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.

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.

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.

Nutrition and Exercise Strategies to Prevent Excessive Pregnancy Weight Gain: A Meta-analysis.

Objective To evaluate nutrition-only, exercise-only, and nutrition-plus-exercise interventions for optimizing gestational weight gain (GWG) based on the 2009 Institute of Medicine (IOM) guidelines. Study PubMed, Google Scholar, and 2015 Cochrane Review were searched. Analysis of variance was used to determine if significant GWG differences exist between strategies, with additional subanalyses on overweight (OV) or obese women based on 2009 IOM guidelines. Results Of 66 identified studies, 31 contributed data ( n = 8,558). Compared with routine prenatal care, nutrition-only interventions were significantly associated with reduced GWG and are most likely to produce weight gain within IOM recommendations ( p = 0.013). Exercise-only ( p = 0.069) and nutrition-plus-exercise ( p = 0.056) interventions trended toward GWG within IOM guidelines, but did not reach statistical significance. Supervised ( p = 0.61) and unsupervised ( p = 0.494) exercise programs had similar effectiveness. Subanalyses on OV or obese women produced similar results to studies that did not differentiate results based on body mass index: nutrition only ( p = 0.011), exercise only ( p = 0.308), and nutrition plus exercise ( p = 0.129). Conclusion Preventing excessive GWG is crucial, especially for OV or obese women. In the current study, nutrition-based intervention is the health system strategy that showed significant impact on preventing excessive GWG compared with routine prenatal care. Among women who are OV or have obesity, nutrition-only interventions hold the most promise compared with routine prenatal care.