Table 3

The outcomes reporting for clinical trials of anticoagulant treatment (N=130)

Domains/outcomesOutcomes reporting (n)OMIs/definitions (n)Measurement time point (n)
Mortality/survival
 All-cause mortality52240
 Cardiovascular death26213
 Death from ischaemic events301
 Death from stroke111
 Death from bleeding101
 Non-cardiovascular death101
Vascular outcomes
 Non-central nervous system embolism73131
 Major bleeding751042
 Time to first major bleeding event203
 Minor bleeding2128
 Clinically relevant non-major bleeding1545
 Time to first clinically relevant non-major bleeding event102
 Time to the first SEE201
Cardiac outcomes
 Acute coronary syndrome31027
 Ultrasonic cardiogram111
 Blood pressure101
 Heart failure101
 NT-proBNP213
Blood and lymphatic system outcomes
 INR1717
 Prothrombin time815
 APTT815
 PT1026
 TT515
 FIB413
 Thrombin time514
 Time spent in the therapeutic range503
 PLT202
 RBC101
 HGB101
 D-dimer303
 Haemorheology111
 Thromboela-stogram111
 Plasma P selectin111
 TXB2111
Nervous system outcomes
 Ischaemic stroke105256
 Haemorrhagic stroke75239
 Transient ischaemic attack18010
 Intracranial bleeding14211
 Time to the first stroke302
 Score standard of neural function deficient degree111
 Dementia101
Hepatobiliary outcomes
 ALT202
 AST202
 TBIL101
Renal and urinary outcomes
 Serum creatinine111
 Glomerular filtration rate101
 BUN111
 Creatinine clearance101
 Carbamide101
 β2-microglobulin111
Musculoskeletal and connective tissue outcomes
 Hip fracture201
 Pelvic fracture101
 Vertebral fracture101
General outcomes
 Symptoms303
 Warfarin dosage201
 INR variance growth rate111
 Time to stable anticoagulation101
 Weight101
 Traditional Chinese medicine syndrome212
 CRP101
 CGA score112
Physical functioning
 Modified Rankin Scale score111
 Disability101
Satisfaction/patient preference
 Patient satisfaction334
Adherence/compliance
 Therapeutic compliance1109
 Anticoagulation discontinuation318
Withdrawal from treatment
 Withdrawal from treatment112
Global quality of life
 Quality of life454
Economic
 Index hospitalisation costs111
Resource use: Hospital
 Admission for cerebrovascular event735
 All-cause hospitalisation402
 Cardiovascular hospitalisation401
 Hospital length of stay311
 Bleeding-cause hospitalisation203
 Healthcare resource utilisation211
 Emergency room visits1010
 Readmission rates2111
Need for further intervention
 The difference between the predicted and the actual warfarin maintenance dose101
 The number of warfarin dose changes needed101
 First catheter ablation101
 First AV node/His bundle ablation101
Adverse events/effects
 Adverse events/effects1607
  • ALT, alanine aminotransferase; APTT, activated partial thromboplastin time; AST, aspartate aminotransferase; AV, atrioventricular; BUN, blood urea nitrogen; CGA, comprehensive geriatric assessment; CRP, C reactive protein; FIB, fibrinogen; HGB, haemoglobin; INR, international normalised ratio; NT-proBNP, N terminal pro B type natriuretic peptide; PLT, platelet; PT, prothrombin time; RBC, red blood cell; SEE, systemic embolic event; TBIL, total bilirubin; TT, thrombin time; TXB2, thromboxane B2.