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.

Added prognostic value of Doppler ultrasound for adverse perinatal outcomes: A pooled analysis of three cohort studies.

BACKGROUND: Fetal growth restriction (FGR) is an obstetric complication associated with adverse perinatal outcomes. Doppler ultrasound can improve perinatal outcomes through monitoring at-risk fetuses and helping time delivery. AIM: To investigate the prognostic value of different Doppler ultrasound measurements for adverse perinatal outcomes. MATERIALS: Individual participant data. METHODS: We performed a pooled analysis on individual participant data. We compared six prognostic models using multilevel logistic regression, where each subsequent model added a new variable to a base model that included maternal characteristics. Estimated fetal weight (EFW) and four Doppler ultrasound measurements were added in turn: umbilical artery pulsatility index (UA PI), middle cerebral artery pulsatility index (MCA PI), cerebroplacental ratio (CPR), and mean uterine artery pulsatility index (mUtA PI). The primary outcome was a composite adverse perinatal outcome, defined as perinatal mortality, emergency caesarean delivery for fetal distress, or neonatal admission. Discriminative ability was quantified with area under the curve (AUC). RESULTS: Three data sets (N = 3284) were included. Overall, the model that included EFW and UA PI improved AUC from 0.650 (95% CI 0.624-0.676) to 0.673 (95% CI 0.646-0.700). Adding more ultrasound measurements did not improve further the discriminative ability. In subgroup analysis, the addition of EFW and UA PI improved AUC in both preterm (AUC from 0.711 to 0.795) and small for gestational age pregnancies (AUC from 0.729 to 0.770), but they did not improve the models in term delivery or normal growth subgroups. CONCLUSIONS: Umbilical artery pulsatility index added prognostic value for adverse perinatal outcomes to the already available information, but the combination of other Doppler ultrasound measurements (MCA PI, CPR or UtA PI) did not improve further prognostic performance.

Correlation of continence with long-term patient centered outcomes in children with sacrococcygeal teratoma.

PURPOSE: The purpose of this study is to evaluate the relationship of social continence with patient centered outcomes, such as quality of life, in children with sarococcygeal teratoma (SCT). We hypothesize there is a correlation between social continence and patient-centered outcomes. METHODS: A chart review and three surveys (Pediatric Quality of Life Inventory™ (PedsQL™), Baylor Continence Scale (BCS), and Impact on Family (IOF)) were performed for SCT patients who underwent resection at our institution from 2013 to 2018. PedsQL™ assesses quality of life, BCS evaluates global continence, and the IOF scale measures the impact of a child's illness on the family. Pearson correlation was used to examine the relationship between BCS, PedsQL™, and IOF. RESULTS: Eighteen patients were identified with 72% (13/18) participating in the surveys with a median age at time of survey of 4.7 years (range 2.8-7.9). Patients with Altman IV were diagnosed postnatally and had smaller tumors. At the time of survey administration, a majority of children were toilet trained (54%, 7/13). Parents reported urinary incontinence (46%, 6/13) more frequently than bowel incontinence (15%, 2/13). Altman III/IV trended towards worse PedsQL™, BCS, and IOF surveys; however, it was not significant. The BCS correlated with the Total PedsQL™ (ρ = -0.56, p = 0.048) and IOF (ρ = 0.68, p = 0.011). CONCLUSION: Children with SCT have a correlation between social continence, quality of life, and the impact on family. This study suggests interventions to screen and improve continence in children with SCT could also improve patient centered metrics. STUDY DESIGN: Cross-sectional study LEVEL OF EVIDENCE: Level II, Prognosis Study.