a. Efficacy: Cerebrovascular events (ipsilateral or any vascular territory stroke, Ischemic or hemorrhagic stroke, stroke of any severity (e.g., minor or major), death (all-cause death, cerebrovascular death, composite cardiovascular outcomes, myocardial infarction, other cardiovascular events (stroke plus transient ischemic attack (TIA), including amaurosis fugax) or TIA based on either the tissue definition or the time definition<br>b. Safety: Complications and adverse events within 30 days after procedure, cerebrovascular events (ipsilateral or any vascular territory stroke, Ischemic or hemorrhagic stroke periprocedural myocardinal infarction, death (all-cause death, cerebrovascular death, composite cardiovascular outcomes, periprocedural composite outcomes, cranial nerve palsy, bleeding complications at the surgical or the vascular access site (p. 8)
Mortality, general health, health related quality of life, adverse events (p. iii), system-related events (p. 41)
a. Efficacy: Revascularisation of an already treated lesion following the reappearance of clinical symptoms, restenosis (p. 4)<br>b. Safety: primary – death, thrombosis, secondary – myocardial infarction, major adverse cardiac events (death, myocardial infarction, stroke) (p.4)
Death, recurrent myocardinal infarction, target vessel revascularization, target lesion revascularization, stent thrombosis) (p.11)
successful revascularisation, occurrence of restenosis, avoidance of major adverse cardiac events, including death, myocardial infarction and stroke, restenosis (measuring late lumen loss, presence of coronary stenosis greater than 50% = binary restenosis) (p. 6)
Outcomes for endovascular interventions: Procedural outcomes and complications, long-term outcomes (at least 12 month) including clinical anatomic and hemodynamic outcomes (p. 20)<br>a. Efficacy: Long-term (>6 month) clinical outcomes: mortality, amputation, reintervention of treated vessel or lesion, clinical symptoms, quality of life, ulcer healing, ankle-brachial index, standardized walking time tests, improvement and maintenance of clinical status<br>b. Safety: Stent fracture, graft patency (surrogate), recurrence of primary symptoms, loss of pulse (p. 19ff)- patients with claudication: QoL questionnaires, treadmill testing (p. 20)<br>- Patients with critical limb ischemia: complete wound healing, amputation-free survival (primary outcome), resolution of pain, limb salvage (p. 20)<br>- Peripheral stenting compared to other interventions: death, amputation, quality of life, surrogates: asymptomatic restenosis found with ultrasonography (p. 20ff)
successful revascularisation, occurrence of restenosis, avoidance of major adverse cardiac events, including death, myocardial infarction and stroke, restenosis (measuring late lumen loss, presence of coronary stenosis greater than 50% = binary restenosis) (p. 6)
Effectiveness, safety and economic issues (p. 1)
Mortality, morbidity, quality of life (p. 7; 2008)
a. Efficacy: prolongation of life, quality of life<br>b. Safety: 1-month-, 6-months-, 12-months-mortality, morbidity, intervention-related and non-intervention related adverse events (p. 11)
Technical success rate, complications, follow-up data, surgical aortic valve replacement after(attempted) percutaneous approach (p.23ff)
no a-priori outcomes defined
Overall survival, cardiac or coronary mortality (fatal myocardial infarction, sudden cardiac death, other cardiac deaths), cardiac or coronary morbidity, non-fatal myocardial infarction, acute coronary syndrome, coronary revascularisation due to symptomatic coronary heart disease (CHD), arrhythmia requiring treatment, occurrence or worsening of heart failure, other vascular events (especially refractory coronary ischemia), hospitalisation (overall, for cardiac reasons), side effects and complications of the treatment, health-related quality of life, dependence on outside assistance or care dependency, physical capacity, management of everyday activities, diameter of the lumen of the stented vessel (p. 7ff)
Diagnostic accuracy outcomes used to measure venous reflux and determine the position of reflux e.g. sensitivity, specificity, likelihood ratios; Clinical consequences of diagnostic test i.e. how the test affects the treatment plan or influences unnecessary treatment (p. 7)
Diagnostic accuracy outcomes used to measure venous reflux and determine the position of reflux e.g. sensitivity, specificity, likelihood ratios; Clinical consequences of diagnostic test i.e. how the test affects the treatment plan or influences unnecessary treatment (p. 7)
Diagnostic accuracy outcomes used to measure venous reflux and determine the position of reflux e.g. sensitivity, specificity, likelihood ratios; Clinical consequences of diagnostic test i.e. how the test affects the treatment plan or influences unnecessary treatment (p. 7)
no a-priori outcomes defined
no a-priori outcomes defined
no a-priori outcomes defined
a. Efficacy: Comparison to an acceptable reference standard, further diagnostic testing, clinical – mortality cardiac symptoms or function, functional status; process – therapeutic interventions (p. 47ff)