Process evaluation questions and methods for evaluating
| Component | Process evaluation questions | Research methods | Stage of study to collect data |
| Recruitment of sites and rehabilitation teams | How are sites and teams recruited? | Documentation of recruitment process by research team. | Preintervention |
| Which sites and teams agree to participate? | Quantitative comparison of recruited and non-recruited sites. | ||
| Response of rehabilitation teams | How is the enhanced intervention adopted by the rehabilitation teams? | Quantitative examination of case report forms and qualitative interviews of rehabilitation team members. | During and following the intervention |
| Recruitment and reach in patient and carer participants | How many are recruited into the feasibility study? Are they representative? | Quantitative comparison between feasibility study and anonymised cohort. | During the intervention |
| Who is recruited into the feasibility study? What are the reasons for non-recruitment? | Examination of recruitment log. | During the intervention | |
| Intervention delivery | What rehabilitation intervention is delivered? Is it what was intended by the researchers? | Quantitative examination of case report forms and of electronic data entered onto Therapy Manager software. | During the intervention |
| Delivery to individuals | What intervention is delivered to each participant? | Quantitative examination of case report forms and of electronic data entered onto Therapy Manager software. | During the intervention |
| Is the delivered intervention the one intended by the researchers? | Measurement of intervention fidelity: completion of workbook tasks, completion of diaries and number and content of therapy sessions. | During the intervention | |
| Response of individual patients to the enhanced intervention or usual rehabilitation | How do the patient participants respond? | Qualitative analysis of focus group data about patient participants’ experience and response to the intervention and to usual care. | Following the intervention |
| Response of carer participants | Effects on carers. | Qualitative analysis of focus group data about carers’ experiences. | Following the intervention |
| Unintended consequences | Are there unintended changes in processes and outcomes related to the intervention and unrelated to care? | Quantitative examination of adverse effects reports, health service activity data from patient completed questionnaires and routinely collected electronic sources. Qualitative analysis of focus group data from patients and their carers. | During and following the intervention |
| Theory | What theory has been used to develop the intervention? | Quantitative data analysis of process outcome measures to assess predicted relationships. | Following the intervention |
| Context | What is the wider context in which the feasibility study is conducted? | Realist review of the rehabilitation literature, survey of current rehabilitation practice, focus groups of patients, carers and rehabilitation professionals. Quantitative comparison with anonymised cohort. | Preintervention (phase I study) and during the intervention |