Health Policy Commons^™

Antitumor Efficacy And Safety Of Unedited Autologous Cd5car T Cells In Relapsed/Refractory Mature T-Cell Lymphomas, Laquisa C Hill, Rayne H Rouce, Mengfen J Wu, Tao Wang, Royce Ma, Huimin Zhang, Birju Mehta, Natalia Lapteva, Zhuyong Mei, Tyler S Smith, Lina Yang, Madhuwanti Srinivasan, Phillip M Burkhardt, Carlos A Ramos, Premal Lulla, Martha Arredondo, Bambi Grilley, Helen E Heslop, Malcolm K Brenner, Maksim Mamonkin

Center for Medical Ethics and Health Policy Staff Publications

Despite newer targeted therapies, patients with primary refractory or relapsed (r/r) T-cell lymphoma have a poor prognosis. The development of chimeric antigen receptor (CAR) T-cell platforms to treat T-cell malignancies often requires additional gene modifications to overcome fratricide because of shared T-cell antigens on normal and malignant T cells. We developed a CD5-directed CAR that produces minimal fratricide by downmodulating CD5 protein levels in transduced T cells while retaining strong cytotoxicity against CD5⁺ malignant cells. In our first-in-human phase 1 study (NCT0308190), second-generation autologous CD5.CAR T cells were manufactured from patients with r/r T-cell malignancies. Here, we report safety …

Investigating The Roles And Responsibilities Of Institutional Signing Officials After Data Sharing Policy Reform For Federally Funded Research In The United States: National Survey, Jinyoung Baek, Jonathan Lawson, Vasiliki Rahimzadeh

Center for Medical Ethics and Health Policy Staff Publications

Background: New federal policies along with rapid growth in data generation, storage, and analysis tools are together driving scientific data sharing in the United States. At the same, triangulating human research data from diverse sources can also create situations where data are used for future research in ways that individuals and communities may consider objectionable. Institutional gatekeepers, namely, signing officials (SOs), are therefore at the helm of compliant management and sharing of human data for research. Of those with data governance responsibilities, SOs most often serve as signatories for investigators who deposit, access, and share research data between institutions. Although …

Waiving Snap Interviews During The Covid-19 Pandemic Increased Snap Caseloads, Colleen Heflin, William Fannin, Leonard M. Lopoo, Siobhan O'Keefe

Population Health Research Brief Series

Food insecurity in the United States reached historically high rates during the COVID-19 pandemic, thus substantially increasing demand for the Supplemental Nutrition Assistance Program (SNAP). To facilitate access to SNAP during the pandemic, the federal government granted state SNAP offices the option to waive the interview requirement – an administrative burden associated with the SNAP certification process. This brief summarizes findings from a recent study that used data from SNAP offices across 10 states to examine the impact of SNAP interview waivers on SNAP caseloads from January 5th to April 30th of 2021. Findings reveal that counties that implemented the …

Urban-Rural Differences In School Districts' Local Wellness Policies And Policy Implementation Environments, Swati Iyer, Timothy J Walker, Alexandra L Macmillan Uribe, Chad D Rethorst, Rebecca A Seguin-Fowler, Jacob Szeszulski

Faculty, Staff and Student Publications

Higher rates of obesity in rural compared to urban districts suggest environmental differences that affect student health. This study examined urban-rural differences in districts' local wellness policies (LWPs) and LWP implementation environments. Cross-sectional data from two assessments in Texas were analyzed. In assessment one, each district's LWP was reviewed to see if 16 goals were included. In assessment two, an audit was conducted to identify the presence of a wellness plan (a document with recommendations for implementing LWPs), triennial LWP assessment, and school health advisory councils (SHACs) on the district website. Rural districts' LWPs had a smaller number of total …

A Systematic Review Of Naldemedine And Naloxegol For The Treatment Of Opioid-Induced Constipation In Cancer Patients, Ursula K Braun, Leanne K Jackson, Mary A Garcia, Syed N Imam

Center for Medical Ethics and Health Policy Staff Publications

Background: Opioid-induced constipation (OIC) is a pervasive and distressing side effect of chronic opioid therapy in patients with cancer pain, significantly impacting their quality of life. Peripherally acting μ-opioid receptor antagonists (PAMORAS) were developed for treatment-resistant OIC but most studies were conducted with non-cancer patients.

Objective: to discuss two oral formulations of PAMORAs, naldemedine and naloxegol, and to review available evidence of the effectiveness of these drugs for OIC in cancer patients.

Methods: a comprehensive search to identify primary literature for either naldemedine or naloxegol for OIC in cancer patients.

Results: Only three prospective randomized, double-blind, placebo-controlled clinical trials for …

Environmental Detection Of Parasites In The Marginalized Paiute Reservations Compared To A Nearby Area, Shannon Mckim, Kristen Kopystynsky, Nathaniel Wolf, Fahim A Akbar, Maria Elena Bottazzi, Peter J Hotez, Rojelio Mejia

Center for Medical Ethics and Health Policy Staff Publications

The amounts of parasite DNA in soil samples from different playgrounds and other public areas can help identify areas of possible microbe transmission and give indications of the possible occurrence of parasite infection in nearby communities. We collected 207 soil samples from parks in Paiute indigenous tribal areas in southwestern Utah and from the higher income city of St. George, Utah, and tested them for 11 parasites that can cause human disease. Molecular tests revealed an elevated odds ratio (OR) of 3.072 (range, 1.114-8.065) for detecting the helminth Trichuris trichiura and an elevated OR of 3.036 (range, 1.101-7.966) for any …

Rational Prescribing Of Pancreatic Enzymes For Patients With Pancreatic Cancer, Mary Acelle G Garcia, Syed Imam, Ursula K Braun, Leanne K Jackson

Center for Medical Ethics and Health Policy Staff Publications

Most patients with pancreatic cancer at some point present with symptoms related to exocrine pancreatic insufficiency (EPI). These include diarrhea, abdominal bloating, indigestion, steatorrhea, weight loss, and anorexia. Even though up to 80% of pancreatic cancer patients eventually present with symptoms related to exocrine pancreatic insufficiency, only 21% are prescribed pancreatic enzyme replacement therapy (PERT). Its effectiveness is also highly dependent on its proper timing of administration, and patients must be thoroughly educated about this. The impact of symptoms of EPI can lead to poorer overall well-being. Pharmacists play a crucial role in properly educating patients on the correct use …

Pornography: Social, Emotional And Mental Implications Among Adolescents, William K. Canady

National Youth Advocacy & Resilience Conference

This presentation will explain the historical development of pornography. It will highlight three segments: 1- Porn’s impact on brain development of reward pathways, ultimately increasing the appetite for more porn. 2- Porn can be a false substitute for real intimacy, resulting in decreased sexual satisfaction with a real person and increased verbal and physical aggression. 3- Porn promotes sex trafficking, promotes multiple sex partners and reduced STD prevention.

Western Maine Addiction And Recovery Initiative's Substance Misuse Prevention And Wellness Day: Year 2 Planning Survey Summary For Ohchs, Evelyn Ali Bs, Tyler Egeland Ba, Mary Lindsey Smith Phd

Substance Use Research & Evaluation

The RCORP local evaluation team at the Catherine Cutler Institute deployed a survey to Oxford Hills Comprehensive High School (OHCHS). The purpose of the survey was to understand needs unique to OHCHS to plan for types of activities and information presented at the school’s Substance Use Prevention and Wellness Day. For more information, please contact Lindsey Smith at [email protected]

Identifying Rural Health Clinics Within The Transformed Medicaid Statistical Information System (T-Msis) Analytic Files, Katherine Ahrens Mph, Phd, Zachariah Croll, Yvonne Jonk Phd, John Gale Ms, Heidi O'Connor Ms

Rural Health Clinics

Researchers at the Maine Rural Health Research Center describe a methodology for identifying Rural Health Clinic encounters within the Medicaid claims data using Transformed Medicaid Statistical Information System (T-MSIS) Analytic Files.

Background: There is limited information on the extent to which Rural Health Clinics (RHC) provide pediatric and pregnancy-related services to individuals enrolled in state Medicaid/CHIP programs. In part this is because methods to identify RHC encounters within Medicaid claims data are outdated.

Methods: We used a 100% sample of the 2018 Medicaid Demographic and Eligibility and Other Services Transformed Medicaid Statistical Information System (T-MSIS) Analytic Files for 20 states …

Self-Sampling For Human Papillomavirus Testing: Acceptability In A Us Safety Net Health System, Susan L Parker, Trisha L Amboree, Shaun Bulsara, Maria Daheri, Matthew L Anderson, Susan G Hilsenbeck, Maria L Jibaja-Weiss, Mohammed Zare, Kathleen M Schmeler, Ashish A Deshmukh, Elizabeth Y Chiao, Michael E Scheurer, Jane R Montealegre

Center for Medical Ethics and Health Policy Staff Publications

Introduction: Self-sampling for human papillomavirus testing is increasingly recognized as a strategy to expand cervical cancer screening access and utilization. Acceptability is a key determinant of uptake. This study assesses the acceptability of and experiences with mailed self-sampling kits for human papillomavirus testing among underscreened patients in a safety net health system.

Methods: A nested telephone survey was administered between 2021 and 2023 to a sample (n=272) of the 2,268 participants enrolled in the Prospective Evaluation of Self-Testing to Increase Screening trial. Trial participants include patients of a safety net health system aged 30-65 years who were not up to …

Pretesting Discrete-Choice Experiments: A Guide For Researchers, Nicola B Campoamor, Christi J Guerrini, Whitney Bash Brooks, John F P Bridges, Norah L Crossnohere

Center for Medical Ethics and Health Policy Staff Publications

Discrete-choice experiments (DCEs) are a frequently used method to explore the preferences of patients and other decision-makers in health. Pretesting is an essential stage in the design of a high-quality choice experiment and involves engaging with representatives of the target population to improve the readability, presentation, and structure of the preference instrument. The goal of pretesting in DCEs is to improve the validity, reliability, and relevance of the survey, while decreasing sources of bias, burden, and error associated with preference elicitation, data collection, and interpretation of the data. Despite its value to inform DCE design, pretesting lacks documented good practices …

Governmental Affairs Update, Neema Katibai Jd

The Journal of the Michigan Dental Association

The article presents the American Dental Association's federal advocacy achievements during the first half of the 118th Congress. The ADA has made significant strides in influencing policy and regulations across various categories, including workforce issues, dental insurance reform, access to care, student loan debt, Medicaid, practice management, veterans' affairs, health information technology, and public health. Their efforts span from urging legislative action to collaborating with federal agencies and Congress members. These accomplishments showcase the ADA's commitment to advancing dental profession interests nationally.

Special Insert: Guideline For Delegation Of Duties For Allied Dental Personnel In Michigan, David Foe Ma

The Journal of the Michigan Dental Association

Dental assistants, registered dental assistants, and registered dental hygienists have specific duties they can perform for patients as outlined by the Michigan Public Health Code and the Michigan Board of Dentistry General Rules. Permitted delegated services vary based on a team member’s level of training, licensure, and available supervision by a licensed dentist.

The Journal of Michigan Dental Association provides this pullout insert to guide the dental team. This easy-to-read chart quickly identifies recent changes to the duties each dental auxiliary can legally perform.

Grievance Politics And Technocracy In A Developmental State, Ijlal Naqvi, Federico M. Rossi, Rayner Kay Jin Tan

Research Collection School of Social Sciences

This article uses a process-tracing approach to understand changes in Singapore’s health sector from the start of self-rule in 1959 to the end of the COVID-19 pandemic in 2022. Singapore is a developmental state recognized for its effective management of healthcare costs and its lack of political freedom. In both respects, the ‘Singapore model’ is of interest to other cities and nations. The standard narrative is one of technocratic proficiency in a context in which civic freedoms are heavily constrained, but this article identifies the surprisingly important role of social voices at key moments. It finds episodes in which effective …

Igg In The Trenches: Results Of An In-Depth Interview Study On The Practice, Politics, And Future Of Investigative Genetic Genealogy, Christi J Guerrini, Whitney Bash Brooks, Jill O Robinson, Stephanie M Fullerton, Emily Zoorob, Amy L Mcguire

Center for Medical Ethics and Health Policy Staff Publications

Investigative genetic genealogy (IGG) is a new technique for identifying criminal suspects and unidentified deceased and living persons that has sparked controversy. In a criminal case, the technique involves uploading genetic information left by a putative perpetrator at the crime scene to one or more direct-to-consumer genetic genealogy databases with the intention of identifying the perpetrator's genetic relatives and, eventually, locating the perpetrator on the family tree. In 2018, IGG helped to identify the Golden State Killer, and it has since been used in hundreds of investigations in the United States. Here, we report findings from in-depth interviews with 24 …

A Phase 1 Trial Utilizing A Pharmacokinetic Endpoint To Determine The Optimal Dose Of Ramucirumab In Children And Adolescents With Relapsed Or Refractory Solid Tumors, Including Central Nervous System Tumors, Kristy L Pilbeam, Kamnesh Pradhan, James Croop, Charles G Minard, Xiaowei Liu, Stephan D Voss, Emasenyie Isikwei, Stacey L Berg, Joel M Reid, Elizabeth Fox, Brenda J Weigel

Center for Medical Ethics and Health Policy Staff Publications

Background: Ramucirumab is a monoclonal antibody that binds the extracellular domain of vascular endothelial growth factor receptor (VEGFR-2) and prevents binding of VEGF ligands. Based on population pharmacokinetic (PK) analysis and correlation with efficacy in adults, a target steady state trough concentration (Css,min ) ≥ 50 µg/mL was established.

Procedures: This phase 1 trial (ADVL1416) used a rolling six design and a PK primary endpoint to define the recommended phase 2 dose (RP2D) of ramucirumab in children with recurrent/refractory solid tumors. Two dose levels (DL) were planned (DL1: 8 mg/kg, DL2: 12 mg/kg administered intravenously [IV] every 2 weeks). Toxicity …

Parental Descriptions Of Childhood Avoidance Symptoms After Trauma, Zoe Blair-Andrews, Alison Salloum, Stephanie Evans, Vicky Phares, Eric A Storch

Center for Medical Ethics and Health Policy Staff Publications

Recognizing and diagnosing the avoidance symptom cluster of posttraumatic stress disorder (PTSD) in young children has been challenging. This study examines caregivers' descriptions of young children's avoidance reactions. By describing parents' examples of childhood avoidance, clinicians, researchers, and educators may be able to provide more specific psychoeducation which may improve identification of avoidance behaviors in young children. Caregivers (N=73) of young children (age 3-7 years) participated in a semi-structured diagnostic clinical interview prior to enrolling in a clinical trial for childhood trauma. The assessment regarding the caregiver's description of the child's avoidance was audio recorded and transcribed for a thematic …

Case Sampling For Evaluating Hospital Postoperative Morbidity In Us Surgical Quality Improvement Programs, Vivi W Chen, Tracey Rosen, Yongquan Dong, Peter A Richardson, Jennifer R Kramer, Laura A Petersen, Nader N Massarweh

Center for Medical Ethics and Health Policy Staff Publications

Importance: US surgical quality improvement (QI) programs use data from a systematic sample of surgical cases, rather than universal review of all cases, to assess and compare risk-adjusted hospital postoperative complication rates. Given decreasing postoperative complication rates over time and the types of cases eligible for abstraction, it is unclear whether case sampling is robust for identifying hospitals with higher than expected complications.

Objective: To compare the assessment of hospital 30-day complication rates derived from sampling strategy used by some US surgical QI programs relative to universal review of all cases.

Design, setting, and participants: This US hospital-level analysis took …

Building Effective Mentoring Relationships During Clinical Ethics Fellowships: Pedagogy, Programs, And People, Trevor M Bibler, Ryan H Nelson, Bryanna Moore, Janet Malek, Mary A Majumder

Center for Medical Ethics and Health Policy Staff Publications

How should clinical ethicists be trained? Scholars have stated that clinical ethics fellowships create well-trained, competent ethicists. While this appears intuitive, few features of fellowship programs have been publicly discussed, let alone debated. In this paper, we examine how fellowships can foster effective mentoring relationships. These relationships provide the foundation for the fellow's transition from novice to competent professional. In this essay, we begin by discussing our pedagogical commitments. Next, we describe the structures our program has created to assist our fellows in becoming competent ethicists. We then outline the kinds of knowledge, skills, and professional attributes mentors should possess. …