Table 2 Actions to inform and document the content of usual care

Identify context drivers — gather data

 Characterise and document existing practices

  • Understand, appraise and document existing practices

  • Include institutions participating in the study in the characterisation of current practices

  • Establish whether potential trial participants can access existing practices and how they currently manage the target problem

 Know current clinical guidance

  • Identify and read relevant best-practice guidelines

Make a decision — balance objectives and agree trade offs

 Assess existing practices

  • Consider the extent to which existing practices are evidence-based and vary between trial sites

  • Consider whether the usual care arm will contribute to meaningful inferences about the experimental intervention

  • Consider the extent to which existing practices overlap with the experimental intervention

  • Compare existing practices to the experimental intervention in terms of intensity and duration

  • Consider the extent to which existing practices at each trial site reflect national or community standards

  • Acknowledge disagreements about what usual care involves and identify source of disagreement

 Consider alternative comparators

  • Consider advantages and limitations of usual care controls compared to alternative comparators

  • Develop criteria to review possible comparators

  • Discuss alternative comparators with policymakers and providers to establish which would be most meaningful and acceptable to them

 Think context and the needs of the trial

  • Question whether a minimum level of treatment is needed, according to clinical guidelines

  • Think systematically about the background conditions in the practising medical community and goals of the trial

  • Consider the need for internal and external validity

  • Acknowledge practical limitations, e.g. infrastructure, costs, time

Detail the outcome — document the decision and monitor use of usual care

 Detail the decision-making process

  • Document the information and the decision-making process used to decide the content of usual care

 Monitor usual care

  • Develop methods to monitor usual care and track participants’ use of usual care in the trial