Suggested guidelines for reporting clinical results in transplantation trials |
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Authors: | Sebastian Martini Petra Glander Lutz Fritsche Franca Fleiner Klemens Budde |
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Affiliation: | aDepartment of Nephrology, Charité Hospital, Humboldt University Berlin, 10117 Berlin, Germany |
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Abstract: | Randomized controlled trials are essential for decision making and improving patient care. Although the number of published clinical trials in the field of transplantation is constantly rising, recent publications addressed problems of proper reporting of study results. Far too often, not even the key data (patient and graft survival, rejection rates, transplant relevant characteristics of the population, and details on the immunosuppressive therapy) were given. Good reporting should include primary and secondary outcomes, graft and patient survival, acute rejection rates (biopsy proven acute rejections and all treated), and clear accounting of the participant number throughout the different stages of a study. Several recent attempts (Consolidated Standards of Reporting Trials guidelines, submission of the study protocol, registry database) failed to improve or improved only partly the reporting quality. To improve reporting quality of randomized controlled trials in the future, we propose to use a comprehensive checklist with modified criteria of the Consolidated Standards of Reporting Trials guidelines to better reflect the special needs in the field of transplantation. |
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