Strenghts
More reliable and credible for a causal inference than any other empirical research methods (Diaton & Cartright, 2018; Yartev 2017)
Rigorous methodology: generally more strengths than weaknesses (Battacherjee, 2012)
Most rigorous research method (Yartev, 2017)
Randomization: best means of minimizing confounding -Confounding occurs when an outcome is affected by additional factors (Bhattacherjee, 2012; Yartev 2017)
Large RCTs are the best at detecting small to moderate clinically significant findings
High internal and external validity
True experiment: Treatments can be directly compared and the better treatment can be identified (Yartev, 2017)
Bias is minimized due to randomization (Bhattacherjee, 2012; Yartev, 2017)
Due to randomization, groups can be compared in terms of known as well as unknown factors (Yartev, 2017)
Statistical reliability, quickly interpreted statistical test of significance.
Considered the gold standard and is therefore more publishable
Limitations
Can have problems with methodology due to its complex design (Bhattacherjee, 2012)
Generalizability issues - participants who volunteer may not represent general population accurately (Hariton & Locascio, 2018)
Often requires large sample sizes in various locations
Ethical issues: Due to ethics, certain RCTs cannot be performed (Yartev, 2017). Equipoise - need to weigh the risks versus potential benefits (Bhattacherjee, 2012)
Time consuming and costly (Hariton & Locascio, 2018)
Lengthy study; loss of follow up can occur, affecting the results as it can create bias in measures of association, and/or practices may have changed.
Selection bias can occur when the study groups are unmasked
Settings are highly controlled and have inclusion as well as exclusion criteria; therefore, real life situations may be different than study results
One of the most complex research designs there is, therefore is difficult to manage (Yartev, 2017)
Source of funding: strength or limitation?
Critically Appraising an RCT
Methodological Analysis: Randomized Controlled Trials for Pfizer and Moderna COVID-19 Vaccines
Summary: A critical appraisal utilizing RCT critical appraisal skills program for two RCT trials PFizer and Moderna. The goals for analysis are: first to enable health care providers to understand methods and outcomes of RCTs and second, to enable health care providers to become champions and reduce vaccine hesitancy (Hallas et al., 2021)