Sleep and circadian disorders are extremely common. For many of these we know little about the natural history, whether different subgroups exist and effects of current therapies. Thus, developing specific registries for common sleep and circadian disorders would provide a basis for addressing these questions.

For some aspects, e.g., studies of inadequate sleep, impact of snoring and circadian disruption, would be facilitated by developing a specific sleep/circadian cohort with in-depth phenotyping. This strategy has worked extremely well in other areas, e.g., cardiovascular disease. The lack of this type of cohort for sleep and circadian disorders is a barrier to progress in this area. The high prevalence of these disorders and their known public health significance argue that development of such a cohort would be a game changer and accelerate progress in this new area of medicine.

Such a cohort could address several compelling questions:

a. What is the natural history of short sleep across the lifespan?
b. What is the impact of snoring? Does it lead, as has been proposed, to vibration injury to carotid arteries with accelerated vessel wall damage?
c. Are there different subtypes of individuals with the different sleep and circadian disorders?
d. What is the natural history of shift-workers and what types of shifts lead to increased risk for cardiovascular disease?

Problems with sleep and circadian rhythm and the relevant disorders are common. There are multiple accredited sleep centers for clinical purposes in the United Sates. They use common phenotyping platforms that could be the basis of some aspects of addressing this critical challenge. Moreover, most CTSA programs have a sleep study component. There are patient support groups for sleep apnea, insomnia, restless legs syndrome and narcolepsy. Thus, these groups could be marshaled to help in this effort. There is already a Sleep Research Network that was founded by the field itself. It is currently based on volunteer effort and there are no resources to support it. It could be the basis for future activities in this area.

The envisioned impact of an integrated Care Center Network and Patient Registry is to create a resource that:

• Informs the understanding of interstitial lung disease (ILD), its epidemiology and natural history;
• Assists to understand treatment patterns associated with optimal outcomes that will inform an emerging standard of care and development of treatment guidelines;
• Facilitates patient and clinician engagement in support of future prospective studies;
• Furthers study of biomarkers and predictors of disease and severity;
• Documents patient experience of living with ILD as described through patient reported outcomes (PRO) including quality of life, functioning, and symptoms;
• Generates new hypotheses and new endpoints in support of future studies;
• Increases awareness of relevant issues and needs among the immediate ILD community;
• Provides the opportunity to promote and inform policies in the larger health care community in support of those with ILD

With the establishment of collaborations between several partners, we initiated the PFF Care Center Network and Patient Registry in 2014. The Care Center Network and Patient Registry has since expanded to 21 centers regionally dispersed throughout the United States. The challenges of effectively and efficiently investigating the cause, care and treatment of pulmonary fibrosis are predominantly those of organization and integration of effort. Expertise is present throughout the United States. We suggest that with the continued expansion of the Care Center Network and Patient Registry, those challenges will be overcome and the focus of the fibrosis community efforts can be on diligently investigating the diseases that devastatingly affect patients. An integrated repository of well-phenotyped patients and biologic specimens is the first step in Precision Medicine for patients with interstitial lung disease and pulmonary fibrosis.

Can be modeled on the ARDS/PETAL Network, but more broadly implemented for epidemiology and pragmatic studies.

This Registry for AF patients would help identify new patient phenotypes, provide detailed information about the progression of disease and its consequences, and benefits of existing treatment options. The Registry could also be used to conduct other studies and trials.

Large numbers of patients are faced with atrial fibrillation and this is recognized as an area of high priority investigation. In addition, expertise exists for developing and maintaining a registry.
Post-operative atrial fibrillation (AF) is the most common complication after cardiac surgery with incidence in the range of 20-50%. The consequences include increased morbidity, mortality, increased hospital length of stay and an annual cost of nearly $1 billion in the United States. It is well known that there are many different mechanisms underlying AF and that these differ from patient to patient.

develop registry provide contemporary data of local, regional and nation wide EMS practices in managing OHCA to address and develop successful resuscitation strategies across gender, age and race categories.

combining ROC (Resuscitation Outcomes Consortium) and CARES (Cardiac Arrest Registry to Enhance Survival), the two largest North American existing OHCA registries have different (regional) foot print, quality control measures and thus goals. CARES was developed as U.S. based surveillance registry across majority of states and not a research database; therefore, collected only the minimum number of data elements that are known to be essential in the response and treatment of OHCA. ROC is a North American registry conducted at 10 major regions with a detailed and high quality CPR process data providing not only the OHCA rates but also detailed CPR characteristics. Combining a large geographic foot print with sites with established quality controls would offer insight into rural, suburban and urban OHCA resuscitation dynamics on which resuscitation strategies would be based.
It is well recognized that there are marked variations in survival from OHCA and IHCA among centers as well temporal trends, however, factors associated with it are incompletely understood. Ongoing quality data are needed to advance our understanding of resuscitation care, as well as variations in EMS/ED practices.

See attached file

Critical Challenge