Clinical trials in older people

Randomised controlled trials (RCTs) usually provide the best evidence for treatments and management. Historically, older people have often been excluded from clinical medication trials due to age, multimorbidity and disabilities. The situation is improving, but still the external validity of many trials may be questioned. Individuals participating in trials are generally less complex than many patients seen in geriatric clinics. Recruitment and retention of older participants are particular challenges in clinical trials. Multiple channels are needed for successful recruitment, and especially individuals experiencing frailty, multimorbidity and disabilities require support to participate. Cognitive decline is common, and often proxies are needed to sign informed consent forms. Older people may fall ill or become tired during the trial, and therefore, special support and empathic study personnel are necessary for the successful retention of participants. Besides the risk of participants dropping out, several other pitfalls may result in underestimating or overestimating the intervention effects. In nonpharmacological trials, imperfect blinding is often unavoidable. Interventions must be designed intensively and be long enough to reveal differences between the intervention and control groups, as control participants must still receive the best normal care available. Outcome measures should be relevant to older people, sensitive to change and targeted to the specific population in the trial. Missing values in measurements are common and should be accounted for when designing the trial. Despite the obstacles, RCTs in geriatrics must be promoted. Reliable evidence is needed for the successful treatment, management and care of older people.Non peer reviewe

Association of midlife value priorities with health-related quality of life, frailty and mortality among older men : a 26-year follow-up of the Helsinki Businessmen Study (HBS)

Personal values influence behavior and decision making, but their long-term associations with health-related quality of life (HRQoL), frailty, and mortality are less clear. We studied these associations from midlife to old age in a 26-year follow-up of the Helsinki Businessmen Study (HBS) cohort. In 1974, 1320 clinically healthy men (born 1919-1934) reported in a 12-item questionnaire their personal values. In 2000, a mailed questionnaire, including assessment of HRQoL with RAND-36 (SF-36) instrument, was sent to survivors, and 1025 men responded. In 2000, the presence of phenotypic frailty was assessed using modified Fried criteria including indicators of shrinking, physical weakness, exhaustion, and physical inactivity. Mortality through December 31, 2000 was verified from national registries. Using a factor analysis, the data of the 12-item questionnaire of personal values were loaded in 3 factors: valuing health ("Health"), enjoyable and varying life ("Enjoyment"), and comfort and work-oriented life ("Work-life-balance"). Adjusted for age, we found a significant positive association between valuing "Health" in midlife and RAND-36 domains of Physical functioning (p = .032) and Vitality (p = .005) in old age. "Health" also predicted less frailty (p = .008), and "Enjoyment" was associated with higher mortality (p = .017). Value priorities of men assessed in midlife had long-term associations with HRQoL and frailty in old age, and they may also predict mortality.Peer reviewe

Fourteen-Year Trends in the Use of Psychotropic Medications, Opioids, and Other Sedatives Among Institutionalized Older People in Helsinki, Finland

Objectives: The use of psychotropic drugs in long-term care (LTC) is very common, despite their known adverse effects. The prevalence of opioid use is growing among older adults. This study aimed to investigate trends in the prevalence of psychotropics, opioids, and sedative load in a LTC setting over a 14-year period. We also explored the interaction of psychotropic and opioid use according to residents' dementia status in nursing home (NH) and assisted living facility (ALF) settings. Design: Four cross-sectional studies. Setting: Institutional settings in Helsinki, Finland. Participants: Older residents in NHs in 2003 (n = 1987), 2011 (n = 1576), and 2017 (n = 791) and in ALFs in 2007 (n = 1377), 2011 (n = 1586), and 2017 (n = 1624). Measures: Comparable assessments were conducted among LTC residents at 4 time points over 14 years. The prevalence of regular psychotropics, opioids, and other sedatives and data on demographics and diagnoses were collected from medical records. Results: Disabilities and severity of dementia increased in both settings over time. The prevalence of all psychotropics decreased significantly in NHs (from 81% in 2003 to 61% in 2017), whereas in ALFs there was no similar linear trend (65% in 2007 and 64% in 2017). There was a significant increase in the prevalence of opioids in both settings (30% in NHs and 22% in AFLs in 2017). Residents with dementia used less psychotropics and opioids than those without dementia in both settings and at each time point. Conclusions/Implications: NHs show a favorable trend in psychotropic drug use, but the rates of psychotropic use remain high in both NHs and ALFs. In addition, the rates of opioid use have almost tripled, leading to a high sedative load among LTC residents. Clinicians should carefully consider the risk-to-benefit ratio when prescribing in LTC. (C) 2018 AMDA - The Society for Post-Acute and Long-Term Care Medicine.Peer reviewe

Cooperation between geriatricians and general practitioners for improved pharmacotherapy in home-dwelling elderly people receiving polypharmacy - the COOP Study : study protocol for a cluster randomised controlled trial

Background: Polypharmacy and inappropriate drug use is associated with negative health outcomes among older people. Various interventions for improving drug treatment have been evaluated, but the majority of studies are limited by the use of surrogate outcomes or suboptimal design. Thus, the potential for clinically significant improvements from different interventions is still unclear. The main objective of this study is therefore to evaluate the effect upon patient-relevant endpoints of a cooperation between geriatricians and general practitioners on complex drug regimens in home-dwelling elderly people. Methods: This is a cluster randomised, single-blind, controlled trial where general practitioners are invited to participate with patients from their lists. The patients must be 70 years or older, use at least seven different medications and have their medications administered by the home nursing service. We plan to recruit 200 patients, with randomisation at physician level. The intervention consists of three main parts: ( 1) clinical geriatric assessment of the patient, combined with a thorough review of their medications; ( 2) a meeting between the geriatrician and general practitioner, where the two physicians combine their competence and knowledge and discuss the drug list systematically; ( 3) clinical follow-up, depending on the medication changes that have been done. The study period is 24 weeks, and the patients are assessed at baseline, 16 and 24 weeks. The primary outcome measure is health-related quality of life according to the 15D instrument. Secondary outcome measures include physical and cognitive functioning, medication appropriateness, falls, carer burden, use of health services ( hospital or nursing home admissions, use of home nursing services) and mortality. Discussion: Our choice of patient-relevant outcome measures will hopefully provide new knowledge on the potential for clinical improvements after performing comprehensive medication reviews in home-dwelling elderly people receiving polypharmacy.Peer reviewe

Higher Polyunsaturated Fatty Acid to Saturated Fatty Acid Ratio Is Associated With Cognition, Mobility, Nutrient Intakes, and Higher Diet Quality in Heterogeneous Older Populations

Non peer reviewe

Bioimpedance analysis and physical functioning as mortality indicators among older sarcopenic people

Objectives: To assess the prognostic significance of various characteristics and measurements of sarcopenia and physical functioning on all-cause mortality among home-dwelling older people with or at-risk of sarcopenia. Design: Cross-sectional and longitudinal analyses. Setting: Porvoo sarcopenia trial in open care. Participants: Community-dwelling people aged 75 and older (N = 428, of which 182 were re-examined at one year) with four years of follow-up. Measurements: Body mass index (BMI), physical functioning (physical component of the RAND-36) and physical performance tests (Short Physical Performance Battery (SPPB)), hand grip strength, walking speed, Charlson Comorbity Index, bioimpedance-based surrogates for muscle mass: Single Frequency Skeletal Muscle Index (SF-SMI), and Calf Intracellular Resistance Skeletal Muscle Index (CRi-SMI). Date of death was retrieved from central registers. Survival analyses were performed using Life-Table analyses and Cox models. Results: Most test variables (except BMI) were associated with four-year mortality in a dose-dependent fashion. After controlling for age, gender and co-morbidity, physical performance and functioning (both SPPB and RAND36), muscle strength (hand grip strength) and CRi-SMI appeared to be independent mortality risk indicators (p <0.001) whereas SF-SMI was not. When CRi-SMI values were grouped by gender-specific cut-off points, the probability of surviving for four years decreased by 66% among the older people with low CRi-SMI (HR = 0.34, 95%CI 0.15-0.78, p = 0.011). When low CRi-SMI was further controlled for SPPB, the prognostic significance remained significant (HR = 0.55, 95%CI 0.33-0.92, p = 0.021). After controlling for age, gender, comorbidity, and CRi-SMI, the physical component of the RAND-36 (p = 0.007), SPPB (p <0,001) and hand grip strength (p = 0.009) remained significant mortality predictors. Twelve-month changes were similarly associated with allcause mortality during the follow-up period. Conclusion: CRi-SMI, muscle strength, physical performance and physical functioning are each strong independent predictors of all-cause mortality among home-dwelling older people. Compared to these indicators, BMI seemed to be clearly inferior. Of two bioimpedance-based muscle indices, CRi SMI was better predictor of mortality than SF-SMI. In this regard, muscle mass, muscle strength and physical performance are all suitable targets for the prevention of sarcopenia-related over-mortality.Peer reviewe

High Intake of Nonmilk Extrinsic Sugars Is Associated With Protein and Micronutrient Dilution in Home-Dwelling and Institutionalized Older People

Background: High dietary sugar intake may compromise protein and micronutrient intakes in people with low energy intakes. The results of micronutrient dilution studies in older people have been few and conflicting. We examined the nutritional status and nutrient intakes associated with nonmilk extrinsic sugars (NMES) intakes in older people representing a broad spectrum of both healthy and vulnerable older populations. Design and participants: This cross-sectional study combined five Finnish data sets covering homedwelling (n = 526) and institutionalized (n = 374) older people. Their nutritional status was assessed using Mini Nutritional Assessment (MNA) and nutrient intakes retrieved from 1- to 3-day food records. The participants were divided into quartiles corresponding to the proportions of energy received from NMES. Energy, nutrient, and fiber intakes were classified according to the NMES quartiles, and the participants were divided according to their places of residence (home, institution). Results: High NMES intakes were associated with older age, female sex, poor cognition, low MNA scores, immobility, and institutionalization. In all, 90% of the participants in the highest NMES quartile (Q4) were institutionalized. In the institutionalized individuals, low protein and micronutrient intakes were observed in both those with low energy intake (Q1) and in those with very high NMES intakes (Q4). In home-dwelling individuals, the nutrient intakes tended to decline linearly with increasing NMES intakes in protein and most micronutrients. Conclusions: Institutionalized older people consumed diets high in NMES, compared with those living at home, and their low energy and high NMES intakes were associated with low protein and micronutrient intakes. (C) 2016 AMDA - The Society for Post-Acute and Long-Term Care Medicine.Peer reviewe

How Do Community-Dwelling Persons with Alzheimer Disease Fall? Falls in the FINALEX Study

Peer reviewe

Temporal Trends Over Two Decades in the Use of Anticholinergic Drugs Among Older Community-Dwelling People in Helsinki, Finland

Background Knowledge of the adverse effects of drugs with anticholinergic properties (DAPs) has increased in recent decades. However, research on the temporal trends of the clinical use of DAPs is still sparse. Objectives The aim of this study was to investigate the temporal trends of DAP use over two decades in the older community-dwelling population and to explore the medication classes contributing to the use of DAPs. Methods The study involved random samples of >= 75-year-old community-dwelling Helsinki citizens in 1999, 2009, and 2019 from the Helsinki Ageing Study. A postal questionnaire inquired about their health, functioning, and medications. The medications were categorized as DAPs according to Duran's list. In addition, we grouped DAPs into various medication groups. Results The prevalence and burden of DAPs on Duran's list showed a decreasing trend over the years. In 1999 the prevalence was 20% and the burden 0.35, in 2009 they were 22% and 0.35, respectively, and in 2019 they were 16% and 0.23, respectively. There were no differences in how the 75- and 80-year-olds used DAPs compared with those aged 85 years and older. The proportion of typical antipsychotics, benzodiazepines, hypnotics, urinary antispasmodics, and asthma/chronic obstructive pulmonary disease medications decreased, whereas the proportion of atypical antipsychotics, antidepressants, strong opioids, and antihistamines increased. In particular the use of mirtazapine increased-to 3.9% in 2019. In 2019 the three most prevalent groups of DAPs were antidepressants (7.4%), opioids (2.7%), and antihistamines (2.4%). Conclusions The decrease in the use of DAPs on Duran's list is a welcome change. Although the use of old, strong DAPs has decreased, new DAPs have simultaneously emerged. Physicians need continuous education in prescribing DAPs and more recent information on the use and effects of DAPs is needed in order to decrease their exposure among the rapidly growing older population.Peer reviewe