Scot M. Silverstein, MDDrexel University, College of Information Science and Technology, Philadelphia, PAsms88@drexel.edu

Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data onUnintended Consequences of Healthcare ITAbstract:

Background: Case reports, systematic statistical data and other information on unintendedconsequences (UC’s) of healthcare information technology (HIT) is relatively scarce despiteample literature on potential HIT benefits. This impedes optimal efforts at computerization of healthcare, and can and should be remediated.Objectives: To illustrate the relative scarcity of information on HIT UC’s, suggest contributingfactors, and recommend tactical measures for improvement such as better user reporting of HITUC’s and better diffusion of existing literature on the phenomenon.Methods: A number of recent indicators for scarcity of UC information were compiled and possible reasons described. Examples of suboptimal adverse results disclosures in relateddomains (e.g., the pharmaceutical industry) that may hold lessons for HIT were included.Results: UC information on HIT is relatively scarce likely due to a variety of influences andcomplex interactions among and between medicine, informatics, government and industry that,left unaddressed, may lead to delays or other harm to good faith efforts to computerizeinformational aspects of healthcare delivery and research.Conclusions: The relative scarcity of definitive information on the extent of HIT UC’s should beaddressed in a responsible and ethical manner by clinicians, regulators and other stakeholders if this technology is to be successfully rolled out nationally.

Keywords:

Medical Records Systems, ComputerizedComputer Systems EvaluationMedical Errors

“Most especially must I tread with care in matters of life and death.”

Hippocratic Oath, ModernVersion [1]

“ICT (Information and communications technology) use leads to multiple, and often paradoxical, effects.”

Kling, Sawyer and Rosenbaum, Understanding Social Informatics [2]

1. Background

Medical error reduction is an international issue, as is the implementation of healthcareinformation technology (HIT) as a potential means of achieving it. Biomedical informaticsresearchers have encountered numerous instances in which HIT applications such as EHR,CPOE and CDSS seem to facilitate errors rather than reduce their likelihood. With a heightenedawareness of these issues, informaticians can facilitate better system design, implementation, andresearch in such a way that might help avoid or minimize avoid unintended consequences of these errors. [3]Unintended consequences (UC’s) are outcomes of actions that are not originally intended in a particular situation. In the clinical domain, UC’s, including those related to the use of healthcareIT (HIT) are usually equated with clinical side effects or adverse medical events and poor outcomes. [4]Information systems are not intended to disrupt clinicians’ workflow, cognitive processes or actions, so HIT-related “close calls” or “near misses” might also be considered as HIT UC’s.These are clinician errors of commission or omission related to unintended HIT malfunction,cognitive or work disruption, and other issues that do not result in patient harm due toredundancies and human checks and balances in the healthcare delivery process that correct for the error before harm occurs.UC case reports, rates, statistics and other information (henceforth “UC information”) aresystematically reported by manufacturer and specific product, and are available in many domainssuch as drug adverse events and automobile defects. When, however, information is needed onthe incidence of UC’s related to HIT applications such as electronic health record (EHR) systemsor computerized order entry (CPOE) systems, buyers largely need to rely on the vendorsthemselves with their inherent conflict of interest, on word of mouth, anecdote, and perhapsscant peer reviewed literature. There is no systematic, comprehensive, trustworthy source of UCinformation, especially if the information is sought about a specific HIT product version or useof a product in specialized clinical settings such as subspecialty units. UC’s could be minor andlimited, or could be widespread and clinically significant. It is difficult for applied informatics personnel and others involved in HIT selection and implementation to ascertain the overall UCincidence nationwide – or worldwide - without good data.

While there is an abundance of literature on the positive attributes of HIT towards improvinghealthcare quality, efficiency, cost effectiveness and other issues in specific clinical settings,there is an apparent scarcity of data on

in situ

UC’s related to HIT. Safety is unproven byimpartial, methodological study and the true risk/benefit ratio is unknown.

2. Methods

A number of recent indicators for scarcity of UC information were compiled and possiblereasons described. Examples of suboptimal adverse results disclosures in related domains (e.g.,the pharmaceutical industry) that may hold lessons for HIT were included. A number of tacticsfor remediation of HIT UC information scarcity are suggested that are practicable at the level of the individual researcher and clinician, as well as at the policy-making level.

3. Results3.1 Recent indicators of scarcity of detailed, comprehensive UC information in HIT

UC information diffusion (as well as other information that could place HIT in a negative lightsuch as implementation conflicts and failures) seems muted. Published information appearsspotty compared to other technological domains and detailed, comprehensive statistics and casedetail appear uncommon.HIT is an unregulated industry. There are no federal databases to turn to regarding HIT UC’s,nor is there a commercial source of comprehensive information.The Joint Commission recently reported in a Sentinel Events Alert

[5]

that “as healthinformation technology (HIT) and converging technologies—the interrelationship betweenmedical devices and HIT—are increasingly adopted by health care organizations, users must bemindful of the safety risks and preventable adverse events that these implementations can createor perpetuate …

There is a dearth of data on the incidence of adverse events directly causedby HIT overall

(emphasis mine).

The Joint Commission did state that there was some known data on HIT adverse events relatedspecifically to pharmaceuticals. The JC reported that the United States PharmacopeiaMEDMARX database [6] included 176,409 medication error records for 2006, of which 1.25 percent resulted in harm. Of those medication error records, 43,372, or approximately 25 percent,involved some aspect of computer technology such as information management systems,confusing displays and software. Lack of other sources of HIT UC information, however, led tothe overall statement about a dearth of data.A longitudinal citation analysis conducted across a significant portion of the Medical Informatics periodical literature from 1994-2005, focusing on the identification of strings (linear citation patterns) and networks (multi- branched citation patterns) of highly cited MI-related articlesindexed in the Web of Science, demonstrated an interesting pattern. The temporal strings are