Rigor: lost in the quest for evidence-based practice.

Area of Science:

• Quantitative research methodology
• Clinical trial design
• Evidence-based practice

Background:

• Randomized controlled trials (RCTs) are foundational to evidence-based practice.
• Concerns exist regarding the methodological rigor of some RCT designs.
• The importance of robust study design for reliable scientific conclusions is paramount.

Purpose of the Study:

• To highlight a critical lack of rigor in the design of randomized controlled trials.
• To examine fundamental principles of quantitative research design.
• To underscore the implications of design flaws for scientific validity.

Main Methods:

• Review of basic tenets in quantitative research design.
• Analysis of population delineation and sampling techniques (probability and non-probability).
• Definition and differentiation of random selection versus random assignment.

Main Results:

• Randomized controlled trials may lack rigor by using random assignment without random selection of subjects.
• This distinction is critical for the internal and external validity of trial findings.
• The current application of randomization in RCTs may not fully meet rigorous quantitative design standards.

Conclusions:

• The rigor of randomized controlled trials is compromised when random selection of participants is omitted.
• A gap exists between the ideal quantitative design and the common practice in RCTs.
• Addressing these design limitations is essential for strengthening the evidence base in healthcare and other scientific fields.