Increased awareness of and interest in patient involvement in HTA has led to calls for guidance around ‘best practice’ from many stakeholder communities, including those comprising patients and families. In response, the PCIG produced HTAi Values and Quality Standards for Patient Involvement in HTA. These values and standards, shown in table 3, were developed through an international 3-round Delphi process. They can be applied or developed to suit the clinical guideline setting. Table 3 HTAi Values and Quality Standards for Patient Involvement in HTA (2014) Values– Relevance: Relevance refers to the fact that patients and families hold important knowledge and a unique perspective, which can only be obtained through ‘lived’ experiences with a particular disease or condition. Both are essential to the generation of HTA evidence that is comprehensive and captures the value of a technology to those directly affected by its use. – Fairness: Fairness relates to the need to create opportunities for patients to be engaged in the HTA process that are equivalent to those already available to other stakeholder communities, such as healthcare providers and industry. Therefore, patient involvement is viewed as a basic ‘right’ of patients and families affected by HTA-informed decisions.– Equity: Equity is often defined as the absence of avoidable differences among groups within a population. Patient involvement in HTA helps to ensure that HTA evidence reflects an in-depth understanding of the diverse needs of various groups of patients. This information can reduce the risk of creating inequities in health status when healthcare systems are required to distribute health resources fairly among all users.– Legitimacy: Legitimacy refers to the acceptance of HTA-informed recommendations or decisions by affected individuals through appropriate patient involvement. Engagement of patients and families in HTA contributes to the transparency, accountability, and credibility of HTA-informed decision-making processes, which, in turn, enhances their legitimacy.– Capacity building: In general, adoption of formal mechanisms for involving patients in HTA not only addresses existing barriers to their engagement, but also provides an opportunity to build capacity for patients, families and HTA organisations to work together in a productive way.Quality Standards: General HTA process1. HTA organisations have a strategy that outlines the processes and responsibilities for those working in HTA and serving on HTA committees to effectively involve patients. 2. HTA organisations designate appropriate resources to ensure and support effective patient involvement in HTA. 3. HTA participants (including researchers, staff, HTA reviewers and committee members) receive training about appropriate involvement of patients and consideration of patients’ perspectives through the HTA process. 4. Patients and patient organisations are given the opportunity to participate in training to empower them so that they can best contribute to HTA. 5. Patient involvement processes in HTA are regularly reflected on and reviewed, taking account of the experiences of all those involved, with the intent to continuously improve them.Quality Standards: Individual HTAs The remaining 5 standards apply to specific steps followed during the assessment and formulation of a recommendation or decision about a particular health technology. 6. Proactive communication strategies are used to effectively reach, inform, and enable a wide range of patients to participate fully in each HTA. 7. Clear timelines are established for each HTA with advance notice of deadlines to ensure that appropriate input from a wide range of patients can be obtained. 8. For each HTA, HTA organisations identify a staff member whose role is to support patients to contribute effectively to HTA. 9. In each HTA, patients’ perspectives and experiences are documented and the influence of patient contributions on conclusions and decisions are reported. 10. Feedback is given to patient organisations who have contributed to an HTA, to share what contributions were most helpful and provide suggestions to assist their future involvement. In developing these values and quality standards, the PCIG stressed that patient involvement should be seen as a journey. Every HTA body starts in a different place and the high requirements of the values and quality standards are intended to encourage them to take a step on the journey to involve patients in their processes. Those who already do, should evaluate what they do and make improvements. Since their publication in 2014, several HTA bodies have endorsed the Values and Quality Standards and used them to review their own processes. For example, CADTH has used it for their Framework for patient engagement in health technology assessment (2019).