BMJ  2004;328:286 (31 January), doi:10.1136/bmj.328.7434.286-a

Letter

Quality of randomised controlled trials

Quality of trial methods is not good in all disciplines

EDITOR—The paper by Soares et al is a useful reminder of the important distinction between quality of trial reporting and quality of trial methods.¹

An established, motivated, and informed group such as the Radiation Therapy Oncology Group is likely not only to have well designed trials but to conduct them according to the protocol. Soares et al show that omission of important information in the trial reports of such a group can now be looked at more benevolently.

It is too large a leap of faith to extend this to other areas—for example, to small, often dated, suboptimal, underfunded trials. My experience in chasing up further information for trials in orthopaedics has yielded mixed and often disappointing results. Tracking down the trial investigator(s) has been difficult. Of those who could be found and replied, few were able to give completely satisfactory replies, sometimes because they no longer had access to documentation, even for comparatively recent trials.

Allocation concealment is a prime measure of trial quality and often used to select studies for systematic reviews. Allocation concealment was achieved in all trials conducted by the Radiation Therapy Oncology Group, despite being reported in only 42% of its papers.¹ However, in our Cochrane review of eight trials of preoperative traction for hip fracture, further information on the method of randomisation was received for four of the six trials whose reports had not adequately described the method of randomisation.² Allocation was concealed in one trial but another was quasi-randomised; information on the other two trials remained insufficient to make a judgment.

School of Health and Social Care, University of Teesside, Middlesbrough TS1 3BA h.handoll{at}ed.ac.uk

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Competing interests: None declared.

References

1. 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: 22-4. (3 January.)[Abstract/Free Full Text]
2. Parker MJ, Handoll HHG. Pre-operative traction for fractures of the proximal femur. Cochrane Database Syst Rev 2003;(3): CD000168 [GenBank] .

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Relevant Article

Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group

Heloisa P Soares, Stephanie Daniels, Ambuj Kumar, Mike Clarke, Charles Scott, Suzanne Swann, and Benjamin Djulbegovic
BMJ 2004 328: 22-24. [Abstract] [Full Text] [PDF]