Research by Chalder et al. shows why the trick of using the Oxford criteria in the PACE trial did not work

Research by Chalder et al. shows why the trick of using the Oxford criteria ( so that patients could be included who do not have the disease, ie including patients with depression and other psychiatric disorders and not ME/CFS) in the ME/CFS PACE trial did not improve outcomes ie did not work

@ BMJ:

Research
Facilitated physical activity as a treatment for depressed adults: randomised controlled trial BMJ 2012; 344 doi: http://dx.doi.org/10.1136/bmj.e2758 (Published 06 June 2012) Cite this as: BMJ 2012;344:e2758 * Melanie Chalder, research fellow1 , * Nicola J Wiles, senior lecturer1 , * John Campbell, professor2 , * Sandra P Hollinghurst, senior lecturer1 , * Anne M Haase, senior lecturer3 , * Adrian H Taylor, professor4 , * Kenneth R Fox, professor3 , * Ceire Costelloe, research associate1 , * Aidan Searle, research associate1 , * Helen Baxter, research associate1 , * Rachel Winder, associate research fellow2 , * Christine Wright, associate research fellow2 , * Katrina M Turner, lecturer1 , * Michael Calnan, professor5 , * Deborah A Lawlor, professor1 , * Tim J Peters, professor6 , * Deborah J Sharp, professor1 , * Alan A Montgomery, reader1 , * Glyn Lewis, professor1 Author affiliations *
Correspondence to: M Chaldermelanie.chalder@bristol.ac.uk *

Accepted 22 March 2012

 Abstract
Objective To investigate the effectiveness of facilitated physical activity as an adjunctive treatment for adults with depression presenting in primary care.

 Design
Pragmatic, multicentre, two arm parallel randomised controlled trial. Setting General practices in Bristol and Exeter. Participants 361 adults aged 18-69 who had recently consulted their general practitioner with symptoms of depression. All those randomised had a diagnosis of an episode of depression as assessed by the clinical interview schedule-revised and a Beck depression inventory score of 14 or more.

Interventions
In addition to usual care, intervention participants were offered up to three face to face sessions and 10 telephone calls with a trained physical activity facilitator over eight months. The intervention was based on theory and aimed to provide individually tailored support and encouragement to engage in physical activity.

 Main outcome measures
The primary outcome was self reported symptoms of depression, assessed with the Beck depression inventory at four months post-randomisation. Secondary outcomes included use of antidepressants and physical activity at the four, eight, and 12 month follow-up points, and symptoms of depression at eight and 12 month follow-up.

 Results
There was no evidence that participants offered the physical activity intervention reported improvement in mood by the four month follow-up point compared with those in the usual care group; adjusted between group difference in mean Beck depression inventory score −0.54 (95% confidence interval −3.06 to 1.99; P=0.68). Similarly, there was no evidence that the intervention group reported a change in mood by the eight and 12 month follow-up points. Nor was there evidence that the intervention reduced antidepressant use compared with usual care (adjusted odds ratio 0.63, 95% confidence interval 0.19 to 2.06; P=0.44) over the duration of the trial. However, participants allocated to the intervention group reported more physical activity during the follow-up period than those allocated to the usual care group (adjusted odds ratio 2.27, 95% confidence interval 1.32 to 3.89; P=0.003).

 Conclusions
The addition of a facilitated physical activity intervention to usual care did not improve depression outcome or reduce use of antidepressants compared with usual care alone.

Trial registration Current Controlled Trials ISRCTN16900744