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- Bill-Axelson, Anna, et al.
(författare)
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Experiences of randomization : Interviews with patients and clinicians in the SPCG-IV trial
- 2008
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Ingår i: Scandinavian Journal of Urology and Nephrology. - : Informa UK Limited. - 0036-5599 .- 1651-2065. ; 42:4, s. 358-363
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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- Bill-Axelson, Anna, 1965-
(författare)
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Localized Prostate Cancer : Results From a Randomized Clinical Trial
- 2005
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- 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 futureThe 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.
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- Bill-Axelson, Anna, et al.
(författare)
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No increased prostate cancer incidence after negative transrectal ultrasound guided multiple biopsies in men with increased prostate specific antigen and/or abnormal digital rectal examination.
- 2003
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Ingår i: Journal of Urology. - : Ovid Technologies (Wolters Kluwer Health). - 0022-5347 .- 1527-3792. ; 170:4 Pt 1, s. 1180-3
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Tidskriftsartikel (refereegranskat)abstract
- PURPOSE: We investigated the incidence of prostate cancer after negative transrectal ultrasound (TRUS) guided multiple biopsies. Our secondary aim was to calculate the sensitivity of the extended protocol used.MATERIALS AND METHODS: A cohort of 547 men with elevated prostate specific antigen and/or abnormal digital rectal examination but with results negative for prostate cancer on a mean of 9 TRUS guided biopsies was followed through record linkage to the national cancer Registry. The observed number of prostate cancers was compared with the expected number during the same calendar period in an age matched male population to determine the standardized incidence ratio. The sensitivity of TRUS with multiple biopsies after 5 years of followup was calculated. Relative survival was estimated if there was an excess death rate due to undiagnosed prostate cancer.RESULTS: We found 11 men diagnosed with prostate cancer. The expected number in the age standardized male population was 15, resulting in a standardized incidence ratio of 0.8 (95% CI 0.4 to 1.2). Five-year sensitivity of the extended protocol of TRUS guided biopsies was 95.2% (95% CI 93.5 to 96.4) and relative survival was more than 100%, indicating a selection of men deemed candidates for curative treatment.CONCLUSIONS: Men with clinical suspicion of prostate cancer who are examined by an extended protocol of TRUS guided biopsies negative for cancer do not have an increased incidence of prostate cancer within 6 years compared with an age matched male population. Five-year sensitivity of this protocol was high.
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- Bill-Axelson, Anna, et al.
(författare)
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Radical prostatectomy versus watchful waiting in early prostate cancer
- 2005
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Ingår i: New England Journal of Medicine. - 0028-4793 .- 1533-4406. ; 352:19, s. 1977-1944
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND:In 2002, we reported the initial results of a trial comparing radical prostatectomy with watchful waiting in the management of early prostate cancer. After three more years of follow-up, we report estimated 10-year results.METHODS:From October 1989 through February 1999, 695 men with early prostate cancer (mean age, 64.7 years) were randomly assigned to radical prostatectomy (347 men) or watchful waiting (348 men). The follow-up was complete through 2003, with blinded evaluation of the causes of death. The primary end point was death due to prostate cancer; the secondary end points were death from any cause, metastasis, and local progression.RESULTS:During a median of 8.2 years of follow-up, 83 men in the surgery group and 106 men in the watchful-waiting group died (P=0.04). In 30 of the 347 men assigned to surgery (8.6 percent) and 50 of the 348 men assigned to watchful waiting (14.4 percent), death was due to prostate cancer. The difference in the cumulative incidence of death due to prostate cancer increased from 2.0 percentage points after 5 years to 5.3 percentage points after 10 years, for a relative risk of 0.56 (95 percent confidence interval, 0.36 to 0.88; P=0.01 by Gray's test). For distant metastasis, the corresponding increase was from 1.7 to 10.2 percentage points, for a relative risk in the surgery group of 0.60 (95 percent confidence interval, 0.42 to 0.86; P=0.004 by Gray's test), and for local progression, the increase was from 19.1 to 25.1 percentage points, for a relative risk of 0.33 (95 percent confidence interval, 0.25 to 0.44; P<0.001 by Gray's test).CONCLUSIONS:Radical prostatectomy reduces disease-specific mortality, overall mortality, and the risks of metastasis and local progression. The absolute reduction in the risk of death after 10 years is small, but the reductions in the risks of metastasis and local tumor progression are substantial.
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- Hjertberg, Hans, 1946-
(författare)
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The use of ethanol as a marker to detect and quantify the absorption of irrigation fluid during transurethral resection of the prostate
- 1996
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- During transurethral resection of the prostate (TURP), the irrigation fluid is often absorbed by the circulatory system and/or the region around the prostate occasionally resulting in severe signs and symptoms. Instant detection and quantification of absorption of irrigation fluid have not been possible earlier. A method involving tagging of the irrigation fluid with ethamol for detection and quantification of absorbed irrigation fluid by measurement of ethanol in expired breath (EB) has been developed. The validity of measuring El3 ethanol to detect and quantify absorbed irrigation fluid was studied in 13 patients undergoing TURF. The EB ethanol was compared with three other methods: 1. Isotope tagging of the irrigation fluid and detection of absorbed fluid using a scintillation detector placed over large blood vessels. 2. Measuring changes in serum-sodium every 10 min. 3. Regular interval monitoring (RIM) of the difference between volume used for inigation and volume recovered from patients every 10 min. The method of measming El3 ethanol was found to be highly valid. The possibility of detecting absorption and the incidence of absorption using EB ethanol in the clinical routine was studied in 192 patients undergoing TURP. Half of them absorbed irrigation fluid, 25% absorbed more than 400 ml. The proportion of patients absorbing inigationlhlld was the same for both experienced and inexperienced resectionists. Clinical assessment of absorption of irrigation fluid was perfonned by the resectionists and the supervising nurses in 118 patients undergoing TURP. Prerequisites for massive absorption were found by the resectionist in 8/9 patients. The resectionist falsely indicated absorption in 22 patients. The nurses conectly indicated 3/9 patients and falsely indicated 4 patients. To investigate the method measuring EB ethanol to detect absorption of inigation fluid during general anaesthesia, 20 patients undervent TURP and EB ethanol was compared to the RIM method. There was a good correlation between the methods. Elevated pressure in the bladder-prostatic fossa is a prerequisite for absorption of irrigation fluid. Detection and quantification of absorbed irrigation fluid by EB ethanol was used for eompming 102 patients operated on with and without a pressure warning device alarming at 1.5 kPa in the bladder. Using the device reduced both the volume of absorbed irrigation fluid, and the number of patients absorbing irrigation fluid. Both ethanol per se and haemodilution by absorbed irrigation fluid may have impacts on the coagulation system. To investigate the influence of absorption of ethanol tagged mannitol on bleeding time, measurements were perl'omed before and after TURP in 57 patients. No difference in bleeding time was found among patients who absorbed irrigation fluid as compared to those who did not. In conclusion, measurement of ethanol in EB for detection and qum1tification of absorbed irrigation fluid is a highly valid method when compared to three other methods. Absorption of irrigation fluid was found in 50% of the patients tmdergoing TURP. Clinical assessments of absorption of irrigation fluid are inreliable. EB ethanol can be used in patients dllling general anaesthesia. Using a pressure warning device decreases the volume of absorbed irrigation fluid, a~ well as the number of patients absorbing it. Absorption of etillmol tagged mannitol as irrigation fluid has no influence on bleeding time.
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- Holmberg, Lars, et al.
(författare)
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A randomized trial comparing radical prostatectomy with watchful waiting in early prostate cancer
- 2002
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Ingår i: New England Journal of Medicine. - 0028-4793 .- 1533-4406. ; 347:11, s. 781-789
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Radical prostatectomy is widely used in the treatment of early prostate cancer. The possible survival benefit of this treatment, however, is unclear. We conducted a randomized trial to address this question. METHODS: From October 1989 through February 1999, 695 men with newly diagnosed prostate cancer in International Union against Cancer clinical stage T1b, T1c, or T2 were randomly assigned to watchful waiting or radical prostatectomy. We achieved complete follow-up through the year 2000 with blinded evaluation of causes of death. The primary end point was death due to prostate cancer, and the secondary end points were overall mortality, metastasis-free survival, and local progression. RESULTS: During a median of 6.2 years of follow-up, 62 men in the watchful-waiting group and 53 in the radical-prostatectomy group died (P=0.31). Death due to prostate cancer occurred in 31 of 348 of those assigned to watchful waiting (8.9 percent) and in 16 of 347 of those assigned to radical prostatectomy (4.6 percent) (relative hazard, 0.50; 95 percent confidence interval, 0.27 to 0.91; P=0.02). Death due to other causes occurred in 31 of 348 men in the watchful-waiting group (8.9 percent) and in 37 of 347 men in the radical-prostatectomy group (10.6 percent). The men assigned to surgery had a lower relative risk of distant metastases than the men assigned to watchful waiting (relative hazard, 0.63; 95 percent confidence interval, 0.41 to 0.96). CONCLUSIONS: In this randomized trial, radical prostatectomy significantly reduced disease-specific mortality, but there was no significant difference between surgery and watchful waiting in terms of overall survival.
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- Holmberg, Lars, et al.
(författare)
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Prognostic markers under watchful waiting and radical prostatectomy
- 2006
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Ingår i: Hematology/Oncology Clinics of North America. - : Elsevier. - 0889-8588 .- 1558-1977. ; 20:4, s. 845-855
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Tidskriftsartikel (refereegranskat)abstract
- A suitable setting to analyze factors that determine prognosis or treatment response in prostate cancer is an unbiased comparison of radical prostatectomy and watchful waiting as in the Scandinavian Prostate Cancer Group Trial number 4. In our previous presentation of 10-year results, we studied Gleason score, serum prostate-specific antigen (PSA) at diagnosis, and age at diagnosis as modifiers of the effect of radical prostatectomy on survival. Because overall prognostic information obtained by these parameters or by tumor stage was not provided in our publication, we now present these data in the two study arms separately.
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