Listening to the Patient Voice in Narcolepsy: Diagnostic Delay, Disease Burden, and Treatment Efficacy.

Study Objectives: Describe common symptoms, comorbidities, functional limitations, and treatment responsiveness among patients with narcolepsy. Investigate the effect of pediatric onset of narcolepsy symptoms on time to diagnosis of narcolepsy and presence of comorbid depression.

Methods: Cross-sectional survey of 1,699 people in the United States with self-reported diagnosis of narcolepsy.

A Framework for Incorporating Patient Preferences Regarding Benefits and Risks into Regulatory Assessment of Medical Technologies.

Background: In response to 2012 guidance in which the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) stated the importance of patient-centric measures in regulatory benefit-risk assessments, the Medical Device Innovation Consortium (MDIC) initiated a project. The project was used to develop a framework to help the Food and Drug Administration (FDA) and industry sponsors understand how patient preferences regarding benefit and risk might be integrated into the review of innovative medical devices.

Methods: A public-private partnership of experts from medical device industry, government, academia and non-profits collaborated on development of the MDIC patient centered benefit-risk framework.

On the path to a science of patient input.

It is early days in the creation of a science of patient input. Participants are establishing rigorous methods to better integrate patient perspectives, needs, and priorities throughout biomedical and bioengineering R&D and care delivery to patients. To assess progress and unmet needs, FasterCures tracked more than 70 collaborative initiatives clustered in six categories that are defining and shaping this developing field.

From passengers to co-pilots: Patient roles expand.

The premier position of medical research on the U.S. national policy agenda offers an unprecedented opportunity to advance the science of patient input and marks a turning point in the evolution of patient engagement.

No association found between the detection of either xenotropic murine leukemia virus-related virus or polytropic murine leukemia virus and chronic fatigue syndrome in a blinded, multi-site, prospective study by the establishment and use of the SolveCFS BioBank.

Background: In 2009, a retrospective study reported the detection of xenotropic murine leukemia virus-related virus (XMRV) in clinical isolates derived from individuals with chronic fatigue syndrome or myalgic encephalomyelitis (CFS). While many efforts to confirm this observation failed, one report detected polytropic murine leukemia virus (pMLV), instead of XMRV. In both studies, Polymerase Chain Reaction (PCR)-based methods were employed which could provide the basis for the development of a practical diagnostic tool.

Continuing medical education challenges in chronic fatigue syndrome.

Background: Chronic fatigue syndrome (CFS) affects at least 4 million people in the United States, yet only 16% of people with CFS have received a diagnosis or medical care for their illness. Educating health care professionals about the diagnosis and management of CFS may help to reduce population morbidity associated with CFS.

Methods: This report presents findings over a 5-year period from May 2000 to June 2006 during which we developed and implemented a health care professional educational program.

A train-the-trainer education and promotion program: chronic fatigue syndrome--a diagnostic and management challenge.

Background: Chronic fatigue syndrome (CFS) is a complicated illness for providers and patients. Fewer than 20% of persons with CFS have been diagnosed and treated. For providers, compounding the issue are the challenges in making a diagnosis due to the lack of a biomedical marker.