Single Patient Open Trials (SPOTs)

Abstract

Single patient open trials (SPOTs) are nearly identical to standard trials of treatment. The added essential ingredient is a set of symptoms (commonly arrived at by negotiation between clinician and patient) to monitor (the outcome measures). This means they lie somewhere in between formal N-of-1 trials and totally informal trials of treatment in terms of rigour. SPOTs are accordingly less demanding to arrange (for both the patient and clinician) than N–of-1 trials, but they require considerably more effort and commitment than casual trials of treatment. This chapter defines and describes the rationale for SPOTs, discusses when and why they could be used, as well as their limitations, and describes outcome measures and analysis. As well as describing the use of SPOTs in clinical contexts, it covers the extra considerations required when using SPOTs in research. Several examples of the practical application of SPOTs are given, some with the resulting data. It is anticipated that the examples may be adapted to enable other clinicians and their patients to perform their own SPOTs to validate other medical interventions in the context of the individual.