Protocol for the development of a reporting guideline for causal and counterfactual prediction models in biomedicine

Introduction While there are guidelines for reporting on observational studies (eg, Strengthening the Reporting of Observational Studies in Epidemiology, Reporting of Studies Conducted Using Observational Routinely Collected Health Data Statement), estimation of causal effects from both observationa...

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Main Authors: Yi Guo, Hua Xu, Fei Wang, Jie Xu, Jiang Bian, Robert Lucero, Mattia Prosperi
Format: Article
Language:English
Published: BMJ Publishing Group 2022-06-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/6/e059715.full
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author Yi Guo
Hua Xu
Fei Wang
Jie Xu
Jiang Bian
Robert Lucero
Mattia Prosperi
author_facet Yi Guo
Hua Xu
Fei Wang
Jie Xu
Jiang Bian
Robert Lucero
Mattia Prosperi
author_sort Yi Guo
collection DOAJ
description Introduction While there are guidelines for reporting on observational studies (eg, Strengthening the Reporting of Observational Studies in Epidemiology, Reporting of Studies Conducted Using Observational Routinely Collected Health Data Statement), estimation of causal effects from both observational data and randomised experiments (eg, A Guideline for Reporting Mediation Analyses of Randomised Trials and Observational Studies, Consolidated Standards of Reporting Trials, PATH) and on prediction modelling (eg, Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis), none is purposely made for deriving and validating models from observational data to predict counterfactuals for individuals on one or more possible interventions, on the basis of given (or inferred) causal structures. This paper describes methods and processes that will be used to develop a Reporting Guideline for Causal and Counterfactual Prediction Models (PRECOG).Methods and analysis PRECOG will be developed following published guidance from the Enhancing the Quality and Transparency of Health Research (EQUATOR) network and will comprise five stages. Stage 1 will be meetings of a working group every other week with rotating external advisors (active until stage 5). Stage 2 will comprise a systematic review of literature on counterfactual prediction modelling for biomedical sciences (registered in Prospective Register of Systematic Reviews). In stage 3, a computer-based, real-time Delphi survey will be performed to consolidate the PRECOG checklist, involving experts in causal inference, epidemiology, statistics, machine learning, informatics and protocols/standards. Stage 4 will involve the write-up of the PRECOG guideline based on the results from the prior stages. Stage 5 will seek the peer-reviewed publication of the guideline, the scoping/systematic review and dissemination.Ethics and dissemination The study will follow the principles of the Declaration of Helsinki. The study has been registered in EQUATOR and approved by the University of Florida’s Institutional Review Board (#202200495). Informed consent will be obtained from the working groups and the Delphi survey participants. The dissemination of PRECOG and its products will be done through journal publications, conferences, websites and social media.
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spelling doaj-art-72f1f230994d4eaf9791e80437d007ee2025-02-01T13:50:11ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-059715Protocol for the development of a reporting guideline for causal and counterfactual prediction models in biomedicineYi Guo0Hua Xu1Fei Wang2Jie Xu3Jiang Bian4Robert Lucero5Mattia Prosperi6Shanghai Pudong New Area Mental Health Center, Shanghai, ChinaDepartment of Pathology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, ChinaDepartment of Population Health Sciences, Weill Cornell Medical College, Cornell University, New York City, New York, USA1 Department of Epidemiology, Zhengzhou University, Zhengzhou, Henan, China5 Health Outcomes & Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida, USASchool of Nursing, University of California - Los Angeles, Los Angeles, California, USADepartment of Epidemiology, University of Florida, Gainesville, Florida, USAIntroduction While there are guidelines for reporting on observational studies (eg, Strengthening the Reporting of Observational Studies in Epidemiology, Reporting of Studies Conducted Using Observational Routinely Collected Health Data Statement), estimation of causal effects from both observational data and randomised experiments (eg, A Guideline for Reporting Mediation Analyses of Randomised Trials and Observational Studies, Consolidated Standards of Reporting Trials, PATH) and on prediction modelling (eg, Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis), none is purposely made for deriving and validating models from observational data to predict counterfactuals for individuals on one or more possible interventions, on the basis of given (or inferred) causal structures. This paper describes methods and processes that will be used to develop a Reporting Guideline for Causal and Counterfactual Prediction Models (PRECOG).Methods and analysis PRECOG will be developed following published guidance from the Enhancing the Quality and Transparency of Health Research (EQUATOR) network and will comprise five stages. Stage 1 will be meetings of a working group every other week with rotating external advisors (active until stage 5). Stage 2 will comprise a systematic review of literature on counterfactual prediction modelling for biomedical sciences (registered in Prospective Register of Systematic Reviews). In stage 3, a computer-based, real-time Delphi survey will be performed to consolidate the PRECOG checklist, involving experts in causal inference, epidemiology, statistics, machine learning, informatics and protocols/standards. Stage 4 will involve the write-up of the PRECOG guideline based on the results from the prior stages. Stage 5 will seek the peer-reviewed publication of the guideline, the scoping/systematic review and dissemination.Ethics and dissemination The study will follow the principles of the Declaration of Helsinki. The study has been registered in EQUATOR and approved by the University of Florida’s Institutional Review Board (#202200495). Informed consent will be obtained from the working groups and the Delphi survey participants. The dissemination of PRECOG and its products will be done through journal publications, conferences, websites and social media.https://bmjopen.bmj.com/content/12/6/e059715.full
spellingShingle Yi Guo
Hua Xu
Fei Wang
Jie Xu
Jiang Bian
Robert Lucero
Mattia Prosperi
Protocol for the development of a reporting guideline for causal and counterfactual prediction models in biomedicine
BMJ Open
title Protocol for the development of a reporting guideline for causal and counterfactual prediction models in biomedicine
title_full Protocol for the development of a reporting guideline for causal and counterfactual prediction models in biomedicine
title_fullStr Protocol for the development of a reporting guideline for causal and counterfactual prediction models in biomedicine
title_full_unstemmed Protocol for the development of a reporting guideline for causal and counterfactual prediction models in biomedicine
title_short Protocol for the development of a reporting guideline for causal and counterfactual prediction models in biomedicine
title_sort protocol for the development of a reporting guideline for causal and counterfactual prediction models in biomedicine
url https://bmjopen.bmj.com/content/12/6/e059715.full
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