Useful resources for the development of congenital anomaly surveillance programmes
Birth Defects Surveillance: A manual for programme managers
This manual has been designed to assist with the local development of both population based and hospital based congenital anomaly surveillance systems. It is intended that the user will gain information on the planning and evaluation of a surveillance system as well as the coding of congenital anomalies and analysis of the data. Specific guidance is available on the use of logic models, legislation, consent and prevalence figures of selected anomalies in a range of countries. The manual is intended to be used in conjunction with the WHO/ICBDSR/CDC Birth defects surveillance: atlas of selected congenital anomalies.
ICBDSR: PreSurv Suite
PreSurv Suite is public domain suite of software tools designed for the global community of public health practitioners and researchers, for the Prevention and Surveillance of birth defects. It provides for data entry form and database construction, and data analyses and output for cases with birth defects. PreSurv Suite was developed by ICBD-International Centre on Birth Defects, Headquarter Centre of ICBDSR, in collaboration with CDC-Centers for Disease Control and Prevention. It is a EpiInfo based tool.
European Surveillance of Congenital Anomalies (EUROCAT): EUROCAT Guide 1.4 Guidelines for Registration
EUROCAT is the European network of population-based registries for the epidemiologic surveillance of congenital anomalies. This Guide sets out the variables used by EUROCAT and their coding, lists minor congenital anomalies for exclusion, lists EUROCAT congenital anomaly subgroups and their ICD coding, describes data quality indicators, and algorithms for classification of multiple anomalies. Methodology used by EUROCAT is more fully described in a special issue of Birth Defects Research.
EUROCAT Data Management Program (EDMP)
The EUROCAT Data Management Program is a tool written in Microsoft Access used to assist with the collection, management, reporting and analysis of congenital anomaly data. It is compatible with EUROCAT Guide 1.4. It has an easy to use data entry, edit and search interface. Users can also import congenital anomaly data from other databases, and export their data to other databases. There is a standard data validation function. The program automatically assigning ICD10/BPA codes to EUROCAT subgroups, excludes the EUROCAT list of minor anomalies, and creates prevalence tables for all EUROCAT subgroups or user defined subgroups. A specific statistical monitoring module allows the detection of clusters and trends over time, as described in two publications: EUROCAT statistical monitoring: Identification and investigation of ten year trends of congenital anomalies in Europe and Using scan statistics for congenital anomalies surveillance: the EUROCAT methodology. The EDMP is not currently available for download, but may be available on request.
EUROCAT Data Quality Indicators
As part of its data quality strategy, EUROCAT developed a set of data quality indicators (DQIs) in 2005. These DQIs are indicators calculated on the total dataset for each registry, which serve to highlight the strengths and weaknesses of the data. The DQIs help to focus the attention of registries on areas needing improvement, and they are useful to data users for the interpretation of data. The DQIs cover the following areas: completeness of case ascertainment, accuracy of diagnosis, completeness of information on EUROCAT variables, timeliness of data transmission, and availability of population denominator information. Tables comparing each registry to the average for the EUROCAT network are updated annually.
WHO-TDR: Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings
A protocol has been published in BMC Pregnancy and Childbirth for collecting data on the risks of birth defects due to medicines for diseases like HIV and malaria. The major components of first line treatments for these diseases are not recommended during the first trimester, yet many women may take these medications before they are aware that they are pregnant. In sub-Saharan Africa, 68% of the world’s HIV population reside and approximately 25 million pregnant women are at risk of malaria, so the risks are great.
The protocol is neither disease nor drug-specific. Indeed, the power of the approach lies in its broad application to a variety of settings in which women may have more than one infectious disease or condition during the course of the pregnancy and may also have been exposed to many drugs. Its methods, case record forms and training materials (including a DVD showing how to conduct a surface examination of a newborn) have been tested for feasibility in five countries (four in Africa and one in South America), further refined and used in the WHO Pregnancy Registry. The approach is integrated within the reproductive health system of the country, specifically antenatal clinics and labor/delivery facilities.
There are three important features of this pregnancy registry protocol which stand out from most other registries. The first, is the simplicity of including women agreeing to take part at their first facility visit for care during the pregnancy. This not only represents the population of pregnant women coming for care but also enables later comparison of birth defects among women who have been exposed to a medicine with those who have not. The second feature is the generic applicability of the approach irrespective of drug or disease, and the third is the improvement of staff capacity to manage and monitor pregnancies and newborns. These qualities add to the practicality and cost-effectiveness of the protocol.
The materials developed are available to any country wishing to join the registry, on condition that there is a commitment to train the staff to use these materials to obtain reliable data on drug exposure and to conduct a systematic surface examination of the newborn. The registry builds capacity within the health system to improve maternal and neonatal care as well as to serve as a sentinel surveillance system for the safety of medicines used in pregnant women.
Central registry for epidemiological surveillance of drug safety in pregnancy, WHO-TDR
The World Health Organization Central registry for epidemiological surveillance of drug safety in pregnancy is a collaborative initiative to generate reliable evidence on the safety of drugs during pregnancy. This work is developed by the Special Programme for Research and Training in tropical diseases (TDR) in collaboration with other WHO departments, in particular the HIV department, which recommends toxicity surveillance during pregnancy in the context of antiretroviral use.
The purpose is to facilitate pooling of safety data issued from local or national pregnancy exposure registries or collected in birth outcome surveillance programmes to support early detection of any potential signal of teratogenicity and provide evidence to inform treatment guidelines for pregnant patients. The pooled data will only be accessible to WHO, and the WHO will undertake periodic analysis of the data collected within the framework of signal detection. Countries, surveillance projects and researchers are invited to contribute data.
ECLAMC Operational Manual
This is available on request to ECLAMC, in Spanish or Portuguese, including the registration protocol for cases and controls in hospitals, and data variables to be collected.
National Birth Defects Prevention Network Surveillance Guidelines
The technical guidelines in this document consist of a series of chapters covering the fundamental aspects of developing, planning, implementing, and conducting surveillance for birth defects and using the resulting data. They provide a way of improving the quality of birth defects surveillance data, which in turn enhances their use.
GAIA: Global Alignment of Immunization Safety Assessment in Pregnancy
GAIA aims to improve data generated for strengthening programs of immunization in pregnancy by harmonizing maternal, pregnancy, fetal, and neonatal health outcome assessment with specific focus on Low and Middle Income Countries (LMIC). The following paper on congenital anomalies is available through this organization:
DeSilva M, Munoz FM, Mcmillan M, Kawai AT, Marshall H, Macartney KK, Joshi J, Oneko M, Rose AE, Dolk H, Trotta F, Spiegel H, Tomczyk S, Shrestha A, Kochhar S, Kharbanda EO; Brighton Collaboration Congenital Anomalies Working Group. Congenital anomalies: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2016 Dec 1;34(49):6015-6026. doi: 10.1016/j.vaccine.2016.03.047. (open access)
WHO-recommended surveillance standards of rubella and congenital rubella syndrome
WHO provides a downloadable PDF for the surveillance standards of rubella and congenital rubella syndrome. Congenital rubella syndrom (CRS) is associated with various birth defects including heart disease, blindness, deafness and mental retardation.