Diagnostic Test Accuracy Studies in Dementia A Pragmatic Approach A.J. Larner 123 Diagnostic Test Accuracy Studies in Dementia A.J. Larner Diagnostic Test Accuracy Studies in Dementia A Pragmatic Approach A.J. Larner Cognitive Function Clinic Walton Centre for Neurology and Neurosurgery Liverpool UK ISBN 978-3-319-16696-4 ISBN 978-3-319-16697-1 (eBook) DOI 10.1007/978-3-319-16697-1 Library of Congress Control Number: 2015937383 Springer Cham Heidelberg New York Dordrecht London © Springer International Publishing Switzerland 2015 T his work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifi cally the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfi lms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. T he use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specifi c statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. T he publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. Printed on acid-free paper S pringer International Publishing AG Switzerland is part of Springer Science+Business Media (www.springer.com) To Martin Loyal cousin; dedicated healthcare professional Pref ace T his book has evolved from more than a decade of personal experience in conducting diagnostic test accuracy studies of clinical signs and cognitive and non- cognitive screening instruments in a dedicated cognitive disorders clinic. Many of these studies have been published, and are summarised elsewhere (Larner 2014a, b). T he ageing of the human population with the consequent increase in numbers of individuals affl icted with cognitive impairment and dementia mandates diagnostic test accuracy studies to identify and eventually treat these patients effectively. If, as seems likely, population based testing for early identifi cation becomes the future policy norm, the requirement for tests with established high diagnostic test accuracy is self-evident. A rigorous methodology developed to generate meaningful data from such studies is therefore an imperative need. A s well as giving a general overview, the book gives particular emphasis to, and argues in favour of, what I have previously termed “pragmatic diagnostic accuracy studies” (Larner 2012a, 2014a: 33–5). This methodology seems to me to correspond largely with Sackett and Haynes’ (2002) nomenclature of addressing a “Phase III question”, i.e. among patients in whom it is clinically sensible to suspect the target disorder, does the test result distinguish those with and without the target disorder? Consecutive patients should be studied to answer such questions, and hence this approach, with certain limitations, would seem to fi t very well with the idiom of day-to-day clinical practice. Hence, such pragmatic diagnostic test accuracy stud- ies, far from being the preserve of large, well-funded, often international, collabora- tive groups comprised of an intellectual elite (as for most randomised controlled trials), may fall relatively easily within the ambit or compass of jobbing work-a-day clinicians (like myself), a phenomenon which I have elsewhere ventured to term “micro-research” (Larner 2012b: xv). It is hoped that a brief exposition on some of the practicalities of pragmatic diagnostic test accuracy studies will encourage read- ers as to their feasibility without the necessity for a large research infrastructure or funding, and hence to identify suitable research questions and undertake the appro- priate empirical studies. No in-depth mathematical expertise is required for the application of the few equations found in the text (moreover, statistical programmes are also available), nor any familiarity with probability theory, for which reason vii viii Preface probability notation is eschewed. Lest a discourse on method be deemed too arid, the text is leavened with some examples taken from the literature on diagnostic studies in dementia. T he book is structured as for a research publication, i.e. Introduction, Methods, Results, Discussion, with a few digressions where necessary. Since methodology is paramount, this of necessity comprises the longest overall section of the book (Chaps. 2 and 3 ). The chosen structure also follows the published guidelines for the assessment of the quality of studies examining the diagnostic accuracy of clinical tests, such as the Standards for Reporting Diagnostic Accuracy (STARD; Bossuyt et al. 2003) and the Quality Assessment of Diagnostic Accuracy Studies (QUADAS and QUADAS-2; Whiting et al. 2004, 2011). More recently, STARD guidelines for reporting diagnostic test accuracy studies in dementia (STARDdem) have emerged from the Cochrane Dementia and Cognitive Improvement Group (Noel-Storr et al. 2014), so this is an apposite moment to produce a book-length treatment of these issues as related to dementia practice. However, the content here is rather more discursive, and perhaps less prescriptive, than in the aforementioned guidelines, refl ective of individual practice. Readers will (hopefully) therefore be helped to negotiate the sometimes bumpy path between the aspirations of principles and the messy realities of practice, and therefore be able to be “doing science” in some sense without being superfi cialist. Studies examining cognitive screening instru- ments are particularly emphasized, refl ecting the author’s area of particular interest (greater detail on some of the instruments examined may be accessed elsewhere: Larner 2013), but as the detection of disease biomarkers has become of increasing importance to diagnosis, as refl ected in more recent sets of diagnostic criteria for neurodegenerative disorders, these too will be considered. A lthough the focus of this book is dementia and cognitive disorders, the approach described may be applicable not only to other areas of neurological practice but also of medicine and even surgery. Liverpool, UK A. J. Larner References Bossuyt PM, Reitsma JB, Bruns DE, et al. The STARD statement for reporting studies of diagnos- tic accuracy: explanation and elaboration. Clin Chem. 2003;49:7–18. L arner AJ. Pragmatic diagnostic accuracy studies. h ttp://bmj.com/content/345/bmj.e3999?tab=responses . 28 August 2012a. L arner AJ. Dementia in clinical practice: a neurological perspective. Studies in the dementia clinic. London: Springer; 2012b. Larner AJ (ed.). Cognitive screening instruments. A practical approach. London: Springer; 2013. Larner AJ. Dementia in clinical practice: a neurological perspective. Pragmatic studies in the cognitive function clinic. (2nd edition). London: Springer; 2014a. Larner AJ. Neurological signs of possible diagnostic value in the cognitive disorders clinic. Pract Neurol. 2014b;14:332–5. Noel-Storr AH, McCleery JM, Richard E, et al. Reporting standards for studies of diagnostic test accuracy in dementia: the STARDdem Initiative. Neurology. 2014;83:364–73. Preface ix Sackett DL, Haynes RB. The architecture of diagnostic research. In: Knottnerus JA, editor. The evidence base of clinical diagnosis. London: BMJ Books; 2002. p. 19–38. Whiting P, Rutjes AW, Dinnes J, Reitsma J, Bossuyt PM, Kleijnen J. Development and validation of methods for assessing the quality of diagnostic accuracy studies. Health Technol Assess. 2004;8:iii, 1–234. Whiting PF, Rutjes AW, Westwood ME, et al. QUADAS-2: a revised tool for the quality assess- ment of diagnostic accuracy studies. Ann Intern Med. 2011;155:529–36.
Description: