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. 2020 May 8;2020(5):CD012419. doi: 10.1002/14651858.CD012419.pub2

Blalock 2010.

Study characteristics
Methods Aim of study: to assess effects of a community pharmacy‐based falls prevention programme targeting high‐risk older adults on rates of recurrent falls, recurrent injurious falls, and filling prescriptions for medications that have been associated with increased risk of falls
Study design: RCT (1 year look back and 1 year follow‐up after RCT; unit of allocation: individual)
Number of arms/groups: 2
Participants Description: patient/consumer
Geographic location: USA
Setting: community pharmacy
Inclusion criteria: those at high risk of falling (≥ 65 years, ≥ 1 fall not attributable to syncope within the 1 year preceding, ≥ 4 long‐term prescription medications, ≥ 1 CNS‐active medication)
Exclusion criteria: housebound, in long‐term care facility, not able to read and write English, exhibited significant cognitive impairment
Number of participants randomised: 186 (93 intervention, 93 control)
Number of participants included in analysis: 93 and 93 (ITT), 73 and 113 (as treated)
Age: mean (SD): I: 75.5 (7.0) vs C: 74.1 (6.8)
Gender: female: 78.5% intervention vs 65.4% control
Ethnicity: white: 91.4% intervention vs 86.0% control
Number of medications: unclear (inclusion criteria ≥ 4 long‐term prescriptions)
Frailty/Functional impairment: use of cane or walker: 37 (39.8%) vs 43 (46.2%) (P = 0.37)
Cognitive impairment: not specified
Comorbidities: high‐risk conditions (dizziness, diabetes, incontinence, arthritis, Parkinson, stroke): mean (SD): 1.65 ± 1.19 intervention vs 1.58 ± 1.06 control
Interventions Group 1Enhanced pharmacologic care. Invitation to participate in free face‐to‐face medication consultation (~ 45 minutes) with community pharmacy resident. Pharmacist reviewed medications and identified potential problems (emphasis on CNS‐active medications) using structured algorithms. If problem identified and patient interested in making a change, pharmacist contacted physician to seek prescriber approval of the recommended changes
Group 2Usual care: no medication consultation
Co‐intervention: both groups received 2 brochures on prevention of falls
Provider: pharmacist (community)
Where: local health care centre
When and how often: once
Intervention personalised: yes, personalised medication review
Outcomes Timing of outcome assessment: baseline and 12 months
Medication adherence (subjective): BMQ (validated), 5‐item regimen screen that assesses how medication is used
Condition‐specific outcomes (subjective): 1 or more falls. Calculated using monthly fall calendar; patients recorded each fall "a sudden, accidental change in position where you land on the ground, floor, or an object"
Notes Trial registration: N/A
Consumer involvement: not specified
Funding source: National Center for Injury Prevention and Control at the Centers for Disease Control and Prevention
Dropout: 20 did not receive intervention, 27 dropped out (17 vs 10), 9 unable to contact (6 vs 3), 5 died (3 vs 2)
Further information required: BMQ results (email correspondence with trial author ‐ unsuccessful)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomised to either intervention or control ‐ unclear how
Allocation concealment (selection bias) Unclear risk Not specified
Blinding of participants and personnel (performance bias)
All outcomes High risk Unable to blind; patients knew if they had the intervention
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No mention of blinding
Incomplete outcome data (attrition bias)
All outcomes Unclear risk ITT, although no BMQ data, so difficult to assess if/how ITT was done
Selective reporting (reporting bias) High risk "BMQ was readministered at 4 monthly intervals, ending 12 months after the baseline assessment" ‐ results not listed. However BMQ listed as a data source ‐ not an outcome in methods
Other bias Unclear risk Initial sample size was 262; "interim power analyses were conducted when it became apparent that it would be difficult to reach target sample size"
Sample size changed to 95 per group. Sample size based on falls risk