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.
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
Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent.The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have.Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation.Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.
To synthesize all-cause complications and reoperations data, and secondary clinical, functional, and radiographic outcomes after the management of very distal ulna fractures (VDUFs) either nonoperatively or operatively.MEDLINE, Embase, and Web of Science were searched for English-language articles from inception to February 17, 2022.Studies reporting the nonoperative or operative management of VDUFs were eligible for inclusion. VDUFs were defined as either being Q2-Q5 distal ulna fractures using the OTA/AO Comprehensive Classification of Fractures for distal ulna fractures associated with distal radius fractures or being amenable to characterization by the classification system for ulnar head, neck and metaphyseal fractures by Biyani et al.Two reviewers independently extracted data from included studies. Study validity was assessed using the methodological index for nonrandomized studies.Seventeen studies (512 VDUFs) were included for analysis. There were 209, 237, and 66 fractures in the nonoperative, open reduction internal fixation (ORIF), and distal ulna resection groups, respectively. Descriptive statistics including weighted mean values, standard deviations, and 95% confidence intervals were calculated.The treatment of VDUFs with nonoperative management, ORIF, or distal ulna resection may all be acceptable treatment options in specific patient populations. Nonoperative management of VDUFs is a promising treatment strategy even for complex fracture patterns in patients 65 years of age or older. Despite higher reoperation rates, ORIF may be considered for the younger, high-demand patient. Distal ulna resection presents with very favorable functional outcomes in patients 65 years of age or older presenting with a complex VDUF with the lowest reoperation rate across all groups.Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
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Purpose In the setting of sacral fractures, percutaneous screw fixation is a reliable, safe, and minimally invasive method for managing most stable and unstable fractures. However, significant variations in sacral anatomy due to sacral dysmorphism (SDM) could prevent safe implementation. This scoping review aimed to highlight such a detrimental yet under-reported variable in managing sacral fractures. Methods A scoping review was conducted following the Arksey and O’Malley framework for scoping studies. A comprehensive literature search of four electronic databases was conducted to identify relevant peer-reviewed studies. Data were extracted from eligible articles to summarize, collate, and create a narrative account of the findings. Results Twenty-one articles were included in our review (18 level III, two level II, and one level I). Studies were categorized into three main groups based on the investigated outcomes: prevalence and determinants of SDM, effect of SDM on the surgical corridor, and efficacy of different intra-operative imaging modalities. The prevalence of SDM ranged from 10 to 85%. The presence of SDM decreased the available surgical corridor at S1, with a compensated increase at S2 and S3. Mixed results regarding accuracy and revision rate were identified between different intra-operative imaging techniques. Conclusion SDM represents consistent yet atypical “safe zone,” sizes, and angles that require careful analysis and technique alterations when placing upper and second sacral segment screws. Considering their limited availability, high cost, and mixed results, navigated imaging systems represent a promising technique that requires more rigorous examination of its efficacy before widespread adoption.