The impact of adherence on sports injury prevention effect estimates in randomised controlled trials : Looking beyond the CONSORT statement
- Authors: Verhagen, Evert , Huuperans, Maarten , Finch, Caroline , van Mechelen, Willem
- Date: 2011
- Type: Text , Journal article
- Relation: Journal of Science and Medicine in Sport Vol. 14, no. 4 (July 2011 2011), p. 287-292
- Relation: http://purl.org/au-research/grants/nhmrc/565900
- Full Text: false
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- Description: Objective: To investigate estimated outcome effects of a sports injury prevention intervention when analysed by means of a per protocol (PP) analysis approach. Design: Randomised controlled trial (RCT) involving 522 athletes who sustained a lateral ankle sprain allocated to either an intervention (received a preventive programme in addition to usual care) or control group who were followed prospectively for one year. Methods: Secondary analysis of data relating to registered ankle sprain recurrences, exposure and adherence to the allocated intervention using a PP analysis approach. Results: Twenty-three percent of the RCT intervention group indicated to have fully adhered with the neuromuscular training programme. A per protocol analysis only considering fully adherent athletes and control athletes, showed a Hazard Ratio of 0.18 (95% CI: 0.07-0.43). Significantly fewer recurrent ankle sprains were found in the fully adherent group compared to the group that was not adherent (relative risk = 0.63; 95% CI: 0.43-0.99). Conclusions: A PP analysis on fully adherent athletes versus control group athletes showed that the established intervention effect was over threefold higher compared to an earlier intention-to-treat based analysis approach. This shows that outcomes of intervention studies are heavily biased by adherence to the allocated intervention.
Compliance with sport injury prevention interventions in randomised controlled trials : A systematic review
- Authors: van Reijen, Miriam , Vriend, Ingrid , van Mechelen, Willem , Finch, Caroline , Verhagen, Evert
- Date: 2016
- Type: Text , Journal article , Review
- Relation: Sports Medicine Vol. 46, no. 8 (2016), p. 1125-1139
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- Description: Introduction Sport injury prevention studies vary in the way compliance with an intervention is defined, measured and adjusted for. Objective The objective of this systematic review was to assess the extent to which sport injury prevention randomised controlled trials (RCTs) have defined, measured and adjusted results for compliance with an injury prevention intervention. Methods An electronic search was performed in MEDLINE, PubMed, the Cochrane Center of Controlled Trials, CINAHL (Cumulative Index to Nursing and Allied Health Literature), PEDro (Physiotherapy Evidence Database) and SPORTDiscus. English RCTs, quasi-RCTs and cluster-RCTs were considered eligible. Trials that involved physically active individuals or examined the effects of an intervention aimed at the prevention of sport-or physical activity-related injuries were included. Results Of the total of 100 studies included, 71.6 % mentioned compliance or a related term, 68.8 % provided details on compliance measurement and 51.4 % provided compliance data. Only 19.3 % analysed the effect of compliance rates on study outcomes. While studies used heterogeneous methods, pooled effects could not be presented. Conclusions Studies that account for compliance demonstrated that compliance significant affects study outcomes. The way compliance is dealt with in preventions studies is subject to a large degree of heterogeneity. Valid and reliable tools to measure and report compliance are needed and should be matched to a uniform definition of compliance.
Interventions preventing ankle sprains; previous injury and high-risk sport participation as predictors of compliance
- Authors: Janssen, Kasper , Van Der Zwaard, Babette , Finch, Caroline , van Mechelen, Willem , Verhagen, Evert
- Date: 2016
- Type: Text , Journal article
- Relation: Journal of Science and Medicine in Sport Vol. 19, no. 6 (Jun 2016), p. 465-469
- Full Text: false
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- Description: Objectives: To describe the association between participants' person-related potential predictor variables and cumulative compliance with interventions for preventing ankle sprains: neuromuscular training, wearing an ankle brace, and a combined training and bracing. Design: Secondary analysis of compliance data from a randomized controlled trial (RCT) comparing measures preventing ankle ligament injuries. Methods: Ordinal regression with a backward selection method was used to obtain a descriptive statistical model linking participants' person-related potential predictor variables with the monthly cumulative compliance measurements for three interventions preventing ankle ligament injuries. Results: Having had a previous ankle injury was significantly associated with a higher compliance with all of the preventive measures trialed. Overall compliance with bracing and the combined intervention was significantly lower than the compliance with NM training. Per group analysis found that participating in a high-risk sport, like soccer, basketball, and volleyball, was significantly associated with a higher compliance with bracing, or a combined bracing and NM training. In contrast, participating in a high-risk sport was significantly associated with a lower per group compliance with NM training. Conclusions: Future studies should include at least registration of previous ankle sprains, sport participation (high- or low-risk), experience in NM training, and hours of sport exposure as possible predictors of compliance with interventions preventing ankle sprains. Practitioners should take into account these variables when prescribing preventive neuromuscular training or bracing. (C) 2015 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.
Intervention strategies used in sport injury prevention studies : A systematic review identifying studies applying the Haddon matrix
- Authors: Vriend, Ingrid , Gouttebarge, Vincent , Finch, Caroline , van Mechelen, Willem , Verhagen, Evert
- Date: 2017
- Type: Text , Journal article , Review
- Relation: Sports Medicine Vol. 47, no. 10 (2017), p. 2027-2043
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- Description: Background: Prevention of sport injuries is crucial to maximise the health and societal benefits of a physically active lifestyle. To strengthen the translation and implementation of the available evidence base on effective preventive measures, a range of potentially relevant strategies should be considered. Objective: Our aim was to identify and categorise intervention strategies for the prevention of acute sport injuries evaluated in the scientific literature, applying the Haddon matrix, and identify potential knowledge gaps. Methods: Five electronic databases were searched (PubMed, EMBASE, SPORTDiscus, CINAHL, Cochrane) for studies that evaluated the effect of interventions on the occurrence of acute sport injuries. Studies were required to include a control group/condition, prospective data collection, and a quantitative injury outcome measure. Results: A total of 155 studies were included, mostly randomised controlled trials (43%). The majority of studies (55%) focussed on strategies requiring a behavioural change on the part of athletes. Studies predominantly evaluated the preventive effect of various training programmes targeted at the ‘pre-event’ phase (n = 73) and the use of equipment to avoid injury in the ‘event phase’ (n = 29). A limited number of studies evaluated the preventive effect of strategies geared at rules and regulations (n = 14), and contextual modifications (n = 18). Studies specifically aimed at preventing re-injuries were a minority (n = 8), and were mostly related to ankle sprains (n = 5). Conclusions: Valuable insight into the extent of the evidence base of sport injury prevention studies was obtained for 20 potential intervention strategies. This approach can be used to monitor potential gaps in the knowledge base on sport injury prevention. © 2017, The Author(s).