Study protocol for COvid-19 Vascular sERvice (COVER) study: The impact of the COVID-19 pandemic on the provision, practice and outcomes of vascular surgery
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Abstract
The novel Coronavirus Disease 2019 (COVID-19) pandemic is having a profound impact on global healthcare. Shortages in staff, operating theatre space and intensive care beds has led to a significant reduction in the provision of surgical care. Even vascular surgery, often insulated from resource scarcity due to its status as an urgent specialty, has limited capacity due to the pandemic. Furthermore, many vascular surgical patients are elderly with multiple comorbidities putting them at increased risk of COVID-19 and its complications. There is an urgent need to investigate the impact on patients presenting to vascular surgeons during the COVID-19 pandemic.
Methods and analysis
The COvid-19 Vascular sERvice (COVER) study has been designed to investigate the worldwide impact of the COVID-19 pandemic on vascular surgery, at both service provision and individual patient level. COVER is running as a collaborative study through the Vascular and Endovascular Research Network (VERN), an independent, international vascular research collaborative with the support of numerous national and international organisations). The study has 3 ‘Tiers’: Tier 1 is a survey of vascular surgeons to capture longitudinal changes to the provision of vascular services within their hospital; Tier 2 captures data on vascular and endovascular procedures performed during the pandemic; and Tier 3 will capture any deviations to patient management strategies from pre-pandemic best practice. Data submission and collection will be electronic using online survey tools (Tier 1: SurveyMonkey® for service provision data) and encrypted data capture forms (Tiers 2 and 3: REDCap® for patient level data). Tier 1 data will undergo real-time serial analysis to determine longitudinal changes in practice, with country-specific analyses also performed. The analysis of Tier 2 and Tier 3 data will occur on completion of the study as per the pre-specified statistical analysis plan.
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SciScore for 10.1101/2020.05.27.20114322: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Overview of COVER: COVER will be run as a worldwide collaborative research project. COVERsuggested: (Cover Pages, RRID:SCR_004955)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Study limitations: COVER is a pragmatic real-world study. The nature of the current …
SciScore for 10.1101/2020.05.27.20114322: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Overview of COVER: COVER will be run as a worldwide collaborative research project. COVERsuggested: (Cover Pages, RRID:SCR_004955)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Study limitations: COVER is a pragmatic real-world study. The nature of the current pandemic has meant that an appropriate sample size is difficult to calculate. Additionally, the dynamic nature of the COVID-19 pandemic means that numbers of cases, including those testing positive for or suspected to have infection with the SARS-CoV2 virus - hence a denominator for some calculations - are unknown. This insurmountable problem is not limited to this study and is currently frustrating efforts to determine appropriate strategies for lifting the lockdown in countries where the peak of the pandemic appears to have passed. Many countries have scaled back elective practice and changed thresholds for operating on carotid stenosis and aortic aneurysms to varying degrees and along different timelines due to resource scarcities. This will have an impact on the volume of cases uploaded into Tier 2 and Tier 3 of the study, but the concurrent completion of Tier 1 should reflect this and has already provided live data from over 150 institutions in 45 countries across the globe. In the first instance, country-specific experiences have been shared to highlight practice changes around the globe with vascular colleagues. This information will also be used when analysing country-specific trends for surgery and referrals. This will allow inclusion of important variables such as type of hospital (private or government-run), loss of specialty firms with the redeployment of staff to support other spe...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title ISRCTN80453162 NA NA Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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