BACKGROUND: In drug development, a 4-phase hierarchical model for the clinical evaluation of new pharmaceuticals is well known. Several comparable phased evaluation schemes have been proposed for medical tests. PURPOSE: To perform a systematic search of the literature, a synthesis, and a critical review of phased evaluation schemes for medical tests. DATA SOURCES: Literature databases of Medline, Web of Science, and Embase. STUDY SELECTION AND DATA EXTRACTION: Two authors separately evaluated potentially eligible papers and independently extracted data. RESULTS: We identified 19 schemes, published between 1978 and 2007. Despite their variability, these models show substantial similarity. Common phases are evaluations of technical efficacy, diagnostic accuracy, diagnostic thinking efficacy, therapeutic efficacy, patient outcome, and societal aspects. CONCLUSIONS: The evaluation frameworks can be useful to distinguish between study types, but they cannot be seen as a necessary sequence of evaluations. The evaluation of tests is most likely not a linear but a cyclic and repetitive process.
BACKGROUND: In drug development, a 4-phase hierarchical model for the clinical evaluation of new pharmaceuticals is well known. Several comparable phased evaluation schemes have been proposed for medical tests. PURPOSE: To perform a systematic search of the literature, a synthesis, and a critical review of phased evaluation schemes for medical tests. DATA SOURCES: Literature databases of Medline, Web of Science, and Embase. STUDY SELECTION AND DATA EXTRACTION: Two authors separately evaluated potentially eligible papers and independently extracted data. RESULTS: We identified 19 schemes, published between 1978 and 2007. Despite their variability, these models show substantial similarity. Common phases are evaluations of technical efficacy, diagnostic accuracy, diagnostic thinking efficacy, therapeutic efficacy, patient outcome, and societal aspects. CONCLUSIONS: The evaluation frameworks can be useful to distinguish between study types, but they cannot be seen as a necessary sequence of evaluations. The evaluation of tests is most likely not a linear but a cyclic and repetitive process.
Authors: Marcel Adler; Sandra Ivic; Nicolas S Bodmer; Hugo Ten Cate; Lucas M Bachmann; Walter A Wuillemin; Michael Nagler Journal: Transfus Med Hemother Date: 2017-03-08 Impact factor: 3.747
Authors: Chad V Pecot; Ming Li; Xueqiong J Zhang; Rama Rajanbabu; Ciara Calitri; Aaron Bungum; James R Jett; Joe B Putnam; Carol Callaway-Lane; Steve Deppen; Eric L Grogan; David P Carbone; John A Worrell; Karel G M Moons; Yu Shyr; Pierre P Massion Journal: Cancer Epidemiol Biomarkers Prev Date: 2012-02-28 Impact factor: 4.254
Authors: Paul K Drain; Emily P Hyle; Farzad Noubary; Kenneth A Freedberg; Douglas Wilson; William R Bishai; William Rodriguez; Ingrid V Bassett Journal: Lancet Infect Dis Date: 2013-12-10 Impact factor: 25.071
Authors: Monica L Zigman Suchsland; Elizabeth Witwer; Anjali R Truitt; Danielle C Lavallee; Ying Zhang; Philip Posner; Brian Do; Patrick M Bossuyt; Victoria Hardy; Matthew J Thompson Journal: J Am Coll Radiol Date: 2018-10-25 Impact factor: 5.532
Authors: Marjolein M N Leeuwenburgh; Wytze Laméris; Adrienne van Randen; Patrick M M Bossuyt; Marja A Boermeester; Jaap Stoker Journal: BMC Emerg Med Date: 2010-10-20
Authors: Piotr Lewczuk; Peter Riederer; Sid E O'Bryant; Marcel M Verbeek; Bruno Dubois; Pieter Jelle Visser; Kurt A Jellinger; Sebastiaan Engelborghs; Alfredo Ramirez; Lucilla Parnetti; Clifford R Jack; Charlotte E Teunissen; Harald Hampel; Alberto Lleó; Frank Jessen; Lidia Glodzik; Mony J de Leon; Anne M Fagan; José Luis Molinuevo; Willemijn J Jansen; Bengt Winblad; Leslie M Shaw; Ulf Andreasson; Markus Otto; Brit Mollenhauer; Jens Wiltfang; Martin R Turner; Inga Zerr; Ron Handels; Alexander G Thompson; Gunilla Johansson; Natalia Ermann; John Q Trojanowski; Ilker Karaca; Holger Wagner; Patrick Oeckl; Linda van Waalwijk van Doorn; Maria Bjerke; Dimitrios Kapogiannis; H Bea Kuiperij; Lucia Farotti; Yi Li; Brian A Gordon; Stéphane Epelbaum; Stephanie J B Vos; Catharina J M Klijn; William E Van Nostrand; Carolina Minguillon; Matthias Schmitz; Carla Gallo; Andrea Lopez Mato; Florence Thibaut; Simone Lista; Daniel Alcolea; Henrik Zetterberg; Kaj Blennow; Johannes Kornhuber Journal: World J Biol Psychiatry Date: 2017-10-27 Impact factor: 4.132