Clinical Trial Measure

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A Clinical Trial Measure is a measure that is related to the quantification or classification of a test subject's clinical response to a medical intervention/treatment.



References

2014

2007

How Should We Measure Medication Adherence in Clinical Trials and Practice?]. ” Therapeutics and clinical risk management 3, no. 4 
    • QUOTE:
      • Objective:

        To determine if simple adherence measures, such as twenty-four hour recall and refill history, are accurate for routine use, compared to more time-consuming measures such as pill counts.

      • Main outcome measures:

        Adherence was measured by pill counts, twenty-four hour recall by patient, and refill history per computer record. Temporal changes in these adherence measures were assessed using general linear models for repeated measures.

      • Results

        Adherence was consistently greater for the experimental agent than for the statin therapy (n = 148). Mean pill count adherence for statin drug was 78.7 ± 25.2% compared to 93.5 ± 11.6% (P < 0.001) for the study agent. Refill history and twenty-four hour recall inaccurately measured adherence when compared to pill counts. Adherence, as determined by pill count, for both experimental (P = 0.029) and statin therapy (P = 0.015) showed significant variability across time in general linear models. Neither refill history nor twenty-four hour recall was sensitive to temporal changes.