Appendix BAnalytical Framework

Publication Details

PICOTS Framework

Population(s)

Adults with episodic migraine, chronic daily headache, or chronic migraine as defined by the Headache Classification Subcommittee of the International Headache Society1 (see below for definitions).

Patient characteristics that can modify the effects of pharmacological treatments for preventing migraine attacks in children and adults:

Age

Sex

Pregnancy

Hormone-based birth control and hormone replacement

The onset of menarche and menopause

Race and ethnicity

Socioeconomic status

Education

Family history

Access to care, type of care, and residence in rural or urban areas

Definition of migraine

Presence of aura

Headache frequency

Prior treatments; overuse of drugs for acute migraine

Obesity

Nutritional and dietary factors, specifically caffeine

Aerobic fitness

Previous head injury

Psychological factors and social/family support system

Comorbidities (depression, bipolar disorder, anxiety, diabetes, hypertension, cardiovascular diseases, others)

Concomitant medications for comorbid conditions

Interventions

Drugs approved by the FDA (such as propranolol, timolol, topiramate, and divalproex sodium) to prevent episodic migraine and to treat chronic migraine (such as Botox).

Off-label medications available in the United States and previously examined in clinical trials for preventing migraine.

Monotherapy.

Multidrug interventions.

Combined pharmacological with nonpharmacological modalities: behavioral interventions with education, exercise, biofeedback, relaxation techniques, yoga, massage, acupuncture, and dietary supplements.

Comparators

Placebo.

Drug treatments (comparative effectiveness).

Nonpharmacological treatments: behavioral interventions with education, exercise, biofeedback, relaxation techniques, yoga, massage, acupuncture, and dietary supplements.

Outcomes

Patient-centered outcomes:

  • Reduction of migraine attacks by >50 percent from baseline; primary outcome for the review.
  • Quality of life.
  • Patient satisfaction.
  • Composite patient centered outcomes defined as an aggregate improvement of the aforementioned outcomes.
  • Emergency visits, loss of work days; treatment failure.

Intermediate outcomes:

  • Number of headache days.
  • Number of moderate to severe headache days.
  • Improvement in associated symptoms.
  • Use of drugs for acute migraine (prescribed or over-counter).
  • Physician/healthcare professional (HCP) visits.

Harms:

  • All reported adverse reactions and effects (such as anxiety, nausea, vomiting, sleep time reduction, drowsiness, or weakness).
  • Treatment discontinuation due to adverse effects.
  • Additional medical resource utilization to manage adverse effects (e.g., prescription medication, urgent care/emergency services, physician/HCP visits).

Timing

6 months or more; optimally 12 months.

Any time of occurrence for the harms.

Setting

Outpatient settings

Definition of Terms

Migraine (as defined by the Headache Classification Subcommittee of the International Headache Society):1

Repeated attacks of headache lasting 4 to 72 hours in patients with a normal physical examination, no other reasonable cause for the headache, and:

  • At least two of the following features:

    Unilateral pain

    Throbbing pain

    Aggravation by movement

    Moderate or severe intensity

  • Plus at least one of the following features:

    Nausea/vomiting

    Photophobia and phonophobia

Episodic migraine as an indication for preventive treatment:

  • Five or more attacks a month2
  • Three or more attacks a month2

Definitions of chronic migraine (can be chronic from onset or transformed from episodic migraine):

  • FDA:

    Chronic migraine is defined as having a history of migraine and experiencing a headache on most days of the month.3

  • Revised International Headache Society criteria for chronic migraine:1
    1.5.1.

    Chronic migraine

    1. Headache (tension-type and/or migraine) on ≥15 days per month for at least 3 months
      * Characterization of a frequently recurring headache generally requires a headache diary to record information on pain and associated symptoms day by day for at least 1 month.
    2. Occurring in a patient who has had at least five attacks.
    3. On ≥8 days per month for at least 3 months headache has fulfilled C.1 and/or C.2 below, that is, has fulfilled criteria for pain and associated symptoms of migraine without aura.
      1. Has at least two of a–d
        1. Unilateral location
        2. Pulsating quality
        3. Moderate or severe pain intensity
        4. Aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) and at least one of (1) or (2):
          1. Nausea and/or vomiting
          2. Photophobia and phonophobia
      2. Treated and relieved by triptan(s) or ergot before the expected development of C.1 above
    4. No medication overuse and not attributed to another causative disorder
      Headache Classification Committee criteria for a medication overuse headache (A8.2)1
Table 1. Pharmacological classes for migraine prevention.

Table 1

Pharmacological classes for migraine prevention.

Table 2. Bayesian models summary under the noninformative prior.

Table 2

Bayesian models summary under the noninformative prior.

Table 3. Winbug Code for Bayesian network meta analysis (PDF, 1.0M)

References

1.
Olesen J, Bousser MG, Diener HC, et al. New appendix criteria open for a broader concept of chronic migraine. Cephalalgia. 2006 Jun;26(6):742–6. [PubMed: 16686915]
2.
Goadsby PJ, Raskin NH. Chapter 15 Headache. In: Fauci AS, Braunwald E, Kasper DL, Hauser SL, Longo DL, Jameson JL, et al., editors. Harrison’s principles of internal medicine. 17th ed. New York: The McGraw-Hill Companies; 2008.
3.
Administration USFaD. FDA News Release: FDA approves Botox to treat chronic migraine. [Accessed on February 1 2011]. http://www​.fda.gov/NewsEvents​/Newsroom/PressAnnouncements​/ucm229782.htm.