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Evaluating non-randomised intervention studies - NIHR Health ...

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<strong>Health</strong> Technology Assessment 2003; Vol. 7: No. 27TABLE 40 Distribution of baseline characteristics in 10 UK cities combining results across 28 hospitals (IST)Sample sizeAdverse outcome (%)Delay (h) (mean)Female (%)Age (years) (mean)Systolic blood pressure (mean)Symptoms on waking (%)Drowsy or unconscious (%)Atrial fibrillation (%)Deficit score (mean)No CT scan (%)Partial anterior +total anterior strokes (%)Belfast 234 85 26 47 76 151 30 38 22 3.1 28 40 + 29 = 70Bishop Auckland 234 80 16 48 74 159 30 31 19 3.2 75 41 + 31 = 72Blackburn 221 83 15 52 72 161 30 21 18 3.2 74 45 + 24 = 69Edinburgh 329 57 22 49 69 159 29 20 20 3.0 34 36 + 27 = 63Leeds 226 58 19 54 65 160 28 19 10 2.9 64 34 + 24 = 58Liverpool 536 80 17 54 72 162 26 19 19 2.8 89 49 + 21 = 71London 344 82 24 49 76 160 27 26 23 3.2 12 39 + 27 = 66Newcastle 361 83 26 46 75 156 26 31 21 3.3 25 39 + 32 = 71Nottingham 305 83 17 50 77 161 22 24 22 3.2 97 31 + 30 = 61Sheffield 308 71 21 58 71 159 27 21 14 3.0 50 38 + 23 = 61The distribution of the outcome of dead ordependent at 6 months and of the baselinecharacteristics in these sub-<strong>studies</strong> are described inTable 38. Table 39 describes the baselinecharacteristics for the cohorts split according to‘early recruits’ (before) and ‘late recruits’ (after).Differences are evident in both tables in thefrequency of the outcome and for some of thebaseline characteristics, notably the percentagewith total anterior strokes, or admitted ‘drowsy orunconscious’.These 14 regions contain data from 15,502 (80%)of the <strong>randomised</strong> participants. The 3933excluded participants were recruited in Argentina,Austria, Belgium, Brazil, Canada, Chile, CzechRepublic, Denmark, Eire, Finland, France, Greece,Hong Kong, Hungary, India, Israel, Japan,Portugal, Romania, Singapore, Slovak Republic,Slovenia, South Africa, Sri Lanka, Turkey and theUSA, but without sufficient numbers in any regionto construct an additional centre.A second set of 10 sub-<strong>studies</strong> was constructedfrom the UK data, by grouping hospitals withincities, including a total of 3098 participants (50%of those recruited in the UK). The distribution ofbaseline variables across the 10 cities is shown inTable 40. Data from these sub-<strong>studies</strong> were usedonly to construct concurrently controlled <strong>studies</strong>,insufficient data being available for the historicallycontrolled comparisons.The European Carotid SurgeryTrial (ECST) 133Description of the trialThe ECST investigated the risks and benefits ofcarotid endarterectomy, primarily in terms ofstroke prevention. Between October 1981 andMarch 1994, 3024 patients with recentlysymptomatic carotid stenosis entering 100centres in 14 countries were <strong>randomised</strong> tocarotid endarterectomy or control (avoid surgeryas long as possible). Patients were eligible forinclusion if they had had at least one transient ormild symptomatic ischaemic vascular event withinthe last 6 months, and had some degree ofcarotid stenosis. Randomisation was performedcentrally using a minimisation algorithm, 60% ofpatients being allocated to surgery and 40% tocontrol.Of the 1811 allocated surgery, 1745 (96%) hadreceived it within 1 year. Of the 1213 allocatedcontrol, 42 (3%) received surgery within 1 year.The control treatment usually consisted of advice171© Queen’s Printer and Controller of HMSO 2003. All rights reserved.

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