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Table 1 Trial objectives, outcome measures and sources of data. For each trial objective, the outcome measure to be reported and the sources of the data are described. Trial source data include screening and recruitment logs, CONSORT diagram, and case report forms at the different time points (baseline, 4 months follow-up (1) and 6 months follow-up (2))

From: Home-administered pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): study protocol for a randomised controlled trial

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