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Trials for Mechanical Circulatory Support Devices in Cardiogenic Shock

      Planning future trials on the basis of conditional power of a meta-analysis quantifies the potential impact of a future study of specific sample size on the results of the meta-analysis of existing evidence.
      • Roloff V
      • Higgins JP
      • Sutton AJ.
      Planning future studies based on the conditional power of a meta-analysis.
      ,
      • Nikolakopoulou A
      • Mavridis D
      • Salanti G.
      Using conditional power of network meta-analysis (NMA) to inform the design of future clinical trials.
      Conditional planning of future randomized clinical trials (RCTs) appears to be an attractive approach from methodologic, ethical, and pragmatic perspectives because it may determine the required sample size in a new trial and subsequently, it may result in fewer subjects and required resources by avoiding unnecessary research efforts.
      • Roloff V
      • Higgins JP
      • Sutton AJ.
      Planning future studies based on the conditional power of a meta-analysis.
      ,
      • Nikolakopoulou A
      • Mavridis D
      • Salanti G.
      Using conditional power of network meta-analysis (NMA) to inform the design of future clinical trials.
      Such an approach can be of special importance for interventional procedures and medical conditions with poor survival rates and obvious obstacles in patients’ recruitment.
      • Lauder L
      • da Costa BR
      • Ewen S
      • Scholz SS
      • Wijns W
      • Lüscher TF
      • Serruys PW
      • Edelman ER
      • Capodanno D
      • Böhm M
      • Jüni P
      • Mahfoud F.
      Randomized trials of invasive cardiovascular interventions that include a placebo control: a systematic review and meta-analysis.
      • Enezate T
      • Eniezat M
      • Thomas J.
      Utilization and outcomes of temporary mechanical circulatory support devices in cardiogenic shock.
      • Khan MZ
      • Munir MB
      • Khan MU
      • Osman M
      • Agrawal P
      • Syed M
      • Ghaffar YA
      • Alharbi A
      • Khan SU
      • Balla S.
      Trends, outcomes, and predictors of revascularization in cardiogenic shock.
      • Basir MB
      • Pinto DS
      • Ziaeian B
      • Khandelwal A
      • Cowger J
      • Suh W
      • Althouse A.
      Mechanical circulatory support in acute myocardial infarction and cardiogenic shock: challenges and importance of randomized control trials.
      RCTs of temporary mechanical circulatory support (MCS) devices in patients with cardiogenic shock (CS) fall into this category.
      • Basir MB
      • Pinto DS
      • Ziaeian B
      • Khandelwal A
      • Cowger J
      • Suh W
      • Althouse A.
      Mechanical circulatory support in acute myocardial infarction and cardiogenic shock: challenges and importance of randomized control trials.
      ,
      • Ni hIci T
      • Boardman HM
      • Baig K
      • Stafford JL
      • Cernei C
      • Bodger O
      • Westaby S.
      Mechanical assist devices for acute cardiogenic shock.
      In view of obvious challenges in conducting adequately powered trials in this setting for clinically relevant outcomes, we applied conditional planning to get information related to the magnitude of the required sample size for a hypothetical future trial by incorporating small-scale underpowered trials of MCS in CS. We argue that conditional planning can properly determine the range of required sample size for different levels of powered trials and better inform investigators’ anticipations.
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