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Open Access 01-12-2006 | Commentary

Extending basic principles of measurement models to the design and validation of Patient Reported Outcomes

Authors: Mark J Atkinson, Richard D Lennox

Published in: Health and Quality of Life Outcomes | Issue 1/2006

Abstract

A recently published article by the Scientific Advisory Committee of the Medical Outcomes Trust presents guidelines for selecting and evaluating health status and health-related quality of life measures used in health outcomes research. In their article, they propose a number of validation and performance criteria with which to evaluate such self-report measures. We provide an alternate, yet complementary, perspective by extending the types of measurement models which are available to the instrument designer. During psychometric development or selection of a Patient Reported Outcome measure it is necessary to determine which, of the five types of measurement models, the measure is based on; 1) a Multiple Effect Indicator model, 2) a Multiple Cause Indicator model, 3) a Single Item Effect Indicator model, 4) a Single Item Cause Indicator model, or 5) a Mixed Multiple Indicator model. Specification of the measurement model has a major influence on decisions about item and scale design, the appropriate application of statistical validation methods, and the suitability of the resulting measure for a particular use in clinical and population-based outcomes research activities.

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Aiken LH, Sloane DM, Lake ET, Sochalski J, Weber AL: Organization and outcomes of inpatient AIDS care. Med Care 1999, 37: 760–772. 10.1097/00005650-199908000-00006PubMedCrossRef

Asadi-Lari M, Tamburini M, Gray D: Patients' needs, satisfaction, and health related quality of life: towards a comprehensive model. Health Qual Life Outcomes 2004, 2: 32. 10.1186/1477-7525-2-32PubMedCentralPubMedCrossRef

Chernof BA, Sherman SE, Lanto AB, Lee ML, Yano EM, Rubenstein LV: Health habit counseling amidst competing demands: effects of patient health habits and visit characteristics. Med Care 1999, 37: 738–747. 10.1097/00005650-199908000-00004PubMedCrossRef

Assessing health status and quality-of-life instruments: attributes and review criteria Qual Life Res 2002, 11: 193–205. 10.1023/A:1015291021312

Nunnally JC: Psychometric Theory. 2nd edition. New York, McGraw-Hill; 1978.

Mastrandrea F, Pecora S, Scatena C, Cadario G: Methodology and potential pitfalls in allergic diseases study designs: measurements for the assessment of the overall severity of atopic dermatitis--the four step severity score (FSSS), SCORAD-related, electronic system, for the simple and rapid evaluation of the skin and mucosal allergic inflammation. Allerg Immunol (Paris) 2005, 37: 357–361.

Van Breukelen GJ, Vlaeyen JW: Norming clinical questionnaires with multiple regression: the Pain Cognition List. Psychol Assess 2005, 17: 336–344. 10.1037/1040-3590.17.3.336PubMedCrossRef

Wolfe F, Skevington SM: Measuring the epidemiology of distress: the rheumatology distress index. J Rheumatol 2000, 27: 2000–2009.PubMed

Sawrie SM, Marson DC, Boothe AL, Harrell LE: A method for assessing clinically relevant individual cognitive change in older adult populations. J Gerontol B Psychol Sci Soc Sci 1999, 54: 116–124.CrossRef

10.

Greiner M, Gardner IA: Epidemiologic issues in the validation of veterinary diagnostic tests. Prev Vet Med 2000, 45: 3–22. 10.1016/S0167-5877(00)00114-8PubMedCrossRef

11.

Kee F, Patterson CC, Wilson AE, McConnell JM, Wheeler SM, Watson JD: Judgment analysis of prioritization decisions within a dialysis program in one United Kingdom region. Med Decis Making 2002, 22: 140–151. 10.1177/02729890222063026PubMedCrossRef

12.

Maddala T, Phillips KA, Reed JF: An experiment on simplifying conjoint analysis designs for measuring preferences. Health Econ 2003, 12: 1035–1047. 10.1002/hec.798PubMedCrossRef

13.

Hariharan S, Dey PK, Chen DR, Moseley HS, Kumar AY: Application of analytic hierarchy process for measuring and comparing the global performance of intensive care units. J Crit Care 2005, 20: 117–124. 10.1016/j.jcrc.2005.04.002PubMedCrossRef

14.

Nunnally J, Burnstein I: Psychometric Theory. 3rd edition. New York, McGraw-Hill; 1994.

15.

Cronbach LJ, Meehl PE: Construct validity in psychological tests. Psychological Bulletin 1955, 52: 281–302. 10.1037/h0040957PubMedCrossRef

16.

Westen D, Rosenthal R: Improving construct validity: Cronbach, Meehl, and Neurath's ship. Psychol Assess 2005, 17: 409–412. 10.1037/1040-3590.17.4.409PubMedCrossRef

17.

Smith GT: On construct validity: issues of method and measurement. Psychol Assess 2005, 17: 396–408. 10.1037/1040-3590.17.4.396PubMedCrossRef

18.

Atkinson MJ, Sinha A, Hass SL, Colman SS, Kumar RN, Brod M, Rowland CR: Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes 2004, 2: 12. 10.1186/1477-7525-2-12PubMedCentralPubMedCrossRef

19.

Atkinson MJ, Wishart PM, Wasil BI, Robinson JW: The Self-Perception and Relationships Tool (S-PRT): a novel approach to the measurement of subjective health-related quality of life. Health Qual Life Outcomes 2004, 2: 36. 10.1186/1477-7525-2-36PubMedCentralPubMedCrossRef

20.

Bruce B, Fries JF: The Health Assessment Questionnaire (HAQ). Clin Exp Rheumatol 2005, 23: S14-S18.PubMed

21.

Bollen KA, Lennox RD: Conventional wisdom on measurement: Structural equation perspective. Psychological Bulletin 1991, 110: 305–314. 10.1037/0033-2909.110.2.305CrossRef

22.

Atkinson MJ, Kumar R, Cappelleri JC, Hass SL: Hierarchical construct validity of the treatment satisfaction questionnaire for medication (TSQM version II) among outpatient pharmacy consumers. Value Health 2005, 8 Suppl 1: S9-S24. 10.1111/j.1524-4733.2005.00066.xPubMedCrossRef

23.

CDER: Patient-Reported Outcomes Measures: Use in Medical Product Development to Support Labeling Claims. Edited by: Research CDE. U.S. Department of Health and Human Services, Food and Drug Administration; 2006.

24.

Skevington SM, O'Connell KA: Can we identify the poorest quality of life? Assessing the importance of quality of life using the WHOQOL-100. Qual Life Res 2004, 13: 23–34. 10.1023/B:QURE.0000015317.71791.bePubMedCrossRef

25.

Schwartz CE, Rapkin BD: Reconsidering the psychometrics of quality of life assessment in light of response shift and appraisal. Health Qual Life Outcomes 2004, 2: 16. 10.1186/1477-7525-2-16PubMedCentralPubMedCrossRef

26.

Atkinson MJ, Stewart WC, Fain JM, Stewart JA, Dhawan R, Mozaffari E, Lohs J: A new measure of patient satisfaction with ocular hypotensive medications: The Treatment Satisfaction Survey for Intraocular Pressure (TSS-IOP). Health Qual Life Outcomes 2003, 1: 67. 10.1186/1477-7525-1-67PubMedCentralPubMedCrossRef

27.

Sloan JA, Aaronson N, Cappelleri JC, Fairclough DL, Varricchio C: Assessing the clinical significance of single items relative to summated scores. Mayo Clin Proc 2002, 77: 479–487.PubMedCrossRef

28.

Sloan JA, Loprinzi CL, Kuross SA, Miser AW, O'Fallon JR, Mahoney MR, Heid IM, Bretscher ME, Vaught NL: Randomized comparison of four tools measuring overall quality of life in patients with advanced cancer. J Clin Oncol 1998, 16: 3662–3673.PubMed

29.

Breslau N, Peterson EL, Kessler RC, Schultz LR: Short screening scale for DSM-IV posttraumatic stress disorder. Am J Psychiatry 1999, 156: 908–911.PubMedCrossRef

30.

Kessler RC, Abelson J, Demler O, Escobar JI, Gibbon M, Guyer ME, Howes MJ, Jin R, Vega WA, Walters EE, Wang P, Zaslavsky A, Zheng H: Clinical calibration of DSM-IV diagnoses in the World Mental Health (WMH) version of the World Health Organization (WHO) Composite International Diagnostic Interview (WMHCIDI). Int J Methods Psychiatr Res 2004, 13: 122–139. 10.1002/mpr.169PubMedCrossRef

31.

Hudziak JJ, Copeland W, Stanger C, Wadsworth M: Screening for DSM-IV externalizing disorders with the Child Behavior Checklist: a receiver-operating characteristic analysis. J Child Psychol Psychiatry 2004, 45: 1299–1307. 10.1111/j.1469-7610.2004.00314.xPubMedCrossRef

32.

Piland SG, Motl RW, Guskiewicz KM, McCrea M, Ferrara MS: Structural validity of a self-report concussion-related symptom scale. Med Sci Sports Exerc 2006, 38: 27–32. 10.1249/01.mss.0000183186.98212.d5PubMedCrossRef

33.

Cella D, Yount S, Du H, Dhanda R, Gondek K, Langefeld K, George J, Bro WP, Kelly C, Bukowski R: Development and validation of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI). J Support Oncol 2006, 4: 191–199.PubMed

34.

Webster K, Cella D, Yost K: The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: properties, applications, and interpretation. Health Qual Life Outcomes 2003, 1: 79. 10.1186/1477-7525-1-79PubMedCentralPubMedCrossRef

35.

Op de Coul BM, Ackerstaff AH, van As CJ, van den Hoogen FJ, Meeuwis CA, Manni JJ, Hilgers FJ: Quality of life assessment in laryngectomized individuals: do we need additions to standard questionnaires in specific clinical research projects? Clin Otolaryngol 2005, 30: 169–175. 10.1111/j.1365-2273.2004.00932.xPubMedCrossRef

36.

Justice AC, Holmes W, Gifford AL, Rabeneck L, Zackin R, Sinclair G, Weissman S, Neidig J, Marcus C, Chesney M, Cohn SE, Wu AW: Development and validation of a self-completed HIV symptom index. J Clin Epidemiol 2001, 54 Suppl 1: S77-S90. 10.1016/S0895-4356(01)00449-8PubMedCrossRef

37.

Hollen PJ, Gralla RJ, Liepa AM, Symanowski JT, Rusthoven JJ: Adapting the Lung Cancer Symptom Scale (LCSS) to mesothelioma: using the LCSS-Meso conceptual model for validation. Cancer 2004, 101: 587–595. 10.1002/cncr.20315PubMedCrossRef

38.

Hu WH, Lam KF, Wong YH, Lam CL, HUIi WM, Lai KC, Wong BC, Lam SK: The Hong Kong index of dyspepsia: a validated symptom severity questionnaire for patients with dyspepsia. J Gastroenterol Hepatol 2002, 17: 545–551. 10.1046/j.1440-1746.2002.02713.xPubMedCrossRef

39.

Walsh TL, Hanscom B, Lurie JD, Weinstein JN: Is a condition-specific instrument for patients with low back pain/leg symptoms really necessary? The responsiveness of the Oswestry Disability Index, MODEMS, and the SF-36. Spine 2003, 28: 607–615. 10.1097/00007632-200303150-00017PubMed

40.

Vieira AP, Lawrence HP, Limeback H, Sampaio FC, Grynpas M: A visual analog scale for measuring dental fluorosis severity. J Am Dent Assoc 2005, 136: 895–901.PubMedCrossRef

41.

Ranhoff AH, Gjoen AU, Mowe M: Screening for malnutrition in elderly acute medical patients: the usefulness of MNA-SF. J Nutr Health Aging 2005, 9: 221–225.PubMed

42.

Trauer T, Mackinnon A: Why are we weighting? The role of importance ratings in quality of life measurement. Qual Life Res 2001, 10: 579–585. 10.1023/A:1013159414364PubMedCrossRef

43.

McGrath C, Bedi R: Why are we "weighting"? An assessment of a self-weighting approach to measuring oral health-related quality of life. Community Dent Oral Epidemiol 2004, 32: 19–24. 10.1046/j.0301-5661.2003.00110.xPubMedCrossRef

44.

Kessler RC, Adler L, Ames M, Demler O, Faraone S, Hiripi E, Howes MJ, Jin R, Secnik K, Spencer T, Ustun TB, Walters EE: The World Health Organization Adult ADHD Self-Report Scale (ASRS): a short screening scale for use in the general population. Psychol Med 2005, 35: 245–256. 10.1017/S0033291704002892PubMedCrossRef

45.

Hirsch S, Frank TL, Shapiro JL, Hazell ML, Frank PI: Development of a questionnaire weighted scoring system to target diagnostic examinations for asthma in adults: a modelling study. BMC Fam Pract 2004, 5: 30. 10.1186/1471-2296-5-30PubMedCentralPubMedCrossRef

46.

Miller JD, Bagby RM, Pilkonis PA, Reynolds SK, Lynam DR: A simplified technique for scoring DSM-IV personality disorders with the Five-Factor Model. Assessment 2005, 12: 404–415. 10.1177/1073191105280987PubMedCrossRef

Title: Extending basic principles of measurement models to the design and validation of Patient Reported Outcomes
Authors: Mark J Atkinson
Richard D Lennox
Publication date: 01-12-2006
Publisher: BioMed Central
Published in: Health and Quality of Life Outcomes / Issue 1/2006
Electronic ISSN: 1477-7525
DOI: https://doi.org/10.1186/1477-7525-4-65

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Extending basic principles of measurement models to the design and validation of Patient Reported Outcomes

Abstract

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