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BackgroundThe impact and consequences of the COVID-19 pandemic on people with rheumatic disease are unclear. We developed the COVID-19 Global Rheumatology Alliance Patient Experience Survey to assess the effects of the COVID-19 pandemic on people with rheumatic disease worldwide.MethodsSurvey questions were developed by key stakeholder groups and disseminated worldwide through social media, websites, and patient support organisations. Questions included demographics, rheumatic disease diagnosis, COVID-19 diagnosis, adoption of protective behaviours to mitigate COVID-19 exposure, medication access and changes, health-care access and communication with rheumatologists, and changes in employment or schooling. Adults age 18 years and older with inflammatory or autoimmune rheumatic diseases were eligible for inclusion. We included participants with and without a COVID-19 diagnosis. We excluded participants reporting only non-inflammatory rheumatic diseases such as fibromyalgia or osteoarthritis.Findings12 117 responses to the survey were received between April 3 and May 8, 2020, and of these, 10 407 respondents had included appropriate age data. We included complete responses from 9300 adults with rheumatic disease (mean age 46·1 years; 8375 [90·1%] women, 893 [9·6%] men, and 32 [0·3%] participants who identified as non-binary). 6273 (67·5%) of respondents identified as White, 1565 (16·8%) as Latin American, 198 (2·1%) as Black, 190 (2·0%) as Asian, and 42 (0·5%) as Native American or Aboriginal or First Nation. The most common rheumatic disease diagnoses included rheumatoid arthritis (3636 [39·1%] of 9300), systemic lupus erythematosus (2882 [31·0%]), and Sjögren's syndrome (1290 [13·9%]). Most respondents (6921 [82·0%] of 8441) continued their antirheumatic medications as prescribed. Almost all (9266 [99·7%] of 9297) respondents adopted protective behaviours to limit SARS-CoV-2 exposure. A change in employment status occurred in 2524 (27·1%) of 9300) of respondents, with a 13·6% decrease in the number in full-time employment (from 4066 to 3514).InterpretationPeople with rheumatic disease maintained therapy and followed public health advice to mitigate the risks of COVID-19. Substantial employment status changes occurred, with potential implications for health-care access, medication affordability, mental health, and rheumatic disease activity.FundingAmerican College of Rheumatology.

BackgroundWe describe the early experiences of adults with systemic rheumatic disease who received the COVID-19 vaccine.MethodsFrom 2 April to 30 April 2021, we conducted an online, international survey of adults with systemic rheumatic disease who received COVID-19 vaccination. We collected patient-reported data on clinician communication, beliefs and intent about discontinuing disease-modifying antirheumatic drugs (DMARDs) around the time of vaccination, and patient-reported adverse events after vaccination.ResultsWe analysed 2860 adults with systemic rheumatic diseases who received COVID-19 vaccination (mean age 55.3 years, 86.7% female, 86.3% white). Types of COVID-19 vaccines were Pfizer-BioNTech (53.2%), Oxford/AstraZeneca (22.6%), Moderna (21.3%), Janssen/Johnson & Johnson (1.7%) and others (1.2%). The most common rheumatic disease was rheumatoid arthritis (42.3%), and 81.2% of respondents were on a DMARD. The majority (81.9%) reported communicating with clinicians about vaccination. Most (66.9%) were willing to temporarily discontinue DMARDs to improve vaccine efficacy, although many (44.3%) were concerned about rheumatic disease flares. After vaccination, the most reported patient-reported adverse events were fatigue/somnolence (33.4%), headache (27.7%), muscle/joint pains (22.8%) and fever/chills (19.9%). Rheumatic disease flares that required medication changes occurred in 4.6%.ConclusionAmong adults with systemic rheumatic disease who received COVID-19 vaccination, patient-reported adverse events were typical of those reported in the general population. Most patients were willing to temporarily discontinue DMARDs to improve vaccine efficacy. The relatively low frequency of rheumatic disease flare requiring medications was reassuring.

Purpose: This systematic survey evaluates the completeness of reporting in pilot and feasibility randomized controlled trials investigating behavioral interventions based on the Consolidated Standards of Reporting Trials (CONSORT) extension for pilot trials. Methods: The authors searched Medline/Pubmed and randomly selected 100 articles from 2012 through 2016 to determine the proportion of reported CONSORT extension items. They examined study factors related to reporting, including year and country of publication, psychotherapy intervention, multiple centers, industry funding, and journal endorsement of CONSORT. Results: The authors found that the mean reporting score on the CONSORT extension was 51.6% (SD = 15.1). Studies of psychotherapy interventions had significantly higher reporting scores than other interventions (incidence rate ratio = 1.10, 95% confidence interval: 1.01-1.20). Conclusions: Our findings indicate that current reporting quality is suboptimal. Many included trials failed to provide rationale for piloting, assess feasibility objectives, or indicate clear progression to a future large trial. Reporting quality should be reevaluated following uptake of the 2016 CONSORT extension for pilot trials. [Paper presented at the Stockholm Conference on Behavioral and Social Intervention Research, 11-12 May, 2017.]

Behavioral and social sciences randomized controlled trials (BSSTs) have a significant role in life sciences. Choosing an appropriate control or comparator group for BSSTs is critical, to provide true intervention effects. The objective of this study was to determine the types of control groups used in BSSTs, and the rationale provided to justify these choices. We conducted a systematic survey of BSST protocols published between January 2012 and October 2016 in the Cochrane Library and Medline databases. We randomly selected 200 protocols. The study selection and data extraction were performed independently in duplicate. The most frequent control groups were active concurrent (97/200, 48.5%), and no treatment concurrent controls (88/200, 44.0%). The majority of studies (71.5%) did not provide justification for comparators choice. We concluded that BSSTs trials compare interventions to active and no treatment controls however the majority of trials lacked rationale for the selection of the study comparator. [Paper presented at the Stockholm Conference on Behavioral and Social Intervention Research, 11-12 May, 2017.]

Introduction: Natural health products are frequently used by many people. However, many of these individuals do not discuss these products with their physicians, and instead seek information about the products from pharmacies or natural health product retailers. Previous research has shown that not all pharmacists are comfortable answering questions about these products as they receive little training in this area; natural health product retailers are unregulated and receive training at their own discretion. This study aimed to evaluate the accuracy of the information provided by pharmacies and natural health product retailers pertaining to use, adverse effects, and potential drug interactions for four currently popular products: garlic, peppermint, black licorice, and apple cider vinegar. Methods: The literature surrounding these products was reviewed and compared to information provided by pharmacies and natural health product retailers. The interviews were conducted by an investigator who presented as a potential client to closely mimic realworld interactions. Statistical analysis was limited to generating proportions and 95% confidence intervals for statements made about each product. Results: Overall, 10% of statements that were made regarding the uses for the four natural health products were consistent with the evidence-based literature, 40% of statements were consistent with the common use of the products, 47% of statements were inconsistent with the literature and 3% of statements reflected general opinions about the product. There was variation in the accuracy of statements depending on which product was discussed. When discussing adverse effects associated with the products 38% of statements made by pharmacists and 44% made by NHP retailers were consistent with the literature. Sixty-nine percent of pharmacists and 44% of NHP retailers correctly identified potential drug interactions for the products. Discussion: The majority of statements were consistent with common use but few evidence-based statements were made and a large proportion of statements that were inconsistent with literature were made. Most interviewees required prompting to discuss adverse effects and potential drug interactions. Conclusions: This study highlights a need for increased training of pharmacists and natural health product retailers to ensure that they are familiar with these popular natural health products and can provide accurate information to clients regarding use, adverse effects, and possible drug interactions. [ABSTRACT FROM AUTHOR]

The evidence base to support reimbursement decision making for oncology drugs is often based on short-term follow-up trial data, and attempts to address this uncertainty are not typically undertaken once a reimbursement decision is made. To address this gap, we sought to conduct a reassessment of an oncology drug (pembrolizumab) for patients with advanced melanoma which was approved based on interim data with a median 7.9 months of follow-up and for which long-term data have since been published. We developed a three-health-state partitioned survival model based on the phase 3 KEYNOTE-006 clinical trial data using patient-level data reconstruction techniques based on an interim analysis. We used a standard survival analysis and parametric curve fitting techniques to extrapolate beyond the trial follow-up time, and the model structure and inputs were derived from the literature. Five-year long-term follow-up data from the trial were then used to re-evaluate the cost-effectiveness of pembrolizumab versus ipilimumab for treatment of advanced melanoma. The best fitting parametric curves and corresponding survival extrapolations for reconstructed interim data and long-term data reconstructed from KEYNOTE-006 were different. An analysis of the 5 year long-term follow-up data generated a base case incremental cost-effectiveness ratio (ICER) that was 28% higher than the ICER based on interim trial data. Our findings suggest that there may be a trade-off between certainty and the ICER. Conducting health technology re-assessments of certain oncology products on the basis of longer-term data availability, especially for those health technology adoption decisions made based on immature clinical data, may be of value to decision makers. [ABSTRACT FROM AUTHOR]