Title

Guidance for modifying the definition of diseases: A checklist

Date of this Version

5-15-2017

Document Type

Journal Article

Grant Number

National Health and Research Council Program Grant 633003: Screening and Test Evaluation Program

Publication Details

Published version

Doust, J., Vandvik, P. O., Qaseem, A., Mustafa, R. A., Horvath, A. R., Frances, A., Al-Ansary, L., Bossuyt, P., Ward, R. L., Kopp, I., Gollogly, L., Schunemann, H., Glasziou, P. (2017, in press). Guidance for modifying the definition of diseases: A checklist. JAMA Internal Medicine. doi: 10.1001/jamainternmed.2017.1302

Access the journal

Copyright © 2017 American Medical Association. All rights reserved.

Free public access: All research articles are freely available on the day of publication on The JAMA Network Reader and 12 months after publication on the journal's website

ISSN

2168-6114

Abstract

Importance:

No guidelines exist currently for guideline panels and others considering changes to disease definitions. Panels frequently widen disease definitions, increasing the proportion of the population labeled as unwell and potentially causing harm to patients. We set out to develop a checklist of issues, with guidance, for panels to consider prior to modifying a disease definition.

Observations:

We assembled a multidisciplinary, multicontinent working group of 13 members, including members from the Guidelines International Network, Grading of Recommendations Assessment, Development and Evaluation working group, and the World Health Organisation.

We used a 5-step process to develop the checklist:

(1) a literature review of issues,

(2) a draft outline document,

(3) a Delphi process of feedback on the list of issues,

(4) a 1-day face-to-face meeting, and

(5) further refinement of the checklist.

The literature review identified 12 potential issues. From these, the group developed an 8-item checklist that consisted of definition changes, number of people affected, trigger, prognostic ability, disease definition precision and accuracy, potential benefits, potential harms, and the balance between potential harms and benefits. The checklist is accompanied by an explanation of each item and the types of evidence to assess each one. We used a panel's recent consideration of a proposed change in the definition of gestational diabetes mellitus (GDM) to illustrate use of the checklist.

Conclusions and Relevance:

We propose that the checklist be piloted and validated by groups developing new guidelines. We anticipate that the use of the checklist will be a first step to guidance and better documentation of definition changes prior to introducing modified disease definitions.

 

This document has been peer reviewed.