Negative results from a randomized controlled trial of olanzapine for psychosis in Parkinson disease: data, CONSORT checklist and initial study protocol

CONSORT checklist
Subject characteristics at study entry: S#, subject ID for this study; DRUG, olanzapine dose (mg) this patient took; ADJUST, whether the dose of antiparkinsonian medication was adjusted at the week 2 visit. For remaining columns, the trailing zero in the column heading refers to the score at the baseline (week 0) visit; see Methods section for references. BPRST, BPRS total score; BPRSP, BPRS psychosis items subscore; PDQ, PDQ39 score; BDI, Beck Depression Inventory; HamD, Hamilton Depression Rating Scale; CGIMDo/a, Clinical Global Impression score for overall clinical state as rated by investigator; INS, insomnia score from sleep rating scale; HYPIN, hypersomnia score from sleep rating scale; SEADLS, Schwab-England score; BlindKB, investigator guess at week 4 as to drug assignment; BlindPt., patient guess at week 4 as to drug assignment.
Outcomes other than blinded BPRS ratings: S#, subject ID for this study; DRUG, olanzapine dose (mg) this patient took; ADJUST, whether the dose of antiparkinsonian medication was adjusted at the week 2 visit; change, details of that change; use0-2, analyze this subject’s data in the ANOVA for weeks 0-2; use2-4, analyze this subject’s data in the ANOVA for weeks 2-4; WD, ended study participation early; WDSE, withdrew from study because of side effects; WDnowork, withdrew from study because of lack of benefit; WDcure, withdrew from study because subject pronounced self “cured” after one dose; SAEs, serious adverse events; mild SEs, mild side effects; other, other comments on efficacy or side effects; handed, right- or left-handed. For remaining columns, the trailing numeral in the column heading refers to the score at the visit from week 0, 2, or 4. See Methods section for additional information. VH, visual hallucinations present; AH, auditory hallucinations present; Del, delusions present; BPRST, BPRS total score; BPRSP, BPRS psychosis items subscore; 1UPDRS, UPDRS subscale 1; 2UPDRS, UPDRS subscale 2 (etc.); PDQ, PDQ39 score; BDI, Beck Depression Inventory; HamD, Hamilton Depression Rating Scale; CGI, Clinical Global Impression scale; CGIMD, CGI rated by investigator; CGI…overall, CGI score for overall clinical state; CGIPT, CGI rated by patient; CGI…hall, CGI for hallucinations; CGI…improve, CGI improvement from study initiation; INS, insomnia score from sleep rating scale; BlindJH, study RN guess at week 4 as to drug assignment; BlindKB, investigator guess at week 4 as to drug assignment; BlindKBdrug, same, collapsed to simply olanzapine vs placebo (no dose category); BlindPt., patient guess at week 4 as to drug assignment; BlindBR, guess of study neurologist at week 4 as to drug assignment; 0/5/10, whether this subject was enrolled under the initial study drug assignment (placebo vs 5 or 10mg); HYPIN, hypersomnia score from sleep rating scale; SEADLS, Schwab-England score.
Blinded BPRS ratings from videotape: video ID#, code by which blinded videotape reviewer scored each video segment; BPRS-T, BPRS total score; BPRS-P, BPRS psychosis items subscore.

CONSORT 检查清单
研究入组受试者特征：S#，本研究受试者编号；DRUG，患者所服用的奥氮平剂量（mg）；ADJUST，是否在第二周访视时调整了抗帕金森病药物剂量。对于剩余的列，列标题末尾的零表示基线（第0周）访视的评分；详见方法部分以获取参考文献。BPRST，BPRS 总评分；BPRSP，BPRS 精神病项目子评分；PDQ，PDQ39 评分；BDI，贝克抑郁量表；HamD，汉密尔顿抑郁评定量表；CGIMDo/a，由研究者评估的整体临床状态的临床总体印象评分；INS，睡眠评分量表中的失眠评分；HYPIN，睡眠评分量表中的嗜睡评分；SEADLS，Schwab-England 评分；BlindKB，研究护士在第四周对药物分配的猜测；BlindPt.，患者在第四周对药物分配的猜测。
除盲化的 BPRS 评分以外的结果：S#，本研究受试者编号；DRUG，患者所服用的奥氮平剂量（mg）；ADJUST，是否在第二周访视时调整了抗帕金森病药物剂量；change，变化的详细情况；use0-2，在 0-2 周的方差分析中分析该受试者的数据；use2-4，在 2-4 周的方差分析中分析该受试者的数据；WD，提前结束研究参与；WDSE，因副作用退出研究；WDnowork，因缺乏疗效而退出研究；WDcure，因受试者在服用一次剂量后声称自己已“治愈”而退出研究；SAEs，严重不良事件；mild SEs，轻微副作用；other，关于疗效或副作用的其它评论；handed，左右手。对于剩余的列，列标题末尾的数字表示从第0周、第2周或第4周的访视评分。详见方法部分以获取更多信息。VH，存在视觉幻觉；AH，存在听觉幻觉；Del，存在妄想；BPRST，BPRS 总评分；BPRSP，BPRS 精神病项目子评分；1UPDRS，UPDRS 子量表 1；2UPDRS，UPDRS 子量表 2（等）；PDQ，PDQ39 评分；BDI，贝克抑郁量表；HamD，汉密尔顿抑郁评定量表；CGI，临床总体印象量表；CGIMD，由研究者评估的 CGI；CGI…overall，整体临床状态的 CGI 评分；CGIPT，由患者评估的 CGI；CGI…hall，幻觉的 CGI；CGI…improve，从研究开始以来的 CGI 改善；INS，睡眠评分量表中的失眠评分；BlindJH，研究护士在第四周对药物分配的猜测；BlindKB，研究者在第四周对药物分配的猜测；BlindKBdrug，相同，合并为奥氮平与安慰剂（无剂量类别）；BlindPt.，患者在第四周对药物分配的猜测；BlindBR，研究神经科医生在第四周对药物分配的猜测；0/5/10，该受试者是否在初始研究药物分配下（安慰剂 vs 5 或 10mg）入组；HYPIN，睡眠评分量表中的嗜睡评分；SEADLS，Schwab-England 评分。
来自录像带的盲化 BPRS 评分：video ID#，盲化录像带评分员对每个视频片段进行评分的代码；BPRS-T，BPRS 总评分；BPRS-P，BPRS 精神病项目子评分。