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Objective: Self‐monitored point‐of‐care urate‐measuring devices are an underexplored strategy to improve adherence to urate‐lowering therapy and clinical outcomes in gout. This study observed patient‐led urate self‐monitoring practice and assessed its influence on allopurinol adherence, urate control, and health‐related quality of life. Methods: People with gout (n = 31) and prescribed allopurinol self‐monitored their urate concentrations (HumaSens2.0plus) at baseline and thereafter monthly for 12 months (3 months per quarter). Adherence to allopurinol was measured using medication event monitoring technology (Medication Event Monitoring System cap). Time spent below the target urate concentration (<0.36 mmol/L) was determined. Health‐related quality of life was measured using a survey (EuroQoL EQ‐5D‐5L). Gout flares were recorded. Two‐tailed Spearman correlation and the Wilcoxon matched‐pairs signed‐rank test (P < 0.05) were used for statistical comparisons. Results: Most participants were male (94%) and had urate concentrations below the target (74%) at baseline. Overall, seven participants demonstrated repeated periods of "missed doses" (two or fewer allopurinol doses missed consecutively) and "drug holidays" (three or more missed doses). Most participants (94%) persisted with allopurinol. Time spent within the target urate concentration increased 1.3‐fold (from 79% to 100%; P = 0.346), and the incidence of gout flares decreased 1.6‐fold (from 8 to 5; P = 0.25) in the final quarter compared to that in the first quarter of the study. Health‐related quality of life was reduced for participants reporting at least one gout flare (median utility values 0.9309 vs 0.9563, P = 0.04). Conclusion: Patient‐led urate self‐monitoring may support the maintenance of allopurinol adherence and improve urate control, thus reducing the incidence of gout flares. Further research on patient‐led urate self‐monitoring in a randomized controlled study is warranted. [ABSTRACT FROM AUTHOR]

Introduction: Gout management remains suboptimal despite safe and effective urate‐lowering therapy. Self‐monitoring of urate may improve gout management, however, the acceptability of urate self‐monitoring by people with gout is unknown. The aim of this study was to explore the experiences of urate self‐monitoring in people with gout. Methods: Semistructured interviews were conducted with people taking urate‐lowering therapy (N = 30) in a 12‐month trial of urate self‐monitoring in rural and urban Australia. Interviews covered the experience of monitoring and its effect on gout self‐management. Deidentified transcripts were analysed thematically. Results: Participants valued the ability to self‐monitor and gain more understanding of urate control compared with the annual monitoring ordered by their doctors. Participants indicated that self‐monitoring at home was easy, convenient and informed gout self‐management behaviours such as dietary modifications, hydration, exercise and medication routines. Many participants self‐monitored to understand urate concentration changes in response to feeling a gout flare was imminent or whether their behaviours, for example, alcohol intake, increased the risk of a gout flare. Urate concentrations were shared with doctors mainly when they were above target to seek management support, and this led to allopurinol dose increases in some cases. Conclusion: Urate self‐monitoring was viewed by people with gout as convenient and useful for independent management of gout. They believed self‐monitoring achieved better gout control with a less restricted lifestyle. Urate data was shared with doctors at the patient's discretion and helped inform clinical decisions, such as allopurinol dose changes. Further research on implementing urate self‐monitoring in routine care would enable an evaluation of its impact on medication adherence and clinical outcomes, as well as inform gout management guidelines. Patient or Public Contribution: One person with gout, who was not a participant, was involved in the study design by providing feedback and pilot testing the semistructured interview guide. In response to their feedback, subsequent modifications to the interview guide were made to improve the understandability of the questions from a patient perspective. No additional questions were suggested. [ABSTRACT FROM AUTHOR]

Background: Delayed response to clinical deterioration of hospital inpatients is common. Deployment of an electronic automated advisory vital signs monitoring and notification system to signal clinical deterioration is associated with significant improvements in clinical outcomes but there is no evidence on the cost-effectiveness compared with routine monitoring, in the National Health Service (NHS) in the United Kingdom (UK). Methods: A decision analytic model was developed to estimate the cost-effectiveness of an electronic automated advisory notification system versus standard care, in adults admitted to a district general hospital. Analyses considered: (1) the cost-effectiveness of the technology based on secondary analysis of patient level data of 3787 inpatients in a before-and-after study; and (2) the cost-utility (cost per quality-adjusted life-year (QALY)) over a lifetime horizon, extrapolated using published data. Analysis was conducted from the perspective of the NHS. Uncertainty in the model was assessed using a range of sensitivity analyses. Results: The study population had a mean age of 68 years, 48% male, with a median inpatient stay of 6 days. Expected life expectancy at discharge was assumed to be 17.74 years. (1) Cost-effectiveness analysis: The automated notification system was more effective (-0.027 reduction in mean events per patient) and provided a cost saving of -£12.17 (-182.07 to 154.80) per patient admission. (2) Cost-utility analysis: Over a lifetime horizon the automated notification system was dominant, demonstrating a positive incremental QALY gain (0.0287 QALYs, equivalent to ~10 days of perfect health) and a cost saving of £55.35. At a threshold of £20,000 per QALY, the probability of automated monitoring being cost-effective in the NHS was 81%. Increased use of cableless sensors may reduce cost-savings, however, the intervention remains cost-effective at 100% usage (ICER: £3,107/QALY). Stratified cost-effectiveness analysis by age, National Early Warning Score (NEWS) on admission, and primary diagnosis indicated the automated notification system was cost-effective for most strategies and that use representative of the patient population studied was the most cost-saving strategy. Conclusion: Automated notification system for adult patients admitted to general wards appears to be a cost-effective use in the NHS; adopting this technology could be good use of scarce resources with significance for patient safety. [ABSTRACT FROM AUTHOR]

It is acknowledged that health technology assessment (HTA) is an inherently value-based activity that makes use of normative reasoning alongside empirical evidence. But the language used to conceptualise and articulate HTA's normative aspects is demonstrably unnuanced, imprecise, and inconsistently employed, undermining transparency and preventing proper scrutiny of the rationales on which decisions are based. This paper – developed through a cross-disciplinary collaboration of 24 researchers with expertise in healthcare priority-setting – seeks to address this problem by offering a clear definition of key terms and distinguishing between the types of normative commitment invoked during HTA, thus providing a novel conceptual framework for the articulation of reasoning. Through application to a hypothetical case, it is illustrated how this framework can operate as a practical tool through which HTA practitioners and policymakers can enhance the transparency and coherence of their decision-making, while enabling others to hold them more easily to account. The framework is offered as a starting point for further discussion amongst those with a desire to enhance the legitimacy and fairness of HTA by facilitating practical public reasoning, in which decisions are made on behalf of the public, in public view, through a chain of reasoning that withstands ethical scrutiny. [ABSTRACT FROM AUTHOR]

The sources of bias in medication adherence research have not been comprehensively explored. We aimed to identify biases expected to affect adherence research and to develop a framework for mapping these onto the phases of adherence (initiation, implementation and discontinuation). A literature search was conducted, key papers were reviewed and a Catalogue of Bias was consulted. The specific biases related to adherence measurement and metrics were mapped onto the phases of adherence using a tabular matrix. Twenty‐three biases were identified, of which 11 were specifically relevant to adherence measures and metrics. The mapping framework showed differences in the numbers and types of biases associated with each measure and metric while highlighting those common to many adherence study designs (e.g., unacceptability bias and apprehension bias). The framework will inform the design of adherence studies and the development of risk of bias tools for adherence research. [ABSTRACT FROM AUTHOR]