疼痛管理临床试验中导致招募缓慢的障碍的思考:来自比利时PELICAN(普瑞巴林利多卡因辣椒素神经性疼痛)实用研究的经验

IF 2.5 3区 医学 Q2 CLINICAL NEUROLOGY
Guy H Hans, Dima Almeshal, Lotte Vanlommel, Ella Roelant, Iris Verhaegen, Elke Smits, Koen Van Boxem, Robert Fontaine, The Pelican Investigators Team
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引用次数: 0

摘要

背景:对过早终止的普瑞巴林利多卡因辣椒素神经性疼痛(PELICAN)研究进行了定性评价。PELICAN研究旨在检查局部神经性疼痛(LNP)的疼痛管理,因为流行病学数据显示比利时LNP患者的比例很高。该研究根据疼痛缓解、不良反应和一些生活质量指标比较了全身和局部药物治疗。目的:通过质性研究更好地招募研究患者。为了调查和确定在PELICAN研究中观察到的招募问题的原因,研究人员包括了参与研究的疼痛中心和未招募的疼痛中心。此外,它旨在强调从所进行的研究中吸取的积极和消极的教训,以及该小组必须克服的障碍的数量。方法:采用混合方法进行定性研究。比利时的多个疼痛中心完成了一项在线调查,之后进行了一次结构化的访谈,以更详细地阐述反应。这些会议的广泛主题是对研究的反馈,审查调查答案,以及为加强招聘而采取的行动。结果:不同的因素导致了PELICAN研究的低招募率,如全科医生向比利时疼痛中心的转诊有限和较晚,非疼痛专家的内部转诊不足,一些中心缺乏LNP的专业知识,人员短缺,实施复杂镇痛方案的报销有限,对患者群体的高估,以及患者不愿参与疼痛研究。此外,还确定了实施研究设计的缺点和需要更多的后勤投资。结论:定性研究的结果表明,比利时需要进一步,更多样化的LNP研究,而不仅仅局限于药理学研究。它还揭示了在这些研究过程中可能面临的招聘障碍。未来的研究可以通过为可行性和招聘提供更好的建议来支持这一研究,例如,通过设计和实施一项引人注目的试点研究或在招聘阶段应用社交媒体。临床试验本试验注册号为NCT03348735。EUDRACT编号2018-003617-17。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Considerations on the Obstacles That Lead to Slow Recruitment in a Pain Management Clinical Trial: Experiences from the Belgian PELICAN (PrEgabalin Lidocaine Capsaicin Neuropathic Pain) Pragmatic Study.

Considerations on the Obstacles That Lead to Slow Recruitment in a Pain Management Clinical Trial: Experiences from the Belgian PELICAN (PrEgabalin Lidocaine Capsaicin Neuropathic Pain) Pragmatic Study.

Considerations on the Obstacles That Lead to Slow Recruitment in a Pain Management Clinical Trial: Experiences from the Belgian PELICAN (PrEgabalin Lidocaine Capsaicin Neuropathic Pain) Pragmatic Study.

Background: A qualitative evaluation study of the prematurely terminated PrEgabalin Lidocaine Capsaicin Neuropathic Pain (PELICAN) study was performed. The PELICAN study aimed to examine pain management for localized neuropathic pain (LNP), as epidemiological figures have shown a high percentage of LNP patients in Belgium. The study compared systemic and topical medications according to pain relief, adverse effects, and several measures of quality of life.

Objective: Achieving better study patient recruitment through qualitative research. To investigate and determine the causes of the observed recruitment problems in the PELICAN study, pain centers involved in the study as well as nonrecruiting pain centers were included. Furthermore, it aimed to highlight the positive and negative lessons learned from the conducted study and the number of obstacles the team had to overcome.

Methods: A qualitative study, using a mixed methods approach, was performed. Multiple pain centers in Belgium completed an online survey, after which a structured interview was conducted to elaborate the responses in more detail. The broad topics of these meetings were feedback about the study, reviewing survey answers, and actions undertaken to enhance recruitment.

Results: Different factors contributed to the low recruitment rate in the PELICAN study, such as limited and late referral from the general practitioners to the Belgian pain centers, insufficient internal referrals from nonpain specialists, lack of specific expertise on LNP in some centers, scarcity of staff, limited reimbursement to administer complex analgesic schemes, overestimation of the patient population, and the reluctance of patients to participate in pain research. Additionally, shortcomings in the implemented study design and the need for more logistical investments were identified.

Conclusion: The findings of the qualitative study demonstrate the need for further, more varied LNP research in Belgium, not limited to pharmacological studies. It also sheds important light on the recruitment obstacles that may be faced during these studies. Future studies could support this research by offering better proposals for feasibility and recruitment, for instance, by designing and conducting a compelling pilot study or applying social media during the recruitment phase. Clinical Trials. This trial is registered with NCT03348735. EUDRACT number 2018-003617-17.

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来源期刊
Pain Research & Management
Pain Research & Management CLINICAL NEUROLOGY-
CiteScore
5.30
自引率
0.00%
发文量
109
审稿时长
>12 weeks
期刊介绍: Pain Research and Management is a peer-reviewed, Open Access journal that publishes original research articles, review articles, and clinical studies in all areas of pain management. The most recent Impact Factor for Pain Research and Management is 1.685 according to the 2015 Journal Citation Reports released by Thomson Reuters in 2016.
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