The Fragility of Statistically Significant Results in Randomized Clinical Trials for COVID-19

[Importance] Interpreting results from randomized clinical trials (RCTs) for COVID-19, which have been published rapidly and in vast numbers, is challenging during a pandemic. [Objective] To evaluate the robustness of statistically significant findings from RCTs for COVID-19 using the fragility index. [Design, Setting, and Participants] This cross-sectional study included COVID-19 trial articles that randomly assigned patients 1:1 into 2 parallel groups and reported at least 1 binary outcome as significant in the abstract. A systematic search was conducted using PubMed to identify RCTs on COVID-19 published until August 7, 2021. [Exposures] Trial characteristics, such as type of intervention (treatment drug, vaccine, or others), number of outcome events, and sample size. [Main Outcomes and Measures] Fragility index. [Results] Of the 47 RCTs for COVID-19 included, 36 (77%) were studies of the effects of treatment drugs, 5 (11%) were studies of vaccines, and 6 (13%) were of other interventions. A total of 138 235 participants were included in these trials. The median (IQR) fragility index of the included trials was 4 (1-11). The medians (IQRs) of the fragility indexes of RCTs of treatment drugs, vaccines, and other interventions were 2.5 (1-6), 119 (61-139), and 4.5 (1-18), respectively. The fragility index among more than half of the studies was less than 1% of each sample size, although the fragility index as a proportion of events needing to change would be much higher. [Conclusions and Relevance] This cross-sectional study found a relatively small number of events (a median of 4) would be required to change the results of COVID-19 RCTs from statistically significant to not significant. These findings suggest that health care professionals and policy makers should not rely heavily on individual results of RCTs for COVID-19

Development of eosinophilic granulomatosis with polyangiitis during the clinical course of microscopic polyangiitis: A case report

Rationale: Eosinophilic granulomatosis with polyangiitis (EGPA) is belongs to the antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) subgroups. EGPA, unlike other subgroups of AAV, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis, has the unique feature that both ANCA and eosinophilic inflammation are involved in its pathogenesis. Although AAV often relapses, there are currently no reports of EGPA developing during other subgroups of AAV. Herein, we document a case of EGPA that developed during the clinical course of MPA.Patient concerns: A 61-year-old Japanese woman was diagnosed with MPA based on interstitial lung disease and myeloperoxidase-ANCA positivity. After starting immunosuppression therapy, including prednisolone and tacrolimus, she was expected to achieve clinical remission. Nonetheless, she occasionally experienced MPA relapse, which required an increased prednisolone dose, rituximab, intravenous cyclophosphamide, and plasma exchange. Three years after MPA onset, she developed renal amyloidosis; thus, subcutaneous tocilizumab was added to her regimen. Following clinical remission, the administration interval of her subcutaneous tocilizumab therapy was extended and immunosuppressants were discontinued. She then developed bronchial asthma and mild eosinophilia (eosinophilic count: ~1000/μL). Further, a year later, she underwent total hip replacement using a titanium implant. Subsequently, she developed abnormal sensation in both hands, numbness, and muscle weakness, as well as palpable purpura and massive eosinophilia (eosinophilic count: ~8500/μL).Diagnosis: We diagnosed the patient with EGPA based on 5 items (asthma, multiple mononeuropathies, sinus abnormality, and extravascular eosinophils) of the 1990 American College of Rheumatology classification criteria.Interventions: We administered 400 mg/kg intravenous immunoglobulin for 5 consecutive days, 300 mg mepolizumab subcutaneously every 4 weeks, and 40 mg/day prednisolone following pulsed methylprednisolone therapy (1000 mg/day for 3 consecutive days).Outcomes: After these treatments, the patient’s symptoms improved, and eosinophilic count and inflammatory markers declined.Lessons: The present case suggests that EGPA can be induced by the development of eosinophilic inflammation in other subgroups of AAV.Abbreviations: AAV = ANCA-associated vasculitis, ANCA = antineutrophil cytoplasmic autoantibody, CCL = chemokine (C–C motif) ligands, CRP = C-reactive protein, EGPA = eosinophilic granulomatosis with polyangiitis, IL = interleukin, ILC2 = group 2 innate lymphoid cells, ILD = interstitial lung disease, MPA = microscopic polyangiitis, MPO = myeloperoxidase, mPSL = methylprednisolone, PSL = prednisolone, TAC = tacrolimus, TCZ = tocilizumab, Th2 = T helper 2

聖隷クリストファー大学看護基礎教育におけるシミュレーション教育の実践

紀要委員会企画Special Articles　本報告では、聖隷クリストファー大学看護基礎教育におけるシミュレーション教育の実践環境の構築、各領域における実践、教育力向上の取り組み、そして課題も含め今後の展望を報告する。本学は米国サミュエルメリット大学と2013 年に大学間交流協定を締結して以来、学生や教員が毎年、研修に赴きシミュレーション教育について学んできた。2016年に看護学部の教員有志によるワーキンググループが結成し、2017 年度より看護学部諮問委員会としてシミュレーション教育委員会が発足した。本学では、看護学部を中心にアクティブラーニングを実践するひとつの手法としてシミュレーション教育を検討し環境構築、研修会など学習の機会の提供、シミュレーションルームの機材および備品管理、シミュレーション教育実施の支援、広報活動など推進してきた。今後、シミュレーション教育を遂行する上で、以下の課題と展望がある。1．教育環境のさらなる充実、2．人員の確保、3．地域の拠点としてのシミュレーション教育の推進、4．活動のための運営資金の獲得である

聖隷クリストファー大学看護基礎教育における2020年度シミュレーション教育の実践報告

紀要委員会企画Special Articles　本報告では、聖隷クリストファー大学看護基礎教育における2020 年度のシミュレーション教育委員会の活動報告および各領域における実践について、以下の内容をふまえ報告する。　①シミュレーション教育の実践環境の構築および学内研修、②コロナ禍における通信設備・運用のテクニカルサポート、③シミュレーション教育の実践（看護学部各領域におけるシミュレーション教育の実践内容）、④看護学部シミュレーション教育ホームページ、⑤本学看護学部のシミュレーション教育に関する国内外の学会発表の実績　今後もシミュレーション教育を推進するための本学の課題である、教育環境のさらなる充実、人員の確保、地域の拠点としてのシミュレーション教育の推進、活動のための運営資金の獲得を目指すべく、近隣施設との連携、研究推進とともに、教員の理解と同意を得ながらさらなる教育環境の整備や教育力の向上のため邁進していく

Implementation of Molecular Autopsy for Sudden Cardiac Death in Japan --Focus Group Study of Stakeholders--

Background: We assessed the awareness of multidisciplinary healthcare professionals of the challenges related to implementation of molecular autopsy (MA) for sudden cardiac death (SCD) among children and young adults. Methods and Results: We conducted 11 focus groups with 31 multidisciplinary healthcare professionals, and categorized them into 2 themes: values, and challenges of MA implementation. The participants recognized 2 different values of MA: discovering the unknown cause of SCD, and SCD prevention among family members of victims. The coexistence of these values makes the MA process and role of professionals more complex. Participants were concerned about the psychological burden for bereaved family members and mentioned challenges in each process of the MA delivery system: obtaining consent, cause of death investigation, disclosing results, and preventive intervention. Conclusions: MA is a valuable procedure both in terms of forensic and preventive medicine. However, the dual meanings and complex characteristics of genetic information is a potential source of concern and confusion among healthcare professionals as well as bereaved family members. Increasing awareness among healthcare professionals of the MA process is essential for connecting all related areas of expertise