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    28-Randomised Controlled Trial-YangBF 09.5.12

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    sanjivdas
    This document discusses randomized controlled trials (RCTs), including their purpose, principles, study design considerations, and advantages/disadvantages. RCTs aim to compare the effectiveness of specific treatments by randomly allocating patients to treatment and control groups. Key aspects of RCTs include placebos, blinding patients and staff, collecting outcome data on factors like survival rates and side effects, and analyzing results using statistical tests. While providing strong evidence, RCTs also have disadvantages like high costs and needing large patient samples.

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    28-Randomised Controlled Trial-YangBF 09.5.12

    Uploaded by

    sanjivdas
    39 views14 pages
    This document discusses randomized controlled trials (RCTs), including their purpose, principles, study design considerations, and advantages/disadvantages. RCTs aim to compare the effectiveness of specific treatments by randomly allocating patients to treatment and control groups. Key aspects of RCTs include placebos, blinding patients and staff, collecting outcome data on factors like survival rates and side effects, and analyzing results using statistical tests. While providing strong evidence, RCTs also have disadvantages like high costs and needing large patient samples.

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    Epidemiology

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    This document discusses randomized controlled trials (RCTs), including their purpose, principles, study design considerations, and advantages/disadvantages. RCTs aim to compare the effectiveness of specific treatments by randomly allocating patients to treatment and control groups. Key aspects of RCTs include placebos, blinding patients and staff, collecting outcome data on factors like survival rates and side effects, and analyzing results using statistical tests. While providing strong evidence, RCTs also have disadvantages like high costs and needing large patient samples.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    39 views14 pages

    28-Randomised Controlled Trial-YangBF 09.5.12

    Uploaded by

    sanjivdas
    This document discusses randomized controlled trials (RCTs), including their purpose, principles, study design considerations, and advantages/disadvantages. RCTs aim to compare the effectiveness of specific treatments by randomly allocating patients to treatment and control groups. Key aspects of RCTs include placebos, blinding patients and staff, collecting outcome data on factors like survival rates and side effects, and analyzing results using statistical tests. While providing strong evidence, RCTs also have disadvantages like high costs and needing large patient samples.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    of 14

    23.

    Randomised controlled trial


    Dept. Epidemiology
    School of Public Health
    Jining Medical College
    12 May 2009
    Classification of mothod in epidemiology

     Descriptive epidemiology

     Analytical epidemiology

     Experimental studies or clinical trial

    (Randomised controlled trial,RCT)


    Destination

     To compare the effectiveness of a specific


    treatment

     Preventional (or prophylactic) interventions


    Principle of RCT

    Example:

    Group A (new anti-cancer drug) Length of survival


    Side-effects
    Group B (current treat) Quality of life

    Some trials use three or more groups


     Placebo: non- treatment called a placebo. A placebo is
    effectively a dummy treatment which appears to be real.

     Blind:The patients do not know whether they have been


    allocated to the group receiving a new treatment, or an
    old one, or a placebo.

     Double-blind RCT: Neither the patients nor the medical


    staff know which intervention had been allocated.
     Cross-over trial
     Subjects receive one intervention for a certain period,

    and then be changed over to another intervention.

     Multi-centre trials
     Studying subjects at more than one site

     Increase the sample size


     Meta-analysis :
     To summarize the results of several trials
     To “pool together” the results of trials
     Overall picture of an intervention’s efficacy

    Drawbacks:
    (1)publication bias: postive outcome more likely to be
    published.
    (2)quality of studies, quality of life and cost-
    effectiveness are not normally evaluated

    Systematic reviews: gold standard of clinical evidence


    Study design

     Eligibility criteria:
    patients who are most likely to benefit
    from the treatment
    they will not represent the whole population
    of patients

     End of the trial


     changes in subjects’ condition, death or
    other physical status
    Follow up:until the end-point is reached.

    Sample: calculated using formula.


     Ethical issues :
    Subjects should not be exposed to known
    or potential hazards
    Unacceptable to withhold treatment from
    subjects in a control group

    Treaty of Helsinke
    IRB approval
    Informed consent
     Subjects

     The sample of subjects should be

    representative of the population as a whole.


    Randomly allocated to a particular treatment arm.

    To ensure that their personal characteristics

    have no influence over the treatment arm


     Data collection

    Agreed points throughout the trial.


    To check patient compliance with any treatments given,
    including placebos.
    Information about many factors,
    including any side-effects of treatment.
     Data analysis

    For continuous data: hypothesis tests,

    confidence intervals.

    For categorical data: Chi-squared test,

    relative risk and

    number needed to treat.

    For other outcome variables


     Some advantages and disadvantages of
    randomized controlled trials
    Advantages Disadvantages
    Allows effectiveness of a new Expensive and complicated to
    treatment to be evaluated. perform.
    Provides strong evidence of Patients may refuse treatment –
    effectiveness. non-compliance can affect
    results.
    Less prone to confounding than A large sample size is needed.
    other study designs.
    Careful attention to ethical issues
    is needed.
    Informed patient consent is
    essential.

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