Experts were selected through the FAHRE partners, with balance for individual characteristics, and reported using a standardised template.
In addition, the MRIs were reported using a standardised protocol by a radiologist who had previously demonstrated consistency in evaluating spinal pathologies and was blinded to both the treatment group and the clinical outcome, however, in other settings and with other MRI variables the reliability could vary.
For 2351 cases, BCFR study pathologists ascertained ER and PR status from patient tumour tissue using immunohistochemistry (IHC) and/or pathology reports using a standardised protocol and pathology reporting forms.
Results of the meta-analysis will be reported using a forest plot of the overall standardised mean difference.
For continuous data, the effect size of trials will be reported using a mean difference where trial outcomes are reported using a consistent measure, or a standardised mean difference where outcomes across trials report the same outcome using comparable measures.
Two authors (KEAB, NKJA), not blinded to the source of the reports, used a standardised data abstraction form to independently abstract data regarding study methods (randomisation, allocation concealment, cointerventions, blinded outcome assessment, completeness of follow-up, and adherence to the intention to treat principle).
Additional information (including histology) was sought from physicians for all reported cancers, using a standardised proforma.
Incidents were reported and categorised using a standardised format.
Analysis reports were analysed using a standardised procedure that followed the steps of the ORION method.
Changes in HRQL (e.g. pain relief) should preferably be reported directly from patients, using a standardised instrument such as EQ-5D, if possible.
