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

作者：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

来源：Journal of Clinical Epidemiology, 2017, 84: 61-69.

DOI：10.1016/j.jclinepi.2016.12.009

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

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.

• 出版日期2017-4
• 单位Univ Estadual Paulista