Patient-Reported Outcomes (PRO)
Comments on the draft handbook from from Bryan Luce, of United BioSource Corp.
Almac, a CRO, partners with with FACIT.org for electronic distribution of the FACITs Patient-Reported-Outcomes(PRO) and Quality of Life (QOL) assessments.
Brief patient-completed questionnaire that evaluates patients' experiences with a specific named physician and that physician's practice.
The Academy of Managed Care Pharmacy's (AMCP's) Quality Task Force has developed a guide for managed care organizations to use when implementing quality measures. (Source: urac-amcp.org, Winter 2011)
Presentation at ISPOR Europe, Nov. 2011, by Rob Thwaites, MA, Vice President, United BioSource Corporation, London, UK
Recent studies have shown that traditional clinical endpoints may not accurately reflect the patient experience with treatment. Often patients' experience of their disease and associated treatment differs from the perspective of their physicians.
With the growth in the use of health economic evaluation to inform healthcare resource allocation decisions, the challenges in applying standard methods to child health have become apparent. This paper presents and discusses existing and novel options for deriving utilities for paediatric health states for use in CUAs. (Source: AdisOnline.com, Ungar, Wendy J.)
An AMCP-sponsored review of the published literature concludes there is strong evidence to demonstrate the effectiveness of managed care pharmacy tools in achieving intended outcomes, such as increased utilization of preferred drugs, formulary compliance and decreased prescription drug spending.
Presentation at ISPOR Europe, Nov. 2011 by Elisa Cascade, MBA, Vice President, MediGuard.org, Rockville, MD, USA
Presentation at ISPOR Europe, Nov. 2011 by Paul Kind, MSc, MPhil, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK
These instruments provide vital measures of the effectiveness of treatment as well as the general well-being and physical and psychological state of the patient.
(Source: Outsourcing Pharma.com)
UBC provides analysis and summary of this guidance.
The government has unveiled its plans for a new outcomes framework to underpin the revamped National Health Service and establish accountability at a national level “in an open and transparent way”. The NHS Outcomes Framework will consist of a set of national outcome goals to help give an indication of the overall performance of the Service, as well as provide a mechanism by which the Health Secretary can hold the new independent NHS Commissioning Board to account for securing improved health outcomes. (Source: Pharma Times July 20, 2010)
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HHS' Agency for Healthcare Research and Quality (AHRQ) today announced the award of $473 million in grants and contracts to support projects that will help people make health care decisions based on the best evidence of effectiveness. The funding announced today covers all of AHRQ's allocation and $173 million administered for the HHS Secretary by AHRQ (Source:AHRQ).
The increasing importance of patient experience and the sustained interest in comparing people's satisfaction with the health system across different countries and time periods sug- gests the need to characterize the relationship between them.(Source: Sara N Bleich,a Emre O¨zaltinb & Christopher JL Murray)
While clinical care is frequently directed at making patients “feel better,” patients’ reports on their functioning and well-being (patient-reported outcomes [PROs]) are rarely collected in routine clinical practice. Integrating PROs in clinical practice has the potential to enhance patient-centered care. (Source: Information for Practice)
This 35-page analysis, based on the responses of 146 organizations to the Healthcare Intelligence Network July 2011 survey on Improving Patient Satisfaction and the Patient Experience, presents the all-new data in more than 45 easy-to-follow graphs and tables. market research found that most respondents are dissatisfied with their patient satisfaction scores . An instant PDF download is available for $117.
As use and understanding of health-related quality of life (HRQoL) and other patient-reported outcomes (PROs) have increased, researchers, clinicians and policy-makers have begun exploring different applications for these patient-centered outcome measures.
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Introduction to the NICE Reference Case, EQ-5D and the Alternatives TSDs 8 and 11, PPT by J. Brazier
Presentation at ISPOR Europe, Nov. 2011 by John Brazier, PhD, Professor, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK
invivodata announced for a limited time, complimentary PRO Gap Analysis service to help pharmaceutical research teams better understand what they should be doing differently in light of the FDA's final Guidance on PROs in clinical research. PRO Gap Analysis presents an opportunity for pharmaceutical and medical device researchers to speak with Senior PRO Scientists to assess what will be expected of them in their clinical research and PRO data from a regulatory standpoint.(Source:PR Web, March 24, 2010)
Presentation at ISPOR Europe, Nov. 2011, by Dominique Dubois, MD, FFPM, FBCPM, Managing Director, Outcomes Research, Patient Value Solutions, Huldenberg, Belgium
Provides a full list of instruments that have been approved by the Scientific Advisory Committee of the Medical Outcomes Trust. Click on the title of each instrument for a description and information about obtaining it.
Names of the 15 members to the Methodology Committee of the Patient-Centered Outcomes Research Institute (PCORI).(Source: GAO)
The NHWS database provides broad coverage of healthcare, with results that are generalizable to the population to deliver prevalence information in over 150 therapeutic conditions. NHWS includes information for patients who are diagnosed, undiagnosed yet symptomatic, untreated and for patients treated with a prescription or over-the-counter medication.
Invites the public to help craft the next generation of health care quality measures by participating in a public comment period about proposed changes to the next edition of NCQA's Healthcare Effectiveness Data and Information Set (HEDIS).”
The May 2011 Benchmarks in Patient Satisfaction e-survey by the Healthcare Intelligence Network captured efforts to improve patients’ and members’ experience and satisfaction with their care.
Suggest evidence-based quality measures and measure sets for possible inclusion in the National Quality Measures Clearinghouse™ (NQMC)
In March 2010, President Obama signed into law the Patient Protection and Affordable Care Act, broad health reform legislation that established the Patient-Centered Outcomes Research Institute (PCORI). Since that time, a number of important steps have been taken to implement PCORI, starting with the September 2010 appointment of a Board of Governors and continuing with the January 2011 announcement of the members of the Methodology Committee.(Source:National Pharmaceutical Council, February 2011)
Presentation delivered by Carolyn M. Clancy, M.D. at the 3rd National Comparative Effectiveness Summit, Oct. 12, 2011
After and long and "extraordinarily difficult" process, PCORI has finally come up with a definition of "patient-centered outcomes research". The definition had to encompass comparative effectiveness research, as well as how patients and providers communicate, studies of barrier, as well as what patients should do to improve those outcomes themselves.
MedicalTranslation blog post on PRO and FDA
PRO Consulting’s team of 15 scientists is at the forefront of PRO research, drawing from its experience in over 50 indications to provide input to clinical research teams making key decisions about PROs in support of clinical trial objectives. The webinar series will feature veteran scientists and regulatory experts presenting current topics related to the measurement and collection of PRO efficacy data in international clinical development. (Source: PRO Consulting)
Patient Reported Outcomes Measurement Information System (PROMIS),
funded by the National Institutes of Health (NIH), is a system of highly
reliable, valid, flexible, precise, and responsive assessment tools
that measure patient–reported health status.
Recommendations on Evidence Needed to Support Measurement Equivalence ISPOR EPRO Good Research Practices Task Force. Presentation at ISPOR Europe, Nov. 2011 by Stephen Joel Coons, PhD, Chad J. Gwaltney, PhD, Ron D. Hays, PhD, J. Jason Lundy, MS, Jeff A. Sloan, PhD, Dennis A. Revicki, PhD, William R. Lenderking, PhD, David Cella, PhD, Ethan Basch, MD, MSc on behalf of the ISPOR ePRO Task Force
We compared demographics and self-rated health of the PROMIS general Internet sample (N=11,796) and one of its subsamples (n=2,196) selected to approximate the joint distribution of demographics from the 2000 U.S. Census, with three national surveys and U.S. Census data. The comparisons were conducted using equivalence testing with weights created for PROMIS by raking.
Provides specifics concerning PCORI’s implementation, biographies of the new PCORI Board members, and a history of CER in the United States, as well as other resources.
In 2002, Dr. Arthur Stone published his ground-breaking work, “Patient Non-compliance with Paper Diaries” in the British Medical Journal (BMJ). This was the first publication to concretely demonstrate and quantify the unreliable and biased nature of paper diaries as a method of patient data collection in clinical trials. Here, Dr. Stone reflects on how the collection of Patient Reported Outcome (PRO) data has improved over the past ten years.
NQMC relies on the Institute of Medicine definition of quality of care as "the degree to which health care services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge." Quality measures, then, are mechanisms that enable the user to quantify the quality of a selected aspect of care by comparing it to an evidence-based criterion that specifies what is better quality. The educational resources will provide an introduction to the field of quality measurement and inform users how to best use NQMC.
Despite having the highest incomes, people in Britain have the worst quality of life in Europe, a study shows. (Source: PressTV, October 2009)
Presentation delivered by Joe V. Selby, M.D. at the National Comparative Effectiveness Summit, Oct. 12, 2011
Alongside the emergence of many technology-based ways of capturing PRO data is the need to assure measurement equivalence across and among these methods and modes of administration (Coons et al., 2009). This becomes especially important if multiple methods or modes are utilized within a single trial. For the purpose of this paper, we have adopted the distinction made in the PRO Guidance between PRO instrument administration modes and data collection methods.
For many treatments, we know neither the true probability of success nor how to explain it clearly to a sick and worried patient. The Affordable Care Act has begun a dialogue about how to generate this probability evidence, and put into motion a number of initiatives to help fill the present knowledge gap. The Patient-Centered Outcomes Research Institute will do vital work to generate the comparative effectiveness studies that inform doctors of a treatment's risks.
