Public awareness of cardiopulmonary resuscitation and cardiac arrest in association with Christian Eriksen.

OBJECTIVES: During the Union of European Football Association EURO 2020 Football Championship, Danish football player Christian Eriksen experienced a cardiac arrest on the field of play. With prompt intervention and cardiopulmonary resuscitation (CPR), Erikson had a positive outcome and survived the arrest. Our goal is to determine the extent to which this event informed the general population about cardiac arrests and CPR. STUDY DESIGN: This was a cross-sectional internet analysis. METHODS: First, Google Trends was used to identify the search interest of topics "Cardiopulmonary resuscitation," "Myocardial infarction," and disease "Cardiac arrest" worldwide from May 29, 2021, to June 19, 2021. Second, we downloaded Twitter data via Sprout Social using the keywords "CPR" and "cardiac arrest," which are presented as the absolute number of tweets. An ARIMA model was used to forecast expected search volumes. RESULTS: The following week, there was an increase of 91.72% (95% confidence interval [CI] 89.01-94.93) for "Cardiac arrest" above expected values, an 80.67% (95% CI 75.84-85.5) increase for "Cardiopulmonary resuscitation," and a 65.50% (95% CI 62.98-68.02) increase for "Myocardial infarction." Within Twitter, there was a peak increase in daily tweets using "CPR" by 184,706 (95% CI 181,933-187,479) beyond expected values and a peak increase in the daily tweets using "cardiac arrest" by 73,126 (95% CI 72,499-73,752). CONCLUSION: Although all cardiac arrests are undesirable, public knowledge of the positive effects of CPR could contribute to a means of promoting and increasing the desire for CPR awareness as well as its application.

Risk of Bias and Quality of Reporting in Colon and Rectal Cancer Systematic Reviews Cited by National Comprehensive Cancer Network Guidelines.

INTRODUCTION: Given the changing landscape of colorectal cancer, systematic reviews are likely to play a key role in advancing the understanding of prevention, diagnosis, and treatment. METHODS: We conducted a cross-sectional investigation of the risk of bias and reporting quality of systematic reviews referenced by colon and rectal cancer National Comprehensive Cancer Network (NCCN) guidelines. We used two widely accepted tools: Risk of Bias in Systematic reviews (ROBIS) and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). RESULTS: Using ROBIS, only 3 (4.8%) systematic reviews were judged with low risk of bias, 35 (55.6%) systematic reviews were judged with unclear risk of bias, and 25 (39.7%) systematic reviews were judged with high risk of bias. Across all systematic reviews, the individual bias domains at the highest risk of bias were domains 1 (protocol and eligibility criteria) and 2 (methods to identify and select studies). Across all studies, the median adherence to PRISMA was 74.1% (IQR 69.2-80.0%), corresponding to approximately 20 of 27 items. CONCLUSIONS: Systematic reviews cited in NCCN guidelines for colon and rectal cancer are frequently at unclear or high risk of bias and do not report key systematic review items that are important for the critical appraisal of results.

A comparison of matched interim analysis publications and final analysis publications in oncology clinical trials.

Background: Progression-free survival is an increasingly popular surrogate end point for overall survival. The strength of correlation between the two end points varies, raising questions about the correlation between results of interim analyses that report mature progression-free survival data with the subsequent final publication that report overall survival. Methods: We searched PubMed from 2005 to 2015 for randomized controlled trials that measured both progression-free survival and overall survival. We matched interim publications that reported mature progression-free survival data with their final analyses that reported overall survival. We included 25 matched pairs and 8 unmatched interim analyses whose final analyses are not published. Our primary objectives are to compare interim publications with matched final publications in terms of journal prominence and Altmetric score and to compare progression-free survival and overall survival effect sizes. Results: All interim analyses (n = 33) were prespecified and there was a statistically significant progression-free survival benefit in 31 (93.9%). Only eight matched final analyses had statistically significant overall survival data. Interim analyses were more often published in top-5 general medicine journals (P < 0.01) but not in top-5 oncology journals (P = 0.26). Altmetric scores were higher in interim analyses (P < 0.01). Progression-free survival effect sizes from interim analyses were a median of 31% larger than overall survival effect sizes from final analyses. Conclusion: Interim analyses with progression-free survival data may generate hype in oncology, as evidenced by journal impact factors and Altmetric scores. The cause of this hype may be due, in part, to large progression-free survival effect sizes. Regardless, in trials that investigate progression-free and overall survival, publishing interim analyses with mature progression-free survival data apart from the final analyses with mature overall survival should be cautioned.

An observational analysis of discontinuation and non-publication of osteoarthritis trials.

OBJECTIVE: Discontinuation and nonpublication are causes for concern in highly funded research areas of prevalent medical conditions. The aim of our study is to evaluate the rate of discontinuation and nonpublication in osteoarthritis randomized controlled clinical trials. DESIGN: We used the ClinicalTrials.gov advanced search using the keyword "osteoarthritis" for phase 3 or phase 4 clinical trials in adults. Two investigators then independently screened the search results by registered title, condition, study design, and completion date. We then performed a systematic search to determine the publication status of the study. RESULTS: Our final analysis included 273 studies. Our analysis of these studies included 243 (89%) completed and 30 (11%) discontinued trials. A total of 121,307 (92%) and 10,368 (8%) patients participated in completed and discontinued trials, respectively. Following our searches of PubMed, Embase, and Google Scholar, we identified 67 of the 243 (27.6%) studies as completed but having not reached publication in manuscript form. CONCLUSIONS: If discontinuation and non-publication rates in osteoarthritis trials continue to be sub-optimal, already scarce research resources will continue to be wasted. One possible explanation for the witnessed nonpublication that warrants further investigation is the issue of publication bias or selective reporting bias, two known problems that decrease research productivity and ethics.

A systematic review of outcomes in postoperative pain studies in paediatric and adolescent patients: towards development of a core outcome set.

Systematic reviews of postoperative pain in children have called into question the consistency of outcomes measured by clinical triallists as well as the measurement instruments used for assessment. Core outcome set methodology may be a solution to improve standardisation. This study provides an evidence-based foundation for the development of a core outcome set for paediatric postoperative pain studies. We searched ClinicalTrials.gov to identify relevant postoperative pain studies in children. The search yielded 300 registered trials. The following data were then extracted from each of the trials: phase of trial; study type; study design; sample size; all outcomes; whether the outcome was listed as primary, secondary, or tertiary; the measurement instrument for each reported outcome; the specific metric for each outcome; and the type of clinical procedure. Following screening, 134 studies were included in our study. Pain measurement was the most commonly reported outcome (n = 123), followed by total postoperative analgesic dosage (n = 83) and side-effects (n = 25). Temporal trends indicated that pain assessment and unexpected events increased in use between 2000 and 2016, whereas postoperative analgesia measurement decreased. We found a lack of standardisation among outcomes and measurement instruments in paediatric postoperative pain studies. Development of a core outcome set may improve the quality of future trials and allow for more accurate study-to-study comparisons.

Statistical controversies in clinical research: publication bias evaluations are not routinely conducted in clinical oncology systematic reviews.

Background: Publication bias is an over-representation of statistically significant results in the published literature and may exaggerate summary effect estimates in oncology systematic reviews. Omitting non-significant results in systematic reviews may therefore affect clinical decision-making. We investigate ways that systematic reviewers attempted to limit publication bias during the search process as well as the statistical methods used to evaluate it. For a subset of reviews not reporting publication bias evaluations, we carried out our own assessments for publication bias to determine its likelihood among these reviews. Design: We examined systematic reviews from the top five highest impact factor oncology journals published between 2007 and 2015. Systematic reviews were screened for eligibility and qualifying reviews (n = 182) were coded for relevant publication bias study characteristics by two authors. A re-analysis of reviews not initially evaluating for publication bias was carried out using Egger's regression, trim-and-fill, and selection models. Results: Of the 182 systematic reviews, roughly half carried out a hand search to locate additional studies. Conference abstracts were the most commonly reported form of gray literature, followed by clinical trials registries. Fifty-one reviews reported publication bias evaluations. The most common method was the funnel plot (80%, 41/51) followed by Egger's regression (59%, 30/51) and Begg's test (43%, 22/51). Our publication bias evaluations on non-reporting reviews suggest that the degree of publication bias depends on the method employed. Conclusion: Our study shows publication bias assessments are not frequently used in oncology systematic reviews. Furthermore, evidence of publication bias was found in a subset of non-reporting reviews. Systematic reviewers in oncology are encouraged to conduct such analyses when appropriate and to employ more robust methods for both mitigating and evaluating publication bias.

Heterogeneity of studies in anesthesiology systematic reviews: a meta-epidemiological review and proposal for evidence mapping.

Heterogeneity among the primary studies included in a systematic review (SR) is one of the most challenging considerations for systematic reviewers. Current practices in anaesthesiology SRs have not been evaluated, but traditional methods may not provide sufficient information to evaluate the true nature of these differences. We address these issues by examining the practices for evaluating heterogeneity in anesthesiology reviews. Also, we propose a mapping method for presenting heterogeneous aspects of the primary studies in SRs.We evaluated heterogeneity practices reported in SRs published in highly ranked anesthesiology journals and Cochrane reviews. Elements extracted from the SRs included heterogeneity tests, models used, analyses conducted, plots used, and I2 values. Additionally, we selected a SR to develop an evidence map in order to display clinical heterogeneity.Our statistical analysis showed 150/207 SRs reporting a test for statistical heterogeneity. Plots were used in 138 reviews to display heterogeneity. Subgroup analyses were the most commonly reported analysis (54%). Meta-regression and sensitivity analyses were used sparingly (25%; 23% respectively). A random effects model was most commonly reported (33%). Heterogeneity statistics across meta-analyses suggested that, in our sample, the majority (55%) did not present sufficient heterogeneity to be of great concern. Cochrane reviews (n=58) were also analysed. Plots were used in 88% of Cochrane reviews. Subgroup analysis was used in 59% Cochrane reviews, while sensitivity analysis was used in 62%.Many reviews did not provide sufficient detail regarding heterogeneity. We are calling for improvement to reporting practices.

Evaluation of reproducible and transparent research practices in pulmonology.

BACKGROUND: Study reproducibility is valuable for validating or refuting results. Provision of reproducibility indicators, such as materials, protocols, and raw data in a study improve its potential for reproduction. Efforts to reproduce noteworthy studies in the biomedical sciences have resulted in an overwhelming majority of them being found to be unreplicable, causing concern for the integrity of research in other fields, including medical specialties. Here, we analyzed the reproducibility of studies in the field of pulmonology. METHODS: 500 pulmonology articles were randomly selected from an initial PubMed search for data extraction. Two authors scoured these articles for reproducibility indicators including materials, protocols, raw data, analysis scripts, inclusion in systematic reviews, and citations by replication studies as well as other factors of research transparency including open accessibility, funding source and competing interest disclosures, and study preregistration. FINDINGS: Few publications included statements regarding materials (10%), protocols (1%), data (15%), and analysis script (0%) availability. Less than 10% indicated preregistration. More than half of the publications analyzed failed to provide a funding statement. Conversely, 63% of the publications were open access and 73% included a conflict of interest statement. INTERPRETATION: Overall, our study indicates pulmonology research is currently lacking in efforts to increase replicability. Future studies should focus on providing sufficient information regarding materials, protocols, raw data, and analysis scripts, among other indicators, for the sake of clinical decisions that depend on replicable or refutable results from the primary literature.

The evolution of white matter microstructural changes after mild traumatic brain injury: A longitudinal DTI and NODDI study.

Neuroimaging biomarkers that can detect white matter (WM) pathology after mild traumatic brain injury (mTBI) and predict long-term outcome are needed to improve care and develop therapies. We used diffusion tensor imaging (DTI) and neurite orientation dispersion and density imaging (NODDI) to investigate WM microstructure cross-sectionally and longitudinally after mTBI and correlate these with neuropsychological performance. Cross-sectionally, early decreases of fractional anisotropy and increases of mean diffusivity corresponded to WM regions with elevated free water fraction on NODDI. This elevated free water was more extensive in the patient subgroup reporting more early postconcussive symptoms. The longer-term longitudinal WM changes consisted of declining neurite density on NODDI, suggesting axonal degeneration from diffuse axonal injury for which NODDI is more sensitive than DTI. Therefore, NODDI is a more sensitive and specific biomarker than DTI for WM microstructural changes due to mTBI that merits further study for mTBI diagnosis, prognosis, and treatment monitoring.

Evaluation of spin in oncology clinical trials.

PURPOSE: Spin, the misrepresentation of research findings, in clinical trial abstract has been shown to influence how oncologist rate a drug's efficacy. MATERIALS AND METHODS: We searched PubMed for clinical trials published in ten key journals in 2017. Our primary objectives were to assess the frequency and manifestations of spin in the abstracts of those clinical trials that measured both overall survival and at least one surrogate efficacy endpoints. RESULTS: 124 trials were included for analysis. We found evidence of spin in 46 of 124 (37.1%, 95% CI 29.1%-45.9%) trial abstracts. Spin in the abstract results was most often due to authors emphasizing a statistically significant subgroup analysis (n = 6). Spin in the abstract conclusions was most often due to authors relying on a statistically significant surrogate endpoint to highlight the bioefficacy of the intervention (n = 17). CONCLUSION: Spin is prevalent in the abstracts of oncology clinical trials that measure OS and a surrogate endpoint. The conclusion sections of abstracts were most prone to contain spin. When OS was the primary endpoint, spin was primarily used to distract from the nonsignificant OS data. To mitigate unintentional hype for cancer therapies, we recommend authors structure their conclusions around patient-important outcomes.

Evaluation of spin within abstracts in obesity randomized clinical trials: A cross-sectional review.

This is a cross-sectional analysis of spin in randomized controlled trial (RCT) abstracts published in top-ranked obesity and general medicine journals. The top seven obesity and four general medicine journals were searched from 1 January 2016 to 31 December 2017. To be included in this study, a trial must be an RCT with non-significant primary endpoint (P > 0.05), exclusively randomize subjects with overweight or obesity or have a primary endpoint of weight loss. These studies were analysed by two reviewers for spin in the abstract. The primary endpoint of our investigation was the frequency and type of spin. The secondary endpoint was to assess whether funding source was associated with the presence of spin. Our PubMed search yielded 1143 articles. Primary screening excluded 992 articles, and full-text evaluation excluded an additional 106. Overall, 45 articles were included. Spin was identified in 21 of the 45 (46.7%) abstracts analysed. Evidence of spin was found in 17 (37.8%) abstract result sections and 11 (24.4%) abstract conclusion sections. Of the 39 RCTs reporting a clinical trial registry, 6 (15.4%) had evidence of selective reporting bias. Our study found that obesity medicine RCTs from top-ranked journals with non-significant primary endpoints published in 2016 and 2017 frequently have spin in their abstracts. Abstracts with evidence of spin may influence a reader's perception of new drugs or procedures. These results warrant a careful review of future RCTs, but may not be generalizable to RCTs published in lower-ranked journals.

Interventional Radiology Clinical Practice Guideline Recommendations for Neurovascular Disorders Are Not Based on High-Quality Systematic Reviews.

BACKGROUND: In recent years, clinical practice guidelines have been criticized for biased interpretations of research evidence, and interventional radiology is no exception. PURPOSE: Our aim was to evaluate the methodologic quality and transparency of reporting in systematic reviews used as evidence in interventional radiology clinical practice guidelines for neurovascular disorders from the Society of Interventional Radiology. DATA SOURCES: Our sources were 9 neurovascular disorder clinical practice guidelines from the Society of Interventional Radiology. STUDY SELECTION: We selected 65 systematic reviews and meta-analyses. DATA ANALYSIS: A Measurement Tool to Assess Systematic Reviews (AMSTAR) and Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) tools were used to assess the methodologic quality and reporting transparency of systematic reviews. Radial plots were created on the basis of average scores for PRISMA and AMSTAR items. DATA SYNTHESIS: On the basis of AMSTAR scores, 3 (4.62%) reviews were high-quality, 28 reviews (43.08%) were moderate-quality, and 34 reviews (52.31%) were low-quality, with an average quality score of 3.66 (34.32%; minimum, 0%; maximum, 81.82%). The average PRISMA score was 18.18 (69.41%). LIMITATIONS: We were unable to obtain previous versions for 8 reviews, 7 of which were from the Cochrane Database of Systematic Reviews. CONCLUSIONS: The methodologic quality of systematic reviews needs to be improved. Although reporting clarity was much better than the methodologic quality, it still has room for improvement. The methodologic quality and transparency of reporting did not vary much among clinical practice guidelines. This study can also be applied to other medical specialties to examine the quality of studies used as evidence in their own clinical practice guidelines.

Hematology journals do not sufficiently adhere to reporting guidelines: a systematic review.

Essentials Reporting guidelines and trial/review registration aim to limit bias in research. We systematically reviewed hematology journals to examine the use of these policies. Forty-eight percent of journals made no use of these policies. Improving the use of reporting guidelines will improve research for all stakeholders. SUMMARY: Background Reporting guidelines and trial/review registration policies have been instituted in order to minimize bias and improve research practices. Objective The objective of this study was to investigate the policies of hematology journals concerning reporting guideline adoption and trial/review registration. Methods We performed a web-based data abstraction from the Instructions for Authors of 67 hematology journals catalogued in the Expanded Science Citation Index of the 2014 Journal Citation Reports to identify whether each journal required, recommended or made no mention of the following reporting guidelines: EQUATOR, ICMJE, CONSORT, MOOSE, QUOROM, PRISMA, STARD, STROBE, ARRIVE and CARE. We also extracted whether journals required or recommended trial or systematic review registration. We e-mailed editors three times to determine which types of studies their journal accepts. Results Forty-eight per cent (32/67) of hematology journals do not adhere to any reporting guidelines. For responding journals, the QUOROM statement, MOOSE, CARE and PROSPERO were the least often mentioned, whereas the ICMJE guidelines, CONSORT statement and general trial registration were most often mentioned. Discussion Reporting guidelines are infrequently required or recommended by hematology journals. Furthermore, few require clinical trial or systematic review database registration. A higher rate of adherence to reporting guidelines can prevent bias from entering the literature. Participation from all stakeholders, including authors and journal editors, to improve reporting guideline and policy practices is required.

Selective outcome reporting in obesity clinical trials: a cross-sectional review.

Selective outcome reporting is a form of bias resulting from discrepancies between outcomes presented in a trial's registration and the published report. We investigate this selective bias in obesity clinical trials. A PubMed search was conducted to identify randomized controlled trials (RCTs) published in four obesity journals from 2013 to 2015. Primary, secondary and tertiary outcomes were recorded for each trial and compared to pre-specified outcomes in each trial's registration. Of the 392 identified articles, 142 were included in the final analysis; 22 (15%) RCTs demonstrated major outcome discrepancies between registration and publication: No primary outcomes were demoted to a secondary or tertiary outcome; 14 (36.84%) primary outcomes were omitted; 14 (36.84%) primary outcomes were added: 5 (13.16%) secondary outcomes were upgraded to primary outcomes; and timing of assessment for a primary outcome changed 5 (13.16%) times. Out of the 63 prospectively registered studies, 53 had no discrepancies. A total of 76 of the studies (29.80%) were unregistered or did not have an associated registration number. Our results suggest that selective outcome reporting may be a concern in obesity clinical trials. As selective outcome reporting may distort clinical findings and limit outcomes in systematic reviews, we encourage trialists and journal editors to work towards solutions to mitigate this issue.