Dataset Information

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

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.

SUBMITTER: Kragsnaes MS

PROVIDER: S-EPMC7942243 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:INTRODUCTION:An unbalanced intestinal microbiota may mediate activation of the inflammatory pathways seen in psoriatic arthritis (PsA). A randomised, placebo-controlled trial of faecal microbiota transplantation (FMT) infused into the small intestine of patients with PsA with active peripheral disease who are non-responsive to methotrexate (MTX) treatment will be conducted. The objective is to explore clinical aspects associated with FMT performed in patients with PsA. METHODS AND ANALYSIS:This trial is a randomised, two-centre stratified, double-blind (patient, care provider and outcome assessor), placebo-controlled, parallel-group study. Eighty patients will be included and randomised (1:1) to either placebo (saline) or FMT provided from an anonymous healthy donor. Throughout the study, both groups will continue the weekly self-administered subcutaneous MTX treatment, remaining on the preinclusion dosage (15-25 mg/week). The clinical measures of psoriasis and PsA disease activity used include the Short (2-page) Health Assessment Questionnaire, the Dermatology Quality of Life Index, the Spondyloarthritis Research Consortium of Canada Enthesitis Index, the Psoriasis Area Severity Index, a dactylitis digit count, a swollen/tender joint count (66/68), plasma C reactive protein as well as visual analogue scales for pain, fatigue and patient and physician global assessments. The primary end point is the proportion of patients who experience treatment failure during the 6-month trial period. The number of adverse events will be registered throughout the study. ETHICS AND DISSEMINATION:This is a proof-of-concept clinical trial and will be performed in agreement with Good Clinical Practice standards. Approvals have been obtained from the local Ethics Committee (DK-S-20150080) and the Danish Data Protection Agency (15/41684). The study has commenced in May 2017. Dissemination will be through presentations at national and international conferences and through publications in international peer-reviewed journal(s). TRIAL REGISTRATION NUMBER:NCT03058900; Pre-results.

Project description:ObjectivesThe gut microbiota can mediate both pro and anti-inflammatory responses. In patients with psoriatic arthritis (PsA), we investigated the impact of faecal microbiota transplantation (FMT), relative to sham transplantation, on 92 inflammation-associated plasma proteins.MethodsThis study relates to the FLORA trial cohort, where 31 patients with moderate-to-high peripheral PsA disease activity, despite at least 3 months of methotrexate treatment, were included in a 26-week, double-blind, randomised, sham-controlled trial. Participants were allocated to receive either one gastroscopic-guided healthy donor FMT (n=15) or sham (n=16). Patient plasma samples were collected at baseline, week 4, 12 and 26 while samples from 31 age-matched and sex-matched healthy controls (HC) were collected at baseline. Samples were analysed using proximity extension assay technology (Olink Target-96 Inflammation panel).ResultsLevels of 26 proteins differed significantly between PsA and HC pre-FMT (adjusted p<0.05), of which 10 proteins were elevated in PsA: IL-6, CCL20, CCL19, CDCP1, FGF-21, HGF, interferon-γ (IFN-γ), IL-18R1, monocyte chemotactic protein 3, and IL-2. In the FMT group, levels of 12 proteins changed significantly across all timepoints (tumour necrosis factor (TNF), CDCP1, IFN-γ, TWEAK, signalling lymphocytic activation molecule (SLAMF1), CD8A, CD5, Flt3L, CCL25, FGF-23, CD6, caspase-8). Significant differences in protein levels between FMT and sham-treated patients were observed for TNF (p=0.002), IFN-γ (p=0.011), stem cell factor (p=0.024), matrix metalloproteinase-1 (p=0.038), and SLAMF1 (p=0.042). FMT had the largest positive effect on IFN-γ, Axin-1 and CCL25 and the largest negative effect on CCL19 and IL-6.ConclusionsPatients with active PsA have a distinct immunological plasma protein signature compared with HC pre-FMT. FMT affects several of these disease markers, including sustained elevation of IFN-γ.Trial registration numberNCT03058900.

Project description:BackgroundThe EVERREST Prospective Study is a multicentre observational cohort study of pregnancies affected by severe early-onset fetal growth restriction. The study recruits women with singleton pregnancies where the estimated fetal weight is less than the 3rd centile and below 600 g, between 20 + 0 and 26 + 6 weeks of pregnancy, in the absence of a known chromosomal, structural or infective cause.MethodThe reported study was retrospective descriptive qualitative interview study of women who had participated in the EVERREST Prospective Study. The aim of this study was to explore the experiences and perceptions of pregnant women taking part in research during a pregnancy affected by severe early-onset fetal growth restriction. Audio-recorded semi-structured telephone interviews were conducted with a purposive sample of 12 women, at least 1 year after delivery of their baby. Two of these pregnancies had ended in stillbirth and one in neonatal death, reflecting the outcomes seen in the EVERREST Prospective Study. Participants gave informed consent, were 16 years or older and were interviewed in English. A topic guide was used to ensure a consistent approach. Questions focused on pregnancy experiences, involvement with the EVERREST study and potential involvement in future research. Recordings were transcribed verbatim for thematic analysis using NVivo10.ResultsFour broad themes were identified; 'before joining the EVERREST Prospective Study', 'participating in research', 'information and support' and 'looking back and looking forwards'. Each broad theme incorporated several subthemes. All participants recalled their reaction to being told their baby was smaller than expected. The way this news was given had a lasting impact. A range of benefits of participation in the EVERREST Prospective Study were described and the participants were positive about the way it was conducted. As a consequence, they were receptive to participating in future research. However, the findings suggest that research teams should be sensitive when approaching families at a difficult time or when they are already participating in other research.ConclusionsThis study highlights the willingness of pregnant women to participate in research and identifies strategies for researchers to engage participants.

Project description:BackgroundDespite the benefits of regular physical activity, women in every age group have lower activity levels than men, and few women meet the recommended levels of physical activity. Digital technologies have been useful in increasing physical activity during the course of an interventional study. However, sustaining that activity once the clinical trial was complete was a major challenge.ObjectiveThis study aimed to describe the experiences and perspectives of physically inactive women who completed the mobile phone-based physical activity education (mPED), a randomized controlled trial, at 12 months.MethodsOf 210 women who were enrolled in the mPED trial, 203 completed a 12-month open-ended exit interview and survey through phone. The participants were asked about their physical activity levels; their digital technology use; what they learned from, liked, and would change about the trial; their motivations to keep active post-trial; and their advice for other women. Interviews were transcribed verbatim and thematically analyzed using the brief survey qualitative description. Descriptive statistics were used to describe the survey data with the significance level set at P<.05.ResultsIn the 12-month survey, a greater proportion of the participants in the intervention group, compared with the control group, reported that they regularly wore a pedometer or physical activity tracker (49.3%, 66/143 vs 26.1%, 18/69; P=.002) and engaged in brisk walking (54.5%, 73/134 vs 30.4%, 21/69; P=.001). The experiences and perceptions of physical activity of physically inactive women over time were embedded in a complex interplay of internal and external factors. A total of 6 interactive themes emerged as critical in supporting continued engagement in physical activity postintervention: tracking, technology versus personal touch, accountability, resources and environment, motivation, and habit formation. Technology allowed for self-tracking, which supported internal accountability. However, tracking by another person (personal touch) was needed for external accountability. Resources and environment underpinned the relationship among the themes of tracking, technology versus personal touch, accountability, motivation, and habit formation.ConclusionsFuture research is needed to identify the best ways to harness this dynamic process in promoting and sustaining physical activity among inactive women. Digital technology is evolving at an exponential rate and provides new opportunities to transform research into new approaches to promote physical activity.Trial registrationClinicalTrials.gov NCT01280812; https://clinicaltrials.gov/ct2/show/NCT01280812.International registered report identifier (irrid)RR2-10.1186/1471-2485-11-933.