Exploring the Role of Complexity in Health Care Technology Bottom-Up Innovations: Multiple-Case Study Using the Nonadoption, Abandonment, Scale-Up, Spread, and Sustainability Complexity Assessment Tool.

BACKGROUND: New digital technology presents new challenges to health care on multiple levels. There are calls for further research that considers the complex factors related to digital innovations in complex health care settings to bridge the gap when moving from linear, logistic research to embracing and testing the concept of complexity. The nonadoption, abandonment, scale-up, spread, and sustainability (NASSS) framework was developed to help study complexity in digital innovations. OBJECTIVE: This study aims to investigate the role of complexity in the development and deployment of innovations by retrospectively assessing challenges to 4 digital health care innovations initiated from the bottom up. METHODS: A multicase retrospective, deductive, and explorative analysis using the NASSS complexity assessment tool LONG was conducted. In total, 4 bottom-up innovations developed in Region Västra Götaland in Sweden were explored and compared to identify unique and shared complexity-related challenges. RESULTS: The analysis resulted in joint insights and individual learning. Overall, the complexity was mostly found outside the actual innovation; more specifically, it related to the organization's readiness to integrate new innovations, how to manage and maintain innovations, and how to finance them. The NASSS framework sheds light on various perspectives that can either facilitate or hinder the adoption, scale-up, and spread of technological innovations. In the domain of condition or diagnosis, a well-informed understanding of the complexity related to the condition or illness (diabetes, cancer, bipolar disorders, and schizophrenia disorders) is of great importance for the innovation. The value proposition needs to be clearly described early to enable an understanding of costs and outcomes. The questions in the NASSS complexity assessment tool LONG were sometimes difficult to comprehend, not only from a language perspective but also due to a lack of understanding of the surrounding organization's system and its setting. CONCLUSIONS: Even when bottom-up innovations arise within the same support organization, the complexity can vary based on the developmental phase and the unique characteristics of each project. Identifying, defining, and understanding complexity may not solve the issues but substantially improves the prospects for successful deployment. Successful innovation within complex organizations necessitates an adaptive leadership and structures to surmount cultural resistance and organizational impediments. A rigid, linear, and stepwise approach risks disregarding interconnected variables and dependencies, leading to suboptimal outcomes. Success lies in embracing the complexity with its uncertainty, nurturing creativity, and adopting a nonlinear methodology that accommodates the iterative nature of innovation processes within complex organizations.

Experiences of a Novel Structured Foot Examination Form for Patients With Diabetes From the Perspective of Health Care Professionals: Qualitative Study.

BACKGROUND: Diabetes is a growing threat to public health, and secondary diseases like foot complications are common. Foot ulcers affect the individual's quality of life and are a great cost to society. Regular foot examinations prevent foot ulcers and are a recommended approach both in Sweden and worldwide. Despite existing guidelines, there are differences in the execution of the foot examination, which results in care inequality. A structured foot examination form based on current guidelines was developed in this study as the first step toward digitalized support in the daily routine, and was validated by diabetes health care professionals. OBJECTIVE: The study aimed to validate a structured foot examination form by assessing health care professionals' experiences of working with it "foot side" when examining patients with diabetes. METHODS: Semistructured interviews were held in a focus group and individually with 8 informants from different diabetes professions, who were interviewed regarding their experiences of working with the form in clinical practice. The users' data were analyzed inductively using qualitative content analysis. The study is part of a larger project entitled "Optimised care of persons with diabetes and foot complications," with Västra Götaland Region as the responsible health care authority, where the results will be further developed. RESULTS: Experiences of working with the form were that it simplified the foot examination by giving it an overview and a clear structure. Using the form made differences in work routines between individuals apparent. It was believed that implementing the form routinely would contribute to a more uniform execution. When patients had foot ulcers, the risk categories (established in guidelines) were perceived as contradictory. For example, there was uncertainty about the definition of chronic ulcers and callosities. The expectations were that the future digital format would simplify documentation and elucidate the foot examination, as well as contribute to the accessibility of updated and relevant data for all individuals concerned. CONCLUSIONS: The foot examination form works well as a support tool during preventive foot examination, creates a basis for decision-making, and could contribute to a uniform and safer foot examination with more care equality in agreement with current guidelines. TRIAL REGISTRATION: ClinicalTrials.gov NCT05692778; https://clinicaltrials.gov/ct2/show/NCT05692778.

Clinical guidelines recommending prosthetics and orthotics in Sweden: Agreement between national and regional guidelines.

BACKGROUND: Despite the presence of both national and regional clinical practical guidelines (CPGs) in Sweden, no previous studies have investigated the quality of CPGs or the level of agreement between national and regional CPGs. OBJECTIVES: This study aimed to assess the quality of national CPGs recommending prosthetics and orthotics (P&O) and quantify the agreement between national and regional CPGs in Sweden. STUDY DESIGN: Literature Review. METHODS: National and regional CPGs were identified in public databases and by surveyed local nurse practitioners. Quality of the national guidelines was assessed by using AGREE II. Agreement between recommendations in the national and regional CPGs was quantified on a 4-grade rating scale ("similar," "partially similar," "not similar/not present," and "different"). RESULTS: Of 18 national CPGs, 3 CPGs (CPGs of Diabetes, Musculoskeletal disorders, and Stroke) had 9 recommendations related to P&O. The Musculoskeletal disorders and Stroke CPGs had quality scores .60% in all domains, and the Diabetes CPG had scores .60% in 5 of 6 domains according to AGREE II. Seven regional CPGs for P&O treatment were identified. Three national recommendations (in Diabetes CPGs) showed "similar" content for all regions, and 2 national recommendations (in Diabetes CPGs) showed "not similar" content for all regions. The remaining recommendations (Diabetes, Musculoskeletal disorders, and Stroke CPGs) had varying agreement with regional CPGs. CONCLUSIONS: There is a limited number of national recommendations for treatment within P&O. There was variation in the agreement of P&O-related recommendations in national and regional CPGs, which might lead to unequal care throughout the national healthcare system.

Offloading of diabetes-related neuropathic foot ulcers at Swedish prosthetic and orthotic clinics.

AIMS: This study aimed to assess (1) the use of different offloading interventions in Sweden for the healing of diabetes-related plantar neuropathic forefoot ulcers, (2) factors influencing the offloading intervention choice, and (3) the awareness of current gold standard offloading devices. METHODS: An online questionnaire was distributed via SurveyMonkey to 51 prosthetic and orthotic clinics in Sweden. RESULTS: Thirty-five (69%) practitioners responded to the questionnaire. Eighty-six percent of the practitioners provided modified off-the-shelf footwear combined with insoles to treat diabetes-related plantar neuropathic forefoot ulcers. A total contact cast (TCC) was provided by 20% of the practitioners, and a nonremovable knee-high walker was provided by 0%. Multiple practitioner-, patient-, intervention-, and wound-related factors were considered when practitioners provided offloading interventions to patients with this type of ulcer. The majority of the practitioners did not or were unsure whether they considered TCC or a nonremovable knee-high walker to be the gold standard treatment. CONCLUSIONS: Practitioners mainly provided the offloading intervention that the International Working Group on the Diabetic Foot strongly recommends not be provided, namely, modified off-the-shelf footwear with insoles. In contrast, TCC and nonremovable knee-high walkers, as the gold standards, were vastly underutilised. Therefore, the pattern of providing offloading interventions was almost exactly opposite to the recommendations of evidence-based guidelines. Different factors were considered when providing offloading interventions to patients with diabetes-related plantar neuropathic forefoot ulcers. The practitioners' lack of awareness regarding gold standard devices may have contributed to the underutilisation of TCC and nonremovable knee-high walkers.

Patients' Expectations of Evidence-Based Service at the Pharmacy Regarding Information on Self-Care of the Feet for Persons with Diabetes at Risk of Developing Foot Ulcers - A Cross-Sectional Observational Study in Sweden.

Purpose: Self-care of the feet is one of the cornerstones in the prevention of diabetic foot ulcers (DFU). Often, individuals with diabetes seek help at the pharmacy, but it is still unclear whether the service meets their expectations and needs. The aims were to explore patients' expectations of support from the pharmacy regarding self-care of their feet and explore how patients with diabetes felt that they managed the self-care of their feet. Patients and Methods: The included participants (n = 17), aged 70 ± 9 years, answered surveys regarding their expectations of support from the pharmacy related to self-care of the feet and how they felt that they managed the self-care of their feet. By using software, MyFoot Diabetes, they assessed their risk of developing DFU (ranging from 1 = no risk to 4 = DFU). In addition, a healthcare professional assessed the risk grade. Results: Sixteen patients had not received any information from the pharmacy regarding how to take care of their feet. Several suggestions for ways the pharmacy could help patients with diabetes to take care of their feet were registered. They included having the necessary skills and competence, giving advice regarding self-care, giving information regarding the products they market and have for sale and giving advice on ointments/creams. The participants gave several examples of how they self-managed their feet: by wearing shoes indoors and outdoors, wearing socks and compression stockings as often as possible, being physically active, inspecting their feet, being aware of the fact that their feet have no problems, washing, moisturising their feet, cutting their nails and finally seeking help to prevent DFU. Conclusion: The participants thought that they should receive competent information from the personnel at the pharmacy to improve the self-care of their feet, eg, being given information about which ointments/creams to use. Clinical Trial: NCT05692778.

Measuring sustainability in healthcare: an analysis of two systems providing insoles to patients with diabetes.

There is an increasing demand to quantify the footprints, ecological, economic and social, in terms of the effect of different interventions in healthcare. The aim of this study was to compare two systems providing patients with diabetes with insoles in terms of their ecological, economic and social footprints. Prefabricated insoles (PRI) were compared with custom-made insoles (CMI). Using a welfare-economic monetary approach, costs were estimated for (1) treatment, (2) travelling to and from the hospital in terms of both fuel and time consumed by the patients and (3) society through emissions contributing to climate change. The proportion of patients/year that could be supplied within the same budget, for each individual treatment, was calculated. The cost of the insoles was 825 SEK (PRI) and 1450 SEK (CMI), respectively. The cost, mean value/patient due to the consumption of patients' time at the department, was 754 SEK (PRI) and 1508 SEK (CMI), respectively. Emissions, in terms of CO2 equivalent, were 13.7 (PRI) and 27.4 (CMI), respectively. Using PRI, a total of 928 patients could be provided/year compared with 500 patients if CMI are used. By using PRI, the cost/treatment was reduced by 46%. The cost of treatment dominated and the cost of time consumed by patients were also substantial. The societal cost of contributing to climate change was of low importance. By using PRI, the needs of 86% more patients could be met within the same budget. Using these methods, the contribution of healthcare systems to the 17 Sustainable Development Goals approved by the UN can be quantified.

Nordic clinical guidelines for orthotic treatment of osteoarthritis of the knee: A systematic review using the AGREE II instrument.

BACKGROUND: High-quality clinical practice guidelines are necessary for effective use of resources both at an individual patient- and national-level. Nordic clinical practice guidelines recommendations for orthotic treatment of knee osteoarthritis vary and little is known about their quality. OBJECTIVES: The aim of the study was to critically evaluate the quality of clinical practice guidelines in orthotic management of knee osteoarthritis in the Nordic countries. STUDY DESIGN: Systematic review. METHODS: Four national clinical practice guidelines for treatment of knee osteoarthritis were assessed for methodological rigour and transparency by four independent assessors using the AGREE II instrument. Summary domain scores and inter-rater agreement (Kendall's W) were calculated. RESULTS: Domain scores indicate that many guidelines have not sufficiently addressed stakeholder involvement (average score: 55%), applicability (20%) and editorial independence (33%) in the development process. Inter-rater agreement for assessors indicated 'good' agreement for clinical practice guidelines from Finland, Norway and Sweden (W = 0.653, p < 0.001; W = 0.512, p = 0.003 and W = 0.532, p = 0.002, respectively) and 'strong' agreement for the clinical practice guideline from Denmark (W = 0.800, p < 0.001). CONCLUSION: Quality of clinical practice guidelines for orthotic treatment of knee osteoarthritis in the Nordic region is variable. Future guideline development should focus on improving methodology by involving relevant stakeholders (e.g. certified prosthetist/orthotists (CPOs)), specifying conflicts of interest and providing guidance for implementation. CLINICAL RELEVANCE: The current review suggests that, for the Nordic region, there are areas of improvement which can be addressed, which ensure clinical practice guidelines are developed under stringent conditions and based on sound methods. These improvements would ensure knee osteoarthritis patients are receiving orthotic interventions based on appropriate guidance from published guidelines.

Comparison of plantar pressure in three types of insole given to patients with diabetes at risk of developing foot ulcers - A two-year, randomized trial.

BACKGROUND: Special insoles and shoes designed to prevent foot ulcers caused by repetitive high pressures are recommended for patients with diabetes who have any of the following risk factors: neuropathy; peripheral vascular disease; foot deformities; previous ulcers; amputation; and skin pathologies. However, there is a need for increased knowledge regarding: a) differences in the peak pressure (PP) and pressure time integral (PTI) for different types of insoles; and b) the properties of the pressure distribution for insoles used over a period of several months. We present the results of a randomized trial to compare the plantar pressures of three commonly used insoles. OBJECTIVES: The primary objective was to compare the PP and PTI between three types of insoles. The secondary objective was to explore the long-term pattern of peak plantar pressure distribution and variations in specific regions of interest (ROI). The tertiary objective was to investigate the impacts of insole adjustments, how much the insoles were used, and the levels of patient satisfaction. METHODS: In a 2-year trial, 114 patients with type 1 (N = 31) or type 2 (N = 83) diabetes (62 men and 52 women; mean age, 57.7 ± 15.4 years; duration of diabetes, 12.3 ± 11.2 years; neuropathy, 38%), were randomized to be supplied with one of three different insoles. The ethylene vinyl acetate (EVA) insoles were used in outdoor walking shoes. The 35 EVA group (N = 39) received soft custom-made insoles composed of EVA of 35 shore A hardness, the 55 EVA group (N = 37) received custom-made insoles composed of EVA of 55 shore hardness, and the control group (N = 38) received prefabricated insoles composed of a hard core with a top layer of soft 12 shore hardness microfiber. Using F-Scan®, the in-shoe plantar pressures were measured at seven ROI (hallux, metatarsal head 1, metatarsal head 2, metatarsal head 4, metatarsal head 5, lateral aspect of the mid-foot, heel) on five occasions during the study period. The plantar-pressure variables used were PP (main outcome) and PTI. The plantar patterns of load were explored, satisfaction and usage of the insoles were rated by the participants, and insole adjustments were recorded. RESULTS: A mixed model analysis estimated lower PP values in the heel regions for the 35 EVA and 55 EVA insoles (171 ± 13 and 161 ± 13 kPa, respectively) than for the prefabricated insoles (234 ± 10 kPa) (p < 0.001). Also for some of the other six ROI indications of difference in PP or PTI could be observed. The redistribution of peak plantar pressure for all of the insoles, was stable at the mid-foot, while the proportion of load on the distal area changed during the study period According to the self-reported answers (scale, 0-100), the average usage of the insoles was rated as 79 and satisfaction was rated as 85 (N = 75). Thirty-two percent of the subjects had not received foot care. Fourteen adjustments to insoles were made during the study period, and 86 pairs of insoles were exchanged due to wear, with 49% being exchanged in the 35 EVA group. CONCLUSIONS: Custom-made insoles used in combination with stable walking shoes gave lower pressures at the heel region. The variation makes it difficult to detect a systematic difference in plantar pressure for the 6 ROI, if such a difference indeed exists. The levels of satisfaction and usage for all the insoles tested were high. The insoles maintained their pressure redistribution properties over long periods, and few adjustments were needed.