Salonoja M, Salminen M, Vahlberg T, et al. Withdrawal of psychotropic drugs decreases the risk of falls requiring treatment. Archives of Gerontology and Geriatrics 2012;54:160-67.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/21420744
| Methods | Study design: Non-randomized controlled study as a subset of a randomized controlled trial with a two-by-two-factorial design
Number of groups: Nine groups |
| Participants | Number of participants: 591 enrolled, 179 completed
· Falls-risk increasing medicines-taking participants 1. Intervention deprescribing group and multifactorial intervention group: 29 participants* 2. Continued medicine and multifactorial intervention group: 89 participants 3. Usual care group: 104 participants* · Psychotropic medicines-taking participants 1. Intervention deprescribing group and multifactorial intervention group: 31 participants* 2. Continued medicine and multifactorial intervention group: 78 participants 3. Usual care group: 93 participants* · Benzodiazepine-taking participants 1. Intervention deprescribing group and multifactorial intervention group: 35 participants* 2. Continued medicine and multifactorial intervention group: 63 participants 3. Usual care group: 81 participants* Age: · 72.7 ± 4.2 years (active deprescribing group one – falls-risk increasing medicines) · 73.5 ± 5.0 years (active deprescribing group two – psychotropic medicines) · 72.5 ± 4.8 years (active deprescribing group three – benzodiazepines) Sex: 538 female, 66 male Participants with dementia: No Inclusion criteria: · 65 years or over · Living in the town of Pori · One or more self-reported falls in the previous 12 months · Ability to walk independently at least 10 meter with or without walking aids · Normal cognitive functioning or only mild dementia, MMSE score ⋟17 · Living at home or in an assisted-living facility Exclusion criteria: · None described Concurrent medicines: 391 people take four or more medicines regularly Country: Finland Setting: Community |
| Interventions | Medicine:
· Withdrawal group one: Falls-risk increasing medicines – labelled up by Anatomical Therapeutical Chemical (ATC) code. In particular: opioids, benzodiazepines, anticholinergic, antidepressants, and antipsychotics · Withdrawal group two: Psychotropic medications (specified as antidepressives (ATC codes N06A and N06CA01), antipsychotics (N05A), benzodiazepines/benzodiazepine-RDs (A03CA, N03AE01, N05BA, N05CD, N05CF, N06CA01, R06AE53, and M09AA72) and buspirone (N05BE01)) · Withdrawal group three: benzodiazepines A03CA, N03AE01, N05BA, N05CD, N05CF, N06CA01, R06AE53, and M09AA72 Withdrawal schedule: Geriatrician provided plans to users to gradually reduce these medicines as a step-wise procedure over some months Comparator: Deprescribing and the multifactorial falls-prevention intervention (geriatric assessment, counselling, physical exercise education, home safety assessment and advice), compared to the multifactorial falls-prevention intervention with continued medicine use, compared to usual care. Method to identify targets: Patient-specific intervention: investigator-led intervention: Intervention by geriatrician who initiated drug withdrawal, and provided participants with a withdrawal schedule to implement. Tool to identify deprescribing targets: Three pre-specified lists of target medications |
| Outcomes | Number of falls in total (i.e. one person may have had one or more falls, so can contribute more than once)
Number of people falling (i.e. just if the person has fallen at least once) Risk of a fall that required medical treatment (regression – deprescribing group is reference group) |
| Dates | Dates: February 2003 to February 2005
Follow-up duration: Four years |
| Funding sources | Satakunta Hospital District, Academy of Finland, Miina Sillanpa¨a¨ Foundation, Varsinais-Suomi Hospital District, Paivikki and Sakari Sohlberg Foundation, and Juho Vainio Foundation. The funding sources had no further role in the study design, collection of data, analyses and interpretation of data, writing of the report, or in the decision to submit the paper |
| Notes | * The deprescribing group and the usual care groups were combined for the analysis.
Numbers do not add up in descriptions Authors stated: “Conflict of interest statement: None.” |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | This study is a non-randomized, controlled sub-analysis of a randomized, controlled multifactorial fall prevention intervention Groups for this sub-analysis were formed retrospectively from the data of the original randomized, controlled study. |
| Allocation concealment (selection bias) | High risk | Groups for this sub-analysis were formed retrospectively from the data of the original randomized, controlled study. |
| Blinding of participants and personnel (performance bias) | 1 out of 5 | Groups for this sub-analysis were formed retrospectively from the data of the original randomized, controlled study. Thereforeparticipants were blinded in original study but personnel and assessors were not. |
| Blinding of outcome assessment (detection bias) | 5 out of 5 | As above |
| Incomplete outcome data (attrition bias) | 5 out of 5 | It is impossible to evaluate as they seem to have made groups labeled as falls-risk increasing drugs, psychotropic,and benzodiazepine but included users of multiple drugs in each group.
Numbers do not add up in descriptions. For examplethe numbers across each of the nine groups add up to more than the number of people randomized. |
| Selective reporting (reporting bias) | Unclear risk | It is impossible to evaluate as they seem to have made groups labeled as falls-risk increasing drugs, Psychotropicand benzodiazepine but included users of multiple drugs in each group.
Specified outcome measures reported |
| Confounding (non-randomized) | 5 out of 5 | The original study was a multifactorial study, which is a major confounder itself if you are trying to retrospectively create a deprescribing study.
The multiple interventions (lifestyle, education) and deprescribing confound the potential outcomes when considered as a deprescribing study alone rather than a multifactorial intervention. |
| Other bias | Low risk | |
| Newcastle-Ottawa scale | ||
| Selection bias | Representativeness of the exposed cohort | Somewhat representative of the average older adult at risk of repeated falls in the community. |
| Selection of the non-exposed cohort | The concurrent controls were drawn from the same community as the exposed group | |
| Ascertainment of exposure | Ascertainment of exposure was by secure record. | |
| Demonstration that outcome of interest was not present at start of study | Yes | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | The study controlled for lifestyle modification and deprescribing together |
| Outcome bias | Assessment of outcome | Assessment of outcome: record linkage |
| Was follow-up long enough for outcomes to occur
|
Follow-up was long enough for outcomes to occur | |
| Adequacy of follow-up of cohorts | Unclear if follow-up of cohorts was adequate | |
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