Participant Data Research Articles

Molecular Triggers of Non-Celiac Wheat Sensitivity: A Scoping Review and Analysis

BACKGROUND & AIMS: Non-celiac wheat sensitivity (NCWS) is characterized by symptomatic response to the ingestion of foods containing wheat and related cereal grains in the absence of celiac disease or wheat allergy. Despite efforts to identify the constituent component(s) of wheat responsible for triggering NCWS, no consensus has emerged, leading to competing claims. We aimed to systematically evaluate the literature and provide an evidence-based conclusion on the contribution of specific wheat components to NCWS. METHODS: A comprehensive search of multiple bibliographic databases was conducted, focusing on primary research. Data were systematically analyzed, and methodological gaps were identified. RESULTS: The search identified 175 unique citations, revealing three categories of compounds frequently considered as potential triggers of NCWS: gluten, fermentable carbohydrates, and amylase/trypsin inhibitors (ATIs). Among 16 double-blind placebo-controlled studies, eight reported a greater symptomatic response to gluten than the control. Only one controlled study examined fermentable carbohydrates, finding a modest effect, but the tested carbohydrates were not derived from wheat. No eligible studies assessed ATIs or other wheat-related compounds as potential NCWS triggers. Across studies, significant limitations and methodological inconsistencies were noted, particularly in participant selection, challenge protocols, and data reporting. Conclusion: Gluten is the most extensively investigated wheat component linked to NCWS, but evidence for its role is inconsistent and undermined by methodological limitations. No direct evidence currently links wheat fermentable carbohydrates, ATIs, or other components to NCWS symptoms. The existing evidence is insufficient to justify restricting specific components of wheat in the management of NCWS. Future studies must overcome the identified gaps to rigorously investigate the role of wheat and related cereals in NCWS, with the potential to advance diagnosis and treatment.

Autonomic cardiac control independently predicts incident hypertension and systolic blood pressure in a multi-ethnic population: The HELIUS study

Abstract Aims Cross-correlation baroreflex sensitivity (xBRS) and heart rate variability (HRV) are measures of autonomic cardiac control and are associated with hypertension. However, their value in predicting new-onset hypertension and changes in systolic blood pressure (SBP) remains elusive. Methods We used longitudinal data of participants with- and without a history of cardiovascular disease from the HEalthy Life In an Urban Setting (HELIUS) study. A non-invasive continuous finger blood pressure measurement at baseline was used to calculate xBRS and HRV. In normotensives at baseline we calculated the odds ratio (OR) of developing hypertension at follow-up. In the full cohort we assessed the change in SBP between baseline and follow-up using linear regression. Subgroup analyses were performed in the younger (<50 years) and older (≥50 years) participants. Results Median follow-up was 6.6 years (IQR 5.8-7.4). A 50% lower xBRS at baseline was independently associated with a 1.31 higher OR (95% CI 1.09–1.57) of developing hypertension at follow-up. No significant associations between the standard deviation normal-to-normal interval (SDNN) or the root mean square of differences in successive normal-to-normal interval (RMSDD), and new-onset hypertension were found. Compared to the lowest tertile, an xBRS in the highest tertile was associated with a 3.61 mmHg (95%CI 2.50-4.71) higher increase in SBP over time, whereas this was 1.11 mmHg (95%CI 0.12-2.09) and 1.76 mmHg (95%CI 0.73-2.79) for SDNN and RMSDD. Conclusion In the general population, a lower xBRS is associated with increased odds of developing hypertension, and a steeper increase in SBP over time.

Building a Digital Health Research Platform to Enable Recruitment, Enrollment, Data Collection, and Follow-Up for a Highly Diverse Longitudinal US Cohort of 1 Million People in the All of Us Research Program: Design and Implementation Study

Background Longitudinal cohort studies have traditionally relied on clinic-based recruitment models, which limit cohort diversity and the generalizability of research outcomes. Digital research platforms can be used to increase participant access, improve study engagement, streamline data collection, and increase data quality; however, the efficacy and sustainability of digitally enabled studies rely heavily on the design, implementation, and management of the digital platform being used. Objective We sought to design and build a secure, privacy-preserving, validated, participant-centric digital health research platform (DHRP) to recruit and enroll participants, collect multimodal data, and engage participants from diverse backgrounds in the National Institutes of Health’s (NIH) All of Us Research Program (AOU). AOU is an ongoing national, multiyear study aimed to build a research cohort of 1 million participants that reflects the diversity of the United States, including minority, health-disparate, and other populations underrepresented in biomedical research (UBR). Methods We collaborated with community members, health care provider organizations (HPOs), and NIH leadership to design, build, and validate a secure, feature-rich digital platform to facilitate multisite, hybrid, and remote study participation and multimodal data collection in AOU. Participants were recruited by in-person, print, and online digital campaigns. Participants securely accessed the DHRP via web and mobile apps, either independently or with research staff support. The participant-facing tool facilitated electronic informed consent (eConsent), multisource data collection (eg, surveys, genomic results, wearables, and electronic health records [EHRs]), and ongoing participant engagement. We also built tools for research staff to conduct remote participant support, study workflow management, participant tracking, data analytics, data harmonization, and data management. Results We built a secure, participant-centric DHRP with engaging functionality used to recruit, engage, and collect data from 705,719 diverse participants throughout the United States. As of April 2024, 87% (n=613,976) of the participants enrolled via the platform were from UBR groups, including racial and ethnic minorities (n=282,429, 46%), rural dwelling individuals (n=49,118, 8%), those over the age of 65 years (n=190,333, 31%), and individuals with low socioeconomic status (n=122,795, 20%). Conclusions We built a participant-centric digital platform with tools to enable engagement with individuals from different racial, ethnic, and socioeconomic backgrounds and other UBR groups. This DHRP demonstrated successful use among diverse participants. These findings could be used as best practices for the effective use of digital platforms to build and sustain cohorts of various study designs and increase engagement with diverse populations in health research.

The neural basis of event segmentation: Stable features in the environment are reflected by neural states

Abstract Our senses receive a continuous stream of complex information. Parsing this information into meaningful events allows us to extract relevant information, remember it, and act upon it. Previous research has related these events to so-called neural states: temporally and regionally specific stable patterns of brain activity, which tend to coincide with events in the stimulus. Neural states show a temporal cortical hierarchy: short states are present in early sensory areas, while longer states can be found in higher-level areas. Here we investigated what these neural states represent. We hypothesized that states at different levels of the cortical hierarchy are shaped by aspects of the stimulus to which these brain areas are responsive. To test this hypothesis, we analyzed fMRI data of participants watching a movie, using a data-driven method to identify the neural states. We found support for the aforementioned hypothesis: specifically the parahippocampal place area and retrosplenial cortex, known to be sensitive to places, showed an alignment between neural state boundaries and moments in the movie with a change in location, independent of changes in visual features and other covariates. These findings suggest that neural states reflect stable features in the (internal model of) the external environment, and that the cortical temporal hierarchy partly reflects the temporal scales at which representations of the environment evolve.

An Individual Participant Data Meta-Analysis to Support Power Analyses for Randomized Intervention Studies in Preschool: Cognitive and Socio-Emotional Learning Outcomes

There is a need for robust evidence about which educational interventions work in preschool to foster children’s cognitive and socio-emotional learning (SEL) outcomes. Lab-based individually randomized experiments can develop and refine such interventions, and field-based randomized experiments (e.g., cluster randomized trials) evaluate their effectiveness in real-world daycare center settings. Applying reliable estimates of design parameters in the context of a priori power analyses is essential to ensure that the sample size of these studies is adequate to support strong statistical conclusions regarding the strength of the intervention effect. However, there is little knowledge on relevant design parameters with preschool children. We therefore utilized a systematic collection of individual participant data from four German probability samples (554 ≤ N ≤ 2928) with preschool children (aged two to six years) to estimate and meta-analyze design parameters. These parameters are relevant for planning single-level (e.g., in non-clustered lab-based settings), two-level (children nested in daycare centers), and three-level (children nested in groups, with groups nested in daycare centers) randomized intervention studies targeting cognitive and SEL outcomes assessed with three methods (standardized tests, parent ratings, and educator ratings). The design parameters depict between-group and -center differences as well as the proportion of variance in the outcomes explained by different covariate sets (socio-demographic characteristics, baseline measures, and their combination) at the child, group, and center level. In conclusion, this paper provides a rich source of design parameters, recommendations, and illustrations to support a priori power analyses for randomized intervention studies in early childhood education research.

Decentralized clinical trials are better for the participants and for the planet: the case study of a double-blind randomized controlled trial in Singapore (PROMOTE study)

IntroductionNovel technologies have enabled the decentralization of many aspects of clinical trials, but little research has been done on the impact of these changes on the participant experience, trial operations, or the environment.MethodsA fully decentralized clinical trial conducted in Singapore is used as a case study to evaluate the operational outcomes, environmental impact (via life cycle assessment), and participants experience (qualitative interviews) of the decentralized model compared to a traditional study with in-person visits.ResultsThe decentralized study achieved high participant retention rates (97%) and high completion rates for clinical data, even for biological samples. Participants found the decentralized model to be convenient and safe, especially during the pandemic. Moreover, the decentralized model was found to be more environmentally friendly and less detrimental to human health compared to traditional face-to-face clinical trials, primarily by reducing participants’ use of cars for site visits.DiscussionWhile this study focused on the environmental impact, it is important to consider other factors such as participant safety, convenience, and data quality when evaluating the suitability of a decentralized clinical trial approach. Careful planning of data flow, database structure, and data protection measures is essential. This study contributes to improving the environmental footprint of clinical trials. Environmental sustainability should be among the factors that are evaluated when selecting trial models. Decentralized and hybrid clinical trials offer efficiency, effectiveness, and environmental benefits. Further research and adoption of these approaches are encouraged.

Implementation of a genotyped African population cohort, with virtual follow-up: A feasibility study in the Western Cape Province, South Africa

Background There is limited knowledge regarding African genetic drivers of disease due to prohibitive costs of large-scale genomic research in Africa. Methods We piloted a scalable virtual genotyped cohort in South Africa that was affordable in this resource-limited context, cost-effective, scalable virtual genotyped cohort in South Africa, with participant recruitment using a tiered informed consent model and DNA collection by buccal swab. Genotype data was generated using the H3Africa Illumina micro-array, and phenotype data was derived from routine health data of participants. We demonstrated feasibility of nested case control genome wide association studies using these data for phenotypes type 2 diabetes mellitus (T2DM) and severe COVID-19. Results 2267346 variants were analysed in 459 participant samples, of which 229 (66.8%) are female. 78.6% of SNPs and 74% of samples passed quality control (QC). Principal component analysis showed extensive ancestry admixture in study participants. Of the 343 samples that passed QC, 93 participants had T2DM and 63 had severe COVID-19. For 1780 previously published COVID-19-associated variants, 3 SNPs in the pre-imputation data and 23 SNPS in the imputed data were significantly associated with severe COVID-19 cases compared to controls (p<0.05). For 2755 published T2DM associated variants, 69 SNPs in the pre-imputation data and 419 SNPs in the imputed data were significantly associated with T2DM cases when compared to controls (p<0.05). Conclusions The results shown here are illustrative of what will be possible as the cohort expands in the future. Here we demonstrate the feasibility of this approach, recognising that the findings presented here are preliminary and require further validation once we have a sufficient sample size to improve statistical significance of findings. We implemented a genotyped population cohort with virtual follow up data in a resource-constrained African environment, demonstrating feasibility for scale up and novel health discoveries through nested case-control studies.

Correction: Filtration Markers as Predictors of ESRD and Mortality: Individual Participant Data Meta-Analysis.

Correction: Filtration Markers as Predictors of ESRD and Mortality: Individual Participant Data Meta-Analysis.

Assessing Water Content of the Human Colonic Chyme Using the MRI Parameter T1: A Key Biomarker of Colonic Function.

The human colon receives 2 L of fluid daily. Small changes in the efficacy of absorption can lead to altered stool consistency with diarrhea or constipation. Drugs and formulations can also alter colonic water, which can be assessed using the magnetic resonance imaging (MRI) longitudinal relaxation time constant, T1. We explore the use of regional T1 assessment in evaluating disorders of colonic function. Individual participant data analysis of data from 12 studies from a single center of patients with constipation, irritable bowel syndrome with diarrhea (IBS-D), and healthy volunteers (HV). T1 was quantified by measuring the signal from the tissue at different times after a pulse which inverts the magnetization. When diarrhea was induced by a macrogol laxative T1 in the ascending colon, T1AC was negatively correlated with stool bacterial content, r2 = 0.78, p < 0.001. T1AC was increased by another laxative, rhubarb. Patients with IBS-D had elevated fasting T1AC (0.78 ± 0.28 s, N = 67) compared to HV (0.62 ± 0.21 s, N = 92) while those with constipation lay within the normal range (HV 10-90th centiles 0.33-0.91 s). Fasting T1AC in IBS-D was reduced by mesalazine treatment. T1 in the descending colon was consistently lower than T1AC, with a bigger reduction in patients with constipation than HV. Pre-feeding dietary fiber (bran, nopal, and psyllium) was associated with fasting T1AC at or above the normal 90th centile. T1 is an MRI parameter which could be used to monitor effectiveness of novel agents designed to alter colonic water content and stool consistency.

“Part of the world again”: qualitative enquiry into community participation during inpatient rehabilitation and transition years following severe brain injury

ABSTRACT Purpose To understand the experience of community and social participation for people with severe ABI during inpatient rehabilitation and the transition years. Methods Constructivist grounded theory methodology informed participant recruitment and data analysis. Adults with ABI were recruited using purposive sampling and data collected via in-depth interviews. Results Thirteen adults with severe ABI participated, with average age of 36.7 yrs at the time of injury, 9.1 months length of stay of in inpatient rehabilitation, and 4 years post discharge from hospital at time of interviews. The core category developed from thematic analysis was ‘lack of focus on community and social participation.’ Additional categories included: restricted participation, a focus on impairment and function, acceptance and connection within the community, influence of family and delayed return to community participation. Conclusion Community and social participation are recognized as the goal of rehabilitation following ABI; however, experiences shared by participants revealed that community and social participation were not the focus of their rehabilitation. Implications for rehabilitation To support positive holistic outcomes, focus on community and social participation is required within the rehabilitation continuum, using participatory frameworks, contextual goal setting, transparent endorsement for community access and the provision of opportunities for meaningful experiences with family and friends.

Cardiovascular, kidney and safety outcomes with canagliflozin in older adults: A combined analysis from the CANVAS Program and CREDENCE trial.

SGLT2 inhibitors may be underused in older adults with type 2 diabetes due to concerns about safety and tolerability. This pooled analysis of the CANVAS Program and CREDENCE trial examined the efficacy and safety of canagliflozin according to age. Pooled individual participant data from the CANVAS Program (n = 10 142) and CREDENCE trial (n = 4401) were analysed by baseline age (<65 years, 65 to <75 years, and ≥75 years). A range of adjudicated clinical outcomes were assessed, including major adverse cardiovascular events and CKD progression, as well as safety outcomes. Cox proportional hazards models and Fine and Gray competing risk analysis were used. Among the 14 543 participants, 7927 (54.5%) were <65 years, 5281 (36.3%) were 65 to <75 years and 1335 (9.2%) were ≥75 years. Older participants had higher rates of atherosclerotic cardiovascular disease and heart failure, longer diabetes duration and lower mean eGFR. Reductions in cardiovascular and kidney outcomes with canagliflozin were consistent across age categories (all p trend >0.10), although there was some evidence that effects on cardiovascular death and all-cause death were attenuated with older age (p trend = 0.02 and 0.03, respectively). Although the incidence of adverse events increased with age, effects of canagliflozin on safety outcomes including acute kidney injury, volume depletion, urinary tract infections and hypoglycaemia, were not modified by age (all p trend >0.10). In patients with varying degrees of kidney function, canagliflozin reduced cardiovascular and kidney outcomes, regardless of age, with no additional safety concerns identified in older patients.

Systematic Review and Meta-Analysis of Individual Participant Data: Randomized, Placebo-Controlled Trials of Selective Serotonin Reuptake Inhibitors for Pediatric Obsessive-Compulsive Disorder.

Selective serotonin reuptake inhibitors (SSRIs) are the first choice in pharmacotherapy for children and adolescents with obsessive-compulsive disorder (OCD). SSRI-trials for pediatric OCD have never been investigated using individual participant data (IPD), which is crucial for detecting patient-level effect modifiers. Here, we performed an IPD meta-analysis on the efficacy of SSRIs compared to placebo, and a meta-regression on baseline patient characteristics which might modify efficacy. We used crude participant data from short-term, randomized, placebo-controlled SSRI trials for pediatric OCD, available from the registry of the Dutch regulatory authority. We also performed a systematic literature search and approached the authors to provide IPD. We performed a one- and two-stage analysis, with change on the Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS) as the primary outcome. We used Odds Ratio (OR) with ≥ 35% CY-BOCS-reduction as the responder outcome measure. We examined modifying effect of age, sex, weight, duration of illness, family history and baseline symptom severity. We used the Cochrane Risk of Bias 2.0 tool to examine methodological rigor, and used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach in order to examine certainty of evidence. We obtained data from 4 studies with a total of 614 patients. Our sample represented 86% of all participants ever included in double blind placebo controlled SSRI trials for pediatric OCD. Meta-analysis showed a reduction of 3.0 CY-BOCS points compared to placebo (95% CI 2.5 - 3.5), corresponding to a small effect size (0.38 Hedges' g). Analysis of response showed an OR of 1.89 (95% CI 1.45 - 2.45). Of all possible modifiers, severity was correlated negatively with OR for response (beta -0.92, p 0.0074). Risk of bias was generally low. All studies were performed on the North American continent with an overrepresentation of White participants. Our findings were limited by the inability to include data on additional variables such as socio-economic status and comorbidities. Our IPD meta-analysis showed a small effect size of SSRIs in pediatric OCD, with baseline severity as a negative modifier of response. Generalizability of findings might be limited by selective inclusion of White, North American participants.

Longitudinal Outcomes in Noonan Syndrome

Longitudinal Outcomes in Noonan Syndrome

Individual participant data (IPD) meta-analysis: An introduction – Narrative review

Systematic reviews and meta-analyses (MA) are accepted modalities for evidence synthesis in evidence-based medicine. However, as MA uses aggregate data that includes averaging patient characteristics and pooled effect estimates, it has limitations when considering personalised medicine. In contrast, individual participant data meta-analysis (IPD-MA) includes and segregates individual patient data to study new outcomes, identify outcome predictors, and analyse multiple covariate effects on treatments. IPD-MA requires data from multiple investigators, review board approvals, clear communication with collaborators, and statistical recalculation of cumulative data. IPD-MA can be performed as a single-stage process where data from all included studies is pooled and reanalysed or as a two-stage process where additionally the data from individual studies is re-analysed before being pooled. This review aims to orient clinicians about IPD-MA, including the process of performing it, comparing it with other types of meta-analyses and considering the potential barriers in conducting it.

Differentiation between complex renal cyst and renal cell carcinoma by MRI, diffusion weighted imaging and apparent diffusion coefficient in comparison with histopathology

Background. The most frequent renal masses that are accidentally discovered during abdominal radiological imaging for various clinical causes are renal cysts. MRI used to visualize the kidneys and staging tumors in local setting. DWI and ADC maps become more familiar and has gained a definitive roles in the evaluation of renal masses. The study aimed to evaluate the radiological findings of complex renal cysts and renal cell carcinoma and to differentiate between these lesions by MRI, DW-MRI and ADC in comparison with histopathology. Methods. A comparison combine prospective-retrospective study of 18 individuals with renal lesions were enrolled in this study using MRI, DWI and ADC during a period from 26th July 2023 to 29th May 2024. Participants data included age, sex, MRI mass size, DWI, ADC maps diagnosis by MRI and histopathology diagnosis. MRI was done at 1.5 Tesla (MR Systems Achieva 1.5T TX, Philips, Netherlands). MRI findings were analyzed by two professional specialist radiologist have more than 15 years' experience. DWI diffusion in enhancing lesions was recorded and ADC maps were obtained. All lesions were proven histopathologically. Results. The most of masses were malignant (13, 72.2%) while benign masses were 5 (27.8%). The overall mean ADC of masses was 1.45± 1.28 × 10-3 mm2/s (median = 1.08 × 10-3 mm2/s). Abscesses were recorded in 3 (16.7%) patients. RCC found in 8 (44.4%) of patients, which proven by histopathology. The mean ADC was greater in benign masses than malignant masses (2.58±2.16 vs. 1.02±0.15 × 10-3 mm2/s) with strong significant difference (p=0.014). The mean ADC for the 5 benign masses were: (0.97 × 10-3 mm2/s ±0.31) for abscesses and (2.99 × 10-3 mm2/s ±0.68) for complex cyst. The mean ADC for the 13 malignant masses were as followed: RCC (1.07 × 10-3 mm2/s ±0.08), Oncocytoma (1.07 × 10-3 mm2/s ±0.007), Lymphoma (0.635 × 10-3 mm2/s) and Nephroplastoma (0.80 × 10-3 mm2/s). The ADC cut off value was (1.07 × 10-3 mm2/s), with a sensitivity of 84.62% and specificity of 80.00%. Accuracy rate was 83.33%, which was statistically significant (95%CI (0.152-0.972), P&lt;0.001), and the AUC was (0.562). Conclusions. Most of renal masses detected by MRI are malignant than benign. The most common malignant lesion is RCC and the most common benign lesion is abscesses. The differentiation between malignant and benign renal masses by MRI-DWI and ADC is equally in effectiveness of histopathology diagnosis. Significantly, the mean ADC was greater in benign masses than malignant masses (2.58±2.16 vs. 1.02±0.15 × 10-3 mm2/s). The complex cyst has greatest mean ADC value (2.99 × 10-3 mm2/s ±0.68). The mean ADC in RCC is higher than Oncocytoma, Lymphoma and Nephroplastoma. All malignant lesions have high DW and all are restricted.

Case Study of Claim Data and Participant Data in Indonesian Insurance Companies

Case Study of Claim Data and Participant Data in Indonesian Insurance Companies

Effectiveness of Installment Payment Plan Program through Face-to-Face Service Channels and Non-Face-to-Face Service Channels

This study evaluates the effectiveness of registration services for BPJS Kesehatan's REHAB (Installment Payment Plan) program through face-to-face channels at branch offices and non-face-to-face channels via the Mobile JKN application. Employing a qualitative descriptive design, data were collected from 33 informants, including frontline coordinators, frontline staff, UP3KC staff, and 30 participants using purposive sampling. Data collection methods comprised interviews, observations, and documentation, with data validity ensured through triangulation. Analysis followed Miles, Huberman, and Saldana’s interactive model, involving data reduction, presentation, and conclusion verification. Results indicate that the Mobile JKN application is the preferred registration channel due to its convenience and practicality. At the same time, face-to-face services are utilized as a backup option during technical disruptions. However, challenges such as incorrect participant data and system reliability hinder registration. This study underscores the need for improvements in the Mobile JKN system, particularly in data validation and technical stability, to enhance service accessibility and ensure seamless participant registration

Do Risk Factors for HCC Impact the Association of CT/MRI LIRADS Major Features With HCC? An Individual Participant Data Meta-Analysis.

Background: Guidelines suggest the Liver Imaging Reporting and Data System (LI-RADS) may not be applicable for some populations at risk for hepatocellular carcinoma (HCC). However, data assessing the association of HCC risk factors with LI-RADS major features are lacking. Purpose: To evaluate whether the association between HCC risk factors and each CT/MRI LI-RADS major feature differs among individuals at-risk for HCC. Methods: Databases (MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and Scopus) were searched from 2014 to 2022. Individual participant data (IPD) were extracted from studies evaluating HCC diagnosis using CT/MRI LI-RADS and reporting HCC risk factors. IPD from studies were pooled and modelled with one-stage meta-regressions. Interactions were assessed between major features and HCC risk factors, including age, sex, cirrhosis, chronic hepatitis B virus (HBV), and study location. A mixed effects model that included the major features, as well as separate models that included interactions between each risk factor and each major feature, were fit. Differences in interactions across levels of each risk factor were calculated using adjusted odds-ratios (ORs), 95% confidence-intervals (CI), and z-tests. Risk of bias was assessed using QUADAS-2. (Protocol: https://osf.io/tdv7j/). Results: Across 23 studies (2958 patients and 3553 observations), the associations between LI-RADS major features and HCC were consistent across several HCC risk factors (P-value range: .09-.99). A sensitivity analysis among the 4 studies with a low risk of bias did not differ from the primary analysis. Conclusion: The association between CT/MRI LI-RADS major features and HCC risk factors do not significantly differ in individuals at-risk for HCC. These findings suggest that CT/MR LI-RADS should be applied to all patients considered at risk by LI-RADS without modification or exclusions, regardless of the presence or absence of the risk factors evaluated in this study.

EAES rapid guideline: surgical management of complicated diverticulitis - with ESCP participation.

The surgical management of complicated diverticulitis varies across Europe. EAES members prioritized this topic to be addressed by a clinical practice guideline through an online questionnaire. To develop evidence-informed clinical practice recommendations for key stakeholders involved in the treatment of complicated diverticulitis; to improve operative and perioperative outcomes, patient experience and quality of life through a systematic evidence-to-decision approach by a diverse, multidisciplinary panel. Informed by a linked individual participant data network meta-analysis of resection and primary anastomosis (PRA) versus Hartmann's resection (HR) versus laparoscopic lavage (LPL), a panel of general and colorectal surgeons, patient partners, trialists, and fellows appraised the certainty of the evidence using GRADE and CINeMA. The panel discussed the evidence using the evidence-to-decision framework during a synchronous consensus meeting. An asynchronous modified Delphi survey was used to establish consensus. The panel suggests that patients with complicated diverticulitis without sepsis receive PRA over HR or LPL when there is availability of a surgeon with skills and experience in colorectal surgery. HR is suggested over PRA or LPL in the subgroups of septic, frail, as well as immunocompromised patients. These recommendations apply to patients with an indication for surgery. Surgeons and patients should first consider conditionally recommended interventions, then conditionally recommended against. Based on the evidence, the key benefit of PRA was a higher likelihood of not having a stoma at 1year, with similar risks across comparisons. Conditional recommendations call for shared decision-making when considering management options. The full guideline with user-friendly decision aids is available in https://app.magicapp.org/#/guideline/7490 . This clinical practice guideline provides evidence-informed recommendations on the management of patients with complicated diverticulitis in accordance with the highest methodological standards through a structured framework informed by an international, multidisciplinary panel of stakeholders.

Association between volatile organic compounds exposure and infertility risk among American women aged 18–45 years from NHANES 2013–2020

The risk of infertility is progressively escalating over the years, and it has been established that exposure to environmental pollutants is closely linked to infertility. As a prevalent environmental pollutant in daily life, there is still a lack of substantial evidence on the association between volatile organic compounds (VOCs) exposure and infertility risk. This study aimed to examine the association between VOCs exposure and the risk of female infertility in the United States. Participant data sets from three cycles (2013–2020) were collected and downloaded from the National Health and Nutrition Examination Survey (NHANES), including demographics, examination, laboratory and questionnaire data. The baseline characteristics of the included population were evaluated, and the weighted quartile logistic regression was used to analyze the association between the urinary metabolites of VOCs (mVOCs) levels and the risk of infertility. Further exploration of the relationship between mVOCs and infertility was conducted by using 35 and 25 as the cut-off points for age and BMI subgroup analyses, respectively. Restricted cubic spline (RCS) was employed to elucidate the nonlinear relationship between mVOCs and infertility risk. Additionally, the Bayesian kernel machine regression (BKMR) model with 20,000 iterations was applied to elucidate the link between mVOCs and the risk of infertility when exposed to mixed or individual mVOCs. A total of 1082 women aged 18 to 45 years were included in this study, with 133 in the infertility group and 949 in the control group. The analysis of baseline characteristics suggested that urinary 34MHA, AMCC and DHBMA levels were significantly higher in the infertility group compared to the control group (p < 0.05). Quartile logistic regression analysis indicated that AAMA (Q3), AMCC (Q4), CYMA (Q3) and HPMMA (Q3) were positively associated with infertility risk in all models (p < 0.05). Subgroup analysis revealed different risk factors for infertility among various subgroups, with CYMA consistently showing a positive correlation with infertility risk in two age subgroups (p < 0.05). Furthermore, the association between mVOCs and infertility was observed only in the subgroup with BMI ≥ 25 kg/m2. RCS analysis indicated that 2MHA, ATCA, BMA, BPMA, CYMA, 2HPMA, 3HPMA and PGA exhibited linear dose-response relationships with infertility (p > 0.05), while the remaining variables showed nonlinear relationships (p < 0.05). The BKMR model demonstrated that the risk of female infertility exhibited an increasing trend with the accumulation of mVOCs co-exposure. A positive association between the exposure to mVOCs represented by 34MHA and AMCC and the risk of infertility was observed in this research. However, the inherent limitations associated with the cross-sectional study design necessitate the pursuit of additional prospective and experimental research to further elucidate and validate the relationships between various mVOCs exposure and female infertility.