The quality of reporting of randomized controlled trials in solid organ transplantation

Authors

  • Liset H. M. Pengel,

    1. Clinical Effectiveness Unit, Centre for Evidence in Transplantation, Royal College of Surgeons of England and the London School of Hygiene and Tropical Medicine, University of London, London, UK
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  • Leticia Barcena,

    1. Clinical Effectiveness Unit, Centre for Evidence in Transplantation, Royal College of Surgeons of England and the London School of Hygiene and Tropical Medicine, University of London, London, UK
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  • Peter J. Morris

    1. Clinical Effectiveness Unit, Centre for Evidence in Transplantation, Royal College of Surgeons of England and the London School of Hygiene and Tropical Medicine, University of London, London, UK
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Peter J. Morris, AC, FRS, FRCS, Centre for Evidence in Transplantation, Royal College of Surgeons of England, 35-43 Lincoln’s Inn Fields, London WC2A 3PE, UK. Tel.: +44 20 7869 6627; fax: +44 20 7869 6644;
e-mail: pmorris@rcseng.ac.uk

Summary

Randomized controlled trials (RCTs) of interventions provide the highest level of evidence about efficacy but their value either alone or within a meta-analysis is dependent on its methodological quality. For this reason recent RCTs in organ transplantation were assessed for quality. RCTs published between 2004 and 2006 (= 332) were assessed, after excluding duplicate and nonEnglish reports. Quality was evaluated using the Jadad score plus allocation concealment and intention to treat analysis. We noted journal type, journal author instructions, funding source, sample size and number and location of study centres. Around one-third of RCTs had a Jadad score of 3 or greater (indication of a methodologically good quality trial) and the other two parameters were satisfied in just over one third. Although the majority of trials were published in speciality journals the quality of those published in general journals was superior. Commercially sponsored trials were of better quality as were multicentre trials in contrast to single centre trials. Overall quality of reporting of RCTs in organ transplantation is poor and as RCTs provide the highest level of evidence in evaluations of interventions there needs to be a concerted effort within the transplant community to improve the standards of RCTs.

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