A landmark paper addressing overdiagnosis, published yesterday in the journal JAMA Internal Medicine, outlines the first serious attempt to set some global rules for those experts who move diagnostic goalposts that label more people as sick.
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.
“Medical science is making so much great progress soon none of us will be well”
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:
- a literature review of issues,
- a draft outline document,
- a Delphi process of feedback on the list of issues,
- a 1-day face-to-face meeting,
- and 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.
Sources and Media Releases
- Changes in Disease Definition and Prevalence of a Condition, Wiser Healthcare, 04:59 – 16 mai 2017.
- Checklist of Items to Consider When Modifying a Disease Definition, Wiser Healthcare, 03:31 – 16 mai 2017.
- Guidance for Modifying the Definition of Diseases, A Checklist, JAMA Internal Medicine Special Communication, doi:10.1001/jamainternmed.2017.1302, May 15, 2017.
- How to rein in the widening disease definitions that label more healthy people as sick, the conversation, May 15, 2017.