Appendix 2Differences between protocol and review
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| Details of difference | Comments |
|---|
| We planned to include evidence from crossover trials. We only included evidence from the first phase of crossover trials | A major concern of crossover trials is the carry-over effect. This occurs if an effect (e.g. pharmacological, physiological or psychological) of the treatment in the first phase is carried over to the second phase. As a consequence, on entry to the second phase the participants can differ systematically from their initial state despite a washout phase. For the same reason, crossover trials are not appropriate if the condition of interest is unstable.61 As both effects are very likely in severe mental illness, we used only data of the first phase of crossover studies |
| The planned outcomes list was reviewed and updated | As a consequence of the PPI session, outcome measures for the review were reviewed to also reflect outcomes important to patients |
| We planned to rely on evidence from the NMA. We decided not to rely on evidence from the NMA | The complete NMA was performed and it is available in Appendix 4. We have very little confidence in the results of the NMA because of (1) few data, (2) few studies in each comparison, (3) no differences between pairwise meta-analyses and NMA, and (4) not sufficiently connected networks. Therefore, we only used the results of the NMA to support planning future studies in this area |
| We carried out a different search from the protocol-specified search | As the Cochrane Schizophrenia Group maintains a good register that is regularly updated with a variety of databases and grey literature, we believed it was more appropriate to run the searches for all potential RCT TD references in their register. We also searched included and excluded studies of published Cochrane reviews |
