Certified Lactation Specialist Study Startup & Feasibility 3 — Questions and Answers
Question 1: What is the PRIMARY purpose of conducting a feasibility study before launching a full-scale lactation intervention trial?
- To publish preliminary results that support grant funding applications
- To assess whether the full trial can be conducted successfully and efficiently (Correct answer)
- To train all future study staff on the final protocol
- To recruit the maximum number of participants as quickly as possible
Correct answer: To assess whether the full trial can be conducted successfully and efficiently
Feasibility studies test procedures, resources, and acceptability to determine if a larger definitive trial is viable before full investment.
Question 2: During the pilot phase of a new inpatient breastfeeding support program study, which metric is MOST important to track?
- Participant satisfaction with hospital food and amenities
- Enrollment rate relative to the eligibility screening rate (Correct answer)
- Number of IRB amendments submitted during the study
- Total staff overtime hours accumulated
Correct answer: Enrollment rate relative to the eligibility screening rate
The yield rate (enrolled vs. screened eligible) indicates whether sufficient participants can be recruited to power a full trial.
Question 3: A site assessment for a lactation study feasibility evaluation should include which of the following?
- Review of the site's social media following and online reputation
- Evaluation of staff expertise, infrastructure, and patient delivery volume (Correct answer)
- Assessment of competing hospitals' marketing budgets
- Review of only the national breastfeeding initiation statistics
Correct answer: Evaluation of staff expertise, infrastructure, and patient delivery volume
Site assessment evaluates whether a location has the qualified personnel, physical facilities, and patient volume to support the study.
Question 4: Which tool is commonly used to systematically assess the feasibility of implementing a new lactation program at a hospital site?
- CONSORT checklist
- SWOT analysis (Correct answer)
- PRISMA statement
- GRADE framework
Correct answer: SWOT analysis
SWOT analysis (Strengths, Weaknesses, Opportunities, Threats) is a standard strategic tool for evaluating feasibility across internal and external dimensions.
Question 5: In the context of a lactation study, 'resource mapping' during feasibility assessment refers to:
- Creating a geographic map of regional breastfeeding rates by zip code
- Identifying all available personnel, equipment, space, and funding needed for the study (Correct answer)
- Mapping the flow of patient data through the electronic health record system
- Documenting all published research resources on lactation interventions
Correct answer: Identifying all available personnel, equipment, space, and funding needed for the study
Resource mapping inventories all inputs—staff, space, equipment, funding—needed to execute the study before startup.
Question 6: A hospital delivers 400 babies per year; 60% initiate breastfeeding and are eligible for a study. The study requires 100 enrolled participants in 12 months, and 50% of eligible patients are expected to consent. Approximately what fraction of eligible patients must be screened?
- 25%
- 42%
- 83% (Correct answer)
- 100%
Correct answer: 83%
400 × 60% = 240 eligible/year; 100 needed ÷ 50% consent = 200 must be screened; 200/240 ≈ 83%.
Question 7: Which of the following best describes a 'pilot study' in the context of lactation program research?
- A large-scale RCT testing the final intervention for efficacy
- A small-scale preliminary study used to test procedures and refine the protocol before a larger trial (Correct answer)
- A retrospective chart review of historical breastfeeding outcomes
- A systematic review and meta-analysis of existing lactation interventions
Correct answer: A small-scale preliminary study used to test procedures and refine the protocol before a larger trial
A pilot study is a smaller-scale version of the planned study designed to test and refine methods, not to test clinical efficacy.
Certified Lactation Specialist Study Startup & Feasibility 3
What is the PRIMARY purpose of conducting a feasibility study before launching a full-scale lactation intervention trial?