Optimal Medical Care Research Articles

Application of non-negative matrix factorization in oncology: one approach for establishing precision medicine.

The increase in the expectations of artificial intelligence (AI) technology has led to machine learning technology being actively used in the medical field. Non-negative matrix factorization (NMF) is a machine learning technique used for image analysis, speech recognition, and language processing; recently, it is being applied to medical research. Precision medicine, wherein important information is extracted from large-scale medical data to provide optimal medical care for every individual, is considered important in medical policies globally, and the application of machine learning techniques to this end is being handled in several ways. NMF is also introduced differently because of the characteristics of its algorithms. In this review, the importance of NMF in the field of medicine, with a focus on the field of oncology, is described by explaining the mathematical science of NMF and the characteristics of the algorithm, providing examples of how NMF can be used to establish precision medicine, and presenting the challenges of NMF. Finally, the direction regarding the effective use of NMF in the field of oncology is also discussed.

Reproductive Attitudes and Sexual Behavior of Women and Men Living with HIV

An anonymous survey was conducted, covering the issues of reproductive attitudes and contraceptive behavior in 50 women (mean age of 30.9±4.5 years) and 35 men (mean age of 31.1±3.2 years) with HIV infection of stages 4B and 4C. The study was carried out using a structured questionnaire that included questions about age, marital status, methods of contraception, reproductive plans, and reproductive and medical history. An anonymous interview with 85 HIV-infected respondents revealed that most of the women (82.0%) had contracted HIV through heterosexual contact, while in the men, the parenteral route of HIV infection predominated (57.1%) (P=0.0126). Statistically significant differences were found between the rate of single women and men: 21(42%) women versus 2(5.7%) men (P<0.001). An analysis of contraceptive behavior revealed statistically significant differences: 26% of the women and 8.6% of men (P<0.05) did not use any methods of contraception with regular or irregular sexual life. The majority of respondents used a barrier method of contraception and coitus interruptus. The vast majority of women (80%) had a desire to have children in an indefinite future, as opposed to 37.1% of the men (P<0.001). About 11.4% of men and 10% of women (P>0.05) definitely did not plan pregnancy in the future, mainly because of their unsatisfactory financial situation and the presence of a current HIV infection. Forty-two percent of the women did not undergo periodic medical examinations by a gynecologist or other specialists, and 44% of them indicated the reason for the lack of visits to the doctor as an unsatisfactory attitude of medical personnel towards them. The results obtained are important for the development of optimal medical care that alleviates the burden of HIV infection. In addition to medical care, health care providers must consider social and psychological needs to help HIV patients improve their health, including their sexual and reproductive health.

LINC-08. Neuro-Oncology tumor board – one-year experience of international collaboration

BACKGROUND: The management of childhood central nervous system (CNS) tumors is complex and often faces numerous challenges in low- and middle- income countries (LMICs), including delayed diagnosis and limited treatment resources. Twinning initiatives between LMICs with high- income countries are feasible and proven to be highly effective at exchanging skills and expertise to improve diagnosis, treatment and care for children with brain tumors. METHODS: A monthly multidisciplinary international pediatric neuro-oncology tumor board via zoom videoconferencing was established in January 2021. This effort is a collaboration between Washington University School of Medicine, in St. Louis, Missouri, USA and nine international sites. Given the significant contributions of this international effort, it has since grown to include 20 institutions and cancer centers from 12 countries in the Middle East, Europe, Australia and South America. RESULTS: As of January 2022, we have held 11 tumor boards, 35 cases were reviewed, and have had 320 experts attend from several specialties – neuro-oncology, neurology, neurosurgery, neuroradiology and neuropathology. A multidisciplinary team of physicians reviewed each case and recommendations were given accordingly. We also started a quarterly neurofibromatosis (NF) meeting focused to leverage the expertise of dedicated specialists in the NF center. Two NF-focused meetings took place since establishing the program, and total of five cases were discussed. CONCLUSION: Virtual videoconferencing promotes a multi-disciplinary approach for the management of pediatric CNS tumors, and it allows access for medical expertise. We anticipate the current initiative will also provide a platform for future international research collaborations and deliver the optimal medical care for neuro-oncology patients globally. Multiple potential collaborative projects are currently underway.

ADHERENCE TO PHYSICAL ACTIVITY IN OLDER ADULTS WITH HYPERTENSION: LESSONS FROM THE HOLDAGE RANDOMIZED CONTROLLED TRIAL

Objective: Isometric exercise training (IHT) may be a practical, inexpensive and time efficient modality to reduce blood pressure (BP). We report preliminary exercise adherence data from HoldAge (NCT04275037) among older adults with high-normal BP to stage I hypertension. Design and method: Participants performed a total of 24 sessions of IHT or aerobic exercise training (AET), 3 times/week, for 8 wks. IHT was 4x45 min contractions, alternatively with both hands, at an intensity of 50% of the maximum voluntary contraction, with 1 min rest between sets. AET was walking 20–30 min at an intensity of 50–70% of the estimated peak maximal oxygen consumption (VO2peak) assessed with a submaximal step test. The attention control (AC) group received standardized optimal medical care including lifestyle advice. The adherence to IHT was a mean quality score recorded in the digital dynamometer, representing the % time participants performed the exercise sessions at the prescribed intensity. The adherence to AET was the time spent exercising at the prescribed intensity, recorded with a heart rate monitor. Results: 95 eligible people were contacted to participate and 72 agreed to participate (76%). Of these, 49 participants have finished the study (IHT:19; AET:18; AC:12) with 4 dropouts (AET:1; AC:3). Three participants changed their antihypertensive medication and were excluded (AET:1; AC:2). IHT had a self-reported exercise adherence of 96.7 ± 9.3%, while data downloaded from the exercise devices showed an adherence of 88.6 ± 13.9% of the sessions, with 2.3 ± 3.3% incomplete sessions. IHT registered a mean quality score of 91.8 ± 11.2% for the right hand (mean strength: 22.6 ± 7.7 kg), 91.7 ± 13.5% for the left-hand (mean strength: 20.9 ± 8.6 kg), and 91.6 ± 12.2% for both hands. AET had a self-reported exercise adherence of 83.8 ± 33.6%, consistent with the data downloaded from the heart rate monitors. AET participants spent a total of 578.1 ± 263.6 min exercising, of which 153.3 ± 152.4 min (22.6 ± 23.2%) was spent walking at the prescribed intensity, 286.3 ± 210.5 min (45.4 ± 35.2%) was below and 137.8 ± 154.7 minutes (19.4 ± 21.7%) was above. Conclusions: Exercise adherence in HoldAge is high in both IHT and AET, but the time spent at the prescribed intensity appears to be higher in IHT than AET.

EFFECTS OF HOME-BASED ISOMETRIC HANDGRIP OR AEROBIC EXERCISE TRAINING IN OLDER ADULTS WITH PRE-HYPERTENSION AND HYPERTENSION

Objective: Isometric handgrip exercise training (IHT) is a promising non-pharmacological treatment to hypertension. In HoldAge (NCT04275037) we compared the effects of a home-based IHT intervention to home-based aerobic exercise training (AET) intervention or usual care on blood pressure (BP) in older adults with high normal BP and hypertension. Design and method: 53 participants with high normal BP to stage I hypertension were (24 men, age 71.7 ± 4.2 years, systolic BP 138.2 ± 16.2 and diastolic BP 80.4 ± 8.7 mmHg) were randomized into IHT (n = 19), AET (n = 19) or an attention control group (AC, n = 15). Participants performed IHT or AET, 3 times/week, for 8 weeks. IHT consisted of 4x45 sec bilateral contractions, at an intensity of 50% of the maximum voluntary contraction, with a 1-min rest between sets. AET was walking at an intensity of 50–70% of the estimated peak maximal oxygen consumption. The AC group received standardized optimal medical care, including lifestyle advice. Results: Of the 53 participants, 49 finished the intervention (92.5%) with one dropout in AET and 3 in AC. Three participants were excluded due to changes in the antihypertensive medication (AET:1 and AC:2). The self-reported exercise adherence was 96.6% for IHT and 83.8% for AET. There were no significant differences at baseline for SBP (p = 0.343), DBP (p = 0.107) and pulse pressure (PP, p = 0.386). Both exercise interventions elicited similar reductions in SBP from baseline to postintervention (IHT: 138.8 ± 14.9 vs 129.2 ± 10.4 mmHg; p = 0.003; AET: 139.8 ± 19.6 vs 132.6 ± 9.5 mmHg; p = 0.049). There were no changes in BP in the AC group (130.6 ± 12.7 vs 127.9 ± 18.3 mmHg; p = 0.392). DBP decreased after IHT (78.6 ± 7.9 vs 74.7 ± 8.1 mmHg; p = 0.025) but not AET (83.1 ± 9.2 vs 80.8 ± 9.5 mmHg; p = 0.360) or AC (76.5 ± 5 vs 76.5 ± 10.1 mmHg; p = 0.942). Both exercise interventions also elicited similar reductions in PP (IHT: 60.2 ± 10.5 vs 54.4 ± 8.9 mmHg; p = 0.014; AET: 56.7 ± 13.2 vs 51.7 ± 13.5 mmHg; p = 0.016) with no differences for the AC (54.1 ± 10.3 vs 51.2 ± 13.3 mmHg; p = 0.285). Conclusions: The preliminary results from HoldAge indicate home-based IHT and AET elicit significant reductions in office SBP among older adults with high-normal BP to Stage 1 hypertension.

Protocol for the multicentre prospective paediatric craniectomy and cranioplasty registry (pedCCR) under the auspices of the European Society for Paediatric Neurosurgery (ESPN)

PurposeIn the paediatric age group, the overall degree of evidence regarding decompressive craniectomy (DC) and cranioplasty is low, whereas in adults, randomised controlled trials and prospective multicentre registries are available. To improve the evidence-based treatment of children, a consensus was reached to establish a prospective registry under the auspices of the European Society for Pediatric Neurosurgery (ESPN).MethodsThis international multicentre prospective registry is aimed at collecting information on the indication, timing, technique and outcome of DC and cranioplasty in children. The registry will enrol patients ≤ 16 years of age at the time of surgery, irrespective of the underlying medical condition. The study design comprises four obligatory entry points as a core dataset, with an unlimited number of further follow-up entry points to allow documentation until adolescence or adulthood. Study centres should commit to complete data entry and long-term follow-up.ResultsData collection will be performed via a web-based portal (homepage: www.pedccr.com) in a central anonymised database after local ethics board approval. An ESPN steering committee will monitor the project’s progress, coordinate analyses of data and presentation of results at conferences and in publications on behalf of the study group.ConclusionThe registry aims to define predictors for optimal medical care and patient-centred treatment outcomes. The ultimate goal of the registry is to generate results that are so relevant to be directly transferred into clinical practice to enhance treatment protocols.

Sexual Medical Education Challenges During the COVID-19 Pandemic: Strategies for Academic and Community Based Clinicians

Optimal medical care requires a foundation of competent and experienced healthcare professionals in sufficient numbers, armed with expertise across a wide range of therapeutic disciplines, providing timely care to those in need. To achieve these ideal outcomes, adequate infrastructure, resources, and sufficient numbers of well-trained individuals must be available at all times. The impact of the COVID-19 pandemic on sexual medicine education and training has been particularly challenging. The perceived elective nature of the therapeutic area resulted in a relatively greater loss of care and training during the most recent pandemic compared to other therapeutic areas.

Availability of drugs for the treatment of cats with ocular diseases in Germany - Discrepancy between theory and reality

Only a few ophthalmologics specifically approved for cats are available on the market leading to frequent use of drugs approved for humans. In Germany, the administration, dispense or prescription of pharmaceuticals is regulated by the pharmaceuticals law ('Arzneimittelgesetz' (AMG)) as well as the regulation concerning pharmacies in veterinary practice ('Verordnung über tierärztliche Hausapotheken' (TÄHAV)). The aim of this study was to collect data concerning the occurrence and frequency of feline eye diseases and to evaluate the frequency of the necessity for extra-label drug use. Evidence-based, optimal treatment schemes were generated and reviewed with regard to their feasibility in Germany. Data from 876 cats with ocular problems of the "Small Animal Clinic", Freie Universität Berlin as well as a small animal practice in Southern Germany were evaluated (01.01.2015-31.12.2018). Subsequently, the theoretical accessibility for approved agents and/or extra-label drug use in Germany was analyzed. 1198 diagnoses were based on 925 ophthalmic examinations. The most common diseases include conjunctivitis, keratitis, uveitis, hypertensive retinopathy and glaucoma. 885/1198 (73.9 %) of these diseases required treatment, which equates to 722/925 (78.1 %) cases. For all patients, treatment would have been possible according to evidence-based data. In 225/722 (31.2 %) cases, treatment with the pertaining, specifically approved agents would have been possible. Extra-label drug use would have been necessary in 497/722 cases (68.8 %). Of the 497 cases necessitating extra-label use, pharmaceuticals approved for humans would have been available for 481 cases (96.8 %), extra-label use of other veterinary pharmaceuticals would have been possible in 28 cases (5.6 %) and in 60 cases (12.2 %) especially manufactured drugs could have been employed. In a total of 36/722 cases (5 %), optimal care would not have been possible in the context of the current regulatory framework. Based on regulations concerning therapeutic necessity, the ophthalmologic therapy of cats in Germany is possible within the regulatory framework. In the present study, 5 % of the patients could not receive optimal medical care. The closure of this gap demands additional approval of veterinary ophthalmic drugs as well as the research and development of novel active agents and veterinary pharmaceuticals.

Optimal Management of Patients with Severe Coronary Artery Disease following Multidisciplinary Heart Team Approach-Insights from Tertiary Cardiovascular Care Center.

Background: The purpose of this retrospective study was to investigate outcomes of patients with severe coronary artery disease (CAD) after implementing various treatment strategies following multidisciplinary Heart Team (MHT) discussion. Methods Primary and secondary endpoints and quality of life during a mean (SD) follow-up of 37 (14) months of patients with severe CAD (three-vessel [3-VD] or/and left main [LM] disease) qualified after MHT discussion to optimal medical treatment (OMT) alone, OMT and coronary artery bypass grafting (CABG), or OMT and percutaneous coronary intervention (PCI) were evaluated. As the primary endpoint, major adverse cardiac or cerebrovascular events (MACCE) (i.e., death from any cause, stroke, myocardial infarction, or repeat/need for revascularization) were considered. Result: From 2016 to 2019, 176 MHT meetings were held, and a total of 1286 participants with severe CAD and completely implemented MHT decisions (OMT, CABG, or PCI for 251, 356, and 679 patients, respectively) were included. The occurrence of the primary endpoint was significantly increased in OMT-group (154 (61.4%) vs. CABG and PCI groups—110 (30.9%) and 302 (44.5%) patients, respectively (p < 0.05). For interventional strategies only—CABG was associated with reduced rates of MACCE and repeat revascularization, while the superiority of PCI for stroke and disabling stroke was observed (p < 0.05). The general health status assessed at the end of the follow-up was significantly better for patients who underwent CABG or PCI than in the OMT group (p < 0.05). Conclusions: In this real-life study, we presented a single-center experience of providing optimal medical care for patients with severe CAD following MHT discussion.

Care pathways in invasive meningococcal disease: a retrospective analysis of the French national public health insurance database

ABSTRACT Invasive meningococcal disease (IMD) carries a high burden in terms of mortality, long-term complications, and cost, which can be significantly reduced by vaccination. The objectives of this case–control study were to document the care pathways of patients with IMD before, during, and after hospitalization and to assess in-hospital complications and long-term sequelae. Cases consisted of all people hospitalized for IMD in France between 2012 and 2017. Controls were matched by age, gender, and district of residence. Data were extracted from the French national public health insurance database on demographics, hospitalizations, mortality and potential sequelae of IMD. Overall, 3,532 cases and 10,590 controls were assessed and followed up for 2.8 years (median). During hospitalization, 1,577 cases (44.6%) stayed in an intensive care unit, 1,238 (35.1%) required mechanical ventilation, and 43 (1.2%) underwent amputation; 293 cases (8.3%) died in hospital and a further 163 (4.6%) died following discharge; 823 cases (25.4% of survivors) presented ≥1 sequela and 298 (9.2%) presented multiple sequelae. The most frequently documented sequelae were epilepsy (N = 205; 5.8%), anxiety (N = 196; 5.5%), and severe neurological disorders (N = 193; 5.5%). All individual sequelae were significantly more frequent (p < .0001) in cases than controls. Hearing/visual impairment and communication problems were conditions that presented the highest risk for cases compared to controls (risk ratios >20 in all cases). In conclusion, this study highlights the importance of providing optimal medical care for patients with IMD, of minimizing the delay before hospitalization, and of effective prevention through comprehensive vaccination programs.

Primary PCI in Patients Admitted with Cardiogenic Shock and STEMI: Outcome and Predictors of In-hospital Mortality

<i>Background</i>: It is a well-known phenomenon that cardiogenic shock (CS) is a serious complication of acute myocardial infarction. The mortality rate is approximately 50% even with rapid revascularization, optimal medical care, and use of mechanical support. <i>Aim of the Work</i>: To investigate the outcome of primary percutaneous coronary intervention (PCI) in patients admitted with cardiogenic shock and ST-segment elevation myocardial infarction (STEMI) and the predictors of in-hospital mortality. <i>Patients and Methods</i>: This prospective, observational study was conducted in the national heart Institute, Alazhar University, and Military hospitals in the period from 6/2019 to 9/2021 on fifty six consecutive patients presenting to Alazhar University hospitals, National Heart Institute (NHI), Military hospitals. <i>Results</i>: The prevalence of dyslipidemia and diabetes mellitus were significantly higher among died patients than those who survived. The degree of LV impairment was significantly higher among patients who died than those who survived. As regard to PCI procedure characteristics, TIMI flow post PCI (<Grade III), multi-vessel disease, and procedural failure were significantly associated with high in-hospital mortality rate. Patients who received treatment with IABP were significantly older. <i>Conclusion</i>: Multi-vessel coronary artery disease, TIMI flow after PCI (grade III), and ↑ CK-MB (72-hour serial measurement), were all found to be significant predictors of in-hospital mortality. The onset from chest pain to ED arrival and the door-to-balloon time were higher than that reported in the previous studies. The use of IABP was not found to have a significant predictor effect on the different outcome among our patients with STEMI.

Emergency Cesarean Section in a COVID-19 Patient with Antepartum Hemorrhage: A Case Report

Introduction: Perioperative management of patients with corona virus disease 2019 (COVID-19) could be extremely challenging in order to keep the balance between providing optimal medical care and protecting health-care providers from the risk of infection. Also the respiratory effect of COVID 19 could also alter the course and outcome of surgery. Aim: We aim to report a 30-year-old COVID-19 patient who had emergency cesarean section on account of placenta praevia. Methodology: The cesarean section was done under subarachnoid block while there was no significant event perioperatively while preventive measures were taken to avoid cross infection with the managing team. Results: The patient had a safe anesthesia and surgery. Polymerase Chain Reaction (PCR) test was done fourth day after surgery was negative for the mother and child.

Perioperative management of the brain-dead organ donor : Anesthesia between ethics and evidence

HintergrundDie Anzahl postmortal gespendeter Organe ist in Deutschland weit geringer als der Bedarf. Dies unterstreicht die Wichtigkeit einer optimalen Versorgung während des gesamten Prozesses der Organspende.FragestellungEs existieren internationale Leitlinien und nationale Empfehlungen zu intensivmedizinischen organprotektiven Maßnahmen beim Organspender. Für das anästhesiologische Management fehlen evidenzbasierte Empfehlungen. Ziel dieser Übersichtsarbeit ist es, anhand der vorhandenen Evidenz die pathophysiologischen Veränderungen des irreversiblen Hirnfunktionsausfalls zu rekapitulieren und sich kritisch mit den empfohlenen Behandlungsstrategien und therapeutischen Zielgrößen auseinanderzusetzen. Auch auf ethische Aspekte der Betreuung des postmortalen Organspenders wird eingegangen.MethodeDiese Übersichtsarbeit basiert auf einer selektiven Literaturrecherche in PubMed (Suchwörter: „brain dead donor“, „organ procurement“, „organ protective therapy“, „donor preconditioning“, „perioperative donor management“, „ethical considerations of brain dead donor“). Internationale Leitlinien und nationale Empfehlungen wurden besonders berücksichtigt.ErgebnisseInsgesamt ist die Evidenz für optimale intensivmedizinische und perioperative organprotektive Maßnahmen beim postmortalen Organspender sehr gering. Nationale und internationale Empfehlungen zu Zielwerten und medikamentösen Behandlungsstrategien unterscheiden sich teilweise erheblich: kontrollierte randomisierte Studien fehlen. Der Stellenwert einer Narkose zur Explantation bleibt sowohl unter pathophysiologischen Gesichtspunkten als auch aus ethischer Sicht ungeklärt.SchlussfolgerungenDie Kenntnisse über die pathophysiologischen Prozesse im Rahmen des irreversiblen Hirnfunktionsausfalls und die organprotektiven Maßnahmen sind ebenso Grundvoraussetzung wie die ethische Auseinandersetzung mit dem Thema postmortale Organspende. Nur dann kann das Behandlungsteam in dieser herausfordernden Situation sowohl dem Organempfänger als auch dem Organspender und seinen Angehörigen gerecht werden.

The Impact of Radiation Therapy on Obstetric Complications in Cancer Survivors

<h3>Purpose/Objective(s)</h3> Long-term side effects of radiation therapy (RT) include fibrosis, poor wound healing and hormonal dysfunction. These may potentially deleteriously affect obstetric outcomes amongst female cancer survivors, but there is minimal data. We hypothesized that previous RT treatment would be associated with increased maternal and fetal complications. <h3>Materials/Methods</h3> We utilized the Nationwide Inpatient Sample (NIS) Healthcare Cost and Utilization Project, containing discharge data from 1,050 hospitals in 44 states, a 20% stratified sample of hospitals in the US. Inclusion criteria were women with a previously specified cancer diagnosis, now hospitalized for a birth between 2015 and 2017; there were no exclusion criteria. The incidence of maternal (i.e., organ failure, infections, transfusions) and obstetric (including eclampsia, abruption, fetal distress) complications was compared between those who had / had not previously received RT. Categorical variables were compared using chi-square test. In addition, composite endpoints of ‘any maternal complication' and ‘any fetal complication' were analyzed, with predictors assessed using logistic regression. <h3>Results</h3> A total of 3215 patient hospitalizations were included in the study, of whom in 135 the mother had previous received RT. Median age – 31 years, 69% white, no sig. difference between those who did / did not receive RT. Cancer type was unevenly distributed between the two groups – RT patients had mostly lymphoma (36%), thyroid (25%) and breast (23%) cancer, whereas non-RT patients had thyroid (26%), melanoma (19%), breast (11%) and cervix (10%). Background maternal medical conditions: heart disease (OR 23.1, <i>P</i> < 0.001) and thyroid disease (OR 1.6, <i>P</i> < 0.04) were more common amongst those who had received RT. Regarding maternal medical complications, respiratory failure (OR 6.6, <i>P</i> < 0.01), and mechanical ventilation (OR 11.5, <i>P</i> = 0.01) were all more common in the ‘received-RT' group. Regarding obstetric complication, none were associated with previous RT (of note, there were fewer cesarean sections in the previous RT group). On multivariate analysis for the composite endpoint ‘obstetric complications' age (HR 1.02, <i>P</i> < 0.001), exposure to chemotherapy (HR 1.47, <i>P</i> = 0.01) and diabetes mellitus (HR 1.99, <i>P</i> = 0.06, borderline) were associated with poorer outcomes; there was no association with previous RT. On multivariate analysis for composite endpoint ‘maternal complications', no single covariate was associated with a worse outcome. <h3>Conclusion</h3> Previously RT was associated with an increased risk of maternal respiratory medical complications at time of delivery. Conversely and reassuringly, previous RT was not associated with increased fetal complications at delivery. Out data legitimize current trends to minimize cardiac radiation exposure in young women, and provide guidance for the optimal medical care of cancer survivors at time of delivery.

Nationwide Survey of German Outpatient Gynecologic Oncology Practices during the Coronavirus Disease 2019 Pandemic: Reactions to the First Wave and Future Perspectives

Introduction: In the spring of 2020, coronavirus disease 2019 posed a substantial challenge for countries and their healthcare systems. In Germany, over 70% of all cancer patients are treated in an outpatient setting, so gynecologic oncology practices are the guarantors of optimal patient care. We developed a survey to evaluate the management of gynecologic oncology patients. Methods: The survey consisted of 38 questions and was sent to the members of the Berufsverband Niedergelassener Gynäkologischer Onkologen in Deutschland e.V. (BNGO), a professional association of gynecologic oncologists in the outpatient sector in Germany. Results: The survey was completed by 54 out of 133 (41%) gynecologic oncologists from 14 out of 15 (93%) federal states where the BNGO is represented. Facing the pandemic, popular measures were mask requirements (100%), restriction of access to practices (94%), increased number of disinfectant dispensers (85%), installment of panes of acrylic glass (76%), or spatial alterations (67%). For most patients the pandemic had no influence on prioritization of therapies (82%) or prescribed systemic treatments (87%). Despite an increase in perceived psychological burden among the staff (72%), 85% (45/54) of the practices were not offered any additional psychological support. Discussion and Conclusion: As most cancer patients in Germany are treated in an outpatient setting, a suitable reaction of oncology centers to the new circumstances was crucial to secure optimal treatment and patient care. Nevertheless, the low prioritization of mental health or distress of healthcare workers poses a serious threat to the maintenance of optimal medical care in further waves of the pandemic.

Medical Affairs in Pharmaceutical Companies and Related Pharmaceutical Regulations in Japan.

Medical affairs has received a lot of attention in recent years in Japan, but it is also often misunderstood or poorly understood in the healthcare industry in Japan. In the United States, the function of medical affairs has been established for a long time, whereas its history in Japan is relatively short. Many scandals in clinical trials occurred with inappropriate relationship between medical doctors and the sales departments of pharmaceutical companies from 2012. These incidents undermined confidence in clinical trials in Japan and triggered the enforced separation of sales departments from the conduct of post-marketing clinical trials and evidence generation. There have been growing compliance issues identified in marketing and sales practices, and off-label promotion is also becoming an issue in Japan. These issues resulted in the establishment of independent medical affairs departments from sales departments in pharmaceutical companies operating in Japan. Due to the short history of medical affairs in Japan, the roles and responsibilities vary between companies in Japan. Medical affairs departments aim to fulfill unmet medical needs through the generation of scientific evidence and to deliver scientific value to key stakeholders and patients. People working in medical affairs need to engage in scientific exchange activities with key opinion leaders independent of sales departments. Through these activities, medical affairs ensures that patients receive optimal medical care. Medical affairs in Japan is still developing, and its roles, responsibilities, and functions are improving. This article covers the history of medical affairs in Japan and the current status and future perspectives of medical affairs in Japan.

Selected Issues in Sport-Related Concussion (SRC | Mild Traumatic Brain Injury) for the Team Physician: A Consensus Statement.

Selected Issues in Sport-Related Concussion (SRC | Mild Traumatic Brain Injury) for the Team Physician: A Consensus Statement is title 22 in a series of annual consensus articles written for the practicing team physician. This document provides an overview of select medical issues important to team physicians who are responsible for athletes with sports-related concussion (SRC). This statement was developed by the Team Physician Consensus Conference (TPCC), an annual project-based alliance of six major professional associations. The goal of this TPCC statement is to assist the team physician in providing optimal medical care for the athlete with SRC.

Assessment of right ventricular remodeling and dysfunction in obstructive sleep apnea syndrome: a prospective monocentric study.

Obstructive sleep apnea (OSA) is a common sleep-related disorder that has been implicated in many serious cardiovascular diseases including cardiac remodeling and dysfunction. Since most investigations have focused on the left heart, little is known on right ventricular (RV) involvement in OSA. The role of theRV in the management of cardiovascular outcomes has become increasingly recognized. Early detection of subtle signs of RV dysfunction and remodeling in patients withOSA is crucial for optimal medical care. We aimed to investigate the effect of OSA and its severity on the RV structure and function using conventional echocardiography. We conducted a cross-sectional analytical study including patients withOSA who did not have heart failure or chronic pulmonary disease comparing them to controlswithout OSA. All patients underwent respiratory polygraphy at the Pneumology Department and standard echocardiography performed by the same blinded cardiologist at the Cardiology Department of Taher Sfar University Hospital. A total of 139 patients withOSA and 45 controls were enrolled in the study. Amonth the patients, there were 32% (n = 44) withmild, 20% (n = 28) withmoderate, and 48% (n = 67) withsevere OSA. Sixty-three percent of the study population were women. The mean age was 54.1 ± 11.0years. Early RV dilatation was present in the mild disease stage (RVID = 42.0 ± 7.7mm vs. 32.4 ± 5.5mm in controls; p < 0.0001) without obvious RVH. The systolic pulmonary artery pressure was significantly higher in patients withOSA (31.2 ± 8.2 vs. 20.9 ± 9.8; p < 0.0001). Tricuspid annular plane systolic excursion was borderline normal and significantly lower in patients withOSA (17.7 ± 4.7 vs. 26.0 ± 5.7, p < 0.0001). In multivariate analysis, an OSA was independently associated with RV remodeling (OR: 0.257, 95% CI [0.114-0.582], p = 0.001) but not with RV dysfunction. OSA was independently associated with structural alterations of RV early in the disease course, suggesting that the reversibility of these deleterious effects requires earlier detection and initiation of treatment.

Adverse Effects Associated With the Use of Antimalarials During The COVID-19 Pandemic in a Tertiary Care Center in Mexico City.

Background: Antimalarial drugs were widely used as experimental therapies against COVID-19 in the initial stages of the pandemic. Despite multiple randomized controlled trials demonstrating unfavorable outcomes in both efficacy and adverse effects, antimalarial drugs are still prescribed in developing countries, especially in those experiencing recurrent COVID-19 crises (India and Brazil). Therefore, real-life experience and pharmacovigilance studies describing the use and side effects of antimalarials for COVID-19 in developing countries are still relevant. Objective: To describe the adverse effects associated with the use of antimalarial drugs in hospitalized patients with COVID-19 pneumonia at a reference center in Mexico City. Methods: We integrated a retrospective cohort with all adult patients hospitalized for COVID-19 pneumonia from March 13th, 2020, to May 17th, 2020. We compared the baseline characteristics (demographic and clinical) and the adverse effects between the groups of patients treated with and without antimalarial drugs. The mortality analysis was performed in 491 patients who received optimal care and were not transferred to other institutions (210 from the antimalarial group and 281 from the other group). Results: We included 626 patients from whom 38% (n = 235) received an antimalarial drug. The mean age was 51.2 ± 13.6 years, and 64% were males. At baseline, compared with the group treated with antimalarials, the group that did not receive antimalarials had more dyspnea (82 vs. 73%, p = 0.017) and cyanosis (5.3 vs. 0.9%, p = 0.009), higher respiratory rate (median of 28 vs. 24 bpm, p < 0.001), and lower oxygen saturation (median of 83 vs. 87%, p < 0.001). In the group treated with antimalarials, 120 patients had two EKG evaluations, from whom 12% (n = 16) prolonged their QTc from baseline in more than 50 ms, and six developed a ventricular arrhythmia. Regarding the trajectories of the liver function tests over time, no significant differences were found for the change in the mean value per day between the two groups. Among patients who received optimal care, the mortality was 16% (33/210) in those treated with antimalarials and 15% (41/281) in those not receiving antimalarials (RR 1.08, 95% 0.75–1.64, and adjusted RR 1.12, 95% CI 0.69–1.82). Conclusion: The adverse events in patients with COVID-19 treated with antimalarials were similar to those who did not receive antimalarials at institutions with rigorous pharmacological surveillance. However, they do not improve survival in patients who receive optimal medical care.

Long Term Survival and Limb Salvage in Patients With Non-Revascularisable Chronic Limb Threatening Ischaemia

The aim of this study was to provide long term survival and limb salvage rates for patients with non-revascularisable (NR) chronic limb threatening ischaemia (CLTI). This was a retrospective review of prospectively collected data, derived from a randomised controlled trial (JUVENTAS) investigating the use of a regenerative cell therapy. Survival and limb salvage of the index limb in CLTI patients without viable options for revascularisation at inclusion were analysed retrospectively. The primary outcome was amputation free survival, a composite of survival and limb salvage, at five years after inclusion in the original trial. In 150 patients with NR-CLTI, amputation free survival was 43% five years after inclusion. This outcome was driven by an equal rate of all cause mortality (35%) and amputation (33%). Amputation occurred predominantly in the first year. Furthermore, 33% of those with amputation subsequently died within the investigated period, with a median interval of 291 days. Five years after the initial need for revascularisation, about half of the CLTI patients who were deemed non-revascularisable survived with salvage of the index limb. Although the prospects for these high risk patients are still poor, under optimal medical care, amputation free survival seems comparable with that of revascularisable CLTI patients, while the major amputation rate within one year, especially among NR-CLTI patients with ischaemic tissue loss, is very high.