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Biomedical subjects

Judith G Regensteiner

Publications and source records attributed to Judith G Regensteiner.

10 recordsLinked to original sources

Functional outcome in a contemporary series of major lower extremity amputations.

PURPOSE: We undertook this study to document the functional natural history of patients undergoing major amputation in an academic vascular surgery and rehabilitation medicine practice. METHODS: A retrospective review was conducted of consecutive patients undergoing major lower extremity amputation and rehabilitation in a university and Department of Veterans Affairs hospital. Main outcome variables included operative mortality, follow-up, survival, median time to incision healing, secondary operative procedures for wound management, and conversion from below-knee amputation (BKA) to above-knee amputation (AKA). For surviving patients, quality of life was determined by degree of ambulation, eg, outdoors, indoors only, or no ambulation; use of a prosthesis; and independence, eg, community housing or nursing facility. RESULTS: From August 1997 through March 2002, 154 patients (130 men; median age, 62 years) underwent 172 major amputations, 78 AKA and 94 BKA, because of either critical limb ischemia (87%) or diabetic neuropathy (13%). Thirty-day operative mortality was 10%. Mean follow-up was 14 months. Healing at 100 and 200 days, as determined with the Kaplan-Meier method, was 55% and 83%, respectively, for BKA, and 76% and 85%, respectively, for AKA. Twenty-three BKA and 16 AKA required additional operative revision, and 18 BKA ultimately were converted to AKA. Survival was 78% at 1 year and 55% at 3 years. Function in surviving patients at 10 and 17 months, respectively, was as follows: 21% and 29% of patients ambulated outdoors, 28% and 25% ambulated indoors only, and 51% and 46% of patients were nonambulatory; 32% and 42% of patients used prosthetic limbs; and 17% and 8% of patients who lived in the community before amputation required care in a nursing facility. CONCLUSIONS: We were surprised to find that vascular patients in a contemporary setting who require major lower extremity amputation and rehabilitation often remain independent despite infrequent prosthesis use and outdoor ambulation. Although any hope for postoperative ambulation in this population requires salvaging the knee joint, because of the morbidity incurred in both wound healing and rehabilitation efforts, aggressive effort should be reserved for selected patients at good risk. Ability to predict ambulation after BKA in the vascular population is poor.

Activities of Daily Living↗

Evaluating effects of method of administration on Walking Impairment Questionnaire.

BACKGROUND: Intermittent claudication resulting from peripheral arterial disease (PAD) can substantially impair walking function. The Walking Impairment Questionnaire (WIQ) assesses patient self-reported difficulty in walking. Currently this questionnaire is validated for interviewer administration only. Since this can be burdensome in a large clinical trial, we examined the effects of alternative methods of administration on patient responses on the WIQ. METHODS: The WIQ, which consists of four subscales (pain severity, distance, speed, stairs), was modified to be self-administered or interviewer-administered by telephone. Patients with PAD were recruited from two sites and randomized into two groups: in group 1 the WIQ was self-administered, then telephone-administered; in group 2 the WIQ was telephone-administered, then self-administered. The two administrations occurred 4 to 7 days apart. Additional measures (SF-36, EQ-5D, and PAD symptom scale) and clinical data were included to further assess the validity of the WIQ and symptoms in patients with claudication. Telephone interviews were conducted by trained interviewers using standardized scripts. Two-week test-retest reliability was assessed for both the self-administered WIQ (group 1) and the telephone-administered WIQ (group 2). RESULTS: Sixty patients were recruited at two sites (n = 30 per group). Seventy-eight percent were men; mean patient age was 67.1 years; and 83% of patients were white. Mean duration of PAD symptoms was 6.8 years. No significant differences were observed in WIQ subscale scores between self administration and telephone administration. No interaction effects between order and method of administration were detected. Cronbach alpha for distance, speed, and stair-climbing subscales ranged from 0.82 to 0.94. Correlations among WIQ subscales and the symptom scale were good (r = -0.34 to -0.57). Correlations of WIQ subscales with physical health subscales of the SF-36 (r = 0.24-0.59) were higher than for mental health-related subscales (r = 0.08-0.26). CONCLUSIONS: The modified WIQ demonstrated good reliability and validity with both methods of administration. These results suggest that the self-administered and telephone-administered versions of the WIQ can be used reliably and efficiently in clinical trials.

Aged↗

Current medical therapies for patients with peripheral arterial disease: a critical review.

There is a paucity of trials that specifically evaluate the benefits of cardiovascular risk reduction therapies in patients with peripheral arterial disease. We therefore sought to describe the data supporting the use of therapies for lowering cardiovascular risk, preventing ischemic events, as well as managing intermittent claudication, in these patients. A search for randomized, placebo-controlled trials in peripheral arterial disease was conducted using Medline and reference lists of relevant articles. These trials served as the primary sources of data and treatment recommendations, while observational studies and case series were included as sources of commonly accepted treatment recommendations that were not fully supported by the randomized trial. Data from the primary sources support the use of antiplatelet therapy and, potentially, of angiotensin-converting enzyme inhibitors, for preventing ischemic events. In contrast, the evidence demonstrates a nonsignificant trend for treating dyslipidemia to prevent mortality and does not specifically support intensive glycemic control in persons with diabetes or estrogen use in these patients. However, observational data and data derived from trials in persons with other manifestations of cardiovascular disease may be generalized to support the importance of treating key risk factors, such as smoking, diabetes, dyslipidemia, and hypertension. Data supporting the use of estrogen to reduce cardiovascular risk are less clear. Studies do demonstrate improvement in walking ability resulting from exercise rehabilitation programs, as well as from use of cilostazol and, to a more modest degree, pentoxifylline. The consensus is to treat risk factors of peripheral arterial disease patients similarly to patients with other manifestations of atherosclerosis and to use exercise rehabilitation or cilostazol to treat the subset of patients with claudication.

Angiotensin-Converting Enzyme Inhibitors↗

Treatment of peripheral arterial disease.

Peripheral arterial disease (PAD) is a manifestation of systemic atherosclerosis strongly associated with cardiovascular (CV) morbidity and mortality. Approximately 12% of the US adult population is affected. Despite its prevalence, the disease has received little attention from clinicians. The primary causes of death in patients with PAD are myocardial infarction and stroke; thus, current treatment strategies for symptomatic PAD include aggressive modification of risk factors for CV disease such as cessation of smoking, treatment of hypertension and diabetes, and normalization of low-density lipoprotein cholesterol levels. All patients with PAD should be receiving antiplatelet therapy to prevent ischemic events. Medical treatment for patients with claudication includes exercise rehabilitation and drug therapy. Although many therapies for claudication have been thoroughly investigated, research continues on new treatments. In contrast, more prospective, randomized trials are needed to evaluate various therapies for treating patients with PAD.

Arteriosclerosis↗

Effect of cilostazol on treadmill walking, community-based walking ability, and health-related quality of life in patients with intermittent claudication due to peripheral arterial disease: meta-analysis of six randomized controlled trials.

OBJECTIVES: To assess whether cilostazol, a phosphodiesterase III inhibitor, improves treadmill and community-based walking ability and health-related quality of life (HQL) in patients with intermittent claudication resulting from peripheral arterial disease (PAD). DESIGN: Retrospective meta-analysis of data pooled from six Phase 3, multicenter, double-blind, placebo-controlled, parallel-group, randomized studies. SETTING: Patients were recruited from outpatient ambulatory medical care facilities. PARTICIPANTS: Patients' (n = 1,751) mean age +/- standard deviation was 65 +/- 9, and they had a history of PAD for 6 months or longer and an ankle brachial index (ABI) of 0.90 or less. INTERVENTION: Cilostazol 50 mg bid or 100 mg bid for 12, 16, or 24 weeks. MEASUREMENTS: ABI; maximal walking distance (MWD); pain-free walking distance on a graded and constant-load treadmill; and HQL, measured using the Walking Impairment Questionnaire (WIQ) and the Medical Outcomes Study Short Form-36 (SF-36). RESULTS: Maximal treadmill walking distance improved more in both cilostazol groups than in the placebo group (both P <.0001). WIQ and SF-36 physical summary scores improved significantly more with cilostazol than with placebo (for instance, WIQ distance score, P <.0001 and SF-36 physical summary score, P <.0001, comparing persons taking cilostazol with controls). Improved MWD correlated with improvements in WIQ (correlation with distance score, r = 0.34, P <.0001) and SF-36 physical summary scores (r = 0.29, P <.0001). CONCLUSIONS: Treatment with cilostazol was associated with greater improvements in community-based walking ability and HQL in patients with intermittent claudication than treatment with placebo. These improvements correlated with increased MWD. This analysis of effects of cilostazol on improving walking ability in persons with claudication is the first cilostazol study focused on community-based measures of functional status and HQL. Questionnaires assessing walking ability and HQL provide important patient-based information about clinical outcomes of claudication therapy.

Aged↗

Why do some women refuse to allow male residents to perform pelvic exams?

PURPOSE: Many women who receive medical care in residency training clinics refuse to allow male residents to perform their pelvic exams. This study was conducted to identify which women were most likely to refuse and to learn their reasons for refusing. METHOD: From January to March 1997, a questionnaire was given to all women entering a Tri-County Health office and a Planned Parenthood clinic, both in the Denver, Colorado, metropolitan area, who consented to participate in the study. Data from the questionnaire were analyzed using a statistical software package. RESULTS: A total of 1,437 women entered the clinics during the study period. Of these patients, 1,078 consented to complete the questionnaire. Seven of these 1,078 women did not complete the questionnaire. Women who did not know the training level of the resident performing the pelvic exam were more likely to refuse than were women who knew the training level of the resident (p =.001), but many women preferred a female physician regardless of the physician's training level. Fifty-eight percent said they would allow a male resident to observe a female attending physician perform the exam, compared with 36% who said they would allow a male resident to observe if the attending physician was a man. Common statements from those who would refuse were: "I am just more comfortable with a female," "Women do not want men to examine their private body parts," and "Women explain things better." CONCLUSIONS: A woman's knowledge of the resident's training level correlates with her willingness to have a pelvic exam performed by a male resident. Women who said they would refuse a pelvic exam performed by a male resident gave specific reasons for their decision.

Adult↗

A patient-derived perspective of health-related quality of life with peripheral arterial disease.

PURPOSE: To evaluate the effects of peripheral artery disease (PAD) on health-related quality of life (HRQoL) from the patient's perspective to establish a foundation for systematic PAD-specific HRQoL assessment in this population. DESIGN: Grounded theory methodology. METHODS: Open-ended, tape-recorded interviews were conducted with 38 patients (24 men, 14 women) 44 to 83 years old (mean 65) from two US medical centers to report patient experience of PAD and its perceived effects on HRQoL. Tapes were transcribed and analyzed to identify themes and conceptual domains pertinent to the experience of PAD in this population. RESULTS: Seven major themes were identified: (a) delay in diagnosis and frustration with management of disease; (b) pain; (c) limitation in physical functioning; (d) limitation in social and role functioning; (e) compromise of self; (f) uncertainty and fear; and (g) adaptation to the effects of the disease and demonstration of resiliency. CONCLUSIONS: These findings indicate important psychosocial and emotional consequences of PAD that existing HRQoL questionnaires do not indicate. More complete data might lead to greater understanding of the effects of PAD, serving as the foundation for a more sensitive instrument to assess HRQoL as a basis for more effective interventions.

Adult↗

Impaired fibrinolysis in premenopausal women and age-matched men with Type 2 diabetes mellitus: a pilot study.

BACKGROUND: The presence of Type 2 diabetes mellitus (DM) is one of the strongest predictors of cardiovascular disease (CVD) in women. Although the specific mechanisms underlying this increased risk are unknown, one factor that may contribute to CVD in women with Type 2 DM is impaired fibrinolysis. Healthy premenopausal women have a low rate of CVD and excellent fibrinolytic potential. Impairment in fibrinolysis in people with DM has been demonstrated mainly in men, whereas the fibrinolytic potential of women with Type 2 DM has not been characterized well. This pilot study compared fibrinolytic measures in premenopausal women and men with DM with those of healthy age-matched control women and men to help determine whether fibrinolysis is abnormal in women with DM. METHODS: Fibrinolytic measurements included euglobulin clot lysis time (ELT), fibrinogen, plasminogen activator inhibitor 1, and tissue-type plasminogen activator. RESULTS: Poststasis ELT was significantly impaired in the women with DM as compared with the control women. The men with DM had a tendency toward slower poststasis ELT than did the control men, but the differences between the men's groups were not significant. In the women's groups only, we observed a trend toward increased plasminogen activator inhibitor 1 among the women with DM. CONCLUSIONS: Women with DM have a more significant abnormality in poststasis ELT than do men with DM as compared with sex-specific counterparts without DM.

Adult↗