Self-identified rurality in a nationally representative population in the US.

INTRODUCTION: In the US, health services research most often relies on Rural-Urban Commuting Area (RUCA) classification codes to measure rurality. This measure is known to misrepresent rurality and does not rely on individual experiences of rurality associated with healthcare inequities. We aimed to determine a patient-centered RUCA-based definition of rurality. METHODS: In this cross-sectional study, we conducted an online survey asking US residents, 'Do you live in a rural area?' and the rationale for their answer. We evaluated the concordance between their self-identified rurality and their ZIP code-derived RUCA designation of rurality by calculating Cohen's kappa (κ) statistic and percent agreement. RESULTS: Of the 774 participants, 456 (58.9%) and 318 (41.1%) individuals had conventional urban and rural RUCA classifications, respectively. There was only moderate agreement between perceived rurality and rural RUCA classification (κ=0.48; 95% confidence interval (CI)=0.42-0.54). Among people living within RUCA 2-3 defined urban areas (n=51), percent agreement was only 19.6%. Discordance was driven by their perception of the population density, proximity to the nearest neighbor, proximity to a metropolitan area, and the number of homes in their area. Based on our results, we reclassified RUCA 2-3 designations as rural, resulting in an increase in overall concordance (κ=0.56; 95%CI=0.50-0.62). DISCUSSION: Patient-centered rural-urban classification is required to effectively evaluate the impact of rurality on health disparities. This study presents a more patient-centric RUCA-based classification of rurality that can be easily operationalized in future research in situations in which self-reported rural status is missing or challenging to obtain. CONCLUSION: Reclassification of RUCA 2-3 as rural represents a more patient-centric definition of rurality.

A Qualitative Analysis of Factors Influencing Critical Care Trial Enrollment Among Surrogates.

BACKGROUND: We sought to identify factors that influence surrogate decision makers' decisions to enroll patients into a critical care randomized controlled trial. METHODS: We conducted a qualitative study embedded within a randomized controlled trial testing the effect of a behavioral nudge intervention for surrogate decision makers on enrollment rate in a sham ventilatory weaning trial among patients with acute respiratory failure. Participants were adult surrogate decision makers of patients receiving mechanical ventilation for acute respiratory failure. The study was conducted in 10 ICUs across 2 urban hospitals within an academic medical center in Philadelphia, Pennsylvanaia, United States. Immediately following their trial enrollment decision, surrogate decision makers were asked to enter free-text responses about the factors that influenced their decision. Responses were analyzed using content analysis. RESULTS: Of the 90 (49%) participants who provided free-text responses, the mean age was 54.9 years (SD 14.3), 69 (79%) were Caucasian, and 48 (53%) were the spouse of the eligible patient. We identified 5 themes influencing enrollment decisions: (i) trial characteristics, (ii) patient clinical condition, (iii) decision making processes, (iv) altruism, and (v) enrollment attempt. Among surrogates who enrolled the patient in the trial (n = 40), the most commonly cited factors were helping future patients (n = 24, 60%) and following the patient's wishes (n = 11, 28%). In contrast, those who declined enrollment (n = 50) most commonly reported that the patient was too sick (n = 27, 54%) and that they feared complicating the patient's condition (n = 11, 22%). CONCLUSIONS: Surrogates who enroll patients into trials most often cite altruistic motivations, while those who decline enrollment are most often concerned with the severity of the patients' condition.

A systematic review and meta-analysis of enrollment into ARDS and sepsis trials published between 2009 and 2019 in major journals.

BACKGROUND: Enrollment problems are common among randomized controlled trials conducted in the ICU. However, little is known about actual trial enrollment rates and influential factors. We set out to determine the overall enrollment rate in recent randomized controlled trials (RCTs) of patients with acute respiratory distress syndrome (ARDS), acute lung injury (ALI), or sepsis, and which factors influenced enrollment rate. METHODS: We conducted a systematic review by searching Pubmed using predefined terms for ARDS/ALI and sepsis to identify individually RCTs published among the seven highest impact general medicine and seven highest impact critical care journals between 2009 and 2019. Cluster randomized trials were excluded. Data were extracted by two independent reviewers using an electronic database management system. We conducted a random-effects meta-analysis of the eligible trials for the primary outcome of enrollment rate by time and site. RESULTS: Out of 457 articles identified, 94 trials met inclusion criteria. Trials most commonly evaluated pharmaceutical interventions (53%), were non-industry funded (78%), and required prospective informed consent (81%). The overall mean enrollment rate was 0.83 (95% confidence interval: 0.57-1.21) participants per month per site. Enrollment in ARDS/ALI and sepsis trials were 0.48 (95% CI 0.32-0.70) and 0.98 (95% CI 0.62-1.56) respectively. The enrollment rate was significantly higher for single-center trials (4.86; 95% CI 2.49-9.51) than multicenter trials (0.52; 95% CI 0.41-0.66). Of the 36 trials that enrolled < 95% of the target sample size, 8 (22%) reported slow enrollment as the reason. CONCLUSIONS: In this systematic review and meta-analysis, recent ARDS/ALI and sepsis clinical trials had an overall enrollment rate of less than 1 participant per site per month. Novel approaches to improve critical care trial enrollment efficiency are needed to facilitate the translation of best evidence into practice.

Idiopathic hyperammonemia after solid organ transplantation: Primarily a lung problem? A single-center experience and systematic review.

BACKGROUND: Idiopathic hyperammonemia syndrome (IHS) is an uncommon, often deadly complication of solid organ transplantation. IHS cases in solid organ transplantation seem to occur predominantly in lung transplant (LTx) recipients. However, to the best of our knowledge, the occurrence of IHS has not been systematically evaluated. We set out to identify all reported cases of IHS following nonliver solid organ transplantations. METHODS: Retrospective review of our institutional experience and systematic review of the literature. RESULTS: At our institution six cases (of 844 nonliver solid organ transplants) of IHS were identified: five occurred following LTx (incidence 3.9% [lung] vs 0.1% [nonlung], P=.004). In the systematic review, 16 studies met inclusion criteria, reporting on 32 cases of IHS. The majority of IHS cases in the literature (81%) were LTx-recipients. The average peak reported ammonia level was 1039 µmol/L occurring on average 14.7 days post-transplant. Mortality in previously reported IHS cases was 69%. A single-center experience suggested that, in addition to standard treatment for hyperammonemia, early initiation of high intensity hemodialysis to remove ammonia was associated with increased survival. In the systematic review, mortality was 40% (four of 10) with intermittent hemodialysis, 75% (nine of 12) with continuous veno-venous hemodialysis, and 100% in six subjects that did not receive renal replacement to remove ammonia. Three reports identified infection with urease producing organisms as a possible etiology of IHS. CONCLUSION: IHS is a rare but often fatal complication that primarily affects lung transplant recipients within the first 30 days.

Barriers and Facilitators of Surrogates Providing Consent for Critically Ill Patients in Clinical Trials: A Qualitative Study.

BACKGROUND: Enrollment into critical care clinical trials is often hampered by the need to rely on surrogate decision-makers. To identify potential interventions facilitating enrollment into critical care clinical trials, a better understanding of surrogate decision-making for critical care clinical trial enrollment is needed. RESEARCH QUESTION: What are the barriers and facilitators of critical care trial enrollment? What are surrogate decision-makers' perspectives on proposed interventions to facilitate trial enrollment? STUDY DESIGN AND METHODS: We conducted semistructured interviews with 20 surrogate decision-makers of critically ill patients receiving mechanical ventilation. The interviews were recorded and transcribed verbatim, and analyzed for themes using an inductive approach. RESULTS: Thematic analysis confirmed previous research showing that trust in the system, assessing the risks and benefits of trial participation, the desire to help others, and building medical knowledge as important motivating factors for trial enrollment. Two previously undescribed concerns among surrogate decision-makers of critically ill patients were identified, including the potential to interfere with clinical treatment decisions and negative sentiment about placebos. Surrogates viewed public recognition and charitable donations for participation as favorable potential interventions to encourage trial enrollment. However, participants viewed direct financial incentives and prioritizing research participants during medical rounds negatively. INTERPRETATION: This study confirms and extends previous findings that health system trust, study risks and benefits, altruism, knowledge generation, interference with clinical care, and placebos are key concerns and barriers for surrogate decision-makers to enroll patients in critical care trials. Future studies are needed to evaluate if charitable giving on the patient's behalf and public recognition are effective strategies to promote enrollment into critical care trials.

Correlations of Opioid Intake During Different Predischarge Time Frames with Postdischarge Opioid Use Following Inpatient Surgery.

Previous work has shown that predischarge opioid use is the most reliable and practical predictor of postdischarge opioid intake after inpatient surgery. However, the most appropriate predischarge time frame for operationalizing this relationship into more individualized prescriptions is unknown. We compared the correlations between the quantity of opioids taken during 5 predischarge time frames and self-reported postdischarge opioid intake in 604 adult surgery patients. We found that the 24-hour predischarge time frame was most strongly correlated (ρ= 0.60, P < .001) with postdischarge opioid use and may provide actionable information for predicting opioid use after discharge.

Personal Financial Wellness Curricula for Medical Trainees: A Systematic Review.

PURPOSE: Education debt, poor financial literacy, and a late start to retirement savings can cause financial stress among physicians. This systematic review identifies methods for curriculum development, methods for curriculum delivery, and outcome measures to evaluate the effectiveness of personal financial wellness curricula for medical students, residents, and fellows. METHOD: The authors searched the Embase, MEDLINE (via EBSCO), Scopus, Education Resources Information Center (via EBSCO), and Cochrane Library databases and MedEdPORTAL (via PubMed) on July 28, 2022. Studies must have reported the outcome of at least 1 postcourse assessment to be included. RESULTS: Of the 1,996 unique citations identified, 13 studies met the inclusion criteria. Three curricula (23.1%) were designed for medical students, 8 (61.5%) for residents, 1 (7.7%) for internal medicine fellows, and 1 (7.7%) for obstetrics-gynecology residents and fellows. The most frequently discussed personal finance topics included student loans, investment options, disability insurance, life insurance, retirement savings, budgeting, debt management, and general personal finance. A median (interquartile range) of 3.5 (1.4-7.0) hours was spent on personal finance topics. Eleven curricula (85.6%) relied on physicians to deliver the content. Four studies (30.8%) reported precourse and postcourse financial literacy evaluations, each showing improved financial literacy after the course. Four studies (30.8%) assessed actual or planned financial behavior changes, each credited with encouraging or assisting with financial behavioral changes. One study (7.7%) assessed participants' well-being using the Expanded Well-Being Index, which showed an improvement after the course. CONCLUSIONS: Given the impact educational debt and other financial stressors can have on the wellness of medical trainees, institutions should consider investments in teaching financial literacy. Future studies should report more concrete outcome measures, including financial behavior change and validated measures of wellness.

Relationships among Demographic, Clinical, and Psychological Factors Associated with Family Caregiver Readiness to Participate in Intensive Care Unit Care.

Rationale: There has been a paradigm shift to partner with family caregivers by actively involving them in the direct care of the patient throughout the critical illness trajectory. Before effectively engaging family members in patient care, clinicians must assess characteristics and circumstances that may affect caregiver readiness to assume a caregiving role in the intensive care unit (ICU). Objectives: To determine how demographic, clinical, and psychological factors are related to characteristics of family caregiver readiness to engage in ICU patient care. Methods: A convenience sample of ICU family caregivers of both adult and pediatric patients in the ICU was recruited for this cross-sectional study. Participants completed the following measures: PROMIS-29 (Patient-Reported Outcomes Measurement and Information System); HADS (Hospital Anxiety and Depression Scale); CaSES (Caregiver Self-Efficacy Scale); Prep Scale (Preparedness for Caregiving Scale); Patient Activation Measure for Caregivers; and FCMFHS (Family Caregiver's Motives for Helping Scale). Data were collected via self-report at a single time point while the caregiver was visiting the critically ill patient in the ICU. Data analysis consisted of descriptive statistics and bivariate correlations. Results: Caregivers (N = 127) were primarily White (82.7%), females (77.2%), with a mean age of 51.8 (standard deviation [SD], 15.6). Most were either spouses (37.8%) or parents (32.3%) of the patient in the ICU. Patients were primarily adult (76.4%) with a mean APACHE (Acute Physiology, Age, Chronic Health Evaluation) III of 45.9 (SD, 22.5). There were significant (P < 0.05) negative correlations between depression, anxiety, and fatigue and all subscales of self-efficacy (resilience r = -0.18 to -0.30; self-maintenance r = -0.44 to -0.63; emotional connectivity r = -0.27 to -0.41; instrumental giving r = -0.34 to -0.46). Caregiver depression was negatively correlated with caregiver activation (r = -0.199) and caregiver preparedness (r = -0.300). Social satisfaction was positively correlated (P < 0.05) with caregiving preparedness, motivation, and all subscales of self-efficacy (preparedness r = 0.19; motivation r = 0.24; resilience r = 0.21; self-maintenance r = 0.49; emotional connectivity r = 0.29; instrumental giving r = 0.36). Conclusions: We found that caregiver symptoms of depression, anxiety, and fatigue are inversely related to caregiver preparation, motivation, and self-efficacy. To develop effective interventions for ICU family caregivers, further research is needed to understand the relationship between caregiver well-being, caregiving readiness, and caregiver involvement in patient care.

Family Caregiver Preferences and Contributions Related to Patient Care in the ICU.

Guided by Individual and Family Self-Management Theory, the purpose of this cross-sectional study was to describe patient care activities that family caregivers endorsed and performed while visiting their family member in the ICU. We found that caregivers wanted to be involved in ICU patient care and had preferences for the care they wanted to perform with their critically ill family member. More than 80% preferred to perform tasks related to daily grooming, communication, and education. Of note, many caregivers expressed interest in holistic healing activities (i.e., music and art), and yet, less than 50% of caregivers reported participating in these activities. The discrepancy between the number of care activities that respondents desired to perform compared to the number of care activities they reported performing represents an important opportunity to shift research and practice improvement efforts toward more tailored family engagement interventions and recognition of family caregivers as essential partners in care.

A Randomized Controlled Trial of Behavioral Nudges to Improve Enrollment in Critical Care Trials.

Rationale: Low and slow patient enrollment remains a barrier to critical care randomized controlled trials (RCTs). Behavioral economic insights suggest that nudges may address some enrollment challenges.Objectives: To evaluate the efficacy of a novel preconsent survey consisting of nudges on critical care RCT enrollment.Methods: We conducted an RCT in 10 intensive care units (ICUs) among surrogate decision-makers (SDMs). The novel multicomponent behavioral nudge survey was administered immediately before soliciting SDMs' informed consent for their patients' participation in a sham trial of two mechanical ventilation weaning approaches in acute respiratory failure. The primary outcome was the enrollment rate for the sham trial. Secondary outcomes included undue and unjust inducements. We also explored SDM and patient predictors of enrollment using multivariate regression.Results: Among 182 SDMs, 93 were randomized to receive the intervention survey and 89 to receive standard informed consent. There was no statistically significant difference in enrollment rates between the intervention (29%) and standard consent (34%) groups (percentage difference, 5%; 95% confidence interval [CI], -9% to 18%; P = 0.50). There was no evidence of undue or unjust inducement. White SDMs were more likely to enroll the patient compared with non-white SDMs (odds ratio, 3.7; 95% CI, 1.1 to 12.2; P = 0.03). SDMs who perceived a higher risk of participation were less likely to enroll the patient (odds ratio, 0.57; 95% CI, 0.46 to 0.71; P < 0.001).Conclusions: A preconsent behavioral nudge survey among SDMs of patients with acute respiratory failure in the ICU did not increase enrollment rates for a sham RCT compared with standard informed consent procedures.Clinical trial registered with ClinicalTrials.gov (NCT03284359).

A pilot randomized trial of five financial incentive strategies to increase study enrollment and retention rates.

BACKGROUND: Enrollment and retention difficulties remain major barriers to conducting clinical trials. Financial incentives may promote clinical trial enrollment, however delivery methods to maximize enrollment, maximize retention, and minimize cost remains uncertain. METHODS: We conducted a single-blind, web-based randomized controlled trial of five financial incentive strategies on enrollment and retention rates in a longitudinal study of advance directives among community-dwelling older adults. Participants were eligible to receive a fixed total financial incentive, but the disbursement amounts at each study timepoint (baseline, 2-weeks, 4-weeks, and 6-weeks) differed between study arms. At each timepoint, participants completed a different advance directive. We conducted an intention-to-treat analysis for the primary and secondary outcomes of enrollment and retention. RESULTS: 1803 adults were randomized to one of five incentive strategies: constant n = 361; increasing n = 357; U-shaped n = 361; surprise n = 360; self-select n = 364. Overall, 989 (54.9%) participants elected to enroll in the advance directive study. There were no differences in enrollment rates between the control (constant 53.5%) and any of the four intervention study arms (increasing 54.3%, p = 0.81; U-shaped 57.3%, p = 0.30; surprise 56.9%, p = 0.35; and self-select 52.2%, p = 0.73). There were no differences in retention rates between the control (constant 2.1%) and any of the four intervention study arms (increasing 5.2%, p = 0.09; U-shaped 3.9%, p = 0.23; surprise 2.4%, p = 0.54; self-select 2.1%, p = 0.63). CONCLUSIONS: Financial incentive programs for trial enrollment informed by behavioral economic insights were no more effective than a constant-payment approach in this web-based pilot study.

Randomized evaluation of trial acceptability by INcentive (RETAIN): Study protocol for two embedded randomized controlled trials.

INTRODUCTION: The most common and conceptually sound ethical concerns with financial incentives for research participation are that they may (1) represent undue inducements by blunting peoples' perceptions of research risks, thereby preventing fully informed consent; or (2) represent unjust inducements by encouraging enrollment preferentially among the poor. Neither of these concerns has been shown to manifest in studies testing the effects of incentives on decisions to participate in hypothetical randomized clinical trials (RCTs), but neither has been assessed in real RCTs. METHODS AND ANALYSES: We are conducting randomized trials of real incentives embedded within two parent RCTs. In each of two trials conducted in parallel, we are randomizing 576 participants to one of three incentive groups. Following preliminary determination of patients' eligibility in the parent RCT, we assess patients' research attitudes, demographic characteristics, perceived research risks, time spent reviewing consent documents, ability to distinguish research from patient care, and comprehension of key trial features. These quantitative assessments will be supplemented by semi-structured interviews for a selected group of participants that more deeply explore patients' motivations for trial participation. The trials are each designed to have adequate power to rule out undue and unjust inducement. We are also exploring potential benefits of incentives, including possible increased attention to research risks and cost-effectiveness.

Lung transplantation from donation after cardiocirculatory death: a systematic review and meta-analysis.

BACKGROUND: Lung transplantation (LTx) can extend life expectancy and enhance the quality of life for select patients with end-stage lung disease. In the setting of donor lung shortage and waiting list mortality, the interest in donation after cardiocirculatory death (DCD) is increasing. We performed a systematic review and meta-analysis to compare outcomes between DCD and conventional donation after brain death (DBD). METHODS: PubMed, CINAHL, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, Scopus, Web of Science, and ClinicalTrials.gov were searched. We identified original research studies with 1-year post-transplant survival data involving >5 DCD transplants. We performed meta-analyses examining 1-year survival, primary graft dysfunction, and acute rejection after LTx. RESULTS: We identified 519 citations; 11 observational cohort studies met our inclusion criteria for systematic review, and 6 met our inclusion criteria for meta-analysis. There were no differences found in 1-year mortality after LTx between DCD and DBD cohorts in individual studies or in the meta-analysis (DCD [n = 271] vs DBD [n = 2,369], relative risk [RR] 0.88, 95% confidence interval [CI] 0.59-1.31, p = 0.52, I(2) = 0%). There was also no difference between DCD and DBD in a pooled analysis of 5 studies reporting on primary graft dysfunction (RR 1.09, 95% CI 0.68-1.73, p = 0.7, I(2) = 0%) and 4 studies reporting on acute rejection (RR 0.72, 95% CI 0.49-1.05, p = 0.09, I(2) = 0%). CONCLUSIONS: Survival after LTx from DCD is comparable to survival after LTx from DBD in observational cohort studies. DCD appears to be a safe and effective method to expand the donor pool.