Question 15

College Answer

1. Form a multidisciplinary team including medical, nursing and haematology/blood bank staff to help you prepare the guideline.
2. Review current guidelines of your unit if available. Review the date of publication of those guidelines and times of updates.
3. Audit the indications and volume of transfusions in your ICU.
4. Review the current literature for packed cell transfusion. In particular review any statements or guidelines form national blood bank authority or professional bodies. In the absence of strong evidence, expert opinion is available in these statements.
5. Determine the relevance of the current literature to you case mix – e.g. transfusion threshold for stable post cardiac surgical patients are important.
6. Prepare a draft guideline and circulate widely including to ED/ theatres / haematology.
7. Review comments and issues raised after circulating draft guidelines.
8. Prepare final guideline and circulate and publish for use in your ICU.
9. Plan to monitor compliance with these guidelines.
10. Date for future review.

Discussion

In brief, guideline development should consist of the following key stages:

• Define the process which requires a practice guideline
• Compose a panel of experts and stakeholders, and nominate its leader
• Develop the questions answered by the guideline
• Develop selection criteria for the published evidence
• Perform a literature search according to these criteria
• Appraise the evidence, extract data from it, and synthesise recommendations
• Draft guidelines, and expose the draft to external review
• Publish the final draft
• Monitor adherence and uptake
• Audit the practice to monitor outcome changes associated with the new guidelines
• Prepare scheduled updates

Identify the practice

• A need for review is identified, and the department manager approves of this.
• The specific area is defined as a practice policy or work process which requires a protocol to standardise practice,  improve outcomes or prevent adverse events.
• An existing guideline or policy may be in need of revision

Compose the guidelines panel

• Key stakeholders form a multidisciplinary working party .
• A multidisciplinary approach is called for which involves consumers
• The working part appoints a Team Leader (or, one if appointed from the top down)
• Timeframes are identified, as to how long it should take to create the policy, and the mandatory review period (for the next time this policy needs to be updated)
• A schedule of meetings is drawn up, with key dates for completion of policy drafts and other important time intervals in the process

Identify the question

• The purpose and scope of the guidelines is clearly defined
• Specific questions are determined, eg. "Should any specific haemoglobin concentration trigger a mandatory transfusion?"
• The target audience for the guidelines is defined
• Specific health outcomes are defined, which the guideline should address

Develop research strategies

• Evidence selection criteria are developed
• A literature search is performed with the abovementioned criteria. If possible, a systematic literature review should be undertaken.
• The evidence is reviewed and critically appraised
• Data relevant to the guideline is extracted and presented for the working party to assess
• The working part develops a series of recommendations according the the presented data
• Other similar policies and guidelines from other institutions are explored and useful material is borrowed or adapted
• A cost analysis is performed and the cost of the new policy is compared to that of existing practice
• Possible barriers to implementation  are considered
• A draft of the guideline is generated

Specific features and properties of the guidelines document

• A good guidelines statement should:
  • Identify the organisation responsible
  • Define the purpose of the guideline
  • List individuals and groups responsible for its development
  • Document clearly the process of evaluation of the evidence
  • Provide a bibliography
  • Detail the assumptions
  • Record public policy and economic questions which were considered
  • Identify the need for special training required for implementation
  • Record how consumer concerns were taken into account
  • Detail methods for dissemination
  • Detail the timeframe for evaluation

Recursive improvement

• The draft is widely circulated
• Key personnel outside the working panel are nominated to critique the draft
• Consideration is given to suggestions and commends on the draft, and by recursive improvement a final draft is created which is approved by all key stakeholders.
• The final draft is then framed in a pre-defined publication format for thematic consistency with other existing guidelines
• The final product is submitted for approval by the department manager.

Implementation

• Roll-out occurs on a previously specified date, of which all key audiences are made aware well in advance.
• The final policy is then widely circulated. Alternatively, the guidelines may be piloted in pre-specified locations or scenarios before wirder circulation.
• Internal and external education sessions are held to update staff on the new practice
• Guideline documents are made accessible
• Contact is made with educators, to act as ‘champions’  to promote the guideline
• Experts are made available for contact and questions

Audit and quality assurance

• Repeated data analysis and collection should be carried out after the guidelines are disseminated and implemented.
• Guideline dissemination efficacy, uptake and adherence by practitioners, consumer satisfaction and health outcomes are possible data to be collected for audit.
• Auditors are nominated from departments to implement this policy monitoring processes
• The auditing team creates short-term and long-term frameworks for evaluation and identifies who will conduct the studies.
• Regular meetings are scheduled by the auditors to monitor compliance and to feed back on the implementation process

Revision

• A multidisciplinary group not unlike the one which developed the guidelines should meet regularly to determine whether new evidence needs to be incorporated.
• The group should review research strategies of the original group, and improve on the process where possible
• Outcomes and recommendations arising from audit activity should be incorporated into the revision process

Moulding, Nicole Therese, C. A. Silagy, and D. P. Weller. "A framework for effective management of change in clinical practice: dissemination and implementation of clinical practice guidelines." Quality in Health Care 8.3 (1999): 177-183.

Schünemann, Holger J., Atle Fretheim, and Andrew D. Oxman. "Improving the use of research evidence in guideline development: 1. Guidelines for guidelines." Health Research Policy and Systems 4.1 (2006): 1.

Silagy, C., et al. "A guide to the development, implementation and evaluation of clinical practice guidelines." National Health and Medical Research Council, Canberra, Commonwealth of Australia (1998): 1-79.