The Functional Living Index – Emesis (FLIE) is a rigorously developed patient-reported outcome (PRO) instrument specifically designed for assessing the impact of chemotherapy-induced nausea and vomiting (CINV) on patients’ everyday activities. FLIE was developed to overcome limitations of traditional self-diary reports by offering a more structured and reproducible evaluation of how nausea and vomiting affect functional living across various daily life domains.
Originally, FLIE was designed to capture changes in patients’ quality of life during a three-day period following chemotherapy administration, focusing primarily on the acute phase of CINV. Given the complexity of nausea and vomiting that can extend beyond the acute window, modified versions of FLIE now include a five-day recall period. This expanded time frame ensures that both the acute and delayed phases of CINV are adequately monitored, providing clinicians and researchers with more comprehensive data.
In the oncology field, maintaining quality of life is paramount while patients undergo rigorous treatment regimens. FLIE serves as an objective metric that enables caregivers and researchers to gauge the severity of CINV and its direct effects on various aspects of daily living such as physical activities, social interactions, meal enjoyment, and emotional well-being. By systematically quantifying these impacts, FLIE helps in evaluating the benefits of improved antiemetic regimens, thus guiding better supportive care and treatment plans.
FLIE is composed of a total of 18 items, strategically divided into two domains that address the two primary symptoms observed in CINV:
This section comprises 9 questions focusing on how nausea affects the patient’s daily routines and quality of life. Patients are asked to reflect on their experience of nausea and the subsequent interference with normal activities like eating, socializing, and physical functioning.
Similarly, the vomiting domain includes 9 questions that assess the impact of vomiting episodes. This ensures that both the physical and emotional consequences of frequent vomiting episodes are captured within the measurement structure.
Each of the 18 items in the FLIE questionnaire is typically rated on a 7-point Likert scale. The scoring ranges from 1 (indicating minimal or no effect on daily activities) to 7 (indicating severe impairment). The combined score provides a quantitative measure that enables healthcare professionals to evaluate treatment efficacy over the designated time period.
A lower overall score on the FLIE indicates that the patient’s daily living activities are less impacted by nausea and vomiting. Conversely, higher scores are reflective of more severe detriments in daily functioning, thereby alerting clinicians to the need for adjustments in antiemetic therapy.
The original FLIE was designed with a 3-day recall period, focusing on the acute phase after chemotherapy. However, given the clinical significance of delayed CINV, FLIE has been adapted to include a 5-day recall period. This expansion ensures that the delayed onset of symptoms is equally captured, thereby providing a more holistic view of the patient’s condition over time.
FLIE has been extensively used in clinical trials, serving as both a primary and secondary endpoint in evaluating antiemetic efficacy. Through its consistent deployment across various studies, healthcare providers have been able to:
Several studies have confirmed the FLIE’s internal consistency and construct validity as a measure of CINV’s impact. Its correlation with independent clinical measures and patient diary reports reinforces its credibility as a robust tool in both research and clinical settings. In addition, FLIE has been translated and culturally validated in multiple languages, such as Arabic, ensuring its global applicability and ease of use among diverse patient populations.
Unlike conventional self-diary methods, which may suffer from variability in patient reporting, FLIE offers a systematic questionnaire format that enhances both reliability and validity. Its focus on functional impairment—rather than simply counting the number of symptoms—provides a more nuanced understanding of how CINV disrupts everyday living.
| Feature | Description |
|---|---|
| Questionnaire Items | 18 items divided into two domains: 9 on nausea, 9 on vomiting |
| Domains | Nausea and Vomiting |
| Likert Scale | Typically a 7-point scale ranging from 1 (no impact) to 7 (severe impact) |
| Recall Period | Originally 3 days; some versions extended to 5 days to cover acute and delayed phases |
| Purpose | To evaluate the impact of CINV on daily living functions and overall quality of life |
| Validation | Validated across multiple languages and clinical settings with strong correlation to other PRO measures |
The FLIE questionnaire is designed to capture the significant ways in which CINV affects the routine aspects of a patient’s life. By focusing on how symptoms hinder daily functionality—such as meal preparation, household responsibilities, and recreational activities—FLIE provides healthcare professionals with actionable information. This data is pivotal when tailoring individualized antiemetic treatments intended to restore normalcy in patient lives.
The objective measurement of symptom impact provided by FLIE has led to advancements in antiemetic treatment strategies. Clinicians can compare FLIE scores before and after therapeutic interventions, thereby identifying the most effective approaches for minimizing CINV-related disruptions. Studies have shown that improving symptoms as measured by FLIE correlates with better overall treatment adherence and enhanced patient satisfaction.
Careful translation and cultural validation of the FLIE instrument allow its adoption in diverse regions worldwide. Consistency in measurement outcomes across different linguistic groups affirms that FLIE is a universally applicable tool. This extensive adaptability ensures that the instrument remains relevant regardless of the patient’s cultural background, contributing to more equitable healthcare delivery.
FLIE is not only utilized in clinical trials but also integrated into routine patient care monitoring programs. By regularly assessing patients’ FLIE scores, healthcare teams can promptly detect any deterioration in quality of life and modify treatment plans accordingly. This proactive approach helps to maintain a high standard of care, closely aligned with patient-reported outcomes.