Impact of electronic health records on malpractice claims in a sample of physician offices in Colorado: a retrospective cohort study.

BACKGROUND: Electronic health records (EHRs) might reduce medical liability claims and potentially justify premium credits from liability insurers, but the evidence is limited. OBJECTIVES: To evaluate the association between EHR use and medical liability claims in a population of office-based physicians, including claims that could potentially be directly prevented by features available in EHRs ("EHR-sensitive" claims). DESIGN: Retrospective cohort study of medical liability claims and analysis of claim abstracts. PARTICIPANTS: The 26 % of Colorado office-based physicians insured through COPIC Insurance Company who responded to a survey on EHR use (894 respondents out of 3,502 invitees). MAIN MEASURES: Claims incidence rate ratio (IRR); prevalence of "EHR-sensitive" claims. KEY RESULTS: 473 physicians (53 % of respondents) used an office-based EHR. After adjustment for sex, birth cohort, specialty, practice setting and use of an EHR in settings other than an office, IRR for all claims was not significantly different between EHR users and non-users (0.88, 95 % CI 0.52-1.46; p = 0.61), or for users after EHR implementation as compared to before (0.73, 95 % CI 0.41-1.29; p = 0.28). Of 1,569 claim abstracts reviewed, 3 % were judged "Plausibly EHR-sensitive," 82 % "Unlikely EHR-sensitive," and 15 % "Unable to determine." EHR-sensitive claims occurred in six out of 633 non-users and two out of 251 EHR users. Incidence rate ratios were 0.01 for both groups. CONCLUSIONS: Colorado physicians using office-based EHRs did not have significantly different rates of liability claims than non-EHR users; nor were rates different for EHR users before and after EHR implementation. The lack of significant effect may be due to a low prevalence of EHR-sensitive claims. Further research on EHR use and medical liability across a larger population of physicians is warranted.

Wrong-site and wrong-patient procedures in the universal protocol era: analysis of a prospective database of physician self-reported occurrences.

OBJECTIVE: To determine the frequency, root cause, and outcome of wrong-site and wrong-patient procedures in the era of the Universal Protocol. DESIGN: Analysis of a prospective physician insurance database performed from January 1, 2002, to June 1, 2008. Deidentified cases were screened using predefined taxonomy filters, and data were analyzed by evaluation criteria defined a priori. SETTING: Colorado. PATIENTS: Database contained 27 370 physician self-reported adverse occurrences. MAIN OUTCOME MEASURES: Descriptive statistics were generated to examine the characteristics of the reporting physicians, the number of adverse events reported per year, and the root causes and occurrence-related patient outcomes. RESULTS: A total of 25 wrong-patient and 107 wrong-site procedures were identified during the study period. Significant harm was inflicted in 5 wrong-patient procedures (20.0%) and 38 wrong-site procedures (35.5%). One patient died secondary to a wrong-site procedure (0.9%). The main root causes leading to wrong-patient procedures were errors in diagnosis (56.0%) and errors in communication (100%), whereas wrong-site occurrences were related to errors in judgment (85.0%) and the lack of performing a "time-out" (72.0%). Nonsurgical specialties were involved in the cause of wrong-patient procedures and contributed equally with surgical disciplines to adverse outcome related to wrong-site occurrences. CONCLUSIONS: These data reveal a persisting high frequency of surgical "never events." Strict adherence to the Universal Protocol must be expanded to nonsurgical specialties to promote a zero-tolerance philosophy for these preventable incidents.

Evidence-based toxicology: a comprehensive framework for causation.

This paper identifies deficiencies in some current practices of causation and risk evaluation by toxicologists and formulates an evidence-based solution. The practice of toxicology focuses on adverse health events caused by physical or chemical agents. Some relations between agents and events are identified risks, meaning unwanted events known to occur at some frequency. However, other relations that are only possibilities--not known to occur (and may never be realized)--also are sometimes called risks and are even expressed quantitatively. The seemingly slight differences in connotation among various uses of the word 'risk' conceal deeply philosophic differences in the epistemology of harm. We label as 'nomological possibilities' (not as risks) all predictions of harm that are known not to be physically or logically impossible. Some of these nomological possibilities are known to be causal. We term them 'epistemic'. Epistemic possibilities are risks. The remaining nomological possibilities are called 'uncertainties'. Distinguishing risks (epistemic relationships) from among all nomological possibilities requires knowledge of causation. Causality becomes knowable when scientific experiments demonstrate, in a strong, consistent (repeatable), specific, dose-dependent, coherent, temporal and predictive manner that a change in a stimulus determines an asymmetric, directional change in the effect. Many believe that a similar set of characteristics, popularly called the 'Hill Criteria', make it possible, if knowledge is robust, to infer causation from only observational (nonexperimental) studies, where allocation of test subjects or items is not under the control of the investigator. Until the 1980s, medical decisions about diagnosis, prevention, treatment or harm were often made authoritatively. Rather than employing a rigorous evaluation of causal relationships and applying these criteria to the published knowledge, the field of medicine was dominated by authority-based opinions, expressed by experts (or consensus groups of experts) relying on their education, training, experience, wisdom, prestige, intuition, skill and improvisation. In response, evidence-based medicine (EBM) was developed, to make a conscientious, explicit and judicious use of current best evidence in deciding about the care of individual patients. Now globally embraced, EBM employs a structured, 'transparent' protocol for carrying out a deliberate, objective, unbiased and systematic review of the evidence about a formally framed question. Not only in medicine, but now in dentistry, engineering and other fields that have adapted the methods of EBM, it is the quality of the evidence and the rigor of the analysis through evidence-based logic (EBL), rather than the professional standing of the reviewer, that leads to evidence-based conclusions about what is known. Recent studies have disclosed that toxicologists (individually or in expert groups), not unlike their medical counterparts prior to EBM, show distressing variations in their biases with regard to data selection, data interpretation and data evaluation when performing reviews for causation analyses. Moreover, toxicologists often fail to acknowledge explicitly (particularly in regulatory and policy-making arenas) when shortcomings in the evidence necessitate reliance upon authority-based opinions, rather than evidence-based conclusions (Guzelian PS, Guzelian CP. Authority-based explanation. Science 2004; 303: 1468-69). Accordingly, for answering questions about general and specific causation, we have constructed a framework for evidence-based toxicology (EBT), derived from the accepted principles of EBM and expressed succinctly as three stages, comprising 12 total steps. These are: 1) collecting and evaluating the relevant data (Source, Exposure, Dose, Diagnosis); 2) collecting and evaluating the relevant knowledge (Frame the question, Assemble the relevant (delimited) literature, Assess and critique the literature); and 3) Joining data with knowledge to arrive at a conclusion (General causation--answer to the framed question, Dose-response, Timing, Alternative cause, Coherence). The second of these stages (which amounts to an analysis of general causation), is addressed by an EBM-styled approach (adapted for the infrequent availability of human experimental studies in environmental toxicology). This involves assembling literature (through documented algorithms for database queries), excluding irrelevancies by use of delimiters as filters, and ranking and rating the remaining articles for strength of study design and for quality of execution gauged by application of either a ready-made quality assessment instrument or a custom designed checklist or scale. The results of this systematic review (including a structured review of relevant animal and in vitro studies) are then themselves systematically used to determine which causation criteria are fulfilled. Toxicology is maturing from a derivative science largely devoted to routinized performance and interpretation of safety tests, to a discipline deeply enmeshed in the remarkable advances in biochemistry and molecular biology to better understanding the nature and mechanism of adverse effects caused by chemicals. It is time for toxicologists, like scientists in other fields, to formalize a method for differentiating settled toxicological knowledge of risk from mere nomological possibility, and for communicating their conclusions to other scientists and the public. It is time for EBT.