Adverse Outcomes of Polypharmacy in Older People : Systematic Review of Reviews

Objective Polypharmacy is widespread among older people, but the adverse outcomes associated with it are unclear. We aim to synthesize current evidence on the adverse health, social, medicines management, and health care utilization outcomes of polypharmacy in older people. Design A systematic review, of systematic reviews and meta-analyses of observational studies, was conducted. Eleven bibliographic databases were searched from 1990 to February 2018. Quality was assessed using AMSTAR (A Measurement Tool to Assess Systematic Reviews). Setting and participants Older people in any health care setting, residential setting, or country. Results Twenty-six reviews reporting on 230 unique studies were included. Almost all reviews operationalized polypharmacy as medication count, and few examined medication classes or disease states within this. Evidence for an association between polypharmacy and many adverse outcomes, including adverse drug events and disability, was conflicting. The most consistent evidence was found for hospitalization and inappropriate prescribing. No research had explored polypharmacy in the very old (aged ≥85 years), or examined the potential social consequences associated with medication use, such as loneliness and isolation. Conclusions and implications The literature examining the adverse outcomes of polypharmacy in older people is complex, extensive, and conflicting. Until polypharmacy is operationalized in a more clinically relevant manner, the adverse outcomes associated with it will not be fully understood. Future studies should work toward this approach in the face of rising multimorbidity and population aging

Journeys to HIV testing and diagnosis among adults aged 50+ years in England : a qualitative interview study

Objectives In England, older adults (aged ≥50 years) are at greater risk of being diagnosed with advanced stage HIV infection than younger adults. We explored journeys to testing and diagnosis among older adults, examining factors associated with late HIV diagnosis in this age group. Methods Semi-structured qualitative interviews were performed with 12 adults diagnosed with HIV at age 50+ years and 12 health care professionals working in sexual health/HIV services. Data were analysed thematically, using the Model of Pathways to Treatment as a framework for analysis. Results Older adults were often found to experience non-linear and complex diagnostic journeys. Pathways to diagnosis were affected by 6 factors: (i) the non-specific nature of HIV symptoms and their misattribution as being age-related; (ii) symptom severity, impact, and visibility; (iii) HIV health literacy; (iv) perceptions of HIV risk; (v) geographical location; and (vi) assessment in non-specialist settings. Conclusions Older adults appear to encounter additional barriers to HIV testing compared with younger people, particularly when they are not part of a group targeted in HIV prevention and testing campaigns. To diagnose HIV more promptly in adults aged 50+ years, HIV knowledge and risk perception must increase in both older people and health care professionals. Health care professionals need to look beyond the ‘high risk’ groups that are most affected by HIV and consider HIV more readily in the diagnostic process. Keywords HIV, older people, HIV testin

National early warning scores in care homes: do policy imperatives reflect a genuine need?

Background the National Early Warning Score (NEWS) is a tool based on vital signs that aims to standardise detection of, and response to, clinical deterioration in adults. NEWS has been adopted in hospitals but not adapted for other settings. This study aimed to explore the feasibility of measuring the NEWS in care homes and describe the distribution of NEWS readings amongst care home residents. Methods descriptive analysis of all NEWS readings recorded in a 30-month period (2016–19) across 46 care homes in one Clinical Commissioning Group in England. Comparisons were made between measurements taken as a routine reading and those prompted by concern about acute illness. Results a total of 19,604 NEWS were recorded from 2,424 older adults (≥65 years; mean age 85). Median NEWS was 2. Two thirds (66%) of residents had a low NEWS (≤2), and 28% had a score of 0. Of the total NEWS readings, 6,277 (32%) were known to be routine readings and 2,256 (12%) were measured because of staff concerns. Median NEWS was 1 for routine and 2 for concern recordings. Overall, only 12% of NEWS were high (≥5), but a higher proportion were elevated when there were concerns about acute illness (18%), compared with routine recordings (7%). Conclusions use of NEWS in care homes appears to be feasible. The majority of NEWS were not elevated, and the distribution of scores is consistent with other out-of-hospital settings. Further work is required to know if NEWS is triggering the most appropriate response and improving care home resident outcomes. Keywords care homes, track and trigger systems, National Early Warning Score, older people Topic internship and residencyprecipitating factorsvital signselderlymedical residenciesnational early warning score (news

Remote and technology-mediated working during the COVID-19 pandemic : A qualitative exploration of the experiences of nurses working in general practice (the GenCo Study)

Aim To explore how nurses working in general practice experienced remote and technology-mediated working during the COVID-19 pandemic. Design Exploratory qualitative study with nursing team members working in general practices in England and national nurse leaders. Methods Data were collected between April and August 2022. Forty participants took part in either semi-structured interviews or focus groups. Data were analysed using Framework Analysis informed by the PERCS (Planning and Evaluating Remote Consultation Services) Framework. University of York ethics approval [HSRGC/2021/458/I] and Health Research Authority approval were obtained [IRAS:30353. Protocol number: R23982. Ref 21/HRA/5132. CPMS: 51834]. The study was funded by The General Nursing Council for England and Wales Trust. Results Participants continued to deliver a significant proportion of patient care in-person. However, remote and technology-mediated care could meet patients' needs and broaden access in some circumstances. When remote and technology-mediated working were used this was often part of a blended model which was expected to continue. This could support some workforce issues, but also increase workload. Participants did not always have access to remote technology and were not involved in decision-making about what was used and how this was implemented. They rarely used video consultations, which were not seen to add value in comparison to telephone consultations. Some participants expressed concern that care had become more transactional than therapeutic and there were potential safety risks. Conclusion The study explored how nurses working in general practice during the COVID-19 pandemic engaged with remote and technology-mediated working. It identifies specific issues of access to technology, workload, hybrid working, disruption to therapeutic relationships, safety risks and lack of involvement in decision-making. Changes were implemented quickly with little strategic input from nurses. There is now an opportunity to reflect and build on what has been learned in relation to remote and technology-mediated working to ensure the future development of safe and effective nursing care in general practice. Impact The paper contributes to understanding of remote and technology-mediated working by nurses working in general practice during the COVID-19 pandemic and indicates to employers and policy makers how this can be supported moving forward. Reporting method Standards for Reporting Qualitative Research (O'Brien et al., 2014). Patient or public contribution This was a workforce study so there was no patient or public contribution. Implications for the profession and patient care The paper highlights specific issues which have implications for the development of remote, technology-mediated and blended working for nurses in general practice, care quality and patient safety. These require full attention to ensure the future development of safe and effective nursing care in general practice moving forward

The well-being of nurses working in general practice during the COVID-19 pandemic : A qualitative study (The GenCo Study)

Aim Exploration of experiences of nurses working in general practice during the COVID-19 pandemic to evaluate the impact on nurses' professional well-being. Design An exploratory qualitative study comprised of case studies of three general practice sites in England and a nationwide interview study of nurses working in general practice and nurse leaders. The study was funded by The General Nursing Council for England and Wales Trust. University of York ethics approval (HSRGC/2021/458/I) and Health Research Authority approval was obtained (IRAS: 30353, Protocol number: R23982, Ref 21/HRA/5132, CPMS: 51834). Methods Forty participants took part. Case site data consisted of interviews/focus groups and national data consisted of semi-structured interviews. Data collection took place between April and August 2022. Analysis was underpinned by West et al.'s (The courage of compassion. Supporting nurses and midwives to deliver high-quality care, The King's fund, 2020) ABC framework of nurses' core work well-being needs. Findings The majority of participants experienced challenges to their professional well-being contributed to by lack of recognition, feeling undervalued and lack of involvement in higher-level decision-making. Some participants displayed burnout and stress. Structural and cultural issues contributed to this and many experiences pre-dated, but were exacerbated by, the COVID-19 pandemic. Conclusions By mapping findings to the ABC framework, we highlight the impact of the COVID-19 pandemic on the well-being of nurses working in general practice and contributing workplace factors. The issues identified have implications for retention and for the future of nursing in general practice. The study highlights how this professional group can be supported in the future. Impact The study contributes to our understanding of the experiences of nurses working in general practice during the COVID-19 pandemic and beyond. Findings have implications for this skilled and experienced workforce, for retention of nurses in general practice, the sustainability of the profession more broadly and care quality and patient safety. Reporting Method Standards for Reporting Qualitative Research (O'Brien et al. in Journal of the Association of American Medical Colleges, 89(9), 1245–1251, 2014). Patient or Public Contribution As this was a workforce study there was no patient or public contribution

Evidence based spinal surgery or the “journal of anecdotal medicine?” Using qualitative interviews with spinal surgeons to understand how the drivers of orthopaedic decision making can influence the creation and adoption of surgical trial evidence

Background: There is uncertainty regarding the best available treatment for stable thoracolumbar fractures without spinal cord injury. We explore what influences surgical decision making for the treatment of stable thoracolumbar fractures in the UK and discuss the implications of variation in spinal surgical work on the creation and adoption of future evidence. Methods: Qualitative semi-structured interviews with 19 spinal surgeons from 13 UK hospitals. Data were collected as part of a mixed methods randomised pilot study (PRESTO). A conceptual framework of drivers of variation in orthopaedic surgical work informed how we analysed and reported our findings. Results: We identified various patient, surgeon, organisational and cultural factors to influence surgical decision making and variation in the treatment of stable thoracolumbar fractures. We then use our findings to present the ‘cycle of uncertainty,’ to illustrate how a lack of evidence is a justification for a Randomised Controlled Trial (RCT) and the reason why a trial is not deemed feasible. Conclusion: Surgical decision-making is complex, particularly in the absence of robust evidence. The reliance on informal sources to inform decision making and the limited role of evidence, have implications for the likelihood that RCT evidence will be created and/or adopted. To break this cycle of uncertainty we suggest focussing earlier in the research cycle to develop context-specific strategies, designed to avoid equipoise from deeming future surgical trials unfeasible and encourage evidence based surgical decision-making. This could include targeted qualitative research conducted prior to RCTs to explore drivers of surgical decision making

Qualitative research to inform hypothesis testing for fidelity-based sub-group analysis in clinical trials : lessons learnt from the process evaluation of a multifaceted podiatry intervention for falls prevention

Background: Ensuring fidelity to complex interventions is a challenge when conducting pragmatic randomised controlled trials. We explore fidelity through a qualitative process evaluation, which was conducted alongside a pragmatic, multicentre, two-arm cohort randomised controlled trial: the REFORM (Reducing Falls with Orthoses and a Multifaceted podiatry intervention) trial. The paper aims, through a qualitative process evaluation, to explore some of the factors that may have affected the delivery of the REFORM intervention and highlight how project-specific fidelity can be assessed using a truly mixed-methods approach when informed by qualitative insights. Design: Semi-structured qualitative interviews carried out as part of a process evaluation. Interviews were analysed thematically. Setting: Seven NHS trusts in the UK and a University podiatry school in Ireland. Interviews were undertaken face-toface or over the telephone. Participants: Twenty-one REFORM trial participants and 14 podiatrists who delivered the REFORM intervention. Results: Factors affecting fidelity included: how similar the intervention was to routine practice; the challenges of delivering a multifaceted intervention to a heterogeneous older population; and practical issues with delivery such as time and training. Trial participants’ views of the intervention, whether falls prevention is a personal priority, their experience of being part of a trial and individual factors such as medical conditions may also have affected intervention fidelity. Conclusions: Our process evaluation highlighted factors that were perceived to have affected the fidelity of the REFORM intervention and in doing so demonstrates the importance of considering fidelity when designing and evaluating pragmatic trials. We propose a number of recommendations of how important project-specific insights from qualitative work can be incorporated into the design of fidelity measurement of future trials, which build on existing conceptual fidelity frameworks. In particular, we encourage adopting a mixed-methods approach whereby qualitative insights can be used to suggest ways to enhance quantitative data collection facilitating integration through hypothesis generation, hypothesis testing and seeking explanation for trial findings. This will provide a framework of enabling measures of fidelity to be incorporated into the understanding of trial results which has been relatively neglected by existing literature. Trial registration: ISRCTN Registry: ISRCTN68240461. Registered on 01/07/2011. Keywords: Process evaluation, Randomised controlled trials, Fidelity, Mixed methods, Falls, Elderly, Ageing, Qualitativ

Identity construction in the very old : A qualitative narrative study

People are living longer internationally, with a growing number experiencing very old age (≥95 years). Physical, psychological and social changes can challenge one’s sense of self and disrupt existing identities. However, experiences of the very old in society are seldom researched and how they construct identity and negotiate a sense of self is little understood. Our study focuses on participants aged >95 years to understand how identity is conceptualised to negotiate a continued place in society. Qualitative interviews with 23 people were thematically analysed, underpinned by Positioning Theory. Five themes were generated: A contented life; reframing independence; familial positioning; appearance and physical wellbeing; reframing ill health. Participants saw themselves as largely content and, despite their world becoming smaller, found pleasure in small routines. Perceptions of self were reframed to maintain autonomy within narrow parameters. Past relationships and experiences/events were drawn on to make sense of ongoing ways of living. There were tensions around feelings of loss of autonomy and independence, with some valuing these over issues such as safety. This sometimes conflicted with views of others and small acts of resistance and subversion were acted out to maintain some sense of control. However, participants minimised progressive ill health. Findings provide insight into how the very old may utilise identity to negotiate, acquiesce, resist and challenge the world around them

Current practice in the measurement and interpretation of intervention adherence in randomised controlled trials : A systematic review

Background Ideally all participants in a randomised controlled trial (RCT) should fully receive their allocated intervention; however, this rarely occurs in practice. Intervention adherence affects Type II error so influences the interpretation of trial results and subsequent implementation. We aimed to describe current practice in the definition, measurement, and reporting of intervention adherence in non-pharmacological RCTs, and how this data is incorporated into a trial's interpretation and conclusions. Methods We conducted a systematic review of phase III RCTs published between January 2018 and June 2020 in the National Institute for Health Research Journals Library for the Health Technology Assessment, Programme Grants for Applied Research, and Public Health Research funding streams. Results Of 237 reports published, 76 met the eligibility criteria and were included. Most RCTs (n = 68, 89.5%) reported adherence, though use of terminology varied widely; nearly three quarters of these (n = 49, 72.1%) conducted a sensitivity analysis. Adherence measures varied between intervention types: behavioural change (n = 10, 43.5%), psychological therapy (n = 5, 83.3%) and physiotherapy/rehabilitation (n = 8, 66.7%) interventions predominately measured adherence based on session attendance. Whereas medical device and surgical interventions (n = 17, 73.9%) primarily record the number of participants receiving the allocated intervention, a third (n = 33, 67.3%) of studies reported a difference in findings between primary and sensitivity analyses. Conclusions Although most trials report elements of adherence, terminology was inconsistent, and there was no systematic approach to its measurement, analyses, interpretation, or reporting. Given the importance of adherence within clinical trials, there is a pressing need for a standardised approach or framework

Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials

Background: Recruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries, or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development ofstrategies to improve recruitment in future research. Design: Two qualitative process evaluations of a United Kingdom-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically. Setting: NHS secondary care organisations throughout the United Kingdom. Interviewswere undertaken via telephone. Participants: 37 health professionals including UK based spinal and orthopaedic surgeons and individuals involved in recruitment to the ACTIVE and PRESTO studies (e.g. research nurses, surgeons, physiotherapists). 22 patients including patients who agreed to participate in the ACTIVE and PRESTO studies (n=15) and patients that declined participation in the ACTIVE study (n=7) were interviewed. Results: We used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient’s circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients’ treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated. Conclusions: A wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials. Trial registries: ACTIVE: (ISRCTN98152560) PRESTO: (ISRCTN12094890