(New) Research Minor Data Requests

• The listed principal investigator (PI) must be an active participant surgeon or surgeon representative in the STS National Database.
  • The Database ID provided must correspond to the specialty registry that will be used in the research proposed by the investigative team, e.g., General Thoracic proposals should provide a participant ID corresponding to the GTSD.
• STS will consider and approve a maximum of two Research MDRs per PI in a given calendar year. 

• Preliminary data generated from a Research MDR may be used as background information for a subsequent STS research program proposal or grant application, with STS Research and Analytic Center (STS RAC) approval.
• Research MDR results will not include multivariable modeling or complex statistical analysis.
• Research MDRs cannot be combined with or compared to externally sourced data.
• Research MDRs should be designed to not exceed four hours of STS Data Analytic Center time.
• Shell tables clearly describing the expected results format must be included in the Research MDR application (see ‘Required Application Materials’ example below). 

Please gather the following required items before starting your Research MDR application, which must be completed in one session:

1. STS National Database Participant ID corresponding to the investigator's participant institution and research MDR focus; specifically the 5-digit ID for the Adult Cardiac Surgery Database (ACSD), General Thoracic Surgery Database (GTSD), Congenital Heart Surgery Database (CHSD), or the 4-letter code in case of Intermacs/Pedimacs participants.  
2. A brief description of the potential research plan which should include the following sections:

Research MDR Research Plan

1. Research Question, Aims, & Hypotheses
   1. How will this data be used (i.e., for what purpose) and what research program you are interested in submitting a full proposal to (e.g., to STS Funded or Institutionally Funded)?
   2. What is your research question?
   3. A brief background or rationale for the research question.
   4. Study Time Frame: start date and end date for the data to be analyzed
2. Study Plan and Inclusion/Exclusion Criteria
   1. Study Patients
      1. Include study years and corresponding database versions.
      2. Provide a clear logic for patient inclusion and exclusion criteria.
      3. Specific database fields/variables (including sequence number and variable short names) and corresponding inclusion or exclusion “value” should be clearly indicated.  
      4. Consult with your team and use “AND” and “OR” statements to construct your logic.
   2. Study Inclusion Criteria
   3. Study Exclusion Criteria  
   4. Endpoints and Outcomes
3. Shell Table
   1. Shell tables clearly describing the expected results format must be included in the Research MDR application (maximum 20 cells; see example below) 

   2. Characteristics	Number of Patients (n)	Number of Operations (n)
      Age
      18 – 40 years
      41 – 80 years
      Incision Type
      Sternotomy (all)
      Thoracotomy (all)
      Diagnosis
      Conduit Failure
      Pulmonary Artery Stenosis
      Pre-Op Risk Factors
      Renal Failure
      Sepsis

4. Variable List
   1. Please provide a specific list of all relevant Database variables needed to fulfill this Research MDR. Further information on variables in each registry can be found below:
      1. ACSD: Adult Cardiac Surgery Database Data Collection
      2. GTSD: STS General Thoracic Surgery Database
      3. CHSD: STS Congenital Heart Surgery Database
      4. Intermacs: De-identified Intermacs Data Set; Intermacs Users Guide
      5. Pedimacs: De-identified Pedimacs Data Set; Pedimacs Users Guide

NOTE: Research MDRs that do not provide detailed inclusion/exclusion criteria, list of relevant variables, and a shell table will not be considered. 

• The STS RAC confirm receipt of the Research MDR via email to the PI (and contact person, if applicable).
• The Research MDR is reviewed by the STS RAC and appropriate Research Task Force Chair(s) for eligibility and completeness; STS RAC requests feedback from the investigator as needed.
• If the Research MDR is not approved, the STS RAC notifies the PI accordingly. If approved, the PI is informed and the MDR is moved to analysis.
• Once complete, the STS RAC will provide Research MDR results to the PI via email in a Word document report format.