The Patient s Perspective
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- Myles Phelps
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1 The Patient s Perspective Patient Considerations for Healthcare Providers Amy Leitman Director of Policy & Advocacy NTM Info & Research NTM Lecture Series for Providers September 27, 2018
2 Disclosures No relevant financial disclosures to report I will be discussing off-label uses of the following medications: Amikacin Fluoroquinolones
3 Objectives o Review tools and resources available to providers, patients, and caregivers to help educate patients about their illness and treatments o Discuss patient experiences related to illness, treatments, and outcomes o Discuss the role of new regulatory initiatives in future research, clinical practice, and therapeutic development
4 NTM Info & Research a partnership with patients, providers, & researchers Co-founders: Patient & caregiver The website: The pamphlet: A resource for patients
5 Online Forum for Patients
6 Resources for Patients Local Support Groups Research Pipeline Page
7 Online Resources for Providers
8 Bronchiectasis & NTM Research Registry
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10 1,200 + members ~80% patients 121 Questions & Answers 41 Blog posts
11 Additional Resources for Patients
12 Live Events: NTM & Bronchiectasis Conference o CME-accredited Physician/Patient Conference o Mid-May, just prior to the start of ATS o ~300 attendees
13 Live Events: Town Hall Teleconferences Bronchiectasis & NTM 101 and A Dive Into Bronchiectasis & NTM Guest Speakers: Kevin Winthrop (OHSU) & Tim Aksamit (Mayo Clinic) Nearly 200 attendees for each event 2 Town Hall Events Nearly 600 registrants for each event 98% of post-event survey respondents found events valuable
14 Live Events: COPD, Bronchiectasis & NTM Webinar Guest Speaker: Chuck Daley (National Jewish Health) Over 300 attendees 1 Webinar Nearly 600 registrants 100% of post-event survey respondents found event valuable
15 NTM Research Consortium Ann Am Thorac Soc Vol 13, No 9, pp S379-S384, Sep 2016
16 Bronchiectasis Research Consortium 1. Improve treatment of bronchiectasis and prevent exacerbations 2. Improve treatment of exacerbations and associated infections 3. Improve health-related quality of life 4. Identify predictors of poor prognosis 5. Understand impact of underlying conditions 6. Conduct patient-centered clinical trials
17 Diagnosis: A Life-Altering Moment o What is it? o Am I contagious? o How will my life change? o Will my family help me? o Will my friends want to be around me? o Am I getting the correct treatment? o How long will I be on treatment? o What are the side effects? o Am I going to die from this? As a healthcare provider, you can strengthen the patient s support network by helping them educate their families on what this disease is and what it means for the patient and family.
18 Support: What Does It Mean? o Patients with supportive families who learn about NTM disease, and understand the importance of all aspects of treatment o Patients and families who understand daily changes in energy levels, the time constraints associated with the illness and its treatments o Marshal as many resources as possible (immediate family, friends, community, etc.) o Address concerns about all aspects of their health physical and mental
19 Patient Initiative: Taking Action Leads to improved quality of life NTM is not a passive disease But some patients are more active decision-makers/ participants in their own care than others. In addition to taking medicine, your patient must commit to: o Airway clearance o Nutrition o Exercise and fitness o Proper rest o Psychological support mechanisms
20 Trust Yourself, Trust Your Patient Listen to: o Your patient o Your patient s caregiver o Your patient s other healthcare providers work as a team Treating patients with pulmonary NTM disease is a commitment to working with them. You must ask them to commit to their health as well, and make them an active participant in their own care.
21 Patient-Focused Drug Development Patients reported these three symptoms as having the most significant clinical impact on their daily lives: o Cough o Fatigue o Shortness of breath Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). The voice of the patient: a series of reports from the U.S. Food and Drug Administration s (FDA s) Patient-Focused Drug Development Initiative: non-tuberculous mycobacterial (NTM) lung infection. Public Meeting: October 15, April [accessed 2016 April 30]. Available from:
22 I find the chronic fatigue very difficult to deal with. In social activities, I am often embarrassed because I have to excuse myself for a long period to cough and clear my lungs. it is very difficult to drive 50 miles I often have to stop after about 30 minutes and sleep for minutes, and then drive the rest of the way. To fix a meal I have to plan ahead. I make a fruit salad and then rest for an hour. I make a dessert and then rest an hour. Prolonged conversation gives shortness of breath. Driving difficulties from frequent disorientation. Exercise limitation due to weight loss. Limitation in enjoying social activities, travel and food. Omnibus document submitted by NTMir, Docket No. FDA-2012-N ; 79 Fed. Reg. 195 My worst thing is fatigue...
23 My keeping going has mostly to do with determination, rather than a lessening of the disease. I m always waiting for the other shoe to drop, afraid of the air, water and dirt around me. Omnibus document submitted by NTMir, Docket No. FDA-2012-N ; 79 Fed. Reg. 195
24 you have to work hard to keep a frown off of your face so that you don t bum out everyone who is around you... Omnibus document submitted by NTMir, Docket No. FDA-2012-N ; 79 Fed. Reg. 195
25 I feel sick all the time and depressed, I d rather die than [be] sick every day. Omnibus document submitted by NTMir, Docket No. FDA-2012-N ; 79 Fed. Reg. 195
26 How Depression and Chronic Disease are Linked Depressive symptoms are common in patients with COPD and those with severe COPD have a 2.5 times greater risk of developing depression. 1 Limitations on activity imposed by chronic medical illness may lead to gradual withdrawal from rewarding activities. 2 Major depression is associated with increased medical utilization and costs, higher symptom burden, increased functional impairment 3 and other decrements in quality of life, and increased rates of mortality. 4 Major depression is associated with 50% to 100% higher costs in medical patients even after controlling for associated medical illness. 5,6 1) Van Manen JG, et al. Risk of depression in patients with chronic obstructive pulmonary disease and its determinants. Thorax 2002;57: ) Prince M, et al. A prospective population-based cohort study of the effects of disablement and social milieu on the onset and maintenance of late-life depression. The Gospel Oak Project VII. Psychol Med 1998;28: ) Wells KB, Stewart A, Hats RD, et al. The functioning and well-being of depressed patients: Results from the Outcomes Study. JAMA. 1989; 262: ) Katon WJ. The depressed patient with comorbid illness. Program and abstracts of the 154 th Annual Meeting of the American Psychiatric Association; May 5-10, 2001; New Orleans, LA. Industry Symposium, Part 2, 43B. 5) Unutzer J, Katon W, Simon G, et al. Costs of medical care in an elderly primary care population. Presented at the 9 th annual meeting of the American Association of Geriatric Psychiatry; February 1996; Tucson, AZ. 6) Simon GE, Von Korff M, Barlow W. Health care costs of primary care patients with recognized depression. Arch Gen Psychiatry. 1995; 52:
27 LOOK and LISTEN Is your patient feeling OK? DEPRESSION plays a big role in chronic illness. How does your patient LOOK? Ask your patient how they re FEELING. LISTEN to their answers for signs of depression.
28 o o o What to Know, What to Do Depression can be exacerbated by fear, lack of knowledge, and the illness itself or its side effects The patient and their family may benefit from counseling and/or anti-depressant medications PLEASE DO NOT ignore this component talk to the patient about getting the mental health support they need for themselves and their family o Help your patient get educated about their illness 1 o o Work with your patient s other physicians; nearly 50% of patients with clinical depression are first diagnosed by a primary care physician 2,3 Most prefer to receive mental health care within the primary care setting because it is perceived as less stigmatizing 2,3 1) Zhang Q, et al. Disease knowledge level is a noteworthy risk factor of anxiety and depression in patients with chronic obstructive pulmonary disease: a cross-sectional study. BMC Pulmonary Medicine 2014, 14:92. 2) Mental Health Care Services by Family Physicians Position Paper. American Academy of Family Physicians web site. Accessed October 4, ) Position Statement 13. Integration of Mental and General Health Care. Mental Health America web site. Accessed October 4, 2017.
29 Depression Screening (WHEN) Patients should be screened for depression at every visit. Challenges in Screening: o Standard screening tools may not catch it 1 o Side effect and disease symptoms may mimic depression symptoms, and vice versa 1) Wilson, I. Int l J. COPD 2006:1(1)
30 What to Look For o Sadness o Anxiety/Fear o Social isolation o Anger o Sleep disruption (too much or too little) o Feeling of not wanting to get up or go on o Suicidal thoughts or ideations
31 What to Ask, How to Ask American Heart Association 2-item Patient Health Questionnaire screens feelings, mood and anhedonia (PHQ-2) AHA s 9-item questionnaire (PHQ-9) Some questions will be more instructive than others, and some questions will require immediate follow-up questions for clarification
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34 Regulatory Update: Patient-Focused Drug Development Inhaled antibiotics for the treatment of Pseudomonas aeruginosa Patient Survey results January 19, 2018
35 Regulatory Update: Patient-Focused Drug Development Inhaled antibiotics for the treatment of Pseudomonas aeruginosa U.S. Food & Drug Administration. Public Workshop, Development of Inhaled Antibacterial Treatments for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis. Accessed September 6, Werble C. Breathing Life Into Inhaled Antibiotics. Pink Sheet, July 23, Accessed September 6, 2018.
36 Regulatory Update: R&D Pipeline That s Dr. Kasperbauer and that s Dr. Griffith! Inhaled liposomal amikacin for the treatment of refractory Mycobacterium avium complex U.S. Food & Drug Administration Advisory Committee Meeting, August 7, 2018.
37 Regulatory Update: Patient-Focused Drug Development U.S. Food & Drug Administration. Patient-Focused Drug Development: Collecting Comprehensive and Representative Input. mplianceregulatoryinformation/guidances/ucm pdf. Accessed September 6, o First of four draft documents on PFDD o Guidance 1: methodologies for collecting, analyzing, and disseminating patient experience data o Guidance 2: developing best practices in design and execution of PE research o Guidance 3: deciding what to measure and developing fit-forpurpose COAs o Guidance 4: deciding what is an appropriate clinical trial endpoint
38 Regulatory Update: FDA Drug Safety Warning U.S. Food & Drug Administration. Accessed September 6, 2018.
39 Please Join Us on May 17, 2019 for our Physician/Patient Conference NTM Info & Research and University of Texas Health Science Center, Tyler Gaylord Texan Resort, Grapevine, TX
40 THANK YOU
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