Table 1 Descriptive summary of some key data contained in the PROMOTION Registry ( http://promotion.gimema.it )

Name of Cooperative Group/s leading the study (if any)

Study location

Industry support

Primary endpoint/s

Difference between treatment arms in the primary endpoint (if any)

Age of patients

Gender of patients

Disease stage

Overall trial sample size

PRO sample size

PRO instrument/s used

Summary of PRO results

If statistically significant PRO difference exists, details of the domain/s of interest should be reported (e.g. symptoms only, functional aspects, global quality of life)

Summary of main clinical (other than PRO) results

PRO identification in the abstract

Statement of PRO hypothesis and its PRO domain

Description of the mode of administration of the PRO tool and the methods of collecting data

Electronic mode of PRO administration

Description of the rationale for choice of the PRO instrument

Citation of evidence of PRO instrument validity and reliability

Description of the intended PRO data collection

Statement of the status of PRO as either a primary or secondary outcome

Statement of the magnitude of the effect size (for statistically significant PRO results)

Description of statistical approaches for dealing with missing data

Statement of the extent of missing data

Flow diagram or description of the allocation of participants and those lost to follow-up for PROs specifically

Statement of the reasons for missing data

Description of the study patients’ characteristics including baseline PRO scores

Reporting of PRO outcomes in a graphical format

Discussion of the limitations of the PRO components of the trial

Discussion of the limitations of the clinical significance of the PRO findings

Methodology used to assess clinical significance

Discussion of the PRO results in the context of the other clinical trial outcomes

Selection bias

Performance bias

Detection bias

Attrition bias

Reporting bias