CRITICAL APPRAISAL EBM PROGNOSIS II

KELOMPOK A13GASTROINTESTINAL SYSTEM2012CRITICAL APPRAISALEBM PROGNOSIS IIN Beckett, R Peters, J Tuomilehto, C Swift, P Sever, J Potter, T McCormack, F Forette, B Gill-Extremera, D Dumitrascu, J A Staessen, L Thijs, A Fletcher, C Bulpitt for the HYVET group.BMJ Research January 4, 2012.Immediate and Late Benefits of Treating Very Elderly People with Hypertension : Results from Active Treatment Extension to Hypertension in the Very Elderly Randomised Controlled TrialABSTRACTObjectiveTo assess if very elderly people with hypertension obtain early benefit from antihypertensive treatment.DesignOne year open label active treatment extension of randomized controlled trial (Hypertension in the Very Elderly Trial [HYVET])SettingHospital and general practice based centers mainly in eastern and western Europe, China and Tunisia.ParticipantsPeople on double blind treatment at the end of HYVET were eligible to enter the extension.InterventionParticipants on active blood pressure lowering treatment continued taking active drug; those on placebo were given active blood pressure lowering treatment. The treatment regimen was as used in the main trial indapamide SR 1,5mg (plus perindopril 2-4mg if required) with the same target blood pressure of less than 150/80mmHg.ABSTRACTMain Outcome MeasuresThe primary outcome was all stroke; other outcomes included total mortality, cardiovascular mortality and cardiovascular events.ResultsOf 1882 people eligible for entry to the extension, 1712 (91%) agreed to participate. During the extension period , 1682 patients years was accrued. By six months, the difference in blood pressure between the two groups was 1.2/0.7mmHg. Comparing people previously treated with active drug and those previously on placebo, no significant differences were seen for stroke (n=13; hazard ratio 1.92; 95%CO ,0.59 to 6.22) or cardiovascular events (n=25, 0.78, 0.36 to 1.72). Differences were seen for total mortality (47 deaths; hazard ratio 0.48, 0.26 to 0.87, P=0.02) and cardiovascular mortality (11 deaths; 0.19, 0.04 to 0.87; P=0.03) ConclusionsVery elderly patients with hypertension may gain immediate benefit from treatment. Sustained differences in reductions of total mortality and cardiovascular mortality reinforce the benefits and support the need from early and long term treatment.Validity Importance - ApplicabilityEBM PROGNOSIS WORKSHEETAre the results of the study valid?EBM Prognosis Worksheet - ValidityWas the defined representative sample of patients assembled at a common (usually early) point in the course of their disease?

Yes.Was patient follow-up sufficiently long and complete?The follow-up was not long enough, but complete.Were outcome criteria either objective or applied in a blind fashion ?Yes.If subgroups with different prognoses are identified, did adjustment for important prognostic factors take place? Yes.Was there validation in an independent group ("test set") of patients?Yes.Are the valid results of this randomized trial important ?EBM Prognosis Worksheet - ImportanceHow likely are the outcomes over time ?The outcomes will be better.How precise is the prognostic estimated ?Very precise.CalculationN =924 P = 17/924 = 0.018 = 1.8% SE = 0.46% 95% CI = 1,076% to 2,644% CAN YOU APPLY THIS VALID, IMPORTANT EVIDENCE ABOUT PROGNOSIS IN CARING FOR YOUR PATIENT ?EBM PROGNOSIS WORKSHEET - APPLICABILITYIs our patient so different from those in the study that its results cannot apply ?No.Will this evidence make a clinically important impact on my conclusions about what to offer to tell my patients ?Yes.Thank you!