Validating a Trigger Tool for Detecting Adverse Drug Events in Elderly Patients With Multimorbidity (TRIGGER-CHRON).

PURPOSE: The aims of the study were to evaluate the performance of an initial list developed to detect adverse drug events (ADEs) in elderly patients with multimorbidity in clinical practice, to explore the possibility of shortening the list, and to use this tool to study the incidence and characteristics of the ADEs among this population. METHODS: This observational study was conducted at 12 Spanish hospitals. A random sample of five charts from each hospital was selected weekly for retrospective review for a 12-week period. We included patients aged 65 years and older with multimorbidity, hospitalized more than 48 hours. Adverse drug events were detected using a list of 51 triggers previously selected by an expert panel by means of a modified Delphi method. The number of triggers identified and ADEs detected were recorded. The severity and preventability of the ADEs were evaluated. The positive predictive value (PPV) of each trigger was calculated and used to select the most efficient triggers. RESULTS: In 720 charts reviewed, 1430 positive triggers were identified that led to detect 215 ADEs in 178 patients (24.7%), of which 13% were serious. One hundred nineteen ADEs (55.3%) were preventable and mainly related to inadequate treatment monitoring and prescribing errors. Triggers with a PPV of 5% or less were eliminated, resulting in a final list of 32 triggers (TRIGGER-CHRON) with a PPV of 22.1%, which accounted for 98.9% of all ADEs detected and 98.6% of the preventable ADEs. CONCLUSIONS: The shorter final validated TRIGGER-CHRON tool is an efficient list for identifying ADEs in elderly patients with multimorbidity, detecting ADEs in one-fourth of hospitalized patients in internal medicine or geriatric units.

[Methodological guideline for the efficacy and safety assessment of new pharmaceuticals: implementation of EUnetHTA's recommendations]. / Guía metodológica para la evaluación de la eficacia y la seguridad de nuevos fármacos: implementación de las recomendaciones de EUnetHTA.

The European network for Health Technology Assessment (EUnetHTA) is the network of public health technology assessment (HTA) agencies and entities from across the EU. In this context, the HTA Core Model®, has been developed. The Andalusian Agency for Health Technology Assessment (AETSA) is a member of the Spanish HTA Network and EUnetHTA collaboration In addition, AETSA participates in the new EUnetHTA Joint Action 3 (JA, 2016-2019). Furthermore, AETSA works on pharmaceutical assessments. Part of this work involves drafting therapeutic positioning reports (TPRs) on drugs that have recently been granted marketing authorisation, which is overseen by the Spanish Agency of Medicines and Medical Devices (AEMPS). AETSA contributes by drafting "Evidence synthesis reports: pharmaceuticals" in which a rapid comparative efficacy and safety assessment is performed for drugs for which a TPR will be created. To create this type of report, AETSA follows its own methodological guideline based on EUnetHTA guidelines and the HTA Core Model®. In this paper, the methodology that AETSA has developed to create the guideline for "Evidence synthesis reports: pharmaceuticals" is described. The structure of the report itself is also presented.