Potter K, Flicker L, Page A, et al. Deprescribing in Frail Older People: A Randomised Controlled Trial. PLos One 2016;11(3):e0149984.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/26942907
Full text article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4778763/
| Methods | Study design: Open-label randomized controlled study with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 95 randomized, 67 completed
· Active deprescribing group: 47 randomized, 35 completed · Control group: 48 randomized, 32 completed Age: 84.3 +/- 6.9 Sex: 49 female, 46 male Participants with dementia: Yes, mean MMSE 15/30 Inclusion criteria: · Aged over 65 years · Living in a Residential Aged Care Facility in the Mid-West region of Western Australia · Taking at least one regular medicine Exclusion criteria: · Final terminal stages of cancer or other serious disease · They were not competent to consent, and their next of kin did not agree to their participation · Their usual doctor did not agree to their participation in the study · Residential aged care facility nurse manager objected to their participation Concomitant medicines: 9.6 +/- 4.3 medicines Country: Australia Setting: Residential aged care facilities |
| 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 Method to identify target: Patient-specific intervention Investigator-led intervention: Intervention by two doctors (one general practitioner and one geriatrician) who identified deprescribing targets and undertook the deprescribing process Tool to identify deprescribing targets: modified Good Palliation-Good Practice tool.52 |
| Outcomes | Median number of regular medicines
Cognitive function Independence in activities of daily living Falls Fractures Sleep quality Bowel function Quality of life Survival |
| Dates | Dates: November 2011 and December 2013
Follow-up duration: 12 months |
| Funding sources | National Health and Medical Research Council of Australia through a post-doctoral fellowship for KP (APP1016241). Additional funding was provided by the Royal Australian College of General Practitioners, The Mason Foundation (philanthropic trust), and the Dementia Collaborative Research Centre |
| Notes | Data was unpublished at the time of the systematic review, but has since been published. |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Low risk | “The random allocation sequence was generated prospectively by a statistician who used a digital random number generator to create permuted-blocks of 2, 4, 6, and 8.” |
| Allocation concealment (selection bias) | Low risk | Allocation concealed.
“The group (A or B) was printed on a slip of paper and sealed in an opaque envelope by the statistician. Envelopes were labeled consecutively from 1 to 250. Participants were assigned an envelope in the order in which they were enrolled. The envelopes were opened to reveal allocation only after the medication review, medication withdrawal plan, and baseline assessments were complete. “ |
| Blinding of participants and personnel (performance bias) | High risk | Open study.
“The primary investigator (KP), community pharmacists, general practitioners, participants, NOK, and Residential Aged Care Facility nurses and carers were all aware of group allocation.” |
| Blinding of outcome assessment (detection bias) | Low risk | The registered nurse who assessed the secondary outcomes was blind to group allocation. |
| Incomplete outcome data (attrition bias) | Low risk | No missing outcomes. |
| Selective reporting (reporting bias) | Low risk | Pre-specified protocol available at the Australian and New Zealand Clinical Trials Registry. Pre-specified outcomes reported. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=336757 |
| Other bias | Low risk | Not identified. |
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