Workshop extraction for BP Targets
Contents
1. A Extract Study Data A 1 Key questions 1 On the New Study page select the first option One study created individually see item A in Figure 1 2 In the resulting Add a Single Study dialog appearing at the bottom of the page select Key Questions 1 and 2 by marking the appropriate check boxes see item B in Figure 1 3 Click Save and continue see item C in Figure 1 Figure 1 S RD SYSTEMATIC REVIEW DATA REPOSITORY Home New Study _ Project Blood Pressure Targets in CKD PROJECT SETUP Project Information New Study TEEF Studies may be added to your project individually or in batches Each study added must be associated with at least one extraction form Extraction forr Extraction Forms M managed from My Work or by Glicking the button labeled Create a New Data Extraction Form Mew Eu TSt Please specify how you would like to add dies to your project Questions 1 2 One study created individually A Manage Users Many studies created with a list of Pubmed Add a Single Study PROJECT STUDY DATA Study List w Which key question s are addressed in this study Complete List 3 Total d 1 What is the optimal blood pressure target for patients with CKD 15766995 v 2 What effect does proteinuria have on blood pressure in patients with CKD 12435255 PROJECT TOOLS View Summary Pinks Catara SRDR Training Module_ Cochrane_2012 A 2 Publication 1 Enter the following PubMed2. 300 1000 mg d 300 1000 mg d 300 1000 mg d 1000 5000 mg d 1000 5000 mg d 1000 5000 mg d Clear Selections SRDR Training Module_ Cochrane_2012 A 7 Outcome set up 1 On the Outcome Setup page click Add a New Outcome Name 2 In the resulting pop up select Kidney failure from the Outcome Title drop down list See Figure 10 3 In the Outcome Description enter ESRD 4 In response to What type of outcome is this select Categorical from the 3 options listed 5 Enter in the Units text box 6 In the textbox under Define Outcome Timepoints enter the following information Numeric Value or Name Time unit 3 years 7 Under Define Patient Populations Subgroups click Add A Subgroup 8 In the text box under Name enter Patients with baseline proteinuria 23g 24h 9 Again click Add A Subgroup and enter Patients with baseline proteinuria 1 3g 24h 10 Click Save SRDR Training Module_ Cochrane_2012 Figure 10 Add New Outcome Basic Setup Outcome Title Kidney failure Outcome titles in the menu above have either been added to the extraction form or are found in other studies within this project Use Other to specify a new outcome title Outcome ESRD Description What type of Categorical outcome is this Continuous OTime to Event Define Outcome Timepoints Numeric Value or Name Time Unit Median 1 6 years Add A Timepoint
3. Data Comparison Tool Data Export Tool File Repository Graphical Data View amp Stats Report Builder set inoRwaion User Manual and FAQ Feedback Note Coming Soon Publications Arm Det elines Enter Quality Dimensions Outcome Details Adverse Events Dimension Arandom unpredictable G What is the risk of selection bias biased allocation to interventions due to inadequate Low v assignment Comments generation of a randomized sequence Low Unclear High sequence 0 Examples of Post View adequate meth Adequate allocation What is the risk of selection bias biased allocation to interventions due to inadequate Low v concoaim be nt Comments concealment of allocations before assignment Low Unclear High Kol assignment 0 4 generated byan PostView ind Adequate For each main outcome or class of outcomes what is the risk of performance bias dueto 9 ___ _ ____ participant blinding knowledge of the allocated interventions by participants and personnel during the study lack Low v occurs if the index Comments of study participant and personnel blinding Low Unclear High e and control groups p V f ar w Adequate personnel blinding i Was the care provider blinded to the intervention Low Unclear High Pisses Sonate occurs ifthe index Comments and control groups p 0 Yes Z are SEG For each main outc
4. E in Figure 11 a Unselect Statistical test Odds Ratio OR and Standard Deviation b Select P Value c Click Save 7 From the drop down box select Low BP target vs Usual BP target 8 Enter 0 99 9 Click Save Table Data see item D in Figure 11 SRDR Training Module_ Cochrane_2012 11 Figure 11 lB 2 Comments 0 PostView Step 1 Choose the outcome and population to enter data for Kidney failure e a All Participants OR View Modify Existing Data Entries Note After successfully saving data to the table you may double click on the cell containing data to set footnotes and other options Outcome Kidney failure Description Population All Participants Descriptive Statistics Between Arm Comparisons Time Point Measure Low BP target Usual BP target Measure Low BP target vivs Usual BP target ov Percentage 23 20 P Value 0 99 3 years Remove N Analyzed 167 168 x eg f a Counts 38 34 Edit Measures c Edit Measures lt j Add Column Remove Comparisons save Table Data p 10 Now choose the subgroup for Patients with baseline proteinuria gt 3g 24h from the 2 drop down under Step 1 11 Enter the following data see Figure 12 Arm Low BP target Arm Usual BP target N Analyzed 58 62 Percentage nd nd Between Arm Comparison Low BP Target vs Usual BP Target P Value 0 81 Figure 12 Publications Arm Details
5. On the Design Details page fill in the following information see highlighted area in Figure 3 Q Question text Data to be entered 1 Follow up 3 y median 1 6y 2 Inclusion criteria of the Kidney function CrC lt 70 if proteinuria gt 3000mq d CrCl lt 45 if study proteinuria 1000 3000 mg d BP ND 3 Proteinuria exclusion UPE lt 1000 mg d if CrCl lt 45 mL min per 1 73m2 UPE lt 3000 criteria mg d if CrCl is 45 70 mL min 1 73m2 2 Please review your responses and click Save Data when finished 3 Click Next or move to the next tab Figure 3 Key Questions Publications Design Arm Details Outcome Details Adverse Ev nts Quality Study Design Details 1 Inclusion criteria for review RCTs and observational follow up reports of RCTs comparing blood pressure gt Comments 0 PostView 2 Follow up 3y median 1 6y years gt Comments 0 PostiView 3 Inclusion criteria of study Kidney function measured GFR or CrCl Study CrCl lt 70 if prot Clear Selections Comments 0 Post View 4 Proteinuria exclusion criteria UPE lt 1000 mg d if CrCl lt 45 mL min per 1 73m2 UPE lt 3000 mg d if CrCl is 45 70 Comments 0 PostView SRDR Training Module_ Cochrane_2012 A 4 Study Arms 1 Click Add Arm see item A in Figure 4 Figure 4 Project Information eee Editing Study Extraction Forms v NO PMID Untitled Vol Issue View Full List Guesions 12 Cr
6. in the Quality Guideline Used field see item A in Figure 15 Choose Good from the drop down list labeled Select Current Overall Rating see item B in Figure 15 Click Save Quality Rating when finished SRDR Training Module_ Cochrane_2012 16 Figure 15 Adjust Quality Rating Quality Guideline epc ea Used Select Current Good v Overall Rating Notes on this Rating Save Quality Rating Previous 6 Click Save Quality Rating You have completed the Extract Study Data exercise SRDR Training Module_ Cochrane_2012 17
7. 1 Click Add New Row 2 In the table that appears enter the following data see Figure 13 Title Treatment related adverse events Description Leave blank Low BP target Usual BP target Percent 4 2 P value leave blank leave blank Title SAEs Description Leave blank Low BP target Usual BP target Percent 23 17 P Value Leave blank Leave blank 3 46 Click Save Table Data Figure 13 Key Questions Publications Arm Details Outcome Details Adverse Events Quality Adverse Events Arm or Total Low BP target Treatment related v Usual BP target Low BP target SAEs Usual BP target Description Percent SRDR Training Module _ Cochrane 2012 Actions _ WDelete Adverse Event Comments 0 Post View _ UDelete Adverse Event Comments 0 PostView 14 A 11 Quality 1 Select the following Values from the drop down menus for each of the questions listed see Figure 14 1 What is the risk of selection bias biased allocation to Low interventions due to inadequate generation of a randomized sequence 2 What is the risk of selection bias biased allocation to Low interventions due to inadequate concealment of allocations before assignment 3 For each main outcome or class of outcomes what is the risk Low of performance bias due to knowledge of the allocated interventions by participants and personnel during the study l
8. Define Patient Populations Subgroups Name Description 11 Repeat steps 21 30 for the following outcome Outcome Title Mortality Outcome Description Leave blank What type of outcome is this Categorical Units Define outcome timepoints 3 years Subgroups None skip this step 12 Please review your entries and click Next or move to the next tab when finished SRDR Training Module _ Cochrane 2012 10 A 8 Outcome Details 1 In this section enter ESRD as the primary outcome 2 Click Next A 9 Outcome Results In this section you will be creating analysis tables based on the information that you have previously entered 1 From the drop down list labeled Step 1 Choose the outcome and population to enter data for select Kidney failure from 1 drop down see item A in Figure 11 And All Participants from the 2 drop down see item B in Figure 11 2 Within the table click Edit Measures see item C in Figure 11 a Unselect N Enrolled Counts and Standard Deviation b Select N Analyzed and Percentage c Click Save 3 Enter the following values into the table under the appropriate arms Arm Low BP target Arm Usual BP target N Analyzed 167 168 Percentage 23 20 Counts 38 34 4 Click Save Table Data see item D in Figure 11 5 Click on the blue box labeled Create Between Arm Comparisons 6 Within the table click Edit Measures see item
9. ID into the appropriate field 15738453 2 Click Retrieve see item A in Figure 2 The data fields below will be populated with information imported from PubMed Figure 2 Study List Complete List 1 Total J Primary Publications 5 halhes Although only a single publication may be marked as primary users may denote multiple secondary publications as associated with each extracted study Add New Study Enter a PubMed ID and press Retrieve to automatically populate the primary pn form n D pomeo 0 1573453 hanns A gt comment 0 Posiew View Summary Publish Externally Trial Title Data Comparison Tool Data Export Tool File Repository j Publication Title The effect of a lower target blood pressure on the progression of kidney disease long term follow ae caine up of the modification of diet in renal disease study J es Author s sarnak MJ Greene T Wang X Beck G Kusek JW Collins AJ Levey AS User Manual and FAQ Affiliation Division of Nephrology Tufts New England Medical Center Boston Massachusetts 02111 USA Feedback Journal Annals of internal medicine Note Coming Soon Waa nas Volume 442 Issue 5 Identifiers Add Publication Identifier Choose Identifier Type 3 Please review the imported information and click Save when finished 4 Click Next or move to the next tab SRDR Training Module_ Cochrane_2012 A 3 Design details 1
10. Outcome Details Results Adverse Events Quality Step 1 Choose the outcome and population to enter data for Kidney failure OR View Modify Existing Data Entries v UPE gt 3000 mg d Comments 0 PostView Note After successfully saving data to the table you may double click on the cell containing data to set footnotes and other options Outcome Kidney failure Description Population UPE gt 3000 mg d Descriptive Statistics Between Arm Comparisons Time Point Measure Low BP target Usual BP target Measure Low BP tar get vivs Usual BP target Percentage nd nd P Value 0 81 3 years Remove N Analyzed 58 62 Edit Measures Edit Measures Add Column Remove Comparisons Save Table Data SRDR Training Module _ Cochrane 2012 12 12 Repeat for subgroup Patients with baseline proteinuria 1 3g9 24h the following outcomes Arm Low BP target Arm Usual BP target N Analyzed 109 106 Percentage nd nd Between Arm Comparison Low BP Target vs Usual BP Target P Value 0 89 13 Repeat steps 1 9 for the Mortality outcome entering the following data Outcome Mortality Arm Low BP target Arm Usual BP target N Analyzed 167 168 Percentage 2 1 Between Arm comparison NONE no need to enter data SRDR Training Module_ Cochrane_2012 13 A 10 Adverse Events
11. Systematic Review Data Repository SRDR Training Example Case for Blood Pressure Targets Welcome to Systematic Review Data Repository SRDR In this module we will ask you to initiate a new project create an extraction form and extract data from one study The goal of this exercise is to familiarize new users with the SRDR by walking through the extraction of data from one sample study into a new systematic review project Please plan to devote 2 2 5 hours for this part of the training All materials for successfully completing this training are provided including step by step instructions and a sample study to extract Please read the notes below before beginning these exercises Notes Please use Firefox Google Chrome IE 7 8 9 or Safari browser when using SRDR Throughout this exercise information specifically designated for entry into SRDR Web forms during this exercise will be noted in italic blue Feel free to cut and paste these sections into the indicated fields For more detailed information on how to use the SRDR site please refer to the SRDR user manual which can be linked through the homepage SRDR Training Module_ Cochrane_2012 1 Log In 1 Go to http srdr dev heroku com 2 Log in using your email address as your username and the password cochrane 3 Once all logged in go to the My SRDR tab located under the SRDR banner 4 Locate the project entitled Workshop extraction 5 Click Add a Study
12. ack of study participant and personnel blinding Ja Was the care provider blinded to the intervention Other Please specify Yes 5 For each main outcome or class of outcomes what is the risk Low of detection bias due to knowledge of the allocated interventions by outcome assessment lack of outcome assessor blinding 6 For each main outcome or class of outcomes what is the risk Low of attrition bias due to amount nature or handling of incomplete outcome data 7 What is the risk of reporting bias due to selective outcome Low reporting 8 Are there other biases due to problems not covered in 1 6 No 9 Were all randomized participants analyzed in the group to Yes which they were allocated 10 Were the groups similar at baseline regarding the most Yes important prognostic indicators 11 Were co interventions avoided or similar Yes 12 Was the compliance acceptable in all groups Yes 13 Was the timing of the outcome assessment similar in all Yes groups 14 Are there other risks of bias If yes describe them in the No Notes 2 Please review your entries and click Save Table Data when finished SRDR Training Module_ Cochrane_2012 15 3 4 5 Figure 14 Study List Complete List 4 Total Author Undefined No PMID Wright JT Jr 12435255 Peterson JC 7574193 Ruggenenti P 15766995 gt gt Add New Study View Summary Publish Externally
13. ata SRDR Training Module_ Cochrane_2012 A 6 Baselines 1 Enter in the following data see Figure 9 Q Question text Data to be entered Data to be entered Data to be entered Arm Low BP target Arm Usual BP target Arm All Arms Total 1 Case of CKD leave blank leave blank ND excluded T1DM 2 Race leave blank leave blank ND conducted in Europe 3 Kidney function 36 34 leave blank 4 Proteinuria category leave blank leave blank 100 5000 mg d 5 Proteinuria criteria Mean UPE 2800 Mean UPE 2900 leave blank mg d mg d SD 2000 SD 1900 2 Please review your responses and click Save Table Data when 3 Click Next or move to the next tab Figure 9 Baseline Characteristics Enter your baseline characteristic information for each arm using the enfify fields below Remember to press the Save button before exiting the page 1 Cause of CKD Low BP target i o Usual BP target All Arms Total ND excluded T1DM Comments 0 Post View 2 Race Low BP target Usual BP target All Arms Total ND conducted in Europe gt Comments 0 PostView 3 Kidney function Low BP target 36 Usual BP target 34 All Arms Total measured GFR in mL min 1 73m2 I Comments 0 PostView 4 Proteinuria category Low BP target Usual BP target All Arms Total lt 300 mg d lt 300 mg d lt 300 mg d
14. eator aearley Key Questions Answered 1 and 2 Date July 02 2012 Extracting Data to Form Blood Pressure Targets KQs 1 2 Manage Users Study List Complete List 1 Total Study Arms Author Undefined No PMIDD gt There are no arms associated with this study Please use the form below to add a new arm Add New Study PROJECT TOOLS ha View Summary Publish Externally Data Comparison Tool Data Export Tool File Repository Previous Next gt 2 Inthe resulting pop up choose Low BP target from the drop down list see item A in Figure 5 In the arm description enter lt 130 80 3 Click Save see item B in Figure 5 The pop up will close and the newly selected arm information will now appear in the arms table Add New Arm Arm Title Low BP target x Arm titles found in the dropdown have been added to either the study extraction_form or are found in other studies within this same project Use Other to specify a new Arm title Arm lt 430 80 e a Description Participants Enrolled Enter the number of participants initially enrolled for this arm of the study You will have Isthisan Yes v intention to treat arm SRDR Training Module_ Cochrane_2012 4 Click the Add Arm button again This time you will enter an additional arm by selecting Other from the dropdown menu 5 Specify the arm as Usual BP target and under arm description enter DBP lt 90 See Fi
15. gure 6 6 Please review the arms information and click Next or move to the next tab when finished Figure 6 Add New Arm Arm Title Other Please Specify Usual BP target Arm titles found in the dropdown have been added to either the study extraction_form or are found in other studies within this same project Use Other to specify a new Arm title Arm Description DBp lt 90 Se 6 Both arms will appear in the list see Figure 7 Figure 7 c cnc ammen Study Arms Arm Title Arm Description Actions P Edit Arm 4 Low BP target Delete Arm gt Comments 0 Post View t Move Up Arm 2 Usual BP target Edit Arm GDelete Arm Comments 0 PostView Previous Next gt SRDR Training Module _ Cochrane 2012 A 5 Arm Details 1 Enter in the following data see Figure 8 Arm Target BP Achieved BP Low BP Target lt 130 80 130 80 Usual BP Target DBP lt 90 134 82 Figure 8 Key Questions Publications Arm Details Outcome Details Adverse Events Quality Arm Details Enter your Arm Detail information for each arm using the entry fields below Remember to press the Save button before exiting the page 1 BP measurements Low BP target Target BP Achieved BP Study lt 130 80 130 80 Clear Selections Usual BP target Target BP Achieved BP Study DBP lt 90 134 82 Clear Selections Comments 0 Post View Save Table D
16. ome or class of outcomes what is the risk of detection bias due to oe a bs knowledge of the allocated interventions by outcome assessment lack of outcome assessor Low v ocans IE a for g aiw Hi i Beal Low tinces HIMI Patient reported o Post View The number of For each main outcome or class of outcomes what is the risk of attrition bias due to amount T oyy a Darticpants WnO Comments nature or handling of incomplete outcome data Low Unclear High the study but did 0 4 if Post View notc z In order to have low G What is the risk of reporting bias due to selective outcome reporting Low Unclear High Low v eas Adye aa A bias the revi postView Are there other biases due to problems not covered in 1 6 Yes No No 4 e ary 4 PostView All randomized patients are i Were all randomized participants analyzed in the group to which they were allocated Yes Yes v reported analyzed Comments No Unsure inthe group they 0 were al Eesti es In order to receive a s Were the groups similar at baseline regarding the most important prognostic indicators Yes Yes v yes groups have Comments No Unsure to be similar at 0 baseline rega Post View This item should 2 Were co interventions avoided or similar Yes No Unsure Yes x desomol m s ory me j interventions ort je Post View The reviewer determinaec if tha Scroll to the bottom of the screen and enter EPC
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