Sample Size Estimation

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Nayyar Kazmi

How to determine Sample Size in Biostatistics

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Sample Size Estimation Nayyar Raza Kazmi

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Sample size Calculation: Objectives: Calculate sample size according to particular type of research, and purpose. Identify and select various software to calculate sample size according to particular type of research, and purpose. Why to calculate sample size? To show that under certain conditions, the hypothesis test has a good chance of showing a desired difference (if it exists) To show to the IRB committee and funding agency that the study has a reasonable chance to obtain a conclusive result To show that the necessary resources (human, monetary, time) will be minimized and well utilized. Most Important: sample size calculation is an educated guess It is more appropriate for studies involving hypothesis testing There is no magic involved; only statistical and mathematical logic and some algebra Researchers need to know something about what they are measuring and how it varies in the population of interest. SAMPLE SIZE: How many subjects are needed to assure a given probability of detecting a statistically significant effect of a given magnitude if one truly exists? POWER: If a limited pool of subjects is available, what is the likelihood of finding a statistically significant effect of a given magnitude if one truly exists? Before We Can Determine Sample Size We Need To Answer The Following: 1. What is the primary objective of the study? 2. What is the main outcome measure? Is it a continuous or dichotomous outcome? 3. How will the data be analyzed to detect a group difference? 4. How small a difference is clinically important to detect? 5. How much variability is in our target population? 6. What is the desired  and ? 7. What is the anticipated drop out and non-response % ? Where do we get this knowledge? Previous published studies Pilot studies If information is lacking, there is no good way to calculate the sample size. Type I error: Rejecting H0 when H0 is true : The type I error rate. Type II error: Failing to reject H0 when H0 is false : The type II error rate Power (1 - ): Probability of detecting group difference given the size of the effect () and the sample size of the trial (N). Estimation of Sample Size by Three ways: By using (1) Formulae (manual calculations) (2) Sample size tables or Nomogram (3) Softwares. SAMPLE SIZE FOR ADEQUATE PRECISION: In a descriptive study, Summary statistics (mean, proportion) Reliability (or) precision By giving “confidence interval” Wider the C.I – sample statistic is not reliable and it may not give an accurate estimate of the true value of the population parameter. Sample size calculation for cross sectional studies/surveys: Cross sectional studies or cross sectional survey are done to estimate a population parameter like prevalence of some disease in a community or finding the average value of some quantitative variable in a population. Sample size formula for qualitative variable and quantities variable are different.

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These are simplified slides discussing the regulation of cardiac output and venous return. Learning objectives: 1. Comprehend the determinants of cardiac output and factors affecting cardiac output 2. Comprehend the factors affecting stroke volume and heart rate and total peripheral resistance 3. Identify the factors regulating venous return 4. Discuss the causes of high and low output cardiac failure 5. Enlist the functions of veins and recognise the significance of venous reservoirs Study Resources: 1. Chapter 20, Guyton and Hall Textbook of Medical Physiology, 14th edition 2. Chapter 30 and 32, Ganong’s Review of Medical Physiology, 26th edition 3. Chapter 10, Human Physiology by Lauralee Sherwood, 9th edition 4. Physiology, Cardiac Output - StatPearls https://www.ncbi.nlm.nih.gov/books/NBK470455/

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In this lecture on circulatory shock, Dr. Faiza, an Assistant Professor of Physiology, delves into the profound implications of inadequate blood flow throughout the body, leading to tissue damage. The session begins by defining circulatory shock and elucidating its physiological causes, including decreased cardiac output, diminished blood volume, decreased vascular tone, obstruction to blood flow, excess metabolic rate, and abnormal perfusion patterns. Dr. Faiza categorizes shock into various types, such as cardiogenic shock, hypovolemic shock, neurogenic shock, obstructive shock, anaphylactic shock, and septic shock, and explores the pathophysiological basis of each. Furthermore, the lecture examines the stages of shock, from the non-progressive phase where compensatory mechanisms aim for full recovery to the progressive phase where shock worsens steadily without intervention, potentially leading to irreversible damage. Dr. Faiza discusses therapeutic interventions for shock, including replacement therapy, blood and plasma transfusion, sympathomimetic drugs, and other adjunctive treatments like head-down positioning, oxygen therapy, and glucocorticoids.

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5-year survival of GCP after radical procedures significantly depended on: 1) PT “early-invasive cancer”; 2) PT N0--N12; 3) Cell Ratio Factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) GC cell dynamics; 9) GC characteristics; 10) tumor localization; 11) anthropometric data; 12) surgery type. Optimal diagnosis and treatment strategies for GC are: 1) screening and early detection of GC; 2) availability of sufficient quantity of experienced abdominal surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunotherapy for GCP with unfavorable prognosis.

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