Sian Noble

Dietary energy intake at the age of 4 months predicts postnatal weight gain and childhood body mass index

OBJECTIVE. Rapid infant weight gain has been shown to predict later obesity risk; however, it is unclear which factors influence infant diet and weight gain. The objective of this study was to determine whether different feeding patterns and energy intakes that are provided to infants affect body weight and BMI later in childhood. METHODS. This representative birth cohort study was conducted in the United Kingdom. Energy intake at age 4 months was estimated from 1-day unweighed dietary records in 881 infants and related to their childhood weight gain and BMI. RESULTS. Among formula- or mixed-fed infants (N = 582), energy intake was higher in first-born infants (mean ± SE: 2730 ± 29.4 kJ/day; n = 263) than in subsequent-born infants (2620.8 ± 25.2 kJ/day; n = 296). Energy intake at 4 months was also higher in infants who were given solid foods earlier (1–2 months: 2805.6 ± 50.4 kJ/day, n = 89; 2–3 months: 2658.6 ± 25.2 kJ/day, n = 339; 4+ months: 2587.2 ± 46.2 kJ/day, n = 111). Higher energy intake at 4 months predicted greater weight gain between birth to age 1, 2, or 3 years and larger body weight and BMI at ages 1 to 5 years. No significant associations were seen in breastfed infants (N = 299). CONCLUSIONS. Among formula- or mixed-fed infants, dietary energy intake at age 4 months predicted postnatal weight gain and childhood obesity risk. Both prenatal and postnatal factors may influence infant energy intake and postnatal weight gain.

Effect of intervention aimed at increasing physical activity, reducing sedentary behaviour, and increasing fruit and vegetable consumption in children: Active for Life Year 5 (AFLY5) school based cluster randomised controlled trial

Objective To investigate the effectiveness of a school based intervention to increase physical activity, reduce sedentary behaviour, and increase fruit and vegetable consumption in children. Design Cluster randomised controlled trial. Setting 60 primary schools in the south west of England. Participants Primary school children who were in school year 4 (age 8-9 years) at recruitment and baseline assessment, in year 5 during the intervention, and at the end of year 5 (age 9-10) at follow-up assessment. Intervention The Active for Life Year 5 (AFLY5) intervention consisted of teacher training, provision of lesson and child-parent interactive homework plans, all materials required for lessons and homework, and written materials for school newsletters and parents. The intervention was delivered when children were in school year 5 (age 9-10 years). Schools allocated to control received standard teaching. Main outcome measures The pre-specified primary outcomes were accelerometer assessed minutes of moderate to vigorous physical activity per day, accelerometer assessed minutes of sedentary behaviour per day, and reported daily consumption of servings of fruit and vegetables. Results 60 schools with more than 2221 children were recruited; valid data were available for fruit and vegetable consumption for 2121 children, for accelerometer assessed physical activity and sedentary behaviour for 1252 children, and for secondary outcomes for between 1825 and 2212 children for the main analyses. None of the three primary outcomes differed between children in schools allocated to the AFLY5 intervention and those allocated to the control group. The difference in means comparing the intervention group with the control group was –1.35 (95% confidence interval –5.29 to 2.59) minutes per day for moderate to vigorous physical activity, –0.11 (–9.71 to 9.49) minutes per day for sedentary behaviour, and 0.08 (–0.12 to 0.28) servings per day for fruit and vegetable consumption. The intervention was effective for three out of nine of the secondary outcomes after multiple testing was taken into account: self reported time spent in screen viewing at the weekend (–21 (–37 to –4) minutes per day), self reported servings of snacks per day (–0.22 (–0.38 to –0.05)), and servings of high energy drinks per day (–0.26 (–0.43 to –0.10)) were all reduced. Results from a series of sensitivity analyses testing different assumptions about missing data and from per protocol analyses produced similar results. Conclusion The findings suggest that the AFLY5 school based intervention is not effective at increasing levels of physical activity, decreasing sedentary behaviour, and increasing fruit and vegetable consumption in primary school children. Change in these activities may require more intensive behavioural interventions with children or upstream interventions at the family and societal level, as well as at the school environment level. These findings have relevance for researchers, policy makers, public health practitioners, and doctors who are involved in health promotion, policy making, and commissioning services. Trial registration Current Controlled Trials ISRCTN50133740.

Economic evaluation of a general practitioner with special interests led dermatology service in primary care

Abstract Objective To carry out an economic evaluation of a general practitioner with special interest service for non-urgent skin problems compared with hospital outpatient care. Design Cost effectiveness analysis and cost consequences analysis alongside a randomised controlled trial. Setting General practitioner with special interest dermatology service covering 29 general practices in Bristol. Participants Adults referred to a hospital dermatology clinic who were potentially suitable for management by a general practitioner with special interest. Interventions Participants were randomised 2:1 to receive either care by general practitioner with special interest service or usual hospital outpatient care. Main outcome measures Costs to NHS, patients, and companions, and costs of lost production. Cost effectiveness, using the two primary outcomes of dermatology life quality index scores and improved patient perceived access, was assessed by incremental cost effectiveness ratios and cost effectiveness acceptability curves. Cost consequences are presented in relation to all costs and both primary and secondary outcomes from the trial. Results Costs to the NHS for patients attending the general practitioner with special interest service were £208 (

Infant feeding in the second 6 months of life related to iron status: an observational study

361; euro 308) compared with £118 for hospital outpatient care. Based on analysis with imputation of missing data, costs to patients and companions were £48 and £51, respectively; costs of lost production were £27 and £34, respectively. The incremental cost effectiveness ratios for general practitioner with special interest care over outpatient care were £540 per one point gain in the dermatology life quality index and £66 per 10 point change in the access scale. Conclusions The general practitioner with special interest service for dermatology is more costly than hospital outpatient care, but this additional cost needs to be weighed against improved access and broadly similar health outcomes.

Impact of Helicobacter pylori eradication on dyspepsia, health resource use, and quality of life in the Bristol helicobacter project: randomised controlled trial

Objective: To investigate the relationship between iron status in infancy and type of milk and weaning solids consumed. Design: An observational cohort study. Setting: 928 term infants from the Avon Longitudinal Study of Parents and Children in 1993–94. Methods: Haemoglobin and ferritin concentrations at 8 and 12 months were assessed in relation to type and quantity of milk intake at 8 months. Results: By WHO criteria, 22.7% of the infants were anaemic at 8 months and 18.1% at 12 months. More breast- than formula-fed infants were anaemic at 8 and 12 months. Cows’ milk as the main drink was associated with increased anaemia at 12 months and low ferritin at 8 and 12 months. No association was found between any nutrients and haemoglobin concentrations. Protein and non-haem iron intakes were positively associated with ferritin concentrations and calcium intake negatively. This effect was more marked in infants being fed cows’ milk. More than 25% of infants in the breast milk and cows’ milk groups and 41% of infants having >6 breast feeds per day had iron intakes below the lower reference nutrient intake. Feeding cows’ milk or formula above 600 ml or >6 breast feeds per day was associated with lower intakes of solids. Conclusions: Both breast and cows’ milk feeding were associated with higher levels of anaemia. Satisfactory iron intake from solids in later infancy is more likely if formula intake is <600 ml per day and breast feeds are limited to <6 feeds per day. Cows’ milk should be strongly discouraged as a main drink before 12 months.

Resource-Use Measurement Based on Patient Recall: Issues and Challenges for Economic Evaluation

Abstract Objective To determine the impact of a community based Helicobacter pylori screening and eradication programme on the incidence of dyspepsia, resource use, and quality of life, including a cost consequences analysis. Design H pylori screening programme followed by randomised placebo controlled trial of eradication. Setting Seven general practices in southwest England. Participants 10 537 unselected people aged 20-59 years were screened for H pylori infection (13C urea breath test); 1558 of the 1636 participants who tested positive were randomised to H pylori eradication treatment or placebo, and 1539 (99%) were followed up for two years. Intervention Ranitidine bismuth citrate 400 mg and clarithromycin 500 mg twice daily for two weeks or placebo. Main outcome measures Primary care consultation rates for dyspepsia (defined as epigastric pain) two years after randomisation, with secondary outcomes of dyspepsia symptoms, resource use, NHS costs, and quality of life. Results In the eradication group, 35% fewer participants consulted for dyspepsia over two years compared with the placebo group (55/787 v 78/771; odds ratio 0.65, 95% confidence interval 0.46 to 0.94; P = 0.021; number needed to treat 30) and 29% fewer participants had regular symptoms (odds ratio 0.71, 0.56 to 0.90; P = 0.05). NHS costs were £84.70 (£74.90 to £93.91) greater per participant in the eradication group over two years, of which £83.40 (

Missing data in trial‐based cost‐effectiveness analysis: the current state of play

146; €121) was the cost of eradication treatment. No difference in quality of life existed between the two groups. Conclusions Community screening and eradication of H pylori is feasible in the general population and led to significant reductions in the number of people who consulted for dyspepsia and had symptoms two years after treatment. These benefits have to be balanced against the costs of eradication treatment, so a targeted eradication strategy in dyspeptic patients may be preferable.

The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer - the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial

Accurate resource-use measurement is challenging within an economic evaluation, but is a fundamental requirement for estimating efficiency. Considerable research effort has been concentrated on the appropriate measurement of outcomes and the policy implications of economic evaluation, while methods for resource-use measurement have been relatively neglected. Recently, the Database of Instruments for Resource Use Measurement (DIRUM) was set up at http://www.dirum.org to provide a repository where researchers can share resource-use measures and methods. A workshop to discuss the issues was held at the University of Birmingham in October 2011. Based on material presented at the workshop, this article highlights the state of the art of UK instruments for resource-use data collection based on patient recall. We consider methodological issues in the design and analysis of resource-use instruments, and the challenges associated with designing new questionnaires. We suggest a method of developing a good practice guideline, and identify some areas for future research. Consensus amongst health economists has yet to be reached on many aspects of resource-use measurement. We argue that researchers should now afford costing methodologies the same attention as outcome measurement, and we hope that this Current Opinion article will stimulate a debate on methods of resource-use data collection and establish a research agenda to improve the precision and accuracy of resource-use estimates.

The effect of local anaesthetic wound infiltration on chronic pain after lower limb joint replacement: A protocol for a double-blind randomised controlled trial

Randomised controlled trial (RCT)-based cost-effectiveness analyses, which are prone to missing data, are increasingly used in healthcare technology assessment. This has highlighted the need for appropriate methodological approaches to the handling of missing data. This paper reviews missing data methodology used in RCT-based cost-effectiveness analyses since 2003. Complete case analysis, which may lead to inappropriate conclusions, is still the most popular approach and its use has increased with time. The degree of missing data in cost-effectiveness analyses was often poorly reported and the methodology was often unclear. Reporting of missing data sensitivity analyses would improve article transparency.

Effect of a low-intensity psa-based screening intervention on prostate cancer mortality : The CAP randomized clinical trial

BackgroundThere is a need for evidence of the clinical effectiveness of minimally invasive surgery for the treatment of esophageal cancer, but randomized controlled trials in surgery are often difficult to conduct. The ROMIO (Randomized Open or Minimally Invasive Oesophagectomy) study will establish the feasibility of a main trial which will examine the clinical and cost-effectiveness of minimally invasive and open surgical procedures for the treatment of esophageal cancer.Methods/DesignA pilot randomized controlled trial (RCT), in two centers (University Hospitals Bristol NHS Foundation Trust and Plymouth Hospitals NHS Trust) will examine numbers of incident and eligible patients who consent to participate in the ROMIO study. Interventions will include esophagectomy by: (1) open gastric mobilization and right thoracotomy, (2) laparoscopic gastric mobilization and right thoracotomy, and (3) totally minimally invasive surgery (in the Bristol center only). The primary outcomes of the feasibility study will be measures of recruitment, successful development of methods to monitor quality of surgery and fidelity to a surgical protocol, and development of a core outcome set to evaluate esophageal cancer surgery. The study will test patient-reported outcomes measures to assess recovery, methods to blind participants, assessments of surgical morbidity, and methods to capture cost and resource use. ROMIO will integrate methods to monitor and improve recruitment using audio recordings of consultations between recruiting surgeons, nurses, and patients to provide feedback for recruiting staff.DiscussionThe ROMIO study aims to establish efficient methods to undertake a main trial of minimally invasive surgery versus open surgery for esophageal cancer.Trial registrationThe pilot trial has Current Controlled Trials registration number ISRCTN59036820(25/02/2013) at http://www.controlled-trials.com; the ROMIO trial record at that site gives a link to the original version of the study protocol.