EMA's COOKE REVIEWS EUROPEAN CANCER PROSPECTS

Late January saw Emer Cooke, the new executive director of the European Medicines Agency, fresh from a tough debate on vaccines in the European Parliament's health committee, switch her attention to cancer, with an appearance at another of the parliament's specialized committees. [...]she had some clear ideas on how this should be done, with a powerful emphasis on patient benefit as a priority. "To do this we need to leverage the resources for conducting high quality research in Europe." Better communication could also decrease time lags and differences of view between approval decisions by regulators and access decisions by health technology assessment bodies.

SAFETY ANALYSIS OF JAKINIBS IN REAL CLINICAL PRACTICE IN A COHORT OF 116 PATIENTS

BackgroundJanus kinase inhibitors (JAKinibs) have demonstrated efficacy in the treatment of rheumatoid arthritis (RA) and spondyloarthritis (SpA), although their safety profile continues to be analysed due to the possible increase in adverse events (AEs) in relation to anti-TNFs (mild and severe infections, haematological alterations, thromboembolism, increase in neoplasms).ObjectivesTo evaluate in real clinical practice the AEs of JAKinibs in a cohort of patients with RA and SpA. In addition, adherence and reasons for discontinuation (1st or 2nd failure, AE) are analysed.MethodsObservational study of 116 patients diagnosed with RA or SpA who received treatment with JAKinibis (tofacitinib, baricitinib, upadacitinib) after failure of treatment with different classical synthetic (FAMEsc) or biological (FAMEb) disease-modifying drugs. The following data were analysed: demographic characteristics of the patients, years of disease progression, 1st or 2nd failures and AE.ResultsMean age was 52 years, with Baricitinib being older (60 years -SD 13.6), higher prevalence of females in all groups, and a disease progression time of about 10 years. Mean number of FAMEsc was 1.6 and mean number of FAMEb was 2,3 to Tofacitinib(Tofa), 2,76 to Baricitinib(Bari) and 4,4 to Upadacitinib(Upa). 71 (63%) patients had active corticosteroid therapy. The median treatment time with Tofa was 8.8 months, Bari 9.5 and Upa 2.4 months.Most frequent AEs with Tofa were urinary tract infections(UTI) (11.9%, 7 cases) and headaches (8.47%, 5 cases). There were 3 cases of herpes zoster (5.1%), one of which was recurrent, and 2 cases respectively of tachycardia and gastrointestinal intolerance (3.4%). With Baricitnib, 2(5%) cases of UTI and 2(5%) of influenza A were reported. Most frequent AEs related to Upadacitinb are gastrointestinal intolerance, labialis and facial herpes, anterior uveitis and recurrent UTI, with 1 case for each adverse event. There were 4 success with Baricitinib treatment: 2 due to severe COVID, 1 influenza A and 1 due to stroke. 17 patients had 1st failure to Tofa(28.81%), 8 to Bari20.0%) and 3 to Upa(18.75%);7(11.86%) and 2(5%) patients had 2nd failure to Tofa and Bari respectively, no with Upa.Mean CRP to Tofa-SD 18.9-was 17.19, 20-SD 22.7- to Bari and 24.2-SD 27.40- to Upa. Mean ESR-SD 15.3- was 25.4, -SD 26.4 and 44.3 -SD 32-, respectively. At 6 months, 36(62%) were continuing on Tofa, 22(56%) on Bari and 4(27%) on Upa. At 12 months, 27(46.6%) were still on Tofa and 12 on Bari(30.8%) and no patients were on upa.Table 1.TofaBariUpaMean age496047Male19%18%20%Female81%82%80%Time course of disease(years)81111Permanence 6 months62%56%27%Permanence 12 months46,6%31%0%Patients with corticotherapy62%64%60%Previous biological drugs2,3 SD 22,8 SD 2,34,4 SD 2,9Patients who discontinued the drug62%59%33%Mean CRP at the end of treatment172024Mean end-of-treatment ESR252644Repeated AEsUTI(7) Headache(5) Shingles(3) Nephritic colic(2) Gastrointestinal intolerance(2) Tachycardia(2)UTI(4) Headache(2)Serious AEsShingles (3)Varicella encephalopathy(1) Stroke(1) Shingles (1)1st failure28,8%20%18,7%2nd failure11,9%5%0%SuccessSARS-Cov2(2) Influenza(1) Stroke(1)Figure 1. Months stay pharmacoConclusionMost frequent adverse events with JAKinibs are mild infections, except gastrointestinal complaints with upadacitinib. Serious adverse events, including 3 deaths from viral infections, were observed, mostly in patients over 65 years. Most frequent cause of discontinuation was treatment failure. We believe that further observational studies are needed to stratify and profile the risk of infection with JAKinibs.References[1]Atzeni F, Popa CD, et al. Safety of JAK inhibitors: focus on cardiovascular and thromboembolic events. Expert Rev Clin Immunol. 2022 Mar;18(3):233-244. Doi: 10.1080/1744666X.2022.2039630 Epub 2022 Feb 17.PMID: 35129033[2]Alves C, Penedones A,et al. The Risk of Infections Associated With JAK Inhibitors in Rheumatoid Arthritis: A Systematic Review and Network Meta-analysis. J Clin Rheumatol. 2022 Mar 1;28(2):e407-e414 PMID:33902098Ackn wledgements:NIL.Disclosure of InterestsNone Declared.

VACCINATION RATE, ADVERSE REACTIONS, AND REASONS FOR NONVACCINATION OF COVID-19 VACCINE IN PATIENTS WITH RHEUMATOID ARTHRITIS IN A JAPANESE REAL-WORLD CLINICAL PRACTICE

BackgroundThe first coronavirus infection was confirmed in Wuhan City, People's Republic of China, in December 2019. On January 30, 2020, the World Health Organization declared the novel coronavirus disease a public health emergency of international concern. On March 11, 2020, World Health Organization announced that the new coronavirus infection can be regarded as a pandemic because of the global spread of the infection. The world's first authorization for a coronavirus disease 2019 vaccine (CV) in the UK was in December 2020. The first authorization for a CV in Japan was in February 2021. A maximum of five times of vaccination had been performed in Japanese people until January 2023. Patients with rheumatoid arthritis (RA) are generally immunocompromised because of the drugs used for RA treatment. Patients with RA are recommended to receive a CV in the 2021 update of the EULAR recommendations for the management of rheumatic and musculoskeletal diseases in the context of SARS-CoV-2 [1]. However, some patients with RA rejected CV for various reasons or reports of adverse reactions (ARs) in clinical practice. Real-world clinical information on CV is necessary for better relationships between patients with RA and their physicians.ObjectivesThis retrospective study aimed to determine the vaccination rate, ARs, and reasons for nonvaccination of CV in patients with RA in clinical practice.MethodsThe vaccination rate, ARs, and reasons for nonvaccination of CV in patients with RA on clinical records of our institute were investigated up to the third vaccination. Patients were divided into three age groups: 0–64 years old (YG), 65–74 years old (OG), and >75 years old (VOG). The association between age groups and vaccination rates was also investigated. The Cochran–Armitage test was used for statistical analysis.ResultsRegarding patient background (n = 610), the mean age was 67.8 years (YG, n = 207;OG, n = 196;VOG, n = 207;female, 75.1%;mean RA duration, 14.1 years). The vaccination rate among all patients was 8.4% for nonvaccination;91.6% for the first dose;91.3%, second dose;and 86.6%, third dose. A significant decrease over time was observed (p < 0.01). Nonvaccination was observed in 13.0%, 9.2%, and 2.9% of those in YG, OG, and VOG, respectively. A higher rate of nonvaccination was observed in the YG (p < 0.01). The results of the analysis by age group were 87.0%/90.8%/97.1% (first dose), 87.0%/90.3%/96.6% (second dose), and 77.8%/86.7%/95.2% (third dose) among the YG/OG/VOG, respectively (Figure 1). No statistically significant decrease in the vaccination rate was found over time in OG (p = 0.19) and VOG (p = 0.30) but not in VOG (p = 0.01). ARs occurred in 8.2%, 14.5%, and 16.1% of the patients receiving the first, second, and third doses, respectively. Among the reasons for nonvaccination, 35 (68.6%) patients were concerned about ARs to CV and 6 (11.8%) thought that CV was unnecessary.ConclusionCV rate in our cohort was higher than that of whole nation in Japan (81.4% for the first dose, 80.4% for the second dose, 67.8% for the third dose). CV rate has been declining steadily in patients with RA, with a stronger trend in younger age groups. Fear of ARs was the most frequent reason for nonvaccination.Reference[1]Landewé RBM et al. Ann Rheum Dis 2022.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

SWITCHING FROM IL-6R ANTAGONISTS TO OLOKIZUMAB, A DIRECT IL-6 INHIBITOR

BackgroundOlokizumab (OKZ), an IL-6 ligand inhibitor in doses of 64 mg every two weeks (q2w) or every 4 weeks (q4w) demonstrated significant improvements in signs and symptoms of RA. Due to lack of availability of the IL-6 receptor antagonists tocilizumab and sarilumab in the pandemic COVID-19 situation, RA patients (pts) were switched to OKZ as a registered drug in Russia in 2022.ObjectivesTo investigate safety and efficacy of OKZ after switching from an IL-6 receptor inhibitor in clinical practice.MethodsThis retrospective cohort study included available efficacy and safety data of OKZ in pts with RA after switching from tocilizumab (IV or SC) or sarilumab (SC) from 11 of participating centers.Efficacy assessments and routine biochemical data were analyzed using descriptive statistics – mean with standard deviation for continuous parameters and absolute and relative frequency for binary variables. AE were reported by participating centers according to pt's files. The statistical significance of data of the analyzed variable at a particular visit compared with previous visits or with the Switch visit was determined using paired t-test. Fisher's exact test or chi-square test was used to compare the proportion of pts with improvement/no change and worsening. All tests were 2-tailed, and a p-value <0.050 was considered statistically significant. As this is an observational study, the statistical criteria have not been pre-specified and therefore the data presented cannot be considered definitive but should be confirmed in future analyses.ResultsEfficacy and safety results were collected for 110 RA pts with a mean age of 47.8 (15.7) years, including 87 (79.1%) women. 77 (70.0%) pts were RF/ACPA positive. Mean RA duration was 13.1 (8.9) years and mean duration of treatment with an IL-6 receptor antagonist was 47.8 (30.0) months. Mean interval before switching was 54.7 (35.4) days with the main reason of unavailable IL6-R antagonist. Pts were treated with OKZ 64 mg q4w SC.Before initiation of OKZ, an increase of DAS28-CRP was observed due to a prolonged period after the last injection of the IL-6R inhibitor from 2.8 to 3.1 weeks in 32 pts on monotherapy who were transferred to OKZ faster (on average after 41.6 (23.8) days), and from 2.7 to 3.3 weeks in 73 pts on concomitant sDMARDs (60.0 (38.0) days). DAS28-CRP was improved to 2.8 on the second OKZ visit (S+1) in both groups. Response to OKZ was maintained over a period of 2 months with no difference between pts previously receiving an IL-6 R antagonist. Of note, lower disease activity based on DAS28-CRP of 2.5 and 2.6 was achieved after 8 weeks (S+2) of OKZ therapy compared to the previous IL-6R inhibitors treatment S-1 visit (P less 0.05) (Figure 1).Figure 1.Mean DAS28CRP over time, M(SD)[Figure omitted. See PDF]Abbreviation: S-2 and S-1 last visits before switching– S+1 and S+2 visits after switching,Treatment emergent AE occurred in 7 (6.4%) pts, the most common AE in 3 pts (2.7%) included arthralgia of hands and feet and transient leukopenia in 2 (1.8%) pts.Serious AE were reported by 1 (0.9%) pt (exacerbation of herpes infection that led to treatment discontinuation). No deaths were reported. There were no apparent differences in safety and efficacy outcomes between pts on OKZ monotherapy compared to combined treatment with csDMARDs. Only one pt was switched back to tocilizumab when it became available.Table 1.Summary of treatment emergent adverse events (safety population)NOKZ 64 mg q4w with MTX N=78OKZ 64 mg q4w monotherapy N=32Any AE51 carpal canal syndromeAny serious AE10Any AE leading to discontinuation of study drug10Any death00Any AE of special interest10Infections10Laboratory abnormalitiesHyperbilirubin-emiaALT, AST elevation less than 3 ULNALT, alanine transaminase;AST, aspartate transaminase;ULN, upper limit of normalConclusionIn pts with RA responding to an IL-6R antagonist, switching to OKZ was safe and well tolerated in clinical practice. The treatment response was maintained and in some pts disease activity moderately decreased in compariso to baseline level both in OKZ mono and combination therapy.Reference[1]J.Smolen, N Engl J Med 2022;387:715-726AcknowledgementsI have acknowledgements to Vinogradova I.B., Anoshenkova O.N., Antipova O.V., Baranov A.A., Bogdanova E.A., Grabovetskaya Y.Y., Ilivanova E.P.,Kalyagin A.N., Kushnir I.N., Lapkina N.A. Mokrousova M.V., Nesmeyanova O.B., Nikitina N.V., Shesternya P.A. and Yudina N.V.Disclosure of InterestsEugen Feist Consultant of: Abbvie, Eli Lilly, Galapagos, Medac, Novartis, Sanofi, Sobi, R-Pharm, Grant/research support from: Eli Lilly, Novartis, Pfizer, Evgeny Nasonov Consultant of: AbbVie, Eli Lilly, Janssen, Novartis, Pfizer.

Managing Risks in Clinical Trials During a Pandemic with ICH E6 (R2)

Consisting of a variety of required components-including but not limited to quality risk assessments, a written Quality Risk Management Plan, and strategic, centralized data reviews-the revision underscores the importance of a robust RBQM framework to ensure clinical trial execution in compliance with GCP. In this article, we will examine the overall value of ICH E6 (R2) to sponsors, as well as how COVID-19 has and will continue to influence sponsors' consideration of risk-based monitoring as a key component of clinical trial operations. [...]if they have not proactively identified key data and processes that could bring potential risk, they run the danger of getting "lost in the weeds" and overlooking risk factors that later breached tolerance limits and resulted in issues that had some level of impact on the study and its results. At Rho, we consider a robust RBQM framework to include dedicated quality risk managers, RBQM templates to assist with creating the plans required by ICH E6 (R2), a strategic approach to data review, among other components.

TESTING A NEW FATIGUE CHECKLIST IN SLE PATIENTS FOR EVERYDAY CLINICAL PRACTICE - AN INTERIM ANALYSIS

BackgroundFatigue is a difficult subject for both physicians and patients. It is barely addressed during consultations and can therefore burden patient-physician-relations. To improve communication regarding fatigue, we developed a checklist that includes suggestions for evaluating possible causes for fatigue. In this analysis, we describe our study population and report first results 3 and 6 months after using the checklist.ObjectivesThe aims of our study are to validate the use of our newly developed fatigue checklist and to demonstrate that addressing fatigue in daily clinical practice and offering possible interventions can improve fatigue.MethodsWe recruited n=110 SLE patients with fatigue from our university hospital-based lupus reference centre in Duesseldorf. Fatigue was measured using the FSS (Fatigue Severity Scale). Our checklist included signs of depression and anxiety using the PHQ-4 (Patient Health Questionnaire), BMI (body mass index), physical activity, anemia, hypothyroidism and vitamin D deficiency. For each applicable cause, we listed possible interventions for free selection by the treating physician, such as replacement therapy (vitamin D, vitamin B12, iron, folic acid, erythropoietin), physical activity programs and psychosomatic consultations that were discussed with the patients. We re-evaluated our patients after 3 (T1) and 6 months (T2).ResultsBaseline characteristics of patients are summarized in Table 1.Table 1.BMI=body mass index, TSH=thyroidea stimulating hormone, PHQ4=patient health questionnaire (cut-off >3 points), HAQ=health assessment questionnaire, IMET= Index for measuring restrictions on social participation (higher scores point towards more restrictions on social participation), FSS=fatigue severity scale (≥4 points equal severe fatigue)N = 110n (%)Mean (SD)Age (years)49.0 (12.34)Female sex99.0 (90.0)BMI (kg/m2)25.9 (5.55)Disease duration (years)19.1 (10.05)TSH (µIU/ml)1.5 (1.05)25-OH-Vitamin D (ng/ml)39.5 (15.35)Haemoglobin (g/dl)13.0 (1.64)Sports activities>4h/week6.0 (5.5)2-4h/week18.0 (16.4)1-2h/week16.0 (14.5)<1h/week28.0 (25.5)No sport42.0 (38.2)Depression (PHQ4 score)2.3 (1.63)Anxiety (PHQ4 score)2.0 (1.71)Functional status (HAQ score)0.8 (0.49)Participation (IMET score)2.8 (2.31)Fatigue (FSS score)5.3 (1.35)After 3 and 6 months, we re-evaluated 83 patients and saw a significant reduction in fatigue measured by the FSS score (T1: mean difference estimate 0.367 and p-value <0.001;T2: mean difference estimate 0.305;p-value <0.005).Figure 1.Comparing FSS-Scores from T0, T1 and T2[Figure omitted. See PDF]ConclusionThe preliminary analysis of our study shows for the first time that incorporation of a checklist procedure into the management of patients with fatigue may improve short-term outcome after 3 and 6 months of observation. The improvement of symptoms documented in our study occurred even though the suggested exercise program and psychosomatic counseling sessions were not available for use during the current observation period because of the COVID-19 pandemic. At present, the mechanisms behind the observed effect remain unclear. Our ongoing analysis will clarify whether an additional effect on fatigue will occur after all suggested interventions resulting from the use of the checklist have been executed. Finally, it will demonstrate whether the incorporation of our checklist into routine clinical practice is capable to reduce fatigue over a prolonged time period.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

Patients' Experience of Mental Health Services with Telepsychiatry in Qatar

Telepsychiatry has been established for many years with evidence of efficacy as well as challenges. In the Middle East, it remains underutilized. This is despite the high stigma associated with mental illness being a major barrier to access to specialized mental health care. With the onset of the COVID-19 pandemic, there was a worldwide urgent need to establish services that provided the care needed without direct contact. Qatar, like other countries in the region, had to provide telemedicine, including telepsychiatry, within a very short period to address the growing demand for mental health during a time when face-to-face clinical care was minimized. In this brief communication, we describe the experience in Qatar, and the outcome of a survey of strengths and challenges reported by service users. [ FROM AUTHOR] Copyright of Arab Journal of Psychiatry is the property of Arab Federation of Psychiatrists and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Health is complex, the solutions are long term

The debate on folic acid fortification of food to prevent neural tube defects in babies, for example, hasn't progressed in more than two decades (doi:10.1136/bmj.p1158).8 The worrying rise in perinatal suicides requires better funded services and support for women and young families to prevent deaths (doi:10.1136/bmj-2023-075414).9 And are the mandatory school inspections that harm the mental health of teaching staff even necessary (doi:10.1136/bmj.p1147)?10 The same applies to overzealous and discriminatory processes implemented by medical regulatory bodies such as the General Medical Council, despite claims of improvement by its chief executive (doi:10.1136/bmj.p1295 doi:10.1136/bmj.p1252).1112 The prevention principle would urge us to support a ban on vaping (doi:10.1136/bmj.p1266) and consider new options for reducing the number of days people experience migraines (doi:10.1136/bmj.p1249).1314 It would also induce bewilderment at the decision to wind down the UK's world leading covid surveillance network when covid-19 is still with us and future pandemics are inevitable (doi:10.1136/bmj.p1157).15 It would not, however, lend support to a non-evidence based screening programme for haemochromatosis (doi:10.1136/bmj.p1264).16 The first steps of an "avoid, reduce, reuse, recycle, research, rethink” framework (doi:10.1136/bmj-2021-069044) focus on better clinical practice that avoids low value care and inappropriate admissions and minimises blood tests and other interventions.17 This latest article in our series on achieving net zero and environmental sustainability in clinical practice examines critical care. The challenge isn't entirely a clinical one, because achieving net zero will depend on commitment across healthcare professions, engineering, waste management, hospital leadership, and beyond. A research paper assessing the value of routine monitoring of people being treated with methotrexate finds that frequency of monitoring should be adjusted according to risk, reducing the burden of work on clinical staff and making life more manageable for patients (doi:10.1136/bmj-2022-074678 doi:10.1136/bmj.p1120).1819 The difficulty here is one of getting research into practice, a timescale of 17 years by some estimates.

Application of virtual simulation in clinical skills and operation courses.

Aim: This study investigated the effectiveness and prospect of applying virtual simulation operation (VSO) as a novel teaching tool in clinical skill and operation courses. Methods: A comparative test and survey study on the teaching effect of VSO was conducted with the clinical skill and operation course as the test course. The test group students received offline courses combined with online VSO practice. In contrast, the control group students received offline courses combined with instructional video review. The two groups were assessed using the Chinese medical school clinical medicine professional level test and a questionnaire survey. Results: The test group students scored significantly higher than the control group in the skills test (score difference: 3.43, 95% CI: 2.05-4.80) (p < 0.001). Additionally, a significant increase in the percentage of high-and intermediate-score ranges and a decrease in the percentage of low-score ranges was observed (p < 0.001). According to the questionnaire survey, 80.56% of the students were willing to continue using virtual simulation in their subsequent clinical skill and operation learning. Further, 85.19% of the students believed that the VSO is superior because it is unrestricted by time and space and can be performed anywhere and anytime compared to traditional operation training. Conclusion: VSO teaching can improve skills and examination performance. An entirely online operation that does not need special equipment can break through the spatiotemporal limitations of traditional skills courses. VSO teaching also suits the ongoing COVID-19 pandemic situation. Virtual simulation, a new teaching tool, has good application prospects.

Questioning global health in the times of COVID-19: Re-imagining primary health care through the lens of politics of knowledge

The advent of the COVID-19 pandemic and the inequitable response to it has created a space for rethinking the knowledge translation that informs current health policy formulation and planning. Wide recognition of the failure of global health governance and national health systems has led to calls for reviving the Primary Health Care (PHC) agenda for post-COVID health systems development. Despite the joint international declaration on PHC made four decades ago, it has had limited application. This paper argues that the recent attempts to rethink PHC will prove inadequate without analysing and learning from the politics of knowledge (PoK) underlying global health policy and planning. Even with the growing relevance of the spirit of the Alma-Ata Declaration (1978) and its operationalisation as detailed in the report of conference proceedings, reassessment of reasons for its limited implementation continues to be located largely in the political economy of the medical establishment, the international economic order or in national governance flaws. Failure to address the dominant knowledge paradigm in the Alma Ata articulation of PHC has contributed to its limited application. This calls for expansion in the analysis from knowledge translation to generation and hierarchisation of knowledge. The paper discusses how the application of PoK as an analytical lens helps understand the power equations underlying the process of knowledge generation and its translation into policy and practice. Beneath the techno-centric and commodified health system is the dominant ‘knowledge' system whose foundations and assumptions ought to be interrogated. By following a PoK approach, a reorientation of thinking about the relationship between various forms of knowledge and knowledge holders is anticipated. A new health service system design is outlined—translating the spirit of PHC of 1978 into a ‘PHC Version 2.0'—that addresses the PoK gap in operational terms, with an approach to guide all levels of healthcare. It suggests how the world can be empowered to respond better by engaging with diverse ontologies and epistemologies to conceptualise knowledge and frame policies. Further, in the contexts of Asia, Africa and Latin America, it can contribute to the development of self-reliance to democratise general health policy and planning in the post-pandemic period.

Blended teaching of medical parasitology in China during COVID-19 pandemic.

The COVID-19 pandemic has promoted the development of online teaching in various educational institutions. Different online teaching practice has shown advantages and potential problems. The combination of online and offline teaching (mixed teaching) is a new teaching practice that can exert its advantages simultaneously, and has been wildly used during the COVID-19 pandemic, even being extended to the post-pandemic era. Medical parasitology is a foundation course for medicine and a bridging course towards clinical medicine and preventive medicine. The traditional teaching of medical parasitology has presented many limitations, including outdated teaching concepts and practices, and the disconnection between theory teaching and practice teaching. In response to these difficulties, many innovative ideas and measures have been taken o reform the teaching practice of the foundation medical courses, including updating teaching program, adopting innovative teaching practice (such as blended teaching), and promoting the teaching evaluation method. In this paper, we concluded the blended teaching tools, platforms, manners, effects and evaluation methods in medical parasitology in China during the COVID-19 pandemic to provide information for the teaching reform in the post-pandemic era.Copyright © 2022, National Institute of Parasitic Diseases. All rights reserved.

Medical-engineering Cross-innovation Postgraduate Talent Training

At the beginning of the new year of 2020, the new coronavirus swept across the motherland. Scientific researchers throughout the country overcame scientific difficulties and wrote papers for the motherland. Under the challenge of the epidemic situation, medical workers in the front saved the dying and healed the wounded, while the scientific researchers in the rear tackled scientific and technological problems. The two sides cooperated sincerely to unify medical practice and theoretical development, and effectively improved the scientific and technological level of China's medical industry. Health care is closely related to human survival, development and quality of life. At present, mankind is still facing the threat of major diseases, and the development of medical and health services has increasingly shown strategic significance to national security, social stability and even national survival. This article introduces a new model of talent cultivation at the graduate level. The cross-dissolution of clinical medicine and manufacturing engineering produces novel ideas and new technologies.

Hiv and Global Health in a Pandemic Era

Four broad themes run through this year's N'Galy-Mann lecture: clinical medicine, HIV, health security, and global health. Three patterns of disease characterized medicine in East Africa at the time that AIDS was first described in the United States: diseases of poverty, mainly infectious;non-communicable diseases with differing international epidemiology;and classic tropical diseases restricted in distribution by ecologic needs of parasites and vectors. Limited resources did not prevent the practice of good medicine under adverse circumstances, nor application of basic principles of research. The recognition of a second AIDS virus (HIV-2) in West Africa in the mid-late 1980s required applied research to assess implications and potential global impact of this novel infection. CDC established a second collaborative research site in sub-Saharan Africa, Projet RETRO-CI, in Abidjan, Cote d'Ivoire (the first was Projet SIDA in the Democratic Republic of Congo, where N'Galy and Mann made seminal contributions). Controversy around HIV-2 diagnosis, transmission, and pathogenicity was slowly resolved through West African research showing HIV-2 was an AIDS-causing pathogen, slower than HIV-1 in its progression, and less transmissible until late in the course of infection. Mother-to-child transmission was exceptionally rare. Claims that HIV-2 protected against HIV-1 were not substantiated. Projet RETRO-CI clarified the spectrum of HIVassociated disease and the dominant role of tuberculosis. Placebo-controlled trials demonstrated efficacy of short-course zidovudine for prevention of perinatal transmission of HIV-1, and of cotrimoxazole prophylaxis in reducing hospitalization and mortality in persons with HIV. Global health today is dominated by discourse around health security. The West African and Congolese Ebola epidemics since 2014 aroused strong declarations, yet the world was poorly prepared to address the pandemic of COVID-19. Health in the world has changed substantially since AIDS emerged. As 2030, the year for delivery on the Sustainable Development Goals, approaches, development assistance for health remains essential to address traditional, unfinished commitments yet does not match today's global burden of disease. CROI attendees are encouraged to remember colleagues lost to COVID-19 and other challenges;to assess priorities in today's global health, including relating to HIV;and to reflect on what issues? N'Galy and Mann would focus on today.

A practical guide to statistics for general practice

EVIDENCE-BASED MEDICINE is a well-established part of general practice in Australia.1 Understanding research is embedded within the current curriculum of The Royal Australian College of General Practitioners (RACGP), with the ability to discuss 'scientific and statistical information' for clinical decisions listed as a required skillset for general practitioners (GPs).2 In the past few years, the COVID-19 pandemic has further highlighted that interpreting epidemiology and statistics is not only relevant for GP academics, but is also an integral part of clinical care.3 For example, GPs are often the first point of contact for patients asking about the evidence for masks, diagnostic accuracy of COVID-19 tests, vaccine efficacy and effectiveness of new antiviral treatments. In clinical practice, framing a research question, conducting a database search and critical appraisal of the selected paper are key first steps in interpreting and using research evidence.

This Week in the Journal

Issue Highlights, April 02, 2020Timing of Endoscopy for Acute GI BleedingMDR Bacterial Infection in the U.S.Anorexia NervosaTuberculosis in 2020Stigma and the Toll of Addiction

Effect of Acupressure on Senior Nursing Students' Anxiety during the COVID-19 Pandemic: A Randomized Controlled Clinical Trial

Background: The transition to distance learning in nursing education during the COVID-19 pandemic, where clinical practice is critical, may have caused senior nursing students to experience a sense of graduating without sufficient skills and experience anxiety in addition to the anxiety caused by the pandemic. Non-pharmacological methods such as acupressure may be helpful in reducing students' anxiety. Aim: This study was conducted to determine the effect of acupressure on senior nursing students' anxiety levels during the COVID-19 pandemic. Methodology: This prospective, two-armed (1:1), randomized controlled study included fifty-two senior nursing students at a university nursing department. While the experimental group (n=26) applied acupressure to the LI4, HT7, and EX-HN3 points three times a week for four weeks, acupressure was not applied to the control group (n=26). Data were collected at baseline and at the end of four weeks using the State-Trait Anxiety Inventory (STAI). Results: At the end of four weeks, there was no significant difference between the STAI-State and STAI-Trait scores of the experimental and control groups (p>0.05). The STAI-State score of the experimental group decreased significantly in the fourth week compared to the baseline (p<0.05). Conclusion: Research findings revealed that self-administered acupressure by senior nursing students was effective in reducing moderate state anxiety during the pandemic, but not trait anxiety.

Expert Consensus on Rapid SARS-CoV-2 Antigen Testing.

The epidemic of the highly contagious, long lasting and widely popular coronavirus disease 2019 (COVID-19) has imposed a huge burden to the global public health. As one of the key methods for early diagnosis of COVID-19 infection, rapid acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen testing has been gradually applied in China. To address concerns raised by both health care workers and the public, based on the latest research and clinical practices, the Sub-committee of the Clinical Microbiology Laboratory of the Chinese Hospital Association proposed"Expert Consensus on Rapid SARS-CoV-2 Antigen Testing(2022)". The consensus panel is composed of experts from multiple disciplines, including laboratory medicine, clinical medicine, infection control, public health, research and development of in vitro diagnostic products. The consensus describes its principle, technological characteristics, results interpretation and, disposal recommendations, and analyzes the strategies and matters needing attention in different application scenarios. We expect the consensus to help correct understanding and application of rapid SARS-CoV-2 antigen testing in the diagnosis, treatment, prevention, and control of COVID-19.Copyright © 2022, Peking Union Medical College Hospital. All rights reserved.

Digital Health Technologies in Mental Health Care: Changing Perspectives of Health Care Professionals from 2019 to 2021

IntroductionDemand for digital mental health tools has risen since the start of the COVID-19 pandemic;however, their evolving use in mental health care is not well understood. We surveyed mental health care professionals (HCPs) before and after the onset of the pandemic and assessed how use of and attitudes about digital technology changed.MethodsWe distributed a digital health survey to HCPs in the United States in 2019 (pre-pandemic;N = 141) and in 2021 (during the pandemic;N = 151). Both surveys recorded the respondents' perceived barriers to integrating new digital health technologies and the tools they currently used in their practice.ResultsHCP use of telemedicine increased from 47% of respondents in 2019 to 81% in 2021, as did the use of mHealth sensors (2% vs 10%). Patient comfort with technology remained one of the biggest barriers to implementing new digital tools (40% vs 43%), while difficulty integrating digital tools into clinical practice became less common (40% vs 32%). Data management (19% vs 10%) and patient acceptability (19% vs 13%) were cited less often as barriers in 2021. Respondents' thoughts on what can be most improved by digital technology shifted substantially, with increased access to care rising from 27% of responses in 2019 to 46% in 2021.ConclusionsThe pandemic has changed how HCPs perceive digital health technologies and how they implement these tools in clinical practice. A growing number of HCPs believe increased access to care is the outcome that technology can most improve.FundingOtsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA