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We reviewed photographs of 256 primary cutaneous melanomas to determine the gross morphological correlates of metastases. Seven and a half years after diagnosis, the melanomas with ulceration occupying at least 80% of their surface had... more
We reviewed photographs of 256 primary cutaneous melanomas to determine the gross morphological correlates of metastases. Seven and a half years after diagnosis, the melanomas with ulceration occupying at least 80% of their surface had the highest rate of metastases (85%), and melanomas without a nodule had the lowest metastatic rate (11%). Melanomas with nodules had a metastatic rate of 62%, and this rate increased in direct proportion to nodule diameter. Even after adjusting for nodule diameter and ulceration, melanomas with single nodules located completely within the confines of an associated plaque had half of the metastatic rate of melanomas with nodules located at the periphery (abutting normal skin). These data suggest that (1) carefully recorded gross pathological data can augment the microscopic pathological data in the determination of prognosis; (2) skin lesions suspected to be melanoma should be photographed; (3) the photograph, if followed by surgical removal of the lesion, should be attached to the pathology report in the patient's permanent medical record; (4) nodule diameter is better correlated with metastases than the total lesion diameter (as traditionally held); and (5) the cytologically malignant melanocytes that constitute the less-raised portion of most melanomas may not be biologically malignant, thus enlarging the precursor concept for malignant melanoma. The TNM staging system for malignant melanoma could be modified to incorporate these data.
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Clinical studies of systemic lupus erythematosus (SLE) often necessitate assessment of previous disease activity, which is sometimes only possible by retrospective evaluation of information from the medical record. Using the Systemic... more
Clinical studies of systemic lupus erythematosus (SLE) often necessitate assessment of previous disease activity, which is sometimes only possible by retrospective evaluation of information from the medical record. Using the Systemic Lupus Activity Measure (SLAM), the present study compared an assessment of disease activity obtained by chart abstraction with a direct clinical assessment. A chart SLAM was obtained using information abstracted from the clinic notes of 46 patients with SLE who were being followed up at a referral center. Chart SLAM scores were compared with SLAM scores derived from an independent assessor's direct clinical evaluation. Direct SLAM and chart SLAM scores were correlated (r = 0.67 by Spearman's rank correlation, P = 0.0001). Chart review scores for disease activity tended to be lower, but to an inconsistent degree, reflecting both under- and overestimation of disease activity. The overall misclassification rate on a 3-category scale (mild, moderate, or severe activity) was 59%. Although chart SLAM scores were highly correlated with direct SLAM scores, misclassification of disease activity by chart review cannot be rectified. Thus, in research, medical record review should not be used as a proxy for the direct SLAM, nor should it be considered comparable with clinical assessments in the analysis of disease activity.
Research Interests: Immunology, Comparative Study, Medicine, Humans, Systemic Lupus Erythematosus, and 13 moreFemale, Male, Clinical Sciences, Middle Aged, Adult, Public health systems and services research, Retrospective Studies, Reproducibility of Results, Disease Activity, Medical Records, Medical Record, Severity of Illness Index, and Outcome assessment (Health care)
Although it is common for rheumatologists to initiate biologics after failure of methotrexate monotherapy in rheumatoid arthritis (RA), ample data supports the initial use of combinations of conventional therapies in this clinical... more
Although it is common for rheumatologists to initiate biologics after failure of methotrexate monotherapy in rheumatoid arthritis (RA), ample data supports the initial use of combinations of conventional therapies in this clinical scenario. Our study explores the durability of triple therapy (methotrexate, sulfasalazine, and hydroxychloroquine) versus methotrexate-etanercept in RA. RA patients with suboptimal response to methotrexate (n = 353) were randomized to either triple therapy or methotrexate-etanercept therapy in a 48-week, double-blinded, non-inferiority trial. Patients without clinical improvement at 24 weeks were switched to the alternative treatment. Of the total, 289 participated in follow-up. We report treatment durability, Disease Activity Score (DAS28), and other measures during an open-label extension for an additional period up to 72 weeks. Mean duration of open-label follow-up was 11 (± 6) months. The likelihood of continuing on conventional therapy at one year wa...
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The mortality and complication rates of many surgical procedures are inversely related to hospital procedure volume. The objective of this study was to determine whether the volumes of primary and revision total hip replacements performed... more
The mortality and complication rates of many surgical procedures are inversely related to hospital procedure volume. The objective of this study was to determine whether the volumes of primary and revision total hip replacements performed at hospitals and by surgeons are associated with rates of mortality and complications. We analyzed claims data of Medicare recipients who underwent elective primary total hip replacement (58,521 procedures) or revision total hip replacement (12,956 procedures) between July 1995 and June 1996. We assessed the relationship between surgeon and hospital procedure volume and mortality, dislocation, deep infection, and pulmonary embolus in the first ninety days postoperatively. Analyses were adjusted for age, gender, arthritis diagnosis, comorbid conditions, and income. Analyses of hospital volume were adjusted for surgeon volume, and analyses of surgeon volume were adjusted for hospital volume. Twelve percent of all primary total hip replacements and 49% of all revisions were performed in centers in which ten or fewer of these procedures were carried out in the Medicare population annually. In addition, 52% of the primary total hip replacements and 77% of the revisions were performed by surgeons who carried out ten or fewer of these procedures annually. Patients treated with primary total hip replacement in hospitals in which more than 100 of the procedures were performed per year had a lower risk of death than those treated with primary replacement in hospitals in which ten or fewer procedures were performed per year (mortality rate, 0.7% compared with 1.3%; adjusted odds ratio, 0.58; 95% confidence interval, 0.38, 0.89). Patients treated with primary total hip replacement by surgeons who performed more than fifty of those procedures in Medicare beneficiaries per year had a lower risk of dislocation than those who were treated by surgeons who performed five or fewer of the procedures per year (dislocation rate, 1.5% compared with 4.2%; adjusted odds ratio, 0.49; 95% confidence interval, 0.34, 0.69). Patients who had revision total hip replacement done by surgeons who performed more than ten such procedures per year had a lower rate of mortality than patients who were treated by surgeons who performed three or fewer of the procedures per year (mortality rate, 1.5% compared with 3.1%; adjusted odds ratio, 0.65; 95% confidence interval, 0.44, 0.96). Patients treated at hospitals and by surgeons with higher annual caseloads of primary and revision total hip replacement had lower rates of mortality and of selected complications. These analyses of Medicare claims are limited by a lack of key clinical information such as operative details and preoperative functional status.
Research Interests: Biomedical Engineering, Health Services Research, Comorbidity, Hospitals, Policy making, and 17 moreHumans, United States, Female, Male, Orthopedics, Dislocations, Workload, Total Hip Replacement, Medicare, Clinical Sciences, Aged, Clinical Competence, Hospital Mortality, Logistic Models, Functional Status, Confidence Interval, and Mortality rate
Research Interests: Entomology, Education, Health Promotion, Health Education, Risk, and 22 morePublic Health, Adolescent, Prevention, Ticks, Lyme disease, Humans, Measurement, Female, Animals, Male, Massachusetts, Randomised Controlled Trial, Aged, Middle Aged, Questionnaires, Adult, Randomized Controlled Trial, SECONDARY PREVENTION, Primary Prevention, Confidence Interval, Intervals, and Relative Risk
Previous studies suggest that concurrent Lyme disease and babesiosis produce a more sever illness than either disease alone. The majority of babesiosis infections, however, are subclinical. Our objective was to characterize on the basis... more
Previous studies suggest that concurrent Lyme disease and babesiosis produce a more sever illness than either disease alone. The majority of babesiosis infections, however, are subclinical. Our objective was to characterize on the basis of a total-population survey of Nantucket Island, Massachusetts, whether coexposure to Lyme disease and babesiosis causes more severe illness or poorer long-term outcomes than Lyme disease alone. In this retrospective cohort study, residents indicating a history of Lyme disease were compared with randomly selected population controls on a standardized medical history, blinded physical examination, and serological studies for Borrelia burgdorferi and Babesia microti. Serological evidence of exposure to babesiosis was not associated with increased severity of acute Lyme disease. The groups did not differ with regard to the prevalence of constitutional, musculoskeletal, or neurological symptoms a mean of 6 years after acute Lyme disease. Prior Lyme disease and serological exposure to B. microti are not associated with poorer long-term outcomes or more persistent symptoms Lyme disease alone.
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Research Interests: Orthopedic Surgery, Epidemiology, Immunology, Treatment, Public Health, and 17 moreSocial Class, Hospitals, General Surgery, Multivariate Analysis, Humans, Female, Male, Patient Satisfaction, Arthritis, Total Hip Replacement, Total, Clinical Sciences, Aged, Public health systems and services research, Inpatients, Functional Status, and Cohort Studies
There is little information on the effect of nonsurgical factors or postoperative anemia on achieving spinal fusion. In a prospective cohort study of 184 consecutive lumbar spinal fusions, we obtained data on socioeconomic, clinical,... more
There is little information on the effect of nonsurgical factors or postoperative anemia on achieving spinal fusion. In a prospective cohort study of 184 consecutive lumbar spinal fusions, we obtained data on socioeconomic, clinical, radiologic, and traditional surgical factors and analyzed associations between these factors and fusion status at 6 months post surgery. The overall fusion rate was 74%. Among the surgical factors, use of pedicle screw fixation (p = 0.005) predicted fusion success; postoperative anemia (hematocrit < 30%; p = 0.003) and a history of smoking (p = 0.050) predicted fusion failure. However, when the surgical factors were analyzed together with clinical and socioeconomic factors, back pain greater than or equal to leg pain (p < 0.001) and patients working at the initial visit (p = 0.001) predicted fusion success; shoulder pain at the initial visit (p < 0.001) and a family history of back surgery (p = 0.006) predicted fusion failure. These factors were stronger predictors of fusion status than were traditional surgical factors.
Research Interests: Orthopedic Surgery, Complementary and Alternative Medicine, Forecasting, Wound Healing, Adolescent, and 17 moreMultivariate Analysis, Prospective studies, Humans, Female, Male, Fusion, Socioeconomic Status, Clinical Sciences, Aged, Middle Aged, Fixation, Adult, Melting, Spinal, Spinal Fusion, Cohort Studies, and lumbar vertebrae
Research Interests: Treatment, Diet, Vitamin D, Public Health, Adolescent, and 19 moreComparative Study, Prevention, Family history, Humans, Female, Melanoma, Male, Food Frequency Questionnaire, Risk factors, Epidermis, Clinical Sciences, Solar radiation, Adult, Risk Factors, INVESTIGATIVE, Case Control Study, Case Control Studies, Skin Neoplasms, and ultraviolet-B radiation
Bladder cancer screening faces several obstacles, including low yield, numerous false-positive results, and the absence of a single effective screening test. We present a model of a screening program that (1) targets an occupational... more
Bladder cancer screening faces several obstacles, including low yield, numerous false-positive results, and the absence of a single effective screening test. We present a model of a screening program that (1) targets an occupational cohort exposed to a putative carcinogen, to increase the detection of disease, (2) uses four screening tests in parallel to maximize case detection, and (3) defines a diagnostic protocol that minimizes the number of invasive procedures by utilizing both flexible and rigid cystoscopy. In a hypothetical cohort of 1000 men aged 45 to 74 years potentially exposed to a bladder carcinogen, the model would find eight of the nine detectable cancers, with a sensitivity of 89% and a specificity of 78%. In addition, the model allows the sensitivities, specificities, and predictive values of the individual screening tests to be compared and evaluated in a single cohort.
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Research Interests: Treatment Outcome, Osteoarthritis, Clinical Practice, Humans, Physical Health, and 15 moreFemale, Male, Follow-up studies, Total Hip Replacement, Health Status, Clinical Sciences, Computer Graphic, Middle Aged, Evaluation Studies, Cross Section, Sensitivity and Specificity, Outcome Assessment, Cross Sectional Studies, Physical Function, and Statistical Graphics
Dramatic increases in melanoma incidence and more moderate increases in the death rate have been observed. Although paradoxes exist, most, but not all, melanomas appear to be related in some way to solar exposure and genetic factors. No... more
Dramatic increases in melanoma incidence and more moderate increases in the death rate have been observed. Although paradoxes exist, most, but not all, melanomas appear to be related in some way to solar exposure and genetic factors. No other exogenous factor has been strongly implicated.
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Although intermittent intense solar exposure and genetic traits such as fair skin continue to be associated with the risk of developing cutaneous melanoma, these factors fail to account for much of the incidence. Suggestive evidence has... more
Although intermittent intense solar exposure and genetic traits such as fair skin continue to be associated with the risk of developing cutaneous melanoma, these factors fail to account for much of the incidence. Suggestive evidence has increased speculation that viral agents, radiation, hormones, chemicals in the workplace, and dietary factors play some etiologic role.
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Increase in splenic uptake of Tc-99m sulfur colloid was noted in 47 of 147 (32% ) patients with cutaneous malignant melanoma early in the course of dis ease. Patients with disseminated disease and/or clinical or laboratory evidence of... more
Increase in splenic uptake of Tc-99m sulfur colloid was noted in 47 of 147 (32% ) patients with cutaneous malignant melanoma early in the course of dis ease. Patients with disseminated disease and/or clinical or laboratory evidence of hepatic dysfunction were excluded from study. Recurrence rate of 2 yr was higher for those patients with splenic scans demonstrating augmented uptake
Increase in splenic uptake of Tc-99m sulfur colloid was noted in 47 of 147 (32%) patients with cutaneous malignant melanoma early in the coure of disease. Patients with disseminated disease and/or clinical or laboratory evidence of... more
Increase in splenic uptake of Tc-99m sulfur colloid was noted in 47 of 147 (32%) patients with cutaneous malignant melanoma early in the coure of disease. Patients with disseminated disease and/or clinical or laboratory evidence of hapatic dysfunction were excluded from study. Recurrence rate of 2 yr was higher for those patients with splenic scans demonstrating augmented uptake compared with patients having normal scans, 36% against 16% (p less than 0.02). These differences resulted from a much more favorable prognosis in women with normal scans contrasted with women with increased uptake, 6% against 26% (p less than 0.05). Women with increased splenic uptake, and all men regardless of scan status, seemed to have a higher rate of recurrence than women with normal spleen scans. Scan status may be an adjunctive prognostic marker in women.
Research Interests: Spleen, Humans, Liver, Beta decay, Female, and 9 moreMelanoma, Male, Colloids, Clinical Sciences, Sulfur, Malignant Melanoma, Neoplasms, Technetium, and Skin Neoplasms
Missing data pose a serious challenge to the integrity of randomized clinical trials, especially of treatments for prolonged illnesses such as schizophrenia, in which long-term impact assessment is of great importance, but the follow-up... more
Missing data pose a serious challenge to the integrity of randomized clinical trials, especially of treatments for prolonged illnesses such as schizophrenia, in which long-term impact assessment is of great importance, but the follow-up rates are often no more than 50%. Sensitivity analysis using Bayesian modeling for missing data offers a systematic approach to assessing the sensitivity of the inferences made on the basis of observed data. This paper uses data from an 18-month study of veterans with schizophrenia to demonstrate this approach. Data were obtained from a randomized clinical trial involving 369 patients diagnosed with schizophrenia that compared long-acting injectable risperidone with a psychiatrist's choice of oral treatment. Bayesian analysis utilizing a pattern-mixture modeling approach was used to validate the reported results by detecting bias due to non-random patterns of missing data. The analysis was applied to several outcomes including standard measures o...
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The authors evaluated the relative responsiveness to change of generic versus disease-specific and unweighted versus weighted health status measures in carpal tunnel syndrome (CTS). Data were obtained from 196 subjects followed in a... more
The authors evaluated the relative responsiveness to change of generic versus disease-specific and unweighted versus weighted health status measures in carpal tunnel syndrome (CTS). Data were obtained from 196 subjects followed in a prospective community-based cohort study in Maine who underwent carpal tunnel release (The Maine Carpal Tunnel Syndrome Study). Patients were evaluated before and 6 months after surgery. The disease-specific, unweighted severity score was derived from the validated Carpal Tunnel Syndrome Assessment Questionnaire. Patients were asked to rate the importance of each symptom included in the severity score. Each severity question was weighted by its importance, creating a disease-specific weighted score. Generic instruments were the SF-36, SF-12, and a Quality of Life Rating Scale. Sensitivity to change was calculated with the standardized response mean (SRM, mean change/standard deviation of change) as well as the effect size (ES, mean change/standard deviat...
Research Interests: Quality of life, Treatment Outcome, Applied Economics, Prospective studies, Humans, and 13 moreFemale, Male, Patient Satisfaction, Medical Care, Carpal Tunnel Syndrome, Maine, Middle Aged, Questionnaires, Adult, Public health systems and services research, Sensitivity and Specificity, Postoperative Period, and Medical
Data concerning risk factors for the development of cutaneous malignant melanoma (MM) were abstracted from published case-control studies. Relative risks (more appropriately "odds ratios") and 95% confidence intervals were... more
Data concerning risk factors for the development of cutaneous malignant melanoma (MM) were abstracted from published case-control studies. Relative risks (more appropriately "odds ratios") and 95% confidence intervals were quoted or calculated for each risk factor in each study. Those risk factors that were reported to be significant in over half of the studies include: phenotypic factors (blue eyes, blond or red hair, light complexion, freckles, sun sensitivity, and inability to tan); personal history of non-melanoma cutaneous cancer or precancer; higher socioeconomic status; increased numbers of nevocytic nevi; and bursts of sun exposure. Further study is needed on family history and personal history of MM; these were not found to be significant risk factors in over half the reviewed case-control studies. This review leaves out other undoubtedly important risk factors such as dysplastic nervus syndrome and race, which need investigation by the case-control method. Determ...
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Although the precise etiology of melanoma remains unknown, much data link sunlight to melanoma. The imperfect evidence associating sun exposure (particularly UVB radiation) with melanoma emerges from human data, obviating problems... more
Although the precise etiology of melanoma remains unknown, much data link sunlight to melanoma. The imperfect evidence associating sun exposure (particularly UVB radiation) with melanoma emerges from human data, obviating problems inherent in extrapolation from animal and other models. However, the mechanism by which sunlight might possibly initiate or promote melanoma remains obscure. Some clarification should emerge from the potential isolation of genes that carry susceptibility to melanoma in families prone to the disease; such work could serve as a basis to distinguish genetic and environmental influences in melanoma [167]. Continued studies of faulty DNA repair in XP patients may elucidate the steps in mutagenesis and carcinogenesis. Future case-control studies must address the limits on the accuracy of recall and the limits on statistical methods to separate the cluster of phenotypic risk needed in determining biologically effective dose. Animal and in vitro studies must contribute more insight. Further research in the South American opossum models appears promising [72]. Although ozone depletion has been documented, there has been little definitive evidence of subsequent increase of UVB at the Earth's surface. Nevertheless, the threat posed by ozone depletion deserves continued environmental action and public education. The role of precursor lesions, particularly dysplastic nevi/atypical moles, must be clarified with future research. The distribution of melanoma among various work forces suggests that occupational risk factors may play an important role in the etiology of this disease [168-170]. The consistent reports of excess melanoma among accountants, clerical workers, professional workers, and teachers deserve further study. Furthermore, evidence of excesses in printing and press, petrochemical, and the telecommunications industries require follow-up. Carefully planned studies that account for nonoccupational risk factors are recommended. Research over the last four decades has brought much information about melanoma etiology. More work is needed to learn the precise cause and ultimately to prevent avoidable mortality from malignant melanoma.
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The measurement of the... more
The measurement of the patient's experience with a condition or an illness is an important and quantifiable outcome and an example of action research. By making these concerns paramount, the goals and processes of health care can be redirected from anatomical and physiologic restoration to patient-oriented outcomes. At the same time, research can illuminate the complex mechanisms responsible. Critical, analytic synthesis and review of the research evaluating the ability of self-administered questionnaires to capture clinically meaningful changes. Responsiveness is differentiated from sensitivity, and statistical methods for evaluating sensitivity of instruments are referenced. Techniques for evaluating whether differences in instrument sensitivity could have occurred by chance are presented, and methods for assessing a clinically meaningful change are discussed. Responsiveness is the key psychometric property of an instrument if it is to be incorporated into daily practice. Improving responsiveness is a major research priority.
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ABSTRACT
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Research Interests: Health Behavior, Preventive medicine, Adolescent, Humans, Skin Cancer, and 20 moreUnited States, Female, Male, Skin, Aged, Middle Aged, Skin Pigmentation, Adult, Public health systems and services research, Curriculum and Pedagogy, Health surveys, European Continental Ancestry Group, Logistic Regression Model, Sunlight, Logistic Models, Protective Clothing, Confidence Interval, Skin Neoplasms, Sunburn, and National Health Interview Survey
The emergence of revised definitions for the high-risk patient with cutaneous malignant melanoma prompts us to re-examine the current status of adjuvant therapy in this disease. We wish to address the question, "once a cutaneous... more
The emergence of revised definitions for the high-risk patient with cutaneous malignant melanoma prompts us to re-examine the current status of adjuvant therapy in this disease. We wish to address the question, "once a cutaneous melanoma is surgically removed and the patient is currently free of disease but at high risk for metastases, what can be done to prevent recurrence"?
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Pre-treatment of patients with clopidogrel prior to coronary angiography (CAG) and possible percutaneous coronary intervention (PCI) is a standard practice. Candidates for coronary artery bypass surgery (CABG) are discharged or remain in... more
Pre-treatment of patients with clopidogrel prior to coronary angiography (CAG) and possible percutaneous coronary intervention (PCI) is a standard practice. Candidates for coronary artery bypass surgery (CABG) are discharged or remain in the hospital until CABG after clopidogrel is discontinued. We investigated whether any differences exist in the rates of surgical complications and outcomes between these two groups of patients. We conclude that continued hospitalization of clopidogrel pre-treated patients does not confer any safety benefit with regard to post-operative complications and 30-day mortality. Discharging these patients after CAG may reduce hospitalization costs.
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In a prospective epidemiologic study of 1001 middle-aged men, we examined the relation between dietary information collected approximately 20 years ago and subsequent mortality from coronary heart disease. The men were initially enrolled... more
In a prospective epidemiologic study of 1001 middle-aged men, we examined the relation between dietary information collected approximately 20 years ago and subsequent mortality from coronary heart disease. The men were initially enrolled in three cohorts: one of men born and living in Ireland, another of those born in Ireland who had emigrated to Boston, and the third of those born in the Boston area of Irish immigrants. There were no differences in mortality from coronary heart disease among the three cohorts. In within-population analyses, those who died of coronary heart disease had higher Keys (P = 0.06) and modified Hegsted (P = 0.02) dietary scores than did those who did not (a high score indicates a high intake of saturated fatty acids and cholesterol and a relatively low intake of polyunsaturated fatty acids). These associations were significant (P = 0.03 for the Keys and P = 0.04 for the modified Hegsted scores) after adjustment for other risk factors for coronary heart disease. Fiber intake (P = 0.04) and a vegetable-foods score, which rose with increased intake of fiber, vegetable protein, and starch (P = 0.02), were lower among those who died from coronary heart disease, though not significantly so after adjustment for other risk factors. A higher Keys score carried an increased risk of coronary heart disease (relative risk, 1.60), and a higher fiber intake carried a decreased risk (relative risk, 0.57). Overall, these results tend to support the hypothesis that diet is related, albeit weakly, to the development of coronary heart disease.
Research Interests: Physiology, Epidemiology, Nutrition, Research Methodology, Biology, and 22 moreDiet, Population Dynamics, Health, Ireland, Prospective studies, Population, Humans, Fatty acids, Male, Vegetables, Boston, Aged, Middle Aged, Developed Countries, Adult, New England, Coronary heart disease, Dietary fiber, Cohort Analysis, Dietary Carbohydrates, New England Journalof Medicine, and Dietary fats
Topical 5% 5-fluorouracil (5-FU) is known to cause toxicity, such as erythema, pain, and crusting/erosions. We sought to develop a scale to measure this toxicity and test the scale for reliability. A scale was developed involving four... more
Topical 5% 5-fluorouracil (5-FU) is known to cause toxicity, such as erythema, pain, and crusting/erosions. We sought to develop a scale to measure this toxicity and test the scale for reliability. A scale was developed involving four parameters: erythema severity, percentage of face involved in erythema, crusting/erosions severity, and percentage of face involved in crusting/erosions. Thirteen raters graded 99 sets of photographs from the Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial using these parameters. Intraclass correlation overall for 13 raters was 0.82 (95% CI 0.77-0.86). There was no statistically significant trend in reliability by level of training in dermatology. This scale is a reliable method of evaluating the severity of toxicity from topical 5-fluorouracil and can be used by dermatologists and nondermatologists alike.
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Topical 5% 5-fluorouracil (5-FU) is known to cause toxicity, such as erythema, pain, and crusting/erosions. We sought to develop a scale to measure this toxicity and test the scale for reliability. A scale was developed involving four... more
Topical 5% 5-fluorouracil (5-FU) is known to cause toxicity, such as erythema, pain, and crusting/erosions. We sought to develop a scale to measure this toxicity and test the scale for reliability. A scale was developed involving four parameters: erythema severity, percentage of face involved in erythema, crusting/erosions severity, and percentage of face involved in crusting/erosions. Thirteen raters graded 99 sets of photographs from the Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial using these parameters. Intraclass correlation overall for 13 raters was 0.82 (95% CI 0.77-0.86). There was no statistically significant trend in reliability by level of training in dermatology. This scale is a reliable method of evaluating the severity of toxicity from topical 5-fluorouracil and can be used by dermatologists and nondermatologists alike.
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Research Interests: Decision Analysis, Sensitivity Analysis, Decision Trees, Humans, Skin Cancer, and 13 moreCost Effectiveness Analysis, United States, Melanoma, Cancer Screening, Cost effectiveness, Life Expectancy, Clinical Sciences, Prevalence, Malignant Melanoma, Cost Benefit Analysis, Sensitivity and Specificity, The American, and Skin Neoplasms
Pre-treatment of patients with clopidogrel prior to coronary angiography (CAG) and possible percutaneous coronary intervention (PCI) is a standard practice. Candidates for coronary artery bypass surgery (CABG) are discharged or remain in... more
Pre-treatment of patients with clopidogrel prior to coronary angiography (CAG) and possible percutaneous coronary intervention (PCI) is a standard practice. Candidates for coronary artery bypass surgery (CABG) are discharged or remain in the hospital until CABG after clopidogrel is discontinued. We investigated whether any differences exist in the rates of surgical complications and outcomes between these two groups of patients. We conclude that continued hospitalization of clopidogrel pre-treated patients does not confer any safety benefit with regard to post-operative complications and 30-day mortality. Discharging these patients after CAG may reduce hospitalization costs.
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Research Interests: Public Opinion, Health Education, Dermatology, Probability, Television, and 23 moreNewspapers, Humans, Skin Cancer, Ultraviolet, United States, Female, Melanoma, Male, Weather, Government Agencies, Weather Forecasting, Clinical Sciences, Middle Aged, Survey data, Family Health, Adult, Telephone, Communications Media, Indexation, Environmental Protection Agency, Sunlight, The American, and Skin Neoplasms
Research Interests: Program Evaluation, Health Education, Adolescent, England, Low back pain, and 12 moreHumans, Female, Male, Randomised Controlled Trial, Aged, Middle Aged, Adult, Postal Service, Occupational therapy services in mental health services, Occupational Diseases, Wounds and Injuries, and New England Journalof Medicine
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Responsiveness, the ability to detect meaningful clinical change, is a critical attribute of instruments used to evaluate outcomes of treatments. The authors hypothesized that self-administered symptom severity and functional status... more
Responsiveness, the ability to detect meaningful clinical change, is a critical attribute of instruments used to evaluate outcomes of treatments. The authors hypothesized that self-administered symptom severity and functional status questionnaires are more responsive to clinical improvement after carpal tunnel release than traditional physical examination measures of strength and sensibility. Data were obtained from a randomized clinical trial of endoscopic versus open carpal tunnel release conducted in four university medical centers. Patients were evaluated before surgery and 3 months after surgery. Seventy-four patients indicating that they were more than 80% satisfied with the results of surgery were assumed to have clinically meaningful improvement and were the focus of the analysis. Evaluations included questionnaires assessing symptom severity, functional status, and activities of daily living as well as measurement of grip, pinch, and abductor pollicus brevis strength, and 2-point discrimination and Semmes-Weinstein pressure sensibility. Responsiveness was calculated with the standardized response mean (mean change/standard deviation of change) as well as the effect size (mean change/standard deviation of baseline values). The symptom severity scale was four times as responsive, and the functional status and activities of daily living scales were twice as responsive, as the measures of strength and sensibility. Self-administered symptom severity and functional status scales are much more responsive to clinical improvement than measures of neuromuscular impairment and should severe as primary outcomes in clinical studies of therapy for carpal tunnel syndrome.