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The integration of Clinical Decision Support Systems (CDSS) based on artificial intelligence (AI) in healthcare is groundbreaking evolution with enormous potential, but its development and ethical implementation, presents unique challenges, particularly in critical care, where physicians often deal with life-threating conditions requiring rapid actions and patients unable to participate in the decisional process. Moreover, development of AI-based CDSS is complex and should address different sources of bias, including data acquisition, health disparities, domain shifts during clinical use, and cognitive biases in decision-making. In this scenario algor-ethics is mandatory and emphasizes the integration of 'Human-in-the-Loop' and 'Algorithmic Stewardship' principles, and the benefits of advanced data engineering. The establishment of Clinical AI Departments (CAID) is necessary to lead AI innovation in healthcare, ensuring ethical integrity and human-centered development in this rapidly evolving field.
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Algoritmos , Inteligência Artificial , Cuidados Críticos , Sistemas de Apoio a Decisões Clínicas , Humanos , Inteligência Artificial/ética , Cuidados Críticos/ética , Sistemas de Apoio a Decisões Clínicas/ética , Tomada de Decisão Clínica/éticaRESUMO
BACKGROUND: On the basis of substantial evidence demonstrate that palliative care combined with standard care improves patient, caregiver, and society outcomes, we have developed a new healthcare model called radiotherapy and palliative care (RaP) outpatient clinic were a radiation oncologist and a palliative care physician make a joint evaluation of advanced cancer patients. METHODS: We performed a monocentric observational cohort study on advanced cancer patients referred for evaluation at the RaP outpatient clinic. Measures of quality of care were carried out. RESULTS: Between April 2016 and April 2018, 287 joint evaluations were performed and 260 patients were evaluated. The primary tumor was lung in 31.9% of cases. One hundred fifty (52.3%) evaluations resulted in an indication for palliative radiotherapy treatment. In 57.6% of cases was used a single dose fraction of radiotherapy (8 Gy). All the irradiated cohort completed the palliative radiotherapy treatment. An 8% of irradiated patients received the palliative radiotherapy treatment in the last 30 days of life. A total of 80% of RaP patients received palliative care assistance until the end of life. CONCLUSION: At the first descriptive analysis, the radiotherapy and palliative care model seem to respond to the need of multidisciplinary approach in order to obtain an improvement on quality of care for advanced cancer patients.
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Neoplasias , Radioterapia (Especialidade) , Humanos , Cuidados Paliativos/métodos , Neoplasias/patologia , Instituições de Assistência Ambulatorial , Atenção à SaúdeRESUMO
INTRODUCTION: During the first wave of the COVID-19 pandemic in spring 2020, our stroke network shifted from a drip-and-ship strategy (transport of acute ischemic stroke patients to the nearest primary stroke centers) toward a mothership model (direct transportation to the Comprehensive Stroke Center). We retrospectively analyzed stroke network performances comparing the two models. PATIENTS AND METHODS: All spoke-district patients treated with endovascular thrombectomy (EVT) between 15th March-15th June 2019 (drip-and-ship) and 2020 (mothership) were considered. We compared onset-to-groin time (OGT) and onset-to-needle time (ONT) between the two periods. Secondarily, we investigated other performances parameters (percentage of IV thrombolysis, timing of diagnostic and treatment) and clinical outcome (3-month modified Rankin Scale). RESULTS: Twenty-four spoke-district patients in 2019 (drip-and-ship) and 26 in 2020 (mothership) underwent EVT. The groups did not differ for age, sex, risk factors, pre-stroke mRS 0-1, NIHSS, and ASPECTS distribution. The MS model showed a significant decrease of the OGT (162.5 min vs 269 min, p = 0.001) without significantly affecting the ONT (140.5 min vs 136 min, p = 0.853), ensuring a higher number of IV thrombolysis in combination with EVT (p = 0.030). The mothership model showed longer call-to-door time (median + 23 min, p < 0.005), but shorter door-to-needle (median - 31 min, p = 0.001), and door-to-groin time (- 82.5 min, p < 0.001). We found no effects of the stroke network model on the 3-month mRS (ordinal shift analysis, p = 0.753). CONCLUSIONS: The shift to the mothership model during the COVID-19 pandemic guaranteed quicker EVT without significantly delaying IVT.
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Isquemia Encefálica , COVID-19 , Procedimentos Endovasculares , AVC Isquêmico , Acidente Vascular Cerebral , Humanos , Isquemia Encefálica/terapia , Terapia Trombolítica/efeitos adversos , Estudos Retrospectivos , AVC Isquêmico/epidemiologia , AVC Isquêmico/cirurgia , Pandemias , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/cirurgia , Trombectomia/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Resultado do TratamentoRESUMO
PURPOSE: Surgery is the main treatment for non-metastatic colorectal cancer. Despite huge improvements in perioperative care, colorectal surgery is still associated with a significant burden of postoperative complications and ultimately costs for healthcare organizations. Systematic clinical auditing activity has already proven to be effective in measuring and improving clinical outcomes, and for this reason, we decided to evaluate its impact in a large area of northern Italy. METHODS: The Emilia-Romagna Surgical Colorectal Audit (ESCA) is an observational, multicentric, retro-prospective study, carried out by 7 hospitals located in the Emilia-Romagna region. All consecutive patients undergoing surgery for colorectal cancer during a 54-month study period will be enrolled. Data regarding baseline conditions, preoperative diagnostic work-up, surgery and postoperative course will be collected in a dedicated case report form. Primary outcomes regard postoperative complications and mortality. Secondary outcomes include each center's adherence to the auditing (enrolment rate) and evaluation of the systematic feedback activity on key performance indicators for the entire perioperative process. CONCLUSION: This protocol describes the methodology of the Emilia-Romagna Surgical Colorectal Audit. The study will provide real-world clinical data essential for benchmarking and feedback activity, to positively impact outcomes and ultimately to improve the entire healthcare process of patients undergoing colorectal cancer surgery. CLINICAL TRIAL REGISTRATION: The study ESCA is registered on the clinicaltrials.gov platform (Identifier: NCT03982641).
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Neoplasias Colorretais , Cirurgia Colorretal , Neoplasias Colorretais/complicações , Neoplasias Colorretais/cirurgia , Atenção à Saúde , Humanos , Complicações Pós-Operatórias/etiologia , Estudos ProspectivosRESUMO
PURPOSE: The COVID-19 pandemic had an impact on health care, with disruption to routine clinical care. Our aim was to describe changes in prescription drugs dispensing in the primary and outpatient sectors during the first year of the pandemic across Europe. METHODS: We used routine administrative data on dispensed medicines in eight European countries (five whole countries, three represented by one region each) from January 2017 to March 2021 to compare the first year of the COVID-19 pandemic with the preceding 3 years. RESULTS: In the 10 therapeutic subgroups with the highest dispensed volumes across all countries/regions the relative changes between the COVID-19 period and the year before were mostly of a magnitude similar to changes between previous periods. However, for drugs for obstructive airway diseases the changes in the COVID-19 period were stronger in several countries/regions. In all countries/regions a decrease in dispensed DDDs of antibiotics for systemic use (from -39.4% in Romagna to -14.2% in Scotland) and nasal preparations (from -34.4% in Lithuania to -5.7% in Sweden) was observed. We observed a stockpiling effect in the total market in March 2020 in six countries/regions. In Czechia the observed increase was not significant and in Slovenia volumes increased only after the end of the first lockdown. We found an increase in average therapeutic quantity per pack dispensed, which, however, exceeded 5% only in Slovenia, Germany, and Czechia. CONCLUSIONS: The findings from this first European cross-national comparison show a substantial decrease in dispensed volumes of antibiotics for systemic use in all countries/regions. The results also indicate that the provision of medicines for common chronic conditions was mostly resilient to challenges faced during the pandemic. However, there were notable differences between the countries/regions for some therapeutic areas.
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COVID-19 , Antibacterianos , COVID-19/epidemiologia , Controle de Doenças Transmissíveis , Prescrições de Medicamentos , Humanos , Pandemias , Padrões de Prática MédicaRESUMO
INTRODUCTION: Bone metastases (BM) are still the main cause of morbidity and mortality in cancer patients, not only because of their complications, defined as skeletal-related events (SREs), but also because of the negative impact bone pain has on quality of life (QoL) and survival, especially when opioid analgesics and locoregional treatments fail. MATERIALS AND METHODS: A single-center prospective study was carried out on 12 patients with symptomatic BM treated with MRI-guided focused ultrasound (MR-HIFU). The primary endpoint was the effectiveness of MR-HIFU in reducing current and breakthrough cancer pain (BTCP) scores. The main secondary aims were the evaluation of circulating markers at different time-points and their relation to pain and procedure efficacy. Other secondary objectives included temporal evolution of pain response, evaluation of QoL, and side effects of the treatment. Descriptive statistics were used to evaluate primary and secondary endpoints. Questionnaires on pain and QoL completed at baseline and at 30 days were compared using appropriate statistical tests with exploratory intent. RESULTS: MR-HIFU was successfully completed in all 12 patients enrolled between September 2015 and December 2018. On day 30, 6 (50.0%) patients showed a complete response of current pain and 6 a partial response, while 5 (41.7%) obtained a complete BTCP response. A partial response of BM evaluated by MD Anderson criteria was obtained in 9 (81.8%) patients. Only one patient progressed in the target lesion after MR-HIFU. No treatment-related adverse events were recorded. Bone turnover markers CTX/RANK-L (P) do not demonstrate any significant change with the pain or BM response. CONCLUSION: In our patients, targeted therapy of painful BM with MRI-guided focused ultrasound ablation was safe and showed encouraging early-onset and functional results.
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Neoplasias Ósseas , Qualidade de Vida , Neoplasias Ósseas/secundário , Humanos , Imageamento por Ressonância Magnética , Espectroscopia de Ressonância Magnética , Dor/complicações , Estudos ProspectivosRESUMO
Donation after circulatory death (DCD) programs are expanding in Europe, in the attempt to expand donors pool. Even in controlled DCD donors, however, a protracted warm ischemia time occurring in the perimortem period might damage organs, making these unsuitable for transplantation. Implementing a strategy of extracorporeal interval support for organ retrieval (EISOR), a regional reperfusion with normothermic, oxygenated blood provides a physiologic environment allowing extensive assessment of potential grafts, and potentially promotes recovery of native function. Here we report the results of a multi-center retrospective cohort study including 29 Maastricht Category III controlled DCD donors undergoing extracorporeal support in a regional DCD/EISOR Training Center, and in the network of referring In-Training Centers, under the liaison of the regional Transplant Coordination Center during COVID-19 pandemic, between March 2020 and November 2021. The study aims to understand whether a mobile, experienced EISOR team implementing a consistent technique and sharing its equipe, expertise and equipment in a regional network of hospitals, might be effective and efficient in implementing the regional DCD program activity even in a highly stressed healthcare system.
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PURPOSE: In March 2014, we reported the activity and safety of 177Lu-DOTA-octreotate peptide receptor radionuclide therapy (Lu-PRRT) at two different dosages (18.5 GBq and 27.5 GBq in 5 cycles) in patients with progressive metastatic gastrointestinal neuroendocrine tumors (GI-NETs). Disease control rate (DCR) and toxicity were addressed. Herein, we report the late toxicity, progression-free survival (PFS), and overall survival (OS) in the same cohort after a 10-year follow-up. METHODS: We conducted an open-label, disease-oriented prospective phase II trial. From March 2008 to June 2011, 43 patients received 3.7 GBq or 5.5 GBq of Lu-PRRT every 6 to 8 weeks, each cycle repeated 5 times. All patients showed 68Gallium-DOTA-peptide PET/Octreoscan® positivity (score 3-4 Rotterdam scale) in known lesions. Tumor burden was estimated radiologically. Time-to-event data (PFS and OS) were described using Kaplan-Meier curves and compared with the log-rank test. RESULTS: Forty-three patients (28 males and 15 females) were evaluable and were monitored for a median period of 118 months (range 12.6-139.6). Median PFS in patients receiving 18.5 GBq was 59.8 months (95% confidence interval [95% CI] 14.3-79.6), identical to that of patients treated with 27.5 GBq (59.8 months, 95% CI 23.4-82.0). Median OS was 71.0 months (95% CI 46.1-107.3) in the group who received 18.5 GBq and 97.6 months (95% CI 64.3-not reached) in the group treated with 27.5 GBq (P = 0.22). Patients with progression limited to lymph nodes showed significantly longer median PFS and OS than those with hepatic lesions (P = 0.02 for PFS and P = 0.04 for OS). Age over 65 years at the time of PRRT was also significant for OS. Of note, no late hematological or renal toxicity was observed in either group. CONCLUSIONS: The long-term follow-up of the IRST phase II study shows that Lu-PRRT is a safe and effective therapy for patients with advanced GI-NET, the most important prognostic factor being tumor burden, hepatic lesions, and age. We believe that Lu-PRRT should be offered to patients with early-stage disease.
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Neoplasias Gastrointestinais , Tumores Neuroendócrinos , Idoso , Feminino , Seguimentos , Neoplasias Gastrointestinais/radioterapia , Humanos , Masculino , Tumores Neuroendócrinos/radioterapia , Octreotida/efeitos adversos , Estudos Prospectivos , Compostos Radiofarmacêuticos/efeitos adversosRESUMO
PURPOSE: Cost evaluation is becoming mandatory to support healthcare sustainability and optimize the decision-making process. This topic is a challenge, especially for complex and rapidly evolving treatment modalities such as radiotherapy (RT). The aim of the present study was to investigate the cost of RT in the last month of life of patients in an Italian cancer center. METHODS: This was a retrospective study on a cancer population (N= 160) who underwent RT or only an RT planning simulation in an end of life (EOL) setting. The cost of RT procedures performed on patients was collected according to treatment status, care setting, and RT technique used. Costs were valued according to the sum of reimbursements relating to all procedures performed and assessed from the perspective of the National Health System. RESULTS: The total cost of RT in the last month of life was 244,774, with an average cost per patient of 1530. Around 7.7% and 30.3% of the total cost was associated with patients who never started RT or who discontinued RT, respectively, while the remaining 62.0% referred to patients who completed treatment. Costs associated with outpatient and inpatient settings represented 54.3% and 38.6% of the total cost, respectively. The higher average cost per patient for the never-started and discontinued groups was correlated with patients who had a poor ECOG Performance Status. CONCLUSION: Improved prognostic accuracy and a better integration between radiotherapy and palliative care units could be a key to a better use of resources and to a reduction in the cost of EOL RT.
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Atenção à Saúde/organização & administração , Neoplasias/radioterapia , Radioterapia/economia , Assistência Terminal/economia , Assistência Terminal/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos RetrospectivosRESUMO
BACKGROUND: Accurate medication reconciliation reduces the risk of drug incompatibilities and adverse events that can occur during transitions in care. Community pharmacies (CPs) are a crucial part of the health care system and could be involved in collecting essential information on conventional and supplementary drugs used at home. OBJECTIVE: The aim of this paper was to establish an alliance between our cancer institute, Istituto Romagnolo per lo Studio dei Tumori (IRST), and CPs, the latter entrusted with the completion of a pharmacological recognition survey. We also aimed to integrate the national information technology (IT) platform of CPs with the electronic medical records of IRST. METHODS: Cancer patients undergoing antiblastic treatments were invited to select a CP taking part in the study and to complete the pharmacological recognition step. The information collected by the pharmacist was sent to the electronic medical records of IRST through the new IT platform, after which the oncologist performed the reconciliation process. RESULTS: A total of 66 CPs completed surveys for 134 patients. An average of 5.9 drugs per patient was used at home, with 12 or more used in the most advanced age groups. Moreover, 60% (80/134) of the patients used nonconventional products or critical foods. Some potential interactions between nonconventional medications and cancer treatments were reported. CONCLUSIONS: In the PROF-1 (Progetto di Rete in Oncologia con le Farmacie di comunità della Romagna) study, an alliance was created between our cancer center and CPs to improve medication reconciliation, and a new integrated IT platform was validated. TRIAL REGISTRATION: ClinicalTrials.gov NCT04796142; https://clinicaltrials.gov/ct2/show/NCT04796142.
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Reconciliação de Medicamentos , Farmacêuticos , Registros Eletrônicos de Saúde , Humanos , Estudos ProspectivosRESUMO
Cytarabine, the 4-amino-1-(ß-D-arabinofuranosyl)-2(1H)-pyrimidinone, (ARA-C) is an antimetabolite cytidine analogue used worldwide as key drug in the management of leukaemia. As specified in the manufacturers' instructions, once the components-sterile water and cytarabine powder-are unpackaged and mixed, the solution begins to degrade after 6 hours at room temperature and 12 hours at 4°C. To evaluate how to avoid wasting the drug in short-term, low-dose treatment regimens, the reconstituted samples, stored at 25°C and 4°C, were analyzed every day of the test week by reversed-phase HPLC and high-field NMR spectroscopy. All the samples remained unchanged for the entire week, which corresponds to the time required to administer the entire commercial drug package during low-dose therapeutic regimens. The drug solution was stored in a glass container at 4°C in an ordinary freezer and drawn with sterile plastic syringes; during this period, no bacterial or fungal contamination was observed. Our findings show that an cytarabine solution prepared and stored in the original vials retains its efficacy and safety and can, therefore, be divided into small doses to be administered over more days, thus avoiding unnecessary expensive and harmful waste of the drug preparation. Moreover, patients who require daily administration of the drug could undergo the infusion at home without need to go to hospital. The stability of the aliquots would help decrease hospitalization costs.
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Citarabina/química , Antimetabólitos Antineoplásicos/administração & dosagem , Antimetabólitos Antineoplásicos/química , Antimetabólitos Antineoplásicos/economia , Cromatografia Líquida de Alta Pressão , Redução de Custos , Citarabina/administração & dosagem , Citarabina/economia , Custos de Medicamentos , Estabilidade de Medicamentos , Armazenamento de Medicamentos , Humanos , Leucemia Mieloide Aguda/tratamento farmacológico , Adesão à Medicação , Ressonância Magnética Nuclear Biomolecular/métodos , Leucemia-Linfoma Linfoblástico de Células Precursoras/tratamento farmacológico , Soluções/químicaRESUMO
BACKGROUND: Healthcare providers across Europe are facing an ever-growing demand in clinical PET referrals. Currently, it is estimated that the administration of the PET tracer accounts for approximately 40% of the unitary PET procedure reimbursement (uPETr). Although the cost of PET/CT is highly dependent on the radiopharmaceutical cost itself, little is known about the economic impact of the utilized administration method and the repercussions on staff radiation exposure. Our objective was to evaluate the cost-effectiveness of automatic injection/fractionation system Intego™ (Bayer HealthCare, MEDRAD Europe, Netherlands) for istaff radiation exposure reduction and to validate its use with 18F-choline (FCH). METHODS: In order to validate Intego™ use with FCH we analyzed sterility, radioactivity fractionation accuracy and radiation protection for staff. We analyzed Intego™ impact on examination costs and its impact on organization efficiency. A cost-effectiveness analysis (CEA) was estimated as the incremental cost to reduce staff radiationexposure. RESULTS: According to our data, Intego™ ensures both sterility and accuracy of FCH doses' activity, reducing, at the same time, the exposure to radiation either whole body and at the extremities (94% and 75% respectively for the technicians and complete reduction for physicians). Intego™'s variable unit costs are higher than the SA (respectively 1.8% and 0.4% of PET reimbursement), while staff costs are significantly higher with SA (respectively 0.27% and 1.57% of unitary PET reimbursement [uPETr]). In our simulation, based on a 2,450 PET yearly output, the differential costs were slightly higher by using Intego™™ (+ 14%). The incremental cost-effectiveness ratio (ICER) was equal to 1.1, i.e. the healthcare provider pays an additional cost of 0.38% of uPETr to obtain a significant reduction of staff radiation exposure (-4.5 µS). CONCLUSIONS: Intego™, for its favorable results in terms of cost effectiveness, could be a useful tool in a nuclear medicine department, limiting the staff radiation exposure.
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Análise Custo-Benefício , Tomografia por Emissão de Pósitrons/efeitos adversos , Tomografia por Emissão de Pósitrons/economia , Colina/administração & dosagem , Colina/análogos & derivados , Injeções , Exposição à Radiação/prevenção & controle , RadiometriaRESUMO
BACKGROUND: Literature data on the overuse and misuse of diagnostic procedures leading to end-of-life aggressiveness are scarce due to the limited amount of estimated economic waste. This study investigated the potential overuse of diagnostic procedures in a population of end-of-life patients. METHODS: This is a retrospective study on consecutive advanced patients admitted into two Italian hospices. Frequency and relative costs of X-ray imaging, CT scans, MRI, and interventional procedures prescribed in the 3 months before admission were collected in patient electronic charts and/or in administrative databases. We conducted a deeper analysis of 83 cancer patients with a diagnosis of at least 1 year before admission to compare the number of examinations performed at two distant time periods. RESULTS: Out of 541 patients, 463 (85.6%) had at least one radiological exam in the 3 months before last admission. The mean radiological exam number was 3.9 ± 3.2 with a relative mean cost of 278.60 ± 270.20 per patient with a statistically significant (p < 0.001) rise near death. In the 86-patient group, a higher number of procedures was performed in the last 3 months of life than in the first quarter of the year preceding last admission (38.43 ± 28.62 vs. 27.95 ± 23.21, p < 0.001) with a consequent increase in cost. CONCLUSIONS: Patients nearing death are subjected to a high level of "diagnostic aggressiveness." Further studies on the integration of palliative care into the healthcare pathway could impact the appropriateness of interventions, quality of care, and, ultimately, estimated costs.
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Neoplasias/economia , Assistência Terminal/economia , Adulto , Idoso , Idoso de 80 Anos ou mais , Atenção à Saúde , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Assistência Terminal/métodosRESUMO
Increasing efforts are ongoing to deliver effective cancer care through integrated networks of services. Measuring patients' experience of care is essential to identify problematic areas that require organisational adjustments. The aim of the present study was to examine the validity of OPTION questionnaire, designed to measure patient's perceived continuity of care across different phases of their care pathway. The study was carried at the Institute for Cancer Treatment and Research, Meldola and the oncology departments of the Local Health Authority of Romagna, Italy. Principal component analysis (PCA) was performed to identify factors underlying patients' perception of continuity of care. Factor scores were compared between patients with or without a care coordinator using Mann-Whitney test. The study sample consisted of 214 patients with breast or colorectal cancer, with a mean age of 62.3 years. Most patients identified the oncologist as their care coordinator. Five factors were extracted using PCA: (1) "trustful relationship with health care staff," (2) "information on care pathway," (3) "information on changes related to the illness," (4) "feelings of abandonment" and (5) "collaboration among health care professionals." The scores of factors 2 and 3 were significantly higher among those with a care coordinator. The OPTION questionnaire is a reliable instrument that can help clinicians and administrative stakeholder target efforts and resources in the pursuit of quality of care.
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Neoplasias da Mama/terapia , Neoplasias Colorretais/terapia , Continuidade da Assistência ao Paciente , Comportamento Cooperativo , Relações Médico-Paciente , Confiança , Idoso , Procedimentos Clínicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Análise de Componente Principal , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Appropriate cessation of chemotherapy and timely referral of patients to hospice services are crucial for the quality of care near death. We investigated the quality of care in our Cancer Institute in very advanced metastatic colorectal cancer patients treated in real life. PATIENTS AND METHODS: We performed a retrospective analysis of electronic medical data of patients with metastatic colorectal cancer who were candidates for chemotherapy during the study period (1 January 2007-30 June 2014) and died before 31 December 2014. Quality-of-cancer-care indicators were calculated for the overuse of chemotherapy and referral to hospice. Predictive factors of chemotherapy discontinuation and hospice referral in end-of life care were investigated using parametric and nonparametric methods. RESULTS: Of the 365 patients who died before 31 December 2014, 26 (7.1%) received chemotherapy in the last 14 days of life and 36 (9.8%) started a new chemotherapy regimen in the last 30 days of life. Factors associated with the overuse of chemotherapy were being < 70 years of age for both indicators and not having received advanced chemotherapy treatments for the former indicator. The majority of patients (74.7%) had access to hospice services, of whom only a small percentage (7.2%) accessed them very near to death. CONCLUSIONS: According to the criteria used, our Institute provides a good quality of cancer care for dying colorectal cancer patients, measured by the use of chemotherapy and referral to hospice in their last days of life.
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Neoplasias Colorretais/terapia , Tratamento Farmacológico/psicologia , Tratamento Farmacológico/normas , Cuidados Paliativos/métodos , Academias e Institutos/organização & administração , Adulto , Idoso , Idoso de 80 Anos ou mais , Registros Eletrônicos de Saúde , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Estatísticas não Paramétricas , Suspensão de Tratamento/normasRESUMO
BACKGROUND: Surgery has become an important tool for cancer treatment, requiring many available resources and a good organization of the surgery service. The aim of this study was to provide robust data for policymakers on the impact of hospital volume on survival, taking into account different sources of information. METHODS: We performed a retrospective study in a cohort of patients with gastric cancer submitted to partial or total gastrectomy. Data for the analysis were retrieved from regional administrative databases, the regional death registry, and histological reports. The main outcome measures were operative mortality and long-term survival. The associations between hospital volume and risk of mortality were calculated using a Cox multiple regression analysis. RESULTS: The estimated relationship between operative mortality and volume was not statistically significant. Conversely, high-volume hospitals had an increased likelihood of long-term survival compared to low-volume institutions: hazard ratio 0.79 (95% confidence interval, 0.66-0.94, p = 0.01). The percentage variation between crude and adjusted HRs using only administrative data or administrative and histological data was very small. However, the combined use of administrative and clinical data provided a more accurate model for estimating risk-adjusted mortality. CONCLUSIONS: A positive association between hospital volume and survival was evident for long-term outcome after adjusting for patient and tumor confounding. Moreover, the patient's choice of hospital was not guided by specific care pathways or screening programs, and prognosis was not poorer for patients in high-volume hospitals. These findings suggest that there is leeway for improving access to surgery for gastric cancer patients.
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Hospitais/estatística & dados numéricos , Neoplasias Gástricas/mortalidade , Neoplasias Gástricas/cirurgia , Idoso , Estudos de Coortes , Feminino , Gastrectomia/estatística & dados numéricos , Mortalidade Hospitalar , Hospitais com Alto Volume de Atendimentos/estatística & dados numéricos , Hospitais com Baixo Volume de Atendimentos/estatística & dados numéricos , Humanos , Itália , Linfonodos/patologia , Linfonodos/cirurgia , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Neoplasias Gástricas/patologia , Taxa de Sobrevida , Resultado do TratamentoRESUMO
This study evaluated the economic burden of metastatic non-small cell lung cancer patients before and after the availability of an immuno-oncology (IO) regimen as a first-line (1L) treatment. Patients from 2014 to 2020 were categorized according to mutational status into mutation-positive and negative/unknown groups, which were further divided into pre-1L IO and post-1L IO sub-groups depending on the availability of pembrolizumab monotherapy in 1L. Healthcare costs and HCRU for a 1L treatment and overall follow-up were reported as the mean total and per-month cost per patient by groups. Of 644 patients, 125were mutation-positive and 519 negative/unknown (229 and 290 in pre- and post-1L IO, respectively). The mean total per-patient cost in 1L was lower in pre- (EUR 7804) and post-1L IO (EUR 19,301) than the mutation-positive group (EUR 45,247), persisting throughout overall disease follow-up. However, this difference was less when analyzing monthly costs. Therapy costs were the primary driver in 1L, while hospitalization costs rose during follow-up. In both mutation-positive and post-IO 1L groups, the 1L costs represented a significant portion (70.1% and 66.3%, respectively) of the total costs in the overall follow-up. Pembrolizumab introduction increased expenses but improved survival. Higher hospitalisation and emergency room occupation rates during follow-up reflected worsening clinical conditions of the negative/unknown group than the mutation-positive population.
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AIMS: To assess the effectiveness of the intermittent-scanned continuous glucose monitoring (isCGM) system in preventing severe hypoglycemic episodes and in improving glucose parameters and quality of life. METHODS: Four hundred T1D individuals were enrolled in a prospective real-word study with an intermittently scanned continuous glucose monitoring device during the 12-months follow-up. The primary endpoint was the incidence of severe hypoglycemic events. RESULTS: 82% of subjects were naïve to the use of the device (group A) and 18% were already wearing the system (group B). The cumulative incidence of severe hypoglycemia (SH) at 12 months was 12.06 per 100 person-year (95% CI: 8.35-16.85) in group A and 10.14 (95% CI: 4.08-20.90) in group B without inter-group differences. In group A there was a significant decrease in SH at 12 months compared to 3 months period (p = 0.005). Time in glucose range significantly increased in both groups accompanied with a significant decrease in glucose variability. HbA1c showed a progressive significant time-dependent decrease in group A. The use of the device significantly improved the perceived quality of life. CONCLUSION: This study confirmed the effectiveness of the isCGM in reducing hypoglycemic risk without glucose deterioration, with potential benefits on adverse outcomes in T1D individuals. TRIAL REGISTRATION: ClinicalTrials.gov registration no. NCT04060732.
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In recent decades, the approach to blood transfusion has changed radically around the world. In the past, transfusion represented the only solution for anemia, today the paradigm has changed: through the implementation of the Patient blood management (Pbm) program it is possible to manage the patient's own blood in order to reduce and, in many cases, eliminate the administration of blood components for transfusion. This approach increases patient safety by reducing clinical risks as well as costs. The implementation of the PBM program in Australia has demonstrated that the use of blood is not strictly necessary but, on the contrary, is largely avoidable. Through change management the traditional attitude of doctors and healthcare facilities can be modified. Law no. 24/2017 focuses on the safety of care by encouraging the necessary implementation of Pbm in hospital settings; the failure to adopt an organized Pbm program may constitute, in the event of an adverse transfusion event, a clear profile of health responsibility on the part of the management and clinicians.