Wilkins CE, Khurana MS. Digitalis withdrawal in elderly nursing home patients. J Am Geriatr Soc 1985;33(12):850-51
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/4067167
| Methods | Study design: Before-and-after study
Number of groups: One group |
| Participants | Number of participants: 19 enrolled, 19 completed
Age: 84.9 years Sex: 16 female, 3 male Participants with dementia: No Inclusion criteria: · Resident at participating aged care facility · Taking digoxin Exclusion criteria: · Atrial fibrillation · Congestive heart failure Country: United States of America Setting: Residential aged care facilities – a single 62 bed residential aged care facility |
| Interventions | Medicine: Digoxin, started in patients because of: atrial fibrillation (n=1), congestive heart failure (n=3), no identifiable reason (n=15)
Withdrawal schedule: Not described |
| Outcomes | Adverse drug withdrawal effects
Pulse Weight |
| Dates | Dates: Not described
Duration: 4 months |
| Funding sources | St. Elizabeth Hospital Medical Center |
| Notes | Limited detail
Additional information sought to find duration of follow up, but not received. |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | Observational study. |
| Allocation concealment (selection bias) | High risk | Not concealed. |
| Blinding of participants and personnel (performance bias) | 5 out of 5 | Open study. |
| Blinding of outcome assessment (detection bias) | 5 out of 5 | There are no absolute numbers given pulse and blood pressure for all participants. |
| Incomplete outcome data (attrition bias) | 1 out of 5 | No missing data. |
| Selective reporting (reporting bias) | 5 out of 5 | There is no evidence of a pre-specified protocol and analysis plan. The stated objectives are unclear, so it is uncertain if outcome reporting is selective. |
| Confounding (non-randomized) | 5 out of 5 | No control group. The methods section is insufficiently developed to ascertain if other sources of bias may be present. |
| Other bias | Unclear risk | The methods section is insufficiently developed to ascertain if other sources of bias may be present. Insufficient participant detail given to judge if the groups were equivalent at baseline. |
| Newcastle-Ottawa scale | ||
| Selection bias | Representativeness of the exposed cohort | No description of the derivation of the cohort. |
| Selection of the non-exposed cohort | No concurrent cohort group.
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| Ascertainment of exposure | Ascertainment of exposure was by secure record. | |
| 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 | The study controlled for digoxin therapy. |
| Outcome bias | Assessment of outcome | Assessment of outcome by structured interview. |
| Was follow-up long enough for outcomes to occur | Follow-up probably would have needed to be longer for outcomes to occur. | |
| Adequacy of follow-up of cohorts | Complete follow-up – all subjects accounted for. | |
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