Peinemann, Frank ORCID: 0000-0002-4727-1313, Labeit, Alexander Michael, Thielscher, Christian and Pinkawa, Michael
(2014).
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 (6).
LONDON:
BMJ PUBLISHING GROUP.
ISSN 2044-6055
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.
Item Type: | Journal Article | ||||||||||||||||||||
Creators: |
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URN: | urn:nbn:de:hbz:38-449892 | ||||||||||||||||||||
DOI: | 10.1136/bmjopen-2013-004720 | ||||||||||||||||||||
Journal or Publication Title: | BMJ Open | ||||||||||||||||||||
Volume: | 4 | ||||||||||||||||||||
Number: | 6 | ||||||||||||||||||||
Date: | 2014 | ||||||||||||||||||||
Publisher: | BMJ PUBLISHING GROUP | ||||||||||||||||||||
Place of Publication: | LONDON | ||||||||||||||||||||
ISSN: | 2044-6055 | ||||||||||||||||||||
Language: | English | ||||||||||||||||||||
Faculty: | Unspecified | ||||||||||||||||||||
Divisions: | Unspecified | ||||||||||||||||||||
Subjects: | no entry | ||||||||||||||||||||
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URI: | http://kups.ub.uni-koeln.de/id/eprint/44989 |
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