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  • 1
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    Abatacept, Cenicriviroc, or Infliximab for Treatment of Adults Hospitalized With COVID-19 Pneumonia : A Randomized Clinical Trial
    American Medical Association (AMA) ; 2023
    In:  JAMA Vol. 330, No. 4 ( 2023-07-25), p. 328-
    Details
    In: JAMA, American Medical Association (AMA), Vol. 330, No. 4 ( 2023-07-25), p. 328-
    Abstract: Immune dysregulation contributes to poorer outcomes in COVID-19. Objective To investigate whether abatacept, cenicriviroc, or infliximab provides benefit when added to standard care for COVID-19 pneumonia. Design, Setting, and Participants Randomized, double-masked, placebo-controlled clinical trial using a master protocol to investigate immunomodulators added to standard care for treatment of participants hospitalized with COVID-19 pneumonia. The results of 3 substudies are reported from 95 hospitals at 85 clinical research sites in the US and Latin America. Hospitalized patients 18 years or older with confirmed SARS-CoV-2 infection within 14 days and evidence of pulmonary involvement underwent randomization between October 2020 and December 2021. Interventions Single infusion of abatacept (10 mg/kg; maximum dose, 1000 mg) or infliximab (5 mg/kg) or a 28-day oral course of cenicriviroc (300-mg loading dose followed by 150 mg twice per day). Main Outcomes and Measures The primary outcome was time to recovery by day 28 evaluated using an 8-point ordinal scale (higher scores indicate better health). Recovery was defined as the first day the participant scored at least 6 on the ordinal scale. Results Of the 1971 participants randomized across the 3 substudies, the mean (SD) age was 54.8 (14.6) years and 1218 (61.8%) were men. The primary end point of time to recovery from COVID-19 pneumonia was not significantly different for abatacept (recovery rate ratio [RRR], 1.12 [95% CI, 0.98-1.28] ; P  = .09), cenicriviroc (RRR, 1.01 [95% CI, 0.86-1.18]; P  = .94), or infliximab (RRR, 1.12 [95% CI, 0.99-1.28]; P  = .08) compared with placebo. All-cause 28-day mortality was 11.0% for abatacept vs 15.1% for placebo (odds ratio [OR], 0.62 [95% CI, 0.41-0.94] ), 13.8% for cenicriviroc vs 11.9% for placebo (OR, 1.18 [95% CI 0.72-1.94]), and 10.1% for infliximab vs 14.5% for placebo (OR, 0.59 [95% CI, 0.39-0.90] ). Safety outcomes were comparable between active treatment and placebo, including secondary infections, in all 3 substudies. Conclusions and Relevance Time to recovery from COVID-19 pneumonia among hospitalized participants was not significantly different for abatacept, cenicriviroc, or infliximab vs placebo. Trial Registration ClinicalTrials.gov Identifier: NCT04593940
    Type of Medium: Online Resource
    ISSN: 0098-7484
    URL: Article
    DOI: 10.1001/jama.2023.11043
    RVK:
    XA 10000
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2023
    detail.hit.zdb_id: 2958-0
    detail.hit.zdb_id: 2018410-4
    SSG: 5,21
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  • 2
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    281. Not the sharpest of tools: Procalcitonin and bacterial co-infections in patients admitted with COVID-19
    Oxford University Press (OUP) ; 2022
    In:  Open Forum Infectious Diseases Vol. 9, No. Supplement_2 ( 2022-12-15)
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)
    Abstract: The COVID-19 pandemic has caused record breaking hospitalizations due to respiratory failure. A major challenge in the management of COVID-19 is the difficulty distinguishing COVID-19 from other causes of lower respiratory tract infections (LRTIs) that may require antimicrobial use (AU). Procalcitonin (PCT) has been used to differentiate viral from bacterial causes of LRTIs and clinicians have relied on PCT to use or withhold antimicrobials. However, the utility of PCT in the setting of COVID-19 remains unclear. We seek to define the role of PCT in patients admitted with COVID-19. Methods Retrospective cohort study of COVID-19 inpatients with PCT ordered at a 151-bed urban community hospital from March 2020-March 2022. Ranges of PCT were categorized as high ( & gt;5 µg/L), medium (0.25-5 µg/L), and low ( & lt; 0.25 µg/L) risk of infection. Co-infection was defined as presence of clinical and microbiological evidence of infection in blood (BSI) or in sputum within 7 days of admission. Late infections were excluded Results Of a total 262 cases, 154 (58%) were low-risk, 43 (16%) medium-risk, and 63 (24%) high-risk (Figure 1). AU in the low-risk category was 29% (45), followed by 29% in the moderate and 36% in high-risk categories. 1 BSI caused by Klebsiella pneumoniae in the low-risk category and 1 LRTI caused by Streptococcus pneumoniae in the high-risk category were found, representing 0.6% and 1.5% of samples in those categories. Total documented infection was 0.7% for all cases. Figure 1.Procalcitonin levels and co-infections in patients admitted with COVID-19 pneumonia. Conclusion PCT has limited utility in COVID-19. Co-infection rates on admission are exceedingly rare, representing & lt; 1% of our cohort. Only 2 documented infections were found, 1 of which was in the low-risk category. Thus, PCT was commonly elevated without documented infection. Though rare, a co-infection can occur without elevation of PCT. As described in the 2019 IDSA Community Acquired Pneumonia Guidelines, the use of PCT is of limited utility and may confound providers towards using or deferring antimicrobials inappropriately. This remains true in COVID-19. Antimicrobial stewardship programs should advise against its routine use. Disclosures All Authors: No reported disclosures.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofac492.359
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 3
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    1109. Rise and Fall of COVID-19 Therapies Throughout Different Waves of the Pandemic: Results of a Nationwide Survey
    Oxford University Press (OUP) ; 2022
    In:  Open Forum Infectious Diseases Vol. 9, No. Supplement_2 ( 2022-12-15)
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)
    Abstract: The COVID-19 pandemic has caused a major public health crisis and is now a leading cause of death. At the start of the COVID-19 pandemic, treatment was limited to supportive care and off-label use of a variety of agents as we awaited the results of randomized controlled trials (RCTs). Our understanding of the disease has evolved and multiple evidence-based (EBM) treatment strategies supported by RCTs are now approved for use. Interpreting emerging data while responding to the pandemic can been challenging. We seek to understand the use of common medications during the COVID-19 pandemic. Methods A survey was developed and disseminated through Infectious Diseases Society of America (IDSA) IDea network, IDSA Antimicrobial Stewardship Centers for Excellence and the Society for Healthcare Epidemiology messaging boards. Data collected included city, therapeutic options including convalescent plasma (CP), hydroxychloroquine (HCQ), baricitinib and tocilizumab during each COVID-19 wave. Results A total of 78 responses were collected, representing wide geographic reach in the US (Figure 1). Use of HCQ declined by 96% and use of CP declined by 85% (Figure 2). The decline in CP was gradual each wave despite RCTs showing lack of benefit. Tocilizumab was used in 71% and 76% of hospitals during the first wave, prior to RCT data supporting its use. Baricitinib was used in 42% of hospitals prior to RCT data supporting its use. There was a 90% increase in baricitinib use after RCT data emerged. Figure 1Geographic distribution of hospitals represented in the survey Figure 2 Use of Hydroxychloroquine, Convalescent Plasma, Tocilizumab and Baricitinib Throughout Different COVID-19 Waves Conclusion The use of therapies before proven benefit was common through the pandemic. Similarly, the use of therapies after benefit was in question continued. Hydroxychloroquine was widely used in the first wave and then halted by the majority of hospitals in subsequent COVID-19 surges. IL-6 and JAK-2 inhibitors were commonly used prior to evidence of benefit and were more widely adopted once evidence emerged. Convalescent plasma use was common despite lack of evidence and its use continued despite multiple negative RCTs. Overall, our survey shows a gap between evidence and practice. Communicating evidence-based treatment strategies is a vital priority for major professional societies. Translating evidence into practice remains challenging during public health emergencies like the COVID-19 pandemic. Disclosures All Authors: No reported disclosures.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofac492.948
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 4
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    1664. Impact of a Midline Catheter Prioritization Project on Central Venous Access and Central Line Associated Bloodstream Infections at an Urban Safety-net Community Hospital
    Oxford University Press (OUP) ; 2022
    In:  Open Forum Infectious Diseases Vol. 9, No. Supplement_2 ( 2022-12-15)
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)
    Abstract: The use of peripherally inserted central catheters (PICCs) has increased in the past decade. PICCs are central lines (CLs) commonly used for venous access. Midline catheters (MLs) can provide access when the need for a CL, such as vasopressors, is no longer present. MLs have a lower rate of BSI compared to PICCs and CLs, while providing dwell times comparable to PICCs. We established a project prioritizing ML use. Methods This is a quasi-experimental study in a 151-bed safety net community hospital. The pre-intervention period was January-December 2018 and post period was January 2019-December 2021. MLs were prioritized when new PICCs are requested without CL indications, such as total parenteral nutrition, hyperosmolar solutions and vasopressors. PICCs and CLs are transitioned to a ML once indications are no longer met and peripheral IVs are not feasible. Data on utilization and complications, such as deep venous thrombus (DVT) and BSIs, were reviewed and compared. Results A total of 63 peripherally inserted lines occurred prior to the intervention, of which 55 (87%) were PICC and 8 (13%) were ML (Figure 1). Post-intervention, 76 lines were placed the first year, of which 48 were ML (63%). This upward trend was sustained throughout the pandemic, with 116 lines in 2020 (80% ML) and 96 in 2021 (88% ML). No BSIs occurred during the pre-intervention and first post-intervention year. During the pandemic, 8 BSIs in MLs and 3 in PICCs occurred. The most common organism was Candida (Figure 2). The majority had COVID-19 (72%) and all (100%) BSIs were in the setting of shock. Case review demonstrated suspected secondary sources other than central venous catheters (CVCs). All BSIs with ML would have met NHSN criteria if CL present. No upper extremity DVTs were found. Conclusion A midline prioritization project was successfully implemented and sustained during the COVID-19 pandemic. The decline of PICC use from 87% to 12% suggests use for access without CL needs. High acuity during the pandemic led to BSIs that were likely secondary to shock and complications of COVID-19. All cases would have met NHSN criteria for CLABSI. The cost of a CLABSI is estimated at $48,108. Thus, this midline prioritization project may have led to CLABSI avoidance and an estimated cost savings of $384,864. Disclosures All Authors: No reported disclosures.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofac492.130
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
    detail.hit.zdb_id: 2757767-3
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  • 5
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    1108. Feasibility and Impact of a Monoclonal Antibody Infusion Program in Reaching Vulnerable Underserved Communities
    Oxford University Press (OUP) ; 2022
    In:  Open Forum Infectious Diseases Vol. 9, No. Supplement_2 ( 2022-12-15)
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)
    Abstract: Monoclonal antibodies (mAbs) against SARS-CoV-2 are potent therapeutics that prevent progression of disease in high-risk patients. Deploying mAb infusion programs and reaching communities in need remains challenging. We established a mAb infusion program centered in the emergency department (ED) fast-track. We seek to assess the feasibility and impact of our mAb infusion program in reaching vulnerable underserved communities. Methods The ED fast-track was repurposed for mAb infusions. Indications and protocols were created by the infectious disease (ID) physician and antimicrobial stewardship program (ASP). Test to treat was deployed in the ED and a referral program connected patients from telehealth and providers in the community to the infusion program (Figure 1). Data on mAb use from November 2020 to February 2022 was reviewed. To assess the reach of the program in vulnerable communities, the COVID-19 Community Vulnerability Index (CCVI) map by zip code was used. The CCVI identifies communities at risk by using variables such as sociodemographic variables, occupational factors, cumulative COVID-19 burden, vaccine uptake and other factors. Figure 1.Monoclonal antibody infusion test-to-treat and referral process in the ED fast track Results mAbs were successfully deployed and sustained throughout the pandemic, increasing its use in each COVID-19 surge by & gt;103% (Figure 2). A total of 267 patients were treated, with an average age of 52 years, of which 55% (147) were female. Ethnicity was 46% Hispanic and Race was 54% White, 28% Black, 1.4% Asian, 1.8% Multiracial and 14% Other. Zip codes by CCVI were 64% high, 18% medium, and 3% low CCVI index. 15% were outside of city limits without CCVI index (Figure 3). Figure 2.COVID-19 Community Vulnerability Index (CCVI) of patients who received monoclonal antibodies at our program Figure 3 Monoclonal antibody infusions by COVID-19 Community Vulnerability Index (CCVI) and Zip codes Conclusion A mAb infusion program with test to treat and referrals from the community was successfully deployed in an ED fast track. The ED space and staff can be leveraged for mAbs during surges amid clinic staffing challenges. The program adopted novel mAbs as new COVID-19 variants emerged. Uptake increased with each wave, likely reflecting awareness of mAbs and the infusion program by patients and providers in the community. The majority of patients served (82%) were of high and medium CCVI. Thus, this mAb infusion program led by ID and ASP successfully reached predominantly underserved vulnerable populations. Disclosures All Authors: No reported disclosures.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofac492.947
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 6
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    930. Weakening the waves: Impact of a syndrome-based antimicrobial stewardship intervention during COVID-19
    Oxford University Press (OUP) ; 2022
    In:  Open Forum Infectious Diseases Vol. 9, No. Supplement_2 ( 2022-12-15)
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)
    Abstract: Lower respiratory tract infections (LRTIs) from SARS-CoV-2 are difficult to distinguish from other viral or bacterial etiologies. This has led to increased antimicrobial use (AU) during the pandemic and concerns for concomitant rise in antimicrobial resistance (AMR). It is crucial for antimicrobial stewardship (ASP) to develop strategies to mitigate excess AU and curve AMR. We leveraged a syndrome-based ASP intervention targeting LRTIs and the use of anti-Pseudomonal beta lactams (APBL) during the COVID-19 pandemic. Methods We incorporated COVID-19 elements into a syndrome-based prospective audit and feedback (PAF) at an urban community hospital. Elements included EMR order sets (Figure 1) that discouraged routine AU for COVID-19 and PAF targeting LRTIs and COVID-19 therapies. Empiric selection discouraging APBL was incorporated during the first COVID-19 wave. Order sets and PAF were then modified to reflect novel COVID-19 therapeutics and AU was strongly discouraged in subsequent waves. Data on AU and AMR from 2018-2022 was reviewed. Figure 1.Electronic medical records COVID-19 antimicrobial order set Results Average quarterly AU increased during the first pandemic year by 8.7%, from 359.5 to 391 days of therapy per 1000 patient days (DOT/1000), with peaks 22.5% above the pre-pandemic average during COVID-19 surges. AU increased each COVID-19 surge, with smaller peaks each subsequent wave. DOT/1000 declined 29% from the first wave to the Omicron wave. AU decreased the second year to 318, an 18.6% decrease from the first pandemic year. Ceftriaxone use increased during surges, reflecting our LRTI guidelines (Figure 2). Peaks declined each subsequent wave, from a peak of 239 in the first wave to 75 during Omicron, a 68% decrease. The average monthly DOT/1000 for APBL decreased from 73.51 to 63.21 (Figure 3). Incidence rate of ESBL and CRE initially rose and then declined (Figure 4). Figure 2.Antimicrobial use (DOT/1000) before and during the COVID-19 pandemicFigure 4.Antipseudomonal beta lactam use before and during the COVID-19 pandemic Figure 5. Incidence of multidrug resistance organisms before and during the COVID-19 pandemic Conclusion ASP successfully incorporated COVID-19 elements and steered AU during the pandemic. Though total AU increased, APBL use declined and AU peaks decreased with each COVID-19 wave, reflecting adherence with ASP recommendations. AMR increased during the first year and subsequently declined. ASP can play a vital role guiding AU during respiratory pandemics. Disclosures All Authors: No reported disclosures.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofac492.775
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 7
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    929. A Nationwide Survey on the Role of Antimicrobial Stewardship Programs during the COVID-19 Pandemic: What is restricted and who decides?
    Oxford University Press (OUP) ; 2022
    In:  Open Forum Infectious Diseases Vol. 9, No. Supplement_2 ( 2022-12-15)
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)
    Abstract: During the COVID-19 pandemic, evolving literature and emerging therapies have led to significant controversies on what constitutes optimal therapy for hospitalized patients with COVID-19. In addition, multiple guidelines emerged exhibiting variable recommendations in key areas of therapeutic management. Thus, interpreting emerging data and deploying novel therapeutics during the pandemic has been challenging. Antimicrobial stewardship programs (ASP) have been proven to help promote evidence-based practices and are now common the United States (US). We seek to further understand the role of ASP during the COVID-19 pandemic. Methods A survey was developed and disseminated through Infectious Diseases Society of America (IDSA) IDea network, IDSA Antimicrobial Stewardship Centers for Excellence and the Society for Healthcare Epidemiology messaging boards. Data collected included city, hospital size, facility type, and existence of active ASP. COVID-19 therapeutic restrictions and type of provider who decides on treatment allocation was surveyed. Results A total of 92 surveys were completed, representing wide geographic reach within the United States (Figure 1). Hospital size by beds were 14% less than 200 (13), 18.5% 201-300 beds (17), 15.2% 301-400 beds (14), and 52.2% over 400 beds (48). Community hospitals accounted for 31.5% (29), county/public hospital 3.3% (3, 3.3%), University-affiliated Community-Based Teaching Hospitals 10.9% (10), University-based Teaching Hospital 45.7% (42), and 8.7% selected other. ASP were present in 97.2% of hospitals. COVID-19 therapeutic restrictions were common (Figure 2). Infectious diseases (ID) approval was required in 87.9% of facilities (Figure 3). Figure 1Geographic distribution of hospitals represented in the survey Figure 2. Restricted COVID-19 therapies by medication type (%) Figure 3 Specialties or providers that are able to order or approve restricted COVID-19 therapies (%) Conclusion COVID-19 therapeutics were commonly restricted during the COVID-19 pandemic. Approval by ID clinicians was required almost universally (87.9%). The role of other specialties was significantly lower, representing less than 45% of hospitals. ID clinicians have played a vital role in guiding therapy and supporting ASP during the COVID-19 pandemic. This survey highlights the value of ID clinicians to healthcare systems in allocating resources and promoting evidence-based practices through ASP. Disclosures All Authors: No reported disclosures.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofac492.774
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 8
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    1107. A Survey on Remdesivir Use and Antimicrobial Stewardship Restrictions Throughout the COVID-19 Pandemic
    Oxford University Press (OUP) ; 2022
    In:  Open Forum Infectious Diseases Vol. 9, No. Supplement_2 ( 2022-12-15)
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)
    Abstract: Remdesivir (RDV) was the first agent with proven clinical benefit against COVID-19, shortening the time to recovery in a randomized placebo-controlled trial (RCT). Based on this trial, the Food and Drug Administration approved RDV via emergency use authorization. Despite its wide use, RDV remains controversial. Early use of RDV in patients requiring low flow nasal canula has robust evidence. However, benefit in mechanical ventilation (MV), high-flow nasal canula (HFNC) and non-invasive positive pressure ventilation (NIPPV) is conflicting. Multiple studies, most notably the SOLIDARITY and DisCoVeRy trial, have conflicting results on who benefits from RDV. Deploying novel therapeutics in this changing landscape is challenging. We seek to understand RDV practices and the role of antimicrobial stewardship (ASP) in hospitals across the US. Methods A survey was developed and disseminated through Infectious Diseases Society of America (IDSA) IDea network, IDSA Antimicrobial Stewardship Centers for Excellence and the Society for Healthcare Epidemiology messaging boards. Data collected included city, presence of RDV therapeutic restrictions, and RDV use by degree of oxygen needs for each COVID-19 wave. Results A total of 78 responses were collected, representing wide geographic reach in the US (Figure 1). RDV was restricted in 53% of facilities. Hospitals without restrictions commonly used RDV for patients on MV, NIPPV and HFNC, with more use on HFNC than on NC during the first winter, Delta and Omicron waves (Figure 2). Use on MV declined with each surge. Hospitals with RDV restrictions had more use of RDV on NC than all other ordinal scales (Figure 3). Use in MV, NIPPV and HFNC compared to NC declined in the restricted group with each COVID-19 surge. Figure 1.Geographic distribution of hospitals represented in the survey Figure 2. Remdesivir use by oxygen requirements in hospitals without remdesivir therapeutic restrictions. Figure 3 Remdesivir use by oxygen requirements in hospitals without remdesivir therapeutic restrictions. Conclusion A wide gap between evidence-based guidelines and actual practice exists. This gap was wider in hospitals without COVID-19 therapeutic restrictions in place for RDV. In the unrestricted group, RDV was commonly used for MV, HFNC and NIPPV, where robust RCT evidence of benefit is lacking. Though this practice occurred in both groups, the restricted RDV group prioritized RDV use in NC and did so at higher percentages each subsequent COVID-19 surge. ASP restrictions can have an important role in guiding COVID-19 therapy. Disclosures All Authors: No reported disclosures.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofac492.946
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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