Table 1

Appraisal of the processes and methods used in the recommendations for vitamin D and calcium in public health guidelines

Process and method domainsProcess and method criteriaDescriptionExamples where to look
I. Guideline development group (GDG, including members of steering group, research team and individuals involved formulating the final recommendations)
Were each of the following considered in the formation of the guideline development group?1. Discipline representationInformation about the composition, discipline and relevant expertise of the guideline development group should be provided. Information can be located in methods, guideline panel member list, acknowledgements and appendices.
2. Diversity representationInformation about gender, diversity, across the life-course, subject to different gender norms and belonging to different income and education groups of the guideline development group.
3. Stakeholder inputStakeholders such as non-governmental organisations, advocacy groups, funders, target audiences and service-users may be invited to ensure transparency of the process and facilitate implementation.
II. Conflicts of interest
Were each of the following steps addressed regarding conflicts of interest?4. Disclosure of conflicts of interest obtained (extract verbatim text of COI for each member).Is there an explicit statement that all group members have declared whether they have any competing interests? Paragraphs/chapters describing the guideline development group or acknowledgements section in methods, conflicts of interest, guideline panel and appendix.
5. Conflicts of interest managed.Members declaration of interests must be reported to the steering group. Potential candidates for membership who have major conflicts of interest, be they financial or nonfinancial, cannot be appointed to the GDG. Minor conflicts of interest can be managed at the individual level (eg, by restricting participation in parts of the GDG meeting) or at the group level.
6. Disclosure of funders of the guideline obtained and disclose funder’s role in influencing the guideline development process and recommendations.Is there an explicit statement of funder of the guideline and the role of funders in the final guideline recommendations?
III. Systematic review methods
Were methods for each of the following addressed in the guideline?7. Formulation of key questions for the evidence review in PICO, PICOT or PEO format (also extract the key questions in such format).Key questions are framed in a way that enables a systematic search of the literature and delineates inclusion and exclusion criteria for the body of evidence to formulate the research questions for the recommendations in such format. Examine the paragraphs/chapters describing the guideline development process in methods, literature search strategy and appendices.
8. Choosing (finalising) priority outcomes for systematic review.List high-priority key questions and the outcomes to formulate recommendations.
9. Systematic methods to search for evidence.Details of the strategy used to search for evidence should be provided including search terms used, sources consulted and dates of the literature covered. Sources may include electronic databases, hand searching journals, reviewing conference proceedings and other guidelines.
10. Evidence retrieval (screening and selection of eligible studies).Process of data from eligible studies are extracted and search strategy and results should be carefully documented.
11. Evidence quality assessment.Each study included in a systematic review should be assessed for risk of bias (eg, use the Cochrane risk of bias tool, quality assessment tolls project report and so on).
12. Evidence synthesisThe findings of the systematic review may be synthesised in a narrative manner or quantitatively in a meta-analysis. The review should describe how data were handled and why a given approach to synthesis was taken for each outcome.
IV. Transparency of evidence supporting the recommendations
If evidence was explicitly linked to recommendation, what type of evidence was reported?13. Are recommendations explicitly linked to substantiating evidence?An explicit link between the recommendations and the evidence on which they are based should be included in the guideline. The guideline user should be able to identify the components of the body of evidence relevant to each recommendation. Define and examine the recommendations in the guideline and the text describing the body of evidence that underpins them. Examples of commonly labelled sections or chapters in a guideline where this information can be found include: recommendations and key evidence.
 a. Primary research.Primary individual studies.
b. Systematic reviews.Systematic reviews of clinical trials/observational studies.
c. Summary table of the evidenceSummary of evidence table.
d. GRADE evidence profilesGRADE summary of evidence table.
e. Evidence to decision table
f. If evidence is explicitly linked to recommendation, what is the citation information, if applicable?List the citations of the studies underlying the recommendations.
V. Recommendation development: factors that determine the direction and strength of a recommendation
Was each of the following items considered when developing the recommendation?
(also communicate with guideline authority whether other documentation may provide such information if they cannot be located in the main guideline reports).
14. Was a consensus process clearly described for developing recommendations.A description of the methods used to formulate the recommendations and how final decisions were arrived at should be provided. For example, methods may include a voting system, informal consensus and formal consensus techniques. Areas of disagreement and methods of resolving them should be specified. Examples of commonly labelled sections or chapters in a guideline where this information can be found include methods and guideline development process or in appendices.
15. Was a method employed to determine strength and/or certainty of the recommendation?Is there a method provided to influence the direction and strength of a recommendation (eg, use GRADE framework and others).
16. Priority of the problem: Is the problem a burden of disease?The problem’s priority is determined by its importance and frequency (ie, burden of disease, disease prevalence or baseline risk). The greater the importance of the problem, the greater the likelihood of a strong recommendation.
17. Quality of the evidence: Is higher quality of the body of evidence included to support the recommendation?Is there a method provided to grade the quality of body of evidence to assess the strength of the recommendation (eg, GRADE and others).
18. Certainty of evidence: Does the recommendation include consistent body of evidence (eg, confidence in effect estimates)?The quality of the evidence—the degree of confidence in the estimates of effect. This is a key factor in determining the strength of a recommendation.
19. Benefits and harms: Are evaluations performed on the net benefit or net harm associate with an intervention or exposure?The balance between an intervention’s or exposure’s benefits and harms. Did the guideline development group consider the magnitude of the effects and the relative importance of the outcomes, including any disadvantages or inconveniences associated with the intervention.
20. Balance: Does the balance between desirable and undesirable effects support the recommendation?Does the balance between desirable and undesirable effects favour the intervention or the comparison?
21. Outcome importance: Is there important uncertainty about or variability in how much people value the main outcome?Is there important uncertainty about or variability in how much people value the main outcomes, including adverse effects and burden of the test and downstream outcomes of clinical management that is guided by the test results?
22. Equity: Does the evidence used reduce inequalities, improve equity or contribute to the realisation of one of several human rights defined under the international legal framework?What would be the impact on health equity?
23. Acceptability: Is the option acceptable to key stakeholders?A strategy to address concerns about acceptability during implementation will be included in the guideline with the recommendations. Acceptability is affected by several factors, such as who benefits from an intervention and who is harmed by it; who pays for it or saves money on account of it; and when the benefits, harms and costs occur.
24. Feasibility: Is the option feasible to implement?Feasibility is influenced by the resources available, programmatic considerations, the existing and the necessary infrastructure and training and so on.
VI. Peer review process
25. Was the guideline/recommendation reviewed by an external review group?Is there an explicit statement about the peer review of the draft final guideline? The external review group is composed of persons interested in the subject of the guideline as well as individuals who will be affected by the recommendations.Information can be located in methods, guideline panel member list, acknowledgements and appendices.
  • GRADE, Grading of Recommendations, Assessment, Development and Evaluations.