Cognitive impairment and therapeutic response in resistant depression.

OBJECTIVES: Therapeutic response in depression is a major challenge since more than one third of patients are not in remission after two attempts of antidepressant treatment and will present a treatment-resistant depression. In order to better adapt therapeutic strategies for treatment-resistant patients, predictive indicators and markers of therapeutic response still need to be identified. In parallel, patients with depression exhibit disturbances in cognitive functioning. This study aims to describe and compare cognitive performances collected at inclusion of patients presenting treatment-resistant depression who will be responders at 6 months to those of non-responders, and to evaluate the predictive value of cognitive indicators on clinical therapeutic response at 6 months after a therapeutic modification. METHODS: Observational study. Patients were evaluated at the clinical (HDRS and BDI-II) and cognitive levels using standardized tools assessing memory, executive functions, attention, and social cognition, prior to a change in antidepressant treatment. Six months after inclusion, they were reassessed and classified into two groups based on the presence or absence of therapeutic response, defined by a 50% improvement on HDRS and BDI-II. The cognitive scores collected at inclusion were then compared. Additionally, univariate logistic regression models were used. RESULTS: Thirty patients were included in this study. Only 13 could be evaluated at 6 months. Among these patients, four had responded to the new treatment while nine were non-responders. Both groups of patients presented deviant cognitive performances compared to norms on tests evaluating executive functions and attention. Statistical analyses did not reveal any difference between the cognitive performances of responders and non-responders at 6 months. Regression analyses showed no association between cognitive scores and therapeutic response at 6 months. CONCLUSION: Executive functioning plays a significant role in treatment-resistant depression. In order to improve the understanding and identification of subtypes of depression, cognitive indicators should be systematically integrated into future research.

Hidradenitis suppurativa and social disadvantage: A nationwide administrative data study of the French hospitalized population.

BACKGROUND: A lower socioeconomical status (SES) has been reported in patients suffering from hidradenitis suppurative (HS). However, limitations in the available studies prevent drawing definitive conclusions. OBJECTIVES: The objective of this study was to assess the SES of HS patients using a specific SES indicator, the French DEPrivation index (FDep), specifically designed and validated for the French population. METHODS: This cross-sectional cohort study compared the HS hospitalized population with the general hospitalized population without HS. Data were extracted from the French national hospital discharge database, an exhaustive database on all reimbursed hospital stay in the country with a rolling 10-year history (2012-2021). We included all patients aged 7-75 years with at least one stay in a French hospital. A 1:40 propensity score matching, adjusted for age, sex, smoking status and obesity, was performed to create 2 groups of comparable patients. Subgroup analysis was done in the minor (7-17 years) and major (25-75 years) populations independently. RESULTS: In the overall population, we identified 33,880 patients with HS and 24,445,337 patients without HS. After propensity score matching, logistic regression showed a significant association between HS and social disadvantage. There is a 22.5% increased risk of developing HS for individuals being in quintile 5 (the most disadvantaged quintile) versus quintile 1 (the least disadvantaged quintile) (p < 0.0001). After propensity score matching, the logistic regression showed no association between HS and social disadvantage in the 7-17 subgroup. In this minor population, an association between HS and social disadvantage was observed when propensity score matching was performed on age and sex only. CONCLUSIONS: We demonstrate a significant association between HS and low SES in the adult population. In children between 7 and 17, low SES was associated with obesity and tobacco consumption, but not with HS when the populations were matched on these confounding factors.

Occipital Nerve Stimulation for Refractory Chronic Cluster Headache: A Cost-Effectiveness Study.

INTRODUCTION: Occipital nerve stimulation (ONS) is proposed to treat refractory chronic cluster headache (rCCH), but its cost-effectiveness has not been evaluated, limiting its diffusion and reimbursement. MATERIALS AND METHODS: We performed a before-and-after economic study, from data collected prospectively in a nation-wide registry. We compared the cost-effectiveness of ONS associated with conventional treatment (intervention and postintervention period) to conventional treatment alone (preintervention period) in the same patients. The analysis was conducted on 76 rCCH patients from the French healthcare perspective at three months, then one year by extrapolation. Because of the impact of the disease on patient activity, indirect cost, such as sick leave and disability leave, was assessed second. RESULTS: The average total cost for three months was €7602 higher for the ONS strategy compared to conventional strategy with a gain of 0.07 quality-adjusted life-years (QALY), the incremental cost-effectiveness ratio (ICER) was then €109,676/QALY gained. The average extrapolated total cost for one year was €1344 lower for the ONS strategy (p = 0.5444) with a gain of 0.28 QALY (p < 0.0001), the ICER was then €-4846/QALY gained. The scatter plot of the probabilistic bootstrapping had 80% of the replications in the bottom right-hand quadrant, indicating that the ONS strategy is dominant. The average indirect cost for three months was €377 lower for the ONS strategy (p = 0.1261). DISCUSSION: This ONS cost-effectiveness study highlighted the limitations of a short-time horizon in an economic study that may lead the healthcare authorities to reject an innovative strategy, which is actually cost-effective. One-year extrapolation was the proposed solution to obtain results on which healthcare authorities can base their decisions. CONCLUSION: Considering the burden of rCCH and the efficacy and safety of ONS, the demonstration that ONS is dominant should help its diffusion, validation, and reimbursement by health authorities in this severely disabled population.

How Should we Use Multicolumn Spinal Cord Stimulation to Optimize Back Pain Spatial Neural Targeting? A Prospective, Multicenter, Randomized, Double-Blind, Controlled Trial (ESTIMET Study).

BACKGROUND: Recent studies have highlighted multicolumn spinal cord stimulation (SCS) efficacy, hypothesizing that optimized spatial neural targeting provided by new-generation SCS lead design or its multicolumn programming abilities could represent an opportunity to better address chronic back pain (BP). OBJECTIVE: To compare multicolumn vs. monocolumn programming on clinical outcomes of refractory postoperative chronic BP patients implanted with SCS using multicolumn surgical lead. MATERIALS AND METHODS: Twelve centers included 115 patients in a multicenter, randomized, double-blind, controlled trial. After randomization, leads were programmed using only one or several columns. The primary outcome was change in BP visual analogic scale (VAS) at six months. All patients were then programmed using the full potential of the lead up until 12-months follow-up. RESULTS: At six months, there was no significant difference in clinical outcomes whether the SCS was programmed using a mono or a multicolumn program. At 12 months, in all patients having been receiving multicolumn SCS for at least six months (n = 97), VAS decreases were significant for global pain (45.1%), leg pain (55.8%), and BP (41.5%) compared with baseline (p < 0.0001). CONCLUSION: The ESTIMET study confirms the significant benefit experienced on chronic BP by patients implanted with multicolumn SCS, independently from multicolumn lead programming. These good clinical outcomes might result from the specific architecture of the multicolumn lead, giving the opportunity to select initially the best column on a multicolumn grid and to optimize neural targeting with low-energy requirements. However, involving more columns than one does not appear necessary, once initial spatial targeting of the "sweet spot" has been achieved. Our findings suggest that this spatial concept could also be transposed to cylindrical leads, which have drastically improved their capability to shape the electrical field, and might be combined with temporal resolution using SCS new modalities.

Cost-Effectiveness of Drug-Eluting Stents in Elderly Patients With Coronary Artery Disease: The SENIOR Trial.

BACKGROUND: Elderly patients receive bare metal stents instead of drug-eluting stents (DES) to shorten the duration of dual antiplatelet therapy (DAPT). The SENIOR trial compared outcomes between these 2 types of stents combined with a short duration of DAPT. A significant decrease in the number of patients with at least 1 major adverse cardiac and cerebrovascular event (MACCE) was noted in the DES group. OBJECTIVES: The objective of this article was to perform an economic evaluation of the SENIOR trial. METHODS: This evaluation was performed separately in 5 participating countries using pooled patient-level data from all study patients and country-specific unit costs and utility values. Costs, MACCEs, and quality-adjusted life-years (QALYs) were calculated in both arms at 1 year, and an incremental cost-effectiveness ratio was estimated. Uncertainty was explored by probabilistic bootstrapping. RESULTS: A total of 1200 patients underwent randomization. The average total cost per patient was higher in the DES group. The number of MACCEs and average QALYs were not statistically different between the 2 groups. The 1-year incremental cost-effectiveness ratio for each country of reference ranged from €13 752 to €20 511/MACCE avoided and from €42 835 to €68 231/QALY gained. The scatter plots found a wide dispersion, reflecting a large uncertainty surrounding the results. But in each country studied, 90% of the bootstrap replications indicated a higher cost for greater effectiveness for the DES group. Assuming a willingness to pay of €50 000/QALY, there was between a 40% and 50% chance that the use of DES was cost-effective in 4 countries. CONCLUSION: The use of DES instead of bare metal stents combined with a short duration of DAPT in elderly patients induced higher cost for greater effectiveness in each of the 5 countries studied.

Effectiveness and efficiency of teleimaging in the transplantation process: a mixed method protocol.

BACKGROUND: The transplantation process usually takes place without transplant teams being able to use imaging data to assess graft quality. The decision of whether to go get the graft or not is therefore limited and suboptimal. "Cristal images" is a teleimaging project allowing real-time visualization of images of the organs of the donor. The objective of our study is to assess whether the use of a secure teleimaging can improve the effectiveness and efficiency of the procurement and transplantation processes. METHODS: We will use the exhaustive national registry of organ allocation and transplantation, and compare outcomes before the deployment of "Cristal images" (years 2015-2016) and after it becomes operational (years 2018-2019) for heart, lung, liver and kidney transplant in a before-after study, combined with a preference elicitation study. The primary endpoint will be the number of successful organ transplantations. Secondary endpoints will be related to the efficiency of the transplant process (decision making, transportation, cost) and a preference elicitation study will determine the relative preferences of transplant teams towards few "Cristal images"' components or potential developments, which are yet to be determined through a qualitative analysis based on interviews with professionals. DISCUSSION: This study will provide stakeholders data on the efficiency of real-time visualization for transplant teams and identify the levers likely to influence the technology use among these teams. TRIAL REGISTRATION: clinicaltrials.gov: NCT03201224 , 13 June 2017, retrospectively registered.

Early detection and curative treatment of hepatocellular carcinoma: A cost-effectiveness analysis in France and in the United States.

Hepatocellular carcinoma (HCC) is the leading cause of death in patients with cirrhosis. Patients outside clinical trials seldom benefit from evidence-based monitoring. The objective of this study was to estimate the cost-effectiveness of complying with HCC screening guidelines. The economic evaluation compared surveillance of patients with cirrhosis as recommended by the guidelines ("gold-standard monitoring") to "real-life monitoring" from the health care system perspective. A Markov model described the history of the disease and treatment course including current first-line curative treatment: liver resection, radiofrequency ablation (RFA), and liver transplantation. Transition probabilities were derived mainly from two French cohorts, CIRVIR and CHANGH. Costs were computed using French and U.S. tariffs. Effectiveness was measured in life years gained (LYG). An incremental cost-effectiveness ratio (ICER) was calculated for a 10-year horizon and tested with one-way and probabilistic sensitivity analyses. The cost difference between the two groups was $648 ($87,476 in the gold-standard monitoring group vs. $86,829 in the real-life monitoring group) in France and $11,965 ($93,795 vs. $81,829) in the United States. Survival increased by 0.37 years (7.18 vs. 6.81 years). The ICER was $1,754 per LYG in France and $32,415 per LYG in the United States. The health gain resulted from earlier diagnosis and access to first-line curative treatments, among which RFA provided the best value for money. CONCLUSION: Our results indicate that gold-standard monitoring for patients with cirrhosis is cost-effective, attributed to a higher probability of benefiting from a curative treatment and so a higher survival probability. (Hepatology 2017;65:1237-1248).

Cost-effectiveness of lung volume reduction coil treatment in patients with severe emphysema: results from the 2-year follow-up crossover REVOLENS study (REVOLENS-2 study).

BACKGROUND: The REVOLENS study compared lung volume reduction coil treatment to usual care in patients with severe emphysema at 1 year, resulting in improved quality-adjusted life-year (QALY) and higher costs. Durability of the coil treatment benefit and its cost-effectiveness at 2 years are now assessed. METHODS: After one year, the REVOLENS trial's usual care group patients received coil treatment (second-line coil treatment group). Costs and QALYs were assessed in both arms at 2 years and an incremental cost-effectiveness ratio in cost per QALY gained was calculated. The uncertainty of the results was estimated by probabilistic bootstrapping. RESULTS: The average cost of coil treatment in both groups was estimated at €24,356. The average total cost at 2 years was €9655 higher in the first-line coil treatment group (p = 0.07) and the difference in QALY between the two groups was 0.127 (p = 0.12) in favor of first-line coil treatment group. The 2-year incremental cost-effectiveness ratio (ICER) was €75,978 / QALY. The scatter plot of the probabilistic bootstrapping had 92% of the replications in the top right-hand quadrant. CONCLUSION: First-line coil treatment was more expensive but also more effective than second-line coil treatment at 2 years, with a 2-year ICER of €75,978 / QALY. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01822795 .

How to perform a cost-effectiveness analysis with surrogate endpoint: renal denervation in patients with resistant hypertension (DENERHTN) trial as an example.

Whilst much uncertainty exists as to the efficacy of renal denervation (RDN), the positive results of the DENERHTN study in France confirmed the interest of an economic evaluation in order to assess efficiency of RDN and inform local decision makers about the costs and benefits of this intervention. The uncertainty surrounding both the outcomes and the costs can be described using health economic methods such as the non-parametric bootstrap. Internationally, numerous health economic studies using a cost-effectiveness model to assess the impact of RDN in terms of cost and effectiveness compared to antihypertensive medical treatment have been conducted. The DENERHTN cost-effectiveness study was the first health economic evaluation specifically designed to assess the cost-effectiveness of RDN using individual data. Using the DENERHTN results as an example, we provide here a summary of the principle methods used to perform a cost-effectiveness analysis.

Lung Volume Reduction Coil Treatment vs Usual Care in Patients With Severe Emphysema: The REVOLENS Randomized Clinical Trial.

IMPORTANCE: Therapeutic options for severe emphysema are limited. Lung volume reduction using nitinol coils is a bronchoscopic intervention inducing regional parenchymal volume reduction and restoring lung recoil. OBJECTIVE: To evaluate the efficacy, safety, cost, and cost-effectiveness of nitinol coils in treatment of severe emphysema. DESIGN, SETTING, AND PARTICIPANTS: Multicenter 1:1 randomized superiority trial comparing coils with usual care at 10 university hospitals in France. Enrollment of patients with emphysema occurred from March to October 2013, with 12-month follow-up (last follow-up, December 2014). INTERVENTIONS: Patients randomized to usual care (n = 50) received rehabilitation and bronchodilators with or without inhaled corticosteroids and oxygen; those randomized to bilateral coil treatment (n = 50) received usual care plus additional therapy in which approximately 10 coils per lobe were placed in 2 bilateral lobes in 2 procedures. MAIN OUTCOMES AND MEASURES: The primary outcome was improvement of at least 54 m in the 6-minute walk test at 6 months (1-sided hypothesis test). Secondary outcomes included changes at 6 and 12 months in the 6-minute walk test, lung function, quality of life as assessed by St George's Respiratory Questionnaire (range, 0-100; 0 being the best and 100 being the worst quality of life; minimal clinically important difference, ≥4), morbidity, mortality, total cost, and cost-effectiveness. RESULTS: Among 100 patients, 71 men and 29 women (mean age, 62 years) were included. At 6 months, improvement of at least 54 m was observed in 18 patients (36%) in the coil group and 9 patients (18%) in the usual care group, for a between-group difference of 18% (1-sided 95% CI, 4% to ∞; P = .03). Mean between-group differences at 6 and 12 months in the coil and usual care groups were +0.09 L (95% CI, 0.05 L to ∞) (P = .001) and +0.08 L (95% CI, 0.03 L to ∞) (P = .002) for forced expiratory volume in the first second, +21 m (95% CI, -4 m to ∞) (P = .06) and +21 m (95% CI, -5 m to ∞) (P = .12) for 6-minute walk distance, and -13.4 points (95% CI, -8 points to ∞) and -10.6 points (95% CI, -5.8 points to ∞) for St George's Respiratory Questionnaire (1-sided P < .001 for both). Within 12 months, 4 deaths occurred in the coil group and 3 in the usual care group. The mean total 1-year per-patient cost difference between groups was $47,908 (95% CI, $47,879-$48,073) (P < .001); the incremental cost-effectiveness ratio was $782,598 per additional quality-adjusted life-year. CONCLUSIONS AND RELEVANCE: In this preliminary study of patients with severe emphysema followed up for 6 months, bronchoscopic treatment with nitinol coils compared with usual care resulted in improved exercise capacity with high short-term costs. Further investigation is needed to assess durability of benefit and long-term cost implications. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01822795.

Bariatric surgery reduces the incidence of hidradenitis suppurativa in individuals with obesity: results of a nationwide administrative data study in France.

BACKGROUND: Hidradenitis suppurativa (HS) is a systemic inflammatory condition associated with obesity, metabolic syndrome, and environmental factors. Bariatric surgery (BS) is effective in reducing weight and resolving obesity-related medical problems. OBJECTIVES: The aim of this case-control study is to evaluate the effects of BS on the occurrence and recurrence of HS in individuals with obesity. SETTING: Nationwide administrative data study using the French national discharge database. METHODS: We compared 297,776 individuals with obesity and without a history of HS who underwent BS (BS group) with 2,735,930 individuals with obesity who did not receive BS (control group) to assess the incidence of de novo HS. From the same database, we compared hospitalization rates for HS recurrence between 310 individuals with obesity and HS who had BS (HS_BS group) and 3875 individuals with obesity who did not have BS (HS_control group). Propensity score matching using the nearest-neighbor method was implemented to create comparable patient groups. RESULTS: Individuals with obesity and without a history of HS who received BS exhibited a significantly reduced risk of developing de novo HS (RR = .736 [.639; .847]). Among patients with a history of HS, those who underwent BS had a nonsignificantly reduced risk of HS recurrence (RR = .676 [.369; 1.238]) compared with those who did not. CONCLUSION: BS reduces the risk of developing de novo HS and seems to have a protective effect on its recurrence in individuals with obesity, although the latter effect was not statistically significant.

Cost-effectiveness of 82-Rubidium PET myocardial perfusion imaging for the diagnosis of myocardial ischemia depending on the prevalence of coronary artery disease.

BACKGROUND: 82-Rubidium-Positron emission tomography myocardial perfusion imaging (Rb-PET-MPI) offers higher diagnostic performance for the detection of myocardial ischemia compared to Tc-SPECT-MPI. The aim of this economic evaluation was to perform a cost-effectiveness analysis of Rb-PET-MPI versus Tc-SPECT-MPI in patients with suspected myocardial ischemia according to pretest probabilities (PTP) of obstructive coronary artery disease based on the results of the RUBIS Trial. METHODS: Costs and effectiveness were calculated for all patients over 1 year and an incremental analysis of differences in costs and effectiveness in terms of diagnostic accuracy was performed. The uncertainty of the results was estimated using bootstrap. The analysis was conducted from the perspective of the French health care system with a time horizon of 12 months. RESULTS: The average cost of a Rb-PET-MPI-based strategy for the detection of myocardial ischemia was €219 lower than a SPECT-MPI-based strategy (€1192 (± 1834) vs €973 (± 1939), p < 0.01). The one-year incremental cost-effectiveness ratio was negative: - €2730 (money saved per additional accurate diagnosis) in patients presenting PTP > 15% for the Rb-PET-MPI vs. Tc-SPECT-MPI strategy. Analysis of the joint distribution of costs and outcomes found that the Rb-PET-MPI strategy had a 92% probability to be dominant (cost-saving and outcome-improving). CONCLUSIONS: Rb-PET-MPI is cost-effective compared to Tc-SPECT-MPI for the detection of myocardial ischemia in patients with PTP > 15% of obstructive coronary artery disease. TRIAL REGISTRATION: RUBIS Trial registration: NCT01679886, Registered 03 September 2012, https://clinicaltrials.gov/ct2/show/NCT01679886 .

Bariatric surgery reduces the risk of pancreatic cancer in individuals with obesity before the age of 50 years: A nationwide administrative data study in France.

BACKGROUND: Obesity is a well-established risk factor for pancreatic cancer. Bariatric surgery has demonstrated superior results in terms of weight loss and obesity-related comorbidities compared to medical and behavioral treatments. The aim of this study is to evaluate the effect of bariatric surgery on pancreatic cancer incidence in individuals with obesity. METHOD: Individuals with a diagnosis of obesity were retrieved from the French national hospital discharge database. We conducted a cohort study comparing the risk to develop pancreatic cancer in individuals with obesity with and without history of bariatric surgery; the inverse probability of treatment weighting (IPTW) method was performed to assess the uncertainty around the results. Moreover, a subgroup analysis according to age at the time of bariatric surgery was performed to study its impact on the risk of pancreatic cancer. Finally, possible differences depending on the type of bariatric procedure (sleeve gastrectomy vs Roux-en-Y gastric bypass) were also explored. RESULTS: 160,129 (Bariatric Surgery group) and 1,263,804 (control group) patients with 5.2 ± 1.9 and 6.0 ± 1.9 years of follow-up respectively were included. A significant reduced risk to develop pancreatic cancer during follow-up was identified for the bariatric surgery group in the overall population (HR: 0.567). However, this reduced risk was only observed in the 18-50 years group. These results were furtherly confirmed after IPTW analysis. No difference was found between different bariatric procedures. CONCLUSION: Bariatric surgery has a protective effect against pancreatic cancer in the 18-50 years population. High-quality prospective studies are needed to confirm these results.

Clinical and Economic Impact of Bariatric Surgery Post Liver Transplantation: a Nationwide, Population-Based Retrospective Study.

PURPOSE: Prevalence of obesity in liver transplant recipients is increasing with the overall epidemic augmentation of severe obesity, the effects of immunosuppressive drugs, and lifestyle changes which are responsible for de novo obesity development or aggravation of pre-existing obesity. The aim of this study is to analyze the differences in overall mortality, re-hospitalization rate, and hospitalization-related costs between patients undergoing bariatric surgery after liver transplantation and patients undergoing bariatric surgery alone. MATERIALS AND METHODS: Twenty patients with history of liver transplantation who underwent bariatric surgery were analyzed from the French National Hospital Discharge Database. Overall mortality, re-hospitalization rate, length of stay for bariatric procedure, and the costs of bariatric surgery hospitalization and eventual re-hospitalizations were compared to a group of 360,846 patients who underwent bariatric surgery alone from 2010 to 2019. Furthermore, a 1:1 propensity score matching analysis was conducted. RESULTS: Patients with a history of liver transplantation showed an increased risk of overall mortality (HR: 7.66, p = 0.0047) and increased costs of hospitalization for bariatric surgery (8250 ± 4822€ vs 5583 ± 3398€, p = 0.0005). No differences in length of stay, re-hospitalization rate, and costs were found after multivariate analysis. After propensity score matching analysis, a significant increased cost of hospitalization (8250 ± 4822€ vs 6086 ± 1813€, p = 0.0195) still resulted for the liver transplantation group. CONCLUSION: Bariatric surgery represents the best treatment for obesity and its related associated medical problems. Our study highlights an increased risk of overall all-cause mortality and increased costs of hospitalization in this population compared to patients undergoing bariatric surgery alone.

Clinical and Economic Impact of Previous Bariatric Surgery on Liver Transplantation: a Nationwide, Population-Based Retrospective Study.

PURPOSE: The present study aims to determine the impact of previous bariatric surgery (BS) on the length of hospital stay; the incidence of mortality, re-transplantation, and re-hospitalization after LT; and the related economic costs, through the analysis of the French National Health Insurance Information System. MATERIALS AND METHODS: All patients aged > 18 years who underwent LT in France in the period from 2010 to 2019 were included. Thirty-nine patients with a history of BS (study group) were compared with 1798 obese patients without previous BS (control group). RESULTS: At the time of LT, patients with a history of BS were significantly younger than those of the control group and had lower Charlson comorbidity index. Female sex was significantly more represented in the study group. No significant differences were detected between the two groups regarding the postoperative mortality rate after LT (10.3% in the study group versus 8.0% in the control group), long-term mortality (0.038 versus 0.029 person-year of follow-up, respectively), re-transplantation (adjusted hazard ratio (HR) = 2.15, p = 0.2437), re-hospitalization (adjusted analysis, IRR = 0.93, p = 0.7517), and costs of LT hospitalization (73,515 € in the study group versus 65,878 € in the control group). After 1:2 propensity score matching, the duration of the LT hospital stay was significantly longer in the study group (58.3 versus 33.4 days, p = 0.0172). CONCLUSION: No significant differences were detected between patients with previous BS versus obese patients without history of BS undergoing LT concerning the rates of mortality, re-LT, re-hospitalization after LT, and costs of hospitalization and re-hospitalizations.

Impact of Extended Use of Ablation Techniques in Cirrhotic Patients with Hepatocellular Carcinoma: A Cost-Effectiveness Analysis.

BACKGROUND: To evaluate the cost-effectiveness of the extended use of ablation for the treatment of hepatocellular carcinoma (HCC) with cirrhosis in an expert ablation center when compared to the non-extended use of ablation in equivalent tertiary care centers. METHODS: Consecutive cirrhotic patients with non-metastatic HCC, no prior treatment, and referred to three tertiary care centers between 2012 and 2016 were retrospectively identified. The Bondy group, including all of the patients treated at Jean Verdier Hospital, where the extended use of ablation is routinely performed, was compared to the standard of care (SOC) group, including all of the patients treated at the Beaujon and Mondor Hospitals, using propensity score matching. A cost-effectiveness analysis was carried out from the perspective of French health insurance using a Markov model on a lifetime horizon. RESULTS: 532 patients were matched. The Bondy group led to incremental discounted lifetime effects of 0.8 life-years gained (LYG) (95% confidence interval: 0.4, 1.3) and a decrease in lifetime costs of EUR 7288 (USD 8016) (95% confidence interval: EUR 5730 [USD 6303], EUR 10,620 [USD 11,682]) per patient, compared with the SOC group, resulting in a dominant mean incremental cost-effectiveness ratio (ICER). A compliance with the Barcelona Clinic Liver Classification (BCLC) guidelines for earlier stage contributed to the greater part of the ICER. CONCLUSION: The extended use of ablation in cirrhotic patients with HCC was more effective and less expensive than the non-extended use of the ablation strategy.

Do We Need to Assess Quality-of-Life with Both the St George's Respiratory Questionnaire and the EuroQol 5-Dimension Questionnaire in a Clinical Study with an Economic Component: Insights from the REVOLENS Study in Severe Emphysema.

Introduction: The use of two quality-of-life questionnaires in a single clinical trial with an economic component can be challenging due to the associated workload in terms of data collection and an increased risk of missing data. The aim of our study was to determine whether the questionnaire chosen to measure health status, the St. George's Respiratory Questionnaire (SGRQ), could be administered on its own without adding the EuroQol five dimensions questionnaire (EQ-5D) for economic evaluation in emphysema studies. Materials and Methods: Data were prospectively collected during the REVOLENS trial assessing endobronchial coil treatment in severe emphysema. To quantify the association between the two questionnaires, correlations between the EQ-5D and the SGRQ were first tested and the concordance was then studied in order to know whether the two questionnaires were interchangeable. Finally, the Starkie et al algorithm predicting EQ-5D utility values from the SGRQ was used on REVOLENS's individual patient data. The Student's t-test, correlation and concordance between EQ-5D individual value (from the REVOLENS study) and predicted value (from the Starkie et al algorithm) were studied to test this algorithm. Results: Results showed a strong correlation but no concordance between the EQ-5D and the SGRQ, demonstrating that the two questionnaires are not interchangeable. Moreover, the algorithm predicting EQ-5D utilities from the SGRQ did not provide utility values comparable to those observed in the REVOLENS study. Indeed, our study demonstrated a strong correlation between predicted and individual EQ-5D values but no concordance. Conclusion: The use of both the EQ-5D and the SGRQ in a clinical study with an economic component is justified. Based on our results, the SGRQ should not be used to obtain a utility score to calculate the incremental cost-effectiveness ratio and conclude on the efficiency of an intervention in emphysema patients.