Year: 2025
Type: article
Abstract: There is a popular misconception that researchers with an interest in clinical ageing don’t ‘do’ randomised controlled trials (RCTs). An implication of this, is that the major journals with a focus on frailty and other syndromes of ageing don’t include trials. Whilst there is still work for researchers in ageing to do if we wish to catch up with RCT activity in disciplines such as cardiology and oncology, the international portfolio of older adult trials is increasing year on year. In parallel, here in Age and Ageing, we are seeing a welcome increase in RCTs submitted to the journal. So, if you are running a trial with a focus on ageing then consider us. Significant disparities remain in RCT participation, raising concerns that the evidence base used to guide care may not be based on representative data. Historically, older adults, especially those living with frailty or multiple long-term conditions, have been excluded from RCTs, either directly through age-based exclusions, or indirectly through design. This month saw a ‘statement of intent’ from the Chief Medical Officer of England, signed by all major UK research funders, that the research community needs to do more to include older adults in trials. This month’s journal has a healthy selection of RCTs with older populations, and we look forward to seeing more RCTs in future editions of the journal. Loneliness is a significant concern amongst older adults, and a recognised risk factor for physical and mental health decline. The COVID-19 pandemic exacerbated social isolation, leaving many older adults particularly vulnerable. The Helping Alleviate Loneliness in Hong Kong Older Adults (HEAL-HOA) RCT [1] addressed this issue through layperson delivered telephone-based interventions. The 1151 older adults who participated in the trial were randomised to one of three groups, where all received eight 30-min telephone consultations over a 4-week period. For one group, the focus was on mindfulness, another behavioural activation, and the control was informal conversation. At 3 and 6 months follow-up, both mindfulness and behavioural activation groups demonstrated greater improvement than control in some, but not all, outcomes. The behavioural activation seemed to have greater, and more sustained, benefit. This RCT highlights the importance of accessible interventions that can reach vulnerable and socially excluded populations. The loneliness epidemic did not end with the cessation of covid social distancing and if these results can be replicated in other contexts, then there is an opportunity for a low cost, easily scalable, intervention for this major issue. Indirect benefits of this lay delivered programme could include fostering a sense of community, and reinforcing the importance of social connection for wellbeing. The rising prevalence of osteoarthritis, driven partly by the rise in obesity, is a growing concern due to its association with functional decline and other long-term conditions. Despite its importance, we have relatively few non-surgical interventions for this condition. The oestrogen on physical performance to muscle resistance exercise for older women with osteoarthritis of knee joint trial [2] explored the effect of transdermal oestrogen replacement, combined with resistance exercise, in older females with osteoarthritis. Seventy-five older adults participated in this randomised, double masked, placebo-controlled trial. Improvements were limited, and no significant differences were seen across various measures of function, although potential benefits were noted in those with early disease. This neutral result is not definitive evidence that oestrogen has no role in osteoarthritis. The sample size may not have been sufficient to demonstrate modest, but important, effects, and the older adults recruited were already relatively fit at baseline, so had little scope to improve further. Improved mental health outcomes in those receiving oestrogen replacement are an intriguing secondary outcome, and highlight the importance of holistic assessment and measuring what is important to trial participants. Continence and continence care are important issues to older adults, yet remain relatively under-researched. Many older adults living with frailty are resident in care-homes, yet care-homes are infrequently included in research. At the intersection of an under-researched topic, in an under-researched setting, comes the TENA SmartCare Change Indicator RCT [3]. The intervention in this trial was a device to alert staff to when a continence pad required to be changed. The comparator was usual care, which is often ad hoc ‘check and change’. The trial was cluster randomised, and the device was rolled out across 14 sites (108 residents). Using the SmartCare Change Indicator, did not significantly improve skin health, or efficiency of care—the pre-specified primary outcomes. However, skin health and care efficiency was already good in many of the participating care-homes, and larger study sizes may have been needed to demonstrate differences. Looking at other outcomes, the system reduced the number of pads used, and decreased sleep interruptions which may represent meaningful outcomes for care-home budgets, and residents’ quality of life. Whilst clinical trials provide crucial evidence, systematic reviews and meta-analyses allow broader evaluation and synthesis of the existing research to inform guidelines and policy. An area that would benefit from robust recommendations is around use of lipid lowering drugs and dementia. Whilst observational evidence has shown association between dyslipidaemia and dementia, there have been concerns that statins and other therapies may exacerbate cognitive decline. A meta-analysis of 20 RCTS, including over 100 000 patients, provides some answers [4]. Lipid lowering therapies were safe, but not associated with a significant reduction in dementia incidence. Many of the studies that informed this meta-analysis suffer from the limitations common to dementia prevention trials. Follow-up may not have been sufficiently long to show differences, and treatment may have been started too late to prevent the clinical syndromes. However, with so many older adults prescribed lipid lowering, it is reassuring to know that this therapy is not causing cognitive harm. A potential end result of more trials of novel medications, is that older adults are exposed to more and more drugs. Whilst individually all these medications may have benefits, polypharmacy and medication-related harm are significant challenges in older adult care. The common situation of living with multiple long-term conditions can necessitate complex medication regimes, resulting in increased risk of adverse drug reactions and other medication related harms. Identifying those at the greatest risk could improve prescribing, yet this is challenging due to the heterogeneity of the older adult population. The statistical technique of latent class analysis may provide a solution, by grouping older adults into subpopulations based on specific medications, frailty and polypharmacy. This approach was used in the Adverse Drug reactions in an Ageing PopulaTion cohort of 798 hospitalised older adults and identified subgroups at greatest risk [5]. Whilst promising, this approach requires validation in independent clinical settings before it could be considered universally applicable. The real test is whether prospectively identifying those at risk, leads to changes in prescribing practice, and whether these, in turn, lead to improved outcomes. Not an easy trial to design or conduct, but one that is urgently needed. From reading this Editor’s View you may be forgiven for thinking that Age and Ageing is exclusively concerned with trials and drugs. This is not the case, and all high quality research with a focus on clinical syndromes of ageing is very much welcome. The future researchers publishing in Age and Ageing need good early career training, but feeling confident in managing the complex healthcare needs of older adults, specifically around polypharmacy and frailty, can be a challenge for medical students. In the context of an ageing population, it is essential that the undergraduate curriculum provides medical students with the knowledge and skills to care for older adults. In this context, it is encouraging that the latest survey of UK, GMC registered, medical schools show steady improvements in the teaching time dedicated to older adult issues [6]. However, there remain important gaps in teaching provision, for example the lack of teaching on elder abuse is a significant concern. If medical students cannot recognise this issue, vulnerable older adults may not receive the help they need. The British Geriatrics Society undergraduate curriculum provides recommendations for undergraduate geriatric medicine teaching, and medical schools should align with this curriculum to ensure students are equipped to care for older adults and prepared for contemporary clinical practice.
Source: Age and Ageing
Authors: Sophie Alexandra Hay, Terence J Quinn
Language: English
Topic: Frailty in Older Adults
Subfield: Geriatrics and Gerontology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4414382086