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Considerations for high quality relevant data collection in large scale injury prevention randomised control trials
Abstracts / Journal of Science and Medicine in Sport 12 (2010) e1–e232
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example, it is now necessary to work within time and workload restrictions from coaches, players, and a timetable that is largely dictated by someone other than the researchers. Moreover, there are other factors that cannot also be controlled, such as the physical environment, player and coach attitudes and opinions, weather and other factors. In the case of implementing a training programme into community-level football teams through the “Preventing Australian Football Injuries through eXercise” (PAFIX) project, it was necessary that the programme incorporated exercises and principles that had been shown to work in the laboratory in both 6- and 12week training studies into a twenty-eight week periodised programme; that covers the entire season and 8 weeks of pre-season. Firstly, this required progressions of exercises that were achievable by a wide range of player abilities, upskilling of trainers to deliver those exercises and providing ongoing support to those trainers responsible for implementing the programmes. Secondly, a field test battery needed to be designed to provide surrogate measures of the more complicated laboratory procedures that were not possible to conduct in the field. Though a difficult task, this was achievable by using sound laboratory-based tests, evidence and findings and applying these in the field to track the changes that may occur as a result of the interventions being trialed.
tion forms and explicit guidelines on how to complete them were developed. Observational crosschecks of the recorded exposure and the number of game injuries were undertaken by independent assessors for every team at least once during the playing season. This data was then compared to that collected by the club-based primary data collectors to evaluate its case-capture and reliability. Following sound database management principles, all recorded data was double entered and checked to remove the possibility of data entry error by multiple individuals. Exposure data was checked weekly for missing players and followed up immediately to ensure no injuries were missed. Despite being a dual state project, all data were stored and entered into a single database in one state. Coding of injuries to the Orchard Sports Injury Classification System (OSICS) and identification of the relationship to neuromuscular mechanisms or ground conditions was undertaken by independent assessors and crosschecked for discrepancies. The principles of good database management, ensuring and assessing the reliability of data collected by club-based primary data collectors and achieving consistency in data by standardisation of tools and guidelines for using them in a dual state project are important lessons from the PAFIX study that should be used to uniform the design of future large scale prospective sports injury prevention studies.
doi:10.1016/j.jsams.2009.10.471
doi:10.1016/j.jsams.2009.10.472
471
472
Considerations for high quality relevant data collection in large scale injury prevention randomised control trials
Efficacy of exercise physiologist counselling in primary care patients: A pilot study to determine feasibility and acceptability
D. Twomey 1,∗ , C. Finch 1 , D. Lloyd 2 , B. Elliot 2 , T. Doyle 2 1 University
of Ballarat 2 University of Western Australia When undertaking large scale randomised control trials (RCTs), the accuracy and reliability of the data are vital to the success of the project. It is critical that all data collection tools and procedures are fully standardised and based on rigorous methodological approaches. This paper will describe the rationale for, development of, and administration of a range of data collection tools required to ensure accurate data in a large scale injury prevention RCT. The examples are drawn from the National Health and Medical Research Council (NHMRC) funded RCT “Preventing Australian Football Injuries through eXercise” (PAFIX) project, which collected data throughout the 2007 and 2008 playing seasons in community-level football in both Victoria and Western Australia. This RCT involved the implementation and evaluation of a training intervention to reduce lower limb injuries. Its outcomes were assessed by monitoring both game and training exposure (attendance, phase of play, and lower limb taping), injury surveillance (nature, casual and outcome factors), ground condition and compliance data (proportion of PAFIX program undertaken). Standardised data collec-
B. Ewald, E. James ∗ , N. Johnson, L. Paras University of Newcastle Introduction: GPs could play an important role in increasing population PA levels. While tools such as Lifescripts and the PA module in the clinical software Medical Director have been developed to assist GPs with this task, these do not circumvent most of the barriers to PA counselling identified by GPs. In contrast, referral of insufficiently active patients to an Exercise Physiologist (EP) for exercise coaching is a sustainable clinician initiated approach that would overcome most of the barriers. Therefore, research to determine the effectiveness of GP referral of insufficiently active adults to an EP is warranted. This pilot study tested the recruitment strategy and proposed project materials for a planned future RCT to ensure the feasibility and acceptability of the trial to GPs, practice nurses, receptionists, EPs and patients. Methodology: General Practices were recruited via the Local Division of GP and existing networks of GPs interested in research in Newcastle, NSW. Both sole practitioners and group practices were recruited. Patient recruitment was through a variety strategies, together with suggestion by GPs and practice nurses. Over two month periods we trialled
e225
example, it is now necessary to work within time and workload restrictions from coaches, players, and a timetable that is largely dictated by someone other than the researchers. Moreover, there are other factors that cannot also be controlled, such as the physical environment, player and coach attitudes and opinions, weather and other factors. In the case of implementing a training programme into community-level football teams through the “Preventing Australian Football Injuries through eXercise” (PAFIX) project, it was necessary that the programme incorporated exercises and principles that had been shown to work in the laboratory in both 6- and 12week training studies into a twenty-eight week periodised programme; that covers the entire season and 8 weeks of pre-season. Firstly, this required progressions of exercises that were achievable by a wide range of player abilities, upskilling of trainers to deliver those exercises and providing ongoing support to those trainers responsible for implementing the programmes. Secondly, a field test battery needed to be designed to provide surrogate measures of the more complicated laboratory procedures that were not possible to conduct in the field. Though a difficult task, this was achievable by using sound laboratory-based tests, evidence and findings and applying these in the field to track the changes that may occur as a result of the interventions being trialed.
tion forms and explicit guidelines on how to complete them were developed. Observational crosschecks of the recorded exposure and the number of game injuries were undertaken by independent assessors for every team at least once during the playing season. This data was then compared to that collected by the club-based primary data collectors to evaluate its case-capture and reliability. Following sound database management principles, all recorded data was double entered and checked to remove the possibility of data entry error by multiple individuals. Exposure data was checked weekly for missing players and followed up immediately to ensure no injuries were missed. Despite being a dual state project, all data were stored and entered into a single database in one state. Coding of injuries to the Orchard Sports Injury Classification System (OSICS) and identification of the relationship to neuromuscular mechanisms or ground conditions was undertaken by independent assessors and crosschecked for discrepancies. The principles of good database management, ensuring and assessing the reliability of data collected by club-based primary data collectors and achieving consistency in data by standardisation of tools and guidelines for using them in a dual state project are important lessons from the PAFIX study that should be used to uniform the design of future large scale prospective sports injury prevention studies.
doi:10.1016/j.jsams.2009.10.471
doi:10.1016/j.jsams.2009.10.472
471
472
Considerations for high quality relevant data collection in large scale injury prevention randomised control trials
Efficacy of exercise physiologist counselling in primary care patients: A pilot study to determine feasibility and acceptability
D. Twomey 1,∗ , C. Finch 1 , D. Lloyd 2 , B. Elliot 2 , T. Doyle 2 1 University
of Ballarat 2 University of Western Australia When undertaking large scale randomised control trials (RCTs), the accuracy and reliability of the data are vital to the success of the project. It is critical that all data collection tools and procedures are fully standardised and based on rigorous methodological approaches. This paper will describe the rationale for, development of, and administration of a range of data collection tools required to ensure accurate data in a large scale injury prevention RCT. The examples are drawn from the National Health and Medical Research Council (NHMRC) funded RCT “Preventing Australian Football Injuries through eXercise” (PAFIX) project, which collected data throughout the 2007 and 2008 playing seasons in community-level football in both Victoria and Western Australia. This RCT involved the implementation and evaluation of a training intervention to reduce lower limb injuries. Its outcomes were assessed by monitoring both game and training exposure (attendance, phase of play, and lower limb taping), injury surveillance (nature, casual and outcome factors), ground condition and compliance data (proportion of PAFIX program undertaken). Standardised data collec-
B. Ewald, E. James ∗ , N. Johnson, L. Paras University of Newcastle Introduction: GPs could play an important role in increasing population PA levels. While tools such as Lifescripts and the PA module in the clinical software Medical Director have been developed to assist GPs with this task, these do not circumvent most of the barriers to PA counselling identified by GPs. In contrast, referral of insufficiently active patients to an Exercise Physiologist (EP) for exercise coaching is a sustainable clinician initiated approach that would overcome most of the barriers. Therefore, research to determine the effectiveness of GP referral of insufficiently active adults to an EP is warranted. This pilot study tested the recruitment strategy and proposed project materials for a planned future RCT to ensure the feasibility and acceptability of the trial to GPs, practice nurses, receptionists, EPs and patients. Methodology: General Practices were recruited via the Local Division of GP and existing networks of GPs interested in research in Newcastle, NSW. Both sole practitioners and group practices were recruited. Patient recruitment was through a variety strategies, together with suggestion by GPs and practice nurses. Over two month periods we trialled