Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop.

The US Food and Drug Administration and the Critical Path Institute's Patient-Reported Outcome (PRO) Consortium convened a cosponsored workshop on the use of PRO measures to inform the assessment of safety and tolerability in cancer clinical trials. A broad array of international stakeholders involved in oncology drug development and PRO measurement science provided perspectives on the role of PRO measures to provide complementary clinical data on the symptomatic side effects of anticancer agents. Speakers and panelists explored the utility of information derived from existing and emerging PRO measures, focusing on the PRO version of the National Cancer Institute's Common Terminology Criteria for Adverse Events. Panelists and speakers discussed potential ways to improve the collection, analysis, and presentation of PRO data describing symptomatic adverse events to support drug development and better inform regulatory and treatment decisions. Workshop participants concluded the day with a discussion of possible approaches to the patient-reported assessment of an investigational drug's overall side effect burden as a potential clinical trial end point. The Food and Drug Administration reiterated its commitment to collaborate with international drug development stakeholders to identify rigorous methods to incorporate the patient perspective into the development of cancer therapeutics.

Substance use disorder risk assessment: positive emotional experiences with first time use and substance use disorder risk.

Introduction: Substance Use Disorder (SUD) screening tools used in current practice are designed to identify SUD once patients have begun regular dangerous drug use. While these screening tools are valuable, prevention and avoidance of SUD would save countless lives. The climbing number of deaths due to drug overdose make screening for and prevention of SUD imperative. This study addresses this care gap. The aim was to develop a simple screening tool for patients who may be prone to develop Alcohol Use Disorder (AUD) and/or SUD prior to addiction. It was hypothesized that participants with initially positive emotional experiences would be correlated with a future SUD diagnosis. Methods: The study involved a self-administered survey using a cross-sectional design and was carried out over one-month in the spring of 2021. Those patients who presented to the MAT clinic (SUD group) were seen in a separate area than the patients presenting for urgent care (Comparison group). Participants (N = 259) were voluntarily recruited from MAT and Urgent care: Patients receiving acute care were assigned to the Comparison (N = 126, 50.8% female, 5.7% non-white, 27.2% age < 34) and those receiving treatment for SUD were assigned to the MAT group (N =133, 40.8% female, 4.8% non-white, 36.8% ≤34). The survey questioned demographics (4 items), risk factors for AUD/SUD (6 items), information about first alcohol/opioid experiences (16 items), and factors for seeking AUD/SUD treatment and recovery (2 items). Feelings were categorized as positive (e.g., euphoria, happiness, self-confident), neutral (e.g., nothing, normal), or negative (e.g., depressed, sad, sick). Results: The MAT group felt more positive feelings with first usage of alcohol and opioids compared to the comparison group (p<.001). With first usage of opioids specifically, MAT (0.13 ± 0.04) and comparison (0.29 ± 0.07) groups differed (p <.001). Over half (55.3%), of the MAT participants reported feeling self-confident with first use of alcohol while only 29.7% of the comparison reported this (p<.001). Over three-fifths (63.7%) of the MAT group reported feeling of euphoria with the first usage of opioids compared to one-tenth (9.8%) in the comparison group (p<.001). Discussion: This retrospective cross-sectional report shows the first affective responses to substances may predict risk for future SUD and could be a prevention screening tool. Asking patients about positive feelings with first usage of alcohol/opioids could be a simple screening tool employed for prevention.

Development and evaluation of a regional, large-scale interprofessional collaborative care summit.

The Northeastern/Central Pennsylvania Interprofessional Education Coalition (NECPA IPEC) is a coalition of faculty from multiple smaller academic institutions with a mission to promote interprofessional education. An interprofessional learning program was organized, which involved 676 learners from 10 different institutions representing 16 unique professions, and took place at seven different institutions simultaneously. The program was a 3-hour long summit which focused on the management of a patient with ischemic stroke. A questionnaire consisting of the Interprofessional Education Perception Scale (IEPS) questionnaire (pre-post summit), Likert-type questions, and open comment questions explored the learners' perceptions of the session and their attitudes toward interprofessional learning. Responses were analyzed using descriptive statistics and statistical tests for difference and qualitative thematic coding. The attitude of learners toward interprofessional education (as measured by the IEPS) was quite high even prior to the summit, so there were no significant changes after the summit. However, a high percentage of learners and facilitators agreed that the summit met its objective and was effective. In addition, the thematic analysis of the open-ended questions confirmed that students learned from the experience with a sense of the core competencies of interprofessional education and practice. A collaborative approach to delivering interprofessional learning is time and work intensive but beneficial to learners.

Physician assistant students' perceptions of an entry-level doctorate degree.

PURPOSE: In recent years, a growing trend toward clinical doctorate degrees has emerged in several allied health professions. However, few studies have been conducted within the physician assistant (PA) profession related to changing the entry-level degree for PAs to a clinical doctorate. METHODS: A descriptive, quantitative study assessing PA students' perceptions of changing the entry-level credential for PAs to a clinical doctorate was conducted. Thirty randomly selected programs with 1,966 students were invited to participate in the survey. RESULTS: Of the programs invited, 25 (83%) participated, with 486 (25%) full-time students completing the survey. Of the respondents, 56.1% (272) were first-year students and 43.9% (213) were second-year students. Both groups had a negative perception of changing the entry-level degree for PAs to a clinical doctorate, indicating the doctorate will raise the cost of PA education and discourage some people from entering the profession (82.1%, n = 398); a doctorate for PAs will cause confusion for patients (71.3%, n = 346); and that there is no need for the profession-specific doctorate since the master's degree sufficiently prepares PAs to practice in today's health care setting (70.9%, n = 344). CONCLUSIONS: The present findings lend additional support to previous studies, endorsing the master's degree as the entry-level and terminal degrees.