Using Social Media to Engage Knowledge Users in Health Research Priority Setting: Scoping Review.

BACKGROUND: The need to include individuals with lived experience (ie, patients, family members, caregivers, researchers, and clinicians) in health research priority setting is becoming increasingly recognized. Social media-based methods represent a means to elicit and prioritize the research interests of such individuals, but there remains sparse methodological guidance on how best to conduct these social media efforts and assess their effectiveness. OBJECTIVE: This review aims to identify social media strategies that enhance participation in priority-setting research, collate metrics assessing the effectiveness of social media campaigns, and summarize the benefits and limitations of social media-based research approaches, as well as recommendations for prospective campaigns. METHODS: We searched PubMed, Embase, Cochrane Library, Scopus, and Web of Science from database inception until September 2021. Two reviewers independently screened all titles and abstracts, as well as full texts for studies that implemented and evaluated social media strategies aimed at engaging knowledge users in research priority setting. We subsequently conducted a thematic analysis to aggregate study data by related codes and themes. RESULTS: A total of 23 papers reporting on 22 unique studies were included. These studies used Facebook, Twitter, Reddit, websites, video-calling platforms, emails, blogs, e-newsletters, and web-based forums to engage with health research stakeholders. Priority-setting engagement strategies included paid platform-based advertisements, email-embedded survey links, and question-and-answer forums. Dissemination techniques for priority-setting surveys included snowball sampling and the circulation of participation opportunities via internal members' and external organizations' social media platforms. Social media campaign effectiveness was directly assessed as number of clicks and impressions on posts, frequency of viewed posts, volume of comments and replies, number of times individuals searched for a campaign page, and number of times a hashtag was used. Campaign effectiveness was indirectly assessed as numbers of priority-setting survey responses and visits to external survey administration sites. Recommendations to enhance engagement included the use of social media group moderators, opportunities for peer-to-peer interaction, and the establishment of a consistent tone and brand. CONCLUSIONS: Social media may increase the speed and reach of priority-setting participation opportunities leading to the development of research agendas informed by patients, family caregivers, clinicians, and researchers. Perceived limitations of the approach include underrepresentation of certain demographic groups and addressing such limitations will enhance the inclusion of diverse research priority opinions in future research agendas.

Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension.

Importance: Clinicians, patients, and policy makers rely on published results from clinical trials to help make evidence-informed decisions. To critically evaluate and use trial results, readers require complete and transparent information regarding what was planned, done, and found. Specific and harmonized guidance as to what outcome-specific information should be reported in publications of clinical trials is needed to reduce deficient reporting practices that obscure issues with outcome selection, assessment, and analysis. Objective: To develop harmonized, evidence- and consensus-based standards for reporting outcomes in clinical trial reports through integration with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement. Evidence Review: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement was developed by (1) generation and evaluation of candidate outcome reporting items via consultation with experts and a scoping review of existing guidance for reporting trial outcomes (published within the 10 years prior to March 19, 2018) identified through expert solicitation, electronic database searches of MEDLINE and the Cochrane Methodology Register, gray literature searches, and reference list searches; (2) a 3-round international Delphi voting process (November 2018-February 2019) completed by 124 panelists from 22 countries to rate and identify additional items; and (3) an in-person consensus meeting (April 9-10, 2019) attended by 25 panelists to identify essential items for the reporting of outcomes in clinical trial reports. Findings: The scoping review and consultation with experts identified 128 recommendations relevant to reporting outcomes in trial reports, the majority (83%) of which were not included in the CONSORT 2010 statement. All recommendations were consolidated into 64 items for Delphi voting; after the Delphi survey process, 30 items met criteria for further evaluation at the consensus meeting and possible inclusion in the CONSORT-Outcomes 2022 extension. The discussions during and after the consensus meeting yielded 17 items that elaborate on the CONSORT 2010 statement checklist items and are related to completely defining and justifying the trial outcomes, including how and when they were assessed (CONSORT 2010 statement checklist item 6a), defining and justifying the target difference between treatment groups during sample size calculations (CONSORT 2010 statement checklist item 7a), describing the statistical methods used to compare groups for the primary and secondary outcomes (CONSORT 2010 statement checklist item 12a), and describing the prespecified analyses and any outcome analyses not prespecified (CONSORT 2010 statement checklist item 18). Conclusions and Relevance: This CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement provides 17 outcome-specific items that should be addressed in all published clinical trial reports and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results.

Guidelines for Reporting Outcomes in Trial Protocols: The SPIRIT-Outcomes 2022 Extension.

Importance: Complete information in a trial protocol regarding study outcomes is crucial for obtaining regulatory approvals, ensuring standardized trial conduct, reducing research waste, and providing transparency of methods to facilitate trial replication, critical appraisal, accurate reporting and interpretation of trial results, and knowledge synthesis. However, recommendations on what outcome-specific information should be included are diverse and inconsistent. To improve reporting practices promoting transparent and reproducible outcome selection, assessment, and analysis, a need for specific and harmonized guidance as to what outcome-specific information should be addressed in clinical trial protocols exists. Objective: To develop harmonized, evidence- and consensus-based standards for describing outcomes in clinical trial protocols through integration with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 statement. Evidence Review: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the SPIRIT-Outcomes 2022 extension of the SPIRIT 2013 statement was developed by (1) generation and evaluation of candidate outcome reporting items via consultation with experts and a scoping review of existing guidance for reporting trial outcomes (published within the 10 years prior to March 19, 2018) identified through expert solicitation, electronic database searches of MEDLINE and the Cochrane Methodology Register, gray literature searches, and reference list searches; (2) a 3-round international Delphi voting process (November 2018-February 2019) completed by 124 panelists from 22 countries to rate and identify additional items; and (3) an in-person consensus meeting (April 9-10, 2019) attended by 25 panelists to identify essential items for outcome-specific reporting to be addressed in clinical trial protocols. Findings: The scoping review and consultation with experts identified 108 recommendations relevant to outcome-specific reporting to be addressed in trial protocols, the majority (72%) of which were not included in the SPIRIT 2013 statement. All recommendations were consolidated into 56 items for Delphi voting; after the Delphi survey process, 19 items met criteria for further evaluation at the consensus meeting and possible inclusion in the SPIRIT-Outcomes 2022 extension. The discussions during and after the consensus meeting yielded 9 items that elaborate on the SPIRIT 2013 statement checklist items and are related to completely defining and justifying the choice of primary, secondary, and other outcomes (SPIRIT 2013 statement checklist item 12) prospectively in the trial protocol, defining and justifying the target difference between treatment groups for the primary outcome used in the sample size calculations (SPIRIT 2013 statement checklist item 14), describing the responsiveness of the study instruments used to assess the outcome and providing details on the outcome assessors (SPIRIT 2013 statement checklist item 18a), and describing any planned methods to account for multiplicity relating to the analyses or interpretation of the results (SPIRIT 2013 statement checklist item 20a). Conclusions and Relevance: This SPIRIT-Outcomes 2022 extension of the SPIRIT 2013 statement provides 9 outcome-specific items that should be addressed in all trial protocols and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results.

Primary outcome reporting in adolescent depression clinical trials needs standardization.

BACKGROUND: Evidence-based health care is informed by results of randomized clinical trials (RCTs) and their syntheses in meta-analyses. When the trial outcomes measured are not clearly described in trial publications, knowledge synthesis, translation, and decision-making may be impeded. While heterogeneity in outcomes measured in adolescent major depressive disorder (MDD) RCTs has been described, the comprehensiveness of outcome reporting is unknown. This study aimed to assess the reporting of primary outcomes in RCTs evaluating treatments for adolescent MDD. METHODS: RCTs evaluating treatment interventions in adolescents with a diagnosis of MDD published between 2008 and 2017 specifying a single primary outcome were eligible for outcome reporting assessment. Outcome reporting assessment was done independently in duplicate using a comprehensive checklist of 58 reporting items. Primary outcome information provided in each RCT publication was scored as "fully reported", "partially reported", or "not reported" for each checklist item, as applicable. RESULTS: Eighteen of 42 identified articles were found to have a discernable single primary outcome and were included for outcome reporting assessment. Most trials (72%) did not fully report on over half of the 58 checklist items. Items describing masking of outcome assessors, timing and frequency of outcome assessment, and outcome analyses were fully reported in over 70% of trials. Items less frequently reported included outcome measurement instrument properties (ranging from 6 to 17%), justification of timing and frequency of outcome assessment (6%), and justification of criteria used for clinically significant differences (17%). The overall comprehensiveness of reporting appeared stable over time. CONCLUSIONS: Heterogeneous reporting exists in published adolescent MDD RCTs, with frequent omissions of key details about their primary outcomes. These omissions may impair interpretability, replicability, and synthesis of RCTs that inform clinical guidelines and decision-making in this field. Consensus on the minimal criteria for outcome reporting in adolescent MDD RCTs is needed.

Core outcome set for children with neurological impairment and tube feeding.

AIM: To develop a core outcome set (COS) for evaluating gastrostomy/gastrojejunostomy tube impact in children with neurological impairment. METHOD: Healthcare providers/researchers and caregivers rated the importance of candidate outcomes on a 5-point Likert scale. Outcomes rated 'somewhat important' or 'very important' by most (≥85%) respondents were voted on during a consensus meeting. Outcomes that reached consensus for inclusion were ratified and assigned to Outcome Measures in Rheumatology filter core areas. The COS was validated in a separate group of caregivers. RESULTS: Twelve outcomes were selected from 120 candidate outcomes to form the COS. These included five 'Life Impact' outcomes, three 'Pathophysiological Manifestations' outcomes, two 'Resource Use' outcomes, one 'Growth and Development' outcome, and one 'Death' outcome. INTERPRETATION: We developed an evidence-informed and consensus-based COS for use in studies of gastrostomy/gastrojejunostomy tube feeding in children with neurological impairment. Implementation of this COS will help reduce heterogeneity between studies and facilitate evidence-based decision-making. WHAT THE PAPER ADDS: Caregivers, healthcare providers, and researchers ranked the importance of 120 outcomes. Twelve core outcomes were identified as essential to measure in future clinical research studies.

CONJUNTO BÁSICO DE RESULTADOS PARA NIÑOS CON DETERIORO NEUROLÓGICO Y SONDA DE ALIMENTACIÓN: OBJETIVO: Desarrollar un conjunto básico de resultados (COS) para evaluar el impacto de la sonda de gastrostomía/gastro-yeyunostomía en niños con discapacidad neurológica. MÉTODO: Los proveedores/investigadores y cuidadores de salud calificaron la importancia de los resultados de los candidatos en una escala Likert de 5 puntos. Los resultados fueron calificados como "algo importantes" o "muy importantes" por la mayoría de los encuestados (85%) quienes votaron durante una reunión de consenso. Los resultados que llegaron a un consenso para la inclusión fueron ratificados y asignados a las medidas de resultado en las áreas centrales del filtro de reumatología. El COS fue validado en un grupo separado de cuidadores. RESULTADOS: Doce resultados fueron seleccionados de 120 candidatos para formar el COS. Estos incluyeron cinco resultados de "Impacto en la vida", tres resultados de "Manifestaciones patológicas", dos resultados de "uso de recursos", un resultado de "Crecimiento y desarrollo" y un resultado de "Muerte". INTERPRETACIÓN: Desarrollamos un COS basado en evidencia y basado en el consenso para su uso en estudios de sonda de alimentación por gastrostomía/gastro yeyunostomía en niños con discapacidad neurológica. La implementación de este COS ayudará a reducir la heterogeneidad entre los estudios y facilitará la toma de decisiones basadas en la evidencia.

ITENS PRINCIPAIS PARA CRIANÇAS COM DEFICIÊNCIA NEUROLÓGICA E TUBO DE ALIMENTAÇÃO: OBJETIVO: Desenvolver um conjunto de itens principais (CIP) para avaliar o impacto do tubo de gastrostomia/gastrojejunostomia em crianças com deficiência neurológica. MÉTODO: Pesquisadores, profissionais da saúde, e cuidadores pontuaram a importância dos desfechos candidatos em uma escala Likert de 5 pontos. Os desfechos pontuados como "algo importante"ou "muito importante" pela maioria '(≥85%) dos respondentes foram votados durante um encontro para consenso. Os desfechos que obtiveram consenso foram ratificados e incluídos no filtro de itens principais das Medidas de Resultados em Reumatologia. O CIP foi validado em um grupo separado de cuidadores. RESULTADOS: Doze resultados foram selecionados a partir de 120 resultados candidatos para formar o CIP. Estes incluíram cinco resultados de "Impacto na vida", três de Manifestações Patofisiológicas, um de "Crescimento e Desenvolvimento", e um sobre "Morte". INTERPRETAÇÃO: Desenvolvemos um CIP baseado em evidência e baseado em consenso para uso em estudos de alimentação por tubo de gastrostomia/gastrojejunostomia em crianças com deficiência neurológica. A implementation deste CIP irá ajudar a reduzir a heterogeneidade entre estudos e facilitar a tomada de decisões baseada em evidências.

Electronic Data Capture Versus Conventional Data Collection Methods in Clinical Pain Studies: Systematic Review and Meta-Analysis.

BACKGROUND: The most commonly used means to assess pain is by patient self-reported questionnaires. These questionnaires have traditionally been completed using paper-and-pencil, telephone, or in-person methods, which may limit the validity of the collected data. Electronic data capture methods represent a potential way to validly, reliably, and feasibly collect pain-related data from patients in both clinical and research settings. OBJECTIVE: The aim of this study was to conduct a systematic review and meta-analysis to compare electronic and conventional pain-related data collection methods with respect to pain score equivalence, data completeness, ease of use, efficiency, and acceptability between methods. METHODS: We searched the Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica Database (EMBASE), and Cochrane Central Register of Controlled Trials (CENTRAL) from database inception until November 2019. We included all peer-reviewed studies that compared electronic (any modality) and conventional (paper-, telephone-, or in-person-based) data capture methods for patient-reported pain data on one of the following outcomes: pain score equivalence, data completeness, ease of use, efficiency, and acceptability. We used random effects models to combine score equivalence data across studies that reported correlations or measures of agreement between electronic and conventional pain assessment methods. RESULTS: A total of 53 unique studies were included in this systematic review, of which 21 were included in the meta-analysis. Overall, the pain scores reported electronically were congruent with those reported using conventional modalities, with the majority of studies (36/44, 82%) that reported on pain scores demonstrating this relationship. The weighted summary correlation coefficient of pain score equivalence from our meta-analysis was 0.92 (95% CI 0.88-0.95). Studies on data completeness, patient- or provider-reported ease of use, and efficiency generally indicated that electronic data capture methods were equivalent or superior to conventional methods. Most (19/23, 83%) studies that directly surveyed patients reported that the electronic format was the preferred data collection method. CONCLUSIONS: Electronic pain-related data capture methods are comparable with conventional methods in terms of score equivalence, data completeness, ease, efficiency, and acceptability and, if the appropriate psychometric evaluations are in place, are a feasible means to collect pain data in clinical and research settings.

Muscle-specific deletion of SOCS3 does not reduce the anabolic response to leucine in a mouse model of acute inflammation.

Excessive inflammation reduces skeletal muscle protein synthesis leading to wasting and weakness. The janus kinase/signal transducers and activators of transcription-3 (JAK/STAT3) pathway is important for the regulation of inflammatory signaling. As such, suppressor of cytokine signaling-3 (SOCS3), the negative regulator of JAK/STAT signaling, is thought to be important in the control of muscle homeostasis. We hypothesized that muscle-specific deletion of SOCS3 would impair the anabolic response to leucine during an inflammatory insult. Twelve week old (n=8 per group) SOCS3 muscle-specific knockout mice (SOCS3-MKO) and littermate controls (WT) were injected with lipopolysaccharide (LPS, 1mg/kg) or saline and were studied during fasted conditions or after receiving 0.5g/kg leucine 3h after the injection of LPS. Markers of inflammation, anabolic signaling, and protein synthesis were measured 4h after LPS injection. LPS injection robustly increased mRNA expression of inflammatory molecules (Socs3, Socs1, Il-6, Ccl2, Tnfα and Cd68). In muscles from SOCS3-MKO mice, the Socs3 mRNA response to LPS was significantly blunted (∼6-fold) while STAT3 Tyr705 phosphorylation was exacerbated (18-fold). Leucine administration increased protein synthesis in both WT (∼1.6-fold) and SOCS3-MKO mice (∼1.5-fold) compared to basal levels. LPS administration blunted this effect, but there were no differences between WT and SOCS3-MKO mice. Muscle-specific SOCS3 deletion did not alter the response of AKT, mTOR, S6 or 4EBP1 under any treatment conditions. Therefore, SOCS3 does not appear to mediate the early inflammatory or leucine-induced changes in protein synthesis in skeletal muscle.

Wavelength selective mode division multiplexing on a silicon chip.

Multiplexing of optical modes in waveguides is demonstrated using coupled vertical gratings. The device utilizes sinusoidally corrugated waveguides of different widths with a period designed to multiplex information at 1.55 µm. The design, fabrication and characterization of devices is performed. Multiplexing of modes is demonstrated in optical structures which support 3 and 5 quasi-TE modes. The design utilizes counter-propagating modes in periodic structures, thus enabling the device to combine its mode division multiplexing capabilities with wavelength division multiplexing functionalities to further augment the multiplexing capacity of the device.

Integrative analysis reveals associations between oral microbiota dysbiosis and host genetic and epigenetic aberrations in oral cavity squamous cell carcinoma.

Dysbiosis of the human oral microbiota has been reported to be associated with oral cavity squamous cell carcinoma (OSCC) while the host-microbiota interactions with respect to the potential impact of pathogenic bacteria on host genomic and epigenomic abnormalities remain poorly studied. In this study, the mucosal bacterial community, host genome-wide transcriptome and DNA CpG methylation were simultaneously profiled in tumors and their adjacent normal tissues of OSCC patients. Significant enrichment in the relative abundance of seven bacteria species (Fusobacterium nucleatum, Treponema medium, Peptostreptococcus stomatis, Gemella morbillorum, Catonella morbi, Peptoanaerobacter yurli and Peptococcus simiae) were observed in OSCC tumor microenvironment. These tumor-enriched bacteria formed 254 positive correlations with 206 up-regulated host genes, mainly involving signaling pathways related to cell adhesion, migration and proliferation. Integrative analysis of bacteria-transcriptome and bacteria-methylation correlations identified at least 20 dysregulated host genes with inverted CpG methylation in their promoter regions associated with enrichment of bacterial pathogens, implying a potential of pathogenic bacteria to regulate gene expression, in part, through epigenetic alterations. An in vitro model further confirmed that Fusobacterium nucleatum might contribute to cellular invasion via crosstalk with E-cadherin/ß-catenin signaling, TNFα/NF-κB pathway and extracellular matrix remodeling by up-regulating SNAI2 gene, a key transcription factor of epithelial-mesenchymal transition (EMT). Our work using multi-omics approaches explored complex host-microbiota interactions and provided important insights into genetic and functional basis in OSCC tumorigenesis, which may serve as a precursor for hypothesis-driven study to better understand the causational relationship of pathogenic bacteria in this deadly cancer.

Role of surgical embolectomy in the management of acute massive and submassive pulmonary embolism in the setting of a small island developing state.

Acute pulmonary embolism (PE) remains a life-threatening condition despite advances in diagnostic and therapeutic modalities. Treatment modalities include systemic thrombolysis, catheter-based therapies and surgical embolectomy. This case report describes the first recorded surgical embolectomy for acute PE in Barbados, a small island developing state.

Case report: repair of eventration of the diaphragm in an octogenarian.

Eventration of the diaphragm is a cephalad displacement of the diaphragm because of congenital or acquired causes. The diaphragm maintains its anatomical continuity and normal attachments. It may be partial or complete and unilateral or bilateral. Most adult presentations are asymptomatic, but patients may present with respiratory, gastrointestinal, or cardiac symptoms. Surgical repair is indicated in the symptomatic patient with the most common being diaphragmatic plication. We present surgical repair of a symptomatic left diaphragmatic eventration in an octogenarian.

Neurodevelopmental outcome descriptions in cohorts of extremely preterm children.

BACKGROUND AND OBJECTIVES: Caregivers and clinicians of extremely preterm infants (born before 26 weeks' gestation) depend on long-term follow-up research to inform clinical decision-making. The completeness of outcome reporting in this area is unknown. The objective of this study was to evaluate the reporting of outcome definitions, selection, measurement and analysis in existing cohort studies that report on neurodevelopmental outcomes of children born extremely preterm. METHODS: We evaluated the completeness of reporting of 'cognitive function' and 'cerebral palsy' in prospective cohort studies summarised in a meta-analysis that assessed the effect of preterm birth on school-age neurodevelopment. Outcome reporting was evaluated using a checklist of 55 items addressing outcome selection, definition, measurement, analysis, presentation and interpretation. Reporting frequencies were calculated to identify strengths and deficiencies in outcome descriptions. RESULTS: All 14 included studies reported 'cognitive function' as an outcome; nine reported both 'cognitive function' and 'cerebral palsy' as outcomes. Studies reported between 26% and 46% of the 55 outcome reporting items assessed; results were similar for 'cognitive function' and 'cerebral palsy' (on average 34% and 33% of items reported, respectively). Key methodological concepts often omitted included the reporting of masking of outcome assessors, methods used to handle missing data and stakeholder involvement in outcome selection. CONCLUSIONS: The reporting of neurodevelopmental outcomes in cohort studies of infants born extremely preterm is variable and often incomplete. This may affect stakeholders' interpretation of study results, impair knowledge synthesis efforts and limit evidence-based decision-making for this population.

Guidance for reporting outcomes in clinical trials: scoping review protocol.

INTRODUCTION: Patients, families and clinicians rely on published research to help inform treatment decisions. Without complete reporting of the outcomes studied, evidence-based clinical and policy decisions are limited and researchers cannot synthesise, replicate or build on existing research findings. To facilitate harmonised reporting of outcomes in published trial protocols and reports, the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT) is under development. As one of the initial steps in the development of InsPECT, a scoping review will identify and synthesise existing guidance on the reporting of trial outcomes. METHODS AND ANALYSIS: We will apply methods based on the Joanna Briggs Institute scoping review methods manual. Documents that provide explicit guidance on trial outcome reporting will be searched for using: (1) an electronic bibliographic database search; (2) a grey literature search; and (3) solicitation of colleagues for guidance documents using a snowballing approach. Reference list screening will be performed for included documents. Search results will be divided between two trained reviewers who will complete title and abstract screening, full-text screening and data charting. Captured trial outcome reporting guidance will be compared with candidate InsPECT items to support, refute or refine InsPECT content and to assess the need for the development of additional items. Data analysis will explore common features of guidance and use quantitative measures (eg, frequencies) to characterise guidance and its sources. ETHICS AND DISSEMINATION: A paper describing the review findings will be published in a peer-reviewed journal. The results will be used to inform the InsPECT development process, helping to ensure that InsPECT provides an evidence-based tool for standardising trial outcome reporting.

Improving outcome reporting in clinical trial reports and protocols: study protocol for the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT).

BACKGROUND: Inadequate and poor quality outcome reporting in clinical trials is a well-documented problem that impedes the ability of researchers to evaluate, replicate, synthesize, and build upon study findings and impacts evidence-based decision-making by patients, clinicians, and policy-makers. To facilitate harmonized and transparent reporting of outcomes in trial protocols and published reports, the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT) is being developed. The final product will provide unique InsPECT extensions to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines. METHODS: The InsPECT SPIRIT and CONSORT extensions will be developed in accordance with the methodological framework created by the EQUATOR (Enhancing the Quality and Transparency of Health Research Quality) Network for reporting guideline development. Development will consist of (1) the creation of an initial list of candidate outcome reporting items synthesized from expert consultations and a scoping review of existing guidance for reporting outcomes in trial protocols and reports; (2) a three-round international Delphi study to identify additional candidate items and assess candidate item importance on a 9-point Likert scale, completed by stakeholders such as trial report and protocol authors, systematic review authors, biostatisticians and epidemiologists, reporting guideline developers, clinicians, journal editors, and research ethics board representatives; and (3) an in-person expert consensus meeting to finalize the set of essential outcome reporting items for trial protocols and reports, respectively. The consensus meeting discussions will be independently facilitated and informed by the empirical evidence identified in the primary literature and through the opinions (aggregate rankings and comments) collected via the Delphi study. An integrated knowledge translation approach will be used throughout InsPECT development to facilitate implementation and dissemination, in addition to standard post-development activities. DISCUSSION: InsPECT will provide evidence-informed and consensus-based standards focused on outcome reporting in clinical trials that can be applied across diverse disease areas, study populations, and outcomes. InsPECT will support the standardization of trial outcome reporting, which will maximize trial usability, reduce bias, foster trial replication, improve trial design and execution, and ultimately reduce research waste and help improve patient outcomes.

Learning best-practices in journalology: course description and attendee insights into the inaugural EQUATOR Canada Publication School.

BACKGROUND AND PURPOSE: Dissemination of research results is a key component of the research continuum and is commonly achieved through publication in peer-reviewed academic journals. However, issues of poor quality reporting in the research literature are well documented. A lack of formal training in journalology (i.e., publication science) may contribute to this problem. To help address this gap in training, the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Canada Publication School was developed and facilitated by internationally-renowned faculty to train researchers and clinicians in reporting and publication best practices. This article describes the structure of the inaugural course and provides an overview of attendee evaluations and perspectives. KEY HIGHLIGHTS: Attendees perceived the content of this two-day intensive course as highly informative. They noted that the course helped them learn skills that were relevant to academic publishing (e.g., using reporting guidelines in all phases of the research process; using scholarly metrics beyond the journal impact factor; open-access publication models; and engaging patients in the research process). The course provided an opportunity for researchers to share their challenges faced during the publication process and to learn skills for improving reproducibility, completeness, transparency, and dissemination of research results. There was some suggestion that this type of course should be offered and integrated into formal training and course curricula. IMPLICATIONS: In light of the importance of academic publishing in the scientific process, there is a need to train and prepare researchers with skills in Journalology. The EQUATOR Canada Publication School provides an example of a successful program that addressed the needs of researchers across career trajectories and provided them with resources to be successful in the publication process. This approach can be used, modified, and/or adapted by curriculum developers interested in designing similar programs, and could be incorporated into academic and clinical research training programs.

Pushing the limits of CMOS optical parametric amplifiers with USRN:Si7N3 above the two-photon absorption edge.

CMOS platforms operating at the telecommunications wavelength either reside within the highly dissipative two-photon regime in silicon-based optical devices, or possess small nonlinearities. Bandgap engineering of non-stoichiometric silicon nitride using state-of-the-art fabrication techniques has led to our development of USRN (ultra-silicon-rich nitride) in the form of Si7N3, that possesses a high Kerr nonlinearity (2.8 × 10-13 cm2 W-1), an order of magnitude larger than that in stoichiometric silicon nitride. Here we experimentally demonstrate high-gain optical parametric amplification using USRN, which is compositionally tailored such that the 1,550 nm wavelength resides above the two-photon absorption edge, while still possessing large nonlinearities. Optical parametric gain of 42.5 dB, as well as cascaded four-wave mixing with gain down to the third idler is observed and attributed to the high photon efficiency achieved through operating above the two-photon absorption edge, representing one of the largest optical parametric gains to date on a CMOS platform.

Management of Chronic Total Coronary Occlusion in Stable Ischemic Heart Disease by Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting Versus Medical Therapy.

Coronary chronic total occlusions (CTOs) are found in approximately 20% of angiograms. We sought to assess the variation in the management of patients with CTOs and to compare the clinical outcomes of CTO lesions with those of non-CTO lesions. We conducted a population-based cohort study and included all patients with stable angina who underwent cardiac catheterization from October 1, 2012, to June 30, 2013, in Ontario, Canada. The primary outcome was a composite of mortality and hospitalization for myocardial infarction. A total of 7,864 patients were included, of whom 2,279 (29%) had a CTO. There were substantial differences in revascularization rates for patients with CTOs across hospitals in Ontario (44.9% to 94.1%). Revascularization was associated with improved outcomes in the overall cohort. Although the advantage of coronary artery bypass grafting over medical therapy was consistent in both patients with CTOs and patients without CTOs, the benefit of percutaneous coronary intervention (PCI) was limited to patients without CTOs (hazard ratio 0.56, 95% confidence interval 0.40- to 0.78), with no difference in patients with CTOs. The CTO lesion, however, was revascularized in few of the PCI cases (41.1%), with PCI limited to the non-CTO lesion in most patients.

Transcutaneous carbon dioxide measurement after craniotomy in spontaneously breathing patients.

OBJECTIVE: The purpose of this study was to determine the incidence of postoperative hypercarbia in patients undergoing intracranial neurosurgery. Postoperative hypercarbia is a well-recognized cause of postoperative morbidity. METHODS: Sixty-four patients undergoing craniotomy were monitored in the first 36 postoperative hours using transcutaneous CO2 monitoring. We collected and analyzed demographic data, complete medical histories and examinations, and details of surgery, anesthesia, and postoperative progress. The accuracy of the transcutaneous CO2 monitoring was evaluated by comparison with arterial blood gas CO2. INSTRUMENTATION: The "TINA" TCM3 Transcutaneous CO2 Monitor (Radiometer, Copenhagen, Denmark) was used. RESULTS: Thirty-nine patients (61%) developed no hypercarbia. Nineteen patients (30%) developed mild to moderate hypercarbia (46-59 mm Hg) and six patients (9%) developed severe hypercarbia (60 mm Hg or greater). Statistically significant differences were observed between the severely hypercarbic group and the other two groups combined, as follows: a higher incidence of preoperative and postoperative seizures, a lower average postoperative Glasgow Coma Scale score, a higher incidence of reintubation and ventilation, and a higher degree of intraoperative brain disturbance. Analysis of transcutaneous CO2 measurements and time-matched arterial blood gas CO2 measurements revealed an acceptable accuracy of the transcutaneous method. CONCLUSION: this study demonstrates that, in routine neurosurgical practice, a subgroup of patients are at risk of developing postoperative hypercarbia, which may be more common than is generally recognized and will not usually be detected by routine postoperative monitoring. Transcutaneous CO2 monitoring is a useful technique that may impact management decisions.

Central cholinergic control of cerebral blood flow in the baboon. Effect of cholinesterase inhibition with neostigmine on autoregulation and CO2 responsiveness.

Cerebral autoregulation and vastomotor responsiveness to carbon dioxide (CO2) were measured quantitatively by the use of the autoregulation index and chemical index, respectively, in normal baboons before and after intravertebral and intracarotid infusion of the anticholinesterase agent, neostigmine methylsufate (Prostigmin). Continuous measurements were made of cerebral blood flow (measured as bilateral internal jugular venous outflow), arterial and cerebral venous pO2 and pCO2, cerebral arteriovenous oxygen differences, and endotracheal CO2. The effect of intravertebral infusion of neostigmine (12.5 mug/kg body weight) was compared to intravertebral infusion of neostigmine (25 mug/kg body weight) for assessment of any specific action of the drug on a hypothetical cholinergic vasomotor center, presumed to be located in the territory of the vertebrobasilar supply. No significant or persistent changes in cerebral blood flow (CBF) and cerebral metabolic rate for oxygen (CMRO2) followed either intravertebral or intracarotid infusion of neostigmine. Cerebral vascular resistance (CVR) and cerebral perfusion pressure (CPP), however, decreased significantly after intravertebral infusion. Cerebral autoregulatory vasoconstriction during increases of CCP was significantly reduced following both intravertebral and intracarotid infusion. Cerebral autoregulatory vasodilatation was not altered as CPP was lowered. Cerebral vasodilatory reactivity to CO2 inhalation was significantly enhanced following intravertebral neostigime but not following intracarotid neostigmine. Cerebral vasoconstrictive response to hyperventilation was not influenced by neostigmine. These results support the view that central cholinergic cerebrovascular influences exist, and are vasodilatory in nature.

Transcatheter closure of patent ductus arteriosus using detachable spring coils.

OBJECTIVE: To report our experience with transcatheter PDA closure using detachable spring coils. METHODS: Suitable patients who presented between March 1996 to July 1997 were selected for coil occlusion of PDA after the diagnosis is confirmed on colour doppler echocardiography. Twenty-seven patients underwent an attempt at transcatheter closure of PDA with coils. Twenty-one were native ducts while 6 were residual ductal leaks following surgical ligation (4) and Rashkind umbrella occlusion (2). RESULTS: The patients' age ranged from 20 months to 39 years (median 5.5 years) and weighed from 10.5 kg to 49 kg (median 21 kg). The PDA diameter ranged from 1.3 mm to 5 mm (mean 2.4 mm). Twenty-four patients had coils successfully deployed (one coil in each patient) and all had PDA diameter of < or = 3.5 mm. Seventeen had complete occlusion on echocardiographic colour doppler assessment within 24 hrs. Follow-up colour doppler assessment showed complete occlusion in all 24 patients by 6 months. There were no cases of coil embolisation or any other complications. Unsuccessful coil deployment was encountered in 3 patients with PDA diameter of > or = 4 mm. CONCLUSION: The detachable coil system allows for complete control over coil release and therefore deployment is precise and complications are minimised. Transcatheter closure of PDA with the detachable coil is a safe and effective method especially for small ducts (< or = 3.5 mm).