GRADE notes: How to use GRADE when there is “no” evidence? A case study of using registry data

Poster
2024 Prague [Global Evidence Summit]
El Mikati I1, Mustapha R2, Begin B3, Borzych-Duzalkac D4, Neu A5, Richardson T6, Schaefer F7, Warady B8
1Department of Internal Medicine, Johns Hopkins Bayview Medical Center, Baltimore, MD, USA
2Division of Nephrology and Hypertension, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, USA; Department of Health Research Methods, Evidence, and Impact, McMaster University, Ontario, N/A, Canada
3Doernbecher Children’s Hospital, Oregon Health & Science University, Portland, OR, USA
4Department and Clinic of Pediatrics, Nephrology and Hypertension, Medical University of Gdansk, Gdansk, N/A, Poland
5Johns Hopkins University School of Medicine, Baltimore, MD, USA
6Children’s Hospital Association, Lenexa, KS, USA
7University of Heidelberg, Center of Pediatric and Adolescent Medicine, Heidelberg, N/A, Germany
8Division of Pediatric Nephrology, Children’s Mercy Kansas City, Kansas City, MO, USA, Kansas City, MO, USA

Background:

Trustworthy guidelines rely on systematic reviews of the best available published evidence. Guidance about developing evidence-based recommendations when published direct evidence is lacking is needed.

Objectives:

We aim to provide a case example as a solution to generate primary data using registry data.

Methods:

When direct published literature was absent, a team of clinical and statistical expertise was able to utilize registry data for primary data generation in a way that allows for answering clinically important questions.

Results:

Out of 54 questions prioritized by the panel for peritonitis guideline update, 25 questions had no evidence to inform them. The use of registry data served as primary source of information to answer 12 out the 25 questions and provided additional information for 9 questions for which at least one published study was available.

Conclusions:

This paper extends previous GRADE note for scenarios of “no” evidence highlighting the value of generation of primary data using registry data when relevant registries and resources allow. This approach can of be special value when addressing conditions that are rare or populations that are considered vulnerable while emphasizing the importance ensuring transparent reporting of raw data and the analysis plan in the event of reporting unpublished work.