Comparing State-Level and Facility-Based Review to Assess Quality of Severe Maternal Morbidity Reviews.

OBJECTIVE: To compare results from facility-level and state-level severe maternal morbidity (SMM) reviews in Illinois. DESIGN: We report descriptive characteristics about SMM cases and compare the results of both review processes, including the primary cause, assessment of preventability, and factors that contributed to the severity of the SMM cases. SETTING: All birthing hospitals in Illinois. PARTICIPANTS: A total of 81 SMM cases were reviewed by a facility-level committee and the state-level review committee. SMM was defined as any intensive care or critical care unit admission and/or transfusion of 4 or more units of packed red blood cells from conception to 42 days postpartum. RESULTS: Among the cases reviewed by both committees, hemorrhage was the primary cause of morbidity, with 26 (32.1%) and 38 (46.9%) hemorrhage cases identified by the facility-level and state-level committees, respectively. Both committees identified infection/sepsis (n = 12) and preeclampsia/eclampsia (n = 12) as the next most common causes of SMM. State-level review found more cases potentially preventable (n = 29, 35.8% vs n = 18, 22.2%) and more cases not preventable but improvement in care needed (n = 31, 38.3% vs n = 27, 33.3%). State-level review found more provider and system opportunities to alter the SMM outcome and fewer patient opportunities than facility-level review. CONCLUSION: State-level review found more SMM cases potentially preventable and identified more opportunities to improve care than facility-level review. State-level review has the potential to strengthen facility-level reviews by identifying opportunities to improve the review process and develop recommendations and tools to aid facility-level reviews.

Examining the potential preventability of adverse fetal/neonatal outcomes associated with severe maternal morbidity.

BACKGROUND: Severe maternal morbidity (SMM) occurs in 1-2% of pregnancies. Despite the knowledge that a SMM event can contribute to poor fetal/neonatal outcomes, little is known about the preventability of these adverse outcomes. AIMS: To examine adverse fetal/neonatal outcomes associated with SMM to determine if these outcomes were potentially preventable. MATERIALS AND METHODS: A New Zealand national retrospective cohort study examining cases of SMM with an adverse fetal/neonatal outcome. Maternity and initial neonatal care were explored by multidisciplinary panels utilising a preventability tool to assess whether the fetal/neonatal harm was potentially preventable. Adverse fetal/neonatal outcomes were defined as fetal or early neonatal death, Apgar score <7 at five minutes, admission to neonatal intensive care unit or special care baby unit and neonatal encephalopathy. RESULTS: Of 85 cases reviewed, adverse fetal/neonatal outcome was deemed potentially preventable in 55.3% of cases (n = 47/85). Preventability was related to maternal antenatal/peripartum care (in utero) in 39% (n = 33/85), to initial neonatal care (ex utero) in 36% (n = 29/80), and to both maternal and neonatal care in 20% (16/80) of cases. Main contributors to potential preventability were factors related to healthcare providers, particularly lack of recognition of high risk, delayed or failure to diagnose, and delayed or inappropriate treatment. CONCLUSIONS: Multidisciplinary panels found that over half of adverse fetal/neonatal harm associated with SMM was potentially preventable. The novel approach of examining both maternal and neonatal care identifies opportunities to improve fetal/neonatal outcomes associated with SMM at multiple points on the perinatal continuum of care.

Severe maternal morbidity due to obstetric haemorrhage: Potential preventability.

BACKGROUND: Haemorrhage in pregnancy may be life-threatening to woman and infant. The impact of severe obstetric haemorrhage can be reduced by detecting high-risk women, implementing guidelines and treatment plans, early detection of hypovolaemia and timely appropriate treatment. AIMS: To describe cases of severe maternal morbidity caused by obstetric haemorrhage in New Zealand and investigate the potential preventability of these cases. MATERIALS AND METHODS: A multidisciplinary expert review panel was established to review cases of obstetric haemorrhage admitted to intensive care or high-dependency units over an 18-month span in New Zealand. Cases were critically analysed by a multidisciplinary team of clinicians to determine the potential preventability. RESULTS: One hundred and twenty cases were identified, most commonly due to postpartum haemorrhage with 36% (n = 43) deemed potentially preventable, mainly due to delay or failure of diagnosis (65%, 28/43) and/or failure or delay in treatment (91%, 39/43). Twenty-three per cent of cases (28/120) resulted in peripartum hysterectomy of which one-third were deemed potentially preventable. CONCLUSIONS: Prompt recognition and treatment in accordance with evidence-based guidelines is imperative to decrease the burden of morbidity from obstetric haemorrhage. An emphasis on training clinicians to identify haemorrhage in a timely way may avoid unnecessary obstetric emergencies and can improve maternity and neonatal outcomes.

Examining adverse fetal/neonatal outcomes associated with severe maternal morbidity.

BACKGROUND: While there is a global focus on severe maternal morbidity (SMM), less is known about the impact of SMM on fetal and neonatal outcomes. AIMS: To examine fetal/neonatal outcomes associated with SMM. MATERIALS AND METHODS: A national New Zealand (NZ) retrospective cohort study describing fetal/neonatal outcomes of all women with SMM admitted to a NZ Intensive Care Unit (ICU) or High Dependency Unit (HDU) in 2014. Adverse fetal/neonatal outcomes were defined as one or more of the following: fetal or early neonatal death, hypoxic ischaemic encephalopathy, Apgar score less than seven at five minutes, admission to Neonatal Intensive Care Unit or Special Care Baby Unit. RESULTS: There were 400 women with SMM admitted to NZ ICU/HDU units in 2014, and 395 (98.8%) had complete birth/pregnancy outcome information. Of these, 49.4% (195/395) were associated with an adverse fetal/neonatal outcome. Indigenous Maori women had a 30% higher rate of adverse fetal/neonatal outcome compared to NZ European women (63.7% and 48.9% respectively; relative risk = 1.30, 95% CI 1.04-1.64). Pre-eclampsia was associated with an adverse fetal/neonatal outcome in 67% (81/120). Perinatal-related mortality rate was 53.1 per 1000 total births compared to NZ perinatal mortality of 11.2 per 1000 total births for 2014. CONCLUSION: SMM events are associated with high rates of adverse fetal/neonatal outcomes with a higher burden of adverse events for Maori. Further research is needed to explore opportunities in maternal and neonatal care pathways to improve fetal/neonatal outcomes and address inequities.

Preventability review of severe maternal morbidity.

INTRODUCTION: Severe maternal morbidity (SMM) is rising globally. Assessing SMM is an important quality measure. This study aimed to examine SMM in a national cohort in New Zealand. MATERIAL AND METHODS: This is a national retrospective review of pregnant or postpartum women admitted to an Intensive Care Unit or High Dependency Unit during pregnancy or recent postpartum. Outcomes were rates of SMM and assessment of potential preventability. Preventability was defined as any action on the part of the provider, system or patient that may have contributed to progression to more severe morbidity, and was assessed by a multidisciplinary review team. RESULTS: Severe maternal morbidity was 6.2 per 1000 deliveries (95% confidence interval 5.7-6.8) with higher rates for Pacific, Indian and other Asian racial groups. Major blood loss (39.4%), preeclampsia-associated conditions (23.3%) and severe sepsis (14.1%) were the most common causes of SMM. Potential preventability was highest with sepsis cases (56%) followed by preeclampsia and major blood loss (34.3% and 30.9%). Of these cases, only 36.4% were managed appropriately as determined by multidisciplinary review. Provider factors such as inappropriate diagnosis, delay or failure to recognize high risk were the most common factors associated with potential preventability of SMM. Pacific Island women had over twice the rate of preventable morbidity (relative risk 2.48, 95% confidence interval 1.28-4.79). CONCLUSIONS: Multidisciplinary external anonymized review of SMM showed that over a third of cases were potentially preventable, being due to substandard provider care with increased preventability rates for racial/ethnic minority women. Monitoring country rates of SMM and implementing case reviews to assess potential preventability are appropriate quality improvement measures and external review of anonymized cases may reduce racial profiling to inform unbiased appropriate interventions and resource allocation to help prevent these severe events.

Pre-eclampsia causing severe maternal morbidity - A national retrospective review of preventability and opportunities for improved care.

INTRODUCTION: Pre-eclampsia and related sequelae are a leading cause of severe maternal and neonatal morbidity and mortality. A significant proportion of these poor outcomes may be preventable with improvements along the continuum of maternal and neonatal care. AIMS: The aim of this study was to review cases of pre-eclampsia resulting in severe maternal morbidity, describing the maternal and neonatal outcomes and the potential preventability of severe maternal morbidity (SMM). MATERIALS AND METHODS: This was a retrospective cohort study of cases of SMM associated with severe pre-eclampsia - a subset of a national SMM review study. Inclusion criteria for this subset were women who were pregnant or within 42 days of delivery with severe pre-eclampsia as the main reason for admission to an intensive care unit or high dependency unit in New Zealand between 1 August 2013 and 31 January 2015 inclusive. A multidisciplinary expert panel reviewed cases for preventability using a validated preventability tool. RESULTS: Of the 89 severe morbidities that were reviewed, 10 had eclampsia (11%) and there were four neonatal mortalities (4.3%). Multidisciplinary committees assessed the severe morbidity as potentially preventable in 31% (28) of cases with the majority due to delays in diagnosis and suboptimal treatment. CONCLUSION: We found a high level of preventable morbidity in cases of severe pre-eclampsia with a concerning number of preventable eclampsia. Implementation of evidence-based guidelines reinforced with education would assist clinicians to improve risk recognition, timely diagnosis and treatment and decrease potentially preventable severe morbidity associated with pre-eclampsia.

Physical activity and masculinity in rural men: a qualitative study of men recruited from churches.

The majority of rural US men fail to meet physical activity (PA) guidelines and are at risk for chronic diseases. This study sought to understand rural men's perceptions about PA and PA engagement and the influence of masculinity and social norms. From 2011 to 2014, 12 focus groups were conducted with men prior to a church-based health promotion intervention. Men were recruited from Illinois' rural, southernmost seven counties, where 40% of men report no exercise in the past 30 days. We used inductive content analysis methods to identify PA-related themes, and subsequently used elements of the Health, Illness, Men, and Masculinities framework as a lens to explore subthemes. We identified four themes: (i) knowledge of the positive impact of PA on health, (ii) perceptions of appropriate types of PA for men, (iii) the importance of purposeful PA and (iv) the desire to remain strong and active, particularly during aging. These findings can inform strategies for messaging and interventions to promote PA among rural men. Health promotion efforts should consider the intersections between rurality and masculinity as it relates to rural men's perceptions of PA, include information about purposeful PA and encourage them to engage in PA with a support person.

A global view of severe maternal morbidity: moving beyond maternal mortality.

BACKGROUND: Maternal mortality continues to be of great public health importance, however for each woman who dies as the direct or indirect result of pregnancy, many more women experience life-threatening complications. The global burden of severe maternal morbidity (SMM) is not known, but the World Bank estimates that it is increasing over time. Consistent with rates of maternal mortality, SMM rates are higher in low- and middle-income countries (LMICs) than in high-income countries (HICs). SEVERE MATERNAL MORBIDITY IN HIGH-INCOME COUNTRIES: Since the WHO recommended that HICs with low maternal mortality ratios begin to examine SMM to identify systems failures and intervention priorities, researchers in many HICs have turned their attention to SMM. Where surveillance has been conducted, the most common etiologies of SMM have been major obstetric hemorrhage and hypertensive disorders. Of the countries that have conducted SMM reviews, the most common preventable factors were provider-related, specifically failure to identify "high risk" status, delays in diagnosis, and delays in treatment. SEVERE MATERNAL MORBIDITY IN LOW AND MIDDLE INCOME COUNTRIES: The highest burden of SMM is in Sub-Saharan Africa, where estimates of SMM are as high as 198 per 1000 live births. Hemorrhage and hypertensive disorders are the leading conditions contributing to SMM across all regions. Case reviews are rare, but have revealed patterns of substandard maternal health care and suboptimal use of evidence-based strategies to prevent and treat morbidity. EFFECTS OF SMM ON DELIVERY OUTCOMES AND INFANTS: Severe maternal morbidity not only puts the woman's life at risk, her fetus/neonate may suffer consequences of morbidity and mortality as well. Adverse delivery outcomes occur at a higher frequency among women with SMM. Reducing preventable severe maternal morbidity not only reduces the potential for maternal mortality but also improves the health and well-being of the newborn. CONCLUSION: Increasing global maternal morbidity is a failure to achieve broad public health goals of improved women's and infants' health. It is incumbent upon all countries to implement surveillance initiatives to understand the burden of severe morbidity and to implement review processes for assessing potential preventability.

The Relationship between Body Mass Index in Pregnancy and Adverse Maternal, Perinatal, and Neonatal Outcomes in Rural India and Pakistan.

OBJECTIVE: The objective of this study was to describe the relationship between early pregnancy body mass index (BMI) and maternal, perinatal, and neonatal outcomes in rural India and Pakistan. STUDY DESIGN: In a prospective, population-based pregnancy registry implemented in communities in Thatta, Pakistan and Nagpur and Belagavi, India, we obtained women's BMI prior to 12 weeks' gestation (categorized as underweight, normal, overweight, and obese following World Health Organization criteria). Outcomes were assessed 42 days postpartum. RESULTS: The proportion of women with an adverse maternal outcome increased with increasing maternal BMI. Less than one-third of nonoverweight/nonobese women, 47.2% of overweight women, and 56.0% of obese women experienced an adverse maternal outcome. After controlling for site, maternal age and parity, risks of hypertensive disease/severe preeclampsia/eclampsia, cesarean/assisted delivery, and antibiotic use were higher among women with higher BMIs. Overweight women also had significantly higher risk of perinatal and early neonatal mortality compared with underweight/normal BMI women. Overweight women had a significantly higher perinatal mortality rate. CONCLUSION: High BMI in early pregnancy was associated with increased risk of adverse maternal, perinatal, and neonatal outcomes in rural India and Pakistan. These findings present an opportunity to inform efforts for women to optimize weight prior to conception to improve pregnancy outcomes.

Implementing Statewide Severe Maternal Morbidity Review: The Illinois Experience.

CONTEXT: Severe maternal morbidity (SMM) rates in the United States more than doubled between 1998 and 2010. Advanced maternal age and chronic comorbidities do not completely explain the increase in SMM or how to effectively address it. The Centers for Disease Control and Prevention and American College of Obstetricians and Gynecologists have called for facility-level multidisciplinary review of SMM for potential preventability and have issued implementation guidelines. IMPLEMENTATION: Within Illinois, SMM was identified as any intensive or critical care unit admission and/or 4 or more units of packed red blood cells transfused at any time from conception through 42 days postpartum. All cases meeting this definition were counted during statewide surveillance. Cases were selected for review on the basis of their potential to yield insights into factors contributing to preventable SMM or best practices preventing further morbidity or death. If the SMM review committee deemed a case potentially preventable, it identified specific factors associated with missed opportunities and made actionable recommendations for quality improvement. EVALUATION: Approximately 1100 cases of SMM were identified from July 1, 2016, to June 30, 2017, yielding a rate of 76 SMM cases per 10 000 pregnancies. Reviews were conducted on 142 SMM cases. Most SMM cases occurred during delivery hospitalization and more than half were delivered by cesarean section. Hemorrhage was the primary cause of SMM (>50% of the cases). DISCUSSION: Facility-level SMM review was feasible and acceptable in statewide implementation. States that are planning SMM reviews across obstetric facilities should permit ample time for translation of recommendations to practice. Although continued maternal mortality reviews are valuable, they are not sufficient to address the increasing rates of SMM and maternal death. In-depth multidisciplinary review offers the potential to identify factors associated with SMM and interventions to prevent women from moving along the continuum of severity.

Addressing maternal deaths due to violence: the Illinois experience.

Homicide, suicide, and substance abuse accounted for nearly one fourth of all pregnancy-associated deaths in Illinois from 2002 through 2013. Maternal mortality review in Illinois has been primarily focused on obstetric and medical causes and little is known about the circumstances surrounding deaths due to homicide, suicide, and substance abuse, if they are pregnancy related, and if the deaths are potentially preventable. To address this issue, we implemented a process to form a second statewide maternal mortality review committee for deaths due to violence in late 2014. We convened a stakeholder group to accomplish 3 tasks: (1) identify appropriate committee members; (2) identify potential types and sources of information that would be required for a meaningful review of violent maternal deaths; and (3) revise the Maternal Mortality Review Form. Because homicide, suicide, and substance abuse are closely linked to the social determinants of health, the review committee needed to have a broad membership with expertise in areas not required for obstetric maternal mortality review, including social service and community organizations. Identifying additional sources of information is critical; the state Violent Death Reporting System, case management data, and police and autopsy reports provide contextual information that cannot be found in medical records. The stakeholder group revised the Maternal Mortality Review Form to collect information relevant to violent maternal deaths, including screening history and psychosocial history. The form guides the maternal mortality review committee for deaths due to violence to identify potentially preventable factors relating to the woman, her family, systems of care, the community, the legal system, and the institutional environment. The committee has identified potential opportunities to decrease preventable death requiring cooperation with social service agencies and the criminal justice system in addition to the physical and mental health care systems. Illinois has demonstrated that by engaging appropriate members and expanding the information used, it is possible to conduct meaningful reviews of these deaths and make recommendations to prevent future deaths.

Preventing Maternal Morbidity from Obstetric Hemorrhage: Implications of a Provider Training Initiative.

Objective The objective of this study was to compare severe morbidity due to obstetrical hemorrhage and its potential preventability before and after a mandated provider training initiative on obstetric hemorrhage. Study Design Cases of severe morbidity due to obstetric hemorrhage during 2006 (n = 64 before training initiative) and 2010 (n = 71 after training initiative) were identified by a two-factor scoring system of intensive care unit admission and/or transfusion of ≥ 3 units of blood products and reviewed by an expert panel. Preventable factors were categorized as provider, system, and/or patient related. Results Potential preventability did not differ between 2006 and 2010, p = 0.19. Provider factors remained the most common preventable factor (88.2% in 2006 vs. 97.4% in 2010, p = 0.18), but the distribution in types of preventable factors improved over time for delay or failure in assessment (20.6 vs. 0%, p < 0.01) and delay or inappropriate treatment (76.5 vs. 39.5%, p < 0.01). System factors also differed (32.4 vs. 7.9%, p = 0.015) with a notable decline in factors related to policies and procedures (26.5 vs. 2.6%, p < 0.01) between 2006 and 2010. Conclusion We found significant improvement in provider assessment and treatment of obstetric hemorrhage and a significant reduction in preventable factors related to policies and procedures after the training initiative.

Comparing Two Review Processes for Determination of Preventability of Maternal Mortality in Illinois.

OBJECTIVES: To compare the results of two maternal death review processes conducted from 2002 to 2012 by Illinois regionalized perinatal centers with those conducted by the Illinois Department of Public Health's (IDPH's) statewide multidisciplinary external Maternal Mortality Review Committee (MMRC). METHODS: This is a retrospective record review linking MMRC case assessment forms to the IDPH's Maternal Mortality Review Form database to compare causes of death and potential preventability as determined by both review processes. RESULTS: MMRC records for 76 maternal death reviews were linked to the IDPH maternal mortality review form database. Most deaths reviewed by the statewide MMRC were due to pregnancy-related causes. The statewide MMRC differed from the regional perinatal centers on cause of death in 55.3% (n = 42) of cases and on the disposition of potential preventability in 48.7% (n = 37) of cases. The statewide MMRC judged 69.7% (n = 53) of cases potentially preventable, compared with 40.8% (n = 31) for the regional perinatal centers. The MMRC identified more preventable provider and systems factors for potentially preventable deaths compared with regional perinatal centers which identified more preventable patient factors. CONCLUSIONS FOR PRACTICE: The statewide MMRC found more potential preventability and determined that preventability was associated with provider and systems factors, not patient factors. Observed discrepancies between regional perinatal center and statewide MMRC reviews were likely due to the complexity of cases selected for review, the multidisciplinary external composition of the review team, and the de-identification of cases. Multidisciplinary statewide expert panels should be implemented in addition to local and regionalized reviews.

Assessing preventability of maternal mortality in Illinois: 2002-2012.

OBJECTIVE: We sought to describe the potential preventability of pregnancy-related deaths in Illinois from 2002 through 2012 as determined by perinatal centers following the Illinois maternal death review process. STUDY DESIGN: We conducted a retrospective review of all known maternal deaths in the state from 2002 through 2012 with complete records in the Illinois Department of Public Health's Maternal Mortality Review Form database. The association between causes of death and potential preventability was analyzed for pregnancy-related deaths. RESULTS: There were 610 maternal deaths in Illinois during the study period (31.8 per 100,000 live births). One-third of maternal deaths (n = 210) were directly or indirectly related to pregnancy, 7.0% (n = 43) were possibly related, and 52.6% (n = 321) were unrelated. Vascular causes were the most common cause of pregnancy-related death, followed by cardiac causes and hemorrhage. One-third of deaths directly or indirectly related to pregnancy were deemed potentially preventable. Hemorrhage and deaths due to psychiatric causes were most likely to be considered avoidable, while cancer and vascular-related deaths were generally not considered preventable. CONCLUSION: This analysis of pregnancy-related deaths in Illinois, the first in >60 years, found similar causes of death and potential preventability as pregnancy-related death reviews in other states. Analyzing the causes of pregnancy-related death is a critical and necessary step in improving maternal health outcomes, particularly in decreasing potentially preventable pregnancy-related deaths. Greater attention should be directed toward intervening on the provider, systems, and patient factors contributing to preventable deaths.

Preventability of severe acute maternal morbidity.

OBJECTIVE: We sought to assess potential preventability of severe acute maternal morbidity (SAMM) cases admitted to intensive-care units (ICUs) or high-dependency units (HDUs). STUDY DESIGN: Inclusion criteria were admissions to ICUs or HDUs of women who were pregnant or within 42 days of delivery in 4 District Health Board areas (accounting for a third of annual births in New Zealand) during a 17-month period. Cases were reviewed by external multidisciplinary panels using a validated model for assessing preventability. RESULTS: In all, 98 SAMM cases were assessed; 38 (38.8%) cases were deemed potentially preventable, 36 (36.7%) not preventable but improvement in care was needed, and 24 (24.5%) not preventable. The most frequent preventable factors were clinician related: delay or failure in diagnosis or recognition of high-risk status (51%); and delay or inappropriate treatment (70%). The most common causes of preventable severe morbidity were blood loss and septicemia. CONCLUSION: The majority of SAMM cases were potentially preventable or required improvement in care. Themes around substandard care related to delay in diagnosis and treatment for postpartum hemorrhage and septicemia. These findings can inform clinical educational programs and policies to improve maternal outcomes. This study has now been expanded to a national New Zealand audit of all SAMM cases admitted to an ICU/HDU.

Adverse Delivery and Neonatal Outcomes Among Women with Severe Maternal Morbidity in Illinois, 2018-2019.

Objective: To examine adverse delivery outcomes from 2018 to 2019 severe maternal morbidity (SMM) cases that were reviewed by facility-level review committees in Illinois (n = 666) and describe the burden of adverse delivery outcomes among demographic subgroups, SMM etiology, and whether the SMM event was potentially preventable. Materials and Methods: This is a descriptive analysis of the SMM review cohort. Consistent with expert recommendations to identify SMM for hospital quality review, SMM was defined as any intensive care or critical care unit admission and/or transfusion of four or more units of packed red blood cells from conception to 42 days postpartum. Adverse delivery outcomes were fetal death, low birthweight, preterm birth, neonatal intensive care unit admission, and 5-minute Apgar score <7. Chi square and Fisher's exact tests compared maternal demographic and delivery characteristics between the SMM sample and 2018-2019 deliveries in Illinois. Logistic regression modeled the associations between primary cause of morbidity, maternal race/ethnicity, adverse delivery outcomes, and opportunities to alter the outcome to assess whether the burden of adverse birth outcomes was distributed evenly across subcategories of the cohort. Results: Overall, 53.9% of women with SMM had at least one adverse delivery outcome. SMM events owing to preeclampsia/eclampsia (adjusted odds ratio [aOR] = 4.41, 95% confidence interval [CI] = 2.37-8.24) and infection/sepsis (aOR = 4.40, 95% CI = 1.79-11.04) were more likely to be accompanied by adverse delivery outcomes compared with hemorrhage-related SMM. Non-Hispanic Black women with SMM were more likely to have an adverse delivery outcome compared with non-Hispanic White women with SMM (aOR = 1.74, 95% CI = 1.01-3.02). Conclusion: A greater proportion of the SMM review cohort experienced adverse delivery outcomes compared with the overall birthing population in the state. Non-Hispanic Black women with SMM were almost twice as likely to have an adverse delivery outcome compared with non-Hispanic White women.

Federally Funded Randomized Controlled Trials Increase Analysis and Reporting of Study Outcomes by Sex, Race, and Ethnicity.

Background: We previously examined National Institutes of Health (NIH)-funded randomized controlled trials (RCTs) published in 2004, 2009, and 2015 and found low compliance with NIH policies on inclusion, analysis, and reporting results for female and minoritized subgroups, with no improvement over time. We conducted a fourth wave of data collection using RCTs published in 2021, comparing current results with previous years. Materials and Methods: The authors used PubMed to find 657 RCTs published in print in 14 leading US medical journals in 2021. Of those, 93 (14.2%) were eligible for analysis. We reviewed all parts of eligible studies and any published commentary. Fisher's exact statistics compared proportions of studies analyzing or reporting results for subgroups in 2021 compared with RCTs studied in previous waves. Posthoc analysis compared eligible RCTs about the Covid-19 pandemic to eligible RCTs on other topics. Results: Twenty-five of 93 studies (26.9%) analyzed or reported outcomes by race or ethnicity, an increase over previous years (p < 0.01). Among 79 RCTs with participants of both sexes, the median proportion of female participants was 43%. Moreover, 34 (43.0%) reported an outcome by sex, included sex as a covariate in statistical analysis, or reported results by sex, also an increase over previous waves (p < 0.01). Eleven eligible studies (11.8%) were on a SARS-CoV-2 topic; there was no difference between SARS-CoV-2 RCTs and RCTs on other topics. Conclusions: Analysis and reporting by sex, race, and ethnicity for NIH-funded RCTs published in 2021 significantly increased from previous waves, despite no corresponding increase in enrollment.

Application of the consolidated framework for implementation research to understand implementation context of a cardiovascular disease risk-reduction intervention in rural churches.

Rural populations in the USA face higher rates of cardiovascular disease (CVD) incidence and mortality relative to non-rural and often lack access to health-promoting evidence-based interventions (EBIs) to support CVD prevention and management. Partnerships with faith organizations offer promise for translating preventative EBIs in rural communities; however, studies demonstrating effective translation of EBIs in these settings are limited. We used the Consolidated Framework for Implementation Research (CFIR) and a multiple case study approach to understand the role of internal organizational context within 12 rural churches in the implementation of a 12-week CVD risk-reduction intervention followed by a 24-month maintenance program implemented in southernmost Illinois. The study involved qualitative analysis of key informant interviews collected before (n = 26) and after (n = 15) the intervention and monthly implementation reports (n = 238) from participating churches using a deductive analysis approach based on the CFIR. Internal context across participating churches varied around organizational climate and culture in four thematic areas: (i) religious basis for health promotion, (ii) history of health activities within the church, (iii) perceived need for the intervention, and (iv) church leader engagement. Faith organizations may be ideal partners in rural health promotion research but may vary in their interest and capacity to collaborate. Identifying contextual factors within community organizations is a first step to facilitating rural, community-based EBI implementation and outcomes.

Lifestyle interventions can be effective in lowering heart disease risk, but hard to access for those living in rural areas of the USA for geographic, cultural, and other reasons. Interventions implemented in community settings with partners such as churches are promising for reaching community members and improving health outcomes. Our goal was to identify and understand the role of organizational factors that affected the implementation of an intervention implemented in 12 rural churches to lower heart disease risk by promoting behavior change. By analyzing interview discussions and program documents, we found four factors related to church climate and culture that may have a role in intervention implementation: (i) whether health promotion activities were supported by religious beliefs within the church, (ii) whether churches had a prior history of health activities, (iii) whether church stakeholders expressed a need for the intervention, and (iv) church leader support for the intervention. Attention to these factors may help to improve future implementation of church-based interventions in rural settings.

Perinatal mental health in low-income urban and rural patients: The importance of screening for comorbidities.

OBJECTIVE: To assess the rates and feasibility of assessing comorbid mental health disorders and referral rates in low-income urban and rural perinatal patients. METHODS: In two urban and one rural clinic serving primarily low-income perinatal patients of color, a computerized adaptive diagnostic tool CAT-MH® was implemented to assess major depressive disorder (MDD), general anxiety disorder (GAD), suicidality (SS), substance use disorder (SUD), and post-traumatic stress disorder (PTSD) at the first obstetric visit and/or 8 weeks postpartum. RESULTS: Of a total of 717 screens, 10.7% (n = 77 unique patients) were positive for one or more disorders (6.1% one, 2.5% two, 2.1% three or more). MDD was the most common disorder (9.6%) and was most commonly comorbid with GAD (33% of MDD cases), SUD (23%), or PTSD (23%). For patients with a positive screen, referral to treatment was 35.1% overall, with higher rates in urban (51.6%) versus rural (23.9%) clinics (p = 0.03). CONCLUSION: Mental health comorbidities are common in low-income urban and rural populations, but referral rates are low. Promoting mental health in these populations requires comprehensive screening and treatment approaches for psychiatric comorbidities and dedication to increase the availability of mental health prevention and treatment options.

Assessing preventability for obstetric hemorrhage.

We sought to determine preventability for cases of obstetric hemorrhage, identify preventable factors, and compare differences between levels of hospital. We retrospectively reviewed a 1-year cohort of severe and near-miss obstetric hemorrhage in an urban perinatal network. An expert panel, using a validated preventability model, reviewed all cases. Preventability and distribution of preventability factors were compared between levels of hospital care. Sixty-three severe and near-miss obstetric hemorrhage cases were identified from 11 hospitals; 54% were deemed potentially preventable. Overall preventability was not statistically different by level of hospital, and 88% were provider related. The only treatment-related preventability factors were significantly different between levels of hospital and significantly less common in level III hospitals (p < 0.01). The majority of obstetric hemorrhage was preventable. The most common potentially preventable factor was provider treatment error, and this was significantly more common in level II hospitals. New interventions should be focused on decreasing providers' treatment errors.