'It Just Makes Sense to Me': A qualitative study exploring patient decision-making and experiences with prostate MRI during active surveillance for prostate cancer.

Introduction: Although prostate magnetic resonance imaging (MRI) is commonly used in the diagnosis, staging and active surveillance of prostate cancer, little is known about patient perspectives on MRI. Methods: We performed a qualitative study consisting of in-depth, semi-structured interviews of patients with low- and intermediate-risk prostate cancer managed with active surveillance. Interviews focused on experiences with and knowledge of prostate MRI and MRI-ultrasound fusion biopsy during active surveillance. We purposively sampled patients who received prostate MRI as part of their clinical care, conducted interviews until reaching thematic saturation and performed conventional content analysis to analyse data. Results: Twenty patients aged 51-79 years (mean = 68 years) participated in the study. At diagnosis, 17 (85%) had a Gleason grade group 1, and three (15%) had a grade group 2 tumour. Overall, participants viewed prostate MRI as a valuable tool that accurately localizes and monitors prostate cancer over time, and they considered prostate MRI central to active surveillance monitoring. We identified five thematic categories related to MRI use: (1) the experiential aspects of undergoing an MRI scan; (2) the experience of visualizing one's own prostate and prostate cancer; (3) adequacy of provider explanations of MRI results; (4) confidence in prostate MRI in decision-making; and (5) the role of prostate MRI in longitudinal follow-up, including an interest in using MRI to modify the timing of, or replace, prostate biopsy. Conclusion: Patients value prostate MRI as a tool that enhances their confidence in the initial diagnosis and monitoring of prostate cancer. This work can inform future studies to optimize patient experience, education and counselling during active surveillance for prostate cancer.

Design of a pragmatic randomized implementation effectiveness trial testing a health system wide hypertension program for older adults.

Hypertension control remains poor. Multiple barriers at the level of patients, providers, and health systems interfere with implementation of hypertension guidelines and effective lowering of BP. Some strategies such as self-measured blood pressure (SMBP) and remote management by pharmacists are safe and effectively lower BP but have not been effectively implemented. In this study, we combine such evidence-based strategies to build a remote hypertension program and test its effectiveness and implementation in large health systems. This randomized, controlled, pragmatic type I hybrid implementation effectiveness trial will examine the virtual collaborative care clinic (vCCC), a hypertension program that integrates automated patient identification, SMBP, remote BP monitoring by trained health system pharmacists, and frequent patient-provider communication. We will randomize 1000 patients with uncontrolled hypertension from two large health systems in a 1:1 ratio to either vCCC or control (usual care with education) groups for a 2-year intervention. Outcome measures including BP measurements, cognitive function, and a symptom checklist will be completed during study visits. Other outcome measures of cardiovascular events, mortality, and health care utilization will be assessed using Medicare data. For the primary outcome of proportion achieving BP control (defined as systolic BP < 130 mmHg) in the two groups, we will use a generalized linear mixed model analysis. Implementation outcomes include acceptability and feasibility of the program. This study will guide implementation of a hypertension program within large health systems to effectively lower BP.

Determinants of targeted cancer therapy use in community oncology practice: a qualitative study using the Theoretical Domains Framework and Rummler-Brache process mapping.

BACKGROUND: Precision medicine holds enormous potential to improve outcomes for cancer patients, offering improved rates of cancer control and quality of life. Not all patients who could benefit from targeted cancer therapy receive it, and some who may not benefit do receive targeted therapy. We sought to comprehensively identify determinants of targeted therapy use among community oncology programs, where most cancer patients receive their care. METHODS: Guided by the Theoretical Domains Framework, we conducted semi-structured interviews with 24 community cancer care providers and mapped targeted therapy delivery across 11 cancer care delivery teams using a Rummler-Brache diagram. Transcripts were coded to the framework using template analysis, and inductive coding was used to identify key behaviors. Coding was revised until a consensus was reached. RESULTS: Intention to deliver precision medicine was high across all participants interviewed, who also reported untenable knowledge demands. We identified distinctly different teams, processes, and determinants for (1) genomic test ordering and (2) delivery of targeted therapies. A key determinant of molecular testing was role alignment. The dominant expectation for oncologists to order and interpret genomic tests is at odds with their role as treatment decision-makers' and pathologists' typical role to stage tumors. Programs in which pathologists considered genomic test ordering as part of their staging responsibilities reported high and timely testing rates. Determinants of treatment delivery were contingent on resources and ability to offset delivery costs, which low- volume programs could not do. Rural programs faced additional treatment delivery challenges. CONCLUSIONS: We identified novel determinants of targeted therapy delivery that potentially could be addressed through role re-alignment. Standardized, pathology-initiated genomic testing may prove fruitful in ensuring patients eligible for targeted therapy are identified, even if the care they need cannot be delivered at small and rural sites which may have distinct challenges in treatment delivery. Incorporating behavior specification and Rummler-Brache process mapping with determinant analysis may extend its usefulness beyond the identification of the need for contextual adaptation.

Implementing a home-based virtual hypertension programme-a pilot feasibility study.

INTRODUCTION: Implementing a health system-based hypertension programme may lower blood pressure (BP). METHODS: We performed a randomized, controlled pilot study to assess feasibility, acceptability, and safety of a home-based virtual hypertension programme integrating evidence-based strategies to overcome current barriers to BP control. Trained clinical pharmacists staffed the virtual collaborative care clinic (vCCC) to remotely manage hypertension using a BP dashboard and phone "visits" to monitor BP, adherence, side effects of medications, and prescribe anti-hypertensives. Patients with uncontrolled hypertension were identified via electronic health records. Enrolled patients were randomized to either vCCC or usual care for 3 months. We assessed patients' home BP monitoring behaviour, and patients', physicians', and pharmacists' perspectives on feasibility and acceptability of individual programme components. RESULTS: Thirty-one patients (vCCC = 17, usual care = 14) from six physician clinics completed the pilot study. After 3 months, average BP decreased in the vCCC arm (P = 0.01), but not in the control arm (P = 0.45). The vCCC participants measured BP more (9.9 vs. 1.2 per week, P < 0.001). There were no intervention-related adverse events. Participating physicians (n = 6), pharmacists (n = 5), and patients (n = 31) rated all programme components with average scores of >4.0, a pre-specified benchmark. Nine adaptations in vCCC design and delivery were made based on potential barriers to implementing the programme and suggestions. CONCLUSION: A home-based virtual hypertension programme using team-based care, technology, and a logical integration of evidence-based strategies is safe, acceptable, and feasible to intended users. These pilot data support studies to assess the effectiveness of this programme at a larger scale.

Access to urologists for participation in research: An analysis of NCI's Community Oncology Research Program landscape survey.

Purpose: Urological cancer clinical trials face accrual challenges, which may stem from structural barriers within cancer programs. We sought to describe the extent to which urology cancer care providers are available within community cancer research programs and explore the role of oncology practice group ownership in their access to urology practices to participate in research. Materials and methods: We conducted secondary analysis of organizational survey data collected in 2017 among National Cancer Institute Community Oncology Research Program practice groups. We used logistic regression to assess the association of self-reported access to urologists to participate in research and oncology practice group ownership type: independent, payor-provider, health-system, or public ownership. Results: Of the 209 community oncology practice groups in the analysis sample, 133 (63.6%) had access to urologists for research participation. Ownership was not statistically significantly associated with access to urology practices after controlling for other covariates (p = 0.4). Instead, having a hospital outpatient clinic (p = 0.008) and identifying as a safety-net hospital (p = 0.035) were both positively significantly associated with access to urologists to participate in research. Conclusions: Two-thirds of community cancer research groups have access to urology. Oncology ownership status was not associated with access to urologists for research. Research groups may need support to increase their capacity to engage non-oncology cancer care providers in research.

Geographic differences in community oncology provider and practice location characteristics in the central United States.

PURPOSE: How care delivery influences urban-rural disparities in cancer outcomes is unclear. We sought to understand community oncologists' practice settings to inform cancer care delivery interventions. METHODS: We conducted secondary analysis of a national dataset of providers billing Medicare from June 1, 2019 to May 31, 2020 in 13 states in the central United States. We used Kruskal-Wallis rank and Fisher's exact tests to compare physician characteristics and practice settings among rural and urban community oncologists. FINDINGS: We identified 1,963 oncologists practicing in 1,492 community locations; 67.5% practiced in exclusively urban locations, 11.3% in exclusively rural locations, and 21.1% in both rural and urban locations. Rural-only, urban-only, and urban-rural spanning oncologists practice in an average of 1.6, 2.4, and 5.1 different locations, respectively. A higher proportion of rural community sites were solo practices (11.7% vs 4.0%, P<.001) or single specialty practices (16.4% vs 9.4%, P<.001); and had less diversity in training environments (86.5% vs 67.8% with <2 medical schools represented, P<.001) than urban community sites. Rural multispecialty group sites were less likely to include other cancer specialists. CONCLUSIONS: We identified 2 potentially distinct styles of care delivery in rural communities, which may require distinct interventions: (1) innovation-isolated rural oncologists, who are more likely to be solo providers, provide care at few locations, and practice with doctors with similar training experiences; and (2) urban-rural spanning oncologists who provide care at a high number of locations and have potential to spread innovation, but may face high complexity and limited opportunity for care standardization.

Direct primary care: Family physician perceptions of a growing model.

INTRODUCTION: Direct Primary Care (DPC) is a relatively new primary care practice model in which patients receive unlimited access to a defined set of primary care services in exchange for a monthly practice-specific membership fee. DPC is a bottom-up physician-driven approach in contrast to typical top-down insurer-centric healthcare delivery reform efforts. The degree to which physicians are aware of this practice model and whether they believe it addresses two key challenges facing primary care, access and administrative burden, are unclear. METHODS: An online survey was distributed in July 2017 to 672 members of a research marketing sample of the American Academy of Family Physicians (n=225; response rate 33%). Based on AAFP definitions, the survey consisted of both open- and close-ended questions that gauged family physicians' awareness of DPC, as well as their perceptions about the model. RESULTS: Most respondents (85%) had heard of DPC and 8% practised in a DPC model at the time of the survey. In general, respondents reported that DPC can offer positive outcomes through lower administrative burden for physicians, improved doctor-patient relationships, and better access. Respondents also suggested DPC may result in improved patient health outcomes and lower overall healthcare spending. Respondents' concerns included inappropriateness of the model for vulnerable populations and physician shortages. Survey responses differed depending on whether the respondent practised in a DPC model. DPC physicians had a more favorable view of the model and were focused on benefits to patients rather than benefits to physicians. CONCLUSIONS: Any changes to practice models will require a better understanding of clear definitions of practice models. Further education is required about the specific benefits to vulnerable patients and practice standards. As the perceptions of DPC vary by practice experience, DPC physicians appear to be strong potential advocates of the model.

Physician perceived barriers and facilitators for self-measured blood pressure monitoring- a qualitative study.

INTRODUCTION: Improving hypertension management is a national priority that can decrease morbidity and mortality. Evidence-based hypertension management guidelines advocate self-measured BP (SMBP), but widespread implementation of SMBP is lacking. The purpose of this study was to describe the perspective of primary care physicians (PCPs) on SMBP to identify the barriers and facilitators for implementing SMBP. METHODS: We collected data from PCPs from a large health system using semi-structured interviews based on the Theoretical Domains Framework (TDF). Responses were recorded, transcribed, and qualitatively analyzed into three overarching TDF domains based on the Behavior Change Wheel (BCW): 1) Motivation 2) Opportunity and 3) Capabilities. The sample size was based on theme saturation. RESULTS: All 17 participating PCPs believed that SMBP is a useful, but underutilized tool. Although individual practices varied, most physicians felt that the increased data points from SMBP allowed for better hypertension management. Most felt that overcoming existing barriers would be difficult, but identified several facilitators: physician support of SMBP, the possibility of having other trained health professionals to assist with SMBP and patient education; improving patient engagement and empowerment with SMBP, and the interest of the health system in using technology to improve hypertension management. CONCLUSION: PCPs believe that SMBP can improve hypertension management. There are numerous barriers and facilitators for implementing SMBP. Successful implementation in clinical practice will require implementation strategies targeted at increasing patient acceptability and reducing physician workload. This may need a radical change in the current methods of managing hypertension.

Factors associated with utilization of neoadjuvant chemotherapy in charlson comorbidity zero non-metastatic muscle-invasive bladder cancer patients

ABSTRACT Background: Guideline-based best practice treatment for muscle invasive bladder cancer (MIBC) involves neoadjuvant chemotherapy followed by radical cystectomy (NACRC). Prior studies have shown that a minority of patients receive NACRC and older age and renal function are drivers of non-receipt of NACRC. This study investigates treatment rates and factors associated with not receiving NACRC in MIBC patients with lower comorbidity status most likely to be candidates for NACRC. Materials and Methods: Retrospective United States National Cancer Database analysis from 2006 to 2015 of MIBC patients with Charlson comorbidity index (CCI) of zero. Analysis of NACRC treatment trends in higher CCI patients was also performed. Results: 15.561 MIBC patients met inclusion criteria. 1.507 (9.7%) received NACRC within 9 months of diagnosis. NACRC increased over time (15.0% in 2015 compared to 3.6% in 2006). Higher NACRC was noted in females, cT3 or cT4 cancer, later year of diagnosis, and academic facility treatment. Lower utilization was noted for blacks and NACRC decreased with increasing age and CCI. Only 16.9% of patients aged 23-62 in the lowest age quartile with muscle invasive bladder cancer and CCI of 0 received NACRC. Conclusions: Although utilization is increasing, receipt of NACRC remains low even in populations most likely to be candidates. Further study should continue to elucidate barriers to utilization of NACRC.

Perceived barriers to the adoption of active surveillance in low-risk prostate cancer: a qualitative analysis of community and academic urologists.

BACKGROUND: Clinical practice guidelines recommend active surveillance as the preferred treatment option for low-risk prostate cancer, but only a minority of eligible men receive active surveillance, and practice variation is substantial. The aim of this study is to describe barriers to urologists' recommendation of active surveillance in low-risk prostate cancer and explore variation of barriers by setting. METHODS: We conducted semi-structured interviews among 22 practicing urologists, evenly distributed between academic and community practice. We coded barriers to active surveillance according to a conceptual model of determinants of treatment quality to identify potential opportunities for intervention. RESULTS: Community and academic urologists were generally in agreement on factors influencing active surveillance. Urologists perceived patient-level factors to have the greatest influence on recommendations, particularly tumor pathology, patient age, and judgements about the patient's ability to adhere to follow-up protocols. They also noted cross-cutting clinical barriers, including concerns about the adequacy of biopsy samples, inconsistent protocols to guide active surveillance, and side effects of biopsy procedures. Urologists had differing opinions on the impact of environmental factors, such as financial disincentives and fear of litigation. CONCLUSIONS: Despite national and international recommendations, both academic and community urologists note a variety of barriers to implementing active surveillance in low risk prostate cancer. These barriers will need to be specifically addressed in efforts to help urologists offer active surveillance more consistently.

Factors associated with utilization of neoadjuvant chemotherapy in charlson comorbidity zero non-metastatic muscle-invasive bladder cancer patients.

BACKGROUND: Guideline-based best practice treatment for muscle invasive bladder cancer (MIBC) involves neoadjuvant chemotherapy followed by radical cystectomy (NACRC). Prior studies have shown that a minority of patients receive NACRC and older age and renal function are drivers of non-receipt of NACRC. This study investigates treatment rates and factors associated with not receiving NACRC in MIBC patients with lower comorbidity status most likely to be candidates for NACRC. MATERIALS AND METHODS: Retrospective United States National Cancer Database analysis from 2006 to 2015 of MIBC patients with Charlson comorbidity index (CCI) of zero. Analysis of NACRC treatment trends in higher CCI patients was also performed. RESULTS: 15.561 MIBC patients met inclusion criteria. 1.507 (9.7%) received NACRC within 9 months of diagnosis. NACRC increased over time (15.0% in 2015 compared to 3.6% in 2006). Higher NACRC was noted in females, cT3 or cT4 cancer, later year of diagnosis, and academic facility treatment. Lower utilization was noted for blacks and NACRC decreased with increasing age and CCI. Only 16.9% of patients aged 23-62 in the lowest age quartile with muscle invasive bladder cancer and CCI of 0 received NACRC. CONCLUSIONS: Although utilization is increasing, receipt of NACRC remains low even in populations most likely to be candidates. Further study should continue to elucidate barriers to utilization of NACRC.

Use of implementation science in tobacco control intervention studies in the USA between 2000 and 2020: a scoping review protocol.

INTRODUCTION: Despite continuing efforts to reduce tobacco use in the USA, decline in smoking rates have stalled and smoking remains a major contributor to preventable death. Implementation science could potentially improve uptake and impact of evidence-based tobacco control interventions; however, no previous studies have systematically examined how implementation science has been used in this field. Our scoping review will describe the use of implementation science in tobacco control in the USA, identify relevant gaps in research and suggest future directions for implementation science application to tobacco control. METHODS AND ANALYSIS: Our team, including a medical research librarian, will conduct a scoping review guided primarily by Arksey and O'Malley's methodology. We will search English language peer-reviewed literature published from 2000 to 31 December 2020 for terms synonymous with 'tobacco use', 'prevention', 'cessation' and 'implementation science'. The databases included in this search are MEDLINE (PubMed), Embase (Ovid), CINAHL (EBSCOhost), PsycINFO (ProQuest), ERIC (ProQuest) and the Cochrane Library (Wiley). We will include cohort and quasi-experimental studies, single-group experiments and randomised trials that report qualitative and/or quantitative data related to applying implementation science to the planning and/or delivery of interventions to prevent or decrease the use of tobacco products. Studies must target potential or active tobacco users, intervention providers such as educators or healthcare professionals, or US policy-makers. A minimum of two reviewers will independently examine each title and abstract for relevance, and each eligible full text for inclusion and analysis. Use of implementation science, demonstrated by explicit reference to implementation frameworks, strategies or outcomes, will be extracted from included studies and summarised. ETHICS AND DISSEMINATION: This study is exempt from ethics board approval. We will document the equity-orientation of included studies with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Equity Extension checklist. Results will be submitted for conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBER: Open Science Framework Registry (6YRK8).

Using Implementation Science to Further the Adoption and Implementation of Advance Care Planning in Rural Primary Care.

PURPOSE: To analyze the literature on advance care planning (ACP) in primary care through the lens of implementation science, with a focus on implications for rural settings. DESIGN: Scoping review of the literature. METHODS: The Cumulative Index of Nursing and Allied Health Literature (CINAHL), Medline, PsycINFO, and the Psychology and Behavioral Sciences Collection databases were searched for studies related to ACP adoption and implementation in primary care. The Theoretical Domains Framework was used to map the literature to 14 determinants that serve as barriers or facilitators to ACP. The Conceptual Model of Evidence-Based Practice Implementation in Public Service Sectors was used to analyze the stage of implementation for each of the included studies. FINDINGS: Four steps to ACP were specified: identification, conversation, documentation, and follow-up. Determinants were identified for each step, but studies largely focused on the conversation step. Professional role and identity, environmental context and resources, and emotion were the most frequently cited determinants in initiating conversations. The identification step was largely determined by behavioral regulation. For documenting ACP, environmental context and resource determinants were most prevalent. In the few studies that addressed follow-up, providers expressed a desire for electronic reminders as a behavioral regulator to follow-up. CONCLUSIONS: While ACP has been shown to have patient, family, and societal benefits, its uptake in primary care has been minimal. Because ACP is a complex process that is highly context dependent, implementation science is critical to inform its successful adoption and implementation. Smaller healthcare networks, adaptable professional roles, trusted relationships, and tight-knit community might be important facilitators of ACP in rural primary care. CLINICAL RELEVANCE: Findings from this study can be used to accelerate ACP implementation in rural primary care.

Development, acceptability, appropriateness and appeal of a cancer clinical trials implementation intervention for rural- and minority-serving urology practices.

BACKGROUND: Few community urologists offer cancer patients the opportunity to participate in cancer clinical trials, despite national guidelines that recommend it, depriving an estimated 260,000 urological cancer patients of guideline-concordant care each year. Existing strategies to increase urologists' offer of clinical trials are designed for resource-rich environments and are not feasible for many community urologists. We sought to design an implementation intervention for dissemination in under-resourced community urology practices and to compare its acceptability, appropriateness and adoption appeal among trial-naïve and trial-experienced urologists. METHODS: We used a design-for-dissemination approach, informed by the Theoretical Domains Framework and Behavior Change Wheel, to match determinants of the clinical trial offer to theoretically informed implementation strategies. We described the implementation intervention in evaluation workshops offered at urology professional society meetings. We surveyed participants to assess the implementation intervention's acceptability and appropriateness using validated instruments. We also measured adoption appeal, intention to adopt and previous trial offer. RESULTS: Our design process resulted in a multi-modal implementation intervention, comprised of multiple implementation strategies designed to address six domains from the Theoretical Domains Framework. Evaluation workshops delivered at four meetings, convened five separate professional societies. Sixty-one percent of those offered an opportunity to participate in the implementation intervention indicated intention to adopt. Average implementation intervention acceptability and appropriateness ratings were 4.4 and 4.4 (out of 5), respectively. Acceptability scores were statistically significantly higher among those offering trials compared to those not (p = 0.03). Appropriateness scores did not differ between those offering trials and those not (p = 0.24). After urologists ranked their top three innovation attributes, 43% of urologists included practice reputation in their top three reasons for offering clinical trials; 30% listed practice differentiation among their top three reasons. No statistically significant differences were found between those who offered trials and those who did not among any of the innovation attributes. CONCLUSIONS: LEARN|INFORM|RECRUIT is a promising implementation intervention to address low accrual to clinical trials, poised for implementation and effectiveness testing. The implementation intervention is appealing to its target audience and may have equal uptake among trial-naïve and trial-experienced practices.

Science in the Heartland: Exploring determinants of offering cancer clinical trials in rural-serving community urology practices.

OBJECTIVE: Engaging community urologists in referring patients to clinical trials could increase the reach of cancer trials and, ultimately, alleviate cancer disparities. We sought to identify determinants of referring patients to clinical trials among urology practices serving rural communities. METHODS: We conducted semistructured qualitative interviews based on the Theoretical Domains Framework at nonmetropolitan urology practices located in communities offering urological cancer trials. Participants were asked to consider barriers and strategies that might support engaging their patients in discussions about urological cancer clinical trials and referring them appropriately. Recorded interviews were transcribed and coded using template analysis. RESULTS: Most participants were not aware of available trials and had no experience with trial referral. Overall, participants held positive attitudes toward clinical trials and recognized their potential roles in accrual, but limited local resources reduced opportunities for offering trials. Most participants expressed a need for increased human, financial, and other resources to support this role. Many participants requested information and training to increase their knowledge of clinical trials and confidence in offering them to patients. Participants highlighted the need to build efficient pathways to identify available trials, match eligible patients, and facilitate communication and collaboration with cancer centers for patient follow-up and continuity of care. CONCLUSIONS: With adequate logistical and informational support, community urology practices could play an important role in clinical trial accrual, advancing cancer research and increasing treatment options for rural cancer patients. Future studies should explore the effectiveness of strategies to optimize urology practices' role in clinical trial accrual.

Four Needles in a Haystack: A Systematic Review Assessing Quality of Health Care in Specialty Practice by Practice Type.

Specialists, who represent 60% of physicians in the United States, are consolidating into large group practices, but the degree to which group practice type facilitates the delivery of high quality of care in specialty settings is unknown. We conducted a systematic literature review to identify the impact of group practice type on the quality of care among specialty providers. The search resulted in 913 articles, of which only 4 met inclusion criteria. Studies were of moderate methodological quality. From the limited evidence available, we hypothesize that solo specialists deliver care that is inferior to their peers in group practice, whether measured by patient satisfaction ratings or adherence to guideline-based care. However, solo specialists and multidisciplinary group specialists may be more likely to provide some specialized services compared with their single-specialty group peers. Insufficient research compares quality of care among different practice types in specialty care. Substantial opportunity exists to test the degree to which organizational factors, whether size of practice or the mix of providers within the practice, influence quality of care in specialty settings.

Patient Factors That Influence How Physicians Discuss Active Surveillance With Low-Risk Prostate Cancer Patients: A Qualitative Study.

For men diagnosed with prostate cancer, making treatment decisions can be overwhelming. Navigating treatment options, along with potential treatment side effects, can be difficult, and patients often rely heavily on the advice of their physicians. This study was aimed at understanding more about the way urologists talk with their patients about one treatment option: active surveillance (AS), a recognized management strategy for men with low-risk prostate cancer that includes close observation and monitoring of the cancer. This study reports, through 22 interviews with urologists, that urologists believe patients are hesitant about AS for a number of reasons, including misperceptions about cancer severity, anxiety, aversion to repeated biopsies that accompany AS, or family member preferences. Because urologists play an influential role in educating patients about treatment options, the discussion around AS can be impacted by barriers that physicians believe matter for their patients. Improving awareness among urologists about what factors impact their patient education about low-risk prostate cancer is important. Identifying tools to improve shared decision making in this area could result in treatment decisions that are increasingly concordant with patients' values, concerns, and goals.

Insurance denials for cancer clinical trial participation after the Affordable Care Act mandate.

BACKGROUND: The Affordable Care Act (ACA) includes a mandate requiring most private health insurers to cover routine patient care costs for cancer clinical trial participation; however, the impact of this provision on cancer centers' efforts to accrue patients to clinical trials has not been well described. METHODS: First, members of cancer research centers and community-based institutions (n = 252) were surveyed to assess the status of insurance denials, and then, a focused survey (n = 77) collected denial details. Univariate and multivariate analyses were used to examine associations between the receipt of denials and site characteristics. RESULTS: Overall, 62.7% of the initial survey respondents reported at least 1 insurance denial during 2014. Sites using a precertification process were 3.04 times more likely to experience denials (95% confidence interval, 1.55-5.99; P ≤ .001), and similar rates of denials were reported from sites located in states with preexisting clinical trial coverage laws versus states without them (82.3% vs 85.1%; χ = 50.7; P ≤ .001). Among the focused survey sites, academic centers reported denials more often than community sites (71.4% vs 46.4%). The failure of plans to cover trial participation was cited as the most common reason provided for denials (n = 33 [80.5%]), with nearly 80% of sites (n = 61) not receiving a coverage response from the insurer within 72 hours. CONCLUSIONS: Despite the ACA's mandate for most insurers to cover routine care costs for cancer clinical trial participation, denials and delays continue. Denials may continue because some insurers remain exempt from the law, or they may signal an implementation failure. Delays in coverage may affect patient participation in trials. Additional efforts to eliminate this barrier will be needed to achieve federal initiatives to double the pace of cancer research over the next 5 years. Future work should assess the law's effectiveness at the patient level to inform these efforts. Cancer 2017;123:2893-900. © 2017 American Cancer Society.

Are Small Reimbursement Changes Enough to Change Cancer Care? Reimbursement Variation in Prostate Cancer Treatment.

PURPOSE: The Centers for Medicare and Medicaid Services recently initiated small reimbursement adjustments to improve the value of care delivered under fee-for-service. To estimate the degree to which reimbursement influences physician decision making, we examined utilization of gonadotropin-releasing hormone (GnRH) agonists among urologists as Part B drug reimbursement varied in a fee-for-service environment. METHODS: We analyzed treatment patterns of urologists treating 15,128 men included in SEER-linked Medicare claims who were diagnosed with localized prostate cancer between January 1, 2000, and December 31, 2003. We calculated a reimbursement generosity index to measure differences in GnRH agonist reimbursement among regional Medicare carriers and over time. We used multilevel analysis to control for patient and provider characteristics. RESULTS: Among urologists treating early-stage and lower grade prostate cancer, variation in reimbursement was not associated with overuse of GnRH agonists from 2000 to 2003, a period of guideline stability (odds ratio, 1.00; 95% CI, 0.99 to 1.00). CONCLUSION: Small differences in androgen-deprivation therapy reimbursement generosity were not associated with differential use. Fee-for-service reimbursement changes currently being implemented to improve quality in fee-for-service Medicare may not affect patterns of cancer care.

An ensemble-based Cox proportional hazards regression framework for predicting survival in metastatic castration-resistant prostate cancer (mCRPC) patients.

From March through August 2015, nearly 60 teams from around the world participated in the Prostate Cancer Dream Challenge (PCDC). Participating teams were faced with the task of developing prediction models for patient survival and treatment discontinuation using baseline clinical variables collected on metastatic castrate-resistant prostate cancer (mCRPC) patients in the comparator arm of four phase III clinical trials. In total, over 2,000 mCRPC patients treated with first-line docetaxel comprised the training and testing data sets used in this challenge. In this paper we describe: (a) the sub-challenges comprising the PCDC, (b) the statistical metrics used to benchmark prediction performance, (c) our analytical approach, and finally (d) our team's overall performance in this challenge. Specifically, we discuss our curated, ad-hoc, feature selection (CAFS) strategy for identifying clinically important risk-predictors, the ensemble-based Cox proportional hazards regression framework used in our final submission, and the adaptation of our modeling framework based on the results from the intermittent leaderboard rounds. Strong predictors of patient survival were successfully identified utilizing our model building approach. Several of the identified predictors were new features created by our team via strategically merging collections of weak predictors. In each of the three intermittent leaderboard rounds, our prediction models scored among the top four models across all participating teams and our final submission ranked 9 th place overall with an integrated area under the curve (iAUC) of 0.7711 computed in an independent test set. While the prediction performance of teams placing between 2 nd- 10 th (iAUC: 0.7710-0.7789) was better than the current gold-standard prediction model for prostate cancer survival, the top-performing team, FIMM-UTU significantly outperformed all other contestants with an iAUC of 0.7915.  In summary, our ensemble-based Cox regression framework with CAFS resulted in strong overall performance for predicting prostate cancer survival and represents a promising approach for future prediction problems.