Immunolab: Combining targeted real-world data with advanced analytics to generate evidence at scale in immunology.

Real-world evidence (RWE) has traditionally been used by regulatory or payer authorities to inform disease burden, background risk, or conduct post-launch pharmacovigilance, but in recent years RWE has been increasingly used to inform regulatory decision-making. However, RWE data sources remain fragmented, and datasets are disparate and often collected inconsistently. To this end, we have constructed an RWE-generation platform, Immunolab, to facilitate data-driven insights, hypothesis generation and research in immunological diseases driven by type 2 inflammation. Immunolab leverages a large, anonymized patient cohort from the Optum electronic health record and claims dataset containing over 17 million patient lives. Immunolab is an interactive platform that hosts three analytical modules: the Patient Journey Mapper, to describe the drug treatment patterns over time in patient cohorts; the Switch Modeler, to model treatment switching patterns and identify its drivers; and the Head-to-Head Simulator, to model the comparative effectiveness of treatments based on relevant clinical outcomes. The Immunolab modules utilize various analytic methodologies including machine learning algorithms for result generation which can then be presented in various formats for further analysis and interpretation.

Utilizing information technology to mitigate the handoff risks caused by resident work hour restrictions.

BACKGROUND: Resident duty hours have been restricted to 80 per week, a limitation thought to increase patient safety by allowing adequate sleep. Yet decreasing work hours increases the number of patient exchanges (so-called "handoff") at the end of shifts. WHERE ARE WE NOW?: A greater frequency of handoff leads to an increased risk of physician error. Information technology can be used to minimize that risk. WHERE DO WE NEED TO GO?: A computer-based expert system can alleviate the problems of data omissions and data overload and minimize asynchrony and asymmetry. A smart system can further prompt departing physicians for information that improves their understanding of the patient's condition. Likewise, such a system can take full advantage of multimedia; generate a study record for self-improvement; and strengthen the interaction between specialists jointly managing patients. HOW DO WE GET THERE?: There are impediments to implementation, notably requirements of the Health Insurance Portability and Accountability Act; medical-legal ramifications, and computer programming costs. Nonetheless, the use of smart systems, not to supplant physicians' rational facilities but to supplement them, promises to mitigate the risks of frequent patient handoff and advance patient care. Thus, a concerted effort to promote such smart systems on the part of the Accreditation Council for Graduate Medical Education (the source of the duty hour restrictions) and the Association of American Medical Colleges (representing medical schools and teaching hospitals) may be effective. We propose that these organizations host a contest for the best smart handoff systems and vigorously promote the winners.

National survey of patients' bill of rights statutes.

BACKGROUND: Despite vigorous national debate between 1999-2001 the federal patients' bill of rights (PBOR) was not enacted. However, states have enacted legislation and the Joint Commission defined an accreditation standard to present patients with their rights. Because such initiatives can be undermined by overly complex language, we surveyed the readability of hospital PBOR documents as well as texts mandated by state law. METHODS: State Web sites and codes were searched to identify PBOR statutes for general patient populations. The rights addressed were compared with the 12 themes presented in the American Hospital Association's (AHA) PBOR text of 2002. In addition, we obtained PBOR texts from a sample of hospitals in each state. Readability was evaluated using Prose, a software program which reports an average of eight readability formulas. RESULTS: Of 23 states with a PBOR statute for the general public, all establish a grievance policy, four protect a private right of action, and one stipulates fines for violations. These laws address an average of 7.4 of the 12 AHA themes. Nine states' statutes specify PBOR text for distribution to patients. These documents have an average readability of 15th grade (range, 11.6, New York, to 17.0, Minnesota). PBOR documents from 240 US hospitals have an average readability of 14th grade (range, 8.2 to 17.0). CONCLUSIONS: While the average U.S. adult reads at an 8th grade reading level, an advanced college reading level is routinely required to read PBOR documents. Patients are not likely to learn about their rights from documents they cannot read.

Notices of Privacy Practices: a survey of the Health Insurance Portability and Accountability Act of 1996 documents presented to patients at US hospitals.

BACKGROUND: Federal regulation requires hospitals to present patients with a Notice of Privacy Practices (NPP) that contains all stipulated content items, is readable by patients, and posted on institutional web sites. OBJECTIVE: The objective of this study was to determine whether the NPP texts contain the required content, if readability is influenced by local literacy rates, and if readability or the presentation of NPP texts in other languages is influenced by local rates of English proficiency. RESEARCH DESIGN: The authors conducted a cross-sectional study of the web sites of 115 hospitals selected from the US News and World Report list: Best Hospitals in America. MEASURES: English NPP texts were evaluated for 18 content items and readability using the Flesch-Kincaid scale, which assigns the minimal grade level required to read a text (range, 0-16). RESULTS: NPP texts were available for all hospitals (115 of 115). A Spanish-language NPP was available for 25% (29 of 115). All content items were evident in 76% (87 of 115) of hospitals' NPP texts. The average grade-level readability of NPP text was 12.3 (95% confidence interval, 12.0-12.7). Readability was not associated with the rate of local literacy (P = 0.07). Hospitals with a lower local rate of English proficiency had NPP texts that were more difficult to read (P = 0.03) and did not present NPP texts in other languages more frequently (P = 0.15). CONCLUSIONS: Although NPP texts typically cover the stipulated content, they are written beyond the reading capacity of the majority of American adults. Explicit federal guidance is needed to help privacy lawyers draft NPP texts that are both comprehensive and comprehensible. The goals of the Health Insurance Portability and Accountability Act of 1996 Privacy Rule cannot be met with NPP texts patients cannot decipher.