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78 result(s) for "Ghert, Michelle"
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Intrawound vancomycin to prevent infections after spine surgery: a systematic review and meta-analysis
Purpose Post-operative spine surgical site infections are associated with substantial morbidity, mortality, and economic burden. Intrawound vancomycin may prevent infections after spine surgery, but recent studies have reported conflicting results. The objectives of this systematic review and meta-analysis were to determine: (1) In patients undergoing spine surgery, does the application of intrawound vancomycin lead to reduced rates of post-operative surgical site infections? (2) Are there differences in the estimates of effect between observational studies and randomized trials? (3) What adverse events are reported in the literature? Methods All published comparative studies of intrawound vancomycin in spine surgery were included. Two reviewers independently screened eligible articles and assessed study quality. Observational studies and randomized trials were pooled separately using a random-effects model. Results Eight observational studies and one randomized controlled trial met the inclusion criteria. Across observational studies, the odds of infection with intrawound vancomycin was 0.19 times the odds of infection without intrawound vancomycin (95 % CI 0.08–0.47, p  = 0.0003, I 2  = 52 %). The single randomized controlled trial produced a conflicting result (OR 0.96, 95 % CI 0.34–2.66, p  = 0.93). There were no adverse events attributable to intrawound vancomycin. The quality of the evidence was low or very low. Conclusions There is a lack of high-quality evidence to inform the use of intrawound vancomycin in spine surgery. Surgeons should be cautious before widely adopting this intervention and should be vigilant in monitoring for adverse effects. Further investigation with additional randomized controlled trials is justified.
Surgical Management of Bone Metastases: Quality of Evidence and Systematic Review
Background Surgical management of metastatic bone disease (MBD) is typically reserved for lesions with the highest risk of fracture. However, the high risk of perioperative complications associated with surgery may outweigh the benefits of improved pain and/or function. The goal of this study was to (1) assess the quality of current evidence in this domain; (2) confirm that surgical management of metastases to the long bones and pelvis/acetabulum provides pain relief and improved function; and (3) assess perioperative morbidity and mortality rates. Methods We conducted a systematic review of the literature for clinical studies that reported pain relief and function outcomes, as well as perioperative complications and mortality, in patients with MBD to the long bones and/or pelvis/acetabulum treated surgically. Multiple databases were searched up to January 2012. Pooled weighted proportions are reported. Results Forty-five studies were included in the final analysis, with 807 patients. All included studies were level IV with ‘moderate’ overall quality of evidence using the Methodological Index for Non-Randomized Studies scale. Pain relief following surgical management of metastases was 93, 91, and 93 % in the humerus, femur, and pelvis/acetabulum, respectively. Maintained or improved function after surgery was seen in 94, 89, and 94 % in the humerus, femur, and pelvis/acetabulum, respectively. Perioperative complications and mortality were 17 and 4 %, respectively. Conclusions Despite the inherent limitations of the current evidence, a benefit for the surgical management of bone metastases to the long bones and pelvis/acetabulum is evident; however, there is still substantial risk of perioperative morbidity and mortality that should be considered.
A survey to determine the zone of equipoise for the Proximal FEmur Resection or Internal Fixation fOR Metastases (PERFORM) randomized controlled trial
Objective The objective of this study was to establish a zone of clinical equipoise for the Proximal FEmur Resection or Internal Fixation fOR Metastases (PERFORM) randomized controlled trial, which will compare resection and endoprosthetic reconstruction to internal fixation for skeletal metastases of the proximal femur. Methods A survey was developed, piloted, and distributed to self-declared interested stakeholders in the PERFORM trial. The survey targeted orthopedic oncologists and was designed to assess patient and bone lesion characteristics that drive surgical decision-making in the treatment of skeletal metastases in the proximal femur. An Ethics Waiver was obtained at the lead academic institution and data was collected in the REDCap survey database. Results Responses were complete from 76 surgeons across North America, South America, Europe, Asia, and Africa. Response rate from self-declared interested stakeholders was 70%, with additional responses collected from a broader international audience. Responses indicate that a study population for which either resection and endoprosthetic reconstruction or internal fixation are acceptable options include (1) life expectancy at least 6 months, (2) bone loss of no more than 75% and no less than 25%, and (3) minimal to moderate risk for perioperative complications. Ninety-three percent of respondents indicated that they would be interested in participating in the PERFORM trial. Conclusion A preliminary zone of equipoise for the PERFORM trial includes patients with 25–75% bone loss, low to moderate risk of operative complications, and life expectancy of at least 6 months. Further stakeholder discussions have finalized the PERFORM trial protocol prior to study initiation.
Rethinking the Prognostic Role of Necrosis in Soft-Tissue Sarcoma: Multidisciplinary Insights from the Sarcoma Academy
Background: Soft-tissue sarcomas (STSs) represent a heterogeneous group of malignancies with widely varying treatment responses and biological behaviors. While spontaneous necrosis (present at diagnosis) is recognized in established sarcoma grading systems, the prognostic significance of therapy-induced necrosis remains uncertain. Inconsistent definitions, methodological variability, and clinical confounders further complicate the interpretation of necrosis as an independent prognostic marker. Methods: This communication synthesizes findings from an international, multidisciplinary webinar hosted by the Sarcoma Academy, critically assessing the utility of therapy-induced necrosis in STS management. Discussions encompassed surgical, pathological, oncological, and radiological perspectives, emphasizing how necrosis is defined, measured, and contextualized in patient care. Results: Heterogeneity in STS subtypes, varied treatment protocols, and sampling inconsistencies challenge the prognostic value of post-treatment necrosis. While substantial necrosis may sometimes signal effective therapy, it can also reflect the tumor’s aggressive nature. The panel underscored the utility of measuring the percentage of viable tumor cells, rather than necrosis alone, to obtain a more standardized and reproducible measure of therapy response. Emerging approaches—such as radiomics, molecular profiling, immune-based analyses, and real-world evidence (RWE) protocols—offer promising avenues for refining prognostication and guiding personalized therapy in STS. Conclusions: A focus solely on therapy-induced necrosis is insufficient to predict outcomes in STS. Instead, a multidisciplinary framework—combining standardized pathology protocols, quantification of viable tumor cells, advanced imaging, and innovative clinical trial designs—can better capture both treatment effects and underlying tumor biology. Future collaborative studies and hybrid trial methodologies are needed to determine which STS subgroups gain the most from intensified treatments aimed at maximizing necrosis, and how to balance such interventions with surgical considerations, toxicity, and overall patient well-being.
Recruitment patterns in a large international randomized controlled trial of perioperative care in cancer patients
Introduction The Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) randomized controlled trial (RCT) was the first study to prospectively enroll and randomize orthopedic oncology patients in multiple centers internationally. The objective of this study was to describe recruitment patterns, to examine the differences in enrollment across different PARITY sites, and to identify variables associated with differing levels of recruitment. Methods Data from this study was obtained from the PARITY trial Methods Center and records of correspondence between the Methods Center and recruiting sites. We performed descriptive statistics to report the recruitment patterns over time. We compared recruitment, time to set up, and time to enroll the first patient between North American and international sites, private and public healthcare models, and the presence or absence of research personnel. Two-tailed non-paired t tests were performed to test average monthly recruitment rates between groups. Results A total of 602 patients from 36 North American and 12 international sites were recruited from 2013 to 2019. North American sites were able to become fully enrollment-ready at an average of 19.5 months and international sites at an average of 27 months. Once enrolling, international sites were able to enroll 0.59 patients per/month whereas North American sites averaged a monthly recruitment rate of 0.2 patients/month once enrolling. Sites with research personnel reached enrollment-ready status at an average of 19.3 months and sites without research support at an average of 30.3 months. Once enrolling, the recruitment rate was 0.28 patients/month and 0.2 patients per month for sites with and without research support, respectively. Publicly funded sites had a monthly enrollment of 0.4 patients/month whereas privately funded sites had a monthly enrollment rate of 0.17 patients/month. Conclusions As a collaborative group, the PARITY investigators increased the pace of recruitment throughout the trial, likely by increasing the number of active sites. The longer time to start-up at international sites may be due to the complex governing regulations of pharmaceutical trials. Nevertheless, international sites should be considered essential as they recruited significantly more patients per month once active. The absence of research support personnel may lead to delays in the time to start-up. The results of the current study will provide guidance for choosing which sites to recruit for participation in future collaborative clinical trials in orthopedic oncology and other surgical specialties. Trial registration ClinicalTrials.gov NCT01479283 . Prospectively registered on November 24, 2011
What happens to intimate partner violence studies registered on clinicaltrials.gov? A systematic review of a clinical trials registry
Background There is an increasing number of interventions aimed at reducing the incidence and improving the identification and management of intimate partner violence (IPV), which are being tested in randomized clinical trials. Publication bias, improper reporting, and selective reporting in clinical trials have led to widespread adoption of pre-registration of clinical trials. Non-publication of study results leads to inefficiency, ethical issues, and scientific issues with the IPV literature. When study results and methodology are not made available through publication or other public means, the results cannot be used to their full potential. The objective of this study was to determine the publication rates of IPV trials registered in a large clinical trial registry. Methods We conducted a systematic review of all IPV-related clinicaltrials.gov records and determined whether the studies that had been completed for ≥ 18 months have been published in a peer-reviewed journal or in the clinicaltrials.gov registry. Two authors extensively searched the literature and contacted study investigators to locate full-text publications for each included study. Results Of 83 completed IPV-related trials registered on clinicaltrials.gov, 64 (77.1%, 95% CI: 66.6–85.6) were subsequently published in full-text form. Of the 19 unpublished studies, authors confirmed that there was no publication for 11 studies; we were unable to contact the investigator or locate a publication for the remaining eight studies. Only four studies (all published) posted their results on clinicaltrials.gov upon completion. Conclusion Approximately one in four IPV trials are not published 18 months after completion, indicating that clinicians, researchers, and other evidence users should consider whether publication bias might affect their interpretation of the IPV literature. Further research is warranted to understand reasons for non-publication of IPV research and methods to improve publication rates.
Orthopaedic Trainees Retain Knowledge After a Partner Abuse Course: An Education Study
Introduction Intimate partner violence (IPV) is a serious global issue that results in a large number of injuries and deaths among women. Educating clinicians about IPV can help providers identify, prevent, and treat victims, and, ultimately, improve care for victims of abuse. We sought to determine the effect of a half-day educational course on IPV for orthopaedic surgical trainees on knowledge and attitudes. Questions/purposes We asked (1) whether a half-day educational course on IPV can improve orthopaedic surgical trainees’ knowledge and (2) attitudes regarding IPV; and (3) whether a course on IPV can be accepted and viewed as valuable by trainees? Methods Using published research on IPV in patients with musculoskeletal injuries, we developed a half-day educational course. The curriculum included lectures and discussion regarding the basics of IPV, the current state of IPV research, what to do when a patient is a victim or perpetrator, and the orthopaedic surgeon’s role in recognizing, preventing, and assisting with IPV. All 33 course participants (30 men and three women), all orthopaedic surgical trainees, completed a questionnaire that included general true or false or agree or disagree statements regarding their knowledge, attitudes, and practices of IPV in the musculoskeletal setting; the questionnaire also included a knowledge test of 25 true or false statements. The questionnaire was administered immediately before, immediately after, and 3 months after the course; 76% (25 of 33) took the test immediately after the course and 82% (27 of 33) completed the test at 3 months. Participant knowledge scores were compared across the three different times to determine the effect of the course. Results Participants increased their knowledge after the course, and the increased knowledge was retained at retesting at 3 months; the mean percentage of correct answers before the course was 57%, which increased to 73% after the course, and was 68% 3 months later (F = 9.505; p = 0.001). Before the course, most of the course participants (30 of 32; 94%) agreed that IPV is an important issue; agreement increased to 100% immediately after the course. The largest change in attitude was in response to the statement: “I am skeptical that the health care system has the resources to screen for IPV.” Before the course, 53% (17 of 32) of trainees endorsed this statement, but the percent decreased to 36% (nine of 25) after the course and remained low at 33% (nine of 27), at the 3-month test. Conclusions Our findings show that a short course on IPV in patients with musculoskeletal injuries led to an improvement and retention of knowledge 3 months after the course. Based on our findings, we recommend that IPV education be integrated in training programs for orthopaedic surgeons. Future projects should focus on developing and implementing a sustainable education program that can affect practice for healthcare professionals and trainees in multiple clinical settings.
A Systematic Review and Meta-analysis of Intralesional Versus Wide Resection for Intramedullary Grade I Chondrosarcoma of the Extremities
Background The surgical management of grade I intramedullary chondrosarcoma of bone remains controversial. The purpose of this study was to perform a systematic review and meta-analysis of published data to determine the oncologic outcomes of intralesional versus wide resection for grade I intramedullary chondrosarcoma. Methods Literature searches were performed through Medline, EMBASE, and the Cochrane Database. Cohort studies in which one patient group with grade I chondrosarcoma underwent wide resection and one underwent intralesional curettage were included. Two reviewers independently assessed all eligible papers with the Newcastle-Ottawa Quality Assessment Scale for Cohort Studies. The outcome measures were the pooled odds ratio and 95% confidence intervals for the risk of local recurrence and metastasis calculated through the random-effects method. Results Five eligible studies were identified including a total of 190 patients, 78 of whom underwent intralesional resection and 112 of whom underwent wide resection. Only one pelvic lesion was identified, which underwent wide resection. There were a total of five local recurrences and three metastases. The risk for local recurrence and metastasis did not differ significantly between the two groups, with an odds ratio for intralesional resection of 2.26 (95% confidence interval, 0.41–12.62) and 0.44 (95% confidence interval, 0.04–5.21) respectively. Conclusions Intralesional curettage as an alternative to wide resection for extrapelvic grade I chondrosarcoma of bone does not greatly increase the risk for local recurrence or metastasis. Overall effect estimates, however, should be interpreted with caution as a result of the relatively small number of events.