Table 1.
Study procedure | Baseline | Day of surgery | Index hospital stay | Follow-up: time is calculated from the day of index surgery | |||||
−26 weeks to day of surgery | Day 0 | Day 0 until discharge following index surgery | 6 weeks | 12 weeks | 18 weeks | 24 weeks | 38 weeks | 52 weks | |
Consent | X | ||||||||
Medical history | X | ||||||||
Physical examination | X | ||||||||
Demographics | X | ||||||||
Concomitant medications | X | X | X | X | |||||
Pregnancy test | X | ||||||||
NYHA class | X | X | X | ||||||
ECHO (TTE) | X | X | X | X | X | ||||
TOE | X | X | |||||||
SF-36v2 | X | X | X | X | X | X | X | ||
EQ-5D-5L | X | X | X | X | X | X | X | ||
euroSCORE | X | ||||||||
Accelerometer | X | X | X | X | X | X | X | ||
Eligibility check | X | ||||||||
Randomisation | X | ||||||||
MVr surgery | X | ||||||||
Postoperative details | X | ||||||||
Wound Pain score | Xi | X | X | ||||||
Ward usage and date of discharge | X | ||||||||
Discharge destination | X | ||||||||
RBC and other blood product transfusions | X | X | |||||||
AEs and SAEs | X | X | X | X | X | X | X | X | |
Reoperation/further surgery | X | X | X | X | X | X | X | X | |
Health Care Utilisation Questionnaire | X | X | X | X | X | X | |||
HES data | X | X | X | X | X | X | |||
NICOR data | X | X | X | X | X | X | |||
Medical record review | X | X | X | X | X | X |
AE, adverse event; ECHO, Echocardiogram; EQ-5D-5L, EuroQol 5 Dimension 5 Level; HES, Hospital Episode Statistics; MVr, mitral valve repair; NICOR, National Institute for Cardiac Outcomes Research; NYHA, New York Heart Association; RBC, Red Blood Celleuor; SAE, serious adverse event; SCORE, European System for Cardiac Operative Risk Evaluation; SF36-v2, Short Form Health Survey; TOE, transoesophageal echocardiography; TTE, transthoracic echocardiography.