Patient outcomes

In the context of registries used for evaluating patient outcomes, a patient registry is defined as an organised 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.

Registry Types

In drug safety the most common types of registry are:

  • Disease registries: are composed of patients who have or have had a disease or condition of interest. They allow the population with a particular disease to be well-characterised and an adverse event profile for different treatments to be established.
  • Product (drug) registries: are composed of patients exposed to a health care product (drug or device). Product registries allow study of drug utilisation patterns, including for example, off-label use.
  • Pregnancy exposure registries: focus on possible exposures during pregnancy, post partum and also effects in offspring.

Registries may be used as surveillance systems for monitoring of adverse events. They may also be created to quantify and evaluate risk and benefit throughout a product’s lifecycle. Thus registries have become regarded as complementary resources for the purposes of supporting the requirements of risk management plans to systematically collect data from real world clinical practice. Many registries are high quality studies designed to address a specific problem, when randomised controlled trials are not feasible, particularly for the evaluation of rare adverse events, or when results of randomised trial are not applicable because participants are highly selected and differ to that target population of interest.

Registry Based Studies

The DSRU offers a complete package for registry based studies, including the following steps, as required:

  • To evaluate circumstances and make recommendations regarding when a registry is preferred.
  • To define registry focus, scope and goals, taking account of regulatory and marketing authorisation holder (MAH) requirements for a RMP and other key stakeholders.
  • To develop study protocols for registries to document and describe study objectives, design considerations including size and duration, participant inclusion/exclusion, outcomes, data collection and governance procedures, ethical and data privacy obligations, possible sources of bias and other limitations. Bespoke statistical analysis plans will also be provided.
  • To provide a detailed project plan including timescales that reflect study inception, execution and closure as well as other key milestones and project deliverables important in the support of RMPs.
  • To recruit and retain health care professionals and patients in the registry, using a team of research facilitators.
  • To provide data management and assure data meet required standards of quality.
  • To analyse and interpret data to evaluate study outcomes.
  • Ensure publication of results in peer-reviewed literature and present results at scientific meetings in order to introduce information into the public domain.

Examples of DSRU registries

  1. Our Specialist Cohort Event Monitoring (SCEM) methodology is ideal for setting up a registry in secondary or specialist care. We have completed three SCEM registry studies, with others underway. For more information see the PASS Studies page or this publication.

  2. The Drug-induced Arrhythmia Risk Evaluation (DARE) study:
    • Drug Induced arrhythmia (DIA) is a major concern for patients, prescribers and marketing authorisation holders. Many are secondary to important drugs.
    • The DARE study was a collaboration between DSRU and St George’s Medical School, London, funded by the British Heart Foundation
    • It used a prospective case-control study design to systematically record and characterise incident cases of DIA. The dedicated epidemiological study team consisted of the DARE project manager, a team of four regional research nurses and an administrator.
    • It comprised an epidemiological study (to follow up cases of ventricular arrhythmia in England and compare them to matched controls) and a genetic study (to analyse DNA for polymorphisms and mutations).
    • Further information about the DARE study is published here and in the papers listed below.