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Background: Cardiovascular diseases (CVDs) pose a significant global health challenge, necessitating innovative approaches for primary prevention. Personalized prevention, based on genetic risk scores (PRS) and digital technologies, holds promise in revolutionizing CVD preventive strategies. However, the clinical efficacy of these interventions requires further investigation. This study presents the protocol of the INNOPREV randomized controlled trial, aiming to evaluate the clinical efficacy of PRS and digital technologies in personalized cardiovascular disease prevention. Methods: The INNOPREV trial is a four-arm RCT conducted in Italy. A total of 1,020 participants, aged 40-69 with high 10-year CVD risk based on SCORE 2 charts, will be randomly assigned to traditional CVD risk assessment, genetic testing (CVD PRS), digital intervention (app and smart band), or a combination of genetic testing and digital intervention. The primary objective is to evaluate the efficacy of providing CVD PRS information, measured at baseline, either alone or in combination with the use of an app and a smart band, on two endpoints: changes in lifestyle patterns, and modification in CVD risk profiles. Participants will undergo a comprehensive assessment and cardiovascular evaluation at baseline, with follow-up visits at one, five, and 12 months. Lifestyle changes and CVD risk profiles will be assessed at different time points beyond the initial assessment, using the Life's Essential 8 and SCORE 2, respectively. Blood samples will be collected at baseline and at study completion to evaluate changes in lipid profiles. The analysis will employ adjusted mixed-effect models for repeated measures to assess significant differences in the data collected over time. Additionally, potential moderators and mediators will be examined to understand the underlying mechanisms of behavior change. Discussion: As the largest trial in this context, the INNOPREV trial will contribute to the advancement of personalized cardiovascular disease prevention, with the potential to positively impact public health and reduce the burden of CVDs on healthcare systems. By systematically examining the clinical efficacy of PRS and digital interventions, this trial aims to provide valuable evidence to guide future preventive strategies and enhance population health outcomes.
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Cardiovascular Diseases , Digital Technology , Humans , Cardiovascular Diseases/prevention & control , Middle Aged , Adult , Aged , Female , Male , Risk Assessment/methods , Italy , Precision Medicine , Genetic Testing , Primary Prevention , Genetic Risk ScoreABSTRACT
AIMS: To describe the health literacy (HL) levels of hospitalised patients and their relationship with nursing diagnoses (NDs), nursing interventions and nursing measures for clinical risks. DESIGN: Retrospective study. METHODS: The study was conducted from December 2020 to December 2021 in an Italian university hospital. From 146 wards, 1067 electronic nursing records were randomly selected. The Single-Item Literacy Screener was used to measure HL. Measures for clinical risks were systematically assessed by nurses using Conley Index score, the Blaylock Risk Assessment Screening Score, Braden score, and the Barthel Index. A univariable linear regression model was used to assess the associations of HL with NDs. RESULTS: Patients with low HL reported a higher number of NDs, interventions and higher clinical risks. HL can be considered a predictor of complexity of care. CONCLUSIONS: The inclusion of standardised terms in nursing records can describe the complexity of care and facilitate the predictive ability on hospital outcomes. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: HL evaluation during the first 24 h. From hospital admission could help to intercept patients at risk of higher complexity of care. These results can guide the development of interventions to minimise needs after discharge. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution was required to design or undertake this research. Patients contributed only to the data collection.
Subject(s)
Health Literacy , Humans , Retrospective Studies , Hospitalization , Patient Discharge , Hospitals, UniversityABSTRACT
OBJECTIVES: There is evidence that there are differences in survival outcomes among patients with endometrial cancer of different ethnic groups. We aimed to assess the quantity and quality of race/ethnicity reporting in the literature on endometrial cancer published from January 2020 to December 2020. METHODS: In this systematic review, electronic searches of PubMed, MEDLINE, Web of Sciences, Scopus, and Cochrane Library databases were performed for all articles published in 2020. A total of 3330 articles were reviewed, of which 949 (35%) peer-reviewed human-based articles focusing on endometrial cancer were included. Non-research-focused articles, review articles, meta-analyses, case reports, and non-human studies were excluded. We analyzed the proportion of studies reporting race/ethnicity and assessed the quality of reporting with regard to the adherence to the International Committee of Medical Journal Editors (ICMJE) recommendations. We evaluated the influence of study characteristics on race/ethnicity reporting and compared articles published in journals which adhere to the ICMJE recommendations against those that did not explicitly state that they did. RESULTS: Of the 949 (28.5%) included articles, 166 (17.5%) reported race/ethnicity of patients, with low quality of reporting. The reporting rate of race/ethnicity was similar when comparing articles from ICMJE and non-ICMJE journals (62 (20.4%) vs 104 (16.1%); p=0.11), prospective versus retrospective studies (53 (22.7%) vs 113 (15.8%); p=0.02), and national versus international studies (147 (17.5%) vs 19 (17.4%); p=0.99). Studies performed in the WHO region of Americas were significantly more consistent in reporting race compared with other regions (119 (44.7%) vs 23 (6.8%) European, 2 (7.4%) Eastern Mediterranean, 21 (7.1%) Western Pacific, 0 (0%) South-East Asia; p<0.001). Female corresponding authors were significantly more consistent in reporting race than male authors (94 (22.5%) vs 72 (13.6%); p<0.001). CONCLUSIONS: Human-based articles focusing on endometrial cancer have a low frequency and quality of race/ethnicity reporting, even in journals claiming to follow ICMJE recommendations.
Subject(s)
Endometrial Neoplasms , Ethnicity , Humans , Female , Male , Prospective Studies , Retrospective Studies , Databases, FactualABSTRACT
INTRODUCTION: Umbrella review is one of the terms used to describe an overview of systematic reviews. During the last years, a rapid increase in the number of umbrella reviews on epidemiological studies has been observed, but there is no systematic assessment of their methodological and reporting characteristics. Our study aims to fill this gap by performing a systematic mapping of umbrella reviews in epidemiological research. METHODS: We will perform a meta-epidemiological study including a systematic review in MEDLINE and EMBASE to identify all the umbrella reviews that focused on systematic reviews of epidemiological studies and were published from inception until December 31, 2022. We will consider eligible any research article which was designed as an umbrella review and summarized systematic reviews and meta-analyses of epidemiological studies. From each eligible article, we will extract information about the research topic, the methodological characteristics, and the reporting characteristics. We will examine whether the umbrella reviews assessed the strength of the available evidence and the rigor of the included systematic reviews. We will also examine whether these characteristics change across time. DISCUSSION: Our study will systematically appraise the methodological and reporting characteristics of published umbrella reviews in epidemiological literature. The findings of our study can be used to improve the design and conduct of future umbrella reviews, to derive a standardized set of reporting and methodological guidelines for umbrella reviews, and to allow further meta-epidemiological work. SYSTEMATIC REVIEW REGISTRATION: osf.io/sxzc6.
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Research Design , Humans , Epidemiologic Studies , Systematic Reviews as Topic , Review Literature as Topic , Meta-Analysis as TopicABSTRACT
This Viewpoint examines the increase in "mega-journals" (prolific publishers of medical articles) and both the opportunities and threats to scientific research they present.
Subject(s)
Periodicals as Topic , Publishing , Periodicals as Topic/standards , Publishing/standardsABSTRACT
The management of acute chest pain is one of the challenges for emergency departments (EDs) worldwide. This study aims to provide insights into clinical and organizational aspects related to the use of different cardiac troponin tests for the diagnosis of NSTEMI. A prospective observational study was conducted among 12 Italian EDs. Eligible participants had chest pain of suspected cardiac origin and accessed EDs from January 2017 to March 2019. A 30-day follow-up was performed to gather information about the main cardiac outcomes. Tests validity and performance were assessed by computing sensitivity, specificity, positive and negative predictive values and area under the ROC curve. The independent association between adverse event end point at 30 days and type of troponin was evaluated by multiple logistic regression models, using odds ratio and 95% confidence interval. 2913 patients were included. Almost 72% were affected by comorbidities and most of them stayed in the EDs for more than 3 h, with significant differences among the different troponin assays. The results of follow-up at 30 days for the outcomes considered for the patients who were ruled out in 3 h or less did not differ significantly compared to those ruled out after 3 h or more. After adjustment for confounders, patients admitted to an ED that used a high-sensitivity troponin were at a lower risk of having a MACE (OR = 0.53, 95%CI 0.35-0.90) and a non-significant lower risk of myocardial infarction (OR = 0.68, 95% CI 0.41-1.13, p = 0.1314) at 30 days compared to patients admitted to an ED that used a standard troponin. Appropriate troponin testing is extremely important for differential diagnosis and for addressing proper treatment and safe procedures for patients who are not admitted to the hospital.
Subject(s)
Myocardial Infarction , Non-ST Elevated Myocardial Infarction , Humans , Sensitivity and Specificity , Biomarkers , Myocardial Infarction/diagnosis , Emergency Service, Hospital , Troponin , Chest Pain/diagnosis , Chest Pain/etiologyABSTRACT
Background: Debate exists about whether extra protection of elderly and other vulnerable individuals is feasible in COVID-19. We aimed to assess the relative infection rates in the elderly vs the non-elderly and, secondarily, in children vs adults. Methods: We performed a systematic review and meta-analysis of seroprevalence studies conducted in the pre-vaccination era. We identified representative national studies without high risk of bias through SeroTracker and PubMed searches (last updated May 17, 2022). We noted seroprevalence estimates for children, non-elderly adults, and elderly adults, using cut-offs of 20 and 60 years (or as close to these ages, if they were unavailable) and compared them between different age groups. Results: We included 38 national seroprevalence studies from 36 different countries comprising 826 963 participants. Twenty-six of these studies also included pediatric populations and twenty-five were from high-income countries. The median ratio of seroprevalence in elderly vs non-elderly adults (or non-elderly in general, if pediatric and adult population data were not offered separately) was 0.90-0.95 in different analyses, with large variability across studies. In five studies (all in high-income countries), we observed significant protection of the elderly with a ratio of <0.40, with a median of 0.83 in high-income countries and 1.02 elsewhere. The median ratio of seroprevalence in children vs adults was 0.89 and only one study showed a significant ratio of <0.40. The main limitation of our study is the inaccuracies and biases in seroprevalence studies. Conclusions: Precision shielding of elderly community-dwelling populations before the availability of vaccines was indicated in some high-income countries, but most countries failed to achieve any substantial focused protection. Registration: Open Science Framework (available at: https://osf.io/xvupr).
Subject(s)
COVID-19 , Child , Humans , Adult , Middle Aged , COVID-19/epidemiology , Seroepidemiologic Studies , Bias , VaccinationABSTRACT
The largest burden of COVID-19 is carried by the elderly, and persons living in nursing homes are particularly vulnerable. However, 94% of the global population is younger than 70 years and 86% is younger than 60 years. The objective of this study was to accurately estimate the infection fatality rate (IFR) of COVID-19 among non-elderly people in the absence of vaccination or prior infection. In systematic searches in SeroTracker and PubMed (protocol: https://osf.io/xvupr), we identified 40 eligible national seroprevalence studies covering 38 countries with pre-vaccination seroprevalence data. For 29 countries (24 high-income, 5 others), publicly available age-stratified COVID-19 death data and age-stratified seroprevalence information were available and were included in the primary analysis. The IFRs had a median of 0.034% (interquartile range (IQR) 0.013-0.056%) for the 0-59 years old population, and 0.095% (IQR 0.036-0.119%) for the 0-69 years old. The median IFR was 0.0003% at 0-19 years, 0.002% at 20-29 years, 0.011% at 30-39 years, 0.035% at 40-49 years, 0.123% at 50-59 years, and 0.506% at 60-69 years. IFR increases approximately 4 times every 10 years. Including data from another 9 countries with imputed age distribution of COVID-19 deaths yielded median IFR of 0.025-0.032% for 0-59 years and 0.063-0.082% for 0-69 years. Meta-regression analyses also suggested global IFR of 0.03% and 0.07%, respectively in these age groups. The current analysis suggests a much lower pre-vaccination IFR in non-elderly populations than previously suggested. Large differences did exist between countries and may reflect differences in comorbidities and other factors. These estimates provide a baseline from which to fathom further IFR declines with the widespread use of vaccination, prior infections, and evolution of new variants.
Subject(s)
COVID-19 , Adolescent , Adult , Child , Child, Preschool , Humans , Infant , Infant, Newborn , Middle Aged , Young Adult , Comorbidity , COVID-19/epidemiology , SARS-CoV-2 , Seroepidemiologic Studies , VaccinationABSTRACT
Hand-Foot syndrome (HFS) and diarrhoea are dose-limiting Adverse Drug Reactions (ADRs) of capecitabine-based chemotherapy. Four polymorphisms in the dihydropyrimidine dehydrogenase (DPYD) gene, encoding the DPD enzyme responsible for the metabolism of fluoropyrimidines, such as capecitabine, are strongly associated with severe ADRs, and their screening should be performed before starting treatment. Moreover, capecitabine-related toxicity may worsen due to drug-drug and drug-supplement interactions. Here we investigated factors responsible for severe HFS and diarrhoea presented by two patients, non-carriers of the recommended DPYD single nucleotide polymorphisms (SNPs) but carriers of other genetic variants suggested to increase the risk of capecitabine-related ADRs. Through careful therapy recognition, we demonstrated that, unbeknownst to the oncologists, the patients were taking folic acid during the treatment with capecitabine at a dosage higher than 2000 mg/m2, which is the maximum tolerated dose when folate is administered. To resolve the ADRs, the therapy had to be drastically changed. In one case, dose reduction of capecitabine and discontinuation of lipid-lowering agents were carried out. In the other case, discontinuation of capecitabine and folic acid and capecitabine re-administration were performed after a month. Genetic and environmental factors should be considered good predictors of severe capecitabine-related toxicity. Medication reconciliation should be encouraged to avoid the harmful consequences of inappropriate treatments.
ABSTRACT
BACKGROUND: Influenza is a major cause of morbidity, mortality and exacerbation of extant chronic disease worldwide. Influenza vaccination is thus fundamental to reduce the burden of disease. In this study, we describe the trend of influenza vaccination coverage in the seasons 2010/11-2020/21 among children aged < 2, 2-4 and 5-8 in Italy. METHODS: We analyzed the trend of influenza vaccination coverage in the pediatric population in Italy from the 2010/11 to the 2020/21 season at national and regional level and observed the incidence of influenza-like illness (ILI) in the pediatric population between 2010/11 and 2020/21. RESULTS: In the period 2010/11-2019/20 the highest value of coverage (4.5%) was reached in the age group 2-4 and 5-8 (season 2010/11 and 2011/12, respectively), while the lowest belonged to the < 2 group (1.1% in the season 2015/16). In the season 2020/2021 all the age groups reported a substantial increase of coverage compared with the previous season. The highest value (19.0%) was reported in the age group 2-4, followed by the group 5-8 and < 2 (13.1 and 9.2%, respectively). Considering the rates of annual ILI cases, the highest value for the 0-4 age group was 18.5% in the 2011/12 season; for the 5-14 age group, the highest value was 27.7% in the 2010/11 season. CONCLUSIONS: Over the past 11 years pediatric influenza vaccination coverage in Italy has been low, with relevant differences across regions and seasons, albeit a general increase in coverage has been observed in the 2020/21 season. Universal influenza vaccination for children should be considered as a priority for the high incidence in this age group. Further research is needed to improve knowledge and comparability of coverage rates, and to identify the best practices for organizational models of delivery which can support the improvement of trends, the acceptability and accessibility by parents and awareness in stakeholders and decision makers.
Subject(s)
Influenza Vaccines , Influenza, Human , Adolescent , Child , Child, Preschool , Humans , Infant , Infant, Newborn , Influenza, Human/epidemiology , Influenza, Human/prevention & control , Italy/epidemiology , Seasons , Vaccination , Vaccination CoverageABSTRACT
BACKGROUND AND PURPOSE: The benefit of mechanical thrombectomy (MT) in patients with acute ischemic stroke (AIS) due to large vessel occlusion (LVO) and baseline mild neurological symptoms remains unclear. The purpose of this study was to evaluate the effectiveness of MT in this subgroup of patients. METHODS: The databases of 9 high-volume Italian stroke centers were retrospectively screened for patients with LVO in the anterior circulation and a baseline National Institute of Health Stroke Scale (NIHSS) score ≤ 5 that received either immediate MT or best medical management (BMM) with the possibility of rescue MT upon neurological worsening. Primary outcome measure was a modified Rankin Scale score of 0-1 at 90 days. Propensity score matching (PSM) analysis was used to estimate the treatment effect of immediate MT compared to BMM/rescue MT. RESULTS: Two hundred and seventy-two patients received immediate MT (MT group). The BMM/rescue MT group included 41 patients. The primary outcome was achieved in 78.6% (n = 246) of overall patients, with a higher proportion in the MT group (80.5% vs. 65.9%, p = 0.03) in unadjusted analysis. After PSM, patients in the MT group had a 19.5% higher chance of excellent outcome at 90 days compared to the BMM/Rescue MT group with a similar risk of death from any cause. CONCLUSIONS: Our experience is in favor of a potential benefit of MT also in patients with LVO and a NIHSS score ≤ 5 at the time of groin puncture. Nonetheless, this issue waits for a clear-cut recommendation in a dedicated clinical trial.
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Brain Ischemia , Ischemic Stroke , Stroke , Brain Ischemia/etiology , Brain Ischemia/surgery , Humans , Retrospective Studies , Stroke/etiology , Stroke/surgery , Thrombectomy/adverse effects , Treatment OutcomeABSTRACT
OBJECTIVES: Most countries initially deployed COVID-19 vaccines preferentially in elderly populations. We aimed to evaluate whether population-level vaccine effectiveness is heralded by an increase in the relative proportion of deaths among non-elderly populations that were less covered by vaccination programs. ELIGIBLE DATA: We collected data from 40 countries on age-stratified COVID-19 deaths during the vaccination period (1/14/2021-5/31/2021) and two control periods (entire pre-vaccination period and excluding the first wave). MAIN OUTCOME MEASURES: We meta-analyzed the proportion of deaths in different age groups in vaccination versus control periods in (1) countries with low vaccination rates; (2) countries with age-independent vaccination policies; and (3) countries with standard age-dependent vaccination policies. RESULTS: Countries that prioritized vaccination among older people saw an increasing share of deaths among 0-69 year old people in the vaccination versus the two control periods (summary proportion ratio 1.32 [95 CI% 1.24-1.41] and 1.35 [95 CI% 1.26-1.44)]. No such change was seen on average in countries with age-independent vaccination policies (1.05 [95 CI% 0.78-1.41 and 0.97 [95 CI% 0.95-1.00], respectively) and limited vaccination (0.93 [95 CI% 0.85-1.01] and 0.95 [95 CI% 0.87-1.03], respectively). Proportion ratios were associated with the difference of vaccination rates in elderly versus non-elderly people. No significant changes occurred in the share of deaths in age 0-49 among all 0-69 deaths in the vaccination versus pre-vaccination periods. CONCLUSIONS: The substantial shift in the age distribution of COVID-19 deaths in countries that rapidly implemented vaccination predominantly among elderly provides evidence for the population level-effectiveness of COVID-19 vaccination and a favorable evolution of the pandemic towards endemicity with fewer elderly deaths.
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COVID-19 Vaccines , COVID-19 , Adolescent , Adult , Age Distribution , Aged , Child , Child, Preschool , Humans , Infant , Infant, Newborn , Middle Aged , SARS-CoV-2 , Vaccination , Vaccine Efficacy , Young AdultABSTRACT
Health workers, especially those in patient-facing roles, had a significantly increased risk of COVID-19 infection, having serious outcomes, and risking spreading the virus to patients and staff. Vaccination campaign planning suggests allocating initial supplies of BNT162b2 vaccine to health workers given the importance of early protection to safeguard the continuity of care to patients. The aim of the study is to assess the effectiveness and safety of BNT162b2 vaccine among the health workers of Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG). The retrospective cohort study was conducted among health staff working at the FPG. Vaccination data were collected from hospital records. The primary end points were vaccine effectiveness and safety. A total of 6649 health workers were included, of whom 5162 received injections. There were 14 cases of COVID-19 with onset at least 14 days after the second dose among vaccinated health workers and 45 cases among unvaccinated ones. BNT162b2 was 91.5% effective against COVID-19 (95% credible interval, 84.7% to 95.3%). The safety profile of BNT162b2 vaccine consisted of short-term, non-serious events. The promotion and boost of the COVID-19 vaccination campaign represents a key public health measure useful to curb the spread of the pandemic especially in vulnerable contexts, such as hospitals, where health workers carry out a paramount role for the entire community, and requires further protection with a possible booster dose in view of autumn-winter 2021.
Subject(s)
COVID-19 , Vaccines , BNT162 Vaccine , COVID-19 Vaccines , Humans , Immunization Programs , Retrospective Studies , SARS-CoV-2ABSTRACT
BACKGROUND: Patient portals are becoming increasingly popular worldwide even though their impact on individual health and health system efficiency is still unclear. OBJECTIVE: The aim of this systematic review was to summarize evidence on the impact of patient portals on health outcomes and health care efficiency, and to examine user characteristics, attitudes, and satisfaction. METHODS: We searched the PubMed and Web of Science databases for articles published from January 1, 2013, to October 31, 2019. Eligible studies were primary studies reporting on the impact of patient portal adoption in relation to health outcomes, health care efficiency, and patient attitudes and satisfaction. We excluded studies where portals were not accessible for patients and pilot studies, with the exception of articles evaluating patient attitudes. RESULTS: Overall, 3456 records were screened, and 47 articles were included. Among them, 11 studies addressed health outcomes reporting positive results, such as better monitoring of health status, improved patient-doctor interaction, and improved quality of care. Fifteen studies evaluated the impact of digital patient portals on the utilization of health services with mixed results. Patient characteristics were described in 32 studies, and it was reported that the utilization rate usually increases with age and female gender. Finally, 30 studies described attitudes and defined the main barriers (concerns about privacy and data security, and lack of time) and facilitators (access to clinical data and laboratory results) to the use of a portal. CONCLUSIONS: Evidence regarding health outcomes is generally favorable, and patient portals have the potential to enhance the doctor-patient relationship, improve health status awareness, and increase adherence to therapy. It is still unclear whether the use of patient portals improves health service utilization and efficiency.
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Patient Portals , Attitude , Electronic Health Records , Female , Humans , Outcome Assessment, Health Care , Physician-Patient RelationsABSTRACT
INTRODUCTION: Precision health requires citizens that are empowered to orient health decisions towards their personal values, aware of the benefits and risks, and committed to sharing their personal data to trustful institutions. Effective citizen engagement initiatives are fundamental for the success of a precision health approach. OBJECTIVE: To provide an overview of citizen engagement initiatives in precision health in European Union (EU) member states. DESIGN: Scoping review. METHODS: The electronic databases PubMed, Web of Science, CINAHL and Embase were searched to include articles published in English. Furthermore, desk research was conducted in English, Dutch, French, Italian and Spanish. Articles or reports regarding ongoing initiatives of citizen engagement in precision health conducted in EU member states and published from January 2015 to July 2020 were considered eligible. A quality assessment of the retrieved entries using Critical Appraisal Skills Programme tool was conducted. RESULTS: We identified nine documents, which reported eight ongoing citizen engagement initiatives, with substantial variability. Government agencies, non-governmental organisations and scientific societies were the main organisers and funders. Most of the initiatives were conducted in the UK. Genomics was the most emphasised aspect of precision health in these initiatives. Among the identified initiatives, both in-person and digital means were reported. CONCLUSION: Our work provides an overview of current citizen engagement initiatives in the EU that can be useful for stakeholders interested in designing and developing precision health projects enriched by meaningful citizen participation. PROSPERO REGISTRATION NUMBER: CRD42020193866.
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Genomics , Precision Medicine , European Union , HumansABSTRACT
OBJECTIVE: Providing new tools to improve surgical planning is considered a main goal in meningioma treatment. In this context, two factors are crucial in determining operating strategy: meningioma-brain interface and meningioma consistency. The use of intraoperative ultrasound (ioUS) elastosonography, a real-time imaging technique, has been introduced in general surgery to evaluate similar features in other pathological settings such as thyroid and prostate cancer. The aim of the present study was to evaluate ioUS elastosonography in the intraoperative prediction of key intracranial meningioma features and to evaluate its application in guiding surgical strategy. METHODS: An institutional series of 36 meningiomas studied with ioUS elastosonography is reported. Elastographic data, intraoperative surgical findings, and corresponding preoperative MRI features were classified, applying a score from 0 to 2 to both meningioma consistency and meningioma-brain interface. Statistical analysis was performed to determine the degree of agreement between meningioma elastosonographic features and surgical findings, and whether intraoperative elastosonography was a better predictor than preoperative MRI in assessing meningioma consistency and slip-brain interface, using intraoperative findings as the gold standard. RESULTS: A significantly high degree of reliability and agreement between ioUS elastographic scores and surgical finding scores was reported (intraclass correlation coefficient = 0.848, F = 12.147, p < 0.001). When analyzing both consistency and brain-tumor interface, ioUS elastography proved to have a rather elevated sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and positive (LR+) and negative likelihood ratio (LR-). This consideration was true especially for meningiomas with a hard consistency (sensitivity = 0.92, specificity = 0.96, PPV = 0.92, NPV = 0.96, LR+ = 22.00, LR- = 0.09) and for those presenting with an adherent slip-brain interface (sensitivity = 0.76, specificity = 0.95, PPV = 0.93, NPV = 0.82, LR+ = 14.3, LR- = 0.25). Furthermore, predictions derived from ioUS elastography were found to be more accurate than MRI-derived predictions, as demonstrated by McNemar's test results in both consistency (p < 0.001) and interface (p < 0.001). CONCLUSIONS: While external validation of the data is needed to transform ioUS elastography into a fully deployable clinical tool, this experience confirmed that it may be integrated into meningioma surgical planning, especially because of its rapidity and cost-effectiveness.
Subject(s)
Elasticity Imaging Techniques , Meningeal Neoplasms , Meningioma , Brain , Humans , Male , Meningeal Neoplasms/diagnostic imaging , Meningeal Neoplasms/surgery , Meningioma/diagnostic imaging , Meningioma/surgery , Reproducibility of ResultsABSTRACT
BACKGROUND: Patients' increasing needs and expectations require an overall assessment of hospital performance. Several international agencies have defined performance indicators sets but there exists no unanimous classification. The Impact HTA Horizon2020 Project wants to address this aspect, developing a toolkit of key indicators to measure hospital performance. The aim of this review is to identify and classify the dimensions of hospital performance indicators in order to develop a common language and identify a shared evidence-based way to frame and address performance assessment. METHODS: Following the PRISMA statement, PubMed, Cochrane Library and Web of Science databases were queried to perform an umbrella review. Reviews focusing on hospital settings, published January 2000-June 2019 were considered. The quality of the studies selected was assessed using the AMSTAR2 tool. RESULTS: Six reviews ranging 2002-2014 were included. The following dimensions were described in at least half of the studies: 6 studies classified efficiency (55 indicators analyzed); 5 studies classified effectiveness (13 indicators), patient centeredness (10 indicators) and safety (8 indicators); 3 studies responsive governance (2 indicators), staff orientation (10 indicators) and timeliness (4 indicators). Three reviews did not specify the indicators related to the dimensions listed, and one article gave a complete definition of the meaning of each dimension and of the related indicators. CONCLUSIONS: The research shows emphasis of the importance of patient centeredness, effectiveness, efficiency, and safety dimensions. Especially, greater attention is given to the dimensions of effectiveness and efficiency. Assessing the overall quality of clinical pathways is key in guaranteeing a truly effective and efficient system but, to date, there still exists a lack of awareness and proactivity in terms of measuring performance of nodes within networks. The effort of classifying and systematizing performance measurement techniques across hospitals is essential at the organizational, regional/national and possibly international levels to deliver top quality care to patients.