Sham Controls in Evaluating Cardiac Procedures: A Pilot Systematic Review of RCTs

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  • April 7, 2020
Creator
  • Yang, Yi
    • Affiliation: Gillings School of Global Public Health, Public Health Leadership Program
Abstract
  • Background: Blinding minimizes measurement bias, particularly when the outcome being assessed is patient-reported, since psychological measures of well-being and symptoms are influenced by expectations of the effectiveness of a treatment, which can come either from aspects of the intervention or from physician communication. Blinding of investigators collecting patient reported outcomes may be easy, but in surgery, blinding of the participant is impossible without a procedural control. A sham procedural control allows for participant blinding and serves to mimic the psychosocial context a patient will experience, which accounts for the placebo effect before analysis. Purpose: To investigate the use and reporting of sham procedural controls in cardiac procedural randomized controlled trials (RCTs) assessing patient-reported outcomes. Data Sources: Cardiac RCTs published in The Lancet and The New England Journal of Medicine from 1/2005 to 1/2016. Study Selection: RCTs of adults (1) investigating an intervention that involved an invasive procedure for treating a cardiac disease, (2) with the potential to use a sham control, and (3) reporting patient-reported outcomes. Data Extraction: A single reviewer extracted data from the full-text. Data Synthesis: Of the 11 studies that could have used a sham procedural control, only 1 used a sham control and blinded both participants and research assessors to intervention group randomization. The remaining 10/11 surgery studies that assessed quality of life outcomes did not blind patients to their intervention group, leading to a high risk of measurement bias. Limitations: Identification of published cardiac surgery RCTs was limited to two journals. A single reviewer completed all abstract reviews, full-text reviews, and data extraction. Conclusions: Surgical research investigating the effect of a procedural intervention on patient-reported outcomes often do not use the ideal of a sham procedural control and often do not provide sufficient reporting about methods of collecting the patient reported outcome or the blinding status of the research assessor. The challenges of incorporating sham procedural controls in surgical studies include obtaining IRB approval, risk of low study enrollment, increased study costs, or fear of unavoidable ethical concerns. Nevertheless, these problems in weighing the benefits and risk of a study are not unique to surgical study design. More surgical studies that evaluate cardiac procedures using patient-reported outcomes should use sham controls to improve study result validity. Funding: There is no funding or sponsor associated with this study.
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  • In Copyright
Note
  • Paper type: Systematic review
  • Track: HC&P
Advisor
  • Harris, Russell
Reviewer
  • Saver, Richard
Degree
  • Master of Public Health
Degree granting institution
  • University of North Carolina at Chapel Hill
Graduation year
  • 2016
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  • 133182e3-a0b2-47ad-b991-2a7baaf1b933

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