Table 1 List of data items required
Type of data | |
|---|---|
Study level | Country in which study was carried out |
Number of participants randomized | |
Number allocated to the BNP group | |
Number allocated to the standard care group | |
Setting (primary care, hospitals, specialist clinics) | |
Date first patient randomized | |
Date final patient randomized | |
Date of final follow-up | |
Did the study measure quality of life (state tool that was used) | |
Did the study measure heart failure risk score (state tool that was used) | |
Details of intervention (frequency of testing, actions, etc.) | |
Details of comparator (frequency of review, actions, etc.) | |
Individual participant | Variables collected at study entry |
Demography | Age |
Sex | |
Body mass index (or weight and height) | |
Smoking status | |
Date of entry into study/date of randomization | |
Allocated to BNP or standard care | |
Centre if multi centre | |
Medical history | Cause of heart failure |
Previous myocardial infarction | |
Previous intervention (PCI/CABG) | |
Previous stroke | |
Previous angina pectoris | |
Previous peripheral artery disease | |
Diabetes status (including type) | |
History of hypertension | |
History of atrial fibrillation | |
History of chronic obstructive pulmonary disease | |
Pacemaker in situ | |
Implantable cardioverter defibrillator in situ | |
Heart failure risk score (if measured) | |
Individual participant | Variables collected at each visit (data required for all visits including baseline visit) |
Date of visit | |
Clinical | NYHA class |
Left ventricular ejection fraction | |
Resting heart rate | |
Systolic blood pressure | |
Diastolic blood pressure | |
Heart failure score | |
Laboratory | BNP/NT-BNP |
Creatinine | |
Sodium | |
Potassium | |
Blood urea nitrogen | |
Haemoglobin | |
Drug treatment | ACE inhibitors |
Angiotensin receptor blockers | |
Beta-blockers | |
Mineralocorticoid receptor antagonists | |
Loop diuretic | |
Thiazide diuretics | |
Vasodilator | |
Other potassium sparing diuretic | |
Aspirin | |
Other anti-platelet agent | |
Oral anticoagulant | |
Digoxin | |
Amiodarone | |
Other anti-arrhythmic | |
Calcium-channel blocker | |
Statin | |
Quality of life | If collected (derived scores if available) |
Individual participant | Clinical outcomes (data required for all deaths, hospital admissions or cardiovascular events) |
Date of death | |
Cause of death | |
Date of hospital admission/cardiovascular event | |
Date of hospital discharge | |
Details of reason for admission/cardiovascular event (for example heart failure, non fatal myocardial infarction, non-fatal stroke, new atrial fibrillation, fitting of pacemaker/CRT device/implantable cardioverter defibrillator) | |
Lost to follow-up? | Date of last follow-up |