Cross-cultural adaptation and validation of the Foot Function Index to Spanish.

BACKGROUND: The purpose of this study was to adapt and validate the Foot Function Index to the Spanish (FFI-Sp) following the guidelines of the American Academy of Orthopaedic Surgeons. METHODS: A cross-sectional study 80 participants with some foot pathology. A statistical analysis was made, including a correlation study with other questionnaires (the Foot Health Status Questionnaire, EuroQol 5-D, Visual Analogue Pain Scale, and the Short Form SF-12 Health Survey). Data analysis included reliability, construct and criterion-related validity and factor analyses. RESULTS: The principal components analysis with varimax rotation produced 3 principal factors that explained 80% of the variance. The confirmatory factor analysis showed an acceptable fit with a comparative fit index of 0.78. The FFI-Sp demonstrated excellent internal consistency on the three subscales: pain 0.95; disability 0.96; and activity limitation 0.69, the subscale that scored lowest. The correlation between the FFI-Sp and the other questionnaires was high to moderate. CONCLUSIONS: The Spanish version of the Foot Function Index (FFI-Sp) is a tool that is a valid and reliable tool with a very good internal consistency for use in the assessment of pain, disability and limitation of the function of the foot, for use both in clinic and research.

Statin use and lower extremity amputation risk in nonelderly diabetic patients.

OBJECTIVE: To examine the association between use of statin and nonstatin cholesterol-lowering medications and risk of nontraumatic major lower extremity amputations (LEAs) and treatment failure (LEA or death). METHODS: A retrospective cohort of patients with Type I and Type 2 diabetes mellitus (diabetes) was followed for 5 years between 2004 and 2008. The follow-up exposure duration was divided into 90-day periods. Use of cholesterol-lowering agents, diabetic medications, hemoglobin A1c, body mass index, and systolic and diastolic blood pressures were observed in each period. Demographic factors were observed at baseline. Major risk factors of LEA including peripheral neuropathy, peripheral artery disease, and foot ulcers were observed at baseline and were updated for each period. LEA and deaths were assessed in each period and their hazard ratios (HRs) were estimated. The study took place in the U.S. Department of Veterans Affairs Healthcare system, and the subjects consisted of cholesterol drug-naïve patients with Type I or II diabetes who were treated in the U.S. Department of Veterans Affairs Healthcare system in 2003 and were <65 years old at the end of follow-up. RESULTS: Of 83,953 patients in the study cohort, 217 (0.3%) patients experienced a major LEA and 11,716 (14.0%) patients experienced an LEA or death (treatment failure) after a mean follow-up of 4.6 years. Compared with patients who did not use cholesterol-lowering agents, statin users were 35% to 43% less likely to experience an LEA (HR, 0.65; 95% confidence interval [CI], 0.42-0.99) and a treatment failure (HR, 0.57; 95% CI, 0.54-0.60). Users of other cholesterol-lowering medications were not significantly different in LEA risk (HR, 0.95; 95% CI, 0.35-2.60) but had a 41% lower risk of treatment failure (HR, 0.59; 95% CI, 0.51-0.68). CONCLUSIONS: This is the first study to report a significant association between statin use and diminished amputation risk among patients with diabetes. In this nonrandomized cohort, beneficial effects of statin therapy were similar to that seen in large-scale clinical trial experience. For LEA risk, those given nonstatins did not have a statistically significant benefit and its effect on LEA risk was much smaller compared with statins. Unanswered questions to be explored in future studies include a comparison of statins of moderate vs high potency in those with high risk of coronary heart disease and an exploration of whether the effects seen in this study are simply effects of cholesterol-lowering or possibly pleiotropic effects.

The Importance of Foot Function Assessment Using the Foot Function Index-Revised Short Form (FFI-RS) Questionnaire in the Comprehensive Treatment of Patients with Rheumatoid Arthritis.

BACKGROUND: Foot problems may have a substantial negative impact on rheumatoid arthritis (RA) patients' mobility. They affect walking and the functional capacity to perform daily tasks. METHODS: This study included 61 patients with RA and foot pain or swelling. The study group comprised 37 patients (aged 54.3 ± 9.5 years) with foot lesions, as demonstrated in an ultrasound, and the control group comprised 24 patients (aged 57.3 ± 11.5 years) without foot lesions. The patients' health statuses were evaluated with the Foot Function Index-Revised Short Form (FFI-RS), the Polish version of the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the Disease Activity Score 28 (DAS 28). RESULTS: The FFI-RS showed significant differences between the study and control groups in total results, as well as in the pain and stiffness subscales. Subsequent analyses showed numerous significant correlations. The FFI-RS total results correlated with the HAQ's standing up, walking, and total results. The FFI-RS pain results correlated with the social issues and HAQ's total results. The FFI-RS difficulty results correlated with the disease's duration. In the study group, there were significant correlations of the FFI-RS stiffness, difficulty, and social issues results with the HAQ's standing up, walking, and total results, and also of the FFI-RS activity limitation results with the HAQ's standing up results. In the control group, there were correlations of the FFI-RS stiffness, difficulty, and activity limitation results with the HAQ's walking and total results. Finally, in the study group, we also found correlations of the FFI-RS total, pain, stiffness, difficulty, and social issues results with the Visual Analog Scale (VAS) results, as well as of the FFI-RS total results with the DAS 28 results. CONCLUSIONS: The FFI-RS is an effective tool for assessing RA patients' functional status and can be used to evaluate treatment effects. The FFI-RS detected RA-related changes in the foot joint function in patients without foot lesions, as assessed by ultrasound.

Significant J-shaped association between body mass index (BMI) and diabetic foot ulcers.

BACKGROUND: Disagreement exists regarding the relationship between body weight and foot ulceration risk among diabetic persons. METHODS: We used a nested case-control design to estimate the association between body mass index (BMI) and 1-year and 5-year foot ulceration risk. We obtained data on all diabetic patients < 60 years of age who were treated in the US Department of Veterans Affairs healthcare system in 2003. Patient characteristics and co-morbidities were obtained at baseline. For each individual with an incident foot ulcer (case), up to four individuals were randomly selected who matched the case on age, sex, race, marital status, and calendar time. RESULTS: Crude 1-year and 5-year incidence rates were 1.35 and 6.22% after a mean follow-up of 11.8 ± 1.2 months and 55.5 ± 12.8 months, respectively. Compared with individuals with BMI 25-29.9 kg/m(2) , those with BMI 40-44.9 kg/m(2) and those with BMI ≥ 45 kg/m(2) had 25% [adjusted odds ratio (AOR) = 1.25; 95% confidence interval (CI), 1-1.56] and 83% (AOR = 1.83; 95% CI, 1.44-2.32) higher 1-year risk and 1.4 (AOR = 1.39; 95% CI, 1.26-1.54) and 2.1 (AOR = 2.08; 95% CI, 1.86-2.32) times higher 5-year risk. BMI < 25 kg/m(2) was associated with 30% higher risk at both 1 year (AOR = 1.28; 95% CI, 1.04-1.58) and 5 years (AOR = 1.27; 95% CI, 1.15-1.40). CONCLUSIONS: Our data suggest a significant J-shaped association between BMI and diabetic foot ulcers.

Increasing SBP variability is associated with an increased risk of developing incident diabetic foot ulcers.

OBJECTIVE: SBP variability may be a target for mitigating end-organ damage associated with vascular disease. We evaluated the relationship between increased SBP variability and risk of incident diabetic foot ulceration. METHODS: Using a nested case-control design, we followed patients diagnosed with diabetes and treated within the US Department of Veterans Affairs Healthcare system for development of a diabetic foot ulcer (event) between 2006 and 2010. Each case was randomly matched to up to five controls based on age, sex, race/ethnicity, and calendar time. SBP variability was computed using at least three blood pressure measurements from the year preceding the event. The association between SBP variability and foot ulceration was examined using conditional logistic regression. Potential protective effects of calcium channel blockers, which blunt SBP variability, were also explored. RESULTS: The study sample included 51 111 cases and 129 247 controls. Compared with those in quartile 1 (lowest variability), patients in quartiles 2-4 had higher adjusted odds ratios for diabetic foot ulcer development: 1.11 (95% CI 1.07-1.16), 1.20 (95% CI 1.15-1.25), 1.29 (95% CI 1.24-1.34) (P for trend <0.001). Calcium channel blockers were associated with reduced risks of ulceration for those without peripheral vascular disease (OR = 0.87, 95% CI 0.84-0.90, P < 0.001) or neuropathy (OR = 0.85, 95% CI 0.82-0.89, P < 0.001) in adjusted subgroup analyses. CONCLUSION: This study describes a graded relationship between SBP variability and risk of diabetic foot ulceration, providing a potential new and modifiable target to reduce this common complication.

Translation and cultural adaptation of the revised foot function index for the Portuguese language: FFI-R Brazil.

BACKGROUND: The revised foot function index (FFI-R) is used to evaluate the functionality of patients with conditions that affect the feet. The objective here was to produce the Brazilian Portuguese version of this index. DESIGN AND SETTING: Translation and validation study conducted at the Federal University of São Paulo, Brazil. METHODS: The translation and cultural adaptation process involved translation by two independent translators, analysis by an expert committee, back translation into the original language, analysis by the expert committee again and a pretest. The Portuguese-language version was administered to 35 individuals with plantar fasciitis and metatarsalgia to determine their level of understanding of the assessment tool. RESULTS: Changes were made to the terms and expressions of some original items to achieve cultural equivalence. Terms not understood by more than 10% of the sample were altered based on the suggestions of the patients themselves. CONCLUSION: The translation and cultural adaptation of the FFI-R for the Portuguese language were completed and the Brazilian version was obtained.

Visit-to-visit systolic blood pressure variability and microvascular complications among patients with diabetes.

AIMS: To examine the relationship between systolic blood pressure (SBP) variability and the risk of microvascular complications in a non-elderly diabetic population. METHODS: This is a retrospective cohort study of individuals aged ≤60years treated for diabetes in 2003 in the US Department of Veterans Affairs healthcare system. Individuals were followed for five years for any new diagnosis of diabetic nephropathy, retinopathy, or neuropathy. In each year of follow-up, individuals were classified into quartiles based on their SBP variability. RESULTS: We identified 208,338 patients with diabetes without diabetic nephropathy, retinopathy, or neuropathy at baseline. Compared to individuals with the least SBP variability (Quartile 1), those with most variability (Quartile 4) had 81% (OR=1.81; 95% CI, 1.72-1.91), 17% (OR=1.17; 95% CI, 1.13-1.21), 30% (OR=1.30; 95% CI, 1.25-1.35), and 19% (OR=1.19; 95% CI, 1.15-1.23) higher incidence of nephropathy, retinopathy, neuropathy, and any complication, respectively, after adjusting for mean SBP, demographic and clinical factors. CONCLUSIONS: We found a significant graded relationship between SBP variability and the incidence of each complication and of any combined endpoint. This is the first study showing a significant association between SBP variability and the risk of diabetic retinopathy and neuropathy.

Adaptation and Validation of the Foot Function Index-Revised Short Form into Polish.

PURPOSE: The aim of the present study was to adapt the Foot Function Index-Revised Short Form (FFI-RS) questionnaire into Polish and verify its reliability and validity in a group of patients with rheumatoid arthritis (RA). METHODS: The study included 211 patients suffering from RA. The FFI-RS questionnaire underwent standard linguistic adaptation and its psychometric parameters were investigated. The enrolled participants had been recruited for seven months as a convenient sample from the rheumatological hospital in Srem (Poland). They represented different sociodemographic characteristics and were characterized as rural and city environments residents. RESULTS: The mean age of the patients was 58.9 ± 10.2 years. The majority of patients (85%) were female. The average final FFI-RS score was 62.9 ± 15.3. The internal consistency was achieved at a high level of 0.95 in Cronbach's alpha test, with an interclass correlation coefficient ranging between 0.78 and 0.84. A strong correlation was observed between the FFI-RS and Health Assessment Questionnaire-Disability Index (HAQ-DI) questionnaires. CONCLUSION: The Polish version of FFI-RS-PL indicator is an important tool for evaluating the functional condition of patients' feet and can be applied in the diagnosis and treatment of Polish-speaking patients suffering from RA.

Theoretical model and Rasch analysis to develop a revised Foot Function Index.

BACKGROUND: The Foot Function Index (FFI) is a widely used self-reported measure of health-related foot function. Several areas have been identified for potential improvement, and this study responds to such criticisms. The objectives of this study were to: (1) develop a theoretical model of foot functioning, (2) develop a revised FFI (FFI-R), and (3) field-test the FFI-R. METHODS: A literature review was conducted to develop the theoretical model. The FFI-R items were developed from the original 23 FFI items, and more items were added as a result of the literature review. A focus group discussion with clinicians and pilot interviews with patients resulted in a final draft of the FFI-R. This draft consisted of four subscales and comprised 68 items with a six-point response scale. The FFI-R was field tested on 92 patients in the podiatry clinic of a Veterans Administration Hospital in the Midwest. Psychometric analyses were conducted with modern item response theory (IRT) methods. RESULTS: A theoretical model of foot functioning was developed. The FFI-R response scale was revised from six to five categories since confusion was found between categories 4 and 5. Rasch analyses indicated a person reliability of 0.96 and item reliability of 0.93. The subscale reliability of pain and stiffness, psychosocial, and disability were all >0.80; the exception was assistive devices (>0.50). Construct validity of FFI-R was supported based on the correlation of 50-ft walk time with an FFI-R total of 0.306, p = 0.018, N = 59. Rasch analyses indicated several items with poor fit statistics and a short form with 34 items was developed. CONCLUSION: The FFI was revised, and new items were added to compose the FFI-R. The chief theoretical change was adding a psychosocial scale. Both long and short forms had very good psychometric properties.

Validity and reliability of the Foot Function Index (FFI) questionnaire Brazilian-Portuguese version.

PURPOSE: To evaluate the validity and reliability of the Foot Function Index (FFI) in its Brazilian Portuguese version. METHODS: The validity and reliability of the FFI were tested in 50 volunteers, with plantar fasciitis, metatarsalgia and chronic ankle sprain. The FFI validity process used the Short Form-36 (SF-36) and Foot and Ankle Outcome Score (FAOS) questionnaires. The correlation between FFI, SF-36 and FAOS was done using the Pearson's linear coefficient. The inter and intra-evaluator reliability was ascertained by means of the intraclass correlation coefficient (ICC) and the internal consistency by means of Cronbach's alpha coefficient. The scores were used to assess the standard error measurement (SEM), minimal detectable change (MDC) and ceiling floor and effects. RESULTS: The validity process showed that there were correlations between FFI and the "pain" and "social aspects" subscales of SF-36 and all subscales of FAOS, except for "other symptoms". The Brazilian-Portuguese version of FFI showed excellent intra and interevaluator correlations, with an ICC range of 0.99-0.97 and score reliability that was considered highly satisfactory, with Cronbach's alpha range of 0.80-0.61. The SEMs for inter and intra-evaluator reliability were 1.32 and 1.08, respectively. The MDC was 2.42 (90 % confidence interval). No ceiling and floor effect were detected. CONCLUSIONS: The Brazilian-Portuguese version of the FFI questionnaire was found to be a valid and reliable instrument for foot function evaluation, and can be used both in scientific settings and in clinical practice.

Systolic blood pressure variability and lower extremity amputation in a non-elderly population with diabetes.

OBJECTIVE: Systolic blood pressure (SBP) variability is emerging as a new risk factor for cardiovascular diseases, diabetic nephropathy, and other atherosclerotic conditions. Our objective is to examine whether it has any prognostic value for lower-extremity amputations. RESEARCH DESIGN AND METHODS: This is a nested case-control study of a cohort of patients with diabetes aged<60 years and treated in the US Department of Veterans Healthcare system in 2003. They were followed over five years for any above-ankle (major) amputations. For each case with a major amputation (event), we randomly selected up to five matched controls based on age, sex, race/ethnicity, and calendar time. SBP variability was computed using three or more blood pressure measures taken during the one-year period before the event. Patients were classified into quartiles according to their SBP variability. RESULTS: The study sample included 1038 cases and 2932 controls. Compared to Quartile 1 (lowest variability), Quartile 2 had 1.4 times (OR=1.44, 95% CI=1.00-2.07) and Quartiles 3 and 4 (highest) had 2.5 times (OR for Quartile 3=2.62, 95% CI=1.85-3.72; OR for Quartile 4=2.50, 95% CI=1.74-3.59) higher risk of major amputation (P for trend<0.001). This gradient relationship held in both normotensive and hypertensive groups as well as for individuals without prior peripheral vascular disease. CONCLUSIONS: This is the first study to show a significant graded relationship between SBP variability and risk of major amputation among non-elderly persons with diabetes.

Translation and cross-cultural adaptation of FFI to Brazilian Portuguese version: FFI - Brazil.

OBJECTIVE: Perform the translation and cultural adaptation of the questionnaire Foot Functional Index (FFI), which assesses the functionality of the foot, to the Brazilian Portuguese version. METHOD: The Brazilian version development of FFI questionnaire was based on the guideline proposed by Guillemin. The applied process consisted of: (1) translation; (2) back-translation; (3) committee review; (4) pretesting. The Portuguese version was applied to 40 patients, both genders, aged over 18 years old, with plantar fasciitis and metatarsalgia to verify the level of the instrument comprehension. The final Brazilian version of the FFI was set after getting less than 15% of "not understanding" on each item. RESULTS: Some terms and expressions were changed to obtain cultural equivalence for FFI. The terms that were incomprehensible were changed in accordance of patient suggestions. CONCLUSION: After the translation and cultural adaptation of the questionnaire, the final Portuguese version of FFI was concluded.

Geographic Variation in Rosiglitazone Use Surrounding FDA Warnings in the Department of Veterans Affairs.

BACKGROUND: Geographic variation in the use of prescription drugs, particularly those deemed harmful by the FDA, may lead to variation in patient exposure to adverse drug events. One such drug is the glucose-lowering drug rosiglitazone, for which the FDA issued a safety alert on May 21, 2007, following the publication of a meta-analysis that suggested a 43% increase in the risk of myocardial infarction with the use of rosiglitazone. This alert was followed by a black box warning on August 14, 2007, that was updated 3 months later. While large declines have been documented in rosiglitazone use in clinical practice, little is known about how the use of rosiglitazone and other glucose-lowering drugs varied within the Department of Veterans Affairs (VA), surrounding the FDA alerts. Understanding this variation within integrated health care systems is essential to formulating policies that enhance patient protection and quality of care. OBJECTIVE: To document variation in the use of rosiglitazone and other glucose- lowering drugs across 21 Veterans Integrated Service Networks (VISNs). METHODS: We conducted a retrospective analysis of drug use patterns for all major diabetes drugs in a national cohort of 550,550 veterans with diabetes from 2003 to 2008. This included the time periods when rosiglitazone was added to (November 2003) and removed from (October 2007) the VA national formulary (VANF). We employed multivariable logistic regression models to statistically estimate the association between a patient's location and the patient's odds of using rosiglitazone. RESULTS: Aggregate rosiglitazone use increased monotonically from 7.7%, in the quarter it was added to the VANF (November 4, 2003), to a peak of 15.3% in the quarter when the FDA issued the safety alert. Rosiglitazone use decreased sharply afterwards, reaching 3.4% by the end of the study period (September 30, 2008). The use of pioglitazone, another glucose-lowering drug in the same class as rosiglitazone, was low when the FDA issued the safety alert (0.4%) but increased sharply afterwards, reaching 3.6% by the end of the study period. Insulin use increased monotonically; metformin use remained relatively flat; and sulfonylurea use exhibited a general declining trend throughout the study period. Statistically significant geographic variation was observed in rosiglitazone use throughout the study period. The prevalence range, defined as the range of minimum to maximum use across VISNs was 3.7%-12.4% in the first quarter (January 1 to March 31, 2003); 1.0%-5.5% in the last quarter of study period (July 1 to September 30, 2008); and reached a peak of 9.6%-25.5% in the quarter when the FDA safety alert was issued (April 1 to March 31, 2007). In 5 VISNs, peak rosiglitazone use occurred before the FDA issued the safety alert. The odds ratio of using rosiglitazone in a given VISN varied from 0.55 (95% CI = 0.52-0.59; VISN 10) to 1.58 (95% CI = 1.50-1.66; VISN 15), with VISN 1 being the reference region. The variation was higher in the periods after the FDA issued the safety alert. Much less variation was observed in the use of pioglitazone, metformin, sulfonylurea, and insulin. CONCLUSIONS: Our results show statistically significant variation in the way VISNs within the VA responded to the FDA alerts, suggesting a need for mechanisms that disseminate information and guidelines for drug use in a consistent and reliable manner. Further study of regions that adopted ideal practices earlier may provide lessons for regional leadership and practice culture within integrated health care systems.

A review of the foot function index and the foot function index - revised.

BACKGROUND: The Foot Function Index (FFI) is a self-report, foot-specific instrument measuring pain and disability and has been widely used to measure foot health for over twenty years. A revised FFI (FFI-R) was developed in response to criticism of the FFI. The purpose of this review was to assess the uses of FFI and FFI-R as were reported in medical and surgical literature and address the suggestions found in the literature to improve the metrics of FFI-R. METHODS: A systematic literature search of PubMed/Medline and Embase databases from October 1991 through December 2010 comprised the main sources of literature. To enrich the bibliography, the search was extended to BioMedLib and Scopus search engines and manual search methods. Search terms included FFI, FFI scores, FFI-R. Requirements included abstracts/full length articles, English-language publications, and articles containing the term "foot complaints/problems." Articles selected were scrutinized; EBM abstracted data from literature and collected into tables designed for this review. EBM analyzed tables, KJC, JM, RMS reviewed and confirmed table contents. KJC and JM reanalyzed the original database of FFI-R to improve metrics. RESULTS: Seventy-eight articles qualified for this review, abstracts were compiled into 12 tables. FFI and FFI-R were used in studies of foot and ankle disorders in 4700 people worldwide. FFI Full scale or the Subscales and FFI-R were used as outcome measures in various studies; new instruments were developed based on FFI subscales. FFI Full scale was adapted/translated into other cultures. FFI and FFI-R psychometric properties are reported in this review. Reanalysis of FFI-R subscales' confirmed unidimensionality, and the FFI-R questionnaires' response categories were edited into four responses for ease of use. CONCLUSION: This review was limited to articles published in English in the past twenty years. FFI is used extensively worldwide; this instrument pioneered a quantifiable measure of foot health, and thus has shifted the paradigm of outcome measure to subjective, patient-centered, valid, reliable and responsive hard data endpoints. Edited FFI-R into four response categories will enhance its user friendliness for measuring foot health.

Obesity paradox in amputation risk among nonelderly diabetic men.

The association between BMI and amputation risk is not currently well known. We used data for a cohort of diabetic patients treated in the US Department of Veterans Affairs Healthcare System in 2003. Men aged <65 years at the end of follow-up were examined for their amputation risk and amputation-free survival during the next 5 years (2004-2008). Compared to overweight individuals (BMI 25-29.9 kg/m(2)), the risks of amputation and treatment failure (amputation or death) were higher for patients with BMI <25 kg/m(2) and were lower for those with BMI ≥30 kg/m(2). Individuals with BMI ≥40 kg/m(2) were only half as likely to experience any (hazard ratios (HR) = 0.49; 95% confidence interval (CI), 0.30-0.80) and major amputations (HR = 0.53; 95% CI, 0.39-0.73) during follow-up as overweight individuals. While the amputation risk continued to decrease for higher BMI, amputation-free survival showed a slight upturn at BMI >40 kg/m(2). The association between obesity and amputation risk in our data shows a pattern consistent with "obesity paradox" observed in many health conditions. More research is needed to better understand pathophysiological mechanisms that may explain the paradoxical association between obesity and lower-extremity amputation (LEA) risk.

Translation and cultural adaptation of the revised foot function index for the Portuguese language: FFI-R Brazil

ABSTRACT BACKGROUND: The revised foot function index (FFI-R) is used to evaluate the functionality of patients with conditions that affect the feet. The objective here was to produce the Brazilian Portuguese version of this index. DESIGN AND SETTING: Translation and validation study conducted at the Federal University of São Paulo, Brazil. METHODS: The translation and cultural adaptation process involved translation by two independent translators, analysis by an expert committee, back translation into the original language, analysis by the expert committee again and a pretest. The Portuguese-language version was administered to 35 individuals with plantar fasciitis and metatarsalgia to determine their level of understanding of the assessment tool. RESULTS: Changes were made to the terms and expressions of some original items to achieve cultural equivalence. Terms not understood by more than 10% of the sample were altered based on the suggestions of the patients themselves. CONCLUSION: The translation and cultural adaptation of the FFI-R for the Portuguese language were completed and the Brazilian version was obtained.

Lower-extremity amputation risk after charcot arthropathy and diabetic foot ulcer.

OBJECTIVE: To compare risks of lower-extremity amputation between patients with Charcot arthropathy and those with diabetic foot ulcers. RESEARCH DESIGN AND METHODS: A retrospective cohort of patients with incident Charcot arthropathy or diabetic foot ulcers in 2003 was followed for 5 years for any major and minor amputations in the lower extremities. RESULTS: After a mean follow-up of 37 +/- 20 and 43 +/- 18 months, the Charcot and ulcer groups had 4.1 and 4.7 amputations per 100 person-years, respectively. Among patients <65 years old at the end of follow-up, amputation risk relative to patients with Charcot alone was 7 times higher for patients with ulcer alone and 12 times higher for patients with Charcot and ulcer. CONCLUSIONS: Charcot arthropathy by itself does not pose a serious amputation risk, but ulcer complication multiplicatively increases the risk. Early surgical intervention for Charcot patients in the absence of deformity or ulceration may not be advisable.

Predictors of weight loss in overweight veterans with knee osteoarthritis who participated in a clinical trial.

Individuals with osteoarthritis (OA) of the knee have a high prevalence of obesity. The objective of this study was to determine predictors of weight loss among participants with knee OA in a clinical trial. A secondary analysis of data from a randomized clinical trial was used. Multiple regression analysis was used to predict weight loss after identification of predictor variables from the data. Hypothesized predictors of weight loss included demographic, clinical, and behavioral characteristics. The only baseline variable that was significantly related to weight loss was the Center for Epidemiologic Studies Depression Scale (CES-D) score. The CES-D score was an independent predictor of weight loss at 16 (p < 0.01) and 32 weeks (p < 0.05). Receiving nutrition counseling was also predictive of weight loss at 16 weeks (p < 0.03). These two variables explained 24% and 22% of the variance in weight loss for weeks 16 and 32, respectively. Being less depressed and receiving nutritional counseling appeared predictive of weight loss in this group of veterans.

Diagnostic accuracy of existing methods for identifying diabetic foot ulcers from inpatient and outpatient datasets.

BACKGROUND: As the number of persons with diabetes is projected to double in the next 25 years in the US, an accurate method of identifying diabetic foot ulcers in population-based data sources are ever more important for disease surveillance and public health purposes. The objectives of this study are to evaluate the accuracy of existing methods and to propose a new method. METHODS: Four existing methods were used to identify all patients diagnosed with a foot ulcer in a Department of Veterans Affairs (VA) hospital from the inpatient and outpatient datasets for 2003. Their electronic medical records were reviewed to verify whether the medical records positively indicate presence of a diabetic foot ulcer in diagnoses, medical assessments, or consults. For each method, five measures of accuracy and agreement were evaluated using data from medical records as the gold standard. RESULTS: Our medical record reviews show that all methods had sensitivity > 92% but their specificity varied substantially between 74% and 91%. A method used in Harrington et al. (2004) was the most accurate with 94% sensitivity and 91% specificity and produced an annual prevalence of 3.3% among VA users with diabetes nationwide. A new and simpler method consisting of two codes (707.1× and 707.9) shows an equally good accuracy with 93% sensitivity and 91% specificity and 3.1% prevalence. CONCLUSIONS: Our results indicate that the Harrington and New methods are highly comparable and accurate. We recommend the Harrington method for its accuracy and the New method for its simplicity and comparable accuracy.