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BACKGROUND: Imaging tests are one of the most frequently used diagnostic modalities in healthcare, but the benefits of their direct impacts on clinical decision-making have been countered by concerns that they can be overused. Assessing the relative value of imaging tests has largely focused on measures of test accuracy, which overlooks more comprehensive benefits and risks of imaging tests, particularly their impact on patient-centred outcomes (PCOs). We present the findings of the Patient Reported Outcomes of Diagnostics (PROD) research study in response to a methodological gap in the area of diagnostic test comparative effectiveness research. METHODS: Over a 3-year period, the PROD Study engaged with multiple stakeholders to identify existing conceptual models related to PCOs for imaging testing, conducted primary research and evidence synthesis, and developed consensus recommendations to describe and categorise PCOs related to imaging testing. RESULTS: The PROD framework categorises PCOs from imaging studies within four main domains: information or knowledge yielded, physical impact, emotional outcomes and test burden. PCOs interact with each other and influence effects across domains, and can be modified by factors related to the patient, clinical situation, healthcare team and the testing environment. CONCLUSIONS: Using PCOs to inform healthcare decision-making will require ways of collating and presenting information on PCOs in ways that can inform patient-provider decision-making, and developing methods to determine the relative importance of outcomes (including test accuracy) to one another.

BACKGROUND: Low back pain is a common presentation across different healthcare settings. Clinicians need to confidently be able to screen and identify people presenting with low back pain with a high suspicion of serious or specific pathology (e.g. vertebral fracture). Patients identified with an increased likelihood of having a serious pathology will likely require additional investigations and specific treatment. Guidelines recommend a thorough history and clinical assessment to screen for serious pathology as a cause of low back pain. However, the diagnostic accuracy of recommended red flags (e.g. older age, trauma, corticosteroid use) remains unclear, particularly those used to screen for vertebral fracture. OBJECTIVES: To assess the diagnostic accuracy of red flags used to screen for vertebral fracture in people presenting with low back pain. Where possible, we reported results of red flags separately for different types of vertebral fracture (i.e. acute osteoporotic vertebral compression fracture, vertebral traumatic fracture, vertebral stress fracture, unspecified vertebral fracture). SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 26 July 2022. SELECTION CRITERIA: We considered primary diagnostic studies if they compared results of history taking or physical examination (or both) findings (index test) with a reference standard test (e.g. X-ray, magnetic resonance imaging (MRI), computed tomography (CT), single-photon emission computerised tomography (SPECT)) for the identification of vertebral fracture in people presenting with low back pain. We included index tests that were presented individually or as part of a combination of tests. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data for diagnostic two-by-two tables from the publications or reconstructed them using information from relevant parameters to calculate sensitivity, specificity, and positive (+LR) and negative (-LR) likel

Objectives: This is a protocol for a Cochrane Review (diagnostic). The objectives are as follows:. The objective of this review is to assess the diagnostic accuracy of red flags used to screen for vertebral fracture in patients presenting with low back pain. Where possible, we will report the results of red flags separately for different types of vertebral fracture as follows. Osteoporotic vertebral compression fracture Vertebral traumatic fracture Vertebral stress fracture. Secondary objectives The secondary objective of this review is to assess the influence of sources of heterogeneity on the diagnostic accuracy of red flag tests, if appropriate. In particular, we will assess the healthcare setting (e.g. primary, emergency, or secondary care) and the different types of vertebral fracture (i.e. osteoporotic vertebral compression fracture, vertebral traumatic fracture, and vertebral stress fracture. We will also assess mean age at different cut-off thresholds (e.g. > 50 years of age versus > 70 years of age) across different studies, as this has previously been shown to influence results.

Objectives: This is a protocol for a Cochrane Review (diagnostic). The objectives are as follows:. The objective of this review is to assess the diagnostic accuracy of red flags used to screen for vertebral fracture in patients presenting with low back pain. Where possible, we will report the results of red flags separately for different types of vertebral fracture as follows. Osteoporotic vertebral compression fracture Vertebral traumatic fracture Vertebral stress fracture. Secondary objectives The secondary objective of this review is to assess the influence of sources of heterogeneity on the diagnostic accuracy of red flag tests, if appropriate. In particular, we will assess the healthcare setting (e.g. primary, emergency, or secondary care) and the different types of vertebral fracture (i.e. osteoporotic vertebral compression fracture, vertebral traumatic fracture, and vertebral stress fracture. We will also assess mean age at different cut-off thresholds (e.g. > 50 years of age versus > 70 years of age) across different studies, as this has previously been shown to influence results.