Outcomes The following outcomes are relevant to test the clinical claim that MRI has superior diagnostic performance compared to other tests and will improve clinical management decisions regarding patients with extra-hepatic cancer and suspected liver lesions Effectiveness Change in management Health outcomes Change in clinical diagnosis Liver disease-specific mortality rate Change in treatment pathway (initiated, ceased, modified, avoided) Survival rate Time to initial diagnosis Safety Time from diagnosis to treatment Adverse reaction to contrast agent Quality of life scores Cumulative effects of multiple contrast agent Patient compliance with imaging injections Patient preference for imaging Claustrophobia requiring the administration of Diagnostic accuracy sedation or general anaesthetic Sensitivity, specificity (confirmed by reference Physical harms from follow-up testing standard) Other adverse events arising from liver MRI Positive likelihood ratio, negative likelihood ratio (confirmed by reference standard) Cost effectiveness outcomes ROC curves Unsatisfactory or uninterpretable test results Summary of PICO for population 1 Table 3 Summary of extended PICO to define research question that assessment will investigate Patients Intervention Comparator Reference Tests Outcomes Patients with known Magnetic resonance Liver biopsy Core biopsy As above extrahepatic malignancy imaging with suspected or Multiphase CT Scan Surgical specimen possible liver metastases who are Intraoperative US Clinical or radiological being considered by a follow-up specialist for hepatic therapies (including but not limited to percutaneous ablation, resection or transplantation)
Outcomes The following outcomes are relevant to test the clinical claim that MRI has superior diagnostic performance compared to other tests and will improve clinical management decisions regarding patients with extra-hepatic cancer and suspected liver lesions Effectiveness Health outcomes Liver disease-specific mortality rate Survival rate Time to initial diagnosis Time from diagnosis to treatment Quality of life scores Patient compliance with imaging Patient preference for imaging Diagnostic accuracy Sensitivity, specificity (confirmed by reference standard) Positive likelihood ratio, negative likelihood ratio (confirmed by reference standard) ROC curves Unsatisfactory or uninterpretable test results Change in management Change in clinical diagnosis Change in treatment pathway (initiated, ceased, modified, avoided) Safety Adverse reaction to contrast agent Cumulative effects of multiple contrast agent injections Claustrophobia requiring the administration of sedation or general anaesthetic Physical harms from follow-up testing Other adverse events arising from liver MRI Cost effectiveness outcomes Summary of PICO for population 1 Table 3 Summary of extended PICO to define research question that assessment will investigate Patients Intervention Comparator Reference Tests Outcomes Patients with known extrahepatic malignancy with suspected or possible liver metastases who are being considered by a specialist for hepatic therapies (including but not limited to percutaneous ablation, resection or transplantation) Magnetic resonance imaging Liver biopsy Multiphase CT Scan Intraoperative US Core biopsy Surgical specimen Clinical or radiological follow-up As above
1372-MRILiver-RatifiedFinalProtocol.DOCX