Azermai M, Petrovic M, Engelborghs S, et al. The effects of abrupt antipsychotic discontinuation in cognitively impaired older persons: A pilot study. Aging & Mental Health 2013;17:125-32
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/22928861
Full text article: https://www.tandfonline.com/doi/full/10.1080/13607863.2012.717255
| Methods | Study design: Before-and-after study
Number of groups: One group |
| Participants | Number of participants: 40 enrolled, 37 completed
Age: 84 years, range: 67 – 95 years Sex: 19 female, 21 male Dementia: · No confirmeddiagnosis of dementia, but cognitive impairment based on MMSE and behavioraldisturbances, n=6 · Diagnosed with dementia, n=34 o Alzheimer’s dementia – 55% o Vascular dementia – 15% o Dementia associated with Parkinson’s disease – 15% o No medical diagnosis of dementia (cognitive impaired) – 15%) · MMSE mean: 16, range: 4–25 · Activity of Daily Living physical dependency scores: 16 (range 6–24) Inclusion criteria: · Confirmed clinical diagnosis of dementia or cognitive impairment assessed by MMSE · Used antipsychotics explicitly for behavioral and psychological symptoms · Antipsychotic use was initiated before hospitalization (at home or in the nursing home) or (in the case of a long length of hospital stay) antipsychotics were used for at least one month during hospitalization · Treating physician and researchers agreed on behavioralstability of the patient Exclusion criteria: · None described Country: Belgium Setting: Hospital – across three hospitals |
| Interventions | Medicine: Antipsychotic
Median dose (dose range) % use · Atypical: 73% participants · Risperidone 1 mg (0.25–2): 48% of participants · Quetiapine 82 mg (50–100): 13% participants · Olanzapine 8% 5 mg (5–10): 8% participants · Clozapine: 4% participants Typical – 27% participants · Haloperidol 2 mg (1–5): 19 % participants · Others: 8% participants Withdrawal Schedule: Abrupt discontinuation |
| Outcomes | Successful deprescribing
Neuropsychiatric Index Possible Adverse Drug Withdrawal Effects |
| Dates | Study dates: March 2011 to November 2011
Follow-upduration: One month |
| Funding sources | Not stated |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | Non-randomized study design. |
| Allocation concealment (selection bias) | High risk | No concurrent control. |
| Blinding of participants and personnel (performance bias) | 5 out of 5 | Open study. |
| Blinding of outcome assessment (detection bias) | 5 out of 5 | Open study. |
| Incomplete outcome data (attrition bias) | 1 out of 5 | Outcome data reported, though the comparison group was those who had failed withdrawal to compare the characteristics of the participants who were successfully withdrawn to those who were not.
Only three patients aremissing and unlikely to affect results. The follow-up Neuropsychiatric Index scores after one month could only be obtained for 37 patients, since three patients had dropped out due to unrelated death (cancer and pneumonia; n¼2) or adverse event (i.e. fall 14 days after discontinuation; n¼1). |
| Selective reporting (reporting bias) | 2 out of 5 | All statedoutcomes reported upon, but no a priori published protocol available. |
| Confounding (non-randomized) | 5 out of 5 | The comparison group was those who had failed withdrawal to compare the characteristics of the participants who were successfully withdrawn to those who were not. |
| Other bias | Low risk | |
| Newcastle-Ottawa scale | ||
| Selection bias | Representativeness of the exposed cohort | Somewhat representative of the average person living with dementia who has behavioral and psychological symptoms of dementia. |
| Selection of the non-exposedcohort | No concurrent control group. | |
| Ascertainment of exposure | Ascertainment of exposure through securerecord. | |
| Demonstration that outcome of interest was not present at start of study | Demonstrated the outcome of interest was not present at the start of the study. | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | The studycontrols for antipsychotic use in hospitalized people living with dementia who have signs and symptoms of behavioraland psychological disturbances of dementia. |
| Outcome bias | Assessment of outcome
|
Assessment of outcome by record linkage. |
| Was follow-up long enough for outcomes to occur
|
Follow-up was probably sufficient for the follow-up to determine the behavioral and psychological effects once the antipsychotic was eliminatedfrom the system. Follow-up was probably not sufficient to determine if the intervention affected physical health and longevity (e.g. cerebrovascular accident). | |
| Adequacy of follow-up of cohorts | Completefollow-up – all subjects accounted for. | |