Garfinkel D, Mangin D. Feasibility Study of a Systematic Approach for Discontinuation of Multiple Medications in Older Adults Addressing Polypharmacy. Archives of Internal Medicine 2010;170:1648-54
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/20937924
Full text article: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/226051
Methods | Study design: Before-and-after study
Number of groups: One group |
Participants | Number of participants: 70 enrolled, 70 completed
Age: 82.8 ± 6.9 years (range 67 – 102 years) Sex: 43 female, 27 male Participants with dementia: Yes – 40 out of 70 diagnosed with dementia · MMSE score: 18.2 ± 9.4 (range 0 to 30) Inclusion criteria: · Not described Exclusion criteria: · Advanced disease (cancer or non-cancer) in whom the initial estimate of life expectancy was less than 3 months · Follow-up availability less than 4 months Concomitant medicine: 7.7 ± 3.7 medicines (range 0 to 16) Country: Israel Setting: Community |
Interventions | Medicine: Targeted as many medicines as possible
Withdrawal schedule: Not described Investigator-led intervention: Intervention by geriatrician who identified deprescribing targets and undertook the deprescribing process Tool to identify deprescribing targets: Good Palliation-Good Practice tool |
Outcomes | Symptom recurrence after discontinuation
Successful deprescribing rate Global assessment scale Cognitive function – MMSE Hospital admission Commenced recommended new medicine |
Dates | Dates: February 2005 to June 2008
Follow-up duration: 19.2 ± 11.4 months (range 4 to 45 months) |
Funding sources | Financial Disclosure: None reported |
Notes |
Risk of bias table
Bias | Authors’ judgment | Support for judgment |
Random sequence generation (selection bias) | High risk | This was a before-and-after study, not a randomized study.
Allocated by application of geriatric-palliative method |
Allocation concealment (selection bias) | High risk | The allocationwas not concealed. |
Blinding of participants and personnel (performance bias) | 5 out of 5 | This was an open study. |
Blinding of outcome assessment (detection bias) | 5 out of 5 | As above |
Incomplete outcome data (attrition bias) | 1 out of 5 | The interventiongroup was fully reported,but control group was omitted. |
Selective reporting (reporting bias) | 4 out of 5 | Stated outcomes were reported.
Prospective study. “All participants were carefully monitored for any change in symptoms, signs, or relevant laboratory and diagnostic test results that were the originalindications for starting the medications.” Changes in these parameters were not reported, but this may be as they were safety precautions rather than outcomes. The outcomes section is large and indicates a pre-specified protocol, but the specific symptoms are necessarily vague because of the wide range of medications and diseases involved. The risk of bias is raised because many of the signs and symptoms rely on subjective opinions and a self-administeredrating scale. |
Confounding (non-randomized) | 4 out of 5 | Recruitment is from patients referred to the authors’ private practice. As the author is a geriatrician, this means that the participants are representative of a cohort referred to a geriatrician by their primary care physician. Thus, they may be representative of a less well cohort than the typical community-dwelling older adult. “This prospective cohort study included consecutive elderly patients referred by their family physician or family for comprehensive geriatric assessments” “75 consecutive potentially eligible patients were identified.”
Open methodology and mixeddisease states make it hard to attribute causation. This paper referred to an randomized controlled trial using a similar tool. |
Other bias | High risk | Psychological factors are acknowledgedin the discussion but may have a large effect on the outcomes e.g. without a concurrent control group;the self-rated improvement reported could have been a placebo effect or regression to the mean over time. However, in this subpopulation with severe comorbidity (mean [SD] age, 82.8 [6.9] years), it seems unlikely that the natural history in 88% would be subjectively defined as overall improvement owing to a placebo effect. |
Newcastle-Ottawa scale | ||
Selection bias | Representativeness of the exposed cohort | The cohort is a selected group of users. (Multiple comorbidities who are referred to a geriatrician). |
Selection of the non-exposed cohort | There was no concurrent control group. | |
Ascertainment of exposure | Ascertainment of exposure was through structured interviews. | |
Demonstration that outcome of interest was not present at start of study | Yes, 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 studycontrols for the reduction of polypharmacy. |
Outcome bias | Assessment of outcome | Assessment of outcome by self-report. |
Was follow-up long enough for outcomes to occur | Follow-upduration was long enough for outcomes to occur.
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Adequacy of follow-up of cohorts | Complete follow-up – all subjects accounted for. |
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