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Failure to address potential bias in nonrandomised controlled clinical trials may cause lack of evidence on patientreported outcomes: a method study

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Title: Failure to address potential bias in nonrandomised controlled clinical trials may cause lack of evidence on patientreported outcomes: a method study
Author(s): Peinemann, Frank; Labeit, Alexander M.; Thielscher, Christian; Pinkawa, Michael
Abstract: Objectives: We conducted a workup of a previously published systematic review and aimed to analyse why most of the identified non-randomised controlled clinical trials with patient-reported outcomes did not match a set of basic quality criteria. Setting: There were no limits on the level of care and the geographical location. Participants: The review evaluated permanent interstitial low-dose rate brachytherapy in patients with localised prostate cancer and compared that intervention with alternative procedures such as external beam radiotherapy, radical prostatectomy and no primary therapy. Primary outcome measure: Fulfilment of basic inclusion criteria according to a Participants, Interventions, Comparisons, Outcomes (PICO) framework and accomplishment of requirements to contain superimposed risk of bias. Results: We found that 21 of 50 excluded non-randomised controlled trials did not meet the PICO inclusion criteria. The remaining 29 studies showed a lack in the quality of reporting. The resulting flaws included attrition bias due to loss of follow-up, lack of reporting baseline data, potential confounding due to unadjusted data and lack of statistical comparison between groups. Conclusions: With respect to the reporting of patient-reported outcomes, active efforts are required to improve the quality of reporting in non-randomised controlled trials concerning permanent interstitial low-dose rate brachytherapy in patients with localised prostate cancer.
Issue Date: 2014-06-04
Publisher: BMJ Publishing Group
Citation Info: Peinemann, Frank, Alexander Michael Labeit, Christian Thielscher, and Michael Pinkawa. "Failure to address potential bias in non-randomised controlled clinical trials may cause lack of evidence on patient-reported outcomes: a method study." BMJ open 4, no. 6 (2014): e004720. DOI: 10.1136/bmjopen-2013-004720
Type: Article
Description: This is a copy of an article published in the BMJ Open. © Peinemann F, Labeit AM, Thielscher C, et al. http://bmjopen.bmj.com/
URI: http://hdl.handle.net/10027/21160
ISSN: 2044-6055
Date Available in INDIGO: 2016-09-14
 

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