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    This document discusses formulas and calculations for determining sample size in a clinical trial that involves two treatment groups. It states that for a power of 80% and significance level of 5%, the required sample size would be 16 per group based on the given parameters, for a total of 36 participants (18 in the control group and 18 in the treatment group). Recurrent itchy rashes commonly occur in infants and children and are often associated with elevated IgE levels and family history of allergies.

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    This document discusses formulas and calculations for determining sample size in a clinical trial that involves two treatment groups. It states that for a power of 80% and significance level of 5%, the required sample size would be 16 per group based on the given parameters, for a total of 36 participants (18 in the control group and 18 in the treatment group). Recurrent itchy rashes commonly occur in infants and children and are often associated with elevated IgE levels and family history of allergies.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    13 views1 page

    Sample Size3

    Uploaded by

    maheswariputri96
    This document discusses formulas and calculations for determining sample size in a clinical trial that involves two treatment groups. It states that for a power of 80% and significance level of 5%, the required sample size would be 16 per group based on the given parameters, for a total of 36 participants (18 in the control group and 18 in the treatment group). Recurrent itchy rashes commonly occur in infants and children and are often associated with elevated IgE levels and family history of allergies.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 1

    {(Z1/2)2p(1p)+(Z1)p1(1p1)+p2(1p2)}2/(p1p2)2

    = 1,96 2x0.44(10.44)+0.840.2(10.2)+0.68(10.68)/(0,48)2

    =1.96 0.49+0.84 0.38/0.23


    =(1.37+0.52)2/0.23=3.57/0.23=15.52
    masingmasingcontroldanperlakuan16sampel
    sampelsebesar10%daarijumlahsampeluntukmengantisipasiresponden
    dropout
    jaditotal2kelompok36kelompokcontrol18dankelompokperlakuan18
    recurrent itchy fairly commonly occurs during infancy and children , often associated
    with elevated levels of IgE in serum and a family history of atopy or patients

    2 ( Z Z/2 )
    2

    n
    n

    difference

    = 2(2)2 ( 0.84 + 1.96 )2


    22
    = 8 x (2.8)2
    22
    = 15.68 = 16 sample

    Kunz B, Oranje AP, Labreze L, Stalder JF, Ring J, Taieb A. Clinical


    validation and
    guidelines for the SCORAD index: Consensus
    report of the European Task Force on Atopic Dermatitis.
    Dermatology 1997; 195: 10 19.
    Sularsito SA, Djuanda S. Dermatitis. In: Djuanda A, Hamzah M, Aisah S,
    editors. Ilmu Penyakit Kulit dan Kelamin. 6th ed. Jakarta: Balai
    Penerbit FKUI; 2013. p. 129-53
    Wolff, Klause.. Fitzpatrick Color Atlas & Synopsis of Clinical Dermatology.
    6th ed. Mc Graw Hill. 2009

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