Table 4.

ISOQOL-recommended PRO reporting standards for randomized clinical trials

Reporting standard category	Original CONSORT guidance 2010	Additional standards recommended for all studies with a PRO	Additional standards recommended for studies in which the PRO is a 1° outcome
		(Regardless of whether the PRO is a 1° or 2° outcome)
Title and abstract	1a. Identification as a randomised trial in the title		The title of the paper should be explicit as to the RCT including a PRO
	1b. Structured summary of trial design, methods, results, and conclusions	The PRO should be identified as an outcome in the abstract
Introduction, background, and objectives	2a. Scientific background and explanation of rationale		The introduction should contain a summary of PRO research that is relevant to the RCT
	2b. Specific objectives or hypotheses	The PRO hypothesis should be stated and should specify the relevant PRO domain(s) if applicable	Additional details regarding the hypothesis should be provided, including the rationale for the selected domain(s), the expected direction(s) of change, and the time points for assessment
Methods
Outcomes	6a. Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed	The mode of administration of the PRO tool and the methods of collecting data (e.g., telephone, other) should be described	A citation for the original development of the PRO instrument should be provided
	6b. Any changes to trial outcomes after the trial commenced, with reasons	The rationale for choice of the PRO instrument used should be provided	Windows for valid PRO responses should be specified and justified as being appropriate for the clinical context
		Evidence of PRO instrument validity and reliability should be provided or cited
		The intended HRQL data collection schedule should be provided
		PROs should be identified in the trial protocol; post hoc analyses should be identified
		The status of PRO as either a primary or secondary outcome should be stated
Sample size	7a. How sample size was determined		There should be a power/sample size calculation relevant to the PRO based on a clinical rationale (e.g., anticipated effect size)
	7b. When applicable, explanation of any interim analyses and stopping guidelines
Statistical methods	12a. Statistical methods used to compare groups for primary and secondary outcomes	There should be evidence of appropriate statistical analysis and tests of statistical significance for each PRO hypothesis tested	The manner in which multiple comparisons have been addressed should be provided
	12b. Methods for additional analyses, such as subgroup analyses and adjusted analyses	Statistical approaches for dealing with missing data should be explicitly stated, and the extent of missing data should be stated
Results
Participant flow (a diagram is strongly recommended)	13a. For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome	A flow diagram or a description of the allocation of participants and those lost to follow-up should be provided for PROs specifically
	13b. For each group, losses and exclusions after randomisation, together with reasons	The reasons for missing data should be explained
Baseline data	15. A table showing baseline demographic and clinical characteristics for each group	The study patients’ characteristics should be described, including baseline PRO scores
Outcomes and estimation	17a. For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95 % confidence interval)		The analysis of PRO data should account for survival differences between treatment groups if relevant
			Results should be reported for all PRO domains (if multi-dimensional) and items identified by the reference instrument (i.e., not just those that are statistically significant)
			The proportion of patients achieving pre-defined responder definitions should be provided where relevant
	17b. For binary outcomes, presentation of both absolute and relative effect sizes is recommended
Discussion
Limitations	20. All important harms or unintended effects in each group	The limitations of the PRO components of the trial should be explicitly discussed
Generalizability	21. Generalizability (external validity, applicability) of the trial findings	Generalizability issues uniquely related to the PRO results should be discussed, if applicable
Interpretation	22. Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence	The clinical significance of the PRO findings should be discussed
		The PRO results should be discussed in the context of the other clinical trial outcomes
Other information
Protocol	24. Where the full trial protocol can be accessed, if available		A copy of the instrument should be included if it has not been published previously