Saliva microRNA signature to diagnose endometriosis: A cost-effectiveness evaluation of the Endotest®.

OBJECTIVE: To evaluate a saliva diagnostic test (Endotest®) for endometriosis compared with the conventional algorithm. DESIGN: A cost-effectiveness analysis with a decision-tree model based on literature data. SETTING: France. POPULATION: Women with chronic pelvic pain. METHODS: Strategy I is the French algorithm, representing the comparator. For strategy II, all patients have an Endotest®. For strategy III, patients undergo ultrasonography to detect endometrioma and patients with no endometrioma detected have an Endotest®. For strategy IV, patients with no endometrioma detected on ultrasonography undergo pelvic magnetic resonance imaging (MRI) to detect endometrioma and/or deep endometriosis. An Endotest® is then performed for patients with a negative result on MRI. MAIN OUTCOMES MEASURES: Costs and accuracy rates and incremental cost-effectiveness ratios (ICERs). Three analyses were performed with an Endotest® priced at €500, €750, and €1000. Probabilistic sensitivity analysis was conducted with Monte Carlo simulations. RESULTS: With an Endotest® priced at €750, the cost per correctly diagnosed case was €1542, €990, €919 and €1000, respectively, for strategies I, II, III and IV. Strategy I was dominated by all other strategies. Strategies IV, III and II were, respectively, preferred for a willingness-to-pay threshold below €473, between €473 and €4670, and beyond €4670 per correctly diagnosed case. At a price of €500 per Endotest®, strategy I was dominated by all other strategies. At €1000, the ICERs of strategies II and III were €724 and €387 per correctly diagnosed case, respectively, compared with strategy I. CONCLUSION: The present study demonstrates the value of the Endotest® from an economic perspective.

A Real-World Cost-Effectiveness Analysis of Rivaroxaban versus Vitamin K Antagonists for the Treatment of Symptomatic Venous Thromboembolism: Lessons from the REMOTEV Registry.

Background and objectives: Venous thromboembolism (VTE) represents a health and economic burden with consequent healthcare resource utilization. Direct oral anticoagulants (DOACs) have emerged as the mainstay option for VTE treatment but few data exist on their cost-effectiveness as compared to the standard therapy (vitamin K antagonists (VKAs)). This study aimed to assess the cost-effectiveness of rivaroxaban compared to VKAs in VTE treatment by calculating the incremental cost effectiveness ratio (ICER). Materials and methods: We conducted a prospective observational study based on the REMOTEV registry, including patients hospitalized for VTE from 23 October 2013 to 31 July 2015, to evaluate the impact of the anticoagulant treatment (DOACs versus VKAs) on 6-month complications: major or clinically relevant non-major bleeding, VTE recurrence and all-cause death. Rivaroxaban was the only DOAC prescribed in this study. The ICER was calculated as the difference in costs divided by the difference in effectiveness. Results: Among the 373 patients included, 279 were treated with rivaroxaban (63.1 ± 17.9 years old; 49% men) and 94 with VKAs (71.3 ± 16.6 years old; 46% men). The mean cost was EUR 5662 [95% CI 6606; 9060] for rivaroxaban and EUR 7721 [95% CI 5130; 6304] for VKAs, while effectiveness was 0.0586 95% CI [0.0114; 0.126] for DOACs and 0.0638 [95% CI 0.0208; 0.109] for VKAs. The rivaroxaban treatment strategy was dominant with costs per patient EUR 2059 lower [95% CI -3582; -817] and a higher effectiveness of 0.00527 [95% CI -0.0606; 0.0761] compared to VKAs. Conclusions: This study provides real-world evidence that rivaroxaban is not only an efficient and safe alternative to VKAs for eligible VTE patients, but also cost-saving.

A Real-World Cost-Effectiveness Study Evaluating Imaging Strategies for the Diagnostic Workup of Renal Colic in the Emergency Department.

Introduction Both non-contrast Computed Tomography (CT) and ultrasound (US) are used for the diagnosis of renal colic in the emergency department (ED). Although US reduces radiation exposure, its diagnostic accuracy is inferior to that of CT. In this context, data regarding the cost and organizational impact of these strategies represent essential elements in the choice of imaging; however, they remain poorly documented. Aim of the study The aim of this study was to compare the costs and effectiveness of diagnostic workup by US and CT for patients consulting with renal colic in the ED. Methods We conducted a monocentric real-life retrospective study of patients consulting for a renal colic in an ED between 1 July 2018 and 31 December 2018. We estimated length of stay (LOS), total hospital costs at 60 days including ED, and initial and repeat admissions. Patients with initial US in the ED were compared to patients with initial CT using inverse probability weighting of the propensity score calculated from demographic variables, vital parameters, and clinical presentation. We calculated the incremental cost effectiveness ratio as the difference in costs by the difference in LOS. The variability of the results was assessed using non-parametric bootstrapping. Results In this study, of the 273 patients included, 67 were patients assessed with US and 206 with CT. The average costs were €1159 (SD 1987) and €956 (SD 1462) for US and CT, respectively, and the ED LOS was 8.9 [CI 95% 8.1; 9.4] and 8.7 [CI 95% 7.9; 9.9] hours for US and CT, respectively. CT was associated with a decreased LOS by 0.139 [CI 95% -1.1; 1.5] hours and was cost-saving, with a €199 [CI 95% -745; 285] reduction per patient. Conclusion When imaging is required in the ED for suspected renal colic as recommended, there is real-life evidence that CT is a cost-effective strategy compared to US, reducing costs and LOS in the ED.

MRI dedicated to the emergency department for diplopia or dizziness: a cost-effectiveness analysis.

OBJECTIVES: The purpose of this study was to compare the costs and organizational benefits of diagnostic workup without and with MRI dedicated to the ED. METHODS: We conducted a prospective observational uncontrolled before-after study in one ED of a university hospital in France from July 1, 2018, and January 3, 2020. We included all consecutive patients presenting with dizziness or diplopia. The main outcomes were the clinical decision time of ED physicians and the total costs for each strategy. Outcomes were compared using propensity score with inverse probability weighting in the 2 arms and an incremental cost-effectiveness ratio (ICER) was calculated. RESULTS: Among the 199 patients during the "before" period (average age: 60.4 years ± 17.6): 112 men (57%), and 181 during the "after" period (average age, 54.8 years ± 18.5): 107 men (59%), the average costs were €2701 (95% CI 1918; 3704) and €2389 (95% CI: €1627; 3280) per patient, respectively. The average time to clinical decision was 9.8 h (95% CI: 8.9 10.7) in the group "before" and 7.7 h (95% CI: 7.1; 8.4) in the group "after" (ICER: €151 saved for a reduction of 1 h in clinical decision time). The probabilistic sensitivity analysis estimated a 71% chance that the MRI dedicated to ED was dominant (less costly and more effective). CONCLUSION: Easy access to MRI in the ED for posterior circulation stroke-like symptoms must be considered a relevant approach to help physicians for an appropriate and rapid diagnostic with reduction of costs. TRIAL REGISTRATION: NCT03660852 KEY POINTS: • A dedicated MRI in the ED for diplopia or dizziness may be considered an efficient strategy improving diagnostic performance, reducing physicians' decision time, and decreasing hospital costs. • This strategy supports clinical decision-making with early treatment and management of patients with posterior circulation-like symptoms in the ED. • There is 71% chance that the MRI dedicated to ED was dominant (less costly and more effective) compared with a strategy without dedicated MRI.

Effectiveness and cost-effectiveness of a telemedicine programme for preventing unplanned hospitalisations of older adults living in nursing homes: the GERONTACCESS cluster randomized clinical trial.

OBJECTIVE: The GERONTACCESS trial evaluated the utility and cost-effectiveness of a gerontological telemedicine (TLM) programme for preventing unplanned hospitalisation of residents living in nursing homes (NHs) in regions lacking medical facilities and/or qualified medical providers ("medical deserts"). DESIGN: GERONTACCESS was a 12-month, multicentre, prospective cluster-randomised trial conducted in NHs. The intervention group underwent TLM assessments every 3 months. The control group received the usual care. In both groups, comprehensive on-site assessments were conducted at baseline and the final visit. Care requirements were documented throughout the study. SETTING AND PARTICIPANTS: NH residents aged ≥ 60 years with multiple chronic diseases. METHODS: The study outcomes were the proportion of patients who experienced avoidable and unplanned hospitalisation, and the incremental cost savings per quality-adjusted life years from baseline to the 12-month follow-up. RESULTS: Of the 426 randomised participants (mean ± standard deviation age, 87.2 ± 7.6 years; 311 [73.0%] women), 23.4% in the intervention group and 32.5% in the control group experienced unplanned hospitalisation (odds ratio [OR] = 0.73, 95% confidence interval [CI] 0.43 to 0.97; p = 0.034). Each avoided hospitalisation in the intervention group saved $US 3,846. CONCLUSIONS AND IMPLICATIONS: The results of GERONTACCESS revealed that our gerontological, preventative TLM program significantly reduced unplanned hospitalisations. This innovative intervention limited disease progression and promoted a healthy lifestyle among NH residents. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02816177, registered June 28, 2016.

Epidemiology and prognostic factors of pleural empyema.

BACKGROUND: Infection of the pleural cavity invariably leads to hospitalisation, and a fatal outcome is not uncommon. Our aim was to study the epidemiology of pleural empyema on a nationwide basis in the whole population and in three subgroups of patients, namely post-lung resection, associated cancer and those with no surgery and no cancer. METHODS: Data from patients aged ≥18 years hospitalised with a diagnosis of pleural infection in France between January 2013 and December 2017 were retrieved from the medical-administrative national hospitalisation database and retrospectively analysed. Mortality, length of stay and costs were assessed. RESULTS: There were 25 512 hospitalisations for pleural empyema. The annual rate was 7.15 cases per 100 000 habitants in 2013 and increased to 7.75 cases per 100 000 inhabitants in 2017. The mean age of patients was 62.4±15.6 years and 71.7% were men. Post-lung resection, associated cancer and no surgery-no cancer cases accounted for 9.8%, 30.1% and 60.1% of patients, respectively. These groups were significantly different in terms of clinical characteristics, mortality and risk factors for length of stay, costs and mortality. Mortality was 17.1% in the whole population, 29.5% in the associated cancer group, 17.7% in the post-lung resection group and 10.7% in the no surgery-no cancer group. In the whole population, age, presence of fistula, higher Charlson Comorbidity Index (>3), alcohol abuse, arterial hypertension, hyperlipidaemia, atheroma, atrial fibrillation, performance status >3 and three subgroups of pleural empyema independently predicted mortality. CONCLUSIONS: Empyema is increasing in incidence. Factors associated with mortality are recent lung resection and associated diagnosis of cancer.

Cost-effectiveness analysis of pretreatment screening for NUDT15 defective alleles.

BACKGROUND: Nucleotide triphosphate diphosphatase (NUDT15) genetic testing in addition to thiopurine methyl transferase (TPMT) is recommended to reduce the incidence of adverse severe myelotoxicity episodes induced by thiopurines. OBJECTIVE: We assessed the cost-effectiveness ratio of combined screening for TMPT and NUDT15 defective alleles by genotyping or next-generation sequencing (NGS) using TPMT genotyping as the reference. Because of the genetic differences in thiopurine toxicity, we tested the screening strategies on individuals of Caucasian and Asian descent. METHODS: A decision tree compared conventional TPMT genotyping with combined TPMT/NUDT15 genotyping or NGS using a Monte-Carlo microsimulation model of patients with inflammatory bowel disease. The main outcome was the incremental cost-effectiveness ratios (ICER) with effectiveness being one averted severe myelotoxicity requiring hospitalization. RESULTS: The mean estimated cost of the TPMT genotyping for one year is twice in Asian compared with Caucasian patients (980 euro/patient versus 488 euro/patient), and the effectiveness of TPMT genotyping in Caucasian avoided 43 severe myelosuppressions per 10 000 patients over a year compared with 3.6 per 10 000 patients in Asian. Combined TPMT/NUDT15 genotyping compared with TPMT genotyping had an ICER of 7 491 281 euro per severe myelotoxicity averted in Caucasian, compared to 619 euro in Asian. The ICER of the NGS-based screening strategy is disproportionally high compared with genotyping, irrespective of ethnic descent. CONCLUSION: With a low cost-effectiveness threshold, combined screening for NUDT15 and TPMT defective alleles is cost-effective compared to TMPT screening alone in patients of Asian descent, but is unrealistic from a cost-effectiveness point of view in Caucasians.

Comparison of 18F-sodium fluoride PET/CT, 18F-fluorocholine PET/CT and diffusion-weighted MRI for the detection of bone metastases in recurrent prostate cancer: a cost-effectiveness analysis in France.

BACKGROUND: The diagnostic performance of 18F-sodium fluoride positron emission tomography/computed tomography (PET/CT) (NaF), 18F-fluorocholine PET/CT (FCH) and diffusion-weighted whole-body magnetic resonance imaging (DW-MRI) in detecting bone metastases in prostate cancer (PCa) patients with first biochemical recurrence (BCR) has already been published, but their cost-effectiveness in this indication have never been compared. METHODS: We performed trial-based and model-based economic evaluations. In the trial, PCa patients with first BCR after previous definitive treatment were prospectively included. Imaging readings were performed both on-site by local specialists and centrally by experts. The economic evaluation extrapolated the diagnostic performances of the imaging techniques using a combination of a decision tree and Markov model based on the natural history of PCa. The health states were non-metastatic and metastatic BCR, non-metastatic and metastatic castration-resistant prostate cancer and death. The state-transition probabilities and utilities associated with each health state were derived from the literature. Real costs were extracted from the National Cost Study of hospital costs and the social health insurance cost schedule. RESULTS: There was no significant difference in diagnostic performance among the 3 imaging modalities in detecting bone metastases. FCH was the most cost-effective imaging modality above a threshold incremental cost-effectiveness ratio of 3000€/QALY when imaging was interpreted by local specialists and 9000€/QALY when imaging was interpreted by experts. CONCLUSIONS: FCH had a better incremental effect on QALY, independent of imaging reading and should be preferred for detecting bone metastases in patients with biochemical recurrence of prostate cancer. TRIAL REGISTRATION: NCT01501630. Registered 29 December 2011.

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.

Telepsychiatry for Children and Adolescents: A Review of the PROMETTED Project.

BACKGROUND: Telemedicine for children and adolescents is a public health topic, and since 2009 in France, the legal framework defines practical modalities. Some children with Attention Deficit with or without Hyperactivity Disorder, social anxiety, or Autism Spectrum Disorder (ASD) can be easily engaged within a teleconsultation model. Literature suggests new opportunities to facilitate the care process for the ASD person and his family: diagnosis with the use of validated instruments and parental accompaniment. METHODS: Since 2015, a pilot project called PROMETTED was supported by the Regional Health Agency of Ile de France. It was developed and managed by the team of the Center for Diagnosis and Evaluation for Autism (CDEA) of Sainte-Anne Hospital and associated PEDIATED, the CDEA of Versailles. RESULTS: Five medico-social structures for children and adolescents with ASD and the two CDEAs co-elaborated a scheme of intervention with telemedicine. The remote evaluation is a four-step process structured around the medical history and the observation of the young subject; the Autism Diagnostic Interview; the use of the Childhood Autism Rating Scale and the Vineland Adaptive Behavior Scales; and feedback to parents. CONCLUSIONS: Medico-economic and satisfaction evaluations are in progress.

Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials.

BACKGROUND: With the development of information and communication technologies, telemedicine has been proposed as a way to improve patient management by facilitating access to appropriate diagnosis and treatment. The Paris Ile de France Regional Health Agency is currently funding a comprehensive program of telemedicine experiments. This article describes the protocols for the evaluation of the implementation of telemedicine in the Paris region. METHODS/DESIGN: Over 2,500 patients have been included in eight studies addressing the use of telemedicine in the context of specific diseases or settings. Two projects are randomized controlled trials, while the six other projects are based on before-after designs (differences in differences studies). Based on the MAST model and the French national framework, we identified endpoints to assess the impact of telemedicine on five dimensions: clinical effectiveness, cost-effectiveness, security of the application, patient satisfaction and quality of life and perception of professionals. DISCUSSION: Telemedicine encompasses a wide range of services and stakeholders, and thus study protocols must be tailored to the specific constraints and interests of the users. TRIAL REGISTRATION: NCT02110433 (03/07/2014), NCT02157740 (05/27/2014), NCT02374697 (02/05/2015), NCT02157727 (05/27/2014), NCT02229279 (08/28/2014), NCT02368769 (02/05/2015), NCT02164747 (NCT02164747), NCT02309905 (11/27/2014).

Implementing Technologies: Assessment of Telemedicine Experiments in the Paris Region: Reasons for Success or Failure of the Evaluations and of the Deployment of the Projects.

BACKGROUND: Telemedicine is increasingly viewed as a tool to provide a wide range of health services. This article presents policy lessons drawn from the evaluation of telemedicine experiments conducted in the Paris region. METHODS: We used a mixed method design to study telemedicine projects commissioned by the Paris Regional Health Agency between 2013 and 2017. We combined data analysis of the telemedicine projects, review of the protocols, and interviews with stakeholders. RESULTS: We identified the following reasons for disappointing outcomes: the outcome measure was requested too early during the experiments because payers required information for budgetary decisions; and the learning curve, technical problems, diversion of use, insufficient number of inclusions, and a lack of adherence prevented the demonstration of successful outcomes of the projects. CONCLUSION: The evaluation of telemedicine should be undertaken after sufficient uptake to ensure barriers to implementation are overcome, and to obtain the sample size necessary for statistical power and reduce the average cost for one telemedicine request. Randomized controlled trials should be encouraged with appropriate funding and the follow-up period should be extended.

Impact of the switch from four to three intradermal rabies post-exposure prophylaxis sessions in patients bitten by dogs: A cost-consequence analysis from the patients' perspective.

The annual incidence of rabies deaths has been estimated in Cambodia at nearly 5.8/100,000 person-years. The cost of post exposure prophylaxis (PEP) and travel is potentially a significant barrier for exposed patients and their families, although safety nets are in place to provide the prophylaxis at no cost for low-income families. A decision-tree model was built to estimate changes in the costs from the patients' perspective and the survival outcomes of the Institut Pasteur du Cambodge (IPC) rabies PEP regimen after the switch from the Thai Red Cross (TRC) rabies PEP regimen in patients exposed to WHO category II or III bites by dogs. Derived from the IPC database, data included the trajectory of 203,497 patients, 1412 called-back patients and economic data on 201 patients. Uncertainty was addressed using one-way and probabilistic sensitivity analyses. Compared to the TRC regimen, the IPC regimen was cheaper and equally effective in patients with category II bites. In patients with category III bites, the IPC regimen was cheaper and its modeled probability of survival was 0.04% (95% CI, -0.12%; 0%) lower than the TRC regimen. However, the mortality rate was very low and the causes of death were uncertain. The data available may have lacked power to be able to statistically significantly tell apart the difference between genuine PEP failure and incorrect PEP administration, in the three versus the four-PEP sessions.

Association between mental disorders and COVID-19 outcomes among inpatients in France: A retrospective nationwide population-based study.

BACKGROUND: Mental disorders are at-risk of severe COVID-19 outcomes. There is limited and heterogeneous national data in hospital settings evaluating the risks associated with any pre-existing mental disorder, and susceptible subgroups. Our study aimed to investigate the association between pre-existing psychiatric disorders and outcomes of adults hospitalised for COVID-19. METHOD: We used data obtained from the French national hospital database linked to the state-level psychiatric registry. The primary outcome was 30-days in-hospital mortality. Secondary outcomes were to compare the length of hospital stay, Intensive Care Unit (ICU) admission and ICU length. Propensity score matching analysis was used to control for COVID-19 confounding factors between patients with or without mental disorder and stratified by psychiatric subgroups. RESULTS: Among 97 302 adults hospitalised for COVID-19 from March to September 2020, 10 083 (10.3%) had a pre-existing mental disorder, mainly dementia (3581 [35.5%]), mood disorders (1298 [12.9%]), anxiety disorders (995 [9.9%]), psychoactive substance use disorders (960 [9.5%]), and psychotic disorders (866 [8.6%]). In propensity-matched analysis, 30-days in-hospital mortality was increased among those with at least one pre-existing mental disorder (hazard ratio (HR) 1.15, 95% CI 1.08-1.23), psychotic disorder (1.90, 1.24-2.90), and psychoactive substance disorders (1.53, 1.10-2.14). The odds of ICU admission were consistently decreased for patients with any pre-existing mental disorder (OR 0.83, 95% CI 0.76-0.92) and for those with dementia (0.64, 0.53-0.76). CONCLUSION: Pre-existing mental disorders were independently associated with in-hospital mortality. These findings underscore the important need for adequate care and targeted interventions for at-risk individuals with severe mental illness.

Early hepatocellular carcinoma detection using magnetic resonance imaging is cost-effective in high-risk patients with cirrhosis.

BACKGROUND & AIMS: Reinforced hepatocellular carcinoma (HCC) surveillance using magnetic resonance imaging (MRI) could increase early tumour detection but faces cost-effectiveness issues. In this study, we aimed to evaluate the cost-effectiveness of MRI for the detection of very early HCC (Barcelona Clinic Liver Cancer [BCLC] 0) in patients with an annual HCC risk >3%. METHODS: French patients with compensated cirrhosis included in 4 multicentre prospective cohorts were considered. A scoring system was constructed to identify patients with an annual risk >3%. Using a Markov model, the economic evaluation estimated the costs and life years (LYs) gained with MRI vs. ultrasound (US) monitoring over a 20-year period. The incremental cost-effectiveness ratio (ICER) was calculated by dividing the incremental costs by the incremental LYs. RESULTS: Among 2,513 patients with non-viral causes of cirrhosis (n = 840) and/or cured HCV (n = 1,489)/controlled HBV infection (n = 184), 206 cases of HCC were detected after a 37-month follow-up. When applied to training (n = 1,658) and validation (n = 855) sets, the construction of a scoring system identified 33.4% and 37.5% of patients with an annual HCC risk >3% (3-year C-Indexes 75 and 76, respectively). In patients with a 3% annual risk, the incremental LY gained with MRI was 0.4 for an additional cost of €6,134, resulting in an ICER of €15,447 per LY. Compared to US monitoring, MRI detected 5x more BCLC 0 HCC. The deterministic sensitivity analysis confirmed the impact of HCC incidence. At a willingness to pay of €50,000/LY, MRI screening had a 100% probability of being cost-effective. CONCLUSIONS: In the era of HCV eradication/HBV control, patients with annual HCC risk >3% represent one-third of French patients with cirrhosis. MRI is cost-effective in this population and could favour early HCC detection. LAY SUMMARY: The early identification of hepatocellular carcinoma in patients with cirrhosis is important to improve patient outcomes. Magnetic resonance imaging could increase early tumour detection but is more expensive and less accessible than ultrasound (the standard modality for surveillance). Herein, using a simple score, we identified a subgroup of patients with cirrhosis (accounting for >one-third), who were at increased risk of hepatocellular carcinoma and for whom the increased expense of magnetic resonance imaging would be justified by the potential improvement in outcomes.

Imaging strategies used in emergency departments for the diagnostic workup of COVID-19 patients during the first wave of the pandemic: a cost-effectiveness analysis.

OBJECTIVES: Emergency departments (EDs) were on the front line for the diagnostic workup of patients with COVID-19-like symptoms during the first wave. Chest imaging was the key to rapidly identifying COVID-19 before administering RT-PCR, which was time-consuming. The objective of our study was to compare the costs and organizational benefits of triage strategies in ED during the first wave of the COVID-19 pandemic. METHODS: We conducted a retrospective study in five EDs in France, involving 3712 consecutive patients consulting with COVID-like symptoms between 9 March 2020 and 8 April 2020, to assess the cost effectiveness of imaging strategies (chest radiography, chest computed tomography (CT) scan in the presence of respiratory symptoms, systematic ultra-low-dose (ULD) chest CT, and no systematic imaging) on ED length of stay (LOS) in the ED and on hospital costs. The incremental cost-effectiveness ratio was calculated as the difference in costs divided by the difference in LOS. RESULTS: Compared with chest radiography, workup with systematic ULD chest CT was the more cost-effective strategy (average LOS of 6.89 hours; average cost of €3646), allowing for an almost 4-hour decrease in LOS in the ED at a cost increase of €98 per patient. Chest radiography (extendedly dominated) and RT-PCR with no systematic imaging were the least effective strategies, with an average LOS of 10.8 hours. The strategy of chest CT in the presence of respiratory symptoms was more effective than the systematic ULD chest CT strategy, with the former providing a gain of 37 minutes at an extra cost of €718. DISCUSSION: Systematic ULD chest CT for patients with COVID-like symptoms in the ED is a cost-effective strategy and should be considered to improve the management of patients in the ED during the pandemic, given the need to triage patients.

The effect of heterogeneity on HIV prevention trials.

BACKGROUND: Randomized controlled trials (RCTs) for the prevention of HIV heterosexual acquisition are usually conducted among adult African populations with high heterogeneity in individual risk of infection. PURPOSE: The objectives were to (a) review how this heterogeneity has been considered when designing and interpreting such RCTs, (b) evaluate its effect on the findings and the statistical power of these trials, and (c) assess the potential advantages of using the crossover design with single failure-time endpoint. METHODS: Individual-level HIV prevention RCTs conducted in Africa and published in the period 1998-2008 were reviewed. Using Monte Carlo simulations and statistical calculations, we assessed the effect of heterogeneity on the findings and the statistical power of HIV prevention RCTs. RESULTS: All reviewed RCTs used the parallel design. The heterogeneity in individual risk of infection within study sites was not used for stratification nor generally considered in the design and interpretation of RCTs. Simulations showed that in the context of high HIV incidence, high heterogeneity can lead to a substantial underestimation of the impact of an intervention and reduced statistical power. Calculations demonstrated that the crossover design allowed for similar or better estimation and statistical power. The crossover design has the ethical advantage of sharing the potential benefits and risks of the intervention between participants. LIMITATIONS: Only trials with two treatment arms and two follow-up periods were modeled. The baseline risk of infection of each participant was assumed to be constant over time and HIV status was assessed at the end of each follow-up period. CONCLUSIONS: The heterogeneity in individual risk of HIV infection is an underestimated problem which should be taken into account when designing and interpreting RCTs that test prevention methods of HIV heterosexual acquisition in adult African populations with high HIV incidence. When the effects of tested interventions are rapidly reversible, the use of the crossover design should be considered.

High-risk human papillomavirus is associated with HIV acquisition among South African female sex workers.

BACKGROUND: Mounting evidence suggests an association between human papillomavirus (HPV) and HIV acquisition. This study aimed to explore this association among South African female sex workers (FSWs). METHODS: We used data from 88 HIV-negative FSWs who participated in a vaginal gel (COL-1492) trial. Cervicovaginal rinse samples, obtained before HIV-seroconversion, were genotyped into high-risk (HR-) and low-risk (LR-) HPV. HIV-adjusted hazard ratios (aHRs) and 95% confidence intervals (CI) were estimated using Cox survival analysis. RESULTS: HR- and LR-HPV prevalences were 70.5% (95% CI:60.5-79.2) and 60.2% (95% CI:49.9-70.0), respectively. Twenty-five women HIV seroconverted. Controlling for background characteristics and other sexually transmitted infections, HIV aHR increased by a factor of 1.7 (95% CI:1.01-2.7, P(linear trend) = 0.045) for an increase of one unit of the number of HR-HPV genotypes. CONCLUSIONS: HIV seroconversion among FSWs is associated with genital HR-HPV infection. Further investigation is warranted, including testing the possible protective effect of available HPV vaccines on HIV acquisition.

Cost-Utility Analysis of Transarterial Radioembolization With Yttrium-90 Resin Microspheres Compared With Sorafenib in Locally Advanced and Inoperable Hepatocellular Carcinoma.

PURPOSE: The SARAH (Sorafenib Versus Radioembolization in Advanced Hepatocellular Carcinoma) trial (ClinicalTrials.gov Identifier NCT01482442) did not show a significant survival benefit for patients treated with transarterial radioembolization (TARE) compared with continuous oral sorafenib. The improved toxicity profile of patients treated with TARE in the trial, however, could result in a quality of life benefit in economic evaluations. Our objective was to perform a cost-utility analysis of TARE versus sorafenib for locally advanced and inoperable hepatocellular carcinoma. METHODS: This study used patient-level data of the SARAH trial regarding resource use, progression-free and overall survival, and quality of life for the within-trial period for the patients who received at least 1 dose of sorafenib or 1 treatment with TARE according to their randomization arm. Data were extrapolated by using a partitioned survival model that incorporated costs and health outcomes, measured in life-years and quality-adjusted life-years (QALYs). FINDINGS: The use of TARE resulted in an average loss of 0.036 life-year and a gain of 0.006 QALY compared with sorafenib. The aerage cost for the TARE arm was €17,179 (95% CI, 9,926-24,280) higher than the sorafenib arm, for an incremental cost-effectiveness ratio of €3,153,086/QALY. The probabilistic sensitivity analysis revealed a 50% risk that the TARE strategy was dominated. TARE was consistently dominated by sorafenib or had an incremental cost-effectiveness ratio more than €450,000/QALY in all sensitivity analyses. IMPLICATIONS: This economic evaluation of SARAH found that using radioembolization with yttrium-90 microspheres for the treatment of hepatocellular carcinoma was not a cost-effective option at the usually accepted willingness-to-pay thresholds.

The Impact of Previous History of Bariatric Surgery on Outcome of COVID-19. A Nationwide Medico-Administrative French Study.

PURPOSE: To determine the risk of invasive mechanical ventilation and death in obese individuals with a history of bariatric surgery (BS) admitted for COVID-19. METHODS: All obese inpatients recorded during a hospital stay by the French National Health Insurance were included, and their electronic health data were reviewed retrospectively. Patients who had undergone bariatric surgery comprised the BS group and patients with obesity but no history of BS served as controls. The primary outcome was COVID-19-related death and the secondary outcome was the need for invasive mechanical ventilation. RESULTS: 4,248,253 obese individuals aged 15-75 years were included and followed for a mean observation time of 5.43 ± 2.93 years. 8286 individuals with a previous diagnosis of obesity were admitted for COVID-19 between January 1 and May 15, 2020. Of these patients, 541 had a history of BS and 7745 did not. The need for invasive mechanical ventilation and death occurred in 7% and 3.5% of the BS group versus 15% and 14.2% of the control group, respectively. In logistic regression, the risk of invasive mechanical ventilation was independently associated with increasing age, male sex, and hypertension, and mortality was independently associated with increasing age, male sex, history of heart failure, cancer, and diabetes, whereas BS had an independent protective effect. Two random exact matching tests confirmed the protective effect of BS. CONCLUSION: This nationwide study showed that BS is independently associated with a reduced risk of death and invasive mechanical ventilation in obese individuals with COVID-19.