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Computerized decision support systems. Do personalized guidelines help physicians in the decision-making process? Two important clinical trials carried out in Italy are going to find it out.

It is not uncommon for treatment guidelines to be considered vague and not very adherent to clinical practice. Today, however, thanks to technology developments and the adoption of electronic health records in hospitals, clinicians can easily access patient-specific guidance messages based on best evidence. Two large clinical trials conducted in Italy investigate the usefulness of computerized decision support systems for health care professionals.

Until recent years, supporting medical decisions through computerized evidence-based systems integrated with electronic health records was an almost unexplored hypothesis in Italy. Today, two randomized clinical trials prove to be highly feasible, throwing some light on the usefulness of these tools in improving delivered care quality.

Nothing more than a simple button on the hospital medical record; just press it, and all scientific literature available comes to the aid of clinicians in dealing with patients. The decision support software can provide a well-organized synthesis of drug interactions as well as suggestions concerning dosage or therapy adjustments by only examining in a few seconds thousands of cloud-based documents, trials, systematic reviews, and guidelines. Moreover, it can check diagnoses, therapies, and therapeutic monitoring in real time, thereby reporting possible inconsistencies. A prompt and reliable “second opinion” able to point out, for instance, that a given patient may successfully respond to a drug other than the one prescribed by the doctor; a possibility of which the physician might hardly have been aware, unless he/she had regularly referred to the worldwide scientific literature regarding that certain medicine and patient typology.

The CODES research programme assesses the effectiveness of computerized decision support systems (CDSSs) for health care professionals. Co-funded by the Ministry of Health and Region of Lombardy and carried out by a multidisciplinary researchers’ group, it is the first project of this nature in Italy as well as one of the most remarkable experiences on a global scale when it comes to sample size. Within the project framework, two clinical trials are currently being implemented at the hospital of Vimercate and IRCCS IRTS of Meldola, which is the Oncology Institute of reference in Romagna. Both facilities are equipped with a highly advanced technological infrastructure; here wards are endowed with fully codified electronic health records allowing integration with the decision support system. So far, these two trials have randomized more than ten thousand patients, yet researchers aim to enroll more than twice that number, thereby achieving a prominent place in the international landscape of large clinical trials active in this field.

“CDSSs are software able to help physicians and health care professionals in the decision-making process concerning patients’ care, since they provide a reliable second opinion based on best evidence available in scientific literature,” explains Lorenzo Moja, Project Manager and Researcher at Università degli Studi, in charge of the Clinical Epidemiology Unit of IRCCS Galeazzi Orthopaedic Institute in Milan. “The most advanced CDSS models integrate with electronic health records allowing associations between patient-related data and information coming from the main international biomedical databases, thereby returning individually tailored instructions based on best evidence in the form of guidance messages.”

Until recently, issues concerning access to CDSSs, procedures of technology integration and its diffusion among clinicians, and all preliminary aspects connected with contract and coordination conditions needed to implement ICT systems within and without hospitals were merely unspecific future topics. The same applies to the hypothesis of tool usefulness checking. “Although this kind of support has been included for some time now in the most potentially effective measures for the promotion of professional conduct appropriateness and clinical practice quality, thereby fostering health systems improvement, and despite some significant episodes recorded abroad, no Italian hospital had reported direct experience of it until a few months ago,” points out Oriana Nanni, Director of the Biostatistics Unit and Clinical Trials at IRCCS IRST in Meldola.

These two trials have enabled two Italian hospitals, characterized by a different vocation but similar growing ICT and organizational development, to provide clinicians with an advanced health navigator. “The system elaborates diagnoses, therapies, and drug interactions, and offers suggestions to improve organizational efficiency; a real comprehensive support,” adds IIkka Kunnamo, Editor in Chief of EBM Guidelines, the software produced by Duodecim Medical Publications Ltd., the publishing company of Finnish physicians from which MediDSS, the Italian version used in the CODES trials, originates.

CDSS integration is the most difficult step to be implemented in the framework of hospital ICT equipment, as it calls for the full integration of all data on care and health services delivered, mapped and made available outside hospitals, which in turn integrate with other international databases. “CDSSs represent full care internationalization in local contexts. Today, less than 1% of the European hospitals succeed in managing data and information to the advantage of clinical practice. Still, a general adaptation process will be necessary within national health systems in the coming years,” concludes Hernan Polo Friz, Specialist in Internal Diseases at the hospital of Vimercate.

The first outcome achieved by the CODES study is precisely to have placed two Italian hospitals among the most developed European facilities as far as technology equipment and the daily application of best scientific evidence are concerned.

Francesca Ruggiero
Università degli Studi di Milano