Wireless Transmission Of Spirometric… By Stephen A. Raymond, Ph D

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Wireless Transmission of Spirometric Measurements to ePRO Devices Used by Subjects with Asthma

by Stephen A. Raymond, PhD
Chief Scientific Officer and Founder
PHT Corporation

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  • Wireless Transmission Of Spirometric… By Stephen A. Raymond, Ph D

    1. 1. Wireless Transmission of Spirometric Measurements to ePRO Devices Used by Subjects with Asthma Stephen A. Raymond, PhD Chief Scientific Officer and Founder PHT Corporation
    2. 2. Relation to Session Objective <ul><li>“… Tools that can enhance the quality and reliability of data” </li></ul><ul><li>Companies sponsoring clinical trials that rely on patient self-reported data for primary or secondary endpoints must be confident that such data are correct and trustworthy. </li></ul><ul><li>Examples of self-reported data include symptom scores (e.g. peak expiratory flow, pain, nausea, sleep quality), patient behavior (e.g. medication consumption, vomiting, sleep time) and physiological measures from devices (e.g. physical activity, bodyweight). </li></ul><ul><li>Research using paper methods to capture self-reported data from measuring devices has shown that subjects invent data, enter erroneous data, enter data that is illegible, incomplete or in an incorrect format, or, worse, provide no data at all (Ref 1-4). </li></ul>
    3. 3. Spirometric Data Quality <ul><li>Data Quality problems—An Example </li></ul><ul><li>Childhood asthma study done by G. Jonasson et. al. (Ref 3) </li></ul><ul><li>Subjects reported consuming medication from a metered dose inhaler. </li></ul><ul><ul><li>200 doses </li></ul></ul><ul><ul><li>Instrumented to track actual consumption and compliance with the dosing schedule. </li></ul></ul><ul><li>All subjects reported high med compliance on paper diaries, </li></ul><ul><li>the measured compliance from the inhaler [200–No. of remaining doses)/No. of prescribed doses] was: </li></ul><ul><ul><li>Lower than reported , indicating that subjects faked data. </li></ul></ul><ul><ul><li>Most subjects faked data </li></ul></ul><ul><ul><li>some subjects invented almost all the data. </li></ul></ul><ul><li>Even those subjects with the worst measured compliance entered readings on their paper diaries for nearly all of the expected doses. </li></ul>
    4. 4. Rationale for Wireless System <ul><li>Self-reported peak flow data are known to be inaccurate when entered in paper diaries </li></ul><ul><li>Regulatory agencies recommend “electronic diaries” (Ref 5-6) “to validate the timing” of transcribed measurements and to ensure compliance calculations are “reliable” </li></ul><ul><li>but any method that relies on the subjects to read and transcribe values also remains vulnerable to transcription errors and invented data. </li></ul>
    5. 5. eDiary and Wireless PEF Option1. Wireless (short-range ~10 feet) radio link) Option 2. Manual Transcription PEF, FEV1 from Meter to eDiary
    6. 6. Field Experience in Trials <ul><li>Methods: </li></ul><ul><li>Subjects were provided with an electronic patient diary (eDiary), and a PEF meter </li></ul><ul><li>equipped with wireless technology that automatically sends data to the eDiary. </li></ul><ul><li>Subjects were also given the option to transcribe PEF readings manually into the eDiary, without the use of the wireless transfer feature. </li></ul>
    7. 7. Field Experience in Trials <ul><li>Methods, example 1: </li></ul><ul><li>172 Subjects were provided with an electronic patient diary (eDiary), and a PEF meter </li></ul><ul><li>Wireless, automatic transfer of data to the eDiary was enabled for each subject. </li></ul><ul><li>Subjects were also given the option to transcribe PEF readings manually into the eDiary, without the use of the wireless transfer feature. </li></ul>
    8. 8. Example 1: results <ul><li>12,195 individual PEF score measurements </li></ul><ul><li>23 European Investigative Sites </li></ul>
    9. 9. Example 1: the “manual” choice
    10. 10. Example 1: Sites matter
    11. 11. Data Quality--Completions <ul><li>Expectation: During participation (Assignment of the eDiary until the last eDiary report transmitted) </li></ul><ul><ul><li>morning and evening diary were expected each day </li></ul></ul><ul><li>Completions: Most subjects conformed. Median percent completion compliance: </li></ul><ul><ul><li>For the morning diary was 97.96% </li></ul></ul><ul><ul><li>For the evening diary 99.07%. </li></ul></ul><ul><li>subjects in the range of 95-100%: </li></ul><ul><ul><li>123 for the morning diary </li></ul></ul><ul><ul><li>114 for the evening diary </li></ul></ul><ul><ul><li>Only four subjects had completion compliances for either diary at 70% or less. </li></ul></ul>
    12. 12. Conclusions-Example 1 <ul><li>A portable electronic monitoring system to prevent false self-reported PEF data by using wireless uploads to an eDiary was feasible for a multicenter, multinational clinical investigation. </li></ul><ul><li>More than 85% of the PEF data automatically </li></ul><ul><ul><li>where the PEF value, time of capture could NOT be invented, manually altered, or erroneously transcribed. </li></ul></ul><ul><li>Subjects completed almost every report that was expected even though no report could be entered retrospectively. </li></ul><ul><ul><li>Reports could be completed only during 6 hour windows in the morning and evening. </li></ul></ul><ul><ul><li>Constraining the availability of eDiary reports for completion did not unduly reduce the number of reports that subjects completed. </li></ul></ul><ul><li>Choice of manual vs automatic transfer of PEF data depended on site. </li></ul>
    13. 13. Completions: Field Experience AVERAGE Completion Compliance for 3,365 Subjects *Trials still recruiting the number of subjects enrolled are shown relative to the number of planned randomized subjects . 94% 718 673 Yes 20 of 558 23 of 33 COPD 10* 74% 1,508 1,118 No 56 of 336 62 of 83 COPD 9* 96% 5,572 5,332 Yes 33 0f 45 96 of 320 Asthma 8* 89% 35,602 31,658 Yes 67 450 COPD 7 95% 127,261 120,818 Yes 76 660 COPD 6 95% 8,892 8,460 Yes 8 100 COPD 5 97% 8,266 7,996 No 22 100 Asthma 4 97% 39,932 38,416 No 72 600 Asthma 3 95% 12,826 12,195 Yes 18 172 Asthma 2 79% 398,296 316,420 No 147 1102 Asthma 1 Completion Compliance Expected Daily Diaries Received Daily Diaries eSense PiKo Sites Subjects Indication
    14. 14. Conclusions-Data Quality <ul><li>Wireless Spirometric Devices </li></ul><ul><ul><li>Yield data of validated quality </li></ul></ul><ul><ul><li>Prevent many known data quality problems </li></ul></ul><ul><ul><li>Are feasible for subjects to use </li></ul></ul><ul><ul><li>Add objective information to eDiary data </li></ul></ul><ul><ul><li>Do not diminish the completion compliance for ePRO data </li></ul></ul>
    15. 15. References <ul><li>1. Verschelden P., A. Cartier, J. L’Archevêque, C. Trudeau, J. L. Malo. Compliance with and accuracy of daily self-assessment of peak expiratory flows (PEF) in asthmatic subjects over a three month period. 1996. Eur Respir J. May;9(5):880-5. </li></ul><ul><li>2. Milgrom H., B. Bender, L. Ackerson, P. Bowry, B. Smith, C. Rand. Noncompliance and treatment failure in children with asthma. 1996. J Allergy Clin Immunol. Dec;98(6 Pt 1):1051-7. </li></ul><ul><li>3. Jónasson G., K. H. Carlsen, A. Sødal, C. Jonasson, P. Mowinckel. Patient compliance in a clinical trial with inhaled budesonide in children with mild asthma. 1999. Eur Respir J. Jul;14(1):150-4. </li></ul><ul><li>4. Kamps A.W., R. J. Roorda, P. L. Brand. Peak flow diaries in childhood asthma are unreliable. 2001. Thorax. Mar;56(3):180-2. </li></ul><ul><li>5. Note for guidance on the clinical investigation of medicinal products in the treatment of asthma, EMEA CPMP/EWP/2922/01, 2002 </li></ul><ul><li>6. Guideline on clinical investigation of steroid contraceptives in women, EMEA CPMP/EWP/519/98 Rev 1, 2005 </li></ul><ul><li>7. Raymond SA, Blackadar T, Oueida W, Ohlenbusch NE. Preventing false spirometry values and invalid symptom scores in respiratory clinical trials. The Journal of Allergy and Clinical Immunology, Supplement Feb. 2004:113(2):S277 </li></ul>
    16. 16. Disclaimer <ul><li>The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. </li></ul><ul><li>  </li></ul><ul><li>These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. </li></ul>

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