Maternal morbidity measurement tool pilot: Study protocol

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Study Justification:
– The study aims to improve estimates of maternal morbidity, which is important because for every maternal death, 20-30 women suffer morbidity.
– Current estimates of maternal morbidity are not based on standardized methods and measures, leading to limited valid, routine, and comparable measurements.
– Lack of an agreed-upon definition, identification criteria, standardized assessment tools, and indicators has hindered accurate measurement of maternal morbidity.
– Measuring maternal morbidity is essential for resource allocation and service provision to address its impact and improve well-being.
Highlights:
– The study will pilot test a new measurement tool for maternal morbidity in antenatal and postnatal clinical populations.
– The pilot will be conducted in Jamaica, Kenya, and Malawi to compare types of morbidities across settings.
– The study will involve administering a questionnaire to approximately 250 women receiving antenatal care and 250 women receiving postpartum care in each setting.
– The questionnaire includes modules on personal history, patient symptoms, and physical examination.
– Local investigators will lead the pilot in each country, adapting and translating the questionnaires for validity and reliability.
– Data collection will last 2 months at each site, with trained data collectors administering the questionnaire and conducting physical examinations.
– Data will be collected using tablets and uploaded to a secure, password-protected cloud-based storage system.
– Data analysis will be performed by the Geneva-based team using STATA analytical software.
Recommendations:
– Implement the use of the new measurement tool for routine measurement and summary estimates of maternal morbidity.
– Allocate appropriate resources based on the findings of the pilot study to address the impact of maternal morbidity and improve well-being.
– Continue refining and streamlining the questionnaire based on the pilot study results to improve validity and reliability.
– Conduct further research to validate and expand the use of the measurement tool in other settings and populations.
Key Role Players:
– Local investigators: Responsible for leading the pilot study, adapting and translating the questionnaires, and ensuring validity and reliability.
– Data collectors: Trained individuals who administer the questionnaire and conduct physical examinations.
– Site coordinators: Work with data collectors to protect participant anonymity and ensure adherence to ethical guidelines.
– Geneva-based team: Responsible for data analysis and interpretation of the findings.
– Core Maternal Morbidity Working Group (MMWG) members: Provide expertise and guidance in interpreting the data.
Cost Items for Planning Recommendations:
– Training and compensation for data collectors.
– Tablets for data collection.
– Cloud-based storage system for secure data management.
– STATA analytical software for data analysis.
– Travel and logistics for local investigators and site coordinators.
– Token of appreciation for participants.

The strength of evidence for this abstract is 7 out of 10.
The evidence in the abstract is moderately strong. The study protocol outlines a pilot test for measuring maternal morbidity using standardized tools. The methods are clearly described, including the sample size and data collection procedures. However, the abstract does not provide information on the study design, such as whether it is a randomized controlled trial or observational study. Additionally, there is no mention of statistical analysis or potential limitations. To improve the evidence, the abstract could include more details on the study design and analysis plan, as well as potential limitations and biases to be addressed.

Background: While it is estimated that for every maternal death, 20-30 women suffer morbidity, these estimates are not based on standardized methods and measures. Lack of an agreed-upon definition, identification criteria, standardized assessment tools, and indicators has limited valid, routine, and comparable measurements of maternal morbidity. The World Health Organization (WHO) convened the Maternal Morbidity Working Group (MMWG) to develop standardized methods to improve estimates of maternal morbidity. To date, the MMWG has developed a definition and provided input into the development of a set of measurement tools. This protocol outlines the pilot test for measuring maternal morbidity in antenatal and postnatal clinical populations using these new tools. Methods: In each setting, the tools will be piloted on approximately 250 women receiving antenatal care (ANC) (at least 28 weeks pregnant) and 250 women receiving postpartum care (PPC) (at least 6 weeks postpartum). The tools will be administered by trained health care workers. Each tool has three modules as follows: 1. personal history – socio-economic information, and risk-factors (such as violence and substance abuse) 2. patient symptoms – WHO Disability Assessment Schedule (WHODAS) 12-item, and mental health questionnaires, General Anxiety Disorder, 7-item (GAD-7) and Personal Health Questionnaire, 9-item (PHQ-9) 3. physical examination – signs, laboratory tests and results. Discussion: This pilot (planned for Jamaica, Kenya and Malawi) will allow for comparing the types of morbidities women experience between and across settings, and determine the feasibility, acceptability and utility of using a modified, streamlined tool for routine measurement and summary estimates of morbidity to inform resource allocation and service provision. As part of the post-2015 Sustainable Development Goals (SDGs) estimating and measuring maternal morbidity will be essential to ensure appropriate resources are allocated to address its impact and improve well-being.

The study will be cross-sectional, providing a snapshot of maternal morbidity in two study populations (ANC and PPC) in three country settings (Jamaica, Kenya and Malawi). The study will involve the administration of a questionnaire (the aforementioned maternal morbidity tool, presented in Additional files 5 and 6) at the appropriate visit where women are already coming to the facility for care. To describe the different types of morbidity, and stratification by country setting and time of administration (ANC vs PPC), 500 women per country (250 each for ANC and PPC), were deemed adequate for capturing a range of morbidities. Without pooling the data across sites or populations, we will have a 6 % margin of error. A systematic literature review was conducted to identify existing tools and scales to measure aspects of maternal morbidity. Existing measures were brought together to ensure all elements of the maternal morbidity matrix were covered. A draft version of the tool was then reviewed by the Principal Investigators (PIs) from each site, for applicability and feasibility, including the burden on participants. Mock interviews were conducted in each setting to evaluate the flow, content and timing for administering the tool. These mock interviews provided preliminary information on the questions in the tool and participant burden. In each of these steps, the questionnaire was further refined and streamlined. The final pilot questionnaire includes three sections: 1) woman’s history, 2) current symptoms, and 3) a physical examination, including a brief review of her medical records, where available. The tools will focus on the index pregnancy and the woman’s perception of her pregnancy and health. The physical examination will include: a general overview, breast, abdominal, obstetric (for ANC patients) and pelvic (where appropriate) evaluations, in line with routine ANC and PPC examinations. Each country pilot will be led by local investigators who will be responsible for adapting and, where appropriate, translating the questionnaires to ensure their validity and reliability in the study area. Women attending designated facilities for routine maternal health care will be invited to participate in the study. Women for the ANC tool will be invited to participate if they are in their third trimester of pregnancy (28 or more weeks). Women for the PPC tool will be invited to participate if they are approximately 6 or more weeks postpartum. A convenience sampling strategy will be used so that all eligible women will be invited to participate until 250 women are interviewed for each tool (ANC and PPC). Data collection is anticipated to last 2 months at each site. Local investigators will recruit, train, and supervise data collectors. Data collectors will be compensated for their participation in the research. As part of the training process in each country, teams will carefully review each question and conduct mock interviews with training participants (data collectors) who have experience in both ANC and PPC service delivery. The team will check the final version and update the consent forms as needed based on these experiences. Training will emphasize the importance of informed consent and procedures to reduce the risk of interviewers coercing patients to participate in this study. Data collectors trained specifically for this project, will administer informed consent forms (verbal and paper based) to eligible women. Participation will be completely voluntary and non-participation will not affect a woman’s access to or the type of care due to her. This will be expressed to all potential participants during both recruitment and the informed consent session. Additionally, informed consent will ask for access to the woman’s medical records, those available at the facility and those she brings with her (mother-baby book, etc). If the woman is unable to give consent due to mental or physical impairment, she will not be asked to participate in the study. Additionally, data collectors will be trained to exclude minors under the age of 15. The data collectors will also be responsible for referring women to appropriate services when their answers and/or physical exam deem it necessary. The local research team will identify the most appropriate places for referring women, in accordance with local standard of care. In cases where referrals will need to be outside of the facility where data collection is taking place, local PIs will contact the referral sites to confirm that the services are available prior to commencing data collection. Local supervisors will monitor and conduct random checks of interviewers to ensure informed consent and appropriate referral procedures are being followed. The team expects that each woman’s interview will last approximately 45 to 65 min total for the administration of the tool. The physical exam should take between 15 to 25 min, while the interview portion of the questionnaire should take approximately 30 to 40 min. Information being sought on the PPC tool is more comprehensive than the routinely collected data at standard postpartum visits and participants will be informed of this during the consent process. Data collectors will receive and be trained to use a tablet for administering the questionnaire/tool and entering the woman’s data. The tablets will support prompt data collection, transmission, verification, storage and analysis. In addition to the tablets, data collectors will have access to paper forms of the tool, as back up. All tablets will be password protected to ensure confidentiality. Project data will be inputted into electronic forms of either the ANC or PPC survey using Open Data Kit (ODK) an open source data management application on the tablets. The uploaded data will not include any identifying information on the woman, and only an ID number will be used to identify participants. Data from the tablets will be uploaded to a secure, password protected cloud-based storage system owned by WHO (https://whodcp.org). This system allows for both data entry and uploading and remote review and management of collected data. Using tablets for administration of the tool will help ensure data quality with range checks and reduce mistakes associated with manual data entry. Real-time uploading of data to a cloud server will ensure data quality is continually monitored, by the local team and at WHO. The team based in Geneva, in conjunction with site coordinators and PIs, will be responsible for the data analysis. The process will begin while data collection is still on-going in order to assess progress and determine any data collection problems and/or patterns. Once data collection and clean-up are complete the team will perform in-depth analyses using STATA analytical software in order to synthesize and present results. In addition to the Geneva-based team, core MMWG members will be involved in interpreting the data and providing expertise when necessary. Ethical approval for this study was provided by the WHO’s Research Ethics Review Committee (ERC) as well as by the RHR Research Project Panel (RP2), the external review body of the Department of Reproductive Health, and Research (RHR) including the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development, and Research Training in Human Reproduction (HRP) (Additional file 7). Furthermore, relevant entities at each of the three country sites also provided approval. There will be no risk to the women who decide not to participate in the study, they will receive the same standard of care as those who participate in the study. For women who chose to participate, this study may cause some discomfort in terms of the routine physical exams, or when answering personal questions if they are associated with negative experiences (i.e. medical and obstetric history questions about domestic violence or psychological issues). Potential benefits for participants include possible diagnosis and treatment for any reported morbidity or other condition. Only the study team will have access to the information collected and it will remain confidential. Site coordinators will work in conjunction with data collectors to protect participant anonymity. All participants will receive a small token of appreciation for their participation.

Based on the provided information, here are some potential innovations that could be used to improve access to maternal health:

1. Mobile Health (mHealth) Applications: Develop and implement mobile applications that provide pregnant women and new mothers with access to information, resources, and support for maternal health. These apps can provide personalized health advice, appointment reminders, educational materials, and connect women to healthcare providers.

2. Telemedicine: Utilize telemedicine technologies to provide remote consultations and follow-up care for pregnant women and new mothers. This can help overcome geographical barriers and improve access to healthcare services, especially in rural or underserved areas.

3. Community Health Workers: Train and deploy community health workers who can provide maternal health education, support, and basic healthcare services to pregnant women and new mothers in their communities. These workers can help bridge the gap between healthcare facilities and the community, ensuring that women receive the care they need.

4. Transportation Solutions: Develop transportation solutions, such as mobile clinics or transportation vouchers, to help pregnant women and new mothers overcome transportation barriers and access healthcare facilities for antenatal care, postnatal care, and emergency obstetric services.

5. Financial Incentives: Implement financial incentives, such as conditional cash transfers or maternity vouchers, to encourage pregnant women to seek antenatal care and deliver in healthcare facilities. This can help reduce financial barriers and improve access to quality maternal healthcare.

6. Task-Shifting: Train and empower non-physician healthcare providers, such as nurses and midwives, to provide a wider range of maternal healthcare services. This can help alleviate the shortage of skilled healthcare professionals and improve access to care in resource-limited settings.

7. Health Information Systems: Implement robust health information systems that can track and monitor maternal health indicators in real-time. This can help identify gaps in care, monitor progress, and inform decision-making for resource allocation and service provision.

8. Public-Private Partnerships: Foster collaborations between public and private sectors to improve access to maternal health services. This can involve leveraging private sector resources, expertise, and infrastructure to expand healthcare facilities, improve service delivery, and enhance the quality of care.

These innovations, along with the implementation of standardized methods and measures for measuring maternal morbidity, can contribute to improving access to maternal health and reducing maternal morbidity rates.
AI Innovations Description
The recommendation to improve access to maternal health based on the provided description is the development and implementation of a standardized maternal morbidity measurement tool. This tool aims to improve estimates of maternal morbidity by providing standardized methods and measures for identifying and assessing maternal morbidity.

The tool consists of three modules: personal history, patient symptoms, and physical examination. The personal history module collects socio-economic information and risk factors such as violence and substance abuse. The patient symptoms module includes questionnaires to assess disability, mental health, and general anxiety disorder. The physical examination module involves conducting signs, laboratory tests, and results.

The pilot test for measuring maternal morbidity using this tool will be conducted in antenatal and postnatal clinical populations in Jamaica, Kenya, and Malawi. The pilot test will compare the types of morbidities women experience between and across settings and determine the feasibility, acceptability, and utility of using the tool for routine measurement and summary estimates of morbidity.

The study will involve the administration of the questionnaire to approximately 250 women receiving antenatal care and 250 women receiving postpartum care in each setting. Trained healthcare workers will administer the tool, and data collection is expected to last 2 months at each site.

The data collected will be entered into electronic forms using Open Data Kit (ODK) on tablets, ensuring data quality and reducing manual data entry errors. The data will be uploaded to a secure, password-protected cloud-based storage system owned by the World Health Organization (WHO) for analysis.

Ethical approval for the study has been obtained from the WHO’s Research Ethics Review Committee and relevant entities at each country site. Participation in the study is voluntary, and participants will receive the same standard of care whether they choose to participate or not. Confidentiality of the collected information will be maintained, and participants will receive a small token of appreciation for their participation.

Implementing this standardized maternal morbidity measurement tool will provide valuable data on maternal morbidity, enabling better resource allocation and service provision to address its impact and improve well-being.
AI Innovations Methodology
Based on the provided information, here are some potential recommendations to improve access to maternal health:

1. Implement standardized measurement tools: Use the maternal morbidity measurement tool developed by the Maternal Morbidity Working Group (MMWG) to ensure consistent and comparable measurements of maternal morbidity. This tool includes modules for personal history, patient symptoms, and physical examination.

2. Train healthcare workers: Provide training to healthcare workers on how to administer the measurement tools accurately and effectively. This will ensure that the data collected is reliable and valid.

3. Conduct pilot tests: Conduct pilot tests of the measurement tools in different settings, such as Jamaica, Kenya, and Malawi, to assess their feasibility, acceptability, and utility. This will help identify any challenges or modifications needed before implementing the tools on a larger scale.

4. Streamline the measurement tools: Continuously refine and streamline the measurement tools based on feedback from the pilot tests. This will help make the tools more user-friendly and efficient for healthcare workers to use.

5. Ensure ethical considerations: Obtain ethical approval for the study from relevant research ethics committees and ensure that informed consent is obtained from all participants. Protect participant confidentiality and provide appropriate support and referrals for women who may require additional care based on their responses.

To simulate the impact of these recommendations on improving access to maternal health, a methodology could include the following steps:

1. Define the indicators: Identify key indicators that reflect access to maternal health, such as the number of women receiving antenatal and postnatal care, the availability of trained healthcare workers, and the utilization of maternal health services.

2. Collect baseline data: Gather data on the current state of access to maternal health services, including the number of women receiving care, the quality of care provided, and any existing barriers to access.

3. Implement the recommendations: Introduce the recommended innovations, such as the standardized measurement tools and healthcare worker training, in selected healthcare facilities or communities.

4. Monitor and evaluate: Continuously monitor the implementation of the recommendations and collect data on the indicators identified in step 1. This can be done through routine data collection systems, surveys, or interviews with healthcare providers and women accessing maternal health services.

5. Analyze the data: Analyze the collected data to assess the impact of the recommendations on access to maternal health. Compare the baseline data with the data collected after the implementation of the recommendations to identify any changes or improvements.

6. Interpret the results: Interpret the findings to understand the extent to which the recommendations have improved access to maternal health. Identify any challenges or areas for further improvement.

7. Adjust and refine: Based on the results and findings, make any necessary adjustments or refinements to the recommendations to further enhance access to maternal health.

8. Disseminate the findings: Share the results of the impact assessment with relevant stakeholders, including policymakers, healthcare providers, and communities, to inform decision-making and promote further action to improve access to maternal health.

By following this methodology, it will be possible to simulate the impact of the recommendations on improving access to maternal health and make evidence-based decisions for future interventions.

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