Robust analyses for radiographic progression in rheumatoid arthritis.

Demonstrating inhibition of the structural damage to joints as a statistically significant difference in radiographic progression as measured by the van der Heijde modified Total Sharp Score (mTSS) is a common objective in trials for rheumatoid arthritis treatments. The frequently used analysis of the covariance model with missing data imputed using linear extrapolation (analyses of covariance, ANCOVA+LE) may not be ideal for long-term extension studies or for paediatric studies. The random coefficient (RC) model may represent a better alternative.

Secukinumab provides sustained improvement in signs and symptoms and low radiographic progression in patients with psoriatic arthritis: 2-year (end-of-study) results from the FUTURE 5 study.

Objective: Secukinumab provided sustained efficacy, low radiographic progression and consistent safety over 52 weeks in patients with psoriatic arthritis (PsA) in the FUTURE 5 study. Here, we report 2-year (end-of-study) results from this study.

Methods: Adults with active PsA were randomised 2:2:2:3 to receive subcutaneous secukinumab 300 mg load (300 mg), 150 mg load (150 mg), 150 mg no load or placebo at baseline; weeks 1, 2, 3 and 4; and every 4 weeks thereafter.

Appendectomy versus antibiotic treatment for acute appendicitis.

This Cochrane review has been withdrawn. The Cochrane review is out of date and included a retracted article in the analysis. Withdrawn by Cochrane Colorectal Group.

Planned Cesarean or planned vaginal delivery for twins: secondary analysis of randomized controlled trial.

Objective: To evaluate whether there is a differential benefit of planned Cesarean delivery (CD) over planned vaginal delivery (VD) in women with a twin pregnancy and the first twin in cephalic presentation, depending on prespecified baseline maternal and pregnancy characteristics, and/or gestational age (GA) at delivery.

Methods: This was a secondary analysis of the Twin Birth Study, which included 2804 women with a twin pregnancy and the first twin (Twin A) in cephalic presentation between 32 + 0 and 38 + 6 weeks' gestation at 106 centers in 25 countries. Women were assigned randomly to either planned CD or planned VD.

Cost-Effectiveness Analysis of Peripheral Nerve Field Stimulation as Add-On Therapy to Spinal Cord Stimulation in the Treatment of Chronic Low Back Pain in Failed Back Surgery Syndrome Patients.

Objective: Presently, there is only limited evidence about the cost-effectiveness of peripheral nerve field stimulation (PNFS) and no evidence to date on the cost-effectiveness of PNFS as an add-on therapy to spinal cord stimulation (SCS). In a multicenter randomized controlled trial, PNFS as add-on therapy to SCS demonstrated clinical effectiveness in treating chronic low back pain in failed back surgery syndrome (FBSS) patients. We report here the cost-effectiveness of PNFS as additional therapy.

Postnatal Catch-Up Growth After Suspected Fetal Growth Restriction at Term.

The aim of this study was to study growth patterns of children born after suspected fetal growth restriction (FGR) at term and to compare the effect of induction of labor (IoL) and expectant management (EM), also in relation to neurodevelopmental and behavioral outcome at age 2. We performed a 2 years' follow-up of growth of children included in the Disproportionate Intrauterine Growth Restriction Trial at Term (DIGITAT) study, a Randomized Controlled Trial (RCT) comparing IoL with EM in pregnancies with suspected FGR at term. We collected data on child growth until the age of 2 years.

Impact of baseline C-reactive protein levels on the response to secukinumab in ankylosing spondylitis: 3-year pooled data from two phase III studies.

Objective: To evaluate the magnitude of response to secukinumab treatment over 3 years in patients with ankylosing spondylitis (AS) grouped by baseline C-reactive protein (CRP) levels in a pooled study of two pivotal phase III studies: MEASURE 1 (NCT01358175) and MEASURE 2 (NCT01649375).

Methods: This post hoc analysis pooled data from all patients with available baseline CRP in the two studies who received subcutaneous secukinumab 150  mg (approved dose; N=197) or placebo (N=195). Assessed efficacy endpoints included Assessments of SpondyloArthritis international Society (ASAS)20/40, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI50, AS Disease Activity Score inactive disease and ASAS partial remission among patients grouped by baseline CRP based on central laboratory cut-off <5  mg/L (normal) or ≥5  mg/L (elevated) and a cut-off <10  mg/L or ≥10  mg/L.

Use of high-dose intermittent systemic glucocorticoids and the risk of fracture in patients with chronic obstructive pulmonary disease.

Introduction: Chronic obstructive pulmonary disease (COPD) is characterised by persistent airflow obstruction and respiratory symptoms. While short course systemic GCs are prescribed in patients with acute COPD exacerbations, little is known of the risk of fractures with intermittent exposure to high-dose GC and the effect of proxies of disease severity.

Methods: A case-control study was conducted using the Danish National Hospital Discharge Registry (NHDR) between January 1996 to December 2011.

Adipose tissue macrophages induce hepatic neutrophil recruitment and macrophage accumulation in mice.

Objective: Obesity is a risk factor for non-alcoholic steatohepatitis (NASH). This risk has been attributed to visceral adipose tissue (vAT) expansion associated with increased proinflammatory mediators. Accumulation of CD11c proinflammatory adipose tissue macrophages (ATM) is an important driver of vAT inflammation.

Procalcitonin-guided decision making for duration of antibiotic therapy in neonates with suspected early-onset sepsis: a multicentre, randomised controlled trial (NeoPIns).

Background: Up to 7% of term and late-preterm neonates in high-income countries receive antibiotics during the first 3 days of life because of suspected early-onset sepsis. The prevalence of culture-proven early-onset sepsis is 0·1% or less in high-income countries, suggesting substantial overtreatment. We assess whether procalcitonin-guided decision making for suspected early-onset sepsis can safely reduce the duration of antibiotic treatment.

The performance of different classification criteria sets for spondyloarthritis in the worldwide ASAS-COMOSPA study.

Background: In this study, we sought to compare the performance of spondyloarthritis (SpA) classification criteria sets in an international SpA cohort with patients included from five continents around the world.

Methods: Data from the (ASAS) COMOrbidities in SPondyloArthritis (ASAS-COMOSPA) study were used. ASAS-COMOSPA is a multinational, cross-sectional study with consecutive patients diagnosed with SpA by rheumatologists worldwide.

Surgery versus conservative management for recurrent and ongoing left-sided diverticulitis (DIRECT trial): an open-label, multicentre, randomised controlled trial.

Background: Patients with recurrent or persisting complaints after an episode of left-sided diverticulitis are managed with either conservative measures or elective sigmoidectomy. To date, there are no data from randomised trials. We aimed to establish which treatment leads to a better quality of life for patients with diverticulitis.

Clinical validation of a body-fixed 3D accelerometer and algorithm for activity monitoring in orthopaedic patients.

Background/objective: Activity is increasingly being recognized as a highly relevant parameter in all areas of healthcare for diagnosis, treatment, or outcome assessment, especially in orthopaedics where the movement apparatus is directly affected. Therefore, the aim of this study was to develop, describe, and clinically validate a generic activity-monitoring algorithm, satisfying a combination of three criteria. The algorithm must be able to identify, count, and time a large set of relevant daily activities.

The expansion and performance of national newborn screening programmes for cystic fibrosis in Europe.

Background: Newborn screening (NBS) for cystic fibrosis (CF) is a well-established public health strategy with international standards. The aim of this study was to provide an update on NBS for CF in Europe and assess performance against the standards.

Methods: Questionnaires were sent to key workers in each European country.

Incidence of Iatrogenic Ureteral Injury During Open and Laparoscopic Colorectal Surgery: A Single Center Experience and Review of the Literature.

Introduction: Iatrogenic ureteral injury is a rare but potentially devastating complication of colorectal surgery. We evaluated the incidence and management of iatrogenic ureteral injuries in colorectal surgery during the transition phase from open to laparoscopic surgery.

Materials And Methods: We conducted a retrospective single center study.

Symptomatic abdominal aortic aneurysm repair: to wait or not to wait.

Background: In patients with a symptomatic abdominal aortic aneurysm (sAAA), acute intervention theoretically reduces rupture risk prior to surgery whereas delayed intervention provides surgery under optimised conditions. In the present study we evaluated differences in 30-day mortality in patients with a sAAA operated within 12 hours compared to patients who received treatment after 12 hours and who were optimized for surgery.

Methods: All patients with a sAAA who were treated within one week after presentation were included in the analyses.

FDG-PET/CT Limited to the Thorax and Upper Abdomen for Staging and Management of Lung Cancer.

Purpose: This study evaluates the diagnostic accuracy of [F-18]-fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT) of the chest/upper abdomen compared to the generally performed scan from head to upper thighs, for staging and management of (suspected) lung cancer in patients with no history of malignancy or complaints outside the thorax.

Methods: FDG-PET/CT scans of 1059 patients with suspected or recently proven lung cancer, with no history of malignancy or complaints outside the thorax, were analysed in a retrospective multi-centre trial. Suspect FDG-avid lesions in the chest and upper abdomen, the head and neck area above the shoulder line and in the abdomen and pelvis below the caudal tip of the liver were noted.

Predictive criteria for MRI-based evaluation of response both during and after radiotherapy for cervical cancer.

Purpose: For cervical carcinoma, the presence of persistent disease after radiotherapy (RT) is a significant predictor for survival. To date, no standard protocol is available to evaluate a response. This study was performed to assess magnetic resonance imaging (MRI) to evaluate presence of local residual disease during and after RT for Federation of Gynecology and Obstetrics (FIGO) stage Ib1-IVa cervical cancer.

Radiological Prediction of Posttraumatic Kyphosis After Thoracolumbar Fracture.

Objectives: Classification methods that are currently being used for clinical decision making in thoracolumbar fractures, are limited by reproducibility and prognostic value. Additionally, they do not include kyphosis. As a posttraumatic kyphosis is related to persistent pain, it is of importance to determine a risk of posttraumatic kyphosis based on fracture type and patient characteristics.

Poor symptom and performance validity in regularly referred Hospital outpatients: Link with standard clinical measures, and role of incentives.

We investigated the frequency of symptom validity test (SVT) failure and its clinical correlates in a large, heterogeneous sample of hospital outpatients referred for psychological assessment for clinical purposes. We studied patients (N=469), who were regularly referred for assessment to the psychology departments of five hospitals. Background characteristics, including information about incentives, were obtained with a checklist completed by the clinician.

Publications on Peripheral Nerve Injuries during World War I: A Dramatic Increase in Knowledge.

Publications from French (Jules Tinel and Chiriachitza Athanassio-Bénisty), English (James Purves-Stewart, Arthur Henry Evans and Hartley Sidney Carter), German (Otfrid Foerster and Hermann Oppenheim) and American (Charles Harrison Frazier and Byron Stookey) physicians from both sides of the front during World War I (WWI) contributed to a dramatic increase in knowledge about peripheral nerve injuries. Silas Weir Mitchell's original experience with respect to these injuries, and particularly causalgia, during the American Civil War was further expanded in Europe during WWI. Following the translation of one of his books, he was referred to mainly by French physicians.

Cardiotoxicity and Cardiac Monitoring During Adjuvant Trastuzumab in Daily Dutch Practice: A Study of the Southeast Netherlands Breast Cancer Consortium.

Introduction: We assessed the incidence and timing of first cardiac events, impact on trastuzumab prescription, and role of left ventricular ejection fraction (LVEF) monitoring in daily practice of trastuzumab-treated patients with human epidermal growth receptor 2 (HER2)-positive early breast cancer.

Methods: We included all patients with stage I-III breast cancer diagnosed in the early years (2005-2007) after the introduction of adjuvant trastuzumab in five hospitals in Southeast Netherlands. We studied the incidence and timing of cardiotoxicity in patients treated with adjuvant trastuzumab, using similar cardiac endpoints as in the Herceptin Adjuvant (HERA) trial.

Automated and Semiautomated Segmentation of Rectal Tumor Volumes on Diffusion-Weighted MRI: Can It Replace Manual Volumetry?

Purpose: Diffusion-weighted imaging (DWI) tumor volumetry is promising for rectal cancer response assessment, but an important drawback is that manual per-slice tumor delineation can be highly time consuming. This study investigated whether manual DWI-volumetry can be reproduced using a (semi)automated segmentation approach.

Methods And Materials: Seventy-nine patients underwent magnetic resonance imaging (MRI) that included DWI (highest b value [b1000 or b1100]) before and after chemoradiation therapy (CRT).

An economic analysis of immediate delivery and expectant monitoring in women with hypertensive disorders of pregnancy, between 34 and 37 weeks of gestation (HYPITAT-II).

Objective: To assess the economic consequences of immediate delivery compared with expectant monitoring in women with preterm non-severe hypertensive disorders of pregnancy.

Design: A cost-effectiveness analysis alongside a randomised controlled trial (HYPITAT-II).

Setting: Obstetric departments of seven academic hospitals and 44 non-academic hospitals in the Netherlands.

Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial.

Background: Labour is induced in 20-30% of all pregnancies. In women with an unfavourable cervix, both oral misoprostol and Foley catheter are equally effective compared with dinoprostone in establishing vaginal birth, but each has a better safety profile. We did a trial to directly compare oral misoprostol with Foley catheter alone.