Somani Salma. Dyskinesias Secondary to Gradual Neuroleptic Drug Withdrawal in Elderly Nursing Home Residents. Journal of Geriatric Drug Therapy 1996;11(1):37-51.
| Methods | Study design: Non-randomized experimental study with a parallel design
Number of groups: Two groups |
| Participants | Number of participants: 57 enrolled
· Intervention deprescribing group: 17 enrolled · Control group: 40 enrolled Age: 85 ± 7 years Sex: 43 females, 14 males Other medicines: The addition of non-neuroleptic psychotropic medicines to manage behavioral problems, or drugs that could mask movement disorders was discouraged. Only 4% took anticholinergic medicine Participants with dementia: 95% Median baseline MMSE score was 9 · 2% – no impairment (MMSE score 24-30) · 12% – mild impairment (MMSE score 18-23) · 18% – severe impairment (MMSE score 0-17) Inclusion criteria · 65 years and over · Stable neuroleptic dose for at least 90 days for the management of behavioral disorders due to dementia Exclusion criteria: · Unstable behavioral condition at baseline · “As needed” neuroleptic use only · diagnoses of Parkinson’s disease · Huntington’s chorea · Wilson’s disease · Other diseases associated with movement disorders · Diagnosis of schizophrenia · Use of beta-blockers or long-acting benzodiazepines (short-acting benzodiazepine hypnotics were acceptable) · Behavioral relapse in experimental group subjects, necessitating reinstitution of the baseline neuroleptic dosage during the study period Country: United States of America Setting: Residential aged care facilities – 37 in metropolitan Minnesota |
| Interventions | Medicine: Antipsychotics (e.g. haloperidol, loxapine, chlorpromazine)
· Duration of pre-study use 28 ± 30 months (range 3 to 165 months, median 20 months) · Baseline antipsychotic dose (stated in chlorpromazine equivalence): 68 ± 77 mg (range 11 to 500 mg, median 50mg) Withdrawal schedule: Tapered at a rate of 25 percent of the daily dose each month for four months (based upon the availability of suitable dosage forms) with a goal of discontinuation after a maximum of four months. Comparator: Usual care |
| Outcomes | Dyskinesias
· Severity · Withdrawal dyskinesias – presence · Withdrawal dyskinesias – reversibility Behavioral relapse Falls Adverse drug withdrawal events Successful deprescribing |
| Dates | Dates: November 1991 start
Follow-up duration: Eight months |
| Funding sources | Geriatric Drug Therapy Research Institute, American Society of Consultant Pharmacists |
| Notes | MMSE measured at baseline and study end but change is not reported. |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | Residents were assigned to groups by physician decision – not randomized.
Group allocation was performed as a joint decision of the attending physician and the physician co-investigator. “prospective non-randomized” “… residents assigned to the group … “ |
| Allocation concealment (selection bias) | High risk | Not blinded
“Prospective non-randomized single-blind…” “… residents assigned to the group … “ |
| Blinding of participants and personnel (performance bias) | 5 out of 5. | Not blinded |
| Blinding of outcome assessment (detection bias) | 1 out of 5. | Study says it is single blind. However, method to blind the outcome assessors is not described.
Assessment was performed by 2 trained nurse clinicians who were blinded to group assignment and had no access to medical records |
| Incomplete outcome data (attrition bias) | Unclear risk | no missing data reported but it was unclear as to whether there were any dropouts or all completed the study.
No dropouts reported. However, the exclusion criteria “behavioral relapse in experimental group subjects, necessitating reinstitution of the baseline neuroleptic dosage during the study period” suggests that dropouts may have been recorded as exclusions. |
| Selective reporting (reporting bias) | 5 out of 5. | The researchers probably had a pre-specified protocol and analysis plan.
Dyskinesia assessment was the only pre-specified criteria in the method and was reported. Measures of behavioral relapse were taken but were not pre-specified. MMSE was measured at baseline but never again so it could not be used as a measure of outcome |
| Confounding (Non-randomized) | 5 out of 5. | Method considers important confounders – other movement disorders and type of antipsychotic. However the criteria for choosing groups are not stated and is a major confounder. |
| Other bias | Low risk | Limited detail to make further assessment. |
| Newcastle-Ottawa Scale | ||
| Selection bias | Representativeness of the exposed cohort | Somewhat representative of inpatient older adults with dementia taking regular neuroleptics. |
| Selection of the non exposed cohort | Concurrent control group drawn from the same residential aged care facility as the exposed cohort. | |
| Ascertainment of exposure | Ascertainment of exposure by structured interview. | |
| Demonstration that outcome of interest was not present at start of study | Demonstration that outcome of interest was not present at start of study. | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | Study controls for neuroleptic cessation. |
| Outcome bias | Assessment of outcome | Outcome assessment by independent blind assessment. |
| Was follow-up long enough for outcomes to occur | Follow-up was long enough for outcomes to occur. | |
| Adequacy of follow up of cohorts | No statement about adequacy of follow-up. | |
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