TY - JOUR
T1 - Systematic survey of randomized trials evaluating the impact of alternative diagnostic strategies on patient-important outcomes
AU - El Dib, Regina
AU - Tikkinen, Kari A.O.
AU - Akl, Elie A.
AU - Gomaa, Huda A.
AU - Mustafa, Reem A.
AU - Agarwal, Arnav
AU - Carpenter, Christopher R.
AU - Zhang, Yuchen
AU - Jorge, Eliane C.
AU - Almeida, Ricardo A.M.B.
AU - do Nascimento Junior, Paulo
AU - Doles, Joao Vitor P.
AU - Mustafa, Ahmad A.
AU - Sadeghirad, Behnam
AU - Lopes, Luciane C.
AU - Bergamaschi, Cristiane C.
AU - Suzumura, Erica A.
AU - Cardoso, Marília M.A.
AU - Corrente, José Eduardo
AU - Stone, Samuel B.
AU - Schunemann, Holger J.
AU - Guyatt, Gordon H.
N1 - Publisher Copyright:
© 2017 Elsevier Inc.
PY - 2017/4
Y1 - 2017/4
N2 - 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.
AB - 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.
KW - Accuracy
KW - Alternative diagnostic strategies
KW - Clinical trials
KW - Diagnostic techniques and procedures
KW - Evidence-based medicine
KW - Patient outcome
UR - http://www.scopus.com/inward/record.url?scp=85011275785&partnerID=8YFLogxK
U2 - 10.1016/j.jclinepi.2016.12.009
DO - 10.1016/j.jclinepi.2016.12.009
M3 - Article
C2 - 28063913
AN - SCOPUS:85011275785
SN - 0895-4356
VL - 84
SP - 61
EP - 69
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
ER -