Development and use of health outcome descriptors: a guideline development case study

Tejan Baldeh, Zuleika Saz-Parkinson, Paola Muti, Nancy Santesso, Gian Paolo Morgano, Wojtek Wiercioch, Robby Nieuwlaat, Axel Gräwingholt, Mireille Broeders, Stephen Duffy, Solveig Hofvind, Lennarth Nystrom, Lydia Ioannidou-Mouzaka, Sue Warman, Helen McGarrigle, Susan Knox, Patricia Fitzpatrick, Paolo Giorgi Rossi, Cecily Quinn, Bettina Borisch, Annette Lebeau, Chris de Wolf, Miranda Langendam, Thomas Piggott, Livia Giordano, Cary van Landsveld-Verhoeven, Jacques Bernier, Peter Rabe, Holger J Schünemann, Tejan Baldeh, Zuleika Saz-Parkinson, Paola Muti, Nancy Santesso, Gian Paolo Morgano, Wojtek Wiercioch, Robby Nieuwlaat, Axel Gräwingholt, Mireille Broeders, Stephen Duffy, Solveig Hofvind, Lennarth Nystrom, Lydia Ioannidou-Mouzaka, Sue Warman, Helen McGarrigle, Susan Knox, Patricia Fitzpatrick, Paolo Giorgi Rossi, Cecily Quinn, Bettina Borisch, Annette Lebeau, Chris de Wolf, Miranda Langendam, Thomas Piggott, Livia Giordano, Cary van Landsveld-Verhoeven, Jacques Bernier, Peter Rabe, Holger J Schünemann

Abstract

Background: During healthcare guideline development, panel members often have implicit, different definitions of health outcomes that can lead to misunderstandings about how important these outcomes are and how to balance benefits and harms. McMaster GRADE Centre researchers developed 'health outcome descriptors' for standardizing descriptions of health outcomes and overcoming these problems to support the European Commission Initiative on Breast Cancer (ECIBC) Guideline Development Group (GDG). We aimed to determine which aspects of the development, content, and use of health outcome descriptors were valuable to guideline developers.

Methods: We developed 24 health outcome descriptors related to breast cancer screening and diagnosis for the European Commission Breast Guideline Development Group (GDG). Eighteen GDG members provided feedback in written format or in interviews. We then evaluated the process and conducted two health utility rating surveys.

Results: Feedback from GDG members revealed that health outcome descriptors are probably useful for developing recommendations and improving transparency of guideline methods. Time commitment, methodology training, and need for multidisciplinary expertise throughout development were considered important determinants of the process. Comparison of the two health utility surveys showed a decrease in standard deviation in the second survey across 21 (88%) of the outcomes.

Conclusions: Health outcome descriptors are feasible and should be developed prior to the outcome prioritization step in the guideline development process. Guideline developers should involve a subgroup of multidisciplinary experts in all stages of development and ensure all guideline panel members are trained in guideline methodology that includes understanding the importance of defining and understanding the outcomes of interest.

Keywords: Guideline methodology; Health outcomes; Health states; Health utility.

Conflict of interest statement

Eight of the authors of this study are members of the GRADE Working Group and have contributed to the development of the GRADE approach to various degrees (TB, HJS, NS, WW, RN, GPM, TP, ML).

Figures

Fig. 1
Fig. 1
Draft Template for Development of Health Outcome Descriptors
Fig. 2
Fig. 2
Health outcome descriptor development process. McMaster researchers developed first drafts of the health outcome descriptors using a template and relevant source material which were reviewed by the entire steering committee. Nineteen volunteers from the GDG panel provided feedback on the drafts in semi-structured interviews and/or online review. This was done through three rounds of semi-structured interviews and online written feedback. Iterative changes were made to the content and format of the health outcome descriptors based upon the observations of the steering committee and GDG feedback collected. In between rounds of feedback, a subset of GDG members also completed two online health utility assessments
Fig. 3
Fig. 3
List of Health outcome descriptors developed for ECIBC
Fig. 4
Fig. 4
Example Health outcome descriptor developed for ECIBC

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