ObjectivesElectronic data capture is increasingly used to improve collection of patient-reported outcome measures in clinical trials and care. The validation of electronic patient-reported outcome devices requires information on patient preference and ease of use. This study conducted usability testing for a General Symptom Questionnaire and Medication Module™ on a handheld device for subjects with osteoarthritis (OA) to determine whether subjects can report on their symptoms and medication use using an electronic diary.MethodsNine subjects with OA participating in a large US mode equivalency study were surveyed independently in this study. Subjects completed a General Symptom Questionnaire and Medication Module™ using the LogPad® LW handheld device. Demographic and technology use information was collected, and the subjects were queried on device usability.ResultsSubjects reported that the handheld device was easy to use and that they were able to complete a General Symptom Questionnaire and Medication Module™ with little or no assistance. They did not report any issues with the screen or size of the device. Subjects were willing to travel with the device to complete electronic diaries at home or in public. Participants indicated that they would be able to use the handheld device to answer questions during a clinical trial. Subjects with OA experienced no physical discomfort during completion of either questionnaire.ConclusionThe General Symptom Questionnaire and Medication Module™ were usable and acceptable to subjects with OA on a handheld device. This was consistent regardless of previous experience and confidence with technology, despite the potential physical restrictions for an OA cohort.

Purpose: Effective health care and patient adherence to their prescribed regimens relies on successful communication between patients and their providers. This study examined mechanisms for optimizing patient–physician communication in subjects with type 2 diabetes, with a focus on optimizing the incorporation of e-clinical technology to improve engagement and communication. Methods: A total of 105 subjects with type 2 diabetes participating in a large US mode equivalency study were surveyed independently of this trial. In addition to demographic information, each subject was queried on their familiarity with and preference for e-clinical technologies. Survey questions focused on mobile technology use, perceptions, and preferences for improving communication and interactions with health care providers. Results: Subjects were diverse in age, sex, education, and ethnicity. Forty nine percent owned a smartphone, and 64% had a computer at home. Most subjects (81%) were interested in using electronic methods (eg, app on a smartphone, email, or text messages) to interact more with physicians between visits. The majority of subjects were interested in using technology to help manage their type 2 diabetes, including 62% favoring communicating with their health-care providers via email and a considerable fraction interested in using smartphones to be provided medication reminders (56%), clinical visit scheduling (55%), and text messaging (49%). Conclusion: Subjects are interested in using electronic methods to increase communication with their physicians and manage their type 2 diabetes. Health-care providers should consider engaging patients with e-clinical technology to increase patient–physician communication and for the ultimate goal of improved health care.

revealed that healthcare-system differences influence payer-preferences for PRO-type (e.g., generic/ disease-specific), influenced primarily by need for cost-effectiveness model. All payers stated that PRO-data provide unique perspective on condition/treatment but considered reimbursement difficult to influence; although stated that PRO-data can positively impact prescribing/MA. Payers reported that in EU, PROs are part of the clinical-evidence considered by HTA reviewing committees. Utility data derived from generic instruments are essential for key EU-markets (excluding Germany). US health plans are interested in PRO measures that are tied to "actionable" endpoints (e.g., adherence/persistence, tolerability, reduction in costs or resource utilisation). CONCLUSIONS: Key drivers for a successful PRO strategy include the development of robust PRO and communication strategy tailored to the needs/ requirements of the end-users (regulators, HTA and MA). Sponsors must continue to bring data based on robust PROs to regulators, HTA and MA and thus bringing the patient, the most affected stakeholder, to the forefront in decision making.OBJECTIVES: To assess current status of disease control and treatment satisfaction in patients with acromegaly in the United States. METHODS: A web-based crosssectional survey was conducted from August -October, 2014. Acromegaly patientreported information on treatment satisfaction and preference, symptom control, and comorbidities were collected and analyzed descriptively. RESULTS: A total of 106 patients completed the survey (mean age: 46 years, female: 76%). Patients had a 5-year diagnosis delay after symptom onset. Most patients (91%) had undergone surgery. Of 68 patients on pharmaceutical therapy: 79% were on somatostatin analogs, 22% on dopamine agonists and 13% on GH-receptor antagonists. Almost half of the patients (47/106) presented with 5 or more comorbidities (depression 57%, hypertension 43%, musculoskeletal and connective tissue abnormalities 42%, sleep apnea 37%, cardiac and cardiovascular diseases 32%, and diabetes 32%). There were 96 (91%) patients reporting acromegaly-related symptoms (e.g. headache, excess sweating, and joint pain). As compared with the low-symptom group 0-3 (n= 41), the high-symptom group with 4+ symptoms (n= 65) were more likely to have depression (OR= 2.33, 95% CI, 1. 05-5.19) and cardiovascular disease (OR= 5.80, 95% CI, 2.02-16.67). Among patients on injectables (n= 61), 61% had worse symptoms toward the end of injection cycle, and 38% requested medical intervention (i.e. additional daily injection, unscheduled injection, or oral medicines). 84% of patients reported that the symptoms interfered with daily life and work; 85% felt frustrated. The treatment satisfaction rate was 56%; 33% didn't like having injections. The top patients' preferences for new acromegaly treatments were to avoid injections (e.g., oral formulation) (85%), improve disease management such as patients' support (62%), and to provide better patient education (57%). CONCLUSIONS: Mo...

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