Some of the information in this chapter is reported in Chew-Graham et al. (paper under review).
Quantitative results
Recruitment
The target sample size for the feasibility study was 20–30 participants, who were to be recruited over 5 months (February to June 2017) from four to six CPs (see Chapter 1, Progression criteria).
A total of 24 participants were recruited to the study over a period of 9 months (April to December 2017) and from across a total of eight CPs, indicating that recruitment was slower than anticipated. Five CPs commenced recruitment in April 2017; however, owing to the observed slow recruitment, the recruitment period was extended (by 4 months) and three additional CPs were recruited to the study (from August 2017). One general practice conducted a database search and mailed out study information packs to eligible patients (eligible and recruited participants were associated with a single recruiting CP). Figure 1 shows a breakdown of recruitment over the 9-month recruitment period.
FIGURE 1 Feasibility study: target and actual recruitment rates. Reproduced with permission from Chew-Graham et al.75 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the original figure. (Figure not reproduced here; see the original article.)
Overall, 1082 study information packs were distributed: 882 packs via pharmacy-based recruitment methods (opportunistic approach within the CP, via home-delivered prescriptions and via pharmacy system searches) and 200 packs via GP-based recruitment methods. From this, 71 pharmacy customers/patients returned a consent form to the study team to indicate their interest in the study (6.6%), of whom 28 were eligible to participate in the study following eligibility screening (39.4% of the 71 screened) and 24 (85.7%) decided to take part in the study. Reasons for ineligibility can be found in Table 1, with the most common reason being either non-depressed (34.9%) or currently experiencing an episode of major depression (34.9%). Table 2 details the distribution of study information packs, returned consent forms and resultant screened and recruited participants. Recruitment activity by pharmacy is shown in Table 3.
| Reason for ineligibility | Number of people ineligible, n (%) (N = 43) |
|---|---|
| Non-depressed (MINI score < 2) | 15 (34.9) |
| Major depressive episode (MINI score ≥ 5) | 15 (34.9) |
| Currently receiving any form of psychological therapy | 3 (7.0) |
| Does not have a CHEMIST LTC | 1 (2.3) |
| No longer interested when contacted for eligibility screening | 5 (11.6) |
| Uncontactable | 4 (9.3) |
| Recruitment method | Study information packs given out (n) | Returned consent forms, n (%)a | Recruited, n (%)a |
|---|---|---|---|
| In the CP | 168 | 32 (19.0) | 14 (8.3) |
| Via home-delivered prescriptions | 414 | 23 (5.6) | 6 (1.4) |
| CP system searches (one conducted) | 300 | 9 (3.0) | 2 (0.7) |
| General practice searches (one conducted) | 200 | 7 (3.5) | 2 (1.0) |
| Total | 1082 | 71 (6.6) | 24 (2.3) |
| Pharmacy | Study information packs given out (n) | Returned consent forms, n (%) | Participants recruited, n (%) | |||
|---|---|---|---|---|---|---|
| Pharmacy | GP | Pharmacya | GPa | Pharmacya | GPa | |
| 1 | 347 | 0 | 11 (3.2) | – | 2 (0.6) | – |
| 2 | 17 | 200 | 4 (23.5) | 7 (3.5) | 0 (0.0) | 2 (1.0) |
| 3 | 28 | 0 | 12 (42.9) | – | 5 (17.9) | – |
| 4 | 147 | 0 | 15 (10.2) | – | 7 (4.8) | – |
| 5 | 39 | 0 | 4 (10.3) | – | 2 (5.1) | – |
| 6 | 34 | 0 | 1 (2.9) | – | 0 (0.0) | – |
| 7 | 129 | 0 | 9 (7.0) | – | 5 (3.9) | – |
| 8 | 141 | 0 | 8 (5.7) | – | 1 (0.7) | – |
| Total | 882 | 200 | 64 (7.3) | 7 (3.5) | 22 (2.5) [34.4]b | 2 (0.2) [28.6]b |
The active recruitment period across CPs varied from 2.7 months to 7.2 months, with an average period of 5.5 months; however, it should be noted that the three pharmacies that were recruited part-way through the 9-month recruitment period were open to recruitment for a maximum period of 5 months. This gives an average recruitment rate of 0.55 participants per pharmacy per month. Rates of recruitment varied across the pharmacies, with the proportion of those participants screened who were subsequently recruited to the study ranging from 0 to 0.55 and with, on average, 30.3% of those screened participating in the study; Figure 2 details the screening and recruitment for each pharmacy. The flow of participants through the study is shown in the Consolidated Standards of Reporting Trials (CONSORT) flow diagram in Figure 3.
FIGURE 2 Feasibility study: overall screening and recruitment per pharmacy. Reproduced with permission from Chew-Graham et al.75 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the original figure. (Figure not reproduced here; see the original article.)
FIGURE 3 Feasibility study: CONSORT flow diagram. a, Multiple reasons for exclusion may be given. Reproduced with permission from Chew-Graham et al.75 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the original figure. (Figure not reproduced here; see the original article.)
Participant characteristics
Baseline data for the 24 recruited participants are detailed fully in Table 4. There were no missing data with respect to participant characteristics. The average age of the participants was 66.8 years, ranging from 51.3 years to 83.6 years. One-quarter of the participants were male and most (87.5%) responded positively to Whooley question 1 (‘During the last month, have you often been bothered by feeling down, depressed or hopeless?’) and to Whooley question 2 (‘During the past month, have you often been bothered by having little interest or pleasure in doing things?’) (95.8%). There was a wide variety of health problems, with the most common being high blood pressure (n = 16). All of the participants classified themselves as being of white ethnicity; it is noted that all of the recruiting CPs were located in the north-east of England, which has a largely white population. The majority of participants (n = 14) did not continue with education after the minimum school leaving age; however, six participants indicated that they had a degree or equivalent-level qualifications. See Table 6 for the baseline standardised measures alongside those at the 4-month follow-up.
| Baseline characteristic | Participants (N = 24) |
|---|---|
| Age (years) | |
| Mean (SD) | 66.8 (9.8) |
| Median (minimum, maximum) | 65.9 (51.3, 83.6) |
| Gender, n (%) | |
| Male | 6 (25.0) |
| Female | 18 (75.0) |
| During the last month, have you often been bothered by feeling down, depressed or hopeless, n (%) | |
| Yes | 21 (87.5) |
| No | 3 (12.5) |
| During the past month, have you often been bothered by having little interest or pleasure in doing things? n (%) | |
| Yes | 23 (95.8) |
| No | 1 (4.2) |
| On average, do you drink 3 or more units of alcohol each day? n (%) | |
| Yes | 1 (4.2) |
| No | 23 (95.8) |
| Do not know | 0 (0.0) |
| Smoking status, n (%) | |
| Non-smoker | 12 (50.0) |
| Current smoker | 4 (16.7) |
| Ex-smoker | 8 (33.3) |
| Health problems,a n (%) | |
| Diabetes mellitus | 7 (29.2) |
| Osteoporosis | 2 (8.3) |
| High blood pressure | 16 (66.7) |
| Rheumatoid arthritis | 3 (12.5) |
| Osteoarthritis | 9 (37.5) |
| Stroke | 5 (20.8) |
| Cancer | 2 (8.3) |
| Respiratory conditions | 7 (29.2) |
| Eye conditions | 3 (12.5) |
| Heart disease | 8 (33.3) |
| Other | 14 (58.3) |
| Did your education continue after the minimum school leaving age? n (%) | |
| Yes | 10 (41.7) |
| No | 14 (58.3) |
| Do you have a degree or equivalent professional qualification? n (%) | |
| Yes | 6 (25.0) |
| No | 18 (75.0) |
| Ethnicity, n (%) | |
| White | 24 (100.0) |
| Asian or Asian British | 0 (0.0) |
| Black or black British | 0 (0.0) |
| Other ethnic group | 0 (0.0) |
| Number of children, n (%) | |
| 0 | 4 (16.7) |
| 1 | 7 (29.2) |
| 2 | 8 (33.3) |
| 3 | 5 (20.8) |
| ≥ 4 | 0 (0.0) |
| Marital status, n (%) | |
| Single | 1 (4.2) |
| Divorced/separated | 1 (4.2) |
| Widowed | 5 (20.8) |
| Cohabiting | 2 (8.3) |
| Civil partnership | 3 (12.5) |
| Married | 12 (50.0) |
Intervention delivery
All of the 24 participants were offered the ESI, of whom 17 (70.8%) commenced the ESI. Engagement with the ESI sessions is detailed in Table 5. In total, 10 out of the 17 participants completed all six sessions of the ESI (58.8%), with all those participants who commenced the ESI receiving at least three of the ESI sessions. A total of 91 ESI sessions were conducted, of a possible 102, giving an average completion of 86.1% for those who commenced the ESI.
| Total number of ESI sessions completed | Number of participants |
|---|---|
| 6 | 10 |
| 5 | 4 |
| 4 | 2 |
| 3 | 1 |
| 2 | 0 |
| 1 | 0 |
| Did not commence ESI | 7 |
A total of 17 ESI facilitators completed the ESI training as part of the feasibility study, and 13 were available to deliver the ESI during the intervention period, of whom nine supported at least one participant through the ESI. The average number of participants supported by an ESI facilitator was 1.9 participants (ranging from one to four participants).
All seven participants who did not start the ESI sessions withdrew from the ESI before the sessions commenced. Reasons (where known) for not commencing the ESI sessions included no longer feeling that the intervention was relevant, ill health, feeling better, the family feeling that the study was not suitable for the participant, and being unable to contact the participant to arrange ESI sessions.
Follow-up and withdrawal
Seven participants (29.2%) withdrew from the ESI before commencing the sessions (see Intervention delivery); of these, one participant withdrew fully from the study.
Twenty of the remaining 23 participants completed and returned a 4-month follow-up questionnaire, giving a return rate of 87.0%; this included five participants who did not commence the ESI. Overall, the retention rate for the feasibility study at 4 months was 83.3% (20 out of the 24 participants).
Standardised measures
A range of standardised measures were collected during the feasibility study (see Chapter 2) to assess for completeness and suitability for use in the pilot RCT. These measures included the PHQ-9, GAD-7 and Patient Health Questionnaire-15 (PHQ-15).63,65,66 Scores for these measures at baseline and at the4-month follow-up can be found in Table 6.
| Measure | Overall (N = 24) |
|---|---|
| PHQ-9 depression (range 0–27)a | |
| Baseline (N = 24) | |
| Mean (SD) | 13.5 (5.8) |
| Median (minimum, maximum) | 13 (2, 24) |
| No depression (0–4), n (%) | 1 (4.2) |
| Mild depression (5–9), n (%) | 4 (16.7) |
| Moderate depression (10–14), n (%) | 12 (50.0) |
| Moderately severe depression (15–19), n (%) | 2 (8.3) |
| Severe depression (20–27), n (%) | 5 (20.8) |
| 4-month follow-up (N = 19) | |
| Mean (SD) | 9.9 (6.1) |
| Median (minimum, maximum) | 9 (3, 20) |
| No depression (0–4), n (%) | 5 (26.3) |
| Mild depression (5–9), n (%) | 7 (36.8) |
| Moderate depression (10–14), n (%) | 1 (5.3) |
| Moderately severe depression (15–19), n (%) | 5 (26.3) |
| Severe depression (20–27), n (%) | 1 (5.3) |
| GAD-7 anxiety (range 0–21)a | |
| Baseline (N = 24) | |
| Mean (SD) | 10.3 (5.0) |
| Median (minimum, maximum) | 10 (1, 21) |
| No anxiety (0–5), n (%) | 2 (8.3) |
| Mild anxiety (5–10), n (%) | 9 (37.5) |
| Moderate anxiety (10–15), n (%) | 8 (33.3) |
| Severe anxiety (15–21), n (%) | 5 (20.8) |
| 4-month follow-up (N = 19) | |
| Mean (SD) | 6.5 (4.6) |
| Median (minimum, maximum) | 6 (0, 16) |
| No anxiety (0–5), n (%) | 7 (36.8) |
| Mild anxiety (5–10), n (%) | 8 (42.1) |
| Moderate anxiety (10–15), n (%) | 2 (10.5) |
| Severe anxiety (15–21), n (%) | 2 (10.5) |
| PHQ-15 somatic (range 0–30)a | |
| Baseline (N = 24) | |
| Mean (SD) | 14.8 (4.7) |
| Median (minimum, maximum) | 15 (4, 25) |
| Minimal (0–5), n (%) | 1 (4.2) |
| Low (5–10), n (%) | 2 (8.3) |
| Medium (10–15), n (%) | 8 (33.3) |
| High (15–30), n (%) | 13 (54.2) |
| 4-month follow-up (N = 20) | |
| Mean (SD) | 13.2 (4.5) |
| Median (minimum, maximum) | 14 (5, 23) |
| Minimal (0–5), n (%) | 0 (0.0) |
| Low (5–10), n (%) | 4 (20.0) |
| Medium (10–15), n (%) | 7 (35.0) |
| High (15–30), n (%) | 9 (45.0) |
Overall, the level of completion for these standardised measures in the feasibility study was excellent: 100% at baseline for all measures and between 95% and 100% at the 4-month follow-up (of those who returned the questionnaires). Although there is only a small sample of data, and for this reason no formal comparisons can be made, it does appear that the results change slightly between baseline and 4 months.
Although the intention had been for participants to complete the BADS during ESI sessions (see Chapter 2, Outcome measures), this measure was not administered during the feasibility study. In addition, additional information (relating to depression history) was also not obtained during the feasibility study. These data will be collected in the pilot RCT described in Chapters 6–10.
Competency and intervention fidelity
Of the 17 ESI facilitators who completed the ESI training, nine passed the competency assessment on the first attempt and, following additional telephone-based support, six passed on the second attempt and one on the third attempt (one ESI facilitator left the pharmacy before attempting the competency assessment). All ESI facilitators who went on to support participants through the ESI received session-by-session clinical supervision.
Although the intention was to audio-record ESI sessions (with participant consent) to assess fidelity to the ESI, the decision was made not to record these during the feasibility study. CHEMIST represented a new challenge for the recruiting CPs (the majority of which had no prior experience of research). Many of the ESI facilitators had limited experience of mental health, were new to working with the participant group (people with subthreshold depression and LTCs) and were engaging with new experiential training methods. The study team felt, on reflection, that asking ESI facilitators to record ESI sessions in addition to delivering the ESI within the setting of a CP would be an unfair burden on this group, and may risk ESI facilitator dropout. This decision was made in consultation with the wider study team, the CHEMIST stakeholders and the funder.
Although recordings of ESI sessions were not obtained, close monitoring of ESI delivery and adherence to the ESI manual took place (as originally planned). This was achieved through session-by-session clinical supervision at which the content and delivery of each ESI session was discussed, allowing the clinical supervisor to offer support and advice (to include adherence to the ESI manual) following each delivered ESI session. ESI facilitators were also required to complete a participant treatment log for each delivered ESI session, which was reviewed during each clinical supervision session.
Fidelity to the ESI would be examined in the pilot RCT, by which point it was anticipated that study processes would be more embedded in CPs and ESI facilitators would have increased confidence in these new training and assessment procedures. ESI facilitators would be advised of the need to audio-record sessions during the pilot RCT ESI training workshop.
Serious adverse events
There were no SAEs reported in the feasibility study.
Clinical results: summary
The feasibility study suggests that it is possible to recruit to the study; however, recruitment was much slower than anticipated, which highlights the novelty of conducting a mental health research study within a busy CP setting. The completeness of the outcome measures and the return rate of the questionnaires indicate that this patient population were willing to complete the questionnaires and were keen to stay active participants in the study. Equally, the high completeness (86.1%) of the ESI (for those participants who commenced the ESI) suggests that participants find the intervention acceptable and are willing to participate in the ESI sessions (see Chapter 4). This also suggests that CP staff can be successfully trained to deliver the ESI in a CP setting.
With respect to the predetermined criteria for progressing from the feasibility study to the pilot RCT (see Chapter 1) as follows:
- Recruit five participants at each of four to six CPs by month 6 – 24 participants were recruited across eight CPs over a 9-month recruitment period (the last participant was recruited in month 12).
- For 80% of participants to receive two or more ESI sessions within the 4-month post-recruitment period – 17 out of the 24 recruited participants (70.8%) received two or more ESI sessions (100% of those commencing the intervention) within the 4-month post-recruitment period. The remaining seven participants did not commence the ESI.
- Collect valid (intended) primary outcome measure on 80% of recruited participants at the 4-month post-recruitment follow-up – the retention rate was 83.3% at the 4-month post-recruitment follow-up, with 95% data completeness for the PHQ-9.
- A fidelity score of ‘acceptable’ (3) or above to be achieved in a least 90% of assessed audio-recorded ESI sessions – to be examined in the pilot RCT (see Competency and intervention delivery).
Interviews with participants and ESI facilitators conducted as part of the feasibility qualitative study will further explore the feasibility and acceptability of the study, ESI training and delivery, and study procedures (see Chapter 4).
Following discussions with the TSC and the funder, progression to the external pilot RCT was recommended.
Health economic results
Health services resource use
Data completion
At baseline and at the 4-month follow-up, all participants responded to the bespoke resource use questionnaire. Moreover, there were no missing data for any of the resource use items at either time point. Four participants did not complete the 4-month follow-up and, therefore, had no resource use information available (note that this is also reflected in the overall questionnaire completion rate in the study). The analysis also explored if the participants who did not provide follow-up data had a higher level of resource use at baseline (i.e. any sign of non-random dropout), but found their resource use to be similar to the participants who provided follow-up data.
Frequency of health service use
Tables 7 and 8 show the frequency of use of each type of health service in the last 4 months, measured at baseline and at the 4-month follow-up. The aim was to evaluate if responses were within the expected range of health service use and not to draw statistical inference regarding the differences between baseline and follow-up.
| Primary care | Time point, mean (range) | |||
|---|---|---|---|---|
| Baseline | 4-month follow-up | |||
| Number of appointments for any reason | Number of appointments for low mood | Number of appointments for any reason | Number of appointments for low mood | |
| GP at the clinic | 3.08 (0–16) | 0.3 (0–3) | 3.3 (0–10) | 0.2 (0–4) |
| GP at home | 0.63 (0–6) | 0 (0–0) | 0.2 (0–2) | 0 (0–0) |
| GP on the telephone | 0.79 (0–5) | 0 (0–0) | 0.55 (0–3) | 0 (0–0) |
| Nurse at the clinic | 0.96 (0–4) | 0 (0–0) | 0.75 (0–4) | 0.05 (0–1) |
| Nurse at home | 0.67 (0–10) | 0 (0–0) | 0.3 (0–3) | 0 (0–0) |
| Nurse on the telephone | 0.25 (0–5) | 0 (0–0) | 0.1 (0–2) | 0 (0–0) |
| NHS Direct | 0.13 (0–2) | 0 (0–0) | 0.1 (0–2) | 0 (0–0) |
| NHS walk-in centre | 0.17 (0–2) | 0 (0–0) | 0.1 (0–2) | 0 (0–0) |
| Occupational health services | 1 (0–14) | 0 (0–0) | 0.1 (0–1) | 0 (0–0) |
| Social worker or community support worker | 0.17 (0–4) | 0 (0–0) | 0.25 (0–5) | 0 (0–0) |
| Drug and alcohol support worker | 0 (0–0) | 0 (0–0) | 0 (0–0) | 0 (0–0) |
| Type of service | Time point, mean (range) | |
|---|---|---|
| Baseline | 4-month follow-up | |
| Mental health services | ||
| Psychotherapist or counsellor | 0.5 (0–10) | 0.15 (0–3) |
| Clinical psychologist | 0 (0–0) | 0 (0–0) |
| Community mental health team or community psychiatric nurse | 0 (0–0) | 0 (0–0) |
| Consultant psychiatrist | 0 (0–0) | 0 (0–0) |
| Hospital-based services | ||
| Outpatient appointments | 1.7 (0–8) | 0.76 (0–3) |
| Accident and emergency | 0.15 (0–1) | 0.1 (0–2) |
| Urgent care centre or minor injuries unit | 0 (0–0) | 0.05 (0–1) |
| Admission with overnight stay | 0.25 (0–1) | 0.14 (0–1) |
| Admission without overnight stay | 0.1 (0–1) | 0 (0–0) |
At baseline and the 4-month follow-up, GP consultations were the most common category of resource use. The mean number of GP consultations at the clinic was 3.08 and 3.3 for baseline and the 4-month follow-up, respectively. Only a small proportion of visits were because of low mood. Resource use in other categories was low at both time points. The numerical values of the number of visits per participant was within plausible range for all resource use categories at both time points. In addition, the mean number of visits did not show any unexpected changes over time.
During the feasibility study it was noticed that participants had a number of appointments with the pharmacist that were not recorded by the resource use questionnaire.
Health-related quality of life
Health-related quality-of-life data were collected using the EQ-5D73 and SF-12v267 questionnaires at baseline and at the 4-month follow-up.
Data completion, frequency and pattern of EuroQol-5 Dimensions and Short Form-12 item responses
Data completion was 100% for all domains of EQ-5D and SF-12v2 at baseline and the 4-month follow-up (except for one non-response to item 2 in SF-12v2 at follow-up). This indicates that participants found it feasible to complete these questions. Moreover, responses were within the plausible range (i.e. 1–3 for EQ-5D and 1–5 for SF-12v2). The frequency and pattern of EQ-5D and SF-12v2 responses at both time points were also assessed. Based on the EQ-5D questionnaire, at baseline and the 4-month follow-up most respondents had some level of problem in at least one of the five domains; participants reported the lowest level of problems in the self-care domain. For the anxiety/depression domain, 3 out of 24 participants, 17 out of 24 and 4 out of 24 reported no problems, some problems and severe problems, respectively, at baseline (i.e. 87.5% of respondents reported experiencing symptoms of anxiety/depression) (Table 9). This is not surprising given that participants with subthreshold depression were recruited to the study. At the 4-month follow-up, there was little change in most domains except for anxiety/depression, with a slight decrease in the number of participants experiencing moderate anxiety/depression. However, the numbers are too small to draw any conclusions about the trend.
| EQ-5D domain | Time point | No problems | Some problems | Severe problems |
|---|---|---|---|---|
| Mobility | Baseline | 5 | 19 | 0 |
| 4-month follow-up | 5 | 15 | 0 | |
| Self-care | Baseline | 12 | 12 | 0 |
| 4-month follow-up | 13 | 7 | 0 | |
| Usual activities | Baseline | 3 | 17 | 4 |
| 4-month follow-up | 4 | 13 | 3 | |
| Pain/discomfort | Baseline | 0 | 11 | 13 |
| 4-month follow-up | 0 | 12 | 8 | |
| Anxiety/depression | Baseline | 3 | 17 | 4 |
| 4-month follow-up | 7 | 11 | 2 |
The SF-12v2 questionnaire produced similar responses to the EQ-5D questionnaire, with most respondents having some level of problem in at least one of the domains (Table 10). A large proportion of study participants reported having fair or poor general health (SF-1). Participants reported the highest level of problems in the physical health and vitality domains. For the mental health domain (SF-9 and SF-11), all except one participant reported at least some level of problem at baseline. This is consistent with the EQ-5D responses and in line with the study eligibility criteria. At the 4-month follow-up, there was little change in most domains, except small improvements in the mental health (SF-11) and vitality (SF-10) domains. However, the numbers are too small to draw any conclusions about the trend.
| Item | Time point | Level | ||||
|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | ||
| SF-1 | Baseline | 0 | 1 | 2 | 6 | 15 |
| Follow-up | 0 | 1 | 3 | 12 | 4 | |
| SF-2 | Baseline | 12 | 9 | 3 | 0 | 0 |
| Follow-up | 10 | 7 | 2 | 0 | 0 | |
| SF-3 | Baseline | 12 | 9 | 3 | 0 | 0 |
| Follow-up | 10 | 9 | 1 | 0 | 0 | |
| SF-4 | Baseline | 4 | 9 | 6 | 5 | 0 |
| Follow-up | 3 | 5 | 10 | 1 | 1 | |
| SF-5 | Baseline | 1 | 13 | 7 | 3 | 0 |
| Follow-up | 2 | 6 | 10 | 1 | 1 | |
| SF-6 | Baseline | 1 | 7 | 10 | 5 | 1 |
| Follow-up | 0 | 3 | 9 | 4 | 4 | |
| SF-7 | Baseline | 1 | 6 | 9 | 3 | 5 |
| Follow-up | 2 | 2 | 7 | 3 | 6 | |
| SF-8 | Baseline | 1 | 4 | 1 | 14 | 4 |
| Follow-up | 2 | 3 | 1 | 11 | 3 | |
| SF-9 | Baseline | 0 | 3 | 4 | 13 | 4 |
| Follow-up | 0 | 7 | 6 | 5 | 2 | |
| SF-10 | Baseline | 0 | 4 | 3 | 5 | 12 |
| Follow-up | 0 | 2 | 5 | 4 | 9 | |
| SF-11 | Baseline | 0 | 10 | 10 | 3 | 1 |
| Follow-up | 1 | 6 | 6 | 4 | 3 | |
| SF-12 | Baseline | 4 | 8 | 9 | 3 | 0 |
| Follow-up | 3 | 5 | 7 | 4 | 1 | |
Health economic results: summary
The economic analysis evaluated the overall response rates, the item completion rates and the range of values provided in response to the bespoke resource use questionnaire and quality-of-life (EQ-5D and SF-12v2) questionnaires. Both health service resource use and EQ-5D questionnaires had 100% completion rate among participants at baseline and at the 4-month follow-up. There were no missing items in either questionnaire. GP visits were the most common types of resource use items. Overall, the economic analysis suggested a high level of questionnaire completion rate, a low level of item missingness and no out of range responses.