Developing a Handbook for Developing Clinical Care Protocols in Cancer Management. Part II: Steps for Protocol Elaboration. A systematic review.

Article type
Authors
Vallejo-Ortega M1, Sánchez R1, Feliciano-Alfonso JE1, Gutierrez MP1, Merchán RA1
1Instituto Nacional de Cancerología
Abstract
Background: Clinical care protocols (CCPs) are similar to clinical practice guidelines (CPGs); however, there is not enough information about how to develop CCPs for improving quality of care in cancer. Therefore, it is required to determine the necessary steps for its elaboration as well as how they differ from CPGs development.

Objective: To establish the necessary steps for systematic development of CCPs.

Methods: A systematic search was performed in order to find the documents related to the development of CCPs using the following sources: CPGs developers´ websites, electronic databases, Google and Google scholar without date restriction. The documents must have established the steps required to make CCPs and must have defined CCPs as “detailed instructions about how to do a specific health care activity” for inclusion. The quality tool was developed by the researchers in a concerted way. Finally, two independent reviewers made the selection, extraction, and quality assessment of the evidence. Discrepancies were resolved through discussion.

Results: We found 6425 documents, 15 of them were eligible but we included 13 of these which described 11 methodologies. Retrieved documents were developed from 1996 to 2013 and their global quality was intermediate. We found that the necessary steps for protocol development were: prioritisation of topics; definition of scope and objectives; evidence search, selection, appraisal and synthesis; elaboration of flowcharts; writing the report; and, CCPs implementation and update. Noteworthy, there was scarcity of knowledge about CCP’s question formulation, evidence contextualisation and CCPs implementation. In addition, CCPs documents differed form CPG in that CCPs focused on flowchart making and report standardisation.

Conclusions: CCPs steps are similar to CPGs development, but the CCPs documents have less-detailed information than CPG’s handbooks. Our findings highlight not only the need to create a more-detailed CCPs handbook but also to validate strategies to contextualise evidence and implement CCPs indications, especially in cancer management.