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OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of surgical interventions for osteoarthritis.

Abstract：

:To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For each challenge raised in the paper, we propose potential solutions. Enrollment poses challenges in maintaining investigator equipoise, managing conflict of interest and anticipating that patient preferences for specific treatments may reduce enrollment. Intervention design and implementation pose challenges relating to obsolescence, fidelity of intervention delivery, and adherence and crossover. Assessment and analysis raise questions regarding blinding and clustering of observations. This paper describes methodological problems in the design and conduct of surgical randomized trials and proposes strategies for addressing these challenges.

journal_name

Osteoarthritis Cartilage

journal_title

Osteoarthritis and cartilage

authors

Katz JN,Losina E,Lohmander LS

doi

10.1016/j.joca.2015.02.024

subject

Has Abstract

pub_date

2015-05-01 00:00:00

pages

798-802

issue

5

eissn

1063-4584

issn

1522-9653

pii

S1063-4584(15)00068-0

journal_volume

23

pub_type

杂志文章,评审

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