Systematic survey of randomized trials evaluating the impact of alternative diagnostic strategies on patient-important outcomes.

Autor: El Dib R; Department of Anaesthesiology, Botucatu Medical School, Unesp-Univ Estadual Paulista, Distrito de Rubião Júnior, s/n Univ Estadual Paulista, São Paulo 18618-970, Brazil; Department of Biosciences and Oral Diagnosis, Institute of Science and Technology, Unesp-Univ Estadual Paulista, Av. Eng. Francisco José Longo, 777 - Jardim Sao Dimas, São José dos Campos 12245-000, Brazil; McMaster Institute of Urology, McMaster University, St. Josephs Healthcare, 50 Charlton Ave E, Room G344, Hamilton, Ontario L8N 4A6, Canada. Electronic address: eldib@ict.unesp.br., Tikkinen KAO; Department of Urology, University of Helsinki and Helsinki University Hospital, Haartmaninkatu 4, Helsinki 00029, Finland., Akl EA; Department of Internal Medicine, American University of Beirut Medical Center, P.O. Box 11-0236, Riad-El-Solh, Beirut 1107 2020, Lebanon; Department of Health Research Methods, Evidence, and Impact (HEI), 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada., Gomaa HA; Department of Pharmacy, Tanta Chest Hospital, El Bahr St., Tanta, Gharbia 31527, Egypt., Mustafa RA; Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, HSC-3V43D 1200 Main Street West, Hamilton, Ontario L8N 3Z5, Canada; Department of Medicine, University of Missouri-Kansas City School of Medicine, M4-303, 2411 Holmes St., Kansas City, MO 64108-2792, USA., Agarwal A; School of Medicine, University of Toronto, 1 King's College Circle, Toronto, Ontario M5S 1A8, Canada., Carpenter CR; Department of Emergency Medicine, Washington University School of Medicine in St. Louis, Campus Box 8072, 660 S. Euclid Avenue, St. Louis, MO 63110, USA., Zhang Y; Department of Health Sciences, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada., Jorge EC; 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, São Paulo 18618-970, Brazil., Almeida RAMB; Department of Tropical Diseases and Imaging Diagnosis, Botucatu Medical School, Unesp-Univ Estadual Paulista, Distrito de Rubião Júnior, s/n Univ Estadual Paulista, São Paulo 18618-970, Brazil., do Nascimento Junior P; Department of Anaesthesiology, Botucatu Medical School, Unesp-Univ Estadual Paulista, Distrito de Rubião Júnior, s/n Univ Estadual Paulista, São Paulo 18618-970, Brazil., Doles JVP; Department of Anaesthesiology, Botucatu Medical School, Unesp-Univ Estadual Paulista, Distrito de Rubião Júnior, s/n Univ Estadual Paulista, São Paulo 18618-970, Brazil., Mustafa AA; School of Medicine, Jordan University of Science and Technology, P.O. Box 3030, Irbid 22110, Jordan., Sadeghirad B; Research Center for Modeling in Health, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran., Lopes LC; Pharmaceutical Science Graduate Course, University of Sorocaba, Rodovia Raposo Tavares, Km 92, 5, Sorocaba, Sao Paulo 18023-000, Brazil., Bergamaschi CC; Pharmaceutical Science Graduate Course, University of Sorocaba, Rodovia Raposo Tavares, Km 92, 5, Sorocaba, Sao Paulo 18023-000, Brazil., Suzumura EA; Research Institute, Hospital do Coração (HCor), Abílio Soares Street 250, 12th Floor, São Paulo 04005-000, Brazil., Cardoso MMA; Department of Anaesthesiology, Botucatu Medical School, Unesp-Univ Estadual Paulista, Distrito de Rubião Júnior, s/n Univ Estadual Paulista, São Paulo 18618-970, Brazil., Corrente JE; Biostatistics Department, Biosciences Institute, Unesp-Univ Estadual Paulista, Distrito de Rubião Júnior, s/n Univ Estadual Paulista, São Paulo 18618-970, Brazil., Stone SB; Family Medicine and CCFP [EM] Programmes, Northern Ontario School of Medicine, 955 Oliver Road, Thunder Bay, Ontario P7B 5E1, Canada., Schunemann HJ; Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, HSC-3V43D 1200 Main Street West, Hamilton, Ontario L8N 3Z5, Canada; Emergency Department, Health Sciences North, 41 Ramsey Lake Rd, Sudbury, Ontario P3E 5J1, Canada., Guyatt GH; Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, HSC-3V43D 1200 Main Street West, Hamilton, Ontario L8N 3Z5, Canada; Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4L8, Canada.
Jazyk: angličtina
Zdroj: Journal of clinical epidemiology [J Clin Epidemiol] 2017 Apr; Vol. 84, pp. 61-69. Date of Electronic Publication: 2017 Jan 04.
DOI: 10.1016/j.jclinepi.2016.12.009
Abstrakt: 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.
(Copyright © 2017 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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