Surgical wait list management in Canada during a pandemic: many challenges ahead.

Summary: The coronavirus disease 2019 (COVID-19) pandemic has had a massive impact on waits for elective operations, with tens of thousands of scheduled surgeries being cancelled or postponed across Canada. Provincial governments will likely not only reopen elective surgical capacity when it is deemed safe, but also target new funding to address the backlog of cases. There is a dearth of research on whether the provinces' approaches to managing wait lists are equitable from a patients' needs perspective or if they are associated with patients' perception of outcomes. The surgical cost models used in the past won't be useful to governments and hospital managers. New models based on hospitals' marginal costs, associated with running on weekends or off-hours and social distancing parameters, will be needed. Surgeon input, collaboration and leadership during the strategy development, implementation and management of surgical wait lists postpandemic will be imperative, as these decisions will significantly affect the health and lives of many Canadians.

Parent Preferences Regarding Home Oxygen Use for Infants with Bronchopulmonary Dysplasia.

OBJECTIVES: To determine parent preferences for discharge with home oxygen in infants with bronchopulmonary dysplasia. STUDY DESIGN: This was a prospective study of parents of infants born at <32 weeks' gestation with established bronchopulmonary dysplasia and approaching neonatal intensive care unit (NICU) discharge. Parents were presented a hypothetical scenario of an infant who failed weaning to room air and 2 options: discharge with home oxygen or try longer to wean oxygen. The initial scenario risks reflected a 1.5-week difference in NICU length of stay and no differences in other outcomes. Length of stay and readmission outcomes were increased or decreased until the parent switched preference. Three months after discharge, parents were asked to reconsider their preference. Differences were analyzed by χ2 or Kruskal-Wallis tests. RESULTS: Of 125 parents, 50% preferred home oxygen. For parents preferring home oxygen, the most important reason was comfort at home (79%). Forty percent switched preference when the length of stay difference decreased by 1 week; 35% switched when readmission increased by 5%. For parents preferring to stay in NICU, the most important reason was fear of taking care of the child at home (73%). Thirty-two percent switched preference when the length of stay difference increased by 1 week; 31% switched when readmission decreased by 5%. One hundred ten parents completed the 3-month follow-up; 80 were discharged with home oxygen. Seventy-eight percent would prefer home oxygen (97% who initially preferred home oxygen and 60% who initially preferred to stay in the NICU). CONCLUSIONS: Parents weigh differences in NICU length of stay and readmission risk similarly. After discharge, most prefer earlier discharge with home oxygen. Earlier education to increase comfort with home technology may facilitate NICU discharge planning.

Psychometric validation of the Stoma-QOL questionnaire in a Canadian cross-sectional sample of colostomy and ileostomy patients.

OBJECTIVES: The Stoma-QOL questionnaire is a patient-reported outcome (PRO) used to measure quality of life in patients with ileostomy or colostomy. This study assesses the Stoma-QOL's overall and item-level psychometric characteristics in patients with temporary stomas, and whether stoma-related quality of life differs by demographic characteristics. MATERIALS AND METHODS: Analysis of cross-sectional observational PRO data from hospitals in Vancouver, Canada. Patients registered for elective ileostomy or colostomy closure, over the age of 18, and able to read English were eligible for participation. Emergent and cancer-related cases were excluded. One-way analysis of variance was used to test for demographic differences in Stoma-QOL scores. Cronbach's alpha was used for reliability, and Rasch item-response theory was used to assess overall and item characteristics. RESULTS: 120 patients were included. No statistically significant difference in Stoma-QOL scores was found by age, sex, or socioeconomic status. Reliability was 0.93. Mean item responses ranged from 1.77 to 3.55 and item-total correlation ranged from 0.51 to 0.77. The Rasch item-response theory model demonstrated significant misfit, likely due to the misfit of item 9, which asks about sexuality, and high residual correlations between item pairs 6 and 8 about fatigue, and items 16 and 17 about social relationships. CONCLUSIONS: The Stoma-QOL questionnaire is a well-designed PRO for measuring stoma-related quality of life. Demographic variables do not appear to have a strong influence on Stoma-QOL scores. Item 9 demonstrated misfit but removal likely does not improve the instrument. Future research should focus on revising items 6, 8, 16, and 17.

Evaluating the 8-item overactive bladder questionnaire (OAB-v8) using item response theory.

AIMS: The OAB-v8 is a patient-reported outcome questionnaire used to screen for overactive bladder and measure symptom bother. This study uses modern validation methods to assess the item and test characteristics of the OAB-v8, and determine whether it should be scored differently for men and women. METHODS: A secondary analysis of data from patients with lower urinary tract symptoms prospectively recruited from a urology clinic in Calgary, Canada. Item-response theory (IRT) was used to evaluate the dimensionality, reliability, and validity of the OAB-v8, and differential functioning analysis (DIF) was used to determine whether the OAB-v8 should be scored differently for men and women. RESULTS: A total of 1128 patients were included for analysis, of which 28% were female. Mean OAB-v8 scores indicated meaningful levels of symptom bother, and women scored 2 points higher, on average, than men (P = 0.005). Reliability was high (Cronbach's alpha = 0.901) for a wide range of patients (between -2 and 2.5 standard deviations of the mean). Samejima's graded response model best fit the data, and the scale demonstrated essential unidimensionality. Items #5 and #6 were excessively correlated. There was no evidence of differential functioning. CONCLUSIONS: OAB-v8 demonstrated high reliability and would be appropriate for a wide range of patients. Items #5 and #6 may need to be re-worded. The OAB-v8 should not be scored differently for men and women, although women do appear to experience higher average levels of symptom bother from OAB than men.

Evaluation of the Fecal Incontinence Quality of Life Scale (FIQL) using item response theory reveals limitations and suggests revisions.

PURPOSE: The Fecal Incontinence Quality of Life Scale (FIQL) is a commonly used patient-reported outcome measure for fecal incontinence, often used in clinical trials, yet has not been validated in English since its initial development. This study uses modern methods to thoroughly evaluate the psychometric characteristics of the FIQL and its potential for differential functioning by gender. METHODS: This study analyzed prospectively collected patient-reported outcome data from a sample of patients prior to colorectal surgery. Patients were recruited from 14 general and colorectal surgeons in Vancouver Coastal Health hospitals in Vancouver, Canada. Confirmatory factor analysis was used to assess construct validity. Item response theory was used to evaluate test reliability, describe item-level characteristics, identify local item dependence, and test for differential functioning by gender. RESULTS: 236 patients were included for analysis, with mean age 58 and approximately half female. Factor analysis failed to identify the lifestyle, coping, depression, and embarrassment domains, suggesting lack of construct validity. Items demonstrated low difficulty, indicating that the test has the highest reliability among individuals who have low quality of life. Five items are suggested for removal or replacement. Differential test functioning was minimal. CONCLUSIONS: This study has identified specific improvements that can be made to each domain of the Fecal Incontinence Quality of Life Scale and to the instrument overall. Formatting, scoring, and instructions may be simplified, and items with higher difficulty developed. The lifestyle domain can be used as is. The embarrassment domain should be significantly revised before use.

Testing the feasibility of eliciting preferences for health states from adolescents using direct methods.

BACKGROUND: Measuring adolescents' preferences for health states can play an important role in evaluating the delivery of pediatric healthcare. However, formal evaluation of the common direct preference elicitation methods for health states has not been done with adolescents. Therefore, the purpose of this study is to test how these methods perform in terms of their feasibility, reliability, and validity for measuring health state preferences in adolescents. METHODS: This study used a web-based survey of adolescents, 18 years of age or younger, living in the United States. The survey included four health states, each comprised of six attributes. Preferences for these health states were elicited using the visual analogue scale, time trade-off, and standard gamble. The feasibility, test-retest reliability, and construct validity of each of these preference elicitation methods were tested and compared. RESULTS: A total of 144 participants were included in this study. Using a web-based survey format to elicit preferences for health states from adolescents was feasible. A majority of participants completed all three elicitation methods, ranked those methods as being easy, with very few requiring assistance from someone else. However, all three elicitation methods demonstrated weak test-retest reliability, with Kendall's tau-a values ranging from 0.204 to 0.402. Similarly, all three methods demonstrated poor construct validity, with 9-50% of all rankings aligning with our expectations. There were no significant differences across age groups. CONCLUSIONS: Using a web-based survey format to elicit preferences for health states from adolescents is feasible. However, the reliability and construct validity of the methods used to elicit these preferences when using this survey format are poor. Further research into the effects of a web-based survey approach to eliciting preferences for health states from adolescents is needed before health services researchers or pediatric clinicians widely employ these methods.

Case distribution and complications of mid-urethral sling surgery in a Canadian city before and after the Health Canada advisory on pelvic floor mesh.

INTRODUCTION AND HYPOTHESIS: Increased incidences of complications related to the use of mid-urethral slings (MUS) for the treatment of stress urinary incontinence resulted in both the Food and Drug Administration (FDA) and Health Canada issuing advisories in 2008 and 2010 respectively. The purpose of this study was to assess the effect these advisories had on the number of surgeons performing MUS surgery and post-surgical complications in Calgary, Canada. METHODS: In this study, we conducted a retrospective analysis of administrative data between 2006 and 2011. Post-surgical complications were identified using diagnostic codes. All rates were adjusted for the increase in the female population in Calgary during the study period. An interrupted time series model was used to evaluate any changes in the number of surgeons performing MUS surgery and any post-surgical changes from the period before and that after the advisories. RESULTS: The number of surgeons performing MUS surgery and the number of surgeries performed decreased over the study period, although neither of these was significantly related to the advisories. In terms of complications, we did not observe a significant change in the rate of repeat MUS surgeries, inpatient admissions, emergency department visits, or ambulatory care visits within 2 years of initial surgery. CONCLUSION: The FDA and Health Canada advisories had no effect on the use of MUS in Calgary. This suggests either that they bear little influence on local surgeons' practices, or that safety was already at such a high level that improvements were not possible.

Patient-reported outcomes and surgical triage: A gap in patient-centered care?

PURPOSE: To help address wait times for elective surgery, British Columbia has implemented a triaging system that assigns priority levels to patients based on their diagnoses. The extent to which these priority levels concords with patients' assessment of their health status is not known. The purpose of this study was to measure the association between the priority levels assigned to patients and their patient-reported outcomes data collected at the time of being enrolled on the surgical wait list. METHODS: Patients waiting for elective surgery in the Vancouver Coastal Health Authority were sampled. Participants completed a set of generic and condition-specific patient-reported outcome instruments, including: the EQ-5D(3L) (general health), PEG (pain), and the PHQ-9 (depression). A multivariate ordered logistic model was used to regress patient-reported outcome values on the priority level assigned at the time of wait list registration. RESULTS: A total of 2725 participants completed the survey package (response rate 49 %). Using the EQ-5D(3L), 63 % reported having problems with pain or discomfort, 41 % problems performing usual activities, 36 % problems with depression or anxiety, 28 % problems with mobility, and 8 % a problem with self-care. The results from the ordered logistic model indicated very little association between the patient-reported outcomes and wait list priority levels, when adjusted for patient factors. CONCLUSIONS: This study observed no relationship between patients' self-reported health status and their assigned priority level for elective surgery. A more patient-centered approach to triaging patients for surgical treatment would incorporate patients' perspective in surgical wait list prioritization systems.

Patient educational technologies and their use by patients diagnosed with localized prostate cancer.

BACKGROUND: Two urology practices in Calgary, Canada use patient educational technology (PET) as a core component of their clinical practice. The purpose of this study was to determine how patients interact with PET designed to inform them about their treatment options for clinically localized prostate cancer. METHODS: A PET library was developed with 15 unique prostate-related educational modules relating to diagnosis, treatment options, and potential side effects. The PET collected data regarding its use, and those data were used to conduct a retrospective analysis. Descriptive analyses were conducted and comparisons made between patients' utilization of the PET library during first and subsequent access; Pearson's Chi-Square was used to test for statistical significance, where appropriate. RESULTS: Every patient (n = 394) diagnosed with localized prostate cancer was given access to the PET library using a unique identifier. Of those, 123 logged into the library and viewed at least one module and 94 patients logged into the library more than once. The average patient initially viewed modules pertaining to their diagnosis. Viewing behavior significantly changed in subsequent logins, moving towards modules pertaining to treatment options, decision making, and post-surgical information. DISCUSSION: As observed through the longitudinal utilization of the PET library, information technology offers clinicians an opportunity to provide an interactive platform to meet patients' dynamic educational needs. Understanding these needs will help inform the development of more useful PETs. CONCLUSION: The informational needs of patients diagnosed with clinically localized prostate cancer changed throughout the course of their diagnosis and treatment.

Reforming Long-Term Care Funding in Alberta.

Like many provinces across Canada, Alberta is facing growing demand for long-term care. Issues with the mixed funding model used to pay long-term care providers had Alberta Health Services concerned that it was not efficiently meeting the demand for long-term care. Consequently, in 2010, Alberta Health Services introduced the patient/care-based funding (PCBF) model. PCBF is similar to activity-based funding in that it directly ties the complexity and care needs of long-term care residents to the payment received by long-term care providers. This review describes PCBF and discusses some of its strengths and weaknesses. In doing so, this review is intended to inform other provinces faced with similar long-term care challenges and contemplating their own funding reforms.

Advancing ocular oncology care through teleophthalmology: a patient-centric perspective.

OBJECTIVE: Assessing patient satisfaction is an important component of understanding a program's efficacy and quality. The purpose of this study is to evaluate patient satisfaction with a teleophthalmology program tailored for ocular oncology that provides screening, remote assessment, care planning, and follow-up. STUDY DESIGN: Retrospective survey. METHODS: An adapted version of the Telehealth Satisfaction Scale, consisting of the 8 questions plus 5 additional questions specific to the teleophthalmology program, was used to survey patients. The teleophthalmology program involves diagnostic imaging, remote physician assessments, and follow-up phone calls from health care team members to deliver results to patients. For reporting, the Consensus-Based Checklist for Reporting of Survey Studies was used. T-tests explored satisfaction differences across demographics and teleophthalmology visits. RESULTS: Among the 95 patients contacted, 91 agreed to participate in the survey (96% response rate). Participants exhibited high overall satisfaction with the teleophthalmology program, reflected in a mean Telehealth Satisfaction Scale score of 28.88 (SD = 3.35 of 32). The median number of teleophthalmology visits completed was 4.0 (range of 1-8 appointments). No significant differences in satisfaction were found on the basis of age (P = 0.56), urban or rural residence (P = 0.17), or the number of telemedicine appointments (P = 0.51). CONCLUSIONS: This analysis displays high satisfaction levels among patients within an ocular oncology clinic participating in the current telemedicine program, irrespective of age, geography, or number of teleophthalmology visits. Participants reported having their health care needs met with minimal clinical encounters due to remote consultations and telephone communications.

Artificial intelligence in the classification and segmentation of fundus images with choroidal nevi.

OBJECTIVE: The purpose of this study is to summarize the results from 3 experimental studies into the use of artificial intelligence to classify and segment colour fundus images with choroidal nevi. STUDY DESIGN: This study is based on a secondary analysis of colour fundus images taken of patients receiving usual clinical care from the Alberta Ocular Brachytherapy Program. METHODS: High-resolution colour fundus images were labeled by experienced ocular oncologists. In experimental study 1, four pre-trained models (ResNet 50, VGG-19, VGG-16, and AlexNet) were evaluated for their ability to classify images based on the presence of choroidal nevi. In experimental study 2, the performance of 3 patch-based models to classify images based on the presence of choroidal nevi were compared. In experimental study 3, four convolutional neural network models were developed to segment the images. In experimental studies 1 and 2, performance was measured using accuracy, precision, recall, F1 score, and AUC. In experimental study 3, IoU and Dice measures were used to evaluate performance. RESULTS: A total of 591 labelled colour fundus images were used for analysis. In experimental study 1, VGG-16 showed the best accuracy, AUC, and recall, but lower precision in classifying images. In experimental study 2, the patched approached enhanced with artifact and contrast outperformed the others in classifying images. In experimental study 3, a voting-based Ensemble model excelled in segmenting the part of images with nevi. CONCLUSIONS: It is feasible to train AI models to identify choroidal nevi in colour fundus images.

Psychometric Results of a New Patient-Reported Outcome Measure for Uveal Melanoma Post-Brachytherapy Treatment: The PROM-UM.

The objective of this study was to evaluate the psychometric properties of a new patient-reported outcome instrument intended for use with patients who have undergone brachytherapy for uveal melanoma (PROM-UM). Classical test theory and item response theory were used to evaluate the performance of individual items and domains. A convenience sample of 439 participants who had undergone brachytherapy for uveal melanoma from one of three North American ocular oncology treatment centers were included in this cross-sectional study. Exploratory factor analysis identified three domains which were labelled "Symptom Impairment", "Worry", and "Discomfort". The acceptability of the instrument was supported by little missing data (range = 0.00-1.14%) and low maximum endorsement (range = 0.00-1.82%). Item-total (range = 0.68-0.85) and inter-item (range = 0.74-0.80) correlations indicated acceptable reliability. Discrimination and difficulty were assessed using item response theory. Items in all three domains indicated moderate to very high discrimination (range = 1.00-4.10). Two items in the Symptom Impairment domain were too difficult to measure. Response ranges in the other two domains demonstrated acceptable difficulty. These results from the study indicate that this new patient-reported outcome instrument can be used with patients treated with brachytherapy for uveal melanoma. Providers could use this instrument to help inform post-treatment management.

Case mix-based changes in health status: A prospective study of elective surgery patients in Vancouver, Canada.

INTRODUCTION: Hospital activity is often measured using diagnosis-related groups, or case mix groups, but this information does not represent important aspects of patients' health outcomes. This study reports on case mix-based changes in health status of elective (planned) surgery patients in Vancouver, Canada. DATA AND METHODS: We used a prospectively recruited cohort of consecutive patients scheduled for planned inpatient or outpatient surgery in six acute care hospitals in Vancouver. All participants completed the EQ-5D(5L) preoperatively and 6 months postoperatively, collected from October 2015 to September 2020 and linked with hospital discharge data. The main outcome was whether patients' self-reported health status improved among different inpatient and outpatient case mix groups. RESULTS: The study included 1665 participants with completed EQ-5D(5L) preoperatively and postoperatively, representing a 44.8% participation rate across eight inpatient and outpatient surgical case mix categories. All case mix categories were associated with a statistically significant gain in health status (p < .01 or lower) as measured by the utility value and visual analogue scale score. Foot and ankle surgery patients had the lowest preoperative health status (mean utility value: 0.6103), while bariatric surgery patients reported the largest improvements in health status (mean gain in utility value: 0.1515). CONCLUSIONS: This study provides evidence that it was feasible to compare patient-reported outcomes across case mix categories of surgical patients in a consistent manner across a system of hospitals in one province in Canada. Reporting changes in health status of operative case mix categories identifies characteristics of patients more likely to experience significant gains in health.

Canadian cost data associated with treating overactive bladder is lacking.

INTRODUCTION: Cost-effectiveness analysis forms an integral part of the approval process for new medical treatments in Canada, including drug and non-drug technologies. This study's primary objective was to identify peer-reviewed studies that report Canadian-specific cost data for treating overactive bladder (OAB) based on the Canadian Urological Association (CUA) guideline. A secondary objective was to identify studies that report cost data from other healthcare jurisdictions that could be generalizable to the Canadian context. METHODS: We conducted a systematic review of the published peer-reviewed literature. We included studies from Organization for Economic Cooperation and Development countries, excluding the U.S., published in English since January 2009. RESULTS: From 165 abstracts identified in our initial search, 18 studies were ultimately included for analysis. This included one Canadian-based study reporting costs in Canadian dollars, all related to second-line treatments. The other studies were primarily from Europe, reporting costs in Euros or British pounds. There were no studies reporting costs for first-line treatments. Gaps in costs for select second-line and third-line treatments recommended by the CUA were also identified. CONCLUSIONS: Canadian-specific cost data for OAB treatments published in the peer-reviewed literature is limited to a single study reporting costs for only a few second-line treatments sourced from a single province over 10 years ago. Cost data from other healthcare jurisdictions are available, but the generalizability of costs associated with third-line treatments is questionable.

Prioritization and surgical wait lists: A cross-sectional survey of patient's health-related quality of life.

INTRODUCTION: In many countries, there are waits for elective (planned) surgery. In these settings, processes for triaging patients are applied to determine how long patients wait for their surgery. There are very few instances that evaluate the effectiveness of surgical triage processes. METHODS: A sample of patients from four acute care hospitals in Vancouver, Canada, completed a number of patient-reported outcomes shortly after being registered on the surgical wait list. Patients' diagnosis was used to triage and determine their expected wait for surgery. The associations between patient-reported outcomes with surgical triage were measured. RESULTS: The mean wait times for participants were similar across wait times categories. Participants whose expected waits for surgery were the longest reported successively lower levels of self-rated health (p < 0.01) and successively higher levels of pain (p < 0.01.) There was no difference in symptoms of anxiety among participants expected to wait the longest. DISCUSSION: The diagnosis-based system for prioritizing patients found higher levels of pain and lower health status among those expected to wait the longest for their surgery. Screening waiting patients for treatable mental health conditions should be implemented and the process of surgical triage could be redesigned to allow for a broader set of attributes of health to determine how long a patient waits for their elective surgery.

British Columbia hospitals: examination and assessment of payment reform (B-CHeaPR).

BACKGROUND: Accounting for 36% of public spending on health care in Canada, hospitals are a major target for cost reductions through various efficiency initiatives. Some provinces are considering payment reform as a vehicle to achieve this goal. With few exceptions, Canadian provinces have generally relied on global and line-item budgets to contain hospital costs. There is growing interest amongst policy-makers for using activity based funding (ABF) as means of creating financial incentives for hospitals to increase the 'volume' of care, reduce cost, discourage unnecessary activity, and encourage competition. British Columbia (B.C.) is the first province in Canada to implement ABF for partial reimbursement of acute hospitalization. To date, there have been no formal examinations of the effects of ABF policies in Canada. This study proposal addresses two research questions designed to determine whether ABF policies affect health system costs, access and hospital quality. The first question examines the impact of the hospital funding policy change on internal hospital activity based on expenditures and quality. The second question examines the impact of the change on non-hospital care, including readmission rates, amount of home care provided, and physician expenditures. METHODS/DESIGN: A longitudinal study design will be used, incorporating comprehensive population-based datasets of all B.C. residents; hospital, continuing care and physician services datasets will also be used. Data will be linked across sources using anonymized linking variables. Analytic datasets will be created for the period between 2005/2006 and 2012/2013. DISCUSSION: With Canadian hospitals unaccustomed to detailed scrutiny of what services are provided, to whom, and with what results, the move toward ABF is significant. This proposed study will provide evidence on the impacts of ABF, including changes in the type, volume, cost, and quality of services provided. Policy- and decision-makers in B.C. and elsewhere in Canada will be able to use this evidence as a basis for policy adaptations and modifications. The significance of this proposed study derives from the fact that the change in hospital funding policy has the potential to affect health system costs, residents' access to care and care quality.

The relationship between overactive bladder and prostate cancer: A scoping review.

INTRODUCTION: The relationship between prostate cancer (PCa) and overactive bladder (OAB) is poorly understood. PCa and OAB are frequently diagnosed in elderly populations, so it could be expected that both conditions would be observed in older patients. Whether PCa and OAB occur independently with age, or the presence of PCa leads to the onset of OAB/lower urinary tract symptoms (LUTS) has not been explored. This review aimed to investigate whether men newly diagnosed with PCa are more likely to have OAB compared to the general population, and if the various treatment modalities for PCa are likely to impact the incidence or exacerbation of OAB. METHODS: The University of Calgary's databases for Medline and PubMed were searched for relevant publications. No restrictions were placed on the study design reported. Any publications reporting OAB and a PCa diagnosis and/or observation relating to PCa diagnosis and rates of OAB/LUTS in an adult population were included for full review. RESULTS: Of the studies examining the relationship between PCa and LUTS, results varied, but frequently indicated an inverse association between PCa and LUTS in which patients newly diagnosed with PCa were more unlikely to have LUTS compared to the general population. Following treatment, brachytherapy resulted in a higher prevalence of OAB symptoms compared to surgical treatment and external beam radiation therapy. CONCLUSIONS: Diverse evidence was found regarding the relationship between the prevalence of pre-treatment OAB and PCa diagnosis. However, limited evidence, as well as uncertainty regarding pre-treatment symptoms and their impact on post-treatment outcomes, restricts potential conclusions.

Using the Movember Foundation's GAP3 cohort to measure the effect of active surveillance on patient-reported urinary and sexual function-a retrospective study in low-risk prostate cancer patients.

BACKGROUND: Active surveillance (AS) for low-risk prostate cancer (PCa) is intended to overcome potential side-effects of definitive treatment. Frequent prostate biopsies during AS may, however, impact erectile (EF) and urinary function (UF). The objective of this study was to test the influence of prostate biopsies on patient-reported EF and UF using multicenter data from the largest to-date AS-database. METHODS: In this retrospective study, data analyses were performed using the Movember GAP3 database (v3.2), containing data from 21,169 AS participants from 27 AS-cohorts worldwide. Participants were included in the study if they had at least one follow-up prostate biopsy and completed at least one patient reported outcome measure (PROM) related to EF [Sexual Health Inventory for Men (SHIM)/five item International Index of Erectile Function (IIEF-5)] or UF [International Prostate Symptom Score (IPSS)] during follow-up. The longitudinal effect of the number of biopsies on either SHIM/IIEF-5 or IPSS were analyzed using linear mixed models to adjust for clustering at patient-level. Analyses were stratified by center; covariates included age and Gleason Grade group at diagnosis, and time on AS. RESULTS: A total of 696 participants completed the SHIM/IIEF-5 3,175 times, with a median follow-up of 36 months [interquartile range (IQR) 20-55 months]. A total of 845 participants completed the IPSS 4,061 times, with a median follow-up of 35 months (IQR 19-56 months). The intraclass correlation (ICC) was 0.74 for the SHIM/IIEF-5 and 0.68 for the IPSS, indicating substantial differences between participants' PROMs. Limited heterogeneity between cohorts in the estimated effect of the number of biopsies on either PROM were observed. A significant association was observed between the number of biopsies and the SHIM/IIEF-5 score, but not for the IPSS score. Every biopsy was associated with a decrease in the SHIM/IIEF-5 score of an average 0.67 (95% CI, 0.47-0.88) points. CONCLUSIONS: Repeated prostate biopsy as part of an AS protocol for men with low-risk PCa does not have a significant association with self-reported UF but does impact self-reported sexual function. Further research is, however, needed to understand whether the effect on sexual function implies a negative clinical impact on their quality of life and is meaningful from a patient's perspective. In the meantime, clinicians and patients should anticipate a potential decline in erectile function and hence consider incorporating the risk of this harm into their discussion about opting for AS and also when deciding on the stringency of follow-up biopsy schedules with long-term AS.

Evaluating the measurement properties of the 26-item Expanded Prostate Cancer Index Composite (EPIC-26) with a multicenter cohort.

INTRODUCTION: We aimed to evaluate the psychometric properties of the 26-item Expanded Prostate Cancer Index Composite (EPIC-26) for measuring the quality of life in patients treated for localized prostate cancer. The EPIC-26 is a patient-reported outcome instrument recommended for use with patients treated for localized prostate cancer. METHODS: This study is based on data collected prospectively between September 2014 and February 2017 in Alberta, Canada. Men were treated with either radical prostatectomy or radiation therapy and administered the EPIC-26. Responses to the EPIC-26 were the primary outcome. Construct validity was measured using confirmatory factor analysis. Reliability was measured using Chronbach's alpha and item-total correlation. Ceiling and floor effects were also investigated. RESULTS: EPIC-26 response data from 205 participants (prostatectomy =138; radiation=60; both=7) were used in this analysis. The EPIC-26 was administered an average of 33.8 weeks after treatment. The confirmatory factor analysis model did not meet the threshold for adequate fit. Several items had near-zero factor loadings and were non-significant. Four out of the EPIC-26's five domains met the acceptable reliability threshold based on Cronbach's alpha. Ceiling effects were observed in four out of five domains. CONCLUSIONS: The EPIC-26 demonstrated poor construct validity, adequate reliability, and large ceiling effects. Several issues were observed, suggesting that the instrument's five domains were not well-defined by their respective items. The original EPIC's conceptual framework should be reviewed and the shortened instrument revised to improve its performance for measuring post-treatment quality of life.