RESUMO
OBJECTIVE: To qualitatively and quantitatively summarize the evidence for the use of onabotulinumtoxinA injections in children and adolescents with migraine. BACKGROUND: There are limited evidence-based treatment options for youth with migraine, especially youth with chronic migraine (CM). OnabotulinumtoxinA injections are an established evidence-based treatment for adults with CM. While several studies have assessed their safety and efficacy among adolescents with CM, there are no published systematic reviews summarizing the pediatric evidence. METHODS: We carried out a systematic review, reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis, aiming to identify studies that included five or more children and adolescents aged ≤18 years with a diagnosis of migraine, who were treated with ≥50 units (U) of onabotulinumtoxinA and had outcomes assessed ≥4 weeks after one or more injection cycle. Both observational studies and randomized controlled trials (RCTs) were eligible for inclusion. Two investigators independently carried out the first (titles and abstracts) and second (full text) screening stages, as well as data extraction and quality appraisal. The American Academy of Neurology risk of bias grading scheme was used to assess study risk of bias. Studies with adequate data were pooled using random effects meta-analyses, and Hedge's g standardized mean differences with 95% confidence intervals (CIs) were generated to estimate the effect sizes of the continuous outcomes included. Studies lacking data required for meta-analysis were summarized qualitatively. RESULTS: We screened 634 studies and included 14 studies comprising 491 participants, of whom 489 had CM. Two studies were RCTs, 12 were observational uncontrolled studies, and all but one study included only youth with CM. Five Class IV observational uncontrolled studies were amenable to pooling in meta-analyses. After a mean of 2-2.6 injection cycles, headache frequency was shown to decrease significantly after treatment with onabotulinumtoxinA (Hedge's g = 0.97, 95% CI 0.58-1.35; p < 0.0001), as did severity (Hedge's g = 1.24, 95% CI 0.55-1.94; p = 0.0005), with both estimates having a large effect size magnitude. A Class I parallel-group RCT of one injection series (155 U, 74 U, or placebo), powered to detect a change in 4 headache days per month, did not find outcome differences between the active and placebo treatment arms. A Class IV crossover RCT showed superiority of active (155 U) versus placebo injections. The remaining Class IV observational studies that were excluded from the meta-analyses all showed improved outcomes with onabotulinumtoxinA injections over time. No serious adverse events related to treatment occurred. CONCLUSION: OnabotulinumtoxinA injections have established safety for use in children and adolescents with CM and are likely effective in reducing headache frequency and severity over time. However, in the absence of an adequately powered parallel-group RCT assessing the efficacy of multiple injection cycles, it remains unclear if this intervention is superior to placebo.
RESUMO
BACKGROUND: Pediatric chronic pain (i.e., pain lasting ≥ 3 months) is prevalent, disabling, and costly. It spikes in adolescence, interrupts psychosocial development and functioning, and often co-occurs with mental health problems. Chronic pain often begins spontaneously without prior injuries and/or other disorders. Prospective longitudinal cohort studies following children from early childhood, prior to chronic pain onset, are needed to examine contributing factors, such as early pain experiences and mental health. Using data from a longitudinal community pregnancy cohort (All Our Families; AOF), the present study examined the associations between early developmental risk factors, including early childhood pain experiences and mental health symptoms, and the onset of pediatric chronic pain at ages 8 and 11 years. METHODS: Available longitudinal AOF data from child age 4 months, as well as 1, 2, 3, 5, 8, and 11 years, were used. Mothers reported their child's pain experiences (e.g., hospitalizations, vaccinations, gut problems) at each timepoint from 4 months to 8 years, child chronic pain at age 8, and child mental health symptoms at ages 5 and 8 years. Children reported their chronic pain frequency and interference at age 11. Adaptive least absolute shrinkage and selection operator (LASSO) regressions were used to select predictor variables. Complete case analyses were complemented by multiple imputation using chained equation (MICE) models. RESULTS: Gut problems, emergency room visits, frequent pain complaints, and headaches at age 5 or earlier, as well as female sex, were associated with increased risk of maternal reported child chronic pain at age 8. Maternal reported chronic pain at age 8 was associated with higher levels of child-reported pain frequency and pain interferences at age 11. Boys self-reported lower levels of pain interference at age 11. CONCLUSIONS: Some, but not all, painful experiences (e.g., gut problems, ER visits, pain complaints) in early life contribute to pediatric chronic pain onset and should be considered for screening and early intervention.
Assuntos
Dor Crônica , Humanos , Dor Crônica/epidemiologia , Dor Crônica/psicologia , Dor Crônica/etiologia , Criança , Fatores de Risco , Feminino , Masculino , Estudos Longitudinais , Pré-Escolar , Lactente , Estudos ProspectivosRESUMO
OBJECTIVE: To describe the association between day-to-day peak pain severity and clinical factors in individuals with chronic migraine (CM). BACKGROUND: Little is known about how clinical factors relate to day-to-day pain severity in individuals with CM. METHODS: Adults with CM were enrolled into this observational prospective cohort study that collected daily data about headache, associated symptoms, and lifestyle factors using a digital health platform (N1-Headache™) for 90 days. "Migraine days" were defined as days in which a headache occurred that had features described by the International Classification of Headache Disorders criteria. On these days, peak pain severity was recorded on a 4-point scale; on non-headache days peak pain severity was imputed as "0/none". The associations between peak pain severity and 12 clinical factors were modeled and adjusted for sex, age, daily headache, presence of menstrual bleeding, day of the week, and disability. All numerical and Likert scale variables were standardized prior to analysis. RESULTS: Data were available for 392 participants (35,280 tracked days). The sample was predominantly female (90.6%), with a mean (standard deviation) age of 39.9 (12.8) years. In the final multivariable model with random intercept and slopes, higher than typical self-reported levels of standardized stress (odds ratio [OR] 1.07, 95% confidence interval [CI] 1.04-1.11), standardized irritability (OR 1.05, 95% CI 1.02-1.08), standardized sadness (OR 1.05, 95% CI 1.02-1.07), fatigue (OR 1.25, 95% CI 1.15-1.36), eyestrain (OR 1.38, 95% CI 1.26-1.52), neck pain (OR 1.94, 95% CI 1.76-2.13), skin sensitivity (OR 1.61, 95% CI 1.44-1.80), and dehydration (OR 1.29, 95% CI 1.18-1.42) were associated with higher reported peak pain severity levels, while standardized sleep quality (OR 0.96, 95% CI 0.93-0.99) and standardized waking feeling refreshed (OR 0.84, 95% CI 0.81-0.88) were associated with lower reported peak pain severity levels. The inclusion of a random intercept and random slopes improved upon more parsimonious models and illustrated large differences in individuals' reporting of peak severity according to the levels of the associated clinical factors. CONCLUSION: Our data showed that the experience of CM, from a pain severity perspective, is complex, related to multiple clinical variables, and highly individualized. These results suggest that future work should aim to study a personalized approach to both medical and behavioral interventions for CM based on which clinical factors relate to the individual's experience of pain severity.
Assuntos
Transtornos de Enxaqueca , Índice de Gravidade de Doença , Humanos , Feminino , Masculino , Transtornos de Enxaqueca/fisiopatologia , Adulto , Pessoa de Meia-Idade , Estudos Prospectivos , Medição da Dor , Estudos de Coortes , Diários como Assunto , Doença CrônicaRESUMO
OBJECTIVE: To describe acute and preventive treatment preferences among youth with migraine and their parents/guardians, and to describe the degree of youth-parent/guardian preference agreement. BACKGROUND: Headache disorders are common in youth, but little is known about patient and family preferences for headache treatments and outcomes. METHODS: In this cross-sectional survey, a headache treatment preferences questionnaire was co-created with stakeholders, piloted, and distributed to consenting youth with migraine aged 9-18 years and parents/guardians at a tertiary care headache clinic in western Canada. Response data were summarized for youth and parents/guardians separately, and agreement rates within a youth-parent/guardian pair were compared to a hypothesized agreement rate of 80% for the primary questionnaire items. RESULTS: Seventy-two youth and n = 94 parents/guardians participated, with n = 63 in youth-parent/guardian pairs. Freedom from pain and rapid relief, and reducing pain severity and headache frequency were top acute and preventive treatment priorities, respectively. More than 90% (69/72) agreed that ≥ 50% reduction in headache frequency was a good target. For both acute and preventive interventions, swallowed pill-based options were most often selected as the preferred first-line treatment, with neuromodulation selected as the preferred second-line treatment. The level of agreement within youth-parent/guardian pairs on preferred treatment modalities was lower than hypothesized for acute (63% [40/63], 95% confidence interval [CI] = 52-75%, χ2 = 10.73, p = 0.001) but not for preventive treatment (73% [46/63], 95% CI = 62-84%, χ2 = 1.92, p = 0.166). Regarding which treatment modalities were perceived as most effective, youth-parent agreement was lower than hypothesized for both acute (48% [30/63], 95% CI = 35-60%, χ2 = 41.29, p < 0.001) and preventive treatment (46% [29/63], 95% CI = 34-58%, χ2 = 45.43, p < 0.001). CONCLUSION: Youth and family preferences aligned qualitatively, but sometimes diverged quantitatively, from typical clinical trial outcomes. The level of agreement within youth-parent/guardian pairs on treatment preferences and perceptions was low. Clinicians should consider both perspectives as they may be divergent.
Assuntos
Preferência do Paciente , Humanos , Criança , Adolescente , Masculino , Feminino , Estudos Transversais , Pais , Inquéritos e Questionários , Transtornos de Enxaqueca/prevenção & controle , Transtornos de Enxaqueca/terapia , Cefaleia/terapia , Cefaleia/prevenção & controle , Família , CanadáRESUMO
OBJECTIVES: The primary objective of this proposed guideline is to update the prior 2016 guideline on parenteral pharmacotherapies for the management of adults with a migraine attack in the emergency department (ED). METHODS: We will conduct an updated systematic review and meta-analysis using the 2016 guideline methodology to provide clinical recommendations. The same search strategy will be used for studies up to 2023, with a new search strategy added to capture studies of nerve blocks and sphenopalatine blocks. Medline, Embase, Cochrane, clinicaltrials.gov, and the World Health Organization International Clinical Trial Registry Platform will be searched. Our inclusion criteria consist of studies involving adults with a diagnosis of migraine, utilizing medications administered intravenously, intramuscularly, or subcutaneously in a randomized controlled trial design. Two authors will perform the selection of studies based on title and abstract, followed by a full-text review. A third author will intervene in cases of disagreements. Data will be recorded in a standardized worksheet and subjected to verification. The risk of bias will be assessed using the American Academy of Neurology tool. When applicable, a meta-analysis will be conducted. The efficacy of medications will be evaluated, categorizing them as "highly likely," "likely", or "possibly effective" or "ineffective." Subsequently, clinical recommendations will be developed, considering the risk associated with the medications, following the American Academy of Neurology recommendation development process. RESULTS: The goal of this updated guideline will be to provide guidance on which injectable medications, including interventional approaches (i.e., nerve blocks, sphenopalatine ganglion), should be considered effective acute treatment for adults with migraine who present to an ED. CONCLUSIONS: The methods outlined in this protocol will be used in the design of a future systematic review and meta-analysis-informed guideline, which will then be assessed by and submitted for endorsement by the American Headache Society.
Assuntos
Serviço Hospitalar de Emergência , Transtornos de Enxaqueca , Humanos , Transtornos de Enxaqueca/tratamento farmacológico , Serviço Hospitalar de Emergência/normas , Revisões Sistemáticas como Assunto , Adulto , Sociedades Médicas/normas , Guias de Prática Clínica como Assunto/normas , Metanálise como AssuntoRESUMO
ABSTRACT: In patients with migraine, an excitation-inhibition imbalance that fluctuates relative to attack onset has been proposed to contribute to the underlying pathophysiology of migraine, but this has yet to be explored in children and adolescents. This prospective, observational, cohort study examined glutamate and gamma-aminobutyric acid (GABA) levels across the phases of a migraine attack and interictally in children and adolescents using magnetic resonance spectroscopy. Macromolecule-suppressed GABA (sensorimotor cortex and thalamus) and glutamate (occipital cortex, sensorimotor cortex, and thalamus) were measured in children and adolescents (10-17 years) with a migraine diagnosis with or without aura 4 times over 2 weeks. Linear mixed-effects models examined changes in glutamate and GABA during the 72 hours leading up to, and after the onset of an attack. We found significant region-specific changes in glutamate and GABA. Specifically, sensorimotor GABA significantly increased leading up to the headache phase, whereas glutamate significantly decreased following the headache onset in the occipital cortex and the thalamus. Post hoc analyses examined the 24 hours leading up to or following the onset of the headache phase. In the 24 hours before the headache onset, sensorimotor glutamate, occipital glutamate, and thalamic GABA decreased. In the 24 hours post headache onset, sensorimotor glutamate continued to decrease. Our results suggest changes in glutamate and GABA that are consistent with the thalamocortical dysrhythmia hypothesis. These findings provide insight into developmental migraine pathophysiology and may open future avenues for treatment targets specific to children and adolescents.
RESUMO
Chronic pain and posttraumatic stress disorder symptoms (PTSS) co-occur at high rates in youth and are linked to worse pain outcomes and quality of life. While peer victimization has been posited as a mechanism underlying the PTSS-pain relationship in youth, empirical evidence suggests that it may exacerbate both PTSS and pain. The present study aimed to longitudinally examine PTSS as a mediator in the relationship between peer victimization at baseline and pain-related outcomes at 3 months in youth with chronic pain. Participants included 182 youth aged 10 to 18 years recruited from a tertiary-level children's hospital in Western Canada. At baseline, participants completed measures to assess pain (intensity and interference), peer victimization (relational and overt), and PTSS. The pain was reassessed at a 3-month follow-up. Primary hypotheses were tested utilizing a series of mediation analyses with PTSS as a proposed mediator in the associations between peer victimization and pain outcomes. Youth PTSS mediated the relationship between higher baseline relational victimization and higher 3-month pain interference while controlling for baseline pain interference. Three-month pain intensity was not correlated with peer victimization; thus, pain intensity was not included in the analyses. These findings reveal that PTSS may be an underlying factor in the co-occurrence of peer victimization and chronic pain in youth. Further research is needed to better understand the role of peer victimization in the maintenance of chronic pain to ensure appropriate, effective, and timely interventions that address the social and mental health issues impacting the lives of these youth as well as their pain. PERSPECTIVE: PTSS may be an underlying factor in the co-occurrence between peer victimization and chronic pain in youth, highlighting the need to assess for both peer relationship problems and PTSS in youth with chronic pain.
Assuntos
Bullying , Dor Crônica , Vítimas de Crime , Grupo Associado , Transtornos de Estresse Pós-Traumáticos , Humanos , Dor Crônica/psicologia , Dor Crônica/fisiopatologia , Transtornos de Estresse Pós-Traumáticos/fisiopatologia , Adolescente , Masculino , Feminino , Criança , Estudos Longitudinais , Vítimas de Crime/psicologiaRESUMO
OBJECTIVE: The objective of this study was to explore the longitudinal relationship between anxiety and depressive symptoms and migraine outcomes in children and adolescents. BACKGROUND: Children and adolescents with migraine experience more anxiety and depressive symptoms than their peers without migraine, but it is unknown if these symptoms are associated with differential migraine outcomes. METHODS: In this prospective clinical cohort study, children and adolescents aged 8.0-18.0 years with migraine completed headache questionnaires and validated measures of anxiety and depressive symptoms (Patient-Reported Outcomes Measurement Information System) at an initial consultation and at their first follow-up visit with a neurologist. Changes in monthly headache frequency and changes in migraine-related disability (Pediatric Migraine Disability Assessment) were tracked at each time point. The relationships between these migraine outcomes and anxiety and depressive symptoms were estimated using models controlling for sex, age, headache frequency, and treatment type. RESULTS: There were 123 consenting participants. In models adjusted for age, sex, baseline disability score, and treatment type, baseline anxiety and depressive symptom levels were not significantly associated with change in headache frequency (for anxiety symptoms: ß = -0.05, 95% confidence interval [CI] = -0.268 to 0.166, p = 0.639; for depressive symptoms: ß = 0.14, 95% CI = -0.079 to 0.359, p = 0.209). Similarly, in models adjusted for age, sex, baseline headache frequency, and treatment type, the change in disability was not associated with baseline anxiety (ß = -0.45, 95% CI = -1.69 to 0.78, p = 0.470), nor with baseline depressive symptom scores (ß = 0.16, 95% CI = -1.07 to 1.40, p = 0.796). In post hoc exploratory analyses (N = 84 with anxiety and N = 82 with depressive symptom data at both visits), there were also no significant associations between change in mental health symptoms and change in headache frequency (for anxiety symptoms: ß = -0.084, 95% CI = -0.246 to 0.078, p = 0.306; for depressive symptoms: ß = -0.013, 95% CI = -0.164 to 0.138, p = 0.865). Similarly, the change in disability scores between visits was not related to the change in anxiety (ß = 0.85, 95% CI = -0.095 to 1.78, p = 0.077) nor depressive symptom scores (ß = 0.32, 95% CI = -0.51 to 1.15, p = 0.446). CONCLUSION: Baseline anxiety and depressive symptom levels were not associated with longitudinal migraine outcomes and neither were longitudinal changes in anxiety and depressive symptom levels; this contradicts popular clinical belief that mental health symptoms predict or consistently change in tandem with migraine outcomes.
Assuntos
Ansiedade , Depressão , Transtornos de Enxaqueca , Humanos , Transtornos de Enxaqueca/psicologia , Adolescente , Masculino , Feminino , Criança , Ansiedade/etiologia , Estudos Prospectivos , Estudos LongitudinaisRESUMO
OBJECTIVE: This article reviews the assessment of children and adolescents presenting with headache, provides an overview of primary headache disorders, and reviews evidence-based management of headache in this age group. LATEST DEVELOPMENTS: In the last few years, new epidemiological data have shed light on less common pediatric headache disorders (eg, pediatric trigeminal autonomic cephalalgias) and psychosocial risk factors associated with primary headache disorders in children and adolescents. There has also recently been a substantial increase in interventions that target the calcitonin gene-related peptide pathway and that treat primary headache disorders using noninvasive neuromodulation. Although these interventions have primarily been studied in adults, there is emerging evidence of their use in the pediatric population. ESSENTIAL POINTS: Primary headache disorders are very common in youth, and the most commonly encountered headache diagnosis in neurology practice is migraine, which affects approximately 10% of children and adolescents. Diagnosing and effectively treating primary headache disorders before adulthood may have a sustained impact on the patient by improving long-term headache and mental health outcomes, thereby significantly reducing the burden of disability over time. There are several available and emerging acute and preventive interventions for youth with primary headache disorders, and treatment decisions should be made in the context of available evidence using a shared decision-making approach.
Assuntos
Transtornos da Cefaleia , Transtornos de Enxaqueca , Cefalalgias Autonômicas do Trigêmeo , Adolescente , Criança , Humanos , Cefaleia/diagnóstico , Cefaleia/epidemiologia , Cefaleia/terapia , Fatores de RiscoRESUMO
Parents with (vs without) chronic pain report poorer psychosocial functioning (eg, worse mental health, parenting difficulties), which has been linked to poorer child outcomes (eg, child pain). However, emerging research suggests that individuals vary in their functioning from day-to-day, particularly those with chronic pain. This study used daily diaries to compare parents with (versus without) chronic pain on variability in their anxiety, mood, protective responses, and parenting stress. We also examined parent chronic pain status as a moderator of the associations between parent variability and youth daily pain and interference. Participants were 76 youth with chronic pain (Mage = 14.26; 71.1% female) and one of their parents (89.5% mothers; n = 38 or 50.0% endorsing chronic pain). Parents and youth completed self-report questionnaires and 7 days of diaries. Parent variability was calculated to reflect the frequency and size of day-to-day changes. Multilevel models revealed that parents with (vs without) chronic pain were significantly more variable in their parenting stress, but not in their anxiety, mood, or protective responses. Contrary to hypotheses, parent variability was not significantly related to youth daily pain intensity or interference and parent chronic pain did not moderate any associations. Instead, mean levels of parent anxiety, protective responses, and parenting stress across the week significantly predicted youth daily pain interference. Findings suggest that while variability was observed among parents (with and without chronic pain) of youth with chronic pain, it did not significantly predict youth's daily pain-related functioning. Further research is needed to confirm these initial findings. PERSPECTIVE: Parents with chronic pain have expressed concerns that the variable nature of their pain negatively impacts their children. Our results found that parents (with and without chronic pain) were variable in their anxiety, mood, protective responses, and parenting stress, but this variability did not significantly predict youth's chronic pain-related functioning.
Assuntos
Ansiedade , Dor Crônica , Depressão , Poder Familiar , Pais , Estresse Psicológico , Humanos , Feminino , Masculino , Dor Crônica/psicologia , Estresse Psicológico/psicologia , Poder Familiar/psicologia , Adolescente , Pais/psicologia , Adulto , Criança , Relações Pais-Filho , Filho de Pais com Deficiência/psicologia , Pessoa de Meia-IdadeRESUMO
BACKGROUND AND OBJECTIVES: Lifestyle behaviors have been postulated to affect headache frequency in youth and are often the primary target of self-management recommendations. Our study aimed to assess the association between various lifestyle factors and frequent recurrent headaches in children and youth. METHODS: Children and adolescents aged 5-17 years were enrolled in a large cross-sectional Canadian population-based health survey, completed on January 31, 2019. Headache frequency was dichotomized into "approximately once/week or less" or ">once/week" (defined as frequent recurrent headaches). The association between frequent headaches and meal schedules, screen exposure, physical activity, chronotype, and frequent substance use/exposure (alcohol, cigarettes, electronic cigarettes, and cannabis) was assessed using both unadjusted logistic regression models and models adjusted for age/sex. Fully adjusted models examined the odds of frequent headaches according to all exposures. Survey design effects were accounted for using bootstrap replicate weighting. RESULTS: There were an estimated nweighted = 4,978,370 eligible participants in the population. The mean age was 10.9 years (95% CI 10.9-11.0); 48.8% were female; 6.1% had frequent headaches. Frequent headaches were associated with older age (odds ratio [OR] = 1.31, 95% CI 1.28-1.34, p < 0.001) and female sex (OR = 2.39, 95% CI 2.08-2.75, p < 0.001). In models adjusted for age/sex, the odds of frequent headaches decreased with meal regularity (adjusted OR [aOR] = 0.90, 95% CI 0.89-0.92, p < 0.001) and increased with later chronotype (aOR = 1.10, 95% CI 1.05-1.15, p < 0.001) and excess screen exposure (≥21 hours vs none in past week: aOR = 2.97, 95% CI 1.53-5.77, p = 0.001); there was no significant association with reported physical activity (aOR = 0.95, 95% CI 0.67-1.34, p = 0.77). In 12- to 17-year-olds, frequent headaches were associated with frequent alcohol use (≥1/wk vs never: aOR = 3.50, 95% CI 2.18-5.62, p < 0.001), binge drinking (≥5 times in past month vs never: aOR = 5.52, 95% CI 2.95-10.32, p < 0.001), smoking cigarettes (daily vs never: aOR = 3.81, 95% CI 1.91-7.62, p < 0.001), using e-cigarettes (daily vs never: aOR = 3.10, 95% CI 2.29-4.20, p < 0.001), and cannabis use (daily vs never: aOR = 3.59, 95% CI 2.0-6.45, p < 0.001). In the entire sample, daily exposure to smoking inside the house was associated with frequent headaches (aOR = 2.00, 95% CI 1.23-3.27, p = 0.005). DISCUSSION: Several lifestyle behaviors were associated with frequent headaches in children and youth, such as meal irregularity, late chronotype, prolonged screen exposure, and frequent substance use/exposure, suggesting that these are potential modifiable risk factors to target in this population.
Assuntos
Sistemas Eletrônicos de Liberação de Nicotina , Transtornos Relacionados ao Uso de Substâncias , Criança , Humanos , Adolescente , Feminino , Masculino , Estudos Transversais , Canadá/epidemiologia , Cefaleia/epidemiologia , Estilo de VidaRESUMO
ABSTRACT: Mental health problems are common among parents of children with chronic pain and associated with worse outcomes for the child with chronic pain. However, the effect sizes of these associations between parent mental health and pediatric chronic pain vary widely across studies. The aim of this systematic review and meta-analysis was to generate pooled estimates of the (1) prevalence of mental health problems among parents of children with chronic pain and (2) associations between parent mental health and the (2a) presence of child chronic pain and (2b) functioning of children with chronic pain. Embase, MEDLINE, PsycINFO, Web of Science, and CINAHL were searched up to November 2022. Observational studies that examined symptoms or diagnoses of parent anxiety, depression, or general distress and the presence of child chronic pain and/or related functioning were included. From 32,848 records, 2 coders identified 49 studies to include in random-effects meta-analyses. The results revealed that mental health problems among parents of children with chronic pain were common (anxiety: 28.8% [95% CI 20.3-39.1]; depression: 20.0% [15.7-25.2]; general distress: 32.4% [22.7-44.0]). Poorer parent mental health was significantly associated with the presence of chronic pain (anxiety: OR = 1.91 [1.51-2.41]; depression: OR = 1.90 [1.51-2.38]; general distress: OR = 1.74 [1.47-2.05]) and worse related functioning (ie, pain intensity, physical functioning, anxiety and depression symptoms; r s = 0.10-0.25, all P s < 0.05) in children. Moderator analyses were generally nonsignificant or could not be conducted because of insufficient data. Findings support the importance of addressing parent mental health in the prevention and treatment of pediatric chronic pain.
Assuntos
Dor Crônica , Saúde Mental , Pais , Humanos , Dor Crônica/psicologia , Dor Crônica/epidemiologia , Pais/psicologia , Criança , Ansiedade/epidemiologia , Ansiedade/psicologia , Depressão/epidemiologia , Depressão/psicologia , AdolescenteRESUMO
Youth have a right to participate in research that will inform the care that they receive. Engagement with children and young people has been shown to improve rates of enrollment and retention in clinical trials as well as reduce research waste. The aim of the study is to gain practical insight on the design of trials specifically on (1) recruitment and retention preferences, (2) potential barriers to research, and (3) study design optimization. Based on this youth engagement, we will co-design two clinical trials in headaches with youth. Two recruitment strategies were used to recruit 16 youth from across Canada (aged 15-18 years) from an existing youth group, the KidsCan Young Persons' Research Advisory Group (YPRAG) and a new youth group in collaboration with Solutions for Kids in Pain (SKIP). Four virtual, semi-structured discussion groups were held between April and December 2020, which included pre-circulated materials and utilized two distinct upcoming planned trials as examples for specific methods feedback. Individual engagement evaluations were completed following the final group session using the Public and Patient Engagement Evaluation Tool. Descriptive results were shared with participants prior to publication to ensure appropriate interpretation. The discussion was centred around three themes: recruitment and retention preferences, potential barriers to participation, and study design optimization. Youth indicated that they would prefer to be contacted for a potential study directly by their physician (not over social media), that they would like to develop rapport with study staff, and that one of the barriers to participation is the time commitment. The youth also provided feedback on the design of the clinical trial including outcome measurement tools, data collection, and engagement methods. Feedback on the virtual format of the engagement events indicated that participants appreciated the ease of the online discussion and that the open-ended discussion allowed for easy exchange of ideas. They felt that despite a gender imbalance (towards females) it was an overall inclusive environment. All participants reported believing that their engagement will make a difference to the work of the research team in designing the clinical trials. Perspectives from a diverse group of youth meaningfully improved the design and conduct of two clinical trials for headaches in children. This study provides a framework for future researchers to engage youth in the co-design of clinical trials using online engagement sessions.
RESUMO
OBJECTIVE: To characterize the direct impact of monthly headache days (MHDs) on health-related quality of life (HRQoL) in people with migraine and the potential mediating effects of anxiety, depression, and allodynia. BACKGROUND: Although the general relationship between increased migraine frequency (i.e., MHDs) and reduced HRQoL is well established, the degree to which reduced HRQoL is due to a direct effect of increased MHDs or attributable to mediating factors remains uncertain. METHODS: Cross-sectional baseline data from participants with migraine who completed the Core and Comorbidities/Endophenotypes modules in the 2012-2013 US Chronic Migraine Epidemiology and Outcomes (CaMEO) study, a longitudinal web-based survey study, were analyzed. The potential contribution of depression, anxiety, and/or allodynia to the observed effects of MHDs on HRQoL as measured by the Migraine-Specific Quality-of-Life Questionnaire version 2.1 (MSQ) was evaluated. RESULTS: A total of 12,715 respondents were included in the analyses. The MSQ domain scores demonstrated progressive declines with increasing MHD categories (B = -1.23 to -0.60; p < 0.001). The observed HRQoL decrements associated with increasing MHDs were partially mediated by the presence of depression, anxiety, and allodynia. The MHD values predicted 24.0%-32.4% of the observed variation in the MSQ domains. Depression mediated 15.2%-24.3%, allodynia mediated 9.6%-16.1%, and anxiety mediated 2.3%-6.0% of the observed MHD effects on the MSQ. CONCLUSIONS: Increased MHD values were associated with lower MSQ scores; the impact of MHDs on the MSQ domain scores was partially mediated by the presence of depression, anxiety, and allodynia. MHDs remain the predominant driver of the MSQ variation; moreover, most of the variation in the MSQ remains unexplained by the variables we analyzed. Future longitudinal analyses and studies may help clarify the contribution of MHDs, comorbidities, and other factors to changes in HRQoL.
Assuntos
Transtornos de Enxaqueca , Qualidade de Vida , Humanos , Estudos Transversais , Hiperalgesia , Resultado do Tratamento , Transtornos de Enxaqueca/epidemiologia , CefaleiaRESUMO
Migraine is common in children and adolescents and can cause significant disability. There are relatively limited evidence-based treatment options available, especially when compared with treatment of migraine in adults. The Pediatric Research Equity Act requires the study of a new drug or biologic in pediatric populations. As such it is mandatory that the newest migraine treatment options available for adults be evaluated in children and adolescents. It will take years before results from clinical trials in pediatric patients become available. In the meantime, there is eagerness among clinicians to seek out the existing evidence that may help provide clarity on utilization of the newer migraine therapies in children and adolescents because many of the currently available, guideline-recommended treatments do not provide benefit for all patients. In this narrative review, the literature regarding onabotulinumtoxinA, neuromodulatory devices, calcitonin gene-related peptide (CGRP) monoclonal antibodies, 5-hydroxytryptamine (1F) agonists (i.e., ditans), and CGRP small-molecule receptor antagonists (i.e., gepants) for the treatment of migraine in children and adolescents will be summarized.
Assuntos
Peptídeo Relacionado com Gene de Calcitonina , Transtornos de Enxaqueca , Humanos , Adolescente , Criança , Peptídeo Relacionado com Gene de Calcitonina/uso terapêutico , Transtornos de Enxaqueca/tratamento farmacológico , Antagonistas do Receptor do Peptídeo Relacionado ao Gene de Calcitonina/uso terapêutico , Receptores de Peptídeo Relacionado com o Gene de Calcitonina , Anticorpos Monoclonais/uso terapêuticoRESUMO
BACKGROUND AND OBJECTIVES: It is unknown whether bullying and gender diversity are associated with increased headache frequency in adolescents. Our study aimed to assess the association between peer victimization, gender diversity, and frequent recurrent headaches in adolescents, while controlling for age, sex, socioeconomic status, and potential confounders (mood and anxiety disorders, suicidality). METHODS: This was a cross-sectional observational study of adolescents aged 12-17 years using data from a Canadian population-based health survey. Headache frequency was dichotomized into "≤once/wk" or ">once/wk" (i.e., frequent recurrent headaches). Logistic regression was used to quantify the association between frequent peer victimization (overt or relational), gender diversity (female sex at birth + male gender, male sex at birth + female gender, or gender diverse), mood/anxiety disorder, suicidality, and the odds of frequent recurrent headaches. The fully adjusted multivariable logistic regression model included all exposures and was controlled for age, sex, and socioeconomic status. Bootstrap replicate weighting was used to account for survey design effects. RESULTS: There were an estimated 2,268,840 eligible participants (weighted sample size) (mean age = 14.4 years, 48.8% female, 0.5% gender diverse), and 11.2% reported frequent recurrent headaches. Frequent recurrent headaches were associated with older age (odds ratio [OR] = 1.26 per year of age, 95% CI 1.20-1.31), female sex (OR = 2.89, 95% CI 2.47-3.37), and being gender diverse (OR = 3.30, 95% CI 1.64-6.63, adjusted for age/sex). Youth with frequent headaches had higher odds of experiencing both overt and relational bullying compared with peers (OR = 2.69, 95% CI 2.31-3.14, and OR = 3.03, 95% CI 2.58-3.54, adjusted for age/sex). In the fully adjusted model, frequent headaches were no longer associated with gender diversity (OR = 1.53, 95% CI 0.63-3.69) but were still associated with frequent overt and relational peer victimization (OR = 1.82, 95% CI 1.41-2.34, and OR = 1.54, 95% CI 1.17-2.03, respectively), suicidality (OR = 1.83, 95% CI 1.44-2.32), and having a mood or anxiety disorder (OR = 1.50, 95% CI 1.01-2.21, and OR = 1.74, 95% CI 1.24-2.45, respectively). In a model adjusted for age, sex, and mood/anxiety disorders, the risk of suicidality increased incrementally with headache frequency. DISCUSSION: Peer victimization and suicidality may be associated with higher headache frequency in adolescents with headaches, independently of mood and anxiety symptoms. Gender-diverse adolescents may have a higher risk of experiencing frequent headaches when compared with cisgender peers, and this may be explained by associated psychosocial factors (anxiety, depression, suicidality, and peer victimization).
Assuntos
Bullying , Vítimas de Crime , Recém-Nascido , Humanos , Masculino , Adolescente , Feminino , Saúde Mental , Estudos Transversais , Canadá/epidemiologia , Inquéritos e Questionários , Cefaleia , Bullying/psicologia , Vítimas de Crime/psicologiaRESUMO
Migraine is a leading cause of disability worldwide, and acute migraine attacks are a common reason for patients to seek care in the emergency department (ED). There have been recent advancements in the care of patients with migraine, specifically emerging evidence for nerve blocks and new pharmacological classes of medications like gepants and ditans. This article serves as a comprehensive review of migraine in the ED, including diagnosis and management of acute complications of migraine (eg, status migrainosus, migrainous infarct, persistent aura without infarction, and aura-triggered seizure) and use of evidence-based migraine-specific treatments in the ED. It highlights the role of migraine preventive medications and provides a framework for emergency physicians to prescribe them to eligible patients. Finally, it evaluates the evidence for nerve blocks in the treatment of migraine and introduces the possible role of gepants and ditans in the care of patients with migraine in the ED.
Assuntos
Epilepsia , Transtornos de Enxaqueca , Humanos , Transtornos de Enxaqueca/prevenção & controle , Serviço Hospitalar de Emergência , Convulsões , Epilepsia/complicaçõesRESUMO
BACKGROUND AND OBJECTIVE: To assess the characteristics and extent of variation of the endpoints used in trials supporting the US Food and Drug Administration (FDA) approval of medications treating migraine. METHODS: Using the Drugs@FDA online database, we identified novel prescription medications approved by the FDA between January 2001 and September 2022, for migraine with or without aura, for both acute and preventive treatment, and for episodic and chronic presentations. For each medication, we used the most recent FDA-approved labeling to identify indication, mechanism of action, mode of administration, manufacturer, approval year, number of pivotal trials, trial design, and primary endpoints. RESULTS: Sixteen FDA-approved medications for the acute or preventive treatment of migraine were supported by 45 pivotal trials. There were 5 primary endpoint types: (1) change in mean monthly migraine days from baseline; (2) change in mean monthly migraine attacks from baseline; (3) change in mean monthly headache days from baseline; (4) mild to no pain After 2 hours; (5) pain free at 2 hours. There were 3 combinations of coprimary endpoints: (1) Headache Pain Free at 2 Hours and Most Bothersome Symptom Free at 2 Hours; (2) Pain Free at 2 Hours and Sustained Pain Free from 2-24 Hours Postdose; (3) Pain Free at 2 Hours and 2-24 Hours Sustained Pain Free and 2-Hour Pain Relief. Of the 8 preventive migraine medications, the timing of endpoint measurement included the full double-blind period, segments of the double-blind period, and the final month of the double-blind period. DISCUSSION: Migraine medication trial endpoints were inconsistent within the same indication (episodic or chronic), mechanistic class, and route of administration, frustrating direct comparison among these medications. Furthermore, inconsistent definitions for the indications "episodic" and "chronic" migraine were also observed. Consistent endpoint selection for medications approved for preventive and acute migraine treatment would enhance the ability of patients, physicians, and payers to make informed choices among these medications.