Table 3

Future patient-reported outcome guidance provision

	Trial protocol				Trial training				SOP
Suggested PRO-specific items of information13	RN	DM	TM	CPI	RN	DM	TM	CPI	RN	DM	TM	CPI
Purpose/importance of quality of life/patient-reported outcome data in trial	*		*	*	*		*	*
How to administer the questionnaire					*		*	*	*		*	*
How to input quality of life/patient-reported outcome data into the database						*				*
When to administer the questionnaire	*		*	*	*		*	*			*	*
What to do if there is missing data or in the event of scoring errors (eg, two answers provided instead of one, or reversed scoring)						*				*
What to do if participants write additional information on their questionnaires (or attach a letter)					*	*	*	*		*	*	*
Ethical issues associated with quality of life/patient-reported outcome use	*				*		*	*
How to deal with upset patients					*		*	*				*
Working with non-English language patients	*			*	*		*	*	*		*	*
How to support the participant to answer sensitive questions					*		*	*				*
How to collect quality of life/patient-reported outcome data without biasing the results					*		*	*	*		*	*
Collecting quality of life/patient-reported outcome data in different patient groups and/or settings					*		*	*
Relevance and reasoning behind individual quality of life/patient-reported outcome questions	*				*		*	*
How to deal with difficult situations					*		*	*				*