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Abstract Background Intimate Partner Violence (IPV) is a major health issue that involves any physical, sexual or psychological harm inflicted by a current or former partner. Musculoskeletal injuries represent the second most prevalent clinical manifestation of IPV. Health care professionals, however, rarely screen women for IPV. Using qualitative methods, this study aimed to explore the perceived barriers to IPV screening and potential facilitators for overcoming these barriers among orthopaedic surgeons and surgical trainees. Methods We conducted three focus groups with orthopaedic surgeons, senior surgical trainees, and junior surgical trainees. A semi-structured focus group guide was used to structure the discussions. Transcripts and field notes from the focus groups were analyzed using the qualitative software program N'Vivo (version 10.0; QSR International, Melbourne, Australia). To further inform our focus group findings and discuss policy changes, we conducted interviews with two opinion leaders in the field of orthopaedics. Similar to the focus groups, the interviews were digitally recorded and transcribed, and then analyzed. Results In the analysis, four categories of barriers were identified: surgeon perception barriers; perceived patient barriers; fracture clinic barriers and orthopaedic health care professional barriers. Some of the facilitators identified included availability of a crisis team; development of a screening form; presence of IPV posters or buttons in the fracture clinic; and the need for established policy or government support for IPV screening. The interviewees identified the need for: the introduction of evidence-based policy aiming to increase awareness about IPV among health care professionals working within the fracture clinic setting, fostering local and national champions for IPV screening, and the need to generate change on a local level. Conclusions There are a number of perceived barriers to screening women in the fracture clinic for IPV, many of which can be addressed through increased education and training, and additional resources in the fracture clinic. Orthopaedic health care professionals are supportive of implementing an IPV screening program in the orthopaedic fracture clinic.

IntroductionPragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow.MethodsGiven the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients.Results7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p < 0.001).ConclusionsImplementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.

IntroductionCluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent.MethodsThe PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have.ResultsPatient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation.DiscussionInvolvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.

IntroductionCluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent.MethodsThe PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have.ResultsPatient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation.DiscussionInvolvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.