title: Systematic review to identify and appraise outcome measures used to evaluate childhood obesity treatment interventions (CoOR): evidence of purpose, application, validity, reliability and sensitivity.
abstract: BACKGROUND
  Lack of uniformity in outcome measures used in evaluations of childhood obesity treatment interventions can impede the ability to assess effectiveness and limits comparisons across trials.
  
  
  OBJECTIVE
  To identify and appraise outcome measures to produce a framework of recommended measures for use in evaluations of childhood obesity treatment interventions.
  
  
  METHODS
  Eleven electronic databases were searched between August and December 2011, including MEDLINE; MEDLINE In-Process and Other Non-Indexed Citations; EMBASE; PsycINFO; Health Management Information Consortium (HMIC); Allied and Complementary Medicine Database (AMED); Global Health, Maternity and Infant Care (all Ovid); Cumulative Index to Nursing and Allied Health Literature (CINAHL) (EBSCOhost); Science Citation Index (SCI) [Web of Science (WoS)]; and The Cochrane Library (Wiley) - from the date of inception, with no language restrictions. This was supported by review of relevant grey literature and trial databases.
  
  
  METHODS
  Two searches were conducted to identify (1) outcome measures and corresponding citations used in published childhood obesity treatment evaluations and (2) manuscripts describing the development and/or evaluation of the outcome measures used in the childhood intervention obesity evaluations. Search 1 search strategy (review of trials) was modelled on elements of a review by Luttikhuis et al. (Oude Luttikhuis H, Baur L, Jansen H, Shrewsbury VA, O'Malley C, Stolk RP, et al. Interventions for treating obesity in children. Cochrane Database Syst Rev 2009;1:CD001872). Search 2 strategy (methodology papers) was built on Terwee et al.'s search filter (Terwee CB, Jansma EP, Riphagen II, de Vet HCW. Development of a methodological PubMed search filter for finding studies on measurement properties of measurement instruments. Qual Life Res 2009;18:1115-23). Eligible papers were appraised for quality initially by the internal project team. This was followed by an external appraisal by expert collaborators in order to agree which outcome measures should be recommended for the Childhood obesity Outcomes Review (CoOR) outcome measures framework.
  
  
  RESULTS
  Three hundred and seventy-nine manuscripts describing 180 outcome measures met eligibility criteria. Appraisal of these resulted in the recommendation of 36 measures for the CoOR outcome measures framework. Recommended primary outcome measures were body mass index (BMI) and dual-energy X-ray absorptiometry (DXA). Experts did not advocate any self-reported measures where objective measurement was possible (e.g. physical activity). Physiological outcomes hold potential to be primary outcomes, as they are indicators of cardiovascular health, but without evidence of what constitutes a minimally importance difference they have remained as secondary outcomes (although the corresponding lack of evidence for BMI and DXA is acknowledged). No preference-based quality-of-life measures were identified that would enable economic evaluation via calculation of quality-adjusted life-years. Few measures reported evaluating responsiveness.
  
  
  CONCLUSIONS
  Proposed recommended measures are fit for use as outcome measures within studies that evaluate childhood obesity treatment evaluations specifically. These may or may not be suitable for other study designs, and some excluded measures may be more suitable in other study designs.
  
  
  CONCLUSIONS
  The CoOR outcome measures framework provides clear guidance of recommended primary and secondary outcome measures. This will enhance comparability between treatment evaluations and ensure that appropriate measures are being used. Where possible, future work should focus on modification and evaluation of existing measures rather than development of tools de nova. In addition, it is recommended that a similar outcome measures framework is produced to support evaluation of adult obesity programmes.
  
  
  BACKGROUND
  The National Institute for Health Research Health Technology Assessment programme.
authors.affiliation: Clinical Trials Research Unit, University of Leeds, Leeds, UK.
authors.forename: Maria
authors.initials: M
authors.lastname: Bryant
authors.affiliation: Clinical Trials Research Unit, University of Leeds, Leeds, UK.
authors.forename: Lee
authors.initials: L
authors.lastname: Ashton
authors.affiliation: Clinical Trials Research Unit, University of Leeds, Leeds, UK.
authors.forename: Julia
authors.initials: J
authors.lastname: Brown
authors.affiliation: Medical Research Council (MRC) Human Nutrition Research, Cambridge, UK.
authors.forename: Susan
authors.initials: S
authors.lastname: Jebb
authors.affiliation: Institute of Health Sciences, University of Leeds, Leeds, UK.
authors.forename: Judy
authors.initials: J
authors.lastname: Wright
authors.affiliation: National Obesity Observatory (NOO), Oxford, UK.
authors.forename: Katharine
authors.initials: K
authors.lastname: Roberts
authors.affiliation: Clinical Trials Research Unit, University of Leeds, Leeds, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Nixon
mesh_terms: D015502:Absorptiometry, Photon; D015992:Body Mass Index; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods* / Q000592:standards*; D063766:Pediatric Obesity / Q000628:therapy*; D015203:Reproducibility of Results