Diet and Exercise and Knee Pain in Patients With Osteoarthritis and Overweight or Obesity—Reply

In their comments about our recent article,1 Dr Fan and colleagues question the use of a completers-only vs an intention-to-treat analysis. A strict definition of the intention-to-treat principle in clinical trials states that all randomized participants are included in the statistical analyses and...

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Bibliographic Details
Published in:JAMA : the journal of the American Medical Association 2023-04, Vol.329 (15), p.1318-1319
Main Authors: Messier, Stephen P, Beavers, Daniel P
Format: Article
Language:English
Subjects:
Arthralgia - diet therapy
Arthralgia - etiology
Arthralgia - therapy
Body weight
Clinical trials
Diet
Exercise
Exercise Therapy
Humans
Obesity
Obesity - complications
Osteoarthritis
Osteoarthritis - complications
Osteoarthritis, Knee - complications
Osteoarthritis, Knee - diet therapy
Osteoarthritis, Knee - therapy
Overweight
Overweight - complications
Overweight - diet therapy
Overweight - therapy
Pain
Pain - etiology
Sensitivity analysis
Statistical analysis
Treatment Outcome
Citations: Items that this one cites
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Summary:In their comments about our recent article,1 Dr Fan and colleagues question the use of a completers-only vs an intention-to-treat analysis. A strict definition of the intention-to-treat principle in clinical trials states that all randomized participants are included in the statistical analyses and analyzed according to the treatment group to which they were randomly assigned, irrespective of their treatment and adherence to the protocol. Because some participants did not attend the follow-up visits (6, 12, or 18 months postrandomization), our analyses could not be defined as intention to treat. All other components of the intention-to-treat definition were upheld, and participants with incomplete follow-up data (ie, missing at only 1 or 2 follow-up visits) were considered completers and their outcomes were included in the primary analysis. Furthermore, a prespecified sensitivity analysis using multiple imputation for all randomized participants was included in the article's supplemental information and resulted in similar between-group differences in WOMAC pain scores. Both were statistically significant, and the differences between groups were of uncertain clinical importance. Our approach aligns with guidance published elsewhere.
ISSN:0098-7484
1538-3598
DOI:10.1001/jama.2023.2542