Lecture 7 (Prof Rovina) Video 1: Planning the measurements (precision, accuracy, and validity) Phenomena will be analyzed statistically. Garbage in garbage out. Validity of the study ditentukan oleh variables. Jika mau tau kanker prostat yaitu ukur PSA, drug concentration utk drug trial. Measurement scale: pakai alat apa, jenis variable nya apa Type exp Categorial nominal Gender, blood type Categorical ordinal Degree of pain Continuous/discrete Weight, BMI Descriptive stat Count, % Information content Lower Above, median Above, means, SD Intermediate Higher Measurement scale: what to choose? Video 2: Measurement: precision and accuracy Precise measurement: reproducibility, reliability, consistency Free/lack of random error (variability) Based on sample size Quantified as confident interval (CI) Accurate measurement (validity) Free/lack of systematic error (bias) External validity How to improve? Enhancing precision: standardizing the measurement methods (SOP), training and certifying the observers, refining the instruments, automating the instruments, repetition of measurement. Enhancing accuracy: blinding, calibrating the instrument, making unobtrusive measurement (subject unaware of being observed) In clinical trial: QA quality assurance: to think ahead before error happen, membuat SOP QC: to act after error happens and how to prevent it in the future (CAPA correction action prevention action) Clinical monitoring: to make sure research is conducted according to the approved protocol and GCP