Detail

The purpose of your registry will be to provide information about a specific patient population for whom the results will be applicable.

You will need to carefully select the population of patients you are going to include in your registry, usually by defining an exposure, e.g.:

Selecting patients for a registry is a multistage process. It should begin with an understanding of the target population. This is particularly important if you will not include the whole population in your registry (e.g., if participation will not be mandatory as a condition of service provision or access to a drug). To do this, you will need to have clear definitions of the inclusion and exclusion criteria and document the rationale for these criteria. A common feature of registries is that they have less inclusion and exclusion criteria, enhancing their applicability to a broader population.

After you identify your patient population, you should next select the institutions and providers from which patients will be included in your registry.

When deciding on the data to include in your registry, using a scientific approach to consider how each will be used to address your agreed objectives is helpful. Exposures are the treatments, procedures, health care services, and diseases that you will want to study to better understand their effect on the status of a patient, i.e., the outcome. When considering these, you must also consider potential confounding variables, which can complicate relationships between exposures and outcomes.

You may need to include additional information about your exposure variables, such as dosage, duration, route of exposure, or adherence. At every stage, however, you must strive to address your registry objectives as efficiently as possible.

Registry data can be obtained from patients, clinicians, medical records, and linkage with other sources. Most renal registries are longitudinal in design, registering patients over time and following them up to evaluate outcomes. Patient registration is best done as they become eligible throughout the year, as this minimizes the risk of eligible patients dying before they are registered (and not appearing in the registry). However, this relies on clinicians remembering to register the patient as soon as they meet the inclusion criteria. Electronic health records can help here in a number of ways, either automating the process of flagging eligible patients for extraction to the registry or producing a list of eligible patients for manual reporting at agreed intervals.

The frequency of follow-up also needs consideration, but as long as all eligible patients are included in the registry, the follow-up of patients can be carried out at intervals, e.g., quarterly or annually, with dates captured for all data elements and outcomes.

As with other design aspects, careful attention must be paid to the burden of data collection on clinicians and patients. It is better to have a small dataset of high quality covering an entire (or representative) population than a large dataset of low quality covering a selection of the population.

If your registry has only descriptive objectives or is primarily for quality assurance you may not need to consider the size it needs to be to have the statistical power to address an objective. In these cases, practical considerations may limit your registry’s size and scope, though it will still be desirable for your registry to represent the whole population. Ideally, the registry will include the entire population with the condition of interest.

If your objectives are limited to comparing the effectiveness of treatments, which don’t require your registry to be representative of your country, you will need to look at a range of assumptions about the size and duration of your registry and consider what statistical power you will have to be able to detect differences. As part of your governance work, you will need to be able to justify the number of patients included in the registry and the  processing of their data.

Appendix A in the AHRQ guidelines covers the topic of study size calculations for registries, which is also covered in one of the ERA Registry’s  educational series. You may need to consider additional factors when determining the most appropriate registry design. If you are planning a product safety registry, a rare disease registry, a medical device registry, or a quality improvement registry, the last section in Chapter 3 of the AHRQ guideline highlights some additional design issues you should consider.

There are so many things to consider and perspectives to take when designing a registry that it can be helpful to use information systems methodologies to create a series of models to summarize things in ‘pictures.’ These reduce the distraction of small details and help you to see how the ‘real world systems’ of your registry work with each other.

While it is important to involve information systems experts in this process at an early stage, their role should only be facilitative. The involvement of content experts (usually the clinicians and patients for renal registries) is vital, with good communication between all team members.

There are a number of methods that can be used to create these models, such as Unified Modelling Language and business process modelling. In general, these methods begin with the information systems expert conducting semi-structured interviews with content experts before an interactive
workshop is held to build the model through consensus and resolve ambiguities. For further details on specific methods for creating these models, see Chapter 6.5 on the PARENT guideline.