The Scottish Medicines Consortium (SMC) patient group submission process includes a written submission of patient experience evidence from Patient Group Partners (PGPs). To maximize the relevance and quality of information included in submissions, the first draft is reviewed by the Public Involvement Team and feedback is provided. The submission is then amended by the submitting PGP before final submission.

Upon receiving a new written patient group submission, the Public Involvement Team reviews it and provides feedback highlighting any evidence gaps and areas where wording could be amended to strengthen the patient voice. The draft submission is then amended by the submitting PGP, with support from the SMC reviewer. Once finalized, the submission is collated into the body of evidence used by the SMC Committee members to assess a new medicine. The satisfaction of participating PGPs is continually assessed by an online survey. During the 2021 to 2023 period, the SMC received 232 patient group submissions, with 77 percent being amended and strengthened after receiving feedback.

The feedback and collaboration on amendments to draft submissions has improved the quality of patient experience evidence submitted to the SMC by PGPs. PGPs value their draft evidence being reviewed by the SMC Public Involvement Team prior to final submission. This approach resulted in high levels of trust in and satisfaction with how the SMC involves patient representatives in medicine assessments. In 2022, 89 percent of the 28 PGPs surveyed were very satisfied and 11 percent were satisfied with the support provided during the submission process.

Evaluation of the SMC’s formal process to provide input and feedback on draft written patient group submissions demonstrates high levels of satisfaction with how the SMC works in partnership with PGPs. This approach has strengthened written evidence of patient experiences for SMC assessments. Furthermore, it helps to build and maintain a partnership approach in how the SMC works with PGPs.

Over the past 10 years, the Scottish Medicines Consortium (SMC) has strived to strengthen the involvement of patients and citizens in its work and improve public understanding of health technology appraisal (HTA). A series of innovations have been brought in since 2014 to increase levels of engagement and satisfaction of participants. This work describes these and their impact.

SMC has introduced numerous transformational changes since 2014. Innovations include a new Patient Group Partner (PGP) registration system, strengthened patient group submission process, participation of patient representatives at Patient and Clinician Engagement (PACE) and SMC Committee meetings, embargoed early release of SMC decisions to PGPs, provision of Summary Information for PGPs (from submitting company), and revised role of public representatives. The creation of the SMC Public Involvement Network Advisory Group has underpinned these achievements, as has the provision of comprehensive one-to-one support, information and education to PGPs. SMC has continually evaluated the satisfaction of participating PGPs using an online questionnaire.

There has been a sustained increase over the past 10 years in both the number of patient groups engaging with SMC and the number of PGP submissions that SMC receives. Adopting a continuous improvement approach, working in partnership with PGPs and public representatives, has helped SMC to ensure that stakeholders in the HTA process are effectively engaged and informed about the HTA of new medicines in Scotland. Surveys of public involvement in SMC consistently show an extremely high level of satisfaction from PGPs who work with SMC, with most PGPs consistently rating their experience of working with SMC as excellent.

Over the past 10 years, SMC has strived to strengthen how it involves citizens and patient representatives in HTA. Various innovations and a continuous improvement approach have helped to ensure that there are high levels of satisfaction and understanding of the HTA process from patient groups who engage with SMC. This is underpinned by a partnership approach to working.

Since 2018, the Scottish Medicines Consortium (SMC) has published a plain English summary for each health technology assessment (HTA) decision called Decision Explained (DE). This provides clear information to patients, Patient Group Partners (PGPs), and the public about what SMC’s decisions mean for them. The DE document was evaluated and updated in 2023 to ensure it continues to meet this purpose.

The evaluation consisted of two components. All (186) registered PGPs were invited to complete an online five-question survey focusing on the use of the DE document. This included readership, language, and SMC decision-making transparency. A separate focus group for public representatives took place, discussing design, accessibility, and content. Identical sample DE documents were used for both groups for consistency. Survey responses were collated and analyzed. Focus group responses were analyzed using thematic analysis. The DE document was revised, and the new version was considered for implementation by SMC’s Public Involvement Network Advisory Group.

Survey respondents (n=20) found the DE document helpful or very helpful in improving understanding of SMC advice. Some commented on complex language and information about how the medicine works being irrelevant. The focus group commented on excess information and favored simplified content and structure. Analysis of both sets of research data resulted in several recommended changes. These included the decision statement being moved to the start of the document, the language being simplified, and the section on how a medicine works being removed. Revised documents including these changes were prepared and were reviewed and approved by the SMC’s Public Involvement Network Advisory Group.

Published plain English explanations are helpful for improving patient and public understanding of HTA decisions for new medicines. It is important this information is concise, relevant, and aligned to accessibility good practice. The recent review of the SMC DE documents led to changes that help to ensure they meet the needs of stakeholders.

The Scottish Medicines Consortium (SMC) conducts early health technology assessment (HTA) of new medicines, the primary output of which is a document referred to as the Detailed Advice Document (DAD). This comprises an overview of all data considered on the clinical and cost-effectiveness of the medicine, as well as the input from patient groups (PGs), patients, and carers. In 2020, SMC commenced a stakeholder evaluation of the DAD including a workshop with PGs and public partners (members of the public who volunteer with SMC) to explore the potential for using the DAD more widely.

PGs and public partners, all having significant experience of engaging with SMC, participated in the workshop. Feedback was gathered using virtual post-it notes, collated and analysed for key themes. We also gathered oral feedback from participants. Sample DADs were distributed for two medicines recently appraised, one of which included a Patient and Clinician Engagement (PACE) meeting. These were chosen because they reflect different aspects of public and patient involvement at SMC, including how this is presented in the DAD.

Overall, the workshop participants (n=7) recognised the DAD was a useful document for the clinicians who are its primary audience. Its language was perceived to be challenging, including complex information that is not accessible to a wide audience and may only be fully understood by those with a good understanding and knowledge of HTA. This was a key barrier to using the DAD more widely, in particular the health economics information. Suggestions for broadening the audience of the DAD included summaries of key points and an introductory section clarifying the purpose of the DAD and its intended audience, along with signposting to the plain language summary produced by SMC. These will be implemented where possible.

Improving how SMC communicates decisions to patients and the public, by working in partnership with these stakeholders, will help strengthen public involvement throughout the HTA process.

The Scottish Medicines Consortium (SMC) provides advice on which new medicines should be accepted for routine use by the NHS in Scotland. To help increase the accessibility of the advice, SMC produces public information summaries, which have been published on the SMC website since 2018. We conducted an evaluation to investigate if the public summaries are achieving their purpose and subsequently help inform improvements from a user perspective. The objectives were to determine how the public summaries are being used; what users like and what could be improved; and if they have achieved a greater understanding of decisions.

The first stage of the evaluation involved surveying patient groups (organizations that represent the interests of patients, families and carers) to investigate how they use the public summaries. We then conducted workshops with patient groups and Public Partners (members of the public that volunteer with Healthcare Improvement Scotland) to gather perspectives on the content, language and layout of a selection of public summaries.

The survey responses (n = 14) illustrate that the public summaries are being used in a variety of ways. The majority (n = 10) of patient groups reported using the public summaries to help explain SMC decisions to the people they support.

The workshops highlighted that participants found the public summaries clear and helpful. In general, patient groups felt the level of detail and language used in the public summaries improved their understanding of SMC decisions compared to other sources of information, such as the press release or Detailed Advice Document.

There were a number of suggested improvements, including changing the layout (so the SMC decision appears first) and providing definitions for some technical terms. Where actionable, these recommendations have been implemented.

Working in partnership with patient groups and Public Partners has enabled SMC to further strengthen public summaries, and patient engagement more broadly. Improvements have ensured that SMC's decisions are communicated clearly, helping to increase accessibility.

The Scottish Medicines Consortium (SMC) encourages patient group (PG) representatives to participate in the decision-making committee meetings, answering questions from committee members and providing points of clarity throughout discussions if required. In a continuous improvement approach the process and the participant experience is continually evaluated to monitor impact and emerging themes.

The interactions between committee members and PG representatives are recorded in writing by the public involvement team to monitor the questions or points of clarity raised. These interactions were analyzed using thematic analysis to look for emerging themes. Following the meeting, PG representatives are invited to complete an online survey on their experience of working with SMC.

From July 2017 to October 2018, 36 PG representatives have attended committee meetings for the discussion of their submission. Committee members asked 17 PG representatives to contribute. Key themes that have emerged to date include insight into the impact of living with the condition on quality of life and how a new medicine may affect this. Survey feedback has been positive with participants reporting that patient engagement has been strengthened, and that the patient voice is heard, valued and supports committee members in making fully informed decisions. PG representatives expressed a willingness to participate again. Feedback also highlighted that the preparatory support offered to PG representatives by the public involvement team is highly valued.

Patient group participation in committee meetings has been received positively by PG representatives. They report that discussions relating to quality of life impact of medicines on patients and carers better reflect the lived experience, enriching committee's deliberations. This demonstrates SMCs commitment to openness and transparency and has strengthened patient engagement in our processes.

Transparency of processes and decision making is important to the Scottish Medicines Consortium (SMC). An independent review of access to new medicines in Scotland in 2016 recommended that SMC should review its communication of decisions with a view to achieving greater transparency. SMC therefore began to develop plain English summaries of advice on each new medicine.

A multi-stakeholder approach was adopted to develop the summary documents, with patient groups involved. Firstly, a review of communications for the public from other HTA organizations was conducted. The public involvement team then held a workshop to find out what patient groups felt would be important to include when explaining SMC decisions to patients and the public. The process was also informed by reviewing examples of good practice from other parts of NHSScotland, including patient versions of Scottish Intercollegiate Guidelines Network (SIGN) clinical guidelines. Exemplar documents were then developed and feedback sought from the Public Involvement Network Advisory Group.

A format was developed for the SMC ‘Decision Explained’ summaries consisting of a question and answer format for each medicine decision in a two page document. The summaries were piloted internally over a six month period, during which the development process and layout were finalized. Since September 2018 these summaries have been published on the website alongside the technical advice.

Partnership working between SMC and patient groups has helped to develop a new way of communicating SMC's decisions to patients and the public in a clear way, helping to improve transparency and understanding. Evaluation of the summaries will be undertaken from six months of publication.