Determining Thresholds for Meaningful Change for the Headache Impact Test (HIT‐6) Total and Item‐Specific Scores in Chronic Migraine

Abstract Purpose We examined the reliability and validity of the 6-item Headache Impact Test (HIT-6) specifically on patients with chronic migraine (CM) from the PROMISE-2 clinical trial. Methods The conceptual framework of HIT-6 was evaluated using baseline data from the PROMISE-2 study (NCT02974153; N = 1072). A unidimensional graded response model within the item response theory (IRT) framework was used to evaluate model fit and item characteristics. Using baseline and week 12 data, convergent and discriminant validity of the HIT-6 was evaluated by correlation coefficients. Sensitivity to change was assessed by evaluating correlations between HIT-6 scores and change scores for other established reference measures. All examined correlations were specified a priori with respect to direction and magnitude. Known-groups analyses were anchored using Patient Global Impression of Change and monthly headache days at week 12. Results A unidimensional model fit the data well, supporting that the 6 items measure a single construct. All item slopes and thresholds were within acceptable ranges. In both the validity and sensitivity to change analyses, all observed correlations conformed to directional expectations, and most conformed to magnitude expectations. Known-groups analyses demonstrated that the HIT-6 total score can distinguish between clinically meaningful CM subgroups. Conclusion The HIT-6 was successfully calibrated using IRT with data from PROMISE-2. Results from these analyses were generally consistent with previous literature and provided supportive evidence that the HIT-6 is well suited for measuring the impact of headache and migraine in the CM population.

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Validation of the Headache Impact Test (HIT-6) in patients with chronic migraine

Health and Quality of Life Outcomes ◽

10.1186/s12955-014-0117-0 ◽

2014 ◽

Vol 12 (1) ◽

Cited By ~ 56

Author(s):

Regina Rendas-Baum ◽

Min Yang ◽

Sepideh F Varon ◽

Lisa M Bloudek ◽

Ronald E DeGryse ◽

...

Keyword(s):

Chronic Migraine ◽

Impact Test ◽

Headache Impact

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Determinants of pain interference and headache impact in patients who have chronic migraine with medication overuse: Results from the MOTS trial

Cephalalgia ◽

10.1177/03331024211006903 ◽

2021 ◽

pp. 033310242110069

Author(s):

Todd J Schwedt ◽

Soma Sahai-Srivastava ◽

Natalia Murinova ◽

Marius Birlea ◽

Zubair Ahmed ◽

...

Keyword(s):

Chronic Migraine ◽

Impact Test ◽

Medication Overuse ◽

Anxiety Symptoms ◽

Pain Interference ◽

Depression Symptoms ◽

Depression Symptom ◽

Negative Consequences ◽

Patient Reported ◽

Headache Impact

Objective “Pain interference” and “headache impact” refer to negative consequences that pain and headache have on one’s life. This study investigated determinants of these negative impacts in a large patient cohort who have chronic migraine with medication overuse. Methods Six hundred and eleven adults were enrolled from 34 headache, neurology, and primary care clinics. Negative consequences of chronic migraine with medication overuse were determined using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 6b questionnaire and the Headache Impact Test 6. Relationships between PROMIS-6b and Headache Impact Test 6 scores with demographics, headache characteristics, medication use, anxiety symptoms, and depression symptoms were assessed with linear regression. Elastic Net regression was used to develop a multiple regression model. Results PROMIS-6b T-Scores averaged 65.2 (SD 5.4) and Headache Impact Test 6 scores averaged 65.0 (SD 5.3), indicating severe negative consequences of chronic migraine with medication overuse. Chronic migraine with medication overuse interfered with enjoyment of life, concentration, daily activities, doing tasks away from home, and socializing. Depression symptom severity had the strongest relationship with pain interference and headache impact. Moderate-to-severe headache frequency, headache intensity, and anxiety symptoms were also associated with pain interference and headache impact. Conclusions Chronic migraine with medication overuse is associated with substantial negative consequences, the extent of which is most strongly related to depression symptoms.

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Chronic Migraine and Medication Overuse Headache Worsening After OnabotulinumtoxinA Withdrawn Due to the Severe Acute Respiratory Syndrome-Coronavirus-2 Pandemic

Frontiers in Neurology ◽

10.3389/fneur.2021.647995 ◽

2021 ◽

Vol 12 ◽

Author(s):

Carlo Baraldi ◽

Raffaele Ornello ◽

Valentina Favoni ◽

Simona Sacco ◽

Valeria Caponnetto ◽

...

Keyword(s):

Severe Acute Respiratory Syndrome ◽

Chronic Migraine ◽

Impact Test ◽

Rating Scale ◽

Medication Overuse Headache ◽

Rank Test ◽

Average Score ◽

Average Intensity ◽

Clinical Predictors ◽

Headache Impact

Introduction: OnabotulinumtoxinA (BT-A) is a preventive treatment for chronic migraine (CM), which needs to be administered regularly by a trained clinician every 3 months. The spread of the severe acute respiratory syndrome coronavirus-2 pandemic has forced many patients to momentarily stop the scheduled BT-A injections. The goal of this study was to explore whether those patients experienced a worsening of their CM and, if any, the clinical predictors of migraine worsening after BT-A withdrawal.Methods: This was a retrospective, multicenter study. Patients' clinical data were obtained from their clinical documentation stored at each center. In particular, the following variables were collected: the mean number of headache days in the last month (NHD), the average number of painkillers taken in the last month (AC), the average number of days in which patients took, at least, one painkiller in the last month (NDM), the average intensity of migraine using the numeric rating scale (NRS) score in the last month, and the average score obtained at the six-item Headache Impact Test. The variables mentioned earlier were compared before and after BT-A withdrawal.Results: After BT-A suspension, there was a significant increase in the NHD (P = 0.0313, Kruskal–Wallis rank test), AC (P = 0.0421, Kruskal–Wallis rank test), NDM (P = 0.0394, paired t-test), NRS score (P = 0.0069, Kruskal–Wallis rank test), and six-item Headache Impact Test score (P = 0.0372, Kruskal–Wallis rank test). Patients who were not assuming other preventive treatments other than BT-A displayed similar results. Patients who experienced a >30% worsening in NHD after BT-A was withdrawn displayed a longer CM history (P = 0.001, Kruskal–Wallis rank test), a longer MOH duration (P = 0.0017, Kruskal–Wallis rank test), a higher AC value at the baseline (P = 0.0149, Kruskal–Wallis rank test), a higher NDM (P = 0.0024, t-test), and a higher average value of the NRS score (P = 0.0073, Kruskal–Wallis rank test).Conclusion: BT-A withdrawn during severe acute respiratory syndrome coronavirus-2 pandemic was associated with a general worsening in patients suffering from CM, hence the need to continue BT-A injection to avoid patients' worsening.

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Case report: Manual therapies promote resolution of persistent post-concussion symptoms in a 24-year-old athlete

SAGE Open Medical Case Reports ◽

10.1177/2050313x20952224 ◽

2021 ◽

Vol 9 ◽

pp. 2050313X2095222

Author(s):

Susan Vaughan Kratz

Keyword(s):

Case Report ◽

Symptom Severity ◽

Impact Test ◽

Manual Therapies ◽

Symptom Checklist ◽

Post Concussion Syndrome ◽

Persistent Symptoms ◽

Short Period ◽

History Of ◽

Headache Impact

This case report illustrates the treatment outcomes of a collegiate athlete presenting with an 18-month history of post-concussion syndrome who received a series of mixed manual therapies in isolation of other therapy. Persistent symptoms were self-reported as debilitating, contributing to self-removal from participation in school, work, and leisure activities. Patient and parent interviews captured the history of multiple concussions and other sports-related injuries. Neurological screening and activities of daily living were baseline measured. Post-Concussion Symptom Checklist and Headache Impact Test-6™ were utilized to track symptom severity. Treatments applied included craniosacral therapy, manual lymphatic drainage, and glymphatic techniques. Eleven treatment sessions were administered over 3 months. Results indicated restoration of oxygen saturation, normalized pupil reactivity, and satisfactory sleep. Post-concussion syndrome symptom severity was reduced by 87% as reflected by accumulative Post-Concussion Symptom Checklist scores. Relief from chronic headaches was achieved, reflected by Headache Impact Test-6 scores. Restoration of mood and quality of life were reported. A 6-month follow-up revealed symptoms remained abated with full re-engagement of daily activities. The author hypothesized that post-concussion syndrome symptoms were related to compression of craniosacral system structures and lymphatic fluid stagnation that contributed to head pressure pain, severe sleep deprivation, and multiple neurological and psychological symptoms. Positive outcomes over a relatively short period of time without adverse effects suggest these therapies may offer viable options for the treatment of post-concussion syndrome.

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Effect of erenumab on functional outcomes in patients with episodic migraine in whom 2–4 preventives were not useful: results from the LIBERTY study

Journal of Neurology Neurosurgery & Psychiatry ◽

10.1136/jnnp-2020-324396 ◽

2021 ◽

pp. jnnp-2020-324396

Author(s):

Michel Lanteri-Minet ◽

Peter J Goadsby ◽

Uwe Reuter ◽

Shihua Wen ◽

Peggy Hours-Zesiger ◽

...

Keyword(s):

Functional Outcomes ◽

Impact Test ◽

Work Productivity ◽

Placebo Treatment ◽

Episodic Migraine ◽

Activity Impairment ◽

Everyday Activities ◽

Point Reduction ◽

Patient Reported ◽

Headache Impact

ObjectiveTo evaluate the effect of erenumab on patient-reported, functional outcomes in patients with episodic migraine (EM) in whom 2–4 preventives were not useful from the Phase 3b LIBERTY study.MethodsAs previously reported, 246 patients with EM with 2–4 prior failed preventives were randomised 1:1 to subcutaneous erenumab 140 mg or placebo every 4 weeks for 12 weeks. This analysis evaluated Migraine Physical Function Impact Diary (MPFID), Headache Impact Test (HIT-6) and Work Productivity and Activity Impairment (WPAI) scores at Week 12. P values were nominal without multiplicity adjustment.ResultsErenumab significantly improved MPFID-Physical Impairment (PI) and Everyday Activities (EA) scores versus placebo (treatment difference (TD) (95% CI) MPFID-PI: −3.5 (−5.7 to –1.2) (p=0.003); MPFID-EA: −3.9 (−6.1 to –1.7)) (p<0.001) at 12 weeks. Patients on erenumab were more likely to have a ≥5-point reduction in MPFID score (OR vs placebo (95% CI) MPFID-EA: 2.1 (1.2 to 3.6); MPFID-PI: 2.5 (1.4 to 4.5)). A similar trend was observed for HIT-6 (TD: −3.0; p<0.001); significantly higher proportions of patients on erenumab reported a ≥5-point reduction (OR (95% CI): 2.4 (1.4 to 4.1)). In three out of four WPAI domains, erenumab showed improvement versus placebo.ConclusionAt 12 weeks, erenumab was efficacious on functional outcomes in patients with EM in whom 2–4 preventives were not useful.Trial registration detailsClinicalTrials.gov identifier: NCT03096834.

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Reference Values for the Headache Impact Test-6 Questionnaire

Archives of Physical Medicine and Rehabilitation ◽

10.1016/j.apmr.2021.05.013 ◽

2021 ◽

Author(s):

Megan N. Houston ◽

Haley A. Bookbinder ◽

Sean P. Roach ◽

Jeremy D. Ross ◽

Michael J. Aderman ◽

...

Keyword(s):

Reference Values ◽

Impact Test ◽

Headache Impact

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Validation of the Headache Impact Test (HIT-6™) across episodic and chronic migraine

Cephalalgia ◽

10.1177/0333102410379890 ◽

2010 ◽

Vol 31 (3) ◽

pp. 357-367 ◽

Cited By ~ 146

Author(s):

Min Yang ◽

Regina Rendas-Baum ◽

Sepideh F Varon ◽

Mark Kosinski

Keyword(s):

Chronic Migraine ◽

Discriminant Validity ◽

High Reliability ◽

Reliability And Validity ◽

Episodic Migraine ◽

Migraine Headaches ◽

Scale Scores ◽

Headache Pain ◽

Test Retest Reliability ◽

Headache Impact

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.

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A Case Report on a Patient Treated with Combined Korean Medicine for Chronic Headache with Digestive Symptoms

The Journal of Internal Korean Medicine ◽

10.22246/jikm.2021.42.5.923 ◽

2021 ◽

Vol 42 (5) ◽

pp. 923-90

Author(s):

Gyu-cheol Choi ◽

Ji-eun Bae ◽

Jae-won Park ◽

Dong-jin Kim ◽

Jeong-su Hong

Keyword(s):

Medical Treatment ◽

Chronic Headache ◽

Impact Test ◽

Rating Scale ◽

Numerical Rating Scale ◽

Five Dimensions ◽

End Of Treatment ◽

Numerical Rating ◽

Headache Impact

Objectives: The purpose of this study was to examine the effect of combined Korean medical treatment on chronic headache with digestive symptoms.Methods: We collected data from October to December 2020 and evaluated the efficacy of combined Korean medical treatment using the Korean Headache Impact Test-g (KHIT-6), European Quality of Life Five Dimensions (EQ5D) Scale, and Numerical Rating Scale (NRS) at admission, after two weeks of hospitalization, and on discharge.Results: At the end of treatment, the patient had increased EQ5D and reduced KHIT-6 and NRS scores.Conclusions: After the combined Korean medical treatment, the patient showed improvement, suggesting the efficacy of treatment.

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Patient-Reported Outcomes from a 1-Year, Real-World, Head-to-Head Comparison of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine

Journal of Primary Care & Community Health ◽

10.1177/2150132720959936 ◽

2020 ◽

Vol 11 ◽

pp. 215013272095993 ◽

Cited By ~ 1

Author(s):

Andrew M. Blumenfeld ◽

Atul T. Patel ◽

Ira M. Turner ◽

Kathleen B. Mullin ◽

Aubrey Manack Adams ◽

...

Keyword(s):

Chronic Migraine ◽

Real World ◽

Patient Reported Outcomes ◽

Work Productivity ◽

Preventive Treatment ◽

Activity Impairment ◽

Treatment Benefit ◽

Study Results ◽

Patient Reported ◽

Headache Impact

Introduction/Objective: Chronic migraine (CM) is associated with impaired health-related quality of life and substantial socioeconomic burden, but many people with CM are underdiagnosed and do not receive appropriate preventive treatment. OnabotulinumtoxinA and topiramate have demonstrated efficacy (treatment benefit under ideal conditions) for the prevention of headaches in people with CM in clinical trials, but real-world studies suggest markedly different clinical effectiveness (treatment benefit based on a blend of efficacy and tolerability). This study sought to evaluate patient-reported outcomes (PROs) of onabotulinumtoxinA versus topiramate immediate release for people with CM. Methods: FORWARD was a prospective, multicenter, randomized, parallel-group, open-label, phase 4 study comparing onabotulinumtoxinA 155 U every 12 weeks with topiramate 50 to 100 mg/day for ≤36 weeks in people with CM. PROs measured included the Headache Impact Test (HIT-6), 9-item Patient Health Questionnaire Quick Depression Assessment (PHQ-9), Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP), and Functional Impact of Migraine Questionnaire (FIMQ). Results: A total of 282 patients were randomized and treated with onabotulinumtoxinA (n = 140) or topiramate (n = 142). From baseline to week 30, mean HIT-6 test scores improved significantly in patients taking onabotulinumtoxinA compared with topiramate ( P < .001). Improvements in depression over time were observed via larger changes in PHQ-9 scores with onabotulinumtoxinA than topiramate ( P < .001). Work productivity assessed via WPAI:SHP scores revealed significant improvements with onabotulinumtoxinA versus topiramate in Work Productivity Loss ( P = .024) and Activity Impairment ( P < .001) domains. Results from the FIMQ also revealed a larger reduction from baseline with onabotulinumtoxinA vs topiramate ( P < .0001). Conclusion: OnabotulinumtoxinA treatment had more favorable real-world effectiveness than topiramate on depression, headache impact, functioning and daily living, activity, and work productivity. The overall study results suggest that the beneficial effects on a range of PROs are the result of improved effectiveness when onabotulinumtoxinA is used as preventive treatment for CM. Trial Registration: ClinicalTrials.gov: NCT02191579; https://clinicaltrials.gov/ct2/show/NCT02191579

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