Table 2 Mixed methods planning considerations for pilot feasibility studies

I. Identify the feasibility domain(s) to examine with mixed methods

1. Identify the feasibility domains of primary concern

2. Focus the plan to mix methods on the feasibility domain(s) of most uncertainty or complexity and/or potential to generate new knowledge that will inform the future trial

3. For the domain(s) needing mixed methods, formulate mixed methods integration questions consistent with the reason for wanting to combine quantitative and qualitative information

II. Align quantitative and qualitative data sources for the feasibility domain(s) selected for mixing methods

1. Specify benchmarks and set progression criteria for determining feasibility for the selected domain(s)

2. Identify the most relevant participants for the selected feasibility domain(s)

3. Identify the quantitative and qualitative data sources most appropriate for addressing the study’s questions about feasibility and determining whether benchmarks are met

4. Develop a data sources table that indicates the planned participants, data sources, and benchmarks for the examined feasibility domain(s)

III. Determine the timing of the quantitative and qualitative data collection within the flow of the pilot feasibility study activities

1. Map the flow of the major activities in the pilot study

2. Identify the specific points in the diagram when the different quantitative and qualitative data sources will be gathered

3. Apply mixed methods thinking while planning the timing of data collection by considering how the different sources of data can relate to each other

4. Consider how the data collection activities for the data sources relate to the intervention development and pilot study process such as using an iterative approach to piloting and being mindful not to introduce confounding influences that might interfere with the intervention implementation

IV. Plan integrative analyses using joint displays to understand feasibility

1. Plan to develop joint displays about the feasibility domain(s) selected for mixing and the reasons/questions that called for mixing methods

2. Develop a comparison joint display for the reason of triangulation and to corroborate whether a study is feasible for the selected domains

3. Develop a synthesis joint display for the reason of completeness and to form a comprehensive understanding of the complexity of selected feasibility domain(s)

4. Develop an interconnection joint display for the reason of explanation to uncover and explain differential patterns within selected feasibility domain(s) and within different contexts

V. Prepare to draw meta-inferences and implications about feasibility from the integrated data

1. Interpret the quantitative, qualitative, and mixed methods results to draw conclusions and meta-inferences about feasibility

2. Consider the implications for improving the intervention parameters

3. Consider the implications for optimizing the outcome measures

4. Consider the implications for modifying the trial methodology

5. Maintain an audit trail of insights, evidence, and specific implications