Avraham, O., & Biglow, M. Implementation of Proton Pump Inhibitor Deprescription Protocol in Geriatric Residents. Annals of Pharmacotherapy, 2018, 52(8), 747–753.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/29473423
| Methods | Study design: Prospective single-group intervention study
Number of groups: 1 |
| Participants | Number of participants: 10
Age: median 65.6 (range 52-92) Female: 7 (70%) Participants with dementia: Unclear Inclusion criteria: · ≥50 years Proton pump inhibitor therapy >4 weeks Exclusion criteria: Barrett oesophagus Tumour or metastasis Mechanical ventilation Hospice or palliative care Radiotherapy or chemotherapy Pathological hypersecretory condition Antiplatelet or anticoagulant therapy Variceal or gastrointestinal haemorrhage Concomitant medicines: median 16.8 (range 10-29) Country: United States Setting: 400+ bed residential aged care facility |
| Interventions | Medicine: Proton pump inhibitor
Withdrawal schedule: Decrease by half every 2-4 weeks, until lowest dose denominator reached, then dose every other day for 2-4 weeks. If symptomatic resume former dose. If asymptomatic, commence famotidine 20mg for 2-4 weeks; then every other day and assess after 2-4 weeks. Discontinue or continue famotidine as needed. |
| Outcomes | Hospitalisation
Symptom assessment score Change in medication burden Laboratory parameters Guaiac test Monthly weight |
| Dates | Dates: April 2017 – June 2017
Follow-up duration: 3 months |
| Funding sources | Nil reported |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Low risk | Single arm study |
| Allocation concealment (selection bias) | High risk | Single arm study |
| Blinding of participants and personnel (performance bias) | High | All nurses, residents, pharmacists and physicians educated about harms, intents, methods, and duration. |
| Blinding of outcome assessment (detection bias) | High | Pharmacists conducted both the interventions and assessments |
| Incomplete outcome data (attrition bias) | High | No attrition rate reported. Some outcomes not reported for all participants (eg symptom assessment in non-verbal patients) |
| Selective reporting (reporting bias) | High | Several outcomes detailed in methods not reported in results, including quality of life, Guaiac test, monthly weight and laboratory parameters |
| Confounding (non-randomized) | High | Some confounding variables mentioned in the discussion, however not accounted for in methods or results |
| Other bias | High | Primary outcome (symptom assessment) measured two different ways: a validated tool in verbal patients, and clinician judgement in others |
| Selection bias | Representativeness of the exposed cohort | Selected group of proton pump inhibitor users |
| Selection of the non-exposed cohort | No non-exposed cohort | |
| Ascertainment of exposure | Secure record | |
| 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 gastric acid irritation |
| Outcome bias | Assessment of outcome | Self-report |
| Was follow-up long enough for outcomes to occur | No, recommend 6-12 months | |
| Adequacy of follow-up of cohorts | No statement | |
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