Abstract
Background:
Despite the large number of randomized controlled trials (RCTs) assessing weight loss interventions, no study has assessed the quality of reporting in these trials.
Purpose:
To assess the quality of reporting of RCTs of weight loss interventions and to identify predictors of reporting quality.
Methods:
The RCTs assessed were derived from a published systematic review of trials investigating the efficacy of weight loss interventions. For our study, two reviewers independently rated the quality of reporting in these trials, based on the Consolidated Standards for Reporting of Trials (CONSORT) Statement. We describe the quality of reporting using number (percent) of studies satisfying each of the 44 CONSORT criteria. We use generalized estimating equations (GEE) to fit a multivariable regression model to determine factors that are associated with the overall quality reporting score.
Results:
We assessed 63 RCTs, of which 25 were dietary-lifestyle trials, 22 were pharmacological trials and 16 were behavior-cognitive, exercise-lifestyle, or surgical trials. Less than half (46%) of the trials defined the primary outcome of the study; about 10% provided the description of the method of allocation concealment. Multivariable GEE results showed that the sample size, type of intervention (non-pharmacologic trials having lower scores than pharmacologic trials), and publication time relative to the CONSORT Statement publication in 1996 (publications after 1996 having higher scores) were strong predictors of the quality reporting score. Reporting a statistically significant result on the primary outcome was not significantly associated with the quality score.
Conclusion:
While the overall quality in reporting seemed to have improved since the publication of the revised CONSORT Statement in 1996, the reporting of some key methodologic aspects, such as clear description of primary outcome and method of allocation concealment, still requires improvements. Factors that are significantly associated with the overall quality reporting score can be used as surrogates in the review of protocols to enhance the quality of the final reports.
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References
Controlling the global obesity epidemic. WHO 09/03/2003 http://www.who.int/nut/obs.htm (Date of last access: October 6, 2006).
Douketis JD, Thabane L, Macie C, Williamson DF . Systematic review of long-term weight loss studies in obese adults: clinical significance and applicability to clinical practice. Int J Obes Relat Metabol Dis 2005; 10: 1153–1167.
Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, et al., for the CONSORT Group. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001; 134: 663–694.
US Preventive Services Task Force. Screening for obesity in adults: recommendations and rationale. Ann Intern Med 2003; 139: 930–932.
Douketis JD, Feightner JW, Attia J, Feldman WF, with the Canadian Task Force on Preventive Health Care. Periodic health examination, 1999 update: detection prevention and treatment of obesity. CMAJ 1999; 160: 513–524.
Krzyzanowska MK, Pintilie M, Brezden-Masley C, Dent R, Tannock IF . Quality of abstracts describing randomized trials in the proceedings of American Society of Clinical Oncology Meetings: guidelines for improved reporting. J Clin Oncol 2004; 22: 1993–1999.
Bath FJ, Owen VE, Bath PMW . Quality of full and final publications reporting acute stroke trials. A systematic review. Stroke 1998; 29: 2203–2210.
Mills E, Loke YK, Wu P, Montori VM, Perri D, Moher D et al. Determining the reporting quality of RCTs in clinical pharmacology. Br J Clin Pharmacol 2004; 58: 61–65.
Latronico N, Botteri M, Minelli C, Zanotti C, Bertolini G, Candiani A . Quality of reporting of randomised controlled trials in the intensive care literature. A systematic analysis of papers published in Intensive Care Medicine over 26 years. Intensive Care Med 2002; 28: 1316–1323.
Soares HP, Daniels S, Kumar A, Clarke M, Scott C, Swann S et al. Bad reporting does not mean bad methods for randomized trials: observational study of randomized controlled trials performed by the radiation therapy oncology group. BMJ 2004; 328: 22–25.
Landis JR, Koch GG . The measurement of observer agreement for categorical data. Biometrics 1977; 33: 159–174.
Hardin J, Hilbe J . Generalized Linear Models and Extensions. Stata Press: College Station, Texas, 2001.
Kline RB . Principles and Practice of Structural Equation Modeling. Guilford Press: New York, NY, 1998.
Lai R, Chu R, Fraumeni M, Thabane L . Quality of randomized controlled trials reporting in the primary treatment of brain tumors. J Clin Oncol 2006; 24: 1136–1144.
Chan AW, Altman DG . Epidemiology and reporting of randomised trials published in PubMed journals. Lancet 2005; 365: 1159–1162.
Soares HP, Daniels S, Kumar A, Clarke M, Scott C, Swann S et al. Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group. BMJ 2004; 328: 22–24.
Devereaux PJ, Choi PT, El-Dika S, Bhandari M, Montori VM, Schunemann HJ et al. An observational study found that authors of randomized controlled trials frequently use concealment of randomization and blinding, despite the failure to report these methods. J Clin Epidemiol 2004; 57: 1232–1236.
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Appendix
Appendix
Table A1 Presents CONSORT reporting criteria.
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Thabane, L., Chu, R., Cuddy, K. et al. What is the quality of reporting in weight loss intervention studies? A systematic review of randomized controlled trials. Int J Obes 31, 1554–1559 (2007). https://doi.org/10.1038/sj.ijo.0803640
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DOI: https://doi.org/10.1038/sj.ijo.0803640
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