The headache under-response to treatment (HURT) questionnaire, an outcome measure to guide follow-up in primary care: development, psychometric evaluation and assessment of utility.

BACKGROUND: Headache disorders are both common and burdensome but, given the many people affected, provision of health care to all is challenging. Structured headache services based in primary care are the most efficient, equitable and cost-effective solution but place responsibility for managing most patients on health-care providers with limited training in headache care. The development of practical management aids for primary care is therefore a purpose of the Global Campaign against Headache. This manuscript presents an outcome measure, the Headache Under-Response to Treatment (HURT) questionnaire, describing its purpose, development, psychometric evaluation and assessment for clinical utility. The objective was a simple-to-use instrument that would both assess outcome and provide guidance to improving outcome, having utility across the range of headache disorders, across clinical settings and across countries and cultures. METHODS: After literature review, an expert consensus group drawn from all six world regions formulated HURT through item development and item reduction using item-response theory. Using the American Migraine Prevalence and Prevention Study's general-population respondent panel, two mailed surveys assessed the psychometric properties of HURT, comparing it with other instruments as external validators. Reliability was assessed in patients in two culturally-contrasting clinical settings: headache specialist centres in Europe (n = 159) and primary-care centres in Saudi Arabia (n = 40). Clinical utility was assessed in similar settings (Europe n = 201; Saudi Arabia n = 342). RESULTS: The final instrument, an 8-item self-administered questionnaire, addressed headache frequency, disability, medication use and effect, patients' perceptions of headache "control" and their understanding of their diagnoses. Psychometric evaluation revealed a two-factor model (headache frequency, disability and medication use; and medication efficacy and headache control), with scale properties apparently stable across disorders and correlating well and in the expected directions with external validators. The literature review found few instruments linking assessment to clinical advice or suggested actions: HURT appeared to fill this gap. In European specialist care, it showed utility as an outcome measure across headache disorders. In Saudi Arabian primary care, HURT (translated into Arabic) was reliable and responsive to clinical change. CONCLUSIONS: With demonstrated validity and clinical utility across disorders, cultures and settings, HURT is available for clinical and research purposes.

Recommendations for headache service organisation and delivery in Europe.

Headache disorders are a major public-health priority, and there is pressing need for effective solutions to them. Better health care for headache-and ready access to it-are central to these solutions; therefore, the organisation of headache-related services within the health systems of Europe becomes an important focus. These recommendations are the result of collaboration between the European Headache Federation and Lifting The Burden: the Global Campaign against Headache. The process of development included wide consultation. To meet the very high level of need for headache care both effectively and efficiently, the recommendations formulate a basic three-level model of health-care organisation rationally spread across primary and secondary health-care sectors, taking account of the different skills and expertise in these sectors. They recognise that health services are differently structured in countries throughout Europe, and not always adequately resourced. Therefore, they aim to be adaptable to suit these differences. They are set out in five sections: needs assessment, description of the model, adaptation, standards and educational implications.

Proposals for new standardized general diagnostic criteria for the secondary headaches.

Headache classification is a dynamic process through clinical testing and re-testing of current and proposed criteria. After publication of the second edition of the International Classification of Headache Disorders (ICHD-II), need arose for revisions in the classification of medication overuse headache and chronic migraine. These changes made apparent a further need for broader revisions to the standard formulation of diagnostic criteria for the secondary headaches. Currently, the fourth criterion makes impossible the definitive diagnosis of a secondary headache until the underlying cause has resolved or been cured or greatly ameliorated by therapy, at which time the headache may no longer be present. Given that the main purpose of diagnostic criteria is to enable a diagnosis at the onset of a disease in order to guide treatment, this is unhelpful in clinical practice. In the present paper we propose maintaining a standard approach to the secondary headaches using a set of four criteria A, B, C and D, but we construct these so that the requirement for resolution or successful treatment is removed. The proposal for general diagnostic criteria for the secondary headaches will be entered into the internet-based version of the appendix of ICHD-II. During 2009 the Classification Committee will apply the general criteria to all the specific types of secondary headaches. These, and other changes, will be included in a revision of the entire classification entitled ICHD-IIR, expected to be published in 2010. ICHD-IIR will be printed and posted on the website and will be the official classification of the International Headache Society. Unfortunately, it will be necessary to translate ICHD-IIR into the many languages of the world, but the good news is that no major changes to the headache classification are then foreseen for the next 10 years. Until the printing of ICHD-IIR, the printed ICHD-II criteria remain in place for all other purposes. We issue a plea to the headache community to use and study these proposed general criteria for the secondary headaches in order to provide more evidence for their utility-before their incorporation in the main body of the classification.

Validity and reliability of the Migraine-Treatment Optimization Questionnaire.

Our aim was to establish the validity and reliability of a patient-rated Migraine Treatment Optimization Questionnaire (M-TOQ) in primary care. Patients who met International Classification of Headache Disorders, 2nd edn criteria for migraine completed a 19-item questionnaire containing candidate items for the M-TOQ, and three questionnaires designed to test convergent/construct validity [Migraine Disability Assessment Scale (MIDAS), Headache Impact Test (HIT)-6 and Migraine-Specific Quality of Life Scale (MSQoL)]. A 15-item (M-TOQ-15) and a five-item (M-TOQ-5) questionnaire were derived. Two hundred and fifty-three adult patients were recruited. Five treatment optimization domains were identified: functioning, rapid relief, consistency of relief, risk of recurrence and tolerability; with Cronbach alphas of 0.70-0.84. The Cronbach alpha for M-TOQ-15 was 0.85, and it correlated well with MIDAS, HIT-6 and MSQoL (r = 0.33-0.44). The Cronbach alpha for M-TOQ-5 was 0.66, and it also correlated well with the three questionnaires (r = 0.33-0.41). The utility of the M-TOQ for assessing treatment benefit in research (M-TOQ-15) and primary care (M-TOQ-5) should be further validated.

Consensus for tinnitus patient assessment and treatment outcome measurement: Tinnitus Research Initiative meeting, Regensburg, July 2006.

There is widespread recognition that consistency between research centres in the ways that patients with tinnitus are assessed and outcomes following interventions are measured would facilitate more effective co-operation and more meaningful evaluations and comparisons of outcomes. At the first Tinnitus Research Initiative meeting held in Regensburg in July 2006 an attempt was made through workshops to gain a consensus both for patient assessments and for outcome measurements. It is hoped that this will contribute towards better cooperation between research centres in finding and evaluating treatments for tinnitus by allowing better comparability between studies.

Time course of adverse events most commonly associated with topiramate for migraine prevention.

The efficacy, safety and tolerability of topiramate has been demonstrated in three large multicenter, randomized, double-blind, placebo-controlled trials. To characterize the time course of adverse events (AEs) that led to treatment discontinuation in >/=2% of patients who received topiramate 100 mg/day during three pivotal, multicenter, randomized, double-blind, placebo-controlled, and 26-week trials. The pooled population comprised all randomized patients who reported safety data during the double-blind phase (topiramate 100 mg/day, n = 386; placebo n = 372), which consisted of a 4-week titration period and a 22-week maintenance period. Incidence, time to onset, and cumulative mean rate of AEs were assessed. Overall, AEs led to treatment discontinuation in 24.9% of patients receiving topiramate 100 mg/day and 11.0% receiving placebo (P < 0.001). AEs leading to discontinuation during the double-blind phase in > or =2% of patients included paresthesia (8.0% discontinued), any cognitive symptoms (7.3% discontinued), fatigue (4.7% discontinued), insomnia (3.4% discontinued), nausea (2.3% discontinued), loss of appetite, anxiety, and dizziness (2.1% discontinued because each AE). Most AEs began during the titration period. Paresthesia, any cognitive symptoms, nausea, and loss of appetite occurred at a higher rate in the topiramate group than in the placebo group (P < 0.01). AEs leading to discontinuation of topiramate are probably to occur during dose titration. If a patient has not experienced one of these AEs within the first 6 weeks of initiating topiramate 100 mg/day, these AEs are unlikely to occur.

Crossover, double-blind clinical trial comparing almotriptan and ergotamine plus caffeine for acute migraine therapy.

In this randomized, double-blind, crossover clinical trial, adult patients treated two migraine attacks: one with almotriptan 12.5 mg and the other with ergotamine 2 mg plus caffeine 200 mg. Treatment with almotriptan was associated with a significantly greater proportion of patients achieving 2-h pain free (20.9% vs. 13.7%; P < 0.05) and 2-h pain relief (57.7% vs. 44.5%; P < 0.01) compared with ergotamine plus caffeine therapy; significant differences were not seen at 1 h. Rates for sustained pain free and sustained pain free plus no adverse events (AEs) also were significantly greater after almotriptan treatment than after the use of ergotamine plus caffeine (P < 0.05). Almotriptan was associated with a significantly lower rate of photophobia at 90 min (P < 0.05), phonophobia at 60, 90, and 120 min (P < 0.05 to <0.01), and nausea and vomiting at 90 and 120 min (P < 0.01) compared with ergotamine plus caffeine. A significantly greater proportion of patients were more satisfied with almotriptan than with ergotamine plus caffeine (P < 0.05). Sixteen patients reported adverse events during almotriptan treatment and 27 patients reported AEs during the ergotamine plus caffeine therapy. Most AEs were mild-to-moderate and did not result in treatment-related discontinuations. In conclusion, almotriptan was associated with significantly greater efficacy for treating migraine compared with ergotamine plus caffeine, was generally well tolerated and was associated with greater rate of treatment satisfaction.

[Impact of several illnesses on health related quality of life on workers]. / Impacto de distintas enfermedades en la calidad de vida relacionada con la salud (CVRS) en una población laboral.

UNLABELLED: FOUNDATION AND OBJECTIVE: To make a comparative study of the degree of impact of different diseases in the health related quality of life (HRQoL) of workers. MATERIAL AND METHODS: A questionnaire including the measure of HRQoL SF-36, was sent by mail and fulfilled by employees of the Pfizer company in Spain. Differences in the impact in HRQoL between subjects with and without several characteristics, with less or more degree of work productivity and with and without antecedents of several diseases and current treatment, were assessed by means of statistical tests of U Mann-Whitney and Kruskal-Wallis. RESULTS: In a sample of 399 valuable subjects, 35.8+/-6.5 years (mean+/-standard deviation), with a 63.7% of men, worst HRQoL scores in the Physical Summary Component of SF-36 were observed among subjects with history of some disease (52.6+/-5.9 days versus 55.9+/-2.6), migraine (46.2+/-5.9 versus 54.7+/-4.1), musculoskeletal (49.7+/-7.2 versus 53.9+/-5.1) and digestive diseases (51.5+/-6.6 versus 54.1+/-4.9), and/or taking some current treatment (50.2+/-6.4 versus 55.0+/-4.4); p <0.05 for all comparisons. In the Physical Summary Component of SF-36 worst HRQoL scores were observed among subjects with history of some disease (51.4+/-7.1 versus 53.4+/-5.9), digestive (49.9+/-8.3 versus 52.5+/-6.3) and mental disorders (46.0+/-8.8 versus 52.4+/-6.4); p <0.05 for all comparisons. CONCLUSIONS: The impact of the disease in the HRQoL was associated to the type of pathological antecedents, being migraine that hit more negatively in the Physical Health, and mental disorders in the Mental Health.

Impacto de distintas enfermedades en la calidad de vida relacionada con la salud (CVRS) en una población laboral / Impact of several illnesses on health related quality of life on workers

Fundamento y objetivo: Realizar un estudio comparativo del grado de impacto de distintas enfermedades en la calidad de vida relacionada con la salud (CVRS) en el medio laboral. Material y métodos: Un cuestionario incluyendo el cuestionario de CVRS SF-36, fue enviado por correo y cumplimentado por empleados de Pfizer España. Se evaluaron diferencias en el impacto en la CVRS entre sujetos con/sin distintas características, según grado de productividad laboral, y según con/sin antecedentes de distintas enfermedades y notoma/ toma actual de tratamiento mediante pruebas estadísticas U Mann- Whitney y Kruskal-Wallis. Resultados: En una muestra de 399 sujetos valorables, de 35,8±6,5 años (media±desviación típica), un 63,7% hombres, se observaron peores puntuaciones en el Índice de Salud Física en sujetos con antecentes de alguna enfermedad (52,6±5,9 días versus 55,9±2,6), migraña (46,2±5,9 versus 54,7±4,1), patologías musculoesqueléticas (49,7±7,2 versus 53,9±5,1) y del sistema digestivo (51,5±6,6 versus 54,1±4,9), y toma de algún tratamiento (50,2±6,4 versus 55,0±4,4); p<0,05 en todas las comparaciones. En el Índice de Salud Mental se observaron peores puntuaciones en sujetos con antecedentes de alguna enfermedad (51,4±7,1 versus 53,4±5,9), enfermedades del sistema digestivo (49,9±8,3 versus 52,5±6,3) y trastornos mentales (46,0±8,8 versus 52,4±6,4); p<0,05 en todas las comparaciones. Conclusiones: El impacto de la enfermedad en la CVRS se asoció al tipo de antecedentes patológicos, siendo la migraña la patología que impacta más negativamente en la Salud Física, y los trastornos mentales en la Salud Mental

Foundation and objective: To make a comparative study of the degree of impact of different diseases in the health related quality of life (HRQoL) of workers. Material and methods: A questionnaire including the measure of HRQoL SF-36, was sent by mail and fulfilled by employees of the Pfizer company in Spain. Differences in the impact in HRQoL between subjects with and without several characteristics, with less or more degree of work productivity and with and without antecedents of several diseases and current treatment, were assessed by means of statistical tests of U Mann-Whitney and Kruskal-Wallis. Results: In a sample of 399 valuable subjects, 35.8±6.5 years (mean±standard deviation), with a 63.7% of men, worst HRQoL scores in the Physical Summary Component of SF-36 were observed among subjects with history of some disease (52.6±5.9 days versus 55.9±2.6), migraine (46.2±5.9 versus 54.7±4.1), musculoskeletal (49.7±7.2 versus 53.9±5.1) and digestive diseases (51.5±6.6 versus 54.1±4.9), and/or taking some current treatment (50.2±6.4 versus 55.0±4.4); p<0.05 for all comparisons. In the Physical Summary Component of SF-36 worst HRQoL scores were observed among subjects with history of some disease (51.4±7.1 versus 53.4±5.9), digestive (49.9±8.3 versus 52.5±6.3) and mental disorders (46.0±8.8 versus 52.4±6.4); p<0.05 for all comparisons. Conclusions: The impact of the disease in the HRQoL was associated to the type of pathological antecedents, being migraine that hit more negatively in the Physical Health, and mental disorders in the Mental Health

New appendix criteria open for a broader concept of chronic migraine.

After the introduction of chronic migraine and medication overuse headache as diagnostic entities in The International Classification of Headache Disorders, Second Edition, ICHD-2, it has been shown that very few patients fit into the diagnostic criteria for chronic migraine (CM). The system of being able to use CM and the medication overuse headache (MOH) diagnosis only after discontinuation of overuse has proven highly unpractical and new data have suggested a much more liberal use of these diagnoses. The International Headache Classification Committee has, therefore, worked out the more inclusive criteria for CM and MOH presented in this paper. These criteria are included in the appendix of ICHD-2 and are meant primarily for further scientific evaluation but may be used already now for inclusion into drug trials, etc. It is now recommended that the MOH diagnosis should no longer request improvement after discontinuation of medication overuse but should be given to patients if they have a primary headache plus ongoing medication overuse. The latter is defined as previously, i.e. 10 days or more of intake of triptans, ergot alkaloids mixed analgesics or opioids and 15 days or more of analgesics/NSAIDs or the combined use of more than one substance. If these new criteria for CM and MOH prove useful in future testing, the plan is to include them in a future revised version of ICHD-2.

Preference for rizatriptan 10-mg wafer vs. eletriptan 40-mg tablet for acute treatment of migraine.

Preference is a composite, patient-oriented endpoint incorporating efficacy, tolerability, formulation, and convenience of medications. The objective of this study was to compare patient preference for rizatriptan 10-mg wafer vs. eletriptan 40-mg tablet for acute treatment of migraine. In this multicentre, open-label, two-period, crossover study, out-patients were randomly assigned to treat the first of two moderate to severe migraines with rizatriptan or eletriptan and the second with the alternate therapy. Patients completed diary assessments at baseline and up to 24 h after taking study medication. At the last visit, patients completed a psychometrically validated preference questionnaire. A total of 372 patients (mean age 38 years, 85% female) treated two migraine attacks, and 342 patients (92%) expressed a preference for treatment. Significantly more (P < or = 0.001) patients preferred rizatriptan 10-mg wafer [61.1%; 95% confidence interval (CI) 55.7, 66.3] to eletriptan 40-mg tablet (38.9%; 95% CI 33.7, 44.3). The most common reason given for preference of either treatment was speed of headache relief. At 2 h, 80% and 69% of patients reported that rizatriptan and eletriptan, respectively, was convenient or very convenient to take (mean convenience score 1.99 vs. 2.31, respectively; P < or = 0.001). Both triptans were well tolerated. In this head-to-head study designed to evaluate global patient preference, significantly more patients preferred the rizatriptan 10-mg wafer to the eletriptan 40-mg tablet for acute treatment of migraine. The single most important reason for preference was speed of relief, consistent with results from previous preference studies.

Placebo response in a patient with chronic migraine and ergotic overuse.

Facilitation of nociceptive systems has been implicated in Chronic-Migraine pathogenesis. Daily consumption of medication may be a contributing factor. The patient was male, aged 76 years, with history of migraine without aura. Six years ago, he presented with a mild-moderate daily pulsating headache. He was overusing analgesics and ergotamine. After withdrawing, the patient started a nonpulsating headache, diffuse and constant. During follow up, he was refractive to several symptomatic and prophylactic treatments. When we treated him with placebo capsules, the headache responded very well. At first, pain-relief occurred for 6 h and progressively, extended. Two years later, when our patient started to use transdermal patches of fentanyl for treatment of a complex regional pain syndrome type 1, his headache did not improve. Patient has maintained prolonged response to placebo. Actually, he is pain-free for 2-3 days with 1 placebo capsule. We discuss mechanisms of chronic-migraine, drug-overuse, drug-induced headache and placebo addiction. Powerful psychological mechanisms could determine response to placebo in this patient.