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Background and Purpose

Chronic migraine (CM) has a significant impact on daily activities, and analgesic overuse is a major contributing factor to migraine transformation. Limited information is available on the functional consequences of CM stemming from analgesic overuse. This study evaluated the impact of the frequency of analgesic medication use on headache-related disability and clinical features in patients with CM.

Methods

Patients with CM were enrolled consecutively and classified into two groups according to their frequency of medication use: <15 days/month (CM-ML, n=52) and ≥15 days/month (CM-MH, n=68). All patients completed a structured questionnaire concerning the clinical features of their migraine, a validated version of the Migraine Disability Assessment questionnaire (MIDAS), and the Headache Impact Test-6 (HIT-6).

Results

The pain intensity, as measured by a visual analog scale, was greater in the CM-MH group than in the CM-ML group (8.5±0.2 vs. 7.7±0.3, mean±SD; p<0.05). In the disability domain, the MIDAS scores were significantly higher for CM-MH patients than for CM-ML patients (47.6±4.8 vs. 26.8±4.5, p<0.01). The impact from migraine, as measured by the HIT-6, was greater for CM-MH patients than for CM-ML patients (65.6±1.0 vs. 62.1±1.0, p<0.05).

Conclusions

Our results indicate that the headache pain intensity and disability are greater in patients with CM who use medication frequently.

Objective: The purpose of this study was to assess psychometric properties of the six-item Headache Impact Text (HIT-6™) across episodic and chronic migraine.

Methods: Using a migraine screener and number of headache days per month (HDPM), participants from the National Survey of Headache Impact (NSHI) study and the HIT-6 validation study (HIT6-V) were selected for this study. Eligible participants were categorized into three groups: chronic migraine (CM: ≥ 15 HDPM); episodic migraine (EM: < 15 HDPM); non-migraine headaches. Reliability and validity of the HIT-6 were evaluated.

Results: A total of 2,049 survey participants met the inclusion/exclusion criteria for this study. Participants were identified as 6.4% CM; 42.1% EM; 51.5% non-migraine, with respective mean HIT-6 scores: 62.5 ± 7.8; 60.2 ± 6.8; and 49.1 ± 8.7. High reliability was demonstrated with internal consistency (time1/time2) of 0.83/0.87 in NSHI, and 0.82/0.92 in HIT6-V. Intra-class correlation for test-retest reliability was very good at 0.77. HIT-6 scores correlated significantly (p < .0001) with total Migraine Disability Assessment Scale scores (r = 0.56), headache pain severity (r = 0.46), and HDPM (r = 0.29). Discriminant validity analysis showed significantly different HIT-6 scores (F = 488.02, p < .0001) across the groups.

Conclusion: Results from these analyses confirm that the HIT-6 is a reliable and valid tool for discriminating headache impact across episodic and chronic migraine.

Background and Purpose

Complete information on migraine-related disabilities facilitate the making of appropriate treatment decisions. Although the accessibility and ease of use of the Headache Impact Test-6 (HIT-6) make it a very promising instrument, there are few data available for comparing HIT-6 scores with the actual amount of disability.

Methods

To determine whether the disability measured using the HIT-6 questionnaire realistically reflects the amount of disability as extracted from a headache diary, which would help when deciding a management plan, 130 patients with migraine without aura were instructed to complete a headache diary on the days on which headache occurred. Each diary booklet also contained questions on the resulting disability, and comprised five items originating from the Migraine Disability Assessment Scale. After submitting their diaries, the participants completed the HIT-6 for the same time period.

Results

Disability as recorded in diaries was present for a mean of 2.7 days per month, and its duration differed significantly with HIT-6 score: 0.9, 2.6, and 4.6 days per month for littleto-no impact, moderate impact, and severe impact, respectively. The summed disability score from diaries was also related to the HIT-6 score. Headache frequency was the only headache characteristic that contributed significantly to the HIT-6 score.

Conclusions

This study demonstrates that the HIT-6 could be useful for assessing headache-related disability in migraine patients, especially given that the questionnaire is both simple and ease of use.

We developed a 77-item self-reporting questionnaire to assess the burden of migraine (BURMIG), including headache characteristics, migraine associated disability, comorbidities, management, and the consequences on the patients’ lives. We translated BURMIG into four languages (French, Portuguese, German and English) and tested it in 130 headache patients (20 pain clinic, 17 primary care and 93 general public) in Luxembourg. We performed a linguistic and a face-content validation and tested the questionnaire for its comprehensiveness, internal consistency and for its retest-reliability at an interval of 1 month (completion rates were 79.6 and 76.4%, for test and retest, respectively). Retest-reliability for the different parts of the questionnaire varied between 0.6 and 1.0 (Kappa coefficient), with an intracorrelation coefficient of 0.7–1.0. The internal consistency was between 0.74 and 0.91 (Cronbach’s alpha). The questionnaire BURMIG is suitable to evaluate the burden of migraine and can be used in English, German, French and Portuguese.

Electronic supplementary material

The online version of this article (doi:10.1007/s10194-008-0059-1) contains supplementary material, which is available to authorized users.

This prospective study investigated the effectiveness of a three-tier modularized out- and inpatient multidisciplinary integrated headache care program. N = 204 patients with frequent headaches (63 migraine, 11 tension-type headache, 59 migraine + tension-type headache, 68 medication-overuse headache and 3 with other primary headaches) were enrolled. Outcome measures at baseline, 6- and 12-month follow-ups included headache frequency, Migraine Disability Assessment (MIDAS), Hospital Anxiety and Depression Scale (HADS), standardized headache diary and a medication survey. Mean reduction in headache frequency was 5.5 ± 8.5 days/month, p < 0.001 at 6 months’ follow-up and 6.9 ± 8.3 days/month, p < 0.001 after 1 year. MIDAS decreased from 53.0 ± 60.8 to 37.0 ± 52.4 points, p < 0.001 after 6 months and 34.4 ± 53.2 points, p < 0.001 at 1 year. 44.0 % patients demonstrated at baseline an increased HAD-score for anxiety and 16.7 % of patients revealed a HAD-score indicating a depression. At the end of treatment statistically significant changes could be observed for anxiety (p < 0.001) and depression (p < 0.006). The intake frequency of attack-aborting medication decreased from 10.3 ± 7.3 days/month at admission to 4.7 ± 4.1 days/month, p < 0.001 after 6 months and reached 3.8 ± 3.5 days/month, p < 0.001 after 1 year. At baseline 37.9 % of patients had experience with non-pharmacological treatments and 87.0 % at 12-month follow-up. In conclusion, an integrated headache care program was successfully established. Positive health-related outcomes could be obtained with a multidisciplinary out- and inpatient headache treatment program.

Background

Research suggests that food intolerance may be a precipitating factor for migraine like headaches.

Aim

To evaluate the effectiveness of the ELISA (Enzyme Linked Immuno-Sorbent Assay) Test and subsequent dietary elimination advice for the prevention of migraine like headaches.

Design

Randomised controlled trial.

Setting

Community based volunteers in the UK.

Participants

Volunteers who met the inclusion criteria for migraine like headaches and had one or more food intolerance were included in the study. Participants received either a true diet (n = 84) or a sham diet (n = 83) sheet. Participants were advised to remove the intolerant foods from their diet for 12 weeks.

Main outcome measures

Number of headache days over a 12 week period (item A MIDAS questionnaire). Other measures includes the total MIDAS score and total HIT-6 score.

Results

The results indicated a small decrease in the number of migraine like headaches over 12 weeks, although this difference was not statistically significant (IRR 1.15 95% CI 0.94 to 1.41, p = 0.18). At the 4 week assessment, use of the ELISA test with subsequent diet elimination advice significantly reduced the number of migraine like headaches (IRR 1.23 95%CI 1.01 to 1.50, p = 0.04). The disability and impact on daily life of migraines were not significantly different between the true and sham diet groups.

Conclusions

Use of the ELISA test with subsequent diet elimination advice did not reduce the disability or impact on daily life of migraine like headaches or the number of migraine like headaches at 12 weeks but it did significantly reduce the number of migraine like headaches at 4 weeks.

Trial registration number

ISRCTN: ISRTCN89559672

The aim of this study was to translate the Fibromyalgia Impact Questionnaire (FIQ) into Korean and to evaluate its reliability and validity for use with Korean-speaking patients with fibromyalgia (FM). After translating the FIQ into Korean, we administered it to 55 patients with FM (28 patients filled out the questionnaire again 7 days later) together with a Korean version of the Health Assessment Questionnaire (HAQ) and the Symptom Checklist-90-Revision (SCL-90-R). The tender-point count (TPC) was calculated from tender points identified by thumb palpation. In addition to sociodemographic characteristics, the severity of relevant current clinical symptoms, e.g., pain intensity, fatigue, and morning stiffness, were assessed by 10-cm visual analog scales (VAS). The test-retest reliability was between 0.466 and 0.780 (total 0.778). Cronbach's alpha was 0.800 for FIQ1 (the first assessment) and 0.857 for FIQ2 (the second assessment), indicating acceptable levels of internal consistency for both assessments. Significant correlations were obtained between the FIQ items, the HAQ, the severity of clinical symptoms, and the subscales of the SCL-90-R. In conclusion, the Korean version of the FIQ is a reliable and valid instrument for measuring health status and physical functioning in Korean patients with FM.

Migraine is a highly prevalent and disabling disease that is substantially undiagnosed in primary care. Recently, the ID Migraine, a self–administered questionnaire, was shown to be a valid and reliable screener for migraine in primary care in the USA. To validate an Italian version of the ID Migraine, we planned a multicentric study, evaluating at least 220 patients affected by various form of headache. The responses to the questionnaire were compared with the diagnosis of headache made by a headache specialist blind to the result of the questionnaire. Sensitivity, specificity, and positive and negative predictive values for migraine were calculated. The statistical analysis on 140 patients now examined showed a very good performance of the ID Migraine with high sensitivity: 0.94 (95% CI: 0.89–0.95), specificity: 0.70 (95% CI: 0.54–0.86) and positive predictive value: 0.89 (0.82–0.95). If confirmed, these results would establish ID Migraine as a valid screening instrument for migraine in Italian headache patients and warrant further investigation in primary care to assess the validity of this ID screener in Italian population.

Background

Headache is the most frequent neurological symptom and the most common manifestation of pain in childhood. Estimates of the prevalence of headache in children and adolescents vary widely (depending on the setting, methodology, and diagnostic criteria applied) and the impact is not well understood.

Aim

To quantify the impact of headache in a school population.

Design of study

A questionnaire survey.

Setting

Exeter schools.

Method

A total of 1037 school children between the ages of 12 and 15 years were surveyed, of whom 49% were female. Main outcome measures were headache frequency, disease-specific impact using the Pediatric Migraine Disability Assessment Score (PedMIDAS), and generic quality of life impact using the Pediatric Quality of Life Inventory (PedsQL4).

Results

Twenty per cent of the study population had headache one or more times a week, with an average PedMIDAS score of over 12.1 (and an impact on over 12 days in a 3-month period). Ten per cent of the population had a PedMIDAS score of 16.8 and a PedsQL4 generic quality of life score of 70.1, indicating a poorer quality of life than that of children with asthma, diabetes, or cancer. An average of 0.6 days of school was lost in a 3-month period across all school children.

Conclusion

There is a significant impact of headache on the quality of life of children. This impact is both unrecognised and unmet. GPs have an important role in identification and management of this problem.

Objectives:

Research increasingly suggests that obesity is an exacerbating factor for migraine. However, it is less clear whether weight loss may help to alleviate migraine in obese individuals. We examined whether weight loss after bariatric surgery is associated with improvements in migraine headaches.

Methods:

In this prospective observational study, 24 patients who had migraine according to the ID-Migraine screener were assessed before and 6 months after bariatric surgery. At both time points, patients had their weight measured and reported on frequency of headache days, average headache pain severity, and headache-related disability over the past 90 days via the Migraine Disability Assessment questionnaire. Changes in headache measures and the relation of weight loss to these changes were assessed using paired-sample t tests and logistic regression, respectively.

Results:

Patients were mostly female (88%), middle-aged (mean age 39.3), and severely obese (mean body mass index 46.6) at baseline. Mean (±SD) number of headache days was reduced from 11.1 ± 10.3 preoperatively to 6.7 ± 8.2 postoperatively (p < 0.05), after a mean percent excess weight loss (%EWL) of 49.4%. The odds of experiencing a ≥50% reduction in headache days was related to greater %EWL, independent of surgery type (p < 0.05). Reductions in severity were also observed (p < 0.05) and the number of patients reporting moderate to severe disability decreased from 12 (50.0%) before surgery to 3 (12.5%) after surgery (p < 0.01).

Conclusions:

Severely obese migraineurs experience marked alleviation of headaches after significant weight reduction via bariatric surgery. Future studies are needed to determine whether more modest, behaviorally produced weight losses can effect similar migraine improvements.

Classification of evidence:

This study provides Class III evidence that bariatric surgery is associated with reduction of migraine headaches in severely obese individuals.

Aims and Objectives:

Translation of the Insomnia Severity Index from English to Hindi and Validation of the Hindi version.

Materials and Methods:

The translation process of the Insomnia Severity Index was initiated after obtaining due permission from the author of the original version of the same. Translation was carried out by using standard translation procedures, such as combined translation, decentering, and pretest method. The final version of the Insomnia Severity Index in Hindi was finally validated. A randomly selected sample size of 65 subjects was enrolled for the purpose of validation and testing the reliability of Hindi version of the Insomnia Severity Index. Insomnia was present in 45 subjects and they constituted the insomnia group. The rest 20 subjects did not have insomnia and were included in the control group. The Hindi version of the Insomnia Severity Index was applied to both the groups.

Results:

The total sample constituted of 50.8% males and 49.2% females. The mean age in the control group was 30.8±8.3 years and that in the insomnia group was 40.3±4 years (t=3.04; P=0.001). The translated version of the Insomnia Severity Index showed a reliability of 0.91 (Cronbach's α=0.91). This was not just simple translation, but many of the words were changed to adapt it for the local population.

Conclusion:

The Hindi version of the Insomnia Severity Index is a valid and reliable tool that can be administered for the assessment of severity of insomnia.

Objectives

To examine the feasibility of administering behavioral migraine management training by telephone (TAT) and the acceptability of TAT to adolescents with episodic migraine.

Methods

34 adolescents (M = 14 years) with migraine (M = 3.6 migraines/month; M = 29.2 hours duration) were randomly assigned to a two-month telephone administered behavioral migraine management program (TAT) or to a standard Triptan Treatment (TT). Outcome was assessed at three- and eight-month evaluations. Participants completed a daily migraine diary that yielded information about number, duration and severity of migraines and migraine-related disability, as well as the Migraine Specific Quality of Life Questionnaire - Adolescent. In addition, TAT participants evaluated key aspects of the TAT program using 5-point Likert-like rating scales. Lastly, the ability of adolescents to demonstrate specific headache management skills following TAT was assessed.

Results

All fifteen adolescents who entered TAT successfully demonstrated either full or partial mastery of two or more skills and nearly half demonstrated at least partial mastery of all four skills evaluated. Ninety three percent of the TAT participants reported having a positive relationship with their phone counselor. They also reported a preference for the telephone-based treatment over in-clinic visits and rated the manual and tapes as helpful. Treatment effects (in terms of percent improvement) ranged from consistently large across both evaluations for improvement in number of migraines (54% and 71%), disability equivalent hours (80% and 63%) and quality of life (44% and 48%), to moderate or variable for migraine duration (35% and 23%) and severity (30% and 34%). The TT group also showed clinically meaningful reductions in headache parameters and improvements in quality of life.

Conclusions

Completion rates for TAT were high; adolescents evaluated their experience with TAT positively and were able to exhibit key behavioral headache management skills following treatment. While clinically significant improvements in migraine and migraine-related disability/quality of life were observed with both TAT and treatment as usual (triptan therapy), the small study size and the absence of a control group do not permit conclusions about the effectiveness of either treatment. Nonetheless these results indicate TAT may be a promising treatment format for improving access to behavioral treatments for underserved adolescents and justifies further evaluation of TAT both alone and in combination with drug therapy.

Background

Although there is a considerably high prevalence of developmental disorders in Turkey there are not many assessment tools related to evaluating the impact of these children on their family. The aim of this study was to determine the validity and reliability of the Turkish version of the Impact on Family Scale (IPFAM), a health related quality of life measurement to be utilized in clinical trials, health care services, research and evaluation.

Methods

Caregivers of 85 children with developmental disabilities answered the questionnaire and 65 of them answered it twice with a one week interval. The reliability of the measurement was assessed by Cronbach's alpha coefficient, and with intraclass correlation coefficient (ICC) for test-retest reliability. Construct validity was assessed by calculating the correlation between total impact score of IPFAM, WeeFIM and the physiotherapists' evaluation via Visual Analogue Scale (VAS) to determine the child's disability.

Results

Test-retest reliability was found to be ICC = 0.953 for total impact, 0.843 for financial support, 0.940 for general impact, 0.871 for disruption of social relations and 0.787 for coping. Internal consistency was tested using Cronbach's alpha and was found to be 0.902 for total impact of IPFAM. For construct validity the correlation between total impact score of IPFAM and WeeFIM was r = -0,532 (p < 0.001) and the correlation between total impact score of IPFAM and the physiotherapist's evaluation was r = 0.519 (p < 0.001).

Conclusion

The Turkish version of IPFAM was found to be a reliable and valid instrument for assessing the impact of developmental disorders of the child on the family.

Objective

The Childhood Trauma Questionnaire (CTQ) is perhaps the most widely used and well-studied retrospective measure of childhood abuse or neglect. This study tested the initial reliability and validity of a Korean translation of the Childhood Trauma Questionnaire (CTQ-K) among non-psychotic psychiatric outpatients.

Methods

The CTQ-K was administered to a total of 163 non-psychotic psychiatric outpatients at a university-affiliated training hospital. Internal consistency, four-week test-retest reliability, and validity were calculated. A portion of the participants (n=65) also completed the Trauma Assessment Questionnaire (TAQ), the Impact of Events Scale-Revised, and the Dissociative Experiences Scale-Taxon.

Results

Four-week test-retest reliability was high (r=0.87) and internal consistency was good (Cronbach's α=0.88). Each type of childhood trauma was significantly correlated with the corresponding subscale of the TAQ, thus confirming its concurrent validity. In addition, the CTQ-K total score was positively related to post-traumatic symptoms and pathological dissociation, demonstrating the convergent validity of the scale. The CTQ-K was also negatively correlated with the competence and safety subscale of the TAQ, confirming discriminant validity. Additionally, we confirmed the factorial validity by identifying a five-factor structure that explained 64% of the total variance.

Conclusion

Our study indicates that the CTQ-K is a measure of psychometric soundness that can be used to assess childhood abuse or neglect in Korean patients. It also supports the cross-cultural equivalence of the scale.

Earlier studies conducted among migraineurs have shown an association between migraine and restless legs syndrome (RLS). We chose RLS patients and looked for migraine to exclude sample bias.

Materials and Methods:

99 consecutive subjects of idiopathic RLS were recruited from the sleep clinic during four months period. Physician diagnosis of headache and depressive disorder was made with the help of ICHD-2 and DSM-IV-TR criteria, respectively. Sleep history was gathered. Severity of RLS and insomnia was measured using IRLS (Hindi version) and insomnia severity index Hindi version, respectively. Chi-square test, one way ANOVA and t-test were applied to find out the significance.

Results:

Primary headache was seen in 51.5% cases of RLS. Migraine was reported by 44.4% subjects and other types of ‘primary headaches’ were reported by 7.1% subjects. Subjects were divided into- RLS; RLS with migraine and RLS with other headache. Females outnumbered in migraine subgroup (χ2=16.46, P<0.001). Prevalence of depression (χ2=3.12, P=0.21) and family history of RLS (χ2=2.65, P=0.26) were not different among groups. Severity of RLS (P=0.22) or insomnia (P=0.43) were also similar.

Conclusion:

Migraine is frequently found in RLS patients in clinic based samples. Females with RLS are prone to develop migraine. Depression and severity of RLS or insomnia do not affect development of headache.

Prospective single cohort study. To evaluate the NDI by comparison with the SF36 health Survey Questionnaire. The NDI is a simple ten-item questionnaire used to assess patients with neck pain. The SF36 measures functional ability, well being and the overall health of patients. It is used as a gold standard in health economics to assess the health utility, gain and economic impact of medical interventions. One hundred and sixty patients with neck pain attending the spinal clinic completed self-assessment questionnaires. A second questionnaire was completed in 34 patients after a period of 1–2 weeks. The internal consistency of the NDI and SF36 was calculated using Cronbach’s alpha. The test–retest reliability was assessed using the Bland and Altman method. The concurrent validity of the NDI with respect to the SF-36 was assessed using Pearson correlations. Both questionnaires showed robust internal consistency: Cronbach’s alpha for the NDI scale was acceptable (0.864, 95% confidence limits 0.825–0.894) though slightly smaller than that of the SF36. The correlations between each item of the NDI scores and the total NDI score ranged from 0.447 to 0.659, (all with P < 0.001). The test–retest reliability of the NDI was high (intra-class correlation 0.93, 95% confidence limits 0.86–0.97) and comparable with the best values found for SF36. The correlations between NDI and SF36 domains ranged from −0.45 to −0.74 (all with P < 0.001). We have shown that the NDI has good reliability and validity and that it compares well with the SF36 in the spinal surgery out patient setting.

In order to satisfy the need of a tool for assessing the treatment of patients with degenerative lumbar spinal stenosis, an evaluation was made of the reliability, construct validity, and responsiveness of the Norwegian version of Spinal Stenosis Measure (SSM, original by Stucki)). This study was a part of a prospective, cohort study. About 75 patients referred for surgery for spinal stenosis participated in the study. A subsample of 30 patients answered the questionnaire twice, test and retest, with at least one week in between. The SSM was translated according to the Guillemin criteria. Reliability was assessed by Bland and Altman’s repeatability, intraclass correlation coefficient (ICC) and the coefficient of variance (CV). Internal consistency was assessed by Cronbach’s alpha. Construct validity was analysed by correlation analyses. Responsiveness was calculated by the effect size. The reliability between test and retest scores was good for all three subscales of SSM as the ICC-values were above 0.9 and the CVs were below 15%. Cronbach’s alpha was above 0.8. The correlation analyses showed high correlation between scales that assessed the same construct, and low to moderate correlation between scales that assessed different constructs. Large effect sizes were found in all the SSM subscales with effect sizes ≥1.2.The Norwegian SSM version has added a highly useful tool for assessing the disease specific status and outcome after treatment in patients who suffer from degenerative lumbar spinal stenosis.

Headache is the most frequent neurological symptom and common manifestation of pain in children. The needs of this group are poorly understood. The aim of this study is to quantify the extent of unmet need in a primary care paediatric population. A patient questionnaire survey of 2,425 children between the ages of 8 and 17 and an uncontrolled intervention study was undertaken in a large general practice in England. Headache impact was measured before and 4 months after a headache clinic intervention using the paediatric migraine disability assessment score. A total number of 74 (3%) children accepted an invitation for a headache assessment. However, only 49 (2%) attended for consultation of whom 84% were judged to have migraine. A total number of 43 (58%) had been seen before for a headache by their general practitioner. The median impact score was 17 days headache impact in a 3-month period. An intervention by a general practitioner with an interest in headache significantly reduced the headache impact score. There is a significant need amongst children with headache that can be addressed by interventions well within the capacity of general practitioners. Further studies are needed to explore why so few children with headache present to primary care and when they do, why their needs are not adequately addressed.

Background

There is a need for outcome measurement instruments for evaluation of disability after trauma. The Patient-Rated Wrist Evaluation (PRWE) is a self-administered region-specific outcome measuring instrument developed for use in evaluating disability and pain of the wrist. The aim of this study is to translate and to cross-culturally adapt the PRWE for use in a Swedish patient population. Moreover, we aim at investigating the PRWE in terms of validity, reliability and responsiveness.

Methods

We performed a translation and cross-cultural adaptation of the PRWE to Swedish (PRWE-Swe), utilising the process recommended by the American Association of Orthopedic Surgeons. A total of 124 patients with an injury to the wrist were included in the study. They filled in the PRWE and the DASH questionnaires at two separate occasions.

Results

Reliability of the PRWE in terms of internal consistency (Cronbach's alpha 0.97) and test-retest stability (intraclass correlation coefficient 0.93) were excellent. Face validity and content validity were judged as good. Criterion validity assessed as the correlation between the PRWE and the DASH was also good (Spearman's rho = 0.9). Responsiveness measured by the standardized response mean (SRM) was good with an SRMPRWE of 1.29.

Conclusion

This Swedish version of the PRWE is a short and easily understood self-administered questionnaire with good validity, reliability, and responsiveness. Our results confirm that the PRWE is a valuable tool in evaluating the results after treatment of a wrist injury.

Background:

Migraine is a common, disabling headache disorder that leads to lost quality of life and productivity. We investigated whether a proactive approach to patients with migraine, including an educational intervention for general practitioners, led to a decrease in headache and associated costs.

Methods:

We conducted a pragmatic randomized controlled trial. Participants were randomized to one of two groups: practices receiving the intervention and control practices. Participants were prescribed two or more doses of triptan per month. General practitioners in the intervention group received training on treating migraine and invited participating patients for a consultation and evaluation of the therapy they were receiving. Physicians in the control group continued with usual care. Our primary outcome was patients’ scores on the Headache Impact Test (HIT-6) at six months. We considered a reduction in score of 2.3 points to be clinically relevant. We used the Kessler Psychological Distress Scale (K10) questionnaire to determine if such distress was a possible effect modifier. We also examined the interventions’ cost-effectiveness.

Results:

We enrolled 490 patients in the trial (233 to the intervention group and 257 to the control group). Of the 233 patients in the intervention group, 192 (82.4%) attended the consultation to evaluate the treatment of their migraines. Of these patients, 43 (22.3%) started prophylaxis. The difference in change in score on the HIT-6 between the intervention and control groups was 0.81 (p = 0.07, calculated from modelling using generalized estimating equations). For patients with low levels of psychological distress (baseline score on the K10 ≤ 20) this change was −1.51 (p = 0.008), compared with a change of 0.16 (p = 0.494) for patients with greater psychological distress. For patients who were not using prophylaxis at baseline and had two or more migraines per month, the mean HIT-6 score improved by 1.37 points compared with controls (p = 0.04). We did not find the intervention to be cost-effective.

Interpretation:

An educational intervention for general practitioners and a proactive approach to patients with migraine did not result in a clinically relevant improvement of symptoms. Psychological distress was an important confounder of success. (Current Controlled Trials registration no. ISRCTN72421511.)

Background

Many migraineurs who seek care in headache clinics are refractory to treatment, despite advances in headache therapies. Epidemiology is poorly characterized, because diagnostic criteria for refractory migraine were not available until recently. We aimed to determine the frequency of refractory migraine in patients attended in the Headache Unit in a tertiary care center, according to recently proposed criteria.

Methods

The study population consisted of a consecutive sample of 370 patients (60.8% females) with a mean age of 43 years (range 14-86) evaluated for the first time in our headache unit over a one-year period (between October 2008 and October 2009). We recorded information on clinical features, previous treatments, Migraine Disability Assessment Score (MIDAS), and final diagnosis.

Results

Overall migraine and tension-type headache were found in 46.4% and 20.5% of patients, respectively. Refractory migraine was found in 5.1% of patients. In refractory migraineurs, the mean MIDAS score was 96, and 36.8% were medication-overusers.

Conclusions

Refractory migraine is a relatively common and very disabling condition between the patients attended in a headache unit. The proposed operational criteria may be useful in identifying those patients who require care in headache units, the selection of candidates for combinations of prophylactic drugs or invasive treatments such as neurostimulation, but also to facilitate clinical studies in this patient group.

Background and purpose The WOSI score questionnaire is a tool designed for self-assessment of shoulder function for patients with instability problems. We made a translation into Swedish and retested the score by analyzing the psychometric properties validity, reliability, and responsiveness.

Patients and methods 3 patient materials were used for the assessment: (A) a follow-up on a group of 32 patients more than 8 years after having primary posttraumatic shoulder dislocation. Evaluation of Pearson’s correlation coefficient between WOSI and Rowe score and for test-retest reliability was made; (B) 22 patients, treated with a surgical stabilization of the shoulder at our department, were evaluated with Pearson’s correlation coefficient between WOSI and EQ-5D, and between WOSI and a VAS-scale of general shoulder function. Also, Cronbach’s alpha, effect size, and floor, and ceiling effects were analyzed; (C) 45 students with healthy shoulders (reference group) had their WOSI score determined.

Results The construct validity (Pearson’s correlation coefficient) was adequate (0.59) between the WOSI score and the Rowe score. The agreement with an ICC value (test-retest) for the WOSI score was excellent (0.94). Cronbach’s alpha (internal consistency) was satisfactory, with 0.89 preoperatively and 0.95 postoperatively. All 22 patients in group B reported improvement in the WOSI score (mean 29%). Responsiveness was excellent, with an effect size of 1.67 for the WOSI score. There were no floor or ceiling effects for the Swedish WOSI score. The mean WOSI score from group C with 45 normal healthy shoulders was 96%, with no floor but high ceiling effects.

Interpretation WOSI score does not require an examination of the patient and can be administered by mail. The high ICC and sensitivity makes it able to monitor an individual patient’s progress. At this retest, the WOSI score has good validity, a high degree of reliability, and a high degree of responsiveness, all at the same level as in the original publication. We recommend the WOSI when evaluating patients with instability problems.

To evaluate the influence of psychometric variables on the “repeater” phenomenon in an emergency department, 15 “repeaters” and 27 outpatient migraineurs were recruited. All patients were submitted to the Beck Depression Inventory (BDI), State and Trait Anxiety Inventory, Toronto Alexithymia Scale–20 (TAS–20), Tridimensional Personality Questionnaire and Migraine DIsability Assessment Scale (MIDAS). The “repeater” group showed higher MIDAS total scores (p=0.02) and higher scores in TAS–20 (p=0.02) than the outpatients. A higher frequency of alexithymic trait (p=0.02) and higher BDI scores (p=0.07) have also been observed in the “repeater” group than the outpatients. Alexithymia and depressive mood associated with high disability may be a specific psychosocial pattern of “repeater” migraineurs. The psychometric evaluation of this population may be important to explain the “repeaters” phenomenon.

Background: Cross cultural validity is of vital importance for international comparisons.

Objective: To investigate the validity of international Dutch-English comparisons when using the Dutch translation of the Western Ontario and McMaster Universities osteoarthritis index (WOMAC).

Patients and Methods: The dimensionality, reliability, construct validity, and cross cultural equivalence of the Dutch WOMAC in Dutch and Canadian patients waiting for primary total hip arthroplasty was investigated. Unidimensionality and cross cultural equivalence was quantified by principal component and Rasch analysis. Intratest reliability was quantified with Cronbach's α, and test-retest reliability with the intraclass correlation coefficient. Construct validity was quantified by correlating sum scores of the Dutch WOMAC, Arthritis Impact Measurement Scales (Dutch AIMS2), Health Assessment Questionnaire (Dutch HAQ), and Harris Hip Score (Dutch HHS).

Results: The WOMAC was completed by 180 Dutch and 244 English speaking Canadian patients. Unidimensionality of the Dutch WOMAC was confirmed by principal component and Rasch analysis (good fit for 20/22 items). The intratest reliability of the Dutch WOMAC for pain and physical functioning was 0.88 and 0.96, whereas the test-retest reliability was 0.77 and 0.92, respectively. Dutch WOMAC pain sum score correlated 0.69 with Dutch HAQ pain, and 0.39 with Dutch HHS pain. Dutch WOMAC physical functioning sum score correlated 0.46 with Dutch AIMS2 mobility, 0.62 with Dutch AIMS2 walking and bending, 0.67 with Dutch HAQ disability, and 0.49 with Dutch HHS function. Differential item functioning (DIF) was shown for 6/22 Dutch items.

Conclusions: The Dutch WOMAC permits valid international Dutch-English comparisons after correction for DIF.

Background

The Foot and Ankle Ability Measure (FAAM) is a self reported questionnaire for patients with foot and ankle disorders available in English, German, and Persian. This study plans to translate the FAAM from English to French (FAAM-F) and assess the validity and reliability of this new version.

Methods

The FAAM-F Activities of Daily Living (ADL) and sports subscales were completed by 105 French-speaking patients (average age 50.5 years) presenting various chronic foot and ankle disorders. Convergent and divergent validity was assessed by Pearson's correlation coefficients between the FAAM-F subscales and the SF-36 scales: Physical Functioning (PF), Physical Component Summary (PCS), Mental Health (MH) and Mental Component Summary (MCS). Internal consistency was calculated by Cronbach's Alpha (CA). To assess test re-test reliability, 22 patients filled out the questionnaire a second time to estimate minimal detectable changes (MDC) and intraclass correlation coefficients (ICC).

Results

Correlations for FAAM-F ADL subscale were 0.85 with PF, 0.81 with PCS, 0.26 with MH, 0.37 with MCS. Correlations for FAAM-F Sports subscale were 0.72 with PF, 0.72 with PCS, 0.21 with MH, 0.29 with MCS. CA estimates were 0.97 for both subscales. Respectively for the ADL and Sports subscales, ICC were 0.97 and 0.94, errors for a single measure were 8 and 10 points at 95% confidence and the MDC values at 95% confidence were 7 and 18 points.

Conclusion

The FAAM-F is valid and reliable for the self-assessment of physical function in French-speaking patients with a wide range of chronic foot and ankle disorders.