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

Regina El Dib, Kari A.O. Tikkinen, Elie A. Akl, Huda A. Gomaa, Reem A. Mustafa, Arnav Agarwal, Christopher R. Carpenter, Yuchen Zhang, Eliane C. Jorge, Ricardo A.M.B. Almeida, Paulo do Nascimento Junior, Joao Vitor P. Doles, Ahmad A. Mustafa, Behnam Sadeghirad, Luciane C. Lopes, Cristiane C. Bergamaschi, Erica A. Suzumura, Marília M.A. Cardoso, José Eduardo Corrente, Samuel B. StoneHolger J. Schunemann, Gordon H. Guyatt

Research output: Contribution to journalArticlepeer-review

18 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)61-69
Number of pages9
JournalJournal of Clinical Epidemiology
Volume84
DOIs
StatePublished - Apr 2017

Keywords

  • Accuracy
  • Alternative diagnostic strategies
  • Clinical trials
  • Diagnostic techniques and procedures
  • Evidence-based medicine
  • Patient outcome

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