Table 2 Assessment of the primary aim of the feasibility of the MAB study
Feasibility outcome | Mode of measurement | Quantitative/qualitative | Measurement of success | Analysis |
|---|---|---|---|---|
Recruitment rate | Clinical report form | Quantitative | Meeting our recruitment target of 45 participants | Narrative numerical reporting |
Specific obstacles to recruitment | a) Recruitment log b) Qualitative interviews with health professionals | Quantitative and qualitative | a) Complete record of recruitment with reasons for not meeting inclusion criteria or individuals’ reasons for refusal b) Identification of the obstacles to recruitment from health professionals | a) Narrative numerical reporting of recruitment with reasons b) Narrative description of the overarching obstacles identified by health professionals |
Adherence to the study therapy schedule | a) Clinical report form b) Participants’ diaries | Quantitative | a) Completion of clinical report form b) Completion of diaries and completion of sections with diaries | a) Narrative numerical reporting of completed CRF as participants progressed through trial b) Percentage completion of diaries and completion of items within individual diary sheets (3 per week) |
Acceptability of regular subcutaneous injections | a) Patient diaries b) Qualitative study | Qualitative | Identification of factors associated with acceptability or not of injection regimes | a) Narrative thematic and numerical report of acceptability b) Formal qualitative analysis from participants and health professional qualitative interviews |
Adverse events from mistletoe and placebo subcutaneous injections | a) Clinical report form b) (Serious) adverse events report forms | Quantitative | No serious adverse events reported No unexpected or unusual adverse events with mistletoe therapy | a) Narrative numerical reporting b) Numerical and descriptive categories of adverse events and serious adverse events |
Completion of outcome measures | Participants’ questionnaires | Quantitative | Completion of patient questionnaire and completion of questions within questionnaire | Narrative numerical reporting (%) completion of questionnaires plus % of questions completed within them |
Attrition rate with reasons if possible | Clinical report form/withdrawal form | Quantitative and qualitative | Reporting of withdrawals and dropouts with reasons | Narrative numerical reporting of withdrawals/dropouts with reasons |
Assessment of blinding of patients | a) Questions in final questionnaire b) Qualitative interviews and possibly diaries | Quantitative and qualitative | Definitive opinion of the participants with reasons | a) Narrative numerical reporting by participants of whether they thought they were receiving mistletoe/placebo or did not know plus reasons b) Narrative reporting of additional reasons for identifying allocation of treatment |
Assessment of therapy-related symptoms and health-related quality of life in the sample population | a) Participants’ diaries b) Qualitative interviews | Qualitative | Identification of therapy-related symptoms and general quality-of-life descriptions | a) Narrative thematic and numerical report of symptoms and descriptions of quality of life b) Formal qualitative analysis from participants |