The use of clinical scales and PROMs in headache disorders and migraine, summarizing their dissemination and operationalization

Dikmen, Pınar Yalınay; Özge, Aynur; Martelletti, Paolo

doi:10.1016/j.heliyon.2023.e16187

Cited by 9 publications

(8 citation statements)

References 94 publications

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“…These findings are aligned with, but add detail and specificity to, existing published qualitative research on patient experiences with migraine 27 . Some of these concepts have already been used in PROMs for headache or migraine, which often include questions about physical and emotional functioning; 28,29 however, findings suggest that measurement of some concepts could be improved and that other concepts may be missing from many existing measures. For instance, the MFIQ v. 2 18 includes a question about taking care of family which could result in a missed opportunity to capture impacts on people who have responsibilities for caring for friends, neighbors, or pets.…”

Section: Discussionsupporting

confidence: 58%

The impacts of migraine on functioning: Results from two qualitative studies of people living with migraine

Mangrum,

Bryant,

Gerstein

et al. 2024

Headache

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ObjectiveTo describe the impact of migraine on functioning based on comprehensive data collection, analysis, and reporting of patients' experiences.BackgroundQualitative research conducted to understand patients' perspectives on living with migraine has often focused on narrow topics or specific groups of patients or has been selectively reported.MethodsQualitative interviews with 71 participants were conducted during two concept elicitation studies as part of the Migraine Clinical Outcome Assessment System (MiCOAS) project, an FDA grant‐funded program designed to develop a core set of patient‐centered outcome measures for migraine clinical trials. Participants self‐reported being diagnosed with migraine by a healthcare professional and participated in semi‐structured qualitative interviews about their experiences with the symptoms and impacts of migraine. Interview transcripts were coded to identify and define concepts, which were then grouped into broad domains based on conceptual similarities.ResultsA total of 66 concepts were identified: 12 for physical functioning, 16 for cognitive functioning, 10 for social role functioning, 19 for emotional and psychological functioning, and 9 related to migraine management. Participants described a complex and varied relationship between migraine attack symptoms and impacts on functioning. Impacts from migraine were further influenced by numerous contextual factors, such as people's individual social environments and the level of day‐to‐day demand for functioning they face.ConclusionFindings showed that migraine impacted individual functioning in multiple ways and the nature of these impacts was dependent on social‐contextual factors. The results are being used in the development of core measures designed to improve our understanding of the burden of migraine and the efficacy of migraine therapies. The results also offer new insights and raise new questions about migraine experience that can be used to guide future research.

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Section: Discussionsupporting

confidence: 58%

The impacts of migraine on functioning: Results from two qualitative studies of people living with migraine

Mangrum,

Bryant,

Gerstein

et al. 2024

Headache

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“…Second, HIT-6 is a 1-month recall of headache impact compared to the recall period for MIDAS (3 months). 43,44 On the other hand, the change score in HIT-6 showed a moderate degree of correlation with change scores of VAS (r = 0.688), while a fair degree with the MMDs (r = 0.403); however, no significant correlation was found with the change scores of MIDAS. The assumption that headache's impact on an individual's quality of life could be related to the severity and intensity of headache attacks rather than the numerical MMDs could explain this finding.…”

Section: Discussionmentioning

confidence: 89%

Reliability, validity, and responsiveness of the Arabic version of HIT‐6 questionnaire in patients with migraine indicated for preventive therapy: A multi‐center study

Hussein,

Hassan,

Nada

et al. 2024

Headache

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BackgroundThe Headache Impact Test (HIT‐6) is an important patient‐reported outcome measure (PROM) in migraine prevention trials.ObjectivesThis study aimed to (i) assess the reliability and validity of the Arabic version of HIT‐6 in Arabic‐speaking patients experiencing migraine, and (ii) evaluate the responsiveness of HIT‐6 following migraine preventive therapy.MethodsIn this prospective study, patients with migraine (n = 145) were requested to fill out a headache diary, the Arabic version of HIT‐6, and Migraine Disability Assessment Scale (MIDAS) at two time points (baseline and 3 months after initiation of prophylactic treatment). Some respondents (n = 73) were requested to fill out HIT‐6 again 1 week from the baseline for test–retest reliability. The intensity of migraine headache attacks was evaluated using the Visual Analogue Scale (VAS). An anchor‐based method was used to establish the minimal important change (MIC) value and responsiveness of HIT‐6.ResultsThe total scores of HIT‐6 were significantly correlated to a fair degree with MIDAS (r = 0.41), as well as VAS (r = 0.53), and monthly migraine days (r = 0.38) at the baseline while at the follow‐up (after 3 months), the correlations were of moderate degree with MIDAS scores (r = 0.62) and monthly migraine days (r = 0.60; convergent validity). Reliability estimates of the Arabic HIT‐6 were excellent (Cronbach's α = 0.91 at baseline and 0.89 at follow‐up). The average measure interclass correlation coefficient (ICC) value for the test–retest reliability was 0.96 (95% confidence interval = 0.94–0.98, p < 0.001). The HIT‐6 total score is sensitive to change, being significantly reduced after prophylactic treatment compared to before (effect size = 1.5, standardized response mean = 1.3). A reduction from baseline of 4.5 on HIT‐6 showed the highest responsiveness to predict improvement with an area under the curve equal to 0.66, sensitivity of 80%, specificity of 45%, and significance at 0.021. Changes in the HIT‐6 total score were positively correlated with changes in monthly migraine days (r = 0.40) and VAS scores (r = 0.69) but not with changes in the score of MIDAS (r = 0.07).ConclusionThe Arabic version of HIT‐6 is valid, reliable, and sensitive to detect clinical changes following migraine prophylactic treatment with a MIC of 4.5 points.

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“…Translating a subjective experience such as headache into an objective context is challenging. Using headache assessment instruments (including headache diaries) with established validity in specific patient groups is recommended [ 58 ]. Unfortunately, such instruments were not available in this study.…”

Section: Discussionmentioning

confidence: 99%

Frequency and predictors of headache in the first 12 months after traumatic brain injury: results from CENTER-TBI

Howe,

Andelic,

Brunborg

et al. 2024

J Headache Pain

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Background Headache is a prevalent and debilitating symptom following traumatic brain injury (TBI). Large-scale, prospective cohort studies are needed to establish long-term headache prevalence and associated factors after TBI. This study aimed to assess the frequency and severity of headache after TBI and determine whether sociodemographic factors, injury severity characteristics, and pre- and post-injury comorbidities predicted changes in headache frequency and severity during the first 12 months after injury. Methods A large patient sample from the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) prospective observational cohort study was used. Patients were stratified based on their clinical care pathway: admitted to an emergency room (ER), a ward (ADM) or an intensive care unit (ICU) in the acute phase. Headache was assessed using a single item from the Rivermead Post-Concussion Symptoms Questionnaire measured at baseline, 3, 6 and 12 months after injury. Mixed-effect logistic regression analyses were applied to investigate changes in headache frequency and associated predictors. Results A total of 2,291 patients responded to the headache item at baseline. At study enrolment, 59.3% of patients reported acute headache, with similar frequencies across all strata. Female patients and those aged up to 40 years reported a higher frequency of headache at baseline compared to males and older adults. The frequency of severe headache was highest in patients admitted to the ICU. The frequency of headache in the ER stratum decreased substantially from baseline to 3 months and remained from 3 to 6 months. Similar trajectory trends were observed in the ICU and ADM strata across 12 months. Younger age, more severe TBI, fatigue, neck pain and vision problems were among the predictors of more severe headache over time. More than 25% of patients experienced headache at 12 months after injury. Conclusions Headache is a common symptom after TBI, especially in female and younger patients. It typically decreases in the first 3 months before stabilising. However, more than a quarter of patients still experienced headache at 12 months after injury. Translational research is needed to advance the clinical decision-making process and improve targeted medical treatment for headache. Trial registration ClinicalTrials.gov NCT02210221.

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The use of clinical scales and PROMs in headache disorders and migraine, summarizing their dissemination and operationalization

Cited by 9 publications

References 94 publications

The impacts of migraine on functioning: Results from two qualitative studies of people living with migraine

The impacts of migraine on functioning: Results from two qualitative studies of people living with migraine

Reliability, validity, and responsiveness of the Arabic version of HIT‐6 questionnaire in patients with migraine indicated for preventive therapy: A multi‐center study

Frequency and predictors of headache in the first 12 months after traumatic brain injury: results from CENTER-TBI

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