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OARSI Clinical Trials Recommendations: Key analytic considerations in design, analysis, and reporting of randomized controlled trials in osteoarthritis.

Losina, E ; Ranstam, Jonas LU ; Collins, J E ; Schnitzer, T J and Katz, J N (2015) In Osteoarthritis and Cartilage 23(5). p.677-685
Abstract
To highlight methodologic challenges pertinent to design, analysis, and reporting of results of randomized clinical trials in OA and offer practical suggestions to overcome these challenges. The topics covered in this paper include subject selection, randomization, approaches to handling missing data, subgroup analysis, sample size, and issues related to changing design mid-way through the study. Special attention is given to standardizing the reporting of results and economic analyses. Key findings include the importance of blinding and concealment, the distinction between superiority and non-inferiority trials, the need to minimize missing data, and appropriate analysis and interpretation of subgroup effects. Investigators may use the... (More)
To highlight methodologic challenges pertinent to design, analysis, and reporting of results of randomized clinical trials in OA and offer practical suggestions to overcome these challenges. The topics covered in this paper include subject selection, randomization, approaches to handling missing data, subgroup analysis, sample size, and issues related to changing design mid-way through the study. Special attention is given to standardizing the reporting of results and economic analyses. Key findings include the importance of blinding and concealment, the distinction between superiority and non-inferiority trials, the need to minimize missing data, and appropriate analysis and interpretation of subgroup effects. Investigators may use the findings and recommendations advanced in this paper to guide design and conduct of randomized controlled trials of interventions for osteoarthritis. (Less)
Please use this url to cite or link to this publication:
author
; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Osteoarthritis and Cartilage
volume
23
issue
5
pages
677 - 685
publisher
Elsevier
external identifiers
  • pmid:25952341
  • wos:000353821200003
  • scopus:84933528472
  • pmid:25952341
ISSN
1063-4584
DOI
10.1016/j.joca.2015.03.011
language
English
LU publication?
yes
id
1f9d906f-f4e7-4038-9b38-ca8961a959db (old id 5456721)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/25952341?dopt=Abstract
date added to LUP
2016-04-01 10:54:32
date last changed
2022-02-17 22:29:33
@article{1f9d906f-f4e7-4038-9b38-ca8961a959db,
  abstract     = {{To highlight methodologic challenges pertinent to design, analysis, and reporting of results of randomized clinical trials in OA and offer practical suggestions to overcome these challenges. The topics covered in this paper include subject selection, randomization, approaches to handling missing data, subgroup analysis, sample size, and issues related to changing design mid-way through the study. Special attention is given to standardizing the reporting of results and economic analyses. Key findings include the importance of blinding and concealment, the distinction between superiority and non-inferiority trials, the need to minimize missing data, and appropriate analysis and interpretation of subgroup effects. Investigators may use the findings and recommendations advanced in this paper to guide design and conduct of randomized controlled trials of interventions for osteoarthritis.}},
  author       = {{Losina, E and Ranstam, Jonas and Collins, J E and Schnitzer, T J and Katz, J N}},
  issn         = {{1063-4584}},
  language     = {{eng}},
  number       = {{5}},
  pages        = {{677--685}},
  publisher    = {{Elsevier}},
  series       = {{Osteoarthritis and Cartilage}},
  title        = {{OARSI Clinical Trials Recommendations: Key analytic considerations in design, analysis, and reporting of randomized controlled trials in osteoarthritis.}},
  url          = {{http://dx.doi.org/10.1016/j.joca.2015.03.011}},
  doi          = {{10.1016/j.joca.2015.03.011}},
  volume       = {{23}},
  year         = {{2015}},
}