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Demonstrating respect and acceptable consent strategies: what matters to patients in patient-centered outcomes research (PCOR)?
Investigator (PI): Kass, Nancy
Past Investigator: Faden, Ruth
Performing Organization (PO): (Current): Johns Hopkins University, Berman Institute of Bioethics / (410) 614-5550
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2014
Final Year: 2019
Record Source/Award ID: PCORI/ME-1310-07763
Funding: Total Award Amount: $1,688,562
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Background: Patient-centered outcomes research (PCOR) can improve the quality of medical care. Yet informed consent approaches developed for more experimental, riskier research may not be a good fit for PCOR, while also being harder to do efficiently. This study will seek patients' views about the acceptability of four disclosure/consent approaches for PCOR, including shorter ways of telling patients about medical research. We also will see what patients think about additional ways of demonstrating respect to them in PCOR, beyond consent, namely, engagement, transparency, and accountability (ETA). Objectives: The study objectives are (1) to assess patients' views about the importance of patient engagement (in ethics oversight of PCOR and in determining which types of disclosure/consent practices are OK for which studies), transparency (about which PCOR studies are happening and how they affect patients' medical care), and accountability (about how health care changes after a study is done) in showing respect to patients in PCOR; (2) to assess whether patients have more favorable attitudes towards shorter disclosure/consent approaches when studies have little impact on what matters to patients, including how their care is delivered and when all treatments work well and are used regularly; (3) to see if patients like shorter, better disclosure/consent approaches when ETA practices are in place; (4) to see if patients like shorter, better disclosure/consent approaches most when ETA practices are in place and when studies don't change their care much, and when all treatments work well and are used regularly; (5) to see if patients' views on the above questions differ by income, ethnicity, gender, education, age, research experience or health status, or the type of health system where they get care; and (6) to make recommendations about next steps for actionable policies and practices. Methods: We will hold 4 focus groups and survey 800 patients from Johns Hopkins Healthcare (JHHC) and Geisinger Clinic (GC). Focus groups will be held to make sure study materials are clear and cover topics important to patients. Patients will get different (randomly varied) versions of the survey so they each get one of four case examples of a PCOR study. Case studies will compare two treatments that are 1) more or 2) less similar to each other in ways that might matter to patients and 3) will or 4) won't also include engagement, transparency, and accountability. Patients will be asked what they think about four different disclosure/consent options for the study. Patients also will be asked what they think about how risky and respectful the case is compared to usual care, trust, and background information. Patient outcomes: This study will show whether patients think shorter disclosure/consent approaches are OK, or under what conditions they think they are OK, related either to the type of study, or whether other ways of showing them respect are in place.
MeSH Terms:
  • Attitude
  • Female
  • Focus Groups
  • Health Status
  • Humans
  • Informed Consent
  • Male
  • Maryland
  • * Outcome Assessment, Health Care
  • Patient Participation
  • Patient-Centered Care /*organization & administration
  • Reproducibility of Results
  • Research Design
  • Risk
  • * Truth Disclosure
Country: United States
State: Maryland
Zip Code: 21205
UI: 20152282
Project Status: Completed
Record History: ('2019: Project extended to 2019. ',) ('2017: Project extended to 2018 and PI changed.',)