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BMJ Open Quality Jul 2024Ambulatory management of congestive heart failure (HF) continues to be a challenging clinical problem. Recent studies have focused on the role of HF clinics, nurse... (Randomized Controlled Trial)
Randomized Controlled Trial
Ambulatory management of congestive heart failure (HF) continues to be a challenging clinical problem. Recent studies have focused on the role of HF clinics, nurse practitioners and disease management programmes to reduce HF readmissions. This pilot study is a pragmatic factorial study comparing a coach intervention, a SMARTPHONE REMINDER system intervention and BOTH interventions combined to Treatment as USUAL (TAU). We determined that both modalities were acceptable to patients prior to randomisation. Fifty-four patients were randomised to the four groups. The COACH group had no readmissions for HF 6 months after enrolment compared with 18% for the SMARTPHONE REMINDER Group, 8% for the BOTH intervention group and 13% for TAU. Medium-to-high medication adherence was maintained in all four groups although sodium consumption was lower at 3 months for the COACH and combined (BOTH) groups. This pilot study suggests a beneficial effect on rehospitalisation with the use of support measures including coaches and telephone reminders that needs confirmation in a larger trial.
Topics: Humans; Heart Failure; Pilot Projects; Male; Female; Reminder Systems; Smartphone; Aged; Middle Aged; Patient Readmission; Medication Adherence
PubMed: 38955396
DOI: 10.1136/bmjoq-2024-002753 -
PloS One 2024Patients experience emotional distress and hold cardiac misconceptions following ST-elevation myocardial infarction. These issues informed the co-production of Cardiac... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Patients experience emotional distress and hold cardiac misconceptions following ST-elevation myocardial infarction. These issues informed the co-production of Cardiac Brief Intervention with patients and clinicians. The current study will establish a knowledge base for the feasibility of delivering this intervention to patients following ST-elevation myocardial infarction, with a preliminary exploration of impact on associated outcomes (ClinicalTrials.gov: NCT05848674).
METHODS
A pilot randomised controlled trial incorporating a mixed-methods design will be conducted. Patients with ST-elevation myocardial infarction (number = 40) will be recruited from coronary care units at two hospital centres in Northern Ireland, with participants randomised (1:1) to the intervention or control group. Cardiac Brief Intervention constitutes a nurse-led, short (20 minutes) emotional and educational support discussion with a patient, with a leaflet that serves as a memory-aid. It will be delivered to the intervention group prior to discharge from a coronary care unit. The control group will receive standard care information. Data will be collected at baseline, post-intervention, 4 weeks from diagnosis, and 14 weeks from diagnosis. Feasibility measurements and process evaluation (quantitative and qualitative) will assess the viability of the research design and intervention delivery. Cardiac rehabilitation attendance data will be collected, and participants will complete questionnaires related to associated outcomes. Quantitative data will be reported with descriptive statistics and qualitative data will be analysed using framework analysis, with data integrated to achieve triangulation of findings.
DISCUSSION
Educational and emotional difficulties following ST-elevation myocardial infarction may impede patient outcomes and cardiac rehabilitation participation. These issues informed the co-production of Cardiac Brief Intervention with patients and clinicians. This study will evaluate the feasibility of delivering Cardiac Brief Intervention to patients. These results will inform large-scale definitive testing of the intervention, which may lead to adoption in clinical practice to improve cardiac rehabilitation uptake and patient outcomes.
Topics: Humans; Pilot Projects; ST Elevation Myocardial Infarction; Feasibility Studies; Male; Female; Middle Aged; Northern Ireland
PubMed: 38954674
DOI: 10.1371/journal.pone.0306406 -
Indian Journal of Public Health Apr 2024Several sporadic cases and outbreaks of Zika virus disease have been reported from different states of India.
BACKGROUND
Several sporadic cases and outbreaks of Zika virus disease have been reported from different states of India.
OBJECTIVES
This paper explored the possibility of any ongoing transmission of Zika virus (ZIKV) in the Bhopal region of Central India, where the last outbreak of this disease was reported in 2018.
MATERIALS AND METHODS
We screened a group of 75 febrile patients who had already tested negative for the locally endemic causes of fever like dengue, chikungunya, enteric fever, malaria, and scrub typhus and two groups of asymptomatic healthy individuals represented by blood donors (n = 75) and antenatal mothers (n = 75). We tested blood samples of febrile patients for ZIKV RNA using real-time polymerase chain reaction (PCR), and for the healthy individuals, we determined anti-zika immunoglobulin G (IgG) antibodies using enzyme-linked immunosorbent assay.
RESULTS
ZIKV RNA was not detected in any of the 75 samples tested by real-time PCR assay. Among the voluntary blood donors and antenatal mothers, a total of 10 (15.38%) and 5 (6.66%) individuals were found to be seropositive for anti-ZIKV IgG antibodies, respectively. The seropositive group was found to have higher age 33.06 (±10.83) years as compared to seronegative individuals 26.60 (±5.12) years (P = 0.037).
CONCLUSION
This study, which is the first survey of seroprevalence of anti-Zika antibodies from India, reports an overall seropositivity rate of 10% for anti-Zika antibodies among the healthy population, suggesting an ongoing, low level, silent transmission of ZIKV in the local community.
Topics: Humans; India; Zika Virus Infection; Seroepidemiologic Studies; Adult; Female; Pilot Projects; Male; Zika Virus; Immunoglobulin G; Young Adult; Antibodies, Viral; Middle Aged; RNA, Viral; Adolescent; Enzyme-Linked Immunosorbent Assay; Real-Time Polymerase Chain Reaction
PubMed: 38953800
DOI: 10.4103/ijph.ijph_1098_23 -
BMC Geriatrics Jul 2024Dietary intervention is an important method to manage sarcopenic obesity, but the implementation in real world is difficult to achieve an ideal condition. This study... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Dietary intervention is an important method to manage sarcopenic obesity, but the implementation in real world is difficult to achieve an ideal condition. This study aimed to the experiences of older people with sarcopenic obesity during the implementation of dietary behavioural change (DBC) intervention.
METHODS
This study is a semi-structured individual interview embedded within a pilot randomized controlled trial on community-dwelling older people with sarcopenic obesity. Purposive sampling was applied to invite 21 participants who had received a 15-week DBC intervention. The interviews were audio-recorded and transcribed verbatim. Content analysis was performed to analyze the data.
RESULTS
The themes for facilitators included: (a) Attach importance to self's health; (b) Family's support; (c) Concern self's body shape; (d) Instructor's support; (e) Regular food diary taken. The themes for barriers included: (a) Difficulties of taking food diary; (b) Difficulties of calculating the food amount; (c) Yield to offspring's appetite; (d) Misjudging self's or family's appetite.
CONCLUSION
Support from family members and instructor, caring about self's health and body image facilitated the intervention implementation. The complication of food amount estimation and diary record, personal sacrifice for next generations, and previous living experience were barriers for implementing the intervention. Overall, the older people with sarcopenic obesity can accept the design of DBC intervention program and have great willing to join.
Topics: Humans; Aged; Female; Male; Obesity; Sarcopenia; Qualitative Research; Feeding Behavior; Aged, 80 and over; Pilot Projects; Independent Living
PubMed: 38951785
DOI: 10.1186/s12877-024-05157-0 -
BMJ Open Jul 2024University students are one of the most vulnerable populations for anxiety disorders worldwide. In Northern Ireland, anxiety disorders appear to be more common among the...
Cerina: cognitive-behavioural therapy-based mobile application for managing GAD symptoms among Ulster University Students in Northern Ireland - a protocol for a pilot feasibility randomised controlled trial.
INTRODUCTION
University students are one of the most vulnerable populations for anxiety disorders worldwide. In Northern Ireland, anxiety disorders appear to be more common among the university student population due to the population demographics across the region. Despite the need, these students show less inclination to access the widely available on-campus well-being services and other external professional services. Digital cognitive-behavioural therapy (CBT) aims to bridge this gap between the need for psychological help and access to it. However, challenges such as limited reach, low adoption, implementation barriers and poor long-term maintenance are mainstay issues resulting in reduced uptake of digital CBT. As a result, the potential impact of digital CBT is currently restricted. The proposed intervention 'Cerina' is a scalable CBT-based mobile app with an interactive user interface that can be implemented in university settings if found to be feasible and effective.
METHODS AND ANALYSIS
The study is a single-blind pilot feasibility randomised controlled trial aiming to test the feasibility and preliminary effects of Cerina in reducing Generalised Anxiety Disorder (GAD) symptoms. Participants are 90 Ulster University students aged 18 and above with self-reported GAD symptoms. They will be allocated to two conditions: treatment (ie, access to Cerina for 6 weeks) and a wait-list control group (ie, optional on-campus well-being services for 6 weeks). Participants in the wait-list will access Cerina 6 weeks after their randomisation and participants in both conditions will be assessed at baseline, at 3 (mid-assessment) and 6 weeks (postassessment). The primary outcome is the feasibility of Cerina (ie, adherence to the intervention, its usability and the potential to deliver a full trial in the future). The secondary outcomes include generalised anxiety, depression, worry and quality of life. Additionally, participants in both conditions will be invited to semistructured interviews for process evaluation.
ETHICS AND DISSEMINATION
Ethical approval for the study has been granted by the Ulster University Research Ethics Committee (ID: FCPSY-22-084). The results of the study will be disseminated through publications in scientific articles and presentations at relevant conferences and/or public events.
TRIAL REGISTRATION NUMBER
NCT06146530.
Topics: Humans; Cognitive Behavioral Therapy; Mobile Applications; Students; Pilot Projects; Feasibility Studies; Northern Ireland; Anxiety Disorders; Universities; Single-Blind Method; Male; Female; Young Adult; Randomized Controlled Trials as Topic; Adolescent; Quality of Life; Adult
PubMed: 38950994
DOI: 10.1136/bmjopen-2023-083554 -
PeerJ 2024Reviewers rarely comment on the same aspects of a manuscript, making it difficult to properly assess manuscripts' quality and the quality of the peer review process. The...
BACKGROUND
Reviewers rarely comment on the same aspects of a manuscript, making it difficult to properly assess manuscripts' quality and the quality of the peer review process. The goal of this pilot study was to evaluate structured peer review implementation by: 1) exploring whether and how reviewers answered structured peer review questions, 2) analysing reviewer agreement, 3) comparing that agreement to agreement before implementation of structured peer review, and 4) further enhancing the piloted set of structured peer review questions.
METHODS
Structured peer review consisting of nine questions was piloted in August 2022 in 220 Elsevier journals. We randomly selected 10% of these journals across all fields and IF quartiles and included manuscripts that received two review reports in the first 2 months of the pilot, leaving us with 107 manuscripts belonging to 23 journals. Eight questions had open-ended fields, while the ninth question (on language editing) had only a yes/no option. The reviews could also leave and . Answers were independently analysed by two raters, using qualitative methods.
RESULTS
Almost all the reviewers ( = 196, 92%) provided answers to all questions even though these questions were not mandatory in the system. The longest answer (Md 27 words, IQR 11 to 68) was for reporting methods with sufficient details for replicability or reproducibility. The reviewers had the highest (partial) agreement (of 72%) for assessing the flow and structure of the manuscript, and the lowest (of 53%) for assessing whether interpretation of the results was supported by data, and for assessing whether the statistical analyses were appropriate and reported in sufficient detail (52%). Two thirds of the reviewers ( = 145, 68%) filled out the section, of which 105 (49%) resembled traditional peer review reports. These reports contained a Md of 4 (IQR 3 to 5) topics covered by the structured questions. Absolute agreement regarding final recommendations (exact match of recommendation choice) was 41%, which was higher than what those journals had in the period from 2019 to 2021 (31% agreement, = 0.0275).
CONCLUSIONS
Our preliminary results indicate that reviewers successfully adapted to the new review format, and that they covered more topics than in their traditional reports. Individual question analysis indicated the greatest disagreement regarding the interpretation of the results and the conducting and the reporting of statistical analyses. While structured peer review did lead to improvement in reviewer final recommendation agreements, this was not a randomized trial, and further studies should be performed to corroborate this. Further research is also needed to determine whether structured peer review leads to greater knowledge transfer or better improvement of manuscripts.
Topics: Pilot Projects; Peer Review, Research; Periodicals as Topic; Humans; Editorial Policies; Peer Review
PubMed: 38948202
DOI: 10.7717/peerj.17514 -
Eastern Journal of Psychiatry 2024Implication of infection in etiology of psychotic disorders is an area of interest.
BACKGROUND
Implication of infection in etiology of psychotic disorders is an area of interest.
AIM
We aimed to explore the relationship between and psychotic disorders in a preliminary study.
MATERIALS AND METHODS
immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies were measured in a sample of patients with psychotic disorders, first-degree relatives (FDR), and healthy volunteers (HV) and compared. Data were analyzed by descriptive statistics in the forms of frequency and percentage using Statistical Package for the Social Sciences (SPSS).
RESULTS
Sample size was 10. Men and women were equal. All were from rural background. One patient with psychotic disorder out of the four had anti- IgG antibodies in comparison to none among the three each of the FDR and HV. The patient with positive IgG antibody status had the diagnosis of acute and transient psychotic disorder (ATPD).
CONCLUSION
This pioneering pilot project from this part of the globe highlights a pertinent area for further work in the future in order to have a newer understanding in proper management of psychotic disorder.
PubMed: 38948105
DOI: 10.5005/jp-journals-11001-0075 -
Journal of Nutritional Science and... 2024The purpose of this study was to examine whether 4 wk of daily ingestion of milk fat globule membrane (MFGM) combined with exercise training improves physical... (Randomized Controlled Trial)
Randomized Controlled Trial
Effects of Milk Fat Globule Membrane Supplementation Following Exercise Training on Physical Performance in Healthy Young Adults: A Randomized Double-Blind, Placebo-Controlled Pilot Trial.
The purpose of this study was to examine whether 4 wk of daily ingestion of milk fat globule membrane (MFGM) combined with exercise training improves physical performance-muscle strength, agility and muscle power-in healthy young adults. The study was designed as a randomized, double-blind, and placebo-controlled trial. Twenty healthy young adults received either an MFGM powder containing 1.6 g of fat and 160 mg of sphingomyelin or an isocaloric placebo powder daily throughout 4 wk of power or agility training. Physical performance tests and body composition measurements were conducted before and after the 4-wk intervention. Ingestion of MFGM did not affect isometric or isokinetic muscle strength, but it was associated with a greater increase in vertical jump peak power compared with placebo. There were no significant changes in body weight or lean body mass during the intervention period in either group, and no significant differences between groups. We conclude that daily MFGM supplementation combined with exercise training has the potential to improve physical performance in young adults; however, further studies with larger sample sizes should be conducted to obtain more evidence supporting achievement of improved physical performance through MFGM supplementation.
Topics: Humans; Double-Blind Method; Glycolipids; Lipid Droplets; Glycoproteins; Male; Young Adult; Female; Dietary Supplements; Muscle Strength; Body Composition; Exercise; Pilot Projects; Adult; Physical Functional Performance; Body Weight; Sphingomyelins; Muscle, Skeletal
PubMed: 38945893
DOI: 10.3177/jnsv.70.273 -
Journal of Gastrointestinal and Liver... Jun 2024Ultra-microangiography (UMA) is a novel Doppler technique with optimized wall filtering that provides high sensitivity to low-velocity blood flows and optimized... (Comparative Study)
Comparative Study
BACKGROUND AND AIMS
Ultra-microangiography (UMA) is a novel Doppler technique with optimized wall filtering that provides high sensitivity to low-velocity blood flows and optimized visualization of microcirculation. The aim of this pilot study was to compare intestinal vascularization assessed by color Doppler signals (CDS) and UMA.
METHODS
We investigated intestinal vascularization using UMA and CDS in 13 patients with confirmed inflammatory bowel disease (IBD). A cohort of 28 patients without structural bowel disease served as the control.
RESULTS
Microcirculation and dysregulated microcirculation in patients without and with inflammatory bowel disease can be visualized and quantified using UMA. In 83 % of IBD patients and 76% of non-IBD patients, a high resolution of intestinal perfusion could be achieved using UMA.
CONCLUSIONS
To the best of our knowledge, this is the first study to investigate intestinal vascularization using UMA in patients with and without structural bowel disease. Quantification and visualization of intestinal vascularization should be further investigated in prospective studies and could help guide our therapy of patients with IBD.
Topics: Humans; Pilot Projects; Microcirculation; Female; Male; Adult; Middle Aged; Intestines; Inflammatory Bowel Diseases; Ultrasonography, Doppler, Color; Angiography; Aged; Young Adult; Predictive Value of Tests; Case-Control Studies
PubMed: 38944869
DOI: 10.15403/jgld-5495 -
BMC Medical Informatics and Decision... Jun 2024This paper outlines the design, implementation, and usability study results of the patient empowerment process for chronic disease management, using Patient Reported...
INTRODUCTION
This paper outlines the design, implementation, and usability study results of the patient empowerment process for chronic disease management, using Patient Reported Outcome Measurements and Shared Decision-Making Processes.
BACKGROUND
The ADLIFE project aims to develop innovative, digital health solutions to support personalized, integrated care for patients with severe long-term conditions such as Chronic Obstructive Pulmonary Disease, and/or Chronic Heart Failure. Successful long-term management of patients with chronic conditions requires active patient self-management and a proactive involvement of patients in their healthcare and treatment. This calls for a patient-provider partnership within an integrated system of collaborative care, supporting self-management, shared-decision making, collection of patient reported outcome measures, education, and follow-up.
METHODS
ADLIFE follows an outcome-based and patient-centered approach where PROMs represent an especially valuable tool to evaluate the outcomes of the care delivered. We have selected 11 standardized PROMs for evaluating the most recent patients' clinical context, enabling the decision-making process, and personalized care planning. The ADLIFE project implements the "SHARE approach' for enabling shared decision-making via two digital platforms for healthcare professionals and patients. We have successfully integrated PROMs and shared decision-making processes into our digital toolbox, based on an international interoperability standard, namely HL7 FHIR. A usability study was conducted with 3 clinical sites with 20 users in total to gather feedback and to subsequently prioritize updates to the ADLIFE toolbox.
RESULTS
User satisfaction is measured in the QUIS7 questionnaire on a 9-point scale in the following aspects: overall reaction, screen, terminology and tool feedback, learning, multimedia, training material and system capabilities. With all the average scores above 6 in all categories, most respondents have a positive reaction to the ADLIFE PEP platform and find it easy to use. We have identified shortcomings and have prioritized updates to the platform before clinical pilot studies are initiated.
CONCLUSIONS
Having finalized design, implementation, and pre-deployment usability studies, and updated the tool based on further feedback, our patient empowerment mechanisms enabled via PROMs and shared decision-making processes are ready to be piloted in clinal settings. Clinical studies will be conducted based at six healthcare settings across Spain, UK, Germany, Denmark, and Israel.
Topics: Humans; Decision Making, Shared; Patient Reported Outcome Measures; Patient Participation; Chronic Disease; Empowerment
PubMed: 38943152
DOI: 10.1186/s12911-024-02588-y