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Study protocol for two randomised controlled trials evaluating the effects of Cerclage in the reduction of extreme preterm birth and perinatal mortality in twin pregnancies with a short cervix or dilatation: the TWIN Cerclage studies

Por: van Gils · L. · de Boer · M. A. · Bosmans · J. · Duijnhoven · R. · Schoenmakers · S. · Derks · J. B. · Prins · J. R. · Al-Nasiry · S. · Lutke Holzik · M. · Lopriore · E. · van Drongelen · J. · Knol · M. H. · van Laar · J. O. E. H. · Jacquemyn · Y. · van Holsbeke · C. · Dehaene · I. · L
Introduction

Twin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and mortality. Currently there is a lack of effective treatments for women with a twin pregnancy and a short cervix or cervical dilatation. A possible effective surgical method to reduce extreme PTB in twin pregnancies with an asymptomatic short cervix or dilatation at midpregnancy is the placement of a vaginal cerclage.

Methods and analysis

We designed two multicentre randomised trials involving eight hospitals in the Netherlands (sites in other countries may be added at a later date). Women older than 16 years with a twin pregnancy at

Ethics and dissemination

This study has been approved by the Research Ethics Committees in the Netherlands on 3/30/2023. Participants will be required to sign an informed consent form. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results.

Trial registration number

ClinicalTrials.gov, NCT05968794.

Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial

Por: Ben · A. J. · van der Vaart · L. R. · E. Bosmans · J. · Roovers · J.-P. W. R. · Lagro-Janssen · A. L. M. · van der Vaart · C. H. · Vollebregt · A. · PEOPLE group · Milani · Bon · Bongers · Bos · Broekman · Dietz · van Eijndhoven · Hakvoort · Janszen · Kluivers · Link · Massop-Hel
Objective

To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective.

Design

Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up.

Setting

21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022.

Participants

1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital.

Interventions

Pessary therapy and surgery.

Primary and secondary outcome measures

The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of –10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires.

Results

For the PGI-I, the mean difference between pessary therapy and surgery was –0.05 (95% CI –0.14; 0.03) and –0.03 (95% CI –0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=–1807, 95% CI –2172; –1446 and mean difference=–1850, 95% CI –2349; –1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between 0 and 20 000/QALY gained from both perspectives.

Conclusions

Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care.

Trial registration number

NTR4883.

Combination of diuretics for acute heart failure: a protocol for a systematic review of randomised clinical trials with network meta-analysis and trial sequential analysis

Por: Nahiz · N. · Lukoschewitz · J. D. · Seven · E. · Olsen El Caidi · N. · Hove · J. D. · Jakobsen · J. · Grand · J.
Introduction

Acute heart failure (AHF) is a critical, costly condition with high mortality rates, affecting millions annually. Despite advances in cardiovascular care, AHF treatment lacks robust evidence. AHF commonly manifests with sudden heart failure symptoms such as pulmonary congestion, and the pathophysiology involves fluid overload. Initial treatment is based on intravenous diuretics typically, but the optimal combination of drugs remains uncertain.

Methods and analysis

We will systematically review randomised controlled trials enrolling patients with AHF and volume overload undergoing in-hospital diuretic treatment. We aim to investigate any diuretic intervention. Our search strategy includes the following databases: Embase, Medline, Latin American and Caribbean Health Sciences Literature, Web of Science and the Cochrane Central Register of Controlled Trials. The primary outcome is all-cause mortality. Secondary outcomes are serious adverse events, hospital readmission and kidney failure. Study results reported at the most extended follow-up will be used for all outcomes. If appropriate, we will conduct meta-analysis, trial sequential analysis and network meta-analysis.

Ethics and dissemination

No ethics approval is required for this study. The results will be published in a peer-reviewed journal in this field.

PROSPERO registration number

CRD42023463979.

How effective is simple mechanical wound debridement in reducing bacterial colonisation? Results of a prospective clinical study

Abstract

Background and aims: Bacteria in wounds can lead to stagnation of wound healing as well as to local or even systemic wound infections up to potentially lethal sepsis. Consequently, the bacterial load should be reduced as part of wound treatment. Therefore, the efficacy of simple mechanical wound debridement should be investigated in terms of reducing bacterial colonisation. Patients and methods: Patients with acute or chronic wounds were assessed for bacterial colonisation with a fluorescence camera before and after mechanical wound debridement with sterile cotton pads. If bacterial colonisation persisted, a second, targeted wound debridement was performed. Results: A total of 151 patients, 68 (45.0%) men and 83 (55.0%) women were included in this study. The male mean age was 71.0 years and the female 65.1 years. By establishing a new analysis method for the image files, we could document that the bacterial colonised areas were distributed 21.9% on the wound surfaces, 60.5% on the wound edges (up to 0.5 cm) and 17.6% on the wound surroundings (up to 1.5 cm). One mechanical debridement achieved a significant reduction of bacterial colonised areas by an average of 29.6% in the wounds, 18.9% in the wound edges and 11.8% in the wound surroundings and was increased by performing it a second time. Conclusions: It has been shown that even a simple mechanical debridement with cotton pads can significantly reduce bacterial colonisation without relevant side effects. In particular, the wound edges were the areas that were often most contaminated with bacteria and should be included in the debridement with special attention. Since bacteria remain in wounds after mechanical debridement, it cannot replace antimicrobial therapy strategies, but offer a complementary strategy to improve wound care. Thus, it could be shown that simple mechanical debridement is effective in reducing bacterial load and should be integrated into a therapeutic approach to wounds whenever appropriate.

The effect of hyaluronic acid and iodine complex gel compared to Vaseline on deep second‐degree burn wound in rats

Abstract

The combination of hyaluronic acid and iodine (Hyodine) has sparked interest in wound care and could have valuable applications in treating burn injuries. We aimed to provide valuable insight into the potential advantages, limitations, and implications of using Hyodine in burn wound management. We studied 25 male rats to assess the clinical outcomes and wound-healing effects of Hyodine. Each rat received a deep second-degree burn wound on their back using metal stamps. Subsequently, the rats were then randomly split into two groups. The first group was treated with a layer of Hyodine gel, while the second group received Vaseline. The burn sites were photographed on days 1, 7, 14, and 21 using a digital camera. After excision of the burn wounds, histopathology slides were stained and evaluated in terms of the degree of epithelialization, angiogenesis, inflammatory cells' infiltration, and collagen amount and arrangement. Despite a non-significant difference regarding the extent of burn wound area between intervention and control groups in the first day of experiment, the rats that were treated with Vaseline showed a significant decrease compared to those who received Hyodine in the second and third weeks (p = 0.02). On the other hand, epithelialization, pathology score, and collagen synthesis were significantly different between days 7, 14, and 21 of each group. However, collagen arrangement and neovascularization were only significantly different between days 7, 14, and 21 in Hyodine group (p = 0.02 and p = 0.03, respectively). The Hyodine gel may offer beneficial outcomes in patients with a burn wound. Based on our findings, despite a non-significant difference in the extent of burn wound area, using Hyodine revealed a significant improvement in different histopathological variables including neovascularization, and collagen arrangement.

Role of public health professionals in the climate and ecological crisis: a qualitative study

Por: van Hove · M. · Davey · P. · Gopfert · A.
Background

The climate and ecological emergency is the single biggest health threat facing humanity, yet it is not clear to what extent the public health workforce have been involved in work on this topic. This research aimed to establish what public health consultants working in local authorities in England perceive their role to be, whether the climate crisis is seen as a core component of public health and to identify barriers to action.

Methods

Semi-structured interviews were undertaken with a purposive sample (n=11) of local authority public health consultants in England. Participants were recruited via public health organisations, social media or snowballing. Thematic content analysis was used to identify codes and themes.

Results

Public health professionals have started work on climate change but reported being unclear about their role and feeling isolated working on this topic. Barriers to action included shortage of financial resources, communication tools and capacity, limited sharing of best practice, lack of local expertise and conflict between the need for action on climate change and other urgent issues.

Conclusion

We highlight the need to urgently address existing barriers to enable this important part of the public health workforce to play their role in tackling the climate and ecological crisis.

Interventions to reduce interpersonal stigma towards patients with a mental dysregulation for ambulance and emergency department healthcare professionals: review protocol for an integrative review

Por: Van de Glind · G. · Galenkamp · N. · Bleijenberg · N. · Schoonhoven · L. · Scheepers · F. E. · Crilly · J. · van Veen · M. · Ham · W. H. W.
Introduction

Worldwide, there is an increase in the extent and severity of mental illness. Exacerbation of somatic complaints in this group of people can result in recurring ambulance and emergency department care. The care of patients with a mental dysregulation (ie, experiencing a mental health problem and disproportionate feelings like fear, anger, sadness or confusion, possibly with associated behaviours) can be complex and challenging in the emergency care context, possibly evoking a wide variety of feelings, ranging from worry or pity to annoyance and frustration in emergency care staff members. This in return may lead to stigma towards patients with a mental dysregulation seeking emergency care. Interventions have been developed impacting attitude and behaviour and minimising stigma held by healthcare professionals. However, these interventions are not explicitly aimed at the emergency care context nor do these represent perspectives of healthcare professionals working within this context. Therefore, the aim of the proposed review is to gain insight into interventions targeting healthcare professionals, which minimise stigma including beliefs, attitudes and behaviour towards patients with a mental dysregulation within the emergency care context.

Methods and analysis

The protocol for a systematic integrative review is presented, using the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols recommendations. A systematic search was performed on 13 July 2023. Study selection and data extraction will be performed by two independent reviewers. In each step, an expert with lived experience will comment on process and results. Software applications RefWorks-ProQuest, Rayyan and ATLAS.ti will be used to enhance the quality of the review and transparency of process and results.

Ethics and dissemination

No ethical approval or safety considerations are required for this review. The proposed review will be submitted to a relevant international journal. Results will be presented at relevant medical scientific conferences.

PROSPERO registration number

CRD42023390664 (https://www.crd.york.ac.uk/prospero/).

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