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Quantitative Benefit-Risk Models Used for Rotavirus Vaccination: A Systematic Review.

ABSTRACT: Background:Although rotavirus vaccines have proven to prevent the risk of rotavirus gastroenteritis (RVGE) in children under 5 years old, they are also associated with an increased transient risk of intussusception (IS). Several quantitative benefit-risk models (qBRm) are performed to measure this balance in hospitalizations and deaths prevented versus the ones induced. Method:In this study, our objective was to provide a complete overview of qBRm used for rotavirus vaccination. We systematically searched 3 medical literature databases to identify relevant articles, in English, that were published between 2006 and 2019. Results:Of the 276 publications screened, 14 studies using qBRm for rotavirus vaccination were retained, based on preselected criteria. Four were performed in low- and middle-income countries. Almost all (13 of 14) displayed the following characteristics: force of infection assumed to be constant over time (static model), indirect effect of rotavirus vaccination (herd effect) not considered, closed model (individuals not allowed to enter and/or exit the model over time), and aggregated level (no tracking of individual's behavior). Most of the models were probabilistic (9 of 14) and reported sensitivity and/or scenario analyses (12 of 14). Input parameter values varied across studies. Selected studies suggest that, depending on the models used, for every IS hospitalization and death induced, vaccination would prevent, respectively, 190-1624 and 71-743 RVGE-related hospitalizations and deaths. Conclusions:The benefits of rotavirus vaccination were shown to largely exceed the increased risk of IS, across all studies. Future research aiming to harmonize qBRm for rotavirus vaccination should ensure the comparability of studies and provide additional information for regulatory authorities, physicians, and patients.

SUBMITTER: Arlegui H

PROVIDER: S-EPMC7148003 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Quantitative Benefit-Risk Models Used for Rotavirus Vaccination: A Systematic Review.

Arlegui Hugo H Nachbaur Gaëlle G Praet Nicolas N Bégaud Bernard B

Open forum infectious diseases 20200312 4

<h4>Background</h4>Although rotavirus vaccines have proven to prevent the risk of rotavirus gastroenteritis (RVGE) in children under 5 years old, they are also associated with an increased transient risk of intussusception (IS). Several quantitative benefit-risk models (qBRm) are performed to measure this balance in hospitalizations and deaths prevented versus the ones induced.<h4>Method</h4>In this study, our objective was to provide a complete overview of qBRm used for rotavirus vaccination. W ...[more]

PMID: 32296726

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Project description:IntroductionUnderstanding the balance between the benefits and risks of vaccination is essential to ensure informed and adequate public health decision making. Quantitative benefit-risk models (qBRm) represent useful tools to help decision makers with supporting benefit-risk assessment throughout the lifecycle of a medical product. However, few initiatives have been launched to harmonise qBRm approaches, specifically for vaccines.ObjectivesThe aim of this paper was to identify publications about qBRm applied to vaccines through a systematic literature review, and to describe their characteristics.MethodsMedline, Scopus and Institute for Scientific Information Web of Knowledge databases were searched to identify articles in English, published from database inceptions up to December 2019. The search strategy included the combination of three key concepts: 'benefit-risk', 'modelling' and 'vaccines'. Data extracted included the modelling context and the methodological approaches used.ResultsOf 3172 publications screened, 48 original publications were included. Most of the selected studies were published over the past decade and focused on rotavirus (15), dengue (10) and influenza (6) vaccines. The majority (30) of studies reported analyses related to high-income countries. The methodology of the studies differed, particularly in modelling techniques, benefit-risk measures, and sensitivity analyses. The present work also pointed out a high level of variability in the quality of reporting across studies, with particular regard to input parameters and methodological approaches.ConclusionsThis review provides an extensive list of qBRm applied to vaccines. Discrepancies across studies were identified during our review. While the number of published qBRm studies is increasing, no reporting guidance for qBRm applied to vaccines is currently available. This may affect decision makers' confidence in the results and their benefit-risk assessment(s); therefore, the development of such reporting guidance is highly needed.

Project description:Importance:The conclusions from the multiple randomized clinical trials exploring the relationship between development of intussusception and rotavirus vaccination among neonates and infants have been controversial. Objective:To evaluate the association between rotavirus vaccination and risk of intussusception. Data Sources:For this systematic review and meta-analysis, PubMed, Web of Science, Cochrane library, and Embase databases were searched from January 1, 1999, through December 31, 2018, using no language restrictions. The search terms were rotavirus or RV (rotavirus vaccine) or HRV (human rotavirus vaccine), vaccin*, and intussusception. Study Selection:Randomized clinical trials of neonates and infants that compared the risk of intussusception after the vaccination with a placebo group were included. Data Extraction and Synthesis:A fixed-effects model was used to pool the data. Statistical heterogeneity was assessed with Q test and I2 statistic; relative risk (RR), risk difference (RD), and 95% CIs were calculated using the Mantel-Haenszel method. Main Outcomes and Measures:The main outcome was the diagnosis of intussusception in the analysis. The pooled and subtotal results of RR, RD, and 95% CI for the risk of intussusception were estimated at 31 days, 1 year, and 2 years after vaccination. Results:A total of 25 randomized clinical trials including 200?594 participants (104?647 receiving vaccine and 95?947 receiving placebo) in 33 countries from 4 continents were included in this meta-analysis. Twenty cases of definite intussusception were diagnosed within 31 days after rotavirus vaccination, with 11 cases (55%) in the vaccine group and 9 cases (45%) in the placebo group (RD, 0.17 per 10?000 infants [95% CI, -1.16 to 1.50 per 10?000 infants], P?=?.80; RR, 1.14 [95% CI, 0.49 to 2.64], P?=?.77). Seventy-four cases were reported within 1 year, with 37 cases (50%) in the vaccine group and 37 cases (50%) in the placebo group (RD, -0.65 per 10?000 infants [95% CI, -2.68 to 1.39 per 10?000 infants], P?=?.53; RR, 0.84 [95% CI, 0.53 to 1.32], P?=?.45). Fifty-nine cases were reported within 2 years, with 29 cases (49%) in the vaccine group and 30 cases (51%) in the placebo group (RD, -0.48 per 10?000 infants [95% CI, -3.64 to 2.69 per 10?000 infants], P?=?.77; RR, 0.91 [95% CI, 0.55 to 1.52], P?=?.73). Conclusions and Relevance:Results of this systematic review and meta-analysis suggest that monovalent, pentavalent, monovalent human-bovine, oral bovine pentavalent, and human neonatal rotavirus vaccination was not associated with an elevated risk of intussusception among neonates or infants.

Project description:BACKGROUND AND OBJECTIVE:Since 2013, a biennial rotavirus pattern has emerged in the Netherlands with alternating high and low endemic years and a nearly 50% reduction in rotavirus hospitalization rates overall, while infant rotavirus vaccination has remained below 1% throughout. As the rotavirus vaccination cost-effectiveness and risk-benefit ratio in high-income settings is highly influenced by the total rotavirus disease burden, we re-evaluated two infant vaccination strategies, taking into account this recent change in rotavirus epidemiology. METHODS:We used updated rotavirus disease burden estimates derived from (active) surveillance to evaluate (1) a targeted strategy with selective vaccination of infants with medical risk conditions (prematurity, low birth weight, or congenital conditions) and (2) universal vaccination including all infants. In addition, we added herd protection as well as vaccine-induced intussusception risk to our previous cost-effectiveness model. An age- and risk-group structured, discrete-time event, stochastic multi-cohort model of the Dutch pediatric population was used to estimate the costs and effects of each vaccination strategy. RESULTS:The targeted vaccination was cost-saving under all scenarios tested from both the healthcare payer and societal perspective at rotavirus vaccine market prices (€135/child). The cost-effectiveness ratio for universal vaccination was €51,277 at the assumed vaccine price of €75/child, using a societal perspective and 3% discount rates. Universal vaccination became cost-neutral at €32/child. At an assumed vaccine-induced intussusception rate of 1/50,000, an estimated 1707 hospitalizations and 21 fatal rotavirus cases were averted by targeted vaccination per vaccine-induced intussusception case. Applying universal vaccination, an additional 571 hospitalizations and?<? 1 additional rotavirus death were averted in healthy children per vaccine-induced intussusception case. CONCLUSION:While universal infant rotavirus vaccination results in the highest reductions in the population burden of rotavirus, targeted vaccination should be considered as a cost-saving alternative with a favorable risk-benefit ratio for high-income settings where universal implementation is unfeasible because of budget restrictions, low rotavirus endemicity, and/or public acceptance.

Project description:ObjectivePeripheral nerve repair is required after traumatic injury. This common condition represents a major public health problem worldwide. Recovery after nerve repair depends on several factors, including the severity of the injury, the nerve involved, and the surgeon's technical skills. Despite the precise microsurgical repair of nerve lesions, adequate functional recovery is not always achieved and, therefore, the regeneration process and surgical techniques are still being studied. Pre-clinical animal models are essential for this research and, for this reason, the focus of the present systematic review (according to the PRISMA statement) was to analyze the different animal models used in pre-clinical peripheral nerve repair studies.Data sourcesOriginal articles, published in English from 2000 to 2018, were collected using the Web of Science, Scopus, and PubMed databases.Data selectionOnly preclinical trials on direct nerve repair were included in this review. The articles were evaluated by the first two authors, in accordance with predefined data fields.Outcome measuresThe primary outcomes included functional motor abilities, daily activity and regeneration rate. Secondary outcomes included coaptation technique and animal model.ResultsThis review yielded 267 articles, of which, after completion of the screening, 49 studies were analyzed. There were 1425 animals in those 49 studies, being rats, mice, guinea pigs, rabbits, cats and dogs the different pre-clinical models. The nerves used were classified into three groups: head and neck (11), forelimb (8) and hindlimb (30). The techniques used to perform the coaptation were: microsuture (46), glue (12), laser (8) and mechanical (2). The follow-up examinations were histology (43), electrophysiological analysis (24) and behavioral observation (22).ConclusionThe most widely used animal model in the study of peripheral nerve repair is the rat. Other animal models are also used but the cost-benefit of the rat model provides several strengths over the others. Suture techniques are currently the first option for nerve repair, but the use of glues, lasers and bioengineering materials is increasing. Hence, further research in this field is required to improve clinical practice.

Dataset Information

Quantitative Benefit-Risk Models Used for Rotavirus Vaccination: A Systematic Review.

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Quantitative Benefit-Risk Models Used for Rotavirus Vaccination: A Systematic Review.

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