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<p class="abstract"><span lang="EN-IN">Rater training is a well-recognized approach to minimizing inaccuracy and variability in clinical outcomes assessments common in clinical trials. However, there is a dearth of empirical research on the types of rater training and qualifications that contribute to improved accuracy, inter-rater reliability and intra-rater reliability. Herein, we discuss the need for rater training in clinical trials and review publications that report data on rater characteristics, training modalities and outcomes in terms of accuracy and reliability of clinical outcomes data. </span></p><p> </p>

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.

Patient registries are important tools for health care research. The goal of this project, sponsored by the Agency for Healthcare Research and Quality (AHRQ), is to design and implement the Registry of Patient Registries (RoPR), the first searchable, public database designed specifically to provide information about registries. The RoPR is integrated with ClinicalTrials.gov, supports research collaboration, reduces redundancy, and improves transparency in observational clinical research. METHODS: The RoPR consists of a registration system and a public search Web site. The registration system collects over forty data elements which define a registry profile. The search site serves as a central listing of registries and includes options to filter for relevant profiles. RoPR registration is integrated with ClinicalTrials.gov: users registering a study on ClinicalTrials.gov who designate it as a patient registry are presented with a pop-up window displaying the RoPR registration system. Users complete and submit the requested data elements, creating a registry profile in the RoPR that is linked to the ClinicalTrials.gov listing through a unique identifier, the NCT ID. RESULTS: The RoPR was launched on December 1, 2012. As of January 11, 2013, 54 new patient registries are registered on ClinicalTrials.gov. Twelve of these have been fully published in the RoPR, representing 21 different condition areas. Most are classified as disease/disorder/condition (67%), drug (33%), and/or procedure (33%) registries. Reported registry purposes include effectiveness (50%), safety or harm (42%), natural history of disease (42%) and clinical practice assessment (33%). A total of 67% of registry sponsors are open to being contacted for collaboration, data access, investigator or patient participation, or for information requests. CONCLUSIONS: The RoPR is a searchable Web site used by registry sponsors to publish information about registries and by members of the public to search for information about existing registries. Integration with ClinicialTrials.gov presents a user-friendly interface to encourage registration.

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.