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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 doi: https://doi.org/10.1136/bmj.328.7430.22 (Published 01 January 2004) Cite this as: BMJ 2004;328:22
  1. Heloisa P Soares, research assistant1,
  2. Stephanie Daniels, coordinator, Eastern Cooperative Oncology Group2,
  3. Ambuj Kumar, research associate1,
  4. Mike Clarke, director3,
  5. Charles Scott, senior director4,
  6. Suzanne Swann, senior biostatistician4,
  7. Benjamin Djulbegovic (djulbebm{at}moffitt.usf.edu), professor of oncology and medicine1
  1. 1Department of Interdisciplinary Oncology, H Lee Moffitt Cancer Center and Research Institute, University of South Florida, 12902 Magnolia Drive, Tampa, FL 33612, USA
  2. 2H Lee Moffitt Cancer Center and Research Institute
  3. 3UK Cochrane Centre, Oxford OX2 7LG
  4. 4Statistical Unit, Radiation Therapy Oncology Group, PA 19107, USA
  1. Correspondence to: B Djulbegovic
  • Accepted 10 October 2003

Abstract

Objective To determine whether poor reporting of methods in randomised controlled trials reflects on poor methods.

Design Observational study.

Setting Reports of randomised controlled trials conducted by the Radiation Therapy Oncology Group since its establishment in 1968.

Participants The Radiation Therapy Oncology Group.

Outcome measures Content of reports compared with the design features described in the protocols for all randomised controlled trials.

Results The methodological quality of 56 randomised controlled trials was better than reported. Adequate allocation concealment was achieved in all trials but reported in only 42% of papers. An intention to treat analysis was done in 83% of trials but reported in only 69% of papers. The sample size calculation was performed in 76% of the studies, but reported in only 16% of papers. End points were clearly defined and α and βerrors were prespecified in 76% and 74% of the trials, respectively, but only reported in 10% of the papers. The one exception was the description of drop outs, where the frequency of reporting was similar to that contained in the original statistical files of the Radiation Therapy Oncology Group.

Conclusions The reporting of methodological aspects of randomised controlled trials does not necessarily reflect the conduct of the trial. Reviewing research protocols and contacting trialists for more information may improve quality assessment.

Footnotes

  • Contributors HPS and BD conceptualised the study, were involved in all aspects of the study, and wrote the first draft of the paper. SD and AK contributed to the study design, collection of data, analysis and interpretation of the data, and writing the report. MC contributed to the study design, interpretation of the data, and writing the report. CS and SS contributed to the collection of data and writing the report. BD will act as guarantor for the paper.

  • Funding This research was supported by the Research Program on Research Integrity, an Office of Research Integrity/National Institute of Health collaboration, grant No 1R01NS/NR44417-01.

  • Competing interests MC is director of the UK Cochrane Centre, which is funded by the NHS research and development programme and part of the international Cochrane Collaboration. The collaboration produces systematic reviews of health care, including randomised trials, but the views expressed here are not necessarily those of the official policy of the Cochrane Collaboration.

  • Ethical approval This study was approved by the University of South Florida Institutional Review Board (No 100449).

  • Accepted 10 October 2003
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