Caregiver Values and Preferences Related to Surgical Decision-making for Children with Medical Complexity.

OBJECTIVE: To uncover the values and preferences of the caregivers for children with medical complexity (CMC), using the test case of surgical treatment decision-making for pediatric neuromuscular scoliosis (NMS) that will inform the future development of a decision support tool in this population. STUDY DESIGN: We conducted a qualitative study of semi-structured interviews of English- and Spanish-speaking caregivers of children with NMS from two geographically distinct children's hospitals. We used purposive sampling of language and treatment options selected to capture diverse experiences. Analysis was based on grounded theory with synthesized caregiver values and preferences themes. RESULTS: From 47 participants, we completed 41 interviews (9 in Spanish). Caregivers had a mean age of 43.2 years, were mostly White (66%), and had children with a mean age of 15.6. 64% chose surgery. The following values and preferences were important to many caregivers: reducing scoliosis-related pain, minimizing mobility limitations to optimize socio-emotional quality of life, limiting the impact of comorbidities on overall quality of life, information provided by peer support, the uncertainty of outcomes due to underlying comorbidities, and the uncertainty related to the anticipated progression of their child's scoliosis curve. Caregivers experienced immense uncertainty related to treatment outcomes due to their child's comorbidities. CONCLUSIONS: Caregivers of CMC may benefit from decision support that includes both values clarification exercises to help caregivers identify what of the many possible values and preferences are important to them and novel methods to communicate uncertainty in the care of CMC.

A Hexagonal Aim as a Driver of Change for Health Care and Health Insurance Systems.

Policy Points Improving health systems requires simultaneous pursuit of a patient centered approach aligned with the health professional: improving the experience of care, improving the health of populations, reducing per capita costs of care - Triple Aim - and improving the work life of the care providers - Quadruple Aim -. Reinforcing the recently defined Fifth Aim as equity through "health democracy" to represent the wants, needs and responsibility of the population in taking care of their health and their healthcare. Adding a Sixth Aim to take into account the increased health risks due to climate change. CONTEXT: Improving health systems, such as the U.S. or French, requires simultaneous pursuit of a patient centered approach aligned with the health professional: improving the experience of care, improving the health of populations, reducing per capita costs of care - Triple Aim - and improving the work life of the care providers, including clinicians and staff - Quadruple Aim -. While these aims are already ambitious, they may be insufficient when considering the economic, social and environmental challenges to the health of our communities in the near and long term. METHODS: A conceptual framework to provide additional ethical guardrails for health systems. RESULTS: Recently, authors have articulated a Fifth Aim and we propose to add a Sixth Aim to the Quadruple Aim model. These additional aims are meant to account for our growing knowledge around the determinants of health and the challenging processes and structures of governance across a wide range of sectors in society including healthcare. We are strengthening the Fifth Aim defined as equity through "health democracy" to represent the wants, needs and responsibility of the population in taking care of their health and their healthcare. The Sixth Aim is to account for the increase in risk to population health due to climate change as well as the impact our health systems have on the environment. CONCLUSIONS: As social tension and environmental changes seem to continue to impact the structure of our society this "Hexagonal Aim" taken together might provide additional ethical guiderails as we set our healthcare goals.

Predictors of COVID-19 vaccine uptake: an online three-wave survey study of US adults.

BACKGROUND: To effectively promote vaccine uptake, it is important to understand which people are most and least inclined to be vaccinated and why. In this study, we examined predictors of COVID-19 vaccine uptake and reasons for non-vaccination. METHODS: We conducted an online English-language survey study in December-2020, January-2021, and March-2021. A total of 930 US respondents completed all surveys. Multiple logistic regression models were run to test whether the early vaccine eligibility, demographic factors, and psychological factors predict getting at least one dose of a COVID-19 vaccination in January-2021 and in March-2021. RESULTS: The proportion of respondents who received ≥ 1-dose of a COVID-19 vaccine increased from 18% (January) to 67% (March). Older age predicted vaccine uptake in January (OR = 2.02[95%CI = 1.14-3.78], p < .001) and March (10.92[6.76-18.05], p < .001). In January, additional predictors were higher numeracy (1.48[1.20-1.86], p < .001), COVID-19 risk perceptions (1.35[1.03-1.78], p = .029), and believing it is important adults get the COVID-19 vaccine (1.66[1.05-2.66], p = .033). In March, additional predictors of uptake were believing it is important adults get the COVID-19 vaccine (1.63[1.15-2.34], p = .006), prior COVID-19 vaccine intentions (1.37[1.10-1.72], p = .006), and belief in science (0.84[0.72-0.99], p = .041). Concerns about side effects and the development process were the most common reasons for non-vaccination. Unvaccinated respondents with no interest in getting a COVID-19 vaccine were younger (0.27[0.09-0.77], p = .016), held negative views about COVID-19 vaccines for adults (0.15[0.08-0.26], p < .001), had lower trust in healthcare (0.59[0.36-0.95], p = .032), and preferred to watch and wait in clinically ambiguous medical situations (0.66[0.48-0.89], p = .007). CONCLUSIONS: Evidence that attitudes and intentions towards COVID-19 vaccines were important predictors of uptake provides validation for studies using these measures and reinforces the need to develop strategies for addressing safety and development concerns which remain at the forefront of vaccine hesitancy.

Patient Perspectives on a Patient-Facing Tool for Lung Cancer Screening.

BACKGROUND: Individuals with high risk for lung cancer may benefit from lung cancer screening, but there are associated risks as well as benefits. Shared decision-making (SDM) tools with personalized information may provide key support for patients. Understanding patient perspectives on educational tools to facilitate SDM for lung cancer screening may support tool development. AIM: This study aimed to explore patient perspectives related to a SDM tool for lung cancer screening using a qualitative approach. METHODS: We elicited patient perspectives by showing a provider-facing SDM tool. Focus group interviews that ranged in duration from 1.5 to 2 h were conducted with 23 individuals with high risk for lung cancer. Data were interpreted inductively using thematic analysis to identify patients' thoughts on and desires for a patient-facing SDM tool. RESULTS: The findings highlight that patients would like to have educational information related to lung cancer screening. We identified several key themes to be considered in the future development of patient-facing tools: barriers to acceptance, preference against screening and seeking empowerment. One further theme illustrated effects of patient-provider relationship as a limitation to meeting lung cancer screening information needs. Participants also noted several suggestions for the design of technology decision aids. CONCLUSION: These findings suggest that patients desire additional information on lung cancer screening in advance of clinical visits. However, there are several issues that must be considered in the design and development of technology to meet the information needs of patients for lung cancer screening decisions. PATIENT OR PUBLIC CONTRIBUTION: Patients, service users, caregivers or members of the public were not involved in the study design, conduct, analysis or interpretation of the data. However, clinical experts in health communication provided detailed feedback on the study protocol, including the focus group approach. The study findings contribute to a better understanding of patient expectations for lung cancer screening decisions and may inform future development of tools for SDM.

Patient Cognitive Status and Physician Recommendations for Cardiovascular Disease Treatment: Results of Two Nationwide, Randomized Survey Studies.

BACKGROUND: Clinical guidelines recommend that older patients (65+) with mild cognitive impairment (MCI) and early-stage dementia receive similar guideline-concordant care after cardiovascular disease (CVD) events as those with normal cognition (NC). However, older patients with MCI and dementia receive less care for CVD and other conditions than those with NC. Whether physician recommendations for guideline-concordant treatments after two common CVD events, acute myocardial infarction (AMI) and acute ischemic stroke (stroke), differ between older patients with NC, MCI, and early-stage dementia is unknown. OBJECTIVE: To test the influence of patient cognitive status (NC, MCI, early-stage dementia) on physicians' recommendations for guideline-concordant treatments for AMI and stroke. DESIGN: We conducted two parallel, randomized survey studies for AMI and stroke in the US using clinical vignettes where the hypothetical patient's cognitive status was randomized between physicians. PARTICIPANTS: The study included cardiologists, neurologists, and generalists who care for most patients hospitalized for AMI and stroke. MAIN MEASURES: The primary outcome was a composite quality score representing the number of five guideline-concordant treatments physicians recommended for a hypothetical patient after AMI or stroke. KEY RESULTS: 1,031 physicians completed the study (58.5% response rate). Of 1,031 respondents, 980 physicians had complete information. After adjusting for physician factors, physicians recommended similar treatments after AMI and stroke in hypothetical patients with pre-existing MCI (adjusted ratio of expected composite quality score, 0.98 [95% CI, 0.94, 1.02]; P = 0.36) as hypothetical patients with NC. Physicians recommended fewer treatments to hypothetical patients with pre-existing early-stage dementia than to hypothetical patients with NC (adjusted ratio of expected composite quality score, 0.90 [0.86, 0.94]; P < 0.001). CONCLUSION: In these randomized survey studies, physicians recommended fewer guideline-concordant AMI and stroke treatments to hypothetical patients with early-stage dementia than those with NC. We did not find evidence that physicians recommend fewer treatments to hypothetical patients with MCI than those with NC.

Veterans and Nonveterans Coping With Stress During 4 Months of COVID-19.

PURPOSE: Identifying how people have been coping with stress during the COVID-19 pandemic allows us to anticipate how the population may react to similar stressors over time. In this study, we assessed patterns of coping styles among veterans and nonveterans, and stability and change in these strategies at 3 time points during the pandemic. METHODS: Using an online survey platform, we circulated a questionnaire at 3 time points during the period when COVID-19 vaccines became widely available (December 2-27, 2020; January 21-February 6, 2021; and March 8-23, 2021). The questionnaire asked participants about their extent of use of 11 coping strategies, and symptoms of anxiety and depression. RESULTS: A total of 2,085 participants (50.8% veterans) completed the questionnaire at 1 or more time points and 930 participants (62.8% veterans) completed it at all 3 time points. Cluster analysis identified 3 distinct coping styles: adaptive, distressed, and disengaged. Compared with nonveterans, veterans more commonly had adaptive and disengaged coping styles, and less commonly had a distressed coping style. The majority of the cohort (71.3%) changed coping style at least once during the study period. Participants who used the same coping style across all 3 time points reported lower levels of anxiety and depression. CONCLUSIONS: Our data demonstrate a need to better understand the dynamic nature of coping with pandemic-level stressors across time. We did not find patterns of change in coping styles, but our findings point to potential advantages of stability in coping style. It is possible that less adaptive styles that are more stable may be advantageous for mental health. This research has implications for supporting patients dealing with stress in family medicine.

Stakeholder Research Priorities to Promote Implementation of Shared Decision-Making for Lung Cancer Screening: An American Thoracic Society and Veterans Affairs Health Services Research and Development Statement.

Rationale: Shared decision-making (SDM) for lung cancer screening (LCS) is recommended in guidelines and required by Medicare, yet it is seldom achieved in practice. The best approach for implementing SDM for LCS remains unknown, and the 2021 U.S. Preventive Services Task Force calls for implementation research to increase uptake of SDM for LCS. Objectives: To develop a stakeholder-prioritized research agenda and recommended outcomes to advance implementation of SDM for LCS. Methods: The American Thoracic Society and VA Health Services Research and Development Service convened a multistakeholder committee with expertise in SDM, LCS, patient-centered care, and implementation science. During a virtual State of the Art conference, we reviewed evidence and identified research questions to address barriers to implementing SDM for LCS, as well as outcome constructs, which were refined by writing group members. Our committee (n = 34) then ranked research questions and SDM effectiveness outcomes by perceived importance in an online survey. Results: We present our committee's consensus on three topics important to implementing SDM for LCS: 1) foundational principles for the best practice of SDM for LCS; 2) stakeholder rankings of 22 implementation research questions; and 3) recommended outcomes, including Proctor's implementation outcomes and stakeholder rankings of SDM effectiveness outcomes for hybrid implementation-effectiveness studies. Our committee ranked questions that apply innovative implementation approaches to relieve primary care providers of the sole responsibility of SDM for LCS as highest priority. We rated effectiveness constructs that capture the patient experience of SDM as most important. Conclusions: This statement offers a stakeholder-prioritized research agenda and outcomes to advance implementation of SDM for LCS.

Parents' quality of life and health after treatment decision for a fetus with severe congenital heart defect.

PURPOSE: This exploratory study examines differences in parents' quality of life by treatment decision and the child's survival outcome in the context of life-threatening congenital heart disease (CHD). DESIGN AND METHODS: Parents of a fetus or neonate diagnosed with severe CHD enrolled in the observational control group of a clinical trial (NCT04437069) and completed quality of life (i.e., contact with clinicians, social support, partner relationship, state of mind), mental and physical health survey measures. Comparisons were made between parents who chose comfort-directed care or surgery and between those whose child did and did not survive. RESULTS: Parents who chose surgery and their child did not survive reported the most contact with their clinicians. Parents who chose comfort-directed care reported lower social support than parents who chose surgery and their child did not survive as well as poorer state of mind compared to parents who chose surgery. CONCLUSIONS: Some aspects of parents' quality of life differed based on their treatment decision. Parents who choose comfort-directed care are vulnerable to some negative outcomes. PRACTICE IMPLICATIONS: Decision support tools and bereavement resources to assist parents with making and coping with a complex treatment decision is important for clinical care.

Randomized evaluation of decision support interventions for atrial fibrillation: Rationale and design of the RED-AF study.

BACKGROUND: Shared decision making (SDM) improves the likelihood that patients will receive care in a manner consistent with their priorities. To facilitate SDM, decision aids (DA) are commonly used, both to prepare a patient before their clinician visit, as well as to facilitate discussion during the visit. However, the relative efficacy of patient-focused or encounter-based DAs on SDM and patient outcomes remains largely unknown. We aim to directly estimate the comparative effectiveness of two DA's on SDM observed in encounters to discuss stroke prevention strategies in patients with atrial fibrillation (AF). METHODS: The study aims to recruit 1200 adult patients with non-valvular AF who qualify for anticoagulation therapy, and their clinicians who manage stroke prevention strategies, in a 2x2 cluster randomized multi-center trial at six sites. Two DA's were developed as interactive, online, non-linear tools: a patient decision aid (PDA) to be used by patients before the encounter, and an encounter decision aid (EDA) to be used by clinicians with their patients during the encounter. Patients will be randomized to PDA or usual care; clinicians will be randomized to EDA or usual care. RESULTS: Primary outcomes are quality of SDM, patient decision making, and patient knowledge. Secondary outcomes include anticoagulation choice, adherence, and clinical events. CONCLUSION: This trial is the first randomized, head-to-head comparison of the effects of an EDA versus a PDA on SDM. Our results will help to inform future SDM interventions to improve patients' AF outcomes and experiences with stroke prevention strategies.

The Association Between Mild Cognitive Impairment Diagnosis and Patient Treatment Preferences: a Survey of Older Adults.

BACKGROUND: Older patients (65+) with mild cognitive impairment (MCI) receive less guideline-concordant care for cardiovascular disease (CVD) and other conditions than patients with normal cognition (NC). One potential explanation is that patients with MCI want less treatment than patients with NC; however, the treatment preferences of patients with MCI have not been studied. OBJECTIVE: To determine whether patients with MCI have different treatment preferences than patients with NC. DESIGN: Cross-sectional survey conducted at two academic medical centers from February to December 2019 PARTICIPANTS: Dyads of older outpatients with MCI and NC and patient-designated surrogates. MAIN MEASURES: The modified Life-Support Preferences-Predictions Questionnaire score measured patients' preferences for life-sustaining treatment decisions in six health scenarios including stroke and acute myocardial infarction (range, 0-24 treatments rejected with greater scores indicating lower desire for treatment). KEY RESULTS: The survey response rate was 73.4%. Of 136 recruited dyads, 127 (93.4%) completed the survey (66 MCI and 61 NC). The median number of life-sustaining treatments rejected across health scenarios did not differ significantly between patients with MCI and patients with NC (4.5 vs 6.0; P=0.55). Most patients with MCI (80%) and NC (80%) desired life-sustaining treatments in their current health (P=0.99). After adjusting for patient and surrogate factors, the difference in mean counts of rejected treatments between patients with MCI and patients with NC was not statistically significant (adjusted ratio, 1.08, 95% CI, 0.80-1.44; P=0.63). CONCLUSION: We did not find evidence that patients with MCI want less treatment than patients with NC. These findings suggest that other provider and system factors might contribute to patients with MCI getting less guideline-concordant care.

The Quick Dementia Rating System and Its Relationship to Biomarkers of Alzheimer's Disease and Neuropsychological Performance.

INTRODUCTION: The Quick Dementia Rating System (QDRS) is a brief, patient-reported dementia staging tool that has approximated scores on the Clinical Dementia Rating Scale in patients with Alzheimer's disease (AD). However, no studies have examined its relationship with AD-related biomarkers. METHODS: One-hundred twenty-one older adults (intact, amnestic mild cognitive impairment, mild AD) completed the QDRS, and three biomarkers (amyloid deposition via positron emission tomography, hippocampal volume via magnetic resonance imaging, and apolipoprotein [APOE] ε4 status). RESULTS: The Total score on the QDRS was statistically significantly related to all three biomarkers (after controlling for age, education, sex, and race), with greater levels of dementia severity being associated with greater amyloid deposition, smaller hippocampi, and having copies of APOE ε4 allele. DISCUSSION: In participants across the cognitive spectrum, the QDRS showed modest relationships with amyloid deposition, hippocampal volumes, and APOE status. Therefore, the QDRS may offer a cost-effective screening method for clinical trials in AD.

Parents' decision-making for their foetus or neonate with a severe congenital heart defect.

BACKGROUND: Parents who receive a diagnosis of a severe, life-threatening CHD for their foetus or neonate face a complex and stressful decision between termination, palliative care, or surgery. Understanding how parents make this initial treatment decision is critical for developing interventions to improve counselling for these families. METHODS: We conducted focus groups in four academic medical centres across the United States of America with a purposive sample of parents who chose termination, palliative care, or surgery for their foetus or neonate diagnosed with severe CHD. RESULTS: Ten focus groups were conducted with 56 parents (Mage = 34 years; 80% female; 89% White). Results were constructed around three domains: decision-making approaches; values and beliefs; and decision-making challenges. Parents discussed varying approaches to making the decision, ranging from relying on their "gut feeling" to desiring statistics and probabilities. Religious and spiritual beliefs often guided the decision to not terminate the pregnancy. Quality of life was an important consideration, including how each option would impact the child (e.g., pain or discomfort, cognitive and physical abilities) and their family (e.g., care for other children, marriage, and career). Parents reported inconsistent communication of options by clinicians and challenges related to time constraints for making a decision and difficulty in processing information when distressed. CONCLUSION: This study offers important insights that can be used to design interventions to improve decision support and family-centred care in clinical practice.

Interaction between race and prostate cancer treatment benefit in the Veterans Health Administration.

BACKGROUND: Studies have demonstrated that Black men may undergo definitive prostate cancer (CaP) treatment less often than men of other races, but it is unclear whether they are avoiding overtreatment of low-risk disease or experiencing a reduction in appropriate care. The authors' aim was to assess the role of race as it relates to treatment benefit in access to CaP treatment in a single-payer population. METHODS: The authors used the Veterans Health Administration (VHA) Corporate Data Warehouse to perform a retrospective cohort study of veterans diagnosed with low- or intermediate-risk CaP between 2011 and 2017. RESULTS: The authors identified 35,427 men with incident low- or intermediate-risk CaP. When they controlled for covariates, Black men had 1.05 times the odds of receiving treatment in comparison with non-Black men (P < .001), and high-treatment-benefit men had 1.4 times the odds of receiving treatment in comparison with those in the low-treatment-benefit group (P < .001). The interaction of race and treatment benefit was significant, with Black men in the high-treatment-benefit category less likely to receive treatment than non-Black men in the same treatment category (odds ratio, 0.89; P < .001). CONCLUSIONS: Although race does appear to influence the receipt of definitive treatment in the VHA, this relationship varies in the context of the patient's treatment benefit, with Black men receiving less definitive treatment in high-benefit situations. The influence of patient race at high treatment benefit levels invites further investigation into the driving forces behind this persistent disparity in this consequential group.

Factors Associated With Decision Regret Among Patients With Diverticulitis in the Elective Setting.

BACKGROUND: We aimed to identify decision process measures associated with patient decisional regret regarding the decision to pursue elective colectomy or observation for diverticulitis. MATERIALS AND METHODS: This was a single-center cross-sectional survey study. We included adult patients treated for diverticulitis between 2014 and 2019 and excluded patients who required urgent or emergent colectomy. The primary outcome was regret regarding the decision to pursue elective surgery or observation for diverticulitis, measured using the Decision Regret Scale. We used multivariable linear regression to examine hypothesized predictors of decision regret, including decisional conflict (Decision Conflict Scale and its subscales), shared decision-making, and decision role concordance. RESULTS: Of 923 eligible patients, 133 were included in the analysis. Patients had a median of five episodes of diverticulitis (interquartile range 3-8), occurring a median of 2 y (interquartile range 1-3) before survey administration. Thirty-eight patients (29%) underwent elective surgery for diverticulitis. Decision regret (Decision Regret Scale score ≥25) was present in 42 patients (32%). After controlling for surgery, gender, health status, and years since treatment, decision regret was associated with decisional conflict and inversely associated with values clarity, decision role concordance, shared decision-making, and feeling informed, supported, and effective in decision-making (all P < 0.001). CONCLUSIONS: Nearly one-third of survey respondents experienced regret regarding the decision between elective surgery and observation for diverticulitis. Decision regret may be reduced through efforts to improve patient knowledge, values clarity, role concordance, and shared decision-making.

The CKD Stress Scale: Development and identification of patients at risk.

AIMS: Develop a novel chronic kidney disease (CKD)-specific stress scale and examine associations with patient characteristics. MATERIALS AND METHODS: Adults with CKD stages 1 - 5 enrolled in a cross-sectional survey. Eight questions assessed patients' thoughts and feelings of stress related to CKD (CKD Stress Scale). Patients also reported their knowledge of CKD, barriers to CKD health, and demographics. The scale was evaluated using exploratory factor analysis and Cronbach's alpha. Associations were examined via linear regression. RESULTS: 245 participant enrolled with a mean age of 60 years and a mean estimated glomerular filtration rate (eGFR) of 34 mL/min/1.73m2; 49% were women (match percentage in Table 1), 74% White, 14% African American. A one-factor model of CKD Stress exhibited high internal consistency (α = 0.89). In bivariate analyses, higher CKD Stress was associated with lower eGFR, younger age, African American race (compared to White), and having a high school education or some college (compared to college degree or higher). Adjusting for these characteristics, as well as income and knowledge about CKD, only lower eGFR (b = -0.01; 95% CI [-0.01, -0.001]), younger age (b = -0.01; 95% CI [-0.01, -0.003]), African American race (b = 0.35, 95% CI [0.10, 0.60]), and receiving a high school education or some college (b = 0.20, 95% CI [0.01, 0.39]) were independently associated with more CKD-specific stress. Concurrent validity was supported by associations between stress and perceived barriers to care. CONCLUSION: Our CKD Stress Scale exhibits excellent internal reliability and identified where future educational interventions may benefit from tailoring for at-risk patients.

Gain-loss framing and patients' decisions: a linguistic examination of information framing in physician-patient conversations.

When discussing risks and benefits with cancer patients, physicians could focus on losses such as mortality rates and cancer recurrence or, alternatively, gains such as survival rates and curing cancer. Previous research has shown that the way health information is framed influences individuals' preferences and choices. We operationalized gain-loss framing as physicians' choice of words related to gains (cancer survival), or losses (cancer mortality). In an exploratory analysis, we investigated (a) whether physicians used gain or loss words as a function of their recommendation, (b) whether physicians' choice of words was associated with patients' treatment choices. We analyzed transcribed consultations with male patients who had intermediate-risk prostate cancer. Using an iterative process of gathering and evaluating words, we created gain- and loss-dictionaries. The loss-dictionary included words related to cancer death and cancer progression. The gain-dictionary included words related to survival and cure. Using Linguistic Inquiry and Word Count software, we calculated the number of words related to gains and losses in each transcript. We found that physicians who recommended immediate cancer treatment for prostate cancer (vs. active surveillance) used slightly fewer words related to losses and significantly fewer words related specifically to death from cancer. Further analysis showed that loss words were associated with the patient's choice of immediate cancer treatment. A novel method of automated text analysis showed that physicians' use of loss words was correlated with physicians' recommendations for cancer treatment versus active surveillance. Additionally, loss words in consultations were associated with patients' choice of cancer treatment.

Communicating Scientific Uncertainty About the COVID-19 Pandemic: Online Experimental Study of an Uncertainty-Normalizing Strategy.

BACKGROUND: Communicating scientific uncertainty about public health threats such as COVID-19 is an ethically desirable task endorsed by expert guidelines on crisis communication. However, the communication of scientific uncertainty is challenging because of its potential to promote ambiguity aversion-a well-described syndrome of negative psychological responses consisting of heightened risk perceptions, emotional distress, and decision avoidance. Communication strategies that can inform the public about scientific uncertainty while mitigating ambiguity aversion are a critical unmet need. OBJECTIVE: This study aimed to evaluate whether an "uncertainty-normalizing" communication strategy-aimed at reinforcing the expected nature of scientific uncertainty about the COVID-19 pandemic-can reduce ambiguity aversion, and to compare its effectiveness to conventional public communication strategies aimed at promoting hope and prosocial values. METHODS: In an online factorial experiment conducted from May to June 2020, a national sample of 1497 US adults read one of five versions of an informational message describing the nature, transmission, prevention, and treatment of COVID-19; the versions varied in level of expressed scientific uncertainty and supplemental focus (ie, uncertainty-normalizing, hope-promoting, and prosocial). Participants then completed measures of cognitive, emotional, and behavioral manifestations of ambiguity aversion (ie, perceived likelihood of getting COVID-19, COVID-19 worry, and intentions for COVID-19 risk-reducing behaviors and vaccination). Analyses assessed (1) the extent to which communicating uncertainty produced ambiguity-averse psychological responses; (2) the comparative effectiveness of uncertainty-normalizing, hope-promoting, and prosocial communication strategies in reducing ambiguity-averse responses; and (3) potential moderators of the effects of alternative uncertainty communication strategies. RESULTS: The communication of scientific uncertainty about the COVID-19 pandemic increased perceived likelihood of getting COVID-19 and worry about COVID-19, consistent with ambiguity aversion. However, it did not affect intentions for risk-reducing behaviors or vaccination. The uncertainty-normalizing strategy reduced these aversive effects of communicating scientific uncertainty, resulting in levels of both perceived likelihood of getting COVID-19 and worry about COVID-19 that did not differ from the control message that did not communicate uncertainty. In contrast, the hope-promoting and prosocial strategies did not decrease ambiguity-averse responses to scientific uncertainty. Age and political affiliation, respectively, moderated the effects of uncertainty communication strategies on intentions for COVID-19 risk-reducing behaviors and worry about COVID-19. CONCLUSIONS: Communicating scientific uncertainty about the COVID-19 pandemic produces ambiguity-averse cognitive and emotional, but not behavioral, responses among the general public, and an uncertainty-normalizing communication strategy reduces these responses. Normalizing uncertainty may be an effective strategy for mitigating ambiguity aversion in crisis communication efforts. More research is needed to test uncertainty-normalizing communication strategies and to elucidate the factors that moderate their effectiveness.

An 11-Item Measure of User- and Human-Centered Design for Personal Health Tools (UCD-11): Development and Validation.

BACKGROUND: Researchers developing personal health tools employ a range of approaches to involve prospective users in design and development. OBJECTIVE: The aim of this paper was to develop a validated measure of the human- or user-centeredness of design and development processes for personal health tools. METHODS: We conducted a psychometric analysis of data from a previous systematic review of the design and development processes of 348 personal health tools. Using a conceptual framework of user-centered design, our team of patients, caregivers, health professionals, tool developers, and researchers analyzed how specific practices in tool design and development might be combined and used as a measure. We prioritized variables according to their importance within the conceptual framework and validated the resultant measure using principal component analysis with Varimax rotation, classical item analysis, and confirmatory factor analysis. RESULTS: We retained 11 items in a 3-factor structure explaining 68% of the variance in the data. The Cronbach alpha was .72. Confirmatory factor analysis supported our hypothesis of a latent construct of user-centeredness. Items were whether or not: (1) patient, family, caregiver, or surrogate users were involved in the steps that help tool developers understand users or (2) develop a prototype, (3) asked their opinions, (4) observed using the tool or (5) involved in steps intended to evaluate the tool, (6) the process had 3 or more iterative cycles, (7) changes between cycles were explicitly reported, (8) health professionals were asked their opinion and (9) consulted before the first prototype was developed or (10) between initial and final prototypes, and (11) a panel of other experts was involved. CONCLUSIONS: The User-Centered Design 11-item measure (UCD-11) may be used to quantitatively document the user/human-centeredness of design and development processes of patient-centered tools. By building an evidence base about such processes, we can help ensure that tools are adapted to people who will use them, rather than requiring people to adapt to tools.

Surrogate Satisfaction with Decision Making After Intracerebral Hemorrhage.

BACKGROUND/OBJECTIVE: Surrogate decision makers for patients with intracerebral hemorrhage (ICH) are frequently asked to make difficult decisions on use of life-sustaining treatments. We explored ICH surrogate satisfaction with decision making and experience of decision regret using validated measures in a prospective multicenter study. METHODS: Cases of non-traumatic ICH were enrolled from three hospitals (September 2015-December 2016), and surrogate decision makers were invited to complete a self-administered survey. The primary outcome was the 10-item decision-making subscale of the Family Satisfaction in the Intensive Care Unit scale (FSICU-DM, range 0-100, higher is greater satisfaction), and the secondary outcome was the decision regret scale (range 0-100, higher is greater regret). Linear regression models were used to assess the association between satisfaction with decision making and pre-specified covariates using manual backward selection. RESULTS: A total of 73 surrogates were approached for participation (in person or mail), with 48 surrogates returning a completed survey (median surrogate age 60.5 years, 63% female, 77% white). Patients had a median age of 72.5, 54% were female, with a median admission Glasgow coma scale of 10, in-hospital mortality of 31%, and 56% with an in-hospital DNR order. Physicians commonly made treatment recommendation (> 50%) regarding brain surgery or transitions to comfort measures, but rarely made recommendations (< 20%) regarding DNR orders. Surrogate satisfaction with decision making was generally high (median FSICU-DM 85, IQR 57.5-95). Factors associated with higher satisfaction on multivariable analysis included greater use of shared decision making (P < 0.0001), younger patient age (p = 0.02), ICH score of 3 or higher (p = 0.03), and surrogate relationship (spouse vs. other, p = 0.02). Timing of DNR orders was not associated with satisfaction (P > 0.25). Decision regret scores were generally low (median 12.5, IQR 0-31.3). CONCLUSIONS: Considering the severity and abruptness of ICH, it is reassuring that surrogate satisfaction with decision making was generally high and regret was generally low. However, more work is needed to define the appropriate outcome measures and optimal methods of recruitment for studies of surrogate decision makers of ICH patients.

Head to head randomized trial of two decision aids for prostate cancer.

BACKGROUND: While many studies have tested the impact of a decision aid (DA) compared to not receiving any DA, far fewer have tested how different types of DAs affect key outcomes such as treatment choice, patient-provider communication, or decision process/satisfaction. This study tested the impact of a complex medical oriented DA compared to a more simplistic decision aid designed to encourage shared decision making in men with clinically localized prostate cancer. METHODS: 1028 men at 4 VA hospitals were recruited after a scheduled prostate biopsy. Participants completed baseline measures and were randomized to receive either a simple or complex DA. Participants were men with clinically localized cancer (N = 285) by biopsy and who completed a baseline survey. Survey measures: baseline (biopsy); immediately prior to seeing the physician for biopsy results (pre- encounter); one week following the physician visit (post-encounter). Outcome measures included treatment preference and treatment received, knowledge, preference for shared decision making, decision making process, and patients' use and satisfaction with the DA. RESULTS: Participants who received the simple DA had greater interest in shared decision making after reading the DA (p = 0.03), found the DA more helpful (p's < 0.01) and were more likely to be considering watchful waiting (p = 0.03) compared to those receiving the complex DA at Time 2. While these differences were present before patients saw their urologists, there was no difference between groups in the treatment patients received. CONCLUSIONS: The simple DA led to increased desire for shared decision making and for less aggressive treatment. However, these differences disappeared following the physician visit, which appeared to change patients' treatment preferences. Trial registration This trial was pre-registered prior to recruitment of participants.