Patients and Stakeholders' Perspectives Regarding the Privacy, Security, and Confidentiality of Data Collected via Mobile Health Apps in Saudi Arabia: Protocol for a Mixed Method Study.

BACKGROUND: There is data paucity regarding users' awareness of privacy concerns and the resulting impact on the acceptance of mobile health (mHealth) apps, especially in the Saudi context. Such information is pertinent in addressing users' needs in the Kingdom of Saudi Arabia (KSA). OBJECTIVE: This article presents a study protocol for a mixed method study to assess the perspectives of patients and stakeholders regarding the privacy, security, and confidentiality of data collected via mHealth apps in the KSA and the factors affecting the adoption of mHealth apps. METHODS: A mixed method study design will be used. In the quantitative phase, patients and end users of mHealth apps will be randomly recruited from various provinces in Saudi Arabia with a high population of mHealth users. The research instrument will be developed based on the emerging themes and findings from the interview conducted among stakeholders, app developers, health care professionals, and users of mHealth apps (n=25). The survey will focus on (1) how to improve patients' awareness of data security, privacy, and confidentiality; (2) feedback on the current mHealth apps in terms of data security, privacy, and confidentiality; and (3) the features that might improve data security, privacy, and confidentiality of mHealth apps. Meanwhile, specific sections of the questionnaire will focus on patients' awareness, privacy concerns, confidentiality concerns, security concerns, perceived usefulness, perceived ease of use, and behavioral intention. Qualitative data will be analyzed thematically using NVivo version 12. Descriptive statistics, regression analysis, and structural equation modeling will be performed using SPSS and partial least squares structural equation modeling. RESULTS: The ethical approval for this research has been obtained from the Biomedical and Scientific Research Ethics Committee, University of Warwick, and the Medical Research and Ethics Committee Ministry of Health in the KSA. The qualitative phase is ongoing and 15 participants have been interviewed. The interviews for the remaining 10 participants will be completed by November 25, 2023. Preliminary thematic analysis is still ongoing. Meanwhile, the quantitative phase will commence by December 10, 2023, with 150 participants providing signed and informed consent to participate in the study. CONCLUSIONS: The mixed methods study will elucidate the antecedents of patients' awareness and concerns regarding the privacy, security, and confidentiality of data collected via mHealth apps in the KSA. Furthermore, pertinent findings on the perspectives of stakeholders and health care professionals toward the aforementioned issues will be gleaned. The results will assist policy makers in developing strategies to improve Saudi users'/patients' adoption of mHealth apps and addressing the concerns raised to benefit significantly from these advanced health care modalities. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54933.

Patients' Perspectives on the Data Confidentiality, Privacy, and Security of mHealth Apps: Systematic Review.

BACKGROUND: Mobile health (mHealth) apps have the potential to enhance health care service delivery. However, concerns regarding patients' confidentiality, privacy, and security consistently affect the adoption of mHealth apps. Despite this, no review has comprehensively summarized the findings of studies on this subject matter. OBJECTIVE: This systematic review aims to investigate patients' perspectives and awareness of the confidentiality, privacy, and security of the data collected through mHealth apps. METHODS: Using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, a comprehensive literature search was conducted in 3 electronic databases: PubMed, Ovid, and ScienceDirect. All the retrieved articles were screened according to specific inclusion criteria to select relevant articles published between 2014 and 2022. RESULTS: A total of 33 articles exploring mHealth patients' perspectives and awareness of data privacy, security, and confidentiality issues and the associated factors were included in this systematic review. Thematic analyses of the retrieved data led to the synthesis of 4 themes: concerns about data privacy, confidentiality, and security; awareness; facilitators and enablers; and associated factors. Patients showed discordant and concordant perspectives regarding data privacy, security, and confidentiality, as well as suggesting approaches to improve the use of mHealth apps (facilitators), such as protection of personal data, ensuring that health status or medical conditions are not mentioned, brief training or education on data security, and assuring data confidentiality and privacy. Similarly, awareness of the subject matter differed across the studies, suggesting the need to improve patients' awareness of data security and privacy. Older patients, those with a history of experiencing data breaches, and those belonging to the higher-income class were more likely to raise concerns about the data security and privacy of mHealth apps. These concerns were not frequent among patients with higher satisfaction levels and those who perceived the data type to be less sensitive. CONCLUSIONS: Patients expressed diverse views on mHealth apps' privacy, security, and confidentiality, with some of the issues raised affecting technology use. These findings may assist mHealth app developers and other stakeholders in improving patients' awareness and adjusting current privacy and security features in mHealth apps to enhance their adoption and use. TRIAL REGISTRATION: PROSPERO CRD42023456658; https://tinyurl.com/ytnjtmca.

Half-Normal Saline vs Normal Saline for Cavotricuspid Isthmus-Dependent Atrial Flutter Ablation.

Background: Cavotricuspid isthmus (CTI) ablation requires permanent bidirectional block to prevent recurrence of typical atrial flutter (AFL). Catheter irrigation with half-normal saline (HNS) produces larger and deeper lesions in experimental models compared with normal saline (NS). This study was performed to compare the clinical efficacy and safety of HNS vs NS irrigation for typical AFL ablation. Methods: Sixty patients undergoing catheter ablation of typical AFL were randomized 1:1 to NS or HNS irrigation. Endpoints included time to CTI block, acute reconnection, incidence of steam pops, and recurrence of AFL during follow-up. Results: Baseline characteristics were comparable between both arms. The mean age of the patients was 68.5 ± 8.2 years, 20% were female, and 32% had atrial fibrillation before being enrolled. Bidirectional CTI block was obtained in all patients with no difference in time to CTI block between groups (6.4 ± 4.4 minutes vs 7.6 ± 4.5 minutes, respectively; P = 0.15). There was a trend to less acute reconnection in the HNS group compared with NS (13.3% vs 26.6%; P = 0.46). Steam pops occurred in 4 patients using HNS vs none in the NS group, but no major complications were observed. During the follow-up, rate of AFL recurrence was similar between groups (6.7% with HNS vs 10% with NS; P = 0.5). There was no difference in time to recurrence (7.6 ± 6.9 vs 4.9 ± 4.5 months; P = 0.6). Conclusions: In this small pilot randomized controlled trial, there was no significant difference between HNS and NS for CTI ablation; however, HNS may increase the incidence of steam pops.

Contexte: Pour prévenir la récurrence d'un flutter auriculaire (flutter) typique, l'ablation de l'isthme cavotricuspidien exige un bloc de conduction bidirectionnel permanent. Dans des modèles expérimentaux, l'irrigation par cathéter au moyen d'un soluté demi-salin produit des lésions plus larges et plus profondes, comparativement à un soluté physiologique salin. La présente étude a été réalisée dans le but de comparer l'efficacité clinique et l'innocuité de l'irrigation au moyen d'un soluté demi-salin à celles de l'irrigation par un soluté physiologique salin dans les cas d'ablation d'un flutter. Méthodologie: Soixante patients soumis à une ablation d'un flutter typique par cathéter ont été répartis au hasard dans un rapport de 1:1 en deux groupes d'irrigation, soit par soluté demi-salin, soit par soluté physiologique salin. Les critères d'évaluation de l'étude étaient les suivants : temps écoulé jusqu'au bloc de l'isthme cavotricuspidien, reconnexion aiguë, jet de vapeur sonore (steam pop) et récidive de flutter durant le suivi. Résultats: Les caractéristiques initiales étaient comparables dans les deux groupes. Les patients avaient une moyenne d'âge de 68,5 ± 8,2 ans, 20 % étaient des femmes et 32 % présentaient une fibrillation auriculaire avant leur admission à l'étude. Un bloc bidirectionnel dans l'isthme cavotricuspidien a été obtenu chez tous les patients, sans différence entre les groupes en ce qui a trait au temps écoulé jusqu'à l'obtention du bloc isthmique (6,4 ± 4,4 minutes vs 7,6 ± 4,5 minutes, respectivement; p = 0,15). Une tendance vers un nombre plus faible de cas de reconnexion aiguë a été notée dans le groupe d'irrigation par soluté demi-salin, comparativement au soluté physiologique salin (13,3 % vs 26,6 %; p = 0,46). Un jet de vapeur sonore est survenu chez 4 patients recevant un soluté demi-salin contre aucun dans le groupe sous soluté physiologique salin, mais aucune complication importante n'a été relevée. Durant le suivi, le taux de récidive de flutter a été similaire dans les deux groupes (6,7 % sous soluté demi-salin vs 10 % sous soluté physiologique salin; p = 0,5). Aucune différence n'a été notée pour ce qui est du temps écoulé jusqu'à la survenue d'une récidive (7,6 ± 6,9 vs 4,9 ± 4,5 mois; p = 0,6). Conclusions: Dans cette petite étude pilote contrôlée et avec répartition aléatoire, aucune différence significative n'a été observée entre le soluté demi-salin et le soluté physiologique salin pour l'ablation de l'isthme; toutefois, le soluté demi-salin augmenterait la fréquence des cas de jet de vapeur sonore.

Electrocardiographic predictors of atrial fibrillation in patients with cryptogenic stroke.

BACKGROUND: Empiric anticoagulation is not routinely indicated in patients with cryptogenic stroke without documentation of atrial fibrillation (AF). Therefore, identification of patients at increased risk of AF from this vulnerable group is vital. OBJECTIVES: To identify electrocardiographic (ECG) predictors of AF in patients with cryptogenic stroke or transient ischemic attack (TIA) undergoing insertion of an implantable cardiac monitor (ICM). METHODS: In this single-center study, 48 patients with cryptogenic stroke or TIA had an ICM implanted for detection of AF between January 2013 and September 2019. Patients with and without AF were compared in terms of p-wave duration and a novel index (MVP score). RESULTS: During a mean follow-up of 16 ± 14 months, AF was detected in seven patients (15%). Diagnosis of AF was made after a mean of 10 ± 14 months, with time to first AF detection ranging between 1 and 40 months. Patients with AF had a longer p-wave duration (136 ± 9 ms vs. 116 ± 10 ms; p = .0001) and a higher MVP score (4.5 ± 1.2 vs. 2.0 ± 0.9, p = .0001) than those without AF. Advanced interatrial block (IAB) was observed in 43% of patients with ICM evidence of AF and 0% of those without AF (p = .002). Age, LA size or LVEF were not predictors of AF. CONCLUSION: An increased p-wave duration, advanced IAB and high MVP score are associated with AF occurrence in patients with cryptogenic stroke. Identifying patients with these markers may be helpful as they may benefit from more exhaustive and prolonged monitoring.

Deactivation of Implantable Cardioverter Defibrillator in Patients With Terminal Diagnoses.

Implantable cardioverter defibrillators (ICDs) prevent sudden cardiac death. However, in patients with terminal illnesses, these devices may disrupt the dying process. This study was undertaken to review our current strategies surrounding device deactivation. A retrospective chart review was performed at Kingston Health Sciences Centre of patients with an ICD who died from 2015 to 2018. Data collected included patient demographics, clinical details surrounding device implantation, patient co-morbidities leading to deactivation, time to deactivation, physical place of deactivation, and device programming information. Ethics approval was obtained from the Queen's University Health Sciences Research Ethics Board. A total of 49 patients were included for analysis. Mean age at the time of death was 77.5 years (range: 57 to 94 years) and 12.2% (6/49) were women. The indications for ICD implantation were primary prevention of sudden cardiac death in 69.4% (34/49) and secondary prevention in 30.6% (15/49). Deactivation as part of end-of-life care was performed in 32.7% of patients (16/49). Deactivations occurred in clinic in 6.1% (3/49) of patients, on hospital inpatient wards in 12.2% (6/49) of patients, and in critical care settings in 14.2% (7/49) of patients. The remaining 67.3% (33/49) of patients died with fully functioning devices in place. The most prevalent terminal diagnoses were metastatic cancer (22.4%) and end-stage congestive heart failure (20.4%). On average, patients had their devices deactivated 13 months (range: 0 to 62 months) after their terminal diagnosis was established. Once a patient was documented as Do Not Resuscitate (DNR), deactivation was discussed and carried out within a mean time of 38 days (range: 0 to 400 days). Seven patients had their device active for more than 1 month after being documented as DNR. Ten patients (20.4%) received ICD shocks after their terminal diagnosis, 9 received shocks in the month before death, and 2 received shocks after formal DNR orders were in place. Approximately one-third of patients with ICDs received deactivation of their cardioversion/defibrillation therapies as part of their end-of-life care plan. A relatively high proportion of patients (20%) received an ICD shock in the last month of life. In conclusion, addressing device programming needs, including deactivation of cardioversion/defibrillation therapies, should be considered in the context of a patient's goals of care in every patient with an ICD who has a co-existing life-limiting diagnosis.

Hybrid ablation under intraoperative 3D voltage mapping guidance.

Long-standing persistent atrial fibrillation remains a significant therapeutic challenge, often proving to be resistant to treatment with antiarrhythmic medications and transcatheter ablation. Hybrid ablation, which combines a minimally invasive surgical and transcatheter approach, is emerging as a promising treatment option. In this video tutorial, we demonstrate our method of hybrid ablation for long-standing persistent atrial fibrillation using advanced 3D electro-anatomical voltage mapping to guide the ablation process and thereby improve the ultimate effectiveness of the procedure.

Cardiac Implantable Electronic Devices and End-of-Life Care: An Australian Perspective.

Cardiac implantable electronic devices (pacemakers and defibrillators) are increasingly common in modern cardiology practice, and health professionals from a variety of specialties will encounter patients with such devices on a frequent basis. This article will focus on the subset of patients who may request, or be appropriate for, device deactivation and discuss the issues surrounding end-of-life decisions, along with the ethical and legal implications of device deactivation.

The predictive value of high sensitivity-troponin velocity within the first 6h of presentation for cardiac outcomes regardless of acute coronary syndrome diagnosis.

BACKGROUND: Low-range troponin elevations without clear coronary manifestations remain a major diagnostic challenge. We sought to determine if troponin velocity could allow for early identification of patients without an obvious cardiac diagnosis and who are at increased risk for cardiac-specific events. METHODS & RESULTS: All patients presenting to South Australian public hospitals between 1 September 2011 and 30 September 2012, with at least two troponin measurements during the first 6h after ED presentation were included. Diagnoses were classified as 'coronary', 'non-coronary cardiac', and 'non-cardiac' using the International Classification of Diseases 10 codes. The relationship between troponin velocity and cardiac-specific mortality and combined cardiac outcome (death and myocardial infarction) was assessed using Fine and Gray competing risk models in patients with an initial troponin <52 ng/L. Sensitivity analyses were performed using different initial and maximum troponin cut-off values. In total, 7300 patients were identified. A troponin velocity of 2.5 ng/L/h or greater in the non-cardiac (n=2793) patient group was significantly associated with an increased risk for 12-month cardiac mortality (sub-hazard ratio [SHR] 2.90, 95% CI 1.33-6.34) and combined cardiac outcome (SHR 2.08, 95% CI 1.01-4.27). This association was consistent for coronary (n=3835) and non-coronary cardiac (n=672) patient groups, and remained after sensitivity analyses. CONCLUSIONS: The significant association observed across all patient groups suggests that troponin velocity could be used for early risk stratification of patients with low-range troponin elevations without clear cardiac symptoms. These results may help guide future clinical trials aimed at assessing the utility of cardiac-targeted interventions in this challenging patient population.

High sensitivity-troponin elevation secondary to non-coronary diagnoses and death and recurrent myocardial infarction: An examination against criteria of causality.

BACKGROUND: Myonecrosis provoked by illness unrelated to unstable coronary plaque is common, but uncertainty about a cause-effect relationship with future events challenges the appropriateness of initiating therapies known to be effective in cardiac conditions. We examined the causal relationship between troponin elevation in non-coronary diagnoses and late cardiac events using the Bradford Hills criteria for causality. METHODS AND RESULTS: Patients presenting acutely to South Australian public hospitals receiving at least one troponin between September 2011-September 2012 were included. Diagnoses were classified as coronary, non-coronary cardiac and non-cardiac using the International Classification of Diseases, version 10 Australian Modified, codes. The relationship between peak in-hospital troponin, using a high-sensitivity troponin T assay and adjudicated cardiac and non-cardiac mortality, and subsequent myocardial infarction (MI) was assessed using competing-risk flexible parametric survival models. Troponin results were available for 38,161 patients of whom, 12,645 (33.6%), 3237 (8.5%), and 22,079 (57.9%) patients were discharged with coronary, non-coronary cardiac and non-cardiac diagnoses, respectively. Troponin >14 ng/l was observed in 43.6%. The relationship between troponin and cardiac mortality was stronger among the non-coronary diagnosis group (troponin 1000 ng/l: coronary hazard ratio: 5.1 (95% confidence interval (CI) 4.0-6.6) vs non-coronary hazard ratio: 16.3 (95% CI 12.6-22.4)). The temporal hazard for cardiac death was marked within 30 days in both groups. Among non-coronary diagnoses, the hazard for recurrent MI was higher but did not vary with time. CONCLUSIONS: Consistency with causal criteria between secondary myonecrosis and cardiac events suggest the potential benefit for extending cardiac specific interventions to this population if supported in trials appropriately designed to address competing risks. Troponin elevation precipitated by non-coronary events is common and demonstrates an associations with late mortality that are analogous to spontaneous MI resulting from unstable coronary plaque. These observations help inform the design of randomized clinical trials exploring the benefits and risk of therapies with established benefits in other cardiac conditions. Such studies will need to appropriately account for competing risks in this population of patients.