Table 2 Summary—assessment of the 12 methodological issues for feasibility studies
From: Self-administration of medication during hospitalization—a randomized pilot study
Methodological issues | Findings | Evidence |
|---|---|---|
1) Did the feasibility/pilot study allow a sample size calculation for the main trial? | Achieved from the error rate in the control group. | Error proportion 16.1% Sample size: observation of 1020 OEs per group |
2) What factors influenced eligibility and what proportion of those approached was eligible? | Ineligibility was mainly due to the following: patients not being capable of self-administration, not self-administering at home, and capable but not bringing own medications. | 153/441 patients assessed were eligible, see Fig. 2. |
3) Was recruitment successful? | Recruitment was satisfactory. | 60 patients were recruited within 3 months as planned. |
4) Did eligible participants consent? | Invited patients consented. | 10/70 patients declined |
5) Were participants successfully randomized and did randomization yield equality in groups? | Participants were successfully randomized with equality in groups. | No statistically significant differences between groups, e.g., gender (p = 1.0), age (p = 0.82), and length of stay (p = 0.51). See Table 3. |
6) Did participants adhere to the intervention? | Good adherence, but not all procedures worked in clinical practice (participants = nurses). | Nurses delivered less medication to patients in the intervention group than planned. Nurses did not remove the “self-administration status” from the eMAR at discharge as planned |
7) Was the intervention acceptable to the participants? | The intervention was well accepted by patients. | Highly satisfied—91.7% I; 66.7% C Prefer future SAM—94.4% I; 66.7% C |
8) Was it possible to calculate intervention costs and duration? | Further details in the calculation of costs and time measurements must be taken into account. Recruitment period was estimated to be 14 months. | Time used on other tasks than medication dispensing, administration, and SAM start must be measured. |
9) Were outcome assessments completed? | Main areas of interest were assessed. | Dispensing errors were observed in both groups with an error proportion of 3.4% in the intervention group and 16.1% in the control group. See Table 3. |
10) Were outcomes measured those that were the most appropriate outcomes? | Primary outcome was appropriate. It would be relevant to add secondary outcomes of SAM’s effects after discharge, e.g., perceptions regarding medication. | The proportion of dispensing errors in relation to OEs in total is appropriate as primary outcome for the safety of SAM. |
11) Was retention to the study good? | Retention was good. | Response rate follow-up—92.3 % I; 100 % C |
12) Did all components of the protocol work together? | The overall protocol worked as planned. Few adjustments were considered. | Adjustments were considered for exclusion criteria, recruitment procedure, intervention, and outcome methods (see numbers 1, 6, and 8 in this table) |