Assessing the value of patient-generated data to comparative effectiveness research

Health Affairs

Volumn 33, Issue 7, 2014, Pages 1220-1228

  Howie, Lynn ^a   Hirsch, Bradford ^b   Locklear, Tracie ^b   Abernethy, Amy P ^b,c  

^a DUKE UNIVERSITY   (United States)

^b DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^c DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; COMPARATIVE EFFECTIVENESS; DATA ANALYSIS; HEALTH CARE DELIVERY; HEALTH SERVICE; MEDICAL RESEARCH; PATIENT CODING; PATIENT INFORMATION; TREATMENT OUTCOME; ELECTRONIC HEALTH RECORD; EVIDENCE BASED MEDICINE; HEALTH CARE QUALITY; HUMAN; INFORMATION PROCESSING; MEDICAL RECORD; PROCEDURES; TRENDS;

COMPARATIVE EFFECTIVENESS RESEARCH; DATASETS AS TOPIC; DELIVERY OF HEALTH CARE; ELECTRONIC HEALTH RECORDS; EVIDENCE-BASED MEDICINE; HEALTH RECORDS, PERSONAL; HUMANS; QUALITY OF HEALTH CARE;

EID: 84905995767     PISSN: 02782715     EISSN: 15445208     Source Type: Journal    
DOI: 10.1377/hlthaff.2014.0225     Document Type: Article

References (31)

1. Institute of Medicine. Initial national priorities for comparative effectiveness research. Washington (DC): National Academies Press; 2009.
2. Luce BR, Kramer JM, Goodman SN, Connor JT, Tunis S,Whicher D, et al. Rethinking randomized clinical trials for comparative effectiveness research: the need for transformational change. Ann Intern Med. 2009;151(3):206-9.
3. Dreyer NA, Tunis SR, Berger M, Ollendorf D, Mattox P, Gliklich R. Why observational studies should be among the tools used in comparative effectiveness research. Health Aff (Millwood). 2010;29(10):1818-25.
4. Harrison MR, Hirsch BR, George DJ, Walker MS, Chen C, Korytowsky B, et al. Real-world outcomes in metastatic renal cell carcinoma: insights from a joint community-academic registry. J Oncol Pract. 2014;10(2): e63-72.
5. Mandl KD, Edge S, Malone C, Marsolo K, Natter MD. Next-generation registries: fusion of data for care, and research. AMIA Jt Summits Transl Sci Proc. 2013;2013:164-7.
6. Miriovsky BJ, Shulman LN, Abernethy AP. Importance of health information technology, electronic health records, and continuously aggregating data to comparative effectiveness research and learning health care. J Clin Oncol. 2012;30 (34):4243-8.
7. Sittig DF, Hazlehurst BL, Brown J, Murphy S, Rosenman M, Tarczy-Hornoch P, et al. A survey of informatics platforms that enable distributed comparative effectiveness research using multi-institutional heterogenous clinical data. Med Care. 2012;50(Suppl):S49-59.
8. Basch E. Toward patient-centered drug development in oncology. N Engl J Med. 2013;369(5):397-400.
9. Cella D, Webster K. Linking outcomes management to quality-of-life measurement. Oncology (Williston Park). 1997;11(11A):232-5.
10. Coates A, Porzsolt F, Osoba D. Quality of life in oncology practice: prognostic value of EORTC QLQ-C30 scores in patients with advanced malignancy. Eur J Cancer. 1997; 33(7):1025-30.
11. Dancey J, Zee B, Osoba D,Whitehead M, Lu F, Kaizer L, et al. Quality of life scores: an independent prognostic variable in a general population of cancer patients receiving chemotherapy. The National Cancer Institute of Canada Clinical Trials Group. Qual Life Res. 1997;6(2):151-8.
12. PROMIS [home page on the Internet]. Washington (DC): Department of Health and Human Services; [cited 2014 Jun 5]. Available from: http://www.nihpromis.org
13. Shapiro MF, Johnston D, Wald J, Mon D. Patient-generated health data [Internet]. Research Triangle Park (NC): RTI International; 2012 Apr [cited 2014 May 30]. Available from: http://www.rti.org/pubs/ patientgeneratedhealthdata.pdf
14. Food and Drug Administration. Guidance for industry: patientreported outcome measures: use in medical product development to support labeling claims [Internet]. Silver Spring (MD): FDA; 2009 Dec [cited 2014 Jun 5]. Available from: http://www.fda.gov/downloads/ Drugs/Guidances/UCM193282.pdf
15. To access the Appendix, click on the Appendix link in the box to the right of the article online
16. Kost RG, Lee LM,Yessis J,Wesley RA, Henderson DK, Coller BS. Assessing participant-centered outcomes to improve clinical research. N Engl J Med. 2013;369(23):2179-81.
17. Basch E, Snyder C, McNiff K, Brown R, Maddux S, Smith ML, et al. Patient-reported outcome performance measures in oncology. J Oncol Pract. 2014;10(3):209-11.
18. Smith SK, Herndon JE, Lyerly HK, Coan A, Wheeler JL, Staley T, et al. Correlates of quality of life-related outcomes in breast cancer patients participating in the Pathfinders pilot study. Psychooncology. 2011;20(5): 559-64.
19. Hirsch BR, Abernethy AP. Incorporating the patient's voice in the continuum of care. J Natl Compr Canc Netw. 2013;11(1):116-8.
20. Abernethy AP, Ahmad A, Zafar SY, Wheeler JL, Reese JB, Lyerly HK. Electronic patient-reported data capture as a foundation of rapid learning cancer care. Med Care. 2010;48(6 Suppl):S32-8.
21. Abernethy AP,Wheeler JL, Zafar SY. Management of gastrointestinal symptoms in advanced cancer patients: the rapid learning cancer clinic model. Curr Opin Support Palliat Care. 2010;4(1):36-45.
22. Silow-Carroll S, Edwards JN, Rodin D. Using electronic health records to improve quality and efficiency: the experiences of leading hospitals. Issue Brief (Commonw Fund). 2012; 17:1-40.
23. Abernethy AP. Patient reported outcomes data in action-real time information for clinical care and research. Keynote address at: 34th annual meeting of the Society of Behavioral Medicine; 2013 Mar 22; San Francisco, CA.
24. Bell ML, Fairclough DL. Practical and statistical issues in missing data for longitudinal patient reported outcomes. Stat Methods Med Res. 2013 Feb 19. [Epub ahead of print].
25. HealthIT.gov. EHR incentives and certifications: meaningful use definition and objectives [Internet]. Washington (DC): Department of Health and Human Services; [cited 2014 Jun 5]. Available from: http:// www.healthit.gov/providersprofessionals/ meaningful-usedefinition-objectives
26. National Institutes of Health. NIH Collaboratory [home page on the Internet]. Bethesda (MD): NIH; [cited 2014 May 30]. Available from: https://www.nihcollaboratory.org/ Pages/default.aspx
27. Richesson RL, Hammond WE, Nahm M, Wixted D, Simon GE, Robinson JG, et al. Electronic health records based phenotyping in next-generation clinical trials: a perspective from the NIH Health Care Systems Collaboratory. J Am Med Inform Assoc. 2013;20(e2):e226-31.
28. DeBar LL, Kindler L, Keefe FJ, Green CA, Smith DH, Deyo RA, et al. A primary care-based interdisciplinary team approach to the treatment of chronic pain utilizing a pragmatic clinical trials framework. Transl Behav Med. 2012;2(4):523-30.
29. DeBar L, McMullen C, Bauck A (Kaiser Permanente Northwest, Hillsboro, OR). Health Care Systems Research Collaboratory grand rounds: collaborative care for chronic pain in primary care: systematizing our approach for ensuring PRO data quality and stakeholder engagement [Internet]. Bethesda (MD): NIH; 2013 Jan 18 [cited 2014 Jun 5]. Available from: https://www.nihcollaboratory.org/ Pages/Grand-Rounds-01-18-13.aspx
30. Patient Centered Outcomes Research Institute. Clinical Data and Patient-Powered Research Networks- awarded projects [Internet]. Washington (DC): PCORI; [updated 2014 Mar 24; cited 2014 May 30]. Available from: http://www.pcori.org/ funding-opportunities/landing/ clinical-data-and-patient-poweredresearch-networks-awardedprojects/
31. Sledge GW Jr, Miller RS, Hauser R. CancerLinQ and the future of cancer care. Am Soc Clin Oncol Educ Book. 2013;430-4.