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. 2012 May;74(4):387-97.
doi: 10.1097/PSY.0b013e3182571faa.

Expanding options for developing outcome measures from momentary assessment data

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Expanding options for developing outcome measures from momentary assessment data

Arthur A Stone et al. Psychosom Med. 2012 May.

Abstract

Objective: We propose several different patient-reported outcomes (PROs) from momentary, real-time collection of symptom data. In addition to the mean of momentary reports of symptoms, other types of summaries can reflect different aspects of the symptom experience.

Methods: With secondary analyses of two studies of patients with chronic pain assessed with real-time methods, we demonstrate principles for developing outcomes that summarize symptom experience during a 1-week period. These studies focused on pain intensity, which is used to demonstrate methods for creating summary momentary measures.

Results: Analyses from the first study (Pain 2008;139:146-57) yielded outcome measures based on the mean, median, 90th percentile, maximum, standard deviation, proportion of reports with no pain, proportion of reports with pain more than 50 (on a 0- to 100-point scale), and time-contingent measures. The second study examined the performance of these measures (and the mean) in a longitudinal study, in which some patients changed treatment (n = 78), making pain reduction likely, whereas others had no treatment change (n = 27). The measure that best discriminated the groups was the proportion of momentary reports without pain (effect size = 0.50), closely followed by the mean of all reports (effect size = 0.45). Most measures also correlated with patients' global impression of their change (between 0.39 and 0.55, except for standard deviation [0.13]).

Conclusions: These analyses suggest that momentary symptom data can be useful for developing new PROs that reflect symptom experience other than the mean. They highlight knowledge gleaned from real-time studies, which deepens our understanding of symptoms by demonstrating which changes in symptoms are associated with overall perceived change.

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Figures

Figure 1.
Figure 1.
Histograms of nine randomly chosen participants showing the distribution of their random assessments of pain intensity during the first week of participation, Study 1.
Figure 2.
Figure 2.
Histograms for n = 106 patients in Study 1: summary measures of pain.
Figure 3.
Figure 3.
Histograms of change scores based on summary measures in Study 2. Positive values indicated reductions in pain.

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References

    1. Rothman M, Burke L, Erickson P, Leidy NK, Patrick DL, Petrie CD.Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR good research practices for evaluating and documenting content validity for the use of existing instruments and their modification PRO Task Force Report. Value Health 2009;12:1075–83. - PubMed
    1. Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol 2008;4:1–32. - PubMed
    1. Stone AA, Broderick JE. Real-time data collection for pain: appraisal and current status. Pain Med 2007;8(Suppl 3):S85–93. - PubMed
    1. Stone AA, Shiffman S, Atienza A, Nebling L, editors. The Science of Real-time Data Capture: Self-reports in Health Research. New York, NY: Oxford Univeristy Press; 2007.
    1. Guidance for Industry. Patient-reported outcome measures: Use in medical product development to support labeling claims. Silver Sprineddg, MD: US Department of Health and Human Services; 2009; Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati.... Accessed April 21, 2012.

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