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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