Genome tumor profiling in endometrial cancer and clinical relevance in endometrial cancer management: a retrospective single-center experience.

OBJECTIVE: Next-generation sequencing (NGS) analysis has become an essential tool for endometrial carcinoma management. Moreover, molecular-driven therapies play an increasingly remarkable role in the era of precision oncology. This study aims to determine the clinical relevance of NGS testing in endometrial carcinoma management by analyzing the clinical benefit of NGS-driven targeted therapies. METHODS: A single-center retrospective study was conducted on 25 endometrial carcinoma patients who underwent Foundation Medicine CDx assay at Fondazione Policlinico Universitario Agostino Gemelli, IRCCS (Rome, Italy). Tumor samples were analyzed by Foundation One CDx. A descriptive analysis of tumor genome profiles was performed. Assessment of clinical benefit according to RECIST 1.1 criteria was analyzed for patients who received a tailored treatment according to actionable targets identified by NGS testing. RESULTS: Out of 25 endometrial carcinoma patients, 11 received targeted therapy. One patient was excluded from the clinical benefit assessment because of COVID-19-related death 1 month after starting the treatment. Eight of the remaining 10 patients benefited from targeted therapies, with an overall clinical benefit rate of 80%. A targeted agent belonging to the PI3K pathway was given to seven patients, with evidence of three partial responses (42.9%), three stable diseases (42.9%), and one progressive disease (14.2%) according to RECIST 1.1 criteria. One complete response (33.3%), one stable disease (33.3%), and one progressive disease (33.3%) were observed in the three patients treated with poly(ADP-ribose) polymerase (PARP) inhibitors according to their homologous recombination deficiency (HRD) status. CONCLUSION: This study highlights the importance of characterizing the mutation profile of patient tumors through NGS. Our findings suggest a clinical benefit of using NGS-driven targeted therapies in endometrial carcinoma patients. However, this personalized approach could benefit the health system in terms of cost-effectiveness by reducing the costs of inappropriate, ineffective, and often expensive treatments.

SARS-CoV-2 IgG "heritage" in newborn: A credit of maternal natural infection.

Description of transplacental passage of specific SARS-CoV-2 IgG from mothers who contracted natural infection to their newborns. Retrospective cohort analysis including pregnant women diagnosed with SARS-CoV-2 and their newborns both tested for SARS-CoV-2 specific IgG and IgM with antibody titration at delivery. Nasopharyngeal swab were taken from both mothers and neonates, and tested for SARS-CoV-2 using polymerase chain reaction (PCR). IgM and IgG were analyzed in maternal and neonatal serum of 143 mother-infant dyads. 86% of women with a positive SARS-CoV-2 PCR >14 days before delivery developed specific IgG and 84% of their infants showed transplacental passage of IgG. Pregnant women infected with SARS-CoV-2 achieve antibody seroconversion following the kinetics described in the general population, and transplacental transfer of IgG specific antibodies occurs. No conclusion can be drawn on passive immunity efficacy or duration.

Is There a Role for SARS-CoV-2/COVID-19 on the Female Reproductive System?

Coronavirus disease (COVID-19) has emerged as a very serious pandemic caused by the rapidly evolving transmission of the coronavirus SARS-CoV-2. Since its outbreak in 2020, the SARS CoV-2 has represented an important challenge for the physicians due to its well known respiratory sequelae. To date, the role of SARS-CoV-2 infection on organs and systems other than lungs and respiratory tract remains less clear. In particular, it remains to be investigated whether the reproductive system can be affected by the SARS-CoV-2 in the long term-period or, in alternative, drugs used to treat COVID-19 might impact the reproductive systems and, in turn, fertility. What is known is that SARS-Cov-2 binds to target cells of host through different receptors including angiotensin-converting enzyme 2 (ACE2), neuropilin-1, AXL and antibody-FcɣR complexes. ACE2 physiologically regulates both the expression of angiotensin II (Ang II) as well as Ang-(1-7) to exerts its physiological functions. The reproductive system abundantly expresses ACE2 and produces Ang-(1-7), starting from precursors which are locally generated or derived from systemic circulation. Ang-(1-7) plays an important role of stimulus to the growth and maturation of ovarian follicle as well as to ovulation. Also human endometrium expresses Ang-(1-7), mainly during the post-ovulatory phase. Animal and human observational studies demonstrated that Ang-(1-7) is involved in the maternal immune response to pregnancy and its deficiency is associated with a defective placenta development. In our manuscript, we review the current knowledge about whether SARS-CoV-2 may impact the female reproductive system. We further explain the possible molecular mechanism by which SARS-CoV-2 might affect ovarian, endometrial and female genital tract cells.

The impact of COVID-19 pandemic on patterns of care of endometrial cancer patients

Introduction/BackgroundCOVID-19 outbreak has correlated with the disruption of screening activities, regular follow up visits, and diagnostic assessments. The risk of misdiagnosis and delayed diagnosis has consequently increased during the pandemic. Endometrial cancer is one of the most common gynecological malignancies and it is often detected at an early stage, because it frequently produces symptoms (e.g. abnormal vaginal bleeding). Here, we aim to investigate the impact of COVID-19 outbreak on patterns of presentation and treatment of endometrial cancer patients.MethodologyThis is a retrospective study involving 53 centers in Italy. We evaluated patterns of presentation and treatment of endometrial cancer patients before (period 1: from 03/01/2019 to 02/29/2020) and during (period 2: from 01/04/2020 to 3/31/2021) the COVID-19 outbreak.ResultsMedical records of 5,117 endometrial cancer patients have been retrieved: 2,688 and 2,429 women treated in period 1 and period 2, respectively. The prevalence of endometrioid International Federation of Obstetrics and Gynecologists (FIGO) grade 1, 2, and 3 was consistent over the study period (p=0.769). However, the prevalence of non-endometrioid endometrial cancer was lower in period 1 than in period 2 (15.7% vs. 17.9%;p=0.015). Nodal assessment was omitted in 684 (27.3%) and 478 (21%) patients treated in period 1 and 2, respectively (p<0.001). While, the prevalence of patients undergoing sentinel node mapping (with or without backup lymphadenectomy) has increased during the COVID-19 pandemic (46.8% in period 1 vs. 53.1% in period 2;p<0.001). Adjuvant therapy was omitted in 1,269 (50.5%) and 1,019 (44.9%) patients receiving treatment in period 1 and 2, respectively (p<0.001). Adjuvant therapy use has increased during the COVID-19 pandemic (p<0.001).ConclusionOur data suggest that the COVID-19 pandemic had a significant impact on the characteristics and patterns of care of endometrial cancer patients. These results highlight the need to implement healthcare services during the pandemic.

Risk perception and affective state on work exhaustion in obstetrics during the COVID-19 pandemic

A multicenter cross-sectional survey study involving four Italian University Hospitals was performed to test the hypothesis that negative affect and positive affect (affective dimensions) mediate the association between risk perception (perceived risk of infection and death;cognitive dimensions) and the feeling of work exhaustion (WE) among obstetrics healthcare providers (HCPs) during the Coronavirus Disease 2019 (COVID-19) pandemic. Totally, 570 obstetrics HCPs were invited to complete the 104-item IPSICO survey in May 2020. A theoretical model built on the tested hypothesis was investigated by structural equation modelling. The model explained 32.2% of the WE variance. Only negative affect mediated the association between cognitive dimensions and WE and also the association between WE and psychological well-being before the pandemic, experiences of stressful events, female gender, and dysfunctional coping. Non-mediated associations with WE were observed for work perceived as a duty, experience of stressful events, support received by colleagues, and the shift strategy. Only previous psychological well-being, support by colleagues, and shift strategies were inversely associated with WE. Based on study results, monitoring negative than positive affect appears superior in predicting WE, with practical implications for planning psychological interventions in HCPs at the individual, interpersonal, and organizational levels.

Open Innovation as the Catalyst in the Personalized Medicine to Personalized Digital Medicine Transition.

Personalized medicine (PM) bridges several disciplines for understanding and addressing prevalent, complex, or rare situations in human health (e.g., complex phenotyping, risk stratification, etc.); therefore, digital and technological solutions have been integrated in the field to boost innovation and new knowledge generation. The open innovation (OI) paradigm proposes a method by which to respectfully manage disruptive change in biomedical organizations, as experienced by many organizations during digital transformation and the COVID-19 pandemic. In this article, we focus on how this paradigm has catalyzed the transition from PM to personalized digital medicine in a large-volume research hospital. Methods, challenges, and results are discussed. This case study is an endeavor to confirm that OI strategies could help manage urgent needs from the healthcare environment, while achieving sustainability-oriented, accountable innovation.

Medi-Cinema: A Pilot Study on Cinematherapy and Cancer as A New Psychological Approach on 30 Gynecological Oncological Patients.

BACKGROUND: Several subjects affected by cancer experience a significant level of multidimensional disease. This longitudinal study aims to evaluate the effectiveness of psycho-oncological support using Cinema as an emotional mediator and to promote perceived well-being by personalized psychological treatment. METHODS: Thirty women diagnosed with gynecological cancer watched 12 movies and participated in a psychotherapy group co-conducted by two psychotherapists. Patients completed nine questionnaires at T0 (baseline), T1 (3 months) and T2 (6 months). RESULTS: Patients observed significant improvements (CORE-OM: p < 0.001) in psychological well-being. The results showed statistically significant differences, even in several other dimensions, such as Anxiety (STAY-Y1-2: p < 0.001), Empathy (BEES, p < 0.001), Coping (COPE: p < 0.001), QoL (QLQ-C30, p: 0.026), couple relationship (DAS, Satisfaction: p: 0.013; Cohesion: p: 0.004) and alexithymia (TAS-20, Difficulty Identifying Feeling: p: 0.002; Externally-Oriented Thinking: p: 0.003). CONCLUSIONS: The data show that cinema, as an innovative psychological approach, could be a valid instrument to support patients in oncological pathways as well as facilitating the process of recognizing themselves in other patients and communicating about their own feelings.

Is There a Role for SARS-CoV-2/COVID-19 on the Female Reproductive System?

Coronavirus disease (COVID-19) has emerged as a very serious pandemic caused by the rapidly evolving transmission of the coronavirus SARS-CoV-2. Since its outbreak in 2020, the SARS CoV-2 has represented an important challenge for the physicians due to its well known respiratory sequelae. To date, the role of SARS-CoV-2 infection on organs and systems other than lungs and respiratory tract remains less clear. In particular, it remains to be investigated whether the reproductive system can be affected by the SARS-CoV-2 in the long term-period or, in alternative, drugs used to treat COVID-19 might impact the reproductive systems and, in turn, fertility. What is known is that SARS-Cov-2 binds to target cells of host through different receptors including angiotensin-converting enzyme 2 (ACE2), neuropilin-1, AXL and antibody-FcɣR complexes. ACE2 physiologically regulates both the expression of angiotensin II (Ang II) as well as Ang-(1-7) to exerts its physiological functions. The reproductive system abundantly expresses ACE2 and produces Ang-(1-7), starting from precursors which are locally generated or derived from systemic circulation. Ang-(1-7) plays an important role of stimulus to the growth and maturation of ovarian follicle as well as to ovulation. Also human endometrium expresses Ang-(1-7), mainly during the post-ovulatory phase. Animal and human observational studies demonstrated that Ang-(1-7) is involved in the maternal immune response to pregnancy and its deficiency is associated with a defective placenta development. In our manuscript, we review the current knowledge about whether SARS-CoV-2 may impact the female reproductive system. We further explain the possible molecular mechanism by which SARS-CoV-2 might affect ovarian, endometrial and female genital tract cells.

Vertical Transmission of SARS-CoV-2 during Pregnancy: A Prospective Italian Cohort Study.

OBJECTIVE: The extent of vertical transmission (VT) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from mothers their fetuses or neonates is still uncertain. We aimed to determine the incidence of VT. STUDY DESIGN: In this prospective cohort study. All mother diagnosed with SARS-CoV-2 infection at the time of delivery or up to 1 week prior and their neonates, managed in a tertiary referral hospital for pregnancy complicated by coronavirus disease 2019 (COVID-19) in Rome, from April 2 to December 22, 2020, were included. Maternal infection was defined as nasopharyngeal swab test results positive for SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR). Biological samples were collected before, at, and after delivery to test positivity for SARS-CoV-2 RT-PCR and anti-SARS-CoV-2-specific antibodies. RESULTS: The cohort included 95 women and 96 neonates with documented SARS-CoV-2 test results. Four neonates (4.2%) tested positive. The incidence of VT, according to the guidance criteria for diagnosing perinatal SARS-CoV-2 infection, was 5.2%. Neonatal symptoms were due to prematurity or fetal distress: symptomatic infants had lower median (min-max) gestational age, 38.1 (29.3-40.6) versus 39.3 (33.9-41.9) weeks (p = 0.036), and 1-minute and 5-minute Apgar scores, 9 (3-9) versus 9 (7-10) (p = 0.036) and 10 (6-10) versus 10 (8-10) (p = 0.012), respectively, than asymptomatic infants and needed more frequent assistance in the delivery room (22.2 vs 2.5%; p = 0.008). Only six (7.1%) neonates had anti-SARS-CoV-2-specific antibodies, despite the ongoing maternal infection. CONCLUSION: The incidence of VT is low as is the detection of specific anti-SARS-CoV-2 antibodies in cord blood when infection is contracted late in pregnancy. This would suggest poor protection of infants against horizontal transmission of the virus. KEY POINTS: · VT of SARS-CoV-2 from pregnant mothers to fetuses or neonates can be possible.. · In this prospective cohort study, the incidence of VT is found to be 5.2%.. · VT is low but exists..

A real-time integrated framework to support clinical decision making for covid-19 patients.

BACKGROUND: The COVID-19 pandemic affected healthcare systems worldwide. Predictive models developed by Artificial Intelligence (AI) and based on timely, centralized and standardized real world patient data could improve management of COVID-19 to achieve better clinical outcomes. The objectives of this manuscript are to describe the structure and technologies used to construct a COVID-19 Data Mart architecture and to present how a large hospital has tackled the challenge of supporting daily management of COVID-19 pandemic emergency, by creating a strong retrospective knowledge base, a real time environment and integrated information dashboard for daily practice and early identification of critical condition at patient level. This framework is also used as an informative, continuously enriched data lake, which is a base for several on-going predictive studies. METHODS: The information technology framework for clinical practice and research was described. It was developed using SAS Institute software analytics tool and SAS® Vyia® environment and Open-Source environment R ® and Python ® for fast prototyping and modeling. The included variables and the source extraction procedures were presented. RESULTS: The Data Mart covers a retrospective cohort of 5528 patients with SARS-CoV-2 infection. People who died were older, had more comorbidities, reported more frequently dyspnea at onset, had higher d-dimer, C-reactive protein and urea nitrogen. The dashboard was developed to support the management of COVID-19 patients at three levels: hospital, single ward and individual care level. INTERPRETATION: The COVID-19 Data Mart based on integration of a large collection of clinical data and an AI-based integrated framework has been developed, based on a set of automated procedures for data mining and retrieval, transformation and integration, and has been embedded in the clinical practice to help managing daily care. Benefits from the availability of a Data Mart include the opportunity to build predictive models with a machine learning approach to identify undescribed clinical phenotypes and to foster hospital networks. A real-time updated dashboard built from the Data Mart may represent a valid tool for a better knowledge of epidemiological and clinical features of COVID-19, especially when multiple waves are observed, as well as for epidemic and pandemic events of the same nature (e. g. with critical clinical conditions leading to severe pulmonary inflammation). Therefore, we believe the approach presented in this paper may find several applications in comparable situations even at region or state levels. Finally, models predicting the course of future waves or new pandemics could largely benefit from network of DataMarts.

Building a Personalized Medicine Infrastructure for Gynecological Oncology Patients in a High-Volume Hospital.

Gynecological cancers require complex intervention since patients have specific needs to be addressed. Centralization to high-volume centers improves the oncological outcomes of patients with gynecological cancers. Research in gynecological oncology is increasing thanks to modern technologies, from the comprehensive molecular characterization of tumors and individual pathophenotypes. Ongoing studies are focusing on personalizing therapies by integrating information across genomics, proteomics, and metabolomics with the genetic makeup and immune system of the patient. Hence, several challenges must be faced to provide holistic benefit to the patient. Personalized approaches should also recognize the unmet needs of each patient to successfully deliver the promise of personalized care, in a multidisciplinary effort. This may provide the greatest opportunity to improve patients' outcomes. Starting from a narrative review on gynecological oncology patients' needs, this article focuses on the experience of building a research and care infrastructure for personalized patient management.

Characteristics and patterns of care of endometrial cancer before and during COVID-19 pandemic.

OBJECTIVE: Coronavirus disease 2019 (COVID-19) outbreak has correlated with the disruption of screening activities and diagnostic assessments. Endometrial cancer (EC) is one of the most common gynecological malignancies and it is often detected at an early stage, because it frequently produces symptoms. Here, we aim to investigate the impact of COVID-19 outbreak on patterns of presentation and treatment of EC patients. METHODS: This is a retrospective study involving 54 centers in Italy. We evaluated patterns of presentation and treatment of EC patients before (period 1: March 1, 2019 to February 29, 2020) and during (period 2: April 1, 2020 to March 31, 2021) the COVID-19 outbreak. RESULTS: Medical records of 5,164 EC patients have been retrieved: 2,718 and 2,446 women treated in period 1 and period 2, respectively. Surgery was the mainstay of treatment in both periods (p=0.356). Nodal assessment was omitted in 689 (27.3%) and 484 (21.2%) patients treated in period 1 and 2, respectively (p<0.001). While, the prevalence of patients undergoing sentinel node mapping (with or without backup lymphadenectomy) has increased during the COVID-19 pandemic (46.7% in period 1 vs. 52.8% in period 2; p<0.001). Overall, 1,280 (50.4%) and 1,021 (44.7%) patients had no adjuvant therapy in period 1 and 2, respectively (p<0.001). Adjuvant therapy use has increased during COVID-19 pandemic (p<0.001). CONCLUSION: Our data suggest that the COVID-19 pandemic had a significant impact on the characteristics and patterns of care of EC patients. These findings highlight the need to implement healthcare services during the pandemic.

Clinical impact of SARS-CoV-2 infection among patients with vulvar cancer: the Gemelli Vul.Can multidisciplinary team.

BACKGROUND: 'Severe acute respiratory syndrome coronavirus-2' (SARS-CoV-2) infection has dramatically affected the management of patients with cancer, who are most vulnerable to the consequences of the infection. Patients with vulvar cancer are frequently elderly and affected by multiple co-morbidities, thus representing a particularly frail population. OBJECTIVE: To assess the clinical impact of the SARS-CoV-2 infection among patients scheduled for treatment for active vulvar cancer. METHODS: Data on patients with vulvar tumors referred to Fondazione Policlinico Universitario Agostino Gemelli IRCCS between February 2020 and July 2021 were retrospectively analyzed. Patients with a positive reverse transcription polymerase chain reaction in nasopharyngeal swab were considered as positive for SARS-Cov-2. RESULTS: One hundred and ninety-one patients with vulvar cancer were evaluated and scheduled for treatment. The median age was 72 years (range 35-94). Seven (3.7%) patients were diagnosed with SARS-Cov-2 infection: three (42.9%) had their treatment delayed, with no apparent consequences, two (28.6%) had their treatment delayed and later abandoned because of clinical worsening due to oncologic disease progression, and two (28.6%) contracted the infection in the post-operative period and died due to respiratory complications. CONCLUSIONS: In most cases the infection had major clinical implications, being associated with significant delays in oncologic treatments and extremely high mortality when contracted in the post-operative period.

A machine-learning parsimonious multivariable predictive model of mortality risk in patients with Covid-19.

The COVID-19 pandemic is impressively challenging the healthcare system. Several prognostic models have been validated but few of them are implemented in daily practice. The objective of the study was to validate a machine-learning risk prediction model using easy-to-obtain parameters to help to identify patients with COVID-19 who are at higher risk of death. The training cohort included all patients admitted to Fondazione Policlinico Gemelli with COVID-19 from March 5, 2020, to November 5, 2020. Afterward, the model was tested on all patients admitted to the same hospital with COVID-19 from November 6, 2020, to February 5, 2021. The primary outcome was in-hospital case-fatality risk. The out-of-sample performance of the model was estimated from the training set in terms of Area under the Receiving Operator Curve (AUROC) and classification matrix statistics by averaging the results of fivefold cross validation repeated 3-times and comparing the results with those obtained on the test set. An explanation analysis of the model, based on the SHapley Additive exPlanations (SHAP), is also presented. To assess the subsequent time evolution, the change in paO2/FiO2 (P/F) at 48 h after the baseline measurement was plotted against its baseline value. Among the 921 patients included in the training cohort, 120 died (13%). Variables selected for the model were age, platelet count, SpO2, blood urea nitrogen (BUN), hemoglobin, C-reactive protein, neutrophil count, and sodium. The results of the fivefold cross-validation repeated 3-times gave AUROC of 0.87, and statistics of the classification matrix to the Youden index as follows: sensitivity 0.840, specificity 0.774, negative predictive value 0.971. Then, the model was tested on a new population (n = 1463) in which the case-fatality rate was 22.6%. The test model showed AUROC 0.818, sensitivity 0.813, specificity 0.650, negative predictive value 0.922. Considering the first quartile of the predicted risk score (low-risk score group), the case-fatality rate was 1.6%, 17.8% in the second and third quartile (high-risk score group) and 53.5% in the fourth quartile (very high-risk score group). The three risk score groups showed good discrimination for the P/F value at admission, and a positive correlation was found for the low-risk class to P/F at 48 h after admission (adjusted R-squared = 0.48). We developed a predictive model of death for people with SARS-CoV-2 infection by including only easy-to-obtain variables (abnormal blood count, BUN, C-reactive protein, sodium and lower SpO2). It demonstrated good accuracy and high power of discrimination. The simplicity of the model makes the risk prediction applicable for patients in the Emergency Department, or during hospitalization. Although it is reasonable to assume that the model is also applicable in not-hospitalized persons, only appropriate studies can assess the accuracy of the model also for persons at home.

Flu and Tdap Maternal Immunization Hesitancy in Times of COVID-19: An Italian Survey on Multiethnic Sample.

BACKGROUND: Tdap and flu immunization in pregnancy has been proven to be both effective and safe. Despite this, the vaccination rate in pregnant women is low in Italy. The COVID-19 pandemic has focused the attention of public opinion on communicable diseases, underlining the importance of primary prevention measures such as vaccination. We conducted a survey to investigate the behavior of pregnant women during the COVID-19 pandemic regarding maternal immunization to identify the reasons for vaccine hesitancy in order to overcome them. The new challenge is COVID-19 vaccination in pregnancy, and preliminary data show hesitancy towards it. Our analysis may be useful to improve immunization in the pregnant population, including through the COVID-19 vaccine. METHODS: A targeted survey was performed in Italy including 520 women who experienced in the first trimester of pregnancy, prior to the novel coronavirus spread, the 2019-2020 influenza vaccination campaign and the Tdap vaccine recommendation in the third trimester during the COVID pandemic. They represent a unique model to investigate if the new coronavirus outbreak might have changed attitudes towards vaccination in pregnancy in the same patients. Data were collected from a self-completed paper questionnaire. Descriptive statistics were calculated and percentages were compared using the chi-2 test or Fisher's exact test. RESULTS: We obtained data from 195 of the 520 women who gave birth during the inclusion period; 325 cases declined to participate in the survey. A total of 8.7% (17 cases) performed flu vaccination in the first trimester of pregnancy (pre-COVID era), 50.8% (99 cases) accepted Tdap immunization during their third trimester of gestation (COVID-19 pandemic) and 6.7% (13 cases) received both vaccines during pregnancy. For both the flu and Tdap shots, pregnant patients were more likely to accept the vaccines if they were recommended by a healthcare provider, whereas the main reason not to be vaccinated was the lack of such a recommendation. CONCLUSIONS: Our survey shows that the COVID-19 experience, which has raised awareness as to the role of vaccines in preventable diseases, may positively change attitudes toward immunization in pregnancy. Vaccination must be recommended to all pregnant women and organized during routine prenatal care as an important element for the prevention of communicable diseases. Vaccination hesitancy can be minimized through consistent recommendation to all pregnant women offered by obstetric staff during routine prenatal care. This approach is likely to be effective in terms of building trust in flu and Tdpa immunization among pregnant women, as well as to avoid unjustified hesitancy towards the more recent COVID-19 vaccines.

Practice changes in Italian Gynaecologic Units during the COVID-19 pandemic: a survey study.

The impact of Coronavirus disease 2019 pandemic on Italian Gynaecological Units practice and the compliance and satisfaction with available guidelines/recommendations is unknown. Therefore, a survey was conducted among all Italian Gynaecological Units Directors in April 2020. The response rate was 90% (135/150). 77.8% of centres performed surgery only for oncologic or not deferrable pathologies, and 9.6% was closed. 68.7% of directors were at least moderately satisfied by published guidelines/recommendations, but 94.8% of respondents identified limitations, mainly (83%) the absent definition of benign non-deferrable pathology. Responders considered as non-deferrable severe endometriosis (69.6%), endometriosis with organ failure/dysfunction (74.1%), and unresponsive symptomatic fibroids (89.6%). Despite guidelines/recommendations, respondents treated ovarian (77%) and endometrial (71.6%) cancer as usual. Only a minority of respondents reduced the laparoscopic approach (11.2%) and adopted all recommended surgical precautions (9.6%). Compliance with available guidelines/recommendations appears incomplete. Reconsidering guidelines/recommendations regarding oncological cases and specify non-deferrable benign pathologies would improve guidelines/recommendations compliance.Impact statementWhat is already known on this subject? The SARS-CoV-2 pandemic has profoundly influenced medical routine practice worldwide. Surgery units have been forced to reduce or even completely restrict their activity to re-allocate human resources. Many major international gynaecological societies have released statements and guidelines, providing various recommendations to guide practice changes. However, the impact of the SARS-CoV-2 pandemic on Italian Gynaecological Units practice and the compliance and satisfaction with available guidelines/recommendations is unknown.What do the results of this study add? Study results provide evidence showing how the SARS-CoV-2 pandemic has changed surgical activity in the Italian Gynaecological Units. Most centres reduced surgical activity, limiting surgery only for oncologic or not deferrable pathologies. Moreover, our research shows the level of compliance and satisfaction with available guidelines/recommendations and where they need to be improved. Most directors were at least moderately satisfied but identified different limitations. Guidelines/recommendations do not provide enough details, such as the absent definition of benign non-deferrable pathologies.What are the implications of these findings for clinical practice and/or further research? The limited compliance with available guidelines/recommendations and identified limitations suggest reconsidering guidelines/recommendations focussing on identified gaps. Provide more details, such as specifying non-deferrable benign pathologies, would improve guidelines/recommendations compliance.

The Psychological Impact of COVID-19 on Healthcare Providers in Obstetrics: A Cross-Sectional Survey Study.

Objective: To assess the psychological distress of healthcare providers (HCPs) working in the field of obstetrics during the coronavirus disease 2019 (COVID-19) pandemic and to identify factors associated with psychological distress at the individual, interpersonal, and organizational level. Design: Cross-sectional survey study. Setting: Four University hospitals in Italy. Participants: HCPs working in obstetrics, including gynecologists, residents in gynecology and obstetrics, and midwives. Methods: The 104-item survey Impatto PSIcologico COVID-19 in Ostetricia (IPSICO) was created by a multidisciplinary expert panel and administered to HCPs in obstetrics in May 2020 via a web-based platform. Main Outcome Measures: Psychological distress assessed by the General Health Questionnaire-12 (GHQ-12) included in the IPSICO survey. Results: The response rate to the IPSICO survey was 88.2% (503/570), and that for GHQ-12 was 84.4% (481/570). Just over half (51.1%; 246/481) of the GHQ-12 respondents reported a clinically significant level of psychological distress (GHQ-12 ≥3). Psychological distress was associated with either individual (i.e., female gender, stressful experience related to COVID-19, exhaustion, and the use of dysfunctional coping strategies), interpersonal (i.e., lower family support, limitations in interactions with colleagues), and organizational (i.e., reduced perception of protection by personal protective equipment, perceived delays on updates and gaps in information on the pandemic) factors in dealing with the pandemic. Conclusions: Results confirm the need for monitoring and assessing the psychological distress for HCPs in obstetrics. Interventions at the individual, interpersonal, and organizational level may relieve the psychological distress during the COVID-19 pandemic and foster resilience skills in facing emotional distress.

Medical treatment of patients with gynecologic cancer during the COVID-19 pandemic.

BACKGROUND: During the COVID-19 pandemic, cancer care had to be reorganized; national and international recommendations were published to manage anticancer treatments safely and to reduce the risk of SARS-CoV-2 infection for patients and health workers. OBJECTIVE: To evaluate whether the adoption of recommendations for the management of patients with gynaecologic cancer receiving treatment during the pandemic resulted in containment of infections and continuing oncologic care. METHODS: Based on the published recommendations, and according to the local Health Direction guidelines, we developed and drafted a security protocol to modify access of patients with gynaecologic cancer to the "Fondazione Policlinico Agostino Gemelli-IRCCS, Rome" between February 1 and April 30, 2020 and compared results with the corresponding 3 months of 2019. RESULTS: Between February and April 2019, we registered 3254 admissions, including 2253 patients receiving intravenous chemotherapies, 298 receiving oral therapies, and 703 having hospital visits. Between February and April 2020, we registered 3213 admissions, including 2221 patients receiving intravenous chemotherapies, 401 receiving oral therapies, and 591 having hospital visits. Oral treatments and general visits were different in the two time periods (p<0.001). Despite the elevated patient flow, only one patient (0.1%) tested positive for COVID-19 and there were no cases among healthcare staff. CONCLUSIONS: Based on the adopted security protocol we provided continuity of care for all patients and limited the spread of the COVID-19 infection.

Contactless: a new personalised telehealth model in chronic pediatric diseases and disability during the COVID-19 era.

BACKGROUND: Suspending ordinary care activities during the COVID-19 pandemic made it necessary to find alternative routes to comply with care recommendations not only for acute health needs but also for patients requiring follow-up and multidisciplinary visits. We present the 'Contactless' model, a comprehensive operational tool including a plurality of services delivered remotely, structured according to a complexity gradient, aimed to cover diagnostic procedures and monitor disease progression in chronic pediatric patients. METHODS: A multidisciplinary and multiprofessional project team was recruited, in collaboration with patients' associations, to map a panel of available Evidence-Based solutions and address individual needs in full respect of the concept of personalized medicine. The solutions include a number of services from videoconsultations to more structure videotraining sessions. RESULTS: A modular framework made up of four three Macro-levels of complexity - Contactless Basic, Intermediate and Advanced - was displayed as an incremental set of services and operational planning establishing each phase, from factors influencing eligibility to the delivery of the most accurate and complex levels of care. CONCLUSION: The multimodal, multidisciplinary 'Contactless' model allowed the inclusion of all Units of our Pediatric Department and families with children with disability or complex chronic conditions. The strengths of this project rely on its replicability outside of pediatrics and in the limited resources needed to practically impact patients, caregivers and professionals involved in the process of care. Its implementation in the future may contribute to reduce the duration of hospital admissions, money and parental absence from work.

Outcome of coronavirus spectrum infections (SARS, MERS, COVID-19) during pregnancy: a systematic review and meta-analysis.

Objective: The aim of this systematic review was to report pregnancy and perinatal outcomes of coronavirus spectrum infections, and particularly coronavirus 2019 (COVID-19) disease because of severe acute respiratory syndrome-coronavirus-2 infection during pregnancy. Data Sources: Medline, Embase, Cinahl, and Clinicaltrials.gov databases were searched electronically utilizing combinations of word variants for coronavirus or severe acute respiratory syndrome or SARS or Middle East respiratory syndrome or MERS or COVID-19 and pregnancy. The search and selection criteria were restricted to English language. Study Eligibility Criteria: Inclusion criteria were hospitalized pregnant women with a confirmed coronavirus related-illness, defined as severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), or COVID-19. Study Appraisal and Synthesis Methods: We used meta-analyses of proportions to combine data and reported pooled proportions, so that a pooled proportion may not coincide with the actual raw proportion in the results. The pregnancy outcomes observed included miscarriage, preterm birth, preeclampsia, preterm prelabor rupture of membranes, fetal growth restriction, and mode of delivery. The perinatal outcomes observed were fetal distress, Apgar score <7 at 5 minutes, neonatal asphyxia, admission to a neonatal intensive care unit, perinatal death, and evidence of vertical transmission. Results: Nineteen studies including 79 hospitalized women were eligible for this systematic review: 41 pregnancies (51.9%) affected by COVID-19, 12 (15.2%) by MERS, and 26 (32.9%) by SARS. An overt diagnosis of pneumonia was made in 91.8%, and the most common symptoms were fever (82.6%), cough (57.1%), and dyspnea (27.0%). For all coronavirus infections, the pooled proportion of miscarriage was 64.7% (8/12; 95% confidence interval, 37.9-87.3), although reported only for women affected by SARS in two studies with no control group; the pooled proportion of preterm birth <37 weeks was 24.3% (14/56; 95% confidence interval, 12.5-38.6); premature prelabor rupture of membranes occurred in 20.7% (6/34; 95% confidence interval, 9.5-34.9), preeclampsia in 16.2% (2/19; 95% confidence interval, 4.2-34.1), and fetal growth restriction in 11.7% (2/29; 95% confidence interval, 3.2-24.4), although reported only for women affected by SARS; 84% (50/58) were delivered by cesarean; the pooled proportion of perinatal death was 11.1% (5/60; 95% confidence interval, 84.8-19.6), and 57.2% of newborns (3/12; 95% confidence interval, 3.6-99.8) were admitted to the neonatal intensive care unit. When focusing on COVID-19, the most common adverse pregnancy outcome was preterm birth <37 weeks, occurring in 41.1% of cases (14/32; 95% confidence interval, 25.6-57.6), while the pooled proportion of perinatal death was 7.0% (2/41; 95% confidence interval, 1.4-16.3). None of the 41 newborns assessed showed clinical signs of vertical transmission. Conclusion: In hospitalized mothers infected with coronavirus infections, including COVID-19, >90% of whom also had pneumonia, preterm birth is the most common adverse pregnancy outcome. COVID-19 infection was associated with higher rate (and pooled proportions) of preterm birth, preeclampsia, cesarean, and perinatal death. There have been no published cases of clinical evidence of vertical transmission. Evidence is accumulating rapidly, so these data may need to be updated soon. The findings from this study can guide and enhance prenatal counseling of women with COVID-19 infection occurring during pregnancy, although they should be interpreted with caution in view of the very small number of included cases.