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Prevalence data on nocturnal polyuria (NP), nocturia caused by overproduction of urine during sleep, is primarily limited to men and varies by NP definition. This U.S.-representative epidemiological study of men and women ≥30 years old assessed the prevalence of NP.Consenting participants completed the baseline EpiNP (Epidemiology of Nocturnal Polyuria) survey (eg Lower Urinary Tract Symptoms Tool, comorbidities). All reporting ≥2 voids/night and a target of 100 random respondents reporting 0 or 1 void/night were asked to complete 3-day bladder diaries. NP was defined as nocturnal polyuria index (NPI)0.33 (NPI33) and nocturnal urine production90 ml/hour (NUP90). Extrapolated prevalence was stratified by sex and subgroups: idiopathic (without underlying causes), associated with overactive bladder (NPOAB), bladder outlet obstruction (NPBOO; men) and comorbidities. Voided volumes and timing, including first uninterrupted sleep period, were assessed by subgroup.A total of 10,190 individuals completed the baseline survey; mean age (range) was 54.4 (30-95). A total of 3,938 individuals were invited to complete the diary; 1,763 (49.3%) completed 3-day bladder diaries. Urine production (maximum nighttime volume, total volume, nocturnal urine production, nocturia index) was higher in both men and women with idiopathic NP and comorbidities. The median number of nighttime voids was greatest for NPBOO in men and NPOAB in women. Bother associated with nighttime voiding differed by NP subgroup but was highest in NPBOO for men (NPI33: 69.6%; NUP90: 71.1%) and NPOAB for women (NPI33: 67.5%; NUP90: 66.0%).This population-based NP prevalence study including men and women characterizes NP subgroups and provides insights into nocturia treatment by emphasizing factors influencing urine production versus factors influencing bladder capacity.

Individuals with sickle cell disease (SCD) experience vaso-occlusive crises (VOC). Historically, VOC episodes have been assessed through medical utilization, thereby excluding events managed at home. In order to validate a daily patient-reported outcome for patients with SCD to accurately report their VOC status and experience of a pain crisis, a SCD Diary was included in Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS), a longitudinal, six-month, non-interventional study. The daily patient-completed diary included a description of SCD pain crisis, followed by questions on: pain crisis in the past 24 h (VOC Day question; respective response yes or no), worst pain, tiredness, and functioning. Thirty-five patients with SCD participated in ELIPSIS. Analyses were performed to validate the patient-reported VOC Day. Mean symptoms and functioning scores on the first or last VOC Day of a VOC Event were compared using t-tests with the mean of the three non-VOC Days before and after the event. Mean severity of symptoms and functioning scores on all VOC Days compared to all non-VOC Days were higher, with statistically significant mean differences between first/last VOC Days and respective three non-VOC Days (p's .01). A subset of patients (n = 15) and caregivers (n = 9) were interviewed to evaluate their understanding of the SCD Diary questions. Nearly all confirmed that the pain crisis description accurately described the VOC experience, and participants expressed confidence differentiating SCD crisis pain from everyday pain. These results demonstrate patients can reliably report their experiences with VOC-related pain crises using the SCD Diary.

The Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) was developed to identify prescription opioid misuse and abuse among patients with chronic pain. A clinical scoring algorithm was developed and refined to align with the patient experience. This study utilized data from the POMAQ validation study (3033-4, NCT02660606) conducted on a sample of patients with chronic pain living in the United States. The study was carried out in two phases. Two purposefully enriched patient samples, one for each phase, were created based on patient responses to select POMAQ items and the availability of urine and hair samples. Two clinical experts (SHS, SFB) reviewed patient data to classify prescription opioid use behavior. Classification differences were adjudicated by a third clinical expert (JTF). Comparisons were made between the final clinical classification determined by the experts and the proposed classification based on the POMAQ algorithm. Sixty patients were included in Phase I (only POMAQ data) and 52 in Phase II (including POMAQ and ancillary sources [e.g. electronic medical records, urine toxicity screen]). Refinements were made to the POMAQ scoring algorithm following discussions with clinical experts to ensure it was clinically relevant. For both phases, classifications were reviewed and discussed to achieve maximal concordance of classifications across experts. The proposed scoring algorithm was then modified to maximize agreement with the expert interpretation of clinically relevant patient experiences. The clinical scoring algorithm for the POMAQ was developed and refined to reflect clinically relevant patient behaviors identified by expert review. Future testing is needed to determine the sensitivity and specificity of this measure.

To identify patient risk factors associated with prescription opioid misuse and abuse as well as groupings of misuse and abuse behaviors as measured by the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ). Adults with chronic pain requiring long-term treatment with opioids completed the POMAQ and other study questionnaires. Latent class analysis (LCA) was used to examine underlying subgroups exhibiting particular risk profiles. Patient demographic and clinical characteristics were examined as covariates and the concordance between the identified latent classes at-risk classifications and the POMAQ clinical scoring algorithm was assessed. Analysis of data from 809 patients revealed four classes: “chronic pain, low risk” (n = 473, low to no prevalence of POMAQ behaviors), “chronic pain, comorbid condition” (n = 152, high prevalence of anti-anxiety, sleeping pill, and antihistamine use), “at risk” (n = 154, taking more opioids than prescribed and drinking alcohol with opioids more frequently than other groups), and “high risk” (n = 30, highest prevalence of each behavior). The “high risk” group was associated with being younger, less educated, and unemployed compared to other groups. When examining the LCA classes by groups defined by the original POMAQ clinical scoring algorithm, the “high risk” class had the highest proportion of participants identified with abuse behaviors (46.7%), compared to just 4.7% in the “chronic pain, low risk” group. Findings suggest there are four distinct subgroups of patients defined by chronic opioid misuse and abuse behaviors and support the use of the POMAQ to identify risk factors associated with prescription opioid misuse and abuse.

Background Use of daily oral HIV pre-exposure prophylaxis (DO PrEP) has increased steadily in the past several years, but patterns of racial disparities have emerged in PrEP uptake. Although Black and Hispanic people are disproportionately affected by HIV in the US, they constitute a minority among those accessing DO PrEP. Newly available prevention options, such as long-acting injectable (LA) PrEP may help close the gap in unmet need for PrEP; however, interest in LA PrEP has not been evaluated specifically among racial/ethnic minority groups. Awareness, willingness, and usage of PrEP as well as HIV prevention preferences were assessed among sexually active adult men in the US. Methods Participants were recruited through a geographically targeted social media campaign and completed a self-administered, cross-sectional, online survey on demographics, sexual health and behavior, healthcare access, PrEP awareness and usage, and PrEP intention and preferences. Eligible participants met the following criteria: cisgender men, self-identified Black race and/or Hispanic ethnicity, 18 years or older, reporting unknown or HIV-negative status, currently residing in the US, and reporting anal or vaginal sex in the past six months. Descriptive statistics were calculated using SAS v9.4. Results From November to December 2021, 1365 men completed the survey (median age: 29.0 years; Black non-Hispanic: 43.1%, Black Hispanic: 40.3%, White Hispanic: 10.2%, Other Hispanic: 6.4%). A majority had heard of DO PrEP (66.6%) and LA PrEP (47.5%) as a way to prevent HIV; however, a smaller proportion had spoken to a healthcare provider (HCP) about PrEP (42.1%), had ever used PrEP (24.7%), or were currently taking PrEP (16.3%) (Figure 1). A large majority (74.0%) reported interest in using LA PrEP. When asked about their preferred PrEP option, 60.2% chose LA PrEP and 7.4% chose DO PrEP, while 27.5% stated that they preferred neither PrEP option. Figure 1.PrEP Awareness, Discussion with HCP, and Usage Among US Black and Hispanic Men, Overall and by Race/Ethnicity Conclusion Most participants demonstrated high awareness of PrEP and a strong interest in LA PrEP. The availability of and interest in LA PrEP may serve as an opportunity to help increase overall PrEP uptake among Black and Hispanic men in the US. Disclosures TONIA POTEAT, PhD, MPH, PA-C, ViiV Healthcare: Advisor/Consultant Supriya Sarkar, PhD, MPH, ViiV Healthcare: Salary|ViiV Healthcare: Stocks/Bonds Leigh Ragone, MS, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employment Keith Rawlings, MD, ViiV Healthcare: Employee Alex R. Rinehart, PhD, ViiV Healthcare: Stocks/Bonds Vani Vannappagari, MBBS, MPH, PhD, ViiV Healthcare: I am full time employee of ViiV Healthcare and receive GlaxoSmithKline stock as part of my compensation package|ViiV Healthcare: Stocks/Bonds.

Background Cisgender women continue to have low pre-exposure prophylaxis (PrEP) uptake in the US, despite making up almost 20% of new HIV infections. The gap between the number of women who would benefit from PrEP and those who use PrEP highlights the unmet need for HIV prevention in women. As new prevention options, such as long-acting (LA) injectable PrEP, become available, it is important to understand PrEP awareness and preferences among women to help meet this need. Awareness, willingness, and usage of PrEP as well as HIV prevention preferences were assessed among sexually active women in the US. Methods Cisgender women were recruited through a geolocation targeted social media campaign and completed a self-administered, cross-sectional, online survey on demographics, sexual health and behavior, healthcare access, PrEP awareness and history, and PrEP intention and preferences. Eligible participants were cisgender women, 18 years or older, who reported an unknown or HIV-negative status, currently resided in the US, and reported vaginal or anal sex in the past six months. Descriptive statistics were calculated using SAS v9.4. Results From November to December 2021, 961 participants completed the survey (median age: 28.0 years; Black non-Hispanic: 34.7%; Black Hispanic: 19.9%; White non-Hispanic: 21.3%; White Hispanic: 12.0%; Another race: 9.1%). A majority had heard of PrEP (70.6%) and LA PrEP (50.1%) as a way to prevent HIV; however, a smaller proportion had spoken to a healthcare provider (HCP) about PrEP (37.8%), had ever used PrEP (19.7%), or were currently on PrEP (9.3%). While PrEP awareness was high across all racial and ethnic groups, PrEP discussions with an HCP and PrEP usage was lowest among Black, non-Hispanic women (Figure 1). Most participants (78.8%) expressed intent to regularly use any HIV prevention method and 66.0% reported likelihood of using LA PrEP if it were available. Condoms were the most favored prevention option (46.7%) followed by HCP administered LA PrEP (24.3%), vaginal ring (9.0%), self-administered LA PrEP (8.8%), and oral PrEP (6.7%). Conclusion Although most women demonstrated high PrEP awareness and interest, many had never discussed PrEP with an HCP. The availability of LA PrEP may be an important opportunity for HCPs to discuss a preferred PrEP option with women. Disclosures Tonia Poteat, PhD, MPH, PAC, Merck & Co. Inc: Advisor/Consultant|Viiv Healthcare: Advisor/Consultant Supriya Sarkar, PhD, MPH, ViiV Healthcare: Salary|ViiV Healthcare: Stocks/Bonds Leigh Ragone, MS, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employment Keith Rawlings, MD, ViiV Healthcare: Employee Alex R. Rinehart, PhD, ViiV Healthcare: Stocks/Bonds Vani Vannappagari, MBBS, MPH, PhD, ViiV Healthcare: I am full time employee of ViiV Healthcare and receive GlaxoSmithKline stock as part of my compensation package|ViiV Healthcare: Stocks/Bonds.

A chronic pain patient sample living in the United States who participated in a cross-sectional study to evaluate the validity and reproducibility of the Prescription Opioid Misuse and Abuse Questionnaire is characterized.Patients with chronic pain identified through electronic medical records as refilling at least one opioid prescription within the prior 3 months were recruited from five United States Department of Defense Military Health System clinics. Patients completed the Prescription Opioid Misuse and Abuse Questionnaire, Brief Pain Inventory-Short Form, Medical Outcomes Study: 36-item Short Form, and sociodemographic questions online. Clinical characteristics and electronic medical records for 1 year prior to consent were collected.809 (86.2%) participants completed the Prescription Opioid Misuse and Abuse Questionnaire. Mean (± standard deviation) age was 55.4 ± 12.7 years; the majority female (55.5%) and white (74.8%). Mean duration of chronic pain was 14.7 ± 10.5 years; the most common pain conditions were lower back pain (76.6%), neck or shoulder pain (60.3%), and osteoarthritis (38.7%). The most commonly prescribed opioids were oxycodone (35.7%), tramadol (34.5%), and hydrocodone (26.9%); 54.8% took one opioid, 44.9% took 2 or more opioids.Participants' health status was poor; pain severity and interference were moderate. Electronic medical record data revealed high healthcare resource utilization. This chronic pain population was severely impacted by their pain condition(s).

The Prescription Opioid Misuse and Abuse Questionnaire was developed to identify prescription opioid abuse and misuse among patients with chronic pain, however evidence of construct validity and reproducibility is needed. Chronic pain patients were recruited from five Department of Defense Military Health System clinics across the United States. Construct validity was examined using subjective clinician-reported and patient-reported measures as well as objective information (e.g., hair/urine drug screens and electronic medical records). Test-retest reliability was assessed across 2-time points among a subgroup of patients with stable chronic pain. Of 3,263 screened patients, 938 (28.7%) met eligibility and were enrolled; 809 (86.2%) completed the Prescription Opioid Misuse and Abuse Questionnaire. Construct validity was supported by comparison to other validated questionnaires and hair and urine screens which yielded high agreements with patient reports on the Prescription Opioid Misuse and Abuse Questionnaire. Electronic medical record data supported patients’ Prescription Opioid Misuse and Abuse Questionnaire responses regarding physician and emergency room visits and opioid refills. The Prescription Opioid Misuse and Abuse Questionnaire had excellent test-retest reliability; the percentage agreement between the two Prescription Opioid Misuse and Abuse Questionnaire administrations was high (>90%) for most questions. Results suggest that the Prescription Opioid Misuse and Abuse Questionnaire is a valid and reproducible tool that can be used to assess the presence of prescription opioid misuse and abuse among patients with chronic pain.

Content validation is essential in the development of patient-reported instruments to ensure relevancy and understandability. The aim was to evaluate patient understanding of the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) using cognitive interviewing among adults with chronic moderate to severe pain.This qualitative study involved a one-time in-clinic visit to conduct one-on-one cognitive interviews among participants with chronic moderate to severe pain from four groups: (1) Known Opioid Abuse; (2) Known Abuse of Other Substances (e.g. alcohol, benzodiazepines); (3) Opioid Non-abuse; and (4) No Chronic Opioid Use. Patients were recruited from 6 US clinical centers. Concept elicitation questions regarding misuse and abuse were asked at interview start; the POMAQ was completed56 patients were enrolled. Mean age was 48.7 ± 12.3 years; 57% female; 80% Caucasian; mean duration of chronic pain was 11.2 ± 8.2 years with lower back pain predominating at 75%. Overall, the POMAQ was well-understood and received positive feedback. A few (The POMAQ demonstrated content validity among patients with moderate to severe chronic pain and is undergoing psychometric evaluation among a larger cohort of patients.

Introduction The Diabetes Injection Device Preference Questionnaire (DID-PQ) was designed to assess patient preference between two non-insulin injection devices. In a recent crossover study, people with type 2 diabetes (T2D) completed the DID-PQ after performing mock injections with two non-insulin injection devices. The purpose of the current analysis was to use these data to assess construct validity of the DID-PQ and demonstrate one way to test whether there is a significant preference for one injection device over another. Methods Data were from an open-label, multicenter, randomized, crossover study assessing preference between the dulaglutide and semaglutide injection pens. In addition to the 10-item DID-PQ, people with T2D completed a global item assessing overall preference. DID-PQ responses were compared to the global preference item (percent agreement, Gwet’s AC1, prevalence-adjusted and bias-adjusted Kappa [PABAK]). For each item of the DID-PQ, a two-sided binomial test assessed whether the difference in preference was statistically significant. Results The sample included 310 participants (48.4% female; mean age = 60.0). The DID-PQ had minimal missing data. There was strong concordance (percent agreement > 78%) between the global preference item and all DID-PQ items except item 6, which assesses preference related to needle size (59.7%). The Gwet AC1 and PABAK statistics also indicated strong agreement between the global preference item and all DID-PQ items except item 6. There was a statistically significant difference (p Discussion Patient preference has been recommended as a “major factor driving the choice of medication” in a consensus report by the American Diabetes Association and the European Association for the Study of Diabetes. Current findings suggest that the DID-PQ may be a useful tool for providing insight into preferences of people with T2D using non-insulin injectable medication.

Elagolix treatment for moderate to severe endometriosis-associated pain results in dose-dependent, clinically meaningful improvements in health-related quality of life., OBJECTIVE: To evaluate the effects of elagolix on clinically meaningful improvements in health-related quality of life (HRQOL) measured by the EHP-30 (Endometriosis Health Profile-30). METHODS: Data from two phase III trials of elagolix for moderate to severe pain associated with endometriosis were pooled and analyzed as three groups: placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily. Patients were administered the EHP-30 questionnaire at baseline, and at months 1, 3, and 6 of treatment. Previously established responder definitions were applied to determine percentages of patients with clinically meaningful EHP-30 improvements. The probability of meeting EHP-30 responder definitions with elagolix compared with placebo at months 3 and 6 was determined by Poisson regression analysis, controlling for baseline scores. RESULTS: At month 6, the probabilities of meeting EHP-30 subscale responder definitions for pain, control and powerlessness, self-image, social support, emotional well-being, and sexual intercourse were 169% (adjusted relative risk [aRR]: 2.69, 95% CI 2.26–3.21), 129% (aRR 2.29, 95% CI 1.96–2.67), 80% (aRR 1.80, 95% CI 1.54–2.11), 70% (aRR 1.70, 95% CI 1.47–1.97), 67% (aRR 1.67, 95% CI 1.45–1.92), and 62% (aRR 1.62, 95% CI 1.36–1.92) greater, respectively (all P

The prevalence of nocturnal polyuria (NP), which is passing large volumes of urine during the main sleep period, has been investigated primarily in middle-aged to older men. There is thus a gap in the NP evidence base for women and for younger individuals.To estimate the prevalence of nocturia due to NP in the USA.This large epidemiologic study used a US population-representative sample of men and women aged ≥30 yr to assess the prevalence of NP (NCT04125186).Consenting participants completed an online survey (Lower Urinary Tract Symptoms Tool and comorbidities). All who reported two or more voids per night and 100 random respondents each reporting no or one void per night were asked to complete a 3-d bladder diary. Two NP definitions were used: nocturnal urine production90 ml/h (NUP90) and Nocturnal Polyuria Index0.33 (NPI33). Crude and population-adjusted prevalence results were calculated from completed diaries for the following subgroups by sex and age: idiopathic NP; NP with overactive bladder (NP-OAB) or bladder outlet obstruction (NP-BOO; men only); NP associated with other comorbidities; and no NP (did not meet the NPI33 or NUP90 definition).Among the 10,190 respondents who completed the survey, the mean age was 54.4 yr (range 30-95); 3,339 reported two or more nocturnal voids and 1,763 completed the 3-d diary (response rate 49.3%). The adjusted overall NP prevalence was 31.5% among men and 38.5% among women using the NPI33 definition, and 23.8% among men and 18.1% among women using NUP90. The adjusted idiopathic NP prevalence was lower among men (NPI33: 5.2%; NUP90: 1.4%) than among women (NPI33: 9.8%; NUP90: 4.0%). The prevalence of idiopathic NP decreased with age as NP associated with other possible causes increased with age in men (most common, BOO) and women (most common, OAB).This is the first population-based study of NP prevalence to include men, women, and young adults. NP is common; a multifactorial etiology should be considered, particularly as age increases.In this population-based US study, we examined the frequency of nighttime urination among men and women aged ≥30 y and older. We found that nighttime urination is common among men and women. Many conditions can lead to increased nighttime urination as people age.

Aim When selecting treatments for type 2 diabetes (T2D), it is important to consider not only efficacy and safety, but also other treatment attributes that have an impact on patient preference. The objective of this study was to examine preference between injection devices used for two weekly GLP‐1 receptor agonists. Materials and Methods The PREFER study was an open‐label, multicentre, randomized, crossover study assessing patient preference for dulaglutide and semaglutide injection devices among injection‐naïve patients receiving oral medication for type 2 diabetes. After being trained to use each device, participants performed all steps of injection preparation and administered mock injections into an injection pad. Time‐to‐train (TTT) for each device was assessed in a subset. Results There were 310 evaluable participants (48.4% female; mean age, 60.0 years; 78 participants in the TTT subgroup). More participants preferred the dulaglutide device than the semaglutide device (84.2% vs. 12.3%; P

Objective: Endometriosis impacts health-related quality of life. The objective was to assess the validity and responsiveness of the Health-Related Productivity Questionnaire, version 2 (HRPQ). Methods: Outcome measures (Endometriosis Health Profile-30; pain scales; and global assessment) from Elaris Endometriosis I and II clinical trials (EM-I, EM-II) were used. Validity testing using Cohen's conventions was assessed. Known-groups validity was evaluated using generalized linear models comparing clinical responders, assessment of change, and the endometriosis impact. The effect size (ES) and standard error of means were calculated to evaluate responsiveness. Results: 871 and 815 women participated in the EM-I and EM-II trials. The total hours of lost work among employed women were 16.5 (±11.4) hours per week for EM-I and 15.2 (±11.3) for EM-II. The total hours of lost work among the household group were 8.3 (±8.7) hours for EM-I and 8.4 (±9.0) hours for EM-II. HRPQ discriminated between all known group assessments tested. Correlations for the HRPQ compared to other measures were small to moderate. Moderate to large ES was observed and the ability of the HRPQ to detect change was strong using patient-reported impressions. Conclusion: The HRPQ is a valid and responsive tool for evaluating patient-reported productivity at work and at home among women with endometriosis.

The Asthma Impairment and Risk Questionnaire (AIRQ) is a 10-item, equally weighted, yes/no control tool validated in patients with asthma aged 12 years and older.To evaluate AIRQ's ability to predict patient-reported exacerbations over 12 months.Patients completed a baseline AIRQ during an in-person enrollment visit and reported exacerbations (ie, asthma-related courses of oral corticosteroids, emergency department/urgent care visits, and hospitalizations) via monthly online surveys. Logistic regressions were performed using AIRQ control level (well-controlled [WC], not well-controlled [NWC], very poorly controlled [VPC]), age, sex, race, and body mass index as covariates and 1 or more and 2 or more exacerbations as the dependent variables (adjusted odds ratios [OR] and 95% Wald CIs). Kaplan-Meier analyses of time to first exacerbation by AIRQ control level were performed.A total of 1,112 patients were enrolled; 1,070 completed 1 or more surveys over 12 months (mean ± SD 10.5 ± 2.8 months); 70.5% female; age 43.9 ± 19.3 years; 20.4% non-White; body mass index 30.6 ± 8.7 kg/mThe AIRQ control level predicts exacerbation risk over 12 months and probability of time to first exacerbation.

Background: Patients and healthcare providers overestimate asthma control. Aim: To evaluate US asthma patients’ and their specialty physicians’ subjective assessment of control compared to the symptom-based Asthma Control Test (ACT™) and composite Asthma Impairment and Risk Questionnaire (AIRQ™). Methods: 1113 specialist-treated patients of all severity levels aged ≥12 yrs were enrolled in a validation study of AIRQ™. AIRQ™ is a 10-item, equally weighted, yes/no tool assessing symptom impairment and risk of exacerbations with score ranges indicating well-, not well-, or very poorly controlled asthma. At entry, ACT™ and AIRQ™ were given during a comprehensive visit, and prior-year, chart-documented, severe exacerbations recorded. Patients and physicians rated control on a 5-item Likert scale (completely, well, somewhat, poorly, not controlled). Results: Mean(SD) age 44(20) yrs; 15% 12-17 yrs; 30% male, 78% white. Physicians rated 54% of patients as completely/well-controlled; 62% of evaluable patients rated themselves similarly. 49% were well-controlled per ACT™ (score ≥20) and 35% per AIRQ™ (0 or 1 yes responses). 30% of physician-rated completely/well-controlled patients and 33% of similarly self-assessed patients had ≥1 prior-year exacerbation. 30% of patients well-controlled per ACT™ and 15% per AIRQ™ had prior-year exacerbations. Thus, for patients whose scores indicated well-controlled asthma, 85% of AIRQ™ vs only 70% of ACT™ assessments correctly identified exacerbation risk. Conclusion: AIRQ™ includes impairment and risk items and provides a more comprehensive assessment of asthma control than patient and physician ratings or symptom-based tools.

Background: Pruritus is a prevalent and bothersome symptom of scalp psoriasis. Validated scales assessing scalp itch are needed to evaluate treatment efficacy.Objective: To evaluate comprehensibili...

Objective To evaluate the utility, responsiveness, and thresholds for clinically meaningful change of a numerical rating scale for worst pain associated with dysmenorrhea (NRS-DYS) and nonmenstrual pelvic pain (NRS-NMPP) in women with moderate to severe endometriosis-associated pain. Design Analysis of data from two phase III randomized clinical trials (EM-I [NCT01620528] and EM-II [NCT01931670]). Setting Not applicable. Patient(s) Premenopausal women ages 18–49 years with moderate to severe endometriosis-associated pain. Intervention(s) Participants in both trials were randomized 3:2:2 to receive placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily for 6 months. Main Outcome Measure(s) NRS-DYS and NRS-NMPP. Result(s) EM-I enrolled 871 women and EM-II enrolled 815 women. For patients with a global impression of improvement at month 3, the least-squares mean change between baseline and month 3 was −3.6 (EM-I and EM-II) for NRS-DYS and −1.9 (EM-I) and −2.0 (EM-II) for NRS-NMPP. Standard errors of measurement were 2.99 (EM-I) and 2.86 (EM-II) for NRS-DYS and 1.74 (EM-I) and 1.71 (EM-II) for NRS-NMPP. Baseline half standard deviations were 0.78 (EM-I) and 0.85 (EM-II) for NRS-DYS and 0.92 (EM-I) and 0.96 (EM-II) for NRS-NMPP. Based on these results, clinically meaningful changes were defined as a reduction of 4 points for NRS-DYS and 2 points for NRS-NMPP. Conclusion(s) This study demonstrated the utility and responsiveness of separate numerical rating scales to assess worst pain for dysmenorrhea and NMPP in women with moderate to severe endometriosis-associated pain and identified initial thresholds for clinically meaningful change.

Background Dyspareunia experienced by women diagnosed with endometriosis is associated with a decreased health-related quality of life (HRQoL). Aim We evaluated the relationship of clinically meaningful improvements in dyspareunia with HRQoL changes among women with endometriosis. Methods This was a post hoc analysis of pooled data from the phase III ELARIS-I and ELARIS-II clinical trials. Women aged 18–49 years with moderate to severe endometriosis-associated pain were randomized to placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily. HRQoL was measured using the validated Endometriosis Health Profile-30 questionnaire (EHP-30), consisting of 5 core domains and a sexual intercourse modular domain. Dyspareunia was ranked 0–3 (none, mild, moderate, or severe) or not applicable using a daily eDiary and averaged monthly. A woman with a clinically meaningful dyspareunia response (dyspareunia responder) was defined as a woman with a reduction from the baseline in dyspareunia score greater than or equal to a predetermined cutoff while maintaining stable/decreased analgesic use. Outcomes Dyspareunia response impact on EHP-30 scores was determined at 3 and 6 months using multivariate linear regression controlling for age, baseline EHP-30 scores, and dysmenorrhea and non-menstrual pelvic pain symptom severity. Results Analysis included 1,368 women with a mean age of 32.2 years. Dyspareunia responders had significant improvements vs non-responders in all adjusted mean EHP-30 domain scores at months 3 and 6 (control and powerlessness: −17.8 and −18.5; emotional well-being: −10.0 and −10.4; pain: −15.3 and −15.7; self-image: −11.4 and −12.8; social support: −14.3 and −14.0; and sexual intercourse: −18.1 and −19.7; all P Clinical Implications Dyspareunia improvements are associated with both personal and psychological benefits. Strengths & Limitations This study involved a large sample of women from a well-defined patient population to provide statistical power in evaluating the results. As such, the findings may not be generalizable in a real-world setting. Although the perception of dyspareunia and its severity and the associated effect on HRQoL was subjective, the use of a large patient sample was used to minimize potential issues with this limitation. Conclusion Clinically meaningful responses in dyspareunia are associated with improvements across multiple HRQoL domains among women with endometriosis.

Objective The purpose of this analysis was to evaluate the experience of opioid-induced constipation in younger patients and identify differences in the experience of opioid-induced constipation and its symptoms between younger patients (

To evaluate the impact of uterine fibroid symptoms on employment and household productivity.An online survey of US women between 18 and 54 was conducted. Productivity was assessed using the health related productivity questionnaire (HRPQ). Descriptive statistics and logistic multivariable regressions examined the relationship between uterine fibroids (UF) symptom experience and employment and household productivity.Of 1365 eligible women, 873 (64.0%) were employed. Women lost an average of 0.8 hours to employment-related absenteeism and 4.4 hours due to employment-related presenteeism for 5.1 hours of employment productivity lost/week. Women lost an average of 1.4 hours due to household-related absenteeism and 1.6 hours due to household-related presenteeism for a total of 3.0 hours of household lost productivity. Productivity losses increased with increases in symptom burden.UF has a substantial impact on employment-related and household-related productivity.

Objective: To evaluate the responsiveness of the Endometriosis Health Profile-30 (EHP-30) and ascertain score changes that are indicative of response to treatment. A post hoc analysis of two Phase ...

Endometriosis-related pain symptoms have a negative impact on health-related quality of life and productivity. In fact, as endometriosis-related symptom severity and the number of symptoms experienced increases, health-related quality of life decreases. Dysmenorrhea and nonmenstrual pelvic pain are prominent symptoms experienced by women with endometriosis and were shown to have improved with the oral, nonpeptide gonadotropin-releasing hormone antagonist, elagolix.The objective of this post hoc analysis was to address the question of if patients show a clinical response (in dysmenorrhea or nonmenstrual pelvic pain), do they also have improvements in health-related quality of life and in productivity?This post hoc analysis used data from the Elaris Endometriosis-I and Elaris Endometriosis-II phase III, randomized, placebo-controlled studies. A surgical diagnosis of endometriosis (in the past 10 years), premenopausal, aged 18-49 years, and moderate to severe endometriosis-associated pain were among the inclusion criteria for both trials. Women self-reported pain daily using a scale ranging from 0 (no pain) to 3 (severe pain); daily pain was assigned to either dysmenorrhea or nonmenstrual pelvic pain based on self-reported bleeding on that particular day. In addition, their self-reported endometriosis-associated pain must have been an average of moderate or severe during the month leading to baseline for inclusion in the trial program. Patients were characterized as achieving a clinical response for dysmenorrhea or nonmenstrual pelvic pain (ie, responder or nonresponder), which was defined as women who did not have an increase in analgesic use and who met the pain reduction score threshold at month 3. Pain reduction score thresholds were defined separately for dysmenorrhea and nonmenstrual pelvic pain in the trial using receiver-operating characteristics analysis. Health-related quality of life was assessed using the Endometriosis Health Profile-30; work productivity was assessed using the Health-Related Productivity Questionnaire.Women enrolled in Elaris Endometriosis-I (n = 871) and Elaris Endometriosis-II (n = 815) were included in this analysis. Patients with a clinical response during treatment to dysmenorrhea or nonmenstrual pelvic pain also experienced a meaningful improvement in all domains of the Endometriosis Health Profile-30 at month 3. Patients who did not show a dysmenorrhea or nonmenstrual pelvic pain clinical response at month 3 did not exhibit mean improvements in Endometriosis Health Profile-30 domain scores that indicate an Endometriosis Health Profile-30 responder. Productivity improved among dysmenorrhea clinical responders. In the Elaris Endometriosis-I study, clinical responders lost a total of 5.9 hours compared with a total of 13.0 hours for nonresponders of employment-related work at month 3 (P.0001). Among women in the Elaris Endometriosis-II study, a total of 4.1 hours and 10.4 employment-related hours were lost at month 3 for dysmenorrhea responders vs nonresponders (P.001). Similar results were obtained when analyzed by non-enstrual pelvic pain responder status.Women with moderate to severe endometriosis-related pain, who are clinical responders based on dysmenorrhea and nonmenstrual pelvic pain, also experience significant and clinically meaningful improvement in health-related quality of life and productivity as measured by the Endometriosis Health Profile-30 and Health-Related Productivity Questionnaire, respectively.

Purpose Opioid-induced constipation (OIC) is a bothersome side effect of opioid use for the management of noncancer pain, affecting patients’ health-related quality of life and chronic-pain management. The objective of this study was to examine the relationship between changes in the frequency of spontaneous bowel movements (SBMs) and changes in patient-reported outcomes (PROs) among patients with OIC treated with naloxegol. Methods Post hoc analyses were conducted using pooled data from two Phase III 12-week, placebo-controlled trials of naloxegol for the treatment of OIC (NCT01309841 and NCT01323790). Patients completed the Patient Assessment of Constipation–Quality of Life (PAC-QOL) and PAC–Symptoms (PAC-SYM) at each study visit, and the Straining Scale and Bristol Stool Scale (BSS) with each bowel movement for the study duration. Four subgroups were created based on improvements from baseline in mean frequency of SBMs per week: 0 or worse (no change), +1 SBM, +2 SBMs, and +≥3 SBMs. Spearman correlations assessed the association between mean SBM changes from baseline and mean changes from baseline in PROs; analysis of covariance was used to compare changes from baseline. Findings A total of 1337 patients with mean (SD) age of 52.2 (11.0) years were included in this analysis. The patient population was predominantly white (79.0%) and female (62.4%). At baseline, mean SBM frequency was 1.4 (1.0) per week. At study end, all 4 SBM-change subgroups experienced improvements in PAC-QOL, PAC-SYM, Straining Scale, and BSS scores, and these changes were significantly correlated with mean changes from baseline in SBMs per week. The subgroup of patients with an increase in SBMs of ≥3 per week experienced the greatest improvements in PROs. Implications In these patients with OIC, an improvement in the frequency of SBMs by ≥3 per week was associated with consistent improvements in PROs, providing support for the use of improvements in SBMs as a clinical outcome surrogate for managing patients with OIC. Further research is needed to determine a threshold for change in SBMs that is clinically meaningful in both research and clinical settings. A key limitation was the post hoc nature of the study, which was not powered prospectively to examine these relationships.

The Chronic Pain Questions (CPQ) were developed for clinical use with the aim of supporting primary care physicians in the screening, assessment and monitoring of patients with chronic pain. the purpose of this study was to examine the ability of the cpq CPQ to discriminate between patients with neuropathic pain (nep) versus those with sensory hypersensitivity (sh).Adult men and women with a diagnosis of a NeP or SH condition were recruited from 5 clinical sites across the United States. Participants completed a series of self-administered questionnaires, including the CPQ. Continuous variables were compared between groups with independent t-tests; categorical variables were compared with chi-square analyses. A series of exploratory logistic regressions were performed to discern optimal screening criteria for SH using CPQ responses.98 participants, 68 with physician-confirmed diagnoses of SH and 30 with NeP, participated. 81.6% were female, 73.5% Caucasian, and mean (± SD) age was 58.4 ± 12.6 years. SH participants included significantly more females compared to the NeP group (94.1% vs. 53.3%). Differences in CPQ responses between groups were statistically significant for six of the 14 CPQ items with SH participants having significantly lower scores on specific pain quality questions and significantly higher scores on trouble thinking/remembering (5.3 ± 3.5 vs. 3.0 ± 2.8) and sensitivity to lights/noises/smells (4.8 ± 3.5 vs. 2.7 ± 3.0). No significant differences were found between groups for chronic pain intensity, pain made worse with touch, pain limited to joints, or pain interference with usual activity, sleep or mood. Logistic regression analyses revealed strong c indices (≥0.89) for all models. Consistent findings demonstrated that younger age, female gender, and scores ≥6 for the CPQ question on sensitivity to lights/noises/smells were all predictive of SH.The CPQ can help differentiate between patients with NeP and SH. More research is warranted.

Collecting data that helps evaluate different types of pain may improve physicians' decision-making with regard to treatment selection and on-going monitoring of patients. To date, no chronic pain assessments have been widely implemented in primary care. The aim of this study was to psychometrically validate the electronic Chronic Pain Questions (eCPQ) in a primary care setting.All men and women ≥18 years arriving at two similar primary care clinics in southeastern Michigan were invited to participate. Clinic staff verbally administered the eCPQ to patients and recorded their answers into the electronic medical record (EMR) prior to physician consultation with results available for physician review. Concurrent validity was assessed using Spearman correlations between eCPQ and patient-completed ancillary measures. Known-group validity was assessed by stratifying patients on self-reported chronic pain as well as by pain diagnosis (i.e. ICD-9 codes). To compare patients with chronic pain versus no chronic pain t-tests and chi-square tests were performed. Reproducibility was assessed between interviewer- and self-administration over time.A total of 534 patients were invited to participate and 455 patients consented to take part in the study (85.2% response rate); 395 patients had analyzable eCPQ data; 70.1% were Caucasian; 68.1% female; mean age was 43.4; 52.7% (n = 208) self-reported chronic pain. Correlations between eCPQ and ancillary measures supported concurrent validity. Excellent discrimination between groups was evidenced based on self-reported chronic pain and ICD-9 diagnosis. Patients with self-reported chronic pain reported significantly (p .0001) higher pain ratings and greater interference with usual activities, sleep, and mood than those without chronic pain. Test-retest reliability between modes (interviewer- vs. self-administration) was excellent as was reproducibility based on self-administration of the eCPQ at two separate time points. Key limitations: Discriminant validity was determined by comparing participants based on ICD codes. Utilizing ICD codes to identify individuals with chronic pain may not be a reliable approach as it is dependent upon providers accurately and consistently entering chronic pain diagnoses in the EMR.The eCPQ has sound psychometric measurement properties, including concurrent validity, discriminant validity, and reproducibility. The eCPQ appears to be useful to identify patients with chronic pain and to assess and monitor symptoms over time.

The objectives of this study are to describe the implementation process of the Women’s Health Assessment Tool/Clinical Decision Support toolkit and summarize patients’ and clinicians’ perceptions of the toolkit. The Women’s Health Assessment Tool/Clinical Decision Support toolkit was piloted at three clinical sites over a 4-month period in Washington State to evaluate health outcomes among mid-life women. The implementation involved a multistep process and engagement of multiple stakeholders over 18 months. Two-thirds of patients (n = 76/110) and clinicians (n = 8/12) participating in pilot completed feedback surveys; five clinicians participated in qualitative interviews. Most patients felt more prepared for their annual visit (69.7%) and that quality of care improved (68.4%) while clinicians reported streamlined patient visits and improved communication with patients. The Women’s Health Assessment Tool/Clinical Decision Support toolkit offers a unique approach to introduce and address some of the key health issues that affect mid-life women.

Aim: To evaluate outcomes after implementing the women's health assessment tool (WHAT) and clinical decision support toolkit during annual well-women visits. Methods: An observational project involved women aged 45–64 years attending one of three medical sites in Washington (WA, USA). Responses to the WHAT questionnaire and patients' health resource utilization prepost toolkit implementation were analyzed. Results: A total of 110 women completed the WHAT questionnaire. Majority of women were postmenopausal (77.3%) and experienced depressive mood (63.6%), hot flashes (61.8%) or anxiety (60.9%) in the last 3 months. There was a 72.2% increase in the number of diagnoses made during the annual visit versus the previous 12 months. Conclusion: The WHAT/clinical decision support toolkit helped identify conditions relevant to mid-life women.

Introduction: Individuals with sickle cell disease (SCD) experience vaso-occlusive crises (VOCs) - acute episodes of severe pain caused by vaso-occlusion. Vaso-occlusion typically causes complications, including ischemic damage to tissues resulting organ failure (Piel 2017). Historically, VOC events were assessed only through medical utilization, thereby excluding events managed by patients strictly at home. Thus, many VOC events are never recorded in the medical system, and the treatment benefit of new SCD therapies may be underestimated when relying on medical utilization alone. Objective: The goal was to develop and validate a daily diary for patients with SCD to accurately report their VOC status. Methods: A pilot patient diary was developed from qualitative interviews with patients with SCD and their caregivers and implemented as an electronic daily diary (eDiary) in a longitudinal, 6-month, non-interventional Phase 0 study of pain biomarkers in adolescents and adults (ELIPSIS Study; Callaghan et al 2017). The eDiary included a description of SCD pain crisis, which was followed by questions on: 1) pain crisis in the past 24 hours (ie, VOC Day question); 2) worst pain; 3) tiredness; and, 4) ability to perform usual physical activities. If a patient responded "yes" to the VOC Day question, they were asked how they treated their pain (eg, emergency room, hospitalized, called or visited doctor, treated self at home). Interviews were conducted among patients and caregivers in ELIPSIS to evaluate their understanding of the eDiary. All face-to-face interviews followed a semi-structured interview guide, were audio-recorded, and transcribed. Qualitative interview data were analyzed using content analysis. Quantitative analyses were conducted using the ELIPSIS data. A VOC Day was recorded when a patient responded "yes" to the VOC Day question. A VOC event was a sequence of VOC Days that could also include single intervening days with no reported pain crisis. Each VOC event was classified by the highest level of treatment received during the event. Psychometric analysis of the ELIPSIS data was performed to validate the VOC Day concept. Mean symptoms and activities scores on the first or last VOC Day of an event were compared using t-tests with the mean of the 3 non-VOC days: 1) prior to the first reported VOC Day of an event, or 2) following the event to examine each score's sensitivity to change in patient VOC status. Results: Thirty-five patients with SCD (mean [± SD] age 24.7 [± 9.5] years) participated in ELIPSIS; 51.4% were female. A majority (62.3%) of VOC events in ELIPSIS were treated at home, while 18.4% culminated in a hospitalization, 17.5% resulted in direct healthcare utilization, and the remaining patients (1.8%) had indirect healthcare utilization. Thirty-one patients reported ≥ 1 VOC Day. The mean number of VOC Days per patient was 11.2 ± 19.3 (1.0-91.0), and mean duration of VOC events was 2.7 ± 3.3 days (1.0-14.7). Mean severity of symptoms and activities scores on all VOC Days compared to all non-VOC Days were higher (worst pain: 7.6 vs. 2.6; tiredness: 6.3 vs. 4.1; usual physical activities: 3.6 vs. 2.6), with significant mean differences between first/last VOC Days and respective 3 non-VOC Days (all p Fifteen SCD patients and 9 caregivers completed an interview following ELIPSIS. Nearly all (93% of patients; 89% of caregivers) confirmed that the eDiary definition of pain crisis accurately described the experience of a SCD pain crisis, and participants expressed confidence in differentiating SCD crisis pain from everyday pain. Conclusions: These results demonstrate that patients can reliably report their experiences with VOC-related pain crises on an eDiary by responding to the VOC Day question. Qualitative data demonstrated that ELIPSIS patients: 1) differentiated between everyday pain and SCD crisis pain, and 2) endorsed the SCD pain crisis description included in the eDiary. The high proportion of patient-reported VOC events treated at home indicates that relying on operational VOC definitions requiring medical utilization results in a substantial number of missed VOC events. By broadening the VOC definition to include patient-reported, non-medical utilization VOC events, future studies can evaluate the impact of new therapies and their efficacy in reducing VOC events. The daily VOC Day question is a critical tool for capturing the VOC experience of patients with SCD. Disclosures Coyne: Evidera: Current Employment; Pfizer: Consultancy. Currie:Evidera: Current Employment; Pfizer: Consultancy. Callaghan:Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Site Investigator/sub-I Clinical Trial, Research Funding; Alnylum: Current equity holder in publicly-traded company; Bioverativ: Membership on an entity's Board of Directors or advisory committees; Octapharma: Honoraria, Membership on an entity's Board of Directors or advisory committees; Biomarin: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Site Investigator/sub-I Clinical Trial, Speakers Bureau; Sancillio: Other; Hema Biologics: Honoraria, Membership on an entity's Board of Directors or advisory committees; NovoNordisk: Other, Speakers Bureau; Bayer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Global Blood Therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other, Speakers Bureau; Grifols: Honoraria, Membership on an entity's Board of Directors or advisory committees; Spark: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche/Genentech: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Site Investigator/sub-I Clinical Trial, Speakers Bureau; Shire: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Wyrwich:Pfizer: Current Employment, Current equity holder in publicly-traded company. Pease:Pfizer: Current Employment, Current equity holder in publicly-traded company. Baker:Pfizer: Current Employment, Current equity holder in publicly-traded company. Arkin:Pfizer: Current Employment, Current equity holder in publicly-traded company, Other: own stock/options in the company. Pittman:Pfizer: Current Employment, Current equity holder in publicly-traded company.

Background Asthma exacerbation risk increases with worsening asthma control. Prevailing numerical control tools evaluate only current symptom impairment despite the importance of also assessing risk based on exacerbation history. An easy-to-use questionnaire addressing impairment and risk domains of control is needed. Objective To validate a composite asthma control tool that includes impairment and risk assessments (Asthma Impairment and Risk Questionnaire [AIRQ]). Methods Four-hundred forty-two patients aged ≥12 years with physician-diagnosed asthma who were followed in specialty practices completed 15 impairment and risk questions with dichotomized yes/no responses. Patients spanned all Global Initiative for Asthma severities and were classified as well-controlled, not well-controlled, or very poorly controlled according to a standard of Asthma Control Test (ACT) score plus prior-year exacerbations. Logistic regression analyses identified questions with the greatest predictive validity to discriminate among patients and determine cut points for these 3 classifications. Results The final AIRQ comprises 10 equally weighted yes/no impairment and risk questions. The final 10-item models yielded receiver operating characteristic curves of 0.94 to identify well-controlled versus not well-/very poorly controlled and 0.93 to identify well-/not well-controlled versus very poorly controlled asthma, as reflected by the ACT plus prior-year exacerbations standard. Cut points of 0-1, 2-4, and 5-10 best represented well-, not well-, and very poorly controlled asthma. Conclusions AIRQ is a rigorously validated composite measure designed to identify adults and adolescents with varying degrees of asthma control. Ongoing investigations will determine test-retest reliability, responsiveness to change, and predictive ability for future exacerbations.

Objective To estimate the impact of elagolix on work loss due to endometriosis-associated pain. Design Post hoc analysis of data from the Elaris I and II clinical trials. Setting Not applicable. Patient(s) Employed women ages 18–49 years with moderate-to-severe endometriosis-associated pain. Intervention(s) In the two trials, participants were randomized to 6 months of treatment with placebo, elagolix 150 mg once a day, or elagolix 200 mg twice a day. Main Outcome Measure(s) Data on planned work hours, presenteeism, absenteeism, and total work loss (absenteeism + presenteeism) at baseline and month 3 were collected using the Health-Related Productivity Questionnaire. Result(s) This analysis included employed participants from EM-I (n = 672) and EM-II (n = 626). Between baseline and month 3, compared with participants treated with placebo, participants treated with elagolix 150 mg once a day gained > 2 hours total work/week (EM-I, 2.20 ± 1.03; EM-II, 2.65 ± 1.14). Participants treated with 200 mg twice a day gained > 4 hours total work/week (EM-I, 4.91 ± 1.04; EM-II, 4.64 ± 1.14). Both absenteeism and presenteeism were reduced, although most of the gain was due to reduced presenteeism. Estimated cost savings after 6 months of treatment with elagolix were > $1,500 U.S. at 150 mg once a day and > $3,300 U.S. at 200 mg twice a day. Conclusion(s) Compared with placebo, treating moderate-to-severe endometriosis-associated pain with elagolix reduced absenteeism and improved productivity in employed women, which should result in cost savings. Clinical Trial Number(s) NCT01620528 (EM-I) and NCT01931670 (EM-II).

Background Previous research has examined patient perceptions of insulin injection devices. However, a range of injectable medications other than insulin are now used to treat type 2 diabetes. No patient-reported outcome (PRO) instruments have been developed taking into account the perceptions of patients using newer injection devices, which are often different from those used in the past. Therefore, the primary purpose of this study was to evaluate a new PRO instrument focusing on patients’ experiences with injection devices, including those used for newer treatments such as GLP-1 receptor agonists. Methods Patients with T2D treated with non-insulin injectable medications were recruited via advertisements and six clinical sites in the US. All participants completed the draft Diabetes Injection Device - Experience Questionnaire (DID-EQ) and additional measures administered for validity assessment. Participants who had experience with two non-insulin injection devices also completed the draft Diabetes Injection Device - Preference Questionnaire (DID-PQ). Analyses focused on item reduction (item performance, exploratory factor analysis), reliability, and validity. Results One hundred fourty two patients (mean age = 63.0y; 56.3% female) participated. Item reduction yielded a 10-item version of the DID-EQ, including a 7-item Device Characteristics subscale and three global items assessing satisfaction, ease of use, and convenience of the injection device. The DID-EQ demonstrated good internal consistency reliability (Cronbach’s alpha of Device Characteristics subscale = 0.80) and 7-day test-retest reliability (ICCs: 0.92 for Device Characteristics subscale; 0.65 to 0.91 for the three global items). Construct validity was demonstrated via correlations with previously validated instruments (e.g., correlations with the DTSQ treatment satisfaction subscale ranged from 0.56 to 0.60, all p