v-REGISTRY is a worldwide secure IRB (n. 2024-86/46418926) approved vein-lymphatic investigators-initiated registry, developed according to the highest quality standards (Registries for Evaluating Patient Outcomes Agency for Healthcare Research and Quality 2020).
RATIONALE
Current Vein-Lymphatic practice is missing a global homogeneous Real World Data collection, cleaned by major potential biases (life-style, occupational settings, local socio-economic features, etc), and including device, graduated compression and venous active drugs use & impact analysis. The data is confirmed by the Agency for Healthcare Research and Quality (AHRQ).
PRIMARY ENDPOINTS
to report:
1.geographical & race EPIDEMIOLOGY
2.disease NATURAL HISTORY
3.SAFETY, CLINICAL & COST-EFFECTIVENESS of healthcare products and services
4.Quality of care
5.Quality of Life
FORMAT
- HEALTH SERVICE registry
(clincal exposition)
- PRODUCT registry
(devices, compression, drugs)
- CONDITION registry
(co-morbidities)
UNIQUENESS
Up to our knowledge, v-REGISTRY is the only worldwide collecting registry, moreover in multiple languages. Moreover, the collected data are extremely unbiased considering the many details included thanks to the special software allowing data collection beginning even before the patient comes to the visit, therefore maximizing both the available information and the time consuming.
DATA PROTECTION & ETHICS
v-REGISTRY follows the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as the GDPR Regulation (EU) 2016/679, establishing protections for the privacy of individually identifiable health information created and maintained by health plans, healthcare clearinghouses, and most healthcare providers.Patients and Healtchare professionals can not receive any economic benefit from their involvement in v-Registry. The not for profit initiative is supported by free donations and unrestricted grants.
INDEPENDENT REVIEWERS & QUALITY ASSURANCE
An intercontinental team of independent reviewers is involved to guarantee quality and exclusion of conflicts of interest. Users of the registry undergoes training on the platform use before being validated as collectors. The collected data are reviewed for quality and consistency by the independent reviewers board, both as rough values and as related produced evidence. In case of inconsistency, a remote and eventually in person audit is performed. An annual report of the v-Registry performance is delivered both online and in a presential meeting.
DATA COLLECTORS BENEFITS
Healthcare professionals entering data can not be paid or receive economic benefits for such service. The mission is purely scientific and aimed to improve vein and lymphatic patient care.
All the data collectors are invited with free registration to present their report during the annual meeting dedicated to v-Registry.
Collected data are available in anonymous form for all data collectors.