A large randomised assessment of the relative clinical and cost-effectiveness of surgery for Parkinson's disease.
The PD SURG trial was a large, pragmatic, multicentre “real-life” randomised trial to evaluate the role of surgery as therapy for PD. The fundamental question being addressed in this trial was if early surgery provides more or less effective long-term control than medical therapy with surgery deferred for as long as possible?
The main results were published in 2010:
Williams W, Gill S, Varma T, Jenkinson C, Quinn N, Mitchell R, Scott R, Ives N, Rick C, Daniels J, Patel S, Wheatley K; PD SURG Collaborators Group. Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced Parkinson's disease (PD SURG trial): a randomised, open-label trial. Lancet Neurol. 2010 Jun; 9(6): 581–591.
Further work related to this trial has also been published:
Mathers J, Rick C, Jenkinson C, Garside R, Pall H, Mitchell R, Bayliss S, Jones L. Patients' experiences of deep brain stimulation for Parkinson's disease: a qualitative systematic review and synthesis. BMJ Open. 2016;6(6):e011525.
McIntosh E, Gray A, Daniels J, Gill S, Ives N, Jenkinson C, Mitchell R, Pall H, Patel S, Quinn N, Rick C, Wheatley K, Williams A; PD SURG Collaborators Group. Cost-utility analysis of deep brain stimulation surgery plus best medical therapy versus best medical therapy in patients with Parkinson's: Economic evaluation alongside the PD SURG trial. Mov Disord. 2016.
This trial closed to recruitment in December 2006, recruiting 366 patients from 13 NHS centres across the UK. The PD SURG trial was sponsored by grants from the UK Medical Research Council and Parkinson's UK.
PD SURG was a large, pragmatic, multicentre “real-life” randomised trial to evaluate the role of surgery as therapy for PD. The fundamental question addressed in this trial was:
Does early surgery provide more or less effective long-term control than medical therapy (with surgery deferred for as long as possible)?
In order to obtain the large number of patients needed to provide reliable answers, and to maximise the clinical relevance of the findings, the trial was designed to fit in with routine practice as far as possible and to impose minimal additional workload by keeping extra clinic-based tests and evaluations to a minimum (the majority of assessments were by postal questionnaires to patients and carers).
The aims of the study were to determine reliably whether early surgery is more effective than deferred surgery for advanced PD.
Across 13 hospitals in the UK able to supply DBS surgery. The success of the trial depended entirely on the whole-hearted collaboration of many surgeons, neurologists, nurses and others.
The primary endpoint was the patient’s self-evaluation of their functional status using the PDQ-39 questionnaire.
Secondary endpoints evaluating other aspects of functioning, as well as safety, included:
- Quality of Life (EuroQol).
- Cognitive decline (Dementia Rating Scale-II)
- Clinical assessment of functioning (UPDRS, Hoehn & Yahr stage).
- Neuropsychological evaluation
- Carer psychological wellbeing (SF-36)
- Toxicity and side-effects, including mortality rates.