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The Evaluation of Genomic Applications in Practice and Prevention Working Group was first convened in 2005 to develop and test evidence-based methods for the evaluation of genomic tests in transition from research to clinical and public health practice. Over the ensuing years, the Working Group has met 26 times, publishing eight recommendation statements, two methods papers, and one outcomes paper, as well as planning and serving as technical experts on numerous associated systematic reviews. Evaluation of Genomic Applications in Practice and Prevention methods have evolved to address implications of the proliferation of genome-wide association studies and are currently expanding to face challenges expected from clinical implementation of whole-genome sequencing tests. In this article, we review the work of the Evaluation of Genomic Applications in Practice and Prevention Working Group over the first 8 years of its existence with an emphasis on lessons learned throughout the process. It is hoped that in addition to the published methods of the Working Group, the lessons we have learned along the way will be informative to others who are producers and consumers of evidence-based guidelines in the field of genomic medicine.

Abstract Background Systematic reviews of health interventions are increasingly incorporating evidence outside of randomized controlled trials (RCT). While non-randomized study (NRS) types may be more prone to bias compared to RCT, the tools used to evaluate risk of bias (RoB) in NRS are less straightforward and no gold standard tool exists. The objective of this study was to evaluate the planned use of RoB tools in systematic reviews of health interventions, specifically for reviews that planned to incorporate evidence from RCT and/or NRS. Methods We evaluated a random sample of non-Cochrane protocols for systematic reviews of interventions registered in PROSPERO between January 1 and October 12, 2018. For each protocol, we extracted data on the types of studies to be included (RCT and/or NRS) as well as the name and number of RoB tools planned to be used according to study design. We then conducted a longitudinal analysis of the most commonly reported tools in the random sample. Using keywords and name variants for each tool, we searched PROSPERO records by year since the inception of the database (2011 to December 7, 2018), restricting the keyword search to the “Risk of bias (quality) assessment” field. Results In total, 471 randomly sampled PROSPERO protocols from 2018 were included in the analysis. About two-thirds (63%) of these planned to include NRS, while 37% restricted study design to RCT or quasi-RCT. Over half of the protocols that planned to include NRS listed only a single RoB tool, most frequently the Cochrane RoB Tool. The Newcastle-Ottawa Scale and ROBINS-I were the most commonly reported tools for NRS (39% and 33% respectively) for systematic reviews that planned to use multiple RoB tools. Looking at trends over time, the planned use of the Cochrane RoB Tool and ROBINS-I seems to be increasing. Conclusions While RoB tool selection for RCT was consistent, with the Cochrane RoB Tool being the most frequently reported in PROSPERO protocols, RoB tools for NRS varied widely. Results suggest a need for more education and awareness on the appropriate use of RoB tools for NRS. Given the heterogeneity of study designs comprising NRS, multiple RoB tools tailored to specific designs may be required.

Abstract Background Several hundred core outcome set (COS) projects have been systematically identified to date which, if adopted, ensure that researchers measure and report those outcomes that are most likely to be relevant to users of their research. The uptake of a COS by COS users will depend in part on the transparency and robustness of the methods used in the COS development study, which would be increased by the use of a standardised protocol. This article describes the development of the COS-STAP (Core Outcome Set-STAndardised Protocol Items) Statement for the content of a COS development study protocol. Methods The COS-STAP Statement was developed following the Enhancing the Quality and Transparency Of Health Research (EQUATOR) Network’s methodological framework for guideline development. This included an initial item generation stage, a two-round Delphi survey involving more than 150 participants representing three stakeholder groups (COS developers, journal editors and patient and public involvement researchers interested in COS development), followed by a consensus meeting with eight voting participants. Results The COS-STAP Statement consists of a checklist of 13 items considered essential documentation in a protocol, outlining the scope of the COS, stakeholder involvement, COS development plans and consensus processes. Conclusions Journal editors and peer reviewers can use the guidance to assess the completeness of a COS development study protocol submitted for publication. By providing guidance for key content, the COS-STAP Statement will enhance the drafting of high-quality protocols and determine how the COS development study will be carried out.

The COVID-19 pandemic has exposed social inequities that rival biological inequities in disease exposure and severity. Merely identifying some inequities without understanding all of them can lead to harmful misrepresentations and deepening disparities. Applying an ‘equity lens’ to bring inequities into focus without a vision to extinguish them is short-sighted. Interventions to address inequities should be as diverse as the pluralistic populations experiencing them. We present the first validated equity framework applied to COVID-19 that sheds light on the full spectrum of health inequities, navigates their sources and intersections, and directs ethically just interventions. The Equity Matrix also provides a comprehensive map to guide surveillance and research in order to unveil epidemiological uncertainties of novel diseases like COVID-19, recognising that inequities may exist where evidence is currently insufficient. Successfully applied to vaccines in recent years, this tool has resulted in the development of clear, timely and transparent guidance with positive stakeholder feedback on its comprehensiveness, relevance and appropriateness. Informed by evidence and experience from other vaccine-preventable diseases, this Equity Matrix could be valuable to countries across the social gradient to slow the spread of SARS-CoV-2 by abating the spread of inequities. In the race to SARS-CoV-2 vaccines, this urgently needed roadmap can effectively and efficiently steer global leadership towards equitable allocation with diverse strategies for diverse inequities. Such a roadmap has been absent from discussions on managing the COVID-19 pandemic, and is critical for our passage out of it.

The current study investigated the coexistence of temporomandibular disorder (TMD) and/or bruxism among 51 individuals seeking treatment in a tinnitus clinic. All participants completed a Hebrew version of the Tinnitus Handicap Inventory (THI), depression and anxiety questionnaires, and the diagnostic criteria TMD (DC/TMD) questionnaire. In addition to questionnaires, the participants underwent a clinical evaluation of the oral cavity, facial muscles, and the temporomandibular joint (TMJ). Thirty-four participants (66.7%) were diagnosed with bruxism, while TMD was found in 14 (27.5%) of the cases. Patients with both tinnitus, TMD and bruxism scored the highest in the anxiety questionnaire. The severity of depression was found to be significantly associated with the tinnitus severity. These results emphasize the clinical bond between tinnitus, TMD, and bruxism.

Pragmatic clinical trials (PCTs) seek to improve the generalizability and increase the statistical power of traditional explanatory trials. They are a major tenet of comparative effectiveness research. While a powerful study design, PCTs have been limited by high cost, modest efficiency, and limited ability to fill relevant evidence gaps. Based on an American Reinvestment and Recovery Act (ARRA) supported meeting of national stakeholders, we propose several innovations and future research that could improve the efficiency and effectiveness of such studies focused in the U.S. Innovations discussed include optimizing the use of community based practices through partnership with Practice Based Research Networks (PBRNs), using information technology to simplify PCT subject recruitment, consent and randomization processes, and utilizing linkages to large administrative databases, such as Medicare, as a mechanism to capture outcomes and other important PCT variables with lower subject and research team burden. Testing and adaptation of such innovations to PCT are anticipated to improve the public health value of these increasingly important studies.

Abstract Background There is a need for more Comparative Effectiveness Research (CER) to strengthen the evidence base for clinical and policy decision-making. Effectiveness Guidance Documents (EGD) are targeted to clinical researchers. The aim of this EGD is to provide specific recommendations for the design of prospective acupuncture studies to support optimal use of resources for generating evidence that will inform stakeholder decision-making. Methods Document development based on multiple systematic consensus procedures (written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders including patients, clinicians and payers were involved. Results Recommendations focused mainly on randomized studies and were developed for the following areas: overall research strategy, treatment protocol, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. Conclusion The present EGD, based on an international consensus developed with multiple stakeholder involvement, provides the first systematic methodological guidance for future CER on acupuncture.

he aim of this work is the stratigraphic revision of the sequences outcropping on the southwestern side of the M. Mia — M. Matajur anticline. This area, until now, was poorly studied from a geological point of view. Norian to Lower Cuisian strata were recognized, With two hiatuses in the Early and Late Cretaceous. Lithological, biostratigraphical and sedimentological characteristics are described related to formations already known from the bibliography ("Dolomia Principale", "Calcare del Dachstein" and "Calcare di Soccher") while two new Mesozoic carbonatic units are defined; ' 'Calcari della Fornace" (Lower Liassic—Tithonian) and "Calcareniti di Linder" (Berriasian—Albian). Furthermore several new informal units within the clastic Sequences are differentiated: six Maastrichtian units C 'BrecCia di Montefosca", "Marne Rosse di S. Andrea", "Flysch di Paceida", "Calcareniti di Mersino", "Flysch di M. Brieka" and "Calcareniti di M. Tomba"), three Paleocenic units ("Flysch di Calla", "Flysch di Masarolis" and "Megastrato di M. loanaz"), one Paleocenic—Eocenic unit ("Flysch di Canebola").

This paper deals with the stratigraphy of well SPAN 1 (San Pietro al Natisone, Eastern Friuli). The stratigraphic sequence is composed by Paleocenic flysch deposits (from 69 m to 748 m), Maastrichtian resedimented carbonates (from 748 m to 940 m) and Late Jurassic reef deposits (from 940 m to 1397 m, total depth). The tectonic and sedimentary evolution of the Valle del Natisone, from the Oxfordian to the Early Eocene, is outlined.

Pure and Nickel oxide doped chromium (III) oxide (Cr2O3) nanoparticals are synthesized by hydrothermal technique. The effect of dopant Ni concentration on the structural behavior of Cr2O3 nanoparticles was examined by X-ray diffraction. The average crystallite size of the synthesized nanoparticles was measured from XRD patterns using Scherrer equation and was decreased from 22nm to 12.9 nm with the increasing Nio concentration in Cr2O3 from (0, 0.01, 0.06, and 0.10). Morphologies and compositional elements of the synthesized nanoparticles were observed by the field emission scanning electron microscopy (FESEM) and energy dispersive X-ray (EDX) spectroscopy, respectively. The optical property of the samples was measured by ultraviolet - visible (UV-Vis.) absorption spectroscopy. The observed optical band gap value ranges from 2.3eV to 2.5eV for Ni doped nanoparticles

Abstract Background Type 2 diabetes is characterised by abnormal glucose metabolism, and treatment is aimed at normalising glycaemia. Outcomes measured in clinical trials should be meaningful to patients, health care professionals and researchers, yet there is heterogeneity in the outcomes used across trials of glucose-lowering interventions. This inconsistency affects the ability to compare findings and may mean that the results have little importance to health care professionals and the patients for whom they care. The SCORE-IT study aims to develop a core outcome set (COS) for use in all trials of glucose-lowering interventions for people with type 2 diabetes. Methods/design This study will involve three key stages in the development of a COS: (1) A list of outcomes will be identified from multiple sources, specifically registered clinical trials, online patient resources, the qualitative literature and landmark studies identified by a Study Steering Committee. (2) The list of outcomes will be scored by multiple stakeholder groups in a two-round online international Delphi survey. (3) The results of the online Delphi will be summarised and discussed at a face-to-face consensus meeting with representation from all stakeholder groups. Discussion The SCORE-IT study aims to develop an internationally relevant set of core outcomes for use in future trials of glucose-lowering interventions for type 2 diabetes. The use of a COS will improve the consistency of outcomes, allowing results of studies to be compared and combined and for new effective treatments to made available more quickly. Trial registration The COS study, of which this is a part, is registered in the Core Outcome Measures in Effectiveness Trials (COMET) database, http://www.comet-initiative.org/studies/details/956. Registered January 2017.