Analysis of consultations
On average, consultations between service users and clinicians lasted an average of six and a half minutes (min = 2, max = 22), with the majority (66 %) lasting between 4 and 8 min. Table
2 shows the number of consultations (total n = 100) in which clinicians mentioned the 18 items, and the number of times they were either mentioned by service users throughout the course of the consultation, or recalled during summaries given to the researcher.
Table 2
Items required for explaining an EHR-linked research register, and how often they occur
1 | Having a health record | 77 | 0 |
2 | Having an EHR | 66 | 0 |
3 | Confidentiality of EHR | 28 | 0 |
4 | Benefits of research | 80 | 15 |
5 | Types of research | 54 | 12 |
6 | Personalised example of research | 48 | 4 |
7 | Researchers have been ‘approved’ | 52 | 6 |
8 | Researchers’ confidentiality | 37 | 12 |
9 | Researchers will identify you from EHR | 62 | 12 |
10 | Researchers may contact you in future | 94 | 44 |
11 | The register is voluntary | 77 | 23 |
12* | Future studies are voluntary | 62 | 17 |
13* | Service user can change their mind | 69 | 23 |
14 | Decision won’t affect care | 32 | 2 |
15* | Can stipulate, i.e., what/when/how contacted | 77 | 18 |
16 | Ask whether they wish to join the register | 84 | 0 |
17 | Questions and concerns | 67 | 0 |
18 | Who to contact for further information | 58 | 0 |
When explaining the EHR-linked register to service users, clinicians only mentioned EHRs in 66 % of consultations. Whilst most consultations contained reference to the fact that researchers might contact them in future to invite service users into research studies (94 %), clinicians less often mentioned the fact that this contact would be based upon researchers accessing their EHR (62 %). Service users’ comments reflect this during the consultation and/or their summary to the researcher; 44 % recalled that researchers would contact them in future, but only 12 % recalled that this would be based upon information in their EHR. Service users’ percentages should not be compared against clinicians’ percentages, since service users may have understood aspects without verbalising them to the researcher.
The most common example of service user misunderstanding related to confusing the process of signing up to the register with the process of signing up to studies. Clinicians only made this distinction in 62 % of the consultations. 15 % of service users voiced a misunderstanding to this effect, for example, asking questions such as “is the research starting now?”
Group comparisons identified differences between the service users who joined the register (n = 86), and those who refused to join (n = 14). Chi-Squared tests (two-sided) were used to test differences in service users’ responses based upon what clinicians had mentioned to them, as listed in Table
2. Significant differences in whether service users joined the register were found to relate to whether clinicians had explained three items; that future studies were voluntary (
χ2 = 4.38, df = 1, p = .036, C = .95), that the service user can change their mind (
χ2 = 5.71, df = 1, p = .017, C = .95), that the service user can stipulate aspects of the sign up process (
χ2 = 5.32, df = 1, p = .021, C = .95).
Confidentiality was another factor that related to service users’ willingness to sign up, although only 28 % of consultations included reference to the confidentiality of EHRs, and only 37 % described the confidentiality of researchers accessing EHRs. Most service users did not report feeling worried about confidentiality (in response to Likert question, Mean = 2.3, SD = 1.4), but those that did not join the register reported greater concerns (Mean = 3.9, SD = 1.3) than those who joined (Mean = 2, SD = 1.3). This difference was also significant (t = −5.25, df = 98, p = .000, C = .95).
According to the Likert scale responses for this study, most service users did not feel pressure to sign up to the register (Mean 1.48, SD = 0.88), they felt they had enough time to make a decision (Mean 4.29, SD = 1.05), and felt able to ask questions (Mean 4.64, SD = 0.72).
The revised training improved clinicians’ explanations. A comparison of the first 25 interviews and the remaining 75 showed that some parts of the item explanation checklist were more likely to be mentioned; (i) explaining EHRs (73 % Vs 36 %, χ2 = 11.34, df = 1, p = .001, C = .95), (ii) explaining the benefits of research (87 % Vs 60 %, χ2 = 8.33, df = 1, p = .006, C = .95), (iii) that researchers would contact service users in future (99 % Vs 80 %, χ2 = 11.58, df = 1, p = .003, C = .95), (iv) that such studies would be voluntary (67 % Vs 44 %, χ2 = 4.05, df = 1, p = .039, C = .95) and finally (v) service users were explicitly asked whether they wanted to join the register (95 % Vs 56 %, χ2 = 21.2, df = 1, p = .001, C = .95).