112 PART THREE | DELIRIUM Methods Patients Hospitalized patients with advanced cancer admitted to the medical oncology ward of six sites (1 university cancer center, 3 teaching hospitals, 2 high-care hospices) in the Netherlands were recruited between January 2011 through December 2015. Patients and/or their legal representatives were asked for informed consent to participate in this diagnostic study, as part of a randomized controlled trial (RCT), which compared the efficacy of haloperidol to olanzapine in case the patient was diagnosed with delirium (ClinicalTrials.gov identifier NCT01539733). The study was conducted according to Good Clinical Practice guidelines, the Declaration of Helsinki and local laws, and was approved by the institutional review boards of each participating study site. Patients with any type of cancer in an advanced stage, of 18 years and older who were fluent in the Dutch language were considered eligible. Patients with pre-existing cognitive impairment (such as Alzheimer’s disease), or psychiatric comorbidity that might hamper delirium diagnosis (e.g. schizophrenia) were excluded from this study. Also, patients using antipsychotic or neuroleptic medication for other reasons than neuropathic pain management were excluded. Additional exclusion criteria were based on contraindications for the use of haloperidol or olanzapine, like high risk at alcohol withdrawal delirium, glaucoma, Parkinson’s disease, QTc-interval prolongation >500msec at baseline ECG, a history of malignant neuroleptic syndrome and concomitant treatment with anticonvulsive drugs. Study Assessments Patients who were included in the trial were screened for delirium by their nurse using the DOS at the moment of admittance, and subsequently three times a day, biweekly during their stay in the hospital. Each DOS positive patient (DOS ≥ 3) was randomly matched with a DOS negative patient (DOS < 3) to evaluate the accuracy of the DOS. DOS positive patients and the randomly matched DOS negative patients were assessed with the Delirium Rating Scale-R-98 (DRS-R-98) by a trained independent assessor, who was blinded with regard to the DOS score of a patient. To prevent duplication bias patients were excluded from the DOS negative group if they were included in the randomised treatment part of the study during a later admission. DOS The original version, the DeliriumObservational Screening Scale (DOSS), consisted of a 25itemscale based on the DSM-IV criteria for delirium [17]. The scalewas designed to capture early symptoms of delirium that nurses could observe during regular care. The scale was subsequently reduced to 13 observations, and is known as the Delirium Observation Scale (DOS) [18]. Each item can be rated as normal (score, 0) or abnormal (score, 1). A total score of 3 or more points indicates delirium. Completion of the instrument requires less than 5 minutes. A small descriptive study evaluated the DOS in patients admitted to a palliative care unit [23]. The DOS was compared to the CAM and the Delirium Index and showed good psychometric properties. Moreover, it was experienced as user-friendly by the bedside nurses. Internal consistency, predictive validity, and concurrent and construct
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