Jodi L. Gallant

Femoral shaft fractures are common severe injuries that carry an elevated risk of operative complications, including femoral malrotation, neurologic, and v

Background: Clinical trial participants have a right to know the results of the trials in which they participate. Trial results are often not shared directly with participants and concerns with privacy and resource constraints may prevent researchers from contacting participants after trial completion. Questions/Purposes: The objectives of this cross-sectional study were to explore the feasibility of contacting orthopaedic fracture trial participants after trial completion and to determine the preferences and priorities of the participants who wished to know the results. Patients/Methods: Following the publication of the primary manuscript, we attempted to contact participants from the completed PREPARE trial at Hamilton Health Sciences to determine if they would like to know the trial results. We asked participants about their preferences for receiving trial results, their experiences upon learning them, and if they wished to learn which treatment they received. Results: Twenty-eight percent (181/641) of PREPARE trial participants contacted agreed to participate in this study. We found that 95.5% (95% CI 91.0%—97.9%) of respondents wished to know the trial results and the preferred method was through viewing summary posters via an online link (78.2%; 95% CI 71.1%—84.0%). Most felt satisfied after learning the trial results (67.8%; 95% CI 59.5%- 75.2%) and 82.2% (95% CI 75.2%—87.5%) wanted to know which treatment they received. Fifty-one percent (95% CI 42.7%—58.7%) reported that learning the results increased their likelihood of participating in a future trial. Conclusions: Although it was challenging to both contact and re-engage participants after completing an orthopaedic trial that involved minimal participant burden, our study findings suggest that learning the trial results may have a positive impact on individual participants and the research community. Given the limited understanding of results among our respondents, researchers should have processes in place to engage participants meaningfully throughout the trial and proactively discuss with them how the results will be shared once the trial is complete. Level of evidence: IV.

Background: This prospective cohort study determined the prevalence of intimate partner violence (IPV) across gender groups, investigated timing of disclosures during the standard-of-care follow-up period, and examined if there was an association between IPV and clinical outcomes. Methods: This study included 314 patients ≥18 years of age presenting with orthopaedic injuries to the fracture clinics at 2 academic hospitals. Participants were asked about experiences with IPV, return to function, and overall health at each routine clinical follow-up. Cox proportional-hazards regression models were used to explore associations between IPV status and return to work, leisure activities, home responsibilities, and overall functioning. Results: Of the 528 patients approached, 314 provided consent and completed at least the initial visit. Of these, 184 (58.6%) self-identified as women, 126 (40.1%) identified as men, and 3 (1.0%) self-identified as non-binary. Forty-six percent of women reported lifetime experience of IPV, compared with 35% of men and 100% of gender-diverse participants. A smaller proportion of men who disclosed IPV did so at their first visit compared with women, especially with respect to sexual IPV: 6 men (50.0%) compared with 42 women (79.2%). During follow-up, 16 participants (6.7% of 238 who returned to the clinic at least once), including 8 men, 7 women, and 1 gender-diverse participant, disclosed experiencing IPV during their recovery period. Disclosing IPV at any visit was associated with a 45% lower likelihood of returning to a pre-injury level of function with respect to work (hazard ratio [HR], 0.55 [95% confidence interval (CI), 0.33 to 0.91]; p = 0.021) and a 36% lower likelihood of returning to a pre-injury overall level of functioning (HR, 0.64 [95% CI, 0.46 to 0.90]; p = 0.01). Conclusions: Results showed an unacceptably high prevalence of IPV in all genders. Gender differences in timing of disclosure emphasize the need for tailored approaches in clinical settings and repeated opportunities for IPV disclosure. This study emphasizes the hidden nature of IPV among patients with orthopaedic trauma and its effects on their health and recovery. Level of Evidence: Prognostic Level II . See Instructions for Authors for a complete description of levels of evidence.

Purpose Despite optimal surgical intervention, patients with femoral shaft fractures often report functional limitations, pain, and an overall reduction in their quality of life. The clinical objective of the FLiP pilot trial was to determine whether patient positioning during femur fixation influences postoperative femoral alignment and associated health outcomes. This secondary analysis aimed to identify demographic and surgical factors associated with health-related quality of life and functional outcomes in FLiP trial participants using data from the EuroQol-5 Dimensions 5-Level (EQ-5D-5L) visual analog scale (VAS), EQ-5D-5L Function, and modified Harris Hip Score (mHHS). Methods We conducted three linear repeated measure mixed models to determine factors associated with the EuroQol-5 Dimensions (EQ-5D-5L) visual analog scale (VAS), EQ-5D-5L Function, and modified Harris Hip Score (mHHS) over 6-week, 3-month, and 6-month postoperative fixation. Results were presented as adjusted mean differences (AMDs), 95% confidence intervals (CIs), and p-values. Results A total of 96 participants were included in this secondary analysis. The mean age was 61.8 years (SD 26.1), and 51 (53.1%) participants were female. Most participants had a proximal third diaphysis fracture (65.3%), followed by a mid-diaphyseal fracture (33.7%), and a distal third diaphysis fracture (1.0%), with subtrochanteric fractures present in 59 (61.5%) participants. A higher Injury Severity Score (ISS) was associated with a lower EQ-5D-5L VAS score (AMD −0.78, 95% CI −1.44 to −0.11; p = 0.04), indicating a worse health status. Open fractures (n = 3) were associated with lower EQ-5D-5L Function scores compared to closed fractures (AMD −0.26, 95% CI −0.45 to −0.067; p = 0.01), indicating worse function. No factors were found to be significantly associated with mHHS. Conclusions These results highlight the importance of injury severity within the context of patient health-related quality of life and demonstrate that regardless of the quality of fracture fixation, participants may experience a slower recovery due to sustaining multiple injuries. These findings offer valuable prognostic information for surgeons to share with patients who have more severe injuries. Trial Registration ClinicalTrials.gov NCT0386280.

Background: The role of research personnel (e.g., research assistants, research coordinators, research managers, etc.) is critical to the success of clinical trials in orthopaedic surgery. Retention of research personnel is a challenge faced by many academic surgical researchers. Limited investigation has been conducted to identify and quantify factors that lead to low retention rates, especially in the field of orthopaedic surgery clinical research. Methods: We developed an electronic survey, containing the validated Job Satisfaction Survey (JSS), to evaluate job satisfaction, career path, and educational pathways in the context of long-term retention of research personnel working in orthopaedic surgery. We distributed the anonymized survey to research personnel who currently or had previously participated in at least 1 orthopaedic trauma clinical trial coordinated by a university-affiliated surgical methods center. Results: Seventy-two research personnel working on clinical orthopaedic studies completed the survey (43%). Using the JSS, overall respondent scores (mean 143.8, SD 26.6) fell on the border of the ambivalent and satisfaction categories. The lowest mean scores, representing dissatisfaction (scores <12), were seen within the promotion (11.4, SD 4.9) and pay (11.9, SD 5.1) subscales. Higher pay was the most common factor that would increase respondents’ satisfaction in their current position (72%). Almost half (46%) expressed funding being a barrier to accessing continuing education, and 54% were unsure or considered clinical research in orthopaedic trauma a temporary position. Four main themes arose from the qualitative portion of the survey: (1) appreciation and involvement, (2) institutional barriers, (3) training, and (4) support from the principal investigator. Conclusions: Research personnel in clinical orthopaedic trauma surgery are a highly motivated group with job satisfaction bordering ambivalence into satisfaction. Despite the desire to grow in their positions, pay and inadequate funding to support continuing education opportunities are barriers. The qualitative findings provide additional insights into how job satisfaction and retention can be improved among clinical research personnel in orthopaedic trauma surgery. Level of Evidence: Level III . See Instructions for Authors for a complete description of levels of evidence.

Objectives: This study examined the benefits of a dedicated social worker in the fracture clinic setting as perceived by patients and caregivers. Methods: This cross-sectional survey engaged patients aged 18 and older presenting to the fracture clinic associated with a level 1 trauma center. Surveys were available in English and Arabic and included 11 questions designed to measure level of agreement with various aspects of social worker presence in the outpatient fracture clinic. Results: A total of 199 patients and caregivers participated in this study. Most of the participants were female (61.8%) and older than the age of 50 (57.1%). While there was nuance in the circumstances and issues participants felt were appropriate for social worker assistance, most (95.4%) found the general premise of having a dedicated social worker available in the fracture clinic to be acceptable and believed that it would be beneficial to fracture clinic patients. Participants indicated that social workers could support trauma patients with multiple issues (≥60% level of agreement across all items). Conclusions: Orthopaedic trauma patients and their caregivers overwhelmingly support the addition of a dedicated social worker to the fracture clinic, with a high level of agreement across demographic groups and proposed social worker interventions. The patient and caregiver population finds the fracture clinic to be an appropriate and viable setting for the mitigation of nonphysical impacts of orthopaedic trauma. These findings can inform the development of potential future additions of social services to the fracture clinic. Level of Evidence: Level IV.

Objectives: Patient engagement in the design and implementation of clinical trials is necessary to ensure that the research is relevant and responsive to patients. The PREP-IT trials, which include 2 pragmatic trials that evaluate different surgical preparation solutions in orthopaedic trauma patients, followed the patient-centered outcomes research (PCOR) methodology throughout the design, implementation, and conduct. We conducted a substudy within the PREP-IT trials to explore participants' experiences with trial participation. Methods: At the final follow-up visit (12 months after their fracture), patients participating in the PREP-IT trials were invited to participate in the substudy. After providing informed consent, participants completed a questionnaire that asked about their experience and satisfaction with participating in the PREP-IT trials. Descriptive statistics are used to report the findings. Results: Four hundred two participants participated in the substudy. Most participants (394 [98%]) reported a positive experience, and 376 (94%) participants felt their contributions were appreciated. The primary reasons for participation were helping future patients with fracture (279 [69%]) and to contribute to science (223 [56%]). Two hundred seventeen (46%) participants indicated that their decision to participate was influenced by the minimal time commitment. Conclusions: Most participants reported a positive experience with participating in the PREP-IT trials. Altruism was the largest motivator for participating in this research. Approximately half of the participants indicated that the pragmatic, low-participant burden design of the trial influenced their decision to participate. Meaningful patient engagement, a pragmatic, and low-burden protocol led to high levels of participant satisfaction.