Absence of clinical benefit of FDG PET-CT in staging T1 part-solid lung adenocarcinoma.

AIM: To assess the rates of nodal and metastatic disease and change in management when staging part-solid T1 lung adenocarcinomas using integrated 2-[18F]-fluoro-2-deoxy-d-glucose (FDG) positron-emission tomography (PET)-computed tomography (CT) in a UK population. MATERIALS AND METHODS: This was a retrospective review of PET-CT examinations performed to stage radiologically suspected T1 part-solid lung adenocarcinoma (n=58) from two different centres. Rates of detection of nodal and metastatic disease, change in management, and final patient outcome were recorded. RESULTS: PET-CT changed the stage in one patient from N0 to N1. It did not change final management in any patient. CONCLUSIONS: In this UK population, PET-CT had minimal additional diagnostic benefit in staging patients with T1 part-solid lung adenocarcinoma. Especially given its cost, the inclusion of PET-CT for this indication in guidelines should be reviewed.

Improving diagnostic performance of 18F-FDG-PET/CT for assessment of regional nodal involvement in non-small cell lung cancer.

AIM: To assess the diagnostic performance of combined 2-[18F]-fluoro-2-deoxy-d-glucose (18F-FDG) positron-emission tomography (PET)/computed tomography (CT) mediastinal blood pool (MBP) activity cut-off for staging nodal involvement, and to examine other variables that may improve the diagnostic performance of PET/CT in non-small cell lung cancer (NSCLC). MATERIALS AND METHODS: All patients diagnosed with NSCLC who underwent endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and 18F-FDG-PET/CT between June 2016 and August 2018 were included. Nodal station and nodal staging-based analyses were performed, comparing the MBP cut-off and five other PET/CT parameters (node maximum standardised uptake value [SUVmax], node/MBP SUVmax ratio, node/tumour SUVmax ratio, node short axis diameter, and node SUVmax/node short axis diameter ratio) with histopathology results. The optimal cut-off value for each PET/CT parameter was determined using receiver operating characteristic curve analysis. RESULTS: One hundred and thirteen patients with a total of 321 nodes with pathological sampling were included. Nodal activity above MBP on PET/CT demonstrated 97.4% sensitivity, 35.8% specificity, 32.8% positive predictive value, and 97.8% negative predictive value. Of the five other PET/CT parameters examined, the two most promising were node SUVmax and node/MBP SUVmax. The node SUVmax cut-off of 3.9 demonstrated 90.9% sensitivity and 61.9% specificity, and the node/MBP SUVmax cut-off of 1.7 demonstrated 90.9% sensitivity and 60.7% specificity. CONCLUSION: Compared to the MBP cut-off, use of a higher node/MBP SUVmax ratio cut-off and use of other PET/CT variables can improve the diagnostic performance of PET/CT for NSCLC nodal staging. In particular, specificity for detecting malignant nodal involvement is improved while maintaining high sensitivity.

[Assessment of ability to drive in patients with MCI and dementia]. / Beurteilung der Fahrtauglichkeit bei Patienten mit MCI und demenziellen Syndromen.

People with mild cognitive impairment and dementia are a frequent and continuously increasing patient group in practically all fields of medicine. The associated challenges involve nearly all areas of life in addition to the direct medical treatment. Assessment of the ability to drive in patients with cognitive deficits is becoming increasingly more important. What are the options available to physicians in order to make a valid assessment? Which legal aspects must be taken into consideration? Which rights and obligations arise from the framework conditions? These questions nowadays give rise to great uncertainty for many medical personnel; however, the increasing importance of these problems necessitates a clear procedure, which allows difficult decisions to be made with utmost sovereignty and legal certainty and to be able to give patients and relatives a plausible explanation. Because age is a substantial risk factor for the development of cognitive disorders, the question of the ability to drive is affected not only by neuropsychiatric diseases, such as mild cognitive disorders or dementia but also the frequently occurring somatic comorbidities. Estimation of the ability to drive is therefore a complex approach, which should be standardized in order to appreciate all relevant aspects. It would be desirable to have a practice-oriented algorithm, the formulation of which is the aim of this article. Additionally, we would like to make a contribution to road safety and make medical personnel fully aware of this topic.

[A new working shift model for anesthesiologists: an analysis 3 years after implementation]. / Neues Dienstzeitenmodell für Ärzte in der Anästhesie : Eine Analyse 3 Jahre nach Implementierung.

OBJECTIVE: The aim of this study was to assess the efficacy, appropriateness and cost-effectiveness of a new working shift model for anesthesiologists complying with the European working time directive (EWTD) at the University Hospital of Tübingen (UKT), Germany 3 years after implementation BACKGROUND: Applying the standards of the EWTD is challenging for university hospitals as doctors must comply with the challenge of combining patient care, research and teaching. So far there have been no data available for German university hospitals on how these requirements can be met. As the department of anesthesiology is also a service-providing department it is essential not to increase staffing costs with a new shift model. METHODS: In 2007 a new working shift model for the department of anesthesiology was designed and introduced in 2008. Shift planning and documentation of working hours were implemented electronically. The calculated number of doctors to run this model was 87.6 full time equivalents (FTE). For 2009 and 2010 the compliance with the EWTD parameters was checked for 1) average weekly working time limit (AWWTL) and 2) compliance to the maximum daily working time limit of 10 h (10 h DWTL). Furthermore, staffing costs for doctors in 2010 were compared to 2007. To check for the time spent in patient care the period of anesthetic attendance (PAA) was chosen, i.e. the total time of patient contact by anesthesiology staff. Data were analyzed descriptively for AWWTL and for 10 h DWTL. FTE, staff costs and PAA were evaluated by one-way ANOVA. RESULTS: The new shift model allowed 84.4 % of all doctors to comply with the individual AWWT limits of 54 h and 48 h in 2009 (81/96) and 76.0 % in 2010 (79/104). In 2009 61.5 % of anesthesiologists voted for opt-out (59/96) and 53.8 % did so in 2010 (56/104). The 10 h DWTL was respected by 84.0 % in 2009 and by 85.9 % in 2010. The mean number of anesthesiologists rose significantly from 78.4 FTE in 2007 to 82.5 FTE in 2009 and 84.6 FTE in 2010 (p < 0.001 for 2010 vs. 2007, p = 0.004 for 2009 vs. 2007 and was not significant for 2010 vs. 2009). Staff costs per FTE increased from 7,524.79 /month to 7,800.66 /month and 7,966.11 /month in 2007, 2009 and 2010, respectively with the differences being non-significant. The PAA increased significantly from a mean of 6,124 h/month in 2007 to 6,581 h/month in 2009 and 6,872 h/month in 2010 (p < 0.001 for 2010 vs. 2007, whereas 2009 vs. 2007 and 2010 vs. 2009 were not significant). Thus, labour costs increased from 96.59 /h PAA in 2007 to 98.53 /h in both 2009 and 2010, the differences being not significant. CONCLUSIONS: The newly designed shift model allowed a fair compliance with the EWTD in respect to AWTL and 10 h DWTL, although the calculated number of doctors to run the shift model could not be met in 2009 and 2010. Violations of the 10 h DWT limits were stable in 2009 and 2010; however the number of doctors exceeding the AWWT limits appeared to increase. The compliance with opt-out decreased from 2009 to 2010 and a high proportion of AWWTL violations resulted from the group of non-opt-out voters. The staff costs per hour PAA after implementation of the new shift model did not differ significantly from the year before although staffing costs increased by 7.2 % between 2007 and 2010. Costs increased by 162,454 /year for all PAA hours in 2010. Further evaluation of staff satisfaction with the new shift models is needed and already under way.

Evaluation of body mass index percentiles for assessment of malnutrition in children with cystic fibrosis.

OBJECTIVE: To compare the performance of recently released body mass index percentiles (BMIp) with standard anthropometric indexes, including height-for-age percentile (HAP), weight-for-age percentile (WAP) and percent ideal body weight (%IBW), as measures for nutritional failure in children with cystic fibrosis (CF). DESIGN: Cross-sectional analysis of growth and lung function data from 4577 children with CF reported to the German CF quality assurance (CFQA) project from 1995 to 2004. RESULTS: Frequency distribution of HAP (mean+/-s.d.: male 30.0+/-27.5; female 31.3+/-27.4) and WAP (male 28.9+/-27.0; female 29.6+/-26.7) were skewed, with significant numbers of patients below the fifth percentiles of a healthy reference population. However, because deficits occurred in both measures simultaneously, mean %IBW (male 97.0+/-12.1; female 98.1+/-12.3) assumed subjects weight close to the nominal weight-for-height at all ages. In contrast, mean BMIp was markedly reduced (male 35.7+/-27.9; female 35.6+/-27.2) and steadily declined with age. Ideal weight-for-age was significantly lower when predicted by %IBW compared with BMIp method, particularly in subjects with shorter-than-average stature. Consequently, less CF children were identified with nutritional failure according to %IBW method (male 20.5%; female 22.7%) compared with BMIp method (male 30.4%; female 28.7%). The clinical relevance of these findings was confirmed by stronger correlation of BMIp with impaired %forced expiratory volume/s, a marker for disease progression in CF. CONCLUSION: BMIp predicts nutritional failure more sensitively and accurately than conventional anthropometric indexes, at least in children with CF. Screening of CF patients by BMIp could provide an early warning sign and allow for timely therapeutic intervention.

[Location of mechanical ventilation in the specialized centre--intensive care unit, respiratory intermediate care unit and the specialized normal ward]. / Ort der maschinellen Beatmung im Beatmungszentrum--Intensivstation, Intermediate care oder spezialisierte Normalstation.

Until recently "mechanical ventilation" meant "intensive care unit (ICU)". Important arguments for more flexibility concerning the locality where patients are mechanically ventilated are the increase in number of patients, costs and reduced resources. The pulmonary centre for mechanical ventilation, where ICU, respiratory intermediate care unit (RICU) and the specialized normal ward are complementary, is an attractive option for the future. The RICU is the key player in this concept, since as a step down unit it represents a cost-effective approach to the care of substantial numbers of selected patients requiring specialized respiratory care, e. g. intensive respiratory monitoring and therapy, particularly those requiring prolonged mechanical ventilation and non-invasive mechanical ventilation. Success of the RICU requires an experienced team, adequate location and high quality of technical equipment, experienced team, adequate location and high quality of technical equipment.

[Pain specialist in the assessment process]. / Der Schmerztherapeut bei der Begutachtung.

Pain specialists are often involved in assessing social medical aspects of chronic pain patients. A standardized examination in the assessment process is not published. Data and statements on the assessment process between 1993 and 1997 were recorded from 15 experts by questionnaire. Statements to 568 reports were made. The majority of performance impairments were caused by back pain (35.9%) and headache (19.3%). All examiners integrated a psychological assessment. Although the assessment processes were very different, all examiners fulfilled the minimal criteria of the presented process for assessment of chronic pain patients. Verifying the symptoms as well as capturing some aspects of aggravation proved to be problematic. The present assessment practice is discussed with regard to the unequal procedure. On basis of the received data and the own experience in examination the process of structured assessment of chronic pain patients is presented under medical and psychological aspects. It contains a recommendation of a standardized process with minimal criteria and an optional supplement of the standardized process with problematical patients (e.g.demonstration, aggravation, simulation). Minimal demands on a qualified assessment of chronic pain patients should contain the study of the history, the German Pain-Questionnaire, the analysis of all the painful complaints with weighting their importance, the examination and the basic registration of sensational, emotional, cognitive, behavioral and social aspects of the chronic pain syndrome. An appended glossary of the most usable psychological tests with comments on their validation criteria aims to provide a more standard multimodal assessment of chronic pain patients complaints and functionability.

Interpreting epidemiological research: blinded comparison of methods used to estimate the prevalence of inherited mutations in BRCA1.

While sequence analysis is considered by many to be the most sensitive method of detecting unknown mutations in large genes such as BRCA1, most published estimates of the prevalence of mutations in this gene have been derived from studies that have used other methods of gene analysis. In order to determine the relative sensitivity of techniques that are widely used in research on BRCA1, a set of blinded samples containing 58 distinct mutations were analysed by four separate laboratories. Each used one of the following methods: single strand conformational polymorphism analysis (SSCP), conformation sensitive gel electrophoresis (CSGE), two dimensional gene scanning (TDGS), and denaturing high performance liquid chromatography (DHPLC). Only the laboratory using DHPLC correctly identified each of the mutations. The laboratory using TDGS correctly identified 91% of the mutations but produced three apparent false positive results. The laboratories using SSCP and CSGE detected abnormal migration for 72% and 76% of the mutations, respectively, but subsequently confirmed and reported only 65% and 60% of mutations, respectively. False negatives therefore resulted not only from failure of the techniques to distinguish wild type from mutant, but also from failure to confirm the mutation by sequence analysis as well as from human errors leading to misreporting of results. These findings characterise sources of error in commonly used methods of mutation detection that should be addressed by laboratories using these methods. Based upon sources of error identified in this comparison, it is likely that mutations in BRCA1 and BRCA2 are more prevalent than some studies have previously reported. The findings of this comparison provide a basis for interpreting studies of mutations in susceptibility genes across many inherited cancer syndromes.

Isotropic beam bouquets for shaped beam linear accelerator radiosurgery.

In stereotactic radiosurgery and radiotherapy treatment planning, the steepest dose gradient is obtained by using beam arrangements with maximal beam separation. We propose a treatment plan optimization method that optimizes beam directions from the starting point of a set of isotropically convergent beams, as suggested by Webb. The optimization process then individually steers each beam to the best position, based on beam's-eye-view (BEV) critical structure overlaps with the target projection and the target's projected cross sectional area at each beam position. This final optimized beam arrangement maintains a large angular separation between adjacent beams while conformally avoiding critical structures. As shown by a radiosurgery plan, this optimization method improves the critical structure sparing properties of an unoptimized isotropic beam bouquet, while maintaining the same degree of dose conformity and dose gradient. This method provides a simple means of designing static beam radiosurgery plans with conformality indices that are within established guidelines for radiosurgery planning, and with dose gradients that approach those achieved in conventional radiosurgery planning.

Does willingness to pay vary by race/ethnicity? An analysis using mammography among low-income women.

As part of a population-based intervention to improve periodic mammogram screening, we examined WTP for mammography in five ethnic groups. Through random digit dialing, we contacted households in low-income census tracts of Alameda County, California (San Francisco Bay area). Women who met the ethnicity, age and cancer-free eligibility criteria were invited to participate. For the baseline assessment, women were surveyed over the phone in their preferred language. Of the 1465 surveyed women, 499 identified themselves as African-American, 199 were Chinese, 167 were Filipino, 300 were Latina, and 300 were non-Hispanic white. Bivariate and multivariate analysis showed that WTP varied significantly by ethnicity (P<0.05). We also found that when Filipino and Chinese women had a female relative with breast cancer, they were willing to pay less money for a mammogram. African-American, Latino, and non-Hispanic white women, however, were willing to pay more money for a mammogram if a female relative had had breast cancer. This ethnic difference, when there is a familial link to breast cancer, needs further study as it has implication for genetic testing. Nevertheless, WTP studies that do not account for ethnic differences may be overstating net benefits to society.

[Costs of type 2 diabetes in Germany. Results of the CODE-2 study]. / Kosten des Typ-2-Diabetes in Deutschland. Ergebnisse der CODE-2-Studie.

BACKGROUND AND OBJECTIVE: Diabetes is an increasing and widespread chronic disease causing considerable costs for the health care system. In the CODE-2 Study (Costs of Diabetes in Europe-Type 2) the total expenses for type 2 diabetics in Germany were evaluated and analyzed for the first time. PATIENTS AND METHODS: The CODE-2-study has been performed in eight European countries. In the German arm of the study, medical, demographic, and economic data of 809 patients were obtained retrospectively for a one year period, using face-to-face interviews with 135 physicians. These results were projected for the overall population of type 2 diabetes patients in Germany. RESULTS: The annual costs caused by type 2 diabetes patients in Germany in 1998 amount to 31.4 billion DM. The majority of these costs (61%) were covered by statuatory and private health insurance. The annual expenses of the statuatory Health Insurance (SHI) for these patients amounted to 18.5 billion DM. These costs divided in 50% spent for inpatient treatment, 13% for ambulatory care, and 27% for medication. Diabetes medication (insulin, oral antidiabetic drugs) accounted for only 7% of total SHI costs. Only 26% of all diabetic patients were adjusted to HbA1c values < 6.5% according to the therapeutic targets of the European Diabetes policy group. 50% of the type 2 diabetic patients exhibited severe macro- and/or microvascular complications. The costs per patient--compared to the average expenses for SHI insured patients--increased with complication state from the 1.3-fold (no complications) up to the 4.1-fold (macro- and microvascular complications). CONCLUSIONS: The overall costs for patients with type 2 diabetes are higher than expected from previous estimates. Diabetes related complications and concomitant diseases are the predominant reasons for these high costs. Control of blood glucose is inadequate for the majority of diabetic patients. To prevent long-term complications, an optimized treatment of type 2 diabetes is imperative not only from a medical but also from a health economics point of view.

The demand for consumer health information.

Using data from an evaluation of a community-wide informational intervention, we modeled the demand for medical reference books, telephone advice nurses, and computers for health information. Data were gathered from random household surveys in Boise, ID (experimental site), Billings, MT, and Eugene, OR (control sites). Conditional difference-in-differences show that the intervention increased the use of medical reference books, advice nurses, and computers for health information by approximately 15, 6, and 4%. respectively. The results also suggest that the intervention was associated with a decreased reliance on health professionals for information.

Willingness to pay for mammography: item development and testing among five ethnic groups.

The goal of this study was to develop a willingness to pay (WTP) question for mammography that is appropriate for low income, ethnically-diverse women. Through qualitative research with 50 low income women of five ethnic groups we developed both a WTP question and a willingness to travel question (WTT). After being refined through interviews with 41 women, these questions were pilot tested on a random sample of 52 low income, ethnically-diverse women in the San Francisco area. Results show that the concepts underlying WTP and WTT were culturally appropriate to the five ethnicities in this study. Analyses generally confirm the validity of the WTP and WTT questions. As expected, WTP was associated with household income, perceived risk of cancer, and knowledge that one needs a mammogram even after a clinical breast examination. Despite the small samples, WTP varied among the ethnic groups. Additionally, WTT was moderately correlated with the natural log of WTP (r = 0.58, P < 0.001). These questions are now in use in a larger clinical trial and future analyses will explore willingness to pay and willingness to travel within and across the ethnic groups.

Healthcare utilization among Hispanics: findings from the 1994 Minority Health Survey.

OBJECTIVE: To assess the effects of health need, enabling factors, and predisposing factors on entry into any type of care, volume of care, use of emergency services, hospitalization, and receipt of preventive services. STUDY DESIGN: Multiple regression analysis with cross-sectional data. PATIENTS AND METHODS: Participants were the 1001 adults who identified themselves as Hispanic in the Commonwealth Fund Minority Health Survey; a telephone survey of noninstitutionalized persons designed to oversample minorities was conducted. RESULTS: The 3 Hispanic subpopulations had similar sociodemographic profiles and similar patterns of healthcare utilization, except that Hispanics of other national origins were more likely to use preventive care compared with Mexican Americans and Puerto Ricans. Overall, 78% of the Hispanics surveyed entered the healthcare system in the past year, making an average of 5.25 visits. After controlling for other factors, immigrants had fewer visits and were less likely to have received preventive care. A regular source of care and insurance coverage influenced entry and volume of care, but was not associated with emergency services or hospitalizations. CONCLUSIONS: Access to care for Hispanics remains a major problem, significantly affected by structural and financial factors, personal experiences with the healthcare system, and predisposing factors. Policy solutions that address the health service needs of the uninsured will largely benefit Hispanics. In addition, as managed care plans compete for contracts and become more multicultural, access to care for Hispanics, including the uninsured, may improve through market forces.

Health services utilization among Latinos and white non-Latinos: results from a national survey.

Utilization patterns may be changing as managed care organizations actively market services to Latinos. This study compares use of any care, emergency services, inpatient hospitalization, nonemergency outpatient care only, and preventive care among 1,001 self-identified Latino and 1,107 white non-Latino adults. Data were from the 1994 Commonwealth Fund Survey of Minority Health. Latinos were less likely than white non-Latinos to have entered the health system for any type of care, to have been admitted to a hospital, or to have used preventive care. Access to a regular source of care along with financial factors reduced the ethnic/racial gap in the use of any care and preventive care, yet cultural and behavioral factors contributed little. Latinos in managed care plans, compared with fee-for-service systems, were twice as likely to receive preventive care. This suggests that managed care has the potential to reduce inequities in preventive care utilization.

Economic considerations in overactive bladder.

Many costs are associated with overactive bladder (OAB). They include direct costs, such as those associated with treatment, diagnosis, routine care, and the consequences of the disease; indirect costs of lost wages and productivity; and intangible costs associated with pain, suffering, and decreased quality of life. Quantification of all these costs is essential for establishing the total economic burden of a disease on society. Currently, the total economic burden of OAB is unknown. However, various studies have determined that the economic burden of urinary incontinence, one of the symptoms of OAB, is substantial. It is also important to establish the economic impact of various interventions for OAB. Cost-minimization, cost-outcome, cost-utility, and cost-benefit models can be used for these analyses. The most difficult aspect of evaluating the economic impact of a treatment is estimating the intangible costs.

[Cost comparison of hospital and ambulatory i.v. therapy in adult cystic fibrosis patients. Results of a controlled prospective study]. / Kostenvergleichsanalyse der stationären und ambulanten Intervalltherapie bei erwachsenen Mukoviszidosepatienten. Ergebnisse einer prospektiven kontrollierten Studie.

BACKGROUND: The regular i.v.-therapy of adults with cystic fibrosis (CF) on an in-patient basis is regarded as expensive. Home treatment is supposed to be cheaper. During a prospective controlled study to compare in-patient treatment (SIT) with home i.v.-treatment (HIT) in regard to clinical, psychosocial and economic parameters, delivered health services and costs in the German setting were evaluated in a comparable manner. PATIENTS AND METHODS: During the study period 4/95 to 9/96 45 patients with altogether 56 hospital and 40 home i.v.-courses of approximately 14 days were included in the study. Principal instruments to record the resource consumption were documentation sheets kept by the medical staff and the patients. In addition, pharmacy accounts in HIT and patient records and hospital controlling data in SIT were used. RESULTS: The average costs of a course were 14,038 DM for HIT and 18,702 DM for SIT. Striking are the large differences in medication costs. Two main reasons could be identified for the cost difference: 1, the use of a mobile infusion system in HIT and 2, the much higher prices of pharmaceuticals in the ambulatory care sector compared to the hospital sector, where extremely high profits of the home care service firms or the pharmacy can be supposed. The social costs of HIT (when antibiotics are valued to opportunity costs) are estimated at less than 10,500 DM. From a societal perspective HIT is preferable, from the perspective of the statutory health insurance funds hospital therapy is preferable. CONCLUSIONS: 1. The widely accepted hypothesis that ambulatory care is cheaper than hospital care is--at least in the German setting--not a-priori true. 2. In the treatment of CF patients incentive failures exist which induce unnecessary and avoidable hospital stays if the perspective of the statutory sickness funds is dominant. 3. Changes in system conditions as e.g. the permission of mail-order pharmacies might help to implement a more rational allocation of resources.

Who gets second opinions?

Six states require health plans to provide or authorize second medical opinions (SMOs). The intent of such legislation is to preserve consumer choice, to improve the flow of information, and to improve health outcomes in this era of managed care. However, it is unclear who benefits from these laws. This paper reviews the changing role of second opinions and, using a nationally representative data set from the Commonwealth Fund, examines who gets them. Of persons who had visited a doctor in the previous year, 19 percent received a second opinion, for an estimated cost of $3.2 billion in 1994. Findings suggest that cultural norms and sociocultural factors may partially determine who may benefit from SMO legislation.

High-precision assessment of interface lattice offset by quantitative HRTEM.

We introduce a new method to determine the 'lattice offset' or 'rigid-body shift' between two crystals forming an interface. Our method relies on quantitative evaluation of high-resolution transmission electron microscopy images. Employing the (001)-orientated interface between Al and MgAl2O4 in parallel orientation as a model system we demonstrate that we can assess the interface lattice offset with a precision in the picometre range.