Principles of good clinical practice in thermal rehabilitation

Introduction. Thermal rehabilitation is a branch of Rehabilitation for which there is still a lack of randomized clinical trials. We opted to follow new research and to draft practical guidelines for thermal rehabilitation in Italy according to a procedure that differs from the usual one. Materials and methods. An approach recently introduced to clinical research permits better definition of clinical guidelines. The new method grades the strength of recommendations according not only to the robustness of supporting evidence but also to the opinion of a panel of experts (Delphi method). We added a third element to the two above-mentioned strategies based on identification of best clinical practice, inspired by the Good Clinical Practice (GCP) method. Results. In drafting our protocols for thermal rehabilitation therapy we therefore identified a series of general principles to apply: paradigmatic indications; costs/benefits; efficacy; harmlessness; user compliance; limits; contraindications; patient suitability; ways of accessing treatment, etc. Conclusion. It is our opinion that the identified procedure will make it easer to realistically define good clinical practice guidelines for thermal rehabilitation in Italy. The process will therefore be based on the application of standards of good clinical practice to rehabilitation treatment protocols, bearing in mind not only expert opinion and currently available scientific evidence but also the judgement of patients or their associations.