Table 2.
Randomized controlled trials of STOPP/START as an intervention tool.
| Reference | Setting | Outcomes | Intervention | Results | Limitations |
|---|---|---|---|---|---|
| Gallagher and colleagues42 | Hospitalized patients ⩾65 years, single center, Ireland. n = 400. | Impact of intervention on prescribing appropriateness (as measured by the MAI and AOU) at hospital discharge and at 2, 4, and 6 months. Secondary outcomes: (i) LOS in hospital; (ii) readmissions (iii); falls; (iv) all-cause mortality |
Within 24 h of admission, participants were randomized to usual pharmaceutical care (control group) or IMU screening by research physician using the STOPP/START criteria. Attending physician received oral and written recommendations. | 41.7% of patients were prescribed ⩾1 PIMs at hospital admission. 91% of STOPP recommendations accepted. IMU significantly lowered in intervention group at discharge (absolute risk reduction 35.7%, number of patients needed to screen to yield improvement in MAI = 2.8). Improvements sustained for 6 months. No significant difference in secondary outcomes between groups. No reduction in polypharmacy. |
Single center study. Potential for bias: Outcomes were assessed by unblinded researcher. However, outcome data from 10% of participants were randomly selected and evaluated by blinded physician. Good inter-rater reliability for all 10 MAI criteria (κ-coefficients >0.85). |
| Dalleur and colleagues47 | Hospitalized patients ⩾75, single center, Belgium. n = 146 |
Impact of intervention on the prescriptions of PIMs at hospital discharge and at 1 year. | Older adults referred by medical team for specialist geriatric input were randomized to (i) CGA alone (control group), or (ii) CGA plus IMU screening using STOPP criteria. Attending physician overseeing care of patients received oral and written recommendations. |
52% of patients were prescribed ⩾1 PIMs at the time of hospital admission. 39.7% of STOPP recommendations accepted. In the intervention group, 39.7% of PIMs were discontinued compared with 19.3% in the control group (p = 0.013). Number PIMs needed to screen with STOPP to yield one additional PIM discontinuation = 5. At 1 year, 38% of PIMs had been restarted. Effect of intervention on polypharmacy not reported. |
Single center study Small sample size STOPP criterion A3 (duplicate drug classes) not used. |
| Frankenthal and colleagues46 | Nursing home residents ⩾65 years, single center, Israel. n = 359 |
Impact of intervention on falls, QoL, hospitalizations, functional status, and monthly cost of medications at 1 year. | Residents received usual pharmaceutical care (control group) or IMU screening by a research pharmacist using the STOPP/ START criteria. Research pharmacist communicated recommendations to chief physician. | 67.7% of participants were prescribed ⩾1 PIMs at the onset of the trial. 82.4% of STOPP recommendations accepted. Significant reduction in polypharmacy in intervention group compared with control group (see Table 3) At 1 year, significant reduction in average cost of drugs per month per patient in intervention group compared with control Significant reduction in incident falls in intervention group compared with control. No significant difference between groups in QoL, functional status and hospitalizations. |
Single center. Limited training for blinded outcome assessors (single 1-hour training session for staff nurses). |
| O’Connor and colleagues45 | Hospitalized patients ⩾65 years, single center, Ireland. n = 732 | Impact of intervention on nontrivial hospital-acquired ADRs up to day 7–10 or day of discharge, whichever came first. Secondary outcomes: (i) LOS; (ii) monthly cost of medications |
On admission, participants were randomized to usual pharmaceutical care or IMU screening by research physician using the STOPP/START criteria. Attending physician received oral and written recommendations within 48 h of admission. | 45.6% of participants were prescribed ⩾1 PIMs at hospital admission. 81.2% of STOPP recommendations accepted. Reduced ADR rate in intervention group compared with control (12.5% versus 23.9%). Number of patients needed to screen to prevent 1 ADR = 9. Median monthly cost of medications significantly lower in intervention group compared with control. No significant difference in LOS between groups. |
Single center. ADRs after day 10 not included. Potential for bias: potential ADRs were diagnosed by unblinded researcher. However, these events were accepted only if designated ‘probable’ or ‘certain’ by second blinded researcher using validated ADR causality tool. |
ADR, adverse drug reaction; AOU, assessment of under-utilization; CGA, comprehensive geriatric assessment; IMU, inappropriate medication use; LOS, length of stay in hospital; MAI, medication appropriateness index; PIMs, potentially inappropriate medications; QoL, quality of life; START, Screening Tool to Alert doctors to the Right Treatment; STOPP, Screening Tool of Older Persons potentially inappropriate Prescriptions.