Table 3 Criteria for feasibility of the pilot randomised controlled trial
Explanation | Operationalisation and unit | |
|---|---|---|
Study design | ||
Recruitment rate | Relation between interested persons, eligible persons and study participants | n study participants / n interested persons [%]; n study participants / n eligible persons [%] |
Recruitment period | Time expenditure for recruitment of study participants | Time [weeks] |
Randomisation | Comparability of the randomised groups | Differences in primary outcomes between intervention- and control group at the beginning of the study [p-value] |
Blinding | Practicability and success rate of the blinding of the assessor | Proportion of the participants, who inadvertently reveal their group assignment to the assessor [%] |
Dropout rate | Drop-outs | n study participants who have not completed the study according to the protocol/ n study participants [%] |
Assessments | ||
Safety | Occurrence of adverse events/ complications | Absolute n of participants who had adverse events or showed aggravated symptoms related to the assessments |
Duration | Duration of the test battery including the questionnaires in minutes | Time [min] |
Acceptance | Participation in assessments and questionnaires | n of declined assessments or questionnaires/ n study participants [%] |
Interpretability/Completeness | Occurrence of floor and ceiling effects | ≥ 15% of study participants cannot perform an assessment; ≥ 15% of the study participants have the highest or lowest value of the scale |
Missing values in questionnaires or assessments | n missing values / n Items [%]. Critical if the median of missing items in a questionnaire or assessment is ≥10%. | |
Intervention | ||
Extent of the treatment | Frequency | sessions per week per study participant |
Duration | Median duration of one session [min] | |
Feasibility of the exercises | Refusal rate and estimation of the feasibility by the therapist | n exercises refused/ n exercises offered [%]; structured rating of the feasibility by the therapist |
Acceptance of the intervention | Subjective estimation of the study participants | Standardised personal rating by the participants |
Adverse events | Adverse events or complications, e.g. pain, loss of function, and consultation of a physician | Overall n of adverse events (mild/moderate/severe) which are not, unlikely, possibly, probably or definitely related to the intervention |
Costs | ||
Staff | Training: investigation of the outcomes | Total Duration [min]; cost [€] |
Training: execution of the intervention | Total Duration [min]; cost [€] | |
Screening and examination of the inclusion and exclusion criteria | Total Duration [min]; cost [€] | |
Investigation of the outcomes | Total Duration [min]; cost [€] | |
Execution of the intervention | Total Duration [min]; cost [€] | |
Additional contact to the study staff initiated by the participants (questions and wishes) | Total Duration [min]; cost [€] | |
Structure | Measurement instruments (material costs, license costs, software for the analysis) | Cost [€] |
Equipment for the exercises | Cost [€] | |
Ethics proposal | Cost [€] | |
Registration of the study | Cost [€] | |
Recruitment material (Flyer) | Cost [€] | |