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| Methods | Study design: Single arm clinical study involving two quality improvement initiatives rolled out to the entire group. |
| Participants | Number of participants:
Cohort 1: 52,869 Cohort 2: 21,329 (65% targeted in first cohort also) Age: Not reported. 73% of the Veterans’ MATES population is ≥65 years of age Sex: Cohort 1: 51% female; Cohort 2: 55% female Participants with dementia: Unclear Inclusion criteria: Veterans Cohort 1: ≥1 hypnotic medicine dispensed 1/1/08-31/12/08 Cohort 2: ≥2 hypnotic medicines dispensed 1/10/11-31/1/12 Country: Australia Setting: Community and residential aged care facilities |
| Interventions | Medicine: Benzodiazepines
Intervention: National intervention involving GPs, veterans, pharmacists and directors of care in aged care facilities. Administrative claims data were used to identify patients dispensed hypnotics and to create patient-specific and prescriber-specific feedback. Withdrawal schedule: Not described |
| Outcomes | Rate of hypnotic use per month (number of veterans receiving any hypnotic in the month divided by the total number of veterans alive in that month)
Change in hypnotic dispensing trends Patient months of treatment and adjusted differences were used to estimate avoided hospitalisations due to confusion |
| Dates | Dates: March 2009 to June 2012
Follow-up duration: 12 months |
| Funding sources | Australian Government Department of Veterans’ Affairs, as part of the Veterans’ MATES program. |
| Notes | Part of the Veterans Medicines Advice and Therapeutics Education Services (Veterans’ MATES) quality improvement program |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Low | Single arm study. Dispensing data used to identify and include all eligible people |
| Allocation concealment (selection bias) | Low | Single arm study with all eligible people receiving the intervention |
| Blinding of participants and personnel (performance bias) | Low | Dispensing data used to include all eligible people |
| Blinding of outcome assessment (detection bias) | High | Outcome assessors not described |
| Incomplete outcome data (attrition bias) | Low | Outcomes not participant-specific; instead overall claims data analysed |
| Selective reporting (reporting bias) | Low | Ethics approval provided by the DVA |
| Confounding (non-randomized) | Low | No comparison group |
| Other bias | ||
| Selection bias | Representativeness of the exposed cohort | Truly representative |
| Selection of the non-exposed cohort | No non-exposed group | |
| Ascertainment of exposure | Secure records | |
| Demonstration that outcome of interest was not present at start of study | Yes | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | Controls for benzodiazepine use |
| Outcome bias | Assessment of outcome | Records |
| Was follow-up long enough for outcomes to occur | Yes | |
| Adequacy of follow-up of cohorts | Loss to follow-up not assessed as outcomes were assessed at the group level | |
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