Objective: To determine the tolerability and safety of concurrent peripheral nerve blocks and onabotulinumtoxinA treatment during a single outpatient clinic procedure visit. BackgroundProcedural interventions are available for the treatment of headache disorders. OnabotulinumtoxinA and peripheral nerve blocks are used as alternatives or in addition to oral therapies to reduce the frequency and intensity of migraine attacks. There is currently a lack of safety data focusing on the sequential administration of local anesthetic via peripheral nerve blocks and onabotulinumtoxinA during a single clinical encounter for the treatment of headache. The primary aim of the study was to determine the safety and tolerability of concurrent peripheral nerve blockade and onabotulinumtoxinA injections during a single outpatient clinic procedure visit. We hypothesized that the dual intervention would be safe and well tolerated by patients with chronic migraine and other headache disorders. Methods: A retrospective chart review was performed using clinical data from patients seen by multiple providers over a 16-month timeframe at one outpatient headache clinic. Patients were identified by procedure codes and those receiving peripheral nerve block(s) and onabotulinumtoxinA injections during a single encounter within the study period were eligible for inclusion. Inclusion criteria were (1) patients 18 years and older who were (2) receiving both peripheral nerve blocks and onabotulinumtoxinA injections for the treatment of chronic migraine. Patients were excluded if they were under age 18, received their procedure outside of the clinic (emergency room, inpatient ward), or were receiving sphenopalatine ganglion blocks. Age- and sex-matched patients who received one procedure, either peripheral nerve blocks or onabotulinumtoxinA, were used for control. The primary outcome of this safety study was the number of adverse events that occurred in the dual intervention group compared to the single intervention control arms. Information regarding adverse events was gathered via retrospective chart review. If an adverse event was recorded, it was then graded by the reviewer utilizing the Common Terminology Criteria for Adverse Events ranging from Grade 1 Mild Event to Grade 5 Death. Additionally, it was noted whether the adverse event led to treatment discontinuation. Results: In total, 375 patients were considered eligible for inclusion in the study. After age and sex matching of controls, 131 patients receiving dual intervention were able to be compared to 131 patients receiving onabotulinumtoxinA alone and 104 patients receiving dual intervention were able to be compared to 104 patients receiving peripheral nerve block(s) alone. The primary endpoint analysis showed no significant difference in total adverse events between dual intervention compared to nerve blocks alone or onabotulinumtoxinA alone. The number of adverse events that led to treatment discontinuation approached but did not reach statistical significance for those receiving dual intervention versus onabotulinumtoxinA alone in the number of adverse events that led to treatment termination (4.6%, 6/131 vs. 0.8%, 1/131, p = 0.065); however, the number of patients who discontinued therapy was not significantly different between those groups (2.3%, 3/131 vs. 0.8%, 1/131; p = 0.314; odds ratio 0.3 [0-3.2]; p = 0.338). Conclusions: In this retrospective chart review, there was no significant difference in adverse events or therapy discontinuation between patients receiving sequential peripheral nerve block(s) and onabotulinumtoxinA injections versus those receiving either peripheral nerve block(s) or onabotulinumtoxinA injections alone. As a result, we concluded that the combination procedure is likely safe and well tolerated in routine clinical practice.
Objective: To apply the 2019 joint American Academy of Neurology (AAN) and American Headache Society (AHS) quality measures for headache management to a cohort of neurology resident physicians and then assess outcomes related to guideline adherence. Background: The optimization of headache management is essential to reduce both the individual and systemic impact of these disorders. In 2014, the AAN developed 10 quality measures for evidence-based management of patients with headache. A workgroup updated and condensed its headache quality measures in 2019, narrowing the set to six measurements, four of which would primarily focus on the management of migraine and two of which would address the management of cluster headache. Methods: This quality improvement study was conducted using a pretest-posttest study design. A pre-intervention survey based on retrospective analysis of five clinic notes for adherence to the measures was designed and distributed to all neurology residents (n = 32) at a large, academic tertiary referral center. The intervention included the creation of an electronic medical record template to aid residents in following the measures during clinical encounters, as well as the provision of direct feedback based on pre-intervention results. Finally, a post-intervention survey was distributed for completion based on notes written during the intervention period. Analysis was limited to migraine, given the low percentage of cluster headache seen in clinic. Results: An increase in adherence was seen in three of the four migraine-related quality measures, with the Use of Abortive Medications for Migraine and Documentation of Counseling on Modifiable Lifestyle and Chronification Factors demonstrating statistically significant improvements (75.8% to 88.0% [p = 0.013] and 83.9% to 94.0% [p = 0.029] adherence, respectively). For secondary outcomes, the increase in the utilization of appropriate diagnostic criteria (82.6% to 93.2%, p = 0.018) was significant, and the self-assessed confidence rating for adherence to guidelines was significant (p < 0.001). Conclusions: This study provides evidence that the quality improvement intervention led to increased adherence to the AAN and AHS migraine-related measures. It is anticipated that increased adherence may lead to improved patient outcomes. Plain Language Summary: In 2019, the American Academy of Neurology and the American Headache Society worked together to create a set of quality measures to guide clinicians in the care of patients with headache; however, we do not know if these guidelines are being followed. This study aimed to see if resident neurologists at a large academic medical center would better follow these guidelines if they were part of a standardized electronic medical record template. Overall, this study showed that applying the headache quality measures in a real clinical setting is feasible and can improve best-care practices.
Migraine is a common neurological disorder that is present in a large proportion of the global population. It is estimated to occur in around 20.7% of women and 10.7% of men in the United States. The pathophysiology of migraine is a major focus of research, and medications have been developed to interrupt the processes that generate headache and other bothersome symptoms of migraine attacks. The triptan class of medications acts as a direct agonist at the 5-HT1B/D receptor but its use is limited by contraindications for those with coronary or cerebrovascular disease. Lasmiditan is a first-in-class agonist at the 5-HT1F serotonin receptor that does not appear to generate vasoconstriction. This article reviews the design, development, and place in therapy for lasmiditan. A narrative review of the literature using the Ovid MEDLINE database was performed. The rationale behind the development of lasmiditan and pre-clinical, proof-of-concept, Phase II, pivotal, Phase III trials and post-hoc data is covered. Additionally, the efficacy and safety of lasmiditan when compared to other acute treatments in migraine is described, including lasmiditan's side effect profile and status as a Schedule V substance. Further, head-to-head studies of lasmiditan compared with other acute treatments are required.
OBJECTIVES:To determine concordance between an explicit protocolized assessment of the Richmond Agitation-Sedation Scale and an assessment performed during usual care nursing practice.RESEARCH DESIGN:In an urban, safety-net hospital, intensive care nurses previously trained in sedation assessment recorded a bedside Richmond Agitation-Sedation Scale assessment, while study investigators used an explicit script to perform the assessment at a similar time point. Kappa indices determined concordance of the assessments. Bivariate analyses explored factors associated with discordance and unresponsiveness.RESULTS:Twenty-one subjects with 38 observations were analysed. Bedside nursing assessment was poorly concordant with protocolized assessment (ƙ = 0.21) with the former reporting significantly lighter sedation (median -2 vs. -5, p = .01). Bedside assessment was significantly less likely than protocolized assessment to categorize subjects as unresponsive (29 vs. 50%, p = .02).CONCLUSION:Methods used in usual clinical practice to assess adequacy of sedation frequently led to oversedation. We propose that care erosion, the deterioration of skills over time, may help explain this finding.IMPLICATIONS FOR NURSING MANAGEMENT:Results suggest sedation assessment may be particularly vulnerable to care erosion. Nurse managers should monitor for signs of care erosion and consider utilization of explicit scripts during sedation assessment and/or frequent education to ensure sedation assessment accuracy.
BackgroundOnabotulinumtoxinA (BTX) has become a mainstream treatment for chronic migraine (CM). Patients often have varied expectations for treatment success but little is known about how these initial impressions influence continuation of therapy.ObjectiveTo record expectations of benefit and procedural discomfort (PD) from initial BTX treatment and to investigate their association with treatment success, defined as continuation of treatment for >3 sessions within a 2‐year period.MethodsA retrospective chart review of CM patients receiving initial treatment with BTX was performed. Patients were questioned about their expectations of benefit and PD as rated on a 0‐10 scale. Responses were then compared with continuation of therapy beyond 3 sessions to identify the presence of significant association.ResultsResponses from patients (N = 297) were analyzed. About 173 subjects continued with BTX therapy for more than 3 sessions (173/297, 58.3%). Unadjusted odds ratios (OR) for expectation of benefit (EOB) (OR 1.11, 95% CI 0.99‐1.24, P = .087) and PD (OR 1.02, 95% CI 0.90‐1.16, P = .780) were not significantly predictive of continuing treatment. After considering sex, age, year of treatment, and previous headache preventative trials, only female sex (OR 2.02, 95% CI 1.09‐3.74, P = .025) was found to be significantly associated with treatment continuation.ConclusionsIn the usual care setting, PD and EOB are not significantly associated with therapy continuation in patients receiving initial treatment with BTX for the prevention of CM. However, after considering sex, age, year of treatment, and number of previous headache preventives attempted, we found that female patients had twice the likelihood of continuing with BTX therapy compared to male patients with CM.