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Table 3 Criteria for feasibility of the pilot randomised controlled trial

From: Effects of a movement control and tactile acuity training in patients with nonspecific chronic low back pain and control impairment – a randomised controlled pilot study

  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 [€]