Pragmatic 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.Given 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.7 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).Implementing 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.
Objective: To evaluate the association between patient- and center-level characteristics and discharge to an inpatient facility versus home after treatment for lower extremity trauma, as well as examine the variability in discharge disposition across clinical centers after controlling for these factors. Design: This is an analysis of data collected prospectively across 5 multicenter studies of extremity trauma. Setting: US Trauma Centers. Participants: Patients 18–80 years with lower extremity trauma treated at 1 of 55 participating centers. Main Outcome Measure: Discharge disposition. Results: Among 2365 patients treated at 1 of 55 centers across 13 states, 673 (28.5%) were discharged to an inpatient facility, and 1692 (71.5%) were discharged home. Individuals who were older, female, unmarried, insured, higher body mass index, history of severe alcohol abuse, Gustilo type IIIB or IIIC open injuries, bilateral, spine and upper extremity injuries, higher injury severity score scores, or intensive care unit stay were more likely to be discharged to an inpatient facility. Even after accounting for patient- and center-level characteristics, there was substantial variation in discharge disposition across centers (likelihood ratio test: P < 0.001). Conclusion: Variation in discharge disposition may represent a potential for improvement in resource utilization and cost savings. Further studies are needed to examine the relationship between utilization of postdischarge inpatient facility after trauma and outcomes. Level of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
This study presents a first clinical translation of bone viability classification technology based on fluorescence imaging and subsequent image texture analysis to provide orthopedic surgeons with intraoperative information for patient treatment optimization.
To evaluate physical function and return to independence of geriatric trauma patients, to compare physical function outcomes of geriatric patients who sustained high-energy trauma with that of those who sustained low-energy trauma, and to identify predictors of physical function outcomes.Retrospective.Urban Level I trauma center.Study group of 216 patients with high-energy trauma and comparison group of 117 patients with low-energy trauma.Injury mechanism (high- vs. low-energy mechanism).Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF) patient-reported outcome measure, and change in living situation and mobility.Physical function outcomes and return to independence differed between patients with high-energy and low-energy injuries. High-energy geriatric trauma patients had significantly higher PROMIS PF scores compared with low-energy geriatric trauma patients (PROMIS PF score 42.2 ± 10.4 vs. 24.6 ± 10.4, P < 0.001). High-energy geriatric trauma patients were able to ambulate outdoors without an assistive device in 67% of cases and were living independently 74% of the time in comparison with 28% and 45% of low-energy geriatric trauma patients, respectively (P < 0.001, P < 0.001). Multivariate linear regression analysis demonstrated that low-energy mechanism injury was independently associated with a 13.2 point reduction in PROMIS PF score (P < 0.001).Geriatric patients greater than 1 year out from sustaining a high-energy traumatic injury seem to be functioning within the expected range for their age, whereas low-energy trauma patients seem to be functioning substantially worse than both age-adjusted norms and their high-energy cohorts.Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
Abstract Background Extremity fractures are common, and most are managed operatively; however, despite successful reduction, up to half of patients report persistent post-surgical pain. Furthermore, psychological factors such as stress, distress, anxiety, depression, catastrophizing, and fear-avoidance behaviors have been associated with the development of chronic pain. The purpose of this pilot study was to examine the feasibility of a randomized controlled trial to determine the effect of in-person cognitive behavioral therapy (CBT) vs. usual care on persistent post-surgical pain among patients with a surgically managed extremity fracture. Methods Eligible patients were randomized to either in-person CBT or usual care. We used four criteria to judge the composite measure of feasibility: 1) successful implementation of CBT at each clinical site, 2) 40 patients recruited within 6 months, 3) treatment compliance in a minimum 36 of 40 participants (90%), and 4) 32 of 40 participants (80%) achieving follow-up at one year. The primary clinical outcome was persistent post-surgical pain at one year after surgery. Results Only two of the four participating sites were able to implement the CBT regimen due to difficulties with identifying certified therapists who had the capacity to accommodate additional patients into their schedule within the required timeframe (i.e., 8 weeks of their fracture). Given the challenges associated with CBT implementation, only one site was able to actively recruit patients. This site screened 86 patients and enrolled 3 patients (3.5%) over a period of three months. Participants were unable to comply with the in-person CBT, with no participants attending an in-person CBT session. Follow-up at one year could not be assessed as the pilot study was stopped early, three months into the study, due to failure to achieve the other three feasibility criteria. Conclusion Our pilot trial failed to demonstrate the feasibility of a trial of in-person CBT versus usual care to prevent persistent pain after surgical repair of traumatic long-bone fractures and re-enforces the importance of establishing feasibility before embarking on definitive trials. Protocol modifications to address the identified barriers include the delivery of our intervention as a therapist-guided, remote CBT program. Trial registration ClinicalTrials.gov (Identifier NCT03196258); Registered June 22, 2017, https://clinicaltrials.gov/ct2/show/NCT03196258
Dynamic contrast-enhanced fluorescence imaging (DCE-FI) classification of tissue viability in twelve adult patients undergoing below knee leg amputation is presented. During amputation and with the distal bone exposed, indocyanine green contrast-enhanced images were acquired sequentially during baseline, following transverse osteotomy and following periosteal stripping, offering a uniquely well-controlled fluorescence dataset. An unsupervised classification machine leveraging 21 different spatiotemporal features was trained and evaluated by cross-validation in 3.5 million regions-of-interest obtained from 9 patients, demonstrating accurate stratification into normal, suspicious, and compromised regions. The machine learning (ML) approach also outperformed the standard method of using fluorescence intensity only to evaluate tissue perfusion by a two-fold increase in accuracy. The generalizability of the machine was evaluated in image series acquired in an additional three patients, confirming the stability of the model and ability to sort future patient image-sets into viability categories.
We sought to evaluate whether tourniquet use, with the resultant ischemia and reperfusion, during surgical treatment of an open lower-extremity fracture was associated with an increased risk of complications.This is a retrospective cohort study of 1,351 patients who had an open lower-extremity fracture at or distal to the proximal aspect of the tibia and who participated in the FLOW (Fluid Lavage of Open Wounds) trial. The independent variable was intraoperative tourniquet use, and the primary outcome measures were adjudicated unplanned reoperation within 1 year of the injury and adjudicated nonoperative wound complications.Unplanned reoperation and nonoperative wound complications were roughly even between the no-tourniquet (18.7% and 19.1%, respectively) and tourniquet groups (17.8% and 20.8%) (p = 0.78 and p = 0.52). Following matching, as determined by model interactions, tourniquet use was a significant predictor of unplanned reoperation in Gustilo Type-IIIA (odds ratio, 3.60; 95% confidence interval, 1.16 to 11.78) and IIIB fractures (odds ratio, 16.61; 95% confidence interval, 2.15 to 355.40).The present study showed that tourniquet use did not influence the likelihood of complications following surgical treatment of an open lower-extremity fracture. However, in cases of severe open fractures, tourniquet use was associated with increased odds of unplanned reoperation; surgeons should be cautious with regard to tourniquet use in this setting.Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
Following orthopaedic trauma, bone devitalization is a critical determinant of complications such as infection or nonunion. Intraoperative assessment of bone perfusion has thus far been limited. Furthermore, treatment failure for infected fractures is unreasonably high, owing to the propensity of biofilm to form and become entrenched in poorly vascularized bone. Fluorescence-guided surgery and molecularly-guided surgery could be used to evaluate the viability of bone and soft tissue and detect the presence of planktonic and biofilm-forming bacteria. This proceedings paper discusses the motivation behind developing this technology and our most recent preclinical and clinical results.
Commentary Since The Boston Globe published its Spotlight Team investigational series targeting overlapping and/or concurrent surgeries in 20151, a great deal of attention has been placed on this practice. Many academic institutions have responded by creating or revising existing policies around overlapping surgical procedures as well as by including and disclosing these policies in the consent process. These changes have occurred in the context of limited evidence around such policies. The present study contributes to the mounting literature suggesting that overlapping surgery is at least noninferior to nonoverlapping surgery with regard to postoperative complications, reoperation, readmission, morbidity, and mortality. The authors performed a matched retrospective study of 18,316 patients who had electively scheduled orthopaedic procedures at their single institution, 3,395 (18.5%) of whom underwent overlapping surgeries. They analyzed all overlapping procedures together as well as divided into “beginning overlap only” and “end overlap only.” The authors found that any form of overlap (beginning, end, or both) appears safe and was noninferior with regard to all outcomes of interest (complications, unplanned reoperation, readmission, mortality, or emergency-room visits). In an era in which patient needs are growing in the setting of increasing health-care constraints, both in terms of physical resources (i.e., hospital beds and operating rooms) as well as personnel (i.e., surgeons, anesthesiologists, certified registered nurse anesthetists, and operating-room nurses), it is financially critical and ethical that the system become more efficient. Overlapping surgeries are frequently part of this effort to optimize efficiency and ensure timely patient care in a resource-constrained environment. It is common sense that the safety of overlapping procedures depends both on the complexity of the procedure in question as well as on the appropriate delegation of tasks to match the skills of those assisting in the operating room. The results of this study suggest that surgeons have a good understanding of the skills and limits of those assisting, whether they are residents, fellows, or physician assistants, in the context of the case complexity. The real question is how to identify and/or manage surgeons who are overextending or taking on more procedures than they truly have the capacity for, at the cost of patient care. This is relevant to overlapping procedures as well as to other sorts of clinical decision-making and case selection. This is only a small part of the broader questions around how we, as an orthopaedic community, are going to monitor ourselves. Institutional policies around types of procedures that are inappropriate for overlap are sensible, and intrainstitutional or community-based peer-review processes are necessary to ensure that surgeons and hospitals are practicing in the patients’ best interest. It is vital that we continue to study these processes to ensure that we are improving safety and improving health-care efficiency and that we are basing policies on established evidence and on the preferences of our patients rather than in response to a journalistic exposé.
