Our Cancer Journey Week 18

On Friday, after careful consideration, the BIDMC oncologists elected not to treat Kathy because her side effects from Paclitaxel (Taxol)  were so severe - increasing pain and numbness in her hands and feet.   She cannot hold a pencil, use a paintbrush, or eat with chopsticks.   She has to nap mid day because of fatigue caused by constant neuropathic pain.   Thus far, the Vitamin B6 has not helped and her clinicians recommended Gabapentin (Neurontin) to reduce the discomfort.   She's not enthusiastic about masking symptoms.   She'd prefer to monitor her body's progress objectively.

Kathy's attitude toward cancer treatment is aggressive - "poison me today for a cure tomorrow".  She can accept short term pain for long term gain.  The problem with neuropathy is that it may be permanent.    She admits that permanent loss of her ability to create art or feel the difference between silk and sandpaper is challenging to accept.

Tomorrow, her clinicians will evaluate her progress and consider several options:
*Stop chemotherapy and await the results of the April 25 imaging studies.  She may already be treated sufficiently
*Continue chemotherapy with an agent similar to Paclitaxel called Docetaxel (Taxotere)  
*Stop the entire class of Taxane therapies and return to a cycle of Adriamycin/Cytoxan since that seemed to work so well in her early therapy

There are many possibilities and we're confident that all will be well.

Last Saturday we visited the Erikson Grain Mill, a family operated supplier of feeds for chickens, horses, and other farm animals.  As luck would have it, a customer just cancelled their order for six Araucana/Ameraucana chicks (photo above).   Moments after we arrived another family offered to adopt them, but we had already made up our minds.   On Saturday at 2pm we became chicken farmers.   Our young hens are enjoying the warmth and security of their new brooder (a Rubbermaid 37 gallon storage container), infrared lamp, and feeder.    While at Erikson's we ordered the remainder of our 2012 coop population - 2 Buff Orpingtons, 2 Brahmas, and 2 Jersey Giants.

There's one other addition to our property that will begin life in our coop but then free range - Guinea Fowl.   I've had Lyme disease twice and the Guinea Fowl are well known tick eaters.    They'll start in our brooder for 6 weeks, live in the coop for 6 additional weeks, then we'll let them free range over our 15 acres, training them to return to the coop at night for safety.

Although Kathy's hands and feet are numb, she's very capable of caring for the new additions to our lives.   Our move preparations are nearly complete so she can turn her attention to our next life phase.  It's much more enjoyable to design the ideal coop for a  small flock of chickens than to focus on the short term disability caused by cancer treatment.   There are even a few chick brooder engineering problems for me to solve.   More about that in tomorrow's post.

The April HIT Standards Committee

The April HIT Standards Committee included a comprehensive review of the Standards & Certification Criteria Notice of Proposed Rulemaking (NPRM) by each workgroup/task force/power team during a 5 hour marathon session.   The capstone of the meeting with a thematic review of the entire NPRM by the Patient Engagement Power Team.

The meeting began with a "chapter and verse" review of each NPRM standard.

Here are the section by section highlights of our discussion:

§ 170.314(b)(3) E-prescribing
The NPRM requires NCPDP Script 10.6 for content and RxNorm as the vocabulary.  We also recommended that HL7 2.x be allowed for the highly constrained use case of pharmacies located within a hospital as part of an organized healthcare arrangement, since such interfaces are widely implemented today.

§ 170.314(b)(3) Demographics
The NPRM requires OMB standards for race and ethnicity, ISO 639-1 subset of 639-2 for language and ICD10 (not ICD10-CM) for Cause of Death, which has been used by government to code cause of death since since 1999.   We noted that ICD-10 CM has been delayed and recommended it be removed entirely from the NPRM.    We recommended that the HIT Policy Committee consider the use of ISO 3166-2 if country of birth is a desirable data element.   We also considered the use of a more granular race/ethnicity code set such as CDC, but deferred this to the next edition of Meaningful Use.

§  170.314(a)(4) Vital Signs and other observations
The NPRM does not require any standards in this area currently.   We referred to the September 2011 vocabulary and code sets recommendations and suggested that ONC specify LOINC for specific study name, SNOMED-CT for appropriate findings, and UCUM for specific units of measure for all structured observations including vital signs.  We also suggested that patient experience, such as pain scales, be recorded using LOINC for assessment instruments and SNOMED-CT for appropriate responses.

§  170.314(a)(5) Problem Lists
The NPRM requires SNOMED-CT for problem lists.  We recommended that the HIT Policy Committee consider the use of a field that represents an administrative categorization of the visit/billing diagnosis to support secondary uses of data but did not make a specific standards recommendation.

§  170.314(a)(8) Clinical Decision Support
The NPRM specifies the use of the "Infobutton" standard.   We recognize that clinical decision support includes access to educational materials, alerts, and reminders.   We felt that a functional description of capabilities rather than a specific standards requirement would best achieve the policy goals.   We made "Infobutton" optional, not a certification criteria, to encourage its adoption but also enable innovation.

§  170.314(a)(17) Electronic Medication Administration Record
The NPRM does not constrain the technological approach to ensuring the right medication is given to the right patient via the right route at the right dose at the right time.  The NPRM specifies the use of NTP to synchronize clocks.   We agree that the technology for EMAR should not be over specified, enabling innovation.

§  170.314(e)(2) Clinical Summmaries
The NPRM specifies the use of Consolidated CDA and several vocabularies (OMB Race/Ethnicity, ISO 639-1 subset of ISO-639-2 for language, SNOMED-CT for problems, LOINC for labs, and RxNorm for medications).   We recommended that ICD-10 PCS be replaced with SNOMED-CT for procedures, completing our recommendation to remove ICD-10 CM and ICD-10 PCS entirely from the NPRM.

§  170.314(a)(14) Patient Lists
The NPRM provides a functional description of capabilities rather than a standard for the generation of lists of patients matching specific clinical criteria.   We noted that no current standard exists to transmit lists of patients in batch to registries and repositories, although this is desirable for the next edition of Meaningful Use.

§  170.314(a)(16) Patient Education
The NPRM requires Infobutton.   As with Decision Support, we recommended that Infobutton be an optional standard, not required for certification.

§  170.314(b)(1) and § 170.314(b)(2) Transition of Care Summaries
The NPRM specifies the use of Consolidated CDA and several vocabularies (OMB Race/Ethnicity, ISO 639-1 subset of ISO-639-2 for language, SNOMED-CT for problems, LOINC for labs, and RxNorm for medications).   It also recommends the use of the Direct implementation guide, XDR/XDM, and optionally SOAP for transport.   We had a robust discussion about the parsimonious approach to transport.    We concluded that the best approach would be to require the Direct implementation guide and encourage the use of XDR/transport standards of NwHIN Exchange by listing XDR and the S&I Framework Implementation Guide for NwHIN Exchange transport as optional, not certification criteria.   This was truly an achievement - we succeeded in specifying one transport standard requirement for every EHR.  Wes Rishel made an important point about the need to support "bilateral asynchronous upgrades" - the notion that different versions of transport Implementation Guides might be used over time by senders and receivers.   We have to be very careful to ensure backward compatibility as our transport standards evolve.

For the remaining NPRM sections, we worked by the principle of consent unless otherwise noted by standards committee members.

§  170.314(e)(1) View, download, and transmit to 3rd party.
We recommended that patient download capability be required to use Consolidated CDA as a minimum.  We noted that TLS is an example of a means to secure the transmission channel but also recognized other approaches are possible.   We recommended functional criteria for securing endpoints rather than a named standard.

§  170.314(d)(2)  Auditable events and tamper-resistance.
We noted redundancy in the NPRM - audit logs cannot be modified, but there is a need to detect modification.  We also recommended that ASTM E2147 be used as a list of audit log data elements.

§  170.314(a)(13) Family History
The NPRM does not require a specific standard.  We concur that no standard is widely implemented today, although the Surgeon General's XML for family history has been used more than the HL7 pedigree standards.

§  170.314(f)(7) and § 170.314(f)(8) Cancer Registry Reporting
We noted that the CDA Cancer Registry standard is not deployed in production.   We also noted that this refers to a menu set item, so it is not a general requirement of EHR certification. It is a reasonable early standard for oncology specific EHRs.

§  170.314(c)(1)-(3) NQF Quality Data Model
We noted that additional work on the Quality Data Model will be needed to ensure it aligns with all the other recommendations we made at today's meeting.    We also noted that QRDA Category II and III are not yet balloted standards.

The Standards Committee reaffirmed its acceptance of all these recommendations by consensus.   A remarkable achievement.

Leslie Kelly Hall then presented the guiding principles of the Consumer/Patient Engagement Power Team, a truly remarkable body of work assembled in very limited time.

Our next process step is to draft and review a final transmittal letter to ONC, which we'll do over the next few weeks.

The HIT Standards Committee is such an effective group with amazing expertise and camaraderie that today's meeting was a perfect storm moment.   This is definitely a time we'll all be telling our grandchildren about.

Brainstorming about a Collaborative Data Center

Meg Aranow, the former CIO of Boston Medical Center and now a principal at Aranow Consulting recently assembled several of the IT leaders in Boston to discuss opportunities for reducing costs and enhancing infrastructure by pooling our collective resources.   Here's her guest post describing the exploration:

"I recently met with IT leadership from Partners Healthcare, Childrens Hospital Boston and Beth Israel Deaconess, all teaching affiliates of Harvard.  The topic around which we convened was to discuss the idea of a collaborative datacenter.

With the potential upside of staffing and procurement efficiencies stipulated as a launching point for the discussion the conversation turned to what it would take to make it happen.

There were issues of (very) long term lease obligations, the cost of re-routing communication lines and the daunting spectra of demanding SLAs.

Clearly all of these challenges could be met by the combined IT talent…given a solid business case, time and resources.  But it was also clear that given all of the demands IT departments are already facing  – several of which are federally sponsored - this particular business case would have a hard time swimming to the surface.

Although I had been ready to engage in a vibrant discussion about competing business priorities, there was a vibe that nothing short of either fortuitous opportunity (i.e. the coincidental conclusion of independently negotiated leases) or a mandate would get enough attention to even be debated.  The business case we built would have needed to be great, not just good or promising.

I am not sure if a collaborative datacenter is a good, never mind the best, idea.  But the more general observation is that the current climate makes it difficult to devote resources to the exploration of new ideas.  Most of hospital IT is consumed with 1) the day-to-day support and tweaking of what already exists and 2) projects in support of the legally mandated future initiatives.

We concluded the meeting thinking it might be an interesting idea to some day explore if there were time.  But not now. "

Thanks for doing this Meg.  In a world of infinite demand and limited IT supply, all CIOs feel "time bankrupt".   The alignment of opportunity, regulatory mandate, cost pressures,  politics, and prioritization is definitely a perfect storm that occurs only rarely.

An Expert's Guide to Moving

Kathy and I move from our current house to our farm on April 27, so we have just one weekend of packing to go.    Nancy P from Dallas posted a spectacular comment that is so accurate and timely I had to share it broadly:

"K. and J. - You may enjoy my 30 day packing calendar, written from my experience.

DAYS 1-5: We are lovingly admiring and discussing each of our material possessions while discarding what we no longer use. We’ll have a garage sale and make trips to Goodwill to donate unused items. I’ll wash, dry and organize objects to be sold or donated. We have plenty of boxes, bubble wrap, Sharpie pens and packing tape. Boxes are organized in categories based on their contents. We write a detailed list of the items in the right-hand corner of the top of the box and carefully seal it with packing tape.

DAYS 6-10: It is not realistic to cull through all of our belongings in 30 days. We’ll cull and reflect when we unpack. We’ll also have a lot more time when we unpack to plan a garage sale or make trips to Goodwill. A detailed list of contents of each box is not needed, so all boxes are now labeled only with a general category in the upper right hand corner. I’m segregating my son’s possessions so he can go through them himself. Things are starting to look a little messy around here. I need a GPS to locate that cup of tea I keep misplacing!

DAYS 11-15: It is increasingly unproductive to sort and categorize items before boxing them. So with the miracle of bubble wrap, we’ve taken a new approach: We can simply dump the contents of an entire drawer in bubble wrap, stuff the bubble wrap in a box, and label the box with the location of the drawer, like 'Master Bathroom: far left cabinet, third drawer down.' We’re able to safely pack in bubble wrap the entire contents of drawers and closets in no time at all. We’ll just sort and categorize the contents of these boxes when we unpack.

DAYS 16-20: Bubble wrap is overrated. You can only fit about ½ as much stuff in a box when you use it. And it takes forever to cut the size you need. Plus - you pack items between the bubble wrap layers, and many of these things will fall out from the layers and break as you unpack, so what’s the point? I’m trying to be more pragmatic. After all, these are only material possessions. As Bertrand Russell so eloquently stated 'It is preoccupation with possessions, more than anything else, that prevents men from living freely and nobly.' And as I so freely and nobly state 'Do we really need two full sets of martini glasses, anyway?'

DAYS 21-25: Rather than box up and move things of value that we don’t want, we will simply leave them behind for the new proprietors. I doubt the new owners will mind that we leave them items with inherent use and value - like that 30 pound Folgers coffee tin full of nuts and bolts in the garage. The value of the nuts and bolts aside, the tin itself is an antique. And we haven’t even opened those tubs of frozen yogurt in the freezer, which would make a thoughtful housewarming surprise. We’ve also learned that we don’t need to tape every box, because they are just being stacked on top of each other, so we only need to tape the top one.

DAYS 26-30: The realtor stopped by and declared that we can’t leave anything behind for the new owners. 'It all has to go,' she said with that little smug look that I have grown to dislike. So all the rest of this stuff is going out on the curb, and whoever wants to pick it up can have it. And if my kid wants his things…well…he’ll just have to come get them, or they will also be out there with the rest of our clutter. How did we accumulate all of this worthless stuff? What could we possibly have wanted with 73 packets of soy sauce? The realtor also found my misplaced cup of tea somewhere in the front hall. I did not appreciate the face she made; very unprofessional, if you ask me. And by the way, you do need to tape up each and every box –but I’ll spare you the details - and before I tape up my next box, I’m just throwing the Sharpies in there with them. Because at this point what am I going to write in corner of the box, 'Lots of other crap'? I’m overwhelmed…I really need to take a break…Damn it, I packed the martini glasses!"

Although I've never owned a martini glass, we'll be in Days 26-30 next weekend and I suspect I'll need one!

Cool Technology of the Week

I've written several posts about BIDMC's use of "private cloud" approaches to host electronic records and gather community-wide quality data.   Healthcare organizations have avoided the use of "public cloud"  because of HIPAA/HITECH privacy concerns, lack of breach indemnification/data integrity guarantees, and the unwillingness of many cloud providers to sign business associate agreements.

Although it has not been widely discussed in the industry, the Centers for Disease Control and Prevention's (CDC) Biosense 2.0 initiative has done ground breaking work to solve these issues, using Amazon's AWS GovCloud to create a national repository of syndromic surveillance data that includes all the protections needed to protect privacy including independent security testing at the FISMA-Moderate Level.

CDC is the first government agency to complete all the rigorous certification needed to host sensitive data in the public cloud.

CDC has also built gateways that make it easy for public health departments to submit data to the cloud - a Direct Project adapter, an NwHIN Exchange adapter, and others.    Meaningful Use Stage 1 requires the testing of health information exchange with public health and Beth Israel Deaconess did its transactions with the Boston Public Health Commission (BPHC), which stored them in CDC's public cloud.  BPHC was the first public health department in the nation to provide data feeds to the Amazon infrastructure.

Finally, CDC has enabled queries of the cloud data using multiple platforms including open source analytical tools such as R.

A secure, HIPAA-compliant public cloud that includes healthcare information exchange gateways and analytical tools.   That's cool!

Our Cancer Journey Week 17

Although Kathy's body is sore and her hands/feet are numb, her mood is good as we finalize our house sale, pick out the chickens we'll raise on the new farm, and prepare for the life ahead instead of looking back on our old life and the events of the past 5 months.

She lost her last eyebrow hairs this week and the toenails on her big toes will likely fall off soon.   She cannot open jars or water bottles because of diminished grip strength and today she visits the orthopedist for followup of her probable right knee medial collateral ligament tear.  But she's happy.

The chickens we've decided to raise are Buff Orpingtons, Jersey Giants, and Brahmas  - all docile large breeds.    We'll likely raise a small number to start with, ensuring we learn chicken care incrementally.   We have local farms and grain mills as well as web-based chicken farming resources to help us.   This Summer, we'll build a portable chicken tractor, then design a permanent coop for Winter.

Just 4 more treatments of Taxol and then hopefully Kathy's weakness/numbness will resolve as we move onto surgery and radiation.

Milestones ahead - films/orthopedic examination today, MRI of the breast on April 25 to determine if any detectable tumor remains, then a breast surgeon appointment on May 31.   Although lumpectomy is a long shot and mastectomy is likely, Kathy's response to chemotherapy has been so good, that there's a possibility for minor rather than major surgery.   We'll know by June, just about the time our chickens will be old enough to enjoy the long Summer days outside in our meadow.

Clinical Query, I2B2, and QueryHealth

Today I'm presenting an overview of our new clinical trials/clinical research business intelligence system, called Clinical Query to the BIDMC Chiefs and Vice Presidents.

Here are the slides I'll use.

The principle behind Clinical Query is that investigators will want to ask questions, preliminary to research, that will help them understand the potential statistical power of a clinical trial or the availability of data for clinical research.

What did we do?

We loaded 2.2 million patients (1997 to the present) and 200 million data elements into a repository,  ensuring that every data element was mapped to a controlled vocabulary.  When then built a web-based query tool capable of navigating 20,000 medical concepts via boolean (AND/OR) expressions of arbitrary complexity.

Labs were mapped to LOINC codes.

Problems/Encounter Diagnoses were mapped to SNOMED-CT codes.

Medications and Allergies were mapped to RxNorm codes

Demographics were mapped to the same code sets required for Meaningful Use.

The result is that any authorized user, who has completed our institutional HIPAA training, can run real time population queries.

For example, since my wife has Breast Cancer and has taken Ace Inhibitors, maybe I want to study the association of the two and I need a cohort of potential subjects.    The query from start to finish took 3 seconds and yielded 2421 +/- 3 patients.

Why +/- 3?

We never report the exact number to ensure that the privacy of individual patients is protected since I could create a query so arcane that it identifies a single individual.   The fictional example I've used in lectures is: "my neighbor has one blue and one green eye.   Show me the count of all blue-eyed, green-eyed people taking mental health medications."  A count of 1 could be disclosing.    By adding arbitrary numbers to every result we ensure that population queries remain ambiguous.

The BIDMC and Harvard-wide Institutional Review Boards (IRB) decided that aggregate de-identified queries, preliminary to research, may be done by authorized, trained users without requiring IRB approval.

Additional data extraction that would be used as part of offering a clinical trial or clinical research opportunity to a patient does require IRB approval.

Many novel explorations are possible such as the fact that 80,000 patients had ischemic heart disease and no history of Vioxx use, while 800 patients had ischemic heart disease and took Vioxx, which was withdrawn from the market in 2004 because of concerns about increased risk of heart attack and stroke with long-term, high-dosage use.   Clinical Query can help investigators explore the temporal relationship between the introduction of Vioxx and the frequency of ischemic heart disease.

Clinical Query is based on the I2B2 Standards for aggregate query/response of clinical data bases.   Over 60 hospitals have implemented I2B2 applications, often in support of the Clinical and Translational Science Awards (CTSA).

I've written about the QueryHealth initiative which is using HL7 Health Quality Measures Format (HQMF) to query heterogeneous data sources.

What if the QueryHealth initiative could access I2B2 connected data sources, such as enabling pharmaco-vigilance queries from the FDA to be broadcast across the country?

We can best protect privacy by keeping all our patient identified data inside our data center and responding to external queries from payers, government agencies, and public health with aggregate numbers.   Reporting on the number of patients taking Vioxx and the number of patients presenting with chest pain without submitting patient identified data to external registries minimizes risk.

We'll explore the intersection of QueryHealth and I2B2 at BIDMC in the upcoming months and I'll write about that, just as I wrote about our PopHealth lessons learned.

I've written about our efforts to Free the Data and create a learning healthcare system.    Today marks a milestone for enabling our data to be explored with Clinical Query while protecting the security and integrity of our enterprise registries and repositories.