BackgroundChildren and young people with neurodisability often need help to achieve socially acce... more BackgroundChildren and young people with neurodisability often need help to achieve socially acceptable bladder and bowel control. Approaches vary depending on whether or not the impairment results from spinal cord pathology that impairs motor control and sensation of the bladder and bowel. Currently, there is uncertainty about which interventions are effective.ObjectiveThe objective was to summarise the available evidence on and current practice for improving continence in children and young people with neurodisability.DesignA systematic review of the effectiveness, cost-effectiveness and factors that modify intervention implementation, alongside a cross-sectional, online survey of current practice with health professionals, parent carers, school and care staff and young people with neurodisability.ResultsTwelve databases were searched in the review, resulting in 5756 references; 71 studies (72 papers) were included in the analyses. Most of the evidence was for children with spinal...
ObjectivesParent carers of children with special educational needs or disability are at risk of p... more ObjectivesParent carers of children with special educational needs or disability are at risk of poorer mental and physical health. In response to these needs, we codeveloped the ‘Healthy Parent Carers’ (HPC) programme. This study examined the views and experiences of participants in the HPC feasibility trial to inform programme refinement.Intervention, setting and participantsHPC is a peer-led group-based intervention (supported by online materials) for primary carers of disabled children, encouraging behaviours linked with health and well-being. It was delivered by two lead and six assistant peer facilitators in six community sites (one lead and one assistant per group) in South West England over six or 12 sessions. Control participants had online materials only. The trial involved 47 intervention and 45 control parent carers (97% female and 97% white) and eight facilitators (one male).DesignA preplanned mixed methods process evaluation using questionnaires and checklists (during a...
BackgroundApproximately one-third of children in England leave primary school overweight or obese... more BackgroundApproximately one-third of children in England leave primary school overweight or obese. There is little evidence of effective obesity prevention programmes for children in this age group.ObjectiveTo determine the effectiveness and cost-effectiveness of a school-based healthy lifestyles programme in preventing obesity in children aged 9–10 years.DesignA cluster randomised controlled trial with an economic and process evaluation.SettingThirty-two primary schools in south-west England.ParticipantsChildren in Year 5 (aged 9–10 years) at recruitment and in Year 7 (aged 11–12 years) at 24 months’ post-baseline follow-up.InterventionThe Healthy Lifestyles Programme (HeLP) ran during the spring and summer terms of Year 5 into the autumn term of Year 6 and included four phases: (1) building a receptive environment, (2) a drama-based healthy lifestyles week, (3) one-to-one goal setting and (4) reinforcement activities.Main outcome measuresThe primary outcome measure was body mass i...
Background Attention deficit hyperactivity disorder was previously seen as a childhood developmen... more Background Attention deficit hyperactivity disorder was previously seen as a childhood developmental disorder, so adult mental health services were not set up to support attention deficit hyperactivity disorder patients who became too old for child services. To our knowledge, this is the first in-depth study of the transition of attention deficit hyperactivity disorder patients from child to adult health services in the UK. Objectives Our objectives were to explore how many young people with attention deficit hyperactivity disorder are in need of services as an adult, what adult attention deficit hyperactivity disorder services are available and how attention deficit hyperactivity disorder stakeholders experience transition from child to adult services. Design An interactive mixed-method design was adopted with three study streams: (1) a 12-month surveillance study with 9-month follow-up to find out how many young people required ongoing medication when they were too old for child s...
Objectives-To estimate the prevalence of bullying in primary school children and to examine its a... more Objectives-To estimate the prevalence of bullying in primary school children and to examine its association with common symptoms in childhood. Design-Semistructured health interview conducted by school nurses as part of a school medical. Setting-Newham, east London. Subjects-Al children in year 4 of school during the academic year 1992-93. Main outcome measures-Reported bullying and common health symptoms. Results-2962 children (93.1% of those on the school roll) were interviewed (ages 7.6 to 10.0 years). Information about bullying was not recorded for 114 children. 22.4% (95% confidence interval 20.9 to 24.0) of children for whom information was available reported that they had been bullied. There was an association between children reporting being bullied sometimes or more often and reporting not sleeping well (odds ratio 3.6, 2.5 to 5.2), bed wetting (1.7, 1.3 to 2.4), feeling sad (3.6, 1.9 to 6.8), and experiencing more than occasional headaches (2.4, 1.8 to 3.4) and tummy aches (2.4, 1.8 to 3.3). A significant trend for increasing risk of symptoms with increased frequency of bullying was shown for all reported health symptoms (P<0.001). Conclusions-Health professionals seeing primary schoolchildren who present with headaches, tummy ache, feeling sad or very sad, bed wetting, and sleeping difficulties should consider bullying as a possible contributory factor.
The version presented here may differ from the published version. If citing, you are advised to c... more The version presented here may differ from the published version. If citing, you are advised to consult the published version for pagination, volume/issue and date of publication RESEARCH Supplementation with antioxidants and folinic acid for children with Down's syndrome: randomised controlled trial Jill M Ellis, training fellow in evidence-based community child health, 1 Hooi Kuan Tan, data manager, 1 Ruth E Gilbert, professor of clinical epidemiology, 1 David P R Muller, professor of biochemistry, 2 William Henley, senior lecturer in statistics, 3 Robert Moy, senior lecturer in community child health, 4 Rachel Pumphrey, research assistant, 4 Cornelius Ani, specialist registrar and honorary lecturer, 5 Sarah Davies, research assistant, 1 Vanessa Edwards, research fellow, 6 Heather Green, research assistant, 2 Alison Salt, consultant developmental paediatrician, 1 Stuart Logan, professor of paediatric epidemiology 6 ABSTRACT Objectives To assess whether supplementation with antioxidants, folinic acid, or both improves the psychomotor and language development of children with Down's syndrome. Design Randomised controlled trial with two by two factorial design. Setting Children living in the Midlands, Greater London, and the south west of England. Participants 156 infants aged under 7 months with trisomy 21. Intervention Daily oral supplementation with antioxidants (selenium 10 μg, zinc 5 mg, vitamin A 0.9 mg, vitamin E 100 mg, and vitamin C 50 mg), folinic acid (0.1 mg), antioxidants and folinic acid combined, or placebo. Main outcome measures Griffiths developmental quotient and an adapted MacArthur communicative development inventory 18 months after starting supplementation; biochemical markers in blood and urine at age 12 months. Results Children randomised to antioxidant supplements attained similar developmental outcomes to those without antioxidants (mean Griffiths developmental quotient 57.3 v 56.1; adjusted mean difference 1.2 points, 95% confidence interval −2.2 to 4.6). Comparison of children randomised to folinic acid supplements or no folinic acid also showed no significant differences in Griffiths developmental quotient (mean 57.6 v 55.9; adjusted mean difference 1.7, −1.7 to 5.1). No between group differences were seen in the mean numbers of words said or signed: for antioxidants versus none the ratio of means was 0.85 (95% confidence interval 0.6 to 1.2), and for folinic acid versus none it was 1.24 (0.87 to 1.77). No significant differences were found between any of the groups in the biochemical outcomes measured. Adjustment for potential confounders did not appreciably change the results. Conclusions This study provides no evidence to support the use of antioxidant or folinic acid supplements in children with Down's syndrome. Trial registration Clinical trials NCT00378456.
A survey of clinical trials of antibiotic prophvlaxis in colon surgery: evidence against further ... more A survey of clinical trials of antibiotic prophvlaxis in colon surgery: evidence against further use of no-treatment controls. N EnglJ Med 1981;305:795-9. 11 Scherer RW, Dickersin K, Kaplan E. The accessible biomedical literature represents a fraction of all studies in a field. Paper presented at the workshop for editors of refereed scientific journals, Nashville, Tennessee, March 1992.
Objective To compare the effects, safety, and cost effectiveness of antenatal screening strategie... more Objective To compare the effects, safety, and cost effectiveness of antenatal screening strategies for Down's syndrome. Design Analysis of incremental cost effectiveness. Setting United Kingdom. Main outcome measures Number of liveborn babies with Down's syndrome, miscarriages due to chorionic villus sampling or amniocentesis, healthcare costs of screening programme, and additional costs and additional miscarriages per additional affected live birth prevented by adopting a more effective strategy. Results Compared with no screening, the additional cost per additional liveborn baby with Down's syndrome prevented was £22 000 for measurement of nuchal translucency. The cost of the integrated test was £51 000 compared with measurement of nuchal translucency. All other strategies were more costly and less effective, or cost more per additional affected baby prevented. Depending on the cost of the screening test, the first trimester combined test and the quadruple test would also be cost effective options. Conclusions The choice of screening strategy should be between the integrated test, first trimester combined test, quadruple test, or nuchal translucency measurement depending on how much service providers are willing to pay, the total budget available, and values on safety. Screening based on maternal age, the second trimester double test, and the first trimester serum test was less effective, less safe, and more costly than these four options.
Background: The workplace is an ideal setting for health promotion. Helping employees to be more ... more Background: The workplace is an ideal setting for health promotion. Helping employees to be more physically active can not only improve their physical and mental health, but can also have economic benefits such as reduced sickness absence. The current paper describes the development of a three month theory-based intervention that aims to increase levels of moderate intensity physical activity amongst employees in sedentary occupations. Methods: The intervention was developed using an intervention mapping protocol. The intervention was also informed by previous literature, qualitative focus groups, an expert steering group, and feedback from key contacts within a range of organisations. Results: The intervention was designed to target awareness (e.g. provision of information), motivation (e.g. goal setting, social support) and environment (e.g. management support) and to address behavioural (e.g. increasing moderate physical activity in work) and interpersonal outcomes (e.g. encourage colleagues to be more physically active). The intervention can be implemented by local facilitators without the requirement for a large investment of resources. A facilitator manual was developed which listed step by step instructions on how to implement each component along with a suggested timetable. Conclusion: Although time consuming, intervention mapping was found to be a useful tool for developing a theory based intervention. The length of this process has implications for the way in which funding bodies allow for the development of interventions as part of their funding policy. The intervention will be evaluated in a cluster randomised trial involving 1350 employees from 5 different organisations, results available September 2009.
Omission of relevant covariates can lead to bias when estimating treatment or exposure effects fr... more Omission of relevant covariates can lead to bias when estimating treatment or exposure effects from survival data in both randomized controlled trials and observational studies. This paper presents a general approach to assessing bias when covariates are omitted from the Cox model. The proposed method is applicable to both randomized and non-randomized studies. We distinguish between the effects of three possible sources of bias: omission of a balanced covariate, data censoring and unmeasured confounding. Asymptotic formulae for determining the bias are derived from the large sample properties of the maximum likelihood estimator. A simulation study is used to demonstrate the validity of the bias formulae and to characterize the influence of the different sources of bias. It is shown that the bias converges to fixed limits as the effect of the omitted covariate increases, irrespective of the degree of confounding. The bias formulae are used as the basis for developing a new method of sensitivity analysis to assess the impact of omitted covariates on estimates of treatment or exposure effects. In simulation studies, the proposed method gave unbiased treatment estimates and confidence intervals with good coverage when the true sensitivity parameters were known. We describe application of the method to a randomized controlled trial and a non-randomized study.
Archives of Pediatrics & Adolescent Medicine, 2002
Objective: To determine the effect of levothyroxine sodium starting dose on cognitive development... more Objective: To determine the effect of levothyroxine sodium starting dose on cognitive development, growth, or behavior in children with congenital hypothyroidism identified by neonatal screening. Design: Systematic review of cohort studies. Two analyses were performed: a between-study comparison of mean starting dose with mean developmental score and an analysis of the within-study effects of starting dose on cognitive development, growth, or behavior. Results: The between-study comparison (14 cohort studies based on 1321 patients) found that the standardized mean IQ or developmental quotient scores ranged from 90 to 115 but were not associated with the mean starting dose of levothyroxine (P=.48). The within-study com
BackgroundChildren and young people with neurodisability often need help to achieve socially acce... more BackgroundChildren and young people with neurodisability often need help to achieve socially acceptable bladder and bowel control. Approaches vary depending on whether or not the impairment results from spinal cord pathology that impairs motor control and sensation of the bladder and bowel. Currently, there is uncertainty about which interventions are effective.ObjectiveThe objective was to summarise the available evidence on and current practice for improving continence in children and young people with neurodisability.DesignA systematic review of the effectiveness, cost-effectiveness and factors that modify intervention implementation, alongside a cross-sectional, online survey of current practice with health professionals, parent carers, school and care staff and young people with neurodisability.ResultsTwelve databases were searched in the review, resulting in 5756 references; 71 studies (72 papers) were included in the analyses. Most of the evidence was for children with spinal...
ObjectivesParent carers of children with special educational needs or disability are at risk of p... more ObjectivesParent carers of children with special educational needs or disability are at risk of poorer mental and physical health. In response to these needs, we codeveloped the ‘Healthy Parent Carers’ (HPC) programme. This study examined the views and experiences of participants in the HPC feasibility trial to inform programme refinement.Intervention, setting and participantsHPC is a peer-led group-based intervention (supported by online materials) for primary carers of disabled children, encouraging behaviours linked with health and well-being. It was delivered by two lead and six assistant peer facilitators in six community sites (one lead and one assistant per group) in South West England over six or 12 sessions. Control participants had online materials only. The trial involved 47 intervention and 45 control parent carers (97% female and 97% white) and eight facilitators (one male).DesignA preplanned mixed methods process evaluation using questionnaires and checklists (during a...
BackgroundApproximately one-third of children in England leave primary school overweight or obese... more BackgroundApproximately one-third of children in England leave primary school overweight or obese. There is little evidence of effective obesity prevention programmes for children in this age group.ObjectiveTo determine the effectiveness and cost-effectiveness of a school-based healthy lifestyles programme in preventing obesity in children aged 9–10 years.DesignA cluster randomised controlled trial with an economic and process evaluation.SettingThirty-two primary schools in south-west England.ParticipantsChildren in Year 5 (aged 9–10 years) at recruitment and in Year 7 (aged 11–12 years) at 24 months’ post-baseline follow-up.InterventionThe Healthy Lifestyles Programme (HeLP) ran during the spring and summer terms of Year 5 into the autumn term of Year 6 and included four phases: (1) building a receptive environment, (2) a drama-based healthy lifestyles week, (3) one-to-one goal setting and (4) reinforcement activities.Main outcome measuresThe primary outcome measure was body mass i...
Background Attention deficit hyperactivity disorder was previously seen as a childhood developmen... more Background Attention deficit hyperactivity disorder was previously seen as a childhood developmental disorder, so adult mental health services were not set up to support attention deficit hyperactivity disorder patients who became too old for child services. To our knowledge, this is the first in-depth study of the transition of attention deficit hyperactivity disorder patients from child to adult health services in the UK. Objectives Our objectives were to explore how many young people with attention deficit hyperactivity disorder are in need of services as an adult, what adult attention deficit hyperactivity disorder services are available and how attention deficit hyperactivity disorder stakeholders experience transition from child to adult services. Design An interactive mixed-method design was adopted with three study streams: (1) a 12-month surveillance study with 9-month follow-up to find out how many young people required ongoing medication when they were too old for child s...
Objectives-To estimate the prevalence of bullying in primary school children and to examine its a... more Objectives-To estimate the prevalence of bullying in primary school children and to examine its association with common symptoms in childhood. Design-Semistructured health interview conducted by school nurses as part of a school medical. Setting-Newham, east London. Subjects-Al children in year 4 of school during the academic year 1992-93. Main outcome measures-Reported bullying and common health symptoms. Results-2962 children (93.1% of those on the school roll) were interviewed (ages 7.6 to 10.0 years). Information about bullying was not recorded for 114 children. 22.4% (95% confidence interval 20.9 to 24.0) of children for whom information was available reported that they had been bullied. There was an association between children reporting being bullied sometimes or more often and reporting not sleeping well (odds ratio 3.6, 2.5 to 5.2), bed wetting (1.7, 1.3 to 2.4), feeling sad (3.6, 1.9 to 6.8), and experiencing more than occasional headaches (2.4, 1.8 to 3.4) and tummy aches (2.4, 1.8 to 3.3). A significant trend for increasing risk of symptoms with increased frequency of bullying was shown for all reported health symptoms (P<0.001). Conclusions-Health professionals seeing primary schoolchildren who present with headaches, tummy ache, feeling sad or very sad, bed wetting, and sleeping difficulties should consider bullying as a possible contributory factor.
The version presented here may differ from the published version. If citing, you are advised to c... more The version presented here may differ from the published version. If citing, you are advised to consult the published version for pagination, volume/issue and date of publication RESEARCH Supplementation with antioxidants and folinic acid for children with Down's syndrome: randomised controlled trial Jill M Ellis, training fellow in evidence-based community child health, 1 Hooi Kuan Tan, data manager, 1 Ruth E Gilbert, professor of clinical epidemiology, 1 David P R Muller, professor of biochemistry, 2 William Henley, senior lecturer in statistics, 3 Robert Moy, senior lecturer in community child health, 4 Rachel Pumphrey, research assistant, 4 Cornelius Ani, specialist registrar and honorary lecturer, 5 Sarah Davies, research assistant, 1 Vanessa Edwards, research fellow, 6 Heather Green, research assistant, 2 Alison Salt, consultant developmental paediatrician, 1 Stuart Logan, professor of paediatric epidemiology 6 ABSTRACT Objectives To assess whether supplementation with antioxidants, folinic acid, or both improves the psychomotor and language development of children with Down's syndrome. Design Randomised controlled trial with two by two factorial design. Setting Children living in the Midlands, Greater London, and the south west of England. Participants 156 infants aged under 7 months with trisomy 21. Intervention Daily oral supplementation with antioxidants (selenium 10 μg, zinc 5 mg, vitamin A 0.9 mg, vitamin E 100 mg, and vitamin C 50 mg), folinic acid (0.1 mg), antioxidants and folinic acid combined, or placebo. Main outcome measures Griffiths developmental quotient and an adapted MacArthur communicative development inventory 18 months after starting supplementation; biochemical markers in blood and urine at age 12 months. Results Children randomised to antioxidant supplements attained similar developmental outcomes to those without antioxidants (mean Griffiths developmental quotient 57.3 v 56.1; adjusted mean difference 1.2 points, 95% confidence interval −2.2 to 4.6). Comparison of children randomised to folinic acid supplements or no folinic acid also showed no significant differences in Griffiths developmental quotient (mean 57.6 v 55.9; adjusted mean difference 1.7, −1.7 to 5.1). No between group differences were seen in the mean numbers of words said or signed: for antioxidants versus none the ratio of means was 0.85 (95% confidence interval 0.6 to 1.2), and for folinic acid versus none it was 1.24 (0.87 to 1.77). No significant differences were found between any of the groups in the biochemical outcomes measured. Adjustment for potential confounders did not appreciably change the results. Conclusions This study provides no evidence to support the use of antioxidant or folinic acid supplements in children with Down's syndrome. Trial registration Clinical trials NCT00378456.
A survey of clinical trials of antibiotic prophvlaxis in colon surgery: evidence against further ... more A survey of clinical trials of antibiotic prophvlaxis in colon surgery: evidence against further use of no-treatment controls. N EnglJ Med 1981;305:795-9. 11 Scherer RW, Dickersin K, Kaplan E. The accessible biomedical literature represents a fraction of all studies in a field. Paper presented at the workshop for editors of refereed scientific journals, Nashville, Tennessee, March 1992.
Objective To compare the effects, safety, and cost effectiveness of antenatal screening strategie... more Objective To compare the effects, safety, and cost effectiveness of antenatal screening strategies for Down's syndrome. Design Analysis of incremental cost effectiveness. Setting United Kingdom. Main outcome measures Number of liveborn babies with Down's syndrome, miscarriages due to chorionic villus sampling or amniocentesis, healthcare costs of screening programme, and additional costs and additional miscarriages per additional affected live birth prevented by adopting a more effective strategy. Results Compared with no screening, the additional cost per additional liveborn baby with Down's syndrome prevented was £22 000 for measurement of nuchal translucency. The cost of the integrated test was £51 000 compared with measurement of nuchal translucency. All other strategies were more costly and less effective, or cost more per additional affected baby prevented. Depending on the cost of the screening test, the first trimester combined test and the quadruple test would also be cost effective options. Conclusions The choice of screening strategy should be between the integrated test, first trimester combined test, quadruple test, or nuchal translucency measurement depending on how much service providers are willing to pay, the total budget available, and values on safety. Screening based on maternal age, the second trimester double test, and the first trimester serum test was less effective, less safe, and more costly than these four options.
Background: The workplace is an ideal setting for health promotion. Helping employees to be more ... more Background: The workplace is an ideal setting for health promotion. Helping employees to be more physically active can not only improve their physical and mental health, but can also have economic benefits such as reduced sickness absence. The current paper describes the development of a three month theory-based intervention that aims to increase levels of moderate intensity physical activity amongst employees in sedentary occupations. Methods: The intervention was developed using an intervention mapping protocol. The intervention was also informed by previous literature, qualitative focus groups, an expert steering group, and feedback from key contacts within a range of organisations. Results: The intervention was designed to target awareness (e.g. provision of information), motivation (e.g. goal setting, social support) and environment (e.g. management support) and to address behavioural (e.g. increasing moderate physical activity in work) and interpersonal outcomes (e.g. encourage colleagues to be more physically active). The intervention can be implemented by local facilitators without the requirement for a large investment of resources. A facilitator manual was developed which listed step by step instructions on how to implement each component along with a suggested timetable. Conclusion: Although time consuming, intervention mapping was found to be a useful tool for developing a theory based intervention. The length of this process has implications for the way in which funding bodies allow for the development of interventions as part of their funding policy. The intervention will be evaluated in a cluster randomised trial involving 1350 employees from 5 different organisations, results available September 2009.
Omission of relevant covariates can lead to bias when estimating treatment or exposure effects fr... more Omission of relevant covariates can lead to bias when estimating treatment or exposure effects from survival data in both randomized controlled trials and observational studies. This paper presents a general approach to assessing bias when covariates are omitted from the Cox model. The proposed method is applicable to both randomized and non-randomized studies. We distinguish between the effects of three possible sources of bias: omission of a balanced covariate, data censoring and unmeasured confounding. Asymptotic formulae for determining the bias are derived from the large sample properties of the maximum likelihood estimator. A simulation study is used to demonstrate the validity of the bias formulae and to characterize the influence of the different sources of bias. It is shown that the bias converges to fixed limits as the effect of the omitted covariate increases, irrespective of the degree of confounding. The bias formulae are used as the basis for developing a new method of sensitivity analysis to assess the impact of omitted covariates on estimates of treatment or exposure effects. In simulation studies, the proposed method gave unbiased treatment estimates and confidence intervals with good coverage when the true sensitivity parameters were known. We describe application of the method to a randomized controlled trial and a non-randomized study.
Archives of Pediatrics & Adolescent Medicine, 2002
Objective: To determine the effect of levothyroxine sodium starting dose on cognitive development... more Objective: To determine the effect of levothyroxine sodium starting dose on cognitive development, growth, or behavior in children with congenital hypothyroidism identified by neonatal screening. Design: Systematic review of cohort studies. Two analyses were performed: a between-study comparison of mean starting dose with mean developmental score and an analysis of the within-study effects of starting dose on cognitive development, growth, or behavior. Results: The between-study comparison (14 cohort studies based on 1321 patients) found that the standardized mean IQ or developmental quotient scores ranged from 90 to 115 but were not associated with the mean starting dose of levothyroxine (P=.48). The within-study com
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Papers by Stuart Logan