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Effect and outcome of equity, diversity and inclusion programs in healthcare institutions: a systematic review protocol

Por: Buh · A. · Kang · R. · Kiska · R. · Fung · S. G. · Solmi · M. · Scott · M. · Salman · M. · Lee · K. · Milone · B. · Wafy · G. · Syed · S. · Dhaliwal · S. · Gibb · M. · Akbari · A. · Brown · P. A. · Hundemer · G. L. · Sood · M. M.
Background

Equity, diversity and inclusion (EDI) in the healthcare field are crucial in meeting the healthcare needs of a progressively diverse society. In fact, a diverse healthcare workforce enables culturally sensitive care, promotes health equity and enhances the understanding of various needs and patients’ viewpoints, potentially resulting in more effective patient treatment and improved patient outcomes. Despite this, information on the effectiveness of policies or programmes promoting EDI in health institutions is scarce. The objective of this systematic review is to assess the effects and outcomes of EDI programmes in healthcare institutions.

Methods

We will conduct Preferred Reporting Items for Systematic Reviews and Meta-Analyses-compliant systematic review of studies on EDI programmes and describe their effects and outcomes in healthcare institutions. We will search PubMed, Scopus, Web of Science, CINAHL and PsycINFO databases. Selected studies will include randomised control trials (RCTs), non-RCTs and cross-sectional studies published either in English or French. Quality appraisal of studies and a narrative synthesis of extracted data will be conducted as well as a meta-analysis if possible. The quality of evidence in this review will be assessed by the Grades of Recommendation, Assessment, Development and Evaluation.

Anticipated results

We anticipate that this systematic review will reveal information on the effect of EDI programmes and their outcomes in healthcare institutions. We expect this information will provide insights that will lead to improvements in designing EDI policies and programmes in healthcare institutions.

Ethics and dissemination

No ethical clearance is required for this study as no primary data will be collected. The final manuscript will be submitted to a journal for publication. In addition to this, the results of the study will also be disseminated through conference presentations to inform the research and clinical practice.

Review registration

This protocol has been registered with the International Prospective Register of Systematic Reviews; registration number CRD42024502781.

Cavitron ultrasonic surgical aspirator (CUSA) compared with conventional pancreatic transection in distal pancreatectomy: study protocol for the randomised controlled CUSA-1 pilot trial

Por: Holze · M. · Loos · M. · Hüttner · F. · Tenckhoff · S. · Feisst · M. · Knebel · P. · Klotz · R. · Mehrabi · A. · Michalski · C. · Pianka · F.
Background

Postoperative pancreatic fistula (POPF) remains the most common and serious complication after distal pancreatectomy. Many attempts at lowering fistula rates have led to unrewarding insignificant results as still up to 30% of the patients suffer from clinically relevant POPF. Therefore, the development of new innovative methods and procedures is still a cornerstone of current surgical research.

The cavitron ultrasonic surgical aspirator (CUSA) device is a well-known ultrasound-based parenchyma transection method, often used in liver and neurosurgery which has not yet been thoroughly investigated in pancreatic surgery, but the first results seem very promising.

Methods

The CUSA-1 trial is a randomised controlled pilot trial with two parallel study groups. This single-centre trial is assessor and patient blinded. A total of 60 patients with an indication for open distal pancreatectomy will be intraoperatively randomised after informed consent. The patients will be randomly assigned to either the control group with conventional pancreas transection (scalpel or stapler) or the experimental group, with transection using the CUSA device. The primary safety endpoint of this trial will be postoperative complications ≥grade 3 according to the Clavien-Dindo classification. The primary endpoint to investigate the effect will be the rate of POPF within 30 days postoperatively according to the ISGPS definition. Further perioperative outcomes, including postpancreatectomy haemorrhage, length of hospital stay and mortality will be analysed as secondary endpoints.

Discussion

Based on the available literature, CUSA may have a beneficial effect on POPF occurrence after distal pancreatectomy. The rationale of the CUSA-1 pilot trial is to investigate the safety and feasibility of the CUSA device in elective open distal pancreatectomy compared with conventional dissection methods and gather the first data on the effect on POPF occurrence. This data will lay the groundwork for a future confirmatory multicentre randomised controlled trial.

Ethics and dissemination

The CUSA-1 trial protocol was approved by the ethics committee of the University of Heidelberg (No. S-098/2022). Results will be published in an international peer-reviewed journal and summaries will be provided in lay language to study participants and their relatives.

Trial registration number

DRKS00027474.

Evaluation of a manualised neurofeedback training in psychosomatic-psychotherapeutic outpatient treatment (Neuro-pp-out): study protocol for a clinical mixed-methods pilot study

Por: Schmidt · K. L. · Kowalski · A. · Schweda · A. · Dörrie · N. · Skoda · E. M. · Bäuerle · A. · Teufel · M.
Introduction

Electroencephalographic neurofeedback (NFB), as a non-invasive form of brainwave training, has been shown to be effective in the treatment of various mental health disorders. However, only few results regarding manualised and standardised NFB trainings exist. This makes comparison as well as replication of studies difficult. Therefore, we developed a standard manual for NFB training in patients with mental health disorders attending a psychosomatic outpatient clinic. The current study aims at investigating the conduction of a standardised manual for NFB training in patients with mental health disorders. If successful, the study provides new opportunities to investigate NFB in a more controlled and comparable manner in clinical practice.

Methods and analysis

30 patients diagnosed with a mental health disorder will be included. After the educational interview, patients will undergo baseline diagnostics (T0). The subsequent intervention consists of 10 sessions of NFB training aiming at increasing sensorimotor rhythm and alpha-frequency amplitudes and decreasing theta-frequency and high beta-frequency amplitudes to induce relaxation and decrease subjective stress. All patients will undergo a post-treatment diagnostic assessment (T1) and a follow-up assessment 8 weeks following the closing session (T2). Changes in amplitude bands (primary outcome) will be recorded with electroencephalography during pre-assessments, post-assessments and follow-up assessments and during NFB sessions. Physiological (respiratory rate, blood volume pulse, muscle tension) and psychometric parameters (distress, perceived stress, relaxation ability, depressive and anxiety symptoms, insomnia, self-efficacy and quality of life) will be assessed at T0, T1 and T2. Moreover, satisfaction, acceptance and usability will be assessed at T1 after NFB training. Further, qualitative interviews about the experiences with the intervention will be conducted with NFB practitioners 6 months after the study starts. Quantitative data will be analysed using repeated measures analysis of variance as well as mediation analyses on mixed linear models. Qualitative data will be analysed using Mayring’s content analysis.

Ethics and dissemination

The study was approved by the ethics committee of the Medical Faculty of the University of Duisburg-Essen (23–11140-BO) and patient enrolment began in April 2023. Before participation, written informed consent by each participant will be required. Results will be published in peer-reviewed journals and conference presentations.

Trial registration number

Prospectively registered on 28 March 2023 in the German clinical trials register, DRKS00031497.

Cost of SARS-CoV-2 self-test distribution programmes by different modalities: a micro-costing study in five countries (Brazil, Georgia, Malaysia, Ethiopia and the Philippines)

Por: Hansen · M. A. · Lekodeba · N. A. · Chevalier · J. M. · Ockhuisen · T. · del Rey-Puech · P. · Marban-Castro · E. · Martinez-Perez · G. Z. · Shilton · S. · Radzi Abu Hassan · M. · Getia · V. · Weinert-Mizuschima · C. · Tenorio Bezerra · M. I. · Chala · L. · Leong · R. · Peregino · R.
Objective

Diagnostic testing is an important tool to combat the COVID-19 pandemic, yet access to and uptake of testing vary widely 3 years into the pandemic. The WHO recommends the use of COVID-19 self-testing as an option to help expand testing access. We aimed to calculate the cost of providing COVID-19 self-testing across countries and distribution modalities.

Design

We estimated economic costs from the provider perspective to calculate the total cost and the cost per self-test kit distributed for three scenarios that differed by costing period (pilot, annual), the number of tests distributed (actual, planned, scaled assuming an epidemic peak) and self-test kit costs (pilot purchase price, 50% reduction).

Setting

We used data collected between August and December 2022 in Brazil, Georgia, Malaysia, Ethiopia and the Philippines from pilot implementation studies designed to provide COVID-19 self-tests in a variety of settings—namely, workplace and healthcare facilities.

Results

Across all five countries, 173 000 kits were distributed during pilot implementation with the cost/test distributed ranging from $2.44 to $12.78. The cost/self-test kit distributed was lowest in the scenario that assumed implementation over a longer period (year), with higher test demand (peak) and a test kit price reduction of 50% ($1.04–3.07). Across all countries and scenarios, test procurement occupied the greatest proportion of costs: 58–87% for countries with off-site self-testing (outside the workplace, for example, home) and 15–50% for countries with on-site self-testing (at the workplace). Staffing was the next key cost driver, particularly for distribution modalities that had on-site self-testing (29–35%) versus off-site self-testing (7–27%).

Conclusions

Our results indicate that it is likely to cost between $2.44 and $12.78 per test to distribute COVID-19 self-tests across common settings in five heterogeneous countries. Cost-effectiveness analyses using these results will allow policymakers to make informed decisions on optimally scaling up COVID-19 self-test distribution programmes across diverse settings and evolving needs.

COVID-19 vaccine acceptance in the general population and under-resourced communities from high-income countries: realist review

Por: Gonzalez-Jaramillo · N. · Abbühl · D. · Roa-Diaz · Z. M. · Kobler-Betancourt · C. · Frahsa · A.
Objective

To compare vaccination willingness before rollout and 1 year post-rollout uptake among the general population and under-resourced communities in high-income countries.

Design

A realist review.

Data sources

Embase, PubMed, Dimensions ai and Google Scholar.

Setting

High-income countries.

Definitions

We defined vaccination willingness as the proportion of participants willing or intending to receive vaccines prior to availability. We defined vaccine uptake as the real proportion of the population with complete vaccination as reported by each country until November 2021.

Results

We included data from 62 studies and 18 high-income countries. For studies conducted among general populations, the proportion of vaccination willingness was 67% (95% CI 62% to 72%). In real-world settings, the overall proportion of vaccine uptake among those countries was 73% (95% CI 69% to 76%). 17 studies reported pre-rollout willingness for under-resourced communities. The summary proportion of vaccination willingness from studies reporting results among people from under-resourced communities was 52% (95% CI 0.46% to 0.57%). Real-world evidence about vaccine uptake after rollout among under-resourced communities was limited.

Conclusion

Our review emphasises the importance of realist reviews for assessing vaccine acceptance. Limited real-world evidence about vaccine uptake among under-resourced communities in high-income countries is a call to context-specific actions and reporting.

Restrictive use of Restraints and Delirium Duration in the Intensive Care Unit (R2D2-ICU): protocol for a French multicentre parallel-group open-label randomised controlled trial

Por: Sonneville · R. · Couffignal · C. · Sigaud · F. · Godard · V. · Audibert · J. · Contou · D. · Celier · A. · Djibre · M. · Schmidt · J. · Jaquet · P. · Mekontso Dessap · A. · Bourel · C. · Bellot · R. · Roy · C. · Lamara · F. · Essardy · F. · Timsit · J.-F. · Cornic · R. · Bouadma · L. · On b
Introduction

Physical restraint (PR) is prescribed in patients receiving invasive mechanical ventilation in the intensive care unit (ICU) to avoid unplanned removal of medical devices. However, it is associated with an increased risk of delirium. We hypothesise that a restrictive use of PR, as compared with a systematic use, could reduce the duration of delirium in ICU patients receiving invasive mechanical ventilation.

Methods and analysis

The Restrictive use of Restraints and Delirium Duration in ICU (R2D2-ICU) study is a national multicentric, parallel-group, randomised (1:1) open-label, controlled, superiority trial, which will be conducted in 10 ICUs. A total of 422 adult patients requiring invasive mechanical ventilation for an expected duration of at least 48 hours and eligible for prescription of PR will be randomly allocated within 6 hours from intubation to either the restrictive PR use group or the systematic PR use group, until day 14, ICU discharge or death, whichever comes first. In both groups, PR will consist of the use of wrist straps. The primary endpoint will be delirium or coma-free days, defined as the number of days spent alive in the ICU without coma or delirium within the first 14 days after randomisation. Delirium will be assessed using the Confusion Assessment Method-ICU twice daily. Key secondary endpoints will encompass agitation episodes, opioid, propofol, benzodiazepine and antipsychotic drug exposure during the 14-day intervention period, along with a core outcome set of measures evaluated 90 days postrandomisation.

Ethics and dissemination

The R2D2-ICU study has been approved by the Comité de Protection des Personnes (CPP) ILE DE FRANCE III—PARIS (CPP19.09.06.37521) on June 10th, 2019). Participant recruitment started on 25 January 2021. Results will be published in international peer-reviewed medical journals and presented at conferences.

Trial registration number

NCT04273360.

Colchicine for the treatment of patients with COVID-19: an updated systematic review and meta-analysis of randomised controlled trials

Por: Cheema · H. A. · Jafar · U. · Shahid · A. · Masood · W. · Usman · M. · Hermis · A. H. · Naseem · M. A. · Sahra · S. · Sah · R. · Lee · K. Y.
Objectives

We conducted an updated systematic review and meta-analysis to investigate the effect of colchicine treatment on clinical outcomes in patients with COVID-19.

Design

Systematic review and meta-analysis.

Data sources

We searched PubMed, Embase, the Cochrane Library, medRxiv and ClinicalTrials.gov from inception to January 2023.

Eligibility criteria

All randomised controlled trials (RCTs) that investigated the efficacy of colchicine treatment in patients with COVID-19 as compared with placebo or standard of care were included. There were no language restrictions. Studies that used colchicine prophylactically were excluded.

Data extraction and synthesis

We extracted all information relating to the study characteristics, such as author names, location, study population, details of intervention and comparator groups, and our outcomes of interest. We conducted our meta-analysis by using RevMan V.5.4 with risk ratio (RR) and mean difference as the effect measures.

Results

We included 23 RCTs (28 249 participants) in this systematic review. Colchicine did not decrease the risk of mortality (RR 0.99; 95% CI 0.93 to 1.05; I2=0%; 20 RCTs, 25 824 participants), with the results being consistent among both hospitalised and non-hospitalised patients. There were no significant differences between the colchicine and control groups in other relevant clinical outcomes, including the incidence of mechanical ventilation (RR 0.75; 95% CI 0.48 to 1.18; p=0.22; I2=40%; 8 RCTs, 13 262 participants), intensive care unit admission (RR 0.77; 95% CI 0.49 to 1.22; p=0.27; I2=0%; 6 RCTs, 961 participants) and hospital admission (RR 0.74; 95% CI 0.48 to 1.16; p=0.19; I2=70%; 3 RCTs, 8572 participants).

Conclusions

The results of this meta-analysis do not support the use of colchicine as a treatment for reducing the risk of mortality or improving other relevant clinical outcomes in patients with COVID-19. However, RCTs investigating early treatment with colchicine (within 5 days of symptom onset or in patients with early-stage disease) are needed to fully elucidate the potential benefits of colchicine in this patient population.

PROSPERO registration number

CRD42022369850.

Linking genetic counseling communication skills to patient outcomes and experiences using a community-engagement and provider-engagement approach: research protocol for the GC-PRO mixed methods sequential explanatory study

Por: Fisher · E. R. · Cragun · D. · Dedrick · R. F. · Lumpkins · C. Y. · Ramirez · M. · Kaphingst · K. A. · Petersen · A. · MacFarlane · I. M. · Redlinger-Grosse · K. · Shire · A. · Culhane-Pera · K. A. · Zierhut · H. A.
Introduction

In over 50 years since the genetic counseling (GC) profession began, a systematic study of GC communication skills and patient-reported outcomes in actual sessions across multiple clinical specialties has never been conducted. To optimize GC quality and improve efficiency of care, the field must first be able to comprehensively measure GC skills and determine which skills are most critical to achieving positive patient experiences and outcomes. This study aims to characterise GC communication skills using a novel and pragmatic measure and link variations in communication skills to patient-reported outcomes, across clinical specialties and with patients from diverse backgrounds in the USA. Our community-engagement and provider-engagement approach is crucial to develop recommendations for quality, culturally informed GC care, which are greatly needed to improve GC practice.

Methods and analysis

A mixed methods, sequential explanatory design will be used to collect and analyze: audio-recorded GC sessions in cancer, cardiac, and prenatal/reproductive genetic indications; pre-visit and post-visit quantitative surveys capturing patient experiences and outcomes and post-visit qualitative interview data. A novel, practical checklist will measure GC communication skills. Coincidence analysis will identify patterns of GC skills that are consistent with high scores on patient-reported measures. Two-level, multilevel models will be used to evaluate how GC communication skills and other session/patient characteristics predict patient-reported outcomes. Four community advisory boards (CABs) and a genetic counselor advisory board will inform the study design and analysis.

Ethics and dissemination

This study has been approved by the single Institutional Review Board of the University of Minnesota. This research poses no greater than minimal risk to participants. Results from this study will be shared through national and international conferences and through community-based dissemination as guided by the study’s CABs. A lay summary will also be disseminated to all participants.

De-imFAR phase II project: a study protocol for a cluster randomised implementation trial to evaluate the effectiveness of de-implementation strategies to reduce low-value statin prescribing in the primary prevention of cardiovascular disease

Por: Sanchez · A. · Pijoan · J. I. · Sainz de Rozas · R. · Lekue · I. · San Vicente · R. · Quindimil · J. A. · Rotaeche · R. · Etxeberria · A. · Mozo · C. · Martinez-Cengotitabengoa · M. · Monge · M. · Gomez-Ramirez · C. · Samper · R. · Ogueta Lana · M. · Celorrio · S. · Merino-Inda · N.
Introduction

This study aims to reduce potentially inappropriate prescribing (PIP) of statins and foster healthy lifestyle promotion in cardiovascular disease (CVD) primary prevention in low-risk patients. To this end, we will compare the effectiveness and feasibility of several de-implementation strategies developed following the structured design process of the Behaviour Change Wheel targeting key determinants of the clinical decision-making process in CVD prevention.

Methods and analysis

A cluster randomised implementation trial, with an additional control group, will be launched, involving family physicians (FPs) from 13 Integrated Healthcare Organisations (IHOs) of Osakidetza-Basque Health Service with non-zero incidence rates of PIP of statins in 2021. All FPs will be exposed to a non-reflective decision assistance strategy based on reminders and decision support tools. Additionally, FPs from two of the IHOs will be randomly assigned to one of two increasingly intensive de-implementation strategies: adding a decision information strategy based on knowledge dissemination and a reflective decision structure strategy through audit/feedback. The target population comprises women aged 45–74 years and men aged 40–74 years with moderately elevated cholesterol levels but no diagnosed CVD and low cardiovascular risk (REGICOR

Ethics and dissemination

The study was approved by the Basque Country Clinical Research Ethics Committee and was registered in ClinicalTrials.gov (NCT04022850). Results will be disseminated in scientific peer-reviewed journals.

Trial registration number

NCT04022850.

Meta‐analysis comparing different ultrasound detection methods to accurately assess wound healing and scar formation after caesarean section

Abstract

The accurate assessment of wound healing post-caesarean section, especially in twin pregnancies, remains a pivotal concern in obstetrics, given its implications for maternal health and recovery. Traditional methods, including conventional abdominal ultrasonography (CU), have been challenged by the advent of transvaginal ultrasonography (TU), offering potentially enhanced sensitivity and specificity. This meta-analysis directly compares the efficacy of TU and CU in evaluating wound healing and scar formation, crucial for optimizing postoperative care. Results indicate that TU is associated with significantly better outcomes in wound healing, demonstrated by lower REEDA scores (SMD = −20.56, 95% CI: [−27.34.20, −13.77], p < 0.01), and in scar formation reduction, evidenced by lower Manchester Scar Scale scores (SMD = −25.18, 95% CI: [−29.98, −20.39], p < 0.01). These findings underscore the potential of integrating TU into routine post-caesarean evaluation protocols to enhance care quality and patient recovery.

An in‐depth analysis of wound incidence and injury status among professional athletes: A comprehensive review

Abstract

This review aims to synthesize current knowledge on the incidence, characteristics and management of wounds and injuries among professional ice hockey athletes, with the specific focus on the emerging population of Chinese female players. An extensive literature search was conducted across several databases to gather data on injury patterns and wounds, causes, severity and prevention strategies in ice hockey. Special attention was given to studies involving female athletes and unique challenges faced by players in developing regions like China. The review also examined the impact of training modalities, protective equipment and medical interventions on injury rates. The findings reveal a significant seasonal fluctuation in wound incidence, with marked reduction following the preseason period. This trend underscores the effectiveness of adjusted training programmes and essential role of medical teams in injury prevention and rehabilitation. Analysis did not show significant difference in wound rates between technical and physical training sessions, suggesting that injuries are pervasive risk across all training activities. Skating, collisions and inadequate warm-ups were identified as the leading causes of wounds, highlighting areas for targeted preventive measures. The distribution of wounds across various body regions pointed to knee, lower back and wrist as the most vulnerable sites, necessitating focused protection and training adjustments. Ice hockey, particularly among female athletes in China, presents complex injury landscape characterized by the wide range of wounds. The study emphasizes the necessity of comprehensive, multidisciplinary approach to injury prevention that includes training modifications, enhanced protective gear and strategic medical oversight. By addressing the specific causes and patterns of injuries identified, stakeholders can better protect athletes from the inherent risks of the sport, promote safer play and extend career longevity.

Missed nursing care and its associated factors in public hospitals of Bahir Dar City, Northwest Ethiopia: a cross-sectional study

Por: Abere · Y. · Biresaw · H. · Misganaw · M. · Netsere · B. · Adal · O.
Objectives

The aim of this study was to investigate the prevalence of missed nursing care and its associated factors among public hospitals in Bahir Dar City, Northwest Ethiopia.

Design

An institution-based cross-sectional study was conducted among 369 randomly selected nurses.

Setting

The study was conducted in primary and secondary-level public hospitals in Bahir Dar City.

Participants

Nurses who had worked in hospitals in Bahir Dar City were included.

Intervention

No intervention was needed in this study.

Primary and secondary outcome measures

A binary logistic regression model was used for statistical analysis. Statistical significance of the association between outcome variables and independent variables was declared at a p value of

Results

The prevalence of missed nursing care in this study was 46.3% (95% CI: 41.7% to 50.9%). The activities most frequently missed were physical examination (56.4%), patient discharge planning and teaching (50.9%), providing emotional support to the patient and family (50.8%), monitoring input and output (50.2%), assisting with patient ambulation (48.5%) and documentation (48%). Factors associated with missed nursing care include: male professionals (adjusted OR (AOR): 2.9, 95% CI: 1.8 to 4.8), those who had not received on-the-job training (AOR: 2.2, 95% CI: 1.4 to 3.6), those who worked full 24-hour shifts (AOR: 3.7, 95% CI: 2.0 to 6.5), those who were dissatisfied with the level of teamwork (AOR: 4.6, 95% CI: 2.8 to 7.6) and those who had an intention to leave the nursing profession (AOR: 1.8, 95% CI: 1.1 to 2.9). These factors were statistically associated with missed nursing care.

Conclusion

A significant proportion of nurses missed essential nursing care activities. Efforts should be made to enhance training, improve teamwork among nurses, provide stability and adjust work shifts to mitigate this issue.

Impact of supplementation with iron-folic acid (IFA) and vitamin D3 compared with IFA alone on haemoglobin levels in elderly people with mild-to-moderate anaemia: protocol for the double-blind, randomised, placebo-controlled Iron and vitamin D trial in El

Por: Ahamed · F. · Jaiswal · A. · Sahoo · S. · Ghosh · T. · Kaur · A. · Rehman · T. · Goswami · K.
Introduction

Anaemia in the elderly is often difficult to treat with iron supplementation alone as prevalence of anaemia of chronic disease (ACD) alone or mixed with iron-deficiency anaemia (IDA) is high in this age group. Hepcidin remains high in ACD, preventing utilisation of iron for heme synthesis. Vitamin D3 has shown hepcidin suppression activity in both in vitro and in vivo studies. As there is no study assessing the effect of iron–folic acid (IFA) with vitamin D3 on haemoglobin levels in the elderly in India, we want to conduct this study to estimate the impact of supplementation of a therapeutic package of IFA and vitamin D3 on haemoglobin levels in the elderly with mild-to-moderate anaemia in comparison with IFA only. The study will also assess the impact of the proposed intervention on ferritin, hepcidin, 25-hydroxyvitamin D, C reactive protein (CRP) and parathyroid hormone (PTH) levels.

Methods and analysis

This study is a community-based, double-blind, placebo-controlled, randomised trial. The study will be done in the Kalyani municipality area. Individuals aged ≥60 years with mild-to-moderate anaemia and normal vitamin D3 levels will be randomised into the intervention (IFA and vitamin D3 supplementation) group or the control group (IFA and olive oil as placebo). All medications will be self-administered. Follow-up will be done on a weekly basis for 12 weeks. The calculated sample size is 150 in each arm. Block randomisation will be done. The primary outcome is change in haemoglobin levels from baseline to 12 weeks. Secondary outcome is change in serum ferritin, 25-hydroxyvitamin D, hepcidin, CRP and PTH levels from baseline to 12 weeks.

Ethics and dissemination

Ethical approval from the Institutional Ethics Committee of All India Institute of Medical Sciences Kalyani has been obtained (IEC/AIIMS/Kalyani/Meeting/2022/03). Written informed consent will be obtained from each study participant. The trial results will be reported through publication in a reputable journal and disseminated through health talks within the communities.

Trial registration number

CTRI/2022/05/042775.

Protocol version

Version 1.0.

Real-world data evaluating Guys rapid diagnostic clinic as an alternate pathway for patients with FIT levels below 10

Por: Monroy-Iglesias · M. J. · Martin · S. · Cargaleiro · C. · Jones · G. · Steward · L. · Murtagh · C. · Bruno · F. · Millwaters · J. · Schizas · A. · Watson · H. · Haire · A. · Haire · K. · Moss · C. L. · Russell · B. · Srirajaskanthan · R. · Van Hemelrijck · M. · Dolly · S.
Objective

To analyse the effectiveness of rapid diagnostic clinics (RDCs) as an alternative pathway for patients with concerning symptoms and a faecal immunochemical test (FIT) result

Design

A retrospective and prospective cohort study.

Setting

GSTT RDC, one of England’s largest single-centre RDCs. Sociodemographic and clinical characteristics of FIT

Participants

Patients with an FIT result

Results

A total of 1299 patients with an FIT

Conclusion

This study demonstrates the effectiveness of RDCs as an alternate pathway for FIT

The impact of delayed diagnosis and treatment due to COVID-19 on Australian thyroid cancer patients: a qualitative interview study

Por: D'souza · B. · Glover · A. · Bavor · C. · Brown · B. · Dodd · R. H. · Lee · J. C. · Millar · J. · Miller · J. A. · Zalcberg · J. R. · Serpell · J. · Ioannou · L. J. · Nickel · B.
Objectives

The study aims to investigate the perceptions of patients with thyroid cancer on the potential impact of diagnosis and treatment delays during the COVID-19 pandemic.

Design

This study involved qualitative semi-structured telephone interviews. The interviews were transcribed verbatim, analysed using the thematic framework analysis method and reported using the Consolidated Criteria for Reporting Qualitative Research.

Setting

Participants in the study were treated and/or managed at hospital sites across New South Wales and Victoria, Australia.

Participants

17 patients with thyroid cancer were interviewed and included in the analysis (14 females and 3 males).

Results

The delays experienced by patients ranged from 12 months. The patients reported about delays to diagnostic tests, delays to surgery and radioactive iodine treatment, perceived disease progression and, for some, the financial burden of choosing to go through private treatment to minimise the delay. Most patients also reported not wanting to experience delays any longer than they did, due to unease and anxiety.

Conclusions

This study highlights an increased psychological burden in patients with thyroid cancer who experienced delayed diagnosis and/or treatment during COVID-19. The impacts experienced by patients during this time may be similar in the case of other unexpected delays and highlight the need for regular clinical review during delays to diagnosis or treatment.

Effects of a therapeutic lifestyle modification intervention on cardiometabolic health, sexual functioning and health-related quality of life in perimenopausal Chinese women: protocol for a randomised controlled trial

Por: Wang · Y. · Miao · X. · Viwattanakulvanid · P.
Introduction

Perimenopause is a critical transitional period in reproductive ageing. A set of physiological and psychological changes can affect perimenopausal women’s quality of life and further threaten their older adult health conditions. In China, less than one-third of midlife women with menopausal symptoms have actively sought professional healthcare. Regarding the public health significance of comprehensive menopause management, the current study aims to investigate the effects of a therapeutic lifestyle modification (TLM) intervention on cardiometabolic health, sexual functioning and health-related quality of life among perimenopausal Chinese women.

Method and analysis

A randomised controlled trial with two parallel arms will be conducted at the gynaecology outpatient department of Yunnan Provincial Hospital of Traditional Chinese Medicine in China. 94 eligible perimenopausal women aged between 40 and 55 years will be recruited for the study. The TLM intervention consists of four elements: menopause-related health education, dietary guidance, pelvic floor muscle training and Bafa Wubu Tai Chi exercise. Participants will be randomly assigned (1:1) to receive either the 12-week TLM intervention or routine care via stratified blocked randomisation. The primary outcome is quality of life; secondary outcomes of interest include sexual functioning and cardiometabolic health. The outcome measures will be assessed at baseline and post-intervention. To explore the effects of the intervention, linear mixed models will be applied to test the changes between the two groups over time in each outcome based on an intention-to-treat analysis.

Ethics and dissemination

The Research Ethics Review Committee of Chulalongkorn University (COA No 178/66) and the Medical Ethics Committee of Yunnan Provincial Hospital of Traditional Chinese Medicine (IRB-AF-027-2022/02-02) approved the study protocol. Written informed consent will be obtained from all participants. Results will be published in peer-reviewed journals and disseminated through conferences.

Trial registration number

ChiCTR2300070648.

The role of orthobiologics in chronic wound healing

Abstract

Chronic wounds, characterized by prolonged healing processes, pose a significant medical challenge with multifaceted aetiologies, including local and systemic factors. Here, it explores the complex pathogenesis of chronic wounds, emphasizing the disruption in the normal phases of wound healing, particularly the inflammatory phase, leading to an imbalance in extracellular matrix (ECM) dynamics and persistent inflammation. Senescent cell populations further contribute to impaired wound healing in chronic lesions. Traditional medical management focuses on addressing underlying causes, but many chronic wounds resist to conventional treatments, necessitating innovative approaches. Recent attention has turned to autologous orthobiologics, such as platelet-rich plasma (PRP), platelet-rich fibrin (PRF) and mesenchymal stem cells (MSCs), as potential regenerative interventions. These biologically derived materials, including bone marrow aspirate/concentrate (BMA/BMAC) and adipose tissue-derived stem cells (ADSCs), exhibit promising cytokine content and regenerative potential. MSCs, in particular, have emerged as key players in wound healing, influencing inflammation and promoting tissue regeneration. This paper reviews relevant scientific literature regarding basic science and brings real-world evidence regarding the use of orthobiologics in the treatment of chronic wounds, irrespective of aetiology. The discussion highlights the regenerative properties of PRP, PRF, BMA, BMAC and SVF, showcasing their potential to enhance wound healing. Despite advancements, further research is essential to elucidate the specific roles of each orthobiologic and determine optimal applications for different wound types. The conclusion underscores the evolving landscape in chronic wound management, with a call for more comprehensive studies to refine treatment strategies and maximize the benefits of regenerative medicine.

The triglyceride glucose index as a sensitive predictor for the risk of MACCEs in patients with diabetic foot ulcers: An ambispective longitudinal cohort study

Abstract

The triglyceride glucose (TyG) index has been confirmed a predictive value for type 2 diabetes mellitus (T2DM). However, no research has yet confirmed whether there is a linear correlation between the TyG index and MACCEs in DFUs. The present study aimed to delve into the association between the TyG index and the risk of MACCEs in patients with DFUs. A total of 960 inpatients with DFUs were recruited. All participants were followed up every 6 months for 11 years with a median of 83 months. According to the cut-off value of the TyG index acquired from receiver operating characteristic (ROC) analysis, the subjects were divided into two groups: low-level (<9.12, n = 480) and high-level (≥9.12, n = 480). The relationship between the TyG index and MACCEs was evaluated by the multivariable Cox regression model, restricted cubic spline (RCS) model, stratified analysis and the Kaplan–Meier survival analysis. Out of 960 participants, 271 experienced MACCEs (28.22%), of whom 79 (29.15%) died. ROC analysis got the optimal TyG index cut-off value of 9.12. Multivariable Cox regression analysis combined with the RCS model showed that the TyG index was positively associated with MACCEs in an S-shaped non-linear dose-dependent manner within the range of TyG index 7.5–9.5 (p < 0.001). The Kaplan–Meier survival analysis indicated the higher the TyG index, the greater the cumulative incidence of MACCEs (log-rank, p < 0.001). The study first confirmed an S-shaped non-linear dose-dependent positive relationship between the TyG index and the risk of MACCEs in DFUs. Consequently, lowering the TyG index level aids in improving the prognosis of patients with DFUs.

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Status quo and influencing factors of multiprofessional and multidisciplinary teamwork for early mobilization in mechanically ventilated patients in ICUs: A multi‐centre survey study

Abstract

Aim

To understand the status quo of multiprofessional and multidisciplinary collaboration for early mobilization of mechanically ventilated patients in Chinese ICUs and identify any factors that may influence this practice.

Design

A multi-centre cross-sectional survey.

Methods

From October to November 2022, the convenience sampling method was used to select ICU multiprofessional and multidisciplinary early mobility members (including physicians, nurses and physiotherapists) from 27 tertiary general hospitals in 14 provinces, cities and autonomous regions of China. They were asked to complete an author-developed questionnaire on the status of collaboration and the Assessment of Inter-professional Team Collaboration Scale. A multiple linear regression model was used to analyse the factors associated with the level of collaboration.

Results

Physicians, nurses and physiotherapists mostly suffered from the lack of normative protocols, unclear division of responsibilities and unclear multiprofessional and multidisciplinary teams when using a collaborative approach to early activities. Multiple linear regression analysis showed that the number of ICU patients managed, the existence of norms and processes, the attitude of colleagues around them, the establishment of a team, communication methods and activity leaders were significant influences on the level of collaboration among members of the multiprofessional and multidisciplinary early activities.

Conclusion

The collaboration of multiprofessional and multidisciplinary early activity members for mechanically ventilated patients in the ICU remains unclear, and the collaboration strategy needs to be constructed and improved, taking into account China's human resources and each region's economic development level.

Impact

This study investigates the collaboration status of multiprofessional and multidisciplinary activity members from the perspective of teamwork, analyses the reasons affecting the level of collaboration and helps to develop better teamwork strategies to facilitate the implementation of early activities.

Patient or Public Contribution

The participants in this study were multiprofessional and multidisciplinary medical staff who performed early activities for ICU patients.

Experience and caring needs of patients with psoriasis: A qualitative meta‐synthesis

Abstract

Background

As a chronic skin disease, psoriasis often affects the physical, psychological and social status of the patient, which in turn impacts on their experience of illness and needs. However, there is no review of qualitative research that integrates and analyses the experiences and needs of these three influences from a holistic perspective.

Methods

This review follows the ENTREQ guidelines. Six English databases (JBI, Cochrane Library, PubMed, PsyINFO, CINAHL and Embase) and three Chinese databases (CNKI, VIP and Wanfang) were searched from January 2012 to October 2022. Literature was included if it was relevant to the experience of illness and caring needs of patients with psoriasis. The JBI-QARI was used to rate the quality of included studies.

Results

Eleven studies were included in the meta-synthesis. Four analytical themes were identified for analysis: physical challenges, psychological discomfort, social phenomena and caring needs.

Conclusions

The combined physical, psychological and social effects of psoriasis and the consequent caring needs should be emphasised. Health professionals, including doctors and nurses, should be aware of the multiple changes in patients and their coping strategies, provide information about psoriasis, monitor and follow-up regularly over time and obtain feedback to inform further treatment and care so as to develop high-quality therapeutic interventions to help and guide patients with their coping strategies.

Relevance to Clinical Practice

These findings describe the physical, psychological and social experiences of illness and caring needs of patients with psoriasis. Healthcare professionals should be more aware of patients' easily overlooked psychological and social distress, providing prompt attention and recognition of patients' experiences and needs, offering relevant assistance and support and enhancing daily, regular follow-up to help them improve their understanding of and ability to manage their illness.

No Patient or Public Contribution

This is a meta-synthesis without direct patient involvement.

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