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.

Professional societies can play a vital role in career development.

Ph.D.s in the life sciences are seeking nonacademic careers in large numbers, and private sector employment is reaching an all-time high. In this climate, trainees are seeking mentors and opportunities to understand and explore different career paths. Scientific societies such as the Society for Developmental Biology play vital roles in professional development to support members at all stages of their careers and promote a range of employment opportunities. To this end, the Professional Development and Education Committee of the society offers full day workshops and sessions at regional and annual meetings that support constituents throughout their careers. For example, a new GetHIRED! workshop the day before the 2019 annual society meeting was developed as an interactive job skills workshop for postdoctoral fellows to gain insights into the job application process. The committee also aims to advocate for innovative approaches to teaching and science literacy in both the classroom and through outreach activities. The activities offered by scientific societies can reach a broader audience than individual institutions, and have lasting impacts in the quality of their members' careers by augmenting professional development opportunities.

Addressing Costs and Continuity of Care through Innovative Solutions for Infused Therapies: A Collaborative Experience with Infliximab.

BACKGROUND: Infused therapies are becoming more common as pharmaceutical and biotechnology companies increasingly focus their research and development efforts on biologic agents. OBJECTIVE: To understand how collaborative efforts among a health plan, providers, and specialty pharmacies can improve the efficiency of delivering infused therapies, using the example of a pilot program in southern Ohio for the administration of infliximab. METHODS: In October 2008, the authors conducted one-on-one, in-person interviews with representatives of a health plan, a specialty pharmacy, and the 3 largest gastroenterology practices in a southern Ohio community that collaborated to develop an innovative pilot program for delivering infliximab for patients with inflammatory bowel disease in a cost-effective manner in the office setting. The 2 health plan and 1 specialty pharmacy representatives were directly involved with the development and implementation of the program. Gastroenterology practice representatives included 3 practice managers, 2 infusion nurses, 2 billing managers, and 1 precertification specialist. RESULTS: The interviews revealed the opportunities and challenges associated with managing infused therapies, as well as the potential unintended consequences of unilateral action by health plans. As a result of changes introduced by a local health plan in southern Ohio, 3 of the largest gastroenterology practices in the region decided to discontinue in-office infliximab infusions for their patients and send them to local hospital outpatient infusion centers. However, before the implementation of this policy, a new collaboration between the health plan, the 3 practices, and the health plan's specialty pharmacy enabled these practices to continue to provide this medication in their offices. This collaboration avoided cost increases to all involved by preventing the shift of patients to hospital outpatient departments and allowing patients to continue their care in the office setting. CONCLUSION: It will become increasingly important for payers to develop and support cost-effective ways to provide physicians and patients with access to infused medications. This pilot program shows the benefits of collaboration among healthcare stakeholders to identify innovative solutions for delivering appropriate office-based infusion therapy. The specific approach that is most appropriate for a specific health plan will depend on the unique local market circumstances.

Quality assessment of genetic markers used for therapy stratification.

PURPOSE: Therapy stratification based on genetic markers is becoming increasingly important, which makes commitment to the highest possible reliability of the involved markers mandatory. In neuroblastic tumors, amplification of the MYCN gene is an unequivocal marker that indicates aggressive tumor behavior and is consequently used for therapy stratification. To guarantee reliable and standardized quality of genetic features, a quality-assessment study was initiated by the European Neuroblastoma Quality Assessment (ENQUA; connected to International Society of Pediatric Oncology) Group. MATERIALS AND METHODS: One hundred thirty-seven coded specimens from 17 tumors were analyzed in 11 European national/regional reference laboratories using molecular techniques, in situ hybridization, and flow and image cytometry. Tumor samples with divergent results were re-evaluated. RESULTS: Three hundred fifty-two investigations were performed, which resulted in 23 divergent findings, 17 of which were judged as errors after re-evaluation. MYCN analyses determined by Southern blot and in situ hybridization led to 3.7% and 4% of errors, respectively. Tumor cell content was not indicated in 32% of the samples, and 11% of seemingly correct MYCN results were based on the investigation of normal cells (eg, Schwann cells). Thirty-eight investigations were considered nonassessable. CONCLUSION: This study demonstrated the importance of revealing the difficulties and limitations for each technique and problems in interpreting results, which are crucial for therapeutic decisions. Moreover, it led to the formulation of guidelines that are applicable to all kinds of tumors and that contain the standardization of techniques, including the exact determination of the tumor cell content. Finally, the group has developed a common terminology for molecular-genetic results.