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Table 4 Definition of the four components used to assess the description of test-treatment interventions, with examples of adequate descriptions

From: Research waste in diagnostic trials: a methods review evaluating the reporting of test-treatment interventions


Definition and example

1. Diagnostic test:

Technique used to perform the test. Reporting the name of the test only was considered insufficient.

e.g., “Radiographs of the knee were obtained in the lateral and anteroposterior projection and were supplemented with patellar or tunnel views if pathologic abnormalities of the patellofemoral joint or intercondylar notch were suspected” [33].

2. Diagnostic decision:

Description of the operational criteria used for arriving at a particular diagnosis using the test results.

e.g., “If the lung scan showed no abnormalities, pulmonary embolism was excluded; if there were 1 or more segmental perfusion defects that were normally ventilated, the scan was considered diagnostic for pulmonary embolism (“high-probability scan”); and if there were perfusion defects that did not meet criteria for a “high-probability scan,” the scan was considered nondiagnostic” [34].

3. Management decision:

Description of how treatments were selected as a result of the diagnosis.

e.g., “Patients in group A1 and group A2 with H. pylori sensitive to AMO and LEV were treated with AMO (1 g b.i.d.), LEV (500 mg b.i.d.), and ESO (esomeprazole) (20 mg b.i.d.) for 10 days. If H. pylori was found resistant to AMO and/or LEV the treatment was based on the indications of the susceptibility test. Patients enrolled in group B1 and group B2 were treated empirically, that is without performing the H. pylori susceptibility to various antibiotics, with a standard treatment that included AMO (1 g b.i.d.), LEV (500 mg b.i.d.), and ESO (20 mg b.i.d.) for 10 days” [35].

4. Treatment:

Description of how selected treatments were administered. Reporting of the treatment name only was considered insufficient.

e.g., “After ultrasound diagnosis of an anal sphincter tear… women were brought immediately to the operating room to provide appropriate lighting, instruments, and assistants and underwent a surgical exploration of the perineum by the obstetrician-in-charge under senior supervision. The anal sphincter was exposed and its integrity assessed by inspection and palpation. The ends of the sphincter were approximated end-to-end with 2–0 monofilament polyglyconate sutures (Maxon, Sherwood Davis & Geck, St. Louis, MO). Postoperatively, women received dietary advice to avoid constipation, with occasional use of stool softeners. For women allocated to the control group, the obstetrician sutured the perineum after clinical examination” [36].