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    Checklist For Controlled Trials

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    Muhammad Iqbal
    This document provides a methodology checklist for assessing controlled trials. It includes questions about whether the study addresses a focused clinical question, whether subjects were randomly assigned to treatment groups, whether outcomes were measured consistently, and whether all subjects were analyzed in their assigned groups. The reviewer uses the checklist to evaluate the internal and external validity of the study and assign an overall assessment code of high, acceptable, low quality or unacceptable.

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    Checklist For Controlled Trials

    Uploaded by

    Muhammad Iqbal
    299 views2 pages
    This document provides a methodology checklist for assessing controlled trials. It includes questions about whether the study addresses a focused clinical question, whether subjects were randomly assigned to treatment groups, whether outcomes were measured consistently, and whether all subjects were analyzed in their assigned groups. The reviewer uses the checklist to evaluate the internal and external validity of the study and assign an overall assessment code of high, acceptable, low quality or unacceptable.

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    20150907 Checklist for Controlled Trials

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    This document provides a methodology checklist for assessing controlled trials. It includes questions about whether the study addresses a focused clinical question, whether subjects were randomly assigned to treatment groups, whether outcomes were measured consistently, and whether all subjects were analyzed in their assigned groups. The reviewer uses the checklist to evaluate the internal and external validity of the study and assign an overall assessment code of high, acceptable, low quality or unacceptable.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    299 views2 pages

    Checklist For Controlled Trials

    Uploaded by

    Muhammad Iqbal
    This document provides a methodology checklist for assessing controlled trials. It includes questions about whether the study addresses a focused clinical question, whether subjects were randomly assigned to treatment groups, whether outcomes were measured consistently, and whether all subjects were analyzed in their assigned groups. The reviewer uses the checklist to evaluate the internal and external validity of the study and assign an overall assessment code of high, acceptable, low quality or unacceptable.

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    © All Rights Reserved
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    Download as doc, pdf, or txt
    of 2

    SIGN

    Methodology Checklist 2: Controlled Trials

    Study identification (Include author, title, year of publication, journal title, pages)
    Guideline topic:

    Key Question No:

    Reviewer:

    Before completing this checklist, consider:


    1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the
    study design algorithm available from SIGN and make sure you have the correct checklist. If it is a
    controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated
    higher than 1+
    2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention
    Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
    Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):
    SECTION 1: INTERNAL VALIDITY
    In a well conducted RCT study
    1.1

    The study addresses an appropriate and clearly focused question.

    Does this study do it?


    Yes

    No

    Cant say
    1.2

    The assignment of subjects to treatment groups is randomised.

    Yes

    No

    Cant say
    1.3

    An adequate concealment method is used.

    Yes

    No

    Cant say
    1.4
    1.5

    The design keeps subjects and investigators blind about


    treatment allocation.

    Yes

    The treatment and control groups are similar at the start of the trial.

    Yes

    No

    Cant say
    No

    Cant say
    1.6
    1.7

    The only difference between groups is the treatment under


    investigation.

    Yes

    All relevant outcomes are measured in a standard, valid and


    reliable way.

    Yes

    No

    Cant say
    No

    Cant say

    1.8

    What percentage of the individuals or clusters recruited into each


    treatment arm of the study dropped out before the study was
    completed?

    1.9

    All the subjects are analysed in the groups to which they were
    randomly allocated (often referred to as intention to treat analysis).

    Yes

    No

    Cant say

    Does not apply

    Where the study is carried out at more than one site, results are
    comparable for all sites.

    Yes

    No

    Cant say

    Does not apply

    1.10

    SECTION 2: OVERALL ASSESSMENT OF THE STUDY


    2.1

    How well was the study done to minimise bias?


    Code as follows:

    High quality (++)


    Acceptable (+)
    Low quality (-)
    Unacceptable reject 0

    2.2

    Taking into account clinical considerations, your


    evaluation of the methodology used, and the
    statistical power of the study, are you certain
    that the overall effect is due to the study
    intervention?

    2.3

    Are the results of this study directly applicable to


    the patient group targeted by this guideline?

    2.4

    Notes. Summarise the authors conclusions. Add any comments on your own assessment of the
    study, and the extent to which it answers your question and mention any areas of uncertainty raised
    above.

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