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

Katz, J N; Losina, E and Lohmander, Stefan LU (2015) In Osteoarthritis and Cartilage 23(5). p.798-802
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... (More)
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. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Osteoarthritis and Cartilage
volume
23
issue
5
pages
798 - 802
publisher
Elsevier
external identifiers
  • pmid:25952350
  • wos:000353821200012
  • scopus:84933500323
ISSN
1063-4584
DOI
10.1016/j.joca.2015.02.024
language
English
LU publication?
yes
id
f90b4c9c-21fc-44e7-9c8d-0120a37170fb (old id 5456704)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/25952350?dopt=Abstract
date added to LUP
2015-06-04 14:42:15
date last changed
2017-10-22 03:27:29
@article{f90b4c9c-21fc-44e7-9c8d-0120a37170fb,
  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.},
  author       = {Katz, J N and Losina, E and Lohmander, Stefan},
  issn         = {1063-4584},
  language     = {eng},
  number       = {5},
  pages        = {798--802},
  publisher    = {Elsevier},
  series       = {Osteoarthritis and Cartilage},
  title        = {OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of surgical interventions for osteoarthritis.},
  url          = {http://dx.doi.org/10.1016/j.joca.2015.02.024},
  volume       = {23},
  year         = {2015},
}