BackgroundThe optimal approach to operative treatment of humeral shaft fractures remains debatable. Previously published trials have been limited in size and have been inconclusive regarding important patient outcome variables following treatment with either intramedullary nails or plates. We conducted a meta-analysis of available trials comparing treatment of humeral shaft fractures.Methods We performed a literature search from 1967 to November 2007 in the main medical search engines and selected 4 randomized trials that compared nails and plates in patients with humeral shaft fractures and that reported on complications due to surgery. We statistically pooled patient data using standard meta-analytic approaches. Our primary outcome was the total complication rate, comprised of all complications listed in the articles included. Secondary outcomes included non-union, infection, nerve palsy, and reoperation rate. Methodology was assessed using the CLEAR NPT.Results When pooling the data of the 4 trials (n = 203 patients), we did not find a statistically significant difference between implants in the rate of total complications, non-union, infection, nerve-palsy, or the need for reoperation. The studies included were small and had methodological limitations.Conclusions Our meta-analysis suggests stastistically insignificant differences between plates and nails in the treatment of humeral shaft fractures. Small sample sizes, study heterogeneity, and methodological limitations argue strongly for a definitive, large trial. We recommend that this trial should be a randomized controlled trial with appropriate allocation of patients and blinding of patients and care providers and outcome assessors, and that it should include patient-important outcomes.

BackgroundIn 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/designThis 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.DiscussionResults 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 registrationThe trial is registered at the Netherlands Trial Register on July 6th, 2017 (NTR 6528).Electronic supplementary materialThe online version of this article (10.1186/s12893-018-0359-6) contains supplementary material, which is available to authorized users.

Accuracy of NSCLC staging in the Netherlands is low (54.6%), even in the era of positron emission tomography-computed tomography. Especially accurate nodal staging remains challenging. Future efforts should include the identification of specific pitfalls in NSCLC staging.

Concordance between clinical and pathologic stage is 59.9%. In patients with clinical stage I NSCLC, 22.6% were upstaged to pathologic stage II or higher, which is an indication for adjuvant chemotherapy. Improvement in accuracy of staging is thus needed, particularly for these patients.

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.