A hospital-based birth defects surveillance system in Kampala, Uganda

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Study Justification:
– Birth defects surveillance programs are important for guiding the implementation and evaluation of preventive interventions.
– Many countries with a high burden of birth defects do not have surveillance programs.
– This study aims to share the results of a hospital-based birth defects surveillance program in Uganda, which can be adopted by similar resource-limited countries.
Highlights:
– The study examined all informative births (live births, stillbirths, and spontaneous abortions) at four selected hospitals in Kampala from August 2015 to December 2017.
– Demographic data were collected through maternal interviews and review of hospital patient notes.
– Birth defects were confirmed through bedside examination by a physician and review of photographs and descriptions by a birth defects expert.
– The overall prevalence of birth defects was 66.2 per 10,000 births.
– The most prevalent birth defects were hypospadias, talipes equinovarus, and neural tube defects.
– The least prevalent birth defects were microcephaly, microtia and anotia, and imperforate anus.
Recommendations:
– Implement similar hospital-based birth defects surveillance programs in other resource-limited countries.
– Use active case ascertainment and multiple data sources for comprehensive surveillance.
– Train midwives and physicians in birth defects identification and diagnosis.
– Establish a system for collecting and analyzing surveillance data.
– Use the data to inform prevention policies and service provision needs.
Key Role Players:
– Midwives: Responsible for collecting demographic data and conducting initial examinations of newborns.
– Physicians: Conduct bedside examinations to confirm birth defects.
– Birth Defects Expert: Reviews photographs and descriptions to confirm birth defects.
– Program Manager: Oversees the surveillance program and ensures quality control.
– Data Managers: Manage and analyze the surveillance data.
– CDC Project Monitors: Provide oversight and ensure regulatory compliance.
Cost Items for Planning Recommendations:
– Training: Budget for training midwives and physicians in birth defects identification and diagnosis.
– Data Collection Tools: Allocate funds for android-based tablets and paper forms for data collection.
– Data Management: Set aside resources for data management software and encryption measures.
– Quality Control: Plan for regular quality control activities, including reviews and corrective measures.
– Program Oversight: Allocate funds for program management and CDC project monitoring.
Please note that the actual cost will depend on various factors and should be determined through a detailed budgeting process.

The strength of evidence for this abstract is 8 out of 10.
The evidence in the abstract is strong because it presents the results of a hospital-based birth defects surveillance program in Uganda. The methods used for data collection and confirmation of birth defects are clearly described. The prevalence of birth defects is provided with confidence intervals. The conclusion highlights the importance of the surveillance program in informing prevention policies and service provision needs in low and middle-income countries. To improve the evidence, it would be helpful to include information on the sample size and characteristics of the population studied, as well as any limitations or potential biases in the data collection process.

Background: In 2010, the World Health Assembly passed a resolution calling upon countries to prevent birth defects where possible. Though birth defects surveillance programs are an important source of information to guide implementation and evaluation of preventive interventions, many countries that shoulder the largest burden of birth defects do not have surveillance programs. This paper shares the results of a hospital-based birth defects surveillance program in Uganda which, can be adopted by similar resource-limited countries. Methods: All informative births, including live births, stillbirths and spontaneous abortions; regardless of gestational age, delivered at four selected hospitals in Kampala from August 2015 to December 2017 were examined for birth defects. Demographic data were obtained by midwives through maternal interviews and review of hospital patient notes and entered in an electronic data collection tool. Identified birth defects were confirmed through bedside examination by a physician and review of photographs and a narrative description by a birth defects expert. Informative births (live, still and spontaneous abortions) with a confirmed birth defect were included in the numerator, while the total informative births (live, still and spontaneous abortions) were included in the denominator to estimate the prevalence of birth defects per 10,000 births. Results: The overall prevalence of birth defects was 66.2/10,000 births (95% CI 60.5-72.5). The most prevalent birth defects (per 10,000 births) were: Hypospadias, 23.4/10,000 (95% CI 18.9-28.9); Talipes equinovarus, 14.0/10,000 (95% CI 11.5-17.1) and Neural tube defects, 10.3/10,000 (95% CI 8.2-13.0). The least prevalent were: Microcephaly, 1.6/10,000 (95% CI 0.9-2.8); Microtia and Anotia, 1.6/10,000 (95% CI 0.9-2.8) and Imperforate anus, 2.0/10,000 (95% CI 1.2-3.4). Conclusion: A hospital-based surveillance project with active case ascertainment can generate reliable epidemiologic data about birth defects prevalence and can inform prevention policies and service provision needs in low and middle-income countries.

The birth defects surveillance system uses active case ascertainment and includes obtaining demographic and basic medical information for all births delivered at the participating hospitals. All newborns are examined for major external birth defects by trained midwives. A woman who delivers a baby with a major external birth defect is asked if photographs can be taken of her newborn to help with the diagnosis of the birth defect. Written informed consent is obtained before photographs are taken. If a photograph is not possible, midwives draw and write a detailed description of the defect. Surveillance data are obtained from multiples sources, which include review of patient medical records, interviewer administered questionnaires, and newborn physical examination findings. Figure 1 illustrates the surveillance system activity flow. Surveillance system activity flow All required ethics approvals were obtained as per the Uganda National Council for Science and technology (UNCST) guidelines [14]. This surveillance study was approved by the Joint Clinical Research Centre institutional review board/ethics committee and the US Centers for Disease Control and Prevention Institutional Review Board (IRB) (protocol # 6606.0). The surveillance was also approved by the Uganda National Council of Science and Technology (Ref: HS 1693), The surveillance system is being conducted at four hospitals, including one public/government hospital, Mulago National Referral Hospital and three faith-based private not-for-profit hospitals (Mengo hospital, St. Francis Hospital, Nsambya and Uganda Martyrs Hospital, Lubaga), in Kampala, Uganda. They were selected based on findings from a review of 2012 annual health data from the Ministry of Health, the 2012 annual hospital reports and the Uganda Demographic and Health Survey (UDHS) 2011. While the UDHS 2011 estimated 93% of births in Kampala were health-facility based, the Ministry of Health, 2012 annual health report and the 2012 annual hospital reports revealed 55% of the births in Kampala were at these four hospitals. The four hospitals included in this surveillance project have approximately 50,000 births annually, Mulago National Referral Hospital contributes 60.0% of births while Mengo Hospital, St. Francis Hospital, Nsambya and Uganda Martyrs Hospital, Lubaga contribute 12.0, 13.4 and 14.0% respectively. The time period for this surveillance project is approximately 4 years, during which we would expect to capture approximately 200,000 births. Assuming a birth defects prevalence range of 13.0 per 10,000 births for central nervous system defects to 87.0 per 10,000 births for musculoskeletal defects [4], we expect between 260 and 1740 newborns with each major external birth defect during this time period. All informative births (live, stillbirths and spontaneous abortions), regardless of gestational age, at the four hospitals are included in the birth defects surveillance system. Informative births are those in which the newborn is well formed enough to ascertain the presence or absence of an external birth defect. Birth defects must be diagnosed at birth, during the newborn hospitalization period, or before discharge from the hospital. If prenatal diagnosis of birth defects is available, confirmation must be done at birth. In Uganda, elective termination of pregnancies is not legal except when it preserves maternal life and with consent by two registered physicians. However, all informative spontaneous abortions are included regardless of gestational age. Births outside the four surveillance hospitals and un-informative macerated stillbirths are excluded. All live births and stillbirths are examined by a trained surveillance midwife within 2 h of birth or as soon as feasible, without interrupting the first breastfeeding or preparation for burial. A systematic examination that is “head to toe” and “front to back” is used for every live birth and stillbirth to identify major external birth defects. During this examination, standard measurements are collected, including weight, head circumference and body length. Examination of all newborns is conducted by the surveillance midwife in the presence of the mother and/or relative where possible. All care of live newborns with birth defects is provided through routine care by the hospitals, which includes referral to specialists when available. Data are collected by the surveillance midwife within 24 h after delivery using android-based tablets with paper forms as a back-up. All data collection forms were programmed using Open Data Kit (ODK), an open source data collection platform. All data entered on the tablet are encrypted and only completed forms are transcribed and transmitted to the main application server via internet. To ensure confidentiality, all tablets are password protected, and data are encrypted during transmission to protect it from unauthorized access. For every birth in the four participating hospitals, a surveillance form is completed by the midwife. Surveillance data include maternal demographic data such as age, tribe, address at the time of conception and current residence; brief maternal pregnancy history such as antenatal visit history, parity and history of previous birth defects; HIV sero-status and ART exposure; newborn characteristics such as sex, gestational age, anthropometric measures and presence or absence of birth defects; birth outcome such as live birth, stillbirth and spontaneous abortion. Each mother/newborn pair is assigned a unique study identification number that is generated automatically by the tablets. For multiple deliveries, a form is completed for each newborn. A mother who delivers a child with any major external birth defect is asked if photographs of her child can be taken. If she is willing, written informed consent is obtained and photographs are taken by the trained surveillance midwife using the Android-based tablet. Photographs are taken from several views, including a view of the entire fetus or newborn plus several focused views of the birth defect(s). Many major external birth defects are identified; however this surveillance focuses on birth defects of interest listed in Table 1. The birth defects of interest to the surveillance system a10th International Classification of Diseases modified by the Royal College of Paediatrics and Child Health adaptation bCNS Central nervous system In addition to taking photographs, the examining midwife writes a narrative description of the birth defect(s), detailing the location, size, appearance and other specific details necessary for an independent person who has not seen the infant to envision the birth defect(s) and make a diagnosis. The surveillance midwife then requests a study physician to do an independent bedside examination of any birth that she suspects has a birth defect. The study physician makes an independent diagnosis and prepares an additional independent narrative description. Both the surveillance midwife and the study physician assign diagnosis codes based on the 10th International Classification of Diseases modified by the Royal College of Paediatrics and Child Health adaptation [15], which are either pre-programed in the tablet or available for reference on the tablet. The photographs and the two narrative descriptions are reviewed by the study review team (co-principal investigator and program manager), who may modify the narrative description, diagnosis and diagnostic code when necessary. The final decision is sent to CDC for confirmation of final diagnosis and code assignment. In situations where mothers do not provide consent for photographs to be taken of their newborns, the surveillance midwives make illustrations of the birth defects, write detailed narrative descriptions of the birth defects, and photograph the illustrations. The data collection software (ODK) links the photographs of the infant or the illustration with the mother’s surveillance information. Quality control and assurance are addressed in several ways. To standardize study activities, all study staff were trained on the principles of Good Clinical Practice [16], the study protocol, and how to conduct the surveillance activities. In addition, standard operating procedures were developed to ensure systematic collection of data and reduce interpersonal and inter-site variability. Study data undergo three levels of quality control. Quality control level 1 combines use of real-time electronic and manual data checks. Quality control level 2 is a manual data check completed by study research assistants to ensure data completeness and validity. Quality control level 3 combines both manual and electronic reviews that are completed by the data managers, program manager and investigators. To ensure inclusion of all births, hospital delivery registers are reconciled with the information in the database on a regular basis. Data from births that may have been discharged from the hospital and not included by surveillance midwives are abstracted from the patient medical file and entered by surveillance research assistants. Quality assurance activities are regularly conducted by the program manager and CDC project monitors. The program manager regularly reviews 10.0% of randomly selected data collected in the past month to assess quality, completeness and regulatory compliance and implements corrective and preventive measures. These data include all newborns with birth defects, all cases and controls and a simple random sample of data from other participants not in the mentioned categories to add up to 10.0% data collected each month. Descriptive statistics of the population included in the surveillance system were generated, including maternal characteristics and infant characteristics. This includes the distribution of birth defects by maternal age, parity, maternal HIV sero-status, newborn sex, birth outcome, type of pregnancy, and mode of delivery. The birth defects prevalence at the four surveillance hospitals was calculated for each major birth defect by aggregating the number of birth defect cases as the numerator and the total number of informative births (live births, stillbirths and spontaneous abortions) at the surveillance hospitals as the denominator. An infant or fetus with multiple birth defects was counted as a separate case for each defect [17]. Prevalence was expressed per 10,000 informative births (live births, stillbirths and spontaneous abortions) using the following formula during a specific time period: The 95% confidence interval for each prevalence estimate was calculated using Wilson bounds [18].

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The hospital-based birth defects surveillance system in Kampala, Uganda is an innovative approach to improving access to maternal health. It includes several key innovations:

1. Active case ascertainment: The surveillance system actively collects data on all informative births, including live births, stillbirths, and spontaneous abortions, regardless of gestational age. This ensures that all births with potential birth defects are included in the surveillance.

2. Comprehensive data collection: The surveillance system collects demographic and basic medical information for each birth, including maternal demographic data, pregnancy history, newborn characteristics, and birth outcomes. This comprehensive data allows for a better understanding of the prevalence and distribution of birth defects.

3. External birth defect examination: Trained midwives conduct systematic examinations of all live births and stillbirths to identify major external birth defects. This helps in the early detection and diagnosis of birth defects.

4. Use of technology: The surveillance system utilizes android-based tablets with paper forms as a backup for data collection. This allows for efficient and secure data entry, encryption, and transmission to the main application server.

5. Collaboration and review: The surveillance system involves collaboration between midwives, physicians, birth defects experts, and review teams. This multi-disciplinary approach ensures accurate diagnosis and coding of birth defects.

6. Quality control and assurance: The surveillance system incorporates multiple levels of quality control and assurance, including real-time electronic and manual data checks, manual data checks by research assistants, and reviews by data managers and program managers. This helps maintain data completeness, validity, and regulatory compliance.

By implementing these innovations, the hospital-based birth defects surveillance system in Kampala, Uganda is able to generate reliable epidemiologic data about birth defects prevalence. This data can inform prevention policies and service provision needs in low and middle-income countries, ultimately improving access to maternal health.
AI Innovations Description
The recommendation to improve access to maternal health based on the described birth defects surveillance system in Kampala, Uganda is to implement similar hospital-based surveillance programs in other resource-limited countries. This recommendation is supported by the following key features of the surveillance system:

1. Active case ascertainment: The surveillance system actively collects data on birth defects by examining all informative births (live births, stillbirths, and spontaneous abortions) delivered at the participating hospitals. This ensures comprehensive coverage and accurate estimation of birth defects prevalence.

2. Data collection methods: Trained midwives obtain demographic and basic medical information through maternal interviews, review of hospital patient notes, and newborn physical examinations. This multi-source approach enhances data accuracy and completeness.

3. Use of technology: The surveillance system utilizes android-based tablets with paper forms as a backup for data collection. This improves efficiency, data security, and enables real-time data transmission for analysis and decision-making.

4. Ethical considerations: The surveillance study obtained all necessary ethics approvals and ensured confidentiality and privacy of the collected data. Written informed consent was obtained from mothers for photographing newborns with birth defects.

5. Quality control and assurance: The surveillance system implemented multiple levels of quality control, including real-time electronic and manual data checks, manual data review by research assistants, and regular quality assurance activities by the program manager and project monitors.

By adopting and adapting this hospital-based birth defects surveillance system, other countries can generate reliable epidemiological data on birth defects prevalence. This data can inform the development and evaluation of preventive interventions, as well as guide policies and service provision related to maternal health.
AI Innovations Methodology
Based on the information provided, here are some potential recommendations for improving access to maternal health:

1. Implement a birth defects surveillance system: Establish a hospital-based surveillance program to monitor and track birth defects in resource-limited countries. This program should involve active case ascertainment, including the collection of demographic data, medical information, and physical examinations of newborns.

2. Train healthcare professionals: Provide training to midwives and other healthcare professionals on how to identify and document birth defects accurately. This will ensure consistent and reliable data collection.

3. Utilize technology for data collection: Use electronic data collection tools, such as android-based tablets with Open Data Kit (ODK) software, to streamline and standardize data collection. This will improve efficiency and reduce errors in data entry.

4. Obtain informed consent for data collection: Prioritize obtaining written informed consent from mothers before collecting any data or photographs related to birth defects. Ensure that privacy and confidentiality are maintained throughout the process.

5. Collaborate with experts: Engage birth defects experts to review and confirm the diagnosis of birth defects based on photographs and narrative descriptions. This will enhance the accuracy and reliability of the surveillance data.

To simulate the impact of these recommendations on improving access to maternal health, a methodology could be developed as follows:

1. Define the objectives: Clearly outline the specific goals and outcomes that the recommendations aim to achieve. For example, the objective could be to increase the detection and reporting of birth defects in resource-limited countries.

2. Identify key indicators: Determine the key indicators that will be used to measure the impact of the recommendations. This could include the number of birth defects detected, the accuracy of diagnoses, and the timeliness of data collection.

3. Collect baseline data: Gather baseline data on the current state of birth defects surveillance and access to maternal health in the target countries. This will serve as a reference point for comparison after implementing the recommendations.

4. Implement the recommendations: Put the recommendations into practice, ensuring that all relevant stakeholders are involved and trained accordingly. Monitor the implementation process and address any challenges or barriers that arise.

5. Measure the impact: Collect data on the key indicators identified in step 2 after the recommendations have been implemented. Compare this data to the baseline data to assess the impact of the recommendations on improving access to maternal health.

6. Analyze the results: Analyze the data collected to determine the extent to which the recommendations have improved access to maternal health. Identify any trends, patterns, or areas for further improvement.

7. Adjust and refine: Based on the results of the analysis, make any necessary adjustments or refinements to the recommendations. Continuously monitor and evaluate the impact of the recommendations to ensure ongoing improvement.

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

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