Guidance for modifying the definition of diseases: A checklist

Jenny Doust, Per Olav Vandvik, Amir Qaseem, Reem A Mustafa, Andrea R Horvath, Allen Frances, Lubna A. Al-Ansary, Patrick Bossuyt, Robyn L Ward, Ina Kopp, Laragh Gollogly, Holger Schunemann, Paul Glasziou

Research output: Contribution to journalArticleResearchpeer-review

32 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1020-1025
Number of pages6
JournalJAMA Internal Medicine
Volume177
Issue number7
Early online date15 May 2017
DOIs
Publication statusPublished - 1 Jul 2017

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Checklist
Guidelines
Patient Harm
Gestational Diabetes
Documentation
Population

Cite this

Doust, Jenny ; Vandvik, Per Olav ; Qaseem, Amir ; Mustafa, Reem A ; Horvath, Andrea R ; Frances, Allen ; Al-Ansary, Lubna A. ; Bossuyt, Patrick ; Ward, Robyn L ; Kopp, Ina ; Gollogly, Laragh ; Schunemann, Holger ; Glasziou, Paul. / Guidance for modifying the definition of diseases : A checklist. In: JAMA Internal Medicine. 2017 ; Vol. 177, No. 7. pp. 1020-1025.
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Doust, J, Vandvik, PO, Qaseem, A, Mustafa, RA, Horvath, AR, Frances, A, Al-Ansary, LA, Bossuyt, P, Ward, RL, Kopp, I, Gollogly, L, Schunemann, H & Glasziou, P 2017, 'Guidance for modifying the definition of diseases: A checklist' JAMA Internal Medicine, vol. 177, no. 7, pp. 1020-1025. https://doi.org/10.1001/jamainternmed.2017.1302

Guidance for modifying the definition of diseases : A checklist. / Doust, Jenny; Vandvik, Per Olav; Qaseem, Amir; Mustafa, Reem A; Horvath, Andrea R; Frances, Allen; Al-Ansary, Lubna A.; Bossuyt, Patrick; Ward, Robyn L; Kopp, Ina; Gollogly, Laragh; Schunemann, Holger; Glasziou, Paul.

In: JAMA Internal Medicine, Vol. 177, No. 7, 01.07.2017, p. 1020-1025.

Research output: Contribution to journalArticleResearchpeer-review

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AU - Frances, Allen

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AU - Bossuyt, Patrick

AU - Ward, Robyn L

AU - Kopp, Ina

AU - Gollogly, Laragh

AU - Schunemann, Holger

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Doust J, Vandvik PO, Qaseem A, Mustafa RA, Horvath AR, Frances A et al. Guidance for modifying the definition of diseases: A checklist. JAMA Internal Medicine. 2017 Jul 1;177(7):1020-1025. https://doi.org/10.1001/jamainternmed.2017.1302