STARD⇒QUADASの対応Section and Topic Item On page # #TITLE/ABSTRACT/ 1 Identify the article as a study of diagnostic accuracy (recommend MeSHKEYWORDS heading sensitivity and specificity).INTRODUCTION 2 State the research questions or study aims, such as estimating diagnostic accuracy or comparing accuracy between tests or across participant groups.METHODS Participants 3 The study population: The inclusion and exclusion criteria, setting and Q1, Q2 locations where data were collected. 4 Participant recruitment: Was recruitment based on presenting symptoms, results from previous tests, or the fact that the participants had received the index tests Q1 or the reference standard? 5 Participant sampling: Was the study population a consecutive series of participants defined by the selection criteria in item 3 and 4? If not, specify Q2 how participants were further selected. 6 Data collection: Was data collection planned before the index test and reference standard were performed (prospective study) or after (retrospective study)? Test methods 7 The reference standard and its rationale. Q3 8 Technical specifications of material and methods involved including how and when measurements were taken, and/or cite references for index tests and Q8, 9 reference standard. 9 Definition of and rationale for the units, cut-offs and/or categories of the results of the index tests and the reference standard. Q7 10 The number, training and expertise of the persons executing and reading the index tests and the reference standard. 11 Whether or not the readers of the index tests and reference standard were blind (masked) to the results of the other test and describe any other clinical Q10, 11, information available to the readers. 12 Statistical methods 12 Methods for calculating or comparing measures of diagnostic accuracy, and the statistical methods used to quantify uncertainty (e.g. 95% confidence intervals). 13 Methods for calculating test reproducibility, if done.
STARD⇒QUADASの対応RESULTS Participants 14 When study was performed, including beginning and end dates of recruitment. 15 Clinical and demographic characteristics of the study population (at least information on age, gender, spectrum of presenting symptoms). Q1 16 The number of participants satisfying the criteria for inclusion who did or did not undergo the index tests and/or the reference standard; describe why participants Q13,14 failed to undergo either test (a flow diagram is strongly recommended). Q5, Q6 Test results 17 Time-interval between the index tests and the reference standard, and any treatment administered in between. Q4 18 Distribution of severity of disease (define criteria) in those with the target condition; other diagnoses in participants without the target condition. Q1 19 A cross tabulation of the results of the index tests (including indeterminate and missing results) by the results of the reference standard; for continuous results, the distribution of the test results by the results of the reference standard. 20 Any adverse events from performing the index tests or the reference standard. Q13 Estimates 21 Estimates of diagnostic accuracy and measures of statistical uncertainty (e.g. 95% confidence intervals). 22 How indeterminate results, missing data and outliers of the index tests were handled. Q13 23 Estimates of variability of diagnostic accuracy between subgroups of participants, readers or centers, if done. 24 Estimates of test reproducibility, if done.DISCUSSION 25 Discuss the clinical applicability of the study findings.
引用文献Benyamin et al. (in press). Childhood intelligence is heritable, highly polygenic and associated with FNBP1L. Mol Psyhiatry. http://www.nature.com/mp/journal/vaop/ncurrent/full/mp2012184a.htmlBianchi et al. (2012). Genome-wide fetal aneuploidy detection by maternal plasma DNA sequencing. Obstet Gynecol, 119, 890-901.Bossuyt et al. (2003) The STARD statement for reporting studies of diagnostic accuracy: Explanation and elaboration. Ann Intern Med, 138, W1- W12.Devers et al. (in press). Noninvasive prenatal testing/noninvasive prenatal diagnosis: the position of the National Society of Genetic Counselors. J Genet Couns. http://link.springer.com/article/10.1007/s10897-012-9564-0Greely (2011). Get ready for the flood of fetal gene screening. Nature, 469, 289–291.Hayden (2011). Fetal gene screening comes to market. Nature, 478, 440. Nature, 469, 289–291.Fan et al. (2012). Non-invasive prenatal measurement of the fetal genome. Nature, 487, 320–326.Lijmer et al. (1999) Empirical evidence of design-related bias in studies of diagnostic tests. JAMA, 282, 1061-1066.Lucas et al. (2010) The development of quality appraisal tool for studies of diagnostic accuracy. J Clin Epidemiol, 63, 854-861.Mansfield et al. (1999). Termination rates after prenatal diagnosis of Down syndrome, spina bifida, anencephaly, and Turner and Klinefelter syndromes: a systematic literature review. Prenat Diagn, 19, 808-12.Palomaki et al. (2011). DNA sequencing of maternal plasma to detect Down syndrome: An international clinical validation study. Genet Med, 13, 913-20.Palomaki et al. (2012). DN A sequencing of maternal plasma reliably identifies trisomy 18 and trisomy 13 as well as Down syndrome: an international collaborative study. Genet Med, 14, 296-305.Skotko (2009). With new prenatal testing, will babies with Down syndrome slowly disappear? Arch Dis Child, 94, 823-826.Skotko (2011). Self-perceptions from people with Down syndrome. Am J Med Genet Part A, 155, 2360-2369.Skotko et al. (2011). Having a son or daughter with Down syndrome: perspectives from mothers and fathers. Am J Med Genet Part A, 155, 2335- 2347.Streiner (2003). Diagnosing tests: using and misusing diagnostic and screening tests. J Pers Assess, 81, 209-219.鈴木貞夫 (2006). 診断検査の正確さの評価と比較 現代医学，53，513-518.Verweij et al. (2012). Diagnostic accuracy of noninvasive detection of fetal trisomy 21 in maternal blood: A systematic review. Fetal Diagn Ther, 31, 81-86.Whiting et al. (2003) The development of QUADAS: A tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol, Nov 10, 3-25.Whiting et al. (2004) Sources of variation and bias in studies of diagnostic accuracy. Ann Intern Med, 140, 189-202.Whiting et al. (2011) QUADAS-2: A revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med, 155, 529-536.