Safety and efficacy of alefacept, efalizumab, etanercept and infliximab in treating moderate to severe plaque psoriasis: a meta-analysis of randomized controlled trials.

BACKGROUND: The relatively recent introduction of biological agents to treat psoriasis presents clinicians with the need to objectively compare and contrast these agents to allow more effective treatment of their patients. OBJECTIVES: To evaluate and compare the efficacy and safety of biological agents in the treatment of plaque psoriasis. METHODS: (i) DATA SOURCES: Four parallel systematic reviews conducted through July 2006, including peer-reviewed data and U.S. Food and Drug Administration (FDA) reports. (ii) STUDY SELECTION: Randomized, controlled, double-blind, monotherapy trials of alefacept (n = 3), efalizumab (n = 5), etanercept (n = 4) and infliximab (n = 4); 16 studies comprising 7931 patients met inclusion criteria. (iii) DATA EXTRACTION: Efficacy was measured by Psoriasis Area and Severity Index (PASI) 75 achievement after 10-14 weeks of treatment, using intention-to-treat analysis. Safety was evaluated by the incidence of one or more adverse event(s) (AEs) and serious adverse event(s) (SAEs) during 10-30 weeks of treatment. RESULTS: Pooled relative risk (RR) and number needed to treat (NNT) of PASI 75 achievement compared with placebo was computed using Mantel-Haenszel methods and the random effects model. All biological agents for psoriasis were efficacious (P < 0.001); however, there was a graded response for achievement of PASI 75: infliximab (RR = 17.40, NNT = 2), etanercept (RR = 11.73, NNT = 3), efalizumab (RR = 7.34, NNT = 4) and alefacept (RR = 3.70, NNT = 8). The risk of one or more AEs was evaluated by RR and number needed to harm (NNH). This was increased in the alefacept (RR = 1.09, P = 0.03, NNH = 15), efalizumab (RR = 1.15, P < 0.001, NNH = 9) and infliximab (RR = 1.18, P < 0.001, NNH = 9) groups compared with placebo. SAEs were increased in a sensitivity analysis of four efalizumab trials (n = 2443, RR = 1.92, P = 0.03, NNH = 60). CONCLUSIONS: The decreasing rank order for pooled efficacy was infliximab, etanercept, efalizumab and alefacept when compared with placebo. Pooling safety data revealed a previously unreported increased risk of AEs for alefacept, efalizumab and infliximab.

Cigarette smoking and alcohol consumption in the aetiology of uterine cervical cancer.

A case-control study of uterine cervical cancer was conducted using 331 cases and 993 age-matched controls identified through the Missouri Cancer Registry during 1984-1986. Patients with smoking- or alcohol-related cancers were excluded from the control series. Logistic regression was used to compute odds ratios (ORs) and 95% confidence intervals (Cls) after adjustment for age, cigarette smoking, alcohol consumption, and stage at diagnosis. A dose-response relation was observed between intensity of cigarette smoking and invasive cervical cancer, with light and heavy smokers having elevated risks (OR = 2.2, 95% Cl = 1.4-3.6 and OR = 3.9, 95% Cl = 2.7-5.6, respectively). Former smokers had less elevated risk (OR = 1.7, 95% Cl = 1.0-2.9), a finding consistent with a greater effect of tobacco smoke on late-stage carcinogenesis. Similar results were obtained in age- and control site-specific analyses. Further, the age-specific data suggested a dose-response relation between duration of smoking and invasive cervical cancer. An association between alcohol consumption and invasive cervical cancer was not observed.

Physical fitness is inversely related to heart disease risk: a factor analytic study.

We measured cardiorespiratory endurance, muscular strength and endurance, anaerobic run time, coronary risk factors, and dietary habits in male fire fighters (n = 779, ages 18 to 64 years) and performed factor analysis to determine the interrelationships and underlying factor structure of the data set. Principal component analysis produced nine factors (eigenvalues greater than 1.0) accounting for 61% of the total variance. However, the variable loadings were inconsistent, preventing a meaningful interpretation of the factor solution. These problems were solved through the principal axis method of common factor analysis, which revealed three factors (eigenvalues greater than 1.0) accounting for 29% of the total variance. Orthogonal rotation (varimax method), showed Factors 1, 2, and 3 accounting for 52%, 29%, and 19%, respectively, of the common variance. Factor 1, labeled physical fitness capacity (PFC), included age, situps, treadmill performance time, pushups, maximum exercise heart rate, and anaerobic run time. Factor 2, designated coronary risk status (CRS), included body mass index, resting systolic and diastolic blood pressure, triglycerides, and the total cholesterol-high density lipoprotein cholesterol ratio. Factor 3, termed food frequency intake (FFI), included the weekly intake of fried foods, beef, pork, eggs, caffeine, and cheese. Percentage body fat loaded on both PFC and CRS. Measures such as blood pressure, grip strength, resting heart rate, maximum exercise systolic blood pressure, cigarettes smoked per day, and weekly frequency of milk, fish, fowl, and alcohol intake contributed little to the factor solution. Correlation coefficients after oblique rotation showed PFC to be inversely related to CRS (r = -0.48). However, FFI was independent of PFC (r = 0.07) and CRS (r = -0.10).(ABSTRACT TRUNCATED AT 250 WORDS)

Uterine cervical cancer risk in cigarette smokers: a meta-analytic study.

We conducted a meta-analytic study to measure the risk of uterine cervical cancer in former and current smokers. A literature search from 1966 to 1988 identified 139 MEDLINE citations. Of these, five studies reported appropriate and complete data for meta-analysis. A recent study conducted by the authors was also included. The graphical and variance-based methods of meta-analysis consistently demonstrated a significantly excessive risk of cervical cancer in current smokers, but not in former smokers. The powers of the analyses involving former smokers were between 0.72 and 0.99, depending on the degree of confounding attributed to unmeasured variables. Thus, it was unlikely that sample size accounted for the null association observed in former smokers. These findings have important medical implications for women in light of the prevalence of cigarette smoking. During regular gynecologic screening examinations, health care professionals may have considerable impact by counseling women about the risk of cervical cancer in smokers. Antismoking messages should be strongly directed toward women in the lower educational and socioeconomic levels to have the greatest impact on the incidence of cervical cancer.

Resource utilization and work or school loss reported by patients with diabetes: experience in diabetes training programs.

Diabetes exerts a major economic impact on healthcare in the United States both in terms of direct and indirect costs. Diabetes management and education programs designed to assist patients in achieving more optimal glycemic control represent a potential mechanism for reducing the morbidity and costs associated with diabetes. The relationship between HbA1c and patient hospitalizations and between HbA1c and days lost from work or school related to diabetes within the past year were evaluated. A cohort of 2359 patients with diabetes (188 type I, 2171 type II) referred to a comprehensive diabetes self-management training program was included in the analyses. Overall, 350 (14.8%) patients reported hospitalization, and 212 (9.0%) reported days lost from work or school. Patients with type I diabetes reported more hospitalizations (26.1% vs 13.9% and days lost (19.2% vs 8.1%) than type II patients. For the hospitalization outcome, the multivariate analyses indicated that younger age, the number of co-morbidities, and the duration of diabetes exerted a greater influence on the reported numbers of hospitalization than glycemic control. For the days lost outcome, the multivariate analyses indicated that there was a marginally significant association between patients with poor glycemic control and reported work or school loss related to diabetes (odds ratio = 1.5; 95% confidence interval, 1.0-2.2). These data suggest that interventions that improve glycemic control may decrease indirect costs related to diabetes.

Comparison of health risk prevalence reported in a health risk appraisal and predicted through demographic analysis.

BACKGROUND: The purpose of this study was to determine if the Healthier People Health Risk Appraisal and the RiskPlan Report, two different methods for measuring health risks of an employee population, produce the same estimates of health risk prevalence. METHODS: The prevalence of each of seven risk factors, directly measured by the Healthier People Health Risk Appraisal and predicted by the RiskPlan Report using demographic and normative data, were compared for a group of 239 employees participating in a voluntary health screening. Further, the 239 participants and 426 nonparticipants were compared with respect to demographic factors gleaned from personnel records, and risk factor prevalence derived from the RiskPlan Report. RESULTS: Significant differences were found in the prevalence of six of the seven risk factors measured by the Healthier People Health Risk Appraisal and predicted by the RiskPlan Report. Also, risk factor prevalence predicted by the RiskPlan Report was not significantly different in the participants and nonparticipants although three critical sociodemographic variables were significantly different. DISCUSSION: The results suggest that the prevalence of health risks based on normative data and the demographic profile of a population are not similar to those directly measured, and some doubt is raised about predicting health risks based on these data.

Use of the internet as a resource for consumer health information: results of the second osteopathic survey of health care in America (OSTEOSURV-II).

BACKGROUND: The Internet offers consumers unparalleled opportunities to acquire health information. The emergence of the Internet, rather than more-traditional sources, for obtaining health information is worthy of ongoing surveillance, including identification of the factors associated with using the Internet for this purpose. OBJECTIVES: To measure the prevalence of Internet use as a mechanism for obtaining health information in the United States; to compare such Internet use with newspapers or magazines, radio, and television; and to identify sociodemographic factors associated with using the Internet for acquiring health information. METHODS: Data were acquired from the Second Osteopathic Survey of Health Care in America (OSTEOSURV-II), a national telephone survey using random-digit dialing within the United States during 2000. The target population consisted of adult, noninstitutionalized, household members. As part of the survey, data were collected on: facility with the Internet, sources of health information, and sociodemographic characteristics. Multivariate analysis was used to identify factors associated with acquiring health information on the Internet. RESULTS: A total of 499 (64% response rate) respondents participated in the survey. With the exception of an overrepresentation of women (66%), respondents were generally similar to national referents. Fifty percent of respondents either strongly agreed or agreed that they felt comfortable using the Internet as a health information resource. The prevalence rates of using the health information sources were: newspapers or magazines, 69%; radio, 30%; television, 56%; and the Internet, 32%. After adjusting for potential confounders, older respondents were more likely than younger respondents to use newspapers or magazines and television to acquire health information, but less likely to use the Internet. Higher education was associated with greater use of newspapers or magazines and the Internet as health information sources. Internet use was lower in rural than urban or suburban areas. CONCLUSIONS: The Internet has already surpassed radio as a source of health information but still lags substantially behind print media and television. Significant barriers to acquiring health information on the Internet remain among persons 60 years of age or older, those with 12 or fewer years of education, and those residing in rural areas. Stronger efforts are needed to ensure access to and facility with the Internet among all segments of the population. This includes user-friendly access for older persons with visual or other functional impairments, providing low-literacy Web sites, and expanding Internet infrastructure to reach all areas of the United States.

Factors associated with intended use of a Web site among family practice patients.

BACKGROUND: The World Wide Web has become a widely utilized source of health information. Although the frequency of health related queries is impressive, the demographics associated with patients making queries has not been clearly delineated. OBJECTIVE: This study s objective was to determine health related Internet usage patterns of family medicine patients. METHODS: Internet use among 824 eligible patients 18 years or older attending seven university based family practice clinics during a two week period in November of 1999 was studied. The survey instrument included 10 items and was designed to collect data in less than five minutes using a paper and pencil format. Statistical significance associated with intended Web site use was computed using a multiple logistic regression model. RESULTS: A response rate of 72.2% was observed with 63.1% being females and 36.9% being males. The mean and median age were 44.0 and 45.7 years, respectively. A steady decline in intended Web site use was observed with advancing age with significant differences observed above 65 years (OR = 0.30; 95% CI = 0.14 - 0.64; p<.002). Other significant findings associated with intended use of a Web site by clinic based patients included having a home computer (OR = 1.99; 95%, CI = 1.05 3.76; p<0.03) and having Internet access at home (OR=5.6, 95%, CI = 2.83-11.18; p<.001). A lack of association between intended Web site use and health insurance status was observed. CONCLUSIONS: Results from this study suggest that Web sites are not likely to be alternative sources of health information for the uninsured or elderly in the near future.

Use of Veterans Administration outpatient facilities by older, rural veterans.

A mail survey was conducted in rural northeastern Missouri to study the factors affecting use of Veterans Administration (VA) outpatient medical services by older veterans. During the year preceding the survey, 39.6% of the 169 responding veterans had used VA outpatient facilities. Travel time, long waiting time at the clinic, and travel expense were the most common perceived barriers to use. However, these factors were generally poor predictors of use. The reported percentage of each perceived geographic or administrative barrier to use was consistently greater for previous users than for nonusers of these facilities. Multiple regression analysis revealed private medical insurance coverage to be the only significant predictor of use. Veterans with private medical insurance were more likely to receive ambulatory medical care from local providers than from the VA. The potential impact of removing perceived barriers to use in this population remains unclear.

The planning, development, and implementation of a work-site health promotion program: a case study.

A voluntary health promotion program was introduced at an academic institution with 665 employees. The 239 employees who volunteered to participate in a health risk appraisal were significantly younger and more likely to be female than were nonparticipants. The prevalence rates of the major coronary heart disease risk factors in the participants were as follows: hypercholesterolemia, 25.5%; elevated blood pressure, 15.5%; and current cigarette smoker, 15.1%. In addition, many participants daily consumed food high in cholesterol or fat (54.2%), were obese (44.8%), and led sedentary lifestyles (28.5%). Although a majority of female participants had received physician/nurse breast examinations and had Papanicolaou smears taken during the previous year, only about half this number performed monthly breast self-examinations. A telephone survey of employees revealed the most desired health promotion program components to be stress reduction, nutrition counseling, exercise fitness, and weight reduction. The program is now being monitored for health benefits and program costs.

The evolving role of outcomes measurement and management in healthcare.

The focus on quality and accountability in healthcare has dramatically changed the manner in which clinical services are delivered. The traditional reliance on structural aspects of healthcare delivery has largely given way to a system that closely monitors processes and measures outcomes. Outcomes measurement has intuitive appeal because of its objectivity, global perspective on healthcare, and input from patients, providers, insurers, and payers in the healthcare delivery chain. Nevertheless, outcomes measures are destined to be closely linked to healthcare processes. Data from clinical investigations, interpreted using rigorously developed, evidence-based methodologies, must be used to provide feedback to those designing clinical processes and to continuously improve the quality of healthcare. As outcomes data will be crucial in evaluating the quality of services provided by managed care organizations in relation to their costs, it is imperative that osteopathic physicians become conversant with the history and evolution of outcomes measurement and management.

Health hazards reported by international travelers.

International travel projections suggest that physicians will be increasingly involved in counseling their traveling patients on the prevention of health hazards. A mail survey of 121 returning international travelers indicated that their leading problems involved drinking water (odds ratio [OR], 19.4; 95% confidence interval [CI], 9.6 to 39.1), sanitation (OR, 13.8; 95% CI, 6.9 to 27.5), jet lag (OR, 12.4; 95% CI, 6.2 to 24.6), and food (OR, 9.5; 95% CI, 4.8 to 18.8). Medication for treatment of travelers' diarrhea and countermeasures for jet lag were not significantly associated with better outcomes. Compliance with malaria chemoprophylaxis was greater than previously reported.

The physical fitness of first-year osteopathic medical students.

The authors studied the physical fitness of first-year students attending an osteopathic medical college between 1981 and 1986. Overall, 319 (49.2%) of all students entering during this period participated in a comprehensive health and fitness assessment. The mean treadmill performance times for men and women were 20.4 minutes and 15.5 minutes, respectively, using a modified Balke protocol. Men and women were at the 72nd and 79th percentiles, respectively, for physical fitness. In multivariate regression models that adjusted for confounding variables, body fat percentage was a highly significant negative predictor of fitness in both men and women. Forced vital capacity was also a highly significant predictor in women. The results of the study suggest that the fitness of medical students can be improved by implementing health promotion measures that encourage regular physical activity and dietary modification. A greater emphasis on health promotion in the medical curriculum may help students to adopt more healthy behaviors and, in addition, encourage them to provide preventive medical counseling to their patients.

Characteristics, satisfaction, and perceptions of patients receiving ambulatory healthcare from osteopathic physicians: a comparative national survey.

A national telephone survey was conducted in 1998 using random-digit dialing and the first Osteopathic Survey of Healthcare in America (OSTEOSURV-I) instrument to determine patients' satisfaction with their healthcare, as well as their perceptions of osteopathic medicine. Of the 1106 respondents, 243 (22.0%) had received medical care from an osteopathic physician, and another 307 (27.8%) claimed to be aware of osteopathic physicians. Patients of osteopathic physicians reported the highest levels of satisfaction in 8 of the 11 elements studied when compared with patients of allopathic physicians, chiropractors, and nonphysician clinicians other than chiropractors. Respondents perceived osteopathic manipulative treatment (OMT) to be beneficial for musculoskeletal disorders (P < .001). In addition, respondents perceived that healthcare services provided by osteopathic physicians were similar to those provided by allopathic physicians (P < .001), but not to those provided by chiropractors (P = .01). A total of 97.9% of current patients of osteopathic physicians agreed with the statement that osteopathic physicians practiced in their local community, compared with 80.6% of former patients of osteopathic physicians and 67.8% of patients who had never visited osteopathic physicians (P < .001). In general, the most favorable perceptions of osteopathic medicine were reported by current patients of osteopathic physicians, followed by former patients of such physicians. The least favorable perceptions came from patients who had never been patients of osteopathic physicians. The perception that OMT should be covered by health insurance was significantly associated with the use of osteopathic physicians (odds ratio, 3.2; 95% confidence interval, 1.5 to 6.7, among patients who had ever been to an osteopathic physician). The results of our survey suggest that greater access to osteopathic services, including OMT, is desirable and that promotional efforts aimed at encouraging the use of osteopathic medical services among the general population are warranted.

Factors associated with the vaccination of international travelers: a multivariate analysis.

Travel medicine practice in the United States has not been extensively studied. This study included 1078 consecutive patients who presented to a university-based travel medicine clinic from 1990 through 1994. Analyses of patient demographics, clinic attendance, itineraries, and vaccinations were conducted. Mean patient age (+/- SD) was 37.4 +/- 16.2 years; 626 (58.1%) of the patients were male. Travel duration was 103.1 +/- 242.3 days (median, 21 days), and lead time (defined as the time between clinic presentation and departure for the purpose of this study) was 23.8 +/- 26.5 days (median, 16 days). Destination was the strongest independent factor affecting vaccination practices. A lead time of 31 or more days was associated with significantly elevated odds ratios for all immunobiologicals except immune globulin. These findings underscore the need to educate the traveling public, healthcare providers, and the travel industry about the benefits of seeking medical consultation at least 1 month prior to international travel.

Projected incidence of cardiovascular disease in male firefighters based on current risk factor prevalence.

The projected incidence of cardiovascular disease (CVD) in male firefighters was determined by the prevalence of current CVD risk factors and the use of the Framingham Study general cardiovascular risk profile in a probability sample of firefighters from two municipal fire departments. Hypercholesterolemia (60.9%) and obesity (56.0%) were the most prevalent risk factors. Significant age-related trends were observed for the prevalence of all CVD risk factors, except glucose intolerance (P = .21) and an abnormal resting electrocardiogram (P = .07). The projected incidence of CVD in firefighters did not differ from that of the general male population (relative risk, 1.0; 95% confidence interval, 0.7 to 1.4); similar risk estimates were observed in age-specific analyses. These findings are in accord with previous incidence and mortality studies that used circulatory diseases as an end point. The present method should be viewed primarily as a hypothesis-generating tool because of its limitations in assessing cause and effect.