Cardiovascular Disease Risk Factor Control Following Release From Carceral Facilities: A Cross-Sectional Study.

BACKGROUND: Incarceration is a social determinant of cardiovascular health but is rarely addressed in clinical settings or public health prevention efforts. People who have been incarcerated are more likely to develop cardiovascular disease (CVD) at younger ages and have worse cardiovascular outcomes compared with the general population, even after controlling for traditional risk factors. This study aims to identify incarceration-specific factors that are associated with uncontrolled CVD risk factors to identify potential targets for prevention. METHODS AND RESULTS: Using data from JUSTICE (Justice-Involved Individuals Cardiovascular Disease Epidemiology), a prospective cohort study of individuals released from incarceration with CVD risk factors, we examine the unique association between incarceration-specific factors and CVD risk factor control. Participants (N=471), with a mean age of 45.0±10.8 (SD) years, were disproportionately from racially minoritized groups (79%), and poor (91%). Over half (54%) had at least 1 uncontrolled CVD risk factor at baseline. People released from jail, compared with prison, had lower Life's Essential 8 scores for blood pressure and smoking. Release from jail, as compared with prison, was associated with an increased odds of having an uncontrolled CVD risk factor, even after adjusting for age, race and ethnicity, gender, perceived stress, and life adversity score (adjusted odds ratio 1.62 [95% CI, 1.02-2.57]). DISCUSSION: Release from jail is associated with poor CVD risk factor control and requires tailored intervention, which is informative as states design and implement the Centers of Medicare & Medicaid Services Reentry 1115 waiver, which allows Medicaid to cover services before release from correctional facilities.

Incarceration and screen-detectable cancer diagnosis among adults in Connecticut.

Although incarcerated adults are at elevated risk of dying from cancer, little is known about cancer screening in carceral settings. This study compared stage-specific incidence of screen-detectable cancers among incarcerated and recently released people with the general population, as a reflection of screening practices. We calculated the age- and sex-standardized incidence ratios (SIR) for early- and late-stage cancers for incarcerated and recently released adults compared to the general Connecticut population between 2005 and 2016. Our sample included 143 cancer cases among those incarcerated, 406 among those recently released, and 201 360 in the general population. The SIR for early-stage screen-detectable cancers was lower among incarcerated (SIR = 0.28, 95% CI = 0.17 to 0.43) and recently released (SIR = 0.69, 95% CI = 0.51 to 0.88) individuals than the general population. Incidence of late-stage screen-detectable cancer was lower during incarceration (SIR = 0.51, 95% CI = 0.27 to 0.88) but not after release (SIR = 1.32, 95% CI = 0.93 to 1.82). Findings suggest that underscreening and underdetection of cancer may occur in carceral settings.

COVID-19 vaccine deliberation in individuals directly impacted by incarceration.

Delays in vaccinating communities of color to COVID-19 have signaled a need to investigate structural barriers to vaccine uptake, with mass incarceration demanding greater characterization as a potential factor. In a nationally representative survey from February-March 2021 (N = 1,157), exposure to the criminal legal system, defined as having been incarcerated in prison or jail or having had a family member or close friend incarcerated, was associated with higher odds for COVID-19 vaccine deliberation. Individuals with criminal legal system exposure reported lower confidence in physician recommendation as a reason to get vaccinated. They were also more likely to decline vaccination out of fear it would cause COVID-19 infection, and that the vaccine might be promoted as a political tool. Our analysis suggests that populations impacted by the criminal legal system would benefit from targeted vaccine outreach by trusted community members who can address distrust during current and future pandemics.

Cancer incidence among incarcerated and formerly incarcerated individuals: A statewide retrospective cohort study.

BACKGROUND: Cancer incidence among individuals with incarceration exposure has been rarely studied due to the absence of linked datasets. This study examined cancer incidence during incarceration and postincarceration compared to the general population using a statewide linked cohort. METHODS: We constructed a retrospective cohort from a linkage of state tumor registry and correctional system data for Connecticut residents from 2005 to 2016, and identified cancers diagnosed during and within 12 months postincarceration. We estimated incidence rates (including for screen-detectable cancers) and calculated the standardized incidence ratios (SIR) for the incarcerated and recently released populations, relative to the general population. We also examined cancer incidence by race and ethnicity within each group. RESULTS: Cancer incidence was lower in incarcerated individuals (SIR = 0.64, 95% CI 0.56-0.72), but higher in recently released individuals (SIR = 1.34, 95% CI 1.23-1.47) compared with the general population, and across all race and ethnic strata. Similarly, nonscreen-detectable cancer incidence was lower in incarcerated and higher in recently released populations compared to the general population. However, non-Hispanic Black individuals had elevated incidence of screen-detectable cancers compared with non-Hispanic White individuals across all three populations (incarcerated, SIR = 1.66, 95% CI 1.03-2.53; recently released, SIR = 1.83, 95% CI 1.32-2.47; and general population, SIR = 1.18, 95% CI 1.16-1.21). CONCLUSION: Compared with the general population, incarcerated persons have a lower cancer incidence, whereas recently released persons have a higher cancer incidence. Irrespective of incarceration status, non-Hispanic Black individuals have a higher incidence of screen-detectable cancers compared with non-Hispanic White individuals. Supplemental studies examining cancer screening and diagnoses during incarceration are needed to discern the reasons for observed disparities in incidence.

Characteristics of recently incarcerated primary care patients with and without a positive posttraumatic stress disorder screening upon clinic intake.

OBJECTIVE: Posttraumatic stress disorder (PTSD) is prevalent among people who have been incarcerated. Here, we examined whether screening positive for PTSD was associated with other indicators of poor health, acute healthcare utilization, and poverty among primary care patients upon release from incarceration. METHOD: We conducted a cross-sectional survey in a national network of primary care clinics serving people recently released from incarceration. Participants were 416 patients who completed the Primary Care PTSD screen (PC-PTSD) and other questions about mental and physical health, acute healthcare utilization, and economic status within 6 months of release. RESULTS: Screening positive for PTSD was associated with worse status across nearly all variables examined, including being more likely to report: poor/fair health (61.6% vs. 41.7%), current depressive symptoms (89.7% vs. 50.8%), lifetime depression diagnosis (63.3% vs. 35.3%), cannabis use since release (20.7% vs. 9.6%), homelessness (31.9% vs. 18.5%), having no cash on hand (56.3% vs. 39.0%) and severe food insecurity (29.3% vs. 18.2%; all ps < .01). Reporting recent suicidality (14.3% vs. 7.0%), alcohol use since release (30.2% vs. 20.0%), and emergency department utilization (20.4% vs. 12.2%) was also more likely (all ps ≤ .03). These trends were largely upheld when controlling for demographic characteristics and chronic physical health conditions using linear probability regression. CONCLUSIONS: Primary care patients recently released from incarceration have a need for wrap-around services that address health challenges and poverty. Patients with significant PTSD symptoms face even greater challenges. Identification and treatment of PTSD both during and after incarceration is warranted. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Exploring the Relationship between Debt and Health after Incarceration: a Survey Study.

Financial debt and incarceration are both independently associated with poor health, but there is limited research on the association between debt and health for those leaving incarceration. This exploratory study surveyed 75 people with a chronic health condition and recent incarceration to examine debt burden, financial well-being, and possible associations with self-reported health. Eighty-four percent of participants owed at least one debt, with non-legal debt being more common than legal debt. High financial stress was associated with poor self-reported health and the number of debts owed. Owing specific forms of debt was associated with poor health or high financial stress. Non-legal financial debt is common after incarceration, and related stress is associated with poor self-reported health. Future research is needed in larger populations in different geographical areas to further investigate the relationship and the impact debt may have on post-release poor health outcomes. Policy initiatives to address debt in the post-release population may improve health.

Incarceration status and cancer mortality: A population-based study.

BACKGROUND: The complex relationship between incarceration and cancer survival has not been thoroughly evaluated. We assessed whether cancer diagnosis during incarceration or the immediate post-release period is associated with higher rates of mortality compared with those never incarcerated. METHODS: We conducted a population-based study using a statewide linkage of tumor registry and correctional system movement data for Connecticut adult residents diagnosed with invasive cancer from 2005 through 2016. The independent variable was place of cancer diagnosis: during incarceration, within 12 months post-release, and never incarcerated. The dependent variables were five-year cancer-related and overall survival rates. RESULTS: Of the 216,540 adults diagnosed with invasive cancer during the study period, 239 (0.11%) people were diagnosed during incarceration, 479 (0.22%) within 12 months following release, and the remaining were never incarcerated. After accounting for demographics and cancer characteristics, including stage of diagnosis, the risk for cancer-related death at five years was significantly higher among those diagnosed while incarcerated (AHR = 1.39, 95% CI = 1.12-1.73) and those recently released (AHR = 1.82, 95% CI = 1.57-2.10) compared to the never-incarcerated group. The risk for all-cause mortality was also higher for those diagnosed with cancer while incarcerated (AHR = 1.92, 95% CI = 1.63-2.26) and those recently released (AHR = 2.18, 95% CI = 1.94-2.45). CONCLUSIONS AND RELEVANCE: There is a higher risk of cancer mortality among individuals diagnosed with cancer during incarceration and in the first-year post-release, which is not fully explained by stage of diagnosis. Cancer prevention and treatment efforts should target people who experience incarceration and identify why incarceration is associated with worse outcomes.

Cost savings of a primary care program for individuals recently released from prison: a propensity-matched study.

BACKGROUND: Criminal justice system costs in the United States have exponentially increased over the last decades, and providing health care to individuals released from incarceration is costly. To better understand how to manage costs to state budgets for those who have been incarcerated, we aimed to assess state-level costs of an enhanced primary care program, Transitions Clinic Network (TCN), for chronically-ill and older individuals recently released from prison. METHODS: We linked administrative data from Connecticut Department of Correction, Medicaid, and Department of Mental Health and Addiction Services to identify a propensity matched comparison group and estimate costs of a primary care program serving chronically-ill and older individuals released from incarceration between 2013 and 2016. We matched 94 people released from incarceration who received care at a TCN program to 94 people released from incarceration who did not receive care at TCN program on numerous characteristics. People eligible for TCN program participation were released from incarceration within the prior 6 months and had a chronic health condition or were over the age of 50. We estimated 1) costs associated with the TCN program and 2) costs accrued by Medicaid and the criminal justice system. We evaluated associations between program participation and Medicaid and criminal justice system costs over a 12-month period using bivariate analyses with nonparametric bootstrapping method. RESULTS: The 12-month TCN program operating cost was estimated at $54,394 ($146 per participant per month). Average monthly Medicaid costs per participant were not statistically different between the TCN ($1737 ± $3449) and comparison ($1356 ± $2530) groups. Average monthly criminal justice system costs per participant were significantly lower among TCN group ($733 ± $1130) compared with the matched group ($1276 ± $1738, p < 0.05). We estimate every dollar invested in the TCN program yielded a 12-month return of $2.55 to the state. CONCLUSIONS: Medicaid investments in an enhanced primary care program for individuals returning from incarceration are cost neutral and positively impact state budgets by reducing criminal justice system costs.

Comparative Effectiveness of Digital Breast Tomosynthesis and Mammography in Older Women.

BACKGROUND: Digital breast tomosynthesis (DBT) has become a prevalent mode of breast cancer screening in recent years. Although older women are commonly screened for breast cancer, little is known about screening outcomes using DBT among older women. OBJECTIVE: To assess proximal screening outcomes with DBT compared to traditional two-dimensional(2-D) mammography among women 67-74 and women 75 and older. DESIGN: Cohort study. PARTICIPANTS: Medicare fee-for-service beneficiaries aged 67 years and older with no history of prior cancer who received a screening mammogram in 2015. MAIN MEASURES: Use of subsequent imaging (ultrasound and diagnostic mammography) as an indication of recall, breast cancer detection, and characteristics of breast cancer at the time of diagnosis. Analyses used weighted logistic regression to adjust for potential confounders. KEY RESULTS: Our study included 26,406 women aged 67-74 and 17,001 women 75 and older who were screened for breast cancer. Among women 75 and older, the rate of subsequent imaging among women screened with DBT did not differ significantly from 2-D mammography (91.8 versus 97.0 per 1,000 screening mammograms, p=0.37). In this age group, DBT was associated with 2.1 additional cancers detected per 1,000 screening mammograms compared to 2D (11.5 versus 9.4, p=0.003), though these additional cancers were almost exclusively in situ and stage I invasive cancers. For women 67-74 years old, DBT was associated with a higher rate of subsequent imaging than 2-D mammography (113.9 versus 100.3, p=0.004) and a higher rate of stage I invasive cancer detection (4.7 versus 3.7, p=0.002), but not other stages. CONCLUSIONS: Breast cancer screening with DBT was not associated with lower rates of subsequent imaging among older women. Most additional cancers detected with DBT were early stage. Whether detecting these additional early-stage cancers among older women improves health outcomes remains uncertain.

Formerly Incarcerated Community Health Workers Engaging Individuals Returning From Incarceration Into Primary Care: Results From the Transition Clinic Network.

Over half a million individuals return from United States prisons and millions more from jails every year, many of whom with complex health and social needs. Community health workers (CHWs) perform diverse roles to improve health outcomes in disadvantaged communities, but no studies have assessed their role as integrated members of a primary care team serving individuals returning from incarceration. Using data from participants who received primary care through the Transitions Clinic Network, a model of care that integrates CHWs with a lived experienced of incarceration into primary care teams, we characterized how CHWs address participant health and social needs during interactions outside of clinic visits for 6 months after participants established primary care. Among the 751 participants, 79% had one or more CHW interactions outside of the clinic documented. Participants with more comorbid conditions, longer stays during their most recent incarceration, and released with a prescription had more interactions with CHWs compared to those with fewer comorbidities, shorter stays, and no prescription at release. Median number of interactions was 4 (interquartile range, IQR 2-8) and 56% were in person. The most common issues addressed (34%) were social determinants of health, with the most common being housing (35%). CHWs working in interdisciplinary primary care teams caring for people with histories of incarceration perform a variety of functions for clients outside of scheduled primary care visits. To improve health outcomes among disadvantaged populations, CHWs should be able to work across multiple systems, with supervision and support for CHW activities both in the primary care clinic and within the community.

Comparative Effectiveness of Digital Breast Tomosynthesis for Breast Cancer Screening Among Women 40-64 Years Old.

BACKGROUND: Digital breast tomosynthesis (DBT) may have a higher cancer detection rate and lower recall compared with 2-dimensional (2 D) mammography for breast cancer screening. The goal of this study was to evaluate screening outcomes with DBT in a real-world cohort and to characterize the population health impact of DBT as it is widely adopted. METHODS: This observational study evaluated breast cancer screening outcomes among women screened with 2 D mammography vs DBT. We used deidentified administrative data from a large private health insurer and included women aged 40-64 years screened between January 2015 and December 2017. Outcomes included recall, biopsy, and incident cancers detected. We used 2 complementary techniques: a patient-level analysis using multivariable logistic regression and an area-level analysis evaluating the relationship between population-level adoption of DBT use and outcomes. All statistical tests were 2-sided. RESULTS: Our sample included 7 602 869 mammograms in 4 580 698 women, 27.5% of whom received DBT. DBT was associated with modestly lower recall compared with 2 D mammography (113.6 recalls per 1000 screens, 99% confidence interval [CI] = 113.0 to 114.2 vs 115.4, 99% CI = 115.0 to 115.8, P < .001), although younger women aged 40-44 years had a larger reduction in recall (153 recalls per 1000 screens, 99% CI = 151 to 155 vs 164 recalls per 1000 screens, 99% CI = 163 to 166, P < .001). DBT was associated with higher biopsy rates than 2 D mammography (19.6 biopsies per 1000 screens, 99% CI = 19.3 to 19.8 vs 15.2, 99% CI = 15.1 to 15.4, P < .001) and a higher cancer detection rate (4.9 incident cancers per 1000 screens, 99% CI = 4.7 to 5.0 vs 3.8, 99% CI = 3.7 to 3.9, P < .001). Point estimates from the area-level analysis generally supported these findings. CONCLUSIONS: In a large population of privately insured women, DBT was associated with a slightly lower recall rate than 2 D mammography and a higher cancer detection rate. Whether this increased cancer detection improves clinical outcomes remains unknown.

Breast cancer supplemental screening: Women's knowledge and utilization in the era of dense breast legislation.

BACKGROUND: Given the growth in dense breast notification (DBN) legislation in the United States, we examined the association between different types of DBN laws and supplemental screening behaviors among women. METHODS: We surveyed in March-April 2018 a nationally representative sample of women aged 40-59 years who received a routine screening mammogram in the past 18 months. Survey items included the following topics regarding supplemental screening: discussing risks or benefits with a provider, knowledge about the risk of false positives, and utilization. We grouped women by state DBN into non-DBN, generic DBN (mentions breast density but not supplemental screening), DBN that mentions supplemental screening (DBN-SS), and DBN with mandated insurance coverage for supplemental screening (DBN-coverage), and estimated adjusted predicted probabilities for supplemental screening behaviors. RESULTS: Of 1641 women surveyed, 21.3% resided in non-DBN, 41.2% in generic DBN, 25.8% in DBN-SS, and 12.5% in DBN-coverage states. Overall, 23.0% of respondents had discussed supplemental screening with a provider, 11.3% of whom discussed the risks, and 49.5% discussed the benefits. In adjusted analysis, women living in DBN-coverage states were more likely to discuss supplemental screening (27.5%) than women in non-DBN states (13.6%); pairwise contrast 13.8% (95% CI, 2.1% to 25.6%; P = .01). They were also more likely to have received supplemental screening for increased breast density (19.3%) compared to women living in non-DBN (9.9%); contrast 9.4% (95% CI, 1.6% to 17.3%; P = .01), Generic DBN (7.3%); difference 12.0% (95% CI, 4.6% to 19.4%; P =< .001), and DBN-SS (8.8%); contrast 10.5% (95% CI, 2.6% to 18.5%; P < .01) states. CONCLUSIONS: Women in DBN-coverage states were more likely to discuss supplemental screening with their providers, and to undergo supplemental screening, compared to women in states with other types of DBN laws, or without DBN laws.

Dense Breast Notification Laws, Education, and Women's Awareness and Knowledge of Breast Density: a Nationally Representative Survey.

BACKGROUND: To date, 38 states have enacted dense breast notification (DBN) laws mandating that mammogram reports include language informing women of risks related to dense breast tissue. OBJECTIVE: Nationally representative survey to assess the association between residing in a state with a DBN law and women's awareness and knowledge about breast density, and breast cancer anxiety. DESIGN: Internet survey conducted in 2018 with participants in KnowledgePanel®, an online research panel. PARTICIPANTS: English-speaking US women ages 40-59 years without a personal history of breast cancer who had received at least one screening mammogram (N = 1928; survey completion rate 68.2%). MAIN MEASURES: (1) Reported history of increased breast density, (2) knowledge of the increased risk of breast cancer with dense breasts, (3) knowledge of the masking effect of dense breasts on mammography, and (4) breast cancer anxiety. KEY RESULTS: Women residing in DBN states were more likely to report increased breast density (43.6%) compared with women residing in non-DBN states (32.7%, p < 0.01, adjusted odds ratio, 1.70, 95% CI,1.34-2.17). Interaction effect between DBN states and education status showed that the impact of DBN on women's reporting of dense breasts was significant for women with greater than high school education, but not among women with a high school education or less (p value = 0.01 for interaction). Only 23.0% of women overall knew that increased breast density was associated with a higher risk of breast cancer, and 68.0% of women understood that dense breasts decreased the sensitivity of mammography. There were no significant differences between women in DBN states and non-DBN states for these outcomes, or for breast cancer-related anxiety. CONCLUSIONS: State DBN laws were not associated with increased understanding of the clinical implications of breast density. DBN laws were associated with a higher likelihood of women reporting increased breast density, though not among women with lower education.

Perceived Discrimination Based on Criminal Record in Healthcare Settings and Self-Reported Health Status among Formerly Incarcerated Individuals.

Perceived discrimination based on criminal record is associated with social determinants of health such as housing and employment. However, there is limited data on discrimination based on criminal record within health care settings. We examined how perceived discrimination based on criminal record within health care settings, among individuals with a history of incarceration, was associated with self-reported general health status. We used data from individuals recruited from 11 sites within the Transitions Clinic Network (TCN) who were released from prison within the prior 6 months, had a chronic health condition and/or were age 50 or older, and had complete information on demographics, medical history, self-reported general health status, and self-reported perceived discrimination (n = 743).Study participants were mostly of minority racial and ethnic background (76%), and had a high prevalence of self-reported chronic health conditions with half reporting mental health conditions and substance use disorders (52% and 50%, respectively), and 85% reporting one or more chronic medical conditions. Over a quarter (27%, n = 203) reported perceived discrimination by health care providers due to criminal record with a higher proportion of individuals with fair or poor health reporting discrimination compared to those in good or excellent health (33% vs. 23%; p = .002). After adjusting for age and reported chronic conditions, participants reporting discrimination due to criminal record had 43% increased odds of reporting fair/poor health (AOR 1.43, 95% CI 1.01-2.03). Race and ethnicity did not modify this relationship.Participants reporting discrimination due to criminal record had increased odds of reporting fair/poor health. The association between perceived discrimination by health care providers due to criminal record and health should be explored in future longitudinal studies among individuals at high risk of incarceration.Clinical Trial Registration: NCT01863290.

Propensity-matched study of enhanced primary care on contact with the criminal justice system among individuals recently released from prison to New Haven.

BACKGROUND: Health systems can be integral to addressing population health, including persons with incarceration exposure. Few studies have comprehensively integrated state-wide data to assess how the primary care system can impact criminal justice outcomes. We examined whether enhanced primary care can decrease future contact with the criminal justice system among individuals just released from prison. METHODS: We linked administrative data (2013-2016) of Connecticut Department of Correction, Department of Mental Health and Addiction Services, Department of Social Service, Court Support Services Division, and Department of Public Health to conduct a quasi-experimental study using propensity score matching of 94 participants who received enhanced primary care in Transitions Clinic to 94 controls not exposed to the programme. The propensity score included 23 variables, which encompassed participants' medical and incarceration history and service utilisation. The main outcomes were reincarceration rates and days incarcerated in the first year from the index date, which was either enrolment in the Transitions Clinic programme or release from prison in the control group. RESULTS: The odds of reincarceration, including arrests and new convictions, were similar for the two groups, but Transitions Clinic participants had lower odds of returning to prison for a parole or probation technical violation (adjusted OR: 0.38; 95% CI 0.16 to 0.93) compared with the control group. Further, Transitions Clinic participants had fewer incarceration days (incidence rate ratio: 0.55; 95% CI 0.35 to 0.84) compared with the control group. CONCLUSIONS: Enhanced primary care for individuals just released from prison can reduce reincarceration for technical violations and shorten time spent within correctional facilities. This study shows how community health systems may play a role in current strategies to reduce prison populations.

Association of State Dense Breast Notification Laws With Supplemental Testing and Cancer Detection After Screening Mammography.

OBJECTIVES: To evaluate the association of state dense breast notification (DBN) laws with use of supplemental tests and cancer diagnosis after screening mammography. METHODS: We examined screening mammograms (n = 1 441 544) performed in 2014 and 2015 among privately insured women aged 40 to 59 years living in 9 US states that enacted DBN laws in 2014 to 2015 and 25 US states with no DBN law in effect. DBN status at screening mammography was categorized as no DBN, generic DBN, and DBN that mandates notification of possible benefits of supplemental screening (DBN+SS). We used logistic regression to examine the change in rate of supplemental ultrasound, magnetic resonance imaging, breast biopsy, and breast cancer detection. RESULTS: DBN+SS laws were associated with 10.5 more ultrasounds per 1000 mammograms (95% CI = 3.0, 17.6 per 1000; P = .006) and 0.37 more breast cancers detected per 1000 mammograms (95% CI = 0.05, 0.69 per 1000; P = .02) compared with no DBN law. No significant differences were found for generic DBN laws in either ultrasound or cancer detection. CONCLUSIONS: DBN legislation is associated with increased use of ultrasound and cancer detection after implementation only when notification of the possible benefits of supplemental screening is required.

The Share Project: Building Capacity of Justice-Involved Individuals, Policymakers, and Researchers to Collectively Transform Health Care Delivery.

The Share Project (TSP), a US health justice initiative, convened key stakeholders to advance the use of inclusive research methods and data sharing to engage groups that are typically marginalized from research. TSP trained justice-involved patients, community health workers, policymakers, and researchers in participatory research and the use of a data-sharing platform developed with justice-involved patients. The platform allowed users to analyze health and criminal justice data to develop new research that is patient driven and responsive to the needs of providers.

Adherence to the International Committee of Medical Journal Editors' (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals.

BACKGROUND: Registration of clinical trials is critical for promoting transparency and integrity in medical research; however, trials must be registered in a prospective fashion to deter unaccounted protocol modifications or selection of alternate outcomes that may enhance favorability of reported findings. We assessed adherence to the International Committee of Medical Journal Editors' (ICMJE) prospective registration policy and identified the frequency of registrations occurring after potential observation of primary outcome data among trials published in the highest-impact journals associated with US professional medical societies. Additionally, we examined whether trials that are unregistered or registered after potential observation of primary outcome data were more likely to report favorable findings. METHODS: We conducted a retrospective, cross-sectional analysis of the 50 most recently published clinical trials that reported primary results in each of the ten highest-impact US medical specialty society journals between 1 January 2010 and 31 December 2015. We used descriptive statistics to characterize the proportions of trials that were: registered; registered retrospectively; registered retrospectively potentially after initial ascertainment of primary outcomes; and reporting favorable findings, overall and stratified by journal and trial characteristics. Chi-squared analyses were performed to assess differences in registration by journal and trial characteristics. RESULTS: We reviewed 6869 original research reports published between 1 January 2010 and 31 December 2015 to identify a total of 486 trials across 472 publications. Of these 486 trials, 47 (10%) were unregistered. Among 439 registered trials, 340 (77%) were registered prospectively and 99 (23%) retrospectively. Sixty-seven (68%) of these 99 retrospectively registered trials, or 15% of all 439 registered trials, were registered after potential observation of primary outcome data ascertained among participants enrolled at inception. Industry-funded trials, those with enrollment sites in the US, as well as those assessing FDA-regulated interventions each had lower rates of retrospective registration. Unregistered trials were more likely to report favorable findings than were registered trials (89% vs. 64%; relative risk (RR) = 1.38, 95% confidence interval (CI) = 1.20-1.58; p = 0.004), irrespective of registration timing. CONCLUSIONS: Adherence to the ICMJE's prospective registration policy remains sub-standard, even in the highest-impact journals associated with US professional medical societies. These journals frequently published unregistered trials and trials registered after potential observation of primary outcome data.

Health Literacy Among a Formerly Incarcerated Population Using Data from the Transitions Clinic Network.

Health literacy is increasingly understood to be a mediator of chronic disease self-management and health care utilization. However, there has been very little research examining health literacy among incarcerated persons. This study aimed to describe the health literacy and relevant patient characteristics in a recently incarcerated primary care patient population in 12 communities in 6 states and Puerto Rico. Baseline data were collected from 751 individuals through the national Transitions Clinic Network (TCN), a model which utilizes a community health worker (CHW) with a previous history of incarceration to engage previously incarcerated people with chronic medical diseases in medical care upon release. Participants in this study completed study measures during or shortly after their first medical visit in the TCN. Data included demographics, health-related survey responses, and a measure of health literacy, The Newest Vital Sign (NVS). Bivariate and linear regression models were fit to explore associations among health literacy and the time from release to first clinic appointment, number of emergency room visits before first clinic appointment and confidence in adhering to medication. Our study found that almost 60% of the sample had inadequate health literacy. Inadequate health literacy was associated with decreased confidence in taking medications following release and an increased likelihood of visiting the emergency department prior to primary care. Early engagement may improve health risks for this population of individuals that is at high risk of death, acute care utilization, and hospitalization following release.