Biomedical subjects
M McCabe
Publications and source records attributed to M McCabe.
Measuring the incremental cost of clinical cancer research.
PURPOSE: To summarize evidence on the costs of treating patients in clinical trials and to describe the Cost of Cancer Treatment Study, an ongoing effort to produce generalizable estimates of the incremental costs of government-sponsored cancer trials. METHODS: A retrospective study of costs will be conducted with 1,500 cancer patients recruited from a randomly selected sample of institutions in the United States. Patients accrued to either phase II or phase III National Cancer Institute-sponsored clinical trials during a 15-month period will be asked to participate in a study of their health care utilization (n = 750). Costs will be measured approximately 1 year after their trial enrollment from a combination of billing records, medical records, and an in-person survey questionnaire. Similar data will be collected for a comparable group of cancer patients not in trials (n = 750) to provide an estimate of the incremental cost. RESULTS: Evidence suggests insurers limit access to trials because of cost concerns. Public and private efforts are underway to change these policies, but their permanent status is unclear. Previous studies found that treatment costs in clinical trials are similar to costs of standard therapy. However, it is difficult to generalize from these studies because of the unique practice settings, insufficient sample sizes, and the exclusion of potentially important costs. CONCLUSION: Denials of coverage for treatment in a clinical trial limit patient access to trials and could impede clinical research. Preliminary estimates suggest changes to these policies would not be expensive, but these results are not generalizable. The Cost of Cancer Treatment Study is an ongoing effort to provide generalizable estimates of the incremental treatment cost of phase II and phase III cancer trials. The results should be of great interest to insurers and the research community as they consider permanent ways to finance cancer trials.
Incidence of childhood fractures in affluent and deprived areas: population based study.
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Intercomparison of five PM10 monitoring devices and the implications for exposure measurement in epidemiological research.
Five different instruments for the determination of the mass concentration of PM10 in air were compared side-by-side for up to 33 days in an undisturbed indoor environment: a tripod mounted BGI Inc. PQ100 gravimetric sampler with a US EPA certified Graseby Andersen PM10 inlet; an Airmetrics Minivol static gravimetric sampler; a Casella cyclone gravimetric personal sampler; an Institute of Occupational Medicine gravimetric PM10 personal sampler; and two TSI Inc. Dustrak real-time optical scattering personal samplers. For 24 h sampling of ambient PM10 concentrations around 10 microg m(-3), the estimated measurement uncertainty for the two gravimetric personal samplers was larger (approximately +/- 20%) compared with estimated measurement uncertainty for the PQ100/Graseby Andersen sampler (< +/- 5%). Measurement uncertainty for the Dustraks was lower (approximately +/- 15% on average) but calibration of the optical response against a reference PM10 method is essential since the Dustraks systematically over-read PM10 determined gravimetrically by a factor approximately 2.2. However, once calibrated, the Dustrak devices demonstrated excellent functionality in terms of ease of portability and real-time data acquisition. Estimated measurement uncertainty for PM10 concentrations determined with the Minivol were +/- 5%. The Minivol data correlated well with PQ100/Graseby Andersen data (r= 0.97, n = 18) but were, on average, 23% greater. The reason for the systematic discrepancy could not be traced. Intercomparison experiments such as these are essential for assessing measurement error and revealing systematic bias. Application of two Dustraks demonstrated the spatial and temporal variability of exposure to PM10 in different walking and transport microenvironments in the city of Edinburgh, UK. For example, very large exposures to PM10 were identified for the lower deck of a double-decker tour bus compared with the open upper deck of the same vehicle. The variability observed emphasises the need to determine truly personal exposure profiles of PM10 for quantifying exposure response relationships for epidemiological studies.
Investigation of an acute chemical incident: exposure to fluorinated hydrocarbons.
OBJECTIVES: To assess whether attendance at the site after an incident in a sewer was associated with symptoms in emergency personnel and whether the prevalence of symptoms was associated with estimated levels of exposure to any chemical hazard. METHODS: Symptoms experienced by people attending an incident involving two dead sewer workers suggested the presence of a chemical hazard, before environmental sampling confirmed any toxic agent. Self reported symptoms, estimated exposures, and biomarkers of exposure for likely agents from all 254 people who attended the incident and a referent occupational group matching the 83 emergency personnel who went to the Accident and Emergency department (A and E) in the first 48 hours were recorded. The prevalence of symptoms and concentrations of creatine phosphokinase in serum of the 83 early patients at A and E were compared with their referent occupational group. In all workers who attended the incident, the trends in symptom prevalences and concentrations of creatine phosphokinase in serum were examined by distance from the site and predefined exposure category. RESULTS: Among all workers who attended the incident, symptoms of shortness of breath and sore throat were significantly associated with indirect estimates of exposure but not associated with concentrations of creatine phosphokinase. Freon was detected in two blood samples. The early patients at A and E reported more symptoms than their matched reference group and their median concentrations of creatine phosphokinase were higher. CONCLUSIONS: The association between symptoms and concentrations of creatine phosphokinase with attendance at the site indicated the presence of a continuing hazard at the site and led to extra precautions being taken. Comparison values from the referent occupational group prevented unnecessary medical follow up.
Sharing data to prevent injuries.
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Using disease-state management as the key to promoting employer sponsorship of medical nutrition therapy (continuing education credit).
The purpose of this project was to design, implement, and improve a nationwide medical nutrition therapy (MNT) intervention program for nutritionally at-risk employees and their dependents and retirees (hereinafter referred to as clients) with a Fortune 100 company (Texas Instruments, Dallas, Tex) with a dispersed population of 80,000. Preferred Nutrition Therapists (PNT), a network of registered dietitians, with the assistance of the Texas Instruments Health Promotion and Benefits Department, identified International Classification of Diseases, 9th ed (ICD-9), codes for which MNT intervention was appropriate. PNT then negotiated a contract with the Texas Instruments Health Promotion and Benefits Department and implemented clients' self-referral process. The main challenge was to promote utilization of a new service from an outside vendor (PNT) and to measure outcomes in meaningful ways. The goal was to use MNT as a tool to prevent the progression of clients' diseases to states that require more costly treatments. PNT used a continuous quality improvement process to refine the system and improve information gathering and reporting, by providing quarterly reports to the Health Promotion and Benefits Department. These reports summarized the outcomes for all clients seen at least 3 times during the quarter. The cost was less than $0.35 per member per month (less than the employer spent on advertising the program), and 0.5% of the population requested MNT during the first year of implementation (about what was expected for a new carveout benefit).
Children's fractures: a population based study.
OBJECTIVE: To measure the incidence of childhood fractures in a defined population. SETTING: Accident and emergency (A&E) departments covering the Swansea and Neath Port Talbot areas of South Wales in 1996. METHODS: Linkage of data from A&E departments with population data to produce fracture incidence rates by anatomical site and cause in children aged 0-14 years. RESULTS: During 1996, 2463 new fractures occurred in 2399 residents yielding a fracture rate of 36.1/1000 children. Fractures were more common in boys than girls and increased with age in both groups. Sports and leisure activities accounted for 36% of fractures, assaults for 3.5%, and road traffic accidents 1.4%. Fractures of the radius/ulna were most frequent (36%). CONCLUSIONS: The fracture rate in South Wales children is twice the rate reported in previous studies. Further research is required to elucidate the reasons behind this high rate. Many fractures could be prevented by the use of safer surfaces in school playgrounds, and wrist protection in in-line skaters and possibly in soccer players.
Analysis of risk factors for the development of bronchiolitis obliterans syndrome.
Chronic rejection after lung transplantation, manifesting as bronchiolitis obliterans syndrome (BOS), has become the dominant challenge to long-term patient and graft survival. In order to elucidate risk factors for development of BOS we utilized the 1995 revision of the working formulation for the classification of lung allograft rejection (), and devised a quantitative method to retrospectively study lung transplant biopsies from all patients who survived at least 90 d. All transbronchial biopsies were regraded 0 to 4 for acute perivascular rejection and lymphocytic bronchitis/bronchiolitis (LBB), and the grades were totaled over a period of time to give two scores, respectively, for each patient. Also examined were timing of acute rejection and LBB episodes and decreased immunosuppression defined as two or more cyclosporine A levels < 200 ng/ml. Sixty-six patients with BOS and 68 with no BOS (NBOS) satisfied our criteria for inclusion in the study. Demographics including age, sex, and primary diagnoses were similar. The mean perivascular score for BOS was 6.2 over a mean follow-up of 822 d (range, 113 to 2,146) compared with 3.2 for NBOS over 550 d (range, 97 to 1,734) mean follow-up. Airway scores were 5.3 and 1.7, respectively, for the same follow-up periods. There was no correlation between length of follow-up and rejection or LBB scores, although mean length of follow-up for the two groups was significantly different. Late acute rejection and LBB were significantly associated with BOS as was decreased immunosuppression. In addition to perivascular rejection, LBB, late acute rejection, and decreased immunosuppression are significant risk factors for the development of BOS. Analysis of the current data leads us to believe that LBB, in the absence of infection, is in fact a manifestation of acute rejection, with similar implications for graft function as acute perivascular rejection.
Legibility of doctors' handwriting: quantitative comparative study.
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Accident and emergency broadsheet: Undergraduate accident and emergency medicine education broadsheet.
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Clinical trials referral resource. Integrating economic analysis into cooperative group trials.
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Sexual and emotional variables influencing sexual response to erotica.
This study was designed to evaluate the relative contribution of attention and emotional responses to the sexual response to erotica. Self reported levels of sexual arousal, attention, and emotional responses were measured after 20 men and 20 women viewed a series of erotic film segments. Men and women reported greater sexual arousal to erotica when they became absorbed in the activities portrayed in the film and when they experienced the erotic encounters as appetitive, than when they were distracted and perceived the encounters as aversive. Subjective sexual arousal also correlated positively with the degree to which subjects experienced entertainment and curiousity to the erotic film segments, but negatively with boredom. The level of sexual arousal reported by subjects did not correlate significantly with trait measures of absorption (as indexed by the Tellegen Absorption Scale) and vividness of imagery (as assessed by the Betts Questionnaire upon Mental Imagery). The multidimensional nature of the sexual response was demonstrated by the fact that the magnitude of subjective sexual arousal was predicted by the separate groupings of state assessed attentional and emotional variables, trait indexed absorption and appetitive feelings, and demographic information. These findings applied to both men and women, with the exception that men experienced greater sexual arousal than women, and women reported more disgust to the stimulus materials. Future directions for studying the basis for differences in sexual arousal between men and women are outlined, with an emphasis on a psychophysiological exploration of these phenomena.
Malignant chondroid syringoma presenting as multiple pulmonary nodules.
Malignant chondroid syringoma, a very rare tumour, presenting with multiple pulmonary metastases in a 50 year old woman is described. Initial diagnostic confusion with pulmonary hamartoma occurred due to histopathological similarities. However, re-examination of a skin biopsy specimen taken 17 years previously from a hand lesion yielded the necessary information to identify the pulmonary lesions definitively as metastases from the original skin lesion. The features of this very rare indolent tumour are described.
Electroejaculation versus vibratory stimulation in spinal cord injured men: sperm quality and patient preference.
PURPOSE: We compared semen quality and patient preference between penile vibratory stimulation and electroejaculation in spinal cord injured men. MATERIALS AND METHODS: We treated 11 spinal cord injured men with penile vibratory stimulation and electroejaculation in random order. End points examined were semen analysis, sperm functional assessment, and patient pain scores (1 to 10) and preferred procedure. Differences between the procedures were determined with the paired Student t test. RESULTS: There was no difference in antegrade sperm count but penile vibratory stimulation specimens had greater motility (26.0 versus 10.7%), viability (25.2 versus 9.7%) and motile sperm count (185.0 x 10(6) versus 97.0 x 10(6)). The retrograde sperm count was greater (but not significant) in electroejaculation patients. The total (antegrade plus retrograde) and motile sperm counts were not different. There was no difference in immunobead test (all negative), cervical mucus penetration or sperm penetration assay, although the percent hamster egg penetration approached significance (53.7% for penile vibratory stimulation versus 22.1% for electroejaculation, p = 0.06). There was no difference in the peak blood pressures and no complications were noted. Pain scores were significantly greater for electroejaculation compared to penile vibratory stimulation (5.2 versus 1.7, respectively). All patients preferred penile vibratory stimulation. CONCLUSIONS: There was a slight advantage in sperm quality and a high patient preference in favor of penile vibratory stimulation. Penile vibratory stimulation should be attempted first to induce ejaculation in spinal cord injured men, with electroejaculation reserved for failures.
Epidermal growth factor and platelet-derived growth factor-BB induce a stable increase in the activity of low density lipoprotein receptor-related protein in vascular smooth muscle cells by altering receptor distribution and recycling.
Low density lipoprotein receptor-related protein (LRP) is a multifunctional receptor, expressed by vascular smooth muscle cells (VSMCs) in normal arteries and in atherosclerotic lesions. In this investigation, we demonstrate a novel mechanism for the regulation of LRP activity in cultured rat aortic VSMCs. Cells that were treated with platelet-derived growth factor-BB (PDGF-BB) or epidermal growth factor (EGF) for 24 h bound increased amounts of the LRP ligand, activated alpha2-macroglobulin (alpha2M), at 4 degrees C. The Bmax for activated alpha2M was increased from 56 +/- 5 to 178 +/- 24 and 143 +/- 11 fmol/mg cell protein by PDGF-BB and EGF, respectively, while the KD was unchanged. Northern and Western blot analyses demonstrated that neither PDGF-BB nor EGF increase LRP mRNA or protein levels. Instead, LRP was redistributed to the cell surface and remained localized primarily in coated pits, as determined by surface protein biotinylation, affinity labeling, and immunoelectron microscopy studies. The increase in cell-surface LRP was partially explained by a 50% decrease in receptor endocytosis rate; however, at 37 degrees C, PDGF-BB- and EGF-treated VSMCs still bound/internalized increased amounts of activated alpha2M and subsequently released increased amounts of trichloroacetic acid-soluble radioactivity. The cytokine-induced shifts in LRP subcellular distribution were stable when VSMCs were challenged with a saturating concentration of ligand and then incubated, in the absence of cytokine, for 2.5 h at 37 degrees C. Regulation of LRP distribution and activity may be an important aspect of the VSMC response to the atherogenic cytokines, PDGF-BB and EGF.
Abnormal lymphocyte surface antigen expression in peripheral blood of a Kuwaiti population.
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Fractures caused by bicycling.
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