We designed the study using a mixed method application of structured prioritisation principles that have been applied in numerous research policy settings [7, 8, 12,13,14,15]. This step-by-step process is based on multi-criteria decision analysis [16], and emphasises a participatory and consultative approach. The project comprised three major stages:

1.

Determining the prioritisation process, goals, and scope;

2.

A national survey of experts and community representatives, to create a ‘long list’ of potential unmet needs; and

3.

Prioritisation roundtables where experts and community representatives applied explicit prioritisation criteria to the deduplicated ‘long lists’ to determine the highest priority unmet needs for funding.

The research activities in this project received ethical approval by Monash University’s Human Research Ethics Committee (Project Number: 26586).

Stage 1: Determining the prioritisation process, goals, and scope

The research team (EG, EK, LC, AS, PB), in collaboration with MTPConnect (represented by LK), determined the goals and scope of the prioritisation process. This was then endorsed by the independent TTRA Expert Advisory Board. This was especially important because the priority unmet needs would form the basis of calls for research funding, and research activities supported by the funding needed to achieve the objectives of the TTRA program. Table 1 presents the resulting prioritisation parameters.

Table 1 Prioritisation scoping questions and decisionsTable 2 Elicitation of unmet needs for cardiovascular disease, diabetes, and their interactions in the national survey (experts vs community representatives)Stage 2: National survey

We developed a survey of Australian adults with expertise or knowledge of the lived experience of CVD and/or diabetes to generate a ‘long list' of unmet needs. We chose this method to maximise national reach and ensure that each respondent could respond anonymously. The target audience of the survey were (1) adults with expertise in CVD and/or diabetes, including people who specialised in treatment, research, or management; and (2) adults who lived with, or cared for, people with, CVD and/or diabetes (henceforth referred to as community representatives).

We co-designed the survey with methodology and recruitment experts, MTPConnect, and the TTRA Expert Advisory Board to ensure it would be accessible to the target audience and align with the project goals and scope (see Stage 1). The full survey is presented in Supplementary Materials (Supplementary File 1: Survey). We collected data on whether participants had expertise in CVD and/or diabetes (e.g., researchers, clinicians) or had knowledge of the lived experience of these diseases, as well as demographic information. The survey included questions intended to elicit unmet needs for CVD or diabetes, or both, from participants. We used different wording for experts and for community representatives to maximise accessibility. Table 2 summarises how we elicited unmet needs for each audience group and focus area. See Supplemental Materials (Supplementary Files 2–4) for the relevant surveys.

Survey participants and recruitment

MTPConnect and Research Australia, the national peak body for Australian health and medical research, distributed the survey to approximately 500 individuals and organisations. The distribution list included Australian health and medical researchers, clinicians, health professionals, policymakers in state and national health departments, and national and international private organisations with interests in CVD and/or diabetes. The research team asked not-for-profit organisations working in CVD and/or diabetes to distribute the survey through their community networks. We encouraged explicit efforts to reach community networks, given that their involvement improves research outcomes by ensuring relevance to community needs [7, 17]. The team sent a follow-up reminder a week after the initial survey invitation and held the survey open for two weeks.

Analysis of unmet needs

We conducted inductive thematic analysis to organise the unmet needs identified in the survey. The inductively derived coding framework had two levels: Level 1 codes for the body system (for example, Cardiac), and Level 2 codes for the specific body part or issue within that system (Cardiomyopathy or heart failure). Two researchers independently coded 100 unmet needs to develop an initial coding framework. The research team discussed discrepancies, then refined the coding framework. One researcher coded the remaining unmet needs for each focus area (CVD, diabetes, or interactions in the pathogenesis of Type 1 diabetes, Type 2 diabetes, and cardiovascular disease). The research team met regularly throughout the coding process to maximise consistency of the approach and to further refine the coding framework.

Finalising the lists of identified priorities

Once all unmet needs had been coded, we cleaned the dataset and removed duplicates. We removed incomplete survey responses and responses that could not be interpreted as unmet needs (such as generic statements like ‘use technology to improve diabetes management’). Removal of duplicates involved combining unmet needs that were very similar, but which used different wording, into a single coded unmet need (for example, the responses ‘Islet transplantation to address diabetic retinopathy resulting in less vision loss’ and ‘Early treatments for diabetic retinopathy to prevent progression to vision loss’ were combined into the unmet need ‘Eye, Retinopathy’). This meant we gave equal weight to all unmet needs generated in subsequent prioritisation, because the final deduplicated ‘long list’ did not convey how many survey responses had mapped to each coded unmet need.

Stage 3: Prioritisation roundtables

We conducted three roundtables to apply pre-specified and explicit prioritisation criteria to the deduplicated ‘long lists’—to determine the highest priority unmet needs. Each roundtable addressed one of the three focal areas: (1) Complications associated with diabetes; (2) Complications associated with CVD; or (3) Interactions in the pathogenesis of Type 1 diabetes, Type 2 diabetes, and CVD.

Prioritisation criteria

The TTRA Expert Advisory Board and MTPConnect developed the prioritisation criteria (presented in Table 3), drawing upon criteria used in previous projects [12].

Table 3 Prioritisation criteria for unmet needs in cardiovascular disease and diabetes

The TTRA Expert Advisory Board decided that clinical impact and quality of life should be weighted as double the value of other criteria, because a key objective of the TTRA program funding is to improve clinical practice to reduce the burden of CVD and diabetes.

Roundtable recruitment and procedure

Following consultation with the TTRA Expert Advisory Board, we approached a national and diverse list of organisations to nominate experienced individuals to participate in the roundtables. We took care to include organisations which would bring diverse yet complementary perspectives including clinical, research, health professional, health administration, Aboriginal and Torres Strait Islander health, community, industry, and investor. Following their nomination, we sent the individual participants an explanatory statement and asked them to provide consent prior to attending the roundtable.

We conducted the roundtables online, each for 2.5 hours in length. See Supplementary Files 2, 3, and 4 for roundtable agendas, briefing information for participants, and the deduplicated 'long list' of unmet needs. We followed the Chatham House Rule [18] meaning that we did not disclose the identity of participants following the roundtable nor attribute statements publicly. We provided participants with an overview of the project and time to read the deduplicated 'long list' of unmet needs. Participants then considered each prioritisation criterion in turn, and anonymously voted for their top three unmet needs according to that criterion, using an interactive polling platform. We calculated the votes for each unmet need across all criteria (with the clinical impact and quality of life criteria weighted at double). Participants discussed the top five prioritised unmet needs in facilitated groups. Guiding questions encouraged participants to discuss their initial reactions to the results, their knowledge of the current state of the science, and how the impact of the TTRA funding could be maximised.

The TTRA Expert Advisory Board used the research report summarising the voting results and key themes to finalise the top three priorities in each focus area that formed the basis for research funding calls.