Determinants of trajectories of fatigability and mobility among older medical patients during and after hospitalization; an explorative study

BACKGROUND: Fatigability is an important marker of functional decline in community dwelling older people, yet its relationship with functional decline after hospitalization is unclear. The objectives of this study were to identify trajectories of fatigability and mobility over time and to examine the association between demographic and clinical characteristics and these trajectories in medical patients aged 70 years and older admitted to a Dutch tertiary care teaching hospital. METHODS: In this prospective cohort study with baseline (in-hospital), discharge, three-, and six-months post discharge follow-up measurements, fatigability was assessed by the physical subscale of the Pittsburgh Fatigability Scale (PFS). Mobility was assessed by the De Morton Mobility Index (DEMMI). Group-based trajectory modeling was used to identify joint trajectories of fatigability and mobility. Covariates included demographic (age, sex, living situation, education) and clinical characteristics (functional status, frailty status, depression, comorbidity, length of hospital stay). RESULTS: Among 44 patients, three distinct fatigability trajectories and two mobility trajectories were identified over the course from hospital admission up to six months after discharge. Subsequently, three joint trajectories were identified, including low fatigability and high mobility (11%), improving fatigability and high mobility (52%), and high fatigability and low mobility (36%). Controlling for baseline functional status, patients with a lower comorbidity score (OR: 0.27, 95%CI 0.10; 0.74) and higher frailty status (OR: 1.36, 95%CI: 1.07; 1.74) were more likely to be a member of the high fatigability and low mobility trajectories. CONCLUSIONS: From hospital admission up to six months after discharge, three distinct trajectories of fatigability and mobility were identified among older medical patients. Our results should be interpreted with caution due to the small sample size, but may inspire other researchers to determine the value of fatigability assessment in identifying older medical patients at risk for developing mobility problems. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12877-021-02714-9

Trajectories of Self-Rated Health in an Older General Population and Their Determinants: The Lifelines Cohort Study

OBJECTIVES: Poor self-rated health (SRH) is a strong predictor of premature mortality in older adults. Trajectories of poor SRH are associated with multimorbidity and unhealthy behaviours. Whether trajectories of SRH are associated with deviating physiological markers is unclear. This study identified trajectories of SRH and investigated the associations of trajectory membership with chronic diseases, health risk behaviours and physiological markers in community-dwelling older adults. STUDY DESIGN AND SETTING: Prospective general population cohort. PARTICIPANTS: Trajectories of SRH over 5 years were identified using data of 11 600 participants aged 65 years and older of the Lifelines Cohort Study. OUTCOME MEASURES: Trajectories of SRH were the main outcome. Covariates included demographics (age, gender, education), chronic diseases, health-risk behaviour (physical activity, smoking, drinking) and physiological markers (body mass index, cardiovascular function, lung function, glucose metabolism, haematological condition, endocrine function, renal function, liver function and cognitive function). RESULTS: Four stable trajectories were identified, including excellent (n=607, 6%), good (n=2111, 19%), moderate (n=7677, 65%) and poor SRH (n=1205, 10%). Being women (OR: 1.4; 95% CI: 1.0 to 1.9), low education (OR: 2.1; 95% CI: 1.5 to 3.0), one (OR: 10.4; 95% CI: 7.4 to 14.7) or multiple chronic diseases (OR: 37.8; 95% CI: 22.4 to 71.8), smoking (OR: 1.8; 95% CI: 1.0 to 3.2), physical inactivity (OR: 3.1; 95% CI: 1.8 to 5.2), alcohol abstinence (OR: 2.2; 95% CI: 1.4 to 3.2) and deviating physiological markers (OR: 1.5; 95% CI: 1.1 to 2.0) increase the odds for a higher probability of poor SRH trajectory membership compared with excellent SRH trajectory membership. CONCLUSION: SRH of community-dwelling older adults is stable over time with the majority (65%) having moderate SRH. Older adults with higher probabilities of poor SRH often have unfavourable health status

Reproducibility and responsiveness of the Frailty Index and Frailty Phenotype in older hospitalized patients

BACKGROUND: There is growing interest for interventions aiming at preventing frailty progression or even to reverse frailty in older people, yet it is still unclear which frailty instrument is most appropriate for measuring change scores over time to determine the effectiveness of interventions. The aim of this prospective cohort study was to determine reproducibility and responsiveness properties of the Frailty Index (FI) and Frailty Phenotype (FP) in acutely hospitalized medical patients aged 70 years and older. METHODS: Reproducibility was assessed by Intra-Class Correlation Coefficients (ICC), standard error of measurement (SEM) and smallest detectable change (SDC); Responsiveness was assessed by the standardized response mean (SRM), and area under the receiver operating characteristic curve (AUC). RESULTS: At baseline, 243 patients were included with a median age of 76 years (range 70–98). The analytic samples included 192 and 187 patients in the three and twelve months follow-up analyses, respectively. ICC of the FI were 0.85 (95 % confidence interval [CI]: 0.76; 0.91) and 0.84 (95% CI: 0.77; 0.90), and 0.65 (95% CI: 0.49; 0.77) and 0.77 (95% CI: 0.65; 0.84) for the FP. SEM ranged from 5 to 13 %; SDC from 13 to 37 %. SRMs were good in patients with unchanged frailty status (< 0.50), and doubtful to good for deteriorated and improved patients (0.43–1.00). AUC’s over three months were 0.77 (95% CI: 0.69; 0.86) and 0.71 (95% CI: 0.62; 0.79) for the FI, and 0.68 (95% CI: 0.58; 0.77) and 0.65 (95% CI: 0.55; 0.74) for the FP. Over twelve months, AUCs were 0.78 (95% CI: 0.69; 0.87) and 0.82 (95% CI: 0.73; 0.90) for the FI, and 0.78 (95% CI: 0.69; 0.87) and 0.75 (95% CI: 0.67; 0.84) for the FP. CONCLUSIONS: The Frailty Index showed better reproducibility and responsiveness properties compared to the Frailty Phenotype among acutely hospitalized older patients. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12877-021-02444-y

Supporting older patients in making healthcare decisions: The effectiveness of decision aids; A systematic review and meta-analysis

Objective: To systematically review randomized controlled trials and clinical controlled trials evaluating the effectiveness of Decision Aids (DAs) compared to usual care or alternative interventions for older patients facing treatment, screening, or care decisions.Methods: A systematic search of several databases was conducted. Eligible studies included patients ≥ 65 years or reported a mean of ≥ 70 years. Primary outcomes were attributes of the choice made and decision making process, user experience and ways in which DAs were tailored to older patients. Meta-analysis was conducted, if possible, or outcomes were synthesized descriptively.Results: Overall, 15 studies were included. Using DAs were effective in increasing knowledge (SMD 0.90; 95% CI [0.48, 1.32]), decreasing decisional conflict (SMD −0.15; 95% CI [−0.29, −0.01]), improving patient-provider communication (RR 1.67; 95% CI [1.21, 2.29]), and preparing patients to make an individualized decision (MD 35.7%; 95% CI [26.8, 44.6]). Nine studies provided details on how the DA was tailored to older patients.Conclusion: This review shows a number of favourable results for the effectiveness of DAs in decision making with older patients.Practice implications: Current DAs can be used to support shared decision making with older patients when faced with treatment, screening or care decisions

Acetaminophen for self-reported sleep problems in an elderly population (ASLEEP): Study protocol of a randomized placebo-controlled double-blind trial

Background: The prevalence of sleep disorders increases with age. Sleep disorders may have serious health implications and may be related to serious underlying diseases. Many older people use hypnotics, like benzodiazepines, although these medications have serious side effects and often lead to habituation. Acetaminophen is one of the most frequently used off-label drugs for sleep disorders, although little is known about its effects. Our objective is to investigate whether acetaminophen is effective in treating self-reported sleep disorders in older people. Methods/Design: Participants, aged 65 years or older (n = 150), who have sleep disorders will be randomized for treatment with either acetaminophen 1000 mg or placebo, once daily at bedtime in a double-blind design. Eligible patients should be able to give informed consent, should not be cognitively impaired (Minimal Mental State Examination (MMSE) score ≥ 20), should not have pain, and should not use acetaminophen on a regular basis because of pain complaints. The study will take three weeks to complete. During these three weeks, the participants register their sleep behavior in a sleep diary. The participants will use the study medication during the second and third week. The primary endpoint will be the self-reported sleep disorders at the end of week three, as measured by means of the Insomnia Severity Index (ISI). To validate these subjective sleep parameters against objectively measured indices of the sleep-wake pattern, we will measure the periods of wakefulness and sleep in a subgroup of participants, using an actigraph worn on the wrist during the entire study period. Discussion: The proposed study will contribute to our knowledge about the treatment of sleep disorders in an older population. There is a need for treatments for sleep disorders without serious adverse effects. Acetaminophen might be a simple and inexpensive alternative for the regimes that are currently used with older people. Trial registration: The Netherlands National Trial Register NTR2747

Study protocol: a randomised controlled trial on the clinical effects of levothyroxine treatment for subclinical hypothyroidism in people aged 80 years and over

Background: Subclinical hypothyroidism is common in older people and its contribution to health and disease needs to be elucidated further. Observational and clinical trial data on the clinical effects of subclinical hypothyroidism in persons aged 80 years and over is inconclusive, with some studies suggesting harm and some suggesting benefits, translating into equipoise whether levothyroxine therapy provides clinical benefits. This manuscript describes the study protocol for the Institute for Evidence-Based Medicine in Old Age (IEMO) 80-plus thyroid trial to generate the necessary evidence base. Methods: The IEMO 80-plus thyroid trial was explicitly designed as an ancillary experiment to the Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism randomised placebo controlled Trial (TRUST) with a near identical protocol and shared research infrastructure. Outcomes will be presented separately for the IEMO and TRUST 80-plus groups, as well as a pre-planned combined analysis of the 145 participants included in the IEMO trial and the 146 participants from the TRUST thyroid trial aged 80 years and over. The IEMO 80-plus thyroid trial is a multi-centre randomised double-blind placebo-controlled parallel group trial of levothyroxine treatment in community-dwelling participants aged 80 years and over with persistent subclinical hypothyroidism (TSH ≥4.6 and ≤ 19.9 mU/L and fT4 within laboratory reference ranges). Participants are randomised to levothyroxine 25 or 50 micrograms daily or matching placebo with dose titrations according to TSH levels, for a minimum follow-up of one and a maximum of three years. Primary study endpoints: hypothyroid physical symptoms and tiredness on the thyroid-related quality of life patient-reported outcome (ThyPRO) at one year. Secondary endpoints: generic quality of life, executive cognitive function, handgrip strength, functional ability, blood pressure, weight, body mass index, and mortality. Adverse events will be recorded with specific interest on cardiovascular endpoints such as atrial fibrillation and heart failure. Discussion: The combined analysis of participants in the IEMO 80-plus thyroid trial with the participants aged over 80 in the TRUST trial will provide the largest experimental evidence base on multimodal effects of levothyroxine treatment in 80-plus persons to date

Frailty and treatment decisions in older patients with vulvar cancer: a single-center cohort study

Introduction: Vulvar cancer is a disease that mainly affects older women. Frailty is an important predictor of outcomes and geriatric assessment can help tailor treatment decisions and improve outcomes. This study aims to assess the prevalence of frailty in older women with vulvar cancer, and how it relates to integrated geriatric care and treatment according to the oncological guidelines. Materials and Methods: A single-center cohort study was performed, among patients 70 years and older, who were diagnosed with vulvar cancer at Leiden University Medical Center, between January 2012 and May 2020. Data on geriatric assessment, treatment decision-making and treatment-related outcomes were collected. Results: Our study included 114 patients. Mean age was 79.7 years, and 52 patients (45.6%) were frail. Of the frail patients, 42.0% were referred to a geriatrician. In eight of these cases, the geriatrician was actively involved in weighing the benefit and harm of standard oncological treatment versus de-escalated treatment. Frailty, higher age, impairment in the somatic domain, cognitive impairment, and functional dependency were associated with referral to a geriatrician and with active involvement of a geriatrician in decision making. In 26 of frail patients (50.0%) oncological treatment was de-escalated. Frailty, higher age, impairment in the somatic domain, cognitive impairment, and functional dependency were associated with de-escalation of treatment. De-escalated treatment did not compromise survival. Discussion: Frailty is prevalent among older women with vulvar cancer and is associated with referral to a geriatrician and de-escalation of oncological treatment. While this reflects that it is deemed important to tailor treatment decision for frail patients, most frail patients are not routinely evaluated by a geriatrician. Further multidisciplinary collaboration and research is necessary to optimize tailored treatment decisions for this patient group.Metabolic health: pathophysiological trajectories and therap

Rationale and design of the OPTIMIZE trial: OPen label multicenter randomized trial comparing standard IMmunosuppression with tacrolimus and mycophenolate mofetil with a low exposure tacrolimus regimen In combination with everolimus in de novo renal transplantation in Elderly patients

BackgroundIn 2019, more than 30% of all newly transplanted kidney transplant recipients in The Netherlands were above 65 years of age. Elderly patients are less prone to rejection, and death censored graft loss is less frequent compared to younger recipients. Elderly recipients do have increased rates of malignancy and infection-related mortality. Poor kidney transplant function in elderly recipients may be related to both pre-existing (i.e. donor-derived) kidney damage and increased susceptibility to nephrotoxicity of calcineurin inhibitors (CNIs) in kidneys from older donors. Hence, it is pivotal to shift the focus from prevention of rejection to preservation of graft function and prevention of over-immunosuppression in the elderly. The OPTIMIZE study will test the hypothesis that reduced CNI exposure in combination with everolimus will lead to better kidney transplant function, a reduced incidence of complications and improved health-related quality of life for kidney transplant recipients aged 65 years and older, compared to standard immunosuppression.MethodsThis open label, randomized, multicenter clinical trial will include 374 elderly kidney transplant recipients (>= 65 years) and consists of two strata. Stratum A includes elderly recipients of a kidney from an elderly deceased donor and stratum B includes elderly recipients of a kidney from a living donor or from a deceased donor= 45 ml/min per 1.73 m(2) in stratum B, after 2 years, respectively.ConclusionsThe OPTIMIZE study will help to determine the optimal immunosuppressive regimen after kidney transplantation for elderly patients and the cost-effectiveness of this regimen. It will also provide deeper insight into immunosenescence and both subjective and objective outcomes after kidney transplantation in elderly recipients.Trial registrationClinicalTrials.gov: NCT03797196, registered January 9th, 2019. EudraCT: 2018-003194-10, registered March 19th, 2019.Nephrolog