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Abstract: Background: Medical informatics has been guided by an individual-centered model of human cognition, inherited from classical theory of mind, in which knowledge, problem-solving, and information-processing responsible for intelligent behavior all derive from the inner workings of an individual agent. Objectives and results: In this paper we argue that medical informatics commitment to the classical model of cognition conflates the processing performed by the minds of individual agents with the processing performed by the larger distributed activity systems within which individuals operate. We review trends in cognitive science that seek to close the gap between general-purpose models of cognition and applied considerations of real-world human performance. One outcome is the theory of distributed cognition, in which the unit of analysis for understanding performance is the activity system which comprises a group of human actors, their tools and environment, and is organized by a particular history of goal-directed action and interaction. Conclusion: We describe and argue for the relevance of distributed cognition to medical informatics, both for the study of human performance in healthcare and for the design of technologies meant to enhance this performance. [Copyright &y& Elsevier]

Background: There is an urgent need for evidence on how interventions can prevent or mitigate cancer-related financial hardship. Our objectives are to compare self-reported financial hardship, quality of life, and health services use between patients receiving a financial navigation intervention versus a comparison group at 12 months follow-up, and to assess patient-level factors associated with dose received of a financial navigation intervention.Methods: The Cancer Financial Experience (CAFÉ) study is a multi-site randomized controlled trial (RCT) with individual-level randomization. Participants will be offered either brief (one financial navigation cycle, Arm 2) or extended (three financial navigation cycles, Arm 3) financial navigation. The intervention period for both Arms 2 and 3 is 6 months. The comparison group (Arm 1) will receive enhanced usual care. The setting for the CAFÉ study is the medical oncology and radiation oncology clinics at two integrated health systems in the Pacific Northwest. Inclusion criteria includes age 18 or older with a recent cancer diagnosis and visit to a study clinic as identified through administrative data. Outcomes will be assessed at 12-month follow-up. Primary outcomes are self-reported financial distress and health-related quality of life. Secondary outcomes are delayed or foregone care; receipt of medical financial assistance; and account delinquency. A mixed methods exploratory analysis will investigate factors associated with total intervention dose received.Discussion: The CAFÉ study will provide much-needed early trial evidence on the impact of financial navigation in reducing cancer-related financial hardship. It is theory-informed, clinic-based, aligned with patient preferences, and has been developed following preliminary qualitative studies and stakeholder input. By design, it will provide prospective evidence on the potential benefits of financial navigation on patient-relevant cancer outcomes. The CAFÉ trial's strengths include its broad inclusion criteria, its equity-focused sampling plan, its novel intervention developed in partnership with clinical and operations stakeholders, and mixed methods secondary analyses related to intervention dose offered and dose received. The resulting analytic dataset will allow for rich mixed methods analysis and provide critical information related to implementation of the intervention should it prove effective.Trial Registration: ClinicalTrials.gov NCT05018000 . August 23, 2021. [ABSTRACT FROM AUTHOR]

INTRODUCTION: The Cancer Health Assessments Reaching Many study seeks to reduce disparities in genomic care. Two patient advisory committees (PACs) were formed, 1 of English speakers and 1 of Spanish speakers, to vet study processes and materials. Stakeholder engagement in research is relatively new, and we know little about how stakeholders view their engagement. We wanted to learn how patient stakeholders viewed the process, to inform future patient engagement efforts. METHODS: Patients at 2 study sites were invited to serve on 2 PACs. We used an iterative engagement process to solicit and incorporate patient feedback. Much of the PAC feedback on study materials and processes was incorporated. Using surveys and exit interviews, we evaluated stakeholders' experiences as PAC members. RESULTS: Nearly all PAC members felt satisfied and included in the study decisions, but surveys and exit interviews suggested the need to improve communications. DISCUSSION: Although most believed their feedback was used, and most felt included in study decisions, some said they did not know whether their opinions were used to modify materials or approaches. This suggests the need to explain to patient stakeholders the extent to which their feedback was used and to inform them about the impact that other stakeholders, such as institutional review boards, have on decisions. CONCLUSION: Our evaluation highlights the value of dedicating resources to stakeholder engagement. Although gathering patient feedback on study materials and processes introduced time constraints and complexity to our study, adaptations to materials and processes furthered study goals. [ABSTRACT FROM AUTHOR]

Background: Chronic pain is common, disabling, and costly. Few clinical trials have examined cognitive behavioral therapy (CBT) interventions embedded in primary care settings to improve chronic pain among those receiving long-term opioid therapy.Objective: To determine the effectiveness of a group-based CBT intervention for chronic pain.Design: Pragmatic, cluster randomized controlled trial. (ClinicalTrials.gov: NCT02113592).Setting: Kaiser Permanente health care systems in Georgia, Hawaii, and the Northwest.Participants: Adults (aged ≥18 years) with mixed chronic pain conditions receiving long-term opioid therapy.Intervention: A CBT intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team (behaviorist, nurse, physical therapist, and pharmacist) versus usual care.Measurements: Self-reported pain impact (primary outcome, as measured by the PEGS scale [pain intensity and interference with enjoyment of life, general activity, and sleep]) was assessed quarterly over 12 months. Pain-related disability, satisfaction with care, and opioid and benzodiazepine use based on electronic health care data were secondary outcomes.Results: A total of 850 patients participated, representing 106 clusters of primary care providers (mean age, 60.3 years; 67.4% women); 816 (96.0%) completed follow-up assessments. Intervention patients sustained larger reductions on all self-reported outcomes from baseline to 12-month follow-up; the change in PEGS score was -0.434 point (95% CI, -0.690 to -0.178 point) for pain impact, and the change in pain-related disability was -0.060 point (CI, -0.084 to -0.035 point). At 6 months, intervention patients reported higher satisfaction with primary care (difference, 0.230 point [CI, 0.053 to 0.406 point]) and pain services (difference, 0.336 point [CI, 0.129 to 0.543 point]). Benzodiazepine use decreased more in the intervention group (absolute risk difference, -0.055 [CI, -0.099 to -0.011]), but opioid use did not differ significantly between groups.Limitation: The inclusion of only patients with insurance in large integrated health care systems limited generalizability, and the clinical effect of change in scores is unclear.Conclusion: Primary care-based CBT, using frontline clinicians, produced modest but sustained reductions in measures of pain and pain-related disability compared with usual care but did not reduce use of opioid medication.Primary Funding Source: National Institutes of Health. [ABSTRACT FROM AUTHOR]

Background: As more states legalize cannabis for medical and recreational use, people increasingly use cannabis to treat medical conditions and associated symptoms. The prevalence and utility of cannabis for cancer-related symptoms may be clarified by examining cannabis use among patients with a common cancer diagnosis. We aimed to determine the prevalence of cannabis use among colorectal cancer (CRC) survivors and its associations with quality of life (QoL) and cancer-related symptomatology.Methods: A cross-sectional survey of patient-reported QoL outcomes and behaviors, including cannabis use, was conducted within the Patient Outcomes To Advance Learning network's (PORTAL) CRC Cohort. The cohort included a population-based sample of healthcare system members ≥18 years old diagnosed with adenocarcinoma of the colon or rectum from 2010 through 2016. We assessed the association between cannabis use and QoL using the European Organization for Research and Treatment of Cancer QLQ-C30 summary score.Results: Of the 1784 respondents, 293 (16.4%) reported cannabis use following CRC diagnosis. Current tobacco smokers were more likely to use cannabis compared to former or never tobacco smokers (adjusted odds ratio [aOR] 2.71, 95% confidence interval [CI] 1.56 to 4.70). Greater alcohol use (> 4 drinks per month versus ≤4 drinks per month) was associated with cannabis use (aOR 2.17, 95% CI 1.65 to 2.85). There was an association between cannabis use and cancer stage at diagnosis, with stage 3 or 4 CRC patients more likely to use cannabis than stage 1 or 2 CRC patients (aOR 1.68, 95% CI 1.25 to 2.25). After adjusting for demographics, medical comorbidities, stage and site of CRC diagnosis, and prescription opioid use, people who used cannabis had significantly lower QoL than people who did not use cannabis (difference of - 6.14, 95% CI - 8.07 to - 4.20).Conclusion: Among CRC survivors, cannabis use was relatively common, associated with more advanced stages of disease, associated with tobacco and alcohol use, and not associated with better QoL. Clinicians should inquire about cannabis use among their patients and provide evidence-based recommendations for cancer-related symptoms. [ABSTRACT FROM AUTHOR]

Purpose: The Bladder Cancer Quality of Life Study collected detailed and sensitive patient-reported outcomes from bladder cancer survivors in the period after bladder removal surgery, when participation in survey research may present a burden. This paper describes the study recruitment methods and examines the response rates and patterns of missing data.Methods: Detailed surveys focusing on quality of life, healthcare decision-making, and healthcare expenses were mailed to patients 5-7 months after cystectomy. We conducted up to 10 follow-up recruitment calls. We analyzed survey completion rates following each contact in relation to demographic and clinical characteristics, and patterns of missing data across survey content areas.Results: The overall response rate was 71% (n = 269/379). This was consistent across patient clinical characteristics; response rates were significantly higher among patients over age 70 and significantly lower among racial and ethnic minority patients compared to non-Hispanic white patients. Each follow-up contact resulted in marginal survey completion rates of at least 10%. Rates of missing data were low across most content areas, even for potentially sensitive questions. Rates of missing data differed significantly by sex, age, and race/ethnicity.Conclusions: Despite the effort required to participate in research, this population of cancer survivors showed willingness to share detailed information about quality of life, health care decision-making, and expenses, soon after major cancer surgery. Additional contacts were effective at increasing participation. Response patterns differed by race/ethnicity and other demographic factors. Our data collection methods show that it is feasible to gather detailed patient-reported outcomes during this challenging period. [ABSTRACT FROM AUTHOR]

Background: Opioid treatment for chronic pain has garnered heightened public attention and political pressure to control a devastating public health crisis in the United States (U.S.). Resulting policy changes, together with ongoing public and political attention, have pushed health care systems and providers to lower doses or deprescribe and taper patients off opioids. However, little attention has been paid to the impact of such practice changes on patients who had relied on opioid treatment to manage their chronic pain. The aim of this article is to explore experiences with opioid-related care under aggressive tapering efforts and concomitant heightened monitoring and institutional oversight among patients with chronic pain in an integrated delivery system through in-depth interviews.Methods: We interviewed 97 patients with chronic pain who were assigned to the usual care arm of the Pain Program for Active Coping and Training (PPACT) study. These patients had been prescribed opioids as part of their treatment regimens and taken opioids closely monitored by their health care providers. We followed the framework method for coding and analysing transcripts using NVivo 12.Results: The experiences of these patients during this period of change can be understood through three interconnected themes: (1) many patients taking opioids experience debilitating physical side effects; (2) navigating opioid treatment contributes to significant emotional distress among many patients with chronic pain and; (3) the quality of patients' relationship with their primary care provider can be negatively affected by negotiations regarding long-term opioid treatment for chronic pain.Conclusion: We highlight the importance of utilizing communication approaches that are patient-centered and include shared decision making during the tapering and/or deprescribing processes of opioids and ensuring alternative pain treatments are available to patients with chronic pain. [ABSTRACT FROM AUTHOR]

Objective: To assess the relative contributions of patient and surgeon factors for predicting selection of ileal conduit (IC), neobladder (NB), or continent pouch (CP) urinary diversions (UD) for patients diagnosed with muscle-invasive/high-risk nonmuscle invasive bladder cancer. This information is needed to enhance research comparing cancer survivors' outcomes across different surgical treatment options.Methods: Bladder cancer patients' age ≥21 years with cystectomy/UD performed from January 2010 to June 2015 in 3 Kaiser Permanente regions were included. All patient and surgeon data were obtained from electronic health records. A mixed effects logistic regression model was used treating surgeon as a random effect and region as a fixed effect.Results: Of 991 eligible patients, 794 (80%) received IC. One hundred sixty-nine surgeons performed the surgeries and accounted for a sizeable proportion of the variability in patient receipt of UD (intraclass correlation coefficient = 0.26). The multilevel model with only patient factors showed good fit (area under the curve = 0.93, Hosmer-Lemeshow test P = .44), and older age, female sex, estimated glomerular filtration rate <45, 4+ comorbidity index score, and stage III/IV tumors were associated with higher odds of receiving an IC vs neobladder/continent pouch. However, including surgeon factors (annual cystectomy volume, specialty training, clinical tenure) had no association (P = .29).Conclusion: In this community setting, patient factors were major predictors of UD received. Surgeons also played a substantial role, yet clinical training and experience were not major predictors. Surgeon factors such as beliefs about UD options and outcomes should be explored. [ABSTRACT FROM AUTHOR]

Background Chronic pain is one of the most common, disabling, and expensive public health problems in the United States. Interdisciplinary pain management treatments that employ behavioral approaches have been successful in helping patients with chronic pain reduce symptoms and regain functioning. However, most patients lack access to such treatments. We are conducting a pragmatic clinical trial to test the hypothesis that patients who receive an interdisciplinary biopsychosocial intervention, the Pain Program for Active Coping and Training (PPACT), at their primary care clinic will have a greater reduction in pain impact in the year following than patients receiving usual care. Methods/design This is an effectiveness-implementation hybrid pragmatic clinical trial in which we randomize clusters of primary care providers and their patients with chronic pain who are on long-term opioid therapy to 1) receive an interdisciplinary behavioral intervention in conjunction with their current health care or 2) continue with current health care services. Our primary outcome is pain impact (a composite of pain intensity and pain-related interference) measured using the PEG, a validated three-item assessment. Secondary outcomes include pain-related disability, patient satisfaction, opioids dispensed and health care utilization. An economic evaluation assesses the resources and costs necessary to deliver the intervention and its cost-effectiveness compared with usual care. A formative evaluation employs mixed methods to understand the context for implementation in the participating health care systems. Discussion This trial will inform the feasibility of implementing interdisciplinary behavioral approaches to pain management in the primary care setting, potentially providing a more effective, safer, and more satisfactory alternative to opioid-based chronic pain treatment. Clinical Trials Registration Number: NCT02113592 [ABSTRACT FROM AUTHOR]

Opioid use disorder (OUD) contributes to rising morbidity and mortality. Life-saving OUD treatments can be provided in primary care but most patients with OUD don't receive treatment. Comorbid depression and other conditions complicate OUD management, especially in primary care. The MI-CARE trial is a pragmatic randomized encouragement (Zelen) trial testing whether offering collaborative care (CC) to patients with OUD and clinically-significant depressive symptoms increases OUD medication treatment with buprenorphine and improves depression outcomes compared to usual care. Adult primary care patients with OUD and depressive symptoms (n ≥ 800) from two statewide health systems: Kaiser Permanente Washington and Indiana University Health are identified with computer algorithms from electronic Health record (EHR) data and automatically enrolled. A random sub-sample (50%) of eligible patients is offered the MI-CARE intervention: a 12-month nurse-driven CC intervention that includes motivational interviewing and behavioral activation. The remaining 50% of the study cohort comprise the usual care comparison group and is never contacted. The primary outcome is days of buprenorphine treatment provided during the intervention period. The powered secondary outcome is change in Patient Health Questionnaire (PHQ)-9 depression scores. Both outcomes are obtained from secondary electronic healthcare sources and compared in "intent-to-treat" analyses. MI-CARE addresses the need for rigorous encouragement trials to evaluate benefits of offering CC to generalizable samples of patients with OUD and mental health conditions identified from EHRs, as they would be in practice, and comparing outcomes to usual primary care. We describe the design and implementation of the trial, currently underway. Trial Registration: ClinicalTrials.gov Identifier: NCT05122676. Clinical trial registration date: November 17, 2021. [ABSTRACT FROM AUTHOR]

Population-based carrier screening is limited to well-studied or high-impact genetic conditions for which the benefits may outweigh the associated harms and costs. As the cost of genome sequencing declines and availability increases, the balance of risks and benefits may change for a much larger number of genetic conditions, including medically actionable additional findings. We designed an RCT to evaluate genomic clinical sequencing for women and partners considering a pregnancy. All results are placed into the medical record for use by healthcare providers. Through quantitative and qualitative measures, including baseline and post result disclosure surveys, post result disclosure interviews, 1–2 year follow-up interviews, and team journaling, we are obtaining data about the clinical and personal utility of genomic carrier screening in this population. Key outcomes include the number of reportable carrier and additional findings, and the comparative cost, utilization, and psychosocial impacts of usual care vs. genomic carrier screening. As the study progresses, we will compare the costs of genome sequencing and usual care as well as the cost of screening, pattern of use of genetic or mental health counseling services, number of outpatient visits, and total healthcare costs. This project includes novel investigation into human reactions and responses from would-be parents who are learning information that could both affect a future pregnancy and their own health. [ABSTRACT FROM AUTHOR]

Introduction Sexual dysfunction is a treatment sequela in survivors of rectal cancer (RC). Differences in health-related quality of life (HRQOL) can occur based on ostomy status (permanent ostomy vs anastomosis). Aim To describe alterations in sexual function and HRQOL based on ostomy status in long-term (≥5 years) survivors of RC. Methods Survivors of RC with an ostomy (n = 181) or anastomosis (n = 394) were surveyed using validated HRQOL and functional status tools. We compared sexuality outcomes between the ostomy and anastomosis groups and reported differences adjusted for clinical and demographic characteristics. Qualitative data from one open-ended question on survivors' greatest challenges since their surgery were analyzed to explore sexuality, symptoms, and relationships. Main Outcome Measures Whether sexually active, satisfaction with sexual activity, and select sexual dysfunction items from the Modified City of Hope Quality of Life-Colorectal. Results Survivors with a permanent ostomy were more likely to have been sexually inactive after surgery if it occurred before 2000 and experience dissatisfaction with appearance, interference with personal relationships and intimacy, and lower overall HRQOL. Female survivors of RC with an ostomy were more likely to have problems with vaginal strictures and vaginal pain after surgery that persisted at the time of the survey (≥5 years later). Radiation treatment, tumor stage, soilage of garments in bed, and higher Charlson-Deyo comorbidity scores were negatively associated with outcomes. Six qualitative themes emerged: loss of and decreased sexual activity, psychological issues with sexual activity, physical issues with sexual activity, partner rejection, ostomy interference with sexual activity, and positive experiences with sexuality. Conclusion Sexual dysfunction is a common long-term sequela of RC treatment, with more problems observed in survivors with a permanent ostomy. This warrants widespread implementation of targeted interventions to manage sexual dysfunction and improve HRQOL for these survivors. [ABSTRACT FROM AUTHOR]

Objective: To identify challenges, lessons learned and best practices for service-oriented clinical decision support, based on the results of the Clinical Decision Support Consortium, a multi-site study which developed, implemented and evaluated clinical decision support services in a diverse range of electronic health records.Methods: Ethnographic investigation using the rapid assessment process, a procedure for agile qualitative data collection and analysis, including clinical observation, system demonstrations and analysis and 91 interviews.Results: We identified challenges and lessons learned in eight dimensions: (1) hardware and software computing infrastructure, (2) clinical content, (3) human-computer interface, (4) people, (5) workflow and communication, (6) internal organizational policies, procedures, environment and culture, (7) external rules, regulations, and pressures and (8) system measurement and monitoring. Key challenges included performance issues (particularly related to data retrieval), differences in terminologies used across sites, workflow variability and the need for a legal framework.Discussion: Based on the challenges and lessons learned, we identified eight best practices for developers and implementers of service-oriented clinical decision support: (1) optimize performance, or make asynchronous calls, (2) be liberal in what you accept (particularly for terminology), (3) foster clinical transparency, (4) develop a legal framework, (5) support a flexible front-end, (6) dedicate human resources, (7) support peer-to-peer communication, (8) improve standards.Conclusion: The Clinical Decision Support Consortium successfully developed a clinical decision support service and implemented it in four different electronic health records and four diverse clinical sites; however, the process was arduous. The lessons identified by the Consortium may be useful for other developers and implementers of clinical decision support services. [ABSTRACT FROM AUTHOR]

Purpose: Examination of reliability and validity of a specialized health-related quality of life questionnaire for rectal cancer (RC) survivors (≥5 years post-diagnosis). Methods: We mailed 1,063 Kaiser Permanente (KP) RC survivors (313 ostomy and 750 anastomosis) a questionnaire containing the Modified City of Hope Quality of Life-Ostomy (mCOH-QOL-O), SF-12v2, Duke-UNC Functional Social Support Questionnaire (FSSQ), and Memorial Sloan-Kettering Cancer Center Bowel Function Index (BFI). We adapted certain BFI items for use by subjects with intestinal ostomies. We evaluated reliability for all instruments with inter-item correlations and Cronbach's alpha. We assessed construct validity only for the BFI in the ostomy group, because such use has not been reported. Results: The overall response rate was 60.5 % (577 respondents/953 eligible). Compared with non-responders, participants were on average 2 years younger and more likely non-Hispanic white, resided in educationally non-deprived areas, and had KP membership through a group. The mCOH-QOL-O, SF-12, and FSSQ were found to be highly reliable for RC survivors. In the ostomy group, BFI Urgency/Soilage and Dietary subscales were found to be reliable, but Frequency was not. Factor analysis supported the construct of Urgency/Soilage and Dietary subscales in the ostomy group, although one item had a moderate correlation with all three factors. The BFI also demonstrated good concurrent validity with other instruments in the ostomy group. Conclusions: With possible exception of the BFI Frequency subscale in populations with ostomies, components of our survey can be used for the entire population of RC survivors, no matter whether they received anastomosis or ostomy. [ABSTRACT FROM AUTHOR]

Background: Nonmuscle-invasive bladder cancer (NMIBC) disproportionately affects older adults who often have coexisting chronic conditions such as metabolic syndrome (MetS). Although prior research suggests that MetS is a risk factor for NMIBC, limited data exists on whether MetS is associated with NMIBC recurrence. Our objective was to evaluate the association between MetS and recurrence in older adults treated for NMIBC.Methods: We identified 1,485 older (age ≥60 years) NMIBC patients (American Joint Committee on Cancer Stage ≤1) from 2community-based health systems. Using data from the health systems' electronic medical record, MetS was defined as the presence of three of the following: diagnosis codes indicating hypertension, hyperlipidemia, diabetes, or body mass index >30. Follow up time was determined by date of the last follow up in the tumor registry and censored at 10 years. Cox proportional hazards regression of time to recurrence that accounts for the competing risk of death included adjustment for age, sex, smoking status, health system, NMIBC stage/grade, tumor size, and number of specimens with cancer.Results: Overall, 341 patients (23%) met MetS criteria. Median follow up was 5.9 years and 582 patients (39.2%) died. Patients with MetS were more frequently male (84.2%), and mostly current/former smokers (82.6%). By 10 years, 34.1% of the cohort had experienced a recurrence. After accounting for the competing risk of death, there was no association between MetS and time to recurrence (adjusted hazard ratio, 0.88, 95% confidence interval 0.70-1.11, P = 0.28). Patients without MetS had more 0a/low grade recurrences (49.1% vs. 41.4%), though differences were not significant.Conclusion: We found no association between MetS and risk of NMIBC recurrence in this large, multisite cohort of older adults with NMIBC. In order to design personalized care for older NMIBC patients, future research is needed to evaluate associations between common chronic conditions and a variety of oncologic outcomes. [ABSTRACT FROM AUTHOR]

Introduction: Few studies have evaluated the potential effects of aging-related conditions like frailty in older adults with cancer on informal caregivers. Our objective was to evaluate the association between the sum total of the aging-related conditions of older adults with non-muscle-invasive bladder cancer (NMIBC) and the strain reported by their informal caregivers., Materials and Methods: We conducted an explanatory sequential mixed methods cross-sectional survey study that recruited 81 dyads of older adults with NMIBC (age ≥ 65 at diagnosis) and their informal caregivers. Our outcome was measured by the Caregiver Strain Index (CSI), a self-reported measure of informal caregivers. Our exposure was the patient's deficit accumulation index (DAI), a validated composite measure of frailty derived from a geriatric assessment. A multivariable negative binomial regression was conducted to model CSI. We conducted qualitative thematic content analysis of responses to open-ended survey questions to understand specific types of caregiver strain and to identify coping strategies., Results: Mean ages of patients and caregivers were 79.4 years and 72.5 years, respectively. Most caregivers were spouses (75.3 %) and lived with the patient (80.2 %). Of patients, 54.3 % were robust, 29.6 % were pre-frail, and 16.1 % were frail. In the multivariable model, we found that patient DAI was significantly associated with CSI (adjusted incidence rate ratio 1.05, 95 % CI 1.02-1.09). The top three sources of strain identified by caregivers were emotional adjustments, medical management, and family adjustments. Coping strategies for each included self-management of emotions, self-education about bladder cancer, and social support, respectively., Discussion: In this cross-sectional study, we found that worsening frailty in an older adult with NMIBC was associated with greater informal caregiver strain. Informal caregivers reported challenges with emotional management, family dynamics, and medical tasks. These findings may inform longitudinal research and interventions to support informal caregivers who provide care for older adults with NMIBC., Competing Interests: Declaration of Competing Interest Matthew E. Nielsen serves as a paid consultant to the American Urological Association and to the American College of Physicians High Value Care Task Force and as a consultant/advisor to Grand Rounds (stock options). Tullika Garg was a Web MD paid consultant in 2020, and currently receives research funding from the Flume Catheter Company, LLC. Through 2021, Dr. Garg's immediate family member was an employee and stockholder of DRPLZ. All other authors report no conflicts., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Purpose: Bladder cancer is 1 of the most costly cancers, however there is limited research on medical care costs by type of urinary diversion. The objective of our study was to compare medical care costs of the 2 most common urinary diversions in the year following radical cystectomy., Methods: The Bladder Cancer Quality of Life Study included patients diagnosed with bladder cancer who underwent radical cystectomy and received an ileal conduit (IC, n = 821) or neobladder (NB, n = 181) in 3 integrated health systems. Medical care costs per patient per quarter were estimated for the year following cystectomy. Multivariable generalized linear models with a gamma distribution and log link were used to estimate mean monthly medical care costs (2022 USD$), adjusted for patient demographic and clinical characteristics., Results: In multivariable analysis, mean monthly costs per quarter were not significantly different between IC and NB patients in the 12 months following cystectomy. Overall, mean monthly costs in IC and NB patients were highest during the first quarter and decreased thereafter. Factors associated with higher mean costs across all quarters included presence of any complications and advanced tumor stage at cystectomy (all P < 0.001)., Conclusion: Our study addresses an important knowledge gap by quantifying the medical costs of bladder cancer patients by urinary diversion type and comparing costs of different treatment approaches. Studies that assess patient-reported outcomes and out-of-pocket costs, by urinary diversion type, are warranted to inform treatment decision-making and cost conversations., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: Qualitatively examine how community health clinics delivered cardiovascular disease (CVD) preventive care during COVID-19 using virtual care and related adaptations., Methods: Semi-structured interviews were conducted in 2021-2022 with nine clinician leaders from four clinics across the country that share an electronic health record. Interviews covered: (1) the pandemic's impact on preventive care delivery, (2) the adaptation and role of virtual care, and (3) management of CVD risk in this context. Collected data were analyzed using a thematic analysis approach., Results: Staff reported substantial pros and cons to virtual care for CVD risk management. It was seen as useful for general check-ins with patients. However, without current laboratory results and vital measurements, providers found it challenging to assess patient CVD risk and direct care accordingly., Conclusion: Findings add to the evolving evidence base that the necessary pivot to virtual care during the pandemic spurred innovations but also created limitations and delays in delivering appropriate preventive care., Competing Interests: There are no conflicts of interest., (Copyright: © 2024 Journal of Family Medicine and Primary Care.)

Background: Community health center (CHC) patients experience a disproportionately high prevalence of chronic conditions and barriers to accessing technologies that might support the management of these conditions. One such technology includes tools used for remote patient monitoring (RPM), the use of which surged during the COVID-19 pandemic., Objective: The aim of this study was to assess how a CHC implemented an RPM program during the COVID-19 pandemic., Methods: This retrospective case study used a mixed methods explanatory sequential design to evaluate a CHC's implementation of a suite of RPM tools during the COVID-19 pandemic. Analyses used electronic health record-extracted health outcomes data and semistructured interviews with the CHC's staff and patients participating in the RPM program., Results: The CHC enrolled 147 patients in a hypertension RPM program. After 6 months of RPM use, mean systolic blood pressure (BP) was 13.4 mm Hg lower and mean diastolic BP 6.4 mm Hg lower, corresponding with an increase in hypertension control (BP<140/90 mm Hg) from 33.3% of patients to 81.5%. Considerable effort was dedicated to standing up the program, reinforced by organizational prioritization of chronic disease management, and by a clinician who championed program implementation. Noted barriers to implementation of the RPM program were limited initial training, lack of sustained support, and complexities related to the RPM device technology., Conclusions: While RPM technology holds promise for addressing chronic disease management, successful RPM program requires substantial investment in implementation support and technical assistance., (©Rose Gunn, Shelby L Watkins, Dave Boston, A Gabriela Rosales, Stefan Massimino, Suparna Navale, Stephanie L Fitzpatrick, John Dickerson, Rachel Gold, George Lee, Carmit K McMullen. Originally published in JMIR Formative Research (https://formative.jmir.org), 09.07.2024.)

Objective: Electronic health record (EHR)-based shared decision-making (SDM) and clinical decision support (CDS) systems can improve cardiovascular disease (CVD) care quality and risk factor management. Use of the CV Wizard system showed a beneficial effect on high-risk community health center (CHC) patients' CVD risk within an effectiveness trial, but system adoption was low overall. We assessed which multi-level characteristics were associated with system use., Materials and Methods: Analyses included 80 195 encounters with 17 931 patients with high CVD risk and/or uncontrolled risk factors at 42 clinics in September 2018-March 2020. Data came from the CV Wizard repository and EHR data, and a survey of 44 clinic providers. Adjusted, mixed-effects multivariate Poisson regression analyses assessed factors associated with system use. We included clinic- and provider-level clustering as random effects to account for nested data., Results: Likelihood of system use was significantly higher in encounters with patients with higher CVD risk and at longer encounters, and lower when providers were >10 minutes behind schedule, among other factors. Survey participants reported generally high satisfaction with the system but were less likely to use it when there were time constraints or when rooming staff did not print the system output for the provider., Discussion: CHC providers prioritize using this system for patients with the greatest CVD risk, when time permits, and when rooming staff make the information readily available. CHCs' financial constraints create substantial challenges to addressing barriers to improved system use, with health equity implications., Conclusion: Research is needed on improving SDM and CDS adoption in CHCs., Trial Registration: ClinicalTrials.gov, NCT03001713, https://clinicaltrials.gov/., (© The Author(s) 2023. Published by Oxford University Press on behalf of the American Medical Informatics Association.)

Background: Chronic pain is prevalent and costly; cost-effective nonpharmacological approaches that reduce pain and improve patient functioning are needed., Objective: Report the incremental cost-effectiveness ratio (ICER), compared with usual care, of cognitive behavioral therapy aimed at improving functioning and pain among patients with chronic pain on long-term opioid treatment., Design: Economic evaluation conducted alongside a pragmatic cluster randomized trial., Subjects: Adults with chronic pain on long-term opioid treatment (N=814)., Intervention: A cognitive behavioral therapy intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team (behaviorists, nurses) with additional support from physical therapists, and pharmacists., Outcome Measures: Cost per quality adjusted life year (QALY) gained, and cost per additional responder (≥30% improvement on standard scale assessment of Pain, Enjoyment, General Activity, and Sleep). Costs were estimated as-delivered, and replication., Results: Per patient intervention replication costs were $2145 ($2574 as-delivered). Those costs were completely offset by lower medical care costs; inclusive of the intervention, total medical care over follow-up was $1841 lower for intervention patients. Intervention group patients also had greater QALY and responder gains than did controls. Supplemental analyses using pain-related medical care costs revealed ICERs of $35,000, and $53,000 per QALY (for replication, and as-delivered intervention costs, respectively); the ICER when excluding patients with outlier follow-up costs was $106,000., Limitations: Limited to 1-year follow-up; identification of pain-related utilization potentially incomplete., Conclusion: The intervention was the optimal choice at commonly accepted levels of willingness-to-pay for QALY gains; this finding was robust to sensitivity analyses., Competing Interests: R.A.D. reports royalties from UpToDate for authoring topics on low back pain. The remaining authors declare no conflict of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose: There is a critical need for genomic medicine research that reflects and benefits socioeconomically and ancestrally diverse populations. However, disparities in research populations persist, highlighting that traditional study designs and materials may be insufficient or inaccessible to all groups. New approaches can be gained through collaborations with patient/community stakeholders. Although some benefits of stakeholder engagement are recognized, routine incorporation into the design and implementation of genomics research has yet to be realized., Methods: The National Institutes of Health-funded Clinical Sequencing Evidence-Generating Research (CSER) consortium required stakeholder engagement as a dedicated project component. Each CSER project planned and carried out stakeholder engagement activities with differing goals and expected outcomes. Examples were curated from each project to highlight engagement strategies and outcomes throughout the research lifecycle from development through dissemination., Results: Projects tailored strategies to individual study needs, logistical constraints, and other challenges. Lessons learned include starting early with engagement efforts across project stakeholder groups and planned flexibility to enable adaptations throughout the project lifecycle., Conclusion: Each CSER project used more than 1 approach to engage with relevant stakeholders, resulting in numerous adaptations and tremendous value added throughout the full research lifecycle. Incorporation of community stakeholder insight improves the outcomes and relevance of genomic medicine research., Competing Interests: Conflict of Interest The authors declare no conflict of interest., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Lynch syndrome (LS) is the most common inherited cause of colorectal and endometrial cancers. Identifying individuals at risk for LS without personal cancer history requires detailed collection and assessment of family health history. However, barriers exist to family health history collection, especially in historically underserved populations. To improve LS risk assessment in historically underserved populations, we adapted the provider-facing PREdiction Model for gene Mutations (PREMM 5 ™ model), a validated LS risk assessment model, into a patient-facing electronic application through an iterative development process involving expert and patient stakeholders. We report on preliminary findings based on the first 500 individuals exposed to the adapted application in a primary care population enriched for low-literacy and low-resource patients. Major adaptations to the PREMM 5 ™ provider module included reduction in reading level, addition of interactive literacy aids, incorporation of family history assessment for both maternal and paternal sides of the family, and inclusion of questions about individual relatives or small groups of relatives to reduce cognitive burden. In the first 500 individuals, 90% completed the PREMM 5 ™ independently; of those, 94% did so in 5 min or less (ranged from 0.2 to 48.8 min). The patient-facing application was able to accurately classify 84% of patients as having clinically significant or not clinically significant LS risk. Our preliminary results suggest that in this diverse study population, most participants were able to rapidly, accurately, and independently complete an interactive application collecting family health history assessment that accurately assessed for Lynch syndrome risk., (© 2021. The Author(s).)

Purpose: To evaluate whether limited participation in life activities is associated with quality of life (QOL) in rectal cancer survivors, and if so, whether this association is independent of bowel function difficulties., Methods: We surveyed rectal cancer survivors from four healthcare systems about their QOL, bowel function, and participation in life activities. Additional demographic and clinical variables were extracted from the electronic health record. We examined independent associations between bowel function, participation in life activities, and QOL, controlling for potential confounders. We also identified factors, including ostomy status, that correlate with participation in life activities., Results: Of the 527 respondents, 52% were male, 80% were non-Hispanic white, and the mean age was 63. In fully adjusted models for all rectal cancer survivors, participation in life activities was positively associated with QOL, while bowel function was not. Bowel function retained an independent association with QOL for those who previously had an ostomy and were therefore more likely to have a low rectal anastomosis. Lower participation in life activities was correlated with lower self-reported physical and cognitive function, younger age, financial difficulty, and being non-Hispanic white., Conclusions: Rectal cancer survivors' participation in life activities was strongly associated with QOL, even when controlling for numerous confounders, including bowel function. Identifying ways to improve participation in life activities may be critical to developing rehabilitative and other supportive interventions that optimize QOL among rectal cancer survivors., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Introduction: Treatment burden is emerging as an important patient-centered outcome for older adults with cancer who concurrently manage geriatric conditions. Our objective was to evaluate the contribution of geriatric conditions to treatment burden in older adults with non-muscle invasive bladder cancer (NMIBC)., Methods: We identified 73,395 Medicare beneficiaries age 66+ diagnosed with NMIBC (Stage

Background: Despite the increasing use and acceptance of technology in health care, there is limited evidence on the usefulness and appropriate use of telehealth in home-based palliative care (HBPC). As part of the process evaluation of a pragmatic trial of video visits in HBPC, we assessed clinician experience with video visit implementation. Methods: We assessed clinicians' experiences with and perception of the usefulness and appropriateness of video visits using anonymous surveys and brief qualitative interviews with a subset of survey participants. Qualitative analyses were guided by sociotechnical frameworks that emphasize technology's "value proposition" for its end users as being key to adoption. Results: Clinicians (36 physicians and 48 registered nurses) generally had favorable attitudes toward video visits and telehealth. Respondents felt confident in the skills needed to make their role in video visits successful. Clinicians were neutral on whether video visits were useful for their practice or enhanced the patient-caregiver experience. Clinicians found video visits to be most appropriate for follow-up care (as opposed to start of care). The interviews yielded two themes that complemented the survey findings: (1) factors enhancing the value proposition (positive responses from patients and families and convenience) and (2) factors diminishing the value proposition (issues related to the technology and scheduling). Discussion: Our findings provide insights into clinicians' experiences with implementing remote video physician consultations, facilitated by a nurse in the patient's home in the pre-COVID-19 era. Clinician views about video visits may have shifted with the pandemic, which occurred after our data collection was complete. Clinical Trials Registration No. NCT#03694431., Competing Interests: No competing financial interests exist., (© Thearis A. Osuji et al. 2020; Published by Mary Ann Liebert, Inc.)

Purpose: This study describes challenges faced while incorporating sometimes conflicting stakeholder feedback into study design and development of patient-facing materials for a translational genomics study aiming to reduce health disparities among diverse populations., Methods: We conducted an ethnographic analysis of study documents including summaries of patient advisory committee meetings and interviews, reflective field notes written by study team members, and correspondence with our institutional review board (IRB). Through this analysis, we identified cross-cutting challenges for incorporating stakeholder feedback into development of our recruitment, risk assessment, and informed consent processes and materials., Results: Our analysis revealed three key challenges: (1) balancing precision and simplicity in the design of study materials, (2) providing clinical care within the research context, and (3) emphasizing potential study benefits versus risks and limitations., Conclusions: While involving patient stakeholders in study design and materials development can increase inclusivity and responsiveness to patient needs, patient feedback may conflict with that of content area experts on the research team and IRBs who are tasked with overseeing the research. Our analysis highlights the need for further empirical research about ethical challenges when incorporating patient feedback into study design, and for dialogue with genomic researchers and IRB representatives about these issues.

Purpose: As new genetic services become available, their implementation in safety-net settings must be studied., Methods: We interviewed stakeholders (patients and primary care clinicians) from federally qualified health centers to discuss the utility, acceptability, and priority of new genetic services. We presented scenarios tailored for each audience describing carrier testing, diagnostic testing for a developmental delay, and hereditary cancer syndrome testing. We summarized transcripts using the framework method and compared patient and clinician perspectives., Results: Clinicians questioned the relevance and priority of genetic services. Hereditary cancer testing was perceived most favorably by clinicians, who focused on actionability, cost, and access to downstream care. Patients stated that access to genetic services was important and that there should be parity across safety-net and higher-resourced settings., Conclusions: Genetic services with clear clinical impact are more acceptable to clinicians in safety-net clinics. Clinicians may be underestimating patients' interest in expanded genetic services.

Purpose: Our objective was to describe differences in treatment patterns and survival between early-onset (< 50 years old) and late-onset colorectal cancer (CRC) patients in community-based health systems., Methods: We used tumor registry and electronic health record data to identify and characterize patients diagnosed with adenocarcinoma of the colon or rectum from 2010 to 2014 at six US health systems in the patient outcomes to advance learning (PORTAL) network. We used logistic regression to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) comparing the distribution of tumor characteristics and treatment patterns in early-onset versus late-onset CRC. Cox regression models were used to estimate adjusted hazard ratios (HRs) and CIs comparing survival between early- and late-onset CRC patients., Results: There were 1,424 early-onset and 10,810 late-onset CRC cases in our analyses. Compared to late-onset CRC, early-onset CRC was significantly associated with advanced-stage disease, high-grade histology, signet ring histology, and rectal or left colon location. After adjusting for differences in tumor and patient characteristics, early-onset patients were more likely than late-onset patients to have > 12 lymph nodes examined (OR 1.60, CI 1.37-1.87), to receive systemic therapy (chemotherapy or immunotherapy) within 6 months of diagnosis (OR 2.84, CI 2.40-3.37), and to have a reduced risk of CRC-specific death (HR 0.66, CI 0.56-0.79)., Conclusions: Early-onset CRC is associated with aggressive tumor characteristics, distal location, and systemic therapy use. Despite some adverse risk factors, these patients tend to have better survival than older onset patients.

Purpose: Clinical sequencing emerging in health care may result in secondary findings (SFs)., Methods: Seventy-four of 6240 (1.2%) participants who underwent genome or exome sequencing through the Clinical Sequencing Exploratory Research (CSER) Consortium received one or more SFs from the original American College of Medical Genetics and Genomics (ACMG) recommended 56 gene-condition pair list; we assessed clinical and psychosocial actions., Results: The overall adjusted prevalence of SFs in the ACMG 56 genes across the CSER consortium was 1.7%. Initially 32% of the family histories were positive, and post disclosure, this increased to 48%. The average cost of follow-up medical actions per finding up to a 1-year period was $128 (observed, range: $0-$678) and $421 (recommended, range: $141-$1114). Case reports revealed variability in the frequency of and follow-up on medical recommendations patients received associated with each SF gene-condition pair. Participants did not report adverse psychosocial impact associated with receiving SFs; this was corroborated by 18 participant (or parent) interviews. All interviewed participants shared findings with relatives and reported that relatives did not pursue additional testing or care., Conclusion: Our results suggest that disclosure of SFs shows little to no adverse impact on participants and adds only modestly to near-term health-care costs; additional studies are needed to confirm these findings.

Purpose: Few population-level surveys have explored patient-centered priorities for improving colorectal cancer survivors' care. Working with patients, we designed a survey to identify care improvement and survivorship priorities., Methods: We surveyed a random sample of 4000 patients from a retrospective, population-based cohort of colorectal cancer survivors diagnosed during 2010-2014. The survey included two multiple response questions: "What would you have changed about your cancer diagnosis and treatment experience?" and "What are your biggest health or lifestyle concerns (other than having cancer) since being diagnosed?" Multivariable regression identified characteristics associated with endorsement of health care experience and survivorship concerns., Results: Survey response rate was 50.2% (2000/3986). Fifty-three percent reported at least one unmet need, most commonly for more information about life after treatment (26.7%). Survivors of rectal cancer reported more needs than respondents with colon cancer; persons of color reported more needs than non-Hispanic whites; individuals without high school diplomas reported more needs than individuals with more education. Fear of recurrence was the most common health/lifestyle concern (58.9%). Respondents under age 65 reported nearly all health/lifestyle concerns more often than respondents over age 74. Rectal cancer survivors reported more concerns about activity limitation, changes, and body function and appearance than colon cancer survivors. Persons of color were more likely to report financial concerns than non-Hispanic whites., Conclusions: The greatest needs for intervention are among survivors of rectal cancer, survivors of minority racial/ethnic background, and survivors of younger age. Survivors with low educational attainment and those with higher stage disease could also benefit.

Purpose: Complex bladder and colorectal cancer surgeries are associated with significant patient morbidity, yet few resources exist to prepare patients for the high levels of distress and complications they may experience. After ethnographic research to identify design challenges, we held a user-centered design (UCD) workshop to begin to develop patient- and caregiver-centered interventions to support preparation for and recovery after complex cancer surgery., Methods: Concepts that emerged from brainstorming sessions were visually represented on storyboards and rated. Highly scored concepts were further developed in break-out prototyping sessions and then presented to the entire group for review in person and during subsequent webinars. We collected workshop products (worksheets, prototypes, and recordings) for analysis to identify opportunities for intervention. The workshop, held in late 2014, was attended by three colorectal/oncologic surgeons, three urologic surgeons, five ostomy nurses, one quality improvement leader, three patients, one caregiver, and three experienced UCD facilitators., Results: Three opportunity areas were identified: (1) enhanced patient education including tele-health and multi-media tools (available at hospitals/clinics or online in any setting), (2) personalized discharge assessment and care planning, and (3) integrated symptom monitoring and educational interventions. Stakeholders reached consensus that enhanced patient education was the most important direction for subsequent intervention development., Conclusions: We engaged diverse stakeholders in a participatory, UCD process and concluded that research and practice improvement should prioritize the development of educational interventions in the pre-operative period to set the groundwork for improving appropriate self-care during recovery from major colorectal and bladder cancer surgeries.

Purpose: Surgical treatment for rectal cancer (RC) can result in an intestinal ostomy that requires lifelong adaptation and investment of physical, cognitive, and financial resources. However, little is known about the extent of ongoing challenges related to ostomy self-care among long-term RC survivors. We analyzed the prevalence of self-reported ostomy self-care challenges and the physical and environmental factors that can support or undermine ostomy self-care., Methods: We mailed surveys to long-term (≥ 5 years post-diagnosis) RC survivors, including 177 adults with ostomies who were members of integrated health systems in northern California, Oregon, and Washington State. Potential participants were identified through tumor registries. Data were also extracted from electronic health records., Results: The response rate was 65%. The majority of respondents were male (67%), and the mean age was 75 years. Sixty-three percent of respondents reported at least one ostomy self-care challenge. The most common challenges were leakage or skin problems around the ostomy and needing to change the pouching system too frequently. Twenty-two percent reported difficulty caring for their ostomy. Younger age and higher BMI were consistently related to ostomy self-care challenges., Conclusions: The majority of RC survivors reported ostomy-related self-care challenges, and 31% experienced problems across multiple domains of ostomy self-care. In addition, most survivors reported significant physical challenges that could lead to ostomy-related disability. Although the participants surveyed had access to ostomy care nurses, the care gaps we found suggest that additional work is needed to understand barriers to ostomy care, reduce unmet needs, and improve well-being among this group.

Advances in technology and the promise of personalized health care are driving greater use of genome sequencing (GS) for a variety of clinical scenarios. As health systems consider adopting GS, they need to understand the impact of GS on the organization and cost of care. While research has documented a dramatic decrease in the cost of sequencing and interpreting GS, few studies have examined how GS impacts genetic counseling workloads. This study examined the time needed to provide genetic counseling for GS in the context of preconception carrier screening. Genetic counselors prospectively reported on the time spent in the results disclosure process with 107 study participants who were part of the NextGen study. We found that the median time for results disclosure was 64 min (ranged from 5 to 229 min). Preparation work was the most time-consuming activity. Qualitative data from journal entries, debrief interviews with genetic counselors, and detailed case conference notes provided information on factors influencing time for results disclosure and implications for practice. Results suggest that expanded carrier screening could require significant increases in genetic counseling time, unless we are able to generate new resources to reduce preparation work or develop other strategies such as the creation of new models to deliver this type of service.

Background: Young adulthood is often associated with poor dietary habits that may increase risk of obesity and chronic diseases. As independence grows, little is known about strategies to help balance social, work, and education commitments that may override desires to incorporate healthful food choices., Objective: In advance of a randomized trial to test an online intervention targeting young adults, we sought to identify views and experiences with healthy eating, and specifically, eating more fruits and vegetables., Methods: We conducted 13 focus groups with 68 young adults in metropolitan Detroit (Henry Ford Health System) and rural Pennsylvania (Geisinger Health System). Randomly selected adults aged 21 to 30 years, using health system automated data, were sent recruitment letters. Questions were grounded in social cognitive theory and self-determination theory. Audiotapes were transcribed, content themes identified, coded, verified for reliability, and analyzed qualitatively., Results: Young adults' efforts to eat healthfully included three major themes of (1) motivations to create a healthy lifestyle, teach by example, feel better, and manage weight and future health problems; (2) learning to eat well from childhood, independent living, and peers; and (3) strategies to eat better through planning, tracking, and commitment., Discussion: We uncovered theory-based factors that facilitate healthy dietary behavior change among young adults, including managing their behavior through self-monitoring, goal-setting, small steps, meaningful reinforcements, and social opportunities., Conclusions: Targeted interventions encouraging reflection on personal values related to meaningful contemporary health benefits are likely to resonate with young adults, as will opportunities to receive and share new information.

As expanded genome-scale carrier screening becomes increasingly prevalent, patients will face decisions about whether to receive results about a vast number of genetic conditions. Understanding patient preferences is important to meaningfully demonstrate the ethical goal of respect and support patient autonomy. We explore one possible way to elicit preferences by sorting conditions into categories, which may support patient decision making, but the extent to which categories are helpful is unknown. In the context of a randomized trial of genome sequencing for preconception carrier screening compared to usual care (single disease carrier testing), we interviewed 41 participants who had genome sequencing about their experience using a taxonomy of conditions to select categories of results to receive. We then conducted interviews with an additional 10 participants who were not randomized to genome sequencing, asking them about the taxonomy, their reasons for selecting categories, and alternative ways of presenting information about potential results to receive. Participants in both groups found the categories helpful and valued having a meaningful opportunity to choose which results to receive, regardless of whether they opted to receive all or only certain categories of results. Additionally, participants who received usual care highlighted preparedness as a primary motivation for receiving results, and they indicated that being presented with possible reasons for receiving or declining results for each category could be helpful. Our findings can be used to develop approaches, including the use of categories, to support patient choices in expanded carrier screening. Further research should evaluate and optimize these approaches., (© 2017 Wiley Periodicals, Inc.)

Background: Bowel function in long-term rectal cancer survivors with anastomosis has not been characterized adequately. We hypothesized that bowel function is associated with patient, disease, and treatment characteristics., Methods: The cohort study included Kaiser Permanente members who were long-term (≥5 years) rectal cancer survivors with anastomosis. Bowel function was scored using the self-administered, 14-item Memorial Sloan-Kettering Cancer Center Bowel Function Index. Patient, cancer, and treatment variables were collected from the electronic medical chart. We used multiple regression to assess the relationship of patient- and treatment-related variables with the bowel function score., Results: The study included 381 anastomosis patients surveyed an average 12 years after their rectal cancer surgeries. The total bowel function score averaged 53 (standard deviation, 9; range, 31-70, higher scores represent better function). Independent factors associated with worse total bowel function score included receipt of radiation therapy (yes vs. no: 5.3-unit decrement, p < 0.0001), tumor distance from the anal verge (≤6 cm vs. >6 cm: 3.2-unit decrement, p < 0.01), and history of a temporary ostomy (yes vs. no: 4.0-unit decrement, p < 0.01). One factor measured at time of survey was also associated with worse total bowel function score: ever smoking (2.3-unit decrement, p < 0.05). The regression model explained 20% of the variation in the total bowel function score., Conclusions: Low tumor location, radiation therapy, temporary ostomy during initial treatment, and history of smoking were linked with decreased long-term bowel function following an anastomosis. These results should improve decision-making about surgical options.

Genomic carrier screening can identify more disease-associated variants than existing carrier screening methodologies, but its utility from patients' perspective is not yet established. A randomized controlled trial for preconception genomic carrier screening provided an opportunity to understand patients' decisions about whether to accept or decline testing. We administered a survey to potential genomic carrier screening recipients who declined participation (N = 240) to evaluate their reasons for doing so. Two thirds of women declined participation. We identified major themes describing reasons these individuals declined to participate; the most common were time limitation, lack of interest, not wanting to know the information, and potential cause of worry or anxiety. Most women eligible for genomic carrier screening indicated that their reasons for opting out were due to logistical issues rather than opposing the rationale for testing. As expanded carrier screening and genomic sequencing become a more routine part of clinical care, it is anticipated there will be variable uptake from individuals for this testing. Thus, the advancement of clinical carrier screening from single genes, to expanded screening panels, to an exome- or genome-wide platform, will require approaches that respect individual choice to receive genetic testing for reproductive risk assessment.

Purpose: The goal of this study was to determine response rates and associated costs of different survey methods among colorectal cancer (CRC) survivors., Methods: We assembled a cohort of 16,212 individuals diagnosed with CRC (2010-2014) from six health plans, and randomly selected 4000 survivors to test survey response rates across four mixed-mode survey administration protocols (in English and Spanish): arm 1, mailed survey with phone follow-up; arm 2, interactive voice response (IVR) followed by mail; arm 3; email linked to web-based survey with mail follow-up; and arm 4, email linked to web-based survey followed by IVR., Results: Our overall response rate was 50.2%. Arm 1 had the highest response rate (59.9%), followed by arm 3 (51.9%), arm 2 (51.2%), and arm 4 (37.9%). Response rates were higher among non-Hispanic whites in all arms than other racial/ethnic groups (p < 0.001), among English (51.5%) than Spanish speakers (36.4%) (p < 0.001), and among higher (53.7%) than lower (41.4%) socioeconomic status (p < 0.001). Survey arms were roughly comparable in cost, with a difference of only 8% of total costs between the most (arm 2) and least (arm 3) expensive arms., Conclusions: Mailed surveys followed by phone calls achieved the highest response rate; email invitations and online surveys cost less per response. Electronic methods, even among those with email availability, may miss important populations including Hispanics, non-English speakers, and those of lower socioeconomic status., Implications for Cancer Survivors: Our results demonstrate effective methods for capturing patient-reported outcomes, inform the relative benefits/disadvantages of the different methods, and identify future research directions.

As genome or exome sequencing (hereafter genome-scale sequencing) becomes more integrated into standard care, carrier testing is an important possible application. Carrier testing using genome-scale sequencing can identify a large number of conditions, but choosing which conditions/genes to evaluate as well as which results to disclose can be complicated. Carrier testing generally occurs in the context of reproductive decision-making and involves patient values in a way that other types of genetic testing may not. The Kaiser Permanente Clinical Sequencing Exploratory Research program is conducting a randomized clinical trial of preconception carrier testing that allows participants to select their preferences for results from among broad descriptive categories rather than selecting individual conditions. This paper describes (1) the criteria developed by the research team, the return of results committee (RORC), and stakeholders for defining the categories; (2) the process of refining the categories based on input from patient focus groups and validation through a patient survey; and (3) how the RORC then assigned specific gene-condition pairs to taxonomy categories being piloted in the trial. The development of four categories (serious, moderate/mild, unpredictable, late onset) for sharing results allows patients to select results based on their values without separately deciding their interest in knowing their carrier status for hundreds of conditions. A fifth category, lifespan limiting, was always shared. The lessons learned may be applicable in other results disclosure situations, such as incidental findings., (© 2016 Wiley Periodicals, Inc.)

Advances in genome sequencing and gene discovery have created opportunities to efficiently assess more genetic conditions than ever before. Given the large number of conditions that can be screened, the implementation of expanded carrier screening using genome sequencing will require practical methods of simplifying decisions about the conditions for which patients want to be screened. One method to simplify decision making is to generate a taxonomy based on expert judgment. However, expert perceptions of condition attributes used to classify these conditions may differ from those used by patients. To understand whether expert and patient perceptions differ, we asked women who had received preconception genetic carrier screening in the last 3 years to fill out a survey to rate the attributes (predictability, controllability, visibility, and severity) of several autosomal recessive or X-linked genetic conditions. These conditions were classified into one of five taxonomy categories developed by subject experts (significantly shortened lifespan, serious medical problems, mild medical problems, unpredictable medical outcomes, and adult-onset conditions). A total of 193 women provided 739 usable ratings across 20 conditions. The mean ratings and correlations demonstrated that participants made distinctions across both attributes and categories. Aggregated mean attribute ratings across categories demonstrated logical consistency between the key features of each attribute and category, although participants perceived little difference between the mild and serious categories. This study provides empirical evidence for the validity of our proposed taxonomy, which will simplify patient decisions for results they would like to receive from preconception carrier screening via genome sequencing., (© 2016 Wiley Periodicals, Inc.)

As genome sequencing technology advances, research is needed to guide decision-making about what results can or should be offered to patients in different clinical settings. We conducted three focus groups with individuals who had prior preconception genetic testing experience to explore perceived advantages and disadvantages of genome sequencing for preconception carrier screening, compared to usual care. Using a discussion guide, a trained qualitative moderator facilitated the audio-recorded focus groups. Sixteen individuals participated. Thematic analysis of transcripts started with a grounded approach and subsequently focused on participants' perceptions of the value of genetic information. Analysis uncovered two orientations toward genomic preconception carrier screening: "certain" individuals desiring all possible screening information; and "hesitant" individuals who were more cautious about its value. Participants revealed valuable information about barriers to screening: fear/anxiety about results; concerns about the method of returning results; concerns about screening necessity; and concerns about partner participation. All participants recommended offering choice to patients to enhance the value of screening and reduce barriers. Overall, two groups of likely users of genome sequencing for preconception carrier screening demonstrated different perceptions of the advantages or disadvantages of screening, suggesting tailored approaches to education, consent, and counseling may be warranted with each group.

Background: Bowel dysfunction is a known complication of colorectal cancer (CRC) surgery. Poor bowel control has a detrimental impact on survivors' health-related quality of life (HRQOL). This analysis describes the dietary and behavioral adjustments used by CRC survivors to manage bowel dysfunction and compares adjustments used by survivors with permanent ostomy to those with anastomosis., Methods: This mixed-methods analysis included pooled data from several studies that assessed HRQOL in CRC survivors. In all studies, CRC survivors with or without permanent ostomies (N = 856) were surveyed using the City of Hope Quality of Life Colorectal Cancer tool. Dietary adjustments were compared by ostomy status and by overall HRQOL score (high vs. low). Qualitative data from 13 focus groups and 30 interviews were analyzed to explore specific strategies used by survivors to manage bowel dysfunction., Results: CRC survivors made substantial, permanent dietary, and behavioral adjustments after surgery, regardless of ostomy status. Survivors who took longer after surgery to become comfortable with their diet or regain their appetite were more likely to report worse HRQOL. Adjustments to control bowel function were divided into four major strategies: dietary adjustments, behavioral adjustments, exercise, and medication use., Conclusions: CRC survivors struggled with unpredictable bowel function and may fail to find a set of management strategies to achieve regularity. Understanding the myriad adjustments used by CRC survivors may lead to evidence-based interventions to foster positive adjustments after surgery and through long-term survivorship.

Purpose: Pharmacists' satisfaction with a computerized prescriber order-entry (CPOE) system and the impact of CPOE on pharmacy workflows and order verification were investigated., Summary: A mixed-method study was conducted to evaluate the implementation of a CPOE system in three hospitals of a large Michigan-based health system and early user experience with the system. Surveys of pharmacists before (n = 54) and after (n = 42) CPOE implementation indicated that they held generally positive expectations about CPOE prior to and during system implementation and continued to hold positive views about CPOE after several months of system use. In interviews and focus group discussions, pharmacists reported a number of important CPOE benefits, but they also cited challenges related to CPOE provider alerts, uncertainty about medication timing, and the need to support providers by serving as informal CPOE system trainers. Direct observation of pharmacists before and after CPOE implementation indicated decreases in both the rate of order clarification events (from 0.89 to 0.35 per hour, p < 0.001) and the average time spent per hour clarifying orders (from 4.75 to 2.11 minutes, p = 0.008)., Conclusion: Several months after CPOE implementation, pharmacists indicated that several aspects of their workload had improved, including the process of medication order clarification, their ability to prioritize work, and their ability to move around within the hospital to respond to demand. However, pharmacists also noted that order ambiguity still existed and that the system needed to be optimized to gain efficiencies and increase clarity., (Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.)

Purpose: While the burdens and rewards of cancer caregiving are well-documented, few studies describe the activities involved in cancer caregiving. We employed a social-ecological perspective to explore the work of cancer caregiving for long-term colorectal cancer (CRC) survivors with ostomies. We focused on healthcare management, defined here as the ways in which informal caregivers participate in healthcare-related activities such as managing medical appointments and information, obtaining prescriptions and supplies, and providing transportation to obtain healthcare services., Methods: This ethnographic study included 31 dyads consisting of long-term CRC survivors (>5 years postsurgery) and their primary informal caregivers. Survivors were members of integrated healthcare delivery systems. We interviewed participants using in-depth interviews and followed a subset using ethnographic methods. Medical record data ascertained survivors' cancer and medical history., Results: We classified families into a matrix of healthcare management resources (high vs. low) and survivors' healthcare needs (high vs. low). We found that patients' healthcare needs did not always correspond to their caregivers' management activities. CRC survivors with high needs had more unmet needs when caregivers and survivors differed in the level of caregiver involvement they desired or regarded as optimal. This discrepancy was particularly evident in nonmarital relationships., Conclusions: As cancer survivors age and grow in number, it becomes increasingly important to understand how informal caregivers support survivors' well-being. Framing healthcare management as a component of caregiving provides a useful perspective that could facilitate future research and interventions to support survivors, particularly those with significant sequelae from their cancer treatment.

Colorectal cancer (CRC) is the third most common cancer in the United States. For some CRC patients, cancer treatment involves creating a permanent or temporary intestinal ostomy. Having an ostomy often results in complex social and physical concerns-including unpredictable and at times publicly noticeable bowel output. In this article, we discuss findings from 30 in-depth interviews with female CRC survivors with ostomies in the western United States. We highlight how having an ostomy disrupts culturally sanctioned practices of continence that mark the attainment of full-adult personhood. We discuss how survivors reclaim a sense of full personhood after ostomy surgery through a process of realignment that entails both learning how to manage ostomy equipment to conceal bowel activity and reappraising their illness and suffering. We suggest that the anthropological categories of personhood and personhood realignment be incorporated into research and interventions aimed at increasing support among cancer survivors living with bodily impairments., (© 2014 by the American Anthropological Association.)

Purpose: The purpose of this article was to describe persistent ostomy-specific concerns and adaptations in long-term (>5 years) colorectal cancer survivors with ostomies., Subjects and Settings: Thirty-three colorectal cancer survivors who participated in 8 gender- and health-related quality of life stratified focus groups and 130 colorectal cancer survivors who provided written comments to 2 open-ended questions on ostomy location and pouch problems participated in the study. Data were collected on health maintenance organization members in Oregon, southwestern Washington, and northern California., Methods: Qualitative data were analyzed for the 8 focus groups and written comments from 2 open-ended survey questions. Discussions from the focu s groups were recorded, transcribed, and analyzed using content analysis. Written content from the open-ended questions was derived from a mailed questionnaire on health-related quality of life in survivors with ostomies and analyzed using content analysis., Results: Discussions related to persistent ostomy-related issues more than 5 years after formation were common. Persistent ostomy-related issues were focused on clothing restrictions and adaptations, dietary concerns, issues related to ostomy equipment and self-care, and the constant need to find solutions to adjust and readjust to living with an ostomy., Conclusions: Ostomy-specific concerns persist 5 years and more for long-term colorectal cancer survivors after initial ostomy formation. Adaptations tend to be individualized and based on trial and error. Findings underscore the need to develop long-term support mechanisms that survivors can access to promote better coping and adjustment to living with an ostomy.

In prior work, using a Rapid Assessment Process (RAP), we have investigated clinical decision support (CDS) in ambulatory clinics and hospitals. We realized that individuals in these settings provide only one perspective related to the CDS landscape, which also includes content vendors and electronic health record (EHR) vendors. To discover content vendors' perspectives and their perceived challenges, we modified RAP for industrial settings. We describe how we employed RAP, and show its utility by describing two illustrative themes. We found that while the content vendors believe they provide unique much-needed services, the amount of labor involved in content development is underestimated by others. We also found that the content vendors believe their products are resources to be used by practitioners, so they are somewhat protected from liability issues. To promote adequate understanding about these issues, we recommend a "three way conversation" among content vendors, EHR vendors, and user organizations.

Clinical Decision Support (CDS) is viewed as a means to improve safety and efficiency in health care. Yet the lack of consensus about what is meant by CDS represents a barrier to effective design, implementation, and utilization of CDS tools. We conducted a multi-site qualitative inquiry to understand how different people define and describe CDS. Using subjects' multiple perspectives we were able to gain new insights as to what stakeholders want CDS to achieve and how to achieve it even when those perspectives are competing and conflicting.