The role of real-world data in the development of treatment guidelines: a case study on guideline developers\u2019 opinions about using observational data on antibiotic prescribing in primary care

Stephanie Steels,Tjeerd Pieter van Staa

doi:10.1186/s12913-019-4787-5

Abstract

BackgroundAntimicrobial resistance (AMR) is a prominent threat to public health. Although many guidelines have been developed over the years to tackle this issue, their impact on health care practice varies. Guidelines are often based on evidence from clinical trials, but these have limitations, particularly in the breadth and generalisability of the evidence and evaluation of the guidelines’ uptake. The aim of this study was to investigate how national and local guidelines for managing common infections are developed and explore guideline committee members’ opinions about using real-world observational evidence in the guideline development process.MethodsSix semi-structured interviews were completed with participants who had contributed to the development or adjustment of national or local guidelines on antimicrobial prescribing over the past 5 years (from the English National Institute for Health and Care Excellence (NICE)). Interviews were audio recorded and transcribed verbatim. Data was analysed thematically. This also included review of policy documents including guidelines, reports and minutes of guideline development group meetings that were available to the public.ResultsThree key themes emerged through our analysis: perception versus actual guideline development process, using other types of evidence in the guideline development process, and guidelines are not enough to change antibiotic prescribing behaviour. In addition, our study was able to provide some insight between the documented and actual guideline development process within NICE, as well as how local guidelines are developed, including differences in types of evidence used.ConclusionsThis case study indicates that there is the potential for a wider range of evidence to be included as part of the guideline development process at both the national and local levels. There was a general agreement that the inclusion of observational data would be appropriate in enhancing the guideline development process, as well providing a potential solution for monitoring guideline use in clinical practice, and improving the implementation of treatment guidelines in primary care.

Highlights

Antimicrobial resistance (AMR) is a prominent threat to public health
Three key themes emerged through our study: 1) Perception versus actual guideline development process, 2) Using other types of evidence in the guideline development process, and 3) Guidelines are not enough for changing antibiotic prescribing behaviour
Theme 1: perception versus actual guideline development process Whilst publicly available documents gave a general overview of the process involved for developing national guidelines, the interviews provided a more detailed description of the methods used and who was involved throughout the process

Summary

Introduction

Antimicrobial resistance (AMR) is a prominent threat to public health. many guidelines have been developed over the years to tackle this issue, their impact on health care practice varies. The route from scientific literature to a new or updated guideline passes through the development of assessments of evidence by a group of guideline committee members and experts in a medical topic. This process of development of guidelines is not straightforward and has been characterised as a ‘black box’ [2]. The guideline committee members who develop and adapt a guideline, develop and adapt guidelines based on a variety of sources, over and above the available evidence This differs to EBM where other types of studies, such as cohort and case-control studies may be considered [1]

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