Yeh YC, Liu CL, Peng LN, et al. Potential benefits of reducing medication-related anticholinergic burden for demented older adults: A prospective cohort study. Geriatrics & Gerontology International 2013;13:694-700
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/23216534
Full text article: https://onlinelibrary.wiley.com/doi/full/10.1111/ggi.12000
| Methods | Study design: Prospective cohort study
Number of groups: Two groups |
| Participants | Number of participants: 67 enrolled, 53 completed
· Intervention deprescribing group: 40 enrolled, 32 completed · Control group: 27 enrolled, 21 completed Age: 83.4 ± 4.4 years Sex: 0 females, 40 males Participants with dementia: Yes (diagnosis of dementia was confirmed by neurologists based on the DSM-IV criteria) · Baseline MMSE: 9.2 ± 6.5 · Baseline Modified Barthel Index: 73.0 ± 18.1 Inclusion criteria: · Diagnosis of dementia was confirmed by neurologists based on the DSM-IV criteria Exclusion criteria: · Primary diagnosis of major psychotic disorder · Mental retardation · Recent aggravation of behavioral and psychological symptoms of dementia · Recent major deterioration in health status · Short life expectancy Concomitant medicines: 4.6 ± 2.3 Country: Taiwan Setting: Residential aged care facility (dementia care unit of a Veteran Home (which is similar to the retirement communities) |
| Interventions | Medicine:
· Antipsychotics n=29, 76%: risperidone, quetiapine · Antidepressants n=19, 50%: fluvoxamine, trazodone, paroxetine, sertraline, fluoxetine, doxepin · Beta-blockers 3 (8%): atenolol · Benzodiazepine 1 (3%): alprazolam Withdrawal schedule: Slowly tapered off or switched to alternatives with lower anticholinergic burden according to the recommendations from the research team Education program Trainer: Investigators (doctors) Trainee: Primary care physicians at the aged care facilities Training material: “designed to reduce the overall use of anticholinergic medications by improving the selection of their use” Training duration: Educational material delivered by mail Tool to identify deprescribing targets: Clinician-Rated Anticholinergic Score (CR-ACHS) and pre-specified list of target medications |
| Outcomes | Clinician-Rated Anticholinergic Score
MMSE Modified Barthel Index Hospital admissions |
| Dates | Dates: Not described
Duration: 12 weeks |
| Funding sources | Veteran Affairs Commission, Executive Yuan, Republic of China (Taiwan) |
| Notes | Declared conflicts of interest: “All authors declare no financial support or relationship that may pose conflicts of interest.” |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | Assigned by ability to adhere to the research protocol.
Case-control design. ” Residents were assigned to the intervention group if the primary care team could adhere to the research protocol and the remaining residents were assigned to the reference group receiving conventional care.” |
| Allocation concealment (selection bias) | High risk | Open trial. |
| Blinding of participants and personnel (performance bias) | 5 out of 5 | Open trial. |
| Blinding of outcome assessment (detection bias) | 5 out of 5 | Open trial. |
| Incomplete outcome data (attrition bias) | 5 out of 5 | 14 (20.9%) participants had been hospitalized, so they were withdrawn from the interventional program Hospitalization reasons were given, and some could have been related to the intervention.Participants were withdrawn if hospitalized. As this could conceivably be related to the intervention, this increases a high risk of bias. |
| Selective reporting (reporting bias) | 2 out of 5 | The primary outcome of the present study was anticholinergic burden. Other clinical outcomes including cognitive and functional status of each participant were also assessed. The safety of reducing anticholinergic burden was evaluated by subsequent hospital admissions and mortality. These were all reported.No pre-published protocol available, however, the reported outcomes are similar to the stated objectives.14 (20.9%) participants had been hospitalized, so they were withdrawn from the interventional program. |
| Confounding (non-randomized) | 5 out of 5 | Residents were assigned to the intervention group if their primary care team consented to adhere to the research protocol and the remaining residents were assigned to the control group.No measure of total anticholinergic load taken, procholinergic drugs not considered. |
| Other bias | High risk | The list of anticholinergic drugs includes risperidone, which has virtually no anticholinergic potential. This brings into doubt the validity of the educational program. It is not clear whether the educational program was being tested or the intervention of withdrawing anticholinergics. Since both interventions were run together, the methodology cannot distinguish between effects.The study relied on the general practitioner of the participant to implement changes based on the researcher-provided educational material and patient information. It is not clear as to what extent the reliance on the general practitioner to implement change affected the outcomes, as this means it was also reliant on his judgment of his patient.”The experimental general practitioner received our educational messages by mail, which presented medication-related anticholinergic adverse effects, categorical summaries of anticholinergic drugs in the literature, the Clinician-Rated Anticholinergic Score, baseline medication use and total Clinician-Rated Anticholinergic Score of each resident, and the proposed alternatives.” |
| Newcastle-Ottawa scale | ||
| Selection bias | Representativeness of the exposed cohort | Selected group of users. |
| Selection of the non-exposed cohort | The selection of the concurrent control group was drawn from those residents whose primary care team did not consent to their participation. Therefore, there is a strong possibility of a significant difference between them. | |
| Ascertainment of exposure | Ascertainment of exposure was by secure record. | |
| Demonstration that outcome of interest was not present at start of study | They demonstrated that the drug was present at the start of the intervention period. | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | The study controlled for reduction in anticholinergic load. |
| Outcome bias | Assessment of outcome | Assessment of outcome was by record linkage. |
| Was follow-up long enough for outcomes to occur | Follow-up was probably long enough for outcomes of interest to occur. | |
| Adequacy of follow-up of cohorts | Follow-up rate 79.1% but no description of those lost | |
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