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Although insomnia is a common core symptom of major depressive disorder (MDD), the burden of moderate-to-severe insomnia symptoms in patients with MDD is not well-understood. This study quantified the clinical, patient-centric, and economic burden of adults with MDD with moderate-to-severe insomnia symptoms (MDDIS) compared to adults with MDD with no-to-mild insomnia symptoms (other-MDD) and adults without MDD.Data from 2019 US National Health and Wellness Survey identified adults self-reporting physician-diagnosed depression, stratified by insomnia status (MDDIS: Insomnia Severity Index [ISI] score ≥15; other-MDD: ISI score 15), and adults not reporting depression (non-MDD). Other-MDD and non-MDD were matched 2:1 to MDDIS on age/sex/race. Matched bivariate analyses examined differences in health-related outcomes by depression-insomnia status.Of 74,994 survey respondents, 2045 (2.7%) were classified as MDDIS, 8220 (11.0%) as other-MDD, and 59,859 (79.8%) as non-MDD. MDDIS respondents (vs other-MDD and non-MDD) reported greater depression severity, anxiety severity, daytime sleepiness, activity impairment, direct costs, and costs due to work productivity impairments, and lower mental and physical functioning (all P 0.05).Depression diagnosis was not based on clinical/diagnostic interview; causal relationships cannot be determined due to the cross-sectional design.Among US adults with MDD, presence of moderate-to-severe insomnia symptoms is associated with additional burden and notable impairments across several health outcomes versus those with MDD but no-to-minimal insomnia symptoms and general population without MDD. This study highlights the burden of MDDIS and the need for better identification and management of moderate-to-severe insomnia symptoms in adults with MDD.

The goal of this study was to understand the preferences of patients and physicians for the benefits and risks associated with the treatment of advanced breast cancer that expresses normal amounts of the HER2 protein (termed as HER2 negative). Respondents completed an exercise where they compared two treatment options at a time that varied in their level of effectiveness and their potential for certain side effects and then selected the treatment option they most preferred. From this exercise, the treatment features that matter the most to patients and physicians were discovered. The most important treatment features for patients were lengthening life expectancy, decreasing the chance of experiencing nausea affecting appetite, and decreasing the chance of experiencing nerve damage involving numbness and/or pain, possibly severe, in hands and feet which may limit daily activities. The most important treatment features for physicians were lengthening life expectancy, decreasing the change of experiencing nerve damage involving numbness and/or pain, possibly severe, in hands and feet which may limit daily activities, and lengthening the time that cancer remains stable and does not worsen. Patients and physicians also rated how much they agreed with statements about their goals for treatment. While 67% of oncologists believed that their patients are more focused on killing the cancer than their quality of life, only 27% of patients were more focused on killing the cancer than their quality of life.

Plain language summary Maintenance therapy is a treatment option intended to keep ovarian cancer from coming back or getting worse for as long as possible after responding to chemotherapy. PARP inhibitors are a new type of maintenance therapy for ovarian cancer. This study aimed to understand the patients' and physicians' preferences for the benefits and risks associated with different PARP inhibitors used as maintenance therapy for ovarian cancer. Participants were asked to compare various treatment options based on their different safety profiles, effectiveness and form of medication (e.g., three capsules by mouth once a day versus two tablets by mouth twice a day), and then choose the treatment they most preferred. Through this exercise, the treatment features that mattered most to patients and physicians were identified. The most important treatment feature for patients was decreasing the chance of experiencing a serious side effect that requires medical intervention or hospitalization. In contrast, physicians valued lengthening the time that a cancer remains stable and does not worsen. To accept a 37% higher chance of experiencing a side effect that requires medical intervention or hospitalization, patients expect their cancer to remain stable and not worsen for an additional 28 months. This was a large difference from the 6 months that the physicians would consider as acceptable. The least important treatment features for patients are the amount of pills required per dose, the form of the given medication (e.g., tablet vs capsule) and the schedule of taking the treatment. On the other hand, physicians were least concerned about lowering the risk of experiencing low blood counts that, requiring medical intervention.

The ObserVational survey of the Epidemiology, tReatment and Care of MigrainE (OVERCOME; United States) study is a multicohort, longitudinal web survey that assesses symptomatology, consulting, diagnosis, treatment, and impact of migraine in the United States.Regularly updating population-based views of migraine in the United States provides a method for assessing the quality of ongoing migraine care and identifying unmet needs.The OVERCOME (US) 2018 migraine cohort involved: (I) creating a demographically representative sample of US adults using quota sampling (n = 97,478), (II) identifying people with active migraine in the past year via a validated migraine diagnostic questionnaire and/or self-reported medical diagnosis of migraine (n = 24,272), and (III) assessing consultation, diagnosis, and treatment of migraine (n = 21,143). The current manuscript evaluated whether those with low frequency episodic migraine (LFEM; 0-3 monthly headache days) differed from other categories on outcomes of interest.Among the migraine cohort (n = 21,143), 19,888 (94.1%) met our International Classification of Headache Disorders, 3rd edition-based case definition of migraine and 12,905 (61.0%) self-reported a medical diagnosis of migraine. Respondents' mean (SD) age was 42.2 (15.0) years; 15,697 (74.2%) were women. Having at least moderate disability was common (n = 8965; 42.4%) and around half (n = 10,783; 51.0%) had consulted a medical professional for migraine care in the past year. Only 4792 (22.7%) of respondents were currently using a triptan. Overall, 8539 (40.4%) were eligible for migraine preventive medication and 3555 (16.8%) were currently using migraine preventive medication. Those with LFEM differed from moderate and high frequency episodic migraine and chronic migraine on nearly all measures of consulting, diagnosis, and treatment.The OVERCOME (US) 2018 cohort revealed slow but steady progress in diagnosis and preventive treatment of migraine. However, despite significant impact among the population, many with migraine have unmet needs related to consulting for migraine, migraine diagnosis, and getting potentially beneficial migraine treatment. Moreover, it demonstrated the heterogeneity and varying unmet needs within episodic migraine.

Sanjay K Bajpai,1 M Janelle Cambron-Mellott,2 Oliver Will,2 Jiat-Ling Poon,1 Qianqian Wang,1 Beth D Mitchell,1 Eugenia Y Peck,2 Jane Babrowicz,2 Nedina K Raibulet,1 Christopher J Child,1 Kathleen Beusterien2 1Eli Lilly and Company, Indianapolis, IN, USA; 2Cerner Enviza, New York, NY, USACorrespondence: Sanjay K Bajpai, Eli Lilly & Company, 893 S Delaware St, Indianapolis, IN, 46225, USA, Tel +1 317 931 9828, Email sanjay.bajpai@lilly.comBackground: For individuals managing diabetes, the administration of glucagon for severe hypoglycemia can be lifesaving, yet, until recently, there were no easy-to-use devices for these stressful emergencies. New products have emerged to meet this need, including nasal glucagon (NG) and auto-injector glucagon (AI). This study evaluated the psychometric properties of a new measure, the Glucagon Device Attitudes Questionnaire (GDAQ), in assessing attitudes toward NG and AI from the perspectives of persons with diabetes on insulin (PWDs), caregivers, and acquaintances.Methods: Developed based on qualitative research, the GDAQ consists of 38 rating items for each device and 16 direct-elicitation of attitudes of device relative to each other. It was administered to participants via a cross-sectional online survey. Twenty-six rating items were included in principal component analysis and confirmatory factor analysis. Items comprising each factor were averaged to form scales. Additionally, 12 direct elicitation items were averaged to form an overall “Attitudes” scale. Reliability and validity analyses were conducted. Descriptive statistics were provided for the rating items not included in the factor analysis.Results: A total of 405 PWDs, 313 caregivers, and 305 acquaintances participated. Three factors were identified: “Prepared and Protected” (7 items), “Hesitation” (12 items), and “Device Perceptions by Others” (7 items); factor loadings ranged from 0.13 to 0.92, 0.50 to 0.89, and 0.16 to 0.92, respectively. Cronbach’s alpha for the four scales ranged from 0.76 to 0.96. Correlations of the scales with their global item ranged from 0.30 to 0.90. The items outside of the factor analysis showed good distribution in responses and differentiation between the two devices.Discussion: This study supports the validity and reliability of the GDAQ, which successfully conceptualizes attitudes towards devices for administering glucagon among different respondent groups. Use of the GDAQ can help guide the development and testing of new glucagon drug/device combinations.Keywords: diabetes, severe hypoglycemic events, glucagon delivery device, patient attitudes

International audience; ObjectivesThe treatment paradigm in newly diagnosed multiple myeloma (NDMM) is evolving toward individualized, risk-directed, and longer duration of therapy (DOT). The objective of this study was to describe treatment patterns and outcomes in non-transplant NDMM in four European countries.MethodsThis retrospective chart review included adults with NDMM diagnosed between January 1, 2012, and December 31, 2013 (early cohort), or April 1, 2016, and March 31, 2017 (recent cohort).ResultsAmong 836 patients, molecular testing was performed in 21% and 35% patients of early vs recent cohorts; proteasome inhibitor (PI)/alkylator combinations were the principal first-line (1 L) therapy (39% vs 43%). Use of immunomodulatory drug (IMID)/alkylator combinations declined from early to recent cohort (26% vs 13%) but IMID (7% vs 16%) use increased. Few patients (5%) received 1 L maintenance therapy. Two-thirds of patients were treated with a fixed duration intent, with a median 7-month 1 L DOT and progression-free survival (PFS) of 32.8 months in the early cohort. Both 1 L DOT and PFS were longer with oral compared to injectable regimens.ConclusionsAlthough frontline treatment patterns changed significantly, 1 L DOT is short. The uptake of molecular testing and 1 L maintenance is low. These results highlight areas of unmet need in NDMM.

To characterize burden of migraine in prevention-eligible patients compared with prevention non-eligible patients in the United States (US). Receipt of preventive therapy was also examined among prevention-eligible patients. This retrospective study utilized data from the 2017 US National Health and Wellness Survey linked with medical and pharmacy claims. Patients aged ≥18 years who self-reported experiencing migraine and had confirmed evidence of migraine (≥1 medical or pharmacy claim) were included. Prevention eligibility was based on number of headache days in the past 30 days (prevention-eligible: ≥4 and prevention non-eligible: pp=.002) and activity days lost due to migraine (18.39 ± 28.08 vs. 10.69 ± 21.43, p=.015) than those not receiving preventive therapy. Prevention-eligible patients experience greater burden due to migraine, including more headache days, worse health-related quality-of-life, and greater work and activity impairment than prevention non-eligible patients.

Objective/Background: Evaluate the impact of excessive daytime sleepiness (EDS) severity on burden of illness among adults with obstructive sleep apnoea (OSA) in European Union 5 (EU5) countries (France, Germany, Italy, Spain, United Kingdom). Patients/Methods: This retrospective observational study used data from the 2017 EU5 National Health and Wellness Survey, a self-administered, internet-based, non-screening survey. Respondents who self-reported both having experienced OSA in the last 12 months and having had their OSA diagnosed by a physician were considered to have OSA. Respondents completed the Epworth Sleepiness Scale (ESS) and were consequently categorised into 4 groups: OSA-with-EDS (ESS >10) subdivided by EDS severity (mild [ESS = 11–12], moderate [ESS = 13–15], severe [ESS = 16–24]), and OSA-without-EDS (ESS ≤10). Bivariate and multivariable analyses examined group differences in health-related quality of life (HRQoL), work productivity and activity impairment, and health care utilisation. Results: The analysis included 2008 respondents with OSA: n = 661 (32.9%) with EDS (29.5% mild, 34.5% moderate, 36.0% severe) and n = 1347 without EDS. Compared with the OSA-without-EDS group, the OSA-with-EDS subgroups generally had higher rates of obesity, depression, and other reported comorbidities. Greater severity of EDS was associated with worse self-reported HRQoL (all domains, P < 0.001) and work productivity and activity impairment (absenteeism, P = 0.031; presenteeism, overall work impairment, and non–work activity impairment, P < 0.001), as well as increased numbers of health care provider visits (P < 0.001). Conclusions: Compared to patients with OSA but without EDS, those with EDS had substantially higher socioeconomic and humanistic burden of disease, which was more profound among those reporting greater EDS.

OBJECTIVE To investigate the predictive factors associated with physical impairment among older patients with type 2 diabetes mellitus (T2DM) in Japan and to examine the potential impact of physical impairment on patient-reported health outcomes in this population. METHODS A cross-sectional analysis was conducted using patient-reported data from the 2012-2014 Japan National Health and Wellness Survey. Physical impairment was measured using the Physical Component Summary (PCS) score of the Short-Form 36-Item Health Survey (SF-36) three-component model (using Japanese norms). Older T2DM patients (≥65 years old; n = 1511) were dichotomized into physically impaired (PCS ≤ 25th percentile; n = 378) and non-physically impaired (PCS > 25th percentile; n = 1133). Work productivity (absenteeism, presenteeism and overall work impairment), activity impairment and healthcare resource utilization were compared between these groups. RESULTS Age, female sex, low and high body mass index (BMI), diabetes-related complications, cardiovascular events, unawareness of having hypoglycemic events in the past 3 months, and lack of regular exercise were significant factors associated with physical impairment in multivariable analysis. The physically impaired group reported significantly more regular outpatient visits (13.48 vs. 10.16, respectively, p

Purpose People with diabetes taking insulin are at risk of severe hypoglycemia, an unpredictable, life-threatening event that requires assistance from others. Outside the clinical setting, glucagon is indicated for the treatment of hypoglycemia. However, there is significant unmet medical need to improve successful administration of glucagon by caregivers and acquaintances. This study assesses perceptions about glucagon delivery and potential effects of 2 glucagon delivery devices for severe hypoglycemia. Methods Qualitative interviews were conducted with people with diabetes (patients), caregivers, and acquaintances from a general population panel composed of individuals across the United States who have agreed to be recruited for research studies. Participants were recruited via email with a link to an online screener to determine eligibility. Experienced qualitative researchers conducted telephone interviews after a semistructured discussion guide, developed by the authors, that focused on aspirational device features and perceptions about the 2 devices: nasal glucagon and autoinjector glucagon; visuals of the instructions for use were displayed. Verbatim transcripts were developed, and a qualitative analysis software program, MaxQDA, was used to code responses and themes that emerged from the data. Findings A total of 45 (15 patients, 15 caregivers, and 15 acquaintances) interviews were conducted (mean ages, 55, 40, and 51, respectively). The most frequently spontaneously identified aspirational features for a new glucagon device were ease of use (29 [64%]), including being uncomplicated, premixed/ready to use, and ability to use quickly; small/easy to carry (9 [20%]); needle-free/no long needles (8 [18%]); and easy instructions (4 [9%]). In general, participants indicated that having a glucagon delivery device on hand would make them feel prepared, protected, and confident that others could assist in the event of severe hypoglycemia. More participants across all subgroups preferred nasal glucagon versus autoinjector glucagon (33 [73%] vs 12 [27%]). Favorable comments about nasal glucagon included that it appeared to be easy to carry, easy to use, and lacked a needle, that one does not need to remove clothing to use it, and that others likely would be more comfortable using it. Favorable comments about autoinjector glucagon included that it was familiar as a rescue device and that patients felt confident that the full dose would be delivered with it. There may be more hesitation using autoinjector glucagon versus nasal glucagon because of anxiety about needles and locating an injection site. Participants indicated that they would feel more comfortable socially using nasal glucagon because it was viewed as more discreet and less embarrassing than using autoinjector glucagon; it was also considered less traumatic for use in children. Implications This research suggests that patients with diabetes, caregivers, and acquaintances prefer a device that is simple, compact, and ready to use. Nasal glucagon was generally preferred over autoinjector glucagon primarily because it lacks a needle and it appears to be less complicated.

449 Background: Immunotherapy and combination platinum chemotherapy are effective treatment options with different adverse events (AEs) for patients (pts) with metastatic urothelial carcinoma (mUC). This study quantified treatment preferences based on perceived benefit-risk trade-offs associated with first-line (1L) therapy among medical oncologists (MOs). Methods: MOs completed a cross-sectional online survey assessing treatment preferences for 3 pt groups: cisplatin (cis)-eligible (elig) PD-L1 high, cis-ineligible (inelig) PD-L1 high, and cis-inelig PD-L1 low. Three discrete choice experiments (DCEs) showed a series of tasks where MOs chose between 2 alternative treatment profiles varying on 7 attributes identified as important in qualitative research: overall survival (OS), overall response rate (ORR), all grades (G) neuropathy, G3/4 nausea/vomiting, colitis, pneumonitis, and neutropenia. Hierarchical Bayes models were used to estimate preference weights for each attribute. Results: A total of 210 MOs, averaging 16 years in practice (65% community [C], 35% academic [A]), participated. PD-L1 testing was available to most MOs, 87.5% (C) and 74.3% (A). In cis-elig PD-L1 high and cis-inelig -PD-L1 low pts, the order of relative importance was: OS, ORR, G3/4 nausea/vomiting, G3/4 neutropenia, G3/4 pneumonitis, all G neuropathy, and G3/4 colitis. In cis-inelig PD-L1 high pts, improved OS was most important but decreasing G3/4 nausea/vomiting was more important than improving ORR. In cis-elig PD-L1 high, cis-inelig PD-L1 high, and cis-inelig PD-L1 low pts, to accept increases in AEs, MOs require OS increases of 2.0, 3.0, and 2.5 months (G3/4 nausea/vomiting by 21%); 1.6, 1.8, and 2.0 months (G3/4 neutropenia by 23%); 0.9, 0.4, and 1.1 (G3/4 pneumonitis by 3%); and 0.9, 0.6, and 0.7 months (all G neuropathy by 5%), respectively. Conclusions: OS and ORR are key drivers for MOs in the choice of 1L therapy for pts with mUC. MO selection of therapy is governed by platinum eligibility, PD-L1 status, and a desire to limit AEs. Future 1L treatments for mUC pts need to provide a substantial OS benefit in exchange for a higher risk of AEs, especially in cis-inelig PD-L1 low pts, whom are perceived as having poor outcomes.

e18302 Background: Findings from few studies examining preferences for MM treatment are limited in application, as they are largely missing the voices of patients (PTs). The present qualitative study elucidates PT preferences, the perceived trade-offs they are willing to make, and how these may differ by line of therapy (LOT). Methods: Semi-structured phone interviews were conducted with MM PTs (front-line [FL] = 11, early relapse 1- 2 prior-lines [1/2PL] = 10) recruited via purposive sampling from targeted panels and PT groups, April-May 2018. A discussion guide was developed and a trained interviewer conducted 1-hour interviews on the diversity and valence of factors influencing how PTs evaluate potential regimens and how preferences vary by experience (i.e., LOT). Interviews were audio recorded and transcribed, responses coded, and content analysis performed to identify key themes emerging from textual data. Results: The sample was 42% male, mean age 64 years, with mean 58 months since diagnosis. Three key themes were identified. Firstly, treatment decision-making, revealed that trust in one’s health care provider (HCP) was a potent influence on treatment choice. Whereas FL PTs reported often only one option is offered and rely on HCP to make decisions, 1/2PL PTs consider other sources of information and engage in more shared decision-making. Secondly, expectations about treatment, illustrated that HCPs discuss important factors, e.g., efficacy and tolerability, in general terms with FL PTs and provide more details to 1/2PL PTs. Lastly, “ top of mind” factors that influenced treatment decisions, effectiveness, followed by side effects, emerged as the greatest influences on preference, although 1/2PL PTs reported less concern with side effects than FL PTs. Relatedly, quality of life was described as salient; the lived experience of treatment was often mentioned within the context of side effects. Conclusions: The way PTs construct, prioritize, and communicate about treatment when assessing “benefit-risk” is a dynamic process, based on where PTs are in their treatment journey. By examining treatment preferences grounded in PTs’ lived and changing experiences with MM, the findings may contribute to better PT-HCP engagement through treatment decision-making and improve clinical care.

Background: The growing importance of patient preferences in treatment decision-making in oncology is evidenced by the expanding role of patient-reported experience in both regulatory and reimbursement considerations of value. While recent introduction of new treatments for multiple myeloma (MM) have demonstrated longer time to progression and improved survival, specific regimen options still vary with respect to efficacy, safety, and dosing. Therefore, patients and providers must consider the trade-offs inherent in making treatment decisions. However, a lack of evidence exists describing patient reported preferences within the context of currently available regimens. To address this gap, this interim analysis of an ongoing study was conducted to examine patient preferences for MM treatments. Methods: A sequential mixed methods design, which incorporates both qualitative and quantitative phases, was utilized for this study. The qualitative phase identified content and language, via semi-structured interviews, to elucidate how patients understand and construct treatment-related factors, such as overall survival (OS), progression free survival (PFS), dosing, and tolerability. Results from the qualitative phase were subsequently used to inform the development of the quantitative survey. The online survey was sent to adults diagnosed with MM, who had received or were currently receiving first-line therapy (FL), second-line therapy (1PL), or third-line therapy (2PL) at the time of the survey (target N=200). Patients were recruited from targeted panels, advocacy partnerships, patient communities, and physician referrals from May to June 2018. The survey utilized a Discrete Choice Experiment (DCE) methodology to assess preferences and willingness to accept trade-offs among hypothetical treatments that varied on levels of specific attributes. Treatment attributes and levels were identified through literature review, current treatment guidelines, and clinical input. In the quantitative survey, patients were asked to rate the levels of each treatment attribute (based on a 5-point Likert scale, ranging from 1=very bad to 5=very good) and select which regimen they prefer when presented with two different hypothetical regimens (fixed choice exercise - Table 1) to identify trade-offs that patients were willing to make when selecting treatments. Descriptive statistics were used to characterize the interim survey data. Full DCE results, which will model additional treatment scenarios, will be based upon the complete sample. Results: In this interim analysis (n=74), the mean age was 63 years and 51% were male. The average time since diagnosis was 70 months. Twenty-five patients were on FL, 25 were on 1PL and 24 were on 2PL. Mean duration of most recent/current treatment at the time of survey completion was 16 months for FL, 15 months for 1PL, and 11 months for 2PL. On average, patients in earlier lines of therapy (FL and 1PL) indicated greater importance of OS than 2PL patients. The importance of tolerability was also greater for patients in earlier lines of therapy (FL and 1PL vs. 2PL). Results of the fixed choice exercise available at the time of this analysis are shown in Table 2. When efficacy (OS and PFS) were comparable, 92% of patients preferred the treatment profile with a lower dosing frequency over a 1 year period (21x) despite a longer infusion time (>5h) compared to a treatment profile with higher dosing frequency (78x) and shorter infusion time ( Conclusion: Results from this interim analysis suggest that patient preferences for MM treatments may vary by treatment history. Additionally, when efficacy is similar, a significant number of patients place greater importance on dosing frequency than on the duration of treatment administration. Patients may consider treatment options holistically - e.g., convenience is not simply "chair-time," but rather also includes frequency of outpatient visits. This study provides insight into how patients with MM value and assess meaningful "benefit-risk" when making treatment decisions, which can be useful for facilitating physician-patient communications and shared decision making. Analysis of the complete study population and DCE will provide additional results on the relative importance of specific treatment attributes and preference for hypothetical treatment regimens that were not available for this analysis. Disclosures McKay: Janssen Scientific Affairs,LLC: Employment. Maiese:Janssen Scientific Affairs,LLC: Employment, Equity Ownership. Chiarappa:Janssen: Employment. Cambron-Mellott:Kantar Health: Employment. Maculaitis:Kantar Health: Employment. Alunni:Kantar Health: Employment. Raje:BMS: Consultancy; Celgene: Consultancy; Janssen: Consultancy; Merck: Consultancy; Takeda: Consultancy; AstraZeneca: Research Funding; Research to Practice: Honoraria; Medscape: Honoraria; Amgen Inc.: Consultancy.