Concerns about data integrity across 263 papers by one author.

OBJECTIVE: Comprehensive investigation of published work by authors suspected of academic misconduct can reveal further concerns. We aimed to test for data integrity concerns in papers published by an author with eight retracted articles. STUDY DESIGN: We investigated the integrity of all papers reporting on prospective clinical studies by this author. We assessed the feasibility of study methods, baseline characteristics, and outcomes. We plotted the author's clinical research activity over time. We conducted pairwise comparisons of text, tables, and figures to identify duplicate publications, and checked for consistency between conference abstracts, interim analyses, trial registrations, and final papers. Where indicated, we recalculated p-values from the reported summary statistics. RESULTS: We identified 263 papers claiming to have enrolled 74,667 participants between January 2009 and July 2022, 190 (72%) of which reported on studies that recruited from the Assiut Women's Health Hospital in Assiut, Egypt. The number of active studies per month was greatest between 2016 and 2019, with 88 ongoing studies in May 2017. We found evidence of data integrity concerns in 130 (49%) papers, 43 (33%) of which contained concerns sufficient to suggest that they could not be based on data reliably collected from human participants. CONCLUSION: Our investigation finds evidence of widespread integrity concerns in the collected work of one author. We recommend that the involved journals collaborate in a formal investigation.

Randomised controlled trials in women's health in the last two decades: A meta-review.

OBJECTIVES: Obstetric and gynaecological conditions represent a significant burden of disease, requiring clinical research. We aimed to study trends in the publication of randomised controlled trials (RCTs) in women's health over the last two decades. The primary objective was to describe longitudinal trends in the geographical distribution of RCTs in obstetrics and gynaecology. We also described trends in trial funding, publication sources and separately published trial protocols. STUDY DESIGN: RCTs were identified by searching the Web of Science alone, due to the large number of results and descriptive nature of analyses. Using the filter tool, only studies labelled as "Clinical trial" or "Article" were included; all other document types were excluded. Trial protocols were identified and analysed separately. Indexing data were extracted using the Web of Science selection tools. As we aimed simply to describe research trends using a single platform, we did not check for duplicates. No process for data pooling was necessary. Correlation of GDP, funding and number of RCTs was calculated using Pearson's r test. RESULTS: We identified 39,071 RCTs. The number of annual publications globally increased from 1,406 in 2001 to 1,979 in 2020. The US (n = 12,479) and the UK (n = 3,745) were responsible for the most RCTs, followed by Italy (n = 2,676) and China (n = 2,338). The largest percentage increase in annual publications was seen in Iran (n = 5 to n = 113, +2,160 %) and the Western Pacific Region (n = 16 to n = 171, +968.8 %). GDP was significantly correlated with the number of published RCTs in 2019 for the 25 most prolific countries (p < 0.001), but not with the proportion of RCTs funded. CONCLUSIONS: Despite growing contributions from the Western Pacific and Eastern Mediterranean regions, most RCTs are still produced in a small nucleus of high-income countries. Increased international collaboration may benefit both high- and low-income countries.

An Administrative Data-based Surrogate Definition Identifies Children Evaluated Beyond Physical Examination for Suspected Appendicitis.

Previous studies have reported on the evaluation of patients diagnosed with appendicitis. Very little is known about all patients evaluated for suspected appendicitis. Patients evaluated beyond physical examination with laboratory and imaging testing, then found not to have appendicitis, are more difficult to identify. Data readily available in administrative databases may be used to identify these patients. METHODS: A multidisciplinary team developed a surrogate definition for evaluating suspected appendicitis in children based on available administrative data. Appendicitis was "suspected" if the patient underwent ultrasonography of the appendix or had a chief complaint of abdominal pain with both complete blood count performed and the word "appendicitis" in the ED provider note. Performance characteristics described the surrogate definition's ability to retrospectively identify patients evaluated for suspected appendicitis through comparison to a population identified via chart review. RESULTS: Compared with manual chart review of 498 patients from June 2014, the surrogate definition identified patients evaluated beyond physical examination for suspected appendicitis with a sensitivity of 79.8%, a specificity of 96.3%, a positive predictive value of 83.3%, and a negative predictive value of 95.3%. Of the 94 patients evaluated beyond physical examination for suspected appendicitis, 37 (39%) underwent appendectomy. CONCLUSIONS: Health systems can retrospectively identify children evaluated beyond physical examination for appendicitis using discrete administrative data and a word search of clinical notes. This surrogate definition for evaluation of suspected appendicitis enables research in quality improvement efforts and health care resource utilization.