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. 2014 Jun 4;4(6):e004720.
doi: 10.1136/bmjopen-2013-004720.

Failure to address potential bias in non-randomised controlled clinical trials may cause lack of evidence on patient-reported outcomes: a method study

Frank Peinemann  1 , Alexander Michael Labeit  2 , Christian Thielscher  3 , Michael Pinkawa  4
Affiliations

Failure to address potential bias in non-randomised controlled clinical trials may cause lack of evidence on patient-reported outcomes: a method study

Frank Peinemann et al. BMJ Open. .

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.

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Figures

Figure 1
Figure 1
Study flow. PICO: population, intervention, comparator, outcome; PRO: patient-reported outcomes; RCT: randomised controlled trial.
See this image and copyright information in PMC

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References

    1. Peinemann F, Grouven U, Bartel C, et al. Permanent interstitial low-dose rate brachytherapy for patients with localized prostate cancer—a systematic review of randomized and non-randomized controlled clinical trials. Eur Urol 2011;60:881–93 - PubMed
    1. Patrick D, Guyatt GH, Acquadro C. Chapter 17: Patient-reported outcomes. In: Higgins JPT, Green S, eds. Cochrane handbook for systematic reviews of interventions Version 510 [updated March 2011]. Chichester: The Cochrane Collaboration, 2011. www.cochrane-handbook.org
    1. Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med 2010;7:e1000251. - PMC - PubMed
    1. Calvert M, Blazeby J, Altman DG, et al. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA 2013;309:814–22 - PubMed
    1. von Elm E, Altman DG, Egger M, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med 2007;4:e296. - PMC - PubMed

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