IDSA Lyme Guidelines (2006) WITHDRAWN from NGC

General or non-medical topics with information and discussion related to Lyme disease and other tick-borne diseases.
dlf
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Joined: Sun 7 Apr 2013 15:36

Re: IDSA Lyme Guidelines (2006) WITHDRAWN from NGC

Post by dlf » Sat 27 Feb 2016 17:46

In response to ChronicLyme19's question:
So is there an actual requirement by the IOM to publish a summary/summary response of the public comments?
The simple answer is no, there is no such requirement by the IOM. That was not why the IDSA intended on publishing a summary response to the public comments. As Lorima pointed out there is no enforcement of IOM standards and the IDSA proceeds on the basis that the IOM recommendations are beneath their consideration. They operate based entirely on their own rules.

Here is the shortened version of the IOM report that contains the standards:

http://iom.nationalacademies.org/Report ... dards.aspx

So, why would the IDSA offer to publish the summary response to the public comments period?

Well, (to me), it would seem that they were trying to establish that certain principles were followed that ARE mandated by their own rules and processes. They need to show compliance with their own less stringent regulations, and so far they don't seem to be able to do even that.

Their intention of posting the summary response to the public comments statement was in the original announcement for the opening of the public comments period put out by the IDSA back in March 2015. So, this summary response and the publication of a timeline and for the availability of the draft for an additional public consultation was a stated intention right from the start. Some form of stakeholder involvement and transparency was likely necessitated by the IDSA Lyme guidelines project process because all guidelines issued by the IDSA must adhere to their own Handbook on Clinical Practice Guidelines Development which does specifically state that to help ensure that its guidelines are of sound quality that the IDSA looks to the AGREE framework to assess rigor and transparency.

http://www.idsociety.org/uploadedFiles/ ... 010.15.pdf

AGREE is very clear on the need for stakeholder involvement and the final guidelines when put to evaluation for compliance to AGREE need to show that they have undertaken certain steps with regard to stakeholder involvement.

http://www.agreetrust.org/wp-content/up ... E_2013.pdf

While not directly stated as an obligation, if the IDSA fail to provide stakeholder involvement and transparency with regard to the guidelines, by their own rules for guidelines development they will suffer loss of credibility from not meeting compliance with the AGREE standards. I think the public comment periods and the offer of transparency on the summary response and the availability of the draft for a further public comment period were the IDSA means to ensure compliance with AGREE. The applicable sections seem to be DOMAIN 2. STAKEHOLDER INVOLVEMENT and RIGOUR OF DEVELOPMENT. I have copied both sections below, but the original project process itself was lacking details about the needed external review step. If the second public consultation after the draft guidelines was intended to be their external review, then it is premature to determine whether this review would fulfill the needed criteria. That could only be determined after that stage was completed.
DOMAIN 2. STAKEHOLDER INVOLVEMENT
4. The guideline development group includes individuals from all
relevant professional groups.
5. The views and preferences of the target population (patients, public, etc.)
have been sought.
6. The target users of the guideline are clearly defined.

STAKEHOLDER INVOLVEMENT
5. The views and preferences of the target population (patients, public, etc.) have
been sought.

User’s Manual Description:
Information about target population experiences and expectations of health care should inform the
development of guidelines. There are various methods for ensuring that these perspectives inform the different
stages of guideline development by stakeholders. For example, formal consultations with patients/public to
determine priority topics, participation of these stakeholders on the guideline development group, or external
review by these stakeholders on draft documents. Alternatively, information could be obtained from interviews
of these stakeholders or from literature reviews of patient/public values, preferences or experiences. There
should be evidence that some process has taken place and that stakeholders’ views have been considered.


Where to Look:
Examine the paragraphs on the guideline development process. Examples of commonly labeled sections or
chapters in a guideline where this information can be found include: scope, methods, guideline panel member
list, external review, and target population perspectives.

How to Rate:
Item content includes the following CRITERIA:
• statement of type of strategy used to capture patients’/public’s’ views and preferences (e.g., participation in
the guideline development group, literature review of values and preferences)
• methods by which preferences and views were sought (e.g., evidence from literature, surveys, focus groups)
• outcomes/information gathered on patient/public information
• description of how the information gathered was used to inform the guideline development process and/or formation of the recommendations


RIGOUR OF DEVELOPMENT
13. The guideline has been externally reviewed by experts prior to its publication.

How to Rate:
Item content includes the following CRITERIA:
• purpose and intent of the external review (e.g., to improve quality, gather feedback on draft
recommendations, assess applicability and feasibility, disseminate evidence)
• methods taken to undertake the external review (e.g., rating scale, open-ended questions)
• description of the external reviewers (e.g., number, type of reviewers, affiliations)
• outcomes/information gathered from the external review (e.g., summary of key findings)
• description of how the information gathered was used to inform the guideline development process and/or
formation of the recommendations (e.g., guideline panel considered results of review in forming final
recommendations)

Additional CONSIDERATIONS:
• Is the item well written? Are the descriptions clear and concise?
• Is the item content easy to find in the guideline?
• Are the external reviewers relevant and appropriate to the scope of the guideline? Was there a rationale given
for choosing the included reviewers?
•How was information from the external review used by the guideline development group?
User’s Manual Description: Information about target population experiences and expectations of health care should inform the development of guidelines. There are various methods for ensuring that these perspectives inform the different stages of guideline development by stakeholders. For example, formal consultations with patients/public to determine priority topics, participation of these stakeholders on the guideline development group, or external review by these stakeholders on draft documents. Alternatively, information could be obtained from interviews of these stakeholders or from literature reviews of patient/public values, preferences or experiences. There should be evidence that some process has taken place and that stakeholders’ views have been considered. Where to Look: Examine the paragraphs on the guideline development process. Examples of commonly labeled sections or chapters in a guideline where this information can be found include: scope, methods, guideline panel member list, external review, and target population perspectives.

How to Rate: Item content includes the following CRITERIA: • statement of type of strategy used to capture patients’/public’s’ views and preferences (e.g., participation in the guideline development group, literature review of values and preferences) • methods by which preferences and views were sought (e.g., evidence from literature, surveys, focus groups) • outcomes/information gathered on patient/public information • description of how the information gathered was used to inform the guideline development process and/or formation of the recommendations
Additional CONSIDERATIONS: • Is the item well written? Are the descriptions clear and concise? • Is the item content easy to find in the guideline?
Publishing the summary response to the pubic comments would have provided proof that they both consulted with the public stakeholders and considered the comments that were submitted.

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