Final FIT instrument summarising factors influencing the necessity and feasibility of randomisation, a control group and blinding
| Randomisation? | Control group? | Blinding of outcome assessors? | Blinding of patients and physicians? | Reference to reimbursement reports | Reference to the literature | |
|---|---|---|---|---|---|---|
| 1. When is randomisation, a control group or blinding necessary? | ||||||
| ▸ Confounding by indication | + | + | 17–20 | |||
| ▸ Natural decrease of symptoms over time | + | 35 | 22 | |||
| ▸ Subjective outcome measures | + | + | 17 20 23 | |||
| ▸ Differential behaviours across intervention groups | + | 17 20 23 | ||||
| ▸ Dramatic/immediate effects | − | − | 17 19 20 | |||
| 2A. When is randomisation, a control group or blinding hard to achieve? | ||||||
| ▸ Lack of equipoise, that is, consensus about the preferred treatment | − | Report I, III10 12 | 25 26 | |||
| ▸ Outcomes occur in the distant future | − | − | 17 18 22 27 | |||
| ▸ Small adaptation of an intervention that has already been proven effective and reimbursed | − | − | 25 | |||
| ▸ Extension of the indication area of a procedure that has already been proven effective and reimbursed | − | − | Report II11 | |||
| 2B. Which factors hinder the feasibility of randomisation, a control group or blinding? | ||||||
| ▸ Small patient population | − | Report IV, V13 14 | 17 25 | |||
| ▸ Poor prognosis/no alternative treatment | − | − | Report III12 | 29 | ||
| ▸ Intervention is common practice | − | Report I, III, V10 12 14 | 25 29 | |||
| ▸ Urgency of the intervention | − | − | 25 | |||
| ▸ Complexity of the intervention | − | − | 33 | 27 | ||
| ▸ Availability of good quality low level evidence of effectiveness | − | − | − | − | Report I, III, IV, V10 12–14 | |
A plus sign indicates that randomisation, a control group or blinding is necessary. A minus sign indicates that randomisation, a control group or blinding is unnecessary, is hard to achieve or is hindered.
FIT, Feasible Information Trajectory.