Preventing Harm From Fluoroscopically Guided Interventional Procedures With a Risk-Based Analysis Approach.

PURPOSE: Fluoroscopically guided interventional (FGI) procedures often have lower complication rates compared with alternative surgical procedures, providing an option for patients with a high risk of perioperative mortality. Although severe radiation injuries are rare, patients receiving peak skin doses exceeding 3 Gy can suffer from radiation-induced tissue injuries, ranging from transient erythema to nonhealing wounds. As these iatrogenic injuries may manifest weeks to months postprocedure, proper diagnosis and timely medical intervention are less likely. Clinically, the lack of situational awareness for monitoring air kerma continues to be a challenge despite the recommendations of numerous organizations on ways to achieve fluoroscopy safety. For patient safety efforts, this study aimed to identify and mitigate systematic gaps associated with potentially high-radiation dose fluoroscopic procedures in US Department of Veterans Affairs (VA) and non-VA medical institutions. METHODS: In this study, a multi-institutional team utilized Healthcare Failure Mode and Effect Analysis (HFMEA) on an example implantable cardioverter defibrillator lead extraction procedure. RESULTS: With this approach, 29 interventions were devised and prioritized by feasibility, cost-effectiveness, and expected clinical impact. Five of the 29 interventions were recommended for immediate implementation or piloting. CONCLUSIONS: This work demonstrates the application of formal risk-based analysis techniques in FGI procedures. These high priority interventions may be valuable for other facilities to consider when performing potentially high-radiation dose procedures and conducting risk-benefit analyses. Formal risk analysis techniques such as the HFMEA process are recommended for other facilities to use to improve safety for their high-risk procedures.

Patient-centered design of an information management module for a personally controlled health record.

BACKGROUND: The development of health information technologies should be informed by iterative experiments in which qualitative and quantitative methodologies provide a deeper understanding of the abilities, needs, and goals of the target audience for a personal health application. OBJECTIVE: Our objective was to create an interface for parents of children with attention-deficit hyperactivity/disorder (ADHD) to enter disease-specific information to facilitate data entry with minimal task burden. METHODS: We developed an ADHD-specific personal health application to support data entry into a personally controlled health record (PCHR) using a three-step, iterative process: (1) a needs analysis by conducting focus groups with parents of children with ADHD and an heuristic evaluation of a prerelease version of a PCHR, (2) usability testing of an initial prototype personal health application following a "think aloud" protocol, (3) performance testing of a revised prototype, and (4) finalizing the design and functionality of the ADHD personal health application. Study populations for the three studies (focus groups and two usability testing studies) were recruited from organizations in the greater Boston area. Study eligibility included being an English- or Spanish-speaking parent who was the primary caretaker of a school-age child with ADHD. We determined subjects' health literacy using the Test of Functional Health Literacy in Adults (TOFHLA). We assessed subjects' task burden using the National Aeronautics and Space Administration (NASA) Task Load Index. To assess the impact of factors associated with the time spent entering data, we calculated Pearson correlation coefficients (r) between time on task and both task burden and subject characteristics. We conducted t tests to determine if time on task was associated with successful task completion. RESULTS: The focus groups included three cohorts: 4 Spanish-speaking parents with diverse health literacy, 4 English-speaking parents with lower health literacy, and 7 English-speaking parents with higher health literacy. Both the initial usability testing cohort (n = 10) and the performance-testing cohort (n = 7) included parents of diverse health literacy and ethnicity. In performance testing, the prototype PCHRs captured patient-specific data with a mean time on task of 11.9 minutes (SD 6.5). Task burden experienced during data entry was not associated with successful task completion (P = .92). Subjects' past computer experience was highly correlated with time on task (r = .86, P = .01), but not with task burden (r = .18, P = .69). The ADHD personal health application was finalized in response to these results by (1) simplifying the visual environment, (2) including items to support users limited by health literacy or technology experience, and (3) populating the application's welcome screen with pictures of culturally diverse families to establish a personal family-oriented look and feel. CONCLUSIONS: Our patient-centered design process produced a usable ADHD-specific personal health application that minimizes the burden of data entry.