Table 6 Summary of main findings for methodological issues identified by the ADePT Framework
Methodological issues | Findings | Evidence |
|---|---|---|
1. Did the feasibility/pilot study allow a sample size calculation for the main trial? | Although dependent on a small sample, sample size calculations were calculated | For example, assuming an average difference of 0.8 medications between intervention and control patients after 8Â months, an estimated 172 patients from 26 clusters should be recruited |
2. What factors influenced eligibility and what proportion of those approached were eligible? | Eligibility for clusters difficult to determine due to large number of non-responses. For patients, the most common reason for ineligibility at electronic searching stage was not being on ten or more medications and/ or being over 18 years. Other reasons included frailty, terminal illness or death | 282 of 289 practices were deemed eligible 677 of 80,604 (83,364 − 2760) patients were deemed eligible |
3. Was recruitment successful? | Targets for practice recruitment were met. Targets for patient recruitment were not | 15 out of a target of 16 practices recruited (94%), but recruitment took longer than anticipated 121 out of a target of 320 patients recruited within 1Â month (38%) |
4. Did eligible participants consent? | Low conversion to consent particularly for practices | 5.3% (15 out of potential 282 practices) consented 19.3% (131 out of potential 677 participants) consented (121 = 17.9% were eligible to participate) |
5. Were participants successfully randomised and did randomisation yield equality in groups? | Randomisation was successful with broadly similar practices and patients | |
6. Were blinding procedures adequate? | Yes for randomisation Not possible for data collection | Blinding with randomisation worked well |
7. Did participants adhere to the intervention? | Good adherence to implementation and documentation of the MyComrade Intervention | 88.3% (n = 52) fully completed checklist |
8. Was the intervention acceptable to the participants? | Acceptable for practices with some minor recommendations to change such as incentivisation. Patients were also positive but would like structured/formalised feedback on their medication review | Qualitative data showed that practices recognised the clinical importance of the intervention but raised concerns regarding long-term sustainability. Patients were positive but were concerned with the lack of communication on the medication review |
9. Was it possible to calculate intervention costs and duration? | Yes | See Appendix 5 |
10. Were outcome assessments completed? | Good completion rates of outcome assessments | Practice based: 88% and 8% of medication review checklists were fully and partially completed respectively Patient outcomes: 81 and 85% of patient questionnaires were returned at 4 and 8Â months respectively |
11. Were outcomes measured those that were the most appropriate outcomes? | Yes | Outcomes were consistent with the internationally agreed COSmm (Smith, 2018). Inclusion of additional outcomes from the COSmm could be considered in a full trial |
12. Was retention to the study good? | Yes | Practice retention was 100% Patient retention 81% (n = 98) at 4 months, 85% (n = 103) at 8 months |
13. Were the logistics of running a multicentre trial assessed? | Yes | Contracts with partner institutions and practices were identified as being resource intensive especially for a definitive trial |