Development and initial psychometric properties of the Research Complexity Index

Area of Science:

• Clinical research methodology
• Health services research

Background:

• Research study complexity, influenced by factors like intervention type and design, necessitates significant resources and expertise.
• Existing instruments for measuring study complexity across diverse research designs are limited.
• Accurate assessment of study complexity is crucial for effective resource allocation and trial management.

Purpose of the Study:

• To develop and establish the initial psychometric properties of an instrument designed to scale research study complexity.
• To create a tool that can quantify the complexity of research studies.

Main Methods:

• Developed an instrument (Research Complexity Index) following technical and grammatical principles for clarity.
• Conducted face, content, and cognitive validity testing using surveys and interviews.
• Performed pilot testing with 31 participants scoring 25 items across two exemplar protocols.

Main Results:

• The Research Complexity Index demonstrated face, content, and cognitive validity.
• Internal consistency reliability (Cronbach's alpha) was 0.586 for Protocol 1 and 0.764 for Protocol 2.
• Inter-rater reliability was fair (kappa = 0.338).

Conclusions:

• Initial pilot testing indicates the Research Complexity Index possesses validity and acceptable reliability.
• Further refinement may enhance the instrument's reliability, providing a comprehensive method for assessing study complexity and resource needs.
• The tool has the potential to aid in quantifying resources, such as staffing requirements, for research studies.