Wallen et al. reply

SIR–For many families it is not feasible to participate in constraint-induced movement therapy (CIMT) at intensities recommended by researchers such as Case-Smith et al.1 Similarly, the resources of some health providers are insufficient for such protocols. We sought, therefore, to implement a modified constraint-induced therapy (mCIT) intervention in usual care settings and according to an important philosophy underpinning current paediatric rehabilitation, family-centred practice. Consistent with the pragmatic2 and family-focussed orientations of this trial, participants were from a wide geographical area, multiple therapists were involved from different agencies, intervention occurred in family-selected environments and families implemented intervention with weekly support from an occupational therapist to ‘demonstrate therapy with the child and provide support/education for families in carrying out the daily intervention, as well as to upgrade the intervention as required’ and to provide evidence-based weekly home programmes.3 Co-intervention and treatment contamination are widely accepted risks associated with real-world trials. Consistent with the pragmatic orientation of this trial, occupational therapists were given written and verbal therapy guidelines which in concert with individualized outcomes derived using the Canadian Occupational Performance Measure (COPM)4 optimized uniformity of intervention. Treatment fidelity was monitored by recording occupational therapy sessions attended and the type, frequency, and intensity of intervention via a parent report log checked weekly. We speculate that families in the intensive occupational therapy group maintained a higher level of therapy between the 10-week and 6-month assessments as the family-focussed intervention, embedded into family routines, was feasible and rewarding to continue, thus sustainable. Similarly, participants in Novak et al.’s trial3 failed to cease therapy after the requisite 4 weeks as they ‘perceived the program as helpful and they considered it in the best interests of their child to continue.’ We are unapologetic about our a priori selection of the family-focussed, 10 weeks COPM4 as the primary outcome. A gap in the current evidence-base is whether constraint-based interventions improve children’s capacity to complete activities of daily living (ADL), an issue of prime concern to occupational therapists and fundamental to the World Health Organisation (WHO) International Classification of Functioning, Disability and Health. Our COPM data therefore provided new knowledge about children’s performance of priority ADLs following mCIT. Contrary to Ramey et al.’s assertion, the COPM manual recommends parent-proxy as the method for completion for children under 8 years of age.4 Parents have successfully proxy-reported in several studies of children with cerebral palsy and research has confirmed the COPM is valid, robust and sensitive to change when used in this way.5 The responsible analysis of a randomized trial involves examination of clinically important and statistically significant between group differences on the primary outcome measure at the primary end-point. The only way to determine whether the groups showed statistically significant treatment benefits, as Ramey et al. implore in their letter, is to have a no-treatment comparison. Consequently, our reporting of within-group change to assist decision-making about treatment options did not use statistical comparisons, which avoided both ‘spin’ and multiplicity. Furthermore, findings were accompanied by the proviso that the information be interpreted with consideration that a no-treatment group was not included as a comparison group. It is important to emphasize that the average increase on COPM scales at 10 weeks and 6 months was more than three points, when a change of two points is considered by test developers4 to be clinically meaningful. Our use of goal attainment scaling, which quantifies performance on priority ADLs identified by families, further reinforces the clinical importance of these outcomes. We are concerned regarding the new analyses presented by Ramey et al. in their letter comparing the Case-Smith et al.1 trial data with our own. To responsibly compare data we should know, for instance, that in Case-Smith et al.’s trial, the intervention package combined constraint with bimanual intervention, so effects of CIMT alone cannot be identified. The sample size was small and unjustified (n=18), details of severity of disability were not available for contrast with our trial and the age range was substantially smaller than ours (3–6y, 1.5–7y respectively). Variances around the point estimates, which are mandatory to facilitate scrutiny, were not provided. Finally, different versions of the Pediatric Motor Activity Log were used, rendering comparison misleading. There is no doubt that neither intervention in our study conferred an advantage over the other. Clinically important change on the primary outcome is evident. The number of trials comparing CIMT with equal intensity alternative intervention reflects the imperative identified by researchers to discern the effects of constraint from those of intensity per se.

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