This multi-method design study was conducted in five stages within the framework of the National Institute for Health and Care Excellence (NICE) guideline(24). This research was conducted from January2020 to June 2022. First, a research committee consisting of five members (the first author and research team) was created for performing qualitative study and searching the available reference in databases. Furthermore, 16 secondary members were added. Then 9 specialists in the Related scientific fields investigated the content validity of the clinical practice guideline. The NICE guide consists of six stages, but in this study, the last stage (updating phase) was not applicable(24).
1) The stage of determining the scope: In our study in the first stage, the scope of the study and its objectives were determined in the research committee with focal members. Then, a decision was made on the following issue: “Which clinical questions should be addressed through the clinical practice guideline of management fear of childbirth?”
2) The stage of development: this stage was performed through discussion and decision-making in the research committee for conducting a qualitative study phase involving interpreting the understanding of managing of fear of childbirth concept, the needs of pregnant women, expectations, and skills of beneficiaries in the culture context as well as a systematic review phase (scoping search). In the qualitative study phase, 40 unstructured interviews were made with the participants in the study, including pregnant women, healthcare team members, and Health policy makers through conventional content analysis method. Writing of the qualitative phase of the study was based on the COREQ (consolidated criteria for reporting qualitative research) checklist. In the next step, by a systematic review, the available evidence on the literature and existing guidelines was extracted during an extensive search in databases. The systematic review was done based on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2009. In the process of systematic review, first the research question was designed based on the study objectives through PIPOH method (Population, Intervention(s) (or diagnostic test) of interest, Professionals, Expected Outcomes, Healthcare setting and context). Through this method, the clinical question was designed as “What evidence-based interventions do health care providers and other members of the health care team use to reduce expectant mothers' fear of childbirth and promote their mental health?”. After designing the clinical question, three members (the first author and one member of the reproductive health group and finally one person with librarian expertise) searched the literature related to the topic. The search was carried out in the electronic databases, PubMed, Scopus, Embase, Web of Science, Clinical Key, Cochrane Library, and in specialized databases for guidelines, Agency for Healthcare Research and Quality & National Guideline Clearinghouse (NGC), Guideline International Network (G-I-N), National Institute for Health and Care Excellence, New Zealand Guidelines Group, National Health and Medical Research Council (NHMRC), The Scottish for Clinical Guidelines Network (SIGN), Clinical Trials.gov. At first, the title and summary of the extracted articles were independently screened by two authors according to the inclusion and exclusion criteria. In the next step, the full text of the selected articles was thoroughly studied by two authors. Eventually, 62 studies remained in the study (Fig. 1).
(Fig. 1 here)
Then, the information required for the studies was extracted and recorded in a designed form by the research team. At stage of development, the preliminary draft of the guideline was also developed in the research team through combining evidence-based recommendations from the results of the qualitative study phase and the systematic review.
3) Consultation stage: A panel group consisting of the specialists, i.e., the researchers and practitioners of the reproductive and mental health field, evaluated the draft of guidelines in terms of content validity using the nominal group technique. The specialists of the expert panel consisted of 16 scholars in the area of reproductive health and midwifery, gynecology and obstetrics, clinical psychology and psychiatry, health policy and university faculty members who had adequate skills and knowledge to comment on the studied subject, and expressed their interest to participate in the study. Based on the available sources, first the guide table of clinical components was designed in seven areas, and based on the opinions of people in each area, detailed descriptions of the relevant measures were included. Specific areas in this table include: the target group for the development of the clinical guide, the implementers of the implementation of the clinical guide, the necessary services for the development of the clinical guide (including educational services and individual and group counseling, psychological interventions and interventions related to Improving childbirth experiences), empowering the health team, improving the system of providing health services to pregnant women, social support for women suffering from fear of childbirth, forming peer groups, and monitoring indicators and evaluating the results of service implementation. Each of the areas of this table included different options that were the result of integration the results of the qualitative stage and the systematic review of articles. Based on the scores given by the panel members for each item, options were prioritized in each section. The results of prioritization were used in the compilation of recommendations related to different parts of the clinical guideline.
The clinical guide for the management of fear of childbirth was developed with the aim of designing evidence-based recommendations based on the expectations and needs of expectant mothers and health team members in the context of Iranian culture. The recommendations of the clinical guidelines for the management of fear of childbirth in pregnant women (190 recommendations) were formed in seven main areas. Subsequently, this version of the guideline was provided to 12 scholars to evaluate the guideline by the AGREE-II reporting checklist (Appraisal of Guidelines for REsearch & Evaluation-II)(25).
4) Revision stage: After critical appraisal of the descriptive comments in the research team, the necessary modifications were made. Then, the final version of the clinical practice guideline of management the fear of childbirth was produced.
5) Publication stage: Guideline recommendations are published in the first author’s Doctoral Thesis, alongside all evidence reviews, tables’ results, and methods.
6) Updating stage: The formal process for updating will begin three years after publication. When important changes are made, there will be a stakeholder consultation. The updated guideline will then be published, along with a list of changes from the previous version of it. As we were in the development stage, this stage was not included in our study.