Table 1.

Definitions

Concept	Description
Patient engagement	The effective and active collaboration of patients, patient advocates, patient representatives and/or carers in the processes and decisions within the medicines lifecycle, along with all other relevant stakeholders when appropriate1
Patient partner	A patient, patient advocate, patient representative and/or carer who contributes to any level of patient engagement activities; this can also be substituted for other terms such as patient contributor82
Research participant	A person who participates in human subject research, also called a subject, study participant or volunteer of an experiment or trial
Society	Includes all members of the public and patients who use health‐care services
Research priority setting	Any process aimed at constructing priorities or agendas for health research and medicines development, to raise awareness and change the way research funding is allocated
Design of clinical trials	Any process aimed at the development or design of clinical trials for medicines development at any stage of that process. One example is changes made to inclusion and exclusion criteria for trial participants
Early dialogues with regulators and Health Technology Assessment (HTA) bodies	Any process in which medical technology developers communicate with regulatory bodies and/or HTA bodies prior to health technology assessment. Early dialogue can happen only with regulators (eg scientific advice), jointly with regulators and HTA bodies (to discuss data requirements to support decision making on marketing authorization and reimbursement simultaneously) or only with HTA bodies (eg EUnetHTA multi‐HTA dialogues)
Benefit	An advantage of engagement for research and development and stakeholders involved
Costs and challenges	The expenditure and/or effort of engagement for research and development and the stakeholders involved
Outcomes	Decisions made and things produced as a direct result of patient engagement practices. One example is changes made in the design of a clinical trial resulting in a more relevant and appropriate research protocol. Outcomes may lead to impact on research and development
Impacts	Broader effect of outcomes, both positive and negative, of patient engagement. Impact may be direct or indirect, intended or unintended. For example, this may include study quality benefits such as improved recruitment and retention of study participants
Value	The benefits of patient engagement (in relation to the direct and indirect costs) for individuals and organizations involved
Monitoring	The formative evaluation of patient engagement practices in order to strengthen them
Evaluation	The ‘systematic acquisition and assessment of information to provide useful feedback about …’ patient engagement practices.83 Summative evaluation examines the effects of patient engagement practices on various measures including outcomes, impact and cost‐benefit
Criteria	Dimensions or parameters used for evaluation. These need to be translated into measurable entities called ‘indicators’ and indicators are measured with ‘metrics’
Indicator	Qualitative or quantitative measure that provides a means of expressing achievement of a goal or ascertaining the consequences of a specific change. Quantitative indicators are reported as numbers, such as rates of change and ratios. Qualitative indicators are reported as words, in statements, paragraphs and reports84
Metrics	Observations based on standardized data sources or agreed techniques for gathering information. Metrics could consist of an agreed set of quantitative and/or qualitative indicators to measure evaluation criteria, with a set of agreed methods/tools to collect this information
Methods	Ways to collect information for monitoring and evaluating the outcomes and impact of patient engagement practices, for example quantitative, qualitative or mixed methods
Tools	Instruments to collect information about patient engagement practices. For example, interview guides, questionnaires, log sheets and observation forms are all tools