Effectiveness of primary series, first, and second booster vaccination of monovalent mRNA COVID-19 vaccines against symptomatic SARS-CoV-2 infections and severe diseases during the SARS-CoV-2 omicron BA.5 epidemic in Japan: vaccine effectiveness real-time surveillance for SARS-CoV-2 (VERSUS).

BACKGROUND: This study aimed to evaluate VE of primary, first, and second booster ancestral-strain monovalent mRNA COVID-19 vaccination against symptomatic infections and severe diseases in Japan. METHODS: We conducted a test-negative case-control study. We included medically attended episodes and hospitalizations involving individuals aged ≥16 with signs and symptoms from July to November 2022, when Omicron BA.5 was dominant nationwide. To evaluate VE, we calculated adjusted ORs of vaccination among test-positive versus test-negative individuals using a mixed-effects logistic regression. RESULTS: For VE against symptomatic infections among individuals aged 16 to 59, VE of primary vaccination at > 180 days was 26.1% (95% CI: 10.6-38.8%); VE of the first booster was 58.5% (48.4-66.7%) at ≤90 days, decreasing to 41.1% (29.5-50.8%) at 91 to 180 days. For individuals aged ≥60, VE of the first booster was 42.8% (1.7-66.7%) at ≤90 days, dropping to 15.4% (-25.9-43.2%) at 91 to 180 days, and then increasing to 44.0% (16.4-62.5%) after the second booster. For VE against severe diseases, VE of the first and second booster was 77.3% (61.2-86.7%) at ≤90 days and 55.9% (23.4-74.6%) afterward. CONCLUSION: mRNA booster vaccination provided moderate protection against symptomatic infections and high-level protection against severe diseases during the BA.5 epidemic in Japan.

Effect of Medical Fee Schedule Revisions on the Expansion of Nutritional Support Teams in Japan: An Interrupted Time-series Analysis.

Introduction: In 2018, the fee schedule for nutrition support teams (NSTs) in Japanese hospitals was changed. The change was intended to encourage more hospitals to establish NSTs, and this study aims to investigate whether this change had the desired effect. Specifically, we will look at the proportion of hospitals with NSTs before and after the 2018 revision to see if there was a significant increase in the number of hospitals with NSTs. Methods: The study analyzed administrative data from 10 Japanese prefectures dating from June 2015 to September 2021 using an interrupted time-series design. The analysis focused on all acute care hospitals within these prefectures and measured the percentage of hospitals with NSTs. Subgroup analyses were conducted based on hospital size and functions. In April 2018, the intervention, a fee schedule revision, was implemented. Results: We analyzed 1,471 acute care hospitals. Immediately after the intervention, the percentage of hospitals with NSTs increased by 4.59% (95% CI = 3.92%, 5.26%) and by 0.66% (95% CI = 0.57%, 0.75%) quarterly thereafter. We observed a marked increase in NST formation among large-sized (20.9%), medium-sized (28.0%), and highly acute care hospitals (hospitals with emergency medical care centers and intensive care units, 22.3% and 23.6%, respectively). We also noted a moderate increase among hospitals with convalescent rehabilitation units (10.1%) and a modest increase among small-sized hospitals (6.9%). Conclusions: Relaxation of the NST fee requirement increased the proportion of hospitals with NSTs in Japan, especially among larger and highly acute care hospitals.

Monitoring of gastric residual volume during enteral nutrition.

BACKGROUND: The main goal of enteral nutrition (EN) is to manage malnutrition in order to improve clinical outcomes. However, EN may increase the risks of vomiting or aspiration pneumonia during gastrointestinal dysfunction. Consequently, monitoring of gastric residual volume (GRV), that is, to measure GRV periodically and modulate the speed of enteral feeding according to GRV, has been recommended as a management goal in many intensive care units. Yet, there is a lack of robust evidence that GRV monitoring reduces the level of complications during EN. The best protocol of GRV monitoring is currently unknown, and thus the precise efficacy and safety profiles of GRV monitoring remain to be ascertained. OBJECTIVES: To investigate the efficacy and safety of GRV monitoring during EN. SEARCH METHODS: We searched electronic databases including CENTRAL, MEDLINE, Embase, and CINAHL for relevant studies on 3 May 2021. We also checked reference lists of included studies for additional information and contacted experts in the field. SELECTION CRITERIA: We included randomized controlled trials (RCTs), randomized cross-over trials, and cluster-RCTs investigating the effects of GRV monitoring during EN. We imposed no restrictions on the language of publication. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the search results for eligible studies and extracted trial-level information from each included study, including methodology and design, characteristics of study participants, interventions, and outcome measures. We assessed risk of bias for each study using Cochrane's risk of bias tool. We followed guidance from the GRADE framework to assess the overall certainty of evidence across outcomes. We used a random-effects analytical model to perform quantitative synthesis of the evidence. We calculated risk ratios (RRs) with 95% confidence intervals (CIs) for dichotomous and mean difference (MD) with 95% CIs for continuous outcomes. MAIN RESULTS: We included eight studies involving 1585 participants. All studies were RCTs conducted in ICU settings. Two studies (417 participants) compared less-frequent (less than eight hours) monitoring of GRV against a regimen of more-frequent (eight hours or greater) monitoring. The evidence is very uncertain about the effect of frequent monitoring of GRV on mortality rate (RR 0.91, 95% CI 0.60 to 1.37; I² = 8%; very low-certainty evidence), incidence of pneumonia (RR 1.08, 95% CI 0.64 to 1.83; heterogeneity not applicable; very low-certainty evidence), length of hospital stay (MD 2.00 days, 95% CI -2.15 to 6.15; heterogeneity not applicable; very low-certainty evidence), and incidence of vomiting (RR 0.14, 95% CI 0.02 to 1.09; heterogeneity not applicable; very low-certainty evidence). Two studies (500 participants) compared no GRV monitoring with frequent (12 hours or less) monitoring. Similarly, the evidence is very uncertain about the effect of no monitoring of GRV on mortality rate (RR 0.87, 95% CI 0.62 to 1.23; I² = 51%; very low-certainty evidence), incidence of pneumonia (RR 0.70, 95% CI 0.43 to 1.13; heterogeneity not applicable; very low-certainty evidence), length of hospital stay (MD -1.53 days, 95% CI -4.47 to 1.40; I² = 0%; very low-certainty evidence), and incidence of vomiting (RR 1.47, 95% CI 1.13 to 1.93; I² = 0%; very low-certainty evidence). One study (322 participants) assessed the impact of GRV threshold (500 mL per six hours) on clinical outcomes. The evidence is very uncertain about the effect of the threshold for GRV at time of aspiration on mortality rate (RR 1.01, 95% CI 0.74 to 1.38; heterogeneity not applicable; very low-certainty evidence), incidence of pneumonia (RR 1.03, 95% CI 0.72 to 1.46; heterogeneity not applicable; very low-certainty evidence), and length of hospital stay (MD -0.90 days, 95% CI -2.60 to 4.40; heterogeneity not applicable; very low-certainty evidence). Two studies (140 participants) explored the effects of returning or discarding the aspirated/drained GRV. The evidence is uncertain about the effect of discarding or returning the aspirated/drained GRV on the incidence of vomiting (RR 1.00, 95% CI 0.06 to 15.63; heterogeneity not applicable; very low-certainty evidence) and volume aspirated from the stomach (MD -7.30 mL, 95% CI -26.67 to 12.06, I² = 0%; very low-certainty evidence) We found no studies comparing the effects of protocol-based EN strategies that included GRV-related criteria against strategies that did not include such criteria. AUTHORS' CONCLUSIONS: The evidence is very uncertain about the effect of GRV on clinical outcomes including mortality, pneumonia, vomiting, and length of hospital stay.