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JAMA Intern Med. 2017 Jul 1;177(7):1020-1025. doi: 10.1001/jamainternmed.2017.1302.

Guidance for Modifying the Definition of Diseases: A Checklist.

Author information

Centre for Research in Evidence Based Practice, Bond University, Gold Coast, Australia.
Department of Medicine, Innlandet Hospital Trust, Gjøvik, Norway.
Department of Clinical Policy, American College of Physicians, Philadelphia, Pennsylvania.
Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Canada5Department of Medicine, McMaster University, Hamilton, Canada.
NSW Health Pathology SEALS Department of Clinical Chemistry and Endocrinology, Prince of Wales Hospital, Sydney, Australia.
Duke University, Durham, North Carolina.
Department of Family and Community Medicine, King Saud University, Riyadh, Saudi Arabia.
Department of Clinical Epidemiology and Biostatistics, University of Amsterdam, Amsterdam, the Netherlands.
Brian Wilson Chancellery, University of Queensland, St Lucia, Australia.
Association of the Scientific Medical Societies´ Institute of Medical Knowledge-Management (AWMF-IMWi), Philipps-University, Marburg, Germany.
Department of Strategy, Policy, and Information, World Health Organisation, Geneva, Switzerland.
Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Canada.



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.


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.

[Indexed for MEDLINE]

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