The minimal clinically important difference of the Richmond Agitation‐Sedation Scale in patients with cancer with agitated delirium. Issue 10 (22nd February 2018)

• Record Type: Journal Article
• Authors: Hui, David; Hess, Kenneth; Dibaj, Seyedeh S.; Arthur, Joseph; Dev, Rony; Dalal, Shalini; Reddy, Suresh; Bruera, Eduardo
• Is Part Of: Cancer. Volume 124:Issue 10(2018)
• Page Start: 2246
• Page End: 2252
• Publication Date: 2018-02-22
• Subjects: delirium -- minimal clinically important difference -- neoplasms -- palliative care -- patient outcome assessment -- randomized controlled trial; Cancer -- Periodicals; Cancer -- Cytopathology -- Periodicals; 616.99405
• DOI: 10.1002/cncr.31312
• Languages: English
• ISSNs: 0008-543X

Abstract

Abstract : BACKGROUND: The Richmond Agitation‐Sedation Scale (RASS) is commonly used to assess psychomotor activity; however, to the authors' knowledge, its minimal clinically important difference (MCID) has not been determined to date. The objective of the current study was to identify the MCID for RASS using 2 anchor‐based approaches. METHODS: The current study was a secondary analysis of a randomized controlled trial to compare the effect of lorazepam versus placebo as an adjuvant to haloperidol for persistent agitation in patients with delirium. The primary outcome was change in RASS (10‐point numeric rating scale ranging from ‐5 [unarousable] to +4 [combative]) from baseline to 8 hours after treatment administration. The sensitivity‐specificity and within‐patient change methods were used to identify the MCID, with the anchor being patient comfort after the study intervention as perceived by caregivers and nurses. RESULTS: A total of 90 patients were randomized and 58 (64%) received the study medication for restlessness/agitation (mean baseline RASS, 1.6). A total of 23 caregivers (61%) and 23 nurses (55%) perceived that the patient was more comfortable after treatment. Using the sensitivity‐specificity method, the optimal RASS reduction was ≥4 points according to both caregivers (sensitivity of 61% and specificity of 80%; area under the curve, 0.71) and nurses (sensitivity of 73% and specificity of 84%; area under the curve, 0.78). The RASS cutoff value based on the within‐patient change method was similar (‐4.2 for caregivers and ‐4.0 for nurses). CONCLUSIONS: For patients with persistent restlessness/agitation, a reduction of ≥4 points in RASS was considered to be the MCID for both nurses and caregivers. These preliminary findings may have implications for sample size calculation and the interpretation of treatment effect in future delirium trials. Cancer 2018;124:2246‐52 . © 2018 American Cancer Society . Abstract : In this secondary analysis of a randomized clinical trial regarding patients with agitated delirium, the authors examine the minimal clinically important difference for the Richmond Agitation‐Sedation Scale using the sensitivity‐specificity and within‐patient change methods with the level of patient comfort as perceived by bedside nurses and caregivers as the anchors. Both methods appear to identify the optimal cutoff value for the Richmond Agitation‐Sedation Scale as a reduction of ≥4 points, which has potential implications for both patient care and research.