A clinical data patient registry is an organized system that employs observational study methods to gather data. This data helps calculate detailed outcomes for a specific population characterized by a particular disease or condition. The results from patient registries are vital in providing real-world data for clinical practice. Data from a clinical data patient registry can serve a predetermined purpose, whether clinical or scientific. You need the best practices for patient registries to improve the chances of success.
Registries often work in a coherent manner, or rather should, as depicted below.
- Obtain Data
- Identify and enroll patients
- Collect data from different sources
- Check and collect data
- Delivery and Coordination
- Provide real-time feedback
- Produce patient level reports
- Share information with patients and providers
- Quality Improvement
- Create population level reports
- Facilitate quality reporting
Best Practices for Patient Registries
While registries have immense scope in improving patient outcomes and patient care, not all registries turn out to be the same. There are many loopholes behind this lapse in success. You need to properly plan and execute a registry from start to finish. Here are some of the best practices for patient registries that will increase the chances of achieving the specified study outcome.
1. Keep the End Goal in Mind
Every patient registry is different, with a predetermined purpose, as described above. A patient registry is successful only if it obtains the specific purpose it was established for. In order to do this, you should design the study keeping the end-user and the end goal in mind.
You should make efforts to protect the interests of the sponsors and stakeholders. Every project has different aims and objectives, and the study should aim to achieve that right from the beginning. Identify your project goals, some of which may include:
- Identification of any data gaps
- Provide maximum effectiveness of treatment
- Improve patient care and outcomes
- Reduce treatment expense
- Identify safety patterns
2. Informed Patient Recruitment
While this is often taken for granted, patient recruitment can be a serious challenge without proper planning. There should be efforts to identify any technical and logistic issues in the planning stage. There is also some level of hesitation from the patients about participating in the trial. The following patient recruitment methods can help achieve the desired goals:
- Recruit patients through the physician who provides care for them
- Tell the patient how their contribution will make a difference, and how. For example, will it improve patient outcomes? Will it promote better research avenues for the specific disease or condition?
- Ensure the surveys are short and simple to understand to facilitate patients as much as possible
- Provide participants with progress on the study through a newsletter, report, etc. monthly
- Explain how patient confidentiality is maintained and ensured
3. Develop a Data Management Manual
Data collection is a vital step in ensuring the success of a patient registry. It is important to assimilate the purpose of the registry with the data collection methods to guarantee the registry’s efficacy. You can develop a data management manual to ensure the registry is on the right track and address the following:
- What is the project objective?
- The types of data entry required
- The methods to use to address queries
- Outline duties of people handling the data
- Data quality assurance tools
The success of any patient registry depends on the registry software vendor you choose. Given the scope, there are several patient registry software available in the market. You need to choose the right patient registry software solution that can be steered towards the specific goal of your study. It should also ensure flexibility for the addition of data as well as ensure patient data security.