De Tanti Antonio, Scarponi Federico, Bertoni Michele, Gasperini Giulio, Lanzillo Bernardo, Molteni Franco, Posteraro Federico, Vitale Dino Francesco, Zanpolini Mauro
Cardinal Ferrari Rehabilitation Centre, S. Stefano Institute, Via 4 Novembre 21, 43122, Fontanellato, Parma, Italy.
Dipartimento di Neuroriabilitazione, Unità Gravi Cerebrolesioni Acquisite, Ospedale S Giovanni Battista, Foligno, Perugia, Italy.
Neurol Sci. 2017 Aug;38(8):1429-1435. doi: 10.1007/s10072-017-2972-z. Epub 2017 May 6.
Although widespread in the treatment of generalised spasticity due to severe acquired brain injury, clinical use of intrathecal baclofen administered through an implanted catheter is not yet supported by full scientific evidence. The aim of the study is to provide recommendations for good clinical practice regarding intrathecal baclofen therapy. We used a modified RAND Delphi method to develop consensus-based medical guidelines, involving clinicians who use intrathecal baclofen therapy throughout Italy. The clinicians were asked 38 questions grouped in six areas (patient selection, contraindications for implant, tests prior to implant, method of implant and management of therapy, efficacy evaluation and goal setting, and management of complications). To establish consensus, 75% agreement was required in answers to every question. Consensus was reached on the second round of the Delphi process on 27/38 questions (71%), specifically those regarding identification of objectives, efficacy evaluation, and method of implant and management of therapy, whereas management of complications and contraindications for implant remained critical areas. Despite the limits of our method, a set of recommendations was drawn up for clinical practice in this sector. The study also revealed residual critical areas and indicated future lines of research necessary to reach evidence-based consensus.
尽管鞘内注射巴氯芬通过植入导管给药在治疗严重后天性脑损伤所致的全身性痉挛方面应用广泛，但目前尚未有充分的科学证据支持其临床应用。本研究的目的是为鞘内注射巴氯芬治疗提供良好临床实践的建议。我们采用改良的兰德德尔菲法制定基于共识的医学指南，参与的临床医生来自意大利各地，均使用鞘内注射巴氯芬疗法。向临床医生提出了38个问题，分为六个领域（患者选择、植入禁忌证、植入前检查、植入方法及治疗管理、疗效评估与目标设定、并发症管理）。为达成共识，每个问题的回答需有75%的一致率。在德尔菲法的第二轮中，就38个问题中的27个（71%）达成了共识，具体涉及目标识别、疗效评估以及植入方法和治疗管理等方面，而并发症管理和植入禁忌证仍是关键领域。尽管我们的方法存在局限性，但仍为该领域的临床实践制定了一套建议。该研究还揭示了尚存的关键领域，并指出了达成基于证据的共识所需的未来研究方向。
