Prospectively investigating the impact of AI onshared decision-making in post kidney transplant care (PRIMA-AI): protocol for a longitudinal qualitative study among patients, their support persons and treating physicians at a tertiary care centre

Introduction
As healthcare is shifting from a paternalistic to a patient-centred approach, medical decision making becomes more collaborative involving patients, their support persons (SPs) and physicians. Implementing shared decision-making (SDM) into clinical practice can be challenging and becomes even more complex with the introduction of artificial intelligence (AI) as a potential actant in the communicative network. Although there is more empirical research on patients’ and physicians’ perceptions of AI, little is known about the impact of AI on SDM. This study will help to fill this gap. To the best of our knowledge, this is the first systematic empirical investigation to prospectively assess the views of patients, their SPs and physicians on how AI affects SDM in physician–patient communication after kidney transplantation. Using a transdisciplinary approach, this study will explore the role and impact of an AI-decision support system (DSS) designed to assist with medical decision making in the clinical encounter.

Methods and analysis
This is a plan to roll out a 2 year, longitudinal qualitative interview study in a German kidney transplant centre. Semi-structured interviews with patients, SPs and physicians will be conducted at baseline and in 3-, 6-, 12- and 24-month follow-up. A total of 50 patient–SP dyads and their treating physicians will be recruited at baseline. Assuming a dropout rate of 20% per year, it is anticipated that 30 patient–SP dyads will be included in the last follow-up with the aim of achieving data saturation. Interviews will be audio-recorded and transcribed verbatim. Transcripts will be analysed using framework analysis. Participants will be asked to report on their (a) communication experiences and preferences, (b) views on the influence of the AI-based DSS on the normative foundations of the use of AI in medical decision-making, focusing on agency along with trustworthiness, transparency and responsibility and (c) perceptions of the use of the AI-based DSS, as well as barriers and facilitators to its implementation into routine care.

Ethics and dissemination
Approval has been granted by the local ethics committee of Charité—Universitätsmedizin Berlin (EA1/177/23 on 08 August 2023). This research will be conducted in accordance with the principles of the Declaration of Helsinki (1996). The study findings will be used to develop communication guidance for physicians on how to introduce and sustainably implement AI-assisted SDM. The study results will also be used to develop lay language patient information on AI-assisted SDM. A broad dissemination strategy will help communicate the results of this research to a variety of target groups, including scientific and non-scientific audiences, to allow for a more informed discourse among different actors from policy, science and society on the role and impact of AI in physician–patient communication.

Leggi
Ottobre 2024

Progress and scenario-based projections of health service availability and coverage towards UHC in the post-conflict and post-pandemic Iraq: a Bayesian hierarchical regression approach

Background
Two decades have passed since the beginning of the Iraq War in 2003. Iraq has long suffered from conflicts and instability, where the people have limited access to healthcare. The coronavirus disease (COVID-19) pandemic brought additional disruption to health service provision.

Objectives
At the midpoint towards universal health coverage (UHC) in 2030, this study aims to gain a better understanding of the trends of UHC progress in Iraq in the context of the conflicts and the COVID-19 pandemic and to indicate possible pragmatic options.

Design
This study employed Bayesian hierarchical regression models to estimate trends and projections of health service availability and coverage indicators up to 2030. Furthermore, for health service coverage, four scenarios were defined based on the availability of health services, and projections were made for each scenario up to 2030.

Setting
Our approach used the yearly data from the Ministry of Health and four nationally representative household surveys between 2000 and 2020. We evaluated the subnational-level progress in three health service availability indicators and 13 health service coverage indicators in 18 governorates in Iraq from 2000 to 2030.

Results
The findings from 2000 to 2020 revealed a lack of progress in the indicators of health facility and inpatient bed, and pronounced detrimental effects from major conflicts and the pandemic on all measured health service coverage indicators. Despite these setbacks, several health service coverage indicators demonstrated resilience and elasticity in their recovery. The projected trends for 2021 to 2030 indicated limited alternations in the health service availability. By 2030, five health service coverage indicators will achieve the designated 80% targets. A scenario-based analysis predicts improved coverage of antenatal care, and child immunisation and treatment if health service availability is bolstered to globally recommended standards. Under this scenario, several governorates—Anbar, Baghdad, Nainawa, Qadissiyah, Salahaddin, Thiqar and Wasit—presented improved health service coverage in more indicators.

Conclusion
Strengthened health service availability has the potential to significantly improve fragile health service coverage indicators and in more vulnerable governorates.

Leggi
Ottobre 2024

Impact of increasing post-filter ionised calcium target on regional citrate anticoagulation efficacy in ICU continuous renal replacement therapy: the non-inferiority randomised controlled Ca-CIBLE protocol

Introduction
Continuous renal replacement therapy (CRRT) is a critical therapeutic intervention for patients with severe acute kidney injury in intensive care. However, premature filter clotting remains a significant challenge during CRRT, impacting treatment efficacy, costs and patient outcomes. Anticoagulation is essential to maintain circuit patency, with regional citrate anticoagulation (RCA) emerging as a preferred strategy due to its favourable bleeding profile. The standard target for post-filter ionised calcium (iCa) concentration during RCA-CRRT is set between 0.25 and 0.35 mmol/L, although evidence supporting this range is limited. We hypothesise that a higher post-filter iCa target (0.35–0.45 mmol/L) can provide comparable circuit patency while potentially reducing adverse effects associated with citrate administration.

Methods and analysis
This multicentre randomised controlled non-inferiority trial will compare a low post-filter iCa target (0.25–0.35 mmol/L) with a higher post-filter iCa target (0.35–0.45 mmol/L) in patients undergoing RCA-CRRT in the intensive care unit. A total of 412 CRRT sessions will be randomised with a 1:1 ratio into these two groups. The primary outcome is the incidence of filter clotting. Secondary outcomes include filter lifespan, post-filter iCa levels, citrate infusion rates, the occurrence of metabolic adverse effects, financial costs and blood loss.

Ethics and dissemination
The study has obtained approval from the ethics committee (Ethics Committee Est III, Nancy, France) and patients will be included after providing informed consent. The results will be disseminated at academic conferences and in peer-reviewed publications. All procedures were developed in order to assure data protection and confidentiality.

Trial registration number
NCT05814341.

Leggi
Settembre 2024

What is known about nurse retention in peri-COVID-19 and post-COVID-19 work environments: protocol for a scoping review of factors, strategies and interventions

Introduction
The pandemic has highlighted a worsening of nurses’ working conditions and a global nursing shortage. Little is known about the factors, strategies and interventions that improve nurse retention in the peri-COVID and post-COVID time period. An improved understanding of approaches implemented to support and retain nurses will provide a blueprint for sustaining the nursing workforce. The objectives of this scoping review are to investigate and describe the following: (a) factors associated with nurse retention; (b) strategies suggested to support nurse retention and (c) interventions trialled to support nurse retention, during and after the COVID-19 pandemic.

Methods and analysis
Medline, Embase, CINAHL and Scopus will be searched. The included studies will be qualitative, quantitative, mixed methods and grey literature studies of nurses including factors, strategies and/or interventions to support nurse retention in the peri-COVID and post-COVID time period (2019 to present) that are in English or can be translated into English. The excluded studies will be those that focus on nurse managers, educators, students or those in advanced practice roles and studies where the population cannot be segmented to identify which data came from nurses. Systematic, scoping reviews and meta-syntheses will be excluded, but their reference lists will be hand-screened for suitable studies. Data will be evaluated for quality and synthesised qualitatively to map the current evidence available. The relevant studies will be reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.

Ethics and dissemination
Approval for the broader research study, including this scoping review, has been obtained from the university health sciences research board (protocol #00042510). All data for this scoping review will be collected from published literature, and findings will be published in a peer-reviewed journal and presented at relevant conferences.

Trial registration number
The protocol was registered on Open Science Framework (4 April 2024) https://doi.org/10.17605/OSF.IO/XWH45.

Leggi
Settembre 2024

Clinical efficacy and therapeutic mechanism of active 'five-tone speech therapy compared with conventional speech-language therapy for treatment of post-stroke aphasia: protocol for a randomised controlled trial

Introduction
Aphasia is a common dysfunction among patients with stroke that can severely affect daily life. Listening to the ‘five-tone’ melodies of traditional Chinese medicine can improve some of the language functions of patients with post-stroke aphasia; however, passive listening may limit its clinical efficacy. In this study, we transform the passive listening five-tone melodic therapy of traditional Chinese medicine into an active five-tone speech therapy. This randomised controlled trial aims to investigate the clinical efficacy of active five-tone speech therapy in the treatment of post-stroke aphasia, such as language function, daily communication ability and communication efficiency, as well as investigate the therapeutic mechanism of this innovative therapy by electroencephalogram and MRI.

Methods and analysis
The study is a multicentric, randomised, parallel-assignment, single-blind treatment study. 70 participants will be recruited from the Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine and the Third People’s Hospital Affiliated to Fujian University of Traditional Chinese Medicine and randomly assigned to two groups, the five-tone speech therapy group and the control group, at a 1:1 ratio. The control group will receive 20 sessions of conventional speech-language therapy, while the five-tone speech therapy group will receive 20 sessions of five-tone speech therapy in addition to conventional speech-language therapy. The primary outcome measure for this study will be the score on Western Aphasia Battery. Secondary outcomes include communicative abilities in daily living, percentage of correct information units and correct information units per minute, as well as resting-state electroencephalogram, event-related potentials and MRI data. All outcomes will be evaluated at 0 weeks (before intervention) and at 4 weeks (after 20 intervention sessions).

Ethics and dissemination
Ethical approval of this study was granted by the ethics committees of the Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine (2023KY-009-01) and the Third People’s Hospital Affiliated to Fujian University of Traditional Chinese Medicine (2023-kl-010). Recruitment commenced on 24 April 2023. Informed consent will be obtained from all participants of the trial (or from their legal guardians, where applicable). The outcomes of the trial will be disseminated through peer-reviewed publications.

Trial registration number
ChiCTR2300069257.

Leggi
Settembre 2024

Do tobacco regulatory and economic factors influence smoking cessation outcomes? A post-hoc analysis of the multinational EAGLES randomised controlled trial

Introduction
We previously reported global regional differences in smoking cessation outcomes, with smokers of US origin having lower quit rates than smokers from some other countries. This post-hoc analysis examined global regional differences in individual-level and country-level epidemiological, economic and tobacco regulatory factors that may affect cessation outcomes.

Methods
EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) was a randomised controlled trial that evaluated first-line cessation medications and placebo in 8144 smokers with and without psychiatric disorders from 16 countries across seven regions. Generalised linear and stepwise logistic regression models that considered pharmacotherapy treatment, psychiatric diagnoses, traditional individual-level predictors (eg, demographic and smoking characteristics) and country-specific smoking prevalence rates, gross domestic product (GDP) per capita, relative cigarette cost and WHO-derived MPOWER scores were used to predict 7-day point prevalence abstinence at the end of treatment.

Results
In addition to several traditional predictors, three of four country-level variables predicted short-term abstinence: GDP (0.54 (95% CI 0.47, 0.63)), cigarette relative income price (0.62 (95% CI 0.53, 0.72)) and MPOWER score (1.03 (95% CI 1.01, 1.06)). Quit rates varied across regions (22.0% in Australasia to 55.9% in Mexico). With northern North America (USA and Canada) as the referent, the likelihood of achieving short-term abstinence was significantly higher in Western Europe (OR 1.4 (95% CI 1.14, 1.61)), but significantly lower in Eastern Europe (0.39 (95% CI 0.22, 0.69)) and South America (0.17 (95% CI 0.08, 0.35)).

Conclusions
Increased tobacco regulation was associated with enhanced quitting among participants in the EAGLES trial. Paradoxically, lower GDP, and more affordable cigarette pricing relative to a country’s GDP, were also associated with higher odds of quitting. Geographical region was also a significant independent predictor.

Trial registration number
ClinicalTrials.gov, NCT01456936.

Leggi
Settembre 2024

Scientific evidence of acupuncture for post-stroke motor impairment: protocol for an overview of systematic reviews and meta-analyses

Introduction
Several systematic reviews and meta-analyses (SRs/MAs) of clinical trials showed the efficacy of acupuncture for post-stroke motor impairment. To systematically estimate and synthesise these results, we aimed to conduct an overview of SRs/MAs to summarise the evidence and evaluate the methodological quality regarding the effectiveness and safety of acupuncture for post-stroke motor impairment.

Methods and analysis
This is a protocol for an overview of SRs/MAs. A literature search will be conducted in PubMed, Embase, Web of Science and Cochrane Central Registry of Controlled Trials from the construction of the database to March 2024. SRs/MAs evaluating the efficacy of acupuncture in post-stroke motor impairment patients will be included. Two independent investigators will screen and evaluate related SRs/MAs back-to-back. We will extract data into a predefined form designed to summarise the key characteristics of each study. The evaluation of methodological quality of the included SRs/MAs will be assessed using AMSTAR-2, the PRISMA 2020 checklist and the GRADE grading system.

Ethics and dissemination
Ethics approval is not required for this overview as we will only analyse published literature. The results will be published in a peer-reviewed journal.

PROSPERO registration number
CRD42024502006.

Leggi
Settembre 2024

Effects of yoga compared with health promotion on health-related quality of life in adults with post-COVID-19 condition: protocol for a randomised controlled trial

Introduction
Post-COVID-19 condition (post COVID, also known as long COVID) is a global public health issue estimated to affect over 100 million people. Common symptoms include fatigue, dyspnoea and cognitive dysfunction (‘brain fog’). Over time, these symptoms have an adverse effect on mental health, physical activity and quality of life (QoL). The condition requires innovative and feasible treatment approaches that can be effective and self-managed. Physical activity is essential for good health; however, aerobic exercise or weightlifting may not be suitable for post COVID patients who experience fatigue or breathlessness. The benefits of yoga include improved flexibility, mobility, body strength and balance. It is also shown to reduce symptoms of fatigue and improve breathing efficiency, mental health and QoL. This study protocol describes the rationale and methods for a randomised controlled trial (RCT) of a yoga-based intervention designed for adults with post COVID.

Methods and analysis
A two-group, parallel, RCT with blinded follow-up assessments. Participants will be randomised with a 1:1 allocation to either a 12-week yoga-based intervention or a 12-week health promotion (active comparison) intervention. In total, 88 participants aged 30–65 years will be recruited and randomised. The primary outcome is health-related QoL (36-item Short-Form). Secondary outcomes are dyspnoea, fatigue, sleep quality, cognitive functions, mental fatigue, depression, anxiety, physical activity, demographic data and physical health measures. Data will be analysed as intention-to-treat basis, using linear mixed modelling. All assessments are conducted at Karolinska Institutet in Stockholm, Sweden. The yoga-based intervention will take place at a yoga studio centrally located in Stockholm city.

Ethics and dissemination
The study is approved by the Swedish Ethical Review Authority, reference number 2023/06518-01. All participants must sign written informed consent before enrolment and are free to withdraw from the study at any point. Key results will be available through research articles and seminars.

Trial registration number
German Clinical Trials Register, DRKS00032837.

Leggi
Settembre 2024

Regional wall motion abnormalities on focused transthoracic echocardiography in patients presenting with acute chest pain: a predefined post hoc analysis of the prospective single-centre observational EPIC-ACS study

Objectives
We evaluated the ability of the assessment of regional wall motion abnormalities (RWMA) detected via transthoracic echocardiography to predict the presence of obstructive coronary artery disease (CAD) in patients presenting with acute chest pain to the emergency department.

Design
Prospective single-centre observational study.

Setting
Tertiary care university hospital emergency unit.

Participants
Patients presenting to the emergency department with acute chest pain suggestive of obstructive CAD.

Primary outcome measure
The primary endpoint was defined as the presence of obstructive CAD, requiring revascularisation therapy.

Results
Overall, 657 patients (age 58.1±18.0 years, 53% men) were included in our study. RWMA were detected in 76 patients (11.6%). RWMA were significantly more frequent in patients reaching the primary endpoint (26.2% vs 7.6%, p

Leggi
Settembre 2024