This document represents WHO's normative support for using evidence-informed policies and practices in all countries. This guideline forms part of a WHO knowledgeto- action project entitled GREAT (Guideline development, Research priorities, Evidence synthesis, Applicability of evidence, Transfer of knowledge) (12) and was developed using standardized operating procedures in accordance with the process described in the WHO handbook for guideline development (13). In summary, the process included: (i) identification of priority questions and critical outcomes, (ii) retrieval of the evidence, (iii) assessment and synthesis of the evidence, (iv) formulation of recommendations, and (v) planning for the dissemination, implementation, impact evaluation and updating of the guideline.
First, a Guideline Steering Group was constituted with WHO staff from the Department of Reproductive Health and Research (RHR) and the Department of Maternal, Newborn, Child and Adolescent Health (MCA). This group drafted a list of questions and outcomes related to augmentation of labour. Then WHO consulted a large group of international stakeholders including midwives, obstetricians, neonatologists, researchers, experts in research synthesis, experts in health care programmes, and consumer representatives to review and prioritize the draft questions and outcomes. From this pool of stakeholders, a Guideline Development Group (GDG) and an External Review Group were set up to support the guideline development process. The GDG was made up of external experts whose tasks were to provide advice on the guideline development process, appraise the evidence used to inform the guidelines, advise on the interpretation of this evidence, and formulate the final recommendations. The main role of the External Review Group was to review and comment on the finalized guideline document. The members of the Guideline Steering Group and the External Review Group are listed in Annex 1.
The large group of international stakeholders rated the questions and outcomes, which had been drafted by the Guideline Steering Group, on a scale from one to nine. In this context, a question or outcome was defined as “critical” if it was given an average score of seven or more. Questions and outcomes with a score of between four and six were considered “important but not critical”, while those with a score lower than four were not considered to be important for the purposes of the guideline. The lists of critical and important outcomes are provided in Annex 2. The prioritized questions and the outcomes rated as critical were included in the scope of this document for evidence searching, retrieval, grading and formulation of recommendations. In situations where critical outcomes were poorly reported in a systematic review, “important but not critical” outcomes were used to complement the evidence base for the recommendations.
Cochrane systematic reviews of randomized controlled trials (RCTs) were the primary source of evidence for the recommendations.1 Using the assembled lists of questions and outcomes, the Guideline Steering Group along with an external team of guideline methodologists (who were also members of the GDG) reviewed the scientific evidence, prepared the evidence profiles, and drafted the narrative summaries of evidence used in this guideline. First, they identified Cochrane systematic reviews that were either relevant or potentially relevant and then assessed whether they needed to be updated. A review was considered to be outdated if the last specified date for new trial searches was two years ago or more, or if there were relevant trials still awaiting assessment, as identified by the standard search procedures of the Cochrane Pregnancy and Childbirth Group. Updates were performed using standard search strategies. For reviews found to be outdated, the contact authors of such reviews were requested to update them within a specified time period. In instances in which the contact authors were unable to do so, the updates were undertaken by the external team of methodologists in consultation with the Guideline Steering Group. The search strategies employed to identify the trials and the specific criteria for trial inclusion and exclusion are described in the individual systematic reviews.
The following procedures were used to extract the evidence for this guideline from each of these systematic reviews: first, the most up-to-date version of the Review Manager (RevMan) file was obtained from the Cochrane Pregnancy and Childbirth Group and customized to reflect the key comparisons and outcomes (excluding those that were not relevant to the guideline). Then the RevMan file was exported to the GRADE profiler software (Grading of Recommendations Assessment, Development and Evaluation) and the GRADE criteria were applied to critically appraise the retrieved scientific evidence. Finally, evidence profiles (in the form of GRADE tables) were prepared for each comparison. This process was managed through an online collaborative process between the WHO Guideline Steering Group and the external team of guideline methodologists.
The evidence presented in the GRADE tables was derived from a large body of data extracted primarily from Cochrane reviews, which in many cases contained multiple comparisons. Each GRADE table relates to one specific question or comparison, but some GRADE tables do not contain data for all critical outcomes. This is because data for those outcomes were not available in the Cochrane reviews. The raw data that formed the basis of the GRADE tables are not included in this document, but can be made available to readers interested in how these GRADE tables were constructed. The Guideline Steering Group used the information presented in the GRADE tables to draft recommendations related to each question. Each recommendation was allocated to a thematic module, which included the narrative summaries of evidence and the relevant GRADE tables. The standardized criteria used in grading the evidence and the thematic modules (including the GRADE tables themselves) are not included in this document. They have been published separately in a document entitled WHO recommendations for augmentation of labour: evidence base.2
A preliminary online consultation was held to review the draft recommendations. The draft recommendations and supporting evidence were made available to the members of the GDG and they were asked to comment on the document in tracked mode. Members of the GDG and additional experts from WHO regional offices were then invited to attend the WHO technical consultation on augmentation of labour, held at WHO headquarters in Geneva, Switzerland, on 26–27 September 2013 (see Annex 1 for a full list of participants). The draft recommendations, the narrative summaries of evidence, the GRADE tables for the recommendations, and other related documents were provided to participants in advance. Balance worksheets were used during the technical consultation to summarize the values, preferences and judgements made about the strength of recommendations (see Annex 3, Boxes 1–4 for the summary of considerations relating to the strength of all recommendations, and Box 5 for the explanations underlying the use of the balance worksheets).
2.1. Declaration of interests by participants at the WHO technical consultation
According to WHO regulations, all experts serving in an advisory role must declare their relevant interests prior to participation in WHO meetings. All GDG members and other participants were therefore required to complete a Declaration of Interest form before the technical consultation. The Guideline Steering Group reviewed the group's declarations before invitations were finalized. The GDG members were also asked to verbally declare potential conflicts of interest at the beginning of the meeting. The procedures for the management of conflicts of interest were undertaken in accordance with the WHO guidelines for declaration of interests (WHO experts). In summary, all members of the GDG declared that they had no academic, commercial or financial interests that were directly or indirectly related to the subject to be discussed at the meeting. Full participation of all the selected experts was deemed appropriate.
2.2. Decision-making during the technical consultation
The technical consultation process was guided by the following protocol: the meeting was designed to allow participants to discuss each of the recommendations drafted by the Guideline Steering Group. Where necessary, each of these recommendations was revised through group discussion. The final adoption of each recommendation was made by consensus – defined as the agreement by at least three quarters of the participants – provided that those who disagreed did not feel strongly about their position. Strong disagreements would have been noted as such in the final guideline, if such events were recorded. When the participants were unable to reach a consensus, the disputed recommendation, or any other decision, was put to a vote. A recommendation or decision stood if a simple majority (more than half of the participants) voted in support of it, unless the disagreement was related to a safety concern, in which case the WHO Secretariat might decide not to issue a recommendation at all. WHO staff, the external methodologists and the observers at the meeting were not eligible to vote. If the issue to be voted upon involved primary research or systematic reviews conducted by any of the participants who had declared an academic conflict of interest, the participants in question would be allowed to participate in the discussion, but would not be allowed to vote on that particular issue.
The participants at the technical consultation also determined the strength of each recommendation. By default, the strength of each recommendation was aligned initially with the quality of the evidence, such that, at the start of the discussion, strong recommendations were based on evidence that was considered to be of moderate and high quality, while weak recommendations were based on evidence that had been graded as low and very low quality. In addition to evaluating the scientific evidence and its quality, the following factors were also considered when determining the strength and direction of the final recommendation: values and preferences, the magnitude of effect, the balance of benefits versus harms, resource use and feasibility (14). Values and preferences, resource use, and the feasibility of each recommendation were based on the experience and opinions of the GDG members. Balance worksheets were used to note and synthesize these considerations and to record the reasons for changes made to the default strength of the recommendations (see Annex 3). In general, a high quality, strong recommendation indicates that further research on the particular question is not considered to be a priority.
2.3. Document preparation and peer review
Prior to the technical consultation, the Guideline Steering Group prepared a preliminary version of this document using a guideline reporting template that had been developed as part of WHO's GREAT project (12). The draft guideline was made available to the invited participants one week before the meeting for their comments. During the meeting, the draft recommendations were modified in line with participants' deliberation and comments. Feedback received during the preliminary online consultation was also discussed and incorporated into the document where appropriate. After the meeting, members of the Guideline Steering Group worked to ensure that a revised version of the document accurately reflected the deliberations and decisions of the meeting participants. The revised draft guideline document was sent to the members of External Review Group and their inputs were carefully evaluated by the Guideline Steering Group for inclusion in the revised document. After the technical consultation, the Guideline Steering Group refrained from making substantive changes to the guideline scoping (such as the further expansion of the guideline scoping) or to the recommendations. The revised version was returned electronically to those who had participated in the technical consultation for their final approval.
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As part of the Cochrane prepublication editorial process, reviews are commented on by three peers (one editor and two referees external to the editorial team) and the Cochrane review group's statistical adviser. The Cochrane Handbook for Systematic Reviews of Interventions describes in detail the process of preparing and maintaining Cochrane systematic reviews on the effects of health care interventions; it is available online at http://handbook.cochrane.org/.
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