Establishing metastatic prostate cancer quality indicators using a modified Delphi approach.

BACKGROUND: There is variation in the care provided to men with metastatic prostate cancer (mPCa). There has been no previous set of quality indicators (QIs) regarding the management of men with mPCa. The objective of this study is to develop a set of international mPCa-specific QIs, which will enable global benchmarking of quality of care. MATERIALS AND METHODS: Potential QIs were identified through a literature review. Fourteen multidisciplinary mPCa experts (representing medical and radiation oncology, nursing, psychology, palliative care and urology) from eight countries participated in a modified Delphi process, which consisted of two online surveys, one face-to-face meeting and two teleconferences. Panelists were asked to rate each indicator's importance and feasibility on a Likert scale from 1 to 9. Indicators that received median importance and median feasibility scores ≥ 7.5, and a disagreement index <1 for both measures, on the final round of voting were included in the final set. RESULTS: There was consensus on 23 QIs out of total of 662. Four regarding "general management", 12 "therapies", three "complications" and four "patient-reported quality of life". One of the inherent limitations of the Delphi process is that there is a small expert panel involved. CONCLUSION: The quality indicator set defined by our process for management of men with mPCa will enable greater understanding of the standard and variation of care globally and will promote consistency of good practice. Future directions will include retrospective evaluation for compliance with these indicators, as well as prospective monitoring.

Knowledge and insights from a maturing international clinical quality registry.

Since 2017, the TrueNTH Global Registry (TNGR) has aimed to drive improvement in patient outcomes for individuals with localized prostate cancer by collating data from healthcare institutions across 13 countries. As TNGR matures, a systematic evaluation of existing processes and documents is necessary to evaluate whether the registry is operating as intended. The main supporting documents: protocol and data dictionary, were comprehensively reviewed in a series of meetings over a 10-month period by an international working group. In parallel, individual consultations with local institutions regarding a benchmarking quality-of-care report were conducted. Four consensus areas for improvement emerged: updating operational definitions, appraisal of the recruitment process, refinement of data elements, and improvement of data quality and reporting. Recommendations presented were drawn from our collective experience and accumulated knowledge in operating an international registry. These can be readily generalized to other health-related reporting programs beyond clinical registries.

Establishing a global quality of care benchmark report.

BACKGROUND: The Movember funded TrueNTH Global Registry (TNGR) aims to improve care by collecting and analysing a consistent dataset to identify variation in disease management, benchmark care delivery in accordance with best practice guidelines and provide this information to those in a position to enact change. We discuss considerations of designing and implementing a quality of care report for TNGR. METHODS: Eleven working group sessions were held prior to and as reports were being built with representation from clinicians, data managers and investigators contributing to TNGR. The aim of the meetings was to understand current data display approaches, share literature review findings and ideas for innovative approaches. Preferred displays were evaluated with two surveys (survey 1: 5 clinicians and 5 non-clinicians, 83% response rate; survey 2: 17 clinicians and 18 non-clinicians, 93% response rate). RESULTS: Consensus on dashboard design and three data-display preferences were achieved. The dashboard comprised two performance summary charts; one summarising site's relative quality indicator (QI) performance and another to summarise data quality. Binary outcome QIs were presented as funnel plots. Patient-reported outcome measures of function score and the extent to which men were bothered by their symptoms were presented in bubble plots. Time series graphs were seen as providing important information to supplement funnel and bubble plots. R Markdown was selected as the software program principally because of its excellent analytic and graph display capacity, open source licensing model and the large global community sharing program code enhancements. CONCLUSIONS: International collaboration in creating and maintaining clinical quality registries has allowed benchmarking of process and outcome measures on a large scale. A registry report system was developed with stakeholder engagement to produce dynamic reports that provide user-specific feedback to 132 participating sites across 13 countries.

Forecasting annual incidence and mortality rate for prostate cancer in Australia until 2022 using autoregressive integrated moving average (ARIMA) models.

OBJECTIVES: Prostate cancer is the second most common cause of cancer-related death in males after lung cancer, imposing a significant burden on the healthcare system in Australia. We propose the use of autoregressive integrated moving average (ARIMA) models in conjunction with population forecasts to provide for robust annual projections of prostate cancer. DESIGN: Data on the incidence and mortality from prostate cancer was obtained from the Australian Institute of Health and Welfare. We formulated several ARIMA models with different autocorrelation terms and chose one which provided for an accurate fit of the data based on the mean absolute percentage error (MAPE). We also assessed the model for external validity. A similar process was used to model age-standardised incidence and mortality rate for prostate cancer in Australia during the same time period. RESULTS: The annual number of prostate cancer cases diagnosed in Australia increased from 3606 in 1982 to 20 065 in 2012. There were two peaks observed around 1994 and 2009. Among the various models evaluated, we found that the model with an autoregressive term of 1 (coefficient=0.45, p=0.028) as well as differencing the series provided the best fit, with a MAPE of 5.2%. External validation showed a good MAPE of 5.8% as well. We project prostate cancer incident cases in 2022 to rise to 25 283 cases (95% CI: 23 233 to 27 333). CONCLUSION: Our study has accurately characterised the trend of prostate cancer incidence and mortality in Australia, and this information will prove useful for resource planning and manpower allocation.

Development of Technologic Solutions to Address Complex Local Requirements of an International Prostate Cancer Clinical Quality Registry.

PURPOSE: To detail the process for importing a defined data set into a centralized global registry via a secure file transfer platform and to understand the barriers to the establishment of a centralized global registry. RESULTS: A bespoke solution was developed to allow transmission of data from international local data centers to a centralized repository. Data elements included in the import template were drawn from existing International Consortium for Health Outcome Measurement variables and refined to ensure accurate benchmarking as well as feasibility in data completeness. The data set was organized in accordance with the prostate cancer care trajectory. Key considerations in developing the data transfer platform included import file format, process of input validation, and technical provisions. Given the diversity in the legislation and ethical requirements with respect to consent, data handling, and cross-border data transfer across geographic locations, we encouraged each local data center to consult with its legal advisors and research ethics committee early on in the process. DISCUSSION: A global collaboration, although highly valuable, posed many challenges because of inconsistent methods of data collection. User acceptance of a system is paramount to the success of establishing a metaregistry. Local information technology support and regular regression testing ensures quality and maintenance of the database. CONCLUSION: We developed a Web-based system to facilitate the collection and secure storage of common data, which is scalable and secure. It is anticipated that through systematic recording of data, global standards of clinical practice and outcomes of care will see vast improvements.

A randomised controlled trial comparing completeness of responses of three methods of collecting patient-reported outcome measures in men diagnosed with prostate cancer.

PURPOSE: The purpose of the study was to compare completeness, timeliness and cost of patient-reported outcome measures (PROMs) collection using telephone, email and post in men with prostate cancer. METHODS: A parallel, three-arm randomised controlled equivalence trial. 1168 patients were randomised to telephone (n = 295), postal (n = 388) and email (n = 385) arms. Participants were asked to provide self-reported responses for 26 items of Expanded Prostate Cancer Index Composite. Cost and resource data were collected from a provider perspective. RESULTS: Equivalence tests showed no difference in completeness in the three arms within a 10% equivalence margin. Men diagnosed in public hospitals were less likely to complete the survey compared to those in private hospitals, OR = 0.19 (95% CI 0.04-0.89) (p = 0.035). The email survey required significantly less time to complete than telephone and postal methods [median time of 2 min (IQR 1,8) vs. 7 min (IQR 6,9) vs. 10 min (IQR 9,12), respectively (p < 0.001)]. The incremental cost effectiveness ratio for email compared to telephone was AUD$1.90, cost-effective if users valued an additional 1% improvement in survey completion greater than AUD$1.90. CONCLUSION: Email method took less time and cost and should be used as the primary PROMs collection, with telephone if men without email or do not respond to email.

Interpolation to define clinical tumor stage in prostate cancer using clinical description of digital rectal examination.

AIM: This study aims to assess characteristics of patients with prostate cancer for whom clinical T stage category (cT) was not documented in the medical record and assess whether specialists had concordant conclusions regarding cT based on digital rectal examination (DRE) notes. METHODS: Data from the Prostate Cancer Outcome Registry - Victoria (PCOR-Vic) were interrogated. Four specialists independently assigned cT to DRE notes. Words, or part thereof, associated with agreement between clinicians were identified. RESULTS: Of the 10 587 men, cT was documented in 8758 (82.7%) cases. Multivariate analysis indicated that poor cT documentation was associated with older patient age (odds ratio [OR] 0.80, 95% confidence interval [CI] 0.66-0.99 if 75.1-85 years; OR 0.50, 95%CI 0.36-0.72 if >85 years); diagnosis via transperineal compared to transrectal ultrasound-guided biopsy (TRUS) (OR 0.68, 95%CI 0.51-0.91); diagnosed in a private hospital (OR 0.85, 95%CI 0.75-0.96); and a diagnostic Gleason score of >8 compared to ≤6 (OR 0.59, 95%CI = 0.48-0.73). cT was more likely documented in men diagnosed via transurethral resection of prostate (OR 2.06, 95%CI 1.64-2.58) compared to TRUS and/or if receiving treatment in a radiotherapy center (OR 3.44, 95%CI 2.80-4.23 for external beam radiotherapy; OR 3.57 95%CI 2.44-5.23 for brachytherapy and OR 1.34, 95%CI 1.06-1.69 for combination surgery and radiotherapy) compared to those undergoing radical prostatectomy. Agreement in cT assignment ranged from kappa of 0.158 to 0.582. Stem word components in DRE notes associated with poorest level of agreement were "abnorm," "hard," "nodul" and those with highest level of agreement were terms "benign" and "smooth." CONCLUSIONS: Mode of diagnosis/subsequent treatment, and cancer characteristics were associated with cT documentation. Third party interpretation of clinical notes is problematic.

Quality Indicators for Global Benchmarking of Localized Prostate Cancer Management.

PURPOSE: We sought to develop a core set of clinical indicators to enable international benchmarking of localized prostate cancer management using data available in the TrueNTH Global Registry. MATERIALS AND METHODS: An international expert panel completed an online survey and participated in a face-to-face meeting. Participants included 3 urologists, 3 radiation oncologists, 2 psychologists, 1 medical oncologist, 1 nurse and 1 epidemiologist with prostate cancer expertise from a total of 7 countries. Current guidelines on prostate cancer treatment and potential quality indicators were identified from a literature review. These potential indicators were refined and developed through a modified Delphi process during which each panelist independently and repeatedly rated each indicator based on importance (satisfying the indicator demonstrated a provision of high quality care) and feasibility (the likelihood that data used to construct the indicator could be collected at a population level). The main outcome measure was items with panel agreement indicated by a disagreement index less 1, median importance 8.5 or greater and median feasibility 9 or greater. RESULTS: The expert panel endorsed 33 indicators. Seven of these 33 prostate cancer quality indicators assessed care relating to diagnosis, 7 assessed primary treatment, 1 assessed salvage treatment and 18 assessed health outcomes. CONCLUSIONS: We developed a set of quality indicators to measure prostate cancer care using numerous international evidence-based clinical guidelines. These indicators will be pilot tested in the TrueNTH Global Registry. Reports comparing indicator performance will subsequently be distributed to groups at participating sites with the purpose of improving the consistency and quality of prostate cancer management on a global basis.

Cohort profile: the TrueNTH Global Registry - an international registry to monitor and improve localised prostate cancer health outcomes.

PURPOSE: Globally, prostate cancer treatment and outcomes for men vary according to where they live, their race and the care they receive. The TrueNTH Global Registry project was established as an international registry monitoring care provided to men with localised prostate cancer (CaP). PARTICIPANTS: Sites with existing CaP databases in Movember fundraising countries were invited to participate in the international registry. In total, 25 Local Data Centres (LDCs) representing 113 participating sites across 13 countries have nominated to contribute to the project. It will collect a dataset based on the International Consortium for Health Outcome Measures (ICHOM) standardised dataset for localised CaP. FINDINGS TO DATE: A governance strategy has been developed to oversee registry operation, including transmission of reversibly anonymised data. LDCs are represented on the Project Steering Committee, reporting to an Executive Committee. A Project Coordination Centre and Data Coordination Centre (DCC) have been established. A project was undertaken to compare existing datasets, understand capacity at project commencement (baseline) to collect the ICHOM dataset and assist in determining the final data dictionary. 21/25 LDCs provided data dictionaries for review. Some ICHOM data fields were well collected (diagnosis, treatment start dates) and others poorly collected (complications, comorbidities). 17/94 (18%) ICHOM data fields were relegated to non-mandatory fields due to poor capture by most existing registries. Participating sites will transmit data through a web interface biannually to the DCC. FUTURE PLANS: Recruitment to the TrueNTH Global Registry-PCOR project will commence in late 2017 with sites progressively contributing reversibly anonymised data following ethical review in local regions. Researchers will have capacity to source deidentified data after the establishment phase. Quality indicators are to be established through a modified Delphi approach in later 2017, and it is anticipated that reports on performance against quality indicators will be provided to LDCs.

Population-based study of grade progression in patients who harboured Gleason 3 + 3.

PURPOSE: This study aimed to evaluate (1) the time interval between a decision to commence on active surveillance (AS) and grade progression in community practice; (2) factors predicting grade progression in localised prostate cancer (CaP) patients apparently undergoing AS. METHODS: Data from the Prostate Cancer Outcomes Registry-Victoria were used to analyze men with Gleason 3 + 3 CaP or less who had at least one repeat biopsy. Unadjusted and adjusted 5-year Kaplan-Meier survival curves were used to assess the time to grade progression. Both univariate and multivariate analyses for grade progression were performed using Cox proportional hazards. RESULTS: The cohort included 951 men. Overall, 39% of men had Gleason grade reclassified to a higher risk disease state with median of 2.2 years [IQR 1.2-3.7 years]. Men who harboured cT2 disease were 30% more likely to have upgrading compared to men with cT1 disease (adjusted HR: 1.3, 95% CI 1.0-1.6, p = 0.048). Half of the men with cT2 in our cohort had their Gleason grade reclassified within 1.6 years from diagnosis as compared with 2.7 years for the cT1 group. The presence of percentage of core involvement >25.0% and a PSA velocity of >1.01 ng/mL/year remained significant for a higher progression rate. The adjusted HR: 1.6; 95% CI [1.2-2.3], p = 0.004; adjusted HR: 1.6, 95% CI [1.2-2.4], p = 0.021, for percent of core involvement of 25.1-37.5%, and ≥37.6%, respectively. The adjusted HRs and p value associated with PSA velocity were 1.5; 95% CI [1.1-2.1], p = 0.016 and 1.6; 95% CI [1.2-2.3], p = 0.003 for PSA velocity values of 1.01-2 ng/mL per year and >2 ng/mL per year, respectively. Men who were diagnosed in regional hospital and subsequently had biopsy in metropolitan hospital were twice at risk of having Gleason upgrade compared to those whom both diagnostic and surveillance biopsies were carried out in metropolitan hospitals (adjusted HR: 1.9; 95% CI 1.1-3.3, p = 0.029). CONCLUSIONS: When placing men on AS and considering time to histologic progression, clinicians should pay particular attention to the likely accuracy of the diagnostic specimen, their tumour stage, volume of tumour (percent of core involvement), and rising PSA. Those diagnosed with T2 disease and had >25.0% of core involvement, and a PSA velocity greater than 1 ng/mL per year is at particular risk for more rapid disease progression and, for this reason, should be counselled on the importance of following the recommended surveillance regimen. For half of these men, their disease will have 'progressed' according to biopsy results in 2 years.

Study protocol of an equivalence randomized controlled trial to evaluate the effectiveness of three different approaches to collecting Patient Reported Outcome Measures (PROMs) data using the Prostate Cancer Outcomes Registry-Victoria (PCOR-VIC).

BACKGROUND: Patient-reported outcome measures (PROMs) are used by clinical quality registries to assess patients' perspectives of care outcomes and quality of life. PROMs can be assessed through a self-administered survey or by a third party. Use of mixed mode approaches where PROMs are completed using a single or combination of administration method is emerging. The aim of this study is to identify the most cost-effective efficient approach to collecting PROMs among three modes (telephone, postal service/mail and email) in a population-based clinical quality registry monitoring survivorship after a diagnosis of prostate cancer. This is important to assist the registry in achieving representative PROMs capture using the most cost-effective technique and in developing cost projections for national scale-up. METHODS/DESIGN: This study will adopt an equivalence randomised controlled design. Participants are men diagnosed with and/or treated for prostate cancer (PCa) participating in PCOR-VIC and meet the criteria for 12-month follow-up. Participants will be individually randomized to three independent groups: telephone, mail/postal, or email to complete the 26-item Expanded Prostate Cancer Index Composite (EPIC-26) survey. It is estimated each group will have 229 respondents. We will compare the proportion of completed surveys across the three groups. The economic evaluation will be undertaken from the perspective of the data collection centre and consider all operating costs (personnel, supplies, training, operation and maintenance). Cost data will be captured using an Activity Based Costs method. To estimate the most cost-effective approach, we will calculate incremental cost-effectiveness ratios. A cost projection model will be developed based on most cost-effective approach for nationwide scale-up of the PROMs tool for follow-up of PCa patients in Australia. DISCUSSION: This study will identify the most cost-effective approach for collecting PROMs from men with PCa, and enable estimation of costs for national implementation of the PCa PROMs survey. The findings will be of interest to other registries embarking on PROMs data collection. TRIAL REGISTRATION: ACTRN12615001369516 (Registered on December 16, 2015).

Diagnostic and treatment factors associated with poor survival from prostate cancer are differentially distributed between regional and metropolitan Victoria, Australia.

BACKGROUND: Men diagnosed with prostate cancer (PCa) in specific regional areas in Victoria, Australia have a poorer five-year survival rate compared to men living elsewhere in Victoria. This study aims to describe patterns-of- presentation and -care for men diagnosed with PCa in a specific regional Victorian area, and compare the outcomes with other Victorian regions. METHODS: Information on consecutive men diagnosed between 2008 and 2013 was extracted from the Prostate Cancer Outcomes Registry-Victoria. Descriptive analyses summarized diagnostic and treatment patterns of the 7,204 men with PCa in the selected region (n = 373), metropolitan Melbourne (n = 2,565) and remaining areas of Victoria (n = 4,266) to compare risk factors, treatments and time-taken-to-treatment. RESULTS: Men with PCa in the selected region were more likely to be diagnosed at older age (aged 68.6 vs 66 years in the rest of Victoria), and incidentally rather than through case-finding PSA blood tests. They were more likely to be presented with higher NCCN risk of the disease (High: 26 %, 24 % and 20.3 %; Very high/Metastasis: 11.8 %, 5.2 % and 5.7 % in the study region, metropolitan Melbourne and elsewhere in Victoria, respectively). Men in the selected region were also more likely to have a longer time from diagnosis to treatment (on average 15-30 days longer when compared to the rest of Victoria). CONCLUSIONS: Poorer outcomes of men with PCa in this specific region might be explained by multiple factors, including clinical-, patient-, and health-system-related. This range of explanatory factors, occurring at multiple points along the pathway of diagnosis and detection, suggests that interventions to improve outcomes for PCa in regional areas such as this need to be systematic. Interventions specifically addressing any one factor in isolation are unlikely to have much effect.

Quality of care achievements of the Prostate Cancer Outcomes Registry-Victoria.

OBJECTIVE: To analyse the performance of the quality of prostate cancer (CaP) care over a 5-year period with reference to three quality indicators (QIs) reported by the Prostate Cancer Outcomes Registry-Victoria (PCOR-Vic):QI-1: Alignment with the modified Prostate Cancer Research International Active Surveillance (PRIAS) protocol guideline;QI-2: Timeliness of CaP care for men with high risk and locally advanced disease;QI-3: Positive surgical margins (PSMs) for organ-confined pathological T2 disease. DESIGN, SETTING AND PARTICIPANTS: Between 1 January 2009 and 31 December 2013, 4708 men diagnosed with CaP who met the QI-1, QI-2 or QI-3 inclusion criteria were recruited from Victorian hospitals.Outcome measures and statistical analysis: Trend analysis was conducted to monitor performance according to QI-1, QI-2 and QI-3. We used the autoregressive integrated moving average (ARIMA) model to account for any inherent autocorrelation in the data when analysing the monthly incidence of each indicator. Differences in the annual figures for the indicators across years were also analysed by aggregating data by year and applying the ARIMA model. RESULTS AND LIMITATIONS: There was a downward trend over the 5 years in the percentage of men with low risk disease who underwent active treatment (45% to 34%; P = 0.024), an upward trend in the percentage of those with high risk and locally advanced disease who received active treatment within 12 months of diagnosis (88% to 93%; P = 0.181), and a decline in PSM rate in men with pathological T2 disease after radical prostatectomy (21% to 12%; P = 0.036). Limitations of the study include the fact that the improvement in the QIs was detected using PCOR-Vic as a single population, but there may be institutional variations in quality improvement. CONCLUSIONS: Over 2009-2013, the performance of the Victorian health system improved according to the three processes of care indicators reported by the PCOR-Vic.

Comparison of Patient-Reported Quality-of-Life and Complications in Men With Prostate Cancer, Between Two Modes of Administration.

INTRODUCTION: Our purpose was to: (1) assess the level of consistency between the quality-of-life (QOL) scores of men with prostate cancer for urinary/bowel/sexual bother, collected via telephone versus self-administered survey; (2) determine factors associated with variation in level of agreement; and (3) assess the efficacy of telephone interview as a mode of administration against the "gold standard" tool, EPIC-26. METHODS: Cohen's Kappa coefficients were calculated to investigate test-retest reliability across modes of administration. Logistic regression models explored patients' characteristics associated with the magnitude of urinary/bowel/sexual problem. Sensitivities and specificities of the telephone mode in reference to "gold standard" were further measured. RESULTS: From 221 men who agreed to participate in the study, 168 (76.0%) returned completed surveys. Kappa-linear model resulted in a moderate agreement across the urinary/bowel/sexual bother scores for both modes of administration; with greatest concordance recorded for bowel bother (90%). Patient's age (<75 years), disease risk, and active treatment type determined a moderate-to-good level of agreement between administration modalities with a Kappa varying between 0.44 and 0.73; χ(2), 8.18; P = .042. Sensitivity tests revealed that 68% of men with a moderate/big problem during the phone interviews would respond to suffering from a moderate/big sexual problem. CONCLUSION: Results of this pilot study revealed that QOL outcomes from this registry will likely underestimate the true bother experienced by men. More research is required to determine the differences between self-administered and telephone interviews in men with prostate cancer.