Article Text

Original research
Experiences and perceptions of patients with psoriatic arthritis participating in a trial of faecal microbiota transplantation: a nested qualitative study
  1. Maja Skov Kragsnaes1,
  2. Shaun Theodor Sødergren1,2,
  3. Jens Kjeldsen3,
  4. Hans Christian Horn1,
  5. Heidi Lausten Munk1,
  6. Jens Kristian Pedersen4,
  7. Camilla Schufri Klinkby1,
  8. Maarten de Wit5,
  9. Nanna Gram Ahlmark2,
  10. Tine Tjørnhøj-Thomsen2,
  11. Torkell Ellingsen1
  1. 1Department of Rheumatology, Odense University Hospital, Odense, Denmark
  2. 2National Institute of Public Health, University of Southern Denmark, Odense, Denmark
  3. 3Department of Gastroenterology, Odense University Hospital, Odense, Denmark
  4. 4Department of Medicine, Svendborg Hospital, Odense University Hospital, Svendborg, Denmark
  5. 5Patient Research Partner, Amsterdam, Netherlands
  1. Correspondence to Dr Maja Skov Kragsnaes; d063631{at}dadlnet.dk

Abstract

Objectives Patients’ first-hand experiences of faecal microbiota transplantation (FMT) performed in a rheumatological care setting have yet to be elucidated. The objectives were to explore participants’ perceptions of being part of an FMT trial thereby identifying potential trial participation effects and enlightening the patient perspective on the outlook for future FMT trials in rheumatic diseases.

Design In a qualitative study nested within a double-blind, randomised, placebo-controlled trial (RCT) testing FMT as a potential new antirheumatic treatment, semistructured telephone interviews were conducted following the trial participants’ final 26-week visit. Qualitative researchers, who did not take part in the main trial, performed the interviews and the primary analysis. The experiences explored related to the conduct of the RCT and changes in the participants’ everyday life. The analysis was carried out using a thematic approach.

Setting A Danish rheumatology university outpatient clinic with nationwide inclusion.

Participants The study included 10 patients with psoriatic arthritis (PsA) who were unaware of their treatment allocation (FMT/sham transplantation) and completed the final 26-week trial visit.

Results Participation in the RCT influenced the patients’ understanding of PsA and induced positive changes in their everyday life. Renewed hopes for the future in addition to a feeling of enhanced care contributed to significant trial participation effects. FMT was deemed a tolerable and safe treatment.

Conclusions Discrepancies between the clinical and the research setting should be considered when discussing the clinical relevance of the results of the RCT. Overall, patients with PsA who have participated in an RCT testing FMT find the treatment acceptable and safe encouraging more research into the field of microbiota-targeted interventions in rheumatic diseases.

Trial registration number NCT03058900; Pre-results.

  • qualitative research
  • therapeutics
  • rheumatology
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Footnotes

  • MSK and STS are joint first authors.

  • Contributors MSK, STS and TE conceived the study. MSK and STS drafted the interview guide. STS conducted and transcribed the interviews. MSK, TE, JK, HCH, HLM, JKP and CSK contributed to the RCT design, the clinical implementation, and the recruitment of participants. STS, NGA and TT-T performed the initial data analysis. MSK assisted the focused coding of the material and drafted the manuscript. The manuscript was critically revised by TE, NGA, TT-T, STS and MdW. All authors reviewed and approved the final manuscript. MSK and STS contributed equally to the paper.

  • Funding This work was supported by Region of Southern Denmark (16/9793), Odense University Hospital (A1456), Danish Regions (Medicinpuljen; 16/2885), University of Southern Denmark (N/A), the Danish Rheumatism Association (R129-A3556), the Danish Psoriasis Research Fund (N/A), and Novartis Healthcare A/S (unrestricted grant; N/A).

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval The RCT was approved by the Regional Committees on Health Research Ethics for Southern Denmark (S-20150080) and the Danish Data Protection Agency (15/41684). The qualitative study did not require any additional approvals on the first approval as confirmed by the Ethics Committee. SS obtained the written and verbal informed consent of each participant before conducting the interview. He also made sure that the participants had read the study information sheet sent to them prior to the interview and that they were informed about their rights as participants, that the conversation would remain confidential, and that the transcript would be anonymised.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement No data are available.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.