Changing US Support for Public Health Data Use Through Pandemic and Political Turmoil.

Policy Points This study examines the impact of several world-changing events in 2020, such as the pandemic and widespread racism protests, on the US population's comfort with the use of identifiable data for public health. Before the 2020 election, there was no significant difference between Democrats and Republicans. However, African Americans exhibited a decrease in comfort that was different from other subgroups. Our findings suggest that the public remained supportive of public health data activities through the pandemic and the turmoil of 2020 election cycle relative to other data use. However, support among African Americans for public health data use experienced a unique decline compared to other demographic groups. CONTEXT: Recent legislative privacy efforts have not included special provisions for public health data use. Although past studies documented support for public health data use, several global events in 2020 have raised awareness and concern about privacy and data use. This study aims to understand whether the events of 2020 affected US privacy preferences on secondary uses of identifiable data, focusing on public health and research uses. METHODS: We deployed two online surveys-in February and November 2020-on data privacy attitudes and preferences using a choice-based-conjoint analysis. Participants received different data-use scenario pairs-varied by the type of data, user, and purpose-and selected scenarios based on their comfort. A hierarchical Bayes regression model simulated population preferences. FINDINGS: There were 1,373 responses. There was no statistically significant difference in the population's data preferences between February and November, each showing the highest comfort with population health and research data activities and the lowest with profit-driven activities. Most subgroups' data preferences were comparable with the population's preferences, except African Americans who showed significant decreases in comfort with population health and research. CONCLUSIONS: Despite world-changing events, including a pandemic, we found bipartisan public support for using identifiable data for public health and research. The decreasing support among African Americans could relate to the increased awareness of systemic racism, its harms, and persistent disparities. The US population's preferences support including legal provisions that permit public health and research data use in US laws, which are currently lacking specific public health use permissions.

Geographic disparities in telemedicine mental health use by applying three way ANOVA on Medicaid claims population data.

BACKGROUND: Utilization of telemedicine care for vulnerable and low income populations, especially individuals with mental health conditions, is not well understood. The goal is to describe the utilization and regional disparities of telehealth care by mental health status in Texas. Texas Medicaid claims data were analyzed from September 1, 2012, to August 31, 2018 for Medicaid patients enrolled due to a disability. METHODS: We analyzed the growth in telemedicine care based on urban, suburban, and rural, and mental health status. We used t-tests to test for differences in sociodemographic characteristics across patients and performed a three-way Analyses of Variance (ANOVA) to evaluate whether the growth rates from 2013 to 2018 were different based on geography and patient type. We then estimated patient level multivariable ordinary least square regression models to estimate the relationship between the use of telemedicine and patient characteristics in 2013 and separately in 2018. Outcome was a binary variable of telemedicine use or not. Independent variables of interest include geography, age, gender, race, ethnicity, plan type, Medicare eligibility, diagnosed mental health condition, and ECI score. RESULTS: Overall, Medicaid patients with a telemedicine visit grew at 81%, with rural patients growing the fastest (181%). Patients with a telemedicine visit for a mental health condition grew by 77%. Telemedicine patients with mental health diagnoses tended to have 2 to 3 more visits per year compared to non-telemedicine patients with mental health diagnoses. In 2013, multivariable regressions display that urban and suburban patients, those that had a mental health diagnosis were more likely to use telemedicine, while patients that were younger, women, Hispanics, and those dual eligible were less likely to use telemedicine. By 2018, urban and suburban patients were less likely to use telemedicine. CONCLUSIONS: Growth in telemedicine care was strong in urban and rural areas between 2013 and 2018 even before the COVID-19 pandemic. Those with a mental health condition who received telemedicine care had a higher number of total mental health visits compared to those without telemedicine care. These findings hold across all geographic groups and suggest that mental health telemedicine visits did not substitute for face-to-face mental health visits.

Healthcare Costs for Medicare Patients With Hepatocellular Carcinoma in the United States.

BACKGROUND & AIMS: Hepatocellular carcinoma (HCC) has an increasing mortality in the United States and is a leading cause of morbidity and mortality in patients with cirrhosis. We aimed to estimate the financial burden related to HCC in a large nationally representative United States cohort. METHODS: We used the Surveillance, Epidemiology, and End Results program (SEER)-Medicare database to identify 4525 adult patients who were diagnosed with HCC between 2011 and 2015. We generated a 1:1 propensity score-matched cohort of patients with cirrhosis but no HCC as a comparator group to define incremental HCC-specific costs beyond costs related to underlying cirrhosis. Our main outcomes were patient liabilities and Medicare payments in the first year after HCC diagnosis. RESULTS: Compared with patients with cirrhosis, those with HCC had higher incremental patient liabilities (median +$7166; interquartile range, $2401-$16,099) and Medicare payments (+$50,110; interquartile range, $142,42-$136,239; P < .001 for both) in the first year after diagnosis. Patients with HCC had significantly higher inpatient, outpatient, and physician service costs compared with the matched cohort with cirrhosis (P < .001 for all). Patients with early-stage HCC had lower incremental patient liabilities (median, $4195 vs $8238; P < .001) and Medicare payments (median, $28,207 vs $59,509; P < .001) than those with larger tumor burden. In multivariable median regression analysis, incremental patient liabilities and Medicare payments were significantly associated with the National Cancer Institute comorbidity index, nonalcoholic fatty liver disease etiology, presence of ascites, and presence of hepatic encephalopathy. CONCLUSIONS: Patients with HCC suffer from cancer-related financial burden, highlighting a need for policy interventions and financial support systems.

Clinical Characteristics and Outcomes of Nonalcoholic Fatty Liver Disease-Associated Hepatocellular Carcinoma in the United States.

BACKGROUND & AIMS: The extent to which nonalcoholic fatty liver disease (NAFLD) contributes to hepatocellular carcinoma (HCC) prevalence in contemporary practices and whether there are any etiologic differences in surveillance receipt, tumor stage, and overall survival (OS) remain unclear. We aimed to estimate the burden of NAFLD-related HCC and magnitude of associations with surveillance receipt, clinical presentation, and outcomes in a contemporary HCC cohort. METHODS: In a cohort of HCC patients from the Surveillance, Epidemiology and End Results-Medicare database between 2011 and 2015, we used multivariable logistic regression to identify factors associated with surveillance receipt, early-stage tumor detection, and curative treatment. Cox regression was used to identify factors associated with OS. RESULTS: Among 5098 HCC patients, NAFLD was the leading etiology, accounting for 1813 cases (35.6%). Compared with those with hepatitis C-related HCC, NAFLD was associated with lower HCC surveillance receipt (adjusted odds ratio, 0.22; 95% confidence interval [CI], 0.17-0.28), lower early-stage HCC detection (adjusted odds ratio, 0.49; 95% CI, 0.40-0.60), and modestly worse OS (adjusted hazard ratio, 1.20; 95% CI, 1.09-1.32). NAFLD subgroup analysis showed that early-stage HCC, absence of ascites/hepatic encephalopathy, surveillance, and curative treatment receipt were associated with improved OS. NAFLD patients with coexisting liver disease were more likely to have surveillance, early-stage detection, curative treatment, and improved OS than NAFLD patients without coexisting liver diseases. CONCLUSIONS: NAFLD is the leading etiology of HCC among Medicare beneficiaries. Compared with other etiologies, NAFLD was associated with lower HCC surveillance receipt, early-stage detection, and modestly poorer survival. Multifaceted interventions for improving surveillance uptake are needed to improve prognosis of patients with NAFLD-related HCC.

Racial, Ethnic, and Socioeconomic Disparities in Treatment Delay Among Patients With Hepatocellular Carcinoma in the United States.

BACKGROUND & AIMS: Failures have been reported across the cancer care continuum in patients with hepatocellular carcinoma (HCC); however, the impact of treatment delays on outcomes has not been well-characterized. We described the prevalence of treatment delays in a racially and ethnically diverse cohort of patients and its association with overall survival. METHODS: Using the Surveillance, Epidemiology, and End Results-Medicare database, we identified patients diagnosed with HCC between 2001 and 2015. We performed multivariable logistic regression analysis to identify factors associated with treatment delay (ie, receipt of HCC-directed therapy >3 months after diagnosis). Cox proportional hazards regression analysis with a 5-month landmark was used to characterize the association between treatment delay and overall survival, accounting for immortal time bias. RESULTS: Of 8450 patients with treatment within 12 months of HCC diagnosis, 1205 (14.3%) experienced treatment delays. The proportion with treatment delays ranged from 6.8% of patients undergoing surgical resection to 21.6% of those undergoing liver transplantation. In multivariable analysis, Black patients (odds ratio, 1.96; 95% confidence interval [CI], 1.21-3.15) and those living in high poverty neighborhoods (odds ratio, 1.55; 95% CI, 1.25-1.92) were more likely to experience treatment delays than white patients and those living in low poverty neighborhoods, respectively. Treatment delay was independently associated with worse survival (hazard ratio 1.15, 95% CI, 1.05-1.25). CONCLUSIONS: Nearly 1 in 7 patients with HCC experience treatment delays, with higher odds in Black patients and those living in high poverty neighborhoods. Treatment delays are associated with worse survival, highlighting a need for interventions to improve time-to-treatment.

Real-World Adherence and Effectiveness of Remote Patient Monitoring Among Medicaid Patients With Diabetes: Retrospective Cohort Study.

BACKGROUND: The prevalence of diabetes in the United States is high and increasing, and it is also the most expensive chronic condition in the United States. Self-monitoring of blood glucose or continuous glucose monitoring are potential solutions, but there are barriers to their use. Remote patient monitoring (RPM) with appropriate support has the potential to provide solutions. OBJECTIVE: We aim to investigate the adherence of Medicaid patients with diabetes to daily RPM protocols, the relationship between adherence and changes in blood glucose levels, and the impact of daily testing time on blood glucose changes. METHODS: This retrospective cohort study analyzed real-world data from an RPM company that provides services to Texas Medicaid patients with diabetes. Overall, 180 days of blood glucose data from an RPM company were collected to assess transmission rates and blood glucose changes, after the first 30 days of data were excluded due to startup effects. Patients were separated into adherent and nonadherent cohorts, where adherent patients transmitted data on at least 120 of the 150 days. z tests and t tests were performed to compare transmission rates and blood glucose changes between 2 cohorts. In addition, we analyzed blood glucose changes based on their testing time-between 1 AM and 10 AM, 10 AM and 6 PM, and 6 PM and 1 AM. RESULTS: Mean patient age was 70.5 (SD 11.8) years, with 66.8% (n=255) of them being female, 91.9% (n=351) urban, and 89% (n=340) from south Texas (n=382). The adherent cohort (n=186, 48.7%) had a mean transmission rate of 82.8% before the adherence call and 91.1% after. The nonadherent cohort (n=196, 51.3%) had a mean transmission rate of 45.9% before and 60.2% after. The mean blood glucose levels of the adherent cohort decreased by an average of 9 mg/dL (P=.002) over 5 months. We also found that variability of blood glucose level of the adherent cohort improved 3 mg/dL (P=.03) over the 5-month period. Both cohorts had the majority of their transmissions between 1 AM and 10 AM, with 70.5% and 53.2% for the adherent and nonadherent cohorts, respectively. The adherent cohort had decreasing mean blood glucose levels over 5 months, with the largest decrease during the 6 PM to 1 AM time period (30.9 mg/dL). Variability of blood glucose improved only for those tested from 10 AM to 6 PM, with improvements of 6.9 mg/dL (P=.02). Those in the nonadherent cohort did not report significant changes. CONCLUSIONS: RPM can help manage diabetes in Medicaid clients by improving adherence rates and glycemic control. Adherence calls helped improve adherence rates, but some patients still faced challenges in transmitting blood glucose levels. Nonetheless, RPM has the potential to reduce the risk of adverse outcomes associated with diabetes.

Correction: Adherence to Telemonitoring Therapy for Medicaid Patients With Hypertension: Case Study.

[This corrects the article DOI: 10.2196/29018.].

A Study of Publicly Available Resources Addressing Legal Data-Sharing Barriers: Systematic Assessment.

BACKGROUND: United States data protection laws vary depending on the data type and its context. Data projects involving social determinants of health often concern different data protection laws, making them difficult to navigate. OBJECTIVE: We systematically aggregated and assessed useful online resources to help navigate the data-sharing landscape. METHODS: We included publicly available resources that discussed legal data-sharing issues with some health relevance and published between 2010 and 2019. We conducted an iterative search with a common string pattern using a general-purpose search engine that targeted 24 different sectors identified by Data Across Sectors for Health. We scored each online resource for its depth of legal and data-sharing discussions and value for addressing legal barriers. RESULTS: Out of 3710 total search hits, 2721 unique URLs were reviewed for scope, 322 received full-text review, and 154 were selected for final coding. Legal agreements, consent, and agency guidance were the most widely covered legal topics, with HIPAA (The Health Insurance Portability and Accountability Act), Family Educational Rights and Privacy Act (FERPA), Title 42 of the Code of Federal Regulations Part 2 being the top 3 federal laws discussed. Clinical health care was the most prominent sector with a mention in 73 resources. CONCLUSIONS: This is the first systematic study of publicly available resources on legal data-sharing issues. We found existing gaps where resources covering certain laws or applications may be needed. The volume of resources we found is an indicator that real and perceived legal issues are a substantial barrier to efforts in leveraging data from different sectors to promote health.

Emergency Department Utilization by Adolescents Experiencing Homelessness in Massachusetts.

BACKGROUND: Adolescents who experience homelessness rely heavily on emergency departments (EDs) for their health care. OBJECTIVES: This study estimates the relationship between homelessness and ED use and identifies the sociodemographic, clinical, visit-level, and contextual factors associated with multiple ED visits among adolescents experiencing homelessness in Massachusetts. RESEARCH DESIGN: We used the Healthcare Cost and Utilization Project State Emergency Department Databases on all outpatient ED visits in Massachusetts from 2011 to 2016. We included all adolescents who were 11-21 years old. We estimated the association between homelessness and ED utilization and investigated predictors of multiple ED visits among adolescents who experience homelessness using multivariate logistic and negative binomial regressions. RESULTS: Our study included 1,196,036 adolescents, of whom about 0.8% experienced homelessness and this subset of adolescents accounted for 2.2% of all ED visits. Compared with those with stable housing, adolescents who were homeless were mostly covered through Medicaid (P<0.001), diagnosed with 1 or more comorbidities (P<0.001), and visited the ED at least once for reasons related to mental health; substance and alcohol use; pregnancy; respiratory distress; urinary and sexually transmitted infections; and skin and subcutaneous tissue diseases (P<0.001). Homeless experience was associated with multiple ED visits (incidence rate ratio=1.18; 95% confidence intervals, 1.16-1.19) and frequent ED use (4 or more ED visits) (adjusted odds ratio=2.21; 95% confidence interval, 2.06-2.37). Factors related to clinical complexity and Medicaid compared with lack of coverage were also significant predictors of elevated ED utilization within the cohort experiencing homelessness. CONCLUSIONS: Adolescents who experience homelessness exhibit higher ED use compared with those with stable housing, particularly those with aggravated comorbidities and chronic conditions. Health policy interventions to integrate health care, housing, and social services are essential to transition adolescents experiencing homelessness to more appropriate community-based care.

The effect of expanded insurance coverage under the Affordable Care Act on emergency department utilization in New York.

BACKGROUND: One of the proposed benefits of expanding insurance coverage under the Affordable Care Act (ACA) was a reduction in emergency department (ED) utilization for non-urgent visits related to lack of health insurance coverage and access to primary care providers. The objective of this study was to estimate the effect of the 2014 ACA implementation on ED use in New York. METHODS: We used the Healthcare Cost and Utilization Project State Emergency Department and State Inpatient Databases for all outpatient and all inpatient visits for patients admitted through an ED from 2011 to 2016. We focused on in-state residents aged 18 to 64, who were covered under Medicaid, private insurance, or were uninsured prior to the 2014 expansion. We estimated the effect of the expanded insurance coverage on average monthly ED visits volumes and visits per 1000 residents (rates) using interrupted time-series regression analyses. RESULTS: After ACA implementation, overall average monthly ED visits increased by around 3.0%, both in volume (9362; 95% Confidence Intervals [CI]: 1681-17,522) and in rates (0.80, 95% CI:0.12-1.49). Medicaid covered ED visits volume increased by 23,972 visits (95% CI: 16,240 -31,704) while ED visits by the uninsured declined by 13,297 (95% CI:-15,856 - -10,737), and by 1453 (95% CI:-4027-1121) for the privately insured. Medicaid ED visits rates per 1000 residents increased by 0.77 (95% CI:-1.96-3.51) and by 2.18 (95% CI:-0.55-4.92) for those remaining uninsured, while private insurance visits rates decreased by 0.48 (95% CI:-0.79 - -0.18). We observed increases in primary-care treatable ED visits and in visits related to mental health and alcohol disorders, substance use, diabetes, and hypertension. All estimated changes in monthly ED visits after the expansion were statistically significant, except for ED visit rates among Medicaid beneficiaries. CONCLUSION: Net ED visits by adults 18 to 64 years of age increased in New York after the implementation of the ACA. Large increases in ED use by Medicaid beneficiaries were partially offset by reductions among the uninsured and those with private coverage. Our results suggest that efforts to expand health insurance coverage only will be unlikely to reverse the increase in ED use.

Adherence to Telemonitoring Therapy for Medicaid Patients With Hypertension: Case Study.

BACKGROUND: Almost 50% of the adults in the United States have hypertension. Although clinical trials indicate that home blood pressure monitoring can be effective in managing hypertension, the reported results might not materialize in practice because of patient adherence problems. OBJECTIVE: The aims of this study are to characterize the adherence of Medicaid patients with hypertension to daily telemonitoring, identify the impacts of adherence reminder calls, and investigate associations with blood pressure control. METHODS: This study targeted Medicaid patients with hypertension from the state of Texas. A total of 180 days of blood pressure and pulse data in 2016-2018 from a telemonitoring company were analyzed for mean transmission rate and mean blood pressure change. The first 30 days of data were excluded because of startup effects. The protocols required the patients to transmit readings by a specified time daily. Patients not transmitting their readings received an adherence reminder call to troubleshoot problems and encourage transmission. The patients were classified into adherent and nonadherent cohorts; adherent patients were those who transmitted data on at least 80% of the days. RESULTS: The mean patient age was 73.2 (SD 11.7) years. Of the 823 patients, 536 (65.1%) were women, and 660 (80.2%) were urban residents. The adherent cohort (475/823, 57.7%) had mean transmission rates of 74.9% before the adherence reminder call and 91.3% after the call, whereas the nonadherent cohort (348/823, 42.3%) had mean transmission rates of 39% and 58% before and after the call, respectively. From month 1 to month 5, the transmission rates dropped by 1.9% and 10.2% for the adherent and nonadherent cohorts, respectively. The systolic and diastolic blood pressure values improved by an average of 2.2 and 0.7 mm Hg (P<.001 and P=.004), respectively, for the adherent cohort during the study period, whereas only the systolic blood pressure value improved by an average of 1.6 mm Hg (P=.02) for the nonadherent cohort. CONCLUSIONS: Although we found that patients can achieve high levels of adherence, many experience adherence problems. Although adherence reminder calls help, they may not be sufficient. Telemonitoring lowered blood pressure, as has been observed in clinical trials. Furthermore, blood pressure control was positively associated with adherence.

US Privacy Laws Go Against Public Preferences and Impede Public Health and Research: Survey Study.

BACKGROUND: Reaping the benefits from massive volumes of data collected in all sectors to improve population health, inform personalized medicine, and transform biomedical research requires the delicate balance between the benefits and risks of using individual-level data. There is a patchwork of US data protection laws that vary depending on the type of data, who is using it, and their intended purpose. Differences in these laws challenge big data projects using data from different sources. The decisions to permit or restrict data uses are determined by elected officials; therefore, constituent input is critical to finding the right balance between individual privacy and public benefits. OBJECTIVE: This study explores the US public's preferences for using identifiable data for different purposes without their consent. METHODS: We measured data use preferences of a nationally representative sample of 504 US adults by conducting a web-based survey in February 2020. The survey used a choice-based conjoint analysis. We selected choice-based conjoint attributes and levels based on 5 US data protection laws (Health Insurance Portability and Accountability Act, Family Educational Rights and Privacy Act, Privacy Act of 1974, Federal Trade Commission Act, and the Common Rule). There were 72 different combinations of attribute levels, representing different data use scenarios. Participants were given 12 pairs of data use scenarios and were asked to choose the scenario they were the most comfortable with. We then simulated the population preferences by using the hierarchical Bayes regression model using the ChoiceModelR package in R. RESULTS: Participants strongly preferred data reuse for public health and research than for profit-driven, marketing, or crime-detection activities. Participants also strongly preferred data use by universities or nonprofit organizations over data use by businesses and governments. Participants were fairly indifferent about the different types of data used (health, education, government, or economic data). CONCLUSIONS: Our results show a notable incongruence between public preferences and current US data protection laws. Our findings appear to show that the US public favors data uses promoting social benefits over those promoting individual or organizational interests. This study provides strong support for continued efforts to provide safe access to useful data sets for research and public health. Policy makers should consider more robust public health and research data use exceptions to align laws with public preferences. In addition, policy makers who revise laws to enable data use for research and public health should consider more comprehensive protection mechanisms, including transparent use of data and accountability.

The Effect of the Medicaid Expansion on Frequent Emergency Department Use in New York.

BACKGROUND: There is limited evidence on the effect of the Affordable Care Act (ACA) on frequent emergency department (ED) use. OBJECTIVES: To estimate the effect of the ACA Medicaid expansion on frequent ED use in New York. METHODS: We used data from the Healthcare Cost and Utilization Project State Emergency Department Databases and State Inpatient Databases from 2011 to 2016. A consistent and unique patient identifier enabled us to identify ED visits by the same patient across different facilities within the state for each calendar year. Multivariate logistic regressions were used to quantify the policy's effect on frequent ED use (≥ 4 ED visits/year). We included in-state residents 18 to 64 years of age who were covered by Medicaid, private insurance, or were uninsured. Sensitivity analyses were conducted using alternative definitions of frequent use. To validate the findings, a falsification analysis was also conducted using only the 3 pre-expansion years. RESULTS: Our study included 14.3 million ED patients with 23.8 million ED visits from 2011 to 2016. Frequent users (7.2%) accounted for 26.6% of all ED visits. The likelihood of frequent ED use declined by 4% among Medicaid beneficiaries (adjusted odds ratio [AOR] 0.96, 95% confidence intervals (CI) 0.95-0.97) and by 12% for the uninsured (AOR 0.88, 95% CI 0.86-0.89) in the post-expansion period, compared with the pre-expansion period. Private insurance enrollees were 9% more likely to exhibit frequent use in the post-expansion period (AOR 1.09, 95% CI 1.08-1.11). The sensitivity analyses yielded results similar to those of the main model. The falsification analyses revealed small and insignificant year-to-year changes in the 3 pre-expansion years. CONCLUSION: The likelihood of frequent ED use decreased 3 years after New York implemented the ACA Medicaid expansion, particularly for Medicaid beneficiaries and the uninsured, highlighting the importance of expanding health insurance and provisions tailored at high-need populations.

Predictors of Multiple Emergency Department Utilization Among Frequent Emergency Department Users in 3 States.

BACKGROUND: Research on frequent emergency department (ED) use shows that a subgroup of patients visits multiple EDs. This study characterizes these individuals. OBJECTIVE: The objective of this study was to determine how many frequent ED users seek care at multiple EDs and to identify sociodemographic, clinical, and contextual factors associated with such behavior. RESEARCH DESIGN: We used the 2011-2014 Healthcare Cost and Utilization Project State Emergency Department Databases data on all outpatient ED visits in New York, Massachusetts, and Florida. We studied all adult ED users with ≥5 visits in a year and defined multisite use as visits to ≥3 different sites. We estimated predictors of multisite use with multivariate logistic regressions. RESULTS: Across all 3 states, 1,033,626 frequent users accounted for 7,613,077 ED visits. Of frequent users, 25% were multisite users, accounting for 30% of the visits studied. Frequent users with at least 1 visit for mental health or substance use-related diagnosis were more likely to use multiple sites. Uninsured frequent users and those with public insurance were associated with less use of multiple EDs than those with private coverage while lacking consistent coverage by the same insurance within each year were associated with using multiple sites. CONCLUSIONS: Health policy interventions to reduce duplicative or unnecessary ED use should apply a population health perspective and engage multiple hospitals. Community-level preventive approaches and a stronger infrastructure for mental health and substance use are essential to mitigate multisite ED use.

Communicating With Patients About Software for Enhancing Privacy in Secondary Database Research Involving Record Linkage: Delphi Study.

BACKGROUND: There is substantial prior research on the perspectives of patients on the use of health information for research. Numerous communication barriers challenge transparency between researchers and data participants in secondary database research (eg, waiver of informed consent and knowledge gaps). Individual concerns and misconceptions challenge the trust in researchers among patients despite efforts to protect data. Technical software used to protect research data can further complicate the public's understanding of research. For example, MiNDFIRL (Minimum Necessary Disclosure For Interactive Record Linkage) is a prototype software that can be used to enhance the confidentiality of data sets by restricting disclosures of identifying information during the record linkage process. However, software, such as MiNDFIRL, which is used to protect data, must overcome the aforementioned communication barriers. One proposed solution is the creation of an interactive web-based frequently asked question (FAQ) template that can be adapted and used to communicate research issues to data subjects. OBJECTIVE: This study aims to improve communication with patients and transparency about how complex software, such as MiNDFIRL, is used to enhance privacy in secondary database studies to maintain the public's trust in researchers. METHODS: A Delphi technique with 3 rounds of the survey was used to develop the FAQ document to communicate privacy issues related to a generic secondary database study using the MiNDFIRL software. The Delphi panel consisted of 38 patients with chronic health conditions. We revised the FAQ between Delphi rounds and provided participants with a summary of the feedback. We adopted a conservative consensus threshold of less than 10% negative feedback per FAQ section. RESULTS: We developed a consensus language for 21 of the 24 FAQ sections. Participant feedback demonstrated preference differences (eg, brevity vs comprehensiveness). We adapted the final FAQ into an interactive web-based format that 94% (31/33) of the participants found helpful or very helpful. The template FAQ and MiNDFIRL source code are available on GitHub. The results indicate the following patient communication considerations: patients have diverse and varied preferences; the tone is important but challenging; and patients want information on security, identifiers, and final disposition of information. CONCLUSIONS: The findings of this study provide insights into what research-related information is useful to patients and how researchers can communicate such information. These findings align with the current understanding of health literacy and its challenges. Communication is essential to transparency and ethical data use, yet it is exceedingly challenging. Developing FAQ template language to accompany a complex software may enable researchers to provide greater transparency when informed consent is not possible.

Hepatocellular Carcinoma Screening Is Associated With Increased Survival of Patients With Cirrhosis.

BACKGROUND & AIMS: Hepatocellular carcinoma (HCC) screening of patients with cirrhosis is recommended by professional societies to increase detection of early stage tumors and survival, but is underused in clinical practice. METHODS: We conducted a retrospective cohort study of 13,714 patients diagnosed with HCC from 2003 through 2013 included in the Surveillance, Epidemiology, and End Results Program-Medicare database. We characterized receipt of HCC screening in the 3 years before HCC diagnosis using mutually exclusive categories (consistent vs inconsistent vs no screening) and the proportion of time covered with screening. Correlates for screening receipt were assessed using a multivariable 2-part regression model. We examined the association between screening receipt and early detection of tumors using multivariable logistic regression. We evaluated associations between screening receipt and overall survival using a Cox proportional hazards model, after adjustments for effects of lead-time bias and length-time bias on survival rate estimators. RESULTS: Most patients with cirrhosis (51.1%) did not receive any screening in the 3 years before a diagnosis of HCC, and only 6.8% of patients underwent consistent annual screening. The proportion with consistent screening increased from 5.4% in 2003 to 2006 to 8.8% in 2011 to 2013 (P < .001). The mean proportion of time covered was 13.4% overall, which increased from 11.7% in 2003 to 2006 to 15.2% in 2011 to 2013. Receipt of consistent screening was associated with detection of early stage tumors (odds ratio, 1.98; 95% CI, 1.68-2.33) and a reduced risk of death after correction for lead-time bias (hazard ratio, 0.76; 95% CI, 0.70-0.83). Inconsistent screening was associated with a slightly smaller increase in early detection of HCC (odds ratio, 1.31; 95% CI, 1.20-1.43) and a reduced risk of death (hazard ratio, 0.86; 95% CI, 0.83-0.90). After correction for lead- and length-time biases, higher proportions of patients with consistent (23%; 95% CI, 21%-25%) and inconsistent screening (19%; 95% CI, 19%-20%) survived for 3 years compared with patients without screening (13%; 95% CI, 12%-14%). CONCLUSIONS: In an analysis of the Surveillance, Epidemiology, and End Results Program-Medicare database, we found HCC screening to be underused for patients with cirrhosis. This contributes to detection of liver tumors at later stages and shorter times of survival. However, the proportion of patients screened for HCC has increased over time.

Assessing the Effect of Clinical Inertia on Diabetes Outcomes: a Modeling Approach.

BACKGROUND: There are an increasing number of newer and better therapeutic options in the management of diabetes. However, a large proportion of diabetes patients still experience delays in intensification of treatment to achieve appropriate blood glucose targets-a phenomenon called clinical inertia. Despite the high prevalence of clinical inertia, previous research has not examined its long-term effects on diabetes-related health outcomes and mortality. OBJECTIVE: We sought to examine the impact of clinical inertia on the incidence of diabetes-related complications and death. We also examined how the impact of clinical inertia would vary by the length of treatment delay and population characteristics. DESIGN: We developed an agent-based model of diabetes and its complications. The model was parameterized and validated by data from health surveys, cohort studies, and trials. SUBJECTS: We studied a simulated cohort of patients with diabetes in San Antonio, TX. MAIN MEASURES: We examined 25-year incidences of diabetes-related complications, including retinopathy, neuropathy, nephropathy, and cardiovascular disease. KEY RESULTS: One-year clinical inertia could increase the cumulative incidences of retinopathy, neuropathy, and nephropathy by 7%, 8%, and 18%, respectively. The effects of clinical inertia could be worse for populations who have a longer treatment delay, are aged 65 years or older, or are non-Hispanic whites. CONCLUSION: Clinical inertia could result in a substantial increase in the incidence of diabetes-related complications and mortality. A validated agent-based model can be used to study the long-term effect of clinical inertia and, thus, inform clinicians and policymakers to design effective interventions.

Post-acute care referral in United States of America: a multiregional study of factors associated with referral destination in a cohort of patients with coronary artery bypass graft or valve replacement.

BACKGROUND: The use of post-acute care (PAC) for cardiovascular conditions is highly variable across geographical regions. Although PAC benefits include lower readmission rates, better clinical outcomes, and lower mortality, referral patterns vary widely, raising concerns about substandard care and inflated costs. The objective of this study is to identify factors associated with PAC referral decisions at acute care discharge. METHODS: This study is a retrospective Electronic Health Records (EHR) based review of a cohort of patients with coronary artery bypass graft (CABG) and valve replacement (VR). EHR records were extracted from the Cerner Health-Facts Data warehouse and covered 49 hospitals in the United States of America (U.S.) from January 2010 to December 2015. Multinomial logistic regression was used to identify associations of 29 variables comprising patient characteristics, hospital profiles, and patient conditions at discharge. RESULTS: The cohort had 14,224 patients with mean age 63.5 years, with 10,234 (71.9%) male and 11,946 (84%) Caucasian, with 5827 (40.96%) being discharged to home without additional care (Home), 5226 (36.74%) to home health care (HHC), 1721 (12.10%) to skilled nursing facilities (SNF), 1168 (8.22%) to inpatient rehabilitation facilities (IRF), 164 (1.15%) to long term care hospitals (LTCH), and 118 (0.83%) to other locations. Census division, hospital size, teaching hospital status, gender, age, marital status, length of stay, and Charlson comorbidity index were identified as highly significant variables (p- values < 0.001) that influence the PAC referral decision. Overall model accuracy was 62.6%, and multiclass Area Under the Curve (AUC) values were for Home: 0.72; HHC: 0.72; SNF: 0.58; IRF: 0.53; LTCH: 0.52, and others: 0.46. CONCLUSIONS: Census location of the acute care hospital was highly associated with PAC referral practices, as was hospital capacity, with larger hospitals referring patients to PAC at a greater rate than smaller hospitals. Race and gender were also statistically significant, with Asians, Hispanics, and Native Americans being less likely to be referred to PAC compared to Caucasians, and female patients being more likely to be referred than males. Additional analysis indicated that PAC referral practices are also influenced by the mix of PAC services offered in each region.

Barriers to Remote Health Interventions for Type 2 Diabetes: A Systematic Review and Proposed Classification Scheme.

BACKGROUND: Diabetes self-management involves adherence to healthy daily habits typically involving blood glucose monitoring, medication, exercise, and diet. To support self-management, some providers have begun testing remote interventions for monitoring and assisting patients between clinic visits. Although some studies have shown success, there are barriers to widespread adoption. OBJECTIVE: The objective of our study was to identify and classify barriers to adoption of remote health for management of type 2 diabetes. METHODS: The following 6 electronic databases were searched for articles published from 2010 to 2015: MEDLINE (Ovid), Embase (Ovid), CINAHL, Cochrane Central, Northern Light Life Sciences Conference Abstracts, and Scopus (Elsevier). The search identified studies involving remote technologies for type 2 diabetes self-management. Reviewers worked in teams of 2 to review and extract data from identified papers. Information collected included study characteristics, outcomes, dropout rates, technologies used, and barriers identified. RESULTS: A total of 53 publications on 41 studies met the specified criteria. Lack of data accuracy due to input bias (32%, 13/41), limitations on scalability (24%, 10/41), and technology illiteracy (24%, 10/41) were the most commonly cited barriers. Technology illiteracy was most prominent in low-income populations, whereas limitations on scalability were more prominent in mid-income populations. Barriers identified were applied to a conceptual model of successful remote health, which includes patient engagement, patient technology accessibility, quality of care, system technology cost, and provider productivity. In total, 40.5% (60/148) of identified barrier instances impeded patient engagement, which is manifest in the large dropout rates cited (up to 57%). CONCLUSIONS: The barriers identified represent major challenges in the design of remote health interventions for diabetes. Breakthrough technologies and systems are needed to alleviate the barriers identified so far, particularly those associated with patient engagement. Monitoring devices that provide objective and reliable data streams on medication, exercise, diet, and glucose monitoring will be essential for widespread effectiveness. Additional work is needed to understand root causes of high dropout rates, and new interventions are needed to identify and assist those at the greatest risk of dropout. Finally, future studies must quantify costs and benefits to determine financial sustainability.

Effects of maternity care coordination on pregnancy outcomes: propensity-weighted analyses.

Care coordination services that link pregnant women to health-promoting resources, avoid duplication of effort, and improve communication between families and providers have been endorsed as a strategy for reducing disparities in adverse pregnancy outcomes, however empirical evidence regarding the effects of these services is contradictory and incomplete. This study investigates the effects of maternity care coordination (MCC) on pregnancy outcomes in North Carolina. Birth certificate and Medicaid claims data were analyzed for 7,124 women delivering live infants in North Carolina from October 2008 through September 2010, of whom 2,255 received MCC services. Propensity-weighted analyses were conducted to reduce the influence of selection bias in evaluating program participation. Sensitivity analyses compared these results to conventional ordinary least squares analyses. The unadjusted preterm birth rate was lower among women who received MCC services (7.0 % compared to 8.3 % among controls). Propensity-weighted analyses demonstrated that women receiving services had a 1.8 % point reduction in preterm birth risk; p < 0.05). MCC services were also associated with lower pregnancy weight gain (p = 0.10). No effects of MCC were seen for birthweight. These findings suggest that coordination of care in pregnancy can significantly reduce the risk of preterm delivery among Medicaid-enrolled women. Further research evaluating specific components of care coordination services and their effects on preterm birth risk among racial/ethnic and geographic subgroups of Medicaid enrolled mothers could inform efforts to reduce disparities in pregnancy outcome.