Symptomatic benefits of testosterone treatment in patient subgroups: a systematic review, individual participant data meta-analysis, and aggregate data meta-analysis.

BACKGROUND: Testosterone replacement therapy is known to improve sexual function in men younger than 40 years with pathological hypogonadism. However, the extent to which testosterone alleviates sexual dysfunction in older men and men with obesity is unclear, despite the fact that testosterone is being increasingly prescribed to these patient populations. We aimed to evaluate whether subgroups of men with low testosterone derive any symptomatic benefit from testosterone treatment. METHODS: We did a systematic review and meta-analysis to evaluate characteristics associated with symptomatic benefit of testosterone treatment versus placebo in men aged 18 years and older with a baseline serum total testosterone concentration of less than 12 nmol/L. We searched major electronic databases (MEDLINE, Embase, Science Citation Index, and the Cochrane Central Register of Controlled Trials) and clinical trial registries for reports published in English between Jan 1, 1992, and Aug 27, 2018. Anonymised individual participant data were requested from the investigators of all identified trials. Primary (cardiovascular) outcomes from this analysis have been published previously. In this report, we present the secondary outcomes of sexual function, quality of life, and psychological outcomes at 12 months. We did a one-stage individual participant data meta-analysis with a random-effects linear regression model, and a two-stage meta-analysis integrating individual participant data with aggregated data from studies that did not provide individual participant data. This study is registered with PROSPERO, CRD42018111005. FINDINGS: 9871 citations were identified through database searches. After exclusion of duplicates and publications not meeting inclusion criteria, 225 full texts were assessed for inclusion, of which 109 publications reporting 35 primary studies (with a total 5601 participants) were included. Of these, 17 trials provided individual participant data (3431 participants; median age 67 years [IQR 60-72]; 3281 [97%] of 3380 aged ≥40 years) Compared with placebo, testosterone treatment increased 15-item International Index of Erectile Function (IIEF-15) total score (mean difference 5·52 [95% CI 3·95-7·10]; τ2=1·17; n=1412) and IIEF-15 erectile function subscore (2·14 [1·40-2·89]; τ2=0·64; n=1436), reaching the minimal clinically important difference for mild erectile dysfunction. These effects were not found to be dependent on participant age, obesity, presence of diabetes, or baseline serum total testosterone. However, absolute IIEF-15 scores reached during testosterone treatment were subject to thresholds in patient age and baseline serum total testosterone. Testosterone significantly improved Aging Males' Symptoms score, and some 12-item or 36-item Short Form Survey quality of life subscores compared with placebo, but it did not significantly improve psychological symptoms (measured by Beck Depression Inventory). INTERPRETATION: In men aged 40 years or older with baseline serum testosterone of less than 12 nmol/L, short-to-medium-term testosterone treatment could provide clinically meaningful treatment for mild erectile dysfunction, irrespective of patient age, obesity, or degree of low testosterone. However, due to more severe baseline symptoms, the absolute level of sexual function reached during testosterone treatment might be lower in older men and men with obesity. FUNDING: National Institute for Health and Care Research Health Technology Assessment Programme.

Consumption of foods with the highest nutritional quality, and the lowest greenhouse gas emissions and price, differs between socio-economic groups in the UK population.

OBJECTIVE: To establish a baseline understanding of whether consuming food with the highest nutritional quality, lowest greenhouse gas emissions (GHGE) and cost differs between different UK demographic and socio-economic population groups. DESIGN: Multiple linear regression models were fitted to evaluate the relationship between predictor socio-demographic variables in this study (i.e. sex, ethnic group, age, BMI and level of deprivation) and the response variables (i.e. consumption of items considered most nutritious, with a low GHGE and price, as a proportion of total items consumed). SETTING: The UK. PARTICIPANTS: 1374 adult (18-65 years) participants from the National Diet and Nutrition Survey latest waves 9-11 (2016-2017 and 2018-2019). RESULTS: Based on the total energy consumption in a day, the average diet-based GHGE was significantly higher for participants with a higher BMI. Non-white and most deprived participants spent significantly (P < 0·001) less money per total energy consumption. Participants with a BMI between 18·6 and 39·9 kg/m2 and those living in the least deprived areas consumed a significantly (P < 0·001) higher amount of those items considered the most nutritious, with the lowest GHGE and cost per 100 kcal. CONCLUSIONS: Consumption of food with the highest nutritional quality, lowest GHGE and cost in the UK varies among those with different socio-demographic characteristics, especially the deprivation level of participants. Our analysis endorses the consideration of environmental sustainability and affordability, in addition to the consideration of nutritional quality from a health perspective, to make current dietary guidelines more encompassing and equitable.

Adverse cardiovascular events and mortality in men during testosterone treatment: an individual patient and aggregate data meta-analysis.

Background: Testosterone is the standard treatment for male hypogonadism, but there is uncertainty about its cardiovascular safety due to inconsistent findings. We aimed to provide the most extensive individual participant dataset (IPD) of testosterone trials available, to analyse subtypes of all cardiovascular events observed during treatment, and to investigate the effect of incorporating data from trials that did not provide IPD. Methods: We did a systematic review and meta-analysis of randomised controlled trials including IPD. We searched MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, MEDLINE Epub Ahead of Print, Embase, Science Citation Index, the Cochrane Controlled Trials Register, Cochrane Database of Systematic Reviews, and Database of Abstracts of Review of Effects for literature from 1992 onwards (date of search, Aug 27, 2018). The following inclusion criteria were applied: (1) men aged 18 years and older with a screening testosterone concentration of 12 nmol/L (350 ng/dL) or less; (2) the intervention of interest was treatment with any testosterone formulation, dose frequency, and route of administration, for a minimum duration of 3 months; (3) a comparator of placebo treatment; and (4) studies assessing the pre-specified primary or secondary outcomes of interest. Details of study design, interventions, participants, and outcome measures were extracted from published articles and anonymised IPD was requested from investigators of all identified trials. Primary outcomes were mortality, cardiovascular, and cerebrovascular events at any time during follow-up. The risk of bias was assessed using the Cochrane Risk of Bias tool. We did a one-stage meta-analysis using IPD, and a two-stage meta-analysis integrating IPD with data from studies not providing IPD. The study is registered with PROSPERO, CRD42018111005. Findings: 9871 citations were identified through database searches and after exclusion of duplicates and of irrelevant citations, 225 study reports were retrieved for full-text screening. 116 studies were subsequently excluded for not meeting the inclusion criteria in terms of study design and characteristics of intervention, and 35 primary studies (5601 participants, mean age 65 years, [SD 11]) reported in 109 peer-reviewed publications were deemed suitable for inclusion. Of these, 17 studies (49%) provided IPD (3431 participants, mean duration 9·5 months) from nine different countries while 18 did not provide IPD data. Risk of bias was judged to be low in most IPD studies (71%). Fewer deaths occurred with testosterone treatment (six [0·4%] of 1621) than placebo (12 [0·8%] of 1537) without significant differences between groups (odds ratio [OR] 0·46 [95% CI 0·17-1·24]; p=0·13). Cardiovascular risk was similar during testosterone treatment (120 [7·5%] of 1601 events) and placebo treatment (110 [7·2%] of 1519 events; OR 1·07 [95% CI 0·81-1·42]; p=0·62). Frequently occurring cardiovascular events included arrhythmia (52 of 166 vs 47 of 176), coronary heart disease (33 of 166 vs 33 of 176), heart failure (22 of 166 vs 28 of 176), and myocardial infarction (10 of 166 vs 16 of 176). Overall, patient age (interaction 0·97 [99% CI 0·92-1·03]; p=0·17), baseline testosterone (interaction 0·97 [0·82-1·15]; p=0·69), smoking status (interaction 1·68 [0·41-6·88]; p=0.35), or diabetes status (interaction 2·08 [0·89-4·82; p=0·025) were not associated with cardiovascular risk. Interpretation: We found no evidence that testosterone increased short-term to medium-term cardiovascular risks in men with hypogonadism, but there is a paucity of data evaluating its long-term safety. Long-term data are needed to fully evaluate the safety of testosterone. Funding: National Institute for Health Research Health Technology Assessment Programme.

Food-Level Analysis to Identify Dietary Choices With the Highest Nutritional Quality and Lowest Greenhouse Gas Emissions and Price.

Introduction: Food systems are challenged to provide healthy, sustainable and affordable foods. From a consumer perspective, identifying healthy, sustainable and affordable choices based on individual food products rather than diets could promote better shopping choices. Objective: To identify foods and drinks with the highest nutritional quality and lowest greenhouse gas emissions (GHGE) and price. We also assessed how a combination of these indicators (e.g., nutritional quality, GHGE and price) for food categories aligned with current United Kingdom dietary recommendations. Materials and Methods: We performed a secondary analysis of the National Diet and Nutrition Survey (NDNS) nutrient databank year 11 (2018/2019). Spearman correlation coefficients were used to assess the strength of relationships between nutritional quality, environmental impact and/or prices per 100 kcal. In addition, we developed an optimized nutritional quality, GHGE and price score for each food or drink item based on the overall medians for each of these indicators. Results: Median nutritional value was highest for fruit and vegetables, whilst median GHGE and price was lower for starchy carbohydrates, fats and items of which consumption should be limited. The relative proportions of foods considered the most nutritious and with a low GHGE and price in each of the food categories, on a per 100 kcal basis, were comparable to the proportions in the Eatwell Guide, except for the proportion of fruits and vegetables being smaller and the proportion of potatoes, bread, rice, pasta, and other starchy carbohydrates being larger in our analysis. Conclusion: Public health efforts should consider the impact of dietary choices not only in terms of nutritional quality but also in terms of environmental and economic impact. Our food-based analysis shows a large variation in nutritional quality, GHGE and price within and across food categories, which provides consumers with opportunities for "food swaps" that are more nutritious and have lower GHGE and price.

Does weight management research for adults with severe obesity represent them? Analysis of systematic review data.

OBJECTIVE: Our objective was to determine the extent to which current evidence from long-term randomised controlled trials (RCTs) of weight management is generalisable and applicable to underserved adult groups with obesity (body mass index (BMI) ≥35 kg/m2). METHODS: Descriptive analysis of 131 RCTs, published after 1990-May 2017 with ≥1 year of follow-up, included in a systematic review of long-term weight management interventions for adults with BMI ≥35 kg/m2 (the REBALANCE Project). Studies were identified from MEDLINE, EMBASE, PsychINFO, SCI, CENTRAL and from hand searching. Reporting of trial inclusion and exclusion criteria, trial recruitment strategies, baseline characteristics and outcomes were analysed using a predefined list of characteristics informed by the PROGRESS (Place of residence, Race/ethnicity/culture/language, Occupation, Gender/sex, Religion, Education, Socioeconomic status, Social capital)-Plus framework and the UK Equality Act 2010. RESULTS: Few (6.1%) trials reported adapting recruitment to appeal to underserved groups. 10.0% reported culturally adapting their trial materials. Only 6.1% of trials gave any justification for their exclusion criteria, yet over half excluded participation for age or mental health reasons. Just over half (58%) of the trials reported participants' race or ethnicity, and one-fifth reported socioeconomic status. Where outcomes were reported for underserved groups, the most common analysis was by sex (47.3%), followed by race or ethnicity (16.8%). 3.1% of trials reported outcomes according to socioeconomic status. DISCUSSION: Although we were limited by poor trial reporting, our results indicate inadequate representation of people most at risk of obesity. Guidance for considering underserved groups may improve the appropriateness of research and inform greater engagement with health and social care services. FUNDING: National Institute for Health Research Health Technology Assessment Programme (project number: 15/09/04). PROSPERO REGISTRATION NUMBER: CRD42016040190.

Nutritional Quality, Environmental Impact and Cost of Ultra-Processed Foods: A UK Food-Based Analysis.

Food-based analyses of the healthiness, environmental sustainability and affordability of processed and ultra-processed foods are lacking. This paper aimed to determine how ultra-processed and processed foods compare to fresh and minimally processed foods in relation to nutritional quality, greenhouse gas emissions and cost on the food and food group level. Data from the National Diet and Nutrition Survey nutrient databank year 11 (2018/2019) were used for this analysis. Median and bootstrapped medians of nutritional quality (NRF8.3 index), greenhouse gas emissions (gCO2-equivalents) and cost (in GBP) were compared across processing categories. An optimal score based on the medians was created to identify the most nutritional, sustainable, and affordable options across processing categories. On a per 100 kcal basis, ultra-processed and processed foods had a lower nutritional quality, lower greenhouse gas emissions, and were cheaper than minimally processed foods, regardless of their total fat, salt and/or sugar content. The most nutritious, environmentally friendly, and affordable foods were generally lower in total fat, salt, and sugar, irrespective of processing level. The high variability in greenhouse gas emissions and cost across food groups and processing levels offer opportunities for food swaps representing the healthiest, greenest, and most affordable options.

Biomarkers for assessing acute kidney injury for people who are being considered for admission to critical care: a systematic review and cost-effectiveness analysis.

BACKGROUND: Acute kidney injury is a serious complication that occurs in the context of an acute critical illness or during a postoperative period. Earlier detection of acute kidney injury may facilitate strategies to preserve renal function, prevent further disease progression and reduce mortality. Acute kidney injury diagnosis relies on a rise in serum creatinine levels and/or fall in urine output; however, creatinine is an imperfect marker of kidney function. There is interest in the performance of novel biomarkers used in conjunction with existing clinical assessment, such as NephroCheck® (Astute Medical, Inc., San Diego, CA, USA), ARCHITECT® urine neutrophil gelatinase-associated lipocalin (NGAL) (Abbott Laboratories, Abbott Park, IL, USA), and urine and plasma BioPorto NGAL (BioPorto Diagnostics A/S, Hellerup, Denmark) immunoassays. If reliable, these biomarkers may enable earlier identification of acute kidney injury and enhance management of those with a modifiable disease course. OBJECTIVE: The objective was to evaluate the role of biomarkers for assessing acute kidney injury in critically ill patients who are considered for admission to critical care. DATA SOURCES: Major electronic databases, conference abstracts and ongoing studies were searched up to June 2019, with no date restrictions. MEDLINE, EMBASE, Health Technology Assessment Database, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, Web of Science, World Health Organization Global Index Medicus, EU Clinical Trials Register, International Clinical Trials Registry Platform and ClinicalTrials.gov were searched. REVIEW METHODS: A systematic review and meta-analysis were conducted to evaluate the performance of novel biomarkers for the detection of acute kidney injury and prediction of other relevant clinical outcomes. Random-effects models were adopted to combine evidence. A decision tree was developed to evaluate costs and quality-adjusted life-years accrued as a result of changes in short-term outcomes (up to 90 days), and a Markov model was used to extrapolate results over a lifetime time horizon. RESULTS: A total of 56 studies (17,967 participants), mainly prospective cohort studies, were selected for inclusion. No studies addressing the clinical impact of the use of biomarkers on patient outcomes, compared with standard care, were identified. The main sources of bias across studies were a lack of information on blinding and the optimal threshold for NGAL. For prediction studies, the reporting of statistical details was limited. Although the meta-analyses results showed the potential ability of these biomarkers to detect and predict acute kidney injury, there were limited data to establish any causal link with longer-term health outcomes and there were considerable clinical differences across studies. Cost-effectiveness results were highly uncertain, largely speculative and should be interpreted with caution in the light of the limited evidence base. To illustrate the current uncertainty, 15 scenario analyses were undertaken. Incremental quality-adjusted life-years were very low across all scenarios, ranging from positive to negative increments. Incremental costs were also small, in general, with some scenarios generating cost savings with tests dominant over standard care (cost savings with quality-adjusted life-year gains). However, other scenarios generated results whereby the candidate tests were more costly with fewer quality-adjusted life-years, and were thus dominated by standard care. Therefore, it was not possible to determine a plausible base-case incremental cost-effectiveness ratio for the tests, compared with standard care. LIMITATIONS: Clinical effectiveness and cost-effectiveness results were hampered by the considerable heterogeneity across identified studies. Economic model predictions should also be interpreted cautiously because of the unknown impact of NGAL-guided treatment, and uncertain causal links between changes in acute kidney injury status and changes in health outcomes. CONCLUSIONS: Current evidence is insufficient to make a full appraisal of the role and economic value of these biomarkers and to determine whether or not they provide cost-effective improvements in the clinical outcomes of acute kidney injury patients. FUTURE WORK: Future studies should evaluate the targeted use of biomarkers among specific patient populations and the clinical impact of their routine use on patient outcomes and management. STUDY REGISTRATION: This study is registered as PROSPERO CRD42019147039. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Evidence Synthesis programme and will be published in full in Health Technology Assessment; Vol. 26, No. 7. See the NIHR Journals Library website for further project information.

Among people who are very ill or have undergone surgery, the kidneys may suddenly stop working properly. This is known as acute kidney injury. Acute kidney injury can progress to serious kidney problems and can be fatal. Currently, to decide whether or not acute kidney injury is present, doctors use the level of creatinine (a waste product filtered by the kidneys) in the blood or urine. However, creatinine levels are not a precise indicator and they can take hours or days to rise; this may lead to delays in acute kidney injury recognition. Novel biomarkers may help doctors to recognise the presence of acute kidney injury earlier and treat patients promptly. This work evaluates current evidence on the use of biomarkers for acute kidney injury with respect to clinical usefulness and costs. We reviewed the current evidence on the use of biomarkers for assessing the risk of acute kidney injury among people who are very ill, and assessed whether or not the evidence was of good value for the NHS. We assessed the ARCHITECT^® urine neutrophil gelatinase-associated lipocalin (NGAL) (Abbott Laboratories, Abbott Park, IL, USA), urine and plasma BioPorto NGAL (BioPorto Diagnostics A/S, Hellerup, Denmark) and urine NephroCheck^® (Astute Medical, Inc., San Diego, CA, USA) biomarkers. We checked studies published up to June 2019 and found 56 relevant studies (17,967 patients). Most studies were conducted outside the UK and investigated people already admitted to critical care. We combined the results of the studies and found that NephroCheck and NGAL biomarkers might be useful in identifying acute kidney injury or pre-empting acute kidney injury in some circumstances. However, studies differed in patient characteristics, clinical setting and the way in which biomarkers were used. This could explain why the number of people correctly identified and missed by the biomarkers varied across studies. Hence, we do not completely trust the pooled results. We also found that acute kidney injury is associated with substantial costs for the NHS, but there was insufficient good-quality evidence to decide which biomarker (if any) offered the best value for money.

Cost-effectiveness and value of information analysis of NephroCheck and NGAL tests compared to standard care for the diagnosis of acute kidney injury.

BACKGROUND: Early and accurate acute kidney injury (AKI) detection may improve patient outcomes and reduce health service costs. This study evaluates the diagnostic accuracy and cost-effectiveness of NephroCheck and NGAL (urine and plasma) biomarker tests used alongside standard care, compared with standard care to detect AKI in hospitalised UK adults. METHODS: A 90-day decision tree and lifetime Markov cohort model predicted costs, quality adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs) from a UK NHS perspective. Test accuracy was informed by a meta-analysis of diagnostic accuracy studies. Clinical trial and observational data informed the link between AKI and health outcomes, health state probabilities, costs and utilities. Value of information (VOI) analysis informed future research priorities. RESULTS: Under base case assumptions, the biomarker tests were not cost-effective with ICERs of £105,965 (NephroCheck), £539,041 (NGAL urine BioPorto), £633,846 (NGAL plasma BioPorto) and £725,061 (NGAL urine ARCHITECT) per QALY gained compared to standard care. Results were uncertain, due to limited trial data, with probabilities of cost-effectiveness at £20,000 per QALY ranging from 0 to 99% and 0 to 56% for NephroCheck and NGAL tests respectively. The expected value of perfect information (EVPI) was £66 M, which demonstrated that additional research to resolve decision uncertainty is worthwhile. CONCLUSIONS: Current evidence is inadequate to support the cost-effectiveness of general use of biomarker tests. Future research evaluating the clinical and cost-effectiveness of test guided implementation of protective care bundles is necessary. Improving the evidence base around the impact of tests on AKI staging, and of AKI staging on clinical outcomes would have the greatest impact on reducing decision uncertainty.

Impact of a youth-led social marketing intervention run by adolescents to encourage healthy lifestyles among younger school peers (EYTO-Kids project): a parallel-cluster randomised controlled pilot study.

BACKGROUND: Encouraging healthy lifestyles in children is a challenge. This project aimed to improve lifestyles of younger peers by engaging adolescent creators (ACs) to design and implement peer-led and social marketing (SM) health-promoting activities. METHODS: A 10-month parallel-cluster randomised controlled school-based pilot study was performed in disadvantaged neighbourhoods in Reus (Spain) spanning two academic years (2015-2016/2016-2017). Eight primary schools (n=375 children) and four high schools (n=94ACs) were randomly placed in the intervention group. The 94 ACs (12-14 years) designed and implemented four SM activities for their younger peers (9-11 years). Eight primary schools (n=327 children) and three high schools (n=98 adolescents) served as the control group and received no intervention. Primary (physical activity and fruit consumption) and secondary outcomes (screen time, vegetables, soft drinks, sweets and fast food consumptions) were assessed with validated questionnaires at baseline and at the end of the study. RESULTS: After 10 months, fruit consumption and physical activity were maintained in the children who consumed ≥1 fruit/day and spent ≥6 hours/week physical activity. However, compared with the controls, the intervention significantly increased the physical activity of girls to 15.6 min/week, whereas the percentage of girls who consumed sweets, soft drinks and fast food decreased significantly by 8.4%, 14.5% and 5.9%, respectively. Additionally, the percentage of ≥2 hour/weekday of screen time by boys decreased significantly by 8.2%. CONCLUSION: The European Youth Tackling Obesity-Kids, SM and peer-led intervention, effectively increased physical activity hours/week in girls, but was not effective in improving the percentage of children who consumed the recommended fruit. Moreover, the percentages of girls who consumed sweets, soft drinks and fast food and boys screen time decreased. TRIAL REGISTRATION NUMBER: NCT02702336; Pre-results.

Bariatric surgery, lifestyle interventions and orlistat for severe obesity: the REBALANCE mixed-methods systematic review and economic evaluation.

BACKGROUND: Adults with severe obesity [body mass index (BMI) of ≥ 35 kg/m2] have an increased risk of comorbidities and psychological, social and economic consequences. OBJECTIVES: Systematically review bariatric surgery, weight-management programmes (WMPs) and orlistat pharmacotherapy for adults with severe obesity, and evaluate the feasibility, acceptability, clinical effectiveness and cost-effectiveness of treatment. DATA SOURCES: Electronic databases including MEDLINE, EMBASE, PsycINFO, the Cochrane Central Register of Controlled Trials and the NHS Economic Evaluation Database were searched (last searched in May 2017). REVIEW METHODS: Four systematic reviews evaluated clinical effectiveness, cost-effectiveness and qualitative evidence for adults with a BMI of ≥ 35 kg/m2. Data from meta-analyses populated a microsimulation model predicting costs, outcomes and cost-effectiveness of Roux-en-Y gastric bypass (RYGB) surgery and the most effective lifestyle WMPs over a 30-year time horizon from a NHS perspective, compared with current UK population obesity trends. Interventions were cost-effective if the additional cost of achieving a quality-adjusted life-year is < £20,000-30,000. RESULTS: A total of 131 randomised controlled trials (RCTs), 26 UK studies, 33 qualitative studies and 46 cost-effectiveness studies were included. From RCTs, RYGB produced the greatest long-term weight change [-20.23 kg, 95% confidence interval (CI) -23.75 to -16.71 kg, at 60 months]. WMPs with very low-calorie diets (VLCDs) produced the greatest weight loss at 12 months compared with no WMPs. Adding a VLCD to a WMP gave an additional mean weight change of -4.41 kg (95% CI -5.93 to -2.88 kg) at 12 months. The intensive Look AHEAD WMP produced mean long-term weight loss of 6% in people with type 2 diabetes mellitus (at a median of 9.6 years). The microsimulation model found that WMPs were generally cost-effective compared with population obesity trends. Long-term WMP weight regain was very uncertain, apart from Look AHEAD. The addition of a VLCD to a WMP was not cost-effective compared with a WMP alone. RYGB was cost-effective compared with no surgery and WMPs, but the model did not replicate long-term cost savings found in previous studies. Qualitative data suggested that participants could be attracted to take part in WMPs through endorsement by their health-care provider or through perceiving innovative activities, with WMPs being delivered to groups. Features improving long-term weight loss included having group support, additional behavioural support, a physical activity programme to attend, a prescribed calorie diet or a calorie deficit. LIMITATIONS: Reviewed studies often lacked generalisability to UK settings in terms of participants and resources for implementation, and usually lacked long-term follow-up (particularly for complications for surgery), leading to unrealistic weight regain assumptions. The views of potential and actual users of services were rarely reported to contribute to service design. This study may have failed to identify unpublished UK evaluations. Dual, blinded numerical data extraction was not undertaken. CONCLUSIONS: Roux-en-Y gastric bypass was costly to deliver, but it was the most cost-effective intervention. Adding a VLCD to a WMP was not cost-effective compared with a WMP alone. Most WMPs were cost-effective compared with current population obesity trends. FUTURE WORK: Improved reporting of WMPs is needed to allow replication, translation and further research. Qualitative research is needed with adults who are potential users of, or who fail to engage with or drop out from, WMPs. RCTs and economic evaluations in UK settings (e.g. Tier 3, commercial programmes or primary care) should evaluate VLCDs with long-term follow-up (≥ 5 years). Decision models should incorporate relevant costs, disease states and evidence-based weight regain assumptions. STUDY REGISTRATION: This study is registered as PROSPERO CRD42016040190. FUNDING: The National Institute for Health Research Health Technology Assessment programme. The Health Services Research Unit and Health Economics Research Unit are core funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorate.

Cost-Effectiveness of the EdAl (Educació en Alimentació) Program: A Primary School-Based Study to Prevent Childhood Obesity.

BACKGROUND: The cost-effectiveness of childhood obesity prevention interventions is critical for their sustained implementation. This study evaluated the cost-effectiveness of the Educació en Alimentació (EdAl) program, a school-based intervention for reducing obesity. METHODS: Total EdAl program implementation costs and per-child costs were estimated. Cost-effectiveness, defined using the incremental cost-effectiveness ratio (ICER), was estimated as the difference between the intervention and control group costs divided by the obesity-related outcome effects for boys (avoided cases of obesity, obesity prevalence, body mass index [BMI], and BMI z-score units) for each group. As a significant difference (4.39%) in the reduction of obesity prevalence between the intervention and control groups was observed for boys in the EdAl program, the data were calculated only for boys. RESULTS: The intervention cost was 24,246.53 € for 1,550 children (15.64 €/child/3 years) or 5.21 €/child/year. The ICERs/boy were 968.66 € to avoid one case of obesity, 3.6 € to reduce the obesity prevalence by 1%, 44.68 € to decrease BMI by one unit, and 65.16 € to reduce the BMI z-score by one unit. CONCLUSIONS: The cost of reducing the obesity prevalence in boys by 4.39% was 5.21 €/child/year, half the cost proposed by the Spanish Health Ministry, indicating that the EdAl program is cost-effective.

Obesity-promoting factors in Mexican children and adolescents: challenges and opportunities.

BACKGROUND: Mexico is a developing country with one of the highest youth obesity rates worldwide; >34% of children and adolescents between 5 and 19 years of age are overweight or obese. OBJECTIVES: The current review seeks to compile, describe, and analyze dietary conditions, physical activity, socioeconomic status, and cultural factors that create and exacerbate an obesogenic environment among Mexican youth. DESIGN: A narrative review was performed using PubMed and the Cochrane Library databases, as well as grey literature data from the Mexican government, academics, and statistical reports from nongovernmental organizations, included in electronic formats. RESULTS: The recent socioeconomic and nutritional transition has resulted in reduced healthy meal options at public schools, high rates of sedentary lifestyles among adolescents, lack of open spaces and playgrounds, socioeconomic deprivation, false or misunderstood sociocultural traditional beliefs, misconceptions about health, a high percentage of overweight or obese adults, and low rates of maternal breastfeeding. Some of the factors identified are exacerbating the obesity problem in this population. Current evidence also shows that more policies and health programs are needed for prevention of childhood and adolescent obesity. Mexico presents alarming obesity levels, which need to be curtailed and urgently reversed. CONCLUSIONS: The present narrative review presents an overview of dietary, physical activity, societal and cultural preconceptions that are potentially modifiable obesity-promoting factors in Mexican youth. Measures to control these factors need to be implemented in all similar developing countries by governments, policy makers, stakeholders, and health care professionals to tackle obesity in children and young people.