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Experiences of randomization: Interviews with patients and clinicians in the SPCG-IV trial
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Urology.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Caring Sciences.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Urology.
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2008 (English)In: Scandinavian Journal of Urology and Nephrology, ISSN 0036-5599, E-ISSN 1651-2065, Vol. 42, no 4, 358-363 p.Article in journal (Refereed) Published
Abstract [en]

Objective. Recruitment of both patients and clinicians to randomized trials is difficult. Low participation carries the risk of terminating studies early and making them invalid owing to insufficient statistical power. This study investigated patients' and clinicians' experiences of randomization with the aim of facilitating trial participation in the future. Material and methods. This was a qualitative study using content analysis. Patients offered to participate in a randomized trial and randomizing clinicians were interviewed. Five participants, four non-participants and five randomizing clinicians were interviewed, 2-8 years from randomization. Results. Clinicians used strategies in interaction with the patients to facilitate decision making. Patients' attitudes differed and experiences of relatives or friends were often stated as reasons for treatment preferences. Patients described that letting chance decide treatment was a difficult barrier to overcome for randomization. The clinicians used a number of different strategies perceived to make randomization more acceptable to their patients. The clinicians' own motivation for randomizing patients for trials depended on the medical relevance of the study question and the clinicians' major obstacle was to maintain equipoise over time. Regular meetings with the study group helped to maintain equipoise and motivation. Conclusions. To establish a good platform for randomization the clinician needs to know about the patient's treatment preferences and the patient's attitude concerning the role of the clinician to facilitate decision making. The strategies used by the clinicians were perceived as helpful and could be tested in an intervention study.

Place, publisher, year, edition, pages
2008. Vol. 42, no 4, 358-363 p.
Keyword [en]
prostate cancer, interview, randomized, content analyzis
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-92867DOI: 10.1080/00365590801950253ISI: 000259092300008PubMedID: 18609272OAI: oai:DiVA.org:uu-92867DiVA: diva2:166174
Available from: 2005-05-12 Created: 2005-05-12 Last updated: 2015-02-20Bibliographically approved
In thesis
1. Localized Prostate Cancer: Results From a Randomized Clinical Trial
Open this publication in new window or tab >>Localized Prostate Cancer: Results From a Randomized Clinical Trial
2005 (English)Doctoral thesis, comprehensive summary (Other academic)
Alternative title[sv]
Lokaliserad prostatacancer : Resultat från en randomiserad klinisk studie
Abstract [en]

The aims of the thesis were to

• explore whether radical prostatectomy is beneficial compared with watchful waiting in survival and disease progression

• find possible effect modifiers

• evaluate a protocol of multiple biopsies and investigate if men with previous benign prostate biopsies are a group at risk for later prostate cancer

• inquire into patients’ and clinicians’ experiences of randomization in order to find out what made this study possible to conduct, and thereby contribute to improve randomization in the future

The background material was a large randomized clinical trial, the Scandinavian Prostatic Cancer Group Study Number 4, or SPCG-4, which was open for inclusion from February 1989 through December 1999. It comprised 695 men in Sweden, Finland and Iceland who had localized prostate cancer and were randomized to either radical prostatectomy or watchful waiting.

After a mean follow-up time of 6.2 years the first analyses, according to intention-to-treat, showed that radical prostatectomy reduced disease specific mortality, risk of metastases and risk of local progression but did not statistically significantly reduce overall mortality.

The second analyses confirmed our earlier findings and furthermore, at ten years, radical prostatectomy also statistically significantly reduced overall mortality. Age appeared as an independent effect modifier that will be further investigated.

A total of 547 men, with a suspicion of prostate cancer that had undergone multiple biopsies, and whose biopsies had benign histology were later compared with the background population to evaluate whether they were a group at risk of developing prostate cancer. Within six years of follow-up, there was no increased risk of prostate cancer.

Patients as well as clinicians used individual strategies to cope with the situation. The randomizing clinician has to understand the patient’s strategy and his expectations in order to individualize the information accordingly.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2005. 45 p.
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 25
Surgery, prostate cancer, localized, randomized, biopsies, interviews, Kirurgi
National Category
urn:nbn:se:uu:diva-5737 (URN)91-554-6206-5 (ISBN)
Public defence
2005-05-13, Rudbecksalen, Rudbecklaboratoriet, Dag Hammarsköldsväg 20, Uppsala, 09:15
Available from: 2005-05-12 Created: 2005-05-12Bibliographically approved

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