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Article of the Month: ProCare Trial

Every Month the Editor-in-Chief selects an Article of the Month from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one.

ProCare Trial: a phase II randomized controlled trial of shared care for follow-up of men with prostate cancer

Jon D. Emery*,,, Michael Jefford§,¶, Madeleine King**,††, Dickon Hayne‡‡,§§, Andrew Martin¶¶, Juanita Doorey, Amelia Hyatt, Emily Habgood*, Tee Lim***Cynthia Hawks‡‡,§§, Marie Pirotta*, Lyndal Trevena††† and Penelope Schoeld§,¶,‡‡‡

 

*Department of General Practice, University of Melbourne, Carlton, Western Health and the Victorian Comprehensive Cancer Centre, Melbourne, Vic., School of Primary Aboriginal and Rural Health Care, University of Western Australia, Crawley, WA, §Sir Peter MacCallum Department of Oncology, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Parkville, Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, East Melbourne, Vic., **Quality of Life Ofce, Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, ††Sydney Medical School, University of Sydney, Sydney, NSW, ‡‡School of Surgery, University of Western Australia, Crawley,WA, §§Department of Urology, Fiona Stanley Hospital, Perth, WA, ¶¶NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, ***Genesis Cancer Care, Department of Radiation Oncology, Fiona Stanley Hospital, Perth, WA, †††Primary Health Care, Sydney School of Public Health, University of Sydney, Sydney, NSW, and ‡‡‡Department of Psychology, Swinburne University of Technology, Melbourne, Vic., Australia

 

Abstract

Objectives

To test the feasibility and efficacy of a multifaceted model of shared care for men after completion of treatment for prostate cancer.

Patients and Methods

Men who had completed treatment for low- to moderate-risk prostate cancer within the previous 8 weeks were eligible. Participants were randomized to usual care or shared care. Shared care entailed substituting two hospital visits with three visits in primary care, a survivorship care plan, recall and reminders, and screening for distress and unmet needs. Outcome measures included psychological distress, prostate cancer-specific quality of life, satisfaction and preferences for care and healthcare resource use.

march-2017-aotm

Results

A total of 88 men were randomized (shared care n = 45; usual care n = 43). There were no clinically important or statistically significant differences between groups with regard to distress, prostate cancer-specific quality of life or satisfaction with care. At the end of the trial, men in the intervention group were significantly more likely to prefer a shared care model to hospital follow-up than those in the control group (intervention 63% vs control 24%; P<0.001). There was high compliance with prostate-specific antigen monitoring in both groups. The shared care model was cheaper than usual care (shared care AUS$1411; usual care AUS$1728; difference AUS$323 [plausible range AUS$91–554]).

Conclusion

Well-structured shared care for men with low- to moderate-risk prostate cancer is feasible and appears to produce clinically similar outcomes to those of standard care, at a lower cost.

Editorial: Rethinking cancer surveillance with shared-care models and survivorship plans: the time is now!

Urologists are increasingly facing significant practice concerns related to timely access, surgeon availability, clinical throughput and rising cost of care, yet little has changed over the years regarding the routine postoperative surveillance of urological cancers. While urologists have appropriately focused evaluations on oncological outcomes and procedure-specific quality-of-life concerns, the ability to maintain this practice model in the setting of more new patients (and subsequently more cancer survivors) seems unrealistic. In addition, gaps exist with the current model related to timely and effective communication to the local care team and assurances that specialists comprehensively address all concerns raised by patients. Furthermore, the role of the local care team in cancer survivorship remains poorly defined. Recognising these and other unmet needs in cancer care survivorship, the American Cancer Society (ACS) and the American Society of Clinical Oncology (ASCO) recently published guidelines on cancer survivorship [1-3]. The guidelines recommend a standardised approach to follow-up with emphasis on quality, comprehensive patient assessments, value, and shared use of a multidisciplinary team. With prostate cancer survivorship, for instance, ASCO recommends PSA checks every 6–12 months for the first 5 years and then annually (higher-risk patients can have more frequent checks), adherence to ACS guidelines for early detection of prostate cancer, assessment of physical and psychological effects of prostate cancer and it’s treatments, and annual assessments for long-term or late side-effects [3]. To help with the coordination of care between the patient, the oncological specialist, and the local primary care provider, survivorship care plans have been developed. [4]. While use of survivorship care plans has been sparse in urology to date, new mandates will spur their use in the coming years and development will likely involve innovative healthcare delivery solutions.

Leading the way in this nascent field, Emery et al. [4] report, in this issue of BJUI, an innovative phase II prospective randomised study on the feasibility of a novel shared-care model for follow-up of patients with prostate cancer. Men who had completed treatment for low- and moderate-risk prostate cancer were randomised to undergo usual care or shared care with the assistance of the patient’s primary care team. The novel shared-care model substituted two postoperative urology visits with three postoperative visits in primary care, provided patients and primary care providers a survivorship care plan, included appointment reminders, and provided a novel mechanism to screen for distress and other unmet needs. Among the 88 men randomised in the prospective study, no significant differences were noted between delivery models for satisfaction of care, overall quality of life, incidence of distress, or compliance with serum PSA testing. Patients in the shared-care model were significantly more likely to prefer the new model compared to normal care (cases, 63% vs controls, 24%, P < 0.001). Importantly, the shared-care model was also more economical, saving 323 Australian dollars compared to usual care [4].

The authors should be congratulated for their well-designed study and early contribution to the field. Rethinking all aspects of care delivery will become increasingly important as the practice of urology responds to access limitations, the shortage of urologists, and financial pressures of value-based reimbursement. The report also engenders many questions about the ideal care model of the future, composition of the collaborative care team, and the importance of making evidence-based clinical recommendations. For instance, are already overburdened primary care providers ideal or realistic in shared-care models? Should care remain primarily under the control of urologist with assistance provided by other current (e.g. advance practice providers, urology nurses) or future team member roles (e.g. survivorship care coordinators)? What role can the patient alone play in a self-guided survivorship care plan under the watchful eye of the collaborative care team acting asynchronously? How can enabling technologies such as smartphones, mobile applications, wearables, and video-conferencing contribute to high-value cancer surveillance building upon the principles highlighted in the current article and further engaging patients in their cancer survivorship care? [5]. Lastly, what actually are the evidence-based imperatives of survivorship care (what risk groups, what testing intervals and duration of testing) that provide measurable value to the patient experience? In the current study [4], for instance, high risk patients were excluded but ultimately these patients may be best suited for comprehensive survivorship care. Future work on survivorship and care models will hopefully continue to advance ‘win-win’ situations where patients and providers alike experience increasingly high-value systems of healthcare delivery.

Matthew T. Gettman

 

Mayo Clinic Department of Urology, 200 First Street, SW, Rochester, MN 55905, USA

 

References

 

1 Mayer DK, Nekhlyudov L, Snyder CF, Merrill JK , Wollins DS, Shulman LN. American Society of Clinical Oncology clinical expert statement on cancer survivorship care planning. J Oncol Pract 2014; 10: 34551

 

2 Skolarus TA, Wolf AM, Erb NL et al. American Cancer Society prostate cancer survivorship care guidelines. CA Cancer J Clin 2014; 64: 22549

 

 

 

 

Article of the week: Dutch GPs influenced by ERSPC PSA study

Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video of Miss van der Meer and Dr Blanker discussing their article.

If you only have time to read one article this week, it should be this one.

Impact of the European Randomized Study of Screening for Prostate Cancer (ERSPC) on prostate-specific antigen (PSA) testing by Dutch general practitioners

Saskia Van der Meer, Boudewijn J. Kollen*, Willem H. Hirdes, Martijn G. Steffens, Josette E.H.M. Hoekstra-Weebers, Rien M. Nijman and Marco H. Blanker*

Department of Urology, Isala Clinics, Zwolle, and Departments of *General Practice, Psychosocial services and Urology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands

OBJECTIVE

• To determine the impact of the European Randomized Study of Screening for Prostate Cancer (ERSPC) publication in 2009 on prostate-specific antigen (PSA) level testing by Dutch general practitioners (GPs) in men aged ≥40 years.

MATERIALS AND METHODS

• Retrospective study with a Dutch insurance company database (containing PSA test claims) and a large district hospital-laboratory database (containing PSA-test results).

• The difference in primary PSA-testing rate as well as follow-up testing before and after the ERSPC was tested using the chi-square test with statistical significance at P < 0.05.

RESULTS

• Decline in PSA tests 4 months after ERSPC publication, especially for men aged ≥60 years.

• Primary testing as well as follow-up testing decreased, both for PSA levels of <4 ng/mL as well as for PSA levels of 4–10 ng/mL.

• Follow-up testing after a PSA level result of >10 ng/mL moderately increased (P = 0.171).

• Referral to a urologist after a PSA level result of >4 ng/mL decreased slightly after the ERSPC publication (P = 0.044).

CONCLUSIONS

• After the ERSPC publication primary PSA testing as well as follow-up testing decreased.

• Follow-up testing seemed not to be adequate after an abnormal PSA result. The reasons for this remain unclear.

 

Read Previous Articles of the Week

 

Editorial: Impact of ERSPC study on PSA testing in the Netherlands

General practitioner (GP)’s view on screening for prostate cancer in the Netherlands: the impact of a randomized trial

I am grateful to be given the opportunity to provide an editorial comment on a so-far unique publication investigating the impact of results of the European Randomized study of Screening for Prostate Cancer (ERSPC) on the attitude of Dutch GPs in requesting a serum determination of PSA in men aged >40 years. Access to data from one of the major health insurance companies and the structure and data acquisition of regional laboratories in the Netherlands provided an opportunity to carry out the project. This included the differentiation of age groups, of primary as opposed to repeat PSA testing and, in the case of the hospital database, of repeat PSA testing within 1 year, which provided the opportunity to address the primary goal of the study: the evaluation of the difference in primary PSA testing rates as well as follow-up testing before and after the 2009 publication of interim data from the ERSPC study. The fact that a Dutch translation of this publication and a recommendation by the Dutch Association of General Practitioners (Nederlands Huisartsen Genootschap, NHG) were mailed at the same time and the fact that GP guidelines had not been changed since 2005 in the Netherlands provided an important basis for the reported study.

Two different databases were used and PSA testing was evaluated 1 year before and 1 year after March 2009 (excluding the month March 2009). An overview of the data acquisition and results is given in Table 1. In brief, the data based on insurance claims show a significant decrease in PSA use before and after the 2009 publication. This decrease was less pronounced or not seen at all in men aged 70–80 or >80 years. The study selectively identified men in the ERSPC region of Rotterdam after exclusion of those assigned for re-testing in the screening arm. In line with earlier investigations, the PSA testing rate in the Rotterdam region was considerably higher then in the rest of the Netherlands. This effect was blamed on increased awareness and possibly on the motivation of men randomized into the control group of the study. The so-called ‘hospital database’ refers to a regional GP laboratory. It remains unexplained why only 2098 men of the total of 9766 men who were identified as having undergone primary PSA testing (Tables 1 and 2 in the study) were included in the analysis. These data show that there was no overall difference in testing before and after the ERSPC publication, but the proportion of re-testing decreased significantly between the two periods.

Table 1: Data acquisition and results.

Several comments can be made on this study. First, information provided on the insurance claims database allows an estimate of the proportion of men in whom PSA is evaluated (123 996/715 000 = 17.3%) and of those who undergo primary PSA testing for early diagnostic purposes (66 848/715 000 = 9.4%). The overall figure contrasts sharply with the results of a study by the Central Bureau of Statistics in the Netherlands, published in 2006. The study shows PSA use of 30–40% for the age groups 60–70 years or older.

Second, as the authors acknowledge, the differentiation between primary PSA tests for the purpose of early diagnosis and for other purposes may not be entirely reliable; however, the bias resulting from possibly incorrect assumptions is likely to be small.

Third, the sub-analysis of data coming from the Rotterdam region is likely to show the impact of greater awareness resulting from written informed consent before randomization and the effect of randomization into a control group. The data confirm an earlier evaluation of this subject (reference 7 in Van der Meer et al.) and at the same time provide a rough estimate of the level of contamination which may take place in the ERSPC study, Rotterdam region.

Fourth, it is interesting to see how age and previous PSA values influence the request for repeat PSA studies. It is counterintuitive (Table 3 in Van der Meer et al.) that even in the critical PSA range 4–10 ng/mL a significant decrease of PSA use within 1 year was seen. The multivariate analysis shows that study period before and after 2009, PSA categories and age groups are all significantly related to the decrease of PSA re-testing within 1 year.

Finally, as one of the initiators of the ERSPC study, I should like to refer to two important follow-up publications (Schröder et al.Heijnsdijk et al.) that point to the over-diagnosis and over-treatment of prostate cancer as the main reasons why the almost 30% reduction in prostate cancer mortality in screened men cannot (yet) be used for establishing population-based screening. For these reasons, the authors fully agree with the viewpoint of the Dutch GP Association and the recommendation against routine use of PSA-driven screening for prostate cancer; however, as pointed out in the last sentences of their paper instruments are now available to decrease over-diagnosis and the rate of unnecessary biopsies. In addition to that, it should be realized that men who are well informed and wish to be tested for prostate cancer cannot be refused PSA testing. To assist this process, the International Society of Urology (SIU) and the international movement ‘Movember’ have recently made available on their websites a validated decision aid for men who wish to be tested, their GPs and their treating urologists.

Fritz H. Schröder
Erasmus Medical Center, Rotterdam, The Netherlands.

Video: PSA testing decreased in the Netherlands after ERSPC study

Impact of the European Randomized Study of Screening for Prostate Cancer (ERSPC) on prostate-specific antigen (PSA) testing by Dutch general practitioners

Saskia Van der Meer, Boudewijn J. Kollen*, Willem H. Hirdes, Martijn G. Steffens, Josette E.H.M. Hoekstra-Weebers, Rien M. Nijman and Marco H. Blanker*

Department of Urology, Isala Clinics, Zwolle, and Departments of *General Practice, Psychosocial services and Urology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands

OBJECTIVE

• To determine the impact of the European Randomized Study of Screening for Prostate Cancer (ERSPC) publication in 2009 on prostate-specific antigen (PSA) level testing by Dutch general practitioners (GPs) in men aged ≥40 years.

MATERIALS AND METHODS

• Retrospective study with a Dutch insurance company database (containing PSA test claims) and a large district hospital-laboratory database (containing PSA-test results).

• The difference in primary PSA-testing rate as well as follow-up testing before and after the ERSPC was tested using the chi-square test with statistical significance at P < 0.05.

RESULTS

• Decline in PSA tests 4 months after ERSPC publication, especially for men aged ≥60 years.

• Primary testing as well as follow-up testing decreased, both for PSA levels of <4 ng/mL as well as for PSA levels of 4–10 ng/mL.

• Follow-up testing after a PSA level result of >10 ng/mL moderately increased (P = 0.171).

• Referral to a urologist after a PSA level result of >4 ng/mL decreased slightly after the ERSPC publication (P = 0.044).

CONCLUSIONS

• After the ERSPC publication primary PSA testing as well as follow-up testing decreased.

• Follow-up testing seemed not to be adequate after an abnormal PSA result. The reasons for this remain unclear.

 

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