Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Quality of Life Research
Published in: Quality of Life Research 1/2018

Open Access 01-01-2018 | Special Section: Measuring What Matters (by invitation only)

Methods and impact of engagement in research, from theory to practice and back again: early findings from the Patient-Centered Outcomes Research Institute

Authors: Laura Forsythe, Andrea Heckert, Mary Kay Margolis, Suzanne Schrandt, Lori Frank

Published in: Quality of Life Research | Issue 1/2018

Login to get access

Abstract

Purpose

Since 2012, PCORI has been funding patient-centered comparative effectiveness research with a requirement for engaging patients and other stakeholders in the research, a requirement that is unique among the US funders of clinical research. This paper presents PCORI’s evaluation framework for assessing the short- and long-term impacts of engagement; describes engagement in PCORI projects (types of stakeholders engaged, when in the research process they are engaged and how they are engaged, contributions of their engagement); and identifies the effects of engagement on study design, processes, and outcomes selection, as reported by both PCORI-funded investigators and patient and other stakeholder research partners.

Methods

Detailed quantitative and qualitative information collected annually from investigators and their partners was analyzed via descriptive statistics and cross-sectional qualitative content and thematic analysis, and compared against the outcomes expected from the evaluation framework and its underlying conceptual model.

Results

The data support the role of engaged research partners in refinements to the research questions, selection of interventions to compare, choice of study outcomes and how they are measured, contributions to strategies for recruitment, and ensuring studies are patient-centered.

Conclusions

The evaluation framework and the underlying conceptual model are supported by results to date. PCORI will continue to assess the effects of engagement as the funded projects progress toward completion, dissemination, and uptake into clinical decision making.
Appendix
Available only for authorised users
Literature
1.
Reeve, B. B., Wyrwich, K. W., Wu, A. W., Velikova, G., Terwee, C. B., Snyder, C. F., et al. (2013). ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Quality of Life Research, 22(8), 1889–1905.CrossRefPubMed
2.
Kirwan, J. R., & Hewlett, S. (2007). Patient perspective: Reasons and methods for measuring fatigue in rheumatoid arthritis. Journal of Rheumatology, 34(5), 1171–1173.PubMed
3.
Food and Drug Administration (FDA). (2009). Guidance for industry on patient-reported outcome measures: Use in medical product development to support labeling claims, federal register (Vol. 74, pp. 65132–65133). Washington, DC: U.S. Department of Health and Human Services.
4.
Charlton, J. I. (1998). Nothing about us without us: Disability oppression and empowerment. Berkeley: University of California Press.CrossRef
5.
Viswanathan, M., Ammerman, A., Eng, E., Garlehner, G., Lohr, K. N., Griffith, D., Rhodes, S., Samuel-Hodge, C., Maty, S., Lux, L., Webb, L., Sutton, S. F., Swinson, T., Jackman, A., & Whitener, L. (2004). Community-based participatory research: Assessing the evidence. Evidence Report Technology Assessment (Summ)(99), 1–8.
6.
Jones, M. M., Kamenetzky, A., Manville, C., Ghiga, I., MacLure, C., Harte, E., et al. (2016). The National Institute for Health Research at 10 Years. Arlington, VA: RAND Corporation.
7.
8.
Staley, K. (2009). Exploring impact: Public involvement in NHS, public health and social care research. Eastleigh: INVOLVE.
9.
Ring, L. (2016, July). EMA review and qualification process. Paper presented at the ISOQOL Measuring What Matters Symposium, Washington, DC.
10.
11.
Rich, E. C. (2016). From concept to policy: 10 years after the call for a US center for comparative effectiveness information. Journal of Comparative Effectiveness Research, 6, 9–11.CrossRefPubMed
12.
Postmus, D., Mavris, M., Hillege, H. L., Salmonson, T., Ryll, B., Plate, A., et al. (2016). Incorporating patient preferences into drug development and regulatory decision making: Results from a quantitative pilot study with cancer patients, carers, and regulators. Clinical Pharmacology and Therapeutics, 99(5), 548–554.CrossRefPubMed
13.
14.
National Institutes for Health Research. (2016). Going the Extra Mile. Paper presented at the Patient and Public Involvement NIHR Impact Workshop.
15.
Dudley, L., Gamble, C., Preston, J., Buck, D., The EPIC Patient Advisory Group, Hanley, B., et al. (2015). What difference does patient and public involvement make and what are its pathways to impact? Qualitative study of patients and researchers from a cohort of randomised clinical trials. PLoS ONE, 10(6), e0128817.CrossRefPubMedPubMedCentral
16.
Frank, L., Forsythe, L., Ellis, L., Schrandt, S., Sheridan, S., Gerson, J., et al. (2015). Conceptual and practical foundations of patient engagement in research at the patient-centered outcomes research institute. Quality of Life Research, 24(5), 1033–1041.CrossRefPubMedPubMedCentral
17.
18.
Forsythe, L. P., Frank, L., Walker, K. O., Anise, A., Wegener, N., Weisman, H., et al. (2015). Patient and clinician views on comparative effectiveness research and engagement in research. Journal of Comparative Effectiveness Research, 4(1), 11–25.CrossRefPubMed
19.
Vaismoradi, M., Turunen, H., & Bondas, T. (2013). Content analysis and thematic analysis: Implications for conducting a qualitative descriptive study. Nursing & Health Sciences, 15(3), 398–405.CrossRef
20.
Guest, G., MacQueen, Kathleen M., & Emily, E. (2012). Applied thematic analysis. Thousand Oaks, California: Sage Publications Inc.CrossRef
21.
Sandelowski, M. (2001). Real qualitative researchers do not count: the use of numbers in qualitative research. Research in Nursing & Health, 24(3), 230–240.CrossRef
22.
Concannon, T. W., Fuster, M., Saunders, T., Patel, K., Wong, J. B., Leslie, L. K., et al. (2014). A Systematic review of stakeholder engagement in comparative effectiveness and patient-centered outcomes research. Journal of General Internal Medicine, 29(12), 1692–1701.CrossRefPubMedPubMedCentral
23.
Moher, D., Glasziou, P., Chalmers, I., Nasser, M., Bossuyt, P. M., Korevaar, D. A., et al. (2016). Increasing value and reducing waste in biomedical research: who’s listening? Lancet, 387(10027), 1573–1586.CrossRefPubMed
24.
Kasenda, B., von Elm, E., You, J., Blumle, A., Tomonaga, Y., Saccilotto, R., et al. (2014). Prevalence, characteristics, and publication of discontinued randomized trials. JAMA, 311(10), 1045–1051.CrossRefPubMed
25.
Mercieca-Bebber, R., Palmer, M. J., Brundage, M., Calvert, M., Stockler, M. R., & King, M. T. (2016). Design, implementation and reporting strategies to reduce the instance and impact of missing patient-reported outcome data: A systematic review. Quality of Life Research, 24(6), 81.
26.
Brett, J., Staniszewska, S., Mockford, C., Herron-Marx, S., Hughes, J., Tysall, C., et al. (2014). Mapping the impact of patient and public involvement on health and social care research: A systematic review. Health Expectations, 17(5), 637–650.CrossRefPubMed
27.
Domecq, J. P., Prutsky, G., Elraiyah, T., Wang, Z., Nabhan, M., Shippee, N., et al. (2014). Patient engagement in research: A systematic review. BMC Health Services Research, 14, 89.CrossRefPubMedPubMedCentral
28.
Forsythe, L. P., Ellis, L. E., Edmundson, L., Sabharwal, R., Rein, A., Konopka, K., et al. (2016). Patient and stakeholder engagement in the PCORI pilot projects: Description and lessons learned. Journal of General Internal Medicine, 31(1), 13–21.CrossRefPubMed
29.
Forsythe, L. P., Szydlowski, V., Murad, M. H., Ip, S., Wang, Z., Elraiyah, T. A., et al. (2014). A systematic review of approaches for engaging patients for research on rare diseases. Journal of General Internal Medicine, 29(Suppl 3), S788–S800.CrossRefPubMed
30.
Shippee, N. D., Domecq Garces, J. P., Prutsky Lopez, G. J., Wang, Z., Elraiyah, T. A., Nabhan, M., et al. (2015). Patient and service user engagement in research: a systematic review and synthesized framework. Health Expectations, 18(5), 1151–1166.CrossRefPubMed
31.
Forsythe, L., Anyanwu, C., Schneider, M., Brentzel, F., Kohler, P., Ritok, M., et al. (2016). Patient and stakeholder engagement in research: Identifying challenges and developing solutions. National Harbor, Maryland: PCORI Second Annual Meeting.
Metadata
Title
Methods and impact of engagement in research, from theory to practice and back again: early findings from the Patient-Centered Outcomes Research Institute
Authors
Laura Forsythe
Andrea Heckert
Mary Kay Margolis
Suzanne Schrandt
Lori Frank
Publication date
01-01-2018
Publisher
Springer International Publishing
Published in
Quality of Life Research / Issue 1/2018
Print ISSN: 0962-9343
Electronic ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-017-1581-x

Other articles of this Issue 1/2018

Quality of Life Research 1/2018 Go to the issue

OriginalPaper

Prevalence of patient-reported gastrointestinal symptoms and agreement with clinician toxicity assessments in radiation therapy for anal cancer

Special Section: Measuring What Matters (by invitation only)

Beyond study participants: a framework for engaging patients in the selection or development of clinical outcome assessments for evaluating the benefits of treatment in medical product development

OriginalPaper

Assessing responsiveness over time of the PROMIS® pediatric symptom and function measures in cancer, nephrotic syndrome, and sickle cell disease

OriginalPaper

How is weight stigma related to children’s health-related quality of life? A model comparison approach

OriginalPaper

Combat exposure, emotional and physical role limitations, and substance use among male United States Army Reserve and National Guard soldiers

Special Section: Measuring What Matters (by invitation only)

Prioritizing research topics: a comparison of crowdsourcing and patient registry