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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.

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.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.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% with2 medical schools represented, P.001) than urban community sites. Rural multispecialty group sites were less likely to include other cancer specialists.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.

Background Precision medicine has enormous potential to improve cancer outcomes. Over one third of the 1.5 million Americans diagnosed with cancer each year have genetic mutations that could be targeted with an FDA-approved drug to treat their disease more effectively. However, the current uptake of targeted cancer therapy in clinical practice is suboptimal. Tumor testing is not widely used, and treatments based on molecular and genomic profiling are often not prescribed when indicated. Challenges with the uptake of precision medicine may disproportionately impact cancer patients in rural communities and other underserved populations. The objective of this study is to identify the determinants of adoption and implementation of precision cancer therapy to design an implementation strategy for community oncology practices, including those in rural areas. Methods This study is an explanatory sequential mixed methods study to identify factors associated with the use of targeted cancer therapy. Levels of targeted therapy use will be ascertained by secondary analysis of medical records to identify concordance with 18 national guideline recommendations for use of precision medicine in the treatment of breast, colorectal, lung, and melanoma skin cancer. Concurrently, facilitators and barriers associated with the use of precision cancer therapy will be elicited from interviews with up to a total of 40 oncologists, administrators, pathology, and pharmacy staff across the participating sites. Qualitative analysis will be a template analysis based on the Theoretical Domains Framework. Quantitative data aggregated at the practice level will be used to rank oncology practices’ adherence to targeted cancer therapy guidelines. Determinants will be compared among high and low users to isolate factors likely to facilitate targeted therapy use. The study will be conducted in eight community oncology practices, with an estimated 4121 targeted therapy treatment decision-making opportunities over a 3-year period. Discussion Despite unprecedented investment in precision medicine, translation into practice is suboptimal. Our study will identify factors associated with the uptake of precision medicine in community settings. These findings will inform future interventions to increase equitable uptake of evidence-based targeted cancer treatment.

BackgroundPrecision 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.MethodsGuided 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 consensus was reached.ResultsWe identified distinctly different processes and determinants for 1) somatic and molecular testing and 2) delivery of targeted therapies. Although motivation and intention to offer genomic testing and targeted therapies were high, professional roles and identities were challenged across targeted therapy delivery. Community oncologists’ role as generalist providers was threatened by the knowledge demands of genomic testing. Further oncologists’ role in testing was inconsistent with not only their more traditional role as treatment decision maker, but also pathologists’ role to comprehensively stage tumors. In addition, new roles were emerging or intensifying in the pathology and treatment teams to manage orders from reference laboratories and to ensure patients had access to costly therapies. Professional society guidance and greater institutional standardization were desired for testing, test reporting, and treatment protocols. Benefits for testing (preventing harms and avoiding costs) and treatment (better outcomes, but long-term use without cure) were different and may impact commitment to each behavior differentially.ConclusionsIntervention strategies that address tumor testing and treatment as distinct behaviors with unique determinants may offer promising implementation strategies to improve cancer care delivery as the processes fall to different cancer care delivery teams. Coupling process mapping with determinant analysis may improve the quality of determinant analyses and the subsequent implementation interventions proposed.Trial Registrationn/a

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.

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.

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.Trial Registration: N/A

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[2] = 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.

BackgroundFew 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.MethodsWe 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.ResultsOur 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.ConclusionsLEARN|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.

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.

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.

IntroductionDespite 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 analysisOur 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 disseminationThis 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 numberOpen Science Framework Registry (6YRK8).

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.

Medicare reimbursement cuts have been associated with declining gonadotropin-releasing hormone (GnRH) agonist overuse in localized prostate cancer. Medical school affiliation and foreign training have been associated with persistent overuse. However, physician-level prescribing changes and the practice type of persistent overusers have not been examined. We sought to describe physician-level changes in GnRH agonist overuse and test the association of time in practice and solo practice type with GnRH agonist overuse. We matched American Medical Association physician data for 2138 urologists to Surveillance, Epidemiology and End Result-Medicare data for 12 943 men diagnosed with early-stage and lower-grade adenocarcinoma of the prostate between 2000 and 2007. We conducted a population-based, retrospective study using multilevel modeling to control for patient and provider characteristics. Three distinct patterns of GnRH agonist overuse were observed. Urologists’ time in practice was not associated with GnRH agonist overuse (odds ratio (OR) 0.89; 95% confidence interval (CI): 0.75–1.05). However, solo practice type (OR 1.65; 95% CI: 1.34–2.02), medical school affiliation (OR 0.65; 95% CI: 0.55–0.77) and patient race were. Compared with non-Hispanic whites, non-Hispanic blacks (OR 1.76; 95% CI: 1.37–2.27), Hispanics (OR 1.41; 95% CI: 1.12–1.79) and men of ‘other’ race (OR 1.44; 95% CI: 1.04–1.99) had greater odds of receiving unnecessary GnRH agonists. GnRH agonist overuse remains high among some urologists who may be professionally isolated and difficult to reach. These urologists treat more vulnerable populations, which may contribute to health disparities in prostate cancer treatment quality. Nonetheless, these findings provide guidance to develop interventions to address overuse in prostate cancer.

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.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.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.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.

Domestic violence (DV) affects approximately 25% of women in the United States with approximately 5.3 million incidents each year. DV advocates and national medical associations encourage health care providers (HCPs) to screen patients. To determine DV screening rates by race and income, patient race/ethnicity, income, and receipt of and receptiveness toward screening were measured. Patient preference for screening did not vary by race and varied little by income, but experience with screening did. Practices serving predominantly African American and lower income patients screened at higher rates. These findings seem driven by practice factors rather than differential treatment of individuals. Future research should focus on why certain types of practices screen more than others.

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.

The authors describe the conceptualization, development, implementation and refinement of a faith community-based initiative to train clergy and lay leaders to respond appropriately to domestic violence within faith communities, to strengthen ties to local secular providers of DV services, and to promote effective prevention, identification, intervention, and treatment of domestic violence in congregations throughout the Winston-Salem, NC area. Results from focus groups conducted with program participants are presented, along with lesson learned and recommendations for future efforts.

"Physicians-recruiting-physicians" is the preferred recruitment approach for practice-based research. However, yields are variable; and the approach can be costly and lead to biased, unrepresentative samples. We sought to explore the potential efficiency of alternative methods.We conducted a retrospective analysis of the yield and cost of 10 recruitment strategies used to recruit primary care practices to a randomized trial to improve cardiovascular disease risk factor management. We measured response and recruitment yields and the resources used to estimate the value of each strategy. Providers at recruited practices were surveyed about motivation for participation.Response to 6 opt-in marketing strategies was 0.40% (53/13290), ranging from 0% to 2.86% by strategy; 33.96% (18/53) of responders were recruited to the study. Of those recruited from opt-out strategies, 8.68% joined the study, ranging from 5.35% to 41.67% per strategy. A strategy that combined both opt-in and opt-out approaches resulted in a 51.14% (90/176) response and a 10.80% (19/90) recruitment rate. Cost of recruitment was $613 per recruited practice. Recruitment approaches based on in-person meetings (41.67%), previous relationships (33.33%), and borrowing an Area Health Education Center's established networks (10.80%), yielded the most recruited practices per effort and were most cost efficient. Individual providers who chose to participate were motivated by interest in improving their clinical practice (80.5%); contributing to CVD primary prevention (54.4%); and invigorating their practice with new ideas (42.1%).This analysis provides suggestions for future recruitment efforts and research. Translational studies with limited funds could consider multi-modal recruitment approaches including in-person presentations to practice groups and exploitation of previous relationships, which require the providers to opt-out, and interactive opt-in approaches which rely on borrowed networks. These approaches can be supplemented with non-relationship-based opt-out strategies such as cold calls strategically targeted to underrepresented provider groups.

Purpose: Genetic screening can enable timely detection and treatment of hereditary hemochromatosis (HH). Little is known about patient acceptability of DNA testing as compared to conventional phenotypic testing. Methods: Within the HEIRS Study, a large primary-care screening study of HH and iron overload, we randomly assigned participants to receive brief information on either HH genotypic or phenotypic testing, and assessed the willingness to accept this test. The study was designed to recruit an equal number of African Americans and Caucasians. Results: A total of 2500 participants were recruited from waiting rooms of primary care practices; 2165 participants who self-identified as African Americans and Caucasians were included in the analyses. Overall, 56% had accepted a genotypic test versus 58% for a phenotypic test. Adjusting for Field Center (FC), age, gender, race, educational attainment, global health rating, and knowledge of the test, the odds ratio of accepting a genotypic versus phenotypic test was 0.85 (95% CI: 0.71, 1.02; P = 0.078). Characteristics associated with test acceptance were age 45–64 years, female gender, Caucasian race, self-rated health less than “very good”, and knowledge of the test. Test acceptance was associated with interest in knowing more about health (81%) and in helping family members (71%). Refusal reasons included a need to talk with a doctor (44%), concern about privacy (32%), and dislike of blood drawing (29%). Conclusion: In this diverse sample of primary care patients, stated acceptance of genotypic testing for HH mutations was similar to phenotypic testing for blood iron. Patient education regarding the nature of test, importance of disease detection, and privacy protection appear to be essential for achieving high rates of screening participation.

Purpose: Fear of genetic discrimination might deter participation in research or therapy. This is a major impetus for laws limiting insurers' use of genetic information, yet there is little information about the extent of this fear in the general population and how it varies by social factors. Methods: This study measures concern about insurance problems relating to genetic testing, as part of primary-care screening for hereditary hemochromatosis (iron overload). Data come from a multiethnic, primary care–based survey of 86,859 adults in five field centers in the United States (AL, CA, DC, HI, OR), and one in Canada (Ontario). Logistic regression was used to model the probability of agreeing to the question “Genetic testing is not a good idea because you might have trouble getting or keeping your insurance.” Results: Overall, 40.0% of participants agreed. Adjusting for other characteristics, African Americans and Asians were much less likely (OR = 0.52 and 0.39), and Hispanics were more likely (OR = 1.124), than Caucasians to express concern about insurance discrimination. Participants under 65 years old, US residents, and those without a high school diploma were substantially more likely to be concerned (ORs ranging from 1.4–1.6), as were participants with lower mental health scores. Education showed a nonlinear relationship, with significantly higher concern among both those with less than a high school education and those with a college degree, compared to high school graduates. Conclusions: Concern about genetic discrimination varies substantially by race and other demographic factors and by nationality. One possible explanation for lower concern about Canadians and by people over 64 is that both groups are covered by social insurance for health care (Medicare). However, US residents in states with some legal protections against genetic discrimination had more, not less, concern than either Canadians or US residents in states with no legal protections.

In February 2008, the US Food and Drug Administration (FDA) granted accelerated approval for bevacizumab for metastatic breast cancer. After public hearings in July 2010, and June 2011, the FDA revoked this approved indication in November 2011, on the basis of additional evidence regarding its risk/benefit profile. The Centers for Medicare and Medicaid Services, local Medicare contractors, and commercial payers varied in their stated intentions to cover bevacizumab after FDA's regulatory actions. We examined payer-specific trends in bevacizumab use after the FDA's regulatory actions.We used outpatient medical claims compiled by IMS Health to evaluate trends in bevacizumab use for breast cancer for Medicare-insured and commercially insured patients (N = 102,906) using segmented regression. Given that Medicare coverage policies may vary across regional contractors, we estimated trends in bevacizumab use across 10 local coverage areas. In a sensitivity analysis, we estimated trends in bevacizumab use for breast cancer compared with trends in use for lung cancer using difference-in-differences models.Among chemotherapy infusions for breast cancer, bevacizumab use decreased from 31% in July 2010, to 4% in September 2012. Use decreased by 11% among commercially insured and 13% among Medicare-insured patients after July 2010 (interaction P = .68) and continued to decline by 9% per month (interaction P = .61). We observed no contractor-level variation in bevacizumab use among Medicare beneficiaries. During the same period, bevacizumab use for lung cancer was stable.Although insurers varied in public statements regarding coverage intentions, bevacizumab use declined similarly among all payers, suggesting that provider decision making, rather than payer-specific coverage policies, drove reductions.

The complexity of adherence to pharmacological interventions is frequently underestimated. Consequently, little research has been done to understand, improve, or evaluate the effects of adherence to drug protocols. While efforts to better measure and increase adherence require dedicated resources, improved adherence in existing clinical research can potentially cut costs in trial size and length. This paper outlines strategies to facilitate research on adherence to pharmacological interventions including: reporting of adherence data, changing how we conceptualize adherence to pharmaceuticals, understanding issues unique to older adults' pill-taking behavior, and creating standardized methodologies to measure adherence. Further, we describe some promising research areas that may lead to effective interventions: adherence "typologies" and modality matching. Control Clin Trials 2000;21:218S-225S

The reliable and valid assessment of health-related quality of life (HRQoL) in human immunodeficiency virus (HIV) clinical research presents both familiar and unique challenges. Consistent with HRQoL research in general, measures of HRQoL in HIV disease must meet a set of standard psychometric properties, produce interpretable results, and be responsive to relatively small treatment effects. Furthermore, as clinical research for a range of diseases and conditions becomes increasingly global, HRQoL investigators are confronted with the formidable task of developing measures that are applicable across a range of cultures and languages within and across national boundaries. In this paper, we present a model of HRQoL to be applied across diseases and conditions, with a discussion of the key measurement issues. We then briefly consider the natural history and treatment aspects of HIV that are relevant to HRQoL research. In the final sections of the paper, we describe the elements needed in an 'ideal' HRQoL/HIV instrument and propose a method for evaluating the degree to which current HRQoL measures address the challenges posed by HIV clinical research.

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 9th 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 2nd- 10th (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.

e16618Background: Management of low-risk prostate cancer with active surveillance (AS) has increased, but AS is still underused. We sought to identify whether urologists' perceptions of barriers va...

e14047Background: A recent federal initiative, the Cancer Moonshot, to develop and complete randomized clinical trials in four years for tens of thousands of US cancer patients may face a hurdle. A...

Thirty-five U.S. states and territories have implemented policies requiring insurers to cover patient care costs in the context of cancer clinical trials; however, evidence of the effectiveness of these policies is limited. This study assesses the impact of state insurance mandates on clinical trial accrual among community-based practices participating in the NCI Community Clinical Oncology Program (CCOP), which enrolls approximately one-third of all NCI cancer trial participants. We analyzed CCOP clinical trial enrollment over 17 years in 37 states, 14 of which implemented coverage policies, using fixed effects least squares regression to estimate the effect of state policies on trial accrual among community providers, controlling for state and CCOP differences in capacity to recruit. Of 91 CCOPs active during this time, 28 were directly affected by coverage mandates. Average recruitment per CCOP between 1991 and 2007 was 95.1 participants per year (SD = 55.8). CCOPs in states with a mandate recruited similar numbers of participants compared to states without a mandate. In multivariable analysis, treatment trial accrual among CCOPs in states that had implemented a coverage mandate, was not statistically different than accrual among CCOPs in states that did not implement a coverage mandate (β = 2.95, p = 0.681). State mandates did not appear to confer a benefit in terms of CCOP clinical trial accrual. State policies vary in strength, which may have diluted their effect on accrual. Nonetheless, policy mandates alone may not have a meaningful impact on participation in clinical trials in these states.

The Personal Digital Assistance for Guideline Adherence (GLAD Heart) study was designed to test a strategy to improve quality of care through increased adherence to ATPIII cholesterol guidelines. This paper describes the overall study design including the multi-faceted intervention and outcome measures. Sixty-one primary care practices in NC were recruited and randomized to either a personal digital assistant-based cholesterol management intervention or an intervention similar in intensity and frequency of contact but focused on a hypertension clinical practice guideline. Installation and implementation of the technology intervention was challenging. Over the course of the study, there were 74 technical issues requiring assistance for the palm pilot from 23 participating practices. The GLAD Heart project was completed successfully with some impact on cholesterol management. Technology has the potential to improve the quality of care provided in the healthcare setting. However, potentially expensive interventions such as that conducted in GLAD Heart should undergo rigorous testing to assure their efficacy before widespread adoption.

The purpose of this study was to assess the level of satisfaction and understanding of test results, by a sample of non-C282Y homozygous participants in the hemochromatosis and iron overload screening (HEIRS) study, who received serum ferritin (SF), transferrin saturation (TS), and HFE gene test results by mail.Approximately 1 month after receiving test results by mail, participants were surveyed about understanding of and satisfaction with results notification.Overall, participants were satisfied with receiving test results by mail. Participants receiving results with one or two HFE mutations or TS and/or SF levels outside the normal range (an "alert value") were less likely to be satisfied with this method of notification. Participants with normal HFE test results understood their results and recommendations better than those with one or two mutations. Although all participants received results letters in their native language, English-speaking participants had higher mean understanding scores than Mandarin, Vietnamese, or Spanish-speaking participants.Participants were satisfied with receiving test results by mail. However, the level of understanding of the results was not sufficient for this mode of results notification to stand alone, especially for non-English speaking participants, and all participants with one or more test results outside the normal range.

Physician organizations recommend screening for health care behaviors. Despite these recommendations, health care providers worry that questions on sensitive topics may not be accepted by their patients. To determine if there is a relationship between health care screening by providers and acceptance of that screening by patients, a survey of female patients was analyzed.Two telephone surveys were conducted two years apart. Each was a cross-sectional sample of female patients over the age of 18 years who had been seen by their primary care provider (PCP) in the previous 12 months. Patients were asked if they had been screened for eight different health behaviors (exercise, smoking, use of alcohol or drugs, excessive stress, sexual functioning concerns, safety or violence in the home, guns in the home) in the past year. They were also asked about their attitudes toward screening for those behaviors by health care providers. Odds ratios were calculated for patients who both agreed that screening should occur and reported having been screened in the last year.3,175 women were surveyed. There was high acceptance of routine screening for exercise (75%), smoking (72%), alcohol/drugs (68%), and stress (62%), but less for sexual functioning (40%), safety/violence (40%), or guns (23%). There was a higher likelihood of agreeing with routine screening if the patient reported having been screened in the past year: exercise (OR 2.3, 95% CI 1.8-2.9), smoking (OR 1.6, 95% CI 1.3-1.9), alcohol/drugs (OR 2.3, 95% CI 1.9-2.7), stress (OR 1.7, 95% CI 1.4-1.9), sexual functioning (OR 2.7, 95% CI 2.2-3.4), safety/violence (OR 3.4, 95% CI 2.8-4.2), and guns (OR 4.4, 95% CI 3.4-5.8).Only women in established relationships with primary care providers were surveyed. The cross-sectional nature of the survey prevents determination of the causality of the relationship.Women who had been screened for a health behavior had greater acceptance of routine screening for that behavior. Although further research is needed to determine the casual relationship, providers should not worry about offending their patients when screening for sensitive health behaviors.

Background Interventions to change practice patterns among health care professionals have had mixed success. We tested the effectiveness of a practice centered intervention to increase screening for domestic violence in primary care practices. Methods A multifaceted intervention was conducted among primary care practice in North Carolina. All practices designated two individuals to serve as domestic violence resources persons, underwent initial training on screening for domestic violence, and participated in 3 lunch and learn sessions. Within this framework, practices selected the screening instrument, patient educational material, and content best suited for their environment. Effectiveness was evaluated using a pre/post cross-sectional telephone survey of a random selection of female patients from each practice. Results Seventeen practices were recruited and fifteen completed the study. Baseline screening for domestic violence was 16% with a range of 2% to 49%. An absolute increase in screening of 10% was achieved (range of increase 0 to 22%). After controlling for clustering by practice and other patient characteristics, female patients were 79% more likely to have been screened after the intervention (OR 1.79, 95% CI 1.43–2.23). Conclusion An intervention that allowed practices to tailor certain aspects to fit their needs increased screening for domestic violence. Further studies testing this technique using other outcomes are needed.

6565 Background: The benefit of bisphosphonate drugs in adjuvant breast cancer care has been a topic of clinical debate. A recently presented meta-analysis of clinical trials by Coleman et al (2013...

5044 Background: Reimbursement cuts driven by the Medicare Modernization Act of 2003 are associated with declining androgen deprivation therapy (ADT) overuse in prostate cancer; yet, 25.7% of men for whom ADT was not recommended still received it in 2005. We examined physician-level prescribing changes and characteristics of persistent overusers among urologists. Understanding characteristics of urologists who persistently overuse ADT can improve quality of care and inform current efforts to limit reimbursement. Methods: We conducted a population-based, retrospective study of 2,138 urologists treating 12,943 men with early stage and lower grade prostate cancer diagnosed between 2000 and 2007. SEER-Medicare data was matched to American Medical Association physician data. Mixed effects regression modeling controlled for patient and provider characteristics. Results: We observed 3 distinct patterns of overuse. Static users (69%) had low levels of ADT overuse in 2000 and maintained infrequent overuse. Decreas...

e16021 Background: Androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonists was widely used for primary treatment of localized prostate cancer in the 1990s and is now ...

Objective: To characterize the ED utilization patterns of the elderly population using nationally representative data. Methods: A secondary analysis was performed using the National Hospital Ambulatory Medical Care Survey (NHAMCS), a nationwide, stratified probability sample of ED encounters. Using these physician-reported data, the demographics, patient complaints, physician diagnoses, and dispositions were compared by age group, i.e., young-old (age 65–84 years) vs old-old (age ±85 years). Results: The elderly (age ±65 years) represented 5,038 (19.6%) of 25,646 ED encounters for all adults (age ±18 years). The geriatric age groups (ages 65–74, 75–84, and ±85 years) accounted for 45.3%, 37.4%, and 17.2% of all the encounters by the elderly. The proportions of female patients and white patients were higher with increasing age. The proportion of elderly patients hospitalized was 4 times that of younger adults and reflected monotonic increase with increasing age among elders. Patient complaints and physician diagnoses were generally similar for the young-old (65–84 years) and the old-old (±85 years). Conclusions: These findings are consistent with previous single-center studies of geriatric ED patients. This data source may be useful for investigation of clinical issues related to the care of elderly ED patients.

Background Survivorship care plans are intended to improve coordination of care for the nearly 14 million cancer survivors in the United States. Evidence suggests that survivorship care plans (SCPs) have positive outcomes for survivors, health-care professionals, and cancer programs, and several high-profile organizations now recommend SCP use. Nevertheless, SCP use remains limited among health-care professionals in United States cancer programs. Knowledge of barriers to SCP use is limited in part because extant studies have used anecdotal evidence to identify determinants. This study uses the theoretical domains framework to identify relevant constructs that are potential determinants of SCP use among United States health-care professionals. Methods We conducted semi-structured interviews to assess the relevance of 12 theoretical domains in predicting SCP use among 13 health-care professionals in 7 cancer programs throughout the United States with diverse characteristics. Relevant theoretical domains were identified through thematic coding of interview transcripts, identification of specific beliefs within coded text units, and mapping of specific beliefs onto theoretical constructs. Results We found the following theoretical domains (based on specific beliefs) to be potential determinants of SCP use: health-care professionals’ beliefs about the consequences of SCP use (benefit to survivors, health-care professionals, and the system as a whole); motivation and goals regarding SCP use (advocating SCP use; extent to which using SCPs competed for health-care professionals’ time); environmental context and resources (whether SCPs were delivered at a dedicated visit and whether a system, information technology, and funding facilitated SCP use); and social influences (whether using SCPs is an organizational priority, influential people support SCP use, and people who could assist with SCP use buy into using SCPs). Specific beliefs mapped onto the following psychological constructs: outcome expectancies, intrinsic motivation, goal priority, resources, leadership, and team working. Conclusions Previous studies have explored a limited range of determinants of SCP use. Our findings suggest a more comprehensive list of potential determinants that could be leveraged to promote SCP use. These results are particularly timely as cancer programs face impending SCP use requirements. Future work should develop instruments to measure the potential determinants and assess their relative influence on SCP use. Electronic supplementary material The online version of this article (doi:10.1186/s13012-014-0167-z) contains supplementary material, which is available to authorized users.

Background Survivorship care plans (SCPs) are written treatment summaries and follow-up care plans that are intended to facilitate communication and coordination of care among survivors, cancer care providers, and primary care providers. A growing number of guidelines for the use of SCPs exist, yet SCP use in the United States remains limited. Limited use of SCPs may be due to poor quality of these guidelines. The purpose of the study was to evaluate the quality of guidelines for SCP use, tools that are intended to promote evidence-based medicine. Methods We conducted a comprehensive search of the literature using MEDLINE/PubMed, EMBASE (Excerpta Medica Database), and CINAHL (Cumulative Index to Nursing and Allied Health Literature) published through April 2014, in addition to grey literature sources and bibliographic and expert reviews. Guideline quality was assessed using the AGREE II instrument (Appraisal of Guidelines for Research and Evaluation, 2nd edition), a tool developed by an international group of scientists to advance the quality of clinical practice guidelines. To promote consistency with extant studies using the AGREE II instrument and to clearly and unambiguously identify potentially useful guidelines for SCP use, we also summarized AGREE II scores by strongly recommending, recommending, or not recommending the guidelines that we evaluated. Results Of 128 documents screened, we included 16 guidelines for evaluation. We did not strongly recommend any of the 16 guidelines that we evaluated; we recommended 5 and we did not recommend 11. Overall, guidelines scored highest on clarity of presentation (i.e., guideline language, structure, and format): Guidelines were generally unambiguous in their recommendations that SCPs should be used. Guidelines scored lowest on applicability (i.e., barriers and facilitators to implementation, implementation strategies, and resource implications of applying the guideline): Few guidelines discussed facilitators and barriers to guideline application; advice and tools for implementing guidelines were vague; and none explicitly discussed resource implications of implementing the guidelines. Conclusions Guidelines often advocated survivorship care plan use without justification or suggestions for implementation. Improved guideline quality may promote survivorship care plan use. Electronic supplementary material The online version of this article (doi:10.1186/s13012-015-0254-9) contains supplementary material, which is available to authorized users.