Establishing the minimum clinically important difference of the Quality of Life in Childhood Epilepsy Questionnaire.

OBJECTIVE: To estimate the minimum clinically important difference (MCID) for the parent-reported 55-item Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55) and its shortened 16-item version, QOLCE-16. METHODS: Data came from 74 children with epilepsy (CWE) (ages 4-10, mean age = 8 [SD = 1.8]) enrolled in the Making Mindfulness Matter in Epilepsy (M3-E) trial, a pilot, parallel randomized-controlled trial of a mindfulness-based intervention. Both anchor-based and distribution-based methods were used to estimate MCID values for the QOLCE-55 and QOLCE-16. For the anchor-based approach, the Patient Centered Global Ratings of Change (PCGRC) scale and linear regression analysis were used to estimate the MCID. For the distribution-based approach, .5 SD of the health-related quality of life (HRQOL) change score distribution was used to estimate the MCID. RESULTS: For the QOLCE-55, the MCID obtained using an anchor-based approach was 10 points and using a distribution-based method was 6 points. For the QOLCE-16, the MCID obtained using an anchor-based method was 13 points and using a distribution-based method was 7 points. SIGNIFICANCE: This is the first study to estimate MCID values for the QOLCE-55 and the QOLCE-16. It has been well documented that CWE are at risk of experiencing psychological, behavioral, and cognitive impairments, which can negatively impact their HRQOL. Reporting MCID values for the QOLCE-55 and QOLCE-16 is important in determining whether changes in HRQOL observed are meaningful to CWE themselves, as a key factor in shaping the nature of epilepsy care delivered.

Psychometric properties of patient-reported outcome measures assessing recovery from hand fractures: a systematic review.

PURPOSE: To extensively review Patient Reported Outcome Measures (PROMs) used to assess outcomes in persons with hand fractures in terms of their psychometric properties. METHODS: A COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodological review was conducted. Six electronic databases were searched (Medline, Embase, Scopus, Web of Science, PsycINFO, CINAHL) for studies evaluating the psychometric properties of PROMs assessing recovery from hand fracture. Titles and abstracts, full text review, quality assessment and data extraction were performed by two reviewers. Any disagreements were resolved after review by a third, expert reviewer. Quality assessment of included studies was performed using the COSMIN checklist. RESULTS: This COSMIN review found that there were only 4 studies that fulfilled the inclusion criteria in terms of assessing measurement properties of PROMs in hand fractures. Only the construct validity of the Disabilities of the Arm, Shoulder, and Hand (DASH), the Quick DASH (QDASH) and the Duruoz Hand Index (DHI), and the responsiveness of the DASH, the Patient Specific Functional Scale (PSFS), the Patient-Rated Wrist and Hand Evaluation (PRWHE) and the Michigan Hand Outcomes Questionnaire (MHQ) were assessed in these studies. The overall rating of the studies was assessed as insufficient or indeterminate and quality of evidence was assessed as moderate, low, or very low by our team. CONCLUSIONS: This study identified that there is a lack of evidence in the medical literature with regards to the measurement properties of PROMs in patients with hand fractures. The 4 included studies do not provide good quality data to support the use of these PROMS in patients with hand fractures. There is a need for more studies for more PROMs. This has important consequences for how outcomes will be measured in clinical studies in hand research and in clinical practice.

Hand fractures are some of the most common types of fractures in adults. They affect patients in the short term with everyday activities and can have a long-term impact especially on people who use their hands a lot at work and at home. The recovery from a hand fracture, with whatever treatment, can be captured by questionnaires completed by patients at frequent time intervals. We looked at whether questionnaires, which could do so for these patients, have been assessed in previous studies. Even though this is an important topic, we only found a handful of studies which have done so, and these were not very robust in their assessment. This study indicates that there needs to be more work in the field which will be very helpful for clinical practice and future research.

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 Measurement 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 checklist 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 explanation 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. NOTE: In order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

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 Measurement 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 checklist 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 explanation 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. NOTE: In order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

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 Measurement 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 checklist 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 explanation 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. NOTE: In order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

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

BACKGROUND AND OBJECTIVE: 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 Measurement 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 checklist 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 explanation 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. NOTE: This paper was jointly developed by Journal of Clinical Epidemiology, Quality of Life Research, Journal of Patient Reported Outcomes, Health and Quality of Life Outcomes and jointly published by Elsevier Inc, Springer Nature Switzerland AG, and BioMed Central Ltd., part of Springer Nature. The articles are identical except for minor stylistic and spelling differences in keeping with each journal's style. Either citation can be used when citing this article.

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.

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.

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.

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.

A Call for a Standardized Approach to Reporting Patient-Reported Outcome Measures: Clinical Relevance Ratio.

ABSTRACT: A shift toward a value-driven health-care model has made prospective collection of patient-reported outcome measures (PROMs) inextricably tied to measuring the success of orthopaedic surgery and patient satisfaction. While progress has been made in optimizing the utilization of PROM data, including establishing appropriate PROMs for a procedure and determining the clinical importance of unique tools, if these PROMs are not accurately analyzed and reported, a proportion of patients who do not reach the clinical thresholds may go unnoticed. Furthermore, parameters are unclear for setting a statistically and clinically important PROM threshold along with a minimum period for follow-up data collection.In this forum, we walk through simulated data sets modeling PROMs with the example of total joint arthroplasty. We discuss how the commonly used method of reporting PROMs by mean change can overestimate the treatment effects for the cohort as a whole and fail to capture distinct populations that are below a clinically relevant threshold. We demonstrate that when a study's outcome is PROMs, clinical importance should be reported using clinical thresholds such as the minimum clinically important difference (MCID), the smallest change in the treatment outcome that a patient perceives as beneficial, and the patient acceptable symptom state (PASS), the highest level of symptoms beyond which a patient considers himself or herself well. Finally, we propose a standardized reporting of PROMs that incorporates both the MCID and the PASS, and introduce a "clinical relevance ratio," which relies on a clinically relevant threshold to dichotomize outcomes and reports the number of patients achieving clinical importance at a given time point divided by the total number of patients included in the study. Unlike other common PROM-reporting approaches, the clinical relevance ratio is not skewed by patients who are lost to follow-up with increased time.

Substituting Cannabidiol for Opioids and Pain Medications Among Individuals With Fibromyalgia: A Large Online Survey.

People report substituting cannabis for pain medications, but whether cannabidiol (CBD) is used similarly remains unknown. CBD products can be CBD alone (isolate), hemp extract (containing <0.3% Δ-9-tetrahydrocannabinol [THC], other cannabinoids, and terpenes), or CBD-cannabis (containing >0.3% THC). In a secondary analysis from a cross-sectional survey, we examined substitution patterns among n = 878 individuals with fibromyalgia who currently used CBD. We sub-grouped participants by most commonly used CBD product (CBD isolate, hemp, CBD-cannabis, no preference) and whether they substituted CBD for medications. We investigated rationale for substituting, substitution-driven medication changes, CBD use patterns, and changes in pain-related symptoms (eg, sleep, anxiety). The study population was 93.6% female and 91.5% Caucasian, with an average age of 55.5 years. The majority (n = 632, 72.0%) reported substituting CBD products for medications, most commonly NSAIDs (59.0%), opioids (53.3%), gabapentanoids (35.0%), and benzodiazepines (23.1%). Most substituting participants reported decreasing or stopping use of these pain medications. The most common reasons for substitution were fewer side effects and better symptom management. Age, hemp products, past-year use of marijuana, and higher somatic burden were all associated with substituting (P's ≤ .05). Those who substituted reported larger improvements in health and pain than those who did not. Participants using CBD-cannabis reported significantly more substitutions than any other group (P's ≤ .001) and larger improvements in health, pain, memory, and sleep than other subgroups. This widespread naturalistic substitution for pain medications suggests the need for more rigorous study designs to examine this effect. PERSPECTIVE: This article shows that people with fibromyalgia are deliberately substituting CBD products for conventional pain medications despite the dearth of evidence suggesting CBD products may be helpful for fibromyalgia. CBD's medication-sparing and therapeutic potential should be examined in more rigorous study designs.