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Non-Clinical Interventions to reduce overall cesarean sections

- Methods

The GDG followed the GRADE-Adolopment methodology to develop this guideline (6)

1)  Topic prioritization and need for a guideline: has been decided by the Supreme Health Council based on the importance of the topic and the potential impact of the guideline when implemented.

2)  The intention of the guideline is to improve practice and to change health policies. The target audience and scope of the document were explicitly defined at the outset.

3)  Setting up the guideline development group. All members signed a COI statement.

4)  Identification and assessment of existing guidelines: The GDG screened potentially relevant guidelines. The development group assessed the relevance, timeliness, and quality of these reports. The GDG identified only one comprehensive, high-quality, and up-to-date guideline (6).

5)  The identified guideline Assessment of the methodological quality of the guideline using the AGREE GRS instrument (11). AGREE GRS includes:

i)  Overall quality of guideline development methods

ii)  Overall quality of guideline presentation

iii)  Completeness of reporting

iv)  Overall quality of guideline recommendations

v)   Overall assessment of the guideline

b)   Adaptability assessment: The GDG assessed the adaptability of the original document. Among the adaptability assessment, the GDG focused on the evidence profiles, the evidence to decision tables, and the inclusion of the pre-specified critical outcomes.

c)  Decision: After the guideline assessment, the GDG decided to adapt the original document, taking into consideration the resources required for the process.

d)  Evidence profiles

i)  The GRADE approach (GRADEpro GDT) was used to create the evidence profiles. This process involved two main steps: (1) the evaluation of the certainty of the evidence and (2) the summary of findings tables.

ii)  For guideline panels, the certainty of evidence reflects “the extent to which the confidence in an estimate of the effect is adequate to support a particular recommendation”. When assessing this item, the GDG evaluated the study design, the consistency of the results across the studies, the precision of the results, the directness of the evidence, the likelihood of publication bias, and the magnitude of the effect. The certainty of evidence is categorized as high, moderate, low, or very low.

iii) The second step consists of the summary of findings table. This chart shows the results of the studies, using both relative and absolute measures, indicating the total number of patients in each group, the total number of events, an estimate of the control group risk, the effect size, and the certainty of evidence for each outcome.

e) Evidence to decision tables: The chair of the GDG presented the evidence profiles and the EtD tables in the face-to-face meeting and the group discussed the final recommendations. The GDG determined the direction and strength of the final recommendations using the GRADE methodology, based on four key factors presented in the evidence profiles and EtD tables: the balance between benefits and harms, certainty of evidence, patients' preferences and values, and resources considerations (including equity and feasibility). The panel decided the final redaction of the recommendations.

f) Final draft: The GDG collaborated in writing the final draft of the clinical guideline.

g) External revision: The guideline underwent peer review before final publication. Experts that are not in the development group performed the external revision.