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SurLym trial: study protocol for a multicentre pragmatic randomised controlled trial on the added value of reconstructive lymphatic surgery to decongestive lymphatic therapy for the treatment of lymphoedema

Por: Devoogdt · N. · De Vrieze · T. · Heroes · A.-K. · Bechter-Hugl · B. · Fieuws · S. · Godderis · L. · Segers · K. · Maleux · G. · Deltombe · T. · Frippiat · J. · Servaes · M. · Berners · A. · Fosseprez · P. · Krug · B. · Kayser · F. · Falticeanu · A. · Randon · C. · Monten · C. · Van Landuyt
Introduction

Lymphoedema is a chronic condition caused by lymphatic insufficiency. It leads to swelling of the limb/midline region and an increased risk of infection. Lymphoedema is often associated with mental and physical problems limiting quality of life. The first choice of treatment is a conservative treatment, consisting of exercises, skin care, lymph drainage and compression. Reconstructive lymphatic surgery is also often performed, that is, lymphovenous anastomoses, lymph node transfer or a combination. However, robust evidence on the effectiveness of reconstructive lymphatic surgery is missing. Therefore, the objective of this trial is to investigate the added value of reconstructive lymphatic surgery to the conservative treatment in patients with lymphoedema.

Methods and analysis

A multicentre randomised controlled and pragmatic trial was started in March 2022 in three Belgian university hospitals. 90 patients with arm lymphoedema and 90 patients with leg lymphoedema will be included. All patients are randomised between conservative treatment alone (control group) or conservative treatment with reconstructive lymphatic surgery (intervention group). Assessments are performed at baseline and at 1, 3, 6, 12, 18, 24 and 36 months. The primary outcome is lymphoedema-specific quality of life at 18 months. Key secondary outcomes are limb volume and duration of wearing the compression garment at 18 months. The approach of reconstructive lymphatic surgery is based on presurgical investigations including clinical examination, lymphofluoroscopy, lymphoscintigraphy, lymph MRI or CT angiography (if needed). All patients receive conservative treatment during 36 months, which is applied by the patient’s own physical therapist and by the patient self. From months 7 to 12, the hours a day of wearing the compression garment are gradually decreased.

Ethics and dissemination

The study has been approved by the ethical committees of University Hospitals Leuven, Ghent University Hospital and CHU UCL Namur. Results will be disseminated via peer-reviewed journals and presentations.

Trial registration number

NCT05064176

Helping patients prepare their dependent children for parental death: mixed-methods evaluation of a codeveloped training programme for palliative and allied healthcare professionals in the UK

Por: Cockle-Hearne · J. · Groothuizen · J. E. · Ream · E.
Objectives

To evaluate how the codesigned training programme, ‘No conversation too tough’, can help cancer, palliative and wider healthcare professionals support patients to communicate with their dependent children when a parent is dying. We examined perceptions of learning provided by the training, its contribution to confidence in communicating with families when a parent is dying, and subjective experience of, and reactions to, the training. We also explored potential changes in practice behaviours.

Design

Pre–post, convergent, parallel, mixed-methods study. Motivations for practice change were measured quantitatively, and qualitatively through semi-structured interviews. Non-parametric analysis was conducted for self-efficacy and outcome expectancy measures; descriptive statistics examined perceptions of usefulness; intentions to use learning in practice and reactions to the training. Semi-structured interviews examined motivations and perceptions of learning in depth. A 6-week, practice log recorded immediate practice effects and reflections.

Setting

1-day training delivered 3 times, total delegates 36: online December 2021, February 2022, face-to-face March 2022. Questionnaires delivered correspondingly in online or paper formats, semi-structured interviews online.

Participants

Pre–post: palliative care professionals (n=14/12), acute cancer clinical nurse specialists (n=16/11), other healthcare professionals (n=5/5).

Results

Positive changes were observed in self-efficacy (17 of 19 dimensions p

Conclusions

The training programme has the potential to effect change in practice behaviours. A large-scale study will evaluate the roll-out of the training delivered to individual professionals and whole teams across the UK. It will provide longer-term feedback to understand practice behaviour and mediators of change across professional roles.

Association between indoor air pollution and depression: a systematic review and meta-analysis of cohort studies

Por: Zhang · X. · Ding · L. · Yang · F. · Qiao · G. · Gao · X. · Xiong · Z. · Zhu · X.
Objectives

Incomplete combustion of solid fuel and exposure to secondhand smoke (SHS) are the primary causes of indoor air pollution (IAP), potentially leading to detrimental effects on individual mental health. However, current evidence regarding the association between IAP and depression remains inconclusive. This study aims to systematically investigate the evidence regarding the association between IAP and the risk of depression.

Design

Systematic review and meta-analysis of cohort studies.

Data sources

Two independent reviewers searched PubMed, the Cochrane Library, Web of Science and EMBASE for available studies published up to 13 January 2024.

Eligibility criteria

We included all cohort studies published in English that aimed to explore the relationship between IAP from solid fuel use and SHS exposure and the risk of depression.

Data extraction and synthesis

Two independent reviewers extracted data and assessed the risk of bias. The association between IAP and depression was calculated using pooled relative risk (RR) with 95% CIs. Heterogeneity was assessed using the I2 value, and the effect estimates were pooled using fixed-effects or random-effects models depending on the results of homogeneity analysis.

Results

We included 12 articles with data from 61 217 participants. The overall findings demonstrated a significant association between IAP exposure and depression (RR=1.22, 95% CI: 1.13 to 1.31), although with substantial heterogeneity (I2=75%). Subgroup analyses based on pollutant type revealed that IAP from solid fuel use was associated with a higher risk of depression (RR=1.20, 95% CI: 1.13 to 1.26; I2=62%; 5 studies, 36 768 participants) than that from SHS exposure (RR=1.11, 95% CI: 0.87 to 1.41; I2=80%; 7 studies, 24 449 participants). In terms of fuel use, the use of solid fuel for cooking (RR: 1.23, 95% CI: 1.16 to 1.31; I2=58%; 4 studies, 34 044 participants) and heating (RR 1.15, 95% CI: 1.04 to 1.27; I2=65%; 3 studies, 24 874 participants) was associated with increased depression risk.

Conclusions

The findings from this systematic review and meta-analysis of cohort studies indicated an association between exposure to IAP and depression.

PROSPERO registration number

CRD42022383285.

Facilitators, barriers and impacts to implementing dementia care training for staff in long-term care settings by using fully immersive virtual reality: a scoping review protocol

Por: Hung · L. · Zhao · Y. · Lam · M. · Ren · H. · Wong · K. L. Y.
Introduction

The rapid growth of the ageing population underscores the critical need for dementia care training among care providers. Innovative virtual reality (VR) technology has created opportunities to improve dementia care training. This scoping review will specifically focus on the barriers, facilitators and impacts of implementing fully immersive VR training for dementia care among staff in long-term care (LTC) settings.

Methods and analysis

We will follow the Joanna Briggs Institute’s scoping review methodology to ensure scientific rigour. We will collect literature of all languages with abstracts in English from CINAHL, Medline, Scopus, Embase, Web of Science and ProQuest database until 31 December 2023. Grey literature from Google Scholar and AgeWell websites will be included. Inclusion criteria encompass papers involving paid staff (Population), fully immersive VR training on dementia care (Concept) and LTC settings (Context). Literature referring only to non-paid caregivers, non-fully immersive VR or other chronic diseases will be excluded. Literature screening, data extraction and analysis will be conducted by two reviewers separately. We will present a narrative summary with a charting table on the main findings.

Ethics and dissemination

This work does not require ethics approval, given the public data availability for this scoping review. Through a comprehensive overview of the current evidence regarding impacts, barriers and facilitators on this topic, potential insights and practical recommendations will be generated to support the implementation of VR training to enhance staff competence in LTC settings. The findings will be presented in a journal article and shared with practitioners on the frontline.

Sex and gender-based analysis and diversity metric reporting in acute care trials published in high-impact journals: a systematic review

Por: Granton · D. · Rodrigues · M. · Raparelli · V. · Honarmand · K. · Agarwal · A. · Friedrich · J. O. · Perna · B. · Spaggiari · R. · Fortunato · V. · Risdonne · G. · Kho · M. · VanderKaay · S. · Chaudhuri · D. · Gomez-Builes · C. · D'Aragon · F. · Wiseman · D. · Lau · V. I. · Lin · C. · Reid
Objective

To characterise sex and gender-based analysis (SGBA) and diversity metric reporting, representation of female/women participants in acute care trials and temporal changes in reporting before and after publication of the 2016 Sex and Gender Equity in Research guideline.

Design

Systematic review.

Data sources

We searched MEDLINE for trials published in five leading medical journals in 2014, 2018 and 2020.

Study selection

Trials that enrolled acutely ill adults, compared two or more interventions and reported at least one clinical outcome.

Data abstraction and synthesis

4 reviewers screened citations and 22 reviewers abstracted data, in duplicate. We compared reporting differences between intensive care unit (ICU) and cardiology trials.

Results

We included 88 trials (75 (85.2%) ICU and 13 (14.8%) cardiology) (n=111 428; 38 140 (34.2%) females/women). Of 23 (26.1%) trials that reported an SGBA, most used a forest plot (22 (95.7%)), were prespecified (21 (91.3%)) and reported a sex-by-intervention interaction with a significance test (19 (82.6%)). Discordant sex and gender terminology were found between headings and subheadings within baseline characteristics tables (17/32 (53.1%)) and between baseline characteristics tables and SGBA (4/23 (17.4%)). Only 25 acute care trials (28.4%) reported race or ethnicity. Participants were predominantly white (78.8%) and male/men (65.8%). No trial reported gendered-social factors. SGBA reporting and female/women representation did not improve temporally. Compared with ICU trials, cardiology trials reported significantly more SGBA (15/75 (20%) vs 8/13 (61.5%) p=0.005).

Conclusions

Acute care trials in leading medical journals infrequently included SGBA, female/women and non-white trial participants, reported race or ethnicity and never reported gender-related factors. Substantial opportunity exists to improve SGBA and diversity metric reporting and recruitment of female/women participants in acute care trials.

PROSPERO registration number

CRD42022282565.

Person-centred care (PCC) research in Ghana: a scoping review protocol

Por: Amoh · G. K. A. · Addo · A. K. · Odiase · O. · Tahir · P. · Getahun · M. · Aborigo · R. A. · Essuman · A. · Yawson · A. E. · Essuman · V. A. · Afulani · P. A.
Introduction

Person-centred care (PCC) is provision of care that is respectful of and responsive to individual patient preferences, needs and values, and ensures that patient values guide all clinical decisions. While there is a large body of evidence on the benefits of PCC in high-income countries, little research exists on PCC in Ghana and Sub-Saharan Africa at large. Most studies on PCC have focused on maternity care as part of the global movement of respectful maternity care. The few studies on patient experiences and health system responsiveness beyond maternal health also highlight gaps in patient experience and satisfaction as well as discrimination in health facilities, which leads to the most vulnerable having the poorest experiences. The protocol for this scoping review aims to systematically map the extent of literature focused on PCC in Ghana by identifying patient expectations and preferences, barriers and facilitators, and interventions.

Methods and analysis

The protocol will be guided by the Arksey and O’Malley methodological framework and recommendations by Levac et al. A comprehensive search strategy will be used to search for published articles in PubMed, EMBASE, Web of Science and the African Journals Online from their inception to August 2022. Grey literature and reference lists of included studies will also be searched. Two independent reviewers will perform the literature search, eligibility assessments and study selection. Any disagreements will be resolved through discussion with a third reviewer. A Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram for the scoping reviews will be used to outline the study selection process. Extracted data from the included articles will be synthesised and reported under key concepts derived from the outcomes of the scoping review.

Ethics and dissemination

This scoping review does not require ethical approval. The findings will be disseminated through publications and conference presentations.

Scoping review registration

OSF Registration DOI 10.17605/OSF.IO/ZMDH9.

Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial)

Por: 't Hart · J. W. H. · Noordman · B. J. · Palsgraaf-Huisbrink · J. · Dunkelgrun · M. · Zengerink · H. F. · Birnie · E. · van Det · M. J. · Boerma · E.-J. G. · de Castro · S. M. M. · Hazebroek · E. J. · Langenhoff · B. S. · Verhoef · C. · Apers · J. A.
Introduction

By implementation of Enhanced Recovery After Bariatric Surgery protocols and day-care surgery, early discharge poses a challenge if excessive bleeding occurs after bariatric surgery. Tranexamic acid (TXA) has demonstrated efficacy in other surgical fields and in bariatric pilot studies. This trial aims to assess the efficacy of peroperative administration of TXA in reducing haemorrhage in patients undergoing gastric bypass surgery.

Method and analysis

This is a multicentre, phase III, double-blind randomised controlled trial in six high-volume bariatric centres in the Netherlands. A total of 1524 eligible patients, aged 18 years or older, undergoing primary gastric bypass surgery (either Roux-en-Y gastric bypass or one-anastomosis gastric bypass) will be randomised between TXA and placebo (1:1, variable block, stratified for centre, day-care/overnight stay and type of surgery) after obtaining informed consent (2.5% less haemorrhage, power 80%, 2-sided-α 0.05 and 10% dropout). Exclusion criteria are pregnancy, amedical history of acute bleeding (without cause), venous thrombotic events (VTEs), epilepsy, anticoagulant use and iatrogenic bleeding during surgery (aside from staple line). The primary outcome is postoperative haemorrhage requiring intervention within 30 days postoperatively. Secondary outcome measures are staple line reinforcement, blood loss, duration of surgery, postoperative haemoglobin, vital parameters, minor and major complications, side effects of TXA (nausea, hypotension and VTE), length of hospital stay and directly made costs.

Ethics and dissemination

Written informed consent will be obtained from all participants. The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 7 February 2023 (registration number: R22.102). Results will be disseminated through peer-reviewed publications and conferences.

Trial registration number

NCT05464394

EvolvRehab-MoveWell telerehabilitation for stroke survivors: study protocol for a feasibility with embedded initial proof-of-concept study

Por: Perks · J. · McBride · P. · Mansoubi · M. · Clatworthy · P. · Hulme · C. · Taylor · G. · Warner · M. · Dawes · H.
Introduction

Stroke is a leading cause of disability throughout the world. Unilateral upper limb impairment is common in people who have had a stroke. As a result of impaired upper limb function, people who have had a stroke often employ abnormal ‘compensatory’ movements. In the short term, these compensatory movements allow the individual to complete tasks, though long-term movement in this manner can lead to limitations. Telerehabilitation offers the provision of rehabilitation services to patients at a remote location using information and communication technologies. ‘EvolvRehab’ is one such telerehabilitation system, which uses activities to assess and correct compensatory upper body movements, although the feasibility of its use is yet to be determined in National Health Service services. Using EvolvRehab, we aim to assess the feasibility of 6 weeks telerehabilitation in people after a stroke.

Methods and analysis

A multisite feasibility study with embedded design phase. Normally distributed data will be analysed using paired samples t-tests; non-normally distributed data will be analysed using related samples Wilcoxon signed rank tests. Thematic content analysis of interview transcripts will be used to investigate the usability and perceived usefulness of the EvolvRehab kit.

Ethics and dissemination

This study has received ethical approval from Solihull Research Ethics Committee (REC reference: 23/WM/0054). Dissemination will be carried out according to the dissemination plan co-written with stroke survivors, including academic publications and presentations; written reports; articles in publications of stakeholder organisations; presentations to and publications for potential customers.

Trial registration number

NCT05875792.

Do patients with nephrotic syndrome have an increased risk of osteoporosis? A nationwide population-based retrospective cohort study in Taiwan

Por: Liao · C.-Y. · Chung · C.-H. · Wei · K.-Y. · Tseng · M.-F. · Lin · F.-H. · Tsao · C.-H. · Chien · W.-C. · Chu · P. · Wu · C.-C.
Objectives

To evaluate whether nephrotic syndrome (NS) and further corticosteroid (CS) use increase the risk of osteoporosis in Asian population during the period January 2000–December 2010.

Design

Nationwide population-based retrospective cohort study.

Setting

All healthcare facilities in Taiwan.

Participants

A total of 28 772 individuals were enrolled.

Interventions

26 614 individuals with newly diagnosed NS between 2000 and 2010 were identified and included in out study. 26 614 individuals with no NS diagnosis prior to the index date were age matched as controls. Diagnosis of osteoporosis prior to the diagnosis of NS or the same index date was identified, age, sex and NS-associated comorbidities were adjusted.

Primary outcome measure

To identify risk differences in developing osteoporosis among patients with a medical history of NS.

Results

After adjusting for covariates, osteoporosis risk was found to be 3.279 times greater in the NS cohort than in the non-NS cohort, when measured over 11 years after NS diagnosis. Stratification revealed that age older than 18 years, congestive heart failure, hyperlipidaemia, chronic kidney disease, liver cirrhosis and NS-related disease including diabetes mellitus, hepatitis B infection, hepatitis C infection, lymphoma and hypothyroidism, increased the risk of osteoporosis in the NS cohort, compared with the non-NS cohort. Additionally, osteoporosis risk was significantly higher in NS patients with CS use (adjusted HR (aHR)=3.397). The risk of osteoporosis in NS patients was positively associated with risk of hip and vertebral fracture (aHR=2.130 and 2.268, respectively). A significant association exists between NS and subsequent risk for osteoporosis.

Conclusion

NS patients, particularly those treated with CS, should be evaluated for subsequent risk of osteoporosis.

Combining antibiotic‐loaded bone cement‐based free vastus lateralis muscle‐sparing flap with split‐thickness skin grafts: A reliable strategy for reconstructing diabetic foot ulcers at non‐weight‐bearing areas

Abstract

Diabetic foot ulcers (DFUs) present significant challenges due to their associated amputation rates, mortality, treatment complexity and excessive costs. Our earlier work introduced a wound surgical integrated treatment (WSIT) for DFUs, yielding promising outcomes. This study focuses on a specific WSIT protocol employing antibiotic-loaded bone cement (ALBC) in the first Stage, and free vastus lateralis muscle-sparing (VLMS) flaps and split-thickness skin grafts (STSGs) in the second stage to repair non-weight-bearing DFUs. From July 2021 to July 2023, seven DFU patients (aged 47–71 years) underwent this treatment. Demographic data, hospital stay and repair surgery times were collected. Histological and immunohistochemical analyses assessed angiogenesis, collagen deposition and inflammation. SF-36 questionnaire measured pre- and postoperative quality of life. Preoperative ultrasound Doppler showed that the peak blood flow velocity of the recipient area artery was significantly >30 cm/s (38.6 ± 6.8 cm/s) in all patients. Muscle flap sizes varied from 8 × 3.5 × 1 to 18 × 6 × 2 cm. The operation time of the repair surgery was 156.9 ± 15.08 minutes, and the hospital stay was 18.9 ± 3.3 days. Histological analysis proved that covering DFUs with ALBC induced membrane formation and increased collagen, neovascularization and M2 macrophages fraction while reducing M1 macrophages one. All grafts survived without amputation during a 7- to 24-month follow-up, during which SF-36 scores significantly improved. A combination of ALBC with free VLMS flaps and STSGs proved to be safe and effective for reconstructing non-weight-bearing DFUs. It rapidly controlled infection, enhanced life quality and foot function, and reduced hospitalization time. We advocate integrating this strategy into DFU treatment plans.

Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME) study: protocol for a randomised controlled trial

Por: Little · R. B. · Carter · S. J. · Motl · R. W. · Hunter · G. · Cook · A. · Liu · N. · Krontiras · H. · Lefkowitz · E. J. · Turan · B. · Schleicher · E. · Rogers · L. Q.
Introduction

Breast cancer survivors have an increased risk for chronic fatigue and altered gut microbiota composition, both with negative health and quality of life affects. Exercise modestly improves fatigue and is linked to gut microbial diversity and production of beneficial metabolites. Studies suggest that gut microbiota composition is a potential mechanism underlying fatigue response to exercise. Randomised controlled trials testing the effects of exercise on the gut microbiome are limited and there is a scarcity of findings specific to breast cancer survivors. The objective of this study is to determine if fitness-related modifications to gut microbiota occur and, if so, mediate the effects of aerobic exercise on fatigue response.

Methods and analysis

The research is a randomised controlled trial among breast cancer survivors aged 18–74 with fatigue. The primary aim is to determine the effects of aerobic exercise training compared with an attention control on gut microbiota composition. The secondary study aims are to test if exercise training (1) affects the gut microbiota composition directly and/or indirectly through inflammation (serum cytokines), autonomic nervous system (heart rate variability) or hypothalamic-pituitary-adrenal axis mediators (hair cortisol assays), and (2) effects on fatigue are direct and/or indirect through changes in the gut microbiota composition. All participants receive a standardised controlled diet. Assessments occur at baseline, 5 weeks, 10 weeks and 15 weeks (5 weeks post intervention completion). Faecal samples collect the gut microbiome and 16S gene sequencing will identify the microbiome. Fatigue is measured by a 13-item multidimensional fatigue scale.

Ethics and dissemination

The University of Alabama at Birmingham Institutional Review Board (IRB) approved this study on 15 May 2019, UAB IRB#30000320. A Data and Safety Monitoring Board convenes annually or more often if indicated. Findings will be disseminated in peer-reviewed journals and conference presentations.

Trial registration number

ClinicalTrials.gov, NCT04088708.

Factors influencing optimal diabetes care and clinical outcomes in Thai patients with type 2 diabetes mellitus: a multilevel modelling analysis

Por: Surawit · A. · Pongkunakorn · T. · Manosan · T. · Mongkolsucharitkul · P. · Chamnan · P. · Suvarnabhumi · K. · Puangpet · T. · Suta · S. · Pumeiam · S. · Pinsawas · B. · Ophakas · S. · Pisitpornsuk · S. · Utchin · C. · Mayurasakorn · K.
Background

Increasing levels of poor glycaemic control among Thai patients with type 2 diabetes mellitus (T2DM) motivated us to compare T2DM care between urban and suburban primary care units (PCUs), to identify gaps in care, and to identify significant factors that may influence strategies to enhance the quality of care and clinical outcomes in this population.

Methods

We conducted a cross-sectional study involving 2160 patients with T2DM treated at four Thai PCUs from 2019 to 2021, comprising one urban and three suburban facilities. Using mixed effects logistic regression, we compared care factors between urban and suburban PCUs.

Results

Patients attending suburban PCUs were significantly more likely to undergo eye (adjusted OR (AOR): 1.83, 95% CI 1.35 to 1.72), foot (AOR: 1.61, 95% CI 0.65 to 4.59) and HbA1c (AOR: 1.66, 95% CI 1.09 to 2.30) exams and achieved all ABC (HbA1c, blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C)) goals (AOR: 2.23, 95% CI 1.30 to 3.83). Conversely, those at an urban PCU were more likely to undergo albuminuria exams. Variables significantly associated with good glycaemic control included age (AOR: 1.51, 95% CI 1.31 to 1.79), T2DM duration (AOR: 0.59, 95% CI 0.41 to 0.88), FAACE (foot, HbA1c, albuminuria, LDL-C and eye) goals (AOR: 1.23, 95% CI 1.12 to 1.36) and All8Q (AOR: 1.20, 95% CI 1.05 to 1.41). Chronic kidney disease (CKD) was significantly linked with high triglyceride and HbA1c levels (AOR: 5.23, 95% CI 1.21 to 7.61). Elevated HbA1c levels, longer T2DM duration, insulin use, high systolic BP and high lipid profile levels correlated strongly with diabetic retinopathy (DR) and CKD progression.

Conclusion

This highlights the necessity for targeted interventions to bridge urban–suburban care gaps, optimise drug prescriptions and implement comprehensive care strategies for improved glycaemic control, DR prevention and CKD progression mitigation among in Thai patients with T2DM. The value of the clinical target aggregate (ABC) and the process of care aggregate (FAACE) was also conclusively demonstrated.

Exploring type 2 diabetes self-management practices in rural Bangladesh: facilitators, barriers and expectations--a qualitative study protocol

Por: Chowdhury · H. A. · Joham · A. E. · Kabir · A. · Rahman · A. K. M. F. · Ali · L. · Harrison · C. L. · Billah · B.
Background

Type 2 diabetes mellitus (T2DM) is a global public health crisis impacting low-income and middle-income countries such as Bangladesh. While self-management is encouraged for individuals with T2DM, there is a significant lack of knowledge regarding the factors of facilitators, barriers and expectations associated with T2DM self-management in Bangladesh. This research aims to investigate the potential elements that support, impede and are anticipated in the effective practice of self-management for T2DM in rural areas of Bangladesh.

Methods and analysis

This study will use an exploratory qualitative approach. 16 focus group discussions, 13 in-depth interviews and 9 key informant interviews will be conducted among multilevel stakeholders, including people with T2DM, their caregivers, healthcare providers, health managers/administrators and policy planners. Interviews will be audio-recorded, transcribed, translated and analysed using thematic analysis.

Ethics and dissemination

This research project has been approved by the Monash University Human Research Ethics Committee (project reference number: 39483) and the Ethical Review Committee of the Centre for Injury Prevention and Research, Bangladesh (Memo: CIPRB/ERC/2023/14). Research findings will be disseminated in peer-reviewed journals and conference presentations. Published reports will include group data. Individual data privacy will be strictly maintained.

Optimal approach for ultrasound-guided transversus abdominis plane (TAP) blocks for abdominal surgeries: a protocol for systematic review and meta-analysis

Por: Zhu · Q. · Zhang · D. · Wei · Y.
Introduction

Transversus abdominis plane (TAP) blocks are commonly used for postoperative analgesia after various abdominal surgeries. There are several different approaches for performing TAP blocks, mainly including posterior, lateral and subcostal approaches. An increasing number of randomised controlled trials (RCTs) have compared the analgesic effects of different TAP block approaches, but the results have not been consistent. This protocol aims to determine the optimal approach of ultrasound-guided TAP blocks for postoperative analgesia after abdominal surgery.

Methods and analysis

Four databases, including Web of Science, PubMed, EMBASE and the Cochrane Library will be systematically searched to identify RCTs that compared the analgesic effects of different ultrasound-guided TAP block approaches. The search interval will range from the inception of the databases to 30 July 2024. The postoperative opioid consumption over 24 hours will be defined as the primary outcome. The secondary outcomes will include the analgesia duration, postoperative pain scores at rest and during movement at different timepoints and the incidence of adverse effects. All the statistical analyses will be conducted using RevMan V.5.4. The quality of evidence will be evaluated by the Grading of Recommendations Assessment, Development and Evaluation approach.

Ethics and dissemination

Ethical approval will not be needed. The results will be submitted to one peer-reviewed journal when completed.

PROSPERO registration number

CRD42024510141.

Prevalence and associated factors of neurocognitive disorder among people living with HIV/AIDS in the South Gondar zone primary hospitals, North-West Ethiopia: an institution-based cross-sectional study

Por: Kelebie · M. A. · Tinsae · T. · Alemayehu · B. F. · Walelign · G. K. · Takelle · G. M.
Objective

To assess the prevalence and associated factors of neurocognitive disorder among people living with HIV/AIDS in South Gondar primary hospitals, North-West Ethiopia, 2023.

Design

Institution-based cross-sectional study design.

Setting

South Gondar primary hospitals, North-West Ethiopia.

Participants

608 participants were recruited using the systematic random sampling technique.

Measurement

Data were collected using an interviewer-administered questionnaire and medical chart reviews. The International HIV Dementia Scale was used to screen for neurocognitive disorder. The data were entered through EPI-DATA V.4.6 and exported to SPSS V.21 statistical software for analysis. In the bivariable logistic regression analyses, variables with a value of p

Results

The prevalence of neurocognitive disorder among HIV-positive participants was 39.1%. In multivariable logistic regression, lower level of education (adjusted OR (AOR)=2.94; 95% CI 1.29 to 6.82), unemployment (AOR=2.74; 95% CI 1.29 to 6.84) and comorbid medical illness (AOR=1.80; 95% CI 1.03 to 3.14) were significantly associated with neurocognitive disorder.

Conclusion

HIV-associated neurocognitive problems affected over a third of the participants. According to the current study, comorbid medical conditions, unemployment and low educational attainment are associated with an increased risk of neurocognitive disorder. Therefore, early detection and treatment are essential.

Saxon Epidemiological Study in General Practice-6 (SESAM-6): protocol of a cross-sectional study

Por: Gräfe · W. · Liebig · L. · Deutsch · T. · Schübel · J. · Bergmann · A. · Bleckwenn · M. · Frese · T. · Brütting · C. · Riemenschneider · H.
Introduction

General practitioners (GPs) are mostly the first point of contact for patients with health problems in Germany. There is only a limited epidemiological overview data that describe the GP consultation hours based on other than billing data. Therefore, the aim of Saxon Epidemiological Study in General Practice-6 (SESAM-6) is to examine the frequency of reasons for encounter, prevalence of long-term diagnosed diseases and diagnostic and therapeutic decisions in general practice. This knowledge is fundamental to identify the healthcare needs and to develop strategies to improve the GP care. The results of the study will be incorporated into the undergraduate, postgraduate and continuing medical education for GP.

Methods and analysis

This cross-sectional study SESAM-6 is conducted in general practices in the state of Saxony, Germany. The study design is based on previous SESAM studies. Participating physicians are assigned to 1 week per quarter (over a survey period of 12 months) in which every fifth doctor–patient contact is recorded for one-half of the day (morning or afternoon). To facilitate valid statements, a minimum of 50 GP is required to document a total of at least 2500 doctor–patient contacts. Univariable, multivariable and subgroup analyses as well as comparisons to the previous SESAM data sets will be conducted.

Ethics and dissemination

The study was approved by the Ethics Committee of the Technical University of Dresden in March 2023 (SR-EK-7502023). Participation in the study is voluntary and will not be remunerated. The study results will be published in peer-reviewed scientific journals, preferably with open access. They will also be disseminated at scientific and public symposia, congresses and conferences. A final report will be published to summarise the central results and provided to all study participants and the public.

Status of the midwifery workforce and childbirth services and the impact of midwife staffing on birth outcomes in China: a multicentre cross-sectional study

Por: Zhu · W. · Zhu · C. · Min · H. · Li · L. · Wang · X. · Wu · J. · Zhu · X. · Gu · C.
Objective

To investigate the status of the midwifery workforce and childbirth services in China and to identify the association between midwife staffing and childbirth outcomes.

Design

A descriptive, multicentre cross-sectional survey.

Setting

Maternity hospitals from the eastern, central and western regions of China.

Participants

Stratified sampling of maternity hospitals between 1 July and 31 December 2021.

The sample hospitals received a package of questionnaires, and the head midwives from the participating hospitals were invited to fill in the questionnaires.

Results

A total of 180 hospitals were selected and investigated, staffed with 4159 midwives, 412 obstetric nurses and 1007 obstetricians at the labour and delivery units. The average efficiency index of annual midwifery services was 272 deliveries per midwife. In the sample hospitals, 44.9% of women had a caesarean delivery and 21.4% had an episiotomy. Improved midwife staffing was associated with reduced rates of instrumental vaginal delivery (adjusted β –0.032, 95% CI –0.115 to –0.012, p

Conclusion

The rates of childbirth interventions including the overall caesarean section in China and the episiotomy rate, especially in the central region, remain relatively high. Improved midwife staffing was associated with reduced rates of instrumental vaginal delivery and episiotomy, indicating that further investments in the midwifery workforce could produce better childbirth outcomes.

Coordination of oral anticoagulant care at hospital discharge (COACHeD): pilot randomised controlled trial

Por: Holbrook · A. · Troyan · S. · Telford · V. · Koubaesh · Y. · Vidug · K. · Yoo · L. · Deng · J. · Lohit · S. · Giilck · S. · Ahmed · A. · Talman · M. · Leonard · B. · Refaei · M. · Tarride · J.-E. · Schulman · S. · Douketis · J. · Thabane · L. · Hyland · S. · Ho · J. M.-W. · Siegal · D.
Objectives

To evaluate whether a focused, expert medication management intervention is feasible and potentially effective in preventing anticoagulation-related adverse events for patients transitioning from hospital to home.

Design

Randomised, parallel design.

Setting

Medical wards at six hospital sites in southern Ontario, Canada.

Participants

Adults 18 years of age or older being discharged to home on an oral anticoagulant (OAC) to be taken for at least 4 weeks.

Interventions

Clinical pharmacologist-led intervention, including a detailed discharge medication management plan, a circle of care handover and early postdischarge virtual check-up visits to 1 month with 3-month follow-up. The control group received the usual care.

Outcomes measures

Primary outcomes were study feasibility outcomes (recruitment, retention and cost per patient). Secondary outcomes included adverse anticoagulant safety events composite, quality of transitional care, quality of life, anticoagulant knowledge, satisfaction with care, problems with medications and health resource utilisation.

Results

Extensive periods of restriction of recruitment plus difficulties accessing patients at the time of discharge negatively impacted feasibility, especially cost per patient recruited. Of 845 patients screened, 167 were eligible and 56 were randomised. The mean age (±SD) was 71.2±12.5 years, 42.9% females, with two lost to follow-up. Intervention patients were more likely to rate their ability to manage their OAC as improved (17/27 (63.0%) vs 7/22 (31.8%), OR 3.6 (95% CI 1.1 to 12.0)) and their continuity of care as improved (21/27 (77.8%) vs 2/22 (9.1%), OR 35.0 (95% CI 6.3 to 194.2)). Fewer intervention patients were taking one or more inappropriate medications (7 (22.5%) vs 15 (60%), OR 0.19 (95% CI 0.06 to 0.62)).

Conclusion

This pilot randomised controlled trial suggests that a transitional care intervention at hospital discharge for older adults taking OACs was well received and potentially effective for some surrogate outcomes, but overly costly to proceed to a definitive large trial.

Trial registration number

NCT02777047.

Determinants of unmet need for modern contraceptives in Ethiopia

Por: Gebrekidan · H. · Alemayehu · M. · Debelew · G. T.
Objective

To identify the determinants of the unmet need for modern contraceptives in Ethiopia.

Design

Community-based cross-sectional study.

Setting

Ethiopia.

Participants

A group of 6636 women of reproductive age (15–49 years) who were sexually active were included in the study.

Outcome

Unmet need for modern contraceptives

Method

The study used data from the 2019 Performance Monitoring for Action-Ethiopia survey, which was community-based and cross-sectional. The sample consisted of women aged 15–49 from households randomly selected to be nationally representative. Multinomial logistic regression and spatial analysis were performed to determine the factors influencing unmet needs for modern contraceptives. The descriptive analysis incorporated svy commands to account for clustering.

Results

The proportion of unmet need for modern contraceptives was 19.7% (95% CI: 18% to 21.5%). Women with supportive norms towards family planning had a lower risk of unmet need for spacing (relative risk ratio (RRR)=0.92, 95% CI: 0.86 to 0.99). Older age lowered the risk of unmet need for spacing 40–44 (RRR=0.28, 95% CI: 0.13 to 0.59) and 45–49 (RRR=0.11, 95% CI: 0.04 to 0.31). Being married increased the unmet need for spacing (RRR=1.9, 95% CI: 1.36 to 2.7) and limiting (RRR=3.7, 95% CI: 1.86 to 7.4). Increasing parity increases the risk of unmet need for spacing (RRR=1.27, 95% CI: 1.16 to 1.38) and limiting (RRR=1.26, 95% CI: 1.15 to 1.4). Contrarily, older age increased the risk of unmet need for limiting 40–44 (RRR=10.2, 95% CI: 1.29 to 79.5), 45–49 (RRR=8.4, 95% CI: 1.03 to 67.4). A clustered spatial unmet need for modern contraceptives was observed (Global Moran’s I=0.715: Z-Score=3.8496, p

Conclusions

High levels of unmet need for modern contraceptives were observed in Ethiopia, showing geographical variations. It is essential to address the key factors affecting women and work towards reducing disparities in modern contraceptive unmet needs among different regions.

Examining relationships between adverse childhood experiences and coping during the cost-of-living crisis using a national cross-sectional survey in Wales, UK

Por: Hughes · K. · Bellis · M. A. · Cresswell · K. · Hill · R. · Ford · K. · Hopkins · J. C.
Objectives

Adverse childhood experiences (ACEs) can affect individuals’ resilience to stressors and their vulnerability to mental, physical and social harms. This study explored associations between ACEs, financial coping during the cost-of-living crisis and perceived impacts on health and well-being.

Design

National cross-sectional face-to-face survey. Recruitment used a random quota sample of households stratified by health region and deprivation quintile.

Setting

Households in Wales, UK.

Participants

1880 Welsh residents aged ≥18 years.

Measures

Outcome variables were perceived inability to cope financially during the cost-of-living crisis; rising costs of living causing substantial distress and anxiety; and self-reported negative impact of rising costs of living on mental health, physical health, family relationships, local levels of antisocial behaviour and violence, and community support. Nine ACEs were measured retrospectively. Socioeconomic and demographic variables included low household income, economic inactivity, residential deprivation and activity limitation.

Results

The prevalence of all outcomes increased strongly with ACE count. Perceived inability to cope financially during the cost-of-living crisis increased from 14.0% with 0 ACEs to 51.5% with 4+ ACEs. Relationships with ACEs remained after controlling for socioeconomic and demographic factors. Those with 4+ ACEs (vs 0 ACEs) were over three times more likely to perceive they would be unable to cope financially and, correspondingly, almost three times more likely to report substantial distress and anxiety and over three times more likely to report negative impacts on mental health, physical health and family relationships.

Conclusions

Socioeconomically deprived populations are recognised to be disproportionately impacted by rising costs of living. Our study identifies a history of ACEs as an additional vulnerability that can affect all socioeconomic groups. Definitions of vulnerability during crises and communications with services on who is most likely to be impacted should consider childhood adversity and history of trauma.

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