Pneumonectomy for Lung Cancer Treatment in The Netherlands: Between-Hospital Variation and Outcomes.

BACKGROUND: Pneumonectomy in lung cancer treatment is associated with considerable morbidity and mortality. Its use is reserved only for patients in whom a complete oncological resection by (sleeve) lobectomy is not possible. It is unclear whether a patients' risk of receiving a pneumonectomy is equally distributed. This study examined between-hospital variation of pneumonectomy use for primary lung cancer in the Netherlands. METHODS: Data from the Dutch Lung Cancer Audit for Surgery from 2012 to 2016 were used to study the use of pneumonectomy for primary lung cancer in the Netherlands. Using multivariable logistic regression, factors associated with pneumonectomy use were identified and the expected number of pneumonectomies per hospital was determined. Subsequently, the observed/expected ratio (O/E ratio) per hospital was calculated to study between-hospital differences. RESULTS: Of the 8446 included patients, 659 (7.8%) underwent a pneumonectomy with a mean postoperative mortality of 7.1% (n = 47). Factors associated with receiving a pneumonectomy were age, gender, cardiac and pulmonary comorbidities, tumor side, size and histopathology. The pneumonectomy use in the Netherlands varied considerably between hospitals (IQR 5.5-10.1%). Three hospitals out of 51 performed significantly less pneumonectomies than expected (O/E ratio < 0.5) and three significantly more (O/E ratio > 1.7). In the latter group, severe complications were more frequent, taking other influencing factors into account (OR 1.51, 95% CI 1.05-2.19). CONCLUSIONS: There is a considerable between-hospital variation in pneumonectomy use in lung cancer treatment. To further optimize surgical lung cancer care, we suggest center-specific feedback on pneumonectomy use and the development of a risk-adjusted pneumonectomy indicator.

MEDIASTinal staging of non-small cell lung cancer by endobronchial and endoscopic ultrasonography with or without additional surgical mediastinoscopy (MEDIASTrial): study protocol of a multicenter randomised controlled trial.

BACKGROUND: In case of suspicious lymph nodes on computed tomography (CT) or fluorodeoxyglucose positron emission tomography (FDG-PET), advanced tumour size or central tumour location in patients with suspected non-small cell lung cancer (NSCLC), Dutch and European guidelines recommend mediastinal staging by endosonography (endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS)) with sampling of mediastinal lymph nodes. If biopsy results from endosonography turn out negative, additional surgical staging of the mediastinum by mediastinoscopy is advised to prevent unnecessary lung resection due to false negative endosonography findings. We hypothesize that omitting mediastinoscopy after negative endosonography in mediastinal staging of NSCLC does not result in an unacceptable percentage of unforeseen N2 disease at surgical resection. In addition, omitting mediastinoscopy comprises no extra waiting time until definite surgery, omits one extra general anaesthesia and hospital admission, and may be associated with lower morbidity and comparable survival. Therefore, this strategy may reduce health care costs and increase quality of life. The aim of this study is to compare the cost-effectiveness and cost-utility of mediastinal staging strategies including and excluding mediastinoscopy. METHODS/DESIGN: This study is a multicenter parallel randomized non-inferiority trial comparing two diagnostic strategies (with or without mediastinoscopy) for mediastinal staging in 360 patients with suspected resectable NSCLC. Patients are eligible for inclusion when they underwent systematic endosonography to evaluate mediastinal lymph nodes including tissue sampling with negative endosonography results. Patients will not be eligible for inclusion when PET/CT demonstrates 'bulky N2-N3' disease or the combination of a highly suspicious as well as irresectable mediastinal lymph node. Primary outcome measure for non-inferiority is the proportion of patients with unforeseen N2 disease at surgery. Secondary outcome measures are hospitalization, morbidity, overall 2-year survival, quality of life, cost-effectiveness and cost-utility. Patients will be followed up 2 years after start of treatment. DISCUSSION: Results of the MEDIASTrial will have immediate impact on national and international guidelines, which are accessible to public, possibly reducing mediastinoscopy as a commonly performed invasive procedure for NSCLC staging and diminishing variation in clinical practice. TRIAL REGISTRATION: The trial is registered at the Netherlands Trial Register on July 6th, 2017 ( NTR 6528 ).

Textbook outcome as a composite outcome measure in non-small-cell lung cancer surgery.

OBJECTIVES: Quality assessment is an important element in providing surgical cancer care. The main objective of this study was to develop a new composite measure 'textbook outcome', to evaluate and improve quality of surgical care for patients undergoing a resection for non-small-cell lung cancer (NSCLC). METHODS: All patients undergoing an anatomical resection for NSCLC from 2012 to 2016 registered in the nationwide Dutch Lung Cancer Audit were included in an analysis to assess usefulness of a composite measure as a quality indicator. Based on expert opinion, textbook outcome was defined as having a complete resection (negative resection margins and sufficient lymph node dissection), plus no 30-day or in-hospital mortality, no reintervention in 30 days, no readmission to the intensive care unit, no prolonged hospital stay (<14 days), no hospital readmission after discharge and no major complications. The percentage of patients with a textbook outcome was calculated per hospital. Between-hospital variation in textbook outcome was analysed using case-mix adjustment models. RESULTS: In total, 5513 patients were included in this study. Textbook outcome was achieved in 26.4% of patients. Insufficient lymph node dissection had the most substantial effect on not realizing textbook outcome. If 'sufficient lymph node dissection' was not included as a criterion, textbook outcome would be 60.7%. Case-mix adjusted textbook outcome proportions per hospitals varied between 13.2% and 37.7%. CONCLUSIONS: In contrast to focusing on a single aspect, the composite measure textbook outcome provides insight into comprehensive performance in NSCLC surgery. It can be used to evaluate both individual hospitals and national performance and provides the opportunity to give benchmarked feedback to thoracic surgeons.

Surgical treatment of pulmonary metastases in the Netherlands: data from the Dutch Lung Cancer Audit for Surgery.

OBJECTIVES: Surgical resection is widely employed as a potential curative treatment option for patients with limited lung metastases originating from a wide range of primary tumours. However, there are no clear national or international practice guidelines and, thereby, the risk for potential practice variation exists. This study aims to define the current practice for the surgical treatment of pulmonary metastases in the Netherlands by using data from the Dutch Lung Cancer Audit for Surgery (DLCA-S). METHODS: Data from the DLCA-S were used to analyse patients undergoing a parenchymal lung resection for the treatment of pulmonary metastases between 2012 and 2017. Volume of metastasectomies per hospital was calculated as a proportion of the volume of primary lung cancer resection. Studied outcomes were overall complications and postoperative mortality and complicated course. For the latter, both the national average and between-hospital variation were calculated. RESULTS: A total of 2090 patients, distributed over 45 Dutch hospitals, were included for analysis. The most common primary cancer was colorectal carcinoma (N = 1087, 52.0%) followed by the urogenital carcinoma (N = 296, 14.2%). The most common type of parenchymal resection was a wedge resection (N = 1477, 70.7%) followed by a lobectomy (N = 424, 20.3%). Resection was performed minimally invasively in 1548 patients (74.1%) with a conversion rate of 3.8%. Resection of a solitary metastasis was performed in 1663 patients (79.6%). In 40 patients (1.9%), 4 or more metastases were resected. A postoperative complicated course was noted in 3.6%, and the 30-day mortality rate was 0.7%. The variety between hospitals in the volume of metastasectomies in proportion to the volume of primary lung cancer resections was 3.4-41.5%. CONCLUSIONS: This analysis of the DLCA-S registry provides a unique insight into current practice on pulmonary metastasectomies in the Netherlands over a 6-year period. The rate of postoperative adverse outcome was limited, and the morbidity and mortality were lower compared to primary lung cancer resections in the DLCA-S database.

Variation Between Multidisciplinary Tumor Boards in Clinical Staging and Treatment Recommendations for Patients With Locally Advanced Non-small Cell Lung Cancer.

BACKGROUND: Accurate diagnosis and staging are crucial to ensure uniform allocation to the optimal treatment methods for non-small cell lung cancer (NSCLC) patients, but may differ among multidisciplinary tumor boards (MDTs). Discordance between clinical and pathologic TNM stage is particularly important for patients with locally advanced NSCLC (stage IIIA) because it may influence their chance of allocation to curative-intent treatment. We therefore aimed to study agreement on staging and treatment to gain insight into MDT decision-making. RESEARCH QUESTION: What is the level of agreement on clinical staging and treatment recommendations among MDTs in stage IIIA NSCLC patients? STUDY DESIGN AND METHODS: Eleven MDTs each evaluated the same 10 pathologic stage IIIA NSCLC patients in their weekly meeting (n = 110). Patients were selected purposively for their challenging nature. All MDTs received exactly the same clinical information and images per patient. We tested agreement in cT stage, cN stage, cM stage (TNM 8th edition), and treatment proposal among MDTs using Randolph's free-marginal multirater kappa. RESULTS: Considerable variation among the MDTs was seen in T staging (κ, 0.55 [95% CI, 0.34-0.75]), N staging (κ, 0.59 [95% CI, 0.35-0.83]), overall TNM staging (κ, 0.53 [95% CI, 0.35-0.72]), and treatment recommendations (κ, 0.44 [95% CI, 0.32-0.56]). Most variation in T stage was seen in patients with suspicion of invasion of surrounding structures, which influenced such treatment recommendations as induction therapy and type. For N stage, distinction between N1 and N2 disease was an important source of discordance among MDTs. Variation occurred between 2 patients even regarding M stage. A wide range of additional diagnostics was proposed by the MDTs. INTERPRETATION: This study demonstrated high variation in staging and treatment of patients with stage IIIA NSCLC among MDTs in different hospitals. Although some variation may be unavoidable in these challenging patients, we should strive for more uniformity.

Mediastinoscopy for Staging of Non-Small Cell Lung Cancer: Surgical Performance in The Netherlands.

BACKGROUND: Accurate staging of the mediastinal lymph nodes is of great importance to determine optimal treatment options in non-small cell lung cancer (NSCLC). In case of suspected mediastinal metastases, endoscopic/endobronchial ultrasound combined with mediastinoscopy is the gold standard. The diagnostic value of these procedures stands or falls by how they are technically performed. This study used data from the Dutch Lung Cancer Audit for Surgery to evaluate surgical performance of mediastinoscopies in The Netherlands. METHODS: The study included all patients with a mediastinoscopy for staging of NSCLC and subsequent resection from 2012 to 2016. Complete case analysis was performed, excluding patients with missing data on biopsies or tumor side. Location and number of biopsied stations and adherence to guidelines for performing mediastinoscopy were analyzed. The proportion of unforeseen mediastinal lymph node metastases (unforeseen N2) was compared between mediastinoscopies that did or did not comply with the Dutch guideline. RESULTS: The analysis included 1,729 patients. Mediastinoscopies were performed according to the Dutch guideline (requirements: biopsies of 2 ipsilateral stations, 1 contralateral station, and N7) in 51.4% (n = 888) and according to the European Society of Thoracic Surgeons guideline (N4 left, N4 right, and N7) in 75.4% (n = 1,303). Overall, unforeseen N2 was present in 10.2% (n = 140). In mediastinoscopies performed according to the Dutch guideline, unforeseen N2 occurred less often (8.6%) than in the nonadherence group (11.9%; p = 0.043). CONCLUSIONS: There is improvement potential in surgical performance of mediastinoscopy in The Netherlands, which is reflected by the percentage of guideline adherence and the occurrence of unforeseen N2.

National quality registries: how to improve the quality of data?

BACKGROUND: Data of quality registries are increasingly used by healthcare providers, patients, health insurance companies, and governments for monitoring quality of care, hospital benchmarking and outcome research. To provide all stakeholders with reliable information and outcomes, reliable data are of the utmost importance. METHODS: This article describes methods for quality assurance of data-used by the Dutch Institute for Clinical Auditing (DICA)-regarding: the design of a registry, data collection, data analysis, and external data verification. For the Dutch Lung Cancer Audit for Surgery (DLCA-S) results of data analysis and data verification were assessed with descriptive statistics. RESULTS: Of all registered patients in the DLCA-S in 2016 (n=2,391), 98.2% was analysable and completeness of data for calculations of transparent outcomes was 90.7%. Data verification for the year 2014 showed a case ascertainment of 99.4%. Of 15 selected hospitals, 14 were verified. All these hospitals received the conclusion 'sufficient quality' on case ascertainment, mortality (0% under-registration) and complicated course (3.3% wrongly registered complications). One hospital was not able to deliver patients lists, and therefore not verified. CONCLUSIONS: Quality of data can be promoted in many different ways. A completeness indicator and data verification are useful tools to improve data quality. Both methods were used to demonstrate the reliability of registered data in the DLCA-S. Opportunities for further improvement are standardised reporting and adequate data extraction.

Lessons learned from the Dutch Institute for Clinical Auditing: the Dutch model for quality assurance in lung cancer treatment.

BACKGROUND: Quality registries play an important role in the professional quality system for cancer treatment in The Netherlands. This article provides insight into the Dutch Lung Cancer Audit (DLCA); its core principles, initiation and development, first results and what lessons can be learned from the Dutch experience. METHODS: Cornerstones of the DLCA are discussed in detail, including: audit aims; the leading role for clinicians; web-based registration and feedback; data handling; multidisciplinary evaluation of quality indicators; close collaborations with all stakeholders in healthcare and transparency of results. RESULTS: In 2012 the first Dutch lung cancer specific sub-registry, focusing on surgical treatment was started. Since 2016 all major treating specialisms (lung oncologists, radiation-oncologists, general- and cardiothoracic surgeons-represented in the DLCA-L, -R and -S sub-registries respectively) have joined. Over time, the number of participating hospitals and included patients has increased. In 2016, the numbers of included patients with a non-small cell lung cancer (NSCLC) were 3,502 (DLCA-L), 2,427 (DLCA-R) and 1,979 (DLCA-S). Between sub-registries mean age varied from 66 to 70 years, occurrence of Eastern Cooperative Oncology Group (ECOG) performance score 2+ varied from 3.3% to 20.8% and occurrence of clinical stage I-II from 27.6% to 81.3%. Of all patients receiving chemoradiotherapy 64.2% was delivered concurrently. Of the surgical procedures 71.2% was started with a minimally invasive technique, with a conversion rate of 18.7%. In 2016 there were 17 publicly available quality indicators-consisting of structure, process and outcome indicators- calculated from the DLCA. CONCLUSIONS: the DLCA is a unique registry to evaluate the quality of multidisciplinary lung cancer care. It is accepted and implemented on a nationwide level, enabling participating healthcare providers to get insight in their performance, and providing other stakeholders with a transparent evaluation of this performance, all aiming for continuous healthcare improvement.

The dutch national clinical audit for lung cancer: A tool to improve clinical practice? An analysis of unforeseen ipsilateral mediastinal lymph node involvement in the Dutch Lung Surgery Audit (DLSA).

OBJECTIVE: Optimal treatment selection for patients with non-small cell lung cancer (NSCLC) depends on the clinical stage of the disease. Particularly patients with mediastinal lymph node involvement (stage IIIA-N2) should be identified since they generally do not benefit from upfront surgery. Although the standardized preoperative use of PET-CT, EUS/EBUS and/or mediastinoscopy identifies most patients with mediastinal lymph node metastasis, a proportion of these patients is only diagnosed after surgery. The objective of this study was to identify all patients with unforeseen N2 disease after surgical resection for NSCLC in a large nationwide database and to evaluate the preoperative clinical staging process. METHODS: Data was derived from the Dutch Lung Surgery Audit. Patients with pathological stage IIIA NSCLC after an anatomical resection between 2013 and 2015 were evaluated. Clinical and pathological TNM-stage were compared and an analysis was performed on the diagnostic work-up of patients with unforeseen N2 disease. RESULTS: From 3585 patients undergoing surgery for NSCLC between 2013 and 2015, a total of 527 patients with pathological stage IIIA NSCLC were included. Of all 527 patients, 254 patients were upstaged from a clinical N0 (n = 186) or N1 (n = 68) disease to a pathological N2 disease (7.1% unforeseen N2). In these 254 patients, 18 endoscopic ultrasounds, 62 endobronchial ultrasounds and 67 mediastinoscopies were performed preoperatively. CONCLUSIONS: In real world clinical practice in The Netherlands, the percentage of unforeseen N2 disease in patients undergoing surgery for NSCLC is seven percent. To further reduce this percentage, optimization of the standardized preoperative workup is necessary.

National Comparison of Hospital Performances in Lung Cancer Surgery: The Role of Case Mix Adjustment.

BACKGROUND: When comparing hospitals on outcome indicators, proper adjustment for case mix (a combination of patient and disease characteristics) is indispensable. This study examines the need for case mix adjustment in evaluating hospital outcomes for non-small cell lung cancer surgery. METHODS: Data from the Dutch Lung Cancer Audit for Surgery were used to validate factors associated with postoperative 30-day mortality and complicated course with multivariable logistic regression models. Between-hospital variation in case mix was studied by calculating medians and interquartile ranges for separate factors on the hospital level and the "expected" outcomes per hospital as a composite measure. RESULTS: A total of 8,040 patients, distributed over 51 Dutch hospitals, were included for analysis. Mean observed postoperative mortality and complicated course were 2.2% and 13.6%, respectively. Age, American Society of Anesthesiologists classification, Eastern Cooperative Oncology Group performance score, lung function, extent of resection, tumor stage, and postoperative histopathologic findings were individual significant predictors for both outcomes of postoperative mortality and complicated course. A considerable variation of these case mix factors among hospital populations was observed, with the expected mortality and complicated course per hospital ranging from 1.4% to 3.2% and from 11.5% to 17.1%, respectively. CONCLUSIONS: The between-hospital variation in case mix of patients undergoing surgical treatment for non-small cell lung cancer emphasizes the importance of proper adjustment when comparing hospitals on outcome indicators.

Dutch Lung Surgery Audit: A National Audit Comprising Lung and Thoracic Surgery Patients.

BACKGROUND: The nationwide Dutch Lung Surgery Audit (DLSA) started in 2012 to monitor and evaluate the quality of lung operations in The Netherlands as an improvement tool. This outline describes the establishment, structure, and organization of the audit by the Dutch Society of Lung Surgeons (NVvL) and the Dutch Society of Cardiothoracic Surgeons (NVT), in collaboration with the Dutch Institute for Clinical Auditing. In addition, the first 4-year results are presented. METHODS: The NVvL and NVT initiated a web-based registration, including weekly updated online feedback for participating hospitals. Data verification by external data managers is performed on regular basis. The audit is incorporated in national quality improvement programs, and participation in the DLSA is mandatory by health insurance organizations and the National Healthcare Inspectorate. RESULTS: Between January 1, 2012, and December 31, 2015, all hospitals performing lung operations participated, and a total of 19,557 patients were registered from which almost half comprised lung cancer patients. Nationwide the guideline adherence increased over the years, and 96.5% of lung cancer patients were discussed in preoperative multidisciplinary teams. Overall postoperative complications and mortality after non-small cell lung cancer operations were 15.5% and 2.0%, respectively. CONCLUSIONS: The audit provides reliable benchmarked information for caregivers and hospital management with potential to start local, regional, or national improvement initiatives. Currently, the audit is further completed with data from nonsurgical lung cancer patients, including treatment data from pulmonary oncologists and radiation oncologists. This will ultimately provide a comprehensive overview of lung cancer treatment in The Netherlands.

The spontaneous market order and evolution.

Darwin's theory of natural selection and the idea of a spontaneous order share a fundamental feature: the claim that apparent design or order do not necessarily imply a designer or rational planning. But they also present important differences, which touch upon central questions such as the evolution of morality, the role of human agency in social evolution, the existence (or not) of directionality in undesigned processes, and the presence (nor not) of a providential element in evolutionary accounts. In this article, I explore these themes and probe the relationship between the notion of a spontaneous order and the theory of evolution by natural selection. The reflections of Nobel laureate in economics, F.A. von Hayek, provide the beginning and endpoint in this voyage, for they constitute the most pronounced effort to develop a full-fledged theory combining evolution and economics in recent times. But along the way, I also investigate the influence of classical political economy on Darwin's thought, primarily that of Adam Smith, and consider the reasons for which Darwin did not refer to Smith when discussing the principle of natural selection in The Origin of Species. I conclude that the spontaneous order, as understood by Hayek, and evolution by natural selection constitute two disparate concepts.

Early knee osteoarthritis is evident one year following anterior cruciate ligament reconstruction: a magnetic resonance imaging evaluation.

OBJECTIVE: To determine the prevalence and factors associated with knee osteoarthritis (OA) defined by magnetic resonance imaging (MRI) and specific OA features on MRI 1 year after anterior cruciate ligament reconstruction (ACLR). METHODS: Isotropic 3.0T MRI scans were obtained for 111 participants (71 men; mean ± SD age 30 ± 8 years) 1 year after ACLR as well as for 20 age-, sex-, and activity level-matched uninjured controls. The MRI OA Knee Score was used to score specific OA features. MRI-defined tibiofemoral and patellofemoral OA was evaluated based on published criteria. Logistic regression identified factors associated with MRI-defined OA and specific OA features after ACLR. RESULTS: Following ACLR, medial and lateral tibiofemoral OA on MRI was observed in 7 participants (6%) and 12 participants (11%), respectively, while 19 participants (17%) had patellofemoral OA on MRI. The femoral trochlea was the region most affected by bone marrow lesions (19% of participants), cartilage lesions (31% of participants), and osteophytes (37% of participants). Meniscectomy at the time of ACLR (odds ratio 6.8 [95% confidence interval 2.0-23.3]) and body mass index (BMI) >25 kg/m(2) (odds ratio 3.0 [95% confidence interval 1.3-6.9]) predicted MRI-defined tibiofemoral OA and osteophytes, respectively. Men had higher odds of patellofemoral osteophytes (odds ratio 6.3 [95% confidence interval 2.4-16.2]). No uninjured controls had tibiofemoral or patellofemoral OA on MRI, and specific OA features were uncommon. CONCLUSION: OA 1 year following ACLR was more common than previously recognized, while being absent in uninjured control knees. The patellofemoral compartment seems to be at particular risk for early OA after ACLR, especially in men. The association with meniscectomy and BMI demonstrates the construct validity of MRI criteria.

In search of the proper scientific approach: Hayek's views on biology, methodology, and the nature of economics.

Friedrich August von Hayek (1899-1992) is mainly known for his defense of free-market economics and liberalism. His views on science--more specifically on the methodological differences between the physical sciences on the one hand, and evolutionary biology and the social sciences on the other--are less well known. Yet in order to understand, and properly evaluate Hayek's political position, we must look at the theory of scientific method that underpins it. Hayek believed that a basic misunderstanding of the discipline of economics and the complex phenomena with which it deals produced misconceptions concerning its method and goals, which led in turn to the adoption of dangerous policies. The objective of this article is to trace the development of Hayek's views on the nature of economics as a scientific discipline and to examine his conclusions concerning the scope of economic prediction. In doing so, I will first show that Hayek's interest in the natural sciences (especially biology), as well as his interest in epistemology, were central to his thought, dating back to his formative years. I will then emphasize the important place of historical analysis in Hayek's reflections on methodology and examine the reasons for his strong criticism of positivism and socialism. Finally, in the third and fourth sections that constitute the bulk of this article, I will show how Hayek's understanding of the data and goal of the social sciences (which he distinguished from those of the physical sciences), culminated in an analogy that sought to establish economics and evolutionary biology as exemplary complex sciences. I will challenge Hayek's interpretation of this analogy through a comparison with Darwin's views in The Origin of Species, and thus open a door to re-evaluating the theoretical foundations of Hayek's political claims.