REDCap Best Prac/ces. ITHS Biomedical Informa2cs Core Bas de Veer MS Research Consultant

Transcription

1 REDCap Best Prac/ces ITHS Biomedical Informa2cs Core Bas de Veer MS Research Consultant REDCap version: Last updated February 10,

2 Goals & Agenda Goals Understanding Advanced Features Best Prac2ces Agenda Randomiza2on REDCap- Amalga Bridge Dynamic SQL links User Right Management Study Design Surveys Data Quality 2

3 Randomiza2on 3

4 Randomiza/on What s randomiza2on? Divide your study par2cipants in 2 or more groups without bias. REDCap offers: Stra2fied Randomiza2on Randomiza2on by Group/Site Granular User Rights 4

5 Randomiza/on How does it work? Ac2vate the Randomiza2on feature Select your op2ons & Randomiza2on Field Create the Randomiza2on field on the first form Set up Alloca2on Tables Contact a Bio- sta2s2cian Development VS Produc2on Define User Rights Start Data Collec2on & Randomize Monitor the Randomiza2on Process 5

6 REDCap Amalga Bridge 6

7 REDCap- Amalga Bridge What s Amalga? Clinical Data Warehouse for UW Medicine Outpa2ent (EPIC) Inpa2ent (ORCA) Labs ADT Many other clinical systems NOT Instantaneous Reports Require AMC Account Strict Direct Access Policies DCDR (De- iden2fied Clinical Data Repository) 7

8 REDCap- Amalga Bridge Import Clinical Data directly into a REDCap project One- 2me Update on a Regular Basis Based on your Iden2fiers Import REDCap data into Amalga As Source Data for your Amalga Query To Generate a Custom Report Do Advanced Calcula2ons/Manipula2ons Notes: Have an IRB in place Requires Development Time from the BMI Consult Team 8

9 REDCap- Amalga Bridge Repor2ng Example REDCap- Amalga Bridge Example REDCap Secure Hospital Compu/ng Environment Study Database Study Data Custom C# Library Secure Report 9

10 REDCap- Amalga Bridge REDCap- Amalga Bridge Example REDCap Secure Hospital Compu/ng Environment Iden/fier Database Pa/ent Name, MRN Query Study Database Study Data Custom C# Library Query Results UW* Clinical Data Repository * University of Washington 10

11 Dynamic SQL Link 11

12 Dynamic SQL Link Rela2onal Database Mul2ple tables Cross links (Primary keys) Example: Access Database En2ty- Aaribute- Value Database 1 Big Flat File 1 Record per Row Example: Single Excel Spreadsheet Example: A REDCap Project 12

13 Dynamic SQL Link Special Dropdown Field Populate by a Custom Code (SQL) Other REDCap projects Special Tables Consists of: Raw Value Label Single Value Combined Values Only available to a REDCap Administrator Filters Can be Applied 13

14 Dynamic SQL Link Limita2ons Only Editable by a REDCap Administrator Data Dic2onary will NOT upload when you: Change the Posi2on of the Field Edit the Label Edit the Variable Name Edit the SQL Code Cost 200 Dollars per Link Only to Projects You have Access to 14

15 Dynamic SQL Link Adverse Events Example: Longitudinal Studies Unknown Number of Adverse Events Example Solu2on: 2 Projects (Main Database & Adverse Events) 1 Record per Adverse Event D- SQL used to link to Main Database Raw Value: Main Database Study ID Label: MRN, Last Name, Date of Birth 15

16 Dynamic SQL Link Iden2fica2on Database Example: Need for a Separa2on of PHI from Study Data Don t Want to Go the Excel Route Example Solu2on: 2 Projects (Main Database & Iden2fier Database) 1 to 1 Record Matching D- SQL used to link to Iden2fier Database Raw Value: Iden2fier Database Study ID Label: Iden2fier Database Study ID 16

17 Dynamic SQL Link Applica2on VS Reviewer Example Applica2on Survey & a Reviewer Survey Prevent Transcrip2on Errors Mul2ple Reviewers for Each Applica2on Solu2on: 2 Projects (Applica2on Project & Reviewer Project) Mul2ple Review Surveys per Applica2on D- SQL used to link to Applica2on Project Raw Value: Record ID Applica2on Project Label: Last Name, Applica2on Title (limit to 1 st 35 Characters) 17

18 User Rights 18

19 User Rights Roles Can Be Created by Users With User Rights Rights Quickly Assign Pre- Defined User Rights One Time Setup Per Role Roles Are Editable Removing a User From a Role Copies the Role s Sejngs to the User Un2l: A Manual Edit The User Is Assigned to a Different Role Expira2on dates s2ll need to be setup per user 19

20 User Rights Best Prac2ces For User Roles: User Control Design Control Data Entry Reviewer Research Coordinator Project Manager/PI Sta2s2cian 20

21 User Rights Basic Applica2on Access Limit to Only Necessary Applica2ons Rights Keep the User s Role in Mind Op2ons Depend on Ac2ve Features Take Special Care with: Project Design User Rights Data Export Tool Data Import Tool 21

22 User Rights Form Restric2ons Limit Form Access to Specific Users or Roles View & Edit Read Only No Access Edit Survey Responses (Semi- Independent) Useful for Complex Studies 22

23 User Rights Data Access Groups (DAGs) Users in a DAG Can Only See Records Created by Members of that Same DAG Excep2on: Users Without a DAG Useful for: Double Data Entry Separa2ng Different Sites Records Without a DAG Assigned: Done by User Without a DAG Top Right Corner of Any Form of a Record Users Can Only Export Records in Their DAG 23

24 User Rights Locking Useful for Bigger Projects Safe- Guard Data Integrity Mul2ple Data Entry Users Use in Combina2on with the Unverified Tag E- Signature Does NOT Work Lock Records By Form En2re Record 24

25 Study Design 25

26 Study Design Consider Splijng Up Forms in These Situa2ons: In Development Mode Longitudinal Studies Scoring Tools (FACT- L, Glascow, etc) Notes: Overview Contained Modules More Frequent Saves Flexibility in Workflow Design Easily Undone Via Data Dic2onary 26

27 Study Design Variable Names: Short & Consistent Lower Case Decipherable Codes For Repea2ng Variables (Shorthand) Sequen2al Context Based Consult Your Sta2s2cian Examples: Medica2on Number 1 In a Follow Up Eligibility Ques2on Number 4 è rxfu1 è eligq4 27

28 Study Design Record ID s in REDCap: Always The 1 st Variable In The 1 st Form Used By REDCap to Link Variables to a Record Turn on Auto- Numbering Create a Second Unique Variable For Your Study ID Duplicate Record ID s cause: Analysis Errors Export Errors Back- Up Errors Screw- up Advanced Features 28

29 Form Design 29

30 Form Design Try to Design Your Variables as Granular As Possible: Easy to Go Less Granular Harder to Go More Granular Consider The Smallest Measurement Unit Makes Unexpected Analysis Paths Easier Examples: Age (Category vs Years vs Months vs Days) BMI (Split it out in Height and Weight) Blood Pressure ( Normal vs Diastolic/Systolic) 30

31 Form Design Raw Value Choice Coding (For Mul2ple Choice Fields) Try To Use A Numeric Value Easier To Analyze Shorter Logic/Calcula2ons Less Change Of Typo s Reserve Room For Addi2onal Choices When Using a Non- Numeric Value Try To: Keep It Short Avoid Comma s Do NOT Include HTML Tags Use It For Piping Of Non- Numeric Values 31

32 Form Design Calcula2ons: Shorter Is Beaer PEMDAS is Your Friend Match Up Those Parentheses. For Advanced Func2ons è FAQ Calcula2ons Can Only Produce Numbers or NaN Calcula2ons DO Run Automa2cally (since 6.4.0) Calcula2ons Can Produce An Outcome Without All The Variables Filled Out (When Using Logic) Use Excel For Quick Troubleshoo2ng 32

33 Form Design Cascading Calcula2ons Is Allowed, But Not Advised Can Be Hard To Troubleshoot No Limit On Length Of A Calcula2on Example: [calc1] è [var1] + [var2] [calc2] è [calc1] + [var3] [calc3] è if([calc2]<[var4],[var3],[var5]) 33

34 Form Design - Branching Logic Branching Logic Keep It Short Put Parentheses Around Everything Limited Java Func2ons Allowed è FAQ Make Use of Nested IF Statements Try to Keep Your Logic Local Be Aware of Radio Buaons VS Checkboxes [var1] = 1 [var1(1)] = 1 Diagram Your Logic Cascade Your Logic When Possible 34

35 Form Design - Branching Logic Logic Diagram Example: True IF([var] = 1 False [var2] = 1 [var5(2)] = 1 OR OR [var3] = 1 AND [var4] =0 [var5(3)] = 1 AND [var6] = 0 35

36 Form Design - Branching Logic Actually Syntax: If([var1]=1,(([var2]=1) OR ([var3]=1 AND [var4]=0)),(([var5(2)=1) OR ([var5(3)]=1 AND [var6]=0))) Split Out: If([var1]=1, ) ( ([var2]=1) ), OR ([var3]=1 AND [var4]=0) ( ([var5(2)=1) ) OR ([var5(3)]=1 AND [var6]=0) 36

37 Form Design - Branching Logic Variable is Empty Trick Useful for: Cascading Logic Delaying a Field Un2l Everything Is Filled Out Syntax: [var1] <> Notes: Double Quotes Do Work, but might mess up Excel Use Two Single Quotes Without a Space In Between 37

38 Form Design - Branching Logic Cascading Logic Medica2on List Example List of 6 Medica2ons (rx1, rx2, rx3, rx4, rx5, rx6) Branching Logic Example: rx2 è [rx1] <> rx3 è [rx2] <> rx4 è [rx3] <> rx5 è [rx4] <> rx6 è [rx5] <> 38

39 Form Design - Branching Logic Cross Event Branching Logic Depended On: If A Form Is Repeated If Your Study Is Longitudinal If Your Target Variable Is In Another Form Notes Event Name Is Located In Define My Events Try To Use It For All Your Logic In A Longitudinal Study Syntax Example: [event1][var1]=1 39

40 Form Design - Branching Logic Hiding Fields Instead Of Dele2ng Or Edi2ng Fields Best Prac2ce No Data Loss Easier/Quicker To Create A New Variable Create An Impossible Scenario That Is Never True Old Choices Are Kept (In Case Of A Mul2ple Choice Edit) Syntax Example: [record_id]=

41 Form Design - Piping Variables Display Entered Variables Field Labels Survey Invita2ons Survey Thank- You Message Piping Syntax Original Variable Name first_name [first_name] Example First Name Value = John Syntax in Thank- You Message = Thanks, [first_name]! Becomes = Thanks, John! 41

42 Surveys 42

43 Surveys Four Main Ways of Distribu2ng Surveys: Public Links Personalized Invita2ons Automated Invita2ons Survey Queue s Bonus: Fill Out a Survey as a User 43

44 Surveys Managed Through the Manage Survey Par2cipant Link Public Links Ideal For Recruitment Ini2ally Anonymous Can Be Filled Out Mul2ple Times Auto- generated by REDCap (Short Link, QR codes Available) Only Available For the First Survey of Each Arm Personal Invita2ons / Automated Invita2ons Required Inherently Iden2fied Traceable Comple2on Rates Customizable Invita2ons Ini2al invita2ons only available for the first survey of each arm Follow up surveys can be distributed through automated invites 44

45 Surveys Public Surveys Best Prac2ces Be Honest About: Time Required Number Of Ques2ons Number Of Possible Follow Up Surveys Be Brief Links Are Always An Op2on Keep It Simple When Able Collect: (For Future Follow Up Surveys) Mul2ple Unique Iden2fiers Monitor Responses Use No2fica2ons 45

46 Surveys Personal Invita2ons Best Prac2ces Validate s Beforehand Monitor Response Rates Send Reminders Manually Make 1 User Responsible Use Par2cipant Iden2fiers Be Prepared To Deal With Spam Filters Message Craying Follow Up A Subset Of Non- Responders Be careful with DAG s User should NOT Be Part Of A DAG For Best Results 46

47 Survey Queue Found in the Online Designer Populated by Forms & Events No Required 47

48 Survey Queue Survey Queue s Daisy- Chain your surveys Shorten Branching Logic Save & Return Op2on through Survey Queue Link Auto- Start Feature Define Paths based on Par2cipant Input Male vs Female surveys Follow Up Ques2ons Split Up Forms for Greater Flexibility Complex Studies Longitudinal Studies 48

49 Surveys Automated Invites Best Prac2ces Draw A Workflow Map Check Your Trigger Logic Make Sure You Use The Correct Cross Event Logic Check Your Time Delay Always Do A Test Run Be Prepared To Deal With Spam Filters Set Up A General From For Your Study Use Your Secondary of Ter2ary In Your Profile 49

50 Fire & Forget Example Survey Queue Choice A Intake Dona2on Form Public Survey Link Includes field Includes Choice Field Choice B Choice C Whole Blood Form Private Invita/on White Blood Cells Form Private Invita/on Plasma Form Private Invita/on Time Delay Time Delay Time Delay Follow Up Form Private Invita/on Automated Survey Invita/ons Follow Up Form Private Invita/on Follow Up Form Private Invita/on 50

51 Survey Confirma/on Found in Survey Sedngs Survey Reminders Up to 5 Reminders Surveys Auto- Canceled When Survey is completed Located in: Automated Invita/ons Par/cipant List Compose Survey Invita/ons

52 Data Integrity 52

53 Data Integrity Data Cleaning in Sta2s2cal Programs Usually more preferable REDCap Features: Valida2on of Text Fields Required Fields Data Quality Field Comment Log Data Resolu2on Workflow Data Comparison 53

54 Data Quality module Data Quality Module Found in the Applica2on List Quickly iden2fy Issues in your Project Pre- baked Rules Custom Rules Using Branching Logic Syntax Real- 2me Execu2on (Does not work in surveys) Example Find all records were [Gender] = Male and [Pregnant] = True Syntax: [gender(1)]= 1 and [pregnant]= 1 54

55 Data Queries Cross Over from CTMS* Soyware Manage the quality of your data 3 Op2ons: None Field Comment Log Comment Ability for Any Field in Any Record Linked to the User Not Supported in Survey Mode Exportable Data Resolu2on Workflow Open, View & Close Issues Issue Overview (List & Graphical) Compa2ble with Data Quality Rules * Clinical Trial Management System 55

56 Field Comment Log Text Balloon Symbol Next to Data Entry Fields Extensive Logging Works with History Widget (H Symbol) 56

57 Overview & Export Field Comment Logs are Found in the Applica2on List Exportable as a CSV File Filters Direct Links to Each Comment 57

58 Setup Data Resolu/on Workflow Found in the Project Setup Page In the Module Op2onal Modules and Customiza2ons Located in the Addi2onal Customiza2ons Buaon Select Data Resolu2on Workflow and Press Save Extensive Help Text and Video Links Available Go to User Rights to Hook Up Users with the Correct Rights User Rights 58

59 DRW Workflow Possible Ac2ons Opening Issues Viewing Issues Verifying Data Responding to Issues Commen2ng on Issues Closing Issues 59

60 DRW Overview Data Resolu2on Overview Found in the Applica2on List Resolve Issues Tab Resolu2on Metrics Tab 60

61 Learn How To Use REDCap INTRODUCTION TO REDCAP WHEN: (once a month) WHERE: South Lake Union See: haps:// class- schedule ADVANCED CLASSES See: haps:// class- schedule ONLINE VIDEOS & HELP REDCap Training Resources FAQ Supplemental Documenta2on ONGOING HELP iths_redcap@uw.edu (REDCap community list) iths_redcap_admin@uw.edu (REDCap administrators; last resort for help) 61

62 Future Advanced Classes Data Dic2onary - Impor2ng and Expor2ng Data User Rights Randomiza2on Best Prac2ces Advanced Longitudinal Studies & Surveys Schedule and Loca2ons will be on the ITHS website & will be announced in to users. hlps:// class- schedule 62