Artificial intelligence predictive analytics in heart failure: results of the pilot phase of a pragmatic randomized clinical trial.

OBJECTIVES: We conducted an implementation planning process during the pilot phase of a pragmatic trial, which tests an intervention guided by artificial intelligence (AI) analytics sourced from noninvasive monitoring data in heart failure patients (LINK-HF2). MATERIALS AND METHODS: A mixed-method analysis was conducted at 2 pilot sites. Interviews were conducted with 12 of 27 enrolled patients and with 13 participating clinicians. iPARIHS constructs were used for interview construction to identify workflow, communication patterns, and clinician's beliefs. Interviews were transcribed and analyzed using inductive coding protocols to identify key themes. Behavioral response data from the AI-generated notifications were collected. RESULTS: Clinicians responded to notifications within 24 hours in 95% of instances, with 26.7% resulting in clinical action. Four implementation themes emerged: (1) High anticipatory expectations for reliable patient communications, reduced patient burden, and less proactive provider monitoring. (2) The AI notifications required a differential and tailored balance of trust and action advice related to role. (3) Clinic experience with other home-based programs influenced utilization. (4) Responding to notifications involved significant effort, including electronic health record (EHR) review, patient contact, and consultation with other clinicians. DISCUSSION: Clinician's use of AI data is a function of beliefs regarding the trustworthiness and usefulness of the data, the degree of autonomy in professional roles, and the cognitive effort involved. CONCLUSION: The implementation planning analysis guided development of strategies that addressed communication technology, patient education, and EHR integration to reduce clinician and patient burden in the subsequent main randomized phase of the trial. Our results provide important insights into the unique implications of implementing AI analytics into clinical workflow.

Evaluating an Advanced Practice Provider-Managed Coronavirus Disease 2019 Deterioration Program.

Background: COVID-19 changed how healthcare systems could provide quality healthcare to patients, safely. An urban healthcare system created an advanced practice provider (APP)-managed continuous remote patient monitoring (cRPM) program. Methods: A mixed-method study design focusing on the usable and feasible nature of the cRPM program. Both APP-guided interviews and online questionnaires were analyzed. Results: There was overwhelmingly positive APP feedback utilizing the remote monitoring solution including providing quality healthcare, detecting early clinical deterioration, and desiring to adapt the solution to other acute or chronic diseases. Implications: Understanding the clinical users' feedback on usability and feasibility of cRPM highlights the significance of rapid clinical assessment, urgent care escalation and provider accessibility.

Multimodal Pain Management of Children Diagnosed with Osteogenesis Imperfecta: An Integrative Literature Review.

OBJECTIVES: The objective of this literature review was to evaluate multimodal therapies and interventions that help prevent progression and manage pain in children with OI. DESIGN: A systematic review of literature utilizing PRISMA guidelines. DATA SOURCES: The Cumulative Index to Nursing and Allied Health Literature (CINAHL) Complete, PubMed, PsycINFO, UpToDate, and ProQuest Nursing & Allied Health Source. REVIEW/ANALYSIS METHODS: Existing literature on pain management in pediatric patients diagnosed with OI was reviewed and appraised. Fifteen studies met the criteria for review. RESULTS: Results indicated that therapies addressing pain management are most effective when they use a multimodal approach that promotes bone strength, psychological support, reduces the risk of fractures, increases bone stability, and maintains physiological function. Four multimodal treatments for pain management in children with OI were identified including bisphosphonate therapy, surgical intervention, physical therapy, and psychosocial support. CONCLUSIONS: Developing a finite understanding of the utilization of multimodal therapies to manage and treat pain can assist in engineering treatments that improve the quality of life for children diagnosed with OI.

Continuous Remote Patient Monitoring in Patients With Heart Failure (Cascade Study): Protocol for a Mixed Methods Feasibility Study.

BACKGROUND: Heart failure (HF) is a prevalent chronic disease and is associated with increases in mortality and morbidity. HF is a leading cause of hospitalizations and readmissions in the United States. A potentially promising area for preventing HF readmissions is continuous remote patient monitoring (CRPM). OBJECTIVE: The primary aim of this study is to determine the feasibility and preliminary efficacy of a CRPM solution in patients with HF at NorthShore University HealthSystem. METHODS: This study is a feasibility study and uses a wearable biosensor to continuously remotely monitor patients with HF for 30 days after discharge. Eligible patients admitted with an HF exacerbation at NorthShore University HealthSystem are being recruited, and the wearable biosensor is placed before discharge. The biosensor collects physiological ambulatory data, which are analyzed for signs of patient deterioration. Participants are also completing a daily survey through a dedicated study smartphone. If prespecified criteria from the physiological data and survey results are met, a notification is triggered, and a predetermined electronic health record-based pathway of telephonic management is completed. In phase 1, which has already been completed, 5 patients were enrolled and monitored for 30 days after discharge. The results of phase 1 were analyzed, and modifications to the program were made to optimize it. After analysis of the phase 1 results, 15 patients are being enrolled for phase 2, which is a calibration and testing period to enable further adjustments to be made. After phase 2, we will enroll 45 patients for phase 3. The combined results of phases 1, 2, and 3 will be analyzed to determine the feasibility of a CRPM program in patients with HF. Semistructured interviews are being conducted with key stakeholders, including patients, and these results will be analyzed using the affective adaptation of the technology acceptance model. RESULTS: During phase 1, of the 5 patients, 2 (40%) were readmitted during the study period. The study completion rate for phase 1 was 80% (4/5), and the study attrition rate was 20% (1/5). There were 57 protocol deviations out of 150 patient days in phase 1 of the study. The results of phase 1 were analyzed, and the study protocol was adjusted to optimize it for phases 2 and 3. Phase 2 and phase 3 results will be available by the end of 2022. CONCLUSIONS: A CRPM program may offer a low-risk solution to improve care of patients with HF after hospital discharge and may help to decrease readmission of patients with HF to the hospital. This protocol may also lay the groundwork for the use of CRPM solutions in other groups of patients considered to be at high risk. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/36741.

Home Monitoring Programs for Patients Testing Positive for SARS-CoV-2: An Integrative Literature Review.

BACKGROUND: The severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) pandemic threatened to oversaturate hospitals worldwide, necessitating rapid patient discharge to preserve capacity for the most severe cases. This need, as well as the high risk of SARS-CoV-2 transmission, led many hospitals to implement remote patient monitoring (RPM) programs for SARS-CoV-2 positive patients in an effort to provide care that was safe and preserve scarce resources. OBJECTIVE: The aim of this study is to provide an integrative review of peer-reviewed literature on different RPM programs that were implemented for SARS-CoV-2 positive patients including their strengths and challenges. METHODS: A search was conducted for peer reviewed literature using PubMed, CINAHL, OVID, and Google Scholar. Peer-reviewed studies written in English or Spanish and published between 2019 and 2021 on RPM of SARS-CoV-2-positive patients were considered. Information was extracted according to a qualitative content analysis method, informed by the Comparison of Mobile Patient Monitoring Systems Framework. RESULTS: Of 57 retrieved articles, 10 publications were included. The sample sizes ranged from 75 to 48,290 and the monitoring length ranged from 7 to 30 days. Information regarding the comparison framework was summarized. Main strengths of using RPM for SARS-CoV-2 positive patients was participant acceptance, feasibility, safety, and resource conservation. Main limitations were the lack of information on patient data security measures, robust outcomes testing, and identification of the most effective biomarkers to track SARS-CoV-2 decompensation. CONCLUSION: Different RPM programs for SARS-CoV-2 were implemented, from sending home participants with a pulse oximeter and collecting readings via call to modifying existing mobile applications and sending holistic health questionnaires to participants. This review determined that RPM is beneficial to SARS-CoV-2 positive patients; however, its effectiveness can be improved by further research. Mainly, identifying what patient data are most effective at tracking SARS-CoV-2 decompensation by utilizing advanced technology already in the market.

Continuous Remote Patient Monitoring: Evaluation of the Heart Failure Cascade Soft Launch.

OBJECTIVE: We report on our experience of deploying a continuous remote patient monitoring (CRPM) study soft launch with structured cascading and escalation pathways on heart failure (HF) patients post-discharge. The lessons learned from the soft launch are used to modify and fine-tune the workflow process and study protocol. METHODS: This soft launch was conducted at NorthShore University HealthSystem's Evanston Hospital from December 2020 to March 2021. Patients were provided with non-invasive wearable biosensors that continuously collect ambulatory physiological data, and a study phone that collects patient-reported outcomes. The physiological data are analyzed by machine learning algorithms, potentially identifying physiological perturbation in HF patients. Alerts from this algorithm may be cascaded with other patient status data to inform home health nurses' (HHNs') management via a structured protocol. HHNs review the monitoring platform daily. If the patient's status meets specific criteria, HHNs perform assessments and escalate patient cases to the HF team for further guidance on early intervention. RESULTS: We enrolled five patients into the soft launch. Four participants adhered to study activities. Two out of five patients were readmitted, one due to HF, one due to infection. Observed miscommunication and protocol gaps were noted for protocol amendment. The study team adopted an organizational development method from change management theory to reconfigure the study protocol. CONCLUSION: We sought to automate the monitoring aspects of post-discharge care by aligning a new technology that generates streaming data from a wearable device with a complex, multi-provider workflow into a novel protocol using iterative design, implementation, and evaluation methods to monitor post-discharge HF patients. CRPM with structured escalation and telemonitoring protocol shows potential to maintain patients in their home environment and reduce HF-related readmissions. Our results suggest that further education to engage and empower frontline workers using advanced technology is essential to scale up the approach.

Wearable sensor derived decompensation index for continuous remote monitoring of COVID-19 diagnosed patients.

The COVID-19 pandemic has accelerated the adoption of innovative healthcare methods, including remote patient monitoring. In the setting of limited healthcare resources, outpatient management of individuals newly diagnosed with COVID-19 was commonly implemented, some taking advantage of various personal health technologies, but only rarely using a multi-parameter chest-patch for continuous monitoring. Here we describe the development and validation of a COVID-19 decompensation index (CDI) model based on chest patch-derived continuous sensor data to predict COVID-19 hospitalizations in outpatient-managed COVID-19 positive individuals, achieving an overall AUC of the ROC Curve of 0.84 on 308 event negative participants, and 22 event positive participants, out of an overall study cohort of 400 participants. We retrospectively compare the performance of CDI to standard of care modalities, finding that the machine learning model outperforms the standard of care modalities in terms of both numbers of events identified and with a lower false alarm rate. While only a pilot phase study, the CDI represents a promising application of machine learning within a continuous remote patient monitoring system.

Personalized Analytics and a Wearable Biosensor Platform for Early Detection of COVID-19 Decompensation (DeCODe): Protocol for the Development of the COVID-19 Decompensation Index.

BACKGROUND: During the COVID-19 pandemic, novel digital health technologies have the potential to improve our understanding of SARS-CoV-2 and COVID-19, improve care delivery, and produce better health outcomes. The National Institutes of Health called on digital health leaders to contribute to a high-quality data repository that will support researchers to make discoveries that are otherwise not possible with small, limited data sets. OBJECTIVE: To this end, we seek to develop a COVID-19 digital biomarker for early detection of physiological exacerbation or decompensation. We propose the development and validation of a COVID-19 decompensation Index (CDI) in a 2-phase study that builds on existing wearable biosensor-derived analytics generated by physIQ's end-to-end cloud platform for continuous physiological monitoring with wearable biosensors. This effort serves to achieve two primary objectives: (1) to collect adequate data to help develop the CDI and (2) to collect rich deidentified clinical data correlating with outcomes and symptoms related to COVID-19 progression. Our secondary objectives include evaluation of the feasibility and usability of pinpointIQ, a digital platform through which data are gathered, analyzed, and displayed. METHODS: This is a prospective, nonrandomized, open-label, 2-phase study. Phase I will involve data collection for the digital data hub of the National Institutes of Health as well as data to support the preliminary development of the CDI. Phase II will involve data collection for the hub and contribute to continued refinement and validation of the CDI. While this study will focus on the development of a CDI, the digital platform will also be evaluated for feasibility and usability while clinicians deliver care to continuously monitored patients enrolled in the study. RESULTS: Our target CDI will be a binary classifier trained to distinguish participants with and those without decompensation. The primary performance metric for CDI will be the area under the receiver operating characteristic curve with a minimum performance criterion of ≥0.75 (α=.05; power [1-ß]=0.80). Furthermore, we will determine the sex or gender and race or ethnicity of the participants, which would account for differences in the CDI performance, as well as the lead time-time to predict decompensation-and its relationship with the ultimate disease severity based on the World Health Organization COVID-19 ordinal scale. CONCLUSIONS: Using machine learning techniques on a large data set of patients with COVID-19 could provide valuable insights into the pathophysiology of COVID-19 and a digital biomarker for COVID-19 decompensation. Through this study, we intend to develop a tool that can uniquely reflect physiological data of a diverse population and contribute to high-quality data that will help researchers better understand COVID-19. TRIAL REGISTRATION: ClinicalTrials.gov NCT04575532; https://www.clinicaltrials.gov/ct2/show/NCT04575532. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27271.

Lack of Diagnosis and Screening for Pediatric Obesity in the Retail Health Setting: Implications for Quality Improvement Measures.

INTRODUCTION: Pediatric obesity has reached an epidemic status. The purpose of this study was to examine the prevalence of overweight and obesity in patients and how often and how accurately a diagnosis was coded. The population for this study included children aged 3-18 years. This cohort presented to retail health clinics in a large urban health system for school or sports physicals from June 1, 2017, to November 30, 2017. METHOD: A retrospective chart review was conducted. Statistical analysis was performed to determine if there was a relationship between obesity and age, ethnicity, race, and sex. RESULTS: The study identified that 15.9% of patients were overweight and 16.5% were obese. In practice, 99% of patients lacked a formal diagnosis of overweight or obesity; in addition, appropriate screening measures reflecting nutrition and physical activity were found to be lacking in 99% of cases. DISCUSSION: Strategies are needed to improve efforts to diagnose and manage overweight and obesity in pediatric population in the retail health setting. Organizational recommendations for change are suggested based on guidelines for childhood obesity.

Remote Patient Monitoring in Adults Receiving Transfusion or Infusion for Hematological Disorders Using the VitalPatch and accelerateIQ Monitoring System: Quantitative Feasibility Study.

BACKGROUND: Frequent vital sign monitoring during and after transfusion of blood products and certain chemotherapies or immunotherapies is critical for detecting infusion reactions and treatment management in patients. Currently, patients return home with instructions to contact the clinic if they feel unwell. Continuous monitoring of vital signs for hematological patients treated with immunotherapy or chemotherapy or receiving blood transfusions using wearable electronic biosensors during and post treatment may improve the safety of these treatments and make remote data collection in an outpatient care setting possible. OBJECTIVE: This study aimed to evaluate patient experiences with the VitalPatch wearable sensor (VitalConnect) and to evaluate the usability of data generated by the physIQ accelerateIQ monitoring system for the investigator and nurse. METHODS: A total of 12 patients with hematological disorders receiving red blood cell transfusions, an intravenous (IV) proteasome inhibitor, or an IV immunotherapy agent were included in the study and wore the VitalPatch for 12 days. Patients completed questionnaires focusing on wearability and nurses completed questionnaires focusing on the usability of the VitalPatch. RESULTS: A total of 12 patients were enrolled over 9 months, with 4 receiving red blood cell transfusions, 4 receiving IV proteasome inhibitors, and 4 receiving IV immunotherapy. These patients were treated for diseases such as multiple myeloma, myelodysplastic syndrome, and non-Hodgkin lymphoma. Of these patients, 83% (10/12) were aged 60 years and older. A total of 4 patients (4/12, 33%) withdrew from the study (3 because of skin irritation and 1 because of patch connection issues). Patients wore biosensor patches at baseline and for 1-week post administration. Patient-reported outcomes (PROs) were collected at baseline, day 1, day 5, and day 8. No difference in the PRO was observed when nurses or patients applied the patch. PRO data indicated minimal impact on the patient's life. Ease of use, influence on sleep, impact on follow-up of health, or discomfort with continuous monitoring did not change between baseline and day 8. Changes in PRO were observed on day 5, where a 20% (2/10) increase in skin irritation was reported. Withdrawals because of skin irritation were reported in all cases when wearing the second patch. Nurses reported the placement of the VitalPatch to be easy and felt measurements to be reliable. CONCLUSIONS: Generally, the VitalPatch was well tolerated and shown to be an attractive device because of its wearability and low impact on daily activities in patients, therefore making it suitable for implementation in future studies.

Appropriate Classification and Filtering of Electromagnetic Interference by the S-ICD Sensing Algorithm During Surgery.

The subcutaneous implantable cardioverter defibrillator (S-ICD) is a new device used for the prevention of sudden cardiac death. Best practices in the perioperative management of the S-ICD are not established; therefore, clinicians typically deactivate the device during surgery, with reinterrogation and activation postoperatively. This could put the patient at risk for being discharged with the device "off." We present two cases where electromagnetic interference was appropriately detected by the S-ICD and filtered. These cases present an important clinical finding that could lead to less deactivation of devices during surgery. Further research will be required to define which surgical procedures require magnet, reprogramming, or no changes.

Understanding Determinants of Cardiovascular Health in a Mexican American Community.

Cardiovascular disease (CVD) is the leading cause of death in Hispanic Americans. Social and physical determinants of health unique to this community must be understood before interventions can be designed and implemented. This article describes a CVD risk assessment conducted in a primarily Mexican American community, using Healthy People 2020 as a model. Social (language, culture, awareness of CVD, and socio-economic status) and physical (presence and use of recreation areas, presence of grocery stores, public transportation, and environmental pollution) determinants of health as well as access to health services were assessed. Fifteen community leaders were interviewed using guided interviews. Database searches and direct observations were conducted. Using these methods provided comprehensive assessment of social and physical determinants of health, and access issues that were unique to the community studied. Findings demonstrated greater awareness of diabetes than CVD as a health problem, with little knowledge of CVD risk factors. Lack of access to health services (lack of insurance, lack of a medical home) and presence of cultural and socioeconomic barriers such as language, unemployment, low income, and lack of insurance were identified. The physical determinants such as environment presented fewer barriers, with adequate access to fruits and vegetables, transportation, and parks. Results revealed target areas for intervention.

ICD-ON Registry for Perioperative Management of CIEDs: Most Require No Change.

BACKGROUND: There is significant variability in the perioperative management of patients with cardiac implanted electronic devices (CIEDs) undergoing procedures requiring electrosurgery. METHODS: We performed a multicenter registry from February 2014 to August 2015 at three suburban Chicago hospitals. Patients with transvenous CIEDs undergoing procedures requiring electrosurgery were assigned to one of three groups: (1) reprogram, (2) magnet, or (3) no change. Subjects with implantable cardioverter defibrillators (ICDs) or those pacemaker dependent having surgical procedures within 6 inches of their CIED were assigned to the reprogram group, whereby ICD therapies were programmed off with asynchronous pacing if pacemaker dependent. Subjects with ICDs ≥ 6 inches from their surgical site but above the iliac crest were assigned to the magnet group. All others were in the no change group. We evaluated electromagnetic interference (EMI) and postoperative device reset based on surgical location. RESULTS: All patients (n = 331) had pectoral CIEDs with mean age 73 years, 65% male, ejection fraction 56% for pacemaker subjects, 35% for ICD subjects with 22% pacemaker dependent. Assignments were n = 52 (16%) reprogram group, n = 51 (15%) magnet group, and n = 228 (69%) no change. There was EMI in 45% of thoracic cases, 35% of head/neck, 15% of upper extremity, and 3% of abdominal cases above iliac crest. There was no EMI in procedures below the iliac crest. There were no inappropriate therapies or device reset. CONCLUSION: Results of the ICD-ON protocol demonstrate safe and efficient management of patients with CIEDs based on electrosurgery location, with 69% requiring no reprogramming or magnet application.

Experiences of Young Adults With Pacemakers and/or Implantable Cardioverter Defibrillators.

BACKGROUND: The number of implanted devices (pacemakers [PMs] and implantable cardioverter defibrillators [ICDs]) is increasing. Because of technological advances, these devices are used in greater numbers in children and adolescents. Challenges of having these devices have been well studied in adults, but little is known about the lived experiences from the perspective of young adults. OBJECTIVE: This study explored the lived experiences, coping behaviors, and challenges of young adults who had cardiac devices implanted during childhood. METHODS: A descriptive qualitative study design was used. Purposive sampling was used to identify young adults aged 18 to 29 years, living with a PM and/or ICD. Participants were interviewed about their experiences and challenges related to living with a PM or ICD, with common themes identified and analyzed. RESULTS: A total of 6 participants were interviewed for this study. The challenges of living with a PM and/or ICD included insecurity about physical appearance, device compliance, physical sensations of the device, future uncertainty, and limited support. The identified coping behaviors utilized by the participants were confrontation, acceptance, educating others, spreading awareness, avoidance, and humor. The overall lived experiences described were appreciation for device benefits, fear of device malfunction, and attracting attention. CONCLUSIONS: The lived experiences of young recipients often mirror that of older adults; however, it is clear that there are challenges and coping behaviors unique to young adults living with a PM and/or ICD. It is important to educate healthcare providers about the unique challenges that young adults may face so they can provide the appropriate support to this population.

Randomized controlled trial of perioperative ICD management: magnet application versus reprogramming.

BACKGROUND: There are insufficient data to guide perioperative implantable cardioverter-defibrillator (ICD) management for patients undergoing surgical procedures using electrocautery. METHODS: We conducted a multicenter randomized controlled trial of patients with ICDs undergoing surgery with monopolar electrocautery. Subjects were randomized to an "Off" group (ICD therapy programmed off, then postoperatively programmed on) or a "Magnet" group (ICD therapy suspended with a magnet and no immediate postoperative ICD interrogation). Also, a registry was maintained of ICD patients with procedures within 6 inches of the ICD (all programmed off). The primary endpoint was ICD off time with secondary endpoints being caregiver handoffs and incidence of electromagnetic interference (EMI). RESULTS: All patients (n = 80) had pectoral ICDs. Subject demographics were well matched in each group, and duration of electrocautery was similar (80 minutes vs 64 minutes, P = 0.58). The mean "excess" ICD off time (ICD off time - electrocautery time) was significantly higher in the Off group than the Magnet group (115 minutes vs 28 minutes, P < 0.001). Mean number of caregiver handoffs were higher in the Off group (6.6 vs 5.5, P < 0.001). There was no EMI in any lower abdominal or lower extremity procedures. Neither group had arrhythmic events or device reset. CONCLUSION: A magnet protocol simplifies perioperative ICD management for procedures using electrocautery more than 6 inches from the ICD. This protocol results in significantly shorter time with ICD therapy off, fewer provider handoffs, no risk of inadvertently discharging patients home with ICD therapies off, and no device reset.

Botulinum toxin a can positively impact first impression.

BACKGROUND First impression is influenced by facial appearance and improved by cosmetic surgery. OBJECTIVE We wanted to determine if treatment with botulinum toxin A (BTxnA) would improve first impression. MATERIALS AND METHODS Women received BTxnA in the forehead. Photos were taken prior to, and 1 week after, final BTxnA injection in smiling and relaxed poses. Photos were divided into books with each subject represented only once. Evaluators completed a survey rating first impression on various measures of success for each photo. RESULTS No differences were seen for social skills, financial, or relationship success scales. A significant decrease in first impression scores between treatment photos was seen for academic performance and occupational success. However, analysis of between-subject effects found that "smile/relax" accounted for the decreased score in both scales. Significant increases in first impression scores were seen for dating success, attractiveness, and athletic success scales where smile/relax and BTxnA contributed significantly to the improved scores. CONCLUSIONS BTxnA improved first impression scores for dating success, attractiveness, and athletic success scales. Academic performance and occupational success scores were not affected by BTxnA when the smile/relax variable was included. The smile/relax variable was a more important predictor for academic performance and occupational success scores.

The association of diabetes and older age with the absence of chest pain during acute coronary syndromes.

Cardiac autonomic neuropathy associated with diabetes can cause silent myocardial ischemia and may influence the way that patients perceive symptoms of acute coronary syndromes (ACS). The purpose of this study was to examine symptoms of ACS in patients with and without diabetes while controlling for length of time with diabetes. A convenience sample of 256 patients from two large medical centers in the Midwest participated. Patients with diabetes comprised 33.2% of the sample and reported significantly less chest pain and more unusual fatigue. Patients with diabetes of longer duration (10 or more years) reported more difficulty breathing than did patients with diabetes of shorter duration (fewer than 10 years). Older patients with the same diabetes status also reported less chest pain. For older patients and for patients with diabetes, lack of chest pain during ACS could delay treatment and is thus a concern.