"Identification of Essential Assessment Criteria in Facial Botulinum Toxin Injections".

INTRODUCTION: Facial botulinum toxin injections represent the most commonly performed aesthetic non-surgical procedures by plastic surgeons; however, post-graduate programs remain devoid of objective tools to adequately assess competence in trainees. In this study, the authors employ the Delphi methodology to establish a list of essential assessment criteria in facial botulinum toxin injections. METHODS: A list of 10 suggested criteria was generated through a literature search and in consultation with an expert plastic surgeon. A panel of content experts was selected to which an online survey was administered; skills were ranked for their relevance using a 1-10 Likert scale. Recommendations for additional skills were solicited and survey rounds were repeated until consensus was achieved. The latter was a measure of panelist reliability and assessed using Cronbach α (≥0.8); skills with a rating of 7 or above were taken to be essential. RESULTS: The survey process was successful at achieving consensus following two rounds of survey administration. Twenty-one participants completed the first round representing a response rate of 38%. Percent agreement among the panel was 83% and Cronbach α was computed as 0.78, necessitating further rounds. The response rate in the second round was 90%; one additional skill was added; percent agreement and Cronbach α improved to 88% and 0.87, respectively. CONCLUSION: Nine assessment criteria were identified as essential in facial botulinum toxin injections; these findings provide the groundwork necessary for the development of an objective assessment tool for the more appropriate training of marginalized aesthetic procedures in plastic surgery.

Short-term Results of Platelet-Rich Plasma in the Treatment of Chronic Anal Fissure: Randomized Controlled Clinical Study.

BACKGROUND: Anal fissure is one of the most common benign anal disorders, and medical treatments play an important role in its management. OBJECTIVE: The purpose of this study was to investigate the short-term effects and success of platelet-rich plasma in the treatment of chronic anal fissure. DESIGN: The study is a 2 parallel group, randomized, controlled clinical trial. SETTINGS: The study was performed in 2 tertiary university hospitals. PATIENTS: Forty-four patients with chronic anal fissure were randomly assigned to platelet-rich plasma treatment or control group. Presenting symptoms and pain scores were recorded on enrollment. The control patient self-administered topical glyceryl trinitrate. Platelet-rich plasma was injected locally in the intervention group followed by self-administered glyceryl trinitrate. MAIN OUTCOME MEASURES: The primary outcome measure is a reduction in pain scores. RESULTS: On day 10 and 1 month after treatment, the mean pain score was significantly lower in the patients treated with platelet-rich plasma than in the controls (p = 0.005 and p < 0.005). By 1 month after treatment, the mean pain score declined by 5.7 points in the platelet-rich plasma-treated group compared with a 4.1 mean pain score decline in the control group (mean difference:1.6 points (95% CI, 0.3-2.9)). According to the repeated-measures analyses, pain scores decreased in both groups, but the decrease in the treatment group was statistically higher than in the control group (p < 0.001). Complete epithelialization and recovery rates were significantly higher in the platelet-rich plasma group than in controls at all follow-up times, with p values ranging from 0.034 to <0.001. The observed difference in complete epithelialization after 2 months of treatment between the platelet-rich plasma group and the control group was 56.2% with a 95% CI of 14.03% to 98.4%. LIMITATIONS: This study was limited by its small sample size, and long-term follow-up of the patients was not presented. CONCLUSIONS: Platelet-rich plasma reduced concerns and accelerated epithelialization and healing in patients with chronic anal fissures. See Video Abstract at http://links.lww.com/DCR/B461.RESULTADOS A CORTO PLAZO DEL PLASMA RICO EN PLAQUETAS EN EL TRATAMIENTO DE LA FISURA ANAL CRÓNICA: ESTUDIO CLÍNICO CONTROLADO ALEATORIZADO. ANTECEDENTES: La fisura anal es uno de los trastornos anales benignos más comunes y los tratamientos médicos juegan un papel importante en su manejo. OBJETIVO: El propósito de este estudio fue investigar los efectos a corto plazo y el éxito del plasma rico en plaquetas en el tratamiento de la fisura an33al crónica. DISEO: El estudio es un ensayo clínico controlado, aleatorizado y de dos grupos paralelos. ESCENARIO: El estudio se llevó a cabo en dos hospitales universitarios terciarios. PACIENTES: Cuarenta y cuatro pacientes con fisura anal crónica fueron asignados aleatoriamente al grupo de tratamiento con plasma rico en plaquetas o al grupo control. Los síntomas de presentación y las puntuaciones de dolor se registraron en la inscripción. Los pacientes de control se autoadministraron trinitrato de glicerilo tópico. El plasma rico en plaquetas se inyectó localmente en el grupo de intervención seguido de trinitrato de glicerilo autoadministrado. PRINCIPALES MEDIDAS DE RESULTADO: La principal medida de resultado es una reducción en las puntuaciones de dolor. RESULTADOS: El día 10 y un mes después del tratamiento, la puntuación media de dolor fue significativamente menor en los pacientes con plasma rico en plaquetas que en los controles (p = 0.005 y p <0.005, respectivamente). Un mes después del tratamiento, la puntuación media de dolor disminuyó 5.7 puntos en el grupo tratado con plasma rico en plaquetas en comparación con una disminución de la puntuación media de dolor de 4.1 en el grupo de control (diferencia media: 1.6 puntos [intervalo de confianza del 95%; 0.3-2.9] Según los análisis de medidas repetidas, las puntuaciones de dolor disminuyeron en ambos grupos, pero la disminución en el grupo de tratamiento fue estadísticamente mayor que en el grupo de control (p <0.001). Las tasas de epitelización completa y recuperación fueron significativamente más altas en los pacientes con plasma rico en plaquetas que en los controles en todos los tiempos de seguimiento, con valores de p que van desde 0.034 a <0.001. La diferencia observada en la epitelización completa después de dos meses de tratamiento entre el grupo de plasma rico en plaquetas y el grupo de control fue del 56.2% con un intervalo de confianza del 95% del 14.03% al 98.4%. LIMITACIONES: Este estudio estuvo limitado por el pequeño tamaño de la muestra y porque no se proporcionó un seguimiento a largo plazo de los pacientes. CONCLUSIONES: El plasma rico en plaquetas redujo las molestias y aceleró la epitelización y la curación en pacientes con fisuras anales crónicas. Consulte Video Resumen en http://links.lww.com/DCR/B461. (Traducción-Dr. Jorge Silva Velazco).

Cosmetic Practitioners Take Huge Risks Purchasing and Administering Illegal Botulinum Toxin Drug Products.

In their article "Importing Injectables" in the September 2014 issue of the Journal of Drugs in Dermatology, Dr. Kenneth Beer and Karen Rothschild highlighted the possible harm to patients and practitioners from the use of unapproved botulinum toxin products - eg, Botox, Dysport, Xeomin, and Myobloc - and other cosmetic prescription drug products purchased from foreign or unlicensed suppliers.1 In the intervening years, the accuracy of their critique has been repeatedly demonstrated, as the dangers to patients' health, as well as to cosmetic practitioners' liberty, has only increased.

Reconstituting botulinum toxin drugs: shaking, stirring or what?

Most botulinum toxin (BT) drugs are stored as powders which need to be reconstituted with normal saline before clinical use. As botulinum neurotoxin (BNT), the therapeutically active ingredient, is a large double-stranded protein the process of reconstitution should be performed with special attention to mechanical stress applied. We wanted to test the mechanical stability of BNT during the reconstitution process. For this, 100 MU onabotulinumtoxinA (Botox(®), Irvine, CA, USA) was reconstituted with 2.0 ml of NaCl/H2O. Gentle reconstitution (GR) was performed with a 5 ml syringe, a 0.90 × 70 mm injection needle, one cycle of injection-aspiration-injection and two gentle shakes of the vial. Aggressive reconstitution (AR) was performed with a 5 ml syringe, a 0.40 × 40 mm injection needle, ten injection-aspiration-injection cycles and 30 s of continuous shaking of the vial. AR increased the time to paralysis in the mouse hemidiaphragm assay (HDA) from 72.0 ± 4.6 to 106.0 ± 16.0 min (*p = 0.002, two-tailed t test after Kolmogorov-Smirnova test with Lilliefors correction for normal distribution). Construction of a calibration curve revealed that the increase in the time to paralysis was correlated with a loss of potency of from 100 to 58 MU (-42 %). BT users should use large diameter injection needles for reconstitution, apply two or three injection-aspiration-injection cycles and, maybe, shake the vials a few times to rinse the entire glass wall. Aggressive reconstitution with small diameter needles, prolonged injection-aspiration-injection and violent shaking should be avoided.

Cómo convencer al jefe de servicio y al gerente de la importancia de las unidades/consultas especializadas de cefaleas / How to convince the head of department and managing director of the importance of specialised headache clinics

A pesar de que la cefalea es, con diferencia, el principal motivo neurológico de consulta, y de la complejidad diagnóstica y terapéutica de algunos pacientes, el número de consultas monográficas de cefalea (CC) y de unidades de cefalea (UC) es muy reducido en nuestro país. En este artículo pasaremos revista a los principales argumentos que nos permitan, como neurólogos, defender la necesidad de la implementación de una CC/UC, dependiendo de la población que se debe atender, en todos nuestros servicios de neurología. Para ello deberemos, en primer lugar, vencer las reticencias internas, que hacen que la cefalea sea aún poco apreciada y atractiva dentro de nuestra especialidad. El hecho de que la cefalea justifique más de un cuarto de las consultas a un servicio de neurología estándar de nuestro país y de que existan más de 200 cefaleas diferentes, algunas de ellas realmente invalidantes, y las nuevas opciones de tratamiento para pacientes crónicos, como la OnabotulinumtoxinA para la migraña crónica o las técnicas de neuromodulación, obligan a introducir dentro de nuestras carteras de servicios la asistencia especializada en cefaleas. Aunque no disponemos de datos incontrovertibles, existen ya datos suficientes en la literatura que indican que esta atención es eficiente en pacientes con cefaleas crónicas no sólo en términos de salud, sino también desde el punto de vista económico (AU)

In spite that headache is, by far, the most frequent reason for neurological consultation and that the diagnosis and treatment of some patients with headache is difficult, the number of headache clinics is scarce in our country. In this paper the main arguments which should allow us, as neurologists, to defend the necessity of implementing headache clinics are reviewed. To get this aim we should first overcome our internal reluctances, which still make headache as scarcely appreciated within our specialty. The facts that more than a quarter of consultations to our Neurology Services are due to headache, that there are more than 200 different headaches, some of them actually invalidating, and the new therapeutic options for chronic patients, such as OnabotulinumtoxinA or neuromodulation techniques, oblige us to introduce specialised headache attendance in our current neurological offer. Even though there are no definite data, available results indicate that headache clinics are efficient in patients with chronic headaches, not only in terms of health benefit but also from an economical point of view (AU)

Botulinum toxin assessment, intervention and after-care for lower limb spasticity in children with cerebral palsy: international consensus statement.

Botulinum neurotoxin type-A (BoNT-A) has been used in association with other interventions in the management of spasticity in children with cerebral palsy (CP) for almost two decades. This consensus statement is based on an extensive review of the literature by an invited international committee. The use of BoNT-A in the lower limbs of children with spasticity caused by CP is reported using the American Academy of Neurology Classification of Evidence for therapeutic intervention. Randomized clinical trials have been grouped into five areas of management, and the outcomes are presented as treatment recommendations. The assessment of children with CP and evaluation of outcomes following injection of BoNT-A are complex, and therefore, a range of measures and the involvement of a multidisciplinary team is recommended. The committee concludes that injection of BoNT-A in children with CP is generally safe although systemic adverse events may occur, especially in children with more physical limitations (GMFCS V). The recommended dose levels are intermediate between previous consensus statements. The committee further concludes that injection of BoNT-A is effective in the management of lower limb spasticity in children with CP, and when combined with physiotherapy and the use of orthoses, these interventions may improve gait and goal attainment.

The updated European Consensus 2009 on the use of Botulinum toxin for children with cerebral palsy.

An interdisciplinary European group of clinical experts in the field of movement disorders and experienced Botulinum toxin users has updated the consensus for the use of Botulinum toxin in the treatment of children with cerebral palsy (CP). A problem-orientated approach was used focussing on both published and practice-based evidence. In part I of the consensus the authors have tabulated the supporting evidence to produce a concise but comprehensive information base, pooling data and experience from 36 institutions in 9 European countries which involves more than 10,000 patients and over 45,000 treatment sessions during a period of more than 280 treatment years. In part II of the consensus the Gross Motor Function Measure (GMFM) and Gross Motor Function Classification System (GMFCS) based Motor Development Curves have been expanded to provide a graphical framework on how to treat the motor disorders in children with CP. This graph is named "CP(Graph) Treatment Modalities - Gross Motor Function" and is intended to facilitate communication between parents, therapists and medical doctors concerning (1) achievable motor function, (2) realistic goal-setting and (3) treatment perspectives for children with CP. The updated European consensus 2009 summarises the current understanding regarding an integrated, multidisciplinary treatment approach using Botulinum toxin for the treatment of children with CP.

European consensus table 2006 on botulinum toxin for children with cerebral palsy.

An interdisciplinary group of experienced botulinum toxin users and experts in the field of movement disorders was assembled, to develop a consensus on best practice for the treatment of cerebral palsy using a problem-orientated approach to integrate theories and methods. The authors tabulated the supporting evidence to produce a condensed but comprehensive information base, pooling data and experience from nine European countries, 13 institutions and more than 5500 patients. The consensus table summarises the current understanding regarding botulinum toxin treatment options in children with CP.

Botulinum toxin therapy of eye muscle disorders. Safety and effectiveness. American Academy of Ophthalmology.

BTX injection has been used for 11 years by 292 ophthalmologists in 8,854 patients aged three months to 90 years in a variety of eye muscle and eyelid disorders. No systemic toxic reaction has occurred, local complications are few, and visual loss has not occurred in any case. In blepharospasm and hemifacial spasm BTX appears to fill an important need, since no other drug is reliably effective and since surgical interventions have substantial side effects. Strabismus cases with active uveitis, hypotony, previous detachment surgery, active thyroid eye disease, and recent paralytic strabismus are often poor candidates for surgical intervention. Some patients in each of these categories were treated effectively and safely by BTX injection. Surgery is clearly the preferred treatment modality in large angle deviations, in chronic paralytic strabismus, in cases where diplopia for a month or two from injection would incapacitate the patient, in nystagmus, in oblique muscle disorders and A-V patterns, where muscles have been misplaced and where restrictions to alignment have been created by disease or prior surgery. Side by side comparisons of surgery and injection in congenital esotropia and in concomitant strabismus of 50 PD or less should result in further clarification of treatment choices as to effectiveness, side effects and cost. BTX is presently available only to clinical investigators using the drug under research protocols.