Showing papers by "Tracy E Roberts published in 2017"

Effect of diet and physical activity based interventions in pregnancy on gestational weight gain and pregnancy outcomes: meta-analysis of individual participant data from randomised trials

Abstract: National Institute for Health Research (NIHR) Health Technology Assessment) programme (No 12/01/50)

Effects of antenatal diet and physical activity on maternal and fetal outcomes: Individual patient data meta-analysis and health economic evaluation

Abstract: Background: Diet- and physical activity-based interventions in pregnancy have the potential to alter maternal and child outcomes. Objectives: To assess whether or not the effects of diet and lifestyle interventions vary in subgroups of women, based on maternal body mass index (BMI), age, parity, Caucasian ethnicity and underlying medical condition(s), by undertaking an individual patient data (IPD) meta-analysis. We also evaluated the association of gestational weight gain (GWG) with adverse pregnancy outcomes and assessed the cost-effectiveness of the interventions. Data sources: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects and Health Technology Assessment database were searched from October 2013 to March 2015 (to update a previous search). Review methods: Researchers from the International Weight Management in Pregnancy Collaborative Network shared the primary data. For each intervention type and outcome, we performed a two-step IPD random-effects meta-analysis, for all women (except underweight) combined and for each subgroup of interest, to obtain summary estimates of effects and 95% confidence intervals (CIs), and synthesised the differences in effects between subgroups. In the first stage, we fitted a linear regression adjusted for baseline (for continuous outcomes) or a logistic regression model (for binary outcomes) in each study separately; estimates were combined across studies using random-effects meta-analysis models. We quantified the relationship between weight gain and complications, and undertook a decision-analytic model-based economic evaluation to assess the cost-effectiveness of the interventions. Results: Diet and lifestyle interventions reduced GWG by an average of 0.70 kg (95% CI-0.92 to-0.48 kg; 33 studies, 9320 women). The effects on composite maternal outcome [summary odds ratio (OR) 0.90, 95% CI 0.79 to 1.03; 24 studies, 8852 women] and composite fetal/neonatal outcome (summary OR 0.94, 95% CI 0.83 to 1.08; 18 studies, 7981 women) were not significant. The effect did not vary with baseline BMI, age, ethnicity, parity or underlying medical conditions for GWG, and composite maternal and fetal outcomes. Lifestyle interventions reduce Caesarean sections (OR 0.91, 95% CI 0.83 to 0.99), but not other individual maternal outcomes such as gestational diabetes mellitus (OR 0.89, 95% CI 0.72 to 1.10), pre-eclampsia or pregnancy-induced hypertension (OR 0.95, 95% CI 0.78 to 1.16) and preterm birth (OR 0.94, 95% CI 0.78 to 1.13). There was no significant effect on fetal outcomes. The interventions were not cost-effective. GWG, including adherence to the Institute of Medicine-recommended targets, was not associated with a reduction in complications. Predictors of GWG were maternal age (summary estimate-0.10 kg, 95% CI-0.14 to-0.06 kg) and multiparity (summary estimate-0.73 kg, 95% CI-1.24 to-0.23 kg). Limitations: The findings were limited by the lack of standardisation in the components of intervention, residual heterogeneity in effects across studies for most analyses and the unavailability of IPD in some studies. Conclusion: Diet and lifestyle interventions in pregnancy are clinically effective in reducing GWG irrespective of risk factors, with no effects on composite maternal and fetal outcomes. Future work: The differential effects of lifestyle interventions on individual pregnancy outcomes need evaluation. Study registration: This study is registered as PROSPERO CRD42013003804.

Applications of the capability approach in the health field: a literature review

Abstract: The primary aims of this review are to document capability applications in the health field and to explore the objectives and decision-rules of studies measuring capability more broadly. Relevant studies are identified using a literature search strategy known as "comprehensive pearl growing". All studies with a primary focus on health are assessed individually, whilst a summary narrative analysis of the full review examines the objectives of capability studies. Four distinct groups in the health field are identified in the review: (1) physical activity and diet; (2) patient empowerment; (3) multidimensional poverty and (4) assessments of health and social care interventions. Different approaches to applying mixed methods, selecting capability dimensions and weighting capabilities are found across studies. There is a noticeable non-reliance on health status as a sole indicator of capability in health. In terms of objectives of studies measuring capability, although there is a lack of consistency, an objective related to sufficiency of capabilities appeared most often in the studies found in this review. Even though one of the appeals of the capability perspective is its underspecified nature, this review highlights the challenge of finding a coherent alternative to more established approaches of evaluation.

Cell salvage and donor blood transfusion during cesarean section: A pragmatic, multicentre randomised controlled trial (SALVO).

Abstract: Background: Excessive haemorrhage at caesarean section requires donor (allogeneic) blood transfusion. Cell 34 salvage may reduce this requirement. Methods and findings: We conducted a pragmatic randomised controlled trial (26 obstetric units; June 2013 through April 2016) of routine cell salvage use (intervention) vs. current standard of care without routine salvage use (control) in caesarean section among women at risk of haemorrhage. Randomisation was stratified, using random permuted blocks of variable sizes. In an intention-to-treat analysis, we used multivariable models, adjusting for stratification variables and prognostic factors identified a priori, to compare rates of donor blood transfusion (primary outcome) and fetomaternal haemorrhage ≥2ml in RhD-negative women with RhD-positive baby (a secondary outcome) between groups. Among 3028 women randomised (2990 analysed), 95.6% of 1498 assigned to intervention had cell salvage deployed (50.8% had salvaged blood returned; mean 259.9 ml) vs. 3.9% of 1492 assigned to control. Donor blood transfusion rates were 3.5% in the control group vs. 2.5% in intervention (adjusted odds ratio [OR] 0.65, 95% confidence interval [CI] 0.42 to 1.01, p=0.056; adjusted risk difference -1.03, 95% CI -2.13 to 0.06; number needed to treat [NNT] 97, at the lower limit of 95% confidence NNT was 47 and at the upper limit the number needed to harm was 1,667). In a planned subgroup analysis, the transfusion rate was 4.6% in women assigned to control vs. 3.0% in the intervention group among emergency caesareans (adjusted OR 0.58, 95% CI 0.34 to 0.99), whereas it was 2.2% vs. 1.8% among elective caesareans (adjusted OR 0.83, 95% CI 0.38 to 1.83) (interaction p=0.46). No case of amniotic fluid embolism was observed. Fetomaternal haemorrhage was higher with intervention (10.5% in control vs. 25.6% in intervention, adjusted OR 5.63, 95% CI 1.43 to 22.14, p=0.013). We are unable to comment on long-term antibody sensitisation effects. Conclusions: The overall reduction observed in donor blood transfusion associated with the routine use of cell salvage during caesarean section was not statistically significant.

Systematic review of pathways for the delivery of allergy services

Abstract: Objectives The incidence and prevalence of allergies worldwide has been increasing and allergy services globally are unable to keep up with this increase in demand. This systematic review aims to understand the delivery of allergy services worldwide, challenges faced and future directions for service delivery. Methods A systematic scoping review of Ovid, EMBASE, HMIC, CINAHL, Cochrane, DARE, NHS EED and INAHTA databases was carried out using predefined inclusion and exclusion criteria. Data on the geographical region, study design and treatment pathways described were collected, and the findings were narratively reported. This review followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Results 205 publications were screened and 27 selected for review. Only 3 were prospective studies, and none included a control group. There were no eligible publications identified from North America, Africa, Australia and most parts of Asia. Most publications relate to allergy services in the UK. In general, allergy services globally appear not to have kept pace with increasing demand. The review suggests that primary care practitioners are not being adequately trained in allergy and that there is a paucity of appropriately trained specialists, especially in paediatric allergy. There appear to be considerable barriers to service improvement, including lack of political will and reluctance to allocate funds from local budgets. Conclusions Demand for allergy services appears to have significantly outpaced supply. Primary and secondary care pathways in allergy seem inadequate leading to poor referral practices, delays in patient management and consequently poor outcomes. Improvement of services requires strong public and political engagement. There is a need for well-planned, prospective studies in this area and a few are currently underway. There is no evidence to suggest that any given pathway of service provision is better than another although data from a few long-term, prospective studies look very promising.

Should we screen for the sexually-transmitted infection Mycoplasma genitalium? Evidence synthesis using a transmission-dynamic model.

Abstract: There is increasing concern about Mycoplasma genitalium as a cause of urethritis, cervicitis, pelvic inflammatory disease (PID), infertility and ectopic pregnancy. Commercial nucleic acid amplification tests (NAATs) are becoming available, and their use in screening for M. genitalium has been advocated, but M. genitalium's natural history is poorly-understood, making screening's effectiveness unclear. We used a transmission-dynamic compartmental model to synthesise evidence from surveillance data and epidemiological and behavioural studies to better understand M. genitalium's natural history, and then examined the effects of implementing NAAT testing. Introducing NAAT testing initially increases diagnoses, by finding a larger proportion of infections; subsequently the diagnosis rate falls, due to reduced incidence. Testing only symptomatic patients finds relatively little infection in women, as a large proportion is asymptomatic. Testing both symptomatic and asymptomatic patients has a much larger impact and reduces cumulative PID incidence in women due to M. genitalium by 31.1% (95% range:13.0%-52.0%) over 20 years. However, there is important uncertainty in M. genitalium's natural history parameters, leading to uncertainty in the absolute reduction in PID and sequelae. Empirical work is required to improve understanding of key aspects of M. genitalium's natural history before it will be possible to determine the effectiveness of screening.

The Speed of Increasing milk Feeds : a randomised controlled trial

Abstract: In the UK, 1–2% of infants are born very preterm (<32 weeks of gestation) or have very low birth weight (<1500 g). Very preterm infants are initially unable to be fed nutritional volumes of milk and therefore require intravenous nutrition. Milk feeding strategies influence several long and short term health outcomes including growth, survival, infection (associated with intravenous nutrition) and necrotising enterocolitis (NEC); with both infection and NEC being key predictive factors of long term disability. Currently there is no consistent strategy for feeding preterm infants across the UK. The SIFT trial will test two speeds of increasing milk feeds with the primary aim of determining effects on survival without moderate or severe neurodevelopmental disability at 24 months of age, corrected for prematurity. The trial will also examine many secondary outcomes including infection, NEC, time taken to reach full feeds and growth. Two thousand eight hundred very preterm or very low birth weight infants will be recruited from approximately 30 hospitals across the UK to a randomised controlled trial. Infants with severe congenital anomaly or no realistic chance of survival will be excluded. Infants will be randomly allocated to either a faster (30 ml/kg/day) or slower (18 ml/kg/day) rate of increase in milk feeds. Data will be collected during the neonatal hospital stay on weight, infection rates, episodes of NEC, length of stay and time to reach full milk feeds. Long term health outcomes comprising vision, hearing, motor and cognitive impairment will be assessed at 24 months of age (corrected for prematurity) using a parent report questionnaire. Extensive searches have found no active or proposed studies investigating the rate of increasing milk feeds. The results of this trial will have importance for optimising incremental milk feeding for very preterm and/or very low birth weight infants. No additional resources will be required to implement an optimal feeding strategy, and therefore if successful, the trial results could rapidly be adopted across the NHS at low cost. ISRCTN Registry; ISRCTN76463425 on 5 March, 2013.

Prescription rates of adrenaline auto-injectors for children in UK general practice: a retrospective cohort study

Abstract: BACKGROUND Adrenaline auto-injectors (AAI) should be provided to individuals considered to be at high risk of anaphylaxis. There is some evidence that the rate of AAI prescription is increasing, but the true extent has not been previously quantified. AIM To estimate the trends in annual GP-issued prescriptions for AAI among UK children between 2000 and 2012. DESIGN AND SETTING Retrospective cohort study using data from primary care practices that contributed to The Health Improvement Network (THIN) database. METHOD Children and young people aged between 0-17 years of age with a prescription for AAIs were identified, and annual AAI device prescription rates were estimated using Stata (version 12). RESULTS A total of 1.06 million UK children were identified, providing 5.1 million person years of follow-up data. Overall, 23 837 children were deemed high risk by their GPs, and were prescribed 98 737 AAI devices. This equates to 4.67 children (95% confidence interval [CI] = 4.66 to 4.69), and 19.4 (95% CI = 19.2 to 19.5) devices per 1000 person years. Between 2000 and 2012, there has been a 355% increase in the number of children prescribed devices, and a 506% increase in the total number of AAI devices prescribed per 1000 person years in the UK. The number of devices issued per high-risk child during this period has also increased by 33%. CONCLUSION The number of children being prescribed AAI devices and the number of devices being prescribed in UK primary care between 2000 and 2012 has significantly increased. A discussion to promote rational prescribing of AAIs in the NHS is needed.

Confusion Over Differences in Registration and Randomization Criteria for the LORIS (Low-Risk DCIS) Trial.

Abstract: Daniel Rea, BSc, MBBS, PhD, FRCP, Adele Francis, MBChB, PhD, FRCS, Matthew Wallis, MBChB, FRCR, Jeremy Thomas, FRCPath, John Bartlett, BSc, PhD, FRCPath, Sarah Bowden, PhD, BSc, David Dodwell, MD, Lesley Fallowfield, DBE, BSc, DPhil, F.Med.Sci., Claire Gaunt, BSc (Hons), Andrew Hanby, BM, FRCPath, Valerie Jenkins, DPhil, BSc, SRN, Lucy Matthews, BSc (Hons), Sarah Pinder, FRCPath, Sarah Pirrie, MSc, Malcolm Reed, MD, FRCS, Margaret Wilcox, Tracy Roberts, PhD, Cliona Kirwan, MBBS, BSc, FRCS, PhD, Cassandra Brookes, BSc (Hons), MSc, Patricia Fairbrother, Lucinda Billingham, BSc, MSc, PhD, CStat, Andrew Evans, FRCR, and Jennie Young, BA (Hons)

LB1.5 The efficacy and safety of gentamicin for the treatment of genital, pharyngeal and rectal gonorrhoea: a randomised controlled trial

Abstract: Introduction Gentamicin is effective against N. gonorrhoeaein vitro and systematic reviews have reported cure rates of 62%–98% but the quality of studies was low and there are few data on pharyngeal or rectal infections. A recent large non comparative trial reported a cure rate of 100% when gentamicin was combined with 2g oral azithromycin, but a high incidence of gastrointestinal adverse effects limited tolerability and few extra-genital infections were included. The aim of this study was to evaluate the efficacy and safety of gentamicin versus ceftriaxone, each combined with 1g of azithromycin, for the treatment of gonorrhoea. Methods A multi-centre, blinded, randomised controlled trial in participants with genital, pharyngeal or rectal gonorrhoea who received either gentamicin 240 mg or ceftriaxone 500 mg (each as a single intramuscular injection). The diagnosis of gonorrhoea was based on a positive nucleic acid amplification test (NAAT) or gram stained smear on microscopy. The primary endpoint was microbiological cure based on NAAT two weeks after treatment. The trial had 90% power to detect non-inferiority with a lower CI for an absolute risk difference of 5%. Data collection was completed in March 2017. Results 720 patients from 14 sexual health clinics in England were randomised to receive ceftriaxone (n=362) or gentamicin (n=358). Baseline characteristics of the two groups were well balanced. 306 participants randomised to ceftriaxone (85%) and 292 randomised to gentamicin (82%) had primary outcome data available. 98% (299/306) and 91% (267/292) of participants randomised respectively had clearance of gonorrhoea at 2 weeks – adjusted risk difference −6.4% (95% CI −10.4%, −2.4%). Pre-specified sensitivity analyses supported this result. Clearance at the genital site was 98% and 94%, at pharynx 96% and 80% and at rectum 98% and 90%. The frequency of side effects was similar between treatment groups. Conclusion Gentamicin is not non-inferior to ceftriaxone for the treatment of gonorrhoea.

Time to tighten the belts? Exploring the relationship between savings and obesity.

Abstract: Background Literature suggests that the higher the rate of time preference people have, the less likely they are to save for the future. Likewise, it has been hypothesised that rising rates of being overweight/obesity are associated with an increase in peoples' marginal rate of time preference. Aim To investigate the relationship between being overweight/ obese and the rate of time preference in an older English population, using savings as a proxy for time preference. Methods Three different econometric methods-Random-effects Probit Estimation, Fixed-effects Estimation, and Generalised Method of Moments Estimation-were used to explore the link between being overweight/ obese and rate of time preference in the English Longitudinal Study of Ageing dataset. Six waves of panel data spanning eleven years provided the data to test whether savings variables are related to being overweight/ obese. Results The decision to save was shown to hold a statistically significant negative relationship with body mass index but only in the Generalised Method of Moments model. Placing savings in safe, low risk investments was significantly related to a lower probability of being obese but only in the random-effects Probit model. The proportion that people saved relative to their income was not found to be significantly associated with the probability of being overweight/ obese in any of the models. Conclusion There is an unclear relationship between saving behaviour and being overweight/ obese in an older English population. A financial variable such as savings is a potentially appropriate but imperfect proxy for the rate of time preference of the population. Further research is required to clarify the relationship in order to help develop strategies for obesity prevention. The inconsistency in the results between methods highlights the importance of using a wide range of alternative techniques before implementing important policy decisions.

Methods for Evaluating Medical Tests and Biomarkers

Abstract: Joris de Groot, Christiana Naaktgeboren, Hans Reitsma, Carl Moons Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, 3584 CG Utrecht, Netherlands Correspondence: Joris de Groot (j.degroot-17@umcutrecht.nl) A major contributor to the rising problem of overdiagnosis, with the subsequent risk of overtreatment, is the development of highly sensitive diagnostic technologies that challenge and sometimes expand prevailing disease definitions. Although the value of such new technology might be that it identifies new, milder, earlier or even other abnormalities, it is uncertain whether these “abnormalities” provide the same diagnostic and prognostic information, or require the same treatment as the original targeted disease. It is often unclear which of the newly detected abnormalities are benign and how many people might be diagnosed and treated unnecessarily as a result of widespread introduction of the new test. Failure to investigate the clinical relevance of broadening disease definitions which include these newly detected abnormalities may therefore lead to overdiagnosis and overtreatment. Spiral CT used in diagnosing pulmonary embolism, detecting small subsegmental embolisms, has been mentioned as an example of such situation. On-going technological advancements in medicine will only further increase the development of new diagnostic technologies that challenge existing disease definitions. We show why traditional cross-sectional diagnostic accuracy studies are insufficient to evaluate such new tests and how methodology for assessing their performance should catch up and keep pace with present-day technological developments. It is crucial to improve data analysis and presentation of current diagnostic studies, to make better use of existing data, or ultimately perform test-treatment trials to answer the question whether introduction of a new high sensitive test will in fact improve patient relevant outcomes, or rather induce overdiagnosis and overtreatment.

Sensitivity to scale of willingness-to-pay within the context of menorrhagia

Abstract: Objectives: Willingness-to-pay (WTP) provides a broad assessment of well-being, capturing benefits beyond health. However, the validity of the approach has been questioned and the evidence relating to the sensitivity of WTP to changes in health status is mixed. Using menorrhagia (heavy menstrual bleeding) as a case study, this exploratory study assesses the sensitivity to scale of WTP to change in health status as measured by a condition-specific measure, MMAS, which includes both health and non-health benefits. The relationship between EQ-5D and change in health status is also assessed. Methods: Baseline EQ-5D and MMAS values were collected from women taking part in a randomized controlled trial for pharmaceutical treatment of menorrhagia. Following treatment, these measures were administered along with a WTP exercise. The relationship between the measures was assessed using Spearman's correlation analysis, and the sensitivity to scale of WTP was measured by identifying differences in WTP alongside differences in MMAS and EQ5D values. Results: Our exploratory findings indicated that WTP, and not EQ-5D, was significantly positively correlated with change in MMAS, providing some evidence for convergent validity. These findings suggest that WTP is capturing the non-health benefits within the MMAS measure. Mean WTP also increased with percentage improvements in MMAS, suggesting sensitivity to scale. Conclusion: When compared to quality of life measured using the condition-specific MMAS measure, the convergent validity and sensitivity to scale of WTP is indicated. The findings suggest that WTP is more sensitive to change in MMAS, than with EQ-5D.

Antiepileptic drug management in pregnancy: A double blind randomised trial on effectiveness and acceptability of monitoring strategies (EMPIRE study)

Abstract: ........................................................................................................................... 3 TABLE OF CONTENTS ...................................................................................................... 6 LIST OF TABLES ................................................................................................................. 9 LIST OF FIGURES ............................................................................................................. 11 GLOSSARY OF TERMS AND ABBREVIATIONS ....................................................... 12 PLAIN ENGLISH SUMMARY.......................................................................................... 14 SCIENTIFIC SUMMARY .................................................................................................. 15 CHAPTER

Erratum to: Methods for evaluating medical tests and biomarkers.

Abstract: [This corrects the article DOI: 10.1186/s41512-016-0001-y.].