Evidence-based interventions for identifying candidate quality indicators to assess quality of care in diabetic foot clinics: a scoping review.

BACKGROUND: Foot ulcers in people with diabetes are a serious complication requiring a complex management and have a high societal impact. Quality monitoring systems to optimize diabetic foot care exist, but a formal and more evidence-based approach to develop quality indicators (QIs) is lacking. We aimed to identify a set of candidate indicators for diabetic foot care by adopting an evidence-based methodology. METHODS: A systematic search was conducted across four academic databases: PubMed, Embase CINAHL and Cochrane Library. Studies that reported evidence-based interventions related to organization or delivery of diabetic foot care were searched. Data from the eligible studies were summarized and used to formulate process and structure indicators. The evidence for each candidate QI was described in a methodical and transparent manner. The review process was reported according to the "Preferred Reported Items for Systematic reviews and Meta-Analysis" (PRISMA) statements and its extension for scoping reviews. RESULTS: In total, 981 full-text articles were screened, and 322 clinical studies were used to formulate 42 candidate QIs. CONCLUSIONS: An evidence-based approach could be used to select candidate indicators for diabetic foot ulcer care, relating to the following domains: wound healing interventions, peripheral artery disease, offloading, secondary prevention, and interventions related to organization of care. In a further step, the feasibility of the identified set of indicators will be assessed by a multidisciplinary panel of diabetic foot care stakeholders.

A multidisciplinary Delphi consensus to define evidence-based quality indicators for diabetic foot ulcer care.

BACKGROUND: Valid measures to assess quality of care delivered to patients with diabetes suffering from diabetic foot ulcer (DFU) are scarce. This study aimed to achieve consensus on relevant and feasible quality indicators (QIs) among stakeholders involved in DFU care and was conducted as the second part of a Belgian QI selection study that sought to identify QIs for DFU care. METHODS: A stakeholder panel, including caregivers from primary care and specialized disciplines active in diabetic foot care as well as a patient organization representative, was recruited. By using the RAND/UCLA Appropriateness Method, stakeholders were asked to rate a list of 42 candidate evidence-based indicators for appropriateness through a 9-point Likert scale. QIs were classified based on the median ratings and the disagreement index, calculated by the inter-percentile range adjusted for symmetry. RESULTS: At the end of a three-phase process, 17 QIs were judged as appropriate. Among them, five were not previously described, covering the following topics: integration of wound care specialty in the multidisciplinary team, systematic evaluation of the nutritional status of the patient, administration of low-density lipoprotein-cholesterol lowering medication and protocolized care (implementation of care and prevention management protocols). CONCLUSIONS: The identified evidence-based QIs provide an assessment tool to evaluate and monitor quality of care delivered to DFU patients. Future research should focus on their complementarity with the existing QIs and their implementation in clinical practice.

Bottom-up approach to build a 'precision' risk factor classification for diabetic foot ulcer healing. Proof-of-concept.

AIMS: Diabetic foot ulcers (DFU) have a complex multifactorial pathophysiology. It is crucial to identify essential prognostic variables to streamline therapeutic actions and quality-of-care audits. Although SINBAD and University of Texas (UT), the most frequently used prognostic classification systems, were prospectively validated, not all individual parameters were shown to have consistent associations with healing. In this study, we used a bottom-up approach relying on robust methods to identify independent predictors of DFU healing. METHODS: 1,664 DFU patients were included by 34 Belgian diabetic foot clinics (DFCs). Twenty-one patient- and foot-related characteristics were recorded at presentation. Predictors of healing were identified using multivariable Cox proportional hazard regression. Multivariable models were built using backward regression with multiple imputation of missing values and bootstrapping. RESULTS: Five essential independent variables were identified: presentation delay, history of minor amputation, ulcer location, surface area and ischemia. This 5 variable-model showed a better performance compared to models based on existing classification systems. CONCLUSIONS: A bottom-up approach was used to build a prognostic classification for DFU healing based on large databases. It offers new insights and allows to tailor the classification to certain clinical settings. These 5 parameters could be used as a 'precision classification' for specialized DFCs.

Health-related quality of life in patients with diabetic foot ulceration: study protocol for adaptation and validation of patient-reported outcome measurements (PROMs) in Dutch-speaking patients.

INTRODUCTION: Diabetic foot ulceration (DFU) is a common late-stage complication of diabetes with a large impact on health status and quality of life. Patient-reported outcome measures (PROMs) provide a standardised method of obtaining patients' views on their well-being. The DFU Scale Short Form (DFS-SF) is a validated disease-specific PROM for measuring health-related quality of life among DFU patients. The Lower Extremity Functional Scale (LEFS) is another PROM that can be used to measure physical functioning in patients with lower extremity disorders. The LEFS is not yet validated for DFU. Both instruments are not validated in the Dutch language. The purpose of this study is to culturally adapt and validate the DFS-SF and LEFS questionnaires for Belgian Dutch-speaking patients with DFU. METHODS AND ANALYSIS: This study will be conducted as a monocentre observational cohort study in DFU patients presenting at a hospital-based multidisciplinary diabetic foot clinic. Data will be collected from the medical electronic files and from DFS-SF, LEFS and five-level EuroQol five-dimension questionnaires that will be presented to the patients at defined time points. Reproducibility, internal consistency, floor and ceiling effects, construct validity and responsiveness will be assessed for the DFS-SF and LEFS. ETHICS AND DISSEMINATION: The study protocol has been approved by the Medical Ethics Committee of Onze-Lieve-Vrouw Hospital (Aalst, Belgium). The results of the study will be disseminated through peer-reviewed publications and conference presentations.