Download The EORTC and FACIT suites at a glance 1

The EORTC QLQ and FACIT suites at a glance
Website
Number of measures (at various stages of
validation)
Development
Items in core measure
Response options
Recall period
Item format
Organisation of items
Domains in core measure
EORTC QLQ
http://www.eortc.be/home/qol/
26
FACIT
http://www.facit.org
48, plus 10 symptom indices
Lit review, expert opinion, patient input 1
30
Likert scales (4 or 7 options)
Past week
Questions
Items are not always grouped into domains and never
explicitly so. The five physical functioning items are grouped
into a Guttman scale and are recognizably measuring the
same construct. Concludes with global health status / quality
of life questions
Lit review, patient and expert opinion 2
27
Likert scale (5 options)
Past 7 days
Statements
Items are explicitly grouped into domains. Concludes with
general quality of life item
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•
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Five functional scales measuring o
Physical functioning (5 items)
o
Role functioning (2 items)
o
Emotional functioning (4 items)
o
Social functioning (2 items)
o
Cognitive functioning (2 items)
Three symptom scales measuring pain, fatigue and
nausea and vomiting (2 items each)
Six single symptom items measuring dyspnea,
insomnia, appetite loss, constipation, diarrhea and
financial impact.
A global health status / quality of life scale (2
items)
•
Four wellbeing scales measuring
o
Physical wellbeing (7 items)
o
Social/family wellbeing (7 items)
o
Emotional wellbeing (6 items)
o
Functional wellbeing (7 items, including global
QOL question)
•
Note – Low correlations observed in several studies suggest that the social subscales of the QLQ-C30 and FACT-G do NOT
measure the same construct 3
Time needed (according to authors) for
completion of core measure
Administration
Free access
11 mins
5 – 10 mins (though research suggests this may be an
underestimate)
Self, interviewer
Self, interviewer, computer
Note – Research suggests HRQOL may be higher when interviewer administered 4
•
Questionnaires (for academic use)
•
Questionnaires
•
References
•
References
•
Scoring manual (includes guidelines on
•
FAQs
interpretation)
•
FAQs
•
Details of EORTC activities and opportunity to get
involved
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Paid access
Questionnaires (for use by pharmaceutical companies)
Modules available
Core measure
EORTC QLQ-C30
Type-specific modules
Validated modules:
• Lung (LC13)
• Breast (BR23)
• Head & Neck (H&N35)
• Oesophageal (OES18)
• Oesophageal, oesophago–gastric junction or
stomach (OG25)
• Ovarian (OV28)
• Gastric (STO22)
• Multiple Myeloma (MY20)
• Cervical cancer module (CX24)
Modules in phase IV:
• Prostate
• Brain
• Colorectal Liver Metastases
• Pancreatic
• Information module
• Peripheral Neuropathy
• Carcinoid / Neuroendocrine tumours
Modules in Phase III:
• Superficial Bladder
• Muscle Invasive Bladder
• Hepatocellular Carcinoma
• High Dose Chemotherapy
• Colorectal
• Ophthalmic
• Chronic Lymphocytic Leukaemia
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Information on –
•
selecting an endpoint
•
assessment timing
•
tracking/compliance
•
non-biasing interview technique
•
Scoring (administration + scoring; scoring options;
raw score templates; SAS + SPSS programs)
•
reliability + validity (reports; effect size calculations)
•
interpreting scores (clinically meaningful change;
normative data; raw score versus T-scores)
General measures
Core (FACT-G), non-life-threatening conditions measure, and
the general population measure.
Cancer-specific measures
Breast; bladder; brain; colorectal; central nervous system;
cervical; esophageal; endometrial; gastric; head & neck;
hepatobiliary; leukemia; lung; lymphoma; melanoma; ovarian;
prostate; vulva; pediatric brain tumor survivors.
Treatment-specific measures
Bone marrow transplantation; biologic response modifiers;
neurotoxicity; taxane therapy.
Symptom-specific measures
Anorexia/cachexia; diarrhea; anemia/fatigue (fatigue is also
available as a 13 item stand-alone subscale); endocrine
symptoms; lymphedema; neutropenia; thrombocytopenia; fecal
incontinence; urinary incontinence.
Non-cancer-specific measures
Palliative care; spiritual well-being; spiritual wellbeing
(expanded); HIV infection; multiple sclerosis; treatment
satisfaction (general); treatment satisfaction (patient);
satisfaction with pharmacist.
Measures under development
Abdominal discomfort; bone pain; cognitive function; liver
transplants.
Symptom indices (to be added on to measures as appropriate)
Breast; bladder; brain; colorectal; head and neck; heptobiliary;
lung; ovarian; prostate; and kidney cancer symptom indices.
Overall score?
Minimal clinically important differences (MCIDs) in
scores
Non-type specific modules
Palliative care (EORTC QLQ-C15-PAL)
In-patient Satisfaction with Care (EORTC IN-PATSAT32)
No. Subscale scores or response to two global questions
only. Work is underway to develop a summative score.
10% of each scale 5-9
Yes, or subscale scores or Trial Outcome Index (PWB + FWB +
module subscale)
Instrument
Scale/subscale
MCID
(points)
FACT-G
PWB
2–3
SWB
NA
EWB
2 (tentative)
FWB
2–3
Total FACT-G
3–7
FACT-Anemia
Fatigue Subscale
3–4
TOI-Fatigue
5
TOI-Anemia
6
Total FACT-Anemia
7
FACT-Breast
Breast cancer
2–3
subscale
TOI-Breast
5–6
Total FACT-Breast
7–8
FACT-Colorectal
Colorectal cancer
2–3
subscale
TOI-Colorectal
4–6
Total FACT5–8
Colorectal
FACT-Head &
Total FACT-Head &
6–12
Neck
Neck
FACT-Lung
Lung cancer subscale 2–3
TOI-Lung
5–6
10
Languages
Other illnesses?
Other
80
No – cancer specific
•
•
More widely used (over 3,000 studies to date)
Assesses cognitive domain and financial impact
> 50
Yes – The suite includes generic measures for those with
chronic illness (e.g. spiritual wellbeing) as well as two diseasespecific measures (multiple sclerosis and HIV infection)
•
•
•
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More detailed assessment of social and emotional wellbeing
More data available regarding meaningful differences
in scores
Appropriate for use in patients with a variety of chronic
health conditions, and in the general population
References
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Aaronson NK, Cull A, Kaasa S, Sprangers MA. The European Organisation for Research and treatment of Cancer (EORTC) modular approach to
quality of life assessment in oncology: An update. In: Spilker B, ed. Quality of life and pharmacoeconomics in clinical trials. Philadelphia:
Lippincott-Raven; 1996:179-188.
Cella DF, Tulsky DS, Gray G, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure.
Journal of Clinical Oncology. 1993;11(570-579).
Holzner B, Bode RK, Hahn EA, et al. Equating EORTC QLQ-C30 and FACT-G scores and its use in oncological research. European Journal of
Cancer. Dec 2006;42(18):3169-3177.
Cheung YB, Goh C, Thumboo J, Khoo K-S, Wee J. Quality of life scores differed according to mode of administration in a review of three major
oncology questionnaires. Journal of Clinical Epidemiology. Feb 2006;59(2):185-191.
Doyle C, Crump M, Pintilie M, Oza AM. Does palliative chemotherapy palliate? Evaluation of expectations, outcomes, and costs in women
receiving chemotherapy for advanced ovarian cancer. Journal of Clinical Oncology. Mar 1 2001;19(5):1266-1274.
Nordin K, Steel J, Hoffman K, Glimelius B. Alternative methods of interpreting quality of life data in advanced gastrointestinal cancer patients.
British Journal of Cancer. Nov 2 2001;85(9):1265-1272.
Gulbrandsen N, Hjermstad MJ, Wisloff F, Nordic Myeloma Study G. Interpretation of quality of life scores in multiple myeloma by comparison with
a reference population and assessment of the clinical importance of score differences. European Journal of Haematology. Mar 2004;72(3):172180.
King MT. The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30. Quality of Life Research. Dec 1996;5(6):555-567.
Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. Journal of Clinical
Oncology. Jan 1998;16(1):139-144.
Webster K, Cella D, Yost KJ. The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: properties, applications, and
interpretation. . Health Qual Life Outcomes. 2003:1:79.
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