3.12 Data Management and Protocols

Data management is essential to ensuring the integrity and confidentiality of surveillance data. Data management will not be possible unless all participating personnel are trained in the protocol for data collection. This ensures the proper use of all tools and a standardized method for data collection. This can be achieved by creating and maintaining an organized system for smooth data flow that ensures the regular availability of data but that also has high levels of security to preserve confidentiality. Fig. 3.15 is an example of how data collected at the hospital or clinic level progress through a surveillance programme.

Figure 3.15. Example flow chart for data management
Figure 3.15. Example flow chart for data management

The protocol for data collection and management includes procedures for:

  • identification and registration of congenital anomalies by health-care professionals in each participating hospital unit;
  • training of personnel responsible for coding congenital anomalies according to the ICD-10 (12) coding system;
  • taking photographs of fetuses or neonates with congenital anomalies, if appropriate for the setting (see Appendix J);
  • verifying the information at the participating hospital site; and
  • sending information to the regional or national-level surveillance programme.

Cases of congenital anomalies are usually identified as they occur in the participating delivery settings in a catchment area. Hospital personnel who identify a fetus or neonate with a congenital anomaly/anomalies usually record this information in a logbook, based on established standardized procedures.

Identification of cases is based on specific criteria, and diagnosis at birth is made by an experienced health-care provider. If an experienced health-care provider is not available at the site, photographs of the fetus or neonate with a congenital anomaly can be taken and kept in the medical record, for a later verification of the diagnosis by an experienced health-care provider or specialist, or a panel of experts, working as part of the congenital anomalies surveillance programme (26). A member of the hospital staff, or a specially trained individual, usually takes at least three pictures – one frontal photograph of the fetus or neonate, one showing the back, and one or more pictures of the affected part(s) of the body. It is important, if possible, to place a tape measure next to the affected area or areas when taking the photograph, to document the size of the affected area, and ensure that some form of identification number is included in the photograph in order that it can be correctly linked to a particular case. For more suggestions on taking photographs of the fetus or neonate with a congenital anomaly, please refer to Appendix J.

The frequency of reporting data to the regional or national registry (e.g. weekly or monthly reporting) can be defined in the surveillance protocol and will depend on the availability of surveillance personnel and the individual circumstances of the participating unit.

A protocol is developed for the regional or national level, for personnel working in the surveillance programme. The protocol includes procedures for:

  • data verification;
  • criteria to include cases in the database;
  • analysing data;
  • reporting and sharing data;
  • protecting the patient’s and family’s private information;
  • maintaining confidentiality (please refer to Chapter 2 for more information on privacy and confidentiality); and
  • case referral and management – clinical and surgical, if applicable.

Data-management personnel are responsible for reviewing information sent from the participating hospitals, and assessing the completeness of data forms, whether each item has been completed, and whether the verbatim and coded diagnoses have been included. In situations in which information appears incorrect or incomplete, personnel overseeing the verification of data can return the form to the site and ask for it to be re-reviewed or completed, or both. Cases submitted to the surveillance programme are then to be reviewed by a clinician, to verify the congenital anomaly and its coding prior to the case being entered into the database.