Tamarinde L Haven, Marije Esther Evalien de Goede, Joeri K Tijdink, Frans Jeroen Oort
{"title":"Personally perceived publication pressure: revising the Publication Pressure Questionnaire (PPQ) by using work stress models.","authors":"Tamarinde L Haven, Marije Esther Evalien de Goede, Joeri K Tijdink, Frans Jeroen Oort","doi":"10.1186/s41073-019-0066-6","DOIUrl":"https://doi.org/10.1186/s41073-019-0066-6","url":null,"abstract":"<p><strong>Background: </strong>The emphasis on impact factors and the quantity of publications intensifies competition between researchers. This competition was traditionally considered an incentive to produce high-quality work, but there are unwanted side-effects of this competition like publication pressure. To measure the effect of publication pressure on researchers, the Publication Pressure Questionnaire (PPQ) was developed. Upon using the PPQ, some issues came to light that motivated a revision.</p><p><strong>Method: </strong>We constructed two new subscales based on work stress models using the facet method. We administered the revised PPQ (PPQr) to a convenience sample together with the Maslach Burnout Inventory (MBI) and the Work Design Questionnaire (WDQ). To assess which items best measured publication pressure, we carried out a principal component analysis (PCA). Reliability was sufficient when Cronbach's alpha > 0.7. Finally, we administered the PPQr in a larger, independent sample of researchers to check the reliability of the revised version.</p><p><strong>Results: </strong>Three components were identified as 'stress', 'attitude', and 'resources'. We selected 3 × 6 = 18 items with high loadings in the three-component solution. Based on the convenience sample, Cronbach's alphas were 0.83 for stress, 0.80 for attitude, and 0.76 for resources. We checked the validity of the PPQr by inspecting the correlations with the MBI and the WDQ. Stress correlated 0.62 with MBI's emotional exhaustion. Resources correlated 0.50 with relevant WDQ subscales. To assess the internal structure of the PPQr in the independent reliability sample, we conducted the principal component analysis. The three-component solution explains 50% of the variance. Cronbach's alphas were 0.80, 0.78, and 0.75 for stress, attitude, and resources, respectively.</p><p><strong>Conclusion: </strong>We conclude that the PPQr is a valid and reliable instrument to measure publication pressure in academic researchers from all disciplinary fields. The PPQr strongly relates to burnout and could also be beneficial for policy makers and research institutions to assess the degree of publication pressure in their institute.</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":"4 ","pages":"7"},"PeriodicalIF":0.0,"publicationDate":"2019-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s41073-019-0066-6","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37347931","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}
M J E Urlings, B Duyx, G M H Swaen, L M Bouter, M P Zeegers
{"title":"Selective citation in scientific literature on the human health effects of bisphenol A.","authors":"M J E Urlings, B Duyx, G M H Swaen, L M Bouter, M P Zeegers","doi":"10.1186/s41073-019-0065-7","DOIUrl":"https://doi.org/10.1186/s41073-019-0065-7","url":null,"abstract":"<p><strong>Introduction: </strong>Bisphenol A is highly debated and studied in relation to a variety of health outcomes. This large variation in the literature makes BPA a topic that is prone to selective use of literature, in order to underpin one's own findings and opinion. Over time, selective use of literature, by means of citations, can lead to a skewed knowledge development and a biased scientific consensus. In this study, we assess which factors drive citation and whether this results in the overrepresentation of harmful health effects of BPA.</p><p><strong>Methods: </strong>A citation network analysis was performed to test various determinants of citation. A systematic search identified all relevant publications on the human health effect of BPA. Data were extracted on potential determinants of selective citation, such as study outcome, study design, sample size, journal impact factor, authority of the author, self-citation, and funding source. We applied random effect logistic regression to assess whether these determinants influence the likelihood of citation.</p><p><strong>Results: </strong>One hundred sixty-nine publications on BPA were identified, with 12,432 potential citation pathways of which 808 citations occurred. The network consisted of 63 cross-sectional studies, 34 cohort studies, 29 case-control studies, 35 narrative reviews, and 8 systematic reviews. Positive studies have a 1.5 times greater chance of being cited compared to negative studies. Additionally, the authority of the author and self-citation are consistently found to be positively associated with the likelihood of being cited. Overall, the network seems to be highly influenced by two highly cited publications, whereas 60 out of 169 publications received no citations.</p><p><strong>Conclusion: </strong>In the literature on BPA, citation is mostly driven by positive study outcome and author-related factors, such as high authority within the network. Interpreting the impact of these factors and the big influence of a few highly cited publications, it can be questioned to which extent the knowledge development in human literature on BPA is actually evidence-based.</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":"4 ","pages":"6"},"PeriodicalIF":0.0,"publicationDate":"2019-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s41073-019-0065-7","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37144238","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}
Christopher Baethge, Sandra Goldbeck-Wood, Stephan Mertens
{"title":"SANRA-a scale for the quality assessment of narrative review articles.","authors":"Christopher Baethge, Sandra Goldbeck-Wood, Stephan Mertens","doi":"10.1186/s41073-019-0064-8","DOIUrl":"https://doi.org/10.1186/s41073-019-0064-8","url":null,"abstract":"<p><strong>Background: </strong>Narrative reviews are the commonest type of articles in the medical literature. However, unlike systematic reviews and randomized controlled trials (RCT) articles, for which formal instruments exist to evaluate quality, there is currently no instrument available to assess the quality of narrative reviews. In response to this gap, we developed SANRA, the Scale for the Assessment of Narrative Review Articles.</p><p><strong>Methods: </strong>A team of three experienced journal editors modified or deleted items in an earlier SANRA version based on face validity, item-total correlations, and reliability scores from previous tests. We deleted an item which addressed a manuscript's writing and accessibility due to poor inter-rater reliability. The six items which form the revised scale are rated from 0 (low standard) to 2 (high standard) and cover the following topics: explanation of (1) the importance and (2) the aims of the review, (3) literature search and (4) referencing and presentation of (5) evidence level and (6) relevant endpoint data. For all items, we developed anchor definitions and examples to guide users in filling out the form. The revised scale was tested by the same editors (blinded to each other's ratings) in a group of 30 consecutive non-systematic review manuscripts submitted to a general medical journal.</p><p><strong>Results: </strong>Raters confirmed that completing the scale is feasible in everyday editorial work. The mean sum score across all 30 manuscripts was 6.0 out of 12 possible points (SD 2.6, range 1-12). Corrected item-total correlations ranged from 0.33 (item 3) to 0.58 (item 6), and Cronbach's alpha was 0.68 (internal consistency). The intra-class correlation coefficient (average measure) was 0.77 [95% CI 0.57, 0.88] (inter-rater reliability). Raters often disagreed on items 1 and 4.</p><p><strong>Conclusions: </strong>SANRA's feasibility, inter-rater reliability, homogeneity of items, and internal consistency are sufficient for a scale of six items. Further field testing, particularly of validity, is desirable. We recommend rater training based on the \"explanations and instructions\" document provided with SANRA. In editorial decision-making, SANRA may complement journal-specific evaluation of manuscripts-pertaining to, e.g., audience, originality or difficulty-and may contribute to improving the standard of non-systematic reviews.</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":"4 ","pages":"5"},"PeriodicalIF":0.0,"publicationDate":"2019-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s41073-019-0064-8","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37309816","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}
C. F. D. Carneiro, Victor G. S. Queiroz, T. Moulin, Carlos A. M. Carvalho, C. Haas, Danielle Rayêe, D. Henshall, Evandro A. De-Souza, F. E. Amorim, Flávia Z. Boos, G. Guercio, Igor R. Costa, K. Hajdu, L. V. van Egmond, M. Modrák, Pedro B. Tan, Richard J. Abdill, S. Burgess, Sylvia F. S. Guerra, V. T. Bortoluzzi, O. Amaral
{"title":"Comparing quality of reporting between preprints and peer-reviewed articles in the biomedical literature","authors":"C. F. D. Carneiro, Victor G. S. Queiroz, T. Moulin, Carlos A. M. Carvalho, C. Haas, Danielle Rayêe, D. Henshall, Evandro A. De-Souza, F. E. Amorim, Flávia Z. Boos, G. Guercio, Igor R. Costa, K. Hajdu, L. V. van Egmond, M. Modrák, Pedro B. Tan, Richard J. Abdill, S. Burgess, Sylvia F. S. Guerra, V. T. Bortoluzzi, O. Amaral","doi":"10.1101/581892","DOIUrl":"https://doi.org/10.1101/581892","url":null,"abstract":"Background Preprint usage is growing rapidly in the life sciences; however, questions remain on the relative quality of preprints when compared to published articles. An objective dimension of quality that is readily measurable is completeness of reporting, as transparency can improve the reader’s ability to independently interpret data and reproduce findings. Methods In this observational study, we initially compared independent samples of articles published in bioRxiv and in PubMed-indexed journals in 2016 using a quality of reporting questionnaire. After that, we performed paired comparisons between preprints from bioRxiv to their own peer-reviewed versions in journals. Results Peer-reviewed articles had, on average, higher quality of reporting than preprints, although the difference was small, with absolute differences of 5.0% [95% CI 1.4, 8.6] and 4.7% [95% CI 2.4, 7.0] of reported items in the independent samples and paired sample comparison, respectively. There were larger differences favoring peer-reviewed articles in subjective ratings of how clearly titles and abstracts presented the main findings and how easy it was to locate relevant reporting information. Changes in reporting from preprints to peer-reviewed versions did not correlate with the impact factor of the publication venue or with the time lag from bioRxiv to journal publication. Conclusions Our results suggest that, on average, publication in a peer-reviewed journal is associated with improvement in quality of reporting. They also show that quality of reporting in preprints in the life sciences is within a similar range as that of peer-reviewed articles, albeit slightly lower on average, supporting the idea that preprints should be considered valid scientific contributions.","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":"5 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41784313","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}
{"title":"Guidelines for open peer review implementation.","authors":"Tony Ross-Hellauer, Edit Görögh","doi":"10.1186/s41073-019-0063-9","DOIUrl":"10.1186/s41073-019-0063-9","url":null,"abstract":"<p><p>Open peer review (OPR) is moving into the mainstream, but it is often poorly understood and surveys of researcher attitudes show important barriers to implementation. As more journals move to implement and experiment with the myriad of innovations covered by this term, there is a clear need for best practice guidelines to guide implementation. This brief article aims to address this knowledge gap, reporting work based on an interactive stakeholder workshop to create best-practice guidelines for editors and journals who wish to transition to OPR. Although the advice is aimed mainly at editors and publishers of scientific journals, since this is the area in which OPR is at its most mature, many of the principles may also be applicable for the implementation of OPR in other areas (e.g., books, conference submissions).</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":"4 ","pages":"4"},"PeriodicalIF":0.0,"publicationDate":"2019-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s41073-019-0063-9","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37045643","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}
Andrew Grey, Mark Bolland, Greg Gamble, Alison Avenell
{"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":"4 ","pages":"3"},"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}
Eric Badu, Paul Okyere, Diane Bell, Naomi Gyamfi, Maxwell Peprah Opoku, Peter Agyei-Baffour, Anthony Kwaku Edusei
{"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":"4 ","pages":"1"},"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}
{"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":"4 ","pages":"2"},"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}
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":"4 1","pages":""},"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}
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
{"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":"3 ","pages":"9"},"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}