Describing diversity of real world data sources in pharmacoepidemiologic studies: The DIVERSE scoping review and tool

Study type

• Study topic:
  Other
• Study topic, other:
  Methodology to generate Real World Evidence
• Study type:
  Not applicable
• Scope of the study:
  Method development or testing

  Scoping review (including literature review)
• If ‘Not applicable’, further details on the study type:
  Scoping review and tool development

Population studied

• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  0

Study design details

• Study design:
  scoping review
• Main study objective:
  To list and summarize existing tools and recommendations for the collection and reporting of diversity in data sources used in RWE. To develop a tool to represent data diversity.
• Data analysis plan:
  In the scoping review, articles were identified through searches in PubMed and Embase and by expert knowledge of relevant literature. The sensitivity of the search was validated against a set of relevant papers identified by experts in the working group. Articles were screened on title and abstract in duplicate using a standard screening tool and will be included if they contain recommendations or guidelines for the collection and reporting of (diversityof) data sources, report tools to describe data sources or provide descriptions of multiple data sources within a network. Information was collected from the selected articles using a data extraction tool, applied in duplicated by two independent researchers. Extracted information was analysed in accordance with recommendations in the JBI Manual for Evidence Synthesis, and will follow the Arksey and O’Malley framework for collating and summarizing results in a narrative review. Counts of different types of articles was provided.
• Summary results:
  Scoping review: Across 91 selected documents, 9 dimensions used to describe Real World Data Sources (organization accessing the data source, data originator, prompt, inclusion of population, content, data dictionary, time span, healthcare system and culture, and data quality). Thirty-six themes were identified within the dimensions; ; Tool: available at this link https://docs.google.com/spreadsheets/d/1yRCmjb71smATl5bk1yJTNcy-o4HyKZfD/edit?gid=428534828#gid=428534828 and as a supplement in this Catalogues entry, in section Study Documents