Linking Clinical Variables With Health-Related Quality of Life: A Conceptual Model of Patient Outcomes
Abstract
HEALTH-related quality of life (HRQL) is increasingly used as an outcome in clinical trials, effectiveness research, and research on quality of care. Factors that have facilitated this increased usage include the accumulating evidence that measures of HRQL are valid and "reliable,"1the publication of several large clinical trials showing that these outcome measures are responsive to important clinical changes,2-5and the successful development and testing of shorter instruments that are easier to understand and administer.6-13Because these measures describe or characterize what the patient has experienced as the result of medical care, they are useful and important supplements to traditional physiological or biological measures of health status. Given this improved ability to assess patients' health status, how can physicians and health care systems intervene to improve HRQL? Implicit in the use of measures of HRQL in clinical trials and in effectiveness research is the concept that clinical
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Symptoms and side effects are the most proximally and least confounded clinical variables associated with disease and treatment; as one moves toward broader quality of life, many other confounding patient and environmental factors influence a quality of life score.
“Symptoms and side effects are the most proximally and least confounded clinical variables associated with disease and treatment; however, as one moves further away from the direct effects of disease and treatment, towards the broader construct of quality of life, many other confounding patient and environmental factors influence a quality of life score.”
The Wilson and Cleary model suggests that to be very precise and valid, distinctly different PROs should be assessed separately to maximize information and decrease overlap between constructs.
“The model suggests that to be very precise and valid, distinctly different PROs should be assessed separately to maximize information and decrease overlap between constructs.”
HRQOL is a broad, multi-faceted construct affected by many confounding variables.
“Per Wilson and Cleary, HRQOL is a broad, multi-faceted construct affected by many confounding variables [16].”
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“Teams such as Patrick and Erickson [10], Wilson and Cleary [78], Ruta and colleagues [81], and McGee et al.”
BackgroundOral health-related quality-of-life scores differ by socioeconomic status and caries experience
Chaffee, B. W., Rodrigues, P. H., Kramer, P. F., Vítolo, M. R., & Feldens, C. A. (2017) · Community Dentistry and Oral Epidemiology · doi:10.1111/cdoe.12279 · Cited by 281 · see citing works
Bayliss, E. A., Ellis, J., & Steiner, J. F. (2005) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-3-51 · Cited by 277 · see citing works
Ahmed, S., Berzon, R. A., Revicki, D. A., Lenderking, W. R., Moinpour, C. M., Basch, E., Reeve, B. B., & Wu, A. W. (2012) · Medical Care · doi:10.1097/mlr.0b013e318268aaff · Cited by 272 · see citing works
Chronic pain, depression, and quality of life: correlations and predictive value of the SF-36.
Elliott, T. E., Renier, C., & Palcher, J. A. (2003) · Pain medicine (Malden, Mass.) · doi:10.1111/j.1526-4637.2003.03040.x · Cited by 281 · see citing works
Suzuki, M., Ohyama, N., Yamada, K. N., & Kanamori, M. (2002) · Nursing and Health Sciences · doi:10.1046/j.1442-2018.2002.00123.x · Cited by 260 · see citing works
Validity of PROMIS physical function measured in diverse clinical samples
Schalet, B. D., Hays, R. D., Jensen, S. E., Beaumont, J. L., Fries, J. F., & Cella, D. F. (2016) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2015.08.039 · Cited by 257 · see citing works
Development and Validation of the Migraine‐Specific Quality of Life Questionnaire
Jhingran, P., Osterhaus, J. T., Miller, D. W., Lee, J. T., & Kirchdoerfer, L. (1998) · Headache: The Journal of Head and Face Pain · doi:10.1046/j.1526-4610.1998.3804295.x · Cited by 252 · see citing works
Anderson, K. L., & Burckhardt, C. S. (1999) · Journal of Advanced Nursing · doi:10.1046/j.1365-2648.1999.00889.x · Cited by 251 · see citing works
Husson, O., de Rooij, B. H., Kieffer, J. M., Oerlemans, S., Mols, F., Aaronson, N. K., van der Graaf, W. T. A., & van de Poll-Franse, L. V. (2019) · The Oncologist · doi:10.1634/theoncologist.2019-0348 · Cited by 251 · see citing works
Kumar, S., Kroon, J., & Lalloo, R. (2014) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-12-41 · Cited by 245 · see citing works
“The Wilson and Cleary model of health-related QoL demonstrates that individual perceptions of QoL are influenced by several individual, environmental characteristics and also non-medical factors [16].”
BackgroundRose, M., Fliege, H., Hildebrandt, M., Schirop, T., & Klapp, B. F. (2002) · Diabetes Care · doi:10.2337/diacare.25.1.35 · Cited by 245 · see citing works
Satisfaction with Medication: An Overview of Conceptual, Methodologic, and Regulatory Issues
Shikiar, R., & Rentz, A. M. (2004) · Value in Health · doi:10.1111/j.1524-4733.2004.72252.x · Cited by 245 · see citing works
What Information Do Consumers Want and Need?
Edgman‐Levitan, S., & Cleary, P. D. (1996) · Health Affairs · doi:10.1377/hlthaff.15.4.42 · Cited by 243 · see citing works
Systematic review of outcomes used to evaluate enhanced recovery after surgery
Neville, A., Lee, L., Antonescu, I., Mayo, N., Vassiliou, M., Fried, G., & Feldman, L. (2014) · British Journal of Surgery · doi:10.1002/bjs.9324 · Cited by 218 · see citing works
Greenhalgh, J., Dalkin, S. M., Gooding, K., Gibbons, E. J., Wright, J. M., Meads, D. M., Black, N. A., Valderas, J. M., & Pawson, R. (2017) · Health Services and Delivery Research · doi:10.3310/hsdr05020 · Cited by 238 · see citing works
“Attempts to address this conundrum included the development of models to show the pathway through which changes to clinical variables impacted on symptoms, which in turn impacted on a patient’s functional status, general health perceptions and, ultimately, overall quality of life.(250)”
MethodReliability and validity of two self-report measures of impairment and disability for MS
Schwartz, C. E., Vollmer, T. L., & Lee, H. (1999) · Neurology · doi:10.1212/wnl.52.1.63 · Cited by 234 · see citing works
Meterko, M. M., Wright, S., Lin, H., Lowy, E., & Cleary, P. D. (2010) · Health Services Research · doi:10.1111/j.1475-6773.2010.01138.x · Cited by 234 · see citing works
Outcomes of Percutaneous Endoscopic Gastrostomy Among Older Adults in a Community Setting
Callahan, C. M., Haag, K. M., Weinberger, M., Tierney, W. M., Buchanan, N. N., Stump, T. E., & Nisi, R. (2000) · Journal of the American Geriatrics Society · doi:10.1111/j.1532-5415.2000.tb04779.x · Cited by 225 · see citing works
Health-related Quality of Life after Acute Lung Injury
Weinert, C., Gross, C. R., KANGAS, J. R., BURY, C. L., & Marinelli, W. A. (1997) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/ajrccm.156.4.9611047 · Cited by 221 · see citing works
“Our definition of health-related QOL posits a core set of causally linked dimensions of health starting with biologic/physiologic variables and proceeding through symptoms, mental, physical, and social function, health perception, and quality of life ( 6 ).”
BackgroundPatient-Reported Outcomes: Conceptual Issues
Rothman, M. L., Beltran, P., Cappelleri, J. C., Lipscomb, J., & Teschendorf, B. (2007) · Value in Health · doi:10.1111/j.1524-4733.2007.00269.x · Cited by 224 · see citing works
Rooks, D. S. (2007) · Archives of Internal Medicine · doi:10.1001/archinte.167.20.2192 · Cited by 219 · see citing works
Assessing the impact of cancer on work outcomes
Steiner, J. F., Cavender, T. A., Main, D. S., et al. (2004) · Cancer · doi:10.1002/cncr.20564 · Cited by 216 · see citing works
“Model adapted from Wilson and Cleary, 1995.(36) 1708 CANCER October 15, 2004 / Volume 101 / Number 8”
BackgroundMethodPatient-Reported Measures of Health: The Veterans Health Study
Kazis, L. E., Miller, D. R., Skinner, K. M., Lee, A., Ren, X. S., Clark, J. A., Rogers, W. H., Spiro, A., Selim, A., Linzer, M., et al. (2004) · Journal of Ambulatory Care Management · doi:10.1097/00004479-200401000-00012 · Cited by 207 · see citing works
“Clinical measures have on occasion been uncorrelated with patient-derived measures of health, including functional status and well-being (Wilson & Cleary, 1995).”
Quality of life in essential tremor questionnaire (QUEST): development and initial validation
Tröster, A. I., Pahwa, R., Fields, J. A., Tanner, C. M., & Lyons, K. E. (2005) · Parkinsonism & Related Disorders · doi:10.1016/j.parkreldis.2005.05.009 · Cited by 217 · see citing works
- Authors
- Wilson, I. B.
- Corresponding author
- Wilson, Ira B.
- ORCID
- Wilson, Ira B.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 1995-01-04
- Volume
- 273
- Issue
- 1
- Pages
- 59
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W4292024189
- Cited by
- 3,027
- References
- 0
- Citations by year
- 2026: 151 · 2025: 168 · 2024: 134 · 2023: 141 · 2022: 176 · 2021: 183 · 2020: 197 · 2019: 137 · 2018: 138 · 2017: 130 · 2016: 145 · 2015: 131 · 2014: 128 · 2013: 123 · 2012: 106
- FWCI
- 96.54
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- Funders
- Agency for Healthcare Research and Quality (1-R01-HS06239)
- Topics
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Keywords
- health-related quality of life, clinical factors, patient-reported outcomes, outcome measures, quality of care, effectiveness research, health assessment
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