Expert Review of Medical Devices
ISSN: 1743-4440 (Print) 1745-2422 (Online) Journal homepage: http://www.tandfonline.com/loi/ierd20
Patient experience with a novel patch-like external loop recorder for cardiac arrhythmia detection in India Maneesh Shrivastav, Sanjay Padte & Nakul Sinha To cite this article: Maneesh Shrivastav, Sanjay Padte & Nakul Sinha (2014) Patient experience with a novel patch-like external loop recorder for cardiac arrhythmia detection in India, Expert Review of Medical Devices, 11:3, 259-264 To link to this article: http://dx.doi.org/10.1586/17434440.2014.894457
Published online: 28 Mar 2014.
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Date: 10 November 2015, At: 12:58
Special Report
Patient experience with a novel patch-like external loop recorder for cardiac arrhythmia detection in India Downloaded by [University of Florida] at 12:58 10 November 2015
Expert Rev. Med. Devices 11(3), 259–264 (2014)
Maneesh Shrivastav*1, Sanjay Padte2 and Nakul Sinha3 1 Medtronic Inc., 8200 Coral Sea Street NE MVC44, Mounds View, MN 55112, USA 2 Medtronic Inc., Mumbai, India 3 Sahara Hospital, Lucknow, India *Author for correspondence: [email protected]
Cardiovascular disease (CVD) is reaching pandemic proportions in India. The effects of CVD are disastrous for the Indian economy as the disease strikes in the prime working ages of the labor force. The great need for therapeutic and diagnostic options combined with pressure on cost containment place emphasis on the development of low cost, credible, point of care diagnostic tools to pinpoint issues in cardiac health for the Indian consumer. A previous study of 125 patients in India examined a novel external loop recorder (ELR) for ambulatory ECG monitoring with high yield and compliance. The current study probes the patient experience, inclusive of patient comfort, ease of use, clarity of the diagnostic report, and value of the ELR. The analysis shows that 85% found this ELR comfortable to wear and deploy, 77% responded with no challenges with the use of this ELR, 60% mentioned they were inclined to seek treatment after this ELR was deployed, and 60% found good value in the device. The results indicate that this particular ELR is a high performing device with excellent patient satisfaction, indicating that the device is a suitable tool for diagnosis of cardiac arrhythmia in India. KEYWORDS: arrhythmia • diagnosis • ECG • ELR • external loop recorder • India • pacemaker • patient experience
According to the WHO, the largest cause of death and disability in India by 2020 would be cardiovascular disease. Indian patients under age 40 affected by such ailments have increased from 10 to 30% in the last decade [1]. The reduction in age for those affected by cardiovascular disease can have devastating effects as it hits the prime age of the labor force. Between 2005 and 2015, India is projected to lose 1% of its GDP due to heart disease, stroke and diabetes, amounting to approximately US$236 billion [2]. The Indian patient is cost conscious in a self-pay, limited health insurance coverage and low medical reimbursement environment. The great need for therapeutic and diagnostic options combined with the pressure on costs places emphasis on the development of lowcost, credible, point-of-care diagnostic tools to pinpoint issues in cardiac health for the Indian consumer. A previous study examined the use of a novel, affordable and effective external loop recorder (ELR) for the diagnosis of potentially life-threatening cardiac arrhythmia [3]. informahealthcare.com
10.1586/17434440.2014.894457
The device had diagnostic yield of 38% for clinically significant arrhythmia and 80% when a broader range of arrhythmia were included. The patient compliance was 98% [3]. A patient was noted as being compliant if he/she did not remove the patch prior to the end of the prescribed monitoring period. This article examines the ELR used in the previous study from a patient’s perspective in terms of comfort, ease of use, clarity of the report and value. Methods
One hundred twenty five patients (62.5 ± 16.7 years, 61% male) who were included in a previous study [3] with the ELR were interviewed via telephone to ascertain their satisfaction and experience. Informed consent for feedback was received from each patient at the time of ELR deployment. Patient experience with the NuvantÒ Mobile Cardiac Telemetry System (Corventis Inc., St. Paul, MN, USA) was assessed in this study. This device is described in detail in other publications [3–6]
Ó 2014 Informa UK Ltd
ISSN 1743-4440
259
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comfortable to wear and deploy. Patients commented that the contouring nature of the patch (facilitated by the fabric outer cover and the flexible electronics) fits nicely on their skin and does not inhibit normal arm motion. Furthermore, patients responded that the patch was comfortable to wear in high humidity conditions (typical in India) or during times of excessive perspiration. Figure 1. The NuvantÒ Mobile Cardiac Telemetry System used in this study. Patients were questioned whether Ò (A) Piix patch; (B) zLink transmitter. they faced any obstacles during the prescription period. This question was and is shown in FIGURE 1. In brief, the system consists of a wire- open-ended, allowing respondents to describe in detail. The less, two-electrode patch-like device with an adhesive backing results are shown in FIGURE 3. Seventy four of 96 individuals that is applied on the chest, diagonally to the left of the ster- (77%) responded that there were no challenges with the num. A small transmitter is worn on the patient’s belt or kept ELR. A fraction (17%) mentioned that the skin felt irritated nearby. The patch can be worn for 7 days and may be replaced at some point during the period. Three people (3%) with another patch for another 7-day extension. Upon detec- responded that they had difficulty bathing despite the watertion of an arrhythmia, the ECG is sent to a monitoring station resistant nature of the product (product is approved for use staffed with ECG-trained technicians. A diagnostic report with while showering). the resulting analysis is given to the patient’s physician at the The clarity and ease of understanding of the patient endend of the prescription period. The physician then notifies or of-use (EOU) report was also examined. The EOU report consults the patient and delivers the report to the patient. consists of the average heart rate histogram, sample ECGs of Some of the interview questions were open-ended (free each recorded event and the diagnosis for each epoch as answer), while others were multiple-choice-based on a Likert noted by the qualified technician. Final analysis, rhythm deciscale. The questions probed the patient’s comfort with the sion changes (if any) and recommended treatments are left patch, any obstacles faced, ease of understanding the diagnostic for the prescribing doctor. The results of the readability and report, motivation for treatment and value of the ELR. ease-of-understanding assessments are shown in FIGURE 4. Fifty five percent of respondents noted that it was easy or very easy Results to read and understand. A typical report had Flesch–Kincaid Patients were asked to assess their comfort level during appli- grade level of 11.1 and a Flesch–Kincaid reading ease score cation of the ELR and during the monitoring period. The of 42.2. results are shown in FIGURE 2. Five percent of patients found Patients were very motivated to find a diagnosis for the ELR very uncomfortable or uncomfortable, 2% were neu- their ailment. After the ELR was deployed and the EOU tral, 8% found it comfortable and 85% found the ELR very report was delivered via their physician, 43 patients (60% of B
100 90 80 70 Patients (n)
Downloaded by [University of Florida] at 12:58 10 November 2015
A
60 50 40 30 20 10 0
Fitting (n = 96) Monitoring (n = 86)
Very Uncomfortable uncomfortable 0 6
0 3
Neutral
Comfortable
Very comfortable
1 3
4 10
91 64
Figure 2. Distribution of patients’ experience with fitting and monitoring using the external loop recorder.
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Patient experience with a novel patch-like external loop recorder
Others
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1
Taking a bath
3
Skin irritation
16 74
No obstacles 0
10
20
30 40 50 Number of responses
60
70
80
72 respondents) mentioned that they were inclined or highly inclined to seek treatment. Sixty percent of patients (n = 82) also noted that they found good value in the ELR. The ELR also recorded high-fidelity ECGs with good detail (sampling frequency is 200 Hz with 10-bit resolution). An example of the ECG is shown in FIGURE 5. The report includes a daily average heart rate graph, a summary of each recorded episode with trigger type (auto or manual) and 6-s epochs of each recorded event. Expert commentary
of the device and the ability to shower were lauded by both patients and doctors as the major reasons for the high compliance during the monitoring period. This experience was pervasive among gender and various body weights (obese and thin patients alike). Furthermore, the automatic transmissions of arrhythmic events captured by the patch circumvented any need for the patient to manually transmit events to the staffed monitoring center. An important factor contributing to this comfort and snug adhesion of the patch is the cleanliness of the skin and removal of excess body hair from the site. Deviation from the instructions for use of the device can adversely affect patient comfort and device performance. Female patients particularly appreciated the small form factor which allowed for inconspicuous placement under clothing, as shown in FIGURE 6. The ELR can be completely hidden under loose Indian clothing such as a salwar or sari. Patient convenience also contributed to high-performance attributes. The auto-triggering mechanism of the ELR avoided complicated procedures for patient activation. Furthermore, when a patient is symptomatic, he/she may be preoccupied with the management of the acute situation, or may be unable to activate the device due to incapacitation (i.e., during syncope). One point of inconvenience may be the misplacement of the magnet necessary for patient triggering. The latest generation of the Nuvant device eliminates the need for a magnet.
This study examined the patient experience with the NuvantÒ Mobile Cardiac Telemetry System, with a broad lens of attributes that contribute to patient satisfaction. A negative experience with a treatment regimen can adversely affect patient compliance and render an otherwise effective strategy to an act of futility. The consequence of non-adherence, whether it is not following a doctor’s advice, disregarding a treatment regimen or not following a diagnostic procedure can be devastating. In the US, non-adherence can cost billions [7]. The indirect costs of non-compliance include poor health outcomes and in extreme cases death [8]. In the case of ambulatory cardiac diagnostics, the price of non-compliance could mean missing a dangerous arrhythmia. The cardiac diagnostic tool represented in this article represents the first step toward an efficacious therapy. Consistent with a previous study in which patient compliance was 98% [3], the results of 25 the patient experience were also promis33% ing. One study with a different mobile 20 24% cardiac outpatient telemetry device dem22% 15 onstrated a 53% general patient compli16% ance score and only 42% compliance 10 with scheduled (patient initiated) rhythm 5% 5 transmission [9]. In that study, typical reasons for failure to comply included rash 0 Very difficult Difficult Neutral Easy Very easy produced at the site of the electrode. 14 21 #Responses 15 10 3 Other general complaints can include discomfort due to wires or large form factor Patient responses device or inability to shower with the Figure 4. Patient reaction to the readability and ease of understanding of the device. In the current study with the end-of-use report (n = 63). Nuvant device, the small, wireless nature Patients (n)
Downloaded by [University of Florida] at 12:58 10 November 2015
Figure 3. Obstacles faced during the external loop recorder monitoring period (n = 94).
informahealthcare.com
261
Figure 5. Example end-of-use report.
Downloaded by [University of Florida] at 12:58 10 November 2015
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262 Shrivastav, Padte & Sinha
Expert Rev. Med. Devices 11(3), (2014)
Patient experience with a novel patch-like external loop recorder
Collarbone
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Collarbone Collarbone
Sternum
Sternum
Sternum
Male
Female
Female (petite)
Downloaded by [University of Florida] at 12:58 10 November 2015
Figure 6. The external loop recorder is placed inconspicuously on the chest using its self-adhesive backing.
Various other metrics denoted a positive patient experience. The outcome of 60% of patients being motivated to seek a treatment after the use of the ELR, and 60% of patients finding value in the device, further indicates a positive experience. Reading ease of the EOU report was mixed, with 55% easy/very easy and 40% difficult/very difficult. This result is not surprising since the EOU contains technical information. The Flesch–Kincaid score indicates that the text should be understandable by an 11th grade student. The difficulty in technical interpretation of reports was mitigated by the doctor’s consultation appointment in which the results of the monitoring report were explained to the patient. Good patient–doctor communication about the ambulatory monitoring device contributed to a positive patient experience. This result corroborates well with a separate study with an ambulatory blood pressure monitoring device in which the physician’s effectiveness in explaining the need and results of the ambulatory monitoring was linked to the patient’s perception of the diagnostic exam [10]. The same is true of the current study. Patients generally believed that the results are helpful in making treatment decisions. Finally, an in-country, local language-speaking customer service center also proactively helped patients with prescriptions which also increased patient satisfaction. In the rare case that the patient needs assistance during the monitoring period, the local customer service center called the patients or vice versa. Results from other studies have corroborated that clinically focused customer service initiatives in healthcare can substantially improve patients’ perception of quality and outcome [11]. Conclusion
For many patients with infrequent arrhythmias, the lack of a diagnosis can be a frustrating issue, as shown by the high patient motivation metrics in this study. Though satisfaction and comfort with the ELR improved compliance, overall patient satisfaction is a combination of clear and effective communication between the patient and physician in the context of the local culture, understanding of the diagnostic regimen and a common understanding of the goals. Patient
informahealthcare.com
satisfaction can have a dramatic effect on compliance and can impact the care pathway and diagnostic yield. Successful diagnostic strategies early in the pathway can lead to greater patient benefits. Long-term follow-up of patients who have undergone ambulatory monitoring, for example, has shown a reduction in syncopal events (when appropriate therapy is pursued) and a general improvement in quality of life [12]. In the final analysis, the ELR represents a cost-effective, high-yielding methodology for properly selected patients who suffer from arrhythmias [13]. Five-year review
Advances in medical devices are resulting in devices that are smaller, lighter and easier to use. Specifically for external cardiac diagnostic devices, the last decade has seen an evolution from bulky, wired, patient-triggered event recorders with nonlooping memory to compact mobile cardiac telemetry and ELRs that are simple and easy to use. From a patient perspective, advances in physical and electronic features that further minimize the impact to daily activities are likely. These include improvements in ease of use through simpler user interfaces that may interface with a smartphone. Such technology is already being explored for atrial fibrillation screening [14]. Further advancements in diagnostic sophistication are also likely to improve the physician’s ability to diagnose an arrhythmia. These may include enhanced artifact reduction, larger memory capacity and physical attributes to lengthen the monitoring period while maintaining patient comfort. Furthermore, concomitant with technological advances would be patient-centric educational materials. With medical devices such as the ELR described herein proliferating previously underserved healthcare markets like India, educational and awareness materials in multiple languages and media would need to be developed. Acknowledgements
The authors thank Paul Ziegler for assistance in the review of this manuscript. Authors acknowledge the assistance of Chidambar Joshi, Murali Srivathsa, John Russell, Saurin Shah, and the HHFA and sales team in contributing to a positive patient experience.
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Financial & competing interests disclosure
M Shrivastav and S Padte are employees of Medtronic Inc. N Sinha is a prescriber of the ELR described herein. The authors have no other relevant affiliations or financial involvement with any organization or entity with
a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.
Key issues • This study assesses the patient experience from a 125-patient pilot study using a novel 7-day external loop recorder for cardiac arrhythmia detection in India. • A positive experience can have a dramatic impact on patient compliance, diagnostic yield and the appropriate care pathway. • 85% of patients found the external loop recorder very comfortable to wear and deploy. This was mainly attributable to the small form factor, ability to shower with the device and its wireless nature.
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1.
2.
3.
4.
5.
Ians. More Indian youth suffering from heart diseases. In: Times of India; Times Group, Mumbai, India; 2012
6.
Leeder S, Raymond S, Greenberg H. Race against Time. In: The Challenge of Cardiovascular Disease in Developing Economies; Columbia University & University of Sydney;2004
Padte S, Patil K, Shrivastav M. Innovative technology applications for cardiac arrhythmia diagnosis in India. In: IEEE Healthcare Innovation Conference; IEEE, Houston, TX, USA;2012
7.
DiMatteo MR. Evidence-based strategies to foster adherence and improve patient outcomes. JAAPA 2004;17(11):18-21
Shrivastav M, Padte S, Arora V, Biffi M. Pilot evaluation of an integrated monitor-adhesive patch for long-term cardiac arrhythmia detection in India. Expert Rev Cardiovasc Ther 2014;12(1): 25-35
8.
Shrivastav M, Padte S, Choudhury M, Patil K. Point of care technologies for cardiac patients in rural India. In: IEEE Engineering in Medicine and Biology Conference on Point-of-Care Healthcare Technologies; IEEE, Bangalore, India;2013
9.
Shrivastav M, Padte S, Joshi C, Patil K. A 125 patient pilot study for ambulatory
10.
264
monitoring in a primary care setting in the United States: a cross-sectional survey. BMC Fam Pract 2003;4:15
ECG monitoring using a wireless ELR in India. In: Asia Pacific Heart Rhythm Society. Taiwan;2012
References
Martin LR, Williams SL, Haskard KB, DiMatteo MR. The challenge of patient adherence. Ther Clin Risk Manag 2005; 1(3):189-99 Vasamreddy CR, Dalal D, Dong J, et al. Symptomatic and asymptomatic atrial fibrillation in patients undergoing radiofrequency catheter ablation. J Cardiovasc Electrophysiol 2006;17(2): 134-9 Ernst ME, Bergus GR. Favorable patient acceptance of ambulatory blood pressure
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Mayer TA, Cates RJ, Mastorovich MJ, Royalty DL. Emergency department patient satisfaction: customer service training improves patient satisfaction and ratings of physician and nurse skill. J Healthc Manag 1998;43(5):427-40.discussion 441-422
12.
Schickendantz S, Pillekamp F, Emmel M, et al. Wireless Holter transmission in suspected dysrhythmias. J Electrocardiol 2006;39(4 Suppl):S54-6
13.
Shrivastav M, Shrivastav R, Makkar J, Biffi M. Patient selection for ambulatory cardiac monitoring in the Indian healthcare environment. Heart Asia 2013;5(1):112-19
14.
Lau JK, Lowres N, Neubeck L, et al. iPhone ECG application for community screening to detect silent atrial fibrillation: A novel technology to prevent stroke. Int J Cardiol 2013;165(1):193-4
Expert Rev. Med. Devices 11(3), (2014)
ISSN: 1743-4440 (Print) 1745-2422 (Online) Journal homepage: http://www.tandfonline.com/loi/ierd20
Patient experience with a novel patch-like external loop recorder for cardiac arrhythmia detection in India Maneesh Shrivastav, Sanjay Padte & Nakul Sinha To cite this article: Maneesh Shrivastav, Sanjay Padte & Nakul Sinha (2014) Patient experience with a novel patch-like external loop recorder for cardiac arrhythmia detection in India, Expert Review of Medical Devices, 11:3, 259-264 To link to this article: http://dx.doi.org/10.1586/17434440.2014.894457
Published online: 28 Mar 2014.
Submit your article to this journal
Article views: 44
View related articles
View Crossmark data
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ierd20 Download by: [University of Florida]
Date: 10 November 2015, At: 12:58
Special Report
Patient experience with a novel patch-like external loop recorder for cardiac arrhythmia detection in India Downloaded by [University of Florida] at 12:58 10 November 2015
Expert Rev. Med. Devices 11(3), 259–264 (2014)
Maneesh Shrivastav*1, Sanjay Padte2 and Nakul Sinha3 1 Medtronic Inc., 8200 Coral Sea Street NE MVC44, Mounds View, MN 55112, USA 2 Medtronic Inc., Mumbai, India 3 Sahara Hospital, Lucknow, India *Author for correspondence: [email protected]
Cardiovascular disease (CVD) is reaching pandemic proportions in India. The effects of CVD are disastrous for the Indian economy as the disease strikes in the prime working ages of the labor force. The great need for therapeutic and diagnostic options combined with pressure on cost containment place emphasis on the development of low cost, credible, point of care diagnostic tools to pinpoint issues in cardiac health for the Indian consumer. A previous study of 125 patients in India examined a novel external loop recorder (ELR) for ambulatory ECG monitoring with high yield and compliance. The current study probes the patient experience, inclusive of patient comfort, ease of use, clarity of the diagnostic report, and value of the ELR. The analysis shows that 85% found this ELR comfortable to wear and deploy, 77% responded with no challenges with the use of this ELR, 60% mentioned they were inclined to seek treatment after this ELR was deployed, and 60% found good value in the device. The results indicate that this particular ELR is a high performing device with excellent patient satisfaction, indicating that the device is a suitable tool for diagnosis of cardiac arrhythmia in India. KEYWORDS: arrhythmia • diagnosis • ECG • ELR • external loop recorder • India • pacemaker • patient experience
According to the WHO, the largest cause of death and disability in India by 2020 would be cardiovascular disease. Indian patients under age 40 affected by such ailments have increased from 10 to 30% in the last decade [1]. The reduction in age for those affected by cardiovascular disease can have devastating effects as it hits the prime age of the labor force. Between 2005 and 2015, India is projected to lose 1% of its GDP due to heart disease, stroke and diabetes, amounting to approximately US$236 billion [2]. The Indian patient is cost conscious in a self-pay, limited health insurance coverage and low medical reimbursement environment. The great need for therapeutic and diagnostic options combined with the pressure on costs places emphasis on the development of lowcost, credible, point-of-care diagnostic tools to pinpoint issues in cardiac health for the Indian consumer. A previous study examined the use of a novel, affordable and effective external loop recorder (ELR) for the diagnosis of potentially life-threatening cardiac arrhythmia [3]. informahealthcare.com
10.1586/17434440.2014.894457
The device had diagnostic yield of 38% for clinically significant arrhythmia and 80% when a broader range of arrhythmia were included. The patient compliance was 98% [3]. A patient was noted as being compliant if he/she did not remove the patch prior to the end of the prescribed monitoring period. This article examines the ELR used in the previous study from a patient’s perspective in terms of comfort, ease of use, clarity of the report and value. Methods
One hundred twenty five patients (62.5 ± 16.7 years, 61% male) who were included in a previous study [3] with the ELR were interviewed via telephone to ascertain their satisfaction and experience. Informed consent for feedback was received from each patient at the time of ELR deployment. Patient experience with the NuvantÒ Mobile Cardiac Telemetry System (Corventis Inc., St. Paul, MN, USA) was assessed in this study. This device is described in detail in other publications [3–6]
Ó 2014 Informa UK Ltd
ISSN 1743-4440
259
Special Report
Shrivastav, Padte & Sinha
comfortable to wear and deploy. Patients commented that the contouring nature of the patch (facilitated by the fabric outer cover and the flexible electronics) fits nicely on their skin and does not inhibit normal arm motion. Furthermore, patients responded that the patch was comfortable to wear in high humidity conditions (typical in India) or during times of excessive perspiration. Figure 1. The NuvantÒ Mobile Cardiac Telemetry System used in this study. Patients were questioned whether Ò (A) Piix patch; (B) zLink transmitter. they faced any obstacles during the prescription period. This question was and is shown in FIGURE 1. In brief, the system consists of a wire- open-ended, allowing respondents to describe in detail. The less, two-electrode patch-like device with an adhesive backing results are shown in FIGURE 3. Seventy four of 96 individuals that is applied on the chest, diagonally to the left of the ster- (77%) responded that there were no challenges with the num. A small transmitter is worn on the patient’s belt or kept ELR. A fraction (17%) mentioned that the skin felt irritated nearby. The patch can be worn for 7 days and may be replaced at some point during the period. Three people (3%) with another patch for another 7-day extension. Upon detec- responded that they had difficulty bathing despite the watertion of an arrhythmia, the ECG is sent to a monitoring station resistant nature of the product (product is approved for use staffed with ECG-trained technicians. A diagnostic report with while showering). the resulting analysis is given to the patient’s physician at the The clarity and ease of understanding of the patient endend of the prescription period. The physician then notifies or of-use (EOU) report was also examined. The EOU report consults the patient and delivers the report to the patient. consists of the average heart rate histogram, sample ECGs of Some of the interview questions were open-ended (free each recorded event and the diagnosis for each epoch as answer), while others were multiple-choice-based on a Likert noted by the qualified technician. Final analysis, rhythm deciscale. The questions probed the patient’s comfort with the sion changes (if any) and recommended treatments are left patch, any obstacles faced, ease of understanding the diagnostic for the prescribing doctor. The results of the readability and report, motivation for treatment and value of the ELR. ease-of-understanding assessments are shown in FIGURE 4. Fifty five percent of respondents noted that it was easy or very easy Results to read and understand. A typical report had Flesch–Kincaid Patients were asked to assess their comfort level during appli- grade level of 11.1 and a Flesch–Kincaid reading ease score cation of the ELR and during the monitoring period. The of 42.2. results are shown in FIGURE 2. Five percent of patients found Patients were very motivated to find a diagnosis for the ELR very uncomfortable or uncomfortable, 2% were neu- their ailment. After the ELR was deployed and the EOU tral, 8% found it comfortable and 85% found the ELR very report was delivered via their physician, 43 patients (60% of B
100 90 80 70 Patients (n)
Downloaded by [University of Florida] at 12:58 10 November 2015
A
60 50 40 30 20 10 0
Fitting (n = 96) Monitoring (n = 86)
Very Uncomfortable uncomfortable 0 6
0 3
Neutral
Comfortable
Very comfortable
1 3
4 10
91 64
Figure 2. Distribution of patients’ experience with fitting and monitoring using the external loop recorder.
260
Expert Rev. Med. Devices 11(3), (2014)
Patient responses
Patient experience with a novel patch-like external loop recorder
Others
Special Report
1
Taking a bath
3
Skin irritation
16 74
No obstacles 0
10
20
30 40 50 Number of responses
60
70
80
72 respondents) mentioned that they were inclined or highly inclined to seek treatment. Sixty percent of patients (n = 82) also noted that they found good value in the ELR. The ELR also recorded high-fidelity ECGs with good detail (sampling frequency is 200 Hz with 10-bit resolution). An example of the ECG is shown in FIGURE 5. The report includes a daily average heart rate graph, a summary of each recorded episode with trigger type (auto or manual) and 6-s epochs of each recorded event. Expert commentary
of the device and the ability to shower were lauded by both patients and doctors as the major reasons for the high compliance during the monitoring period. This experience was pervasive among gender and various body weights (obese and thin patients alike). Furthermore, the automatic transmissions of arrhythmic events captured by the patch circumvented any need for the patient to manually transmit events to the staffed monitoring center. An important factor contributing to this comfort and snug adhesion of the patch is the cleanliness of the skin and removal of excess body hair from the site. Deviation from the instructions for use of the device can adversely affect patient comfort and device performance. Female patients particularly appreciated the small form factor which allowed for inconspicuous placement under clothing, as shown in FIGURE 6. The ELR can be completely hidden under loose Indian clothing such as a salwar or sari. Patient convenience also contributed to high-performance attributes. The auto-triggering mechanism of the ELR avoided complicated procedures for patient activation. Furthermore, when a patient is symptomatic, he/she may be preoccupied with the management of the acute situation, or may be unable to activate the device due to incapacitation (i.e., during syncope). One point of inconvenience may be the misplacement of the magnet necessary for patient triggering. The latest generation of the Nuvant device eliminates the need for a magnet.
This study examined the patient experience with the NuvantÒ Mobile Cardiac Telemetry System, with a broad lens of attributes that contribute to patient satisfaction. A negative experience with a treatment regimen can adversely affect patient compliance and render an otherwise effective strategy to an act of futility. The consequence of non-adherence, whether it is not following a doctor’s advice, disregarding a treatment regimen or not following a diagnostic procedure can be devastating. In the US, non-adherence can cost billions [7]. The indirect costs of non-compliance include poor health outcomes and in extreme cases death [8]. In the case of ambulatory cardiac diagnostics, the price of non-compliance could mean missing a dangerous arrhythmia. The cardiac diagnostic tool represented in this article represents the first step toward an efficacious therapy. Consistent with a previous study in which patient compliance was 98% [3], the results of 25 the patient experience were also promis33% ing. One study with a different mobile 20 24% cardiac outpatient telemetry device dem22% 15 onstrated a 53% general patient compli16% ance score and only 42% compliance 10 with scheduled (patient initiated) rhythm 5% 5 transmission [9]. In that study, typical reasons for failure to comply included rash 0 Very difficult Difficult Neutral Easy Very easy produced at the site of the electrode. 14 21 #Responses 15 10 3 Other general complaints can include discomfort due to wires or large form factor Patient responses device or inability to shower with the Figure 4. Patient reaction to the readability and ease of understanding of the device. In the current study with the end-of-use report (n = 63). Nuvant device, the small, wireless nature Patients (n)
Downloaded by [University of Florida] at 12:58 10 November 2015
Figure 3. Obstacles faced during the external loop recorder monitoring period (n = 94).
informahealthcare.com
261
Figure 5. Example end-of-use report.
Downloaded by [University of Florida] at 12:58 10 November 2015
Special Report
262 Shrivastav, Padte & Sinha
Expert Rev. Med. Devices 11(3), (2014)
Patient experience with a novel patch-like external loop recorder
Collarbone
Special Report
Collarbone Collarbone
Sternum
Sternum
Sternum
Male
Female
Female (petite)
Downloaded by [University of Florida] at 12:58 10 November 2015
Figure 6. The external loop recorder is placed inconspicuously on the chest using its self-adhesive backing.
Various other metrics denoted a positive patient experience. The outcome of 60% of patients being motivated to seek a treatment after the use of the ELR, and 60% of patients finding value in the device, further indicates a positive experience. Reading ease of the EOU report was mixed, with 55% easy/very easy and 40% difficult/very difficult. This result is not surprising since the EOU contains technical information. The Flesch–Kincaid score indicates that the text should be understandable by an 11th grade student. The difficulty in technical interpretation of reports was mitigated by the doctor’s consultation appointment in which the results of the monitoring report were explained to the patient. Good patient–doctor communication about the ambulatory monitoring device contributed to a positive patient experience. This result corroborates well with a separate study with an ambulatory blood pressure monitoring device in which the physician’s effectiveness in explaining the need and results of the ambulatory monitoring was linked to the patient’s perception of the diagnostic exam [10]. The same is true of the current study. Patients generally believed that the results are helpful in making treatment decisions. Finally, an in-country, local language-speaking customer service center also proactively helped patients with prescriptions which also increased patient satisfaction. In the rare case that the patient needs assistance during the monitoring period, the local customer service center called the patients or vice versa. Results from other studies have corroborated that clinically focused customer service initiatives in healthcare can substantially improve patients’ perception of quality and outcome [11]. Conclusion
For many patients with infrequent arrhythmias, the lack of a diagnosis can be a frustrating issue, as shown by the high patient motivation metrics in this study. Though satisfaction and comfort with the ELR improved compliance, overall patient satisfaction is a combination of clear and effective communication between the patient and physician in the context of the local culture, understanding of the diagnostic regimen and a common understanding of the goals. Patient
informahealthcare.com
satisfaction can have a dramatic effect on compliance and can impact the care pathway and diagnostic yield. Successful diagnostic strategies early in the pathway can lead to greater patient benefits. Long-term follow-up of patients who have undergone ambulatory monitoring, for example, has shown a reduction in syncopal events (when appropriate therapy is pursued) and a general improvement in quality of life [12]. In the final analysis, the ELR represents a cost-effective, high-yielding methodology for properly selected patients who suffer from arrhythmias [13]. Five-year review
Advances in medical devices are resulting in devices that are smaller, lighter and easier to use. Specifically for external cardiac diagnostic devices, the last decade has seen an evolution from bulky, wired, patient-triggered event recorders with nonlooping memory to compact mobile cardiac telemetry and ELRs that are simple and easy to use. From a patient perspective, advances in physical and electronic features that further minimize the impact to daily activities are likely. These include improvements in ease of use through simpler user interfaces that may interface with a smartphone. Such technology is already being explored for atrial fibrillation screening [14]. Further advancements in diagnostic sophistication are also likely to improve the physician’s ability to diagnose an arrhythmia. These may include enhanced artifact reduction, larger memory capacity and physical attributes to lengthen the monitoring period while maintaining patient comfort. Furthermore, concomitant with technological advances would be patient-centric educational materials. With medical devices such as the ELR described herein proliferating previously underserved healthcare markets like India, educational and awareness materials in multiple languages and media would need to be developed. Acknowledgements
The authors thank Paul Ziegler for assistance in the review of this manuscript. Authors acknowledge the assistance of Chidambar Joshi, Murali Srivathsa, John Russell, Saurin Shah, and the HHFA and sales team in contributing to a positive patient experience.
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Special Report
Shrivastav, Padte & Sinha
Financial & competing interests disclosure
M Shrivastav and S Padte are employees of Medtronic Inc. N Sinha is a prescriber of the ELR described herein. The authors have no other relevant affiliations or financial involvement with any organization or entity with
a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.
Key issues • This study assesses the patient experience from a 125-patient pilot study using a novel 7-day external loop recorder for cardiac arrhythmia detection in India. • A positive experience can have a dramatic impact on patient compliance, diagnostic yield and the appropriate care pathway. • 85% of patients found the external loop recorder very comfortable to wear and deploy. This was mainly attributable to the small form factor, ability to shower with the device and its wireless nature.
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