Table 1. Context, Intervention, Mechanisms, Outcome (CIMO) framework for this study.

Context

Any health or social care service (e.g. hospital, nursing home, residential disability service) which is regulated as an organisation. This excludes services that are provided by individual professionals such as dentists or general practitioners.

Intervention(s)

Regulation is the intervention. The term ‘regulation’ may differ in a given context but it is generally taken to mean a process of external evaluation by an independent or statutory agency which is underpinned by enforcement powers.

Mechanism

Factors influencing, or determinants of, compliance; barriers and facilitators to compliance; nature of engagement between regulator and regulatee.

Outcome

Main outcome: regulatory compliance. Additional outcome(s): Other measures that are consistent with compliance will be included (e.g. in the USA, equivalent terms for non-compliance may be a ‘deficiency’ or ‘violation’).