Kentucky Outreach Service Kiosk (KyOSK) Study protocol: a community-level, controlled quasi-experimental, type 1 hybrid effectiveness study to assess implementation, effectiveness and cost-effectiveness of a community-tailored harm reduction kiosk on HIV, HCV and overdose risk in rural Appalachia.

INTRODUCTION: Many rural communities bear a disproportionate share of drug-related harms. Innovative harm reduction service models, such as vending machines or kiosks, can expand access to services that reduce drug-related harms. However, few kiosks operate in the USA, and their implementation, impact and cost-effectiveness have not been adequately evaluated in rural settings. This paper describes the Kentucky Outreach Service Kiosk (KyOSK) Study protocol to test the effectiveness, implementation outcomes and cost-effectiveness of a community-tailored, harm reduction kiosk in reducing HIV, hepatitis C and overdose risk in rural Appalachia. METHODS AND ANALYSIS: KyOSK is a community-level, controlled quasi-experimental, non-randomised trial. KyOSK involves two cohorts of people who use drugs, one in an intervention county (n=425) and one in a control county (n=325). People who are 18 years or older, are community-dwelling residents in the target counties and have used drugs to get high in the past 6 months are eligible. The trial compares the effectiveness of a fixed-site, staffed syringe service programme (standard of care) with the standard of care supplemented with a kiosk. The kiosk will contain various harm reduction supplies accessible to participants upon valid code entry, allowing dispensing data to be linked to participant survey data. The kiosk will include a call-back feature that allows participants to select needed services and receive linkage-to-care services from a peer recovery coach. The cohorts complete follow-up surveys every 6 months for 36 months (three preceding kiosk implementation and four post-implementation). The study will test the effectiveness of the kiosk on reducing risk behaviours associated with overdose, HIV and hepatitis C, as well as implementation outcomes and cost-effectiveness. ETHICS AND DISSEMINATION: The University of Kentucky Institutional Review Board approved the protocol. Results will be disseminated in academic conferences and peer-reviewed journals, online and print media, and community meetings. TRIAL REGISTRATION NUMBER: NCT05657106.

Acupuncture Reduces Severity of Hot Flashes in Breast Cancer: A Randomized Single-Blind Trial.

This study evaluated the effectiveness of traditional Chinese medicine-based therapeutic acupuncture (TA) in reducing the severity of hot flashes (HFs) in breast cancer patients and compared the effectiveness of TA to "sham" placebo acupuncture (SA). Subjects experiencing more than 10 episodes of HF/week were randomly assigned to TA or SA. The response was assessed by the Menopause-specific Quality of Life (MenQoL) scale, scoring the subject's perception of the severity of HFs. HFs were scored at baseline, after treatment, and 1-month follow-up. A total of 54 subjects enrolled (28 TA and 26 SA). Seven women withdrew from the study. A hot flash diary documented the number of HFs a subject experienced. Analysis included 47 subjects (27 TA and 20 SA). A statistically significant response in HF scores was noted in the TA group compared with the SA group (P = .0064.) On average HF scores dropped by 1.89 with TA, and only 0.16 with SA. At follow-up, TA subjects had a sustained response. TA is effective in reducing the intensity and severity of HF. With SA, no relative response/change in HF scores was noted. Larger studies and longer follow-up to assess durability of response to TA are needed.

Accessing Targeted Therapies: A Potential Roadblock to Implementing Precision Oncology?

PURPOSE: Advances in genomic techniques have led to increased use of next-generation sequencing (NGS). We evaluated the extent to which these tests guide treatment decisions. METHODS: We developed and distributed a survey assessing NGS use and outcomes to a survey pool of ASCO members. Comparisons between groups were performed with Wilcoxon two-sample, chi-square, and Fisher's exact tests. RESULTS: Among 178 respondents, 62% were male, 54% White, and 67% affiliated with academic centers. More than half (56%) indicated that NGS provided actionable information to a moderate or great extent. Use was highest (median ≥ 70% of cases) for lung and gastric cancer, and lowest (median < 25% of cases) in head and neck and genitourinary cancers. Approximately one third of respondents reported that, despite identification of an actionable molecular variant, patients were sometimes or often unable to access the relevant US Food and Drug Administration-approved therapy. When NGS did not provide actionable results, individuals reporting great or moderate guidance overall from NGS in treatment recommendations were more likely to request the compassionate use of an unapproved drug (P < .001), enroll on a clinical trial (P < .01), or treat off-label with a drug approved for another indication (P = .02). CONCLUSION: When NGS identifies an actionable result, a substantial proportion of clinicians reported encountering challenges obtaining approved therapies on the basis of these results. Perceived overall impact of NGS appears associated with clinical behavior unrelated to actionable NGS test results, including pursuing off-label or compassionate use of unapproved therapies or referring to a clinical trial.

Tumor Genomic Profiling Practices and Perceptions: A Survey of Physicians Participating in the NCI-MATCH Trial.

PURPOSE: To identify factors that may influence physician participation in tumor profiling studies and to assess the routine use of tumor profiling in clinical practice. METHODS: Physicians in the National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) were invited to participate in an electronic survey consisting of 73 questions related to participation in genomic profiling studies, tumor profiling practices and education during usual patient care, and physician background and practice characteristics. RESULTS: The survey response rate was 8.9% (171 surveys returned of 1,931 sent). A majority of respondents practiced in academic medical centers (AMCs). Participation in NCI-MATCH increased workload and cost but resulted in increased professional satisfaction, confidence in treatment recommendation, and subsequent use of tumor profiling. Barriers to patient participation included length of wait time for results and lack of a therapeutic option from the testing. Physicians who worked in AMCs reported a higher use of tumor profiling than did those who worked in non-AMC settings (43% v 18%; P = .0009). Access to a molecular tumor board was perceived as valuable by 56%. The study identified a need for educational materials to guide both physicians and patients in the field of genomic profiling. CONCLUSION: Physicians who participate in NCI-MATCH perceive value to patient treatment that outweighs the additional effort required; survey results help identify barriers that may limit participation. The current findings have implications for the design of future genomic and other profiling studies.

Patient familiarity with, understanding of, and preferences for clinical trial endpoints and terminology.

BACKGROUND: Although there is increased attention to designing and explaining clinical trials in ways that are clinically meaningful for patients, there is limited information on patient preferences, understanding, and perceptions of this content. METHODS: Maximum difference scaling (MaxDiff) methodology was used to develop a survey for assessing patients' understanding of 19 clinical terms and perceived importance of 9 endpoint surrogate phrases used in clinical trials and consent forms. The survey was administered electronically to individuals with metastatic breast cancer affiliated with the Metastatic Breast Cancer Alliance. Analyses were performed using Bayesian P values with statistical software. RESULTS: Among 503 respondents, 77% had a college degree, 70% were diagnosed with metastatic disease ≥2 years before survey completion, and 77% had received ≥2 lines of systemic therapy. Less than 35% of respondents reported understanding "fairly well" the terms symptomatic progression, duration of disease control, time to treatment cessation, and endpoints. Income level and time since onset of metastatic disease correlated with comprehension. Patients who had received ≥6 lines of therapy perceived that time until serious side effects (P < .001) and time on therapy (P < .001) were more important compared with those who had received only 1 line of therapy. Positively phrased parameters were associated with increased perceived importance. CONCLUSIONS: Even among educated, heavily pretreated patients, many commonly used clinical research terms are poorly understood. Comprehension and the perceived importance of trial endpoints vary over the course of disease. These observations may inform the design, discussion, and reporting of clinical trials.

Discerning the clinical relevance of biomarkers in early stage breast cancer.

PURPOSE: Prior data suggest that breast cancer patients accept significant toxicity for small benefit. It is unclear whether personalized estimations of risk or benefit likelihood that could be provided by biomarkers alter treatment decisions in the curative setting. METHODS: A choice-based conjoint (CBC) survey was conducted in 417 HER2-negative breast cancer patients who received chemotherapy in the curative setting. The survey presented pairs of treatment choices derived from common taxane- and anthracycline-based regimens, varying in degree of benefit by risk of recurrence and in toxicity profile, including peripheral neuropathy (PN) and congestive heart failure (CHF). Hypothetical biomarkers shifting benefit and toxicity risk were modeled to determine whether this knowledge alters choice. Previously identified biomarkers were evaluated using this model. RESULTS: Based on CBC analysis, a non-anthracycline regimen was the most preferred. Patients with prior PN had a similar preference for a taxane regimen as those who were PN naïve, but more dramatically shifted preference away from taxanes when PN was described as severe/irreversible. When modeled after hypothetical biomarkers, as the likelihood of PN increased, the preference for taxane-containing regimens decreased; similarly, as the likelihood of CHF increased, the preference for anthracycline regimens decreased. When evaluating validated biomarkers for PN and CHF, this knowledge did alter regimen preference. CONCLUSIONS: Patients faced with multi-faceted decisions consider personal experience and perceived risk of recurrent disease. Biomarkers providing information on likelihood of toxicity risk do influence treatment choices, and patients may accept reduced benefit when faced with higher risk of toxicity in the curative setting.

Genome-Wide Association Studies for Taxane-Induced Peripheral Neuropathy in ECOG-5103 and ECOG-1199.

PURPOSE: Taxane-induced peripheral neuropathy (TIPN) is an important survivorship issue for many cancer patients. Currently, there are no clinically implemented biomarkers to predict which patients might be at increased risk for TIPN. We present a comprehensive approach to identification of genetic variants to predict TIPN. EXPERIMENTAL DESIGN: We performed a genome-wide association study (GWAS) in 3,431 patients from the phase III adjuvant breast cancer trial, ECOG-5103 to compare genotypes with TIPN. We performed candidate validation of top SNPs for TIPN in another phase III adjuvant breast cancer trial, ECOG-1199. RESULTS: When evaluating for grade 3-4 TIPN, 120 SNPs had a P value of <10(-4) from patients of European descent (EA) in ECOG-5103. Thirty candidate SNPs were subsequently tested in ECOG-1199 and SNP rs3125923 was found to be significantly associated with grade 3-4 TIPN (P = 1.7 × 10(-3); OR, 1.8). Race was also a major predictor of TIPN, with patients of African descent (AA) experiencing increased risk of grade 2-4 TIPN (HR, 2.1; P = 5.6 × 10(-16)) and grade 3-4 TIPN (HR, 2.6; P = 1.1 × 10(-11)) compared with others. An SNP in FCAMR, rs1856746, had a trend toward an association with grade 2-4 TIPN in AA patients from the GWAS in ECOG-5103 (OR, 5.5; P = 1.6 × 10(-7)). CONCLUSIONS: rs3125923 represents a validated SNP to predict grade 3-4 TIPN. Genetically determined AA race represents the most significant predictor of TIPN.

Pharmacy Informatics: Current and Future Roles for the Pharmacy Technician.

Objective: To provide a background on pharmacy informatics and the current role of the pharmacy technician, as well as to review the different technologies that pharmacy technicians utilize in routine practice and identify opportunities for pharmacy technicians to assist pharmacists in the practice of pharmacy informatics. Data Sources: Articles were identified through searches of MEDLINE/PubMed (1946-March 2015) with the following search terms: pharmacy informatics and technician, medical informatics and technician, and technician informaticists. Additionally, informatics resources from the American Society of Health-Systems Pharmacists were used. Study Selection and Data Extraction: Articles that discussed the pharmacy technician's and/or other pharmacy staff's role in medical or pharmacy informatics were considered for inclusion. Data Synthesis: Several roles for the pharmacy technician were identified and reviewed in the literature and subsequently categorized based on the following identified themes: pharmacy technician informaticists, health-system pharmacy technicians, and community pharmacy technicians. Conclusions: As the field of pharmacy informatics continues to grow, pharmacy technicians will continue to play an integral role at various levels of pharmacy practice.

Does Integrated Care Affect Healthcare Utilization in Multi-problem Refugees?

A history of trauma is common in refugee populations and appropriate treatment is frequently avoided. Using a convenience sample of 64 patients in a Somali primary care clinic, a culture and trauma specific intervention was developed to address retention into appropriate treatment. One goal of the intervention was to improve the rate of engagement in psychotherapy after a mental health referral and to test the effect of psychotherapy on health care utilization using a staged primary care clinical tool. Forty-eight percent of patients given a mental health referral engaged in psychotherapy. Patients engaging in psychotherapy had higher baseline utilization and over 12 months trended towards less emergency room use and more primary care. Our findings suggest that the intervention improved referral and retention in mental health therapy for East African refugee women.

Pharmacy technician-to-pharmacist ratios: a state-driven safety and quality decision.

OBJECTIVE: To discuss the policy of pharmacy technician-to-pharmacist ratios by comparing Florida as an example of legislative-led authority versus Tennessee as an example of board of pharmacy-led ruling. SUMMARY: Over the past 2 years, the Florida legislature has debated the issue of pharmacy staffing ratios, initially leaving the Florida Board of Pharmacy with little authority to advocate for and enact safe technician staffing ratios. Anticipating this situation, the Tennessee Board of Pharmacy created rules to meet pharmacy staffing needs while protecting the authority of the pharmacist-in-charge and promoting patient safety. Before enacting rules, members of the board toured the state and talked about proposed rule changes with pharmacists. The final rule sets the pharmacy technician-to-pharmacist ratio at 2:1 but permits a 4:1 ratio based on public safety considerations and availability of at least two Certified Pharmacy Technicians. CONCLUSION: Pharmacists and leaders within the profession should conduct further research on appropriate and safe ratios of pharmacy technicians to pharmacists, with a focus on safety and quality of care.

Examining and predicting drug preferences of patients with metastatic breast cancer: using conjoint analysis to examine attributes of paclitaxel and capecitabine.

The purpose of the study was to examine variables that influence patients' decisions to undergo treatment for metastatic breast cancer as part of a larger effort to understand the utility of biomarkers in treatment decisions. An online survey containing treatment scenarios for a conjoint analysis was e-mailed to members of breast cancer support organizations. The survey contained 14 different scenarios in which survey respondents with a history of metastatic breast cancer were asked to choose between two treatments and whether or not they would undergo the treatment. The scenarios were designed based on paclitaxel and capecitabine profiles related to medication format, likelihood of benefit, and side effects. The likelihood of benefit and likelihood/severity of side effects associated with these two drugs were varied based on the range of predictability afforded by current biomarkers. Most of the 641 respondents indicated that they would opt to undergo a treatment with 27 or 33 % likelihood of benefit regardless of the toxicity scenario presented. In general, a high percentage of respondents indicated that they would choose treatment in all of the scenarios (e.g., for an intravenous medication with a 20-50 % likelihood of benefit and a 20-60 % likelihood of moderate peripheral neuropathy for 1 year, 65-94 % of respondents indicated that they would choose treatment). The conclusion is that this study found that likelihood of benefit was more important than toxicity when considering particular benefit and toxicity ranges associated with common treatment options for metastatic breast cancer.

Cervical cancer screening: exploring Appalachian patients' barriers to follow-up care.

This article describes a community-based Patient Navigation (PN) project conducted to identify potential barriers to seeking follow-up cervical cancer care in southeastern Kentucky. Patient navigators (PNs) were placed in cervical cancer programs within county public health departments where they interviewed patients about their perceived barriers to seeking follow-up care after receiving a positive Pap test result. Participants identified various potential barriers at three levels: the individual/personal level, the health care system level and the community/environmental level. One identified barrier that was unique to this study was a lack of consistency between follow-up recommendations and follow-up guidelines for patients under age 21. Implications are discussed.

Effectiveness of an Intervention for Adherence to Follow-up Recommendations for Abnormal Pap Tests in Appalachian Kentucky.

OBJECTIVE: In collaboration with rural county health departments (CHDs), we developed a patient navigation intervention to increase adherence to follow-up recommendations for women with abnormal Pap tests. METHODS: Local women were recruited, trained and placed in CHDs. Navigation was tailored to the follow-up care recommended. Effectiveness was evaluated in a quasi-experimental trial that included 13 intervention CHDs and 13 comparison group CHDs. Participants were enrolled from September 2008 through July 2010. RESULTS: A total of 478 participants were enrolled. The proportion that received recommended follow-up care was greater in the intervention CHDs (91.6%) than in the comparison group CHDs (80.8%) (p = .01). CONCLUSIONS: These results suggest that development of policy to promote navigation with rural health care delivery systems has great potential to improve patient outcomes.

Inconsistencies between medical records and patient-reported recommendations for follow-up after abnormal Pap tests.

PURPOSE: Adherence with recommended follow-up after an abnormal Pap test is a critical step in the prevention of cervical cancer. Here, we focused on identifying inconsistencies between self-reported and health department record recommendations for follow-up. METHODS: Self-reported recommendations for follow-up were collected by questionnaire from 519 women with abnormal Pap tests in rural Appalachia as part of a trial of the efficacy of patient navigation. Health department medical records were reviewed to collect healthcare provider recommendations. Measures of inconsistency (discordance) were calculated for overall recommendations and each of three particular follow-up recommendations: repeat Pap test, referral for further tests, and other gynecologist referral. RESULTS: The inconsistencies between the recommendation from the health department records and self-reports ranged from 15.0% (repeat Pap test) to 35.3% (gynecologist referral). Inconsistencies were most common among women with a history of abnormal Pap tests and those with more severe initial results. Recommendations for repeat Pap tests were correctly reported most often when the women recalled receiving a letter stating the results. Of greatest concern were the inconsistencies regarding recommendations for referral to a gynecologist. The more severe the Pap test result, the greater the odds of inaccurate self-reports of receiving a referral to a gynecologist for follow-up, p<0.001. CONCLUSIONS: Clinicians should be aware that patients with a history of abnormal results and severe Pap test abnormalities are at risk of misreporting recommendations for follow up.

Evaluation of Patient Needs and Patient Navigator Communication about Cervical Cancer Prevention in Appalachian Kentucky.

Few studies describe the way patient navigation processes may address disparities in treatment and follow-up care for medically underserved populations. Using a social ecological framework, we analyzed survey assessments of 519 patients completing a randomized navigation trial in Appalachia Kentucky to examine patient-reported barriers to follow-up cervical cancer care. We also analyzed in-depth interview transcripts with four lay patient navigators in the trial to identify barriers to follow-up care and to learn what communication strategies navigators use to successfully (or unsuccessfully) help patients navigate around those barriers. Our analysis provides insight into how patient navigation may improve adherence to follow-up care through assisted uncertainty management. We also discuss opportunities for improving navigator training to address disparities in clinical outcomes.

Safety and effectiveness outcomes of an inpatient collaborative drug therapy management service for direct thrombin inhibitors.

PURPOSE: The impact of a collaborative drug therapy management (CDTM) agreement enabling pharmacist-managed direct thrombin inhibitor (DTI) therapy was evaluated. METHODS: A retrospective chart review was conducted to compare selected outcome measures between cohorts of adults who received argatroban or bivalirudin therapy for suspected heparin-induced thrombocytopenia (HIT) before (n = 25) and after (n = 25) the implementation of an institutional DTI protocol under which properly trained and credentialed pharmacists have a primary role in dosing and monitoring DTI infusions. The primary endpoints were the mean time to attainment of activated partial thromboplastin time (aPTT) values in a specified therapeutic range and the proportion of total inpatient treatment time during which aPTT values were in that range. Secondary endpoints included the incidence of major and minor bleeding and the incidence of medication errors. RESULTS: After implementation of the DTI protocol, therapeutic aPTT values were achieved more rapidly (a mean of 3.4 hours in the postimplementation cohort versus a mean of 7.7 hours in the preimplementation cohort, p = 0.009) and maintained more consistently. Rates of bleeding and overall mortality were similar in the two groups; the frequencies of documented medication errors were 12% and 40% in the postimplementation and preimplementation cohorts, respectively (p = 0.05). CONCLUSION: A pharmacist-driven DTI program resulted in improved effectiveness and safety outcomes, as demonstrated by improved attainment of target aPTT values and a decreased frequency of medication errors.

Seeking health advice from social networks in low-income urban neighborhoods.

OBJECTIVES: To examine how individuals residing in low-income neighborhoods use their social networks for health advice. METHODS: Secondary data analysis of 363 individuals living in low-income neighborhoods was conducted using social network analysis and logistic regression techniques. RESULTS: Findings suggest that residents typically seek health advice from one or 2 friends and family members rather than a health professional. Age and family history of illness increased the likelihood that one would seek support whereas the combination of anxiety and depression decreased advice seeking. CONCLUSIONS: Findings support the need for multidisciplinary strategies for disseminating health information through informal social networks.

Epidemiological measures of childhood asthma: cross-sectional and longitudinal consistency.

BACKGROUND: Defining childhood asthma varies considerably, and the extent of agreement between various measures is not clearly understood in the absence of a recognized 'gold standard'. We compared different definitions of childhood asthma, identified characteristics that might have influenced their accuracy and an acquisition of an 'asthma' label in wheezy and treated children. METHODS: Using a prospective, population-based birth cohort of 623 children followed up to the age of 14 years the concordance between parental opinion, doctor's diagnosis reported by the parent and asthma's diagnosis in general practice (GP) was analysed using latent class analysis (LCA). RESULTS: At the age of eight, 'ever asthma' prevalences ranged from 15.5% (parental opinion) to 21.5% (GP record). 35% of children by the age of eight years had at least one reported label of asthma, reflecting both cross sectional and longitudinal inconsistencies. By the age of 14 years, 16% of children were inconsistently defined as 'ever asthmatic' by their parents. The prevalence of 'ever asthma' estimated by LCA was 19.3%, indicating a parental report of a doctor's diagnosis to be the most sensitive and specific definition. The likelihood of being labelled with asthma was higher in those with a parental or sibling history of asthma, but not determined by socio-demographic characteristics. CONCLUSIONS: Although the estimates of prevalence were similar for parental reports and GP records, agreement between the three sources was less than expected. Parental report of a doctor's diagnosis of asthma is sensitive, specific, longitudinally consistent and not subject to large socio-economic bias.

Engaging partners to initiate evaluation efforts: tactics used and lessons learned from the prevention research centers program.

BACKGROUND: The Centers for Disease Control and Prevention's (CDC's) Prevention Research Centers (PRC) Program underwent a 2-year evaluation planning project using a participatory process that allowed perspectives from the national community of PRC partners to be expressed and reflected in a national logic model. CONTEXT: The PRC Program recognized the challenge in developing a feasible, useable, and relevant evaluation process for a large, diverse program. To address the challenge, participatory and utilization-focused evaluation models were used. METHODS: Four tactics guided the evaluation planning process: 1) assessing stakeholders' communication needs and existing communication mechanisms and infrastructure; 2) using existing mechanisms and establishing others as needed to inform, educate, and request feedback; 3) listening to and using feedback received; and 4) obtaining adequate resources and building flexibility into the project plan to support multifaceted mechanisms for data collection. CONSEQUENCES: Participatory methods resulted in buy-in from stakeholders and the development of a national logic model. Benefits included CDC's use of the logic model for program planning and development of a national evaluation protocol and increased expectations among PRC partners for involvement. Challenges included the time, effort, and investment of program resources required for the participatory approach and the identification of whom to engage and when to engage them for feedback on project decisions. INTERPRETATION: By using a participatory and utilization-focused model, program partners positively influenced how CDC developed an evaluation plan. The tactics we used can guide the involvement of program stakeholders and help with decisions on appropriate methods and approaches for engaging partners.