Using GRADEpro to create a Summary of Findings table for a Cochrane systematic review

Using GRADEpro to create a Summary of Findings table for a Cochrane systematic review

Authors of Cochrane systematic reviews can use GRADEpro to create a Summary of Findings (SoF) table. GRADEpro will help you to create the table and to use GRADE to grade the quality of the evidence in the review. Because GRADEpro is a separate software from RevMan, you will need to import your RevMan file into GRADEpro, create and save the table in GRADEpro, and then import that table into RevMan.

GRADEpro is set up to make it easy to fill in the 3 key parts of a SoF table:

i. information about the review (top part of SoF)

ii. GRADE of the quality of evidence (last column and footnotes of the SoF) iii. summary of the statistical results (first columns of the SoF)

If you need any help while creating your SoF, there is a HELP file. You can access it directly from the GRADEpro toolbar, or by hovering over sections of the GRADEpro screen and clicking directly on that word or area.

Steps to create a Summary of Findings Table

An example of a Summary of Findings table can be found at the end of this document and it is used in the steps below.

1. Download GRADEpro at /gradepro/GradeProSetup.exe.

2. Before starting your SoF, finish the statistical analyses in RevMan and save your RevMan file

on your computer.

3. Open GRADEpro. Choose ‘New profile”. Name and save the new file.

4. At this point there is an empty GRADEpro screen. Import your RevMan file. From the

<File> menu, choose <Import From > Review Manager file> and select your RevMan file.

5. All data from the meta-analyses in the RevMan file were imported. GRADEpro structures that information similar to how it is

structured in RevMan in the left sidebar. You will first see each comparison. Click on each comparison and expand the tree to see the outcomes that were imported.

5. Choose the main comparison for which you will create the main SoF in your review. Click

on this comparison. You will need to edit and fill in the details about the comparison. First choose the best question format for your review by opening the dropdown box beside

‘Format’. In this example, the best format is “should [intervention] vs [comparison] be used for [health problem]? Then fill in all of the boxes for the ‘PICO” - intervention, comparison, population, etc. What is entered in to the boxes is what will show in the top section of the SoF table.

NOTE: Ensure that the table format displayed at the bottom of the screen is a Summary of Findings Table (not another type of table). Choose <View> from the top menu and select <Summary of

Findings Table>.

6. Create, move, or delete outcomes. All outcomes that have meta‐analyses were imported,

but you will need to decide on the 7 outcomes to include in the SoF that are important to decision making (e.g. patient important outcomes).

a. To delete an outcome, right click and choose delete.

b. To move outcomes to arrange in order of importance, click and drag and drop it. c. To add an outcome (e.g. an outcome for which there was no meta-analysis but it is

still an important outcome to include in the SoF), click on the main comparison,

choose <add outcome>, and type in the name of the outcome.

7. Edit outcome information. Click on an outcome. For each outcome there are 2 screens: 1)

‘summary of findings’ screen for numerical data; 2) ‘quality assessment’ screen to GRADE the evidence. Switch between the screens using the box midway down the right hand of the screen “Go to summary of findings” and “

Go to quality assessment”.

8. Start by filling in the information about the type of outcome on the Quality of Assessment

screen. Edit the outcome name so that it is understandable to a general audience. Fill in how the outcome was assessed, number of studies contributing to that outcome, etc. This information is filled into the SoF table under the outcome column.

NOTE: You will need to fill in the type of study (e.g. randomised trials) to see the GRADE quality of assessment criteria.

9. Assess the quality of evidence for the outcome by downgrading or upgrading evidence

according to the GRADE criteria. For example, you will decide whether there was ‘no’ inconsistency in the evidence, ‘serious’ or ‘very serious’ inconsistency. Enter footnotes to explain your judgments (typcially when downgrading).

the terms and click on it to link directly to HELP.

10. Now fill in the numerical data for each outcome. Switch to the Summary of Findings screen

by clicking on the “Go to Summary of Findings” box midway down the right hand side of the screen. Confirm the data that were imported and other data manually.

a. For continuous outcomes, enter data such as assumed risk (baseline scores), units of

scale, and range of scores on the scale. To enter comments, click on the comment

box in the SoF display and fill in the pop up box and save.

b. For dichotomous outcomes, enter data for the assumed risks (baseline risks). It is

up to you what baseline risks you display (low, moderate/median, high). Select the box and fill in the percent. You may want to present risks as ‘out of 100’. You may also want to attach a footnote to the reasoning behind your choice of baseline risks.

11. Repeat #8 to #11 for all outcomes in the SoF table.

12.

13. If, there is more than 1 comparison of importance in the review, you can create another SoF

table.

14. When satisfied with the table, you need to save the file. Choose <File> <Export as > Review

Manager SoF>. Name the file (it will be a *.sof file). This file can be imported into RevMan. Alternatively you can save the file to another format if desired, but it cannot be imported into RevMan.

15. To import the Summary of Findings (*.sof file) into your RevMan review, open your RevMan

file. In the left hand panel expand <Tables>, click on <Summary of Findings Table>. In the right hand panel, click the box <Add Summary of Findings Table> and follow the wizard.

August 2011

Self management for patients with chronic obstructive pulmonary disease Patient or population: patients with chronic obstructive pulmonary disease Settings: primary care, community, outpatient

1

Intervention: self management Comparison: usual care

corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; OR: Odds ratio;

GRADE Working Group grades of evidence

High quality: Further research is very unlikely to change our confidence in the estimate of effect.

Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.

Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.

Very low quality: We are very uncertain about the estimate.

Self-management is a term applied to any formalized patient education programme aimed at teaching skills needed to carry out medical regimens specific to the disease, guide health behaviour change, and provide emotional support for patients to control their disease and live functional lives. Of the 14 studies, there were four in which the education delivery mode consisted of group education; nine which were individual education and one study which was written education material only. In six studies the use of an action plan for self-treatment of exacerbations was assessed. 2

Seven other studies were not pooled and some showed non-significant effects. 3

No allocation concealment in 1 study. Incomplete follow-up. 4

Sparse data. 5

Different definitions of exacerbations used and studies could not be pooled. 6

The low and high risk values are the two extreme numbers of admissions in the control groups from two studies (8% was rounded to 10% and 51% to 50%). 7

Two studies with very severe COPD patients weighted heavily in meta-analysis. Therefore, there is some uncertainty with the applicability of effect to all risk groups. 8

Unexplained heterogeneity.

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