{
  "abstract": "Introduction This study aimed to either identify or develop and validate a patient-reported outcome measure (PROM) to assess treatment burden related to general practice for patients with multimorbidity, which can be used alongside the MultiMorbidity Questionnaire part 1 (MMQ1) without overwhelming the target population with redundant items.Methods We conducted a systematic literature review to identify all existing PROMs measuring treatment burden. If no suitable PROM was found, our plan was to: (1) develop a draft PROM using items from existing instruments, (2) carry out group and individual interviews with patients with multimorbidity to ensure the PROM’s understandability, clarity, completeness and relevance and (3) undertake psychometric validation with a diverse sample of primary care patients with chronic conditions.Results We did not identify an eligible PROM in the literature review. The draft PROM consisted of 30 items divided into six domains; Information about treatment, Challenges with medication, Medical appointments, Self-monitoring, Health behaviour and Challenges in the contact to the health system. In the psychometric validation, neither these domains nor any other theoretical constellation of items had adequate psychometric properties. Individual items had good criterion validity and sensitivity to change.Conclusions In this study, we developed a 30-item PROM with high content validity where various individual items showed adequate criterion validity and sensitivity to change, making these items useful as a supplemental measure to the MMQ1.Trial registration number NCT05676541 Registration Date: 16 December 2022.",
  "authors": [
    {
      "affiliations": [
        "Department of Public Health, University of Copenhagen Centre of General Practice, Copenhagen, Denmark"
      ],
      "name": "Anna Bernhardt Lyhnebeck"
    },
    {
      "affiliations": [
        "Department of Public Health, University of Copenhagen Centre of General Practice, Copenhagen, Denmark"
      ],
      "name": "Anne Holm"
    },
    {
      "affiliations": [
        "Department of Public Health, University of Southern Denmark Research Unit of General Practice, Odense, Denmark"
      ],
      "name": "Sussi Friis Buhl"
    },
    {
      "affiliations": [
        "Department of Public Health, University of Copenhagen Centre of General Practice, Copenhagen, Denmark"
      ],
      "name": "Kristine Henderson Bissenbakker"
    },
    {
      "affiliations": [
        "Department of Clinical, Aalborg Universitet, Aalborg, Denmark"
      ],
      "name": "Jette Kolding Kristensen"
    },
    {
      "affiliations": [
        "Department of Public Health, University of Copenhagen Centre of General Practice, Copenhagen, Denmark"
      ],
      "name": "Anne Møller"
    },
    {
      "affiliations": [
        "Aarhus University Research Unit for General Practice, Aarhus, Denmark"
      ],
      "name": "Anders Prior"
    },
    {
      "affiliations": [
        "Department of Public Health, University of Copenhagen Centre of General Practice, Copenhagen, Denmark"
      ],
      "name": "Zaza Kamper-Jørgensen"
    },
    {
      "affiliations": [
        "Department of Public Health, University of Copenhagen Centre of General Practice, Copenhagen, Denmark"
      ],
      "name": "Sidsel Böcher"
    },
    {
      "affiliations": [
        "Department of Public Health, University of Copenhagen Centre of General Practice, Copenhagen, Denmark"
      ],
      "name": "Mads Kristensen"
    },
    {
      "affiliations": [
        "Department of Public Health, University of Copenhagen Centre of General Practice, Copenhagen, Denmark"
      ],
      "name": "Asger Waagepetersen"
    },
    {
      "affiliations": [
        "Department of Public Health, University of Copenhagen Centre of General Practice, Copenhagen, Denmark"
      ],
      "name": "Anders Hye Dalsgaard"
    },
    {
      "affiliations": [
        "University of Copenhagen, Research Unit for General Practice, Copenhagen, Denmark"
      ],
      "name": "Volkert Siersma"
    },
    {
      "affiliations": [
        "Department of Public Health, University of Copenhagen Centre of General Practice, Copenhagen, Denmark",
        "UiT The Arctic University of Norway, General Practice Research Unit, Tromsø, Norway"
      ],
      "name": "John Brandt Brodersen"
    },
    {
      "affiliations": [],
      "name": "on behalf of the MM600 trial group"
    }
  ],
  "title": "Measuring treatment burden related to general practice in patients with multimorbidity: development and validation of a PROM",
  "uid": "bcd42e6d-ca4a-573a-b820-670a71e3ff4f"
}