| ```markdown | |
| Goal/Experiment: | |
| In this protocol for a systematic review, we aim to collect and analyze data on the clinical burden of RSV in Italian adults with the goal of informing and supporting National and local decision makers on the planification and implementation of future vaccination strategies. | |
| # Burden of RSV in Italian adults: Protocol for a Systematic Review and Meta-Analysis | |
| **Authors:** | |
| Giovanna Elisa, Alexander Domnich¹, Calabrò² | |
| ¹IRCCS Ospedale Policlinico San Martino; | |
| ²Section of Hygiene, Department of Life Sciences and Public Health, Università Cattolica del Sacro Cuore, Rome, Italy | |
| ## Abstract | |
| Globally, respiratory syncytial virus (RSV) is a leading cause of respiratory infections and is responsible for a significant socioeconomic burden in all age groups, including adults. To date, no review systematically appraised the burden of RSV in Italian adults. Understanding country-specific burden of disease is a key driver for policy decisions on the introduction of new vaccines. Two vaccines have been recently authorized to prevent lower respiratory tract disease caused by RSV in adults. In this protocol for a systematic review, we aim to collect and analyze data on the clinical burden of RSV in Italian adults with the goal of informing and supporting National and local decision makers on the planification and implementation of future vaccination strategies. | |
| ## Introduction | |
| Together with seasonal influenza, respiratory syncytial virus (RSV) is a leading cause of respiratory infections and is responsible for a significant socioeconomic burden in all age groups, especially at the extremes of age. | |
| ### Country-Specific Burden of Disease (BoD) | |
| Recent studies have estimated that a significant number of RSV-associated hospitalizations among European adults occur annually, primarily affecting older adults aged ≥ 65 years. In the last 20 years, mortality attributable to RSV has increased among working-age and older adults. | |
| ### Existing Research | |
| Multiple systematic reviews have confirmed significant RSV attack rates, hospitalization, mortality, and case-fatality rates globally, although there is a substantial under-ascertainment. Available reviews have identified only up to six primary studies conducted in Italy. | |
| ### Vaccines | |
| Two vaccines have been recently authorized to prevent lower respiratory tract disease (LRTD) caused by RSV in adults aged ≥ 60 years. In the UK, vaccination is recommended for older adults aged ≥ 75 years. | |
| ### Importance of Country-Specific BoD Indicators | |
| Understanding country-specific BoD indicators is crucial for policy making and efficient implementation of new vaccines. | |
| ## Methods | |
| ### Reporting Standards | |
| - The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement will be adopted. | |
| - Methodological guidance from the Joanna Briggs Institute (JBI) will be consulted. | |
| ### Eligibility Criteria | |
| - **Types of Studies:** Observational studies (e.g., surveillance, cross-sectional, cohort, case-series) in any modality. | |
| - **Condition of Interest:** RSV infection detected by laboratory techniques such as RT-PCR, immunofluorescence assay (IFA), cell culture, and RADT. | |
| - **Context:** Studies conducted in Italy, in any setting and calendar period. | |
| - **Population:** Adults defined as individuals aged ≥ 14/18 years. | |
| ### Exclusion Criteria | |
| - Modeling studies, pharmacoeconomic studies, studies with no original data, general population studies with no separate data for adults, and multi-country studies with no separate information for Italy. | |
| ### Study Endpoints | |
| - **RSV Attack Rate:** Cumulative incidence of laboratory-confirmed RSV detections. | |
| - **RSV Prevalence:** Proportion of RSV detections to the total number of subjects tested. | |
| - **Case Complication Rate:** Proportion of RSV-positive individuals with complications. | |
| - **Drug Use Indicators:** Frequency of drug prescriptions among RSV-positive subjects. | |
| - **Hospitalization Metrics:** Crude hospitalization rates, ICU admissions, in-hospital mortality, and case-fatality rates. | |
| ### Search Strategy | |
| The automatic search will be performed in databases such as PubMed/Medline, Biological Abstracts, and Scopus, and will follow a specific search script. A manual search and cross-referencing will also be conducted. | |
| ### Study Selection | |
| Records from the automatic search will be merged into a spreadsheet, and duplicates will be removed. Titles and abstracts will be screened, and full texts of potentially relevant studies will be assessed for eligibility. | |
| ### Data Extraction and Coding | |
| Data extracted will include: | |
| - Full citation record | |
| - Location and period of study | |
| - Study design and setting | |
| - Population and sample size | |
| - RSV case ascertainment methods | |
| - Endpoints of interest | |
| - Handling of missing data | |
| ### Critical Appraisal | |
| The JBI checklist for prevalence/incidence studies will be used to assess the quality of included studies. Appraisals will be performed independently by two reviewers. | |
| ### Data Synthesis | |
| Data will be qualitatively appraised and visualized using forest plots. Quantitative synthesis will involve proportional meta-analysis using the R package "Meta" v. 6.5-0. Heterogeneity will be quantified using I² statistics. | |
| ## Attachments | |
| - Prot_SRMA_RSV_Ita_v131_12013.pdf | |
| endofoutput | |
| ``` | |