Eustachian Tube Dysfunction Patient Questionnaire (ETDQ-7) Collection, Training and Utility

Transcription

1 Eustachian Tube Dysfunction Patient Questionnaire (ETDQ-7) Collection, Training and Utility 2017 Acclarent, Inc. All rights reserved

2 ETDQ-7: What is it? The ETDQ-7 is a disease-specific instrument for the assessment of patientreported severity of ETD. Scores are reported on a scale from 1-7. The higher score indicates more severe symptoms. The total score is divided by the number of items (7) to give an overall score ranging from 1-7. The difference between preoperative and postoperative scores yields a change score that is used to report outcomes. Before the ETDQ-7, the SNOT-22 was used as a comparison measure because of the observed comorbidity of sinonasal disease with ETD¹ ¹ McCoul, E.D. & Anand, V.K. (2012). Eustachian tube balloon dilation surgery. International Forum of Allergy & Rhinology, vol 2,

3 ETDQ-7 Utility: Why Collect this Information? GOAL: Track and measure patient symptoms and QOL 1. Electronic Health Records Tracking Patient Outcomes Accountable Care Organizations Reimbursement Patient Assessment: Medical History, CT Scans, ETDQ-7 Patient Symptom Scores 2. Confirmation of Procedure Success 3. Share your patient outcomes with Referring Physicians and Patients Peer to Peer Education Patient Referral Marketing Patient Testimonials 4. Patient Identification 3

4 ETDQ-7 Collection Process 1. Give to all ETD patients 2. Make copy for patients records 3. Give the patient an ETDQ-7 form at 4 week/initial follow-up² 4. Make copy for patients records 5. The office inputs info into the tracker 6. Results can be posted in P2P resources ² McCoul, E.D., Anand, V.K. & Christos, P.J. (2012). Validating the Clinical Assessment of Eustachian Tube Dysfunction: The Eustachian Tube Dysfunction Questionnaire (ETDQ-7). The Laryngoscope, 122;

5 ETDQ-7 Tracking and Results Patient Name Patient # John Doe 1 Jane Doe 2 John Doe 3 Jane Doe 4 John Doe 5 Jane Doe 6 John Doe 7 Jane Doe 8 John Doe 9 Jane Doe 10 Pre-Procedure Score Date #1 Post-Procedure Score Date #2 Example: Tracking Spreadsheet Example: Patient Outcomes Graph that can be generated from the Tracking Spreadsheet 5

6 A Randomized Clinical Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (ELLIOTT) Clinical Evidence Study Methodology The study was a prospective, multi-center, randomized controlled trial to demonstrate superiority of the Eustachian tube balloon dilation with ETBC in conjunction with medical management compared to medical management alone.³ Instructions for Use ³ ACCLARENT AERA Eustachian Tube Balloon Dilation System Instructions for Use. Irvine, CA: Acclarent, Inc; IFU Rev D 6

7 A Randomized Clinical Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (ELLIOTT) Diagnosis and Main Criteria for Inclusion: Subjects age 22 and older diagnosed with persistent ETD. Persistent ETD is defined by patient-reported symptoms of ETD for 12 weeks or greater. Failure of medical management consisting of either a minimum of 4 weeks of continuous daily usage of any intranasal steroid spray or a minimum of one completed course of an oral steroid. Patients were required to have a computed tomography (CT) scan to confirm absence of internal carotid artery (ICA) dehiscence in the ET lumen. An abnormal tympanometry (type B or C) after failed medical management. Demonstrated symptomatic dysfunction as documented through a validated quality of life instrument (ETDQ-7) with a score 2.1 after failed medical management (within 90 days of study enrollment). Control Group: ETD treated with Medical Management alone ³ ³ ACCLARENT AERA Eustachian Tube Balloon Dilation System Instructions for Use. Irvine, CA: Acclarent, Inc; IFU Rev D 7

8 ETDQ-7 Clinical Updates Study 1 ROC* analysis supported the excellent discriminate validity of the ETDQ-7... This equated to an ETDQ-7 mean item score of 2.1 to indicate the presence of ETD. In particular, higher scores of ETDQ-7 were seen in association with higher scores on the SNOT-22, indicating a moderate degree of agreement with an established, validated measure of sinonasal morbidity Nonetheless, the correlation of higher SNOT-22 scores with higher ETDQ-7 suggests that sinonasal symptoms may have a causative effect on ETD ² ² McCoul, E.D., Anand, V.K. & Christos, P.J. (2012). Validating the Clinical Assessment of Eustachian Tube Dysfunction: The Eustachian Tube Dysfunction Questionnaire (ETDQ-7). The Laryngoscope, 122; Study 2 The mean overall change score at the first postoperative assessment was 1.9 points, which may be considered the clinically important difference for improvement ¹ ¹ McCoul, E.D. & Anand, V.K. (2012). Eustachian tube balloon dilation surgery. International Forum of Allergy & Rhinology, vol 2, * Receiver Operating Characteristic 8

9 Potential Sinus Candidates Current Patients Patient Identification 9

10 Federal (U.S.) law restricts the sale, distribution or use of the ACCLARENT AERA by or on the order of a physician who is trained in the use of Acclarent technology. Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury. Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings, and precautions associated with these devices. ACCLARENT AERA is intended for use by physicians who are trained on Acclarent technology. Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury. Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings, and precautions associated with these devices. 10