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Outcomes for patients with the same disease treated inside and outside of randomized trials : a systematic review and meta-analysis

journal contribution
posted on 06.12.2017, 00:00 by N Fernandes, D Bryant, J Riva, L Somerville, N Bhatnagar, L Griffith, M El-Rabbany, Crystal Kean, R Moyer
Background: It is unclear whether participation in a randomized controlled trial (RCT), irrespective of assigned treatment, is harmful or beneficial to participants. We compared outcomes for patients with the same diagnoses who did ("insiders") and did not ("outsiders") enter RCTs, without regard to the specific therapies received for their respective diagnoses. Methods: By searching the MEDLINE (1966-2010), Embase (1980-2010), CENTRAL (1960-2010) and PsycINFO (1880-2010) databases, we identified 147 studies that reported the health outcomes of "insiders" and a group of parallel or consecutive "outsiders" within the same time period. We prepared a narrative review and, as appropriate, meta-analyses of patients' outcomes. Results: We found no clinically or statistically significant differences in outcomes between "insiders" and "outsiders" in the 23 studies in which the experimental intervention was ineffective (standard mean difference in continuous outcomes -0.03, 95% conidence interval [CI] -0.1 to 0.04) or in the 7 studies in which the experimental intervention was effective and was received by both "insiders" and "outsiders" (mean difference 0.04, 95% CI -0.04 to 0.13). However, in 9 studies in which an effective intervention was received only by "insiders," the "outsiders" experienced significantly worse health outcomes (mean difference -0.36, 95% CI -0.61 to -0.12). Interpretation: We found no evidence to support clinically important overall harm or benefit arising from participation in RCTs. This conclusion refutes earlier claims that trial participants are at increased risk of harm.

History

Volume

186

Issue

16

Start Page

596

End Page

609

Number of Pages

14

eISSN

1488-2329

ISSN

0820-3946

Location

Canada

Publisher

Canadian Medical Association

Language

en-aus

Peer Reviewed

Yes

Open Access

No

External Author Affiliations

London Health Sciences Centre, Canada; McMaster University; School of Medical and Applied Sciences (2013- ); TBA Research Institute; University of Ottawa; University of Toronto; University of Western Ontario;

Era Eligible

Yes

Journal

Canadian medical association journal.

Exports