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Abstract
Introduction
Exposure to marketing for foods high in sugar, salt, and fat is considered a key risk
factor for childhood obesity. To support efforts to limit such marketing, the World
Health Organization Regional Office for Europe has developed a nutrient profile model
(WHO NPM). Germany’s Federal Ministry of Food and Agriculture plans to use this model
in proposed new food marketing legislation, but it has not yet been tested in Germany.
The present study therefore assesses the feasibility and implications of implementing
the WHO NPM in Germany.
Methods
We applied the WHO NPM to a random sample of 660 food and beverage products across
22 product categories on the German market drawn from Open Food Facts, a publicly
available product database. We calculated the share of products permitted for marketing
to children based on the WHO NPM, both under current market conditions and for several
hypothetical reformulation scenarios. We also assessed effects of adaptations to and
practical challenges in applying the WHO NPM.
Results
The median share of products permitted for marketing to children across the model’s
22 product categories was 20% (interquartile range (IQR) 3–59%) and increased to 38%
(IQR 11–73%) with model adaptations for fruit juice and milk proposed by the German
government. With targeted reformulation (assuming a 30% reduction in fat, sugar, sodium,
and/or energy), the share of products permitted for marketing to children increased
substantially (defined as a relative increase by at least 50%) in several product
categories (including bread, processed meat, yogurt and cream, ready-made and convenience
foods, and savoury plant-based foods) but changed less in the remaining categories.
Practical challenges included the ascertainment of the
trans-fatty acid content of products, among others.
Conclusion
The application of the WHO NPM in Germany was found to be feasible. Its use in the
proposed legislation on food marketing in Germany seems likely to serve its intended
public health objective of limiting marketing in a targeted manner specifically for
less healthy products. It seems plausible that it may incentivise reformulation in
some product categories. Practical challenges could be addressed with appropriate
adaptations and procedural provisions.
Plain Language Summary
On TV, on the internet, and in other media, many advertisements for unhealthy foods
can be seen. Children who see a lot of these advertisements often eat more unhealthy
foods. They also more often have overweight or obesity than other children. The World
Health Organization (WHO) therefore recommends that governments should protect children
from such advertisements. They have developed a model to tell healthy and unhealthy
foods apart. This model can be used in laws that protect children from advertisements
for unhealthy foods. The German government wants to introduce such a law. They want
to use the WHO model, but with a few changes to make it less strict. According to
the proposed new law, only healthy foods could be advertised to children. We wanted
to find out how many foods and drinks in Germany are healthy according to the WHO
model, both with the changes Germany wants and without any changes to the model. We
looked at 22 different groups of foods and drinks, such as sweets, breakfast cereals,
milk, fruit juice, bread, and meat. For each group of food and drink, we looked at
30 products that are sold in Germany. We found that on average, one in five products
overall (20% of all products) counted as healthy according to the original model.
According to the adapted model the German government wants to use, about two in five
products (40%) count as healthy. If the food industry reduced the amount of sugar,
salt, and fat in products, more would count as healthy. We also found that both versions
of the model work quite well in Germany. We therefore think that it is likely that
the model proposed by the German government would help protect children from advertisements
for unhealthy foods.
Introduction Many questions in medical research are investigated in observational studies [1]. Much of the research into the cause of diseases relies on cohort, case-control, or cross-sectional studies. Observational studies also have a role in research into the benefits and harms of medical interventions [2]. Randomised trials cannot answer all important questions about a given intervention. For example, observational studies are more suitable to detect rare or late adverse effects of treatments, and are more likely to provide an indication of what is achieved in daily medical practice [3]. Research should be reported transparently so that readers can follow what was planned, what was done, what was found, and what conclusions were drawn. The credibility of research depends on a critical assessment by others of the strengths and weaknesses in study design, conduct, and analysis. Transparent reporting is also needed to judge whether and how results can be included in systematic reviews [4,5]. However, in published observational research important information is often missing or unclear. An analysis of epidemiological studies published in general medical and specialist journals found that the rationale behind the choice of potential confounding variables was often not reported [6]. Only few reports of case-control studies in psychiatry explained the methods used to identify cases and controls [7]. In a survey of longitudinal studies in stroke research, 17 of 49 articles (35%) did not specify the eligibility criteria [8]. Others have argued that without sufficient clarity of reporting, the benefits of research might be achieved more slowly [9], and that there is a need for guidance in reporting observational studies [10,11]. Recommendations on the reporting of research can improve reporting quality. The Consolidated Standards of Reporting Trials (CONSORT) Statement was developed in 1996 and revised 5 years later [12]. Many medical journals supported this initiative [13], which has helped to improve the quality of reports of randomised trials [14,15]. Similar initiatives have followed for other research areas—e.g., for the reporting of meta-analyses of randomised trials [16] or diagnostic studies [17]. We established a network of methodologists, researchers, and journal editors to develop recommendations for the reporting of observational research: the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement. Aims and Use of the STROBE Statement The STROBE Statement is a checklist of items that should be addressed in articles reporting on the 3 main study designs of analytical epidemiology: cohort, case-control, and cross-sectional studies. The intention is solely to provide guidance on how to report observational research well: these recommendations are not prescriptions for designing or conducting studies. Also, while clarity of reporting is a prerequisite to evaluation, the checklist is not an instrument to evaluate the quality of observational research. Here we present the STROBE Statement and explain how it was developed. In a detailed companion paper, the Explanation and Elaboration article [18–20], we justify the inclusion of the different checklist items and give methodological background and published examples of what we consider transparent reporting. We strongly recommend using the STROBE checklist in conjunction with the explanatory article, which is available freely on the Web sites of PLoS Medicine (http://www.plosmedicine.org/), Annals of Internal Medicine (http://www.annals.org/), and Epidemiology (http://www.epidem.com/). Development of the STROBE Statement We established the STROBE Initiative in 2004, obtained funding for a workshop and set up a Web site (http://www.strobe-statement.org/). We searched textbooks, bibliographic databases, reference lists, and personal files for relevant material, including previous recommendations, empirical studies of reporting and articles describing relevant methodological research. Because observational research makes use of many different study designs, we felt that the scope of STROBE had to be clearly defined early on. We decided to focus on the 3 study designs that are used most widely in analytical observational research: cohort, case-control, and cross-sectional studies. We organised a 2-day workshop in Bristol, UK, in September 2004. 23 individuals attended this meeting, including editorial staff from Annals of Internal Medicine, BMJ, Bulletin of the World Health Organization, International Journal of Epidemiology, JAMA, Preventive Medicine, and The Lancet, as well as epidemiologists, methodologists, statisticians, and practitioners from Europe and North America. Written contributions were sought from 10 other individuals who declared an interest in contributing to STROBE, but could not attend. Three working groups identified items deemed to be important to include in checklists for each type of study. A provisional list of items prepared in advance (available from our Web site) was used to facilitate discussions. The 3 draft checklists were then discussed by all participants and, where possible, items were revised to make them applicable to all three study designs. In a final plenary session, the group decided on the strategy for finalizing and disseminating the STROBE Statement. After the workshop we drafted a combined checklist including all three designs and made it available on our Web site. We invited participants and additional scientists and editors to comment on this draft checklist. We subsequently published 3 revisions on the Web site, and 2 summaries of comments received and changes made. During this process the coordinating group (i.e., the authors of the present paper) met on eight occasions for 1 or 2 days and held several telephone conferences to revise the checklist and to prepare the present paper and the Explanation and Elaboration paper [18–20]. The coordinating group invited 3 additional co-authors with methodological and editorial expertise to help write the Explanation and Elaboration paper, and sought feedback from more than 30 people, who are listed at the end of this paper. We allowed several weeks for comments on subsequent drafts of the paper and reminded collaborators about deadlines by e-mail. STROBE Components The STROBE Statement is a checklist of 22 items that we consider essential for good reporting of observational studies (Table 1). These items relate to the article's title and abstract (item 1), the introduction (items 2 and 3), methods (items 4–12), results (items 13–17) and discussion sections (items 18–21), and other information (item 22 on funding). 18 items are common to all three designs, while four (items 6, 12, 14, and 15) are design-specific, with different versions for all or part of the item. For some items (indicated by asterisks), information should be given separately for cases and controls in case-control studies, or exposed and unexposed groups in cohort and cross-sectional studies. Although presented here as a single checklist, separate checklists are available for each of the 3 study designs on the STROBE Web site. Table 1 The STROBE Statement—Checklist of Items That Should Be Addressed in Reports of Observational Studies Implications and Limitations The STROBE Statement was developed to assist authors when writing up analytical observational studies, to support editors and reviewers when considering such articles for publication, and to help readers when critically appraising published articles. We developed the checklist through an open process, taking into account the experience gained with previous initiatives, in particular CONSORT. We reviewed the relevant empirical evidence as well as methodological work, and subjected consecutive drafts to an extensive iterative process of consultation. The checklist presented here is thus based on input from a large number of individuals with diverse backgrounds and perspectives. The comprehensive explanatory article [18–20], which is intended for use alongside the checklist, also benefited greatly from this consultation process. Observational studies serve a wide range of purposes, on a continuum from the discovery of new findings to the confirmation or refutation of previous findings [18–20]. Some studies are essentially exploratory and raise interesting hypotheses. Others pursue clearly defined hypotheses in available data. In yet another type of studies, the collection of new data is planned carefully on the basis of an existing hypothesis. We believe the present checklist can be useful for all these studies, since the readers always need to know what was planned (and what was not), what was done, what was found, and what the results mean. We acknowledge that STROBE is currently limited to three main observational study designs. We would welcome extensions that adapt the checklist to other designs—e.g., case-crossover studies or ecological studies—and also to specific topic areas. Four extensions are now available for the CONSORT statement [21–24]. A first extension to STROBE is underway for gene-disease association studies: the STROBE Extension to Genetic Association studies (STREGA) initiative [25]. We ask those who aim to develop extensions of the STROBE Statement to contact the coordinating group first to avoid duplication of effort. The STROBE Statement should not be interpreted as an attempt to prescribe the reporting of observational research in a rigid format. The checklist items should be addressed in sufficient detail and with clarity somewhere in an article, but the order and format for presenting information depends on author preferences, journal style, and the traditions of the research field. For instance, we discuss the reporting of results under a number of separate items, while recognizing that authors might address several items within a single section of text or in a table. Also, item 22, on the source of funding and the role of funders, could be addressed in an appendix or in the methods section of the article. We do not aim at standardising reporting. Authors of randomised clinical trials were asked by an editor of a specialist medical journal to “CONSORT” their manuscripts on submission [26]. We believe that manuscripts should not be “STROBEd”, in the sense of regulating style or terminology. We encourage authors to use narrative elements, including the description of illustrative cases, to complement the essential information about their study, and to make their articles an interesting read [27]. We emphasise that the STROBE Statement was not developed as a tool for assessing the quality of published observational research. Such instruments have been developed by other groups and were the subject of a recent systematic review [28]. In the Explanation and Elaboration paper, we used several examples of good reporting from studies whose results were not confirmed in further research – the important feature was the good reporting, not whether the research was of good quality. However, if STROBE is adopted by authors and journals, issues such as confounding, bias, and generalisability could become more transparent, which might help temper the over-enthusiastic reporting of new findings in the scientific community and popular media [29], and improve the methodology of studies in the long term. Better reporting may also help to have more informed decisions about when new studies are needed, and what they should address. We did not undertake a comprehensive systematic review for each of the checklist items and sub-items, or do our own research to fill gaps in the evidence base. Further, although no one was excluded from the process, the composition of the group of contributors was influenced by existing networks and was not representative in terms of geography (it was dominated by contributors from Europe and North America) and probably was not representative in terms of research interests and disciplines. We stress that STROBE and other recommendations on the reporting of research should be seen as evolving documents that require continual assessment, refinement, and, if necessary, change. We welcome suggestions for the further dissemination of STROBE—e.g., by re-publication of the present article in specialist journals and in journals published in other languages. Groups or individuals who intend to translate the checklist to other languages should consult the coordinating group beforehand. We will revise the checklist in the future, taking into account comments, criticism, new evidence, and experience from its use. We invite readers to submit their comments via the STROBE Web site (http://www.strobe-statement.org/).
Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalizability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control and cross-sectional studies. We convened a two-day workshop, in September 2004, with methodologists, researchers and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the web sites of PLoS Medicine, Annals of Internal Medicine and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.
Background Concerns have been raised about the quality of reporting in nutritional epidemiology. Research reporting guidelines such as the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement can improve quality of reporting in observational studies. Herein, we propose recommendations for reporting nutritional epidemiology and dietary assessment research by extending the STROBE statement into Strengthening the Reporting of Observational Studies in Epidemiology—Nutritional Epidemiology (STROBE-nut). Methods and Findings Recommendations for the reporting of nutritional epidemiology and dietary assessment research were developed following a systematic and consultative process, coordinated by a multidisciplinary group of 21 experts. Consensus on reporting guidelines was reached through a three-round Delphi consultation process with 53 external experts. In total, 24 recommendations for nutritional epidemiology were added to the STROBE checklist. Conclusion When used appropriately, reporting guidelines for nutritional epidemiology can contribute to improve reporting of observational studies with a focus on diet and health.
This article is licensed under the Creative Commons Attribution-NonCommercial 4.0
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History
Date
received
: 19
May
2023
Date
accepted
: 5
October
2023
Date: 2024
Page count
Figures: 5,
Tables: 0,
References: 29,
Pages: 12
Funding
This work was conducted without external funding through staff positions at Ludwig-Maximilians-Universität
München (LMU Munich), Germany, and the German Obesity Society (DAG), Berlin, Germany.
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