When ethics precludes randomization: put prospective, matched-pair observational studies to work.

Abstract:

:Randomized, controlled clinical trials (RCTs) may be possible, permissible, and practical in certain circumstances, but ethical or practical considerations often preclude their utilization. In many such cases, ethical objections will not apply to a similarly oriented, prospective, matched-pair observational study. Additionally, if the methodological rigor associated with the RCT is maintained, potential epistemic losses due to eliminating randomization will be mitigated. It is therefore suggested that when ethics precludes randomization, prospective, protocol-driven, matched-pair observational studies be put to work. One can also envision extending observational studies beyond their traditional time-dependent bounds to encompass never-ending activities focused on the accumulation of clinical knowledge in real-world settings.

journal_name

Perspect Biol Med

authors

Kowalski CJ

doi

10.1353/pbm.2013.0014

subject

Has Abstract

pub_date

2013-04-01 00:00:00

pages

184-97

issue

2

eissn

0031-5982

issn

1529-8795

pii

S1529879513200013

journal_volume

56

pub_type

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