Principi di Risk Management nei servizi sanitari casi metodologie, applicazioni, possibili sviluppi

CLINICAL RISK MANAGEMEN

A Trust-Based Pact in Research Biobanks. From Theory to Practice

Traditional Informed Consent is becoming increasingly inadequate, especially in the context of research biobanks. How much information is needed by patients for their consent to be truly informed? How does the quality of the information they receive match up to the quality of the information they ought to receive? How can information be conveyed fairly about future, non-predictable lines of research? To circumvent these difficulties, some scholars have proposed that current consent guidelines should be reassessed, with trust being used as a guiding principle instead of information. Here, we analyse one of these proposals, based on a Participation Pact, which is already being offered to patients at the Istituto Europeo di Oncologia, a comprehensive cancer hospital in Milan, Italy

Clinical Assessment of Risk Management: an INtegrated Approach (CARMINA)

Purpose \u2013 The European Union recommendations for patient safety calls for shared clinical risk management (CRM) safety standards able to guide organizations in CRM implementation. The purpose of this paper is to develop a self-evaluation tool to measure healthcare organization performance on CRM and guide improvements over time. Design/methodology/approach \u2013 A multi-step approach was implemented including: a systematic literature review; consensus meetings with an expert panel from eight Italian leader organizations to get to an agreement on the first version; field testing to test instrument feasibility and flexibility; Delphi strategy with a second expert panel for content validation and balanced scoring system development. Findings \u2013 The self-assessment tool \u2013 Clinical Assessment of Risk Management: an INtegrated Approach includes seven areas (governance, communication, knowledge and skills, safe environment, care processes, adverse event management, learning from experience) and 52 standards. Each standard is evaluated according to four performance levels: minimum; monitoring; outcomes; and improvement actions, which resulted in a feasible, flexible and valid instrument to be used throughout different organizations. Practical implications \u2013 This tool allows practitioners to assess their CRM activities compared to minimum levels, monitor performance, benchmarking with other institutions and spreading results to different stakeholders. Originality/value \u2013 The multi-step approach allowed us to identify core minimum CRM levels in a field where no consensus has been reached. Most standards may be easily adopted in other countries

Analisi del rischio clinico del percorso del paziente in un centro di radioterapia avanzata mediante metodologia F.M.E.A.

Starting from the increasing requirement of efficient access to healthcare, the study aims to assess the current standard procedures in order to optimize safety and quality.The decision to study the patient's process in Radiotherapy (RT) by FMEA methodology (Failure Mode and Effect Analysis), in order to identify and manage the risks for patients, arose from an interest of both the Radiotherapy Division and the Management of the European Institute of Oncology (IEO) IRCSS of Milan (Italy) in consideration of its high activity and of the volume of patients treated. The department has undergone a remarkable change in the last seven years, by increasing the number of accelerators and the number of patients treated, which rose from 2.197 (2011) to 3.194 (2017).Treatment modalities and timing of each session have changed: nowadays the majority of the patients receive highly complex treatments (intensity-modulated radiotherapy, image-guided radiotherapy, stereotactic radiotherapy, etc.).PurposeThe purpose of this study is to define an instrument of practical use and maintenance, for the proactive management of clinical risk by analysing the patient’s care path in RT: from his medical examination to the discharge and the next follow-up visits.The instrument was tested by handing it out to employees in the form of a questionnaire, trying to involve a significant pool of professionals.Materials and methodsStarting from previous Institutional experiences of FMEA studies in other clinical areas, we decided to:make-up several multidisciplinary working groups (with one or two members of each professional level) in order to define the sub-processes, the failure mode and the impact of potential damage.propose the participation of radiotherapy professionals in defining the frequency of the failure mode in their experience, using questionnaires and scales of predefined values.To define the value "potential damage" and the attribution of the frequency of occurrence of the various failure modes, we sought to minimize a potentially non-voluntary effect of mitigating the risk due to the awareness of the correlations between frequency of occurrence and damage.Therefore, the professionals involved were not aware of the results.ResultsThe study was carried out with great participation from the professionals involved in the patient's path (88,6% of the staff involved in the study responded to the questionnaires administered in the first part of the study; 69,7% was the rate of participation in the second part). This result allowed to overcome the subjective limitations due to the low numerical representation and the lack of objective epidemiological data concerning the near miss. Forty-four criticalities were found (14% of all the failure) and required intervention planning.ConclusionThis work led to the definition of a model with analytical description and quantification of the clinical risk for all the failure modes by "Risk Priority Number" (RPN) of all the sub-processes of the patient's path. Starting from the significant result of the areas requiring intervention, we could identify several improvement actions to reduce clinical risk. The model allows a dynamic management of clinical risk linked to a specific process and it could be exported to other Radiotherapy Centers.Lo studio nasce dalla volontà di garantire costantemente elevati standard di sicurezza e qualità delle cure in uno scenario di incremento della domanda sanitaria che richiede, anche, mantenimento di processi produttivi efficienti.La decisione di studiare il processo del paziente in Radioterapia mediante la metodologia FMEA (Failure Mode and Effect Analysis) al fine di identificare e gestire i rischi per i pazienti è scaturita da un interesse della Divisione di Radioterapia e del Management dell’Istituto Europeo di Oncologia (IEO) IRCCS di Milano in considerazione degli alti volumi di attività: il reparto ha subito una notevole trasformazione nel corso degli ultimi sette anni, aumentando il numero di acceleratori ed il numero di pazienti trattati, passando da 2.197 (2011) a 3.194 (2017).Sono cambiate le modalità di terapia e le tempistiche di ogni seduta, infatti la maggior parte dei pazienti attuali riceve trattamenti di alta complessità (radioterapia a intensità modulata, radioterapia guidata dalle immagini, radioterapia stereotassica, etc.).Obiettivo dello studioLo scopo di questo lavoro è definire uno strumento di pratico utilizzo e manutenzione per la gestione proattiva del rischio clinico, mediante l’analisi dell’intero percorso radioterapico del paziente: dalla sua prima visita medica sino alla dimissione e successivi follow-up; e testarlo somministrandolo, sotto forma di questionario, ai dipendenti, cercando di coinvolgere rappresentanze numericamente significative di professionisti.Materiali e metodiFacendo tesoro di altre esperienze di studi FMEA già condotti in Istituto in altri ambiti, si è deciso di:costituire più gruppi di lavoro multidisciplinare (con uno o due componenti di ogni professione) al fine di definire i sotto-processi, i modi di errore e l’entità del danno potenziale.proporre a tutti i professionisti sanitari della radioterapia la partecipazione alla definizione della frequenza dei modi di errore nel loro vissuto, utilizzando questionari e scale di valori predefinite.Per la definizione del valore “danno” e l’attribuzione della frequenza ponderata di accadimento dei vari Failure mode si è voluto evitare l’effetto, potenzialmente involontario, di mitigazione del rischio dovuto alla presa di consapevolezza delle correlazioni tra frequenza di accadimento e danno.I professionisti coinvolti non erano a conoscenza dei risultati ottenuti.RisultatiLo studio è stato effettuato con una partecipazione ampia dei professionisti coinvolti nel percorso del paziente (88,6% del personale coinvolto nello studio ha risposto ai questionari somministrati nella prima parte dello studio; il 69,7%, invece, è stato il tasso di partecipazione nella seconda parte dello studio), consentendo quindi di superare i limiti soggettivi dovuti alla scarsa rappresentatività numerica dei professionisti solitamente coinvolti ed alla mancanza di dati statistici oggettivi sui near miss. Sono state individuate 44 criticità (14% di tutti i Failure studiati) che richiedono la pianificazione di intervento.ConclusioniIl lavoro ha portato alla definizione di un modello con analitica descrizione e quantificazione del rischio clinico per tutti i modi di errore mediante un “Risk Priority Number” (RPN) di tutti i sotto-processi del percorso del paziente, dal quale emerge che le aree di criticità che necessitano di un intervento sono ridotte. Sono state individuate diverse azioni di miglioramento per ridurre il rischio clinico. Il modello consente una gestione dinamica nel tempo del rischio clinico legato ad un determinato processo e trasferibile presso altre radioterapie

Clinical risk analysis of the patient’s path in an Advanced Radiotherapy Center (A.R.C.) through F.M.E.A. method

Starting from the increasing requirement of efficient access to healthcare, the study aims to assess the current standard procedures in order to optimize safety and quality.The decision to study the patient's process in Radiotherapy (RT) by FMEA methodology (Failure Mode and Effect Analysis), in order to identify and manage the risks for patients, arose from an interest of both the Radiotherapy Division and the Management of the European Institute of Oncology (IEO) IRCSS of Milan (Italy) in consideration of its high activity and of the volume of patients treated. The department has undergone a remarkable change in the last seven years, by increasing the number of accelerators and the number of patients treated, which rose from 2.197 (2011) to 3.194 (2017).Treatment modalities and timing of each session have changed: nowadays the majority of the patients receive highly complex treatments (intensity-modulated radiotherapy, image-guided radiotherapy, stereotactic radiotherapy, etc.).PurposeThe purpose of this study is to define an instrument of practical use and maintenance, for the proactive management of clinical risk by analysing the patient’s care path in RT: from his medical examination to the discharge and the next follow-up visits.The instrument was tested by handing it out to employees in the form of a questionnaire, trying to involve a significant pool of professionals.Materials and methodsStarting from previous Institutional experiences of FMEA studies in other clinical areas, we decided to:make-up several multidisciplinary working groups (with one or two members of each professional level) in order to define the sub-processes, the failure mode and the impact of potential damage.propose the participation of radiotherapy professionals in defining the frequency of the failure mode in their experience, using questionnaires and scales of predefined values.To define the value "potential damage" and the attribution of the frequency of occurrence of the various failure modes, we sought to minimize a potentially non-voluntary effect of mitigating the risk due to the awareness of the correlations between frequency of occurrence and damage.Therefore, the professionals involved were not aware of the results.ResultsThe study was carried out with great participation from the professionals involved in the patient's path (88,6% of the staff involved in the study responded to the questionnaires administered in the first part of the study; 69,7% was the rate of participation in the second part). This result allowed to overcome the subjective limitations due to the low numerical representation and the lack of objective epidemiological data concerning the near miss. Forty-four criticalities were found (14% of all the failure) and required intervention planning.ConclusionThis work led to the definition of a model with analytical description and quantification of the clinical risk for all the failure modes by "Risk Priority Number" (RPN) of all the sub-processes of the patient's path. Starting from the significant result of the areas requiring intervention, we could identify several improvement actions to reduce clinical risk. The model allows a dynamic management of clinical risk linked to a specific process and it could be exported to other Radiotherapy Centers.Starting from the increasing requirement of efficient access to healthcare, the study aims to assess the current standard procedures in order to optimize safety and quality.The decision to study the patient's process in Radiotherapy (RT) by FMEA methodology (Failure Mode and Effect Analysis), in order to identify and manage the risks for patients, arose from an interest of both the Radiotherapy Division and the Management of the European Institute of Oncology (IEO) IRCSS of Milan (Italy) in consideration of its high activity and of the volume of patients treated. The department has undergone a remarkable change in the last seven years, by increasing the number of accelerators and the number of patients treated, which rose from 2.197 (2011) to 3.194 (2017).Treatment modalities and timing of each session have changed: nowadays the majority of the patients receive highly complex treatments (intensity-modulated radiotherapy, image-guided radiotherapy, stereotactic radiotherapy, etc.).PurposeThe purpose of this study is to define an instrument of practical use and maintenance, for the proactive management of clinical risk by analysing the patient’s care path in RT: from his medical examination to the discharge and the next follow-up visits.The instrument was tested by handing it out to employees in the form of a questionnaire, trying to involve a significant pool of professionals.Materials and methodsStarting from previous Institutional experiences of FMEA studies in other clinical areas, we decided to:make-up several multidisciplinary working groups (with one or two members of each professional level) in order to define the sub-processes, the failure mode and the impact of potential damage.propose the participation of radiotherapy professionals in defining the frequency of the failure mode in their experience, using questionnaires and scales of predefined values.To define the value "potential damage" and the attribution of the frequency of occurrence of the various failure modes, we sought to minimize a potentially non-voluntary effect of mitigating the risk due to the awareness of the correlations between frequency of occurrence and damage.Therefore, the professionals involved were not aware of the results.ResultsThe study was carried out with great participation from the professionals involved in the patient's path (88,6% of the staff involved in the study responded to the questionnaires administered in the first part of the study; 69,7% was the rate of participation in the second part). This result allowed to overcome the subjective limitations due to the low numerical representation and the lack of objective epidemiological data concerning the near miss. Forty-four criticalities were found (14% of all the failure) and required intervention planning.ConclusionThis work led to the definition of a model with analytical description and quantification of the clinical risk for all the failure modes by "Risk Priority Number" (RPN) of all the sub-processes of the patient's path. Starting from the significant result of the areas requiring intervention, we could identify several improvement actions to reduce clinical risk. The model allows a dynamic management of clinical risk linked to a specific process and it could be exported to other Radiotherapy Centers

Rationale and design of the CV-PREVITAL study: an Italian multiple cohort randomised controlled trial investigating innovative digital strategies in primary cardiovascular prevention

Introduction Prevention of cardiovascular disease (CVD) is of key importance in reducing morbidity, disability and mortality worldwide. Observational studies suggest that digital health interventions can be an effective strategy to reduce cardiovascular (CV) risk. However, evidence from large randomised clinical trials is lacking.Methods and analysis The CV-PREVITAL study is a multicentre, prospective, randomised, controlled, open-label interventional trial designed to compare the effectiveness of an educational and motivational mobile health (mHealth) intervention versus usual care in reducing CV risk. The intervention aims at improving diet, physical activity, sleep quality, psycho-behavioural aspects, as well as promoting smoking cessation and adherence to pharmacological treatment for CV risk factors. The trial aims to enrol approximately 80 000 subjects without overt CVDs referring to general practitioners’ offices, community pharmacies or clinics of Scientific Institute for Research, Hospitalization and Health Care (Italian acronym IRCCS) affiliated with the Italian Cardiology Network. All participants are evaluated at baseline and after 12 months to assess the effectiveness of the intervention on short-term endpoints, namely improvement in CV risk score and reduction of major CV risk factors. Beyond the funded life of the study, a long-term (7 years) follow-up is also planned to assess the effectiveness of the intervention on the incidence of major adverse CV events. A series of ancillary studies designed to evaluate the effect of the mHealth intervention on additional risk biomarkers are also performed.Ethics and dissemination This study received ethics approval from the ethics committee of the coordinating centre (Monzino Cardiology Center; R1256/20-CCM 1319) and from all other relevant IRBs and ethics committees. Findings are disseminated through scientific meetings and peer-reviewed journals and via social media. Partners are informed about the study’s course and findings through regular meetings.Trial registration number NCT05339841