Ralph Crott

Role of PET in the Initial Staging of Cutaneous Malignant Melanoma: Systematic Review

PURPOSE To calculate summary estimates of the diagnostic performance of fluorine 18 fluorodeoxyglucose (FDG) positron emission tomographic (PET) imaging in the initial staging of cutaneous malignant melanoma (CMM), following the new American Joint Committee on Cancer (AJCC) staging classification on per-patient and per-lesion bases. MATERIALS AND METHODS MEDLINE, EMBASE, Web of Science, and Cochrane Database of Systematic Reviews databases, and reference lists of reviews and included papers were searched, without any language restrictions, for relevant articles published before March 2007. Two reviewers independently assessed study eligibility and methodologic quality by using the quality assessment of diagnostic accuracy studies checklist. A pooled random effect was estimated and a fixed coefficient regression model was used to explore the existing heterogeneity. RESULTS Twenty-eight studies involving 2905 patients met the inclusion criteria. The pooled estimates of FDG PET for the detection of metastasis in the initial staging of CMM were sensitivity, 83% (95% confidence interval [CI]: 81%, 84%); specificity, 85% (95% CI: 83%, 87%); positive likelihood ratio (LR), 4.56 (95% CI: 3.12, 6.64); negative LR, 0.27 (95% CI: 0.18, 0.40); and diagnostic odds ratio, 19.8 (95% CI: 10.8, 36.4). Results from eight studies suggested that FDG PET was associated with 33% disease management changes (range, 15%-64%). CONCLUSION There is good preliminary evidence that FDG PET is useful for the initial staging of patients with CMM, especially as adjunctive role in AJCC stages III and IV, to help detect deep soft-tissue, lymph node, and visceral metastases. FDG PET-computed tomographic imaging seemed to be more precise than PET alone, as suggested by four eligible studies. Further evaluation by using a well-designed prospective study, with clinical outcome-focused measures and cost effectiveness analysis, is needed to clarify the appropriate role of FDG PET in CMM staging. SUPPLEMENTAL MATERIAL http://radiology.rsnajnls.org/cgi/content/full/249/3/836/DC1.

Infectious complications following conversion to buttonhole cannulation of native arteriovenous fistulas: a quality improvement report.

BACKGROUND Constant-site or buttonhole cannulation of native arteriovenous fistulas (AVFs) has gained in popularity compared with rope-ladder cannulation. However, cannulating nonhealed skin might increase the risk of (AVF-related) infectious events, as suggested by small reports. STUDY DESIGN Quality improvement report. SETTING & PARTICIPANTS All patients on in-center hemodialysis therapy using a native AVF from January 1, 2001, to June 30, 2010. QUALITY IMPROVEMENT PLAN Shift to buttonhole cannulation between August 2004 and January 2005. Because the infectious event rate increased after the shift, educational workshops were held in May 2008 for all nurses, with review of every step of buttonhole protocol. OUTCOMES Infectious events (unexplained bacteremia caused by skin bacteria and/or local AVF infection) and complicated infectious events (resulting in metastatic infection, death, or AVF surgery) were ascertained during 4 periods: (1) rope-ladder technique in all, (2) switch to buttonhole, (3) buttonhole in all before workshops, and (4) buttonhole in all after workshops. RESULTS 177 patients (aged 70.4 ± 11.5 years) with 193 AVFs were analyzed, including 186,481 AVF-days. 57 infectious events occurred (0.31 events/1,000 AVF-days). The incidence of infectious events increased after the switch to the buttonhole method (0.17 [95% CI, 0.086-0.31], 0.11 [95% CI, 0.0014-0.63], and 0.43 [95% CI, 0.29-0.61] events/1,000 AVF-days in periods 1, 2, and 3, respectively; P = 0.003). This reached significance during only the second full year of buttonhole cannulation. During period 4, the incidence tended to decrease (0.34 events/1,000 AVF-days). Complicated infectious events (n = 12) were virtually restricted to period 3 (n = 11; 0.153 [95% CI, 0.076-0.273] events/1,000 AVF-days), with a significant decrease in period 4 (n = 1; 0.024 [95% CI, 0.001-0.118] events/1,000 AVF-days; RR for period 3 vs period 4, 6.37 [95% CI, 1.09-138.4]; P = 0.04). LIMITATIONS Observational partly retrospective design. CONCLUSION Intensive staff education regarding strict protocol for the buttonhole procedure was associated with a decrease in infectious events.

Comparison of three instruments assessing the quality of economic evaluations: A practical exercise on economic evaluations of the surgical treatment of obesity.

OBJECTIVES The increasing use of full economic evaluations has led to the development of various instruments to assess their quality. The purpose of this study was to compare the frequently used British Medical Journal (BMJ) check-list and two new instruments: the Consensus Health Economic Criteria (CHEC) list and the Quality of Health Economic Studies (QHES) instrument. The analysis was based on a practical exercise on economic evaluations of the surgical treatment of obesity. METHODS The quality of nine selected studies was assessed independently by two health economists. To compare instruments, the Spearman rank correlation coefficient was calculated for each assessor. Moreover, the test-retest reliability for each instrument was assessed with the intraclass correlation coefficient (ICC) (3,1). Finally, the inter-rater agreement for each instrument was estimated at two levels: comparison of the total score of each article by the ICC(2,1) and comparison of results per item by kappa values. RESULTS The Spearmans rank correlation coefficient between instruments was usually high (rho > 0.70). Furthermore, test-retest reliability was good for every instruments, that is, 0.98 (95 percent CI, 0.86-0.99) for the BMJ check-list, 0.97 (95 percent CI, 0.73-0.98) for the CHEC list, and 0.95 (95 percent CI, 0.75-0.99) for the QHES instrument. However, inter-rater agreement was poor (kappa < 0.40 for most items and ICC(2,1) < or = 0.5). CONCLUSIONS The study shows that the results of the quality assessment of economic evaluations are not so much influenced by the instrument used but more by the assessor. Therefore, quality assessments should be performed by at least two independent experts and final scoring based on consensus.

Interstitial Fibrosis Restricts Osmotic Water Transport in Encapsulating Peritoneal Sclerosis

Encapsulating peritoneal sclerosis (EPS) is a rare but severe complication of peritoneal dialysis (PD) characterized by extensive fibrosis of the peritoneum. Changes in peritoneal water transport may precede EPS, but the mechanisms and potential predictive value of that transport defect are unknown. Among 234 patients with ESRD who initiated PD at our institution over a 20-year period, 7 subsequently developed EPS. We evaluated changes in peritoneal transport over time on PD in these 7 patients and in 28 matched controls using 3.86% glucose peritoneal equilibration tests. Compared with long-term PD controls, patients with EPS showed early loss of ultrafiltration capacity and sodium sieving before the onset of overt EPS. Multivariate analysis revealed that loss of sodium sieving was the most powerful predictor of EPS. Compared with long-term PD control and uremic peritoneum, EPS peritoneum showed thicker submesothelial fibrosis, with increased collagen density and a greater amount of thick collagen fibers. Reduced osmotic conductance strongly correlated with the degree of peritoneal fibrosis, but not with vasculopathy. Peritoneal fibrosis was paralleled by an excessive upregulation of vascular endothelial growth factor and endothelial nitric oxide synthase, but the expression of endothelial aquaporin-1 water channels was unaltered. Our findings suggest that an early and disproportionate reduction in osmotic conductance during the course of PD is an independent predictor of EPS. This functional change is linked to specific alterations of the collagen matrix in the peritoneal membrane of patients with EPS, thereby validating the serial three-pore membrane/fiber matrix and distributed models of peritoneal transport.

Activity-based costing evaluation of a [18F]-fludeoxyglucose positron emission tomography study

OBJECTIVE The aim of the study is to use the activity-based costing approach to give a better insight in the actual cost structure of a positron emission tomography procedure (FDG-PET) by defining the constituting components and by simulating the impact of possible resource or practice changes. METHODS The cost data were obtained from the hospital administration, personnel and vendor interviews as well as from structured questionnaires. A process map separates the process in 16 patient- and non-patient-related activities, to which the detailed cost data are related. One-way sensitivity analyses shows to which degree of uncertainty the different parameters affect the individual cost and evaluate the impact of possible resource or practice changes like the acquisition of a hybrid PET/CT device, the patient throughput or the sales price of a 370MBq (18)F-FDG patient dose. RESULTS The PET centre spends 73% of time in clinical activities and the resting time after injection of the tracer (42%) is the single largest departmental cost element. The tracer cost and the operational time have the most influence on cost per procedure. The analysis shows a total cost per FDG-PET ranging from 859 Euro for a BGO PET camera to 1142 Euro for a 16 slices PET-CT system, with a distribution of the resource costs in decreasing order: materials (44%), equipment (24%), wage (16%), space (6%) and hospital overhead (10%). CONCLUSIONS The cost of FDG-PET is mainly influenced by the cost of the radiopharmaceutical. Therefore, the latter rather than the operational time should be reduced in order to improve its cost-effectiveness.

Pricing and reimbursement of pharmaceuticals in Belgium.

SummaryThe Belgian healthcare system has a tradition of access and equity at affordable prices. As in other countries, the system becomes pressured by increasing healthcare costs. This paper describes the actual situation in Belgium with special focus on pharmaceutical products and the potential role of pharmacoeconomics in decision making on price and reimbursement.Nearly all people in Belgium are covered by compulsory health insurance. The system is paid for by social security. the patients and the federal and regional authorities. The part of the consumption of pharmaceuticals that is charged to insurance was about 62.1 billion Belgian francs (BeF), i.e. about 50% of the pharmaceutical market in 1994.Price setting in Belgium has been rather low due to the positive reimbursement list. where the price of a new drug is compared to existing drugs in a comparable therapeutic class (so-called reimbursement criteria).The expenditure on pharmaceuticals is increasing faster than global funding for public health. In order to control drug budgets. different cost-containment measures have been or are being taken. i.e. a mix of price, reimbursement and volume controls. These cost-containment measures are not necessarily in accordance with a health economic approach.This paper suggests the scope for better implementation of pharmacoeconomic Evaluation, which can lead to more flexible reimbursement systems in specific indications. Therefore. a formal recognition of the role of objective economic evaluations is needed for both hospital and ambulatory care. This process should be proceeded by improving the understanding and robustness of pharmacoeconomic evaluations.

Mapping algorithms from QLQ-C30 to EQ-5D utilities: no firm ground to stand on yet

Aim: Over the last years several mapping or cross-walking algorithms for deriving utilities from QLQ-C30 scores have been published. However their external predictive accuracy has not yet been systematically compared. Methods: We tested the external validity of previously published mapping algorithms to transform the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire responses to EQ-5D derived Utilities. Results: When applied to different data sets, the currently published mapping showed a large variation between algorithms of the values of the mapped utilities, a low accuracy of the mapping compared to the observed EQ-5D utilities and no consistent performance between competing algorithms. Discussion: Therefore direct mapping from QLQ-C30 profiles to EQ-5D utilities using published algorithms should be viewed cautiously.

Recommended structure for reporting economic evaluation on pharmaceuticals in Belgium

Pharmaco‐economic evaluations become more important for the reimbursement of pharmaceuticals, and will be obligatory for new pharmaceutical drugs for which an added therapeutic value is claimed and a price premium is proposed by the manufacturer. Therefore, it is important to guide purchasers and providers of pharmaceutical care in their efforts related to the evaluation process. Standard Report Format can support the quality, transparency and exhaustiveness of the data submitted. A multidisciplinary task force developed a Standard Report Format for pharmaco‐economic evaluations in Belgium.

A one-year economic evaluation of six alternative strategies for the management of uninvestigated upper gastrointestinal symptoms in Canadian primary care

BACKGROUND The cost-effectiveness of initial strategies in managing Canadian patients with uninvestigated upper gastrointestinalsymptoms remains controversial. OBJECTIVE To assess the cost-effectiveness of six management approaches to uninvestigated upper gastrointestinal symptoms in the Canadian setting. METHODS The present study analyzed data from four randomized trials assessing homogeneous and complementary populations of Canadian patients with uninvestigated upper gastrointestinal symptoms with comparable outcomes. Symptom-free months, qualityadjusted life-years (QALYs) and direct costs in Canadian dollars of two management approaches based on the Canadian Dyspepsia Working Group (CanDys) Clinical Management Tool, and four additional strategies (two empirical antisecretory agents, and two prompt endoscopy) were examined and compared. Prevalence data, probabilities, utilities and costs were included in a Markov model, while sensitivity analysis used Monte Carlo simulations. Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves were determined. RESULTS Empirical omeprazole cost

Is a methodology available that accurately measures the cost of an FDG-PET study?

226 per QALY (