Measurement in Clinical Research Syllabus PART I / PART II
Anita L. Stewart, Ph.D. and Steven Gregorich, Ph.D.

Class/Title/Content

Readings and Assignments


1. Concept development and concept definitions

  • Role of concept development in measurement; importance of defining concept prior to selecting measures
  • Complexity of most concepts, how to define and depict multidimensional concepts
  • Methods for developing and specifying concepts


Class 1: Slides

Class 1 Readings

  1. Stewart AL, Nápoles-Springer A., Pérez-Stable EJ, Posner S, Bindman AB, Pinderhughes HL, and Washington AE.Interpersonal processes of care in diverse populations.  Milbank Quarterly. 1999;77:305-339. PMC2751132
  2. Mehling WE, Gopisetty V, Daubenmier J, Price CJ, Hecht FM, and Stewart A.  Body awareness: construct and self-report measures.  PLoS ONE 2009:4(5): e5614. PMC2680990
  3. Vogt DS, King DW, and King LA. Focus groups in psychological assessment: enhancing content validity by consulting members of the target population.  Psychological Assessment. 2004;16:231-243.  PMID: 15456379

Class 1 Handouts

  1. Using focus groups to develop structured surveys – annotated bibliography
  2. Matrix template for reviewing measures
  3. Measures compilations
Corresponding task on review matrix:  Define concept you are interested in measuring from your own point of view including its dimensions.  Record in “concept” box at the top of the matrix.

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2. Measurement terminology and locating specific measures

  • Measurement terminology and jargon - confusion, variation, and overlap
  • Items and response scales - things to pay attention to in items
  • Locating existing measures and finding literature on measurement properties

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Class 2: Slides
Class 2 Readings: None
Class 2 Handouts

  1. Measures compilations and reviews – annotated bibliography
  2. CADC measures resources
Corresponding task on review matrix: Locate 1 or 2 measures/instruments that assess your concept.  For each one, list name of instrument/measure and citation for original publication (row 1 of matrix)

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3. Methods of developing new measures and how to select measures for your study

  • Process of developing new measures
  • Rationale for multi-item measures (scales)
  • Scale construction methods - multitrait scaling and factor analysis
Steps in choosing appropriate measures for your study and selection criteria (including permission to use m_easures)

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Class 3: Slides
Class 3 Readings

  1. Stewart AL, Hays RD, Ware JE, Jr. Methods of constructing health measures. In: Stewart AL, Ware JE, Jr. eds. Measuring Functioning and Well-being: The Medical Outcomes Study Approach. Durham NC: Duke University Press; 1992: read pages 67-80 (scale construction).
  2. Bibliography for Chapter 3. 
  3. Switzer GE, Wisniewski SR, Belle SH, Dew MA, Schultz R.  Selecting, developing, and evaluating research instruments.  Social Psychiatry and Psychiatric Epidemiology. 1999;34. PMID: 10501709             Read pages 399-404.

Corresponding task on review matrix: Complete rows 2-12 on the matrix.

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4. Basic psychometric characteristics (variability, reliability, and interpretability)

  • Concepts of error, sources of error and bias in measures
  • Indicators of variability, reasons for poor variability
  • Indicators of reliability
  • Interpretability of scores

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Class 4: Slides
Class 4 Readings

  1. Stewart AL, Hays RD, Ware JE, Jr. Methods of constructing health measures (same chapter as in class 3).  Read pages 81-85 (reliability).
Corresponding task on review matrix:  Complete rows 13-19 (interpretability, nature of samples on which it has been tested, variability and central tendency, and reliability). 

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5. Additional psychometric characteristics (validity and bias, responsiveness and sensitivity to change)

  • Types of validity in health assessment, focus on construct validity
  • How bias affects validity; sources of bias 
  • Sensitivity and responsiveness to change

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Class 5: Slides
Class 5 Readings

  1. Stewart AL, Hays RD, Ware JE, Jr. Methods of validating health measures. In: Stewart AL, Ware JEJ, eds. Measuring Functioning and Well-being: The Medical Outcomes Study Approach. Durham NC: Duke University Press; 1992. 309-324.
  2. NOTE: bibliography at end of readings for class 3.
  3. Sechrest L.  Validity of measures is no simple matter.  Health Services Research, 2005;40(5):1584-1604. PMC1361215
  4. Farivar SS, Liu H, and Hays RD.  Half standard deviation estimate of the minimally important difference in HRQOL scores? Expert Review of Pharmacoeconomics & Outcomes Research. 2004;4(5):515-523.
Corresponding task on review matrix: Complete rows 20-26 (validity, responsiveness/sensitivity to change, scoring and costs).