AI-assisted detection for chest X-rays (AID-CXR): a multi-reader multi-case study protocol

Introduction
A chest X-ray (CXR) is the most common imaging investigation performed worldwide. Advances in machine learning and computer vision technologies have led to the development of several artificial intelligence (AI) tools to detect abnormalities on CXRs, which may expand diagnostic support to a wider field of health professionals. There is a paucity of evidence on the impact of AI algorithms in assisting healthcare professionals (other than radiologists) who regularly review CXR images in their daily practice.

Aims
To assess the utility of an AI-based CXR interpretation tool in assisting the diagnostic accuracy, speed and confidence of a varied group of healthcare professionals.

Methods and analysis
The study will be conducted using 500 retrospectively collected inpatient and emergency department CXRs from two UK hospital trusts. Two fellowship-trained thoracic radiologists with at least 5 years of experience will independently review all studies to establish the ground truth reference standard with arbitration from a third senior radiologist in case of disagreement. The Lunit INSIGHT CXR tool (Seoul, Republic of Korea) will be applied and compared against the reference standard. Area under the receiver operating characteristic curve (AUROC) will be calculated for 10 abnormal findings: pulmonary nodules/mass, consolidation, pneumothorax, atelectasis, calcification, cardiomegaly, fibrosis, mediastinal widening, pleural effusion and pneumoperitoneum. Performance testing will be carried out with readers from various clinical professional groups with and without the assistance of Lunit INSIGHT CXR to evaluate the utility of the algorithm in improving reader accuracy (sensitivity, specificity, AUROC), confidence and speed (paired sample t-test). The study is currently ongoing with a planned end date of 31 December 2024.

Ethics and dissemination
The study has been approved by the UK Healthcare Research Authority. The use of anonymised retrospective CXRs has been authorised by Oxford University Hospital’s information governance teams. The results will be presented at relevant conferences and published in a peer-reviewed journal.

Trial registration number
Protocol ID 310995-B (awaiting approval), ClinicalTrials.gov

Leggi
Dicembre 2024

Prediction of relative survival trends in patients with cutaneous squamous cell carcinoma using a model-based period analysis: a retrospective analysis of the surveillance, epidemiology, and end results database

Objectives
Cutaneous squamous cell carcinoma (CSCC) represents a malignancy characterised by the aberrant proliferation of skin epithelial cells, and certain instances of squamous cell carcinoma (SCC) exhibit features indicative of a heightened proclivity for recurrence, metastasis, and mortality. Tracking the latest survival rates for CSCC is crucial for patient care and public health strategies.

Design
This was a retrospective study.

Setting
The Surveillance, Epidemiology, and End Results (SEER) Programme database was established by the National Cancer Institute in 1973. It is one of the commonly used cancer databases in the United States, covering a variety of tumour types including lung cancer, breast cancer, gastric cancer, colorectal cancer, prostate cancer, etc. It collects cancer diagnosis, treatment and survival data for approximately 50% of the US population, providing systematic evidence support and valuable first-hand information for clinicians’ evidence-based practice and clinical medical research. The data used in this study covers 20 years of information on patients with cutaneous squamous cell carcinoma from 2000 to 2019.

Participants
In this study, we identified a cohort of 2 04 055 patients, comprising 95 287 women and 1 08 768 men, who were diagnosed with CSCC between 2000 and 2019 in the SEER database. The inclusion criteria for this research encompassed individuals aged 15 years and older, availability of data spanning from 2000 to 2019, confirmation through microscopic examination, and the presence of a primary tumour classified as CSCC. Exclusion criteria involved cases solely validated through autopsy or a death certificate, those alive or with indeterminable survival times, and instances with incomplete data.

Outcome measures
The SEER database’s patient trends and relative survival rate for patients with CSCC were evaluated using period analysis method from 2000 to 2019. The anticipated 5 year relative survival rate among CSCC patients for the years 2020 to 2024 was projected using a generalised linear model.

Results
A total of 204,055 CSCC patients were identified, 95 287 women and 1 08 768 men. Most patients were male, white, lived in urban areas, presenting with localised metastases, aged 55–64 years, and had untyped CSCC. During the observation period, the 5 year relative survival rate of CSCC patients showed a slight improvement overall, while the 5 year relative survival rate of some subtypes showed obvious fluctuations. Particularly noteworthy was the substantial amelioration observed in the small cell nonkeratinizing SCC subtype, escalating from 60.4% in 2000 to 72.8% in 2019. The 5 year overall relative survival rates for CSCC patients during the intervals 2000–2004, 2005–2009, 2010–2014, and 2015–2019 documented rates of 62.4%, 63.4%, 64.3%, and 66.3%, respectively. Males had slightly lower survival rates than females, older patients had lower rates than younger patients, and white patients had better outcomes than non-white patients. Urban patients had higher survival rates than rural patients. Patients with distant metastases had significantly lower survival rates.

Conclusion
The temporal span from 2000 to 2019 witnessed a gradual yet delimited increase in survival rates among CSCC patients. This incremental trajectory persists, with a prognosticated survival rate of 67.1 anticipated between 2020 and 2024.

Leggi
Dicembre 2024

Incidence and prevalence of antiphospholipid syndrome (APS) in the USA (2016-2019): a retrospective database study

Objective
Few epidemiological studies are reported in the published literature on the incidence or prevalence of antiphospholipid syndrome (APS), and available results are heterogeneous. This study aimed to estimate the incidence and prevalence of APS in the USA, overall and by APS subtype.

Design
A retrospective analysis of APS disease incidence and a cross-sectional analysis of disease prevalence.

Setting
Merative MarketScan Commercial Claims and Encounters Database, and the Medicare Supplemental and Coordination of Benefits Database.

Participants
All individuals with claims for at least two antiphospholipid antibody tests undertaken at least 12 weeks apart and a diagnosis claim for APS as a primary or secondary diagnosis on or after the second antibody test, during the period 1 January 2016 to 31 December 2019.

Main outcome measures
Annual incidence and prevalence of APS and APS subtypes.

Results
In total, 1708 cases of APS were identified during the study period (2016–2019), of which 83% were women. The overall annual standardised incidence rate of APS per 100 000 person-years increased slightly over the study period, from 2.31 in 2016 to 2.71 in 2019. In 2019, the estimated annual prevalence of APS per 100 000 persons was 10.42 per 100 000 persons (95% CI 9.96–10.90). Based on this and US census data, we have estimated that 34 000 persons in the USA were affected by APS in 2019.

Conclusions
These data add to the estimates of prevalence and incidence of APS in the literature, all of which have different strengths and limitations of the different data sources and case ascertainment methods.

Leggi
Dicembre 2024

Processes and approaches to perioperative pain management in patients undergoing major lower extremity amputations secondary to vascular disease: a multi-specialty modified Delphi consensus study protocol

Introduction
Pain surrounding major lower extremity amputations (MLEAs) in the vascular surgical patient can be severe, conferring significant debilitation from the preoperative stage through to the chronic rehabilitation phase. Although there is an evolving understanding of the array of existing analgesic medications and modalities, pain management in this context continues to be challenging. A previous report in the UK revealed that MLEA pain management practices may not be optimal from the perspective of patients. There are also limitations in the comprehensiveness and quality of existing evidence, and existing practices can be heterogeneous. Identifying effective pain management approaches in MLEA has thus been recognised as a key practice and research priority. Therefore, the aim of this study protocol will be to elucidate a multi-specialty view on the perceptions, processes and approaches to perioperative pain management in patients undergoing MLEAs secondary to vascular disease in the UK.

Methods and analysis
A modified Delphi methodology will be used to gain consensus among a UK-wide multi-specialty panel of clinical experts. At least three iterative rounds of structured anonymous electronic surveys will be circulated to a minimum cohort of 40 participants across relevant specialties. Expert agreement on pre-developed consensus statements pertaining to the approaches and techniques in MLEA pain management will be sought from the first round and quantified by a 5-point Likert scale. Quantitative and qualitative analyses will be performed to evaluate the level of agreement and participant feedback, respectively. A consensus criterion of ≥75% panellist agreement with a ≤10% between-round stability will be used for each statement. The process will be repeated with the results and implementation of feedback highlighted to panellists in each subsequent round.

Ethics and dissemination
Ethical approval was not required for this study as the participants and methodology fall outwith the requirements for a National Health Service Research Ethics Committee review. The results will be disseminated in a peer-reviewed publication and presented at relevant conferences.

Leggi
Dicembre 2024

Cohort profile: the WHO Child Mortality Risk Stratification Multi-Country Pooled Cohort (WHO-CMRS) to identify predictors of mortality through early childhood

Purpose
To provide details of a pooled data set that will be used to estimate absolute and relative mortality risks and other outcomes among children less than 59 months of age and the predictive performance of common risk exposures, both individually and in combination.

Participants
Children from birth to 5 years of age recruited at health facilities or community settings into 33 longitudinal observational or intervention studies in 17 low- and middle-income countries.

Findings to date
The data set includes 75 287 children with a median age of 3 months (IQR 1–12) at first measurement. In the pooled sample, 2805 (3.7%) of the study children died. Data on birth weight was recorded in 19 studies, and gestational age in 13 studies. Among these, 14% of the included children were reported as having low birth weight, and 14% had preterm birth. At first measurement, 33% of the children were stunted, 24% were wasted and 35% underweight. 13% and 7% of caregivers reported that their child had acute diarrhoea or acute lower respiratory tract infection before the study visit, respectively. The proportion of children reported as breastfed at any study visit decreased from 99% at age

Leggi
Novembre 2024

Monitoring drug Efficacy through Multi-Omics Research initiative in Alzheimers Disease (MEMORI-AD): A protocol for a multisite exploratory prospective cohort study on the drug response-related clinical, genetic, microbial and metabolomic signatures in Filipino patients with Alzheimers disease

Introduction
Dementia is one of the leading causes of disability among older people aged 60 years and above, with majority eventually being diagnosed with Alzheimer’s disease (AD). Pharmacological agents approved for dementia include acetylcholinesterase enzyme (AChE) inhibitors like rivastigmine, donepezil and galantamine and the N-methyl-D-aspartate (NMDA) receptor antagonist memantine, prescribed as monotherapy or in combination with each other, depending on the severity of disease. There is currently no available study demonstrating the clinical response to these drugs for AD in the Filipino population. Hence, this protocol aims to characterise the clinical, genetic, microbial and metabolic factors associated with drug responses to donepezil, rivastigmine and/or memantine for AD in a cohort of Filipinos with late-onset AD.

Methods and analysis
This protocol involves a multisite descriptive study that will use two study designs: (1) a descriptive, cross-sectional study to characterise the clinical profile of Filipino dementia patients with AD and (2) an exploratory prospective cohort study to investigate drug response-related genetic, gut microbiome and metabolome signatures of a subset of the recruited AD patients. At least 153 patients with mild or moderate AD aged 65 years old and above will be recruited regardless of their treatment status. A subset of these patients (n=60) who meet inclusion and exclusion criteria will be included further in the exploratory cohort study. These patients will be grouped according to their baseline medications and will be observed for treatment response in 6 months. The cognitive, functional and behavioural domains of patients and levels of functioning will be measured using different assessment tools. Drug responses of Filipino patients will then be investigated employing multi-omics technology to characterise genetic variations via whole exome sequencing, gut microbiome profile via shotgun metagenomic sequencing and metabolome profile via liquid chromatography with mass spectrometry.

Ethics and dissemination
The study has received ethical clearance from the Department of Health Single Joint Research Ethics Board (SJREB-2022–15). Results of psychometric scales will be made available to enrolled patients. The study results will be presented at national/international conferences and published in international peer-reviewed scientific journals, and summaries of the results will be provided to the study funders and institutional review boards of the three tertiary referral hospitals.

Trial registration number
Philippine Health Research Registry ID PHRR230220-0054116; ClinicalTrials.gov ID NCT05801380

Leggi
Novembre 2024

Constipation among workers with depression/anxiety: a retrospective study using a claims database and survey data in Japan

Objectives
To investigate the prevalence, associated factors, treatment status and burden of constipation in workers with depression or anxiety.

Study design
This was a retrospective observational study using a pre-existing database.

Setting
Claims data from October to November 2022 and data from the survey conducted in November 2022 were extracted from the database.

Participants
This study included self-reported workers who completed the survey, after excluding those with major mental disorders diagnosed as distinct from depression or anxiety and constipation due to organic diseases identified by International Classification of Diseases (ICD-10) codes.

Outcome measures
The subjects were divided into three groups: treated depression/anxiety, untreated depression/anxiety and no depression/anxiety. The prevalence of constipation, factors associated with constipation and medications prescribed for constipation were analysed. Work productivity and quality of life (QOL) were compared between three subgroups based on constipation status: treated constipation, untreated constipation and no constipation subgroup.

Results
Of the 18 585 respondents in the analysis population, 950 respondents (5.1%) were classified into the treated depression/anxiety group, 6035 respondents (32.5%) into the untreated depression/anxiety group and the remaining respondents into the no depression/anxiety group (11 600 (62.4%)). The prevalence of constipation was 22.5% in the treated group, 22.3% in the untreated group and 10.4% in the no depression/anxiety group, respectively. Depression and anxiety severity were independently associated with an increased risk of constipation. In all groups, the most commonly prescribed drug class was osmotic laxatives. Work productivity and QOL tended to indicate a greater burden in the untreated constipation subgroup than in the treated or no constipation subgroups.

Conclusions
The prevalence of constipation was twice as high if workers had depression/anxiety. Considering that the comorbidity of constipation with mental disorders may increase multiple burdens, appropriate medical interventions are required to treat both mental (depression/anxiety) and physical (constipation) conditions. This should be widely recognised by physicians and employers.

Leggi
Novembre 2024