Pub Date : 2019-02-19DOI: 10.1186/s41073-019-0062-x
Andrew Grey, Mark Bolland, Greg Gamble, Alison Avenell
Background: Academic institutions play important roles in protecting and preserving research integrity. Concerns have been expressed about the objectivity, adequacy and transparency of institutional investigations of potentially compromised research integrity. We assessed the reports provided to us of investigations by three academic institutions of a large body of overlapping research with potentially compromised integrity.
Methods: In 2017, we raised concerns with four academic institutions about the integrity of > 200 publications co-authored by an overlapping set of researchers. Each institution initiated an investigation. By November 2018, three had reported to us the results of their investigations, but only one report was publicly available. Two investigators independently assessed each available report using a published 26-item checklist designed to determine the quality and adequacy of institutional investigations of research integrity. Each assessor recorded additional comments ad hoc.
Results: Concerns raised with the institutions were overlapping, wide-ranging and included those which were both general and publication-specific. The number of potentially affected publications at individual institutions ranged from 34 to 200. The duration of investigation by the three institutions which provided reports was 8-17 months. These investigations covered 14%, 15% and 77%, respectively, of potentially affected publications. Between-assessor agreement using the quality checklist was 0.68, 0.72 and 0.65 for each report. Only 4/78 individual checklist items were addressed adequately: a further 14 could not be assessed. Each report was graded inadequate overall. Reports failed to address publication-specific concerns and focussed more strongly on determining research misconduct than evaluating the integrity of publications.
Conclusions: Our analyses identify important deficiencies in the quality and reporting of institutional investigation of concerns about the integrity of a large body of research reported by an overlapping set of researchers. They reinforce disquiet about the ability of institutions to rigorously and objectively oversee integrity of research conducted by their own employees.
{"title":"Quality of reports of investigations of research integrity by academic institutions.","authors":"Andrew Grey, Mark Bolland, Greg Gamble, Alison Avenell","doi":"10.1186/s41073-019-0062-x","DOIUrl":"10.1186/s41073-019-0062-x","url":null,"abstract":"<p><strong>Background: </strong>Academic institutions play important roles in protecting and preserving research integrity. Concerns have been expressed about the objectivity, adequacy and transparency of institutional investigations of potentially compromised research integrity. We assessed the reports provided to us of investigations by three academic institutions of a large body of overlapping research with potentially compromised integrity.</p><p><strong>Methods: </strong>In 2017, we raised concerns with four academic institutions about the integrity of > 200 publications co-authored by an overlapping set of researchers. Each institution initiated an investigation. By November 2018, three had reported to us the results of their investigations, but only one report was publicly available. Two investigators independently assessed each available report using a published 26-item checklist designed to determine the quality and adequacy of institutional investigations of research integrity. Each assessor recorded additional comments ad hoc.</p><p><strong>Results: </strong>Concerns raised with the institutions were overlapping, wide-ranging and included those which were both general and publication-specific. The number of potentially affected publications at individual institutions ranged from 34 to 200. The duration of investigation by the three institutions which provided reports was 8-17 months. These investigations covered 14%, 15% and 77%, respectively, of potentially affected publications. Between-assessor agreement using the quality checklist was 0.68, 0.72 and 0.65 for each report. Only 4/78 individual checklist items were addressed adequately: a further 14 could not be assessed. Each report was graded inadequate overall. Reports failed to address publication-specific concerns and focussed more strongly on determining research misconduct than evaluating the integrity of publications.</p><p><strong>Conclusions: </strong>Our analyses identify important deficiencies in the quality and reporting of institutional investigation of concerns about the integrity of a large body of research reported by an overlapping set of researchers. They reinforce disquiet about the ability of institutions to rigorously and objectively oversee integrity of research conducted by their own employees.</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s41073-019-0062-x","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37173168","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-01-16eCollection Date: 2019-01-01DOI: 10.1186/s41073-018-0061-3
Eric Badu, Paul Okyere, Diane Bell, Naomi Gyamfi, Maxwell Peprah Opoku, Peter Agyei-Baffour, Anthony Kwaku Edusei
Introduction: The abstracts of a conference are important for informing the participants about the results that are communicated. However, there is poor reporting in conference abstracts in disability research. This paper aims to assess the reporting in the abstracts presented at the 5th African Network for Evidence-to-Action in Disability (AfriNEAD) Conference in Ghana.
Methods: This descriptive study extracted information from the abstracts presented at the 5th AfriNEAD Conference. Three reviewers independently reviewed all the included abstracts using a predefined data extraction form. Descriptive statistics were used to analyze the extracted information, using Stata version 15.
Results: Of the 76 abstracts assessed, 54 met the inclusion criteria, while 22 were excluded. More than half of all the included abstracts (32/54; 59.26%) were studies conducted in Ghana. Some of the included abstracts did not report on the study design (37/54; 68.5%), the type of analysis performed (30/54; 55.56%), the sampling (27/54; 50%), and the sample size (18/54; 33.33%). Almost all the included abstracts did not report the age distribution and the gender of the participants.
Conclusion: The study findings confirm that there is poor reporting of methods and findings in conference abstracts. Future conference organizers should critically examine abstracts to ensure that these issues are adequately addressed, so that findings are effectively communicated to participants.
会议摘要对于告知与会者会议的结果是非常重要的。然而,会议摘要对残疾研究的报道却很少。本文旨在评估在加纳举行的第五届非洲残疾证据行动网络(AfriNEAD)会议上提交的摘要报告。方法:本描述性研究从第5届非洲会议上发表的摘要中提取信息。三位审稿人使用预定义的数据提取表单独立审查所有包含的摘要。描述性统计用于分析提取的信息,使用Stata version 15。结果:76篇综述中,54篇符合纳入标准,22篇被排除。超过一半的收录摘要(32/54;59.26%)为在加纳进行的研究。一些纳入的摘要没有报道研究设计(37/54;68.5%),所进行的分析类型(30/54;55.56%),抽样(27/54;50%),样本量(18/54;33.33%)。几乎所有纳入的摘要都没有报告参与者的年龄分布和性别。结论:研究结果证实了会议摘要中对方法和结果的报道不足。未来的会议组织者应该严格审查摘要,以确保这些问题得到充分解决,以便将研究结果有效地传达给与会者。
{"title":"Reporting in the abstracts presented at the 5th AfriNEAD (African Network for Evidence-to-Action in Disability) Conference in Ghana.","authors":"Eric Badu, Paul Okyere, Diane Bell, Naomi Gyamfi, Maxwell Peprah Opoku, Peter Agyei-Baffour, Anthony Kwaku Edusei","doi":"10.1186/s41073-018-0061-3","DOIUrl":"https://doi.org/10.1186/s41073-018-0061-3","url":null,"abstract":"<p><strong>Introduction: </strong>The abstracts of a conference are important for informing the participants about the results that are communicated. However, there is poor reporting in conference abstracts in disability research. This paper aims to assess the reporting in the abstracts presented at the 5th African Network for Evidence-to-Action in Disability (AfriNEAD) Conference in Ghana.</p><p><strong>Methods: </strong>This descriptive study extracted information from the abstracts presented at the 5th AfriNEAD Conference. Three reviewers independently reviewed all the included abstracts using a predefined data extraction form. Descriptive statistics were used to analyze the extracted information, using Stata version 15.</p><p><strong>Results: </strong>Of the 76 abstracts assessed, 54 met the inclusion criteria, while 22 were excluded. More than half of all the included abstracts (32/54; 59.26%) were studies conducted in Ghana. Some of the included abstracts did not report on the study design (37/54; 68.5%), the type of analysis performed (30/54; 55.56%), the sampling (27/54; 50%), and the sample size (18/54; 33.33%). Almost all the included abstracts did not report the age distribution and the gender of the participants.</p><p><strong>Conclusion: </strong>The study findings confirm that there is poor reporting of methods and findings in conference abstracts. Future conference organizers should critically examine abstracts to ensure that these issues are adequately addressed, so that findings are effectively communicated to participants.</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s41073-018-0061-3","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36939596","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-01-09eCollection Date: 2019-01-01DOI: 10.1186/s41073-018-0060-4
Rik Peels
A large number of scientists and several news platforms have, over the last few years, been speaking of a replication crisis in various academic disciplines, especially the biomedical and social sciences. This paper answers the novel question of whether we should also pursue replication in the humanities. First, I create more conceptual clarity by defining, in addition to the term "humanities," various key terms in the debate on replication, such as "reproduction" and "replicability." In doing so, I pay attention to what is supposed to be the object of replication: certain studies, particular inferences, of specific results. After that, I spell out three reasons for thinking that replication in the humanities is not possible and argue that they are unconvincing. Subsequently, I give a more detailed case for thinking that replication in the humanities is possible. Finally, I explain why such replication in the humanities is not only possible, but also desirable.
{"title":"Replicability and replication in the humanities.","authors":"Rik Peels","doi":"10.1186/s41073-018-0060-4","DOIUrl":"10.1186/s41073-018-0060-4","url":null,"abstract":"<p><p>A large number of scientists and several news platforms have, over the last few years, been speaking of a replication crisis in various academic disciplines, especially the biomedical and social sciences. This paper answers the novel question of whether we should also pursue replication in the humanities. First, I create more conceptual clarity by defining, in addition to the term \"humanities,\" various key terms in the debate on replication, such as \"reproduction\" and \"replicability.\" In doing so, I pay attention to what is supposed to be the object of replication: certain studies, particular inferences, of specific results. After that, I spell out three reasons for thinking that replication in the humanities is not possible and argue that they are unconvincing. Subsequently, I give a more detailed case for thinking that replication in the humanities is possible. Finally, I explain why such replication in the humanities is not only possible, but also desirable.</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6348612/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36918266","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-12-20DOI: 10.1186/s41073-019-0073-7
O. Evuarherhe, W. Gattrell, Richard White, C. Winchester
{"title":"Professional medical writing support and the quality, ethics and timeliness of clinical trial reporting: a systematic review","authors":"O. Evuarherhe, W. Gattrell, Richard White, C. Winchester","doi":"10.1186/s41073-019-0073-7","DOIUrl":"https://doi.org/10.1186/s41073-019-0073-7","url":null,"abstract":"","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s41073-019-0073-7","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46108951","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-12-19eCollection Date: 2018-01-01DOI: 10.1186/s41073-018-0056-0
Zoë H Hammatt
{"title":"Commentary: a broader perspective on the RePAIR consensus guidelines (Responsibilities of Publishers, Agencies, Institutions, and Researchers in protecting the integrity of the research record).","authors":"Zoë H Hammatt","doi":"10.1186/s41073-018-0056-0","DOIUrl":"https://doi.org/10.1186/s41073-018-0056-0","url":null,"abstract":"","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s41073-018-0056-0","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36868877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-12-19eCollection Date: 2018-01-01DOI: 10.1186/s41073-018-0055-1
The progression of research and scholarly inquiry does not occur in isolation and is wholly dependent on accurate reporting of methods and results, and successful replication of prior work. Without mechanisms to correct the literature, much time and money is wasted on research based on a crumbling foundation. These guidelines serve to outline the respective responsibilities of researchers, institutions, agencies, and publishers or editors in maintaining the integrity of the research record. Delineating these complementary roles and proposing solutions for common barriers provide a foundation for best practices.
{"title":"RePAIR consensus guidelines: Responsibilities of Publishers, Agencies, Institutions, and Researchers in protecting the integrity of the research record.","authors":"","doi":"10.1186/s41073-018-0055-1","DOIUrl":"10.1186/s41073-018-0055-1","url":null,"abstract":"<p><p>The progression of research and scholarly inquiry does not occur in isolation and is wholly dependent on accurate reporting of methods and results, and successful replication of prior work. Without mechanisms to correct the literature, much time and money is wasted on research based on a crumbling foundation. These guidelines serve to outline the respective responsibilities of researchers, institutions, agencies, and publishers or editors in maintaining the integrity of the research record. Delineating these complementary roles and proposing solutions for common barriers provide a foundation for best practices.</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6299642/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36868878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-11-26eCollection Date: 2018-01-01DOI: 10.1186/s41073-018-0059-x
Jigisha Patel
Manipulation of the publication process is a relatively new form of misconduct affecting the publishing industry. This editorial describes what it is, why it is difficult for individual journal editors and publishers to handle and the background to the development of the new COPE guidelines on how to manage publication process manipulation. These new guidelines represent an important first step towards encouraging openness and collaboration between publishers to address this phenomenon.
{"title":"New COPE guidelines on publication process manipulation: why they matter.","authors":"Jigisha Patel","doi":"10.1186/s41073-018-0059-x","DOIUrl":"https://doi.org/10.1186/s41073-018-0059-x","url":null,"abstract":"<p><p>Manipulation of the publication process is a relatively new form of misconduct affecting the publishing industry. This editorial describes what it is, why it is difficult for individual journal editors and publishers to handle and the background to the development of the new COPE guidelines on how to manage publication process manipulation. These new guidelines represent an important first step towards encouraging openness and collaboration between publishers to address this phenomenon.</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s41073-018-0059-x","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36788495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-11-16eCollection Date: 2018-01-01DOI: 10.1186/s41073-018-0057-z
Zen Faulkes
Background: Disputes over authorship are increasing. This paper examines the options that researchers have in resolving authorship disputes. Discussions about authorship disputes often address how to prevent disputes but rarely address how to resolve them. Both individuals and larger research communities are harmed by the limited options for dispute resolution.
Main body: When authorship disputes arise after publication, most existing guidelines recommend that the authors work out the disputes between themselves. But this is unlikely to occur, because there are often large power differentials between team members, and institutions (e.g., universities, funding agencies) are unlikely to have authority over all team members. Other collaborative disciplines that deal with issues of collaborative creator credit could provide models for scientific authorship. Arbitration or mediation could provide solutions to authorship disputes where few presently exist. Because authors recognize journals' authority to make decisions about manuscripts submitted to the journal, journals are well placed to facilitate alternative dispute resolution processes.
Conclusion: Rather than viewing authorship disputes as rare events that must be handled on a case by case basis, researchers and journals should view the potential for disputes as predictable, preventable, and soluble. Independent bodies that can offer alternative dispute resolution services to scientific collaborators and/or journals could quickly help research communities, particularly their most vulnerable members.
{"title":"Resolving authorship disputes by mediation and arbitration.","authors":"Zen Faulkes","doi":"10.1186/s41073-018-0057-z","DOIUrl":"10.1186/s41073-018-0057-z","url":null,"abstract":"<p><strong>Background: </strong>Disputes over authorship are increasing. This paper examines the options that researchers have in resolving authorship disputes. Discussions about authorship disputes often address how to prevent disputes but rarely address how to resolve them. Both individuals and larger research communities are harmed by the limited options for dispute resolution.</p><p><strong>Main body: </strong>When authorship disputes arise after publication, most existing guidelines recommend that the authors work out the disputes between themselves. But this is unlikely to occur, because there are often large power differentials between team members, and institutions (e.g., universities, funding agencies) are unlikely to have authority over all team members. Other collaborative disciplines that deal with issues of collaborative creator credit could provide models for scientific authorship. Arbitration or mediation could provide solutions to authorship disputes where few presently exist. Because authors recognize journals' authority to make decisions about manuscripts submitted to the journal, journals are well placed to facilitate alternative dispute resolution processes.</p><p><strong>Conclusion: </strong>Rather than viewing authorship disputes as rare events that must be handled on a case by case basis, researchers and journals should view the potential for disputes as predictable, preventable, and soluble. Independent bodies that can offer alternative dispute resolution services to scientific collaborators and/or journals could quickly help research communities, particularly their most vulnerable members.</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6240247/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36715241","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-11-14eCollection Date: 2018-01-01DOI: 10.1186/s41073-018-0058-y
S P J M Serge Horbach, W Willem Halffman
[This corrects the article DOI: 10.1186/s41073-018-0051-5.].
[这更正了文章DOI: 10.1186/ s4473 -018-0051-5.]。
{"title":"Correction to: The changing forms and expectations of peer review.","authors":"S P J M Serge Horbach, W Willem Halffman","doi":"10.1186/s41073-018-0058-y","DOIUrl":"https://doi.org/10.1186/s41073-018-0058-y","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1186/s41073-018-0051-5.].</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s41073-018-0058-y","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36751919","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-10-29eCollection Date: 2018-01-01DOI: 10.1186/s41073-018-0053-3
Linda Kwakkenbos, Edmund Juszczak, Lars G Hemkens, Margaret Sampson, Ole Fröbert, Clare Relton, Chris Gale, Merrick Zwarenstein, Sinéad M Langan, David Moher, Isabelle Boutron, Philippe Ravaud, Marion K Campbell, Kimberly A Mc Cord, Tjeerd P van Staa, Lehana Thabane, Rudolf Uher, Helena M Verkooijen, Eric I Benchimol, David Erlinge, Maureen Sauvé, David Torgerson, Brett D Thombs
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 for an in-person consensus meeting to finalize a core set of items to be included in the reporting guideline and checklist. Phase 5 will involve drafting the checklist and elaboration-explanation documents, and dissemination and implementation of the guideline.
Discussion: Development of this CONSORT extension will contribute to more transparent reporting of RCTs conducted using cohorts and routinely collected health data.
{"title":"Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data.","authors":"Linda Kwakkenbos, Edmund Juszczak, Lars G Hemkens, Margaret Sampson, Ole Fröbert, Clare Relton, Chris Gale, Merrick Zwarenstein, Sinéad M Langan, David Moher, Isabelle Boutron, Philippe Ravaud, Marion K Campbell, Kimberly A Mc Cord, Tjeerd P van Staa, Lehana Thabane, Rudolf Uher, Helena M Verkooijen, Eric I Benchimol, David Erlinge, Maureen Sauvé, David Torgerson, Brett D Thombs","doi":"10.1186/s41073-018-0053-3","DOIUrl":"10.1186/s41073-018-0053-3","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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 for an in-person consensus meeting to finalize a core set of items to be included in the reporting guideline and checklist. Phase 5 will involve drafting the checklist and elaboration-explanation documents, and dissemination and implementation of the guideline.</p><p><strong>Discussion: </strong>Development of this CONSORT extension will contribute to more transparent reporting of RCTs conducted using cohorts and routinely collected health data.</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6205772/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9105072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}