When developing and presenting guidelines (and evaluating and interpreting guidelines) considerations include:
1) the methodology for how content is determined, including
a) evidence for representing facts or approximations of effects of actions
b) value judgments
c) recommendations (derived from interpretation of a and b)
2) the content itself (What is the best factual representation of the evidence? Of the value judgments? What are the recommendations being made?)
3) the presentation (format, phrasing) of the content
One can claim using EBM or using a specific approach to EBM for one of these components, and imply that it is used for all components. This blurring of specification of what is meant when EBM is used or when GRADE is used confuses the dialog and can lead to cross-talk when "opposite sides" are arguing using different concepts and not paying attention to what each is saying.
It is possible to present a guideline using the GRADE framework (spelling out selective interpretation of evidence, value judgments and recommendations) and express it with attention to clearly explaining all the factors to support a desired presentation. That is not the same thing as a multi-perspective consideration of all the evidence and value judgments and representation of the widest collection of views and values when producing recommendations.
When this occurs "opposite sides" can argue about which evidence is more valid, which ways of interpreting the evidence are more valid, which values are more representative of the population at large, which "conflicts of interest" are conflicts to protect against and which ones are considered nonconflicting and part of the "expertise" being applied (anyone involved in guideline development has some interest, so there can be a difference of opinion in which interests are conflicts).
One could look at the different Lyme disease guidelines and find examples for all of these concepts that are "in opposition". Figuring out how to handle this instead of getting caught in a debate of which one is EBM, or EBM vs. mislabeled EBM, or choice of EBM methods, may be the best way forward for framing this.
Brian S. Alper, MD, MSPH, FAAFP
Founder of DynaMed
Vice President of EBM Research and Development, Quality & Standards
dynamed.ebscohost.com
-----Original Message-----
From: Evidence based health (EBH) [mailto:[log in to unmask]] On Behalf Of Djulbegovic, Benjamin
Sent: Sunday, August 03, 2014 8:28 AM
To: [log in to unmask]
Subject: Re: New Standard of Care Guidelines for Treating Lyme and Other Tick-borne Illnesses
I think what is fascinating here is that scores between competing groups/views are being settled over the choice of EBM methods...what are "right"/"best" EBM methods?
The latest Lyme guidelines purportedly rely on GRADE and Cochrane Collaboration methods. I think this example heralds a new era in EBM: the need for more specificity in EBM methods ( as clearly not all guidelines/ research methods are created equal)...
Ben
Ps I have not checked if the latest Lyme guidelines appropriately used GRADE methodology ( hopefully someone will do it), but I can see that people will increasingly require the assessment of the quality of guidelines using instruments such as AGREE II as Douglas already suggested....
Sent from my iPad
( please excuse typos & brevity)
> On Aug 2, 2014, at 9:44 PM, "healingjia Price" <[log in to unmask]> wrote:
>
> The patient groups were alerting us to the discrepancies in Lyme
> disease recommendations long before the paper which is quite detailed
> and it isn't so clean in recruiting for psychiatric drug research
> either and this is in USA
> https://medium.com/matter/did-big-pharma-test-your-meds-on-homeless-pe
> ople-a6d8d3fc7dfe
>
> I wonder where the balance is in moving forward in research ethically while standing up for the vulnerable and how to pick these battles.
>
> Best
> Amy
>
>
> Amy Price
> Empower 2 Go
> Building Brain Potential
> Http://empower2go.org
> Sent from my iPad
>
>> On 2 Aug 2014, at 01:19 pm, "Juan Gérvas" <[log in to unmask]> wrote:
>>
>> -excellent paper, Ben
>> -i know more about psychiatric problems
>> http://onlinelibrary.wiley.com/doi/10.1111/jep.12016/abstract;jsessio
>> nid=C42625918F6541C06ED58354F924C720.f03t04?deniedAccessCustomisedMes
>> sage=&userIsAuthenticated=false -in any case, the Infectious Diseases
>> Society of America (IDSA) is usually very close to pharmaceutical
>> industries, as demonstrated at the beginning of the year with the
>> "Tamiflu-Relenza" saga -un saludo -juan gérvas
>>
>> 2014-08-01 21:21 GMT+02:00, Djulbegovic, Benjamin <[log in to unmask]>:
>>> This definitively deserves a debate: in May of 2008, the Attorney
>>> General of Connecticut conducted antitrust investigation into the
>>> development of Lyme disease treatment guidelines by the Infectious
>>> Diseases Society of America (IDSA). The thrust of his argument is
>>> that the IDSA developed guidelines based on flawed methodology that
>>> in turn forced false standard of care, which cannot benefit the
>>> patients ( see http://www.peh-med.com/content/5/1/9).
>>> Lyme disease is one of those diseases that has been politicized
>>> leading to a number of conspiracy theories accusing the (US)
>>> government of suppression of evidence , all kinds of conflict of
>>> interests, etc, etc. The battle is now taken to the EBM: which
>>> methods are right ones and which guidelines are trustworthy? This
>>> is a paradigmitic example where science intersects with politics, ethics and public health policy.
>>> I look forward to some interesting and stimulating insights.
>>> thanks
>>> ben d
>>>
>>>
>>>
>>>
>>> From: Evidence based health (EBH)
>>> [mailto:[log in to unmask]] On Behalf Of Kate
>>> Bloor
>>> Sent: Thursday, July 31, 2014 11:05 AM
>>> To: [log in to unmask]
>>> Subject: Fw: New Standard of Care Guidelines for Treating Lyme and
>>> Other Tick-borne Illnesses
>>>
>>>
>>>
>>> I've not seen any discussion on the list on the IDSA/ ILADS divide
>>> related to testing, diagnosis and treatment for lyme disease and other TBI's.
>>>
>>> One have claimed jurisdiction over the other - on grounds of the
>>> evidence base, and professional legitimacy. However some claim that
>>> key european research related to european tests, diagnosis and lyme
>>> disease clinical presentations, has not often been included, and
>>> that this control of the diagnostic agenda is no more than 'traditional authority'.
>>>
>>> Given that lyme infection, is the fastest growing vector borne
>>> disease in the Northern Hemisphere, it is perhaps one the most major
>>> public health threats of its kind in europe and beyond, this is a
>>> worthy debate. Also given its contraversial nature, and the general
>>> climate of tensions between doctors, patients, and health services,
>>> it deserves a wider debate amongst a broader range of academic and
>>> professional groups, and patients advocacy groups.
>>>
>>> I bring this to your attention. See new guidelines from ILADS below.
>>>
>>> Kate Bloor
>>>
>>>
>>>
>>>
>>> New Standard of Care Guidelines for Treating Lyme and Other
>>> Tick-borne Illnesses Released by International Lyme and Associated
>>> Diseases Society
>>> (ILADS)
>>> Bethesda, Maryland, July 31, 2014
>>> How doctors treat patients with suspected Lyme infections needs to
>>> change so as to avoid potential long term illness and suffering. To
>>> that end, the International Lyme and Associated Diseases
>>> Society<http://ilads.us8.list-manage1.com/track/click?u=618a4780f786
>>> 30b439260ac0a&id=851d1c7c84&e=bd3361534c>
>>> (ILADS) today released updated guidelines for the treatment of Lyme
>>> and other tick borne infections which call on physicians to provide
>>> evidence-based, patient-centered care for those with Lyme disease.
>>>
>>> Published in the August 2014 edition of the journal Expert Review of
>>> Anti-infective
>>> Therapy<http://ilads.us8.list-manage1.com/track/click?u=618a4780f786
>>> 30b439260ac0a&id=7437aebf44&e=bd3361534c>,
>>> the new guidelines, titled: Evidence Assessments and Guideline
>>> Recommendations in Lyme disease: The Clinical Management of Known
>>> Tick Bites, Erythema Migrans Rashes and Persistent Disease, say
>>> current antibiotic protocols used by many physicians to prevent or
>>> treat Lyme disease are inadequate, leading to an increased risk of
>>> Lyme disease developing into a chronic illness.
>>>
>>> "Chronic manifestations of Lyme disease can continue long after
>>> other markers of the disease, such as the erythema migrans rash, have resolved,"
>>> said Daniel Cameron, M.D., M.P.H., and lead author. "Understanding
>>> this reality underlies the recommendation for careful follow-up to
>>> determine which individuals with Lyme disease could benefit from
>>> additional antibiotic therapy."
>>>
>>> ILADS is the first organization to issue guidelines on Lyme disease
>>> which comply with the standards set by the Institute of
>>> Medicine<http://ilads.us8.list-manage.com/track/click?u=618a4780f786
>>> 30b439260ac0a&id=eda720d448&e=bd3361534c>
>>> for developing trustworthy protocols. The document provides a
>>> rigorous review of the pertinent medical literature and contains
>>> recommendations for Lyme disease treatment based on the Grading of
>>> Recommendations Assessment, Development, and Evaluation
>>> (GRADE<http://ilads.us8.list-manage1.com/track/click?u=618a4780f7863
>>> 0b439260ac0a&id=02e3f60668&e=bd3361534c>)
>>> process. This review format is used by other well-respected medical
>>> organizations<http://ilads.us8.list-manage1.com/track/click?u=618a47
>>> 80f78630b439260ac0a&id=c4e0518851&e=bd3361534c>
>>> including the Cochrane
>>> Collaboration<http://ilads.us8.list-manage.com/track/click?u=618a478
>>> 0f78630b439260ac0a&id=1b574891f5&e=bd3361534c>
>>> and the World Health
>>> Organization<http://ilads.us8.list-manage1.com/track/click?u=618a4780f78630b439260ac0a&id=1fbf9a278f&e=bd3361534c>.
>>>
>>> ILADS' GRADE-based analyses discovered research studies guiding
>>> current treatment protocols were of very low quality; and, the
>>> regimens based on these randomized controlled trials often failed.
>>> "For this reason, we moved away from designating a fixed duration
>>> for antibiotic therapy for tick borne illnesses and instead
>>> encourage clinicians to tailor therapy based on the patient's response to treatment," noted Dr. Cameron.
>>>
>>> "We not only recommend clinicians perform a deliberate and
>>> individualized assessment of the potential risks and benefits of
>>> various treatment options before making their initial selection,"
>>> said guidelines coauthor Elizabeth Maloney, M.D., "we also recommend
>>> careful follow-up. Monitoring a patient allows clinicians to adjust
>>> therapy as circumstances evolve. This more selective approach should
>>> reduce the risk of inadequate treatment giving rise to a chronic illness," added Dr. Maloney.
>>>
>>> The guidelines encourage shared medical decision making and taking
>>> patient values into consideration. Lorraine Johnson, J.D., MBA, a
>>> coauthor and Executive Director of
>>> LymeDisease.org<http://ilads.us8.list-manage.com/track/click?u=618a4
>>> 780f78630b439260ac0a&id=e4e94524b4&e=bd3361534c>,
>>> noted, "A lot of the treatment decisions in Lyme disease depend on
>>> trade-offs. How sick is the patient? How invasive is the treatment?
>>> What is valued by the patient? Patients need to understand the risks
>>> and benefits of treatment options to make informed medical choices," added Ms. Johnson.
>>> "These guidelines provide that information."
>>>
>>>
>>>
>>> ILADS is a nonprofit, international, multidisciplinary medical
>>> society dedicated to the appropriate diagnosis and treatment of Lyme
>>> and associated diseases.
>>>
>>>
>>> For more information:
>>>
>>> www.ilads.org<http://ilads.us8.list-manage.com/track/click?u=618a478
>>> 0f78630b439260ac0a&id=52166ff08d&e=bd3361534c>
>>>
>>> Facebook<http://ilads.us8.list-manage2.com/track/click?u=618a4780f78
>>> 630b439260ac0a&id=1a51419f4c&e=bd3361534c>
>>>
>>>
>>>
>>>
>>>
>>> Copyright © 2014 International Lyme and Associated Disease Society,
>>> All rights reserved.
>>> You are receiving this because you attended or requested information
>>> about our conferences or to support the fight against Lyme Disease.
>>>
>>> Our mailing address is:
>>> International Lyme and Associated Disease Society PO Box 341461
>>> Bethesda, MD 20827-1461
>>>
>>> Add us to your address
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