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Barriers and facilitators for the adoption of peritoneal dialysis: protocol for a systematic review of qualitative studies

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Introduction

Peritoneal dialysis (PD) is an effective home-based treatment for end-stage kidney disease (ESKD) that offers several advantages over in-centre haemodialysis, including better quality of life, increased autonomy and lower costs. Despite these benefits, PD remains underused globally, with wide variations in adoption rates across countries. Qualitative studies have explored the experiences, perceptions and decision-making processes of patients, caregivers and healthcare providers regarding PD, but their findings have not been systematically synthesised. This protocol outlines a systematic review of qualitative studies to identify and synthesise the multilevel factors that influence PD adoption.

Methods and analysis

We will conduct a comprehensive search of electronic databases (PubMed, Web of Science, Embase, CINAHL, MEDLINE, The Cochrane Library, PsycINFO, Scopus) and grey literature sources for qualitative studies published in English from each database inception to June 2024 that explore barriers and facilitators to PD adoption. Two reviewers will independently screen titles, abstracts and full texts for eligibility based on predefined criteria. Eligible studies will include those that use qualitative methods (eg, interviews, focus groups, observations) to explore the perspectives of adult ESKD patients, their caregivers and/or healthcare providers on factors influencing PD adoption, initiation or maintenance. Data will be extracted using a standardised form and synthesised using thematic analysis. The methodological quality of included studies will be appraised using the Critical Appraisal Skills Programme Qualitative Checklist. Confidence in the review findings will be assessed using the Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research approach.

Ethics and dissemination

Ethics approval is not required as this study will merely synthesise data from published studies. The results will be disseminated through peer-reviewed publications as well as conference presentations.

Study registration

PROSPERO, CRD42024570521.

Introduction
Peritoneal dialysis (PD) is an effective home-based treatment for end-stage kidney disease (ESKD) that offers several advantages over in-centre haemodialysis, including better quality of life, increased autonomy and lower costs. Despite these benefits, PD remains underused globally, with wide variations in adoption rates across countries. Qualitative studies have explored the experiences, perceptions and decision-making processes of patients, caregivers and healthcare providers regarding PD, but their findings have not been systematically synthesised. This protocol outlines a systematic review of qualitative studies to identify and synthesise the multilevel factors that influence PD adoption.

Methods and analysis
We will conduct a comprehensive search of electronic databases (PubMed, Web of Science, Embase, CINAHL, MEDLINE, The Cochrane Library, PsycINFO, Scopus) and grey literature sources for qualitative studies published in English from each database inception to June 2024 that explore barriers and facilitators to PD adoption. Two reviewers will independently screen titles, abstracts and full texts for eligibility based on predefined criteria. Eligible studies will include those that use qualitative methods (eg, interviews, focus groups, observations) to explore the perspectives of adult ESKD patients, their caregivers and/or healthcare providers on factors influencing PD adoption, initiation or maintenance. Data will be extracted using a standardised form and synthesised using thematic analysis. The methodological quality of included studies will be appraised using the Critical Appraisal Skills Programme Qualitative Checklist. Confidence in the review findings will be assessed using the Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research approach.

Ethics and dissemination
Ethics approval is not required as this study will merely synthesise data from published studies. The results will be disseminated through peer-reviewed publications as well as conference presentations.

Study registration
PROSPERO, CRD42024570521.

Evaluation of an electronic clinical decision support algorithm to improve primary care management of acute febrile illness in rural Cambodia: protocol for a cluster-randomised trial

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Introduction

Acute febrile illness (AFI), traditionally attributed to malaria, is a common reason for seeking primary healthcare in rural South and Southeast Asia. However, malaria transmission has declined while health workers are often poorly equipped to manage non-malarial AFIs. This results in indiscriminate antibiotic prescribing and care escalation, which promotes antibiotic resistance and may increase healthcare costs. To address this problem, an electronic clinical decision support algorithm (eCDSA) called ‘Electronic clinical Decision support for Acute fever Management (EDAM)’ has been developed for primary health workers which integrates clinical, epidemiological and vital sign data with simple point-of-care tests to produce a diagnosis and management plan.

Methods and analysis

This is a pragmatic cluster-randomised trial aiming to assess the effect of EDAM and related training on antibiotic prescribing rates in rural Cambodian primary health centres (PHCs) as the primary outcome, along with a range of secondary outcomes including safety. Patients with AFI are eligible for recruitment if they are aged ≥1 year. A cluster is defined as a PHC and PHCs will be randomised to control (standard of care) and intervention (EDAM and associated training) arms, with 15 PHCs per arm. Patients will be followed up after 7 days to ascertain the safety profile of EDAM. Each PHC will recruit 152 patients (total 4560), based on a baseline antibiotic prescription rate of 25% and expected reduction to 17.5% with EDAM.

Ethics and dissemination

Results will be published in international peer-reviewed journals to inform the design of future versions of EDAM and of future trials of similar eCDSAs and other digital health interventions targeted towards rural populations. This study was approved by the Oxford University Tropical Research Ethics Committee (550-23) and the Cambodian National Ethics Committee for Health Research (395-NECHR).

Trial registration number

International Standard Randomized Controlled Trial Number Registry (ISRCTN15157105).

Introduction
Acute febrile illness (AFI), traditionally attributed to malaria, is a common reason for seeking primary healthcare in rural South and Southeast Asia. However, malaria transmission has declined while health workers are often poorly equipped to manage non-malarial AFIs. This results in indiscriminate antibiotic prescribing and care escalation, which promotes antibiotic resistance and may increase healthcare costs. To address this problem, an electronic clinical decision support algorithm (eCDSA) called ‘Electronic clinical Decision support for Acute fever Management (EDAM)’ has been developed for primary health workers which integrates clinical, epidemiological and vital sign data with simple point-of-care tests to produce a diagnosis and management plan.

Methods and analysis
This is a pragmatic cluster-randomised trial aiming to assess the effect of EDAM and related training on antibiotic prescribing rates in rural Cambodian primary health centres (PHCs) as the primary outcome, along with a range of secondary outcomes including safety. Patients with AFI are eligible for recruitment if they are aged ≥1 year. A cluster is defined as a PHC and PHCs will be randomised to control (standard of care) and intervention (EDAM and associated training) arms, with 15 PHCs per arm. Patients will be followed up after 7 days to ascertain the safety profile of EDAM. Each PHC will recruit 152 patients (total 4560), based on a baseline antibiotic prescription rate of 25% and expected reduction to 17.5% with EDAM.

Ethics and dissemination
Results will be published in international peer-reviewed journals to inform the design of future versions of EDAM and of future trials of similar eCDSAs and other digital health interventions targeted towards rural populations. This study was approved by the Oxford University Tropical Research Ethics Committee (550-23) and the Cambodian National Ethics Committee for Health Research (395-NECHR).

Trial registration number
International Standard Randomized Controlled Trial Number Registry (ISRCTN15157105).

RCN publishes new independent sector employment standards

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The post RCN publishes new independent sector employment standards appeared first on Nursing Times.

The Royal College of Nursing has published new employment standards for the independent health and social care sectors.
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Impact of dual sensory impairment on the risk of incident dementia: a protocol for a systematic review and meta-analysis

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Introduction

Strong evidence supports the importance of potentially modifiable risk factors for dementia, with sensory loss, particularly visual and hearing impairment, being prominent among them. While single sensory impairment has been widely investigated, the influence of concomitant visual and hearing impairment is still not clear. Thus, in this systematic review, we aim to evaluate the risk of developing all-cause dementia due to dual sensory (visual and hearing) impairment and to comprehensively explore possible sources of heterogeneity.

Methods and analysis

This protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 statement and has been registered on the PROSPERO international prospective register of systematic reviews. Our literature search will include two databases: MEDLINE-PubMed and Embase. The search strategy will consist of terms tailored for each database. We will include peer-reviewed longitudinal cohort studies reporting HRs. Screening and selection of articles will be performed independently by at least two reviewers using the Covidence systematic review manager. Discrepancies will be resolved by consensus. Data will be collected on study design, location, study setting, follow-up years, baseline demographics, sensory impairment and dementia diagnosis ascertainment, and number of adjusted covariates. The quality of the included studies will be evaluated using the Newcastle-Ottawa Scale for cohort studies. If meta-analysis is possible, we will perform DerSimonian-Laird random-effects models of HRs using the most adjusted model from each study. Subgroup analyses and meta-regressions are planned as a function of study setting, geographical location, sensory impairment and dementia diagnosis ascertainment, follow-up years and number of adjusted covariates.

Ethics and dissemination

Ethical approval is not required because this study involves data already published by other authors. Our findings will be disseminated by a peer-reviewed publication and presentations at relevant scientific conferences. The results will support the understanding of dementia’s modifiable risk factors and may motivate the development of screening interventions to prevent dementia.

PROSPERO registration number

CRD42023493401.

Introduction
Strong evidence supports the importance of potentially modifiable risk factors for dementia, with sensory loss, particularly visual and hearing impairment, being prominent among them. While single sensory impairment has been widely investigated, the influence of concomitant visual and hearing impairment is still not clear. Thus, in this systematic review, we aim to evaluate the risk of developing all-cause dementia due to dual sensory (visual and hearing) impairment and to comprehensively explore possible sources of heterogeneity.

Methods and analysis
This protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 statement and has been registered on the PROSPERO international prospective register of systematic reviews. Our literature search will include two databases: MEDLINE-PubMed and Embase. The search strategy will consist of terms tailored for each database. We will include peer-reviewed longitudinal cohort studies reporting HRs. Screening and selection of articles will be performed independently by at least two reviewers using the Covidence systematic review manager. Discrepancies will be resolved by consensus. Data will be collected on study design, location, study setting, follow-up years, baseline demographics, sensory impairment and dementia diagnosis ascertainment, and number of adjusted covariates. The quality of the included studies will be evaluated using the Newcastle-Ottawa Scale for cohort studies. If meta-analysis is possible, we will perform DerSimonian-Laird random-effects models of HRs using the most adjusted model from each study. Subgroup analyses and meta-regressions are planned as a function of study setting, geographical location, sensory impairment and dementia diagnosis ascertainment, follow-up years and number of adjusted covariates.

Ethics and dissemination
Ethical approval is not required because this study involves data already published by other authors. Our findings will be disseminated by a peer-reviewed publication and presentations at relevant scientific conferences. The results will support the understanding of dementia’s modifiable risk factors and may motivate the development of screening interventions to prevent dementia.

PROSPERO registration number
CRD42023493401.

Associations between body height and cardiovascular risk factors in women and men: a population-based longitudinal study based on The Tromso Study 1979-2016

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Objectives

Investigate associations between body height and cardiovascular disease risk factors at several time points in women and men across educational levels in Norway.

Design

Population-based longitudinal study.

Setting

The Tromsø Study, a population-based study with six surveys conducted between 1979 and 2016 in the municipality of Tromsø, Norway.

Primary and Secondary Outcome Measures

Body height, systolic blood pressure, diastolic blood pressure, serum total cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides and self-reported educational level.

Participants

23 512 women and men (49.6% women), aged 30–49 years at first participation in The Tromsø Study. Participants who attended more than one survey contributed with repeated measurements for blood pressure and lipids.

Blood pressure and lipid values were used as dependent variables in sex specific age-adjusted linear mixed models. Body height at first participation was the independent variable, while survey time point and educational level were used as covariates.

Results

Overall effect models showed inverse associations between body height and systolic blood pressure (reg. coefficients: –0.88 (95% CI –1.1, –0.6)), diastolic blood pressure (–0.41 (95% CI –0.6, –0.3)), serum total cholesterol (–0.12 (95% CI –0.1, –0.1)) and triglycerides (–0.06 (95% CI –0.1, –0.0)) in women. Inverse associations between body height and lipid variables were also observed in men (serum total cholesterol: –0.12 (95% CI –0.1, –0.1) triglycerides –0.05 (95% CI –0.1, –0.0)). Regression coefficients for associations between body height and cardiovascular risk factors varied across surveys. Overall, there were no associations between body height and cardiovascular risk factors based on educational level and survey.

Conclusion

The overall effect models support previous findings of inverse associations between body height and cardiovascular risk factors in women, and inverse associations between body height and lipids in men. Our study showed varied degrees of associations between body height and cardiovascular risk factors at different time points in Norway.

Objectives
Investigate associations between body height and cardiovascular disease risk factors at several time points in women and men across educational levels in Norway.

Design
Population-based longitudinal study.

Setting
The Tromsø Study, a population-based study with six surveys conducted between 1979 and 2016 in the municipality of Tromsø, Norway.

Primary and Secondary Outcome Measures
Body height, systolic blood pressure, diastolic blood pressure, serum total cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides and self-reported educational level.

Participants
23 512 women and men (49.6% women), aged 30–49 years at first participation in The Tromsø Study. Participants who attended more than one survey contributed with repeated measurements for blood pressure and lipids.
Blood pressure and lipid values were used as dependent variables in sex specific age-adjusted linear mixed models. Body height at first participation was the independent variable, while survey time point and educational level were used as covariates.

Results
Overall effect models showed inverse associations between body height and systolic blood pressure (reg. coefficients: –0.88 (95% CI –1.1, –0.6)), diastolic blood pressure (–0.41 (95% CI –0.6, –0.3)), serum total cholesterol (–0.12 (95% CI –0.1, –0.1)) and triglycerides (–0.06 (95% CI –0.1, –0.0)) in women. Inverse associations between body height and lipid variables were also observed in men (serum total cholesterol: –0.12 (95% CI –0.1, –0.1) triglycerides –0.05 (95% CI –0.1, –0.0)). Regression coefficients for associations between body height and cardiovascular risk factors varied across surveys. Overall, there were no associations between body height and cardiovascular risk factors based on educational level and survey.

Conclusion
The overall effect models support previous findings of inverse associations between body height and cardiovascular risk factors in women, and inverse associations between body height and lipids in men. Our study showed varied degrees of associations between body height and cardiovascular risk factors at different time points in Norway.

Real-world safety profile of zanubrutinib: a disproportionality analysis based on the FAERS database

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Objective

Zanubrutinib is a second-generation Bruton’s tyrosine kinase inhibitor that has been approved for the treatment of several B cell malignancies. The aim of this study was to evaluate adverse events (AEs) associated with zanubrutinib based on the real-world data.

Design

A disproportionality analysis was performed to identify the potential zanubrutinib-related AEs.

Setting

The Food and Drug Administration AE Reporting System database from the fourth quarter of 2019 to the third quarter of 2023.

Main outcome measures

The results of the disproportionality analyses were presented as reported ORs (RORs). When the lower limit of the 95% CI for the ROR is greater than 1 and the number of AE reports is≥3, it indicates that the preferred term (PT) may be a positive AE signal.

Results

A total of 846 AE reports with zanubrutinib as the primary suspect drug were obtained, with 2826 AEs. A total of 74 positive PT signals were detected across 18 system organ classes (SOCs). The most significant signal for SOC was ‘blood and lymphatic system disorders’ (ROR=2.8, 95% CI 2.3 to 3.3), while the most significant signal for PT was ‘haemorrhage subcutaneous’ (ROR=190.8, 95% CI 128.0 to 284.5). 13 unexpected off-label AEs were also observed, such as abnormal hair texture, skin discolouration, hypernatraemia, pericardial effusion and hypersomnia. The median time to onset of AEs associated with zanubrutinib was 51 days (IQR 13–192 days) and was consistent with the early failure model. In comparison with zanubrutinib monotherapy, the combination of zanubrutinib and rituximab therapy was linked to a higher risk of specific AEs, including myelosuppression, pneumonia, leucopenia, thrombocytopenia, abdominal pain, anaemia, pancytopenia and respiratory failure. Furthermore, the combination of zanubrutinib and chemotherapy increased the risk of several severe AEs, such as cardiac arrest, elevated blood lactate dehydrogenase levels and pancytopenia.

Conclusions

The results of the analysis provided valuable insights into the safety profile of zanubrutinib-treated patients, which was helpful for clinical monitoring and identifying potential AEs related to zanubrutinib.

Objective
Zanubrutinib is a second-generation Bruton’s tyrosine kinase inhibitor that has been approved for the treatment of several B cell malignancies. The aim of this study was to evaluate adverse events (AEs) associated with zanubrutinib based on the real-world data.

Design
A disproportionality analysis was performed to identify the potential zanubrutinib-related AEs.

Setting
The Food and Drug Administration AE Reporting System database from the fourth quarter of 2019 to the third quarter of 2023.

Main outcome measures
The results of the disproportionality analyses were presented as reported ORs (RORs). When the lower limit of the 95% CI for the ROR is greater than 1 and the number of AE reports is≥3, it indicates that the preferred term (PT) may be a positive AE signal.

Results
A total of 846 AE reports with zanubrutinib as the primary suspect drug were obtained, with 2826 AEs. A total of 74 positive PT signals were detected across 18 system organ classes (SOCs). The most significant signal for SOC was ‘blood and lymphatic system disorders’ (ROR=2.8, 95% CI 2.3 to 3.3), while the most significant signal for PT was ‘haemorrhage subcutaneous’ (ROR=190.8, 95% CI 128.0 to 284.5). 13 unexpected off-label AEs were also observed, such as abnormal hair texture, skin discolouration, hypernatraemia, pericardial effusion and hypersomnia. The median time to onset of AEs associated with zanubrutinib was 51 days (IQR 13–192 days) and was consistent with the early failure model. In comparison with zanubrutinib monotherapy, the combination of zanubrutinib and rituximab therapy was linked to a higher risk of specific AEs, including myelosuppression, pneumonia, leucopenia, thrombocytopenia, abdominal pain, anaemia, pancytopenia and respiratory failure. Furthermore, the combination of zanubrutinib and chemotherapy increased the risk of several severe AEs, such as cardiac arrest, elevated blood lactate dehydrogenase levels and pancytopenia.

Conclusions
The results of the analysis provided valuable insights into the safety profile of zanubrutinib-treated patients, which was helpful for clinical monitoring and identifying potential AEs related to zanubrutinib.

Neonatal nurse who faked qualifications jailed for five years

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The post Neonatal nurse who faked qualifications jailed for five years appeared first on Nursing Times.

A woman who lied about her experience and qualifications to get a job as a senior nurse on a Welsh neonatal unit has been jailed for five years.
The post Neonatal nurse who faked qualifications jailed for five years appeared first on Nursing Times.

Real-world usage pattern, effectiveness and safety of oral tramadol/dexketoprofen trometamol fixed-dose combination in moderate-to-severe acute pain in Asia: a prospective, multicentre, observational study

Real-world usage pattern, effectiveness and safety of oral tramadol/dexketoprofen trometamol fixed-dose combination in moderate-to-severe acute pain in Asia: a prospective, multicentre, observational study

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Objectives

This study aims to determine the usage pattern, effectiveness and safety of oral tramadol 75 mg and dexketoprofen trometamol 25 mg fixed-dose combination (TRAM/DKP FDC) in the short-term treatment of moderate-to-severe acute pain in real-world clinical practice in Asia.

Design

Real-world, prospective, multicentre, observational, phase IV study.

Setting

13 tertiary-care hospital sites across the Philippines, Thailand, Malaysia and Singapore.

Participants

Adult patients aged 18–80 years prescribed TRAM/DKP FDC for the short-term (up to 5 days) treatment of moderate-to-severe acute pain.

Main outcome measures

Primary endpoints were the proportion of patients prescribed TRAM/DKP FDC with different types of postsurgical and non-surgical treatments, and the average dosing frequency and duration of TRAM/DKP FDC treatment. Secondary endpoints were the proportion of patients achieving ≥30% pain reduction at 8 hours post the first dose (pain severity was assessed using the 11-point Numeric Pain Rating Scale); patient satisfaction at the end of treatment (based on a 5-point Patient Global Evaluation Scale (PGE)) and safety including the incidence of adverse drug reactions (ADRs).

Results

Among 599 patients (median age 44 years, 61.3% female) enrolled in this study, 68.61% (n=411) were postsurgical and 31.39% (n=188) were non-surgical patients. TRAM/DKP FDC was prescribed in a diverse group of postsurgical patients (eg, orthopaedic, general and cancer surgery) as well as in non-surgical conditions (eg, lower back pain and musculoskeletal pain). In the majority of patients, TRAM/DKP FDC was prescribed every 8 hours (65.94%) and for 5 days (78.80%). There was a significant reduction in pain intensity throughout the study and 65% of patients achieved ≥30% pain reduction from baseline at 8 hours post the first dose of TRAM/DKP FDC on day 1. 95.69% of patients were satisfied with the treatment (rated good, very good and excellent on the PGE scale). Overall, 13.9% of patients reported ADRs; most were mild to moderate in severity. The most common ADRs were nausea, vomiting and dizziness.

Conclusion

This study showed that TRAM/DKP FDC was used in diverse types of postsurgical and non-surgical patients in the real-world setting in Asia. It effectively reduced pain and was well tolerated with a high level of patient satisfaction.

Objectives
This study aims to determine the usage pattern, effectiveness and safety of oral tramadol 75 mg and dexketoprofen trometamol 25 mg fixed-dose combination (TRAM/DKP FDC) in the short-term treatment of moderate-to-severe acute pain in real-world clinical practice in Asia.

Design
Real-world, prospective, multicentre, observational, phase IV study.

Setting
13 tertiary-care hospital sites across the Philippines, Thailand, Malaysia and Singapore.

Participants
Adult patients aged 18–80 years prescribed TRAM/DKP FDC for the short-term (up to 5 days) treatment of moderate-to-severe acute pain.

Main outcome measures
Primary endpoints were the proportion of patients prescribed TRAM/DKP FDC with different types of postsurgical and non-surgical treatments, and the average dosing frequency and duration of TRAM/DKP FDC treatment. Secondary endpoints were the proportion of patients achieving ≥30% pain reduction at 8 hours post the first dose (pain severity was assessed using the 11-point Numeric Pain Rating Scale); patient satisfaction at the end of treatment (based on a 5-point Patient Global Evaluation Scale (PGE)) and safety including the incidence of adverse drug reactions (ADRs).

Results
Among 599 patients (median age 44 years, 61.3% female) enrolled in this study, 68.61% (n=411) were postsurgical and 31.39% (n=188) were non-surgical patients. TRAM/DKP FDC was prescribed in a diverse group of postsurgical patients (eg, orthopaedic, general and cancer surgery) as well as in non-surgical conditions (eg, lower back pain and musculoskeletal pain). In the majority of patients, TRAM/DKP FDC was prescribed every 8 hours (65.94%) and for 5 days (78.80%). There was a significant reduction in pain intensity throughout the study and 65% of patients achieved ≥30% pain reduction from baseline at 8 hours post the first dose of TRAM/DKP FDC on day 1. 95.69% of patients were satisfied with the treatment (rated good, very good and excellent on the PGE scale). Overall, 13.9% of patients reported ADRs; most were mild to moderate in severity. The most common ADRs were nausea, vomiting and dizziness.

Conclusion
This study showed that TRAM/DKP FDC was used in diverse types of postsurgical and non-surgical patients in the real-world setting in Asia. It effectively reduced pain and was well tolerated with a high level of patient satisfaction.

The chronic wound characterisation study and biobank: a study protocol for a prospective observational cohort investigation of bacterial community composition, inflammatory responses and wound-healing trajectories in non-healing wounds

The chronic wound characterisation study and biobank: a study protocol for a prospective observational cohort investigation of bacterial community composition, inflammatory responses and wound-healing trajectories in non-healing wounds

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Introduction

Chronic wounds affect 1%–2% of the global population, with rising incidence due to ageing and lifestyle-related diseases. Bacterial biofilms, found in 80% of chronic wounds, and scattered single-cell bacteria may hinder healing. Microbes are believed to negatively impact healing by exacerbating inflammation and host immune response.

Methods and analysis

The primary objective of the chronic wound characterisation (CWC) study is to investigate chronic wounds through a prospective observational cohort study exploring bacterial community composition, inflammatory responses and the influence of bacteria on wound-healing trajectories. The CWC study will be investigated through two cohorts: the predictive and in-depth.

The predictive cohort includes patients with a chronic wound scheduled for mechanical debridement. The debrided material will be collected for dual RNA sequencing and 16s ribosomal RNA gene sequencing, as well as samples for microbial culturing and a photo to assess the wound. Clinical data is recorded, and healing and/or other clinical endpoints are established through medical records.

The in-depth cohort includes and follows patients undergoing split-thickness skin grafting. Extensive sampling (ESwabs, biopsies, tape strips, debrided material and a sample of the skin graft) will be performed on surgery and patients will be seen at two follow-up visits. Samples will be analysed through culturing and next-generation sequencing methods. A biobank will be established comprising longitudinal clinical samples and clinical data.

Ethics and dissemination

The study has been approved by the board of health ethics, Capital Region of Denmark, under protocol number H-20032214. The study findings will be disseminated through peer-reviewed publications and showcased at both national and international conferences and meetings within the domains of microbiology, wound healing and infection.

Introduction
Chronic wounds affect 1%–2% of the global population, with rising incidence due to ageing and lifestyle-related diseases. Bacterial biofilms, found in 80% of chronic wounds, and scattered single-cell bacteria may hinder healing. Microbes are believed to negatively impact healing by exacerbating inflammation and host immune response.

Methods and analysis
The primary objective of the chronic wound characterisation (CWC) study is to investigate chronic wounds through a prospective observational cohort study exploring bacterial community composition, inflammatory responses and the influence of bacteria on wound-healing trajectories. The CWC study will be investigated through two cohorts: the predictive and in-depth.
The predictive cohort includes patients with a chronic wound scheduled for mechanical debridement. The debrided material will be collected for dual RNA sequencing and 16s ribosomal RNA gene sequencing, as well as samples for microbial culturing and a photo to assess the wound. Clinical data is recorded, and healing and/or other clinical endpoints are established through medical records.
The in-depth cohort includes and follows patients undergoing split-thickness skin grafting. Extensive sampling (ESwabs, biopsies, tape strips, debrided material and a sample of the skin graft) will be performed on surgery and patients will be seen at two follow-up visits. Samples will be analysed through culturing and next-generation sequencing methods. A biobank will be established comprising longitudinal clinical samples and clinical data.

Ethics and dissemination
The study has been approved by the board of health ethics, Capital Region of Denmark, under protocol number H-20032214. The study findings will be disseminated through peer-reviewed publications and showcased at both national and international conferences and meetings within the domains of microbiology, wound healing and infection.

Effectiveness of lower limb robotic rehabilitation on peak of oxygen uptake among patients with stroke: a systematic review and meta-analysis

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Objectives

To evaluate the effectiveness of lower limb robotic rehabilitation (LLRR) on cardiovascular health among individuals with stroke undergoing rehabilitation.

Design

Systematic reviews and meta-analysis.

Data sources

PubMed, Web of Science, Science Direct, Embase, China National Knowledge Infrastructure, Wangfang and VIP databases were searched from inception to 9 October 2023.

Eligibility criteria

Randomised controlled trials (RCTs) involving LLRR among individuals with stroke were included. We considered the potential impact of LLRR on the resting heart rate (HRrest), peak of oxygen uptake (VO2peak), peak of systolic blood pressure (SBPpeak) and peak of diastolic blood pressure (DBPpeak). Only studies published in Chinese or English were included.

Data extraction and synthesis

Two reviewers independently extracted data and assessed the risk of bias. Results were reported as Hedges’ g with 95% CIs. Meta-analyses were performed using a random effects model in STATA v17.0. The study was reported in compliance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.

Results

Five RCTs with 179 patients were included in the meta-analysis. According to the Guideline Development Tool results, half of the evidence grades were moderate. The results of the meta-analysis showed that there were significant differences among robotic rehabilitation group than the control group in VO2peak (standard mean difference (SMD): 0.71, 95% CI: (0.28, 1.13), p<0.001, I2=45.61%), but insignificant difference found in HRrest (SMD: 0.30, 95% CI: (–0.12, 0.73), p=0.16, I2=34.25%), SBPpeak (SMD: 0.04, 95% CI: (–0.44, 0.52), p=0.86, I2=28.75%) and DBPpeak (SMD: 0.46, 95% CI: (–3.82, 4.73), p=0.83, I2=0.00%). No significant heterogeneity was found among articles. The risk of bias assessment revealed that two studies showed low bias in most domains.

Conclusion

Individuals undergoing stroke rehabilitation may benefit from LLRR with improved VO2peak but insignificantly impacted HRrest, SBPpeak and DBPpeak.

PROSPERO registration number

CRD42022382259.

Objectives
To evaluate the effectiveness of lower limb robotic rehabilitation (LLRR) on cardiovascular health among individuals with stroke undergoing rehabilitation.

Design
Systematic reviews and meta-analysis.

Data sources
PubMed, Web of Science, Science Direct, Embase, China National Knowledge Infrastructure, Wangfang and VIP databases were searched from inception to 9 October 2023.

Eligibility criteria
Randomised controlled trials (RCTs) involving LLRR among individuals with stroke were included. We considered the potential impact of LLRR on the resting heart rate (HRrest), peak of oxygen uptake (VO2peak), peak of systolic blood pressure (SBPpeak) and peak of diastolic blood pressure (DBPpeak). Only studies published in Chinese or English were included.

Data extraction and synthesis
Two reviewers independently extracted data and assessed the risk of bias. Results were reported as Hedges’ g with 95% CIs. Meta-analyses were performed using a random effects model in STATA v17.0. The study was reported in compliance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.

Results
Five RCTs with 179 patients were included in the meta-analysis. According to the Guideline Development Tool results, half of the evidence grades were moderate. The results of the meta-analysis showed that there were significant differences among robotic rehabilitation group than the control group in VO2peak (standard mean difference (SMD): 0.71, 95% CI: (0.28, 1.13), p<0.001, I2=45.61%), but insignificant difference found in HRrest (SMD: 0.30, 95% CI: (–0.12, 0.73), p=0.16, I2=34.25%), SBPpeak (SMD: 0.04, 95% CI: (–0.44, 0.52), p=0.86, I2=28.75%) and DBPpeak (SMD: 0.46, 95% CI: (–3.82, 4.73), p=0.83, I2=0.00%). No significant heterogeneity was found among articles. The risk of bias assessment revealed that two studies showed low bias in most domains.

Conclusion
Individuals undergoing stroke rehabilitation may benefit from LLRR with improved VO2peak but insignificantly impacted HRrest, SBPpeak and DBPpeak.

PROSPERO registration number
CRD42022382259.

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