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

From: Overcoming barriers to the implementation of patient-reported outcomes in cancer clinical trials: the PROMOTION Registry

Basic Study Characteristics 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 Methodology and Analysis 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
Study Validity Selection bias
Performance bias
Detection bias
Attrition bias
Reporting bias
  1. Abbreviation: PRO (Patient-Reported Outcome).
  2. Legend: the following aspects are reported for descriptive purposes only. This is not a comprehensive list of all data contained in the PROMOTION Registry.