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AbstractBackgroundIn persons with type 1 diabetes and high glycated hemoglobin levels, the benefits of intermittently scanned continuous glucose monitoring with optional alarms for high and low blood glucose levels are uncertain.MethodsIn a parallel-group, multicenter, randomized, controlled trial involving participants with type 1 diabetes and glycated hemoglobin levels between 7.5% and 11.0%, we investigated the efficacy of intermittently scanned continuous glucose monitoring as compared with participant monitoring of blood glucose levels with fingerstick testing. The primary outcome was the glycated hemoglobin level at 24 weeks, analyzed according to the intention-to-treat principle. Key secondary outcomes included sensor data, participant-reported outcome measures, and safety.ResultsA total of 156 participants were randomly assigned, in a 1:1 ratio, to undergo intermittently scanned continuous glucose monitoring (the intervention group, 78 participants) or to monitor their own blood glucose levels with fingerstick testing (the usual-care group, 78 participants). At baseline, the mean (±SD) age of the participants was 44±15 years, and the mean duration of diabetes was 21±13 years; 44% of the participants were women. The mean baseline glycated hemoglobin level was 8.7±0.9% in the intervention group and 8.5±0.8% in the usual-care group; these levels decreased to 7.9±0.8% and 8.3±0.9%, respectively, at 24 weeks (adjusted mean between-group difference, −0.5 percentage points; 95% confidence interval [CI], −0.7 to −0.3; P<0.001). The time per day that the glucose level was in the target range was 9.0 percentage points (95% CI, 4.7 to 13.3) higher or 130 minutes (95% CI, 68 to 192) longer in the intervention group than in the usual-care group, and the time spent in a hypoglycemic state (blood glucose level, <70 mg per deciliter [<3.9 mmol per liter]) was 3.0 percentage points (95% CI, 1.4 to 4.5) lower or 43 minutes (95% CI, 20 to 65) shorter in the intervention group. Two participants in the usual-care group had an episode of severe hypoglycemia, and 1 participant in the intervention group had a skin reaction to the sensor.ConclusionsAmong participants with type 1 diabetes and high glycated hemoglobin levels, the use of intermittently scanned continuous glucose monitoring with optional alarms for high and low blood glucose levels resulted in significantly lower glycated hemoglobin levels than levels monitored by fingerstick testing. (Funded by Diabetes UK and others; FLASH-UK ClinicalTrials.gov number, NCT03815006.)

We would like to draw attention to evidence of substantial bias in the article published in this journal by Jack et al. (BMC Med 18:1-12, 2020). They provide an analysis of antidepressant prescribing to children and young people (CYP; ages 5 to 17) in primary care in England and reported that only 24.7% of CYP prescribed SSRIs for the first time were seen by a child and adolescent psychiatrist—contrary to national guidelines. We believe that their analysis is based on incomplete data that misses a large proportion of specialist mental health contacts. This is because the dataset Jack et al. used to capture specialist mental health contact—The Hospital Episode Statistics (HES) dataset—has poor coverage, as most CYP mental health services do not submit data. We demonstrate the level of underreporting with an analysis of events in a large primary care dataset where there has been a record of definite contact with CYP mental health services. We report that as many as three quarters of specialist CYP contacts with mental health specialists are missed in the HES dataset, indicating that the figure presented by Jack et al. is substantially wrong.

BackgroundOne-year mortality following acute myocardial infarction (AMI) has declined over time, yet the reasons for this improvement remain unclear. Understanding the drivers of these changes is essential for informing clinical strategies and health policy.MethodsWe analysed 852 914 adult patients admitted with AMI across England and Wales between 2005 and 2019 using national registry data. We examined changes in 1-year all-cause mortality and quantified the contribution of clinical, treatment and demographic factors to this trend using decomposition analysis.ResultsBetween 2005 and 2019, 1-year all-cause mortality declined from 22.8% (95% CI 22.4% to 23.2%) to 14.2% (95% CI 13.7% to 14.7%), an absolute reduction of 8.6 percentage points. Approximately 68.2% of this decline was explained by measured factors. The greatest contributor was increased use of evidence-based pharmacological therapies—including statins, beta blockers and ACE inhibitors—accounting for 27.7% of the reduction (95% CI 26.0% to 29.5%). Increased use of percutaneous coronary intervention (PCI) contributed 17.6% (95% CI 16.3% to 19.0%). Mortality improvements were observed in both ST-elevation myocardial infarction (STEMI) and non-STEMI populations. However, older adults and women continued to experience higher mortality rates throughout the study period.ConclusionOne-year survival after AMI improved substantially over 15 years in England and Wales largely due to advances in pharmacotherapy and PCI. Nevertheless, about one-third of the mortality decline remains unexplained, underscoring the need to investigate other contributors such as postdischarge care and health system factors.

The monarchE study added the CDK4/6 inhibitor abemaciclib to the care of women with oestrogen-positive (ER+) breast cancers. Eligibility required meeting monarchE criteria—either >3 positive axillary nodes, or 1–3 positive sentinel nodes (SNB+) with tumour size >50 mm or grade 3 cancers. Women were advised to proceed to completion axillary node clearance (cANC) if size/grade criteria were not fulfilled for >3 positive nodes to be identified. However, cANC is associated with significant morbidity, conflicting with the potential benefits of abemaciclib. We analysed data of 229 consecutive women (2016-2022) with ER+ breast cancer and SNB+ who proceeded to cANC, keeping with contemporary treatment guidelines. We used this cohort to assess numbers that, under national guidance in place currently, would be advised to undergo cANC solely to check eligibility for abemaciclib treatment. Using monarchE criteria, 90 women (39%) would have accessed abemaciclib based on SNB+ and size/grade, without cANC. In total, 139 women would have been advised to proceed to cANC to check eligibility, with only 15/139 (11%) having >3 positive nodes after sentinel node biopsy and cANC. The remaining 124 (89%) would have undergone cANC but remained ineligible for abemaciclib. Size, age, grade, and Ki67 did not predict >3 nodes at cANC. Following cANC, a large majority of women with ER+, <50 mm, and grade 1–2 tumours remain ineligible for abemaciclib yet are subject to significant morbidity including lifelong lymphoedema risk. The monarchE authors state that 15 women need abemaciclib therapy for 1 to clinically benefit. Thus, in our cohort, 139 women undergoing cANC would lead to one woman benefitting.

To address if the long-standing association between maternal infection, depression/anxiety in pregnancy, and offspring neurodevelopmental disorder (NDD) is causal, we conducted two negative-control studies. Four primary care cohorts of UK children (pregnancy, 1 and 2 years prior to pregnancy, and siblings) born between 1 January 1990 and 31 December 2017 were constructed. NDD included autism/autism spectrum disorder, attention-deficit/hyperactivity disorder, intellectual disability, cerebral palsy, and epilepsy. Maternal exposures included depression/anxiety and/or infection. Maternal (age, smoking status, comorbidities, body mass index, NDD); child (gender, ethnicity, birth year); and area-level (region and level of deprivation) confounders were captured. The NDD incidence rate among (1) children exposed during or outside of pregnancy and (2) siblings discordant for exposure in pregnancy was compared using Cox-regression models, unadjusted and adjusted for confounders. The analysis included 410 461 children of 297 426 mothers and 2 793 018 person-years of follow-up with 8900 NDD cases (incidence rate = 3.2/1000 person years). After adjustments, depression and anxiety consistently associated with NDD (pregnancy-adjusted HR = 1.58, 95% CI 1.46-1.72; 1-year adj. HR = 1.49, 95% CI 1.39-1.60; 2-year adj. HR = 1.62, 95% CI 1.50-1.74); and to a lesser extent, of infection (pregnancy adj. HR = 1.16, 95% CI 1.10-1.22; 1-year adj. HR = 1.20, 95% CI 1.14-1.27; 2-year adj. HR = 1.19, 95% CI 1.12-1.25). NDD risk did not differ among siblings discordant for pregnancy exposure to mental illness HR = 0.97, 95% CI 0.77-1.21 or infection HR = 0.99, 95% CI 0.90-1.08. Maternal risk appears to be unspecific to pregnancy: our study provided no evidence of a specific, and therefore causal, link between in-utero exposure to infection, common mental illness, and later development of NDD.

This study assessed a) the impact of playing the Dignity board game on participants’ understanding of respectful maternal and newborn care and b) participants’ perceptions of how the game influenced their subsequent practice in Malawi and Zambia. Nurse-midwives’ poor understanding of respectful maternal and newborn care can lead to substandard practice; thus, effective education is pivotal. Used in several disciplines, game-based learning can facilitate skills acquisition and retention of knowledge. a quasi-experimental study, using mixed-methods of data collection. Data were collected between January and November 2020. Nurse-midwives (N = 122) and students (N = 115) were recruited from public hospitals and nursing schools. Completion of paper-based questionnaires, before and after game-playing, assessed knowledge of respectful care principles and perceptions around behaviours and practice. Face-to-face interviews (n = 18) explored perceived impact of engaging with the game in clinical practice. Paired and unpaired t-test were used to compare scores. Qualitative data were analysed and reported thematically. The study was completed by 215 (90.7 %) participants. Post-test scores improved significantly for both groups combined; from 25.91 (SD 3.73) pre-test to 28.07 (SD 3.46) post-test (paired t = 8.67, 95 % confidence interval 1.67–2.65), indicating an increased knowledge of respectful care principles. Nurse-midwives performed better than students, both before and after. In Malawi, the COVID pandemic prevented a third of nurse-midwives’ from completing post-game questionnaires. Qualitative findings indicate the game functioned as a refresher course and helped nurse-midwives to translate principles of respectful care into practice. It was also useful for self-reflection. The Dignity board game has the potential to enhance understanding and practice of respectful maternal and newborn care principles in low-resource settings. Integration into nursing and midwifery curricula and in-service training for students and healthcare workers should be considered.

A Correction to this paper has been published: https://doi.org/10.1038/s41416-021-01378-x

Clinical trials assessing systemic sclerosis (SSc)-related digital ulcers have been hampered by a lack of reliable outcome measures of healing. Our objective was to assess the feasibility of patients collecting high-quality mobile phone images of their digital lesions as a first step in developing a smartphone-based outcome measure. Patients with SSc-related digital (finger) lesions photographed one or more lesions each day for 30 days using their smartphone and uploaded the images to a secure Dropbox folder. Image quality was assessed using six criteria: blurriness, shadow, uniformity of lighting, dot location, dot angle and central positioning of the lesion. Patients completed a feedback questionnaire. Twelve patients returned 332 photographs of 18 lesions. Each patient sent a median of 29.5 photographs [interquartile range (IQR) 15-33.5], with a median of 15 photographs per lesion (IQR 6-32). Twenty-two photographs were duplicates. Of the remaining 310 images, 256 (77%) were sufficiently in focus; 268 (81%) had some shadow; lighting was even in 56 (17%); dot location was acceptable in 233 (70%); dot angle was ideal in 107 (32%); and the lesion was centred in 255 (77%). Patient feedback suggested that 6 of 10 would be willing to record images daily in future studies, and 9 of 10 at least one to three times per week. Taking smartphone photographs of digital lesions was feasible for most patients, with most lesions in focus and central in the image. These promising results will inform the next research phase (to develop a smartphone monitoring application incorporating photographs and symptom tracking).