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Karen Kaiser,1 Susan E Yount,1 Christa E Martens,1 Kimberly A Webster,1 Sara Shaunfield,1 Amy Sparling,1 John Devin Peipert,1 David Cella,1 Scott T Rottinghaus,2 Bonnie MK Donato,2 Richard Wells,3 Ioannis Tomazos2 1Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; 2Alexion Pharmaceuticals Inc, Boston, MA, USA; 3Sunnybrook Health Sciences Centre, Toronto, ON, CanadaCorrespondence: Karen KaiserDepartment of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 625 N. Michigan Ave. Suite 2700, Chicago, IL 60611, USATel +1 312-503-3521Fax +1 312-503-4800Email k-kaiser@northwestern.eduPurpose: To develop a patient preference questionnaire (PPQ) assessing eculizumab and ravulizumab treatment for paroxysmal nocturnal hemoglobinuria (PNH).Patients and Methods: The development of the PNH-PPQ© was consistent with Food and Drug Administration guidelines for patient-reported outcome measure development, and included 1) a targeted literature review; 2) PNH expert clinician input on treatment preferences; 3) review of existing qualitative data on the PNH treatment and disease experience; 4) concept elicitation interviews with 8 PNH patients who received eculizumab and/or ravulizumab; 5) translatability review; and 6) cognitive debriefing with 5 patients. Interview participants were recruited through a United Kingdom PNH patient advocacy group and a Canadian clinical site involved in clinical trial ALXN1210-PNH-302.Results: Six themes were identified as most relevant to the PNH treatment experience from the concept elicitation interviews: disease symptoms (n=8/8); treatment frequency (n=7/8); quality of life impact of treatment/disease (n=7/8); treatment burden (n=7/8); treatment efficacy (n=5/8); and treatment side effects (n=5/8). An initial list of 88 preference questions was reduced to 11 highly relevant and non-redundant questions reflecting the 6 themes. Cognitive interview participants unanimously agreed that the PNH-PPQ instructions were clear; response options were understandable, easy to use, and provided enough choices; and the questions captured the factors that inform treatment preferences.Discussion: When new drugs have similar efficacy to existing medications, documenting patient preferences is important for confirming patient benefit from the new medication. Understanding what matters most to patients is essential for delivering patient-centered care and may play a particularly significant role in treatment decision making. The availability of such a tool may be especially important as new orphan drugs are developed and patients with rare diseases have more than one treatment option to consider.Conclusion: The PNH-PPQ provides a patient-centered approach for evaluating preferences for the treatment of PNH. The PNH-PPQ has subsequently assessed patient preference in the clinical trial sub-study ALXN1210-PNH-302s.Keywords: paroxysmal nocturnal hemoglobinuria, questionnaire development, ravulizumab, eculizumab, treatment experience

Summary: Background: Itch is a cardinal feature of paediatric disorders and can impair quality of life. However, few studies have addressed symptoms and impacts of itch in paediatric patients. Objectives: We focused on understanding the child's experience of itch and the impact of itch specifically on affected children, including comparison with the adult experience. Methods: Semistructured interviews (nine parents, 15 children with itch) explored concerns related to paediatric itch experiences and effects. Themes were compared with those of previous adult interviews. Literature was reviewed to identify the need for a more comprehensive measure of paediatric itch. Results: Itch quality, intensity, duration and environmental triggers (sweating, climate change, stress and certain fabrics) are important aspects of the child's itch experience. Skin disruption, physical function, concentration, emotional reactions, stigma and relationships/social effects are itch impact themes that emerged. No paediatric‐specific scale comprehensively captures the paediatric patient itch experience. However, differences between child and adult reports of itch‐related pain, functional limitations, fatigue and restlessness, emotional reactions to itch, and treatment effects emphasize the need for a paediatric‐specific measurement tool. Conclusions: Children and parents endorse the importance of capturing the paediatric‐focused characteristics and impacts of itch in measuring disease severity and response to intervention. What is already known about this topic?Most children with pruritic disorders in the clinic or in clinical trials are asked a single question about itch intensity, if asked at all.However, the many negative impacts of itch in paediatric patients with atopic dermatitis and other pruritic disorders have not been well characterized and may differ from those in adults with pruritic disorders. What does this study add?Itch quality, duration and triggers are important itch characteristics, in addition to itch intensity, in understanding the itch experience and managing itch.While itch can lead to physical manifestations, such as excoriations and a risk of cutaneous infection, other important impacts include reduced physical function and ability to concentrate, disruption of social relationships, and increased stigma and emotional reactions. What are the clinical implications of this work?To comprehensively understand itch, practitioners should ask questions about itch‐related impacts on physical, mental and emotional health.An instrument that quickly assesses severity of itch symptoms and itch impacts in clinical practice is needed and can be based on the conceptual framework generated in this qualitative study.Given the differences between the itch experience in adults and children, a paediatric‐specific tool should be developed. Linked Comment: Zigler and Roberts. Br J Dermatol 2021; 184:795–796. [ABSTRACT FROM AUTHOR]

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., (© 2024. The Author(s).)

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.

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.

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.

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., (© 2023. The Author(s).)

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., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Objective: No validated tools exist to measure pediatric home healthcare quality. The objective of this work was to develop a family-reported survey (PediHome) to measure the quality of home healthcare for children with medical complexity (CMC)., Methods: A national multidisciplinary expert panel (N = 19) was convened to develop survey content domains. Panelist were joined by 3 additional experts to rank candidate survey items for importance and evaluate relevance and structure. Cognitive interviews were conducted with English-speaking (n = 12) and Spanish-speaking (n = 4) family caregivers of CMC to revise problematic items and clarify response options. A cross-sectional survey was then fielded (6/1/20-10/31/20) to parents whose children receive healthcare at 2 regional academic medical centers., Results: The final measure included N = 28 total items with 4 items quantifying access, 1 evaluating overall quality rating, and 21 items assessing provider tasks (11 home nursing only, 2 certified nursing assistant/home health aide only, and 1 dual). Out of 312 caregivers of CMC, 142 (46%) responded and one-half (n = 68, 48%) reported a child receiving home nursing. They received a weekly median of 58.4% (IQR ±31.2%) of approved nursing hours with 55% reporting a missed nursing shift within the last month. Median overall quality was 75-9 (0-10 scale) and median scores on specific quality items ranged from 31 - 4 to 43 - 4 (0-4 scale)., Conclusions: PediHome is a new content-valid family-reported measure of home healthcare quality for CMC that is useful for evaluating healthcare quality across several domains. Future work will involve assessing PediHome's construct and predictive validity., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

This qualitative study evaluated barriers and facilitators to mobility in the homes of children with medical complexity (CMC) and the subsequent impact on CMC and their families. Eighteen caregivers of CMC were interviewed. Parents described that accessibility barriers impaired delivery of care at home and impacted the child's participation in family life. The most inaccessible areas were stairs and bathrooms. Mobility and transfers became more difficult as children grew larger. Parents and children sustained injuries from performance of activities of daily living (ADLs). When available, durable medical equipment (DME) and home modifications improved home access and typically were funded using insurance and state Title V funds. However, parents reported that larger home modifications, such as bathroom modifications, were cost prohibitive. A pediatrician's inquiry about mobility barriers may reveal crucial information about delivery of home care to CMC. CMC may be referred to rehabilitation specialists to address mobility needs.

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., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

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.

Introduction: We sought to characterize the current supports used by parents to care for children with medical complexity (CMC) at home and parental preferences for additional supports to meet identified gaps., Method: Semistructured interviews were conducted with parents of 18 CMC. Interviews were transcribed then analyzed using a constant comparative approach., Results: Extended family and community offloaded nonmedical tasks, assisted financially, gave emotional reinforcement, and cared for CMC. Home health providers also directly cared for CMC, but access and quality varied. Government programs paid for in-home care, but eligibility varied. Parents wanted more paid home care but also more support completing nonmedical tasks, mitigating financial strains, and accessing mental health services., Discussion: Parents of CMC relied on family and community members to help fill existing gaps in-home care, but gaps remained, suggesting the need for more medical and social supports for the in-home care of CMC and their families., (Copyright © 2020 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.)

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 RDS Tscore and RDS Raw . 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: RDS Tscore and RDS Raw had means (root mean square differences) of 0.00 (5.43) and -0.04 (3.79), respectively. The vast majority (%) of RDS Tscore and RDS Raw 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 RDS Tscore and RDS Raw 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., (Copyright © 2021 ISPOR–The International Society for Pharmacoeconomics and Outcomes Research, Inc. Published by Elsevier Inc. All rights reserved.)

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.

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., (© 2021. Society of General Internal Medicine.)

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., Competing Interests: Authors Shaunfield, Yount, Boyken, and Cella received research funding from Daiichi Sankyo. Agulnik serves as a consultant for the following companies: Eisai, Inc., Eli Lilly and Company, Novartis, and Janssen Pharmaceuticals Inc.; Samant has investment interest in Y‐Trap Inc.; Cella is the President of FACIT.org and serves as a consultant to Pfizer, Novartis, and AbbVie Inc., (© 2021 The Authors. Health Science Reports published by Wiley Periodicals LLC.)

Background: Electronic medication monitoring (EMM) is a digital tool that can be used for tracking daily medication use. Previous studies of EMM in asthma management have been conducted in adults or have examined pediatric interventions that use EMM for less than 1 year. To understand how to improve EMM-enhanced interventions, it is necessary to explore the experiences of parents of children with asthma, recruited from outpatient practices, who completed a 12-month intervention trial., Objective: The objective of our study was to use qualitative inquiry to answer the following questions: (1) how did using an EMM-enhanced intervention change parents'/caregivers' experiences of managing their child's asthma, and (2) what do parents recommend for improving the intervention in the future?, Methods: Parents were recruited from the intervention arm of a multicomponent health intervention enhanced by Bluetooth-enabled sensors placed on inhaler medications. Semistructured interviews were conducted with 20 parents of children aged 4-12 years with asthma. Interviews were audio-recorded, transcribed, and inductively analyzed using a constant comparative approach., Results: Interview participants reflected an even mix of publicly and privately insured children and a diverse racial-ethnic demographic. Parents discussed 6 key themes related to their experience with the EMM-enhanced intervention for the management of their child's asthma: (1) compatibility with the family's lifestyle, (2) impact on asthma management, (3) impact on the child's health, (4) emotional impact of the intervention, (5) child's engagement in asthma management with the intervention, and (6) recommendations for future intervention design. Overall, parents reported that the 12-month EMM intervention was compatible with their daily lives, positively influenced their preventive and acute asthma management, and promoted their child's engagement in their own asthma management. While parents found the intervention acceptable and generally favorable, some parents identified compatibility issues for families with multiple caregivers and frustration when the technology malfunctioned., Conclusions: Parents generally viewed the intervention as a positive influence on the management of their child's asthma. However, our study also highlighted technology challenges related to having multiple caregivers, which will need to be addressed in future iterations for families. Attention must be paid to the needs of parents from low socioeconomic households, who may have more limited access to reliable internet or depend on other relatives for childcare. Understanding these family factors will help refine how a digital tool can be adopted into daily disease management of pediatric asthma., (©Kristin Kan, Sara Shaunfield, Madeleine Kanaley, Avneet Chadha, Kathy Boon, Carolyn C Foster, Luis Morales, Patricia Labellarte, Deneen Vojta, Ruchi S Gupta. Originally published in JMIR Pediatrics and Parenting (https://pediatrics.jmir.org), 23.04.2021.)

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., (© 2020 S. Karger AG, Basel.)

Current patient-reported outcome measures for itch are limited and may not capture its full impact on health-related quality of life. We sought to develop, calibrate, and validate banks of questions assessing the health-related quality of life impact of itch as part of the Patient-Reported Outcomes Measurement Information System. A systematic process of literature review, content-expert review, qualitative research, testing in a sample of 600 adults, classical test theory methods, and item response theory analyses were applied. Exploratory and confirmatory factor analyses were followed by item response theory model and item fit analyses. Four itch-related item banks were developed: (i) general concerns, (ii) mood and sleep, (iii) clothing and physical activity, and (iv) scratching behavior. Item response theory and expert content review narrowed the item banks to 25, 18, 15, and 5 items, respectively. Validity of the item banks was supported by good convergent and discriminant validity with itch intensity, internal consistency, and no significant floor or ceiling effects. In conclusion, the Patient-Reported Outcomes Measurement Information System Itch Questionnaire banks have excellent measurement properties and efficiently and comprehensively assess the burden of itch., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

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.

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., Competing Interests: Conflict-of-interest statement: The authors have no conflicts of interest to declare., (©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.)

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.

Preoperative expectations impact shared decision making and patient satisfaction. Surgeon views of patient selection, expected outcomes and patient expectations after periacetabular osteotomy (PAO) for treatment of acetabular dysplasia have not been defined. We assessed surgeon views of patient selection and expected outcomes after PAO. A sample of experienced PAO surgeons participated in semi-structured phone interviews assessing: (i) factors that determine patient candidacy for PAO; (ii) surgeon expectations for PAO outcomes; (iii) surgeon perceptions of patient expectations for PAO outcomes and (iv) surgeon perceptions of discrepancies in surgeon and patient expectations and approaches for reconciling these discrepancies. Twelve surgeons (77% of PAO-performing ANCHOR surgeons) participated. The factors most commonly mentioned in determining patient candidacy for PAO were: symptoms, radiographic findings, absence of arthritis and age. Only one-quarter of the sample mentioned patient expectations as a factor in determining patient candidacy for PAO. The most common surgeon expectations were: pain reduction, joint preservation, function with activities of daily living and return to desired activities. 58% of surgeons felt that surgeon and patient expectations align most of the time. Common expectation discrepancies included return to unrestricted activities and complete pain relief. Detailed discussion was the most commonly employed strategy to resolve expectation discrepancies. PAO surgeons felt that patient expectations of complete pain relief and return to unrestricted activities were misaligned with their own expectations. Development of an expectations survey may facilitate shared decision making., (© The Author(s) 2019. Published by Oxford University Press.)

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.

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.

Background: While effective communication is important in the care of seriously ill patients, little is known about communication challenges faced by healthcare providers serving U.S. patients of South Asian origin, one of the fastest growing demographic groups in the United States., Objective: Researchers sought to examine communication challenges faced by healthcare providers serving seriously ill South Asian patients and their families and present strategies recommended by providers for effective communication., Design: Researchers conducted a thematic analysis of qualitative data obtained through focus groups and individual interviews with 57 healthcare providers, including physicians, social workers, nurses, chaplains, and others drawn from different healthcare settings in one Midwestern city., Results: While acknowledging the considerable diversity within the U.S. South Asian community, participants discussed three types of communication challenges they often encounter when serving this population: ensuring effective interpretation, identifying a spokesperson, and challenges posed by different cultural norms. Participants shared strategies to address these challenges such as proactively inquiring about patients' and families' preferences and encouraging early appointment of a spokesperson., Conclusions: While providers should avoid stereotyping patients, an awareness of common challenges and adoption of recommended strategies to address these challenges may enhance the provision of culturally responsive person-centered services for seriously ill South Asian patients and their families receiving care in the United States.

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.

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.

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.

Background: The ACTIVE (Assessing Caregivers for Team Intervention through Video Encounters) intervention uses technology to enable family caregivers to participate in hospice interdisciplinary team (IDT) meetings from geographically remote locations. Previous research has suggested that effective communication is critical to the success of these meetings. The purpose of this study was to explore communication in ACTIVE IDT meetings involving family caregivers and to assess the degree to which hospice teams use specific communication principles (summarized in the mnemonic VALUE: value, acknowledge, listen, understand, and elicit), which have been supported in previous research in intensive care settings., Methods: Researchers analyzed team-family communication during 84 video- and/or audio-recorded care plan discussions that took place during ACTIVE team meetings, using a template approach to text analysis to determine the extent and quality of VALUE principles. The total content analyzed was 9 hours, 28 minutes in length., Results: Hospice clinicians routinely employed the VALUE communication principles in communication during ACTIVE IDT meetings with family caregivers, but the quality of this communication was frequently rated moderate or poor. The majority of such communication was task-focused. Less often, communication centered on emotional concerns and efforts to gain a more holistic understanding of patients and families., Conclusions: This analysis suggests an opportunity for improving support for family members during ACTIVE IDT meetings. Members of hospice IDTs should remain aware of the opportunity for additional attention to the emotional realities of the hospice experience for family caregivers and could improve support for family caregivers during IDT meetings by ensuring that messages used to exemplify VALUE principles during team-family communication are of a high quality.

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., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Although hospice volunteer programs contribute to patient care, little is known about their utilization and adaptation of technology. A survey was posted to the Hospice Volunteer Association Web site to assess technology use among volunteer coordinators and volunteers. Results revealed that participants have access to computers, Internet, and e-mail at the hospice agency and routinely use cellular phones and e-mail. Despite the use of technology, communication problems with volunteers hindered the coordinator's ability to manage scheduling, training, and volunteer assignments for patient care. Coordinators and volunteers felt comfortable utilizing technology but were less comfortable using technology in the patients' home. Several areas are identified for development and integration of advanced technology in volunteer programs. Future research is needed to ease technology implementation and increase volunteer acceptance.

Care interventions are not routinely provided for hospice caregivers, despite widespread documentation of the burden and toll of the caregiving experience. Assessing caregivers for team interventions (ACT) proposes that holistic patient and family care includes ongoing caregiver needs assessment of primary, secondary, and intrapsychic stressors. In this study, our goal was to describe the variance in stressors for caregivers to establish evidence for the ACT theoretical framework. We used secondary interview data from a randomized controlled trial to analyze hospice caregiver discussions about concerns. We found variances in stress types, suggesting that caregiver interventions should range from knowledge and skill building to cognitive-behavioral interventions that aid in coping. Family members who assume the role of primary caregiver for a dying loved one need to be routinely assessed by hospice providers for customized interventions.

Limited attention to palliative care communication training is offered to medical students. In this work, we pursued unfolding case responses and what they indicated about student tendencies to use palliative care communication as well as what medical students can learn from their own reflective practice about palliative care. Findings showed an overwhelming trend for students to avoid palliative care communication or inclusion of topics including advance directives, place of care, family support, and dying. Instead, students relied heavily on the SPIKES protocol, communication that was strategically vague and ambiguous, and discussions that centered on specialty care and referral. In reflecting on their own case study responses, students noted an absence of direct communication about prognosis, no coordination of care, late hospice entry, and patient pain resulting from communication inefficacies. Future research should focus on the development of formal and adaptive curriculum structures to address these communication needs.

Growing numbers of terminally ill older adults receive hospice services in adult family homes (AFHs); however, little is known about the provision and receipt of end-of-life care in such environments. This article reports findings from a qualitative exploration of family members' perspectives of the hospice experience in AFHs. Analysis of data obtained during interviews of 15 residents' family members exposed significant challenges associated with transition to an AFH, highlighted the importance of AFH and hospice staff in family members' assessment of overall quality of care, and emphasized the critical nature of communication in AFH settings.

Unlabelled: As palliative care coursework continues to proliferate within US medical education, novel curriculum approaches have included the use of cancer survivors and family caregivers. We included bereaved family caregivers in structured clinical teaching., Methods: First year students were exposed to a lecture about death and dying and then met with a bereaved caregiver in small groups of 10-15 for a presentation about the caregiving experience, bereavement, and question and answer period. Substantial pre-planning was involved to recruit caregivers and arrange for classroom space., Results: Participation evoked caregiver anxiety but was resolved with adequate arrangement of the classroom and student introductions., Conclusions: Future implementation of bereaved caregivers in palliative coursework should include an appropriate follow-up phone call as well as recruiting more caregivers than necessary for the curriculum.