Internal validity (V1–V7)
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1 | Randomisation method presented. |
2a | Homogeneity of the population at entry of the study concerning diagnosis, confounding factors, prognostic factors. |
2b | Subgroup analysis done with respect to the mechanism for drooling if necessary. |
3 | Description of a method to control for “adherence to therapy”. |
4 | Description of a system for control of co-interventions (ENT surgery, behavioural therapy, and medication) at entry and during the study. |
5 | Standardised method of outcome measure fully described. |
6 | Repeated measurements during the observation period according to a fixed protocol. |
7 | Intention to treat analysis if applicable. |
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External validity (V8–V15)
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8 | Description of inclusion and exclusion criteria. |
9 | Accurate description of the planned therapy or interventions. |
10 | Check for co-intervention during the trial. |
11 | Outcome rates correctly listed in the text. |
12 | Description of relevant characteristics related to loss to follow up and adequate management of drop outs. |
13 | Presentation of the number of subjects “lost to follow up”. |
14 | Minimal follow up period of three months. |
15 | Control for side effects. |
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Data presentation (D1–D5)
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1 | Adequate sample size. |
2 | Presentation of the mean of the outcome measures. |
3 | Presentation of the standard deviation of the outcome measures. |
4 | Method of statistical analysis described in relation to the design used. |
5 | Appropriate statistical analysis done. |
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