Prevalence and risk factors for milk allergy overdiagnosis in the BEEP trial cohort.

Background: Cow's milk allergy (CMA) overdiagnosis in young children appears to be increasing and has not been well characterised. We used a clinical trial population to characterise CMA overdiagnosis and identify individual-level and primary care practice-level risk factors.

Methods: We analysed data from 1394 children born in England in 2014-2016 (BEEP trial, ISRCTN21528841).

A mixed-methods study to investigate feasibility and acceptability of an early warning score for preterm infants in neonatal units in Kenya: results of the NEWS-K study : Neonatal early warning scores in Kenya.

 Preterm birth (< 37 weeks gestation) complications are the leading cause of neonatal mortality. Early-warning scores (EWS) are charts where vital signs (e.g.

Emollients for preventing atopic eczema: Cost-effectiveness analysis of the BEEP trial.

Background: Recent discoveries have led to the suggestion that enhancing skin barrier from birth might prevent eczema and food allergy.

Objective: To determine the cost-effectiveness of daily all-over-body application of emollient during the first year of life for preventing atopic eczema in high-risk children at 2 years from a health service perspective. We also considered a 5-year time horizon as a sensitivity analysis.

Feasibility of a RCT of techniques for managing an impacted fetal head during emergency caesarean section: the MIDAS scoping study.

Background: Second-stage caesarean sections, of which there are around 34,000 per year in the UK, have greater maternal and perinatal morbidity than those in the first stage. The fetal head is often deeply impacted in the maternal pelvis, and extraction can be difficult. Numerous techniques are reported, but the superiority of one over another is contentious and there is no national guidance.

Emollients for prevention of atopic dermatitis: 5-year findings from the BEEP randomized trial.

Background: The effectiveness of emollients for preventing atopic dermatitis/eczema is controversial. The Barrier Enhancement for Eczema Prevention trial evaluated the effects of daily emollients during the first year of life on atopic dermatitis and atopic conditions to age 5 years.

Methods: 1394 term infants with a family history of atopic disease were randomized (1:1) to daily emollient plus standard skin-care advice (693 emollient group) or standard skin-care advice alone (701 controls).

COVID-19 during pregnancy and its impact on the developing auditory system.

Background: This study compared distortion product otoacoustic emissions (DPOAEs) and click-evoked auditory brainstem responses (ABRs) recorded from infants whose mother had Covid-19 during pregnancy (Covid-19 group) to infants whose mother did not have Covid-19 (Control group) during pregnancy.

Methods: This study retrospectively examined records of infants in the Covid-19 group (n = 15) and control group (n = 46) who had distortion product otoacoustic emissions (DPOAEs) and click-evoked auditory brainstem responses (ABRs) recorded as part of their clinical assessment. DPOAE amplitudes, absolute latencies (I, III, and V), and I-V interpeak intervals were examined.

Clinical examination for hyperlinear palms to determine filaggrin genotype: A diagnostic test accuracy study.

Background: Palmar hyperlinearity is a feature of ichthyosis vulgaris, the monogenic skin disorder caused by FLG loss-of-function mutations.

Objective: To investigate how well the presence or absence of hyperlinear palms (HLP) detect FLG genotype in children.

Methods: STARD criteria are used to report this diagnostic accuracy study.

Promoting Independence in Dementia (PRIDE): A Feasibility Randomized Controlled Trial.

Background: There is a need for interventions to foster and maintain independence for people with dementia to support community living, improve morale, and reduce stigma. We investigated a social intervention to promote living well and enhance independence for people with mild dementia.

Methods: In this two arm parallel group, feasibility RCT at six sites in England, participants were randomized (1:1) to the PRIDE intervention (encompassing social, physical, and cognitive domains supported by a facilitator over three sessions) compared to usual care only.

Feasibility of using an Early Warning Score for preterm or low birthweight infants in a low-resource setting: results of a mixed-methods study at a national referral hospital in Kenya.

Introduction: Fifteen million babies are born prematurely, before 37 weeks gestational age, globally. More than 80% of these are in sub-Saharan Africa and Asia. 35% of all deaths in the first month of life are due to prematurity and the neonatal mortality rate is eight times higher in low-income and middle-income countries (LMICs) than in Europe.

Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial.

Background: Failure to collect outcome data in randomised trials can result in bias and loss of statistical power. Further evaluations of strategies to increase retention are required. We assessed the effectiveness of two strategies for retention in a randomised prevention trial using a two-by-two factorial randomised study within a trial (SWAT).

Standard care informed by the result of a placental growth factor blood test versus standard care alone in women with reduced fetal movement at or after 36 weeks' gestation: a pilot randomised controlled trial.

Background: Biomarkers of placental function can potentially aid the diagnosis and prediction of pregnancy complications. This randomised controlled pilot trial assessed whether for women with reduced fetal movement (RFM), intervention directed by the measurement of a placental biomarker in addition to standard care was feasible and improved pregnancy outcome compared with standard care alone.

Methods: Women aged 16-50 years presenting at eight UK maternity units with RFM between 36 and 41 weeks' gestation with a viable singleton pregnancy and no indication for immediate delivery were eligible.

Verification of placental growth factor and soluble-fms-like tyrosine kinase 1 assay performance in late pregnancy and their diagnostic test accuracy in women with reduced fetal movement.

Background: Placental growth factor (PlGF) and soluble-fms-like tyrosine kinase 1 (sFlt-1) are biomarkers of placental function used to aid the diagnosis and prediction of pregnancy complications. This work verified the analytical performance of both biomarkers and provides preliminary diagnostic accuracy data to identify adverse pregnancy outcome in women with reduced fetal movement.

Methods: Verification of sFlt-1 and PlGF assays included a comparative accuracy assessment of 24 serum samples analysed at six different sites and laboratory-specific precision estimates.

An algorithm for diagnosing IgE-mediated food allergy in study participants who do not undergo food challenge.

Background: Food allergy diagnosis in clinical studies can be challenging. Oral food challenges (OFC) are time-consuming, carry some risk and may, therefore, not be acceptable to all study participants.

Objective: To design and evaluate an algorithm for detecting IgE-mediated food allergy in clinical study participants who do not undergo OFC.

Group cognitive rehabilitation to reduce the psychological impact of multiple sclerosis on quality of life: the CRAMMS RCT.

Background: People with multiple sclerosis have problems with memory and attention. The effectiveness of cognitive rehabilitation has not been established.

Objectives: The objectives were to assess the clinical effectiveness and cost-effectiveness of a cognitive rehabilitation programme for people with multiple sclerosis.

Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial.

Background: Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone.

Cognitive rehabilitation for attention and memory in people with multiple sclerosis: a randomized controlled trial (CRAMMS).

Objective: To assess the clinical and cost-effectiveness of cognitive rehabilitation for attention and memory problems in people with multiple sclerosis.

Design: Multicentre, pragmatic, randomized controlled trial.

Setting: Community.

Randomised trial of cord clamping at very preterm birth: outcomes at 2 years.

Objective: To report outcomes at 2 years corrected age for children of women recruited to a trial comparing alternative policies for timing of cord clamping and immediate neonatal care at very preterm birth.

Design: Parallel group randomised (1:1) trial.

Setting: Eight UK tertiary maternity units.

A group memory rehabilitation programme for people with traumatic brain injuries: the ReMemBrIn RCT.

Background: People with traumatic brain injuries (TBIs) commonly report memory impairments. These are persistent, debilitating and reduce quality of life, but patients do not routinely receive memory rehabilitation after discharge from hospital.

Objective: To assess the clinical effectiveness and cost-effectiveness of a group memory rehabilitation programme for people with TBI.

Women's experiences of participating in a randomised trial comparing alternative policies for timing of cord clamping at very preterm birth: a questionnaire study.

Background: The Cord Pilot Trial compared two alternative policies for cord-clamping at very preterm birth at eight UK tertiary maternity units: clamping after at least 2 min and immediate neonatal care with cord intact, or clamping within 20 s and neonatal care after clamping. This paper reports views and experiences of the women who participated in the trial (261 randomised), based on data from two self-completed questionnaires.

Methods: Women were given or posted the first questionnaire between 4 and 8 weeks after birth, and posted a second similar questionnaire at 1 year.

Clinical and cost effectiveness of memory rehabilitation following traumatic brain injury: a pragmatic cluster randomized controlled trial.

Objective: To evaluate the clinical and cost effectiveness of a group-based memory rehabilitation programme for people with traumatic brain injury.

Design: Multicentre, pragmatic, observer-blinded, randomized controlled trial in England.

Setting: Community.

Cord pilot trial, comparing alternative policies for timing of cord clamping before 32 weeks gestation: follow-up for women up to one year.

Background: The Cord Pilot Trial compared two alternative policies for cord clamping at very preterm birth at eight UK maternity units: clamping after at least 2 min and immediate neonatal care (if needed) with cord intact, or clamping within 20 s and neonatal care after clamping. This paper reports follow-up of the women by two self-completed questionnaires up to one year after the birth.

Methods: Women were given or posted the first questionnaire between four and eight weeks after birth, usually before their baby was discharged, and were posted a second similar questionnaire at one year.

Temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations: FAST.

Background: Asthma exacerbations affect the quality of life of patients with asthma and have a major effect on the overall costs of asthma care. An asthma self-management plan that advises the temporary quadrupling of inhaled corticosteroid dose may prevent asthma exacerbations, but this needs to be confirmed before being adopted widely.

Objectives: To compare the clinical effectiveness and cost-effectiveness of an asthma self-management plan that advises patients to temporarily quadruple the dose of inhaled corticosteroid when asthma control starts to deteriorate with a standard self-management plan.

Development of a standardised set of metrics for monitoring site performance in multicentre randomised trials: a Delphi study.

Background: Site performance is key to the success of large multicentre randomised trials. A standardised set of clear and accessible summaries of site performance could facilitate the timely identification and resolution of potential problems, minimising their impact. The aim of this study was to identify and agree a core set of key performance metrics for managing multicentre randomised trials.