Family Caregiver Comfort with Telehealth Technologies: Differences by Race and Ethnicity in a Cross-Sectional Survey.

Background: Telehealth has seen widespread use since the onset of the COVID-19 pandemic, and 82% patients required assistance in accessing their telehealth appointments. This assistance commonly comes from a family caregiver who may or may not be comfortable using the technologies associated with telehealth. The objective of our study was to analyze a demographically representative survey of U.S. family caregivers to understand the level of comfort using telehealth technologies among family caregivers. Methods: A secondary analysis of survey data collected during the COVID-19 pandemic in 2020. Level of caregiver comfort using computers, smartphones, and tablets was determined through three Likert-style questions. Proportional odds logistic regression was used to understand the associations between demographic variables and level of caregiver comfort using each technology, when adjusting for covariates. Results: A total of 340 caregivers were included in the analysis. Compared with non-Hispanic white caregivers, Asian caregivers had higher odds (odds ratio [OR] 3.14; 95% confidence interval [CI] 1.36, 8.02; p = 0.01) of expressing comfort using computers; black caregivers (OR 0.46; 95% CI 0.21, 0.98; p = 0.04) and Hispanic caregivers (OR 0.36; 95% CI 0.17, 0.79; p = 0.01) expressed lower odds of comfort using smartphones; and Asian caregivers had higher odds (OR 4.64; 95% CI 2.05, 11.69; p = 0.001) of expressing comfort using tablets. Conclusion and Implications: There are identified disparities in the level of technological comfort using computers, smartphones, and tablets by different racial and ethnic groups. Health systems should consider early stakeholder involvement in the design of telehealth technologies, culturally responsive training materials on telehealth technology use to reduce disparities in comfort using telehealth technologies.

Evaluating Physician Emotion Regulation in Serious Illness Conversations Using Multimodal Assessment.

CONTEXT: Emotion regulation by the physician can influence the effectiveness of serious illness conversations. The feasibility of multimodal assessment of emotion regulation during these conversations is unknown. OBJECTIVES: To develop and assess an experimental framework for evaluating physician emotion regulation during serious illness conversations. METHODS: We developed and then assessed a multimodal assessment framework for physician emotion regulation using a cross-sectional, pilot study on physicians trained in the Serious Illness Conversation Guide (SICG) in a simulated, telehealth encounter. Development of the assessment framework included a literature review and subject matter expert consultations. Our predefined feasibility endpoints included: an enrollment rate of ≥60% of approached physicians, >90% completion rate of survey items, and <20% missing data from wearable heart rate sensors. To describe physician emotion regulation, we performed a thematic analysis of the conversation, its documentation, and physician interviews. RESULTS: Out of 12 physicians approached, 11 (92%) SICG-trained physicians enrolled in the study: five medical oncology and six palliative care physicians. All 11 completed the survey (100% completion rate). Two sensors (chest band, wrist sensor) had <20% missing data during study tasks. The forearm sensor had >20% missing data. The thematic analysis found that physicians': 1) overarching goal was to move beyond prognosis to reasonable hope; 2) tactically focused on establishing a trusting, supportive relationship; and 3) possessed incomplete awareness of their emotion regulation strategies. CONCLUSION: Our novel, multimodal assessment of physician emotion regulation was feasible in a simulated SICG encounter. Physicians exhibited an incomplete understanding of their emotion regulation strategies.

Relevance of Bone Marrow Biopsies for Response Assessment in US National Cancer Institute National Clinical Trials Network Follicular Lymphoma Clinical Trials.

PURPOSE: Bone marrow biopsies (BMB) are performed before/after therapy to confirm complete response (CR) in patients with lymphoma on clinical trials. We sought to establish whether BMB add value in assessing response or predict progression-free survival (PFS) or overall survival (OS) outcomes in follicular lymphoma (FL) subjects in a large, multicenter, multitrial cohort. METHODS: Data were pooled from seven trials of 580 subjects with previously untreated FL through Alliance for Clinical Trials in Oncology (Alliance) and SWOG Cancer Research Network (SWOG) completing enrollment from 2008 to 2016. RESULTS: Only 5/580 (0.9%) had positive baseline BMB, CR on imaging, and subsequent positive BMB (P < .0001). Therefore, BMB were irrelevant to response in 99% of subjects. A sensitivity analysis of 385 FL subjects treated on an Eastern Cooperative Oncology Group study was included. In the Eastern Cooperative Oncology Group cohort, 5/385 (1.3%) had BMB that affected response assessment. Since some subjects do not undergo confirmatory BMB, we performed a landmark survival analysis from first radiologic CR with data from 580 subjects from Alliance and SWOG. Of subjects with CR on imaging (n = 187), PFS and OS were not significantly different among those with negative BMB to confirm CR (n = 47) versus those without repeat BMB (n = 140; PFS: adjusted hazard ratio, 1.10, 95% CI, 0.62 to 1.94, log-rank P = .686; OS: hazard ratio, 0.59, 95% CI, 0.23 to 1.53, log-rank P = .276). CONCLUSION: We conclude that BMB add little value to response assessment in subjects with FL treated on clinical trials and we recommend eliminating BMB from clinical trial requirements. BMB should also be removed from diagnostic guidelines for FL except in scenarios in which it may change management including confirmation of limited stage and assessment of cytopenias. This would reduce cost, patient discomfort, resource utilization, and potentially remove a barrier to trial enrollment.

Guidelines to Establish an Equitable Mobile Health Ecosystem.

Mobile health (mHealth)-that is, use of mobile devices, such as mobile phones, monitoring devices, personal digital assistants, and other wireless devices, in medical care-is a promising approach to the provision of support services. mHealth may aid in facilitating monitoring of mental health conditions, offering peer support, providing psychoeducation (i.e., information about mental health conditions), and delivering evidence-based practices. However, some groups may fail to benefit from mHealth despite a high need for mental health services, including people from racially and ethnically disadvantaged groups, rural residents, individuals who are socioeconomically disadvantaged, and people with disabilities. A well-designed mHealth ecosystem that considers multiple elements of design, development, and implementation can afford disadvantaged populations the opportunity to address inequities and facilitate access to and uptake of mHealth. This article proposes inclusion of the following principles and standards in the development of an mHealth ecosystem of equity: use a human-centered design, reduce bias in machine-learning analytical techniques, promote inclusivity via mHealth design features, facilitate informed decision making in technology selection, embrace adaptive technology, promote digital literacy through mHealth by teaching patients how to use the technology, and facilitate access to mHealth to improve health outcomes.

Digitally filling the access gap in mental health care: An investigation of the association between rurality and online engagement with validated self-report screens across the United States.

Mental health disorders are highly prevalent, yet few persons receive access to treatment; this is compounded in rural areas where mental health services are limited. The proliferation of online mental health screening tools are considered a key strategy to increase identification, diagnosis, and treatment of mental illness. However, research on real-world effectiveness, especially in hard to reach rural communities, is limited. Accordingly, the current work seeks to test the hypothesis that online screening use is greater in rural communities with limited mental health resources. The study utilized a national, online, population-based cohort consisting of Microsoft Bing search engine users across 18 months in the United States (representing approximately one-third of all internet searches), in conjunction with user-matched data of completed online mental health screens for anxiety, bipolar, depression, and psychosis (N = 4354) through Mental Health America, a leading non-profit mental health organization in the United States. Rank regression modeling was leveraged to characterize U.S. county-level screen completion rates as a function of rurality, health-care availability, and sociodemographic variables. County-level rurality and mental health care availability alone explained 42% of the variance in MHA screen completion rate (R2 = 0.42, p < 5.0 × 10-6). The results suggested that online screening was more prominent in underserved rural communities, therefore presenting as important tools with which to bridge mental health-care gaps in rural, resource-deficient areas.

Precision Assessment of COVID-19 Phenotypes Using Large-Scale Clinic Visit Audio Recordings: Harnessing the Power of Patient Voice.

COVID-19 cases are exponentially increasing worldwide; however, its clinical phenotype remains unclear. Natural language processing (NLP) and machine learning approaches may yield key methods to rapidly identify individuals at a high risk of COVID-19 and to understand key symptoms upon clinical manifestation and presentation. Data on such symptoms may not be accurately synthesized into patient records owing to the pressing need to treat patients in overburdened health care settings. In this scenario, clinicians may focus on documenting widely reported symptoms that indicate a confirmed diagnosis of COVID-19, albeit at the expense of infrequently reported symptoms. While NLP solutions can play a key role in generating clinical phenotypes of COVID-19, they are limited by the resulting limitations in data from electronic health records (EHRs). A comprehensive record of clinic visits is required-audio recordings may be the answer. A recording of clinic visits represents a more comprehensive record of patient-reported symptoms. If done at scale, a combination of data from the EHR and recordings of clinic visits can be used to power NLP and machine learning models, thus rapidly generating a clinical phenotype of COVID-19. We propose the generation of a pipeline extending from audio or video recordings of clinic visits to establish a model that factors in clinical symptoms and predict COVID-19 incidence. With vast amounts of available data, we believe that a prediction model can be rapidly developed to promote the accurate screening of individuals at a high risk of COVID-19 and to identify patient characteristics that predict a greater risk of a more severe infection. If clinical encounters are recorded and our NLP model is adequately refined, benchtop virologic findings would be better informed. While clinic visit recordings are not the panacea for this pandemic, they are a low-cost option with many potential benefits, which have recently begun to be explored.

Does the use of patient decision aids lead to cost savings? a systematic review.

OBJECTIVES: To update a previous systematic review to determine if patient decision aid (PDA) interventions generate savings in healthcare settings, and if so, from which perspective (ie, patient, organisation providing care, society). DESIGN: Systematic review. DATA SOURCES: MEDLINE, CINAHL, PsycINFO, Web of Science, Cochrane Library, Embase, Campbell Collaboration Library, EconLit, Business Source Complete, Centre for Reviews and Dissemination: NHS Economic Evaluations Database (NHS EED), Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA) from 15 March 2013 to 25 January 2019. The references of studies that met the eligibility criteria and any publications related to conference abstracts or registered clinical trials were reviewed to increase the sensitivity of the search. ELIGIBILITY CRITERIA: Full and partial economic evaluations with an experimental, quasi-experimental or randomised controlled design were included. The intervention had to satisfy the pre-determined minimum conditions necessary to be defined as a PDA, and (for full evaluations) provide details on the comparator used. DATA EXTRACTION AND SYNTHESIS: All study outcomes and economic data were extracted. The reporting and quality of the economic analyses were independently assessed by two health economists. RESULTS: Of 5066 studies, 22 studies were included, including the 8 studies from the previous review. Twelve studies reported cost-savings (range=US$10 to US$81 156; US dollars in 2020), primarily from the organisational or health system perspective, and 10 studies did not. However, due to the quality of the economic analyses, and the related issues with the interpretative validity of results it would be inappropriate to say that PDAs will generate savings, from any perspective. CONCLUSIONS: It is unclear whether PDAs will generate savings. Greater consensus on what constitutes a PDA and the need to compare them against usual care over a sufficient time horizon to allow valid assessment of costs and outcomes is required. PROSPERO REGISTRATION NUMBER: CRD42019118457.

Assessment of the Efficacy of Therapies Following Venetoclax Discontinuation in CLL Reveals BTK Inhibition as an Effective Strategy.

PURPOSE: Venetoclax-based therapy is a standard-of-care option in first-line and relapsed/refractory chronic lymphocytic leukemia (CLL). Patient management following venetoclax discontinuation remains nonstandard and poorly understood. EXPERIMENTAL DESIGN: To address this, we conducted a large international study to identify a cohort of 326 patients who discontinued venetoclax and have been subsequently treated. Coprimary endpoints were overall response rate (ORR) and progression-free survival for the post-venetoclax treatments stratified by treatment type [Bruton's tyrosine kinase inhibitor (BTKi), PI3K inhibitor (PI3Ki), and cellular therapies]. RESULTS: We identified patients with CLL who discontinued venetoclax in the first-line (4%) and relapsed/refractory settings (96%). Patients received a median of three therapies prior to venetoclax; 40% were BTKi naïve (n = 130), and 81% were idelalisib naïve (n = 263). ORR to BTKi was 84% (n = 44) in BTKi-naïve patients versus 54% (n = 30) in BTKi-exposed patients. We demonstrate therapy selection following venetoclax requires prior novel agent exposure consideration and discontinuation reasons. CONCLUSIONS: For BTKi-naïve patients, selection of covalently binding BTKis results in high ORR and durable remissions. For BTKi-exposed patients, covalent BTK inhibition is not effective in the setting of BTKi resistance. PI3Kis following venetoclax do not appear to result in durable remissions. We conclude that BTKi in naïve or previously responsive patients and cellular therapies following venetoclax may be the most effective strategies.See related commentary by Rogers, p. 3501.

Estimation of an inter-rater intra-class correlation coefficient that overcomes common assumption violations in the assessment of health measurement scales.

BACKGROUND: Intraclass correlation coefficients (ICC) are recommended for the assessment of the reliability of measurement scales. However, the ICC is subject to a variety of statistical assumptions such as normality and stable variance, which are rarely considered in health applications. METHODS: A Bayesian approach using hierarchical regression and variance-function modeling is proposed to estimate the ICC with emphasis on accounting for heterogeneous variances across a measurement scale. As an application, we review the implementation of using an ICC to evaluate the reliability of Observer OPTION5, an instrument which used trained raters to evaluate the level of Shared Decision Making between clinicians and patients. The study used two raters to evaluate recordings of 311 clinical encounters across three studies to evaluate the impact of using a Personal Decision Aid over usual care. We particularly focus on deriving an estimate for the ICC when multiple studies are being considered as part of the data. RESULTS: The results demonstrate that ICC varies substantially across studies and patient-physician encounters within studies. Using the new framework we developed, the study-specific ICCs were estimated to be 0.821, 0.295, and 0.644. If the within- and between-encounter variances were assumed to be the same across studies, the estimated within-study ICC was 0.609. If heteroscedasticity is not properly adjusted for, the within-study ICC estimate was inflated to be as high as 0.640. Finally, if the data were pooled across studies without accounting for the variability between studies then ICC estimates were further inflated by approximately 0.02 while formerly allowing for between study variation in the ICC inflated its estimated value by approximately 0.066 to 0.072 depending on the model. CONCLUSION: We demonstrated that misuse of the ICC statistics under common assumption violations leads to misleading and likely inflated estimates of interrater reliability. A statistical analysis that overcomes these violations by expanding the standard statistical model to account for them leads to estimates that are a better reflection of a measurement scale's reliability while maintaining ease of interpretation. Bayesian methods are particularly well suited to estimating the expanded statistical model.

Evaluating CollaboRATE in a clinical setting: analysis of mode effects on scores, response rates and costs of data collection.

BACKGROUND: Shared decision-making (SDM) has become a policy priority, yet its implementation is not routinely assessed. To address this gap we tested the delivery of CollaboRATE, a 3-item patient reported experience measure of SDM, via multiple survey modes. OBJECTIVE: To assess CollaboRATE response rates and respondent characteristics across different modes of administration, impact of mode and patient characteristics on SDM performance and cost of administration per response in a real-world primary care practice. DESIGN: Observational study design, with repeated assessment of SDM performance using CollaboRATE in a primary care clinic over 15 months of data collection. Different modes of administration were introduced sequentially including paper, patient portal, interactive voice response (IVR) call, text message and tablet computer. PARTICIPANTS: Consecutive patients ≥18 years, or parents/guardians of patients <18 years, visiting participating primary care clinicians. MAIN MEASURES: CollaboRATE assesses three core SDM tasks: (1) explanation about health issues, (2) elicitation of patient preferences and (3) integration of patient preferences into decisions. Responses to each item range from 0 (no effort was made) to 9 (every effort was made). CollaboRATE scores are calculated as the proportion of participants who report a score of nine on each of the three CollaboRATE questions. KEY RESULTS: Scores were sensitive to mode effects: the paper mode had the highest average score (81%) and IVR had the lowest (61%). However, relative clinician performance rankings were stable across the different data collection modes used. Tablet computers administered by research staff had the highest response rate (41%), although this approach was costly. Clinic staff giving paper surveys to patients as they left the clinic had the lowest response rate (12%). CONCLUSIONS: CollaboRATE can be introduced using multiple modes of survey delivery while producing consistent clinician rankings. This may allow routine assessment and benchmarking of clinician and clinic SDM performance.

Outpatient administration of BEAM conditioning prior to autologous stem cell transplantation for lymphoma is safe, feasible, and cost-effective.

High-dose BEAM chemotherapy (BCNU, etoposide, Ara-C, and melphalan) followed by autologous hematopoietic stem cell transplantation is frequently used as consolidative therapy for patients with recurrent or refractory Hodgkin or non-Hodgkin lymphoma. The BEAM regimen has traditionally been administered over 6 days in the hospital, with patients remaining hospitalized until hematologic recovery and clinical stability. In an effort to reduce the length of hospitalization for these patients, our institution has transitioned from inpatient (IP) to outpatient (OP) administration of BEAM conditioning. Here, we report the results of an analysis of the feasibility, cost, complications, and outcomes for the initial group of patients who received OP BEAM compared to a prior cohort of patients who received IP BEAM. Patient and disease characteristics were comparable for the two cohorts, as were engraftment kinetics. Length of hospital stay was reduced by 6 days for the OP cohort (P < 0.001), resulting in a cost savings of more than $17,000 per patient. Fewer complications occurred in the OP cohort, including severe enteritis (P = 0.01), organ toxicities (P = 0.01), and infections (P = 0.04). Overall survival rate up to 3 years posttransplant was better for the OP cohort (P = 0.02), likely due to differences in posttransplant therapies. We conclude that OP administration of BEAM conditioning is safe and may offer significant advantages, including decreased length of hospitalization, reduced costs, decreased risks for severe toxicities and infectious complications, and likely improvement in patient satisfaction and quality of life.

Three practical approaches to POPULATION HEALTH.

Start now, experts advise, with strategies that marry the technical with the personal. Here's a trio of pop health approaches that may hold useful lessons for everyone.

Patients recording clinical encounters: a path to empowerment? Assessment by mixed methods.

OBJECTIVE: To examine the motivations of patients recording clinical encounters, covertly or otherwise, and why some do not wish to record encounters. DESIGN: Mixed-methods analysis of survey data and nested semistructured interviews. SETTING: Survey to UK audience, using social media and radio broadcast. PARTICIPANTS: 168 survey respondents, of whom 161 were 18 years of age or older (130 completions). Of the 56 participants who agreed to be contacted, we included data from 17 interviews. RESULTS: 19 (15%) respondents indicated having secretly recorded a clinical encounter and 14 (11%) were aware of someone who had secretly recorded a clinical encounter. 45 (35%) said they would consider recording secretly and 44 (34%) said they would record after asking permission. Totally, 69% of respondents indicated their desire to record clinical encounters, split equally between wanting to do so covertly or with permission. Thematic analysis of the interviews showed that most patients are motivated by the wish to replay, relisten and share the recording with others. Some are also motivated by the idea of owning a personal record, and its potential use as verification of a poor healthcare experience. The rationale for permission seeking was based on the wish to prioritise a trusting relationship with a health professional. Those who preferred to record covertly described a pre-existing lack of trust, a fear that recording would be denied, and a concern that an affronted clinician would deny them access to future care. There was a general wish that recording should be facilitated. CONCLUSIONS: Patients' prime motivation for recording is to enhance their experience of care, and to share it with others. Patients know that recording challenges the 'ceremonial order of the clinic', and so some decide to act covertly. Patients wanted clearer, more permissive policies to be developed.

Conceptualising patient empowerment: a mixed methods study.

BACKGROUND: In recent years, interventions and health policy programmes have been established to promote patient empowerment, with a particular focus on patients affected by long-term conditions. However, a clear definition of patient empowerment is lacking, making it difficult to assess effectiveness of interventions designed to promote it. The aim in this study was to develop a conceptual map of patient empowerment, including components of patient empowerment and relationships with other constructs such as health literacy, self-management and shared decision-making. METHODS: A mixed methods study was conducted comprising (i) a scoping literature review to identify and map the components underpinning published definitions of patient empowerment (ii) qualitative interviews with key stakeholders (patients, patient representatives, health managers and health service researchers) to further develop the conceptual map. Data were analysed using qualitative methods. A combination of thematic and framework analysis was used to integrate and map themes underpinning published definitions of patient empowerment with the views of key UK stakeholders. RESULTS: The scoping literature review identified 67 articles that included a definition of patient empowerment. A range of diverse definitions of patient empowerment was extracted. Thematic analysis identified key underpinning themes, and these themes were used to develop an initial coding framework for analysis of interview data. 19 semi-structured interviews were conducted with key stakeholders. Transcripts were analysed using the initial coding framework, and findings were used to further develop the conceptual map. The resulting conceptual map describes that patient empowerment can be conceived as a state ranging across a spectrum from low to high levels of patient empowerment, with the level of patient empowerment potentially measurable using a set of indicators. Five key components of the conceptual map were identified: underpinning ethos, moderators, interventions, indicators and outcomes. Relationships with other constructs such as health literacy, self-management and shared decision-making are illustrated in the conceptual map. CONCLUSION: A novel conceptual map of patient empowerment grounded in published definitions of patient empowerment and qualitative interviews with UK stakeholders is described, that may be useful to healthcare providers and researchers designing, implementing and evaluating interventions to promote patient empowerment.

Incentivizing shared decision making in the USA--where are we now?

BACKGROUND: The Affordable Care Act raised significant interest in the process of shared decision making, the role of patient decision aids, and incentivizing their utilization. However, it has not been clear how best to put incentives into practice, and how the implementation of shared decision making and the use of patient decision aids would be measured. Our goal was to review developments and proposals put forward. METHODS: We performed a qualitative document analysis following a pragmatic search of Medline, Google, Google Scholar, Business Source Complete (Ebscohost), and LexisNexis from 2009-2013 using the following key words: "Patient Protection and Affordable Care Act", "Decision Making", "Affordable Care Act", "Shared Decision Making", "measurement", "incentives", and "payment." RESULTS: We observed a lack of clarity about how to measure shared decision making, about how best to reward the use of patient decisions aids, and therefore how best to incentivize the process. Many documents clearly imply that providing and disseminating patient decision aids might be equivalent to shared decision making. However, there is little evidence that these tools, when used by patients in advance of clinical encounters, lead to significant change in patient-provider communication. The assessment of shared decision making for performance management remains challenging. CONCLUSION: Efforts to incentivize shared decision making are at risk of being limited to the promotion of patient decision aids, passing over the opportunity to influence the communication processes between patients and providers.

Assessment of patient empowerment--a systematic review of measures.

BACKGROUND: Patient empowerment has gained considerable importance but uncertainty remains about the best way to define and measure it. The validity of empirical findings depends on the quality of measures used. This systematic review aims to provide an overview of studies assessing psychometric properties of questionnaires purporting to capture patient empowerment, evaluate the methodological quality of these studies and assess the psychometric properties of measures identified. METHODS: Electronic searches in five databases were combined with reference tracking of included articles. Peer-reviewed articles reporting psychometric testing of empowerment measures for adult patients in French, German, English, Portuguese and Spanish were included. Study characteristics, constructs operationalised and psychometric properties were extracted. The quality of study design, methods and reporting was assessed using the COSMIN checklist. The quality of psychometric properties was assessed using Terwee's 2007 criteria. FINDINGS: 30 studies on 19 measures were included. Six measures are generic, while 13 were developed for a specific condition (N=4) or specialty (N=9). Most studies tested measures in English (N=17) or Swedish (N=6). Sample sizes of included studies varied from N=35 to N=8261. A range of patient empowerment constructs was operationalised in included measures. These were classified into four domains: patient states, experiences and capacities; patient actions and behaviours; patient self-determination within the healthcare relationship and patient skills development. Quality assessment revealed several flaws in methodological study quality with COSMIN scores mainly fair or poor. The overall quality of psychometric properties of included measures was intermediate to positive. Certain psychometric properties were not tested for most measures. DISCUSSION: Findings provide a basis from which to develop consensus on a core set of patient empowerment constructs and for further work to develop a (set of) appropriately validated measure(s) to capture this. The methodological quality of psychometric studies could be improved by adhering to published quality criteria.