Fonrose HA, Ahlbaum N, Bugatch E, et al. The efficacy of digitalis withdrawal in an institutional aged population. J Am Geriatr Soc 1974;22(5):208-11
Not PubMed listed
Full text article: https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1532-5415.1974.tb01940.x
| Methods | Study design: Placebo-controlled before-and-after study
Number of groups: One group |
| Participants | Number of participants: 31 enrolled
Age: 83 years (64 to 92 years) Sex: 28 female, 3 male Participants with dementia: No Inclusion criteria: · Digitalization must have been startedearlier than the preceding twelve months · No evidence of congestive heart failure · No evidence of atrial fibrillation · No history of paroxysmal atrial tachycardia or paroxysmal atrial fibrillation · No diagnosis of rheumatic heart disease · Normal heart size as demonstrated by chest x-ray examination · Absence of specific electrocardiographic changes (i.e., left bundle-branch block or recent myocardial infarction) · Unanimous agreement by all members of the screening team that the patient is acceptable for withdrawal of digitalis therapy Exclusion criteria: · Not described Country: United States of America Setting: Residential aged care facilities – A. Holly Patterson Home for the Aged and Infirm in Uniondale, New York. The home was administered by the Nassau County Department of Social Services, and medical care is provided by a team of part-time internists. |
| Interventions | Medicine: Digoxin
Withdrawal schedule: Not described |
| Outcomes | Successful deprescribing
Adverse events Death |
| Dates | Dates: Not described
Follow-up duration: Four months |
| Funding sources | Not described |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | The study not randomized. |
| Allocation concealment (selection bias) | High risk | Only one arm. |
| Blinding of participants and personnel (performance bias) | 1 out of 5 |
“After replacement of the digoxin preparation with an identical placebo tablet (supplied by Burroughs Wellcome Co.)…” |
| Blinding of outcome assessment (detection bias) | 5 out of 5 | Only one arm. |
| Incomplete outcome data (attrition bias) | 1 out of 5 | All outcomes appear to be reported. |
| Selective reporting (reporting bias) | Unclear risk | There is no evidence of a pre-specified protocol and analysis plan, and the objectives are stated unclearly. |
| Confounding (non-randomized) | 5 out of 5 | This is a single-arm study, so it is at risk of confounding from uncontrolled external factors. |
| Other bias | High risk | This study from 1974 does not conform to modern expectations for a published study and is missing information that would be included today in a paper that reported using the PRISMA statement. However, it is clear that they were thoughtful to consider contemporary developments and to control for factors recognized at the time.
e.g. “The significance of creatinine clearance in an aged population was recently evaluated by Friedman et al. (5); they showed that kidney function decreased with age. Taking this into account,concurrent values were obtained on the patients in this study.” Friedman SA et al.Functional defects in the aging kidney, Ann btMed 76: 41, 1972. Further, the rapidity with which many participants deteriorated in this study with symptoms of congestive heart failure may be indicative of changed treatment guidelines since 1971 when the study was conducted. Obviously, these participants were not exposed to modern angiotensin blockade, beta-blockers or loop diuretics. This affects the study’s generalizability to the modern clinical setting. |
| Selection bias | Representativeness of the exposed cohort | Representativeness of the exposed cohort is hard to establish due to limited patient information but is probably a trulyrepresentative sample of the residential aged care population in 1971. |
| Selection of the non-exposed cohort | There is no concurrent control group. | |
| Ascertainment of exposure | Ascertainment of exposure is via secure record. | |
| Demonstration that outcome of interest was not present at start of study | The researchers demonstrated that the outcome of interest was not present at the startof the study. | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | The study controls for digoxin exposure. |
| Outcome bias | Assessment of outcome | Outcome assessment was by self-report. |
| Was follow-up long enough for outcomes to occur | The follow-up duration could have been sufficient for outcomes to occur.
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| Adequacy of follow-up of cohorts | Follow-up was complete, with all subjects accounted for. |
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