Search

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.

**Background:** Hepatitis C virus (HCV) infection and its treatments are associated with significant symptoms, side effects and impact on patients functioning. The Hepatitis C Symptom and Impact Questionnaire version 4 (HCV-SIQv4) was developed according to FDA Patient Reported Outcomes (PRO) Guidance, for evaluating chronic HCV infection and its treatment. **Objectives:** This study evaluated the psychometric properties and clinically important change (CIC) thresholds of the measure. **Methods:** PRO data were pooled from three Phase IIb and III trials evaluating interferon-free simeprevircontaining regimens for treatment of chronic HCV infection. Scale range adequacy, reliability, validity, responsiveness and CIC thresholds were assessed incorporating knowledge of the appropriate measurement model. **Results:** Data from 437 patients were analyzed. Stage of liver disease was associated with symptom severity and functioning at baseline. Reliability was acceptable (test-retest ICC ≥0.7) for most scores except the Gastrointestinal and Integumentary domains. Convergent validity was observed between HCV-SIQv4 scores and concurrent measures of conceptual similarity. Greater symptom severity and worse impact scores were associated with liver cirrhosis, depression, severe fatigue and health limitations. Patients who achieved SVR12 had better outcomes than those failing to. HCV-SIQv4 symptom and domain scores were responsive to changes in health state (effect sizes ≥0.5). Exploratory thresholds for change in scores indicating a clinically important improvement and worsening were HCV-SIQv4 Overall Body System Score (BSS), 8 and 8; Constitutional BSS, 10 and 10; Gastrointestinal BSS, 5 and 5; Psychiatric BSS, 8 and 8; Neurocognitive BSS, 8 and 8; and Integumentary BSS, 5 and 5. **Conclusions:** The HCV-SIQv4 offers reliable, responsive assessments within HCV clinical development. CIC thresholds are now available to aid score interpretation.

Introduction Patient-reported outcomes (PROs) predict overall survival (OS) in many cancer types, but there is little evidence of their prognostic value in older patients with acute myeloid leukemia (AML). We examined whether the Functional Assessment of Cancer Therapy – Leukemia (FACT-Leu) predicted OS beyond established prognostic factors among these patients. Materials and Methods Data were from AML2002 (n = 309), a randomized phase 2/3 study comparing decitabine plus talacotuzumab versus decitabine alone in older AML patients ineligible for intensive chemotherapy. We used ridge-penalized Cox proportional hazards models to estimate the association between baseline FACT-Leu scales and OS. We then conducted a bootstrap analysis to determine how often FACT-Leu scales appeared in forward- and backward- selected “final models” predicting OS relative to prognosticators from the AML Composite Model (AML-CM; e.g., chronic comorbidities, previous cancer, cytogenetic/molecular risk). Results In ridge-penalized models, the FACT-Leu Physical Well-Being (PWB), Trial Outcomes Index (TOI), and Total scales predicted OS. Adjusting for AML-CM factors, an important increase (3 points) in PWB score was associated with a 14% reduction in the hazard of death. In the bootstrap analysis, the PWB scale appeared in 93% of backward- and 98% of forward selected models, while the TOI [57% (backward), 79% (forward)] and FACT-Leu Total [51% (backward), 78% (forward)] appeared less often in final models. Discussion and Conclusions These results indicate PROs' value for predicting outcomes among older AML patients and underscore the need to more systematically collect PRO data in routine care with these patients. ClinicalTrials.gov Registration: NCT02472145

Introduction NSCLCs account for most lung cancers; approximately 30% involve a mutation in the EGFR gene. This study sought to identify one or more patient-reported outcome (PRO) measures relevant for use in clinical trials to assess symptoms and health-related quality of life in this population. Methods Patients with NSCLC from the United States, Europe, and Asia and including those with an exon 20 insertion mutation and other EGFR mutations participated in a combination of concept elicitation and cognitive debriefing interviews to report symptoms and impacts of their NSCLC and provide feedback on the clarity and relevance of several PRO measures. Results A total of 30 individuals participated (mean age = 57 years, 87% female, 80% white). The most often reported symptoms included fatigue, shortness of breath, cough, and weight loss. Individuals with the exon 20 insertion mutation (n = 21) more frequently reported negative impacts on daily life, physical functioning, and social functioning but less frequently reported negative impacts to emotional functioning. The PROMIS Short-Form version 2.0—Physical Function 8c and the NSCLC Symptom Assessment Questionnaire were deemed clear, relevant, and easy to complete. The concepts identified during the concept elicitation portion of the interviews were mapped to the content of each PRO, and all items within both PROs were endorsed by at least 20% of the participants. Conclusions These results support the content validity, clarity, and relevance of the PROMIS Short-Form version 2.0—Physical Function 8c and the NSCLC Symptom Assessment Questionnaire in a population with EGFR-mutated NSCLC. Both would be appropriate for inclusion in future studies.

BACKGROUND The objective of this study was to validate the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) in patients with acute myeloid leukemia (AML) who are not candidates for intensive therapy. METHODS A sample of 317 patients with AML who were not eligible for intensive chemotherapy completed the FACT-Leu and EuroQol 5-Dimension (EQ-5D) measures (Utility Index and Visual Analogue Scale) every 28 days until the end of treatment. Internal consistency reliability was estimated with Cronbach's α. Concurrent validity was examined with correlations between FACT-Leu and EQ-5D scales, and known-groups validity was examined by determining whether FACT-Leu scales distinguished between Eastern Cooperative Oncology Group (ECOG) performance status ratings (PSRs) and between maximum adverse event toxicities at the baseline. This study examined responsiveness to change by anchoring change in the FACT-Leu scales to a 0.10 change in the EQ-5D Health Utility Index. RESULTS Cronbach's α usually exceeded the threshold for good (≥0.80) or excellent reliability (≥0.90). Correlations between FACT-Leu and EQ-5D scales were moderate (r > 0.50) or high (r > 0.70). FACT-Leu scales distinguished between ECOG PSR groups with large effect sizes for an ECOG PSR of 0 versus an ECOG PSR of 2 (0.50 ≤ d

Objectives To explore the feasibility of using social media–based patient networks to gather qualitative data on patient-reported outcome (PRO) concepts relevant to chronic lymphocytic leukemia (CLL). Methods Between August and November 2013, US-residing members of the PatientsLikeMe online CLL patient community completed open-ended web-based surveys designed to elicit descriptions of CLL symptoms, impacts, and treatment-related perceptions. Qualitative telephone follow-up interviews were conducted with a subsample of respondents. Survey responses and interview transcripts were coded for qualitative analysis using Atlas.ti. Results Fifty survey responses were included in the analyses. Participants were age 60.5 ± 6.9 years, 54% female, and 96% white. When surveyed, 20% were receiving current treatment, 16% were in remission, and 64% were treatment-naive. Among respondents, 369 descriptions of CLL symptoms were coded. Fatigue-related symptoms were expressed most frequently, with 54% reporting “fatigue,” “tiredness,” or both in their responses. These concepts were followed by night sweats (38%), swollen lymph nodes (32%), and frequent infections (28%). Among impacts of CLL, worry and fear (66% of respondents), depressed feelings (52%), and work limitations (50%) were noted most frequently. Conclusions Survey results identified constitutional symptoms of CLL included in existing PRO instruments and the literature. Although the findings suggest that qualitative data obtained through social media applications can be potentially useful in supporting concept identification for newly developed PRO instruments, they also indicate that online approaches alone may not be sufficient to achieve efficient and exhaustive concept elicitation. Further research is needed to identify whether the results can support content validity in the same way as established qualitative research methods.

7532 Background: Patient-reported outcomes (PROs) predict overall survival (OS) in solid cancer populations, but little evidence exists around the prognostic value of PROs in patients with hematologic malignancies. We investigated whether scales from the Functional Assessment of Cancer Therapy – Leukemia (FACT-Leu) predicted OS beyond established prognostic factors. Methods: Data were from 317 AML patients unfit for intensive therapy from a clinical trial comparing Dacogen (decitabine) plus Talacotuzumab versus Dacogen (decitabine) alone (AML2002; NCT02472145). We used ridge-penalized Cox models to determine whether baseline (1st cycle) FACT-Leu scales predicted OS. FACT-Leu scales significant in these models and factors from a validated prognostic model, the AML composite model (AML-CL; covariates listed in Table), were entered into Cox proportional hazard models. Lastly, model selection procedures were run with 1000 bootstrapped samples using all variables. The inclusion frequency of each FACT-Leu scale in the final models was examined to evaluate prognostic value for OS (i.e., higher the % of inclusion, higher importance of the variable). Results: In the ridge-penalized Cox models, the Physical Wellbeing Scale (PWB), Trial Outcome Index (TOI), and FACT-Leu Total scales were significant predictors of OS. After adjusting for the AML-CL factors, an important difference (2 pts) in PWB score was associated with a 9% decline in OS. (Table) Model validity was evidenced as the PWB scale appeared in a large majority of selected models (90%-97%), while the TOI (45%-73%) and FACT-Leu Total (41%-71%) appeared less often. Conclusions: FACT-Leu scales, especially the PWB, were significant prognostic factors for OS among AML patients not suitable for intensive therapy. These results may indicate PROs' value as stratification factors in trials with AML patients and underscore the need to more systematically collect PRO data in routine care practice with AML patients. Clinical trial information: NCT02472145 . [Table: see text]

Introduction: Acute Myeloid Leukemia (AML) is an aggressive disease associated with poor health related quality of life (HRQoL) and short overall survival (OS), particularly for patients' ineligible for intensive chemotherapy. The HRQoL was evaluated in a cohort of patients with AML who were not considered eligible for standard chemotherapy based on the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) collected at baseline of AML2002 study (NCT02472145). Methods: This analysis was based on a randomized, phase 2/3, parallel design study conducted in patients with AML. Patients' perceptions to HRQoL were evaluated using a 44-item, self-reported leukemia-specific measure, FACT-Leu. It was assessed based on 5 subscales: physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB) and leukemia-specific concerns. Additionally, FACT-Leu was also evaluated based on the trial outcome index (TOI). European Quality of Life- 5 Dimension 5-Level (EQ-5D-5L) was reported based on index values and visual analogue scale (VAS). The summary statistics from the FACT-Leu was compared to the validation paper [1]. FACT-Leu by eastern cooperative oncology group (ECOG) performance status score was also assessed based on generalized linear model and the correlation among FACT-leu subscales was assessed using the Pearsons correlation coefficient Results: Of the 309 patients (mean age 74.9 years) enrolled, 46.3% were women, 87.3% were white (Caucasian) and 70.9% had de novo AML. For these patients, ECOG performance status distribution was 0 (18%), 1 (41.9%) and 2 (40.2%). At baseline, the mean index values for VAS of EQ-5D-5L were 0.68 and 62.5, respectively, and the mean FACT-Leu was 119.6. Except SWB, other FACT-Leu subscale and aggregated scores highly correlated with FACT-Leu (0.74-0.96; p Conclusions: FACT-Leu scores were significantly associated with PS and sex. The lower mean subscale scores in Patients with AML ineligible for intensive chemotherapy highlight the need for new therapies to improve patient HRQoL in this group of patients and suggested that there is a need for optimized instruments for women. The FACT-Leu tool could facilitate targeted population interventions, potentially improving quality of life. [1] Cella, Value in Health 15 (2012) 1051-1058 Disclosures He: Janssen Global services: Employment. Pierson:Janssen Global Services LLC: Employment. Loefgren:Janssen Global Services LLC: Employment. Cella:Pfizer: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Janssen Global services: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding.

11061Background: T is recently approved in the US for treatment of advanced LMS or LPS after prior chemotherapy failure based on results from a randomized, phase-3 study (Demetri et al, 2015, J Cli...

We summarize the results of a project to develop evolutionary computing methods for the design of behaviors of embodied agents in the form of autonomous vehicles. We conceived and implemented a strategy called graduated embodiment. This method allows high-level behavior algorithms to be developed using genetic programming methods in a low-fidelity, disembodied modeling environment for migration to high-fidelity, complex embodied applications. This project applies our methods to the problem domain of robot navigation using adaptive waypoints, which allow navigation behaviors to be ported among autonomous mobile robots with different degrees of embodiment, using incremental adaptation and staged optimization. Our approach to biomimetic behavior engineering is a hybrid of human design and artificial evolution, with the application of evolutionary computing in stages to preserve building blocks and limit search space. The methods and tools developed for this project are directly applicable to other agent-based modeling needs, including climate-related conflict analysis, multiplayer training methods, and market-based hypothesis evaluation.

e17692 Background: We sought to identify patient-reported disease symptoms and concerns relevant to patients with Chronic Lymphocytic Leukemia (CLL) who have experienced treatment versus watch and ...