TY - JOUR AU - McAuley J. AU - Williams C. AU - Wolfenden L. AU - Kamper S. AU - Oldmeadow C. AU - Wiggers J. AU - O'Brien K. AU - Williams A. AU - Campbell E. AU - Yoong S. AU - Attia J. AB -

Background: These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. Method: These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. Conclusions: A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to.

AD - Hunter New England Population Health, Wallsend, NSW, Australia.
Hunter Medical Research Institute, Hunter Region Mc, NSW, Australia.
School of Medicine and Public Health, University of Newcastle (UON), Newcastle, Australia.
The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia.
Neuroscience Research Australia, Randwick, NSW, Australia. AN - 27683839 BT - Braz J Phys Ther CN - [IF]: 0.944 DP - NLM ET - 2016/09/30 LA - Eng LB - AUS
MSK
FY17 N1 - O'Brien, Kate M
Williams, Amanda
Wiggers, John
Wolfenden, Luke
Yoong, Serene
Campbell, Elizabeth
Kamper, Steven J
McAuley, James
Attia, John
Oldmeadow, Chris
Williams, Christopher M
Braz J Phys Ther. 2016 Sep 13:0. doi: 10.1590/bjpt-rbf.2014.0189. N2 -

Background: These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. Method: These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. Conclusions: A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to.

PY - 2016 SN - 1809-9246 (Electronic)
1413-3555 (Linking) T2 - Braz J Phys Ther TI - Effectiveness of a healthy lifestyle intervention for low back pain and osteoarthritis of the knee: protocol and statistical analysis plan for two randomised controlled trials Y2 - FY17 ER -