Literature DB >> 15837452

Reliability, effect size, and responsiveness of health status measures in the design of randomized and cluster-randomized trials.

Paula Diehr1, Lu Chen, Donald Patrick, Ziding Feng, Yutaka Yasui.   

Abstract

BACKGROUND: New health status survey instruments are often described by their psychometric (measurement) properties, such as Validity, Reliability, Effect Size, and Responsiveness. For cluster-randomized trials, another important statistic is the Intraclass Correlation (ICC) for the instrument within clusters. Studies using better instruments can be performed with smaller sample sizes, but better instruments may be more expensive in terms of dollars, opportunity cost, or poorer data quality due to the response burden of longer instruments.
METHODS: We defined the psychometric statistics in terms of a mathematical model, and examined the power of a two-sample test as a function of the test-retest Reliability, Effect Size, Responsiveness, and Intraclass Correlation of the instrument. We examined the "cost-effectiveness" of using a one-item versus a five-item measure of mental health status.
FINDINGS: Under the standard model for measurement error, the psychometric statistics are all functions of the same error term. They are also functions of the setting in which they were estimated. In randomized trials, power is a function of Reliability and sample size, and a less reliable instrument can achieve the desired power if N is increased. In cluster-randomized trials, adequate power may be obtained by increasing the number of clusters per treatment group (and often the number of persons per cluster), as well as by choosing a more reliable instrument. The one-item measure of mental health status may be more cost-effective than the five-item measure in some situations.
CONCLUSION: If the goal is to diagnose or refer individual patients, an instrument with high Validity and Reliability is needed. In settings where the sample sizes are large or can be increased easily, any valid instrument may be cost-effective. It is likely that many published values of psychometric statistics are accurate only in settings similar to that in which they were estimated.

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Year:  2005        PMID: 15837452     DOI: 10.1016/j.cct.2004.11.014

Source DB:  PubMed          Journal:  Contemp Clin Trials        ISSN: 1551-7144            Impact factor:   2.226


  13 in total

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5.  Synchrony of change in depressive symptoms, health status, and quality of life in persons with clinical depression.

Authors:  Paula H Diehr; Ann M Derleth; Stephen P McKenna; Mona L Martin; Donald M Bushnell; Gregory Simon; Donald L Patrick
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9.  Reliability, validity, and effectiveness of center of pressure parameters in assessing stabilometric platform in subjects with incomplete spinal cord injury: a serial cross-sectional study.

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10.  BOMET-QoL-10 questionnaire for breast cancer patients with bone metastasis: the prospective MABOMET GEICAM study.

Authors:  A Barnadas; M Muñoz; M Margelí; J I Chacón; J Cassinello; S Antolin; E Adrover; M Ramos; E Carrasco; M A Jimeno; B Ojeda; X González; S González; M Constenla; J Florián; A Miguel; A Llombart; A Lluch; M Ruiz-Borrego; R Colomer; S Del Barco
Journal:  J Patient Rep Outcomes       Date:  2019-12-21
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