Gerety MB, Cornell JE, Plichta DT, et al. Adverse events related to drugs and drug withdrawal in nursing home residents. Journal of the American Geriatrics Society 1993;41(12):1326-32
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/8227915
| Methods | Study design: Before-and-after study
Number of groups: One group |
| Participants | Number of participants: 132 enrolled, 132 completed
Age: 70.1 ± 12.3 years Sex: 7 female, 168 male Participants with dementia: No Inclusion criteria: · New admission to the participating residential aged care facility · Participants who had complete data for 6 months Exclusion criteria: · Not described Concomitant medicines: 7 ± 3.4 Country: United States of America Setting: Residential aged care facilities |
| Interventions | Medicine: Polypharmacy
Withdrawal schedule: Not described Method to identify targets: Patient-specific intervention: medication review: Recommendation by a clinical pharmacist Recommendation to a physician (geriatrician) Tool to identify deprescribing targets: Health professional judgment (no list, criteria, or tool used) |
| Outcomes | Incidence and severity of adverse drug events
Incidence and severity of adverse drug withdrawal events Demographic factors associated with risk of adverse drug events and adverse drug withdrawal events. Change in medicine use |
| Dates | Dates: February 1988 to September 1989
Follow-up duration: Six months |
| Funding sources | American Federation of Aging Research/Merck Foundation Geriatric Clinical Pharmacology Award |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | Not randomized |
| Allocation concealment (selection bias) | High risk | Retrospective chart review – not applicable |
| Blinding of participants and personnel (performance bias) | 5 out of 5 | Retrospective chart review – not blinded |
| Blinding of outcome assessment (detection bias) | 5 out of 5 | As above |
| Incomplete outcome data (attrition bias) | 1 out of 5 | Given the study method (retrospective chart review), the authors elected to include all participants for whom a full record was available. They accounted for the missing data and undertook appropriate methods to ascertain if it was likely to have had an impact on the outcomes.
“To standardize exposure time to potential medication changes and adverse drug events, we limited analyses of changes in medications and event rates to patients who had complete data for 6 months.” “Subjects whose records were unavailable were younger (65.0 ± 16 vs.. 70.1±12.3, P = 0.06), but were not different with respect to activities of daily living dependencies, length of stay in the nursing home, total hospital days, or mortality.” |
| Selective reporting (reporting bias) | 5 out of 5 | There is no evidence of a pre-specified protocol and analysis plan. The objectives were not clearly stated, but do not appear to have all been reported on. Additionally, there were outcomes reported that were not stated as an objective. |
| Confounding (non-randomized) | 5 out of 5 | Retrospective chart review cannot control for confounding. |
| Other bias | High risk | The study method (retrospective chart review) is one that has the potential for bias. The authors acknowledge this in their discussion:
“…assessment of risk factors by chart abstraction is necessarily limited. Chart data, particularly with respect to diagnoses, may be both inaccurate and biased. Some diagnoses, such as depression, dementia, and sensory impairments, are commonly under-reported, while others, such as COPD, may be over-reported. We elected an inclusive strategy with respect to recorded diagnoses because this gave the prescribing physician the benefit of the doubt for medication indications.” |
| Newcastle-Ottawa scale | ||
| Selection bias | Representativeness of the exposed cohort | The intervention cohort was somewhat representative of older adults in a residential aged care facility. |
| Selection of the non-exposed cohort | There was no concurrent control group.
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| Ascertainment of exposure | Ascertainment of exposure was through secure record.
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| Demonstration that outcome of interest was not present at start of study | It was demonstrated that the outcome of interest was not present at the start of study. | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | The study controls for medicine use. |
| Outcome bias | Assessment of outcome | Assessment of outcome was through record linkage. |
| Was follow-up long enough for outcomes to occur | The follow-up duration was probably sufficient for the outcome to occur.
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| Adequacy of follow-up of cohorts | Follow-up was complete,and all subjects were accounted for. | |
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