Table 3

Data collection: content of CRF

Part	Data content
Patient data	Patient ID
	Date of birth*
	Gender*
	Weight on the first day of hospitalisation*
	Community pharmacist*†
	Reason for hospitalisation*
	Reason for exclusion
	(Co)morbidity*
	Day of hospitalisation*
	Hospital discharge date*
	Any surgery (coded with Verrichtingen code)12 or diagnosis during hospitalisation*
Study outcomes	Bleeding (major bleeding and non-major bleeding) event(s) during hospitalisation*
	Bleeding (major bleeding and non-major bleeding) event(s) within 3 months after hospitalisation‡
	Severity of bleeding complication
	Location of bleeding complication
	Thrombotic event(s) during hospitalisation*
	Thrombotic event(s) within 3 months after hospitalisation‡
	Severity of thrombotic complication*
	Location of thrombotic complication
	Date of each readmission in the following 3 months after the first hospitalisation*‡
	The reason for readmission‡
	Quality of life (3 months after discharge):† ▸ Age 0–3: no EQ-5D-Y available ▸ Age 4–7: EQ-5D-Yproxy V.1 ▸ Age 8–11: EQ-5D-Y or EQ-5D-Y proxy ▸ V.1 ▸ Age 12–15: EQ-5D-Y or EQ-5D ▸ Age 16 and older: EQ-5D
	Adherence by the patient to the therapy; MARS5 (3 months after discharge)†
	Patient satisfaction of the antithrombotic therapy; VAS satisfaction scale (3 months after discharge)†
	Adherence to the hospital protocol
	Percentage of TTR of vitamin K antagonists during hospitalisation and as an outpatient during 3 months’ follow-up*
	All-cause mortality*§
	Healthcare costs*
Clinical chemistry data	Laboratory values and the date of determination*§ ▸ INR ▸ APTT ▸ PT ▸ dTT ▸ Hb ▸ Anti-Xa ▸ Creatinine ▸ HT ▸ Erythrocytes ▸ Thrombocytes ▸ eGFR ▸ Weight (Available clinical chemistry data are collected from 3 months before inclusion until 3 months after hospitalisation)
Medication data	Medication use during hospitalisation (coded with ATC code)13 *
	Use of antidotes: tranexamic acid, phytomenadione, fibrinogen, prothrombin complex concentrate, activated prothrombin complex concentrate, eptacog alfa (activated) and protamine (coded with ATC code)13 *
	Use of blood products: blood transfusion and other blood products*
	Overview of medication use 3 months before hospitalisation (coded with ATC code)13§
	Overview of medication use 3 months after hospitalisation (coded with ATC code)13§

*Obtained from the medical record of the hospital information system.
†Obtained from the patient by using a questionnaire.
‡Obtained by sending a small questionnaire asking for visits to the general practitioner or hospital because of a bleeding or thrombotic event within 3 months after hospitalisation.
§Obtained from the community pharmacist and the thrombosis service.
Anti-Xa, antifactor Xa; APTT, activated partial thromboplastin time; CRF, case report form; dTT, diluted thrombin time; eGFR, estimated glomerular filtration rate; Hb, haemoglobin; HT, haematocrit; INR, international normalised ratio; MARS, Medication Adherence Rating Scale; PT, prothrombin time; TTR, time in therapeutic range; VAS, visual analogue scale.