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☐ ☆ ✇ BMJ Open

Rationale and design of the AlloFIST trial: a phase I/IIa study to evaluate dose escalation of allogeneic adipose-derived stroma/stem cells for the treatment of Crohns fistula

Por: Buscail · E. · Gilletta de Saint Joseph · C. · Lebrin · M. · Frument · I. · Gross · F. · Bournet · B. · Buscail · L. · Culetto · A. · Mokrane · F. · Delchier · M. C. · Quelven · I. · Daguzan · C. · Pugnet · G. · Duffas · J. P. · Ghouti · L. · Philis · A. · Carrere · N. · Lepage · B. · Le C — Diciembre 30th 2025 at 05:33
Introduction

Crohn’s disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract distinguished by progressive bowel damage with a risk of structuring and penetrating complications. It is characterised by focal or segmental transmural inflammation that disrupts intestinal mucosal integrity and favours the development of abscesses and fistulas. Perianal fistula develops in 13%–39% of patients with CD. Their care is difficult but improves with medical and surgical treatment to preserve anal continence and avoid a maximum proctectomy. Combined treatment with seton placement and concomitant anti-TNF (infliximab, adalimumab) allows wound healing in 40%–70% of cases. The currently available treatments are not curative and fail to provide a long-term resolution. The injection of adipose stromal cells is currently being evaluated in clinical studies for repair-damaged tissues in various diseases (limb ischaemia, osteoarthritis, systemic sclerosis, etc). Immunoregulatory and anti-inflammatory properties of AdMSC (adipose-derived stroma/stem cells) are responsible for accelerating healing and represent an innovative approach for treating perianal fistulas associated with CD.

Methods and analysis

This phase I/IIa study is designed to assess the treatment of complex perianal fistulas linked with CD after failure of conventional treatment by injection of AdMSC (CellReady) into the fistula. Two doses of associated AdMSC will be tested for a dose escalation (5x107 and 10x107 cells) and injected into the wall of the fistula. Those eligible for inclusion include patients with controlled luminal CD characterised by a Harvey-Bradshaw score below or equal to eight and diagnosed on clinical, endoscopic, histological and/or radiological criteria, a colonoscopy dating back less than 1 year without ulcer in the rectum and presence of complex chronic perianal fistula with a maximum of two internal ports and three external ports. All patients must have social security insurance or equivalent social protection. The aim of this study is to determine the optimal dose corresponding to maximum efficacy 6 months after injection of cells with a treatment-related adverse event rate of 20%.

Ethics and dissemination

The EU CT number 2024-511821-75-00 was approved by the following Ethics Committee: CPP (committee for the protection of persons in French: comité de protection des personnes) Ouest 1 – Tours #2024UEMED-18 and ANSM (French Agency for the Safety of Health and Medicinal Products in French : Agence nationale de sécurité du médicament et des produits de santé) #2024-511821-75-00 (Sponsor number RC31/13/7030, protocol V2.1). The results will be disseminated through conventional scientific channels.

Trial registration number

NCT06636032.

The results will be disseminated through conventional scientific channels.

☐ ☆ ✇ Journal of Advanced Nursing

A Primer of Data Cleaning in Quantitative Research: Handling Missing Values and Outliers

Por: Amir Masoud Sharifnia · Daniel Edem Kpormegbey · Deependra Kaji Thapa · Michelle Cleary — Diciembre 23rd 2025 at 00:53

ABSTRACT

Aims

This paper discusses data errors and offers guidance on data cleaning techniques, with a particular focus on handling missing values and outliers in quantitative datasets.

Design and Methods

Methodological discussion.

Results

This paper provides an overview of various techniques for identifying and addressing data anomalies, which can arise from incomplete, noisy, and inconsistent data. These anomalies can significantly affect data quality, leading to biased model parameter estimates and evidence-based decisions. Data cleaning, particularly the appropriate handling of missing values and outliers, is essential to improving data quality before analysis. Data cleaning includes screening for anomalies, diagnosing errors, and applying appropriate corrective measures.

Conclusion

Proper handling of missing values and the identification and correction of outliers are crucial aspects of data cleaning in ensuring data quality and the reliability of statistical analyses. Effective data cleaning enhances the validity and accuracy of research findings for evidence-based decision making that leads to optimal patient outcomes.

Implications for the Profession

The quality of study results depends on how a dataset and its complexities are processed or handled before the analysis. Nursing researchers must use a framework to identify and address important data anomalies and produce reliable results.

Impact

This paper describes data cleaning, often overlooked during the data mining process, as a crucial step before conducting data analysis. By addressing missing values and outliers, identifying and fixing data anomalies, and enhancing data quality prior to analysis, data cleaning techniques can produce precise research findings for evidence-based decision making.

Reporting Method

In this methodological paper, no new data were generated.

Patient or Public Contribution

No patient or public contribution.

☐ ☆ ✇ Journal of Advanced Nursing

Challenges of Cross‐Cultural Validation of Clinical Assessment Measures: A Practical Introduction

Por: Mousa Alavi · Danielle Le Lagadec · Michelle Cleary — Diciembre 23rd 2025 at 00:53

ABSTRACT

Aims

This paper explores the methodological challenges associated with cross-cultural validation of clinical assessment measures and proposes strategies to enhance the validity and reliability of these assessments.

Design and Methods

Methodological discussion.

Results

Three main phases require consideration in the cross-cultural validation of assessment instruments: (1) Linguistic translation of the assessment instrument and confirmation of its equivalence, which includes conceptual, item, semantic and operational equivalence; (2) Empirical validation of the translated version's accuracy; (3) Adjusting the scores to fit the cultural context.

Conclusion

Achieving cross-cultural equivalence of assessment instruments is a complex and challenging process that can only be achieved through methodological rigour. It requires interdisciplinary collaboration of both linguistic and subject experts with strong statistical knowledge and a willingness to explore the nuances of the target population. By enhancing methodological rigour, we can improve the validity of clinical assessment measures across cultures, ultimately leading to better health outcomes for diverse populations.

Implications for the Profession

The implications of cross-cultural validation of clinical assessment measures/tools for nursing are significant and multifaceted. Overcoming challenges to cross-cultural validation contributes to the professional growth of nurses by equipping them with greater cultural awareness and confidence in the tools' reliability for patient assessment and evaluation. This not only aids in their clinical practice but also fosters a commitment to evidence-based practice, enhancing their overall effectiveness as healthcare providers. Reliable and valid assessment tools enable nurses to confidently engage in research literature that reflects the realities of diverse populations. This can inform healthcare policies and practices, ensuring they are inclusive and equitable.

Impact

While researchers endeavour to reach a consensus on the definition of cross-cultural equivalence and how it should be determined, this practical introduction discusses challenges and proposes strategies to enhance the validity and reliability of these measures/tools.

Patient or Public Contribution

No patient or public contribution.

☐ ☆ ✇ Journal of Advanced Nursing

The Privilege and Power of Peer Review: Advancing Science With Integrity, Vigilance and Fairness

Por: Debra Jackson · Graeme D. Smith · Michelle Cleary — Diciembre 23rd 2025 at 00:53
Journal of Advanced Nursing, Volume 82, Issue 1, Page 1-4, January 2026.
☐ ☆ ✇ Journal of Advanced Nursing

Placement Poverty and the Politics of Nursing Education

Por: Debra Jackson · Brendan McCormack · Kim Usher · Michelle Cleary — Enero 16th 2026 at 16:16
Journal of Advanced Nursing, Volume 82, Issue 2, Page 980-983, February 2026.
☐ ☆ ✇ Journal of Clinical Nursing

Beyond clinical trials: Extending the role of the clinical research nurse into social care and homeless research

Abstract

Aim

Clinical research nurses work at the fulcrum of clinical trials with clearly defined roles and responsibilities. In England, the National Institute for Health Research (the main funder of health research) has broadened its scope to encompass social care research. The expectation is that clinical research nurses will expand their skill set to support these new studies, many of which will employ qualitative and mixed methods. This discussion paper explores the challenges of facilitating this clinical academic workforce development through a case study of a homeless health and social care research project. This was one of the first studies to engage clinical research nurses in this new and expanded role.

Background

Much of what is known about the research nurse workforce has been generated through studies of clinical trials in oncology. The ‘caring-recruiting’ dichotomy has been used as a heuristic device for identifying workforce issues that can impact on study delivery such as how intense pressure to recruit study participants leads to low job satisfaction.

Design

This case study reflects on the authors' experiences of employing a clinical research nurse in a social care research project concerned with the discharge of homeless people from hospital. The ‘caring-recruiting’ dichotomy is used to generate new information about the relationship between workforce development and the successful delivery of social care research.

Conclusion

The case study illuminates how social care research can generate different pressures and ethical challenges for research nurses. The time and skill it took to recruit study participants identified as ‘hard to reach’ was suggestive of the need to move beyond performance measures that prioritise recruitment metrics. The need for different types of staff supervision and training was also warranted as supporting study participants who were homeless was often distressing, leading to professional boundary issues.

Relevance to workforce development

This study highlights that performance management, training and supervisory arrangements must be tailored to the characteristics of each new study coming onto the portfolio to ensure research nurses are fully supported in this new and expanded role.

☐ ☆ ✇ BMJ Open

Impact of intraoperatiVe moderAte positive end-expiratory pressure with reCruitment mAnoeuvres versus low positive end-expiRatory pressure on major postoperative pulMonary complications and death after on-pump cardiac surgery in high-risk patients: the VA

Por: Demaure · N. · Le Cunff · J. · Duchene · M. · Rozec · B. · Espitalier · F. · Cabon · J.-M. · Oilleau · J.-F. · Guerci · P. · Labaste · F. · Abou-Arab · O. · Guinot · P.-G. · Duval · P. · Besnier · E. · Flecher · E. · Leroyer · I. · Morcet · J. · Fougerou-Leurent · C. · Mansour · A. · Nesse — Octubre 29th 2025 at 16:48
Introduction

Postoperative pulmonary complications (PPCs) are common after cardiac surgery and are associated with significant morbidity and mortality. Lung-protective ventilation strategies have been proposed to reduce PPCs, but the optimal level of positive end-expiratory pressure (PEEP) and the use of alveolar recruitment manoeuvres (RMs) remain controversial.

Methods/analysis

In this investigator-initiated, multicentre, open, randomised, parallel-group, superiority clinical trial, elective cardiac surgery patients at risk of PPCs will be assigned to one of two intraoperative ventilation strategies: (1) an open-lung ventilation strategy with protective ventilation, moderate PEEP and RMs or (2) a standard protective ventilation with low PEEP and no RM. The primary outcome will be a composite of prolonged (>24 hour) postoperative mechanical ventilation, reintubation for any cause or hospital-acquired pneumonia within 7 days of surgery, or death within 28 days of surgery. Data will be analysed on an intention-to-treat basis.

Ethics and dissemination

The VACARM (impact of intraoperatiVe moderAte positive end-expiratory pressure with reCruitment mAnoeuvres versus low positive end-expiRatory pressure on major postoperative pulMonary complications and death after on-pump cardiac surgery in high-risk patients) trial has been approved by an independent ethics committee for all study centres. Recruitment began in July 2021. Results will be published in international peer-reviewed medical journals.

Trial registration number

ClinicalTrials.gov NCT04408495.

☐ ☆ ✇ Journal of Advanced Nursing

Advancing evidence‐based practice through the Knowledge Translation Challenge: Nurses’ important roles in research, implementation science and practice change

Por: Amanda Chisholm · Angela Russolillo · Michelle Carter · Marla Steinberg · Leah Lambert · Andrea Knox · Agnes Black — Octubre 18th 2025 at 19:05

Abstract

Aim

To describe a knowledge translation capacity-building initiative and illustrate the roles of nurses in practice change using an exemplar case study.

Design

The report uses observational methods and reflection.

Methods

The Knowledge Translation Challenge program involves a multi-component intervention across several sites. The advisory committee invited eligible teams to attend capacity-building workshops. Implementation plans were developed, and successful teams receive funding for a 2 year period. Evaluation involved collecting data on program uptake and impact on practice change. Data has been collected from five cohorts. The exemplar case study employed an action-research framework.

Results

Four nurse-led teams have demonstrated successful implementation of their practice change. The case study on implementing a clinical toolkit for clozapine management further illustrates a thoughtful planning process, and implementation journey and learnings by a team of nurses.

Conclusion

The Knowledge Translation Challenge program empowers nurses to use implementation science practices to enhance the quality and effectiveness of healthcare services. Success of this initiative serves as a model for addressing the persistent gap between knowledge and practice in clinical settings and the value of activating nurses to help close this gap.

Implications

As the most trusted and numerous profession, it is vital that nurses contribute to efforts to translate research evidence into clinical practice. The Knowledge Translation Challenge program supports nurses to lead practice change.

Impact

The Knowledge Translation Challenge program successfully equips nurses and other health care providers with the knowledge, skills and resources to implement practice improvements which enhance the quality and effectiveness of healthcare services and nursing practice.

Patient or Public Contribution

The Knowledge Translation Challenge advisory committee has three patient-public partners that support teams to develop a patient-oriented approach for their projects by providing feedback on the implementation plans. Each team was also supported to include patient-public partners on their project.

☐ ☆ ✇ BMJ Open

Development and validation of diagnostic and prognostic prediction tools for dental caries in young children through prospective and cross-sectional observational studies: a protocol

Por: Khazaei · Y. · Kodikara · S. · Butler · C. A. · Messina · N. L. · Le Cao · K.-A. · Dashper · S. G. · Silva · M. J. — Octubre 6th 2025 at 02:14
Introduction

Dental caries is the most common oral disease worldwide, affecting up to 90% of children globally. It can lead to pain, infection and impaired quality of life. Early prevention is a key strategy for reducing the prevalence of dental caries in young children. Valid and reliable diagnostic or prognostic tools that enable accurate individualised prediction of current or future dental caries are essential for facilitating personalised caries prevention and early intervention. However, no efficacious tools currently exist in early childhood—the optimal period for disease prevention. We aim to develop and validate diagnostic and prognostic prediction tools for dental caries in young children, using a combination of environmental, physical, behavioural and biological early life data.

Methods and analysis

Data sources include two prospective studies, with a total sample size of approximately 600 children. These cohorts have collected detailed demographic, antenatal, perinatal and postnatal data from medical records and parent-completed questionnaires and biological samples including a dental plaque swab. Candidate predictor variables will include sociodemographic characteristics, health history, behavioural and microbiological characteristics. The outcome variable will be the presence, incidence or severity of dental caries diagnosed using the International Caries Detection and Assessment System. Statistical and machine learning approaches will be used for selection of predictor variables and model development. Internal validation will be conducted using resampling methods (i.e., bootstrapping) and nested cross-validation. Model performance will be evaluated using standard performance metrics such as accuracy, discrimination and calibration. Where feasible, external validation will be performed in an independent cohort. Model development and reporting will be guided by the Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD) statement and the Prediction model Risk Of Bias Assessment Tool (PROBAST) guidelines.

Ethics and dissemination

This study has ethical and governance approval from The Royal Children’s Hospital Melbourne Human Research Ethics Committee (HREC/111803/RCHM-2024). Results of this study will be published in peer-reviewed journals and presented at scientific conferences.

Trial registration number

Infant2Child: ACTRN12622000205730—pre-results; MisBair: NCT01906853—post results.

☐ ☆ ✇ Journal of Advanced Nursing

Constructive Resistance: Essential to Optimise Workplace Quality

Por: Catherine Hungerford · Debra Jackson · Michelle Cleary — Septiembre 25th 2025 at 07:02
Journal of Advanced Nursing, Volume 81, Issue 10, Page 6071-6073, October 2025.
☐ ☆ ✇ BMJ Open

INDIGO randomised controlled digital clinical trial: INvestigating DIgital outcomes and quality of life in cancer survivors - a study protocol

Por: Le Calvez · K. · Gregory · J. J. · Gath · J. · Wheatstone · P. · Ashley · L. · Chinembiri · O. · Cunliffe · A. · Davenport · G. · Jamieson Gilmore · K. · Langel · K. · Miglio · C. · Pakzad-Shahabi · L. · Padmasri · D. · Ruta · D. · Williams · H. · Williams · M. — Septiembre 8th 2025 at 18:11
Introduction

There are estimated to be 3.4 million patients in the UK living after a diagnosis of cancer. We know very little about their quality of life or healthcare usage. Patient-reported outcome measures (PROMs) are tools which help to translate a patient’s quality of life into measurable categories, but how to do this at scale remains underexplored. The study employs a randomised design to assess different engagement strategies for optimising participation, data linkage and questionnaire completion in Northwest London and then nationally, with appropriate research approvals.

Methods and analysis

We have designed and implemented an online, patient-completed, randomised observational trial. We will pilot it in Northwest London before national roll-out, using initially the General Practice (GP) record of a cancer diagnosis and then exploring the use of social media. The primary objective is to explore the feasibility of recruiting participants via self-identification or contact from the primary care research network and obtaining consent to link participants’ PROMs responses to their cancer registry records. Data collection occurs through a secure platform, with participants directly responsible for data entry. There is no formal target sample size because this is a feasibility study, and we want to explore how many patients we can recruit. Analyses will be conducted using descriptive statistics, repeated measures multilevel modelling and machine learning techniques. If a substantial difference in responses between randomisation arms is detected, ineffective strategies will be removed. If no clear difference is observed, recruitment will continue with periodic reviews based on response rates and data completeness.

Ethics and dissemination

The Study Coordination Centre has obtained approval from the London—Surrey Research Ethics Committee and Health Research Authority. We will publish and disseminate the results in local, national and international meetings, in peer-reviewed journals, on social media and on websites.

It has been registered under ‘Investigating Digital Outcomes for Cancer Survivors in the Community’ (NCT06095024).

Trial registration number

NCT06095024: Investigating Digital Outcomes for Cancer Survivors in the Community.

☐ ☆ ✇ Journal of Clinical Nursing

Psychometric Properties of Pain Scales in Inpatient Settings: An Umbrella Review

ABSTRACT

Aims

To identify the pain assessment scales with the best psychometric properties to be used by nurses in an inpatient setting.

Design

Umbrella review.

Methods

A comprehensive search of four databases was conducted for systematic reviews published from July 2013 to November 2024, focusing on psychometric properties of pain scales used in inpatient settings. Inclusion criteria required scales to assess subjective or behavioural pain and be nurse-administered, while reviews without detailed psychometric data were excluded. Screening, quality appraisal (JBI checklist), and data extraction were performed independently by two researchers. Data synthesis combined qualitative and quantitative approaches, with psychometric properties evaluated using the COSMIN checklist. The study was reported in accordance with the Preferred Reporting Items for Overviews of Reviews (PRIOR) statement.

Results

Seventeen articles met the inclusion criteria, identifying 41 scales used across various patient populations, including critical care, paediatric, postoperative, cancer, cerebral palsy, disorders of consciousness, low back and neck pain, stroke and verbal communication disorders. The Paediatric Pain Profile, the Breakthrough Pain Assessment Tool and the Questionnaire on Pain caused by Spasticity demonstrated adequate psychometric properties, although the positive findings for the latter two should be confirmed by at least one additional study. Most of the scales (n = 36) require further studies to validate their use in clinical practice. For two scales, their clinical use remains questionable.

Conclusion

The Paediatric Pain Profile, the Breakthrough Pain Assessment Tool, and the Questionnaire on Pain caused by Spasticity can be recommended for use. Unidimensional scales should complement, rather than replace, multidimensional scales to ensure a comprehensive pain assessment. Standardising documentation with validated scales enhances clinical decision-making, care quality, research usability, and reduces documentation burden.

☐ ☆ ✇ Journal of Clinical Nursing

Prevalence and Determinants of Workplace Violence Against Nurses in the Italian Home Care Settings: A Cross‐Sectional Multicentre Study

ABSTRACT

Aims

To describe the prevalence and determinants of workplace violence against nurses in the Italian home care setting.

Design

Secondary cross-sectional analysis of data from the multicentre study AIDOMUS-IT.

Methods

Nurses employed in home care services provided by Italian Local Health Authorities were interviewed using a variety of instruments. A multivariable binary logistic regression model was performed to model the risk of workplace violence against nurses in the last 12 months. Variables related to violence were selected among sociodemographic characteristics (such as age and gender), work-related factors (including years of experience, team composition, overtime working, previous experience in mental health care, burnout) and organisational elements (including leadership and support, workload, staffing and resources adequacy, and time to reach the patients' homes). Adjusted odds ratios (aOR) were used to present the results.

Results

A total of 3949 nurses participated in the study and 20.49% of them reported to have experienced an episode of violence in the last 12 months. Determinants of higher risk of violence episodes were younger age (aOR = 1.02, p = 0.002), higher workload (aOR = 1.01, p = 0.002), working in a multiprofessional team (aOR = 1.24, p = 0.018), perception of inadequate managerial leadership and support (aOR = 1.38, p = 0.003), and higher burnout levels (aOR = 1.01, p < 0.001).

Conclusion

The prevalence of workplace violence against Italian home care nurses is high. Several modifiable determinants were found to be associated with a higher risk of violence, which can potentially be mitigated with tailored interventions.

Implications for the Profession and/or Patient Care

Effective preventive strategies must be developed to lessen workplace violence against nurses in the home care setting. These strategies should focus on strengthening nursing managers' leadership and support skills, enhancing team-building strategies, avoiding inadequate workload, monitoring nurses' burnout, estimating optimum staffing levels, and assigning advanced-career nurses to home care services. These measures are imperative to guarantee the quality and safety of home care organisations and to attain favourable outcomes in the provision of care.

Impact

This study aimed to explore the prevalence and determinants of workplace violence against nurses in the Italian home care settings. We found that out of the 3949 nurses surveyed, 20% of the sample reported one episode of violence during the last 12 months. Determinants of this violence included younger age, higher workload and burnout, being in a multiprofessional team, and perception of lack of leadership and support by the nurse manager. The results of this study can be used to tailor interventions aimed at mitigating the risk factors of violence, particularly those that can be modified (e.g., workload, burnout, and leadership).

Reporting Method

The study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.

Patient or Public Contribution

No patient or public contribution.

☐ ☆ ✇ Journal of Clinical Nursing

Association of Burnout and Intention‐To‐Leave the Job With Objective Nursing Workload and Nursing Working Environment: A Cross‐Sectional Study Among Intensive Care Nurses

ABSTRACT

Aim

The objectives of this study were to determine the prevalence of burnout risk and intention-to-leave among intensive care unit (ICU) nurses and analyse the association of these with workload and work environment.

Design

A cross-sectional survey of nurses working in ICUs was conducted in France between 15 January 2024 and 15 April 2024 alongside a longitudinal assessment of workload during the same period.

Methods

ICU nurse workload was assessed using the Nursing Activities Score (NAS). The risk of burnout was assessed using the Maslach Burnout Inventory scale and intention-to-leave the hospital was assessed with a binary question. A total of 1271 nurses working in 61 intensive care units completed the questionnaire and 14,134 NAS per patient and 1885 NAS per nurse were included in the study.

Results

The median overall of burnout by hospital site was 64.7% [P25: 53.3–P75: 72.7] for the broad definition and a median of 20.7% [13.3–27.3] of ICU nurses reported an intent-to-leave their job. The median overall NAS score per nurse was 135.9% [121.4–156.9] and the prevalence of NAS scores exceeding 100% per nurse was 73.9% [62.8–80.3]. A significant association was found between nurses working in an ICU with a better work environment and all dimensions of burnout as well as the intention-to-leave the job. A prevalence in the hospital site of NAS scores exceeding 100% per nurse below the median was associated with a lower burnout (OR = 0.69, 95% CI: 0.50–0.88 for broad definition) and intention-to-leave the job (OR = 0.68, 95% CI: 0.50–0.92).

Conclusion

This study found significant associations between burnout and the intention to leave the job for nurses in ICUs, mainly due to a better work environment and, to a lesser extent, a lower workload for nurses.

Implications for the Profession and/or Patient Care

In an era of nurse shortages and absenteeism, it is crucial for institutions to retain their nursing staff. Our results should encourage hospital managers to take action to improve the ICU work environment and keep ICU workloads manageable to decrease burnout and the intention-to-leave the job among ICU nurses.

Reporting Method

This article follows the STROBE guidelines for the reporting of cross-sectional studies.

Patient or Public Contribution

No patient or public contribution.

☐ ☆ ✇ Journal of Clinical Nursing

Exploring the Impact of Medical Complexity on Nursing Complexity of Care in Paediatric Patients: A Retrospective Observational Study

ABSTRACT

Aims

To explore the impact of medical complexity, defined by the number of chronic conditions, on the complexity of care, as described by the frequency of nursing diagnoses (NDs) and nursing actions (NAs), in paediatric patients.

Design

Retrospective observational study.

Methods

This study was conducted in an Italian university hospital and involved the analysis of electronic health records for neonatal and paediatric patients who were consecutively admitted from January to December 2022. The sample was classified into three categories—non-chronic, single chronic and multimorbid patients—according to their clinical profiles. NDs recorded within the first 24 h from patient hospital admission and NAs performed throughout the hospital stay were counted for each group.

Results

Distinct variations in the prevalence and patterns of NDs and NAs were observed across different levels of medical complexity. A significant moderate positive correlation between the number of NDs and NAs was found. However, the frequency of NDs did not directly correlate with the number of chronic conditions. Conversely, a weak but significant negative correlation was identified between the quantity of NAs and the number of chronic conditions. While the frequency of NDs showed a stable but decreasing trend as the number of chronic conditions increased, a higher number of chronic conditions were associated with a lower quantity of NAs.

Conclusions

We discovered a notable variation in the complexity of care across varying levels of medical complexity in paediatric patients. Our findings suggest that the complexity of care does not necessarily correspond to the degree of medical complexity. The observed negative relationship between the number of chronic conditions and the quantity of NAs underscores the need for further research to explore this unexpected finding and its implications for clinical practice.

Implications for the Profession and/or Patient Care

Without the adoption of standardised nursing terminologies, such as nursing diagnoses (NDs) and nursing actions (NAs), assessing the complexity of care in paediatric settings can be challenging. Integrating clinical nursing information systems that incorporate standardised NDs and NAs into electronic health records is crucial for accurately documenting and analysing the complexity of care and its relationship with medical complexity.

Impact

In paediatric patients, the frequency of nursing diagnoses (NDs) at hospital admission is significantly associated with the quantity of nursing actions (NAs) delivered during hospitalisation. However, there is no correlation between the frequency of NDs and medical complexity, as defined by the number of chronic disorders. Specifically, the frequency of NDs decreases with increasing medical complexity, while the quantity of NAs is negatively associated with the number of chronic disorders. This indicates that the complexity of care cannot be inferred solely from medical complexity, and additional factors need to be explored. These findings enhance understanding of how complexity of care relates to medical complexity in paediatric patients. Insights into the prevalence and patterns of NDs and NAs can benefit nurses, managers, researchers and policymakers by informing clinical and organisational decision-making to ensure high-quality care.

Reporting Method

The study adhered to the RECORD Statement.

Patient or Public Contribution

Patients, service users, caregivers or public members were not directly involved in the design, conduct, analysis and interpretation of data or in writing this paper. Patients contributed only to data collection.

☐ ☆ ✇ Journal of Clinical Nursing

Patient‐related decisional regret: An evolutionary concept analysis

Por: Mireille Chehade · Margaret M. Mccarthy · Allison Squires — Mayo 17th 2024 at 12:08

Abstract

Background

Health-related decision-making is a complex process given the variability of treatment options, conflicting treatment plans, time constraints and variable outcomes. This complexity may result in patients experiencing decisional regret following decision-making. Nonetheless, literature on decisional regret in the healthcare context indicates inconsistent characterization and operationalization of this concept.

Aim(s)

To conceptually define the phenomenon of decisional regret and synthesize the state of science on patients' experiences with decisional regret.

Design

A concept analysis.

Methods

Rodgers' evolutionary method guided the conceptualization of this review. An interdisciplinary literature search was conducted from 2003 until 2023 using five databases, PubMed, CINAHL, Embase, PsycINFO and Web of Science. The search informed how the concept manifested across health-related literature. We used PRISMA-ScR checklist to guide the reporting of this review.

Results

Based on the analysis of 25 included articles, a conceptual definition of decisional regret was proposed. Three defining attributes underscored the negative cognitive-emotional nature of this concept, post-decisional experience relating to the decision-making process, treatment option and/or treatment outcome and an immediate or delayed occurrence. Antecedents preceding decisional regret comprised initial psychological or emotional status, sociodemographic determinants, impaired decision-making process, role regret, conflicting treatment plans and adverse treatment outcomes. Consequences of this concept included positive and negative outcomes influencing quality of life, health expectations, patient-provider relationship and healthcare experience appraisal. A conceptual model was developed to summarize the concept's characteristics.

Conclusion

The current knowledge on decisional regret is expected to evolve with further exploration of this concept, particularly for the temporal dimension of regret experience. This review identified research, clinical and policy gaps informing our nursing recommendations for the concept's evolution.

No Patient or Public Contribution

This concept analysis examines existing literature and does not require patient-related data collection. The methodological approach does not necessitate collaboration with the public.

☐ ☆ ✇ Journal of Clinical Nursing

Post‐operative nursing activities to prevent wound complications in patients undergoing colorectal surgeries: A scoping review

Abstract

Aims

To identify postoperative interventions and quality improvement initiatives used to prevent wound complications in patients undergoing colorectal surgeries, the types of activities nurses undertake in these interventions/initiatives and how these activities align with nurses' scope of practice.

Design

A scoping review.

Data Sources

Three health databases were searched, and backward and forward citation searching occurred in April 2022. Research and quality improvement initiatives included focussed on adult patients undergoing colorectal surgery, from 2010 onwards. Data were extracted about study characteristics, nursing activities and outcomes. The ‘Dimensions of the scope of nursing practice’ framework was used to classify nursing activities and then the Patterns, Advances, Gaps, Evidence for practice and Research recommendations framework was used to synthesise the review findings.

Results

Thirty-seven studies were included. These studies often reported negative wound pressure therapy and surgical site infection bundle interventions/initiatives. Nurses' scope of practice was most frequently ‘Technical procedure and delegated medical care’ meaning nurses frequently acted under doctors' orders, with the most common delegated activity being dressing removal.

Conclusion

The full extent of possible interventions nurses could undertake independently in the postoperative period requires further exploration to improve wound outcomes and capitalise on nurses' professional role.

Impact Statement

Nurses' role in preventing postoperative wound complications is unclear, which may inhibit their ability to influence postoperative outcomes. In the postoperative period, nurses undertake technical activities, under doctors' orders to prevent wound infections. For practice, nurses need to upkeep and audit their technical skills. New avenues for researchers include exploration of independent activities for postoperative nurses and the outcomes of these activities.

Implications for the Profession and/or Patient Care

There may be opportunities to broaden nurses' scope of practice to act more autonomously to prevent wound complication.

Reporting Method

Scoping Reviews (PRISMA-ScR) checklist.

Patient or Public Contribution

A health consumer interpreted the data and prepared the manuscript.

☐ ☆ ✇ Journal of Clinical Nursing

Association between health literacy and nursing care in hospital: A retrospective study

Abstract

Aims

To describe the health literacy (HL) levels of hospitalised patients and their relationship with nursing diagnoses (NDs), nursing interventions and nursing measures for clinical risks.

Design

Retrospective study.

Methods

The study was conducted from December 2020 to December 2021 in an Italian university hospital. From 146 wards, 1067 electronic nursing records were randomly selected. The Single-Item Literacy Screener was used to measure HL. Measures for clinical risks were systematically assessed by nurses using Conley Index score, the Blaylock Risk Assessment Screening Score, Braden score, and the Barthel Index. A univariable linear regression model was used to assess the associations of HL with NDs.

Results

Patients with low HL reported a higher number of NDs, interventions and higher clinical risks. HL can be considered a predictor of complexity of care.

Conclusions

The inclusion of standardised terms in nursing records can describe the complexity of care and facilitate the predictive ability on hospital outcomes.

Implications for the profession and/or patient care

HL evaluation during the first 24 h. From hospital admission could help to intercept patients at risk of higher complexity of care. These results can guide the development of interventions to minimise needs after discharge.

Patient or Public Contribution

No patient or public contribution was required to design or undertake this research. Patients contributed only to the data collection.

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