The Association Between Smoking Status And Quality Of Life: Factoring In Lifestyle Variables

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health-related quality of life via multiple instruments in patients with CF. Sponsored by Vertex Pharmaceuticals Incorporated. PRS41 An Approach To Evaluating The Usefulness Of Supplementing The Eq5d Descriptive System In Obstructive Pulmonary Disease Law EH, Joo MJ, Vinicky M, Pickard AS 1University of Illinois at Chicago, Chicago, IL, USA

Objectives: We sought to outline a methodology to explore whether self-rated health was adequately explained by the five core dimensions of the EQ5D in a specific patient group, namely patients with obstructive pulmonary disease.  Methods: Fifty-eight patients concurrently enrolled in a trial completed the EQ5D-5L at baseline, which was modified to include an experimental Breathing item (“EQ-5D-5L-B”) The items were entered as covariates in multiple regression analysis, with visual analogue scale (VAS) score as the dependent variable. Each dimension was coded as dichotomous variable: “no problems” or “any problems”. Various model specifications that included the main effects plus interactions were explored.  Results: The ability of the EQ5D-5L to explain self-rated health (R2 =  20%) did not improve with the addition of a Breathing dimension. The most parsimonious model only included Mobility and Usual Activity (R2 =  19%). In this model, patients who reported any limitations in Mobility or Usual Activity were expected to experience an average decrease of 11.0 (p= 0.02) or 7.6 (p= 0.1) points in the VAS score, respectively. The model that included a Mobility/Usual Activity interaction demonstrated greater explanatory power (R2 =  25%).  Conclusions: This pilot study illustrated an approach to evaluating whether supplementing the EQ-5D descriptive system with additional item(s) in a disease-specific context. The addition of a “Breathing” item did not help to explain self-rated health, which did not encourage further development of a supplement to the core items. Limitations include small sample and that the ability to explain self-rated health is one of many options for evaluating the usefulness of descriptive system supplementation. PRS42 The Association Between Maternal Smoking During Pregnancy And Child Quality-Adjusted Life Years Hartman JD1, Craig BM2, Blackburn C1, Simmons V1 Cancer Center, Tampa, FL, USA, 2Department of Economics, University of South Florida, Tampa, FL, USA 1Moffitt

Objectives: Examining losses in childhood health-related quality of life associated with maternal smoking provides parents and policymakers another tool for the valuation of smoking cessation during pregnancy. This study advances previous work comparing childhood behavioral problems and maternal smoking by estimating the loss in quality-adjusted life years (QALYs) for the child.  Methods: Using the National Longitudinal Survey of Youth 1979 Child and Young Adult data, this study retrospectively examined a cohort of 4114 mothers and 8668 children. In addition to questions focusing on maternal smoking and general demographics, each survey included the Behavior Problems Index (BPI), a 28-item questionnaire with six subscales measuring childhood behavior problems (Antisocial Behavior, Anxiousness/Depression, Headstrongness, Hyperactivity, Immature Dependency, and Peer Conflict/Social Withdrawal). Responses to the BPI, completed by mothers with children ages 4-14, were summarized on a QALY scale using published preference weights.  Results: Children whose mothers smoked during pregnancy experience additional QALY losses of 0.181, on average, per year due to increased behavior problems. Boys suffered larger QALY losses associated with maternal smoking (0.242) compared to girls (0.119; p value =  0.021), regardless of age. Moreover, heavier smoking during pregnancy (i.e., 1 or more packs per day) was associated with larger QALY losses (0.282; p-value < 0.001).  Conclusions: These findings illustrate the burden of maternal smoking during pregnancy on child health, namely behavioral problems. These losses in QALYs may be incorporated into economic evaluations for smoking cessation interventions during pregnancy. Future research will investigate how maternal smoking following childbirth is associated with child QALYs. PRS43 Exploring The Qualitative Experience Of Chest Congestion With Children And Adults To Develop Patient-Reported Outcome Items To Self-Assess Symptoms Of The Common Cold Grant L1, Marshall C1, Burrows K1, Khammo N2, Albrecht H3, Arbuckle R1, Shea T4 Ltd, Bollington, UK, 2RB, Hull, UK, 3Florida International University, Miami, FL, USA, 4RB, Parsippany, NJ, USA 1Adelphi Values

Objectives: Chest congestion symptoms, commonly experienced as part of the common cold/upper respiratory tract infections (URTI), can be difficult to observe, complex to describe, and can overlap with other symptoms (e.g. cough). To support future efficacy studies for expectorant drugs, an appropriately developed and validated subjective assessment of chest congestion and related-symptoms is therefore necessary. The current research explored the qualitative experience of chest congestion to develop patient-reported outcome items with strong content validity for use with children and adults.  Methods: Semi-structured, face-to-face, qualitative interviews were conducted with 49 individuals with either a current cold (n= 38) or recent cold (n= 11). The sample included 39 children/adolescents (aged 6-17 years old) and 10 adults from two locations in the US. The participants were asked openended, exploratory questions about their experience of chest congestion. Creative methods and pictograms, including drawing and animal tasks were used to aid discussions.  Results: Eight concepts related to the experience of chest-congestion were reported by participants: difficulty breathing, chest tightness, chest heaviness, ‘stuff’ in chest, chest pain, stuffed up or clogged up, difficulty clearing mucus and noise when breathing. Difficulty breathing and difficulty clearing mucus were the most frequently experienced chest symptoms across all age groups. Descriptions for difficulty clearing mucus varied by age, with younger children using words such as ‘goo’ and ‘gunk’ to describe the mucus. Chest pain was reported spontaneously by almost half of the sample but was frequently associated with another symptom

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(e.g. cough). The more complex concepts of ‘chest heaviness’ and ‘chest tightness’ were experienced by participants of all ages, but were rarely reported spontaneously by the younger children.  Conclusions: There was consistency in the symptoms reported by children and adults but younger children were less likely to spontaneously report the more complex symptoms. Using age-appropriate language, pictograms and creative tasks can help elicit content from younger children. PRS44 Rescue Medication Use In Copd: Payer And Regulatory Perspective Sharma S1, Kalra M1, Thakur C1, Punekar YS2 Consulting, Chandigarh, India, 2GlaxoSmithKline, Uxbridge, UK

1Parexel

Objectives: To understand the importance of rescue medication use (RMU) from payer and regulatory perspective.  Methods: Electronic databases (Embase®, MEDLINE®, MEDLINE® In-Process), HTAs, guidelines and clinicaltrial.gov registry were searched and bibliography search of included publications was conducted. Single review methodology was followed by quality check; there was no restriction on publication timeframe and study design. Only studies in English language were included.  Results: EMA recognizes rescue use as a clinical endpoint and regulatory authorities are encouraging pharmaceutical companies to incorporate PRO data within their product submissions. The results from clinicaltrial.gov suggest that the use of RMU as an endpoint has increased in the last 5 years for clinical trials in COPD. In the year 2015, 15 trials assessed RMU as an endpoint in COPD trials compared to five in 2005. The review observed that RMU was assessed as an end-point in 49 out of 116 studies in COPD over the last two years (2013-2015). Recent studies have included RMU along with established PROs such as SGRQ, TDI and exacerbations. Studies have demonstrated association between RMU and improvements in FEV1 or exacerbations. Two studies have also used RMU as an attribute in economic modelling studies. Another study also observed that willingness to pay based on monthly co-pay dollars was $32 to rarely use rescue medication, varying with severity of COPD and indicated rescue medication as an important patient preference.  Conclusions: RMU is frequently used as a nonprimary endpoint in clinical trials of COPD but appears to be a neglected endpoint for consideration in payer submissions. There is a need for further research to explore the association of RMU with other established PROs and demonstrate its importance to payers. PRS45 Development Of A Report Card For Identifying Local Sublingual Immunotherapy Events In Clinical Trials Norquist JM1, Tanzosh T1, Flood E2, Li H1, Iskold B1, Ganser TR2, Marson-Smith HR2 1Merck & Co, Whitehouse Station, NJ, USA, 2ICON COA, Gaithersburg, MD, USA

Objectives: Develop the Sublingual Immunotherapy (SLIT) Report Card to capture patient-reported local reactions associated with the administration of sublingual immunotherapy, based on the World Allergy Organization’s (WAO) side effect grading system.  Methods: Items were drafted based on the WAO grading system. Cognitive debriefing, usability testing interviews, and translatability assessment were conducted. Adults (aged 18+ y), adolescents (aged 12-17 y), and parents/ caregivers and their children (aged 5-11 y) participated in two rounds of interviews. A paper version of the SLIT Report Card was tested in Round 1, and both paper and electronic versions were further evaluated in Round 2. Interviews were conducted to confirm appropriateness and comprehension of the instrument’s content and, for the electronic version, ease of completion using the electronic device. A translatability assessment enabled identification and mitigation of potential issues that might arise during future translation and linguistic validation.  Results: Ten adults, 10 adolescents, and 10 parent/child dyads participated in interviews. In general, subjects interpreted the instrument and instructions as intended, and were able to demonstrate understanding by explaining the meaning of the instrument’s content. However, some adult, adolescent and parent/ child subjects were uncertain of, or suggested clarifying, the meaning of certain terms, including tablet, ulcer, taste alteration, uvula, nausea, and itching in the ear. The translatability assessment also identified uvula and nausea as potentially problematic with respect to translation. Subjects were able to use the device and found navigation of the instrument ‘easy’, with only a few minor suggestions made to improve usability. Some wording and formatting changes were made based on subject feedback and the translatability assessment.  Conclusions: The SLIT Report Card was refined following best practices for instrument development. The refined SLIT Report Card is appropriate for systematically collecting data on SLIT-related local reactions directly from subjects in a clinical trial setting, based on the WAO grading system. PRS46 The Association Between Smoking Status And Quality Of Life: Factoring In Lifestyle Variables Brown B, Nduaguba SO, Rascati K, Ford K The University of Texas at Austin, Austin, TX, USA

Objectives: Smoking status, which has been shown to be associated with quality of life (QoL), may be associated with other lifestyle factors. Yet, most studies assessing the relationship between smoking status and QoL fail to account for other health-related lifestyle factors. This study’s objectives were to assess 1) the relationship between smoking status and other health-related lifestyle factors (flu vaccination, alcohol use, and physical activity) and 2) how these factors affect model fit.  Methods: Data were extracted from the 2014 Behavioral Risk Factor Surveillance Survey dataset (N= 332,680). Chi-square was used to address the first objective. For the second objective, quality of life, measured using eight domains (general health, physical health, mental health, activity limitations, pain, depressive symptoms, anxiety, and vitality) dichotomized into frequent positive (≥ 14 days/ month) and negative (< 14 days/month) experience was regressed on smoking status controlling for age, race, gender, education, marital status, income, employment,

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healthcare coverage, comorbidity, and body mass index (Model 1). Lifestyle factors were included in a second model.  Results: Compared to non-smokers and current smokers, former smokers were more likely to have at least one chronic condition (p< 0.001) and get a flu vaccination (p< 0.001). However, non-smokers were more likely to have avoided alcohol (p< 0.001) and engaged in physical activity in the past month (p< 0.001). For all eight QoL measures, Model 2 fit significantly better than Model 1 (p< 0.001). The relationship between smoking status and QoL remained in model 2 with the odds of frequent positive experience being significantly lower for smokers on all QoL measures except vitality (p< 0.001) and significantly lower on general, physical, and mental health for former smokers (p< 0.05), compared to non-smokers.  Conclusions: Further research is needed to determine if the decision to quit smoking coincides with the decision to make other lifestyle changes as this might suggest the need for more comprehensive smoking cessation programs. PRS47 Systematic Review Of Health-Related Quality Of Life In Patients With Pulmonary Arterial Hypertension Gu S1, Hu H2, Dong H3 1Zhejiang University, Hangzhou, China, 2Zhejiang Medical College, Hangzhou, China, 3Zhejiang Univerisity, Hangzhou, China

Objectives: Lengthened survival in pulmonary arterial hypertension (PAH) has shifted attention towards disease burden that PAH imposes on patients and healthcare systems. Currently, most available studies emphasize epidemiology, clinical characteristics and medications of PAH; while large observational studies reporting real-world health-related quality-of-life (HRQOL) of patients with PAH are lacking. Thus this study aims to study real-world HRQOL of patients with PAH, and summarise factors influencing it.  Methods: Systematic literature searches were conducted in English-language databases (PubMed, Web of Knowledge, ScienceDirect and OVID) and Chinese-language databases (China National Knowledge Infrastructure, Wanfang Data, Chongqing VIP and SinoMed) to identify observational studies (2000-2015) assessing HRQOL of patients with PAH. Search results were independently reviewed and extracted by two reviewers who then evaluated the study quality.  Results: Of 3392 records identified in initial search, 20 eligible papers (19 English, 1 Chinese) were finally included. Studies used a range of instruments; the generic 36-item Short Form Survey (SF-36) was the most widelyused, followed by disease-specific Cambridge Pulmonary Hypertension Outcome Survey (CAMPHOR). Mean HRQOL scores assessed by SF-36 (physical component summary: 25.4-80.1; mental component summary: 33.2-76.0) and CAMPHOR (symptom scores: 3.1-17; total HRQOL: 2.8-12.6; activity scores: 3.8-18.1) varied across studies, reporting decreased physical, emotional and overall HRQOL in patients. Patients experienced a constellation of profound symptoms even with optimal PAH therapy, including dyspnea with activity, fatigue and sleep difficulty. Mental health (depression, anxiety, stress), physical health (exercise capacity, symptoms) and medical therapies were reported to affect HRQOL.  Conclusions: The disease burden of PAH is substantial regarding decreased HRQOL of patients. Opportunities for improvement exist with advanced new treatments and improved disease management. The paucity of large observational evidence in this area requires researchers’ attention, especially in China.

RESPIRATORY-RELATED DISORDERS – Health Care Use & Policy Studies PRS48 Predictors Of Low Patient Activation When Initiating C1 Esterase Inhibitor Therapy For Hereditary Angioedema Cross N1, Hanna D1, Eaddy M2, Nunna S3, Rane P4 1Lash Group, Frisco, TX, USA, 2Xcenda, LLC, Palm Harbor, FL, USA, 3University of Mississippi, University, MS, USA, 4University of Houston, Houston, TX, USA

Objectives: Achieving healthcare quality improvements and cost reduction necessitates the participation of activated and informed consumers and patients. Identifying factors leading to low patient activation could help optimize interventions to increase the quality of healthcare. This study attempted to identify predictors of low patient activation measures (PAMs) among patients initiating C1 esterase inhibitor (recombinant) (C1-INH) for the treatment of hereditary angioedema.  Methods: A prospective study administering a self-reported PAM survey to patients initiating C1-INH for the treatment of hereditary angioedema was conducted. Patient age, gender, treating physician specialty, region, and payer type were collected and evaluated as potential predictors of PAM levels. Patients were grouped into 3 mutually exclusive cohorts: low patient activation ≤ 2, moderate patient activation = 3, and high patient activation = 4. Due to the rare nature of hereditary angioedema, standardized differences between available factors across PAM level cohorts were computed using PAM level 4 as the reference cohort.  Results: There were 94 patients included in the analysis, with the majority being female (74.5%), having a mean age of 40 years, and being from the southern region (40.4%) privately insured (61.7%). The majority of patients were in PAM level 4 (58.5%) followed by PAM level 3 (30.9%) and PAM level ≤ 2 (10.6 %). Compared to patients in PAM level 4, patients in PAM level ≤ 2 were more likely to be younger (35.7 vs 38.9; standardized difference [SD]= 20.2); however, patients in PAM level 3 were older compared to patients in PAM level 4 (43.7; SD= 29.4). Patients in PAM level 3 also had the highest proportion of females compared to patients in PAM level ≤ 2 (79.3% vs 60%; SD= 41.3).  Conclusions: Younger age and being male were associated with the lowest level of patient activation when initiating C1-INH for the treatment of hereditary angioedema. PRS49 Patient Comfortability In Administering C1 Esterase Inhibitor Therapy For Hereditary Angioedema: An Evaluation Of Patient Activation And Adherence Cross N1, Hanna D1, Eaddy M2, Rane P3

1Lash Group, Frisco, TX, USA, 2Xcenda, LLC, Palm Harbor, FL, USA, 3University of Houston, Houston, TX, USA

Objectives: Specialty therapies are increasingly being self-administered, requiring patients and caregivers to have a thorough understanding of reconstituting and injecting these medications. This study measures treatment adherence evaluated by the use of a patient activation measure (PAM) and administration comfortability of C1 esterase inhibitor therapy for hereditary angioedema patients.  Methods: Hub-enrolled patients diagnosed and prescribed C1 esterase inhibitor therapy were segmented utilizing the PAM and then trained on reconstituting and administering the therapy by field education nurses. Patients demonstrating an adequate ability to administer therapy were deemed “comfortable.” Those deemed “uncomfortable” had family members trained to administer therapy, or treatment was administered on demand by healthcare professionals. Based on baseline PAM levels, patients were provided tailored call cadence schedules to uncover limiting self-administration barriers for level 1 and 2 patients and continuing education for level 3 and 4 patients. All patients were followed prospectively to assess treatment utilization and adherence (medication possession ratio).  Results: 42 patients were included in the study, with the majority being female (70.5%) and a mean age of 38.8 years. Of the 42 patients, 29 (69.1%) were deemed comfortable with therapy administration and 88.1% of patients fell into a PAM level 3 or 4. Patients deemed uncomfortable with therapy administration subsequently received more training compared to comfortable patients (1.38 vs 1.1; standard deviation [SD]= 36.2). Comfortable level 3 and 4 patients receiving continuing education resulted in lower mean adherence (0.40 vs 0.50; SD= 20.5) as their knowledge, skill, and confidence around awareness and management of their condition improved. Uncomfortable patients had higher mean adherence, which may represent lesser confidence and knowledge of managing their condition.  Conclusions: In hereditary angioedema, patient product comfortability and activation at baseline are key predictors of subsequent treatment utilization and may be correlated to higher disease burden. PRS50 The Coverage Of Cessation Medications Among Employer- Sponsored Insurance: An Environmental Scan Before The Enactment Of The Affordable Care Act Xu X1, Asman K2, Malarcher AM1, Naavaal S1, Jamal A1, Neff L1, Babb SD1 for Disease Control and Prevention, Atlanta, GA, USA, 2RTI International, Atlanta, GA, USA 1Centers

Objectives: Tobacco smoking is the leading cause of preventable disease and death in the United States. Tobacco cessation has major and immediate health benefits. The Patient Protection and Affordable Care Act of 2010 (ACA) requires nongrandfathered private health plans (i.e., new plans or those changed substantially since March 2010) to cover certain recommended evidence-based clinical services, including tobacco cessation. A guidance document issued in May 2014 defined these interventions to include cessation counseling and seven Food and Drug Administration (FDA) approved medications. We evaluated cessation medication coverage among employer-sponsored insurance (ESI) before ACA enactment.  Methods: Data from the 2010 Truven MarketScan® Databases were used to assess plans’ coverage of five formulations of nicotine replacement therapy (patch, gum, lozenge, nasal spray, and inhaler), varenicline, and bupropion. Since the Benefit Plan Design database does not directly include indicators of smoking-cessation coverage, identifiable plans with reimbursements for specific medication claims were classified as covering that medication. The sample was limited to pharmaceutical claims from 58,230 persons aged 35-64 years old. Bupropion claims were restricted to the 150mg 12-hour extended release formulation (primary formulation recommended for cessation).  Results: A total of 109 insurance plans were identified, which were all self-insured health plans. Only 2 plans covered all 7 FDA-approved medications; both were Health Maintenance Organizations (HMOs). Another 86 plans covered 2 to 6 of these medications; approximately 87% of the enrollees in these plans were covered by either HMO or Preferred Provider Organizations. The remaining 21 plans either covered bupropion only, which could also be prescribed as an antidepressant, or did not cover any tobacco cessation medication. Tobacco cessation coverage varied widely by industry classification and employers’ state of residence.  Conclusions: Tobacco cessation coverage was limited among ESI before ACA enactment. Continued monitoring is important to track anticipated improvements in cessation coverage after ACA implementation. PRS51 Burden Of Illness Associated With Moderate To Very Severe Chronic Obstructive Pulmonary Disease Singh M1, Baculea S1, Quigley JM1, Bergstrom G2, Holmgren U2 Clinical Research UK Ltd, Abingdon, UK, 2AstraZeneca, Mölndal, Sweden

1ICON

Objectives: COPD is a severe respiratory disorder and a major cause of chronic morbidity and mortality worldwide. The objective is to assess the burden of illness (BOI) associated with moderate to very severe COPD in the US, Canada, UK, France, Italy, Germany, Spain and Australia.  Methods: Two targeted literature reviews in a systematic framework were performed. The searches were performed in Medline, Medline in process and Embase databases to identify humanistic and economic burden publications from the last 10 years; additional searches on EconLit and NHS EED were performed for further identifying articles specific to the economic burden.  Results: In total 4981 abstracts were identified and screened. Seventeen articles were included for the humanistic burden and 24 for the economic burden. COPD is associated with substantial humanistic burden. Patients with COPD experience an impaired Health Related Quality of Life (HRQoL), in both their physical and mental health. Dyspnoea and exacerbations are major drivers of the humanistic burden. In addition, the early morning, daytime and night-time COPD symptoms pose a significant burden on patients, as they greatly affect their sleep quality and physical activity level, and are associated with worse dyspnoea, health status and higher anxiety and depression levels. COPD poses a significant burden on healthcare budgets. This is primarily driven by the high prevalence of the disease and its