CAN THERE BE “SIDE EFFECTS” TO USING “THE WRONG IT”? DR. STEFANO DALMIANI – “G. MONASTERIO” FOUNDATION

E-IATROGENESIS, THE DARK SIDE OF E-HEALTH

PLENARY SESSION

10/7/2014 2

“G. Monasterio” Foundation

• 1968: Clinical Physiology Institute – National Research Council

• 1993: National Public Health Service • 2007: Clinical services and research moved

to Monasterio Foundation (FTGM), Tuscany Region healthcare service

Organizational Structure Medical Departments: • Cardiology (Pisa, Massa) • Pneumology (Pisa) • Cardiovascular Medicine (Pisa) • Cardiac surgery (Massa) • Intensive care (Pisa, Massa) • Cath labs (Pisa, Massa) • Outpatient clinic Instrumental Labs: • Chemical labs • Electrophysiology • Electrocardiography • Echocardiography • Radiology • Nuclear medicine, CT-PET, SPECT • Magnetic Resonance (1.5 T, 3 T) • Computerized Tomography Oth. Science: • Exp. Surgery • Epidemiology • Molecular biology • Clinical engineering • Medical Informatics

Research

ICT world in healthcare

• The new world of e-Something, full of endless wonder…

• Lots of benefits without drawbacks? Few things in real world…

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ICT system downsides

• Users: Human being

– Use and misuse, common (bad) habits

– Fully relying on … (technology)

– cognitive “slips”, “human errors”

• Software analysis and development problems

• Electronic devices related issues

7

e-iatrogenesis

• Iatrogenesis refers to any unintended and adverse consequence of well-intended healthcare interventions

• e-iatrogenesis, or technological iatrogenesis, represents the fourth kind of iatrogenesis (clinical, social, cultural)

• “Patient harm caused at least in part by the application of health information technology" (Weiner et al. 2007)

• I am extending “harm” with privacy-related issues

e-iatrogenesis

• Defined in CPOE field, now are spreading all over HIT systems functionalities

• Basically in any healthcare aspects danger exist unobserved and/or unsuspected

• An e-iatrogenic event can be associated with any aspect of a HIT system

• Like any other error, may involve errors of commission or omission

• Root causes of these unintended adverse events may fall into technical, human-machine interface, or organizational domains

e-iatrogenesis

• Some e-iatrogenic events represent the electronic version of “traditional” errors already made on paper, e.g.:

– mistyped order (e.g. illegible handwriting on a paper order)

– Use of outdated information: medical history, clinical parameters, etc

– Use of a wrong patient's EMR

e-iatrogenesis

• Other e-iatrogenic events is related only to HIT systems, e.g.:

– Missing patient information, due to breakdown of patient EMR system

– Choosing wrong drug/dose/delivery from a lengthy drop-down list (most recently Westbrook et al, 2013)

– Distraction caused by alerts (Redwood et al, 2011)

– Prescribing roles restrictions resulting in no treatment or unauthorized treatment (Redwood et al, 2011)

e-iatrogenesis

• More sophisticated events are inducted by lack of something… – Incomplete or outdated clinical decision support system

(CDSS) embedded within an electronic health record might contribute to a clinician’s incorrect diagnosis or treatment plan

– prescriptions based on direct accepting of an automated (proposed) dosage rather than typing the desired dosage

– Use of text template for reporting, jeopardizing a more specific documentation of clinical acts

Nature of the problem

• Researchers have only recently begun to understand extent and nature of this problem, related to: – software engineering: Design technical flaws (in human

interface, system interface, incorrect specifications, different conceptual model among healthcare actors, etc)

– sociotechnical and organizational: Process flaws, local policy

– Human factors: human errors

Software engineering

• Requirements specification, design, development, programming, customization of HIT system

• Software upgrades (including embedded medical knowledge updates), software maintenance activities

• Interactions between software and devices that are being integrated within HIT system

Sociotechnical and Organizational

• Healthcare is defined as a complex sociotechnical system (Aarts J 2012)

• System with poor integration with the sociotechnical aspects of a healthcare organization is equivalent to a poorly designed system

• Local context is important when considering HIT influences on healthcare processes and outcomes – Local/regional/national organizational policies

procedures and processes may influence technology-induced error rates

Sociotechnical and Organizational

• Evaluating the same HIT system: – Unexpected increased mortality after implementation of a

commercially sold CPOE system. (Han YY 2005) – CPOE implementation: no association with increased

mortality rates in an intensive care unit. (Del Beccaro MA 2006)

• Some have suggested organizational decision making influenced the outcomes of these two different implementations.

• Others have suggested that the customization of the technology to a specific patient population may have influenced the outcomes of these studies.

The Human factor

• Distraction error

• Read error, typing error

• Ignored facts, symptoms, signs, guidelines

• Communication error, ambiguity, absence

• Fully relying on HIT systems: Brain “shutdown” effect. – It is belief of some health and HIT professionals that all

HIT is fully tested and safe. So they fully rely on HIT system.

Extension of the problem

• 0.1% of all reports in the United States FDA Manufacturer and User Facility Device Experience (MAUDE) involved HIT (Magrabi et al 2012)

• in Australia, from a voluntary incident database, reported 0.2% of all incidents involved HIT (Magrabi et al 2010)

• 17.1% of all medication incidents involved HIT related technologies such as "computerized prescription order entry", "bar-coded patient identification labels", "infusion pumps", and "computer-aided dispensing labels“ (Samaranayake NR 2012)

• The common feeling is that error rate are under-reported.

Lack of knowledge

• Are physicians aware of such aspects of HIT?

– lack of knowledge of what constitutes a technology-induced error, causing eIatrogenesis

– lack of knowledge about what to report, when to report it and where to report the occurrence of such events (miss, near miss)

Awareness

• develop formalized educational programs in order to:

– generate awareness of this new types of errors

– educate health and HIT professionals about where to report such errors, so that their types and rates of occurrence can be effectively monitored and critical errors (i.e., those involving harm and death) can be addressed

How to reduce and prevent eIatrogenesis

• proactive method

– used to identify potential causes of technology-induced error prior to their occurring

• reactive method

– occurring after an error has taken place, in an effort to prevent future errors and stimulate learning

(Borycki and Keay 2010)

How to reduce and prevent eIatrogenesis

• Heuristic evaluation – involves identifying problems in the design of a system.

In heuristic evaluation an evaluator examines the interface and determines if it is in keeping with recognized safety heuristics.

• Cognitive walkthrough – is a usability inspection method which involves one or

more analysts “stepping through” or “walking through” a user interface or system to identify: user goals, user actions, system responses and potential user problems

How to reduce and prevent eIatrogenesis

• Usability testing – is a method for assessing usability by observing

representative users of a system performing representative tasks using the system. It may involve video recording users and asking them to “think aloud” while carrying out tasks while using the system.

• Clinical simulations – involves extending usability testing to include observing

representative users carrying out representative tasks in highly realistic and representative settings and contexts (e.g., in simulated operating rooms or hospital rooms), more realistic than Usability testing.

How to reduce and prevent eIatrogenesis

• Computer based simulation – use computers to imitate real-world processes for the

purposes of developing a better understanding of a safety problem or forecasting the effects of safety issues.

• Case study – used to analyze persons, events, projects, organizations

and healthcare systems in healthcare. It employ several methodological approaches, including: reviews of computer log data, expert review of software and interviews with individuals involved in the incident where a eIatrogenic error has occurred

How to reduce and prevent eIatrogenesis

• Ethnography – is the study and systematic recording of data about

health and health informatics culture – often involves interviews, focus groups and observation.

• Rapid assessment process (RAP) – is an ethnographic, but RAP employs several methods in

order to speed the data collection (video, voice recording, etc).

– RAP employs the use of teams, subject of observation. The focus of the research is narrow and problem oriented (such as focusing on HIT safety).

Proactive vs Reactive

Proactive vs Reactive

• In Proactive method the benefits are significant. eIatrogenic errors can be prevented before they have a chance to occur if they can be predicted and rectified before widespread system release. The costs associated with addressing these errors are significantly lower as changes can be made to the HIT before implementation. It is a cost reduction strategy for HIT system development.

• Reactive method are always used in incident analysis after miss or near-miss events

Proactive vs Reactive

• The proactive method allow vendors and healthcare organizations (local, regional, national health authorities) to "prune off" potential eIatrogenic errors before they occur and to prevent any future occurrence of such errors.

• The proactive and reactive methods includes policy and organizational changes that involves some effects in HIT systems evolution

Devices

• Are we always using the right devices (HW+SW) in every clinical setting?

Mobile Devices

• App marketplace includes thousands medical application. Are they Medical Devices? Should they run on Medical Devices?

Software Medical Device in EU • EN 60601-1 Sec. 14 (SW Design and integration)

• ISO 13485 Design Control (Quality mgmt. sys.)

• EN 60601-1-6 SW Usability (UI)

“If you’re not paying, you’re the product”

Disclaimer: Instant Blood Pressure is for entertainment purposes only. It is not an FDA cleared medical device. Consult a doctor if you have any health concern

http://www.imedicalapps.com/2014/07/iphone-health-app-patient-harm/

$ 3,99

Marketing and disclaimers

Infective risk – BYOD issues

Risk analysis and management

A residual risk will always exist

Where do we go?

• To reduce medical error (iatrogenesis) use CPOE (Kaushal R et Al. 2003)

• To avoid HIT error (eIatrogenesis) avoid CPOE (Han YY 2005)

Where do we go?

• We should take into account the positive, neutral, and harmful consequences of introducing a HIT system

• we also need to understand how technology use can improve healthcare as well as detract from healthcare work globally (Borycki EM et al. 2010)

Conclusions

• “health informatics and patient safety/quality communities must urgently collaborate to addresses this emerging problem” (JP Weiner)

• well-designed HIT module used appropriately may also contribute to an undesirable outcome, just like a common treatment plan could be ineffective

Conclusions

• We should move towards an integrative cognitive-socio-technical approach in health informatics: analyzing technology-induced error involving health information systems to improve patient safety

Conclusions

• Should HIT systems be documented and “administered” like drugs?

May cause Wrong Prescription

May cause Patient sudden death

WATCH CAREFULLY DATA BEFORE

SAVING

THIS IS NOT A TOY

THANK YOU S. DALMIANI DALMIANI@FTGM.IT