BoNT-A for post-stroke spasticity: guidance on unmet clinical needs from a Delphi panel approach

There is extensive literature supporting the efficacy of botulinum toxin (BoNT-A) for the treatment of post-stroke spasticity, however, there remain gaps in the routine management of patients with post-stroke spasticity. A panel of 21 Italian experts was selected to participate in this web-based survey Delphi process to provide guidance that can support clinicians in the decision-making process. There was a broad consensus among physicians that BoNT-A intervention should be administered as soon as the spasticity interferes with the patients' clinical condition. Patients monitoring is needed over time, a follow-up of 4-6 weeks is considered necessary. Furthermore, physicians agreed that treatment should be offered irrespective of the duration of the spasticity. The Delphi consensus also stressed the importance of patient-centered goals in order to satisfy the clinical needs of the patient regardless of time of onset or duration of spasticity. The findings arising from this Delphi process provide insights into the unmet needs in managing post-stroke spasticity from the clinician's perspective and provides guidance for physicians for the utilization of BoNT-A for the treatment of post-stroke spasticity in daily practice

Treatment of Adult Spasticity With Botox (onabotulinumtoxinA): Development, Insights, and Impact

Upper and lower limb spasticity (ULS, LLS) often occur following a stroke or in patients with other neurological disorders, leading to difficulties in mobility and daily living and decreased quality of life. Prior to the use of onabotulinumtoxinA, antispastic medications had limited efficacy and often caused sedation. Phenol injections were difficult for physicians to perform, painful, and led to tissue destruction. The success of onabotulinumtoxinA in treating cervical dystonia led to its use in spasticity. However, many challenges characterized the development of onabotulinumtoxinA for adult spasticity. The wide variability in the presentation of spasticity among patients rendered it difficult to determine which muscles to inject and how to measure improvement. Another challenge was the initial refusal of the Food and Drug Administration to accept the Ashworth Scale as a primary endpoint. Additional scales were designed to incorporate a goal-oriented, patient-centered approach that also accounted for the variability of spasticity presentations. Several randomized, double-blind, placebo-controlled trials of post-stroke spasticity of the elbow, wrist, and/or fingers showed significantly greater improvements in the modified Ashworth Scale and patient treatment goals and led to the approval of onabotulinumtoxinA for the treatment of ULS in adult patients. Lessons learned from the successful ULS trials were applied to design an LLS trial that led to approval for the latter indication. Additional observational trials mimicking real-world treatment have shown continued effectiveness and patient satisfaction. The use of onabotulinumtoxinA for spasticity has ushered in a more patient-centered treatment approach that has vastly improved patients\u27 quality of life

A Screening Tool to Identify Spasticity in Need of Treatment

OBJECTIVE: To develop a clinically useful patient-reported screening tool for health care providers to identify patients with spasticity in need of treatment regardless of etiology. DESIGN: Eleven spasticity experts participated in a modified Delphi panel and reviewed and revised 2 iterations of a screening tool designed to identify spasticity symptoms and impact on daily function and sleep. Spasticity expert panelists evaluated items pooled from existing questionnaires to gain consensus on the screening tool content. The study also included cognitive interviews of 20 patients with varying spasticity etiologies to determine if the draft screening tool was understandable and relevant to patients with spasticity. RESULTS: The Delphi panel reached an initial consensus on 21 of 47 items for the screening tool and determined that the tool should have no more than 11 to 15 items and a 1-month recall period for symptom and impact items. After 2 rounds of review, 13 items were selected and modified by the expert panelists. Most patients (n = 16 [80%]) completed the cognitive interview and interpreted the items as intended. CONCLUSIONS: Through the use of a Delphi panel and patient interviews, a 13-item spasticity screening tool was developed that will be practical and easy to use in routine clinical practice

Improving Delivery of Acute Stroke Therapy

Background and Purpose— Only a small minority of acute stroke patients receive approved acute stroke therapy. We performed a community and professional behavioral intervention project to increase the proportion of stroke patients treated with approved acute stroke therapy. Methods— This study used a quasi-experimental design. Intervention and comparison communities were compared at baseline and during educational intervention. The communities were based in 5 nonurban East Texas counties. The multilevel intervention worked with hospitals and community physicians while changing the stroke identification skills, outcome expectations, and social norms of community residents. The primary goal was to increase the proportion of patients treated with intravenous recombinant tissue plasminogen activator (rTPA) from 1% to 6% of all cerebrovascular events in the intervention community. Results— We prospectively evaluated 1733 patients and validated 1189 cerebrovascular events. Intravenous rTPA treatment increased from 1.38% to 5.75% among all cerebrovascular event patients in the intervention community (P=0.01) compared with a change from 0.49% to 0.55% in the comparison community (P=1.00). Among the ischemic stroke patients, an increase from 2.21% to 8.65% was noted in the intervention community (P=0.02). The comparison group did not appreciably change (0.71% to 0.86%, P=1.00). Of eligible intravenous rTPA candidates, treatment increased in the intervention community from 14% to 52% (P=0.003) and was unchanged in the comparison community (7% to 6%, P=1.00). Conclusions— An aggressive, multilevel stroke educational intervention program can increase delivery of acute stroke therapy. This may have important public health implications for reducing disability on a national level

Nocturia think tank: Focus on nocturnal polyuria: ICI-RS 2011

The following is a report of the proceedings of the Nocturia Think Tank sessions of the annual International Consultation on Incontinence-Research Society, which took place June 1315, 2011 in Bristol, UK. The report is organized into sections pertaining to the main topics of discussions having occurred at that meeting, centering on the relationship of nocturnal polyuria (NP) and nocturia but also synthesizing more current evidence advancing our knowledge of the diagnosis and management of nocturia. This article is not meant to be a comprehensive review on the subject of nocturia, a number of which are available in the recent literature. All authors were physically present during, or in a preliminary session just prior to, the meeting in Bristol. Neurourol. Urodynam. 31:330339, 2012

International recommendations to manage post-stroke Equinovarus Foot deformity validated by a panel of experts using DELPHI.

This study intended to establish international recommendations for the management of spastic equinovarus foot deformity. Delphi method SETTING: International study PARTICIPANTS: 24 international experts in neuro-orthopedic deformities, from different specialties (Physical and Rehabilitation Medicine physicians, neurologists, geriatricians, orthopaedic surgeons, neurosurgeons, and plastic surgeons) INTERVENTIONS: Experts answered three rounds of questions related to important aspects of diagnosis, assessment and treatment of spastic equinovarus foot deformity. A consensus was established when at least 80% of experts agreed on a statement RESULTS: : A total of 52 items reached consensus. Experts recommend assessing impact of the deformity on functional activities before treatment. Before treatment, it is crucial to differentiate spastic muscle overactivity from soft tissue contractures, identify which muscles are involved in the deformity and evaluate the activity of antagonist muscles. Motor nerve blocks, two-dimensional video analysis and radiological exams are often required to complement a clinical exam. The treatment of equinovarus foot depends on the correctability of the deformity, but also the patient's ability to stand or walk. The preoperative assessment should include an interdisciplinary consultation that must finalize a formal agreement between doctors and the patient, which will define personalized attainable goals before surgery. The establishment of guidelines on managing equinovarus foot will help physicians and surgeons, specialists, and non-specialists to diagnoses and assess the deformity and direct patients to a network of experts, in order to optimize patient functional recovery and improve their autonomy

A Delphi-Based Consensus Statement on the Management of Anticoagulated Patients With Botulinum Toxin for Limb Spasticity.

Objective To create a consensus statement on the considerations for treatment of anticoagulated patients with botulinum toxin A (BoNTA) intramuscular injections for limb spasticity. Design We used the Delphi method. Setting A multiquestion electronic survey. Participants Canadian physicians (N=39) who use BoNTA injections for spasticity management in their practice. Interventions After the survey was sent, there were e-mail discussions to facilitate an understanding of the issues underlying the responses. Consensus for each question was reached when agreement level was ≥75%. Main Outcome Measures Not applicable. Results When injecting BoNTA in anticoagulated patients: (1) BoNTA injections should not be withheld regardless of muscles injected; (2) a 25G or smaller size needle should be used when injecting into the deep leg compartment muscles; (3) international normalized ratio (INR) level should be ≤3.5 when injecting the deep leg compartment muscles; (4) if there are clinical concerns such as history of a fluctuating INR, recent bleeding, excessive or new bruising, then an INR value on the day of injection with point-of-care testing or within the preceding 2-3 days should be taken into consideration when injecting deep compartment muscles; (5) the concern regarding bleeding when using direct oral anticoagulants (DOACs) should be the same as with warfarin (when INR is in the therapeutic range); (6) the dose and scheduling of DOACs should not be altered for the purpose of minimizing the risk of bleeding prior to BoNTA injections. Conclusions These consensus statements provide a framework for physicians to consider when injecting BoNTA for spasticity in anticoagulated patients. These consensus statements are not strict guidelines or decision-making steps, but rather an effort to generate common understanding in the absence of evidence in the literature