Can clinical trials in rheumatology be improved? 1991

P S Blair, and A J Silman
Arthritis and Rheumatism Council Epidemiology Unit, University of Manchester, UK.

With our growing dependence on clinical trials to assess the adequacy of available treatments for arthritic patients, attention is increasingly being focused on the tools we use in the design, analysis, and reporting of these studies and the ways in which we can improve them. This review outlines some of the major problems in terms of patient compliance, trial size, inadequate endpoints, and insufficient reporting, and highlights some of the work being done to overcome these difficulties. The greatest emphasis is placed on two issues. Firstly, there is a need for greater stringency in interpreting the results. Thus, more consideration needs to be devoted to the limitations of the measurements used and greater emphasis needs to be placed on analysis on the basis of "intention to treat". Secondly, there is a need to standardize common aspects of the trials, such as the detailed reporting of baseline data, a minimal set of outcome measures, comparable response thresholds, and the inclusion of statistics such as confidence intervals. Implementing these changes will increase comparability and yield a stronger possibility of significant results.

UI MeSH Term Description Entries
D010043 Outcome and Process Assessment, Health Care Evaluation procedures that focus on both the outcome or status (OUTCOMES ASSESSMENT) of the patient at the end of an episode of care - presence of symptoms, level of activity, and mortality; and the process (ASSESSMENT, PROCESS) - what is done for the patient diagnostically and therapeutically. Outcome and Process Assessment (Health Care),Donabedian Model,Donabedian Triad,Outcome and Process Assessment,Structure Process Outcome Triad,Model, Donabedian,Triad, Donabedian
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D006302 Health Services Research The integration of epidemiologic, sociological, economic, and other analytic sciences in the study of health services. Health services research is usually concerned with relationships between need, demand, supply, use, and outcome of health services. The aim of the research is evaluation, particularly in terms of structure, process, output, and outcome. (From Last, Dictionary of Epidemiology, 2d ed) Health Care Research,Medical Care Research,Research, Health Services,Action Research,Health Services Evaluation,Healthcare Research,Research, Medical Care,Evaluation, Health Services,Evaluations, Health Services,Health Services Evaluations,Research, Action,Research, Health Care,Research, Healthcare
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D012216 Rheumatic Diseases Disorders of connective tissue, especially the joints and related structures, characterized by inflammation, degeneration, or metabolic derangement. Rheumatism,Disease, Rheumatic,Diseases, Rheumatic,Rheumatic Disease

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