Reliability and validity of the 6-item Headache Impact Test in chronic migraine from the PROMISE-2 study.
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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.
SUBMITTER: Houts CR
PROVIDER: S-EPMC7952287 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveThe objective of the analyses described here was to develop thresholds defining clinically meaningful response on the total and item scores of the 6-item short-form Headache Impact Test (HIT-6) in a population of patients with chronic migraine (CM).BackgroundThe HIT-6 is a short, easily understood, and useful measure of the impact of headache on daily life. Though widely used, limited literature supports a threshold value for clinically meaningful response within individuals over time for the HIT-6 total score and for the item scores, especially in the CM population.MethodsPROMISE-2 is a randomized, double-blind, multicenter study comparing intravenous eptinezumab 100 and 300 mg with placebo for the preventive treatment of CM. Responder definitions for HIT-6 total and items scores using data from PROMISE-2 study were calculated via distribution-based and anchor-based methods. Distribution-based methods included half of the baseline standard deviation and baseline standard error of measurement. The change from baseline to week 12 in HIT-6 scores was assessed using the following anchors: patient global impression of change, reduction in migraine frequency, and change in EuroQol 5 dimensions 5 levels visual analog scale. Values from the literature and PROMISE-2 analyses were plotted against the cumulative distribution function of change values (baseline to week 12) and used to triangulate to empirically support clinically meaningful change definitions for the HIT-6 total and item scores in patients with CM.ResultsFrom the literature, 5 articles provided 7 candidate values for a responder threshold for the HIT-6 total score. From distribution- and anchor-based methods, 5 candidate values were derived from PROMISE-2 data. Using the median of all candidate values, a HIT-6 total score responder definition estimate of -6 (ie, ≥6-point improvement in the total score) appears most appropriate for discriminating between individuals with CM who have experienced meaningful change over time and those who have not. For item-level analyses using anchor-based methods, the responder definition for items 1-3 ("severe pain," "limits daily activities," and "lie down") was a 1-category improvement in response (eg, from Sometimes to Rarely); for items 4-6 ("too tired," "felt fed up or irritated," and "limits concentration"), a 2-category improvement in response (eg, from Always to Sometimes) was clinically meaningful.ConclusionsUsing a multifaceted, statistically-based approach, the recommended responder definition for the HIT-6 total score in the CM population is a ≥6-point decrease, consistent with previous literature. Anchor-based item-level responder thresholds were defined as a decrease of 1 or 2 categories, depending on the item. These CM-specific values will provide researchers and clinicians a means to interpret clinically meaningful change in the HIT-6 total and item scores and may facilitate the measurement of treatment benefits in specific functional domains of the HIT-6.
| S-EPMC7693226 | biostudies-literature
Project description:BackgroundThe Headache Impact Test (HIT)-6 was developed and has been validated in patients with various types of headache. The objective of this study was to report the psychometric properties of the HIT-6 among patients with chronic migraine.MethodsData came from two international, multicenter, randomized, double-blind, placebo-controlled clinical trials of chronic migraine patients (N = 1,384) undergoing prophylaxis therapy. Confirmatory factor analysis and differential item functioning (DIF) analysis were used to test the latent structure and cross-cultural comparability of the HIT-6. Reliability, construct validity, and responsiveness were assessed. Two sets of criterion groups were used: (1) 28-day headache frequency: <10, 10-14, and ≥15 days; (2) sample quartiles of the total cumulative hours of headache: <140, 140 to <280, 280 to <420, and ≥420 hours. Two sets of responsiveness categories were defined as reduction of <30%, 30% to <50%, or ≥50% in (1) number of headache days and (2) cumulative hours of headache.ResultsMeasurement invariance tests supported the stability of the HIT-6 latent structure across studies. DIF analysis supported cross-cultural comparability. Good reliability was observed across studies (Cronbach's α: 0.75-0.92; intraclass correlation coefficient: 0.76-0.80). HIT-6 scores correlated strongly (-0.86 to -0.59) with scores of the Migraine-Specific Quality-of-Life Questionnaire. Analysis of variance indicated that HIT-6 scores discriminated across both types of criterion groups (P<0.001), across studies and time points. HIT-6 change scores were significantly higher in magnitude in groups experiencing greater improvement (P<0.001).ConclusionAll measurement properties were consistently verified across the two studies, supporting the validity of the HIT-6 among chronic migraine patients.Trial registrationNCT00156910 and NCT00168428 on www.ClinicalTrials.gov.
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Project description:Background/aimThe measurement of self-efficacy is an important step toward improving chronic disease management, enhancing adherence to treatment, and assessing patients with chronic diseases. The purpose of this study was to assess the validity and reliability of the Turkish version of the Self-Efficacy for Managing Chronic Disease 6-Item Scale.Materials and methodsIn this methodological study, the sample consisted of 211 patients receiving chronic disease care in 2 family health centers in İstanbul, Turkey. Data were analyzed with descriptive statistics, exploratory and confirmatory factor analyses, concurrent validity, Cronbach’s alpha, item-total correlation, and test-retest reliability.ResultsMost of the sample were women (72%), primary school graduates (41.7%), hypertensive (68.7%), and had comorbidities (68.2%). The mean age of the sample was 60.5 ± 10.9. The scale mean was 5.66 ± 2.28. Cronbach’s alpha reliability was 0.90. Item-total correlations were between 0.64–0.85 and test-retest reliability was high (R = 0.95, P < 0.001). A positive, significant correlation was found in concurrent validity. According to the results of factor analysis, the scale had a 2-dimensional structure.ConclusionThe Turkish version of the Self-Efficacy for Managing Chronic Disease 6-Item Scale is a valid and reliable instrument to assess perceived the self-efficacy level of patient with chronic disease.
| S-EPMC7491285 | biostudies-literature
Project description:To improve and support medication adherence among patients with chronic diseases, especially for long-term medication, it is important to consider both their relationship with healthcare providers and their lifestyle. We tested the reliability and validity of a modified 12-item Medication Adherence Scale.We revised a 14-item measure of medication adherence, created in 2009, to a more concise and clear 12-item version, and we verified the reliability and validity of the 12-item scale. We included 328 patients with chronic diseases participating in the Chronic Disease Self-Management Program in Japan from 2011 to 2014. Confirmatory factor analysis was used to assess whether the four factors assessed were the same as the previous 14-item Medication Adherence Scale. Cronbach's coefficient alpha was used to assess internal consistency reliability, and the relationships between patient demographic characteristics and medication adherence were compared with previous studies.The 12 items were categorized into the four factors "medication compliance", "collaboration with healthcare providers", "willingness to access and use information about medication", and "acceptance to take medication and how taking medication fits patient's lifestyle". Confirmatory factor analysis showed ?2/df?=?2.6, CFI?=?0.94, and RMSEA?=?0.069. Cronbach's alpha for the 12-item scale was 0.78. Cronbach's alpha for the four subscales was 0.74, 0.81, 0.67, and 0.45. Higher medication adherence was significantly associated with being a female patient, living with someone else, and age 40-49 years versus age 20-29 years. These relationships were the same as in previous studies.We modified our original 14-item scale to a 12-item Medication Adherence Scale for patients with chronic diseases, which considers their relationship with healthcare providers and lifestyle. Refinement might be needed because of the relatively low reliability of subscales. However, the modified scale is expected to contribute to more effective self-management of medication and to improving medication adherence, particularly among patients with chronic diseases who require long-term medication not only in Japan but also in other countries.
| S-EPMC6069892 | biostudies-other
Project description:ObjectiveTo evaluate the feasibility, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS) for the prevention of chronic migraine (CM) attacks.MethodsIn this first prospective, multicenter, double-blind, sham-controlled pilot study of nVNS in CM prophylaxis, adults with CM (≥15 headache d/mo) entered the baseline phase (1 month) and were subsequently randomized to nVNS or sham treatment (2 months) before receiving open-label nVNS treatment (6 months). The primary endpoints were safety and tolerability. Efficacy endpoints in the intent-to-treat population included change in the number of headache days per 28 days and acute medication use.ResultsFifty-nine participants (mean age, 39.2 years; mean headache frequency, 21.5 d/mo) were enrolled. During the randomized phase, tolerability was similar for nVNS (n = 30) and sham treatment (n = 29). Most adverse events were mild/moderate and transient. Mean changes in the number of headache days were -1.4 (nVNS) and -0.2 (sham) (Δ = 1.2; p = 0.56). Twenty-seven participants completed the open-label phase. For the 15 completers initially assigned to nVNS, the mean change from baseline in headache days after 8 months of treatment was -7.9 (95% confidence interval -11.9 to -3.8; p < 0.01).ConclusionsTherapy with nVNS was well-tolerated with no safety issues. Persistent prophylactic use may reduce the number of headache days in CM; larger sham-controlled studies are needed.Clinicaltrialsgov identifierNCT01667250.Classification of evidenceThis study provides Class II evidence that for patients with CM, nVNS is safe, is well-tolerated, and did not significantly change the number of headache days. This pilot study lacked the precision to exclude important safety issues or benefits of nVNS.
| S-EPMC4970666 | biostudies-literature
Project description:Aims:Migraine is a global phenomenon, affecting more than 10% of the world's population. It is characterized by unilateral headache that may be accompanied by vomiting, nausea, photophobia and phonophobia. Some patients with chronic migraine respond to extra-cranial botulinum toxin type A injection, although the benefits observed are temporary. The rationale for surgical trigger site deactivation is to achieve lasting symptomatic improvement or permanent relief from migraine. Methods:We performed a PRISMA-compliant systematic review of clinical studies evaluating surgical intervention for migraine by searching Ovid MEDLINE and EMBASE databases from inception to June 2017. Studies were independently screened by two authors. Data were extracted on study characteristics, migraine outcomes, adverse events and recurrence. The quality of evidence was assessed using the GRADE approach. The review protocol was prospectively registered on the PROSPERO database (CRD42017068577). Results:The search strategy identified 789 articles; of them, 18 studies (4 RCTs and 14 case series) were eligible for analysis. Surgical interventions were heterogeneous and variably involved peripheral nerve decompression by myectomy or foraminotomy, nerve excision, artery resection and/or nasal surgery. All studies reported significant reductions in migraine intensity, frequency, duration and composite headache scores following surgery. Study heterogeneity precluded formal meta-analysis. Where reported, adverse event rates varied markedly between studies. The quality of included studies was consistently low or very low. Conclusion:There is insufficient evidence to support the effectiveness of any specific surgical intervention for chronic migraine, especially with regard to permanent relief; however, all included studies report improvements in key outcomes following migraine surgery. A definitive, well-powered RCT with objective surgical and patient-reported outcome measures and robust adverse event reporting is required.
| S-EPMC7061614 | biostudies-literature
Project description:ObjectiveTo compare the clinical phenotype of patients with chronic migraine (CM) to patients with new daily persistent headache of the chronic migraine subtype (NDPH-CM).MethodsA study was conducted of CM (n = 257) and NDPH-CM (n = 76) from a tertiary headache center in the UK, and in the US of patients with daily CM (n = 60) and NDPH-CM (n = 22).ResultsFrom the UK cohort, the age of first headache onset was lower in CM (mean ± SD: 16 ± 12 years) than in NDPH-CM (mean ± SD: 23 ± 14 years; p < 0.001). There was a greater number of associated migrainous symptoms in CM compared to NDPH-CM (median and interquartile range: 6, 5-8 vs. 5, 4-7; p < 0.001). A family history of headache was more common in CM compared to NDPH-CM (82%, 202/248, vs. 53%, 31/59; p < 0.001). In the US cohort there were no differences. Osmophobia (B = -1.08; p = 0.002) and older age at presentation to the clinic (B = -0.06; p = 0.001) were negative predictors of NDPH-CM.ConclusionNDPH-CM is relatively less migrainous than CM in the UK cohort. Family history of headache is less common in NDPH-CM, with negative predictors for NDPH-CM including osmophobia and older age of presentation to the clinic. More work is required to understand the chronic migraine phenotype of new daily persistent headache.
| S-EPMC9545870 | biostudies-literature
Project description:ObjectiveThis post hoc analysis in patients medically diagnosed with chronic migraine (CM) and medication-overuse headache (MOH) evaluated reductions in the use of acute headache medication (AHM) and sustained changes in the diagnostic status of CM and MOH following eptinezumab treatment in the PROMISE-2 study.BackgroundEptinezumab, a monoclonal antibody that inhibits calcitonin gene-related peptide, is approved in the United States for the preventive treatment of migraine. A previous analysis showed that eptinezumab reduced monthly migraine days and was well tolerated in the subgroup of PROMISE-2 patients diagnosed with both CM and MOH.MethodsThe phase 3, double-blind, placebo-controlled PROMISE-2 study (NCT02974153) randomized adults with CM to eptinezumab 100 mg, 300 mg, or placebo (administered intravenously every 12 weeks for up to two doses). MOH was prospectively diagnosed at screening by trained physicians based on 3 months of medication history and International Classification of Headache Disorders-3β criteria. This post hoc analysis evaluated changes in total and class-specific days of AHM usage, the percentage of patients using AHM at or above MOH diagnostic thresholds, and the percentage of patients experiencing monthly headache and migraine day frequency below diagnostic thresholds for MOH and/or CM.ResultsIn PROMISE-2, 431/1072 (40.2%) patients with CM were diagnosed with MOH (eptinezumab 100 mg, n = 139; 300 mg, n = 147; placebo, n = 145) and were included in this analysis. Total monthly AHM use decreased from 20.6 days/month at baseline to 10.6 days/month over 24 weeks of treatment (49% decrease) with eptinezumab 100 mg, from 20.7 to 10.5 days/month (49% decrease) with eptinezumab 300 mg, and from 19.8 to 14.0 days/month (29% decrease) with placebo. Numerically greater decreases from baseline with eptinezumab were also observed for individual drug classes. In each study month, the percentages of patients who were below MOH thresholds were numerically higher for both eptinezumab doses compared with placebo, as were the percentages of patients experiencing headache and migraine frequency below CM thresholds. Of patients with available data across the entire treatment period, 29.0% (58/200) of patients treated with eptinezumab stopped meeting and remained below diagnostic thresholds for both CM and MOH during Weeks 1-24, as well as 6.3% (6/96) of patients who received placebo.ConclusionsAcross 24 weeks of treatment, eptinezumab reduced AHM use in patients diagnosed with CM and MOH. More than one-fourth (29%) of patients treated with eptinezumab did not meet the diagnostic thresholds for either CM or MOH for the entire treatment period.
| S-EPMC9291601 | biostudies-literature
Project description:ObjectivePostural instability and gait disturbance are the cardinal symptoms associated with falling among patients with Parkinson's disease (PD). The Tinetti mobility test (TMT) is a well-established measurement tool used to predict falls among elderly people. However, the TMT has not been established or widely used among PD patients in Korea. The purpose of this study was to evaluate the reliability and validity of the Korean version of the TMT for PD patients.MethodsTwenty-four patients diagnosed with PD were enrolled in this study. For the interrater reliability test, thirteen clinicians scored the TMT after watching a video clip. We also used the test-retest method to determine intrarater reliability. For concurrent validation, the unified Parkinson's disease rating scale, Hoehn and Yahr staging, Berg Balance Scale, Timed-Up and Go test, 10-m walk test, and gait analysis by three-dimensional motion capture were also used. We analyzed receiver operating characteristic curve to predict falling.ResultsThe interrater reliability and intrarater reliability of the Korean Tinetti balance scale were 0.97 and 0.98, respectively. The interrater reliability and intra-rater reliability of the Korean Tinetti gait scale were 0.94 and 0.96, respectively. The Korean TMT scores were significantly correlated with the other clinical scales and three-dimensional motion capture. The cutoff values for predicting falling were 14 points (balance subscale) and 10 points (gait subscale).ConclusionWe found that the Korean version of the TMT showed excellent validity and reliability for gait and balance and had high sensitivity and specificity for predicting falls among patients with PD.
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Project description:ObjectiveChild and youth mental health problems are often assessed by parent self-completed checklists that produce dimensional scale scores. When converted to binary ratings of disorder, little is known about their psychometric properties in relation to classifications based on lay-administered structured diagnostic interviews. In addition to estimating agreement, our objective is to test for statistical equivalence in the test-retest reliability and construct validity of two instruments used to classify child emotional, behavioural, and attentional disorders: the 25-item, parent completed Ontario Child Health Study Emotional Behavioural Scales-Brief Version (OCHS-EBS-B) and the Mini International Neuropsychiatric Interview for Children and Adolescents-parent version (MINI-KID-P).MethodsThis study draws on independent samples (n = 452) and uses the confidence interval approach to test for statistical equivalence. Reliability is based on kappa (κ). Construct validity is based on standardized beta coefficients (β) estimated in structural equation models.ResultsThe average differences between the MINI-KID-P and OCHS-EBS-B in κ and β were -0.022 and -0.020, respectively. However, in both instances, criteria for statistical equivalence were met in only 5 of 12 comparisons. Based on κ, between-instrument agreement on the classifications of disorder went from 0.481 (attentional disorder) to 0.721 (emotional disorder) but were substantially higher (0.731 to 0.895, respectively) when corrected for attenuation due to measurement error.ConclusionsAlthough falling short of equivalence, the results suggest on balance that the reliability and validity of the two instruments for classifying child psychiatric disorder assessed by parents are highly comparable. This conclusion is supported by the high levels of agreement between the instruments after correcting for attenuation due to measurement error.
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