TEMPLATE PROTOCOL



PROTOCOL TITLE:Transesophageal echocardiography (TEE) with and without GI workup—a retrospective chart review. PRINCIPAL INVESTIGATOR:Joe Jones, M.D.USF Morsani College of MedicineDepartment of Internal Medicine813-974-5555jjones@health.usf.eduVERSION NUMBER/DATE:V1, September 5, 2019.REVISION HISTORYRevision #Version DateSummary of ChangesConsent Change?Table of Contents TOC \o "1-3" \h \z \u 1.0Study Summary PAGEREF _Toc18562912 \h 32.0Objectives PAGEREF _Toc18562913 \h 43.0Background PAGEREF _Toc18562914 \h 44.0Procedures Involved PAGEREF _Toc18562915 \h 45.0Data and Specimen Storage for Future Research PAGEREF _Toc18562916 \h 56.0Inclusion and Exclusion Criteria PAGEREF _Toc18562917 \h 57.0Vulnerable Populations PAGEREF _Toc18562918 \h 58.0Data Sources PAGEREF _Toc18562919 \h 59.0Risks to Subjects PAGEREF _Toc18562920 \h 510.0Potential Benefits PAGEREF _Toc18562921 \h 511.0Data Management and Confidentiality PAGEREF _Toc18562922 \h 512.0Provisions to Protect the Privacy Interests of Subjects PAGEREF _Toc18562923 \h 613.0Consent Process PAGEREF _Toc18562924 \h 614.0Setting PAGEREF _Toc18562925 \h 7Study Summary Study TitleGI consultation prior to TEEStudy DesignRetrospective chart reviewPrimary ObjectiveAssess outcomes after TEE in patients grouped by GI intervention or no GI interventionSecondary Objective(s)N/AStudy PopulationAll patients 18 and older admitted to TGH between 7.1.2008 and 7.1.2018 for whom a TEE was ordered during the inpatient stay. Sample Size10,000 recordsStudy Specific Abbreviations/ Definitions Esophagogastroduodenoscopy (EGD)Transesophageal echocardiography (TEE)Objectives 2.1 Assess outcomes after TEE in patients grouped by GI intervention or no GI intervention.2.2 In patients with similar GI history and symptoms, those who undergo TEE without GI workup will have a similar outcome to those who undergo TEE with preceding GI workup. Background3.1 Zuchelli et al. evaluated EGD prior to TEE in patients with a history significant for GI symptoms and/or diseases. Zuchelli, T, et al. “Does an Upper Endoscopy before Transesophageal Echocardiography Change Patient Management.” J Clin Gastroenterol. 2015 Nov; 49(10): 848-52. The population was 134 adult patients at a tertiary care center who underwent EGD for clearance prior to TEE. Twenty patients (15%) were not cleared for TEE due to findings of the EGD. Two patients who underwent EGD and five who underwent TEE had unspecified cardiopulmonary complications. The researchers concluded that EGD prior to TEE was useful for providing clearance due to endoscopic findings. Procedures Involved4.1 This is a retrospective chart review of patients admitted to TGH who underwent a TEE during their inpatient stay.4.2 Please select the records that will be reviewed in this study (select all that apply): ? Record Review - Educational? Record Review - Employee? Record Review - Medical? Record Review - Publicly Available Dataset? Record Review - Prisoner? Record Review - Other ? Existing Specimen Analysis4.3 Data abstracted from Epic will include the variables listed on the data collection sheet uploaded into BullsIRB. MRNs and dates will be the only identifiers collected. A separate master data collection sheet will be maintained by the PI; once all data is collected, the data set will be de-identified and subjects will be assigned an ID. The master list will be stored separately as described below. PI has clinical and research privileges at TGH and thus has access to Epic. A request for the approved data set will be submitted to TGH IT and the data will be abstracted from Epic by TGH IT as per their standard process. 4.4 N/AData and Specimen Storage for Future ResearchN/AInclusion and Exclusion Criteria6.1 All patients 18 and older admitted to TGH between July 1, 2008 and July 1, 2018 who underwent a TEE during their inpatient admission will be included in the analysis. There are no exclusion criteria. Vulnerable PopulationsN/AData Sources8.1 All records will be abstracted from the TGH instance of Epic. Risks to Subjects9.1 The only risk to subjects is a risk of breach of confidentiality. Potential Benefits 10.1 If EGD is demonstrated to be unnecessary in mitigating the risks associated with a TEE, the potential benefits to future patients include decrease in costs associated with a TEE, decrease in time spent under anesthesia and shorter lengths of stay. Data Management and Confidentiality11.1 Once provided by TGH IT, the identified data set will be stored on the PI’s password-protected desktop computer, located in a locked office at TGH. The de-identified data set will be uploaded into a shared folder on the TGH network, to which all approved study team members have access. 11.2 Data provided by TGH IT will contain MRNs and dates. At the earliest opportunity, the data set will be de-identified and subjects will be assigned a subject ID. The PI will maintain the link; the de-identified data set will be shared with study team members via a shared folder on the TGH network, which is behind a HIPAA firewall. The data will be kept for 5 years after the final report is submitted to the IRB. After submission of the final report, it will be destroyed by permanently deleting it from the PI’s desktop computer.11.3 ? Obtaining Online or Verbal Authorization (Alteration of HIPAA Authorization)? Obtaining Signed Authorization? Waiver of HIPAA Authorization for Entire Study? Data Use Agreement? Business Associate AgreementA waiver of authorization is requested as it is not practicable to obtain authorization from all subjects who will be included in the cohort. Many of these subjects were admitted to TGH many years ago and will be lost to follow-up. The study cannot be conducted without access to and use of subjects’ PHI; dates will be used to calculate time between procedures and length of stay. We will not disclose subjects’ PHI to anyone outside the study team. A master data collection sheet will be maintained until data analysis is completed; at that time, the master data collection sheet will be destroyed. Provisions to Protect the Privacy Interests of SubjectsNAConsent ProcessN/ASetting14.1 The research will be conducted in the GI Department at TGH. ................
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