A phase III randomised, double-blind placebo controlled study to compare the effectiveness of oral Risperidone and oral Haloperidol in the management of delirium

Dataset includes: - Two hundred forty-seven participants were included in intention-to-treat analysis (82 receiving risperidone, 81 receiving haloperidol, and 84 receiving placebo. Treatment period over 72 hours while inpatient, with follow-up for 4 weeks post treatment where possible. Data available for demographic, medical history data, concurrent medications, and baseline clinical measures. Primary outcome data measured by as Nursing Delirium Screening Scale (items 2, 3 and 4), safety and toxicity data measured using the NCI CTCAE V3.0, Extrapyramidal symptom rating scale (ESRS), and sedation subscale of Richmond Agitation Sedation scale. Other data for secondary analysis include; Australia-modified Karnofsky Performance Status (measured at baseline, treatment cessation and end of follow-up), Mini Mental Status Examination (measured at baseline, treatment cessation and discharge from hospital), pulse oximetry (measured at baseline, and daily during intervention), Cumulative Illness Rating Scale (measured at baseline and delirium resolution), sedation (measured at baseline and daily during intervention), Nursing Delirium Screening Scale (measured at baseline and each shift during intervention), the Memorial Delirium Assessment Scale (measured at baseline, daily, delirium resolution, IQCODE for caregivers (measured at baseline), Distress for Nurses, caregivers (measured at baseline, treatment cessation or delirium resolution) and patients (measured at delirium resolution and week 4 follow-up), nursing hours of care, and health care utilisation.

本数据集涵盖如下内容：意向性治疗分析（intention-to-treat analysis）共纳入247名受试者，其中利培酮（risperidone）组82例、氟哌啶醇（haloperidol）组81例、安慰剂组84例。受试者住院治疗周期超过72小时，若条件允许则在治疗结束后开展为期4周的随访。数据集包含人口统计学资料、病史记录、合并用药情况以及基线临床测量数据。
主要结局指标采用护理谵妄筛查量表（Nursing Delirium Screening Scale）的第2、3、4项进行评估；安全性与毒性数据通过美国国家癌症研究所常见不良反应事件评价标准3.0版（NCI CTCAE V3.0）、锥体外系症状评定量表（Extrapyramidal symptom rating scale, ESRS）以及里奇蒙德激越镇静量表（Richmond Agitation Sedation scale）的镇静子量表进行采集。
用于二级分析的其他数据包括：澳大利亚改良卡氏功能状态量表（Australia-modified Karnofsky Performance Status，分别于基线、治疗结束及随访终点时测量）、简易精神状态检查（Mini Mental Status Examination，分别于基线、治疗结束及出院时测量）、脉搏血氧饱和度（于基线及干预期间每日测量）、累积疾病评定量表（Cumulative Illness Rating Scale，分别于基线及谵妄缓解时测量）、镇静状态（于基线及干预期间每日测量）、护理谵妄筛查量表（于基线及干预期间每班测量）、纪念谵妄评定量表（Memorial Delirium Assessment Scale，分别于基线、每日、谵妄缓解时测量）、照顾者智力功能简易问卷（IQCODE for caregivers，于基线时测量）、护士与照顾者苦恼评分（于基线、治疗结束或谵妄缓解时测量）以及患者苦恼评分（于谵妄缓解及第4周随访时测量）、护理工时及医疗资源利用情况。