Addressing the challenges of integrating digital health technologies to measure patient-centred outcomes in clinical registries.

Longitudinal patient registries generate important evidence for advancing clinical care and the regulatory evaluation of health-care products. Most national registries rely on data collected as part of routine clinical encounters, an approach that does not capture real-world, patient-centred outcomes, such as physical activity, fatigue, ability to do daily tasks, and other indicators of quality of life. Digital health technologies that obtain such real-world data could greatly enhance patient registries but unresolved challenges have so far prevented their broad adoption.

Day-to-day variability of knee pain and the relationship with physical activity in people with knee osteoarthritis: an observational, feasibility study using consumer smartwatches.

Objective: To assess the feasibility of using smartwatches in people with knee osteoarthritis (OA) to determine the day-to-day variability of pain and the relationship between daily pain and step count.

Design: Observational, feasibility study.

Setting: In July 2017, the study was advertised in newspapers, magazines and, on social media.

Heart rate variability is markedly abnormal following surgical repair of atrial and ventricular septal defects in pediatric patients.

Background: Abnormalities in heart rate variability (HRV) have been associated with increased morbidity and mortality. Adults with a history of successful correction of atrial septal defects (ASDs) and ventricular septal defects (VSDs) have clinically relevant abnormalities in HRV. The etiology of these abnormalities is unknown as is when they occur in the natural history of these lesions.

Understanding the Predictors of Missing Location Data to Inform Smartphone Study Design: Observational Study.

Background: Smartphone location data can be used for observational health studies (to determine participant exposure or behavior) or to deliver a location-based health intervention. However, missing location data are more common when using smartphones compared to when using research-grade location trackers. Missing location data can affect study validity and intervention safety.

Public Perspectives of Using Social Media Data to Improve Adverse Drug Reaction Reporting: A Mixed-Methods Study.

Introduction: Information on suspected adverse drug reactions (ADRs) voluntarily submitted by patients can be a valuable source of information for improving drug safety; however, public awareness of reporting mechanisms remains low. Whilst methods to automatically detect ADR mentions from social media posts using text mining techniques have been proposed to improve reporting rates, it is unclear how acceptable these would be to social media users.

Objective: The objective of this study was to explore public opinion about using automated methods to detect and report mentions of ADRs on social media to enhance pharmacovigilance efforts.

Multinational comparison of new antidepressant use in older adults: a cohort study.

Objectives: We used an international pharmacosurveillance network to estimate the rate and characteristics of antidepressant use in older adults in countries with more conservative (UK) and liberal depression guidelines (Canada, USA).

Setting: Electronic health records and population-based administrative data from six jurisdictions in four countries (UK, Taiwan, USA and Canada).

Participants: A historical cohort of older adults (≥65 years) who had a new episode of antidepressant use between 2009 and 2014.

Quality of life, sleep and rheumatoid arthritis (QUASAR): a protocol for a prospective UK mHealth study to investigate the relationship between sleep and quality of life in adults with rheumatoid arthritis.

Introduction: People with rheumatoid arthritis (RA) frequently report reduced health-related quality of life (HRQoL), the impact one's health has on physical, emotional and social well-being. There are likely numerous causes for poor HRQoL, but people with RA have identified sleep disturbances as a key contributor to their well-being. This study will identify sleep/wake rhythm-associated parameters that predict HRQoL in patients with RA.

A threshold hazard model for estimating serious infection risk following anti-tumor necrosis factor therapy in rheumatoid arthritis patients.

Over recent years novel biologic agents have been developed for the treatment of rheumatoid arthritis. The most common type of biologic agent in use in the United Kingdom is the anti-tumor necrosis factor inhibitor class. To fully appreciate the potential risks of anti-tumor necrosis factor therapy in patients, knowledge about the baseline hazard (risk pattern) and the characteristics of patients associated with serious infection is important.

The safety of anti-tumour necrosis factor therapy in rheumatoid arthritis.

Purpose Of Review: Anti-tumour necrosis factor therapy has proven effective as treatment against a series of autoimmune inflammatory diseases, and has displayed a rapidly increasing market penetration. The safety profile of these drugs is, however, both uncertain and debated, in particular with respect to infections and malignancy. Lack of uniform definitions and methods of analysis makes it difficult to directly compare data from randomized controlled trials, meta-analyses of trials, open-label extensions, data from spontaneous reporting, and particularly, observational cohort studies.

Is there an association between anti-TNF monoclonal antibody therapy in rheumatoid arthritis and risk of malignancy and serious infection? Commentary on the meta-analysis by Bongartz et al.

A recent meta-analysis of randomized clinical trials reported by Bongartz and coworkers raised concerns about an increased rate of malignancy and serious infection in rheumatoid arthritis patients treated with anti-tumour necrosis factor monoclonal antibodies. This commentary discusses some of the methodological issues in their analysis and urges caution in interpreting the results.