Horwitz GJ, Tariot PN, Mead K, et al. Discontinuation of antipsychotics in nursing home patients with dementia. American Journal of Geriatric Psychiatry 1995;3:290-99
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/28531062
| Methods | Study design: Comparative study with two-single arms
Number of groups: Three groups |
| Participants | Number of participants: 53 enrolled, 39 completed
· Intervention deprescribing group: 21 enrolled · Empirical deprescribing group: 26 enrolled · Group never taking antipsychotics: 6 enrolled Age: 82.7 years Sex: 44 female, 9 male Participants with dementia: All Inclusion criteria: · Dementia · Resident Exclusion criteria: · Not described Country: United States of America Setting: Residential aged care facility – 471-bed facility providing all levels of nursing home care with onsite attending internist for most patients and onsite psychiatric consultation service. |
| Interventions | Medicine: Typical antipsychotic
Withdrawal Schedule: Not described Comparison: Residents whose doctor considered they could stop antipsychotics, residents who were deprescribed without clinical judgment by their doctor, and those who were antipsychotic naive |
| Outcomes | Discontinued antipsychotic
MMSE Sandoz Clinical Assessment Geriatric scale Overt Aggression Scale Functional status measured by the Minimum Data Set Plus of the New York State Department of Health Psychotic symptoms as judged by a psychiatric nurse-specialist Quantified Neurological Exam Abnormal Involuntary Movement Scale |
| Dates | Dates: Not described
Follow-up duration: One year |
| Funding sources | New York State Department of Health, NIMH (MH-40381) and NIA (AG-08665) |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | Allocation by clinician judgment. Clinicians allocated to two active (deprescribing) groups and a control group. |
| Allocation concealment (selection bias) | High risk | Six participants who had never been prescribed antipsychotics were used to “mask” allocation. |
| Blinding of participants and personnel (performance bias) | 5 out of 5 | “A “comparison” group of six nursing home patients with dementia, not receiving antipsychotics, was observed longitudinally for 6 months in a detailed fashion similar to the second group. This group was used chiefly to help mask the design.” |
| Blinding of outcome assessment (detection bias) | 5 out of 5 | “assessments of behavior, function, neurologic status and cognition were performed by blind raters.”
Some blinding of personnel was attempted. Assessment was performed by different groups depending on the patient group. Blinded trained raters were used for two groups |
| Incomplete outcome data (attrition bias) | 5 out of 5 | One group assessed at 6 months and one at 12 months and then data combined. This data combination means that the data is not able to be meaningfully interpreted.
Drop-outs were not mentioned,and there was no way to assess completeness. I assume that all patients were followed-up but in rating for bias, the lack of discussion makes me rate a 4. |
| Selective reporting (reporting bias) | Unclear risk | Intended outcomes unclear, and data reported in a way that makes it difficult to interpret. |
| Confounding (non-randomized) | 5 out of 5 | This study has three groups. In one group, the investigators ceased the antipsychotic medicines. In the second group, the patient’s treating physician elected to withdraw the medicine. The third group was people who had never been prescribed an antipsychotic. Therefore, the groups were fundamentally imbalanced at baseline in such a way that the three groups are not comparable.
Because of the structure of the study groups, it is impossible to assess coverage of confounders. |
| Other bias | Low risk | |
| Newcastle-Ottawa scale | ||
| Selection bias | Representativeness of the exposed cohort | The participants were a selected group of users.
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| Selection of the non-exposed cohort | The control cohort was selected from a different population than the intervention cohort.
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| Ascertainment of exposure | Ascertainment of exposure was by secure record.
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| Demonstration that outcome of interest was not present at start of study | The researchers demonstrated that 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 | A factor controlled for by the study could not be adequately determined. |
| Outcome bias | Assessment of outcome | Outcome assessment was conducted independently. |
| Was follow-up long enough for outcomes to occur | Follow-up duration of one year is probably adequate.
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| Adequacy of follow-up of cohorts | No statement on adequacy of follow-up of participants. | |
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