Table 1.

Summary of subthemes identified by the narrative synthesis process, organized by theme

Establishing need	Recognition of the importance of PROMs across all stakeholders: Highlight the potential clinical outcomes of PROMs Target evidence at all stakeholders Highlight recommendations from national/international organizations Identify research supporting the need for PROMs Capitalize on the increasing recognition of PROMs in other diseases Utilize the power of patient organizations to lobby policy makers
	Agreement that registries are a good way to collect PROMs: Registry-based collection may overcome some of the methodological limitations (e.g. larger samples, multiple time points, ability to account for interactions) Registries can be used as a sampling frame to target specific subgroups Provide evidence that registries are a cost-effective way to collect these data Highlight ability to describe equity of access to treatment/quality assurance Highlight ability to describe characteristics of responders/non-responders
Set up	PROM methodological issues Recognize methodological issues and how these will affect design and interpretation Recognize the importance of using properly translated and validated instruments for a population Consider undertaking a feasibility study when selecting the instruments Consider where the control data for measures came from
	PROM methodological expertise Involve experts at all stages of project design and development Provide staff with training in collecting, analysing and interpreting PROMs data
	National and international support Mandate or incentivise the collection of PROM data Obtain financial support from respected national and international organizations Coordinate expertise and infrastructure at a national level Understand laws and permissions in different countries with respect to PROMs
	Patient and public involvement Generate interest among the public and patients Involve patients in objective setting and the design of data collection and reporting Involve an international umbrella organization of patient associations where possible
	International standardization Agree on internationally standardized systems, definitions, data architecture and timings for data collection Aim for an internationally agreed core data set to enable international data pooling Design a system that can be easily adopted by subsequent countries wanting to join
	Stakeholder involvement in objective setting Involve all stakeholders in objective setting and design Aim to reach consensus of key objectives at/before the design stage Define relationships and responsibilities at the beginning Avoid having too many stakeholders
	Practical considerations including resources Obtain sufficient funding for staff, equipment etc Minimize the burden of administration at the clinic level Provide clear guidelines and training for staff administering PROMs Work out the most cost-effective way of collecting PROMs Consider using a PROM registry that is not disease specific so resources can be shared Set realistic timescales
	Design and ongoing evaluation/modification Understand current data collection status of existing registries Offer a range of modes of completion for questionnaires, including paper and electronic. Align the data collection to objectives set by stakeholders Ensure design has capacity for flexibility as the project develops Set criteria for evaluation of project in advance Aim to minimize the burden to patients Consider dividing up the project into a number of work packages, each with its own lead
Maintenance	Technological and information governance issues Ensure lack of familiarity with technology does not limit participation Ensure technology has the capacity for flexibility over time Consider issues of data security and information governance Establish and address the legal and ethical constraints of the country/state Develop a coordinated IT infrastructure Consider availability of technology across different participating countries Maintain database so that patient information is up to date Obtain legal advice on the data sharing agreements that may be necessary Get the technology working before rolling it out-slow technology can be a barrier
	Useful high-impact output Maintain interest by maximizing published output in a range of formats Target different stakeholder group with outcomes of PROMs work Present patient-level data in a readily understandable format Highlight the direct benefit to patients from participation Use ongoing nature of data to ensure frequent analysis and dissemination Data should aim to help improve patient care Make data as freely available as possible within the constraints of confidentiality
	Maintaining trust/faith in the data Ensure methodological rigour to maintain trust Be aware of the sensitivity of centres to publication of data that reflects poorly on their performance Ensure objectives and evaluation are transparent and set by stakeholders and not any group for example with a vested interest Be aware that PROMs viewed more positively if presented as a care management tool Report characteristics of responders and non-responders