Paula McKay

A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds

BACKGROUND The management of open fractures requires wound irrigation and débridement to remove contaminants, but the effectiveness of various pressures and solutions for irrigation remains controversial. We investigated the effects of castile soap versus normal saline irrigation delivered by means of high, low, or very low irrigation pressure. METHODS In this study with a 2-by-3 factorial design, conducted at 41 clinical centers, we randomly assigned patients who had an open fracture of an extremity to undergo irrigation with one of three irrigation pressures (high pressure [>20 psi], low pressure [5 to 10 psi], or very low pressure [1 to 2 psi]) and one of two irrigation solutions (castile soap or normal saline). The primary end point was reoperation within 12 months after the index surgery for promotion of wound or bone healing or treatment of a wound infection. RESULTS A total of 2551 patients underwent randomization, of whom 2447 were deemed eligible and included in the final analyses. Reoperation occurred in 109 of 826 patients (13.2%) in the high-pressure group, 103 of 809 (12.7%) in the low-pressure group, and 111 of 812 (13.7%) in the very-low-pressure group. Hazard ratios for the three pairwise comparisons were as follows: for low versus high pressure, 0.92 (95% confidence interval [CI], 0.70 to 1.20; P=0.53), for high versus very low pressure, 1.02 (95% CI, 0.78 to 1.33; P=0.89), and for low versus very low pressure, 0.93 (95% CI, 0.71 to 1.23; P=0.62). Reoperation occurred in 182 of 1229 patients (14.8%) in the soap group and in 141 of 1218 (11.6%) in the saline group (hazard ratio, 1.32, 95% CI, 1.06 to 1.66; P=0.01). CONCLUSIONS The rates of reoperation were similar regardless of irrigation pressure, a finding that indicates that very low pressure is an acceptable, low-cost alternative for the irrigation of open fractures. The reoperation rate was higher in the soap group than in the saline group. (Funded by the Canadian Institutes of Health Research and others; FLOW ClinicalTrials.gov number, NCT00788398.).

Study Design and Hierarchy of Evidence for Surgical Decision Making

This article provides a historical overview of the hierarchy of evidence for surgical decision making and discusses key study designs in the hierarchy of evidence. This encompasses meta-analyses, randomized controlled trials, and observational studies, including cohort and case-controlled studies, case series and case reports, and basic science studies. This article also reviews the principles and importance of evidence-based plastic surgery and describes several systems to rate the strength of the scientific evidence.

Authorship and Ethical Considerations in the Conduct of Observational Studies

Surgeons who participate in research studies frequently struggle with a number of challenges when determining authorship of the publications that arise from their research. Furthermore, new concerns relating to who receives credit and who takes responsibility have emerged with the increase in multicenter research collaborations. This paper provides a discussion of the importance of authorship and outlines a number of ethical issues that commonly arise when determining the author byline. We also present some strategies, such as publishing under group authorship, listing individual author contributions, and revising the mechanism for acknowledging nonauthor contributions, that have the potential to improve authorship and publication practices.

Moving forward through consensus: protocol for a modified Delphi approach to determine the top research priorities in the field of orthopaedic oncology

Introduction Orthopaedic oncology researchers face several obstacles in the design and execution of randomised controlled trials, including finite fiscal resources to support the rising costs of clinical research and insufficient patient volume at individual sites. As a result, high-quality research to guide clinical practice has lagged behind other surgical subspecialties. A focused approach is imperative to design a research programme that is economical, streamlined and addresses clinically relevant endpoints. The primary objective of this study will be to use a consensus-based approach to identify research priorities for international clinical trials in orthopaedic oncology. Methods and analysis We will conduct a 3-phase modified Delphi method consisting of 2 sequential rounds of anonymous web-based questionnaires (phases I and II), and an in-person consensus meeting (phase III). Participants will suggest research questions that they believe are of particular importance to the field (phase I), and individually rate each proposed question on 5 criteria (phase II). Research questions that meet predetermined consensus thresholds will be brought forward to the consensus meeting (phase III) for discussion by an expert panel. Following these discussions, the expert panel will be asked to assign scores for each research question, and research questions meeting predetermined criteria will be brought forward for final ranking. The expert panel will then be asked to rank the top 3 research questions, and these 3 research questions will be distributed to the initial group of participants for validation. Ethics and dissemination An ethics application is currently under review with the Hamilton Integrated Research Ethics Board in Hamilton, Ontario, Canada. The results of this initiative will be disseminated through peer-reviewed publications and conference presentations.

Prophylactic antibiotic regimens in tumour surgery (PARITY): a pilot multicentre randomised controlled trial

Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a five-day regimen of post-operative antibiotics, in comparison to a 24-hour regimen, decreases surgical site infections in patients undergoing endoprosthetic reconstruction for lower extremity primary bone tumours. Methods We performed a pilot international multi-centre RCT. We used central randomisation to conceal treatment allocation and sham antibiotics to blind participants, surgeons, and data collectors. We determined feasibility by measuring patient enrolment, completeness of follow-up, and protocol deviations for the antibiotic regimens. Results We screened 96 patients and enrolled 60 participants (44 men and 16 women) across 21 sites from four countries over 24 months (mean 2.13 participants per site per year, standard deviation 2.14). One participant was lost to follow-up and one withdrew consent. Complete data were obtained for 98% of eligible patients at two weeks, 83% at six months, and 73% at one year (the remainder with partial data or pending queries). In total, 18 participants missed at least one dose of antibiotics or placebo post-operatively, but 93% of all post-operative doses were administered per protocol. Conclusions It is feasible to conduct a definitive multi-centre RCT of post-operative antibiotic regimens in patients with bone sarcomas, but further expansion of our collaborative network will be critical. We have demonstrated an ability to coordinate in multiple countries, enrol participants, maintain protocol adherence, and minimise losses to follow-up. Cite this article: Bone Joint Res;4:154–162

A Scoping Review of Intimate Partner Violence Screening Programs for Health Care Professionals.

Introduction Between 38 and 59 percent of women presenting to health care professionals have experienced intimate partner violence. Consequently, multiple intimate partner violence identification or screening programs within health care settings have been developed; however, substantial variations in program content and interpretation of program effectiveness has resulted in conflicting practice guidelines. The purpose of our scoping review is to broadly identify and synthesize the available literature evaluating intimate partner violence identification programs within health care settings to identify key areas for potential evidence-based recommendations and to focus research priorities in the field. Materials and Methods We conducted a search of MEDLINE, Embase, Cumulative Index of Nursing and Allied Health Literature, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, and psycINFO. We used broad eligibility criteria to identify studies that evaluated intimate partner violence identification programs in health care settings. We completed all screening and data extraction independently and in duplicate. We used descriptive statistics to summarize all data. Results We identified 59 eligible studies evaluating intimate partner violence identification programs within health care settings. The most commonly reported outcome themes were IPV disclosure (69%, n = 35), number of patients screened (39%, n = 20), HCP opinions towards screening (37%, n = 19), and patient opinions towards screening (29%, n = 15). The majority of studies (36 studies (70.6%)) reported positive program evaluation results. Discussion The majority of studies reported positive program evaluation results. This may suggest that many different intimate partner violence identification programs are beneficial for identifying victims of abuse, however, it remains unknown as to whether identification programs prevent future episodes of abuse. Additionally, the substantial heterogeneity of the intervention characteristics, study methodology, and outcome measures assessed limits the ability to make clear recommendations as to the optimal method(s) of screening.

Prescription of Vitamin D to Fracture Patients: A Lack of Consensus and Evidence.

Objectives: We conducted a survey to explore practice patterns regarding the assessment of hypovitaminosis D and the prescription of vitamin D in acute fracture patients. Our secondary objective was to determine whether practice patterns differed between fragility and nonfragility fracture patients. Design: Cross-sectional survey. Setting: All surveys were completed using SurveyMonkey. Patients/Participants: We surveyed surgeon members of the Canadian Orthopaedic Association and the Orthopaedic Trauma Association. Intervention: Survey. Main Outcome Measurements: The proportion of surgeons who routinely prescribe vitamin D to fracture patients. Results: A total of 397 surveys were completed. Of total, 65.8% of surgeons indicated that they routinely prescribe vitamin D to fragility fracture patients and 25.7% routinely prescribe vitamin D to nonfragility fracture patients. We identified considerable variability in dosing regimens, as 45 different dosing regimens were prescribed in fragility fracture patients and 29 in nonfragility fracture patients. They ranged from daily doses of 400 IU to loading doses of 600,000 IU. The most frequently prescribed doses were 1000 IU daily (14.6%), 2000 IU daily (13.4%), and 50,000 IU weekly (8.7%). Respondents indicated that they heavily relied on clinical experience to guide their decisions to prescribe vitamin D to fracture patients. Conclusions: The results of this survey demonstrate multiple areas of uncertainty and a lack of consensus in the prescription of vitamin D to fracture patients. Fragility patients frequently receive vitamin D supplementation, whereas most surgeons do not prescribe vitamin D to young fracture patients. High-quality clinical research is needed to determine whether vitamin D supplementation is beneficial to fracture patients. Level of Evidence: Therapeutic Level V. See Instructions for Authors for a complete description of levels of evidence.

Outcome Measures for Evaluating Intimate Partner Violence Programs Within Clinical Settings A Systematic Review of the Literature

Background: Multiple intimate partner violence (IPV) identification and assistance programs have been implemented across clinical settings. The results of these studies are inconclusive and frequently conflicting, resulting in clinical uncertainty and controversy regarding the merits of IPV identification and assistance programs. We aimed to describe the choice of outcome measures used in previously published randomized trials of IPV identification and assistance programs. Method: A comprehensive literature search was conducted in the Medline, Embase, PyscInfo, and CENTRAL databases. The outcomes assessed in each included study were extracted and categorized, and the methodological quality of each eligible study was assessed using the Cochrane Risk of Bias tool. Results: Of 20 eligible studies, 6 evaluated IPV identification programs and 14 studies examined IPV assistance programs. The included studies used 48 different outcomes that we classified into 10 categories. For identification studies, the most commonly used outcome categories were IPV disclosure (66.7%) and resource use (66.7%). The most commonly used outcome categories for the IPV assistance studies included IPV recurrence and severity (64.3%) and health outcomes (50%). The included studies demonstrated a number of methodological limitations as identified by the Cochrane Risk of Bias instrument. Conclusions: IPV identification and assistance programs are evaluated using many different outcome measures. Although this diversity enriches the IPV literature, it makes it challenging to compare studies. The results of this review highlight the challenges of conducting research in the field of IPV and the complexity of selecting, measuring, and interpreting outcomes.

Moving Forward Through Consensus: A Modified Delphi Approach to Determine the Top Research Priorities in Orthopaedic Oncology

BackgroundSeveral challenges presently impede the conduct of prospective clinical studies in orthopaedic oncology, including limited financial resources to support their associated costs and inadequate patient volume at most single institutions. This study was conducted to prioritize research questions within the field so that the Musculoskeletal Tumor Society (MSTS), and other relevant professional societies, can direct the limited human and fiscal resources available to address the priorities that the stakeholders involved believe will have the most meaningful impact on orthopaedic oncology patient care.Questions/purposesThe purpose of this study was to use a formal consensus-based approach involving clinician-scientists and other stakeholders to identify the top priority research questions for future international prospective clinical studies in orthopaedic oncology.MethodsA three-step modified Delphi process involving multiple stakeholder groups (including orthopaedic oncologists, research personnel, funding agency representation, and patient representation) was conducted. First, we sent an electronic questionnaire to all participants to solicit clinically relevant research questions (61 participants; 54% of the original 114 individuals invited to participate returned the questionnaires). Then, participants rated the candidate research questions using a 5-point Likert scale for five criteria (60 participants; 53% of the original group participated in this portion of the process). Research questions that met a priori consensus thresholds progressed for consideration to an in-person consensus meeting, which was attended by 44 participants (39% of the original group; 12 countries were represented at this meeting). After the consensus panel’s discussion, members individually assigned scores to each question using a 9-point Likert scale. Research questions that met preset criteria advanced to final ranking, and panel members individually ranked their top three priority research questions, resulting in a final overall ranking of research priorities.ResultsA total of 73 candidate research questions advanced to the consensus meeting. In the end, the consensus panel identified four research priorities: (1) Does less intensive surveillance of patients with sarcoma affect survival? (2) What are the survival outcomes over time for orthopaedic oncology implants? (3) Does resection versus stabilization improve oncologic and functional outcomes in oligometastatic bone disease? (4) What is the natural history of untreated fibromatosis?ConclusionsThe results of this study will assist in developing a long-term research strategy for the MSTS and, possibly, the orthopaedic oncology field as a whole. Furthermore, the results of this study can assist researchers in guiding their research efforts and in providing a justified rationale to funding agencies when requesting the resources necessary to support future collaborative research studies that address the identified orthopaedic oncology priorities.

Factors Associated With Health-related Quality of Life in Patients With Open Fractures

Objectives: To analyze FLOW data to identify baseline patient, injury, fracture, and treatment factors associated with lower health-related quality of life (HRQoL) at 12-month postfracture. Design: Prognostic study using data from a prospective randomized controlled trial. Setting: Thirty-one clinical centers in the United States, Canada, Australia, and India. Patients/Participants: One thousand four hundred twenty-seven patients with open fracture from the FLOW trial with complete 12-month Short Form-12 (SF-12) follow-up assessment and no missing data for selected baseline factors. Intervention: Not applicable. Main Outcome Measurement: Physical Component Score (PCS) and the Mental Component Score (MCS) of the SF-12 at 12-month postfracture. Results: One thousand four hundred twenty-seven patients were included in the SF-12 PCS and MCS linear regression models. Smoking, lower preinjury SF-12 PCS and MCS, and work-related injuries were significantly associated with lower SF-12 PCS and MCS at 12-month postfracture. A lower extremity fracture and a wound that was not closed at initial irrigation and debridement were significantly associated with lower 12-month SF-12 PCS but not MCS. Only the adjusted mean difference for lower extremity fractures approached the minimally important difference for the SF-12 PCS. Conclusions: We identified a number of statistically significant baseline factors associated with lower HRQoL; however, only the presence of a lower extremity fracture approached clinical significance. More research is needed to quantify the impact of these factors on patients and to determine whether changes to modifiable factors at baseline will lead to clinically significant improvements in HRQoL after open fractures. Level of Evidence: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.