Background:

The development process for clinical practice guidelines (CPG) is complex, involving several steps, including a validation step. Thus the process necessarily takes time, so that when a CPG is published the evidence on which it is based can be 1 to 2 years out of date, which can be detrimental in terms of the quality and validity of the CPG. However, it is not feasible to continually include data, particularly in a particularly active area, because the development will never be finished. We describe here a method for literature monitoring we used during the development of CPG for first-line palliative chemotherapy in patients with metastatic colorectal cancer.

Objective:

The objective of this study was to assess the feasibility and impact of literature monitoring during the development of a CPG.

Methods:

In March 2002, the process for updating CPG for first-line palliative
chemotherapy in patients with metastatic colorectal cancer was initiated. The initial literature search for this update identified meta-analyses, systematic reviews, CPGs and randomised clinical trials (RCTs), comparing palliative chemotherapy with best supportive care or no chemotherapy, or comparing different drugs or regimens. We then set-up a literature monitoring process to continue searching for the same type of evidence up to the final validation step (November 2003). This process was performed using the OVID alert process for MEDLINE and information from members of the guideline development group. We also searched the Cochrane Colorectal Cancer Group s production and the Internet sites of organisations producing CPGs. Abstracts identified by the members of the working group were included only if these contained updated information for previously identified meta-analyses, systematic reviews, CPGs or RCTs.

Results:

The literature monitoring process retrieved 1 CPG, 1 meta-analysis, 10 full reports of RCTs and 2 abstracts of RCTs. The meta-analysis was an update of one previously included, with important new data. Seven of the 10 full reports of RCTs corresponded to RCTs previously identified as abstracts; the other 3 were new RCTs. One of the abstracts retrieved reported updated results for an RCT previously published as a full report in 2003, and the other corresponded to additional results for an RCT previously published as an abstract. For this latter abstract, some of the members of the working group knew that the full report was in press. These references identified by monitoring represent 13.5% of the new references, and 15% of the clinical trials included in the updated CPG.

Conclusions:

Our analysis demonstrates the feasibility of literature monitoring during the CPG development process. In this example, it allowed important data to be incorporated into the final guideline. It has been estimated that about 10 phase III RCTs have been published annually between 1999 and 2003 for this topic. However, for other guidelines, where the number of RCTs published annually is lower, the yield may be lower, and therefore the impact on the final CPG not so high.