The Patient Perspective on Colectomy for Recurrent Diverticulitis: A Qualitative Study.

OBJECTIVE: Understand the patient's decision-making process regarding colectomy for recurrent diverticulitis. BACKGROUND: The decision to pursue elective colectomy for recurrent diverticulitis is highly preference-sensitive. Little is known about the patient's perspective in this decision-making process. METHODS: We performed a qualitative study utilizing focus groups of patients with recurrent diverticulitis at 3 centers across the United States. Using an iterative inductive/deductive approach, we developed a conceptual framework to capture the major themes identified in the coded data. RESULTS: From March 2019 to July 2020, 39 patients were enrolled across 3 sites and participated in 6 focus groups. After coding the transcripts using a hierarchical coding system, a conceptual framework was developed. Major themes identified included participants' beliefs about surgery, such as normative beliefs (eg, subjective, value placed on surgery), control beliefs (eg, self-efficacy, stage of change), and anticipated outcomes (eg, expectations, anticipated regret); the role of behavioral management strategies (eg, fiber, eliminate bad habits); emotional experiences (eg, depression, embarrassment); current symptoms (eg, severity, timing); and quality of life (eg, cognitive load, psychosocial factors). Three sets of moderating factors influencing patient choice were identified: clinical history (eg, source of diagnosis, multiple surgeries), clinical protocols (eg, pre-op and post-op education), and provider-specific factors (eg, specialty, choice of surgeon). CONCLUSIONS: Patients view the decision to undergo colectomy through 3 major themes: their beliefs about surgery, their psychosocial context, and moderating factors that influence participant choice to undergo surgery. This knowledge is essential both for clinicians counseling patients who are considering colectomy and for researchers studying the process to optimize care for recurrent diverticulitis.

Framework of the strengths and challenges of clinically integrated trials: An expert panel report.

The limitations of the explanatory clinical trial framework include the high expense of implementing explanatory trials, restrictive entry criteria for participants, and redundant logistical processes. These limitations can result in slow evidence generation that is not responsive to population health needs, yielding evidence that is not generalizable. Clinically integrated trials, which integrate clinical research into routine care, represent a potential solution to this challenge and an opportunity to support learning health systems. The operational and design features of clinically integrated trials include a focused scope, simplicity in design and requirements, the leveraging of existing data structures, and patient participation in the entire trial process. These features are designed to minimize barriers to participation and trial execution and reduce additional research burdens for participants and clinicians alike. Broad adoption and scalability of clinically integrated trials are dependent, in part, on continuing regulatory, healthcare system, and payer support. This analysis presents a framework of the strengths and challenges of clinically integrated trials and is based on a multidisciplinary expert "Think Tank" panel discussion that included representatives from patient populations, academia, non-profit funding agencies, the U.S. Food and Drug Administration, and industry.

Good Friends and Good Neighbors: Social Capital and Food Insecurity in Families with Newborns.

OBJECTIVE: To examine the association between social capital and household food insecurity among US families with newborns. STUDY DESIGN: This cross-sectional analysis used enrollment data from 881 newborn-caregiver dyads at six geographically-diverse US academic sites enrolled in the Greenlight Plus Trial, a comparative effectiveness trial to prevent childhood obesity. Ordinal proportional-odds models were used to characterize the associations of two self-reported measures of social capital: 1) caregiver social support and 2) neighborhood social cohesion, with household food insecurity after controlling for sociodemographic characteristics. RESULTS: Among 881 newborn-caregiver dyads (49% Hispanic, 23% non-Hispanic white, 17% non-Hispanic Black; 49% with annual household income <$50,000), food security was high for 75%, marginal for 9%, low for 11% and very low for 4%. In covariate-adjusted analyses, caregivers with a low social support score of 18 had five times the odds (aOR=5.03 95%CI=3.28-7.74) of greater food insecurity compared with caregivers with a high social support score of 30. Caregivers with a low neighborhood social cohesion score of 10 had nearly three times the odds (aOR=2.87 95%CI 1.61-5.11) of greater food insecurity compared with caregivers with a high neighborhood social cohesion score of 20. These associations remained robust when both social capital measures were included in one model. CONCLUSIONS: Caregiver social support and neighborhood social cohesion each appear to be inversely associated with food insecurity among US families with newborns. Longitudinal research is needed to determine the directionality of these relationships and whether improving social capital for families with young children reduces household food insecurity.

Comparison of the effectiveness and safety of 2 aspirin doses in secondary prevention of cardiovascular outcomes in patients with chronic kidney disease: A subgroup analysis of ADAPTABLE.

BACKGROUND: Among patients with established cardiovascular disease, the ADAPTABLE trial found no significant differences in cardiovascular events and bleeding rates between 81 mg and 325 mg of aspirin (ASA) daily. In this secondary analysis from the ADAPTABLE trial, we studied the effectiveness and safety of ASA dosing in patients with a history of chronic kidney disease (CKD). METHODS: ADAPTABLE participants were stratified based on the presence or absence of CKD, defined using ICD-9/10-CM codes. Within the CKD group, we compared outcomes between patients taking ASA 81 mg and 325 mg. The primary effectiveness outcome was defined as a composite of all cause death, myocardial infarction, or stroke and the primary safety outcome was hospitalization for major bleeding. Adjusted Cox proportional hazard models were utilized to report differences between the groups. RESULTS: After excluding 414 (2.7%) patients due to missing medical history, a total of 14,662 patients were included from the ADAPTABLE cohort, of whom 2,648 (18%) patients had CKD. Patients with CKD were older (median age 69.4 vs 67.1 years; P < .0001) and less likely to be white (71.5% vs 81.7%; P < .0001) when compared to those without CKD. At a median follow-up of 26.2 months, CKD was associated with an increased risk of both the primary effectiveness outcome (adjusted HR 1.79 [1.57, 2.05] P < .001 and the primary safety outcome (adjusted HR 4.64 (2.98, 7.21), P < .001 and P < .05, respectively) regardless of ASA dose. There was no significant difference in effectiveness (adjusted HR 1.01 95% CI 0.82, 1.23; P = .95) or safety (adjusted HR 0.93; 95% CI 0.52, 1.64; P = .79) between ASA groups. CONCLUSIONS: Patients with CKD were more likely than those without CKD to have adverse cardiovascular events or death and were also more likely to have major bleeding requiring hospitalization. However, there was no association between ASA dose and study outcomes among these patients with CKD.

Avenues for Strengthening PCORnet's Capacity to Advance Patient-Centered Economic Outcomes in Patient-Centered Outcomes Research (PCOR).

PCORnet, the National Patient-Centered Clinical Research Network, provides the ability to conduct prospective and observational pragmatic research by leveraging standardized, curated electronic health records data together with patient and stakeholder engagement. PCORnet is funded by the Patient-Centered Outcomes Research Institute (PCORI) and is composed of 8 Clinical Research Networks that incorporate at total of 79 health system "sites." As the network developed, linkage to commercial health plans, federal insurance claims, disease registries, and other data resources demonstrated the value in extending the networks infrastructure to provide a more complete representation of patient's health and lived experiences. Initially, PCORnet studies avoided direct economic comparative effectiveness as a topic. However, PCORI's authorizing law was amended in 2019 to allow studies to incorporate patient-centered economic outcomes in primary research aims. With PCORI's expanded scope and PCORnet's phase 3 beginning in January 2022, there are opportunities to strengthen the network's ability to support economic patient-centered outcomes research. This commentary will discuss approaches that have been incorporated to date by the network and point to opportunities for the network to incorporate economic variables for analysis, informed by patient and stakeholder perspectives. Topics addressed include: (1) data linkage infrastructure; (2) commercial health plan partnerships; (3) Medicare and Medicaid linkage; (4) health system billing-based benchmarking; (5) area-level measures; (6) individual-level measures; (7) pharmacy benefits and retail pharmacy data; and (8) the importance of transparency and engagement while addressing the biases inherent in linking real-world data sources.

Racial/Ethnic Disparities in Post-acute Sequelae of SARS-CoV-2 Infection in New York: an EHR-Based Cohort Study from the RECOVER Program.

BACKGROUND: Compared to white individuals, Black and Hispanic individuals have higher rates of COVID-19 hospitalization and death. Less is known about racial/ethnic differences in post-acute sequelae of SARS-CoV-2 infection (PASC). OBJECTIVE: Examine racial/ethnic differences in potential PASC symptoms and conditions among hospitalized and non-hospitalized COVID-19 patients. DESIGN: Retrospective cohort study using data from electronic health records. PARTICIPANTS: 62,339 patients with COVID-19 and 247,881 patients without COVID-19 in New York City between March 2020 and October 2021. MAIN MEASURES: New symptoms and conditions 31-180 days after COVID-19 diagnosis. KEY RESULTS: The final study population included 29,331 white patients (47.1%), 12,638 Black patients (20.3%), and 20,370 Hispanic patients (32.7%) diagnosed with COVID-19. After adjusting for confounders, significant racial/ethnic differences in incident symptoms and conditions existed among both hospitalized and non-hospitalized patients. For example, 31-180 days after a positive SARS-CoV-2 test, hospitalized Black patients had higher odds of being diagnosed with diabetes (adjusted odds ratio [OR]: 1.96, 95% confidence interval [CI]: 1.50-2.56, q<0.001) and headaches (OR: 1.52, 95% CI: 1.11-2.08, q=0.02), compared to hospitalized white patients. Hospitalized Hispanic patients had higher odds of headaches (OR: 1.62, 95% CI: 1.21-2.17, q=0.003) and dyspnea (OR: 1.22, 95% CI: 1.05-1.42, q=0.02), compared to hospitalized white patients. Among non-hospitalized patients, Black patients had higher odds of being diagnosed with pulmonary embolism (OR: 1.68, 95% CI: 1.20-2.36, q=0.009) and diabetes (OR: 2.13, 95% CI: 1.75-2.58, q<0.001), but lower odds of encephalopathy (OR: 0.58, 95% CI: 0.45-0.75, q<0.001), compared to white patients. Hispanic patients had higher odds of being diagnosed with headaches (OR: 1.41, 95% CI: 1.24-1.60, q<0.001) and chest pain (OR: 1.50, 95% CI: 1.35-1.67, q < 0.001), but lower odds of encephalopathy (OR: 0.64, 95% CI: 0.51-0.80, q<0.001). CONCLUSIONS: Compared to white patients, patients from racial/ethnic minority groups had significantly different odds of developing potential PASC symptoms and conditions. Future research should examine the reasons for these differences.

Qualitative similarities and distinctions between participants' experiences with a yoga intervention and an attention control.

PURPOSE: This manuscript aims to compare and contrast acceptability and perceived benefits of yoga-skills training (YST) and an empathic listening attention control (AC) in the Pro-You study, a randomized pilot trial of YST vs. AC for adults receiving chemotherapy infusions for gastrointestinal cancer. METHODS: Participants were invited for a one-on-one interview at week 14 follow-up, after completing all intervention procedures and quantitative assessments. Staff used a semi-structured guide to elicit participants' views on study processes, the intervention they received, and its effects. Qualitative data analysis followed an inductive/deductive approach, inductively identifying themes and deductively guided by social cognitive theory. RESULTS: Some barriers (e.g., competing demands, symptoms), facilitators (e.g., interventionist support, the convenience of clinic-based delivery), and benefits (e.g., decreased distress and rumination) were common across groups. YST participants uniquely described the importance of privacy, social support, and self-efficacy for increasing engagement in yoga. Benefits specific to YST included positive emotions and greater improvement in fatigue and other physical symptoms. Both groups described some self-regulatory processes, but through different mechanisms: self-monitoring in AC and the mind-body connection in YST. CONCLUSIONS: This qualitative analysis demonstrates that participant experiences in a yoga-based intervention or an AC condition reflect social cognitive and mind-body frameworks of self-regulation. Findings can be used to develop yoga interventions that maximize acceptability and effectiveness and to design future research that elucidates the mechanisms by which yoga is efficacious.

Effect of Higher-Dose Ivermectin for 6 Days vs Placebo on Time to Sustained Recovery in Outpatients With COVID-19: A Randomized Clinical Trial.

Importance: It is unknown whether ivermectin, with a maximum targeted dose of 600 µg/kg, shortens symptom duration or prevents hospitalization among outpatients with mild to moderate COVID-19. Objective: To evaluate the effectiveness of ivermectin at a maximum targeted dose of 600 µg/kg daily for 6 days, compared with placebo, for the treatment of early mild to moderate COVID-19. Design, Setting, and Participants: The ongoing Accelerating COVID-19 Therapeutic Interventions and Vaccines 6 (ACTIV-6) platform randomized clinical trial was designed to evaluate repurposed therapies among outpatients with mild to moderate COVID-19. A total of 1206 participants older than 30 years with confirmed COVID-19 experiencing at least 2 symptoms of acute infection for less than or equal to 7 days were enrolled at 93 sites in the US from February 16, 2022, through July 22, 2022, with follow-up data through November 10, 2022. Interventions: Participants were randomly assigned to receive ivermectin, with a maximum targeted dose of 600 µg/kg (n = 602) daily, or placebo (n = 604) for 6 days. Main Outcomes and Measures: The primary outcome was time to sustained recovery, defined as at least 3 consecutive days without symptoms. The 7 secondary outcomes included a composite of hospitalization, death, or urgent/emergent care utilization by day 28. Results: Among 1206 randomized participants who received study medication or placebo, the median (IQR) age was 48 (38-58) years, 713 (59.1%) were women, and 1008 (83.5%) reported receiving at least 2 SARS-CoV-2 vaccine doses. The median (IQR) time to sustained recovery was 11 (11-12) days in the ivermectin group and 11 (11-12) days in the placebo group. The hazard ratio (posterior probability of benefit) for improvement in time to recovery was 1.02 (95% credible interval, 0.92-1.13; P = .68). Among those receiving ivermectin, 34 (5.7%) were hospitalized, died, or had urgent or emergency care visits compared with 36 (6.0%) receiving placebo (hazard ratio, 1.0 [95% credible interval, 0.6-1.5]; P = .53). In the ivermectin group, 1 participant died and 4 were hospitalized (0.8%); 2 participants (0.3%) were hospitalized in the placebo group and there were no deaths. Adverse events were uncommon in both groups. Conclusions and Relevance: Among outpatients with mild to moderate COVID-19, treatment with ivermectin, with a maximum targeted dose of 600 µg/kg daily for 6 days, compared with placebo did not improve time to sustained recovery. These findings do not support the use of ivermectin in patients with mild to moderate COVID-19. Trial Registration: ClinicalTrials.gov Identifier: NCT04885530.

Higher-Dose Fluvoxamine and Time to Sustained Recovery in Outpatients With COVID-19: The ACTIV-6 Randomized Clinical Trial.

Importance: The effect of higher-dose fluvoxamine in reducing symptom duration among outpatients with mild to moderate COVID-19 remains uncertain. Objective: To assess the effectiveness of fluvoxamine, 100 mg twice daily, compared with placebo, for treating mild to moderate COVID-19. Design, Setting, and Participants: The ACTIV-6 platform randomized clinical trial aims to evaluate repurposed medications for mild to moderate COVID-19. Between August 25, 2022, and January 20, 2023, a total of 1175 participants were enrolled at 103 US sites for evaluating fluvoxamine; participants were 30 years or older with confirmed SARS-CoV-2 infection and at least 2 acute COVID-19 symptoms for 7 days or less. Interventions: Participants were randomized to receive fluvoxamine, 50 mg twice daily on day 1 followed by 100 mg twice daily for 12 additional days (n = 601), or placebo (n = 607). Main Outcomes and Measures: The primary outcome was time to sustained recovery (defined as at least 3 consecutive days without symptoms). Secondary outcomes included time to death; time to hospitalization or death; a composite of hospitalization, urgent care visit, emergency department visit, or death; COVID-19 clinical progression scale score; and difference in mean time unwell. Follow-up occurred through day 28. Results: Among 1208 participants who were randomized and received the study drug, the median (IQR) age was 50 (40-60) years, 65.8% were women, 45.5% identified as Hispanic/Latino, and 76.8% reported receiving at least 2 doses of a SARS-CoV-2 vaccine. Among 589 participants who received fluvoxamine and 586 who received placebo included in the primary analysis, differences in time to sustained recovery were not observed (adjusted hazard ratio [HR], 0.99 [95% credible interval, 0.89-1.09]; P for efficacy = .40]). Additionally, unadjusted median time to sustained recovery was 10 (95% CI, 10-11) days in both the intervention and placebo groups. No deaths were reported. Thirty-five participants reported health care use events (a priori defined as death, hospitalization, or emergency department/urgent care visit): 14 in the fluvoxamine group compared with 21 in the placebo group (HR, 0.69 [95% credible interval, 0.27-1.21]; P for efficacy = .86) There were 7 serious adverse events in 6 participants (2 with fluvoxamine and 4 with placebo) but no deaths. Conclusions and Relevance: Among outpatients with mild to moderate COVID-19, treatment with fluvoxamine does not reduce duration of COVID-19 symptoms. Trial Registration: ClinicalTrials.gov Identifier: NCT04885530.

National Variation in Elective Colon Resection for Diverticular Disease.

OBJECTIVE: This study aims to characterize the extent of geographic variation in elective sigmoid resection for diverticulitis and to identify factors associated with observed variation. INTRODUCTION: National guidelines for treatment of recurrent diverticulitis fail to offer strong recommendations for or against surgical intervention. We hypothesize that healthcare market factors will be significantly associated with geographic variation in colon resection for diverticulitis, a discretionary surgical intervention. METHODS: We used Center for Medicare Services 100% inpatient Limited Data Set (LDS) files from January 2013 through September 2015 to calculate an observed to expected standardized colon resection ratio for each hospital referral region (HRR). We then analyzed patient, hospital-, and market-level factors associated with variation of colectomy. For each HRR, a Herfindahl-Hirschman index, a measure of market competition, was calculated. RESULTS: A total of 19,557 Medicare patients underwent an elective colon resection for diverticulitis at 2462 hospitals over the study period. Standardized colon resection ratios ranged from 0 in the Tuscaloosa HRR to 3.7 in the Royal Oak, MI HRR. Few patient factors were associated with variation, but a number of hospital factors (size, area, profit status, and critical access designation) all were associated with variation. In an analysis of market factors, increased surgeon density, and decreased market competition were associated with higher predicted rates of colon resection. CONCLUSION: We observed pronounced variation (excess of 3-fold) in standardized colon resection ratios for recurrent diverticulitis. Surgeon density and hospital level factors were strongly associated with this variation and may be the main drivers of colonic resection for diverticular disease. Further investigation and stronger national guidelines are needed to optimize patient selection for colectomy.

Benchmarking patient satisfaction scores in a colorectal patient population.

BACKGROUND: Healthcare reimbursement is rapidly moving away from a fee-for-service model toward value-based purchasing. An integral component of this new focus on quality is patient-centered outcomes. One metric used to define patient satisfaction is the Press Ganey Patient Satisfaction Survey. Data are lacking to accurately benchmark these scores based on diagnosis. We sought to identify if different colorectal disease processes affected a patient's perception of their healthcare experience. METHODS: Adult colorectal patients seen between July 2015 and September 2016 in a tertiary hospital colorectal clinic were mailed a Press Ganey survey. Patients were stratified based on diagnosis: neoplasia, IBD, anorectal and benign colorectal disease. Survey scores were compared across the groups with adjustment for confounding variables. RESULTS: 312 patients responded and formed the cohort. The mean age was 61 (range 18-93) and 56% were women. The cohort breakdown was 38% neoplasia, 32% anorectal, 21% benign, and 9% IBD. In a multivariable model, there was a difference in PG scores by diagnosis; patients with neoplasia had higher Overall scores (ß 10.2; Std Error 4.0; p = 0.01), Care Provider scores (ß 8.5; Std Error 4.2; p = 0.04), Nurse Assistant scores (ß 15.0; Std Error 5.7; p = 0.01), and Personal Issues scores (ß 11.8; Std Error 5/0; p = 0.01). CONCLUSION: Press Ganey scores were found to vary significantly. Patients with a neoplasia diagnosis reported higher overall satisfaction, Care Provider, Nurse Assistant, and Personal Issues scores. Adjustment for disease condition is important when assessing patient satisfaction as an indicator of quality and as a metric for reimbursement. This study adds to increasing evidence about bias in these scores.

The Partnership to Improve Diabetes Education Trial: a Cluster Randomized Trial Addressing Health Communication in Diabetes Care.

BACKGROUND: Effective type 2 diabetes care remains a challenge for patients including those receiving primary care in safety net settings. OBJECTIVE: The Partnership to Improve Diabetes Education (PRIDE) trial team and leaders from a regional department of health evaluated approaches to improve care for vulnerable patients. DESIGN: Cluster randomized controlled trial. PATIENTS: Adults with uncontrolled type 2 diabetes seeking care across 10 unblinded, randomly assigned safety net clinics in Middle TN. INTERVENTIONS: A literacy-sensitive, provider-focused, health communication intervention (PRIDE; 5 clinics) vs. standard diabetes education (5 clinics). MAIN MEASURES: Participant-level primary outcome was glycemic control [A1c] at 12 months. Secondary outcomes included select health behaviors and psychosocial aspects of care at 12 and 24 months. Adjusted mixed effects regression models were used to examine the comparative effectiveness of each approach to care. KEY RESULTS: Of 410 patients enrolled, 364 (89%) were included in analyses. Median age was 51 years; Black and Hispanic patients represented 18% and 25%; 96% were uninsured, and 82% had low annual income level (< $20,000); adequate health literacy was seen in 83%, but numeracy deficits were common. At 12 months, significant within-group treatment effects occurred from baseline for both PRIDE and control sites: adjusted A1c (- 0.76 [95% CI, - 1.08 to - 0.44]; P < .001 vs - 0.54 [95% CI, - 0.86 to - 0.21]; P = .001), odds of poor eating (0.53 [95% CI, 0.33-0.83]; P = .01 vs 0.42 [95% CI, 0.26-0.68]; P < .001), treatment satisfaction (3.93 [95% CI, 2.48-6.21]; P < .001 vs 3.04 [95% CI, 1.93-4.77]; P < .001), and self-efficacy (2.97 [95% CI, 1.89-4.67]; P < .001 vs 1.81 [95% CI, 1.1-2.84]; P = .01). No significant difference was observed between study arms in adjusted analyses. CONCLUSIONS: Both interventions improved the participant's A1c and behavioral outcomes. PRIDE was not more effective than standard education. Further research may elucidate the added value of a focused health communication program in this setting.

Patient-Reported Outcome Measures in Colon and Rectal Surgery: A Systematic Review and Quality Assessment.

BACKGROUND: There is growing interest in using patient-reported outcome measures to support value-based care in colorectal surgery. To draw valid conclusions regarding patient-reported outcomes data, measures with robust measurement properties are required. OBJECTIVE: The purpose of this study was to assess the use and quality of patient-reported outcome measures in colorectal surgery. DATA SOURCES: Three major databases were searched for studies using patient-reported outcome measures in the context of colorectal surgery. STUDY SELECTION: Articles that used patient-reported outcome measures as outcome for colorectal surgical intervention in a comparative effectiveness analysis were included. Exclusion criteria included articles older than 11 years, non-English language, age <18 years, fewer than 40 patients, case reports, review articles, and studies without comparison. MAIN OUTCOME MEASURES: This was a quality assessment using a previously reported checklist of psychometric properties. RESULTS: From 2007 to 2018, 368 studies were deemed to meet inclusion criteria. These studies used 165 distinct patient-reported outcome measures. Thirty were used 5 or more times and were selected for quality assessment. Overall, the measures were generally high quality, with 21 (70%) scoring ≥14 on an 18-point scale. Notable weaknesses included management of missing data (14%) and description of literacy level (0%). LIMITATIONS: The study was limited by its use of original articles for quality assessment. Measures were selected for quality analysis based on frequency of use rather than other factors, such as impact of the article or number of patients in the study. CONCLUSIONS: Patient-reported outcome measures are widely used in colorectal research. There was a wide range of measures available, and many were used only once. The most frequently used measures are generally high quality, but a majority lack details on how to deal with missing data and information on literacy levels. As the use of patient-reported outcome measures to assess colorectal surgical intervention increases, researchers and practitioners need to become more knowledgeable about the measures available and their quality.

Assessing Diet Quality in a Racially and Ethnically Diverse Cohort of Low-income Toddlers.

BACKGROUND: Low-income racially and ethnically diverse children are at higher risk for obesity compared with their counterparts; yet, few studies have assessed their diet quality. OBJECTIVE: The aim of the study was to evaluate the diet quality of a racially and ethnically diverse cohort of 2-year-olds using the Healthy Eating Index (HEI)-2010. METHODS: We used 24-hour dietary recall data from caregivers of toddlers (24-34 months) at 4 pediatric resident clinics that participated in the Greenlight Study to calculate compliance with the Dietary Guidelines for Americans (DGA) using total HEI score (range 0-100) and 12 component scores. RESULTS: Participants (n = 231) were mostly Hispanic (57%) or non-Hispanic black (27%) and from low-income families. Mean HEI-2010 score was 62.8 (standard deviation [SD] 10.5). Though not significant, Hispanics had the highest HEI score. Toddlers of caregivers without obesity, older than 35 years and born outside the United States had higher HEI scores. Most had high HEI component scores for dairy, fruit, and protein foods, but few achieved maximum scores, particularly for whole grains (13%), vegetables (10%), and fatty acid ratio (7%). CONCLUSIONS: Despite scores reflective of DGA recommendations for fruit, dairy and protein foods, toddlers in this diverse sample had low quality diets as measured by the HEI, driven largely by low component scores for whole grains, vegetables, and ratio of unsaturated to saturated fatty acids.

Relationship Between Parental Locus of Control and Childhood Injury.

Although pediatricians routinely counsel parents about preventing childhood injuries, we know little about parents' locus of control (LOC) in regards to preventing their children from being injured. We performed an observational analysis of sociodemographic differences in LOC for injury prevention, as measured by four items adapted from the Parental Health Beliefs Scales, in English- and Spanish-speaking parents of infants participating in the treatment arm of an obesity prevention study. First, we examined associations of parental LOC for injury prevention at the time their children were 2 months old with parents' age, race/ethnicity, income, and education. Next, we analyzed time trends for repeated LOC measures when the children were 2, 6, 9, 12, and 24 months old. Last, we examined the association between injury-related LOC items and children's injury (yes/no) at each time point. Of 452 parents, those with lower incomes had both lower internal and higher external LOC. Lower educational achievement was associated with higher external LOC. Both internal and external LOC scores decreased over time. Injuries were more common in children whose parents endorsed low internal and high external LOC. Future studies should examine whether primary care-based interventions can increase parents' sense of control over their children's safety and whether that, in turn, is associated with lower injury rates.Clinical Trial Registration: NCT01040897.

Association of Health Literacy and Numeracy with Interest in Research Participation.

BACKGROUND: There is much attention to recruitment of diverse populations in research, but little is known about the influence of health literacy and numeracy skills. OBJECTIVE: To determine if health literacy and numeracy affect individuals' interest to participate in research studies. DESIGN: Cross-sectional survey data were pooled from 3 large studies conducted in the Mid-South Clinical Data Research Network. PARTICIPANTS: Adult patients enrolled in 1 of 3 Mid-South Clinical Data Research Network studies. MAIN MEASURES: The survey domains included demographic items, the 3-item Brief Health Literacy Screen (range 3-15), and the 3-item Subjective Numeracy Scale (range 3-18). The outcome was a sum index measure of a 7-item instrument (range 7-21) assessing individuals' interest in participating in different types of research, including research that involves taking surveys, giving a blood sample, participating via phone or internet, taking an investigational medication, meeting at a local community center or school, including family, or staying overnight at a hospital. KEY RESULTS: Respondents (N = 15,973) were predominately women (65.5%), White (81.4%), and middle aged (M = 52.8 years, SD = 16.5); 32.4% previously participated in research. Self-reported health literacy was relatively high (M = 13.5 out of 15, SD = 2.1), and subjective numeracy skills were somewhat lower (M = 14.3 out of 18, SD = 3.6). After adjustment for age, gender, race, income, education, and other characteristics, lower health literacy and numeracy skills were each independently associated with less interest in research participation (p < 0.001 for each). Prior research participation was associated with greater interest in future research participation (p < 0.001). CONCLUSIONS: After adjustment for factors known to be predictive of interest, individuals with lower health literacy or numeracy scores were less interested in participating in research. Additional work is needed to elucidate reasons for this finding and to determine strategies to engage these populations.

Maintaining automated measurement of Choosing Wisely adherence across the ICD 9 to 10 transition.

BACKGROUND: It remains unclear how to incorporate terminology changes, such as the International Classification of Disease (ICD) transition from ICD-9 to ICD-10, into established automated healthcare quality metrics. OBJECTIVE: To evaluate whether general equivalence mapping (GEM) can apply ICD-9 based metrics to ICD-10 patient data. To develop and validate novel ICD-10 reference codesets. DESIGN: Retrospective analysis for eleven Choosing Wisely (CW) metrics was performed using three scripted algorithms on an institutional clinical data warehouse. ICD-10 data were compared against published ICD-9 based metric definitions using two equivalence mapping algorithms. A third algorithm implemented novel reference ICD-10 codes matching the original ICD-9 codes' intent for comparison with patient ICD-10 data. PARTICIPANTS: All adult patients seen at Vanderbilt University Medical Center, April - September 2016. MAIN MEASURES: The prevalence of eleven CW services during the six-month period. KEY RESULTS: The three algorithms found similar prevalence of avoidable CW services, with an unweighted-mean of 8.4% (range: 0.16-65%), or approximately 20,000 CW services out of 240,000 potential cases in 515,406 unique patients. The algorithms' median sensitivity was 0.80 (interquartile range: 0.75-0.95), median specificity was 0.88 (IQR: 0.77-0.94), and median Rand accuracy was 0.84 (IQR: 0.79-0.89). The attributed waste of these eleven services for the period ranged from $871,049 to $951,829 between methods. Accuracy assessment demonstrated that the GEM-based methods suffered recall losses for metrics requiring multistep mapping due to incompleteness, while novel ICD-10 metric definitions avoided these challenges. CONCLUSIONS: Comprehensive mapping enables use of legacy metrics across ICD generations, but requires computational complexity that can be avoided with novel ICD-10 based metric definitions. Variation in the dollars attributed to waste due to ICD mapping introduces ambiguity that may affect quality-based reimbursement.

Performance of a computable phenotype for identification of patients with diabetes within PCORnet: The Patient-Centered Clinical Research Network.

PURPOSE: PCORnet, the National Patient-Centered Clinical Research Network, represents an innovative system for the conduct of observational and pragmatic studies. We describe the identification and validation of a retrospective cohort of patients with type 2 diabetes (T2DM) from four PCORnet sites. METHODS: We adapted existing computable phenotypes (CP) for the identification of patients with T2DM and evaluated their performance across four PCORnet sites (2012-2016). Patients entered the cohort on the earliest date they met one of three CP categories: (CP1) coded T2DM diagnosis (ICD-9/ICD-10) and an antidiabetic prescription, (CP2) diagnosis and glycosylated hemoglobin (HbA1c) ≥6.5%, or (CP3) an antidiabetic prescription and HbA1c ≥6.5%. We required evidence of health care utilization in each of the 2 prior years for each patient, as we also developed an incident T2DM CP to identify the subset of patients without documentation of T2DM in the 365 days before t0 . Among a systematic sample of patients, we calculated the positive predictive value (PPV) for the T2DM CP and incident-T2DM CP using electronic health record (EHR) review as reference. RESULTS: The CP identified 50 657 patients with T2DM. The PPV of patients randomly selected for validation was 96.2% (n = 1572; CI:95.1-97.0) and was consistently high across sites. The PPV for the incident-T2DM CP was 5.8% (CI:4.5-7.5). CONCLUSIONS: The T2DM CP accurately and efficiently identified patients with T2DM across multiple sites that participate in PCORnet, although the incident T2DM CP requires further study. PCORnet is a valuable data source for future epidemiological and comparative effectiveness research among patients with T2DM.

Leveraging electronic health records for clinical research.

Electronic health records (EHRs) can be a major tool in the quest to decrease costs and timelines of clinical trial research, generate better evidence for clinical decision making, and advance health care. Over the past decade, EHRs have increasingly offered opportunities to speed up, streamline, and enhance clinical research. EHRs offer a wide range of possible uses in clinical trials, including assisting with prestudy feasibility assessment, patient recruitment, and data capture in care delivery. To fully appreciate these opportunities, health care stakeholders must come together to face critical challenges in leveraging EHR data, including data quality/completeness, information security, stakeholder engagement, and increasing the scale of research infrastructure and related governance. Leaders from academia, government, industry, and professional societies representing patient, provider, researcher, industry, and regulator perspectives convened the Leveraging EHR for Clinical Research Now! Think Tank in Washington, DC (February 18-19, 2016), to identify barriers to using EHRs in clinical research and to generate potential solutions. Think tank members identified a broad range of issues surrounding the use of EHRs in research and proposed a variety of solutions. Recognizing the challenges, the participants identified the urgent need to look more deeply at previous efforts to use these data, share lessons learned, and develop a multidisciplinary agenda for best practices for using EHRs in clinical research. We report the proceedings from this think tank meeting in the following paper.

Measuring Health Literacy Among Adults with HIV Infection in Mozambique: Development and Validation of the HIV Literacy Test.

The role of health literacy on HIV outcomes has not been evaluated widely in Africa, in part because few appropriate literacy measures exist. We developed a 16-item scale, the HIV Literacy Test (HIV-LT) to assess literacy-related tasks needed to participate in HIV care. Items were scored as correct or incorrect; higher scores indicated higher literacy skill (range 0-100 %). We tested internal reliability (Kuder-Richardson coefficient) of the HIV-LT in a convenience sample of 319 Portuguese-speaking, HIV infected adults on antiretroviral treatment in Maputo, Mozambique. Construct validity was assessed by a hypothetical model developed a priori. The HIV-LT was reliable and valid to measure participants' literacy skills. The mean HIV-LT score was 42 %; literacy skills applicable to HIV care were challenging for many participants. The HIV-LT could be used to assess the relationship of literacy and HIV-related outcomes in diverse settings, and evaluate interventions to improve health communication for those in HIV care.