Optimizing the implementation of a multisite feasibility trial of a mind-body program in acute orthopedic trauma.

The Toolkit for Optimal Recovery (TOR) is a mind-body program for patients with acute orthopedic injuries who are at risk for persistent pain/disability. In preparation for a multisite feasibility trial of TOR at three orthopedic trauma centers, we aim to qualitatively identify barriers and facilitators to study implementation and strategies to mitigate the implementation barriers and leverage facilitators.We conducted 18 live video focus groups among providers and three one-on-one interviews with department chiefs at Level 1 trauma centers in three geographically diverse sites (N = 79 participants). Using a content analysis approach, we detected the site-specific barriers and facilitators of implementation of TOR clinical trial. We organized the data according to 26 constructs of the Consolidated Framework for Implementation Research (CFIR), mapped to three Proctor implementation outcomes relevant to the desired study outcomes (acceptability, appropriateness, and feasibility). Across the three sites, we mapped six of the CFIR constructs to acceptability, eight to appropriateness, and three to feasibility. Prominent perceived barriers across all three sites were related to providers' lack of knowledge/comfort addressing psychosocial factors, and organizational cultures of prioritizing workflow efficiency over patients' psychosocial needs (acceptability), poor fit between TOR clinical trial and the fast-paced clinic structure as well as basic needs of some patients (appropriateness), and limited resources (feasibility). Suggestions to maximize the implementation of the TOR trial included provision of knowledge/tools to improve providers' confidence, streamlining study recruitment procedures, creating a learning collaborative, tailoring the study protocol based on local needs assessments, exercising flexibility in conducting research, dedicating research staff, and identifying/promoting champions and using novel incentive structures with regular check-ins, while keeping study procedures as nonobtrusive and language as de-stigmatizing as possible. These data could serve as a blueprint for implementation of clinical research and innovations in orthopedic and other medical settings.

Return to Sport After Medial Patellofemoral Ligament Reconstruction: A Systematic Review and Meta-analysis.

BACKGROUND: Patellar instability is frequently encountered in the athletic population. Medial patellofemoral ligament (MPFL) reconstruction is a common strategy to treat recurrent patellar dislocation and demonstrates good clinical outcomes. PURPOSE/HYPOTHESIS: The purpose was to examine return to sport after MPFL reconstruction for patellar instability. We hypothesized that patients would resume athletic activity at a high rate and that a large proportion would return to their preoperative level of performance. STUDY DESIGN: Systematic review and meta-analysis. METHODS: A systematic review of the literature was conducted using PubMed and Cochrane Library databases to identify articles reporting return to sport after MPFL reconstruction for recurrent patellar dislocation. Athletes were defined as those reporting a preoperative sport. A random-effects model was used to evaluate return to sport rates, subsequent level, and rate of instability recurrence. Meta-regression was used to compare return to sport rates in patients undergoing MPFL reconstruction without osteotomy compared with those treated with simultaneous tibial tubercle osteotomy or trochleoplasty. RESULTS: In total, 23 articles met inclusion criteria after full-text review. A total of 930 patients were analyzed, including 786 athletes. Women represented 61.3% of all patients. The overall mean age was 21.1 years (range, 9.5-60.0 years), with a mean follow-up time of 3.0 years (range, 0.8-8.5 years). The return to sport rate was 92.8% (95% CI, 86.4-97.6). Patients returned to or surpassed their preoperative level of activity in 71.3% (95% CI, 63.7-78.4) of cases. An osteotomy was performed on 10.5% of athletes. Return to sport did not differ significantly in patients undergoing MPFL reconstruction without osteotomy versus those receiving additional osteotomy (95.4% vs 86.9%; P = .22). Patients returned to sport at a mean of 6.7 months (range, 3.0-6.4 months) postoperatively. Osteotomy did not affect return time. Complications occurred at an overall rate of 8.8%. The most common complication was recurrence of instability (1.9%; 95% CI, 0.4-4.0). The Kujala score was reported by 13 studies, with pre- and postoperative combined means of 60.3 and 90.0, respectively. CONCLUSION: MPFL reconstruction is an effective and reliable treatment in the setting of patellofemoral instability. Surgeons can counsel their patients that they can expect a high rate of return to sport after MPFL reconstruction surgery alone or with concomitant osteotomy.

Patient-reported outcome scores following patellar instability surgery-high prevalence does not equal high responsiveness: a systematic review.

PURPOSE: The purpose of this study was to determine the utilization and responsiveness of common patient-reported outcomes (PROs) in patients undergoing surgery for patellar instability. METHODS: Using PRISMA guidelines, a systematic review of studies reporting outcomes following surgical intervention for patellar instability was conducted using Pubmed, Cochrane, OVID Medline, and Google Scholar. Subgroup analysis of articles reporting at least two PROs with baseline and follow-up data were used to evaluate responsiveness of instruments using relative efficiency and effect size. RESULTS: From the search, 2,848 unique articles were found, of which 178 were included in final analysis (7,122 patients, mean age 22.6, 63.6% female). The most commonly used PRO was the Kujala score (79.2%), followed by the Lysholm (34.8%), and Tegner (30.9%). Seventy-nine articles were eligible for subgroup analysis. The Kujala had a higher relative efficiency than ten of the 14 instruments to which it was compared but had lower relative efficiency compared to the IKDC and Lysholm scores. The Banff Patella Instability Instrument (BPII) and the Norwich score, condition-specific tools, were unable to be fully assessed due to rarity of use and lack of comparisons. CONCLUSION: The hypothesis that the Kujala score is the most commonly used PRO for patellar instability, although other instruments offer greater efficiency was supported by our results. The IKDC and Lysholm scores had similar effect sizes but higher relative efficiencies than the Kujala, thus suggesting better responsiveness. This analysis adds useful information for surgeons on the effectiveness of the most common PRO's for evaluating patellofemoral instability outcomes. LEVEL OF EVIDENCE: Level III.

A Live Video Program to Prevent Chronic Pain and Disability in At-Risk Adults With Acute Orthopedic Injuries (Toolkit for Optimal Recovery): Protocol for a Multisite Feasibility Study.

BACKGROUND: Despite the pivotal role of psychosocial factors in pain and disability after orthopedic injury, there are no evidence-based preventive interventions targeting psychosocial factors in patients with acute orthopedic injuries. We developed the first mind-body intervention focused on optimizing recovery and improving pain and disability in patients with acute orthopedic injuries who exhibit high levels of catastrophic thinking about pain and/or pain anxiety (Toolkit for Optimal Recovery [TOR] after orthopedic injury). In a pilot single-site randomized controlled trial (RCT), the TOR met a priori set benchmarks for feasibility, acceptability, and satisfaction. The next step in developing TOR is to conduct a multisite feasibility RCT to set the stage for a scientifically rigorous hybrid efficacy-effectiveness trial. OBJECTIVE: The objective of this study is to conduct a rigorous multisite feasibility RCT of TOR to determine whether the intervention and study methodology meet a priori set benchmarks necessary for the successful implementation of a future multisite hybrid efficacy-effectiveness trial. In this paper, we describe the study design, manualized treatments, and specific strategies used to conduct this multisite feasibility RCT investigation. METHODS: This study will be conducted at 3 geographically diverse level 1 trauma centers, anonymized as sites A, B, and C. We will conduct a multisite feasibility RCT of TOR versus the minimally enhanced usual care (MEUC) control (60 patients per site; 30 per arm) targeting a priori set feasibility benchmarks. Adult patients with acute orthopedic injuries who endorse high pain catastrophizing or pain anxiety will be recruited approximately 1-2 months after injury or surgery (baseline). Participants randomized to the TOR will receive a 4-session mind-body treatment delivered via a secure live video by trained clinical psychologists. Participants randomized to the MEUC will receive an educational booklet. Primary outcomes include feasibility of recruitment, appropriateness, feasibility of data collection, acceptability of TOR (adherence to sessions), and treatment satisfaction across all sites. We will also collect data on secondary implementation outcomes, as well as pain severity, physical and emotional function, coping skills, and adverse events. Outcomes will be assessed at baseline, posttreatment, and at the 3-month follow-up. RESULTS: Enrollment for the RCT is estimated to begin in June 2021. The target date of completion of the feasibility RCT is April 2024. The institutional review board approval has been obtained (January 2020). CONCLUSIONS: This investigation examines the multisite feasibility of TOR administered via live videoconferencing in adult patients with acute orthopedic injuries. If feasible, the next step is a multisite, hybrid efficacy-effectiveness trial of TOR versus MEUC. Preventive psychosocial interventions can provide a new way to improve patient and provider satisfaction and decrease suffering and health care costs among patients with orthopedic injuries who are at risk for chronic pain and disability. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/28155.

Pain Medication Administered and Prescribed to Patients With an Ankle Sprain Treated in an Emergency Department: A Record-Based Cohort Study.

INTRODUCTION: Recent data indicate that patients treated in the emergency department for an ankle sprain receive multiple medications. However, research has not been able to accurately identify all the medications because of study limitations. The primary purpose of this study was to document the type of medication, number of doses, and number of encounters given a prescription at discharge or instructions to take over-the-counter medication. The secondary purpose was to determine if the proportion of encounters given each type of medication varied on the basis of age, sex, race, and year. METHODS: A retrospective record-based cohort study design was used to review the electronic medical records (N = 1740) of encounters reporting to a southeast academic level 1 trauma center and diagnosed with an ankle sprain between 2013 and 2017. All relevant data were extracted for nonsteroidal anti-inflammatory drugs, muscle relaxants, opioids, and nonopioid analgesics. RESULTS: Fifty-eight percent of the encounters had at least 1 dose of medication administered in the emergency department. Twenty-eight percent received a prescription at discharge, and 54.5% were instructed to take over-the-counter medication. Cumulatively, opioids accounted for most of the medications, but the yearly rates declined from 2013 to 2017. A greater proportion of patients aged ≤15 years received nonsteroidal anti-inflammatory drugs or nonopioid analgesics. Most of the patients aged >15 years received opioid medication. DISCUSSION: Patients are primarily given an opioid or nonsteroidal anti-inflammatory drug in the emergency department. Fewer patients receive a prescription at discharge but are regularly instructed to take over-the-counter medication.

Physical therapy referral and medication for ankle sprain visits to physician offices: an analysis of the national ambulatory medical care survey.

OBJECTIVES: Supervised physical therapy is the recommended care for an ankle sprain. Yet, recent evidence indicates some ankle sprain patients may not receive the recommended care, and instead, prescribed medication to alleviate symptoms. Therefore, the purpose of this study is to describe the percentage of patients reporting to an office-based physician in the U.S. that were or were not referred to physical therapy. Secondly, to describe the percentage of ankle sprain patients with or without medication administered, supplied or ordered. METHODS: This was a secondary analysis of the cross-sectional National Ambulatory Medical Care Survey (NAMCS) from 2007 to 2016. The NAMCS is a multi-stage probability sample survey of visits to office-based physicians. The percentage and associated 95% confidence intervals (CI) were calculated for visits that had a physical therapy referral or a non-steroidal anti-inflammatory drug (NSAID), opioid and non-opioid analgesics administered, supplied or ordered. Sampled data were weighted to produce national-level estimates. RESULTS: A physical therapy referral was given for 16.8% (95% CI: 13.2, 21.2) of ankle sprain visits. Approximately 34.5% (95%CI: 30.5, 38.7) of all ankle sprain visits had a medication administered, supplied or ordered. NSAIDs (72.1%; 95% CI: 66.9,76.8) and opioids (21.0%; 95% CI: 16.3, 26.5) were the two most common types of medication. CONCLUSIONS: NSAIDs and opioid medication combined were administered, supplied or ordered more frequently than a referral to physical therapy. These findings provide evidence that suggests many ankle sprain patients reporting to an office-based physician are not receiving the recommended care; physical therapy. Rather, medication appears to be the primary type of care provided to patients. These data are important because it gives a focused area to improve the treatment of an ankle sprain by developing strategies that ensure all patients are provided the recommended care from the onset of entering the healthcare system.