Vistisengilbert8723

OBJECTIVE To consider the acceptability and content validity of patient-reported outcome measures (PROMs) commonly used in rheumatoid arthritis (RA) by describing patients' perceptions of PROMs, and comparing patients' PROM responses with their verbal accounts of disease impacts. METHODS We used a sequential mixed methods approach, combining analysis of interviews and PROM data (HAQ, FACIT-F, EQ-5D, SF36, and VAS for pain, fatigue, sleep, and patient global). Qualitative analysis of patients' perceptions of PROMs informed a subsequent comparison between patients' PROM data and verbal accounts of pain, fatigue, sleep, and functional limitations to assess their effectiveness for communicating disease impact. RESULTS The study included eighteen patients. Although a few patients offered positive comments about PROMs, most doubted that PROMs could accurately convey their experience of symptoms and functional limitations. Patients discussed the ease of responding to questions, capturing and conveying symptoms, and concerns about the underreporting of symptoms and interpretation of responses. Compared with verbal accounts, PROMs often did not convey the personal significance of limitations; however, PROMs captured limitations that patients omitted or described with insufficient detail during interviews. Although verbal accounts of pain could be categorized into three levels of severity (pain without interference in activities, pain is not the worst ever experienced but interferes with activities, and pain is omnipresent), the pain VAS was more effective at conveying finer gradations in pain severity. CONCLUSION Although patients may feel that PROMs have certain shortcomings, PROMs also have advantages relative to verbal discussion for communicating symptoms and disease impact. © 2020, American College of Rheumatology.BACKGROUND Hypertensive disorders of pregnancy (HDP) increase cardiovascular disease (CVD) risk. Pregnancy morbidities, including preeclampsia, and CVD are common in systemic lupus erythematosus (SLE). Possible connections are important to explore. In a population-based cohort, we investigated whether HDP is associated with a higher risk of cardiovascular outcomes separately in SLE and non-SLE to examine the role of SLE. METHODS We identified first singleton births in the Medical Birth Register (1987-2012) among mothers with SLE and a large general population comparison group. Discharge diagnoses for HDP, cardiovascular outcomes, and hypertension in the Patient Register were identified using ICD codes. We estimated adjusted hazard ratios and 95% confidence intervals (HR, 95% CI) of the association between HDP and outcomes, in separate models in women with and without SLE. We then evaluated additive and multiplicative effect modification using relative excess risk due to interaction and Cox models jointly accounting for SLE and HDP, respectively. Mediation analysis estimated the proportion of the association between SLE and outcome explained by HDP. RESULTS HDP were more common in SLE pregnancies (20% vs 7%). In SLE, HDP were associated with a two-fold higher rate of cardiovascular outcomes and three-fold higher rate of incident hypertension. HDP mediated 20% of the latter association. In women without SLE, HDP was associated with higher hypertension incidence later in life. CONCLUSION In women with and without SLE, HDP were associated with a three-fold higher rate of hypertension. In SLE, women with HDP developed cardiovascular outcomes twice as often as women without HDP. © 2020, American College of Rheumatology.Efforts for sharing individual clinical data are gaining momentum due to a heightened recognition that integrated data sets can catalyze biomedical discoveries and drug development. Among the benefits are the fact that data sharing can help generate and investigate new research hypothesis beyond those explored in the original study. Despite several accomplishments establishing public systems and guidance for data sharing in clinical trials, this practice is not the norm. Among the reasons are ethical challenges, such as privacy of individuals, data ownership, and control. This paper creates awareness of the potential benefits and challenges of sharing individual clinical data, how to overcome these challenges, and how as a clinical pharmacology community we can shape future directions in this field. © 2020 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics.Japan's Advanced Medical Care Program (AMCP) seeks to facilitate patient access to promising healthcare technologies through National Health Insurance (NHI) coverage. This study aimed to examine AMCP's contribution to the accelerated introduction of new technologies through NHI coverage. AMCP-type B technologies registered May 2006-March 2019 were examined. To investigate the use of AMCP for NHI coverage, data from the AMCP website and from regulatory authority documents were used. Of 127 AMCP-type B technologies, 38 underwent final review. Fifteen technologies were successfully introduced into NHI coverage. Eight technologies introduced directly through the Advanced Medical Care Conference were related to medical devices. Other technologies, including drugs, required additional accelerated frameworks for market approval. A strategic approach with the careful selection of target therapeutic technologies and accelerated frameworks is key for the rapid introduction of medical technologies through AMCP. © 2020 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics.We appreciate the comments by Dr. Abeles [1] about our recent publication on anti-nuclear antibody (ANA, referred to as anti-cellular antibody (ACA) in our publication and in this response) negative sera in systemic lupus erythematosus (SLE) that utilized biobanked serum samples from the Systemic Lupus International Collaborating Clinics (SLICC) inception cohort [2]. selleck chemicals We concur with many of the comments and concerns, although we prefer to think that the issues raised are not so much "debatable" as requiring further study. © 2020, American College of Rheumatology.