Special guidelines for preparation and quality approval of reviews in the form of reference documents in the field of occupational diseases

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1 Special guidelines for preparation and quality approval of reviews in the form of reference documents in the field of occupational diseases November 2010 (1 st July 2016: The National Board of Industrial Injuries (Arbejdsskadestyrelsen) changed name to Labour Market Insurance (AES/Arbejdsmarkedets Erhvervssikring)) The objective of preparing a reference document in the field of occupational diseases is to provide the best evidence-based answers to questions regarding possible causalities between various types of work-related exposures and the development of various types of diseases/complaints. Therefore, with a view to ensuring the highest possible targeted quality of the required scientific literature examination, the following special guidelines have been set up for preparation and quality approval of a reference document in the field of occupational diseases. 1. In connection with carrying out the project, the applicant will point to three or four external experts in the research area in question as relevant and competent reviewers. The Working Environment Research Fund (Arbejdsmiljøforskningsfonden) quality approves all reviewers and finally appoints two of those reviewers for the further process. All costs deriving from the work of the two reviewers will form part of the overall financial budget of the project, cf. the guide to application for subsidies from the Working Environment Research Fund. Budgets must be kept within an overall frame of DKK 50,000 for the reviewers work. Once the reviewers have been finally appointed by the Fund, a detailed budget for the project will be determined and approved by the Fund. 2. The reference document must be prepared according to the requirement specifications of the notice and will also, in addition to the budget, include a detailed plan for time consumption and deadlines for each phase of the project, including for the reviewing phase. 3. Within one month after receiving the applicant s first final draft, the two reviewers will prepare and deliver to the applicant their written comments on the document. 4. The subsidy recipient will write the final conclusion of the manuscript, in accordance with the comments received, and the revised work will be forwarded to the reviewers for any new comments. If needed, there may be one or more rounds of changes and comments in this conclusive part of the process. If it is not possible to reach a final agreement on the evidence basis and conclusions in connection with the conclusive evaluation of the work, such disagreement, and the specific origin of it, will appear explicitly from the final document. Any disagreement will be set out separately in the document. 5. The final document with incorporated contributions from reviewers will be delivered to the Fund within the agreed time limit for conclusion of the project. 6. The reference document will be delivered in an English version, including an exhaustive Danish summary. The summary will focus in particular on answering the most substantial, overall questions of the notice, including in particular a summary of conclusions regarding causalities between exposures and disease(s) and the respective evidence levels. 7. In connection with the assessment of the evidence, the subsidy recipient will apply the recognised evidence model seen below Guidelines for establishing a reference document on the causal relation between an occupational exposure and a disease outcome. In the event of the exceptional

2 application of any other evidence model, such a model is required to give a presentation of the evidence which is just as clear and transparent, based on equivalent principles. 8. The subsidy recipient will be under an obligation to personally present the results of the project, including the main conclusions of the reference document and the work method applied, to the Occupational Diseases Committee. Arrangements will be made with Labour Market Insurance. The presentation will in principle be made not later than two months after conclusion of the project. 9. As soon as Labour Market Insurance and the Occupational Diseases Committee have finalised their negotiations on the review, Labour Market Insurance, in connection with publishing the results of the negotiations, will also publish the reference document on their website This will also appear from any press release. 10. The subsidy recipient must hold back his/her own publication of the reference document and its results, including part results, until Labour Market Insurance has reported back to the subsidy recipient that negotiations have been concluded and that the document may be released for own publication. The time of publication/release of the document and its results, including part results, cannot be determined in detail, this depending on the course of the negotiations. 11. In connection with any own publication of the reference document and its results after release by Labour Market Insurance, the subsidy recipient must state that the document was written on the initiative of Labour Market Insurance and the Occupational Diseases Committee and that the reference document can also be found on the website of Labour Market Insurance In the event of an own publication of the reference document and its results after release by Labour Market Insurance, the Board will receive a copy of the subsidy recipient s own published versions of the review and its results. 13. The subsidy recipient and reviewers must not be members of the Occupational Diseases Committee or employees of wage-earner or employer organisations or Labour Market Insurance. Further reference is made to the current standard terms for subsidies from the Working Environment Research Fund. These standard terms also apply to the preparation of reference documents. Guidelines for establishing a reference document on the causal relation between an occupational exposure and a disease outcome Guidelines for manuscripts of reference documents The aim of establishing a reference document is to provide the best evidence-based answers to questions on the causal relations between an occupational exposure and a disease outcome. The reference document should be written in English and should be supplied with an extended popular summary. The text part of this summary will be translated to Danish. The reference document, tables and appendices will not be translated. The reference document should be written in a form, which is suitable for publication in a peerreviewed international journal. The word count of the main text should not exceed 8000 words. If the requirements outlined below (eg. text summaries of key studies) imply that the review becomes

3 too long for such a publication, some of the detailed information may be put in an appendix and only summarized in the main text. The manuscript should be organised as follows: 1. Background and delimitations of the task to specific diagnoses and exposures 2. The outcome under study - Clinical diagnosis and proxy-measures used in epidemiological studies. - Exclusions of certain conditions from the study. - Risk factors for the outcome (excluding the exposure under study). - Descriptive epidemiology, incidences and prevalences of the outcome. Preferably, literature references in this section should be to high quality reviews rather than original papers, since this introductory section is not based on a separate literature review by the authors. This section should be oriented towards problems to be discussed in subsequent sections. 3. The exposure under study - Definition of the exposure. - Measurement of the exposure. - Distribution in the general population and occupational groups. Preferably, literature references in this section should be to high quality reviews for the reasons given above. This section should be oriented towards problems to be discussed in subsequent sections. 4. Literature search - Description of search terms, databases searched, date of final search and number of references. - Description of the procedure followed to arrive at the studies that are considered in the document (inclusion and exclusion criteria and the methods used to apply them). - If the final set of references includes a large number of studies (eg. more than studies per outcome) it is recommended to include only the studies that are most informative with respect to the issue (key studies). The procedure used to get to these studies must be described and documented. - A flow-diagram of the literature selection should be included. 5. Literature review The final set of references from the literature search should be described in text and tables, study by study. The text should shortly present essential details of the study and provide the reader with a good impression of its distinguishing features, strengths and limitations, and should include evaluative comments by the authors of the reference document. More important studies are presented with more detail than less important ones. Critical comments on the individual study should be given [in square brackets] in this section. If there are more than references per outcome, only the key studies on which the conclusion is based need to be described in the text. The remaining articles should be

4 described in an independent table corresponding to the table of the more informative studies. The purpose of this selection is to move quickly to the more important studies and not having the presentation mixed up with detailed descriptions and results from less informative studies. 6. Quality assessment of a specific study In addition to systematic assessments of study quality using formal scoring systems, the quality of studies reviewers are encouraged to qualitatively assess the results of each study with respect to the likelihood that they may reflect chance, bias or confounding, and to assess the external validity of the study results. Quality should not be assessed only by a formal scoring system since there is no gold standard for the true validity of a study. 7. Other relevant data Other relevant data from human or animal, observational or experimental studies should be referred to. The assessment of plausible disease mechanisms to support a cause-effect relation may typically rest on such contributing evidence. The description of contributing evidence may rely on good reviews rather than original studies. 8. Discussion The discussion should consider the whole set of results from the studies included in the reference document, and especially consider the degree to which it may be assumed that bias or confounding could explain the overall results. The discussion should aim at clarifying the main arguments pertinent to the overall conclusion on causality based on the literature review. The discussion should deal with the diagnostic entities used in the epidemiological studies in the review compared to diagnostic criteria in clinical practice, the reliability and validity of the outcome measures used in different studies. The discussion should further deal with problems of exposure assessment relevant to the problem, including reliability and validity. Inaccuracies in diagnosis or exposure assessment should be discussed with respect to the direction and magnitude of the resulting bias of the exposure-outcome relation. Furthermore, the discussion should consider the effects of potential confounding or effect modification which was not accounted for, and the degree to which the overall results may be influenced by such uncontrolled confounding or effect modification. The different arguments relating to bias and confounding of the relation between outcome and exposure should be detailed and summed up in a manner that clearly explains and justifies the conclusion. 9. Conclusion The conclusion should start by describing the premises on which it is made. It should be a natural extension of the discussion and shortly declare the degree of evidence for a causal association between the outcome and exposure under consideration. The degree of evidence is described with a view to the classification scheme on the last page of these guidelines, but must verbally reflect the opinions of the authors in sufficient detail. However, the conclusion should be short and to the point. If it is concluded that there is strong or

5 moderate evidence of a causal exposure-effect relationship, the exposure-response pattern of this relationship should be described and if possible translated to a practically useful exposure measure. If several outcomes or exposures are included in the review, there must be a conclusion for each specific relation. 10. Abstract 11. Extended popular summary The extended summary must give an accurate account of the work and especially focus on an argued response to the questions raised in the task description. The language should be straight forward and technical terms should be avoided. The summary is aimed at informing the organisation that funded the work, decision makers and the public at large on the background, results and conclusions of the work. The extended popular summary will be translated to Danish.

6 Degree of evidence of a causal association between an exposure to a specific risk factor and a specific outcome. The following categories are used. +++ strong evidence of a causal association ++ moderate evidence of a causal association + limited evidence of a causal association 0 insufficient evidence of a causal association - evidence suggesting lack of a causal association Description of categories: Strong evidence of a causal association (+++): A causal relationship is very likely. A positive relationship between exposure to the risk factor and the outcome has been observed in several epidemiological studies. It can be ruled out with reasonable confidence that this relationship is explained by chance, bias or confounding. Moderate evidence of a causal association (++): A causal relationship is likely. A positive relationship between exposure to the risk factor and the outcome has been observed in several epidemiological studies. It cannot be ruled out with reasonable confidence that this relationship can be explained by chance, bias or confounding, although this is not a very likely explanation. Limited evidence of a causal association(+): A causal relationship is possible. A positive relationship between exposure to the risk factor and the outcome has been observed in several epidemiological studies. It is not unlikely that this relationship can be explained by chance, bias or confounding. Insufficient evidence of a causal association (0): The available studies are of insufficient quality, consistency, or statistical power to permit a conclusion regarding the presence or absence of a causal association. Evidence suggesting lack of a causal association (-): Several studies of sufficient quality, consistency and statistical power indicate that the specific risk factor is not causally related to the specific outcome. Comments: The classification does not include a category for which a causal relation is considered as established beyond any doubt. The key criterion is the epidemiological evidence. The likelihood that chance, bias and confounding may explain observed associations are criteria that encompass criteria such as consistency, number of high quality studies, types of design etc. Biological plausibility and contributory information may add to the evidence of a causal association.

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