{
  "abstract": "Objectives 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.Design 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.Setting Data were sourced from the published literature and input from international stakeholders.Participants pwMS and other relevant stakeholders, including their relatives and friends, healthcare professionals and researchers.Results 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.Conclusion 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.Study registration number https://osf.io/ys7xt/.",
  "authors": [
    {
      "affiliations": [
        "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",
        "Unidad de Bioestadística Clínica, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, CIBERESP, Cochrane Madrid, Madrid, Spain"
      ],
      "name": "Jesus Lopez-Alcalde"
    },
    {
      "affiliations": [
        "Institute for Complementary and Integrative Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland"
      ],
      "name": "Anna K Tietjen"
    },
    {
      "affiliations": [
        "Institute for Complementary and Integrative Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland"
      ],
      "name": "Yuqian Yan"
    },
    {
      "affiliations": [
        "Institute for Complementary and Integrative Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland",
        "Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Berlin, Germany"
      ],
      "name": "Claudia Canella"
    },
    {
      "affiliations": [
        "Institute for Complementary and Integrative Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland"
      ],
      "name": "Jürgen Barth"
    },
    {
      "affiliations": [
        "Epidemiology, Biostatistics and Prevention Institute. Swiss MS Registry, University of Zurich, Zurich, Switzerland"
      ],
      "name": "Nina Steinemann"
    },
    {
      "affiliations": [
        "HOCH, Kantonsspital St.Gallen Zentrum für Integrative Medizin, St Gallen, Switzerland"
      ],
      "name": "Stefan Hägele-Link"
    },
    {
      "affiliations": [
        "University Hospital Zurich, Zurich, Switzerland"
      ],
      "name": "Sarah Bolt"
    },
    {
      "affiliations": [
        "Rehabilitation Hospital Zihlschlacht, Zihlschlacht, Thurgau, Switzerland"
      ],
      "name": "Claudia Baum"
    },
    {
      "affiliations": [
        "Patient Contributor, St. Gallen, Switzerland"
      ],
      "name": "Gabriela Rettenmund"
    },
    {
      "affiliations": [
        "Epidemiology, Biostatistics and Prevention Institute. Swiss MS Registry, University of Zurich, Zurich, Switzerland",
        "Digital and Mobile Health Group, Institute for Implementation Science in Health Care, University of Zurich, Zurich, Switzerland"
      ],
      "name": "Viktor von Wyl"
    },
    {
      "affiliations": [
        "Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Review Group, IRCCS Istituto Delle Scienze Neurologiche di Bologna, Bologna, Italy"
      ],
      "name": "Francesco Nonino"
    },
    {
      "affiliations": [
        "Institute for Complementary and Integrative Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland"
      ],
      "name": "L Susan Wieland"
    },
    {
      "affiliations": [
        "Department of Information Technology and Electrical Engineering, ETH Zurich, Zurich, Switzerland",
        "Research Department, Swiss University Institution for Traditional Chinese Medicine, Bad Zurzach, Switzerland"
      ],
      "name": "Xiaying Wang"
    },
    {
      "affiliations": [
        "Department of Neurology, University Hospital Zurich, Zurich, Switzerland"
      ],
      "name": "Anton Schmick"
    },
    {
      "affiliations": [
        "Department of Psychology, Università Cattolica del Sacro Cuore, Milano, Italy"
      ],
      "name": "Francesco Pagnini"
    },
    {
      "affiliations": [
        "Head of Department Emeritus Neurology and Neurorehabilitation, Kliniken Valens, Valens, Switzerland",
        "Honorary President, Swiss Multiple Sclerosis Society, Zurich, Switzerland"
      ],
      "name": "Jürg Kesselring"
    },
    {
      "affiliations": [
        "Department of Pharmacology and Toxicology, Alborz University of Medical Sciences, Karaj, Iran (the Islamic Republic of)"
      ],
      "name": "Hosna Khazaei"
    },
    {
      "affiliations": [
        "Evidence Synthesis Unit, National Institute of Rehabilitation Luis Guillermo Ibarra Ibarra, Ciudad de Mexico, Mexico"
      ],
      "name": "Iván Pérez-Neri"
    },
    {
      "affiliations": [
        "Patient Contributor, Luzern, Switzerland"
      ],
      "name": "Ute Studer-Merkle"
    },
    {
      "affiliations": [
        "Institute for Complementary and Integrative Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland",
        "Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Berlin, Germany"
      ],
      "name": "Claudia M Witt"
    }
  ],
  "title": "Development of a core outcome set for the trials of complementary therapies in people with multiple sclerosis: international survey and consensus meetings",
  "uid": "edb8a732-1ae6-5a77-aa39-0e9b7a78c5c9"
}