title: A new method of applying randomised control study data to the individual patient: A novel quantitative patient-centred approach to interpreting composite end points.
abstract: BACKGROUND
  Modern randomised controlled trials typically use composite endpoints. This is only valid if each endpoint is equally important to patients but few trials document patient preference and seek the relative importance of components of combined endpoints. If patients weigh endpoints differentially, our interpretation of trial data needs to be refined.
  
  
  RESULTS
  We derive a quantitative, structured tool to determine the relative importance of each endpoint to patients. We then apply this tool to data comparing angioplasty with drug-eluting stents to bypass surgery. The survey was administered to patients undergoing cardiac catheterisation. A meta-analysis comparing coronary artery bypass grafting (CABG) to percutaneous coronary interventuin (PCI) was then performed using (a) standard MACE and (b) patient-centred MACE. Patients considered stroke worse than death (stroke 102.3 ± 19.6%, p < 0.01), and MI and repeat revascularisation less severe than death (61.9 ± 26.8% and 41.9 ± 25.4% respectively p < 0.01 for both). 7 RCTs (5251 patients) were eligible. Meta-analysis demonstrated that standard MACE occurs more frequently with PCI than surgery (OR 1.44; 95% CI 1.10 to 1.87; p = 0.007). Re-analysis using patient-centred MACE found no significant difference between PCI and CABG (OR 1.22, 95% CI 0.97 to 1.53; p = 0.10).
  
  
  CONCLUSIONS
  Patients do not consider the constituent endpoints of MACE equal. We derive a novel patient-centred metric that recognises and quantifies the differences attributed to each endpoint. When patient preference data are applied to contemporary trial results, there is no significant difference between PCI and CABG. Responses from individual patients in clinic could be used to give individual patients a recommendation that is truly personalised.
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK.
authors.forename: Yousif
authors.initials: Y
authors.lastname: Ahmad
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK.
authors.forename: Sukhjinder
authors.initials: S
authors.lastname: Nijjer
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK.
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Cook
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK.
authors.forename: Majd
authors.initials: M
authors.lastname: El-Harasis
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK.
authors.forename: John
authors.initials: J
authors.lastname: Graby
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Petraco
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK.
authors.forename: Tushar
authors.initials: T
authors.lastname: Kotecha
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK.
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Baker
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK.
authors.forename: Iqbal S
authors.initials: IS
authors.lastname: Malik
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK.
authors.forename: Michael F
authors.initials: MF
authors.lastname: Bellamy
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK.
authors.forename: Amarjit
authors.initials: A
authors.lastname: Sethi
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK.
authors.forename: Ghada W
authors.initials: GW
authors.lastname: Mikhail
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK.
authors.forename: Mahmud
authors.initials: M
authors.lastname: Al-Bustami
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK.
authors.forename: Masood
authors.initials: M
authors.lastname: Khan
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK.
authors.forename: Raffi
authors.initials: R
authors.lastname: Kaprielian
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK.
authors.forename: Rodney A
authors.initials: RA
authors.lastname: Foale
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK.
authors.forename: Jamil
authors.initials: J
authors.lastname: Mayet
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK.
authors.forename: Justin E
authors.initials: JE
authors.lastname: Davies
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK.
authors.forename: Darrel P
authors.initials: DP
authors.lastname: Francis
authors.affiliation: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London W2 1LA, UK. Electronic address: sayan.sen@imperial.ac.uk.
authors.forename: Sayan
authors.initials: S
authors.lastname: Sen
mesh_terms: D001026:Coronary Artery Bypass / Q000009:adverse effects / Q000379:methods; D003324:Coronary Artery Disease / Q000601:surgery*; D054855:Drug-Eluting Stents; D023381:Endpoint Determination / Q000379:methods*; D006801:Humans; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D063868:Patient Outcome Assessment; D018579:Patient Selection; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D011183:Postoperative Complications / Q000517:prevention & control*; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D012086:Reoperation / Q000706:statistics & numerical data; D020521:Stroke / Q000209:etiology / Q000517:prevention & control
keywords: Angioplasty; CABG; Drug eluting stents; MACE; Meta-analysis; Randomised control trials