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Objectives: To explore (1) differences in validity and feasibility ratings for geriatric surgical standards across a diverse stakeholder group (surgeons vs. nonsurgeons, health care providers vs. nonproviders, including patient-family, advocacy, and regulatory agencies); (2) whether three multidisciplinary discussion subgroups would reach similar conclusions.Data Source/study Setting: Primary data (ratings) were reported from 58 stakeholder organizations.Study Design: An adaptation of the RAND-UCLA Appropriateness Methodology (RAM) process was conducted in May 2016.Data Collection/extraction Methods: Stakeholders self-administered ratings on paper, returned via mail (Round 1) and in-person (Round 2).Principal Findings: In Round 1, surgeons rated standards more critically (91.2 percent valid; 64.9 percent feasible) than nonsurgeons (100 percent valid; 87.0 percent feasible) but increased ratings in Round 2 (98.7 percent valid; 90.6 percent feasible), aligning with nonsurgeons (99.7 percent valid; 96.1 percent feasible). Three parallel subgroups rated validity at 96.8 percent (group 1), 100 percent (group 2), and 97.4 percent (group 3). Feasibility ratings were 76.9 percent (group 1), 96.1 percent (group 2), and 92.2 percent (group 3).Conclusions: There are differences in validity and feasibility ratings by health professions, with surgeons rating standards more critically than nonsurgeons. However, three separate discussion subgroups rated a high proportion (96-100 percent) of standards as valid, indicating the RAM can be successfully applied to a large stakeholder group. [ABSTRACT FROM AUTHOR]

Background: People who inject drugs (PWID) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). Treatment of PWID is complex due to addiction, mental illness, poverty, homelessness, lack of positive social support, poor adherence-related skills, low motivation and knowledge, and poor access to and trust in the health care system. New direct-acting antiviral medications are available for HCV with high cure rates and few side effects. The life expectancy and economic benefits of new HCV treatments will not be realized unless we determine optimal models of care for the majority of HCV-infected patients. The purpose of this study is to evaluate the effectiveness of directly observed therapy and group treatment compared with self-administered individual treatment in a large, urban opioid agonist therapy clinic setting in the Bronx, New York.Methods/design: In this randomized controlled trial 150 PWID with chronic HCV were recruited from opioid agonist treatment (OAT) clinics and randomized to one of three models of onsite HCV treatment in OAT: 1) modified directly observed therapy; 2) group treatment; or 3) control - self-administered individual treatment. Participants were age 18 or older, HCV genotype 1, English or Spanish speaking, treatment naïve (or treatment experienced after 12/3/14), willing to receive HCV treatment onsite, receiving methadone or buprenorphine at the medication window at least once per week, and able to provide informed consent. Outcomes of interest include adherence (as measured by self-report and electronic blister packs), HCV treatment completion, sustained virologic response, drug resistance, and cost-effectiveness.Discussion: This paper describes the design and rationale of a randomized controlled trial comparing three models of care for HCV therapy delivered in an opioid agonist treatment program. Our trial will be critical to rigorously identify models of care that result in high adherence and cure rates. Use of blister pack technology will help us determine the role of adherence in successful cure of HCV. Moreover, the trial methodology outlined here can serve as a template for the development of future programs and studies among HCV-infected drug users receiving opioid agonist therapy, as well as the cost-effectiveness of such programs.Trial Registration: This trial was registered with ClinicalTrials.gov ( NCT01857245 ). Trial registration was obtained prospectively on May 20th, 2013. [ABSTRACT FROM AUTHOR]