January 1998 ~ Volume 6, Number 1


Instrument Development:
Migraine-Specific Quality of Life Measure (MSQOL)

By Donald L. Patrick, PhD, MSPH and Bryan C. Hurst, MPhil

Migraine is a common neurological disorder characterized by a throbbing, unilateral headache and is often associated with nausea, vomiting, phonophobia and photophobia. Attacks may be preceded by an aura in which transient focal neurological symptoms, usually visual disturbances, occur.1 Therapy for migraine consists of acute treatment to abort attacks.

For patients who suffer approximately two or more attacks per month, treatment may include prophylactic medication or behavioral/environmental changes to prevent attacks. Despite the variety of available therapies, both acute treatment and prophylaxis are unsatisfactory for many migraineurs.

Migraines have been found to have a significant impact on patient functioning and quality of life, including the distress of not being able to carry out normal daily functions such as caring for children and continuing with work.2,3 These effects are not only brought about by intense pain, but also by loss of control over the occurrence of the attacks and fear of when the next headache attack will occur. The subjective nature of the pain experienced by migraineurs and the lack of either physical findings or increased mortality have contributed to the difficulty in assessing the impact of migraine headaches on patients and society.

Quality-of-life instruments provide a means by which subjective evaluations of the effects of a condition and its treatment in relation to a person's goals, values, and expectations can be measured. The quality-of-life data obtained from the Medical Outcomes Study instrument (SF-20) demonstrate that chronic headache disorders are associated with significant limitations in patient well-being and function.4,5 Instruments such as the SF-20 and the SF-36 are generic measures, and contain items which may be completely unrelated to headache, e.g., walking more than a mile. These instruments are most useful in discriminating and making comparisons of different disease states for determining severity of disease impact and cross-condition comparisons. Disease-specific instruments can assess limitations or restrictions associated with particular disease states, and they may, therefore, be more responsive to minimally significant changes.6

There are two strategies for evaluating health-related quality of life (HRQoL) in patients with migraine; 1) during attacks, and 2) long term effects. The underlying assumptions about the patients' quality of life in each case is quite different. Migraine-specific symptom measures have been used by researchers to measure QOL during an attack.7 This brief validated migraine-specific measure has been developed to assess quality-of-life decrement associated with an acute migraine attack in the 24-hour period following headache onset.

To measure long-term effects of migraine and migraine treatment on quality of life, and develop a measure based on a formal conceptual structure for assessing quality of life in persons with migraine, we developed and validated the Migraine-Specific Quality-of-life (MSQOL) instrument.8*

Early decisions made regarding the development of the MSQOL were based in a conceptual model of HRQoL where symptoms, functional status, perceived quality of life and social disability are distinguished as separate components of HRQoL.6 In this multidimensional approach, assessment of disease and treatment outcomes may include measures of all these concepts and their relationships. Health-related quality of life, however, can be distinguished from general, perceived quality of life, and a condition such as migraine headaches can over time affect aspects of life that may not be considered "health-related" by persons with the condition. Perceived quality of life is defined according to a needs-based model9,10 that identifies quality of life as the degree to which most or all human needs are met. This approach is similar to that developed by the World Health Organization in the cross-cultural development of a generic quality-of-life measure.11 The WHOQOL group defined quality of life as individuals' perceptions of their position in life in the context of the culture and value systems in which they live, and in relation to their goals, expectations, standards, and concerns. The MSQOL was conceived to be such a quality-of-life measure specific to persons with migraine and including all the human concerns related to those symptoms.

During the qualitative development of the MSQOL, potential items were grouped into five domains: feelings; avoidance behaviors; worry/anxiety; relationships and global. Subsequent analyses established three domains of avoidance, feelings, and relationships along with an overall score. Development of the MSQOL proceeded with the following steps:

1) Review of the literature and existing instruments,

2) Establishment of a conceptual framework,

3) Elicitation of QOL items,

4) Evaluation of the cross-cultural equivalence,

5) Development and refinement of the draft MSQOL questionnaire,

6) Evaluation of the psychometric properties,

7) Evaluation of responsiveness,

8) Preparation of user's manual and scoring program, and

9) Submission to the Medical Outcomes Trust for approval and distribution.

 

To date, the US version of the MSQOL has been tested both prior to use in clinical trials and during three different large clinical studies involving treatment and repeated measures. This permits evaluation of the MSQOL's ability to discriminate among known groups, and to test its internal consistency, reproducibility, construct validity, interpretability, responsiveness, and effect size for clinical trial use. In summary, research and evaluation studies of the MSQOL to date include the following:

These results suggest that the MSQOL is a responsive measure of quality of life to the treatment of migraine headaches. A more detailed description of these studies is available from the Trust.

The 20-item MSQOL takes approximately 5-10 minutes to self-administer. A scoring program has been developed and the instructions, syntax and a test dataset are contained in the User's Manual available through the Medical Outcomes Trust.12 The instrument is available in U.K. English and has been culturally adapted into Italian, Spanish, French, German, Danish and Swedish.

In summary, the MSQOL has the potential to provide valuable information on the quality of life of migraineurs and to be a useful adjuvant measure when assessing the long-term outcomes of treatment for migraine headaches.

* MSQOL US Version: University of Washington (1997) USA. All rights reserved. US Version Licensed to Zeneca Pharmaceuticals

** Zomig is a trademark of the Zeneca group of companies

References

1. Blau JN, Migraine prodromes separated from the aura: complete migraine. British Medical Journal, 1980;45:223-6.

2. Blau JN, Fears aroused in patients by migraine. Br Med J (Clin Res). 1984;288-1126.

3. Jansen K, Tfelt-Hansen P, Lauritzen M, Olesen J. Classic Migraine. A prospective recording of symptoms. Acta Neurol Scand. 1986;73:359-62.

4. Solomon GD, Skobieranda FG, Gragg LA. Quality of life and well being of headache patients: Measurement by the Medical Outcomes Study Instrument. Headache. 1993;33:351-8.

5. Solomon GD, Skobieranda FG, Gragg LA. Does quality of life differ among headache diagnoses? Analysis using the Medical Outcomes Study Instrument. Headache. 1994;34:143-7.

6. Patrick DL, Erickson P. Health status and: Quality of life in health care evaluation and resource allocation. New York: Oxford University Press; 1993.

7. Santanello NC, Hartmaier SL, Epstein RS, Silberstein SD. Validation of a new quality-of-life questionnaire for acute migraine headache. 1995 Headache 35:330-337

8. Wagner TH, Patrick DL, Galer BS, Berzon RA. A new instrument to assess the long-term quality-of-life effects from migraine: Development and psychometric testing of the MSQOL. Headache. 1996;36:484-492.

9. Patrick DL, Danis ML, Southerland LI, Hong G. Quality of life following intensive care. Journal of General Internal Medicine. 1988;3(3):218-223.

10. McKenna SP. A new theoretical approach to the measurement of quality of life. Drug Inf J. 1994;28:13-18.

11. The WHOQOL Group. The development of the World Health Organization quality-of-life assessment instrument (the WHOQOL). In J.Orley & W. Kuyken (Eds.), Quality-of-life assessment : International Perspectives. Berlin, Germany: Springer-Verlag. 1994.

12. Patrick DL, Martin ML, Bushnell DM. A Quality-of-Life Measure for Persons with Migraine: User's Manual and Scoring Diskette for United States Version. Seattle, Washington: Health Research Associates, Inc., 1998.


1998 MEDICAL OUTCOMES TRUST