Gallagher PF, O’Connor MN, O’Mahony D. Prevention of Potentially Inappropriate Prescribing for Elderly Patients: A Randomized Controlled Trial Using STOPP/START Criteria. Clinical Pharmacology and Therapeutics 2011;89(6):845-54.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/21508941
Full text article: https://ascpt.onlinelibrary.wiley.com/doi/full/10.1038/clpt.2011.44
| Methods | Study design: Open-label randomized controlled study with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 400 randomized, 382 participating at discharge, 358 completed
· Intervention deprescribing group: 200 randomized, 180 completed · Control group: 200 randomized, 178 completed Age: median 74.5 years (interquartile range, 71–80) Sex: 203 female, 179 male Participants with dementia: 38 participants (23 control group, 15 intervention group) Inclusion criteria: · Aged ≥65 years · Admitted via the emergency department under the care of a general medical physician Exclusion criteria: · Age <65 years · Admission to the hospital under the care of a geriatrician, a psychiatrist specializing in the care of the elderly, or a clinical pharmacologist, or having been assessed by such a specialist in the year preceding admission · Critical illness, e.g., admitted to intensive or coronary care units · Terminal illness · Unwillingness of the patient or the hospital physician to participate in the study Concomitant medicines: median 7 (interquartile range 5–10) Country: Ireland Setting: Hospital – Cork University Hospital, an 800-bed, state-funded, tertiary medical center in southern Ireland serving an urban and rural population |
| Interventions | Medicines: Those identified as potentially inappropriate medicines in the STOPP/START criteria
Withdrawal schedule: Not described Comparator: Usual care Method to identify targets: Patient-specific intervention: medication review: Recommendation by the primary research physician Recommendation to treating physician Tool to identify deprescribing targets: STOPP/START criteria |
| Outcomes | Medicine Appropriateness Index
Assessment of Underutilization index STOPP/START criteria – participants with at least one item Falls All cause mortality Duration of initial hospital stay Hospital readmission General practitioner visits |
| Dates | Dates: Not described
Follow-up Duration: Six months |
| Funding sources | Health Research Board of Ireland, Clinical Research Training Fellowship number CRT/2006/029 |
| Notes | Authors stated: “Conflict of Interest: The authors declared no conflict of interest.”
Additional information sought, but not received. |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Low risk | The randomization sequence was determined by an independently generated random-numbers table using StatsDirect software, version 4.5. |
| Allocation concealment (selection bias) | Low risk | The random-numbers table was retained, independent of the researchers, by a physician external to the study who assigned participants to groups using a sealed-envelope system. Group allocation was concealed from the research physician and participants until baseline data had been collected and inclusion criteria verified. Participants in the control group received usual hospital physician and pharmacist care. |
| Blinding of participants and personnel (performance bias) | High risk | The intervention could not be blinded as it was the application of a tool (STOP/START) and then direct contact with the treating team. |
| Blinding of outcome assessment (detection bias) | High risk | As above. |
| Incomplete outcome data (attrition bias) | Low risk | No incomplete data wereidentified at the initial stage. Later incomplete data due to death was “For patients in whom all follow-up assessments were not completed because of death in the follow-up period (n = 24), the scores relating to prescribing appropriateness from their last available study contact were used in a last-observation-carried-forward analysis.” |
| Selective reporting (reporting bias) | Low risk | Both primary and secondary outcome measure were well reported. |
| Other bias | Low risk |
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