Objectives | Outcome measures | Data source |
---|---|---|
1. Rates of recruitment and retaining participants through the trial | The number of patients listed for TKA surgery | Screening logs |
Study CONSORT diagram (screening) | ||
Number of patients recruited (giving consent) and | Recruitment logs | |
Study CONSORT diagram (randomisation) | ||
Number completing follow-up 1 | Recruitment logs | |
Study CONSORT diagram (follow-up 1) | ||
Number completing follow-up 2 | Recruitment logs | |
Study CONSORT diagram (follow-up 2) | ||
Number withdrawing from the trial | Recruitment logs | |
Study CONSORT diagram (randomisation, follow-up 1 and 2) | ||
2. Acceptability of CBT for those awaiting knee surgery for OA-related pain | Number of participants receiving the intervention | Treatment records |
Study CONSORT diagram (randomisation - received allocated intervention) | ||
Number of sessions completed | Treatment records | |
Number of participants who did not receive allocated treatment (that is, did not start treatment and discontinued treatment) | Treatment records | |
Study CONSORT diagram (randomisation - did not receive allocated intervention; follow-up - discontinued intervention) | ||
Participant views of treatment | Participant feedback interviews. | |
3a. Appropriateness of inclusion/exclusion criteria | Scores and rates of mood problems at screening | Screening questionnaires |
Study CONSORT diagram - number not meeting study inclusion criteria | ||
Participants’ medical notes | ||
3b. Acceptability of baseline and outcome measures | Rates of completion of questionnaires | Study CONSORT diagram – Follow-up (number of questionnaires returned and number lost to follow-up at 4 and 6 months after randomisation) |
Amount of missing items from questionnaires and whether this data was obtained with telephone follow-up | Outcome questionnaires | |
Specific items consistently missed from questionnaires | Outcome questionnaires | |
Ease of answering outcome questionnaires | Participant feedback interviews | |
3c. Audio recording of sessions | Number of participants consenting to sessions being audio recorded | Consent forms |
Number of participants consenting to be randomised | Study CONSORT diagram (randomisation) | |
3d. Randomisation protocol from participants’ perspectives | Participants’ views of the randomisation protocol | Participant feedback interviews |
4. Sample-size needed for a fully powered Phase III randomised controlled trial (RCT) | Power and sample size calculations based on descriptive statistics | Quantitative data: baseline and outcome measures |
5. The content of ‘treatment as usual’ (TAU), in order to describe this for this and future studies | TAU for SFH and NUH | Participant feedback interviews |
Data from the service use questionnaire (SUQ) | ||
6. The content of the intervention to inform the development of a treatment manual by time-sampling the content of therapy | Time-sampling (minute by minute coding of content) | Treatment audio recordings |
Saliency of analysis of intervention transcripts | Treatment audio recordings | |
Participant feedback interview transcripts | ||
7. The feasibility and acceptability of patient-partner led interviews, and patient-partner participation in interview data analysis | Number of participants consenting to be interviewed by a patient-partner | Study monitoring database |
Perceived challenges of conducting interviews | Patient-partner research diaries | |
Views on the effectiveness of this participatory research model | In-depth interviews with patient partners | |
Quality and consistency of interview data | Interview transcripts | |
8. The feasibility of collecting data for an economic evaluation using a service-use questionnaire and understanding the main cost drivers | Rates of completion | Service-use questionnaire |
Participant views of questionnaire items | Participant feedback interviews | |
9. Feasibility of conducting the interventions within existing patient pathways, that is, before TKA | Number of participants who do not complete treatment before their surgery date | Treatment attendance records |
Study CONSORT diagram |