A Core Outcome Set for nutritional intervention studies in older adults with malnutrition and those at risk: a study protocol

BACKGROUND: Malnutrition (i.e., protein-energy malnutrition) in older adults has severe negative clinical consequences, emphasizing the need for effective treatments. Many, often small, randomized controlled trials (RCTs) testing the effectiveness of nutritional interventions for the treatment of malnutrition showed mixed results and a need for meta-analyses and data pooling has been expressed. However, evidence synthesis is hampered by the wide variety of outcomes and their method of assessment in previous RCTs. This paper describes the protocol for developing a Core Outcome Set (COS) for nutritional intervention studies in older adults with malnutrition and those at risk. METHODS: The project consists of five phases. The first phase consists of a scoping review to identify frequently used outcomes in published RCTs and select additional patient-reported outcomes. The second phase includes a modified Delphi Survey involving experienced researchers and health care professionals working in the field of malnutrition in older adults, followed by the third phase consisting of a consensus meeting to discuss and agree what critical outcomes need to be included in the COS. The fourth phase will determine how each COS outcome should be measured based on a systematic literature review and a second consensus meeting. This will be followed by a dissemination and implementation phase. Patient and Public Involvement (PPI) representatives will contribute to study design, oversight, consensus, and dissemination. CONCLUSIONS: The result of this project is a COS that should be included in any RCT evaluating the effect of nutritional interventions in older adults with malnutrition and those at risk. This COS will facilitate comparison of RCT results, will increase efficient use of research resources and will reduce bias due to measurement of the outcome and publication bias. Ultimately, the COS will support clinical decision making by identifying the most effective approaches for treating and preventing malnutrition in older adults

Physical activity and exercise in dementia : an umbrella review of intervention and observational studies

Background: Dementia is a common condition in older people. Among the potential risk factors, increasing attention has been focused on sedentary behaviour. However, synthesizing literature exploring whether physical activity/exercise can affect health outcomes in people with dementia or with mild cognitive impairment (MCI) is still limited. Therefore, the aim of this umbrella review, promoted by the European Geriatric Medicine Society (EuGMS), is to understand the importance of physical activity/exercise for improving cognitive and non-cognitive outcomes in people with dementia/MCI. Methods: Umbrella review of systematic reviews (SR) (with or without meta-analyses) of randomized controlled trials (RCTs) and observational (prospective and case-control in people with MCI) studies based on a systematic literature search in several databases. The certainty of evidence of statistically significant outcomes attributable to physical activity/exercise interventions was evaluated using Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results: Among 1,160 articles initially evaluated, 27 systematic reviews (4 without meta-analysis) for a total of 28,205 participants with dementia/MCI were included. No observational study on physical activity/exercise in MCI for preventing dementia was included. In SRs with MAs, physical activity/exercise was effective in improving global cognition in Alzheimer’s disease and in all types of dementia (very low/low certainty of evidence). Moreover, physical activity/ exercise significantly improved global cognition, attention, executive function, and memory in MCI, with a certainty of evidence varying from low to moderate. Finally, physical activity/exercise improved non-cognitive outcomes in people with dementia including falls and neuropsychiatric symptoms. SRs, without meta-analysis, corroborated these results. Conclusions: Supported by very low to moderate certainty of evidence, physical activity/exercise has a positive effect on several cognitive and non-cognitive outcomes in people with dementia and MCI, but RCTs, with low risk of bias/confounding, are still needed to confirm these findings

A proposal for the retrospective identification and categorization of older people with functional impairments in scientific studies : recommendations of the Medication and Quality of Life in Frail Older Persons (MedQoL) research group

When treating older adults, a main factor to consider is physical frailty. Because specific assessments in clinical trials are frequently lacking, critical appraisal of treatment evidence with respect to functional status is challenging. Our aim was to identify and categorize assessments for functional status given in clinical trials in older adults to allow for a retrospective characterization and indirect comparison of treatment evidence from these cohorts. We conducted 4 separate systematic reviews of randomized and nonrandomized controlled clinical trials in older people with hypertension, diabetes, depression, and dementia. All assessments identified that reflected functional status were analyzed. Assessments were categorized across 4 different functional status levels. These levels span from functionally not impaired, slightly impaired, significantly impaired, to severely impaired/disabled. If available from the literature, cut-offs for these 4 functioning levels were extracted. If not, or if the existing cut-offs did not match the predefined functional levels, cut-off points were defined by an expert group composed of geriatricians, pharmacists, pharmacologists, neurologists, psychiatrists, and epidemiologists using a patient-centered approach. We identified 51 instruments that included measures of functional status. Although some of the assessments had clearly defined cut-offs across our predefined categories, many others did not. In most cases, no cut-offs existed for slightly impaired or severely impaired older adults. Missing cut-offs or values to adjust were determined by the expert group and are presented as described. The functional status assessments that were identified and operationalized across 4 functional levels could now be used for a retrospective characterization of functional status in randomized controlled trials and observational studies. Allocated categories only serve as approximations and should be validated head-to-head in future studies. Moreover, as general standard, upcoming studies involving older adults should include and explicitly report functional impairment as a baseline characteristic of all participants enrolled

Effective SLOPE: EffectS of Lifestyle interventions in Older PEople with obesity: a systematic review and network meta-analysis protocol

Introduction Obesity is highly prevalent in older adults aged 65 years or older. Different lifestyle interventions (diet, exercise, self-management) are available but benefits and harms have not been fully quantified comparing all available health promotion interventions. Special consideration must be given to functional outcomes and possible adverse effects (loss of muscle and bone mass, hypoglycaemia) of weight loss interventions in this age group. The objective of this study is to synthesise the evidence regarding the effects of different types and modalities of lifestyle interventions, or their combinations, on physical function and obesity-related outcomes such as body composition in older adults with obesity. Methods and analyses Six databases (Medline, Embase, Cochrane Central Register of Controlled Trials, Cumulated Index to Nursing and Allied Health Literature (CINAHL), Psychinfo and Web of Science) and two trial registries (Clinicaltrials.gov and the WHO International Clinical Trials Registry Platform) will be searched for randomised controlled trials of lifestyle interventions in older adults with obesity. Screening (title/abstract and full-text) and data extraction of references as well as assessment of risk of bias and rating of the certainty of evidence (Grading of Recommendations, Assessment, Development and Evaluation for network meta-analyses) will be performed by two reviewers independently. Frequentist random-effects network meta-analyses will be conducted to determine the pooled effects from each intervention. Ethics and dissemination We will submit our findings to peer-reviewed journals and present at national and international conferences as well as in scientific medical societies. Patient-targeted dissemination will involve local and national advocate groups. PROSPERO registration number CRD42019147286

Effekte von Lebensstilinterventionen auf Funktionalität und fettfreie Masse bei älteren Menschen mit Adipositas – eine systematische Übersichtsarbeit mit Netzwerkmetaanalysen

Bei älteren Personen mit Adipositas erhalten multimodale Lebensstilinterventionen die FFM und verbessern die körperliche Funktion, was für den Erhalt der Selbständigkeit einen besonderen Beitrag leisten kann

Adherence to Treatment Recommendations in Chronic Disease: What is (im)Possible? Expert conclusions from the 30th ECOG workshop 2021 Abstracts

Obesity is a chronic disease, in which treatment outcomes are highly dependent on patient and family adherence to behavioural recommendations. The role of healthy eating, physical activity, medication adherence as well as adherence to pre- and post-bariatric surgery protocols are of utmost importance for long-term treatment outcomes. Even the best interventions are not likely to reach their maximum benefit without significant levels of adherence on the part of the individual and family. Traditionally, the annual meeting of the European Childhood Obesity Group (ECOG) includes an expert workshop addressing one specific topic within the field of childhood obesity. During the 30th annual meeting, hosted by the University of Pécs, Hungary, as a virtual meeting, "adherence to treatment recommendations in obesity as a chronic disease" was addressed. The discussions that developed during the workshop are summarized in the following article

Evidence gap on antihyperglycemic pharmacotherapy in frail older adults : A systematic review.

BACKGROUND Although antihyperglycemic pharmacotherapy in frail older adults with type 2 diabetes mellitus (T2DM) is challenging, recommendations from international guidelines are mainly based on indirect evidence from trials not including frail participants. OBJECTIVE This systematic review investigated the effectiveness and safety of pharmacotherapy in frail older adults with T2DM. MATERIAL AND METHODS Randomized (RCT) and non-randomized prospective clinical trials (non-RCT) were searched in three electronic databases (Medline, Embase, Central) up to October 2018. Trials in older adults with T2DM who were assessed as significantly or severely impaired by defined cut-off scores of assessment instruments on frailty, activities of daily living or physical functional impairment were included. RESULTS Two reviewers independently screened 17,391 references for inclusion and assessed risk of bias with ROBINS‑I. Five non-RCTs and no RCT were identified. Treatment of T2DM without insulin compared to insulin could be associated with increased improvement in cardiac functions in patients with cardiac resynchronization therapy and with decreased falls in frail older women. While better glycemic control with low variability and low HbA1c (hemoglobin A1c) values (<7%) was associated with better maintenance of physical function in community-dwelling older persons, higher HbA1c values (8-8.9%) were associated with a reduction in the composite outcome of death or functional decline in community-dwelling diabetic older adults with need for skilled assistance. Due to serious risk of bias in all studies, results should be considered with caution. CONCLUSION Well-designed, large-scale RCTs including this important group of patients are required to assess the effectiveness and safety of pharmacotherapy and HbA1c targets

Reasons for and against Nutritional Interventions. An Exploration in the Nursing Home Setting

Malnutrition (MN) is widespread in nursing homes. Sometimes, but not always, nutritional interventions (NIs) are made, and the reasons for or against NIs are unknown. The aim of this cross-sectional study was to describe these reasons for residents with and without MN according to nurses’ subjective judgement and according to objective signs of MN. The nutritional status of 246 nursing home residents was subjectively judged by nurses (MN, at risk of MN, no MN) and objectively assessed by body mass index (BMI), weight loss (WL), and low food intake. NIs (enriched meals and/or oral nutritional supplements) were recorded using a standardized questionnaire, and nurses’ main reasons for (not) giving NIs were obtained in an open question. Of the residents, 11.0% were subjectively malnourished, and 25.6% were at risk of MN; 32.9% were malnourished according to objective criteria. Overall, 29.7% of the residents received NIs, 70.4% of those with MN as assessed by the nurses, 53.0% of those with objective MN, and 11.0% and 18.0% of non-malnourished residents, respectively. Reasons for NIs most often stated were low intake (47.9%), WL (23.3%), and low BMI (13.7%). Reasons against NIs mostly mentioned were adequate BMI (32.9%) and sufficient intake (24.3%). The lack of NIs for residents with MN was partially—but not always—explained by valid reasons. As residents without MN frequently received NIs, criteria for both MN rating and providing NIs, require closer scrutiny

Changes in lifestyle and body weight in children and adolescents during the COVID-19 pandemic: A representative survey of parents in Germany

Introduction: The public restrictions taken during the COVID-19 pandemic have substantially affected lifestyle and health behavior of children and adolescents. In Germany, little is known how these changes influenced daily life in families with children and adolescents. Methods: A cross-sectional survey was performed in April/May 2022 across Germany, similar to a survey performed in 2020. Parents (N=1,004, 20-65 years) with at least one child aged 3-17 years filled in an online questionnaire released by the Forsa Institute for Social Research and Statistical Analysis. Fifteen questions related to eating habits, dietary patterns, physical activity, media consumption, fitness, mental health, and body weight were included, and standard socioeconomic parameters were assessed. Results: Analysis of the parents’ answers indicated that there was a parental self-reported weight gain in every sixth child since the beginning of the COVID-19 pandemic. This was most obvious in children from families with lower household income and preexisting overweight. Parents also reported that lifestyle patterns had worsened: 70% reported an increase of media consumption during leisure time, 44% a decrease in daily physical activity as well as 16% the worsening of dietary habits (e.g. 27% stated to eat more cake and sweets). Children aged 10-12 years were most severely affected. Conclusion: Negative health effects related to the COVID-19 pandemic are predominantly observed in children 10-12 years of age and in children from families with low household income suggesting a worsening social disparity. Political action is urgently needed to tackle the adverse consequences of the COVID-19 pandemic on childhood lifestyle and health