Registries are valuable instruments for enriching knowledge and for supporting fundamental, clinical and epidemiological research. These data are also crucial for the planning of healthcare services. International operability of registries and databases, as well as the use of appropriate coding systems and core data sets, enable the necessary pooling of data for public health and research purposes. the adherence of good practice guidelines in the field is of paramount importance, particularly concerning multi-stakeholder participation across all aspects of registry design and governance. All stakeholders should establish their national plans/strategies for the sustainability of registries at European and global levels. Patient registries and data collection need to be flexible for future needs, i.e. adaptable to serve regulatory purposes, where required. Patient registries and data collection need to be internationally interoperable as much as possible and the procedures to collect and exchange data need to be harmonized and consistent. Searching global data need to comply with data protection requirements and preserve data sovereignty. a minimum data set needs to be implemented and held by all compliant registries. Moreover a data dictionary will allow for data definition and data mapping between local registries. This approach guarantees uniqueness of attributes created, relationships between data, proper value ranges for each data field global/local registries ‘hold’ one of a pair key for patient’s identification process.
The development of registries has gained momentum and has become increasingly important in recent years. the United States Food and Drug Administration (FDA) announced a risk minimization plan in March 2005, listing registries as an important risk minimization tool.
In a survey conducted by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), 44% of respondents indicated that their organization (e.g., pharmaceutical industry, medical device industry, contract research organization, or academia) are currently involved in one or more patient registries.
The need to record chronic pain patients in Greece, aiming at conducting more clinical studies monitoring treatment according to guidelines urged the Hellenic Society of Pain Management and Palliative Care (PARH.SY.A) to proceed to the creation of a Special Registry for Patients suffering from Chronic Neuropathic Pain (NP).
Initially, a working group was created, which, following a series of meetings, agreed to create the first pain registry for NP in Greece. One of the main reasons for this attempt was the creation of a user friendly and at the same time useful application for the medical community.
The user can enter the application at any time via internet using his/her computer, tablet or even through smartphone. Our initial submission at the personal data protection authority was in September 2014 . License approval was obtained in May 2016. Entry initiation began in June 2016 and ended in March 2017. There were 14 pilot sites.
In the account’s landing page, the user can easily and quickly find information on his patients and add a new one. Baseline patient data (demographics and social-financial data) were recorded. the following information were additionally registered: History, Type of chronic pain, Type of neuropathic pain, History of neuropathic pain, Pain medication, Interventional techniques and Other treatments.
Of 6850 patients recorded in a 22-month period, 1027 patients had chronic neuropathic pain.
The Patient Registry of Neuropathic Pain can be used to evaluate:
tolerability of drugs of choice (anticonvulsants, antidepressands, and opioids) or the combination treatment in clinical practice.
Conclusions from greek registry for chronic NP
Lower than expected number of records
Pain centers not officially established
Pain centers operating once/twice per week
Need to set up a team of data managers
Need to include all patients with chronic pain
Need to be institutionalised by competent National Authorities
Our mission Make the Registry of Patients with chronic pain available in every country through European or global scientific societies.
Next steps Inform the medical community through data recorded for clinical management improvement.
Form task groups for: a) treatment efficacy studies, b) scientific research purposes, and c) entry of a sufficient number of patients aiming at the publication of articles from our system’s data.
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