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

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

J Clin Epidemiol. 2017 Jan 04;:

Authors: El Dib R, Tikkinen KA, Akl EA, Goma HA, Mustafa RA, Agarwal A, Carpenter CR, Zhang Y, Jorge EC, Almeida RA, do Nascimento Junior P, Doles JV, Mustafa AA, Sadeghirad B, Lopes LC, Bergamaschi CC, Suzumura EA, Cardoso MM, Betini M, Corrente JE, Stone SB, Schunemann HJ, Guyatt GH

Abstract
OBJECTIVE: To provide a perspective on the current practice of randomized controlled 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 (QoL)/functional status (n=14; 13.6%); and on composite endpoints (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.

PMID: 28063913 [PubMed - as supplied by publisher]

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