Use of FT-NIR transmission spectroscopy for the quantitative analysis of an active ingredient in a translucent pharmaceutical topical gel formulation.

The objective of this study was to demonstrate the use of transmission Fourier transform near-infrared (FT-NIR) spectroscopy for quantitative analysis of an active ingredient in a translucent gel formulation. Gels were prepared using Carbopol 980 with 0%, 1%, 2%, 4%, 6%, and 8% ketoprofen and analyzed with an FT-NIR spectrophotometer operated in the transmission mode. The correlation coefficient of the calibration was 0.9996, and the root mean squared error of calibration was 0.0775%. The percent relative standard deviation for multiple measurements was 0.10%. The results prove that FT-NIR can be a good alternative to other, more time-consuming means of analysis for these types of formulations.

Psychosocial versus nicotine-only self-report measures for predicting follow-up smoking status.

The most popular measure of tobacco dependence, the Fagerstrom Tolerance Questionnaire (FTQ), measures only tobacco-specific behaviors. In contrast, the most popular assessment of addiction among polydrug users is the Addiction Severity Index (ASI). Most of the subscales comprising the ASI are psychosocial measures, not drug-specific measures. A study was undertaken to compare the predictive utility of these two contrasting measures. The NAS (adapted from the FTQ) and the Addiction Severity Index (ASI) were used to predict future smoking status in a cohort of polydrug users followed annually for 3 years. The baseline NAS score explained more of the variance in Time 2 and Time 3 smoking status than did the ASI subscales. When previous smoking status was included as a covariate, however, the NAS no longer predicted future smoking status, whereas the ASI Subscales continued to explain significant variance in future smoking status. Results suggest that when past smoking behavior is known, a respondent's legal status and alcohol use may be more useful than a measure of tobacco dependence for predicting future smoking status.

Differential response to targeted recruitment strategies to fitness promotion research by African-American women of varying body mass index.

OBJECTIVE: To assess patterns of recruitment into a community-based NCI-funded physical activity and dietary lifestyle change program targeting African-American women. DESIGN: Acquisition of a convenience sample to be screened for participation in a randomized, controlled prevention intervention. SETTING: African-American-owned and -operated health club located in an area of Los Angeles in which African Americans are concentrated. PARTICIPANTS: 893 African-American women. RECRUITMENT STRATEGIES: Social networking/word-of-mouth, staff presentations, mass and targeted media, and physician referral. MAIN OUTCOME MEASURE: Completion of screening questionnaire indicating a desire to enroll in the study. Screening questionnaire domains included self-reported height and weight, recent participation in organized weight loss programs, ability to walk one mile unassisted, current medication use, smoking status, personal medical history of cancer, sociodemographic variables, and recruitment source. RESULTS: Sociodemographic and anthropometric characteristics distinguished between respondents obtained through different recruitment strategies. In particular, women with a higher body mass index (BMI) were more likely than those with lower BMIs (P = .014) to be recruited through more personalized methods (eg, social networking). CONCLUSIONS: Culturally tailored recruitment strategies are critical in securing the participation of members of "hard-to-reach" populations, who are both under-represented in health promotion research and at high risk for chronic diseases.

Individual change amid stable smoking patterns in polydrug users over 3 years.

The pattern of stability/change in smoking status was examined annually in 254 community-dwelling polydrug users over 3 years. Respondents' smoking status was classified as nonsmoker, intermittent smoker, or "everyday" smoker. Results showed that the typical probability of retaining the same smoking status across any two consecutive assessments was: 0.77 for nonsmokers (never smokers and former smokers combined), 0.82 for everyday smokers, and 0.16 for intermittent smokers. The transition matrix proved stable across three observations; the predicted equilibrium distribution matched well with observed distributions. Fifty-five percent of intermittent smokers converted to everyday smoking within a year, but 29% converted to former-smoker status in the same period. No other transition exceeded 12%. Considerable flux in individual smoking status, particularly among intermittent smokers, was observed despite stable prevalence of smoking status in this population. Intermittent smoking status appeared to be a temporary "way station" between the two more stable everyday smoker and nonsmoker classifications. Results challenge current assumptions about "occasional" or "chipper" smokers.

Overweight and depressive symptoms among African-American women.

BACKGROUND: In a national survey, a correlation between overweight and depression was explained by dieting and poor health. This study examines overweight and depressive symptoms among urban African-American women, taking into account demographic factors, health status and practices, and psychosocial constructs. METHODS: Respondents are 429 participants in a pilot for a culturally tailored intervention promoting healthful eating and exercising. Anthropomorphic and self-administered questionnaire data were collected at a community health club site. RESULTS: Controlling for demographic factors, overweight is associated with symptoms of depression, a relationship that is partially explained by health status, but not by dietary restraint. Using multiple regression, poor health status, alcohol intake, hostility, and low levels of ethnic identity (connectedness with the African-American community) are independent predictors of depressed mood. In this study, dietary restraint reflects healthful eating and is inversely related to depression. The overweight/depression association is stronger among women with high levels of education and high levels of ethnic identity (statistical interactions). CONCLUSION: Poor health likely contributes over time to both overweight and depressed mood. Ethnic identity enhancement strategies should be studied for their effectiveness in strengthening identity and for their potential in attracting individuals especially likely to benefit from lifestyle change programs.

Measures of success and health-related quality of life in lower-extremity vascular surgery.

Lower-extremity vascular surgery is most often indicated for patients with critical leg ischemia but has increasingly been used for patients with disabling intermittent claudication. This article reviews indications, follow-up protocols, and procedure-related outcomes including perioperative and late mortality, complications, and long-term patency rates, which vary with patient risk factors, vascular disease severity, and hospital volume. Population-based studies have yet to establish whether rates of limb-preserving bypass surgery are related to overall amputation rates, partly because of the continued high rate of primary amputation. The functional benefits of vascular surgery have been traditionally assessed by treadmill protocols and batteries of physical tests. Claudication treatment is increasingly being measured by both generic and disease-specific functional and health-related quality-of-life questionnaires. Patient self-reported measures of physical functioning and walking ability are reviewed. Finally, conclusions are presented about trends in lower-extremity bypass surgery rates.

Functional status and walking ability after lower extremity bypass grafting or angioplasty for intermittent claudication: results from a prospective outcomes study.

OBJECTIVE: The purpose of this study was the prospective comparison of functional outcomes after lower extremity bypass grafting surgery, angioplasty, or medical management of intermittent claudication. METHODS: The study was designed as a prospective cohort study to compare functional outcomes for patients with interventional management to medical management, including a matched (younger, with more disability) subgroup, followed for a mean of 19 months. Sixteen Chicago-area vascular surgery clinics participated in the study. The subjects were consecutively enrolled patients with an abnormal ankle-brachial blood pressure index (ABI), without signs of rest pain, ulcer, or gangrene, and without prior lower extremity revascularization procedures. The main outcome measures were changes in physical functioning, community walking distance, bodily pain, leg symptoms, and ABI. RESULTS: Of the 526 study patients, 20% underwent revascularization procedures (60 surgical bypass grafting and 44 angioplasty only). The mean ABI improved significantly for the patients who underwent bypass grafting surgery (0.20; P <.001) and modestly for the patients who underwent angioplasty (0.09; P <. 05). Patients undergoing bypass grafting and angioplasty maintained highly significant (P <.001) improvements in mean physical functioning, (17%, 14%), bodily pain (18%, 13%), and walking distance (28%, 27%) scores and reported greater leg symptom improvement. The results were far superior for the patients with greater improvement in ABI. The conditions of the 277 unmatched patients who underwent medical management declined on all outcome measures, and the conditions of the 145 matched patients who underwent medical management improved 5% (P <.001) on walking distance score. Eighteen percent of the study patients failed to complete the full study follow-up period. CONCLUSION: Most of the functional improvement achieved by patients who underwent interventional management appears to be related to improved patency rather than to selection bias or placebo effects. The functional gains were approximately half those often reported for patients for hip arthroplasty and similar to patients who undergo elective coronary angioplasty.

Comparing three preprocessing strategies for longitudinal data. An example in functional outcomes research.

Longitudinal monitoring of individual patient data is becoming routine in physician office practice. This study compares three different methods for evaluating clinical outcomes for individual patients: raw change score analysis versus normative and ipsative statistical analyses. Two discrete samples of intermittent claudication patients making vascular surgery office visits--drawn from interventional management versus stable, routinely followed control groups--were tested four times using both generic and disease-specific functional status measures. Results indicated that the ipsative method was most consistent with several different types of a priori hypotheses that are often evaluated in analysis of repeated measures data.

Reoperative aortic surgery.

The presentation of long-term complications after conventional aortic surgery and the treatment of patients that have had reoperative aortic operations are reviewed. Ninety-seven consecutive patients that had 102 subsequent aortic operations at a tertiary referral center were studied. Presenting symptoms, demographics, risk factors, indications for initial and second procedures, operative techniques and outcomes were recorded in a computerized database. There were 70 men and 27 women studied, with an average age of 64 years. First operations were performed primarily for aneurysm (56%) and occlusive disease (44%). The interval between procedures ranged up to 23 years, with a mean of 6 years. Indications for reoperation were subsequent aneurysm (65), graft occlusions (25) and/or infections (24). Seventy-three percent of the subsequent aneurysms were true metachronous aneurysms; the others were associated with the graft or an anastomosis. Para-anastomotic aneurysms may be more common with a primary end-to-side graft configuration. One-third of subsequent aneurysms were not palpable and asymptomatic. Graft occlusion can be treated safely with elective repeat bypass (mortality 0%). Graft infections that require total graft removal remain a challenging problem (mortality 17%). Although surgical approach for reoperations utilized more extensive exposure and proximal clamping, 59 elective aneurysm cases had a 5.1% mortality rate; eight emergent procedures for ruptured aneurysms resulted in 88% mortality. Reoperation for graft occlusion or infection showed a similar high mortality rate with emergent cases. In this referral practice, graft occlusion and infection are relatively less frequent, whereas metachronous aneurysm formation is now the most common indication for reoperation. These aneurysms often remain undetected until symptoms occur; frank rupture is usually lethal. As elective repair with modern reoperative techniques can be safely performed, routine computed tomographic examination is advisable at least every 5 years after aortic operations.

Natural history of composite sequential bypass: ten years' experience.

BACKGROUND: We previously reported 48-month patency rates of composite sequential bypass (CSB) approaching 60%. Yet, extended patency and limb salvage rates are unknown. HYPOTHESIS: Long-term patency and limb salvage rates of CSB are affected by sex, bypass configuration, and warfarin therapy. DESIGN: Medical records of all patients who underwent CSB during a 10-year period were retrospectively reviewed. SETTING: A referral center for the Chicago, Ill, region. PATIENTS: One hundred consecutive patients (mean age, 68.8 years; 57% were men and 49% had diabetes) undergoing 102 CSBs for limb salvage (ulcer, 43%; rest pain, 39%; and gangrene, 18%) from January 1986 to January 1996 were identified. INTERVENTIONS: Warfarin was used after surgery by 72% of patients and aspirin was used by the remainder of them. MAIN OUTCOME MEASURES: Life table primary patency and limb salvage rates were compared for sex, diabetes mellitus status, location of distal prosthetic anastomosis (above knee vs. below knee), and anticoagulation drug therapy (warfarin sodium vs aspirin) with log-rank statistics. RESULTS: Primary patency of CSB was 56% at 24 months, 29% at 48 months, and 20% at 84 months (SE <10%; mean follow-up, 19.6 months [range, 1.0-110.0 months]). Limb salvage rates were 64% at 24 months, 30% at 48 months, and 23% at 84 months (SE <10%); 66% and 90% of patients had failed grafts requiring amputation by 3 months and 1 year, respectively. CONCLUSIONS: Composite sequential bypass for limb salvage provides reasonable 2-year patency. However, patency rates steadily declined from year 2 to year 5. After CSB failure, limb salvage rates are poor, with 90% of patients progressing to amputation within 1 year.

Thoracoscopically-assisted thoraco-femoral bypass in a canine model.

Interest in minimally invasive procedures for vascular disease has grown tremendously over the past few years. Herein, we report our initial experience with a thoracoscopically-assisted thoraco-femoral bypass in a larger animal model. Included are various approaches to a final recommendation for the technique.

Minimally invasive thoracoscopic thoraco-femoral bypass: a case report.

Thoracoscopic techniques have improved a variety of thoracic surgical procedures. Thoraco-femoral bypass is an exceptional alternative to standard thoracoscopic thoraco-femoral bypass. Herein we report our initial human experience with a thoracoscopic thoraco-femoral bypass.

Combined arterial reconstruction and free tissue transfer for limb salvage.

PURPOSE: Lower-extremity arterial anatomy that is insufficient for successful vein bypass grafting and major proximal foot wounds often lead to leg amputation in patients with severe ischemia. Free tissue transfer, which can provide limb salvage in these patients after arterial reconstruction, was studied. METHODS: During a 45-month period, 21 patients who otherwise would have undergone leg amputation were treated with arterial bypass by means of vein grafting and free tissue transfer. Ages of the patients ranged from 40 to 73 years (average, 59 years); 18 of the 21 patients had diabetes mellitus; and all patients except one were men. Arterial reconstruction was performed from the femoral (nine of 21 patients) or popliteal artery (12 of 21 patients) to the posterior tibial (eight patients), dorsalis pedis (five patients), peroneal (three patients), popliteal (one patient), or anterior tibial artery (one patient), or directly to the free flap (three patients). The tissue transferred included latissimus dorsi (five patients), rectus abdominus (five patients), omentum (five patients), gracilis (two patients), radial forearm flaps (three patients), and a scapular flap (one patient). Foot defects were debrided, including the appropriate toe or transmetatarsal amputation, covered with the transferred flap, and then split-thickness skin grafted. Arterial flow for all flaps was through the vein grafts, with direct arterial anastomosis and with venous outflow through adjacent tibial veins. RESULTS: All 21 procedures were successful initially, without operative mortality, but three failed within 4 weeks because of uncontrolled infection (two) or embolization from a remote site (one) and required below-knee amputation. Grafts remained patent in 18 procedures, and follow-up of this cohort ranged from 1 to 45 months (mean, 13.3 months). Two patients died, one after 4 months and one after 6 months, of unrelated illness; at the time of death, they had functioning grafts. The remaining 19 patients are alive. Of these, 15 have patent arterial grafts, all viable free flaps. Thus, limb salvage was accomplished in 18 of 21 (86%) patients who otherwise would have required below-knee amputation. CONCLUSION: Patients destined for leg amputation despite aggressive traditional arterial bypass grafting methods can achieve limb salvage with the additional technique of free tissue transfer.

Mentholated cigarette smoking and lung-cancer risk.

PURPOSE: Menthol smoking may lead to a greater increase in lung-cancer risk than smoking of nonmentholated cigarettes. Mentholation of cigarettes adds additional carcinogenic components to cigarette smoke and increases retention times for cigarette smoke in the lungs. Only two epidemiologic studies have been conducted on menthol smoking and lung cancer, and their results are conflicting. Of note, African American males have much higher rates of lung cancer than Caucasian males despite smoking fewer cigarettes per day. Because the consumption of menthol cigarettes is much more frequent among African Americans, it is of interest to examine the possible association between menthol smoking and lung-cancer risk in this population. METHODS: We examined the association between menthol cigarette smoking and lung-cancer risk among smokers by comparing 337 incident cases of lung cancer with 478 population controls enrolled in a case-control study of lung cancer. Information on smoking history and other known and potential risk factors for lung cancer, including dietary intake, was obtained by in-person interviews. RESULTS: The adjusted odds ratios did not differ appreciably between smokers of mentholated cigarettes versus exclusive nonmentholated cigarette smokers in the overall study group of smokers. The odds ratio (OR) for 32 pack-years or more of mentholated vs. nonmentholated cigarettes was 0.90 (95% confidence interval (CI) = 0.38-2.12) in African Americans and 1.06 (95% CI = 0.47-2.36) in Caucasians, and did not differ for either ethnic group (p = 0.98). CONCLUSIONS: Our results suggest that the lung-cancer risk from smoking mentholated cigarettes resembles the risk from smoking non-mentholated cigarettes. Our data do not support the hypothesis that the increased risk of lung cancer among African Americans is due to the increased prevalence of menthol smoking.

Physical activity among African American and Latino middle school girls: consistent beliefs, expectations, and experiences across two sites.

Physical inactivity is a major public health concern. Low levels of physical activity are reported in many subgroups of women including adolescent girls. More data are needed to better understand factors related to physical activity participation in adolescent girls. Therefore, we explored adolescent girls' reasons for participating and not participating in physical activity. Two independent samples were taken in California and Texas; the total sample included thirty-four African American and Latino girls. Six focus groups were conducted by trained facilitators. Based on independent qualitative analyses, six replicated themes emerged from the focus groups. Fun, social support, and concern with body image facilitated participation in activity. In contrast, negative experiences in physical education classes, concerns about appearance after activity, and lack of opportunity impeded participation in activity. Overall, the girls showed an interest in physical activity and identified activity motivators and barriers. We discuss the implications of our findings for future research.

Carotid plaque morphology correlates with presenting symptomatology.

PURPOSE: In carotid artery disease, correlation of carotid plaque morphology with the patient's presenting symptoms has drawn conflicting conclusions. The purpose of this series was to correlate carotid plaque characteristics with the presenting symptoms from a large cohort of patients who underwent operation for carotid artery disease. METHODS: From a series of 1252 consecutive patients who underwent carotid endarterectomy, presenting symptoms were divided into three groups: transiently symptomatic (transient ischemic attack [TIA] or amaurosis fugax), prior stroke, and asymptomatic. Plaque characteristics, including ulceration, intraplaque hemorrhage, and degree of stenosis, were recorded prospectively for 1008 procedures. All endarterectomy specimens were inspected during the procedure, and plaque characteristics were recorded immediately after operation. RESULTS: There was a higher incidence of plaque ulceration in the transiently symptomatic and prior stroke groups (391 of 508 [77%] and 91 of 115 [79%]) than in the asymptomatic cohort (231 of 385 [60%]; p < 0.0001, chi2 test). There was no significant difference in the incidence of plaque hemorrhage between the transiently symptomatic and prior stroke patients compared with the asymptomatic patients. There was no statistical difference for ulcerated plaque or plaque hemorrhage between the transiently symptomatic and prior stroke group. Intraplaque hemorrhage occurred more frequently in patients with high-grade stenosis (90% to 99%) than in those with less than 90% stenosis (202 of 299 [68%] versus 97 of 299 [32%]; p = 0.01, chi2 test). CONCLUSIONS: On gross examination of the carotid specimen in the operating room, plaque ulceration correlates with an initial presentation of amaurosis fugax, TIA, or prior stroke compared with patients operated on for asymptomatic disease. The presence of intraplaque hemorrhage is associated with more advanced stenosis of the internal carotid artery. These findings suggest that plaque morphology does play an important role in the presentation of carotid artery disease.