Sommers DK, Reitz CJ, Koch Z, et al. Digoxin withdrawal in patients with sinus rhythm. South African medical journal 1981;60(6):239-40.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/7256472
| Methods | Study design: Before-and-after study
Number of groups: One group |
| Participants | Number of participants: 20 enrolled, 18 completed
Age: 73 years, range 52 to 84 years Sex: 14 female, 6 male Participants with dementia: No Inclusion criteria: · Digoxin because of previously diagnosed left ventricular failure · Clinically stable for at least 3 months · In sinus rhythm with no record of previous atrial fibrillation Exclusion criteria: · Not described Concomitant medicines: Other treatment remained unchanged: diuretic only n=10, diuretic and methyldopa n=4, diuretic and beta-blocker n=3, methyldopa only n=1 Country: South Africa Setting: Community |
| Interventions | Medicine: Digoxin
Withdrawal schedule: Abrupt |
| Outcomes | Clinical evaluation
Successful deprescribing |
| Dates | Dates: Not described
Follow-up duration: 15 months |
| Funding sources | Not declared |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | Not a randomized study design. Before-and-after design. |
| Allocation concealment (selection bias) | High risk | Not concealed. No concurrent control group. |
| Blinding of participants and personnel (performance bias) | 5 out of 5 | Patients and personnel were not blinded. |
| Blinding of outcome assessment (detection bias) | 1 out of 5 | Systolic time intervals and echos were interpreted by blinded staff. |
| Incomplete outcome data (attrition bias) | 1 out of 5 | All patients completed the trial. |
| Selective reporting (reporting bias) | 5 out of 5 | Clinical assessment was pre-specified as measurement of systolic time intervals and M-Echo. The actual values were not reported although the conclusions from these measurements were. In the table, many other clinical signs and symptoms were reported which were in the method but not listed as outcomes. |
| Confounding (non-randomized) | 5 out of 5 | No concurrent control group. No list of confounders. |
| Other bias | Low risk | |
| Newcastle-Ottawa scale | ||
| Selection bias | Representativeness of the exposed cohort | The intervention cohort was truly representative. |
| Selection of the non-exposed cohort | There was no concurrent control group.
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| Ascertainment of exposure | No ascertainment of exposure.
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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 the study. | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | The study controlled for the cessation of digoxin. |
| Outcome bias | Assessment of outcome | Outcome of assessment was by secure record. |
| Was follow-up long enough for outcomes to occur | Follow-up was probably long enough for outcomes to occur. | |
| Adequacy of follow-up of cohorts | Adequate follow-up of participants. | |
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