Blinding : the process of preventing one or more of patients, clinicians, investigators, and data analysts from knowing whether individual patients are receiving the investigational intervention(s) or the control (or standard) intervention(s) in a clinical trial. (Also known as masking.) Blinding is intended to eliminate the possibility that knowledge of which intervention is being received will affect patient outcomes, investigator behaviors that may affect outcomes, or assessment of outcomes. Blinding is not always practical (. when comparing surgery to drug treatment), but it should be used whenever it is possible and compatible with optimal patient care. The terms “single-blinded,” “double-blinded,” and “triple-blinded” refer to which parties are blinded, ., one or more of patients, investigators, and data analysts; however, these terms are used inconsistently and the specific parties who are blinded in a trial should be identified.
Comparison or control conditions may include treatment-as-usual or other standard or experimental interventions of proven efficacy. However, placebo or sham interventions might be used where appropriately justified, for example, in studies of augmentation strategies (blinded) added to existing treatments (generally open-label). In contrast to efficacy trials, it is anticipated that effectiveness trials might not be double-blind; while self- and clinician-ratings can be informative and may reasonably be collected, unless otherwise justified, raters responsible for key outcome measures should be blinded as to subjects’ treatment assignment. Primary outcome measures should be validated and generally accepted by the field. Given the emphasis on practice relevant questions, outcomes of interest extend beyond symptom reduction to include short- and long-term assessment of changes in functioning across domains (such as school, work, family, peer functioning) for children, adolescents, and adults, and also might include other outcomes of interest to key stakeholders (., efficiency, value, or other factors related to the eventual implementation of new intervention and services approaches).
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