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Table 1 The STARD 2015 list

From: Updating standards for reporting diagnostic accuracy: the development of STARD 2015

Section and topic No. Item
Title or abstract
  1 Identification as a study of diagnostic accuracy using at least one measure of accuracy (such as sensitivity, specificity, predictive values, or AUC)
Abstract
  2 Structured summary of study design, methods, results, and conclusions (for specific guidance, see STARD for Abstracts)
Introduction
  3 Scientific and clinical background, including the intended use and clinical role of the index test
  4 Study objectives and hypotheses
Methods
 Study design 5 Whether data collection was planned before the index test and reference standard were performed (prospective study) or after (retrospective study)
 Participants 6 Eligibility criteria
  7 On what basis potentially eligible participants were identified (such as symptoms, results from previous tests, inclusion in registry)
  8 Where and when potentially eligible participants were identified (setting, location, and dates)
  9 Whether participants formed a consecutive, random, or convenience series
 Test methods 10a Index test, in sufficient detail to allow replication
  10b Reference standard, in sufficient detail to allow replication
  11 Rationale for choosing the reference standard (if alternatives exist)
  12a Definition of and rationale for test positivity cutoffs or result categories of the index test, distinguishing pre-specified from exploratory
  12b Definition of and rationale for test positivity cutoffs or result categories of the reference standard, distinguishing pre-specified from exploratory
  13a Whether clinical information and reference standard results were available to the performers or readers of the index test
  13b Whether clinical information and index test results were available to the assessors of the reference standard
 Analysis 14 Methods for estimating or comparing measures of diagnostic accuracy
  15 How indeterminate index test or reference standard results were handled
  16 How missing data on the index test and reference standard were handled
  17 Any analyses of variability in diagnostic accuracy, distinguishing pre-specified from exploratory
  18 Intended sample size and how it was determined
Results
 Participants 19 Flow of participants, using a diagram
  20 Baseline demographic and clinical characteristics of participants
  21a Distribution of severity of disease in those with the target condition
  21b Distribution of alternative diagnoses in those without the target condition
  22 Time interval and any clinical interventions between index test and reference standard
 Test results 23 Cross tabulation of the index test results (or their distribution) by the results of the reference standard
  24 Estimates of diagnostic accuracy and their precision (such as 95 % confidence intervals)
  25 Any adverse events from performing the index test or the reference standard
Discussion
  26 Study limitations, including sources of potential bias, statistical uncertainty, and generalizability
  27 Implications for practice, including the intended use and clinical role of the index test
Other information
  28 Registration number and name of registry
  29 Where the full study protocol can be accessed
  30 Sources of funding and other support; role of funders