Your “clinical trial” from submission to decision

In this brief report I am going to give the reader some tips on how the editorial office of the Saudi J Anesthesia (SJA) handle your clinical trial paper once received. Before sending your paper to any journal make sure you read the instruction to authors and follow the mentioned guidelines. Initial screening (desk check): Cover letter: this is the first to investigate. Most of the researchers do not give much attention to it. However, the cover letter should be written carefully with reasoning why you send this paper to the journal with brief on the paper contents. Mind you your paper could be rejected just because the cover letter was not focused and contain wrong information. For example, happen frequently, that the author mention in it different title, most likely the author sends it before to another journal and forget to update it sending to the target one. Also, wrong journal name/EIC. Declaration using large language model (LLM): most of the journals require this declaration to be included in the cover letter. Recently, more than fifty Editors-in-Chief of anesthesiology and pain medicine journals, or their delegates, participated in a Delphi consensus process to define the limits, possibilities, and opportunities that large language models (LLM) pose to the academic ecosystem in a project called RULE-AP and published in the British Journal of Anesthesia1—to which we proudly contributed as the Saudi J of Anesthesia. The core message of this consensus is acknowledging both the undeniable benefits of LLMs, including improved efficiency, linguistic support, and reduced cognitive burden for editors, reviewers, authors, and publishers, but it also highlights the substantial risks they pose when used indiscriminately or without disclosure. Hallucinated content, fabricated references, erosion of critical thinking, and threats to confidentiality are not hypothetical concerns; they are real challenges already encountered in daily editorial practice. Using AI tools to prepare or refine a manuscript is not necessarily unethical, but most journals ask that this is disclosed; otherwise, it could hint that the technology was used inappropriately in other parts of the paper.2 ChatGPT zero is software available in most of journals to check AI use. In SJA we have updated the instruction to authors section by adding a statement that upon paper submission the author has to declare use of LLM in the cover letter to the editor otherwise it will be considered as violation of the journal policy. Title and abstract: title should be short, focused including the population, intervention, comparator, and outcome (PICO format).3 Abstract is the first part to read by the editor. The editor can get a good sense of the quality of the paper from just the abstract. A nice, tightly written abstract is an obvious thing. Abstracts that are overblown, unclear, very long or that describe findings that are implausible or uninteresting can signal a low-quality paper. Check methods section: specially in clinical trials (study on subjects) the editors investigate the research integrity parameters. Mainly the ethical issues. Institute research board approval (IRB) and online registration of the clinical trial. Demographic data of subjects clearly written. Mind you most of articles rejected due to flaws in the given demographic data. We investigate whether CONSORT flow chart was given or not. Also, in the methods section we check sample size calculation and the appropriateness of the statistical test used for the given data. In SJA we have statisticians as section editors for consultation. Check plagiarism: since 2016 in SJA all incoming manuscripts routinely undergo a similarity check using the iThenticate CrossCheck service that has been integrated into Editorial Manager. The similarity check has been implemented to run in the background for each new submitted manuscript and each revised submission. Obviously, bibliographic references and quotations are excluded. Thus, upon first inspection of a new or revised manuscript, editors will automatically see a percentage figure indicating the sum of all text similarities with other published academic literature. If the percentage is alarmingly high, editors can assess a “match overview” consisting of a list of source materials together with the color highlighted matching text sections, each given with a percentage figure and the absolute number of identical words. Editors then must take a value judgement: plagiary or not. The paper is either sent for peer review or receives a “desk rejection” if it does not meet the journal’s standards. Cycling of the paper: assign section editor: we have section editors to each anesthesia subspecialties. The article will be assigned to section editor who is going to select the reviewers. selection of reviewers: will be either from list of referees suggested by the author (less likely), PubMed, personal contact or from the journal data base (most likely). In our data base we have around 1,300 reviewers. The reviewing process takes 2–3 weeks. Sometimes takes longer due to delay in the reviewer’s response. reviewers’ response: will be either accept as it is, minor/major revision or reject. Minor revision like language typos, tables/figures design where major revision includes, inappropriate statistical analysis, backdated references, missing IRB, and/or online registration. Whether minor or major revision its usually good news for you that the paper substantially will be accepted based on your response to the reviewers’ comments. revision and rebuttal letter: provide an overview, then quote the full set of reviews and answer each point mentioned by the reviewers. Be polite and respectful of all reviewers. Accept the blame. Show appreciation for reviewer’s feedback. Thank reviewers and appreciate their time and insights. re-review: the article then goes back to the original reviewers for assessment and decision either to accept the author response or back for more revisions. Then back to the section editor/EIC for final decision. In summary and to have good research follow this roadmap: Follow “Helsinki Declaration” in human research/IRB/ClinTrials registration. Follow guidelines for each study design. Honesty/transparency in all scientific communications. Select the journal to publish even before starting data collection. Follow instruction to authors of target journal. Avoid Plagiarism/fabrication/falsification/duplicate submission. Consult statistician before beginning data collection/sample size calculation. Carefully and critically examine your own work with attention to language/grammar. Keep records of research activities, such as data collection. Answer reviewers carefully and politely. “Editors/Reviewers are the gatekeepers of the scientific work. The readers rely on them to ensure the novelty and integrity of the published material”.