Evidence map›Paper›PMID 34006020›Full record

Trial reportBMJ open2021

Experiences and perceptions of patients with psoriatic arthritis participating in a trial of faecal microbiota transplantation: a nested qualitative study.

Maja Skov Kragsnaes, Shaun Theodor Sødergren, Jens Kjeldsen, Hans Christian Horn, Heidi Lausten Munk, Jens Kristian Pedersen, Camilla Schufri Klinkby, Maarten de Wit, Nanna Gram Ahlmark, Tine Tjørnhøj-Thomsen and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03058900 (Efficacy and Safety of Fecal Microbiota Transplantation), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.2field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03058900 nacompletednot on this map

Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Peripheral Psoriatic Arthritis: a 6-month, Double-Blind, Randomized, Placebo-Controlled Trial

TypeinterventionalSponsorOdense University HospitalRan2017 to 2020Enrolled31ConditionsPsoriatic ArthritisArmsFecal microbiota transplantation (FMT), Drug: Placebo (saline), Methotrexate (MTX)
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 20 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Review
  6. Review
  7. The Evolving Landscape of Fecal Microbial Transplantation.Clinical reviews in allergy & immunology · 2023
    Review
  8. Review
  9. Gut Dysbiosis and Fecal Microbiota Transplantation in Autoimmune Diseases.International journal of molecular sciences · 2022
    Review
  10. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Maja Skov KragsnaesDepartment of Rheumatology, Odense University Hospital, Odense, Denmark d063631@dadlnet.dk.ORCID 0000-0001-9641-9065
Shaun Theodor SødergrenDepartment of Rheumatology, Odense University Hospital, Odense, Denmark.ORCID 0000-0001-5854-2142
Jens KjeldsenDepartment of Gastroenterology, Odense University Hospital, Odense, Denmark.ORCID 0000-0001-8148-6572
Hans Christian HornDepartment of Rheumatology, Odense University Hospital, Odense, Denmark.
Heidi Lausten MunkDepartment of Rheumatology, Odense University Hospital, Odense, Denmark.
Jens Kristian PedersenDepartment of Medicine, Svendborg Hospital, Odense University Hospital, Svendborg, Denmark.
Camilla Schufri KlinkbyDepartment of Rheumatology, Odense University Hospital, Odense, Denmark.
Maarten de WitPatient Research Partner, Amsterdam, Netherlands.ORCID 0000-0002-8428-6354
Nanna Gram AhlmarkNational Institute of Public Health, University of Southern Denmark, Odense, Denmark.ORCID 0000-0002-0539-2061
Tine Tjørnhøj-ThomsenNational Institute of Public Health, University of Southern Denmark, Odense, Denmark.
Torkell EllingsenDepartment of Rheumatology, Odense University Hospital, Odense, Denmark.ORCID 0000-0003-0426-4962
Odense University Hospital · DKUniversity of Southern Denmark · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesPatients' 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.

designIn 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.

settingA Danish rheumatology university outpatient clinic with nationwide inclusion.

participantsThe 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.

resultsParticipation 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.

conclusionsDiscrepancies 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.

Indexed as

Antirheumatic AgentsArthritis, PsoriaticDouble-Blind MethodFecal Microbiota TransplantationHumansPerceptionAntirheumatic Agentsqualitative researchrheumatologytherapeutics

Identifiers

PMID34006020
PMCPMC7942243
OpenAlexW3134423621

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.