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Carboprost versus Oxytocin as the first-line treatment of primary postpartum haemorrhage (COPE): protocol for a phase IV, double-blind, double-dummy, randomised controlled trial and economic analysis

Por: Van Netten · C. · Vallabhaneni · K. · Hardwick · B. · Anumba · D. · Briley · A. L. · Collins · P. · Collis · R. E. · Deja · E. · Gkioni · E. · Gyte · G. · Hickey · H. · Hinshaw · K. · Hughes · D. A. · Kenyon · S. · Lavender · T. · Meher · S. · Plumpton · C. · Robson · S. · Rosala-Hallas · A
Introduction

Excessive bleeding after childbirth (postpartum haemorrhage, PPH) affects 5% of births and causes 75 000 maternal deaths worldwide annually. It is the leading cause of direct maternal deaths globally and continues to be a major cause of mortality in the UK. Oxytocin is the standard first-line treatment for atonic PPH. The PPH rate is increasing, and this may be partially related to the overuse of oxytocics in labour. Laboratory studies on myometrium suggest that repeated use of oxytocics leads to the saturation of oxytocin receptors and reduced therapeutic efficacy of oxytocin. Carboprost (a prostaglandin analogue) is usually reserved for second-line management of atonic PPH. A systematic review comparing the efficacy of carboprost and conventional uterotonics for PPH prophylaxis found that carboprost was associated with less blood loss, but around 15% of women experienced side effects. The study’s aim is to compare intramuscular carboprost with intravenous oxytocin for the initial treatment of PPH. In addition, to assess the cost-effectiveness of both treatments, participants’ views on the two treatments and the consent process.

Methods and analysis

COPE is a double-blind, double-dummy, randomised controlled trial that aims to recruit 2000 women (1:1 allocation, stratified by mode of birth) across 20 hospitals in the UK. Due to the emergency nature of PPH, COPE uses a research without prior consent (RWPC) model. Randomisation and treatment will occur if eligibility criteria are met once bleeding starts. Postnatal consent will be sought for disclosure of identifiable data and continued follow-up. Clinical efficacy outcomes will be collected at 24 and 48 hours or at hospital discharge, if sooner. Questionnaires will also be collected at 24 hours and 4 weeks postrandomisation. Cost-effectiveness will be based on the incremental cost per quality-adjusted life-year, calculated from the perspective of the NHS and personal social services.

Ethics and dissemination

This study has been approved by the Coventry and Warwickshire Research Ethics Committee (REC) (18/WM/0227) and the Health Research Authority. Results will be disseminated via peer-reviewed publications.

Trial registration number

ISRCTN16416766.

Qualitative study exploring stakeholder perspectives on the use of early MRI in wrist injury pathways in the UK NHS

Por: Dean · B. J. F. · Lang · G. · Baird · L. · Grove · A. · Stephens · T. · Toye · F. · Improving Wrist Injury Pathways Study Group · Scrimshire · Little · Riley · Metcalfe · Sellon · Burford · Cadoux-Hudson · Hedley · Gidwani · Brewster · Costa · Lawrie · Rankin · Lipscombe · Berridg
Objectives

Early MRI use varies in the management of acute wrist injuries in the UK, with only a minority of National Health Service (NHS) centres being able to offer this to patients. In this study, we aim to explore the perspectives of staff and patients on the use of early MRI in the management of wrist injuries.

Design

This is a cross-sectional qualitative study using semistructured, face-to-face and remote interviews. Interviews were audio recorded, transcribed verbatim and analysed using thematic analysis.

Setting

10 NHS Trusts in the UK.

Participants

We interviewed a sample consisting of 37 NHS staff members and 21 patients.

Results

We analysed the data into three overarching themes. The first theme described the negative impact of wrist injuries on both staff and patients. Staff reported an uncomfortable feeling that they had ‘short-changed’ patients with older non-MRI based pathways, and that the consequences of missing a scaphoid fracture could be a ‘horrible thing’ for patients. The second theme described how early MRI was perceived as a ‘win for everyone’. For patients, the win encompassed the relief of a speedy diagnosis which helped them to get better. Staff saw early MRI as a win because it ‘revolutionised care’ and ‘reduced the clinic footprint’. The final theme defined the key ingredients of delivering an early MRI pathway: a simple pathway with clear accountability, timely access to MRI and prompt reporting of results, a safe pathway with safety nets to avoid patients being lost, data and audit of the time to MRI and definitive treatment, bottom-up engagement, clear communication and looking after your team.

Conclusions

Our findings contribute to a better understanding of stakeholders’ perspectives on wrist injury pathways in the UK NHS.

Acceptability and feasibility of acceptance and commitment therapy for improving outcomes in hematopoietic stem cell transplant

by Rhonda M. Merwin, Patrick J. Smith, J.A. Riley, Jordan Infield, Christine O’Connell, Dorothy Mayo, Ashley A. Moskovich, Lauren Hill, Hilary Winthrop, Amy Bush, Ernaya Johnson, Francesca Scheiber, Anthony D. Sung

Introduction: Allogeneic hematopoietic stem cell transplant (HCT) has the potential to cure patients with hematologic malignancies, but treatment-related morbidity and mortality is high. Transplant outcomes are optimized by patients maintaining physical activity. The aim of the current study was to examine whether a brief Acceptance and Commitment Therapy (ACT) intervention is acceptable to HCT patients and caregivers and helps patients engage in healthy behavior despite physical and emotional discomfort. Methods: Patients ≥ 18 years of age who were undergoing allogenic HCT for any cancer or non-cancer illness and their caregivers were invited to complete six ACT sessions between transplant day − 30 and day + 90. Multiple small cohorts of n = 3 dyads were enrolled, and the protocol content was iterated after each cohort to reflect the experiences and breadth of concerns of individuals undergoing HCT. Acceptability was indexed by session completion rates and acceptability surveys. Pre-post 6-minute walk distance was collected as an index of physical function as part of standard care. Results: Sixteen HCT dyads enrolled in the study; 12 continued to treatment. Most participants completed all assigned sessions. Participants perceived ACT to be helpful and 70% (5 of 7) of the patients with pre-post 6-minute walk test data showed improvement. Conclusion: ACT is an acceptable and potentially useful intervention for individuals undergoing HCT. Additional controlled studies are warranted.

‘I'm still here, I'm alive and breathing’: The experience of Black Americans with long COVID

Abstract

Aims and Objectives

In this study, we aimed to characterize the impact of long COVID on quality of life and approaches to symptom management among Black American adults.

Background

As a novel condition, qualitative evidence concerning long COVID symptoms and their impact on quality of life can inform the refinement of diagnostic criteria and care plans. However, the underrepresentation of Black Americans in long COVID research is a barrier to achieving equitable care for all long COVID patients.

Design

We employed an interpretive description study design.

Methods

We recruited a convenience sample of 15 Black American adults with long COVID. We analysed the anonymized transcripts from race-concordant, semi-structured interviews using an inductive, thematic analysis approach. We followed the SRQR reporting guidelines.

Results

We identified four themes: (1) The impact of long COVID symptoms on personal identity and pre-existing conditions; (2) Self-management strategies for long COVID symptoms; (3) Social determinants of health and symptom management; and (4) Effects on interpersonal relationships.

Conclusion

Findings demonstrate the comprehensive ramifications of long COVID on the lives of Black American adults. Results also articulate how pre-existing conditions, social risk factors, distrust due to systemic racism, and the nature of interpersonal relationships can complicate symptom management.

Relevance to Clinical Practice

Care approaches that support access to and implementation of integrative therapies may be best suited to meet the needs of long COVID patients. Clinicians should also prioritize eliminating patient exposure to discrimination, implicit bias, and microaggressions. This is of particular concern for long COVID patients who have symptoms that are difficult to objectively quantify, such as pain and fatigue.

No Patient or Public Contribution

While patient perspectives and experiences were the focus of this study, patients were not involved with the design or conduct of the study, data analysis or interpretation, or writing the manuscript.

Key stakeholders' perspectives: A gap analysis of hospital‐acquired pressure injuries

Abstract

Introduction

Hospital-acquired pressure injuries (HAPIs) are a global high-stakes patient safety issue. Key stakeholder perspectives regarding their role and experiences with pressure injuries is critical as part of the solution to minimizing HAPI occurrence and attain sustainability.

Design

A qualitative, descriptive approach provided multiple perspectives of key stakeholders to support the complexity of HAPI care. The qualitative data are a part of a mixed method convergent research study examining pressure injury prevention and management practices.

Methods

Nursing system theory, mixed method convergent design, and participatory action research methodologies were chosen to address both the gap analysis development and results, achieve collaborative comprehensiveness, and enable key stakeholder involvement throughout this HAPI prevention and management initiative. Participants were recruited and enrolled from a large Level I trauma hospital and the key stakeholders. Demographic information were collected prior to the individual interview. Focused interviews were conducted virtually using zoom technology. Qualitative data were analyzed using NVivo software and thematic analysis was confirmed across the co-investigators for congruence and applicability to the research questions.

Results

Qualitative interviews with 26 key stakeholders provided data to support and integrate a link with gap analysis results on the complex health issue of HAPIs. Specific barrier and recommendation themes identified interventions that could be prioritized. The 52 barrier and 52 recommendation themes/sub-theme(s) respectively were organized by Donabedian (structure, process, and outcome) with structure elements the majority. The top three structure barrier themes involved equipment and standards for use, staff prevention education, and specialized health professionals. The top three structure recommendation themes involved specialized health professionals, equipment and standards for use, and an educational plan for those at risk or with HAPIs.

Conclusion

The article provides findings from the qualitative portion of a mixed method study related to HAPIs. The qualitative findings associated with the gap analysis quantitative results, achieved the goal of the participatory action research key stakeholders' input into HAPI care and can be replicated internationally.

Clinical Relevance

The benefit of key stakeholder's involvement in solving a clinical problem is sustainability. A quantitative approach and integrating qualitative stakeholders' perspectives provide an in-depth solution that will advance nursing capacity toward health care delivery and HAPI nursing science and policy development on a global level.

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