Table 2 Social and behavioral feasibility study design criteria suggested by Orsmond and colleagues [55]

Objective 1: Recruitment capability and resulting sample characteristics

Main question: Can we recruit appropriate participants?

 1. How many potential eligible members of the targeted population are accessible in the local community?

 2. What are the recruitment rates?

  a. How many participants enter the study at a time?

  b. How long does it take to recruit enough participants into the study?

  c. What are the refusal rates for participation?

 3. How feasible and suitable are eligibility criteria?

  a. Are criteria clear and sufficient or too inclusive or restrictive?

 4. What are the obstacles to recruitment?

  a. Are colleagues and local organizations willing to assist with recruitment?

  b. What are the reasons for refusal or ineligibility?

 5. How relevant is the intervention to the intended population?

  a. Do study participants show evidence of need for the intervention?

 6. Are the characteristics of the study participants consistent with the range of expected characteristics as informed by the research literature?

Objective 2: Evaluation and refinement of data collection procedures and outcome measures

Main question: How appropriate are the data collection procedures and outcome measures for the intended population and purpose of the study?

 1. How feasible and suitable are the data collection procedures?

  a. Do participants understand the questions and other data collection procedures?

  b. Do they respond with missing or unusable data?

 2. How feasible and suitable is the amount of data collection?

  a. Do the participants have the capacity to complete the data collection procedures?

  b. Does the overall data collection plan involve a reasonable amount of time or does it create a burden for the participants?

 3. Do the measures appear to be performing in a consistent way with the intended population as compared to measurement information available in the research literature?

  a. Are internal consistency indicators of measures with the recruited sample congruent with expectations based on prior studies reported in the research literature?

  b. Do planned outcome measures appear to be sensitive to the effects of the intervention?

  c. Does a suitable outcome measure need to be developed?

Objective 3: Acceptability and suitability of intervention and study procedures

Main question: Are study procedures and intervention suitable for and acceptable to participants?

 1. What are the retention and follow-up rates as the participants move through the study and intervention?

 2. What are the adherence rates to study procedures, intervention attendance, and engagement?

  a. Does the intervention fit with the daily life activities of study participants?

  b. Do the participants have enough time and capacity to complete the intervention?

  c. Does the intervention involve a reasonable amount of time, or does it create a burden for the participants?

  d. To what extent is the intervention acceptable and appealing to participants?

  e. If appropriate, how many participants agree to be randomized to group?

 3. What is the level of safety of the procedures in the intervention?

  a. Are there any unexpected adverse events?

Objective 4: Resources and ability to manage and implement the study and intervention

Main question: Does the research team have the resources and ability to manage the study and intervention?

 1. Does the research team have the administrative capacity, expertise, skills, space, and time to conduct the study and intervention?

 2. Can we conduct the study procedures and intervention in an ethical manner?

  a. To what extent does staff comply with the approved human participants’ protocol?

  b. How effectively are adverse events during implementation identified, documented, and reported?

 3. Can the study and intervention be conducted within the designated budget?

 4. Is the technology and equipment sufficient to conduct the study and intervention, including collection, management, and analysis of data?

  a. Is equipment available when needed?

  b. What is involved in training personal and/or participants to use the equipment?

 5. Are we able to efficiently and effectively manage data entry and analysis?

Objective 5: Preliminary evaluation of participant responses to intervention

Main question: Does the intervention show promise of being successful with the intended population?

 1. Does examination of quantitative data suggest that the intervention is likely to be successful?

  a. Does examination of the data at the participant level suggest that changes in key outcome variables occurred?

  b. Are the changes of the outcome variable(s) in the expected direction?

  c. Do the estimates of effects suggest that the intervention has promise?

 2. Do participants or relevant others provide qualitative feedback that may be indicative of the likelihood that the intervention will be successful?

 3. If the quantitative and/or qualitative data suggest that the intervention is not promising:

  a. Are the data collection procedures and outcome measures appropriate for the population and study?

  b. Are the outcome measures and intervention theoretically aligned?

  c. Is there evidence that the intervention does not produce change in the desired outcomes?

  d. Is there evidence that the intervention was not implemented in the intended manner?

  e. Have too many adaptations been made in the intervention process to adequately assess the participants’ responses to the intervention?

 4. Are the findings congruent with the proposed theoretical model for the intervention?