Randomised controlled trials (RCTs) in sports injury research: Authors - Please report the compliance with the intervention

Rasmus Oestergaard Nielsen, Michael Lejbach Bertelsen, Daniel Ramskov, Camma Damsted, Evert Verhagen, Steef W. Bredeweg, Daniel Theisen, Laurent Malisoux

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background: In randomised controlled trials (RCTs) of interventions that aim to prevent sports injuries, the intention-to-treat principle is a recommended analysis method and one emphasised in the Consolidated Standards of Reporting Trials (CONSORT) statement that guides quality reporting of such trials. However, an important element of injury prevention trials - compliance with the intervention - is not always well-reported. The purpose of the present educational review was to describe the compliance during follow-up in eight large-scale sports injury trials and address compliance issues that surfaced. Then, we discuss how readers and researchers might consider interpreting results from intention-to-treat analyses depending on the observed compliance with the intervention. Methods: Data from seven different randomised trials and one experimental study were included in the present educational review. In the trials that used training programme as an intervention, we defined full compliance as having completed the programme within ±10% of the prescribed running distance (ProjectRun21 (PR21), RUNCLEVER, Start 2 Run) or time-spent-running in minutes (Groningen Novice Running (GRONORUN)) for each planned training session. In the trials using running shoes as the intervention, full compliance was defined as wearing the prescribed running shoe in all running sessions the participants completed during follow-up. Results: In the trials that used a running programme intervention, the number of participants who had been fully compliant was 0 of 839 (0%) at 24-week follow-up in RUNCLEVER, 0 of 612 (0%) at 14-week follow-up in PR21, 12 of 56 (21%) at 4-week follow-up in Start 2 Run and 8 of 532 (1%) at 8-week follow-up in GRONORUN. In the trials using a shoe-related intervention, the numbers of participants who had been fully compliant at the end of follow-up were 207 of 304 (68%) in the 21 week trial, and 322 of 423 (76%), 521 of 577 (90%), 753 of 874 (86%) after 24-week follow-up in the other three trials, respectively. Conclusion: The proportion of runners compliant at the end of follow-up ranged from 0% to 21% in the trials using running programme as intervention and from 68% to 90% in the trials using running shoes as intervention. We encourage sports injury researchers to carefully assess and report the compliance with intervention in their articles, use appropriate analytical approaches and take compliance into account when drawing study conclusions. In studies with low compliance, G-estimation may be a useful analytical tool provided certain assumptions are met.
Original languageEnglish
JournalBritish journal of sports medicine
Volume54
DOIs
Publication statusPublished - 1 Jan 2020
Externally publishedYes

Cite this

Nielsen, Rasmus Oestergaard ; Bertelsen, Michael Lejbach ; Ramskov, Daniel ; Damsted, Camma ; Verhagen, Evert ; Bredeweg, Steef W. ; Theisen, Daniel ; Malisoux, Laurent. / Randomised controlled trials (RCTs) in sports injury research: Authors - Please report the compliance with the intervention. In: British journal of sports medicine. 2020 ; Vol. 54.
@article{3236d9a6a11e4a1e836ef22e82581047,
title = "Randomised controlled trials (RCTs) in sports injury research: Authors - Please report the compliance with the intervention",
abstract = "Background: In randomised controlled trials (RCTs) of interventions that aim to prevent sports injuries, the intention-to-treat principle is a recommended analysis method and one emphasised in the Consolidated Standards of Reporting Trials (CONSORT) statement that guides quality reporting of such trials. However, an important element of injury prevention trials - compliance with the intervention - is not always well-reported. The purpose of the present educational review was to describe the compliance during follow-up in eight large-scale sports injury trials and address compliance issues that surfaced. Then, we discuss how readers and researchers might consider interpreting results from intention-to-treat analyses depending on the observed compliance with the intervention. Methods: Data from seven different randomised trials and one experimental study were included in the present educational review. In the trials that used training programme as an intervention, we defined full compliance as having completed the programme within ±10{\%} of the prescribed running distance (ProjectRun21 (PR21), RUNCLEVER, Start 2 Run) or time-spent-running in minutes (Groningen Novice Running (GRONORUN)) for each planned training session. In the trials using running shoes as the intervention, full compliance was defined as wearing the prescribed running shoe in all running sessions the participants completed during follow-up. Results: In the trials that used a running programme intervention, the number of participants who had been fully compliant was 0 of 839 (0{\%}) at 24-week follow-up in RUNCLEVER, 0 of 612 (0{\%}) at 14-week follow-up in PR21, 12 of 56 (21{\%}) at 4-week follow-up in Start 2 Run and 8 of 532 (1{\%}) at 8-week follow-up in GRONORUN. In the trials using a shoe-related intervention, the numbers of participants who had been fully compliant at the end of follow-up were 207 of 304 (68{\%}) in the 21 week trial, and 322 of 423 (76{\%}), 521 of 577 (90{\%}), 753 of 874 (86{\%}) after 24-week follow-up in the other three trials, respectively. Conclusion: The proportion of runners compliant at the end of follow-up ranged from 0{\%} to 21{\%} in the trials using running programme as intervention and from 68{\%} to 90{\%} in the trials using running shoes as intervention. We encourage sports injury researchers to carefully assess and report the compliance with intervention in their articles, use appropriate analytical approaches and take compliance into account when drawing study conclusions. In studies with low compliance, G-estimation may be a useful analytical tool provided certain assumptions are met.",
author = "Nielsen, {Rasmus Oestergaard} and Bertelsen, {Michael Lejbach} and Daniel Ramskov and Camma Damsted and Evert Verhagen and Bredeweg, {Steef W.} and Daniel Theisen and Laurent Malisoux",
year = "2020",
month = "1",
day = "1",
doi = "10.1136/bjsports-2019-100858",
language = "English",
volume = "54",
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issn = "1473-0480",

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Randomised controlled trials (RCTs) in sports injury research: Authors - Please report the compliance with the intervention. / Nielsen, Rasmus Oestergaard; Bertelsen, Michael Lejbach; Ramskov, Daniel; Damsted, Camma; Verhagen, Evert; Bredeweg, Steef W.; Theisen, Daniel; Malisoux, Laurent.

In: British journal of sports medicine, Vol. 54, 01.01.2020.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Randomised controlled trials (RCTs) in sports injury research: Authors - Please report the compliance with the intervention

AU - Nielsen, Rasmus Oestergaard

AU - Bertelsen, Michael Lejbach

AU - Ramskov, Daniel

AU - Damsted, Camma

AU - Verhagen, Evert

AU - Bredeweg, Steef W.

AU - Theisen, Daniel

AU - Malisoux, Laurent

PY - 2020/1/1

Y1 - 2020/1/1

N2 - Background: In randomised controlled trials (RCTs) of interventions that aim to prevent sports injuries, the intention-to-treat principle is a recommended analysis method and one emphasised in the Consolidated Standards of Reporting Trials (CONSORT) statement that guides quality reporting of such trials. However, an important element of injury prevention trials - compliance with the intervention - is not always well-reported. The purpose of the present educational review was to describe the compliance during follow-up in eight large-scale sports injury trials and address compliance issues that surfaced. Then, we discuss how readers and researchers might consider interpreting results from intention-to-treat analyses depending on the observed compliance with the intervention. Methods: Data from seven different randomised trials and one experimental study were included in the present educational review. In the trials that used training programme as an intervention, we defined full compliance as having completed the programme within ±10% of the prescribed running distance (ProjectRun21 (PR21), RUNCLEVER, Start 2 Run) or time-spent-running in minutes (Groningen Novice Running (GRONORUN)) for each planned training session. In the trials using running shoes as the intervention, full compliance was defined as wearing the prescribed running shoe in all running sessions the participants completed during follow-up. Results: In the trials that used a running programme intervention, the number of participants who had been fully compliant was 0 of 839 (0%) at 24-week follow-up in RUNCLEVER, 0 of 612 (0%) at 14-week follow-up in PR21, 12 of 56 (21%) at 4-week follow-up in Start 2 Run and 8 of 532 (1%) at 8-week follow-up in GRONORUN. In the trials using a shoe-related intervention, the numbers of participants who had been fully compliant at the end of follow-up were 207 of 304 (68%) in the 21 week trial, and 322 of 423 (76%), 521 of 577 (90%), 753 of 874 (86%) after 24-week follow-up in the other three trials, respectively. Conclusion: The proportion of runners compliant at the end of follow-up ranged from 0% to 21% in the trials using running programme as intervention and from 68% to 90% in the trials using running shoes as intervention. We encourage sports injury researchers to carefully assess and report the compliance with intervention in their articles, use appropriate analytical approaches and take compliance into account when drawing study conclusions. In studies with low compliance, G-estimation may be a useful analytical tool provided certain assumptions are met.

AB - Background: In randomised controlled trials (RCTs) of interventions that aim to prevent sports injuries, the intention-to-treat principle is a recommended analysis method and one emphasised in the Consolidated Standards of Reporting Trials (CONSORT) statement that guides quality reporting of such trials. However, an important element of injury prevention trials - compliance with the intervention - is not always well-reported. The purpose of the present educational review was to describe the compliance during follow-up in eight large-scale sports injury trials and address compliance issues that surfaced. Then, we discuss how readers and researchers might consider interpreting results from intention-to-treat analyses depending on the observed compliance with the intervention. Methods: Data from seven different randomised trials and one experimental study were included in the present educational review. In the trials that used training programme as an intervention, we defined full compliance as having completed the programme within ±10% of the prescribed running distance (ProjectRun21 (PR21), RUNCLEVER, Start 2 Run) or time-spent-running in minutes (Groningen Novice Running (GRONORUN)) for each planned training session. In the trials using running shoes as the intervention, full compliance was defined as wearing the prescribed running shoe in all running sessions the participants completed during follow-up. Results: In the trials that used a running programme intervention, the number of participants who had been fully compliant was 0 of 839 (0%) at 24-week follow-up in RUNCLEVER, 0 of 612 (0%) at 14-week follow-up in PR21, 12 of 56 (21%) at 4-week follow-up in Start 2 Run and 8 of 532 (1%) at 8-week follow-up in GRONORUN. In the trials using a shoe-related intervention, the numbers of participants who had been fully compliant at the end of follow-up were 207 of 304 (68%) in the 21 week trial, and 322 of 423 (76%), 521 of 577 (90%), 753 of 874 (86%) after 24-week follow-up in the other three trials, respectively. Conclusion: The proportion of runners compliant at the end of follow-up ranged from 0% to 21% in the trials using running programme as intervention and from 68% to 90% in the trials using running shoes as intervention. We encourage sports injury researchers to carefully assess and report the compliance with intervention in their articles, use appropriate analytical approaches and take compliance into account when drawing study conclusions. In studies with low compliance, G-estimation may be a useful analytical tool provided certain assumptions are met.

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UR - https://www.ncbi.nlm.nih.gov/pubmed/31511232

U2 - 10.1136/bjsports-2019-100858

DO - 10.1136/bjsports-2019-100858

M3 - Article

VL - 54

JO - BJSM Online

JF - BJSM Online

SN - 1473-0480

ER -