( N Engl J Med . 2023;389:11–21) Postpartum hemorrhage (PPH) remains the leading cause of maternal death worldwide despite published recommendations from the World Health Organization (WHO) on prevention and treatment. There are challenges in implementing the PPH recommendations. Delay in detection as well as delay in treatment of PPH are 2 reasons the maternal death rate is high. One reason for the delay in detection is due to the ongoing use of visual estimation of blood loss, which often inaccurately underestimates the amount of lost blood. More aggressive interventions for PPH may be delayed until earlier approaches have failed in stopping the blood loss. In some cases, no effective treatment is administered at all. Finally, although the WHO has given these recommendations, not all hospitals and/or medical professionals are implementing them. This study sought to understand whether a treatment bundle referred to as E-MOTIVE could improve early detection and treatment of PPH in patients with a vaginal birth.
Military members, veterans, and their families belong to a unique American subculture. Studies have identified the need for mental health professionals to attain military cultural competency to practice more effectively within this subculture. As an 88-year-old counseling and training agency with a record of service to the military/veteran communities, it was appropriate that Council for Relationships commit to providing training in military culture for its therapists and students. From 2017 to 2019, the course highlighted in this paper was part of an approved Institutional Review Board (IRB) study intended to assess the success of graduate-level instructional activities focused on promoting participants’ military and veteran-related cultural competency. This article includes an evaluation of the 2013–14 four-day training on military culture that preceded the course. In both, the unique cultural factors associated with military and veteran service were addressed within the context of evidence-based behavioral health treatment. A survey of the four-day participant training and qualitative interview follow-ups revealed that information about the military and its impact on veterans and families promoted changes in attitudes, knowledge, and clinical practice for both experienced and newly trained clinicians. These findings were replicated in the three-year evaluation results. This assessment provides valuable insight about military culture training for practicing and future mental health clinicians. Since there is very little information available in the literature on successful military culture competency training, sharing these results with the broader military and academic communities will give others information on the important components of effective training programs for clinicians, thus, potentially improving therapeutic services to these populations.
Previous studies have shown that in utero stressors can lead to developmental instability (DI). This DI can possibly predispose to disease susceptibility later in life. A composite of differences in bilateral anatomic trait measurements is termed fluctuating asymmetry (FA) and serves as an indicator of DI. Evidence from our laboratory has pointed to the ulna as abnormally symmetric in persons with chronic low back pain (LBP) but not in persons with acute LBP. It was unclear from the previous study whether the duration and the severity of LBP was a factor in this abnormal asymmetry. To explore these questions we examined the relationship between FA in event-related and non-event-related causes of the LBP, which were further classified according to pain severity. A severity index was developed based on frequency of treatment for LBP. Ulna, lower arm, hand width, hand length, wrist width, and third proximal phalange lengths were measured in 109 patients with LBP and 122 controls in four hospitals and clinics in Southern California. Information on the duration and cause of the LBP was obtained by questionnaire. We postulated that the highest incidence of FA would be found in subjects with chronic LBP stemming from non-event-related causes, which might be due to developmental errors. Furthermore, we suspected that the severity of LBP would be directly related to the size of FA. Our results indicated that persons with LBP of more than 6 months9 duration had significant rightward asymmetry in the ulna (p = .04) and a trend to rightward asymmetry in the composite of six hand and arm traits (p = .056). Results indicated no difference between event-related causes, non-event-related causes, and control FA of the ulna. We also found no significant relationship between the LBP severity index and measures of FA or of directional asymmetry. These findings support the results in the previous study showing elevated rightward directional asymmetry in chronic LBP patients. Although our data do not support a relationship between ulnar asymmetry and cause and severity of LBP, other traits, not yet analyzed, may demonstrate such a relationship.
Stepped-wedge cluster randomised trials (SW-CRT) are increasingly being used in health policy and services research, but unless they are conducted and reported to the highest methodological standards, they are unlikely to be useful to decision-makers. Sample size calculations for these designs require allowance for clustering, time effects and repeated measures.
Clustered randomised controlled trials (CRCTs) are increasingly common in primary care. Outcomes within the same cluster tend to be correlated with one another. In sample size calculations, estimates of the intra-cluster correlation coefficient (ICC) are needed to allow for this nonindependence. In studies with observations over more than one time period, estimates of the inter-period correlation (IPC) and the within-period correlation (WPC) are also needed.This is a retrospective cross-sectional study of all patients aged 18 or over with a diagnosis of type-2 diabetes, from The Health Improvement Network (THIN) database, between 1 October 2007 and 31 March 2010. We report estimates of the ICC, IPC, and WPC for typical outcomes using unadjusted and adjusted generalised linear mixed models with cluster and cluster by period random effects. For binary outcomes we report on the proportions scale, which is the appropriate scale for trial design. Estimated ICCs were compared to those reported from a systematic search of CRCTs undertaken in primary care in the UK in type-2 diabetes.Data from 430 general practices, with a median [IQR] number of diabetics per practice of 241 [150-351], were analysed. The ICC for HbA1c was 0.032 (95 % CI 0.026-0.038). For a two-period (each of 12 months) design, the WPC for HbA1c was 0.035 (95 % CI 0.030-0.040) and the IPC was 0.019 (95 % CI 0.014-0.026). The difference between the WPC and the IPC indicates a decay of correlation over time. Following dichotomisation at 7.5 %, the ICC for HbA1c was 0.026 (95 % CI 0.022-0.030). ICCs for other clinical measurements and clinical outcomes are presented. A systematic search of ICCs used in the design of CRCTs involving type-2 diabetes with HbA1c (undichotomised) as the outcome found that published trials tended to use more conservative ICC values (median 0.047, IQR 0.047-0.050) than those reported here.These estimates of ICCs, IPCs, and WPCs for a variety of outcomes commonly used in diabetes trials can be useful for the design of CRCTs. In studies with observations taken at different time-points, the correlation of observations may decay over time, as reflected in lower values for the IPC than for the ICC. The IPC and WPC estimates are the first reported for UK primary care data.
Abstract Background Diarrheal disease is a significant cause of morbidity and mortality in under-fives in many low- and middle-income countries. Changes in food safety, hygiene practices, and nutrition around the weaning period may reduce the risk of disease and improve infant development. The MaaCiwara study aims to evaluate the effectiveness of a community-based educational intervention designed to improve food safety and hygiene behaviours, as well as child nutrition. This update article describes the statistical analysis plan for the MaaCiwara study in detail. Methods and design The MaaCiwara study is a parallel group, two-arm, superiority cluster randomised controlled trial with baseline measures, involving 120 clusters of rural and urban communities. These clusters are randomised to either receive the community-based behaviour change intervention or to the control group. The study participants will be mother–child pairs, with children aged between 6 and 36 months. Data collection involves a day of observation and interviews with each participating mother–child pair, conducted at baseline, 4 months, and 15 months post-intervention. The primary analysis aims to estimate the effectiveness of the intervention on changes to complementary food safety and preparation behaviours, food and water contamination, and diarrhoea. The primary outcomes will be analysed generalised linear mixed models, at individual level, accounting for clusters and rural/urban status to estimate the difference in outcomes between the intervention and control groups. Secondary outcomes include maternal autonomy, enteric infection, nutrition, child anthropometry, and development scores. In addition, structural equation analysis will be conducted to examine the causal relationships between the different outcomes. Trial registration International Standard Randomised Controlled Trial Number (ISRCTN) register: ISRCTN14390796 . Registered on 13 December 2021.
Prognostic scores could be used to guide management of COPD patients and reduce risk of hospital admission but existing scores do not perform well enough and are not practical for primary care. Using data from the Birmingham primary care COPD cohort we developed and internally validated the new BLISS prognostic score from 23 candidate variables. 1558 patients on COPD registers of 71 GP practices and 331 newly-identified patients from a linked case-finding trial were included and their self-reported and clinical data were combined with routine hospital episode statistics. Primary outcome was the record of at least one respiratory admission within 2 years of cohort entry. The model was developed using backward elimination. Missing data were imputed using chained equations. Discrimination and calibration were assessed. Bootstrapping was used for internal validation. Median (min, max) follow up was 2.9 years (1.8, 3.8). 6 variables were retained in the final model: age, CAT score, respiratory admissions previous 12m, BMI, diabetes, FEV1% predicted. After adjustment for optimism, the model performed well in predicting 2yr respiratory admissions (c statistic=0.75 (95%CI 0.72, 0.79). The BLISS score showed better performance in predicting respiratory admissions than existing published scores. All 6 variables are readily available in primary care records or would be easy to collect, and a simple computer programme could calculate the score. Important next steps are external validation, proposing/evaluating a model of use to guide patient management and exploration of the best ways to implement the score in primary care practice.
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