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Protocol for a scoping review of interventional trials in complex regional pain syndrome: evaluation of adherence to the core outcome set, SPIRIT-PRO and CONSORT-PRO guidelines

Por: Cork · H. · Deutsch · A. · Kyte · R. · Turner · D. · Kyte · D.
Introduction

Complex regional pain syndrome (CRPS) is a debilitating chronic pain condition that severely reduces quality of life. Physiotherapy is a key component of management; however, high-quality evidence to inform optimal practice is limited. Variability in outcome measurement and poor reporting quality may hinder the ability to synthesise findings and inform best practice.

Although international guidelines for reporting patient-reported outcomes (PROs) have been developed to address these issues and a CRPS Core Outcome Set (COS) has been published, the extent to which they have been adopted in CRPS research remains unclear. This protocol describes a scoping review, which aims to explore whether randomised controlled trials evaluating physiotherapy interventions for adults with CRPS adhere to COS recommendations and comply with PRO reporting guidelines.

Methods and analysis

The design of the scoping review will align with the Joanna Briggs Institute methodology. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews will be used to guide reporting. Electronic databases including MEDLINE, CINAHL, Embase, CENTRAL and PsycINFO will be searched in addition to the WHO International Clinical Trials Registry Platform (WHO-ICTRP). Titles, abstracts and full texts will be screened by two independent reviewers. Data extraction and synthesis will follow, with discrepancies resolved through discussion with a third reviewer. Adherence to the CRPS COS will be assessed by mapping trial outcomes to COS domains, and compliance with Standard Protocol Items Recommendations for Interventional Trials: Patient-Reported Outcome Extension (SPIRIT-PRO) and Consolidated Standards of Reporting Trials: PRO Extension (CONSORT-PRO) guidelines will be evaluated against checklist items. Data will be summarised descriptively, with subgroup analysis comparing trials initiated before and after COS publication.

Ethics and dissemination

Ethical approval is not required as the study involves no collection of primary data. Findings will be disseminated via peer-reviewed journals, conference presentations and concise reports prepared for key stakeholders.

Registration

This protocol is registered on Open Science Framework and is available at https://doi.org/10.17605/OSF.IO/BFH82.

Front Cover

Front Cover

The cover image is based on the article by Caring Science as a Mature Solution to Global Healthcare Challenges by Sara Horton-Deutsch et al., https://doi.org/10.1111/jan.70237


The Trust‐Link Relational Transition Model: A Unitary Caring Framework for Youth With HIV Transitioning to Adult Healthcare

ABSTRACT

Aims

To develop a conceptual model integrating Robinson's Theory of Trust and Watson's Caritas Processes to guide trust-building approaches and caring practices that support adolescents and young adults with HIV during the healthcare transition from paediatric to adult care.

Design

This is a discursive, theory synthesis paper that integrates theoretical frameworks and conceptually relevant literature to inform model development. The paper emphasises the importance of trust and caring science in the context of long-term engagement in care.

Methods

An inductive theory-building approach was used to identify key themes related to trust, stigma and the patient-provider relationship. Using Pound and Campbell's guidelines for theory synthesis, we developed a conceptual model reflecting the intersection of trust theory and caring science. The synthesis was further grounded in Robinson's concept of theoretical coalescence, supporting the development of a relational framework to guide future research and practice.

Data Sources

A structured literature review was conducted across PubMed, CINAHL, EBSCOhost and Google Scholar. Peer-reviewed articles published between 1987 and 2022 were included to capture the historical and contemporary perspectives on paediatric HIV care and healthcare transition. A snowballing method was also used to identify additional conceptually relevant sources.

Results

The Trust-Link Relational Transition Model highlights trust as a protective factor during transition for adolescents and young adults with HIV and its close links to medication adherence, care engagement and viral suppression. Fostering trust through caring science practices, such as Watson's 10 Caritas Processes, enhances patient-provider relationships, promotes reciprocal trust and empowers patients while addressing stigma, fear of new providers and loss of familiar teams, while promoting autonomy.

Conclusion

The Trust-Link Model, integrating trust theory and caring science, provides a framework for improving healthcare transition. By emphasising trust-building and caring interventions, this model aims to promote autonomy, support adherence and improve health outcomes for youth with HIV transitioning to adult care.

Exploring staff experiences and perceptions of patient‐perpetrated violence in hospital settings: A qualitative study

Abstract

Aims

To explore hospital staff experiences and perceptions of patient-perpetrated violence.

Design

Descriptive qualitative study.

Methods

Twelve semi-structured interviews (June–August 2022) were held with a diverse sample of hospital nurses, doctors, allied health professionals, security and a non-clinical manager. The framework approach was used to organise and analyse data, using Attribution Theory as a theoretical lens.

Results

Three themes were identified: violence as (un)predictable, violence as (un)preventable and the cumulative toll of violence. In making sense of why patients become violent, participants described different ‘types’ of aggressive patients and variably attributed behaviours to situation, disposition or a combination of both. Regardless of perceived causal factors, staff overwhelmingly appeared to view violence as predictable. Participants also reflected on the wider structural problems underpinning violence, frequently alluding to their sense of relative powerlessness to initiate change. The cumulative toll of violence was a common thread, with staff describing their acquisition of ‘resilience’ and reflecting on its role in their responses to escalating situations.

Conclusions

Many hospital staff are resigned to the inevitability of violence. The concept of staff ‘resilience’ following violence is not unproblematic, having the potential to serve as a guise for acceptance and as an additional variable for which staff are held accountable. When designing strategies, organisations should ensure that accountability for violence reduction is distributed across multiple levels. This study makes a novel contribution by exploring the perspectives of multiple staff groups working across diverse hospital settings, and adds to a sparse literature on this subject in the UK.

Implications for the Profession

Efforts to address violence against healthcare staff need to be power-conscious, ensuring that accountability is distributed across multiple levels.

Reporting Method

This study is reported in line with the Consolidated Criteria for Reporting Qualitative Studies (COREQ).

Patient or Public Contribution

No patient or public contribution.

Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study: protocol for a national randomised pragmatic trial

Por: Sage · L. · Hart · E. · Meyer · N. · Hnilicka · O. · Penkin · A. · Poteat · T. C. · Aguayo-Romero · R. · Comstock · B. A. · STRIVE Publications Committee · Dy · G. W. · Blasdel · Corman · Deutsch · Gallo · Gore · Marsiglio · Sevelius · Solo
Introduction

Transgender and gender-diverse individuals often face significant barriers to accessing gender-affirming care, such as hormones and/or surgery, leading to poorer mental health, lower quality of life, and higher rates of substance use and suicidal ideation. Vaginoplasty, the most commonly sought genital gender-affirming surgery (GGAS), is desired by over half of all trans women but has been performed in only a minority. This is due largely to limited surgeon availability and long wait times. Peer support has been shown to improve health outcomes and reduce stigma in marginalised populations, including trans communities, but has never been studied for efficacy during the perioperative period of GGAS. Building on priorities identified by multi-stakeholder engagement from the Transgender & Non-Binary Surgery Allied Research Collective, the Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study aims to evaluate the efficacy of a centralised peer support and education intervention for patients seeking vaginoplasty, addressing a critical gap in perioperative care.

Methods and analysis

The STRIVE Study is a pragmatic, multi-site randomised controlled trial enrolling trans adults seeking full depth vaginoplasty. Participants are randomised to one of two arms; enhanced usual care, or a facilitated group intervention. The primary outcome is coping self-efficacy at 6 months, with a secondary outcome of surgical readiness. Primary analysis uses an intention-to-treat approach with linear mixed effects modelling, adjusting for selected baseline values and site. The feasibility evaluation data collected via qualitative interviews will be analysed thematically.

Ethics and dissemination

Approvals were granted by the primary site’s Institutional Review Board on 10 May 2024 (STUDY00026957). The trial was registered on 24 May 2024. Results will be published in open access journals and made available to community members in plain language formats.

Trial registration number

NCT06436560.

Post‐Event Strategies for Workplace Violence Affecting Hospital Staff: A Scoping Review

ABSTRACT

Aims

To map the evidence on post-incident strategies for workplace violence in global hospital settings, define current literature gaps and provide direction for future research.

Design

Scoping review guided by Joanna Briggs Institute methodology.

Methods

A narrative synthesis, framed by the Haddon Matrix, categorised post-violence strategies by focus on staff (victims), aggressors (vectors), or the physical/social environment.

Data Sources

Six databases (MEDLINE, Embase, Web of Science, CINAHL, PsycINFO, Health Management Information Consortium) and Google Scholar were searched in January 2024.

Results

Twenty-seven articles were included. Post-violence strategies addressed: (1) staff support through debriefs and psychological, clinical and procedural assistance; (2) behaviour management, individualised plans, alerts and accountability measures for aggressors; and (3) system-level responses via incident investigations, feedback processes and integrated monitoring. These strategies were typically embedded within larger multicomponent workplace violence programmes, with limited disaggregation of their specific effects.

Conclusion

The evidence base for tertiary prevention of workplace violence remains sparse. Most articles in this review equated success with violence reduction, reflecting a traditional (Safety-I) focus on risk mitigation, with limited attention to broader outcomes such as staff perceptions of safety or job-related affect. This underscores the need for a clearer focus on the mechanisms by which such interventions are expected to create change, providing an opportunity to refine theory and practice.

Implications for the Profession and/or Patient Care

The post-violence period offers a key juncture for mitigating incidents' ripple effects. As frontline staff are often the primary ‘recipients’ of interventions, future research and service improvement initiatives should focus more closely on outcomes relevant to staff experiences.

Impact

Incorporating a Safety-II perspective, which emphasises resilience and adaptive performance, could enable hospitals to strengthen ongoing operational capabilities in the aftermath of violence and help to redress the conditions that facilitate its recurrence.

Reporting Method

PRISMA-ScR.

Patient or Public Contribution

None.

Caring Science as a Mature Solution to Global Healthcare Challenges

ABSTRACT

Aim

Healthcare systems face a growing challenge: as technology advances, patients increasingly feel like data points in systems that prioritise efficiency over empathy. This paper addresses the global healthcare crisis of disconnection, arguing that fundamental change requires putting human experience at the centre through Caring Science principles in nursing.

Background

COVID-19 clearly revealed this disconnect. While showcasing scientific advances, it exposed gaps in compassionate care and fair access globally. Nurses struggled to maintain human connection while dealing with resource shortages and isolation protocols, proving that advanced medical treatments alone cannot address the physical, emotional, spiritual, and social factors that influence health.

Source of Evidence

This work draws on peer-reviewed studies, contemporary research, and theories of human caring to demonstrate the global responsibility and urgent need for integrating caring practices into healthcare systems. Collectively, this evidence underscores both the necessity of intervention and the effectiveness of Caring Science as a strategy for transforming organisational practices while highlighting a pressing truth: healthcare systems worldwide must move beyond efficiency alone and intentionally weave caring practices into their structures.

Conclusion

This analysis examines Caring Science through three key areas: Relational, Organisational, and Global. Using Watson's Theory of Human Caring and current research, the paper shows how caring relationships can improve through thoughtful use of innovation. Recent healthcare improvements demonstrate promising results when technology integration enhances both nurse empowerment and patient outcomes within frameworks that prioritise human connection.

Implications for Nursing

Future directions position Caring Science as a mature, evidence-informed framework for addressing healthcare's complex challenges. The paper calls for ‘sacred activism’—a commitment to protecting caring's essential dimensions while embracing beneficial innovation, positioning nursing to lead healthcare transformation through both the art and science of nursing that honours human dignity.

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