This thesis project is the main part of my personal contribution given during the internship carried out in the Department of Clinical Engineering at Santagostino medical centre, started in February 2022 and currently ongoing. The thesis work represents a final milestone for my Master of Science degree in Biomedical Engineering (Clinical Engineering track) at Politecnico di Milano. Centro Medico Santagostino was founded in 2009 with the objective to cover the growing needs of a large catchment area of patients: high quality medical services combined with the possibility to have an easy access to the available services thanks to fair prices. To date CMS counts 32 centres, the highest majority of them located in Milan and its hinterland: in the meanwhile, an increasing interest is pushing toward new openings located in Rome and Bologna. The pillars for value generation in Santagostino are represented by a weighted sum that accounts for innovation, short-time accessibility, transparency based on real data and, last but not least, the care toward the final user of any medical service here in Santagostino: the CMS clinics offer the possibility of performing medical examination over 73 different branches. For the purpose of this project, it has been carried out a Health Technology Assessment for the evaluation of the clinical effectiveness of an innovative Dual Energy X-ray Absorptometer, considered as a standard typology of examination for the diagnosis of osteoporosis and other endocrinologic diseases. Finally, a Multi Criteria Decision Analysis has been performed in order to attribute a score to the technologies that were under the assessment. With the choice of the new machine, a subsequent on-site installation and technology configuration in “Panfilo Castaldi” centre was taken out. Of course, with the objective to permit an optimization of wasting time and associated costs related to the company, it was scheduled an operating plan before the installation of the new DEXA technology. Moreover, a training of the technical and medical personnel was carried out to ensure a correct workflow for the exam execution, and consequently a production of a valuable report. Physicians, also, were trained with the aim to provide guidelines on the correct use of threshold values for the discrimination among different physio pathological conditions. Osteoporosis is an emerging medical and socioeconomic threat characterised by a systemic impairment of bone mass, strength, and microarchitecture, which increases the propensity of fragility fractures. It affects more than 75 million people in Europe, Japan and the USA, and causes more than 2.3 million fractures annually in Europe and the USA alone. Osteoporosis does not only cause fractures, it also causes people to become bedridden with secondary complications that may be life threatening in the elderly. Assessment of bone mass, mostly termed as Bone Mineral Density (BMD) is the standard method for the definition of a diagnostic approach for an osteoporotic fracture risk evaluation. An expert panel of the World Health Organization (WHO) recommended thresholds to divide among different categories of patient at risk of osteoporosis and proposed the DXA examination at the hip as the standard technology for the evaluation of an osteoporotic condition. Specialists in endocrinology, supported by the clinical opinion of the CMS health director, have presented, as a project for the new clinical offering for 2022, the intention to introduce newer technologies in the field of densitometry. The clinical requirement to be satisfied were concerned about the introduction of innovative software for the execution of textural measurements, in order to acquire information not only about bone quantity, but also regarding bone quality microarchitecture and applied loads. For these reasons, software integration was considered as a target tool to be adopted in this innovation. Textural parameters such as BMD and TBS provide useful information about bone quantity and bone quality, respectively, but detailed information about geometry and load definition are still missing. Recently, it has been developed a bone FEM analysis on DXA images named Bone Strain Index (BSI), in order to take into account bone strength features in the prediction of a fracture risk. Bone Strain Index automatically calculates strains and stresses in a bone segment, starting from a specific loading condition, defined specifically for each patient. It is based on finite element algorithms usually used in engineering applications. A Mini HTA was carried out in order to perform an assessment of the consequences after the introduction of the new technology from different points of view: being a complete private reality that is experiencing a swift growth, it was necessary to undertake a short timeframe and a limited resources analysis. In particular technical (TEC), clinical effectiveness (EFF), organizational (ORG) and economic domains (ECO) were analyzed to order to produce indications for the final decision-making process. The use of DALYs or QALYs as outcomes within cost-utility analyses to determine the health status presents some limitations: for the aims of this project, generic summary measures on only the clinical improvement with respect to a standard technology may be overly simplistic and reductionist and may not be capturing all of the benefits of this intervention, since other aspects related to TEC and ORG domains should be taken into account. That’s why multi-criteria decision analysis (MCDA) method aimed to facilitate the identification of the best possible solution. A pseudo Best-Worst Scaling method was used for our purposes. Therefore, the target solution was in this way identified as the Hologic proposal, with its Horizon Ci technology. Apart from the technical aspects, the skills that were needed to actualize this project from the managerial, operative and economic point of view were never acquired before in my professional experience. Being the owner of a project means to have the responsibility to guide the entire workflow towards an effective, efficient and valuable management: the description of the clinical and technical features, to be presented then to the clinical audience, has been only one of the responsibilities for a global satisfaction. In fact, a precise time-based schedule of all the activities was necessary in order then to combine all the actors take took part in this process: the preventive communication with internal and external figures of CMS allowed to actualize the project without many bottlenecks, prone to happen in case of an incorrect management of the preoperative activities to be prepared. After the acceptance of the economic offer, it was requested a schedule for the on-site installation, configuration and training of the Technical personnel days. In this final part, it was actualized all the operative plan previously scheduled. Program included the On-site installation of the new health technology, BMD and TBS calibration, configuration of the machine and testing. Also, a daily agenda was opened during the installation days for allowing technical personnel training. Finally, it was scheduled a webinar with CMS specialists in the field of radiology and endocrinology, with the aim to inform them about the correct use of BMD, TBS and BSI threshold according to official guidelines, in order to interpret in a standardized manner any real case study under examination.
Questo Progetto tesi rappresenta la parte principale del mio contributo personale dato durante il tirocinio svolto nel Dipartimento di Ingegneria Clinica, presso il Centro Medico Santagostino (CMS), iniziato nel febbraio 2022 e tutt’ora in corso. Questo lavoro di tesi costituisce l’ultima pietra miliare per il mio percorso di Laurea Magistrale in Ingegneria Biomedica (ramo Ingegneria Clinica) al Politecnico di Milano. Il Centro Medico Santagostino fu fondato nel 2009 con l’obiettivo di coprire le necessità crescenti di un ampio bacino di pazienti: servizi medici di qualità combinati con la possibilità di averne accesso grazie a prezzi calmierati. Ad oggi CMS conta di 32 centri, la maggior parte di essi presenti sul territorio di Milano e hinterland: nel mentre, un interesse crescente continua a spingere verso le nuove aperture di Roma e Bologna. I pilastri per la generazione del valore all’ interno del Santagostino sono rappresentati da una somma pesata che tiene in considerazione di innovazione, accessibilità in tempi ridotti, trasparenza basata su dati reali e, ultimo ma non ultimo, la cura verso l’utente finale riguardo ogni prestazione erogata qui al Santagostino: CMS offre la possibilità di eseguire prestazioni mediche per oltre 73 specialità. Per gli obietti di questo progetto, è stato condotto un Health Technology Assessment (HTA) per la valutazione dell’efficacia clinica di una nuova macchina per Assorbimetria a raggi X a doppia energia, considerato come una tipologia di esame standard per la diagnosi di osteoporosi e altre malattie endocrinologiche. In ultimo, è stata condotta una Multi-Criteria Decision Analsys (MCDA) con l’obiettivo di attribuire un punteggio alle tecnologie che erano sotto esame. Con la scelta della nuova macchina, sono state effettuate operazioni di installazione e configurazione presso il centro di “Panfilo Castaldi”. Ovviamente, con l’obiettivo di permettere un’ottimizzazione dei tempi e dei costi associati per la compagnia, è stato schedulato un piano operativo prima dell’installazione della nuova tecnologia DEXA. Inoltre, è stata condotta una formazione sul personale tecnico e medico per far sì che la procedura di esecuzione esame venisse effettuata secondo un workflow corretto, al fine di produrre un report di valore per la refertazione medica. Inoltre, sono stati formati anche gli specialisti, con l’obiettivo di fornir loro linee guida per un corretto utilizzo di valori soglia per il discernere tra differenti condizioni fisio-patologiche associate ai diversi soggetti sotto esame. L’osteoporosi è una minaccia emergente dal punto di vista medico e socioeconomico, caratterizzata da uno squilibrio sistemico di variabili come massa, forza, e microarchitettura associate al tessuto osseo, con un conseguente incremento del rischio di fratture da fragilità. La malattia colpisce più di 75 milioni di persone in Europa, Giappone e USA, e causa più di 2.3 milioni di fratture in un anno in Europa e Stati Uniti soltanto. L’osteoporosi non causa solo danni da fratture, ma provoca l’allettamento del paziente, con conseguente insorgenza di complicazioni secondarie che potrebbero essere dannose durante la vecchiaia. La valutazione della massa ossea, quindi il calcolo della Bone Mineral Density (BMD), rappresenta un metodo standard per la definizione di un approccio diagnostico ai fini della valutazione del rischio di frattura da osteoporosi. Un panel di esperti della World Health Organization (WHO) ha reso disponibili i valori soglia per la suddivisione tra diverse categorie di pazienti a rischio di osteoporosi, e ha identificato l’esame DEXA all’anca come la tecnologia standard per la valutazione di una condizione osteoporotica. Specialisti in endocrinologia, supportati dall’opinione clinica del direttore sanitaria del centro medico, hanno presentato, come progetto per la Nuova Offerta clinica del 2022, l’intenzione di introdurre tecnologie ancora più innovative nel mondo della densitometria ossea. Il requisito clinico da soddisfare era improntato sull’introduzione di software innovativi per il calcolo di parametri di texture dell’immagine, in modo tale da acquisire informazioni non solo sulla quantità di osso, ma sulla qualità della microarchitettura ossea, e sugli sforzi meccanici applicati. Per queste ragioni, l’integrazione software è stata considerata come lo strumento di target da adottare con questa innovazione tecnologica. Parametri di texture come BMD e TBS forniscono informazioni utili riguardo qualità e quantità dell’osso, mancando però di specificazioni riguardo geometria e carichi applicati sull’osso. Recentemente, è stata sviluppata un’analisi ad elementi finiti applicata all’immagine DEXA, il cui software è chiamato Bone Strain Index (BSI), per far sì che vengano prese in considerazione variabili di sforzo nella predizione del rischio di frattura. BSI calcola automaticamente sforzi e deformazioni nel segmento osseo, a partire da una condizione specifica di carico, definita univocamente per ogni paziente. Il software è basato su algoritmi di FEM utilizzati spesso per applicazioni ingegneristiche. E’ stato condotto mini HTA per effettuare una valutazione delle conseguenze dopo l’introduzione della nuova tecnologia, sotto diversi punti di vista: essendo completamente una realtà privata che vive un percorso di rapida crescita, è stato necessario effettuare un’analisi con time window e risorse limitati. In particolare, i domini riguardanti l’aspetto tecnico (TEC), l’efficacia clinica (EFF), l’organizzazione (ORG) e l’analisi economica (ECO) sono stati analizzati al fine di produrre indicazioni per un processo di Decision Making finale. L’utilizzo di QALY o DALY come outcome nell’analisi costo utilità per determinare lo status di salute presentano alcune limitazioni: per lo scopo del progetto, misure generiche basate esclusivamente sul miglioramento clinico rispetto alla tecnologia standard potrebbero essere troppo semplicistiche e riduttive, non potrebbero catturare tutti gli effetti dell’intervento. Aspetti legati alla tecnologia o all’organizzazione potrebbero non essere presi in considerazione. Ecco perché un MCDA è un metodo che facilita l’identificazione della migliore possibile soluzione. Uno pseudo metodo di Best-Worst scaling è stato usato per gli obiettivi del progetto. Pertanto, la soluzione target è stata identificata nella proposta di Hologic, con la sua tecnologia Horizon Ci. Oltre agli aspetti tecnici, le competenze necessarie per realizzare questo progetto dal punto di vista gestionale, operativo ed economico non erano mai state acquisite prima nella mia esperienza professionale. Essere l'Owner di un progetto significa avere la responsabilità di guidare l'intero flusso di lavoro verso una gestione efficace, efficiente e di valore: la descrizione delle caratteristiche cliniche e tecniche, da presentare poi al pubblico clinico, è stata solo una delle responsabilità per una soddisfazione globale. È stata infatti necessaria una precisa programmazione temporale di tutte le attività per poter poi combinare tutti gli attori che hanno preso parte a questo processo: la comunicazione preventiva con le figure interne ed esterne al CMS ha permesso di realizzare il progetto senza molti intoppi, che potevano verificarsi in caso di una non corretta gestione delle attività preoperatorie da preparare. Dopo l'accettazione dell'offerta economica, è stato richiesto un calendario per le giornate di installazione, configurazione e formazione del personale tecnico in loco. In questa parte finale, è stato attualizzato tutto il piano operativo precedentemente programmato. Il programma prevedeva l'installazione in loco della nuova tecnologia sanitaria, la calibrazione del BMD e del TBS, la configurazione della macchina e il collaudo. Inoltre, durante i giorni di installazione è stata aperta un'agenda giornaliera per consentire la formazione del personale tecnico. Infine, è stato programmato un webinar con specialisti CMS nel campo della radiologia e dell'endocrinologia, con l'obiettivo di informarli sul corretto utilizzo delle soglie BMD, TBS e BSI secondo le linee guida ufficiali, al fine di interpretare in modo standardizzato qualsiasi caso clinico reale in esame.
Dual energy x-ray absorptiometry : a mini health technology assessment for innovation in technology within Santagostino Medical Centre
Laporta, Piertobia
2021/2022
Abstract
This thesis project is the main part of my personal contribution given during the internship carried out in the Department of Clinical Engineering at Santagostino medical centre, started in February 2022 and currently ongoing. The thesis work represents a final milestone for my Master of Science degree in Biomedical Engineering (Clinical Engineering track) at Politecnico di Milano. Centro Medico Santagostino was founded in 2009 with the objective to cover the growing needs of a large catchment area of patients: high quality medical services combined with the possibility to have an easy access to the available services thanks to fair prices. To date CMS counts 32 centres, the highest majority of them located in Milan and its hinterland: in the meanwhile, an increasing interest is pushing toward new openings located in Rome and Bologna. The pillars for value generation in Santagostino are represented by a weighted sum that accounts for innovation, short-time accessibility, transparency based on real data and, last but not least, the care toward the final user of any medical service here in Santagostino: the CMS clinics offer the possibility of performing medical examination over 73 different branches. For the purpose of this project, it has been carried out a Health Technology Assessment for the evaluation of the clinical effectiveness of an innovative Dual Energy X-ray Absorptometer, considered as a standard typology of examination for the diagnosis of osteoporosis and other endocrinologic diseases. Finally, a Multi Criteria Decision Analysis has been performed in order to attribute a score to the technologies that were under the assessment. With the choice of the new machine, a subsequent on-site installation and technology configuration in “Panfilo Castaldi” centre was taken out. Of course, with the objective to permit an optimization of wasting time and associated costs related to the company, it was scheduled an operating plan before the installation of the new DEXA technology. Moreover, a training of the technical and medical personnel was carried out to ensure a correct workflow for the exam execution, and consequently a production of a valuable report. Physicians, also, were trained with the aim to provide guidelines on the correct use of threshold values for the discrimination among different physio pathological conditions. Osteoporosis is an emerging medical and socioeconomic threat characterised by a systemic impairment of bone mass, strength, and microarchitecture, which increases the propensity of fragility fractures. It affects more than 75 million people in Europe, Japan and the USA, and causes more than 2.3 million fractures annually in Europe and the USA alone. Osteoporosis does not only cause fractures, it also causes people to become bedridden with secondary complications that may be life threatening in the elderly. Assessment of bone mass, mostly termed as Bone Mineral Density (BMD) is the standard method for the definition of a diagnostic approach for an osteoporotic fracture risk evaluation. An expert panel of the World Health Organization (WHO) recommended thresholds to divide among different categories of patient at risk of osteoporosis and proposed the DXA examination at the hip as the standard technology for the evaluation of an osteoporotic condition. Specialists in endocrinology, supported by the clinical opinion of the CMS health director, have presented, as a project for the new clinical offering for 2022, the intention to introduce newer technologies in the field of densitometry. The clinical requirement to be satisfied were concerned about the introduction of innovative software for the execution of textural measurements, in order to acquire information not only about bone quantity, but also regarding bone quality microarchitecture and applied loads. For these reasons, software integration was considered as a target tool to be adopted in this innovation. Textural parameters such as BMD and TBS provide useful information about bone quantity and bone quality, respectively, but detailed information about geometry and load definition are still missing. Recently, it has been developed a bone FEM analysis on DXA images named Bone Strain Index (BSI), in order to take into account bone strength features in the prediction of a fracture risk. Bone Strain Index automatically calculates strains and stresses in a bone segment, starting from a specific loading condition, defined specifically for each patient. It is based on finite element algorithms usually used in engineering applications. A Mini HTA was carried out in order to perform an assessment of the consequences after the introduction of the new technology from different points of view: being a complete private reality that is experiencing a swift growth, it was necessary to undertake a short timeframe and a limited resources analysis. In particular technical (TEC), clinical effectiveness (EFF), organizational (ORG) and economic domains (ECO) were analyzed to order to produce indications for the final decision-making process. The use of DALYs or QALYs as outcomes within cost-utility analyses to determine the health status presents some limitations: for the aims of this project, generic summary measures on only the clinical improvement with respect to a standard technology may be overly simplistic and reductionist and may not be capturing all of the benefits of this intervention, since other aspects related to TEC and ORG domains should be taken into account. That’s why multi-criteria decision analysis (MCDA) method aimed to facilitate the identification of the best possible solution. A pseudo Best-Worst Scaling method was used for our purposes. Therefore, the target solution was in this way identified as the Hologic proposal, with its Horizon Ci technology. Apart from the technical aspects, the skills that were needed to actualize this project from the managerial, operative and economic point of view were never acquired before in my professional experience. Being the owner of a project means to have the responsibility to guide the entire workflow towards an effective, efficient and valuable management: the description of the clinical and technical features, to be presented then to the clinical audience, has been only one of the responsibilities for a global satisfaction. In fact, a precise time-based schedule of all the activities was necessary in order then to combine all the actors take took part in this process: the preventive communication with internal and external figures of CMS allowed to actualize the project without many bottlenecks, prone to happen in case of an incorrect management of the preoperative activities to be prepared. After the acceptance of the economic offer, it was requested a schedule for the on-site installation, configuration and training of the Technical personnel days. In this final part, it was actualized all the operative plan previously scheduled. Program included the On-site installation of the new health technology, BMD and TBS calibration, configuration of the machine and testing. Also, a daily agenda was opened during the installation days for allowing technical personnel training. Finally, it was scheduled a webinar with CMS specialists in the field of radiology and endocrinology, with the aim to inform them about the correct use of BMD, TBS and BSI threshold according to official guidelines, in order to interpret in a standardized manner any real case study under examination.File | Dimensione | Formato | |
---|---|---|---|
Thesis_PiertobiaLaporta.pdf
accessibile in internet per tutti
Descrizione: Elaborato Tesi
Dimensione
4.25 MB
Formato
Adobe PDF
|
4.25 MB | Adobe PDF | Visualizza/Apri |
ExecutiveSummary_PiertobiaLaporta.pdf
accessibile in internet per tutti
Descrizione: Executive Summary
Dimensione
889.99 kB
Formato
Adobe PDF
|
889.99 kB | Adobe PDF | Visualizza/Apri |
I documenti in POLITesi sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
https://hdl.handle.net/10589/196561