Planning the Ideal Patient Registry – A Guide
Successfully setting up an effective patient registry adds remarkable value to the research setup of every health organization and therefore improves global health. The efficiency of every specific patient registry, depends on the attention made towards design, operation and evaluation processes. In addition to the numerous benefits of massive patient registries, smaller forms are ideal for tracking specific a group of related disease conditions in the patient panels of health care providers.
The first major step in the establishment of an ideal patient registry is determining the perfect resource requirements, size, and scope.
These keynotes and the steps that follow can be summarized under the following points :
Analyze and Articulate Purpose of Registry
This is the most basic and important part in the planning of a registry as it involves proper analysis to come up with clearly defined goals and a rationale to support them. These facilitate the evaluation of whether or not a registry will succeed in the capture of the specific information significant to the purpose of the entire program. When the specific goals are defined, the need for certain data is clarified and the purpose of the registry can be translated into questions which the registry is then designed to provide valid answers for.
Articulation of the registry’s purpose should consider the interests of collaborators and audiences in the definition of the process for data collection, management and analyses.
Examples of key points during the purpose articulation step in registry planning include;
Cause of disease in nature
Effects and complications of treatment
Varying clinical practices
Possible delivery disparities
Effects of improvement programs on patient outcomes
Commonly used resources for typical patients etc.
Verify and Measure the Potential of the Registry Achieving its Purpose
The objective of this step is to make sure that setting up the visualized patient registry has the potential of bringing solutions to the specific questions asked. When this is considered early in the planning process, it directs developers towards a design that is based on the extent of availability of significant data, the application of high-quality methods in data collection, and quality and accessibility of already existing data. For example, there might be an existing pool of high-quality data on your particular condition which can be reached by linking your system with the other data source. However, enough thought should be given to this consideration because the quality of the collected data is dependent on the efficiency of the other registry.
Identification of Important Stakeholders
Identify the major stakeholders of every patient registry early enough during its planning. They could be your patients of interest, personnel for data collection and analysis, and even the agency that monitors or regulates post marketing studies. These stakeholders can contribute immensely to the determination of the best data type and scope to focus on.
This step addresses the feasibility of your new registry project and is often related to funding. How much required for your registry will depend on the scope, data collection rigor, and the required audits. For example, a larger number of patients implies the need for potentially wider representations for characteristics which normally require more expenditure. Another factor that can contribute to expense is the methods for data collection. With the promise of sustainability and impact on development within a particular area in health, well-structured patient registry projects attract funding from foundations, governments, product manufacturers, patient groups, professional societies, health plan providers etc.
Build a Team
Many different skill sets are required in the smooth setup and functioning of a patient registry. A good team guarantees efficiency and it’s size and expertise depends on the size and scope of the registry parameters.
An ideal team should include;
Management for coordination of all activities and processes
Database management that ensures the proper collection, grouping, organization, and storage of data. This is vital in tools related to electronic data. Data+ Research is an example of a platform that provides expertise in this domain ensuring the quality of data in every patient registry they control.
Legal follow up personnel for the respect of issues like patient privacy.
Expertise in quality assurance.
Determine Required Data Scope and Rigor
This analysis can be made considering size, duration, financing, geography, and setting. The scope can also be shaped by uncontrollable regulations like public health policy, interests related to national research, and regulatory requirements.