggest underuse of this surgical approach in shoulder OA.