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Elizabeth A Rogers,1,2 Kathleen J Yost,3 Jordan K Rosedahl,3 Mark Linzer,4 Deborah H Boehm,5 Azra Thakur,5 Sara Poplau,5 Roger T Anderson,6 David T Eton3 1Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA; 2Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA; 3Department of Health Services Research, Mayo Clinic, Rochester, MN, USA; 4Department of Medicine, Hennepin County Medical Center, Minneapolis, MN, USA; 5Minneapolis Medical Research Foundation, Minneapolis, MN, USA; 6University of Virginia School of Medicine, Charlottesville, VA, USA Aims: To validate a comprehensive general measure of treatment burden, the Patient Experience with Treatment and Self-Management (PETS), in people with diabetes. Methods: We conducted a secondary analysis of a cross-sectional survey study with 120 people diagnosed with type 1 or type 2 diabetes and at least one additional chronic illness. Surveys included established patient-reported outcome measures and a 48-item version of the PETS, a new measure comprised of multi-item scales assessing the burden of chronic illness treatment and self-care as it relates to nine domains: medical information, medications, medical appointments, monitoring health, interpersonal challenges, health care expenses, difficulty with health care services, role activity limitations, and physical/mental exhaustion from self-management. Internal reliability of PETS scales was determined using Cronbach’s alpha. Construct validity was determined through correlation of PETS scores with established measures (measures of chronic condition distress, medication satisfaction, self-efficacy, and global well-being), and known-groups validity through comparisons of PETS scores across clinically distinct groups. In an exploratory test of predictive validity, step-wise regressions were used to determine which PETS scales were most associated with outcomes of chronic condition distress, overall physical and mental health, and medication adherence. Results: Respondents were 37–88 years old, 59% female, 29% non-white, and 67% college-educated. PETS scales showed good reliability (Cronbach’s alphas ≥0.74). Higher PETS scale scores (greater treatment burden) were correlated with more chronic condition distress, less medication convenience, lower self-efficacy, and worse general physical and mental health. Participants less (versus more) adherent to medications and those with more (versus fewer) health care financial difficulties had higher mean PETS scores. Medication burden was the scale that was most consistently associated with well-being and patient-reported adherence. Conclusion: The PETS is a reliable and valid measure for assessing perceived treatment burden in people coping with diabetes. Keywords: treatment burden, patient-reported measure, measurement, patient perspective, disease management

David T Eton,1,2 Jennifer L Ridgeway,1,2 Mark Linzer,3 Deborah H Boehm,4 Elizabeth A Rogers,5 Kathleen J Yost,1,2 Lila J Finney Rutten,1,2 Jennifer L St Sauver,1,2 Sara Poplau,4 Roger T Anderson6 1Department of Health Sciences Research, 2Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, 3Division of General Internal Medicine, Hennepin County Medical Center, 4Minneapolis Medical Research Foundation, 5Division of General Internal Medicine, University of Minnesota Medical School, Minneapolis, MN, 6Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, VA, USA Purpose: Having multiple chronic conditions (MCCs) can lead to appreciable treatment and self-management burden. Healthcare provider relational quality (HPRQ) – the communicative and interpersonal skill of the provider – may mitigate treatment burden and promote self-management. The objectives of this study were to 1) identify the associations between HPRQ, treatment burden, and psychosocial outcomes in adults with MCCs, and 2) determine if certain indicators of HPRQ are more strongly associated than others with these outcomes.Patients and methods: This is a cross-sectional survey study of 332 people with MCCs. Patients completed a 7-item measure of HPRQ and measures of treatment and self-management burden, chronic condition distress, self-efficacy, provider satisfaction, medication adherence, and physical and mental health. Associations between HPRQ, treatment burden, and psychosocial outcomes were determined using correlational analyses and independent samples t-tests, which were repeated in item-level analyses to explore which indicators of HPRQ were most strongly associated with the outcomes.Results: Most respondents (69%) were diagnosed with ≥3 chronic conditions. Better HPRQ was found to be associated with less treatment and self-management burden and better psychosocial outcomes (P

David T Eton,1 Tarig A Elraiyah,2 Kathleen J Yost,3 Jennifer L Ridgeway,1 Anna Johnson,2 Jason S Egginton,1 Rebecca J Mullan,4 Mohammad Hassan Murad,2 Patricia J Erwin,2 Victor M Montori1,2 1Division of Heath Care Policy and Research, Department of Health Sciences Research, 2Knowledge and Evaluation Research Unit, 3Division of Epidemiology, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA; 4University of Minnesota Medical School, Minneapolis, MN, USA Background: Burden of treatment refers to the workload of health care and its impact on patient functioning and well-being. There are a number of patient-reported measures that assess burden of treatment in single diseases or in specific treatment contexts. A review of such measures could help identify content for a general measure of treatment burden that could be used with patients dealing with multiple chronic conditions. We reviewed the content and psychometric properties of patient-reported measures that assess aspects of treatment burden in three chronic diseases, ie, diabetes, chronic kidney disease, and heart failure. Methods: We searched Ovid MEDLINE, Ovid EMBASE, Ovid PsycINFO, and EBSCO CINAHL through November 2011. Abstracts were independently reviewed by two people, with disagreements adjudicated by a third person. Retrieved articles were reviewed to confirm relevance, with patient-reported measures scrutinized to determine consistency with the definition of burden of treatment. Descriptive information and psychometric properties were extracted. Results: A total of 5686 abstracts were identified from the database searches. After abstract review, 359 full-text articles were retrieved, of which 76 met our inclusion criteria. An additional 22 articles were identified from the references of included articles. From the 98 studies, 57 patient-reported measures of treatment burden (full measures or components within measures) were identified. Most were multi-item scales (89%) and assessed treatment burden in diabetes (82%). Only 15 measures were developed using direct patient input and had demonstrable evidence of reliability, scale structure, and multiple forms of validity; six of these demonstrated evidence of sensitivity to change. We identified 12 content domains common across measures and disease types. Conclusion: Available measures of treatment burden in single diseases can inform derivation of a patient-centered measure of the construct in patients with multiple chronic conditions. Patients should take part in developing the measure to ensure salience and relevance. Keywords: patient-reported outcomes, treatment burden, questionnaire, psychometric properties, self-management, patient-centered

Purpose: Individuals diagnosed and treated for cancer often report high levels of distress, continuing even after successful treatment. Spiritual well-being (SpWB) has been identified as an important factor associated with positive health outcomes. This study had two aims: (1) examine the associations between SpWB (faith and meaning/peace) and health-related quality of life (HRQL) outcomes and (2) examine competing hypotheses of whether the relationship among distress, SpWB, and HRQL is better explained by a stress-buffering (i.e., interaction) or a direct (main effects) model.Methods: Study 1 consisted of 258 colorectal cancer survivors (57% men) recruited from comprehensive cancer centers in metropolitan areas (age, M=61; months post-diagnosis, M=17). Study 2 consisted of 568 colorectal cancer survivors (49% men) recruited from a regional cancer registry (age, M=67; months post-diagnosis, M=19). Participants completed measures of SpWB (functional assessment of chronic illness therapy-spiritual well-being (FACIT-Sp)) and HRQL (functional assessment of cancer therapy-colorectal) in both studies. Measures of general distress (profile of mood states-short form) and cancer-specific distress were also completed in study 1 and study 2, respectively.Results: After controlling for demographic and clinical variables, faith and meaning/peace were positively associated with HRQL. However, meaning/peace emerged as a more robust predictor of HRQL outcomes than faith. Planned analyses supported a direct rather than stress-buffering effect of meaning/peace.Conclusions: This study provides further evidence of the importance of SpWB, particularly meaning/peace, to HRQL for people with colorectal cancer. Future studies of SpWB and cancer should examine domains of the FACIT-Sp separately and explore the viability of meaning-based interventions for cancer survivors. [ABSTRACT FROM AUTHOR]

Self-administration of a multimedia health literacy measure in clinic settings is a novel concept. Demonstrated ease of use and acceptability will help predicate the future value of this strategy. We previously demonstrated the acceptability of a "Talking Touchscreen" for health status assessment. For this study, we adapted the touchscreen for self-administration of a new health literacy measure. Primary care patients (n = 610) in clinics for underserved populations completed health status and health literacy questions on the Talking Touchscreen and participated in an interview. Participants were 51% women, 10% age 60+, 67% African American, 18% without a high school education, and 14% without any prior computer experience. The majority (93%) had no difficulty using the touchscreen, including those who were computer-naive (87%). Most rated the screen design as very good or excellent (72%), including computer-naive patients (71%) and older patients (75%). Acceptability of the touchscreen did not differ by health literacy level. The Talking Touchscreen was easy to use and acceptable for self-administration of a new health literacy measure. Self-administration should reduce staff burden and costs, interview bias, and feelings of embarrassment by those with lower literacy. Tools like the Talking Touchscreen may increase exposure of underserved populations to new technologies. [ABSTRACT FROM AUTHOR]

Background: Heterogeneous results for research investigating health-related quality of life (HRQL) in patients undergoing sphincter-ablating procedures for rectal cancer are likely due to single institution experiences and measurement of HRQL. To address this heterogeneity, we evaluated HRQL in patients with rectal cancer by type of surgery, location of tumor, and receipt of adjuvant therapy using an HRQL instrument that has not been used to address rectal cancer patients in a population-based sample over time.Methods: The Functional Assessment of Cancer Therapy-Colorectal instrument was administered at 9 and 19 months after diagnosis to a consecutive sample of 160 patients in Northern California identified by the California Cancer Registry. A broad multidimensional interpretation of HRQL was used to examine the impact of tumor location and treatment status, stage of disease, age, and gender.Results: In general, men had lower social well-being scores, and younger patients had lower physical and emotional well-being scores and colorectal concerns scores. We found no differences in HRQL by either tumor location or type of surgery, at either 9 or 19 months after diagnosis. Lower physical well-being and greater adverse colorectal concerns were reported at 9 months among patients who received adjuvant therapy; however, only adverse colorectal concerns persisted over time.Conclusions: This study provides additional evidence that sphincter-ablating procedures do not necessarily reduce quality of life in patients with rectal cancer. Distinctive features of this study include a broad multidimensional interpretation of HRQL, the 19 months of longitudinal follow-up, and a prospective population-based study design. [ABSTRACT FROM AUTHOR]

Objective: Current health literacy measures are too long, imprecise, or have questionable equivalence of English and Spanish versions. The purpose of this paper is to describe the development and pilot testing of a new bilingual computer-based health literacy assessment tool.Methods: We analyzed literacy data from three large studies. Using a working definition of health literacy, we developed new prose, document and quantitative items in English and Spanish. Items were pilot tested on 97 English- and 134 Spanish-speaking participants to assess item difficulty.Results: Items covered topics relevant to primary care patients and providers. English- and Spanish-speaking participants understood the tasks involved in answering each type of question. The English Talking Touchscreen was easy to use and the English and Spanish items provided good coverage of the difficulty continuum.Conclusion: Qualitative and quantitative results provided useful information on computer acceptability and initial item difficulty. After the items have been administered on the Talking Touchscreen (la Pantalla Parlanchina) to 600 English-speaking (and 600 Spanish-speaking) primary care patients, we will develop a computer adaptive test.Practice Implications: This health literacy tool will enable clinicians and researchers to more precisely determine the level at which low health literacy adversely affects health and healthcare utilization. [ABSTRACT FROM AUTHOR]

Purpose. To compare the time to deterioration in health-related quality of life (HRQoL) in patients with previously untreated metastatic colorectal cancer receiving a 5-fluorouracil (5-FU)-based chemotherapy regimen with or without the addition of bevacizumab (BV) in two randomized, placebo-controlled studies.Patients and Methods. Prespecified HRQoL endpoints in the phase II (Study 2192) and phase III (Study 2107) studies were time to deterioration in HRQoL, measured by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Colorectal Cancer Subscale (CCS), Trial Outcome Index (TOI-C), and FACT-C total score. Time to deterioration in HRQoL was evaluated for patients with baseline and postbaseline assessments, using the stratified log-rank test.Results. In the pivotal phase III trial, HRQoL baseline and postbaseline CCS scores were available for 127 patients receiving irinotecan, 5-FU, and leucovorin (LV) (IFL) and 122 patients receiving IFL plus BV. The time to deterioration in HRQoL did not differ significantly between treatment groups as measured by the CCS, TOI-C, or FACT-C total score. In the phase II study, baseline and postbaseline CCS scores were available for 77 and 89 patients receiving 5-FU and LV and 5-FU and LV plus BV, respectively. In that study, the time to deterioration in HRQoL was similar between groups as measured by the CCS and TOI-C scores, but was significantly longer in the 5-FU and LV plus BV arm than in the 5-FU and LV plus placebo arm for the FACT-C total score.Conclusions. When added to 5-FU chemotherapy, BV significantly prolonged overall survival and progression-free survival without compromising HRQoL. [ABSTRACT FROM AUTHOR]

Endometrial cancer (EC) patients make up the second largest group of female cancer survivors. Patient-reported outcomes (PROs) including quality of life (QOL) and sexual function and satisfaction (SF and S) are critical facets of survivorship. This prospective, longitudinal study assesses associations between baseline characteristics and PROs after treatment. Herein, we report the baseline clinical characteristics and PROs prior to treatment initiation. Outcomes post-treatment over time will be reported separately. Patients with planned surgery for EC were prospectively enrolled in 2019-2021 and administered the European Organization for Research and Treatment of Cancer (EORTC) QOL Questionnaire Core 30 (QLQ-C30), EORTC QLQ EC Module (EN24), Patient-Reported Outcomes Measurement Information System (PROMIS), and the Mayo Clinic lower extremity lymphedema (LEL) questionnaire. This study enrolled 198 patients with a mean (SD) age of 63.6 (9.8) years and body mass index of 35.5 (8.3) kg/m 2 . No significant differences in the PROs for the QOL were seen when compared to the reference means (SD) except for the lower interest in sexual activity (31.9 (9.8) vs. 47.5 (SE0.70)) and lower fatigue (21.3 (19.8) vs. 31.7 (25.9)). Increased obesity was associated with an increased likelihood of LEL ( p < 0.01) and multiple QOL scales, including poorer global health status ( p < 0.01) and physical functioning ( p < 0.01). Prior to treatment initiation for EC, the patients had a similar QOL compared to that of the general population. The patients with increasing obesity, a known risk factor for EC, had worse overall global health status and physical functioning. A better understanding of these QOL measures is imperative for earlier identification and intervention of patients at risk of chronic impairments from EC treatment.

Objective: To identify the optimal incentive protocol for maximising participation while managing study costs during the Voyage trial., Design: Prospective cohort (Voyage trial) of colorectal cancer (CRC) incidence and mortality outcomes in individuals screened with multitarget stool DNA (mt-sDNA) served as the population. A subset was randomised to receive postage stamps as a pre-consent incentive, or as a post-consent incentive after completion of the consent and questionnaire. Descriptive statistics from year 1 are reported., Results: During year 1 of the Voyage trial, a total of 600 258 individuals with mt-sDNA orders received at Exact Sciences Laboratories were randomly selected and invited to participate. Of those, 26 429 (4.4%) opted in, 14 365 of whom (54.3%) consented. The opt-in and consent samples were similar to the target population with respect to sex but differed by geographic residence and age (p<0.001). For the embedded incentive experiment, 2333 were randomised to the pre-incentive arm, while 2342 were randomised to the post-incentive arm. Overall consent rate in the incentive trial was 56.4% (60.9% for the pre-consent incentive arm (1421/2333) vs 52.0% for the post-consent incentive arm (1217/2342), p<0.001). Cost reduction was observed for the pre-consent incentive group, and higher response rates were seen among older versus younger individuals., Conclusions: Pre-consent incentive option was associated with a higher participation rate and lower costs and was used for the remainder of study recruitment. CRC incidence and mortality vary with age; thus, adjusting for differential participation by age and region will be important in analyses of Voyage data., Trial Registration Number: NCT04124406., Competing Interests: Competing interests: KJY, REC, CRK, EJK, JLSS, JAG and JEO are employees of Mayo Clinic and received funding for this study through a grant from Exact Sciences Corporation. BK and JJL are employees and shareholders of Exact Sciences. At the start of the work herein, LJFR was an employee of the Mayo Clinic, whereby she offered scientific input to Exact Sciences for research studies through a contracted services agreement between Mayo Clinic and Exact Sciences Corporation. During the writing of this manuscript, she became a full-time employee of Exact Sciences Corporation. Currently, she is an employee of Mayo Clinic only., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Immediate lymphatic reconstruction (ILR) has been proposed to decrease lymphedema rates. The primary aim of our study was to determine whether ILR decreased the incidence of lymphedema in patients undergoing axillary lymph node dissection (ALND)., Methods: We conducted a two-site pragmatic study of ALND with or without ILR, employing surgeon-level cohort assignment, based on breast surgeons' preferred standard practice. Lymphedema was assessed by limb volume measurements, patient self-reporting, provider documentation, and International Classification of Diseases, Tenth Revision (ICD-10) codes., Results: Overall, 230 patients with breast cancer were enrolled; on an intention-to-treat basis, 99 underwent ALND and 131 underwent ALND with ILR. Of the 131 patients preoperatively planned for ILR, 115 (87.8%) underwent ILR; 72 (62.6%) were performed by one breast surgical oncologist and 43 (37.4%) by fellowship-trained microvascular plastic surgeons. ILR was associated with an increased risk of lymphedema when defined as ≥10% limb volume change on univariable analysis, but not on multivariable analysis, after propensity score adjustment. We did not find a statistically significant difference in limb volume measurements between the two cohorts when including subclinical lymphedema (≥5% inter-limb volume change), nor did we see a difference in grade between the two cohorts on an intent-to-treat or treatment received basis. For all patients, considering ascertainment strategies of patient self-reporting, provider documentation, and ICD-10 codes, as a single binary outcome measure, there was no significant difference in lymphedema rates between those undergoing ILR or not., Conclusion: We found no significant difference in lymphedema rates between patients undergoing ALND with or without ILR., (© 2024. Society of Surgical Oncology.)

Purpose: The Targeted Agent and Profiling Utilization Registry Study is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations known to be drug targets. Results of a cohort of patients with various solid tumors with germline or somatic BRCA1/2 mutations treated with talazoparib are reported., Methods: Eligible patients had advanced solid tumors, measurable disease (RECIST), Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and no standard treatment options. Patients with germline BRCA -mutated human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer were not eligible for this study. Primary end point was disease control (DC) determined by investigator assessment of objective response (OR) or stable disease (SD) of at least 16 weeks duration (SD16+). The results were evaluated on the basis of a one-sided exact binomial test with a null DC rate of 15% versus 35% (power = 0.82; α = .10). Secondary end points were OR, progression-free survival, overall survival, duration of response, duration of SD, and safety., Results: Twenty-eight patients (20 cancer types) with BRCA1/2 mutations were enrolled from December 2019 to September 2021 and collapsed into a single histology pooled cohort for analysis. All patients were evaluable for efficacy. One complete response, nine partial response, and six SD16+ were observed for DC and OR rates of 57% (one-sided 90% CI, 43 to 100) and 36% (95% CI, 19 to 56), respectively. The null hypothesis of a 15% DC rate was rejected ( P < .001). Patients with OR had the following tumor types: breast (2), nonmelanoma skin, mesothelioma, stomach, uterus, non-small cell lung cancer, ovary, hepatocellular carcinoma, and pancreas. Thirteen patients had at least one grade 3-5 adverse event (AE) or serious AE at least possibly related to talazoparib. All were consistent with the drug label except bilirubin increase and hyponatremia (both grade 3 AEs)., Conclusion: Talazoparib demonstrated antitumor activity in patients with advanced solid tumors and BRCA1/2 mutations, including cancer types for which poly ADP-ribose polymerase inhibitors are not yet US Food and Drug Administration-approved.

Importance: Patients with head and neck cancer who undergo radiotherapy can develop chronic radiation-induced xerostomia. Prior acupuncture studies were single center and rated as having high risk of bias, making it difficult to know the benefits of acupuncture for treating radiation-induced xerostomia., Objective: To compare true acupuncture (TA), sham acupuncture (SA), and standard oral hygiene (SOH) for treating radiation-induced xerostomia., Design, Setting, and Participants: A randomized, blinded, 3-arm, placebo-controlled trial was conducted between July 29, 2013, and June 9, 2021. Data analysis was performed from March 9, 2022, through May 17, 2023. Patients reporting grade 2 or 3 radiation-induced xerostomia 12 months or more postradiotherapy for head and neck cancer were recruited from community-based cancer centers across the US that were part of the Wake Forest National Cancer Institute Community Oncology Research Program Research Base. Participants had received bilateral radiotherapy with no history of xerostomia., Interventions: Participants received SOH and were randomized to TA, SA, or SOH only. Participants in the TA and SA cohorts were treated 2 times per week for 4 weeks. Those experiencing a minor response received another 4 weeks of treatment., Main Outcomes and Measures: Patient-reported outcomes for xerostomia (Xerostomia Questionnaire, primary outcome) and quality of life (Functional Assessment of Cancer Therapy-General) were collected at baseline, 4 (primary time point), 8, 12, and 26 weeks. All analyses were intention to treat., Results: A total of 258 patients (201 men [77.9%]; mean [SD] age, 65.0 [9.16] years), participated from 33 sites across 13 states. Overall, 86 patients were assigned to each study arm. Mean (SD) years from diagnosis was 4.21 (3.74) years, 67.1% (n = 173) had stage IV disease. At week 4, Xerostomia Questionnaire scores revealed significant between-group differences, with lower Xerostomia Questionnaire scores with TA vs SOH (TA: 50.6; SOH: 57.3; difference, -6.67; 95% CI, -11.08 to -2.27; P = .003), and differences between TA and SA (TA: 50.6; SA: 55.0; difference, -4.41; 95% CI, -8.62 to -0.19; P = .04) yet did not reach statistical significance after adjustment for multiple comparisons. There was no significant difference between SA and SOH. Group differences in Functional Assessment of Cancer Therapy-General scores revealed statistically significant group differences at week 4, with higher scores with TA vs SOH (TA: 101.6; SOH: 97.7; difference, 3.91; 95% CI, 1.43-6.38; P = .002) and at week 12, with higher scores with TA vs SA (TA: 102.1; SA: 98.4; difference, 3.64; 95% CI, 1.10-6.18; P = .005) and TA vs SOH (TA: 102.1; SOH: 97.4; difference, 4.61; 95% CI, 1.99-7.23; P = .001)., Conclusions and Relevance: The findings of this trial suggest that TA was more effective in treating chronic radiation-induced xerostomia 1 or more years after the end of radiotherapy than SA or SOH., Trial Registration: ClinicalTrials.gov Identifier: NCT02589938.

Background: The Upper Digestive Disease (UDD) Tool™ is used to monitor symptom frequency, intensity, and interference across nine symptom domains and includes two Patient-Reported Outcome Measurement Information System (PROMIS) domains assessing physical and mental health. This study aimed to establish cut scores for updated symptom domains through standard setting exercises and evaluate the effectiveness and acceptability of virtual standard setting., Methods: The extended Angoff method was employed to determine cut scores. Subject matter experts refined performance descriptions for symptom control categories and achieved consensus. Domains were categorized into good, moderate, and poor symptom control. Two cut scores were established, differentiating good vs. moderate and moderate vs. poor. Panelists estimated average scores for 100 borderline patients per item. Cut scores were computed based on the sum of the average ratings for individual questions, converted to 0-100 scale., Results: Performance descriptions were refined. Panelists discussed that interpretation of the scores should take into account the timing of symptoms after surgery and patient populations, and the importance of items asking symptom frequency, severity, and interference with daily life. The good/moderate cut scores ranged from 21.3 to 35.0 (mean 28.6, SD 3.6) across domains, and moderate/poor ranged from 47.5 to 71.3 (mean 54.5, SD 7.0)., Conclusions: Panelists were confident in the virtual standard setting process, expecting valid cut scores. Future studies can further validate the cut scores using patient perspectives and collect patient and physician preferences for displaying contextual items on patient- and physician-facing dashboard., (© 2024. The Author(s).)

Background: The aim of this study was to develop a web-based tool for patients with multiple chronic conditions (MCC) to communicate concerns about treatment burden to their healthcare providers., Methods: Patients and providers from primary-care clinics participated. We conducted focus groups to identify content for a prototype clinical tool to screen for treatment burden by reviewing domains and items from a previously validated measure, the Patient Experience with Treatment and Self-management (PETS). Following review of the prototype, a quasi-experimental pilot study determined acceptability of using the tool in clinical practice. The study protocol was modified to accommodate limitations due to the Covid-19 pandemic., Results: Fifteen patients with MCC and 18 providers participated in focus groups to review existing PETS content. The pilot tool (named PETS-Now) consisted of eight domains (Living Healthy, Health Costs, Monitoring Health, Medicine, Personal Relationships, Getting Healthcare, Health Information, and Medical Equipment) with each domain represented by a checklist of potential concerns. Administrative burden was minimized by limiting patients to selection of one domain. To test acceptability, 17 primary-care providers first saw 92 patients under standard care (control) conditions followed by another 90 patients using the PETS-Now tool (intervention). Each treatment burden domain was selected at least once by patients in the intervention. No significant differences were observed in overall care quality between patients in the control and intervention conditions with mean care quality rated high in both groups (9.3 and 9.2, respectively, out of 10). There were no differences in provider impressions of patient encounters under the two conditions with providers reporting that patient concerns were addressed in 95% of the visits in both conditions. Most intervention group patients (94%) found that the PETS-Now was easy to use and helped focus the conversation with the provider on their biggest concern (98%). Most providers (81%) felt they had learned something new about the patient from the PETS-Now., Conclusion: The PETS-Now holds promise for quickly screening and monitoring treatment burden in people with MCC and may provide information for care planning. While acceptable to patients and clinicians, integration of information into the electronic medical record should be prioritized., (© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

To address the current and long-term unmet health needs of the growing population of non-Hodgkin lymphoma (NHL) patients, we established the Lymphoma Epidemiology of Outcomes (LEO) cohort study (NCT02736357; https://leocohort.org/). A total of 7735 newly diagnosed patients aged 18 years and older with NHL were prospectively enrolled from 7/1/2015 to 5/31/2020 at 8 academic centers in the United States. The median age at diagnosis was 62 years (range, 18-99). Participants came from 49 US states and included 538 Black/African-Americans (AA), 822 Hispanics (regardless of race), 3386 women, 716 age <40 years, and 1513 rural residents. At study baseline, we abstracted clinical, pathology, and treatment data; banked serum/plasma (N = 5883, 76.0%) and germline DNA (N = 5465, 70.7%); constructed tissue microarrays for four major NHL subtypes (N = 1189); and collected quality of life (N = 5281, 68.3%) and epidemiologic risk factor (N = 4489, 58.0%) data. Through August 2022, there were 1492 deaths. Compared to population-based SEER data (2015-2019), LEO participants had a similar distribution of gender, AA race, Hispanic ethnicity, and NHL subtype, while LEO was underrepresented for patients who were Asian and aged 80 years and above. Observed overall survival rates for LEO at 1 and 2 years were similar to population-based SEER rates for indolent B-cell (follicular and marginal zone) and T-cell lymphomas, but were 10%-15% higher than SEER rates for aggressive B-cell subtypes (diffuse large B-cell and mantle cell). The LEO cohort is a robust and comprehensive national resource to address the role of clinical, tumor, host genetic, epidemiologic, and other biologic factors in NHL prognosis and survivorship., (© 2024 Wiley Periodicals LLC.)

Introduction/objective: Physicians and other health care professionals are challenged regularly to balance managing pain for patients with chronic pain receiving chronic opioid therapy (COT) with following the national guidelines and standards regarding daily morphine milligram equivalents (MME). This quality improvement project aimed to determine the effect of referral to a multidisciplinary review panel on daily MME for patients receiving COT for chronic pain., Methods: This quality improvement project included patients who had an established relationship with a primary care or community internal medicine clinician at a large health care organization and were referred to a newly created multidisciplinary review panel for their recommendations regarding treatment of pain. Criteria for patient referral were diagnosis of a chronic, painful condition, and use of chronic opioid medications. These patients were selected and referred at the discretion of their primary care clinician from January 2, 2019, through December 31, 2020. Data for this project were collected at the time of initial referral to the panel and 6 months after recommendations. The daily MME were assessed at the 2 time points., Results: Thirteen patients were referred to the review panel during the project period. The median daily MME at the time of referral was 180. Daily MME decreased by a median of 14 MME after 6 months. The MME did not increase during the project period for any participants., Conclusions: Referral of patients receiving COT to a multidisciplinary review panel may reduce their daily opioid dose., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Primary hypoadrenocorticism in dogs is thought to be multifactorial with roles for both genetic and environmental factors. The contributions of environmental factors remain unexplored., Objective: Identify environmental and lifestyle exposures associated with primary hypoadrenocorticism in 2 dog breeds with high risk of developing the disease., Animals: Animals were not used in this study. Owners of Standard Poodles (STPDs) and Portuguese water dogs (POWDs) participated in a survey., Methods: Retrospective case-control study. Dog owners were invited to participate in an online survey through convenience sampling. Questions regarded the demographics, health histories, and indoor/outdoor environments in which their dogs live and play. Responses for dogs with primary hypoadrenocorticism were compared to those without the disease using univariate and multivariate logistic regression models., Results: Five thousand forty-seven responses (358 cases, 4689 controls) met initial inclusion criteria. Significant associations with modest effect size were found for community type, ingestion of canned food, and use of lawn fertilizer in some analysis models. Reproductive (spay/neuter) status exhibited the strongest association with high effect size across all models with adjusted odds ratio (OR) 2.5 (95% confidence interval [CI], 1.4-4.5; P = .003) for spayed females and 6.0 (95% CI, 2.6-13.9; P < .001) for neutered males., Conclusions and Clinical Importance: The large effect size for reproductive status reflects its high potential clinical relevance, whereas modest effect sizes for other environmental variables suggest lower potential clinical relevance. These findings are associations and do not necessarily imply causation. Before any actionable recommendations are warranted, additional evidence regarding biological mechanisms is needed., (© 2023 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals LLC on behalf of American College of Veterinary Internal Medicine.)

Background: Somali immigrants and refugees constitute one of the largest African ethnic groups immigrating to the United States over the past three decades with the majority resettling in the state of Minnesota. Previous studies have documented significant cancer screening disparities between the Somali population and the general population. However, little is known about cancer incidence among Somali groups living in the United States., Methods: We determined the incidence of 18 types or sites of malignancy using ICD-9 and ICD-10 codes and compared them between Somali and non-Somali populations in Olmsted County, Minnesota utilizing the Rochester Epidemiology Project medical records-linkage infrastructure for the years 2000-2020. Poisson regression models were used to model the rates for each malignancy., Results: There was a higher incidence and relative risk of liver malignancies among the Somali population versus non-Somali population, but lower relative risk and incidence of the following malignancies: breast, cervical, and melanoma. After direct age-sex adjustment to the United States 2000 Census population, liver was the most common cancer in Somali men, while breast cancer was the most common malignancy in women., Conclusion: Malignancies related to infectious agents such as viral hepatitis have a higher incidence in the Somali immigrant population of Olmsted County. There is a lower incidence of malignancies related to lifestyle factors in this Somali population. Findings of this study may help inform cancer prevention and screening strategies among Somali communities in the United States., (© 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Objective: To compare patient-reported outcomes before and after implementation of evidence-based, procedure-specific opioid prescribing guidelines., Background: The opioid epidemic remains a significant public health issue. Many institutions have responded by reducing opioid prescribing after surgery. However, the impact of this on patient-reported outcomes remains poorly understood., Methods: Opioid-naïve adults undergoing 12 elective general surgery procedures at a single institution prospectively completed telephone surveys at median 26 days from discharge. Patients were compared before (March 2017-January 2018) and after (May 2019-November 2019) implementation of evidence-based, procedure-specific opioid prescribing guidelines., Results: A total of 603 preguideline and 138 postguideline patients met inclusion criteria and completed surveys. Overall, 60.5% of preguideline and 92.5% of postguideline prescriptions fell within recommendations ( P <0.001), while refill rates were similar (4.5% vs 5.8%, P =0.50). A statistically significant drop in median morphine milligram equivalent prescribed was observed for 9 of 12 procedures (75%). No opioids were prescribed for 16.7% of patients in both cohorts ( P =0.98). While 93.3% of preguideline and 87.7% of postguideline patients were very/somewhat satisfied with their pain control, the proportion of patients who were very/somewhat dissatisfied increased from 4.2% to 9.4% ( P =0.039)., Conclusions: Prescribing guidelines successfully reduced opioid prescribing without increased refill rates. Despite decreased prescribing overall, there was a continued reluctance to prescribe no opioids after surgery. Although most patients experienced good pain control, there remains a subset of patients whose pain is not optimally managed in the era of reduced opioid prescribing., Competing Interests: The authors report no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The objective of this study was to assess the criterion validity of score thresholds for the Upper Digestive Disease (UDD) App., Methods: From December 15, 2017, to December 15, 2020, patients presenting after esophagectomy were offered the UDD App concurrent with a provider visit. This tool consists of 67 questions including 5 novel domains. Score thresholds were used to assign patients to a good, moderate, or poor category on the basis of domain scores. Providers were given performance descriptions for each domain and asked to assign patients to a category on the basis of their clinical evaluation. The weighted κ statistic was used to determine the magnitude of agreement between classifications based on the patients' UDD App scores and the providers' clinical evaluation., Results: Fifty-nine patients in the study (76% male; median age, 63 years [interquartile range, 57-72 years]) reported outcomes using the UDD App. Providers reviewed between 1 and 10 patients at a median time of 296.5 days (interquartile range, 50-975 days) after esophagectomy. The magnitude of agreement between patients and providers was moderate for dysphagia (κ = 0.52; P < .001) and reflux (κ = 0.42; P < .001). Dumping-related hypoglycemia (κ = 0.03; P = .148), gastrointestinal complaints (κ = 0.02; P = .256), and pain (κ = 0.05; P < .184) showed minimal agreement, with providers underestimating the symptoms and problems reported by patients in these domains., Conclusions: Although there was agreement between UDD App assessment and provider evaluation of dysphagia and reflux after esophagectomy, there was discordance of scoring for dumping-related symptoms and pain. Future research is needed to determine whether thresholds for pain and dumping domains need to be revised or whether additional provider education on performance descriptions is needed., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: This study compares classical test theory and item response theory frameworks to determine reliable change. Reliable change followed by anchoring to the change in categorically distinct responses on a criterion measure is a useful method to detect meaningful change on a target measure., Methods: Adult cancer patients were recruited from five cancer centers. Baseline and follow-up assessments at 6 weeks were administered. We investigated short forms derived from PROMIS® item banks on anxiety, depression, fatigue, pain intensity, pain interference, and sleep disturbance. We detected reliable change using reliable change index (RCI). We derived the T-scores corresponding to the RCI calculated under IRT and CTT frameworks using PROMIS® short forms. For changes that were reliable, meaningful change was identified using patient-reported change in PRO-CTCAE by at least one level. For both CTT and IRT approaches, we applied one-sided tests to detect reliable improvement or worsening using RCI. We compared the percentages of patients with reliable change and reliable/meaningful change., Results: The amount of change in T score corresponding to RCI CTT of 1.65 ranged from 5.1 to 9.2 depending on domains. The amount of change corresponding to RCI IRT of 1.65 varied across the score range, and the minimum change ranged from 3.0 to 8.2 depending on domains. Across domains, the RCI CTT and RCI IRT classified 80% to 98% of the patients consistently. When there was disagreement, the RCI IRT tended to identify more patients as having reliably changed compared to RCI CTT if scores at both timepoints were in the range of 43 to 78 in anxiety, 45 to 70 in depression, 38 to 80 in fatigue, 35 to 78 in sleep disturbance, and 48 to 74 in pain interference, due to smaller standard errors in these ranges using the IRT method. The CTT method found more changes compared to IRT for the pain intensity domain that was shorter in length. Using RCI CTT , 22% to 66% had reliable change in either direction depending on domains, and among these patients, 62% to 83% had meaningful change. Using RCI IRT , 37% to 68% had reliable change in either direction, and among these patients, 62% to 81% had meaningful change., Conclusion: Applying the two-step criteria demonstrated in this study, we determined how much change is needed to declare reliable change at different levels of baseline scores. We offer reference values for percentage of patients who meaningfully change for investigators using the PROMIS instruments in oncology., (© 2022. The Author(s).)

Esophageal cancer (EC) patients are living longer due to enhanced screening and novel therapeutics, however, the post-esophagectomy long-term management remains challenging for patients, caregivers, and providers. Patients experience significant morbidity and have difficulty managing symptoms. Providers struggle to manage symptoms, affecting patients' quality of life and complicating care coordination between surgical teams and primary care providers. To address these patient unique needs and create a standardized method for evaluating patient reported long-term outcomes after esophagectomy for EC, our team developed the Upper Digestive Disease Assessment tool, which evolved to become a mobile application. This mobile application is designed to monitor symptom burden, direct assessment, and quantify data for patient outcome analysis after foregut (upper digestive) surgery, including esophagectomy. It is available to the public and enables virtual and remote access to survivorship care. Patients using the Upper Digestive Disease Application (UDD App) must consent to enroll, agree to terms of use, and acknowledge use of health-related information prior to gaining access to the UDD App. The results of patients scores can be utilized for triage and assessment. Care pathways can guide management of severe symptoms in a scalable and standardized method. Here we describe the history, process, and methodology for developing a patient-centric remote monitoring program to improve survivorship after EC. Programs like this that facilitate patient-centered survivorship should be an integral part of comprehensive cancer patient care., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-22-1343/coif). SHB has a patent for an anastomotic esophageal stent. She has a clinical trial on lung ablation funded by Medtronic and a clinical trial on cryo ablation mesothelioma funded by Steris. She has been compensated as a consultant for Medtronic. She has released all profit from the UDD AppTM. LLC serves as a committee member in the Society of Critical Care Medicine PADIS Guidelines and the American Thoracic Society Planning and Evaluation. The other authors have no conflicts of interest to declare., (2023 Journal of Thoracic Disease. All rights reserved.)

Background: Whether pembrolizumab given both before surgery (neoadjuvant therapy) and after surgery (adjuvant therapy), as compared with pembrolizumab given as adjuvant therapy alone, would increase event-free survival among patients with resectable stage III or IV melanoma is unknown., Methods: In a phase 2 trial, we randomly assigned patients with clinically detectable, measurable stage IIIB to IVC melanoma that was amenable to surgical resection to three doses of neoadjuvant pembrolizumab, surgery, and 15 doses of adjuvant pembrolizumab (neoadjuvant-adjuvant group) or to surgery followed by pembrolizumab (200 mg intravenously every 3 weeks for a total of 18 doses) for approximately 1 year or until disease recurred or unacceptable toxic effects developed (adjuvant-only group). The primary end point was event-free survival in the intention-to-treat population. Events were defined as disease progression or toxic effects that precluded surgery; the inability to resect all gross disease; disease progression, surgical complications, or toxic effects of treatment that precluded the initiation of adjuvant therapy within 84 days after surgery; recurrence of melanoma after surgery; or death from any cause. Safety was also evaluated., Results: At a median follow-up of 14.7 months, the neoadjuvant-adjuvant group (154 patients) had significantly longer event-free survival than the adjuvant-only group (159 patients) (P = 0.004 by the log-rank test). In a landmark analysis, event-free survival at 2 years was 72% (95% confidence interval [CI], 64 to 80) in the neoadjuvant-adjuvant group and 49% (95% CI, 41 to 59) in the adjuvant-only group. The percentage of patients with treatment-related adverse events of grades 3 or higher during therapy was 12% in the neoadjuvant-adjuvant group and 14% in the adjuvant-only group., Conclusions: Among patients with resectable stage III or IV melanoma, event-free survival was significantly longer among those who received pembrolizumab both before and after surgery than among those who received adjuvant pembrolizumab alone. No new toxic effects were identified. (Funded by the National Cancer Institute and Merck Sharp and Dohme; S1801 ClinicalTrials.gov number, NCT03698019.)., (Copyright © 2023 Massachusetts Medical Society.)

Objective: To estimate rates and identify factors associated with asymptomatic COVID-19 in the population of Olmsted County during the prevaccination era., Patients and Methods: We screened first responders (n=191) and Olmsted County employees (n=564) for antibodies to SARS-CoV-2 from November 1, 2020 to February 28, 2021 to estimate seroprevalence and asymptomatic infection. Second, we retrieved all polymerase chain reaction (PCR)-confirmed COVID-19 diagnoses in Olmsted County from March 2020 through January 2021, abstracted symptom information, estimated rates of asymptomatic infection and examined related factors., Results: Twenty (10.5%; 95% CI, 6.9%-15.6%) first responders and 38 (6.7%; 95% CI, 5.0%-9.1%) county employees had positive antibodies; an additional 5 (2.6%) and 10 (1.8%) had prior positive PCR tests per self-report or medical record, but no antibodies detected. Of persons with symptom information, 4 of 20 (20%; 95% CI, 3.0%-37.0%) first responders and 10 of 39 (26%; 95% CI, 12.6%-40.0%) county employees were asymptomatic. Of 6020 positive PCR tests in Olmsted County with symptom information between March 1, 2020, and January 31, 2021, 6% (n=385; 95% CI, 5.8%-7.1%) were asymptomatic. Factors associated with asymptomatic disease included age (0-18 years [odds ratio {OR}, 2.3; 95% CI, 1.7-3.1] and >65 years [OR, 1.40; 95% CI, 1.0-2.0] compared with ages 19-44 years), body mass index (overweight [OR, 0.58; 95% CI, 0.44-0.77] or obese [OR, 0.48; 95% CI, 0.57-0.62] compared with normal or underweight) and tests after November 20, 2020 ([OR, 1.35; 95% CI, 1.13-1.71] compared with prior dates)., Conclusion: Asymptomatic rates in Olmsted County before COVID-19 vaccine rollout ranged from 6% to 25%, and younger age, normal weight, and later tests dates were associated with asymptomatic infection., (© 2022 The Authors.)

Purpose: TAPUR is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations known to be drug targets. The results of a cohort of patients with colorectal cancer (CRC) with BRAF mutations treated with cobimetinib (C) plus vemurafenib (V) are reported., Methods: Eligible patients had advanced CRC, no standard treatment options, measurable disease (RECIST), Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, tumors with BRAF V600E/D/K/R mutations, and no MAP2K1/2 , MEK1/2 , or NRAS mutations. C was taken 60 mg orally once daily for 21 days followed by seven days off, and V was taken 960 mg orally twice daily. Simon's two-stage design was used with a primary study end point of objective response or stable disease of at least 16 weeks duration. Secondary end points were progression-free survival, overall survival, and safety., Results: Thirty patients were enrolled from August 2016 to August 2018; all had CRC with a BRAF V600E mutation except one patient with a BRAF K601E mutation. Three patients were not evaluable for efficacy. Eight patients with partial responses and six patients with stable disease of at least 16 weeks duration were observed for disease control and objective response rates of 52% (95% CI, 35 to 65) and 30% (95% CI, 14 to 50), respectively. The null hypothesis of 15% disease control rate was rejected ( P < .0001). Thirteen patients had at least one grade 3 adverse event or serious adverse event at least possibly related to C + V: anemia, decreased lymphocytes, dyspnea, diarrhea, elevated liver enzymes, fatigue, hypercalcemia, hypophosphatemia, rash, photosensitivity, and upper gastrointestinal hemorrhage., Conclusion: The combination of C + V has antitumor activity in heavily pretreated patients with CRC with BRAF mutations.

Objective: To determine the relationship between characteristics of employment and future hospitalization in older adults., Patients and Methods: We conducted a survey of adults aged 65 years or older participating in the Mayo Clinic Biobank. Using a frequency-matched, case-control design, we compared patients who were hospitalized within 5 years of biobank enrollment (cases) with those who were not hospitalized (controls). We assessed the duration of work, age at first job, number of jobs, disability, retirement, and reasons for leaving work. We performed logistic regression analysis to assess the association of these factors with hospitalization, accounting for age, sex, comorbid conditions, and education level., Results: Among 3536 participants (1600 cases and 1936 controls; median age, 68.5 years; interquartile range, 63.4-73.9 years), cases were older, more likely to be male, and had lower education levels. Comorbid illnesses had the largest association with hospitalization (odds ratio [OR], 4.09; 95% CI, 3.37-4.97 [highest vs lowest quartile]). On adjusted analyses, odds of hospitalization increased with the presence of disability (OR, 1.31; 95% CI, 1.01-1.69) and decreased with having 1 or 2 lifetime jobs vs no employment (OR, 0.77; 95% CI, 0.60-1.00). The length of work, furlough, age of retirement, childcare issues, and reasons for leaving a job were not associated with hospitalization., Conclusion: This study reports an association between disability during work and hospitalization. On the basis of our findings, it may be important to obtain a more detailed work history from patients because it may provide further insight into their future health., (© 2022 The Authors.)

Background: Patient-reported outcomes (PROs) can enable communication of symptoms, function, and quality of life. Mobile devices capture PROs electronically (ePRO). The purpose of this study was to determine the feasibility and acceptability of collecting ePROs in esophagectomy patients using the upper digestive disease application (UDD App)., Methods: A single-group, mixed methods design was used to address the study purposes. A convenience sample of esophagectomy patients was recruited after resumption of an oral diet from January 2020 to December 2020. Demographic characteristics (age, sex) and clinical data (surgical procedure) were obtained after informed consent. Participants used the UDD App for 1 year, followed by scripted telephone interviews. Descriptive statistics and thematic analyses of the interviews were the primary data analyses., Results: Sixty-four patients were enrolled (80% male; 62.9 ± 12 years old). Of these, 50 patients initiated 108 evaluations through the UDD app, with 98% completing the questionnaire on the first attempt, indicating feasibility. A subset of 32 patients participated in the scripted telephone interview. Participants (74%) reported high computer literacy; all reported that using the UDD App was easier than or equivalent to a paper form. Interview themes revealed value of the app for identifying problems and enhanced communication with providers and caregivers, with an overall appreciation for the convenience of remote monitoring but concerns about data privacy., Conclusions: The UDD App is feasible and acceptable for collecting ePROs in esophagectomy patients. Future work will determine whether the UDD App improves symptoms, function, and quality of life., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Limited health literacy (HL) is associated with decreased kidney function and death in patients with chronic kidney disease. Less is known about the impact of HL on kidney transplant (KT) outcomes. The aim of this study was to examine the relationship between HL and KT outcomes, including rates of waitlisting, healthcare utilization, acute rejection, renal allograft function, renal allograft failure, and death., Methods: We performed a retrospective review of HL data previously collected at our center. HL was assessed in a convenience sample of consecutive, English-speaking patients age ≥18 y who were evaluated for KT at Mayo Clinic in Minnesota between June 2015 and March 2017 as part of a practice improvement feasibility project (n = 690). HL was assessed using the 4-item Brief Health Literacy Screening Tool modified for the outpatient KT evaluation process. The 4 items assess confidence completing forms, reading comprehension, and oral literacy., Results: Overall, 30.4% of patients had limited or marginal HL. Patients with limited or marginal HL were less likely than those with adequate HL to be waitlisted for KT (hazard ratio = 0.62 and 0.69, respectively), even after adjusting for age, marital status, body mass index, Charlson comorbidity index, or dialysis dependency. Patient HL was not associated with post-KT healthcare utilization, acute rejection, or renal allograft function. Patients with limited or marginal HL appeared to experience a higher risk of renal allograft failure and post-KT death, but the number of events was small, and the relationship was statistically significant only for marginal HL., Conclusions: Inadequate HL is common in KT candidates and independently associated with decreased waitlisting for KT. We observed no statistically significant relationship between HL and posttransplant outcomes in our cohort. Further efforts to improve communication in patients with inadequate HL may improve access to KT., Competing Interests: W.K.K. has received research funding from AstraZeneca, Roche, and Biogen. The other authors declare no conflicts of interest., (Copyright © 2022 The Author(s). Transplantation Direct. Published by Wolters Kluwer Health, Inc.)

Background: Treatment burden refers to the work involved in managing one's health and its impact on well-being and has been associated with nonadherence in patients with chronic illnesses. No kidney transplant (KT)-specific measure of treatment burden exists. The aim of this study was to develop a KT-specific supplement to the Patient Experience with Treatment and Self-Management (PETS), a general measure of treatment burden., Methods: After drafting and pretesting KT-specific survey items, we conducted a cross-sectional survey study involving KT recipients from Mayo Clinic in Minnesota, Arizona, and Florida. Exploratory factor analysis (EFA) was used to identify domains for scaling the KT-specific supplement. Construct and known-groups validity were determined., Results: Survey respondents (n = 167) had a mean age of 61 years (range 22-86) and received a KT on average 4.0 years ago. Three KT-specific scales were identified (transplant function, self-management, adverse effects). Higher scores on the KT-specific scales were correlated with higher PETS treatment burden, worse physical and mental health, and lower self-efficacy (p < 0.0001). Patients taking more medications reported higher transplant self-management burden., Conclusions: We developed a KT-specific supplement to the PETS general measure of treatment burden. Scores may help providers identify recipients at risk for nonadherence., (© 2022. The Author(s).)

Objective: Facial nerve function, hearing preservation, and tumor control have been the primary benchmarks used to assess vestibular schwannoma (VS) outcomes. Acknowledging the frequent discrepancy between what physicians prioritize and what patients value, there has been increasing prioritization of patient-reported outcome measures when evaluating the impact of VS diagnosis and its treatment. Motivated by reported limitations of prior instruments used to assess quality of life (QOL) in patients with VS, the authors describe the development and validation of a new disease-specific QOL measure: the Vestibular Schwannoma Quality of Life (VSQOL) Index., Methods: The content development phase comprised identification of clinically important domains and prioritization of feelings or concerns individuals with VS may have. The validation phase encompassed determining how items were grouped into domains and eliminating redundant items. Both phases leveraged data from cross-sectional and longitudinal surveys, expertise from a multidisciplinary working group, and patients with a broad range of experiences with VS (n = 42 during content development and n = 263 during validation). Domain scores from the new instrument were assessed for reliability and correlation with other measures of similar constructs., Results: The VSQOL Index consists of 40 items that evaluate the impact of VS diagnosis and its management on QOL, treatment satisfaction, and employment and is estimated to take 8-10 minutes to complete. Domain scores range from 0 (worst) to 100 (best) and demonstrate excellent psychometric properties, including content, construct, and convergent validity and both internal consistency (Cronbach's alphas 0.83 to 0.91) and test-retest reliability (reliability coefficients 0.86 to 0.96)., Conclusions: The VSQOL Index is a valid and reliable measure that overcomes several limitations of prior instruments, including omission or underrepresentation of domains that frequently impact well-being, such as pain, cognition, satisfaction or regret surrounding treatment decisions, and occupational limitations, to comprehensively evaluate the impact of VS diagnosis or its treatment on QOL.

Purpose: Use of the electronic health record (EHR) during face-to-face clinical encounters affects communication, and prior research has been inconclusive regarding its effect. This survey study assessed health care practitioner use of EHR-specific communication skills and patient and practitioner experiences and attitudes regarding EHR use during clinical encounters., Methods: For this US-based study, we distributed previously validated surveys to practitioners and adult patients (aged >18 years) at academic primary care practices from July 1, 2018 through August 31, 2018. The electronic practitioner survey was completed first; a paper survey was administered to patients after appointments. Descriptive statistics were calculated, and the Cochran-Armitage test was used to assess for associations between key variables., Results: The practitioner response was 72.9% (43/59); patient response, 45.2% (452/1,000). Practitioners reported maintaining less eye contact (79.1%), listening less carefully (53.5%), focusing less on patients (65.1%), and visits feeling less personal (62.8%). However, patients reported that practitioners provided sufficient eye contact (96.8%) and listened carefully (97.0%); they disagreed that practitioners focused less on them (86.7%) or that visits felt less personal (87.2%). Patients thought EHR use was positive (91.7%); only one-third of practitioners (37.2%) thought that patients would agree with that statement. Practitioners reported stress, burnout, and a lack of sufficient time for EHR documentation., Conclusions: A discrepancy existed in this study between patient and practitioner experiences and attitudes about EHR use, which appeared to negatively affect the experience of health care practitioners but not patients. Organizations should adopt formal strategies to improve practitioner experiences with EHR use., (© 2022 Annals of Family Medicine, Inc.)

Purpose: This study assessed the long-term quality of life (QOL) of patients with aggressive lymphoma subtypes treated with autologous hematopoietic cell transplant (autoHCT) compared with those without history of transplant., Methods: Patient-reported QOL measures were prospectively gathered from patients enrolled in the Iowa/Mayo Specialized Program of Research Excellence Molecular Epidemiology Resource cohort with aggressive lymphoma subtypes. QOL was measured using the Functional Assessment of Cancer Therapy-General (FACT-G), Functional Assessment of Chronic Illness Therapy-Fatigue Scale, State-Trait Anxiety Inventory (STAI), and Profile of Mood States instruments and with a numeric rating scale for overall QOL and spiritual QOL. The autoHCT group and no HCT groups were compared at 3 years (FU3) and 6 years (FU6) after lymphoma diagnosis., Results: In total, 980 patients with lymphoma (106 autoHCT and 874 no HCT) diagnosed between 2002 and 2013 were included for analysis. The mean FACT-G total score was similar in the autoHCT and no HCT groups at FU3 (89.9 v 90.1, P = .64) and also at FU6 (91.5 v 89.6, P = .44). No differences between the autoHCT and no HCT groups were identified in the FACT subscales. The STAI identified lower anxiety in the autoHCT group by mean STAI1 (state) at FU3 (30.1 v 33.4, P < .01) and by mean STAI2 (trait) at FU6 (30.1 v 33.5, P = .02). No other clinically meaningful differences were identified between the two groups using the other QOL instruments., Conclusion: Patients remaining in remission at 3 and 6 years after diagnosis had a high level of QOL with no significant differences associated with history of treatment with autoHCT.

Background: In clinical trials and clinical practice, patient-reported outcomes are almost always assessed using multiple patient-reported outcome measures at the same time. This raises concerns about whether patient responses are affected by the order in which the patient-reported outcome measures are administered., Methods: This questionnaire-based study of order effects included adult cancer patients from five cancer centers. Patients were randomly assigned to complete questionnaires via paper booklets, interactive voice response system, or tablet web survey. Linear Analogue Self-Assessment, Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, and Patient-Reported Outcomes Measurement Information System assessment tools were each used to measure general health, physical function, social function, emotional distress/anxiety, emotional distress/depression, fatigue, sleep, and pain. The order in which the three tools, and domains within tools, were presented to patients was randomized. Rates of missing data, scale scores, and Cronbach's alpha coefficients were compared by the order in which they were assessed. Analyses included Cochran-Armitage trend tests and mixed models adjusted for performance score, age, sex, cancer type, and curative intent., Results: A total of 1830 patients provided baseline patient-reported outcome assessments. There were no significant trends in rates of missing values by whether a scale was assessed earlier or later. The largest order effect for scale scores was due to a large mean score at one assessment time point. The largest difference in Cronbach's alpha between the versions for the Patient-Reported Outcomes Measurement Information System scales was 0.106., Conclusion: The well-being of a cancer patient has many different aspects such as pain, fatigue, depression, and anxiety. These are assessed using a variety of surveys often collected at the same time. This study shows that the order in which the different aspects are collected from the patient is not important.

Background: The development of major low anterior resection syndrome (LARS) after low anterior resection is severely detrimental to quality of life, yet awareness of it by clinicians and patients and the frequency of treatment of LARS is unclear., Study Design: Patients who underwent low anterior resection for sigmoid or rectal cancer at a tertiary center between 2007 and 2017 (n = 798) were surveyed in 2019 to assess LARS symptoms and report medications or treatment received for LARS. LARS scores were calculated (score range 0-42) and normalized to published data on LARS prevalence in the general population in Europe, stratified by age (<50 or ≥50) and sex., Results: Of the 594 patients (74%) who returned the survey, 255 (43%) were identified as having major LARS (LARS score ≥30). This prevalence was significantly higher than published normative data from Denmark and Amsterdam when stratified by age greater than or less than 50 and sex. Patients with major LARS infrequently reported current use of first-line therapies (antidiarrheal medications 32%, fiber supplements 16%, and both 13%). Only 3% reported receiving second-line therapy of transanal irrigations and/or pelvic floor rehabilitation, and only 1% had undergone third-line therapy of sacral nerve stimulator implantation., Conclusion: Major LARS is common yet seemingly underrecognized by clinicians because less than half of patients are on first-line therapy and practically none are on second- and third-line therapies. Long-term follow-up of patients after low anterior resection, improved preoperative and postoperative education, and continued symptom assessment is necessary to improve treatment of major LARS., (Copyright © 2022 by the American College of Surgeons. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Purpose: To determine the effectiveness of a shared decision-making (SDM) tool versus guideline-informed usual care in translating evidence into primary care, and to explore how use of the tool changed patient perspectives about diabetes medication decision making., Methods: In this mixed methods multicenter cluster randomized trial, we included patients with type 2 diabetes mellitus and their primary care clinicians. We compared usual care with or without a within-encounter SDM conversation aid. We assessed participant-reported decisions made and quality of SDM (knowledge, satisfaction, and decisional conflict), clinical outcomes, adherence, and observer-based patient involvement in decision-making (OPTION12-scale). We used semi-structured interviews with patients to understand their perspectives., Results: We enrolled 350 patients and 99 clinicians from 20 practices and interviewed 26 patients. Use of the conversation aid increased post-encounter patient knowledge (correct answers, 52% vs. 45%, p = 0.02) and clinician involvement of patients (Mean between-arm difference in OPTION12, 7.3 (95% CI 3, 12); p = 0.003). There were no between-arm differences in treatment choice, patient or clinician satisfaction, encounter length, medication adherence, or glycemic control. Qualitative analyses highlighted differences in how clinicians involved patients in decision making, with intervention patients noting how clinicians guided them through conversations using factors important to them., Conclusions: Using an SDM conversation aid improved patient knowledge and involvement in SDM without impacting treatment choice, encounter length, medication adherence or improved diabetes control in patients with type 2 diabetes. Future interventions may need to focus specifically on patients with signs of poor treatment fit., Clinical Trial Registration: ClinicalTrial.gov: NCT01502891., (© 2021. The Author(s).)

Background: The pattern of perioperative use of personal electronic devices (PEDs) among anesthesia providers in the United States is unknown., Methods: We developed a 31-question anonymous survey of perioperative PED use that was sent to 813 anesthesiologists, anesthesiology residents, and certified registered nurse anesthetists at 3 sites within one health system. The electronic survey assessed patterns of PED use inside the operating room (OR), outside the OR, and observed in others. Questions were designed to explore the various purposes for PED use, the potential impact of specific hospital policies or awareness of medicolegal risk on PED use, and whether PED was a source of perioperative distraction., Results: The overall survey response rate was 36.8% (n = 299). With regard to often/frequent PED activity inside the OR, 24% reported texting, 5% reported talking on the phone, and 11% reported browsing on the Internet. With regard to often/frequent PED activity outside the OR, 88% reported texting, 26% reported talking on the phone, and 63% reported browsing the Internet. With regard to often/frequent PED activity observed in others, 52% reported others texting, 14% reported others talking on the phone, and 34% reported others browsing the Internet. Two percent of respondents self-reported a distraction compared to 15% who had observed a distraction in others. Eighty percent of respondents recognized PED as a potential distraction for patient safety., Conclusions: Our data reinforce that PED use is prevalent among anesthesia providers., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2021 International Anesthesia Research Society.)

Background: Cutaneous melanoma is strongly associated with tanning bed use., Objective: To describe local residents' knowledge, attitudes, and behavior regarding skin cancer and tanning bed use and to estimate prevalence of high risk for melanoma., Materials and Methods: A survey was mailed to 886 local residents (549, aged 18-39 years; 337, aged ≥40 years). Logistic and linear regression and univariate and multivariable analysis were used to assess perceived risk and skin cancer knowledge., Results: The response rate was 21%; 55% of the younger group and 37% of the older group had used indoor tanning, and prevalence of high risk for melanoma according to a skin cancer risk calculator was 18% in the younger group and 33% in the older group. Individuals with high risk scores were more likely to correctly perceive that they were at high risk for skin cancer. Most participants with high risk scores and those who previously used tanning beds reported low likelihood of future indoor tanning., Conclusion: Female sex, high risk score, and previous indoor tanning were associated with participants' views of higher skin cancer risk. No specific knowledge gaps were identified. Understanding community residents' attitudes about skin cancer and indoor tanning can help guide interventions., (Copyright © 2021 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: The study tests the effects of data collection modes on patient responses associated with the multi-item measures such as Patient-Reported Outcomes Measurement System (PROMIS ® ), and single-item measures such as Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and Numerical Rating Scale (NRS) measures., Methods: Adult cancer patients were recruited from five cancer centers and administered measures of anxiety, depression, fatigue, sleep disturbance, pain intensity, pain interference, ability to participate in social roles and activities, global mental and physical health, and physical function. Patients were randomized to complete the measures on paper (595), interactive voice response (IVR, 596) system, or tablet computer (589). We evaluated differential item functioning (DIF) by method of data collection using the R software package, lordif. For constructs that showed no DIF, we concluded equivalence across modes if the equivalence margin, defined as ± 0.20 × pooled SD, completely surrounds 95% confidence intervals (CI's) for difference in mean score. If the 95% CI fell totally outside the equivalence margin, we concluded systematic score difference by modes. If the 95% CI partly overlaps the equivalence margin, we concluded neither equivalence nor difference., Results: For all constructs, no DIF of any kind was found for the three modes. The scores on paper and tablet were more comparable than between IVR and other modes but none of the 95% CI's were completely outside the equivalence margins, in which we established neither equivalence nor difference. Percentages of missing values were comparable for paper and tablet modes. Percentages of missing values were higher for IVR (2.3% to 6.5% depending on measures) compared to paper and tablet modes (0.7% to 3.3% depending on measures and modes), which was attributed to random technical difficulties experienced in some centers., Conclusion: Across all mode comparisons, there were some measures with CI's not completely contained within the margin of small effect. Two visual modes agreed more than visual-auditory pairs. IVR may induce differences in scores unrelated to constructs being measured in comparison with paper and tablet. The users of the surveys should consider using IVR only when paper and computer administration is not feasible., (© 2021. The Author(s).)

Purpose: As the prevalence of provider burnout continues to increase, it is critical to identify interventions that may impact provider satisfaction, such as an integrated clinical pharmacist. This study aimed to assess the perceived effect of pharmacist integration on primary care provider satisfaction and drivers of provider burnout in the primary care setting., Methods: A cross-sectional survey with 11 questions across 4 domains was distributed to primary care providers in a large integrated health system., Results: Of 295 providers invited to take the survey, 119 responded (40% response rate). Most providers had worked with a pharmacist for at least 2 years and utilized them weekly or daily. At least 87% of provider respondents strongly agreed or somewhat agreed that the integrated clinical pharmacist reduced their workload by working directly with patients and non-provider staff, improved overall medication use, helped patients meet health goals and quality measures, and overall helped them to effectively manage their panel of patients. Providers found greater meaning in work through the presence of the clinical pharmacist, which allowed them more time to focus on professionally fulfilling aspects of their work and helped them feel less emotional exhaustion. Overall, 91% of providers were extremely satisfied with the clinical pharmacy service., Conclusions: These findings may be used to justify the expansion of clinical pharmacy services in primary care to practice areas experiencing problems with 4 specific drivers of provider burnout: workload and job demands, efficiency and resources, meaning in work, and social support and community at work., Competing Interests: Conflict of interest: None., (© Copyright 2021 by the American Board of Family Medicine.)

Objective: To (1) develop a patient-reported, multidomain functional assessment tool focused on medically ill patients in acute care settings; (2) characterize the measure's psychometric performance; and (3) establish clinically actionable score strata that link to easily implemented mobility preservation plans., Design: This article describes the approach that our team pursued to develop and characterize this tool, the Functional Assessment in Acute Care Multidimensional Computer Adaptive Test (FAMCAT). Development involved a multistep process that included (1) expanding and refining existing item banks to optimize their salience for hospitalized patients; (2) administering candidate items to a calibration cohort; (3) estimating multidimensional item response theory models; (4) calibrating the item banks; (5) evaluating potential multidimensional computerized adaptive testing (MCAT) enhancements; (6) parameterizing the MCAT; (7) administering it to patients in a validation cohort; and (8) estimating its predictive and psychometric characteristics., Setting: A large (2000-bed) Midwestern Medical Center., Participants: The overall sample included 4495 adults (2341 in a calibration cohort, 2154 in a validation cohort) who were admitted either to medical services with at least 1 chronic condition or to surgical/medical services if they required readmission after a hospitalization for surgery (N=4495)., Intervention: Not applicable., Main Outcome Measures: Not applicable., Results: The FAMCAT is an instrument designed to permit the efficient, precise, low-burden, multidomain functional assessment of hospitalized patients. We tried to optimize the FAMCAT's efficiency and precision, as well as its ability to perform multiple assessments during a hospital stay, by applying cutting edge methods such as the adaptive measure of change (AMC), differential item functioning computerized adaptive testing, and integration of collateral test-taking information, particularly item response times. Evaluation of these candidate methods suggested that all may enhance MCAT performance, but none were integrated into initial MCAT parameterization., Conclusions: The FAMCAT has the potential to address a longstanding need for structured, frequent, and accurate functional assessment among patients hospitalized with medical diagnoses and complications of surgery., (© 2021 The Authors.)

Practice changing standardization of lower extremity lymphedema quantitative measurements with integrated patient reported outcomes will likely refine and redefine the optimal risk-reduction strategies to diminish the devastating limb-related dysfunction and morbidity associated with treatment of gynecologic cancers. The National Cancer Institute (NCI), Division of Cancer Prevention brought together a diverse group of cancer treatment, therapy and patient reported outcomes experts to discuss the current state-of-the-science in lymphedema evaluation with the potential goal of incorporating new strategies for optimal evaluation of lymphedema in future developing gynecologic clinical trials., Competing Interests: Declaration of Competing Interest Dr. Walker, Dr. Carlson, Dr. Carter, Dr. Covens, Dr. Tanner, Dr. Amer, Dr. Hayes, Dr. Lopez-Acevedo, Dr. Davidson, Dr. Schaverien, Dr. Ghamande, Dr. Cheville, Dr. Yost, Dr. Schmitz, Dr.Ford and Michael Bernas report no conflicts of interest. Dr. Russo and Dr. McCaskill-Steven report grants from government to support this workshop. Dr. Ward reports personal fees from Impedimed Inc., outside the submitted work. Dr. Ridner reports grants from Impedimed, during the conduct of the study. Dr. Taghian reports consultancy with PureTech Health, previous consultancy with VisionRT, grants from Adele McKinnon Research Fund for Breast Cancer-Related Lymphedema, grants from The Heinz Family Foundation, grants from The Olayan-Xefos Family Fund for Breast Cancer Research, grants from National Cancer Institute Award Number P50CA08393, grants from National Cancer Institute Award Number R01CA139118, non-financial support from Impedimed outside the submitted work. Cheryl. Brunelle is on the Scientific Advisory Board for PureTech Health outside the submitted work. Dr. Davidson reports speaking honorarium from Tesaro outside the submitted work. Dr. Ghamande reports consultancy/speaker with GSK/Tesaro outside the submitted work. Dr. Enserro reports grants from NRG Oncology NCORP, grants from NRG Oncology SDMC during the conduct of the study, outside the submitted work. Dr. Pugh reports other from Pfizer, other from Millennium outside the submitted work. Dr. Paskett reports grants from Merck Foundation, grants from Pfizer, other from Pfizer, grants from Komen Columbus Foundation, grants from Ohio Department of Health, grants from Breast Cancer Research Foundtaion, grants from NIH, other from FoxConn, grants from Social Impact Fund, grants from Komen Foundation, grants from PICORI outside the submitted work., (Published by Elsevier Inc.)

The impact of change in health behaviors (physical activity [PA], alcohol and smoking) on quality of life (QOL) in lymphoma survivors is not well understood. We evaluated the associations of health behaviors with QOL domains at diagnosis and at 3-year follow-up (FU3) in 2805 lymphoma survivors. We report clinically significant QOL score differences, defined as scores that exceeded a minimally important difference threshold and were statistically significant. Current smoking was associated with lower QOL at baseline ( p  < 0.01) and at FU3 ( p  < 0.01). Meeting the American Cancer Society PA guidelines was associated with better functional wellbeing and overall QOL at FU3 ( p  < 0.01). An increase in PA from baseline to FU3 was associated with improvement in physical, functional wellbeing and overall QOL at FU3 compared to baseline ( p  < 0.01). Thus, QOL in lymphoma survivors is associated with their health behaviors and active interventions to promote positive lifestyle changes in lymphoma survivors are needed.

The past decade witnessed a rapid rise in the public reporting of surgeon- and hospital-specific quality-of-care measures. However, patients' interpretations of star ratings and their importance relative to other considerations (for example, cost, distance traveled) are poorly understood. We conducted a discrete choice experiment in an outpatient setting (an academic joint arthroplasty practice) to study trade-offs that patients are willing to make in choosing a provider for a hypothetical total joint arthroplasty. Two hundred consecutive new patients presenting for hip or knee pain in 2018 were included. The average patient was willing to pay $2,607 and $3,152 extra for an additional hospital or physician star, respectively, and an extra $11.45 to not travel an extra mile for arthroplasty care. History of prior surgery and prior experience with rating systems reduced the relative value of an incremental star by $539.25 and $934.50, respectively. Patients appear willing to accept significantly higher copayments for higher quality of care, and surgeon quality seems relatively more important than hospital quality. Further study is needed to understand the value and trust patients place in publicly reported hospital and surgeon quality ratings.

Background: Researchers and clinicians studying symptoms experienced by people with cancer must choose from various scales. It would be useful to know how the scores on one measure translate to another., Methods: Using item response theory (IRT) with the single-group design, in which the same sample answers all measures, we produced crosswalk tables linking five 0-10 numeric rating scale (NRS) and 15 items from Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE, scored on a 1-5 scale) to the T-Score metric of six different scales from the NIH Patient reported Outcomes Measurement Information System (PROMIS®). The constructs, for which we conducted linking, include emotional distress-anxiety, emotional distress-depression, fatigue, sleep disturbance, pain intensity, and pain interference. We tested the IRT linking assumption of construct similarity between measures by comparing item content and testing unidimensionality of item sets comprising each construct. We also investigated the correlation of the measures to be linked and, by inspecting standardized mean differences, whether the linkage is invariant across age and gender subgroups. For measures that satisfied the assumptions, we conducted linking., Results: In general, an NRS score of 0 corresponded to about 38.2 on the PROMIS T-Score scale (mean = 50; SD = 10); whereas an NRS score of 10 corresponded to a PROMIS T-Score of approximately 72.7. Similarly, the lowest/best score of 1 on PRO-CTCAE corresponded to 39.8 on T-score scale and the highest/worst score of 5 corresponded to 72.0., Conclusion: We produced robust linking between single item symptom measures and PROMIS short forms.