$MathMaster logo$

MathMaster

Home
general
your boss asks you to plan the sample size for a randomized double blind controlled trial in the clinical development of a

Question

Your boss asks you to plan the sample size for a randomized, double-blind, controlled trial in the clinical development of a cure for irritable bowl disease. Current standard treatment shall be compared with a new treatment in this trial. The S3-guideline of AWM demonstrated a mean change of the summary score of the validated health related quality of life questionnaire at 8 weeks of 16 with standard deviation 23 under standard treatment. You quote the drop-out rate of 11% from literature (previous phase of clinical development). Your research yielded a clinically important effect of 4 that has been found to be the Minimal Clinically Important Difference (MCID). In order to demonstrate superiority of the new treatment over standard of care, you assume that the change in of the summary score of the validated health related quality of life questionnaire follows a normal distribution, and that the standard deviation is the same for both treatments. How many patientes would one need to recruit for the trial to demonstrate the clinically interesting difference between treatments at significance level 5% with 95% power?

186

likes

932 views

Answer to a math question Your boss asks you to plan the sample size for a randomized, double-blind, controlled trial in the clinical development of a cure for irritable bowl disease. Current standard treatment shall be compared with a new treatment in this trial. The S3-guideline of AWM demonstrated a mean change of the summary score of the validated health related quality of life questionnaire at 8 weeks of 16 with standard deviation 23 under standard treatment. You quote the drop-out rate of 11% from literature (previous phase of clinical development). Your research yielded a clinically important effect of 4 that has been found to be the Minimal Clinically Important Difference (MCID). In order to demonstrate superiority of the new treatment over standard of care, you assume that the change in of the summary score of the validated health related quality of life questionnaire follows a normal distribution, and that the standard deviation is the same for both treatments. How many patientes would one need to recruit for the trial to demonstrate the clinically interesting difference between treatments at significance level 5% with 95% power?

$Expert avatar$

4.5

99 Answers

\frac{2\times\left(1.96+1.645\right)^2\times23^2}{4^2}=859.36 Therefore sample size is 860

Frequently asked questions (FAQs)

What are the vertices of the hyperbola representing the equation x^2/16 - y^2/9 = 1?

+

What is the solution to the inequality 5x - 7 > 3x + 15?

+

Math question: What is the value of log(base 2) 16?

+

New questions in Mathematics

Pedro bought 9 kg of sugar at the price of R$1.80 per kilogram, six packets of coffee at the price of R$3.90 per packet and 8 kg of rice at the price of R$2.70 per kilogram. Knowing that he paid for the purchases with a R$100.00 bill, how much change did he receive?

A person who weighs 200 pounds on earth would weigh about 32 pounds on the moon. Find the weight of a person on earth who would weigh 15 pounds on the moon.

String x = 5 Int y=2 System.out.println(x+y)

(6.2x10^3)(3x10^-6)

The mean temperature for july in H-town 73 degrees fahrenheit. Assuming that the distribution of temperature is normal what would the standart deviation have to be if 5% of the days in july have a temperature of at least 87 degrees?

Solve this mathematical problem if 3/5 of a roll of tape measures 2m. How long is the complete roll? Draw the diagram

Subscribers to the FAME magazine revealed the following preferences for three categories: Fashion 30, Athletics 24 and Business 15. Following these frequencies of observation, compute the chi-square test statistic. At the 0.05 level of significance, would you conclude they are similar?

Find the equation of the line perpendicular to −5𝑥−3𝑦+5=0 passing through the point (0,−2)

Suppose the Golf ball market is perfectly competitive and the functions are known: Q = 120 – 2Px – 2Py 0.2I Q = 2Px 40 Where I = Consumers' income ($200) and Py = Price of Good Y (40) Calculate the equilibrium elasticity: a) 1.6 b) -6 c) 6 d) 0.6

According to a survey in a country 27% of adults do not own a credit card suppose a simple random sample of 800 adults is obtained . Describe the sampling distribution of P hat , the sample proportion of adults who do not own a credit card

Substitute a=2 and b=-3 and c=-4 to evaluate 2ac/(-2b^2-a)

A company receives sales in $20 per book and $18 per calculator. The per unit cost to manufacture each book and calculator are $5 and 4$ respectively. The monthly (30 day) cost must not exceed $27000 per month. If the manufacturing equipment used by the company takes five minutes to produce a book and 15 minutes to produce a calculator, how many books and calculators should the company produce to maximise profit? Please solve graphically and

The points (-5,-4) and (3,6) are the ends of the diameter of the circle calculate subequation

Show work on 4108 divided by 4

(a) List the set of possible rational zeros of the polynomial function F(x) = 2x3 - 11x2 + 13x - 4. (b) Find all rational zeros of F(x). Only do part B

Give an example of a function defined in R that is continuous in all points, except in the set Z of integers.

Solve for B write your answer as a fraction or as a whole number. B-1/7=4

00 piece jigsaw puzzle. the completed puzzle is 10x10. each piech connects to at least 2 other pieces. i plan to assemble by taking pieces out of box one by one. if i've already taken out 2 pieces that dont directly connect, what is the minimum number of additional pieces that i need to draw to in order to guarentee that the original 2 pieces connect?

Construct a set of six pieces of data with mean, median, and midrange of 67 and where no two pieces of data are the same.