Patient registries are effective instruments for improving healthcare in medical specialty societies and patient foundations. In order to be effective however, planning is key in order to build a successful patient registry. A patient registry, or disease registry, is best described as “an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes.”
There is immense variability in the size, requirements and scope for patient registries. While the extent of flexibility confers significant potential, it also mandates a good amount of planning to ensure satisfactory date collection in order to be able to measure result and outcomes. There are certain crucial mistakes that could possibly tamper with the efficiency of a patient registry.
The success of each individual patient registry is dependent on its design, operation and evaluation process. Here are simple steps that will help chart out the perfect patient registry to suit your needs.
Articulate the Purpose of the Registry
This is the foremost step to undertake when establishing a patient registry. Having clearly defined goals and the supporting rationale will make it easier to assess whether the patient registry is the right fit to suit your area of interest.
Examples of key questions during articulation of purpose include:
- What is the cause of the disease in nature?
- What are the possible effects and complications of treatment?
- How is the disease affected by various clinical practices?
- What are the disparities in delivery?
- How do quality improvement programs affect patient outcomes?
- What are the common resources used for typical patients?
Determine whether the Registry is Capable of Achieving Set Purpose(s)
There are two important questions to consider here:
- Does the visualized patient registry offer solutions for the specific questions asked above?
- Is prospective data collection through the registry a suitable means of achieving scientific objectives?
For example, there might be data collected for the particular condition you’re targeting. You can access this by linking your system with the respective data source. However, one needs to be mindful of this decision as the quality of the collected data will depend on the efficiency of that patient registry.
Identify Important Stakeholders
This step should be undertaken at the start of the planning process to assess the key parties for whom the research questions matter. The key stakeholders will help determine the best data type and scope to concentrate on.
Key stakeholders may include:
- Public health authorities
- Epidemiologists
- Biostatisticians
- Patients
- Patient advocacy groups
- Product manufacturers
Assess Feasibility
This is often related to funding. The expenditure required for your registry will depend on the number of patients, audits required, scope of data, etc. If a well-structured patient registry promises sustainability, it may attract funding from foundations and the government.
Build and Train a Patient Registry Team
A vast skill set is required for the smooth functioning of a patient registry. The right team has a direct impact on the efficiency of a patient registry.
The following expertise may be required for a qualified registry team:
- Project management
- Medical specialists in the area of focus
- Data collection software specialists
- Patient advocacy supporters
Consider Required Data Scope and Rigor
The following variables may shape the scope of data:
- Number of patients
- Number of clinical sites
- Size of data points
- Duration of data collection
- Financing
- Geography
Define the Core Data Set, Target Population and Patient Outcomes
The core data set should be chosen by experts in the fields of biostatistics and epidemiology and should be relevant in the context of the current clinical and scientific climate. The data elements should directly relate to the purpose of the registry.
The target population constitutes people to whom the registry findings will apply. Therefore, the target population serves as the foundation for planning as it represents the group of people to be affected by the registry’s results.
The patient outcome should be highlighted early on as they will help designers prioritize the more important interests.
Choose the Right Patient Registry Software Solution
Our patient registry software, allows you to build a successful patient registry program that can rapidly meet all your objectives.
