A pdf is attached above in the link for the article. What do the researchers think this study contributes? What are its limitations? Not a writing assigment

Biomedical Instrumentation Systems
1st Edition
ISBN:9781133478294
Author:Chatterjee
Publisher:Chatterjee
Chapter21: Regulation And Standards
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A pdf is attached above in the link for the article. 

 

  • What do the researchers think this study contributes?
  • What are its limitations? 

Not a writing assigment 

 

YAO ET AL.
The patient site was implemented with two pos-
sible configurations, depending on the availability
of access point devices to the Internet. If a PC or
laptop is available, the audiometer can be con-
nected to the computer through an EZURIO (Laird
Technologies, St. Louis, MO) Bluetooth-USB adapt-
er¹3 and exchanges data with the application server
over the Internet. In cases where a computer is not
available at the test site, a wireless Bluetooth-IP
gateway device (Parani 1000, SENA Technologies,
San Jose, CA) ¹4 can be used to bridge the audiom-
eter and the Internet.
The clinical effectiveness of the prototype sys-
tem was primarily evaluated from two perspec-
tives: (1) the agreement of the hearing threshold
findings obtained from the teletests to those from
the conventional tests; and (2) the amount of time
ECU Allied
Health Building
Patient
780 TELEMEDICINE and e-HEALTH OCTOBER 2009
that is required to conduct hearing tests using the two testing modes.
In the current testing setup (Fig. 3), the subjects (audiometer via
access device) and the audiologists (using an Internet browsing
device) both access the Internet from a building on the medical
campus at East Carolina University and exchange data through the
application server located on the main campus. At the physical layer,
the two campuses are connected with 1 gigabit per second fiber
connections. Two Cisco (Cisco Systems, San Jose, CA) routers, one
on each campus, manage data traffic transmitted between the two
campuses. The audiometer used was an OTOPod from Otovation LLC
(King of Prussia, PA) with TDH-39 earphones.
15
With Institutional Review Board approval, 25 volunteers were
recruited to participate in the hearing tests. They had a mean age of 24
years, with a range of 20-60 years. All volunteers were college students
and faculty in the School of Allied Health Sciences at East Carolina
University. Medical and audiological histories were not known to the
examining audiologists. The threshold procedure administered fol-
lowed the American Speech-Hearing-Language Association (ASHA)
guidelines ¹5 for audiometric evaluation. Each subject received an
auditory threshold assessment with two different audiometric systems
under three different data exchange configurations. The subjects were
blinded as to which configuration was being used in the assessment
procedure. The 3 independent audiologists were also blinded as to the
results from other testing. Both the ear and the order of testing were
counterbalanced. Air conduction thresholds were assessed at octave
steps from 250 to 8,000 Hz. For all of the testing sessions, six pure
tone thresholds were obtained. For all tests, the subjects were seated
in a sound-treated room meeting the American National Standards
Audiologist
Fig. 3. Current configuration of the prototyped distributed system. ECU, East Carolina
University.
ECU
Intranet
Institute (ANSI) S3.1-1991 standards. 16 The audiometer used in the tests
was calibrated to ANSI S3.1-1996 standards. ¹7
Remote I
Results
The pure tone threshold findings obtained from the standard mode
and the remote mode with the two Internet access configurations are
summarized in Table 1. Although some differences exist among the
three testing modes, results are still comparable at all frequencies.
In order to further examine the interconnection among different
testing modes, the results were further analyzed using a two-factor
(testing conditions: standard, remote with gateway, and remote with
computer; and tone frequencies) repetitive (25 observations, 1 from
each subject) analysis of variance.
As expected, the results demonstrated no significant differences in
threshold findings between test approaches (df = 2, p = 0.6747 >> 0.05)
thresholds are significantly different at various frequencies (df = 5, p
Remote II
Table 1. Mean and Standard Deviation of Hearing Thresholds
by Stimulus Frequency and Assessment Method
FREQUENCY 250 500 1,000 2,000 4,000 8,000
Standard
3.23 2.94 1.47 3.82
5.8
7.12
3.99
3.61
2.35
5.89
2.5
5.47
SD, standard deviation.
2.64
5.03
ECU Science and
Technology Building
Server
3.12
5.12
0.88
3.63
2.5
6.05
5.31
8.26
7.35 11.17 Mean
10.99 16.77 SD
3.82
6.47
10.88
8.39 11.00 16.41
9.06 12.81
9.86 18.88
Mean
SD
Mean
SD
= 0). The analysis of the findings validated the feasibility of replacing
conventional "face-to-face" tests with the remote hearing tests using
the distributed system. Note that, since the 3 audiologists who partici-
pated in the project alternated the standard and the remote test modes,
these results should accommodate interexaminer variations.
Average completion time for testing sessions were also collected and
compared between the three testing approaches. As shown in Figure 4,
the average time for a standard test (3.72 minutes) is noticeably shorter
than that of a remote test (6.45 minutes and 5.72 minutes for the two
remote configurations with a wireless gateway device or computer used
as the Internet access point). Although the two remote modes take a lon-
ger time to complete a hearing test, collecting six pure tone thresholds in
less than 7 minutes is acceptable. This difference between standard tests
and those with remote modes was a result of a combination of factors:
Compared to the conventional mode, the audiologist needs to log
into the system and connect to the remote device through the
Internet before starting the hearing test.
• Data communication between the devices connected to the
Internet may make multiple attempts if a data packet cannot be
successfully transmitted to the intended destination.
A few other observations are worthy of mention: audiologists who
are familiar with conventional hearing assessment software can oper-
ate the user interface with minimal training. Survey results collected
after the test demonstrated a high level of satisfaction and interests in
adopting a similar system if commercial products are available.
●
Testing time (min)
8
0
Average testing time with the three conditions
I
Remote w/
gateway
Remote w/
computer
Testing conditions
Standard
Fig. 4. Testing time comparison: the remote testing approaches
versus standard testing approach.
WEB SERVICES-BASED TELE-AUDIOLOGY SYSTEM
Discussion
During tests with remote modes, although the patient and the audi-
ologist were connected through the Internet in terms of signal trans-
mission, they were actually situated in the same building. A great
deal of coordination ensured smooth testing, which is a reminder that
the coordination between the clinical professional site and a distant
patient site will be challenging. Patient sites must be integrated into
existing facilities where professional help is available, such as com-
munity health centers or remote telemedicine centers. In addition, an
online multimedia communication tool is crucial to make both sites
synchronized. Existing videoconference and text messaging software
should satisfy communication requirements and support interactions
using signing language or instant messages between the two parties.
The technologies utilized in this prototype can be extended to most
audiology practices. The utilization of common technologies allows all
these services to be integrated under the same umbrella and be imple-
mented on an application server hosted by a third party IT agent. The
introduction of this new model may result in the following benefits:
• The separation of clinical practice from technical support/ser-
vices removes the necessity of having technical personnel at
the clinical professional site, facilitating its widespread adoption
by hospitals and clinic service departments, especially private
practices.
MARY ANN LIEBERT, INC.
• The system can be expanded to include online scheduling,
accounting, and reimbursement. The management software can
be hosted by a third party agent, avoiding software installation
on the operator's computer.
• The audiometer's Bluetooth telemetry connection to the Internet
can take two configurations, using a regular computer or dedi-
cated access point device, providing the desired flexibility to the
patient site.
• The clinical professional site requires a regular Web page browser
without any additional software installation to conduct hearing
tests. In our tests, the system worked well with different versions
of Internet Explorer (IE7 and IE 8), Firefox, and Tencent Traveler
(TT) (Tencent Holdings, Ltd., China). Any Internet access devices,
such as PCs, laptops, personal digital assistants, or cell phones,
could possibly be used for this application, giving audiologists
great flexibility in terms of working environment.
The new system also brings the following considerations:
• Trained personnel must be present at the remote site.
• Licensure/regulatory laws in audiology vary between states as
well as countries; thus, this must be considered.
• Insurance reimbursement is not clearly defined and efforts need
to continue in this area.
●
VOL. 15 NO. 8 • OCTOBER 2009 TELEMEDICINE and e-HEALTH 781
Transcribed Image Text:YAO ET AL. The patient site was implemented with two pos- sible configurations, depending on the availability of access point devices to the Internet. If a PC or laptop is available, the audiometer can be con- nected to the computer through an EZURIO (Laird Technologies, St. Louis, MO) Bluetooth-USB adapt- er¹3 and exchanges data with the application server over the Internet. In cases where a computer is not available at the test site, a wireless Bluetooth-IP gateway device (Parani 1000, SENA Technologies, San Jose, CA) ¹4 can be used to bridge the audiom- eter and the Internet. The clinical effectiveness of the prototype sys- tem was primarily evaluated from two perspec- tives: (1) the agreement of the hearing threshold findings obtained from the teletests to those from the conventional tests; and (2) the amount of time ECU Allied Health Building Patient 780 TELEMEDICINE and e-HEALTH OCTOBER 2009 that is required to conduct hearing tests using the two testing modes. In the current testing setup (Fig. 3), the subjects (audiometer via access device) and the audiologists (using an Internet browsing device) both access the Internet from a building on the medical campus at East Carolina University and exchange data through the application server located on the main campus. At the physical layer, the two campuses are connected with 1 gigabit per second fiber connections. Two Cisco (Cisco Systems, San Jose, CA) routers, one on each campus, manage data traffic transmitted between the two campuses. The audiometer used was an OTOPod from Otovation LLC (King of Prussia, PA) with TDH-39 earphones. 15 With Institutional Review Board approval, 25 volunteers were recruited to participate in the hearing tests. They had a mean age of 24 years, with a range of 20-60 years. All volunteers were college students and faculty in the School of Allied Health Sciences at East Carolina University. Medical and audiological histories were not known to the examining audiologists. The threshold procedure administered fol- lowed the American Speech-Hearing-Language Association (ASHA) guidelines ¹5 for audiometric evaluation. Each subject received an auditory threshold assessment with two different audiometric systems under three different data exchange configurations. The subjects were blinded as to which configuration was being used in the assessment procedure. The 3 independent audiologists were also blinded as to the results from other testing. Both the ear and the order of testing were counterbalanced. Air conduction thresholds were assessed at octave steps from 250 to 8,000 Hz. For all of the testing sessions, six pure tone thresholds were obtained. For all tests, the subjects were seated in a sound-treated room meeting the American National Standards Audiologist Fig. 3. Current configuration of the prototyped distributed system. ECU, East Carolina University. ECU Intranet Institute (ANSI) S3.1-1991 standards. 16 The audiometer used in the tests was calibrated to ANSI S3.1-1996 standards. ¹7 Remote I Results The pure tone threshold findings obtained from the standard mode and the remote mode with the two Internet access configurations are summarized in Table 1. Although some differences exist among the three testing modes, results are still comparable at all frequencies. In order to further examine the interconnection among different testing modes, the results were further analyzed using a two-factor (testing conditions: standard, remote with gateway, and remote with computer; and tone frequencies) repetitive (25 observations, 1 from each subject) analysis of variance. As expected, the results demonstrated no significant differences in threshold findings between test approaches (df = 2, p = 0.6747 >> 0.05) thresholds are significantly different at various frequencies (df = 5, p Remote II Table 1. Mean and Standard Deviation of Hearing Thresholds by Stimulus Frequency and Assessment Method FREQUENCY 250 500 1,000 2,000 4,000 8,000 Standard 3.23 2.94 1.47 3.82 5.8 7.12 3.99 3.61 2.35 5.89 2.5 5.47 SD, standard deviation. 2.64 5.03 ECU Science and Technology Building Server 3.12 5.12 0.88 3.63 2.5 6.05 5.31 8.26 7.35 11.17 Mean 10.99 16.77 SD 3.82 6.47 10.88 8.39 11.00 16.41 9.06 12.81 9.86 18.88 Mean SD Mean SD = 0). The analysis of the findings validated the feasibility of replacing conventional "face-to-face" tests with the remote hearing tests using the distributed system. Note that, since the 3 audiologists who partici- pated in the project alternated the standard and the remote test modes, these results should accommodate interexaminer variations. Average completion time for testing sessions were also collected and compared between the three testing approaches. As shown in Figure 4, the average time for a standard test (3.72 minutes) is noticeably shorter than that of a remote test (6.45 minutes and 5.72 minutes for the two remote configurations with a wireless gateway device or computer used as the Internet access point). Although the two remote modes take a lon- ger time to complete a hearing test, collecting six pure tone thresholds in less than 7 minutes is acceptable. This difference between standard tests and those with remote modes was a result of a combination of factors: Compared to the conventional mode, the audiologist needs to log into the system and connect to the remote device through the Internet before starting the hearing test. • Data communication between the devices connected to the Internet may make multiple attempts if a data packet cannot be successfully transmitted to the intended destination. A few other observations are worthy of mention: audiologists who are familiar with conventional hearing assessment software can oper- ate the user interface with minimal training. Survey results collected after the test demonstrated a high level of satisfaction and interests in adopting a similar system if commercial products are available. ● Testing time (min) 8 0 Average testing time with the three conditions I Remote w/ gateway Remote w/ computer Testing conditions Standard Fig. 4. Testing time comparison: the remote testing approaches versus standard testing approach. WEB SERVICES-BASED TELE-AUDIOLOGY SYSTEM Discussion During tests with remote modes, although the patient and the audi- ologist were connected through the Internet in terms of signal trans- mission, they were actually situated in the same building. A great deal of coordination ensured smooth testing, which is a reminder that the coordination between the clinical professional site and a distant patient site will be challenging. Patient sites must be integrated into existing facilities where professional help is available, such as com- munity health centers or remote telemedicine centers. In addition, an online multimedia communication tool is crucial to make both sites synchronized. Existing videoconference and text messaging software should satisfy communication requirements and support interactions using signing language or instant messages between the two parties. The technologies utilized in this prototype can be extended to most audiology practices. The utilization of common technologies allows all these services to be integrated under the same umbrella and be imple- mented on an application server hosted by a third party IT agent. The introduction of this new model may result in the following benefits: • The separation of clinical practice from technical support/ser- vices removes the necessity of having technical personnel at the clinical professional site, facilitating its widespread adoption by hospitals and clinic service departments, especially private practices. MARY ANN LIEBERT, INC. • The system can be expanded to include online scheduling, accounting, and reimbursement. The management software can be hosted by a third party agent, avoiding software installation on the operator's computer. • The audiometer's Bluetooth telemetry connection to the Internet can take two configurations, using a regular computer or dedi- cated access point device, providing the desired flexibility to the patient site. • The clinical professional site requires a regular Web page browser without any additional software installation to conduct hearing tests. In our tests, the system worked well with different versions of Internet Explorer (IE7 and IE 8), Firefox, and Tencent Traveler (TT) (Tencent Holdings, Ltd., China). Any Internet access devices, such as PCs, laptops, personal digital assistants, or cell phones, could possibly be used for this application, giving audiologists great flexibility in terms of working environment. The new system also brings the following considerations: • Trained personnel must be present at the remote site. • Licensure/regulatory laws in audiology vary between states as well as countries; thus, this must be considered. • Insurance reimbursement is not clearly defined and efforts need to continue in this area. ● VOL. 15 NO. 8 • OCTOBER 2009 TELEMEDICINE and e-HEALTH 781
In the current study, volunteers were mostly students in East
Carolina University's Communication Sciences program. Although
some volunteers had certain hearing impairments, they were not
active clinical patients. To fully investigate the feasibility and pos-
sible issues of the system, we plan to extend our tests to clinical
environments and collect effectiveness data when the examiner and
participant are located in different geographic locations. Continued
efforts will also focus on using various Internet connections.
In conclusion, our new system presents a promising approach to
implement hearing healthcare to remote sites with little technology
requirements at the remote site. Other aspects of the system may
allow professionals to see more patients in a more efficient and less
costly manner.
Acknowledgment
The authors thank Ms. Ellen Crowell and Ms. Jessica Pierce, both
Ph.D. students in the Department of Communication Sciences and
Disorders, for their help in data collection. We also want to thank the
networking support staff in the College of Technology and Computer
Science for their support with setting up and maintaining the appli-
cation server.
Disclosure Statement
Authors Yao and Givens along with East Carolina University have
a provisional patent pending regarding the system used in this study.
No competing financial interests exist with author Wan.
REFERENCES
1. Lin JC. Current developments in telemedicine. IEEE Eng Med Biol Magazine
1999;18:22-27.
2. Givens GD, Elangovan S. Internet Application to Tele-Audiology-"Nothin'
but Net." Am J Audiol 2003;12:59-65.
3. Krumm M, Ribera J, Schmiedge J. Using a telehealth medium for objective
hearing testing: Implications for supporting rural universal newborn hearing
screening programs. Semin Hearing 2005;26:3-12.
4. Lancaster P, Krumm M, Ribera J, Klich R. Remote hearing screenings via
telehealth in a rural elementary school. Am J Audiol 2008;17:114-122.
5. Choi JM, Lee HB, Park CS, Oh SH, Park KS. PC-based tele-audiometry.
Telemed Je-Health 2007;13:501-508.
6. World Health Organization. Primary ear and hearing care training resource:
Advanced level. Geneva: World Health Organization, 2006.
7. Cruickshanks KJ, Wiley TL, Tweed TS, et al. Prevalence of hearing loss in older
adults in Beaver Dam, Wisconsin: the Epidemiology of Hearing Loss Study.
Am J Epidemiol 1998;148:879-886.
8. Agrawal Y, Platz E, Niparko JK. Prevalence of hearing loss and differences
by demographic characteristics among US adults, Data from the National
Health and Nutrition Examination Survey, 1999-2004. Arch Intern Med
2008;168:1522-1530.
9. US Department of Commerce. Statistical abstract of the United States.
117th ed. Washington, DC: US Census Bureau, 1997.
10. Gates GA, Cooper JC Jr, Kannel WB, Miller NJ. Hearing in the elderly:
The Framingham cohort, 1983-1985; part I: basic audiometric test results.
Ear Hear 1990;11:247-256.
11. Rueben D, Walsh K, Moore A, et al. Hearing loss in community-dwelling older
persons: National prevalence data and identification using simple questions.
J Am Geriatr Soc 1998;46:1008-1011.
12. Pioneers in Telemedicine Interview with COL Ron K. Poropatich, M.D.
Telemed e-Health 2008;14:413-417.
13. Laird Technologies, "Bluetooth High Speed USB Adapter." Available at: http://
www.ezurio.com/products/highspeedusbadaptor/ (Last accessed April 11, 2009).
14. SENA Technologies, Inc., "Bluetooth/IP Gateway for multi-port wireless connections,
Parani 1000." Available at: http://www.sena.com/download/datasheets/ds_parani_
msp1000.pdf (Last accessed April 11, 2009).
15. American Speech-Language-Hearing Association (ASHA). Guidelines for manual
pure-tone threshold audiometry. Rockville, MD, 2005.
16. American National Standards Institute. Maximum permissible ambient noise
levels for audiometric test rooms (ANSI S3-1-1991). New York: ANSI, 1991.
17. American National Standards Institute. Specifications for audiometers
(ANSI S3.6-1996). New York: ANSI, 1996.
Address correspondence to:
Jianchu Yao, Ph.D.
Department of Engineering
College of Technology and Computer Science
East Carolina University
Greenville, NC 27858
E-mail: Yaoj@ecu.edu
Received: March 14, 2009
Accepted: May 1, 2009
Transcribed Image Text:In the current study, volunteers were mostly students in East Carolina University's Communication Sciences program. Although some volunteers had certain hearing impairments, they were not active clinical patients. To fully investigate the feasibility and pos- sible issues of the system, we plan to extend our tests to clinical environments and collect effectiveness data when the examiner and participant are located in different geographic locations. Continued efforts will also focus on using various Internet connections. In conclusion, our new system presents a promising approach to implement hearing healthcare to remote sites with little technology requirements at the remote site. Other aspects of the system may allow professionals to see more patients in a more efficient and less costly manner. Acknowledgment The authors thank Ms. Ellen Crowell and Ms. Jessica Pierce, both Ph.D. students in the Department of Communication Sciences and Disorders, for their help in data collection. We also want to thank the networking support staff in the College of Technology and Computer Science for their support with setting up and maintaining the appli- cation server. Disclosure Statement Authors Yao and Givens along with East Carolina University have a provisional patent pending regarding the system used in this study. No competing financial interests exist with author Wan. REFERENCES 1. Lin JC. Current developments in telemedicine. IEEE Eng Med Biol Magazine 1999;18:22-27. 2. Givens GD, Elangovan S. Internet Application to Tele-Audiology-"Nothin' but Net." Am J Audiol 2003;12:59-65. 3. Krumm M, Ribera J, Schmiedge J. Using a telehealth medium for objective hearing testing: Implications for supporting rural universal newborn hearing screening programs. Semin Hearing 2005;26:3-12. 4. Lancaster P, Krumm M, Ribera J, Klich R. Remote hearing screenings via telehealth in a rural elementary school. Am J Audiol 2008;17:114-122. 5. Choi JM, Lee HB, Park CS, Oh SH, Park KS. PC-based tele-audiometry. Telemed Je-Health 2007;13:501-508. 6. World Health Organization. Primary ear and hearing care training resource: Advanced level. Geneva: World Health Organization, 2006. 7. Cruickshanks KJ, Wiley TL, Tweed TS, et al. Prevalence of hearing loss in older adults in Beaver Dam, Wisconsin: the Epidemiology of Hearing Loss Study. Am J Epidemiol 1998;148:879-886. 8. Agrawal Y, Platz E, Niparko JK. Prevalence of hearing loss and differences by demographic characteristics among US adults, Data from the National Health and Nutrition Examination Survey, 1999-2004. Arch Intern Med 2008;168:1522-1530. 9. US Department of Commerce. Statistical abstract of the United States. 117th ed. Washington, DC: US Census Bureau, 1997. 10. Gates GA, Cooper JC Jr, Kannel WB, Miller NJ. Hearing in the elderly: The Framingham cohort, 1983-1985; part I: basic audiometric test results. Ear Hear 1990;11:247-256. 11. Rueben D, Walsh K, Moore A, et al. Hearing loss in community-dwelling older persons: National prevalence data and identification using simple questions. J Am Geriatr Soc 1998;46:1008-1011. 12. Pioneers in Telemedicine Interview with COL Ron K. Poropatich, M.D. Telemed e-Health 2008;14:413-417. 13. Laird Technologies, "Bluetooth High Speed USB Adapter." Available at: http:// www.ezurio.com/products/highspeedusbadaptor/ (Last accessed April 11, 2009). 14. SENA Technologies, Inc., "Bluetooth/IP Gateway for multi-port wireless connections, Parani 1000." Available at: http://www.sena.com/download/datasheets/ds_parani_ msp1000.pdf (Last accessed April 11, 2009). 15. American Speech-Language-Hearing Association (ASHA). Guidelines for manual pure-tone threshold audiometry. Rockville, MD, 2005. 16. American National Standards Institute. Maximum permissible ambient noise levels for audiometric test rooms (ANSI S3-1-1991). New York: ANSI, 1991. 17. American National Standards Institute. Specifications for audiometers (ANSI S3.6-1996). New York: ANSI, 1996. Address correspondence to: Jianchu Yao, Ph.D. Department of Engineering College of Technology and Computer Science East Carolina University Greenville, NC 27858 E-mail: Yaoj@ecu.edu Received: March 14, 2009 Accepted: May 1, 2009
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