The nature of the organization which was developing, funding or implementing the intervention was not a selection criterion: interventions from all kinds of organizations were included (including research led initiatives, community led initiatives, and research-community partnerships).
The included studies were analyzed and cross-checked independently by two authors to extract the following information: study design, objectives and discussion, participants and eligibility criteria, intervention used, variables and measurement, key outcomes, and conclusions.
In this paper, we describe where each of the Air It Out study components falls along the pragmatic explanatory continuum regarding participant eligibility criteria, intervention and comparison condition design, follow-up and outcomes, compliance and adherence assessments, and analysis.
Studies were selected based on predefined criteria: intervention with tea as the sole experimental variable, placebo-controlled design, and no missing data on FMD outcome or its variability.
Information defined a priori included sample sizes, baseline characteristics, inclusion criteria, intervention details, study duration and number of contacts.
Narrow controls designed to optimize the internal validity of a trial (that is, inclusion/exclusion criteria, intervention protocol) can compete with and compromise overall generalizability [ 41].
Study details (inclusion/exclusion criteria, intervention and comparison treatments and outcome measure details) were extracted and summarized (see Additional file 1: Appendix 2).
A standardised data extraction form was used to collect population characteristics, trial inclusion and exclusion criteria, intervention details, outcome data and overall conclusions from each trial.
Extracted study characteristics were: the country where the study was conducted, size and source of the study population, eligibility criteria, intervention modes, and primary outcome measures.
Abstracts were screened by two researchers [NG,VMD] using the following inclusion criteria: intervention studies addressing problems of incontinence (UI and or FI) experienced by people with dementia or cognitive impairments living at home and reported in English.
