Infectious Complications Associated to Buttonhole Cannulation of Native Arteriovenous Fistulas: A 22-year follow-up.

BACKGROUND AND HYPOTHESIS: Buttonhole cannulation of native arteriovenous fistulas (AVFs) appears associated with an increased infectious risk. We previously reported a dramatic increase in the incidence of infectious events after shift to buttonhole in an in-center hemodialysis unit, largely reduced after staff (re)education regarding strict respect of the procedure. We assessed the evolution over the following 12-years period in our center. METHODS: In this prospective follow-up of a previous, pre (rope-ladder)-post (buttonhole) comparison (2001-2010), all in-center hemodialysis patients with a native AVF were included from July 1st, 2010 to December 31st, 2022. Primary and secondary outcomes were infectious events (unexplained bacteraemia due to skin bacteria and/or local AVF infection) and complicated infectious events (metastatic infection, AVF surgery, death). Overall, the impact of several quality improvement strategies was tested according to the events rate over 6 periods: 1: Rope-ladder in all; 2: switch to buttonhole; 3: buttonhole in all, before workshops; 4: buttonhole in all, after workshops; 5: buttonhole withdrawal in problematic AVFs; 6: additional procedural changes. RESULTS: This extended observation period allowed adding 195,180 AVF-days to our previous report. Overall, 381,661 AVF-days (366 AVFs, 345 patients) were analysed. After an increase of the infectious events rate in 2012, the shift to rope-ladder in problematic AVFs during Period 5 did not have a significant impact. The incidence of infectious events decrease significantly during Period 6 compared to Periods 3, 4 and 5 [IRR 0.24 (95%CI 0.09-0.52) p=0.0001, IRR 0.22 (95%CI 0.09-0.47) p<0.0001, and IRR 0.29 (95%CI 0.11-0.66) p=0.001, respectively] and became eventually for the first time comparable to Period 1 [IRR 0.59 (95%CI 0.21-1.62) p=0.27]. CONCLUSION: The constant observance of reinforced hygiene protocols by trained staff and central coordination succeeded in significantly mitigating the infectious risk associated with buttonhole.

Podocyte Antigen Staining to Identify Distinct Phenotypes and Outcomes in Membranous Nephropathy: A Retrospective Multicenter Cohort Study.

RATIONALE & OBJECTIVE: Membranous nephropathy (MN) is characterized by the deposition of immune complexes along glomerular basement membranes. M-Type phospholipase A2 receptor (PLA2R), thrombospondin type 1 domain-containing 7A (THSD7A), exostosin 1 and 2 (EXT1/2), and neural epidermal growth factor-like 1 protein (NELL-1) have been identified as established or potential podocyte antigens in MN. We investigated the association of podocyte antigen staining with MN clinical phenotype and outcomes. STUDY DESIGN: Multicenter retrospective cohort study. SETTING & PARTICIPANTS: 177 consecutive patients with MN unrelated to lupus erythematosus, identified after screening of 3,875 native kidney biopsies performed in the Belgian UCLouvain Kidney Disease Network from 2000 through 2018. PREDICTOR: Positive immunostaining for podocyte antigens on archived kidney biopsy samples. OUTCOMES: Association with different phenotypes (baseline characteristics of patients and pathologic findings on kidney biopsy), time to cancer and to kidney failure. ANALYTICAL APPROACH: Kaplan-Meier estimates and Cox regression analyses to assess time to cancer and kidney failure. RESULTS: 177 patients were followed up for a median of 4.0 (IQR, 1.3-8.0) years. Diagnosis of PLA2R-positive (PLA2R+), THSD7A+, and double-negative (PLA2R-/THSD7A-) MN was made in 117 (66.1%), 6 (3.4%), and 54 (30.5%) patients, respectively. Progression to kidney failure was similar in all groups. Although the number of patients with THSD7A+MN was small, they showed a higher incidence (50%) and increased risk for developing cancer during follow-up (adjusted HR, 5.0 [95% CI, 1.4-17.9]; P=0.01). 8% and 5% of patients with double-negative MN stained positively for EXT1/2 and NELL-1, respectively. Most patients with EXT1/2+MN were women, had features of systemic autoimmunity, and showed glomerular C1q deposits. LIMITATIONS: Retrospective design; small number of patients in the THSD7A group; lack of evaluation of immunoglobulin G subclasses deposition. CONCLUSIONS: Our real-world data describe the relative prevalence of subgroups of MN and support the hypothesis that a novel classification of MN based on podocyte antigen staining may be clinically relevant.

Direct Mapping of the QLQ-C30 to EQ-5D Preferences: A Comparison of Regression Methods.

BACKGROUND: Several mapping or cross-walking algorithms for deriving utilities from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ-C30) scores have been published in recent years. However, the large majority used ordinary least squares (OLS) regression, which proved to be not very accurate because of the specifics of the quality-of-life measures. OBJECTIVE: Our objective was to compare regression methods that have been used to map EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) utility values from the general EORTC QLQ-C30 using OLS as a benchmark while fixing the number of explanatory variables and to explore an alternative three-part model. METHODS: We conducted a regression analysis of predicted EQ-5D-3L utilities generated using data from an observational study in ambulatory patients with non-small-cell lung cancer in a Toronto hospital. Six alternative regression methods were compared with a simple OLS regression as benchmark. The six alternative regression models were Tobit, censored least absolute deviation, normal mixture, beta, zero-one inflated beta and a mix of piecewise OLS and logistic regression. RESULTS: The best predictive fit was obtained by a mix of OLS regression(s) for utilities lower than 1 with a cut-off point of 0.50 and a separate binary logistic regression for utilities equal to one. Zero-one inflated beta regression was also promising. However, OLS regression proved to be the most accurate for the mean. The prediction of utilities equal to one was poor in all regression approaches. CONCLUSIONS: Three-part regression methods that separately target low, medium and high (<0.50, 0.51-0.99 or 1) utilities seem to have better prediction power than OLS with EQ-5D-3L data, although OLS also seems quite robust. Exploration of three-part approaches compared with single (OLS) regression should be further tested in other similar datasets or using individual pooled data from various clinical or observational studies. The use of alternative goodness-of-fit measures for mapping studies and their influence on the choice of the best performing methods should also be investigated.

Comprehensive cost analysis of sentinel node biopsy in solid head and neck tumors using a time-driven activity-based costing approach.

Head and neck cancer (HNC) is predominantly a locoregional disease. Sentinel lymph node (SLN) biopsy offers a minimally invasive means of accurately staging the neck. Value in healthcare is determined by both outcomes and the costs associated with achieving them. Time-driven activity-based costing (TDABC) may offer more precise estimates of the true cost. Process maps were developed for nuclear medicine, operating room and pathology care phases. TDABC estimates the costs by combining information about the process with the unit cost of each resource used. Resource utilization is based on observation of care and staff interviews. Unit costs are calculated as a capacity cost rate, measured as a Euros/min (2014), for each resource consumed. Multiplying together the unit costs and resource quantities and summing across all resources used will produce the average cost for each phase of care. Three time equations with six different scenarios were modeled based on the type of camera, the number of SLN and the type of staining used. Total times for different SLN scenarios vary between 284 and 307 min, respectively, with a total cost between 2794 and 3541€. The unit costs vary between 788€/h for the intraoperative evaluation with a gamma-probe and 889€/h for a preoperative imaging with a SPECT/CT. The unit costs for the lymphadenectomy and the pathological examination are, respectively, 560 and 713€/h. A 10 % increase of time per individual activity generates only 1 % change in the total cost. TDABC evaluates the cost of SLN in HNC. The total costs across all phases which varied between 2761 and 3744€ per standard case.

Simulation and comparison of progression-free survival among patients with non-squamous non-small-cell lung cancer receiving sequential therapy.

OBJECTIVES: In recent years, the treatment landscape in advanced non-squamous non-small-cell lung cancer (nsNSCLC) has changed. New therapies (e.g., bevacizumab indicated in first line) have become available and other therapies (e.g., pemetrexed in first line and second line) moved into earlier lines in the treatment paradigm. While there has been an expansion of the available treatment options, it is still a key research question which therapy sequence results in the best survival outcomes for patients with nsNSCLC. METHODS: A therapy-sequencing disease model that approximates treatment outcomes in up to five lines of treatment was developed for patients with nsNSCLC. The primary source of data for progression-free survival (PFS) and time to death was published pivotal trial data. All patients were treatment-naïve and in the PFS state, received first-line treatment with either bevacizumab-based therapy or doublet chemotherapy (including the option of pemetrexed + cisplatin). Patients would then progress to a subsequent line of therapy, remain in PFS or die. In case of progression, it was assumed that each survivor would receive a subsequent line of therapy, based on EMA licensed therapies. Weibull distribution curves were fitted to the data. RESULTS: All bevacizumab-based first-line therapy sequences analyzed achieved total PFS of around 15 months. Bevacizumab + carboplatin + paclitaxel (first line) → pemetrexed (second line) → erlotinib (third line) → docetaxel (fourth line) resulted in total mean PFS time of 15.7 months, for instance. Sequences with pemetrexed in combination with cisplatin in first line achieved total PFS times between 12.6 and 12.8 months with a slightly higher total PFS time achieved when assuming pemetrexed continuation therapy in maintenance after pemetrexed + cisplatin in first-line induction. Overall survival results followed the same trend as PFS. CONCLUSION: The model suggests that treatment-sequencing strategies starting with a bevacizumab-based combination in first line yield better survival outcomes than those starting with pemetrexed-based combinations, a result that is attributable to the possibility of one further line of treatment with first-line bevacizumab-based treatment sequences.

Cost comparison of open approach, transoral laser microsurgery and transoral robotic surgery for partial and total laryngectomies.

Activity-based costing is used to give a better insight into the actual cost structure of open, transoral laser microsurgery (TLM) and transoral robotic surgery (TORS) supraglottic and total laryngectomies. Cost data were obtained from hospital administration, personnel and vendor structured interviews. A process map identified 17 activities, to which the detailed cost data are related. One-way sensitivity analyses on the patient throughput, the cost of the equipment or operative times were performed. The total cost for supraglottic open (135-203 min), TLM (110-210 min) and TORS (35-130 min) approaches were 3,349 euro (3,193-3,499 euro), 3,461 euro (3,207-3,664 euro) and 5,650 euro (4,297-5,974 euro), respectively. For total laryngectomy, the overall cost were 3,581 euro (3,215-3,846 euro) for open and 6,767 euro (6,418-7,389 euro) for TORS. TORS cost is mostly influenced by equipment (54%) where the other procedures are predominantly determined by personnel cost (about 45%). Even when we doubled the yearly case-load, used the shortest operative times or a calculation without robot equipment costs we did not reach cost equivalence. TORS is more expensive than standard approaches and mainly influenced by purchase and maintenance costs and the use of proprietary instruments. Further trials on long-term outcomes and costs following TORS are needed to evaluate its cost-effectiveness.

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.

A systematic review of the predictive value of (18)FDG-PET in esophageal and esophagogastric junction cancer after neoadjuvant chemoradiation on the survival outcome stratification.

PURPOSE: We studied the predictive value of [(18) F]fluorodeoxyglucose-positron emission tomography ((18)FDG-PET) for assessing disease-free (DFS) and overall survival (OS) in esophageal and esophagogastric junction cancer. MATERIALS AND METHODS: A literature search (PUBMED/MEDLINE, EMBASE, Cochrane) was performed to identify full papers with (18)FDG-PET and survival data, using indexing terms and free text words. Studies with >10 patients with locally advanced esophageal cancer, presenting sequential or at least one post-adjuvant treatment (18)FDG-PET data and Kaplan-Meier survival curves with >6 months median follow-up period were included. We performed a meta-analysis for DFS and OS using the hazard ratio (HRs) as outcome measure. Sources of heterogeneity study were also explored. RESULTS: We identified 26 eligible studies including a total of 1,544 patients (average age 62 years, 82% males). The TNM distribution was as follows: stage I 7%, II 24%, III 53% and IV 15%. The pooled HRs for complete metabolic response versus no response were 0.51 for OS (95% CI, 0.4-0.64; P < 0.00001) and 0.47 for DFS (95% CI, 0.38-0.57; P < 0.00001), respectively. No statistical heterogeneity was present. To explore sources of clinical heterogeneity, we also realised subgroup and regression analyses. Taken into account the moderate correlation between OS and DFS (ρ = 0.54), we used joint bivariate random regression model. These analyses did not show a statistically significant impact of study characteristics and PET modalities on the pooled outcome estimates. CONCLUSION: Despite methodological and clinical heterogeneity, metabolic response on (18)FDG-PET is a significant predictor of long-term survival data.

An assessment of the external validity of mapping QLQ-C30 to EQ-5D preferences.

BACKGROUND: Although cancer-specific Health-related Quality-of-Life measures are commonly included in randomized clinical trials or other prospective non-randomized clinical studies, it is rare that preference-based instruments are used, which allow the calculation of a Utility weight suitable for estimating Quality-adjusted Life-Years gained. OBJECTIVE: To test the external validity of a previously published mapping algorithm to transform the EORTC QLQ-C30 questionnaire responses into EQ-5D-derived utilities by predicting EQ-5D utilities from QLQ-C30 scores. STUDY DESIGN AND METHODS: Comparative retrospective data analysis of four multicentre, prospective clinical trials in Breast, Multiple Myeloma, Non-Hodgkin Lymphoma and Non-Small-Cell Lung cancer patients with, respectively, 219, 172, 132 and 172 patients. Regression analysis of individual pairs of EQ-5D and QLQ-C30 scores. RESULTS: Although the internal predictive power of a previously published mapping equation was high, its external validity when tested on a set of unrelated external data sets in other cancers proved to underestimate both the mean and variance of the mapped EQ-5D utilities. Furthermore, it appears that the relationship between QLQ-C30 scores and EQ-5D values is not stable across the different data sets. CONCLUSIONS: Validation of the proposed algorithm in other external clinical data sets should be encouraged as well as the application of other more complex mapping methods to enhance accuracy of mapping. In the meanwhile, direct mapping from QLQ-C30 profiles to EQ-5D utilities using published algorithms should be performed with reservations.

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.

A one-year economic evaluation of six alternative strategies in 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 $226 per QALY ($49 per symptom-free month) per patient. CanDys omeprazole and endoscopy approaches were more effective than empirical omeprazole, but more costly. Alternatives using H2-receptor antagonists were less effective than those using a proton pump inhibitor. No significant differences were found for most incremental cost-effectiveness ratios. As willingness to pay (WTP) thresholds rose from $226 to $24,000 per QALY, empirical antisecretory approaches were less likely to be the most costeffective choice, with CanDys omeprazole progressively becoming a more likely option. For WTP values ranging from $24,000 to $70,000 per QALY, the most clinically relevant range, CanDys omeprazole was the most cost-effective strategy (32% to 46% of the time), with prompt endoscopy-proton pump inhibitor favoured at higher WTP values. CONCLUSIONS: Although no strategy was the indisputable cost effective option, CanDys omeprazole may be the strategy of choiceover a clinically relevant range of WTP assumptions in the initial management of Canadian patients with uninvestigated dyspepsia.

Comparing the quality of care across Belgian hospitals from medical basic datasets: the case of thromboembolism prophylaxis after major orthopaedic surgery.

RATIONALE, AIMS AND OBJECTIVES: In the current context, the assessment of the quality of care in daily clinical practice becomes essential. The aim of this study was to use medical basic datasets associated with information on pharmacological treatments to assess the quality of care of a prophylaxis treatment after major orthopaedic surgery and to compare hospitals' clinical practices. METHODS: The study was performed in 20 Belgian hospitals. Patients who underwent total hip replacement (THR), total knee replacement (TKR), or hip fracture surgery (HFS) were selected retrospectively from the hospitals' 2002 and 2003 administrative databases (n = 14,991). Quality indicators assessed were incidence of venous thromboembolism, major bleeding and death. Prophylaxis analysed were enoxaparin, nadroparin and fondaparinux. RESULTS: Venous thromboembolism and major bleeding events were rare (1.9% and 1.1% respectively). Patients who underwent HFS were at greater risk of having pulmonary embolism [OR = 2.01; confidence interval (CI) = 1.38-2.92; P = 0.0002], major bleeding (OR = 4.00; CI = 2.93-5.46; P < 0.0001) or death from any cause (OR = 8.86; CI = 6.85-11.45; P < 0.0001) than patients who underwent THR or TKR. Multivariate analyses showed that the hospital variable had a significant impact on the probability to have adverse events and that patients who received enoxaparin were at greater risk of death than patients who received nadroparin (OR(enoxaparin vs fraxiparin) = 1.59; 95% CI = 1.04-2.44; P = 0.033). CONCLUSION: Results indicate that differences in thromboembolism prophylaxis practices among hospitals have a significant impact on adverse events. This reinforces the need to develop data-processing tools that enable better monitoring of quality of care.

Mapping the QLQ-C30 quality of life cancer questionnaire to EQ-5D patient preferences.

BACKGROUND: Although cancer-specific Health-Related Quality of Life (HRQOL) are commonly included in randomized clinical trials or other prospective non-randomized clinical studies, it is rare that preference-based instruments are used that allow the calculation of a utility weight suitable for estimating quality-adjusted life-years gained. OBJECTIVE: To develop a mapping algorithm to transform the EORTC QLQ-C30 questionnaire responses into EQ-5D derived utilities. STUDY DESIGN: Retrospective data analysis of a multicentre, multicountry prospective clinical trial in breast cancer patients. METHODS: Regression analysis of individual pairs of EQ-5D and QLQ-C30 scores. RESULTS: A model that explained 80% of the variance was developed to estimate EQ-5D Utilities from QLQ-C30 scores at individual level. From this reliable group level means and deviations can be derived. CONCLUSIONS: Mapping from QLQ-C30 scores to EQ-5D-derived utilities when only QLQ-C30 data are available has been shown to be possible with good accuracy. Validation of the proposed algorithm in other external clinical datasets should be encouraged.

Cost-effectiveness analysis of FDG PET-CT in the management of pulmonary metastases from malignant melanoma.

OBJECTIVES: Most guidelines consider FDG PET-CT to detect occult extra-pulmonary disease prior to lung metastasectomy. A cost-effectiveness analysis, using a Markov model over a 10 year period, was performed to compare two different surveillance programs, either PET-CT or whole-body CT, in patients with suspected pulmonary metastasised melanoma. METHODS: Data from published studies provided probabilities for the model. Complication and care costs were obtained from standardised administrative databases from 19 hospitals identified by DRG codes (reported in 2009 Euros). For the cost calculation of PET-CT we performed a microcosting analysis. All costs and benefits were yearly discounted at respectively 3% and 1.5%. Outcomes included life-months gained (LMG) and the number of futile surgeries avoided. Cost-effectiveness ratios were in Euros per LMG. Univariate and probabilistic sensitivity analyses addressed uncertainty in all model parameters. RESULTS: The PET-CT strategy provided 86.29 LMG (95% CI: 81.50-90.88 LMG) at a discounted cost of euro3,974 (95% CI: euro1,339-12,303), while the conventional strategy provided 86.08 LMG (95% CI: 81.37-90.68 LMG) at a discounted cost of euro5,022 (95% CI: euro1,378-16,018). This PET-CT strategy resulted in a net saving of euro1,048 with a gain of 0.2 LMG. Based on PET-CT findings, 20% of futile surgeries could be avoided. CONCLUSION: Integrating PET-CT in the management of patients with high risk MM appears to be less costly and more accurate by avoiding futile thoracotomies in one of five patients as well as by providing a small survival benefit at 10 years.

Economic impact of non-persistence to antidepressant therapy in the Quebec community-dwelling elderly population.

BACKGROUND: In a real-life setting, differences across newer antidepressants in patterns of use remain poorly explored, particularly in the older patients despite the high prevalence of late-life depression. METHODS: An observational retrospective cohort study was conducted in the community-dwelling elderly population of Quebec using health databases to compare the newer antidepressants with respect to non-persistence, associated health care costs and cost/persistence ratio. A random sample of 12,825 outpatients who initiated an antidepressant treatment in 2000 were followed for 12 months. Non-persistence was defined as treatment duration of less than 180 days. Economic variables included direct costs of prescribed medications, medical services and hospitalizations assessed through RAMQ claims databases and Med-Echo hospitalization database. Cost/persistence ratio and incremental cost/persistence ratio were obtained for each antidepressant product; persistence being considered as an indicator of effectiveness. RESULTS: 55.6% of antidepressant treatments were non-persistent. Products associated with low antidepressant costs were often associated with high costs of other medications and health care services, and vice versa. Paroxetine was associated with the lowest non-persistence (50.5%; 95%CI 48.5-52.5) and one of the most favourable cost/persistence ratios (CDN$4869 per persistent treatment). Fluoxetine was associated with the most favourable incremental cost/persistence ratio. LIMITATIONS: Some services and hospitalizations are not included in the administrative databases. No data on indication for treatment were available. These were likely to be non-differential across newer antidepressants. CONCLUSION: As found in other populations, non-persistence with antidepressant treatment is very frequent in the Quebec elderly population. Products associated with poor persistence result in increased health care costs. Hence, intervention programs aimed at improving persistence would optimize the use of health care resources and result in economic advantages.

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.

The costs of colonoscopy in a Canadian hospital using a microcosting approach.

BACKGROUND: Colonoscopy has become accepted as one of the most effective methods of screening patients for colorectal cancer, and is used to remove the majority of colonic adenomas. OBJECTIVE: Because of the paucity of such estimates in the literature and the significant number of candidates for this procedure, the present study was performed to estimate the direct hospital costs of both diagnostic and therapeutic (polypectomy) colonoscopy. METHODS: A microcosting methodology was used to itemize the costs of colonoscopy. Variable and fixed costs were divided into labour, supplies, equipment and overhead costs. A third-party payer perspective was adopted. All costs are expressed in 2007 Canadian dollars. RESULTS: The cost of a diagnostic colonoscopy was $157 and the cost of a therapeutic colonoscopy was $199. Overhead costs represented approximately 30% of these amounts. When physician fees were added, these costs rose to $352 and $467, respectively. CONCLUSION: Because the overhead costs represent a large proportion of the total costs, allocation methods for these costs should be improved to allow for a more precise determination of the total costs of a colonoscopy. These estimates are useful when analyzing the cost-effectiveness of a strategy that uses colonoscopy when screening for colorectal cancer.

Assessing the quality of pharmacological treatments from administrative databases: the case of low-molecular-weight heparin after major orthopaedic surgery.

RATIONALE, AIMS AND OBJECTIVES: 'Real world data' are needed to assess the quality of pharmacological treatments in clinical practice. The aim of this study was to determine whether administrative databases can be used to assess the quality of prophylaxis with low-molecular-weight heparin after major orthopaedic surgery. METHODS: The study was performed in a Belgian university hospital. Patients undergoing total hip replacement (THR), total knee replacement (TKR) or hip fracture surgery (HFS) were selected retrospectively from the hospital's 2002 and 2003 administrative databases. Readmissions during the same year as the procedure were also analysed. Three quality indicators were assessed: incidence of venous thromboembolism (VTE), major bleeding and death; adherence to guidelines; and the costs of care. RESULTS: Although 70% of data were collected from administrative databases, patients' records also had to be examined. During the period studied, VTE and major bleeding events were rare. Patients undergoing HFS were at greater risk of having a pulmonary embolism [Exact odds ratio (OR)=3.78; 95% confidence interval (CI)=1.13-16.22; P=0.03] or of death from any cause (Exact OR=2.15; 95% CI=1.52-infinity; P<0.01) than patients undergoing THR or TKR. The hospital's prophylaxis protocol was not always followed. Half the patients received higher prophylaxis doses than recommended and 11% received lower doses but no impact on adverse events was demonstrated. CONCLUSION: Results show that administrative databases contain enough information to measure the frequency of adverse events but complementary data on patient weight and on non-reimbursed drugs must be extracted from the patients' records to evaluate adherence to guidelines. Our findings stress the need for better integration of information systems.

Cost-effectiveness of temozolomide for the treatment of newly diagnosed glioblastoma multiforme: a report from the EORTC 26981/22981 NCI-C CE3 Intergroup Study.

BACKGROUND: The study aimed to compare the cost-effectiveness of concomitant and adjuvant temozolomide (TMZ) for the treatment of newly diagnosed glioblastoma multiforme versus initial radiotherapy alone from a public health care perspective. METHODS: The economic evaluation was performed alongside a randomized, multicenter, phase 3 trial. The primary endpoint of the trial was overall survival. Costs included all direct medical costs. Economic data were collected prospectively for a subgroup of 219 patients (38%). Unit costs for drugs, procedures, laboratory and imaging, radiotherapy, and hospital costs per day were collected from the official national reimbursement lists based on 2004. For the cost-effectiveness analysis, survival was expressed as 2.5 years restricted mean estimates. The incremental cost-effectiveness ratio (ICER) was constructed. Confidence intervals for the ICER were calculated using the Fieller method and bootstrapping. RESULTS: The difference in 2.5 years restricted mean survival between the treatment arms was 0.25 life-years and the ICER was euro37,361 per life-year gained with a 95% confidence interval (CI) ranging from euro19,544 to euro123,616. The area between the survival curves of the treatment arms suggests an increase of the overall survival gain for a longer follow-up. An extrapolation of the overall survival per treatment arm and imputation of costs for the extrapolated survival showed a substantial reduction in ICER. CONCLUSIONS: The ICER of euro37,361 per life-year gained is a conservative estimate. We concluded that despite the high TMZ acquisition costs, the costs per life-year gained are comparable to accepted first-line treatment with chemotherapy in patients with cancer.