Table 2.

Module A: Reporting Standards for Studies With an Experimental Manipulation or Intervention (in Addition to Material Presented in Table 1)

Paper section and topic	Description
Method
Experimental manipulations or interventions	Details of the interventions or experimental manipulations intended for each study condition, including control groups, and how and when manipulations or interventions were actually administered, specifically including:  Content of the interventions or specific experimental manipulations   Summary or paraphrasing of instructions, unless they are unusual or compose the experimental manipulation, in which case they may be presented verbatim  Method of intervention or manipulation delivery   Description of apparatus and materials used and their function in the experiment    Specialized equipment by model and supplier  Deliverer: who delivered the manipulations or interventions   Level of professional training   Level of training in specific interventions or manipulations   Number of deliverers and, in the case of interventions, the M, SD, and range of number of individuals/units treated by each  Setting: where the manipulations or interventions occurred  Exposure quantity and duration: how many sessions, episodes, or events were intended to be delivered, how long they were intended to last  Time span: how long it took to deliver the intervention or manipulation to each unit  Activities to increase compliance or adherence (e.g., incentives)  Use of language other than English and the translation method
Units of delivery and analysis	Unit of delivery: How participants were grouped during delivery  Description of the smallest unit that was analyzed (and in the case of experiments, that was randomly assigned to conditions) to assess manipulation or intervention effects (e.g., individuals, work groups, classes)  If the unit of analysis differed from the unit of delivery, description of the analytical method used to account for this (e.g., adjusting the standard error estimates by the design effect or using multilevel analysis)
Results
Participant flow	Total number of groups (if intervention was administered at the group level) and the number of participants assigned to each group:  Number of participants who did not complete the experiment or crossed over to other conditions, explain why  Number of participants used in primary analyses Flow of participants through each stage of the study (see Figure 1)
Treatment fidelity	Evidence on whether the treatment was delivered as intended
Baseline data	Baseline demographic and clinical characteristics of each group
Statistics and data analysis	Whether the analysis was by intent-to-treat, complier average causal effect, other or multiple ways
Adverse events and side effects	All important adverse events or side effects in each intervention group
Discussion	Discussion of results taking into account the mechanism by which the manipulation or intervention was intended to work (causal pathways) or alternative mechanisms If an intervention is involved, discussion of the success of and barriers to implementing the intervention, fidelity of implementation Generalizability (external validity) of the findings, taking into account:  The characteristics of the intervention  How, what outcomes were measured  Length of follow-up  Incentives  Compliance rates The “clinical or practical significance” of outcomes and the basis for these interpretations