GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction.

Alonso-Coello P Schünemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Rada G, Rosenbaum S, Morelli A, Guyatt GH, Oxman AD; GRADE Working Group.

Summary points
-Clinicians, guideline developers, and policymakers sometimes neglect important criteria, give undue weight to criteria, and do not use the best available evidence to inform their judgments
-Explicit and transparent systems for decision making can help to ensure that all important criteria are considered and that decisions are informed by the best available research evidence
-The purpose of Evidence to Decision (EtD) frameworks is to help people use evidence in a structured and transparent way to inform decisions in the context of clinical recommendations, coverage decisions, and health system or public health recommendations and decisions
-EtD frameworks have a common structure that includes formulation of the question, an assessment of the evidence, and drawing conclusions, though there are some differences between frameworks for each type of decision
-EtD frameworks inform users about the judgments that were made and the evidence supporting those judgments by making the basis for decisions transparent to target audiences
-EtD frameworks also facilitate dissemination of recommendations and enable decision makers in other jurisdictions to adopt recommendations or decisions, or adapt them to their context


Swaddling and the Risk of Sudden Infant Death Syndrome: A Meta-analysis.

Pease AS, Fleming PJ, Hauck FR, Moon RY, Horne RS, L'Hoir MP, Ponsonby AL, Blair PS.
Pediatrics. 2016 Jun;137(6). pii: e20153275. doi: 10.1542/peds.2015-3275. Epub

CONTEXT: Swaddling is a traditional practice of wrapping infants to promote calming and sleep. Although the benefits and risks of swaddling in general have been studied, the practice in relation to sudden infant death syndrome remains unclear.
OBJECTIVE: The goal of this study was to conduct an individual-level meta-analysis of sudden infant death syndrome risk for infants swaddled for sleep.
DATA SOURCES: Additional data on sleeping position and age were provided by authors of included studies.
STUDY SELECTION: Observational studies that measured swaddling for the last or reference sleep were included.
DATA EXTRACTION: Of 283 articles screened, 4 studies met the inclusion criteria.
RESULTS: There was significant heterogeneity among studies (I(2) = 65.5%; P = .03), and a random effects model was therefore used for analysis. The overall age-adjusted pooled odds ratio (OR) for swaddling in all 4 studies was 1.58 (95%  confidence interval [CI], 0.97-2.58). Removing the most recent study conducted in the United Kingdom reduced the heterogeneity (I(2) = 28.2%; P = .25) and provided a pooled OR (using a fixed effects model) of 1.38 (95% CI, 1.05-1.80). Swaddling  risk varied according to position placed for sleep; the risk was highest for prone sleeping (OR, 12.99 [95% CI, 4.14-40.77]), followed by side sleeping (OR, 3.16 [95% CI, 2.08-4.81]) and supine sleeping (OR, 1.93 [95% CI, 1.27-2.93]).
Limited evidence suggested swaddling risk increased with infant age and was associated with a twofold risk for infants aged >6 months.
LIMITATIONS: Heterogeneity among the few studies available, imprecise definitions of swaddling, and difficulties controlling for further known risks make interpretation difficult.
CONCLUSIONS: Current advice to avoid front or side positions for sleep especially applies to infants who are swaddled. Consideration should be given to an age after which swaddling should be discouraged.


Primary Care Interventions to Support Breastfeeding: An Updated Systematic Review for the U.S. Preventive Services Task Force.

Agency for Healthcare Research and Quality U.S. Department of Health and Human Services.
Evidence Synthesis Number 143 . AHRQ Publication No. 15-05218-EF-1April 2016.

Objective: We conducted this systematic review to support the U.S. Preventive Services Task Force in updating its 2009 recommendation on counseling for breastfeeding. Our review addressed three questions: 1) What are the effects of prenatal, peripartum, and postpartum individual-and health care system-level interventions to promote and support breastfeeding on child and maternal health outcomes? 2) What are the effects of interventions on the initiation, duration, and exclusivity of breastfeeding? 3) Are there adverse events associated with interventions to promote and support breastfeeding?
Data Sources: We performed a search of MEDLINE, PubMed Publisher-Supplied, Cumulative Index for Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, and PsycInfo for studies published between January 1, 2008, and September 25, 2015. Studies included in the original U.S. Preventive Services Task Force review were re-evaluated. We supplemented searches by examining bibliographies from retrieved articles and consulting outside experts. We searched federal and international trial registries for ongoing trials.
Study Selection: Two researchers reviewed 2769 abstracts and 211 articles against the pre-specified inclusion criteria. Eligible studies included English-language studies conducted in a developed country that evaluated the effectiveness of an individual-or system-level breastfeeding intervention among pregnant women or mothers of full-or near-term infants. We included randomized or cluster randomized controlled trials for individual-level interventions and controlled before-and-after or prospective cohort studies for health system or policy interventions that reported health or breastfeeding outcomes. We conducted dual, independent critical appraisal of all provisionally included studies and abstracted all important study details and results from fair-and good-quality studies. Data were independently abstracted by one reviewer and confirmed by another.
Data Analysis: We qualitatively synthesized the results for health outcomes and adverse events. For breastfeeding outcomes, we synthesized the results by population (adults separately from adolescents or young adults) and intervention focus (individual-versus system-level approaches). Because of the small number of system-level interventions, we report those results narratively and do not pool the data. For individual-level interventions, we conducted random effects meta-analyses using the DerSimonian and Laird method and calculated pooled risk ratios for breastfeeding initiation and for any or exclusive breastfeeding at postpartum time points less than 3 months, 3 to 6 months, and 6 months. We explored potential effect modification by various population and intervention characteristics, such as intention to breastfeed and intervention type, and timing through stratified analyses and meta-regression. We generated funnel plots and conducted tests for small-study effects for all pooled analyses.
Results: We included 52 studies that were reported in 57 publications. The included studies were highly variable in terms of the country, study population, intervention and control conditions, specific outcome measures, and timing of measurements.
 on a range of infant health outcomes, such as gastrointestinal illness, otitis media, respiratory tract illness, and healthcare use. None of the studies reported maternal health outcomes.
Breastfeeding Outcomes. On the basis of 43 trials, breastfeeding support and education interventions targeting individuals were associated with a statistically significant higher likelihood of any and exclusive breastfeeding at less than 3 months and at 3 to 6 months compared with usual care among adults. Pooled estimates indicated beneficial associations for any breastfeeding at less than 3 months (risk ratio [RR], 1.07 [95% confidence interval {CI}, 1.03 to 1.11]; k=26) and at 3 to 6 months (RR, 1.11 [95% CI, 1.04 to 1.18]; k=23) and for exclusive breastfeeding at less than 3 months (RR, 1.21 [95% CI, 1.11 to 1.33]; k=22) and at 3 to 6 months (RR, 1.20 [95% CI, 1.05 to 1.38]; k=18). At 6 months, individual-level interventions with adults were associated with a 16 percent higher likelihood of exclusive breastfeeding (RR, 1.16 [95% CI, 1.02 to 1.32]; k=17) but not with any breastfeeding. The association between individual-level interventions and breastfeeding initiation was not statistically significant based on the pooled point estimate, but the confidence interval did not rule out potential benefit (RR, 1.00 [95% CI, 0.99 to 1.02]; k=14). There was some suggestion that interventions that took place during a combination of prenatal, peripartum, or postpartum time periods were more effective than those that took place only during one time period. There was no indication of effect modification by other intervention characteristics or by population subgroups. All four trials of individual-level interventions among adolescents or young adults reported higher rates of breastfeeding among intervention versus control group participants. For system-level interventions, there was limited, mixed evidence of an effect on rates of breastfeeding initiation or the duration of any or exclusive breastfeeding from well-controlled studies.
Adverse Events. Two trials among adults reported on adverse events related to a breastfeeding support intervention. One trial found no significant differences between groups in maternal anxiety at 2 weeks. The other reported that a few mothers expressed feelings of anxiety and decreased confidence in their breastfeeding abilities despite breastfeeding going well and therefore discontinued their participation in the peer counseling intervention.
Limitations: There were a number of threats to internal validity within the included studies. Detail regarding the measurement of breastfeeding outcomes, sociodemographic and breastfeeding-related population characteristics, and intervention and usual care characteristics were lacking. Our pooled analyses relied on unadjusted breastfeeding rates and did not control for potential confounding.
Conclusions: The body of fair-to-good quality evidence related to primary care interventions to support breastfeeding has nearly doubled since the release of the 2009 U.S. Preventive Services Task Force review and recommendation. The updated evidence confirms that breastfeeding support and education provided by professionals and peers to individual women, regardless of the mother’s age, is associated with an increase in the duration of any and exclusive breastfeeding. There are limited well-controlled studies examining the effectiveness of system-level policies and practices.


Screening for Celiac Disease: A Systematic Review for the U.S. Preventive Services Task Force Agency for Healthcare Research and Quality U.S. Department of Health and Human Services

Agency for Healthcare Research and Quality U.S. Department of Health and Human Services.
Evidence Synthesis Number 144. AHRQ Publication No. 14-05215-EF-1. May 2016.

Background: Unrecognized celiac disease (CD) may have adverse effects on morbidity and mortality. Purpose: To review the evidence on screening for CD in asymptomatic adults, adolescents, and children 3 years of age and older for the United States Preventive Services Task Force.
Data Sources: Ovid MEDLINE, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews (to February 2016).
Study Selection: Randomized clinical trials, cohort studies, and case-control studies of screening versus no screening, one screening strategy versus another, treatment versus no treatment, or immediate versus delayed treatment that evaluated clinical outcomes; and studies on diagnostic accuracy of serological tests for CD.
Data Extraction: One investigator abstracted data, a second checked data for accuracy, and two investigators independently assessed study quality using predefined criteria. Data Synthesis (Results): We identified no trials of screening for CD. One recent, good-quality systematic review found serological tests to be accurate for diagnosing CD, but two studies conducted in asymptomatic populations reported lower sensitivity than in studies not restricted to asymptomatic populations. One fair-quality, small (n=40), Finnish treatment trial of screendetected, asymptomatic adults with positive serological findings found initiation of a gluten-free diet associated with small improvement in gastrointestinal symptoms versus no gluten-free diet (less than 1 point on a 1 to 7 scale) at 1 year, with no differences on most measures of quality of life. No withdrawals due to adverse events occurred during the trial.
Limitations: Limited or no evidence for all key questions; limited to English language studies. Conclusions: More research is needed to understand the effectiveness of screening and treatment for CD in asymptomatic adults, adolescents, and children; accuracy of screening tests; and optimal screening strategies.


La detección precoz de Trastornos del Espectro Autista (TEA). El programa de cribado con M-CHAT en España y revisión de otros programas en Europa.

García Primo, P.

Los Trastornos del Espectro Autista (TEA) constituyen un conjunto de alteraciones graves del desarrollo neurológico que se caracterizan por la coocurrencia de dificultades en la interacción social y en la comunicación y por patrones restringidos y repetitivos de comportamiento, siendo una de las discapacidades del desarrollo más frecuentes en la infancia temprana.
El trabajo aquí presentado es una compilación de cuatro publicaciones (un capítulo de libro en español y 3 artículos, 2 de ellos publicados en revistas científicas internacionales en inglés y un artículo en español, publicado en una revista española). Todas y cada una de estas publicaciones están dirigidas, al avance del conocimiento y la puesta en práctica de de estrategias de cribado de TEA en edades tempranas, con el propósito de repercutir positivamente en el pronóstico de estos niños y en el mejor ajuste y calidad de vida de ellos y de sus familias. Los objetivos específicos  fueron alcanzados a través de cada uno de los estudios que forman parte de esta tesis y que son: 1) Desarrollar el proceso de traducción, adaptación cultural, análisis de validez y fiabilidad del cuestionario M-CHAT en España, 2) Pilotar y evaluar el funcionamiento y la estructura de un  programa de cribado con la versión validada en español del M-CHAT  a todos sus niveles (viabilidad, costes, nivel de participación...) dentro del Sistema Público de Salud en España y 3) Revisar y analizar de forma comparativa los diferentes procedimientos  utilizados en los estudios de cribado de autismo en Europa y describir su situación actual, así como identificar los posibles factores y aspectos metodológicos que se necesitan tener en cuenta para la interpretación de resultados en los estudios de cribado del autismo.  Se espera que los resultados de esta tesis sean especialmente útiles en lugares donde todavía no se ha puesto en marcha ningún programa de detección precoz del autismo, facilitando la toma de decisiones sobre qué herramienta puede funcionar mejor según las características del contexto.

Screening for Autism Spectrum Disorder in Young Children: A Systematic Evidence Review for the U.S. Preventive Services Task Force.

McPheeters M, PhD,Weitlauf A,  Vehorn A,  Taylor C,  Sathe NA,  Shanthi Krishnaswami M, Fonnesbeck C,  Warren ZE.
AHRQ Publication No. 13-05185-EF-1 February 2016

Context: The Centers for Disease Control and Prevention estimates that 1 in 68 children has an autism spectrum disorder (ASD) and the majority of children are not diagnosed until after 4 years of age. Current approaches rely on developmental surveillance, general developmental screening, and/or parental concerns. Systematic screening has been advocated for identifying ASD at earlier ages.

Objective: We systematically reviewed the evidence about benefits and harms of routine screening for ASD in primary care settings.
Methods: We explicitly focused on studies of screening instruments for use in young (≤36 months of age), unselected populations (e.g., universal screening approaches).

Results: We identified 17 unique screening studies reported in 22 papers. The most commonly studied tool was the Modified Checklist for Autism in Toddlers (M-CHAT), including the most recently available variant (M-CHAT-Revised with Followup [M-CHAT-R/F]), which has a positive predictive value of 48 percent in diverse populations of children ages 16 to 30 months. Forty-two studies of good and fair quality addressed interventions for young children. Among these, 17 involved direct provision of intervention to children. Fifteen of these 17 studies assessed cognitive outcomes, and outcomes were significantly more improved in the treatment versus comparison arm in 10 studies. Sixteen of these 17 studies assessed language outcomes, and outcomes were significantly improved in the treatment versus comparison group in 10 studies. Thirteen studies involved parent training. Five of these 13 studies addressed cognitive outcomes, and outcomes were significantly improved in the treatment versus comparison group in one study. Twelve of the 13 studies addressed language outcomes, and outcomes were significantly improved in the treatment versus comparison group in three studies. Thus, 20 studies overall measured cognitive outcomes and 11 reported greater benefit for the intervention group compared to the control group, and language outcomes were significantly improved in treatment versus comparison arms in 13 of 28 studies assessing language. Twelve studies focused on play and interaction and typically measured joint attention as the outcome. Nine out of 10 studies evaluating joint attention outcomes reported greater benefit in the treatment arm compared to the control arm. None of the studies focused on screen-detected children.

Conclusions: Both the M-CHAT and the M-CHAT-R/F, when including the followup interview procedure, have a positive predictive value of around 50 percent in community practices for children between 16 and 30 months of age. Screening tools are widely available. Multiple treatments are available to young children with ASD. Early intensive interventions demonstrate statistically significant improvements in cognitive and language outcomes in children compared to eclectic treatments obtained in the community or other comparison groups, although the studies are generally small, and, within the studies, some children benefit while others do not. We found no studies that directly compared long-term outcomes of screened versus non screened children. More research is needed to determine the benefits and harms of screening the general population.


Improving Child Oral Health: Cost Analysis of a National Nursery Toothbrushing Programme

Anopa Y, McMahon AD, Conway DI, Ball GE, McIntosh E, Macpherson LM.
PLoS One. 2015 Aug 25;10(8):e0136211. doi: 10.1371/journal.pone.0136211. eCollection 2015.

Dental caries is one of the most common diseases of childhood. The aim of this study was to compare the cost of providing the Scotland-wide nursery toothbrushing programme with associated National Health Service (NHS) cost savings from improvements in the dental health of five-year-old children: through avoided dental extractions, fillings and potential treatments for decay.
Estimated costs of the nursery toothbrushing programme in 2011/12 were requested from all Scottish Health Boards. Unit costs of a filled, extracted and decayed primary tooth were calculated using verifiable sources of information. Total costs associated with dental treatments were estimated for the period from 1999/00 to 2009/10. These costs were based on the unit costs above and using the data of the National Dental Inspection Programme and then extrapolated to the population level. Expected cost savings were calculated for each of the subsequent years in comparison with the 2001/02 dental treatment costs. Population standardised analysis of hypothetical cohorts of 1000 children per deprivation category was performed.
The estimated cost of the nursery toothbrushing programme in Scotland was £1,762,621 per year. The estimated cost of dental treatments in the baseline year 2001/02 was £8,766,297, while in 2009/10 it was £4,035,200. In 2002/03 the costs of dental treatments increased by £213,380 (2.4%). In the following years the costs decreased dramatically with the estimated annual savings ranging from £1,217,255 in 2003/04 (13.9% of costs in 2001/02) to £4,731,097 in 2009/10 (54.0%). Population standardised analysis by deprivation groups showed that the largest decrease in modelled costs was for the most deprived cohort of children.
The NHS costs associated with the dental treatments for five-year-old children decreased over time. In the eighth year of the toothbrushing programme the expected savings were more than two and a half times the costs of the programme implementation.

Expert commentary:
Inequalities in oral health remain a significant public health challenge and the management of tooth decay imposes a substantial cost burden to the National Health Service. Getting teeth into contact with fluoride is a key preventive measure. In the absence of water fluoridation, school-based toothbrushing programmes have been shown to be effective in reducing decay, and are recommended in recent NICE guidance to local authorities. The work reported here suggests that such programmes are effective in terms of NHS dental treatment costs avoided, and particularly so in the most disadvantaged communities. Of course what this paper doesn’t account for is the avoided pain and suffering associated with dental decay in young children. This work supports the need for local authorities in England to consider such schemes.

Professor Ivor Chestnutt, Professor of Dental Public Health, Cardiff University


Diet, physical activity, and behavioural interventions for the treatment of overweight or obesity in preschool children up to the age of 6 years

Colquitt J, Loveman E, O'Malley C, Azevedo LB, Mead E, Al-Khudairy L, et al.
Cochrane Database Syst Rev. 2016;3:CD012105

BACKGROUND: Child overweight and obesity has increased globally, and can be associated with short- and long-term health consequences.
OBJECTIVES: To assess the effects of diet, physical activity, and behavioural interventions for the treatment of overweight or obesity in preschool children up to the age of 6 years.
SEARCH METHODS: We performed a systematic literature search in the databases Cochrane Library, MEDLINE, EMBASE, PsycINFO, CINAHL, and LILACS, as well as in the trial registers ClinicalTrials.gov and ICTRP Search Portal. We also checked references of identified trials and systematic reviews. We applied no language restrictions. The date of the last search was March 2015 for all databases.
SELECTION CRITERIA: We selected randomised controlled trials (RCTs) of diet, physical activity, and behavioural interventions for treating overweight or obesity in preschool children aged 0 to 6 years.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risk of bias, evaluated the overall quality of the evidence using the GRADE instrument, and extracted data following the Cochrane Handbook for Systematic Reviews of Interventions. We contacted trial authors for additional information.
MAIN RESULTS: We included 7 RCTs with a total of 923 participants: 529 randomised to an intervention and 394 to a comparator. The number of participants per trial ranged from 18 to 475. Six trials were parallel RCTs, and one was a cluster RCT. Two trials were three-arm trials, each comparing two interventions with a control group. The interventions and comparators in the trials varied. We categorised the comparisons into two groups: multicomponent interventions and dietary interventions. The overall quality of the evidence was low or very low, and six trials had a high risk of bias on individual 'Risk of bias' criteria. The children in the included trials were followed up for between six months and three years.In trials comparing a multicomponent intervention with usual care, enhanced usual care, or information control, we found a greater reduction in body mass index (BMI) z score in the intervention groups at the end of the intervention (6 to 12 months): mean difference (MD) -0.3 units (95% confidence interval (CI) -0.4 to -0.2); P < 0.00001; 210 participants; 4 trials; low-quality evidence, at 12 to 18 months' follow-up: MD -0.4 units (95% CI -0.6 to -0.2); P = 0.0001; 202 participants; 4 trials; low-quality evidence, and at 2 years' follow-up: MD -0.3 units (95% CI -0.4 to -0.1); 96 participants; 1 trial; low-quality evidence.One trial stated that no adverse events were reported; the other trials did not report on adverse events. Three trials reported health-related quality of life and found improvements in some, but not all, aspects. Other outcomes, such as behaviour change and parent-child relationship, were inconsistently measured.One three-arm trial of very low-quality evidence comparing two types of diet with control found that both the dairy-rich diet (BMI z score change MD -0.1 units (95% CI -0.11 to -0.09); P < 0.0001; 59 participants) and energy-restricted diet (BMI z score change MD -0.1 units (95% CI -0.11 to -0.09); P < 0.0001; 57 participants) resulted in greater reduction in BMI than the comparator at the end of the intervention period, but only the dairy-rich diet maintained this at 36 months' follow-up (BMI z score change in MD -0.7 units (95% CI -0.71 to -0.69); P < 0.0001; 52 participants). The energy-restricted diet had a worse BMI outcome than control at this follow-up (BMI z score change MD 0.1 units (95% CI 0.09 to 0.11); P < 0.0001; 47 participants). There was no substantial difference in mean daily energy expenditure between groups. Health-related quality of life, adverse effects, participant views, and parenting were not measured.No trial reported on all-cause mortality, morbidity, or socioeconomic effects.All results should be interpreted cautiously due to their low quality and heterogeneous interventions and comparators.
AUTHORS' CONCLUSIONS: Muticomponent interventions appear to be an effective treatment option for overweight or obese preschool children up to the age of 6 years. However, the current evidence is limited, and most trials had a high risk of bias. Most trials did not measure adverse events. We have identified four ongoing trials that we will include in future updates of this review.The role of dietary interventions is more equivocal, with one trial suggesting that dairy interventions may be effective in the longer term, but not energy-restricted diets. This trial also had a high risk of bias.