Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024.

PURPOSE: Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measure- ment INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024. METHODS: The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement. RESULTS: From the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥ 67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final check- list to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review's title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts. CONCLUSION: PRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding expla- nation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA- COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application.

Youth Pitcher Fatigue: Medial Elbow Laxity, Ultrasonographic Assessment of Flexor-Pronator Mass Energy Depletion, and Association With Pitch Count.

Background: Ulnar collateral ligament (UCL) injuries in youth pitchers continue to be concerning despite the institution of pitch count limits. Flexor-pronator mass fatigue can lead to diminished dynamic stability, resulting in greater stress on the UCL. Purpose/Hypothesis: To evaluate fatigue of the flexor-pronator mass by assessing changes in medial elbow laxity; noninvasively characterizing alterations in muscle glycogen; and identifying changes in subjective fatigue, strength, range of motion (ROM), pitching velocity, and accuracy with increasing pitches thrown by youth pitchers to their recommended 75-pitch count limit. It was hypothesized that, with increased pitches, medial elbow laxity would increase and that the glycogen content of the flexor-pronator mass would decrease. Study Design: Descriptive laboratory study. Methods: Healthy male pitchers aged 10 years (n = 22) threw 3 sets of 25 pitches with 12 minutes between sets (3 timepoints). Bilateral ulnohumeral joint gapping was measured by applying a standardized valgus force and utilizing ultrasound imaging. Relative changes in muscle glycogen in the bilateral flexor carpi radialis (FCR), and the flexor digitorum superficialis/flexor carpi ulnaris (FDS/FCU) muscles were measured with ultrasound software and recorded as fuel percentiles. Additional measures obtained included subjective fatigue, strength, ROM, velocity, and accuracy. Results: There were no differences in medial elbow joint-line gapping between the throwing and nonthrowing arms or between timepoints. The throwing arm demonstrated a significant decline in fuel percentile of the FCR from baseline to after 75 pitches (P = .05). There were no differences across timepoints for FDS/FCU fuel percentile values. Fatigue measurements for both arms were significantly higher at all timepoints compared with baseline (P≤ .03). Grip strength of the dominant arm after 75 pitches was decreased significantly compared with after 25 pitches (P = .02). Conclusion: Although an increase in medial elbow joint gapping was not demonstrated within the recommended 75 pitch count limit in 10-year-olds, a relative decrease in glycogen stores of the flexor-pronator mass did occur, as well as a decrease in grip strength, with increasing subjective fatigue. Clinical Relevance: This study provides a foundation for further objective testing of physiologic changes that occur with pitching to better guide pitch count limits and improve the safety of young athletes.

Establishing the Minimally Important Difference for the KOOS-Joint Replacement and PROMIS Global-10 in Patients After Total Knee Arthroplasty.

Background: Despite the overall prevalence and success of total knee arthroplasty (TKA), a significant portion of patients are dissatisfied with their outcomes. Purpose: To assess the responsiveness and determine the minimally important difference (MID) of 2 patient-reported outcome measures (PROMs)-the Knee injury and Osteoarthritis Outcome Score-Joint Replacement (KOOS-JR) and the Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS 10)-in patients after TKA. Study Design: Cohort study (diagnosis); Level of evidence, 3. Methods: Included were patients who underwent TKA from August 2015 through August 2019 and completed baseline and postoperative KOOS-JR and PROMIS 10 surveys. The PROMIS 10 consists of 2 domains: physical health and mental health. Estimates for the reliable change index (RCI) and MID, using anchor-based and distribution-based methods, were calculated for each PROM. Regression modeling was used to determine whether patient and clinical factors predicted MID thresholds or MID achievement. Results: A total of 1315 patients were included. Distribution-based MIDs, calculated using various methods from baseline scores, ranged from 19.3 to 31 for the KOOS-JR, and the RCI was 4.38. Of these patients, 293 (22.3%) demonstrated small or moderate improvement, and this cohort was included in the calculation of anchor-based MIDs. The anchor-based MIDs were 16.9 and 24.3 at 3-month and 1-year follow-up, respectively, and 66% of patients achieved the MID at 12 months. Higher preoperative PROM score, male sex, non-White race, and current smoker status were predictive of failing to achieve the anchor-based MID for KOOS-JR at 1 year postoperatively (P < .05). Higher preoperative PROM score and any 90-day adverse event predicted lower thresholds of important change in anchor-based MIDs. Higher baseline PROM scores, younger age, male sex, non-White ethnicity, higher American Society of Anesthesiologists classification, preoperative narcotics use, not smoking, and longer hospital stay were all associated with lower odds of achieving the MID on the KOOS-JR or either of the PROMIS 10 subscales. Conclusion: The study results demonstrated relevant values for interpretation of the KOOS-JR and PROMIS 10. While patient demographics did not accurately predict which patients would achieve the MID, some potential factors predicting successful patient-reported outcomes after TKA were identified.

CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials.

Randomized controlled trials remain the reference standard for healthcare research on effects of interventions, and the need to report both benefits and harms is essential. The Consolidated Standards of Reporting Trials (the main CONSORT) statement includes one item on reporting harms (i.e., all important harms or unintended effects in each group). In 2004, the CONSORT group developed the CONSORT Harms extension; however, it has not been consistently applied and needs to be updated. Here, we describe CONSORT Harms 2022, which replaces the CONSORT Harms 2004 checklist, and shows how CONSORT Harms 2022 items could be incorporated into the main CONSORT checklist. Thirteen items from the main CONSORT were modified to improve harms reporting. Three new items were added. In this article, we describe CONSORT Harms 2022 and how it was integrated into the main CONSORT checklist and elaborate on each item relevant to complete reporting of harms in randomized controlled trials. Until future work from the CONSORT group produces an updated checklist, authors, journal reviewers, and editors of randomized controlled trials should use the integrated checklist presented in this paper.

Investigating the Association of Patient Body Mass Index With Posterior Subcutaneous Fat Thickness in the Cervical Spine: A Retrospective Radiographic Study.

INTRODUCTION: Although BMI is often used as a surrogate for posterior cervical subcutaneous fat thickness (SFT), the association of BMI with cervical SFT is unknown. We performed a retrospective radiographic study to analyze the relationship between BMI and cervical SFT. METHODS: This was a retrospective cohort study of patients with cervical CT scans. SFT was assessed by measuring the distance (mm) from the spinous processes of C2-C7 to the skin edge. Pearson correlations and linear regression were used to analyze the relationship between BMI and SFT. One-way ANOVA was used to analyze differences in C2-C7 distances while stratifying by BMI. RESULTS: A total of 96 patients were included. BMI had a moderate correlation with average C2-C7 (r=0.546, p < 0.05) SFT, and a weak to moderate correlation with each individual C2-C7 distance. The strongest correlation was at the C7 level (r= 0.583, p < 0.05). These analyses remained significant controlling for potential confounders of patient age, sex, and diabetes. No difference was found in the average C2-C7 distance in patients with BMIs of 25-30 compared to those with BMIs of 30-40 (p=0.996), whereas in patients with BMI <25 and BMI >40, differences were significant (p < 0.05). CONCLUSIONS: BMI is not strongly correlated with SFT in the cervical spine. Although BMI less than 25 or greater than 40 is correlated with respectively decreased or increased cervical SFT, BMI of 25-40 is not correlated with cervical SFT. This is clinically important information for surgeons counseling patients on perioperative risk before undergoing cervical spine procedures, namely infection. Further research delineating the relationship between posterior SFT and surgical site infection in the cervical spine is warranted.

Musculoskeletal Components of Post-Acute Sequelae of SARS-CoV-2 Infections.

➢: Musculoskeletal (MSK) sequelae of severe acute respiratory syndrome coronavirus 2 infections seem to be common. ➢: Mechanisms of such effects are becoming clear. ➢: There is a complex interplay of biopsychosocial effects associated with MSK symptoms after acute coronavirus disease 2019. ➢: Additional research should focus on completely describing the breadth of these MSK sequelae and related psychosocial symptoms.

Patient reported outcomes and ranges of motion after reverse total shoulder arthroplasty with and without subscapularis repair.

Background: In performing reverse total shoulder arthroplasty (rTSA), the role of repairing the subscapularis has been debated. Our objective was to determine the effect of subscapularis repair following rTSA on postoperative shoulder ranges of motion and patient reported outcome scores (PROs). Methods: A prospective registry was reviewed to establish a cohort of primary rTSA patients with a 135-degree humeral implant, with a minimum of 2 years of follow-up. Variables collected included demographics, subscapularis repair information, diagnosis, glenosphere size, and glenoid lateralization information. Outcomes collected were range of motion measurements, subscapularis strength, and multiple generic and shoulder PROs. Multivariable linear regression models were created to predict these 2-year outcomes. Results: The 143-patient cohort had a mean age of 69 years with 68% of patients undergoing subscapularis repair. After adjustment in the multivariable models, whether the subscapularis was repaired did not significantly predict a 2-year forward elevation, external rotation, internal rotation, subscapularis strength, Western Ontario Osteoarthritis of the Shoulder score, VR-12 scores, Constant Score, or American Shoulder and Elbow Surgeons Shoulder Scores. Increased glenoid lateralization significantly predicted greater internal rotation, higher VR-12 physical score, and higher Constant Score. There were no dislocations in either group. Conclusions: After adjusting for patient and implant factors, subscapularis repair was not associated with a 2-year postoperative range of motion, strength, or any PROs suggesting that repairing the subscapularis may not affect functional outcome. Increased glenoid lateralization through the baseplate and glenosphere independently predicted better internal rotation, VR-12 physical score, and Constant Scores indicating a benefit to lateralization during rTSA.

Identifying common core outcome domains from core outcome sets of musculoskeletal conditions: protocol for a systematic review.

BACKGROUND: Core outcome sets (COSs) aim to reduce outcome heterogeneity in clinical practice and research by suggesting a minimum number of agreed-upon outcomes in clinical trials. Most COSs in the musculoskeletal field are developed for specific conditions. We propose that there are likely to be common core domains within existing musculoskeletal COSs that may be used as a starting point in the development of future COSs. We aim to identify common core domains from existing COSs and to facilitate the development of new COSs for musculoskeletal conditions. As a secondary aim, we will assess the development quality of these COSs. METHODS: A systematic review including musculoskeletal COSs. We will search Core Outcome Measures in Effectiveness Trials (COMET) database, MEDLINE, EMBASE, Scopus, Cochrane Methodology Register and International Consortium for Health Outcome Measurement (ICHOM). Studies will be included if related to the development of a COS in adults with musculoskeletal conditions and for any type of intervention. Quality will be assessed using the Core Outcome Set-Standards for Development (COS-STAD) recommendations. Data extracted will include scope of the COS, health condition, interventions and outcome domains. Primary outcomes will be all core domains recommended within each COS. We define a common core outcome domain as one present in at least 67% of all COSs. All findings will be summarized and presented using descriptive statistics. DISCUSSION: This systematic review of COSs will describe the core domains recommended within each musculoskeletal COS. Common domains found may be used in the initial stages of development of future musculoskeletal COSs. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021239141.

Systematic review: preoperative psychological factors and total hip arthroplasty outcomes.

BACKGROUND: Total hip arthroplasties (THA) are cost-effective interventions for patients with osteoarthritis refractory to physical therapy or medical management. Most individuals report positive surgical outcomes with reduction in pain and improved joint function. Multiple recent studies demonstrated the influence of patient mental health on surgical success. We sought to determine the relationship between patient preoperative psychological factors and postoperative THA outcomes, specifically pain and function. METHODS: PubMed, EMBASE and Cochrane Reviews databases were queried using terms "(mental OR psychological OR psychiatric) AND (function OR trait OR state OR predictor OR health) AND (outcome OR success OR recovery OR response) AND total joint arthroplasty)." A total of 21 of 1,286 studies fulfilled inclusion criteria and were included in the review. All studies were analyzed using GRADE and Risk of Bias criteria. RESULTS: Overall, compared to cohorts with a normal psychological status, patients with higher objective measures of preoperative depression and anxiety reported increased postoperative pain, decreased functionality and greater complications following THA. Additionally, participants with lower self-efficacy or somatization were found to have worse functional outcomes. CONCLUSIONS: Preoperative depression, anxiety and somatization may negatively impact patient reported postoperative pain, functionality and complications following THA. Surgeons should consider preoperative psychological status when counseling patients regarding expected surgical outcomes.

Nutritionist Referral Modestly Improves Weight Loss and Increases Surgery Rate in Obese Patients Seeking Total Joint Arthroplasty.

Background: Obesity is associated with increased complications after total joint arthroplasty (TJA), leading some surgeons to recommend nutrition counseling and weight loss. We aim to evaluate the effect of preoperative nutritionist referral on weight loss and likelihood of surgery in obese patients seeking primary TJA. Methods: A retrospective cohort of patients seeking primary TJA who were referred to a licensed nutritionist for weight loss was matched by age, sex, and body mass index (BMI) to an unreferred control group. BMI change was compared between groups up to 1 year of follow-up. Differences were determined using 2-tailed t-tests and chi-squared tests with a significance cutoff of P < .05. Results: A total of 274 referred patients and 174 controls were included in our analysis. Patients who were referred to a nutritionist achieved significantly greater average BMI change (-1.5 kg/m2) than controls (-0.8 kg/m2) by 6 months after first contact (P = .01) although significance was lost at 1 year after first contact (P = .21). Thirty-eight percent of referred patients went on to TJA compared with 28% of controls (P < .01). Conclusions: Referral to a licensed nutritionist modestly improves early weight loss and is associated with a higher rate of surgery in obese patients seeking primary TJA.

Study protocol for developing, piloting and disseminating the PRISMA-COSMIN guideline: a new reporting guideline for systematic reviews of outcome measurement instruments.

BACKGROUND: Systematic reviews of outcome measurement instruments are important tools in the evidence-based selection of these instruments. COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) has developed a comprehensive and widespread guideline to conduct systematic reviews of outcome measurement instruments, but key information is often missing in published reviews. This hinders the appraisal of the quality of outcome measurement instruments, impacts the decisions of knowledge users regarding their appropriateness, and compromises reproducibility and interpretability of the reviews' findings. To facilitate sufficient, transparent, and consistent reporting of systematic reviews of outcome measurement instruments, an extension of the PRISMA (Preferred Reporting of Items for Systematic reviews and Meta-Analyses) 2020 guideline will be developed: the PRISMA-COSMIN guideline. METHODS: The PRISMA-COSMIN guideline will be developed in accordance with recommendations for reporting guideline development from the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network. First, a candidate reporting item list will be created through an environmental literature scan and expert consultations. Second, an international Delphi study will be conducted with systematic review authors, biostatisticians, epidemiologists, psychometricians/clinimetricians, reporting guideline developers, journal editors as well as patients, caregivers, and members of the public. Delphi panelists will rate candidate items for inclusion on a 5-point scale, suggest additional candidate items, and give feedback on item wording and comprehensibility. Third, the draft PRISMA-COSMIN guideline and user manual will be iteratively piloted by applying it to systematic reviews in several disease areas to assess its relevance, comprehensiveness, and comprehensibility, along with usability and user satisfaction. Fourth, a consensus meeting will be held to finalize the PRISMA-COSMIN guideline through roundtable discussions and voting. Last, a user manual will be developed and the final PRISMA-COSMIN guideline will be disseminated through publications, conferences, newsletters, and relevant websites. Additionally, relevant journals and organizations will be invited to endorse and implement PRISMA-COSMIN. Throughout the project, evaluations will take place to identify barriers and facilitators of involving patient/public partners and employing a virtual process. DISCUSSION: The PRISMA-COSMIN guideline will ensure that the reports of systematic reviews of outcome measurement instruments are complete and informative, enhancing their reproducibility, ease of use, and uptake.

Neurostimulation as an Efficacious Nonpharmacologic Analgesic following Arthroscopic Rotator Cuff Repair.

This case highlights the importance of pursuing nonpharmacologic analgesic modalities in orthopedic surgery to combat the current opioid epidemic. Presented is a patient who underwent an arthroscopic rotator cuff repair and biceps tenodesis operation and through the use of neurostimulation (in the form of auricular electrostimulation), fully recovered from surgery without the usage of any opioid or nonsteroidal anti-inflammatory medications. The patient was fitted with a novel auricular electrostimulation device (DyAnsys Primary Relief) in the immediate postoperative period that provided constant neurostimulation for 10 days, this neurostimulator was the only analgesic modality used in this case, and the patient reported minimal postoperative pain. The utility of this case centers around the lack of postoperative opioid use, presenting the idea that postsurgical orthopedic pain can be managed in a nonpharmacologic capacity, combatting the fields' ongoing opioid epidemic.

Do Patients Accurately Recall Their Pain Levels Following Epidural Steroid Injection? A Cohort Study of Recall Bias in Patient-Reported Outcomes.

BACKGROUND: Although patient-reported outcomes (PROs) have become important in the evaluation of spine surgery patients, the accuracy of patient recall of pre- or post-intervention  symptoms following epidural steroid injection remains unknown. OBJECTIVES: The purpose of this study was to: 1) characterize the accuracy of patient recollection of back/leg pain following epidural steroid injection; 2) characterize the direction and magnitude of recall bias; and 3) characterize factors that impact patient recollection. STUDY DESIGN: A prospective cohort study. SETTING: Level 1 Academic Medical Center. METHODS: Using standardized questionnaires, we recorded numeric pain scores for patients undergoing lumbar epidural steroid injections at our institution. Baseline pain scores were obtained prior to injection, 4-hours and 24-hours postinjection. At a minimum of 2 weeks following the injection, patients were asked to recall their symptoms preinjection and at 4 hours and 24-hours postinjection. Actual and recalled scores, at each time point, were compared using paired t tests. Multivariable linear regression was used to identify factors that impacted recollection. RESULTS: Sixty-one patients with a mean age of 61.4 years (56% women) were included. Compared to their preinjection pain score, patients showed considerable improvement at both 4 hours (Mean Difference [MD] = 2.18, 95% Confidence Interval [CI] 1.42 to 2.94) and 24 hours (MD = 2.64, 95% CI 1.91 to 3.34) postinjection. Patient recollection of preinjection symptoms was significantly more severe than actual at the 2-week time point (MD = 1.39, 95% CI 4.82 to 6.08). The magnitude of recall bias was mild and exceeded the minimal clinically important difference (MCID). No significant recall bias was noted on patient recollection of postinjection symptoms at 4 hours (MD = 0.41, 95% CI -1.05 to 0.23). Patient recollection of symptoms was also significantly more severe than actual at 24 hours (MD = 0.63, 95% CI -1.17 to -0.07), mild magnitude of bias that did not exceed MCID. Linear regression models for differences between actual and recalled pain scores reveal that for recall at 4 hours postinjection, older patients were better at recalling pain. LIMITATIONS: Baseline pain scores were completed in person, in front of a provider. The short-term pain scores were completed while at home, and then recalled scores were obtained by phone call encounter. Telephone surveys can lead to interview bias. All patients received incentive for completion of study. It is unclear if patient incentives have any impact on patient recall. Patients were contacted 2 weeks postinjection; this time point is standard at our institution, but could vary depending on practice location. Lastly, the enrolled patients did not all share the same indication for injection, and pain was not stratified between back and leg pain. CONCLUSIONS: Relying on patient recollection does not provide an accurate measure of preinjection status after lumbar epidural steroid injection, although patients did recall their 4-hour postinjection status. These findings support previous studies indicating that relying on patient recollection does not provide an accurate measure of preintervention symptoms. Patient recollection of postintervention symptoms, however, may have some clinical utility and requires further study.

Pelvic fixation is not always necessary in children with cerebral palsy scoliosis treated with growth-friendly instrumentation.

PURPOSE: A previous study showed that patients with neuromuscular scoliosis who underwent fusion to L5 had excellent coronal curve correction and improvement in pelvic obliquity (PO) when preoperative L5 tilt was < 15°. Our purpose was to identify indications to exclude the pelvis in children with cerebral palsy (CP) scoliosis treated with growing-friendly instrumentation. METHODS: In a retrospective cohort study, children with CP scoliosis treated with TGR, MCGR, or VEPTR with minimum 2-year follow-up were identified from a multicenter database. RESULTS: 27 patients with distal spine anchors (DSA) and 71 patients with distal pelvic anchors (DPA) placed at the index surgery were analyzed. The DSA group had a lower pre-index PO (9° vs 16°, P = 0.0001). Most recent radiographic data were similar except the DSA patients had a smaller major curve (47° vs 58°, P = 0.038). 6 (22%) DSA patients underwent extension of the instrumentation to the pelvis (DSA-EXT), most commonly at final fusion (5 patients). DSA-EXT patients had a higher pre-index L5 tilt than patients who did not require extension (DSA-NO EXT) (19° vs 10°, P = 0.009). Sub-analysis showed a lower major curve at most recent follow-up in the DSA-EXT group compared to the DPA group (33° vs 58°, P = 0.021). The DSA-EXT group had a higher number of complications per patient compared to the DSA-NO EXT group (2.3 vs 1.1, P = 0.029). CONCLUSION: Pre-index L5 tilt ≤ 10° and PO < 10° may be indications to exclude the pelvis in children with CP scoliosis treated with growth-friendly instrumentation. DSA may provide better long-term control of the major curve than DPA.

Incidence of Subsequent Surgical Intervention at Short-term Follow-up in Previously Healing and Stable Juvenile Osteochondritis Dissecans of the Knee.

BACKGROUND: Juvenile osteochondritis dissecans (OCD) of the knee is a defect of subchondral bone seen primarily in active children and adolescents. Studies have evaluated the incidence of surgery in knee OCD, but the incidence of subsequent surgery in patients with stable, healing lesions cleared to return to activities is unknown. This study sought to determine the incidence of surgery in participants with knee OCD lesions cleared to return to activities and evaluate predictors of subsequent surgery. METHODS: A single center, retrospective review was performed of participants aged 7 to 18 with knee OCD. Inclusion criteria were stable lesion, skeletal immaturity, no history of previous knee surgery, release to activity without surgery, and at least 12 months of follow-up. Documentation of subsequent surgery was queried in the electronic health record. Participants with no recorded surgery were contacted through phone. Analysis included bivariate and logistic regression. RESULTS: Twenty-five individuals were included in this study, with 7 undergoing surgery after returning to activity. Medial femoral condyle lesions were less likely to undergo surgery (B=-2.6, P=0.038). Average lesion size for the Surgery and No Surgery groups was 1.76±0.65 and 1.32±0.81 cm2, respectively, though not significantly different (P=0.21). The Surgery group returned to activity sooner (3.7 mo, range 1.1 to 6.4) than the No Surgery group (8.1 mo, range 1.8 to 35.4), though not significantly different (P=0.18). Mean follow-up time for the study was 42.7 (range 12.6 to 77.6) months. No participants contacted by phone progressed to surgery or reported symptoms that limited their activities. CONCLUSIONS: While the majority of participants with stable, healing, and asymptomatic knee OCD lesions have favorable outcomes with nonoperative management, some lesions may progress to surgery. Lesions on the medial femoral condyle may be predictive of lower likelihood of progression to surgery. Our study provides insight on the outcomes of nonoperative management of OCD lesions. LEVEL OF EVIDENCE: Level IV-prognostic study.

Risk Factors for COVID-19 in College Students Identified by Physical, Mental, and Social Health Reported During the Fall 2020 Semester: Observational Study Using the Roadmap App and Fitbit Wearable Sensors.

BACKGROUND: The COVID-19 pandemic triggered a seismic shift in education to web-based learning. With nearly 20 million students enrolled in colleges across the United States, the long-simmering mental health crisis in college students was likely further exacerbated by the pandemic. OBJECTIVE: This study leveraged mobile health (mHealth) technology and sought to (1) characterize self-reported outcomes of physical, mental, and social health by COVID-19 status; (2) assess physical activity through consumer-grade wearable sensors (Fitbit); and (3) identify risk factors associated with COVID-19 positivity in a population of college students prior to release of the vaccine. METHODS: After completing a baseline assessment (ie, at Time 0 [T0]) of demographics, mental, and social health constructs through the Roadmap 2.0 app, participants were instructed to use the app freely, wear the Fitbit, and complete subsequent assessments at T1, T2, and T3, followed by a COVID-19 assessment of history and timing of COVID-19 testing and diagnosis (T4: ~14 days after T3). Continuous measures were described using mean (SD) values, while categorical measures were summarized as n (%) values. Formal comparisons were made on the basis of COVID-19 status. The multivariate model was determined by entering all statistically significant variables (P<.05) in univariable associations at once and then removing one variable at a time through backward selection until the optimal model was obtained. RESULTS: During the fall 2020 semester, 1997 participants consented, enrolled, and met criteria for data analyses. There was a high prevalence of anxiety, as assessed by the State Trait Anxiety Index, with moderate and severe levels in 465 (24%) and 970 (49%) students, respectively. Approximately one-third of students reported having a mental health disorder (n=656, 33%). The average daily steps recorded in this student population was approximately 6500 (mean 6474, SD 3371). Neither reported mental health nor step count were significant based on COVID-19 status (P=.52). Our analyses revealed significant associations of COVID-19 positivity with the use of marijuana and alcohol (P=.02 and P=.046, respectively) and with lower belief in public health measures (P=.003). In addition, graduate students were less likely and those with ≥20 roommates were more likely to report a COVID-19 diagnosis (P=.009). CONCLUSIONS: Mental health problems were common in this student population. Several factors, including substance use, were associated with the risk of COVID-19. These data highlight important areas for further attention, such as prioritizing innovative strategies that address health and well-being, considering the potential long-term effects of COVID-19 on college students. TRIAL REGISTRATION: ClinicalTrials.gov NCT04766788; https://clinicaltrials.gov/ct2/show/NCT04766788. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/29561.

Cannabidiol Product Dosing and Decision-Making in a National Survey of Individuals with Fibromyalgia.

Many people with fibromyalgia use cannabidiol (CBD) products despite limited rigorous evidence of benefit. In the current study, we conducted a secondary analysis of a cross-sectional survey of N = 878 people with fibromyalgia to investigate naturalistic decision making around CBD product choices, use patterns, and dosing. We subgrouped participants based on use of high-THC cannabis (HTC) in the past year (yes/no) as previous studies have shown that HTC use influences CBD use patterns. The study population was largely female (93.6%), white (91.5%) and 55.5 years old on average. Participants typically purchased CBD products online or at dispensaries, with purchasing driven by personal research (63%) rather than endorsement from medical professionals (16%). Overall, tinctures and topicals were the most common administration routes endorsed. However, participants in the past-year HTC group used inhalation routes far more frequently than those who did not (39.8% vs 7.1%). Among participants using CBD tinctures or edibles, the average dose per session was 16 mg and 24 to 27 mg per day, although approximately one-third of participants did not know what dose of CBD they used. Participants using both inhalation and non-inhalation administration routes reported greater symptom relief than those using non-inhalation routes alone. However, there was no consistent relationship between CBD dose and reported effects, possibly due to expectancy effects around CBD products or interindividual variability. Our granular investigation reveals variability of CBD product dosing practices for fibromyalgia, and how past-year HTC use influences CBD product use. Future clinical trials should investigate the potential benefits of low-dose (<50mg) botanical CBD products. PERSPECTIVE: This article shows that past-year HTC use strongly influences how people with fibromyalgia choose and use CBD products. Participants typically used <50 mg/d of CBD, and there was no relationship between higher CBD dose and reported therapeutic benefit. Future clinical trials should investigate therapeutic benefits of low dose CBD.

Reduction in opioid use with perioperative non-pharmacologic analgesia in total knee arthroplasty and ACL reconstruction: a systematic review.

INTRODUCTION: The world's opioid epidemic has gotten increasingly severe over the last several decades and projects to continue worsening. Orthopedic surgery is the largest contributor to this epidemic, accounting for 8.8% of postoperative opioid dependence cases. Total knee arthroplasty (TKA) and anterior cruciate ligament (ACL) reconstruction are commonly performed orthopedic operations heavily reliant on opioids as the primary analgesic in the peri- and immediate postoperative period. These downfalls highlight the pressing need for an alternate, non-pharmacologic analgesic to reduce postoperative opioid use in orthopedic patients. The presented systematic review aimed to analyze and compare the most promising non-pharmacologic analgesic interventions in the available literature to guide future research in such a novel field. METHODS: A systematic search of PubMed, MEDLINE, Embase, Cochrane, and Web of Science was performed for studies published before July 2020 based on the PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines, and the obtained manuscripts were evaluated for inclusion or exclusion against strict, pre-determined criteria. Risk-of-bias and GRADE (grades of recommendation, assessment, development, and evaluation) assessments were then performed on all included studies. RESULTS: Six studies were deemed fit for inclusion, investigating three non-pharmacologic analgesics: percutaneous peripheral nerve stimulation, cryoneurolysis, and auricular acupressure. All three successfully reduced postoperative opioid use while simultaneously maintaining the safety and efficacy of the procedure. DISCUSSION: The results indicate that all three presented non-pharmacologic analgesic interventions are viable and warrant future research. That said, because of its slight advantages in postoperative pain control and operational outcomes, cryoneurolysis seems to be the most promising. Further research and eventual clinical implementation of these analgesics is not only warranted but should be a priority because of their vast potential to reduce orthopedics surgeries' contribution to the opioid epidemic.

Which outcomes are most important to measure in patients with COVID-19 and how and when should these be measured? Development of an international standard set of outcomes measures for clinical use in patients with COVID-19: a report of the International Consortium for Health Outcomes Measurement (ICHOM) COVID-19 Working Group.

OBJECTIVES: The COVID-19 pandemic has resulted in widespread morbidity and mortality with the consequences expected to be felt for many years. Significant variation exists in the care even of similar patients with COVID-19, including treatment practices within and between institutions. Outcome measures vary among clinical trials on the same therapies. Understanding which therapies are of most value is not possible unless consensus can be reached on which outcomes are most important to measure. Furthermore, consensus on the most important outcomes may enable patients to monitor and track their care, and may help providers to improve the care they offer through quality improvement. To develop a standardised minimum set of outcomes for clinical care, the International Consortium for Health Outcomes Measurement (ICHOM) assembled a working group (WG) of 28 volunteers, including health professionals, patients and patient representatives. DESIGN: A list of outcomes important to patients and professionals was generated from a systematic review of the published literature using the MEDLINE database, from review of outcomes being measured in ongoing clinical trials, from a survey distributed to patients and patient networks, and from previously published ICHOM standard sets in other disease areas. Using an online-modified Delphi process, the WG selected outcomes of greatest importance. RESULTS: The outcomes considered by the WG to be most important were selected and categorised into five domains: (1) functional status and quality of life, (2) mental functioning, (3) social functioning, (4) clinical outcomes and (5) symptoms. The WG identified demographic and clinical variables for use as case-mix risk adjusters. These included baseline demographics, clinical factors and treatment-related factors. CONCLUSION: Implementation of these consensus recommendations could help institutions to monitor, compare and improve the quality and delivery of care to patients with COVID-19. Their consistent definition and collection could also broaden the implementation of more patient-centric clinical outcomes research.