Article type
Year
Abstract
Background: Fibromyalgia is a syndrome characterized by chronic widespread pain for which no clear cause can be found. Approximately 2% of the general population in the USA, and 3% in Canada, suffers from fibromyalgia. Observational studies have found that 20% to 50% of people with fibromyalgia report that they are unable to work or that they can work only a few days per month, and 27% to 55% receive disability or social security payments. Despite the high proportion of patients with fibromyalgia that receive disability benefits, it is not known to what degree such patients are represented in clinical trials.
Objectives: To explore the degree to which patients in receipt of disability benefits are represented among trials of therapy for fibromyalgia.
Methods: We identified relevant randomized controlled trials, in any language, by a systematic search of CINAHL, EMBASE, MEDLINE, AHMED, HealthSTAR, PsychINFO, PapersFirst, ProceedingsFirst, and Cochrane Central Register of Controlled Trials (CENTRAL), from inception of the database to April 2011. Eligible trials met the following criteria: 1) random allocation of patients to an intervention or a control; 2) inclusion of patients presenting with fibromyalgia or a related condition. Teams of reviewers extracted data, independently and in duplicate from each eligible study, regarding whether patients receiving disability benefits had been enrolled.
Results: We identified 15,466 potentially eligible articles and retrieved 763 articles in full text; 292 articles proved eligible. We found that 47 of 292 trials (16%) explicitly considered disability benefit status; however, 58% (27 of 47) did so only as an exclusion criteria. Of the remaining 20 trials, 33% of patients enrolled (598 of 1788) were receiving disability benefits.
Conclusions: Most clinical trials exploring management of fibromyalgia do not explicitly report whether they enrolled patients in receipt of disability benefits. Of the minority that do, most use this feature as an exclusion criterion. The generalizability of treatment effects, reported by clinical trials of fibromyalgia, to patients receiving disability benefits is uncertain.
Objectives: To explore the degree to which patients in receipt of disability benefits are represented among trials of therapy for fibromyalgia.
Methods: We identified relevant randomized controlled trials, in any language, by a systematic search of CINAHL, EMBASE, MEDLINE, AHMED, HealthSTAR, PsychINFO, PapersFirst, ProceedingsFirst, and Cochrane Central Register of Controlled Trials (CENTRAL), from inception of the database to April 2011. Eligible trials met the following criteria: 1) random allocation of patients to an intervention or a control; 2) inclusion of patients presenting with fibromyalgia or a related condition. Teams of reviewers extracted data, independently and in duplicate from each eligible study, regarding whether patients receiving disability benefits had been enrolled.
Results: We identified 15,466 potentially eligible articles and retrieved 763 articles in full text; 292 articles proved eligible. We found that 47 of 292 trials (16%) explicitly considered disability benefit status; however, 58% (27 of 47) did so only as an exclusion criteria. Of the remaining 20 trials, 33% of patients enrolled (598 of 1788) were receiving disability benefits.
Conclusions: Most clinical trials exploring management of fibromyalgia do not explicitly report whether they enrolled patients in receipt of disability benefits. Of the minority that do, most use this feature as an exclusion criterion. The generalizability of treatment effects, reported by clinical trials of fibromyalgia, to patients receiving disability benefits is uncertain.