Van Der Velde N, Stricker BHCh, Pols HAP, et al. Risk of falls after withdrawal of fall-risk-increasing drugs: A prospective cohort study. British Journal of Clinical Pharmacology 2007;63:232-37.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/16939531
Full text article: https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1111/j.1365-2125.2006.02736.x
Van Der Velde N, Stricker BHCh, Pols HAP, et al. Withdrawal of fall-risk-increasing drugs in older persons: Effect on mobility test outcomes. Drugs & Aging 2007;24(8):691-99.
PubMed link:https://www.ncbi.nlm.nih.gov/pubmed/17493193
Full text article: https://onlinelibrary.wiley.com/doi/full/10.1111/j.1532-5415.2007.01137.x
| Methods | Study design: Case-control study
Number of groups: Two groups |
| Participants | Number of participants: 141 enrolled, 139 completed
· Intervention deprescribing group: 75 participants · Control group: 64 participants Age: 78.4 ± 5.2 years Sex: 105 female, 36 male Participants with dementia: unclear – MMSE: 27.0 ± 2.8 Inclusion criteria: · 65 years or over · History of falling · MMSE of 21 points or higher (out of 30 points) · Able to walk 10 meters without a walking Exclusion criteria: · None stated Concomitant medicines: 6.2 ± 2.6 medicines Country: The Netherlands Setting: Community – All new consecutive referrals to our geriatric out-patient clinic and the diagnostic day center |
| Interventions | Medicine: Medicines that increase the risk of falls
Psychotropic drugs, sedatives, antidepressants, neuroleptics, cardiovascular drugs, antihypertensives, nitrates, antiarrhythmics, nicotinic acid, beta-adrenoreceptor blocker eye drops, analgesics, anti-vertigo preparations, hypoglycemics, urinary antispasmodics and others. Withdrawal schedule: “stopped abruptly, if safely possible, or else reduced in dose over a -month period to a lower dose or to complete withdrawal”Comparator: Deprescribing compared to usual care Method to identify targets: Patient-specific intervention: investigator-led intervention: Intervention by the investigators who identified deprescribing targets and undertook the deprescribing process Tool to identify deprescribing targets: Pre-specified list of target medications |
| Outcomes | Risk of a fall during follow-up
Mobility Testing |
| Dates | Dates: 1 April 2003 and ended 30 November 2004
Follow-up duration: Two months |
| Funding sources | This study was funded by Erasmus University MC, and by funds from Merck Sharp & Dohme, and Will-Pharma. The study’s sponsors had no role in the design and conduct of the study, in the collection, analysis, and interpretation of the data, or in the preparation, review, or approval of the manuscript |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Unclear risk | Cohort study, not randomized. The active (deprescribing) group participants were those who had one or more drugs discontinued that may contribute to the risk of falls. The control (continued medicine) group were those who did not use a medicine that increased the risk of falls or used one that could not be deprescribed.
“We were able to withdraw one or more falls-risk increasing drugs in 75 out of the 139 patients. In 67 patients, falls-risk increasing drugs were discontinued and in eight patients falls-risk increasing drugs doses were reduced. For the other 64 fallers, falls-risk increasing drugs withdrawal was not possible, either because they did not use falls-risk increasing drugs, or because the falls-risk increasing drugs could not be discontinued. Also in eight patients, falls-risk increasing drugs withdrawal was attempted but failed.” |
| Allocation concealment (selection bias) | High risk | Not concealed. |
| Blinding of participants and personnel (performance bias) | 5 out of 5 | Not blinded. |
| Blinding of outcome assessment (detection bias) | 5 out of 5 | Not blinded. |
| Incomplete outcome data (attrition bias) | 5 out of 5 | Relative results reported.
There was no missing outcome data in the first paper, but absolute values were not stated. In the second paper, it was given as an as-treated value, which was significant when there was no explanation as to how the subgroup was selected. |
| Selective reporting (reporting bias) | 5 out of 5 | There was a pre-specified study protocol approved by a Human Research Ethics Committee, however, without a pre-specified published protocol, it is unclear if they adhered to the analysis plan. It is, however, likely that they did so, and the stated objectives are reported. |
| Confounding (non-randomized) | 5 out of 5 | Control group not equivalent at baseline – not a true control group.
“withdrawal of falls-risk increasing drugs is already implemented in Dutch and international falls guidelines, rendering it unethical not to withdraw falls-risk increasing drugs in patients presenting with a fall. Therefore, we performed a prospective cohort study in which we compared the effect of drug withdrawal on the incidence of falls with a group of patients in whom falls-risk increasing drugs withdrawal was not possible.” No description of the subgroup in paper 2. |
| Other bias | High risk | No explanation on how the subgroup was chosen:
“At the end of follow-up (mean duration 6.7 months), a subgroup (65%) was asked back for second testing. This was done for logistical reasons (limited personnel and equipment were available) and selection for second testing was random, depending only on the availability of the testing room and personnel.” Industry-sponsoredstudy, though authors state the sponsors had no further role in the paper. |
| Newcastle-Ottawa scale | ||
| Selection bias | Is the case definition adequate? | Yes. |
| Representativeness of the exposed cohort | Consecutive or obviously representative series of cases.
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| Selection of the non-exposed cohort | Community controls (but selected from a different community).
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| Definition of Controls | No history of disease (end-point) i.e. risk of falls. | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | The study controlled for the risk of falls. |
| Outcome bias | Assessment of outcome | Assessment of outcome is by self-report. |
| Same method of ascertainment for cases and controls | Yes. | |
| Non-Response rate | Same rate for both groups. | |
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