Development of the Physical Restraint Decision-Making Assessment Instrument: A Validation Study.

OBJECTIVES: The use of physical restraints is a common practice in acute-care hospitals. Nonetheless, physical restraints are associated with adverse patient outcomes and ethical dilemmas. Currently, a comprehensive evidence-based instrument that can guide nurses through the complex decision-making process concerning the use of physical restraints is lacking. This study aimed to develop and validate the Physical Restraint Decision-Making Assessment Instrument to support and standardize nurses' decision-making regarding the use of physical restraints in acute-care settings. METHODS: Instrument items were developed through a systematic review of the existing literature and interviews with stakeholder focus groups. A 2-round Delphi technique involving 5 multidisciplinary experts was used to establish content validity, which was assessed using the content validity index (CVI) and modified kappa coefficient (k*). Subsequently, 10 clinical teaching nurses evaluated face validity using the face validity index (FVI). Finally, 3 nurses independently assessed 30 patients to determine inter-rater reliability, with agreement measured using Fleiss' kappa. RESULTS: The Delphi process refined an initial set of 36 items into a final 31-item instrument. This tool showed excellent content validity (scale-level CVI [S-CVI/Ave] of 0.99 for relevance and 0.99 for clarity) and satisfactory face validity (scale-level FVI [S-FVI/Ave] of 0.90). The inter-rater reliability was almost perfect, with Fleiss' kappa value of 0.822 (P<0.001). CONCLUSIONS: The instrument demonstrates strong psychometric properties and shows promise as a structured tool to support and standardize the complex decision-making process for applying physical restraints. Clinical effectiveness and impact on restraint rates and patient outcomes require confirmation through the planned randomized controlled trial before routine implementation is recommended.