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

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OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of surgical interventions for osteoarthritis. / Katz, J N; Losina, E; Lohmander, Stefan.

In: Osteoarthritis and Cartilage, Vol. 23, No. 5, 2015, p. 798-802.

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TY - JOUR

T1 - OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of surgical interventions for osteoarthritis.

AU - Katz, J N

AU - Losina, E

AU - Lohmander, Stefan

PY - 2015

Y1 - 2015

N2 - 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.

AB - 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.

U2 - 10.1016/j.joca.2015.02.024

DO - 10.1016/j.joca.2015.02.024

M3 - Review article

VL - 23

SP - 798

EP - 802

JO - Osteoarthritis and Cartilage

T2 - Osteoarthritis and Cartilage

JF - Osteoarthritis and Cartilage

SN - 1063-4584

IS - 5

ER -