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    Robert Lew

    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.
    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.
    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...
    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.
    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.
    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.
    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.
    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.
    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.
    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
    Topical fluorouracil was demonstrated to be effective in reducing the number of actinic keratoses (AKs) for up to 6 months, but no randomized trials studied its long-term efficacy. To evaluate the long-term efficacy of a single course of... more
    Topical fluorouracil was demonstrated to be effective in reducing the number of actinic keratoses (AKs) for up to 6 months, but no randomized trials studied its long-term efficacy. To evaluate the long-term efficacy of a single course of fluorouracil cream, 5%, for AK treatment. The Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) trial was a randomized, double-blinded, placebo-controlled trial with patients from dermatology clinics at 12 VA medical centers recruited from 2009 to 2011 and followed up until 2013. Our study population comprised 932 veterans with 2 or more keratinocyte carcinomas in the 5 years prior to enrollment. The mean follow-up duration was 2.6 years in both treatment and control groups. Participants applied either topical fluorouracil cream, 5% (n = 468), or vehicle control cream (n = 464) to the face and ears twice daily for up to 4 weeks. This study reports on AK counts and treatments, which were secondary outcomes of the VAKCC trial. Actinic keratoses on the face and ears were counted by study dermatologists at enrollment and at study visits every 6 months. The number of spot treatments for AKs on the face and ears at semiannual study visits and in between study visits was recorded. The number of AKs on the face and ears per participant was not different between the fluorouracil and control groups at randomization (11.1 vs 10.6, P > .10). After randomization, the fluorouracil group had fewer AKs compared with the control group at 6 months (3.0 vs 8.1, P < .001) and for the overall study duration (P < .001). The fluorouracil group also had higher complete AK clearance rates (38% vs 17% at 6 months) and fewer spot treatments at 6-month intervals, at study visits, and in between study visits during the trial (P < .01 for all). The fluorouracil group took longer to require the first spot AK treatment (6.2 months) compared with the control group (6.0 months)…
    For post-Mohs surgical defects of the head and neck, the width of the defect is the best predictor of the length of that time it will take the wound to heal. This conclusion is based on a multivariate analysis, testing the effect of the... more
    For post-Mohs surgical defects of the head and neck, the width of the defect is the best predictor of the length of that time it will take the wound to heal. This conclusion is based on a multivariate analysis, testing the effect of the following factors on wound-healing time: (1) age, (2) sex, (3) sound location, (4) wound width, (5) wound length, and (6) wound length X wound width. After accounting for wound width, none of the other factors significantly influenced the rate of wound healing. The 64 wounds evaluated were dressed daily with one of five bandages. When compared with the controls, and after correcting for wound width, each of the test bandages shortened wound-healing time. Among the treatment groups, no significant differences were found in the cultures or in the appearance of the wounds.
    Every prospective study published to date, whether randomized or nonrandomized, shows that the survival rate for patients with clinical stage I melanoma is the same, irrespective of whether they have an elective lymph node dissection... more
    Every prospective study published to date, whether randomized or nonrandomized, shows that the survival rate for patients with clinical stage I melanoma is the same, irrespective of whether they have an elective lymph node dissection (ELND). All the studies that purport to show a survival benefit from ELND have been based on retrospective data and are therefore subject to selection bias. Nevertheless, the data support the notion that there may be a small, select group of melanoma patients whose lives can be saved by ELND. This subgroup is made up of those patients who have epithelioid in small nests (ESN) melanomas. In the early stages of its evolution, this type of malignant melanoma metastasizes to regional lymph nodes and often does not have coexistent distant metastases. Other types of melanomas, when they metastasize, either bypass the lymph nodes or metastasize to the lymph node and simultaneously send distant metastases elsewhere, nullifying the anticipated benefit from an EL...
    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.
    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...
    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.
    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...
    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...
    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.
    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.
    ABSTRACT
    Prospective multicenter observational study of the outcome of surgery for degenerative lumbar spinal stenosis. To identify correlates of patient satisfaction with the results of surgery. Little published information exists on correlates... more
    Prospective multicenter observational study of the outcome of surgery for degenerative lumbar spinal stenosis. To identify correlates of patient satisfaction with the results of surgery. Little published information exists on correlates of patient satisfaction after surgery for spinal stenosis. Preoperative and 6-month follow-up data for 194 patients were analyzed. Associations between preoperative variables and satisfaction with the results of surgery were examined in univariate and multivariate models. In multiple linear regression models that adjusted for the effects of age, gender, individual surgeon, number of interspaces decompressed, whether a fusion was performed, depression score, and overall level of pain, the predominance of back (as opposed to leg) pain, greater comorbidity, and worse preoperative functional status were associated with lower patient satisfaction. The regression model explained just 15% of the variance in patient satisfaction. Patients bothered predominantly by back pain preoperatively and those with greater medical comorbidity and functional disability are significantly less satisfied with the results of surgery for degenerative lumbar spinal stenosis.
    ABSTRACT
    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"?
    Long-acting injectable risperidone, a second-generation antipsychotic agent, may improve adherence to treatment and outcomes in schizophrenia, but it has not been tested in a long-term randomized trial involving patients with unstable... more
    Long-acting injectable risperidone, a second-generation antipsychotic agent, may improve adherence to treatment and outcomes in schizophrenia, but it has not been tested in a long-term randomized trial involving patients with unstable disease. We randomly assigned patients in the Veterans Affairs (VA) system who had schizophrenia or schizoaffective disorder and who had been hospitalized within the previous 2 years or were at imminent risk for hospitalization to 25 to 50 mg of long-acting injectable risperidone every two weeks or to a psychiatrist's choice of an oral antipsychotic. All patients were followed for up to 2 years. The primary end point was hospitalization in a VA or non-VA psychiatric hospital. Symptoms, quality of life, and functioning were assessed in blinded videoconference interviews. Of 369 participants, 40% were hospitalized at randomization, 55% were hospitalized within the previous 2 years, and 5% were at risk for hospitalization. The rate of hospitalization after randomization was not significantly lower among patients who received long-acting injectable risperidone than among those who received oral antipsychotics (39% after 10.8 months vs. 45% after 11.3 months; hazard ratio, 0.87; 95% confidence interval, 0.63 to 1.20). Psychiatric symptoms, quality of life, scores on the Personal and Social Performance scale of global functioning, and neurologic side effects were not significantly improved with long-acting injectable risperidone as compared with control treatments. Patients who received long-acting injectable risperidone reported more adverse events at the injection site and more extrapyramidal symptoms. Long-acting injectable risperidone was not superior to a psychiatrist's choice of oral treatment in patients with schizophrenia and schizoaffective disorder who were hospitalized or at high risk for hospitalization, and it was associated with more local injection-site and extrapyramidal adverse effects. (Supported by the VA Cooperative Studies Program and Ortho-McNeil Janssen Scientific Affairs; ClinicalTrials.gov number, NCT00132314.).
    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.
    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.
    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.
    1. N Engl J Med. 1981 Nov 5;305(19):1155. The natural break points for primary-tumor thickness in clinical Stage I melanoma. Day CL Jr, Lew RA, Mihm MC Jr, Harris MN, Kopf AW, Sober AJ, Fitzpatrick TB. PMID: 7290125 [PubMed - indexed for... more
    1. N Engl J Med. 1981 Nov 5;305(19):1155. The natural break points for primary-tumor thickness in clinical Stage I melanoma. Day CL Jr, Lew RA, Mihm MC Jr, Harris MN, Kopf AW, Sober AJ, Fitzpatrick TB. PMID: 7290125 [PubMed - indexed for MEDLINE]. ...
    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.
    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.
    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.

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