Registries are set up for collection and maintenance of information of people with similar conditions. These individuals must consent to involvement by being physically present or allow their data to be used in future research. On the other hand a repository is specifically for storage of identifiable specimens. They are collected, indexed and stored for future use in medical research or other relevant studies.
Therefore, a registry must be very organised. It makes use of various study methods to collect data in a uniform way in order to analyse specified results of a group of people affected by an identifiable disease, medical condition, type of exposure e.g. to radioactive elements, or a new outbreak that is yet to be identified and classified.
Purpose of a registry
Registries are started and maintained for specific reasons depending on the eventual or intended use of the information.
- Determine the history of a disease- Every disease has a life span. It has an original state in which it was either harmless to humans or before it was encountered. It has stages of development where it is most active and produces symptoms that are easily identifiable and then it has its death or control period in which it is eliminated from the body or controlled through medication. It is important to understand the natural history of the disease, how it was managed before technology and what caused it in the first place.
- Determine effectiveness of treatment – Disease causing bacteria is naturally evolving just as any organism would. This is increasingly causing resistance to particular medication when used over a long period of time. Registries allow long term observation of patients and makes it easier for medical practitioners to identify resistance to specific drugs. This reduces the number of deaths greatly through an immediate change in the medicine to new variations that will eliminate or contain the disease.
- Determine cost effectiveness of treatment or health services – Registries eliminate the need for prolonged observation and drastically reduce the cost of treatment for the public. It becomes easier to tell what combination of drugs work best and reduce the number of times the patient has to come back for check-up.
Creating a registry
So, you want to create a registry, here are elements in the standard operating procedure manual that you need before you can give the process a go ahead
- You must always set specific goals:
- Data quality. What quality checks are in place, what more do you need to achieve full data quality and who is in place to manage the data and perform quality assurance checks.
- Training – Your entire team must be trained for this system. This doesn’t mean that they must all have access to it, it means they must be aware of it, how it runs and why it is important to your cause.
- Specific measures of achievement. This sets a cap on when you stop collecting data, it basically alerts you when you have what you need to achieve your goals.
Who are your key stakeholders and what is their role in your process? You must define this before you engage them because you cannot serve everybody’s interests and still achieve yours 100%.
Who else shares your cause or see’s things as you do? Who would be willing to fund your project and to what extent? What do they need in return and is it possible to fulfill? Again, clarity is key.
- Your team
You need a qualified team of people to help run the registry. Extra training may be required and some team building to ensure coordination is maintained throughout the process. The goal must always be in sight and everything they do must be towards achieving their goals.
- Governance and oversight
Without leadership, you have a circus of people running around doing everything without a direction. Your goals might never be achieved without strong leadership.
- Consider the scope
Identify the area of interest, zone in to the scope of the disease or outbreak you are interested in and work diligently to achieve your results. Do not over stretch the scope or sample size for better and more comprised results.
- Project plan
Write out a work plan clearly assigning roles with clear timelines for each action. This should be accompanied by a checklist of items required to achieve the action as well as a budget for proper planning and execution of the action.
- Determine what will happen when the registry ends.
You must state clearly where the information in the registry goes or what happens to it once the registry ends. Decide from the onset if the database will be maintained, stored or destroyed.