Advertisement

Goldilocks and the three post-cardiac arrest subjects

      Clinical trials conducted in the intensive care setting are often neutral [
      • Harhay M.O.
      • Wagner
      • Ratcliffe S.J.
      • Bronheim R.S.
      • Gopal A.
      • Green S.
      • et al.
      Outcomes and statistical power in adult critical care randomized trials.
      ]. To some extent, this may be explained by issues of statistical power, recruitment, and outcome selection common to all clinical trials. However, the role of heterogeneity of disease severity or unmeasured patient factors may play a larger role [
      • Vincent J.L.
      We should abandon randomized controlled trials in the intensive care unit.
      ]. In conventional trial designs, population-average treatment effects are compared between arms. If a particular therapy helps a third of subjects, hurts a third of subjects and is inert in the remaining third, it will appear to have no benefit compared to placebo.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Resuscitation
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Harhay M.O.
        • Wagner
        • Ratcliffe S.J.
        • Bronheim R.S.
        • Gopal A.
        • Green S.
        • et al.
        Outcomes and statistical power in adult critical care randomized trials.
        Am J Respir Crit Care Med. 2014; 189: 1469-1478
        • Vincent J.L.
        We should abandon randomized controlled trials in the intensive care unit.
        Crit Care Med. 2010; 38: S534-8
        • Callaway C.W.
        Targeted temperature management after cardiac arrest: finding the right dose for critical care interventions.
        JAMA. 2017; 318: 334-336
        • Reynolds J.C.
        • Callaway C.W.
        All [post-cardiac arrest patients] are [not] created equal: editorial on Impact of time to return of spontaneous circulation on neuroprotective effect of targeted temperature management at 33 or 36 degrees in comatose survivors of out-of-hospital cardiac arrest by Kjaergaard et al.
        Resuscitation. 2015; 96: A1-A2
        • Nakatani Y.
        • Nakayama T.
        • Nishiyama K.
        • Takahashi Y.
        Effect of target temperature management at 32–34 °C in cardiac arrest patients considering assessment by regional cerebral oxygen saturation: a multicenter retrospective cohort study.
        Resuscitation. 2018; 126: 185-190
        • Morrison L.J.
        • Deakin C.D.
        • Morley P.T.
        • Callaway C.W.
        • Kerber R.E.
        • Kronick S.L.
        • et al.
        Advanced life support chapter collaborators. Part 8: advanced life support: 2010 international consensus on cardiopulmonary resuscitation and emergency cardiovascular care science with treatment recommendations.
        Circulation. 2010; 122 (Oct 19): S345-S421
        • Elmer J.
        • Callaway C.W.
        The brain after cardiac arrest.
        Sem Neurol. 2017; 37: 19-24
        • van den Brule J.M.
        • Vinke E.
        • van Loon L.M.
        • van der Hoeven J.G.
        • Hoedemaekers C.W.
        Middle cerebral artery flow, the critical closing pressure, and the optimal mean arterial pressure in comatose cardiac arrest survivors-An observational study.
        Resuscitation. 2017; 110: 85-89
        • Adrie C.
        • Cariou A.
        • Mourvillier B.
        • et al.
        Predicting survival with good neurological recovery at hospital admission after successful resuscitation of out-of-hospital cardiac arrest: the OHCA score.
        Eur Heart J. 2006; 27: 2840-2845
        • Chan P.S.
        • Spertus J.A.
        • Krumholz H.M.
        • et al.
        A validated prediction tool for initial survivors of in-hospital cardiac arrest.
        Arch Intern Med. 2012; 172: 947-953
        • Ebell M.H.
        • Jang W.
        • Shen Y.
        • Geocadin R.G.
        Get with the guidelines-resuscitation I. Development and validation of the Good Outcome Following Attempted Resuscitation (GO-FAR) score to predict neurologically intact survival after in-hospital cardiopulmonary resuscitation.
        JAMA Intern Med. 2013; 173: 1872-1878
        • Rittenberger J.C.
        • Tisherman S.A.
        • Holm M.B.
        • Guyette F.X.
        • Callaway C.W.
        An early, novel illness severity score to predict outcome after cardiac arrest.
        Resuscitation. 2011; 82: 1399-1404
        • Coppler P.J.
        • Elmer J.
        • Calderon L.
        • Sabedra A.
        • Doshi A.A.
        • Callaway C.W.
        • et al.
        Post cardiac arrest service: validation of the Pittsburgh cardiac arrest category illness severity score.
        Resuscitation. 2015; 89: 86-92
        • Perkins G.D.
        • Jacobs I.G.
        • Nadkarni V.M.
        • Berg R.A.
        • Bhanji F.
        • Biarent D.
        • et al.
        Utstein Collaborators. Cardiac arrest and cardiopulmonary resuscitation outcome reports: update of the Utstein Resuscitation Registry Templates for Out-of-Hospital Cardiac Arrest: a statement for healthcare professionals from a task force of the International Liaison Committee on Resuscitation (American Heart Association, European Resuscitation Council, Australian and New Zealand Council on Resuscitation, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa, Resuscitation Council of Asia); and the American Heart Association Emergency Cardiovascular Care Committee and the Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation.
        Circulation. 2015; 132 (Sep 29): 1286-1300