Benjamin Schnack Brandt Rasmussen

A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers

OBJECTIVE The role of telemedical monitoring in diabetic foot ulcer care is still uncertain. Our aim was to compare telemedical and standard outpatient monitoring in the care of patients with diabetic foot ulcers in a randomized controlled trial. RESEARCH DESIGN AND METHODS Of the 736 screened individuals with diabetic foot ulcers, 401 met the eligibility criteria and were randomized between October 2010 and November 2014. The per-protocol telemedical monitoring consisted of two consultations in the patient’s own home and one consultation at the outpatient clinic. Standard practice consisted of three outpatient clinic visits. The three-visit cycle was repeated until study end point. The study end points were defined as complete ulcer healing, amputation, or death. RESULTS One hundred ninety-three individuals were randomized to telemedical monitoring and 181 to standard care. Demographics were similar in both groups. A cause-specific Cox proportional hazards model showed no difference in individuals monitored through telemedicine regarding wound healing (hazard ratio 1.11 [95% CI 0.87, 1.42], P = 0.42) or amputation (0.87 [0.54, 1.42], P = 0.59). We found a higher mortality incidence in the telemedical monitoring group compared with the standard outpatient monitoring group (8.68 [6.93, 10.88], P = 0.0001). CONCLUSIONS The findings of no significant difference regarding amputation and healing between telemedical and standard outpatient monitoring seem promising; however, for telemedical monitoring, a higher mortality throws into question the role of telemedicine in monitoring diabetic foot ulcers. Further studies are needed to investigate effects of telemedicine on mortality and other clinical outcomes and to identify patient subgroups that may have a poorer outcome through telemedical monitoring.

A qualitative study of the key factors in implementing telemedical monitoring of diabetic foot ulcer patients

INTRODUCTION The implementation of telemedicine often introduces major organizational changes in the affected healthcare sector. The objective of this study was to examine the organizational changes through the perception of the healthcare professionals regarding the implementation of a telemedical intervention. We posed the following research question: What are the key organizational factors in the implementation of telemedicine in wound care? METHODS In connection with a randomized controlled trial of telemedical intervention for patients with diabetic foot ulcers in the region of Southern Denmark, we conducted an organizational analysis. The trial was designed as a multidisciplinary assessment of outcomes using the Model of ASsessment of Telemedicine (MAST). We conducted eight semi-structured interviews including individual interviews with leaders, and an IT specialist as well as focus group interviews with the clinical staff. A qualitative data analysis of the interviews was performed in order to analyze the healthcare professionals and leaders perception of the organizational changes caused by the implementation of the intervention. RESULTS The telemedical setup enhanced confidence among collaborators and improved the wound care skills of the visiting nurses from the municipality. The effect was related to the direct communication between visiting nurses and specialist doctors. Focus on the training of the visiting nurses was highlighted as a key factor in the success to securing implementation. Concerns regarding lack of multidisciplinary wound care teams, patient responsibility and lack of patient interaction with the physician were raised. Furthermore, the need for clinical guidelines in future implementation was underlined. CONCLUSIONS Several influential factors were demonstrated in the analysis including visiting nurses wound care training, focus on management, economy, periods with absence from work and clinical care. However, the technology used here could provide an additional option to offer patients after an individual assessment of their health condition.

Substantial reduction in the number of amputations among patients with diabetes: a cohort study over 16 years

Aims/hypothesisThe aim of this study was to describe the trends in rates of amputation among individuals with and without diabetes.MethodsWe studied amputation rates in the County of Funen (approximately 0.5 million residents) during the period 1996–2011. Amputations were identified from the hospital administrative system, diabetes status by linkage with the Danish National Diabetes Register, and mortality and population data by extraction from Statistics Denmark. Amputation rates were analysed using proportional hazard models. We analysed the incidence of the first amputation at each level as well as the incidence of further amputations, subdivided by level of amputation.ResultsDuring the period 1996–2011, a total of 2,832 amputations were performed, of which 1,285 were among patients with diabetes and 1,547 among individuals without diabetes. Relative to persons without diabetes, patients with diabetes had an HR for below-ankle amputations (BAAs) of 14.7 for men and 7.5 for women, and for from-ankle-to-knee amputations (BKAs) of 7.6 and 8.4 for men and women, respectively. For above-knee amputations (AKAs) the numbers were 4.0 for men and 3.7 for women. We found an annual reduction in BAA rates among patients with diabetes of 9.8%, and the annual reduction in BKA for patients with diabetes was 15.1%.Conclusions/interpretationThe amputation rate in patients with diabetes is still several-fold higher than in persons without diabetes, but the improvements in diabetes care in recent years have resulted in a steady decline in amputation rates among patients with diabetes from this Danish cohort.

Validation of a new imaging device for telemedical ulcer monitoring

To clarify whether a new portable imaging device (PID) providing 3D images for telemedical use constitutes a more correct expression of the clinical situation compared to standard telemedical equipment in this case iPhone 4s.

Cost-effectiveness of telemonitoring of diabetic foot ulcer patients.

This study compared the cost-effectiveness of telemonitoring with standard monitoring for patients with diabetic foot ulcers. The economic evaluation was nested within a pragmatic randomised controlled trial. A total of 374 patients were randomised to either telemonitoring or standard monitoring. Telemonitoring consisted of two tele-consultations in the patient’s own home and one consultation at the outpatient clinic; standard monitoring consisted of three outpatient clinic consultations. Total healthcare costs were estimated over a 6-month period at individual patient level, from a healthcare sector perspective. The bootstrap method was used to calculate the incremental cost-effectiveness ratio, and one-way sensitivity analyses were performed. Telemonitoring costs were found to be €2039 less per patient compared to standard monitoring; however, this difference was not statistically significant. Amputation rate was similar in the two groups. In conclusion, a telemonitoring service in this form had similar costs and effects as standard monitoring.

eHealth in Wound Care: from conception to implementation

Executive summary Purpose This document aims to provide wound care clinicians with a rapid and structured overview of the key issues related to use of eHealth applications (telemedicine and telehealth) within wound care. This includes: An overview of terminology and available literature Guidance on the methodology for evaluation of eHealth solutions An introduction to and discussion of the potential benefits of eHealth technologies in wound care, and the possible barriers to their implementation Recommendations for ensuring a good implementation process and supporting involvement of wound care professionals in safeguarding that eHealth solutions meet the needs of the patients. Methodology The document sections lean on the structure and focus areas of the Model for ASsessment of Telemedicine (MAST) which defines crucial items to evaluate an eHealth application. The content of the document is developed on the basis of a literature review, identifying available documentation for use of eHealth solutions in wound care. Furthermore, it draws on various key documents recently published on the general development, evaluation and implementation of eHealth solutions. These include valuable up-to-date information relevant for any group of clinicians wishing to follow and influence the way eHealth solutions are integrated into clinical practice. Findings and conclusions The literature review revealed that the amount and level of evidence for use of eHealth applications in wound care is still limited. Some MAST domains are not examined in any of the available studies. Thus, more research is required to identify the potential benefits and harms to patients, and the possible challenges related to implementation of eHealth solutions in wound care. Potential barriers and facilitators for the implementation of eHealth applications into wound care practice are identified in the document, and these may all either enhance or impede the process. However, the available research does demonstrate patient satisfaction, improved access to health services for all client cohorts, and increased job satisfaction for clinicians. The document recommends that wound management clinicians, considering the use of eHealth applications in their clinical practice, consult widely and conduct regular evaluation of the outcomes to ensure efficient implementation of these services. To support this approach, steps to ensure a good implementation process within a given organisation have been proposed. These are synthesised into a three circle model.

Chapter 3: The model for assessment of telemedicine (MAST) – evaluation of telemedical solutions

In 2009, a group of researchers were asked to develop a specific model for assessing telemedicine (MethoTelemed) and this led to the development of a multidisciplinary, systematic, unbiased and robust system named MAST.16 This document describes the three steps in evaluating procedures, focusing on mature eHealth technologies to be introduced in the health-care services, targeting individuals with a variety of diseases. These steps include:

Chapter 5: Barriers and facilitators for eHealth

When practitioners and service providers look to introduce eHealth technologies they are often confronted by a confusing array of advice; the complexities of the devices, the infrastructure requirements and the best approach to user education. A rapid expansion of technological options and the need to ‘future proof’ any investment can result in health-care providers taking a conservative approach. This section explores the barriers and facilitators to the use of eHealth in an effort to help provide a framework for judicious decisions for effective implementation. The discussion draws from MAST and focuses on the patients, health practitioners, and services.

Chapter 7: Conclusion

Conclusion This final chapter emphasizes the major results that we have obtained in this thesis. We also provide suggestions for future enhancements of the work that we have done here. In this thesis, we have presented an algorithm to estimate all the unknown parameters in an EPS model. This algorithm consists of a sub-optimal initial estimate which is then refined by an iterative ML algorithm. Both the initial estimate and the iterative algorithm have been shown to be computationally efficient. Specifically, the estimate obtained from each of these algorithms can be determined with a number of multiplications that is on the order of the number of observations. The statistical analysis for these algorithms was examined by considering a perturbation analysis. This perturbation analysis yielded several important results and observations. First, we observed that for each of the algorithms we examined, the MSE of the estimate depends only upon the amplitude of the signal and not the phase. Thus, the best choice (in the sense of minimizing the MSE of the estimate) of the delay parameters will be a function of only the amplitude of the signal. When the signal has a constant amplitude, we show that the delay parameters can be chosen off-line to minimize the MSE of the estimate. If the amplitude of the signal is not known, then one can use an algorithm that we have presented to determine the delay parameters adaptively. The perturbation analysis revealed several properties that the sub-optimal estimation algorithm and the ML estimates have in common. One such property that is valid for each of these algorithms is that the estimates for the real parts of the signal parameters are uncorrelated with the estimates for the imaginary parts of the signal parameters. Another such property is that the first-order approximation of the MSE of the real part of the estimate is the same as the imaginary part. Note that although the first-order approximation

Chapter 6: Road map for implementation in clinical practice

Circle 1: Outer circle Step 1: System model As the first step, the type of system (service aim, technology, organisational implications) should be considered and decided on. This should be done with the reasons in mind for integrating this eHealth solution into the current clinical practice. For example which problems/challenges is it intended to solve and why is this type of system believed to solve the problem/challenges? You should also consider all relevant alternatives, to be sure that you are working with the best suited solution. This is an integrated part of the preceding considerations of the MAST evaluation. eHealth solution Safety: data, patients, staff