Designing a pilot or feasibility study is a critical step before launching a full-scale project. The key is to focus on how something can be done, not if it works.

Let's break down how to clearly define your feasibility objectives, ensuring they are distinct from effectiveness outcomes.

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Defining Feasibility Objectives (Not Effectiveness)

Feasibility objectives answer the question: "Can we do this?" They assess the practicality, acceptability, safety, and resources required for a larger study or intervention. They do not measure whether the intervention achieves its intended outcome (e.g., reduces symptoms, improves performance, changes behavior).

Think of it as testing the machinery and the logistics before you start mass production.

Step 1: Understand the Core Categories of Feasibility

Most feasibility objectives fall into one or more of these categories:

• Acceptability: How well is the intervention/protocol received by participants, deliverers, or other stakeholders? Do they find it suitable, desirable, or satisfactory?


• Demand/Recruitment/Retention: Can we recruit enough participants? How many agree to participate? How many drop out? Can they complete the intervention/study?


• Practicality/Implementation: Can the intervention/protocol be delivered as intended? What resources (time, staff, equipment) are needed? Are there logistical challenges? (Often includes Fidelity/Adherence: How well do participants stick to the intervention, or how well do deliverers stick to the protocol?)


• Safety/Adverse Events: Are there any unexpected harms or negative consequences associated with the intervention or study procedures?


• Resource/Cost: What are the actual costs and resources (human, material) required to deliver the intervention and conduct the study?


• Data Collection/Measurement: Can we effectively collect the required data using the chosen methods and instruments? Are the outcome measures appropriate, complete, and reliable in this context?


• Progression Criteria (Go/No-Go): What are the pre-defined thresholds or criteria that, if met, would indicate readiness to proceed to a larger study?

Step 2: Formulate SMART Feasibility Objectives

Each objective should be:

• Specific: Clearly state what you want to achieve.


• Measurable: Define how you will quantify success or failure. This is crucial for feasibility objectives – often involving thresholds, percentages, or frequencies.


• Achievable: Be realistic about what you can accomplish in a pilot.


• Relevant: Directly address a feasibility concern.


• Time-bound: Specify when the objective will be assessed (usually by the end of the pilot).

Crucially, for feasibility objectives, you MUST define what success looks like with a measurable threshold.

Step 3: Brainstorm Your Specific Feasibility Concerns

Before writing objectives, list out all the things you are worried about or unsure of regarding your proposed intervention or study protocol.

Example Scenario: You want to test an 8-week online cognitive behavioral therapy (CBT) program for university students experiencing mild anxiety, delivered through a new bespoke platform, with weekly therapist check-ins. You plan to conduct a full randomized controlled trial (RCT) later.

Brainstormed Concerns (Feasibility-focused):

• Will students sign up for an online program?


• Will they stick with it for 8 weeks?


• Is the online platform easy to use?


• Do the therapists have enough time for check-ins?


• Are the anxiety questionnaires too long or difficult?


• Will anyone get worse or report adverse events?


• What's the actual cost per participant?


• Will the tech support be overwhelmed?


• Can we collect enough data for a sample size calculation later?

Step 4: Draft Your Feasibility Objectives (with Thresholds!)

Now, translate your concerns into SMART objectives, explicitly stating the measurable criteria for success.

Using the Online CBT Program Scenario:

• Objective (Acceptability - Participant):


• To assess the acceptability of the 8-week online CBT program among university students, defined as ≥80% of participants reporting overall satisfaction (rated as "satisfied" or "very satisfied") with the program content and online platform experience (measured via post-program survey).


• (Not effectiveness: Doesn't ask if anxiety reduced, just if they liked the program.)


• Objective (Acceptability - Deliverer):


• To determine the acceptability of the weekly therapist check-in protocol, defined as therapists reporting the protocol to be "easy" or "very easy" to follow in ≥75% of post-session supervision logs.


• (Not effectiveness: Focuses on the protocol's ease for the therapist, not their therapeutic skill or participant outcome.)


• Objective (Recruitment/Retention):


• To determine the feasibility of recruitment, aiming to enroll 25 university students within a 6-week recruitment period.


• To assess participant retention, aiming for ≥70% of enrolled participants to complete at least 6 out of 8 program modules and the final assessment survey.


• (Not effectiveness: Focuses on getting people in and keeping them engaged with the process, not their anxiety levels.)


• Objective (Practicality/Fidelity - Participant):


• To evaluate participants' adherence to the online modules, defined as logging into and completing ≥75% of the core activities within each weekly module.


• (Not effectiveness: Measures engagement with the program delivery, not its impact.)


• Objective (Practicality/Fidelity - Deliverer):


• To assess the fidelity of therapist check-ins, aiming for ≥90% of check-ins to cover the five core topics as outlined in the protocol (assessed by supervision review of recorded sessions).


• (Not effectiveness: Checks if the protocol was followed, not if the check-in itself was therapeutically effective.)


• Objective (Safety/Adverse Events):


• To identify and track any program-related adverse events, aiming for <10% of participants reporting any mild or moderate adverse event related to the intervention.


• (Not effectiveness: Focuses purely on harm, not benefit.)


• Objective (Data Collection/Measurement):


• To determine the completeness of outcome measure data (e.g., GAD-7, PSS-10) at baseline, mid-program, and post-program, aiming for <15% missing data for any single scale at any time point.


• (Not effectiveness: Measures the ability to collect data, not the change in the data itself.)


• Objective (Progression Criteria - Go/No-Go):


• To establish clear criteria for progression to a full-scale RCT, whereby the full trial will proceed if all primary feasibility objectives (recruitment, retention, participant adherence, and safety) meet their predefined thresholds.


• (This is an overarching objective that summarizes your decision-making.)

Key Takeaways:

• Avoid "Does it work?" phrasing. Rephrase any effectiveness-oriented thoughts into questions about process or delivery.


• Quantify everything. If you can't put a number to it (e.g., ≥70%, <15%, 30 participants), it's not a strong feasibility objective.


• Define success clearly. What specifically will tell you that this aspect of your study is feasible?


• A pilot is for learning and refining. The results of these feasibility objectives will directly inform changes to your protocol before a larger study.

By following these steps, you'll develop a robust set of feasibility objectives that provide clear guidance for your pilot study and a solid foundation for future research.