The process for developing the guideline adheres to the WHO handbook for guideline development [12] and the systematic approach outlined in Guidelines 2.0, which provides a comprehensive checklist for effective guideline development [13]. Recommendations and evidence grading are based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system [14]. The drafting of the guidelines follows the Reporting Items for Practice Guidelines in Healthcare (RIGHT) [15] and is evaluated using the Appraisal of Guidelines for Research and Evaluation (AGREE II) tool [16]. This study runs from April 2024 to January 2026, with the steps and timeline depicted in the Gantt chart (Fig. 1).
Gantt chart illustrating the essential phases and timeline for the development of the guideline
The study will be conducted at one of the central prisons in Iran, where data will be gathered from healthcare staff, pregnant inmates, and medical records to identify the specific needs and challenges related to pregnancy care in the prison setting.
As aforementioned, this study will follow the World Health Organization (WHO) Handbook for Guideline Development to create clinical guidelines for pregnancy management in prisons. The process includes: (1) forming a multidisciplinary team, (2) identifying and prioritizing key issues, (3) conducting a systematic review to gather evidence, (4) evaluating the evidence using the GRADE system, (5) formulating practical recommendations, and (6) presenting the draft recommendations to stakeholders for feedback and refinement, (7) finalizing the recommendations based on the feedback received, which will be elaborated in detail.
Setting up a multidisciplinary guideline development group
The Guideline Development Group is essential for the creation of clinical recommendations for managing pregnancy. This group comprises various specialized committees to ensure the comprehensiveness and feasibility of the guidelines.
Organizational structure of the group
The guideline development group consists of:
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Guideline steering committee: Oversees the overall process and ensures adherence to the project timeline and objectives.
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Guideline consensus expert group: Composed of healthcare professionals, including:
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Physicians: Knowledgeable Specialists in pregnancy-related health issues.
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Midwives: Experts in maternal and neonatal care.
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Public health experts: Contributors to evidence-based recommendations on public health principles.
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Guideline evidence evaluation group: Responsible for evaluating the quality of evidence and integrating it into the guidelines.
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Guideline external review group: Provides independent feedback and assessments to enhance the guideline’s credibility.
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Guideline conflict of interest management committee: Manages and declares any conflicts of interest to maintain transparency and integrity throughout the process.
Scope of the guideline
This guideline is designed to address the management of pregnancy in prison settings, emphasizing the specific health concerns of pregnant women who are incarcerated. It is aimed at healthcare providers including midwives, obstetricians, and public health professionals, operating within correctional facilities. The primary focus is on pregnant women in prison and the healthcare teams responsible for their care.
Collection of guideline questions
A thorough review of the current guidelines, systematic reviews, and original studies relevant to pregnancy management in correctional settings will be performed to refine and gather pertinent clinical questions and outcome indicators. Additionally, structured questionnaires will be distributed among healthcare providers and incarcerated pregnant women. These questionnaires will include questions on the availability of prenatal services, frequency of medical visits, access to nutritional supplements, mental health support, and perceived barriers in the prison setting. Interview guides will also be employed to collect data.
Pregnant inmates will be selected using a purposive sampling strategy. This strategy will consider specific characteristics such as the stage of pregnancy, medical history, and other relevant health factors. The purposive sampling method is chosen because it allows for targeted selection of participants who are able to provide detailed and meaningful insights into the experiences and needs of pregnant women in prison environments. This approach is aligned with the study’s goal to understand the unique healthcare challenges faced by pregnant inmates and to collect data from those who are most likely to contribute valuable information. In-depth interviews will be conducted with pregnant inmates, healthcare practitioners, and prison staff. To conduct these interviews, a screening form will first be used to identify eligible participants. The screening form will include questions on the pregnancy stage (first, second, or third trimester), history of high-risk pregnancy or complications, access to prenatal care within the prison, and willingness to participate in the study. Healthcare staff will assist in identifying potential participants who meet the inclusion criteria. Informed consent will be obtained prior to any data collection to ensure ethical standards are upheld.
Furthermore, medical records will be analyzed to gather specific health-related data and outcomes from the prison setting. This multi-faceted approach will ensure a comprehensive and representative collection of data, providing insights into the needs and care of pregnant women in prison environments.
Identifying and prioritizing critical issues
Utilizing the GRADE system, the evaluation and scoring of questions and outcome indicators will be conducted as follows: scores within the range of 7 to 9 will be regarded as critical for decision-making and forming recommendations; scores between 4 and 6 will be viewed as important; and scores from 1 to 3 will be categorized as having less significance. The Guideline Steering Committee will finalize the selection of questions and outcome indicators to be included in the guideline based on the consensus results gathered during a structured consensus workshop.
Evidence retrieval and synthesis
To develop the clinical guidelines for pregnancy management in prisons, a PICO (patient/population, intervention, comparison, outcomes) framework will be utilized for each key question. Both English and Persian subject headings and relevant free-text terms will be identified. Subsequently, tailored search strategies will be formulated for various databases to address the specific context of this study.
The literature search will encompass a range of databases including PubMed, The Cochrane Library, Web of Science, ClinicalTrials.gov, and relevant Iranian databases such as IranMedex, SID (Scientific Information Database), and Magiran. This search will covered the period from the library’s establishment up to August 2024, and no restrictions will be imposed on the language of publication to ensure the inclusion of articles in all languages that pertain to pregnancy management in correctional environments.
Included literature types will comprise systematic reviews, controlled clinical trials (both randomized and non-randomized), and observational studies (such as cohort studies, case-control studies, and cross-sectional studies). Furthermore, reference lists from the selected literature will be review to enhance the comprehensiveness of the evidence base, ensuring that all relevant studies will be considered in the guideline development process.
Evidence screening and data extraction
To establish the inclusion and exclusion criteria for the literature, we will adhere to the PICO framework pertinent to each guideline question. The review process will involve a meticulous approach, beginning with an assessment of titles and abstracts of identified studies, followed by a comprehensive analysis of the full texts to ensure they met the established criteria. Data will be systematically gathered using a pre-designed extraction form tailored for this project. Two researchers will independently conduct each step of the literature review and data extraction to uphold rigor and reliability. Any differences in interpretation or findings will be addressed through collaborative discussions or by consulting a third-party expert specializing in evidence-based practices. This methodical process aims to ensure a thorough evaluation of the evidence, in accordance with the WHO guidelines for the development of clinical recommendations.
Evaluation of the quality of the literature
In order to assess the methodological quality of the studies included in this research, AMSTAR 2 [17] will be used for systematic reviews, the Cochrane Collaboration’s tool [18] for evaluating the risk of bias in randomized trials, and the Newcastle-Ottawa Scale (NOS) [19] for cohort studies. Additionally, for qualitative studies, appropriate quality assessment tools such as CASP (Critical Appraisal Skills Program) [20] will be applied. The evaluations will be carried out independently by two researchers, and in case of any disagreements, they will be resolved through joint discussion or consultation with an evidence-based methodologist, and if necessary, by referring to a third-party reviewer.
Evidence assessment using GRADE system
The quality of evidence will be graded for the pooled evidence related to each outcome indicator of the guideline questions. Guideline questions that are supported by original research evidence will be assessed using the GRADE system, which considers five downgrading factors: limitations (risk of bias), imprecision, inconsistency, indirectness, and publication bias, as well as three upgrading factors: large effect, dose-response relationship, and all plausible residual confounding. The final certainty of the evidence will be classified as high, moderate, low, or very low [21]. For guideline questions lacking supporting evidence, expert correspondence will be conducted using a nominal group technique to establish expert consensus-based recommendations, referred to as Good Practice Statements (GPS) [22]. The results of the evidence grading for each key guideline question will be reported through the presentation of GRADE evidence profiles [13].
Forming recommendations and reaching consensus
The recommendations will be developed by integrating the values and preferences of the target population with healthcare costs, in accordance with the GRADE Evidence to Decision (EtD) frameworks [23, 24]. All recommendations will be consolidated into a questionnaire for a recommendation letter, which will then be sent to the experts in the consensus group for assessment and suggested revisions. The evidence-based recommendations will be categorized into four levels: strong, weak, strong conditional, and weak conditional, based on the GRADE system.
External review of recommendations
Once the draft guidelines are finalized, they will be submitted to an external review group consisting of five to seven independent experts. These experts will consist of obstetricians, midwives, public health specialists, and professionals with experience in correctional healthcare. To evaluate the quality, clarity, and applicability of the guidelines, each reviewer will complete a structured evaluation form based on the AGREE II instrument, which assesses domains such as scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability, and editorial independence. After collecting individual feedback, a virtual consensus meeting will be organized to review and discuss the comments. This discussion will help to address any discrepancies and ensure the validity, comprehensiveness and feasibility of recommendations. The outcomes of both the structured assessments and the consensus discussion will be documented and used to finalize the guideline document.
Development, publication, and review of the guideline
The finalized guidelines will be compiled into a comprehensive document, which will undergo a peer-review process before publication. To maintain the guidelines’ relevance and effectiveness, a review process will be established to assess and update the published guideline every three years or sooner if new evidence emerges.