An observational study in Quality of Care, Evaluation and Emergency Department, sponsored by Mario Negri Institute for Pharmacological Research. Recruiting at 7 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Mario Negri Institute for Pharmacological Research · Observational
The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients.
The information normally recorded in the Emergency Department medical record will be used, as well as the available clinical and administrative databases. For reasons of feasibility, the investigators will also restrict the analysis to patients coming to the Emergency Department with non-specific manifestations in the pulmonary, cardiovascular and abdominal districts, represented by one or more of the following symptoms: dyspnoea, chest pain, transient loss of consciousness, abdominal pain.
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's planned enrollment of 240,000 is above the median of 353 across 714 observational studies indexed under Emergencies.
Browse Emergencies studies →Mario Negri Institute for Pharmacological Research is the lead sponsor of 159 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients aged 18 years and over who arrived at participating centres between 1 January 2023 and 31 December 2024.
All patients aged 18 years and over who arrived at participating centres between 1 January 2023 and 31 December 2024.
Exclusion Criteria:
All patients under 18 years of age arriving at participating centers between January 1, 2023 and December 31, 2024 and all patients arriving at participating centers outside the time frame January 1, 2023 - December 31, 2024.
All patients aged 18 years and over who arrived at participating centres between 1 January 2023 and 31 December 2024.
Qualitative validation and first refinement of the classification algorithm
In this first phase of the project, representatives of doctors and nurses from participating hospitals will be asked to express their opinion on content validity. This refers to the accuracy with which a measurement tool covers all aspects of the construct under examination. Its measurement is generally based on the judgment of experts in the field, who are asked to provide feedback on how closely the measurement tool corresponds to the different domains associated with the construct. The evaluation will be conducted according to the consensus conference approach, an approach that reduces the risk of excessive subjectivity, intrinsic to content validity. This evaluation will lead to a possible refinement of the individual criteria that make up the algorithm.
Time frame: From August 2025 to November 2025
Quantitative validation and second refinement of the classification algorithm
In this second phase, the criterion validity of the algorithm developed in the previous phase will be examined. Criterion validity measures the relationship between the results obtained with the test in question and those obtained with a consolidated reference standard (the criterion, or gold standard) that measures the same construct.
Time frame: From September 2025 to October 2026
Application of the algorithm to all eligible patients
Once perfected, the algorithm will be applied to all eligible patients arriving at the ER of participating hospitals within a 24-month period (from January 2023 to December 2024). This means that, for all hospitalized patients, it will be possible to obtain data on the appropriateness of this choice and monitor the evolution of this data over time.
Time frame: From November 2026 to Dicember 2026
Feasibility of assessing the appropriateness of discharge from the emergency room
In this phase, an attempt will be made to obtain the data necessary to evaluate the appropriateness of discharges from the ED for eligible patients who were discharged between January 2023 and December 2024. Data will be collected on all accesses in the period considered in order to identify any multiple patient accesses (return visits) and the related presentation tables.
Time frame: From November 2026 to June 2027
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mario Negri Institute for Pharmacological Research