PEER REVIEW HISTORY ARTICLE DETAILS

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1 PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form ( and are provided with free text boxes to elaborate on their assessment. These free text comments are reproduced below. ARTICLE DETAILS TITLE (PROVISIONAL) Effect of more intense investigation and treatment of prostate cancer on survivor s physical symptoms, psychological wellbeing and health related quality of life: a two country observational study AUTHORS Gavin, Anna; Donnelly, David; Donnelly, Conan; Drummond, F; Morgan, Eileen; Gormley, Gerard; Sharp, Linda VERSION 1 - REVIEW L. Venderbos Erasmus MC, department of Urology, Rotterdam, the Netherlands 12-Jul-2016 Dear authors, thank you for this nice manuscript on the effect of more intense investigation and treatment of PCa on health utility and HRQoL of survivors. Overall, I think the manuscript is interesting, but I have some comments that I would like to see addressed: - Abstract, subjects: can you add in this section that the higher levels of PSA testing and therewith PCa in the ROI are due to the differences in healthcare system as you describe later on in the introduction? Just very briefly. - Abstract, method: please add that it concerns a cross-sectional study. - Page 6, Limitations: missing of a baseline measurement is not indicated as a limitation, while it actually is. Although the study was set-up as a cross-sectional study, I think it should be mentioned. By asking men on their health at diagnosis in the questionnaire it has been tried to overcome this and create a baseline measurement. This, however, holds the problem of recall bias. - Introduction, reference 4: is this the correct reference for the statement that Only one large long-term randomized controlled trial has identified a significant reduction in deaths associated with PSA screening, but this was accompanied with a high level of overdiagnosis and associated treatment. - Introduction: both healthcare systems seem reluctant towards PSA testing; the National Cancer Forum recommending against screening and the healthcare system of NI limiting the use of PSA testing in primary care. Still you see more screening in ROI than in NI. What can explain this? Why isn t the recommendation by the National Cancer Forum not followed? - Methods: please add a in short the PICTure study to provide some information on the methods of the PICTure trial. - Subjects/patients: please indicate why a 5-year cut-off was chosen? - Explanatory variables: the recall bias on health at diagnosis is a

2 serious limitation. Especially when men are asked on their urinary and sexual symptoms. It is mentioned in the limitations section, but it is not stated how the researchers dealt with this. - Results: the response rates for ROI and NI differ quite a lot. Can it be explained why the response rate was so much lower for the NI group? - Results: the distribution of early disease vs late disease shows variation between ROI and NI with the NI showing a larger percentage of late disease. Is this a reflection of the variation in response rate or caused by the difference in healthcare system? - Page 14, results: so it is actually not so bad that more men were diagnosed with early disease in ROI as it did not seem to affect men their health utility and HRQoL? - Page 22, discussion, line 22: the uptake of screening in ROI seems to contradict the statement of the National Cancer Forum recommending against prostate cancer screening. - Discussion: can you discuss a bit more your finding that patient reported outcomes are very similar in ROI and NI despite different levels of PSA testing and diagnosed PCa in the light of the higher percentage of late disease patients? - Discussion: here again, I understand that patients not having sideeffects is better, but the results may advocate that it may actually not be so bad that more men were diagnosed with early disease in the ROI as their QoL is similarly good to that of men in NI. How would you interpret this with respect to clinical practice? - What are recommendations for future practice? What to learn from this study and what would you advice the National Cancer Forum for instance regarding prostate cancer screening? - Please take a close look at the manuscript to edit small typo s. Maarten Cuypers Tilburg University, The Netherlands 18-Jul-2016 Authors describe results from a large cross-sectional study performed on a sample of PCa patients in two areas in Ireland. Overall authors findings are interesting, useful and analyses appropriate. The findings could contribute to policy making on PSA screening and therefore potentially useful. However, some weaknesses need improvement before I would recommend publishing: 1. Manuscript title should put more emphasis on the fact that two countries with different policies are compared. Suggestion is now made that it is more about specific clinical routines/techniques. The term 'investigation' is confusing, at least for me as non-english native. 2. Not familiar with specific journal rules, but an article summary next to an abstract seems redundant. 3. Abstract should include some background information and explicit research question (so does the introduction section). 4. Some typos appear throughout the manuscript 5. Methods: although previously published, some info would be nice and refer to the protocol 'for a more detailed description' 6. The first lines of the statistical analyses section (page 9) provide a comprehensive summary of the study goal, should use that description in both abstract and introduction, makes it more clear. 7. Analyses seem appropriate and complete

3 8. In the first section of the discussion a causal relation is proposed between country practice rules and study outcomes. However, the cross-sectional nature of this study doesn't allow to make causal inferences. 9. Overall this paper seems to struggle with population outcomes and a between-country comparison. The goal is defined as a between-country comparison, than this should also be the focus of the discussion section. 10. In line with the last limitation; this study's sample is registrybased, non-diagnosed men are not in the sample. It is likely they are more present in NI, so when comparing health outcomes, a distinction should be made between treatment side-effects and disease symptoms. Differences in treatment-side effects are less likely to occur in a country were less Pca is detected, however an equal amount of men will actually have Pca (diagnosed or not diagnosed) and can be affected by it in terms of health outcomes. VERSION 1 AUTHOR RESPONSE Response to the reviewers We wish to thank the reviewers for their useful comments Abstract, subjects: can you add in this section that the higher levels of PSA testing and therewith PCa in the ROI are due to the differences in healthcare system as you describe later on in the introduction? Just very briefly. Included Abstract, method: please add that it concerns a cross-sectional study. Added Page 6, Limitations: missing of a baseline measurement is not indicated as a limitation, while it actually is. Although the study was set-up as a cross-sectional study, I think it should be mentioned. Added By asking men on their health at diagnosis in the questionnaire it has been tried to overcome this and create a baseline measurement. This, however, holds the problem of recall bias. Mentioned in limitations but also could just be due to random errors in recall. Introduction, reference 4: is this the correct reference for the statement that Only one large long-term randomized controlled trial has identified a significant reduction in deaths associated with PSA screening, but this was accompanied with a high level of over-diagnosis and associated treatment. Well spotted, wrong reference used- changed and apologies Introduction: both healthcare systems seem reluctant towards PSA testing; the National Cancer Forum recommending against screening and the healthcare system of NI limiting the use of PSA testing in primary care. Still you see more screening in ROI than in NI. What can explain this? Why isn t the recommendation by the National Cancer Forum followed? The National Cancer Forum advice was not mandatory and would have had little effect on health care providers as the ROI has a complex mixed public private healthcare system. The advice may however have curbed an even greater use of PSA testing. Also in ROI primary care physicians, (GPs) operate in private practice. Most who attend the GP do as a private patient (i.e. they pay a charge in order to be seen and this is not generally reimbursed by private health insurance, even if they hold

4 Private Health Insurance). Moreover, Rapid Access Clinics were established within the National Cancer Control Programmes to ensure rapid hospital referral for prostate biopsy for men with raised PSA levels. This means that there is little incentive for GPs to persuade men not to undergo PSA testing. In contrast NI has a publicly funded healthcare system similar to the NHS with GPs acting as gatekeepers for secondary care with no payments for GP attendance. Also NI has encouraged the following of the National Screening Committee s advice in 2002 and NICE guidelines (2008) aimed at limiting the use of PSA testing in primary care. We have included a new reference for the 2002 guidelines. Page 22, discussion, line 22: the uptake of screening in ROI seems to contradict the statement of the National Cancer Forum recommending against prostate cancer screening. See comment above Methods: please add a in short the PICTure study to provide some information on the methods of the PICTure trial. Added Subjects/patients: please indicate why a 5-year cut-off was chosen? This was required as there were fewer survivors diagnosed in the earlier years for two reasons, one, the levels of prostate cancer diagnosed were lower and secondly as at least 50% of prostate cancer cases are over 70 when diagnosed mortality would have reduced numbers.- added to paper Explanatory variables: the recall bias on health at diagnosis is a serious limitation. Especially when men are asked on their urinary and sexual symptoms. It is mentioned in the limitations section, but it is not stated how the researchers dealt with this. The study examined current health and therefore the outcomes were not subject to recall bias the only items of historic data collected were regarding symptoms at diagnosis, treatments received and method of detection ( symptomatic or asymptomatic). The data on stage of disease was extracted from the population based registries Results: the response rates for ROI and NI differ quite a lot. Can it be explained why the response rate was so much lower for the NI group? We apologise that this is confusing. The numbers quoted are not response rates but rather the proportions of responders from each country, - 70% of responders were from ROI (n=2567) and 30% (n=781) from NI. This reflects the different population sizes (NI. 1.8 million. ROI 3.5 million) and also the higher numbers of prostate cancer patients in ROI- explanation added to paper Results: the distribution of early disease vs late disease shows variation between ROI and NI with the NI showing a larger percentage of late disease. Is this a reflection of the variation in response rate or caused by the difference in healthcare system? It reflects a difference in prostate cancer detection between the two areas. The ROI with higher PSA testing has detected more early disease than NI, asymptomatically detected NI = 66%, ROI 41%, symptomatic patients NI 32%, ROI 58% as recorded in table 1. Asymptomatic men have earlier disease than those who present asymptomatically. Page 14, results: so it is actually not so bad that more men were diagnosed with early disease in ROI as it did not seem to affect men their health utility and HRQoL? Once stage at presentation is taken into account there were no differences in health outcomes however with early patients reporting on average 16% incontinence and 56% erectile dysfunction, in addition to other side effects. The increased numbers diagnosed in ROI however may mean that a higher proportion of the ROI male population aged >50 are living with side effects of prostate cancer treatment

5 Discussion: can you discuss a bit more your finding that patient reported outcomes are very similar in ROI and NI despite different levels of PSA testing and diagnosed PCa in the light of the higher percentage of late disease patients? Thank you for this comment - Added at end of discussion Discussion: here again, I understand that patients not having side-effects is better, but the results may advocate that it may actually not be so bad that more men were diagnosed with early disease in the ROI as their QoL is similarly good to that of men in NI. How would you interpret this with respect to clinical practice? Based on the evidence of our research, the use of PSA to test higher numbers of asymptomatic men as occurred in ROI has not reduced mortality compared to NI but has left many more men with side effects of treatment. We recommended that men are offered a PSA test only after informed discussion as recommended by current guidelines included in text We feel that it is important to consider the population level impact of strategies (albeit informal) for prostate cancer detection. Therefore, while QoL is same when stratified by early/late, there is (as we note above) a significant burden of side-effects in the population due to large numbers of men diagnosed with early disease, that may otherwise not have been detected or treated. Also these men tend to be younger on average so they have to live with these side-effects for longer. What are recommendations for future practice? What to learn from this study and what would you advice the National Cancer Forum for instance regarding prostate cancer screening? See above Please take a close look at the manuscript to edit small typo s. Thank you, we hope these are all corrected now. Reviewer 2 1. Manuscript title should put more emphasis on the fact that two countries with different policies are compared. Suggestion is now made that it is more about specific clinical routines/techniques. The term 'investigation' is confusing, at least for me as non-english native. Abstract and manuscript changed to reflect these comments 2. Not familiar with specific journal rules, but an article summary next to an abstract seems redundant. According to the author guidelines taken from : An 'Article summary' section consisting of the heading: 'Strengths and limitations of this study', and containing up to five short bullet points, no longer than one sentence each, that relate specifically to the methods of the study reported. They should not include the results of the study and should be placed after the abstract. 3. Abstract should include some background information and explicit research question (so does the introduction section). Added to end of introduction - These unique circumstances allow us to investigate, the effect of more intense investigation and treatment of prostate cancer on men s health and wellbeing. Also reflected in shorter form in the abstract aim. 4. Some typos appear throughout the manuscript Thank you and apologies, changed 5. Methods: although previously published, some info would be nice and refer to the protocol 'for a more detailed description'

6 Thank you, changed 6. The first lines of the statistical analyses section (page 9) provide a comprehensive summary of the study goal, should use that description in both abstract and introduction, makes it more clear. Adapted for abstract 7. Analyses seem appropriate and complete 8. In the first section of the discussion a causal relation is proposed between country practice rules and study outcomes. However, the cross-sectional nature of this study doesn't allow to make causal inferences. Agree- changed as below By examining early and late disease patients separately we are able to compare patient reported outcomes between two similar populations with different levels of investigation and treatment. 9. Overall this paper seems to struggle with population outcomes and a between-country comparison. The goal is defined as a between-country comparison, than this should also be the focus of the discussion section. The between country comparison has allowed us to examine the outcome for the individual men in each country. When broken down by stage we found minimal differences in outcomes. However levels of side effects are not insignificant even in early stage patients. We feel that for any screening it is important to consider both the impact on the individuals of undergoing the test, and the impact a population-level. Thus we think that it would be misleading not to discuss the population-level implications of the results 10. In line with the last limitation; this study's sample is registry-based, non-diagnosed men are not in the sample. It is likely they are more present in NI, so when comparing health outcomes, a distinction should be made between treatment side-effects and disease symptoms. Differences in treatment-side effects are less likely to occur in a country where less PCa is detected, however an equal amount of men will actually have PCa (diagnosed or not diagnosed) and can be affected by it in terms of health outcomes. We agree and a normative study is currently underway. VERSION 2 REVIEW Lionne Venderbos Erasmus University Medical Center, department of Urology, Rotterdam, the Netherlands. 19-Sep-2016 Dear authors, thank you for incorporating my comments thoughtfully. I advice the editor to accept this manuscript for publication in BMJ Open. M. Cuypers Tilburg University, The Netherlands 15-Sep-2016 All previous comments seem to be addressed appropriately. Would recommend accepting in its current form.

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