title: Primer: assessing the efficacy and safety of nonpharmacologic treatments for chronic rheumatic diseases.
abstract: Nonpharmacologic treatments (including surgery, technical operation, rehabilitation, physiotherapy, education or the use of external technical devices) represent a wide range of treatments for chronic rheumatic disease. Randomized, controlled trials (RCTs) are recognized as the best method for avoiding bias in assessing nonpharmacologic treatments. Designs such as nonrandomized studies, cluster-randomized trials, patient-preference trials, modified Zelen-design trials, tracker trials and expertise-based RCTs could, however, be used to assess such treatments. Assessing nonpharmacologic treatments involves methodologic issues linked to difficulties associated with blinding, duration of the study, main outcomes of the study, difficulties associated with standardizing the intervention and the influence of health-care providers. Hence, these treatments cannot be assessed according to the standards used for pharmacologic treatments. As well, specific instruments such as A CheckList to Evaluate A Report of a NonPharmacological Trial (CLEAR NPT) should be used to assess the quality of reports in this field. Important reporting guidelines that take an evidence-based approach to improve the quality of reports from RCTs, such as the Consolidated Standards of Reporting Trials (CONSORT) statement, should be extended to take these issues into account.
authors.affiliation: University of Paris VII, Paris, France. philippe.ravaud@bch.aphp.fr
authors.forename: Philippe
authors.initials: P
authors.lastname: Ravaud
authors.forename: Isabelle
authors.initials: I
authors.lastname: Boutron
mesh_terms: D002908:Chronic Disease; D002986:Clinical Trials as Topic / Q000379:methods; D006801:Humans; D019637:Orthopedic Procedures / Q000379:methods*; D010353:Patient Education as Topic; D026741:Physical Therapy Modalities; D012216:Rheumatic Diseases / Q000628:therapy*; D016896:Treatment Outcome