Evolution of therapeutic management of patients with ANCA associated vasculitis in France after licensing Rituximab use.

INTRODUCTION: In 2013, rituximab was approved in France for the treatment of ANCA-associated vasculitis (AAV). The aim of the study was to compare the treatment and health events of adult incident patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), included before rituximab approval (over 2010-2012, Group 1) and those included after rituximab approval (over 2014-2017, Group 2). METHOD: Data were extracted from the French National Health Insurance database (SNDS) including outpatient health care consumption and hospital discharge forms. Comparisons between inclusion periods were performed using Wilcoxon and χ² tests. Kaplan-Meier method was used to model the duration of treatment induction, maintenance, and off-drug periods. Fine and Gray tests were used to compare treatment phase durations. RESULTS: A total of 694 GPA and 283 MPA patients were included in Group 1, while 668 GPA and 463 MPA patients were included in Group 2. Between the two inclusion periods, the proportions of patients treated with rituximab increased in the induction and maintenance phases whereas treatment with azathioprine declined. These proportions remained stable in the case of methotrexate, cyclophosphamide, and glucocorticoid-treated patients. Frequency of first-time hospitalized infections, diabetes and renal failure during the first year after inclusion increased for both groups. LIMITATIONS OF THE STUDY: This is a retrospective study based on claims data including only 76% of people covered by health insurance in France. The period studied includes the learning phase of using rituximab. This study lacks biological data and precise quantitative analysis for the use of steroids, therefore the criteria for establishing diagnosis and therapeutic choice were unknown. CONCLUSIONS: Introduction of rituximab reduced the use of azathioprine without affecting the use of glucocorticoids or cyclophosphamide.

Editor's Choice -- Survival, Limb Salvage, and Management of Patients with Lower Limb Acute Ischaemia: A French National Retrospective Observational Study.

OBJECTIVE: The aim was to describe the baseline characteristics of French patients referred with acute limb ischaemia (ALI), and their clinical management and outcome (death, amputation). METHODS: This retrospective observational cohort study used the National Health Data System. All adults hospitalised for ALI who underwent revascularisation with an endovascular or open surgical approach between 1 January 2015 and 31 December 2020 were included and followed up until death or the end of the study (31 December 2021). A one year look back period was used to capture patients' medical history. The risks of death, and major and minor amputations were described using Kaplan-Meier and Aalen-Johansen estimators. A Cox model was used to report the adjusted association between groups and risk of death and Fine-Gray models for the risk of amputations considering the competing risk of death. RESULTS: Overall, 51 390 patients (median age 70 years, 69% male) were included and had a median follow up of 2.7 years: 39 411 (76.7%) were treated with an open approach and 11 979 (23.3%) with a percutaneous endovascular approach. The preferred approach for the revascularisation varied between French regions. The one year overall survival was 78.0% and 85.2% in the surgery and endovascular groups, respectively. The surgery group had a higher risk of death (hazard ratio [HR] 1.17, 95% CI 1.12 - 1.21), a higher risk of major amputation (sub-distribution HR 1.20, 95% CI 1.10 - 1.30) and lower risk of minor amputation (sub-distribution HR 0.66, 95% CI 0.60 - 0.71) than the endovascular group. Diabetes and dialysis increased the risk of major amputation by 52% and 78%, respectively. Subsequent ALI was the third most common cause of hospital re-admission within one year. CONCLUSION: ALI remains a condition at high risk of death and amputation. Individual risk factors and ALI severity need to be considered to choose between approaches. Continued prevention efforts, improved management, and access to the most suitable approach are necessary.

Incidence, prevalence, and treatment of anemia of non-dialysis-dependent chronic kidney disease: A retrospective database study in France.

BACKGROUND: Minimal data are available regarding the prevalence and incidence of anemia among patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) in France. METHODS: This was a retrospective non-interventional study of patients with a record of NDD-CKD in the Echantillon Généraliste des Bénéficiaires (EGB) database between January 01, 2012, and December 31, 2017. The primary objective was to estimate the annual incidence and prevalence of anemia of NDD-CKD. Secondary objectives included description of the demographics and clinical characteristics of patients with NDD-CKD-related anemia. An exploratory objective was to use machine learning to identify patients from the general population that might have NDD-CKD but without a recorded ICD-10 diagnosis of CKD. RESULTS: During 2012-2017, 9865 adult patients in the EGB database had confirmed NDD-CKD; of these, 49.1% (4848/9865) had anemia. From 2015 to 2017, estimates of incidence (108.7-114.7 per 1000 population) and prevalence (435.7-449.5 per 1000 population) of NDD-CKD-related anemia were stable. Less than half of patients with anemia of NDD-CKD were treated with oral iron, and approximately 15% were treated with erythropoiesis-stimulating agents. Based on adult French population projections in 2020 and an estimated prevalence rate in 2017 of 42.2 per 1000 population for confirmed plus possible NDD-CKD (as a proportion of the general French population), the estimated number of patients with possible NDD-CKD in France was 2,256,274, approximately five-fold greater than the number identified by diagnostic codes and hospitalizations. CONCLUSIONS: Anemia of NDD-CKD was shown to be a constant long-term burden in France, and its apparent prevalence may still be significantly underestimated. Given the potential treatment gap, additional initiatives to better identify and treat NDD-CKD anemia may improve patient management and treatment outcomes.

Therapeutic management and outcome of patients with advanced systemic mastocytosis treated with midostaurin: A comprehensive real-life study in the French national healthcare database.

Advanced Systemic Mastocytosis (Adv-SM) is rare and has a poor prognosis. Midostaurin (Rydapt® ) is one of the few treatments for Adv-SM in Europe. The study aims were to describe the characteristics of patients treated with midostaurin, their treatment modalities, outcomes, and serious events requiring hospitalization. This retrospective observational study was conducted using the French National Healthcare Database (SNDS) and included adult Adv-SM patients treated with midostaurin between 01-01-2012 and 09-30-2018. Kaplan-Meier method was used to assess survival and treatment duration. Eighty-one patients were included: 37 with Aggressive Systemic Mastocytosis (SM) (46%), 31 with SM with an Associated Hematological Neoplasm (38%), and 4 with Mast Cell Leukemia (5%). The SM subtype was undetermined in 9 patients (11%). The median age was 67 years; 64% of patients were male. Over the mean follow-up of 11.4 months, median midostaurin treatment duration was 8.4 months and 28 patients (35%) were still under treatment at the end of the study. One-year and 5-year overall survival rates estimated since the time of diagnosis were 83% and 56%, respectively. Twelve serious events (among those frequently reported during clinical trials and compassionate use) requiring hospitalization were identified; a causal association with Adv-SM treatment could neither be excluded nor established. In this first real-life study on patients treated with midostaurin for Adv-SM, the patients' characteristics, their management, treatment discontinuation, and survival were in line with previous results (compassionate use and clinical trials).

Impact of Gastric Electrical Stimulation on Economic Burden of Refractory Vomiting: A French Nationwide Multicentre Study.

BACKGROUND & AIMS: Medico-economic data of patients suffering from chronic nausea and vomiting are lacking. In these patients, gastric electrical stimulation (GES) is an effective, but costly treatment. The aim of this study was to assess the efficacy, safety and medico-economic impact of Enterra therapy in patients with chronic medically refractory nausea and vomiting. METHODS: Data were collected prospectively from patients with medically refractory nausea and/or vomiting, implanted with an Enterra device and followed for two years. Gastrointestinal quality of life index (GIQLI) score, vomiting frequency, nutritional status and safety were evaluated. Direct and indirect expenditure data were prospectively collected in diaries. RESULTS: Complete clinical data were available for142 patients (60 diabetic, 82 non-diabetic) and medico-economic data were available for 96 patients (36 diabetic, 60 non-diabetic), 24 months after implantation. GIQLI score increased by 12.1 ± 25.0 points (p < .001), with a more significant improvement in non-diabetic than in diabetic patients (+15.8 ± 25.0 points, p < .001 versus 7.3 ± 24.5 points, p = .027, respectively). The proportion of patients vomiting less than once per month increased by 25.5% (p < .001). Hospitalisations, time off work and transport were the main sources of costs. Enterra therapy decreased mean overall healthcare costs from 8873 US$ to 5525 US$ /patient/year (p = .001), representing a saving of 3348 US$ per patient and per year. Savings were greater for diabetic patients (4096 US$ /patient/year) than for non-diabetic patients (2900 US$ /patient/year). CONCLUSIONS: Enterra therapy is an effective, safe and cost-effective option for patients with refractory nausea and vomiting. CLINICALTRIALS: gov Identifier: NCT00903799.

Public health impact and cost-effectiveness of a nine-valent gender-neutral HPV vaccination program in France.

OBJECTIVES: In France, 9-valent HPV vaccination is recommended routinely for 11-14-years-old girls and as catch-up for 15-19-years-old girls. Recently, recommendation for gender-neutral vaccination (GNV) has been approved. The objectives of the study were to assess the public health impact and cost-effectiveness of a 9-valent GNV compared with girls-only vaccination program (GOV). METHODS: A published HPV disease transmission dynamic model accounting for herd protection effects with a 100-year time horizon was adapted and calibrated to French data. Epidemiological and economic outcomes included disease cases averted and quality-adjusted life years (QALY). Costs and incremental cost-effectiveness ratio (ICER) were measured in 2018 Euros (€). A coverage rate of 26.2% among girls and boys was assumed for the GNV program based on the current female coverage rate in France. The base case included genital warts, cervical, vulvar, vaginal, and anal cancers. Scenario analyses included all HPV-related diseases and considered higher vaccination coverage rate (60%). Deterministic sensitivity analyses on key inputs were performed. RESULTS: Over 100 years, GNV resulted in an additional reduction of 9,519 and 3,037 cervical cancer cases and deaths; 6,901 and 1,166 additional anal cancer cases and deaths; and a reduction of additional 1,284,077 genital warts compared with current GOV and an ICER of 24,763€/QALY. When including all HPV-related diseases, the ICER was 15,184€/QALY. At a higher coverage rate (60%), GNV would prevent 17,430 and 4,334 additional anogenital cancer cases and deaths and over two million genital warts compared with GOV with an ICER of 40,401€/QALY. Results were sensitive to a higher discount rate (6% versus 4%) and a shorter duration of protection (20 years versus lifetime). CONCLUSIONS: In France, GNV has a significant impact in terms of public health benefits and may be considered cost-effective compared with GOV at low and high coverage rates.

Assessing the epidemiological impact on cervical cancer of switching from 4-valent to 9-valent HPV vaccine within a gender-neutral vaccination programme in Switzerland.

BACKGROUND: An infection with high-risk human papillomavirus (HPV) is the obligatory aetiological factor for the development of cervical cancer. In Switzerland, the prevention strategy for cervical cancer is based on primary prevention via HPV vaccination and secondary prevention with an opportunistic screening programme for precancerous lesions. Vaccination is recommended to 11-26 years old male and female persons. The objective of the study was to assess the epidemiological impact on cervical cancer of switching from the currently implemented programme with the 4-valent vaccine to the 9-valent vaccine, in an 11-26 years old gender-neutral vaccination programme in Switzerland. METHODS: A previously validated dynamic transmission model of HPV infections was adapted and calibrated to the Swiss setting assuming an 80% coverage rate in HPV-vaccination and lifelong vaccine type-specific protection. A gender-neutral vaccination programme (males and females) for 11-26 years old with a 9-valent HPV vaccine was compared with the current 11-26 years old gender-neutral 4-valent vaccination programme. Sensitivity analyses were conducted in order to test the impact of lower vaccination coverage rates and a shorter duration of protection on the model outcomes. RESULTS: In Switzerland, a 9-valent gender-neutral vaccination programme would result in an additional prevention of 2979 cervical cancer cases, 13,862 CIN3 and 15,000 CIN2 cases, compared with the 4-valent gender-neutral vaccination programme over 100 years. These additional disease cases avoided would correspond to a 24, 36 and 48% cumulative incidence decrease in cervical cancer, CIN3 and CIN2 cases, respectively. It would also prevent additional 741 cervical cancer-related deaths over 100 years. A substantial additional reduction in cervical cancer and precancerous lesions burden is still observed when varying the vaccination coverage rate from 30 to 60% or reducing the duration of protection from lifelong to 20 years. CONCLUSIONS: The switch to the 9-valent vaccine in Switzerland to prevent cervical diseases showed an important contribution in terms of public health impact compared with the 4-valent vaccine in an 11-26 years old gender-neutral population, even with very conservative assumptions such as low coverage rates or low duration of protection and limiting analysis to only cervical disease.

Gastric Electrical Stimulation Reduces Refractory Vomiting in a Randomized Crossover Trial.

BACKGROUND & AIMS: There have been conflicting results from trials of gastric electrical stimulation (GES) for treatment of refractory vomiting, associated or not with gastroparesis. We performed a large, multicenter, randomized, double-blind trial with crossover to study the efficacy of GES in patients with refractory vomiting, with or without gastroparesis. METHODS: For 4 months, we assessed symptoms in 172 patients (66% women; mean age ± standard deviation, 45 ± 12 years; 133 with gastroparesis) with chronic (>12 months) of refractory vomiting (idiopathic, associated with a type 1 or 2 diabetes, or postsurgical). A GES device was implanted and left unactivated until patients were randomly assigned, in a double-blind manner, to groups that received 4 months of stimulation parameters (14 Hz, 5 mA, pulses of 330 µs) or no stimulation (control); 149 patients then crossed over to the other group for 4 months. Patients were examined at the end of each 4-month period (at 5 and 9 months after implantation). Primary endpoints were vomiting score, ranging from 0 (daily vomiting) to 4 (no vomiting), and the quality of life, assessed by the Gastrointestinal Quality of Life Index scoring system. Secondary endpoints were changes in other digestive symptoms, nutritional status, gastric emptying, and control of diabetes. RESULTS: During both phases of the crossover study, vomiting scores were higher in the group with the device on (median score, 2) than the control group (median score, 1; P < .001), in diabetic and nondiabetic patients. Vomiting scores increased significantly when the device was ON in patients with delayed (P < .01) or normal gastric emptying (P = .05). Gastric emptying was not accelerated during the ON period compared with the OFF period. Having the GES turned on was not associated with increased quality of life. CONCLUSIONS: In a randomized crossover study, we found that GES reduced the frequency of refractory vomiting in patients with and without diabetes, although it did not accelerate gastric emptying or increase of quality of life. Clinicaltrials.gov, Number: NCT00903799.

Renal Replacement Therapy Modality in the ICU and Renal Recovery at Hospital Discharge.

OBJECTIVES: Acute kidney injury requiring renal replacement therapy is a major concern in ICUs. Initial renal replacement therapy modality, continuous renal replacement therapy or intermittent hemodialysis, may impact renal recovery. The aim of this study was to assess the influence of initial renal replacement therapy modality on renal recovery at hospital discharge. DESIGN: Retrospective cohort study of all ICU stays from January 1, 2010, to December 31, 2013, with a "renal replacement therapy for acute kidney injury" code using the French hospital discharge database. SETTING: Two hundred ninety-one ICUs in France. PATIENTS: A total of 1,031,120 stays: 58,635 with renal replacement therapy for acute kidney injury and 25,750 included in the main analysis. INTERVENTIONS: None. MEASUREMENTS MAIN RESULTS: PPatients alive at hospital discharge were grouped according to initial modality (continuous renal replacement therapy or intermittent hemodialysis) and included in the main analysis to identify predictors of renal recovery. Renal recovery was defined as greater than 3 days without renal replacement therapy before hospital discharge. The main analysis was a hierarchical logistic regression analysis including patient demographics, comorbidities, and severity variables, as well as center characteristics. Three sensitivity analyses were performed. Overall mortality was 56.1%, and overall renal recovery was 86.2%. Intermittent hemodialysis was associated with a lower likelihood of recovery at hospital discharge; odds ratio, 0.910 (95% CI, 0.834-0.992) p value equals to 0.0327. Results were consistent across all sensitivity analyses with odds/hazards ratios ranging from 0.883 to 0.958. CONCLUSIONS: In this large retrospective study, intermittent hemodialysis as an initial modality was associated with lower renal recovery at hospital discharge among patients with acute kidney injury, although the difference seems somewhat clinically limited.

Burden of Idiopathic Pulmonary Fibrosis Progression: A 5-Year Longitudinal Follow-Up Study.

Idiopathic pulmonary fibrosis (IPF) is a fatal lung disease with an unpredictable course. An observational study was set up using the French hospital discharge database to describe the reasons, outcomes and costs of hospitalisations related to this disease. Patients newly hospitalised for idiopathic pulmonary fibrosis (ICD-10 code: J84.1) in 2008 were identified and followed for 5 years. As J84.1 includes other fibrotic pulmonary diseases, an algorithm excluding age<50 years and presence of a differential diagnosis in the following year was defined. Overall, 6,476 patients were identified; of whom 30% were admitted through the emergency unit and 12% died during their first hospitalisation. Most of patients were hospitalised at least once for one or several acute events (n = 5,635; 87.0% of patients), of whom 36.5% of patients with an acute respiratory worsening (in-hospital mortality of 17.0% and median cost of €3,224; interquartile range (IQR €889-6,092)), 43.7% of patients with a respiratory infection (in-hospital mortality of 29.5% and median cost of €5,432 (IQR, €3,620-9,115)) and 51.7% of patients with a cardiac event (in-hospital mortality of 35.7% and median cost of €4,584 (IQR, €2,803-6,399)); 30.2% of these events occurred during the first hospitalisation. Finally, the 3-year in-hospital mortality crude rate was 36.8%. This study is the first providing extensive data on hospitalisations in patients with pulmonary fibrosis, mostly idiopathic, in France, demonstrating high burden and hospital cost.

Outcomes, risk factors and health burden of contrast-induced acute kidney injury: an observational study of one million hospitalizations with image-guided cardiovascular procedures.

BACKGROUND: Despite the use of low-osmolar contrast media that have significantly reduced the occurrence of severe adverse reactions, contrast-induced (CI) acute kidney injury (AKI) remains the third cause of AKI in hospitals. We sought to estimate the frequency of CI-AKI among hospitalized patients undergoing image-guided cardiovascular procedures, to quantify the effect of risk factors on the development of this complication and to assess relative organizational and economic burden in healthcare. METHODS: A retrospective cross-sectional population-based study using the extensive French hospital discharge database (PMSI) was carried out. Hospitalizations with image-guided cardiovascular procedures using a contrast media were identified in adults over a 2-year period (2012-2013). Suspected CI-AKI was defined as the presence, during hospitalization, of a diagnostic code of AKI (International Classification of Diseases, 10th revision [ICD-10] codes: N141, 142, N144, N990, N17, N19 or R392) or a code of renal replacement therapy procedure (Classification Commune des Actes Médicaux [CCAM] codes: JVJB001, JVJF002-005 and JVJF008) as creatinine criteria were not available. RESULTS: During 1,047,329 hospitalizations studied, 32,308 suspected CI-AKI were observed, yielding a frequency of 3.1 %. By multivariate analysis, factors that significantly increased the risk of suspected CI-AKI included cardiogenic shock (odds ratio [OR] = 20.5, 95 % confidence interval [95 % CI] [18.7; 22.5]), acute heart failure (OR = 2.5, 95 % CI [2.4; 2.6]) and chronic kidney disease (OR = 2.3, 95 % CI [2.2; 2.3]. Renal replacement therapy was initiated during 6,335 (0.6 %) hospitalizations. The mean length of stay and cost of hospitalizations associated with suspected CI-AKI was higher than in hospitalizations without suspected CI-AKI (20.5 vs 4.7 days, p < 0.00001 and €15,765 vs €3,352, p < 0.0001, respectively). CONCLUSIONS: This is the first large-scale population-based study to estimate frequency and health burden of suspected CI-AKI occurring after image-guided cardiovascular procedures, and the first available data in a French population. We showed that this iatrogenic complication remains of high concern despite prevention efforts and contrast media product improvement. From our results, suspected CI-AKI is associated with particularly high mortality, significantly extends hospitalizations, and leads to additional costs reaching a total of €200M per year.

Hospital Cost of Staphylococcal Infection after Cardiothoracic or Orthopedic Operations in France: A Retrospective Database Analysis.

BACKGROUND: Staphylococcal infections (SI) after cardiothoracic (CT) or orthopedic (OP) surgery are associated with extended length of stay (LOS), a considerable mortality rate, and high cost. No data on these consequences have been published in France. Therefore, a study was conducted to describe the epidemiologic, clinical, and economic outcomes of SI following these operations in France based on a hospital discharge database. METHODS: Patients who underwent the most common types of CT or OP operations in 2009 were identified and followed for one year. Staphylococcal infections occurring in the three following months were identified. RESULTS: In 2009, 21,543 patients underwent one of the selected CT procedures (62% coronary artery bypass grafting; 38% cardiac valve replacement) and 175,518 patients underwent one of the selected OP procedures (64% hip arthroplasty; 36% knee arthroplasty). Among the patients, 4.4% (n=955) and 0.9% (n=1,515) developed SI after CT and OP surgery, respectively. Staphylococcal infection led to approximately 1.0 and 1.4 additional hospitalizations per patient, 22.1 and 24.1 additional hospital days, and an excess cost of €15,475 and €13,389 after an CT or OP procedure, respectively. The in-hospital mortality rate was 2.6 times and 6 times greater in infected patients than in non-infected patients for CT and OP. Hospital cost reached €505 million for these two CT procedures and €1.9 billion for the two OP procedures, of which €15 million and €20 million were related directly to patients having developed SI. CONCLUSIONS: Staphylococcal infections after common CT or OP operations were associated with greater mortality rates and hospital costs secondary to the additional procedures and greater LOS.

Acute Ischemic Stroke (AIS) patient management in French stroke units and impact estimation of thrombolysis on care pathways and associated costs.

BACKGROUND: Stroke is the second leading cause of death and a first leading cause of acquired disability in adults worldwide. This study aims to evaluate the current management and associated costs of acute ischemic stroke (AIS) for patients admitted in stroke units in France and over a one-year follow-up period as well as to assess the impact of improved thrombolytic management in terms of increasing the proportion of patients receiving thrombolysis and/or treated within 3 h from the onset of symptoms. METHODS: A decision model was developed, which comprises two components: the first corresponding to the acute hospital management phase of patients with AIS up until hospital discharge, extracted from the national hospital discharge database (PMSI 2011), and the second corresponding to the post-acute (post-discharge) phase, based on national treatment guidelines and stroke experts' advice. Five post-acute clinical care pathways were defined. In-hospital mortality and mortality at 3 months post-discharge was taken into account into the model. Patient journeys and costs were determined for both phases. Improved thrombolytic management was modeled by increasing the proportion of patients receiving thrombolysis from the current estimated level of 16.7 to 25% as well as subsequently increasing the proportion of patients treated within 3 h of the onset of symptoms post-stroke from 50 to 100%. The impact on care pathways was derived from clinical data. RESULTS: Among 202,078 hospitalizations for a stroke or a transient ischemic attack (TIA), 90,528 were for confirmed AIS, and 33% (29,999) of them managed within a stroke unit. After hospitalization, 60% of discharges were to home, 25% to rehabilitative care and then home, 2% to rehabilitative care and then a nursing home, 7% to long-term care, and 6% of stays ended with patient death. Of a total cost over 1 year of €610 million (mean cost per patient of €20,326), 70% concern the post-acute phase. By increasing the proportion of patients being thrombolyzed, costs are reduced primarily by a decrease in rehabilitative care, with savings per additional treated patient of €1,462. By adding improved timing, savings are more than doubled (€3,183 per additional treated patient). CONCLUSIONS: This study confirms that the burden of AIS in France is heavy. By improving thrombolytic management in stroke units, patient journeys through care pathways can be modified, with increased discharges home, a change in post-acute resource consumption and net savings.

Characterization and prediction of prolonged air leak after pulmonary resection: a nationwide study setting up the index of prolonged air leak.

BACKGROUND: The objective of this study was to better characterize prolonged air leak (PAL), defined as an air leak longer than 7 days, and to develop and validate a predictive model of this complication after pulmonary resection. METHODS: All lung resections entered in Epithor, the French national thoracic database (French Society of Thoracic and Cardiovascular Surgery), were analyzed. Data collected between 2004 and 2008 (n=24,113) were used to build the model using backward stepwise variable selection, and the 2009 data (n=6,813) were used for external validation. The primary outcome was PAL. Results of the predictive model were used to propose a score: the index of PAL (IPAL). RESULTS: Prevalence of PAL after pulmonary resection was 6.9% (n=1,655) in the development data set. In the final model, 9 variables were selected: gender, body mass index, dyspnea score, presence of pleural adhesions, lobectomy or segmentectomy, bilobectomy, bulla resection, pulmonary volume reduction, and location on upper lobe. In the development data set, the C-index was 0.71 (95% confidence interval [CI], 0.70 to 0.72). At external validation, the C-index was 0.69 (95% CI, 0.66 to 0.72) and the calibration slope (ie, the agreement between observed outcomes and predictions) was 0.874 (<1). A score chart based on these analyses has been proposed. The formula to calculate the IPAL is the following: gender (F=0; M=4)-(body mass index-24)+2×dyspnea score+pleural adhesion (no=0; yes=4)+pulmonary resection (wedge=0; lobectomy or segmentectomy=7; bilobectomy=11; bulla resection=2; volume reduction=14)+location (lower or middle lobe=0; upper=4). CONCLUSIONS: Surgeons can easily use the well-validated model to determine intraoperative preventive measures of PAL.