Lopez-Alcalde Jesus, Tietjen Anna K, Yan Yuqian, Canella Claudia, Barth Jürgen, Steinemann Nina, Hägele-Link Stefan, Bolt Sarah, Baum Claudia, Rettenmund Gabriela, von Wyl Viktor, Nonino Francesco, Wieland L Susan, Wang Xiaying, Schmick Anton, Pagnini Francesco, Kesselring Jürg, Khazaei Hosna, Pérez-Neri Iván, Studer-Merkle Ute, Witt Claudia M
Institute for Complementary and Integrative Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland
Facultad de Medicina, Universidad Francisco de Vitoria, Pozuelo de Alarcón, Spain.
BMJ Open. 2025 Jul 25;15(7):e095764. doi: 10.1136/bmjopen-2024-095764.
This study aimed to develop a core outcome set (COS) for trials evaluating the effects of complementary therapies in people with multiple sclerosis (pwMS). We sought to identify the outcomes most relevant to pwMS, their relatives and friends, healthcare professionals and researchers and to propose these for inclusion in future trials.
A participatory international research project using a mixed-method approach with qualitative and quantitative methods. The study included a scoping review and a national survey in Switzerland to identify candidate outcomes, followed by an international COS survey to rate the importance of these outcomes. The final phases involved two consensus meetings to refine and finalise the COS.
Data were sourced from the published literature and input from international stakeholders.
pwMS and other relevant stakeholders, including their relatives and friends, healthcare professionals and researchers.
A total of 770 individuals participated in the international COS survey of 39 candidate outcomes (662 pwMS, 27 relatives/friends, 58 healthcare professionals and 23 researchers). According to the survey results, 13 outcomes were added to the COS, 5 were excluded and 21 were classified as 'no consensus'. 13 individuals (six pwMS, one pwMS's friend, three healthcare professionals and three researchers) attended the first consensus meeting. Following the voting on the outcomes without consensus, seven outcomes were added to the COS, four were excluded and 10 outcomes were still classified as 'no consensus'. The six members of the stakeholders advisory board (one pwMS, four healthcare professionals and two researchers) attended the second consensus meeting to define the final COS. Nine additional outcomes were included in the COS. Sexual problems, an outcome previously excluded, were also added. In total, 30 outcomes were included in the final COS.
We have developed the first COS for future trials of complementary therapies for pwMS. The use of this COS will promote that future research in complementary therapies is relevant for pwMS and other stakeholders involved in MS care. Future COS research should integrate diverse geographical regions, where perspectives and access to complementary therapies may vary.
本研究旨在为评估补充疗法对多发性硬化症患者（pwMS）疗效的试验制定核心结局集（COS）。我们试图确定对pwMS患者、其亲属和朋友、医疗保健专业人员及研究人员最为相关的结局，并提议将这些结局纳入未来的试验。
一项参与性国际研究项目，采用定性和定量相结合的混合方法。该研究包括一项范围综述和在瑞士进行的一项全国性调查，以确定候选结局，随后进行一项国际COS调查，以评估这些结局的重要性。最后阶段包括两次共识会议，以完善并最终确定COS。
数据来源于已发表的文献以及国际利益相关者的意见。
pwMS患者及其他相关利益者，包括其亲属和朋友、医疗保健专业人员及研究人员。
共有770人参与了对39个候选结局的国际COS调查（662名pwMS患者、27名亲属/朋友、58名医疗保健专业人员和23名研究人员）。根据调查结果，13个结局被纳入COS，5个被排除，21个被归类为“未达成共识”。13人（6名pwMS患者、1名pwMS患者的朋友、3名医疗保健专业人员和3名研究人员）参加了第一次共识会议。在对未达成共识的结局进行投票后，7个结局被纳入COS，4个被排除，10个结局仍被归类为“未达成共识”。利益相关者咨询委员会的6名成员（1名pwMS患者、4名医疗保健专业人员和2名研究人员）参加了第二次共识会议，以确定最终的COS。另外9个结局被纳入COS。之前被排除的“性问题”结局也被添加进来。最终的COS共纳入30个结局。
我们已为未来针对pwMS患者的补充疗法试验制定了首个COS。使用该COS将促进未来补充疗法的研究与pwMS患者及其他参与MS护理的利益相关者相关。未来的COS研究应整合不同地理区域，因为不同地区对补充疗法的看法和使用情况可能存在差异。
