Breast Density Legislation: Discussion of Patient Utilization and Subsequent Direct Financial Ramifications for Insurance Providers.

Now that New Jersey has become the 14th state in the United States to enact legislation regarding dense breast screening, its patients are eligible to receive screening breast sonography coverage from their insurance carriers. This law is intended to improve breast cancer detection in patients with dense breasts and create awareness of unique issues that come with dense breast tissue, while reinforcing already present efforts to reduce the incidence of and morbidity related to the diagnosis of breast cancer. The aim of this study was to examine data from months preceding the effective date of this legislation in a community hospital setting and compare these data with data from months immediately after, and 6 months after, its enactment to present patient participation data and estimate the legislation's direct financial ramifications. Detractors of this type of legislation worry about overburdening the health care system with an influx of patients. Although there is a lack of present studies confirming this suspicion in other states with dense breast legislation, this study confirms a large increase in patient utilization after enactment, showing a minimum relative increase of 176.90% and a maximum relative increase of 335.56% in patient utilization of screening breast sonography. The investigators further include an estimation of an increased direct cost for insurers of $4,910,899.18 to $9,848,897.96 for a given month.

Densitometric HPTLC analysis of 8-gingerol in Zingiber officinale extract and ginger-containing dietary supplements, teas and commercial creams.

OBJECTIVE: To develop and validate a simple, accurate HPTLC method for the analysis of 8-gingerol and to determine the quantity of 8-gingerol in Zingiber officinale extract and ginger-containing dietary supplements, teas and commercial creams. METHODS: The analysis was performed on 10×20 cm aluminium-backed plates coated with 0.2 mm layers of silica gel 60 F254 (E-Merck, Germany) with n-hexane: ethyl acetate 60: 40 (v/v) as mobile phase. Camag TLC Scanner III was used for the UV densitometric scanning at 569. RESULTS: This system was found to give a compact spot of 8-gingerol at retention factor (Rf) value of (0.39±0.04) and linearity was found in the ranges 50-500 ng/spot (r (2)=0.9987). Limit of detection (12.76 ng/spot), limit of quantification (26.32 ng/spot), accuracy (less than 2 %) and recovery (ranging from 98.22-99.20) were found satisfactory. CONCLUSIONS: The HPTLC method developed for quantification of 8-gingerol was found to be simple, accurate, reproducible, sensitive and is applicable to the analysis of 8-gingerol in Zingiber officinale extract and ginger-containing dietary supplements, teas and commercial creams.

Densidade mineral óssea de mulheres na pós-menopausa em diferentes sítios e avaliação do risco de fratura / Bone mineral density in postmenopausal women in different sites and fracture risk assessment

O rápido envelhecimento da população brasileira cria um contexto de assistência prolongada e específica a morbidades que tendem a ampliar a duração do tratamento, as incapacidades dos indivíduos, os gastos com exames complementares, internações hospitalares e medicação. Dentro desse contexto, a osteoporose, doença intimamente relacionada com o envelhecimento, pode ter um aumento considerável nos próximos anos. Conhecer quem são os indivíduos em risco de desenvolver a doença é fundamental, uma vez que a fratura, sua mais importante conseqüência clínica, representa gastos elevados com serviços de saúde e está associada à alta taxa de morbidade e mortalidade. O exame indicado pela Organização Mundial da Saúde (OMS) como padrão-ouro para o diagnóstico da osteoporose é o exame de densitometria óssea (DXA), Devidos aos custos e acesso restrito e assim, selecionar candidatos ao exame é uma questão com importantes implicações clínicas e sócioeconômicas. O objetivo deste estudo foi avaliar a validade diagnóstica da radiografia panorâmica para identificação de mulheres na pós-menopausa com baixa massa óssea. Foram utilizados: questionário baseado nos fatores clínicos de risco para osteoporose, exame de densitometria óssea (fêmur, coluna e antebraço), radiografia panorâmica digital e o São Paulo Osteoporosis Risk Index (SAPORI). O estudo é do tipo observacional transversal. Os valores de sensibilidade e especificidade, valor preditivo positivo e negativo foram calculados. A amostra foi constituída por 88 mulheres na pós-menopausa com média de idade de 61 anos. A baixa massa óssea no quadril foi observada em 62 mulheres (70,5 por cento), na coluna em 61(69,3 por cento), no antebraço em 78 (88,6 por cento) e 52 (59,1 por cento) na mandíbula. Fratura após os 50 anos de idade foi observada em 17 mulheres (19,3 por cemto) e 37 (42 por cento) relataram ocorrência de queda nos últimos 12 meses. A radiografia panorâmica é um instrumento válido para a identificação de mulheres na pósmenopausa com baixa densidade mineral óssea.

Quantitative determination of oxybutynin hydrochloride by spectrophotometry, chemometry and HPTLC in presence of its degradation product and additives in different pharmaceutical dosage forms.

Simple, accurate, sensitive and validated UV spectrophotometric, chemometric and HPTLC-densitometric methods were developed for determination of oxybutynin hydrochloride (OX) in presence of its degradation product and additives in its pharmaceutical formulations. Method A is the first derivative of ratio spectra (DD(1)) which allows the determination of OX in presence of its degradate in pure form and tablets by measuring the peaks amplitude at 216 nm. Method B and C are principal component regression (PCR) and partial least-squares (PLS) for determination of OX in presence of its degradate in pure form, tablets and syrup. While, the developed high performance thin layer chromatography HPTLC-densitometric method was based on the separation of OX from its degradation product, methylparaben and propylparaben followed by densitometric measurement at 220 nm which allows the determination of OX in pure form, tablets and syrup. The separation was achieved using HPTLC silica gel F(254) plates and chloroform:methanol:ammonia solution:triethylamine (100:3:0.5:0.2, v/v/v/v) as the developing system. The accuracy, precision and linearity ranges of the developed methods were determined. The results obtained were statistically compared with each other and to that of a reported HPLC method, and there was no significant difference between the proposed methods and the reported method regarding both accuracy and precision.

Selective densitometric determination of four alpha-aminocephalosporins using ninhydrin reagent.

A simple, selective, and precise densitometric method for analysis of four alpha-aminocephalosporins, namely cefaclor monohydrate, cefadroxil monohydrate, cefalexin anhydrous, and cefradine anhydrous, both in bulk drugs and in formulations was developed and validated. The method employed thin-layer chromatography (TLC) aluminium sheets precoated with silica gel G 60 F(254) as the stationary phase. The solvent system consists of ethyl acetate-methanol-water with different ratios for all studied drugs (R(f) values of 0.40-0.60). The separated spots were visualized as blue to violet color after spraying with ninhydrin reagent. The linear regression analysis data for the calibration plots of all studied drugs produced a good linear relationship with correlation coefficients ranging from 0.9990 to 0.9996 and coefficients of determination ranging from 0.9986 to 0.9992 over the concentration range 2-10 microg/spot. The limits of detection and quantitation for all studied drugs ranged from 0.09 to 0.23 and from 0.27 to 0.84 microg/spot, respectively. The developed method was applied successfully for the determination of the studied drugs in their pharmaceutical dosage forms with good precision and accuracy. Also, the method can be employed as a promising stability-indicating assay.

Quantitative ultrasound for the detection and management of osteoporosis.

Quantitative ultrasound (QUS) appears to be developing into an acceptable, low-cost and readily-accessible alternative to dual X-ray absorptiometry (DXA) measurements of bone mineral density (BMD) in the detection and management of osteoporosis. Perhaps the major difficulty with their widespread use is that many different QUS devices exist that differ substantially from each other, in terms of the parameters they measure and the strength of empirical evidence supporting their use. But another problem is that virtually no data exist outside of Caucasian or Asian populations. In general, heel QUS appears to be most tested and most effective. Some, but not all heel QUS devices are effective assessing fracture risk in some, but not all populations, the evidence being strongest for Caucasian females > 55 years old, though some evidence exists for Asian females > 55 and for Caucasian and Asian males > 70. Certain devices may allow to estimate the likelihood of osteoporosis, but very limited evidence exists supporting QUS use during the initiation or monitoring of osteoporosis treatment. Likely, QUS is most effective when combined with an assessment of clinical risk factors (CRF); with DXA reserved for individuals who are not identified as either high or low risk using QUS and CRF. However, monitoring and maintenance of test and instrument accuracy, precision and reproducibility are essential if QUS devices are to be used in clinical practice; and further scientific research in non-Caucasian, non-Asian populations clearly is compulsory to validate this tool for more widespread use.

Using the osteoporosis self-assessment tool for referring older men for bone densitometry: a decision analysis.

OBJECTIVES: To compare health benefits and costs associated with performing bone densitometry for all men with those of risk-stratifying using the Osteoporosis Self-Assessment Tool (OST) and performing bone densitometry only for a high-risk group. DESIGN: A decision analytical model was developed using a Markov process. Three strategies were compared: no bone densitometry, selective bone densitometry using the OST, and universal bone densitometry. Data sources were U.S. epidemiological studies and healthcare cost figures. SETTING: Hypothetical cohort. PARTICIPANTS: Community-dwelling 70-year-old U.S. white men with no history of clinical osteoporotic fractures. INTERVENTION: Five years of alendronate therapy for those diagnosed with osteoporosis. MEASUREMENTS: Life years, quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratios. RESULTS: Selective bone densitometry using the OST would cost $100,700 per additional life year gained compared to the no bone densitometry strategy. Universal bone densitometry would cost $483,500 for additional life year gained compared to selective bone densitometry. When quality of life was considered, both strategies became approximately 15% more cost-effective. Compared with the no bone densitometry strategy, selective bone densitometry would be cost saving for those aged 84 and older, with a reduction of alendronate price (< or =$110 per year), or with a higher efficacy of alendronate (a relative risk reduction of nonvertebral fracture > or =82%). CONCLUSION: Universal bone densitometry for 70-year-old men is not a good investment for society. It is reasonably cost-effective to risk-stratify with the OST, perform bone densitometry only for high-risk group, and then give men diagnosed with osteoporosis generic alendronate.

Quantitative ultrasound for the detection and management of osteoporosis: [review] / Ultrasonido cuantitativo para la detección y manejo de osteoporosis: [revisión]

Quantitative ultrasound (QUS) appears to be developing into an acceptable, low-cost and readily-accessible alternative to dual X-ray absorptiometry (DXA) measurements of bone mineral density (BMD) in the detection and management of osteoporosis. Perhaps the major difficulty with their widespread use is that many different QUS devices exist that differ substantially from each other, in terms of the parameters they measure and the strength of empirical evidence supporting their use. But another problem is that virtually no data exist outside of Caucasian or Asian populations. In general, heel QUS appears to be most tested and most effective. Some, but not all heel QUS devices are effective assessing fracture risk in some, but not all populations, the evidence being strongest for Caucasian females > 55 years old, though some evidence exists for Asian females > 55 and for Caucasian and Asian males > 70. Certain devices may allow to estimate the likelihood of osteoporosis, but very limited evidence exists supporting QUS use during the initiation or monitoring of osteoporosis treatment. Likely, QUS is most effective when combined with an assessment of clinical risk factors (CRF); with DXA reserved for individuals who are not identified as either high or low risk using QUS and CRF. However, monitoring and maintenance of test and instrument accuracy, precision and reproducibility are essential if QUS devices are to be used in clinical practice; and further scientific research in non-Caucasian, non-Asian populations clearly is compulsory to validate this tool for more widespread use.

El ultrasonido cuantitativo (QUS) es una alternativa para la detección y manejo de la osteoporosis de bajo costo y uso práctico, si se compara con las densitometrías de rayos X de doble haz de baja energía (DXA) que determinan densidad mineral ósea (BMD). La mayor dificultad para el uso generalizado del QUS por un lado es que existen muchos instrumentos que son significativamente diferentes uno del otro y por otro en la calidad de la evidencia en que se justifica su empleo, que generalmente es insuficiente y/o poco sistematizada. Otro problema importante del QUS, es que prácticamente no existe información que no sea la generada en poblaciones asiáticas o caucásicas. En general, los estudios de calcáneo realizados con QUS son los más utilizados y mejor validados para evaluar el riesgo de fracturas en algunas poblaciones. La evidencia más grande de su efectividad se conoce para las mujeres caucásicas y asiáticas mayores de 55 años e incluso para los hombres asiáticos mayores de 70 años. Varios instrumentos cuentan con buen sustento científico, que los vuelve confiables para establecer un pronóstico preciso e identificar el riesgo individual de sufrir fracturas por osteoporosis, sin embargo, existe poca evidencia que respalde su uso para iniciar y monitorear el resultado del tratamiento de la osteoporosis. El QUS mejora su efectividad diagnóstica cuando se combina con los resultados de un cuestionario que identifica riesgos clínicos. En un escenario ideal, el DXA se debe reservar solo para aquellos individuos que no puedan ser identificados de manera confiable usando QUS y el cuestionario de riesgos clínicos. Si se quiere aceptar a los instrumentos QUS en la práctica clínica, para el monitoreo es indispensable asegurar y mantener la exactitud, precisión y reproducibilidad de los instrumentos y de los técnicos que los utilizan. Se requieren más estudios científicos de poblaciones no caucásicas o asiáticas para validar el uso generalizado del QUS.

Economical choices in setting up a diagnostic myeloma laboratory.

In setting up a diagnostic myeloma laboratory the popular, highly automated and otherwise excellent choices of equipment and laboratory practices, so exorbitantly raise costs that the sustainability, even in large government hospitals in third world countries may become difficult. Based on our experience in a regional cancer center in India, we offer here, guidelines for carrying out high resolution electrophoresis, densitometry, immunofixation and urine concentration. We show that by simply employing well established techniques and doing them properly, one can get results of excellent quality at minimum cost and minimum dependence on costly imports.

Screening for childhood anaemia using copper sulphate densitometry.

OBJECTIVE: To evaluate copper sulphate densitometry to screen for childhood anaemia in a primary care setting, with a view to identifying children requiring definitive diagnostic testing and treatment. DESIGN: A cross-sectional screening study. Results of densitometry with a copper sulphate solution of specific gravity (SG) 1.048, corresponding to a haemoglobin (Hb) concentration of 10 g/dl, were compared with laboratory Hb determination. SETTING: Outpatient department of Pretoria Academic Hospital (73 children) and a local crèche (27 children). SUBJECTS: One hundred consecutive children, aged between 6 months and 6 years, with informed written consent by parents. OUTCOME MEASURE(S): Accuracy of copper sulphate densitometry in screening for Hb concentration below 10 g/dl in terms of sensitivity, specificity, positive and negative predictive values, as well as likelihood ratio. RESULTS: The prevalence of anaemia (Hb < 10 g/dl) was 17% (95% confidence interval (CI) 10.2; 25.8). Copper sulphate densitometry had a sensitivity of 88.2% (95% CI 62.3; 97.9), a specificity of 89.2% (95% CI 79.9; 94.6), a positive predictive value of 62.5% (95% CI 40.8; 80.5) and a negative predictive value of 97.4% (95% CI 90.0; 99.5) in screening for anaemia. The likelihood ratio of a positive screening test was 8.17. CONCLUSIONS: Copper sulphate densitometry was accurate in screening for childhood anaemia.

Medicare program; Medicare coverage of and payment for bone mass measurements--HCFA. Interim final rule with comment period.

This interim final rule with comment period provides for uniform coverage of, and payment for, bone mass measurements for certain Medicare beneficiaries for services furnished on or after July 1, 1998. It implements provisions in section 4106(a) of the Balanced Budget Act of 1997.

Bone density measurement--a systematic review. A report from SBU, the Swedish Council on Technology Assessment in Health Care.

Because a reduction in bone density often correlates to an increased risk of fracture, bone density is usually measured in an attempt to establish the risk of fracture. The results from bone density measurement are intended to provide a potential basis for treating osteoporosis. When assessing the value of bone density measurement, the key issues concern the reliability of the various methods (i.e., how accurately they reflect bone density) and whether bone density treatment can actually prevent fracture. OSTEOPOROSIS: Humans begin to lose bone tissue as they become older. In most cases, this process is slow and gradual. Bone tissue begins to disappear when people are aged between 30 and 40 years and continues throughout life. However, bone loss varies greatly among individuals, and some elderly people show no sign of bone loss. Several factors influence both the loss of bone mass as people age and the formation of bone mass in the growing individual. The single most important factor associated with reduced bone mass is the loss of the female sex hormone (oestrogen). Tobacco smoking, lack of exercise, and low calcium levels in the diet also reduce bone density. Reduced bone density may lead to osteoporosis, which increases the risk of fracture, often affecting the vertebrae, hips and wrists. The most common direct cause of fracture, mainly among the elderly, involves falling or stumbling. Contributing factors here include diseases or medications that affect the sight, muscle strength, and balance. Osteoporosis is one of many risk factors for fractures resulting from falls. Fracture is a large and growing health problem. Each year, approximately 60,000 people in Sweden suffer some type of fracture. With an increasing percentage of elderly people in the Swedish population, it is estimated that every second woman over 50 years of age will experience fracture at some time during their remaining life. The risk in men is lower. It is essential to prevent, as far as possible, the onset of osteoporosis and other risk factors for fracture. Preventive approaches include, increased physical activity during youth when people develop their bone mass, sufficient intake of calcium in the diet among the young and old alike, and smoking cessation (or preventing people from starting to smoke). It is particularly important to treat osteoporosis effectively, or prevent osteoporosis from developing into a serious condition. This requires further research into strategies for treating osteoporosis. The various methods for measuring bone density represent an important component in such research. MEASURING BONE DENSITY: Bone density may be measured either to establish a diagnosis or to monitor changes, e.g. follow-up treatment for osteoporosis. Bone density can be estimated roughly by simply measuring height, weight, and age, but this approach has limited value for establishing the level of bone density in individuals. To a certain extent, x-ray examination can also be used to estimate the level of bone density. Special methods have been developed in recent decades for measuring bone density, and technologies for this purpose have become more widely available since the 1980s. The new methods for bone density measurement are based on either the energy/methodology used in ultrasound and magnetic resonance imaging (MRI), or on x-rays. Some methods are designed for measuring only the forearm, hip, lumbar spine, or heel bone (calcaneus), while others measure several sites in the body simultaneously. Most methods demonstrate good precision (i.e. repeated measurements yield the same results). However, to establish the bone density level reliably, methods must also be highly accurate (i.e. the values obtained by measurement must coincide with the individual's actual bone density). The accuracy of current technologies is substantially lower than their precision, so further research, technical development, and experience are required before the methods can be i

Bone densitometry: patients with asymptomatic primary hyperparathyroidism part I. Technical report.

Many studies document bone loss at diagnosis in patients with PHPT (including mild PHPT) that is greater than would be expected in comparable persons without this condition. However, there is no general agreement regarding the severity of bone mass loss in these patients and the rate at which it progresses. A few studies suggest that such accelerated osteoporosis may be self-limited, with patients showing no further decline in BMD after diagnosis. There is insufficient evidence to conclude that PTH-related bone loss is associated with an increased risk of fracture. The few studies that have evaluated the risk of fracture in these patients are conflicting. Some evidence also suggest that, like bone loss in these patients, fracture risk may change during the course of the disease. One study found that patients with PHPT (including those with mild hypercalcemia) were more likely than matched controls to have a history of fractures prior to diagnosis, but that both groups had similar rates of fractures during followup. Moreover, the studies of fractures suffer from several limitations, such as nonrandomization of patients, different definitions of vertebral fractures, small study populations, and short followup times. There is also insufficient evidence to determine the effect of parathyroidectomy on the incidence of fractures in patients with mild PHPT, partly because the natural history of this condition is incompletely understood. Although studies demonstrate that patients with PHPT gain bone mass following parathyroidectomy, the bone reparation is incomplete and bone mass density remains below normal, even though the hyperparathyroidism is cured. Currently, decisions to perform parathyroidectomy are based on signs and symptoms of bone disease, metabolically active renal stones, decreased renal function, fatigue and/or depression, and high levels of serum calcium. Although the use of bone mass measurements has been advocated to aid clinical decisions regarding the risks and benefits of surgery, specific bone changes that indicate the need for parathyroidectomy have not been clearly established. There are virtually no prospective data that evaluate decisions to operate based upon bone mass measurements nor randomized clinical trials comparing the outcome of surgically treated patients with those who have not had surgery. Based on the literature, bone mass measurements cannot predict who among asymptomatic patients will require parathyroidectomy. There is some evidence that nonsurgically treated patients and those who remained hypercalcemic after unsuccessful surgery lost bone at the same percentage rate as normal control subjects.

Monitoring of monoclonal gammopathies: rational use of densitometry and rate nephelometry.

The follow-up of patients with monoclonal gammopathies at our institution includes serial serum protein electrophoresis (SPE) with densitometry and IgG, IgA, and IgM quantitative immunoglobulin (QIG) determinations by rate nephelometry. This retrospective audit compares monoclonal protein concentration as estimated by SPE versus QIG in 456 serial serum specimens from 105 patients to determine whether any of the tests provide redundant information. A comparison of the methods demonstrated good correlation between SPE (x-axis) and QIG (y-axis) quantitation for each immunoglobulin class: IgG had a slope of 1.45 and an intercept of 1.60 (Sy/x = 7.46, r = 0.96, n = 250); IgA had a slope of 1.30 and an intercept of -1.37 (Sy/x = 6.85, r = 0.96, n = 78); and IgM had a slope of 1.95 and an intercept of 2.06 (Sy/x = 5.16, r = 0.98, n = 128). The data for individual patients showed similar good correlations. Exceptions included IgA peaks "buried" in the beta region of the SPE (resulting in invalid SPE estimates of monoclonal protein concentration), and IgG peaks of less than 10 g/L (when background polyclonal IgG immunoglobulin skews the QIG estimate of monoclonal protein concentration). An algorithm is proposed whereby monoclonal protein concentration is measured by the specific QIG (i.e., IgG, IgA, or IgM) determination for the routine monitoring of patients, except for those with IgG peaks of less than 10 g/L that are followed by SPE.

A laser densitometer for selective spot analysis on dot blots and two-dimensional gel autoradiograms.

We describe an inexpensive densitometer, employing a small HeNe laser and an IBM-compatible personal computer that performs accurate measurements of selected spots on two-dimensional gel autoradiograms or chromatograms with an accuracy and a sensitivity equal or superior to those of many commercial instruments. Our open-table design allows the operator to visually monitor the scanning process in room lighting, and provides great flexibility in both the size and the nature of items to be scanned. The instrument has two moving parts (a prism and a small motor). A commercially available software package (ASYST) acquires digital data, graphs the data on the TV monitor, converts the data to optical density or to radioactive incorporation (cpm), subtracts background, integrates peak areas, and stores data on disk. The total time for these operations is 20-30 s per spot. The instrument has a dynamic range of 0.25 to 3.0 OD units and can measure a 10,000-fold range of 14C or 35S isotope concentrations on autoradiograms. The complete device can be assembled with a hobbyist's knowledge of electronics, moderate programming abilities (no machine language required), and a cost of less than $3000, not including the IBM PC.