Burden of Preterm Labor in the Texas Medicaid Population

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VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8

PIH34 Burden of Preterm Labor in the Texas Medicaid Population Richards KM1, Troeger KA2, Petrilla A3, Agatep B3, Johnsrud M3, Blackwell SC4 of Texas at Austin College of Pharmacy, Austin, TX, USA, 2Hologic, Inc., Marlborough, MA, USA, 3Avalere Health LLC, Washington, DC, USA, 4UT Health, Houston, TX, USA

1University

Objectives: Pregnant women with symptoms of threatened preterm labor (PTL) may be hospitalized for observation; up to half will be discharged and will deliver full term during a subsequent hospitalization. As part of threatened preterm labor screening, fetal fibronectin (fFN) testing may identify women at increased risk for PTL to target appropriate intervention while decreasing unnecessary interventions and hospital admissions for patients determined not to be at risk. This exploratory analysis describes Texas Medicaid enrollees hospitalized with PTL symptoms and evaluates use of diagnostic tests for evaluating risk of PTL.  Methods: Using Texas Medicaid claims data, female enrollees with 1+ hospital admission for PTL between 1/1/2012 and 9/30/2014 were identified through ICD-9-CM diagnosis code 644 and MS/APR DRG codes (780, 565-1 to 565-4). Patients diagnosed with premature rupture of membranes or pre-eclampsia during the same hospitalization, patients with no record of infant delivery, and patients with < 5 months continuous enrollment prior to delivery were excluded. Evidence within 5 months of delivery of outpatient procedures for risk of PTL through fFN tests, transvaginal ultrasound, or other unspecified screening test was assessed.  Results: Overall, 23,794 patients met the criteria for analysis. Mean patient age was 24.4 (±5.4) years and 50.9% identified as Hispanic. Mean length of initial hospital stay was 3.1 (±4.5) days. Of this population, 75.5% had evidence of threatened PTL in the 5-month period prior to delivery. 43.1% had evidence of testing for risk of PTL prior to delivery (12.5% fFN, 40.9% transvaginal ultrasound, 1.6% other unspecified screening test).  Conclusions: Fewer than half of Texas Medicaid patients hospitalized with symptoms of PTL had evidence of testing for threatened PTL. Increased use of diagnostic testing for threatened PTL may rule out low-risk patients and may potentially lower Medicaid expenditures associated with PTL by avoiding or limiting unnecessary hospital admissions.

INDIVIDUAL’S HEALTH – Patient-Reported Outcomes & Patient Preference Studies

preference into the design of ePRO instruments; potentially reducing subject burden and increasing patient engagement in clinical trials. PIH38 Patient Preference for Using Computers, Smartphones, and Internet to Participate in Clinical Trials Khurana L1, Durand EM1, Gary ST1, Otero AV1, Hall C2, Berry K2, Evans CJ2, Dallabrida SM1 Outcomes, Boston, MA, USA

1ERT, Boston, MA, USA, 2Endpoint

Objectives: Patient engagement and adherence are critical to the success of clinical trials. Electronic patient-reported outcomes (ePROs) are increasingly used to evaluate clinical trial endpoints. This study characterized how subjects prefer to use various types of technology to report ePROs in a clinical trial. Considering patient preference during trial design may reduce patient burden and improve patient engagement. Methods: 416 subjects with osteoarthritis (OA, n= 104), type 2 diabetes (n= 102), chronic obstructive pulmonary disease (COPD, n= 103), or depression (n= 107) were surveyed regarding their preferences for using computers, smartphones, and internet in clinical trials.  Results: Subjects were diverse in age, sex, ethnicity, and technology use. 52% reported having a computer at home, 46% reported using the internet daily, and 45% reported owning a smartphone. Subjects reported that they would be willing to participate in a clinical trial using the internet for up to 1 month (25%), 2-6 months (19%), 1-2 years (14%), or 5+ years (15%). Similarly, subjects were willing to participate in a clinical trial using a smartphone for up to 1 month (25%), 2-6 months (22%), 1-2 years (12%), or 5+ years (14%). When asked what time of day they would prefer to complete a daily electronic diary, subjects preferred 8pm-midnight (26%), 8am-noon (21%), or 4pm-8pm (15%). Subjects thought it would be necessary (14%) or helpful (69%) to have an audible alarm to remind them to record their symptoms. In a multi-select question, subjects preferred to report their symptoms once a day for a clinical trial using a provisioned smartphone (49%), internet (46%), or an application on their personal smartphone (42%).  Conclusions: Subjects are willing to use computers, smartphones, and internet in a clinical trial setting. Trial sponsors should consider patient preferences for specific technology features to reduce patient burden and improve engagement and adherence when using ePRO assessments.

PIH36 Screening Cost-Related Medication Non-Adherence: A BIG DATA APPROACH

PIH39 Development and Evaluation of a Crosswalk between the Eq-5d-5l And Menopause-Specific Quality of Life (Menqol) Questionnaire in Postmenopausal Women

Zhang J1, Meltzer D2 University of Chicago, Chicago, IL, USA, 2University of Chicago, Chicago, IL, USA

1Pfizer

1The

Objectives: Millions of Americans encounter access barriers to medication due to cost. However, to date, there is no effective screening tool that identifies patients at risk of cost-related medication non-adherence (CRN). By utilizing a big-data approach, we aimed to develop a novel method of identifying patients at risk of CRN.  Methods: By matching the dates of patients’ receipt of monthly social security (SS) payments and the dates of prescription orders for 559 Medicare beneficiaries who were primary SS claimants at high risk of hospitalization in an urban academic medical center, we identified patients who ordered their outpatient prescription within two days of receipt of monthly SS payments in 2014. We assessed the predictive power of this information on CRN, using multivariate logistic regression analysis.  Results: Among the 559 Medicare patients at high risk of hospitalization, 137 (25%) reported CRN. Among those with CRN, 96 (70%) had ordered prescriptions on receipt of SS payments one or more times in 2014. The area under Receiver Operating Curve was 0.70 using the predictive model in multivariate logistic regression analysis.  Conclusions: Ordering prescription upon receipt of SS check is informative of cost-related medication non-adherence. The big-data approach is a valuable tool to screen patients at risk of CRN, and can be further expanded to the general population and subpopulations, providing a meaningful risk-stratification for CRN, and facilitating physician-patient communication to reduce CRN. PIH37 Patient Preference for Display of Electronic Patient-Reported Outcomes: Wording Emphasis, Question Format, and Navigation Button Placement Khurana L1, Durand EM1, Gary ST1, Otero AV1, Hall C1, Ryan A2, Evans CJ2, Dallabrida SM1 1ERT, Boston, MA, USA, 2Endpoint Outcomes, Boston, MA, USA

Objectives: Electronic patient-reported outcomes (ePROs) are a reliable method for collecting patient data during clinical trials and offer many advantages over paper collection; however, it is essential to consider patient preference and ease of use when employing this technology. Improving the usability of ePRO in clinical trials could ultimately reduce subject burden and improve subject engagement.  Methods: 416 subjects with osteoarthritis (OA, n= 104), type 2 diabetes (n= 102), chronic obstructive pulmonary disease (COPD, n= 103), or depression (n= 107) were surveyed regarding their preferences for ePRO display. Results: Subject preferences were similar across the four therapeutic areas. When presented with options for showing emphasis in a sentence, subjects thought that underlining best drew attention to emphasized words (37%), followed by capitalized (27%) or bold (23%) lettering. Subjects were shown screens of a multi-select question formatted to read left to right (question to the left of the answers) or top to bottom (question above the answers). 43% could read and understand the screens equally. Of those with a preference, 71% preferred the top to bottom format. Subjects were shown screens of a tablet computer ePRO device with either one question per screen or several multi-select questions per screen in a matrix format. 59% preferred one question per screen because it was easier to read (63%). 41% preferred multiple questions per screen because it was faster to complete (50%). Subjects were shown two screens with “back” and “next” navigation buttons at either the top or bottom of the screen. 30% thought it was equally easy to find the buttons; of those with a preference, 70% preferred them at the bottom of the screen.  Conclusions: When possible, questionnaire designers should consider these results to incorporate patient

Bushmakin AG1, Tatlock S2, Williamson N2, Moffatt M3, Arbuckle R2, Abraham L4, Coon C5 Inc, Groton, CT, USA, 2Adelphi Values Ltd, Bollington, UK, 3Pfizer Inc, New York, NY, USA, 4Pfizer, Inc., Surrey, UK, 5Outcometrix, Tucson, AZ, USA

Objectives: Postmenopausal (PM) women taking hormone therapies (HT) can experience side effects (breast pain/vaginal bleeding), impacting quality of life and increasing likelihood of discontinuation. The sensitivity of the EQ-5D-5L in PM women on HT is unknown. The purpose of this research was to develop a crosswalk between scores from the Menopause-Specific Quality of Life questionnaire (MENQOL) and EQ-5D-5L and assess sensitivity.  Methods: The MENQOL and EQ-5D-5L were co-administered to 351 PM women in an observational, noninterventional study. Total MENQOL scores were mapped onto EQ-5D-5L utilities using repeated measures regression (RMM) with MENQOL scores as a continuous predictor. The predictability, goodness-of-fit and signs of the estimated coefficients were assessed in sensitivity analyses using averaged scores over time in an Ordinary Least-Square regression (OLS) and using MENQOL scores as a categorical predictor in a RMM.  Results: The sample consisted of n= 276 PM women (n= 202 on HT, side effects; n= 74 on HT, no side effects; n= 75 not on HT). Mean age was 53.7 (SD 6.6) years. The main model (employing MENQOL total score as a continuous variable), showed sizable and significant correlation with the EQ-5D-5L (-0.589; P< .001) and a relationship of EQ-5D-5L= 0.992-0.042× MENQOL. EQ-5D-5L mean scores (on HT, side effects=  0.854 [SD 0.12]; on HT, no side effects= 0.927 [SD 0.11]; not on HT= 0.836 [SD 0.11]) were comparable to those estimated in the main model (on HT, side effects= 0.865 [SD 0.07]; on HT, no side effects= 0.909 [SD 0.05]; not on HT= 0.833 [SD 0.06]) on a scale of -0.11 to 1. Linearity assumptions were supported by RMM with MENQOL scores as a categorical predictor. Goodness-of-fit was moderate (R2= 0.347; Root mean squared error= 0.093) using OLS with averaged scores over time.  Conclusions: The crosswalk performed in this study supports conversion of MENQOL scores to EQ-5D-5L derived health utilities and can be used for grouplevel analyses of utilities in PM women. PIH40 Measuring Treatment Satisfaction in Erectile Dysfunction: Use of A Person-Item Map Bushmakin AG1, Cappelleri JC2, Stecher V3, Lue TF4 1Pfizer Inc, Groton, CT, USA, 2Pfizer, Inc, Groton, CT, USA, 3Pfizer Inc, New York, NY, USA, 4University of California San Francisco, San Francisco, CA, USA

Objectives: To enhance interpretation of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire in men with ED via construction of a person-item map (PIM).  Methods: Men aged 18–65 years with documented ED received sildenafil (50 mg, 100 mg) or placebo for 8 weeks in randomized doubleblind manner. Post-hoc analyses were conducted on EDITS data (11 items rating satisfaction; each score range: 0 to 4). Confirmatory factor analysis (CFA) tested the assumption of unidimensionality of EDITS. To construct the PIM, Rasch analysis was utilized. Responses to each item were dichotomized: no change/worsening (responses 0, 1, or 2) or improvement (responses 3 or 4).  Results: Analyses were performed on data from 278 subjects who completed EDITS at end of double-blind treatment. CFA supported the unidimensionality assumption of EDITS. The CFI fit index was 0.93; all standardized paths were statistically significant and > 0.4. In the PIM analysis, item 4 (ease of use of treatment) was the easiest to endorse, followed by item 3 (likelihood of continuing treatment) and item 7 (confidence in ability to engage in sexual activity). The most difficult item to endorse was item 2 (degree