Effects of medical exercise therapy in patients with hip osteoarthritis: A randomized controlled trial with six months follow-up. A pilot study

2017 ◽  
Vol 21 (2) ◽  
pp. 284-289 ◽  
Author(s):  
Håvard Østerås ◽  
Fredrik Paulsberg ◽  
Stian Endré Olsen ◽  
Berit Østerås ◽  
Tom Arild Torstensen
Keyword(s):  
Randomized Controlled Trial ◽  
Pilot Study ◽  
Exercise Therapy ◽  
Controlled Trial ◽  
Hip Osteoarthritis ◽  
Randomized Controlled

Bayesian methods for pilot studies

2020 ◽  
Vol 17 (4) ◽  
pp. 414-419 ◽  
Author(s):  
Andrew R Willan ◽  
Lehana Thabane
Keyword(s):  
Randomized Controlled Trial ◽  
Pilot Study ◽  
Bayesian Methods ◽  
Controlled Trial ◽  
Recruitment Strategies ◽  
Pilot Studies ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Study Results

Background/aims: The use of pilot studies to help inform the design of randomized controlled trials has increased significantly over the last couple of decades. A pilot study can provide estimates of feasibility parameters, such as the recruitment, compliance and follow-up probabilities. The use of frequentist confidence intervals of these estimates fails to provide a meaningful measure of the uncertainty as it pertains to the design of the associated randomized controlled trial. The objective of this article is to introduce Bayesian methods for the analysis of pilot studies for determining the feasibility of an associated randomized controlled trial. Methods: An example from the literature is used to illustrate the advantages of a Bayesian approach for accounting for the uncertainty in pilot study results when assessing the feasibility of an associated randomized controlled trial. Vague beta distribution priors for the feasibility parameters are used. Based on the results from a feasibility study, simulation methods are used to determine the expected power of specified recruitment strategies for an associated randomized controlled trial. Results: The vague priors used for the feasibility parameters are demonstrated to be considerably robust. Beta distribution posteriors for the feasibility parameters lead to beta-binomial predictive distributions for an associated randomized controlled trial regarding the number of patients randomized, the number of patients who are compliant and the number of patients who complete follow-up. Ignoring the uncertainty in pilot study results can lead to inadequate power for an associated randomized controlled trial. Conclusion: Applying Bayesian methods to pilot studies’ results provides direct inference about the feasibility parameters and quantifies the uncertainty regarding the feasibility of an associated randomized controlled trial in an intuitive and meaningful way. Furthermore, Bayesian methods can identify recruitment strategies that yield the desired power for an associated randomized controlled trial.

Effects of 12 Weeks of Progressive Early Active Exercise Therapy After Surgical Rotator Cuff Repair: 12 Weeks and 1-Year Results From the CUT-N-MOVE Randomized Controlled Trial

2021 ◽  
Vol 49 (2) ◽  
pp. 321-331
Author(s):  
Birgitte Hougs Kjær ◽  
S. Peter Magnusson ◽  
Marius Henriksen ◽  
Susan Warming ◽  
Eleanor Boyle ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Rotator Cuff ◽  
Usual Care ◽  
Exercise Therapy ◽  
Controlled Trial ◽  
Rotator Cuff Tears ◽  
Full Thickness ◽  
Randomized Controlled ◽  
Secondary Outcomes

Background: Traumatic full-thickness rotator cuff tears are typically managed surgically, followed by rehabilitation, but the load progression to reach an optimal clinical outcome during postoperative rehabilitation is unknown. Purpose: To evaluate whether there was a superior effect of 12 weeks of progressive active exercise therapy on shoulder function, pain, and quality of life compared with usual care. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients with surgically repaired traumatic full-thickness rotator cuff tears were recruited from 2 orthopaedic departments and randomized to progressive active exercise therapy (PR) or limited passive exercise therapy (UC [usual care]). The primary outcome was the change in the Western Ontario Rotator Cuff Index (WORC) score between groups from before surgery to 12 weeks after surgery. Secondary outcomes included changes in the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire score, pain, range of motion, and strength. Adverse events were registered during the intervention period. Results: A total of 82 patients were randomized to the PR (n = 41) or UC (n = 41) group. All 82 patients (100%) participated in the 12-week assessment and 79 in the 1-year follow-up. At 12 weeks, there was no significant difference between the groups in the change in the WORC score from baseline adjusted for age, sex, and center (physical symptoms: P = .834; sports and recreation: P = .723; work: P = .541; lifestyle: P = .508; emotions: P = .568). Additionally, there was no between-group difference for the secondary outcomes including the WORC score at 1 year and the DASH score, pain, range of motion, and strength at 12 weeks and 1 year. Both groups showed significant improvements over time in all outcomes. In total, there were 13 retears (16%) at 1-year follow-up: 6 in the PR group and 7 in the UC group. Conclusion: PR did not result in superior patient-reported and objective outcomes compared with UC at either short- or long-term follow-up (12 weeks and 1 year). Registration: NCT02969135 ( ClinicalTrials.gov identifier)

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