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Background: The DAWN antivirals trial was a multicentric, randomised placebo-controlled trial evaluating antiviral medication for COVID-19 in general practice. The trial was prematurely terminated because of insufficient recruitment. Aim: To explore which factors contributed to the premature termination. Design & setting: General practice in Belgium. Method: Patients were randomised to camostat or placebo (patients and physicians blinded) between June 2021 and July 2022; a third arm evaluating molnupiravir (open label) was opened in March 2022. The outcome assessor was blinded for all comparisons except for the patient reported outcomes in case of molnupiravir. The authors analysed available trial data and evaluated trial context, implementation, and mechanisms of impact based on semi-structured interviews with trial stakeholders. Results: The trial recruited 44 participants; 19 were allocated to camostat (median age 55 years), 8 to molnupiravir (median age 60 years), and 17 to placebo (median age 56 years). There were no serious adverse events in either group. Most difficulties were related to the pandemic context: disruption to routine clinical services; multiple changes to the service model for COVID-19 patients; overwhelmed clinical staff; delays of trial medication; and staff shortages in the sponsor and clinical team. In addition, regulatory approval processes were lengthy and led to additional study procedures. It was felt that the trial started too late, when vaccinations had already begun. Conclusion: The DAWN antivirals trial was stopped prematurely. Although many barriers were related to the pandemic itself, hurdles such as a small and inexperienced sponsor and clinical teams, delays in regulatory processes, and research capacity in routine settings could be overcome by established research infrastructure and standardisation of processes. [ABSTRACT FROM AUTHOR]

Purpose: Geriatric syndromes (GS) are prevalent in the older population, with an impact on morbidity and disability. This study aimed to investigate the prevalence of functional dependence and ten GS in community older adults and to examine the different associations between these syndromes and sociodemographic variables and their impact on functional dependence. Patients and Methods: A cross-sectional study of 342 outpatients seen at the geriatric clinic in the period 2015– 2023. Results: The mean age was 75± 7.4. One-third had functional dependence and 96.2% had at least one GS. The mean number of GS was 3.11± 1.74, ranging from 2.56± 1.67 in the 60s to 3.55± 1.70 in octogenarians. The most common GS found were polypharmacy (79.5%), musculoskeletal pain (49.7%), and Major Neurocognitive Disorder (MND) (32.7%). Polypharmacy was significantly associated with female sex and chronic pain, whereas sensory impairment was associated with male sex. MND, dizziness, and urinary incontinence were the only GS that significantly predicted functional dependence and were typically associated with increasing age. Conclusion: Functional dependence increases as individuals age, paralleled by increases in MND, urinary incontinence, dizziness, sensory impairment, and constipation. Notably, only MND, incontinence, depression, and dizziness were significant predictors of functional dependence. Consequently, it is imperative to screen older adults presenting with these syndromes for early signs of functional decline to optimize their function and avert subsequent dependence, morbidity, and mortality. [ABSTRACT FROM AUTHOR]

Background: Although the importance of context in implementation science is not disputed, knowledge about the actual impact of external context variables on implementation processes remains rather fragmented. Current frameworks, models, and studies merely describe macro-level barriers and facilitators, without acknowledging their dynamic character and how they impact and steer implementation. Including organizational theories in implementation frameworks could be a way of tackling this problem. In this study, we therefore investigate how organizational theories can contribute to our understanding of the ways in which external context variables shape implementation processes. We use the implementation process of goal-oriented primary care in Belgium as a case. Methods: A qualitative study using in-depth semi-structured interviews was conducted with actors from a variety of primary care organizations. Data was collected and analyzed with an iterative approach. We assessed the potential of four organizational theories to enrich our understanding of the impact of external context variables on implementation processes. The organizational theories assessed are as follows: institutional theory, resource dependency theory, network theory, and contingency theory. Data analysis was based on a combination of inductive and deductive thematic analysis techniques using NVivo 12. Results: Institutional theory helps to understand mechanisms that steer and facilitate the implementation of goal-oriented care through regulatory and policy measures. For example, the Flemish government issued policy for facilitating more integrated, person-centered care by means of newly created institutions, incentives, expectations, and other regulatory factors. The three other organizational theories describe both counteracting or reinforcing mechanisms. The financial system hampers interprofessional collaboration, which is key for GOC. Networks between primary care providers and health and/or social care organizations on the one hand facilitate GOC, while on the other hand, technology to support interprofessional collaboration is lacking. Contingent variables such as the aging population and increasing workload and complexity within primary care create circumstances in which GOC is presented as a possible answer. Conclusions: Insights and propositions that derive from organizational theories can be utilized to expand our knowledge on how external context variables affect implementation processes. These insights can be combined with or integrated into existing implementation frameworks and models to increase their explanatory power. [ABSTRACT FROM AUTHOR]

Aims: To increase our understanding of which factors contribute to long‐term benzodiazepine receptor agonist (BZRA) use for insomnia in primary care, from a patients', general practitioners' (GP) and pharmacists' perspective. Design: Qualitative research following a grounded theory approach. Setting: Primary care in Belgium. Participants: Twenty‐four participants were interviewed, including nine patients, six GPs and nine pharmacists. Measurements: In‐depth, semistructured interviews with iterative cycles of data collection and analysis. Transcripts were analysed using the framework method. Thematic findings were interpreted in the context of the Theoretical Domains Framework. Findings: A reflexive relation was identified between views about hypnotic use at the level of society, healthcare and patients. Behaviour change appeared to depend strongly on context and social influence, including a need for supporting relationships by all stakeholders. Six key messages captured factors that contribute to long‐term BZRA use for insomnia in primary care: societal beliefs as a game changer, the opportunity of nonpharmacological treatment, collaborative primary care, patient‐centred goals, informed consent and self‐management. Conclusions: Long‐term BZRA use for insomnia is a complex and multifaceted public health problem that is not adequately addressed in primary care at this time. Although primary care professionals in this study found discontinuation of long‐term BZRA use relevant to the patient's health, many organisational and personal barriers were reported. Moreover, the current social and healthcare context is not empowering patients and professionals to reduce long‐term BZRA use for insomnia. Specifically, for primary care, all stakeholders reported the need for a nonmedicalised relationship between the patient and GP to lower prescribing rates. Patient or Public Contribution: The Flemish Patient Platform, a patient representative organisation, assisted with recruitment by launching a call for participants in their newsletter and volunteered to disseminate the results. The call for recruitment was also published online in social media groups regarding insomnia and via posters in public pharmacies. Patients or public were not involved in designing or conducting the interview study. [ABSTRACT FROM AUTHOR]