Setting up the template

In your protocol you will have defined which specific outcomes you are interested in investigating e.g. “Quality of life”. You can add these primary and secondary outcomes to your template.

For each outcome you can add timepoints of interest. These can be generic e.g. End of treatment, Last follow up. Or specific e.g. (28 weeks, 8 weeks). If timepoints aren't relevant for your outcomes, you can add a placeholder such as "-" or "N/A".

All outcomes and timepoints you add to this section will appear for all studies, allowing you to collect consistent data across studies. You can update the template at any time throughout the data extraction process.

 

Adding outcomes and timepoints

Outcomes can be added to the template. When adding an outcome, three required fields need to be completed:

  • Name - the outcome name as defined in the protocol or review plan
  • Type - whether the outcome is continuous, dichotomous or qualitative
  • Timepoints - the timepoints of interest to the outcome such as baseline, end of study, or specific durations (e.g. Baseline, 12 weeks, end of study as shown).

When extracting outcome details from a study, you’ll have the ability to select which outcomes and timepoints are included in that study. You’ll also be able to add an optional reported name for the outcome and reported time for each timepoint. Additionally, you can add multiple sub-outcomes under each template outcome to capture all relevant measures reported in the study.

 

Outcome details

The template includes a range of default fields, which can be un-selected in the template. These fields allow you to capture information on how each outcome was defined and measured in a study.

  • Outcome reporting - dropdown options to capture how fully the outcome is reported
  • Scale - to capture details about the type of scale used to measure the outcome
  • Range - the upper and lower limits of the scale
  • Unit of measurement - for example days, centimetres, litres
  • Direction - whether higher or lower scores indicate improvement
  • Data value - whether the data are change from baseline or endpoint scores
  • Notes

 

Extracting data from studies

When extracting data from a study, the 1st Reviewer can select which outcomes and timepoints are included in the study. Optionally you can add a reported name linked to the template-defined outcomes and timepoints.

For example:

  • The review outcome “Quality of life” was reported in the study as “SF-36 physical function score”
  • The review timepoint of “End of treatment” was reported in the study as “8 weeks”.
  • When you select an outcome, an outcome details table will appear allowing you to collect information on how each outcome was defined and measured in the study.

 

Note that you can add multiple sub-outcomes linked to the template-defined outcomes. This is useful if multiple specific outcomes are reported for the same outcome category e.g. both SF-36 and AQLQ scores for quality of life, or multiple quality of life indicators like physical health and mental health etc.

When you select an outcome, tables will automatically be added to the results data section, allowing you to collect result data (quantitative or qualitative).

The data formats shown (e.g. Mean, SD) can be edited by the 1st Reviewer during extraction of a study. 

If you are completing a Cochrane review or you created a data extraction template before the 5th of November you will be using the old version of the results data tables.

If you are using the old version of the results tables, you can do this by clicking the edit icon in the top left of an outcome table, as circled below. Custom data formats can also be added and they can be anything you like, to allow you to capture qualitative results. If you edit the data formats shown on the result data tables, this will only change the tables for that study.

If you are using the new version of the results tables (image shown below), you can change the default measures by selecting the dropdown on the columns or by adding and deleting columns.

Only the 1st Reviewer can edit the results data table. If you are the 2nd Reviewer and want to edit the outcome table you can check who the 1st Reviewer is on the study list and ask them to make any relevant changes. If needed, you can switch the 1st and 2nd Reviewer by clicking "Manage reviewers" and the data they have collected will be transferred along with the reviewer.

 

Help for setting up each section of the template

Below are step by step guides providing tips on how to set up your template for each section: