The National Clinical Effectiveness Committee (NCEC) requires consideration of evidence on both the clinical and cost-effectiveness of health technologies in the development of all National Clinical Guidelines in Ireland. The completion of a budget impact analysis (BIA) of the implementation of a National Clinical Guideline is also a required step. The role of HRB-CICER is to independently review evidence and provide scientific support for the development, by guideline development groups, of these evidence-based National Clinical Guidelines.

The overall aim of National Clinical Guideline No. 23 is to stratify a woman’s clinical risk at the first hospital antenatal visit and during all subsequent antenatal appointments into normal, medium and high risk pregnancies. National Clinical Guideline No. 23 has been developed using the ADAPTE process, a systematic approach for considering the endorsement or modification of recommendations produced in one setting for application in another. As part of the ADAPTE process, HRB-CICER conducted:

1. A systematic review of clinical guidelines on risk stratification during pregnancy.  
2. A three-round modified Delphi process to identify risk factors for inclusion as criteria within the guideline.
3. A systematic review on the cost-effectiveness literature on formal risk stratification systems during the antenatal period.

A BIA was conducted to quantify the resource implications to the Health Service Executive (HSE) following implementation of the guideline. The key change to service delivery that will occur as a result of implementation of the guideline recommendations, is the modification of the current electronic patient record to allow for the conduct and recording of the standardised risk assessment, and to manage the on-going assignment of women to appropriate care streams over the course of their pregnancy.

Creating a Better Future Together: National Maternity Strategy 2016–2026, published in February 2016, advocates a risk-based approach to ensure that women are provided with the most appropriate model of care in line with their clinical risk. The National Maternity Strategy highlighted the need to stratify pregnant women according to their clinical risk into one of three risk groups: normal risk, medium risk and high risk. Accordingly, this National Clinical Guideline provides recommendations on stratifying a woman’s clinical risk into one of these risk categories at the first hospital antenatal visit and during all subsequent antenatal appointments, so to ensure that the model of care they are provided is at all times in line with their clinical risk.

The systematic review of clinical guidelines and the review of review on the cost-effectiveness of using a formal risk stratification system during the antenatal period to support the development of National Clinical Guideline No. 23 was carried out in accordance with agreed HRB-CICER processes and following the HIQA guidelines for the retrieval and interpretation of economic literature. The systematic review of existing clinical guidelines of stratification of risk in pregnancy did not identify a high-quality guideline with a three-level risk stratification (as described in the National Maternity Strategy). Risk factors were extracted from three high-quality guidelines, identified through the systematic review. A three-round modified Delphi method was used to establish consensus on which of these risk factors should be included in the current guideline.

The BIA was conducted in accordance with the HIQA guidelines for budget impact analysis and economic evaluation in Ireland.