Background: Randomized clinical trials (RCTs) are experiencing a crisis of confidence in their trustworthiness. Although a comprehensive literature search yielded several reviews on RCT integrity, an overarching overview is lacking.Objectives: The authors undertook a scoping umbrella review of the research integrity literature concerning RCTs.Search strategy and selection criteria: Following prospective registration (https://osf.io/3ursn), two reviewers independently searched PubMed, Scopus, The Cochrane Library, and Google Scholar, without language or time restrictions, until November 2021. The authors included systematic reviews covering any aspect of research integrity throughout the RCT lifecycle.Data collection and analysis: The authors assessed methodological quality using a modified AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews) tool and collated the main findings.Main results: A total of 55 relevant reviews, summarizing 6001 studies (median per review, 63; range, 8–1106) from 1964 to 2021, had an overall critically low quality of 96% (53 reviews). Topics covered included general aspects (15%), design and approval (22%), conduct and monitoring (11%), reporting (38%), postpublication concerns (2%), and future research (13%). The most common integrity issues covered were ethics (18%) and transparency (18%).Conclusions: Low‐quality reviews identified various integrity issues across the RCT lifecycle, emphasizing the importance of high ethical standards and professionalism while highlighting gaps in the integrity landscape. Multistakeholder consensus is needed to develop specific RCT integrity standards.
1 October 1997 in BJOG: An International Journal of Obstetrics & Gynaecology
The integrity of randomized clinical trials (RCT) has become a concern owing to a recent rise in the number of retractions and the repercussions this has for evidence‐based patient care. However, there is little research on the subject of RCT integrity assessment. Recent literature reviews have revealed that journals' authors' instructions concerning integrity and their investigation policies concerning allegations of misconduct are heterogeneous. The judicious use of integrity tests applied to RCT manuscripts is hampered by an absence of data concerning misconduct prevalence (pre‐test probability), a failure to evaluate test performance (validity) and a lack of consensus over a gold standard (against which test accuracy can be evaluated). These deficiencies hinder the post‐publication correction of RCT records, the integrity evaluations in systematic reviews of RCTs and the prospective application of preventive solutions in RCT peer‐review and preprint assessment. Dealing with the current controversy about trustworthiness of RCT evidence requires a strong investment in research, reform and education concerning research integrity. The purpose of this review article is to highlight the current limitations in dealing with trial integrity‐related concerns and to propose solutions to some of these issues.
3 April 2024 in International Journal of Gynecology & Obstetrics
Systematic reviews rank at the top of the evidence hierarchy. Concise writing implies drafting the systematic review article succinctly, i.e. using as few words to express as full an extent of the research effort as possible. Precise writing means drafting the text with accuracy especially with respect to the methodological and statistical aspects. The Abstract ought to be succinct and structured to allow for editors, peer reviewers and readers to get the gist of the key aspects of the systematic review with a quick read. The readership needs to be able to critically appraisal systematic reviews for their internal and external validity rapidly. The Abstract also needs to be standalone, representing an independent summary that can be fully understood without the need for reading the full paper. The standard structure of the main text of a scientific article called IMRaD (Introduction, Methods, Results and Discussion) applies equally to systematic reviews in the same way as it does to any other kinds of research manuscripts whether related to laboratory experiments or clinical trials. Restricting the word count limits to those imposed by journals may at first seem difficult, even unfair, to systematic reviewers. However, with the availability of online appendices to transparently and fully report the details of the methods, results and other aspects of the work undertaken allows for a succinct print or PDF article. Writing a shorter manuscript is more effortful than writing a longer report. This commentary is aimed at novice systematic reviewers to help them learn the written and unwritten writing rules in order to assist them in producing impactful publications to support evidence-based medicine. doi: https://doi.org/10.12669/pjms.39.2.7428 How to cite this: Chien PFW, Khan KS. Systematic Review Reporting - Writing concisely and precisely. Pak J Med Sci. 2023;39(2):317-322. doi: https://doi.org/10.12669/pjms.39.2.7428 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
13 August 2025 in International Journal of Gynecology & Obstetrics