Descrição
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Objectives To provide a perspective on the current practice of randomized clinical trials (RCTs) of diagnostic strategies focusing on patient-important outcomes. Study Design and Setting We conducted a comprehensive search of MEDLINE and included RCTs published in full-text reports that evaluated alternative diagnostic strategies. Results Of 56,912 unique citations, we sampled 7,500 and included 103 eligible RCTs, therefore suggesting that MEDLINE includes approximately 781 diagnostic RCTs. The 103 eligible trials reported on: mortality (n = 41; 39.8%); morbidities (n = 63; 61.2%); symptoms/quality of life/functional status (n = 14; 13.6%); and on composite end points (n = 10; 9.7%). Of the studies that reported statistically significant results (n = 12; 11.6%), we judged 7 (58.3%) as at low risk of bias with respect to missing outcome data and 4 (33.3%) as at low risk of bias regarding blinding. Of the 41 RCTs that reported on mortality, only one (2.4%) reported statistically significant results. Of 63 RCTs addressing morbidity outcomes, 11 (17.5%) reported statistically significant results, all of which reported relative effects of greater than 20%. Conclusion RCTs of diagnostic tests are not uncommon, and sometimes suggest benefits on patient-important outcomes but often suffer from limitations in sample size and conduct.
Department of Anaesthesiology Botucatu Medical School Unesp—Univ Estadual Paulista Distrito de Rubião Júnior s/n Univ Estadual Paulista
Department of Biosciences and Oral Diagnosis Institute of Science and Technology Unesp—Univ Estadual Paulista Av. Eng. Francisco José Longo 777 - Jardim Sao Dimas
McMaster Institute of Urology McMaster University, St. Josephs Healthcare, 50 Charlton Ave E, Room G344
Department of Urology University of Helsinki and Helsinki University Hospital, Haartmaninkatu 4
Department of Internal Medicine American University of Beirut Medical Center, P.O. Box 11-0236, Riad-El-Solh
Department of Health Research Methods Evidence and Impact (HEI), 1280 Main Street West
Department of Pharmacy Tanta Chest Hospital, El Bahr St.
Clinical Epidemiology and Biostatistics Faculty of Health Sciences, HSC-3V43D 1200 Main Street West
Department of Medicine University of Missouri-Kansas City School of Medicine, M4-303, 2411 Holmes St.
School of Medicine University of Toronto 1 King's College Circle
Department of Emergency Medicine Washington University School of Medicine in St. Louis, Campus Box 8072, 660 S. Euclid Avenue
Department of Health Sciences McMaster University, 1280 Main Street West
Department of Ophthalmology Otorhinolaryngology and Head and Neck Surgery Botucatu Medical School Unesp—Univ Estadual Paulista Distrito de Rubião Júnior s/n Univ Estadual Paulista
Department of Tropical Diseases and Imaging Diagnosis Botucatu Medical School Unesp—Univ Estadual Paulista Distrito de Rubião Júnior s/n Univ Estadual Paulista
School of Medicine Jordan University of Science and Technology, P.O. Box 3030
Research Center for Modeling in Health Institute for Futures Studies in Health Kerman University of Medical Sciences
Pharmaceutical Science Graduate Course University of Sorocaba Rodovia Raposo Tavares, Km 92, 5, Sorocaba
Research Institute Hospital do Coração (HCor), Abílio Soares Street 250, 12th Floor
Biostatistics Department Biosciences Institute Unesp—Univ Estadual Paulista Distrito de Rubião Júnior s/n Univ Estadual Paulista
Family Medicine and CCFP [EM] Programmes Northern Ontario School of Medicine, 955 Oliver Road
Emergency Department Health Sciences North 41 Ramsey Lake Rd
Department of Medicine McMaster University, 1280 Main Street West
Department of Anaesthesiology Botucatu Medical School Unesp—Univ Estadual Paulista Distrito de Rubião Júnior s/n Univ Estadual Paulista
Department of Biosciences and Oral Diagnosis Institute of Science and Technology Unesp—Univ Estadual Paulista Av. Eng. Francisco José Longo 777 - Jardim Sao Dimas
Department of Ophthalmology Otorhinolaryngology and Head and Neck Surgery Botucatu Medical School Unesp—Univ Estadual Paulista Distrito de Rubião Júnior s/n Univ Estadual Paulista
Department of Tropical Diseases and Imaging Diagnosis Botucatu Medical School Unesp—Univ Estadual Paulista Distrito de Rubião Júnior s/n Univ Estadual Paulista
Biostatistics Department Biosciences Institute Unesp—Univ Estadual Paulista Distrito de Rubião Júnior s/n Univ Estadual Paulista
