Improving trustworthiness in research in women's health: A collective effort by OBGYN editors

Abstract

Overall, more than 1.7 million entries were added to PubMed in 2022. Over 35 000 Obstetrics articles alone have been added per year since 2020, with that number reaching over 40 000 in 2021 and 2022.1 As the volume of published medical research articles continues to expand, so too do the occurrences of errors and outright research and publication misconduct. It is important for all stakeholders in medical research to take an active role in identifying possible errors, misconduct, and manipulation of the publication process. An ad hoc group of editors of journals related to obstetrics, gynecology, women's health, and related topics are collectively focusing on the problem of manuscripts with flawed or fabricated data, or other types of misconduct. Although our initial focus is on randomized controlled trials and systematic reviews with or without meta-analysis, the principles apply across methodologies. We aim to improve the trustworthiness of published data in research in women's health with the processes we describe herein. Current clinical guidance relies heavily on randomized controlled trials (RCTs) and meta-analyses of RCTs, often considered the pinnacle of evidence-based medicine. These studies are used to determine treatment and follow-up protocols, and they are frequently included in national and international guidelines.2, 3 However, if the data in these RCTs and meta-analyses of RCTs are untrustworthy, medical decisions based on them can lead to patient harm. Costs to the research enterprise include wasted effort to replicate results; chasing flawed hypotheses; closing lines of inquiry if the answer is considered “known”; an individual's career aspirations; and journal resources.4 To improve the reliability of data in RCTs and meta-analyses of RCTs, two paths can be taken: prevention of publication of flawed studies in the first place, and retrospective identification of untrustworthy data with post-publication correction of the literature. There have been several separate strategies proposed to prevent the publication of flawed RCTs and systematic reviews.5-16 We have agreed to implement a bundle of strategies17 which will be required upon submission to our journals (Table 1). Non-adherence to these criteria will result in rejection. Those who perform systematic reviews and meta-analyses of RCTs are also called upon to ensure that the included RCTs are free of falsified data by asking the investigators for documents or datasets that can verify the authenticity of the data. The global view of protecting the obstetrics and gynecology literature from publishing flawed research requires communication among editors. This must be balanced by respect for the authors and an “innocent until proven guilty” mindset. Even so, we know that authors, once rejected by one journal, will usually submit to another. Present general practice prevents editors from communicating with each other about suspected misconduct in a manuscript. However, COPE guidelines support communication between editors when it is necessary for the Editor-in-Chief to fulfill their obligation to “respond to suspected research misconduct”.24 Such communication will need to be transparent, factual, and respectful. Our group is investigating methods to allow for such communications, compliant with COPE guidelines. We will continue to require that potentially publishable submissions be screened using software to identify evidence of plagiarism and text-recycling. To identify untrustworthy data in studies that have previously been published in our journals, editors will consider all post-publication allegations of misconduct. Credible allegations relating to articles published within the previous 5 years will always be fully investigated. Investigations of this type are best done by examining the primary data sets on which the paper is based. It is at the discretion of the editor whether to investigate allegations about papers published before this timeframe. The steps agreed upon are outlined in Box 1, and are based upon the COPE guidance for handling cases of suspected data fabrication.18 They involve contacting the authors and their institutions to ask for clarifications, with suggested deadlines for each step, to facilitate a timely investigation process (Figure 1). While COPE's guidelines are non-specific regarding the timeliness of these investigations and editorial actions, we have agreed upon a schedule for completion of these steps. Providing data: Where concerns raised are judged to be serious, editors will request that the raw data for the study are provided for review. It is acknowledged that in cases where several years have elapsed since the study, there may be challenges to accessing raw data—this consideration will be taken into account during review of these cases; however, inability to provide raw data will not preclude the possibility of retraction or publication of an Expression of Concern. Author/institution response time: The following timeframes are suggested: When concerns are raised, journals will initially contact all authorsa of manuscripts, allowing 4 weeks for initial acknowledgment. If no response is received from authors, the authors’ institution(s) will then be contacted, with a 4-week timeframe for response. Also, the journal can issue an Expression of Concern (EoC). An EoC is “used to raise awareness to a possible problem in an article”.25 Editors will allow 6 months for a full investigation after receipt of acknowledgement of the notification of concerns by the authors and/or institution. It is not necessary for a journal editor to await results of institutional investigations to proceed with issuing an Expression of Concern, correction, or retraction if their own investigation is conclusive. *Clear communication: Authors and institutions are aware throughout each journal’s Instructions to Authors that failure to respond/unsatisfactory response to concerns will result in retraction. *Linkage: Expressions of Concern and retraction notices will be linked to articles in PubMed, on the journal website, on the publisher website, etc. These corrective statements will not be behind a paywall.26 aCo-authors will be contacted where their contact details have been provided, or where these are readily available (e.g., through Internet search). Apart from these steps, several journals have appointed research integrity or trustworthiness editors, or committees, who work to improve the submission, review, and editorial processes so that only studies with true and reliable data are published. All journals will continue to update their author guidelines to reflect the agreed-upon changes. Journals are invited to join this initiative, and feedback from authors and readers is welcome. Most authors and institutions perform honest, reliable, and reproducible research. The concern of this editorial is focused on intentional falsification of data, and not on honest mistakes or errors and other types of misconduct. In 2019, the editors of the European Journal of Clinical Investigation stated “As a linchpin in maintaining the quality of the scientific literature, those involved in the editorial process have a duty to redouble their commitment for fulfilling the ideals of science as a self-correcting process”.19 With this editorial, we state our aspiration to provide the scientific community with dependable, trustworthy data to base clinical decision-making on. We are united in our efforts in this battle and welcome your input. American Journal of Obstetrics & Gynecology MFM. International Journal of Gynecology and Obstetrics. BJOG: An International Journal of Obstetrics and Gynaecology. Reproductive, Female and Child Health. Ultrasound in Obstetrics and Gynecology. European Journal of Obstetrics and Gynecology. Australian and New Zealand Journal of Obstetrics and Gynecology. American Journal of Perinatology. Gynecologic and Obstetric Investigation. Data sharing not applicable to this article, as no datasets were generated or analysed during the current study.

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