Understanding stakeholder views regarding the design of an intervention trial to reduce anticholinergic burden : a qualitative study

Funding statement This research was supported by the Chief Scientist Office under their Catalytic Research Grants Scheme, CSO reference number: CGA/18/47. Acknowledgments We gratefully acknowledge the support from the Alliance, the Glasgow Stroke Group and NKS in recruiting focus group participants and conducting the focus groups and Scottish Primary Care Research Network for recruiting patients from primary care. Special thanks to Irene Oldfather from Alliance and Naseem Suleman from NKS for their help in setting up interviews and focus groups. We gratefully acknowledge the research participants who provided their views and insights.Peer reviewedPublisher PD

Barriers and facilitators to reducing anticholinergic burden: a qualitative systematic review

Background: Despite common use, anticholinergic medications have been associated with serious health risks. Interventions to reduce their use are being developed and there is a need to understand their implementation into clinical care. Aim of review: This systematic review aims to identify and analyse qualitative research studies exploring the barriers and facilitators to reducing anticholinergic burden. Methods: Medline (OVID), EMBASE (OVID), CINAHL (EMBSCO) and PsycINFO (OVID) were searched using comprehensive search terms. Peer reviewed studies published in English presenting qualitative research in relation to the barriers and facilitators of deprescribing anticholinergic medications, involving patients, carers or health professionals were eligible. Normalization Process Theory was used to explore and explain the data. Results: Of 1764 identified studies, two were eligible and both involved healthcare professionals (23 general practitioners, 13 specialist clinicians and 12 pharmacists). No studies were identified that involved patients or carers. Barriers to collaborative working often resulted in poor motivation to reduce anticholinergic use. Low confidence, system resources and organisation of care also hindered anticholinergic burden reduction. Good communication and relationships with patients, carers and other healthcare professionals were reported as important for successful anticholinergic burden reduction. Having a named person for prescribing decisions, and clear role boundaries, were also important facilitators. Conclusions: This review identified important barriers and facilitators to anticholinergic burden reduction from healthcare provider perspectives which can inform implementation of such deprescribing interventions. Studies exploring patient and carer perspectives are presently absent but are required to ensure person-centeredness and feasibility of future interventions

Barriers and facilitators to reducing anticholinergic burden from the perspectives of patients, their carers, and healthcare professionals: A protocol for qualitative evidence synthesis

Anticholinergic drugs are prescribed for a range of conditions including gastrointestinal disorders, overactive bladder, allergies, and depression. While in some circumstances anticholinergic effects are therapeutic, they also pose many undesired or adverse effects. The overall impact from concomitant use of multiple medications with anticholinergic properties is termed “anticholinergic burden” (ACB). Greater ACB is associated with increased risks of impaired physical and cognitive function, falls, cardiovascular events and mortality. This has led to the development of interventions aimed at reducing ACB through the deprescribing of anticholinergic drugs. However, little is known about the implementation issues that may influence successful embedding and integration of such interventions into routine clinical practice. In this paper we present the protocol for our systematic review that aims to identify the qualitative evidence for the barriers and facilitators to reducing ACB from the perspectives of patients, carers and healthcare professionals. A comprehensive search strategy will be conducted across OVID Medline, EMBASE, PsycInfo and CINAHL. The review will be conducted in accordance with ENTREQ (Enhancing Transparency in Reporting the Synthesis of Qualitative Research) and has been registered with PROSPERO (Registration CRD42018109084). Normalization Process Theory (NPT) will be used to explore, understand and explain qualitative data in relation to factors that act as barriers or facilitators to ACB reduction

‘Mind the Gap’ : extending outcome measurement for accountability and meaningful innovation

We examine the outcome measurement landscape in care leaver innovation, where many innovations to support transitions of young people leaving care fail to sustain beyond a fixed-term pilot, and fewer impact wider transition policies. Our empirical qualitative study comprises interviews with 31 senior UK children’s social care policy and practice professionals, 103 interviews across five innovation-focused case studies within England with a range of public and private providers. We consider these data in relation to evaluations from a nationally diffused social care innovation. We identified three measurement landscape challenges. First, we highlight the limits of the economically oriented measurement and identify an overlooked outcome measurement demand. Second, we emphasise a need to stratify care leaver population outcomes to better reflect individuals transition through different domains of life and trajectory. Third, we identify areas of precarity around the intended use of care leaver experience. We conclude that tensions exist between the pull towards a unified approach to outcome measurement and the reality of decoupled outcome requirements and legitimacy-seeking priorities which differ according to stakeholder. These tensions entrench stagnant innovation. Recognition of roles and legitimacies that exist across the process of care leaver innovation is warranted. Opportunities for action are discussed

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

Lockjaw from a metastatic uterine leiomyosarcoma- case report and review of the literature

Abstract Background Leiomyosarcoma (LMS) is a malignant tumour formed of cells with distinct smooth muscle features. Leiomyosarcomas rarely metastasise to the oral cavity and this literature review details all reported cases of metastasis to the mandible found in the literature. This offers a unique perspective by specifying mandible as the site of metastasis of leiomyosarcoma. Case presentation A 53-year-old female presented to her General Practitioner (GP) with heavy menstrual bleeding and was diagnosed with multiple fibroids. Folowing a hysterectomy and removal of both tubes and ovaries for these symptomatic uterine fibroids, an incidental diagnosis of low grade leiomyosarcoma was made. A CT scan found no evidence of residual or metastatic disease and no further treatment was deemed necessary. 6 months later she presented to A & E with a numb lower lip but it took another 6 months for the diagnosis of metastatic LMS to the mandible to be made. Discussion Leiomyosarcomas are aggressive tumours which are liable to metastasise and therefore have a poor prognosis. An extensive literature review was undertaken to explore the frequency of metastasis in the maxillo-facial region. Conclusions Although metastasis to the oral region is very rare as suggested from the literature review, when patients present with unusual symptoms after a diagnosis of LMS, physicians should be aware of the possibility of LMS metastases

An inter-disciplinary perspective on evaluation of innovation to support care leavers’ transition

Purpose Young people who are looked after by the state face challenges as they make the transition from care to adulthood, with variation in support available. In the past decade, funding has been directed towards organisations to pilot innovations to support transition, with accompanying evaluations often conducted with a single disciplinary focus, in a context of short timescales and small budgets. Recognising the value and weight of the challenge involved in evaluation of innovations that aim to support the transitions of young people leaving care, this paper aims to provide a review of evaluation approaches and suggestions regarding how these might be developed. Design/methodology/approach As part of a wider research programme to improve understanding of the innovation process for young people leaving care, the authors conducted a scoping review of grey literature (publications which are not peer reviewed) focusing on evaluation of innovations in the UK over the past 10 years. The authors critiqued the evaluation approaches in each of the 22 reports they identified with an inter-disciplinary perspective, representing social care, public health and organisation science. Findings The authors identified challenges and opportunities for the development of evaluation approaches in three areas. Firstly, informed by social care, the authors suggest increased priority should be granted to participatory approaches to evaluation, within which involvement of young people leaving care should be central. Secondly, drawing on public health, there is potential for developing a common outcomes’ framework, including methods of data collection, analysis and reporting, which aid comparative analysis. Thirdly, application of theoretical frameworks from organisation science regarding the process of innovation can drive transferable lessons from local innovations to aid its spread. Originality/value By adopting the unique perspective of their multiple positions, the authors’ goal is to contribute to the development of evaluation approaches. Further, the authors hope to help identify innovations that work, enhance their spread, leverage resources and influence policy to support care leavers in their transitions to adulthood