Patient-Centered Outcome Assessment May Lead to Different Conclusions and Different Treatment Decisions | Page 2
Published Online: June 20, 2014
Robert M. Kaplan, PhD, chief science officer, Agency for Healthcare Research and Quality
Many of the controversies in contemporary medicine are related to the differences between the PCOR perspective and the emphasis on more traditional surrogate markers. For example, a current debate centers on the aggressive management of high blood pressure in the elderly. Even though aggressive management of blood pressure in older adults may reduce the chances of stroke, there is some concern that it will result in an increase in heart attacks, diminished cognitive functioning, and an increase in falls.17 Laser focus on measures of blood pressure may miss the bigger, and perhaps more important, quality-of-life picture that is most important to patients. There are also examples of studies that fail to achieve changes in biological surrogate markers, but do find changes in important patient-reported outcomes. For example, rehabilitation for patients with chronic obstructive pulmonary disease rarely results in changes in measures of lung function. Yet, these studies consistently observe improvements in functional status and quality of life.18
Differences in conclusions between the PCOR perspective and traditional investigation are not rare. In large clinical trials, for example, it is common to observe changes in biological process variables without finding differences in life expectancy or health-related quality of life.19 We expect continuing methodological discussions about the value of patient-reported experience. PCOR is a relatively new area of research investigation, and we need to learn more about how to reliably assess patient experience and how to integrate the patient perspective into the clinical decision- making process. To date, the best evidence from PCOR is rarely absorbed into clinical care.20 But AHRQ and PCORI are committed to a rigorous research agenda on these topics. Advancing research methodologies, including new approaches to clinical research, should inform this discussion by centering medical decision- making on the preferences of the most important stakeholder— the patient.
Author Affiliation: Robert M. Kaplan, PhD, is chief science officer at the Agency for Healthcare Research and Quality, Rockville, MD.
Address Correspondence to: Associate editorial director Nicole Beagin: email@example.com; 609-716-7777 ext. 131.
1. Kaplan RM, Ries AL. Quality of life: concept and definition. COPD. 2007;4(3):263- 271.
2. Smith WB, Safer MA. Effects of present pain level on recall of chronic pain and medication use. Pain. 1993;55(3):355-361.
3. Brown DS, Jia H, Zack MM, Thompson WW, Haddix AC, Kaplan RM. Using health-related quality of life and quality-adjusted life expectancy for effective public health surveillance and prevention. Expert Rev Pharmacoecon Outcomes Res. 2013;13(4):425-427.
4. Cherepanov D, Palta M, Fryback DG, Robert SA, Hays RD, Kaplan RM. Gender differences in multiple underlying dimensions of health-related quality of life are associated with sociodemographic and socioeconomic status. Med Care. 2011;49(11):1021-1030.
5. Kaplan RM. Diseases, Diagnoses, and Dollars. New York, NY: Springer; 2009.
6. Yost KJ, Thompson CA, Eton DT, et al. The Functional Assessment of Cancer Therapy - General (FACT-G) is valid for monitoring quality of life in patients with non-Hodgkin lymphoma. Leuk Lymphoma. 2013;54(2):290-297.
7. Speight J, Sinclair AJ, Browne JL, Woodcock A, Bradley C. Assessing the impact of diabetes on the quality of life of older adults living in a care home: validation of the ADDQoL Senior. Diabet Med. 2013;30(1):74-80.
8. Fteropoulli T, Stygall J, Cullen S, Deanfield J, Newman SP. Quality of life of adult congenital heart disease patients: a systematic review of the literature. Cardiol Young. 2013;23(4):473-485.
9. Ellwood PM. Shattuck lecture--outcomes management: a technology of patient experience. New Engl J Med. 1988;318(23):1549-1556.
10. Kaplan RM. Two pathways to prevention. Am Psychol. 2000;55(4):382-396.
11. Kaplan RM. Quality of life: an outcomes perspective. Arch Phys Med Rehabil. 2002;83(12, suppl 2):S44-S50.
12. Kaplan RM. Behavior as the central outcome in health care. Am Psychol. 1990; 45(11):1211-1220.
13. Kaplan RM. The Ziggy theorem: toward an outcomes-focused health psychology. Health Psychol. 1994;13(6):451-460.
14. Gøtzsche PC, Jorgensen KJ. Screening for breast cancer with mammography. Cochrane Database Syst Rev. 2013;6:CD001877.
15. Miller AB, Wall C, Baines CJ, Sun P, To T, Narod SA. Twenty-five-year follow-up for breast cancer incidence and mortality of the Canadian National Breast Screening Study: randomised screening trial. BMJ. 2014;348:g366.
16. Kaplan RM. Health outcome models for policy analysis. Health Psychol. 1989;8(6): 723-735.
17. Mancia G, Grassi G. Aggressive blood pressure lowering is dangerous: the J-curve: pro side of the arguement. Hypertension. 2014;63(1):29-36.
18. Ries AL, Kaplan RM, Limberg TM, Prewitt LM. Effects of pulmonary rehabilitation on physiologic and psychosocial outcomes in patients with chronic obstructive pulmonary disease. Ann Intern Med. 1995;122(11):823-832.
19. Gerstein HC, Miller ME, et al.; Action to Control Cardiovascular Risk in Diabetes Study G. Effects of intensive glucose lowering in type 2 diabetes. New Engl J Med. 2008;358(24):2545-2559.
20. Han PK, Kobrin S, Breen N, et al. National evidence on the use of shared decision making in prostate-specific antigen screening. Ann Fam Med. 2013;11(4):306-314.