Intensive Blood Pressure Lowering in Individuals With Low Diastolic Blood Pressure and Elevated Troponin Levels in SPRINT.

BACKGROUND: Among individuals with hypertension and low diastolic blood pressure (DBP), the optimal BP target remains controversial due to concerns that BP lowering may reduce coronary perfusion. We determined the impact of intensive BP control among individuals with elevated systolic BP who have low DBP and elevated hs-cTnT (high-sensitivity cardiac troponin T) levels. METHODS AND RESULTS: A total of 8828 participants in SPRINT (Systolic Blood Pressure Intervention Trial) were stratified by baseline DBP. Those with low DBP (<70 mm Hg) were further stratified by elevated hs-cTnT (≥14 ng/L) at baseline. The effects of intensive versus standard BP lowering on a cardiovascular disease composite end point, all-cause death, and 1-year change in hs-cTnT were determined. The combination of low DBP/high hs-cTnT was independently associated with a higher risk for cardiovascular disease and all-cause death, as well as greater 1-year increases in hs-cTnT, compared with DBP ≥70 mm Hg. However, randomization to intensive versus standard BP lowering led to similar reductions in cardiovascular disease risk among individuals with low DBP/high hs-cTnT (hazard ratio [HR], 0.82 [95% CI, 0.57-1.19]), low DBP/low hs-cTnT (HR, 0.48 [95% CI, 0.29-0.79]), and DBP ≥70 mm Hg (HR, 0.73 [95% CI, 0.60-0.89]; P for interaction=0.20). Intensive BP lowering also led to a reduction in all-cause death that was similar across groups (P for interaction=0.57). CONCLUSIONS: In this nonprespecified subgroup analysis of SPRINT, individuals with low DBP and elevated hs-cTnT, low DBP and nonelevated hs-cTnT, and DBP ≥70 mm Hg derived similar cardiovascular disease and mortality benefits from intensive BP lowering. These findings warrant confirmation in other studies.

Does haste make waste? Prevalence and types of errors reported after publication of studies of COVID-19 therapeutics.

BACKGROUND: The COVID-19 pandemic spurred publication of a rapid proliferation of studies on potential therapeutic agents. While important for the advancement of clinical care, pressure to collect, analyze, and report data in an expedited manner could potentially increase the rate of important errors, some of which would be captured in published errata. We hypothesized that COVID-19 therapeutic studies published in the early years of the pandemic would be associated with a high rate of published errata and that, within these errata, there would be a high prevalence of serious errors. METHODS: We performed a review of published errata associated with empirical studies of COVID-19 treatments. Errata were identified via a MEDLINE and Embase search spanning January 2020 through September 2022. Errors located within each published erratum were characterized by location within publication, error type, and error seriousness. RESULTS: Of 47 studies on COVID-19 treatments with published errata, 18 met inclusion criteria. Median time from publication of the original article to publication of the associated erratum was 76 days (range, 12-511 days). A majority of errata addressed issues with author attribution or conflict of interest disclosures (39.5%) or numerical results (25.6%). Only one erratum contained a serious error: a typographical error which could have misled readers into believing that the treatment in question had serious adverse effects when in fact it did not. CONCLUSIONS: Despite accelerated publication times, we found among studies of COVID-19 treatments the majority of errata (17/18) reported minor errors that did not lead to misinterpretation of the study results. Retractions, an indicator of scientific misdirection even more concerning than errata, were beyond the scope of this review.

Racial and Ethnic Representativeness of California Medical Schools, 2021.

This cross-sectional study evaluates representation of racial and ethnic groups underrepresented in medicine among students attending California medical schools based on whether the representation standard is calculated at the local, state, or national level.

Effect of Technology-Enhanced Screening in Addition to Standard Targeted Clinician Education on the Duration of Untreated Psychosis: A Cluster Randomized Clinical Trial.

Importance: Reducing the duration of untreated psychosis (DUP) is essential to improving outcomes for people with first-episode psychosis (FEP). Current US approaches are insufficient to reduce DUP to international standards of less than 90 days. Objective: To determine whether population-based electronic screening in addition to standard targeted clinician education increases early detection of psychosis and decreases DUP, compared with clinician education alone. Design, Setting, and Participants: This cluster randomized clinical trial included individuals aged 12 to 30 years presenting for services between March 2015 and September 2017 at participating sites that included community mental health clinics and school support and special education services. Eligible participants were referred to the Early Diagnosis and Preventative Treatment (EDAPT) Clinic. Data analyses were performed in September and October 2019 for the primary and secondary analyses, with the exploratory subgroup analyses completed in May 2021. Interventions: All sites in both groups received targeted education about early psychosis for health care professionals. In the active screening group, clients also completed the Prodromal Questionnaire-Brief using tablets at intake; referrals were based on those scores and clinical judgment. In the group receiving treatment as usual (TAU), referrals were based on clinical judgment alone. Main Outcomes and Measures: Primary outcomes included DUP, defined as the period from full psychosis onset to the date of the EDAPT diagnostic telephone interview, and the number of individuals identified with FEP or a psychosis spectrum disorder. Exploratory analyses examined differences by site type, completion rates between conditions, and days from service entry to telephone interview. Results: Twenty-four sites agreed to participate, and 12 sites were randomized to either the active screening or TAU group. However, only 10 community clinics and 4 school sites were able to fully implement population screening and were included in the final analysis. The total potentially eligible population size within each study group was similar, with 2432 individuals entering at active screening group sites and 2455 at TAU group sites. A total of 303 diagnostic telephone interviews were completed (178 [58.7%] female individuals; mean [SD] age, 17.09 years [4.57]). Active screening sites reported a significantly higher detection rate of psychosis spectrum disorders (136 cases [5.6%], relative to 65 [2.6%]; P < .001) and referred a higher proportion of individuals with FEP and DUP less than 90 days (13 cases, relative to 4; odds ratio, 0.30; 95% CI, 0.10-0.93; P = .03). There was no difference in mean (SD) DUP between groups (active screening group, 239.0 days [207.4]; TAU group 262.3 days [170.2]). Conclusions and Relevance: In this cluster trial, population-based technology-enhanced screening across community settings detected more than twice as many individuals with psychosis spectrum disorders compared with clinical judgment alone but did not reduce DUP. Screening could identify people undetected in US mental health services. Significant DUP reduction may require interventions to reduce time to the first mental health contact. Trial Registration: ClinicalTrials.gov Identifier: NCT02841956.

Pulmonological issues.

Pediatric leukodystrophies are rare neurodegenerative diseases involving multiple systems. Each form has unique neurologic features but are characterized by encephalopathy with accompanying impairments evidenced in reflexes, muscle tone and movement control. Weakness of expiratory, inspiratory, and upper airway muscles may lead to impaired airway secretion clearance resulting in recurrent respiratory infections, dysphagia, sleep-disordered breathing, restrictive lung disease, and ultimately chronic respiratory insufficiency.

Development and Testing of a Communication Intervention to Improve Chronic Pain Management in Primary Care: A Pilot Randomized Clinical Trial.

OBJECTIVES: Effective communication skills are essential for optimally managing chronic pain and opioids. This exploratory, sequential mixed methods study tested the effect of a novel framework designed to improve pain-related communication and outcomes. METHODS: Study 1 developed a novel 5-step framework for helping primary care clinicians discuss chronic pain and opioids with patients. Study 2 pilot tested an intervention for teaching this framework using standardized patient instructors-actors trained to portray patients and provide immediate clinician feedback-deployed during regular clinic hours. Primary care physicians were randomized to receive either the intervention or pain management recommendations from the Centers for Disease Control and Prevention. Primary outcomes were pain-related interference at 2 months and clinician use of targeted communication skills (coded from transcripts of audio-recorded visits); secondary outcomes were pain intensity at 2 months, clinician self-efficacy for communicating about chronic pain, patient experience, and clinician-reported visit difficulty. RESULTS: We enrolled 47 primary care physicians from 2 academic teaching clinics and recorded visits with 48 patients taking opioids for chronic pain who had an appointment scheduled with an enrolled physician. The intervention was not associated with significant changes in primary or secondary outcomes other than clinician self-efficacy, which was significantly greater in the intervention group. DISCUSSION: This study developed a novel framework and intervention for teaching clinician pain-related communications skills. Although the intervention showed promise, more intensive or multicomponent interventions may be needed to have a significant impact on clinicians' pain-related communication and pain outcomes.

Ethical and methodological challenges slowing progress in primary care-based suicide prevention: Illustrations from a randomized controlled trial and guidance for future research.

INTRODUCTION: Despite the pressing need for primary care-based suicide prevention initiatives and growing acknowledgement of recruitment difficulties and Institutional Review Board (IRB) challenges in suicide research, we are aware of no illustrative examples describing how IRB decisions in the design of a primary care trial can compound recruitment challenges. METHODS: The CDC-funded trial (NCT02986113) of Men and Providers Preventing Suicide aimed to examine the effects of a tailored computer program encourage men with suicidal thoughts (n = 304, ages 35-64) to discuss suicide with a primary care clinician and accept treatment. Before a visit, participants viewed MAPS or a non-tailored control video. Post-visit, both arms were offered telephone collaborative care, as mandated by the institutional review board (IRB). We previously showed that exposure to MAPs led to improvements in communication about suicide in a primary care visit. In this paper, we report data on the study's primary outcome, suicide preparatory behaviors. RESULTS: After screening nearly 4100 men, 48 enrolled. Recruitment challenges, which were exacerabted by an IRB mandate narrowing post-intervention patient management differences between trial arms, limited detection of the effects of MAPS on suicide preparatory behaviors. CONCLUSIONS: While primary care settings are key sites for suicide prevention trials, issues such as recruitment difficulties and overly restrictive IRB requirements may limit their utility. Methodological innovation to improve recruitment and ethical guidance to inform IRB decision-making are needed.

Health Information Seeking From an Intelligent Web-Based Symptom Checker: Cross-sectional Questionnaire Study.

BACKGROUND: The ever-growing amount of health information available on the web is increasing the demand for tools providing personalized and actionable health information. Such tools include symptom checkers that provide users with a potential diagnosis after responding to a set of probes about their symptoms. Although the potential for their utility is great, little is known about such tools' actual use and effects. OBJECTIVE: We aimed to understand who uses a web-based artificial intelligence-powered symptom checker and its purposes, how they evaluate the experience of the web-based interview and quality of the information, what they intend to do with the recommendation, and predictors of future use. METHODS: Cross-sectional survey of web-based health information seekers following the completion of a symptom checker visit (N=2437). Measures of comprehensibility, confidence, usefulness, health-related anxiety, empowerment, and intention to use in the future were assessed. ANOVAs and the Wilcoxon rank sum test examined mean outcome differences in racial, ethnic, and sex groups. The relationship between perceptions of the symptom checker and intention to follow recommended actions was assessed using multilevel logistic regression. RESULTS: Buoy users were well-educated (1384/1704, 81.22% college or higher), primarily White (1227/1693, 72.47%), and female (2069/2437, 84.89%). Most had insurance (1449/1630, 88.89%), a regular health care provider (1307/1709, 76.48%), and reported good health (1000/1703, 58.72%). Three types of symptoms-pain (855/2437, 35.08%), gynecological issues (293/2437, 12.02%), and masses or lumps (204/2437, 8.37%)-accounted for almost half (1352/2437, 55.48%) of site visits. Buoy's top three primary recommendations split across less-serious triage categories: primary care physician in 2 weeks (754/2141, 35.22%), self-treatment (452/2141, 21.11%), and primary care in 1 to 2 days (373/2141, 17.42%). Common diagnoses were musculoskeletal (303/2437, 12.43%), gynecological (304/2437, 12.47%) and skin conditions (297/2437, 12.19%), and infectious diseases (300/2437, 12.31%). Users generally reported high confidence in Buoy, found it useful and easy to understand, and said that Buoy made them feel less anxious and more empowered to seek medical help. Users for whom Buoy recommended "Waiting/Watching" or "Self-Treatment" had strongest intentions to comply, whereas those advised to seek primary care had weaker intentions. Compared with White users, Latino and Black users had significantly more confidence in Buoy (P<.05), and the former also found it significantly more useful (P<.05). Latino (odds ratio 1.96, 95% CI 1.22-3.25) and Black (odds ratio 2.37, 95% CI 1.57-3.66) users also had stronger intentions to discuss recommendations with a provider than White users. CONCLUSIONS: Results demonstrate the potential utility of a web-based health information tool to empower people to seek care and reduce health-related anxiety. However, despite encouraging results suggesting the tool may fulfill unmet health information needs among women and Black and Latino adults, analyses of the user base illustrate persistent second-level digital divide effects.

The Stress and Resilience Town Hall: A systems response to support the health workforce during COVID-19 and beyond.

OBJECTIVE: The COVID-19 pandemic is a traumatic stressor resulting in anxiety, depression, post-traumatic stress, and burnout among healthcare workers. We describe an intervention to support the health workforce and summarize results from its 40-week implementation in a large, tri-state health system during the COVID-19 pandemic. METHOD: We conducted 121 virtual and interactive Stress and Resilience Town Halls attended by 3555 healthcare workers. Town hall participants generated 1627 stressors and resilience strategies that we coded and analyzed using rigorous qualitative methods (Kappa = 0.85). RESULTS: We identify six types of stressors and eight types of resilience strategies reported by healthcare workers, how these changed over time, and how town halls were responsive to emerging health workforce needs. We show that town halls dedicated to groups working together yielded 84% higher mean attendance and more sharing of stressors and resilience strategies than those offered generally across the health system, and that specific stressors and strategies are reported consistently while others vary markedly over time. CONCLUSIONS: The virtual and interactive Stress and Resilience Town Hall is an accessible, scalable, and sustainable intervention to build mutual support, wellness, and resilience among healthcare workers and within hospitals and health systems responding to emerging crises, pandemics, and disasters.

Use of Child Care Attenuates the Link Between Decreased Maternal Sleep and Increased Depressive Symptoms.

OBJECTIVE: Sleep disruption is common among postpartum women and is linked with depression. Child care may alleviate parenting stress and protect new mothers against symptoms of depression. METHODS: Mothers from the NURTURE study, a birth cohort of 666 women of full-term infants, completed questionnaires during home visits when their infants were 3, 6, 9, and 12 months old. The Edinburgh Postnatal Depression Scale and the Perceived Stress Scale were used to measure depressive symptoms and stress, respectively. Mothers reported total nightly sleep duration for themselves and their infants, child care arrangements, marital status, and income. We used mixed-effects models adjusting for income, marital status, and child age to examine the indirect effect of infants' sleep on maternal mental health through mothers' sleep and assessed whether patterns differed depending on child care. RESULTS: Decreased maternal sleep mediated the association between infant sleep and maternal mental health. When infants slept 1 hour less than usual, mothers slept 7 fewer minutes (B = 0.19, 95% confidence interval [CI], 0.01 to 0.27) and reported more depressive symptoms (B = -0.27, 95% CI, -0.43 to -0.11) and stress (B = -0.33, 95% CI -0.58 to -0.09). Child care moderated the indirect effect; decreased maternal sleep was not associated with increased depressive symptoms (and was not a mediator) when mothers had child care (indirect effect = -0.001, 95% CI, -0.03 to 0.03). CONCLUSION: Use of infant child care reduced the link between maternal sleep and depressive symptoms. Regular access to child care may be a method to mitigate feelings of depression for new mothers.

Patient, caregiver, and oncologist predictions of quality of life in advanced cancer: Accuracy and associations with end-of-life care and caregiver bereavement.

BACKGROUND: Informed treatment decision-making necessitates accurate prognostication, including predictions about quality of life. AIMS: We examined whether oncologists, patients with advanced cancer, and caregivers accurately predict patients' future quality of life and whether these predictions are prospectively associated with end-of-life care and bereavement. MATERIALS & METHODS: We conducted secondary analyses of clinical trial data. Patients with advanced cancer (n = 156), caregivers (n = 156), and oncologists (n = 38) predicted patient quality of life 3 months into the future. Patients subsequently rated their quality of life 3 months later. Medical record data documented chemotherapy and emergency department (ED)/inpatient visits in the 30 days before death (n = 79 decedents). Caregivers self-reported on depression, anxiety, grief, purpose, and regret 7-months post-mortem. In mixed-effects models, patient, caregiver, and oncologist quality-of-life predictions at study entry were used to predict end-of-life care and caregiver outcomes, controlling for patients' quality of life at 3-month follow-up, demographic and clinical characteristics, and nesting within oncologists. RESULTS: Caregivers (P < 0.0001) and oncologists (P = 0.001) predicted lower quality of life than what patients actually experienced. Among decedents, 24.0% received chemotherapy and 54.5% had an ED/inpatient visit. When caregivers' predictions were more negative, patients were less likely to receive chemotherapy (P = 0.028) or have an ED/inpatient visit (P = 0.033), and caregivers reported worse depression (P = 0.002), anxiety (P = 0.019), and grief (P = 0.028) and less purpose in life (P < 0.001) 7-months post-mortem. CONCLUSION: When caregivers have more negative expectations about patients' quality of life, patients receive less intensive end-of-life care, and caregivers report worse bereavement outcomes.

A Useful and Sustainable Role for N-of-1 Trials in the Healthcare Ecosystem.

Clinicians and patients often try a treatment for an initial period to inform longer-term therapeutic decisions. A more rigorous approach involves N-of-1 trials. In these single-patient crossover trials, typically conducted in patients with chronic conditions, individual patients are given candidate treatments in a double-blinded, random sequence of alternating periods to determine the most effective treatment for that patient. However, to date, these trials are rarely done outside of research settings and have not been integrated into general care where they could offer substantial benefit. Designating this classical, N-of-1 trial design as type 1, there also are new and evolving uses of N-of-1 trials that we designate as type 2. In these, rather than focusing on optimizing treatment for chronic diseases when multiple approved choices are available, as is typical of type 1, a type 2 N-of-1 trial tests treatments designed specifically for a patient with a rare disease, to facilitate personalized medicine. While the aims differ, both types face the challenge of collecting individual-patient evidence using standard, trusted, widely accepted methods. To fulfill their potential for producing both clinical and research benefits, and to be available for wide use, N-of-1 trials will have to fit into the current healthcare ecosystem. This will require generalizable and accepted processes, platforms, methods, and standards. This also will require sustainable value-based arrangements among key stakeholders. In this article, we review opportunities, stakeholders, issues, and possible approaches that could support general use of N-of-1 trials and deliver benefit to patients and the healthcare enterprise. To assess and expand the benefits of N-of-1 trials, we propose multistakeholder meetings, workshops, and the generation of methods, standards, and platforms that would support wider availability and the value of N-of-1 trials.

Conduct and Implementation of Personalized Trials in Research and Practice.

The mainstay of evidence development in medicine is the parallel-group randomized controlled trial (RCT), which generates estimates of treatment efficacy or effectiveness for the average person in the trial. In contrast, personalized trials (sometimes referred to as 'single-person trials' or 'N-of-1 trials') assess the comparative effectiveness of two or more treatments in a single individual. These single-subject, randomized crossover trials have been used in a scattershot fashion in medicine for over 40 years but have not been widely adopted. An important barrier is the paucity of strong evidence that personalized trials improve outcomes. However, the principal impediment may have less to do with proof of efficacy than with practical aspects of design and implementation. These include decisions about treatment regimen flexibility, blinding, and washout periods as well as organizational, clinician, and patient-level challenges. After reviewing the essential elements of personalized trials, this article addresses these speed bumps and fundamentally asks, 'Why have personalized trials not been more widely adopted, and how can they be made more readily deployable and useful?' The article concludes by suggesting ways in which emerging technologies and approaches promise to overcome existing barriers and open promising vistas for the next generation of personalized-trial researchers and practitioners.

Personalized Data Science and Personalized (N-of-1) Trials: Promising Paradigms for Individualized Health Care.

The term 'data science' usually refers to the process of extracting value from big data obtained from a large group of individuals. An alternative rendition, which we call personalized data science (Per-DS), aims to collect, analyze, and interpret personal data to inform personal decisions. This article describes the main features of Per-DS, and reviews its current state and future outlook. A Per-DS investigation is of, by, and for an individual, the Per-DS investigator, acting simultaneously as her own investigator, study participant, and beneficiary, and making personalized decisions for study design and implementation. The scope of Per-DS studies may include systematic monitoring of physiological or behavioral patterns, case-crossover studies for symptom triggers, pre-post trials for exposure-outcome relationships, and personalized (N-of-1) trials for effectiveness. Per-DS studies produce personal knowledge generalizable to the individual's future self (thus benefiting herself) rather than knowledge generalizable to an external population (thus benefiting others). This endeavor requires a pivot from data mining or extraction to data gardening, analogous to home gardeners producing food for home consumption-the Per-DS investigator needs to 'cultivate the field' by setting goals, specifying study design, identifying necessary data elements, and assembling instruments and tools for data collection. Then, she can implement the study protocol, harvest her personal data, and mine the data to extract personal knowledge. To facilitate Per-DS studies, Per-DS investigators need support from community-based, scientific, philanthropic, business, and government entities, to develop and deploy resources such as peer forums, mobile apps, 'virtual field guides,' and scientific and regulatory guidance.

Visit Linearity in Primary Care Visits for Patients with Chronic Pain on Long-term Opioid Therapy.

BACKGROUND: Physicians and patients report frustration after primary care visits for chronic pain. The need to shift between multiple clinical topics to address competing demands during visits may contribute to this frustration. OBJECTIVE: This study creates a novel measure, "visit linearity," to assess visit organization and examines whether visits that require less shifting back and forth between topics are associated with better patient and physician visit experiences. It also explores whether visit linearity differs depending on the following: (1) whether or not pain is a major topic of the visit and (2) whether or not pain is the first topic raised. DESIGN: This study analyzed 41 video-recorded visits using inductive, qualitative analysis informed by conversation analysis. We used linear regression to evaluate associations between visit organization and post-visit measures of participant experience. PARTICIPANTS: Patients were established adult patients planning to discuss pain management during routine primary care. Physicians were internal or family medicine residents. MAIN MEASURES: Visit linearity, total topics, return topics, topic shifts, time per topic, visit duration, pain main topic, pain first topic, patient experience, and physician difficulty. KEY RESULTS: Visits had a mean of 8.1 total topics (standard deviation (SD)=3.46), 14.5 topic shifts (SD=6.28), and 1.9 topic shifts per topic (SD=0.62). Less linear visits (higher topic shifts to topic ratio) were associated with greater physician visit difficulty (ß=7.28, p<0.001) and worse patient experience (ß= -0.62, p=0.03). Visit linearity was not significantly impacted by pain as a major or first topic raised. CONCLUSIONS: In primary care visits for patients with chronic pain taking opioids, more linear visits were associated with better physician and patient experience. Frequent topic shifts may be disruptive. If confirmed in future research, this finding implies that reducing shifts between topics could help decrease mutual frustration related to discussions about pain.

Associations Among Food Security, Diet Quality, and Dietary Intake During Pregnancy in a Predominantly African American Group of Women from North Carolina.

BACKGROUND: Low food security during pregnancy can negatively affect women's physical and mental health. Although many women make a greater effort to eat a healthy diet during pregnancy, the influence of low food security during pregnancy on maternal diet is not well understood. OBJECTIVE: This study aimed to assess the association between adult food security and maternal diet during pregnancy in a sample from North Carolina. DESIGN: This was a cross-sectional, secondary data analysis of food security (marginal, low, and very low vs high) and maternal diet during pregnancy. PARTICIPANTS AND SETTING: This study included 468 predominantly Black/African American women during pregnancy from the Nurture cohort, enrolled through prenatal clinics in central North Carolina between 2013 and 2016. MAIN OUTCOME MEASURE: Diet quality was assessed using the Alternate Healthy Eating Index-Pregnancy and the Mediterranean Diet Score. Dietary intake from seven food groups included in the Alternate Healthy Eating Index-Pregnancy and/or Mediterranean Diet Score was assessed as well. STATISTICAL ANALYSIS PERFORMED: Multiple linear regression models were used to examine the association between food security and diet quality and dietary intake during pregnancy, adjusting for race/ethnicity; participation in the Special Supplemental Nutrition Program for Women, Infants, and Children; education; prepregnancy body mass index; age; parity; and mean daily energy intake. RESULTS: In this study, there was no association between maternal food security status and diet quality during pregnancy. However, researchers observed an association between low and marginal food security and greater intake of red and processed meats (marginal: ß = 2.20 [P = 0.03]; low: ß = 2.28 [P = 0.04]), as well as an association between very low food security and decreased vegetable consumption (ß = -.43; P = 0.03). CONCLUSIONS: Very low food security was associated with reduced vegetable intake. In addition, low and marginal food security were associated with greater red and processed meat intake. Future research should focus on nationally representative populations and include longitudinal assessments to allow for the study of the influence of food security on health during pregnancy.

Trust and shared decision-making among individuals with multiple myeloma: A qualitative study.

BACKGROUND: Multiple myeloma (MM) is an incurable cancer with complex treatment options. Trusting patient-clinician relationships are essential to promote effective shared decision-making that aligns best clinical practices with patient values and preferences. This study sought to shed light on the development of trust between MM patients and clinicians. METHODS: Nineteen individual semi-structured interviews were conducted with MM patients within 2 years of initial diagnosis or relapse for this qualitative study. Interviews were recorded and transcripts were coded thematically. RESULTS: We identified three main themes: (1) externally validated trust describes patients' predisposition to trust or distrust clinicians based on factors outside of patient-clinician interactions; (2) internally validated trust describes how patients develop trust based on interactions with specific clinicians. Internally validated trust is driven primarily by clinician communication practices that demonstrate competence, responsiveness, listening, honesty, and empathy; and (3) trust in relation to shared decision-making describes how patients relate the feeling of trust, or lack thereof, to the process of shared decision-making. CONCLUSION: Many factors contribute to the development of trust between MM patients and clinicians. While some are outside of clinicians' control, others derive from clinician behaviors and interpersonal communication skills. These findings suggest the possibility that trust can be enhanced through communication training or shared decision-making tools that emphasize relational communication. Given the important role trust plays in shared decision-making, clinicians working with MM patients should prioritize establishing positive, trusting relationships.

Chronic pain treatment preferences change following participation in N-of-1 trials, but not always in the expected direction.

OBJECTIVE: To examine pain treatment preferences before and after participation in an N-of-1 trial. STUDY DESIGN AND SETTING: In this observational study nested within a randomized trial, we examined chronic pain patients' preferences before and after treatment in relation to N-of-1 trial results; assessed the influence of different schemes for defining comparative "superiority" on potential conclusions; and generated classification trees illustrating the relationship between pre-treatment preferences, N-of-1 trial results, and post-treatment preferences. RESULTS: Treatment preferences differed pre- and post-trial for 40% of participants. The proportion of patients whose N-of-1 trials demonstrated "superiority" of one treatment regimen over the other varied depending on how superiority was defined and ranged from 24% (using criteria that required statistically significant differences between regimens) to 62% (when relying only on differences in point estimates). Regardless of criteria for declaring treatment superiority, nearly three-fourths of patients with equivocal N-of-1 trial results nevertheless expressed definite preferences post-trial. CONCLUSION: A large segment of patients undergoing N-of-1 trials for chronic pain altered their treatment preferences. However, the direction of preference change did not necessarily correspond to the N-of-1 results. More research is needed to understand how patients use N-of-1 trial results, why preferences are "sticky" even in the face of personalized data, and how patients and clinicians might be educated to use N-of-1 trial results more informatively.

Associations between daily screen time and sleep in a racially and socioeconomically diverse sample of US infants: a prospective cohort study.

OBJECTIVE: To determine the associations between screen media use and sleep throughout infancy (3-12 months). DESIGN: Prospective Nurture birth cohort. SETTING: North Carolina, USA, 2013-2015. PARTICIPANTS: Women enrolled in their second to third trimester, completed a phone interview after birth, and completed home visits at 3, 6, 9 and 12 months post partum. PRIMARY AND SECONDARY OUTCOME MEASURES: Women reported the usual hours their infants slept during the day and night and their infants' usual use of five screen media activities at 3, 6, 9 and 12 months post partum. Adjusted mixed-effects regression analyses modelled the associations between infant screen time and sleep outcomes while disaggregating the between-infant and within-infant effects. RESULTS: Among 558 mother-infant dyads, 374 (67.0%) infants were black and 304 (54.5%) households earned <$20 000 per year. Half (254, 50.2%) of the infants engaged with screens at 3 months of age, while 326 (72.9%) engaged at 12 months. The median value of the average daily screen time over the study period was 50 (IQR: 10-141) min. Infant screen time was inversely associated with night-time sleep duration only when considering between-infant effects (adjusted beta: -2.9; 95% CI -5.9 to 0.0; p=0.054 for log-transformed screen time). Effects were stronger for television+DVD viewing specifically (adjusted beta: -5.2; 95% CI -9.1 to -1.4; p<0.01 for log-transformed television+DVD time). For example, an infant who averaged 1 hour of television+DVD viewing over the study period slept, on average, 9.20 (95% CI 9.02 to 9.37) hours per night by 12 months compared with 9.60 (95% CI 9.41 to 9.80) hours per night for an infant with no screen time over the study period. There were no significant within-infant effects between screen time and night-time sleep, and screen time was not associated with daytime sleep or night-time awakenings. CONCLUSIONS: Screen time during infancy was inversely associated with night-time sleep duration; however, causal associations remain uncertain. TRIAL REGISTRATION NUMBER: NCT01788644.