von Hugh MacPherson, Foundation for Traditional Chinese Medicine, York, United Kingdom

Pragmatic research has as its focus the evaluation of everyday normal clinical practice. Rather than seeking to isolate and measure the "active ingredient" of acupuncture under experimental conditions, a pragmatic randomised controlled trial is designed to assess whether acupuncture is more effective than a comparative treatment when practised in as near to usual clinical conditions as possible. The evaluation can be useful when deciding whether to add acupuncture as an additional treatment option, often in a context where there are issues of resource allocation. In this type of acupuncture trial, the control group will often receive the best of a standard or accepted treatment, while the acupuncture group will receive the full benefits that acupuncturists normally deliver utilising a range of interventions from their everyday repertoire. Instead of being designed to equalise the "placebo" effect between the two groups, as in an experimental trial, a pragmatic trial is designed to optimise the treatment effects in both arms of the trial, thereby enabling a real life comparison between benefits. The acupuncturists can optimise their treatments by adapting them to match their patient’s individual configuration of symptoms and lifestyle, a normal feature of acupuncture when practised according to the principles of traditional Chinese medicine. The priority therefore is good external validity, with practical relevance and generalisability to normal treatment delivered by a specified population of practitioners.

As an example of pragmatic research, I will present the NHS funded York Acupuncture Back Pain Trial, a collaborative project with the University of Sheffield. Our goal is to evaluate the clinical gains and the cost-effectiveness of acupuncture being introduced as a referral option in primary care. This is a real world context, where existing clinical guidelines for general (family) practitioners do not include referral of patients with low back pain for acupuncture. The acupuncturists, all members of the British Acupuncture Council, are providing the patients in the treatment group with acupuncture, as they would normally practice it. The acupuncturists aim to optimise their patients’ involvement in the recovery process, helping them make sense of their condition from the perspective of Chinese medicine and engaging in dialogue that supports more fundamental change. In other words, the treatment process can, if the patient is willing, involve a much deeper process of healing than a "technical fix". Patients in the control group will continue to receive normal primary care management. A raft of outcomes, both clinical and economic, are being assessed at 3 and 12 months. Patient interviews are expected to provide depth to the understanding of the patient’s experience of acupuncture. This trial has been running for eighteen months and we are now near to achieving our recruitment target of 240 patients. Soon we will be reporting on how acupuncture compares when practised optimally in a real world setting.