日比野 将也

BACKGROUND: Decision aids (DAs), compared to no DAs, help improve the key aspects of shared decision-making, including increased knowledge, discussion frequency, and reduction in decisional conflict. However, systematic reviews have reported varied conclusions on screening uptake, and which DAs are superior to alternative forms in shared decision-making for cancer screening has not been comprehensively reviewed. METHODS: An overview of systematic reviews was performed. Multiple databases were searched up to December 31, 2023, for systematic reviews of randomized controlled trials (RCTs) and non-randomized comparative studies (NRCSs) of any size that assessed a decision aid aimed to facilitate cancer-screening decision making communications. Dual screening of abstracts and full-text reports, dual data extraction and quality assessment, and qualitative synthesis were performed. RESULTS: The 22 eligible publications included 24 reviews on cancer screening DAs for a single specific cancer (8, 8, 7, and 1 on prostate, breast, colorectal, and lung cancer, respectively) and three reviews on multiple aggregate cancers. Individual reviews were based on different primary study designs (92 RCTs and 37 NRCSs); each study was infrequently cited (median citation count 2; range 1-9). Although the DAs had variable formats and delivery methods, the reviews generally focused on use and non-use comparisons. DAs decreased the intention or actual uptake for prostate and breast cancer screening, but increased it for colorectal cancer screening. DAs were associated with increased knowledge, well-informed choice, and reduced decisional conflict, regardless of cancer type. Only four reviews on comparative effectiveness between alternative formats of DAs (based on 14 RCTs and 2 NRCSs) failed to conclude on the specific format that was superior to others. DISCUSSION: DAs improve cancer screening shared decision-making by boosting cancer screening knowledge and informed choice and lowering decisional conflict and may facilitate preference-based, individualized screening participation. Comparative data on different cancer screening DAs are limited. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42021235957.

BACKGROUND: Previous systematic reviews naïvely combined biased effects of screening radiography or endoscopy observed in studies with various designs. We aimed to synthesize currently available comparative data on gastric cancer mortality in healthy, asymptomatic adults by explicitly classifying the screening effects through study designs and types of intervention effects. METHODS: We searched multiple databases through October 31, 2022 for this systematic review and meta-analysis. Studies of any design that compared gastric cancer mortality among radiographic or endoscopic screening and no screening in a community-dwelling adult population were included. The method included a duplicate assessment of eligibility, double extraction of summary data, and validity assessment using the Risk Of Bias In Non-randomized Studies of Interventions tool. Bayesian three-level hierarchical random-effects meta-analysis synthesized data corrected for self-selection bias on the relative risk (RR) for per-protocol (PP) and intention-to-screen (ITS) effects. The study registration number at PROSPERO is CRD42021277126. FINDINGS: We included seven studies in which a screening program was newly introduced (median attendance rate, 31%; at moderate-to-critical risk of bias), and seven cohort and eight case-control studies with ongoing screening programs (median attendance rate, 21%; all at critical risk of bias); thus, data of 1,667,117 subjects were included. For the PP effect, the average risk reduction was significant for endoscopy (RR 0.52; 95% credible interval: 0.39-0.79) but nonsignificant for radiography (0.80; 0.60-1.06). The ITS effect was not significant for both radiography (0.98; 0.86-1.09) and endoscopy (0.94; 0.71-1.28). The magnitude of the effects depended on the assumptions for the self-selection bias correction. Restricting the scope to East Asian studies only did not change the results. INTERPRETATION: In limited-quality observational evidence from high-prevalence regions, screening reduced gastric cancer mortality; however, the effects diminished at a program level. FUNDING: National Cancer Center Japan; and Japan Agency for Medical Research and Development.

OBJECTIVES: Coronavirus disease 2019 (COVID-19) has affected nearly half million people in Japan. However, information on the prolonged symptoms as well as laboratory and radiographic findings after hospital discharge remains limited. METHODS: We retrospectively collected the symptoms, laboratory test results, and chest imaging results of COVID-19 patients at the time of the hospital admission and the ambulatory visits after discharge at two university hospitals between July and December 2020. PATIENTS: A total of 126 COVID-19 patients, including of 88 with mild to moderate disease and 38 with severe to critical disease, were included. The time between symptom onset and the first outpatient visit was 46 days (Interquartile range, 39 to 55). RESULTS: At the ambulatory visits, 36.5% of patients had at least one symptom. The most frequent symptom was shortness of breath (12.8%), followed by cough (11.1%), and fatigue (8.8%). Of 120 patients with post-discharge laboratory test results, 27 patients (22.5%) had abnormal alanine aminotransferase levels, and 35 patients (29.1%) had lymphocytopenia, including 24 and 27 mild and moderate patients. Of 122 patients with post-discharge chest computed tomography (CT) scans, 105 (83.3%) had abnormal findings. This abnormality was found in both mild to moderate and severe patients. CONCLUSIONS: Shortness of breath, abnormal liver function test results and chest CT images often persisted for at least one month after discharge, even when symptoms were mild or moderate during hospitalization.

INTRODUCTION: Although systematic reviews have shown how decision aids about cancer-related clinical decisions improve selection of key options and shared decision-making, whether or not particular decision aids, defined by their specific presentation formats, delivery methods and other attributes, can perform better than others in the context of cancer-screening decisions is uncertain. Therefore, we planned an overview to address this issue by using standard umbrella review methods to repurpose existing systematic reviews and their component comparative studies. METHODS AND ANALYSIS: We will search PubMed, Embase, the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects from inception through 31 December 2021 with no language restriction and perform full-text evaluation of potentially relevant articles. We will include systematic reviews of randomised controlled trials or non-randomised studies of interventions that assessed a decision aid about cancer-screening decisions and compared it with an alternative tool or conventional management in healthy average-risk adults. Two reviewers will extract data and rate the study validity according to standard quality assessment measures. Our primary outcome will be intended and actual choice and adherence to selected options. The secondary outcomes will include attributes of the option-selection process, achieving shared decision-making and preference-linked psychosocial outcomes. We will qualitatively assess study, patient and intervention characteristics and outcomes. We will also take special care to investigate the presentation format, delivery methods and quality of the included decision aids and assess the degree to which the decision aid was delivered and used as intended. If appropriate, we will perform random-effects model meta-analyses to quantitatively synthesise the results. ETHICS AND DISSEMINATION: Ethics approval is not applicable as this is a secondary analysis of publicly available data. The review results will be submitted for publication in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42021235957.

The incidence of delayed injection site reaction after the first dose of mRNA-1273 vaccine was 12.5% among females and 1.5% among males in a cohort of primarily elderly Japanese. After the second dose, 48.4% of those who could be contacted reported recurrence. The reaction may be relatively common among Asian females.

OBJECTIVE: Reverse transcription loop-mediated isothermal amplification (RT-LAMP) has been validated to diagnose several viral infections. However, its diagnostic accuracy in detecting SARS-CoV-2 in real-life clinical settings remains unclear. This study aimed to determine the diagnostic sensitivity and specificity of RT-LAMP compared to reverse transcription-quantitative polymerase chain reaction (RT-qPCR) over the disease course of COVID-19. METHODS: A total of 124 nasopharyngeal swab samples obtained from 24 COVID-19 patients were tested by RT-LAMP and RT-qPCR. Sensitivities and specificities of RT-LAMP compared with RT-qPCR were analyzed as a function of time from onset. RESULTS: Up to the 9th day after onset, the RT-LAMP had a positivity of 92.8%, and the sensitivity and specificity compared with RT-qPCR was 100%. However, after the 10th day after onset, the positivity of RT-LAMP decreased to less than 25%, and the concordance of positivity between the two methods was below 60%. The limit of detection of RT-LAMP was 6.7 copies/reaction. CONCLUSIONS: Until the 9th day after the onset of symptoms, RT-LAMP had the same diagnostic accuracy as RT-qPCR. These findings suggest that RT-LAMP can be used as a diagnostic tool for COVID-19 as an alternative to RT-qPCR in the acute symptomatic phase of COVID-19.

Favipiravir is an oral broad-spectrum inhibitor of viral RNA-dependent RNA polymerase that is approved for treatment of influenza in Japan. We conducted a prospective, randomized, open-label, multicenter trial of favipiravir for the treatment of COVID-19 at 25 hospitals across Japan. Eligible patients were adolescents and adults admitted with COVID-19 who were asymptomatic or mildly ill and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients were randomly assigned at a 1:1 ratio to early or late favipiravir therapy (in the latter case, the same regimen starting on day 6 instead of day 1). The primary endpoint was viral clearance by day 6. The secondary endpoint was change in viral load by day 6. Exploratory endpoints included time to defervescence and resolution of symptoms. Eighty-nine patients were enrolled, of whom 69 were virologically evaluable. Viral clearance occurred within 6 days in 66.7% and 56.1% of the early and late treatment groups (adjusted hazard ratio [aHR], 1.42; 95% confidence interval [95% CI], 0.76 to 2.62). Of 30 patients who had a fever (≥37.5°C) on day 1, times to defervescence were 2.1 days and 3.2 days in the early and late treatment groups (aHR, 1.88; 95% CI, 0.81 to 4.35). During therapy, 84.1% developed transient hyperuricemia. Favipiravir did not significantly improve viral clearance as measured by reverse transcription-PCR (RT-PCR) by day 6 but was associated with numerical reduction in time to defervescence. Neither disease progression nor death occurred in any of the patients in either treatment group during the 28-day participation. (This study has been registered with the Japan Registry of Clinical Trials under number jRCTs041190120.).