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Sex and gender reporting and differences in trials evaluating patient decision aids: a secondary analysis of systematic review with meta-analysis

Por: Stacey · D. · Legare · F. · Lewis · K. B. · Smith · M. · Carley · M. E. · Barry · M. J. · Bennett · C. · Bravo · P. · Steffensen · K. D. · Finderup · J. · Gendler · Y. · Gogovor · A. · Gunderson · J. · Kelly · S. E. · Pacheco-Brousseau · L. · Trenaman · L. · Trevena · L. · Volk · R. J. · G
Objectives

Patient decision aids (PtDAs) are effective interventions to support patient involvement in health decisions and have the potential to impact favourably on health inequities by reducing gender bias in clinical practice. The aim was to explore sex and gender reporting and differences in randomised controlled trials (RCTs) evaluating PtDAs for adults making treatment or screening decisions.

Design

Secondary analysis of the Cochrane review of PtDAs of RCTs that reported sex and/or gender. The original review searched MEDLINE, Embase, PsychINFO and EBSCO from journal inception to March 2022. Two team members independently screened citations, extracted data and assessed risk of bias. For this secondary analysis, we only included primary outcomes from the original review. We assessed appropriate use of terminology for sex (biological attribute) and gender (social construct). When terms were used interchangeably, it was considered inaccurate. Findings were synthesised descriptively, and we used meta-analysis when two or more RCTs were conducted with females/women or males/men using similar outcome measures.

Primary and secondary outcome measures

Informed values-choice congruence and the quality of the decision-making process (eg, knowledge, accurate risk perceptions, feeling informed, clear values, participation in decision making, undecided) and adverse events (eg, decision regret, emotional distress) by sex and gender.

Results

Of 209 RCTs in the original review, 206 reported sex and/or gender, with 35 (17%) using accurate terminology. Of 206 RCTs, 70 were with females/women only, 27 males/men only, 12 analysed by sex/gender and 97 RCTs did not disaggregate findings by sex or gender. Meta-analysis comparing RCTs for females/women to usual care and RCTs for males/men only compared with usual care showed similar mean differences in knowledge scores (10.84 vs 9.38 out of 100; p=0.44). Males/men had significantly higher self-reported participation in decision making compared with females/women (RR 3.16 vs 0.95; p

Conclusions

In PtDA RCTs, sex and gender terms are used interchangeably and 6% analysed outcomes by sex or gender. Meta-analysis of males/men only given PtDAs showed higher self-reported decision making participation in clinical practice compared to usual care versus females/women only compared with usual care. Researchers must improve reporting sex and gender in PtDA RCTs to assess how it influences health inequities.

Advice From Patients to Improve Diabetic Foot Ulcer Management and Amputation Prevention

ABSTRACT

Understanding the patient perspective is crucial for enhancing healthcare delivery and outcomes for chronic conditions like diabetic foot ulcers. This qualitative study examined the perspectives of patients with diabetic foot ulcers to inform clinical strategies for both physicians and current patients to enhance care and prevent lower extremity amputations. Fifteen patients with a history of diabetes and diabetic foot ulcers and/or amputations participated in semi-structured interviews which explored their lived experiences and advice for both physicians and fellow patients to improve diabetic foot ulcer related care. Interview transcriptions were analysed to identify recurring themes. Advice for physicians emphasised increasing patient education, initiating preventive foot care at the time of diabetes diagnosis, providing instructions for managing diabetic ulcers early and demonstrating empathetic bedside manner. Advice for fellow patients focused on adopting healthy lifestyle practices, regular foot self-examinations, consistent blood glucose monitoring, medication adherence and seeking prompt medical attention for new or worsening foot lesions. Participants also stressed the importance of routine check-ups with providers to support prevention and management efforts. This qualitative study highlights the value of incorporating patient perspectives to improve our understanding of diabetic foot ulcer onset, care and outcomes and thereby reduce the risk of lower extremity complications.

Experiences and Impacts of Working in Organisations Undergoing Regulatory Scrutiny: An Integrative Review

ABSTRACT

Aim

To explore the experiences of healthcare staff in organisations undergoing regulatory scrutiny and to identify the professional and organisational impact.

Design

Integrative review.

Data Sources

Medline, CINAHL, Scopus, and Google Scholar.

Review Methods

This review followed Whittemore and Knafl's framework, adhering to PRISMA guidelines. Searches identified peer-reviewed studies from 2010 to 2025 examining healthcare staff under regulatory scrutiny. Studies employing diverse methodologies were included and synthesised using the constant comparison method to identify and refine key themes.

Results

Eight studies were included. Four interrelated themes were identified: (1) workforce wellbeing, autonomy, and professional identity; (2) regulatory culture, organisational adaptation, and quality improvement; (3) communication and relationships; and (4) impact on patient care and contextual variation.

Conclusion

Regulatory scrutiny profoundly shapes healthcare quality and professional culture but can unintentionally undermine workforce adaptability and innovation essential for effective care. These findings highlight the need for nursing-sensitive regulatory approaches that support professional autonomy, reduce burden, and enhance patient-centred care.

Impact

This evidence will inform nursing and midwifery policy and practice globally by providing support to inform nuanced, context-sensitive regulatory approaches that safeguard professional autonomy, reduce administrative burden, and promote safe, person-centred care across diverse healthcare settings. It will assist policymakers, healthcare leaders, and educators worldwide in enhancing workforce sustainability, patient safety, and care quality, facilitating the transfer of learning to varied healthcare environments and systems.

Patient or Public Contribution

Not applicable.

The role of online peer support in pregnancy: A scoping review

by Honor Morris, Maria Duaso, Marilyn Ijeomah-Orji, Lisa Akester, Jenny Roddy, Jayne Samples, Kate Heighway, Nigel Simpson, Tomasina Stacey

Background

Online peer support groups offer virtual spaces where members can share experiences, seek advice, and offer mutual support. While in-person peer support in pregnancy has shown benefits such as improved well-being and reduced isolation, limited research has explored online peer support groups. This scoping review aims to examine the types, contexts, and perceived benefits of online peer support for pregnant people.

Methods

A systematic search was conducted in five databases (Embase, Medline PsychInfo, MIDIRS and CINAHL) from inception to December 2024. Eligible studies examined online peer support accessed by pregnant participants with direct interaction. Thematic analysis was applied to identify structural factors influencing the functioning of online peer support groups. The Langford Conceptual Analysis of Social Support was used to categorise type of support.

Findings

A total of 27 studies were included. The findings highlighted several structural factors that influence the functioning of online peer support groups for pregnant people. Group size was identified as a key factor, with smaller groups promoting more meaningful interactions. Active moderators supported participant interaction and ensured information quality, while privacy settings, such as closed groups and anonymised participation, fostered safe discussions. Emotional support, such as expressions of empathy, reassurance, and encouragement, was the most reported benefit, followed by informational and appraisal support. Instrumental support was observed less frequently.

Conclusion

This scoping review identified key structural factors shaping the design and functioning of online peer support groups for pregnant people. Group size, active moderation, and privacy settings influenced participation and engagement. Further research is recommended to explore how these structural elements impact long-term engagement and overall effectiveness for pregnant people.This project is funded by the National Institute for Health and Care Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number NIHR205347). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

How much is too much? A medication use evaluation of VA ICU sedation practice during the COVID-19 pandemic

by Ian C. Murphy, Kelly Bryan, Muriel Burk, Rong Jiang, Francesca Cunningham, Sarah Providence, Elizabeth Rightnour, Sarah Zavala, Kathleen Morneau, Trisha Exline, Stacey Rice, Travis Schmitt, Kelly Drumright, Jennifer Lee, BreAnna Davids, Tram Guilbeault, Brooke Klenosky, Ann-Marie Sutherland, Abbie Rosen, Lauren Ratliff, Kenneth Bukowski, Margaret A. Pisani, Andrew Franck, Mark Wong, Preston Witcher, Kathleen M. Akgün

OBJECTIVES

Early data suggested higher sedative requirements for ventilated COVID+ patients, deviating from established guidelines. We assessed the relationship between sedative use and outcomes in mechanically ventilated Veterans during the COVID-19 pandemic.

Design

Retrospective Medication Use Evaluation

Setting

National Sample of 13 Distinct VA Medical Center Intensive Care Units

Patients

Critically ill Veteran patients requiring mechanically ventilation for ≥2 days

Interventions

None.

Measurements and main results

The proportion of patients receiving fentanyl, midazolam and propofol was higher during COVID years. Compared with pre-COVID, median fentanyl dose was higher during Years 1 and 2 (1575mcg [(IQR) 1000–1650] vs. 1900 [1250–3000] vs. 1910 [1150–3500]). Adjuvant antipsychotics use was relatively low but tended to increase over time (pre = 10.5% vs. Year 1 = 12.3% vs. Year 2 = 14.1%). Most patients started on antipsychotics in the ICU were continued on the drug after extubation. Mortality was higher during COVID years (pre = 26.9% vs. 1 = 36.8% and 2 = 35.9%). In stratified analyses by COVID status years 1–2 (n = 79, 27%), a higher proportion of COVID+ patients received fentanyl (96% vs. 84%) and propofol (90% vs. 77%) and at higher doses (fentanyl = 1650mcg vs. 2688mcg median cumulative dose; propofol maximum infusion rate = 30 mc/kg/min (20–50) vs. 40 (25–50)). Sedative doses were similar to pre-COVID among non-COVID patients. Anti-psychotics were more frequently continued post extubation among COVID+ (34.6% vs. non-COVID+=14.9%). COVID+ patients were also less likely to have awakening and breathing trials at 48 hours after intubation (18% vs. 46%).

Conclusions

Sedative use and dosing increased during the first two years of COVID compared to pre-COVID, especially for COVID+ patients. The sustained elevated levels of fentanyl use in Year 2 suggests possible ‘therapeutic creep’ away from guideline-concordant practices for COVID+ patients. Antipsychotic prescription during intubation and following extubation was also more common among COVID + . These findings could inform development and implementation of safer sedation practices across VA ICUs during respiratory pandemics.

Trends in incident acute rheumatic fever or rheumatic heart disease in Indigenous youth in Western Australia: a retrospective cohort study

Por: MacDonald · B. · Sodhi-Berry · N. · Stacey · I. · Robinson · M. · Carapetis · J. · Bowen · A. C. · Budgeon · C. · Nedkoff · L. · Katzenellenbogen · J. M.
Objective

To determine age-specific and age-standardised incidence trends of acute rheumatic fever (ARF) or rheumatic heart disease (RHD) among Indigenous Western Australians aged less than 35 years of age.

Design

A population-based retrospective cohort study with linked data analysis.

Setting

Western Australian hospital admissions (1996–2022) and RHD notifications to the state-based register (2011–2015).

Participants

Patients, both Indigenous and non-Indigenous aged

Results

Of 1746 incident ARF/RHD cases, 1526 (87%) were Indigenous peoples, with the highest rates observed in patients aged 5–14 years, with an annual estimated increase of 4.3% (95% CI 3.2% to 5.2%). The 0–4 years age group experienced an annual increase in incidence rates of 4.8% (95% CI 1.4% to 8.2%). Overall, Indigenous patients experienced an annual increase of 1.9% (95% CI 1.3% to 2.6%) from 1996 to 2022. However, most cases (n=894) were identified after multiple significant policy developments (2011–2022) with an annual increase of 5.7% (95% CI 3.7% to 7.5%) for this period.

Conclusion

Increasing trends of incident ARF/RHD were observed in Indigenous patients aged under 15 years, with the greatest annual increments observed after policy implementation for disease reporting and awareness in the period from 2011 to 2022. Improvement in case ascertainment of ARF/RHD may be contributing towards increasing trends with improved reporting and monitoring of incident cases in very young Indigenous Australians more recently.

Recruitment, retention and reporting of ethnic representativeness in maternity trials: a scoping review

Por: Lovell · H. · Wicks · E. · Thompson · H. · Brace · L. · Stacey · T. · Rayment-Jones · H. · Harding · S.
Introduction

Black and Asian women experience significantly higher rates of mortality and morbidity perinatally compared with white women and are more likely to lose their babies. These groups are also under-represented in clinical research, resulting in evidence that may not be generalisable. Tools have been developed to facilitate the inclusion of ethnic minority groups, but it is unknown to what extent representation and inclusion are considered in maternity trials.

Aim

To provide an overview of how ethnically diverse recruitment is considered and reported in maternity trials in the UK.

Methods

A scoping review was conducted, undertaking a systematic search to identify published trial protocols and their subsequent results papers, conducted within the UK, recruiting women during pregnancy or within 6 weeks postnatally between 2004 and 2024.

Data was extracted from protocols on whether representation of participants was considered in the study design and if specific recruitment and retention strategies were planned for ethnic minority groups.

Data extracted from results papers identified whether representation of participants was discussed and if recruitment strategies were discussed; these were compared against the protocol.

Results

A total of 96 published protocols met the inclusion criteria; 8 mentioned specific recruitment strategies and 5 mentioned specific retention strategies. Only two included both recruitment and retention strategies. The most common strategies included providing different types of language support and adapting interventions to be culturally appropriate. Strategies were not evaluated.

67 results papers were available. Ethnicity was reported in 57 papers, with heterogeneity of categories between papers. Only 32 papers discussed representativeness of participants.

Conclusion

Few maternity trials report considerations on how they ensure they are recruiting and retaining ethnically representative participants. Minimal discussion is undertaken around the extent to which trial participants reflect the population to which findings will be applied.

Further work is needed to support implementation and evaluation of inclusive research guidance. Failing to ensure those from ethnic minority groups are included in research can exacerbate inequalities.

Timely Implementation of Patient‐Reported Outcomes in Clinical Care: Insights From Clinicians and Health Informatics Experts

ABSTRACT

Aim

To explore the optimal timing of patient-reported outcome assessment, defined as the collection and use of patient-reported outcomes at clinically meaningful points such as before or during encounters, treatment initiation and follow-up, and to identify the facilitators and barriers to timely use.

Design

A qualitative analysis of semi-structured interviews with healthcare professionals across diverse US health systems.

Methods

Thematic analysis was used to identify key themes related to the timing and implementation of patient-reported outcomes assessments. Interviews were analysed iteratively to develop a coding framework and synthesise overarching themes.

Results

Fourteen healthcare professionals, including nurse practitioners, cardiologists and health informatics experts across seven U.S. health systems from academic and community hospitals, were interviewed in February 2024. Three major themes emerged: (1) value proposition of timely patient-reported outcome data collection (2) key facilitators for timely implementation and (3) multilevel barriers. The value proposition focused on the use of patient-reported outcomes for prevention and active disease management. Critical facilitators for the timely implementation of patient-reported outcomes included the involvement of research and clinical coordinators, strategies for pre-visit and on-site patient-reported outcome collection, the use of standardised templates within EHRs and the alignment of patient-reported outcome collection with patients' long-term treatment goals. Finally, multilevel barriers included time constraints, patient-level challenges (e.g., fatigue, literacy, language) and systemic issues (e.g., technical limitations, lack of reimbursement and unclear guidelines).

Conclusion

Timely collection and use of patient-reported outcomes is critical for improving symptom monitoring and supporting patient-centered clinical decision-making. However, multilevel barriers hinder consistent implementation across health care settings.

Implications for the Profession and/or Patient Care

Integrating patient-reported outcomes into clinical workflows can improve the patient-centeredness of patient-healthcare professional interactions, and provide a more holistic picture of a patient's health status. Addressing barriers to patient-reported outcome implementation, including lack of time, poor health literacy and workflow integration barriers, is crucial for improving clinical outcomes.

Reporting Method

This study adhered to the COREQ (Consolidated Criteria for Reporting Qualitative Research) checklist, in accordance with EQUATOR Network guidelines.

Patient or Public Contribution

No patient or public involvement: This study did not include patient or public involvement in its design, conduct or reporting.

Parents’ Experiences of Holding Their Child for Healthcare Procedures: A Qualitative Exploratory Study

ABSTRACT

Aim

To explore parents' experiences of holding children for healthcare procedures in an Australian paediatric hospital setting.

Design

A qualitative exploratory study was undertaken at a paediatric tertiary hospital in Melbourne, Australia.

Methods

Semi-structured interviews were conducted with parents of children who had undergone a procedure during their hospital admission. Interviews were audio recorded, transcribed and analysed using reflexive thematic analysis.

Results

Eight parents were interviewed, with four themes becoming apparent from their experiences, representing the multiple roles parents undertook when holding their child for a procedure. Parent as a protector was identified as the overarching role, with all roles involving aspects of parents protecting their child. The remaining roles included comforter—where parents supported their child by providing reassurance and being present; helper—where parents actively sought a role or stepped up to assist during a procedure and enforcer—where at times parents had a belief that to facilitate some procedures holding was necessary. A sliding-scale schema illustrates that these roles are not static, but rather positioned along a continuum, with some parents moving between roles throughout a procedure.

Conclusion

This study provided valuable insight into the complexity of parents' involvement when supporting their child during a procedure. The varying roles suggest parents balance the desire for their child to feel safe (holding as a comforter) with wanting to get the procedure done (holding as an enforcer).

Impact

This research impacts clinicians, parents and children involved in healthcare procedures. Clinicians can use the sliding-scale schema that illustrates the distinct roles parents can take on, as a visual tool to promote parental involvement and help parents define their role during a procedure.

Reporting Method

Consolidated Criteria for Reporting Qualitative Research (COREQ) guideline was utilised when reporting findings.

Patient or Public Contribution

No patient or public contribution.

The impact of the COVID‐19 pandemic on longitudinal trends of surgical mortality and inpatient quality of care in Ontario, Canada

Abstract

Aims

Previous studies have shown the COVID-19 pandemic was associated with reductions in volume across a spectrum of non-SARS-CoV-2 hospitalizations. In the present study, we examine the impact of the pandemic on patient safety and quality of care.

Design

This is a retrospective population-based study of discharge abstracts.

Methods

We applied a set of nationally validated indicators for measuring the quality of inpatient care to hospitalizations in Ontario, Canada between January 2010 and December 2022. We measured 90-day mortality after selected types of higher risk admissions (such as cancer surgery and cardiovascular emergency) and the rate of patient harm events (such as delirium, pressure injuries and hospital-acquired infections) occurring during the hospital stay.

Results

A total 13,876,377 hospitalization episodes were captured. Compared with the pre-pandemic period, and independent of SARS-CoV-2 infection, the pandemic period was associated with higher rates of mortality after bladder cancer resection (adjusted risk ratio [aRR] 1.20 (1.07–1.34)) and open repair for abdominal aortic aneurysm (aRR 1.45 (1.06–1.99)). The pandemic was also associated with higher rates of delirium (adjusted odds ratio [aOR] 1.04 (1.02–1.06)), venous thromboembolism (aOR 1.10 (1.06–1.13)), pressure injuries (aOR 1.28 (1.24–1.33)), aspiration pneumonitis (aOR 1.15 (1.12–1.18)), urinary tract infections (aOR 1.02 (1.01–1.04)), Clostridiodes difficile infection (aOR 1.05 (1.02–1.09)), pneumothorax (aOR 1.08 (1.03–1.13)), and use of restraints (aOR 1.12 (1.10–1.14)), but was associated with lower rates of viral gastroenteritis (aOR 0.22 (0.18–0.28)). During the pandemic, SARS-CoV-2-positive admissions were associated with a higher likelihood of various harm events.

Conclusion

The COVID-19 pandemic was associated with higher rates of patient harm for a wide range of non-SARS-CoV-2 inpatient populations.

Impact

Understanding which quality measures are improving or deteriorating can help health systems prioritize quality improvement initiatives.

Patient or Public Contribution

No patient or public contribution.

Acceptability of dietary or nutritional supplementation in pregnancy (ADONS) – Exploring the consumer's perspective on introducing creatine monohydrate as a pregnancy supplement

Pre-clinical studies suggest maternal dietary creatine supplementation during pregnancy could protect babies against hypoxic intrapartum events, however creatine has not been used as a supplement in pregnancy. The aim of this study was to explore pregnant women and healthcare professional's general knowledge, behaviours, and attitudes toward nutritional supplements, and their thoughts on introducing creatine as a pregnancy supplement.
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