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☐ ☆ ✇ Journal of Clinical Nursing

Measurement properties of patient‐reported outcome measures for women with dysmenorrhea: A systematic review

Abstract

Background

Dysmenorrhea, or menstrual pain, is a subjective experience, and can only be assessed by patient-reported outcomes. These instruments should be reliable, valid and responsive.

Aim

To identify and critically appraise the available evidence for the measurement properties of specific patient-reported outcome measures used for dysmenorrhea.

Methods

The PRISMA statement was used to report this systematic review. Databases searched were PubMed, SCOPUS, CINAHL, Web of Science, ScienceDirect and Google Scholar (April 2021; updated on February 2023). Original studies with primary data collection, with no restriction on language and publication date that reported psychometric properties of one or more dysmenorrhea-related patient-reported outcome measure. The literature searches, selection of studies, data extraction and assessment of the risk of bias were performed independently by two reviewers and followed the COSMIN guidelines.

Results

Thirty studies were analysed in this review, and 19 patient-reported outcome measures were evaluated. The instruments varied in relation to the measured construct and measurement properties (validity, reliability and responsiveness). The methodological quality of the studies and the quality of evidence of the patient-reported outcome measures were variable. Among the 13 studies that reported the development of patient-reported outcome measures, most had inadequate methodological quality, and the overall rating was insufficient or inconsistent.

Conclusions

The Dysmenorrhea Symptom Interference (DSI) scale was the only identified patient-reported outcome measure that has the potential to be recommended because of its sufficient rating combined with moderate quality of evidence for content validity. Future studies should further evaluate the measurement properties of the existing patient-reported outcome measures, or develop new patient-reported outcome measures following the COSMIN methodology.

Patient or public contribution

Not applicable as this is a systematic review.

Trial registration

PROSPERO protocol: CRD42021244410. Registration on April 22, 2021.

☐ ☆ ✇ Journal of Clinical Nursing

‘My sexual desires, everything, my normal life just stops’; a qualitative study of male sexual health in inflammatory bowel disease

Por: Sara Ma · Peter Knapp · Paul Galdas — Mayo 27th 2024 at 06:14

Abstract

Aim

To describe and interpret the sexual health experiences of men with IBD.

Design

Interpretive qualitative study.

Methods

In-depth, semi-structured interviews were conducted with 22 men with a diagnosis of Inflammatory Bowel Disease. Interviews were digitally audio-recorded and transcribed verbatim. Data were analysed using constant comparative, thematic analysis.

Results

Three themes were identified from interview data: (1) the disease shapes intimate connections, (2) the disease thwarts sexual experiences and (3) the disease disrupts male gender norms. Men reported that active disease lowered libido and could change pre-, inter- and post-coital sexual practices. All participants noted that health professionals did not initiate the discussion of sexual health and well-being needs in the outpatient hospital setting. Men who engaged in receptive anal sex reported a lack of disease-specific guidance and understanding from professionals.

Conclusion

Inflammatory bowel disease can negatively impact the sexual well-being, gender identity and activities of men. Further research is required to identify the care preferences of men with IBD and clarify the barriers and facilitators to sexual health assessment so that nurses may better support the health needs of this population.

Implications for the Profession and Patient Care

This study highlights the need for sexual health and well-being support that is specific to disease and gender in IBD. There is a paucity of information and guidance for men with peri-anal disease and proctitis who engage in receptive anal sex, which requires urgent attention.

Reporting Method

Reporting follows the COREQ checklist.

Patient or Public Contribution

A patient and public involvement group informed the development of the study design. The group reviewed public facing documents and interview guides. One member of the group provided comments on the identified themes.

☐ ☆ ✇ Journal of Clinical Nursing

Feasibility and acceptability of measuring positivity resonance in nurse–patient telehealth videoconferencing visits: A mixed‐methods observational study

Abstract

Aim

To investigate the feasibility and acceptability of the training process, procedures, measures and recruitment strategies necessary for a future investigation to test the reliability and validity of using positivity resonance measures in health care encounters.

Background

Although the measurement of positivity resonance is promising, and non-participant observation is considered effective, their approaches to studying nurse–patient relationships have not been fully explored.

Design

A mixed-methods observational study.

Methods

Video recordings of 30 nurse–patient dyads completing telehealth video visit encounters were edited and coded using behavioural indicators of positivity resonance. A post-visit survey gathered data on the participants' perceptions of positivity resonance and the study procedures. The research team completed memos and procedural logs to provide narrative data on the study's training, coding, recruitment and operational procedures. The study included 33 persons with cancer and 13 oncology nurses engaging in telehealth video visit encounters at an academic oncology ambulatory care center located in the southeastern United States.

Results

Study procedures were found to be feasible and acceptable to participants. An adequate sample of participants (N = 46) were enrolled and retained in the study. Interrater reliability, as evidenced by Cohen's weighted kappa, ranged from .575 to .752 and interclass correlation coefficients >.8 were attainable within a reasonable amount of time and with adequate training. Behavioural indicators of positivity resonance were observed in all telehealth visits and reported by the participants in the perceived positivity resonance survey. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist guided reporting.

Conclusions

Designing research around the concept of positivity resonance is an innovative and feasible approach to exploring how rapport is cultivated within nurse–patient relationships.

Relevance to Professional Practice

Measuring positivity resonance may hold promise for exploring patient and nurse outcomes including trust, responsiveness, health-related behaviours, well-being, resilience and satisfaction.

Reporting Method

The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist guided the reporting of results to ensure that adequate details of the study were provided to ensure an accurate and complete report.

Patient or Public Contribution

Planning of the research design and study procedures was done in consultation with nurse clinicians with experience with telehealth and managers responsible within the practice setting where the study was conducted. This ensured the study procedures were ethical, safe, secure and did not create unnecessary burden to the study participants. The study included collecting data from nurse and patient participants about the acceptability of the study procedures.

☐ ☆ ✇ Journal of Clinical Nursing

Promoting speaking‐up behaviours among nurses working in the care for older people: A scoping review

Por: Katrina Austen · Marie Hutchinson · John Hurley — Abril 30th 2024 at 08:29

Abstract

Aim

To explore interventions employed to foster speaking-up behaviours of registered nurses (RNs) working in the care of older people.

Design

Scoping review.

Methods

The updated Joann Briggs Institute scoping review methodological guidelines were followed.

Data Sources

CINAHL, PubMed, PsycINFO, and Scopus were searched.

Results

A total of 1691 titles and abstracts were screened, resulting in 11 articles that met the inclusion criteria. Analysis focused upon intervention types, methodologies, speaking up strategies, barriers and effectiveness. Education was the most used intervention.

Conclusion

There is a lack of published research on successful interventions to promote speaking-up behaviours in the care of older people, particularly relating to poor care practices. Evidence of speaking-up interventions in the residential aged care setting is absent. This highlights the need to develop strategies to support the RN to lead and enable others to raise care concerns.

Implications for the Profession and/or Patient Care

Developing strategies that enable staff, care recipients and their families to speak up about care concerns is a vital future area for nursing practice development. Nursing leadership of such strategies is central to improving the quality of care for older people, particularly those living in residential aged care.

Impact

Older people receiving care should feel respected and be treated humanely. Evidence suggests this is often not the case. This review found a paucity of interventions to promote speaking-up about poor care practices among RNs working in the care of older people. Future research needs to address this, to empower RNs and improve the care afforded to older people.

Reporting Method

The PRISMA-ScR (Tricco et al., Annals of Internal Medicine, 169, 467–473, 2018) were adhered to throughout this scoping review.

Patient or Public Contribution

No patient or public contribution in this review.

☐ ☆ ✇ Journal of Clinical Nursing

The role of nurse–patient mutuality on self‐care behaviours in patients with chronic illness

Abstract

Aim

To examine the role of nurse–patient mutuality on three self-care behaviours in chronic illness patients.

Design

A cross-sectional multi-centre study was conducted.

Methods

Mutuality was measured with the Nurse–Patient Mutuality in Chronic Illness scale which has the dimensions of developing and going beyond, being a point of reference and deciding and sharing care, and self-care was measured with the Self-care of Chronic Illness Inventory (SC-CII). Multivariable linear regression analyses were used to assess the contribution of three dimensions of mutuality on self-care maintenance, monitoring and management behaviours controlling for patient gender, age, education, number of medications, and presence of a family caregiver.

Results

The sample included 465 inpatients and outpatients with at least one chronic illness. The three dimensions of mutuality had different roles in their influence on the three dimensions of self-care. Developing and going beyond was significantly associated with self-care maintenance and self-care monitoring behaviours. Point of reference was significantly associated with self-care maintenance behaviour. Deciding and sharing care was significantly associated with self-care monitoring and self-care management behaviours.

Conclusion

The mutuality between nurse and patient may be a novel area of research to support and improve patient self-care behaviours with implications for clinical practice and education.

Implication for Profession and Patient Care

Mutuality between nurse and patient increases patient engagement, symptom recognition, decision-making process and patient-centred approach favouring the development of self-care behaviours.

Impact

Mutuality between nurse and patient is a new concept and its association with the patient outcomes could bring relevance to the nursing profession. Self-care behaviours are important in the management of chronic diseases, but are difficult to perform. Mutuality between nurse and patient influences the three different behaviours of self-care in chronic illness, for this reason it is important to increase the level of mutuality in this dyad.

Reporting Method

STROBE checklist for cross-sectional studies was followed in this study.

Patient or Public Contribution

Patients were involved in the sample of the study.

☐ ☆ ✇ PLOS ONE Medicine&Health

Untargeted lipidomics analysis in women with morbid obesity and type 2 diabetes mellitus: A comprehensive study

Por: Laia Bertran · Jordi Capellades · Sonia Abelló · Carmen Aguilar · Teresa Auguet · Cristóbal Richart — Mayo 14th 2024 at 16:00

by Laia Bertran, Jordi Capellades, Sonia Abelló, Carmen Aguilar, Teresa Auguet, Cristóbal Richart

There is a phenotype of obese individuals termed metabolically healthy obese that present a reduced cardiometabolic risk. This phenotype offers a valuable model for investigating the mechanisms connecting obesity and metabolic alterations such as Type 2 Diabetes Mellitus (T2DM). Previously, in an untargeted metabolomics analysis in a cohort of morbidly obese women, we observed a different lipid metabolite pattern between metabolically healthy morbid obese individuals and those with associated T2DM. To validate these findings, we have performed a complementary study of lipidomics. In this study, we assessed a liquid chromatography coupled to a mass spectrometer untargeted lipidomic analysis on serum samples from 209 women, 73 normal-weight women (control group) and 136 morbid obese women. From those, 65 metabolically healthy morbid obese and 71 with associated T2DM. In this work, we find elevated levels of ceramides, sphingomyelins, diacyl and triacylglycerols, fatty acids, and phosphoethanolamines in morbid obese vs normal weight. Conversely, decreased levels of acylcarnitines, bile acids, lyso-phosphatidylcholines, phosphatidylcholines (PC), phosphatidylinositols, and phosphoethanolamine PE (O-38:4) were noted. Furthermore, comparing morbid obese women with T2DM vs metabolically healthy MO, a distinct lipid profile emerged, featuring increased levels of metabolites: deoxycholic acid, diacylglycerol DG (36:2), triacylglycerols, phosphatidylcholines, phosphoethanolamines, phosphatidylinositols, and lyso-phosphatidylinositol LPI (16:0). To conclude, analysing both comparatives, we observed decreased levels of deoxycholic acid, PC (34:3), and PE (O-38:4) in morbid obese women vs normal-weight. Conversely, we found elevated levels of these lipids in morbid obese women with T2DM vs metabolically healthy MO. These profiles of metabolites could be explored for the research as potential markers of metabolic risk of T2DM in morbid obese women.
☐ ☆ ✇ Worldviews on Evidence-Based Nursing

Social media use and its impact on adult's mental health and well‐being: A scoping review

Abstract

Background

Social media use has grown in importance and prevalence, with its estimated number of users at 4.9 billion worldwide. Social media use research has revealed positive and negative impacts on users' mental health and well-being. However, such impacts among adults have not been examined in any reviews.

Methods

A scoping review was conducted based on the framework by Arksey and O'Malley and reported based on the PRISMA-ScR guidelines. Eight databases were searched from 2005 to December 2021. Articles were included after being reviewed by three independent teams, with discrepancies resolved through consensus with the senior author. Publication-related information (i.e., authors, year of publication, aims, study population, methodology, interventions, comparisons, outcome measures and key findings) were extracted from each study. Thematic analysis was conducted to answer the research questions.

Results

Among the 114 eligible articles, young adults (69.6%) represented the main age group. Most studies (78.6%) focused on the negative impacts of social media use on mental health and well-being, with nearly a third (32.1%) assessing such impacts on depression. Notably, this scoping review found that more than three-quarters (78.6%) of the included studies revealed that excessive and passive social media use would increase depression, anxiety, mood, and loneliness. Nevertheless, a third (33.0%) also reported positive impacts, where positive and purposeful use of social media would contribute to improvements in mental health and well-being, such as increased perceived social support and enjoyment.

Linking Evidence to Action

This review has provided an overview of the existing knowledge on how social media use would affect adults and identified areas of research that merit investigations in future studies. More attention should be given to maximizing the positive impacts of social media use on mental health and well-being among adults.

☐ ☆ ✇ Journal of Advanced Nursing

Nursing/midwifery students' perceptions of caring pedagogy and online learning during the COVID‐19 pandemic

Abstract

Aim

This study aimed to gain a better understanding of nursing/midwifery students' perspectives on a pedagogy of caring and online learning during the COVID-19 pandemic. In addition, it aimed to determine if the COVID-19 pandemic impacted students' perceptions and experience of online learning and students' desire to enter the nursing/midwifery workforce.

Design

Mixed methods.

Methods

A multi-centre cross-sectional survey of Australian nursing and midwifery students was undertaken to explore students’ experience of learning during the COVID-19 pandemic.

Results

There are several key findings from this study that may be relevant for the future delivery of undergraduate health education, students transitioning to practice and healthcare workforce retention. The study found that although students were somewhat satisfied with online learning during COVID-19, students reported significant issues with knowledge/skill acquisition and barriers to the learning process. The students reported feeling less prepared for practice and identified how clinical staff were unable to provide additional guidance and support due to increased workloads and stress. The textual responses of participants highlighted that connection/disconnection, empathy and engagement/disengagement had an impact on learning during COVID-19.

Conclusion

Connection, engagement and isolation were key factors that impacted nursing students’ online learning experiences. In addition, graduates entering the workforce felt less prepared for entry into practice due to changes in education delivery during COVID-19 that they perceived impacted their level of clinical skills, confidence and ability to practice as new graduate nurses/midwives.

Patient or Public Contribution

Not applicable.

Impact

Attention must be given to the transition of new graduate nurses and midwives whose education was impacted by pandemic restrictions, to support their professional career development and to ensure retention of future healthcare workforce. Connection, engagement and isolation were key factors that impacted nursing students' online learning experiences. Educators should consider how connection and engagement can be actively embedded in the online learning environment.

☐ ☆ ✇ Journal of Advanced Nursing

Comparison of student nurses' expectations and newly qualified nurses' experiences regarding clinical practice: A secondary analysis of a cross‐sectional survey

Abstract

Aim

To compare student nurses' expectations and newly qualified nurses' experiences regarding clinical practice in Switzerland 1 year after graduation.

Design

A secondary explorative analysis of a cross-sectional survey.

Methods

The data were sourced from the Swiss National Graduate Survey of Health Professionals covering six universities of applied sciences between 2016 and 2019, with information on three cohorts of bachelor student nurses, with a 1-year follow-up between each year. The participants were 533 bachelor-prepared nursing graduates.

Results

The student nurses' overall expectations included the following top two prioritized aspects: ‘contributing to something important’ and ‘adequate time to spend with patients’. Newly graduated nurses' clinical practice experiences demonstrated that not all expectations were met 1 year after graduation. The largest gaps were found in ‘adequate time to spend with patients’, ‘work–life balance’ and experiencing ‘good management’.

Conclusion

The most crucial expectation gaps are related to having sufficient time to spend with patients and a good work–life balance. The most important result is whether there is a shortage of places for nurses to work rather than the oft-cited shortage of nurses.

Implications for the Profession and/or Patient Care

The expectations of Swiss newly qualified nurses can be better met by an assessment in the first year about which individual perceptions of workplace characteristics cause them to make choices to change something about their work, affect their job satisfaction or influence their intention to stay.

Impact

Few of the student nurses' expectations were met 1 year after graduation, therefore Swiss healthcare institutions should improve needs assessments to strengthen the nurse workforce starting early in employment. The results underscore the importance of a constructive management culture, such as that in magnet hospitals in the United States which underpins the philosophy of changing in nursing. The results can be used internationally as a benchmark and as a basis for introducing potential interventions for nurse retention.

Reporting Method

This study was reported following the Standardized Reporting of Secondary Data Analyses Checklist.

Patient or Public Contribution

There were no patient or public contributions.

Trial and Protocol Registration

This study has not been registered.

☐ ☆ ✇ Nursing Research

Nursing Science: This I (Still) Believe

Por: Wickline · Mihkaila Maurine — Mayo 1st 2024 at 02:00
No abstract available
☐ ☆ ✇ BMJ Open

Cognitive stimulation for people with dementia in nursing homes: a protocol for a feasibility study examining a new 24/7 approach (CogStim24)

Por: Folkerts · A.-K. · Seven · U. S. · Guicheteau · J. · N Dichter · M. · Hellmich · M. · Köpke · S. · Kalbe · E. — Mayo 9th 2024 at 19:25
Introduction

Based on the available evidence, cognitive stimulation is recommended as an intervention for people with dementia (PwD). Currently, cognitive stimulation is regularly offered as a group programme in care facilities. However, some residents, such as those who are bedridden, cannot participate. Furthermore, group programmes were not feasible during the pandemic. A concept that accompanies everyday life and enables cognitive stimulation in everyday communication (ie, ‘24/7’) has been missing. Therefore, this feasibility study aims to (1) assess the feasibility of a new continuous 24/7 cognitive stimulation programme (CogStim24) based on a process evaluation and (2) examine the possible effects of CogStim24 on the primary outcome of global cognition in PwD and further PwD-related and staff-related outcomes.

Methods and analysis

The complex CogStim24 programme is developed to be conducted as an everyday intervention during routine care including cognitively stimulating techniques, such as reminiscence therapy, multisensory stimulation and physical activity. In this unblinded single-arm study with pre-assessments and post-assessments, four nursing homes with a total of N=20 nursing and care staff will participate in an 11-week CogStim24 training programme. The intervention will be conducted to N=60 PwD. Neuropsychological assessments will be conducted pre-staff and post-staff training, as well as after a 6-week implementation phase. A process evaluation will be performed.

Ethics and dissemination

Ethics approval was obtained from the ethics committee of the Faculty of Medicine of the University of Cologne, Cologne, Germany. Although cognitive stimulation is known to be effective for enhancing global cognition and quality of life in PwD, it is currently undersupplied to PwD. Therefore, CogStim24 has the potential to reach many more PwD. This study has the potential to serve as a basis for a large multicentre cluster randomised controlled trial. An interdisciplinarity team and mixed-methods approach will help generate information on the practicality and mechanisms of impact of CogStim24. This is important for the further development of the intervention and for facilitating its implementation. The study results will be disseminated via presentations at scientific conferences and meetings for healthcare professionals and PwD and their relatives. Several manuscripts presenting results of the different study parts will be published in peer-reviewed journals.

Trial registration number

DRKS00024381.

☐ ☆ ✇ BMJ Open

Use of artificial intelligence in obstetric and gynaecological diagnostics: a protocol for a systematic review and meta-analysis

Por: Chaurasia · A. · Curry · G. · Zhao · Y. · Dawoodbhoy · F. · Green · J. · Vaninetti · M. · Shah · N. · Greer · O. — Mayo 8th 2024 at 17:36
Introduction

Emerging developments in applications of artificial intelligence (AI) in healthcare offer the opportunity to improve diagnostic capabilities in obstetrics and gynaecology (O&G), ensuring early detection of pathology, optimal management and improving survival. Consensus on a robust AI healthcare framework is crucial for standardising protocols that promote data privacy and transparency, minimise bias, and ensure patient safety. Here, we describe the study protocol for a systematic review and meta-analysis to evaluate current applications of AI in O&G diagnostics with consideration of reporting standards used and their ethical implications. This protocol is written following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 checklist.

Methods and analysis

The study objective is to explore the current application of AI in O&G diagnostics and assess the reporting standards used in these studies. Electronic bibliographic databases MEDLINE, EMBASE and Cochrane will be searched. Study selection, data extraction and subsequent narrative synthesis and meta-analyses will be carried out following the PRISMA-P guidelines. Included papers will be English-language full-text articles from May 2015 to March 2024, which provide original data, as AI has been redefined in recent literature. Papers must use AI as the predictive method, focusing on improving O&G diagnostic outcomes.

We will evaluate the reporting standards including the risk of bias, lack of transparency and consider the ethical implications and potential harm to patients. Outcome measures will involve assessing the included studies against gold-standard criteria for robustness of model development (Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis, model predictive performance, model risk of bias and applicability (Prediction model Risk Of Bias Assessment Tool and study reporting (Consolidated Standards of Reporting Trials-AI) guidance.

Ethics and dissemination

Ethical approval is not required for this systematic review. Findings will be shared through peer-reviewed publications.There will be no patient or public involvement in this study.

PROSPERO registration number

CRD42022357024.

☐ ☆ ✇ BMJ Open

Cohort profile: the Environmental Reproductive and Glucose Outcomes (ERGO) Study (Boston, Massachusetts, USA) -- a prospective pregnancy cohort study of the impacts of environmental exposures on parental cardiometabolic health

Por: Preston · E. V. · Quinn · M. R. · Williams · P. L. · McElrath · T. F. · Cantonwine · D. E. · Seely · E. W. · Wylie · B. J. · Hacker · M. R. · O'Brien · K. · Brown · F. M. · Powe · C. E. · Bellavia · A. · Wang · Z. · Tomsho · K. S. · Hauser · R. · James-Todd · T. · the Environmental Rep — Mayo 8th 2024 at 17:36
Purpose

Pregnancy and the postpartum period are increasingly recognised as sensitive windows for cardiometabolic disease risk. Growing evidence suggests environmental exposures, including endocrine-disrupting chemicals (EDCs), are associated with an increased risk of pregnancy complications that are associated with long-term cardiometabolic risk. However, the impact of perinatal EDC exposure on subsequent cardiometabolic risk post-pregnancy is less understood. The Environmental Reproductive and Glucose Outcomes (ERGO) Study was established to investigate the associations of environmental exposures during the perinatal period with post-pregnancy parental cardiometabolic health.

Participants

Pregnant individuals aged ≥18 years without pre-existing diabetes were recruited at

Findings to date

We enrolled 653 unique pregnancies and retained 633 through delivery. Participants had a mean age of 33 years, 10% (n=61) developed gestational diabetes and 8% (n=50) developed pre-eclampsia. Participant pregnancy and postpartum urinary phthalate metabolite concentrations and postpartum glycaemic biomarkers were quantified. To date, studies within ERGO found higher exposure to phthalates and phthalate mixtures, and separately, higher exposure to radioactive ambient particulate matter, were associated with adverse gestational glycaemic outcomes. Additionally, certain personal care products used in pregnancy, notably hair oils, were associated with higher urinary phthalate metabolite concentrations, earlier gestational age at delivery and lower birth weight.

Future plans

Future work will leverage the longitudinal data collected on pregnancy and cardiometabolic outcomes, environmental exposures, questionnaires, banked biospecimens and paediatric data within the ERGO Study.

☐ ☆ ✇ BMJ Open

Comprehensive observational study evaluating the enduring effectiveness of 4CMenB, the meningococcal B vaccine against gonococcal infections in the Northern Territory and South Australia, Australia: study protocol

Por: Marshall · H. · Ward · J. · Wang · B. · Andraweera · P. · McMillan · M. · Flood · L. · Bell · C. · Sisnowski · J. · Krause · V. · Webby · R. · Childs · E. · Gunathilake · M. · Egoroff · N. · Leong · L. · Lawrence · A. · Baird · R. · Freeman · K. · Menouhos · D. · Whiley · D. M. · Karnon · J. — Mayo 8th 2024 at 17:36
Introduction

The effectiveness of antibiotics for treating gonococcal infections is compromised due to escalating antibiotic resistance; and the development of an effective gonococcal vaccine has been challenging. Emerging evidence suggests that the licensed meningococcal B (MenB) vaccine, 4CMenB is effective against gonococcal infections due to cross-reacting antibodies and 95% genetic homology between the two bacteria, Neisseria meningitidis and Neisseria gonorrhoeae, that cause the diseases. This project aims to undertake epidemiological and genomic surveillance to evaluate the long-term protection of the 4CMenB vaccine against gonococcal infections in the Northern Territory (NT) and South Australia (SA), and to determine the potential benefit of a booster vaccine doses to provide longer-term protection against gonococcal infections.

Methods and analyses

This observational study will provide long-term evaluation results of the effectiveness of the 4CMenB vaccine against gonococcal infections at 4–7 years post 4CMenB programme implementation. Routine notifiable disease notifications will be the basis for assessing the impact of the vaccine on gonococcal infections. Pathology laboratories will provide data on the number and percentage of N. gonorrhoeae positive tests relative to all tests administered and will coordinate molecular sequencing for isolates. Genome sequencing results will be provided by SA Pathology and Territory Pathology/New South Wales Health Pathology, and linked with notification data by SA Health and NT Health. There are limitations in observational studies including the potential for confounding. Confounders will be analysed separately for each outcome/comparison.

Ethics and dissemination

The protocol and all study documents have been reviewed and approved by the SA Department for Health and Well-being Human Research Ethics Committee (HREC/2022/HRE00308), and the evaluation will commence in the NT on receipt of approval from the NT Health and Menzies School of Health Research Human Research Ethics Committee. Results will be published in peer-reviewed journals and presented at scientific meetings and public forums.

☐ ☆ ✇ BMJ Open

Strategies for optimising early detection and obstetric first response management of postpartum haemorrhage at caesarean birth: a modified Delphi-based international expert consensus

Por: Pingray · V. · Williams · C. R. · Al-beity · F. M. A. · Abalos · E. · Arulkumaran · S. · Blumenfeld · A. · Carvalho · B. · Deneux-Tharaux · C. · Downe · S. · Dumont · A. · Escobar · M. F. · Evans · C. · Fawcus · S. · Galadanci · H. S. · Hoang · D.-T. T. · Hofmeyr · G. J. · Homer · C. · L — Mayo 8th 2024 at 17:36
Objective

There are no globally agreed on strategies on early detection and first response management of postpartum haemorrhage (PPH) during and after caesarean birth. Our study aimed to develop an international expert’s consensus on evidence-based approaches for early detection and obstetric first response management of PPH intraoperatively and postoperatively in caesarean birth.

Design

Systematic review and three-stage modified Delphi expert consensus.

Setting

International.

Population

Panel of 22 global experts in PPH with diverse backgrounds, and gender, professional and geographic balance.

Outcome measures

Agreement or disagreement on strategies for early detection and first response management of PPH at caesarean birth.

Results

Experts agreed that the same PPH definition should apply to both vaginal and caesarean birth. For the intraoperative phase, the experts agreed that early detection should be accomplished via quantitative blood loss measurement, complemented by monitoring the woman’s haemodynamic status; and that first response should be triggered once the woman loses at least 500 mL of blood with continued bleeding or when she exhibits clinical signs of haemodynamic instability, whichever occurs first. For the first response, experts agreed on immediate administration of uterotonics and tranexamic acid, examination to determine aetiology and rapid initiation of cause-specific responses. In the postoperative phase, the experts agreed that caesarean birth-related PPH should be detected primarily via frequently monitoring the woman’s haemodynamic status and clinical signs and symptoms of internal bleeding, supplemented by cumulative blood loss assessment performed quantitatively or by visual estimation. Postoperative first response was determined to require an individualised approach.

Conclusion

These agreed on proposed approaches could help improve the detection of PPH in the intraoperative and postoperative phases of caesarean birth and the first response management of intraoperative PPH. Determining how best to implement these strategies is a critical next step.

☐ ☆ ✇ BMJ Open

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 — Mayo 8th 2024 at 00:30
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.

☐ ☆ ✇ BMJ Open

Defining practices suitable for care via teleconsultation in gynaecological and obstetrical care: a French Delphi survey

Por: Rousseau · A. · Baumann · S. · Constant · J. · Deplace · S. · Multon · O. · Lenoir-Delpierre · L. · Gaucher · L. — Mayo 7th 2024 at 18:05
Objective

Delineate the scope of teleconsultation services that can be effectively performed to provide women with comprehensive gynaecological and obstetrical care.

Design

Based on the literature and experts’ insights, we identified a list of gynaecological and obstetrical care practices suitable for teleconsultation. A three-round Delphi consensus survey was then conducted online among a panel of French experts. Experts using a 9-point Likert scale assessed the relevance of each teleconsultation practice in four key domains: prevention, gynaecology and antenatal and postnatal care. Consensus was determined by applying a dual-criteria approach: the median score on a 9-point Likert scale and the percentage of votes either below 5 or 5 and higher.

Setting

The study was conducted at a national level in France and involved multiple healthcare centres and professionals from various geographical locations.

Participants

The panel comprised 22 French experts with 19 healthcare professionals, including 12 midwives, 3 obstetricians-gynaecologists, 4 general practitioners and 3 healthcare system users. Participants were selected to include diverse practice settings encompassing hospital and private practices in both rural and urban areas.

Primary and secondary outcome measures

The study’s primary outcome was the identification of gynaecological and obstetrical care practices suitable for teleconsultation. Secondary outcomes included the level of professional consensus on these practices.

Results

In total, 71 practices were included in the Delphi survey. The practices approved for teleconsultation were distributed as follows: 92% in prevention (n=12/13), 55% in gynaecology (n=18/33), 31% in prenatal care (n=5/16) and 12% in postnatal care (n=1/9). Lastly, 10 practices remained under discussion: 7 in gynaecology, 2 in prenatal care and 1 in postnatal care.

Conclusions

Our consensus survey highlights both the advantages and limitations of teleconsultations for women’s gynaecological and obstetrical care, emphasising the need for careful consideration and tailored implementation.

☐ ☆ ✇ BMJ Open

Risk and time preferences in individuals with lifestyle-related and non-lifestyle-related cardiovascular diseases: a pilot study

Por: Kairies-Schwarz · N. · Mussio · I. · Bulla-Holthaus · N. · Wankmüller · E. · Wolff · G. · Gontscharuk · V. · Heinen · Y. · Perings · S. · Brockmeyer · M. · Kelm · M. · Icks · A. — Mayo 7th 2024 at 18:05
Objectives

To (1) pilot a study of behavioural characterisation based on risk and time preferences in clinically well-characterised individuals, (2) assess the distribution of preferences in this population and (3) explore differences in preferences between individuals with ‘lifestyle-related’ (LS) and ‘non-lifestyle-related’ (NLS) cardiovascular diseases.

Design

Cross-sectional study with an economic online experiment to collect risk and time preferences, a detailed clinical characterisation and a sociodemographic and lifestyle survey. A definition of LS and NLS groups was developed.

Setting

Specialist outpatient clinics of the clinic for cardiology and pneumology of the University Hospital Düsseldorf and patients from a cardiology practice in Düsseldorf.

Participants

A total of 74 individuals with cardiovascular diseases.

Outcomes

Risk and time preferences.

Results

The implementation of the study process, including participant recruitment and data collection, ran smoothly. The medical checklist, the survey and the time preference instrument were well received. However, the conceptual understanding of the risk preference instrument resulted in inconsistent choices for many participants (47%). The remaining individuals were more risk averse (27%) than risk seeking (16%) and risk neutral (10%). Individuals in our sample were also more impatient (49%) than patient (42%). The participant classification showed that 65% belonged to the LS group, 19% to the NLS group and 16% could not be assigned (unclear allocation to lifestyle (ULS) group). Excluding the ULS group, we show that individuals in the LS group were more risk seeking, and unexpectedly, more patient than those in the NLS group.

Conclusions

The process of the pilot study and its results can be used as a basis for the design of the main study. The differences in risk and time preferences between the LS and NLS groups provide us with a novel hypothesis for unhealthy behaviours: individuals never give up a bad habit, they simply postpone the latter, which can be tested alongside other additional research questions.

☐ ☆ ✇ BMJ Open

Implementation of the WHO Safe Childbirth Checklist: a scoping review protocol

Por: Gama · Z. A. d. S. · Lima · M. T. S. d. · Semrau · K. E. A. · Tuller · D. E. · Fifield · J. · Fernandez-Elorriaga · M. · Saraiva · C. O. P. d. O. · Freitas · M. R. d. · Pellense · M. C. d. S. · Rosendo · T. M. S. d. S. · Molina · R. L. — Mayo 7th 2024 at 18:05
Introduction

The WHO Safe Childbirth Checklist (WHO SCC) was developed to accelerate adoption of essential practices that prevent maternal and neonatal morbidity and mortality during childbirth. This study aims to summarise the current landscape of organisations and facilities that have implemented the WHO SCC and compare the published strategies used to implement the WHO SCC implementation in both successful and unsuccessful efforts.

Methods and analysis

This scoping review protocol follows the guidelines of the Joanna Briggs Institute. Data will be collected and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews report. The search strategy will include publications from the databases Scopus, PubMed, Embase, CINAHL and Web of Science, in addition to a search in grey literature in The National Library of Australia’s Trobe, DART-Europe E-Theses Portal, Electronic Theses Online Service, Theses Canada, Google Scholar and Theses and dissertations from Latin America. Data extraction will include data on general information, study characteristics, organisations involved, sociodemographic context, implementation strategies, indicators of implementation process, frameworks used to design or evaluate the strategy, implementation outcomes and final considerations. Critical analysis of implementation strategies and outcomes will be performed with researchers with experience implementing the WHO SCC.

Ethics and dissemination

The study does not require an ethical review due to its design as a scoping review of the literature. The results will be submitted for publication to a scientific journal and all relevant data from this study will be made available in Dataverse.

Trial registration number

https://doi.org/10.17605/OSF.IO/RWY27.

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