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Biobehavioral measures as outcomes: a cautionary tale.

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    Biobehavioral measures like pain and agitation showed significant improvement in nursing home residents with acute psychotic symptoms. Salivary cortisol, however, was not consistently responsive to therapy, highlighting the need to validate biomarkers in specific patient groups.

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    Area of Science:

    • Gerontology
    • Psychiatry
    • Health Services Research

    Background:

    • Biobehavioral measures are increasingly used as outcomes in healthcare intervention studies.
    • Assessing the responsiveness of biomarkers like salivary cortisol and observational measures is crucial for evaluating treatment efficacy.
    • Nursing home residents present unique challenges for outcome measurement due to co-existing conditions.

    Purpose of the Study:

    • To examine the effect size (ES) of salivary cortisol and observation-based measures of pain and agitation.
    • To compare treatment effects on these biobehavioral outcomes in nursing home residents with and without acute psychotic symptoms.
    • To determine the responsiveness of biomarkers to therapy in specific patient populations.

    Main Methods:

    • Analysis of effect size (ES) values for salivary cortisol and observational pain/agitation measures.
    • Pre- to post-treatment comparisons were conducted separately for two groups: nursing home residents with acute psychotic symptoms and those without.
    • Evaluation of biomarker responsiveness within the study's context and populations.

    Main Results:

    • Large positive effects were observed for pain and agitation measures in residents with acute psychotic symptoms.
    • Small-to-medium positive effects were found for pain and agitation in residents without acute psychotic symptoms.
    • Effect sizes for salivary cortisol measures were not consistently positive across both groups.

    Conclusions:

    • Observational measures of pain and agitation are responsive to interventions in nursing home residents, particularly those with acute psychotic symptoms.
    • Salivary cortisol may not be a consistently reliable biomarker for treatment response in this population.
    • Further research is needed to validate biomarker responsiveness before using them to estimate minimum clinically important differences.