Conclusions
To our knowledge, this is the first study to identify the priority research questions that a wide range of relevant DFD stakeholders consider important. The final national top 10 priority research questions from the Australian DFD stakeholders in this study covered a wide range of DFD and health research categories, which may be explained by differences in the priorities of consumers and health professionals. In terms of health research categories, consumers seemed to prioritize prevention-related category questions (ie, detection, screening and diagnosis, and evaluation of new treatment), whereas health professionals prioritized management-related category questions (ie, existing management of diseases, and health services research). This trend was further evident in specific DFD categories where consumers prioritized prevention-related DFD category topics (ie, neuropathy, assessment/diagnosis and exercise questions) and health professional management-related topics (ie, health economics and infection questions).
The overall top-ranked question from the total sample potentially reflects the uncertainty that stakeholders have about the health and economic benefits of multidisciplinary DFD services. Multidisciplinary DFD services have long been shown to significantly improve health outcomes23–25 and implementation of best practice DFD treatments has been shown to be cost-effective in managing DFD.26–28 However, global research has also shown that multidisciplinary DFD services are heterogenous in composition and function,29 30 and implementation of best practice treatments is infrequent in real-world practice.31 32 Thus, perhaps it is no surprise that Australian DFD stakeholders are most interested in testing and identifying the health and economic outcomes of existing services. However, according to our findings, this is more of a priority for health professionals than consumers.
While it was expected that the subgroups of consumers and health professionals may show contrasting priorities, the degree of difference was somewhat surprising. Consumer questions focused on prevention-related topics such as etiology, detection, screening and diagnosis of DFD, with specific research on the detection and treatment of peripheral neuropathy (and neuropathic pain) prioritized. This is similar to findings by Diabetes UK, where the cause, prevention and treatment of peripheral neuropathy were prioritized by stakeholders involved with type 2 diabetes, especially consumers.9 These findings are perhaps understandable, as peripheral neuropathy is a major risk factor for DFD, has significant impacts on quality of life,33 there are few effective treatments for neuropathic pain compared with other diabetes complications,34 and there is a cognitive and emotional impact of being at high risk for DFD.35 Furthermore, consumers prioritized exercise-related questions. The safety, efficacy and effectiveness of exercise in relation to DFD have historically been a controversial topic, with recent data suggesting that prescribed exercise may in fact be safe in this population and may have benefits on preventing and treating peripheral neuropathy in addition to general health benefits.36 37 There is, however, no evidence from large randomized controlled trials that exercise prevents DFD or improves outcomes in people with DFD.18 38 Regardless, these priority exercise-related questions indicate that consumers would like more definitive answers on the benefit and risks of exercise on their DFD outcomes.
In contrast, health professionals prioritized research questions relating more to health services research and management of DFD. The top-ranked question for health professionals focused on improving outcomes for Aboriginal and Torres Strait Islander peoples, particularly those living in remote communities. This high prioritization by health professionals is important as the burden of DFD for Aboriginal and Torres Strait Islander people in Australia is disproportionately high compared with non-Indigenous Australians and potentially recognizes the dearth of DFD research in this important population.39 Research into educational programs to improve preventative self-care practices, including offloading adherence, was also prioritized by health professionals. This may reflect the challenges people with DFD have with self-care and how important it is for health professionals to understand the psychological and behavioral mechanisms of feasible and effective self-care behavior in this population.35 There were also management-related priority questions that aimed to address the uncertainties around resolving infection, which included research into the comparative effectiveness of medical versus surgical treatment of osteomyelitis and length of antibiotic duration.15 This has also been an area of much debate for some time and more definitive data are required to assist health professionals with their clinical decision-making to resolve infection.40 Lower ranked in the health professionals’ top 10 priorities was the use of standardized clinical pathways to improve consistency of care. While clinical pathways have been shown to improve care and reduce DFD-related hospitalizations in certain populations in Australia,41 42 current national guidelines on which they are based are now over 10 years old.43 While new Australian national DFD guidelines have been launched in late 2021,44 more research is required to identify the most effective ways to implement best practice into clinical practice.
Most previous studies investigating priority research questions in other health conditions have also used a similar consensus building technique to this study, but with differing procedures and population focus.9 10 45–49 Yet, unlike our study most previous similar studies have recruited health professionals only,10 46 48 49 with fewer including consumers with a lived experience of the condition concerned.9 45 47 An important previous study from the James Lind Alliance and Diabetes UK using a priority setting partnership approach with strong consumer input identified the top 10 research priority questions for people with type 2 diabetes and also found differences between health professionals and consumers.9 In this Diabetes UK study, the only top diabetes research question that was related to DFD focused on the prevention and treatment of peripheral neuropathy and was given much higher priority by consumers living with diabetes than by health professionals.9 Prevention has also been a focus of research priority question development for general foot health, with prevention of ulceration and other diabetes-related foot problems highlighted in two of the top 10 research questions identified.45 It is clear from our collective findings that it is important to include consumers in DFD research priority setting, as consumer research priorities cannot be simply assumed by researchers and are likely to emphasize the importance of prevention, an underfunded and under-researched area of DFD.18
The strengths of this study included the wide range of stakeholders who participated, with a particularly strong consumer and health professional voice. The Delphi design used also aligned with previous frameworks9 10 and was an efficient and transparent process to determine the priorities from such a diverse sample of participants. There was a drop in participation retention rate in Round 2; however, overall participation rates were generally consistent with previous studies from other disciplines and conditions46–49 and the characteristics of participants in each round were very similar. Participation rates may though have been affected by the large number of questions that participants were asked to select from in Round 2, the impact of the coronavirus pandemic, and rounds occurring over the Australian traditional holiday period of December/January. Finally, there was very limited participation from Aboriginal and Torres Strait Islander people and thus the priority research questions identified in this study cannot be considered reflective of the importance to Aboriginal and Torres Strait Islander peoples. It is strongly recommended that future similar studies investigate the priority research questions of Aboriginal and Torres Strait Islander peoples using a more personal approach such as culturally appropriate, qualitative, focus group study designs.
The findings from this study should guide future national research agendas that pursue answers to these important priority research questions and in turn contribute to the reduction of the comparatively large disease burden caused by DFD on patients and nations. In the short term though, these findings should help facilitate diabetes-focused research granting bodies to establish criteria to target researchers and research funding towards these national priority research questions as has happened for diabetes research.9 In the longer term, these findings should assist diabetes peak bodies in lobbying government for targeted research funding which can help to bridge the current funding gap between the high DFD burden and low DFD research funding to address this burden. Lastly, in addition to future research investigating the perspectives of Aboriginal and Torres Strait Islander peoples, it is recommended that future studies from other nations investigate to determine if the priority research question findings of this Australian study are generalizable globally to other nations.
In conclusion, the findings from this study have identified national stakeholder-agreed priority research questions for DFD for the first time. The research questions identified potentially reflect the diversity in priorities across health professionals and consumers. Importantly, though, they also emphasize the need to prioritize research into typically under-researched areas of DFD, such as the prevention, diagnosis and treatment of peripheral neuropathy, and improving Aboriginal and Torres Strait Islander people DFD outcomes. Furthermore, they confirm the more established research need for more DFD research into effectiveness of health service delivery models and therapeutic interventions for diabetes-related foot infection.