Assessment and Evaluation Flashcards

In a clinical trial, which document specifies exactly how and when each outcome assessment must be performed?

Answer: Study protocol

The protocol defines the schedule of assessments, procedures, and endpoints for the study.

Why are outcome assessors often blinded to participants' treatment assignment?

Answer: To reduce detection (ascertainment) bias

Blinding assessors prevents knowledge of treatment from influencing how outcomes are measured or judged.

A research assistant is unsure how to score an ambiguous item on a rating scale. What is the most appropriate action?

Answer: Follow the scoring manual and consult the PI or study coordinator, documenting the decision

Standardized scoring rules and documented consultation keep assessments consistent and auditable.

What is the main purpose of rater training and certification before a study begins?

Answer: To ensure assessments are administered and scored consistently across raters

Training and certification standardize administration and scoring, improving inter-rater reliability.

A participant completes a patient-reported outcome (PRO) questionnaire. Who should answer the questions?

Answer: The participant, without coaching or interpretation by staff

PROs capture the patient's own perspective, so the participant should answer without staff influence.

An evaluation designed to determine whether a program achieved its intended outcomes after completion is called what?

Answer: Summative evaluation

Summative evaluation judges a program's overall effectiveness at or after its conclusion.

A process evaluation of a smoking-cessation program would most likely examine which of the following?

Answer: Whether sessions were delivered as planned and how many participants attended

Process evaluation focuses on implementation fidelity, reach, and delivery rather than final outcomes.