Probable medications overuse headaches: validation of a brief easy-to-use screening tool in a headache centre
© Dousset et al.; licensee Springer. 2013
Received: 14 February 2013
Accepted: 16 September 2013
Published: 2 October 2013
To validate a rapid questionnaire as a screening tool, because application of the diagnostic revised criteria of the ICHD-II for medication overuse headache (MOH) requires experience for the physician and is time-consuming.
ICHD-II criteria for probable MOH (pMOH) were transformed in questions formulated in such a way that they could be self-administered, easily understood, and quickly filled out. We compared this questionnaire to the gold standard: the diagnosis made by headache specialists, based on the the ICHD-II criteria. Patients who were consulting for pMOH or migraine for the first time were consecutively included. As validity indicators, we calculated sensitivity, specificity, positive and negative predictive values of the items.
Seventy-nine patients were screened, 77 included, 2 female patients excluded. Forty-two patients have been considered as suffering from pMOH, 35 patients suffered from migraine without medication overuse. The association of the question “do you take a treatment for attacks more than 10 days per month” and the question “is this intake on a regular basis?” had a sensitivity of 95.2% and a specificity of 80%.
This screening tool can detect pMOH with a sensitivity that could be of interest to screen patients in clinical practice and to pre-include patients for research as epidemiological studies.
KeywordsMedications overuse headaches Screening tool Validation Questionnaire Sensitivity Specificity
The prevalence of chronic daily headaches with medication overuse is around 1.5% of the general population, with prevalence figures being very similar across different countries. They account for 10% to 78% of patients seen in headache centres . Medication overuse headache (MOH) decreases the quality of life and accounts for reduced efficiency at work. Population-based and clinical data reflects the importance of this public health problem .
The 2nd edition of the International classification of headache disorders (ICHD-II) defined MOH as a migraine-type headache:1 present on ≥15 days per month with at least 1 of the following characteristics: bilateral, pressing/tightening quality, mild or moderate intensity;  associated with use of acute treatment for headache on a regular basis for more than 3 months  that developed or markedly worsened during medication overuse  that resolved or reverted to its previous pattern within 2 months after discontinuation of the offending medication . Subsequent revision proposed to eliminate the headache characteristics  and to delete the last criterion in order to allow the establishment of MOH diagnosis when the patient suffers from the disorder and not only after the medication withdrawal . This change suggested by Olesen has not been officially implemented and correct formulation for MOH before withdrawal should be probable MOH (pMOH). The IHS classification is an explicit clinical criterion so that the diagnosis of pMOH does not require any specific examination that is needed only to exclude a symptomatic origin. Application of the operational diagnostic revised criteria of the ICHD-II allows making the diagnosis on the basis of consumption of medication (number of days monthly) and a worsening of the headache during the time of medication intake. However, this clinical diagnosis with a face-to-face interview is the gold standard and requires clinical experience for the physician, and enough time to question patients precisely, to specify ICHD-II criteria, and to specify the diagnosis of primary headache, more frequently migraine, which has been the basis for the development of the MOH. This is time-consuming.
In this clinical context, a less time consuming tool would be of interest. We have developed a 4 item questionnaire evaluating the frequency of headaches and the amount of medication consumption used to treat the attacks and compared sensitivity and specificity of this in migraine patients and MOH patients. Indeed, such a tool would be useful in clinical practice and for research, to pre-include patients for epidemiological studies.
We evaluated the accuracy of the rapid evaluation of headaches and medication used to treat the attacks consumption in a sample of consecutive headache patients seen at the Bordeaux Headache Centre for their first visit. Our goal was to establish the validity of a brief screening instrument that uses among other things self-reporting of use of acute treatment for headache by the patient and has both the sensitivity and specificity that would make it useful in the outpatient headache centres, and in general practitioner practices. The validity study required the comparison of answers of medication overuse headache sufferers to the answers of migraine sufferers, with the gold standard diagnosis done by two neurologists specialised in headache. The study was conducted in France in the Bordeaux headache centre. Because the setting of intended use was at first pain or headache centres, our validation study occurred in an outpatient headache centre (a specialized headache centre of a teaching hospital).
All men and women aged 18 years or more who were visiting for migraine or probable MOH identified by their general practitioner were consecutively pre included. Pre inclusion required the ability to read and write French. They filled out the questionnaire in the waiting room. Then definitive inclusion was done after the diagnosis of migraine without aura or migraine with aura, or migraine without or with aura plus pMOH by one of the headache specialist during the face-to-face interview according to the 2004 ICHD-II  criteria.
Other primary headaches or secondary headaches were exclusion criteria. Patients were enrolled after providing their informed consent. We did not collect any personal information so that an ethics vote was not necessary.
ICHD-II criteria for PMOH and self questionnaire
ICHD-II criteria for probable MOH
A. Headache present on ≥ 15d/month
1. Do you have headache on ≥ 15 days per month?
B. Regular overuse for > 3 months
2. Do you take a treatment for attacks on ≥ 10 days per month?
1. Ergotamine, triptans, opioids or combination analgesic medications on ≥ 10 days /month on a regular basis for 3 months
3. For more than 3 months?
2. Simple analgesics or any combination of ergotamine, triptans, analgesics opioids on ≥15 D per month on a regular basis for > 3 months
4. Is this intake on a regular basis?
C. Headache has developed or markedly worsened during medication overuse
The gold standard used to test the validity of the questionnaire was the face to face diagnosis of probable MOH made by headache specialists, based on the second edition of the ICHD-II. The gold standard procedure included a medical history, a comprehensive neurological history and examination. Possible organic causes of headache were excluded through a general and a neurological examination and if needed complementary exams. The headache specialist completed a symptom checklist based on ICHD-II criteria and assigned a clinical diagnosis of migraine or migraine plus MOH.
Validity assessment and data analysis
Filling out the questionnaire and the face to face interview were done the same day. As validity indicators, we calculated sensitivity, specificity and the positive and negative predictive values for each pair, trio of item and for the 4 items. The sensitivity corresponded to the percentage of all affirmative answers in the group of patients with MOH (ability of detection of MOH cases). The specificity corresponded to the percentage of negative answers in the group of subjects with migraine (ability of detection of non-suffering MOH patients). The positive predictive value corresponded to the percentage of patients with MOH who screened positive. The negative predictive value corresponded to the percentage of patients without MOH who screened negative. Data analysis was done using SAS 8.2 for windows.
Patients were enrolled between September 2009 and December 2009. Eighty-nine patients have been seen for headache in the headache centre during this period.
Seventy-seven patients were pre-included, with twenty-one men (27.3%) and fifty-six women (72.7%). Ages varied from 16 to 71 years, with mean age of 42.5.
Age, sex and onset for migraine patients and pMOH* patients
n = 35
n = 42
< 10 years
Acetaminophen or NSAID
Next we determined sensitivity, specificity, positive predictive value, negative predictive value for each item, for each pair of item and for the items 1 + 2 + 4.
Sensitivity, specificity, positive predictive values, negative predictive values for each item and for more than one item
Yes for each question
1 + 2
1 + 4
2 + 4
1 + 2 + 4
Concerning patients with pMOH, 19 patients had a duration of medication overuse > 10 years, 13 patients up to 10 years. Duration of pMOH didn’t have any influence on answers to questions. Twenty-four patients had pMOH type 1 as mentioned Saper and Lake , 18 type 2. This had no impact on answers. Eight patients overused acetaminophen or NSAID, 10 overused an association of medications, 14 overused combinations, 9 overused triptans and one ergotamine. The size of the sample did not allow to study the impact of the type of medication on the response profile. Duration of pMOH and classification of pMOH type 1 or 2 had no impact on answers to questionnaire (p = 0.07 and p = 0.01 respectively).
The main results of our study validation was the following: the association of question 2 (do you take a treatment for attacks more than 10 days per month?) and question 4 (is this intake on a regular basis?) had a sensitivity of 95.2% and a specificity of 80%. The advantages of such questions are their simplicity, rapidity, and low cost. Our sample of migraineurs, and of pMOH sufferers were heterogeneous in terms of age, sex, and duration. Moreover, we kept equivocal cases.
Answers to the question concerning the criteria specifying the necessity of having developed a worsening of the headaches during overuse: results of the pilot study in 10 patients suffering from pMOH
Understanding of the question (Yes/No)
Answer to the question
No, because had tried to decrease the intake as early as the worsening of headaches
No, because already tries to decrease drug consumption
Methods used to diagnose MOH in main epidemiological studies
Questions or criteria
Type of questionnaire
Random sample 2252 patients
Face-to-face diagnosis by a neurologist interested in headache
1- Have you ever had headache?
2- Do you have headache tend days or more per month?
Population of a small islet > 65 years-old
Revision HIS criteria proposed by Silberstein
Person-to-person survey method and diagnosis by a neurologist
Random population based survey
Face-to face questionnaire
Then face-to-face diagnosis with a physician
Headache being present for more than 3 days per week in the previous year
Quota sampling approach > 14
Have you ever had headache?
Then face-to-face diagnosis with a physician
Do you have headache 10 or more days per month?
If yes, to other questions: In the last three months have you taken any analgesic for your head pain
All inhabitants of a county of Norway invited to answer to a questionnaire
Headache more than 14 days per month and use of analgesics 4 times per week or more
Then face to face interview by a neurologist
Validated questionnaire: sensitivity 75%, specificity 100%
Adults from 3 German regions
14 single items designed to assess the 2nd ed of IHS, medication overuse classified based on medication intake during the last month.
Face-to-face by trained interviewers
Kappa statistics was calculated: 94.5% indicating excellent inter-rater agreement
Randomized cluster sampling
Two screening questions: headache present on ≥ 15 days per month and using medication for ≥ 10 days per month during the past three months
Then subsequent interview
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