Linda Tickle-Degnen; Nuts and Bolts of Conducting Feasibility Studies. Am J Occup Ther 2013;67(2):171–176. https://doi.org/10.5014/ajot.2013.006270
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Many factors can affect the successful implementation and validity of intervention studies. A primary purpose of feasibility and pilot studies is to assess the potential for successful implementation of the proposed main intervention studies and to reduce threats to the validity of these studies. This article describes a typology to guide the aims of feasibility and pilot studies designed to support the development of randomized controlled trials and provides an example of the studies underlying the development of one rehabilitation trial. The purpose of most feasibility and pilot studies should be to describe information and evidence related to the successful implementation and validity of a planned main trial. Null hypothesis significance testing is not appropriate for these studies unless the sample size is properly powered. The primary tests of the intervention effectiveness hypotheses should occur in the main study, not in the studies that are serving as feasibility or pilot studies.
a version of the main study that is run in miniature to test whether the components of the main study can all work together . . . [and resembles] the main study in many respects, including an assessment of the primary outcome. (Research Methods section, para. 6)
What are the expected
Numbers of eligible members of the targeted population?
Refusal rates for participation and for randomization?
Retention and follow-up rates as the participants move through the trial?
Adherence rates to study procedures, intervention attendance, and engagement?
How feasible and suitable are
Eligibility criteria? Are criteria clear and sufficient or too inclusive or restrictive?
Data collection assessments? Do participants understand the questions and other data collection methods? Do they respond with missing or unusable data?
Amount of data collection? Do the participants have enough time and capacity to complete data collection procedures? Does the overall data collection plan involve a reasonable amount of time, or does it create a burden for the participants?
Physical capacity to handle the number of participants? What is the square footage as related to the stages and tasks of the procedures?
Phone and communication technology capacity to stay in touch with and coordinate the participants? Is there Web and teleconferencing capability?
Time to conduct each stage and aspect of the protocol? What are the time frames, and how do they coordinate with other responsibilities? How long does it take to connect with a participant or to send out mailings?
Equipment in the correct place at the correct time? What equipment is needed, and is it available when needed?
Ability to deal with broken, lost, or stolen equipment and materials? Are there backup plans for obtaining needed equipment and materials?
Adequate software to capture and use data? What software is available for conducting the research?
Institutional, departmental, and clinical centers’ willingness, motivation, and capacity to carry through with project-related tasks and to support investigator time and effort? What administrative services are in place for research at this level?
Documented evidence indicating that these centers abide by their commitments? What are the challenges in fulfilling research support commitments?
Access to basic services, such as copying, libraries, institutional technology, data servers, and purchasing?
The investigators’ administrative capacity to manage the planned RCT?
Research investigator and staff capacities, expertise, and availability for the planned research activities?
Formats and structures of forms that document participant progress through the trial?
Accurate data entry into the computer? Are data lost, forgotten, or entered incorrectly? How are data files organized, named, and dated? Who is in charge of tracking the latest data entry and the quality of entry?
Matching of data to participants from different sources (e.g., participant screen data, consent and entry into the RCT, adherence, and responses on outcome measures)?
Management of the ethics of the research? To what extent do staff comply with the approved human participants protocol? How effectively are adverse events during implementation identified, documented, and reported? What happens if a participant experiences a clinical emergency or if family abuse is identified during the trial?
What is the level of safety of the procedures in the intervention or interventions?
What is the level of safety and burdensomeness of the frequency, intensity, and duration of the intervention? Can these and other elements be standardized in a protocol without loss of a client-centered, individualized focus?
What are the reliability, validity, and trustworthiness of the assessments for the targeted population for this specific intervention? Do the assessments capture individual participants’ needs and measure their responsiveness to these needs?
What values constitute clinically meaningful differences on the primary outcome measures or assessment procedures?
What is the expected degree of change (i.e., responsiveness) of the participants?
What are the estimates of the intervention effect and the variance of that effect across the planned population?
What are the expected subgroup effects (i.e., specificity effects or moderator variables)?
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