Background: Complex health care interventions are difficult to design and evaluate, so the UK Medical Research Council (MRC) has developed a 'framework for the design and evaluation of complex health care intervention'. Researchers differ in applying the framework.
Objective: To describe and critically evaluate how the two initial phases of the MRC framework facilitate the design of an integrated follow-up programme for cutaneous melanoma to a standard suitable for testing in an exploratory randomized trial. Design of study. Literature review, expert groups, semi-structured interviews and pilot exercise to develop an intervention.
Setting: A department of academic primary care. Two general practices.
Methods: Four techniques were used-iterative literature review, a steering group, semi-structured telephone interviews and an operationalization exercise. These techniques were used simultaneously and iteratively to complete the theoretical preclinical and phase I modelling of the MRC framework when developing an integrated follow-up programme for cutaneous melanoma.
Results: Components of an integrated follow-up programme for cutaneous malignant melanoma were identified, developed and refined into a practical intervention comprising GP training; structured protocol-driven appointments; a centralized recall system; a rapid access pathway and a patient information booklet. Several barriers that could have derailed the successful implementation of the intervention, including the different perspectives of stakeholders and resource needs in general practice were identified. The value of the principles of the initial two phases of the MRC framework in guiding the development of complex health care interventions was supported.
Conclusions: We recommend that the first two phases of the MRC framework be used iteratively and simultaneously when developing complex health care interventions.