1
448 Electronic Patient Data Acquisition Tablet (ePDAT) Provides Customized, Flexible Scheduling For Collecting Patient Reported Outcomes (ePRO) With High Usability and Compliance Ideal For Use In Single and Multicenter Environmental Exposure Chamber Studies Mr. Dan Wilson, Dr. Piyush Patel, MD, FRCP, Konrad Boczula, Dr. AnneMarie Salapatek, PhD; Inflamax Research, Mississauga, ON, Canada. RATIONALE: The collection of ePRO in EEC studies requires the ability to collect pre-defined data points from multiple patients based upon their own unique start time of allergen exposure. Currently there are no validated ePRO tools available that allow the flexibility to document the moment of allergen exposure so that all data points are re-calculated on-demand. METHODS: Developed and validated 21CFR, Part 11 compliant system that allows users to create customized, prescheduled, protocol-specific ePRO events that are directly linked to the time-difference from a pre- defined reference point. RESULTS: Data from a recently completed clinical trial which collected 11,720 data points was examined. It was demonstrated that ePDAT system had the flexibility to pre-schedule patients preferred date and time of exposure in the EEC such that if the actual time of exposure differs, the ePRO system automatically re-calculated the exact time for all ePRO events. Once the actual time of exposure for any patient was entered into the system, the system automatically updated that patient’s ePRO schedule to all users, including those who are monitoring ePRO data collection within seconds. 100% data was captured with greater than 95% of all data points occurring as originally scheduled. CONCLUSIONS: Clinical trials conducted in the EEC are traditionally performed with large cohorts of patients studied simultaneously to reduce variability across patient allergen exposures and to promote clinical trial time and cost efficiencies. These data show that ePDAT can be implemented such that staff can easily manage changing schedules in both single and multicenter EEC and EEC/field hybrid studies. 449 Feasibility and Acceptability Of a Novel Asthma Self- Management Smartphone Application For Children and Adolescents Nabeel Farooqui, MD 1,2 , Gary Phillips, MAS 2 , David R. Stukus, MD, FAAAAI 1,2 ; 1 Nationwide Children’s Hospital, Columbus, OH, 2 Wexner Medical Center at The Ohio State University, Columbus, OH. RATIONALE: Asthma self-management skills are an important compo- nent in achieving optimal asthma control. However, previous data evaluating adherence to these strategies remains discouraging. In recent years, mobile device adoption has rapidly increased amongst children and teenagers, which coincides with an exponential growth in availability of mobile health applications. We aimed to leverage this use of technology and create an evidence-based smartphone application that improves asthma self-management. METHODS: A personalized, interactive iOS smartphone application (AsthmaCare) was created using Xcode (Apple Inc. Cupertino CA) and distributed to participants on iPod Touch devices. We conducted a prospec- tive, 30-day pilot study of patients with asthma, ages 9-16 years old, who had been prescribed at least one controller medication. Questionnaires were utilized to assess feasibility and acceptability of AsthmaCare. RESULTS: 21 patients completed the 30-day pilot study. 85% of patients interacted with the application at least on a daily basis, including tracking controller medication use and symptom occurrence. All participants reported comfort in using the app to help instruct them on treatment recommendations in case of worsening symptoms. Almost all(95%) preferred using the app to previously received methods of asthma counseling. All participants reported they would recommend the app to others with asthma. CONCLUSIONS: Adoption rate of our smartphone application amongst the pediatric population was high. This media not only provides a personalized approach to disease management, but also in an interactive format to which children and teenagers can relate to. Ongoing development of mobile applications offers a promising tool in the promotion of asthma management and medication adherence. 450 Experience In The Development Of a Mobile Diagnosis Support System For Asthma: Intelimed Prof. Silvia Wanick Sarinho, Sr, 1 Prof. J ulio Ven^ ancio Menezes J unior 1 , Prof. Cristine Gusm~ ao 1 , Nilza R. S. Lyra, MD 2 ; 1 Universidade Federal de Pernambuco, 2 Universidade Federal de Pernambuco, Recife PE, Brazil. RATIONALE: A clinical decision support system in the Estrategia Saude da Familia (Family Health Strategy) through the making of a ‘‘smart’’ decision tree in mobile devices by the engineering, computer sciences. METHODS: An ISAAC (International Study of Asthma and Allergies in Childhood), GINA (Global Initiative of Asthma) and Brazilian Consensus-based questionnaire was created, containing the mains attri- butes of asthma, having gone through face and content validation. A trans- versal study was conducted by apllying 113 questionnaires to guardians of children and teenagers (ranging from 5 to 19 years old) with medical ap- pointments in the Allergy and Immunology Clinic of the Hospital das Cl ınicas of Universidade Federal de Pernambuco (HC-UFPE) and in pri- vate practice.The app was tested by using 50 scenarios – 25 asthmatics and 25 non-asmathic patients. The evaluated Standards were accuracy, sensitivity and specificity (validation thourg the Leave-one-out method). RESULTS: Of The 113 Applied Questionnaires, There Were 72 Asthmatic Patients (Cases) And 41 Non-Asthmatics (Control). The Use Of The Prototype App And Decision Tree Has Presented The Following Results accuracy 76%; sensitivity 72%; specificity 82%. CONCLUSIONS: The asthma attributes relayed through mobile device can consist in an excellent tool to primary doctors, enabling access to the current medical consensus, with potential improved results in treatment. 451 An Assessment Of Food Allergy Knowledge Among Parents Of Children With Food Allergy and The Role Of An Educational Website Jamee Castillo, MD 1 , Neha Mehrotra, MD 1 , Raoul L. Wolf, MD, FAAAAI 2 , Ves Dimov, MD 3 ; 1 Internal Medicine Residency Program, Department of Medicine, University of Chicago, Chicago, IL, 2 Section of Allergy, Asthma and Immunology, Department of Pediatrics, Depart- ment of Medicine, University of Chicago, Chicago, IL, 3 University of Chi- cago Medicine, Chicago, IL. RATIONALE: This study investigates parents’ knowledge of food allergy management in their children and if use of an educational website increases knowledge. The Allergy and Immunology (AI) Clinic at University of Chicago provides a free educational website, AllergyGoAway.com, which aims to educate patients how to prevent, identify, and manage food allergic reactions and anaphylaxis. METHODS: Parents of patients with food allergy completed surveys during a follow-up visit at AI Clinic. The survey inquired about confidence and knowledge of food allergy topics and use of the website. Confidence was measured using a 5-point Likert scale. Knowledge was assessed using questions pooled from a validated knowledge quiz out of 8 points. RESULTS: 68 subjects were surveyed and majority (>87%) were knowledgeable in avoidance and recognizing symptom severity. Knowledge was poor (< 56%) regarding timing and management of anaphylaxis. Subjects were confident identifying and preventing symp- toms of food allergy and using epinephrine autoinjectors. They were not confident identifying signs of anaphylaxis and following a food allergy action plan. Only 7 subjects (10%) used the website, with no difference in knowledge between users and nonusers. CONCLUSIONS: Education during the patient encounter remains the standard to improve patient knowledge and should focus on specific warning signs of anaphylaxis, the importance of early intervention with epinephrine autoinjectors, and an allergy action plan to prevent fatality. Website use among the surveyed group was low. An online resource may not be sufficient to replace the education provided by healthcare workers during clinic visits. J ALLERGY CLIN IMMUNOL VOLUME 133, NUMBER 2 Abstracts AB127 SUNDAY

Electronic Patient Data Acquisition Tablet (ePDAT) Provides Customized, Flexible Scheduling For Collecting Patient Reported Outcomes (ePRO) With High Usability and Compliance Ideal

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Page 1: Electronic Patient Data Acquisition Tablet (ePDAT) Provides Customized, Flexible Scheduling For Collecting Patient Reported Outcomes (ePRO) With High Usability and Compliance Ideal

J ALLERGY CLIN IMMUNOL

VOLUME 133, NUMBER 2

Abstracts AB127

SUNDAY

448 Electronic Patient Data Acquisition Tablet (ePDAT) ProvidesCustomized, Flexible Scheduling For Collecting PatientReported Outcomes (ePRO) With High Usability andCompliance Ideal For Use In Single and MulticenterEnvironmental Exposure Chamber Studies

Mr. Dan Wilson, Dr. Piyush Patel, MD, FRCP, Konrad Boczula,

Dr. AnneMarie Salapatek, PhD; Inflamax Research, Mississauga, ON,

Canada.

RATIONALE: The collection of ePRO in EEC studies requires the ability

to collect pre-defined data points from multiple patients based upon their

own unique start time of allergen exposure. Currently there are no validated

ePRO tools available that allow the flexibility to document the moment of

allergen exposure so that all data points are re-calculated on-demand.

METHODS: Developed and validated 21CFR, Part 11 compliant system

that allows users to create customized, prescheduled, protocol-specific

ePRO events that are directly linked to the time-difference from a pre-

defined reference point.

RESULTS: Data from a recently completed clinical trial which collected

11,720 data points was examined. It was demonstrated that ePDAT system

had the flexibility to pre-schedule patients preferred date and time of

exposure in the EEC such that if the actual time of exposure differs, the

ePRO system automatically re-calculated the exact time for all ePRO

events. Once the actual time of exposure for any patient was entered into

the system, the system automatically updated that patient’s ePRO schedule

to all users, including those who are monitoring ePRO data collection

within seconds. 100% data was captured with greater than 95% of all data

points occurring as originally scheduled.

CONCLUSIONS: Clinical trials conducted in the EEC are traditionally

performed with large cohorts of patients studied simultaneously to reduce

variability across patient allergen exposures and to promote clinical trial

time and cost efficiencies. These data show that ePDAT can be

implemented such that staff can easily manage changing schedules in

both single and multicenter EEC and EEC/field hybrid studies.

449 Feasibility and Acceptability Of a Novel Asthma Self-Management Smartphone Application For Children andAdolescents

Nabeel Farooqui, MD1,2, Gary Phillips, MAS2, David R. Stukus, MD,

FAAAAI1,2; 1Nationwide Children’s Hospital, Columbus, OH, 2Wexner

Medical Center at The Ohio State University, Columbus, OH.

RATIONALE: Asthma self-management skills are an important compo-

nent in achieving optimal asthma control. However, previous data

evaluating adherence to these strategies remains discouraging. In recent

years, mobile device adoption has rapidly increased amongst children and

teenagers, which coincides with an exponential growth in availability of

mobile health applications. We aimed to leverage this use of technology

and create an evidence-based smartphone application that improves

asthma self-management.

METHODS: A personalized, interactive iOS smartphone application

(AsthmaCare) was created using Xcode (Apple Inc. Cupertino CA) and

distributed to participants on iPod Touch devices. We conducted a prospec-

tive, 30-day pilot study of patientswith asthma, ages 9-16 years old, who had

been prescribed at least one controller medication. Questionnaires were

utilized to assess feasibility and acceptability of AsthmaCare.

RESULTS: 21 patients completed the 30-day pilot study. 85% of patients

interacted with the application at least on a daily basis, including tracking

controller medication use and symptom occurrence. All participants

reported comfort in using the app to help instruct them on treatment

recommendations in case of worsening symptoms. Almost all(95%)

preferred using the app to previously received methods of asthma

counseling. All participants reported they would recommend the app to

others with asthma.

CONCLUSIONS: Adoption rate of our smartphone application amongst

the pediatric population was high. This media not only provides a

personalized approach to disease management, but also in an interactive

format towhich children and teenagers can relate to. Ongoing development

of mobile applications offers a promising tool in the promotion of asthma

management and medication adherence.

450 Experience In The Development Of a Mobile DiagnosisSupport System For Asthma: Intelimed

Prof. Silvia Wanick Sarinho, Sr,1 Prof. J�ulio Venancio Menezes J�unior1,

Prof. Cristine Gusm~ao1, Nilza R. S. Lyra, MD2; 1Universidade Federal de

Pernambuco, 2Universidade Federal de Pernambuco, Recife PE, Brazil.

RATIONALE: A clinical decision support system in the Estrategia Saude

da Familia (Family Health Strategy) through the making of a ‘‘smart’’

decision tree in mobile devices by the engineering, computer sciences.

METHODS: An ISAAC (International Study of Asthma and Allergies inChildhood), GINA (Global Initiative of Asthma) and Brazilian

Consensus-based questionnaire was created, containing the mains attri-

butes of asthma, having gone through face and content validation. A trans-

versal study was conducted by apllying 113 questionnaires to guardians of

children and teenagers (ranging from 5 to 19 years old) with medical ap-

pointments in the Allergy and Immunology Clinic of the Hospital das

Cl�ınicas of Universidade Federal de Pernambuco (HC-UFPE) and in pri-

vate practice.The app was tested by using 50 scenarios – 25 asthmatics

and 25 non-asmathic patients. The evaluated Standards were accuracy,

sensitivity and specificity (validation thourg the Leave-one-out method).

RESULTS: Of The 113 Applied Questionnaires, There Were 72 Asthmatic

Patients (Cases) And 41 Non-Asthmatics (Control). The Use Of The

Prototype App And Decision Tree Has Presented The Following Results

accuracy 76%; sensitivity 72%; specificity 82%.

CONCLUSIONS: The asthma attributes relayed through mobile device

can consist in an excellent tool to primary doctors, enabling access to the

current medical consensus, with potential improved results in treatment.

451 An Assessment Of Food Allergy Knowledge Among Parents OfChildren With Food Allergy and The Role Of An EducationalWebsite

Jamee Castillo, MD1, Neha Mehrotra, MD1, Raoul L. Wolf, MD,

FAAAAI2, Ves Dimov, MD3; 1Internal Medicine Residency Program,

Department of Medicine, University of Chicago, Chicago, IL, 2Section

of Allergy, Asthma and Immunology, Department of Pediatrics, Depart-

ment of Medicine, University of Chicago, Chicago, IL, 3University of Chi-

cago Medicine, Chicago, IL.

RATIONALE: This study investigates parents’ knowledge of food allergy

management in their children and if use of an educational website increases

knowledge. The Allergy and Immunology (AI) Clinic at University of

Chicago provides a free educational website, AllergyGoAway.com, which

aims to educate patients how to prevent, identify, and manage food allergic

reactions and anaphylaxis.

METHODS: Parents of patients with food allergy completed surveys

during a follow-up visit at AI Clinic. The survey inquired about confidence

and knowledge of food allergy topics and use of the website. Confidence

was measured using a 5-point Likert scale. Knowledge was assessed using

questions pooled from a validated knowledge quiz out of 8 points.

RESULTS: 68 subjects were surveyed and majority (>87%) were

knowledgeable in avoidance and recognizing symptom severity.

Knowledge was poor (< 56%) regarding timing and management of

anaphylaxis. Subjects were confident identifying and preventing symp-

toms of food allergy and using epinephrine autoinjectors. They were not

confident identifying signs of anaphylaxis and following a food allergy

action plan. Only 7 subjects (10%) used the website, with no difference in

knowledge between users and nonusers.

CONCLUSIONS: Education during the patient encounter remains the

standard to improve patient knowledge and should focus on specific

warning signs of anaphylaxis, the importance of early intervention with

epinephrine autoinjectors, and an allergy action plan to prevent fatality.

Website use among the surveyed group was low. An online resource may

not be sufficient to replace the education provided by healthcare workers

during clinic visits.