- Meta-analysis and systematic reviews
- Infant Nutrition and Health
- Infant Development and Preterm Care
- Neonatal Respiratory Health Research
- Statistical Methods in Clinical Trials
- Maternal and Perinatal Health Interventions
- Statistical Methods and Bayesian Inference
- Health Systems, Economic Evaluations, Quality of Life
- Birth, Development, and Health
- Reproductive Health and Contraception
- Folate and B Vitamins Research
- Maternal and fetal healthcare
- Tuberculosis Research and Epidemiology
- Pelvic floor disorders treatments
- Neonatal and Maternal Infections
- Statistical Methods and Inference
- Advanced Statistical Methods and Models
- Mycobacterium research and diagnosis
- Adolescent and Pediatric Healthcare
- Delphi Technique in Research
- Complementary and Alternative Medicine Studies
- Health Policy Implementation Science
- Child and Adolescent Psychosocial and Emotional Development
- Surgical site infection prevention
- Reliability and Agreement in Measurement
University of Nottingham
2019-2024
Norfolk and Norwich University Hospitals NHS Foundation Trust
2023
University of Oxford
2017-2021
University of Birmingham
2015-2019
<h2>Summary</h2><h3>Background</h3> Infections acquired in hospital are an important cause of morbidity and mortality very preterm infants. Several small trials have suggested that supplementing the enteral diet infants with lactoferrin, antimicrobial protein processed from cow's milk, prevents infections associated complications. The aim this large randomised controlled trial was to collect data enhance validity applicability evidence previous inform practice. <h3>Methods</h3> In...
A random effects meta‐analysis combines the results of several independent studies to summarise evidence about a particular measure interest, such as treatment effect. The approach allows for unexplained between‐study heterogeneity in true effect by incorporating study overall mean. variance mean estimate is conventionally calculated assuming that between known; however, it has been demonstrated this may be inappropriate, especially when there are few studies. Alternative methods aim account...
Observational data have shown that slow advancement of enteral feeding volumes in preterm infants is associated with a reduced risk necrotizing enterocolitis but an increased late-onset sepsis. However, from randomized trials are limited.We randomly assigned very or very-low-birth-weight to daily milk increments 30 ml per kilogram body weight (faster increment) 18 (slower until reaching full volumes. The primary outcome was survival without moderate severe neurodevelopmental disability at 24...
BackgroundRisk factors for maternal infection are clearly recognised, including caesarean section and operative vaginal birth. Antibiotic prophylaxis at is widely recommended because there clear systematic review evidence that it reduces incidence of infection. Current WHO guidelines do not recommend routine antibiotic women undergoing birth insufficient effectiveness. We aimed to investigate whether prevented after birth.MethodsIn a blinded, randomised controlled trial done 27 UK obstetric...
Infections acquired in hospital are an important cause of morbidity and mortality very preterm infants. Several small trials have suggested that supplementing the enteral diet infants with lactoferrin, antimicrobial protein processed from cow's milk, prevents infections associated complications. To determine whether or not supplementation bovine lactoferrin (The Tatua Cooperative Dairy Company Ltd, Morrinsville, New Zealand) reduces risk late-onset infection (acquired > 72 hours after birth)...
Background Interferon gamma release assays (IGRAs) are blood tests recommended for the diagnosis of tuberculosis (TB) infection. There is currently uncertainty about role and clinical utility IGRAs in diagnostic workup suspected active TB routine NHS practice. Objectives To compare accuracy cost-effectiveness T-SPOT. ® (Oxford Immunotec, Abingdon, UK) QuantiFERON GOLD In-Tube (Cellestis, Carnegie, VIC, Australia) to estimate second-generation IGRAs. Design Prospective within-patient...
Blinding is an established approach in clinical trials which aims to minimise the risk of performance and detection bias. There little empirical evidence guide UK units (CTUs) about practice blinding statisticians. Guidelines recommend that statisticians remain blinded allocation prior final analysis. As these guidelines are not based on evidence, this study undertook a qualitative investigation relating when how should be trials.Data were collected through online focus groups with various...
Patient-reported outcome measures (PROMs) are commonly used in eczema clinical trials. Several trials have PROMs weekly for symptom monitoring. However, the increased frequency of patient-reported monitoring may prompt participants to enhance self-management and increase standard topical treatment use that can lead improvements outcomes over time. This is concerning as constitute an unplanned intervention, which mask small effects make it difficult identify changes resulting from under...
The objective of this study was to examine methodological and reporting characteristics systematic reviews meta-analyses which compare diagnostic test accuracy (DTA) multiple index tests, identify good practice, develop guidance for better reporting.
Abstract Background A nested case-control study is an efficient design that can be embedded within existing cohort or randomised trial. It has a number of advantages compared to the conventional design, and potential answer important research questions using untapped prospectively collected data. Methods We demonstrate utility matched by applying it secondary analysis Abnormal Doppler Enteral Prescription Trial. investigated role milk feed type changes in development necrotising...
Objective Catheter-related sepsis (CRS) is a major complication with significant morbidity and mortality. Evidence lacking regarding the most appropriate antiseptic for skin disinfection before percutaneous central venous catheter (PCVC) insertion in preterm neonates. To inform feasibility design of definitive randomised controlled trial (RCT) two formulations, we conducted Antiseptic Randomised Controlled Trial Insertion Catheters (ARCTIC) study to assess colonisation, sepsis, morbidity....
Background Observational data suggest that slowly advancing enteral feeds in preterm infants may reduce necrotising enterocolitis but increase late-onset sepsis. The Speed of Increasing milk Feeds Trial (SIFT) compared two rates feed advancement. Objective To determine if faster (30 ml/kg/day) or slower (18 daily increments improve survival without moderate severe disability and other morbidities very low-birthweight infants. Design This was a multicentre, two-arm, parallel-group, randomised...
Abstract Background In the UK, approximately 8% of live births are preterm (before 37 weeks gestation), more than 90% whom born between 30 and 36 weeks, forming largest proportion a neonatal units’ workload. Neonatologists cautious in initiating full milk feeds for infants due to fears necrotising enterocolitis (NEC). There is now evidence dispute this fear. Small studies have shown that feeding enterally from birth could result shorter length hospital stay, which important parents,...
In a random effects meta-analysis model, true treatment for each study are routinely assumed to follow normal distribution. However, normality is restrictive assumption and the misspecification of distribution may result in misleading estimate overall mean effect, an inappropriate quantification heterogeneity across studies wrongly symmetric prediction interval. We focus on problems caused by distribution, propose novel model where Box-Cox transformation applied observed effect estimates....
Emotional disorders (such as anxiety and depression) are associated with considerable distress impairment in day-to-day function for affected children young people their families. Effective evidence-based interventions available but require appropriate identification of difficulties to enable timely access services. Standardised diagnostic assessment (SDA) tools may aid the detection emotional disorders, there is limited evidence on utility SDA routine care equipoise among professionals...
Sepsis is one of the most important causes maternal death and severe morbidity worldwide. Studies conducted both in UK US have documented an additional risk associated with operative vaginal delivery. However, a Cochrane review, updated 2017, identified only small trial prophylactic antibiotics following delivery, which included total 393 women. Given size that trial, it recommended further robust evidence needed. Operative delivery rates vary worldwide, but typically 5–10% women births. A...
Background Sepsis is a leading cause of direct and indirect maternal death in both the UK globally. All forms operative delivery are associated with an increased risk sepsis, National Institute for Health Care Excellence’s guidance recommends use prophylactic antibiotics at all caesarean deliveries, based on substantial randomised controlled trial evidence clinical effectiveness. A Cochrane review, updated 2017 (Liabsuetrakul T, Choobun Peeyananjarassri K, Islam QM. Antibiotic prophylaxis...
Introduction Adjudication of the primary outcome in randomised trials is thought to control misclassification. We investigated amount misclassification needed before adjudication changed trial results. Patients (or materials) and methods: included data from five stroke trials. Differential was introduced for each until estimated treatment effect altered. This simulated 1000 times. calculated between-simulation mean proportion participants that be differentially misclassified alter effect. In...
Abstract Background Existing guidelines recommend statisticians remain blinded to treatment allocation prior the final analysis and that any interim analyses should be conducted by a separate team from one undertaking analysis. However, there remains substantial variation in practice between UK Clinical Trials Units (CTUs) when it comes blinding statisticians. Therefore, aim of this study was develop guidance advise CTUs on risk-proportionate approach within clinical trials. Methods This...
To evaluate the cost-effectiveness of two rates enteral feed advancement (18 vs 30 mL/kg/day) in very preterm and low birth weight infants.
Loss to follow-up resulting in missing outcomes compromises the validity of trial results by reducing statistical power, negatively affecting generalisability and undermining assumptions made at analysis, leading potentially biased misleading results. Evidence that incentives are effective improving response rates exists, but there is little evidence regarding best approach, especially field perinatal medicine. The NIHR-funded SIFT infants 2 years age provided an ideal opportunity address...