Among persons living with diabetes, it is estimated that 5% have a foot ulcer [1-5]. This means that 23 million persons (5% of 537 million people with diabetes) at the global level [6] and 25,000 persons in Sweden have a diabetic foot ulcer (DFU) [7]. A large increase in people diagnosed with diabetes (increase to 783 million people) is expected by 2045 [6].

Groups with a low socioeconomic status have an increased risk of DFU, and men are more frequently affected [8-10]. A delay in detecting persons at risk of developing a DFU and a delay in access to treatment increase the risk of further complications, such as severe infections, leading to amputations [11].

The consequences of delayed treatment and a lack of foot screening are important for the individual and society. The quality of life of the individual is reduced in the presence of a DFU, and the costs are considerable [12-16]. The structure of health care differs between countries, as does the pathway toward prevention, and as a result, the treatment costs for DFUs vary among high-, middle-, and low-income countries [17]. Nevertheless, the impact on individuals in terms of their psychological well-being and their private economy is significant. The impact varies depending on the organization of health care in each country. In Sweden, health care is financed by taxes, and the 21 independent regions are responsible for delivering equal care of a high standard [18].

With effective prevention and structured processes among primary care, specialist care, and municipal care, DFUs can be successfully prevented [19-23]. Of the 500,000 persons with diabetes in Sweden, the majority are treated in primary care [7]. Promising examples show that, by using a structured standardized routine for foot assessment and risk stratification, greater quality of care is achieved [24,25]. In contrast, the lack of a structured foot assessment might lead to subjective risk stratification and inappropriate or nonactive consequences [26,27].

National and international guidelines recommend that an annual foot examination should be offered to all patients with diabetes [28-30]. However, figures from the Swedish Diabetes Register show that the feet of 25% of people with diabetes were not examined in 2022 [31]. Traditionally, in Sweden, patients’ feet are examined at the same time as the annual diabetes examination in primary health care or at a clinic of medicine in specialist care. The examiner could be a physician, nurse, or podiatrist. After the examination is completed, the health care professional (HCP) should register in the Swedish Diabetes Register (1) that the person has undergone examination of the feet and (2) the risk grade of the person from 1 to 4 (1 [no risk of developing a DFU] to 4 [ongoing DFU]), with subsequent actions based on the risk category (Figure 1) [28]. The risk grade is based on findings of peripheral neuropathy, for example, identified with a monofilament test or the Ipswich Touch Test [32]; peripheral angiopathy; foot deformities; skin pathologies; foot ulcers; and previous foot ulcers/amputations [29].

Patient representatives and HCPs found it necessary to improve the routine of the annual foot examinations for persons living with diabetes in Västra Götaland Region (VGR), with the aim of enabling all patients with diabetes to have their feet examined in a structured uniform manner. As a result, a novel structured routine in paper format, a paper form, was developed and tested by persons with special competence in the area (Multimedia Appendix 1). This paper form was suggested as an initial tool to help HCPs perform annual foot examinations, as recommended in national guidelines [28]. Adhering to participatory design (PD) principles, the research team was aware that the focus of PD is not only the improvement of the information system but also the empowerment of workers, so they can co-determine the development of the information system and their workplace [33]. For this reason, before the form is designed for creating an existing or future clinical decision support system (CDSS), it needs to be validated by real users, that is, the HCPs performing the actual foot examinations in primary care.

In a previous project in the same region, VGR, a pilot test of a digital prototype was performed by a certified orthotist and prosthetists. It was shown that, by using a structured eHealth solution, the foot assessment and the subsequent automatically generated risk category produced a reliable uniform assessment, thereby facilitating documentation [26].

Eliciting future users’ real experiences is crucial in user-centered design (ISO 9241-210:2019) [34]. User experiences are differentiated from opinions, which could be held by designers, managers, or other secondary stakeholders of a system, as well as future users of that system. User experience is defined as “users’ perceptions and responses, including the users’ emotions, beliefs, preferences, perceptions, comfort, behaviors, and accomplishments, that occur before, during, and after use,” and it is related to “the context of use” [34]. Here, the context of use often means on the floor, close to a sitting patient, where the HCP examines the feet using various techniques and tools (Figure 2). It is therefore important to validate not only the information in the new tool but also the fact that novel tools can actually succeed in the clinical work situation of an HCP. To prepare for a digitally supported routine of a structured foot examination in an annual foot assessment, the structured routine was validated by real users, that is, HCPs in daily practice, performing daily work tasks on the floor. This study aimed to describe HCPs’ experiences of a novel structured foot examination form on paper (Multimedia Appendix 1) when performing annual foot assessments in patients with diabetes.

The study is part of a larger regional project designed to optimize the care of persons with diabetes and foot complications. In this study, a qualitative descriptive approach was used to sum up the empirical data inductively in order to produce a common understanding that relates to general conditions within this context.

The study took place in 5 primary health care centers and 3 hospital care centers located in southwestern Sweden. To optimize a digital routine, the form in a paper routine (referred to as “form”) was used and tested by professional caregivers (Multimedia Appendix 1). The participants in the study were HCPs who usually examine the feet of individuals with diabetes, and they were strategically invited to test a form for annual foot examination. A total of 16 HCPs were asked to participate. Among these HCPs, 12 registered an interest in participating in the project and 8 were finally included. Three declined when asked to participate in the interview study and 1 person did not respond. Among the 8 participants, 3 were district nurses/specialist diabetes nurses, 3 were podiatrists, and 1 was a physician. The dropout resulted in a lack of nurses working in municipal care.

Semistructured interviews were held in March 2021 with 2 focus groups and 2 individual interviews including 8 respondents from different professions within diabetes care (Table 1).

The respondents were interviewed about their experience of examining the feet of patients with diabetes according to the new form (Multimedia Appendix 1). The respondents had each used the form on at least five patient visits. The interviews took place digitally where the interviewers and respondents could see and hear each other during the interviews, apart from one individual interview where only sound was recorded. The interviews lasted between 30 and 90 minutes, and were recorded digitally, listened to several times, and transcribed verbatim by 2 authors (UN and MV). Open-ended questions regarding the experiences of working with the form in clinical practice were addressed and a semistructured interview guide was used (see examples in Multimedia Appendix 2). The opening question was “How comfortable do you feel about using the paper form in routine work?” Examples of other questions were “What were your expectations of the effectiveness of the form?” “What were your expectations of the degree of effort?” “How well does the form correspond to the expectations/help you to achieve the goal of the foot examination?” and “What is important to you?” (for further questions, see Multimedia Appendix 2). The interview guide ensured that a certain area of questioning was covered [35].

The qualitative research tradition is based on an effort to develop an understanding of the human lived experience. Qualitative content analysis, as described by Graneheim and Lundman [26], was considered appropriate in order inductively to focus on and describe experiences and variations on an individual level and to identify differences and similarities on a manifest and latent level. The analysis was conducted in several steps. First, all the data were read several times to ensure immersion in the data. All interview text was regarded as a unit of analysis. The text was then divided into “meaning units” that corresponded to the aim of the study. Each meaning unit was condensed and labeled with a code. Codes are described as concrete and as close to the text as possible [36]. During this process, the authors (SA, UN, and MV) continuously returned to the original text to ensure that the core meaning of the meaning units was maintained. Similar codes were later grouped into subcategories, and sorted and abstracted into higher categories (Table 2).

Finally, the latent interpretative analysis was described as the main theme with a higher level of interpretation and abstraction.

A continuous verification of the interpretation was an ongoing process during the search for coherence among the different parts of the analysis. To ensure trustworthiness, there was an awareness of and an openness toward misunderstandings resulting from the interviewer’s own preunderstanding. To avoid misunderstandings, the data were first analyzed individually and later compared by 3 researchers.

The study was approved by the Swedish Ethical Review Authority (diary number: 2020-02715 and 2020-05131) and was conducted according to the ethical principles described in the Helsinki Declaration [37]. All participants were informed, both verbally and in writing, about the study before obtaining their written informed consent. The participants were ensured confidentiality and were free to withdraw at any time. The transcripts were anonymized and given a letter (A-H), which was subsequently used in the analysis. The possible harm caused by the study was evaluated against the benefits. The participants were informed that any concerns could be clarified by contacting the authors. No such concerns were raised.

The results at the highest level showed that the participants felt that the theoretical support provided by the form was needed (Multimedia Appendix 1), but it also had to be verified by the HCP’s judgement, experience, and knowledge, which was reflected in the practical implementation. The main theme was “structure and documentation as a support for professional judgement” (Table 3). Three themes were identified: (1) structured support, (2) professional evaluation is needed, and (3) documentation that simplifies and makes visible, referring to both patients and their feet. Multimedia Appendix 3 presents some examples of expressions that are cited in this study in Swedish and English.

The theme of structured support included the respondents’ experience of the structured foot examination protocol and that it offered structure, clarity, and support in performing foot examinations.

The theme includes the need for professional judgement to evaluate certain aspects of the foot examination. Judgement was needed whenever the form was used, from the interpretation of the risk categories and different concepts to the actual conduct of the examination.

The theme includes the structured form being perceived as making visible and clarifying the importance of foot examinations for both the patient and HCP, and the documentation needing to be facilitated and made visible, with the hope of simplification in the future digital format.

According to the respondents, there were expected results, as well as some unexpected findings. First, the most important finding was that adherence to clinical guidelines was facilitated using the form. Similar experiences were expressed by both experienced professionals and those with less experience. Second, when evaluating the risk of developing DFUs, professional judgement was emphasized by the respondents. Just filling in a paper form does not improve the quality of care, as stated by the respondents. Judgement was needed throughout the use of the form, from the interpretation of the risk categories and the different contexts to the actual conduct of the examination, as well as when dealing with follow-up actions. However, the form provided the necessary structure and support in the decision-making process.

By using the form, the respondents also found that they had a new educational tool in their hands. The form could be used as an incentive, for example, to clarify the different parts of the foot examination for the patient and why these parts were checked, and as a result, it became an educational tool. One unexpected finding was that the respondents stated that it felt natural to use the form to initiate conversations about self-care, medical foot care, any need for insoles, and advice on choosing shoes. By creating processes that lead to the patient becoming involved, the potential for autonomy and self-determination also increases for the patient [38]. The form thus strengthens the patient’s participation and partnership, in line with person-centered care [39] and the theories of shared decision-making [40] and self-determination [41].

As part of the completed foot examination, the respondents also found that time to form a professional judgement was required to evaluate the results based on each person’s needs and to connect the results to the next activity in the care plan.

After using and validating the form according to current work practices, some expected results were obtained, for example, the structure helped to perform the examination and the form also required professional judgement to be taken into account when formulating the individual results and needs into recommendations and further steps in the care plan. The respondents were surprised that the form was also suitable as an educational support tool when discussing self-care with the patient. This is often the case, and positive side effects like this emerge when users are allowed to handle novel tools or prototypes in their real work setting or in a user situation [42]. It is crucial for users to be involved at an early stage in the design process [34]. From the point of view of the PD method used, we could also see that these unexpected findings could be the subject of future studies and included in the design of the next stage of digital CDSS development.

Involving a user-centered design process, this study followed the basic steps where an early design should be tested in a realistic setting, even before software is developed. Previous research on the process of user needs and context requirement gathering reminds us that “actual requirements pre-exist our effort to capture them” [43]. This means that, as developers, designers, researchers, and other work process experts, we must be careful not to create requirements that fulfill only our own technical or organizational desires. This concept is particularly important in domains where users are less familiar with digital tools [44]. To resolve this issue, the validation process used in this study aimed to emphasize real needs, as expressed by real users. An understanding close to “best practice” will enable us to design and develop a digital tool and simultaneously assist in structuring and enhancing the work process of HCPs managing patients with diabetes. Moreover, the results here will generate a detailed context of use analysis, based on the experiences of real future users, which in turn will result in a shorter and less expensive development phase. For future iterations, the respondents who were active in this study have already volunteered for further work, knowing that their points of view will be included. Another strength here is that the validation was carried out by HCPs with both long-term and short-term experiences of foot examinations, who had different professions and worked at different care units (both primary care and regional care).

A qualitative method always involves subjectivity, as the researcher is part of the research. By being aware of one’s own preunderstanding, this issue can be managed throughout the process. During the analysis, a continuous dialog took place and a broader understanding was created to achieve a reliable result [45].

The dropout of 4 participants meant that no individual from municipal care participated. Thus, the transferability of the study results might not apply to all forms of care. One weakness of the study was that the use of the form was not very high, but the data that emerged during the interviews were perceived to be rich and to have a high degree of validity.

In line with previous studies, this study provided promising examples that the use of structured standardized routines for foot assessment and risk stratification can lead to higher quality of care [24,25]. The informants in this study stated that a structured routine would enhance care. Higher care quality for patients with diabetes and reduced health care costs are expected [13,46] after the early detection of risk factors, followed by rapid prevention, including a dialog on self-care, a referral to podiatry, and a referral for therapeutic footwear. Overall, the prevention of DFUs will preserve the quality of life of patients [24,25].

The foot examination form works well as a support tool during a preventive foot examination. It offers a basis for decision-making and could contribute to a uniform safer foot examination with more care equality, which is consistent with current national guidelines. The form may need to be supplemented with functionality to increase usability in connection with foot examinations, that is, printing and handing over personally adapted self-care advice based on the results of the foot examination. All the respondents appreciated participation in the validation of a digital tool for enhancing their daily routine.