6. Outcome measures For hypothesis-testing studies, specify the primary outcome measure, i.e. the outcome measure that was used to determine the sample size. examples
Example 1
“The primary outcome of this study will be forelimb function assessed with the staircase test. Secondary outcomes constitute Rotarod performance, stroke volume (quantified on MR imaging or brain sections, respectively), diffusion tensor imaging (DTI) connectome mapping, and histological analyses to measure neuronal and microglial densities, and phagocytic activity…The study is designed with 80% power to detect a relative 25% difference in pellet-reaching performance in the Staircase test.” [1]
Example 2
“The primary endpoint of this study was defined as left ventricular ejection fraction (EF) at the end of follow-up, measured by magnetic resonance imaging (MRI). Secondary endpoints were left ventricular end diastolic volume and left ventricular end systolic volume (EDV and ESV) measured by MRI, infarct size measured by ex vivo gross macroscopy after incubation with triphenyltetrazolium chloride (TTC) and late gadolinium enhancement (LGE) MRI, functional parameters serially measured by pressure volume (PV-)loop and echocardiography, coronary microvascular function by intracoronary pressure- and flow measurements and vascular density and fibrosis on histology. Based on a power calculation (estimated effect 7.5% [6], standard deviation of 5%, a power of 0.9 and alpha of 0.05) 8 pigs per group were needed.” [2]
- Emmrich J, Neher J, Boehm-Sturm P, Endres M, Dirnagl U and Harms C (2018). Stage 1 Registered Report: Effect of deficient phagocytosis on neuronal survival and neurological outcome after temporary middle cerebral artery occlusion (tMCAo) [version 3; referees: 2 approved]. F1000Research. doi: 10.12688/f1000research.12537.3
- Jansen of Lorkeers SJ, Gho JMIH, Koudstaal S, van Hout GPJ, Zwetsloot PPM, van Oorschot JWM, van Eeuwijk ECM, Leiner T, Hoefer IE, Goumans M-J, Doevendans PA, Sluijter JPG and Chamuleau SAJ (2015). Xenotransplantation of Human Cardiomyocyte Progenitor Cells Does Not Improve Cardiac Function in a Porcine Model of Chronic Ischemic Heart Failure. Results from a Randomized, Blinded, Placebo Controlled Trial. PLOS ONE. doi: 10.1371/journal.pone.0143953