GUIDELINES | | Year : 2008 | Volume : 3 | Issue : 6 | Page : 60-61 | | The process of guideline development | | Abdul-Rahman Jazieh King Abdulaziz Medical City for National Guard, Riyadh, Saudi Arabia Correspondence Address: Abdul-Rahman Jazieh Department of Oncology (Mail code 1777), King Abdulaziz Medical City for National Guard, P.O. Box 22490, Riyadh 11426 Saudi Arabia
| | Abstract | | | Delineating the process of guidelines is the fundamental step that should be agreed upon prior to working on the details of the guidelines. The Lung Cancer Guideline Committee agreed on the process described below in order to develop framework of the Committee. Experiences of other organizations in developing guidelines have been taken into consideration.
Keywords: Lung Cancer, process, guidelines How to cite this article: Jazieh AR. The process of guideline development. Ann Thorac Med 2008;3:60-1 | The process of creating clinical guidelines is a complicated and challenging task that requires interdisciplinary teamwork. This manuscript presents the steps involved in creating lung cancer guidelines by the Lung Cancer Guidelines Committee.
Forming the Guideline Committee | | |
A committee was formed involving expertise from various institutions in the Kingdom of Saudi Arabia, including thoracic surgeon (three members), oncologist (three members), radiation oncologist (three members), pathologist (two members), medical imaging physician (one member) and pulmonary physician (one member).
The committee members represented the Saudi Oncology Society and the Saudi Thoracic Society and various major institutions and geographical regions.
Delineating the Process | | |
The committee initially agreed on the following points in creating the guidelines:
- Adopting a bulleted format flow and avoiding the flow chart format. The format will address each stage separately with minimal referral to other sites to facilitate the ability to follow the instructions.
- The process should be systematic for common scenarios. The process will follow logical steps and sequence of events. The guidelines will focus on the frequently encountered clinical situations and avoid rare ones (those that are less than 5% of the cases).
- The content and flow of information should be evidence based and comprehensive in order to have credibility and be applicable to a wider base of practitioners.
- Determining the categories of evidence level (EL). In order to create evidence-based guidelines in a consistent manner, the committee decided to determine the category of evidence similar to internationally accepted categories.
The Algorithm Flow | | |
The committee agreed to the following process flow steps:
Diagnosis → Preparatory stage → Decision-making point → Decision → Evaluate outcome → Subsequent decision → Evaluate subsequent outcome → Closing decision.
Preparatory stage: Includes all the diagnostic workup and data required to reach a decision-making point.
Decision-making point: The point when an action must be taken based on the available data. The physician may have more than one path to follow.
Closing decision: The final recommendation in the algorithm process, which includes palliative care or end of life care, enrollment in clinical trial and follow up/surveillance.
The recommendations should address the following five points, in order, as much as possible [1] :
- Confirming the diagnosis: This is a mandatory step before taking any major decision. Adequate specimen resulting in proper pathology report is very crucial.
- Determining the proper stage of the disease: It is a fundamental step for the treatment decision in addition to being important for prognosis.
- Offering curative treatment whenever possible: The main goal and the ultimate outcome for any treatment is to provide therapy that eliminates the disease and cures the patient and helps him live disease free.
- If cure is not attainable, offer the best approach to help the patients that could prolong survival or symptoms control and palliation.
- Encouraging participation in clinical trials: As many questions remain unanswered and the outcome is poor in lung cancer, clinical trials should be encouraged.
The Format | | |
The committee agreed on using a numbering format, which is important, as it will be easy to link sections to each other in the process. This format will include:
- Guidelines: Keeping the above algorithm flow in mind, the guidelines should cover diagnosis and initial evaluation workup, staging workup, then initial treatment, surveillance, relapse treatment and then final recommendation.
- Manuscripts have to include:
2.1. Reviewing the literature and the evidence to support recommendation.
2.2. References.
Categories of Evidence | | |
Members agreed to adopt international data until strong local data are available.
The following ELs were adopted:
- (EL-1) High level: Well-conducted phase III randomized studies or metaanalysis.
- (EL-2) Intermediate level: Good phase II data or phase III trials with limitations.
- (EL-3) Low level: Observational/retrospective study/expert opinion.
All recommendations that carry risk for the patient, or have an economic impact, should be justified and categorized by the EL.
Published international guidelines such as the National Comprehensive Cancer Center (NCCN), the American College of Chest Physician (ACCP) and the American Society of Clinical Oncology were taking into consideration. [2],[3],[4]
Finally, the committee decided to recommend the best guidelines supported by the evidence, not taking into consideration the economic factors and the availability of certain drugs, procedures or equipment. The decision was made to maintain the scientific integrity of these guidelines and encourage healthcare professionals and organizations to adhere to them. The committee understands that institutions may develop their local clinical pathways according to their situations; however, the committee decided to maintain the guidelines at the highest possible standard of care. References | | | 1. | Jazieh AR. The principles of oncology practice: Back to basics. Am J Clinical Oncol 2008 In press. | 2. | NCCN Guidelines. Available from: http:′′www.NCCN.org, 2008 | 3. | American College of Chest Physicians Guidelines. Chest 2007;132:1-422. | 4. | Pfister PG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker S Jr, et al . American Society of Clinical Oncology treatment of unresectable non-small cell lung cancer guidelines: Update 2003. J Clin Oncol 2004;22:330-53. | | |
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