HL Deb 10 March 2004 vol 658 cc179-80WA
The Countess of Mar

asked Her Majesty's Government:

Further to the Written Answer by the Lord Warner on 26 February (WA 76), why the entry criteria for the two PACE trials have not been finalised when the criteria have been specified on the Medical Research Council website as "Oxford criteria"; whether these criteria are to be used for the PACE trials; and whether there are alternatives; and [HL1702]

Whether the contracts for the two PACE trials have been awarded; and, if so, to whom; and what are the start and completion dates for each of the trials. [HL1703]

Lord Warner

The Medical Research Council announced funding in May 2003 for two trials which will look at the effectiveness of various treatments for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). The first trial is known as PACE (Pacing, Activity and Cognitive behaviour therapy: a randomised Evaluation). PACE will be led by Dr Peter White at St Bartholomew's Hospital in London, Dr Michael Sharpe of the University of Edinburgh and Dr Trudie Chalder of King's College London.

The second trial, known as FINE (Fatigue Intervention by Nurses Evaluation) will test two different treatments that are particularly suited to those who are too ill to attend a specialist clinic. FINE will be headed by Dr Alison Wearden at the University of Manchester.

Once an application for funding has been approved, preparations need to take place. These include discussions of practical arrangements with the trial centres, recruitment and training of the staff needed to run trials, and obtaining final approval of the trial protocol by ethics committees. The current estimated start of recruitment of patients into both trials is the summer or autumn of 2004. They are expected to take up to five years to complete.

Entry criteria were originally proposed in the applications for funding. Final confirmation of the criteria by the multicentre research ethics committee is expected by May 2004. Unconfirmed criteria for both trials are that participants will: meet the Oxford diagnostic criteria for CFS; score four or more on the eleven-item Chalder fatigue scale; score less than 75 per cent on the Medical Outcomes Study Short Form (SF-36) physical functioning scale. Both trials will also collect and compare data relating to other internationally accepted diagnostic criteria.

All participants will provide informed consent, will be of either gender, and will be aged at least 18 years old. For PACE, participants will be attending one of six specialist CFS services in the United Kingdom. Participants in FINE will be in primary care and the trial is expected to involve severely affected patients, including those who are bed or house-bound and who may not be able to take part in other treatments that require hospital or clinic attendance.