Pitkala KH, Strandberg TE, Tilvis RS. Is it possible to reduce polypharmacy in the elderly? A randomised, controlled trial. Drugs & Aging 2001;18:143-49
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/11346128
Full text article: https://link.springer.com/article/10.2165%2F00002512-200118020-00007
| Methods | Study design: Open-label pseudo-randomized controlled study with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 174 randomized, 174 completed
· Intervention deprescribing group: 88 enrolled, 88 completed · Control group: 86 enrolled, 86 completed Age: 77 years (range 43 to 91 years) Sex: 114 female, 60 male Participants with dementia: 68 participants · Mild: Intervention group n=18 (20%), control group n=17 (20%) · Moderate: Intervention group n=11 (13%), control group n=12 (14%) · Severe: Intervention group n=3 (3.4%), control group n=7 (8%) Inclusion criteria: · Not described Exclusion criteria: · Not described Concomitant medicines: 5.4 ± 2.6 Country: Finland Setting: Community |
| Interventions | Medicine: Polypharmacy
Withdrawal schedule: Not described Other interventions: day hospital care for the intervention group Comparator: Deprescribing and day hospital care for the intervention group, and regular home care in the community for the control group Method to identify targets: Patient-specific intervention: investigator-led intervention: Intervention by hospital-based physician after a nurse had developed a comprehensive assessment including medication reconciliation Tool to identify deprescribing targets: Doctor’s choice – no specified list, criteria or tool used |
| Outcomes | Drug utilization |
| Dates | Dates: Not described
Follow-up duration: Two months |
| Funding sources | Ragnar Ekberg Foundation, the Research Council of Medical Sciences (The Academy of Finland), the Finnish Medical Society Duodecim, the Orion Corporation Research Foundation and the Kirkkonummi-Siuntio primary healthcare center. |
| Notes | Deprescribing is not the only intervention in this study, so there is the potential for confounding when considering deprescribing data. |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | Method not truly random.
“Randomized by their date of birth into two groups.” |
| Allocation concealment (selection bias) | High risk | Open study. |
| Blinding of participants and personnel (performance bias) | High risk | Open study. |
| Blinding of outcome assessment (detection bias) | High risk | Open study. |
| Incomplete outcome data (attrition bias) | Unclear risk | It is not addressed if participants withdrew for any reason other than non-consent.
“The patients refusing to participate were included in the analysis according to the ‘intention-to-treat’ approach.” |
| Selective reporting (reporting bias) | Low risk | The intended outcome that was described in the paper was reported. |
| Other bias | Unclear risk | Deprescribing was not the only intervention that the intervention group received. The reduction of polypharmacy was an add-on intervention to the intensive day therapy that the participants were receiving.
The methodology of this trial does not adequately address the possibility of Hawthorne Effect or effect of receiving extra attention. Therefore, potential for both groups results to be skewed by additional intervention. The groups were not treated equally. |
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