TY - JOUR
T1 - Guidance for modifying the definition of diseases
T2 - A checklist
AU - Doust, Jenny
AU - Vandvik, Per Olav
AU - Qaseem, Amir
AU - Mustafa, Reem A
AU - Horvath, Andrea R
AU - Frances, Allen
AU - Al-Ansary, Lubna A.
AU - Bossuyt, Patrick
AU - Ward, Robyn L
AU - Kopp, Ina
AU - Gollogly, Laragh
AU - Schunemann, Holger
AU - Glasziou, Paul
PY - 2017/7/1
Y1 - 2017/7/1
N2 - 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.
AB - 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.
UR - https://www.scopus.com/record/display.uri?eid=2-s2.0-85024477388&origin=inward&txGid=25ec1124c6922e0816fa6d5df27d846e
U2 - 10.1001/jamainternmed.2017.1302
DO - 10.1001/jamainternmed.2017.1302
M3 - Article
C2 - 28505266
SN - 2168-6106
VL - 177
SP - 1020
EP - 1025
JO - JAMA Internal Medicine
JF - JAMA Internal Medicine
IS - 7
ER -