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? |