Towards developing a Core Outcome Set for malnutrition intervention studies in older adults: a scoping review to identify frequently used research outcomes

Purpose: To conduct a scoping review to provide a systematic overview of outcomes used in nutritional intervention studies focused on the treatment of protein-energy malnutrition in older adults. // Methods: A systematic search of four electronic databases (Medline, EMBASE, CINAHL and Cochrane Central Register of Controlled Trials (CENTRAL) was performed to retrieve randomized controlled trials (RCTs), published until March 9, 2020, that evaluated the effect of nutritional interventions to treat protein-energy malnutrition in older adults and those at risk for malnutrition. Two authors screened titles, abstracts and full texts independently. One author extracted data that were cross-checked by another author. // Results: Sixty-three articles reporting 60 RCTs were identified. Most frequently used outcomes included body weight/body mass index (75.0% of RCTs), dietary intake (61.7%), functional limitations (48.3%), handgrip strength (46.7%), and body circumference (40.0%). The frequencies differed by setting (community, hospital and long-term care). For some outcomes there was a preferred assessment method (e.g., Barthel index for functional limitations), while for other outcomes (e.g., functional performance) a much greater variation was observed. // Conclusion: A large variation in outcomes, not only across but also within settings, was identified in nutritional intervention studies in malnourished older adults and those at risk. Furthermore, for many outcomes there was a large variation in the used assessment method. These results highlight the need for developing a Core Outcome Set for malnutrition intervention studies in older adults to facilitate future meta-analyses that may enhance our understanding on the effectiveness of treatment

a scoping review to identify frequently used research outcomes

© 2022. The Author(s).PURPOSE: To conduct a scoping review to provide a systematic overview of outcomes used in nutritional intervention studies focused on the treatment of protein-energy malnutrition in older adults. METHODS: A systematic search of four electronic databases (Medline, EMBASE, CINAHL and Cochrane Central Register of Controlled Trials (CENTRAL) was performed to retrieve randomized controlled trials (RCTs), published until March 9, 2020, that evaluated the effect of nutritional interventions to treat protein-energy malnutrition in older adults and those at risk for malnutrition. Two authors screened titles, abstracts and full texts independently. One author extracted data that were cross-checked by another author. RESULTS: Sixty-three articles reporting 60 RCTs were identified. Most frequently used outcomes included body weight/body mass index (75.0% of RCTs), dietary intake (61.7%), functional limitations (48.3%), handgrip strength (46.7%), and body circumference (40.0%). The frequencies differed by setting (community, hospital and long-term care). For some outcomes there was a preferred assessment method (e.g., Barthel index for functional limitations), while for other outcomes (e.g., functional performance) a much greater variation was observed. CONCLUSION: A large variation in outcomes, not only across but also within settings, was identified in nutritional intervention studies in malnourished older adults and those at risk. Furthermore, for many outcomes there was a large variation in the used assessment method. These results highlight the need for developing a Core Outcome Set for malnutrition intervention studies in older adults to facilitate future meta-analyses that may enhance our understanding on the effectiveness of treatment.publishersversionepub_ahead_of_prin

Pharmacological interventions for the management of children and adolescents living with obesity – An update of a Cochrane systematic review with meta-analyses

Importance: The effectiveness of anti-obesity medications for children and adolescents is unclear. Objective: To update the evidence on the benefits and harms of anti-obesity medication. Data sources: Cochrane CENTRAL, MEDLINE, ClinicalTrials.gov, WHO ICTRP (1/1/16-17/3/23). Study selection: Randomized controlled trials ≥6-months in people <19years living with obesity. Data extraction and Synthesis: Screening, data extraction, quality assessment conducted in duplicate, independently. Main Outcomes and Measures: Body Mass Index (BMI): 95th percentile BMI, adverse events, quality of life. Results: Thirty-five trials (N=4,331), follow-up: 6-24 months; age: 8.8-16.3 years; BMI: 26.2-41.7kg/m2. Moderate certainty evidence demonstrated a -1.71 (95% confidence interval [CI]: -2.27 to -1.14)-unit BMI reduction, ranging from -0.8 to -5.9 units between individual drugs with Semaglutide producing the largest reduction of -5.88 kg/m2 (95% CI: -6.99 to -4.77, N = 201). Drug type explained ~44% of heterogeneity. Low certainty evidence demonstrated reduction in 95th percentile BMI: -11.88 percentage points (95% CI: -18.43 to -5.30, N = 668). Serious adverse events and study discontinuation due to adverse events, did not differ between medications and comparators, but medication dose adjustments were higher compared to comparator (10.6% vs 1.7%; RR = 3.74 [95% CI: 1.51 to 9.26], I2 = 15%), regardless of approval status. There was a trend towards improved quality of life. Evidence gaps exist for children, psychosocial outcomes, comorbidities, and weight loss maintenance. Conclusions and Relevance: Anti-obesity medications in addition to behaviour-change, improves BMI but may require dose adjustment, with 1 in 100 adolescents experiencing a serious adverse event

Pharmacological interventions for the management of children and adolescents living with obesity - An update of a Cochrane systematic review with meta-analyses

Importance The effectiveness of anti-obesity medications for children and adolescents is unclear. Objective To update the evidence on the benefits and harms of anti-obesity medication. Data Sources Cochrane CENTRAL, MEDLINE, ClinicalTrials.gov and WHO ICTRP (1/1/16–17/3/23). Study Selection Randomized controlled trials ≥6 months in people <19 years living with obesity. Data Extraction and Synthesis Screening, data extraction and quality assessment conducted in duplicate, independently. Main Outcomes and Measures Body mass index (BMI): 95th percentile BMI, adverse events and quality of life. Results Thirty-five trials (N = 4331), follow-up: 6–24 months; age: 8.8–16.3 years; BMI: 26.2–41.7 kg/m2. Moderate certainty evidence demonstrated a −1.71 (95% confidence interval [CI]: −2.27 to −1.14)-unit BMI reduction, ranging from −0.8 to −5.9 units between individual drugs with semaglutide producing the largest reduction of −5.88 kg/m2 (95% CI: −6.99 to −4.77, N = 201). Drug type explained ~44% of heterogeneity. Low certainty evidence demonstrated reduction in 95th percentile BMI: −11.88 percentage points (95% CI: −18.43 to −5.30, N = 668). Serious adverse events and study discontinuation due to adverse events did not differ between medications and comparators, but medication dose adjustments were higher compared to comparator (10.6% vs 1.7%; RR = 3.74 [95% CI: 1.51 to 9.26], I2 = 15%), regardless of approval status. There was a trend towards improved quality of life. Evidence gaps exist for children, psychosocial outcomes, comorbidities and weight loss maintenance. Conclusions and Relevance Anti-obesity medications in addition to behaviour change improve BMI but may require dose adjustment, with 1 in 100 adolescents experiencing a serious adverse event

Demographic, clinical and antibody characteristics of patients with digital ulcers in systemic sclerosis: data from the DUO Registry

OBJECTIVES: The Digital Ulcers Outcome (DUO) Registry was designed to describe the clinical and antibody characteristics, disease course and outcomes of patients with digital ulcers associated with systemic sclerosis (SSc). METHODS: The DUO Registry is a European, prospective, multicentre, observational, registry of SSc patients with ongoing digital ulcer disease, irrespective of treatment regimen. Data collected included demographics, SSc duration, SSc subset, internal organ manifestations, autoantibodies, previous and ongoing interventions and complications related to digital ulcers. RESULTS: Up to 19 November 2010 a total of 2439 patients had enrolled into the registry. Most were classified as either limited cutaneous SSc (lcSSc; 52.2%) or diffuse cutaneous SSc (dcSSc; 36.9%). Digital ulcers developed earlier in patients with dcSSc compared with lcSSc. Almost all patients (95.7%) tested positive for antinuclear antibodies, 45.2% for anti-scleroderma-70 and 43.6% for anticentromere antibodies (ACA). The first digital ulcer in the anti-scleroderma-70-positive patient cohort occurred approximately 5 years earlier than the ACA-positive patient group. CONCLUSIONS: This study provides data from a large cohort of SSc patients with a history of digital ulcers. The early occurrence and high frequency of digital ulcer complications are especially seen in patients with dcSSc and/or anti-scleroderma-70 antibodies

Nutritional status according to the mini nutritional assessment (MNA)® as potential prognostic factor for health and treatment outcomes in patients with cancer – a systematic review

Background Patients with cancer have an increased risk of malnutrition which is associated with poor outcome. The Mini Nutritional Assessment (MNA®) is often used in older patients with cancer but its relation to outcome is not known. Methods Four databases were systematically searched for studies relating MNA-results with any reported outcome. Two reviewers screened titles/abstracts and full-texts, extracted data and rated the risk of bias (RoB) independently. Results We included 56 studies which varied widely in patient and study characteristics. In multivariable analyses, (risk of) malnutrition assessed by MNA significantly predicts a higher chance for mortality/poor overall survival (22/27 studies), shorter progression-free survival/time to progression (3/5 studies), treatment maintenance (5/8 studies) and (health-related) quality of life (2/2 studies), but not treatment toxicity/complications (1/7 studies) or functional status/decline in (1/3 studies). For other outcomes – length of hospital stay (2 studies), falls, fatigue and unplanned (hospital) admissions (1 study each) – no adjusted results were reported. RoB was rated as moderate to high. Conclusions MNA®-result predicts mortality/survival, cancer progression, treatment maintenance and (health-related) quality of life and did not predict adverse treatment outcomes and functional status/ decline in patients with cancer. For other outcomes results are less clear. The moderate to high RoB calls for studies with better control of potential confounders