Development of Clinical Practice Guidelines in the Field of Pain

Objective: IASP to develop guidelines for clinical practice in order to provide members with evidenced-based information for rational and best practice.
 
Background: Practice guidelines represent formalized reviews of the existing literature on a given topic, which serve as a background for evidence-based practice recommendations. The literature review is a systematic, unbiased and transparent presentation of the evidence. Expert panels scrutinize available literature on a given topic, present evidence based on quality of studies, and recommend guidelines for best clinical practice. The development of a guideline should follow a specific scheme:

1. Ask a clinically relevant question
2. Analyze all available evidence objectively
3. Make conclusions
4. Formulate recommendations

Audience: Members of IASP and other healthcare providers including patient organizations dealing with clinical pain.

Areas for practice guideline:
Clinical practice management: i.e., a series of specific evidence-based recommendations for handling a specific clinical situation/condition.
New technology or treatment: i.e., evidence-based recommendations for new therapies or technologies in the pain area assessing utility, safety and effectiveness.

Proposal for topics: Any member of IASP or any other health organization may submit a proposal for the development of a guideline on a certain topic. The proposal should contain the following:
a) Outline of problem, b) relevance to pain, c) impact of condition (individual/society), d) degree of practice variation, e) current evidence and its quality, f) have previous guidelines been developed or published related to the topic, and g) the benefit of a new guideline.  The proposal should also include a budget proposal and business plan for funding the guideline development.

IASP will convene a review panel to determine if the topic is accepted for development of a guideline.

Who prepares the guidelines:
The IASP review panel upon acceptance of a proposal assigns a specific person who will be responsible for assembling a task force of 5-10 persons to develop and author the guideline. Care should be taken to avoid any sort of bias and to ensure diversity of members of the panel (geographically and in terms of discipline). Members should have recognized expertise in the area (e.g. authored clinical publications in prestigious journals). In certain circumstances it will be necessary to include non-IASP members in the task force. In case of a conflict of interest, it is important to balance such by having task force members with and without conflicts of interest. Any conflict of interest will be disclosed in the guidelines. Certain guidelines may prepared together with other organisations e.g. WHO.

The IASP Review Panel approves the task force. The guideline proposal and the task force/author panel are communicated to the Cochrane Group to ensure mutual information.

The IASP staff shall assist with administrative support, facilitation of meetings and communication via a discussion forum; IASP may/should also provide economic support to the task force.

Development plan for a guideline

1. The clinical question
   1. Population: what type of pain group involved.
   2. The type of intervention (treatment/diagnostic procedure) the person is exposed to.
   3. Outcome should be a clinically relevant one, e.g. pain reduction. Surrogate markers such as a radiological measure should be avoided.
2. Terms and databases
   1. Search terms, e.g., MeSH words for Medline search are helpful.
   2. Databases. These usually include MEDLINE, EMBASE and SCI. In certain cases, additional databases may be needed and a medical librarian may be helpful in assisting here.
3. Inclusion and exclusion criteria of literature
   1. The task force develops criteria for including and excluding articles. This is a crucial element and may differ from one topic to another.
   2. Subjects (in general only human studies).
   3. Intervention should be clear.
   4. Type of studies. If the literature is large, only class I studies are examined. If the literature is limited, studies from lower classes may be used. Only studies from peer-reviewed journal should be included.
4. A time line showing major milestones and projected guideline completion dates.

The task force submits the plan for the guideline development to the appointed individual for the guideline, who may revise as necessary.  IASP staff allocate resources for the project.

Data review and analysis

1. Literature search.
2. Evaluate the quality and accuracy of the search (the full paper should be read (not only the abstract)).
3. Collection of previous meta analyses should always be done.
4. Collection of reviews/overview is done from databases.
5. Scientific.

Evidence can be presented for a therapeutic and a diagnostic procedure 

1. Evidence for a therapeutic intervention.

Comparison (control group).
Treatment allocation.
Completeness of follow-up, including drop out rate.
Masking in the study (investigator unaware of original treatment assignment  should determine the outcome).

1. Evidence for a diagnostic procedure.

Comparison (control group).
Study design.
Patient spectrum.
Valid reference standard (independent of the diagnostic test in question).
Completeness.
Masking in the study (investigator unaware of diagnostic test should apply the reference standard to determine the true presence of the outcome).

Conclusion and recommendations
Summarize the evidence to the clinical question
Divide recommendation into categories: Level A, B, and C ratings
Consider recommendation for developing and developed countries
IASP should follow-up on value/impact of guideline
Guidelines authorized for a limited period (e.g. until new evidence emerges)

Guideline format
Title: IASP Guidelines on …….. Report of an IASP Task force on…..
Abstract
Introduction
Analytical process
Analysis of evidence
Conclusion
Recommendations
Future research
Tables, algorithms, figures
Conflict of interest
References
 
Review process:
The written guidelines should conform to the style of PAIN. The length of the guideline should aim to not  exceed 3000 words. The Task Force submits the guidelines to the Review Panel for IASP endorsement and to PAIN for possible publication.  IASP will also post the final guideline on its website and make it available to the public.

Supplementary material and literature:
Sackett, D L et al. Evidence-Based Medicine: How to Practice and Teach EBM.
New York: Churchill Livingstone.1997
Hughes RAC et al. Guidance for the preparation of neurological management guidelines by EFNS scientific task forces. Eur J Neurol 2001; 8:549-550.
Brainin M et al. Guidance for the preparation of neurological management guidelines by EFNS scientific task forces revised recommendations 2004. Eur J Neurol 2004; 11:577-581.
American Academy of neurology Clinical Practice Guideline Process Manual 2004 Edition http://www.aan.com/go/practice/guideline
www.jameslindlibrary.org
www.guidelines.gov
www.cochrane.org