Beer C, Potter K, Loh P K, et al. A Pilot Randomized Controlled Trial of Deprescribing: Stopat (Systematic Termination of Pharmaceutical Agents Trial). Basic & Clinical Pharmacology & Toxicology 2011;109:156-56
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/25083200
Full text article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110808/
| Methods | Study design: Open-label randomized controlled study with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 44 randomized, 31 completed
25 residents of aged care facilities and ten community-based participants · Intervention deprescribing group: 20 randomized, 12 completed · Control group: 24 randomized, 19 completed Age: 81 ± 9 years Sex: 21 female, 14 male Participants with dementia: Unclear, mean MMSE: 27 ± 2 so may include participants with mild dementia Inclusion criteria: · Takes at least one drug listed in the target drug list · Stable chronic disease on the medication targeted for withdrawal · Reports at least one negative symptom ascribable to the drug therapy (effects specific to drug class, or possible adverse effects such as falls, confusion, malaise, and nausea), or is taking more than five drugs concurrently · Age greater than 60 years · Treating physician agrees to randomization Exclusion criteria: · Patient is taking warfarin Concomitant medicines: 10 ± 2 Country: Australia Setting: Community and residential aged care facilities in Perth, Australia |
| Interventions | Medicine: polypharmacy (a pre-specified list including antihypertensives, anti-anginal, diuretics, non-steroidal anti-inflammatories, COX-2 inhibitors)
Withdrawal schedule: Dose reduced at approximately two-weekly intervals Comparator: Usual care Patient-specific intervention: investigator-led intervention: Intervention by doctor who identified deprescribing targets and undertook the deprescribing process Tool to identify deprescribing targets: pre-specified list of medications |
| Outcomes | Short-form 36 health survey
EuroQol 5-D visual analog scale Sleep quality MMSE Medication Adherence |
| Dates | Dates: July 2007 to April 2010
Follow-up duration: 12 weeks |
| Funding sources | Royal Perth Hospital Medical Research Foundation |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Low risk | “Participants were openly assigned to intervention or control groups using a randomization table, prospectively created using a computerized random number generator.” |
| Allocation concealment (selection bias) | High risk | Patients were openly assigned using a pre-printed table. |
| Blinding of participants and personnel (performance bias) | High risk | This was an open study. Participants were not blinded, but this is unlikely to affect the result. Similarly,blinding of personal would not affect the outcome as the intervention was a structured approach. |
| Blinding of outcome assessment (detection bias) | Unclear risk | It was not clear who were the outcome assessors and whether they were blinded or not. Since the outcome assessment scales have some room for subjective assessment, it is critical that the assessors would be blinded. |
| Incomplete outcome data (attrition bias) | Low risk | The analysis included all participants randomized (n=35) though not all enrolled (n=44). Reasons for attrition and exclusion are described. There were few withdrawals from the study, and this was unlikely to affect the results.
The prospective aims of this study implicit in the method were either not measured or not reported. |
| Selective reporting (reporting bias) | High risk | As a pilot study, this demonstrates that the withdrawal technique can be used. This was a valid question to answer. However, the prospective aims of this study implicit in the method were either not measured or not reported.
5 scales were proposed to measure outcomes (Short-Form 36, EuroQol-5D visual analog scale, medication adherence, assessed with the Medication Adherence Scale, sleep quality assessed using the Pittsburgh Sleep Quality Index andcognitive function, assessed using the MMSE). None of these were reportedin the results or the discussion. Table 1 then lists the drug groups and general statements as to criteria for benefit or withdrawal from the study. Table 2 then lists results in a third was which was whether withdrawal of the agent was achieved or dose reduction achieved or not. |
| Other bias | Low risk | Not identified. |
Leave a Reply