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dc.contributor.authorPeinemann, Frank
dc.contributor.authorLabeit, Alexander M.
dc.contributor.authorThielscher, Christian
dc.contributor.authorPinkawa, Michael
dc.date.accessioned2016-09-14T19:56:52Z
dc.date.available2016-09-14T19:56:52Z
dc.date.issued2014-06-04
dc.identifier.bibliographicCitationPeinemann, 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-2013-004720en_US
dc.identifier.issn2044-6055
dc.identifier.urihttp://hdl.handle.net/10027/21160
dc.descriptionThis is a copy of an article published in the BMJ Open. © Peinemann F, Labeit AM, Thielscher C, et al. http://bmjopen.bmj.com/en_US
dc.description.abstractObjectives: 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.en_US
dc.language.isoen_USen_US
dc.publisherBMJ Publishing Groupen_US
dc.titleFailure to address potential bias in nonrandomised controlled clinical trials may cause lack of evidence on patientreported outcomes: a method studyen_US
dc.typeArticleen_US


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