Medical Oncologists' Knowledge and Perspectives on the Use of Biosimilars in the United States.

PURPOSE: Despite increasing availability of biosimilar cancer treatments, little is known about oncologists' knowledge and concerns regarding biosimilar use in the United States. We surveyed medical oncologists to examine their knowledge, attitudes, and experience with biosimilars. METHODS: Oncologists recruited via the ASCO Research Survey Pool completed a 29-question survey in 2020 designed with input from clinical and health care system experts and literature review. RESULTS: Of the 269 respondents, most treated patients with biosimilars (n = 236, 88%) and reported that biosimilars were required at their institution (n = 168, 63%). Approximately half (n = 140, 52%) of oncologists correctly responded that biosimilars were not the same as generic medicines. Commonly reported barriers to use of biosimilars included concerns regarding a perceived lack of relevant research (n = 85, 33% reporting quite a bit/very much), the potential for extrapolation (n = 83, 33%), and efficacy limitations (n = 77, 30%). More oncologists from university hospitals (n = 36, 22%) than from community/private hospitals (n = 28, 38%) or private practices (n = 13, 38%) were concerned about biosimilar efficacy. A high proportion of oncologists reported that information on safety (n = 259, 99%) and efficacy (n = 255, 99%) is important when considering whether to use biosimilars. Less than half reported that their institution provided education about biosimilars (n = 108, 40%). CONCLUSION: In this sample of medical oncologists, knowledge about basic features of biosimilars was limited and access to information about biosimilars was insufficient. The present study determined that educational programs on biosimilars for oncologists are needed and identified priorities for such efforts.

Addressing Medical and Social Needs to Reduce Unnecessary Health Care Utilization and Costs: A Qualitative Study.

This study explored the goals, and care delivery approaches, of 14 interventions to address patients' medical and social needs. In qualitative interviews with clinicians and researchers, several themes emerged. Participants frequently described their overall goal as meeting patients' diverse needs to prevent avoidable acute care utilization. Medical needs were addressed by ensuring patients received primary care and actively coordinating care across clinical settings. Participants perceived social needs as tightly linked with medical needs, as well as a need for interpersonal skills among intervention staff. Descriptions of overall approaches to meeting patients' needs frequently aligned with principles of trauma-informed care and patient-centered care.

Health provider perspectives of electronic medication monitoring in outpatient asthma care: a qualitative investigation using the consolidated framework for implementation research.

OBJECTIVE: Little is known about the implementation challenges health providers might face with the use of digital health in outpatient asthma care. To qualitatively explore the experience of health providers with electronic medication monitoring (EMM) using an implementation science framework. METHODS: Using the Consolidated Framework of Implementation Research (CFIR), we conducted interviews (n = 10) exploring health providers' experience with EMM with asthma patients from 5 primary care or specialty clinics. The EMM tracked albuterol and inhaled corticosteroid (ICS) use, and health providers called parents whenever ICS adherence waned, or albuterol use increased. Interviews were audio-recorded, transcribed, and deductively analyzed using directed content analysis. RESULTS: Health providers reported the intervention's primary advantage, compared with current asthma care, was the ability to monitor medication use at-home. Most felt the intervention improved care delivery. Nurses and medical assistants described a process of phone calls and checking alerts, that had varying levels of administrative burden and complexity. Health providers felt that sustained implementation of the intervention model would require additional employees to handle the administrative and clinical workload. Half of the interviewed providers were unsure if patient needs were met by the intervention, while some cited technology syncing issues, others liked the enhanced interactions for asthma education. CONCLUSION: Health providers reported positive experiences supporting parents and children with asthma using EMM but also highlighted intervention components that needed improvement or refinement to yield successful implementation in outpatient pediatric clinics. Recommendations for enhancing the intervention for a scaled-up implementation were discussed.

Optimizing brief, focused assessment of priority symptoms and concerns in recurrent and/or metastatic squamous cell carcinoma of the head and neck: Content validation of the Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network Head and Neck Symptom Index-10 (FHNSI-10).

BACKGROUND AND AIMS: Patients with recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) experience vast disease and treatment burdens. Brief, focused instruments are needed to assess patient-reported priority symptoms and concerns as targeted outcome assessments for use in clinical research. Although the instrument was developed based on expert and patient input and is psychometrically valid, the Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Head and Neck Symptom Index-10 (FHNSI-10) has yet to undergo content validation from the perspective of R/M SCCHN patients to evaluate its use as a brief symptom-focused targeted endpoint assessment for use in clinical research. METHODS: Interviews conducted with R/M SCCHN patients explored priority symptoms and concerns, followed by cognitive debriefing of the FHNSI-10 to evaluate face validity. Transcripts were analyzed, and results were mapped to the FHNSI-10. In accordance with published recommendations, expert input from the original development and published literature was considered for content validity assessment. RESULTS: A total of 18 patients participated in a concept elicitation interview; saturation was obtained at interview 17. Most (83%) were undergoing active treatment, male (94%), white (72%), and did not have a college degree (67%). The most commonly mentioned symptoms were lumps/swelling, pain, sore throat, difficulty swallowing, and voice changes. For all items, ≥75% reported each question was relevant to their R/M SCCHN experience and 94% reported the instrument captured their experiences with R/M SCCHN. CONCLUSION: Results provide support for the content validity of the FHNSI-10, inasmuch as all 10 items were spontaneously reported and considered relevant to R/M SCCHN. Content validity might be enhanced by adding cough and hearing impairment items; however, the existing FHNSI-10 covers the majority of symptoms uncovered in interviews with a small sample of R/M SCCHN patients.

Development of the Functional Assessment of Cancer Therapy-Carcinoid Syndrome Symptom Index.

OBJECTIVE: To develop a symptom-focused index to evaluate representative symptoms, treatment side effects, and emotional and functional well-being of patients with carcinoid syndrome (CS). METHODS: The development of the Functional Assessment of Cancer Therapy-Carcinoid Syndrome Symptom Index (FACT-CSI) followed US Food and Drug Administration guidelines for the development of patient-reported outcome (PRO) measures and involved the following: (a) literature review; (b) interviews with 14 CS patients; (c) interviews with 9 clinicians; and (d) instrument development involving input from a range of PRO measure development and CS experts. The resulting draft instrument underwent cognitive interviews with 7 CS patients. RESULTS: Forty-six CS sources were reviewed. Analysis of patient interviews produced 23 patient-reported symptoms. The most frequently endorsed physical symptoms were flushing, diarrhea, abdominal pain, fatigue, and food sensitivity/triggers. Seven priority CS emotional and functional themes were also identified by patients. Expert interviews revealed 12 unique priority symptoms - the most common being diarrhea, flushing, wheezing, edema, abdominal pain/cramping, fatigue, and 8 emotional and functional concerns. Through an iterative process of team and clinical collaborator meetings, data review, item reduction and measure revision, 24 items were selected for the draft symptom index representing symptoms, emotional concerns, global assessment of treatment side effects, and functional well-being. Cognitive interview results demonstrated strong content validity, including positive endorsement of item clarity (>86% across items), symptom relevance (>70% for most items), and overall measure content (86%). CONCLUSIONS: The FACT-CSI is a content-relevant, symptom-focused index reflecting the highest priority and clinically relevant symptoms and concerns of people with CS.

Neuropathy experienced by colorectal cancer patients receiving oxaliplatin: A qualitative study to validate the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale.

BACKGROUND: Although oxaliplatin is widely established as a standard treatment in colorectal cancer (CRC), oxaliplatin-induced neuropathy has emerged as a prominent dose-limiting side effect associated with quality of life decrements. Ongoing monitoring and management of neuropathy is important for CRC patient quality of life and adherence to treatment. Therefore, a validated self-reported measure of neuropathy would aid in the management and assessment of oxaliplatin-induced neuropathy in clinical practice and research. We sought to evaluate the content validity of the 13-item Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity subscale (FACT/GOG-Ntx) for CRC patients receiving oxaliplatin. AIM: To understand the neuropathy experiences of CRC patients and assess content validity of the FACT/GOG-Ntx. METHODS: Semi-structured concept elicitation and cognitive debriefing interviews were conducted with 31 CRC patients experiencing peripheral neuropathy from current or previous oxaliplatin treatment. Interview data were analyzed using a constant comparative approach, and data were mapped to the FACT/GOG-Ntx to assess content validity. RESULTS: Mean age of the sample was 54 (range 34-82). The sample was primarily Caucasian (84%) and consisted of nearly equal numbers of men and women. Participants described 28 unique neuropathy symptoms; hand tingling (experienced by 87% of respondents); feet tingling (81%); hand numbness (68%); and feet numbness (84%) were most frequently mentioned. Neuropathy symptoms occurring on the feet were most often identified as most bothersome by participants. Eleven of the 13 FACT/GOG-Ntx items exhibited moderate to strong evidence of content validity. Two items related to trouble hearing and ringing in the ears had weak support; however, these items represent severe neuropathy and could be useful for a patient reported outcome measure. CONCLUSION: The FACT/GOG-Ntx represents the key neuropathy experiences of CRC patients treated with oxaliplatin.

Patients believe that cosmetic procedures affect their quality of life: An interview study of patient-reported motivations.

BACKGROUND: Although treatments to address cosmetic concerns are common, patients' self-reported motives for considering such procedures have not been systematically explored. OBJECTIVE: To develop a framework of categories to describe patients' self-reported motivations for undergoing minimally invasive cosmetic procedures. METHODS: Face-to-face, semistructured patient interviews were conducted with adult participants who had undergone or were considering minimally invasive cosmetic dermatologic procedures. A qualitative constant comparative approach was used to analyze interview transcripts, yielding themes and subthemes. RESULTS: A total of 30 interviews were completed. Most patient-reported motivations for cosmetic procedures could be subsumed under 8 general categories (themes): (1) mental and emotional health, (2) cosmetic appearance, (3) physical health, (4) work and/or school success, (5) social well-being, (6) cost and/or convenience, (7) procedural perceptions, and (8) timing of treatment. Many individual motivations in these categories were unrelated to desire for physical beauty. In particular, participants wanted to avoid being self-conscious, enhance confidence, reduce the time and expense required to conceal physical imperfections, and be perceived as capable at work. LIMITATIONS: Only English-speaking patients in the United States were interviewed. CONCLUSION: Patient-reported motivations for cosmetic procedures mostly pertained to physical and psychosocial well-being. Indeed, a desire for improved cosmetic appearance was only 1 of the 8 themes revealed through the patient interviews.

A Comprehensive Conceptual Model of the Experience of Chronic Itch in Adults.

BACKGROUND: Itch is common and often debilitating. Itch is best assessed by self-report, often using patient-reported outcome measures (PROMs). Current PROMs for itch are limited and may not capture its full impact on quality of life (QOL). OBJECTIVE: We sought to develop a comprehensive conceptual model of itch to improve the understanding of itch for clinicians and to serve as a framework for development of efficient and valid PROMs of itch. METHODS: Using mixed methods, including systematic review (n = 491 articles), semi-structured interviews (n = 33 adults with chronic itch with multiple etiologies), and grounded theory using a constant comparative approach, we developed a conceptual model of itch. RESULTS: We found the Wilson and Cleary model to be a reasonable framework for organizing our findings. It includes five primary components: biological and physiological variables, symptom status, functional status, general health perceptions, and QOL. We propose a causal relationship beginning with the biological and physiological driving factors, with direct and indirect impacts of itch and its sequelae, including pain and sleep disturbance. These can impair function, lead to task avoidance, stigma, social life and relationship problems, emotional disturbances, and treatment burden. Together, these sequelae alter one's perceptions of health, QOL, and treatment response. CONCLUSIONS: Our conceptual model demonstrates the profound patient-burden of itch and identifies unmet needs in the evaluation and management of itch.

Conveying empathy to hospice family caregivers: team responses to caregiver empathic communication.

OBJECTIVE: The goal of this study was to explore empathic communication opportunities presented by family caregivers and responses from interdisciplinary hospice team members. METHODS: Empathic opportunities and hospice team responses were analyzed from bi-weekly web-based videoconferences between family caregivers and hospice teams. The authors coded the data using the Empathic Communication Coding System (ECCS) and identified themes within and among the coded data. RESULTS: Data analysis identified 270 empathic opportunity-team response sequences. Caregivers expressed statements of emotion and decline most frequently. Two-thirds of the hospice team responses were implicit acknowledgements of caregiver statements and only one-third of the team responses were explicit recognitions of caregiver empathic opportunities. CONCLUSION: Although hospice team members frequently express emotional concerns with family caregivers during one-on-one visits, there is a need for more empathic communication during team meetings that involve caregivers. PRACTICE IMPLICATIONS: Hospice clinicians should devote more time to discussing emotional issues with patients and their families to enhance patient-centered hospice care. Further consideration should be given to training clinicians to empathize with patients and family caregivers.