Results
The aforementioned steps aimed at assessing the comprehensiveness of
outcome reporting in obstetric trials, culminated in the COR Tool, an
Excel Workbook with 54 sheets allowing for assessment of up to fifty
clinical trials within the setting of a systematic review. The user
begins with the sheet named ‘Master Sheet’, where Steps 1 to 4 are
completed as detailed above. The user interface for Steps 2 and 3 of the
‘Master Sheet’ can be seen in Figure 1, and the user interface upon
completion of Step 4 determining how to measure outcomes, is shown in
Figure 2. All information required by researcher aiming to select
outcomes for a trial, would be available on the interface shown in
Figure 2.
A systematic reviewer, critical appraiser, or clinician seeking to
assess comprehensiveness of outcome reporting in a said number of
trials, would need to continue further, by assessing the
comprehensiveness of outcome reporting for each trial, on separate
programmed sheets, within the tool’s workbook. As the data is entered
onto individual sheets, it is automatically collated to generate the
heatmap output found under the sheet labelled, ‘COR Tool’. Figure 3 is
an example of what this heatmap might look like, following the
assessment of twenty mock trials, and provides a visual description of
the comprehensiveness as follows:
- Studies 1 – 3 with most cells coloured in blue, when not grey,
indicate that the studies have comprehensively reported outcomes in
all relevant outcome areas, for both mother and fetus.
- Studies 4 – 6 with yellow cells to the right of both panels,
representing maternal and fetal-neonatal outcomes, indicate that
although these trials report outcomes relatetd to both, mother and
baby, still fail to report patient-centred outcomes related to outcome
areas of functioning, delivery of care or resource-use.
- Studies 7 – 17, which have varying numbers and shades of blue in the
first (maternal) panel, represent clinical trials that solely report
maternal outcomes, with varying levels of completeness.
- Studies 18 – 20, which have varying numbers and shades of blue in the
second (fetal-neonatal) panel, represent clinical trials that soley
report fetal-neonatal outcomes. Cells in grey indicate outcome areas
that are not relevant to a particular study, for example,
fetal-neonatal functioning.
- The last four columns, in shades of burgundy, provide further
information with regard to the use of a core outcome set (when
available), inclusion of intermediary laboratory markers, and whether
conclusions drawn in the manuscript and abstract are in keeping with
the outcomes studied in the trial. The latter provides additional
context, by highlighting for example, that although the last three
studies do not report any maternal outcomes, the conclusions they
draw, appropriately represent this limitation.
This example shows how the heatmap, by providing a visual summary of the
comprehensiveness of outcome reporting, can, along with the Cochrane ROB
or similar tools, add an important dimension to the appraisal of trials
for purposes of systematic reviews.