Formative research and development of innovative tools for “better Outcomes in Labour Difficulty” (BOLD): Study protocol Obstetrics

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Study Justification:
– Complications during labor and childbirth can be prevented with timely interventions by skilled healthcare providers.
– The quality and outcomes of childbirth care are suboptimal in many health facilities in low-resource settings.
– The World Health Organization has initiated the “Better Outcomes in Labour Difficulty” (BOLD) project to address weaknesses in labor care processes and better connect health systems and communities.
– The project aims to develop a “Simplified, Effective, Labour Monitoring-to-Action” tool (SELMA) to assist healthcare providers in monitoring labor and taking decisive actions more efficiently.
– The project also aims to develop an innovative set of service prototypes and/or tools called “Passport to Safer Birth” to promote access to quality care for women during childbirth.
Highlights:
– The study will employ qualitative research and service design methodologies in eight health facilities and their catchment communities in Nigeria and Uganda.
– Focus group discussions (FGDs) and in-depth interviews (IDIs) will be conducted among healthcare providers, facility administrators, and women who have delivered in a health facility.
– The study will provide an in-depth understanding of healthcare providers and health system issues to be accounted for in the final design and implementation of SELMA.
– The study will identify key moments (“touch points”) where women’s experiences of childbirth care are shaped and where the overall experience of quality care could be improved.
– The findings will help identify potential areas for behavior change related to the provision and experience of childbirth care and serve as the basis for the development of Passport to Safer Birth.
Recommendations:
– Develop the SELMA tool to assist healthcare providers in monitoring labor and taking decisive actions more efficiently.
– Develop the Passport to Safer Birth service prototypes and/or tools to promote access to quality care for women during childbirth.
– Implement behavior change strategies based on the findings to improve the provision and experience of childbirth care.
Key Role Players:
– Healthcare providers (including midwives, medical officers, and obstetricians)
– Facility administrators
– Women who have delivered in a health facility
– Community health workers
– Traditional birth attendants
– Hospital reception and admission staff
– Design researchers from M4ID (service design organization)
– Local research partners
Cost Items for Planning Recommendations:
– Training sessions for research teams
– Transcription and translation of interviews and observations
– Data management and analysis
– Travel expenses for research teams
– Reimbursement for participants’ transportation
– Report writing and result dissemination

The strength of evidence for this abstract is 8 out of 10.
The evidence in the abstract is strong because it describes a well-designed study protocol that employs qualitative research and service design methodologies. The study aims to address weaknesses in labour care processes and improve the quality and outcomes of childbirth care in low-resource settings. The protocol outlines the research activities, including focus group discussions, in-depth interviews, observations, and analysis procedures. The study also emphasizes the importance of ethical considerations and inclusivity of vulnerable populations. To improve the evidence, the abstract could provide more specific details about the expected outcomes and potential impact of the study.

Background: Most complications during labour and childbirth could be averted with timely interventions by skilled healthcare providers. Yet, the quality and outcomes of childbirth care remains suboptimal in many health facilities in low-resource settings. To accelerate the reduction of childbirth-related maternal, fetal and newborn mortality and morbidity, the World Health Organization has initiated the “Better Outcomes in Labour Difficulty” (BOLD) project to address weaknesses in labour care processes and better connect health systems and communities. The project seeks to develop a “Simplified, Effective, Labour Monitoring-to-Action” tool (SELMA) to assist healthcare providers to monitor labour and take decisive actions more efficiently; and by developing an innovative set of service prototypes and/or tools termed “Passport to Safer Birth”, designed with communities and healthcare providers, to promote access to quality care for women during childbirth. This protocol describes the formative research activities to support the development of these tools. Methods/Design: We will employ qualitative research and service design methodologies in eight health facilities and their catchment communities in Nigeria and Uganda. In the health facilities, focus group discussions (FGD) and in-depth interviews (IDI) will be conducted among different cadres of healthcare providers and facility administrators. In the communities, FGDs and IDIs will be conducted among women who have delivered in a health facility. We will use service design methods to explore women’s journey to access and receive childbirth care in order to innovate and design services around the needs and expectations of women, within the context of the health system. Discussion: This formative research will serve several roles. First, it will provide an in-depth understanding of healthcare providers and health system issues to be accounted for in the final design and implementation of SELMA. Second, it will help to identify key moments (“touch points”) where women’s experiences of childbirth care are shaped, and where the overall experience of quality care could be improved. The synthesis of findings from the qualitative and service design activities will help identify potential areas for behaviour change related to the provision and experience of childbirth care, and serve as the basis for the development of Passport to Safer Birth. Please see related articles ‘http://dx.doi.org/ 10.1186/s12978-015-0027-6 ‘∈and ‘http://dx.doi.org/ 10.1186/s12978-015-0029-4 ‘.

In order to achieve the first and second objectives of the formative research, we will employ qualitative research methodologies among healthcare providers in eight selected health facilities, and among women and community members in the facility catchment areas in Nigeria and Uganda. First, focus group discussions (FGDs) and in-depth interviews (IDIs) will be conducted among different cadres of healthcare providers, as well as IDIs with health facility administrators. These FGDs and IDIs will explore healthcare providers’ and administrators’ expectations and needs relating to provision of quality intrapartum care, as well as barriers and enablers to the provision of high quality care in labour monitoring-to-action. Furthermore, FGDs and IDIs will be conducted among women of reproductive age (15–49 years) who have delivered in any health facility in the previous 12 months to explore their expectations and needs to improve their care experiences during childbirth. To meet the third objective, we will use a service design approach to provide design specifications for the development of SELMA and Passport to Safer Birth. ‘Service design’ is a multidisciplinary approach to design new or improve existing services around the needs of service users and providers with the aim to make them more useful, desirable, effective and efficient [20,21]. Service design applies user-centred methods to innovate and shape services organised around people’s needs and desires, with consideration of the constraints and possibilities of service providers and environments. Using a service design approach in health care has demonstrated benefits related to improving the creative process, the service provided, project management, and organizational culture [20-28]. The use of creative methods to identify and design new service opportunities in an iterative processes of testing and refining facilitates the development of solutions that enable lasting relationships between service providers and recipients. Although some of its methods are similar to qualitative research methods (such as interviews and small group discussions), design research differs from qualitative research in that it is less formal and uses visual tools of documentation as an outcome to inform and inspire the design team. Design research aims to map a holistic picture of a social phenomena or service environment and outline the interdependences, such as stakeholders, service interactions, perceptions and emotions. Figure 2 describes an example of the service design process. An example of a service design process. Within the context of the BOLD project, we will explore healthcare providers’ interactions with the health system and consider available resources, constraints and the context in which they operate. We will also explore the context of pregnant women and their experiences, values and preferences relating to facility-based childbirth. For the purposes of this protocol, the qualitative research design and procedures related to the first and second study objectives will first be presented, followed by the service design approach and procedures related to the third study objective. This study will be conducted in eight health facilities and communities within each facility catchment area, in Nigeria and Uganda (four health facilities from each country). These health facilities have been identified for the BOLD project in collaboration with the country principal investigators with consideration of the following inclusion criteria: Three groups of participants have been identified for this part of the study: [1] facility administrators; [2] healthcare providers; and [3] women who have given birth in any health facility in the previous twelve months. From each of the selected facilities, facility administrators, such as the head of the obstetrics and gynaecology department or the head of the hospital, will be invited to participate in IDIs. Healthcare providers from the selected facilities, including midwives, medical officers and obstetricians, will be invited to participate in FGDs and IDIs. FGDs and IDIs will not be conducted with the same healthcare providers to avoid redundancy among participants. If the number of healthcare providers is insufficient to constitute the pre-determined focus group in any facility, only IDIs will be performed among such providers. Two health facilities in each country will be sampled and women who reside in the catchment areas of these selected facilities will be invited to participate in the study. This process will be facilitated by the country and local study teams. FGDs will be conducted with women of reproductive age (15–49 years) who have delivered in any health facility in the previous 12 months to explore normative expectations, needs, and opportunities to improve their care experiences during childbirth. Additionally, IDIs will also be conducted with women of reproductive age (15–49 years) who have recently delivered in any health facility to explore their personal expectations, needs and opportunities to improve their care experiences during childbirth. The country principal investigators, social scientists and local research teams will facilitate contact with women in the communities within the selected facility catchment areas, as well as the healthcare providers and facility administrators from each facility. Each individual will be invited to participate and if they agree, will be asked to provide consent. All FGDs and IDIs will take place in a private setting and will be audio recorded. FGDs and IDIs are anticipated to last approximately 60 to 90 minutes and will be conducted by trained qualitative researchers from the country teams. For the FGDs and IDIs conducted with women who recently delivered, the moderators will be female. Once the facilities are selected, the catchment area for each facility will be defined for sampling purposes. Purposive sampling will be used to achieve a stratified sample without random selection. This method uses pre-specified parameters to stratify the sample [32]. The sampling grid (Table 2) outlines the proposed stratification for women, healthcare providers and administrators. In each study facility, healthcare providers will be sampled based on their cadre, such as nurse/midwives or doctors/specialists. In each facility, facility administrators will be selected for IDIs. We expect the type or designation of facility administrators to vary by facility, but at the minimum would include the medical administrative head of the facility and the head of the obstetrics and gynaecology department. Sampling grid to be used in each country (Nigeria and Uganda) for qualitative research to meet objectives 1 and 2 In each country, two facilities will be selected, and women will be sampled for IDIs and FGDs from within their facility catchment areas by the lead social scientist in each country. Women who recently delivered in any health facility will be identified in collaboration with community health workers using community mobilization mechanisms. Women who delivered outside of a health facility will be excluded from this sample, because this project seeks to explore women’s experiences of care provided at the facility-level, rather than barriers and facilitators to facility-based childbirth care. All of the instruments will use the format of semi-structured discussion guides and are available upon request. IDI discussion guides for facility administrators will include the following domains: FGD and IDI guides for healthcare providers will include the following: FGD and IDI guides for women will include the following domains: Prior to data collection, a one-week training session will be conducted in Nigeria and Uganda for all research teams, including country PIs, social scientists, data collectors, research assistants, transcribers and translators. The training session will include objectives of the study, data collection procedures, practice sessions with the tools, pilot-testing in a health facility and community, as well as highlighting ethical considerations. The WHO qualitative research team with support from the social science team leads of each country will train the country qualitative research teams, which will include social scientists, focus group moderators and interviewers from University of Ibadan, Nigeria and Makerere University, Uganda. The lead social scientist from each country will ensure that experienced moderators and interviewers are invited to participate in the study. A manual of operation (moderator’s guide) will be developed by the WHO team with inputs from country collaborators to standardize the quality of data collection across both countries. During the data collection period, the transcription and translation will occur in parallel to data collection and will be shared on an on-going basis with the study team to ensure the quality of the data. Country PIs will be in constant communication with the interviewers in the field in order to respond to any issues that arise during data collection. Transcripts will be reviewed throughout the data collection process to ensure data content and quality. A random sample of six transcripts (three per country) will be back-translated into the local language to ensure translation quality. All digitally recorded qualitative data (group discussions and interviews) will first be transcribed verbatim in the original language used for collection using a structured transcription format. Verbatim transcription will be performed close to the time of completion of the interviews/discussions to maintain the originality of the discussion without loss of themes. Observations and assessments during interviews will be written up as field notes. The transcripts will be complemented with notes taken during the interviews/group discussions. Data transcription will be performed under the supervision of the designated social scientist who will review it for completeness. The transcripts in local languages will be then be translated into English by an independent translator following the original transcription format. All translated transcripts will undergo another round of consistency checks by country lead social scientist to maintain high data quality. The lead social scientists from both countries will manage the audio and transcribed files, and will transfer them electronically to a WHO project staff in charge of BOLD qualitative study at a regular interval that is mutually agreed upon (e.g. weekly or fortnightly). The WHO project staff will be tasked with data management of the transcripts and audio files. Transcripts will be stored in Atlas.ti computer software and stored on a password-protected computer accessible only to the study team. Transcripts will be de-identified and participants will be identifiable only by a unique identifier code. Participant’s names and personal information will not be recorded. Thorough debriefing sessions will be conducted between the lead social scientist and the research assistants on a mutually agreed upon schedule to review field notes, adjust interview guides, and identify potential questions or scenarios of interest or confusion to clarify through member checking in subsequent interviews. We will employ a two-pronged approach for the formal analysis: [1] conduct local analysis workshops with the research assistants in each country; and [2] line-by-line coding to develop a thematic framework and coding scheme. In each country, the local analysis workshop will be facilitated by the lead social scientist and the WHO qualitative research lead to foster a hands-on capacity building activity for research assistants engaged in the project and to share insights from the data collection process to develop better understanding of the local context. The WHO qualitative research lead, in conjunction with the qualitative research team, will conduct line-by-line open coding on a sample of the translated transcripts to develop the thematic framework. The thematic framework will also be informed by the study objectives to explore the barriers and facilitators to the provision of high quality care in labour monitoring-to-action, and expectations and needs of both healthcare workers and women during intrapartum care. The thematic framework will inform the development of a hierarchical coding scheme, which we will apply systematically to all transcripts using Atlas.ti (version 7.1.7 Scientific Software Development GmbH, Eden Prairie, MN). Text units indexed according to each emergent theme will be further analysed and interpreted by the larger study team. We will explore common themes that span geographic and cultural differences while identifying important differences across settings that need to be accounted for during the tool development stage. As a hospital-based tool that is anticipated to be globally applicable to settings similar to both Uganda and Nigeria, SELMA development will only be informed by themes that are common to both study settings. However, the Passport to Safer Birth will be designed to respond to local issues and context and its development will be informed by themes that are most relevant and specific to study settings. The process of Passport to Safer Birth development will be carefully documented to allow reproducibility and future scale-up to other settings. Close collaboration between the WHO qualitative research team, the lead social scientists, and the research assistants will ensure quality analysis and interpretation of the data across sites. The service design approach will be conducted by partner social enterprise organization with technical input from WHO. The service design activities are devised to support the development of the study tools (SELMA and Passport to Safer Birth) to improve access to respectful, quality care during childbirth. Using the service design process, we will identify key moments and places (“touch points”) where women come in contact with maternal health services and where their subjective experience is shaped. These touch points represent the location or time that the desired emotional and sensory connection to health services needs to be established. The preliminary results from the qualitative research discussed in the sections above will also complement and contribute to the outputs from the service design activities. Figure 3 depicts the iterative process used in design research to gather data, develop prototypes with target users and design solutions to be tested with real users. BOLD iterative design process. In the first phase of the service design process, we will conduct design research in the selected health facilities and facility catchment areas in Nigeria and Uganda to gather insights from both facility staff and women through the use of participatory observations and interviews. Figure 4 depicts the draft template of a user journey map of women from the pre-pregnancy to postpartum period that will guide the design process. This user-journey will be used as a guide during observations and interviews to identify, map and adjust touch points throughout a woman’s journey, as well as understand women’s expectations and needs, stakeholder involvement, barriers, challenges, and opportunities for improvement. As service design employs an iterative approach, insights gathered from the initial round of observations and interviews will influence the structure of the next round of observations and interviews. Draft template of user journey map. We will conduct participatory observations of consenting individuals from the target groups, to explore and engage with their environment, activities, behaviours, interactions with individuals from other target groups, decision-patterns, as well as interplay with physical objects or technology relevant to the BOLD project. The observations will be systematically documented, but will differ slightly in their degree of formality, level of structuring and recording methods (depending on whether the observation is in the community or the health facility). The service design researcher may ask questions or engage participants in conversation, while avoiding interruption to natural routines, activities and interactions. The observations will enable the design team to identify, analyse, prioritize, and visualize existing practices and perceptions around the time of onset of labour, and map the journey of women to and within the health facility. The observation schedule for facilities will be developed in conjunction with the facility administrator to find a time of day to conduct the observations that respects the workflow within the facilities. For example, if antenatal clinics are only held on weekday mornings, observations for the antenatal clinic will be held on a mutually agreed upon weekday morning. Key points of observation will include the following: Participants and locations for the facility observations will be identified by the facility administrator. As the facility setting is dynamic in nature, it is not possible to specify in advance the number of participants who will be observed. The observations are designed to capture as naturalistic of a setting as possible; therefore, consent will not be asked of every person who would be observed. Observations in the communities will be coordinated with the local partners, which include a local service design team and community focal points. Key points of observation will include community meetings, public social areas in the community (i.e. marketplace or bar), community health worker visits and women’s daily activities in the home and community Participants and locations for the community observations will be identified by the local partners. Consent will be sought from the community contact person (e.g. community leader) for these observations. As the observations are designed to capture as naturalistic of a setting as possible, consent will not be asked of every person who would be observed in large group gatherings. When conducting the observations in the facilities and communities, the service design research team will be discreet enough to not disrupt normal activity, yet open enough so that the people under observation do not feel that their privacy is compromised. All relevant people in authority (i.e. facility administrators, heads of wards, community leaders) will be alerted to the presence and purpose of the research team and will provide consent for the observation. If someone under observation queries directly about the role of the research team, an honest, open and polite answer will be provided. If informal discussions occur with those under observation, the research team will emphasize that they are not required to talk to the research team and there will be no repercussions if they chose not to. Confidentiality will be maintained through the period of observations and the identities of those who are observed will be protected and will not be linkable to the data. Individuals from the following target groups will be selected for the observational sessions: [1] pregnant women (in second and third trimester, including when travelling to the facility); [2] women during labour and childbirth and immediate postpartum (where deemed acceptable by mother/family and considered feasible by health staff); [3] women and their newborn (returning to the community); [4] family members of women; [5] traditional birth attendants; [6] community health workers; [7] hospital reception and admission staff; [8] facility-based nurses, midwives and doctors. We will conduct semi-structured interviews with facility staff and women within the service environment (i.e. in health facility for both staff and women) or context (i.e. in the community for women), allowing the interviewer to both observe and probe behaviour at the same time. These interviews will help design researchers to gain an understanding of the social and physical environment surrounding the potential service. Consenting individuals from the following target groups will be invited to participate in the interviews: [1] pregnant women (in second and third trimester); [2] women during labour and childbirth and immediate postpartum (where deemed acceptable by mother/family and considered feasible by health staff); [3] women and their newborn (returning to the community); [4] family members of women; [5] traditional birth attendants; [6] community health workers; [7] hospital reception and admission staff; [8] facility-based nurses, midwives and doctors. The interviews will be conducted based on discussion guides (available upon request), which will be refined following the observations and themes identified in the user journey map. Several visual tools such as illustrations, mood boards and other imagery will be used as discussion help to stimulate thoughts and ideas. Eight health facilities and communities within each facility catchment area in Nigeria and Uganda (four health facilities from each country) have been identified for the BOLD project. The service design approach will be implemented in each of the BOLD sites with an additional rural site in each country to provide a different perspective. Healthcare providers from the study facilities will be invited to participate in observation and semi-structured interviews. Women of reproductive age (15–49 years) who are either pregnant or have delivered in a facility in the previous 12 months who reside in the catchment areas of the selected facilities will be invited to participate in observations and semi-structured interviews. The country principal investigators and local design research partner will facilitate contact with the women in the communities within the selected facility catchment areas as well as the healthcare providers and recently delivered women in the selected facilities. Each individual will be invited to participate, and if they agree, will be asked to provide consent. The interviews will be audio recorded. Interviews are anticipated to last approximately 60 minutes and will be conducted by trained local research partners and design researchers. The discussion moderator for the interviews and observations conducted with women in the community or facility will be female. Observations are anticipated to last at least 60–90 minutes depending on the work context, key points of observation and availability for observation. Purposive sampling will be used to achieve a stratified sample without random selection. The objective of the Passport to Safer Birth is to create a better linkage between communities and facilities and to stimulate the demand for respectful, humane, and quality intrapartum care. Since a woman’s decisions regarding care-seeking during pregnancy and childbirth is often influenced by her significant others, we will also include other stakeholders in the interviews, including husbands/male partners, in-laws, heads of households and other close family members. These participants will be recruited through the women who participate in the interviews, and the interviewer will ask the woman if their husbands/partners and/or other family members will be available for participation in a separate interview. The observational domains for service design will include the following: In the community: In the health facility: The research team will follow the above guiding frame during the observations but departures from the plan are anticipated and allowed in response to unexpected events during observation. Documentation of the observations will be through note taking, sketches, and occasionally through photographs, audio recording/or video footage (with consent and when deemed appropriate and not intrusive to the staff and woman). There will be no visual documentation (e.g. photograph or video footage recording) during sensitive medical or personal situations (e.g. breast, abdominal or pelvic examinations, surgical operation, emergencies, experience of labour pain, birth or bereavement). The most important events to observe are preparatory tasks or documentation executed by hospital staff during care provision, activities at critical locations in the health facility (e.g. waiting room/hall, entrance, admission) and medical equipment and materials. Care will be taken by the design team to limit the intrusion into the healthcare setting and to maintain women’s privacy and confidentiality. The design researchers will also carry out a review sessions after each observation day together with the local partners in order to review, clarify, summarize and document the days gathered information. This will then be used, together with the detailed recordings, as the basis for the analysis phase. Interview guides for women and community members will include the following domains, which will be refined following the observations and themes identified in the user journey map. Interview guides for health workers will include the following domains, which will be refined following the observations and themes identified in the user journey map: Prior to data collection, the service design partners in collaboration with the principal investigators will hold a BOLD service design kick-off meeting with key stakeholders, including study coordinators from each health facility, community health workers from the study catchment communities and local research partners. The meeting will launch the service design activities and provide an overview of objectives, the concept of service design, data collection and analysis procedures and ethical considerations. The service design team will train the local research and design partners on the study tools and procedures. During the data collection period, the transcription will occur in parallel to data collection and will be shared on an on-going basis with the study team. The service design team, local research partners and principal investigators will be in constant communication to respond to any issues that arise during data collection. The above described service design activities will be coordinated by M4ID, a not-for-profit social enterprise leveraging communication and technology for health and development based in Finland. M4ID will use the findings from the primary qualitative research to inform the service design process, and is responsible for leading the participatory service design component (in conjunction with in-country service design partners), developing the prototypes for Passport to Safer Birth, community testing and refining the prototypes, and a final documentation of a strategic roadmap for the production and implementation of Passport to Safer Birth in future work. All digitally recorded interviews will transcribed verbatim into English by local research partners. Observations, assessments and preliminary design ideas will be written and drawn as field notes by M4ID service designers and will complement the transcripts. Transcripts will be stored on a password-protected computer accessible only to the study team. Transcripts will be de-identified and participants will be identifiable only by a unique identifier code. Participant’s names and personal information will not be recorded. Findings from the service design insights will be organized and analysed using a service design approach, including: [33]: A summary analysis utilizing the above analytic process will be used to develop a prioritized design guideline, which will inform concept ideation, solution design (SELMA design specifications), and the development of prototypes (Passport to Safer Birth). The qualitative research and service design components will be managed by WHO BOLD study coordinating unit, at the WHO Department of Reproductive Health and Research, Geneva, Switzerland. In Nigeria and Uganda, the country principal investigators will establish research teams that will implement the research and design activities. The qualitative research component will be executed by local social science teams in Nigeria and Uganda. The service design component will be executed by M4ID, a service design organization from Finland, in collaboration with local innovation and research partners. The study coordinating unit in Geneva will conduct site visits before and during the implementation of the study to contribute to study site selection, training workshops and assessment of adherence to study protocols. Training of country research teams will take place at convenient sites in both countries. There will be continuous communication between country research teams and study coordinating unit at the WHO. Regular contacts will be made and statutory teleconferences will be arranged to ensure that the timeline are followed and problems resolved without delay. This study will employ broad participation criteria to be as inclusive as possible of all cadres of healthcare providers and women with different life situations (including religion orientation, socioeconomic status, ethnicity, age). Therefore specific sub-groups of healthcare providers or women are not disadvantaged through being unable to participate in the study. Potential participants in the hospital and the community will be identified and invited by trained research staff who are familiar with the facility and the community. All potential participants will receive information about the study in their language of choice, conforming to ethical requirements for research involving human subjects. The language will be easy to understand and free of technical jargons. Participants will be given sufficient time to reflect on the information and ask questions. Those who consent to participate in the study will be requested to sign an informed consent form, and it will be made clear that they are free to withdraw from the study at any stage without risk of any negative consequences. For illiterate women, an impartial witness will be present during the entire informed consent reading and discussion. Both the witness and the individual discussing the consent will sign and date the consent form. The contact details of the local investigators, including telephone numbers, will be made available to the participants should they require further information and assistance. Other safeguards will include the use of unique participant numbers on all data collection forms, and ensuring that interviewers and data collectors are not current or previous employees of the study facility. It is possible that women who participate in the semi-structured interviews may become upset if they have experienced a traumatic birth experience and the interview revives their feeling of distress. However, most questions on the interview guide will explore women’s expectations and needs during the intrapartum period rather than exploring traumatic birth experiences. Interviewers will be trained on how to support any woman who becomes upset during the interview, including how to initiate and follow up referral to appropriate section of the hospital where the woman could receive psychological support. Participants will not experience any direct and/or immediate benefits for participating in the study. However, the study will be gathering information to inform the development of tools that have the potential to improve the quality of labour management in the future. Study participants and other women using or intending to use facilities for childbirth will benefit from the increased scientific knowledge on this topic, which will ultimately promote women-centred care of high quality in the facilities. Vulnerable or potentially vulnerable sub-populations (such as unmarried women, adolescents, women of different ethnicities, migrant women and women who are HIV positive) may participate in this study. We consider it important to ensure that the selection of participants did not discriminate against any group, as women in this category may be at greater risk of receiving poor quality care in the facility. If such women are included, they will be protected by the universal standards of confidentiality and privacy that apply to all participants. However, all women, including these vulnerable groups, will be free to refuse to participate, both confidentially and without prejudice. All participants in both the qualitative research and service design research activities will receive a small reimbursement to cover their transportation to the venue of the interview. The value of this payment will be determined in consultation with the country principal investigators, to ensure that it does not constitute an inducement. Quality of care during childbirth has been identified as an important issue in low-income settings, and even as a human rights issue. The findings of this study will inform the development of innovative tools to improve how intrapartum care is delivered by health providers and the standard of care experienced by women delivering in the health facilities. There will be no form of deception in this study. The WHO HRP Review Panel on Research Projects (RP2) comprising of external reviewers and WHO scientific staff reviewed and approved the scientific and technical content of the study (protocol ID, A65878). Ethics approval was obtained from the WHO Research Ethics Review Committee (ERC) and ethics review authorities of all participating sites (Federal Capital Territory Health Research Ethics Committee and Ondo State Ministry of Health Research Ethics Review Committee in Nigeria, and Makerere School of Health Sciences Research and Ethics Committee in Uganda. The time frame for the formative research and the development of prototypes for both SELMA and Passport to Safer Birth is two years, out of which approximately four months will be dedicated to the finalisation of research and ethical reviews at the WHO and at local institutional levels. The data collection and analyses are expected to be completed over a period of eight months. As the design of SELMA and Passport to Safer Birth will depend on the results from this phase (qualitative and service design research), the development of their prototypes will overlap with the final phase of data analyses. Report writing and result dissemination will occur after the formative phase is complete.

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The “Better Outcomes in Labour Difficulty” (BOLD) project aims to improve access to maternal health by addressing weaknesses in labour care processes and better connecting health systems and communities. The project includes the development of two innovative tools: the “Simplified, Effective, Labour Monitoring-to-Action” (SELMA) tool and the “Passport to Safer Birth” service prototypes.

The SELMA tool is designed to assist healthcare providers in monitoring labour and taking decisive actions more efficiently. It will be developed based on in-depth understanding of healthcare providers’ expectations and needs, as well as barriers and enablers to the provision of high-quality care in labour monitoring-to-action. The tool will help improve the quality and outcomes of childbirth care by providing healthcare providers with the necessary information and guidance to make timely interventions.

The Passport to Safer Birth service prototypes aim to promote access to quality care for women during childbirth. These prototypes will be developed through a service design approach, which involves understanding women’s journey to access and receive childbirth care and designing services around their needs and expectations. The prototypes will be designed to improve the overall experience of quality care and address key moments (“touch points”) where women’s experiences of childbirth care are shaped.

The formative research activities for the development of these tools will include qualitative research and service design methodologies. Qualitative research will involve focus group discussions and in-depth interviews with healthcare providers, facility administrators, and women who have delivered in a health facility. Service design activities will include participatory observations and interviews with facility staff and women in the community.

Overall, the innovations for potential recommendations to improve access to maternal health include the development of the SELMA tool and the Passport to Safer Birth service prototypes. These tools aim to enhance the monitoring and action during labour and improve the overall experience of quality care for women during childbirth.
AI Innovations Description
The recommendation to improve access to maternal health is to develop innovative tools called “Simplified, Effective, Labour Monitoring-to-Action” (SELMA) and “Passport to Safer Birth”. SELMA is designed to assist healthcare providers in monitoring labor and taking decisive actions more efficiently. Passport to Safer Birth is a set of service prototypes and/or tools designed with communities and healthcare providers to promote access to quality care for women during childbirth.

To develop these tools, formative research activities will be conducted in eight health facilities and their catchment communities in Nigeria and Uganda. Qualitative research and service design methodologies will be used to gather insights from healthcare providers, facility administrators, and women who have delivered in a health facility. The research will explore healthcare providers’ expectations and needs, as well as barriers and enablers to providing high-quality care during labor. It will also identify key moments where women’s experiences of childbirth care can be improved.

The findings from the formative research will inform the development of SELMA and Passport to Safer Birth. The service design approach will be used to design solutions that meet the needs and expectations of women and healthcare providers. The process will involve participatory observations, interviews, and the use of visual tools to stimulate thoughts and ideas. The design team will identify touch points where women come in contact with maternal health services and where their experience is shaped.

The development of SELMA and Passport to Safer Birth will be carefully documented to ensure reproducibility and future scale-up to other settings. The tools will aim to improve access to respectful, quality care during childbirth and address weaknesses in labor care processes. The ultimate goal is to reduce childbirth-related maternal, fetal, and newborn mortality and morbidity.

The findings from this research will contribute to the scientific knowledge on improving the quality of labor management and promote women-centered care in health facilities. The study has obtained ethics approval and will ensure the confidentiality and privacy of participants. The time frame for the research and development of prototypes is approximately two years, with data collection and analysis expected to be completed over eight months.
AI Innovations Methodology
The methodology described in the abstract involves conducting formative research activities in eight health facilities and their catchment communities in Nigeria and Uganda. The research will use qualitative research and service design methodologies to gather insights from healthcare providers, facility administrators, and women who have delivered in a health facility. The research will explore healthcare providers’ expectations and needs, as well as barriers and enablers to providing high-quality care during labor. It will also identify key moments where women’s experiences of childbirth care can be improved.

The findings from the formative research will inform the development of two tools: Simplified, Effective, Labour Monitoring-to-Action (SELMA) and Passport to Safer Birth. SELMA is designed to assist healthcare providers in monitoring labor and taking decisive actions more efficiently. Passport to Safer Birth is a set of service prototypes and/or tools designed with communities and healthcare providers to promote access to quality care for women during childbirth.

The service design approach will be used to design solutions that meet the needs and expectations of women and healthcare providers. This will involve participatory observations, interviews, and the use of visual tools to stimulate thoughts and ideas. The design team will identify touch points where women come in contact with maternal health services and where their experience is shaped.

The development of SELMA and Passport to Safer Birth will be carefully documented to ensure reproducibility and future scale-up to other settings. The tools aim to improve access to respectful, quality care during childbirth and address weaknesses in labor care processes. The ultimate goal is to reduce childbirth-related maternal, fetal, and newborn mortality and morbidity.

The findings from this research will contribute to the scientific knowledge on improving the quality of labor management and promote women-centered care in health facilities. The study has obtained ethics approval and will ensure the confidentiality and privacy of participants. The time frame for the research and development of prototypes is approximately two years, with data collection and analysis expected to be completed over eight months.

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