a scoping review

Funding Information: This work was partly supported by funds from the EU funded COST Action EVBRES ( CA17117 ) and internal funds from Danube University Krems . Funding Information: This scoping review is part of working group 3’s work within the EVBRES (EVidence-Based RESearch) – COST Action CA17117, funded by the European Union ( www.evbres.eu ). The protocol for this scoping review was published a priori via the Open Science Framework ( https://osf.io/fby54/ ) [11] . Publisher Copyright: © 2021 The Author(s)Objective: We aimed to map the resource use during systematic review (SR) production and reasons why steps of the SR production are resource intensive to discover where the largest gain in improving efficiency might be possible. Study design and setting: We conducted a scoping review. An information specialist searched multiple databases (e.g., Ovid MEDLINE, Scopus) and implemented citation-based and grey literature searching. We employed dual and independent screenings of records at the title/abstract and full-text levels and data extraction. Results: We included 34 studies. Thirty-two reported on the resource use—mostly time; four described reasons why steps of the review process are resource intensive. Study selection, data extraction, and critical appraisal seem to be very resource intensive, while protocol development, literature search, or study retrieval take less time. Project management and administration required a large proportion of SR production time. Lack of experience, domain knowledge, use of collaborative and SR-tailored software, and good communication and management can be reasons why SR steps are resource intensive. Conclusion: Resource use during SR production varies widely. Areas with the largest resource use are administration and project management, study selection, data extraction, and critical appraisal of studies.publishersversionpublishe

Use of biologics for the management of Crohn's disease: IG-IBD clinical guidelines based on the GRADE methodology

A cure for Crohn's disease (CD), a chronic inflammatory disease of the gastrointestinal tract of unknown etiology, is not available, so patients require lifelong management to keep inflammation under control. The therapeutic armamentarium has expanded with approval of several biological drugs, including in-fliximab, adalimumab, vedolizumab and ustekinumab - monoclonal antibodies that target different in-flammatory pathways - and darvadstrocel, a suspension of expanded human allogeneic, adipose-derived, mesenchymal stromal cells for the treatment of refractory complex perianal fistula. Notwithstanding ex-isting practice guidelines on medical therapy for CD, the Italian Group for the Study of Inflammatory Bowel Disease felt the need to issue new guidelines focused on the use of biologics for managing the intestinal manifestations of CD and based on the GRADE methodology. This document presents recom-mendations regarding six clinical settings, from the induction to the maintenance of clinical remission, and from optimization and de-escalation of treatments to dealing with perianal CD and post-operative recurrence. The 19 evidence-based statements are supported by information on the quality of the evi-dence, agreement rate among panel members, and panel comments mainly based on evidence from real world studies

Clinical relevance and practical implications of trials of perfusion and angiographic imaging in patients with acute ischaemic stroke:a multicentre cohort imaging study

Peer reviewedPublisher PD

ASD and schizophrenia show distinct developmental profiles in common genetic overlap with population-based social communication difficulties

Difficulties in social communication are part of the phenotypic overlap between autism spectrum disorders (ASD) and schizophrenia. Both conditions follow, however, distinct developmental patterns. Symptoms of ASD typically occur during early childhood, whereas most symptoms characteristic of schizophrenia do not appear before early adulthood. We investigated whether overlap in common genetic in fluences between these clinical conditions and impairments in social communication depends on the developmental stage of the assessed trait. Social communication difficulties were measured in typically-developing youth (Avon Longitudinal Study of Parents and Children,N⩽5553, longitudinal assessments at 8, 11, 14 and 17 years) using the Social Communication Disorder Checklist. Data on clinical ASD (PGC-ASD: 5305 cases, 5305 pseudo-controls; iPSYCH-ASD: 7783 cases, 11 359 controls) and schizophrenia (PGC-SCZ2: 34 241 cases, 45 604 controls, 1235 trios) were either obtained through the Psychiatric Genomics Consortium (PGC) or the Danish iPSYCH project. Overlap in genetic in fluences between ASD and social communication difficulties during development decreased with age, both in the PGC-ASD and the iPSYCH-ASD sample. Genetic overlap between schizophrenia and social communication difficulties, by contrast, persisted across age, as observed within two independent PGC-SCZ2 subsamples, and showed an increase in magnitude for traits assessed during later adolescence. ASD- and schizophrenia-related polygenic effects were unrelated to each other and changes in trait-disorder links reflect the heterogeneity of genetic factors in fluencing social communication difficulties during childhood versus later adolescence. Thus, both clinical ASD and schizophrenia share some genetic in fluences with impairments in social communication, but reveal distinct developmental profiles in their genetic links, consistent with the onset of clinical symptom

Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3.

Purpose Evolving treatments, disease phenotypes, and biology, together with a changing drug development environment, have created the need to revise castration-resistant prostate cancer (CRPC) clinical trial recommendations to succeed those from prior Prostate Cancer Clinical Trials Working Groups.Methods An international expert committee of prostate cancer clinical investigators (the Prostate Cancer Clinical Trials Working Group 3 [PCWG3]) was reconvened and expanded and met in 2012-2015 to formulate updated criteria on the basis of emerging trial data and validation studies of the Prostate Cancer Clinical Trials Working Group 2 recommendations.Results PCWG3 recommends that baseline patient assessment include tumor histology, detailed records of prior systemic treatments and responses, and a detailed reporting of disease subtypes based on an anatomic pattern of metastatic spread. New recommendations for trial outcome measures include the time to event end point of symptomatic skeletal events, as well as time to first metastasis and time to progression for trials in the nonmetastatic CRPC state. PCWG3 introduces the concept of no longer clinically benefiting to underscore the distinction between first evidence of progression and the clinical need to terminate or change treatment, and the importance of documenting progression in existing lesions as distinct from the development of new lesions. Serial biologic profiling using tumor samples from biopsies, blood-based diagnostics, and/or imaging is also recommended to gain insight into mechanisms of resistance and to identify predictive biomarkers of sensitivity for use in prospective trials.Conclusion PCWG3 moves drug development closer to unmet needs in clinical practice by focusing on disease manifestations most likely to affect prognosis adversely for therapeutics tested in both nonmetastatic and metastatic CRPC populations. Consultation with regulatory authorities is recommended if a trial is intended to seek support for drug approval

How aware is the public of the existence, characteristics and causes of language impairment in childhood and where have they heard about it? A European survey

Public awareness of language impairment in childhood (Developmental Language Disorder (DLD)) has been identified as an important determiner of research and clinical service delivery, yet studies directly assessing public awareness are lacking. This study surveyed awareness across 18 countries of Europe.Method: A questionnaire developed by an international team asked whether respondents had heard of language impairment affecting children, what they thought its manifestations and causes were and where they had heard of it. Respondents were also asked whether they had heard of autism, dyslexia, ADD/ADHD and speech disorder. The questionnaire was administered to members of the public in 18 European countries. A total of 1519 responses were obtained, spanning 6 age groups, 4 educational level groups and 3 income level groups.Results: Across all but one country, significantly fewer people had heard of language impairment than any of the other disorders (or 60 % compared to over 90 % for autism). Awareness tended to be lowest in Eastern Europe and greatest in North-Western Europe, and was influenced by education level, age and income level. People in countries with overall low and overall high awareness differed in their views on manifestations and causes. People had heard of language impairment and autism the same way - most frequently through the media, including Internet, and less frequently through their child’s school or a medical professional.Discussion: The study confirms that awareness of language impairment and knowledge of the breadth of its manifestations are low. It also suggests opportunities for how to increase awareness, including greater media coverage of language impairment and more efficient use of venues such as schools and healthcare. Ways in which cultural and linguistic differences may influence public awareness efforts are discussed, including the translatability of clinical labels and scientific terms. These may impact the acceptance of a common term and definition across all countries. As awareness campaigns are gaining momentum, the findings of this study can serve as a baseline against which to compare future findings.peer-reviewe