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
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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
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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
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PROM methodological expertise
Involve experts at all stages of project design and development
Provide staff with training in collecting, analysing and interpreting PROMs data
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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
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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
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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
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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
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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
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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
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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
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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
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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
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