2. Antecedentes de la investigación
3.3 Marco teórico referente a la población de estudio
Table A5A: Summary of studies used to generate QALYs gained for each intervention in each patient group Patient groups/interventions QALYsgained Patients Comparator Country Time horizon Source Notes
Treatment of acute MI:
Community resuscitation 0.220 Patients with cardiac arrest of cardiac origin
No
resuscitation Norway Up to 24 years Naess and Steen (2004) Assume HRQOL of 0.6 from study based on lowest value in Ward et al. (2007). 1,066 of 2,831 cardiac arrest patients survived from ROSC until hospital admission for a mean time of 532 days. Assume all would have died without resuscitation. Hospital resuscitation 0.619 Patients with
cardiac arrest of cardiac origin alive at arrival at hospital
No
resuscitation Norway Up to 24 years Naess and Steen (2004) Assume HRQOL of 0.6 from study based on lowest value in Ward et al. (2007). 269 of 1,066 cardiac arrest patients alive at admission survived for a mean time of 6.13 years. Assume all would have died without resuscitation.
Thrombolysis 0.058 Patients with
chest pain with electrocardiographic signs that were typical of myocardial infarction
No thrombolytic therapy
The
Netherlands 1 year Vermeer (1988) et al. Table 3, ‘Quality adjusted data’ for ‘All patients’.
Aspirin 0.213 Cannot find studies
comparing aspirin versus usual care; use same estimates as for Secondary prevention of CHD post-MI (this was also assumed in the IMPACT study). Clopidogrel 0.077 Patients with acute
coronary syndromes Standard therapy UK Lifetime Main (2004)et al. Table 29, p. 43. Primary angioplasty 0.084 Patients with acute
myocardial infarction Thrombolysis UK 6 months Hartwell (2005) et al. Table 18, p. 38. Secondary prevention of CHD post-MI:
Aspirin 0.213 Patients aged 35–84
years with coronary disease and who survived the first month with it
No treatment USA Up to 25
years Gaspoz (2002) et al. Table 2. QALYs gained = 121,768,000 (‘current use of aspirin’) minus 115,535,000 (‘zero utilisation’) in a population of ‘about 6.8 million people’ are estimated to have CHD, and each year about 700,000 to 900,000 new cases are estimated to occur.
Clopidogrel 0.038 Patients with prior occlusive vascular events
Aspirin UK Lifetime Karnon et al.
(2005) Table 4, ‘Baseline’ analysis. Beta blockers 0.142 Patients discharged
following MI, without absolute contraindications for beta blocker use
No treatment USA 20 years Phillips et al.
(2000) Table 3, QALYs gained = 42,000 (‘Current’ minus ‘Zero’ beta blocker use) (Size of single cohort = 296,613, online technical appendix 8) ACE inhibitors 0.180 Survivors of
myocardial infarction with an ejection fraction <=40%
Placebo USA 4 years Tsevat et al.
(1995) Table 4, ‘Limited benefit model’ for patients age 60.
Statins 0.103 Patients who have
had coronary events No statin therapy UK Lifetime Ward (2007)et al. Table 63, p. 101, figures for men aged 85.
Warfarin 0.006 Cannot find studies
investigating warfarin for secondary prevention of CHD; use same estimates as for stroke.
Rehabilitation 0.009 Patients who had had an acute coronary syndrome
Conventional
Revascularisation:
CABG surgery 0.400 Patients appropriate
for CABG only Medical management UK 6 years Griffin (2007)et al. Table 3, ‘Adjusted MD’ values in those ‘Appropriate for CABG’ only.
Angioplasty 0.060 Patients appropriate
for PCI only Medical management UK 6 years Griffin
et al.
(2007) Table 3, ‘Adjusted MD’ values in those ‘Appropriate for PCI’ only.
Treatment of unstable angina:
Aspirin 0.213 Cannot find studies
comparing aspirin versus usual care; use same estimates as for secondary prevention of CHD post-MI (this was also assumed in the IMPACT study). Clopidogrel 0.077 Patients with acute
coronary syndromes Standard therapy UK Lifetime Main (2004)et al. Table 29, p. 43. Glycoprotein IIB/IIIA
antagonists 0.099 Patients with non-ST-elevation acute coronary syndromes
No use
of GPAs UK Lifetime Palmer
et al.
(2005) Table 2. Strategy 1 versus strategy 4. Treatment of chronic stable angina:
Aspirin 0.213 Patients aged 35–84
years with coronary disease and who survived the first month with it
No treatment USA Up to
25 years Gaspoz (2002) et al. Table 2. QALYs gained = 121,768,000 (‘current use of aspirin’) minus 115,535,000 (‘zero utilisation’) in a population of ‘about 6.8 million people’ are estimated to have CHD, and each year about 700,000 to 900,000 new cases are estimated to occur.
Clopidogrel 0.038 Patients with prior occlusive vascular events
Aspirin UK Lifetime Karnon et al.
(2005) Table 4, ‘Baseline’ analysis.
Statins 0.103 Patients with CHD No statin
therapy UK Lifetime Ward (2007)et al. Table 63, p.101, figures for men aged 85 Treatment of arrhythmia:
ICD 1.060 Patients with
arrhythmia Amiodarone treatment UK 20 years Buxton (2006) et al. Table 85, p.106, ‘UK average patient’ Treatment of heart failure:
ACE inhibitors 0.110 Persons with symptomatic heart failure and left ventricular ejection fractions <=35% Placebo Belgium, Canada and the USA 4 years Glick et al.
(1995) Table 1, Within-trial model, Total.
Beta blockers 0.137 Patients with chronic
heart failure Placebo UK 5 years Varney (2001) Assume HRQOL of 0.6 from study based on lowest value in Ward et al. (2007). This is multiplied by LYG under the ‘Limited benefits’ scenario (0.228 years; p. 368 section 3.1). Note that this assumes no morbidity benefit.
Diuretics 0.130 Patients with severe
heart failure and a left ventricular ejection fraction of <=35% Standard therapy + placebo 16 countries 35
months Glick (2002)et al. Table 1, Total.
Aspirin 0.213 Cannot find studies
comparing aspirin versus usual care; use same estimates as for secondary prevention of CHD post-MI (this was also assumed in the IMPACT study).
Statins 0.103 Cannot find studies for
statins in this patient group; use same estimates as for secondary prevention of CHD post-MI (this was also assumed in the IMPACT study).
CRT-P 0.700 Patients with heart
failure with a marker for cardiac dyssynchrony and left ventricular systolic dysfunction Optimal pharmaceutical therapy UK Lifetime Fox et al. (2007) Table 58, p. 67, ‘Mixed’
CRT-D 0.990 Patients with heart
failure with a marker for cardiac dyssynchrony and left ventricular systolic dysfunction Optimal pharmaceutical therapy UK Lifetime Fox et al. (2007) Table 64, p. 83, ‘Mixed’.
Heart transplant:
Heart transplant 1.475 Patients with end-
stage heart failure Death UK 5 years Clegg (2005)et al. Cannot find specific figures for heart transplant; see Table 52, p. 104 and use figures for Medical group, assuming 7.2 months pre- transplant life expectancy for no transplant. Treatment of acute stroke:
Aspirin 0.013 Cannot find studies
comparing aspirin versus usual care; use same estimates as for secondary prevention of stroke. Anticoagulants 0.090 Patients aged 18 years
and above with acute stroke
Placebo USA and
Canada Lifetime Samsa (2002) et al. Table 3, ‘Trial+long term’.
tr-PA 0.036 Patients with acute
ischaemic stroke Standard care UK Lifetime Sandercock et al. (2002) Table 10, p. 76, ‘Base case’. Stroke unit 0.190 Patients with acute
stroke Contemporary conventional care
UK 5 years Chambers
et al. (1998) Early diagnosis and treatment 0.078 Patients with
acute stroke (but not subarachnoid haemorrhage)
Do not scan
anyone UK 5 years Wardlaw et al. (2004) Table 3, Comparator minus S12.
Secondary prevention of stroke:
Rehabilitation therapy 0.009 Cannot find studies for
rehabilitation in this patient group; use same estimates as for Secondary prevention of CHD post-MI
Aspirin 0.013 Patients aged 70 who
had survived an initial stroke and who were suitable for treatment with an antiplatelet therapy
No treatment
strategy UK 5 years Beard (2004)et al.
Clopidogrel 0.038 Patients with prior occlusive vascular events
Aspirin UK Lifetime Karnon et al.
(2005) Table 4, ‘Baseline’ analysis.
Statins 0.103 Cannot find studies for
statins in this patient group; use same estimates as for secondary prevention of CHD post-MI.
Warfarin 0.006 40–80 year old men
and women after their first idiopathic venous thromboembolic event or pulmonary embolism 3 month conventional therapy with warfarin (standard therapy after stroke)
USA Lifetime Aujesky et al.
(2005) Figures for men aged 40 years, 6 months conventional therapy versus 3 month conventional therapy (standard therapy after stroke).
Antihypertensive drugs 0.142 Cannot find studies in this
patient group; use same estimates as for beta blockers for secondary prevention of CHD post-MI. Primary prevention of CVD:
Treatment of hypertension 0.060 65 year old women with an annual CVD risk of 2%, HF risk of 1% and diabetes risk of 1.1%
Thiazide-type
diuretics UK Lifetime National Collaborating Centre for Chronic Conditions (2006)
Table 3, p. 13, figures for women, C versus D.
Treatment of
hypercholesterolaemia 0.310 Patients aged 55 years without CHD No treatment UK 20 years Davies (2007)et al. Figures for women receiving PRA (least effective). Primary prevention of stroke:
Warfarin 0.810 70 yr old patients with AF at moderate risk of stroke
Aspirin USA 20 years O'Brien et al.
(2005) Table 2, base case.
Aspirin 0.020 Patients aged 50–60
years with no known CVD
No treatment UK 10 years Annemans
et al. (2006) Table 5, risk level = 5%. Smoking cessation:
Quitting smoking 0.990 55–64 year old Not quitting
smoking UK Lifetime Wang (2008)et al. Table 14, p. 38, use 0.99 value (most conservative). CHD = coronary heart disease, MI = myocardial infarction, ICD = implantable cardioverter defibrillator, CRT-P = cardiac resynchronisation therapy device, CRT-D = CRT device plus ICD, CVD = cardiovascular disease.