Scoping review of costs of implementation strategies in community, public health and healthcare settings

Objectives
To identify existing evidence concerning the cost of dissemination and implementation (D&I) strategies in community, public health and health service research, mapped with the ‘Expert Recommendations for Implementing Change’ (ERIC) taxonomy.

Design
Scoping review.

Data sources
MEDLINE, EMBASE, CINAHL, PsycINFO, Scopus and the Cochrane Library were searched to identify any English language reports that had been published between January 2008 and December 2019 concerning the cost of D&I strategies.

Data extraction
We matched the strategies identified in each article using ERIC taxonomies; further classified them into five areas (eg, dissemination, implementation, integration, capacity building and scale-up); and extracted the corresponding costs (total costs and cots per action target and per evidence-based programme (EBP) participant). We also recorded the reported level of costing methodology used for cost assessment of D&I strategies.

Results
Of the 6445 articles identified, 52 studies were eligible for data extraction. Lack of D&I strategy cost data was the predominant reason (55% of the excluded studies) for study exclusion. Predominant topic, setting, country and research design in the included studies were mental health (19%), primary care settings (44%), the US (35%) and observational (42%). Thirty-five (67%) studies used multicomponent D&I strategies (ranging from two to five discrete strategies). The most frequently applied strategies were Conduct ongoing training (50%) and Conduct educational meetings (23%). Adoption (42%) and reach (27%) were the two most frequently assessed outcomes. The overall costs of Conduct ongoing training ranged from $199 to $105 772 ($1–$13 973 per action target and $0.02–$412 per EBP participant); whereas the cost of Conduct educational meetings ranged from $987 to $1.1–$2.9 million/year ($33–$54 869 per action target and $0.2–$146 per EBP participant). The wide range of costs was due to the varying scales of the studies, intended audiences/diseases and the complexities of the strategy components. Most studies presented limited information on costing methodology, making interpretation difficult.

Conclusions
The quantity of published D&I strategy cost analyses is increasing, yet guidance on conducting and reporting of D&I strategy cost analysis is necessary to facilitate and promote the application of comparative economic evaluation in the field of D&I research.

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Giugno 2022

The relationship between the living lab approach and successful implementation of healthcare innovations: an integrative review

Objectives
The concept of living labs as a research method to enhance participation of end-users in the development and implementation process of an innovation, gained increasing attention over the past decade. A living lab can be characterised by five key components: user-centric, cocreation, real-life context, test innovation and open innovation. The purpose of this integrative literature review was to summarise the literature on the relationship between the living lab approach and successful implementation of healthcare innovations.

Methods
An integrative literature review searching PubMed, EMBASE, PsycINFO and Cinahl databases between January 2000 and December 2019. Studies were included when a living lab approach was used to implement innovations in healthcare and implementation outcomes were reported. Included studies evaluated at least one of the following implementation outcomes: acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration or sustainability. Quality was assessed based on a tool developed by Hawker et al.

Results
Of the 1173 retrieved articles, 30 studies were included of which 11 of high quality. Most studies involved a combination of patients/public (N=23) and providers (N=17) as key stakeholders in the living lab approach. Living lab components were mostly applied in the development phase of innovations (N=21). The majority of studies reported on achievement of acceptability (N=22) and feasibility (N=17) in terms of implementation outcomes. A broader spectrum of implementation outcomes was only evaluated in one study. We found that in particular six success factors were mentioned for the added-value of using living lab components for healthcare innovations: leadership, involvement, timing, openness, organisational support and ownership.

Conclusions
The living lab approach showed to contribute to successful implementation outcomes. This integrative review suggests that using a living lab approach fosters collaboration and participation in the development and implementation of new healthcare innovations.

PROSPERO registration number
CRD42020166895.

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Giugno 2022

Estimating the global health impact of gender-based violence and violence against children: a systematic review and meta-analysis protocol

Introduction
Exposure to gender-based violence (GBV) and violence against children (VAC) can result in substantial morbidity and mortality. Previous reviews of health outcomes associated with GBV and VAC have focused on limited definitions of exposure to violence (ie, intimate partner violence) and often investigate associations only with predefined health outcomes. In this protocol, we describe a systematic review and meta-analysis for a comprehensive assessment of the impact of violence exposure on health outcomes and health-related risk factors across the life-course.

Methods and analysis
Electronic databases (PubMed, Embase, CINAHL, PsycINFO, Global Index Medicus, Cochrane and Web of Science Core Collection) will be searched from 1 January 1970 to 30 September 2021 and searches updated to the current date prior to final preparation of results. Reviewers will first screen titles and abstracts, and eligible articles will then be full-text screened and accepted should they meet all inclusion criteria. Data will be extracted using a standardised form with fields to capture study characteristics and estimates of association between violence exposure and health outcomes. Individual study quality will be assessed via six risk of bias criteria. For exposure–outcome pairs with sufficient data, evidence will be synthesised via a meta-regression—Bayesian, regularised, trimmed model and confidence in the cumulative evidence assessed via the burden of proof risk function. Where possible, variations in associations by subgroup, that is, age, sex or gender, will be explored.

Ethics and dissemination
Formal ethical approval is not required. Findings from this review will be used to inform improved estimation of GBV and VAC within the Global Burden of Disease Study. The review has been undertaken in conjunction with the Lancet Commission on GBV and the Maltreatment of Young People with the aim of providing new data insights for a report on the global response to violence.

PROSPERO registration number
CRD42022299831.

Leggi
Giugno 2022

Examining anti-inflammatory therapies in the prevention of cardiovascular events: protocol for a systematic review and network meta-analysis of randomised controlled trials

Introduction
Inflammation is emerging as an important risk factor for atherosclerotic cardiovascular disease and has been a recent target for many novel therapeutic agents. However, comparative evidence regarding efficacy of these anti-inflammatory treatment options is currently lacking.

Methods and analysis
This systematic review will include randomised controlled trials evaluating the effect of anti-inflammatory agents on cardiovascular outcomes in patients with known cardiovascular disease. Studies will be retrieved from Medline, Embase, the Cochrane Central Register of Controlled Trials, as well as clinical trial registry websites, Europe PMC and conference abstract handsearching. No publication date or language restrictions will be imposed. Eligible interventions must have some component of anti-inflammatory agent. These include (but are not limited to): non-steroidal anti-inflammatory drugs (NSAIDs), colchicine, prednisone, methotrexate, canakinumab, pexelizumab, anakinra, succinobucol, losmapimod, inclacumab, atreleuton, LP-PLA2 (darapladib) and sPLA2 (varespladib). The primary outcomes will include major adverse cardiac events (MACE), and each individual component of MACE (myocardial infarction, stroke and cardiovascular death). Key secondary outcomes will include unstable angina, heart failure, all-cause mortality, cardiac arrest and revascularisation. Screening, inclusion, data extraction and quality assessment will be performed independently by two reviewers. Network meta-analysis based on the random effects model will be conducted to compare treatment effects both directly and indirectly. The quality of the evidence will be assessed with appropriate tools including the Grading of Recommendations, Assessment, Development and Evaluation profiler or Confidence in Network Meta-Analysis tool.

Ethics and dissemination
Ethics approval is not required for this systematic review. The findings will be disseminated through a peer-reviewed journal.

PROSPERO registration number
CRD42022303289.

Leggi
Giugno 2022

Minimal clinical data sets for spine-related musculoskeletal disorders in primary care and outpatient settings: a scoping review protocol

Introduction
Lack of standardised clinical data collection may lead to reduced quality in musculoskeletal (MSK)-related clinical care and research. Little is known about the availability and characteristics of minimal clinical data sets for spine-related MSK disorders in primary care and outpatient settings and their utility for improving healthcare quality. Our objective is to undertake a scoping review aiming to identify and map current literature on minimal clinical data sets for measuring and monitoring health status in patients with spine-related MSK disorders in primary and outpatient healthcare settings.

Methods and analysis
The 2020 Joanna Briggs Institute methodology for scoping reviews will guide review conduct. The review will consider studies that describe and report on minimal clinical data sets for spine-related MSK disorders designed for primary care and outpatient clinical practice settings. Quantitative and qualitative study designs will be eligible, including consensus-based studies, interventional, observational, feasibility and linguistic validation studies. Studies published in English, German, French, Italian and Spanish will be included, with no limit on date of publication. MEDLINE, CINAHL, Cochrane Library, Index to Chiropractic Literature, MANTIS, ProQuest Dissertations & Theses Global and medRxiv preprint repository will be searched from database inception to 25 July 2021. Two reviewers will independently screen identified titles, abstracts and relevant full-text records, and then extract data using review-specific data extraction forms. Findings will be synthesised and presented as a descriptive summary using PRISMA ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews).

Ethics and dissemination
Ethics review and approval is not required for this scoping review. Our target audience for this review will be clinicians, researchers, patients and other relevant stakeholders involved in the measurement and health status monitoring of patients with spine-related MSK disorders. Results will be shared through peer-reviewed publication and presentations at relevant conferences.

Protocol registration number
https://osf.io/fkw5b.

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Giugno 2022

Shorter versus longer durations of antibiotic treatment for patients with community-acquired pneumonia: a protocol for a systematic review and meta-analysis

Introduction
Community-acquired pneumonia (CAP), frequently encountered in both outpatient and inpatient settings, is the leading cause of infectious disease-related mortality. While equipoise regarding the optimal duration of antimicrobial therapy to treat CAP remains, recent studies suggest shorter durations of therapy may achieve optimal outcomes. We have therefore planned a systematic review and meta-analysis evaluating the impact of shorter versus longer durations of antibiotic therapy for patients with CAP.

Methods and analysis
We searched Ovid MEDLINE, Embase, CINAHL and Cochrane Central Register of Controlled Trials from inception to September 2021 for randomised controlled trials evaluating shorter versus longer duration of antibiotics. Eligible studies will compare durations with a minimum difference of two days of antibiotic therapy, irrespective of antibiotic agent, class, route, frequency or dosage, and will report on any patient-important outcome of benefit or harm. Paired reviewers working independently will conduct title and abstract screening, full-text screening, data extraction and risk of bias (RoB) evaluation using a modified Cochrane RoB 2.0 tool. We will perform random-effects modelling for meta-analyses, with study weights generated using the inverse variance method, and will assess certainty in effect estimates using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. The Instrument for assessing the Credibility of Effect Modification Analyses (ICEMAN) tool will inform assessments of credibility of subgroup effects based on severity of illness, drug class, duration of therapy, setting of CAP acquisition and RoB.

Ethics and dissemination
The results will be of importance to general practitioners and internists managing CAP, and may directly inform international clinical guidance. Where concerns regarding antimicrobial resistance continue to grow internationally, this evidence summary may motivate new recommendations regarding shorter durations of therapy. We intend to disseminate our findings via national and international conferences, and publication in a peer-reviewed journal.

PROSPERO registration number
CRD42021283990.

Leggi
Giugno 2022

Psychometric properties of self-reported financial toxicity measures in cancer survivors: a systematic review

Objective
The aim of this systematic review was to summarise the psychometric properties of patient-reported outcome measures (PROMs) measuring financial toxicity (FT) in cancer survivors.

Design
This systematic review was conducted according to the guidance of the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) methodology.

Data sources
Comprehensive searches were performed in PubMed, MEDLINE, Embase, CINAHL, PsycINFO, Web of Science, ProQuest and Cochrane Library from database inception to February 2022.

Eligibility criteria for selecting studies
We included studies that reported any PROMs for measuring FT in cancer survivors who were ≥18 years old. FT was defined as perceived subjective financial distress resulting from objective financial burden. Studies that were not validation studies and that used a PROM only as an outcome measurement were excluded.

Data extraction and synthesis
Two reviewers independently extracted data from the included papers. We used the COSMIN criteria to summarise and evaluate the psychometric properties of each study regarding structural validity, internal consistency, reliability, measurement error, hypothesis testing for construct validity, cross-cultural validity/measurement invariance, criterion validity and responsiveness.

Results
A total of 23 articles (21 PROMs) were eligible for inclusion in this study. The findings highlighted that the Comprehensive Score for Financial Toxicity (COST) had an adequate development process and showed better psychometric properties than other PROMs, especially in internal consistency (Cronbach’s α=0.92), reliability (intraclass correlation coefficient=0.80) and hypothesis testing (r=0.42–0.20).

Conclusions
From a psychometric property perspective, the COST could be recommended as the most suitable worldwide available measure for use in research and clinical practice across different contexts. We suggest that PROMs should be selected only after careful consideration of the local socioeconomic context. Future studies are warranted to develop various FT PROMs based on different social and cultural backgrounds and to clarify the theoretical grounds for assessing FT.

Leggi
Giugno 2022

Upstream interventions to promote oral health and reduce socioeconomic oral health inequalities: a scoping review protocol

Introduction
Improving oral health and reducing oral health inequalities is an important global health priority. ‘Upstream interventions’ are a vital part of the collective effort to reduce oral disease burdens, however it is a rather nebulous term. Furthermore, there is little evidence on the effectiveness, impact and sustainability of upstream interventions that have focused on oral health and wider public health measures that impact on oral health. The aim of this scoping review is to systematically map and synthesise evidence on the effectiveness, impact and sustainability of upstream interventions on population oral health and reducing socioeconomic oral health inequalities.

Methods and analysis
This scoping review will be conducted in accordance with the Joanna Briggs Institute methodology and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews checklist. A detailed search strategy will be used to conduct a comprehensive search of electronic databases: Scopus, Embase and MEDLINE, PsycINFO and CINAHL, ASSIA and Cochrane Database of Systematic Reviews. A search of grey literature will also be completed to identify relevant dissertations, governmental reports and evaluations of implemented policies. Identification and extraction of data will be performed by two pairs of reviewers. Oversight and feedback will be provided by an independent expert advisory group.

Ethics and dissemination
This study will review published and available grey literature and does not require an ethics review. The scoping review protocol has been registered with the Open Science Framework. The final report will be circulated and disseminated through publication and feed into the work of the ongoing Lancet Commission on Oral Health. Due to the policy relevance of this work, discussions will take place with key stakeholders regarding the implications of the findings for future policy development.

Leggi
Giugno 2022

Current knowledge on spinal meningiomas: a systematic review protocol

Introduction
Meningiomas are primary central nervous system tumours that arise from both cranial and spinal meninges. Spinal meningiomas occur less frequently than their cranial counterparts and are consequently given less attention in the literature. Therefore, systematic studies are needed to summarise the current knowledge on spinal meningiomas, providing a solid evidence base for treatment strategies. This systematic review of the literature will therefore assess studies describing spinal meningiomas, their epidemiology, diagnostics, treatment and outcomes.

Methods and analysis
Electronic databases, including PubMed, Web of Science and Embase, will be searched using the keywords “spinal” and “meningioma”. The search will be set to provide only English studies published after 2000 to avoid any conflicts regarding terminology and classification, as well as to reflect the current status. Case reports, editorials, letters and reviews will also be excluded. Reference lists of relevant records will also be searched. Identified studies will be screened for inclusion, by one reviewer in a first step and then three in the next step to decrease the risk of bias. The results will be categorised to allow for a structured summary of the outcomes and their evidence grade conforming to the Grading of Recommendations, Assessment, Development and Evaluation approach. Categories may include: epidemiology, histopathology, radiological diagnostics, surgery, complications, non-surgical or adjuvant treatments, disease outcomes and predictors, and lastly recurrence. This review will summarise the current knowledge on spinal meningiomas to allow for a better understanding of the disease and contribute to improve its management. For clinicians, the systematic collection and grading of available evidence may aid in decision making and for those seeking to further the scientific field, this review may help to identify areas where knowledge is currently lacking.

Ethics and dissemination
Ethics approval was not required for our systematic review as it is based on existing publications. The results will be disseminated via submission for publication in a peer-reviewed journal.

Leggi
Giugno 2022

Aluminium adjuvants versus placebo or no intervention in vaccine randomised clinical trials: a systematic review with meta-analysis and Trial Sequential Analysis

Objectives
To assess the benefits and harms of aluminium adjuvants versus placebo or no intervention in randomised clinical trials in relation to human vaccine development.

Design
Systematic review with meta-analysis and trial sequential analysis assessing the certainty of evidence with Grading of Recommendations Assessment, Development and Evaluation (GRADE).

Data sources
We searched CENTRAL, MEDLINE, Embase, LILACS, BIOSIS, Science Citation Index Expanded and Conference Proceedings Citation Index-Science until 29 June 2021, and Chinese databases until September 2021.

Eligibility criteria
Randomised clinical trials irrespective of type, status and language of publication, with trial participants of any sex, age, ethnicity, diagnosis, comorbidity and country of residence.

Data extraction and synthesis
Two independent reviewers extracted data and assessed risk of bias with Cochrane’s RoB tool 1. Dichotomous data were analysed as risk ratios (RRs) and continuous data as mean differences. We explored both fixed-effect and random-effects models, with 95% CI. Heterogeneity was quantified with I2 statistic. We GRADE assessed the certainty of the evidence.

Results
We included 102 randomised clinical trials (26 457 participants). Aluminium adjuvants versus placebo or no intervention may have no effect on serious adverse events (RR 1.18, 95% CI 0.97 to 1.43; very low certainty) and on all-cause mortality (RR 1.02, 95% CI 0.74 to 1.41; very low certainty). No trial reported on quality of life. Aluminium adjuvants versus placebo or no intervention may increase adverse events (RR 1.13, 95% CI 1.07 to 1.20; very low certainty). We found no or little evidence of a difference between aluminium adjuvants versus placebo or no intervention when assessing serology with geometric mean titres or concentrations or participants’ seroprotection.

Conclusions
Based on evidence at very low certainty, we were unable to identify benefits of aluminium adjuvants, which may be associated with adverse events considered non-serious.

Leggi
Giugno 2022

Laparoscopic versus open left hemicolectomy for left-sided colon cancer: protocol for a systematic review and meta-analysis

Introduction
Laparoscopic colectomy has been widely used clinically due to its minimally invasive advantages, and many studies have also demonstrated its safety and efficacy. However, the efficacy of laparoscopic left hemicolectomy remains unclear due to the differences in pathogenesis and surgical details between left and right colon cancers. Therefore, we plan to conduct a systematic review and meta-analysis to investigate whether laparoscopic techniques can be safely used in left hemicolectomy.

Method and analysis
This meta-analysis protocol will be completed and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. A systematic search was performed for all articles related to laparoscopic left hemicolectomy in PubMed, Web of Science, Medline, EMBASE and the Cochrane Library from inception to 5 November 2021. Article screening and data extraction were performed independently by two authors and cross-checked after completion. The literature to be included will use corresponding tools for bias risk assessment. Subgroup analyses and sensitivity analyses will be used to explore potential heterogeneity.

Ethics and dissemination
Because this systematic review is based on studies with published results and does not involve intervention in patients, no ethical review is required. The results of this study will be published in a peer-reviewed journal.

PROSPERO registration number
CRD42022291526.

Leggi
Giugno 2022

Psychological interventions for inflammatory bowel disease: a systematic review and component network meta-analysis protocol

Introduction
Patients with inflammatory bowel diseases (IBD) often report psychological problems, unemployment, disability, sick leave and compromised quality of life. The effect of psychological interventions on health-related outcomes in IBD is controversial as previous reviews faced the obstacle of high heterogeneity among provided multimodular interventions. The heterogeneity can be addressed with network meta-analysis (NMA) and (multi)component NMA (CNMA). We aim to investigate whether psychological interventions can improve quality of life, clinical and social outcomes in IBD using NMA and CNMA. This is the study protocol.

Methods and analysis
We will consider randomised, quasi-randomised and non-randomised controlled trials, including cluster randomised and cross-over trials with 2 months of minimum follow-up. The conditions to be studied comprise Crohn’s disease and ulcerative colitis in children, adolescents and adults. We will include any psychological intervention aiming to change the health status of the study participant.
We will search Medline, Embase, Web of Science, CENTRAL, LILACS, Psyndex, PsycINFO, Google Scholar and trial registries from inception (the search will be updated before the review completion). Two authors will independently screen all references based on titles and abstracts. For data extraction, standard forms are developed and tested before extraction. All information will be assessed independently by at least two reviewers, and disagreements solved by consensus discussion or a third rater if necessary.
The data synthesis will include a pairwise meta-analysis supported by meta-regression. We will conduct NMA (all treatments will constitute single nodes of the network) and CNMA (we will define all treatments as sums of core components, eg, cognitive +behaviour, or cognitive +behaviour + relaxation, and additionally consider interactions) using the R Package netmeta.

Ethics and dissemination
No ethical approval is required. Reports will include the final report to the funder, conference presentation, peer-reviewed publication and a patient report.

PROSPERO registration number
CRD42021250446.

Leggi
Giugno 2022

Relationship between serum lipid level and colorectal cancer: a systemic review and meta-analysis

Objective
Investigative studies report contradictory results of the relationship between serum lipid levels and the risk of colorectal cancer (CRC). We conducted a meta-analysis of prospective published studies to clarify the relationship between serum lipid and CRC risk.

Design
Systematic review and meta-analysis.

Data Sources
PubMed and Embase from inception until December 2020.

Eligibility criteria
We considered prospective cohort and case–control studies that evaluated differences in serum lipid levels with the risk of developing CRC.

Data extraction and synthesis
Two independent reviewers screened and included the studies using standardised electronic data extraction forms. The relative risks of the studies were combined with random-effect and fixed-effect models and were analysed for heterogeneity, publication bias and sensitivity.

Results
Twenty-four prospective studies, including 4 224 317 individuals with 29 499 CRC cases, were included in the meta-analysis. The total pooled risk ratio (RR) for high vs low concentrations of triglyceride (TG) concentrations was reported at 1.21 (95% CI 1.09 to 1.34; I2=46.8%), total cholesterol (TC) was at 1.15 (95% CI 1.08 to 1.22; I2=36.8%), high-density lipoprotein cholesterol (HDL-C) was 0.86 (95% CI 0.77 to 0.97; I2=28.8%) and low-density lipoprotein cholesterol (LDL-C) was observed at 1.03 (95% CI 0.75 to 1.41; I2=69.4%).

Conclusions
This meta-analysis shows that high levels of serum TG and TC are positively correlated with the incidence rate of CRC, while high levels of serum HDL-C are negatively correlated with CRC incidence rate. Furthermore, no association was found between LDL-C and the risk of developing CRC. Nevertheless, the heterogeneity brought about by comparative methods, demographic differences and pathological differences between the research subjects limits the effectiveness of the overall pooled results.

Leggi
Giugno 2022

More than just staffing? Assessing evidence on the complex interplay among nurse staffing, other features of organisational context and resident outcomes in long-term care: a systematic review protocol

Introduction
Especially in acute care, evidence points to an association between care staffing and resident outcomes. However, this evidence is more limited in residential long-term care (LTC). Due to fundamental differences in the population of care recipients, organisational processes and staffing models, studies in acute care may not be applicable to LTC settings. We especially lack evidence on the complex interplay among nurse staffing and organisational context factors such as leadership, work culture or communication, and how these complex interactions influence resident outcomes. Our systematic review will identify and synthesise the available evidence on how nurse staffing and organisational context in residential LTC interact and how this impacts resident outcomes.

Methods and analysis
We will systematically search the databases MEDLINE, EMBASE, CINAHL, Scopus and PsycINFO from inception for quantitative research studies and systematically conducted reviews that statistically modelled interactions among nurse staffing and organisational context variables. We will include original studies that included nurse staffing and organisational context in LTC as independent variables, modelled interactions between these variables and described associations of these interactions with resident outcomes. Two reviewers will independently screen titles/abstracts and full texts for inclusion. They will also screen contents of key journals, publications of key authors and reference lists of all included studies. Discrepancies at any stage of the process will be resolved by consensus. Data extraction will be performed by one research team member and checked by a second team member. Two reviewers will independently assess the methodological quality of included studies using four validated checklists appropriate for different research designs. We will conduct a meta-analysis if pooling is possible. Otherwise, we will synthesise results using thematic analysis and vote counting.

Ethics and dissemination
Ethical approval is not required as this project does not involve primary data collection. The results of this study will be disseminated via peer-reviewed publications and conference presentation.

PROSPERO Registration number
CRD42021272671.

Leggi
Giugno 2022