Gro Jamtvedt, executive director Norwegian Knowledge Centre for the Health Services, Oslo, Norway, Robert D Herbert, Signe Flottorp, Jan Odgaard-Jensen, Kari Håvelsrud, Alex Barratt, Erin Mathieu, Amanda Burls, Andrew D Oxman
Send letter to journal:
Re: No discrepancy between protocol and trial report
grj{at}kunnskapssenteret.no Gro Jamtvedt, et al.
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We thank Professor Thornton for raising these issues and are grateful
for the opportunity to clarify details of the trial protocol and analysis.
There is, in fact, no discrepancy between the description of outcomes
in the trial protocol published on the trial web site, the protocol that
was registered on the Australian New Zealand Clinical Trials Registry, and
the report published in the British Journal of Sports Medicine. All three
sources describe the same primary outcomes (risk of soreness and time to
injury) and the same secondary outcomes (severity of soreness, time to
("preventable") muscle/ligament/tendon injuries, time to injuries for
which professional care was sought, and perceptions of looseness during
and after exercise). In addition, all three sources describe the same
secondary analyses of the interactions between frequency of activity, age
and strength of belief in affects of stretching and each of the two
primary outcomes. Confusion may have arisen because in the trial report we
refer to the analysis of the interactions as "outcomes", although the
analyses of interactions were conducted on the same primary and secondary
outcomes as listed above. And we may have added to the confusion by
inconsistently referring to the perceptions of looseness during and after
exercise as either one or two outcomes. We acknowledge that the wording
may not have been clear but we reiterate that there was no inconsistency
between the analyses described in the protocol, register and trial report.
The protocol, register and trial report describe an analysis of the
subset of injuries which could plausibly be prevented by stretching. The
protocol (which is more detailed than the registry entry) indicated that
the classification of injuries into those that could and could not
plausibly be prevented by stretching would be classified by an independent
expert. We found that the data lacked sufficient detail to inform
decisions about whether individual injuries were preventable so we decided
simply to classify all muscle, ligament and tendon injuries as potentially
preventable. This decision was made before the allocation code was broken
without reference to the data. We did not know, at the time that decision
was made, that there would be a significant effect of stretching on the
subset of muscle, ligament and tendon injuries.
As the protocol indicated, no adjustment was made for multiple
comparisons. We interpret frequentist analyses as Bayesian analyses with
vague priors[1] and, from this perspective, the decision not to make
adjustments for multiple comparisons is justified. At any rate, there were
only two primary outcomes so adjustment for multiple comparisons would not
have changed the conclusions from the primary analysis. We agree that the
finding of an effect on the secondary outcome of muscle, ligament and
tendon injuries is less robust than the finding of an effect on the
primary outcome risk of soreness because muscle, ligament and tendon
injuries were a secondary outcome. That is why we concluded that
stretching "probably reduces the risk of some injuries and does reduce the
risk of bothersome soreness".
Reference
1. Barnett V (1973). Comparative Statistical Inference. London:
Wiley.
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