Reporting guideline for the early stage clinical evaluation of decision support systems driven by artificial intelligence: DECIDE-AI. (18th May 2022)

• Record Type: Journal Article
• Authors: Vasey, Baptiste; Nagendran, Myura; Campbell, Bruce; Clifton, David A; Collins, Gary S; Denaxas, Spiros; Denniston, Alastair K; Faes, Livia; Geerts, Bart; Ibrahim, Mudathir; Liu, Xiaoxuan; Mateen, Bilal A; Mathur, Piyush; McCradden, Melissa D; Morgan, Lauren; Ordish, Johan; Rogers, Campbell; Saria, Suchi; Ting, Daniel S W; Watkinson, Peter; Weber, Wim; Wheatstone, Peter; McCulloch, Peter
• Other Names: author non-byline.; Lee Aaron Y author non-byline.; Fraser Alan G author non-byline.; Connell Ali author non-byline.; Vira Alykhan author non-byline.; Esteva Andre author non-byline.; Althouse Andrew D author non-byline.; Beam Andrew L author non-byline.; de Hond Anne author non-byline.; Boulesteix Anne-Laure author non-byline.; Bradlow Anthony author non-byline.; Ercole Ari author non-byline.; Paez Arsenio author non-byline.; Tsanas Athanasios author non-byline.; Kirby Barry author non-byline.; Glocker Ben author non-byline.; Velardo Carmelo author non-byline.; Park Chang Min author non-byline.; Hehakaya Charisma author non-byline.; Baber Chris author non-byline.; Paton Chris author non-byline.; Johner Christian author non-byline.; Kelly Christopher J author non-byline.; Vincent Christopher J author non-byline.; Yau Christopher author non-byline.; McGenity Clare author non-byline.; Gatsonis Constantine author non-byline.; Faivre-Finn Corinne author non-byline.; Simon Crispin author non-byline.; Sent Danielle author non-byline.; Bzdok Danilo author non-byline.; Treanor Darren author non-byline.; Wong David C author non-byline.; Steiner David F author non-byline.; Higgins David author non-byline.; Benson Dawn author non-byline.; O'Regan Declan P author non-byline.; Gunasekaran Dinesh V author non-byline.; Danks Dominic author non-byline.; Neri Emanuele author non-byline.; Kyrimi Evangelia author non-byline.; Schwendicke Falk author non-byline.; Magrabi Farah author non-byline.; Ives Frances author non-byline.; Rademakers Frank E author non-byline.; Fowler George E author non-byline.; Frau Giuseppe author non-byline.; Hogg H D Jeffry author non-byline.; Marcus Hani J author non-byline.; Chan Heang-Ping author non-byline.; Xiang Henry author non-byline.; McIntyre Hugh F author non-byline.; Harvey Hugh author non-byline.; Kim Hyungjin author non-byline.; Habli Ibrahim author non-byline.; Fackler James C author non-byline.; Shaw James author non-byline.; Higham Janet author non-byline.; Wohlgemut Jared M author non-byline.; Chong Jaron author non-byline.; Bibault Jean-Emmanuel author non-byline.; Cohen Jérémie F author non-byline.; Kers Jesper author non-byline.; Morley Jessica author non-byline.; Krois Joachim author non-byline.; Monteiro Joao author non-byline.; Horovitz Joel author non-byline.; Fletcher John author non-byline.; Taylor Jonathan author non-byline.; Yoon Jung Hyun author non-byline.; Singh Karandeep author non-byline.; Moons Karel G M author non-byline.; Karpathakis Kassandra author non-byline.; Catchpole Ken author non-byline.; Hood Kerenza author non-byline.; Balaskas Konstantinos author non-byline.; Kamnitsas Konstantinos author non-byline.; Militello Laura author non-byline.; Wynants Laure author non-byline.; Oakden-Rayner Lauren author non-byline.; Lovat Laurence B author non-byline.; Smits Luc J M author non-byline.; Hinske Ludwig C author non-byline.; ElZarrad M Khair author non-byline.; van Smeden Maarten author non-byline.; Giavina-Bianchi Mara author non-byline.; Daley Mark author non-byline.; Sendak Mark P author non-byline.; Sujan Mark author non-byline.; Rovers Maroeska author non-byline.; DeCamp Matthew author non-byline.; Woodward Matthew author non-byline.; Komorowski Matthieu author non-byline.; Marsden Max author non-byline.; Mackintosh Maxine author non-byline.; Abramoff Michael D author non-byline.; Armengol de la Hoz Miguel Ángel author non-byline.; Hambidge Neale author non-byline.; Daly Neil author non-byline.; Peek Niels author non-byline.; Redfern Oliver author non-byline.; Ahmad Omer F author non-byline.; Bossuyt Patrick M author non-byline.; Keane Pearse A author non-byline.; Ferreira Pedro N P author non-byline.; Schnell-Inderst Petra author non-byline.; Mascagni Pietro author non-byline.; Dasgupta Prokar author non-byline.; Guan Pujun author non-byline.; Barnett Rachel author non-byline.; Kader Rawen author non-byline.; Chopra Reena author non-byline.; Mann Ritse M author non-byline.; Sarkar Rupa author non-byline.; Mäenpää Saana M author non-byline.; Finlayson Samuel G author non-byline.; Vollam Sarah author non-byline.; Vollmer Sebastian J author non-byline.; Park Seong Ho author non-byline.; Laher Shakir author non-byline.; Joshi Shalmali author non-byline.; van der Meijden Siri L author non-byline.; Shelmerdine Susan C author non-byline.; Tan Tien-En author non-byline.; Stocker Tom JW author non-byline.; Giannini Valentina author non-byline.; Madai Vince I author non-byline.; Newcombe Virginia author non-byline.; Ng Wei Yan author non-byline.; Rogers Wendy A author non-byline.; Ogallo William author non-byline.; Park Yoonyoung author non-byline.; Perkins Zane B author non-byline.;
• Is Part Of: BMJ. Volume 377(2022)
• Publication Date: 2022-05-18
• Subjects: Medicine -- Periodicals; Medicine -- Periodicals; Medicine; Periodicals; 610
• DOI: 10.1136/bmj-2022-070904
• Languages: English
• ISSNs: 0007-1447

Abstract

Abstract : A growing number of artificial intelligence (AI)-based clinical decision support systems are showing promising performance in preclinical, in silico, evaluation, but few have yet demonstrated real benefit to patient care. Early stage clinical evaluation is important to assess an AI system's actual clinical performance at small scale, ensure its safety, evaluate the human factors surrounding its use, and pave the way to further large scale trials. However, the reporting of these early studies remains inadequate. The present statement provides a multistakeholder, consensus-based reporting guideline for the Developmental and Exploratory Clinical Investigations of DEcision support systems driven by Artificial Intelligence (DECIDE-AI). We conducted a two round, modified Delphi process to collect and analyse expert opinion on the reporting of early clinical evaluation of AI systems. Experts were recruited from 20 predefined stakeholder categories. The final composition and wording of the guideline was determined at a virtual consensus meeting. The checklist and the Explanation & Elaboration (E&E) sections were refined based on feedback from a qualitative evaluation process. 123 experts participated in the first round of Delphi, 138 in the second, 16 in the consensus meeting, and 16 in the qualitative evaluation. The DECIDE-AI reporting guideline comprises 17 AI specific reporting items (made of 28 subitems) and 10 generic reporting items, with an E&E paragraph provided for each. Through consultation and consensus with a range of stakeholders, we have developed a guideline comprising key items that should be reported in early stage clinical studies of AI-based decision support systems in healthcare. By providing an actionable checklist of minimal reporting items, the DECIDE-AI guideline will facilitate the appraisal of these studies and replicability of their findings.