Scoping Meta-Review of Methods Used to Assess Artificial Intelligence-Based Medical Devices for Heart Failure

Artificial intelligence and machine learning (AI/ML) are playing increasingly important roles, permeating the field of medical devices (MDs). This rapid progress has not yet been matched by the Health Technology Assessment (HTA) process, which still needs to define a common methodology for assessing AI/ML-based MDs. To collect existing evidence from the literature about the methods used to assess AI-based MDs, with a specific focus on those used for the management of heart failure (HF), the International Federation of Medical and Biological Engineering (IFMBE) conducted a scoping meta-review. This manuscript presents the results of this search, which covered the period from January 1974 to October 2022. After careful independent screening, 21 reviews, mainly conducted in North America and Europe, were retained and included. Among the findings were that deep learning is the most commonly utilised method and that electronic health records and registries are among the most prevalent sources of data for AI/ML algorithms. Out of the 21 included reviews, 19 focused on risk prediction and/or the early diagnosis of HF. Furthermore, 10 reviews provided evidence of the impact on the incidence/progression of HF, and 13 on the length of stay. From an HTA perspective, the main areas requiring improvement are the quality assessment of studies on AI/ML (included in 11 out of 21 reviews) and their data sources, as well as the definition of the criteria used to assess the selection of the most appropriate AI/ML algorithm. © 2023 by the authors

Analisi dell’evoluzione del mercato ospedaliero in Italia negli anni 2001-2005

L’assistenza ospedaliera, sia per acuti che per riabilitazione, rappresenta in Italia una quota rilevante dell’assistenza sanitaria e viene erogata da strutture che si differenziano per la loro natura economica, ma anche per la tipologia di assistenza erogata. Ferme restando tutte le peculiarità che la letteratura ha ampiamente dibattuto sulla natura del ‘mercato’ nel settore sanitario, si può ipotizzare che le caratteristiche dell’offerta e della domanda abbiano contribuito, in un certo senso, a rendere il funzionamento del settore sanitario simile a quello di molti settori industriali tradizionali. Questo lavoro intende analizzare l’evoluzione del ‘mercato’ dell’assistenza ospedaliera tra il 2001 e il 2005 sia a livello nazionale che nelle Regioni e nelle Province autonome. In questa prospettiva il lavoro supera il tradizionale dualismo tra ‘pubblico e privato’ proponendo una segmentazione del mercato che tiene conto della presenza rilevante del terzo settore e, in esso, della qualificata presenza delle istituzioni di ispirazione cristiana. I risultati mettono in evidenza alcuni trend che, seppur ancora deboli, possono identificare specifici percorsi di cambiamento nel sistema dell’offerta. I dati mostrano un arretramento della produzione diretta di servizi sanitari attraverso l’operatore pubblico e una crescita significativa dell’attività riferita ad operatori privati soprattutto con orientamento imprenditoriale

Disruptive technologies in health care disenchanted: A systematic review of concepts and examples

Objectives To clarify the concept of disruptive technologies in health care, provide examples and consider implications of potentially disruptive technologies for health technology assessment (HTA). Methods We conducted a systematic review of conceptual and empirical papers on healthcare technologies that are described as disruptive. We searched MEDLINE and Embase from 2013 to April 2019 (updated in December 2021). Data extraction was done in duplicate by pairs of reviewers utilizing a data extraction form. A qualitative data analysis was undertaken based on an analytic framework for analysis of the concept and examples. Key arguments and a number of potential predictors of disruptive technologies were derived and implications for HTA organizations were discussed. Results Of 4,107 records, 28 were included in the review. Most of the papers included conceptual discussions and business models for disruptive technologies; only few papers presented empirical evidence. The majority of the evidence is related to the US healthcare system. Key arguments for describing a technology as disruptive include improvement of outcomes for patients, improved access to health care, reduction of costs and better affordability, shift in responsibilities between providers, and change in the organization of health care. A number of possible predictors for disruption were identified to distinguish these from sustaining innovations. Conclusions Since truly disruptive technologies could radically change technology uptake and may modify provision of care patterns or treatment paths, they require a thorough evaluation of the consequences of using these technologies, including economic and organizational impact assessment and careful monitoring.Fil: Perleth, Matthias. Gemeinsamer Bundesausschuss; AlemaniaFil: Di Bidino, Rossella. Fondazione Policlinico Universitario Agostino Gemelli Irccs; ItaliaFil: Huang, Li Ying. Center For Drug Evaluation; ChinaFil: Jones, Lydia. Gemeinsamer Bundesausschuss; AlemaniaFil: Mujoomdar, Michelle. Canadian Agency For Drugs And Technologies In Health; CanadáFil: Myles, Susan. Health Technology Wales; Reino UnidoFil: Pichón-riviere, Andres. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Sabirin, Junainah. Ministry of Health Malaysi; MalasiaFil: Schuller, Tara. International Network of Agencies for Health Technology Assessment; CanadáFil: Washington, Jennifer. Health Technology Wales; Reino Unid

Costs of Bloodstream Infections Caused by Escherichia coli and Influence of Extended-Spectrum-β-Lactamase Production and Inadequate Initial Antibiotic Therapy▿

Escherichia coli is the leading cause of bloodstream infections (BSIs) caused by Gram-negative bacteria. The increasing prevalence of antibiotic-resistant E. coli strains, particularly those producing extended-spectrum β-lactamases (ESBLs), increases the odds that empirically prescribed antimicrobial therapy for these infections will be inadequate, but the economic impact of this risk has not been fully evaluated. In the present retrospective 1-year analysis of 134 consecutive E. coli BSIs in our hospital, we explored the clinical and economic impacts of (i) inadequate initial antimicrobial treatment (IIAT) (i.e., empirical treatment with drugs to which the isolate had displayed in vitro resistance) of these infections and (ii) ESBL production by the bloodstream isolate. Cost data were obtained from the hospital accounting system. Compared with the 107 (79.8%) adequately treated patients, the 27 (20.1%) who received IIAT had a higher proportion of ESBL BSIs (74.0% versus 15.8%), longer (+6 days) and more costly (+EUR 4,322.00) post-BSI-onset hospital stays, and higher 21-day mortality rates (40.7% versus 5.6%). Compared with the 97 non-ESBL infections, the 37 (27.6%) ESBL BSIs were also associated with longer (+7 days) and more costly (+EUR 5,026.00) post-BSI-onset hospital stays and increased 21-day mortality (29.7% versus 6.1%). These findings confirm that the hospital costs and mortality associated with E. coli BSIs are significantly increased by ESBL production and by IIAT

Incidence and predictive factors for complications after uterine leiomyoma embolization

Study question: What is the risk for complications after uterine leiomyoma embolisation and what are the factors associated with complications? Summary answer: The cumulative risk of complications after embolisation is relatively low even in the long term, but submucosal leiomyoma location may increase the risk. What is known already: A broad spectrum of complications after leiomyoma embolisation have been described with widely varying rates. There is uncertainty over the actual risk of complications and the factors associated with this risk. Study design, size, duration: This was a prospective cohort study of 288 consecutive women undergoing leiomyoma embolisation set in the general gynaecology clinic of a university teaching hospital between January 2001 and December 2010. Participants/materials, setting, methods: Complications occurring after embolisation were categorized as major or minor according to the severity of their impact on health, the level of care required and the outcome. Cumulative complication rates were estimated by survival analysis and log-rank tests according to baseline variables. Multivariable Cox proportional hazards analysis was performed to adjust for confounders. Main results and the role of chance: Forty-eight patients experienced a complication at a median of 5 months (95% CI,4.1-11.4) after embolisation. Complications were minor in 38 and major in 10 patients. The cumulative overall complication rate was 13% (95% CI,9.0-17.0) at 6 months, 16% (95% CI,11.0-20.0) at 1 year, 17% (95% CI,12.0-22.0) at 3 years, 18% (95% CI,12.9-22.8) at 5 years. The most frequent complication (19/48, 39.6 %) was leiomyoma expulsion, which occurred spontaneously in 13 (68.4%) cases and required assistance in 6 (31.6%) cases. Eight (2.8%) patients underwent re-intervention, including 6 hysteroscopic myomectomies, 1 laparoscopic myomectomy, and 1 hysteroscopic adhesiolysis, as a result of a complication. Submucosal leiomyoma location was the only baseline variable associated with an increased risk for complications (HR,2.28, 95% CI,1.24-4.18, p=0.008). Limitations, reasons for caution: Our population did not include black women, who have been reported to be at higher risk for postprocedural complications compared to white women. Thus, if black women were involved in the study, higher morbidity rates might have been observed. Wider implications of the findings: Women with submucosal leiomyomas at the time of embolisation are more likely to have postprocedural complications. This is important new information when counselling patients contemplating this therapeutic approach. Study funding/competing interest(s): The authors have no competing interests to declare. The study was not supported by any external grant

Road toward a new model of care for idiopathic pulmonary fibrosis in the Lazio Region

A timely, confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF) has a significant impact on the evolution of the disease. The current model of care in the Lazio region (in Italy) was assessed on the basis of real-world data provided by the four reference centers responsible for diagnosing and treating IPF. The 5-year, population-based, retrospective longitudinal study provided the data that is at the basis of the current proposal for a new clinical and therapeutic pathway (DTCP) and has been shared with regional decision makers. A DTCP must be defined and based on four pillars: GPs, pulmonologists, IPF centers, and telemedicine. Each must play a role within a sort of hub-and-spoke model. IPF centers remain the hubs, while spokes are identified in trained GPs and pulmonologists

Transvaginal ultrasonography and magnetic resonance imaging for assessment of presence, size and extent of invasive cervical cancer.

OBJECTIVES: To prospectively assess the diagnostic performance of transvaginal ultrasound and magnetic resonance imaging (MRI), using histology as the gold standard, with regard to the presence, size, and extent of invasive cervical cancers and the detection of metastatic lymph nodes. METHODS: This was a prospective study designed to examine patients with invasive cervical cancer by means of ultrasonography and MRI within 1 week before surgery. We included patients with early cervical cancer planned for primary surgery and patients with locally advanced cervical cancer planned for surgery after neoadjuvant treatment. RESULTS: An invasive cervical cancer tumor was confirmed in the 33 patients triaged for primary surgery. A residual tumor mass was documented in 27 out of 35 patients (77%) who underwent surgery after neoadjuvant treatment, with no residual tumor in eight (23%) cases. Transvaginal ultrasound and MRI examinations showed the presence of the tumor mass in 56/60 (93%) and in 53/60 (88%) cases, respectively. Ultrasound and MRI detected the depth of stromal invasion to be greater than two-thirds with a sensitivity of 100% (16/16) and 94% (15/16) (P = 1) and a false-positive rate of 25% (13/52) and 15% (8/52) (P = 0.58), respectively. Both ultrasound and MRI provided low sensitivities (3/5, 60% and 2/5, 40% respectively, P = 1) and the same false-positive rate (7/63, 11%) for the presence of parametrial infiltration. One of the 11 patients with metastatic lymph nodes was detected at ultrasound examination (sensitivity 9%) with no false-positive cases, while MRI correctly identified three positive cases (sensitivity 27%, 3/11) with two false-positive cases (false positive rate 4%, 2/55). CONCLUSIONS: Ultrasound and MRI had similar sensitivity and specificity with regard to the parameters investigated. Ultrasound has the advantages over MRI of low cost, widespread availability and of being a relatively quick procedure. Ultrasound should be considered as a suitable diagnostic method in the preoperative work-up of cervical cancer

The sonographic prediction of invasive carcinoma in unilocular-solid ovarian cysts in premenopausal patients: a pilot study.

BACKGROUNDUnilocular-solid ovarian cysts are a rare but challenging pathology in young women, with a desire to spare their fertility. In these cases, the risks of borderline and invasive disease are around 10 and 20%, respectively. No ultrasound rule has yet demonstrated the ability to discriminate with high accuracy, a borderline tumor from a benign tumor or 'invasive tumor'. The aim of this study was to assess the predictive performance of different ultrasound parameters in differentiating benign and borderline tumors versus invasive malignant tumors in premenopausal patients with unilocular-solid ovarian masses.METHODSWomen aged 6450 years with unilocular-solid adnexal masses with a maximum diameter 6410 cm, undergoing surgery in our department within 3 months from ultrasound examination, were included in this retrospective study. A standardized ultrasound examination technique and predefined definitions of ultrasound characteristics were used. The results of ultrasound examination using gray scale and color Doppler were compared with the histological examination of the respective surgical specimens.RESULTSThe study included 51 patients. On histological examination, 36 (70%) lesions were classified as benign, 10 (20%) as borderline ovarian tumors and 5 (10%) as invasively malignant tumors. In receiver-operating characteristic curve analysis, the best cut-off for the largest solid component with regard to discriminating non-invasive (benign or borderline) from invasive tumors was 14 mm. A largest solid component >14 mm, the presence of papillation blood flow and the combination of the two parameters provided a sensitivity of 100% and a specificity of 63, 63 and 80%, respectively.CONCLUSIONSTransvaginal ultrasound examination seems to be able to discriminate between invasive and non-invasive tumors in the premenopausal patients with unilocular-solid adnexal masses. Because of the retrospective nature of the study, further prospective clinical trials are needed to confirm the accuracy of the selected sonographic parameters in discriminating the invasive and non-invasive adnexal tumors