From Passive Gatekeeper to Quarterback: Evolving Perceptions of Primary Care Among Medical Students in Longitudinal Outpatient Clerkships.

BACKGROUND: Longitudinal clerkships provide students with meaningful clinical care roles that promote learning and professional development. It remains unclear how longitudinal primary care clerkships inform students' perceptions of primary care. OBJECTIVE: To explore perceptions of primary care among medical students enrolled in longitudinal primary care clerkships. DESIGN: Qualitative, semi-structured interviews with medical students over 4 years. PARTICIPANTS: Thirty-eight medical students participated at baseline; 35 participated in a 2-year follow-up interview; 24 participated at 4 years. Each student was enrolled in one of two longitudinal primary care clerkships: a team-based Education-Centered Medical Home (ECMH) or a one-on-one individual preceptorship (IP). APPROACH: De-identified interview transcripts were analyzed using a process of open and axial coding, followed by elaborative coding for longitudinal analysis. Codes were compiled into a set of themes and compared across time periods and between clerkships. KEY RESULTS: Students reported that primary care serves as a first point of contact, emphasizing longitudinal care with a wide scope of practice and approaching patient care with a biopsychosocial perspective. Student perceptions of primary care greatly expanded over the course of 4 years: for instance, initial perceptions of primary care physicians evolved from "passive gatekeeper" to a more nuanced "quarterback." Students in ECMH, whose clerkship provided more opportunity for patient continuity, further reflected on the relationships they themselves developed with patients. CONCLUSIONS: Regardless of their eventual specialty choice, longitudinal experiences may aid all students in fostering a sense of the broad scope and importance of primary care. However, without numerous opportunities to witness continuity of care, students may perceive primary care as having limited scope and importance. Longitudinal clerkships, emphasizing continuity with patients and preceptors, may foster in students a broad and nuanced perspective of the scope of primary care as a field.

Do You Recall?: Results From a Within-Person Recall Study of the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function 8c.

OBJECTIVES: This study aimed to determine whether responses to Patient-Reported Outcomes Measurement Information System Short Form v2.0 - Physical Function 8c (PROMIS PF8c) items differed when the use of a 7-day recall period was compared with no specified recall period. METHODS: Using a within-subject design, we surveyed 1810 individuals from the US general population, administering PROMIS PF8c at survey beginning and end. The order of measure presentation was randomly assigned. We calculated recall difference scores (RDSs) as no recall score minus 7-day recall score using both item response theory-based T scores and raw summed scores. We examined the distribution and created Bland-Altman plots for both RDSTscore and RDSRaw. We also calculated correlations between no recall versus 7-day recall T score and raw scores. Finally, we determined whether differences in no recall versus 7-day recall scores were associated with patient-reported PF. RESULTS: RDSTscore and RDSRaw had means (root mean square differences) of 0.00 (5.43) and -0.04 (3.79), respectively. The vast majority (%) of RDSTscore and RDSRaw values fell between the Bland-Altman limits of agreement (-10.65 to 10.66 and -7.46 to 7.38, respectively). Pearson's correlations between no recall and 7-day recall for T scores and raw scores were 0.88 and 0.87, respectively. Effect sizes for mean RDSTscore and RDSRaw compared across level of Eastern Oncology Cooperative Group performance status, patient global impression of PF severity, and single PF items were near 0. CONCLUSIONS: We did not find any significant recall period effect on PF8c responses. Therefore, we recommend the use of the PROMIS physical function standard, with no specified recall time period.

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.

How do patients interpret and respond to a single-item global indicator of cancer treatment tolerability?

BACKGROUND: There is increasing interest in patient-reported measures of cancer treatment tolerability. A global measure of bother, the FACT GP5 item ("I am bothered by side effects of treatment") is potentially useful for regulatory, research, and clinical use. To understand this item's appropriateness for capturing treatment tolerability, we conducted cognitive interviews on this item with 3 samples of cancer patients. METHODS: Patients with ovarian cancer (Study 1: N = 21; on treatment), lymphoma (Study 2: N = 14; on treatment), and colorectal or lung cancer (Study 3: N = 16; treatment naïve) were interviewed about GP5's understandability and relevance to their treatment side effects. What patients think about when answering GP5 was also assessed. In all studies, the interview included both structured and open-ended questions. Qualitative data were coded to extract themes and responses to structured questions were tallied. RESULTS: Most patients on treatment (Studies 1 and 2) reported that the GP5 item wording is appropriate (88%) and its meaning is clear (97%). They were very confident or confident in their response (97%) and stated that GP5 was relevant to their cancer experience (97%). When answering GP5, patients considered their treatment and specific side effects. A large proportion (40%) of the treatment-naïve (Study 3) patients reported that GP5 was not relevant to their cancer treatment, and the largest proportion responded to GP5 thinking of negative side effect expectancies. CONCLUSION: This study provides assurance that GP5 is a useful indicator of treatment tolerability, and is meaningful to people with cancer, especially once they have started treatment.

Fostering Interdisciplinary Boundary Spanning in Health Communication: A Call for a Paradigm Shift.

Scholarship in the field of health communication is broad, with interdisciplinary contributions from researchers trained in a variety of fields including communication, nursing, medicine, pharmacy, public health, and social work. In this paper, we explore the role of "health communication boundary spanners" (HCBS), individuals whose scholarly work and academic appointment reflect dual citizenship in both the communication discipline and the health professions or public health. Using a process of critical reflective inquiry, we elucidate opportunities and challenges associated with HCBS across the spectrum of health communication in order to provide guidance for individuals pursuing boundary spanning roles and those who supervise and mentor them. This dual citizen role suggests that HCBS have unique skills, identities, perspectives, and practices that contribute new ways of being and knowing that transcend traditional disciplinary boundaries. The health communication field is evolving in response to the need to address significant healthcare and policy problems. No one discipline has the ability to single-handedly fix our current healthcare systems. Narrative data from this study illustrate the importance of seeing HCBS work beyond simply being informed by disciplinary knowledge. Rather, we suggest that adapting ways of knowing and definitions of expertise is an integral part of the solution to solving persistent health problems.

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.

Does recall period matter? Comparing PROMIS® physical function with no recall, 24-hr recall, and 7-day recall.

PURPOSE: To evaluate the influence of recall periods on the assessment of physical function, we compared, in cancer and general population samples, the standard administration of PROMIS Physical Function items without a recall period to administrations with 24-hour and 7-day recall periods. METHODS: We administered 31 items from the PROMIS Physical Function v2.0 item bank to 2400 respondents (n = 1001 with cancer; n = 1399 from the general population). Respondents were randomly assigned to one of three recall conditions (no recall, 24-hours, or 7-days) and one of two "reminder" conditions (with recall periods presented only at the start of the survey or with every item). We assessed items for potential differential item functioning (DIF) by recall time period. We then tested recall and reminder effects with analysis of variance controlling for demographics, English fluency, and co-morbidities. RESULTS: Based on conservative pre-set criteria, no items were flagged for recall time period-related DIF. Using analysis of variance, each condition was compared to the standard PROMIS administration for Physical Function (no recall period). There was no evidence of significant differences among groups in the cancer sample. In the general population sample, only the 24-hour recall condition with reminders was significantly different from the "no recall" PROMIS standard. At the item level, for both samples, the number of items with non-trivial effect size differences across conditions was minimal. CONCLUSIONS: Compared to no recall, the use of a recall period has little to no effect upon PROMIS physical function responses or scores. We recommend that PROMIS Physical Function be administered with the standard PROMIS "no recall" period.

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.

Further content validation of the 18-item NCCN/FACT Ovarian Symptom Index and its Disease Related Symptom-Physical (DRS-P) subscale for use in advanced ovarian cancer clinical trials.

BACKGROUND: This study evaluated pre-defined aspects of content validity of the 18-item NCCN FACT-Ovarian Symptom Index (NFOSI-18) and its Disease-Related Symptoms-Physical (DRS-P) subscale, as clinical trial outcome tools for patients with advanced ovarian cancer. METHODS: Twenty-one women (mean age 59.5 years) diagnosed with advanced ovarian cancer completed the NFOSI-18 and participated in a cognitive interview to explore: (1) whether 'pain' and 'cramps' are considered redundant; (2) whether 'fatigue' and 'lack of energy' are overlapping concepts; (3) whether patients consider severity when responding to the item "I am bothered by constipation;" and (4) factors considered when responding to the item "I am sleeping well." Interviews were audio-recorded, transcribed, and analyzed qualitatively. RESULTS: Pain was associated with discomfort, hurt, and life interference; 'cramps' was associated with pain, muscle tightening, and menstrual or digestive issues. Most (81%) considered the items "I have pain" and "I have cramps in my stomach area" to be more different than similar. Participants associated 'fatigue' with intense tiredness and 'lack of energy' with motivation and capability to complete daily activities. Item comparisons revealed a majority (65%) considered the items to be more different than similar. When responding to "I am bothered by constipation," patients indicated constipation severity was related to bother. Finally, patients considered disease, treatment, and other factors when responding to "I am sleeping well." CONCLUSIONS: Findings support content validity of the NFOSI-18 and its DRS-P as originally constructed. We propose an alternative scoring option that excludes the item "I am sleeping well" from the DRS-P when used as a symptom-focused index for clinical research in a regulatory context.

Lay Epistemology of Breast Cancer Screening Guidelines Among Appalachian Women.

Recent changes to the U.S. Preventive Services Task Force guidelines for breast cancer screening have contributed to increased patient uncertainty regarding the timing and appropriateness of screening behaviors. To gain insight into the lay epistemology of women regarding breast cancer screening practices, we conducted in-depth, face-to-face interviews with 24 adult women living in a medically underserved Appalachian region. We found that women were unaware of breast cancer screening guidelines (i.e., start age, frequency, stop age). Qualitative analysis revealed two lay epistemological narratives establishing (a) uncertain knowledge and ambiguity about breast cancer screening guidelines but certain knowledge of other women's experiences with breast cancer diagnoses, and (b) feelings of knowing one's own body best and seeing the value in "overscreening" to save even one life. Our findings have theoretical and practical implications for scholars and practitioners seeking to improve knowledge or behavior regarding adherence to breast cancer screening recommendations.

Normative Social Support in Young Adult Cancer Survivors.

Following a cancer diagnosis, young adults (YAs; that is, 18-39) often experience altered social relationships with family, friends, romantic partners, and peers. In light of the social struggles YA patients and survivors report due to cancer's biographical disruption, we elicited narratives from 30 YA cancer survivors to examine how their normative perceptions of social support functioned to hinder and assist them in coping with the cancer experience. Through thematic narrative analysis of their individual accounts, YA survivors explained why and how they perceived various support attempts from peers and loved ones to be effective (i.e., being treated "normally"), ineffective (i.e., receiving pity, negative stories, rudeness, excessive self-monitoring, and returns from estrangement), and both effective and ineffective (e.g., instrumental and relational support) in integrating cancer into their biographies. Implications for the advancement of interpersonal communication theory and for the development of age-appropriate communication interventions, educational programs, and informational resources are discussed.

Using communication to manage uncertainty about cervical cancer screening guideline adherence among Appalachian women.

Changes to the United States Preventive Services Task Force (USPSTF) recommendations for cervical cancer preventive services have led to patient confusion, especially in medically underserved populations. We investigated how patient uncertainty concerning cervical cancer screening guidelines is appraised and managed through communication with healthcare providers by conducting in-depth, face-to-face interviews with 24 adult women between the ages of 24 and 65 (m = 41, SD = 14) living in Appalachia Kentucky. In general, participants expressed a high degree of uncertainty about the updated cervical cancer screening guidelines and appraised this uncertainty as both a danger and an opportunity. Communication with healthcare providers served both to exacerbate and to mitigate patient uncertainty. The study identifies how health care providers may use the change in USPSTF guidelines as a 'teachable moment' to productively counsel patients on the importance of timely screening, the typical progression of certain types of high-risk HPV infection to cervical cancer, and the importance of follow-up care.

"It is the 'starting over' part that is so hard": Using an online group to support hospice bereavement.

OBJECTIVE: Although hospice agencies are required to provide informal caregivers (family or friends of the patient) with formal bereavement support when their loved one passes, most bereavement interventions lack standardization and remain untested. We employed the Dual Processing Model of Bereavement as a theoretical framework for assessing the potential of a secret Facebook group for bereaved hospice caregivers. METHOD: A mixed-methods approach was utilized to analyze online communication (posts and comments) in the secret Facebook group, and self-reported outcome measures on depression and anxiety were compared pre- and post-intervention. RESULTS: Sixteen caregivers participated in the secret Facebook group over a period of nine months. The majority of online talk was oriented to restoration, revealing abrupt and anticipated triggers that evoked feelings of loss. Caregivers also shared loss orientation through storytelling, sharing and giving advice, and encouraging others to manage the challenges of coping. Caregiver anxiety and depression were lower after the intervention. SIGNIFICANCE OF RESULTS: This pilot study provides insight into the use of a secret Facebook group to facilitate bereavement support to caregivers. Findings highlight the promise of Facebook for hospice bereavement support. Providers and researchers are encouraged to explore the positive outcomes associated with bereavement support.

Understanding social support burden among family caregivers.

Despite the abundance of research on social support, both as a variable in larger studies and as a central focus of examination, there is little consensus about the relationship between social support and health outcomes. Current social support measures typically account only for frequency and size of network, and a paucity of research exists that has explained social support burden, defined as the burden associated with accessing and receiving support from others. We analyzed audio-recorded discussions by hospice family caregivers about their caregiving problems and potential solutions to examine social relationships within networks and identify the processes that influence social support seeking and receiving. Using qualitative thematic analysis, we found that caregivers providing hospice care experience social support burden resulting from perceived relational barriers between friends and family, the inclination to remain in control, recognition of the loss of the patient as a source of social support and guidance in decision making, family dynamics, and decreased availability of emotional support. Social support researchers should consider how the quality of communication and relationships within social networks impacts the provision and subsequent outcomes of social support in varying contexts. Findings from this study suggest that hospice social support resources should be tailored to the caregiver's support needs and include assessment on the type of support to be offered.

Content validation of the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (NFLymSI-18) in indolent B-cell non-Hodgkin's lymphoma.

BACKGROUND: The NFLymSI-18 is a patient-reported outcome measure comprised of the highest priority symptoms, emotional concerns, treatment side effects, and other concerns identified by lymphoma patients and oncologists. This study assessed the content validity of the NFLymSI-18 for patients with indolent B-cell non-Hodgkin's lymphoma (iNHL), with a focus on the Disease-Related Symptoms Physical (DRS-P) subscale. METHODS: Patients with a confirmed iNHL diagnosis who had received one or more lines of treatment were recruited during clinic visits. Patients described their symptoms, treatment side effects, and emotional concerns related to iNHL in a semi-structured interview. Qualitative data were analyzed using NVivo10. RESULTS: Data saturation was obtained by the 18th interview. Most participants (67%) had follicular lymphoma. 28% of participants had marginal zone lymphoma, and one participant had lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia. Mean age of the 18 participants was 67 years. 56% of the sample was male. Most participants (67%) had a college or advanced degree. When asked to describe their iNHL symptoms, patients most often discussed swelling (n = 14), fatigue (n = 11), and pain (n = 8). The following symptoms were mentioned by three patients each: anxiety, appetite loss, rash, sleep disruption, trouble breathing, and malaise. Mapping of NFLymSI-18 content to these concerns showed the instrument includes all those most frequently mentioned symptoms. CONCLUSIONS: This study supports the content validity of the NFLymSI-18, including its DRS-P Subscale, for patients with iNHL. The instrument shows strong validity for the most referenced symptoms of swelling, fatigue, and pain. The diversity of additional symptoms reported by patients is consistent with the heterogeneous symptomology of iNHL.

Obstacles to Biosimilar Acceptance and Uptake in Oncology: A Review.

Importance: Biosimilar drugs provide cost-effective yet clinically indistinguishable replications of target drugs. During initial development, this class of biologic medicines was expected to revolutionize pharmaceutical markets; however, following US Food and Drug Administration approval of the first biosimilar drug in 2015, the commercialization of biosimilars has been limited. The lack of biosimilar use may be especially salient in oncology, given that biosimilar distribution in this particularly high-cost area of medicine would bring savings on the order of many billions of dollars. Observations: While researchers have focused on salient economic barriers to biosimilar uptake in the US, the present review provides insight regarding noneconomic barriers. This review discusses psychological, attitudinal, and educational factors among both health care professionals and payers in the US that may play a role in slowing biosimilar uptake. More specifically, these factors include a lack of health care professional education, concerns of safety and efficacy, and overly complex product naming systems. Conclusions and Relevance: The pathway to biosimilar use has been obstructed by economic elements as well as attitudinal and psychological factors. For biosimilar drugs to achieve their potential in decreasing treatment costs and thus increasing patient access, it will be essential for both economic and noneconomic factors to be identified and systematically addressed.

Parental self-efficacy managing a child's medications and treatments: adaptation of a PROMIS measure.

PURPOSE: Self-efficacy is important for managing chronic conditions; however, its measurement in pediatric healthcare settings remains rare. The goal of this project was to adapt an existing disease-agnostic adult self-efficacy patient reported outcome (PRO) measure to enhance suitability of items for measuring the self-efficacy of parents that manage their children's health conditions. METHODS: We adapted the existing Patient-Reported Outcomes Measurement Information System® (PROMIS®) adult self-efficacy healthcare measure to parental voice. First, a targeted literature review informed rephrasing of the adult items and identification of new pediatric-specific content. The initial item pool was revised based on input from 12 multidisciplinary experts. Next cognitive interviews of adapted items were simultaneously conducted with English and Spanish-speaking parents of pediatric patients with a range of chronic and/or disabling conditions recruited from a Midwestern children's hospital to finalize the measure. RESULTS: Findings resulted in an initial item pool of 33 pediatric-specific items which were narrowed to 31 draft items based on expert input. Parent cognitive interview findings (N = 26) informed further item reduction resulting in a final measure consisting of 30 items representing nine domains. Fourteen items are relevant to children regardless of condition severity (e.g., health care information/decision making; symptom identification/management) and 16 items are relevant to children with specific health care needs (e.g., medication usage, equipment). CONCLUSION: We conducted a first step in developing a condition-agnostic, PRO measure of parental self-efficacy managing their children's chronic and/or disabling conditions that is acceptable and understandable to English and Spanish-speaking parents.

Self-efficacy, which is someone's confidence in completing a task, is important for managing a chronic health condition. Knowing parents' self-efficacy managing their children's health conditions may be an important step in supporting their children's health but no single measure is available for diverse sets of conditions. In this paper, we present the development of a new patient reported outcomes measure designed to assess self-efficacy of parents managing their child's chronic and/or disabling conditions. We found that the measure is both acceptable and understandable to English and Spanish speakers and may be useful to proactively identify parents in need of additional supports at hospital discharge or at the time of a new diagnosis.

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.

Monitoring Adverse Effects of Radiation Therapy in Patients With Head and Neck Cancer: The FACT-HN-RAD Patient-Reported Outcome Measure.

Importance: Patients undergoing radiation therapy (RT) for head and neck squamous cell carcinoma (HNSCC) experience a range of debilitating adverse effects (AEs). Patient-reported outcome (PRO) measures to quantify these AEs are a necessary and important component of health care; however, currently available PRO options often measure only disease-related symptoms or AEs of non-RT treatments. Objective: To develop a brief PRO measure of the most common AEs associated with RT for HNSCC. Design, Setting, and Participants: This was a qualitative study that followed the US Food and Drug Administration guidelines to develop a brief measure of patient-reported RT-related AEs (the Functional Assessment of Cancer Therapy-Head and Neck Radiotherapy [FACT-HN-RAD] measure). The study included (1) a literature review of clinical trials; (2) secondary analysis of retrospective concept elicitation interviews (CEIs); (3) electronic surveys of practicing radiation oncologists; (4) mapping of existing items to inform the development of the draft version of the measure; and (5) validation of content and face validity via patient cognitive interviews. Analysis was performed of CEI data and interviews with practicing radiation oncologists. Data analysis was conducted from July 1, 2022, to April 21, 2023. Exposures: Surveys and qualitative interviews. Main Outcomes and Measures: The most common patient-reported RT-related AEs among patients with HNSCC. Results: Of 19 CEI participants, 14 (mean [range] age, 67 [49-86] years; 12 [86%] men and 2 [14%] women) described RT-related AEs and were included in the secondary analysis. Eleven (79%) patients reported difficulty swallowing; 8 (57%), oral pain; 7 (50%), dry mouth; 7 (50%), weight loss; 6 (43%), skin burning; 5 (36%), loss of taste; 5 (36%), voice changes (36%); and 5 (36%), fatigue. Nine radiation oncologists (mean [range] time in practice, 8 [1-42] years; 5 [56%] men and 4 [44%] women) reported the most common AEs: 9 (100%) reported dysgeusia; 7 (78%), xerostomia; 7 (78%), mucositis or oral pain; 8 (89%), dysphagia or odynophagia; 6 (67%), dermatitis; and 3 (33%), fatigue. Together these data informed the development of an 8-item AE-focused measure of pain, dysphagia, xerostomia, dysgeusia, voice changes, dermatitis, fatigue, and weight loss. Cognitive interviews with 10 patients (mean [range] age, 61 [29-84] years; 8 [80%] men and 2 [20%] women) demonstrated strong face validity; all (100%) reported that the measure reflected their experience with RT and stated that the length of the questionnaire was "just right." Conclusions and Relevance: The 8-item FACT-HN-RAD measure captures the most common patient- and physician-reported AEs related to RT for HNSCC. This measure offers a means to serially monitor patient-reported treatment-related AEs and recovery over time in both clinical and research settings. Future work will evaluate the psychometric validity of the measure.