SummaryBackgroundRemote ischaemic conditioning with transient ischaemia and reperfusion applied to the arm has been shown to reduce myocardial infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). We investigated whether remote ischaemic conditioning could reduce the incidence of cardiac death and hospitalisation for heart failure at 12 months.MethodsWe did an international investigator-initiated, prospective, single-blind, randomised controlled trial (CONDI-2/ERIC-PPCI) at 33 centres across the UK, Denmark, Spain, and Serbia. Patients (age >18 years) with suspected STEMI and who were eligible for PPCI were randomly allocated (1:1, stratified by centre with a permuted block method) to receive standard treatment (including a sham simulated remote ischaemic conditioning intervention at UK sites only) or remote ischaemic conditioning treatment (intermittent ischaemia and reperfusion applied to the arm through four cycles of 5-min inflation and 5-min deflation of an automated cuff device) before PPCI. Investigators responsible for data collection and outcome assessment were masked to treatment allocation. The primary combined endpoint was cardiac death or hospitalisation for heart failure at 12 months in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02342522) and is completed.FindingsBetween Nov 6, 2013, and March 31, 2018, 5401 patients were randomly allocated to either the control group (n=2701) or the remote ischaemic conditioning group (n=2700). After exclusion of patients upon hospital arrival or loss to follow-up, 2569 patients in the control group and 2546 in the intervention group were included in the intention-to-treat analysis. At 12 months post-PPCI, the Kaplan-Meier-estimated frequencies of cardiac death or hospitalisation for heart failure (the primary endpoint) were 220 (8·6%) patients in the control group and 239 (9·4%) in the remote ischaemic conditioning group (hazard ratio 1·10 [95% CI 0·91–1·32], p=0·32 for intervention versus control). No important unexpected adverse events or side effects of remote ischaemic conditioning were observed.InterpretationRemote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI.FundingBritish Heart Foundation, University College London Hospitals/University College London Biomedical Research Centre, Danish Innovation Foundation, Novo Nordisk Foundation, TrygFonden.

Preregistration is a method to increase research transparency by documenting research decisions on a public, third-party repository prior to any influence by data. It is becoming increasingly popular in all subfields of psychology and beyond. Adherence to the preregistration plan may not always be feasible and even is not necessarily desirable, but without disclosure of deviations, readers who do not carefully consult the preregistration plan might get the incorrect impression that the study was exactly conducted and reported as planned. In this paper, we have investigated adherence and disclosure of deviations for all articles published with the Preregistered badge in Psychological Science between February 2015 and November 2017 and shared our findings with the corresponding authors for feedback. Two out of 27 preregistered studies contained no deviations from the preregistration plan. In one study, all deviations were disclosed. Nine studies disclosed none of the deviations. We mainly observed (un)disclosed deviations from the plan regarding the reported sample size, exclusion criteria and statistical analysis. This closer look at preregistrations of the first generation reveals possible hurdles for reporting preregistered studies and provides input for future reporting guidelines. We discuss the results and possible explanations, and provide recommendations for preregistered research.

We investigated the reproducibility of the major statistical conclusions drawn in 46 articles published in 2012 in three APA journals. After having identified 232 key statistical claims, we tried to reproduce, for each claim, the test statistic, its degrees of freedom, and the corresponding p value, starting from the raw data that were provided by the authors and closely following the Method section in the article. Out of the 232 claims, we were able to successfully reproduce 163 (70%), 18 of which only by deviating from the article's analytical description. Thirteen (7%) of the 185 claims deemed significant by the authors are no longer so. The reproduction successes were often the result of cumbersome and time-consuming trial-and-error work, suggesting that APA style reporting in conjunction with raw data makes numerical verification at least hard, if not impossible. This article discusses the types of mistakes we could identify and the tediousness of our reproduction efforts in the light of a newly developed taxonomy for reproducibility. We then link our findings with other findings of empirical research on this topic, give practical recommendations on how to achieve reproducibility, and discuss the challenges of large-scale reproducibility checks as well as promising ideas that could considerably increase the reproducibility of psychological research.

Unexpected difficult airway management can cause significant morbidity and mortality in patients admitted for elective procedures. Ultrasonography is a promising tool for perioperative airway assessment, nevertheless it is still unclear which sonographic parameters are useful predictors of difficult laryngoscopy and tracheal intubation. To determine the ultrasonographic predictors of a difficult airway that could be applied for routine practice, a systematic review and meta-analysis was conducted. Literature search was performed on PubMED, Web of Science and Embase using the selected keywords. Human primary studies, published in English with the use of ultrasonography to prediction of difficult laryngoscopy or tracheal intubation were included. A total of 19 articles (4,570 patients) were analyzed for the systematic review and 12 articles (1,141 patients) for the meta-analysis. Standardized mean differences between easy and difficult laryngoscopy groups were calculated and the parameter effect size quantified. A PRISMA methodology was used and the critical appraisal tool from Joanna Briggs Institute was applied. Twenty-six sonographic parameters were studied. The overall effect of the distance from skin to hyoid bone (p = 0.02); skin to epiglottis (p = 0.02); skin to the anterior commissure of vocal cords (p = 0.02), pre-epiglottis space to distance between epiglottis and midpoint between vocal cords (p = 0.01), hyomental distance in neutral (p < 0.0001), and extended (p = 0.0002) positions and ratio of hyomental distance in neutral to extended (p = 0.001) was significant. This study shows that hyomental distance in the neutral position is the most reliable parameter for pre-operative airway ultrasound assessment. The main limitations of the study are the small sample size, heterogeneity of studies, and absence of a standardized ultrasonographic evaluation method [Registered at International prospective register of systematic reviews (PROSPERO): number 167931].

Xanthogranulomatous pyelonephritis (XPN) is an uncommon variant of chronic pyelonephritis with a poorly understood pathogenesis and a challenging diagnosis. It is rare in pediatric patients, particularly in the neonatal period. We report the case of an 18-day-old female neonate admitted to the emergency room due to macroscopic hematuria and poor feeding. Urinalysis revealed leukocyturia and she was initially admitted under the clinical suspicion of acute pyelonephritis. Renal ultrasound and magnetic resonance imaging (MRI) revealed a progressive nodular lesion in the middle third of the left kidney. Given the suspicion of renal abscess or neoplasm, the patient was transferred to our tertiary hospital. Urinary catecholamines and tumor markers had normal values. Percutaneous kidney biopsy confirmed XPN. Posterior computed tomography scan excluded extension to neighboring structures. A conservative management with systemic antibiotic therapy was decided. She completed 7 weeks of systemic antibiotic therapy (ampicillin and cefotaxime) with progressive reduction of lesion size and posterior calcification. Follow-up at 3 years was uneventful. The lipid profile and study of neutrophil function were normal. Voiding cystourethrography excluded vesicoureteral reflux. The authors intend to highlight the importance of a high index of suspicion of XPN to allow preoperative diagnosis. Histopathological assessment is mandatory to confirm XPN and exclude other entities mimicked by focal and unilateral progressive disease. There are only a few published cases of optimal clinical evolution solely with broad-spectrum antibiotics; however, this may allow a beneficial nephron-sparing approach in selected patients.