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Protocol for the Adolescent Menstrual Experiences and Health Cohort (AMEHC) Study in Khulna, Bangladesh: A Prospective cohort to quantify the influence of menstrual health on adolescent girls health and education outcomes.

Por: Hennegan · J. · Hasan · M. T. · Jabbar · A. · Jalil · T. · Kennedy · E. · Hunter · E. · Kaiser · A. · Akter · S. · Zaman · A. · Rahman · M.-u. · Dunstan · L. · Head · A. · Scott · N. · Weiss · H. A. · Win · T. M. · Melendez-Torres · G. J. · Than · K. K. · Hughes · C. L. · Grover · S. · Hasan
Background

Menstrual health is essential for gender equity and the well-being of women and girls. Qualitative research has described the burden of poor menstrual health on health and education; however, these impacts have not been quantified, curtailing investment. The Adolescent Menstrual Experiences and Health Cohort (AMEHC) Study aims to describe menstrual health and its trajectories across adolescence, and quantify the relationships between menstrual health and girls’ health and education in Khulna, Bangladesh.

Methods and analysis

AMEHC is a prospective longitudinal cohort of 2016 adolescent girls recruited at the commencement of class 6 (secondary school, mean age=12) across 101 schools selected through a proportional random sampling approach. Each year, the cohort will be asked to complete a survey capturing (1) girls’ menstrual health and experiences, (2) support for menstrual health, and (3) health and education outcomes. Survey questions were refined through qualitative research, cognitive interviews and pilot survey in the year preceding the cohort. Girls’ guardians will be surveyed at baseline and wave 2 to capture their perspectives and household demographics. Annual assessments will capture schools’ water, sanitation and hygiene, and support for menstruation and collect data on participants’ education, including school attendance and performance (in maths, literacy). Cohort enrolment and baseline survey commenced in February 2023. Follow-up waves are scheduled for 2024, 2025 and 2026, with plans for extension. A nested subcohort will follow 406 post-menarche girls at 2-month intervals throughout 2023 (May, August, October) to describe changes across menstrual periods. This protocol outlines a priori hypotheses regarding the impacts of menstrual health to be tested through the cohort.

Ethics and dissemination

AMEHC has ethical approval from the Alfred Hospital Ethics Committee (369/22) and BRAC James P Grant School of Public Health Institutional Review Board (IRB-06 July 22-024). Study materials and outputs will be available open access through peer-reviewed publication and study web pages.

Evidence-informed and consensus-based statements about SAFEty of Physical Agent Modalities Practice in physiotherapy and rehabilitation medicine (SAFE PAMP): a national Delphi of healthcare scientific societies

Por: Gianola · S. · Bargeri · S. · Pellicciari · L. · Gambazza · S. · Rossettini · G. · Fulvio · A. · Genovese · V. · Benedini · M. · Proverbio · E. · Cecchetto · S. · Castellini · G. · Turolla · A. · SAFE PAMP Collaborators · Torresetti · Masturzo · Berliri · Roselli · Vercelli · Scorcu
Objective

A shared consensus on the safety about physical agent modalities (PAMs) practice in physiotherapy and rehabilitation is lacking. We aimed to develop evidence-informed and consensus-based statements about the safety of PAMs.

Study design and setting

A RAND-modified Delphi Rounds’ survey was used to reach a consensus. We established a steering committee of the Italian Association of Physiotherapy (Associazione Italiana di Fisioterapia) to identify areas and questions for developing statements about the safety of the most commonly used PAMs in physiotherapy and rehabilitation. We invited 28 National Scientific and Technical Societies, including forensics and lay members, as a multidisciplinary and multiprofessional panel of experts to evaluate the nine proposed statements and formulate additional inputs. The level of agreement was measured using a 9-point Likert scale, with consensus in the Delphi Rounds assessed using the rating proportion with a threshold of 75%.

Results

Overall, 17 (61%) out of 28 scientific and technical societies participated, involving their most representative members. The panel of experts mainly consisted of clinicians (88%) with expertise in musculoskeletal (47%), pelvic floor (24%), neurological (18%) and lymphatic (6%) disorders with a median experience of 30 years (IQR=17–36). Two Delphi rounds were necessary to reach a consensus. The final approved criteria list comprised nine statements about the safety of nine PAMs (ie, electrical stimulation neuromodulation, extracorporeal shock wave therapy, laser therapy, electromagnetic therapy, diathermy, hot thermal agents, cryotherapy and therapeutic ultrasound) in adult patients with a general note about populations subgroups.

Conclusions

The resulting consensus-based statements inform patients, healthcare professionals and policy-makers regarding the safe application of PAMs in physiotherapy and rehabilitation practice. Future research is needed to extend this consensus on paediatric and frail populations, such as immunocompromised patients.

A standardized wound infection model for antimicrobial testing of wound dressings in vitro

Abstract

To investigate the effectiveness of antimicrobial agents against wound infections, experiments using either 2D cultures with planktonic microorganisms or animal infection models are frequently carried out. However, the transferability of the results to human skin is limited by the lack of complexity of the 2D models or by the poor translation of the results from animal models. Hence, there is a need for wound infection models capable of assessing antimicrobial agents. In this study, an easily standardized wound infection model was established. This model consists of a mechanically wounded human skin model on a collagen matrix infected with various clinically relevant bacteria. Infection of the model led to recognition of the pathogens and induction of an inflammatory response. The untreated infection spread over time, causing significant tissue damage. By applying an antimicrobial-releasing wound dressing, the bacterial load could be reduced and the success of the treatment could be further measured by a decrease in the inflammatory reaction. In conclusion, this wound infection model can be used to evaluate new antimicrobial therapeutics as well as to study host-pathogen interactions.

Pressure injury risk assessment and prescription of preventative interventions using a structured tool versus clinical judgement: An interrater agreement study

Abstract

Aim

To assess agreement of pressure injury risk level and differences in preventative intervention prescription between nurses using a structured risk assessment tool compared with clinical judgement.

Design

Interrater agreement study.

Methods

Data were collected from November 2019 to December 2022. Paired nurse-assessors were allocated randomly to independently assess pressure injury risk using a structured tool (incorporating the Waterlow Score), or clinical judgement; then prescribe preventative interventions. Assessments were conducted on 150 acute patient participants in a general tertiary hospital. Agreement of risk level was analysed using absolute agreement proportions, weighted kappa and prevalence-adjusted and bias-adjusted kappa.

Results

Ninety-four nurse assessors participated. Absolute agreement of not-at-risk versus at-risk-any-level was substantial, but absolute agreement of risk-level was only fair. Clinical judgement assessors tended to underestimate risk. Where risk level was agreed, prescribed intervention frequencies were similar, although structured tool assessors prescribed more interventions mandated by standard care, while clinical judgement assessors prescribed more additional/optional interventions. Structured tool assessors prescribed more interventions targeted at lower-risk patients, whereas assessors using clinical judgement prescribed more interventions targeted at higher-risk patients.

Conclusion

There were clear differences in pressure injury risk-level assessment between nurses using the two methods, with important differences in intervention prescription frequencies found. Further research is required into the use of both structured tools and clinical judgement to assess pressure injury risk, with emphasis on the impact of risk assessments on subsequent preventative intervention implementation.

Impact

The results of this study are important for clinical practice as they demonstrate the influence of using a structured pressure injury risk assessment tool compared to clinical judgement. Whilst further research is required into the use of both structured tools and clinical judgement to assess pressure injury risk and prescribe interventions, our findings do not support a change in practice that would exclude the use of a structured pressure injury risk assessment tool.

Reporting Method

This study adhered to the GRRAS reporting guideline.

Patient/Public Contribution

No patient or public involvement in this study.

Implications for the profession and/or patient care

Educators and researchers can use the findings to guide teaching about pressure injury risk assessment and preventative intervention and to direct future studies. For clinical nurses and patients, a change in clinical practice that would exclude the use of a structured risk assessment tool is not recommended and further work is needed to validate the role of clinical judgement to assess risk and its impact on preventative intervention.

Living with unsettled baby behaviours: Qualitative interview study exploring parental perceptions and experiences of help‐seeking

Abstract

Aim

To explore parents' perceptions/experiences of help-seeking for unsettled baby behaviours, including views and experiences of obtaining advice from primary healthcare professionals.

Design

Semi-structured qualitative interviews.

Methods

Recruitment occurred via social media, general practice and health visiting teams. Remote semi-structured interviews were conducted with parents of babies. Babies were under 12 months old at time of interview, and parents had perceived unsettled baby behaviours in their first 4 months of life. Interviews were transcribed and data analysed using reflexive thematic analysis.

Results

Based on interviews with 25 mothers, four main themes were developed. ‘The need for answers’ highlighted parental uncertainty about what constitutes normal baby behaviour, leading to help-seeking from multiple sources. ‘The importance of health professionals’ and ‘Experiencing health professional support’ identified perceptions about limited access, communication, mixed advice and how these influenced parental perception/management of behaviours. ‘Foundations to help-seeking’ highlighted important roles of social support and online help for valued shared experiences, emotional and practical support.

Conclusion

Health professional access and advice are important to parents, despite the increasing role of online help and importance of social support. More support and improved access to reliable sources of information is needed for parents.

Implications for the Profession and/or Patient Care

Findings will inform future research and clinical practice to address parental uncertainties. Qualitative research with front-line health professionals is necessary.

Impact

Findings can inform the development of resources to support professionals/families managing unsettled babies.

Reporting Method

Standards for Reporting Qualitative Research.

Public Involvement

A public contributor was involved throughout all stages of the research. Emerging findings were discussed at a parent group.

What does this paper contribute to the wider global clinical community?

Addressing parental uncertainties is important; about what is normal, non-pharmacological approaches and when pharmacological intervention is required. A digital information/self-management intervention may be useful for parents/clinicians.

Multicentre randomised trial of screening with sFlt1/PlGF and planned delivery to prevent pre-eclampsia at term: protocol of the PE37 study

Por: Llurba · E. · Crispi · F. · Crovetto · F. · Youssef · L. · Delgado · J. L. · Puig · I. · Mora · J. · Krofta · L. · Mackova · K. · Martinez-Varea · A. · Tubau · A. · Ruiz · A. · Paya · A. · Prat · M. · Chantraine · F. · Comas · C. · Kajdy · A. · Lopez-Tinajero · M. F. · Figueras · F. · Gratac
Introduction

Pre-eclampsia affects ~5%–7% of pregnancies. Although improved obstetric care has significantly diminished its associated maternal mortality, it remains a leading cause of maternal morbidity and mortality in the world. Term pre-eclampsia accounts for 70% of all cases and a large proportion of maternal–fetal morbidity related to this condition. Unlike in preterm pre-eclampsia, the prediction and prevention of term pre-eclampsia remain unsolved. Previously proposed approaches are based on combined third-trimester screening and/or prophylactic drugs, but these policies are unlikely to be widely implementable in many world settings. Recent evidence shows that the soluble fms-like tyrosine kinase-1 (s-Flt-1) to placental growth factor (PlGF) ratio measured at 35–37 weeks’ gestation predicts term pre-eclampsia with an 80% detection rate. Likewise, recent studies demonstrate that induction of labour beyond 37 weeks is safe and well accepted by women. We hypothesise that a single-step universal screening for term pre-eclampsia based on sFlt1/PlGF ratio at 35–37 weeks followed by planned delivery beyond 37 weeks reduces the prevalence of term pre-eclampsia without increasing the caesarean section rates or worsening the neonatal outcomes.

Methods and analysis

We propose an open-label randomised clinical trial to evaluate the impact of a screening of term pre-eclampsia with the sFlt-1/PlGF ratio followed by planned delivery in asymptomatic nulliparous women at 35–37 weeks. Women will be assigned 1:1 to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cut-off of >90th centile is used to define the high risk of subsequent pre-eclampsia and offer planned delivery from 37 weeks. The efficacy variables will be analysed and compared between groups primarily following an intention-to-treat approach, by ORs and their 95% CI. This value will be computed using a Generalised Linear Mixed Model for binary response (study group as fixed effect and the centre as intercept random effect).

Ethics and dissemination

The study is conducted under the principles of Good Clinical Practice. This study was accepted by the Clinical Research Ethics Committee of Hospital Clinic Barcelona on 20 November 2020. Subsequent approval by individual ethical committees and competent authorities was granted. The study results will be published in peer-reviewed journals and disseminated at international conferences.

Trial registration number

NCT04766866.

Suicidal thoughts and behaviours among student nurses and midwives: A systematic review

Abstract

Aim

To synthesize research investigating suicide, suicide attempts, self-harm and suicide ideation in nursing and midwifery students, a group of interest due to high rates of suicide among qualified nurses. Specific areas of interest for this review included prevalence, factors which may contribute to or mitigate risk and suicide prevention interventions.

Design

A systematic review was conducted, and Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines were followed.

Data Sources

Three electronic databases were searched, and additional articles identified using hand-searching. Studies were included if they examined suicide, suicide attempts, self-harm or suicide ideation in nursing or midwifery students.

Review Methods

Studies were deduplicated and assessed for inclusion. Data from included studies were extracted, quality of studies assessed and data synthesized, informed by study focus, design and assessed quality.

Results

About 46 studies of largely moderate to low quality were identified. A high-quality study demonstrated increased risk of suicide in Swedish female nursing students, and increased risk of self-harm in nursing students of both sexes. Prevalence of suicide ideation did not appear to differ across course year, or between nursing students and students on other programmes. Psychiatric conditions, particularly depression, were associated with suicide ideation. Three studies related to suicide prevention interventions were identified. Integration of wellness initiatives into the curriculum and peer support were preferred interventions among nursing students and teaching staff.

Conclusions

To understand the extent of suicide and self-harm among nursing and midwifery students there is a need for further epidemiological research stratified by programme of study. To develop prevention interventions and initiatives for nursing students, high-quality longitudinal studies should examine characteristics associated with suicide and self-harm.

Impact

Current findings suggest interventions could include support for students experiencing mental health difficulties, foster peer support, and help develop wellness.

No patient or public contribution.

Effects of a laboratory-based aerobic exercise intervention on brain volume and cardiovascular health markers: protocol for a randomised clinical trial

Por: Molina Hidalgo · C. · Collins · A. M. · Crisafio · M. E. · Grove · G. · Kamarck · T. W. · Kang · C. · Leckie · R. L. · MacDonald · M. · Manuck · S. B. · Marsland · A. L. · Muldoon · M. F. · Rasero · J. · Scudder · M. R. · Velazquez-Diaz · D. · Verstynen · T. · Wan · L. · Gianaros · P. J
Introduction

Physical activity (PA) has beneficial effects on brain health and cardiovascular disease (CVD) risk. Yet, we know little about whether PA-induced changes to physiological mediators of CVD risk influence brain health and whether benefits to brain health may also explain PA-induced improvements to CVD risk. This study combines neurobiological and peripheral physiological methods in the context of a randomised clinical trial to better understand the links between exercise, brain health and CVD risk.

Methods and analysis

In this 12-month trial, 130 healthy individuals between the ages of 26 and 58 will be randomly assigned to either: (1) moderate-intensity aerobic PA for 150 min/week or (2) a health information control group. Cardiovascular, neuroimaging and PA measurements will occur for both groups before and after the intervention. Primary outcomes include changes in (1) brain structural areas (ie, hippocampal volume); (2) systolic blood pressure (SBP) responses to functional MRI cognitive stressor tasks and (3) heart rate variability. The main secondary outcomes include changes in (1) brain activity, resting state connectivity, cortical thickness and cortical volume; (2) daily life SBP stress reactivity; (3) negative and positive affect; (4) baroreflex sensitivity; (5) pulse wave velocity; (6) endothelial function and (7) daily life positive and negative affect. Our results are expected to have both mechanistic and public health implications regarding brain–body interactions in the context of cardiovascular health.

Ethics and dissemination

Ethical approval has been obtained from the University of Pittsburgh Institutional Review Board (IRB ID: 19020218). This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.

Trial registration number

NCT03841669.

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