1. Methods reported in protocol but not used in this review.
| Issue | Method |
| Measures of treatment effect |
Continuous data Where standardised assessment tools generate a score as the outcome measure, we plan to compare the means of these scores and calculate a mean difference for inclusion in meta‐analysis, from data available from trial authors or calculated using methods outlined in Chapters 7 and 9 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Where studies do not use sufficiently similar instruments to measure an outcome, but the construct measured is similar, we plan to conduct meta‐analysis using standardised mean difference. |
| Unit of analysis issues | We will assess all included trials to determine the unit of randomisation and whether or not this unit of randomisation was consistent with the unit of analysis. Where cross‐over trials are used, we will extract mean and standard error of paired t‐tests and assess the clinical (pharmacodynamic) suitability of 'wash‐out' period and risk of spillover of drug effect for those who received drug treatment first. |
| Subgroup analysis | Subgroup analysis will be undertaken if clinically different intervention are identified or there are clinically relevant differences between subject groups: • age of participants (adult vs paediatric, preschool vs school age) • diagnostic classification • medication dose |
| Sensitivity analysis | Sensitivity analysis will be conducted to assess the impact of study quality on the results of meta‐analyses. For example, we will test to see if studies with high rates of loss to follow‐up or inadequate blinding are more likely to show positive outcomes. |