Patients in emergency settings who require haemodynamic monitoring: change in clinical outcomes (length of hospital stay; morbidity and mortality; time to correct diagnosis, readmission rate), change in clinical management (Changes to treatment (such as admission for further hospital care; further haemodynamic monitoring; change of medication)), technical accuracy (correlation; reproducibility), safety outcomes (adverse events known to be associated with non-invasive continuous wave Doppler ultrasound are patient discomfort/tolerance to the procedure, adverse events (death, pulmonary artery rupture, bleeding, pneumothorax, infection, stroke, arrhythmias, respiratory obstruction and jugular vein thrombosis) (p. 8ff)
Technical accuracy, diagnostic value (p. 13), patient related outcomes (thrombo-embolic events, major bleeding episodes, and death from all causes) (p. 30), needs and preferences of patients, fears, satisfaction, training, education, obstacles, compliance (p.51)
no a-priori outcomes defined
a. Safety: Primary – Adverse events: Physical, psychological due to testing (anxiety to a false positive diagnosis), delay from false negative diagnosis Secondary – Exposure to radiation (p. 35)<br>b. Efficacy: Diagnostic accuracy (sensitivity and specificity (rates of false positives and negatives), likelihood ratios and diagnostic odds ratios, positive and negative predictive values, diagnostic yield) (p. 49), change in management (treatment rates, method of treatment, time to diagnosis, rate of referral to specialist, rates of diagnostic tests,change in health outcomes: Primary – rate of survival/death, symptom resolution, quality of life, functional status, acute myocardial infarction, Secondary – Hospital length of stay, discharge diagnosis, rate of readmission (p. 97)
- Patient-relevant endpoints: Mortality (overall mortality and cardiovascular mortality), morbidity (survival without cardiovascular events (cardiac death, myocardial infarction, unintended revascularisation)), undesirable events, severity of symptoms (ef
- Patient-relevant endpoints: Mortality (overall mortality and cardiovascular mortality), morbidity (survival without cardiovascular events (cardiac death, myocardial infarction, unintended revascularisation)), undesirable events, severity of symptoms (ef
Diagnostic accuracy in imaging regarding the stent location/position, stent-thrombi and histomorphological composition of plaque (p. 7)
Diagnostic accuracy (absolute numbers of true positives, false positives, false negatives and true negatives, or sensitivity and specificity for CT angiography), likelihood of future cardiac events, pattern of coronary artery disease (CAD) and suitability for revascularisation, accuracy of 64-slice or higher CT angiography for detecting stenosis in stents or grafts (p.11)
no a-priori outcomes defined
Clinical efficacy, diagnostic accuracy and prognostic value, mortality, morbidity (p. 30 + p. 4 summary)
Diagnostic accuracy (sensitivity, specificity), patient outcomes, potential negative impact of increased radiation exposure, contacts reaction (p. 31ff), treatment and testing decisions, major cardiovascular events (p. 45)
no a-priori outcomes defined
Patient related issues (symptom control, prevention of myocardial infarction, prolongation of life) radiation dose, incorporating death, myocardial infarction, readmissions and late office visits (p.iv)
- Patient-relevant endpoints: Determination of tumor stage (staging), treatment response of the lymphoma (“residual disease evaluation”/ “restaging”), detection of relapses and their effect on mortality and morbidity, diagnostic and prognostic accuracy (p
- Patient-relevant endpoints: Determination of tumor stage (staging), treatment response of the lymphoma (“residual disease evaluation”/ “restaging”), detection of relapses and their effect on mortality and morbidity, diagnostic and prognostic accuracy (p
a. Efficacy: Pain, disability, quality of life, patient satisfaction, ability to work (p. 9)<br>b. Safety: Complications (reoperations, product failure or removement, neurological complications, infections, adjacent segment degeneration, death) (p. 9)
Pain reduction (according to VAS), functionality (e.g. measured by Oswestry-Index or Rland-Morris Scale), quality of life, adjacent fractures, other complications (p. 7)