Publications by authors named "James S McGinley"
Objective: To better understand the breadth and frequency of symptoms across the phases of the migraine cycle using data captured from qualitative patient interviews conducted through the Migraine Clinical Outcome Assessment System (MiCOAS) project.
Background: People living with migraine experience a range of symptoms across the pre-headache, headache, post-headache, and interictal phases of the migraine cycle. Although clinical diagnostic criteria and clinical trial endpoints focus largely on cardinal symptoms or monthly migraine days, migraine symptom profiles are far more complex.
Objective: To describe the impact of migraine on functioning based on comprehensive data collection, analysis, and reporting of patients' experiences.
Background: Qualitative 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.
Methods: Qualitative 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.
Objective: The objective of this study was to characterize the utility of calcitonin gene-related peptide (CGRP) and nerve growth factor (NGF) as potential biomarkers for headache and pain disorders in the post-military deployment setting.
Background: The need to improve recognition, assessment, and prognoses of individuals with posttraumatic headache or other pain has increased interest in the potential of CGRP and NGF as biomarkers.
Methods: The Warrior Strong Study (NCT01847040) is an observational longitudinal study of United States-based soldiers who had recently returned from deployment to Afghanistan or Iraq from 2009 to 2014.
Background: There is renewed emphasis on including patients in determining, defining, and prioritizing outcomes for migraine treatment.
Objectives: To obtain insights directly from people living with migraine on their priorities for treatment.
Methods: A total of 40 qualitative interviews were conducted as part of the Migraine Clinical Outcome Assessment System project, a United States Food and Drug Administration grant-funded program to develop a core set of patient-centered outcome measures for migraine clinical trials.
Objectives: To capture patients' perspectives on migraine-related cognitive symptoms during pre-headache, headache, post-headache, and interictal periods.
Background: Migraine-related cognitive symptoms are reported by people with migraine both during and between attacks. Associated with disability, they are increasingly viewed as a priority target for treatment.
Objective: To investigate the links between adolescent migraine and comorbid and co-occurring conditions using a large, nationally representative longitudinal study.
Background: Comorbidities and co-occurring conditions play an important role in the clinical treatment of individuals with migraine. Research in this area has focused largely on the adult population using cross-sectional data, but less is known about adolescents and how conditions may co-occur over time from a broader developmental perspective.
In 1995, a committee of the International Headache Society developed and published the first edition of the These have not been revised. With the emergence of new medications, neuromodulation devices and trial designs, an updated version of the International Headache Society is warranted. Given the scarcity of evidence-based data for cluster headache therapies, the update is largely consensus-based, but takes into account lessons learned from recent trials and demands by patients.
View Article and Find Full Text PDFObjective: To assess the utility of the novel patient-identified (PI) most bothersome symptom (MBS) measure from PROMISE-2, a phase 3 trial of eptinezumab for the preventive treatment of chronic migraine.
Background: Relief of bothersome migraine symptoms can influence satisfaction with treatment and therapeutic persistence. Understanding the impact of preventive treatment on a PI-MBS could improve clinical decision-making.
Background: The coronavirus disease 2019 (COVID-19) pandemic is an ongoing global health crisis that has had a range of impacts on people living with migraine.
Methods: Qualitative interviews performed as part of the Migraine Clinical Outcome Assessment System project, a multi-stage Food and Drug Administration-grant funded program to develop a patient-centered core set of outcome measures for use in migraine clinical trials, offered an opportunity to explore the experience of living with migraine during the pandemic as well as to examine whether migraine treatment priorities, symptoms, and associated disability changed due to the pandemic. Semi-structured interviews were conducted in the United States between the summer and fall of 2020 with 40 individuals with self-reported, medically diagnosed migraine who self-reported that they had not tested positive for or been diagnosed with COVID-19.
Objective: Though migraine is thought of as a symptom complex, symptoms are typically assessed one at a time. For use in clinical research, we developed a composite measure of headache day severity by combining eight well-known symptoms captured in daily diaries.
Subjects And Methods: Data came from adults with a self-reported diagnosis of migraine (n = 4380) who provided daily diary information assessed using a novel digital platform.
In recent years, emphasis has been placed on conducting headache research that is patient-centered to more explicitly incorporate the input of people who live with headache diseases. The Growing Up with Migraine Study was developed with this intention using a two-step process: 1. develop and administer a survey to identify research areas that matter most to people with adolescent migraine and/or their caregivers and 2.
View Article and Find Full Text PDFBackground/objective: To review the acute migraine clinical trial literature and provide a summary of the endpoints and outcomes used in such trials.
Method: A systematic literature review, following a prespecified (but unregistered) protocol developed to adhere to recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses, was conducted to understand endpoints and outcomes used in acute migraine clinical trials. Predefined terms were searched in PubMed to locate clinical trials assessing acute migraine treatments.
Objective: To investigate between and within-woman differences in the association between menstruation and migraine days.
Background: Prior diary studies have shown that at the population level, aggregating across individuals, the odds of migraine increase during the perimenstrual window (from day -2 to day +3, where +1 is the first day of bleeding). These studies have been neither long nor large enough to assess the association between migraine and menses from an individual perspective.
Background: Over the last six decades (earliest included publication from 1959), clinical trials of migraine preventive treatments have led to the regulatory approval of many medications and devices. Despite similar clinical goals, the outcomes and endpoints used in these trials are broad and not well standardized.
Objective: To describe results from a systematic literature review focused on outcomes and endpoints used in preventive migraine clinical trials.
Background: Post-traumatic headaches are a common sequela of mild traumatic brain injury (concussion). It is unclear whether or how these headaches differ phenotypically from primary headaches.
Objective: Determine whether there is an overarching unobserved latent trait that drives the expression of observed features of post-traumatic headache and other headaches.
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.
Objective: The 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).
Background: The 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.
Background: The short-form Headache Impact Test (HIT-6) is a widely used patient-reported outcome measure that assesses the negative effects of headaches on normal activity. It was developed using the general headache population and prior to the establishment of the now well-accepted FDA patient-reported guidance.
Objective: The objective of this narrative review was to examine existing qualitative research in patients with migraine and headache, providing insight into the relevance and meaningfulness of HIT-6 items to the lives of migraine patients.
Objective: Using electronic diaries as part of a randomized controlled trial of stress reduction for epilepsy, we evaluated factors associated with successful seizure self-prediction.
Methods: Adults with medication-resistant focal epilepsy were recruited from 3 centers and randomized to treatment with progressive muscle relaxation or control focused attention. An 8-week baseline was followed by 12 weeks of double-blind treatment.
Background: Consistency of response across multiple attacks is typically measured as the proportion of study participants who achieve a categorical endpoint over a specified number of attacks (ie, 2-hour pain-free response in 2 of 3 attacks). We applied a novel analytic approach for measuring consistency of response in the acute treatment of episodic migraine using data from the COMPASS study.
Methods: The COMPASS study (NCT01667679) was a multiple attack crossover study which compared AVP-825, a Breath Powered intranasal delivery system for low-dose sumatriptan powder (22 mg), with 100-mg oral sumatriptan tablets in the acute treatment of migraine.
Objective: To introduce growth curve modeling for longitudinal headache research.
Background: Longitudinal data play an important role in the study of headache-related outcomes by allowing researchers to test hypotheses about change over time. However, headache researchers are often unfamiliar with the flexibility and power that growth curves can offer in analyzing longitudinal data.
The current study demonstrates the application of an analytic approach for incorporating multiple time trends in order to examine the impact of cohort effects on individual trajectories of eight drugs of abuse. Parallel analysis of two independent, longitudinal studies of high-risk youth that span ages 10 to 40 across 23 birth cohorts between 1968 and 1991 was conducted. The two studies include the Michigan Longitudinal Study (current analytic sample of n=579 over 12 cohorts between 1980-1991 and ages 10-27) and the Adolescent/Adult and Family Development Project (current analytic sample of n=849 over 11 cohorts between 1968-1978 and ages 10-40).
View Article and Find Full Text PDFBackground: Migraine-related nausea is associated with significant disability, increased burden of disease, and personal distress. Nausea can lead to delays or avoidance of initiating oral migraine treatment, sometimes resulting in treatment failures and poor outcomes. Nausea is often a symptom of migraine, but nausea may also be a consequence of treatment (ie, treatment emergent nausea [TEN]).
View Article and Find Full Text PDFBackground: Fast relief of migraine pain, associated symptoms, and migraine-related disability are priorities in the acute treatment of migraine. Efforts to improve the pharmacokinetic profiles of acute migraine treatments with the aim of providing faster relief include the development of non-oral routes of administration. AVP-825 (ONZETRA Xsail ) is a delivery system containing 22 mg sumatriptan powder that uses a patient's own breath to deliver medication intranasally, targeting the upper posterior nasal cavity beyond the narrow nasal valve, an area lined with vascular mucosa conducive to rapid drug absorption into the systemic circulation.
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