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Evaluating pain and neurological function with high frequency 10 kHz spinal cord stimulation in the treatment of painful diabetic neuropathy: design of a multicentre, randomised controlled trial (PDN-Sensory)

Por: Pop-Busui · R. · Petersen · E. A. · Levy · B. L. · Tesfaye · S. · Armstrong · D. G. · Grunberger · G. · Boulton · A. J. · Bharara · M. · Edgar · D. · Azalde · R. P. · Caraway · D.
Introduction

Current pharmacological treatment options for painful diabetic neuropathy (PDN) often fail to provide adequate pain relief. However, in the recent SENZA-PDN study, high-frequency 10 kHz spinal cord stimulation (SCS) demonstrated significant long-term improvements in lower limb pain and health-related quality of life (HRQoL) in a PDN population. Furthermore, more than half of 10 kHz SCS recipients showed improved sensory function based on non-blinded clinical assessments in post hoc analysis. We report the design of the PDN-Sensory study, which aims to evaluate changes in pain and neurological function with 10 kHz SCS in the treatment of PDN. The study will include objective measures of neurological function, including the modified Toronto Clinical Neuropathy Score (mTCNS) and intraepidermal nerve fibre density (IENFD).

Methods and analysis

This multicentre, prospective, randomised controlled trial will compare conventional medical management (CMM) with 10 kHz SCS+CMM in individuals with diabetes and chronic, intractable lower limb pain due to PDN. Participants will be randomised 1:1 to CMM alone or 10 kHz SCS+CMM, with optional crossover at 6 months. The primary outcome is the proportion of participants at 6 months achieving ≥50% pain relief from baseline. The key secondary endpoint is the proportion of participants at 6 months with a reduction in mTCNS of ≥3 points from baseline (excluding changes in foot pain). Additional endpoints at 6 and 12 months include changes from baseline in mTCNS, IENFD, 7-day averaged pain score, pain-related interference, HRQoL, sleep, psychological outcomes, functional status and metabolic parameters.

Ethics and dissemination

The study protocol received central approval from the Western Institutional Review Board (IRB #20230954). Local IRB approval will be required before initiation of the study at each participating clinical site. The study complies with Good Clinical Practice guidelines (ISO 14155), the Declaration of Helsinki, and all applicable national, federal and local regulatory requirements. Dissemination plans include presentations at national and international conferences and publication in a peer-reviewed journal with open access.

Trial registration number

NCT05777317.

A Systematic Review of Instruments to Measure Nurses' Well‐Being in the Work Environment

ABSTRACT

Aims

To identify instruments for measuring nurses' well-being at work, evaluate their dimensions, validity, reliability, and determine the most comprehensive of all.

Design

Systematic literature review of measurement properties.

Data Sources

Science Direct, PubMed, ProQuest, EBSCO, Scopus, Sage, and Google Scholar for all periods.

Review Methods

Quantitative research articles that provide information on psychometric testing of instruments for measuring nurses' well-being were analyzed, excluding non-scientific, and non-English sources. The Consensus-based Standards for The Selection of Health Measurement Instrument (COSMIN) was used to identify the risk of bias. Terwee quality criteria were used to assess the quality of the measurement properties. The synthesis process was performed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). This study was registered in PROSPERO (CRD42024532860).

Results

A total of 22 articles, covering 17 instruments developed based on different theories and concepts were identified. The number of items ranges from 5–69, with 1–8 dimensions, where the interpersonal relationship is the most widely used dimension. Only a few instruments assess nurses' well-being in particular units. Validity and reliability were tested through various methods, but none met all COSMIN criteria. GRADE analysis revealed that over half of the instruments had low-quality assessment results.

Conclusion

Instruments varied in structure, including the number of items, scales, and dimensions. The low-quality assessment results of most instruments highlight the need for better instrument development and validation, especially for nurses in specific units by considering their respective work culture and climate.

Impact

This study emphasizes the need to develop an instrument to measure nurses' well-being in certain units specifically according to the COSMIN guidelines to improve its validity and reliability. The results of such measurements can help management formulate effective intervention strategies and serve as a basis for further research.

Patient or Public Contribution

No patient or public contribution.

Exploring the Unique Challenges of ICU‐To‐Ward Transitions for Patients and Families: A Meta‐Synthesis of Qualitative Research

ABSTRACT

Background

The transition from the intensive care unit to the general ward is complex. Understanding patients' and families' experiences during this period is essential for optimising nursing care.

Aim

Explore the experiences of patients and families during the transition from the intensive care unit to the general ward.

Design

A qualitative meta-synthesis integrated and interpreted studies on intensive care unit patients' and families' experiences during transitions to general wards, involving systematic searches, appraisal, and integration analysis.

Data Sources

PubMed, Web of Science, Embase, EBSCO, CNKI, Wanfang, and VIP databases were searched using subject and free-text strategies, covering inception to July 2024.

Review Methods

Inclusion criteria included qualitative studies in English and Chinese that fit the study topic. Two researchers independently reviewed 42 full-text articles, of which 26 met the criteria. Quality appraisal used the JBI qualitative research assessment tool, and data were synthesised by the pooled integration method.

Results

Three key themes emerged from the analysis: (1) emotional duality of hope and anxiety before transfer, (2) heightened vulnerability and disorientation during ICU-to-ward transition, and (3) unmet needs. These themes were further divided into nine subcategories.

Conclusions

Transitions from intensive care units to general wards present patients and families with mixed emotions and challenges in adaptation. Continuity of care, family engagement, and tailored health education are vital to supporting patient recovery and family well-being.

Impact

Assessing patient and family anxiety during ICU transitions and using evidence-based interventions to manage emotions can improve recovery and reduce complications. The healthcare team should prioritise early intensive care unit rehabilitation to prevent functional decline, particularly in lower-intensity ward care. Identify patient and family needs when designing transition interventions. Use personalised, targeted health education tailored to different patient and family characteristics to enhance effectiveness across varied healthcare settings.

No Patient or Public Contribution

This is a meta- synthesis without direct patient involvement.

The Mediating Effect of Team Job Crafting on the Association Between Transformational Leadership and Occupational Well‐Being in Newly Graduated Nurses

ABSTRACT

Objective

To explore the mediating effect of team job crafting on the transformational leadership–occupational well-being association in newly graduated nurses.

Methods

A multicentre cross-sectional study was conducted in three tertiary hospitals in China. Using convenience sampling, 677 newly graduated nurses were recruited between August 2024 and September 2024, and completed the transformational leadership questionnaire, team job crafting scale for nurses, and healthcare providers' occupational well-being scale. Data analysis was performed using IBM SPSS 27.0 software and the PROCESS 4.2 plugin. Hayes' mediation model (Model 4) was employed to test the indirect effect. The significance of the mediating effect was assessed using the bias-corrected bootstrap method (5000 resamples).

Results

Ultimately, 546 valid questionnaires were collected. The participants' transformational leadership, nurse team job crafting and healthcare providers' occupational well-being scores were all above average. Linear regression analysis revealed that transformational leadership and team job crafting positively predicted occupational well-being (β = 0.549, p < 0.001; β = 0.695, p < 0.001). Mediating analysis revealed that the indirect effect of transformational leadership on occupational well-being was 0.276 (95% confidence interval: 0.174, 0.377), indicating the presence of an indirect effect. Additionally, team job crafting accounted for 33.5% of the effect of transformational leadership on occupational well-being.

Conclusion

Perceived transformational leadership among newly graduated nurses could positively influence their occupational well-being, with team job crafting playing a partial mediating role between the two. Therefore, it is recommended that nursing managers strengthen their transformational leadership practices to promote the accumulation and internalisation of job resources among newly graduated nurses, thereby enhancing their ability and level of team job crafting and further promoting their occupational well-being.

“Sandwiched Individuals” Exploring the Push and Pull Factors Influencing Retention Among Mid‐Career Nurses: An Integrative Review

ABSTRACT

Aim

To systematically analyse international empirical literature and establish a comprehensive understanding of the push and pull factors influencing retention and turnover among mid-career nurses.

Design

An integrative review.

Data Sources

PubMed, Web of Science, Scopus, EMBASE (Ovid), and CINAHL (EBSCO) were searched for studies published between January 2001 and November 2024.

Methods

An integrative literature review was conducted following the five-step process outlined by Whittemore and Knafl. Articles were screened by title, abstract, and full text based on predefined inclusion and exclusion criteria. The quality of eligible studies was assessed using the Mixed Methods Appraisal Tool (MMAT). Data were extracted and synthesised narratively, and the findings were presented according to the socio-ecological framework.

Results

A total of 1930 studies were identified, with 14 included for analysis: 10 qualitative, 3 quantitative, and 1 mixed-methods study. Guided by the socio-ecological framework, four themes and 10 subthemes emerged: (1) Intrapersonal (professional knowledge/skills, health issues, work-family balance); (2) Interpersonal (professional collaborative relationships, supervisor support); (3) Organisational (organisational characteristics, work characteristics, career development); and (4) Societal (salary/benefits, Social/governmental recognition).

Conclusion

This review reveals the heterogeneity of research on this topic and confirms previous findings. It identifies certain push-and-pull factors common to nurses across all stages of their careers. However, mid-career nurses face unique challenges, including more complex healthcare demands, declining health status, growing family caregiving responsibilities, unclear organisational roles, underutilisation of professional skills, career stagnation, and limitations on salary growth. These findings highlight the need for tailored retention strategies for mid-career nurses.

Implications for the Profession

A “one-size-fits-all” retention strategy does not meet the needs of all nurses. To improve nurse retention rates, it is essential to address the shifting demands and priorities that arise as nurses reassess and transition through different career stages. For mid-career nurses, acknowledging and valuing their expertise and capabilities, providing sufficient resources, and fostering a supportive work environment that promotes career development may be effective strategies for retaining these experienced professionals.

Reporting Method

Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

Patient or Public Contribution

No Patient or Public Contribution.

Neurological outcomes with hypothermia versus normothermia in patients with moderate initial illness severity following resuscitation from out-of-hospital cardiac arrest: protocol for a multicentre randomised controlled trial (R-CAST OHCA)

Por: Naito · H. · Nishikimi · M. · Okada · Y. · Maeyama · H. · Kiguchi · T. · Yorifuji · T. · Nishida · K. · Matsui · S. · Kuroda · Y. · Nishiyama · K. · Iwami · T. · Nakao · A. · JAAM R-CAST OHCA Trial Group · Nishikimi · Otani · Ryosuke · Yumoto · Hayakawa · Sakurai · Fukushima · Tanaka
Introduction

Temperature control is a fundamental intervention for neuroprotection following resuscitation from cardiac arrest. However, evidence regarding the efficacy of hypothermia in post-cardiac arrest syndrome (PCAS) remains unclear. Retrospective studies suggest that the clinical effectiveness of hypothermia may depend on the severity of PCAS. The R-CAST OHCA trial aims to compare the efficacy of hypothermia versus normothermia in improving 30-day neurological outcomes in patients with moderately severe PCAS following out-of-hospital cardiac arrest.

Methods and analysis

The multicentre, single-blind, parallel-group, superiority, randomised controlled trial (RCT) is conducted with the participation of 35 emergency and critical care centres and/or intensive care units at academic and non-academic hospitals. The study enrols moderately severe PCAS patients, defined as those with a revised post-Cardiac Arrest Syndrome for induced Therapeutic Hypothermia score of 5.5–15.5. A target number of 380 participants will be enrolled. Participants are randomised to undergo either hypothermia or normothermia within 3 hours after return of spontaneous circulation. Patients in the hypothermia group are cooled and maintained at 34°C until 28 hours post-randomisation, followed by rewarming to 37°C at a rate of 0.25°C/hour. Patients in the normothermia group are maintained at normothermia (36.5°C–37.7°C). Total periods of intervention, including the cooling, maintenance and rewarming phases, will occur 40 hours after randomisation. Other treatments for PCAS can be determined by the treating physicians. The primary outcome is a favourable neurological outcome, defined as Cerebral Performance Category 1 or 2 at 30 days after randomisation and compared using an intention-to-treat analysis.

Ethics and dissemination

This study has been approved by the Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee (approval number: R2201-001). Written informed consent is obtained from all participants or their authorised surrogates. Results will be disseminated via publications and presentations.

Trial registration number

jRCT1062220035.

Impact of Nurses' Knowledge, Self‐Efficacy and Clinical Reasoning Competency on Difficulties in Caring for Patients With Delirium in the Intensive Care Unit: A Cross‐Sectional Study

ABSTRACT

Aim

To examine the impact of critical care nurses' delirium knowledge, self-efficacy and clinical reasoning competency on delirium care difficulties based on the information–motivation–behavioural (IMB) skills model from a behavioural perspective.

Design

Cross-sectional study.

Methods

A total of 440 critical care nurses from five hospitals in China were selected using convenience sampling and invited to complete an online questionnaire for measurement. Data were collected in November 2024 and analysed using SPSS/AMOS with descriptive statistics, Pearson's correlation coefficient and multiple regression. Structural equation modelling was constructed to test the hypothesised relationships among the variables, with bootstrapping to assess mediation effects.

Results

The level of delirium care difficulties was moderated. Delirium care difficulties were negatively correlated with delirium knowledge, self-efficacy and clinical reasoning competency. Clinical reasoning competency partly mediated delirium knowledge and self-efficacy with regard to delirium care difficulties.

Conclusion

Delirium knowledge, self-efficacy and clinical reasoning competency are essential for improving critical care nurses' delirium care competencies. The role of clinical reasoning competency in the relationship between the other two variables and delirium care difficulties was highlighted. Establishing multifaceted innovative delirium education programmes, emphasising individuals' sense of competence and enhancing clinical reasoning competency as behavioural skills were supported. Exploring these pathways using a nurse behaviour change-based perspective is critical.

Implications for the Profession and/or Patient Care

Critical care managers should value nurses' delirium care competencies. Enhancing continuing professional development through system-level support with high reliability and multiform professional education, including innovative theoretical and practical training; advancing policies that increase work motivation and self-planning to stimulate self-efficacy; and exercising critical and reflective thinking to improve clinical reasoning competency may enhance nurses' delirium recognition and care competencies, including prioritisation, potentially improving delirium care dilemmas and patient outcomes.

Reporting Method

The STROBE checklist was used as a guideline.

Patient or Public Contribution

Nurses completed questionnaires.

Trial Registration: Chinese Clinical Trial Registry (ChiCTR2400092177). https://www.chictr.org.cn/bin/project/edit?pid=249216

Systematic review protocol for effectiveness and cost-effectiveness of non-surgical interventions to prevent diabetes progression in adults with prediabetes

Por: Sui · C. F. · Ming · L. C. · Soh · Y. C. · Ng · C. H. · Al-Worafi · Y. M. · Hussain · Z.
Introduction

Prediabetes (PD), defined by impaired glucose tolerance or impaired fasting glucose, represents a growing global health challenge, with a prevalence projected to increase substantially. PD is a critical intervention target because of its high annual progression rate (5–10%) to type 2 diabetes mellitus (T2DM) and elevated cardiovascular disease (CVD) risk. Non-surgical interventions (NSIs), particularly lifestyle modifications (LMs) and pharmacological therapies, are the cornerstone of PD management, demonstrating efficacy and cost efficiency over surgical options. However, despite LM’s ability to reduce T2DM incidence by 40–70% in trials such as the Diabetes Prevention Program, real-world implementation faces barriers, including resource intensity and complex delivery requirements, which increase upfront costs. We aim to review scientific literature reporting on the effectiveness and cost-effectiveness of NSIs for preventing the progression of PD to T2DM among adults.

Methods and analysis

A comprehensive systematic search will be conducted across major biomedical databases (PubMed, Scopus, Cochrane Library, Web of Science) for records published up to July 2024. We will include studies involving adults diagnosed with PD according to the American Diabetes Association (ADA) or WHO criteria, focusing on LM and pharmacological treatments. Observational and interventional study designs, including economic evaluations, will be considered. Primary outcome: diabetes incidence (ADA or WHO glycaemic criteria). Secondary outcomes: (1) CVD risk factors, (2) health utilities and (3) healthcare cost analyses. The protocol adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 guidelines and is registered with PROSPERO (CRD42024561294). Data extraction and quality assessment will be performed by two reviewers, with discrepancies resolved by the consensus of a third reviewer. Data will be narratively synthesised; if the data allow, a meta-analysis will be conducted.

Ethics and dissemination

This systematic review was exempt from ethical approval as it involved no collection of individual patient data and posed no confidentiality risks. The findings will be shared via publication in a peer-reviewed journal or presentation at relevant conferences.

PROSPERO registration number

CRD42024561294.

Analgesia and sedative effects of a fixed nitrous oxide/oxygen mixture on supragingival scaling patients: a study protocol for a randomised controlled trial

Por: Sun · C. · Sui · X. · Zhou · L. · Jiang · X. · Wang · W. · Qiu · X. · Sun · F. · Wang · Y. · Tang · L.
Introduction

Pain during supragingival scaling is often uncomfortable for patients, causing varying degrees of fear and anxiety, thus affecting patient comfort and compliance during treatment and reducing the effectiveness of treatment. Nitrous oxide/oxygen mixtures have the advantages of analgesic and sedative effects and are well tolerated. The purpose of this study is to explore the safety and effectiveness of a fixed inhaled nitrous oxide/oxygen mixture analgesia technology in the process of supragingival scaling and to provide empirical evidence for patients to reduce pain and reduce anxiety during supragingival scaling.

Methods and analysis

This is a randomised, double-blind, placebo-controlled trial that is expected to enrol 120 patients. We will recruit patients undergoing supragingival scaling procedures. Participants will be allocated randomly to either the intervention group (A) or the control group (B) in a 1:1 ratio. Dental hygienists, dental assistants, patients and the collector of the data will all blind themselves to the study. Nurses who carry out the intervention will give doctors envelopes containing the patient’s identification code and the group to which they have been assigned (Group A or Group B). Group A will be given the standard treatment plus a premixed combination of nitrous oxide and oxygen, while Group B will receive oxygen alone in the standard treatment without any sedative analgesics, all under uniform conditions. Evaluations will take place prior to treatment (T0), at 5 min into the intervention (T1), at 15 min during the intervention (T2) and 5 min following the treatment (T3). The primary outcomes will be pain scores and anxiety scores, which will be assessed using the Numeric Rating Scale and the Visual Analogue Scale for Anxiety. Secondary outcome indicators in this study will include patients’ vital signs, side effects and physician and patient satisfaction.

Ethics and dissemination

This study was approved by the Medical Ethics Committee of the 960th Logistics Support Force of the People’s Liberation Army. Written informed consent form will be obtained from each participant. Results will be submitted for publication in peer-reviewed journals.

Trial registration number

ChiCTR2400090261.

Protocol version

Protocol version 1.1.

Development of an evidence‐based nursing practice program for preventing unplanned endotracheal extubations in the intensive care unit: A Delphi method study

Abstract

Aims

This study aims to develop an evidence-based nursing practice program to prevent unplanned endotracheal extubation (UEE) among adult patients in the intensive care unit (ICU).

Design

This study uses the Delphi method to develop an evidence-based nursing practice program.

Methods

A comprehensive review of 18 databases and evidence-based websites was conducted to gather, assess and synthesize evidence on preventing UEEs in adult patients. Using this synthesized evidence, a questionnaire was formulated for further investigation. Subsequently, input was solicited from experts through Delphi surveys to establish an evidence-based nursing practice protocol for preventing UEEs in adult ICU patients. Consistency in consultation results guided subsequent rounds of consultation.

Results

The developed program comprised 43 evidence items categorized into nine dimensions, including risk assessment for unplanned extubation, sedation, analgesia, delirium, balloon management, psychosocial care, early extubation, catheter immobilization and protective restraints. Two rounds of expert inquiry yielded recovery rates of 94.7% and 100% for the first and second questionnaires, respectively. Kendall W values ranged from .224 to .353 (p < .001).

Conclusion

This study developed an evidence-based nursing practice program to prevent UEE in adult ICU patients, employing evidence-based practices and Delphi expert consultation methods. However, further validation of the program's effectiveness is warranted.

Reporting Method

Findings were reported according to the Standards for Reporting Qualitative Research checklist.

Patient or Public Contribution

Nurses contributed to the study by participating in investigations.

Implications for the Profession and Patient Care

The program developed in this study offers an evidence-based framework for preventing unplanned extubation in hospitals, thereby reducing its incidence and enhancing the quality of nursing care.

A qualitative exploration of the use of telehealth for opioid treatment: Implications for nurse‐managed care

Abstract

Aim

To characterise experiences with telehealth for Medications for Opioid Use Disorder (MOUD) services among patients, prescribers, nurses and substance use counsellors to inform future best practices.

Design

We engaged a qualitative descriptive study design.

Methods

Semi-structured interviews were conducted with prescribers (nurse practitioners and physicians, n = 20), nurses and substance use counsellors (n = 7), and patients (n = 20) between June and September 2021. Interviews were verbatim transcribed. Thematic analysis was conducted using a qualitative descriptive method.

Results

Among both providers and patients, four themes were identified: (1) Difficulties with telehealth connection (2) Flexibility in follow-up and retention, (3) Policy changes that enabled expanded care, (4) Path forward with telehealth. Two additional findings emerged from provider interviews: (1) Expansion of nurse-managed office-based opioid treatment, and (2) Novel methods to engage patients.

Conclusions

Patients and providers continued to view telehealth as an acceptable means for delivery and management of MOUD, particularly when utilised in a hybrid manner between in-person visits. Nurse-managed care for this service was evident as nurses extended the breadth of services offered and utilised novel methods such as text messages and management of ‘call-in’ lines to engage patients.

Implications for the profession and/or patient care

Use of telehealth for MOUD should be incorporated into practice settings to reach patients in a flexible manner. Nurses in particular can use this medium to extend office-based opioid treatment by conducting assessments and expanding capacity for other wrap-around services.

Impact

We identify recommendations for best practices in the use of telehealth for opioid use disorder management and highlight the value of nurse-managed care.

Reporting method

The consolidated criteria for reporting qualitative research.

Patient or Public Contribution

Patients with opioid use disorder and prescribers with experience using telehealth were interviewed for this study.

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