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14 results on '"Benchimol, E.I."'

1. CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): Checklist with explanation and elaboration

Author

Kwakkenbos, L., Imran, M., McCall, S.J., McCord, K.A., Fröbert, O., Hemkens, L.G., Zwarenstein, M., Relton, C., Rice, D.B., Langan, S.M., Benchimol, E.I., Thabane, L., Campbell, M.K., Sampson, M., Erlinge, D., Verkooijen, H.M., Moher, D., Boutron, I., Ravaud, P., Nicholl, J., Uher, R., Sauvé, M., Fletcher, J., Torgerson, D., Gale, C., Juszczak, E., Thombs, B.D., Kwakkenbos, L., Imran, M., McCall, S.J., McCord, K.A., Fröbert, O., Hemkens, L.G., Zwarenstein, M., Relton, C., Rice, D.B., Langan, S.M., Benchimol, E.I., Thabane, L., Campbell, M.K., Sampson, M., Erlinge, D., Verkooijen, H.M., Moher, D., Boutron, I., Ravaud, P., Nicholl, J., Uher, R., Sauvé, M., Fletcher, J., Torgerson, D., Gale, C., Juszczak, E., and Thombs, B.D.

Abstract

Contains fulltext : 234331.pdf (Publisher’s version ) (Open Access)

Published
2021

2. Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE)

Author

Imran, M., Kwakkenbos, L., McCall, S.J., McCord, K.A., Fröbert, O., Hemkens, L.G., Zwarenstein, M., Relton, C., Rice, D.B., Langan, S.M., Benchimol, E.I., Thabane, L., Campbell, M.K., Sampson, M., Erlinge, D., Verkooijen, H.M., Moher, D., Boutron, I., Ravaud, P., Nicholl, J., Uher, R., Sauvé, M., Fletcher, J., Torgerson, D., Gale, C., Juszczak, E., Thombs, B.D., Imran, M., Kwakkenbos, L., McCall, S.J., McCord, K.A., Fröbert, O., Hemkens, L.G., Zwarenstein, M., Relton, C., Rice, D.B., Langan, S.M., Benchimol, E.I., Thabane, L., Campbell, M.K., Sampson, M., Erlinge, D., Verkooijen, H.M., Moher, D., Boutron, I., Ravaud, P., Nicholl, J., Uher, R., Sauvé, M., Fletcher, J., Torgerson, D., Gale, C., Juszczak, E., and Thombs, B.D.

Abstract

Contains fulltext : 234358.pdf (Publisher’s version ) (Open Access), Objectives: Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) has been developed with the goal of improving reporting quality. This article describes the processes and methods used to develop the extension and decisions made to arrive at the final checklist. Methods: The development process involved five stages: (1) identification of the need for a reporting guideline and project launch; (2) conduct of a scoping review to identify possible modifications to CONSORT 2010 checklist items and possible new extension items; (3) a three-round modified Delphi study involving key stakeholders to gather feedback on the checklist; (4) a consensus meeting to finalise items to be included in the extension, followed by stakeholder piloting of the checklist; and (5) publication, dissemination and implementation of the final checklist. Results: 27 items were initially developed and rated in Delphi round 1, 13 items were rated in round 2 and 11 items were rated in round 3. Response rates for the Delphi study were 92 of 125 (74%) invited participants in round 1, 77 of 92 (84%) round 1 completers in round 2 and 62 of 77 (81%) round 2 completers in round 3. Twenty-seven members of the project team representing a variety of stakeholder groups attended the in-person consensus meeting. The final checklist includes five new items and eight modified items. The extension Explanation & Elaboration document further clarifies aspects that are important to report. Conclusion: Uptake of CONSORT-ROUTINE and accompanying Explanation & Elaboration document will improve conduct of trials, as well as the transparency and completeness of reporting of trials conducted using

Published
2021

3. Increasing incidence of paediatric inflammatory bowel disease in Ontario, Canada: evidence from health administrative data

Author

Benchimol, E.I., Guttmann, A., Griffiths, A.M., Rabeneck, L., Mack, D.R., Brill, H., Howard, J., Guan, J., and To, T.

Subjects
Inflammatory bowel diseases -- Distribution, Inflammatory bowel diseases -- Demographic aspects, Inflammatory bowel diseases -- Research, Medical protocols -- Information management, Medical protocols -- Research, Health services administration -- Information management, Health services administration -- Research, Company systems management, Company distribution practices, Health
Published
2009

4. Severe paediatric ulcerative colitis: incidence, outcomes and optimal timing for second-line therapy

Author

Turner, D., Walsh, C.M., Benchimol, E.I., Mann, E.H., Thomas, K.E., Chow, C., McLernon, R.A., Walters, T.D., Swales, J., Steinhart, A.H., and Griffiths, A.M.

Subjects
Ulcerative colitis -- Demographic aspects, Ulcerative colitis -- Care and treatment, Ulcerative colitis -- Patient outcomes, Ulcerative colitis -- Research, Children -- Diseases, Children -- Care and treatment, Children -- Patient outcomes, Children -- Research, Health
Published
2008

5. Introducing the CONsolidated Standards of Reporting Trials (CONSORT) statement for randomised controlled trials (RCTs) using cohorts and routinely collected health data

Author

Juszczak, E., Kwakkenbos, L., McCall, S.J., Imran, M., Hemkens, L.G., Zwarenstein, M., Fröbert, O., Relton, C., Sampson, M., Thabane, L., Benchimol, E.I., Campbell, M.K., Torgerson, D., Erlinge, D., Rice, D.B., Langan, S.M., McCord, K.A., Staa, T.P. van, Moher, D., Verkooijen, H.M., Uher, R., Worron-Sauve, M.B., Boutron, I., Ravaud, P., Thombs, B.D., Gale, C., Juszczak, E., Kwakkenbos, L., McCall, S.J., Imran, M., Hemkens, L.G., Zwarenstein, M., Fröbert, O., Relton, C., Sampson, M., Thabane, L., Benchimol, E.I., Campbell, M.K., Torgerson, D., Erlinge, D., Rice, D.B., Langan, S.M., McCord, K.A., Staa, T.P. van, Moher, D., Verkooijen, H.M., Uher, R., Worron-Sauve, M.B., Boutron, I., Ravaud, P., Thombs, B.D., and Gale, C.

Abstract

Contains fulltext : 209458.pdf (publisher's version ) (Open Access), Background: Randomised controlled trials (RCTs) are increasingly being conducted using existing sources of data, such as cohorts, administrative databases, disease registries and electronic health records. RCTs conducted using existing data sources require additional information to be reported. This reporting guideline is an extension of the 2010 version of the Consolidated Standards of Reporting Trials (CONSORT) Statement for RCTs using cohorts and routinely collected health data. Methods: A long-list of potential items for the checklist was identified through two methods: firstly, modifications to the current CONSORT checklist were generated using existing reporting guidelines, including the Reporting of Observational Studies in Epidemiology (STROBE) and REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Secondly, ascoping review of RCTs conducted in the last decade using cohorts and routinely collected health data facilitated the modification and identification of other potential items. Using the long-list, a three-stage Delphi exercise was conducted to assess the importance of each item for inclusion in the final extension checklist, which was finalised at a face-to-face meeting of experts. Results: A long-list of 27 items was created and 125 experts registered for the three-round Delphi exercise (92, 77 and 62 experts participated in each round respectively). Consensus was reached on 21 out of 27 items. The results of the Delphi exercise informed a face-to-face consensus meeting in May 2019; core items to be included in the extension checklist were finalised at this meeting. Corresponding explanations of extensions and new items with examples of good reporting were developed subsequently. Conclusion: The guideline checklist can facilitate transparent reporting of RCTs using cohorts and routinely collected health data, to assist evaluations of rigour and reproducibility, enhance understanding of the methodolog

Published
2019

6. Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data

Author

Kwakkenbos, L., Imran, M., McCord, K.A., Sampson, M., Fröbert, O., Gale, C., Hemkens, L.G., Langan, S.M., Moher, D., Relton, C., Zwarenstein, M., Benchimol, E.I., Boutron, I., Campbell, M.K., Erlinge, D., Jawad, S., Ravaud, P., Rice, D.B., Sauvé, M., Staa, T.P. van, Thabane, L., Uher, R., Verkooijen, H.M., Juszczak, E., Thombs, B.D., Kwakkenbos, L., Imran, M., McCord, K.A., Sampson, M., Fröbert, O., Gale, C., Hemkens, L.G., Langan, S.M., Moher, D., Relton, C., Zwarenstein, M., Benchimol, E.I., Boutron, I., Campbell, M.K., Erlinge, D., Jawad, S., Ravaud, P., Rice, D.B., Sauvé, M., Staa, T.P. van, Thabane, L., Uher, R., Verkooijen, H.M., Juszczak, E., and Thombs, B.D.

Abstract

Contains fulltext : 194062.pdf (publisher's version ) (Open Access), Introduction: Randomised controlled trials (RCTs) conducted using cohorts and routinely collected health data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. The development of an extension of the CONsolidated Standards of Reporting Trials (CONSORT) statement for RCTs using cohorts and routinely collected health data is being undertaken with the goal of improving reporting quality by setting standards early in the process of uptake of these designs. To develop this extension to the CONSORT statement, a scoping review will be conducted to identify potential modifications or clarifications of existing reporting guideline items, as well as additional items needed for reporting RCTs using cohorts and routinely collected health data. Methods and analysis: In separate searches, we will seek publications on methods or reporting or that describe protocols or results from RCTs using cohorts, registries, electronic health records and administrative databases. Data sources will include Medline and the Cochrane Methodology Register. For each of the four main types of RCTs using cohorts and routinely collected health data, separately, two investigators will independently review included publications to extract potential checklist items. A potential item will either modify an existing CONSORT 2010, Strengthening the Reporting of Observational Studies in Epidemiology or REporting of studies Conducted using Observational Routinely collected health Data item or will be proposed as a new item. Additionally, we will identify examples of good reporting in RCTs using cohorts and routinely collected health data. Ethics and dissemination: The proposed scoping review will help guide the development of the CONSORT extension statement for RCTs conducted using cohorts and routinely collected health data.

Published
2018

7. Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data

Author

Kwakkenbos, L., Juszczak, E., Hemkens, L.G., Sampson, M., Fröbert, O., Relton, C., Gale, C., Zwarenstein, M., Langan, S.M., Moher, D., Boutron, I., Ravaud, P., Campbell, M.K., McCord, K.A., Staa, T.P. van, Thabane, L., Uher, R., Verkooijen, H.M., Benchimol, E.I., Erlinge, D., Sauvé, M., Torgerson, D., Thombs, B.D., Kwakkenbos, L., Juszczak, E., Hemkens, L.G., Sampson, M., Fröbert, O., Relton, C., Gale, C., Zwarenstein, M., Langan, S.M., Moher, D., Boutron, I., Ravaud, P., Campbell, M.K., McCord, K.A., Staa, T.P. van, Thabane, L., Uher, R., Verkooijen, H.M., Benchimol, E.I., Erlinge, D., Sauvé, M., Torgerson, D., and Thombs, B.D.

Abstract

Contains fulltext : 197751.pdf (publisher's version ) (Open Access), Background: Randomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of their methodology in a standardized way. Our objective is to extend the Consolidated Standards of Reporting Trials (CONSORT) statement with a consensus-driven reporting guideline for RCTs using cohorts and routinely collected health data. Methods: The development of this CONSORT extension will consist of five phases. Phase 1 (completed) consisted of the project launch, including fundraising, the establishment of a research team, and development of a conceptual framework. In phase 2, a systematic review will be performed to identify publications (1) that describe methods or reporting considerations for RCTs conducted using cohorts and routinely collected health data or (2) that are protocols or report results from such RCTs. An initial "long list" of possible modifications to CONSORT checklist items and possible new items for the reporting guideline will be generated based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Additional possible modifications and new items will be identified based on the results of the systematic review. Phase 3 will consist of a three-round Delphi exercise with methods and content experts to evaluate the "long list" and generate a "short list" of key items. In phase 4, these items will serve as the basis fo

Published
2018

8. Das RECORD-Statement zum Berichten von Beobachtungsstudien, die routinemäßig gesammelte Gesundheitsdaten verwenden [The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement]

Author

Benchimol, E.I., Smeeth, L., Guttmann, A., Harron, K., Hemkens, L.G., Moher, D., Petersen, I., Sørensen, H.T., von Elm, E., Langan, S.M., and RECORD Working Committee

Subjects
Biomedical Research, Checklist, Data Collection, Germany, Guidelines as Topic, Humans, Research Report/standards, Administrative Gesundheitsdaten, Beobachtungsstudien, CPRD, Clinical Practice Research Datalink, Datenbanken zur Grundversorgung, Dokumentation, Elektronische Gesundheitsdaten, Epidemiologische Methoden, Fall-Kontroll-Studien, GPRD, General Practice Research Database, Gesundheitsbezogene Routinedaten, HSMR, Hospital Standardised Mortality Ratio, ICD, ISC, Informationsverbreitung, International Classification of Diseases, Kohortenstudien, Konsensus, Leitlinien für Forschungsberichte, MDC, MeSH, Medical Subject Heading, Medizinischen Zeitschriften, NHS, NSCLC, National Health Service, New South Wales Inpatient Statistics Collection, New South Wales Midwives Data Collection, Non-Small Cell Lung Cancer, PET, PICANet, Paediatric Intensive Care Audit Network, Positronen-Emissions-Tomographie, Publizieren, RECORD, REporting of studies Conducted using Observational Routinely collected health Data, SEER, SNIIRAM, STROBE, Strengthening the Reporting of Observational Studies in Epidemiology, Surveillance, Epidemiology, and End Results, Système National d’Informations Inter Régimes de l’Assurance Maladie, Wissenschaftliche Zeitschriften, Wissensverbreitung, Zeitschriften mit Peer-Review, case-control studies, cohort studies, consensus, documentation, electronic health data, epidemiologic methods, health administrative data, information dissemination, knowledge dissemination, mHealth-Apps, medical journals, mobile Gesundheitsapplikationen, observational research, publishing, reporting guidelines, routinely collected health data, scientific journals
Abstract

Routinely collected health data, obtained for administrative and clinical purposes without specific a priori research goals, are increasingly used for research. The rapid evolution and availability of these data have revealed issues not addressed by existing reporting guidelines, such as Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement was created to fill these gaps. RECORD was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD consists of a checklist of 13 items related to the title, abstract, introduction, methods, results, and discussion section of articles, and other information required for inclusion in such research reports. This document contains the checklist as well as explanatory and elaboration information to enhance the use of the checklist. Examples of good reporting for each RECORD checklist item are also included. This document, as well as the accompanying website and message board (http://www.record-statement.org), will improve the implementation and understanding of RECORD. By implementing RECORD, authors, journals editors, and peer reviewers can enhance transparency of research reporting.

Published
2016

9. The REporting of Studies Conducted Using Observational Routinely-Collected Health Data (RECORD) Statement: Methods for Arriving at Consensus and Developing Reporting Guidelines

Author

Nicholls, S.G., Quach, P., von Elm, E., Guttmann, A., Moher, D., Petersen, I., Sørensen, H.T., Smeeth, L., Langan, S.M., and Benchimol, E.I.

Subjects
Adolescent, Adult, Aged, Consensus, Database Management Systems, Female, Guidelines as Topic, Humans, Male, Medical Records/standards, Middle Aged, Observational Studies as Topic, Surveys and Questionnaires
Abstract

Routinely collected health data, collected for administrative and clinical purposes, without specific a priori research questions, are increasingly used for observational, comparative effectiveness, health services research, and clinical trials. The rapid evolution and availability of routinely collected data for research has brought to light specific issues not addressed by existing reporting guidelines. The aim of the present project was to determine the priorities of stakeholders in order to guide the development of the REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. Two modified electronic Delphi surveys were sent to stakeholders. The first determined themes deemed important to include in the RECORD statement, and was analyzed using qualitative methods. The second determined quantitative prioritization of the themes based on categorization of manuscript headings. The surveys were followed by a meeting of RECORD working committee, and re-engagement with stakeholders via an online commentary period. The qualitative survey (76 responses of 123 surveys sent) generated 10 overarching themes and 13 themes derived from existing STROBE categories. Highest-rated overall items for inclusion were: Disease/exposure identification algorithms; Characteristics of the population included in databases; and Characteristics of the data. In the quantitative survey (71 responses of 135 sent), the importance assigned to each of the compiled themes varied depending on the manuscript section to which they were assigned. Following the working committee meeting, online ranking by stakeholders provided feedback and resulted in revision of the final checklist. The RECORD statement incorporated the suggestions provided by a large, diverse group of stakeholders to create a reporting checklist specific to observational research using routinely collected health data. Our findings point to unique aspects of studies conducted with routinely collected health data and the perceived need for better reporting of methodological issues.

Published
2015

10. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement

Author

Benchimol, E.I., Smeeth, L., Guttmann, A., Harron, K., Moher, D., Petersen, I., Sørensen, H.T., von Elm, E., Langan, S.M., RECORD Working Committee, Altman, D., de Klerk, N., Hemkens, LG., Henry, D., Januel, JM., Le Pogam LA., Manuel, D., Patrick, K., Perel, P., Romano, PS., Tugwell, P., Warren, J., Weber, W., and Winker, M.

Subjects
Biomedical Research, Checklist, Guidelines as Topic, Observational Studies as Topic, Research Design, Research Report/standards
Abstract

Routinely collected health data, obtained for administrative and clinical purposes without specific a priori research goals, are increasingly used for research. The rapid evolution and availability of these data have revealed issues not addressed by existing reporting guidelines, such as Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement was created to fill these gaps. RECORD was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD consists of a checklist of 13 items related to the title, abstract, introduction, methods, results, and discussion section of articles, and other information required for inclusion in such research reports. This document contains the checklist and explanatory and elaboration information to enhance the use of the checklist. Examples of good reporting for each RECORD checklist item are also included herein. This document, as well as the accompanying website and message board (http://www.record-statement.org), will enhance the implementation and understanding of RECORD. Through implementation of RECORD, authors, journals editors, and peer reviewers can encourage transparency of research reporting.

Published
2015

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