Ipratropium/Salbutamol Comparator Versus Originator for Chronic Obstructive Pulmonary Disease Exacerbations : USA Observational Cohort Study Using the Clinformatics™ Health Claims Database

Acknowledgements The authors wish to thank Priyanka Raju Konduru of Observational and Pragmatic Research Institute Pte Ltd (OPRI) for assistance with data extraction. This study was sponsored and funded by Teva Branded Pharmaceutical Products, R&D, Inc. Lynanne McGuire, PhD, of MedVal Scientific Information Services, LLC (Princeton, NJ, USA) provided medical writing and editorial assistance. This manuscript was prepared according to the International Society for Medical Publication Professionals’ ‘Good Publication Practice for Communicating Company-Sponsored Medical Research: the GPP3 Guidelines.’ Funding to support medical writing assistance was provided to MedVal by Teva Branded Pharmaceutical Products R&D, Inc., Frazer, PA, USA. Teva provided a full review of the article and provided funding of the journal’s article processing charges. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.Peer reviewedPublisher PD

Real-life effectiveness and safety of the inhalation suspension budesonide comparator vs the originator product for the treatment of patients with asthma : a historical cohort study using a US health claims database

Peer reviewedPublisher PD

Comparison of adverse events associated with different spacers used with non-extrafine beclometasone dipropionate for asthma

The authors would like to extend their acknowledgement to Dr. Antony Hardjojo for proof-reading this manuscript. This study is funded by Chiesi Limited. All relevant data are within the paper and the supporting information files. The dataset supporting the conclusions of this article was derived from the UK Optimum Patient Care Research Database (www.opcrd.co.uk). We do not have permission to give public access to these databases; however, researchers may request access for their own purposes. Request for access to OCPRD can be made via the OCPRD website (https://opcrd.co.uk/our-database/data-requests/) or via the enquiries email [email protected] reviewedPublisher PD

Real-life effectiveness and safety of salbutamol Steri-Neb™ vs. Ventolin Nebules® for exacerbations in patients with COPD : Historical cohort study

This study was sponsored and funded by Teva Branded Pharmaceutical Products, R&D, Inc (Frazer, PA). The study was designed by academic investigators and by representatives of the sponsor, Teva Branded Pharmaceutical Products, R&D, Inc. Statistical analysis was completed by investigator VT. All authors contributed to the interpretation of data and writing or critically reviewing and revising the manuscript. All authors had access to the data and take complete responsibility for the integrity of the data and accuracy of the data analysis. The corresponding author had full access to all of the data and had final responsibility to submit for publication. This manuscript was prepared according to the International Society for Medical Publication Professionals’ Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3. Data Availability: All relevant data are within the paper, and unmatched data for all outcomes is provided in the Supporting Information files. The dataset supporting the conclusions of this article was derived from the Clinical Practice Research Datalink (www.cprd.com) and the UK Optimum Patient Care Research Database (www.opcrd.co.uk). The authors do not have permission to give public access to these databases; however, researchers may request access for their own purposes. The CPRD has broad National Research Ethics Service Committee (NRES) ethics approval for purely observational research using the primary care data and established data linkages. The OPCRD has ethical approval from the National Health Service (NHS) Research Authority to hold and process anonymized research data (Research Ethics Committee reference: 15/EM/0150). This study was approved by the Anonymised Data Ethics Protocols and Transparency (ADEPT) Committee—the independent scientific advisory committee for the OPCRD, commissioned by the Respiratory Effectiveness Group—and the Independent Scientific Advisory Committee (ISAC) for the CPRD. The study was designed, implemented, and registered in accordance with the criteria of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCEPP/SDPP/7645).Peer reviewedPublisher PD

Physiological predictors of peak inspiRatory flow using Observed lung function results (POROS) : evaluation at discharge among patients hospitalized for a COPD exacerbation

This study was supported by AstraZeneca. The abstract of this paper was presented at the American Thoracic Society International Conference 2017 as a poster presentation with interim findings.Peer reviewedPublisher PD

Adequacy of therapy for people with both COPD and heart failure in the UK : historical cohort study

Acknowledgments We thank Derek Skinner for his contributions to the data acquisition and handling and Carole Nicholls and Priyanka Raju Konduru for statistical support. Writing and editorial support was provided by Elizabeth V. Hillyer, DVM, supported by Novartis Pharma AG, Basel, Switzerland. Funding This work was supported by Novartis. Employees of the sponsor (listed as authors) participated in the study design, interpretation of the results, writing of the report, and the decision to submit the paper for publication.Peer reviewedPublisher PD

Does Changing Inhaler Device Impact Real-Life Asthma Outcomes? : Clinical and Economic Evaluation

This study was funded by Mundipharma Korea Limited (Seoul, Korea).Peer reviewedPostprin

The use of multiple respiratory inhalers requiring different inhalation techniques has an adverse effect on COPD outcomes

This study was funded by Teva Pharmaceutical Industries Ltd. The authors would like to thank Lisa Law and Simon van Rysewyck for medical writing and Arjun Jain for statistical analysis. Many thanks to Derek Skinner for preparation of data for analysis.Peer reviewedPostprin

Large expert-curated database for benchmarking document similarity detection in biomedical literature search

Document recommendation systems for locating relevant literature have mostly relied on methods developed a decade ago. This is largely due to the lack of a large offline gold-standard benchmark of relevant documents that cover a variety of research fields such that newly developed literature search techniques can be compared, improved and translated into practice. To overcome this bottleneck, we have established the RElevant LIterature SearcH consortium consisting of more than 1500 scientists from 84 countries, who have collectively annotated the relevance of over 180 000 PubMed-listed articles with regard to their respective seed (input) article/s. The majority of annotations were contributed by highly experienced, original authors of the seed articles. The collected data cover 76% of all unique PubMed Medical Subject Headings descriptors. No systematic biases were observed across different experience levels, research fields or time spent on annotations. More importantly, annotations of the same document pairs contributed by different scientists were highly concordant. We further show that the three representative baseline methods used to generate recommended articles for evaluation (Okapi Best Matching 25, Term Frequency-Inverse Document Frequency and PubMed Related Articles) had similar overall performances. Additionally, we found that these methods each tend to produce distinct collections of recommended articles, suggesting that a hybrid method may be required to completely capture all relevant articles. The established database server located at https://relishdb.ict.griffith.edu.au is freely available for the downloading of annotation data and the blind testing of new methods. We expect that this benchmark will be useful for stimulating the development of new powerful techniques for title and title/abstract-based search engines for relevant articles in biomedical research.Peer reviewe

Retrospective evaluation of whole exome and genome mutation calls in 746 cancer samples

Funder: NCI U24CA211006Abstract: The Cancer Genome Atlas (TCGA) and International Cancer Genome Consortium (ICGC) curated consensus somatic mutation calls using whole exome sequencing (WES) and whole genome sequencing (WGS), respectively. Here, as part of the ICGC/TCGA Pan-Cancer Analysis of Whole Genomes (PCAWG) Consortium, which aggregated whole genome sequencing data from 2,658 cancers across 38 tumour types, we compare WES and WGS side-by-side from 746 TCGA samples, finding that ~80% of mutations overlap in covered exonic regions. We estimate that low variant allele fraction (VAF < 15%) and clonal heterogeneity contribute up to 68% of private WGS mutations and 71% of private WES mutations. We observe that ~30% of private WGS mutations trace to mutations identified by a single variant caller in WES consensus efforts. WGS captures both ~50% more variation in exonic regions and un-observed mutations in loci with variable GC-content. Together, our analysis highlights technological divergences between two reproducible somatic variant detection efforts