Universität zu Köln

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

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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:	Creators Email ORCID ORCID Put Code Peinemann, Frank UNSPECIFIED orcid.org/0000-0002-4727-1313 UNSPECIFIED Labeit, Alexander Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Thielscher, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Pinkawa, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED
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
Uncontrolled Keywords:	Keywords Language QUALITY-OF-LIFE; LOCALIZED PROSTATE-CANCER; DOSE-RATE BRACHYTHERAPY; EXTERNAL-BEAM RADIOTHERAPY; RADICAL RETROPUBIC PROSTATECTOMY; PERMANENT I-125 BRACHYTHERAPY; NEOADJUVANT HORMONAL-THERAPY; SEXUAL FUNCTION; RADIATION-THERAPY; ERECTILE DYSFUNCTION Multiple languages Medicine, General & Internal Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/44989