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An abnormal composition of gut bacteria along with alterations in microbial metabolites and reduced gut barrier integrity has been associated with the pathogenesis of chronic autoimmune and inflammatory rheumatic diseases (AIRDs). The aim of the systematic review, for which this protocol is presented, is to evaluate the clinical benefits and potential harms of therapies targeting the intestinal microbiota and/or gut barrier function in AIRDs to inform clinical practice and future research.
This protocol used the reporting guidelines from the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol. We will search Embase (Ovid), Medline (Ovid) and the Cochrane Library (Central) for reports of randomised controlled trials of patients diagnosed with an AIRD. Eligible interventions are therapies targeting the intestinal microbiota and/or gut barrier function including probiotics, synbiotics, faecal microbiota transplantation, live biotherapeutic products and antibiotics with the intent to modify disease activity in AIRDs. The primary outcome of the evidence synthesis will be based on the primary endpoint of each trial. Secondary efficacy outcomes will be evaluated and selected from the existing core domain sets of the individual diseases and include the following domains: disease control, patient global assessment, physician global assessment, health-related quality of life, fatigue, pain and inflammation. Harms will include the total number of withdrawals, withdrawals due to adverse events, number of patients with serious adverse events, disease flares and deaths. A meta-analysis will be performed for each outcome domain separately. Depending on the type of outcome, the quantitative synthesis will encompass both ORs and standardised mean differences with corresponding 95% CIs.
No ethics approval will be needed for this systematic review. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to disseminate the study results through a peer-reviewed publication.
CRD42025644244.
To explore dietary intake, diet-related challenges in glucose management and perceived needs for dietary support among Swedish adults with type 1 diabetes (T1D).
Cross-sectional observational study based on an electronic survey that included the validated Meal-Q food frequency questionnaire and additional questions on dietary habits and management. Participant characteristics were retrieved from the Swedish National Diabetes Register. Descriptive and correlation analyses were conducted.
Three diabetes specialist clinics in Sweden.
375 adults with T1D.
Dietary intake and diet-related challenges in glucose management.
A total of 191 persons (mean age 48 years; 48% female) consented to participate. The mean (SD) glycated haemoglobin A1c was 56 (13) mmol/mol, mean glucose 8.8 (2.2) mmol/L, time in range (TIR) 64% (18%) and BMI 27 (4.3) kg/m²; 41% used insulin pumps. Mean carbohydrate intake was 183 g/day (41% of energy, E%). Fibre intake was 23 g/day (3.1 g/MJ), and saturated fat intake was 29 g/day (15 E%), both inconsistent with dietary recommendations. About half (51%) found carbohydrate counting challenging, with 53% estimating carbohydrate intake visually and only 18% using advanced methods. Additionally, 48% reported reducing carbohydrate intake, and 61% avoided certain carbohydrate-rich foods due to glucose management difficulties. Approximately 40% of participants reported insufficient dietary guidance from their healthcare providers since diagnosis, 33% expressed interest in further dietitian support and 39% believed dietary changes could improve glucose control.
Participants reported lower fibre intake and higher saturated fat intake compared with dietary guidelines. Many found carbohydrate counting and carbohydrate-rich meals challenging. One-third expressed a wish for additional dietary support. These findings highlight the importance of improving access to tailored dietary counselling in routine T1D care.
The aim was to explore patients’ experiences of ward rounds in inpatient care.
An exploratory qualitative design was chosen, collecting data with one-to-one semistructured interviews, conducted from March to May 2023. An interview guide was used as a basis for the interviews. Data were analysed using reflexive thematic analysis.
A medical and a surgical ward at a medium-sized hospital in southern Sweden.
Purposeful sampling was used to recruit patients aged 18 years or older. 16 patients were recruited with an age range of 38–72 years.
The findings showed that patients’ experiences of ward rounds have a wide range of variation. The main theme was: ‘The ward round as a bridge between patients’ experiences and knowledge and healthcare professionals’. The main theme consisted of two subthemes, reflecting the variation in patients’ experiences: ‘Feeling of togetherness versus loneliness’ and ‘Getting answers or being left in limbo’. The subthemes also highlighted patients’ experiences of factors that enabled satisfactory interactions between patients and healthcare professionals during ward rounds, such as comprehensible detailed information and supportive atmosphere, as well as experiences of factors that obstructed such interactions and caused patients to feel uncertainty.
Ward rounds in inpatient care play an important role for patient care and health, functioning as a bridge between patients and healthcare professionals. It is important for healthcare practitioners and policy-makers to create a model for ward rounds that can contribute to an open and supportive atmosphere as well as sharing comprehensible and detailed information.
To understand participant experience in the INTERLINK-1 clinical trial using the Study Participant Feedback Questionnaire (SPFQ), explore factors associated with participant experience and evaluate the implementation of the SPFQ.
Phase 3, randomised, double-blind, placebo-controlled, multicentre trial.
79 sites in 21 countries from October 2020 to October 2022.
371 adults with recurrent/metastatic head and neck squamous cell carcinoma (39% aged >66 years, 69% White and 81% male).
SPFQ administered at enrolment (SPFQ-A), during the trial (SPFQ-B) and at trial completion (SPFQ-C).
A total of 223, 64 and 93 participants completed the SPFQ-A, SPFQ-B and SPFQ-C, respectively. Early termination of the INTERLINK-1 study limited the number of SPFQ-B and SPFQ-C responses. For all but one question, over 80% of participants selected positive responses, indicating positive experience with regards to enrolment (SPFQ-A), site (SPFQ-B) and overall trial (SPFQ-C). Individually, quality of life, continent and race were significantly associated with participant experience. Small numbers of negative and neutral responses enabled the construction of multiple ordinal regression models and were used to identify unbiased coefficients associated with patient experience. The models showed that males and participants in Asia reported worse experiences in questions regarding trial enrolment (p
Overall, participants reported positive experiences in the INTERLINK-1 study as evaluated by the SPFQ. Specific aspects of participant experience varied by sex, continent, recent adverse events and ECOG status. Further investigation is required to understand the causes of these findings to develop strategies for improved participant experience. Observations from this study will be used to inform future SPFQ implementation and develop strategies for better, more equitable trial experiences.
ClinicalTrials.gov: NCT04590963.
Transvaginal and transabdominal cerclage procedures have become established interventions to prevent mid-trimester pregnancy loss and preterm birth. Transabdominal cerclage seems to be superior to transvaginal cerclage in women with a history of a failed transvaginal cerclage. However, with the availability of a less invasive laparoscopic procedure, there is limited evidence concerning which type of cerclage to recommend to many other risk groups. The objective of this trial is to compare laparoscopic abdominal cerclage and transvaginal cerclage in women at moderate to high risk of spontaneous preterm birth.
The trial is an open, multicentre, superiority, parallel arm randomised controlled investigator-initiated trial with an embedded internal pilot. Women in whom the clinician has clinical equipoise between laparoscopic and transvaginal cerclage are randomised to either laparoscopic abdominal or transvaginal cerclage in a ratio of 1:1. The trial extends from sites in Denmark, Finland and Norway. The primary outcome is birth
The Central Denmark Region Committee on Biomedical Research Ethics, Denmark, Helsinki University Hospital Ethics committee, Finland and the Regional Committees for Medical and Health Research Ethics, Norway approved the trial. This protocol is published prior to complete data collection and analysis. Important protocol changes will be made publicly available on ClinicalTrials.org, on the trial website and distributed electronically to all active sites. Positive, inconclusive as well as negative results from the trial will be published in peer-reviewed international scientific journals.
To extract and interpret quantitative data exploring the effectiveness of family health conversations (FHCs) on family functioning, perceived support, health-related quality of life, caregiver burden and family health in families living with critical or chronic health conditions.
Addressing the health of families affected by critical or chronic illnesses requires focused attention. The effective integration of FHCs is hampered by a scarcity of rigorous quantitative studies that provide solid evidence on best practices and outcomes.
A systematic review following the Joanna Briggs Institute guidelines.
The review is reported according to the PRISMA 2020 checklist. Appropriate studies were searched in PubMed, CINAHL, PsycINFO, Scopus and Cochrane Databases. Results of the search were imported into the Covidence web-based program. Included were studies with a quantitative research design, delivered to families with critical or chronic health conditions, describing FHCs based on the Calgary Family Assessment Model and/or the Calgary Family Intervention Model, and/or the Illness Beliefs Model, using reliable and validated instruments, published between 2008 and 2023, and written in English.
In total, 24 papers met the inclusion criteria. Sixteen papers used a quasi-experimental design, eight of which included a control group. Two papers used a mixed methods design, and six papers were randomised controlled trials (RCTs). A statistically significant effect of FHCs on family functioning was reported in two RCTs and three quasi-experimental papers. We also found that a statistically significant effect of FHCs was reported on perceived support in 9 of 15 papers, quality of life in 4 of 11 papers and caregiver burden in 1 of 3 papers.
The interventions reviewed revealed variability and partial results concerning the effectiveness of FHCs on family functioning. More rigorous research about short-term, intermediate- and long-term effectiveness is needed before conclusions can be drawn.
The study is reported according to the PRISMA 2020 (Preferred Reporting Items for Systematic reviews and Meta-Analyses) (File S1).
No patient or public contribution. Data were gathered from previously published studies.
Alcohol consumption that damages health remains highly prevalent in Sweden despite macrolevel intervention measures such as availability, restrictions and taxation. As understanding of behaviour change develops, there may be an opportunity to enhance individual level interventions by targeting personal dimensions of behaviour, such as underlying motives for drinking alcohol and readiness to change behaviour. This protocol describes a randomised controlled trial aimed at estimating the effectiveness of an intervention tailored to motives and readiness to change.
A three-arm, parallel groups, randomised controlled trial will be used to estimate the effects of a motives and readiness to change tailored intervention. We will use a Bayesian sequential design to decide when to stop recruitment, with target criteria for benefit, harm and futility. Recruitment will be completed via web adverts and social media. Inclusion criteria are being aged 18 or older, having access to a mobile phone and being classified as a risky drinker. Participants allocated to the two intervention groups will receive either a personalised digital intervention or an intervention with enhanced tailoring for motives and readiness to change. The personalised intervention consists of weekly screening, personalised feedback and tools for planning behaviour. The enhanced tailored version will follow the same logic but will contain materials tailored for individuals’ drinking motives and readiness to change. The control group will be redirected to two national websites with information about alcohol and health. Outcome measures are weekly alcohol consumption and monthly heavy drinking episodes, which will be contrasted with regression models and estimated using Bayesian inference.
Ethical approval was obtained from the Swedish Ethical Review Authority on 16 April 2024, (Dnr 2024-01630-01). The results of the study will be disseminated in academic journals and research conferences.
The trial was preregistered in the ISRCTN Registry on 12 June 2024 (ISRCTN87600318).
To identify, appraise and describe the characteristics and measurement properties of instruments assessing Family Focused Care in nursing clinical practice using COSMIN criteria.
A systematic review based on COSMIN methodology.
Methodological quality was assessed using COSMIN methodology and evidence quality using the GRADE approach modified by COSMIN.
The databases PubMed, CINAHL, COCHRANE, Web of Science and SCOPUS were systematically searched from inception until September 2024.
A total of 47 studies and 15 instruments evaluating Family Focused Care were included. Seven were designed for measuring professional's perspective, six for family's and two for both. Three instruments, the Family Nursing Practice Scale (FNPS), the Iceland Family Perceived Support Questionnaire (ICE-FPSQ) and the Perception of Family Centred Care Staff and Parents (PFCC-S/P), exhibited the highest methodological quality and robust psychometric properties, including internal consistency, structural validity, reliability and content validity.
The FNPS, the ICE-FPSQ and the PFCC-S/P questionnaires were identified as the most suitable instruments to assess Family Focused Care. Future research should rigorously evaluate their psychometric properties.
This review provides insight into available instruments for measuring Family Focused Care, helping professionals choose the most suitable tools to enhance family involvement, align care with family needs, and improve patient outcomes and family well-being.
Given that the psychometric properties of instruments measuring Family Focused Care have not been systematically assessed, the present review utilised comprehensive methods according to COSMIN.
No Patient or Public Contribution.
PRISMA statement and COSMIN reporting guideline for studies on measurement properties of patient-reported outcome measures.
This systematic review has been registered at the International Prospective REGISTER of Systematic Review (PROSPERO: CRD42022315249).
To explore the International Network for Child and Family Centred Care (INCFCC) members' experiences and views on the long-term impact of COVID-19 on the nursing workforce.
On the 11 March 2020, the World Health Organization declared COVID-19 a global pandemic. While some countries adopted a herd immunity approach, others imposed stricter measures to reduce the transmission of the virus. Hospitals in some countries faced an avalanche of extremely sick admissions, whereas others experienced an early surge in cases or were able to control the spread.
Discursive paper.
A web-based survey was e-mailed to 63 INCFCC members from 28 March to 30 April 2022, as an invitation to share their experience concerning the long-term impact of COVID-19 on their role as a nurse educator, clinician or researcher.
Sixteen members responded, and the responses were grouped under the themes stress and anxiety, safe staffing and pay, doing things differently, impact on research, impact on teaching and learning, impact on clinical practice, nursing made visible and lessons for the future.
The INCFCC members provided their views and highlighted the impact on their role in nursing education, administration, research and/or practice. This discussion of international perspectives on the similarities and differences imposed by COVID-19 found that the impact was wide-ranging and prolonged. The overarching theme revealed the resilience of the participating members in the face of COVID-19.
This study highlights the importance of all areas of nursing, be it in academia or in clinical practice, to work together to learn from the present and to plan for the future. Future work should focus on supporting organizational and personal resiliency and effective interventions to support the nursing workforce both during a disaster and in the recovery phase. Nursing workforce resilience in the face of COVID-19.
FreshRSS 