Subject Area Data Element Examples Earliest Date Patient Demographics Race, primary language, mortality 2000 Encounters
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1 User Guide DataDirect is a self-service tool enabling access to robust, up-to-date data on more than 3 million unique patients from across the UMHS enterprise. This data informs study design and guides the determination of feasibility of eligible patients for recruitment. DataDirect Prerequisites: Your Level 2 password Completion of any PEERRS module Data Available for COHORT FEASIBILITY (as of October 2016) Cohort mode produces aggregate counts for a given set of criteria. Subject Area Data Element Examples Earliest Date Patient Demographics Race, primary language, mortality 2000 Encounters Dates (admission, discharge, clinic visit), primary 2000 provider, location Diagnoses Dx name, fee code, POA flag 2000 Procedures Procedure name, fee code 2000 Medications Ordered Name, dose, frequency 2004 Medications Administered Name, dose, frequency, route 2004 Labs Test name, result range 2004 Waveform Location, type of waveform (EKG, pulmonary artery 2012 Pressure), duration Central Biorepository Study name, tissue type 2014 Data Available for DOWNLOAD, with appropriate IRB (as of October 2016) Data available through DataDirect reflect your current IRB-approved, active data elements as granted by the Data Office. Subject Area Patient Demographics Direct Patient Identifiers Encounters Diagnoses Procedures Medications Ordered Medications Administered Labs Nursing Flowsheets Sensitive Data Element Examples Race, primary language, mortality Name, address, MRN Dates (admission, discharge, clinic visit), primary provider Dx name, fee code, POA flag Procedure name, fee code Name, dose, frequency Name, dose, frequency, route Test name, result value, units, high/low flag Vitals by hour, daily min/max, Fluid In/Outs HIV testing, HLA typing Updated
2 Table of Contents ACCESSING DATA DIRECT... 3 CREATING A NEW QUERY... 4 COHORT RESULTS MODIFYING A FILTER.. 8 EXCLUSIONS...12 OR LOGIC AND LOGIC SUMMARY STATISTICS REQUESTING ACCESS TO DATA WITH IDENTIFIERS FOR DOWNLOAD TOGGLING BETWEEN QUERY MODES 22 CREATING OUTPUT VIEWS DATA INLCUDED IN EACH VIEW. 24 ATTESTATION STATEMENTS AT TIME OF DOWNLOAD.. 25 BUILDING DATASETS FOR DOWNLOAD. 26 RUNNING THE QUERY UPLOAD PATIENT LIST
3 Accessing DataDirect As DataDirect evolves, concepts presented in this User Guide will remain accurate, but the screenshots may vary slightly within the DataDirect tool. Access DataDirect at: Login with your User ID (UM uniqname) and Level 2 password. Click the Submit button. 3
4 Creating a New Query (Cohort Mode) Upon logging in, select Create a new blank query to proceed (or Select an existing query to use a previously created query). Enter a name and description for your query, then click Create New Query. Cohort Mode does NOT require HUM Number. 4
5 From the filters listed in the left panel, select a filter, for example, Demographics, to begin defining criteria for your query. Cohort Query Mode Demographics are patient-level characteristics available from the administrative registration systems (not encounter-level data, in other words, they do not change from one encounter to another). Select the checkboxes beside the characteristics to include in your query. De-select items you do not wish to include. For example, to find only Female patients, de-select Male and Unknown under Gender. Click Add to add these criteria to your query. Click Add EACH time you add criteria to save your query. 5
6 Cohort Results As DataDirect retrieves data to match the selected criteria, the right panel of the screen displays aggregate counts. Your query is also saved to your individual profile in DataDirect. Results include 1) initial patient and encounter counts, 2) saved criteria, and 3) final aggregate count of patient data matching your query. As you build your query, check the right panel to verify that your criteria have been added. Initial patient and encounter counts Saved criteria Final aggregate count 6
7 Modifying a Filter (Enable/Disable, Edit and Remove) At any time, you may enable/disable, edit or remove an individual filter from your query. Enable/disable, Edit & Remove icons To continue to build your query, select an additional filter category, for example, Encounters. 7
8 Tip: Begin typing to filter the selection criteria. For example, in the Inpatient Service Location field, type 5D to narrow your search. DataDirect includes aliases for locations, e.g., 8D5 or SICU. Click or highlight the item to select it for a field. 8
9 Review the updated result panel on the right side of the screen each time you click Add to note the additional criteria have been saved to your query. In this example, both Demographics and Encounter criteria have been added to the query, and an aggregate count has been generated: 9
10 Select Diagnosis, and begin typing the desired diagnosis name (or associated ICD-9 code) into the Diagnosis Code field. Highlight the code you desire, then click Add Selected. Top Results most frequent Alphabetic listing As you select a diagnosis code, the parent ICD-9 code and its associated child ICD-9 codes will be displayed and automatically included. De-select (click the red X) any individual code you wish to remove from the suggested list. Inclusion is the default selection. Tip: *Remember, click Add with each criteria addition or modification to save it to your query. 10
11 Exclusions To exclude a characteristic in your query (e.g., run a query to retrieve patients who do NOT have Lupus), you must UNCHECK the Inclusion / Exclusion checkbox. When the box is unchecked, the indicator Exclusion appears in bold print. Or Logic You may be interested in patients who have either one condition or a second condition. For example, if you were interested in Patients with Lupus OR Patients with Diabetes, use OR logic. Lupus Diabetes The TWO groups Patients Patients will be retrieved with OR logic To achieve this, include the Diabetes criteria in the same criteria box as the Lupus diagnoses. Open the existing Diagnoses query for Lupus. Click the Edit icon to edit the Diagnoses filter. 11
12 Enter the second criteria, e.g., Diabetes. Select the desired code(s) by clicking Add Selected. Remove any child ICD9 codes that you do not wish to keep (by clicking the red X for each). Click Update (both conditions will be listed, as below). 12
13 DataDirect will display the codes within the same criteria box on the right side of the screen, indicating that the retrieved results include patients with code (Lupus) OR patients with code (Diabetes). Includes diagnoses codes: 710 (Lupus) OR 250 (Diabetes) 13
14 And Logic In contrast, if you are interested in patients who have BOTH Lupus AND Diabetes diagnoses, use AND logic. Patients with Lupus Patients with Lupus AND Diabetes Patients with diabetes Only patients having BOTH Lupus and Diabetes Diagnoses To find these patients, build two separate filters (one for Lupus, and a separate one for Diabetes). Start with an initial Diagnosis filter including Lupus. Initial Diagnoses filter for Lupus (code 710) 14
15 Build an additional Data Source (Diagnosis) by returning to the main filter list. Click Diagnoses, enter Diabetes into the Diagnosis code field, and click Add Selected to create new, separate criteria. After specifying the details (refining your ICD9 codes if desired), click Add. 15
16 The additional required criteria appear as a separate criteria box in the right hand panel, and the narrowed query results show a far more limited population of patients only those patients who possess BOTH of the listed diagnosis codes (710 and 250). Separate Diagnoses Criteria filters represent AND logic patients who have Lupus AND Diabetes 16
17 Each of the displayed criteria boxes in the right-hand panel represents an AND statement in other words, all retrieved patients must possess ALL of these criteria: Retrieve patients who are Female with these races and Alive/Unknown AND have Encounters with dates of service between 1/1/13 1/1/15 AND have Lupus AND have Diabetes Tip: Each time that you click Add, you are adding a new criteria panel (an AND statement to the query). 17
18 Continue to build and refine your query using Data Sources on the left-hand panel. Refer to the instructions inside each filter panel to determine the source and details for the information available. If you wish to retrieve data related to Laboratory collections, you may select details for Ordered and well as Resulted Laboratory tests. When you select Laboratory Results data, you may include or exclude results within specific value ranges. Note, specifying a value range only works for lab values that are numeric (as opposed to pos, neg ) For each filter you wish to add, click Add to save it to your query. 18
19 In addition to the Procedures, Outpatient Medications, Medication Administration (the MAR), and Laboratory filters, you may select Waveform data for specific dates, from specific UMHS units, including duration details. Central Biorepository sample data is also available to be added as criteria to your query including Age at Date of Collection, Study, Sample Type, Clinical Diagnosis, and Tissue Type. Again, be sure to click Add for any criteria details you would like to include in your query. 19
20 Summary Statistics ( At-a-Glance ) After completing a cohort feasibility query, click Run At-a-Glance to access summary statistics about the cohort population. To download this summary table, click Generate File button for a CSV file. 20
21 Requesting Access to Data with Identifiers for Download ( Get Your Data ) The first time you wish to access data for a given study, a formal request to the Data Office is required. Upon completing your cohort feasibility query, click on Get Your Data. Click on the hyperlink to access the Data Office request form. 21
22 Toggling Between Query Modes To switch from Cohort Mode to PHI Download Mode (or vice versa), select the Edit icon section entitled Currently Selected Query. under the Select the desired mode for your query, then click Change Query Mode. 22
23 Creating Output Views Selecting from among enabled/allowable data domains. The Data Office will review your IRB application, and add you to only the data domains for which you have approval. Grayed-out Output Views are those to which you do not currently have access. 23
24 Data Included in Each View Within a data domain (like Diagnoses), select the granularity of data to best answer your research question. For example, select the Diagnosis Output View. To select more granular detail, click the checkbox beside the item, and then click each desired item to change the symbol to a green plus sign (indicating that you wish to include it). The red X items display in strike-through to indicate they will not be included. 24
25 Attestation Statements at Time of Download Read and attest to each statement as a requirement for each file download. Use the link within if you have forgotten the password you set for the download file. 25
26 Building Datasets for Download PHI Mode After logging in, select Create a new blank query to proceed (or Select an existing query to use a previously created query). Enter a name and description for your query, provide your HUM number (for your approved, active study) select the Query Mode (PHI), then click Create New Query. PHI Mode requires a HUM Number. You may also select an existing query and create a download for it, by editing the cohort query and toggling the Query Mode to PHI. Provide your HUM number when prompted. 26
27 Select the Output View Selection filter (data domain) for which you have been granted access. For this example, we will select Demographic. Check the box beside the desired output to expand the selections. Click each item to change the symbol to a green plus sign beside the column descriptions to add to the view. Items remaining with a red x and strike-through will not be included. 27
28 By selecting these data items, you will save the output into your Output Views (lower right hand corner of the screen). No additional Save button is required. Only if you require them, select Direct Patient Identifiers from the Output View Filter (if approved), and check the box to select PatientInfo. 28
29 As you click the data item, a green plus sign appears indicating that you will include these specific identifiers. DataDirect will require you to confirm that you need to view this sensitive data. Click Yes to proceed. Acknowledge this for each data point you require. Continue to select Output View filters and criteria as needed. Preview of the type of data selected. Each variable has a column (fictitious). 29
30 Scrolling down in the Diagnosis window, you can access and select Charlson Elixhauser Scores (depending on your approval). Continue to build the Output View (Procedure, Medication, Laboratory, Nursing Flowsheet) per your approval and your needs. 30
31 Running the Query PHI Mode When ready to build your Query, click the Run Query button. You will be required to provide a strong password (to encrypt the file you are about to download), confirm that password, and you have the option to receive an when the Excel file is ready for download. Click Run Query when you have completed the required fields. Note: This is NOT your DataDirect password; it is the password for the Excel file, to encrypt it. It will be required to be entered when you attempt to open the file. 31
32 The Progress bar at the top of the screen will indicate DataDirect s status in building your download. Provided that you checked the box in the earlier step prior to Running the Query (which is the default setting), you will receive an from DataDirect notifying you when your Download is available. You can start a new query or move on while the system builds your file. Please keep in mind compliant practices when handling and storing your data. Please check back for updates. The DataDirect Team will make enhancements to the tool. For assistance and questions, please use the Support link within DataDirect. 32
33 Upload Patient List To upload a list of MRN s, select Upload List Under Cohort Discovery Tool. Once selected you will be presented with a list of 4 steps. Step 1 includes preparing your data file. 33
34 Upload Patient List - Step 1 (Preparing your data file) Please note, there are 3 options for preparing your data in excel: Option 1: If uploading MRN s only, create a table with 1 column (A). Label column A MRN A MRN Option 2: If uploading MRNs, CSNs and Admit Dates, create a table with 3 columns (A, B, C). Label column A MRN Label column B CSN Label column C Admit Date, format dates as YYYY/MM/DD A B C MRN CSN Admit Date /10/ /01/ Option 3: If uploading MRNs and Admit Dates only, create a table with 3 columns (A, B, C). Label column A MRN Include column B but leave entire column blank, Admit Dates should not be added to column B Label column C Admit Date, format dates as YYYY/MM/DD A B C MRN Admit Date /10/ /01/
35 After preparing your excel file, continue with Steps 2-4. Once your excel file is successfully uploaded, see page 23 (Creating Output Views) for how to create output data about these patients. 35
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