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Objectives: This study aimed to develop and apply a structured approach for prioritising topics for systematic reviews in public health, framed according to the readily applicable PICO format, which encourages the involvement of stakeholders' preferences in a transparent matter., Methods: We developed a multi-stage process, consisting of a scoping and two Delphi stages with web-based surveys and invited public health stakeholders in Switzerland to participate: First, respondents specified topics for different public health domains, which were reformulated in a PICO format by content analysis. Second, respondents rated the topics using five stakeholder-refined assessment criteria. Overall rankings were calculated to assess differences between stakeholder groups and rating criteria., Results: In total, 215 respondents suggested 728 topics altogether. The response rate in the two Delphi stages was 91.6% and 77.6%, respectively. Most top-rated review topics focused on the effectiveness of interventions providing education to different target groups, followed by interventions to increase access to specific healthcare services., Conclusion: Our approach encourages involvement of stakeholders in identifying priorities for systematic reviews and highlights disparities between stakeholders and between individual criteria., Competing Interests: The authors declare that they do not have any conflicts of interest., (Copyright © 2024 Hoekstra, Mütsch, Borchard, Kien, Griebler, Von Elm, Rehfuess, Gerhardus and Lhachimi.)

Background: Research priority setting (RPS) studies are necessary to close the significant gap between the scientific evidence produced and the evidence stakeholders need. Their findings can make resource allocation in research more efficient. However, no general framework for conducting an RPS study among public health stakeholders exists. RPS studies in public health are rare and no such study has been previously conducted and published in Germany. Therefore, we aimed to investigate which research topics in public health are prioritised by relevant stakeholders in Germany., Methods: Our RPS study consisted of a scoping stage and a Delphi stage each split into two rounds. Firstly, we invited members of the German Public Health Association to gather expert insights during two initial workshops. Next, we defined the relevant stakeholder groups and recruited respondents. Thereafter, we collected research topics and assessment criteria with the respondents in the first Delphi round and aggregated the responses through content analysis. Finally, we asked the respondents to rate the research topics with the assessment criteria in the second Delphi round., Results: In total, 94 out of the 140 invited public health organisations nominated 230 respondents for the Delphi study of whom almost 90% participated in both Delphi rounds. We compiled a comprehensive list of 76 research topics that were rated and ranked by several assessment criteria. We split the research topics into two types, substantive research topics and methodological-theoretical research topics respectively, to ensure the comparability among the research topics. In both types of research topics-substantive research topics and methodological-theoretical research topics-the respective top five ranked research topics hardly differed between public health researchers and public health practitioners. However, clear differences exist in the priority ranking of many (non-top priority) research topics between the stakeholder groups., Conclusions: This research demonstrates that it is possible, with limited resources, to prioritise research topics for public health at the national level involving a wide range of pertinent stakeholders. The results can be used by research funding institutions to initiate calls for research projects with an increased relevance for health and/or scientific progress., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background and Objectives: Assessing changes in coverage, recall, review, conclusions and references not found when searching fewer databases., Methods: In randomly selected 60 Cochrane reviews, we checked included study publications' coverage (indexation) and recall (findability) using different search approaches with MEDLINE, Embase, and CENTRAL and related them to authors' conclusions and certainty. We assessed characteristics of unfound references., Results: Overall 1989/2080 included references, were indexed in ≥1 database (coverage = 96%). In reviews where using one of our search approaches would not change conclusions and certainty (n = 44-54), median coverage and recall were highest (range 87.9%-100.0% and 78.2%-93.3%, respectively). Here, searching ≥2 databases reached >95% coverage and ≥87.9% recall. In reviews with unchanged conclusions but less certainty (n = 2-8): 63.3%-79.3% coverage and 45.0%-75.0% recall. In reviews with opposite conclusions (n = 1-3): 63.3%-96.6% and 52.1%-78.7%. In reviews where a conclusion was no longer possible (n = 3-7): 60.6%-86.0% and 20.0%-53.8%. The 265 references that were indexed but unfound were more often abstractless (30% vs. 11%) and older (28% vs. 17% published before 1991) than found references., Conclusion: Searching ≥2 databases improves coverage and recall and decreases the risk of missing eligible studies. If researchers suspect that relevant articles are difficult to find, supplementary search methods should be used., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Unconditional cash transfers (UCTs; provided without obligation) for reducing poverty and vulnerabilities (e.g. orphanhood, old age, or HIV infection) are a social protection intervention addressing a key social determinant of health (income) in low- and middle-income countries (LMICs). The relative effectiveness of UCTs compared with conditional cash transfers (CCTs; provided only if recipients follow prescribed behaviours, e.g. use a health service or attend school) is unknown., Objectives: To assess the effects of UCTs on health services use and health outcomes in children and adults in LMICs. Secondary objectives are to assess the effects of UCTs on social determinants of health and healthcare expenditure, and to compare the effects of UCTs versus CCTs., Search Methods: For this update, we searched 15 electronic academic databases, including CENTRAL, MEDLINE and EconLit, in September 2021. We also searched four electronic grey literature databases, websites of key organisations and reference lists of previous systematic reviews, key journals and included study records., Selection Criteria: We included both parallel-group and cluster-randomised controlled trials (C-RCTs), quasi-RCTs, cohort studies, controlled before-and-after studies (CBAs), and interrupted time series studies of UCT interventions in children (0 to 17 years) and adults (≥ 18 years) in LMICs. Comparison groups received either no UCT, a smaller UCT or a CCT. Our primary outcomes were any health services use or health outcome., Data Collection and Analysis: Two review authors independently screened potentially relevant records for inclusion, extracted data and assessed the risk of bias. We obtained missing data from study authors if feasible. For C-RCTs, we generally calculated risk ratios for dichotomous outcomes from crude frequency measures in approximately correct analyses. Meta-analyses applied the inverse variance or Mantel-Haenszel method using a random-effects model. Where meta-analysis was impossible, we synthesised results using vote counting based on effect direction. We assessed the certainty of the evidence using GRADE., Main Results: We included 34 studies (25 studies of 20 C-RCTs, six CBAs, and three cohort studies) involving 1,140,385 participants (45,538 children, 1,094,847 adults) and 50,095 households in Africa, the Americas and South-East Asia in our meta-analyses and narrative syntheses. These analysed 29 independent data sets. The 24 UCTs identified, including one basic universal income intervention, were pilot or established government programmes or research experiments. The cash value was equivalent to 1.3% to 81.9% of the annualised gross domestic product per capita. All studies compared a UCT with no UCT; three studies also compared a UCT with a CCT. Most studies carried an overall high risk of bias (i.e. often selection or performance bias, or both). Most studies were funded by national governments or international organisations, or both. Throughout the review, we use the words 'probably' to indicate moderate-certainty evidence, 'may/maybe' for low-certainty evidence, and 'uncertain' for very low-certainty evidence. Health services use We assumed greater use of any health services to be beneficial. UCTs may not have impacted the likelihood of having used any health service in the previous 1 to 12 months, when participants were followed up between 12 and 24 months into the intervention (risk ratio (RR) 1.04, 95% confidence interval (CI) 1.00 to 1.09; I 2 = 2%; 5 C-RCTs, 4972 participants; low-certainty evidence). Health outcomes At one to two years, UCTs probably led to a clinically meaningful, very large reduction in the likelihood of having had any illness in the previous two weeks to three months (RR 0.79, 95% CI 0.67 to 0.92; I 2 = 53%; 6 C-RCTs, 9367 participants; moderate-certainty evidence). UCTs may have increased the likelihood of having been food secure over the previous month, at 13 to 36 months into the intervention (RR 1.25, 95% CI 1.09 to 1.45; I 2 = 85%; 5 C-RCTs, 2687 participants; low-certainty evidence). UCTs may have increased participants' level of dietary diversity over the previous week, when assessed with the Household Dietary Diversity Score and followed up 24 months into the intervention (mean difference (MD) 0.59 food categories, 95% CI 0.18 to 1.01; I 2 = 79%; 4 C-RCTs, 9347 participants; low-certainty evidence). Despite several studies providing relevant evidence, the effects of UCTs on the likelihood of being moderately stunted and on the level of depression remain uncertain. We found no study on the effect of UCTs on mortality risk. Social determinants of health UCTs probably led to a clinically meaningful, moderate increase in the likelihood of currently attending school, when assessed at 12 to 24 months into the intervention (RR 1.06, 95% CI 1.04 to 1.09; I 2 = 0%; 8 C-RCTs, 7136 participants; moderate-certainty evidence). UCTs may have reduced the likelihood of households being extremely poor, at 12 to 36 months into the intervention (RR 0.92, 95% CI 0.87 to 0.97; I 2 = 63%; 6 C-RCTs, 3805 participants; low-certainty evidence). The evidence was uncertain for whether UCTs impacted livestock ownership, participation in labour, and parenting quality. Healthcare expenditure Evidence from eight cluster-RCTs on healthcare expenditure was too inconsistent to be combined in a meta-analysis, but it suggested that UCTs may have increased the amount of money spent on health care at 7 to 36 months into the intervention (low-certainty evidence). Equity, harms and comparison with CCTs The effects of UCTs on health equity (or unfair and remedial health inequalities) were very uncertain. We did not identify any harms from UCTs. Three cluster-RCTs compared UCTs versus CCTs with regard to the likelihood of having used any health services or had any illness, or the level of dietary diversity, but evidence was limited to one study per outcome and was very uncertain for all three., Authors' Conclusions: This body of evidence suggests that unconditional cash transfers (UCTs) may not impact a summary measure of health service use in children and adults in LMICs. However, UCTs probably or may improve some health outcomes (i.e. the likelihood of having had any illness, the likelihood of having been food secure, and the level of dietary diversity), two social determinants of health (i.e. the likelihoods of attending school and being extremely poor), and healthcare expenditure. The evidence on the relative effectiveness of UCTs and CCTs remains very uncertain., (Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Background and Objective: This article explores the need for conceptual advances and practical guidance in the application of the GRADE approach within public health contexts., Methods: We convened an expert workshop and conducted a scoping review to identify challenges experienced by GRADE users in public health contexts. We developed this concept article through thematic analysis and an iterative process of consultation and discussion conducted with members electronically and at three GRADE Working Group meetings., Results: Five priority issues can pose challenges for public health guideline developers and systematic reviewers when applying GRADE: (1) incorporating the perspectives of diverse stakeholders; (2) selecting and prioritizing health and "nonhealth" outcomes; (3) interpreting outcomes and identifying a threshold for decision-making; (4) assessing certainty of evidence from diverse sources, including nonrandomized studies; and (5) addressing implications for decision makers, including concerns about conditional recommendations. We illustrate these challenges with examples from public health guidelines and systematic reviews, identifying gaps where conceptual advances may facilitate the consistent application or further development of the methodology and provide solutions., Conclusion: The GRADE Public Health Group will respond to these challenges with solutions that are coherent with existing guidance and can be consistently implemented across public health decision-making contexts., (Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objective: This study aimed to dynamically model and quantify expected health effects of four scenarios: (i) a reference scenario with an unchanged fruit and vegetable intake, (ii) the removal of value-added tax (VAT) on fruits and vegetables, (iii) the implementation of a 20 % subsidy on fruits and vegetables and (iv) a guideline scenario with a population-wide fruit and vegetable intake of five portions per day., Design: Baseline fruit and vegetable intake data was derived from the GEDA 2012 study. We used price elasticities for Germany to calculate the change in fruit and vegetable consumption under the zero VAT and the 20 % subsidy scenario. All scenarios were modelled over a 10-year projection period using DYNAMO-HIA., Setting: Germany., Participants: A projected real-life population., Results: Cumulated over the 10-year projection period, an estimated 4450 incident ischaemic heart disease (IHD) cases, 7010 stroke cases and 13 960 deaths would be prevented under the zero VAT scenario. Under the 20 % subsidy scenario, 17 990 incident IHD cases, 27 390 stroke cases and 54 880 deaths would be averted. Although this corresponds to only a fraction of the incidents that would occur under the reference scenario, the averted cases translate to 2 % (for the zero VAT scenario) and 9 % (for the 20 % subsidy scenario) of IHD, stroke and death cases that would be prevented if the whole population consumed the recommended five portions of fruits and vegetables per day., Conclusions: Fiscal policies on fruits and vegetables provide a non-negligible step towards the removal of the health burden induced by low fruit and vegetable intake.

Background and Aims: In 2004, Sweden had to allow virtually unlimited private alcohol imports from other EU countries. Purchases from abroad in addition to the sales from Systembolaget stores (Sweden's alcohol retail monopoly) are a significant source of alcohol consumption in southern Sweden. However, survey studies designed to measure the expected increase in overall alcohol consumption in southern Sweden failed to detect a meaningful change. Since this was considered 'puzzling', this study aims to (at least partially) provide an explanation for this finding by testing an economic proposition, i.e., a coincidental and sudden increase in petrol prices reduced the affordability of private alcohol imports., Methods: Using monthly sales at the provincial level covering Jan 1997-Dec 2005 for beer and spirits, we employed a fixed-effect panel design. Two models were examined: (i) a model investigating the relationship between distance, petrol prices and alcohol sales before the liberalization, and (ii) a model investigating this relationship after the liberalization., Results: The model before the liberalization showed, as expected, that domestic alcohol sales decrease when petrol prices decrease. However, the model after the liberalization model revealed that the effect of petrol prices on beer sales depends on the (traveling) distance from the borders and, after full liberalization, the coefficients for petrol prices become positive. For spirits, the results were inconclusive., Conclusion: In the aftermath of import liberalization of the Swedish alcohol market, increased petrol prices temporarily made private alcohol imports economically unattractive for consumers living close to the border. This may partly explain why, after that event, surveys did not detect the widely expected increase in self-reported alcohol consumption.

Raising tobacco prices effectively reduces smoking, the main risk factor for chronic obstructive pulmonary disease (COPD). Using the Health Impact Assessment tool "DYNAMO-HIA", this study quantified the reduction in COPD burden that would occur in Italy, England and Sweden over 40 years if tobacco prices were increased by 5%, 10% and 20% over current local prices, with larger increases considered in secondary analyses. A dynamic Markov-based multi-state simulation modelling approach estimated the effect of changes in smoking prevalence states and probabilities of transitioning between smoking states on future smoking prevalence, COPD burden and life expectancy in each country. Data inputs included demographics, smoking prevalences and behaviour and COPD burden from national data resources, large observational cohorts and datasets within DYNAMO-HIA. In the 20% price increase scenario, the cumulative number of COPD incident cases saved over 40 years was 479,059 and 479,302 in Italy and England (populous countries with higher smoking prevalences) and 83,694 in Sweden (smaller country with lower smoking prevalence). Gains in overall life expectancy ranged from 0.25 to 0.45 years for a 20 year-old. Increasing tobacco prices would reduce COPD burden and increase life expectancy through smoking behavior changes, with modest but important public health benefits observed in all three countries.

Objectives: The objective of this study was to assess the agreement of treatment effect estimates from meta-analyses based on abbreviated or comprehensive literature searches., Study Design and Setting: This was a meta-epidemiological study. We abbreviated 47 comprehensive Cochrane review searches and searched MEDLINE/Embase/CENTRAL alone, in combination, with/without checking references (658 new searches). We compared one meta-analysis from each review with recalculated ones based on abbreviated searches., Results: The 47 original meta-analyses included 444 trials (median 6 per review [interquartile range (IQR) 3-11]) with 360045 participants (median 1,371 per review [IQR 685-8,041]). Depending on the search approach, abbreviated searches led to identical effect estimates in 34-79% of meta-analyses, to different effect estimates with the same direction and level of statistical significance in 15-51%, and to opposite effects (or effects could not be estimated anymore) in 6-13%. The deviation of effect sizes was zero in 50% of the meta-analyses and in 75% not larger than 1.07-fold. Effect estimates of abbreviated searches were not consistently smaller or larger (median ratio of odds ratio 1 [IQR 1-1.01]) but more imprecise (1.02-1.06-fold larger standard errors)., Conclusion: Abbreviated literature searches often led to identical or very similar effect estimates as comprehensive searches with slightly increased confidence intervals. Relevant deviations may occur., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Lead exposure is a serious health hazard, especially for children. It is associated with physical, cognitive and neurobehavioural impairment in children. There are many potential sources of lead in the environment, therefore trials have tested many household interventions to prevent or reduce lead exposure. This is an update of a previously published review., Objectives: To assess the effects of household interventions intended to prevent or reduce further lead exposure in children on improvements in cognitive and neurobehavioural development, reductions in blood lead levels and reductions in household dust lead levels., Search Methods: In March 2020, we updated our searches of CENTRAL, MEDLINE, Embase, 10 other databases and ClinicalTrials.gov. We also searched Google Scholar, checked the reference lists of relevant studies and contacted experts to identify unpublished studies., Selection Criteria: Randomised controlled trials (RCTs) and quasi-RCTs of household educational or environmental interventions, or combinations of interventions to prevent lead exposure in children (from birth to 18 years of age), where investigators reported at least one standardised outcome measure., Data Collection and Analysis: Two authors independently reviewed all eligible studies for inclusion, assessed risk of bias and extracted data. We contacted trialists to obtain missing information. We assessed the certainty of the evidence using the GRADE approach., Main Results: We included 17 studies (three new to this update), involving 3282 children: 16 RCTs (involving 3204 children) and one quasi-RCT (involving 78 children). Children in all studies were under six years of age. Fifteen studies took place in urban areas of North America, one in Australia and one in China. Most studies were in areas with low socioeconomic status. Girls and boys were equally represented in those studies reporting this information. The duration of the intervention ranged from three months to 24 months in 15 studies, while two studies performed interventions on a single occasion. Follow-up periods ranged from three months to eight years. Three RCTs were at low risk of bias in all assessed domains. The other 14 studies were at unclear or high risk of bias; for example, we considered two RCTs and one quasi-RCT at high risk of selection bias and six RCTs at high risk of attrition bias. National or international research grants or governments funded 15 studies, while the other two did not report their funding sources. Education interventions versus no intervention None of the included studies in this comparison assessed effects on cognitive or neurobehavioural outcomes, or adverse events. All studies reported data on blood lead level outcomes. Educational interventions showed there was probably no evidence of a difference in reducing blood lead levels (continuous: mean difference (MD) -0.03, 95% confidence interval (CI) -0.13 to 0.07; I² = 0%; 5 studies, 815 participants; moderate-certainty evidence; log-transformed data), or in reducing floor dust levels (MD -0.07, 95% CI -0.37 to 0.24; I² = 0%; 2 studies, 318 participants; moderate-certainty evidence). Environmental interventions versus no intervention Dust control: one study in this comparison reported data on cognitive and neurobehavioural outcomes, and on adverse events in children. The study showed numerically there may be better neurobehavioural outcomes in children of the intervention group. However, differences were small and the CI included both a beneficial and non-beneficial effect of the environmental intervention (e.g. mental development (Bayley Scales of Infant Development-II): MD 0.1, 95% CI -2.1 to 2.4; 1 study, 302 participants; low-certainty evidence). The same study did not observe any adverse events related to the intervention during the eight-year follow-up, but observed two children with adverse events in the control group (1 study, 355 participants; very low-certainty evidence). Meta-analysis also found no evidence of effectiveness on blood lead levels (continuous: MD -0.02, 95% CI -0.09 to 0.06; I² = 0%; 4 studies, 565 participants; moderate-certainty evidence; log-transformed data). We could not pool the data regarding floor dust levels, but studies reported that there may be no evidence of a difference between the groups (very low-certainty evidence). Soil abatement: the two studies assessing this environmental intervention only reported on the outcome of 'blood lead level'. One study showed a small effect on blood lead level reduction, while the other study showed no effect. Therefore, we deem the current evidence insufficient to draw conclusions about the effectiveness of soil abatement (very low-certainty evidence). Combination of educational and environmental interventions versus standard education Studies in this comparison only reported on blood lead levels and dust lead levels. We could not pool the studies in a meta-analysis due to substantial differences between the studies. Since the studies reported inconsistent results, the evidence is currently insufficient to clarify whether a combination of interventions reduces blood lead levels and floor dust levels (very low-certainty evidence)., Authors' Conclusions: Based on available evidence, household educational interventions and environmental interventions (namely dust control measures) show no evidence of a difference in reducing blood lead levels in children as a population health measure. The evidence of the effects of environmental interventions on cognitive and neurobehavioural outcomes and adverse events is uncertain too. Further trials are required to establish the most effective intervention for reducing or even preventing further lead exposure. Key elements of these trials should include strategies to reduce multiple sources of lead exposure simultaneously using empirical dust clearance levels. It is also necessary for trials to be carried out in low- and middle-income countries and in differing socioeconomic groups in high-income countries., (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Background: Overweight and obesity are increasing worldwide and are considered to be a major public health issue of the 21st century. Introducing taxation of the fat content in foods is considered a potentially powerful policy tool to reduce consumption of foods high in fat or saturated fat, or both., Objectives: To assess the effects of taxation of the fat content in food on consumption of total fat and saturated fat, energy intake, overweight, obesity, and other adverse health outcomes in the general population., Search Methods: We searched CENTRAL, Cochrane Database of Systematic Reviews, MEDLINE, Embase, and 15 other databases and trial registers on 12 September 2019. We handsearched the reference lists of all records of included studies, searched websites of international organizations and institutions (14 October 2019), and contacted review advisory group members to identify planned, ongoing, or unpublished studies (26 February 2020)., Selection Criteria: In line with Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria, we included the following study types: randomized controlled trials (RCTs), cluster-randomized controlled trials (cRCTs), non-randomized controlled trials (nRCTs), controlled before-after (CBA) studies, and interrupted time series studies. We included studies that evaluated the effects of taxes on the fat content in foods. Such a tax could be expressed as sales, excise, or special value added tax (VAT) on the final product or an intermediary product. Eligible interventions were taxation at any level, with no restriction on the duration or the implementation level (i.e. local, regional, national, or multinational). Eligible study populations were children (zero to 17 years) and adults (18 years or older) from any country and setting. We excluded studies that focused on specific subgroups only (e.g. people receiving pharmaceutical intervention; people undergoing a surgical intervention; ill people who are overweight or obese as a side effect, such as those with thyroiditis and depression; and people with chronic illness). Primary outcomes were total fat consumption, consumption of saturated fat, energy intake through fat, energy intake through saturated fat, total energy intake, and incidence/prevalence of overweight or obesity. We did not exclude studies based on country, setting, comparison, or population., Data Collection and Analysis: We used standard Cochrane methods for all phases of the review. Risk of bias of the included studies was assessed using the criteria of Cochrane's 'Risk of bias' tool and the EPOC Group's guidance. Results of the review are summarized narratively and the certainty of the evidence was assessed using the GRADE approach. These steps were done by two review authors, independently., Main Results: We identified 23,281 records from searching electronic databases and 1173 records from other sources, leading to a total of 24,454 records. Two studies met the criteria for inclusion in the review. Both included studies investigated the effect the Danish tax on saturated fat contained in selected food items between 2011 and 2012. Both studies used an interrupted time series design. Neither included study had a parallel control group from another geographic area. The included studies investigated an unbalanced panel of approximately 2000 households in Denmark and the sales data from a specific Danish supermarket chain (1293 stores). Therefore, the included studies did not address individual participants, and no restriction regarding age, sex, and socioeconomic characteristics were defined. We judged the overall risk of bias of the two included studies as unclear. For the outcome total consumption of fat, a reduction of 41.8 grams per week per person in a household (P < 0.001) was estimated. For the consumption of saturated fat, one study reported a reduction of 4.2% from minced beef sales, a reduction of 5.8% from cream sales, and an increase of 0.5% to sour cream sales (no measures of statistical precision were reported for these estimates). These estimates are based on a restricted number of food types and derived from sales data; they do not measure individual intake. Moreover, these estimates do not account for other relevant sources of fat intake (e.g. packaged or processed food) or other food outlets (e.g. restaurants or cafeterias); hence, we judged the evidence on the effect of taxation on total fat consumption or saturated fat consumption to be very uncertain. We did not identify evidence on the effect of the intervention on energy intake or the incidence or prevalence of overweight or obesity., Authors' Conclusions: Given the very low quality of the evidence currently available, we are unable to reliably establish whether a tax on total fat or saturated fat is effective or ineffective in reducing consumption of total fat or saturated fat. There is currently no evidence on the effect of a tax on total fat or saturated fat on total energy intake or energy intake through saturated fat or total fat, or preventing the incidence or reducing the prevalence of overweight or obesity., (Copyright © 2020 The Authors. Cochrane Database of Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration.)

Background: Experimental and observational research has suggested the potential for increased type 2 diabetes (T2D) risk among populations taking statins for the primary prevention of atherosclerotic cardiovascular disease (ASCVD). However, few studies have directly compared statin-associated benefits and harms or examined heterogeneity by population subgroups or assumed treatment effect. Thus, we compared ASCVD risk reduction and T2D incidence increases across 3 statin treatment guidelines or recommendations among adults without a history of ASCVD or T2D who were eligible for statin treatment initiation., Methods and Findings: Simulations were conducted using Markov models that integrated data from contemporary population-based studies of non-Hispanic African American and white adults aged 40-75 years with published meta-analyses. Statin treatment eligibility was determined by predicted 10-year ASCVD risk (5%, 7.5%, or 10%). We calculated the number needed to treat (NNT) to prevent one ASCVD event and the number needed to harm (NNH) to incur one incident case of T2D. The likelihood to be helped or harmed (LHH) was calculated as ratio of NNH to NNT. Heterogeneity in statin-associated benefit was examined by sex, age, and statin-associated T2D relative risk (RR) (range: 1.11-1.55). A total of 61,125,042 U.S. adults (58.5% female; 89.4% white; mean age = 54.7 years) composed our primary prevention population, among whom 13-28 million adults were eligible for statin initiation. Overall, the number of ASCVD events prevented was at least twice as large as the number of incident cases of T2D incurred (LHH range: 2.26-2.90). However, the number of T2D cases incurred surpassed the number of ASCVD events prevented when higher statin-associated T2D RRs were assumed (LHH range: 0.72-0.94). In addition, females (LHH range: 1.74-2.40) and adults aged 40-50 years (LHH range: 1.00-1.14) received lower absolute benefits of statin treatment compared with males (LHH range: 2.55-3.00) and adults aged 70-75 years (LHH range: 3.95-3.96). Projected differences in LHH by age and sex became more pronounced as statin-associated T2D RR increased, with a majority of scenarios projecting LHHs < 1 for females and adults aged 40-50 years. This study's primary limitation was uncertainty in estimates of statin-associated T2D risk, highlighting areas in which additional clinical and public health research is needed., Conclusions: Our projections suggest that females and younger adult populations shoulder the highest relative burden of statin-associated T2D risk., Competing Interests: The authors have declared that no competing interests exist.

Background: Behavioural interventions may increase social inequalities in health. This study aimed to project the equity impact of physical activity interventions that have differential effectiveness across education groups on the long-term health inequalities by education and gender among older adults in Germany., Methods: We created six intervention scenarios targeting the elderly population: Scenarios #1-#4 applied realistic intervention effects that varied by education (low, medium high). Under scenario #5, all older adults adapted the physical activity pattern of those with a high education. Under scenario #6, all increased their physical activity level to the recommended 300 min weekly. The number of incident ischemic heart disease, stroke and diabetes cases as well as deaths from all causes under each of these six intervention scenarios was simulated for males and females over a 10-year projection period using the DYNAMO-HIA tool. Results were compared against a reference-scenario with unchanged physical activity., Results: Under scenarios #1-#4, approximately 3589-5829 incident disease cases and 6248-10,320 deaths could be avoided among males over a 10-year projection period, as well as 4381-7163 disease cases and 6914-12,605 deaths among females. The highest reduction for males would be achieved under scenario #4, under which the intervention is most effective for those with a high education level. Scenario #4 realizes 2.7 and 2.4% of the prevented disease cases and deaths observed under scenario #6, while increasing inequalities between education groups. In females, the highest reduction would be achieved under scenario #3, under which the intervention is most effective amongst those with low levels of education. This scenario realizes 2.7 and 2.9% of the prevented disease cases and deaths under scenario #6, while decreasing inequalities between education groups. Under scenario #5, approximately 31,687 incident disease cases and 59,068 deaths could be prevented among males over a 10-year projection period, as well as 59,173 incident disease cases and 121,689 deaths among females. This translates to 14.4 and 22.2% of the prevented diseases cases among males and females under scenario #6, and 13.7 and 27.7% of the prevented deaths under scenario #6., Conclusions: This study shows how the overall population health impact varies depending on how the intervention-induced physical activity change differs across education groups. For decision-makers, both the assessment of health impacts overall as well as within a population is relevant as interventions with the greatest population health gain might be accompanied by an unintended increase in health inequalities.

Background: Decision-makers increasingly request rapid answers to clinical or public health questions. To save time, personnel, and financial resources, rapid reviews streamline the methodological steps of the systematic review process. We aimed to explore the validity of a rapid review approach that combines a substantially abbreviated literature search with a single-reviewer screening of abstracts and full texts using three case studies., Methods: We used a convenience sample of three ongoing Cochrane reviews as reference standards. Two reviews addressed oncological topics and one addressed a public health topic. For each of the three topics, three reviewers screened the literature independently. Our primary outcome was the change in conclusions between the rapid reviews and the respective Cochrane reviews. In case the rapid approach missed studies, we recalculated the meta-analyses for the main outcomes and asked Cochrane review authors if the new body of evidence would change their original conclusion compared with the reference standards. Additionally, we assessed the sensitivity of the rapid review approach compared with the results of the original Cochrane reviews., Results: For the two oncological topics (case studies 1 and 2), the three rapid reviews each yielded the same conclusions as the Cochrane reviews. However, the authors would have had less certainty about their conclusion in case study 2. For case study 3, the public health topic, only one of the three rapid reviews led to the same conclusion as the Cochrane review. The other two rapid reviews provided insufficient information for the authors to draw conclusions. Using the rapid review approach, the sensitivity was 100% (3 of 3) for case study 1. For case study 2, the three rapid reviews identified 40% (4 of 10), 50% (5 of 10), and 60% (6 of 10) of the included studies, respectively; for case study 3, the respective numbers were 38% (8 of 21), 43% (9 of 21), and 48% (10 of 21)., Conclusions: Within the limitations of these case studies, a rapid review approach that combines abbreviated literature searches with single-reviewer screening may be feasible for focused clinical questions. For complex public health topics, sensitivity seems to be insufficient.

Competing Interests: Conflicts of interest The author declared no conflicts of interest.

Background: Global prevalence of overweight and obesity are alarming. For tackling this public health problem, preventive public health and policy actions are urgently needed. Some countries implemented food taxes in the past and some were subsequently abolished. Some countries, such as Norway, Hungary, Denmark, Bermuda, Dominica, St. Vincent and the Grenadines, and the Navajo Nation (USA), specifically implemented taxes on unprocessed sugar and sugar-added foods. These taxes on unprocessed sugar and sugar-added foods are fiscal policy interventions, implemented to decrease their consumption and in turn reduce adverse health-related, economic and social effects associated with these food products., Objectives: To assess the effects of taxation of unprocessed sugar or sugar-added foods in the general population on the consumption of unprocessed sugar or sugar-added foods, the prevalence and incidence of overweight and obesity, and the prevalence and incidence of other diet-related health outcomes., Search Methods: We searched CENTRAL, Cochrane Database of Systematic Reviews, MEDLINE, Embase and 15 other databases and trials registers on 12 September 2019. We handsearched the reference list of all records of included studies, searched websites of international organisations and institutions, and contacted review advisory group members to identify planned, ongoing or unpublished studies., Selection Criteria: We included studies with the following populations: children (0 to 17 years) and adults (18 years or older) from any country and setting. Exclusion applied to studies with specific subgroups, such as people with any disease who were overweight or obese as a side-effect of the disease. The review included studies with taxes on or artificial increases of selling prices for unprocessed sugar or food products that contain added sugar (e.g. sweets, ice cream, confectionery, and bakery products), or both, as intervention, regardless of the taxation level or price increase. In line with Cochrane Effective Practice and Organisation of Care (EPOC) criteria, we included randomised controlled trials (RCTs), cluster-randomised controlled trials (cRCTs), non-randomised controlled trials (nRCTs), controlled before-after (CBA) studies, and interrupted time series (ITS) studies. We included controlled studies with more than one intervention or control site and ITS studies with a clearly defined intervention time and at least three data points before and three after the intervention. Our primary outcomes were consumption of unprocessed sugar or sugar-added foods, energy intake, overweight, and obesity. Our secondary outcomes were substitution and diet, expenditure, demand, and other health outcomes., Data Collection and Analysis: Two review authors independently screened all eligible records for inclusion, assessed the risk of bias, and performed data extraction.Two review authors independently assessed the certainty of the evidence using the GRADE approach., Main Results: We retrieved a total of 24,454 records. After deduplicating records, 18,767 records remained for title and abstract screening. Of 11 potentially relevant studies, we included one ITS study with 40,210 household-level observations from the Hungarian Household Budget and Living Conditions Survey. The baseline ranged from January 2008 to August 2011, the intervention was implemented on September 2011, and follow-up was until December 2012 (16 months). The intervention was a tax - the so-called 'Hungarian public health product tax' - on sugar-added foods, including selected foods exceeding a specific sugar threshold value. The intervention includes co-interventions: the taxation of sugar-sweetened beverages (SSBs) and of foods high in salt or caffeine. The study provides evidence on the effect of taxing foods exceeding a specific sugar threshold value on the consumption of sugar-added foods. After implementation of the Hungarian public health product tax, the mean consumption of taxed sugar-added foods (measured in units of kg) decreased by 4.0% (standardised mean difference (SMD) -0.040, 95% confidence interval (CI) -0.07 to -0.01; very low-certainty evidence). The study was at low risk of bias in terms of performance bias, detection bias and reporting bias, with the shape of effect pre-specified and the intervention unlikely to have any effect on data collection. The study was at unclear risk of attrition bias and at high risk in terms of other bias and the independence of the intervention. We rated the certainty of the evidence as very low for the primary and secondary outcomes. The Hungarian public health product tax included a tax on sugar-added foods but did not include a tax on unprocessed sugar. We did not find eligible studies reporting on the taxation of unprocessed sugar. No studies reported on the primary outcomes of consumption of unprocessed sugar, energy intake, overweight, and obesity. No studies reported on the secondary outcomes of substitution and diet, demand, and other health outcomes. No studies reported on differential effects across population subgroups. We could not perform meta-analyses or pool study results., Authors' Conclusions: There was very limited evidence and the certainty of the evidence was very low. Despite the reported reduction in consumption of taxed sugar-added foods, we are uncertain whether taxing unprocessed sugar or sugar-added foods has an effect on reducing their consumption and preventing obesity or other adverse health outcomes. Further robustly conducted studies are required to draw concrete conclusions on the effectiveness of taxing unprocessed sugar or sugar-added foods for reducing their consumption and preventing obesity or other adverse health outcomes., (Copyright © 2020 The Authors. Cochrane Database of Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration.)

Objectives: The aims of this study were to formulate a generic reporting checklist for healthcare-related discrete event simulation (DES) studies and to critically appraise the existing studies., Methods: Based on the principles of accessibility and generality, assessment items were derived from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR)-Society for Medical Decision Making (SMDM) Task Force reports. The resulting checklist was applied to all 211 DES studies identified in a previous review. The proportion of fulfilled checklist items served as an indicator of reporting quality. A logistic regression was conducted to investigate whether study characteristics (eg, publication before or after the publication of the ISPOR-SMDM reports) increased the likelihood of fulfilling more than the mean number of items fulfilled by the appraised DES studies., Results: An 18-item checklist was formulated covering model conceptualization, parameterization and uncertainty assessment, validation, generalizability, and stakeholder involvement. The reporting quality of the DES models fluctuated around the mean of 63.7% (SD 11.0%) over the period studied. A modest nonsignificant improvement in reporting quality was found after the publication of the ISPOR-SMDM reports (64.5% vs 62.9%). Items with the lowest performance were related to predictive validation (2.8% of studies), cross validation (8.5%), face validity assessment (26.5%), and stakeholder involvement (27.5%). Models applied to health economic evaluation (HEE), country under study, and industry sponsorship were significantly associated with the odds of achieving above-average reporting quality., Conclusions: The checklist is applicable across various model-based analyses beyond HEEs. Adherence to the ISPOR-SMDM guidelines should be improved, particularly regarding model validation., (Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

There is evidence that replacing saturated fat (SFA) with polyunsaturated fat (PUFA) lowers ischemic heart disease (IHD). In order to improve the population's diet, the World Health Organization has called for the taxation of foods that are high in SFA. We aimed to assess the potential health gains of a European fat tax by applying the SFA intake reduction that has been observed under the Danish fat tax to six other European countries. For each country, we created a fat tax scenario with a decreased SFA intake and a corresponding increase in PUFA. We compared this fat tax scenario to a reference scenario with no change in SFA intake, and to a guideline scenario with a population-wide SFA intake in line with dietary recommendations. We used DYNAMO-HIA to dynamically project the policy-attributable IHD cases of these three scenarios 10 years into the future. A fat tax would reduce prevalent IHD cases by a minimum of 500 and 300 among males and females in Denmark, respectively, up to a maximum of 5,600 and 4,000 among males and females in the UK. Thereby, the prevented IHD cases under a fat tax scenario would correspond to between 11.0% (in females in the Netherlands) and 29.5% (in females in Italy) of the prevented IHD cases under a guideline scenario, which represents the maximum preventable disease burden. Henceforth, our quantification of beneficial health impacts makes the case for the policy debate on fat taxes., Competing Interests: The authors have declared that no competing interests exist.

Aims: To conduct a meta-analysis of statin-associated type 2 diabetes mellitus (T2D) risk among randomized controlled trials (RCTs) and observational studies (OBSs), excluding studies conducted among secondary prevention populations., Methods: Studies were identified by searching PubMed (1994-present) and EMBASE (1994-present). Articles had to meet the following criteria: (1) follow-up >one year; (2) >50% of participants free of clinically diagnosed ASCVD; (3) adult participants ≥30 years old; (4) reported statin-associated T2D effect estimates; and (5) quantified precision using 95% confidence interval. Data were pooled using random-effects model., Results: We identified 23 studies (35% RCTs) of n = 4,012,555 participants. OBS participants were on average younger (mean difference = 6.2 years) and had lower mean low-density lipoprotein cholesterol (LDL-C, mean difference = 20.6 mg/dL) and mean fasting plasma glucose (mean difference = 5.2 mg/dL) compared to RCT participants. There was little evidence for publication bias (P > 0.1). However, evidence of heterogeneity was observed overall and among OBSs and RCTs (P Cochran  = <0.05). OBS designs, younger baseline mean ages, lower LDL-C concentrations, and high proportions of never or former smokers were significantly associated with increased statin-associated T2D risk., Conclusions: Potentially elevated statin-associated T2D risk in younger populations with lower LDL-C merits further investigation in light of evolving statin guidelines targeting primary prevention populations., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: Prevention aiming at smoking, alcohol consumption, and BMI could potentially bring large gains in life expectancy (LE) and health expectancy measures such as Healthy Life Years (HLY) and Life Expectancy in Good Perceived Health (LEGPH) in the European Union. However, the potential gains might differ by region., Methods: A Sullivan life table model was applied for 27 European countries to calculate the impact of alternative scenarios of lifestyle behavior on life and health expectancy. Results were then pooled over countries to present the potential gains in HLY and LEGPH for four European regions., Results: Simulations show that up to 4 years of extra health expectancy can be gained by getting all countries to the healthiest levels of lifestyle observed in EU countries. This is more than the 2 years to be gained in life expectancy. Generally, Eastern Europe has the lowest LE, HLY, and LEGPH. Even though the largest gains in LEPGH and HLY can also be made in Eastern Europe, the gap in LE, HLY, and LEGPH can only in a small part be closed by changing smoking, alcohol consumption, and BMI., Conclusion: Based on the current data, up to 4 years of good health could be gained by adopting lifestyle as seen in the best-performing countries. Only a part of the lagging health expectancy of Eastern Europe can potentially be solved by improvements in lifestyle involving smoking and BMI. Before it is definitely concluded that lifestyle policy for alcohol use is of relatively little importance compared to smoking or BMI, as our findings suggest, better data should be gathered in all European countries concerning alcohol use and the odds ratios of overconsumption of alcohol.

The International Agency for Research on Cancer considers processed meat to be carcinogenic. Further, processed meat is associated with diabetes, ischemic heart disease (IHD) and all-cause mortality. We aimed to assess health gains of four processed meat taxation scenarios in comparison to the reference and a minimum-risk-exposure-scenario. To estimate the shift in processed meat intake following respective taxes, we calculated price elasticities for processed meat. DYNAMO-HIA was used to dynamically project policy-attributable differences in the prevalence of diseases and deaths. In projection year 10, an extra 9300 males and 4500 females would be alive under the lowest tax scenario (4% tax), compared to the reference scenario. Prevalent IHD, diabetes and colorectal cancer cases in males would be 8400, 9500 and 500 lower, respectively, and there would be 4600, 7800 and 300 less cases in females. Of the respective death and disease reduction that would be achieved under the minimum-risk-exposure-scenario, the lowest tax reaches 2.84% (colorectal cancer in males) to 6.02% (diabetes in females). Under the highest tax scenario (33.3% tax), an extra 76,700 males and 37,100 females would be alive, compared to the reference scenario. Prevalent IHD, diabetes and colorectal cancer cases would be 70,800, 77,900 and 4900 lower in males and 29,900, 48,900 and 2300 lower in females, which represents 27.84% (colorectal cancer in males) to 37.76% (diabetes in females) of the maximal preventable death and disease burden. Further research needs to examine to what extent these health benefits are outweighed by a simultaneous tax-induced decrease in fish intake., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: To assess the effects of abbreviated literature searches on evidence syntheses conclusions., Study Design and Setting: We randomly selected 60 Cochrane reviews of clinical interventions and repeated literature searches using 14 abbreviated approaches (combinations of MEDLINE, Embase, CENTRAL with and without searches of reference lists). If abbreviated searches missed included studies, we recalculated meta-analyses. Cochrane authors determined whether the new evidence base would change conclusions. We assessed the noninferiority of abbreviated searches allowing for a maximum of 10% changed conclusions., Results: We conducted 840 abbreviated literature searches. Noninferiority varied based on the definition of "changed conclusion". When the reduction of the certainty of a conclusion was of concern, all abbreviated searches were inferior. Searching Embase only rendered the greatest proportion of changed conclusions (27%, 95% confidence interval [CI]: 16%-40%); combining MEDLINE, Embase, CENTRAL with searches of references lists the lowest (8%, 95% CI 3%-18%). When falsely reaching an opposite conclusion was of concern, combining one database with another or with searches of reference lists was noninferior to comprehensive searches (2%, 95% CI: 0%-9%)., Conclusion: If decision-makers are willing to accept less certainty and a small risk for opposite conclusions, some abbreviated searches are viable options for rapid evidence syntheses. Decisions demanding high certainty require comprehensive searches., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Introduction: The efficiency-frontier approach (EFA) to health economic evaluation aims to benchmark the relative efficiency of new drugs with the incremental cost-effectiveness ratios (ICERs) of non-dominated comparators. By explicitly considering any differences in health outcomes and costs, it enhances the internal reference pricing (IRP) policy that was officially endorsed by Germany as the first country worldwide in 1989. However, the EFA has been repeatedly criticized since its official endorsement in 2009. Areas covered: This perspective aims to stimulate the debate by discussing whether the main objections to the EFA are technically valid, irrespective of national contextual factors in Germany with reservations towards using cost-per-quality-adjusted life year (QALY) thresholds. Moreover, we comparatively assessed whether the objections are truly unique to the EFA or apply equally to IRP and cost-effectiveness thresholds. Expert commentary: The plethora of objections to the EFA (n = 20) has obscured that many objections are neither technically valid nor unique to the EFA. Compared with cost-effectiveness thresholds, only two objections apply uniquely to the EFA and concern intended key properties: (1) no external thresholds are needed and (2) the EFA is sensitive to price changes of comparators. Combining these policies and developing them further are under-utilized research areas.

Backround: Meta-analysis of the impact of public smoking bans on children's exposure to secondhand smoke (SHS) exposure at home., Methods: The electronic databases of PubMed, Web of Science, PsycINFo, ASSIA, CINAHL were searched. German public health journals not captured by these databases and grey literature were considered in addition. Studies were included when they reported children's SHS exposure at home in relation to smoke-free legislation by measuring exposure before and after the introduction of a public smoking ban. Studies had to provide results on exposure prevalences of children aged below 18 years. Language of publications was restricted to German and English. Details of the included studies (n = 15) were extracted by one author and checked for accuracy by a second author. Given the exposure prevalences before and after the introduction of a smoke-free legislation, a random-effects meta-analysis of relative risks (RR) was conducted. Results were presented in a forest plot., Results: Meta-analysis showed that the overall effect was a decreased exposure to SHS in the children's homes after introduction of a public smoking ban (RR = 0.72; 95% CI = 0.62-0.83). Only two of the 15 studies indicated an increased exposure. Sensitivity analyses considering the type of smoke-free legislation, children's age group and study quality did not substantially alter the result., Conclusion: The assumption of a displacement of smoking into homes with children due to smoke-free legislation in public places could not be confirmed. Additional research is needed to analyse long-term trends.

Objective: The aim of this study is to provide reliable regression-based estimates of costs associated with different type 2 diabetes complications., Research Design and Methods: We used nationwide statutory health insurance (SHI) data from 316,220 patients with type 2 diabetes. Costs for inpatient and outpatient care, pharmaceuticals, rehabilitation, and nonmedical aids and appliances were assessed in the years 2013-2015. Quarterly observations are available for each year. We estimated costs (in 2015 euro) for complications using a generalized estimating equations model with a normal distribution adjusted for age, sex, occurrence of different complications, and history of complications at baseline, 2012. Two- and threefold interactions were included in an extended model., Results: The base case model estimated total costs in the quarter of event for the example of a 60- to 69-year-old man as follows: diabetic foot €1,293, amputation €14,284, retinopathy €671, blindness €2,933, nephropathy €3,353, end-stage renal disease (ESRD) €22,691, nonfatal stroke €9,769, fatal stroke €11,176, nonfatal myocardial infarction (MI)/cardiac arrest (CA) €8,035, fatal MI/CA €8,700, nonfatal ischemic heart disease (IHD) €6,548, fatal IHD €20,942, chronic heart failure €3,912, and angina pectoris €2,695. In the subsequent quarters, costs ranged from €681 for retinopathy to €6,130 for ESRD., Conclusions: Type 2 diabetes complications have a significant impact on total health care costs in the SHI system, not only in the quarter of event but also in subsequent years. Men and women from different age-groups differ in their costs for complications. Our comprehensive estimates may support the parametrization of diabetes models and help clinicians and policy makers to quantify the economic burden of diabetes complications in the context of new prevention and treatment programs., (© 2018 by the American Diabetes Association.)

Objective: To assess whether a combination of Internet-based and postal survey methods (mixed-mode) compared to postal-only survey methods (postal-only) leads to improved response rates in a physician survey, and to compare the cost implications of the different recruitment strategies., Data Sources/study Setting: All primary care gynecologists in Bremen and Lower Saxony, Germany, were invited to participate in a cross-sectional survey from January to July 2014., Study Design: The sample was divided into two strata (A; B) depending on availability of an email address. Within each stratum, potential participants were randomly assigned to mixed-mode or postal-only group., Principal Findings: In Stratum A, the mixed-mode group had a lower response rate compared to the postal-only group (12.5 vs. 20.2 percent; RR = 0.61, 95 percent CI: 0.44-0.87). In stratum B, no significant differences were found (15.6 vs. 16.2 percent; RR = 0.95, 95 percent CI: 0.62-1.44). Total costs (in €) per valid questionnaire returned (Stratum A: 399.72 vs. 248.85; Stratum B: 496.37 vs. 455.15) and per percentage point of response (Stratum A: 1,379.02 vs. 861.02; Stratum B 1,116.82 vs. 1,024.09) were higher, whereas variable costs were lower in mixed-mode compared to the respective postal-only groups (Stratum A cost ratio: 0.47, Stratum B cost ratio: 0.71)., Conclusions: In this study, primary care gynecologists were more likely to participate by traditional postal-only than by mixed-mode survey methods that first offered an Internet option. However, the lower response rate for the mixed-mode method may be partly due to the older age structure of the responding gynecologists. Variable costs per returned questionnaire were substantially lower in mixed-mode groups and indicate the potential for cost savings if the sample population is sufficiently large., (© Health Research and Educational Trust.)

Background: Estimating input costs for Markov models in health economic evaluations requires health state-specific costing. This is a challenge in mental illnesses such as depression, as interventions are not clearly related to health states. We present a hybrid approach to health state-specific cost estimation for a German health economic evaluation of antidepressants. Methods: Costs were determined from the perspective of the community of persons insured by statutory health insurance ("SHI insuree perspective") and included costs for outpatient care, inpatient care, drugs, and psychotherapy. In an additional step, costs for rehabilitation and productivity losses were calculated from the societal perspective. We collected resource use data in a stepwise hierarchical approach using SHI claims data, where available, followed by data from clinical guidelines and expert surveys. Bottom-up and top-down costing approaches were combined. Results: Depending on the drug strategy and health state, the average input costs varied per patient per 8-week Markov cycle. The highest costs occurred for agomelatine in the health state first-line treatment (FT) ("FT relapse") with €506 from the SHI insuree perspective and €724 from the societal perspective. From both perspectives, the lowest costs (excluding placebo) were €55 for selective serotonin reuptake inhibitors in the health state "FT remission." Conclusion: To estimate costs in health economic evaluations of treatments for depression, it can be necessary to link different data sources and costing approaches systematically to meet the requirements of the decision-analytic model. As this can increase complexity, the corresponding calculations should be presented transparently. The approach presented could provide useful input for future models., Competing Interests: The authors declare no potential conflicts of interest.

Background: Type 2 diabetes mellitus (T2DM), a highly prevalent chronic disease, puts a large burden on individual health and health care systems. Computer simulation models, used to evaluate the clinical and economic effectiveness of various interventions to handle T2DM, have become a well-established tool in diabetes research. Despite the broad consensus about the general importance of validation, especially external validation, as a crucial instrument of assessing and controlling for the quality of these models, there are no systematic reviews comparing such validation of diabetes models. As a result, the main objectives of this systematic review are to identify and appraise the different approaches used for the external validation of existing models covering the development and progression of T2DM., Methods: We will perform adapted searches by applying respective search strategies to identify suitable studies from 14 electronic databases. Retrieved study records will be included or excluded based on predefined eligibility criteria as defined in this protocol. Among others, a publication filter will exclude studies published before 1995. We will run abstract and full text screenings and then extract data from all selected studies by filling in a predefined data extraction spreadsheet. We will undertake a descriptive, narrative synthesis of findings to address the study objectives. We will pay special attention to aspects of quality of these models in regard to the external validation based upon ISPOR and ADA recommendations as well as Mount Hood Challenge reports. All critical stages within the screening, data extraction and synthesis processes will be conducted by at least two authors. This protocol adheres to PRISMA and PRISMA-P standards., Discussion: The proposed systematic review will provide a broad overview of the current practice in the external validation of models with respect to T2DM incidence and progression in humans built on simulation techniques., Systematic Review Registration: PROSPERO CRD42017069983 .

Background: World Health Organisation recommends routine Human Papilloma Virus (HPV) vaccination for girls when its cost-effectiveness in the country or region has been duly considered. We therefore aimed to evaluate cost-effectiveness of HPV vaccination in Nigeria using pragmatic parameter estimates for cost and programme coverage, i.e. realistically achievable in the studied context., Methods: A microsimulation frame-work was used. The natural history for cervical cancer disease was remodelled from a previous Nigerian model-based study. Costing was based on health providers' perspective. Disability adjusted life years attributable to cervical cancer mortality served as benefit estimate. Suitable policy option was obtained by calculating the incremental costs-effectiveness ratio. Probabilistic sensitivity analysis was used to assess parameter uncertainty. One-way sensitivity analysis was used to explore the robustness of the policy recommendation to key parameters alteration. Expected value of perfect information (EVPI) was calculated to determine the expected opportunity cost associated with choosing the optimal scenario or strategy at the maximum cost-effectiveness threshold., Results: Combination of the current scenario of opportunistic screening and national HPV vaccination programme (CS + NV) was the only cost-effective and robust policy option. However, CS + NV scenario was only cost-effective so far the unit cost of HPV vaccine did not exceed $5. EVPI analysis showed that it may be worthwhile to conduct additional research to inform the decision to adopt CS + NV., Conclusions: National HPV vaccination combined with opportunist cervical cancer screening is cost-effective in Nigeria. However, adoption of this strategy should depend on its relative efficiency when compared to other competing new vaccines and health interventions.

Background: Unconditional cash transfers (UCTs; provided without obligation) for reducing poverty and vulnerabilities (e.g. orphanhood, old age or HIV infection) are a type of social protection intervention that addresses a key social determinant of health (income) in low- and middle-income countries (LMICs). The relative effectiveness of UCTs compared with conditional cash transfers (CCTs; provided so long as the recipient engages in prescribed behaviours such as using a health service or attending school) is unknown., Objectives: To assess the effects of UCTs for improving health services use and health outcomes in vulnerable children and adults in LMICs. Secondary objectives are to assess the effects of UCTs on social determinants of health and healthcare expenditure and to compare to effects of UCTs versus CCTs., Search Methods: We searched 17 electronic academic databases, including the Cochrane Public Health Group Specialised Register, the Cochrane Database of Systematic Reviews (the Cochrane Library 2017, Issue 5), MEDLINE and Embase, in May 2017. We also searched six electronic grey literature databases and websites of key organisations, handsearched key journals and included records, and sought expert advice., Selection Criteria: We included both parallel group and cluster-randomised controlled trials (RCTs), quasi-RCTs, cohort and controlled before-and-after (CBAs) studies, and interrupted time series studies of UCT interventions in children (0 to 17 years) and adults (18 years or older) in LMICs. Comparison groups received either no UCT or a smaller UCT. Our primary outcomes were any health services use or health outcome., Data Collection and Analysis: Two reviewers independently screened potentially relevant records for inclusion criteria, extracted data and assessed the risk of bias. We tried to obtain missing data from study authors if feasible. For cluster-RCTs, we generally calculated risk ratios for dichotomous outcomes from crude frequency measures in approximately correct analyses. Meta-analyses applied the inverse variance or Mantel-Haenszel method with random effects. We assessed the quality of evidence using the GRADE approach., Main Results: We included 21 studies (16 cluster-RCTs, 4 CBAs and 1 cohort study) involving 1,092,877 participants (36,068 children and 1,056,809 adults) and 31,865 households in Africa, the Americas and South-East Asia in our meta-analyses and narrative synthesis. The 17 types of UCTs we identified, including one basic universal income intervention, were pilot or established government programmes or research experiments. The cash value was equivalent to 1.3% to 53.9% of the annualised gross domestic product per capita. All studies compared a UCT with no UCT, and three studies also compared a UCT with a CCT. Most studies carried an overall high risk of bias (i.e. often selection and/or performance bias). Most studies were funded by national governments and/or international organisations.Throughout the review, we use the words 'probably' to indicate moderate-quality evidence, 'may/maybe' for low-quality evidence, and 'uncertain' for very low-quality evidence. UCTs may not have impacted the likelihood of having used any health service in the previous 1 to 12 months, when participants were followed up between 12 and 24 months into the intervention (risk ratio (RR) 1.04, 95% confidence interval (CI) 1.00 to 1.09, P = 0.07, 5 cluster-RCTs, N = 4972, I² = 2%, low-quality evidence). At one to two years, UCTs probably led to a clinically meaningful, very large reduction in the likelihood of having had any illness in the previous two weeks to three months (odds ratio (OR) 0.73, 95% CI 0.57 to 0.93, 5 cluster-RCTs, N = 8446, I² = 57%, moderate-quality evidence). Evidence from five cluster-RCTs on food security was too inconsistent to be combined in a meta-analysis, but it suggested that at 13 to 24 months' follow-up, UCTs could increase the likelihood of having been food secure over the previous month (low-quality evidence). UCTs may have increased participants' level of dietary diversity over the previous week, when assessed with the Household Dietary Diversity Score and followed up 24 months into the intervention (mean difference (MD) 0.59 food categories, 95% CI 0.18 to 1.01, 4 cluster-RCTs, N = 9347, I² = 79%, low-quality evidence). Despite several studies providing relevant evidence, the effects of UCTs on the likelihood of being moderately stunted and on the level of depression remain uncertain. No evidence was available on the effect of a UCT on the likelihood of having died. UCTs probably led to a clinically meaningful, moderate increase in the likelihood of currently attending school, when assessed at 12 to 24 months into the intervention (RR 1.06, 95% CI 1.03 to 1.09, 6 cluster-RCTs, N = 4800, I² = 0%, moderate-quality evidence). The evidence was uncertain for whether UCTs impacted livestock ownership, extreme poverty, participation in child labour, adult employment or parenting quality. Evidence from six cluster-RCTs on healthcare expenditure was too inconsistent to be combined in a meta-analysis, but it suggested that UCTs may have increased the amount of money spent on health care at 7 to 24 months into the intervention (low-quality evidence). The effects of UCTs on health equity (or unfair and remedial health inequalities) were very uncertain. We did not identify any harms from UCTs. Three cluster-RCTs compared UCTs versus CCTs with regard to the likelihood of having used any health services, the likelihood of having had any illness or the level of dietary diversity, but evidence was limited to one study per outcome and was very uncertain for all three., Authors' Conclusions: This body of evidence suggests that unconditional cash transfers (UCTs) may not impact a summary measure of health service use in children and adults in LMICs. However, UCTs probably or may improve some health outcomes (i.e. the likelihood of having had any illness, the likelihood of having been food secure, and the level of dietary diversity), one social determinant of health (i.e. the likelihood of attending school), and healthcare expenditure. The evidence on the relative effectiveness of UCTs and CCTs remains very uncertain.

Introduction: The Cochrane Collaboration aims to produce relevant and top priority evidence that responds to existing evidence gaps. Hence, research priority setting (RPS) is important to identify which potential research gaps are deemed most important. Moreover, RPS supports future health research to conform both health and health evidence needs. However, studies that are prioritising systematic review topics in public health are surprisingly rare. Therefore, to inform the research agenda of Cochrane Public Health Europe (CPHE), we introduce the protocol of a priority setting study on systematic review topics in several European countries, which is conceptualised as pilot., Methods and Analysis: We will conduct a two-round modified Delphi study in Switzerland, incorporating an anonymous web-based questionnaire, to assess which topics should be prioritised for systematic reviews in public health. In the first Delphi round public health stakeholders will suggest relevant assessment criteria and potential priority topics. In the second Delphi round the participants indicate their (dis)agreement to the aggregated results of the first round and rate the potential review topics with the predetermined criteria on a four-point Likert scale. As we invite a wide variety of stakeholders we will compare the results between the different stakeholder groups., Ethics and Dissemination: We have received ethical approval from the ethical board of the University of Bremen, Germany (principal investigation is conducted at the University of Bremen) and a certificate of non-objection from the Canton of Zurich, Switzerland (fieldwork will be conducted in Switzerland). The results of this study will be further disseminated through peer reviewed publication and will support systematic review author groups (i.a. CPHE) to improve the relevance of the groups´ future review work. Finally, the proposed priority setting study can be used as a framework by other systematic review groups when conducting a priority setting study in a different context., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Aims: New generation dual-source coronary CT (NGCCT) scanners with more than 64 slices were evaluated for patients with (known) or suspected of coronary artery disease (CAD) who are difficult to image: obese, coronary calcium score > 400, arrhythmias, previous revascularization, heart rate > 65 beats per minute, and intolerance of betablocker. A cost-effectiveness analysis of NGCCT compared with invasive coronary angiography (ICA) was performed for these difficult-to-image patients for England and Wales., Methods and Results: Five models (diagnostic decision model, four Markov models for CAD progression, stroke, radiation and general population) were integrated to estimate the cost-effectiveness of NGCCT for both suspected and known CAD populations. The lifetime costs and effects from the National Health Service perspective were estimated for three strategies: (1) patients diagnosed using ICA, (2) using NGCCT, and (3) patients diagnosed using a combination of NGCCT and, if positive, followed by ICA. In the suspected population, the strategy where patients only undergo a NGCCT is a cost-effective option at accepted cost-effectiveness thresholds. The strategy of using NGCCT in combination with ICA is the most favourable strategy for patients with known CAD. The most influential factors behind these results are the percentage of patients being misclassified (a function of both diagnostic accuracy and the prior likelihood), the complication rates of the procedures, and the cost price of a NGCCT scan., Conclusion: The use of NGCCT might be considered cost-effective in both populations since it is cost-saving compared to ICA and generates similar effects.

Background: Multiple reviews demonstrated high variability in effectiveness and cost-effectiveness outcomes among studies on breast cancer screening (BCS) programmes. No study to our knowledge has summarized the current evidence on determinants of effectiveness and cost-effectiveness of the most used BCS approaches or tried to explain differences in conclusions of systematic reviews on this topic. Based on published reviews, this systematic review aims to assess the degree of variability of determinants for (a) effectiveness and (b) cost-effectiveness of BCS programmes using mammography, clinical breast examination, breast self-examination, ultrasonography, or their combinations among the general population., Methods: We will perform a comprehensive systematic literature search in Cochrane, Scopus, Embase, and Medline (via Pubmed). The search will be supplemented with hand searching of references of the included reviews, with hand searching in the specialized journals, and by contacting prominent experts in the field. Additional search for grey literature will be conducted on the websites of international cancer associations and networks. Two trained research assistants will screen titles and abstracts of publications independently, with at least random 10% of all abstracts being also screened by the principal researcher. The full texts of the systematic reviews will then be screened independently by two authors, and disagreements will be solved by consensus. The included reviews will be grouped by publication year, outcomes, designs of original studies, and quality. Additionally, for reviews published since 2011, transparency in reporting will be assessed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist for the review on determinants of effectiveness and a modified PRISMA checklist for the review on determinants for cost-effectiveness. The study will apply the Assessing the Methodological Quality of Systematic Reviews checklist to assess the methodological quality of systematic reviews. We will report the data extracted from the systematic reviews in a systematic format. Meta-meta-analysis of extracted data will be conducted when feasible., Discussion: This systematic review of reviews will examine the degree of variability in the effectiveness and cost-effectiveness of BCS programmes., Systematic Review Registration: PROSPERO CRD42016050764 and CRD42016050765.

Introduction: The worldwide prevalence of overweight/obesity has continued to rise over the last decades. To reverse this trend, public health authorities are exploring cost-effective interventions, especially in high-income and middle-income countries. Community gardening offers a unique opportunity for individuals to enhance physical activity levels and improve their diet. However, synthesised evidence on the short-term or long-term effectiveness and on the costs of community gardening interventions to prevent overweight/obesity remains limited. Therefore, this review will investigate: (1) the effectiveness of voluntary participation in community gardening compared with no or a control intervention on overweight/obesity and associated health outcomes, (2) effects on different subgroups of populations and (3) the costs of community gardening interventions., Methods and Analysis: We will conduct a systematic review, limited to evaluations of community gardening interventions with controlled quantitative and interrupted time series designs. To identify relevant articles, we will systematically search 12 academic and 5 grey literature databases, as well as 2 trial registers and 6 websites. Articles will then be assessed for eligibility based on a predefined set of criteria. At least two independent reviewers will assess each article for relevance, before evaluating the methodological quality and potential bias of the studies. Data relevant to the objectives of this review will be extracted and cross-validated. Any disagreements will be mediated by a third reviewer. If feasible, meta-analyses of primary outcomes (overweight/obesity, physical activity, food intake, energy intake) will be conducted. We will use the Grading of Recommendations Assessment, Development and Evaluation method to assess the overall quality of evidence., Ethics and Dissemination: For this review, no ethical approval is required as we will only extract and analyse secondary data. We aim to submit the final review manuscript to an open access journal for publication and disseminate results via conferences and social media., Trial Registration Number: International Prospective Register of Systematic Reviews (PROSPERO)(CRD42017043696)., Competing Interests: Competing interests: TLH was the coinitiator of a community gardening project (CampusGarten) in 2013 funded by the Students Union of the University of Cologne, Cologne, Germany., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)