Methodologic Standards for Diagnostic Test Research in Pulmonary Medicine: Study Rating

In: Pulmonary Medicine

28 Jun 2014

Methodologic Standards for Diagnostic Test Research in Pulmonary Medicine: Study RatingStudy Rating
The articles were rated independently by two of the investigators for adherence to the methodologic and data analysis standards. Disagreements between the two observers for individual standards were resolved with an independent review by a third investigator. The majority opinion was selected as the final rating. The investigators were provided a data collection sheet that defined the standards and provided criteria for determining if a standard was fulfilled. The raters reviewed articles on assessment of diagnostic research’ and discussed the study standards before beginning evaluation of the articles. The raters also determined whether an article recommended use of the diagnostic test or made a statement that additional studies were required before the test should be introduced into clinical practice. Click Here They also assessed whether articles identified and discussed their major methodologic flaws and the flaws’ potential impact on conclusions.
Data Analysis
Study rater variability was measured using the kappa statistic. Degrees of agreement were categorized by the kappa values as follows: <0 “poor” agreement, 0 to 0.2 “slight” agreement, 0.2 to 0.4 “fair” agreement, 0.4 to 0.6 “moderate” agreement, 0.6 to 0.8 “substantial” agreement, and 0.8 to 1.0 “almost perfect” agreement. Group comparisons for categorical results were made with X2 analysis or the Fisher Exact Test where appropriate. Kruskall-Wallis rank sums test was used to compare the adherence to study design standards of the general vs specialty journals. Descriptive and analytic statistics were generated using software (JMP; SAS Institute; Caiy, NC) with a computer (Macintosh; Apple Computers; Cupertino, Calif).
Table 1 shows the type of diagnostic tests evaluated by the 41 study articles. Twenty-nine (71%) of the 41 articles were prospective cohort designs, 11 (27%) were retrospective cohort designs, and 1 (2%) was a case-control study. Among the 40 cohort studies, the diagnostic test always preceded the reference standard procedure in 27 studies and the diagnostic test was sometimes before and sometimes after the reference standard in 13 studies. The case-control study had a design by which the reference standard procedure was performed before the diagnostic test.
Table 1—Types of Diagnostic Tests Evaluated by the Study Articles

Type of Test No. (%)
Imaging 16 (39)
Impedence plethysmography (IPG)
IPG and real-time compression ultrasonography
Nonvascular ultrasonography
Positron emission tomography
Standard radiographs
Transesophageal echocardiography
Immunoassays 5(12)
Biochemical test 4(10)
Genetics test 4(10)
Diagnostic procedure—bronchoscopy 8(20)
Miscellaneous 4(10)

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