Mapping review of 'proof-of-concept in mental health implementation research using the TRL framework: a need for a better focus and conceptual clarification

Background
Proof-of-concept (PoC) development is a key step in implementation sciences. However, there is a dearth of studies in this area and the use of this term in health and social sciences is ambiguous.

Objective
The objective was to remove the ambiguity surrounding the PoC and pilot study stage in the research development process using a standard system to rate the development of projects and applications provided by the Technology Readiness Levels (TRL) framework.

Design
Mapping review and critical analysis using TRL as the standard measure.

Search strategy and charting method
PubMed and PsycInfo databases were searched for papers that reported PoC studies of mental health interventions up to August 2023. Data were extracted, described and tabulated.

Eligibility criteria
Included were PoC studies in mental health implementation research. Exclusion criteria were research relating to biomedical (drugs) development, neurocognitive tools, neuropsychology, medical devices, literature reviews or discussion papers or that did not include the term ‘proof-of-concept’ in the title, abstract or text.

Results
From the 83 citations generated from the database search, 22 studies were included in this mapping review. Based on the study title, abstract and text, studies were categorised by research development stage according to the TRL framework. This review showed 95% of the studies used PoC incorrectly to describe the development stage of their research but which were not at this specific level of project development.

Conclusions
The TRL was a useful reference framework to improve terminological clarity around the term ‘proof-of-concept’ in implementation research. To extend the use of TRL in implementation sciences, this framework has now been adapted and validated to a health and social science-related research context accompanied by a health-related glossary of research process terms and definitions to promote a common vocabulary and shared understanding in implementation sciences.

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Agosto 2024

International Initiatives of the American Heart Association: Original Concepts, Present Programs, and Future Focus: A Science Advisory From the American Heart Association

Circulation, Ahead of Print. The American Heart Association (AHA), founded in 1924, is anchored in the core belief that scientific research can lead the way to better prevention, treatment, recovery, and ultimately a cure for cardiovascular disease. Historically, the association’s involvement in international efforts centered on scientific cooperation. Activities mostly involved AHA leadership presenting at international scientific meetings and leaders from other countries sharing scientific and medical information at AHA meetings. Although the AHA’s and American Stroke Association’s international efforts have expanded substantially since those early days, global knowledge exchange remains the bedrock of its international endeavors. As the AHA turns 100, we reflect on the successful global efforts in prevention, resuscitation, global advocacy, quality improvement, and health equity that have guided the organization to a place of readiness for “advancing health and hope, for everyone, everywhere.” Motivated by the enormous potential for population health gains in an aging world, the AHA is entering its second century with redoubled commitment to improving global cardiovascular and cerebrovascular health for all.

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Agosto 2024

Womens health in focus: Real-world data on valproate prescriptions during pregnancy – a cohort study in Catalonia (Spain)

Objectives
To characterise the exposure to valproate within a cohort of pregnant women using electronic health records (EHRs) from Catalonia (System for the Development of Research in Primary Care, SIDIAP).

Design
Drug-utilisation cohort study covering the period from January 2011 to June 2020. The study included pregnancy episodes of women from Catalonia identified by the algorithm.

Setting
Data were sourced from SIDIAP, a comprehensive EHR repository that includes information from various data sources: recorded prescriptions (both hospital and primary care), diagnoses and sociodemographic characteristics identified by primary care physicians, and sexual and reproductive health data from ASSIR (used by gynaecologists and midwives).

Participants
Women aged 12–50 with at least one pregnancy episode occurred during January 2011–June 2020 and at least a prescription of valproate during pregnancy.

Primary and secondary outcomes
Primary outcomes included valproate exposure, measured through prevalence and cumulative incidence in pregnancy episodes and by trimester. The impact of regulatory measures (risk mitigation measures, RMMs) was assessed, and prescriptions over time were analysed using interrupted time series analysis. Secondary outcomes included health issues, pregnancy outcomes, smoking habits and socioeconomic characteristics.

Results
A total of 99 605 pregnancies were identified, with at least 3.03 (95% CI 2.69 to 3.39) exposed to valproate at some point (302 pregnancies, 276 women). The median pregnancy duration was 38.30 weeks (IQR 12.6–40.1), and the median age at pregnancy was 32.37 years (IQR 27.20–36.56). Epilepsy was the most frequent health issue. The prevalence and cumulative incidence of valproate prescriptions decreased during pregnancy and increased postpregnancy. The RMMs implemented in 2014 led to a reduction in monthly valproate prescriptions during pregnancy in this cohort.

Conclusions
The study highlights the decline in valproate prescriptions during pregnancy due to RMMs and underscores the need for standardised methodologies in future studies to ensure the safety of pregnant patients and optimise scientific evidence.

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Agosto 2024

Time for a Focus on Cessation of E-Cigarettes

E-cigarettes, which were introduced in the US market in 2007, have experienced tremendous growth in the US and globally and are the focus of an intense and often controversial public health debate concerning harms and benefits. The most important potential benefit of e-cigarettes is to assist with cigarette smoking cessation and reduce exposure to cigarette-related harm among those who completely switch to e-cigarettes. However, e-cigarettes can also produce harm and serve to initiate and maintain nicotine addiction in populations for whom there is no potential public health benefit of use. Indeed, e-cigarette use prevalence is highest and rising among youth and young adults, many of whom have never smoked cigarettes. Among cigarette smokers, dual use of e-cigarettes and cigarettes is common, and many who had successfully quit smoking in the past are reinitiating nicotine use with e-cigarettes. Many youth and adults who use e-cigarettes experience nicotine addiction and physical dependence and are keen to quit e-cigarettes. However, in the national and worldwide discourse about the public health benefits vs harm of e-cigarettes there has been minimal focus on how to support individuals who want to stop using e-cigarettes, leading to a critical lack of evidence-based treatments.

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Agosto 2024

Views and opinions of patients with glaucoma and age-related macular degeneration on vision home-monitoring: a UK-based focus group study

Objective
To investigate the views, hopes and concerns of patients living with glaucoma and age-related macular degeneration (AMD) regarding vision home-monitoring.

Design
Qualitative study using focus groups and questionnaires. Participants were given three disease-relevant home-monitoring tests to try. The tests consisted of three visual field tests for the glaucoma groups (Melbourne Rapid Fields, Eyecatcher, Visual Fields Fast) and three acuity and/or contrast-sensitivity tests for AMD groups (Alleye, PopCSF, SpotChecks). Focus group data were thematically analysed.

Setting
University meeting rooms in London, UK.

Participants
Eight people with glaucoma (five women, median age 74) and seven people with AMD (four women, median age 77) volunteered through two UK-based charities. Participants were excluded if they did not self-report a diagnosis of glaucoma or AMD or if they lived further than a 1-hour travel distance from the university (to ensure minimal travel burden on participants).

Results
Six themes emerged from focus groups, the two most frequently referenced being: ‘concerns about home-monitoring’ and ‘patient and practitioner access to results’. Overall, participants believed home-monitoring could provide patients with a greater sense of control, but also expressed concerns, including: the possibility of home-monitoring replacing face-to-face appointments; the burden placed on clinicians by the need to process additional data; struggles to keep up with requisite technologies; and potential anxiety from seeing worrying results. Most devices were scored highly for usability, though several practical improvements were suggested.

Conclusion
Patients with mild-to-moderate glaucoma/AMD expect vision home-monitoring to be beneficial, but have significant concerns about its potential implementation.

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Luglio 2024