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. 2020 Jan 21;2020(1):CD004770. doi: 10.1002/14651858.CD004770.pub3

Lin 2008.

Methods Randomized clinical trial, single‐site, open trial, parallel groups
Study duration: 1 week from baseline assessment
Location: Taiwan
Participants Total: 30 patients
Setting: hospice and palliative care centre at a large general and teaching hospital
Mean age years (SD): olanzapine 61 years (16.50); haloperidol 68 years (12.14)
Gender no. (% female): olanzapine 7 (44%); haloperidol 10 (71%)
Diagnosis (%): 100% cancer
Delirium severity: baseline delirium severity was assessed by the Delirium Rating Scale (Chinese version). DRS (Chinese) scores could range from 10 to 33 with higher scores indicating greater severity. Mean and standard deviations scores were: 17.56 (SD = 5.18) in the olanzapine group and 16.50 (SD = 4.70) in the haloperidol group
Performance status: not assessed.
Inclusion criteria: patients with advanced cancer requiring hospice and palliative care; diagnosis of delirium as per the DSM‐IV
Exclusion criteria: past history of psychiatric disorders; coma, inability to swallow oral medication, treatment with neuroleptic agents within 4 weeks prior to the enrolment
Interventions Intervention: olanzapine starting dose 5 mg per day ‒ oral. n = 16
Comparison: haloperidol starting dose 5 mg per day ‒ oral. n = 14
If the participant's condition did not improve doses were titrated up to a maximum daily dose of 15 mg olanzapine or 15 mg haloperidol. Midazolam by intramuscular injection was available when rescue medication was required
Timing of treatment: commenced at 6 p.m. on day 1 with doses administered every 24 hours
Treatment duration: 1 week
Outcomes Outcomes (primary and secondary outcomes undifferentiated):
  • Delirium severity assessed by the Chinese version of the Delirium Rating Scale (DRS‐c). Scores ranged from 0 to 33 (in contrast to 0 to 32 for the English DRS).

  • Treatment response assessed by the Clinical Global Impression Severity (CGI‐S) scale. The CGI is a 3‐item scale used to assess treatment response in psychiatric patients ‒ severity of illness, global improvement, and efficacy index. The CGI‐S is one of CGI items assessing illness severity with scores ranging from 1 (normal) to 7 (extremely ill).

Notes No information on funding or conflicts of interest provided
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "If the patients needed to have antipsychotic, they were separated randomly to an olanzapine group or a haloperidol group"
Comment: no information provided on how participants were randomised
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Incomplete blinding ‒ assessor was blinded to the treatment received by each participant but participants were unblinded. However, participant unblinding is unlikely to have an effect on the outcome
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "The assessor was blind to what kind of antipsychotic the patients received when she assessed the following DRS‐C and CGI‐S and the side effect of both groups cross time periods"
Incomplete outcome data (attrition bias) 
 All outcomes High risk High rates of dropout. 11/16 (67%) dropped out in the olanzapine group and 7/14 (50%) dropped out in the haloperidol group. No reasons given and no information provided on handling of missing data. Low number of participants completed study
Selective reporting (reporting bias) Unclear risk Protocol not available. Insufficient information to judge selective reporting bias
Sample size High risk Fewer than 50 participants per arm

DRS: Delirium Rating Scale
 DSM‐III‐R: Diagnostic and Statistical Manual of Mental Disorders III (revision)
 DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders III (revision)
 IQR: Interquartile range
 mg: milligram
 mg/d: milligrams per day
 ml: millilitre
 MMSE: Mini‐Mental State Examination
 n: Sample size
 QT interval: measurement made on an electrocardiogram used to assess some of the electrical properties of the heart. It is calculated as the time from the start of the Q wave to the end of the T wave and approximates to the time taken from when the cardiac ventricles start to contract to when they finish relaxing.
 SD: standard deviation