A core outcome set for trials of infant-feeding interventions to prevent childhood obesity.

BACKGROUND: Standardisation of outcomes measured and reported in trials of infant-feeding interventions to prevent childhood obesity is essential to evaluate and synthesise intervention effects. The aim of this study is to develop an infant-feeding core outcome set for use in randomised trials of infant-feeding interventions, with children ≤1 year old, to prevent childhood obesity. METHODS: Core outcome set development followed four stages: (1) systematic review of outcomes reported in the extant literature; (2) meeting with national and international stakeholders to discuss and clarify identified outcomes; (3) e-Delphi study with national and international stakeholders to prioritise outcomes; (4) meeting with national and international stakeholders to reach consensus on outcomes. Stakeholders in stages 2-4 were paediatricians, general practitioners, nurses, midwives, non-clinician researchers, parents, dieticians, nutritionists, and childcare providers. RESULTS: Twenty-six outcomes were identified for inclusion in the core outcome set. These were grouped in nine outcome domains: 'breastfeeding and formula feeding', 'introduction of solids', 'parent feeding practices and styles', 'parent knowledge and beliefs', 'practical feeding', 'food environment', 'dietary intake', 'perceptions of infant behaviour and preferences', and 'child weight'. CONCLUSIONS: The core outcome set identified in this study is the minimum that should be measured and reported in trials of infant-feeding interventions to prevent childhood obesity. This standardisation of outcomes will enable more comprehensive examination and synthesis of the effects of infant-feeding interventions to prevent childhood obesity.

Developing a core outcome set for childhood obesity prevention: A systematic review.

Synthesis of effects of infant feeding interventions to prevent childhood obesity is limited by outcome measurement and reporting heterogeneity. Core outcome sets (COSs) represent standardised approaches to outcome selection and reporting. The aim of this review is to identify feeding outcomes used in infant feeding studies to inform an infant feeding COS for obesity prevention interventions. The databases EMBASE, Medline, CINAHL, CENTRAL, and PsycINFO searched from inception to February 2017. Studies eligible for inclusion must examine any infant feeding outcome in children ≤1 year. Feeding outcomes include those measured using self-report and/or observational methods and include dietary intake, parent-child interaction, and parental beliefs, among others. Data were extracted using a standardised data extraction form. Outcomes were assigned to outcome domains using an inductive, iterative process with a multidisciplinary team. We identified 82 unique outcomes, representing nine outcome domains. Outcome domains were "breast and formula feeding," "introduction of solids," "parent feeding practices and styles," "parent knowledge and beliefs," "practical feeding," "food environment," "dietary intake," "perceptions of infant behaviour and preferences," and "child weight outcomes." Heterogeneity in definition and frequency of outcomes was noted in reviewed studies. "Introduction of solids" (59.5%) and "breastfeeding duration" (55.5%) were the most frequently reported outcomes. Infant feeding studies focus predominantly on consumption of milks and solids and infant weight. Less focus is given to modifiable parental and environmental factors. An infant feeding COS can minimise heterogeneity in selection and reporting of infant feeding outcomes for childhood obesity prevention interventions.

Evaluation of cystatin C in malignancy and comparability of estimates of GFR in oncology patients.

OBJECTIVES: Creatinine is the biomarker of choice for use in estimates of kidney function in oncology patients. However as non-renal factors such as muscle mass can influence creatinine concentrations, we evaluated cystatin C as an alternative biomarker and its incorporation in GFR estimating formulae in an oncology setting. Measured GFR is infrequently undertaken in adult clinical practice with the consequent reliance on calculated GFR for patient assessment. DESIGN AND METHODS: Cystatin C and creatinine concentrations were evaluated from 134 oncology patients prior to commencing chemotherapeutic cycles. Estimates of creatinine clearance (Cockroft-Gault) and GFR (using Hoek, Jonsson, MDRD and CKD-EPI) were evaluated. Cystatin C-based GFR estimates (using CKD-EPI CysC and CKD-EPI SCr/CysC) were compared with the creatinine-based GFR estimates (CG, MDRD and CKD-EPI SCr) within the GFR ranges of 60-89, 45-59 and ≤44 mL/min/1.73 m2. RESULTS: Cystatin C concentrations were significantly higher in oncology patients both prior to commencing chemotherapy (F: P<0.01 and M: P<0.0001) and during cycles of treatment (F: P<0.0001 and M: P<0.01) when compared with a reference population. Cystatin C concentrations also increased significantly during chemotherapy (P<0.0001) in a subset of female patients evaluated. Poor agreement (average 42%) was demonstrated between CKD-EPI CysC and creatinine-based GFR estimates within the investigated GFR ranges, with improved agreement (average 55%) when using the combined CKD-EPI SCr/CysC formula. CONCLUSIONS: This study demonstrated a malignancy and treatment-mediated effect on cystatin C measures, which may confound its clinical utility in estimating GFR in oncology patients.