PLoS medicine
-
Multicenter Study Observational Study
Consecutive prediction of adverse maternal outcomes of preeclampsia, using the PIERS-ML and fullPIERS models: A multicountry prospective observational study.
Preeclampsia is a potentially life-threatening pregnancy complication. Among women whose pregnancies are complicated by preeclampsia, the Preeclampsia Integrated Estimate of RiSk (PIERS) models (i.e., the PIERS Machine Learning [PIERS-ML] model, and the logistic regression-based fullPIERS model) accurately identify individuals at greatest or least risk of adverse maternal outcomes within 48 h following admission. Both models were developed and validated to be used as part of initial assessment. In the United Kingdom, the National Institute for Health and Care Excellence (NICE) recommends repeated use of such static models for ongoing assessment beyond the first 48 h. This study evaluated the models' performance during such consecutive prediction. ⋯ In this study, we have evaluated the performance of the fullPIERS and PIERS-ML models for consecutive prediction. We observed deteriorating performance of both models over time. We recommend using the models for consecutive prediction with greater caution and interpreting predictions with increasing uncertainty as the pregnancy progresses. For clinical practice, models should be adapted to retain accuracy when deployed serially. The performance of future models can be compared with the results of this study to quantify their added value.
-
Multicenter Study Comparative Study Observational Study
Comparative analysis of 2 approaches to monitor countries' progress towards full and equal access to sexual and reproductive health care, information, and education in 75 countries: An observational validation study.
Sustainable Development Goal (SDG) Indicator 5.6.2 is the "Number of countries with laws and regulations that guarantee full and equal access to women and men aged 15 years and older to sexual and reproductive health care, information, and education." This indicator plays a key role in tracking global progress toward achieving gender equity and empowerment, ensuring its validity is essential. Significant challenges related to the indicator's calculation have been noted, which have important implications for the indicator's validity in measuring progress towards meeting the SDG target. Recommendations have been made to revise the scoring of the indicator. This study examines the indicator's validity by proposing a revision to the indicator's calculation that addresses these global concerns and comparing the resulting values. ⋯ Our results illustrate underlying challenges with the current indicator formulation that impact its interpretability. The proposed changes could alter the way the current legal landscape governing sexual and reproductive health is understood, thereby pointing to different programmatic and policy priorities that may better support countries in achieving full and equal access to sexual and reproductive health and rights globally.
-
Randomized Controlled Trial Multicenter Study
Determining optimal timing of birth for women with chronic or gestational hypertension at term: The WILL (When to Induce Labour to Limit risk in pregnancy hypertension) randomised trial.
Chronic or gestational hypertension complicates approximately 7% of pregnancies, half of which reach 37 weeks' gestation. Early term birth (at 37 to 38 weeks) may reduce maternal complications, cesareans, stillbirths, and costs but may increase neonatal morbidity. In the WILL Trial (When to Induce Labour to Limit risk in pregnancy hypertension), we aimed to establish optimal timing of birth for women with chronic or gestational hypertension who reach term and remain well. ⋯ In this study, we observed that most women with chronic or gestational hypertension required labour induction, and planned birth at 38+0-3 weeks (versus usual care) resulted in birth an average of 6 days earlier, and no differences in poor maternal outcome or neonatal morbidity. Our findings provide reassurance about planned birth at 38+0-3 weeks as a clinical option for these women.
-
Multicenter Study
Identification and outcomes of acute kidney disease in patients presenting in Bolivia, Brazil, South Africa, and Nepal.
The International Society of Nephrology proposes an acute kidney disease (AKD) management strategy that includes a risk score to aid AKD identification in low- and low-middle-income countries (LLMICs). We investigated the performance of the risk score and determined kidney and patient outcomes from AKD at multiple LLMIC sites. ⋯ The use of a risk score can aid AKD identification in LLMICs. High rates of persistent kidney disease and mortality after discharge highlight the importance of AKD follow-up in low-resource settings.
-
Multicenter Study
Safety and tolerability of tegoprubart in patients with amyotrophic lateral sclerosis: A Phase 2A clinical trial.
The interaction of CD40L and its receptor CD40 on activated T cells and B cells respectively control pro-inflammatory activation in the pathophysiology of autoimmunity and transplant rejection. Previous studies have implicated signaling pathways involving CD40L (interchangeably referred to as CD154), as well as adaptive and innate immune cell activation, in the induction of neuroinflammation in neurodegenerative diseases. This study aimed to assess the safety, tolerability, and impact on pro-inflammatory biomarker profiles of an anti CD40L antibody, tegoprubart, in individuals with amyotrophic lateral sclerosis (ALS). ⋯ Tegoprubart appeared to be safe and well tolerated in adults with ALS demonstrating dose-dependent reduction in pro-inflammatory chemokines and cytokines associated with ALS. These results warrant further clinical studies with sufficient power and duration to assess clinical outcomes as a potential treatment for adults with ALS.