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Control in rehabilitation research

The essence of a randomized, controlled intervention study is that one group of people who receive a particular action or set of actions is compared with another group who receive an alternative action or set of actions. When the ‘action’ is delivery of a specific drug that can be completely isolated, establishing control is easy using an identical preparation that simply lacks the active ingredient. For complex, multifactorial interventions such as surgery or rehabilitation, establishing control is much more difficult, not least because the intervention is rarely a single specific item. Randomization cannot balance non-specific factors associated specifically with an allocated treatment; other aspects of the design need to achieve this as far as possible. To help readers decide whether control for non-specific factors has been achieved, it is important to provide accurate information about the differences in the packages received by the randomized groups of patients. This requires a systematic analysis and specific comparison of the two (or more) packages being evaluated in six domains for each intervention: its theoretical basis, the proximate goal, any assessment procedures, any associated non-specific actions, the specific actions being investigated and any contextual factors.