Contributors to the guideline

Identifying critical outcomes

The critical and important outcomes were aligned with the Sustainable Development Goals. These outcomes were initially identified through a search of key sources of relevant published systematic reviews and setting priorities among outcomes by the Guideline Development Group panel that took place during the first online Guideline Development Group meeting. All the outcomes were included in the scope of this publication for evidence searching, retrieval, grading and formulation of the recommendation. Annex 1 lists the priority questions and the critical and important outcomes considered in this guideline.

Identifying and retrieving evidence

Several systematic reviews were conducted to answer the questions and were the primary source of evidence for these recommendations. These included reviews on (1) evidence related to the presence of Zika virus in breast-milk and transmission through breast-milk to help to inform global guidelines on infant feeding; (2) a systematic review of modified feeding practices and additional primary caregiver support to improve outcomes among infants 0–12 months old exposed to Zika virus or diagnosed with congenital Zika syndrome; and two qualitative evidence synthesis reviews of the values and preferences of pregnant women, mothers, family members, health-care practitioners, policy-makers and health-care providers (midwives) concerning feeding when there is a risk of mother-to-child transmission of (3) Zika virus; and (4) infectious diseases (other than HIV) to an infant (0–12 months old) or toddler (1–2 years old).

Formulating recommendations

The WHO Guideline Steering Committee used the evidence profiles to summarize the evidence from the systematic reviews. The evidence summary and corresponding GRADE tables and GRADE-CERQual evidence profiles along with other related documents for assessing values and preferences, resource requirements, cost–effectiveness, acceptability, feasibility and equity were provided in advance to Guideline Development Group members before the second online meeting. They were invited to submit comments electronically before the meeting using the online tool QuestionPro®.

The discussion points around each of the key questions are presented, covering the following contents:

• summary of the evidence from systematic reviews for each of the interventions; and
• summary of considerations for determining the direction and strength of the recommendations, which includes:

  • the certainty of the evidence;
  • the balance of benefits and harm;
  • values and preferences (of pregnant women and mothers);
  • acceptability (to health-care workers and lay or peer counsellors);
  • resource implications;
  • equity; and
  • feasibility.
• At the end of each section, a short summary brings together:

  • the recommendation;
  • the rationale;
  • additional remarks to be considered in implementing the recommendations.

The Guideline Development Group agreed on three options for the types of recommendations:

• recommended;
• context-specific recommendation (recommended only in specific contexts); and
• not recommended.

In this framework, the size of the effect is judged as important, less important, or not important. This decision is a judgement call and focuses on the importance to the end-users (decision-makers, health-care providers, health service users and end-beneficiaries) rather than on statistical significance.

The Guideline Development Group members and other participants were then invited to attend the second online Guideline Development Group meeting. Guideline Development Group members reviewed and discussed the balance between the desirable and undesirable effects of the intervention and the overall certainty of supporting evidence, values and preferences of stakeholders, resource requirements and cost–effectiveness, acceptability, feasibility and equity, before finalizing the recommendations and remarks by unanimous consensus.

Managing conflicts of interest

WHO, in compliance with the WHO guidelines for declaration of interests for WHO experts (46) and in collaboration with the Department of Compliance and Risk Management and Ethics, managed the potential conflicts of interest. All potential members of the Guideline Development Group were asked to fill in and sign the standard WHO declaration of interests and confidentiality undertaking forms. Updated curricula vitae were also required from the prospective members of the Guideline Development Group, since they engage in their individual capacity and not as institutional representatives.

The WHO Guideline Steering Committee reviewed the declaration-of-interest statements in conjunction with the curricula vitae for all Guideline Development Group members. Information from the Internet or media was gathered to identify any public statements made or positions held by the prospective Guideline Development Group members and experts on breastfeeding counselling. These were assessed for intellectual bias that may be perceived to or actually affect impartiality. All concerns or potential issues were discussed with the WHO Office of Compliance, Risk Management and Ethics. All potential conflicts of interest were managed on a case-by-case basis.

To strengthen public trust and transparency in connection with this guideline, the names and brief biographies of individual members of the Guideline Development Group for this guideline were published in the WHO website two weeks before each meeting to allow time for “public notice and comment”.

The following members of the Guideline Development Group declared interests that were further discussed with the Office of Compliance, Risk Management and Ethics. They were assessed to merit full participation in the meeting after publicly disclosing their interests at the start of the meeting to all meeting participants and in the guideline publication. They fully participated in discussions and were included in all decision-making processes. Aside from their research and programme experiences and sources of funding, they were asked to specifically declare the following.

J.P. Dadhich declared that he owns and is paid for by the Breastfeeding Promotion Network of India. This association has worked in the field of infant nutrition and other related issues in India since 1992 in various programmes and activities. This declared interest was discussed with the Office of Compliance, Risk Management and Ethics and it was decided to allow him to fully participate in the meeting after publicly disclosing his participation in the Breastfeeding Promotion Network of India during presentations in the Guideline Development Group meeting.

All other Guideline Development Group members declared no conflicts of interest.

Decision-making process

During the meeting, the Guideline Development Group reviewed and discussed the evidence summary and reviewed the preliminary judgements and comments posted by all members in the online form. In addition to evaluating the balance between the desirable and undesirable effects of the intervention and the overall certainty of the evidence, the Guideline Development Group applied additional criteria based on the GRADE evidence-to-decision framework (47) to determine the direction and strength of the recommendations. These criteria included stakeholders’ values, resource implications, acceptability, feasibility and equity. Considerations were based on the experience and opinions of members of the Guideline Development Group and supported by evidence from a literature search when available. Evidence-to-decision tables were used to describe and synthesize these considerations.

The final decisions were made using the online tool. All members were invited to revisit the wording of the draft recommendations. No member expressed opposition to the recommendations. There was unanimous consensus.

Document preparation

Before the online meeting, the WHO Guideline Steering Committee prepared a draft version of GRADE evidence profiles, GRADE-CERQual evidence profiles, the evidence summary and other documents relevant to the Guideline Development Group deliberations. The draft documents were made available to participants two weeks before the meeting for their comments. Questions were posted online for all members to write in the judgement of the different sections included in the evidence-to-decision framework. During the meeting, these documents were discussed and comments were taken into account to modify the documents. Following the meeting, the questions were revised and all members were invited to deliberate and reach consensus.

Peer review

A preliminary version of the final document was sent for peer review to five external independent experts who were not involved in the Guideline Development Group (Annex 7). The peer reviewers did not participate in any decision-making process. The name and affiliations of peer reviewers are provided as an acknowledgement and by no means indicate their endorsement of the recommendations in this guideline. The acknowledgement of the peer reviewers does not necessarily represent the views, decisions or policies of the institutions with which they are affiliated. The WHO Guideline Steering Committee evaluated the inputs of the peer reviewers for inclusion in this document. After the meeting and external peer review, the modifications made by the WHO Guideline Steering Committee to the document consisted only of correcting factual errors and improving language to address any lack of clarity.