OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of surgical interventions for osteoarthritis.
(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:
https://lup.lub.lu.se/record/5456704
- author
- Katz, J N ; Losina, E and Lohmander, Stefan LU
- organization
- publishing date
- 2015
- 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
- 2016-04-01 11:00:40
- date last changed
- 2023-01-02 18:01:18
@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}}, doi = {{10.1016/j.joca.2015.02.024}}, volume = {{23}}, year = {{2015}}, }