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.

Association of eating motives with anthropometry, body composition, and dietary intake in healthy German adults.

Effective policies to address poor food choices and dietary patterns need to consider the complex set of motives affecting eating behavior. This study examined how different eating motives are associated with anthropometry, body composition, and dietary intake. Our analysis is based on a cross-sectional sample with 429 healthy adults in three different age groups collected in Germany from 2016 to 2018. Dietary intake, Body Mass Index (BMI), waist circumference (WC), and fat-free mass (FFM) were measured by standardized methods. Eating motives were measured using The Eating Motivation Scale (TEMS). Regressing dietary intakes and anthropometric indicators on TEMS motives, we identify the main sources of variation in diet and nutritional status separately for men and women. Results indicated the Health motive to be positively associated with FFM (B±SE=1.72±0.44) and negatively with WC (B±SE=-3.23±0.81) for men. For women, the Need & Hunger motive was positively associated with FFM (B±SE=1.63±0.44) and negatively with WC (B±SE=-2.46±0.81). While Liking and Habits were the most frequently stated eating motives, we did not find them to be significantly related to the nutritional status. Other motives were associated with dietary intake but not anthropometry or body composition. The Price motive was positively and the Convenience motive was negatively associated with energy (B±SE=63.77±19.98;B±SE=-46.96±17.12) and carbohydrate intake (B±SE=7.15±2.65;B±SE=-5.98±2.27) for men. The results highlight the need for more differentiated analyses of eating motives, beyond comparing the relative importance of motives based on mean values, towards the association of motives with dietary intake and nutritional status.

Critical outcomes to be included in the Core Outcome Set for nutritional intervention studies in older adults with malnutrition or at risk of malnutrition: a modified Delphi Study.

INTRODUCTION: As part of the development of an agreed minimum set of outcomes or Core Outcome Set (COS) for future nutritional intervention trials in older adults with malnutrition or at risk of malnutrition, this work reports on the Delphi surveys and final consensus. METHODS: Outcomes from a scoping review were incorporated into a two-round Delphi survey. Researchers and healthcare professionals experienced in malnutrition in older adults were invited to take part in an online survey to rate 38 selected outcomes on a nine-point Likert scale ranging from 'not important' to 'critical' for their setting (community, hospital, or long-term care). Consensus for inclusion was reached when ≥75% (or ≥60% if a patient-reported outcome) of the participants scored the outcome as 'critical' and <15% as 'not important'. Resulting outcomes were voted for inclusion or exclusion in the COS in a final online consensus meeting. RESULTS: Ninety-three and 72 participants from diverse professional backgrounds and countries participated in the 1st and 2nd Delphi round, respectively. After both rounds eleven outcomes met the inclusion criteria, largely irrespective of setting. Fifteen participants, representing academia, health care, health policy, industry, and PPI, voted in a final online consensus meeting resulting in ten outcomes: malnutrition status, dietary intake, appetite, body weight or BMI, muscle strength, muscle mass, functional performance, functional limitations, quality of life, and acceptability of the intervention. CONCLUSIONS: Ten outcomes will form the COS which is intended to be used by the scientific community in all future nutritional intervention studies for older adults with malnutrition or at risk of malnutrition. The subsequent phase will establish the appropriate methods to measure these outcomes.

Characteristics of older cyclists with self-perceived needs for improvement in cycling competence: SiFAr trial.

BACKGROUND: Older cyclists are in great risk of being injured or killed in a traffic-related accident and their needs should find more consideration in safety guidelines, urban planning, and future intervention programs. OBJECTIVE: The aim for this cross-sectional analysis was to comprehensively explore characteristics of community-dwelling cyclists aged 65 years and older with a self-perceived need to increase cycle competence. METHODS: 118 older adults (mean age 73.3 ± 5.2 years, 61% women) performed a standardized cycle course representing specific cycling skills. Additionally, health and functional assessments were carried out and characteristics regarding demographic, health, falls, bicycle equipment/type and cycling biography/behavior were obtained. RESULTS: The majority (67.8%) of this community-dwelling adults reported being unsafe when cycling and 41.3% had a bicycle fall in the past year. More than half of the participants showed at least one limitation in each of the measured cycling skills. Women significantly had more frequent limitations in four of the cycling skills measured (p ≤ 0.001) compared to men. While no significant differences were found for falls, health and functional characteristics, women and men differed significantly in terms of bicycle type, equipment, and perceived safety (p < 0.001). CONCLUSION: Limitations in cycling should be compensated by preventive bicycle training and a safe cycling infrastructure. Bicycle fit, the wearing of bicycle helmets and promotion of a sense of security while cycling can further reduce accident risk and must find recognition in safety guidelines. In addition, educational initiatives have to dismantle gender-related bicycle stereotypes.

Validation of the German version of the Protein Screener 55.

BACKGROUND/OBJECTIVES: The Protein Screener 55 + (Pro55 + ) is a brief food questionnaire to screen older community-dwelling adults for low protein intake. The result is the predicted probability of protein intake <1.0 g/kg adjusted body weight (aBW)/d ranging from 0-1. For purposes of cross-cultural validation, we translated the Pro55+ into German and tested its discriminative accuracy in detecting low protein intake of older community-dwelling people in Germany. SUBJECTS/METHODS: After translation and pilot-testing, the Pro55+ and the reference standard (3-day dietary record) were completed by 144 participants (81.6 ± 3.9 years, 61.8% female). Discriminative properties were tested by receiver operating characteristic curves and by calculating sensitivity and specificity for different cut-offs of predicted probability (>0.3/>0.5/>0.7) using <1.0 or <0.8 g/kg aBW/d to define low protein intake. RESULTS: Protein intake was <1.0 g/kg aBW/d in 39.6% of the sample and <0.8 g/kg aBW/d in 17.4%. Area under the curve was 62.0% (95%CI 52.6-71.5) and 68.8% (58.1-79.4), respectively. Specificity was 82-90% using probability cut-offs of 0.5 and 0.7 for both protein thresholds. Sensitivity was poor for protein threshold of 1.0 g/kg aBW/d regardless of the used probability cut-offs. For protein threshold of <0.8 g/kg aBW/d, sensitivity was 88.0% (71.8-96.9) using a probability cut-off of 0.09. CONCLUSION: The overall discriminative accuracy of the German Pro55+ to identify older community-dwelling people with low protein intake was poor. However, applying different probability cut-offs allows increasing specificity and sensitivity for 0.8 g/kg aBW/d to levels justifying the use for certain purposes e.g. excluding individuals with adequate protein intake. Further validation is needed.