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Abstract: Purpose: Ethical and legal requirements for healthcare providers in the United States, stipulate that patients sign a consent form prior to undergoing medical treatment or participating in a research study. Currently, the majority of the hospitals obtain these consents using paper-based forms, which makes patient preference data cumbersome to store, search and retrieve. To address these issues, Health Sciences of South Carolina (HSSC), a collaborative of academic medical institutions and research universities in South Carolina, is developing an electronic consenting system, the Research Permissions Management System (RPMS). This article reports the findings of a study conducted to investigate the efficacy of the two proposed interfaces for this system – an iPad-based and touchscreen-based by comparing them to the paper-based and Topaz-based systems currently in use. Methods: This study involved 50 participants: 10 hospital admission staff and 40 patients. The four systems were compared with respect to the time taken to complete the consenting process, the number of errors made by the patients, the workload experienced by the hospital staff and the subjective ratings of both patients and staff on post-test questionnaires. Results: The results from the empirical study indicated no significant differences in the time taken to complete the tasks. More importantly, the participants found the new systems more usable than the conventional methods with the registration staff experiencing the least workload in the iPad and touchscreen-based conditions and the patients experiencing more privacy and control during the consenting process with the proposed electronic systems. In addition, they indicated better comprehension and awareness of what they were signing using the new interfaces. Discussion: The results indicate the two methods proposed for capturing patient consents are at least as effective as the conventional methods, and superior in several important respects. While more research is needed, these findings suggest the viability of cautious adoption of electronic consenting systems, especially because these new systems appear to address the challenge of identifying the participants required for the complex research being conducted as the result of advances in the biomedical sciences. [Copyright &y& Elsevier]

Summary: Objective: The purpose of this paper is to give an overview about the state of the art in research on home telehealth in an international perspective. Method: The study is based on a review of the scientific literature published between 1990 and 2003 and retrieved via Medline in January/February 2004. All together, the abstracts of 578 publications have been analyzed. Results: The majority of publications (44%) comes from the United States, followed by UK and Japan. Most publications deal with vital sign parameter (VSP) measurement and audio/video consultations (“virtual visits”). Publications about IT tools for improved information access and communication as well as decision support for staff, patients and relatives are relatively sparse. Clinical application domains are mainly chronic diseases, the elderly population and paediatrics. Conclusions: Internationally, we observe a trend towards tools and services not only for professionals but also for patients and citizens. However, their impact on the patient–provider relationship and their design for special user groups, such as elderly and/or disabled needs to be further explored. In general, evaluation studies are rare and further research is critical to determine the impacts and benefits, and limitations, of potential solutions and to overcome a number of hinders and restrictions, such as [-] the lack of standards to combine incompatible information systems; [-] the lack of an evaluation framework considering legal, ethical, organisational, clinical, usability and technical aspects; [-] the lack of proper guidelines for practical implementation of home telehealth solutions. [Copyright &y& Elsevier]

The article analyzes the paper, "Use of Existing PRO Instruments and their Modification: Good Research Practices for Evaluating and Documenting Content Validity," written by the Patient-Reported Outcomes (PRO) Task Force of International Society for Pharmacoeconomics & Outcomes Research (ISPOR). It describes a rigorous and practical approach to demonstrate the content validity of a PRO measure. It critically analyzes the steps taken by the U.S. Food and Drug Administration (FDA).