Defining key design elements of registry-based randomised controlled trials: a scoping review

Area of Science:

• Clinical Trials Methodology
• Health Services Research
• Public Health

Background:

• Traditional randomized controlled trials (RCTs) have limitations including high costs, failure rates, and limited external validity.
• Prospective, registry-based randomized controlled trials (RRCTs) offer an alternative by utilizing existing registries for data collection.
• This scoping review aims to identify key design elements of RRCTs and characteristics of the registries they depend on.

Purpose of the Study:

• To explore the current literature on registry-based randomized controlled trials (RRCTs).
• To identify essential design elements for conducting RRCTs.
• To characterize the clinical registries crucial for RRCT methodology.

Main Methods:

• A scoping review was conducted following Joanna Briggs Institute guidelines.
• Searched four databases (Medline, Embase, CINAHL, Scopus) from inception to June 2018.
• Included search terms related to registry-based randomized controlled trials (RRCTs).

Main Results:

• 17 articles met inclusion criteria from 2369 identified articles.
• Studies were investigator-initiated, published between 1996-2017, and utilized disease, procedure, or health service registries.
• RRCTs offer lower costs, reduced administrative burden, and enhanced external validity, addressing public health questions.

Conclusions:

• Registry-based randomized controlled trials (RRCTs) show potential for informing clinical practice and health policy.
• Addressing issues like ethical conduct, data integrity, and universally accepted definitions is crucial for optimizing RRCT utility.
• Further development is needed to establish standardized criteria for RRCT definition and implementation.