The use and reporting of primary and secondary outcome measures in trials evaluating childhood obesity treatment interventions

BMC Obesity - Tập 1 - Trang 1-7 - 2014
Maria Bryant1, Lee Ashton1,2, Jane Nixon1, Susan Jebb3, Judy Wright4, Katharine Roberts5, Julia Brown1
1Clinical Trials Research Unit, University of Leeds, Leeds, UK
2The University of Newcastle, Callaghan, Australia
3Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
4Institute of Health Sciences, University of Leeds, Leeds, UK
5National Obesity Observatory (NOO), Oxford, UK

Tóm tắt

Existing systematic reviews aimed at comparing effectiveness of childhood obesity treatment interventions are limited by a lack of quality in the conduct and reporting of trials in this area. This study aimed to identify the number and types of primary and secondary outcomes used within trials of childhood obesity treatments and to determine the degree to which these trials correctly report their use of outcome measures. A systematic literature review was conducted to identify phase II (i.e. pilot and feasibility studies) and phase III (e.g. determining effectiveness) trials of childhood obesity treatments across 11 databases. Data were extracted from eligible manuscripts pertaining to the number and type of outcome measures used, in addition to details of citations provided for these measures. 145 different outcome measures were reported to be used within 200 identified eligible trial manuscripts. Citations were provided to indicate the provenance for 417 measures, but only 13% of these were correctly linked to papers describing the development and/or evaluation of measures. This study identified inconsistencies and inaccuracies in the use and reporting of outcome measures used by eligible trials. Researchers in this area are urged to consider guidelines such as CONSORT and the National Obesity Observatory Standard Evaluation Framework in the design and reporting of future trials.

Tài liệu tham khảo

Oude Luttikhuis H, Baur L, Jansen H, Shrewsbury VA, O'Malley C, Stolk RP, Summerbell CD: Interventions for treating obesity in children.Cochrane Database Syst Rev 2009, Issue 1: Art No:CD001872. doi:10.1002/14651858.CD001872.pub2., Health Survey for England 2010 TNIC, Lifestyles Statistics: Statistics on obesity, physical activity and diet. The NHS Information Centre for Health and Social Care; 2012. Holloway RG, Dick AW: Clinical trial end points: on the road to nowhere?. Neurology. 2002, 58: 679-686. 10.1212/WNL.58.5.679. Sinha I, Jones L, Smyth RL, Williamson PR: A systematic review of studies that Aim to determine which outcomes to measure in clinical trials in children. PLoS Med. 2008, 5: e96-10.1371/journal.pmed.0050096. Roberts K, Cavill N, Rutter H: Standard evaluation framework for weight management interventions.National Obesity Observatory 2009, ., [http://www.noo.org.uk/core/frameworks] Bryant M, Ashton LJ, Nixon J, Wright J, Jebb SA, Katharine R, Brown J: Framework of outcome measures recommended for use in the evaluation of childhood obesity treatment interventions: The CoOR framework.Pediatric Obesity 2014. 10.1111/j.2047-6310.2014.220.x., Bryant M, Ashton LJ, Brown J, Wright J, Jebb SA, Roberts K, Nixon J: Systematic review to identify and appraise outcome measures used to evaluate childhood obesity treatment interventions: evidence of purpose, application, validity, reliability and sensitivity. HTA monograph Series. 2014, 18 (51): 2014-doi:10.3310/hta18510 Oude Luttikhuis H, Baur L, Jansen H, Shrewsbury V, O’Malley C, Stolk R, Summerbell C: Interventions for treating obesity in children (Cochrane Review). 2009, Wiley and Sons Ltd, Chichester, UK Arain M, Campbell M, Cooper C, Lancaster G: What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Meth. 2010, 10: 67-10.1186/1471-2288-10-67. Gropper SS, Acosta PB: The therapeutic effect of fiber in treating obesity. J Am Coll Nutr. 1987, 6: 533-535. 10.1080/07315724.1987.10720213. McCallum Z, Wake M, Gerner B, Baur LA, Gibbons K, Gold L, Gunn J, Harris C, Naughton G, Riess C, Sanci L, Sheehan J, Ukoumunne OC, Waters E: Outcome data from the LEAP (Live, Eat and Play) trial: a randomized controlled trial of a primary care intervention for childhood overweight/mild obesity. Int J Obes (Lond). 2007, 31: 630-636. US Department of Health and Human Services FDA: Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims.Health Qual Life Outcomes 2006, 4:. doi:10.1186/1477-7525-1184-1179., Assessing health status and quality of life instruments: attributes and review criteria. Qual Life Res. 2002, 11: 193-205. 10.1023/A:1015291021312. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T, Consort G: The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001, 134: 663-694. 10.7326/0003-4819-134-8-200104170-00012.