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

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 eva...

Full description

Saved in:

Bibliographic Details
Published in:	Journal of clinical epidemiology Vol. 84; pp. 61 - 69
Main Authors:	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, Marília M.A, Corrente, José Eduardo, Stone, Samuel B, Schunemann, Holger J, Guyatt, Gordon H
Format:	Journal Article
Language:	English
Published:	United States Elsevier Inc 01-04-2017 Elsevier Limited
Subjects:	Accuracy Alternative diagnostic strategies Bias Clinical trials Coma Diagnostic systems Diagnostic techniques and procedures Diagnostic tests Diagnostic Tests, Routine - statistics & numerical data Epidemiology Evidence-based medicine Humans Internal Medicine Laboratories Lung cancer Medical diagnosis Medical imaging Medical research MEDLINE Morbidity Mortality Patient outcome Patient Outcome Assessment Patients Poisoning Quality of life Randomization Randomized Controlled Trials as Topic - statistics & numerical data Statistical analysis Statistical significance Ultrasonic imaging Websites Clinical trials Accuracy Diagnostic techniques and procedures Alternative diagnostic strategies Patient outcome Evidence-based medicine
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
Summary:	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.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-3 content type line 23 ObjectType-Review-1
ISSN:	0895-4356 1878-5921
DOI:	10.1016/j.jclinepi.2016.12.009