BACKGROUND: Clinical pathways are tools used to guide evidence-based healthcare that have been implemented internationally since the 1980s. However, there is widespread lack of agreement on the impact of clinical pathways on hospital resources and patient outcomes. This can be partially attributed to the confusion for both researchers and healthcare workers regarding what constitutes a clinical pathway. This paper describes efforts made by a team of Cochrane Review authors to develop criteria to assist in the objective identification of clinical pathway studies from the literature. METHODS: We undertook a four-stage process aiming to develop criteria to define a clinical pathway: (1) identify publications exploring the definition of a clinical pathway; (2) derive draft criteria; (3) pilot test the criteria; and (4) modify criteria to maximise agreement between review authors. RESULTS: Previous literature and liaison with the European Pathways Association resulted in five criteria being used to define a clinical pathway: (1) the intervention was a structured multidisciplinary plan of care; (2) the intervention was used to translate guidelines or evidence into local structures; (3) the intervention detailed the steps in a course of treatment or care in a plan, pathway, algorithm, guideline, protocol or other 'inventory of actions'; (4) the intervention had timeframes or criteria-based progression; and (5) the intervention aimed to standardise care for a specific clinical problem, procedure or episode of healthcare in a specific population. After pilot testing it was decided that if an intervention met the first criteria (a structured multidisciplinary plan of care) plus three out of the other four criteria then it was included as a clinical pathway for the purposes of this review. In all, 27 studies were included in the final review. The authors of the included studies referred to these interventions as 'clinical pathways', 'protocols', 'care model', 'care map', 'multidisciplinary care', evidence-based care' and 'guideline'. CONCLUSIONS: The criteria used for the identification of relevant studies for this Cochrane Review can be used as a foundation for the development of a standardised, internationally accepted definition of a clinical pathway.