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Data availability
The datasets generated during and/or analyzed during the current study are available from the corresponding authors on reasonable request.
PMC9870900
Competing interests
The authors declare no competing interests.
PMC9870900
References
PMC9870900
Background
RECURRENCE, ATRIAL FIBRILLATION (AF)
A number of models have been reported for predicting atrial fibrillation (AF) recurrence after catheter ablation. Although many machine learning (ML) models were developed among them, black-box effect existed widely. It was always difficult to explain how variables affect model output. We sought to implement an explain...
PMC9936738
Methods
Between January 2018 and December 2020, 471 consecutive patients with paroxysmal AF who had their first catheter ablation procedure were retrospectively enrolled. Patients were randomly assigned into training cohort (70%) and testing cohort (30%). The explainable ML model based on Random Forest (RF) algorithm was devel...
PMC9936738
Results
RECURRENCES, RECURRENCE
In this cohort, 135 patients experienced tachycardias recurrences. With hyperparameters adjusted, the ML model predicted AF recurrence with an area under the curve of 66.7% in the testing cohort. Summary plots listed the top 15 features in descending order and preliminary showed the association between features and out...
PMC9936738
Conclusion
RECURRENCE, PAROXYSMAL ATRIAL FIBRILLATION
An explainable ML model effectively revealed its decision-making process in identifying patients with paroxysmal atrial fibrillation at high risk for recurrence after catheter ablation by listing important features, showing the impact of every feature on model output, determining appropriate thresholds and identifying ...
PMC9936738
Supplementary Information
The online version contains supplementary material available at 10.1186/s12872-023-03087-0.
PMC9936738
Keywords
PMC9936738
Introduction
drug-refractory
ATRIAL FIBRILLATION (AF)
One of the primary treatment options for atrial fibrillation (AF) is rhythm control. Catheter ablation is the first-line treatment for drug-refractory paroxysmal AF, and pulmonary vein isolation, the cornerstone of AF ablation, eradicates approximately 90% of AF triggers in principle [Numerous studies have proposed a v...
PMC9936738
Methods
PMC9936738
Study design and population
AF, mitral stenosis, drug-refractory
MITRAL STENOSIS, PRIMARY CARDIOMYOPATHY, HYPERTHYROIDISM, HYPERTROPHIC CARDIOMYOPATHY, SICK SINUS SYNDROME
A consecutive cohort of patients was included in the study from the First Affiliated Hospital of Air Force Medical University between January 2018 and December 2020. Patients over 18 years old with drug-refractory paroxysmal AF, who received their first catheter ablation procedure were eligible. Exclusion criteria incl...
PMC9936738
Data collection
ATRIAL FIBRILLATION
With "Atrial Fibrillation" as the search term, all patients hospitalized in the department of cardiovascular medicine from January 2018 to December 2020 were retrieved, and basic information of patients, including age, sex and ID number, were collected. Retrieval logic written in R language was used to automatically re...
PMC9936738
Feature selection
embolism
EMBOLISM, INFLAMMATION
To ensure the robustness of the ML classification model, features were selected if they: (i) characterized the cardiac function, risk of systemic embolism or the level of inflammation, or (ii) promoted the occurrence and development of AF. Laboratory and echocardiographic characteristics were considered as missing valu...
PMC9936738
End point and follow-up
atrial flutter, atrial tachycardia
RECURRENCE, RECURRENCE, ATRIAL TACHYCARDIA, ATRIAL FLUTTER, INFLAMMATORY RESPONSE
Recurrence of AF post-procedure was defined as the first episode of any type of atrial tachycardia, including but not limited to atrial flutter and AF, sustained for more than 30 s after the blanking period (BP). BP refers to the first three months post-procedure. In this period, any occurrence of atrial tachycardia wa...
PMC9936738
Explainable ML model
The Random Forest (RF) algorithm was used in the building of an explainable ML model.
PMC9936738
Classifier illustration
DTS
RF is an ensemble algorithm based on the Decision Tree (DT). The basic idea of RF is bagging: features selected into the RF model are simultaneously voted by all independent DTs in the forest, and this process conforms to the principle of majority subordination. RF integrates the results of all DTs, obtaining higher mo...
PMC9936738
Model development, validation and testing
overfitted
DTS
The median of each feature was used to fill in the missing values, preserving the distribution of data to the greatest extent. However, underestimation of the weight of features using this method is possible. All patients and their specific characteristics in this cohort were randomly divided into the training and test...
PMC9936738
Model explanation
Shapley additive explanations (SHAP) analysis is derived from a game theory concept and has the advantage of gaining insight into the association between observations and clinical outcome [
PMC9936738
Statistical analysis
SD
REGRESSION, RECURRENCE
Because the missing values for most laboratory examination and echocardiographic indexes were replaced with their medians, they were described as the median (IQR) and compared using Mann–Whitney U test. Continuous variables with normal distribution were expressed as the mean ± SD and compared by one-way ANOVA. Categori...
PMC9936738
Results
PMC9936738
Patients and baseline characteristics
tachycardias
RECURRENCES
A total of 1496 patients were screened in this study. Finally, 471 patients were enrolled. The median follow-up time was 25 months (IQR: 13–36 months). Patient follow-up totaled an aggregate of 954.3 patient-years with 135 patients (14.2/100 patient-years) experiencing tachycardias recurrences (Additional file The enti...
PMC9936738
Model development
DBP diastolic blood pressure
ATRIAL FIBRILLATION, RECURRENCE
Based on the 7:3 ratio, 329 and 142 patients were randomly assigned into the training and testing cohorts, respectively. Baseline characteristics are summarized in Table Baseline characteristics between training cohort and testing cohortData are mean ± SD, median (IQR) or n (%)AF duration indicates time since first AF ...
PMC9936738
SHAP analysis
SHAP dependence
The top 15 features with descending importance ranked by mean absolute SHAP values are shown in the summary plot (Fig. Summary plot for ML model. Summary plot Decision plot and force plot for ML model. SHAP dependence plots show the impact of a single feature on outcome prediction (Fig. The impact of single feature on ...
PMC9936738
Statistical significance of thresholds
SBP systolic blood pressure
REGRESSION, ATRIAL FIBRILLATION
Statistical thresholds of continuous variables in the training cohort evaluated by Youden index were similar to those determined by SHAP analysis (Table Thresholds of continuous variables in training cohort based on Youden indexBMI body mass index, AF atrial fibrillationUnivariable Cox proportional hazard regression ba...
PMC9936738
Discussion
RECURRENCE
In this study, an explainable ML model was developed and tested to reveal its decision-making process in identifying patients with paroxysmal AF at high risk for recurrence after catheter ablation. The top 15 features and their specific impact on outcome prediction were revealed through SHAP analysis. ERAF showed the m...
PMC9936738
Risk factors identification
RECURRENCE
Risk assessment for AF recurrence after catheter ablation remains a topic worth exploring. According to current guidelines, despite the fact that a series of prediction scores have been evaluated, their prediction ability is moderate; the most powerful predictor is ERAF [
PMC9936738
Relationship between single feature and model output
SHAP analysis could illuminate the effect of every feature on the outcome from an objective perspective. CHA
PMC9936738
Threshold determination
A threshold determines the score of each continuous variable in the clinical model, for example, age in CHAThe thresholds of laboratory examination indexes evaluated by SHAP analysis were inaccurate. For example, the threshold of NT-proBNP was 52.28 pg/ml, which was less than the upper limit of regular medical referenc...
PMC9936738
Model performance in high-dimensional data
REGRESSION
Multivariable Cox regression results showed that ERAF, AF duration and left ventricular ejection fraction were statistically significant, with an AUROC value of 0.513 (Additional file Currently, there are conflicting reports as to whether ML models perform better than traditional statistical methods. Moncada et al. [Re...
PMC9936738
Explainable ML model in clinical practice
Explainable ML model can make clinical practice more accurate. When the characteristics of each patient are entered into the model, the model first predicts whether he or she is at high risk. After that, we can understand the decision-making process of the model through SHAP analysis. According to the weight of differe...
PMC9936738
Limitations
chronic obstructive pulmonary disease
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
There were several limitations in this study. The sample size in our study was small. Median values were used to fill in the missing data for laboratory examinations and echocardiographic indicators, which may reduce power of test and representativeness. Potential risk factors proposed by other studies such as abnormal...
PMC9936738
Conclusions
RECURRENCE, PAROXYSMAL ATRIAL FIBRILLATION
This study showed that the explainable machine learning model can effectively reveal its decision-making process in identifying patients with paroxysmal atrial fibrillation at high risk for recurrence after catheter ablation by listing important features, showing the impact of every feature on model output, determining...
PMC9936738
Acknowledgements
Not applicable.
PMC9936738
Author contributions
MH
FY conceived and supervised the study. YM and DZ participated in the design of the study, performed statistical analysis of the data and drafted the manuscript. JX and HP participated in clinical follow-up. JL, LG and SZ participated in data collection and verification. MH revised this paper. All of the authors read an...
PMC9936738
Funding
The present work was financially supported by General program of National Natural Science Funds of China (Grant No. 81970274).
PMC9936738
Availability of data and materials
The datasets used and/or analyzed during the current study can be available from the corresponding author on reasonable request.
PMC9936738
Declarations
PMC9936738
Ethics approval and consent to participate
This study confirmed to Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) statement and was approved by the ethics committee of the First Affiliated Hospital of Air Force Medical University according to the principles of the Declaration of Helsinki. Written informe...
PMC9936738
Consent for publication
Not applicable.
PMC9936738
Competing interests
The authors declare no competing interests.
PMC9936738
References
PMC9936738
Background
type 2 diabetes mellitus, diabetes
DISEASE, TYPE 2 DIABETES MELLITUS, COMPLICATIONS, DIABETES
Medically underserved people with type 2 diabetes mellitus face limited access to group-based diabetes care, placing them at risk for poor disease control and complications. Immersive technology and telemedicine solutions could bridge this gap.
PMC10209787
Objective
diabetes
DIABETES
The purpose of this study was to compare the effectiveness of diabetes medical group visits (DMGVs) delivered in an immersive telemedicine platform versus an in-person (IP) setting and establish the noninferiority of the technology-enabled approach for changes in hemoglobin A
PMC10209787
Methods
TYPE 2 DIABETES MELLITUS
This study is a noninferiority randomized controlled trial conducted from February 2017 to December 2019 at an urban safety net health system and community health center. We enrolled adult women (aged ≥18 years) who self-reported African American or Black race or Hispanic or Latina ethnicity and had type 2 diabetes mel...
PMC10209787
Results
Of 309 female participants (mean age 55, SD 10.6 years; n=195, 63% African American or Black; n=105, 34% Hispanic or Latina; n=151 IP; and n=158 in VW), 207 (67%) met per-protocol criteria. In the intention-to-treat analysis, we confirmed noninferiority for primary outcomes. We found similar improvements in mean HbA
PMC10209787
Conclusions
diabetes
DIABETES
In this noninferiority randomized controlled trial, immersive telemedicine was a noninferior platform for delivering diabetes care, eliciting comparable glycemic control improvement, and enhancing patient engagement, compared to IP DMGVs.
PMC10209787
Trial Registration
ClinicalTrials.gov NCT02726425; https://clinicaltrials.gov/ct2/show/NCT02726425
PMC10209787
Introduction
T2DM, diabetes
TYPE 2 DIABETES MELLITUS, DIABETES
Minority and low-income women with type 2 diabetes mellitus (T2DM) face widening disparities in diabetes care and clinical outcomes, highlighting the pressing need to improve diabetes care for underserved communities [Telehealth solutions have gained unprecedented traction with the onset of the COVID-19 pandemic. Early...
PMC10209787
Methods
PMC10209787
Trial Design
T2DM
From February 2017 to October 2019, we recruited 17 cohorts of African American or Black or Hispanic or Latina women with uncontrolled T2DM. A total of 309 participants were enrolled and randomly assigned to the VW or IP DMGV conditions. Participants attended 8 weekly DMGVs and were followed for 6 months.
PMC10209787
Participants
T2DM
Eligible participants were adult women (≥18 years) who self-identified as African American, Black, Hispanic, or Latina with uncontrolled T2DM, defined by a hemoglobin A
PMC10209787
Recruitment
PMC10209787
Overview
We identified participants from Boston Medical Center and a local community health center using a weekly electronic medical record query. We contacted eligible participants with an introductory letter and follow-up call [
PMC10209787
Randomization and Masking
After stratification by language, we used one-to-one block randomization (alternating blocks of 6 and 8) to assign participants to the VW or IP DMGV conditions. A biostatistician generated the randomization sequence, and randomization occurred after informed consent. We randomized participants prior to obtaining baseli...
PMC10209787
Intervention
diabetes
DIABETES
Assigned to cohorts of 6-12 participants based on study arm, participants convened in clinical or virtual settings for 8 weekly DMGVs. Each session lasted approximately 120 minutes and started with the completion of an intake form to document acute or chronic symptoms, health system usage, and self-management activitie...
PMC10209787
Outcomes
The primary outcomes were mean changes in (1) HbA
PMC10209787
Data Collection and Management
Baseline data collection included sociodemographic characteristics, HbA
PMC10209787
Sample Size Calculations
We used the average overtime change in HbA
PMC10209787
Statistical Analysis
SENSITIVITY
Sociodemographic characteristics were compared by arm using chi-square and Fisher exact tests as appropriate for categorical variables and 2 sample Accelerometry data was used to calculate participants’ mean change in physical activity behavior from baseline to 6 months. For each participant, we randomly selected the 2...
PMC10209787
Ethics Approval
This study was conducted according to the CONSORT (Consolidated Standards of Reporting Trials) guidelines [
PMC10209787
Results
PMC10209787
Fidelity
EVENTS
The 17 study cohorts were conducted with 98% fidelity to the 8-week curriculum. The median number of sessions attended by participants was 6 in the IP arm and 7 in the VW arm. Among participants who attended WIC2 DMGVs, 98.2% (1618/1648 total events) completed the clinician consult and intake forms. In the VW condition...
PMC10209787
PP Results
Among the 207 participants who attended at least 6 DMGVs, within-group mean HbA
PMC10209787
Lifestyle Behaviors
diabetes
DIABETES
Self-management behaviors were assessed through a weekly self-report to detect changes in diet, exercise, and diabetes-related medication. Nearly a third of all participants (89/309, 28.8%) reported ≥1 dietary change, with a greater proportion in the VW group compared to the IP group (55/158, 34.8% vs 34/151, 22.5%).Of...
PMC10209787
Adverse Events
ADVERSE EVENT
One study-related severe adverse event in the VW group occurred due to emotional distress.
PMC10209787
Discussion
PMC10209787
Principal Findings
depressive symptoms, depression, T2DM, diabetes distress, diabetes
DIABETES
To our knowledge, this is the first fully powered clinical trial to demonstrate the effectiveness of delivering DMGVs using an immersive 3D telemedicine platform versus IP care. Both approaches were similarly effective in reducing mean HbAOur preliminary study compared IP versus immersive DSME delivery among 89 low-inc...
PMC10209787
Limitations
We acknowledge several study limitations. We had a small imbalance in HbA
PMC10209787
Conclusions
Shakiyla, Diabetes, Digestive, diabetes
KIDNEY DISEASES, DIABETES, RECRUITMENT, DIABETES
Immersive technologies can reduce disparities by improving effectiveness and access to evidence-based diabetes care. We showed that when given the tools, adults from digitally underserved communities robustly adopt health technology tools with improved health outcomes. More effort is warranted to design technology tail...
PMC10209787
Abbreviations
diabetes
DIABETES
Consolidated Standards of Reporting Trialsdiabetes distressdiabetes medical group visitdiabetes self-management educationhemoglobin Ain-personintention-to-treatmetabolic equivalent of taskPatient Health Questionnaire-8per-protocoltype 2 diabetes mellitusvirtual worldWomen in Control 2.0
PMC10209787
Data Availability
SECONDARY
The WIC2 team agrees to share deidentified individual participant data that underlie the results reported in this study, the study protocol, and the statistical analysis plan. Data will be available for 6 months following publication for 5 years. Data will only be shared with academic researchers who provide a methodol...
PMC10209787
Methods
Cancer, NRS, pain
ADVANCED CANCER, CANCER
Adults with advanced cancer and scored worst pain ≥ 2/10 on a numeric rating scale (NRS) were recruited from 6 Australian oncology/palliative care outpatient services to the Stop Cancer PAIN trial (08/15-06/19). Out-of-hospital, publicly funded services, prescriptions and costs were estimated for the three months befor...
PMC9974128
Results
cancer type, reflux disease, GORD, pain
Overall, 212 participants had median worst pain scores of five (inter-quartile range 4). The most frequently prescribed medications were opioids (60.1%) and peptic ulcer/gastro-oesophageal reflux disease (GORD) drugs (51.6%). The total average healthcare cost in the three months before the census date was A$6,742 (95% ...
PMC9974128
Conclusions
cancer, peptic, pain
CANCER
In this population with pain and cancer, there was no clear relationship between healthcare costs and pain severity. These treatment patterns requiring further exploration including the prevalence of peptic ulcer/GORD drugs, and lipid lowering agents and the higher healthcare costs for men.
PMC9974128
Data Availability
Cancer
CANCER
This dataset contains sensitive patient information and patient consent was not obtained to share data. To remain compliant with university, state government, and data custodian ethical requirements, access to the dataset is restricted. Further, data cannot be shared publicly by the authors because the analysis draws o...
PMC9974128
Introduction
Pain, cancer pain, pain, cancer-related pain, Cancer
DISEASE, ADVANCED CANCER, CANCER
Approximately 70% of patients living with advanced cancer experience pain [Pain is associated with poorer quality of life [Cancer is the leading cause of social and economic burden in Australia [However, no studies have investigated the relationship between healthcare usage and pain intensity in people with advanced ca...
PMC9974128
Aim
pain
ADVANCED CANCER
The aims of this study were to:identify treatment patterns and corresponding costs of healthcare resource use (government funded) for outpatients living with advanced cancer and pain;explore factors associated with healthcare costs in this population; andexamine the relationship between healthcare costs and pain intens...
PMC9974128
Methods
PMC9974128
The Stop Cancer PAIN Trial
cancer-related pain, cancer, cancer pain, pain, NRS, Cancer
CANCER, ADVANCED CANCER, SECONDARY, CANCER
This pragmatic, phase III, stepped-wedge, cluster randomised controlled trial investigated the effectiveness of screening and guidelines for pain with, versus without, implementation strategies for improving cancer pain.From August 2015 to June 2019, adults with cancer and pain presenting to six oncology and palliative...
PMC9974128
Treatment patterns and out-of-hospital healthcare resource utilisation
illness, Cancer
CANCER
The Stop Cancer PAIN Trial database was linked to routinely collected out of hospital services (Medicare Benefits Schedule) and medication data (Pharmaceutical Benefits Schedule) to explore treatment patterns and estimate healthcare resource utilisation. Ethics approval was granted by the South Western Sydney Local Hea...
PMC9974128
Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Schedule (PBS)
Medicare is the publicly funded universal healthcare scheme in Australia providing access to subsidised medical services for all residents [
PMC9974128
Outcome measures
cancer
CANCER
Participants demographics and cancer diagnoses details were collected [
PMC9974128
Pain Numeric Rating Scale (NRS)
pain
The pain NRS is a widely used, self-completed, validated pain scale [
PMC9974128
EORTC QLQ C15-PAL
Cancer
CANCER
The European Organisation for Research and Treatment of Cancer Quality of Life-C15-Palliative questionnaire (‘C15-PAL’) is a shortened version of the QLQ-C30, and contains 15 of the 30 original items [
PMC9974128
EORTC QLU-C10D
cancer
CANCER
The C15-PAL does not provide a total score reflecting the health-related quality of life of people living with cancer and cannot be used to inform economic evaluations because this patient-reported outcome measure is not preference based, i.e. does not enable the calculation of utility values. The EORTC QLU-C10D [
PMC9974128
Data linkage
Cancer
CANCER
Medicare Benefit Schedule and PBS data were requested for all consented participants. The Department of Human Services carried out probabilistic linkage to the Stop Cancer PAIN Trial ID with the MBS and PBS database based on key variables such as date of birth and Medicare number and provided anonymised data to the lea...
PMC9974128
Analysis
pain
Analyses were performed using SPSS for Windows version 25.0 (SPSS, Inc., Chicago, IL) and Stata version 16.0 (StataCorp. 2019. Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC) on available data. Descriptive summary statistics were estimated for clinico-demographic variables, NRS pain and HrQO...
PMC9974128
Results
PMC9974128
Sample characteristics
Cancer
CANCER
In total, 30.8% (n = 212) of patients who participated in the Stop Cancer PAIN Trial consented to having their MBS and/ or PBS data accessed. Overall, total healthcare costs and Stop Cancer PAIN Trial data were available for 186 participants (MBS costs, n = 186, PBS costs n = 188) for this study (missing trial data, n ...
PMC9974128
Participant demographics and clinical characteristics.
pain
IQR = inter-quartile range; NRS = pain numerical rating scale; SD = standard deviation
PMC9974128
2. Factors associated with healthcare costs
pain
Spearman’s rank correlations between total healthcare costs and age, pain intensity and HrQOL and QLU-C10D scores were in the anticipated directions but weaker than expected especially for pain intensity (
PMC9974128
Correlations between total healthcare, MBS and PBS costs and age, pain intensity and health-related quality of life.
cancer, pain
CANCER
Sample sizes vary due to missing data; HrQOL = health-related quality of life; MBS = Medicare Benefits Schedule; NRS = pain numerical rating scale; PBS = Pharmaceutical Benefits Schedule; Correlations were interpreted according to Cohen’s guidelines, i.e., “strong” (≥0.51), “moderate” (0.31–0.50), “weak” (0.11–0.30), a...
PMC9974128
Unadjusted, mean healthcare costs by clinico-demographic characteristics.
cancer, lung cancers, pain, head and neck cancers
CANCER, LUNG CANCERS, HEAD AND NECK CANCER
KW = Kruskal-Wallis; MBS = Medicare Benefits Schedule; MWU = Mann-Whitney U; NRS = numeric rating scale; PBS = Pharmaceutical Benefits Schedule; SD = standard deviation. Shaded cells indicate statistically significant differences.Mean total MBS and PBS costs varied by cancer type. Mean total MBS costs were highest for ...
PMC9974128
3. Relationship between healthcare costs and pain intensity
cancer, Pain
CANCER
Pain intensity was not associated with healthcare costs after adjusting for age and sex (see Table 6 in Pain intensity was also not associated with mean total MBS costs after adjusting for age, sex and cancer type (see Table 7 in Exploratory,
PMC9974128
Discussion
cancer, pain
CANCER, ADVANCED CANCER, PEPTIC ULCERS, GASTROESOPHAGEAL REFLUX DISEASE
The findings suggest government funded, out-of-hospital costs are, on average, $2,247 per month for people living with advanced cancer and pain, i.e. approximately $27,000 per year, higher than recently reported MBS and PBS costs for the first 12-months following cancer diagnoses in Queensland, Australia (approximately...
PMC9974128
Top 10 most frequently prescribed medicines.
cancer type, cancer, breathlessness, pain
DISEASE, CANCER, ADVANCED CANCER
More than one in five people with advanced cancer and pain were prescribed a lipid modifying agent, contrary to guidance to reduce the burden of medications in advanced disease, particularly from medications such as statins which are only prescribed for long term population-level risk reduction [The remaining top ten m...
PMC9974128
Strengths and limitations
ADVANCED CANCER
Consent to access MBS and PBS data was granted by just under a third of study participants and findings may not reflect treatment patterns in the entire study cohort. However, unlike healthcare resource utilisation data collected using other means such as surveys, Medicare and PBS data are not prone to recall bias and ...
PMC9974128
Implications for research and practice
peptic, pain
ADVANCED CANCER
The findings identify areas of treatment for outpatients with advanced cancer and pain requiring further exploration and practice change, particularly the high use of peptic ulcer/GORD drugs, lipid modifying agents and corticosteroids. Further research is needed to determine why healthcare costs were higher in men than...
PMC9974128
Conclusions
cancer, pain
CANCER
This study provides vital information for informing quality of care and quality use of medicines, resource allocation and developing sustainable health policy. There was no clear relationship between pain intensity and healthcare costs demonstrated in this population with pain. Investigation into the underpinning ratio...
PMC9974128