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Should study subjects see their previous responses?

G H Guyatt, L B Berman, M Townsend

    Journal of Chronic Diseases
    |January 1, 1985
    PubMed
    Summary
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    Providing patients access to previous responses on quality of life questionnaires significantly reduces measurement variability. This informed approach can decrease the sample size needed for clinical trials evaluating health outcomes.

    Area of Science:

    • Health outcomes research
    • Clinical trial methodology
    • Patient-reported outcomes

    Background:

    • Quality of life questionnaires are crucial for assessing patient well-being in clinical research.
    • The method of questionnaire administration, whether patients can see previous responses or not, may influence results.
    • Understanding the impact of response availability is key to optimizing data collection in clinical trials.

    Purpose of the Study:

    • To compare the effectiveness of two questionnaire administration methods: informed (previous responses available) versus blind (previous responses unavailable).
    • To evaluate the impact of these methods on the measurement of quality of life in patients with cardiorespiratory and lung diseases.
    • To determine if the informed method can reduce the sample size required for detecting changes in quality of life.

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    Main Methods:

    • Administered blind and informed versions of a quality of life questionnaire to two patient groups.
    • Group 1: 43 stable patients with chronic cardiorespiratory disease, assessed at three fortnightly intervals.
    • Group 2: 13 patients with chronic lung disease, assessed before and after therapy optimization.

    Main Results:

    • In stable patients, the informed strategy significantly decreased measurement variance for dyspnea, fatigue, and emotional function.
    • Improvements in dyspnea, fatigue, and emotional function during treatment optimization were comparable between blind and informed methods.
    • The informed approach demonstrated a potential to reduce the necessary sample size for detecting quality of life changes.

    Conclusions:

    • Allowing patients to view their previous questionnaire responses enhances the reliability of quality of life measurements.
    • The informed method is particularly beneficial for stable patient populations where reducing measurement error is critical.
    • This strategy offers a valuable tool for improving the efficiency and statistical power of clinical trials.