Older People with Frailty Publications

Research papers published by our team

2022

Rennie, K. et al (2022) PREVENT: metformin to improve physical performance in older people with sarcopenia and physical prefrailty/frailty - protocol for a double-blind, randomised controlled proof-of-concept trial.

Authors - Katherine J Rennie, Miles Witham, Penny Bradley, Andrew Clegg, Stephen Connolly, Helen C Hancock, Shaun Hiu, Leanne Marsay, Claire McDonald, Laura Robertson, Laura Simms, Unit, Alison J Steel, Claire J Steves, Bryony Storey, James Wason, Nina Wilson, Thomas von Zglinicki, Avan A P Sayer.

https://bmjopen.bmj.com/content/12/7/e061823

Abstract

Introduction

Skeletal muscle dysfunction is central to both sarcopenia and physical frailty, which are associated with a wide range of adverse outcomes including falls and fractures, longer hospital stays, dependency and the need for care. Resistance training may prevent and treat sarcopenia and physical frailty, but not everyone can or wants to exercise. Finding alternatives is critical to alleviate the burden of adverse outcomes associated with sarcopenia and physical frailty. This trial will provide proof-of-concept evidence as to whether metformin can improve physical performance in older people with sarcopenia and physical prefrailty or frailty.

Methods and analysis

MET-PREVENT is a parallel group, double-blind, placebo-controlled proof-of-concept trial. Trial participants can participate from their own homes, including completing informed consent and screening assessments. Eligible participants with low grip strength or prolonged sit-to-stand time together with slow walk speed will be randomised to either oral metformin hydrochloride 500 mg tablets or matched placebo, taken three times a day for 4 months. The recruitment target is 80 participants from two secondary care hospitals in Newcastle and Gateshead, UK. Local primary care practices will act as participant identification centres. Randomisation will be performed using a web-based minimisation system with a random element, balancing on sex and baseline walk speed. Participants will be followed up for 4 months post-randomisation, with outcomes collected at baseline and 4 months. The primary outcome measure is the four metre walk speed at the 4-month follow-up visit.

Ethics and dissemination

The trial has been approved by the Liverpool NHS Research Ethics Committee (20/NW/0470), the Medicines and Healthcare Regulatory Authority (EudraCT 2020-004023-16) and the UK Health Research Authority (IRAS 275219). Results will be made available to participants, their families, patients with sarcopenia, the public, regional and national clinical teams, and the international scientific community.

DOI: https://doi.org/10.1136%2Fbmjopen-2022-061823

Frost, R. et al (2022) Clinical and cost-effectiveness of a personalised health promotion intervention enabling independence in older people with mild frailty (‘HomeHealth’) compared to treatment as usual: study protocol for a randomised controlled trial.

Authors - Rachael Frost, Christina Avgerinou, Claire Goodman, Andrew Clegg, Jane Hopkins, Rebecca L. Gould, Benjamin Gardner, Louise Marston, Rachael Hunter, Jill Manthorpe, Claudia Cooper, Dawn A. Skelton, Vari M. Drennan, Pip Logan, Kate Walters.

https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-022-03160-x

Abstract

Background

Frailty is clinically associated with multiple adverse outcomes, including reduced quality of life and functioning, falls, hospitalisations, moves to long-term care and mortality. Health services commonly focus on the frailest, with highest levels of need. However, evidence suggests that frailty is likely to be more reversible in people who are less frail. Evidence is emerging on what interventions may help prevent or reduce frailty, such as resistance exercises and multi-component interventions, but few interventions are based on behaviour change theory. There is little evidence of cost-effectiveness.

Previously, we co-designed a new behaviour change health promotion intervention (“HomeHealth”) to support people with mild frailty. HomeHealth is delivered by trained voluntary sector support workers over six months who support older people to work on self-identified goals to maintain their independence, such as strength and balance exercises, nutrition, mood and enhancing social engagement. The service was well received in our feasibility randomised controlled trial and showed promising effects upon outcomes.

Aim

To test the clinical and cost-effectiveness of the HomeHealth intervention on maintaining independence in older people with mild frailty in comparison to treatment as usual (TAU).

Methods

Single-blind individually randomised controlled trial comparing the HomeHealth intervention to TAU. We will recruit 386 participants from general practices and the community across three English regions. Participants are included if they are community-dwelling, aged 65 + , with mild frailty according to the Clinical Frailty Scale. Participants will be randomised 1:1 to receive HomeHealth or TAU for 6 months. The primary outcome is independence in activities of daily living (modified Barthel Index) at 12 months. Secondary outcomes include instrumental activities of daily living, quality of life, frailty, wellbeing, psychological distress, loneliness, cognition, capability, falls, carer burden, service use, costs and mortality. Outcomes will be analysed using linear mixed models, controlling for baseline Barthel score and site. A health economic analysis and embedded mixed-methods process evaluation will be conducted.

Discussion

This trial will provide definitive evidence on the effectiveness and cost-effectiveness of a home-based, individualised intervention to maintain independence in older people with mild frailty in comparison to TAU, that could be implemented at scale if effective.

DOI: https://doi.org/10.1186/s12877-022-03160-x

Brundle, C. et al (2022) Eligibility screening older research participants using remote cognitive assessment — experiences and reflections from a primary care randomised controlled trial.

Authors - Caroline Brundle, Anne Heaven, Andrew Clegg.

https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06805-9

Abstract

Background

The COVID-19 pandemic forced many research teams to adjust the way they conduct studies, including moving to remote delivery of some or all of their recruitment and data collection processes. The Montreal Cognitive Assessment (MoCA) is widely used in research and is available in multiple formats for different groups and assessment settings. Here, we reflect on our experiences of administering the MoCA Blind/Telephone as part of the initial telephone eligibility check for participation in a randomised controlled trial with community-dwelling older people with frailty.

Main body

In response to COVID-19, a number of changes were made to the trial’s screening and recruitment procedures, to minimise the amount of time the researchers would spend in the participants’ homes when recruitment began in May 2021. One of the changes was for the researchers to conduct a cognitive assessment for eligibility during an initial telephone call, rather than during the subsequent home visit for consent and baseline data collection. We found that in comparison with conducting the assessment in-person, telephone administration caused uncertainty for the researchers about whether participants were struggling to answer questions due to cognition or hearing impairment. Some participants experienced practical difficulties when combining holding a telephone and completing one of the assessment items. It was hard for the researchers to judge the emotional impact that undertaking the assessment was having on the older people on the telephone, without visual warning signs of fatigue or mood. We discuss the potential impact of these issues on trial recruitment and participant engagement, and the feasibility of videoconferencing as an alternative method of conducting the MoCA.

Conclusion

The MoCA is a useful tool when cognitive impairment is part of screening and data collection and it is helpful to have the option to use the test remotely. However, as we have found, telephone testing is not always straightforward. Researchers should weigh up the pros and cons for each individual study, especially those involving older adults. If choosing remote methods, consider the practicality of using videoconferencing and think about the possible impact of telephone assessment on the relationship with the (potential) research participants.

DOI: https://doi.org/10.1186/s13063-022-06805-9

Smith, H. et al (2022) Reducing delayed transfer of care in older people: A qualitative study of barriers and facilitators to shorter hospital stays.

Authors - Helen Smith, Chloe Grindey, Isabel Hague, Louise Newbould, Lesley Brown, Andrew Clegg, Carl Thompson, Rebecca Lawton.

https://onlinelibrary.wiley.com/doi/10.1111/hex.13588

Abstract

Introduction

Growing numbers of older patients occupy hospital beds despite being ‘medically fit’ for discharge. These Delayed Transfers of Care amplify inefficiencies in care and can cause harm. Delayed transfer because of family or patient choice is common; yet, research on patient and family perspectives is scarce. To identify barriers to, and facilitators of, shorter hospital stays, we sought to understand older people's and caregivers' thoughts and feelings about the benefits and harms of being in hospital and the decisions made at discharge.

Methods

A multimethod qualitative study was carried out. Content analysis was carried out of older people's experiences of health or care services submitted to the Care Opinion online website, followed by telephone and video interviews with older people and family members of older people experiencing a hospital stay in the previous 12 months.

Results

Online accounts provide insight into how care was organized for older people in the hospital, including deficiencies in care organization, the discharge process and communication, as well as how care was experienced by older people and family members. Interview-generated themes included shared meanings of hospitalization and discharge experiences and the context of discharge decisions including failure in communication systems, unwarranted variation and lack of confidence in care and lack of preparation for ongoing care.

Conclusion

Poor quality and availability of information, and poor communication, inhibit effective transfer of care. Communication is fundamental to patient-centred care and even more important in discharge models characterized by limited assessments and quicker discharge. Interventions at the service level and targeted patient information about what to expect in discharge assessments and after discharge could help to address poor communication and support for improving discharge of older people from hospital.

Patient or Public Contribution

The Frailty Oversight Group, a small group of older people providing oversight of the Community Aging Research 75+ study, provided feedback on the research topic and level of interest, the draft data collection tools and the feasibility of collecting data with older people during the COVID-19 pandemic. The group also reviewed preliminary findings and provided feedback on our interpretation.

DOI: https://doi.org/10.1111/hex.13588

Authors - Nicky Kime, Alan Wright, Anne Heaven, Rebecca Hawkins, Jane Smith, Bonnie Cundill, Robbie Foy, Rebecca Lawton, Amanda Farrin, Claire Hulme & Andrew Clegg.

https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-022-03426-4

Abstract

Background

Personalised Care Planning (PCP) is a collaborative approach used in the management of chronic conditions. Core components of PCP are shared decision making to achieve joint goal setting and action planning by the clinician and patient. We undertook a process evaluation within the PROSPER feasibility trial to understand how best to implement PCP for older people with frailty in the community.

Methods

The trial was set in two localities in England. We observed training sessions and intervention delivery at three time points during the 12-week intervention period. We interviewed delivery teams before, during and after the intervention period, as well as primary care staff. We interviewed older people who had received, declined or withdrawn from PCP. We explored training of staff delivering PCP, structures, mechanisms and resources needed for delivery, and influences on uptake. We undertook a framework approach to data analysis.

Findings

We observed thirteen training sessions and interviewed seven delivery staff, five primary care staff, and twenty older people, including seven who had declined or withdrawn from the intervention. Delivery teams successfully acquired skills and knowledge, but felt underprepared for working with people with lower levels of frailty. Timing of training was critical and ‘top-ups’ were needed. Engagement with primary care staff was tenuous. Older people with lower frailty were unclear of the intervention purpose and benefits, goal setting and action planning.

Conclusions

PCP has the potential to address the individualised needs of older people with frailty. However, training requires careful tailoring and is ideally on-going. Considerable efforts are required to integrate statutory and voluntary stakeholders, understanding the expectations and contributions of each agency from the outset. In addition, older people with frailty need time and support to adjust to new ways of thinking about their own health now and in the future so they can participate in shared decision making. These key factors will be essential when developing models of care for delivering PCP to support older people with frailty to sustain their independence and quality of life.

DOI: https://doi.org/10.1186/s12877-022-03426-4

Authors - Kate Gridley, Kate Baxter, Yvonne Birks, Louise Newbould, Stephen Allan, Daniel Roland, Gintare Malisauskaite, Karen Jones

https://onlinelibrary.wiley.com/doi/10.1111/hsc.13911

Abstract

Unnecessarily prolonged stays in hospitals can have negative impacts on patients and present avoidable costs to health and social care systems. This paper presents the qualitative findings of a multi-methods study of the social care causes of delayed transfers of care (DTOC) for older people in England. The quantitative strand of this study found that DTOC are significantly affected by homecare supply. In this paper, we explore in depth how and why social care capacity factors lead to delays, from the perspectives of those working within the system. We examined the local transfer arrangements in six English local authority (LA) sites that were purposively sampled to include a range of DTOC performance and LA characteristics. Between March and December 2018, 52 professionals involved in arranging or facilitating discharge from hospitals in these sites provided qualitative data, primarily through semi-structured interviews. Topics included discharge teams and processes, strategic issues and perceived causes of delays. The thematic analysis uncovered the nuances behind the causes of DTOC previously categorised broadly as ‘provider capacity’ and ‘patient choice’. In particular, our analysis highlights the lack of fit between available provision and the needs of people leaving hospital (theme 1); workforce inconsistencies (theme 2) and a myth of patient choice (theme 3). We are now at a turning point in the development of policy to reduce DTOC in the English system, with the full implications of a new national discharge to assess programme yet to be seen. Our research shows the significance of the alignment of service capacity, including the type and location of provision, with the needs and preferences of those leaving hospital. As the new system becomes established, attendance to such nuances behind blockages in the system will be more important than ever.

DOI: https://doi.org/10.1111/hsc.13911

Authors - Emily Heavey, Kate Baxter, Yvonne Birks

https://www.cambridge.org/core/journals/ageing-and-society/article/care-chronicles-needing-seeking-and-getting-selffunded-social-care-as-biographical-disruptions-among-older-people-and-their-families/320DC7B49844284B6CA87A73AE9F03DA

Abstract

Social care to assist with the activities of daily living is a necessity for many older people; while informal care provided by family members can be a first step to meeting care needs, formal care provided by professionals is often needed or preferred by older people and their families. In England, the number of older people paying for formal care is set to rise, driven by an ageing population and the limited resources of local authorities. Little is known about how older people and their families experience the potentially disruptive processes of deciding upon, searching for and implementing such care, including the financial implications. This paper explores accounts of seeking self-funded social care in England, told by older people and their families in 39 qualitative interviews. These accounts, which we call ‘care chronicles’, include stories about the emergence of care needs and informal care-giving, the search for formal care, including interacting with new systems and agencies, and getting formal (paid) care, either as the recipient or an involved family member. Stories are analysed through the lens of biographical disruption, and analysis demonstrates that such disruptions can occur for older people and their families across the entirety of the care chronicle. Needing, seeking and getting care all have the potential to cause practical and symbolic disruptions; moreover, these disruptions can be cumulative and cyclical, as attempts to resolve or minimise one disruption can lead to new ones. While the concept of biographical disruption is a mainstay in medical sociology, it is less frequently applied to issues relating to social care, and most often takes embodiment as a key focus. This study is novel in its application of the concept to experiences of seeking self-funded care, and in its introduction of the concept of ‘care chronicles’, which invite a longer and broader view of biographical disruptions in the lives of older people with care needs and their families.

DOI: https://doi.org/10.1017/S0144686X22000599

Authors - Andrew Clegg, Karen Bandeen-Roche, Amanda Farrin, Anne Forster, Thomas M Gill, John Gladman, Ngaire Kerse, Richard Lindley, Richard J McManus, Rene Melis, Ruben Mujica-Mota, Parminder Raina, Kenneth Rockwood, Ruth Teh, Danielle van der Windt, Miles Witham.

https://academic.oup.com/ageing/article/51/4/afac090/6572255

Abstract

Evidence-based decisions on clinical and cost-effectiveness of interventions are ideally informed by meta-analyses of intervention trial data. However, when undertaken, such meta-analyses in ageing research have typically been conducted using standard methods whereby summary (aggregate) data are extracted from published trial reports. Although meta-analysis of aggregate data can provide useful insights into the average effect of interventions within a selected trial population, it has limitations regarding robust conclusions on which subgroups of people stand to gain the greatest benefit from an intervention or are at risk of experiencing harm. Future evidence synthesis using individual participant data from ageing research trials for meta-analysis could transform understanding of the effectiveness of interventions for older people, supporting evidence-based and sustainable commissioning. A major advantage of individual participant data meta-analysis (IPDMA) is that it enables examination of characteristics that predict treatment effects, such as frailty, disability, cognitive impairment, ethnicity, gender and other wider determinants of health. Key challenges of IPDMA relate to the complexity and resources needed for obtaining, managing and preparing datasets, requiring a meticulous approach involving experienced researchers, frequently with expertise in designing and analysing clinical trials. In anticipation of future IPDMA work in ageing research, we are establishing an international Ageing Research Trialists collective, to bring together trialists with a common focus on transforming care for older people as a shared ambition across nations.

DOI: https://doi.org/10.1093/ageing/afac090

Authors - Chris Wilkinson, Jianhua Wu, Andrew Clegg, Ramesh Nadarajah, Kenneth Rockwood, Oliver Todd, Chris P Gale.

https://academic.oup.com/europace/article/24/7/1065/6542528

Abstract

Aims

People with atrial fibrillation (AF) frequently live with frailty, which increases the risk of mortality and stroke. This study reports the association between oral anticoagulation (OAC) and outcomes for people with frailty, and whether there is overall net benefit from treatment in people with AF.

Methods and results

Retrospective open cohort electronic records study. Frailty was identified using the electronic frailty index. Primary care electronic health records of 89 996 adults with AF and CHA2DS2-Vasc score of ≥2 were linked with secondary care and mortality data in the Clinical Practice Research Database (CPRD) from 1 January 1998 to 30 November 2018. The primary outcome was a composite of death, stroke, systemic embolism, or major bleeding. Secondary outcomes were stroke, major bleeding, all-cause mortality, transient ischaemic attack, and falls. Of 89 996 participants, 71 256 (79.2%) were living with frailty. The prescription of OAC increased with degree of frailty. For patients not prescribed OAC, rates of the primary outcome increased alongside frailty category. Prescription of OAC was associated with a reduction in the primary outcome for each frailty category [adjusted hazard ratio, 95% confidence interval, no OAC as reference; fit: vitamin K antagonist (VKA) 0.69, 0.64–0.75, direct oral anticoagulant (DOAC) 0.42, 0.33–0.53; mild frailty: VKA 0.52, 0.50–0.54, DOAC 0.57, 0.52–0.63; moderate: VKA 0.54, 0.52–0.56, DOAC 0.57, 0.52–0.63; severe: VKA 0.48, 0.45–0.51, DOAC 0.58, 0.52–0.65], with cumulative incidence function effects greater for DOAC than VKA.

Conclusion

Frailty among people with AF is common. The OAC was associated with a reduction in the primary endpoint across all degrees of frailty.

DOI: https://doi.org/10.1136/bmjopen-2021-054568

Authors - Gintare Malisauskaite, Karen Jones, Stephen Allan, Daniel Roland, Yvonne Birks, Kate Baxter, Kate Gridley.

https://bmjopen.bmj.com/content/12/2/e054568

Abstract

Objectives Patients should be discharged from hospital when they are medically fit. However, discharges are often delayed for non-medical reasons including access to social care. One aim of local health and social care partnerships to improve urgent and emergency care in England (known as urgent and emergency care (UEC) vanguards) was to improve integration of health and social care, which could lead to fewer delays. Consequently, we aimed to assess the impact of UEC vanguards on delayed discharges from hospital (delayed transfers of care (DTOC)) in England.

Design

Using a synthetic control estimation method 29 local authorities (LAs) that were UEC vanguards partners were averaged into a single ‘treated’ unit and compared with a unit created using data from LAs that were not UEC vanguards partners to estimate the impact of UEC vanguards on DTOC. Sensitivity analysis included fixed effects panel regressions and various placebo tests.

Setting

150 LAs in England (excluding city of London and Isles of Scilly); 29 LAs were partners in UEC vanguards between August 2015 and March 2018.

Primary outcome measure

Quarterly data on days of DTOC at LA level for the period 2010–2017.

Results

Synthetic control estimation showed a large difference in DTOC days between UEC vanguards partner LAs compared with those that were not, with on average 23.7% lower DTOC per quarter (491 DTOC days per quarter). Fixed effect panel regressions found DTOC rates lower by 43.1% (99% CI 13.8% to 72.4%) in UEC partner LAs after the start of the vanguards programme. We found no indication of UEC partner LAs having lower DTOC rates prior to initiation of vanguards.

Conclusions

The evidence indicates a sizeable statistically significant impact of UEC vanguards on DTOC; however, more research is required to explain the underlying reasons for this relationship.

DOI: https://doi.org/10.1136/bmjopen-2021-054568

Authors - Carole Fogg, Simon D. S. Fraser, Paul Roderick, Simon de Lusignan, Andrew Clegg, Sally Brailsford, Abigail Barkham, Harnish P. Patel, Vivienne Windle, Scott Harris, Shihua Zhu, Tracey England, Dave Evenden, Francesca Lambert, Bronagh Walsh & The Frailty Dynamics study team.

https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-021-02684-y

Abstract

Background

Frailty is a common condition in older adults and has a major impact on patient outcomes and service use. Information on the prevalence in middle-aged adults and the patterns of progression of frailty at an individual and population level is scarce. To address this, a cohort was defined from a large primary care database in England to describe the epidemiology of frailty and understand the dynamics of frailty within individuals and across the population. This article describes the structure of the dataset, cohort characteristics and planned analyses.

Methods

Retrospective cohort study using electronic health records. Participants were aged ≥50 years registered in practices contributing to the Oxford Royal College of General Practitioners Research and Surveillance Centre between 2006 to 2017. Data include GP practice details, patient sociodemographic and clinical characteristics, twice-yearly electronic Frailty Index (eFI), deaths, medication use and primary and secondary care health service use. Participants in each cohort year by age group, GP and patient characteristics at cohort entry are described.

Results

The cohort includes 2,177,656 patients, contributing 15,552,946 person-years, registered at 419 primary care practices in England. The mean age was 61 years, 52.1% of the cohort was female, and 77.6% lived in urban environments. Frailty increased with age, affecting 10% of adults aged 50–64 and 43.7% of adults aged ≥65. The prevalence of long-term conditions and specific frailty deficits increased with age, as did the eFI and the severity of frailty categories.

Conclusion

A comprehensive understanding of frailty dynamics will inform predictions of current and future care needs to facilitate timely planning of appropriate interventions, service configurations and workforce requirements. Analysis of this large, nationally representative cohort including participants aged ≥50 will capture earlier transitions to frailty and enable a detailed understanding of progression and impact. These results will inform novel simulation models which predict future health and service needs of older people living with frailty.

DOI: https://doi.org/10.1186/s12877-021-02684-y

Authors - Joe Hollinghurst, Helen Daniels, Richard Fry, Ashley Akbari, Sarah Rodgers, Alan Watkins, Sarah Hillcoat-Nallétamby, Neil Williams, Silviya Nikolova, David Meads, Andy Clegg

https://academic.oup.com/ageing/article/51/1/afab201/6399893

Abstract

Background

falls are common in older people, but evidence for the effectiveness of preventative home adaptations is limited.

Aim

determine whether a national home adaptation service, Care&Repair Cymru (C&RC), identified individuals at risk of falls occurring at home and reduced the likelihood of falls.

Study Design

retrospective longitudinal controlled non-randomised intervention cohort study.

Setting

our cohort consisted of 657,536 individuals aged 60+ living in Wales (UK) between 1 January 2010 and 31 December 2017. About 123,729 individuals received a home adaptation service.

Methods

we created a dataset with up to 41 quarterly observations per person. For each quarter, we observed if a fall occurred at home that resulted in either an emergency department or an emergency hospital admission. We analysed the data using multilevel logistic regression.

Results

compared to the control group, C&RC clients had higher odds of falling, with an odds ratio (OR [95% confidence interval]) of 1.93 [1.87, 2.00]. Falls odds was higher for females (1.44 [1.42, 1.46]), older age (1.07 [1.07, 1.07]), increased frailty (mild 1.57 [1.55, 1.60], moderate 2.31 [2.26, 2.35], severe 3.05 [2.96, 3.13]), and deprivation (most deprived compared to least: 1.16 [1.13, 1.19]). Client fall odds decreased post-intervention; OR 0.97 [0.96, 0.97] per quarter. Regional variation existed for falls (5.8%), with most variation at the individual level (31.3%).

Conclusions

C&RC identified people more likely to have an emergency fall admission occurring at home, and their service reduced the odds of falling post-intervention. Service provisioning should meet the needs of an individual and need varies by personal and regional circumstance.

2021

Authors - Nicola Harrison, Caroline Brundle, Anne Heaven, Andrew Clegg

https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05297-3

Abstract

Background

To support a robust evidence base for the organisation and provision of community-delivered health services for older people, clinical trials need to be designed to account for community-based participant recruitment. There is currently little reported information available on the time and cost of recruiting community-dwelling older people, which makes the completion of cost attribution documentation problematic when applying for research funding.

Main body

We aimed to establish the amount of researcher time it takes to recruit community-dwelling older people to a feasibility primary care cluster randomised controlled trial, including collecting baseline data. The trial was part of a programme of work investigating an intervention to improve the quality of life for older people with frailty. Two researchers conducting home visits to recruit and collect baseline data from participants recorded the time spent on travelling to and from the visit, at the visit itself and any associated administration. The median total researcher activity time per visit was 148 min. We discuss the various elements of recruitment and data collection activity and the factors that impacted the length of time taken, including location, individuals’ capacity and cognition, hearing and visual impairment and the desire for social contact.

Conclusion

Studies cannot reach their recruitment targets if they are unrealistically planned and resourced. We recommend that trials recruiting older people in the community allocate two and a half hours of researcher time per person, on average, for consent, baseline data collection, travel and administration. We acknowledge that a variety of different factors will mean that researcher activity will vary between different community-based trials. Our findings give a good starting point for timing calculations, and evidence on which to base the justification of research activity costings.

Authors - Chris Wilkinson, Andrew Clegg, Oliver Todd, Kenneth Rockwood, Mohammad E Yadegarfar, Chris P Gale, Marlous Hall

https://academic.oup.com/ageing/article/50/3/772/6035279

Background

Atrial fibrillation (AF) is common in older people and is associated with increased stroke risk that may be reduced by oral anticoagulation (OAC). Frailty also increases with increasing age, yet the extent of OAC prescription in older people according to extent of frailty in people with AF is insufficiently described.

Methods

An electronic health records study of 536,955 patients aged ≥65 years from ResearchOne in England (384 General Practices), over 15.4 months, last follow-up 11th April 2017. OAC prescription for AF with CHA2DS2-Vasc ≥2, adjusted (demographic and treatments) risk of all-cause mortality, and subsequent cerebrovascular disease, bleeding and falls were estimated by electronic frailty index (eFI) category of fit, mild, moderate and severe frailty.

Results

AF prevalence and mean CHA2DS2-Vasc for those with AF increased with increasing eFI category (fit 2.9%, 2.2; mild 11.2%, 3.2; moderate 22.2%, 4.0; and severe 31.5%, 5.0). For AF with CHA2DS2-Vasc ≥2, OAC prescription was higher for mild (53.2%), moderate (55.6%) and severe (53.4%) eFI categories than fit (41.7%). In those with AF and eligible for OAC, frailty was associated with increased risk of death (HR for severe frailty compared with fit 4.09, 95% confidence interval 3.43–4.89), gastrointestinal bleeding (2.17, 1.45–3.25), falls (8.03, 4.60–14.03) and, among women, stroke (3.63, 1.10–12.02).

Conclusion

Among older people in England, AF and stroke risk increased with increasing degree of frailty; however, OAC prescription approximated 50%. Given competing demands of mortality, morbidity and stroke prevention, greater attention to stratified stroke prevention is needed for this group of the population.

Authors - Nikolova S, Heaven A, Hulme C, West R, Pendleton N, Humphrey S, Cundill B, Clegg A.

https://onlinelibrary.wiley.com/doi/10.1111/hsc.13450

Abstract

International evidence indicates that older people with frailty are more likely to access social care services, compared to nonfrail older people. There is, however, no robust evidence on costs of social care provided for community-dwelling older people living with frailty in their own homes. The main objective of this study was to examine the relationship between community-dwelling older people living with frailty, defined using the cumulative deficit model, and annual formal social care costs for the 2012–2018 period. A secondary objective was to estimate formal social care spending for every 1% reduction in the number of older people who develop frailty over 1 year. Secondary analysis of prospective cohort data from two large nationally representative community-based cohort studies in England was performed. Respondents aged ≥75 were used in the main analysis and respondents aged 65–74 in sensitivity testing. We used regression tree modelling for formal social care cost analysis including frailty, age, gender, age at completing education and living with partner as key covariates. We employed a minimum node size stopping criteria to limit tree complexity and overfitting and applied ‘bootstrap aggregating’ to improve robustness. We assessed the impact of an intervention for every 1% decrease in the number of individuals who become frail over 1 year in England. Results show that frailty is the strongest predictor of formal social care costs. Mean social care costs for people who are not frail are £321, compared with £2,895 for individuals with frailty. For every 1% of nonfrail people not transitioning to frailty savings of £4.4 million in annual expenditures on formal social care in England are expected, not including expenditure on care homes. Given considerably higher costs for individuals classed as frail compared to nonfrail, a successful intervention avoiding or postponing the onset of frailty has the potential to considerably reduce social care costs.

Authors - Miles D Witham, Philip Heslop, Richard M Dodds, Andrew P Clegg, Suzy V Hope, Claire McDonald, David Smithard, Bryony Storey, Ai Lyn Tan, Anna Thornhill, Avan A Sayer

https://academic-oup-com.eres.qnl.qa/ageing/article/50/5/1762/6284387

Abstract

Background

sarcopenia registries are a potential method to meet the challenge of recruitment to sarcopenia trials. We tested the feasibility of setting up a UK sarcopenia registry, the feasibility of recruitment methods and sought to characterise the pilot registry population.

Methods

six diverse UK sites took part, with potential participants aged 65 and over approached via mailshots from local primary care practices. Telephone pre-screening using the SARC-F score was followed by in-person screening and baseline visit. Co-morbidities, medications, grip strength, Short Physical Performance Battery, bioimpedance analysis, Geriatric Depression Score, Montreal Cognitive Assessment, Sarcopenia Quality of Life score were performed and permission sought for future recontact. Descriptive statistics for recruitment rates and baseline measures were generated; an embedded randomised trial examined the effect of a University logo on the primary care mailshot on recruitment rates.

Results

sixteen practices contributed a total of 3,508 letters. In total, 428 replies were received (12% response rate); 380 underwent telephone pre-screening of whom 215 (57%) were eligible to attend a screening visit; 150 participants were recruited (40% of those pre-screened) with 147 contributing baseline data. No significant difference was seen in response rates between mailshots with and without the logo (between-group difference 1.1% [95% confidence interval −1.0% to 3.4%], P = 0.31). The mean age of enrollees was 78 years; 72 (49%) were women. In total, 138/147 (94%) had probable sarcopenia on European Working Group on Sarcopenia 2019 criteria and 145/147 (98%) agreed to be recontacted about future studies.

Conclusion

recruitment to a multisite UK sarcopenia registry is feasible, with high levels of consent for recontact.

Authors - Hinde, Sebastian; Bojke, Laura; Richardson, Gerry; Birks, Yvonne Frances; Whittaker, William; Wilberforce, Mark Robson; Clegg, Andrew.

https://academic.oup.com/ageing/article/50/4/1073/6150370

Abstract

Delayed transfers of care (DTOC), often unhelpfully referred to as ‘bed blocking’, has become a byword for waste and inefficiency in healthcare systems throughout the world. An estimated 2.7 million bed days are occupied each year in England by older people no longer in need of acute treatment, estimated to cost £820 million (2014/15) in inpatient care. Policy and media attention have often been drawn to this narrative of financial waste, resulting in policy setting that directly targets the level of DTOC, but has done little to put patient health first.

These figures and policies portray a misleading image of the delays as primarily of concern in terms of their financial burden on acute hospital care, with little consideration given to the quantification on patient health or wider societal impacts. In spite of the multi-factorial decision-making process that occurs for each patient discharge, current evaluation frameworks and national policy setting fail to reflect the complexity of the process.

In this commentary, we interrogate the current approach to the quantification of the DTOC impact and explore how policies and evaluation methods can do more to reflect the true impact of the delays.

Crocker, T.F. et al (2021) Community-based complex interventions to sustain independence in older people, stratified by frailty: a protocol for a systematic review and network meta-analysis

Authors - Thomas F Crocker, Andrew Clegg, Richard D. Riley, Natalie Lam, Ram Bajpai, Magda Jordão, Eleftheria Patetsini, Ridha Ramiz, Joie Ensor, Anne Forster, John R F Gladman

https://bmjopen.bmj.com/content/11/2/e045637

Introduction

Maintaining independence is a primary goal of community health and care services for older people, but there is currently insufficient guidance about which services to implement. Therefore, we aim to synthesise evidence on the effectiveness of community-based complex interventions to sustain independence for older people, including the effect of frailty, and group interventions to identify the best configurations.

Methods and analysis

Systematic review and network meta-analysis (NMA). We will include randomised controlled trials (RCTs) and cluster RCTs of community-based complex interventions to sustain independence for older people living at home (mean age ≥65 years), compared with usual care or another complex intervention. We will search MEDLINE (1946 to September 2020), Embase (1947 to September 2020), CINAHL (1981 to September 2020), PsycINFO (1806 to September 2020), CENTRAL and clinical trial registries from inception to September 2020, without date/language restrictions, and scan included papers’ reference lists. Main outcomes were: living at home, activities of daily living (basic/instrumental), home-care services usage, hospitalisation, care home admission, costs and cost effectiveness. Additional outcomes were: health status, depression, loneliness, falls and mortality. Interventions will be coded, summarised and grouped. An NMA using a multivariate random-effects model for each outcome separately will determine the relative effects of different complex interventions. For each outcome, we will produce summary effect estimates for each pair of treatments in the network, with 95% CI, ranking plots and measures, and the borrowing of strength statistic. Inconsistency will be examined using a ‘design-by-treatment interaction’ model. We will assess risk of bias (Cochrane tool V.2) and certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation for NMA approach.

Ethics and dissemination

This research will use aggregated, anonymised, published data. Findings will be reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance. They will be disseminated to policy-makers, commissioners and providers, and via conferences and scientific journals.

2020

Authors - Chris Wilkinson, Jianhua Wu, Samuel D. Searle, Oliver Todd, Marlous Hall, Vijay Kunadian, Andrew Clegg, Kenneth Rockwood & Chris P. Gale

https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-020-01870-w

Abstract

Background

Atrial fibrillation (AF) is common in older people with frailty and is associated with an increased risk of stroke and systemic embolism. Whilst oral anticoagulation is associated with a reduction in this risk, there is a lack of data on the safety and efficacy of direct oral anticoagulants (DOACs) in people with frailty. This study aims to report clinical outcomes of patients with AF in the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation–Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) trial by frailty status.

Methods

Post hoc analysis of 20,867 participants in the ENGAGE AF-TIMI 48 trial, representing 98.8% of those randomised. This double-blinded double-dummy trial compared two once-daily regimens of edoxaban (a DOAC) with warfarin. Participants were categorised as fit, living with pre-frailty, mild-moderate, or severe frailty according to a standardised index, based upon the cumulative deficit model. The primary efficacy endpoint was stroke or systemic embolism and the safety endpoint was major bleeding.

Results

A fifth (19.6%) of the study population had frailty (fit: n = 4459, pre-frailty: n = 12,326, mild-moderate frailty: n = 3722, severe frailty: n = 360). On average over the follow-up period, the risk of stroke or systemic embolism increased by 37% (adjusted HR 1.37, 95% CI 1.19–1.58) and major bleeding by 42% (adjusted HR 1.42, 1.27–1.59) for each 0.1 increase in the frailty index (four additional health deficits). Edoxaban was associated with similar efficacy to warfarin in every frailty category, and a lower risk of bleeding than warfarin in all but those living with severe frailty.

Conclusions

Edoxaban was similarly efficacious to warfarin across the frailty spectrum and was associated with lower rates of bleeding except in those with severe frailty. Overall, with increasing frailty, there was an increase in stroke and bleeding risk. There is a need for high-quality, frailty-specific population randomised control trials to guide therapy in this vulnerable population.

Trial registration

ClinicalTrials.gov NCT00781391. First registered on 28 October 2008

Authors - Peter A Coventry, Dean McMillan, Andrew Clegg, Lesley Brown, Christina van der Feltz-Cornelis, Simon Gilbody, Shehzad Ali

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0243972

Abstract

Objectives

To evaluate if depression contributes, independently and/or in interaction with frailty, to loss of independence in instrumental activities of daily living (ADL) in older adults with frailty.

Methods

Longitudinal cohort study of people aged ≥75 years living in the community. We used multi-level linear regression model to quantify the relationship between depression (≥5 Geriatric Depression Scale) and frailty (electronic frailty index), and instrumental activities of daily living (Nottingham Extended Activities of Daily Living scale; range: 0–66; higher score implies greater independence). The model was adjusted for known confounders (age; gender; ethnicity; education; living situation; medical comorbidity).

Results

553 participants were included at baseline; 53% were female with a mean age of 81 (5.0 SD) years. Depression and frailty (moderate and severe levels) were independently associated with reduced instrumental activities of daily living scores. In the adjusted analysis, the regression coefficient was -6.4 (95% CI: -8.3 to -4.5, p<0.05) for depression, -1.5 (95% CI: -3.8 to 0.9, p = 0.22) for mild frailty, -6.1 (95% CI: -8.6 to -3.6, p<0.05) for moderate frailty, and -10.1 (95% CI: -13.5 to -6.8, p<0.05) for severe frailty. Moreover, depression interacted with frailty to further reduce instrumental activities of daily living score in individuals with mild or moderate frailty. These relationships remained significant after adjusting for confounders.

Conclusion

Frailty and depression are independently associated with reduced independence in instrumental activities of daily living. Also, depression interacts with frailty to further reduce independence for mild to moderately frail individuals, suggesting that clinical management of frailty should integrate physical and mental health care.

Authors - Joe Hollinghurst, Gemma Housley, Alan Watkins, Andrew Clegg, Thomas Gilbert, Simon P Conroy

https://academic.oup.com/ageing/article/50/4/1208/6012377

Abstract

Background

The electronic Frailty Index (eFI) has been developed in primary care settings. The Hospital Frailty Risk Score (HFRS) was derived using secondary care data.

Objective

Compare the two different tools for identifying frailty in older people admitted to hospital.

Design and Setting

Retrospective cohort study using the Secure Anonymised Information Linkage Databank, comprising 126,600 people aged 65+ who were admitted as an emergency to hospital in Wales from January 2013 up until December 2017.

Methods

Pearson’s correlation coefficient and weighted kappa were used to assess the correlation between the tools. Cox and logistic regression were used to estimate hazard ratios (HRs) and odds ratios (ORs). The Concordance statistic and area under the receiver operating curves (AUROC) were estimated to determine discrimination.

Results

Pearson’s correlation coefficient was 0.26 and the weighted kappa was 0.23. Comparing the highest to the least frail categories in the two scores the HRs for 90-day mortality, 90-day emergency readmission and care home admissions within 1-year using the HFRS were 1.41, 1.69 and 4.15 for the eFI 1.16, 1.63 and 1.47. Similarly, the ORs for inpatient death, length of stay greater than 10 days and readmission within 30-days were 1.44, 2.07 and 1.52 for the HFRS, and 1.21, 1.21 and 1.44 for the eFI. AUROC was determined as having no clinically relevant difference between the tools.

Conclusions

The eFI and HFRS have a low correlation between their scores. The HRs and ORs were higher for the increasing frailty categories for both the HFRS and eFI.

Authors - Miriam Veenhuizen, Oliver Todd, Atul Anand, Will Whiteley

https://academic.oup.com/ageing/article/50/3/996/5924102

Abstract

Introduction

At all ages, randomised trials demonstrate lower mortality and cardiovascular disease incidence with blood pressure (BP) lowering. However, this may not generalise to older people with frailty. We aimed to determine the acceptability to clinicians of key aspects of trial designs using different BP targets and strategies to better manage hypertension in the context of frailty.

Methods

We conducted a multinational survey of clinicians managing hypertension in older people, distributed using an online survey link amongst professional societies and social networks. Questions described case histories of patients who were frail with different systolic blood pressures (SBP), treatment target, strategy and target trial population.

Results

In total, 114 responses were received (48 primary care, 66 secondary care). A majority would consider recruiting patients to a trial of relaxing treatment in those whose SBP < 130 mm Hg; a majority would consider recruiting to a trial intensifying treatment in patients with SBP > 150 mm Hg. Respondents elected to intensify treatment by: choosing the next step by NICE guidelines, adding a new treatment agent at full dose, or adding two agents at half dose.

Conclusion

A majority of clinicians surveyed would recruit older people to a trial intensifying treatment where SBP is more than 150 mm Hg and where patients have high cardiovascular risk or to a trial relaxing treatment where the SBP is below 130 mm Hg and where the patient has frailty.

Authors - Brown L, Mossabir R, Harrison N, Brundle C, Smith J, Clegg A

https://academic.oup.com/ageing/article/50/2/341/5970510

Abstract

Background

In response to the coronavirus disease 2019 (COVID-19) pandemic, the UK government introduced social distancing measures and identified specific populations at high risk from the virus. People ≥70 were deemed ‘Clinically Vulnerable’. Distancing measures were introduced to reduce the risk of contracting COVID-19. However, these may have a negative impact on older people who are vulnerable to social isolation and may have challenges accessing services and provisions.

Objectives

To investigate the impact of COVID-19 lockdown measures on the lives of older people.

Study design and setting

Cross-sectional telephone survey.

Participants

Community-dwelling older people, 76–97 years.

Outcomes

Health anxiety; General health (RAND Short-form 36 Survey); Physical activity; Depression (PHQ-8); Anxiety (GAD-2); Loneliness; Access to services; Challenges, concerns and positive experiences.

Data analysis

Counts (%), means (SDs). Thematic analysis was used to identify themes from open questions.

Results

n = 142. 52% did not worry about their health; 76% rated their health as ‘good’, ‘very good’ or ‘excellent’; <10% met the criteria indicative of depression (PHQ-8), or anxiety (GAD-2); 42% were less active than before lockdown; and 27% were lonely at least some of the time. Over half of participants identified positive aspects.

Conclusions

Most participants reported good health with low levels of health anxiety, anxiety and depression. Many were able to identify positive aspects to lockdown and may be better equipped to deal with lockdown than anticipated. Strategies may be required to ameliorate the negative impact of loneliness for a minority of older people, and help some resume previous activity levels and pursuits.

Authors - Theresa Munyombwe, Robert M. West, Neil Pendleton, Andrew Clegg

https://agmr.hapres.com/htmls/AGMR_1308_Detail.html

ABSTRACT

Background

The electronic Frailty Index (eFI) was developed and validated using routinely available primary care electronic health record data. This study aims to develop mapping function for mapping between the eFI and a research standard frailty index validated as part of the English Longitudinal Study of Ageing (ELSA). Mapping eFI and ELSA frailty index (ELSAFI) measures could help facilitate the translation of research findings into clinical practice.

Method

Data from the Community Ageing Research 75+ (CARE75+) UK prospective cohort was used in this research. Regression analysis was used to develop mapping functions that can be used for translating the eFI into ELSAFI and vice versa. The predictive performance of the mapping function was evaluated using the Root Mean Square Error (RMSE), Mean Average Error (MAE), adjusted R square, and parsimony.

Results

A total of 896 individual cases was included in the analysis. The mean age of participants was 82.9 years (SD = 5.1) and 54.9% were females. There was positive correlation between the eFI and ELSAFI, r = 0.60. The mapping function of ELSAFI to eFI explained 38% of the variance in the derivation sample whilst the mapping algorithm of eFI to ELSAFI explained 40%. Both mapping functions had RMSE of 0.09.

Conclusion

The eFI can accurately be mapped on to a research standard ELSAFI and vice versa at the group level but not at individual level. Further testing is required to validate the mapping functions developed in this study in independent samples.

Authors - Joe Hollinghurst, Richard Fry, Ashley Akbari, Alan Watkins, Neil Williams, Sarah Hillcoat-Nallétamby, Ronan A Lyons, Andrew Clegg, Sarah E Rodgers

https://academic.oup.com/ageing/article/49/6/1056/5907944

Abstract

Background

home advice and modification interventions aim to promote independent living for those living in the community, but quantitative evidence of their effectiveness is limited.

Aim

assess the risk of care home admissions for people with different frailty levels receiving home advice and modification interventions against a control group who do not.

Study design and setting

matched control evaluation using linked longitudinal data from the Secure Anonymised Information Linkage (SAIL) Databank, comprising people aged 60–95, registered with a SAIL contributing general practice. The intervention group received the Care & Repair Cymru (C & RC) service, a home advice and modification service available to residents in Wales.

Methods

frailty, age and gender were used in propensity score matching to assess the Hazard Ratio (HR) of care home admissions within a 1-, 3- and 5-year period for the intervention group (N = 93,863) compared to a matched control group (N = 93,863). Kaplan–Meier curves were used to investigate time to a care home admission.

Results

the intervention group had an increased risk of a care home admission at 1-, 3- and 5-years [HR (95%CI)] for those classified as fit [1-year: 2.02 (1.73, 2.36), 3-years: 1.87 (1.72, 2.04), 5-years: 1.99 (1.86, 2.13)] and mildly frail [1-year: 1.25 (1.09, 1.42), 3-years: 1.25 (1.17, 1.34), 5-years: 1.30 (1.23, 1.38)], but a reduced risk of care home admission for moderately [1-year: 0.66 (0.58, 0.75), 3-years: 0.75 (0.70, 0.80), 5-years: 0.83 (0.78, 0.88)] and severely frail individuals [1-year: 0.44 (0.37, 0.54), 3-years: 0.54 (0.49, 0.60), 5-years: 0.60(0.55, 0.66)].

Conclusions

HRs indicated that the C & RC service helped to prevent care home admissions for moderately and severely frail individuals. The HRs generally increased with follow-up duration.

Authors - Matthew Hale, Hadar Zaman, David Mehdizadeh, Oliver Todd, Harriet Callaghan, Chris P. Gale & Andrew Clegg

https://link.springer.com/article/10.1007/s40266-020-00798-3

Abstract

Background

Statins reduce the risk of major adverse cardiovascular events (MACE), however their clinical benefit for primary and secondary prevention among older adults with frailty is uncertain. This systematic review investigates whether statins prescribed for primary and secondary prevention are associated with reduced MACE among adults aged ≥ 65 years with frailty.

Methods

We conducted a systematic review of studies published between 1 January 1952 and 1 January 2019 in the MEDLINE, EMBASE, Scopus, Web of Science, Cochrane Library and International Pharmaceutical Abstracts databases. Studies that investigated the effect of statins on MACE among adults ≥ 65 years of age with a validated frailty assessment were included. Data were extracted from the papers as per a prepublished protocol, PROSPERO: CRD42019127486. Risk of bias was assessed using the Cochrane Risk of Bias in Non-Randomised Studies of Interventions tool.

Results

Six cohort studies fulfilled the inclusion criteria; there were no randomised clinical trials. Among studies evaluating the association between statins for primary and secondary prevention and mortality, one study found statins were associated with reduced mortality (hazard ratio [HR] 0.58, 95% confidence interval [CI] 0.37–0.93), while another study found they were not (HR 0.81, 95% CI 0.61–1.08). Furthermore, one study of statins used for secondary prevention found they were associated with reduced mortality (HR 0.28, 95% CI 0.21–0.39). No studies investigated the effect of statins for primary prevention or the effect of statins on the frequency of MACE.

Conclusion

This review identified only observational evidence that among older people with frailty, statins are associated with reduced mortality when prescribed for secondary prevention, and an absence of evidence evaluating statin therapy for primary prevention. Randomised trial data are needed to better inform the use of statins among older adults living with frailty.

Authors - Spilsbury, K, Devi, R, Griffiths, A, Akrill, C, Astle, A, Goodman, C, Gordon, A, Hanratty, B, Hodkinson, P, Marshall, F, Meyer, J, Thompson

https://academic.oup.com/ageing/article/50/2/335/5905867

Abstract

The care and support of older people residing in long-term care facilities during the COVID-19 pandemic has created new and unanticipated uncertainties for staff. In this short report, we present our analyses of the uncertainties of care home managers and staff expressed in a self-formed closed WhatsApp™ discussion group during the first stages of the pandemic in the UK. We categorised their wide-ranging questions to understand what information would address these uncertainties and provide support. We have been able to demonstrate that almost one-third of these uncertainties could have been tackled immediately through timely, responsive and unambiguous fact-based guidance. The other uncertainties require appraisal, synthesis and summary of existing evidence, commissioning or provision of a sector- informed research agenda for medium to long term. The questions represent wider internationally relevant care home pandemic-related uncertainties.

Authors - Silviya Nikolova, Claire Hulme, Robert West, Neil Pendleton, Anne Heaven, Peter Bower, Sara Humphrey, Amanda Farrin, Bonnie Cundill, Rebecca Hawkins, Andrew Clegg

https://www.valueinhealthjournal.com/article/S1098-3015(20)32102-1/fulltext?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS1098301520321021%3Fshowall%3Dtrue

Abstract

Background

Previous studies have summarized evidence on health-related quality of life for older people, identifying a range of measures that have been validated, but have not sought to present results by degree of frailty. Furthermore, previous studies did not typically use quality-of-life measures that generate an overall health utility score. Health utility scores are a necessary component of quality-adjusted life-year calculations used to estimate the cost-effectiveness of interventions.

Methods

We calculated normative estimates in mean and standard deviation for EQ-5D-5L, short-form 36-item health questionnaire in frailty (SF-36), and short-form 6-dimension (SF-6D) for a range of established frailty models. We compared response distributions across dimensions of the measures and investigated agreement using Bland-Altman and interclass correlation techniques.

Results

The EQ-5D-5L, SF-36, and SF-6D scores decrease and their variability increases with advancing frailty. There is strong agreement between the EQ-5D-5L and SF-6D across the spectrum of frailty. Agreement is lower for people who are most frail, indicating that different components of the 2 instruments may have greater relevance for people with advancing frailty in later life. There is a greater risk of ceiling effects using the EQ-5D-5L rather than the SF-6D.

Conclusions

We recommend the SF-36/SF-6D as an appropriate measure of health-related quality of life for clinical trials if fit older people are the planned target. In trials of interventions involving older people with increasing frailty, we recommend that both the EQ-5D-5L and SF36/SF6D are included, and are used in sensitivity analyses as part of cost-effectiveness evaluation.

Authors - Barbara Hanratty, Jennifer Kirsty Burton, Claire Goodman, Adam L Gordon, Karen Spilsbury

https://www.bmj.com/content/369/bmj.m2463

The pandemic has shed harsh light on the need for a live minimum dataset

Residents of care homes are centre stage in the covid-19 pandemic for all the wrong reasons. Home to vulnerable people with complex needs, these settings should have been an obvious focus and priority in pandemic planning. Almost half of newly admitted residents in the UK are transferred from hospitals, creating a resident population with wide ranging needs spread across 450,000 beds in almost 11,000 homes. This is more than double the number of beds in NHS hospitals, but unlike NHS facilities most homes are privately owned, with residents responsible for some or all of the costs of their care. Yet as covid-19 spread across the UK, minutes suggest that the government’s Scientific Advisory Group for Emergencies (SAGE) discussed care homes only twice in the first five months of 2020.

The covid-19 pandemic has placed a spotlight on how little is known about this sector, and the lack of easily accessible, aggregated data on the UK care home population. Basic information that could be used to inform service responses, such as the number of residents in homes with and without nursing care, and hospital admissions and deaths among them, is difficult to locate. It is not simply lack of data that is the problem, it is the number of different bodies that are collecting information, and the absence of standardisation and cross sector cooperation in how data are collated, shared, and used.

Care homes collect and use data every day on the needs, health, and wellbeing of their residents, and a growing number of homes have sophisticated information systems to monitor medications, support care planning, and much more. Health services also keep routine records about homes’ residents, but these data are, rightly, difficult to access. External bodies such as the Care Quality Commission in England and the Care Inspectorate in Scotland collect information for regulation and quality assurance, including data on deaths and disease outbreaks. Figures on staffing are collated by managers’ organisation Skills for Care and the Scottish Social Services Council. None of these sources, however, provide timely information in a usable format that could inform urgent responses to the covid-19 pandemic.

Real time data

Some of the most innovative responses to the pandemic have emerged at regional level. For example, Health Innovation Manchester has a care data tracker that allows homes to provide real time information about residents to general practices and hospitals. In north east England digital collection of national early warning scores and linking of routine health and social care data has accelerated during the pandemic. And a capacity tracking app was introduced in England to generate data on care home bed occupancy and staffing.

To date there has been no national, systematic approach in the UK to develop care home datasets or to exploit their full potential to enhance residents’ care. We are collaborating on a study to design, develop, and implement a minimum dataset for UK care homes such as that developed in the US for the Centers for Medicare and Medicaid Services. The learning from covid-19 will directly inform this work, and we intend that any minimum dataset built for UK care homes should be a resource to support residents’ care and not just a tool for regulation or cost containment.

Longitudinal data on infections and deaths in care homes would have allowed real time monitoring from the start of the pandemic, early detection of problems, and targeted appropriate interventions. This could have yielded insights into the natural course of covid-19 in care homes, underpinned evidence based guidance, and identified triggers for service responses. As patients were discharged from hospitals to care homes after treatment, data on the health of residents would have been invaluable to develop strategies to protect people at greatest risk and minimise further spread within homes. Such data could also inform the need for bespoke surveillance systems for future pandemic waves.

Other countries have introduced care home minimum datasets, but none have been adapted for, or adopted into, routine UK care. In the US nursing homes are federally mandated to contribute to a minimum dataset, and payments are contingent on participation. Related measures, such as the Resident Assessment Instrument and Dutch National Measurement of Care Problems, are in use in Europe. None, however, provide the comprehensive information at the individual resident, care home, or organisational levels needed for health monitoring, and all have faced challenges in implementation.

Timely and accessible data on residents’ health, wellbeing, and service use could support rational planning and delivery of care tailored to residents’ needs, something that UK health and social care sectors have often struggled to do. Data are also vital for research, and for monitoring equity in outcomes and access to care. Workloads are already high in care homes, though, and it is crucial that data collection is not a burden on staff.

This pandemic has focused public and political attention on the needs of people in care homes, exposing a long established gap in data intelligence and prioritisation of needs. Such information could have made the difference between rapid, effective responses and the high rates of infection and mortality that have been the hallmark of covid-19. Political decisions on the funding and organisation of social care over decades have led us to this point. As societies question these choices and seek better ways of looking after our older citizens, ensuring that care homes are part of a data system that works to support and protect residents must be a priority.

Acknowledgments

We thank the other members of the DACHA (Developing research resources and minimum data set for care homes’ adoption and use) study team: Gizdem Akdur, Lisa Irvine, Massirfufulay Musa, Sarah Kelly, Andy Cowan, Guy Peryer, Anne Killett, Priti Biswas, Jessica Blake, Ian Lang, Anne-Marie Towers, Susan Fortescue, Julienne Meyer, Adam Steventon, and Arne Walters. The DACHA study is funded by the National Institute for Health Research (NIHR) Health Service Research and Delivery programme (HS&DR NIHR127234) and supported by the NIHR ARC East of England. BH, ALG, and KS are supported by NIHR ARCs North East and North Cumbria, East Midlands, Yorkshire and Humber. The views expressed are those of the authors, and not necessarily those of the NIHR, NHS, or Department of Health and Social Care.

Authors - Anne Heaven, Peter Bower, Bonnie Cundill, Amanda Farrin, Marilyn Foster, Robbie Foy, Suzanne Hartley, Rebecca Hawkins, Claire Hulme, Sara Humphrey, Rebecca Lawton, Catriona Parker, Neil Pendleton, Robert West, John Young, Andrew Clegg

https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-020-00598-x

Abstract

Background

Frailty is characterised by increased vulnerability to falls, disability, hospitalisation and care home admission. However, it is relatively reversible in the early stages. Older people living with frailty often have multiple health and social issues which are difficult to address but could benefit from proactive, person-centred care. Personalised care planning aims to improve outcomes through better self-management, care coordination and access to community resources.

Methods

This feasibility cluster randomised controlled trial aims to recruit 400 participants from 11 general practice clusters across Bradford and Leeds in the north of England. Eligible patients will be aged over 65 with an electronic frailty index score of 0.21 (identified via their electronic health record), living in their own homes, without severe cognitive impairment and not in receipt of end of life care. After screening for eligible patients, a restricted 1:1 cluster-level randomisation will be used to allocate practices to the PROSPER intervention, which will be delivered over 12 weeks by a personal independence co-ordinator worker, or usual care. Following initial consent, participants will complete a baseline questionnaire in their own home including measures of health-related quality of life, activities of daily living, depression and health and social care resource use. Follow-up will be at six and 12 months. Feasibility outcomes relate to progression criteria based around recruitment, intervention delivery, retention and follow-up. An embedded process evaluation will contribute to iterative intervention optimisation and logic model development by examining staff training, intervention implementation and contextual factors influencing delivery and uptake of the intervention.

Discussion

Whilst personalised care planning can improve outcomes in long-term conditions, implementation in routine settings is poor. We will evaluate the feasibility of conducting a cluster randomised controlled trial of personalised care planning in a community population based on frailty status. Key objectives will be to test fidelity of trial design, gather data to refine sample size calculation for the planned definitive trial, optimise data collection processes and optimise the intervention including training and delivery.

Authors - M Farrow, J Biglands, S F Tanner, A Clegg, L Brown, E M A Hensor, P O'Connor, P Emery, A L Tan

https://link.springer.com/article/10.1007/s40520-020-01530-2

Abstract

Background

Skeletal muscles undergo changes with ageing which can cause sarcopenia that can result in frailty. Quantitative MRI may detect the muscle-deficit component of frailty which could help improve the understanding of ageing muscles.

Aims

To investigate whether quantitative MRI measures of T2, fat fraction (FF), diffusion tensor imaging and muscle volume can detect differences within the muscles between three age groups, and to assess how these measures compare with frailty index, gait speed and muscle power.

Methods

18 ‘young’ (18–30 years), 18 ‘middle-aged’ (31–68 years) and 18 ‘older’ (> 69 years) healthy participants were recruited. Participants had an MRI of their dominant thigh. Knee extension and flexion power and handgrip strength were measured. Frailty (English Longitudinal Study of Ageing frailty index) and gait speed were measured in the older participants.

Results

Young participants had a lower muscle MRI T2, FF and mean diffusivity than middle-aged and older participants; middle-aged participants had lower values than older participants. Young participants had greater muscle flexion and extension power, muscle volume and stronger hand grip than middle-aged and older participants; middle-aged participants had greater values than the older participants. Quantitative MRI measurements correlated with frailty index, gait speed, grip strength and muscle power.

Discussion

Quantitative MRI and strength measurements can detect muscle differences due to ageing. Older participants had raised T2, FF and mean diffusivity and lower muscle volume, grip strength and muscle power.

Conclusions

Quantitative MRI measurements correlate with frailty and muscle function and could be used for identifying differences across age groups within muscle.

Authors - Dr Ikhlaq Jacob, Farhat Mahmood, Dr Lesley Brown, Anne Heaven, Saim Mahmood, Professor Andrew Clegg

https://www.magonlinelibrary.com/doi/abs/10.12968/bjcn.2020.25.3.110

Abstract

Older people from a South Asian background, particularly Pakistanis, are under-represented in health research, possibly because their recruitment to studies is hampered by language barriers and cultural differences. This article describes the observations of two bi-lingual researchers (FM and IJ) who successfully recruited older people (≥75 years) from Bradford's South Asian population to the Community Ageing Research 75+ Study (CARE 75+), a longitudinal cohort study collecting an extensive range of health, social and economic outcome data. The researchers recruited non-English-speaking Pakistani participants, ensuring they were flexible with appointments to accommodate the wishes of family members, who were often present during consent and assessment visits. Using community language was an important facilitator, and questions (and constructs) were translated to the community dialect (Potwari). To date, 233 South Asian people have been invited to participate in CARE75+, and 78 have been recruited (recruitment rate=33%), of which 62 are of Pakistani origin. The observed recruitment rate for South Asian participants is comparable to that of the whole study population (36%). Language barriers should not be used as a basis for excluding participants from research studies. Appropriate facilitation, through skilled researchers who have knowledge of, and are attuned to, the cultural sensitivities of the community, can allow recruitment of BME participants to research studies.

Authors - Miles D Witham, Melody Chawner, Sarah De Biase, Natalie Offord, Oliver Todd, Andrew Clegg, Avan A Sayer

https://www.jfsf.eu/Article.php?AID=v05i01_017

Abstract

Objectives: To establish whether existing exercise programmes offered to people with sarcopenia or frailty adhere to the current evidence base. Methods: We conducted a national survey of practitioners delivering exercise programmes to older people with sarcopenia or frailty in the UK. The link to the online survey was distributed through email lists of professional societies, practice networks and social media. Questions covered target population and programme aims, type, duration and frequency of exercise, progress assessment and outcome measures. Results: One hundred and thirty-six responses were received. 94% of respondents reported prescribing or delivering exercise programmes to people with sarcopenia or frailty. Most programmes (81/135 [60%]) were primarily designed to prevent or reduce falls. Resistance training was the main focus in only 11/123 (9%), balance training in 61/123 (50%) and functional exercise in 28/123 (23%). Exercise was offered once a week or less by 81/124 (65%) of respondents. Outcome measures suitable for assessing the effect of resistance training programmes were reported by fewer than half of respondents (hand grip: 13/119 [11%]; chair stands: 55/119 [46%]). Conclusions: Current UK exercise programmes offered to older people with sarcopenia or frailty lack the specificity, frequency or duration of exercise likely to improve outcomes for this patient group.

Authors - Oliver M Todd, Jennifer K Burton, Richard M Dodds, Joe Hollinghurst, Ronan A Lyons, Terence J Quinn, Anna Schneider, Katherine E Walesby, Chris Wilkinson, Simon Conroy, Chris P Gale, Marlous Hall, Kate Walters, Andrew P Clegg

https://academic.oup.com/ageing/article/49/5/716/5733068

Abstract

The past three decades have seen a steady increase in the availability of routinely collected health and social care data and the processing power to analyse it. These developments represent a major opportunity for ageing research, especially with the integration of different datasets across traditional boundaries of health and social care, for prognostic research and novel evaluations of interventions with representative populations of older people. However, there are considerable challenges in using routine data at the level of coding, data analysis and in the application of findings to everyday care. New Horizons in applying routine data to investigate novel questions in ageing research require a collaborative approach between clinicians, data scientists, biostatisticians, epidemiologists and trial methodologists. This requires building capacity for the next generation of research leaders in this important area. There is a need to develop consensus code lists and standardised, validated algorithms for common conditions and outcomes that are relevant for older people to maximise the potential of routine data research in this group. Lastly, we must help drive the application of routine data to improve the care of older people, through the development of novel methods for evaluation of interventions using routine data infrastructure. We believe that harnessing routine data can help address knowledge gaps for older people living with multiple conditions and frailty, and design interventions and pathways of care to address the complex health issues we face in caring for older people.

2019

Authors - Muscedere J, Afilalo J, de Carvalho IA, Cesari M, Clegg A, Eriksen HE, Evans KR, Heckman G, Hirdes JP, Kim PM, Laffon B, Lynn J, Martin F, Prorok JC, Rockwood K, Manas LR, Rolfson D, Shaw G, Shea B, Sinha S, Theou O, Tugwell P, Valdiglesias V, Vellas B, Veronese N, Wallace LMK, Williamson PR, Network CF

https://link.springer.com/article/10.14283/jfa.2019.43

Abstract

With aging populations around the world, frailty is becoming more prevalent increasing the need for health systems and social systems to deliver optimal evidence based care. However, in spite of the growing number of frailty publications, high-quality evidence for decision making is often lacking. Inadequate descriptions of the populations enrolled including frailty severity and frailty conceptualization, lack of use of validated frailty assessment tools, utilization of different frailty instruments between studies, and variation in reported outcomes impairs the ability to interpret, generalize and implement the research findings. The utilization of common data elements (CDEs) and core outcome measures (COMs) in clinical trials is increasingly being adopted to address such concerns. To catalyze the development and use of CDEs and COMs for future frailty studies, the Canadian Frailty Network (http://www.cfn-nce.ca; CFN), a not-for-profit pan-Canadian nationally-funded research network, convened an international group of experts to examine the issue and plan the path forward. The meeting was structured to allow for an examination of current frailty evidence, ability to learn from other COMs and CDEs initiatives, discussions about specific considerations for frailty COMs and CDEs and finally the identification of the necessary steps for a COMs and CDEs consensus initiative going forward. It was agreed at the onset of the meeting that a statement based on the meeting would be published and herein we report the statement.

Authors - Matthew D Hale, Gillian Santorelli, Caroline Brundle, Andrew Clegg

https://academic.oup.com/ageing/article/49/1/135/5607677

Abstract

Background

Self-reported data regarding health conditions are utilised in both clinical practice and research, but their agreement with general practice records is variable. The extent of this variability is poorly studied amongst older adults, particularly amongst those with multiple health conditions, cognitive impairment or frailty. This study investigates the agreement between self-reported and general practice-recorded data amongst such patients and the impact of participant factors on this agreement.

Methods

Data on health conditions was collected from participants in the Community Ageing Research 75+ (CARE75+) study (n = 964) by self-report during face-to-face assessment and interrogation of the participants’ general practice electronic health records. Agreement between self-report and practice records was assessed using Kappa statistics and the effect of participant demographics using logistic regression.

Results

Agreement ranged from K = 0.25 to 1.00. The presence of ≥2 health conditions modified agreement for cancer (odds ratio, OR:0.62, 95%confidence interval, CI:0.42–0.94), diabetes (OR:0.55, 95%CI:0.38–0.80), dementia (OR:2.82, 95%CI:1.31–6.13) and visual impairment (OR:3.85, 95%CI:1.71–8.62). Frailty reduced agreement for cerebrovascular disease (OR:0.45, 95%CI:0.23–0.89), heart failure (OR:0.40, 95%CI:0.19–0.84) and rheumatoid arthritis (OR:0.41, 95%CI:0.23–0.75). Cognitive impairment reduced agreement for dementia (OR:0.36, 95%CI:0.21–0.62), diabetes (OR:0.47, 95%CI:0.33–0.67), heart failure (OR:0.53, 95%CI:0.35–0.80), visual impairment (OR:0.42, 95%CI:0.25–0.69) and rheumatoid arthritis (OR:0.53, 95%CI:0.37–0.76).

Conclusions

Significant variability exists for agreement between self-reported and general practice-recorded comorbidities. This is further affected by an individual’s health conditions. This study is the first to assess frailty as a factor modifying agreement and highlights the importance of utilising the general practice records as the gold standard for data collection from older adults.

Authors - Joe Hollinghurst, Richard Fry, Ashley Akbari, Andy Clegg, Ronan A Lyons, Alan Watkins, Sarah E Rodgers

https://academic.oup.com/ageing/article/48/6/922/5576114

Abstract

Background

frailty has major implications for health and social care services internationally. The development, validation and national implementation of the electronic Frailty Index (eFI) using routine primary care data has enabled change in the care of older people living with frailty in England.

Aims

to externally validate the eFI in Wales and assess new frailty-related outcomes.

Study design and setting

retrospective cohort study using the Secure Anonymised Information Linkage (SAIL) Databank, comprising 469,000 people aged 65–95, registered with a SAIL contributing general practice on 1 January 2010.

Methods

four categories (fit; mild; moderate and severe) of frailty were constructed using recognised cut points from the eFI. We calculated adjusted hazard ratios (HRs) from Cox regression models for validation of existing outcomes: 1-, 3- and 5-year mortality, hospitalisation, and care home admission for validation. We also analysed, as novel outcomes, 1-year mortality following hospitalisation and frailty transition times.

Results

HR trends for the validation outcomes in SAIL followed the original results from ResearchOne and THIN databases. Relative to the fit category, adjusted HRs in SAIL (95% CI) for 1-year mortality following hospitalisation were 1.05 (95% CI 1.03-1.08) for mild frailty, 1.24 (95% CI 1.21-1.28) for moderate frailty and 1.51 (95% CI 1.45-1.57) for severe frailty. The median time (lower and upper quartile) between frailty categories was 2,165 days (lower and upper quartiles: 1,510 and 2,831) from fit to mild, 1,155 days (lower and upper quartiles: 756 and 1,610) from mild to moderate and 898 days (lower and upper quartiles: 584 and 1,275) from moderate to severe.

Conclusions

further validation of the eFI showed robust predictive validity and utility for new outcomes.