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Ethics approval and consent to participate | The study was approved by Ethics Committee in Central Denmark Region (j.no. 64207). All participants gave informed consent to participate. The study was monitored by the GCP unit at Aarhus and Aalborg University Hospitals, Denmark. | PMC10601301 | ||
Consent for publication | Not applicable. | PMC10601301 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10601301 | ||
References | PMC10601301 | |||
Background | mental disorders | Intimate and romantic relationships are important in life for individuals, irrespective of mental health status. We developed a four-hour peer-led learning program for persons with mental disorders about intimate and romantic relationships through a co-creation process with service users and examined its preliminary ef... | PMC10588039 | |
Methods | mental disorders | A one-group pretest–posttest trial was conducted using a mixed-method design for 45 individuals with mental disorders in Japan. Outcome data were collected at three time points: baseline, post-intervention, and one month after program completion. Mixed models for repeated measures (MMRM) were used to examine changes ov... | PMC10588039 | |
Results | psychiatric | MMRM showed significant changes over time on RSES, RAS, HHI, and two original items “I am able to communicate well with others about myself” and “I am able to listen to others well.” In multiple comparisons, RSES and HHI were significant one month after the program. Participants reported changes during the first month ... | PMC10588039 | |
Conclusions | The program exhibited preliminary effectiveness to a moderate extent in improving recovery, particularly regarding self-esteem and hope. The program is feasible but requires further modifications regarding inclusion criteria for participants and the training of peer facilitators. | PMC10588039 | ||
Trial registration | UMIN000041743;09/09/2020. | PMC10588039 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12888-023-05254-1. | PMC10588039 | ||
Keywords | PMC10588039 | |||
Background | fatigue, anxiety, psychosis, cognitive problems, mental disorders, depression | The concept of In a systematic review of 20 studies of persons who experienced psychosis, 15% of participants were married [For persons with psychosis, symptoms such as anxiety, depression, cognitive problems, and fatigue due to mental exhaustion can be barriers to initiating and engaging in romantic relationships, giv... | PMC10588039 | |
Process of program development | mental disorders | The program was developed with peers with mental disorders (peer collaborators) involved in all four processes in the co-creation of new knowledge [The first process is “co-ideation,” which involves engaging in open dialogue to share new and creative ideas for solving problems related to new programs [Second, the proce... | PMC10588039 | |
Methods | PMC10588039 | |||
Design | A one-group pretest–posttest trial was conducted using a mixed-method design. Participants were assessed for outcomes using self-administered questionnaires at baseline (T1), post-intervention (T2; the day after T1), and one month after program completion (T3). The paper questionnaires were distributed and collected by... | PMC10588039 | ||
Program description | mental disorders | The program was named AIRIKI (“the power to love” in Japanese). This program offers essential elements for overcoming barriers related to forming and maintaining of intimate and romantic relationships among those with mental disorders. The program does not aim to provide knowledge per se but to enhance participants’ ow... | PMC10588039 | |
Study participants | psychiatric, a mental disorder | Participants comprised adults (20 years of age or older) who met all of the following criteria: (1) diagnosed with a mental disorder and currently undergoing psychiatric outpatient treatment; (2) psychiatrist’s determination that the patients’ psychiatric symptoms were stable enough to allow participation in the study;... | PMC10588039 | |
Program implementation | Information on program implementation was widely publicized through the program’s website, e-mail lists, social networking services of several mental health self-help groups, and flyer distribution. Once we received a call from a potential participant, we planned an intervention near where the person lived, and distrib... | PMC10588039 | ||
Outcome measures | To measure the program’s objective of promoting recovery, the Rosenberg Self-Esteem Scale (RSES), Recovery Assessment Scale (RAS), and Herth Hope Index (HHI) were used as outcome measures. The RSES and HHI measure the major components of the concept of recovery [ | PMC10588039 | ||
Rosenberg self-esteem scale (RSES) | The RSES is a self-report scale that measures self-esteem. The validity and reliability of the Japanese version have been confirmed [ | PMC10588039 | ||
Recovery assessment scale (RAS) | mental disorders | The RAS is a self-report scale that measures the recovery process of persons with mental disorders using a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher total scores indicate being further along in the process of recovery, and the reliability and validity of the 24-item Japane... | PMC10588039 | |
Herth hope index (HHI) | The HHI is a self-report scale that measures levels of hope. The validity and reliability of the Japanese version have been confirmed [ | PMC10588039 | ||
Process evaluation measures | Process evaluation was conducted using originally developed items and interviews. We developed eleven items on relationships with significant others that were relevant to program content with input from peer collaborators. Peers felt it was important to determine if there were any changes in these process dimensions. F... | PMC10588039 | ||
Feasibility evaluation measures | Feasibility was determined by subjective ratings of satisfaction with the program and whether they thought it would help them in their lives, as well as by any negative effects of the program. Specifically, unscheduled visits to the psychiatrist up to one month after completion of the program (T3 questionnaire), the nu... | PMC10588039 | ||
Analysis | T1–T3 | The dataset included all participants who provided data at T1. Baseline characteristics are summarized as means and standard deviations for continuous variables and frequencies and proportions for categorical variables. For the outcome measures and process evaluation measures, we first compared the means of the three t... | PMC10588039 | |
Results | PMC10588039 | |||
Study participants | Figure
Flow of study participants | PMC10588039 | ||
Baseline characteristics of study participants | ASD, Autism, congenital disabilities, ADHD, Attention-Deficit/Hyperactivity Disorder, intellectual disabilities | Table
Demographic data of participantsASD: Autism Spectrum DisorderADHD: Attention-Deficit/Hyperactivity Disorder* Excluding congenital disabilities (ASD and/or ADHD and mild intellectual disabilities) | PMC10588039 | |
Quantitative analyses | PMC10588039 | |||
Effectiveness over time | As shown in Table
Outcome and process evaluation measuresMMRM: A mixed model for repeated measures with time points (T1, T2, and T3) as fixed effects and program sites as random effectsPaired t-test: multiple comparison test using Bonferroni correctionCohen’s d coefficients were calculated considering correlation coef... | PMC10588039 | ||
Process evaluation | As shown in Table | PMC10588039 | ||
Feasibility evaluation | Regarding program satisfaction, 29 (69.0%) were “very satisfied,“ 12 (28.6%) were “fairly satisfied,“ and 1 (2.4%) was “not very satisfied”; notably, 0 (0.0%) reported “not satisfied at all.” As for whether they thought it would be useful in their lives, 29 (69.0%) thought it would be “very useful,“ 11 (26.2%) thought ... | PMC10588039 | ||
Qualitative analyses | PMC10588039 | |||
Process evaluation | illness | Interview data from one month after program participation were analyzed to determine what was impressive about the program (Table
Positively impressive components of program
Qualitative findings of changes after programAs shown in Table In Module 1, the most common response was the focus on “love and romance” (n = 9) ... | PMC10588039 | |
Feasibility evaluation | Nine participants reported negative changes in their condition and/or feelings during and up to one month after participation in the program [Additional File | PMC10588039 | ||
Discussion | mental disorders | We developed a peer-led learning program on intimate and romantic relationships aimed at promoting recovery in persons with mental disorders. This section discusses implications of the preliminary effectiveness and feasibility of the program. | PMC10588039 | |
Study participants | disability, mental disabilities | Although the study participants had a variety of primary illnesses, all but four were using disability services, indicating that most had some disability in their daily and social lives. However, 21 (46.7%) were working without support and 18 (40.0%) were living alone. According to a national survey of people with disa... | PMC10588039 | |
Effectiveness of the program | SAID | This program was found to be associated with significant changes over time in self-esteem, comprehensive recovery, and a sense of hope; however, not all had high effect sizes. Comprehensive recovery showed significant effects after immediately attending the program; however, self-esteem and sense of hope were significa... | PMC10588039 | |
Feasibility of the program | mental disorders, unstable psychiatric symptoms, psychiatric | EVENTS | In terms of program satisfaction and usefulness in life, the positive ratings were more than 95%. Therefore, we believe that this program meets the needs of the participants, although some of the participants experienced negative consequences. Two participants had an unscheduled psychiatric visit, and seven people repo... | PMC10588039 |
Study limitations and future research | The first limitation of this study is that it was not an RCT, but a one-group pretest-posttest design. Therefore, we cannot rule out the possibility of other factors affecting the changes in outcomes. Second, the program facilitators received two days of training to conduct the program; however, most of them did not ha... | PMC10588039 | ||
Conclusion | psychiatric | This peer-led learning program on intimate and romantic relationships was effective to a moderate extent in improving recovery, especially in increasing self-esteem and enhancing hope. Two participants had unscheduled psychiatric visits that may have been due to their participation in the program, but all recovered aft... | PMC10588039 | |
Acknowledgements | We thank all participants, peer facilitators, and peer collaborators. | PMC10588039 | ||
Authors’ contributions | Design of the study: MK, KY, KI, SN, RH, and PS; development of the program: MK, KY, KI, SN, PS; analysis: MK, MN, RO; data management: MK, MN, and RO; and manuscript preparation: MK. PS. All the authors have reviewed and confirmed the final manuscript prior to submission. | PMC10588039 | ||
Funding | JP | This study was supported by the Japan Society for the Promotion of Science (JSPS) KAKENHI (grant number JP 19H03960, JP 23H03226). | PMC10588039 | |
Data Availability | Access to the rules for participation and facilitation of this program was made openly available ( | PMC10588039 | ||
Declarations | PMC10588039 | |||
Conflict of interest | The authors declare that they have no conflicts of interest. | PMC10588039 | ||
Ethical approval and consent to participate | ADVERSE EVENTS | This study was approved by the Ethics Committee for the Intervention Study of Osaka University Hospital (approval no. 19315; 14/04/2020, revised design approval 14/04/2021). This study was conducted in accordance with the principles of the Declaration of Helsinki. This project was registered in the Clinical Trial Regis... | PMC10588039 | |
Consent for publication | Not applicable. | PMC10588039 | ||
References | PMC10588039 | |||
Purpose | COPD | CHRONIC OBSTRUCTIVE PULMONARY DISEASE, COPD, ADVERSE DRUG REACTIONS | Inhaled drugs have been cornerstones in the treatment of chronic obstructive pulmonary disease (COPD) for decades and show a high prescription volume. Due to the local application, drug safety issues of these therapies are often underestimated by professionals and patients. Data about adverse drug reactions (ADRs) caus... | PMC9879805 |
Methods | EMERGENCY | Emergency department cases due to suspected ADRs of the ADRED database ( | PMC9879805 | |
Results | COPD | COPD | Of the 269 included COPD cases, 67% ( | PMC9879805 |
Conclusion | COPD | COPD | Overdosed inhaled therapies in patients with COPD lead to relevant ADRs and impact on emergency room presentations. These are rarely associated to inhaled therapy by healthcare professionals or patients. Due to the high volume of inhaled drug prescriptions, pharmacovigilance and patient education should be more focused... | PMC9879805 |
Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC9879805 | ||
Introduction | COPD | COPD, LUNG DISEASES, CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Chronic obstructive pulmonary disease (COPD) is one of the most common lung diseases with a prevalence between 9 and 19% in the age groups over 60 years [Along with a higher prevalence of COPD in older adults, these patients are more often affected by polypharmacy [Most data on treatment safety in COPD focus on the cor... | PMC9879805 |
Methods | PMC9879805 | |||
Study population | COPD | COPD, ADVERSE DRUG REACTIONS, EMERGENCY | Hospital ED admissions due to ADRs in patients with COPD were extracted from the national, multicenter, prospective observational study “ADRED” (“Adverse Drug Reactions in Emergency Departments”; DRKS-ID: DRKS00008979, registration date 01/11/2017, ethical approval 202/15; University of Bonn). This study serves to pros... | PMC9879805 |
Data collection | COPD, overdosed | COPD | ADR cases with a prior diagnosis of COPD (ICD-10: J44) were extracted from the ADRED data, irrespective of the reason of presentation to the ED. Hence, all cases documented presented with an at least possible ADR. From these cases, demographic and general clinical data such as current medication use, previous diagnoses... | PMC9879805 |
Statistical evaluation | overdose, COPD, overdosed | REGRESSION, COPD | COPD cases were analyzed descriptively. Continuous parameters were tested for normal distribution using the Kolmogorov–Smirnov test. Non-normally distributed parameters were reported as median and interquartile range (IQR) and compared using Mann–Whitney test between cases with overdosed inhaled therapy and non-overdos... | PMC9879805 |
Discussion | dyspnea, overdose, CHD, overdosed, COPD | COPD, ADVERSE EFFECTS, CHRONIC HEART FAILURE | The present study shows that ADR symptoms associated with the use of inhaled therapy are prominent in patients that are overdosed compared to non-overdosed patients with COPD. This effect is seen irrespective of the reason leading to the presentation in the hospital ED. Thereby, 16% of all prescribed inhaled therapies ... | PMC9879805 |
Conclusion | adverse drug reactions, COPD | COPD, ADVERSE DRUG REACTIONS | Inhaled therapies in patients with COPD taken beyond the intended dosage regimen lead to the development of relevant adverse drug reactions and impact to presentations in German emergency departments. Due to the overall high prescription volume of inhaled medications, pharmacovigilance, patient education, and patient i... | PMC9879805 |
Acknowledgements | PD, Thomas | EMERGENCY | The data were provided by the centers involved in the ADRED study; Central Emergency Department of Fürth Hospital (Prof. Dr. med. Harald Dormann), Internal Medicine Emergency Center of Ulm University Hospital (Prof. Dr. med. Thomas Seufferlein), Interdisciplinary Emergency Center INZ of Bonn University Hospital (PD Dr.... | PMC9879805 |
Author contribution | IB conducted the analyses and drafted the manuscript. KJ add MD supported the data extraction and analysis. JS and CS designed the ADRED study and supervised all analyses and coordination. | PMC9879805 | ||
Funding | Open Access funding enabled and organized by Projekt DEAL. The ADRED study was funded by the framework of the AMTS focus of the German Federal Ministry of Health (BMG), grant number ZMVI5–2514ATA004. This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agr... | PMC9879805 | ||
Data availability | The datasets analyzed during the current study are available from the corresponding author on reasonable request. | PMC9879805 | ||
Declarations | PMC9879805 | |||
Ethical approval | The study was approved by the responsible ethical committee of the University of Bonn (202/15). | PMC9879805 | ||
Informed consent | Informed consent was obtained from individual participants included in the study described in the manuscript. | PMC9879805 | ||
Consent for publication | Not applicable. | PMC9879805 | ||
Competing interests | The authors declare no competing interests. | PMC9879805 | ||
References | PMC9879805 | |||
Subject terms | weight gain, metabolic syndrome, diet-induced obese | METABOLIC SYNDROME, BLIND | Bacteriophages (phages) are bacterial viruses that have been shown to shape microbial communities. Previous studies have shown that faecal virome transplantation can decrease weight gain and normalize blood glucose tolerance in diet-induced obese mice. Therefore, we performed a double-blind, randomised, placebo-control... | PMC10497675 |
Introduction | metabolic syndrome | METABOLIC SYNDROME, INSULIN SENSITIVITY | The metabolic syndrome (MetSyn) constitutes a major global health concernPreviously reported microbial effects on human health have been mainly attributed to the bacterial component of the microbiotaConsidering their ability to modulate gut bacteria and their functionModulation of gut microbiota composition through FMT... | PMC10497675 |
Results | PMC10497675 | |||
Inclusion of subjects and donors | To study whether an FFT could induce a similar effect on glucose metabolism as an FMT, we set up a prospective double-blind, randomised, placebo-controlled pilot study (Fig. | PMC10497675 | ||
Bacterial and viral diversity remain stable after FFT | To assess the effect of the FFT on the bacteriome and phageome, we collected multiple faecal samples from baseline up to day 28, and performed whole genome shotgun (WGS) sequencing (Fig. | PMC10497675 | ||
Increase in new phages independent of the intervention | Since we expected transfer of donor phages to the recipients, we looked at the abundance of phages shared between donor and recipient before and after the FFT. Although not significant, after FFT the VPs shared with the donor within the WGS phageome increased up to day 14 ( | PMC10497675 | ||
FFT alters the phage composition of the VLP fraction | Subsequently, we looked at compositional changes within the bacteriome, WGS phageome and VLP phageome (Fig. | PMC10497675 | ||
FFT induces an antagonistic phage-microbe interaction | Intrigued by the presence of differentially abundant VPs two days after FFT, we determined whether the dynamics between phages and their microbial hosts had changed. For this, we linked VPs to metagenome-assembled genomes (MAGs) from our WGS sequencing dataset and calculated the mean abundance change for all VP-MAG pai... | PMC10497675 | ||
Discussion | diet-induced obese, weight gain, gastrointestinal adverse | LYSING, STERILE, DISEASE | In this randomised controlled clinical trial we administered a sterile faecal filtrate from healthy donors to human individuals with MetSyn. The FFT was well-tolerated and safe, with recipients experiencing solely mild gastrointestinal adverse effects. As the study group is small, larger studies with a longer follow-up... | PMC10497675 |
Methods | PMC10497675 | |||
Study design | STERILE | We set up a prospective, double-blinded, randomised, placebo-controlled intervention study that was performed in our academic hospital, the Amsterdam University Medical Centres location AMC in the Netherlands. After passing screening, 24 subjects with MetSyn were randomised to receive a sterile FFT from a lean healthy ... | PMC10497675 | |
Study subjects | overweight | Study participants were all European Dutch, overweight (body mass index (BMI) ≥ 25 kg/m | PMC10497675 | |
Donor screening | Faeces donors were lean healthy European Dutch subjects who were thoroughly screened according to the guidelines of the European FMT Working Group | PMC10497675 | ||
Sterile faecal filtrate production and administration | STERILE, -20 | Production of the sterile faecal filtrate started the day before administration to the MetSyn subjects. First, 50 g of stool was collected from a screened donor, which was homogenised with 500 ml sterile saline. Large particles were filtered from the faecal suspension using double sterile gauzes. Most of the bacteria w... | PMC10497675 | |
Outcomes | ADVERSE EVENTS, INFLAMMATION, SECONDARY | The primary outcome was change in glucose metabolism, as determined by the AUC for glucose excursion during the OGTT. Secondary outcomes related to glucose metabolism were changes in fasting glucose, insulin, HOMA-IR and HbA1c between baseline and follow-up after 28 days, as well as changes in glucose variability measu... | PMC10497675 | |
Sample size calculation | Based on previous data from our group in which individuals with MetSyn received an FMT | PMC10497675 | ||
Randomisation | Data were captured with electronic case report forms build in Castor EDC (v2019.2.0-2020.2.25) | PMC10497675 | ||
Oral glucose tolerance test and biochemical measurements | BLOOD, INFLAMMATION | For the OGTT, overnight fasted subjects ingested a standardised glucose solution (75 g). Blood was drawn from an intravenous catheter at baseline and 15, 30, 45, 60, 90 and 120 min after ingestion. Both blood serum and plasma were aliquoted and stored at −80 °C. From these aliquots we measured glucose and C-peptide, wh... | PMC10497675 | |
Continuous glucose monitoring | To reduce the study burden and prevent daily finger pricks, we used a continuous glucose monitoring device (Freestyle Libre 1) to monitor blood glucose, which allowed subjects to perform all normal activities while wearing the sensor. Subjects were taught to subcutaneously implant the CGM sensor and were instructed to ... | PMC10497675 | ||
Faeces collection | The day before the intervention and 2, 4, 7, 14 and 28 days thereafter, subjects were asked to collect several faecal samples. Faeces were collected by participant in stool collection tubes, which were directly stored in a freezer at home inside a safety bag. In addition, participants registered the time, date and cons... | PMC10497675 | ||
Bacteriome and virome sequencing | To study the bacteriome and virome, we performed whole genome shotgun (WGS) sequencing. From the stored frozen faeces samples, total genomic DNA was extracted using a repeated bead beating method as described previously | PMC10497675 | ||
VLP sequencing | To study phage virions, we isolated the faecal VLP fraction and sequenced dsDNA phages as previously described | PMC10497675 | ||
Sequence assembly | Sequencing resulted in an average of 21.7 ± 3.5 M reads per WGS sample (median: 22.4 M reads), and 23.6 ± 18.3 M per VLP sample (median: 18.1 M reads). Before assembly, reads belonging to the same participant were concatenated. Adapter sequence removal and read trimming were performed with fastp v0.23.2 (option –detect... | PMC10497675 | ||
Viral sequence recognition and clustering | To identify viral sequences among the WGS and VLP assemblies, contigs longer than 5000 bp were analysed with virsorter v2.2.3 | PMC10497675 | ||
Viral read depth determination | Viral relative abundance was determined by mapping high-quality reads from each sample (i.e., one mapping per participant and time-point) against non-redundant viral sequences with bowtie2 v2.4.2 | PMC10497675 | ||
Bacterial community profiling and binning | Bacterial population compositions of WGS samples were profiled per participant and time point with mOTUs v3.0.3 | PMC10497675 | ||
Determining phage-host links | Viral sequences were linked to bacterial MAGs in two ways. Firstly, if a viral contig was contained within a MAG, it was considered to be a prophage. Secondly, viral contigs were linked to MAGs using CRISPR spacer hits. For this, CRISPR spacer arrays were identified among MAGs using CRISPCasFinder v4.2.20 | PMC10497675 | ||
Statistical analyses | All statistical analyses were performed in R v4.2.1. Richness, α-diversities, principal component analysis (PCA), and principal response curves (PRC) were all calculated with the vegan R package v2.6-4 | PMC10497675 |
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