Polypharmacy of Older Surgical Patients With Extremity Fractures.

Introduction: Fractures are often caused by falls in older people. Among various causes of falls, polypharmacy is known to be a risk of falls. Furthermore, potentially inappropriate medicines (PIMs), which interact with polypharmacy, include the drugs involved in falls. Here, we primarily aimed to investigate the prescribed drugs in older surgical patients with extremity fractures to determine the frequency of polypharmacy and identify PIMs. The second aim was to clarify the characterization of prescribed drugs of older patients with hip fracture. Materials and Methods: We retrospectively collected the following clinical data of consecutive patients aged ≥65 years who underwent surgery for extremity fractures at our hospital between April 2019 and March 2021. A total of 19 categories were considered as PIMs. The Poisson regression models were used to examine the association between the number of prescribed drugs and hip fracture prevalence. Results: A total of 590 patients were reviewed. Our data showed that 55% of older patients with extremity fractures took ≥6 prescription drugs. The frequency of prescription of hypnotics, antithrombotic drugs, diuretics, and non-steroidal anti-inflammatory drugs was comparatively high among the 19 categories of PIMs. Multivariable analysis revealed that polypharmacy was significantly associated with hip fractures. Among PIMs, antithrombotic drugs and diuretics were significantly associated with the prevalence of hip fractures. Finally, we found a significant positive association between the prevalence of hip fracture and the number of drug categories of PIMs among older patients with extremity fractures. Conclusions: The present study clarified the characterization of the prescribed drugs in older surgical patients with extremity fractures. Special attention should be paid to hip fractures of older patients with polypharmacy or prescribed with many drugs categories of PIMs, particularly antithrombotic drugs and diuretics.

External validation and update of the International Medical Prevention Registry on Venous Thromboembolism bleeding risk score for predicting bleeding in acutely ill hospitalized medical patients: a retrospective single-center cohort study in Japan.

BACKGROUND: The International Medical Prevention Registry for Venous Thromboembolism (IMPROVE) Bleeding Risk Score is the recommended risk assessment model (RAM) for predicting bleeding risk in acutely ill medical inpatients in Western countries. However, few studies have assessed its predictive performance in local Asian settings. METHODS: We retrospectively identified acutely ill adolescents and adults (aged ≥ 15 years) who were admitted to our general internal medicine department between July 5, 2016 and July 5, 2021, and extracted data from their electronic medical records. The outcome of interest was the cumulative incidence of major and nonmajor but clinically relevant bleeding 14 days after admission. For the two-risk-group model, we estimated sensitivity, specificity, and positive and negative predictive values (PPV and NPV, respectively). For the 11-risk-group model, we estimated C statistic, expected and observed event ratio (E/O), calibration-in-the-large (CITL), and calibration slope. In addition, we recalibrated the intercept using local data to update the RAM. RESULTS: Among the 3,876 included patients, 998 (26%) were aged ≥ 85 years, while 656 (17%) were hospitalized in the intensive care unit. The median length of hospital stay was 14 days. Clinically relevant bleeding occurred in 58 patients (1.5%), 49 (1.3%) of whom experienced major bleeding. Sensitivity, specificity, NPV, and PPV were 26.1% (95% confidence interval [CI]: 15.8-40.0%), 84.8% (83.6-85.9%), 98.7% (98.2-99.0%), and 2.5% (1.5-4.3%) for any bleeding and 30.9% (95% CI: 18.8-46.3%), 84.9% (83.7-86.0%), 99.0% (98.5-99.3%), and 2.5% (1.5-4.3%) for major bleeding, respectively. The C statistic, E/O, CITL, and calibration slope were 0.64 (95% CI: 0.58-0.71), 1.69 (1.45-2.05), - 0.55 (- 0.81 to - 0.29), and 0.58 (0.29-0.87) for any bleeding and 0.67 (95% CI: 0.60-0.74), 0.76 (0.61-0.87), 0.29 (0.00-0.58), and 0.42 (0.19-0.64) for major bleeding, respectively. Updating the model substantially corrected the poor calibration observed. CONCLUSIONS: In our Japanese cohort, the IMPROVE bleeding RAM retained the reported moderate discriminative performance. Model recalibration substantially improved the poor calibration obtained using the original RAM. Before its introduction into clinical practice, the updated RAM needs further validation studies and an optimized threshold.

Radiographic and endoscopic screening to reduce gastric cancer mortality: a systematic review and meta-analysis.

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.

Association between intrarenal venous flow from Doppler ultrasonography and acute kidney injury in patients with sepsis in critical care: a prospective, exploratory observational study.

BACKGROUND: Intrarenal venous flow (IRVF) patterns assessed using Doppler renal ultrasonography are real-time bedside visualizations of renal vein hemodynamics. Although this technique has the potential to detect renal congestion during sepsis resuscitation, there have been few studies on this method. We aimed to examine the relationship between IRVF patterns, clinical parameters, and outcomes in critically ill adult patients with sepsis. We hypothesized that discontinuous IRVF was associated with elevated central venous pressure (CVP) and subsequent acute kidney injury (AKI) or death. METHODS: We conducted a prospective observational study in two tertiary-care hospitals, enrolling adult patients with sepsis who stayed in the intensive care unit for at least 24 h, had central venous catheters placed, and received invasive mechanical ventilation. Renal ultrasonography was performed at a single time point at the bedside after sepsis resuscitation, and IRVF patterns (discontinuous vs. continuous) were confirmed by a blinded assessor. The primary outcome was CVP obtained at the time of renal ultrasonography. We also repeatedly assessed a composite of Kidney Disease Improving Global Outcomes of Stage 3 AKI or death over the course of a week as a secondary outcome. The association of IRVF patterns with CVP was examined using Student's t-test (primary analysis) and that with composite outcomes was assessed using a generalized estimating equation analysis, to account for intra-individual correlations. A sample size of 32 was set in order to detect a 5-mmHg difference in CVP between IRVF patterns. RESULTS: Of the 38 patients who met the eligibility criteria, 22 (57.9%) showed discontinuous IRVF patterns that suggested blunted renal venous flow. IRVF patterns were not associated with CVP (discontinuous flow group: mean 9.24 cm H2O [standard deviation: 3.19], continuous flow group: 10.65 cm H2O [standard deviation: 2.53], p = 0.154). By contrast, the composite outcome incidence was significantly higher in the discontinuous IRVF pattern group (odds ratio: 9.67; 95% confidence interval: 2.13-44.03, p = 0.003). CONCLUSIONS: IRVF patterns were not associated with CVP but were associated with subsequent AKI in critically ill adult patients with sepsis. IRVF may be useful for capturing renal congestion at the bedside that is related to clinical patient outcomes.

The effect of introducing a nurse-practitioner-led peripherally inserted central venous catheter placement program on the utilization of central venous access device: A retrospective study in Japan.

BACKGROUND: Nurse-led peripherally inserted central venous catheter (PICC) placement teams are common in western hospitals, but they are still in their infancy in Japan. Although implementing a dedicated program may improve ongoing vascular-access management, the direct hospital-level effects of launching a nurse-led PICC team on specific outcomes have not been formally investigated. OBJECTIVES: To evaluate the effect of introducing a nurse practitioner (NP)-led PICC-placement program on subsequent utilization of centrally inserted central catheters (CICCs) and to contrast the quality of PICC placements conducted by physicians and NPs. MATERIALS AND METHODS: Patients who underwent central venous access devices (CVADs) between 2014 and 2020 at a university hospital in Japan were evaluated retrospectively using an interrupted time-series analysis on the trend for monthly CVAD utilization and logistic regression and propensity score-based analyses for PICC-related complications. RESULTS: Among 6007 CVAD placements, 2230 PICCs were inserted into 1658 patients (725 by physicians and 1505 by NPs). The monthly number of CICC utilization fell from 58 in April 2014 to 38 in March 2020, while PICC placements by the NP PICC team increased from 0 to 104. The implementation of the NP PICC program reduced the immediate rate (by 35.5; 95% confidence interval [CI]: 24.1-46.9; p < 0.001) and post-intervention trend (by 2.3; 95% CI: 1.1-3.5; p < 0.001) of monthly CICC utilization. Overall immediate complication rates were lower in the NP group than the physician group (1.5% vs 5.1%; adjusted odds ratio = 0.31; 95% CI: 0.17-0.59; p < 0.001). The cumulative incidences of central line-associated bloodstream infections were comparable between the NP and physician groups (5.9% vs 7.2%; adjusted hazard ratio = 0.96; 95% CI: 0.53-1.75; p = .90). CONCLUSIONS: This NP-led PICC program reduced CICC utilization without affecting the quality of PICC placement or complication rate.

External Validation of the Padua and IMPROVE-VTE Risk Assessment Models for Predicting Venous Thromboembolism in Hospitalized Adult Medical Patients: A Retrospective Single-Center Study in Japan.

Objectives: To assess the external validity of the Padua and International Medical Prevention Registry on Venous Thromboembolism (IMPROVE-VTE) risk assessment models (RAMs) for predicting venous thromboembolism (VTE) within 90 days of admission among hospitalized medical patients in Japan. Materials and Methods: A university hospital cohort comprising 3876 consecutive patients ages ≥15 years admitted to a general internal medicine department between July 2016 and July 2021 was retrospectively analyzed using data extracted from their medical records. Results: A total of 74 VTE events (1.9%), including six cases with pulmonary embolism (0.2%), were observed. Both RAMs had poor discriminative performance (C-index=0.64 for both) and generally underestimated VTE risks. However, recalibrating the IMPROVE-VTE RAM to update the baseline hazard improved the calibration (calibration slope=1.01). Decision curve analysis showed that a management strategy with no prediction model outperformed a clinical management strategy guided by the originally proposed RAMs. Conclusions: Both RAMs require an update to function in this particular setting. Further studies with a larger-sized cohort, including re-estimation of the individual regression coefficients with additional, more context-specific predictors, are needed to create a useful model that would help advance risk-oriented VTE prevention programs.

Discontinuation of admission screening for coronavirus disease 2019 (COVID-19) and the impact on in-hospital clusters of COVID-19: Experience at a tertiary-care center.

We evaluated the impact of discontinuing universal preadmission screening for severe acute respiratory coronavirus virus 2 (SARS-CoV-2) on the occurrence of nosocomial clusters of coronavirus disease 2019 (COVID-19) during the SARS-CoV-2 o (omicron) variant period. No increasing trend in nosocomial clusters was observed during community-based surges before and after discontinuation. This finding supports the safety of the practice change.

Post-discharge clinical, laboratory and radiographic features of coronavirus disease 2019 (COVID-19) patients at university hospitals in Japan.

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.

External validation of the Michigan PICC catheter-associated bloodstream infections score (MPC score) for predicting the risk of peripherally inserted central catheter-associated bloodstream infections: A single-center study in Japan.

The Michigan peripherally inserted central catheter-associated bloodstream infection score (MPC score) had been developed for hospitalized medical patients but had not been externally validated. A retrospective analysis of a clinically heterogeneous case-mix in a university hospital cohort in Japan failed to validate its originally reported good performance.

An early return-to-work program for COVID-19 close contacts in healthcare during the Omicron wave in Japan.

During the coronavirus disease 2019 (COVID-19) pandemic, maintaining adequate staffing in healthcare facilities is important to provide a safe work environment for healthcare workers (HCWs). Japan's early return-to-work (RTW) program may be a rational strategy at a time when there is an increased demand for the services of HCWs. We assessed whether the early RTW program for HCWs who have been in close contact with a COVID-19 case in our hospital was justified. Close contacts were identified according to the guidance document of the World Health Organization. HCWs who met all of the following conditions were eligible to apply to an early RTW program: (1) difficult to replace with another HCW, (2) received the third dose of a COVID-19 mRNA vaccine, (3) a negative COVID-19 antigen test before each work shift, and (4) consent from relevant HCWs and their managers to participate in the program. Between January and March 2022, 256 HCWs were identified as close contacts (median age, 35 years; 192 female). Thirty-seven (14%) secondary attack cases of COVID-19 were detected. Among 141 HCWs (55%) who applied to the early RTW program, nurses and physicians comprised about three-quarters of participants, with a higher participation rate by physicians (78%) than nurses (59%). Eighteen HCWs tested positive for COVID-19 by the sixth day after starting the early RTW program. No COVID-19 infection clusters were reported during the observation period. These findings suggest that the early RTW program for COVID-19 close contacts was a reasonable strategy for HCWs during the Omicron wave.

Short-course remdesivir for healthcare-associated COVID-19: Case series from a non-acute care hospital.

Healthcare-associated COVID-19 among vulnerable patients leads to disproportionate morbidity and mortality. Early pharmacologic intervention may reduce negative sequelae and improve survival in such settings. This study aimed to describe outcome of patients with healthcare-associated COVID-19 who received early short-course remdesivir therapy. We reviewed the characteristics and outcome of hospitalized patients who developed COVID-19 during an outbreak that involved two wards at a non-acute care hospital in Japan and received short-course remdesivir. Forty-nine patients were diagnosed with COVID-19, 34 on a comprehensive inpatient rehabilitation ward and 15 on a combined palliative care and internal medicine ward. Forty-seven were symptomatic and 46 of them received remdesivir. The median age was 75, and the median Charlson comorbidity index was 6 among those who received it. Forty-one patients had received one or two doses of mRNA vaccines, while none had received a third dose. Most patients received 3 days of remdesivir. Of the patients followed up to 14 and 28 days from onset, 41/44 (95.3%) and 35/41(85.4%) were alive, respectively. Six deaths occurred by 28 days in the palliative care/internal medicine ward and two of them were possibly related to COVID-19. Among those who survived, the performance status was unchanged between the time of onset and at 28 days.

Association of Repeated Blood Cultures With Mortality in Adult Patients With Gram-Negative Bacilli Bacteremia: A Systematic Review and Meta-analysis.

Background: Performing repeat blood cultures after an initial positive culture (ie, follow-up blood cultures [FUBCs]) in patients with gram-negative bacilli (GNB) bacteremia is controversial. We aimed to comprehensively review the association of FUBCs with improvement in patient-relevant clinical outcomes in GNB bacteremia. Methods: We performed a systematic review and random-effects meta-analysis to calculate summary effect estimates. We used hazard ratios as the effect measure. The primary outcome was 30-day or in-hospital mortality, and secondary outcomes were length of treatment and length of hospital stay. We searched PubMed, Embase, and Cochrane Central Register of Controlled Trials (Central) without language restrictions from inception to April 29, 2022. Original clinical studies evaluating the association between FUBCs and mortality in adult patients with GNB bacteremia were included. FUBC details were reviewed. Two independent reviewers used the Risk of Bias in Non-randomised Studies of Interventions tool. Results: We identified 9 eligible retrospective studies. In total, 7778 hospitalized patients with GNB bacteremia were included. The studies were clinically heterogeneous and had a critical risk of bias. The utilization of FUBCs varied across studies (18%-89%). Random-effects meta-analysis of covariate-adjusted estimates found that FUBC use was associated with reduced mortality. Although not a result of the meta-analysis, lengths of treatment and hospital stay were longer for patients with FUBCs than for those without. Adverse events were not reported. Conclusions: FUBC acquisition was associated with lower mortality and longer hospital stay and treatment duration in GNB bacteremia. The risk of bias was critical, and no firm data were available to support mechanisms.

Serial high-sensitivity cardiac troponin testing for the diagnosis of myocardial infarction: a scoping review.

OBJECTIVES: We aimed to assess the diversity and practices of existing studies on several assays and algorithms for serial measurements of high-sensitivity cardiac troponin (hs-cTn) for risk stratification and the diagnosis of myocardial infarction (MI) and 30-day outcomes in patients suspected of having non-ST-segment elevation MI (NSTEMI). METHODS: We searched multiple databases including MEDLINE, EMBASE, Science Citation Index, the Cochrane Database of Systematic Reviews and the CENTRAL databases for studies published between January 2006 and November 2021. Studies that assessed the diagnostic accuracy of serial hs-cTn testing in patients suspected of having NSTEMI in the emergency department (ED) were eligible. Data were analysed using the scoping review method. RESULTS: We included 86 publications, mainly from research centres in Europe, North America and Australasia. Two hs-cTn assays, manufactured by Abbott (43/86) and Roche (53/86), dominated the evaluations. The studies most commonly measured the concentrations of hs-cTn at two time points, at presentation and a few hours thereafter, to assess the two-strata or three-strata algorithm for diagnosing or ruling out MI. Although data from 83 studies (97%) were prospectively collected, 0%-90% of the eligible patients were excluded from the analysis due to missing blood samples or the lack of a final diagnosis in 53 studies (62%) that reported relevant data. Only 19 studies (22%) reported on head-to-head comparisons of alternative assays. CONCLUSION: Evidence on the accuracy of serial hs-cTn testing was largely derived from selected research institutions and relied on two specific assays. The proportions of the eligible patients excluded from the study raise concerns about directly applying the study findings to clinical practice in frontline EDs. PROSPERO REGISTRATION NUMBER: CRD42018106379.

Treatment of acute hypernatremia caused by sodium overload in adults: A systematic review.

BACKGROUND: Rapid-onset, acute hypernatremia caused by sodium overload is a rare, life-threatening condition. Although experts recommend rapid correction of sodium concentration [Na] based on pathophysiological theories, only a few reports have documented the specific details of sodium correction methods. The objective of this study was to systematically review the reported treatment regimens, achieved [Na] correction rates, and treatment outcomes. METHODS: PubMed, Ichushi-database, and references without language restrictions, from inception to January 2021, were searched for studies that described ≥1 adult (aged ≥18 years) patients with rapid-onset hypernatremia caused by sodium overload, whose treatment was initiated ≤12 hours from the onset. The primary outcome of interest was the [Na] correction rate associated with mortality. RESULTS: Eighteen case reports (18 patients; median [Na], 180.5 mEq/L) were included. The cause of sodium overload was self-ingestion in 8 patients and iatrogenic sodium gain in 10 patients; baseline [Na] and symptoms at presentation were comparable for both groups. Individualized rapid infusion of dextrose-based solutions was the most commonly adopted fluid therapy, whereas hemodialysis was also used for patients already treated with hemodialysis. The correction rates were more rapid in 13 successfully treated patients than in 5 fatal patients. The successfully treated patients typically achieved [Na] ≤160 within 8 hours, [Na] ≤150 within 24 hours, and [Na] ≤145 within 48 hours. Hyperglycemia was a commonly observed treatment-related adverse event. CONCLUSION: The limited empirical evidence derived from case reports appears to endorse the recommended, rapid, and aggressive sodium correction using dextrose-based hypotonic solutions.

Antibody Responses to BNT162b2 Vaccination in Japan: Monitoring Vaccine Efficacy by Measuring IgG Antibodies against the Receptor-Binding Domain of SARS-CoV-2.

To fight severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes coronavirus disease 2019 (COVID-19), mass vaccination has begun in many countries. To investigate the usefulness of a serological assay to predict vaccine efficacy, we analyzed the levels of IgG, IgM, and IgA against the receptor-binding domain (RBD) of SARS-CoV-2 in the sera from BNT162b2 vaccinated individuals in Japan. This study included 219 individuals who received two doses of BNT162b2. The levels of IgG, IgM, and IgA against RBD were measured by enzyme-linked immunosorbent assay before and after the first and second vaccination, respectively. The relationship between antibody levels and several factors, including age, gender, and hypertension were analyzed. Virus-neutralizing activity in sera was measured to determine the correlation with the levels of antibodies. A chemiluminescent enzyme immunoassay (CLEIA) method to measure IgG against RBD was developed and validated for the clinical setting. The levels of all antibody isotypes were increased after vaccination. Among them, RBD-IgG was dramatically increased after the second vaccination. The IgG levels in females were significantly higher than in males. There was a negative correlation between age and IgG levels in males. The IgG levels significantly correlated with the neutralizing activity. The CLEIA assay measuring IgG against RBD showed a reliable performance and a high correlation with neutralizing activity. Monitoring of IgG against RBD is a powerful tool to predict the efficacy of SARS-CoV-2 vaccination and provides useful information in considering a personalized vaccination strategy for COVID-19. IMPORTANCE Mass vaccination campaigns using mRNA vaccines against SARS-CoV-2 have begun in many countries. Serological assays to detect antibody production may be a useful tool to monitor the efficacy of SARS-CoV-2 vaccination in individuals. Here, we reported the induction of antibody isotype responses after the first and second dose of the BNT162b2 vaccine in a well-defined cohort of employees in Japan. We also reported that age, gender, and hypertension are associated with differences in antibody response after vaccination. This study not only provides valuable information with respect to antibody responses after BNT162b2 vaccination in the Japanese population but also the usefulness of serological assays for monitoring vaccine efficacy in clinical laboratories to determine a personalized vaccination strategy for COVID-19.

Effectiveness of decision aids on cancer-screening decision-making: an umbrella review protocol.

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.

Delayed Injection Site Reaction After mRNA-1273 Vaccination in Japan: A Retrospective, Cross-Sectional Study.

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.