Introduction & Agenda

• Letter to Participants from Drs. Lynne Stevenson and Ty Gluckman
• The Integration of Patient-Reported Outcomes into Cardiovascular Care Forum Agenda

PRESENTATIONS
History, Validation and Future of PROs

• Presentation 1: History and Current State of PROs John Spertus, MD, MPH, FACC
• Presentation 2: Future State of PROs Susan Yount

Session 1: PROs are Central to Optimal Care Delivery

• Presentation 1: Incorporating Patients Perspective, Our North Star Bray Patrick-Lake, MFS
• Presentation 2: Optimal Use of Health, Quality of Life, and Functional Status PROs Nicole Lohr, MD, PhD, FACC

Session 2: Registries, Research and Regulators

• Presentation 1: Where do PROs Belong in the Guidelines? An Important Step to Accountability Lynne Warner Stevenson, MD, FACC
• Presentation 2: NCDR's Roadmap for Incorporating PROs into Registries: Moving Beyond the Hospital Walls Frederick A. Masoudi, MD, MSPH, FACC
• Presentation 3: Research Related to PROs: Another Key Step to Accountability Steven M. Bradley, MD, MPH, FACC
• Presentation 4: PROs and Approvals for Drugs and Devices: Perspectives from the FDA Bram D. Zuckerman, MD, FACC

Session 3. Boots on the Ground Implementation

• Presentation 1: Getting Started: Keys to Successful Implementation Ty Gluckman, MD, FACC
• Presentation 2: Surveying the Technology Landscape: What's Here, What's Coming John Rumsfeld, MD, PhD, FACC
• Presentation 3: Operationalizing PROs within the Health System, Hospital, and Practice: Where to Begin Jacob A. Lippa, MPH

Patient-Reported Outcomes – General

1. Across US hospitals black patients report comparable or better experiences than white patients. Figueroa JF et al. Health Affairs 2016; 8: 1391-1398
2. Associations between internet-based patient ratings and conventional surveys of patient experience in the English NHS: an observational study. Greaves F et al. BMJ Qual Saf 2012; 21: 600-605
3. Better physician ratings from discussing PROs with patients. Freel JF et al. NEJM Catalyst 2018.
4. Hospital cv outcome measures in federal pay for reporting and pay for performance programs: a brief overview of current efforts. Spivack et al. Circ
5. How does satisfaction with the health-care system relate to patient experience? Bleich S et al. Bull World Health Organ 2009; 87: 271-78
6. Lecture 4: Satisfaction, Responsiveness and Patient Experience (PowerPoint)
7. Measuring patient experience. De Silva D. The Health Foundation 2013;18: 1-34
8. Patient reported outcomes – are they living up to their potential? Baumhauer JF. NEJM 2017;377: 6-8
9. Patients' perception of hospital care in the United States. Jha AK et al. NEJM 2008; 359: 1921-1931
10. Relationship between hospital performance on a patient satisfaction survey and surgical quality. Sacks GD. JAMA Surg. 2015; 9: 858-864
11. Restaurant chains have managed to combine quality control, cost control, and innovation. Can health care? Gawande A. Annals of Health Care 2012
12. The cost of satisfaction. Fenton J et al. American Medical Association 2012;5: 405-11
13. The patient experience and health outcomes. Manary MP et al. NEJM 2013;368(3): 201-03
14. Understanding satisfaction, responsiveness and experience with the health system. Busse R. Health System Performance Comparison 2013; 9: 255-80
15. Value in cardiovascular care. Bradley S et al. Heart 2017;103: 1238-1243
16. What can Yelp teach us about measuring hospital quality? Ranard BL et al. Health Aff (Millwood) 2016; 4: 697-705

Disease Specific Patient-Reported Outcome Resources

1. The routine clinical capture of patient-reported outcomes – how competition on value will lead to change. Bradley SM. Circ Cardiovasc Qual Outcomes 2014;7: 635-36
2. Utility of patient reported outcome instruments in heart failure. Kelkar AA et al. JACC Heart Failure 2016: 4: 165-75
3. Variable contribution of heart failure to quality of life in ambulatory heart failure. Joyce E et al. JACC Heart Failure 2016; 4: 184-93

Hospitals, Practices & Patient-Reported Outcomes

1. A systematic review of the impact of routine collection of patient reported outcome measures on patients, providers and health organisations in an oncologic setting. Chen J et al. BMC Health Serv Res 2013;13: 211
2. Implementing electronic patient-reported outcomes measurements: challenges and success factors. Nordan L et al. BMJ Qual Saf 2018;27(10): 852-856
3. Implementing patient-reported outcome measures. Wagle N. Partners HealthCare 2016

ONLINE-ONLY SUPPLEMENTAL READING

Patient-Reported Outcomes – General

1. Action brief: Patient-reported outcomes. Hopkins DH et al. Consumer-Purchaser Alliance
2. How hospitals are using patient-reported outcomes to improve care. Olson E et al. Harvard Business Review 2017
3. Making patients and doctors happier – the potential of patient-reported outcomes. Rotenstein LS et al. NEJM 2017;377: 1309-1312.
4. Patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs). Weldring T et al. Health Serv Insights 2013;6: 61-68
5. Patient-reported outcomes – harnessing patients' voices to improve clinical care. Basch E. NEJM 2017;376: 105-108
6. Patient reported outcome measures in practice. Nelson EC et al. BMJ 2015;350: g7818

Disease Specific Patient-Reported Outcome Resources

1. Association of patient-reported health status with long-term mortality after transcatheter aortic valve replacement: report from the STS/ACC TVT registry. Arnold SV et al. Circ Cardiovasc Interv 2015;8(12)
2. Ivabradine and Outcomes in Chronic Heart Failure (SHIFT): A Randomised Placebo-controlled Study (Lancet – Swedberg, et al., 2010).
3. Patient-reported outcomes for quality of life assessment in atrial fibrillation: a systematic review of measurement properties. Kotecha D et al. PLoS One 2016;11(11): e0165790
4. Patient-reported outcomes in chronic heart failure. Psotka MA et al. JACC Heart Failure 2016;4: 791-804
5. Quality-of-life outcomes after transcatheter aortic valve replacement in an unselected population – a report from the STS/ACC TVT registry. Arnold SV et al. JAMA Cardiol 2017;2(4): 409-416
6. Symptoms and quality of life after atrial fibrillation ablation – two different concepts. Dorian P et al. JACC Clinical Electrophysiology 2017;3(10): 1177-1179
7. The evolution of patient-reported outcomes in clinical trials and management of patients with coronary artery disease – 20 years with Seattle angina questionnaire. Spertus JA et al. JAMA Cardiol 2018

Registries & Patient-Reported Outcomes

1. Patient focused registries can improve health, care, and science. Nelson EC et al. BMJ 2016;354: i3319
2. Registries for evaluating patient outcomes: a user's guide. Third Edition. Gliklich RE et al. Agency for Healthcare Research and Quality 2014

Research & Patient-Reported Outcomes

1. Guidelines for inclusion of patient-reported outcomes in clinical trial protocols – the SPIRIT-PRO extension. Calvert M et al. JAMA 2018;319(5): 483-494
2. Guidelines for patient-reported outcomes in clinical trial protocols. Mehran R et al. JAMA 2018;319(5): 450-454
3. Outcome selection and role of patient reported outcomes in contemporary cardiovascular trials: systematic review. Rahimi K et al. BMJ 2010;341: c5707
4. The importance of patient-reported outcomes: a call for their comprehensive integration in cardiovascular clinical trials. Anker SD et al. Eur Heart J 2014;35(30): 2001-2009

FDA & Patient-Reported Outcomes

1. Clinical Outcome Assessment Qualification Program. FDA. US Food & Drug Administration 2018
2. Guidance for Industry – patient-reported outcome measures: use in medical product development to support labeling claims. FDA. US Dept of Health and Human Serv 2009; 1-43
3. Measuring how patients feel and function. Campbell M. US Food & Drug Administration 2017; 1-39
4. Value and use of patient-reported outcomes (PROs) in assessing effects of medical devices. FDA. CDRH Strategic Priorities 2016-2017

Hospitals, Practices & Patient-Reported Outcomes

1. Barriers to the use of patient-reported outcomes in clinical care. Spertus J. Circulation: Cardiovascular Quality and Outcomes 2014;7: 2-4
2. Framework and guidance for implementing patient-reported outcomes in clinical practice: evidence, challenges and opportunities. Porter I et al. J Comp Eff Res 2016;5(5): 507-519
3. How can health systems advance patient-reported outcome measurement? Lavallee DC et al. The Joint Commission Journal on Quality and Patient Safety 2018;44(8): 439-440
4. Incorporating patient-reported outcomes into health care to engage patients and enhance care. Lavallee DC et al. Health Affairs 2016;35(4)
5. Review of electronic patient-reported outcomes systems used in cancer clinical care. Jensen RE et al. Journal of Oncology Practice 2013;10(4): e215-e222
6. System-wide implementation of patient-reported outcomes in routine clinical care at a children's hospital. Gerhardt WE et al. The Joint Commission Journal on Quality and Patient Safety 2018;44(8): 441-453

Payers & Patient-Reported Outcomes

1. NCQA selects payer for patient-reported outcomes measures project. Heath S. Xtelligent 2018
2. Payer perspectives on patient-reported outcomes in health care decision making: oncology examples. Brogan AP et al. J Manag Care Spec Pharm 2017;23(2): 125-134
3. The role of patient-reported outcome measures in value-based payment reform. Squitieri L et al. Value Health 2017;20(6): 834-836