El Dib, Regina; Tikkinen, Kari A. O.; Akl, Elie A.; Gomaa, Huda A.; Mustafa, Reem A.; Agarwal, Arnav; Carpenter, Christopher R.; Zhang, Yuchen; Jorge, Eliane C.; Almeida, Ricardo A. M. B.; do Nascimento Junior, Paulo; Doles, Joao Vitor P.; Mustafa, Ahmad A.; Sadeghirad, Behnam; Lopes, Luciane C.; Bergamaschi, Cristiane C.; Suzumura, Erica A.; Cardoso, Marilia M. A.; Corrente, Jose Eduardo; Stone, Samuel B.; Schunemann, Holger J.; Guyatt, Gordon H.
(2017)
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. (C) 2017 Elsevier Inc. All rights reserved.