TITLE/ABSTRACT
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Identify the article as a study concerning a measuring instrument.
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INTRODUC-TON
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State the research questions or study aims, like developing or validating a measuring instrument.
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METHODS
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Participants
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Describe the study population: The inclusion and exclusion criteria, setting and locations where the data were collected.
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Describe the method of recruitment of the participants.
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Describe participant sampling: Was the study population a consecutive series of participants defined by the selection criteria in items 3 and 4? If not, specify how participants were further selected.
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Describe data collection: Was data collection planned before the use of the measuring instrument?
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Test methods
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Describe the reference standard criterion validity and its rationale.
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Describe technical specifications of material and methods involved including how and when measurements were taken, and/or cite references for measuring instrument.
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Describe definition of and rationale for the units, cut-offs and/or categories of the results of the instrument and the reference standard.
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Describe the number, training and expertise of the persons executing and reading the measuring instrument and the reference standard.
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Describe other tests or relevant information for the readers concerning the measuring instrument (subjective).
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Statistical methods
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Describe methods for calculating or comparing measures of reliability, validity, and the statistical methods used to quantify uncertainty (e.g. 95% confidence intervals)
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Describe methods for calculating test reproducibility, if done.
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Describe a method that takes into account non-independence of data (if applicable)
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RESULTS
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Participants
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Report when study was done, including beginning and ending dates of recruitment.
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Report demographic characteristics of the study population (e.g. age, sex, employment, recruitment centers).
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Report the number of participants satisfying the criteria for inclusion (a flow diagram is strongly recommended).
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Test results
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Report time interval from the measuring instrument to the reference standard, and any measures administered in between.
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Report distribution of severity of the situation being assessed (define criteria) in those with the target condition; other diagnoses in participants without the target condition
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Report a cross tabulation of the results of the measuring instrument (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
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Report any adverse events from performing the measuring instrument or the reference standard
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Estimates
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Report estimates of accuracy and measures of statistical uncertainty (e.g. 95% confidence intervals).
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Report how indeterminate results, missing responses and outliers of the measuring instrument were handled.
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Report estimates of variability of accuracy between groups of participants, if done.
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Report estimates of test reproducibility, if done.
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DISCUSSION
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Discuss the clinical applicability of the study findings.
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| |
11/26
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11/26
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11/26
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16/26
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11/26
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13/26
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15/26
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18/26
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15/26
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2/26*
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14/26
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