Wednesday, April 21, 2010

HE-75: Collecting Data and Modeling Tasks and Environment

This article expounds on my earlier article related to AAMI HE-75: Know what thy user does and where they do it. 


Collect and Represent the Data


Ideally the first steps in the design process should occur before a design is ever considered.  Unfortunately, in virtually every case I have encountered, a design for the user interface has already been in the works before the steps for collecting user and task related data have been performed.


Nevertheless, if you are one of the people performing the research, do as much as you can to push the design out of your mind and focus on objectively collecting and evaluating the data.  And, in your data analysis, following the data and not your or the preconceived notions of someone else.


There are a variety of means for collecting data and representing it.  The means for collecting the data will generally involve:
  • Observation - collecting the step-by-step activities as a person under observation performs their tasks.
  • Inquiry - collecting data about the a person's cognitive processes.
Once the data has been connected, it requires analysis and representation in a manner that is useful for later steps in the design process.  Data representations can include:
  • Task models - summary process models (with variants and edge cases) of how users perform each task.  This is different from workflow models in that in task models no references to specific tools or systems should be included in the task model.  A task model should be abstracted and represented at a level without reference to actions taking place on a particular device or system.
  • Workflows - summary process models (with variants and edge cases) similar to the task flows with reference to a particular device or system.  For example, if the user interface consists of a particular web page, there should be a reference to that webpage and the action(s) that took place.
  • Cognitive models - a representation of the cognitive activities and processes that take place as the person performs a task.
  • Breadth analysis - I have noted that this is often overlooked.  Breadth analysis organizes the tasks by frequency of use and if appropriate, order of execution.  This is also the place to represent the tasks that users perform in their work environment but were not directly part of the data collection process.
Detailed Instructions


I cannot hope to provide detailed instructions in this blog.  However, I can provide a few pointers. There published works on how to collect, analyze and model the data by leaders in the field.

Here are three books that can recommend and several can be found in my library:


User and Task Analysis for Interface Design by  J. Hackos & J. Redish


I highly recommend this book.  I use it frequently.  For those of us experienced in the profession and with task and user analysis, what they discuss will seem familiar - as well it should.  However, what they do are provide clear paths and methods for collecting data from users.  The book is well-structured and extremely useful for practitioners.  I had been using task and user analysis for a decade before this book came out.  I found that by owning this book, I could throw all my notes away related to task and user analysis, and use this book as my reference.


Motion and Time Study: Improving Work Methods and Management 
by F. Meyer
Motion and Time Study for Lean Manufacturing (3rd Edition) by F. Meyer & J. R. Stewart


Time and motion study is a core part of industrial engineering as the means to improve the manufacturing process.  Historically, time and motion studies go back to Fredrick Taylor (http://en.wikipedia.org/wiki/Frederick_Winslow_Taylor) who pioneered this work in the later part of the 19th and in early part of the 20th Century.  I have used time and motion studies as a means for uncovering problematic designs.  Time and motion studies can be particularly useful when users are engaged in repetitive activities and as a means for improving efficiency and even as a means for reducing repeated stress injuries.  The first book I have in my library however it is a bit old (but very inexpensive) so I include the second book by Meyers (and Stewart) that more recent.  I can say that the methods of time and motion can be considered timeless, thus adding a book published in 1992 can still be valuable.

Time and motion studies can produce significant detail regarding the activities that those under observation perform.  However, these studies are time-consuming and as such, expensive.  Nevertheless, they can provide extremely valuable data that can uncover problems and improve efficiency.


Contextual Design: Defining Customer-Centered Systems (Interactive Technologies) by H. Beyer & K. Holtzblatt &

Rapid Contextual Design: A How-to Guide to Key Techniques for User-Centered Design (Interactive Technologies) by K. Holtzblatt, J. B. Wendell & S. Wood


The first book I have in my library, but not the second.  I have used many of the methods described in Contextual Design before the book was published.  The contextual design process is one of the currently "hot" methods collecting user and task data, and as such, every practitioner should own a copy of this book - at least as a reference.


I believe what's particularly useful about this contextual inquiry is that it collects data about activities not directly observered.  It's able but that affect the users and the tasks that they perform.  For example, clinicians engaged in the remote monitoring of patients often have other duties, many of them patient related.  Collecting data exclusively targeting remote monitoring activities (or the activities specific to a targeted device or company) can miss significant activities that impact remote monitoring and vice versa


Additional Resources


As a graduate student, I had the privilege of having my education supported by Xerox's Palo Alto Research Center.  I was able to work with luminaries of the profession, Tom Moran and Allen Newell on a couple of projects.  In addition I was able to learn the GOMS model.  I have found this model useful in that it nicely blends objectively observed activities with cognitive processes.  However, the modeling process can be arduous, and as such, expensive.  

Allen Newell and Herbert Simon are particularly well known for their research on chess masters and problem solving.  They were well-known for their research method, protocol analysis. Protocol analysis is a method that has the person under observation verbally express their thoughts while engaged a particular activity.  This enables the observer to collect data about the subject's thoughts, strategies and goals.  This methodology has been adopted by the authors of contextual inquiry and one that I have often used in my research.


The problem with protocol analysis is that it cannot capture cognitive processes that occur beyond the level of consciousness, such as the perception.  For example, subjects are unable to express how they perceive and identify words, or express how they are able to read sentences.  These processes are largely automatic and thus not available to conscious processes.  (I shall discuss methods that will enable one to collect data that involves automatic processes when I discuss usability testing in a later article.)  However, protocol analysis can provide valuable data regarding a subject's thoughts particularly when that person reaches a point where confusion sets-in or where the person attempts to correct an error condition.

Here's a link from Wikipedia: http://en.wikipedia.org/wiki/GOMS.


Another book that I have in my library by a former Bell Labs human factors researcher, Thomas K. (TK) Landauer, is The Trouble with Computers: Usefulness, Usability, and Productivity.


This is fun book.  I think it's much more instructive to the professional than Don Norman's book, The Psychology Of Everyday Things.  (Nevertheless, I place the link to Amazon just the same.  This is a good book for professional in the field to give to family members who ask "what do you do for a living?")  

Tom rails against the many of the pressures and processes that push products, systems and services into the commercial space before they're ready from a human engineering standpoint.  Although the book is relatively old, many of the points he makes are more relevant today than when the book was first published.  The impluse to design user interfaces without reference or regard for users has been clearly noted by the FDA, hence the need for HE-75.

Monday, April 19, 2010

Market Research Report Available: Remote & Wireless Patient Monitoring Markets

A new market research report has just been made available that discusses the market and investment potential of remote and wireless monitoring of patients.  I do not endorse this study or suggest it's purchase.  I am making it's existence known.

Here's a list of some of disorders covered by the study:
  • Asthma
  • COPD
  • CHF
  • CHD 
  • Diabetes 
Here are a few quotes from the press release:


Patient monitoring systems are emerging in response to increased healthcare needs of an aging population, new wireless technologies, better video and monitoring technologies, decreasing healthcare resources, an emphasis on reducing hospital days, and proven cost-effectiveness.
Of these new high-tech patient monitoring systems, nearly all focus on some form of wireless or remote patient monitoring. ...
...  the following companies are profiled in detail in this report:
  • Abbott Laboratories, Inc
  • Aerotel Medical Systems
  • GE Healthcare
  • Honeywell HomMed LLC
  • Intel Corporation
  • Philips Medical Systems
  • Roche Diagnostics Corporation

Here's the link to the press release and links to purchasing this study: http://www.marketresearch.com/product/display.asp?productid=2645944&g=1

 

Saturday, April 17, 2010

Article: Investments in Real Time Medical Monitoring

This is an article targeted to the investment community regarding investment in real time medical monitoring.  I do not endorse anything in this article.  However I do find it interesting.  I do not know the track record of this publication.  Nevertheless, here a link to the article: http://www.onemedplace.com/blog/archives/4878

Article: Initiation of a Telemonitoring Study of Heart Failure, COPD and Diabetes Patients

A study will be performed by researchers from Case Western Reserve University and Cleveland State University with patients suffering from heart failure, diabetes and COPD.  The objective of the study will be to determine how effective remote monitoring is with maintaining the health of these patients and with keeping them out of the hospital.

Here's a link to a report on this study: http://www.physorg.com/news190634143.html 

Additional Resources

COPD 

 The Complete Guide to Understanding and Living with COPD: From A COPDer's Perspective 

COPD For Dummies 

Diabetes

Diabetes For Dummies (For Dummies (Health & Fitness)) 

Tell Me What to Eat If I Have Diabetes: Nutrition You Can Live With 

The Official Pocket Guide to Diabetic Exchanges 

Heart Failure

The Cleveland Clinic Guide to Heart Failure (Cleveland Clinic Guides)


Manual of Heart Failure Management

Friday, April 16, 2010

Medtronic Remote Monitoring Study: CONNECT

At the American College of Cardiology 59th annual conference George H. Crossley, MD presented evidence that cardiac patient from remote monitoring (one scheduled in-office visit per year with remote monitoring) verses standard in-office care (four in-office visits per year) cuts the time between the time a cardiac or device related event occurs and when a treatment decision is made.

The title of the study: "The clinical evaluation of the remote notification to reduce time to clinical decision (CONNECT) Trial: The value of remote monitoring."

I present a summary of the method and the results of the study gleaned from the slides presented by Dr. Crossley at the conference.

Hypothesis

Tested hypothesis: Remote monitoring with automatic clinician notifications reduces the time from a cardiac or device event to a clinical decision.

Additionally investigated were rates utilization of the health care system including hospitalization and between treatment groups.

Method

Study participants:  1997 newly implanted CRT-D and DR-ICD patients from 136 US centers were randomly assigned to one of two groups. The first group had 1014 patients assigned to the remotely monitored group and the second had 983 patients assigned to the standard in-office care group. The patients were reasonably well matched for age and gender characteristics.  (A procedure similar to the Biotronik TRUST studies.)

The patients were followed for 12 months.  (On first reading, I found the the time relatively short in that I would not expect enough differentiating events would occur during that time.  However, on further reading, I believe my first impression was incorrect.)

Findings

Time from Event to Clinical Decision

The median time (used nonparametric inferential statistics for the analysis) from the cardiac or device event to clinical decision was 4.6 days in the remote group and 22 days in the in office group. This difference was significant.  The remote group involved 172 patient while the in-office group involved 145 patients.

The cardiac/device events included:
  • Atrial Tachycardia/Fibrillation (AT/AF) for 12 hours or more
  • Fast Ventricular rate. Of at least 120 beats per minute during at least a 6 hour AT/AFT event
  • At least two shocks delivered in an episode
  • Lead impedance out of range
  • All therapies in a specific zone were exhausted for an episode
  • Ventricular Fibrillation detection/therapy off
  • Low battery
Total number of events Remote group: 575 and In-office group: 391.  The slides show the breakdowns.

Office Visits

The number of office visits per patient reported are shown below.
                        Scheduled     Unscheduled      All office
Remote group:     1.68              2.24              3.92
In-office group:    4.33              1.94              6.27

The TRUST studies showed a slight increase of more unscheduled visits for the remote group. However, given the nature of the study and that remotely monitored patients would receive only one in-office visit per year, it's remarkable how similar the numbers between the two groups are.

Utilization of the Health Care System

Number of incidents where patients used the health care system show virtually no difference, hospitalization or emergency room. 

However, a remarkable difference was the significant difference in length of stay when there was a hospitalization. The remote group had a mean hospital stay of 3.3 days while the in-office group was 4.0 days with an estimated savings per hospitalization of $1659.

Conclusion

The CONNECT and (Biotronik) TRUST studies show clear benefits from a number of standpoints for remote monitoring.  In addition, the CONNECT study showed clear cost and hospital resource utilization benefits from remote monitoring in that hospitalized patients had shorter stays indicating that they were in better shape than patients in the in-office group when admitted to the hospital.  Quick responses seem to lead to better outcomes as well as cost reductions.


Reader Article: Controlling Glucose Level to Prevent Diabetes

 Here's something I have been wishing for ... a guest article authored by one of my readers.  If you have something that you would want me to publish in this blog, by all means, please send it and if I think it has technical merit and seems appropriate, I shall publish it.  


This article is written by Kristina Ridley who writes for the diabetes blood glucose  blog. (http://www.diabetesmeters.org/)This is her personal hobby-blog that focuses on healthy eating and tips to measure blood glucose levels at home to help people understand early diabetes symptoms.  

This article may have bearing on remote monitoring technology for diabetes in the what people consume has likely impact on glucose and insulin levels.  I know that heart failure patients (whom I understand are often diabetic) can remotely report to caregivers their weight, blood pressures, etc.  I would seem reasonable that diabetics could report their food and fluids intake for remote monitoring by their caregivers. 

I am particularly interested in Kristina's last section, "Too Much Control."  My experience in cardiac rhythm management suggest close monitoring and control are strong positives.  I hope that Kristina or someone else could write a rejoinder to this section.


Here is Kristina's unedited article:

Here’s a Quick Way to Control Glucose Level to Prevent Diabetes
 

Our pancreas is affected by diabetes – specifically, Type 2.Our body contains glucose found in the blood stream, which it gets from the sugar in food. Our body uses the glucose, but only when it goes into our blood cells and the insulin released by our pancreas converts it. Insulin production and utilization is difficult for someone who lives with Type 2 diabetes. There is a lot of glucose in the body, but your cells cannot locate them.

The American Diabetes Association has become very important when it comes to gathering critical information about this medical condition. With approximately 23.6 million citizens living with diabetes, America is an extremely unhealthy country. Over 90% of all patients with diabetes have Type 2.Most diabetics tend to be overweight and have relatives with the same condition. Too much glucose can cause serious, irreparable damage to internal organs and to the overall nervous system.

Diabetes and Your Life

If you have Type 2 diabetes, you need to live in a healthy manner. Living healthy and engaging in healthy practices will affect you tremendously. Two common examples of healthy routines include exercising and consuming healthy foods. Making sure that your glucose levels stay in the recommended range translates into being able to avoid complications in your health. A finger prick test is a common and reliable way to monitor your body’s blood glucose levels. 
 
This test, according to physicians, is sufficient enough for glucose monitoring like the HbA1c test. The amount of glycated hemoglobin in your blood is determined by this HbA1c test, aside from it alerting you if you reach a high glucose level. Results of these A1c tests show that people with diabetes are at a seven percent level. The CDC reports that if one maintains their a1c levels at seven percent, they could reduce the possibility of risks as high up as forty percent.

Too Much Control 

Recently, there have been medical studies that seem to indicate that maintaining A1c levels below 7% may be a bad idea after all. One of these studies, conducted at the Lancet and Swedish Medical Center in Seattle, has found that people who have median levels may be at a far greater risk of death, especially for those taking insulin. However, other tests have indicated that A1c levels of 7 percent is still perfectly healthy. Matt Davies, An accredited Endocrinologist, has stated that maintaining a 7% A1c level is healthy according to recent studies, but that physicians should always take the individual patient's history into account prior to planning treatment.
 

Kristina provides diabetic recipes in here blog.  In addition, I have provided a link to Amazon that will initiate a search for diabetic cookbooks.
Search Amazon.com for diabetic cookbook

Why the Moniker "RemoteProgrammerGuru?"

For those who have wondered ... there is a story behind why I use the moniker, "RemoteProgrammerGuru."  Any identity that has as part of the name, "guru" could be considered more than a little ostentations.  Here's the definition as provided by Wikipedia:http://en.wikipedia.org/wiki/Guru.

The definition describes someone with "supreme knowledge."  Fortunately for me, the term in India is synomous with "teacher."  For me, the "term" teacher was more appropriate and the role of a teacher came as a surprise.

I was part of a project where remote programming was the technical centerpiece of a proposed solution.  Frankly, I was new to remote programming for medical devices ... as are most.  However, I have a rich telecommunications background including expertise in wireless communications.  (I was the principal investigator on two federally funded telecommunications research grants.)  I know the technologies and I know how things work. 

As it turned out, I knew more about telecommunications than my colleagues who had been working in remote programming for longer than I ... much more.  And I started teaching them, about communications and about remote programming and necessary processes to insure communication integrity.  In effect, I became a "guru," a teacher.

Finally, since remote programming when designed and implimented correctly, involves sophisticated monitoring, I decided to incorporate the term "remote programmer" to represent someone who informs people about remote monitoring and programming.  Thus the moniker, "RemoteProgrammerGuru" was created.

Friday, April 9, 2010

Announcement: Biotronik has MRI Conditional Pacemaker Approved in Europe

Announcement that Biotronik has gained European approval for an MRI conditional pacemaker and leads.  Here's a link to the announcement from Business Wire:
http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20100407006972&newsLang=en

I have worked on the usability issues related to providing MRI conditional pacemakers and leads.  Without disclosing too much, my work related to MRI conditional pacemakers and leads got me interested in remote monitoring and remote programming.  So, for me there's a link between MRI conditional pacemakers and leads, and remote monitoring and programming.

Article: Updates to the Development of Medical Body Area Networks (MBANS)

Mobihealth News has published an article indicating that Philips is interested in a 10MHz spectrum dedicated to MBANS.  Here's the link to the article:
http://mobihealthnews.com/7178/philips-suggests-dedicated-mhealth-spectrum/

Mobihealth suggests that Philips is taking a different approach to MBANs than GE who wants 40Mhz of spectrum dedicated to MBANs.  The GE is interested in MBANs that would be used in hospitals.  Philips is interested in the deployment of MBANs to the field, and that Philips would produce consumer and not medical grade products.  I am not sure how this could work in the US.  However, this development is worth continuing attention.

Article: Wireless Remote Monitoring Prevents Complications of Chronic Diseases

An interesting article about the benefits of remote monitoring in the care of patients with chronic diseases from the Press of Atlantic City, 8 March 2010.  Here's the link to the article:  http://www.pressofatlanticcity.com/life/monday_health/article_1333e585-e3a6-5ba8-a411-75530f6b63cf.html

Quotes from the article:
Improving management
By early 2012, Americans will use about 15 million wireless health-monitoring devices, according to a forecast from ABI Research, which tracks mobile-technology trends. The mobile health market is projected to more than triple to $9.6 billion in 2012 from $2.7 billion in 2007, according to study from Kalorama Information Inc
[T]he first pilot project in the nation to assess whether the use of remote digital devices with data sent over the Internet to a doctor's office improved management of multiple chronic diseases - diabetes, heart disease and high blood pressure, also known as hypertension. 
Diabetics and hypertensive patients increased the number of days between appointments by 71 percent and 26 percent respectively ...
"One of the great promises of wireless (health) is making it a part of the patient's daily life, not an interruption to what they're doing every day," ...
From personal experience I believe the last sentence I quoted is among the most important in the article.  The entire process should be so smooth, so automated, so uncomplicated and unintrusive that the patient's life is uninterrupted and that the data is seamlessly collected and sent to the patient's caregiver.

Two other items to note.  The first is a brief discussion of the sensors connected to the patient's body.  They mention band-aid size electrodes.  I am not sure if these are the "digital plaster" that I've discussed in an earlier article.  http://medicalremoteprogramming.blogspot.com/2009/11/digital-plaster.html
Or something else.  I do not know, but it would be interesting to find out.  If I have any informational, I'll post it.  If you have any information, please enlighten us with a comment.

The second issue of note is the discussion in the article regarding payment, and who will do it.  Given the convoluted nature of our system of payments, this will be the most difficult issue to resolve, I believe.  It's ironic considering that remote monitoring saves money.   I think the technical issues will be minor in comparison.  I hope I am proved wrong.