The effect of SENATOR (Software ENgine for the Assessment and optimisation of drug and non-drug Therapy in Older peRsons) on incident adverse drug reactions (ADRs) in an older hospital cohort – Trial Protocol

Lavan, A; O’Mahony, Denis; Gallagher, Paul; Fordham, Richard; Flanagan, Evelyn; Dahly, Darren; Byrne, Stephen; Petrovic, Mirko; Guðmundsson, Adalsteinn; Samúelsson, Ólafur; Cherubini, Antonio; Cruz-Jentoft, Alfonso J.; Soiza, Roy L.; Eustace, Joseph A.

doi:10.1186/s12877-019-1047-9

Cited by 27 publications

(25 citation statements)

References 28 publications

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“…Classifying the identified cases of PPOs into drug classes in this study demonstrated that the most common drug classes associated with identified PPO cases involved vaccines, ACEIs, antiplatelets, statins, and vitamin D/calcium supplements. The findings of the present study were similar to results that were reported by other published studies (Gallagher et al, 2011;Frankenthal et al, 2013;Liu et al, 2012;Ryan et al, 2009).…”

Section: Discussionsupporting

confidence: 93%

“…Future research examining the impact of softwaregenerated START criteria on drug-related hospitalizations and quality of life is needed for implementing medication prescription in day-to-day practice, bearing in mind that such criteria cannot replace clinical judgment. A recent first clinical trial to examine the effectiveness of a software intervention on incidental adverse drug reactions and associated healthcare costs during hospitalization for older patients with polypharmacy and comorbidities is ongoing (Lavan et al, 2019). On the contrary, other researchers claimed that the application of such software did not reduce adverse drug reaction incidence during hospitalization (O'Mahony et al, 2020).…”

Section: Discussionmentioning

confidence: 99%

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Potential prescribing omissions of medications in older adults based on START version 2 criteria in a tertiary Jordanian teaching hospital

Hammour¹,

Abdeljalil²,

Farha³

et al. 2021

J Appl Pharm Sci

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Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Potential prescribing omissions of medications in older adults based on START version 2 criteria in a tertiary Jordanian teaching hospital

Hammour¹,

Abdeljalil²,

Farha³

et al. 2021

J Appl Pharm Sci

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“…These adjustments will, in turn, significantly reduce ADR incidence in intervention arm patients compared to matched patients receiving standard pharmaceutical care in the same medical centre. Further details are provided in a previous trial protocol paper 34 and are summarized in the Supplementary Appendix.…”

Section: Methodsmentioning

confidence: 99%

Prevention of adverse drug reactions in hospitalized older patients with multi-morbidity and polypharmacy: the SENATOR* randomized controlled clinical trial

et al. 2020

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Abstract Background Multi-morbidity and polypharmacy increase the risk of non-trivial adverse drug reactions (ADRs) in older people during hospitalization. Despite this, there are no established interventions for hospital-acquired ADR prevention. Methods We undertook a pragmatic, multi-national, parallel arm prospective randomized open-label, blinded endpoint (PROBE) controlled trial enrolling patients at six European medical centres. We randomized 1,537 older medical and surgical patients with multi-morbidity and polypharmacy on admission in a 1:1 ratio to SENATOR software-guided medication optimization plus standard care (intervention, n = 772, mean number of daily medications = 9.34) or standard care alone (control, n = 765, mean number of daily medications = 9.23) using block randomization stratified by site and admission type. Attending clinicians in the intervention arm received SENATOR-generated advice at a single time point with recommendations they could choose to adopt or not. The primary endpoint was occurrence of probable or certain ADRs within 14 days of randomization. Secondary endpoints were primary endpoint derivatives; tertiary endpoints included all-cause mortality, re-hospitalization, composite healthcare utilization and health-related quality of life. Results For the primary endpoint, there was no difference between the intervention and control groups (24.5 vs. 24.8%; OR 0.98; 95% CI 0.77–1.24; P = 0.88). Similarly, with secondary and tertiary endpoints, there were no significant differences. Among attending clinicians in the intervention group, implementation of SENATOR software-generated medication advice points was poor (~15%). Conclusions In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.

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“…By applying the STOPP and START criteria, the software produces a report which outlines possible drug-drug and drug-disease interactions and provides non-pharmacological recommendations aimed at reducing the risk of incident delirium. The primary endpoint of the study was to evaluate the percentage of patients with at least one probable or certain ADR occurring within 14 days of enrolment during the hospitalization period [74][75][76]. Unfortunately, the trial failed to show a significant impact in reducing the incidence of ADRs and the level of adherence by medical staff to the intervention was relatively low [77].…”

Section: Softwarementioning

confidence: 99%

Adverse drug reactions in older adults: a narrative review of the literature

et al. 2021

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Purpose Adverse drug reactions (ADRs) represent a common and potentially preventable cause of unplanned hospitalization, increasing morbidity, mortality, and healthcare costs. We aimed to review the classification and occurrence of ADRs in the older population, discuss the role of age as a risk factor, and identify interventions to prevent ADRs. Methods We performed a narrative scoping review of the literature to assess classification, occurrence, factors affecting ADRs, and possible strategies to identify and prevent ADRs. Results Adverse drug reactions (ADRs) are often classified as Type A and Type B reactions, based on dose and effect of the drugs and fatality of the reaction. More recently, other approaches have been proposed (i.e. Dose, Time and Susceptibility (DoTS) and EIDOS classifications). The frequency of ADRs varies depending on definitions, characteristics of the studied population, and settings. Their occurrence is often ascribed to commonly used drugs, including anticoagulants, antiplatelet agents, digoxin, insulin, and non-steroidal anti-inflammatory drugs. Age-related factors—changes in pharmacokinetics, multimorbidity, polypharmacy, and frailty—have been related to ADRs. Different approaches (i.e. medication review, software identifying potentially inappropriate prescription and drug interactions) have been suggested to prevent ADRs and proven to improve the quality of prescribing. However, consistent evidence on their effectiveness is still lacking. Few studies suggest that a comprehensive geriatric assessment, aimed at identifying individual risk factors, patients’ needs, treatment priorities, and strategies for therapy optimization, is key for reducing ADRs. Conclusions Adverse drug reactions (ADRs) are a relevant health burden. The medical complexity that characterizes older patients requires a holistic approach to reduce the burden of ADRs in this population.

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The effect of SENATOR (Software ENgine for the Assessment and optimisation of drug and non-drug Therapy in Older peRsons) on incident adverse drug reactions (ADRs) in an older hospital cohort – Trial Protocol

Cited by 27 publications

References 28 publications

Potential prescribing omissions of medications in older adults based on START version 2 criteria in a tertiary Jordanian teaching hospital

Potential prescribing omissions of medications in older adults based on START version 2 criteria in a tertiary Jordanian teaching hospital

Prevention of adverse drug reactions in hospitalized older patients with multi-morbidity and polypharmacy: the SENATOR* randomized controlled clinical trial

Adverse drug reactions in older adults: a narrative review of the literature

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