Paula McKay

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.

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.

In response to the COVID-19 pandemic, clinical research groups across the world developed trial protocols to evaluate the safety and efficacy of treatments for COVID-19. Despite this initial enthusiasm, only a small portion of these protocols were implemented. Of those implemented, a fraction successfully recruited their target sample size to analyze and disseminate findings. More than a year and a half into the COVID-19 pandemic, only a few clinical trials evaluating treatments for COVID-19 have generated new evidence. Productive randomized platform clinical trials evaluating COVID-19 treatments may attribute their success to intentional investments in developing resilient clinical trial infrastructures. Health system resiliency discourse provides a conceptual framework for characterizing attributes for withstanding shocks. This framework may also be useful for contextualizing the attributes of productive clinical trials evaluating COVID-19 therapies. We characterize the successful attributes and lessons learned in developing the TOGETHER Trial infrastructure using a health system resiliency framework. This framework may be considered by clinical trialists aiming to build resilient trial infrastructures capable of responding rapidly and efficiently to global health threats.

Background: The prevalence of gender-based and sexual harassment in the field of orthopaedic surgery in Canada is high. Previous research in other jurisdictions has identified the most common perpetrators of harassment to be senior surgeons or directors. We aimed to identify the most frequent perpetrators of gender-based and sexual harassment in orthopaedic surgery in Canada. Methods: We conducted a Canada-wide survey of all orthopaedic surgeons registered with the Canadian Orthopaedic Association and the Canadian Orthopaedic Residents’ Association. The development of our 116-item questionnaire was informed by a review of the literature and other published gender-based and sexual harassment surveys. Descriptive analyses, including frequency counts with associated 95% confidence intervals (CIs), are reported for all data. Results: Of the 465 survey respondents, the median age was 43 years (interquartile range, 35 to 59) and respondents were most commonly male (72%), White (81%), married (77%), and staff orthopaedic surgeons (68%). Peers were identified as the most common perpetrators of gender-based harassment (55%, 95% CI, 50 to 59), and patients were identified as the most common perpetrators of sexual harassment (48%, 95% CI, 43 to 52). Women were more likely to report direct supervisors or patients as the perpetrators of gender-based and sexual harassment, and men reported peers as the most common perpetrators. Conclusion: Orthopaedic surgery peers and patients are the most commonly reported perpetrators of gender-based and sexual harassment in Canada. The results of this study may be helpful to institutions in designing and focusing educational programs and/or policies and procedures to help reduce harassment incidents in the training and work environment.

The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data. The FLOW pilot study and definitive trial were factorial trials evaluating the effect of different irrigation solutions and pressures on re-operation. To explore treatment effects over time, we analyzed data from the pilot and definitive trial in increments of 250 patients until the final sample size of 2447 patients was reached. At each increment we calculated the relative risk (RR) and associated 95% confidence interval (CI) for the treatment effect, and compared the results that would have been reported at the smaller enrolments with those seen in the final, adequately powered study. The pilot study analysis of 89 patients and initial incremental enrolments in the FLOW definitive trial favored low pressure compared to high pressure (RR: 1.50, 95% CI: 0.75–3.04; RR: 1.39, 95% CI: 0.60–3.23, respectively), which is in contradiction to the final enrolment, which found no difference between high and low pressure (RR: 1.04, 95% CI: 0.81–1.33). In the soap versus saline comparison, the FLOW pilot study suggested that re-operation rate was similar in both the soap and saline groups (RR: 0.98, 95% CI: 0.50–1.92), whereas the FLOW definitive trial found that the re-operation rate was higher in the soap treatment arm (RR: 1.28, 95% CI: 1.04–1.57). Our findings suggest that studies with smaller sample sizes would have led to erroneous conclusions in the management of open fracture wounds. NCT01069315 (FLOW Pilot Study) Date of Registration: February 17, 2010, NCT00788398 (FLOW Definitive Trial) Date of Registration: November 10, 2008.