Validation of diagnostic accuracy using digital slides in routine histopathology

Background: Robust hardware and software tools have been developed in digital microscopy during the past years for pathologists. Reports have been advocated the reliability of digital slides in routine diagnostics. We have designed a retrospective, comparative study to evaluate the scanning properties and digital slide based diagnostic accuracy. Methods: 8 pathologists reevaluated 306 randomly selected cases from our archives. The slides were scanned with a 20 × Plan-Apochromat objective, using a 3-chip Hitachi camera, resulting 0.465 μm/pixel resolution. Slide management was supported with dedicated Data Base and Viewer software tools. Pathologists used their office PCs for evaluation and reached the digital slides via intranet connection. The diagnostic coherency and uncertainty related to digital slides and scanning quality were analyzed. Results: Good to excellent image quality of slides was recorded in 96%. In half of the critical 61 digital slides, poor image quality was related to section folds or floatings. In 88.2 % of the studied cases the digital diagnoses were in full agreement with the consensus. Out of the overall 36 incoherent cases, 7 (2.3%) were graded relevant without any recorded uncertainty by the pathologist. Excluding the non-field specific cases from each pathologist’s record this ratio was 1.76 % of all cases. Conclusions: Our results revealed that: 1) digital slide based histopathological diagnoses can be highly coherent with those using optical microscopy; 2) the competency of pathologists is a factor more important than the quality of digital slide; 3) poor digital slide quality do not endanger patient safety as these errors are recognizable by the pathologist and further actions for correction could be taken. Virtual slides: The virtual slide(s) for this article can be found here

Serious adverse events reported in placebo randomised controlled trials of oral naltrexone: a systematic review and meta-analysis

Background Naltrexone is an opioid antagonist used in many different conditions, both licensed and unlicensed. It is used at widely varying doses from 3 - 250 mg. The aim of this review was to evaluate the safety of oral naltrexone by examining the risk of serious adverse events (SAEs) in randomised controlled trials (RCTs) of naltrexone compared to placebo. Methods A systematic search of Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, other databases and clinical trials registries was undertaken up to March 2018. Parallel placebo-controlled RCTs longer than 4 weeks published after 1/1/2001, of oral naltrexone at any dose were selected. Any condition and age group were included, excluding only studies for opioid or ex-opioid users, due to possible opioid/opioid antagonist interactions. The systematic review used the guidance of the Cochrane Handbook throughout. Numerical data was independently extracted by two people and cross-checked. Risk of bias was assessed with the Cochrane Risk of Bias Tool. Meta-analyses were performed using Stata 15 and R, using random and fixed effects models throughout. Results Eighty-nine RCTs with 11194 participants were found, studying alcohol use disorders, various psychiatric disorders, impulse control disorders, other addictions, obesity, Crohn’s disease, fibromyalgia and cancers. Twenty-six studies (4,960 participants) recorded SAEs occurring by arm of study. There was no evidence of increased risk of SAEs for naltrexone compared to placebo, relative risk (RR) 0.84 (95% CI: 0.66 to 1.06). Sensitivity analyses pooling risk differences supported this conclusion (RD = -0.01 (-0.02, 0.00)) and subgroup analyses showed that results were consistent across different doses and disease groups. The quality of evidence for this outcome was judged high using the GRADE criteria. Conclusions Naltrexone does not appear to increase the risk of SAEs over placebo. These findings confirm the safety of naltrexone when used in licensed indications and encourage investments to undertake efficacy studies in unlicensed indications

ICAR: endoscopic skull‐base surgery

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Anatomia cirúrgica do acesso nasal transesfenoidal para tumores da hipófise Surgical anatomy of the nasal transphenoidal approach for pituitary tumors

Foram analisadas diferentes medidas relacionadas ao acesso nasal transesfenoidal em 18 hemicabeças de cadáveres com o objetivo de estudar os limites e vantagens dessa via. Foram obtidos os seguintes valores médios (mm) para as principais medidas: diâmetro maior da narina 15,18; altura da cavidade nasal 44,11; distância narina - sela turca 71,71. Esses valores demonstram ser o acesso nasal uma via ampla e direta à sela turca. O presente estudo demonstrou também ser possível nesse acesso preservar o septo cartilágino e outras estruturas que são usualmente lesadas no acesso sublabial.<br>Different distances related to the nasal transphenoidal approach were measured on the hemiheads of eighteen cadavers in order to study its limits and advantages. The main mean measures obtained (mm) were: major diameter of the nostril 15.18; height of the nasal cavity 44.11; nostril-sella turcica distance 71.71. These results show that the nasal approach is wide and direct to the sella turcica. The present study demonstrate the possibility of preservation of the cartilaginous septum and other structures which are usually damaged when the sublabial approach is employed