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BACKGROUND: A recent meta-analysis concluded that outpatient appendectomy appears feasible and safe, but there is a lack of high-quality evidence and a randomized trial is needed. The aim of this trial is to demonstrate that outpatient appendectomy is non-inferior to conventional inpatient appendectomy in terms of overall morbi-mortality on the 30th postoperative day (D30). METHODS: SAMBA is a prospective, randomized, controlled, multicenter non-inferiority trial. We will include 1400 patients admitted to 15 French hospitals between January 2023 and June 2025. Inclusion criteria are patients aged between 15 and 74 years presenting acute uncomplicated appendicitis suitable to be operated by laparoscopy. Patients will be randomized to receive outpatient care (day-surgery) or conventional inpatient care with overnight hospitalization in the surgery department. The primary outcome is postoperative morbi-mortality at D30. Secondary outcomes include time from diagnosis to appendectomy, length of total hospital stay, re-hospitalization, interventional radiology, re-interventions until D30, conversion from outpatient to inpatient, and quality of life and patient satisfaction using validated questionnaires. DISCUSSION: The SAMBA trial tests the hypothesis that outpatient surgery (i.e., without an overnight hospital stay) of uncomplicated acute appendicitis is a feasible and reliable procedure in establishments with a technical platform able to support this management strategy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05691348. Registered on 20 January 2023.
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Procedimientos Quirúrgicos Ambulatorios , Apendicectomía , Apendicitis , Estudios Multicéntricos como Asunto , Humanos , Apendicectomía/efectos adversos , Apendicectomía/métodos , Procedimientos Quirúrgicos Ambulatorios/efectos adversos , Procedimientos Quirúrgicos Ambulatorios/métodos , Estudios Prospectivos , Apendicitis/cirugía , Apendicitis/mortalidad , Persona de Mediana Edad , Adulto , Adolescente , Anciano , Adulto Joven , Francia , Resultado del Tratamiento , Femenino , Factores de Tiempo , Laparoscopía/efectos adversos , Laparoscopía/métodos , Tiempo de Internación , Masculino , Estudios de Equivalencia como Asunto , Calidad de Vida , Satisfacción del Paciente , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: The use of metabolic and bariatric surgery (MBS) is not uniformly distributed within the population, even if it is governed by established guidelines. This disparity seems to be associated, among other factors, with the economic profile of people receiving this surgery. OBJECTIVES: We investigated the disparities in the use of MBS with respect to the socio-economic level in France based on socio-economic status (SES). MATERIALS AND METHODS: A descriptive observational study was conducted to compare the population of individuals with obesity who underwent MBS (MBS group) with individuals with obesity with no history of MBS (obese group). Data were extracted from the French National Hospital discharge database ("Programme De Médicalisation des Systèmes d'Information," PMSI). Socio-economic status (SES) was assessed through the French Deprivation Index (FDep). RESULTS: The use of MBS was significantly lower in patients having a higher SES compared to those having a lower one. There was no statistically significant difference in the use of MBS between individuals within the 4th and 5th SES quintiles compared to those in the 2nd and 3rd quintiles. No difference was found in the specific MBS procedures used depending on the SES. The obesity level was significantly lower in patients from the 1st and 3rd SES quintiles compared to the patients having a lower SES. CONCLUSION: Our study provides valuable insights into the complex interrelationships between the use of MBS, patients' SES, and obesity levels according to the FDep. These findings underscore the importance of developing targeted interventions to address disparities in the use of bariatric care.
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Cirugía Bariátrica , Obesidad Mórbida , Humanos , Francia , Cirugía Bariátrica/economía , Cirugía Bariátrica/estadística & datos numéricos , Femenino , Masculino , Adulto , Persona de Mediana Edad , Obesidad Mórbida/cirugía , Obesidad Mórbida/economía , Disparidades en Atención de Salud/estadística & datos numéricos , Disparidades en Atención de Salud/economía , Factores SocioeconómicosRESUMEN
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.
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Cirugía Bariátrica , Hidradenitis Supurativa , Obesidad , Humanos , Hidradenitis Supurativa/cirugía , Hidradenitis Supurativa/epidemiología , Hidradenitis Supurativa/complicaciones , Francia/epidemiología , Femenino , Masculino , Adulto , Incidencia , Estudios de Casos y Controles , Obesidad/complicaciones , Obesidad/epidemiología , Obesidad/cirugía , Persona de Mediana Edad , Bases de Datos Factuales , RecurrenciaRESUMEN
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.
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Artritis Psoriásica , Enfermedades del Sistema Nervioso , Psoriasis , Accidente Cerebrovascular , Humanos , Artritis Psoriásica/complicaciones , Artritis Psoriásica/tratamiento farmacológico , Artritis Psoriásica/epidemiología , Psoriasis/complicaciones , Psoriasis/tratamiento farmacológico , Psoriasis/epidemiología , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Atención a la SaludRESUMEN
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.
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Hidradenitis Supurativa , Adulto , Niño , Humanos , Hidradenitis Supurativa/epidemiología , Hidradenitis Supurativa/complicaciones , Estudios Transversales , Obesidad/epidemiología , Obesidad/complicaciones , Tiempo de Internación , Fumar/epidemiologíaRESUMEN
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 .
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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.
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Cirugía Bariátrica , Derivación Gástrica , Obesidad Mórbida , Neoplasias Pancreáticas , Humanos , Persona de Mediana Edad , Obesidad Mórbida/epidemiología , Obesidad Mórbida/cirugía , Estudios de Cohortes , Obesidad/complicaciones , Obesidad/epidemiología , Obesidad/cirugía , Cirugía Bariátrica/métodos , Derivación Gástrica/métodos , Gastrectomía/métodos , Francia/epidemiología , Factores de Riesgo , Neoplasias Pancreáticas/epidemiología , Neoplasias Pancreáticas/cirugía , Resultado del Tratamiento , Estudios RetrospectivosRESUMEN
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.
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Cirugía Bariátrica , Trasplante de Hígado , Obesidad Mórbida , Cirugía Bariátrica/métodos , Mortalidad Hospitalaria , Humanos , Obesidad/etiología , Obesidad/cirugía , Obesidad Mórbida/cirugía , Estudios RetrospectivosRESUMEN
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.
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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.
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Cirugía Bariátrica , Trasplante de Hígado , Obesidad Mórbida , Femenino , Humanos , Tiempo de Internación , Obesidad Mórbida/cirugía , Estudios RetrospectivosRESUMEN
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.
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Cefalalgia Histamínica , Cefalalgia Histamínica/terapia , Análisis Costo-Beneficio , Humanos , Nervios Periféricos , Años de Vida Ajustados por Calidad de VidaRESUMEN
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.
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Síndrome de Fracaso de la Cirugía Espinal Lumbar , Estimulación de la Médula Espinal , Dolor de Espalda/terapia , Humanos , Dimensión del Dolor , Estudios Prospectivos , Médula Espinal , Resultado del TratamientoRESUMEN
OBJECTIVES: Crowding is a frequent concern in the emergency department (ED). Laboratory point-of-care testing (POCT) has been proposed to decrease patients' length of stay (LOS). Our objective was to determine whether an extended panel of POCT solutions could reduce LOS. METHODS: This was a single-center, prospective, open-label, controlled cluster-randomized study. Blood test processing was randomized into 1-week inclusion periods: interventional arm (laboratory analyses performed on POCT analyzers implemented in the ED) or control arm (central laboratory). The primary endpoint was LOS of patients in the ED. Secondary endpoints were time to result (TTR), ED crowding surrogates, and average total cost of an ED visit in each arm. RESULTS: A total of 23,231 patients were included and 20,923 were analyzed for the main outcome measure. Mean ± SD age was 46 ± 20 years, and 7,905 (36%) underwent blood sampling. Mean ± SD LOSs were 203 ± 161 and 210 ± 168 minutes in the POCT and control arms, respectively. LOS reduction for the entire ED population was -9 minutes (95% confidence interval [CI] = -22 to 5, p = 0.22) compared to the control arm and -17 minutes (95% CI = -34.0 to 0.6, p = 0.06) for patients undergoing blood sampling. The mean ± SD TTRs were 28 ± 31 and 79 ± 34 minutes in the POCT and control arms, respectively (TTR reduction = -51 minutes, 95% CI = -54 to -48 minutes, p < 0.001). CONCLUSIONS: The implementation of an extended panel of POCT solutions in an ED did not significantly reduce the LOS, but reduced the TTR.
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Servicio de Urgencia en Hospital/estadística & datos numéricos , Tiempo de Internación/estadística & datos numéricos , Pruebas en el Punto de Atención/estadística & datos numéricos , Adulto , Anciano , Análisis por Conglomerados , Aglomeración , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
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.
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Indicadores de Salud , Pulmón/fisiopatología , Enfisema Pulmonar/diagnóstico , Calidad de Vida , Encuestas y Cuestionarios , Anciano , Algoritmos , Broncoscopía/economía , Broncoscopía/instrumentación , Análisis Costo-Beneficio , Femenino , Francia , Costos de la Atención en Salud , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Prospectivos , Enfisema Pulmonar/economía , Enfisema Pulmonar/fisiopatología , Enfisema Pulmonar/terapia , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del TratamientoRESUMEN
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.
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Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos/economía , Anciano , Análisis de Varianza , Benchmarking , Enfermedad de la Arteria Coronaria/economía , Análisis Costo-Beneficio , Europa (Continente) , Humanos , Años de Vida Ajustados por Calidad de Vida , Método Simple Ciego , Resultado del TratamientoRESUMEN
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.
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Diagnóstico por Imagen/métodos , Trasplante de Órganos/métodos , Telerradiología/métodos , Obtención de Tejidos y Órganos/métodos , Adulto , Anciano , Diagnóstico por Imagen/normas , Francia , Humanos , Persona de Mediana Edad , Trasplante de Órganos/normas , Sistema de Registros , Proyectos de Investigación , Estudios Retrospectivos , Telerradiología/normas , Donantes de Tejidos , Obtención de Tejidos y Órganos/normas , Adulto JovenRESUMEN
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 .
Asunto(s)
Análisis Costo-Beneficio/métodos , Pulmón/patología , Implantación de Prótesis/economía , Enfisema Pulmonar/economía , Enfisema Pulmonar/cirugía , Índice de Severidad de la Enfermedad , Aleaciones/administración & dosificación , Estudios Cruzados , Femenino , Estudios de Seguimiento , Volumen Espiratorio Forzado/fisiología , Humanos , Masculino , Tamaño de los Órganos/fisiología , Estudios Prospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
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.