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Exploring a panel of serum biomarkers for cancer risk in patients with non-specific symptoms: a comparative analysis of feature selection methods

Por: Monroy-Iglesias · M. J. · Santaolalla · A. · Martin · S. · North · B. · Moss · C. · Haire · K. · Jones · G. · Steward · L. · Cargaleiro · C. · Bruno · F. · Millwaters · J. · Basyal · C. · Weild · S. · Russell · B. · Van Hemelrijck · M. · Dolly · S.
Objectives

Delays in cancer diagnosis for patients with non-specific symptoms (NSSs) lead to poorer outcomes. Rapid Diagnostic Clinics (RDCs) expedite care, but most NSS patients do not have cancer, highlighting the need for better risk stratification. This study aimed to develop biomarker-based clinical prediction scores to differentiate high-risk and low-risk NSS patients, enabling more targeted diagnostics.

Design

Retrospective and prospective cohort study.

Setting

Secondary care RDC in London.

Participants

Adult patients attending an RDC between December 2016 and September 2023 were included. External validation used data from another RDC.

Outcome measures

The primary outcome was a cancer diagnosis. Biomarker-based risk scores were developed using Latent Class Analysis (LCA) and Least Absolute Shrinkage and Selection Operator (LASSO). Model performance was assessed using logistic regression, receiver operating characteristic curves (AUROC) and decision curve analysis.

Results

Among 5821 RDC patients, LCA identified high white cell count, low haemoglobin, low albumin, high serum lambda light chain, high neutrophil-to-lymphocyte ratio, high serum kappa light chain (SKLC), high erythrocyte sedimentation rate (ESR), high C-reactive protein (CRP) and high neutrophils as cancer risk markers. LASSO selected high platelets, ESR, CRP, SKLC, alkaline phosphatase and lactate dehydrogenase. Each one-point increase in score predicted higher odds of cancer (LCA: AOR 1.19, 95% CI 1.16 to 1.23; LASSO: AOR 1.29, 95% CI 1.25 to 1.34). Scores ≥2 predicted significantly higher cancer odds (LCA: AOR 3.79, 95% CI 2.91 to 4.95; LASSO: AOR 3.44, 95% CI 2.66 to 4.44). Discrimination was good (AUROC: LCA 0.74; LASSO 0.73). External validation in 573 patients confirmed predicted increases in cancer risk per one-point LASSO score rise (AOR 1.28, 95% CI 1.15 to 1.42), with a borderline increase for LCA (AOR 1.16, 95% CI 1.06 to 1.27).

Conclusion

Biomarker-based scores effectively identified NSS patients at higher cancer risk. LCA captured a broader biomarker range, offering higher sensitivity, while LASSO achieved higher specificity with fewer markers. These scores may also help detect severe benign conditions, improving RDC triage. Further validation is needed before broader clinical implementation.

Photobiomodulation for postoperative pain relief following conventional periapical surgery: a randomised controlled study protocol

Por: Cirisola · R. W. C. · Moya · L. E. P. · Olazabal · M. V. G. · Wagmann · D. A. A. · Suarez · G. P. · Wince · C. · Bruno · M. L. H. · Salaberry · D. R. · Sobral · A. P. T. · Longo · P. L. · Motta · L. J. · Bussadori · S. K. · Duran · C. C. G. · Fernandes · K. P. S. · Mesquita-Ferrari
Introduction

Photobiomodulation (PBM) has shown promising effects in managing postoperative pain following conventional periapical surgery, although current evidence remains limited. This study aims to assess the effect of PBM on postoperative pain 24 hours after periapical surgery.

Methods and analysis

A randomised, controlled, double-blind trial will include 34 patients undergoing periapical surgery in the maxillary region, randomly assigned to an experimental group (n=17) or control group (n=17). The experimental group will receive PBM (GaAlAs diode laser, 808 nm, 100 mW, 4 J/cm², applied at five vestibular points) and placebo ibuprofen immediately and 24 hours postoperatively. The control group will receive simulated PBM and active ibuprofen. The primary outcome is postoperative pain assessed by the visual analogue scale at 24 hours. Secondary outcomes include pain at the seventh day, paracetamol intake, oedema, ecchymosis, soft tissue status and temperature at 24 hours and 7 days. Radiographic evaluation of healing will be performed at 1 and 3 months. Statistical analysis will be conducted based on data distribution, using repeated measures ANOVA (Analysis of Variance) or non-parametric equivalents for longitudinal outcomes, and appropriate tests for categorical variables. Significance will be set at p

Ethics and dissemination

The study was approved by the Human Research Ethics Committee of Universidad Católica del Uruguay (process no. 220914). Results will be disseminated to participants, healthcare professionals, the public and scientific communities.

Trial registration number

NCT05935306.

Developing consolidated guidelines for reporting and evaluation of studies using transcranial electrical stimulation (CoRE-tES): protocol for an international Delphi study and expert consensus process

Por: Suhood · A. Y. · Summers · S. · Pascual-Leone · A. · Nitsche · M. A. · Ziemann · U. · Bikson · M. · Lefaucheur · J.-P. · Brunoni · A. R. · Bestmann · S. · Chipchase · L. S. · Razza · L. B. · Cavaleri · R.
Introduction

In recent decades, transcranial electrical stimulation (tES) has become a widely used non-invasive method for modulating brain function in clinical and non-clinical populations. However, existing tES trials exhibit substantial methodological heterogeneity, often limiting the reproducibility and interpretability of findings. There currently exists a paucity of consensus-driven, standardised recommendations outlining the key factors that should be reported and/or controlled in tES studies. Accordingly, this project aims to develop Consolidated Guidelines for Reporting and Evaluation of studies using tES (CoRE-tES), a tool designed to assess the methodological quality and reporting of laboratory-based and home-based tES studies. These guidelines will support improved quality, consistency, replication and transparency in research involving tES modalities, including transcranial direct current stimulation, transcranial alternating current stimulation and transcranial random noise stimulation.

Methods and analysis

CoRE-tES will be developed and disseminated over five stages. Stage 1 will comprise a review of recent tES literature to assess methodological and reporting quality. Stage 2 will employ a Delphi process to seek agreement among international tES experts on a list of items for inclusion in CoRE-tES. In stage 3, a consensus meeting will be held to synthesise and prioritise the agreed items to form CoRE-tES. Stage 4 will involve production of the final CoRE-tES checklist and an accompanying evaluation and elaboration document. In stage 5, CoRE-tES will be disseminated via journal publication, conferences, professional meetings and social media campaigns.

Ethics and dissemination

Ethics approval has been obtained from the Western Sydney University Human Research Ethics Committee (approval number H16803). Findings will be disseminated through scientific conferences and peer-reviewed journal publications, and CoRE-tES will be indexed on the Enhancing the QUAlity and Transparency Of health Research Network website.

Reliability of minimally trained operators left ventricular outflow tract velocity-time integral measurement guided by artificial intelligence: protocol for a multicentre randomised controlled trial

Por: Levy · N. · Meslin · S. · Barthelemy · R. · Benremily · F. · Bourgeois · C. · Bourzeix · P. · Chousterman · B. · Djadi-Prat · J. · Ep · A. · Kezar · A. · Laidet · C. · Lanoy · E. · Leopold · V. · Pereira · H. · Plateker · O. · Rivoalen · A.-S. · de Roquetaillade · C. · Vignon · P. · Bruno
Introduction

Stroke volume is a major determinant of tissue perfusion and, therefore, a key parameter to monitor in patients with haemodynamic instability and hypoperfusion. Left ventricular outflow tract (LVOT) velocity-time integral (VTI) measurement using pulsed-wave Doppler is widely used as an estimation of stroke volume and should be a competence required for every intensive care unit (ICU) physician. Artificial intelligence (AI) applied to ultrasound facilitates the acquisition of adequate images. The aim of the present study is to evaluate the interchangeability of LVOT VTI measurements obtained by minimally trained operators and expert physicians, both guided by AI.

Methods and analysis

This is a prospective multicentre randomised controlled trial. ICU patients in whom fluid administration is considered necessary will be included. A minimally trained operator and an expert will independently measure LVOT VTI, guided by the UltraSight AI software to obtain the best five-chamber view, before and after a 250 mL fluid challenge. The order of acquisition between each operator will be randomised. 100 patients will be included.

The primary endpoint is the relative difference in LVOT VTI between operators. Secondary outcomes include the concordance of the therapeutic decision made by the blinded physician in charge of the patient based on the measures obtained by each operator, and the agreement between absolute values of LVOT VTI obtained by minimally trained and expert operators.

Ethics and dissemination

The study has been reviewed and approved by a regional ethics committee (Comité de Protection des Personnes—Ile de France II—n°24.00671.000291). An information note will be given to the participant before he or she participates in the study. The present study will be disseminated through peer-reviewed publications and academic and medical conferences.

Trial registration number

NCT06486467.

Validation of the Hospital Survey on Patient Safety Culture 2.0 in Italian Hospitals: A Cross‐Sectional Study of Healthcare Personnel Perceptions

ABSTRACT

Aim(s)

To adapt and validate the HSOPS 2 instrument for the Italian context and to describe the current patient safety culture amongst healthcare personnel working in Italian hospitals.

Design

Cross-sectional study.

Methods

We adapted and validated the HSOPS 2 instrument following the COSMIN guidelines: we performed a forward-backward translation, calculated the content validity index, evaluated face validity, acceptability (percentage of participants responding to all items on the questionnaire and to every specific item), construct validity (confirmatory factor analysis), and internal consistency (Cronbach's alpha for each dimension). We then performed a cross-sectional study following the guidelines of the original instrument: we categorised the responses into “positive,” “negative,” and “midpoints.” For each dimension we calculated the average percentage of positive responses. We repeated this process, dividing the responses by various sample characteristics (e.g., profession), and compared them using the chi-square test. Data were collected between April and November 2023.

Results

A total of 633 hospital personnel participated in the survey, and 473 completed the questionnaire in its entirety. The dimensions of “teamwork”, “supervisor”, “manager”, or “clinical leader support”, and “communication about error” emerged as dimensions with higher percentages of positive responses, while those that received lower percentages were “hospital management support for patient safety”, “staffing and work pace”, and “response to error”. We identified statistically significant differences in many dimensions between gender, profession, and clinical inpatient units.

Conclusions

These findings provide a comprehensive overview of challenges and opportunities within the healthcare sector as regards patient safety culture and can inform the development of targeted interventions aimed at improving patient safety across healthcare organisations.

Implications for the Profession and/or Patient Care

Proper assessment of safety culture, one of the main indicators of patient safety, can inform the development of effective strategies and interventions to enhance patient safety.

Impact

What problem did the study address? To effectively assess patient safety culture, it is essential to use valid and reliable tools. It is crucial to proactively assess patient safety culture in hospital personnel, whether employed in clinical units, in management, or in support services, to develop initiatives aimed at improving patient safety.

What were the main findings? The use of the adapted and validated version of the HSOPS 2 will produce valid and reliable evidence on patient safety culture. Perception of patient safety culture differs amongst respondents according to gender, profession, clinical setting. The dimensions of “hospital management support for patient safety”, “staffing and work pace”, and “response to error” were identified as those with the greatest need for improvement.

Where and on whom will the research have an impact? Patient safety heavily impacts care at every level; therefore, this study could have an impact on healthcare organisations as well as healthcare workers, patients, and their families. By making available an instrument that can contribute to a proper assessment of patient safety culture, this study might contribute to the development of appropriate strategies and targeted interventions to improve patient safety, quality of care and satisfaction while decreasing adverse events and related costs.

Reporting Method

The COSMIN guidelines were used for the validation of the instrument; the STROBE reporting guidelines were used for the cross-sectional study.

Patient or Public Contribution

No patient or public contribution.

Long-term clinical impact of sex disparities in patients with ST elevation acute myocardial infarction: a systematic review and meta-analysis of adjusted observational studies

Por: Di Pietro · G. · Improta · R. · De Filippo · O. · Birtolo · L. I. · Bruno · E. · Sardella · G. · Vizza · C. D. · DAscenzo · F. · Stefanini · G. · Mancone · M.
Objectives

We aimed to address an evidence gap by investigating the clinical impact of sex differences on long-term outcomes after primary percutaneous coronary intervention (pPCI) for acute ST-elevation myocardial infarction.

Design

Systematic review and meta-analysis.

Data sources

Medline, Scopus and EMBASE were searched through August 2024. Eligibility criteria for selecting studies. We included adjusted observational studies reporting HRs, comparing long-term clinical outcomes (beyond 1 year) between women and men undergoing pPCI for ST-elevation myocardial infarction.

Data extraction and synthesis

Two independent reviewers extracted data and assessed risk of bias using the ROBINS I (Risk Of Bias In Non-randomised Studies - of Interventions) tool. Data were pooled using generic inverse-variance weighting, computing risk estimates with 95% CIs. Heterogeneity was assessed (Cochran Q statistic) and quantified (I2 statistic).

Results

22 observational studies globally encompassing 358 140 patients (169 659 women vs 188 490 men) were included in the quantitative analysis. After a median follow-up of 3.3 years, no significant differences in terms of all-cause mortality were reported after multivariable adjustments (adjusted HR, adjHR 1.06, 95% CI 0.99 to 1.14, p=0.10). Women had a higher rate of cardiac death compared with men after multivariable adjustments (adjHR 1.86, 95% CI 1.25 to 2.77, p=0.002). No other significant differences in terms of recurrent MI, stent thrombosis and target vessel revascularisation persisted between women and men after multivariable adjustments.

Conclusions

Women undergoing pPCI for acute ST-elevation myocardial infarction experience an increased risk of cardiac death compared with men after a long-term follow-up.

PROSPERO registration number

CRD42024580932.

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