The Statistical Analysis Plan for the PACE Trial [1] reported that the health economics outcomes were the CSRI (service, societal, NHS and insurance/benefits costs) and the EuroQol.

The total or sum of the insurance and welfare benefits costs i.e. those "derived by assigning costs (£) to each relevant item in the CSRI" were also listed in the plan as a secondary outcome.

However in the paper by McCrone et al. (2012) [2], these costs were excluded from the economic costs, but no reason was given for doing so. The authors still reported, in Table 4, the proportion of participants receiving these payments before and after the trial because "they are important financial outlays".

The authors concluded that "the differences between groups were not substantial" and that "with the exception of a difference between CBT and APT, there were no significant differences in either lost work time or benefits between the treatments during follow up. In fact, benefits increased across all four treatments."

Why were these important financial outlays, which apparently increased despite intensive intervention, excluded from the cost-effectiveness of these interventions?

References

1. Walwyn R, Potts L, McCrone P, Johnson AL, DeCesare JC, Baber H, Goldsmith K, Sharpe M, Chalder T, White PD. A randomised trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome (PACE): statistical analysis plan. Trials. 2013 Nov 13;14:386. doi: 10.1186/1745-6215-14-386

2. McCrone P, Sharpe M, Chalder T, Knapp M, Johnson AL, Goldsmith KA, White PD. Adaptive pacing, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome: a cost-effectiveness analysis. PLoS One. 2012;7(8):e40808