DESIGN: Retrospective observational analysis.
SETTING: 56 acute stroke hospitals in eight countries.
PARTICIPANTS: 1074 trial physiotherapists, nurses, and other clinicians.
OUTCOME MEASURES: Number of babies born during trial recruitment per trial participant recruited.
RESULTS: With 198 site recruitment years and 2104 patients recruited during AVERT, 120 babies were born to trial staff. Births led to an estimated 10% loss in time to achieve recruitment. Parental leave was linked to six trial site closures. The number of participants needed to recruit per baby born was 17.5 (95% confidence interval 14.7 to 21.0); additional trial costs associated with each birth were estimated at 5736 Australian dollars on average.
CONCLUSION: The staff absences registered in AVERT owing to parental leave led to delayed trial recruitment and increased costs, and should be considered by trial investigators when planning research and estimating budgets. However, the celebration of new life became a highlight of the annual AVERT collaborators' meetings and helped maintain a cohesive collaborative group.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry no 12606000185561.
DISCLAIMER: Participation in a rehabilitation trial does not guarantee successful reproductive activity.
METHODOLOGY: The scoping review will be carried out in six stages: (1) identifying the research question, (2) identifying relevant studies through electronic databases (i.e., PubMed, Scopus, Cochrane Reviews, Google Scholar, EBSCOHOST, Science Direct) and also gray literature, and (3) selection of studies to be included based on inclusion criteria. Search and initial screening of studies to be included will be conducted by two independent reviewers. Discrepancies will then be solved through discussion with other reviewers; (4) charting and categorizing extracted data in a pretested data extraction form; (5) collating, summarizing, and reporting the results; and lastly, (6) conducting consultation with stakeholders and experts in diabetes.
DISCUSSION: This scoping review protocol is aimed to provide a framework enabling us to map and summarize the findings from existing studies involving meal replacement. It will help researchers to identify the research gap and provide recommendations for future meal replacement studies. The results from this scoping review will be useful to various stakeholders in healthcare. It is also part of a research project in which the information obtained will be utilized in a clinical trial of a developed meal replacement plan. Dissemination of knowledge will also be done through presentations at related scientific conferences.