Core Outcome Measures in Effectiveness Trials

Are We Measuring What Really Counts?

General Information

Most published clinical research is faulty because of many reasons, one being faulty design. A remedy to this problem is the correct utilization of the PICOT (population, intervention, comparative intervention, outcome and time horizon) format in the design of a clinical research question. One element of the PICOT format, “outcome,” has not been assessed adequately in aesthetic surgery. In this review, we found that in the last decade of all randomized controlled trials and comparative studies published in Aesthetic Surgery Journal, only about half specified a primary outcome. Regrettably, only 40% reported both a primary outcome and justification for choosing this outcome. This poses a credibility issue with the conclusions of the majority of published studies. There is an urgent need to develop critical outcome sets for aesthetic procedures to be utilized by future investigators. With such a critical outcome set, we will be able to pool the results of multiple studies on the same subject and reach conclusive results.

Thoma, A. Hassan, Y. Santos, J.


Aesthetic Surgery Journal
777 - 785
Further Study Information

Funding source(s):
The authors received no financial support for the research, authorship, and publication of this article.

Health Area

Disease Category
Anaesthesia & pain control

Disease Name

Target Population

Age Range
18 - 100


Nature / type of Intervention


Systematic review

An electronic search of PubMed and the archive of the ASJ was performed to identify all RCTs or comparative studies published in the ASJ in the last decade (January 1, 2008 to September 1, 2018). This search was initially conducted in September 2018.

The search strategy included key words such as “randomized controlled trials,” “comparative studies,” “patient-reported outcomes,” and “outcome measures.” Please refer to Appendix A (available online as Supplementary Material at for the full search strategy.

All outcomes (definition of outcome: all the possible results that may stem from exposure to a therapeutic intervention; all the identified changes in health status arising as consequence of the handling of a health problem) were extracted from included trials and compiled into a summary list and classified as quantitative and/or subjective.

Stakeholders Involved


Study Type

Systematic review of outcome measures/measurement instruments
Systematic review of outcomes measured in trials

The site uses cookies, some may have been set already. Please refer to our privacy policy & cookie usage statement.
If you continue to use the site we'll assume you're happy to accept the cookies.