Introduction

Early pregnancy problems are thought to lead to over 500 000 visits and about 50 000 admissions to UK hospitals annually. The emotional cost to women and their partners is considerable, and both miscarriage and ectopic pregnancy (EP) are associated with significant morbidity and even mortality.

In 2013, a National Institute for Health and Care Excellence (NICE) guideline was produced on the diagnosis and initial management in early pregnancy of EP and miscarriage.1 The attention given by NICE to this clinical area is welcome and is to be applauded. Understandably in many places it is not evidence based, but represents the opinion of members of the guideline development group that produced the document. This is problematic as it means that the initial draft guidance reflected the views of a very small number of people with clinical experience of the conditions under review. A similar point was also made recently in relation to the NICE draft guidance on intra-partum care.2 Furthermore the content of NICE guidance is not subject to formal peer review as would be expected with any other publication. Whilst feedback is invited, there is no requirement for NICE to incorporate such feedback in a way that requires aspects of the guidance to be acceptable to stakeholders. As a result the inclusion criteria, data synthesis and conclusions drawn when developing such guidance are not rigorously tested. This is a weakness in the process.

Whilst NICE does have a stated way of assessing tests (QUADAS-2), difficulties may arise if evidence is considered to be of poor quality as this leads to the opinions of NICE panels being perhaps too influential in what is or is not included in final guidance. The quality indicators used by NICE are however a concern. As high-quality evidence is only deemed to relate to randomised …