Dataset Information

The Validity and Reliability of Self-Reported Adherence to Using Offloading Treatment in People with Diabetes-Related Foot Ulcers.

ABSTRACT: Adherence to using offloading treatment is crucial to healing diabetes-related foot ulcers (DFUs). Offloading adherence is recommended to be measured using objective monitors. However, self-reported adherence is commonly used and has unknown validity and reliability. This study aimed to assess the validity and reliability of self-reported adherence to using removable cast walker (RCW) offloading treatment among people with DFUs. Fifty-three participants with DFUs using RCWs were included. Each participant self-reported their percentage adherence to using their RCW of total daily steps. Participants also had adherence objectively measured using dual activity monitors. After one week, a subset of 19 participants again self-reported their percentage adherence to investigate test-retest reliability. Validity was tested using Pearson's r and Bland-Altman tests, and reliability using Cohen's kappa. Median (IQR) self-reported adherence was greater than objectively measured adherence (90% (60-100) vs. 35% (19-47), p < 0.01). There was fair agreement (r = 0.46; p < 0.01) and large 95% limits of agreement with significant proportional bias (β = 0.46, p < 0.01) for validity, and minimal agreement for test-retest reliability (K = 0.36; p < 0.01). The validity and reliability of self-reported offloading adherence in people with DFU are fair at best. People with DFU significantly overestimate their offloading adherence. Clinicians and researchers should instead use objective adherence measures.

SUBMITTER: Ababneh A

PROVIDER: S-EPMC10181495 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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The Validity and Reliability of Self-Reported Adherence to Using Offloading Treatment in People with Diabetes-Related Foot Ulcers.

Ababneh Anas A Finlayson Kathleen K Edwards Helen H Armstrong David G DG Najafi Bijan B van Netten Jaap J JJ Lazzarini Peter A PA

Sensors (Basel, Switzerland) 20230430 9

Adherence to using offloading treatment is crucial to healing diabetes-related foot ulcers (DFUs). Offloading adherence is recommended to be measured using objective monitors. However, self-reported adherence is commonly used and has unknown validity and reliability. This study aimed to assess the validity and reliability of self-reported adherence to using removable cast walker (RCW) offloading treatment among people with DFUs. Fifty-three participants with DFUs using RCWs were included. Each p ...[more]

PMID: 37177627

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Project description:BackgroundOffloading devices improve healing of diabetes-related foot ulcers (DFUs) but they can limit mobilisation. Rehabilitation during or after removal of these devices may promote physical activity in a population at risk of poor health outcomes for which inactivity is a reversible risk factor.MethodsThis systematic review examined the effectiveness of rehabilitation interventions to promote physical activity during and/or after wearing an offloading device to treat diabetes-related foot ulcers. Searches using MESH terms and free-text combinations: 'foot ulcer', 'diabetic foot', 'casts, surgical', 'orthotic devices' were applied to MEDLINE, Embase, The Cochrane Library and clinical trial registers for randomised and observational studies published to September 2022. Methodological quality assessment of included studies was undertaken using the Cochrane Risk of Bias (RoB 2.0) and Risk of Bias In Non-randomised studies of Interventions (ROBINS-I) tools.ResultsOf 3332 records identified, eight studies (441 participants), four clinical trials and four cohort studies, were included. None delivered or tested a structured rehabilitation programme, but all reported physical activity outcomes during or after device use. People wearing non-removable total contact casts were less active than those wearing devices (SMD -0.45; 95% CI - 0.87 to - 0.04; p = 0.03; I2 56%; 4 trials). Diabetes-related foot ulcers in people wearing total contact casts were more likely to heal compared to removable devices at 12 weeks (OR 2.69; 95% CI 0.97 to 7.45; p = 0.06; I2 = 64%; 4 trials) and 20 weeks (OR 2.35; 95% CI 0.95 to 5.82; p = 0.07; I2 = 65%; 4 trials).ConclusionsDespite physical activity being low throughout off-loading treatment, no studies have specifically tested rehabilitation. There is a need to investigate the clinical and cost-effectiveness of rehabilitation programmes in this population. High quality trials are needed to provide robust evidence to support to rehabilitation after DFU treatment.

Project description:BackgroundOffloading interventions are commonly used in clinical practice to heal foot ulcers. The aim of this updated systematic review is to investigate the effectiveness of offloading interventions to heal diabetic foot ulcers.MethodsWe updated our previous systematic review search of PubMed, EMBASE, and Cochrane databases to also include original studies published between July 29, 2014 and August 13, 2018 relating to four offloading intervention categories in populations with diabetic foot ulcers: (a) offloading devices, (b) footwear, (c) other offloading techniques, and (d) surgical offloading techniques. Outcomes included ulcer healing, plantar pressure, ambulatory activity, adherence, adverse events, patient-reported measures, and cost-effectiveness. Included controlled studies were assessed for methodological quality and had key data extracted into evidence and risk of bias tables. Included non-controlled studies were summarised on a narrative basis.ResultsWe identified 41 studies from our updated search for a total of 165 included studies. Six included studies were meta-analyses, 26 randomised controlled trials (RCTs), 13 other controlled studies, and 120 non-controlled studies. Five meta-analyses and 12 RCTs provided high-quality evidence for non-removable knee-high offloading devices being more effective than removable offloading devices and therapeutic footwear for healing plantar forefoot and midfoot ulcers. Total contact casts (TCCs) and non-removable knee-high walkers were shown to be equally effective. Moderate-quality evidence exists for removable knee-high and ankle-high offloading devices being equally effective in healing, but knee-high devices have a larger effect on reducing plantar pressure and ambulatory activity. Low-quality evidence exists for the use of felted foam and surgical offloading to promote healing of plantar forefoot and midfoot ulcers. Very limited evidence exists for the efficacy of any offloading intervention for healing plantar heel ulcers, non-plantar ulcers, and neuropathic ulcers with infection or ischemia.ConclusionStrong evidence supports the use of non-removable knee-high offloading devices (either TCC or non-removable walker) as the first-choice offloading intervention for healing plantar neuropathic forefoot and midfoot ulcers. Removable offloading devices, either knee-high or ankle-high, are preferred as second choice over other offloading interventions. The evidence bases to support any other offloading intervention is still weak and more high-quality controlled studies are needed in these areas.

Project description:BackgroundPressure offloading treatment is critical for healing diabetes-related foot ulcers (DFU). Yet the 2011 Australian DFU guidelines regarding offloading treatment are outdated. A national expert panel aimed to develop a new Australian guideline on offloading treatment for people with DFU by adapting international guidelines that have been assessed as suitable to adapt to the Australian context.MethodsNational Health and Medical Research Council procedures were used to adapt suitable International Working Group on the Diabetic Foot (IWGDF) guidelines to the Australian context. We systematically screened, assessed and judged all IWGDF offloading recommendations using best practice ADAPTE and GRADE frameworks to decide which recommendations should be adopted, adapted or excluded in the Australian context. For each recommendation, we re-evaluated the wording, quality of evidence, strength of recommendation, and provided rationale, justifications and implementation considerations, including for geographically remote and Aboriginal and Torres Strait Islander peoples. This guideline, along with five accompanying Australian DFU guidelines, underwent public consultation, further revision and approval by ten national peak bodies (professional organisations).ResultsOf the 13 original IWGDF offloading treatment recommendations, we adopted four and adapted nine. The main reasons for adapting the IWGDF recommendations included differences in quality of evidence ratings and clarification of the intervention(s) and control treatment(s) in the recommendations for the Australian context. For Australians with plantar DFU, we recommend a step-down offloading treatment approach based on their contraindications and tolerance. We strongly recommend non-removable knee-high offloading devices as first-line treatment, removable knee-high offloading devices as second-line, removable ankle-high offloading devices third-line, and medical grade footwear as last-line. We recommend considering using felted foam in combination with the chosen offloading device or footwear to further reduce plantar pressure. If offloading device options fail to heal a person with plantar DFU, we recommend considering various surgical offloading procedures. For people with non-plantar DFU, depending on the type and location of the DFU, we recommend using a removable offloading device, felted foam, toe spacers or orthoses, or medical grade footwear. The six new guidelines and the full protocol can be found at: https://diabetesfeetaustralia.org/new-guidelines/ .ConclusionsWe have developed a new Australian evidence-based guideline on offloading treatment for people with DFU that has been endorsed by ten key national peak bodies. Health professionals implementing these offloading recommendations in Australia should produce better DFU healing outcomes for their patients, communities, and country.

Project description:BackgroundIt has been reported that ozone therapy might be helpful in treating foot ulcers in people with diabetes mellitus (DM).ObjectivesTo assess the effects of ozone therapy on the healing of foot ulcers in people with DM.Search methodsIn March 2015 we searched: The Cochrane Wounds Group Specialised Register, The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), Ovid MEDLINE, Ovid MEDLINE (In-Process & Other Non-Indexed Citations), Ovid EMBASE, EBSCO CINAHL, Science Citation Index, Chinese Biomedical Literature Database and The Chinese Clinical Registry. There were no restrictions based on language, date or study setting.Selection criteriaWe included randomised controlled trials (RCTs) that compared ozone therapy with sham ozone therapy or any other interventions for foot ulcers in people with DM, irrespective of publication date or language.Data collection and analysisTwo reviewers independently screened all retrieved citations, selected relevant citations and extracted data. Disagreements were resolved by discussion with a third reviewer. The methodological quality of included studies and the evidence level of outcomes were assessed using the Cochrane risk of bias tool and the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach respectively. Data were expressed using risk ratio (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes with their 95% confidence interval (95% CI). Review Manager (RevMan) software was used to analyse the data.Main resultsThree studies (212 participants) were included in this review. The overall risk of bias was high for two trials and unclear for one.One trial (101 participants) compared ozone treatment with antibiotics for foot ulcers in people with DM. The study had a follow-up period of 20 days. This study showed that ozone treatment was associated with a greater reduction in ulcer area from baseline to the end of the study than treatment with antibiotics (MD -20.54 cm(2), 95% CI -20.61 to -20.47), and a shorter duration of hospitalisation (MD -8.00 days, 95% CI -14.17 to -1.83), but did not appear to affect the number of ulcers healed over 20 days (RR 1.10, 95% CI 0.87 to 1.40). No side effects were observed in either group.The other two trials (111 participants) compared ozone treatment plus usual care with usual care for foot ulcers in people with DM. The meta-analysis results did not show evidence of a difference between groups for the outcomes of reduction of ulcer area (MD -2.11 cm(2), 95% CI -5.29 to 1.07), the number of ulcers healed (RR 1.69, 95% CI 0.90 to 3.17), adverse events (RR 2.27, 95% CI 0.48 to 10.79), or amputation rate (RR 2.73, 95%CI 0.12, 64.42).Authors' conclusionsThe available evidence was three small RCTs with unclear methodology, so we are unable to draw any firm conclusions regarding the effectiveness of ozone therapy for foot ulcers in people with DM.

Project description:IntroductionComprehensive regular foot self-care is one of the most critical self-management behaviors for people with diabetes to prevent foot ulcer development and related complications. Yet, adequate foot self-care is only practiced by very few of those affected. To improve diabetic foot syndrome prevention, a valid and reliable instrument for measuring daily foot-care routines in patients with diabetes is needed. However, no such instrument is currently available in the German language. This study, therefore, aims to translate and cross-culturally adapt the "Diabetic Foot Self-Care Behavior Scale" (DFSBS) into German (DFSBS-D) and evaluate its validity and reliability.Material and methodsThe DFSBS was translated from English into German using a forward-backward procedure as per previous recommendations. Factor analysis was used to study structural validity. To establish construct validity, 21 a priori hypotheses were defined regarding the expected correlation between scores on the new German version (i.e., DFSBS-D) and those of the following questionnaires measuring related constructs: (1) German version "Diabetes Self-Care Activities Measure" (SDSCA-G), (2) "Frankfurter Catalogue of Foot Self-Care" (FCFSP), and (3) "Short Form 36" (SF-36) and tested in 82 patients. To assess test-retest reliability, patients completed the DFSBS-D again after a 2-week interval. Test-retest reliability was assessed from stable patients' data (n = 48) by calculating two-way random-effects absolute agreement ICCs with 95% CI and Bland and Altman analyses. In addition, Cronbach's alpha was calculated as internal consistency measure.ResultsThe 7-item DFSBS-D showed good structural validity. Its single factor explains 57% of the total sample variance. Of the 21 predefined hypotheses, 13 (62%) were confirmed. The DFSBS-D's internal consistency was good (Cronbach's alpha = 0.87). Test-retest reliability over a 2-week interval was also good (ICC 0.76).ConclusionThe DFSBS was successfully translated into German. Statistical analyses showed good DFSBS-D structural validity, test-retest reliability, and internal consistency. Yet, construct validity may be debated.

Dataset Information

The Validity and Reliability of Self-Reported Adherence to Using Offloading Treatment in People with Diabetes-Related Foot Ulcers.

Publications

The Validity and Reliability of Self-Reported Adherence to Using Offloading Treatment in People with Diabetes-Related Foot Ulcers.

Similar Datasets

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