{
  "abstract": "The psychosocial impact of taking part in clinical trials of gene therapy for rare conditions on participants and their families is not well understood. Systematic reviews and thematic syntheses were conducted to better understand the experiences of a) adults who have taken part in clinical trials and b) the parents of children who have taken part in clinical trials. The SPIDER framework was used to identify primary qualitative research articles. The quality of the articles included was appraised using the CASP tool for qualitative research. Five papers were identified for the review focusing on adults, and three for the review focusing on parents. A thematic synthesis methodology was used to organise, analyse and interpret the findings from the primary articles. Three main analytical themes were identified for adults: a gap in psychological support for participants; the transformative impact on quality of life; and, navigating uncertainty in gene therapy. Three key analytical themes were identified for parents: parental roles; expectations and emotional impact; and, the importance of relationships and communication. It is important to develop more patient-centred and robust patient-reported outcomes and measures so that these issues are addressed in a clinical trial experience which is meaningful for patients and families.",
  "authors": [
    {
      "affiliations": [
        "The University of Manchester, Manchester"
      ],
      "name": "Faye Johnson"
    },
    {
      "affiliations": [
        "The University of Manchester, Manchester",
        "Manchester University NHS Foundation Trust, Manchester"
      ],
      "name": "A Clements"
    },
    {
      "affiliations": [
        "The University of Manchester, Manchester",
        "Manchester University NHS Foundation Trust, Manchester"
      ],
      "name": "M Diemer"
    },
    {
      "affiliations": [
        "The University of Manchester, Manchester",
        "Manchester University NHS Foundation Trust, Manchester"
      ],
      "name": "T Clancy"
    }
  ],
  "title": "P17 Systematic reviews of the psychosocial impact of taking part in clinical trials of gene therapy for rare conditions",
  "uid": "52dec5c1-38a1-58d3-a001-f09301549246"
}