OBJECTIVE To describe translation methods, to outline current recommendations for translation and to give an overview of translation procedures used in headache. BACKGROUND In health-care research, particularly in the domain of health-related quality of life, an increasing number of questionnaires are translated for cross- cultural comparison. A number of headache-related questionnaires have also been translated. To ensure true cross-cultural comparison, it is important to use rigorous translation methods to ensure a high quality translated version of the instruments. METHODS Literature relevant to cross-cultural translations was reviewed, as well as literature concerning translation of headache-related instruments. CONCLUSION More information on the translation process for headache-related instruments is essential to carry out high quality cross-cultural research. Recommendation are given to encourage good translation practices.

Intraoral splints are effective in migraine prevention. In this review, changes in the quality of life of migraineurs treated with a palatal nonoccluding splint were measured. Using the Migraine Specific Quality of Life Instrument (Version 2.1), it was found that the palatal nonoccluding splint significantly improved the quality of life of migraineurs. The role of the craniomandibular muscles in the pathophysiology of migraine is also discussed.

We conducted a prospective study among 166 multiple sclerosis (MS) patients (103 from an university hospital, 63 from a MS rehabilitation center) to assess the properties of the French version of the Multiple Sclerosis Quality Of Life - 54 items (MS QOL-54) which combines the MOS SF36 together with MS specific items. The SF-36 had been translated into French through the IQOLA project. We translated and adapted the MS specific items with the help of three different teams. The translation into French has an addition of five items, because we kept the MS specific items of an earlier unpublished form. Acceptability is excellent with a response rate over 90p.100. Test-retest reliability is good except for the "role limitation-emotional" scale of the SF-36. Construct validity, based on factor analysis, shows no change in the SF-36 internal consistency and the specific items provided their own information. External validity, tested against both medical (Expanded Disability Status Scale, Kurtzke scale, Mini-Mental-State and disease stage) and rehabilitation (Functional Independence Measure) parameters is excellent. The French MS QOL questionnaire contains 59 items including both the SF-36 and the MS QOL-54 items. This will permit international comparisons of MS patients' care and therapy.

INTRODUCTION: Cognitive disorders may bias perception of quality-of-life in patients with multiple sclerosis (MS). METHODS: Neuropsychological tests (WAIS-vocabulary, Gröber and Buschke, Stroop, WCST, WAIS-similitude, fluency, Hamilton's depression scale) along with a French health-related quality of life self questionnaire for MS patients (the SEP59) were performed by 117 MS patients with a minor cognitive impairment (Mini Mental State over 24) in order to explore the links between quality of life perception and cognitive functioning. RESULTS: Main Component Analysis and correlation analysis showed that cognitive impairment produced an overrating of the self perception of quality of life. Threshold analysis, splitting patients between the most and the less cognitively impaired, confirmed this relationship. CONCLUSION: The level of cognitive functioning must be considered with caution when analyzing health-related quality of MS patients.

The insensitivity of the clinical scales usually performed in MS patients led to measure the quality of life (QoL). QoL includes several important domains of health which are regarded by patients as being more important determinants of their overall health states. Some aspects of QoL of MS patients (early collapse in the disease, impact of interferons therapy) suggested that its measurement is relevant in assessing the effect of treatment and progression of the disease.

Multiple sclerosis is responsible for impairment and disability, which play a major role in the personal burden of the disease. Health-related quality of life (HRQoL) has been intensively studied in this medical condition, more intensively than in other chronic neurological disorders, perhaps because of the limitations of the conventional disability instruments, which seem less sensitive to change. Moreover, HRQoL measurements can summarize all sources of patient satisfaction and dissatisfaction. Instead of relying on motor limitations, many psychological, social, and neuropsychological factors, such as cognitive impairment and fatigue, are predictors of a reduced quality of life, even in the early stages, more than conventional radiological MRI. The analysis of self-administered HRQoL questionnaires, generic or mixed (specific and generic), can help clinicians advance toward the best therapeutic approach for the patient.

The malnutrition common among patients with ALS can be attributed in some cases to increased resting energy expenditure (REE). However, the origins and evolution of this hypermetabolism have yet to be fully elucidated. The aim of the present study was to monitor REE over time in patients with ALS and to identify factors that may explain any variation observed. ALS patients underwent nutritional, neurological and respiratory assessment every 6 months for 2 years (or until they died or became physically incapable of being examined). Sixty-one patients were studied. At inclusion, 47.5% exhibited hypermetabolism, with a mean measured REE (mREE) 19.7 +/- 6.4% higher than the mean calculated REE (cREE)(P < 0.0001). The hypermetabolism persisted when mREE was normalized for fat free mass (FFM): 35.1 +/- 4.2 versus 32.3 +/- 4.7 kcal/kg day(-1)(P = 0.02) in hypermetabolic and normometabolic patients, respectively. In univariate analysis, mREE was negatively correlated with age and positively correlated with BMI, FFM, energy and protein intakes, and albumin level. No correlation was found with neurological scores, disease characteristics, respiratory function and survival. Multivariate analysis revealed no significant factors. Only 10 of 45 patients in whom REE was measured at least twice changed their metabolic status. Neither mREE nor mREE/cREE varied significantly over time, despite deteriorating neurological, nutritional and respiratory parameters (P < 0.0001), and an increase in mREE/FFM (P = 0.01). This study confirms that about 50% of ALS patients are hypermetabolic, and 80% show no change in metabolic status over time. Thus, metabolic status (a clinically useful indicator of the need for nutritional support) can be determined early in the evolution of the disease. The origin of hypermetabolism in this context remains unknown, but growing evidence points to mitochondria as having an important role.

To assess the efficiency of melanoma screening and prevention campaigns in the Auvergne region (France), cases of melanoma have been recorded since 1st June 1998. The epidemiological follow-up of melanoma was carried out using two sentinel networks; one involving the pathologists, and the other, the dermatologists of the region. Incidence was calculated using the capture-recapture method, by cross-matching the data supplied by both dermatologists and pathologists. Between June 1st 1998 and December 31st 2000, 363 cases of melanoma were recorded. The crude incidence rate of melanoma per 100,000 person-years was 17.1 for all melanomas and 14.6 for invasive melanomas. These rates of incidence were higher than the estimated national rate of France, and were close to incidences found in countries of Northern Europe. This might be explained by an increase in screening for melanoma, by more precise estimation of the incidence due to the capture-recapture method, or by geographic factors (mountainous area). An answer may be provided by following the variation in time of incidence and thickness of melanomas; the increase in the number of thin (low Breslow index) melanomas corresponding with increased screening.

OBJECTIVE: To evaluate the quality of life of patients treated in a pain center. METHOD: Sixty eight patients were assessed during their first consultation, then 6, 12 and 18 months later, using a quality of life questionnaire "SQVP or Subjective Quality of Life Profile" validated in French populations and a panel of questionnaires for the monitoring of chronic pain, recommended by the ANAES (French Agency for Health Assessment). RESULTS: Results showed that: the patients' quality of life was clearly deteriorated (lowest quality in the data base--14,000 patients--with regard to the SQVP); the profile obtained (severe handicap) suggests that the lumbagos are part of a psychiatric context; the patients' quality of life clearly improves after 6 months' treatment, but the pain only stabilizes later.

BACKGROUND: Amyotrophic lateral sclerosis (ALS) is a severe disease characterized by neurogenic amyotrophy and degeneration of upper and lower motor neurons. Although ALS patients usually experience reductions in fat-free mass (FFM), hypermetabolism via an undetermined source has also been reported. OBJECTIVE: The objective was to clarify the metabolic level of ALS patients. DESIGN: We measured the resting energy expenditure (REE) of 62 patients (32 men and 30 women) with ALS and investigated the factors correlated with metabolic level. Nutritional evaluation included bioelectrical impedance analysis, indirect calorimetry, and calculation of the body mass index. Neurologic assessment included an evaluation of peripheral and central neurologic deficit. Forced vital capacity was measured and smoking status was noted. A complete blood cell count was made and thyroid hormone and C-reactive protein concentrations were measured. RESULTS: Patients were hypermetabolic, by an average of approximately 10% more than in a reference healthy population. FFM, age, and the neutrophil count were significantly associated with REE. The only variable that contributed to the prediction of REE, REE/Z100 kHz (bioimpedance at 100 kHz), REE adjusted for FFM, or the ratio of measured REE to calculated REE was the neutrophil count, which explained only a small percentage of variance in the multiple regression analysis. Hypermetabolism was not associated with a reduction in respiratory function, tobacco use, hyperthyroidism, spasticity and fasciculation intensities, or infection. CONCLUSIONS: Our study corroborates the surprising finding that ALS patients are hypermetabolic. FFM, age, sex, manual muscular testing, the modified Norris limb score, weight, and an increase in circulating neutrophil counts correlated with the hypermetabolic state. Other factors may play a role in pathophysiologic processes that involve mitochondrial energy production or even sympathoadrenergic activation.

PURPOSE To develop and test the psychometric properties of a parent-reported questionnaire measuring participation of preschool children (Children Participation Questionnaire; CPQ) aged 4-6 years in their everyday activities. METHODS Reliability was tested by Cronbach's alpha and by test-retest. Construct validity was computed by known group differences analysis. Convergent and divergent validities were calculated by correlation with the Vineland Adaptive Behaviour Scale (VABS). Two hundred thirty-one children with mild to moderate developmental disabilities (mean age 5.16 +/- 0.66 years old) were compared to 249 children without disability (mean age 5.13 +/- 0.72 years old). RESULTS The CPQ has good internal reliability. Cronbach's alpha for the participation measures ranged between 0.79 and 0.90, indicating good homogeneity. The temporal stability of the CPQ was supported with intra-class correlations ranging from 0.71 to 1.00. Significant differences were found between children with and without disabilities in all the CPQ measures. The CPQ could also differentiate between age groups and groups of varying socio-economic status. Convergent and divergent validity were supported. CONCLUSIONS The CPQ has demonstrated good psychometric properties and can be used as a reliable and valid measure to assess children's participation at the age of 4-6 years.

BACKGROUND Sickle cell disease is the commonest genetic disorder in Jamaica and most likely exerts numerous effects on quality of life (QOL) of those afflicted with it. The WHOQOL-Bref, which is a commonly utilized generic measure of quality of life, has never previously been utilized in this population. We have sought to study its utility in this disease population. METHODS 491 patients with sickle cell disease were administered the questionnaire including demographics, WHOQOL-Bref, Short Form-36 (SF-36), Flanagan's quality of life scale (QOLS) and measures of disease severity at their routine health maintenance visits to the sickle cell unit. Internal consistency reliabilities, construct validity and "known groups" validity of the WHOQOL-Bref, and its domains, were examined; and then compared to those of the other instruments. RESULTS All three instruments had good internal consistency, ranging from 0.70 to 0.93 for the WHOQOL-Bref (except the 'social relationships' domain), 0.86-0.93 for the SF-36 and 0.88 for the QOLS. None of the instruments showed any marked floor or ceiling effects except the SF-36 'physical health' and 'role limitations' domains. The WHOQOL-Bref scale also had moderate concurrent validity and showed strong "known groups" validity. CONCLUSION This study has shown good psychometric properties of the WHOQOL-Bref instrument in determining QOL of those with sickle cell disease. Its utility in this regard is comparable to that of the SF-36 and QOLS.

BACKGROUND: Atrial fibrillation (AF) is the most common sustained arrhythmia in clinical practice, and has major impact on health-related quality of life, thus, there is a need for a specific instrument to assess AF symptoms and quality of life. METHODS: We developed and validated a specific questionnaire for quality of life in AF patients (QLAF) based on clinical manifestations (palpitation, breathlessness, dizziness and chest pain), and the usual treatments (medication, cardioversion and ablation). For validation, the new questionnaire was compared with the generic SF-36 questionnaire. Reproducibility was tested using 40 questionnaires administered by two different observers at distinct times and places. Responsiveness was evaluated based on variation of the QLAF score over time. RESULTS: There were a total of 462 questionnaires (231 SF-36 and 231 QLAF) administered at baseline, 3, 6, 9 and 12 months. Construct validity was demonstrated by the negative correlation between QLAF and SF-36 scores that was observed over the follow-up period. Analysis of internal consistency for reproducibility showed excellent Cronbach's alpha coefficients (inter- and intraobserver coefficients of 0.98 and 0.96, respectively). QLAF was responsive as indicated by significant differences in mean domain scores from the beginning to the end of follow-up. It took much less time to administer the QLAF than the SF-36 (3:08+/-0:33 min vs. 9:25+/-1:14 min, p<0.001). CONCLUSION: The QLAF questionnaire is easy to understand and can be administered rapidly in the outpatient setting. Furthermore, the QLAF score is valid and reproducible and responsive to a change in clinical status.

OBJECTIVES: The aim of this study was to develop a Spanish version of the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) and to test its acceptability, reliability, validity, and sensitivity to change. METHODS: Forward and back translation by bilingual translators followed by pilot testing in patients with urticaria was used to adapt the questionnaire. The Spanish version of the CU-Q2oL was self-administered alongside the Skindex-29 in an observational, longitudinal, multicenter study. Feasibility was assessed by analyzing missing responses and ceiling and floor effects. Reliability was tested by examining internal consistency (Cronbach alpha). Construct validity was analyzed by examining convergent and discriminant validity with the Skindex-29 and by evaluating the ability of the CU-Q2oL to discriminate between patients according to a clinical classification of severity. Sensitivity to change was analyzed in a subgroup of patients who completed a second visit 4 weeks after baseline. RESULTS: A total of 695 patients were included in the analysis. Mean (SD) age was 42.4 (15.0) years and 62.1% of the sample was female. All of the items on the CU-Q2oL were answered by 91.9% of the sample. Over 15% of patients scored at the floor (best possible health) on 5 of the 6 dimensions. Cronbach alpha coefficients were > 0.80 for all dimensions of the CU-Q2oL, and 0.86 for the overall score. Construct validity was supported by correlations between the CU-Q2oL and the Skindex-29, which generally fulfilled hypotheses, and by the questionnaire's ability to discriminate between groups with different severities of urticaria.The questionnaire was sensitive to change, with an effect size of 1.0 for the overall score in patients reporting an improvement on the health transition scale. CONCLUSIONS: The Spanish version of the CU-Q2oL has shown satisfactory reliability, validity, and sensitivity to change. It is suitable for use as an outcome measure for chronic urticaria patients in clinical and research settings.

Health-related quality of life measurements are gaining more importance in the study and clinical practiceof multiple sclerosis. The aim of our study was the adaptation of the Multiple Sclerosis Quality ofLife Instrument (MSQOL-54) in Hungarian. The study was carried out at the Department of Neurology,University of Szeged and two other multiple sclerosis centers. The Hungarian translation of the questionnairewas given to patients at the outpatient units of the neurology departments. The EDSS scoreof the patients were determined and data concerning the onset and the clinical form of the diseasewas collected. Altogether 438 patients filled out the questionnaire. We enrolled patients with all clinicalforms of the disease. Cronbach's alpha coefficients were over 0.8 in case of all scales except 'Rolelimitations- emotional'(0.794), indicating a good internal consistency reliability for group comparisons.The instrument was able to distinguish between known clinical group differences. TheHungarian version of the MSQOL-54 instrument shows good psychometric properties similar to theoriginal questionnaire.

BACKGROUND Despite advances in therapy, the prevalence of migraine has remained constant over the past 17 years. The current diagnostic procedure for migraine does not take into account the entire cycle of migraine, which includes both the pain of the acute attack and the worry between attacks. OBJECTIVES This review discusses the effects of migraine on health-related quality of life. The focus is on the impact of migraine between attacks and more successful clinical management of the complete cycle of migraine in both the neurology and primary care settings. METHODS A search of MEDLINE (January 1997-January 2007) was conducted to determine the impact of migraine on quality of life and the need for and use of migraine preventive treatment. The search terms were migraine prevention, migraine prophylaxis, bead-ache and quality of life, migraine disability, and head-ache disability. The inclusion of specific studies was based on subjective, comparative evaluation and standard levels of evidence. Older publications were included to provide a historical perspective. RESULTS Worry in expectation of the next migraine attack can have negative effects on the family and social lives and work productivity of patients with migraine. The benefits of preventive pharmacotherapy for migraine may be measured over time in terms of changes in the frequency of acute attacks, impact of acute treatment on headache recurrence within the next 24 hours, and reduction in overall functional impairment. Optimizing the acute treatment outcome and reducing the frequency of episodes may help alleviate the cycle of migraine. The clinical assessment of migraine should include multiple dimensions. Several questionnaires, such as the Migraine Disability Assessment and the 6-item Headache Impact Test, have been developed to help clinicians assess the dimensions of migraine. These questionnaires should be used in conjunction with open communication techniques that elicit any underlying worry associated with migraines. Preventive therapies that have been approved by the US Food and Drug Administration include the neurostabilizers divalproex sodium and topiramate, and the beta-blockers timolol and propranolol. Despite not being approved for this indication, the antidepressant amitriptyline has shown levels of evidence of efficacy in preventing migraine in controlled trials similar to those for the approved medications. CONCLUSION The assessment of whether patients with migraine may benefit from preventive therapy should include the use of open communication techniques to uncover possible impairment between attacks.

To develop and validate a disease-specific quality of life (QoL) measure, based on the conceptual model of the SKINDEX-29 for patients with a chronic venous leg ulcer (VLU), in-depth interviews, and focus groups of patients (n=36) with VLU were used to generate VLU-specific items. These items were added to selected SKINDEX-29 items that were adapted for use in VLU. Further samples of VLU patients were used for item reduction (n=124) and to assess the psychometric properties of the new tool (n=120). The final VLU-QoL contained 34 items: 17 items adapted from the SKINDEX-29 and 17 VLU-specific items. Factor analysis of the items confirmed the existence of three hypothesized domains: Activities (12 items), Psychological (12 items), and Symptom Distress (10 items). Reliability in terms of internal consistency and test-retest reliability was found to be good. The measure was also found to be valid and responsive to clinical change. The VLU-QoL has good psychometric properties. The instrument's sensitivity to differences in clinical outcome and responsiveness to change in clinical parameters makes it a useful tool to assess the outcomes of treatment from the patients' perspective.

The purpose of the study was to assess the reliability of the specific multiple sclerosis quality of life (MSQOL-54) instrument, which contains 54 items measuring quality of life, among Finnish multiple sclerosis (MS) patients. Nursing professionals evaluated the clarity and comprehensibility of the translated instrument, after which it was pilot-tested. The data were collected through a questionnaire survey in the spring 2004. Persons diagnosed with MS in 1999-2001 filled in the questionnaire (n = 100). The response percentage was 81%. The structural validity of the MSQOL-54 instrument was evaluated with factor analysis and the generic 15D quality of life instrument. The internal consistency of the instrument was measured with Cronbach's alpha, correlations and item analysis. According to the results, the structural validity of MSQOL-54 was good, and factor analysis yielded a clear-cut factorial model. More than half of the correlations between the comparable items of the 15D and MSQOL-54 instruments were moderate or better. The internal consistency of MSQOL-54 can hence be considered quite good: Cronbach's alpha coefficients calculated for the factors and their items ranged within 0.33-0.89. The alpha coefficient calculated for the whole instrument was 0.84. The internal consistency of MSQOL-54 was further confirmed by the results of an item analysis, which showed the correlation coefficients between the items of the different dimensions to be good (0.31-0.81). On the basis of the test results, the MSQOL-54 instrument is fairly reliable and suitable for assessing the health-related quality of life of MS patients. The reliability of MSQOL-54 should be evaluated further by a longitudinal study design in the future.

BACKGROUND: Up to now, only an English version of the Chronic Pain Acceptance Questionnaire (CPAQ) has been available for measuring the acceptance of chronic pain. This paper presents and analyzes a German adaptation of this instrument.METHODS: The German scale was tested on 150 patients at the DRK Pain Center in Mainz. Validity was assessed by means of various indicators of pain and psychosocial impairment. In a subgroup (n=50) the association with the heat pain threshold was determined.RESULTS: The factor structure of the German CPAQ scale is largely concordant with the theoretical model. The internal consistency of the total and subscales is 0.84-0.87 (Cronbach's alpha). The factors are closely related to indicators of psychosocial functioning. Associations with the affective dimension of pain are moderate and with the sensory dimension low. No association is found with heat pain thresholds (thermal sensory analyzer).CONCLUSIONS: The German CPAQ scale is a useful German-language instrument for the measurement of acceptance and shows good psychometric properties. The study confirms that acceptance is not an expression of a physiologically based indolence.

OBJECTIVE: To translate, to make the cultural adaptation and to evaluate reproducibility and validity of the Portuguese version of the AQUAREL (Assessment of QUAlity of life and RELated events) questionnaire, which is a specific tool to assess quality of life in pacemaker patients. METHODS: We evaluated 202 pacemaker patients: 63 patients during the cross-cultural adaptation stage and 139 during the reproducibility and validity evaluation stages. The questionnaire translation was reviewed repeatedly until > 85% of patients correctly understood the questions. Reproducibility of the final version was tested in 69 patients in whom the interview was performed twice by the same researcher. Validity was checked by the correlation between scores obtained in AQUAREL domains and those obtained in SF36 domains, in the functional class and the distance walked in the six-minute test. RESULTS: The internal consistency of AQUAREL was adequate, with Cronbachs alpha coefficient varying between 0.59 and 0.85. Reproducibility was good, with high correlation coefficients (0.68-0.89) and random distribution of data in Bland and Altman plots, without systematic bias. A significant association was observed among AQUAREL domains and those obtained in SF36 domains and the functional class (p<0.01), although significant correlations with the distance walked in the six-minute test were not found. CONCLUSION: The Portuguese version of the AQUAREL questionnaire is easy and rapid to apply, and could be used as a specific questionnaire to assess quality of life in pacemaker patients.