The most important finding when studying the development of a structured digital routine for foot assessment (CDSS) for patients with diabetes is the high level of satisfaction with the services at the DPO. Similar results were found, measured by a modified version of the National Patient Survey and Orthotic and Prosthetic Users’ Survey, for the intervention group and the control group. The high level of satisfaction, regardless of the method, can be explained by biases such as the involved CPOs being highly experienced, the Hawthorne effect, meaning that study participants might change behaviour or perceptions to be more positive as a consequence of the attention they receive, regardless of the intervention (42, 43); the DPO was friendly and clean and, finally, the level of care given by the DPO was already at high. In clinical practice where a high level of care already exists, potential improvements are difficult to measure in an RCT. Moreover, the method used could have limitations when it came to measuring satisfaction with the service at the DPO. Before discussing these explanations, the advantage of a digital routine is discussed.
In this study, like previous studies (17, 44), several advantages are obtained when using a CDSS, the D-Foot. They are: the foot assessment and the risk stratification follow national clinical guidelines (12, 45); the risk stratification is generated by the system and is therefore objective (15); the registration in the EHR at the DPO was made faster when the results of the digital foot examination were used as a basis for the documentation, < 5 minutes (n = 1 CPO) and 6–10 minutes (4 = CPOs), compared with a traditional examination, 6–10 minutes (n = 4 CPOs) and 11–15 minutes (n = 1 CPO). Moreover, information regarding the use of medicine for high blood pressure, heart diseases and information regarding perceived preventive interventions (podiatry and information on self-care of the feet) is useful prior to a discussion of the care plan. The descriptors registered in the D-Foot, such as profession, use of medicine for high blood pressure/heart disease and interventions to prevent DFUs are of great importance. In the present study, we found that this information was not registered for the control group.
It is noteworthy that patients in the intervention group reported limited access to podiatry or information about self-care of the feet, despite national clinical recommendations for diabetes (12). Moreover, one-third of the patients said that their feet had not been examined during the last 12 months.
The results in Table 3 reveal that, by using the CDSS, 100% of the patients were risk classified, in contrast to the control group where only 2% were risk classified. Moreover, 83% of the patients in the intervention group were classified as risk grade 3. The patients in risk grade 3 had one or more of the risk factors: foot deformities, skin pathologies, previous DFU/amputation and signs of angiopathy/neuropathy and were in great need of prescribed footwear. If foot deformities, such as hallux valgus, limited range of motion in foot joints and gait deviation are not assessed or skin pathologies are neglected, there is a risk that the prescribed footwear will be based on weak reasons and that advice on self-care will be left out (8, 41). Eleven per cent had DFUs and were categorised in risk grade 4. The lack of risk classification in the EHR for the patients in the control group is serious. The negative consequences for the patient if the risk classification is not registered are severe. If an ulcer (risk grade 4) is not noticed and therefore not registered, it is a great concern that the adequate offloading device will not be prescribed, thereby prolonging the healing period (4).
The nationwide use of a CDSS, like the use of the risk tool in Scotland, is necessary to ensure patient security and we therefore recommend the full implementation of the CDSS at the DPOs in Sweden. This would increase the proportion of patients whose feet are examined, who are risk classified and are prescribed the appropriate therapeutic footwear or orthoses. Furthermore, the meta-data from the CDSS create an opportunity for audits and the continuous improvement of foot care (19, 20).
In the current study, no adverse events occurred as a result of using the CDSS. It was not cumbersome (no pain, no complications) for the patient, but nor was the traditional method evaluated in this study.
Refinements of the CDSS
Further developments in the co-design of the CDSS, following the ISO standard, were requested (16): add fields to make registrations of co-morbidities, specify the level of amputation, specify the location of the ulcer, change the order of measurements and add measurements of foot deformities, e.g. the Coleman block test (46).
To be able to promote the patient’s integrity, self-determination and participation in the prescription of assistive devices for patients at risk of developing DFUs, the integration of the EHR between primary care, municipality care and specialist care is needed. At the time of this study ,the DPO used its own EHR, which was not integrated with the EHR in primary care or other units at Sahlgrenska. This means that, if a person moves to another location, the EHR, with information on the patient’s risk stratification and risk factors, does not follow the patient. Integration between the DPO’s EHR, the EHR used in the municipality and the EHR used in primary care and specialist care is therefore needed. One registration is required, meaning that if, for example, blood glucose levels and the use of medicine for high blood pressure are registered in the EHR, as the patients are examined in primary care, this registration should also be available in the EHR at the DPO. Bridging healthcare borders between primary and specialist care, in the care of DFUs, is more complex, as described by Koltveit et al., but it is possible (24, 47). Like Koltveit et al., the authors plan to involve stakeholders (policy makers, healthcare managers, IT departments, patient representatives and clinicians) in the implementation process, as they are the cornerstones of success (48). The goal is to create integrated care across different levels of healthcare providers (48).
Our results show that important information is missing in the EHR for the control group. By using a CDSS, the CPOs will enhance their skills and documentation will be improved [23]. Moreover, like the findings reported by Koltveit et al., increased skills and knowledge among the HCPs are expected.
A prerequisite for national improvements in the care of DFUs is the integration of the CDSS with quality registers such as RiksSår, the Swedish national quality register for ulcer treatment (49, 50), and the National Diabetes Register (40). At the time of this study, these registers did not register foot parameters, the number and proportion of patients in each of the risk categories and the underlying risk factors.
In further research, the usability of the D-Foot should be evaluated by all users: patients, CPOs, healthcare managers, IT experts and other healthcare givers (27). Moreover, a long-term effect of using a CDSS, with a reduction in the number of DFUs in primary care, is expected and should be of interest in future studies. In order to check that preventive interventions reach PDs, the number and proportion of patients who are referred to podiatry should be registered and followed up (12).
Limitations and strength
In current RCTs, a number of dropouts were due to patients not turning up at the department, technical errors or the fact that the surveys were not completed. Instead of groups consisting of 58 participants, the final number was 47 for the intervention group and 53 for the control group. A recommendation for future studies is to increase the number of participants by 10–15% compared with the number obtained from the power analysis to compensate for dropouts. In the current study, the study period followed the recommendation of one month from the Swedish Association of Local Authorities and Regions when collecting answers with the national patient survey. A prolonged study period would have increased the number of participants.
Some considerations in the study are related to the study participants. Selection bias, meaning that participants with more motivation are anticipated, might lead to a positive score in the answers in the survey.
To strengthen future studies, we recommend that the registrations regarding the time it took to make the foot examination and to make the registration in the EHR are observed and registered by an independent observer following the CPO during the study. In the current study, each CPO made an approximation of the time taken for these tasks, for the intervention group and control group respectively, at study end. The registration should preferably be made after each individual appointment. Another improvement is that the DPO should answer the question regarding the interaction with the patient after each individual patient that the CPO examined, not at study end as a summary registration.
In the NPS and OPUS, some questions were related to the environment and the waiting time at the DPO. These questions do not appear to be relevant when measuring differences between groups regarding their experiences of the services at the DPO and how PDs experienced the foot examinations. The irrelevant questions were: question 26 in NPS “Did you feel that it was clean at the clinic? and question 3 in OPUS “I waited a reasonable amount of time to be seen” (38). Moreover, the patients that participated in the current study did not wait a long time in the waiting room because the principal investigator rapidly took care of the patient. Moreover, the following questions, 13, 14, 17, 18 and 21, were not relevant in a DPO setting, despite being relevant to healthcare in general. Many participants answered these questions with “not applicable!”. Even if the NPS, the nationwide survey used to measure patient-perceived quality and experience of healthcare, was recommended (31), we suggest that OPUS with the Client Satisfaction with Services module (CSS) should be used in further studies as a tool to assess how satisfied patients are with the devices and the services at the DPO (37, 38), in addition to qualitative methods for studying usability (27).
To strengthen similar study results, we recommend that surveys are filled in at the clinic on the final visit. In this study, some patients left the DPO without filling in the NPS or OPUS. To collect their answers on the surveys, an envelope including a postage-paid reply envelope was sent to them with an information letter asking them to fill in the survey. However, three patients did not return their answers.
Regarding statistics, the results of the 27 questions in the NPS in Table 4 do not take account of the fact that multiple comparisons are made. As a result, the original alpha values are reported. Detecting whether a new intervention is superior to the traditional way of working in existing high-level care is difficult with traditional RCTs (51). In future studies, we recommend that equivalence studies should be considered as an alternative approach to determine whether the new intervention is having similar effects to traditional practice (52).