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.

Predictors of clinical outcomes after non-operative management of symptomatic full-thickness rotator cuff tears.

BACKGROUND: Previous studies have shown that non-surgical management can be an effective treatment strategy for many patients with rotator cuff tears. Despite the prevalence of rotator cuff disease, few studies have examined the patient and tear related factors that predict outcomes of nonsurgical management in this cohort of patients. AIM: To identify factors that are associated with changes in patient reported outcomes over time in individuals with full-thickness rotator cuff tears treated without surgery. METHODS: A cohort of 59 patients who underwent non-surgical management of full thickness rotator cuff tears with a minimum of 1-year follow-up were identified from our institutional registry. Patient demographics, comorbidities and tear characteristics were collected at initial presentation. Outcome measures were collected at baseline and at each clinical follow-up, which included Western Ontario Rotator Cuff (WORC) index, American Shoulder and Elbow Surgeons score, Visual Analog Scale for pain and Single Assessment Numerical Evaluation. Multi- and univariate regression analyses were used to determine the impact of each patient and tear related variable on final WORC scores and change in WORC scores throughout the study. RESULTS: In this non-surgical cohort, all patient-reported outcome measures significantly improved compared to baseline at 1 and 2-year follow-up. There was no significant difference in outcomes between 1 and 2 years. The average improvement surpassed the published minimal clinically important differences values for WORC, American Shoulder and Elbow Surgeons, Visual Analog Scale pain and Single Assessment Numerical Evaluation scores. Regression analysis identified female gender (ß = - 19.88, P = 0.003), smoking (ß = -29.98, P = 0.014) and significant subscapularis fatty infiltration (ß = -15.35, P = 0.024) as predictors of less favorable WORC scores at 1 year, and female gender (ß = -19.09, P = 0.015) alone as a predictor of lower WORC scores at 2 years. Patients with symptom duration greater than 1 year at presentation reported less improvement in WORC scores at 1-year follow-up (ß = -14.63, P = 0.052) and patients with traumatic tears reported greater improvements in WORC scores at 2-year follow-up (ß = 17.37, P = 0.031). CONCLUSION: Patients with full thickness rotator cuff tears can achieve and maintain clinically meaningful benefit from non-surgical management through 2-year follow-up. Female patients, smokers, and those with significant subscapularis fatty infiltration tend to have lower overall WORC scores at 1-year follow-up, and females also have lower WORC scores at 2-year follow-up. Patients presenting with symptoms greater than 1 year had less clinical improvement at 1-year follow-up, and those with traumatic tears had greater clinical improvement at 2-year follow-up.

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.

Humeral Head Ossification Growth Prediction: Can This Method Be Reproduced?

BACKGROUND: Radiographically assessing skeletal maturity is of paramount importance to guide appropriate management for patients with adolescent idiopathic scoliosis. The reported advantages of the Humeral Head Ossification System (HHOS) are an even distribution around peak growth age (PGA), the presence of an optimal view of the humeral head in most scoliosis radiographs, and an interobserver and intraobserver reliability of 0.95 and 0.96, respectively. The goal of this study was to determine whether similar reliability could be achieved at an institution other than the one at which the HHOS was originally described. METHODS: Six raters used the HHOS to stage the humeral head on 30 deidentified posteroanterior spine radiographs. This process was repeated 2 weeks later. All raters were provided with a document demonstrating the radiographic parameters of each stage, as well as annotations to aid with classification. Intraclass coefficients were calculated. A secondary analysis was then performed grouping stages 1-2 as "pre-PGA" and 3-5 as "post-PGA." RESULTS: Fair to moderate interobserver and intraobserver reliability was achieved when determining each individual HHOS stage. This improved to good to excellent when the humeral was classified as pre-PGA or post-PGA. Subanalysis did not show any correlation between intraobserver reliability and level of orthopaedic experience. CONCLUSIONS: We found fair to moderate interobserver and intraobserver reliability with the HHOS and this was independent of level of orthopaedic experience. This is much lower than reported by the authors who developed the system, and suggests that the HHOS might not be as easy to incorporate into a scoliosis management algorithm as previously noted. The improved reliability achieved when staging the humeral head as pre-PGA or post-PGA might be the true benefit of this system. LEVEL OF EVIDENCE: Level III-diagnostic.

COSMIN reporting guideline for studies on measurement properties of patient-reported outcome measures.

PURPOSE: To develop a set of consensus and empirically based reporting recommendations for primary studies of the measurement properties of patient-reported outcome measures (PROMs). METHODS: This study included four phases: 1. Conducting an extensive literature review of recommendations for reporting of studies testing measurement properties of PROMs; 2. Preparing for the Delphi study by identifying experts; 3. Conducting three Delphi rounds aiming for consensus on the item list of recommendations found in phase 1; 4. Developing the COSMIN reporting guideline and user manual. RESULTS: The literature review resulted in 93 reporting items, included in the first Delphi round. A total of 84 individuals (from 12 countries) agreed to participate in the Delphi study, with 47, 30 and 25 responding in rounds one, two and three, respectively. After three rounds, we achieved consensus on a set of 71 items separated into a set of 35 "common" items (relevant to all studies on measurement properties) and 41 "specific" items (exclusively relevant to one of the nine measurement properties). CONCLUSION: Consensus was achieved on a set of 71 items for inclusion in a reporting guideline for studies on measurement properties of PROMs. These items will guide researchers on the necessary information to include in their reports of investigations of measurement properties of PROMs. This guideline will likely improve the completeness of reporting of these important studies.

Cannabidiol Use for Fibromyalgia: Prevalence of Use and Perceptions of Effectiveness in a Large Online Survey.

Cannabidiol (CBD) is widely advertised as helpful for chronic pain management but research is limited. Using a cross-sectional, anonymous survey, we examined patterns of naturalistic CBD use among individuals with fibromyalgia (FM) and other chronic pain conditions. Our objective was to better understand rates of CBD use, reasons for use and discontinuation, communication with healthcare professionals about CBD, and perceptions of CBD effectiveness and safety among people with FM. After excluding incomplete surveys, our study population consisted of N = 2,701 participants with fibromyalgia, primarily in the United States. Overall, 38.1% reported never using CBD, 29.4% reported past CBD use, and 32.4% reported current CBD use. Past-year cannabis use was strongly associated with past or current CBD use. Those using CBD typically did so due to inadequate symptom relief, while those not using CBD typically cited safety concerns as their reason for not using CBD. Two-thirds of participants disclosed CBD use to their physician, although only 33% asked for physician advice on using CBD. Participants used CBD for numerous FM-related symptoms (most commonly pain), and generally reported slight to much improvement across symptom domains. Around half of participants reported side effects, which were typically minor. Our findings are limited by selection bias and our cross-sectional design, which prevents causal associations. In conclusion, CBD use is common among individuals with FM and many individuals using CBD report improvements across numerous FM-related symptoms. Our findings highlight the need for additional rigorous studies to better understand CBD's potential for FM management. PERSPECTIVE: This article indicates that CBD use is common among people with fibromyalgia, and the results suggest that many derive benefit from using CBD across multiple symptoms domains. Clinicians should discuss CBD use with fibromyalgia patients, and future studies are needed to rigorously assess CBD's therapeutic value for fibromyalgia symptoms.

Association between switching of primary outcomes and reported trial findings among randomized drug trials from China.

BACKGROUND AND OBJECTIVE: To evaluate the association between the nature of findings and the switching of registered primary outcomes among randomized controlled trials (RCTs) from mainland China. METHODS: This is a retrospective cohort study. We retrieved RCTs from trial registries and identified the corresponding journal articles from bibliographic databases until August 2019. Trial registries and journal articles were compared to evaluate whether registered primary outcomes with negative findings were more likely to be switched to secondary outcomes in the subsequent journal articles than those with positive findings. RESULTS: Switching of registered primary outcomes occurred in 131 (45%) of 294 RCTs. A total of 450 registered primary outcomes were matched to 522 (37%) primary outcomes and 871 (63%) secondary outcomes in the journal articles. Among RCTs registered before they started, the odds of switching primary outcomes with negative findings were 2.64 (95% CI: 1.16-6.02) times the odds of switching those with positive findings. Among RCTs registered when they were ongoing, the odds of switching primary outcomes with negative findings were 8.84 (95% CI: 3.62-25.93) times the odds of switching those with positive findings. CONCLUSION: The nature of findings may play a role in how likely a prespecified primary outcome is switched subsequently.

Assessment of Duplicate Publication of Chinese-Sponsored Randomized Clinical Trials.

Importance: Duplicate publications of randomized clinical trials are prevalent in the health-related literature. To date, few studies have assessed the interaction between duplicate publication and the language of the original publication. Objective: To assess the existence of duplicate publication and the extent to which duplicate publication is associated with the language of the original publication. Design, Setting, and Participants: In this retrospective cohort study, eligible randomized clinical trials were retrieved from trial registries, and bibliographic databases were searched to determine their publication status. Eligible randomized clinical trials were for drug interventions from January 1, 2008, to December 31, 2014. The search and analysis were conducted from March 1 to August 31, 2019. The trial registries were either primary registries recognized by the World Health Organization or the Drug Clinical Trial Registry Platform sponsored by the China Food and Drug Administration. Exposures: Individual randomized clinical trials with positive vs negative results. Main Outcomes and Measures: Journal articles were classified as main articles (determined by largest sample size and longest follow-up among all journal articles derived from that randomized clinical trial) and duplicates. The duplicates were classified into 4 types: (1) unreferenced subgroup analysis (article did not disclose itself as a subgroup analysis or reference its main article); (2) unreferenced republication (article did not disclose itself as a replicate of the main article or reference it); (3) unreferenced interim analysis (article did not disclose itself as an interim analysis or reference its main article); and (4) partial duplicate (article did not disclose its sharing a subset of participants with other articles or reference them). Results: Among 470 randomized clinical trials published by August 2019 as journal articles, 55 (11.7%) had 75 duplicates, of which 53 (70.7%) were cross-language duplicates. Of the 75 duplicates, 33 (44.0%) were unreferenced republications, 25 (33.3%) unreferenced subgroup analyses, 15 (20.0%) unreferenced interim analyses, and 2 (2.7%) partial duplicates. When the main article of a randomized clinical trial was published in Chinese, those with positive findings were 2.48 (95% CI, 1.08-5.71) times more likely to have subsequent duplicate publication than those with negative findings. Conclusions and Relevance: In this study, most duplicates were cross-language duplicates and the most common type was unreferenced republication of the main article. Duplicate publication bias exists when the main articles of randomized clinical trials were published in Chinese, potentially misleading readers and compromising journals and evidence synthesis.