Proposal: Create a Comprehensive Treatment Review Program

Marco

Grrrrrrr!
Messages
2,386
Likes
3,218
Location
Near Cognac, France
Another method to consider for the analysis stage is to develop a 'rich picture'. As you probably all know, this is to consider the wider technical, political, medical etc environment in which the system will exist. E.g. defining the various client groups - PWCs, advocacy groups, researchers, the wider medical community, government agencies, regulatory bodies etc - and how these might impact on the specification and feasibility of the project.

Its here that the issues raised by Julie might become apparent.

While I appreciate the concerns Julie raises, and in an ideal world qualified researchers should have already done this, I have a different perspective.

I strongly feel that the ME/CFS field has been continually hampered by research being taken out of the hands of and divorced from the real experience of PWCs. Hence the numerous studies and definitions that accentuate 'fatigue' while ignoring the myriad other and in fact cardinal symptoms. Sometimes this is deliberate and sometimes a pragmatic decision to be able to clear some trees to see the wood.

The end result however is that few descriptions used by the medical profession fully capture the illness. Procedures, practices, ethical/legal protocols etc have only served to dilute the wider understanding of the illness. We may not fully understand the biological processes at work, but in ME/CFS, neither do the medical professionals. This doesn't however prevent us from describing our symptoms as we experience them and describing the effects experienced by various treatments.

I can't see how a patient led project can violate legal/ethical rules but we also need to ensure that its taken seriously. Obviously the project will gain more traction if, for example, measures used are in common usage in the research community.

Perhaps once we have a firm spec it can be distributed more widely for discussion with interested parties.
 

Cort

Phoenix Rising Founder
Messages
7,371
Likes
2,122
Location
Arizona in winter & W. North America otherwise
a
I think this is a noble, understandable and note worthy approach and I commend your idea. However, I feel restrictions by the AMA, will prevent progress with such a project unless it is done in a clinical setting. There is potential for lawsuits to hold this project up, due to various licenses needed to pursue such a project; if not done within legal parameters. I believe (my opinion only) that Licensed Physicians, Scientists and Researchers need to be implementing these future systems you mention; and I believe these will definitely be instituted through medical and political reforis im in the near future. For now, I believe our time, energy and donations should go towards advocacy, research and outreach programs to help those who are actively coping with symptoms. As far as the program you mention/outline, there are patient privacy rights to be considered plus a greater understanding of biological and medical training needs to be understood that can only be obtained through intensive education and practice which is essential to gain perspective on this and all diseases. Becoming a board certified physician and specialist takes every ounce and energy and time of a 10+ year process, if not a lifetime of understanding. To skip this educational process in order to set up a medical research project, the understandings and needs of the biological processes at hand needed for such a project involving patient procedures would lack imperative substance. I feel Pheonix Rising has created an incredible network for disseminating information, for sharing opinions and viewpoints and for getting information circulated about Fibro/ME/CFS/CFIDS. THis accomplishment alone is an incredible gift and has furthered advocacy for our disease. I believe that the more we unite as a group through our available web site forums, the more shifts and progress that will be made towards progress for our disease. Cort, you have made an invaluable contribution through this site and I am very grateful for your work, this site and the information provided. Getting back to your ideas....It may be that a committee will be formed at some point through one of the newly formed institutes and that your ideas and plans will be put into place by physicians, researchers and scientists. I think it is possible that you will be a part of one of these teams which will put into place new systems, etc.....
I understand your concerns Julie but a similar system has been functioning at PatientsLikeMe for several years now and its proved very successful at illuminating successful (and not successful) treatment options for different diseases. A system like this, of course, will never be as rigorous as a scientific study but it has the potential to provide more information much more quickly to patients. Even in well researched diseases treatment trials often consist of limited numbers of patients that are hardly representative of the entire patient community. Of course in a disease like ME/CFS where treatment trials are rare and patients are using an enormous number of different treatments getting a handle on treatment efficacy is critical. PatientsLikeMe was basically born, so far as I can tell, out of frustration at a slow-moving medical that proved unable to provide timely and nuanced information on treatment options.

It is a large task but so long as we consider it carefully, get input from qualified people on the technical and health industry end, I think its doable and really needed and we're going through the process of determining what is feasible and what is not. Thanks
 

JT1024

Senior Member
Messages
582
Likes
414
Location
Massachusetts
It appears PLM is willing to collaborate in some cases. Information below is from their website:

Q: I am a clinician / researcher and would like to collaborate with you on a new research project. Who should I contact?

A: We are proud to collaborate with some of the leading research institutions in the world on useful and interesting academic research. Please write to the research team with your initial
research proposal. If we think a research project has the potential to benefit our users we would be happy to assist you in writing a grant proposal and helping to describe what we do for
your local Internal Review Board (IRB). The proportion of funding we would receive depends on a number of factors including the contribution of our staff to the design, the difficulty of
accessing the specific population of interest, and the source of funding.
 

JT1024

Senior Member
Messages
582
Likes
414
Location
Massachusetts
Here is an article on analytical processing that may be useful to some. The healthcare IT company I used to work for used a relational database (OLTP) for most data transactions but also used OLAP for fast reporting capabilities. Appears there is a new option.

While this is obviously not an option for Phoenix Rising at this point due to cost, it is an option for other companies (PLM) and healthcare organizations that may help our cause at some point. Thought I would share...

Goodbye Data Warehouse and Cubes, Hello AQL
By Mark Moffitt


For the last two years, I have been researching systems to replace the data warehouse used for report-writing in our organization. This effort has been driven by the desire to provide better service to other departments that rely heavily on data reporting for day-to-day operations.

The idea is to push data to users so they can perform in-memory analysis and display of large amounts of data, a system that would replace the current process of requesting custom reports and spreadsheets from the information services (IS) department. The current process requires considerable resources in the IS department and requests can take several days if the number of requests for reports in the queue becomes large.

The requirements for a new system are straightforward, but somewhat daunting:

1. Put data into users hands so they can perform business intelligence.

2. The cost of the system, including license, hardware, and consulting, must be offset by the direct costs of shutting down existing systems.

At GSMC we operate Meditech Magic and use a data warehouse for analytics and business intelligence. The data warehouse stores about nine years of financial data in about 650 GB. The data in the warehouse is updated nightly. SQL reports have been developed to provide reporting across the organization.

IS at GSMC is bombarded with requests for new reports. These requests come in the form of specialized requests for data that often require modifying an existing SQL query or writing a new query. The process is iterative that starts with gathering requirements for a report, modifying or writing new SQL queries, generating a report and sending it to the customer.

Typical turnaround times are variable and are highly dependent on the number of reports in the queue to be developed. Best case scenario is four hours, typical is two to four days. Often the customer will, upon review of the report, ask to include or exclude specific data. This back-and-forth typically occurs several times until the report meets the customers needs.

The IS department at GSMC has several analysts who spend a good part of their time responding to requests for data. It is a never-ending demand.

We researched the use of OLAP (online analytical processing) cubes to provide data to users. The advantages of cubes is well documented and includes the ability to drill down to details and analyze data in ways simply not possible with reports or spreadsheets. The disadvantage to cubes is that data must first be aggregated. If a user needs data not included in the cube, then the cube must be rebuilt. Also, a data warehouse is required. Finally, building and maintaining cubes require personnel with specialized skills.

About seven months ago, I read on HIStalk about a new company named QlikView. I researched the software and it sounded too good to be true. However, I was intrigued that QlikView doubled revenues in 2008, not an especially good year for selling enterprise software as the national economy was in a major recession.

On the surface, QlikView is a business intelligence solution that consists of a data source integration module, analytics engine, and user interface. QlikView is based on AQL and is completely different from other OLAP tools.

Through AQL, QlikView eliminates the need for OLAP cubes and a data warehouse, replacing the cube structure with a Data Cloud. A Data Cloud does not contain any pre-aggregated data but instead builds non-redundant tables and keeps them in memory at all times. Queries are then created on the fly and are run against the Data Clouds in-memory data store.

Under AQL, all data is stored only once, and all data associations are stored as pointers, so a Data Cloud database becomes more efficient at retrieving records than do OLAP databases. A Data Cloud database is also much smaller since records are not repeated through aggregation and its structure never has to change. The architecture allows for a flexible end-user experience because it doesnt require aggregation or pre-canned queries that try to cover every possible analytical scenario a user can create, unlike data cubes that require both. (1)

Data Clouds run in memory and AQL reduces in-memory storage requirements by about 75% as compared to source data. In-memory Data Clouds can be stored as AQL files for archiving. AQL disk files are 90% smaller than source data. Think of an AQL file like an Excel file where data can be added and deleted and the file saved with different names for archiving purposes.

The price point for the software is about $150,000 (one-time fee) for our health system. Hardware costs are about $15,000 for a server with 98 GB of memory. We expect consulting fees to total $150,000 for a SME in hospital financial data with QlikView experience. We worked with RSM McGladrey on a consulting proposal as they have well-qualified personnel in this space.

If you know much about the BI/Analytics space, you may question the low cost of the software and consulting services. This has everything to do with the AQL model. RSM McGladrey quoted a revenue cycle effort at eight weeks and includes:

Transfer data from existing systems to QlikView
Data validation
Census analysis
AR analysis
Insurance contract analysis
Hindsight analysis
Train IS staff on data extraction
The revenue cycle statement of work is only one component of the $150,000 quote for consulting services from RSM McGladrey for implementing QlikView at our organization.

The total cost for QlikView at GSMC is $315,000. That will be directly offset by shutting down a data warehouse, savings from using QlikView for analytics versus another system where the cost of consulting services had already been quoted and budgeted, and other savings. We expect additional direct benefits from having deep analytic capabilities with our revenue cycle data.

QlikView has a number or healthcare customers. I believe you will be hearing more about the company in healthcare in the years ahead as they achieve market awareness of QlikView softwares capabilities and price point.

We have not yet purchased the package. If we do, Ill write a follow-up article on our experience.

1 Qliktech, IBM Provide New View Of OLAP, Mario Morejon, Technical writer for ChannelWeb, July 18, 2003, http://www.crn.com/software/18839582

Mark Moffitt is CIO at Good Shepherd Medical Center in Longview, TX.
 

Andrew

Senior Member
Messages
2,388
Likes
3,281
Location
Los Angeles, USA
My general point is simply: Personally, I am with Cort in thinking that the PR-forums could produce very interesting data about a large group of patients with ME/CFS and it's probably very worthwile to analyze it ourselves, if we can. And I think we can in principle, and certainly to some extent if only in good spreadsheets
Yes, that was my point. I also included an example of this.

As to: "As long as our data is available in a tabular or separated format": It actually doesn't matter as long as datablocks are somehow reliably separated and in ASCII text-format. If they are reliably separated - by beginning and endmarkers - and in txt it is easy to recook them to any standard a statistical package accepts, which generally is of the form tab-, comma-, or line-separated between blocks. (So actually is easier than to understand my written explanation, and spreadsheets do these things also for one ;).
I fail to see the disagreement with what I said. You just described separated format.

And only later commit ourselves to anything or any software or spend money on software before we have tolerably clear ideas about the possibilities, of which there are many.
Makes sense.
 
Messages
877
Likes
85
I would like to see a "what worked for me" forum topic where patients that have gone into remission could share experieces for others to benefit from. Then patients could find their own role model, or guinney pig to emulate.

I think a few of those success stories are going on here, but those stories are hard to find without a specific forum location....
 

Advocate

Senior Member
Messages
529
Likes
91
Location
U.S.A.
Thanks JT - good idea of on the SF-36; from my knowledge that is the most commonly used test in the research field.
The American Journal of Medicine
Volume 101, Issue 4, Pages 364-370 (October 1996)

Functional status in patients with chronic fatigue syndrome, other fatiguing illnesses, and healthy individuals

MD Dedra Buchwalda, BA Tsilke Pearlmana, BA Jovine Umalia, PhD Karen Schmalingb, MD Wayne Katonb


...The SF-36 is useful in assessing functional status in patients with fatiguing illnesses. Patients with CFS and CF have marked impairment of their functional status. The severity and pattern of impairment as documented by the SF-36 distinguishes patients with CFS and CF from those with MD and AIM, and from HC, but does not discriminate between CF and CFS.


http://www.amjmed.com/article/S0002-9343(96)00234-3/abstract
 

ukme

Senior Member
Messages
169
Likes
8
I would like to see a "what worked for me" forum topic where patients that have gone into remission could share experieces for others to benefit from. Then patients could find their own role model, or guinney pig to emulate.

I think a few of those success stories are going on here, but those stories are hard to find without a specific forum location....
I would agree with this
 

Advocate

Senior Member
Messages
529
Likes
91
Location
U.S.A.
There is an article related to this discussion in today's New York Times: When Patients Meet Online, Are There Side Effects?

The article raises important questions about the trade-off between the benefits of information sharing and the risk of patient exploitation by corporations who buy the information for marketing purposes. It's tricky.

After the XMRV study was published in Science, someone on this forum begged the pharmaceutical industry, "Exploit me!" I understand the feeling.

Advocate
 

Mark

Senior Member
Messages
5,238
Likes
6,200
Location
Sofa, UK
I would like to see a "what worked for me" forum topic where patients that have gone into remission could share experieces for others to benefit from. Then patients could find their own role model, or guinney pig to emulate.

I think a few of those success stories are going on here, but those stories are hard to find without a specific forum location....
This sounds like a great idea, worth starting a thread for this...

ETA: we could make it sticky / move it later. And any other ideas about how to index information and/or make things like this easier to find, would be welcome...
 
Messages
23
Likes
1
Location
D/FW TX
This will initially sound crazy, but I highly recommend that you check out the www.ravelry.com site.
It is a crafting site for those who knit and crochet, which initially seems totally unrelated to anything you're talking about here. :)

However.

The site design and functionality is AMAZING.
It is, at heart, an incredibly complex and interactive user-friendly database.
It allows users to input a staggering assortment of data-types, including, text, images, links, etc, and then to tag, sort, filter, and FIND that data in a variety of very flexible ways.

I think Casey, the developer, has probably figured out how to do a lot of what you're hoping to do with your data - ie, store it so that it can be cross-referenced and recalled in useful ways.
 

energyoverload

Senior Member
Messages
171
Likes
167
Location
London
Hi Cort,

I think your ideas for this website are fantastic. This would create such a vitally useful resource for both patients, physicians and possibly even researchers alike. The patientslikeme model seems to be very solid.

Do you think it would be worth setting up a specific paypal account for this project so that people will realize their contributions will specifically enable PR to do big new things - i.e. create this new site.

Also this is obviously further down the line, but what do you think about getting Pharmaceutical sponsorship for the sites or just putting their ads for specific antiretrovirals, ampligen etc. on the site. This would generate some revenue to pay off the production and maintainance costs.?

Have you taken a look at the aidsmeds.com site? I think that is also a useful resource & in a useable format, but it does not incorporate such advanced features as the patientslikeme site.

I have just registered the domains: HGRADMEDS.com and HGRVMEDS.com

Be good to hear your thoughts!

Jake
 

Enid

Senior Member
Messages
3,309
Likes
868
Location
UK
Late in the day- sounds a great idea Cort. I thnk "patients like me" will be reflecting differing stages of the disease and to bring together eg Dr Myhill et al protocols for bowel, energy, cognitive, muscle, heart, pain problems etc would be a great help - sort of what is best/advised.
 

moblet

Unknown Quantity
Messages
354
Likes
599
Location
Somewhere in Australia
I realise this concept is on the backburner, but just wanted to make some observations:
1. PLM is a for-profit operation that makes its money by selling the contents of its database to interested parties, mostly drug companies and researchers. It's not going to be in their interests to help someone else develop a competing database, the contents of which are given away for free in the interests of the greater good, as this undermines their business model.
2. If this database were to also become a for-profit exercise, its design would/should then be influenced by what paying customers want. That might simplify design, but may not serve the greater good, as we can't assume that the set of entities willing and able to pay for the data exactly matches the set of entities motivated in the greater good. It also has the potential to skew both design and population towards treatments that can be patented (e.g. drugs) and away from those that can't (e.g. most physical therapies and basic supplements). This certainly appears to be case in PLM, although I'm not in the US and I'm aware that in that country drugs are proferred as the solution to absolutely everything.
3. #2 also applies to accepting sponsorship from any entity with a vested interest in how conditions are treated. Even if it sponsorship doesn't influence the database, it's not a good look. To be trusted it must be seen to be independent.
4. In PLM, when indicating why one has ceased a particular treatment, "I got better and no longer needed it" is not an option. In other words, it's taken for granted that not a single one of any patient's conditions will ever be cured! Interesting assumption, and hopefully not related to #2.
 

Andrew

Senior Member
Messages
2,388
Likes
3,281
Location
Los Angeles, USA
Here's an idea for a smaller project, or even the beginnings of a small part of the larger project.

First, look at this page: http://www.lassesen.com/cfids/protocols.htm

This is an attempt to quantify the success of a given protocol based on patient reports. I don't know if I ever mentioned this before.

Here is what I just posted to the Experimental Group. It could happen here or there or both places.

I propose that some of us attempt the same type of project based on the book Reviving the Broken Marionette: Treatments for CFS/ME and Fibromyalgia.

If someone can give me the spreadsheet and explain input, I'll try to do this myself. It could take a long time at my current health level, but I think I might be able to pick out the top 10 protocols and enter them. Or maybe I can work in partnership with the person who knows about the spreadsheet. That might be better. Or whatever you suggest. I can only concentrate in short bursts, but I did just spend many months skimming and highlighting the book. So, in theory, I should have it somewhat narrowed down. And my basic idea is we would list only those protocols that have a study with a minimum number of participants.
Thoughts?