Alsop K, Mac Mahon M. Withdrawing cardiovascular medications at a syncope clinic. Postgraduate Medical Journal 2001;77:403-05
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/11375457
Full text article: https://pmj.bmj.com/content/77/908/403.long
| Methods | Study design: Before-and-after study
Number of groups: One group |
| Participants | Number of participants: 65 enrolled
Age: 80 years (range 63 to 94 years) Sex: 49 female, 16 male Participants with dementia: No Inclusion criteria: · Not described Exclusion criteria: · Not described Country: England Setting: Community – A syncope clinic where people were referredover incidences such as recurrent unexplained falls and pre-syncope as well as syncope |
| Interventions | Medicine: Antihypertensive were stopped in 41 (63%), combination therapy n=9, thiazides n=18
Withdrawal Schedule: Not described |
| Outcomes | Symptom improvement
Successful deprescribing |
| Dates | Dates: Not described
Follow-up duration: 30 months |
| Funding sources | Not described |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | This was a retrospective chart review of patients at a clinic. There was no sequence generation or control group. |
| Allocation concealment (selection bias) | High risk | There was no allocation concealment, and there was only one group. |
| Blinding of participants and personnel (performance bias) | 5 out of 5 | Open study |
| Blinding of outcome assessment (detection bias) | 5 out of 5 | Open study |
| Incomplete outcome data (attrition bias) | 1 out of 5 | Considered demographic details at baseline and the treating physician’s treatment decisions during follow-up appointments.
There was no missing data. 338 consecutive referrals were considered i.e. no missing patients. Medications were stoppedin 65 participants,and it appears all were reported i.e. “All attendances at the syncope clinic in a two-year period were reviewed.” |
| Selective reporting (reporting bias) | High risk | The methods are described too briefly to be sure, but it appears that the study is based more on the details captured in clinic records than systematic evaluation. |
| Confounding (non-randomized) | 5 out of 5 | The study explores the baseline demographic details, and if the person remained medicine-free, however, it did not control for potential confounders and did not include a comparison group to be able to consider the extent to which the deprescribing intervention was the result of any health changes. |
| Other bias | Unclear risk | The lack of a control group makes this study difficult to draw interpretations. It is a naturalistic study describing the outcomes of the treating physician’s decisions, rather than a deliberate trial of an intervention with a control group.
What were the figures for the same outcomes in the group that had no medication ceased? |
| Newcastle-Ottawa scale | ||
| Selection bias | Representativeness of the exposed cohort | Somewhat representative of referrals who had medication stopped. |
| Selection of the non-exposed cohort | There was no concurrent control group. | |
| Ascertainment of exposure | Ascertainment of exposure through secure record. | |
| Demonstration that outcome of interest was not present at start of study | Yes. | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | No concurrent control group. |
| Outcome bias | Assessment of outcome
|
Outcome assessment by record linkage. |
| Was follow-up long enough for outcomes to occur
|
Follow-up period inadequate for outcomes to occur. Several months would be sufficient to know if the intervention of deprescribing had affected the presence of syncope as an adverse effect. | |
| Adequacy of follow-up of cohorts | Unclear. | |