The proposed HTA will address the following research questions. Details on the specific interventions and outcomes are included in Table 1.
Clinical
To acknowledge the order of assessment in the diagnostic pathway (note: a diagnostic pathway is defined for this report as a specific and deliberate sequence of assessments comprising strategies for initial risk stratification and ultimate determination of disease positivity. This is distinct from the use of the term “diagnostic imaging studies,” which applies only to CT, magnetic resonance imaging [MRI], V/Q, PET-CT, and thoracic ultrasound-based studies used to diagnose PE) for PE, the clinical research questions are ordered by intervention, starting with risk stratification strategies, and followed by complete diagnostic pathways and diagnostic imaging studies. This does not reflect the priority of the research questions.
Risk Stratification Strategies
- 1.
What are the A) diagnostic test accuracy, B) comparative clinical utility, and C) safety of Wells or Geneva clinical prediction rules for the risk stratification of adult patients presenting with PE symptoms in urban, rural, and remote settings:
with or without the use of PERC
with or without the use of D-dimer testing
with or without the use of other biochemical or imaging risk stratification strategies?
Diagnostic Pathways and Diagnostic Imaging Studies
- 2.
What are the A) diagnostic test accuracy, B) comparative clinical utility, and C) safety of diagnostic pathways including imaging studies for the diagnosis of PE in adult patients in urban, rural, and remote settings?
- 3.
What are the A) diagnostic test accuracy, B) comparative clinical utility, and C) safety of imaging studies for the diagnosis of PE in adult patients in urban, rural, and remote settings?
Cost-Effectiveness
- 4.
What is the cost-effectiveness of diagnostic pathways, including imaging studies, to test adult patients suspected of PE?
Patient Experiences and Perspectives
- 5.
What are the experiences with the diagnostic process from the perspective of those who have undergone testing for acute PE, as well as their family members and non-clinical caregivers?
- 6.
What are the experiences with diagnostic imaging technologies for hematological, pulmonary, or cardiac conditions from the perspective of patients and their family members and non-clinical caregivers?
Implementation Issues
- 7.
What are the issues associated with implementing the optimal use of diagnostic strategies, including imaging, for acute PE in adults in urban, rural, and remote settings?
Environmental Impacts
- 8.
What are the environmental impacts associated with the use of diagnostic pathways, including imaging studies, for the diagnosis of PE in adults in urban, rural, and remote settings?
Questions 1 through 3 will be addressed through a SR of available clinical evidence, and question 4 will be addressed through a primary economic evaluation. The questions related to patient experiences and perspectives (5 to 6) will be addressed through a rapid review of the relevant qualitative literature. Implementation issues (question 7), and environmental factors (question 8) associated with imaging for PE diagnosis will be addressed through informal literature searches and narrative summaries.
