Traditional dietary assessment methods, used in the UK, such as weighed food diaries impose a large participant burden, often resulting in difficulty recruiting representative samples and ...underreporting of energy intakes. One approach to reducing the burden placed on the participant is to use portion size assessment tools to obtain an estimate of the amount of food consumed, removing the need to weigh all foods. An age range specific food atlas was developed for use in assessing children's dietary intakes. The foods selected and portion sizes depicted were derived from intakes recorded during the UK National Diet and Nutrition Surveys of children aged 1.5 to 16 years. Estimates of food portion sizes using the food atlas were compared against 4-day weighed intakes along with in-school / nursery observations, by the research team. Interviews were conducted with parents the day after completion of the diary, and for children aged 4 to 16 years, also with the child. Mean estimates of portion size consumed were within 7% of the weight of food recorded in the weighed food diary. The limits of agreement were wide indicating high variability of estimates at the individual level but the precision increased with increasing age. For children 11 years and over, agreement with weighed food diaries, was as good as that of their parents in terms of total weight of food consumed and of intake of energy and key nutrients. The age appropriate food photographs offer an alternative to weighed intakes for dietary assessment with children.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Abstract
Complete case analyses of complete crossover designs provide an opportunity to make comparisons based on patients who can tolerate all treatments. It is argued that this provides a means of ...estimating a principal stratum strategy estimand, something which is difficult to do in parallel group trials. While some trial users will consider this a relevant aim, others may be interested in hypothetical strategy estimands, that is, the effect that would be found if all patients completed the trial. Whether these estimands differ importantly is a question of interest to the different users of the trial results. This paper derives the difference between principal stratum strategy and hypothetical strategy estimands, where the former is estimated by a complete-case analysis of the crossover design, and a model for the dropout process is assumed. Complete crossover designs, that is, those where all treatments appear in all sequences, and which compare t treatments over p periods with respect to a continuous outcome are considered. Numerical results are presented for Williams designs with four and six periods. Results from a trial of obstructive sleep apnoea-hypopnoea (TOMADO) are also used for illustration. The results demonstrate that the percentage difference between the estimands is modest, exceeding 5% only when the trial has been severely affected by dropouts or if the within-subject correlation is low.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
3.
Peter Armitage 1924–2024 Matthews, John N S
Journal of the Royal Statistical Society. Series A, Statistics in society,
04/2024
Journal Article
Peer reviewed
Open access
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BFBNIB, FZAB, GIS, IJS, INZLJ, KILJ, NLZOH, NMLJ, NUK, OILJ, PNG, SAZU, SBCE, SBMB, UL, UM, UPUK, ZRSKP
Background
To compare the efficacy of the Newcastle infant dialysis and ultrafiltration system (Nidus) with peritoneal dialysis (PD) and conventional haemodialysis (HD) in infants weighing <8 kg.
...Methods
We compared the urea, creatinine and phosphate clearances, the ultrafiltration precision, and the safety of the Nidus machine with PD in 7 piglets weighing 1–8 kg, in a planned randomised cross-over trial in babies, and in babies for whom no other therapy existed, some of whom later graduated to conventional HD.
Results
Two babies entered the randomised trial; 1 recovered rapidly on PD, the other remained on the Nidus as PD failed. Additionally, 9 babies were treated on the Nidus on humanitarian grounds: 3 because of failed PD, and 3 with permanent kidney failure later converted to conventional HD. We haemodialysed 10 babies weighing between 1.8 and 5.9 kg for 2,475 h during 354 Nidus sessions without any clinically important incidents, and without detectable haemolysis. Single-lumen vascular access was used with no blood priming of circuits. The urea, creatinine and phosphate clearances using the Nidus were around 1.5 to 2.0 ml/min in piglets and babies, and were consistently higher than PD clearances, which ranged from about 0.2 to 0.8 ml/min (
p
≤ 0.0002 for each chemical). Ultrafiltration was achieved to microlitre precision by the Nidus, but varied widely with PD. Fluid removal using conventional HD was imprecise and resulted in some hypovolaemic episodes requiring correction.
Conclusion
The Nidus can provide HD in the Pediatric Intensive Care Unit (PICU) and outpatient intermittent HD without blood priming for babies weighing <8 kg, It generates higher dialysis clearances than PD, and delivers more precise ultrafiltration control than either PD or conventional HD.
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DOBA, EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, IZUM, KILJ, KISLJ, MFDPS, NLZOH, NUK, OBVAL, OILJ, PILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, SIK, UILJ, UKNU, UL, UM, UPUK, VKSCE, VSZLJ, ZAGLJ
The stepped wedge design (SWD) is a form of cluster randomized trial, usually comparing two treatments, which is divided into time periods and sequences, with clusters allocated to sequences. ...Typically all sequences start with the standard treatment and end with the new treatment, with the change happening at different times in the different sequences. The clusters will usually differ in size but this is overlooked in much of the existing literature. This paper considers the case when clusters have different sizes and determines how efficient designs can be found. The approach uses an approximation to the variance of the treatment effect, which is expressed in terms of the proportions of clusters and of individuals allocated to each sequence of the design. The roles of these sets of proportions in determining an efficient design are discussed and illustrated using two SWDs, one in the treatment of sexually transmitted diseases and one in renal replacement therapy. Cluster‐balanced designs, which allocate equal numbers of clusters to each sequence, are shown to have excellent statistical and practical properties; suggestions are made about the practical application of the results for these designs. The paper concentrates on the cross‐sectional case, where subjects are measured once, but it is briefly indicated how the methods can be extended to the closed‐cohort design.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
In 2005, the nutritional content of children's school lunches in England was widely criticised, leading to a major policy change in 2006. Food and nutrient-based standards were reintroduced requiring ...primary schools to comply by September 2008. We aimed to determine the effect of the policy on the nutritional content at lunchtime and in children's total diet. We undertook a natural experimental evaluation, analysing data from cross-sectional surveys in 12 primary schools in North East England, pre and post policy. Dietary data were collected on four consecutive days from children aged 4-7 years (n = 385 in 2003-4; n = 632 in 2008-9). We used linear mixed effect models to analyse the effects of gender, year, and lunch type on children's mean total daily intake. Both pre- and post-implementation, children who ate a school lunch consumed less sodium (mean change -128 mg, 95% CI: -183 to -73 mg) in their total diet than children eating home-packed lunches. Post-implementation, children eating school lunches consumed a lower % energy from fat (-1.8%, -2.8 to -0.9) and saturated fat (-1.0%; -1.6 to -0.5) than children eating packed lunches. Children eating school lunches post implementation consumed significantly more carbohydrate (16.4 g, 5.3 to 27.6), protein (3.6 g, 1.1 to 6.0), non-starch polysaccharides (1.5 g, 0.5 to 1.9), vitamin C (0.7 mg, 0.6 to 0.8), and folate (12.3 µg, 9.7 to 20.4) in their total diet than children eating packed lunches. Implementation of school food policy standards was associated with significant improvements in the nutritional content of school lunches; this was reflected in children's total diet. School food- and nutrient-based standards can play an important role in promoting dietary health and may contribute to tackling childhood obesity. Similar policy measures should be considered for other environments influencing children's diet.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Online dietary assessment tools offer a convenient, low cost alternative to traditional dietary assessment methods such as weighed records and face-to-face interviewer-led 24-h recalls. INTAKE24 is ...an online multiple pass 24-h recall tool developed for use with 11-24 year-old. The aim of the study was to undertake a comparison of INTAKE24 (the test method) with interviewer-led multiple pass 24-h recalls (the comparison method) in 180 people aged 11-24 years. Each participant completed both an INTAKE24 24-h recall and an interviewer-led 24-h recall on the same day on four occasions over a one-month period. The daily energy and nutrient intakes reported in INTAKE24 were compared to those reported in the interviewer-led recall. Mean intakes reported using INTAKE24 were similar to the intakes reported in the interviewer-led recall for energy and macronutrients. INTAKE24 was found to underestimate energy intake by 1% on average compared to the interviewer-led recall with the limits of agreement ranging from minus 49% to plus 93%. Mean intakes of all macronutrients and micronutrients (except non-milk extrinsic sugars) were within 4% of the interviewer-led recall. Dietary assessment that utilises technology may offer a viable alternative and be more engaging than paper based methods, particularly for children and young adults.
Objective To test whether active management of urinary tract infections (UTI) in young children by general practitioners can reduce kidney scarring rates. Design A comparison of two audits in ...Newcastle, of children aged <8 years, presenting with UTIs ; a retrospective audit of conventional management during 1992–1995 (1990s) versus a prospective audit of direct access management during 2004–2011 (2000s). Main outcome measures Kidney scarring rates, and their relationship with time-to-treat. Results Children with a first UTI in the 2000s compared to those in the 1990s, were referred younger, were half as likely to have a renal scar (girls OR 0.47, 95% CI 0.29 to 0.76; boys 0.35, 0.16 to 0.81), and were about 12 times more likely to have vesicoureteric reflux without scarring (girls 11.9, 4.3 to 33.5; boys 14.4, 4.3 to 47.6). In the 2000s, general practitioners treated about half the children at first consultation. Children who were treated within 3 days of their symptoms starting were one-third as likely to scar as those whose symptoms lasted longer (0.33, 0.12 to 0.72). Interpretation Most kidney defects seen in children after UTIs, are acquired scars, and in Newcastle, active management in primary care has halved this rate.
Remission rates in young people with Graves hyperthyroidism are less than 25% after 2 years of thionamide antithyroid drug (ATD).
We explored whether rituximab (RTX), a B-lymphocyte-depleting agent, ...would increase remission rates when administered with a short course of ATD.
This was an open-label, multicenter, single-arm, phase 2 trial in young people (ages, 12-20 years) with Graves hyperthyroidism. An A'Hern design was used to distinguish an encouraging remission rate (40%) from an unacceptable rate (20%). Participants presenting with Graves hyperthyroidism received 500 mg RTX and 12 months of ATD titrated according to thyroid function. ATDs were stopped after 12 months and primary outcome assessed at 24 months. Participants had relapsed at 24 months if thyrotropin was suppressed and free 3,5,3'-triiodothyronine was raised; they had received ATD between months 12 and 24; or they had thyroid surgery/radioiodine.
A total of 27 participants were recruited and completed the trial with no serious side effects linked to treatment. Daily carbimazole dose at 12 months was less than 5 mg in 21 of 27 participants. Thirteen of 27 participants were in remission at 24 months (48%, 90% one-sided CI, 35%-100%); this exceeded the critical value (9) for the A'Hern design and provided evidence of a promising remission rate. B-lymphocyte count at 28 weeks, expressed as a percentage of baseline, was related to likelihood of remission.
Adjuvant RTX, administered with a 12-month course of ATD, may increase the likelihood of remission in young people with Graves hyperthyroidism. A randomized trial of adjuvant RTX in young people with Graves hyperthyroidism is warranted.
Limited research exists on the effectiveness of product placement in secondary schools. We explored the impact of re-positioning sweet-baked goods, fruit, sugar-sweetened beverages (SSBs) and water ...on pupil's lunchtime purchases in two secondary schools in North-East England. We employed a stepped-wedge design with two clusters and four time periods. The intervention(s) involved re-positioning selected food and drinks to increase and decrease accessibility of 'healthier' and 'less healthy' items, respectively. Unidentifiable smartcard data measured the change in number of pupil's purchasing the above items. McNemar tests were undertaken on paired nominal data in Stata(v15). In School A, pupils purchasing fruit pots from control to intervention increased (
= 0 cf.
= 81; OR 0, 95% CI 0 to 0.04); post-intervention, this was not maintained. In School B, from control to intervention pupil's purchasing sweet-baked goods decreased (
= 183 cf.
= 147; OR 1.2, 95% CI 1 to 1.6). This continued post-intervention (
= 161 cf.
= 122; OR 1.3, 95% CI 1.0 to 1.7) and was similar for SSBs (
= 180 cf.
= 79; OR 2.3, 95% CI 1.7 to 3.0). We found no evidence of other changes. There is some evidence that product placement may positively affect pupil's food and drink purchases. However, there are additional aspects to consider, such as, product availability, engaging canteen staff and the individual school context.
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