Conectar
To test the feasibility and acceptability of a newly developed model of neonatal nurse-controlled analgesia to manage pain in the post-operative infant.
The study utilised a single-centre two-arm parallel, unblinded randomised controlled external pilot trial design.
The pilot trial was conducted in a surgical neonatal tertiary intensive care unit in Brisbane, Australia. Eligible infants were randomised to receive either post-operative pain management care via a model of neonatal nurse-controlled analgesia or standard care. Feasibility and acceptability were the primary outcomes. Seven feasibility outcomes were assessed by a traffic light system to delineate progression to a larger trial. Acceptability and clinical utility of the model of care by staff were assessed by feedback from an anonymous questionnaire that was administered at the completion of the trial period. Secondary outcomes included parental attitudes and perceptions of post-operative pain management to help establish primary outcomes for a larger randomised controlled trial.
Overall staff found the formalised model beneficial for managing post-operative pain but found the complexity of the model and ability to titrate analgesia based only on documented pain scores barriers requiring further consideration. Three of the seven feasibility outcomes failed to reach ‘greenlight’ targets to progress to a larger trial with adherence to the model, and the proportion of eligible infants not recruited was allocated a ‘redlight’. Secondary outcomes were comparable and support future study.
This pilot feasibility study has shown that a model of neonatal nurse-controlled analgesia can be safely implemented and utilised in the post-operative care of the surgical neonate. Further exploration of the barriers to model adherence and recruitment is warranted before a future larger trial is undertaken.
Though not all primary outcomes reached an acceptable range for further progression, this pilot feasibility study provided invaluable learning and has provided direction for future research into the provision of a family integrated and responsive model of analgesia.
This study is reported in line with the Consolidated Standards of Reporting Trials (CONSORT): Extension to randomised pilot and feasibility trial and the TIDieR Checklist (Template for Intervention, Description and Replication).
No patient or public contribution was utilised for this study.
Trial Registration: ACTRN12623000643673—the trial was prospectively registered
by Tamara Muir, Chandra Sharma Poudyal, Romana De Lima, Farah Otaki
IntroductionCOVID-19 pandemic emerged in late 2019, leading to global disruption and forcing people to adapt to a new reality. The intensity of the pandemic affected many organisations’ preparedness, response, and recovery efforts, causing numerous businesses to struggle. Although no single theory fully explains why some businesses thrived during this time, the concept of organisational resilience stands out. Organisations with a resilient culture seemed better equipped to address risks, adapt effectively, and seize opportunities for innovation. Therefore, the purpose of the current study is to critically examine the response to COVID-19 of a medicine and health sciences university in Dubai, United Arab Emirates.
MethodsThe study relied on a convergent mixed methods approach to research. A tailor-made questionnaire was used to collect quantitative data using two 5-point Likert-type scales: ‘Opinions about Organizational Response’ and ‘Conducive Organizational Response Behaviours’ (where 110 current employees who were tenured during COVID-19 were selected, using purposive, non-probability sampling, and in turn invited to participate). Semi-structured interviews were conducted to collect qualitative data [where seven respondents who had completed the questionnaire and agreed to participate in follow-up interviews were selected (i.e., convenience, nonprobability sampling) and in turn invited to participate]. The quantitative data were descriptively and inferentially analysed. Qualitative data was analysed using an inductive six-step thematic approach. The quantitative findings were mapped onto the output of qualitative analysis using the iterative joint display analysis process.
ResultsA total of 70 employees completed the questionnaire (63.64%), and six out of seven invitees participated in the semi-structured interviews. The percentage of the total extent of agreement of ‘Opinions about Organizational Response’ score was 90.94%. As for the percentage of the total frequency of observation of ‘Conducive Organizational Response Behaviours’ score, it was 95.08%. The qualitative analysis generated a conceptual model, namely: ‘Enablers of Organizational Resilience’, with five interlinked themes namely: Preparedness and planning for uncertainty, Adaptation and agility, Team cohesion, Social responsibility, and Learning organisation. Four meta-inferences emerged from integrating the data findings: Response characteristics, Behaviour specificities, Consistency of opinions, and the Fundamental role of organizational culture.
ConclusionThe findings reveal that organizations, in the intersect between higher education and public health, should continue on innovatively investing in agile leadership, strategic partnerships, and a robust continuous learning and development culture to better navigate future disruptions.
To evaluate the psychometric properties of the Hospital Survey on Patient Safety Culture (HSoPSC) version 2.0 in Ethiopian public hospitals.
A cross-sectional study.
Five public hospitals in Eastern Ethiopia.
Healthcare professionals (N=582).
An adapted and contextualised version of HSoPSC 2.0 was used to conduct structural validity using exploratory and confirmatory factor analyses (EFA and CFA). Convergent and discriminant validity were evaluated through item loadings and interfactor correlations, respectively. Reliability was measured using McDonald’s omega and Cronbach’s alpha.
CFA indicated a poor model fit for the original 10-factor, 32-item HSoPSC 2.0 across all statistical indices: relative chi-square (²/df=7.71), root mean square error of approximation (RMSEA=0.108), standardised root mean square residual (SRMR=0.088), comparative fit index (CFI=0.814) and Tucker-Lewis’s index (TLI=0.780). Consequently, a comprehensive EFA was conducted, which identified a revised model comprising 5-factor, 21-item. This model accounted for 62.8% of the total variance and demonstrated strong construct validity, with excellent fit indices (²/df=3.67, RMSEA=0.068, SRMR=0.034, CFI=0.969, TLI=0.945). Internal consistency, assessed via McDonald’s omega and Cronbach’s alpha, exceeded the acceptable threshold of 0.70 across all dimensions, except for Response to Error (0.66). The convergent and discriminant validity of the new model was confirmed, ensuring an accurate representation of the underlying constructs.
The original HSoPSC 2.0 with 10-factor, 32-item failed to demonstrate structural validity in the Ethiopian healthcare context. In contrast, a revised 5-factor, 21-item model showed strong validity and acceptable reliability. This adapted version provides a culturally and contextually relevant tool for assessing patient safety culture in Ethiopian healthcare settings.
Early-onset chronic liver disease (CLD) and its subsequent clinical progression have systemic impact. Its trajectory coincides with critical periods of brain development. In this study, we will test the hypothesis that early-onset CLD is associated with neurodevelopmental and psychiatric symptoms and delineate their neurobiological underpinnings through multimodal neuroimaging.
This study will recruit 100 patients with biliary atresia and 50 patients with other types of early-onset CLD, aged between 6 and 30 years, under the primary care of Paediatric Liver Services at King’s College Hospital, London, UK. Cognitive performance and autism-related behaviours will be evaluated with neurodevelopmental assessments. Participants and their parents will complete questionnaires addressing neurodevelopmental and psychiatric outcomes in everyday life, and quality of life. Multimodal neuroimaging will be conducted using electroencephalography (EEG); eye-tracking; structural, functional and diffusion MRI; and magnetic resonance spectroscopy (MRS). Clinical information will be collected from patients’ medical records and bio samples. Data of 222 neurotypical controls and 307 neurodivergent controls without CLD will be pooled from the Longitudinal European Autism Project with a similar study protocol. Neurodevelopmental and psychiatric outcomes will be compared with normative values and between groups. Associations with clinical risk factors will be explored using multivariable regression. Neuroimaging markers will be compared between groups and associations with neurodevelopmental outcomes and clinical risk factors will be tested using multivariable regression. Individual deviation from normal brain development will be quantified using Bayesian modelling and will be associated with neurodevelopmental outcomes.
This study was approved by the National Health Service Health Research Authority’s ethical committee (REC reference: 22/PR/1587). Findings from this study will be published in peer-reviewed journals, presented at national and international conferences and shared with patients and their families for widespread dissemination of the results.
The incidence of anal carcinoma is increasing, with the current gold standard treatment being chemoradiotherapy. There is currently a wide range in the radiotherapy dose used internationally which may lead to overtreatment of early-stage disease and potential undertreatment of locally advanced disease.
PLATO is an integrated umbrella trial protocol which consists of three trials focused on assessing risk-adapted use of adjuvant low-dose chemoradiotherapy in anal margin tumours (ACT3), reduced-dose chemoradiotherapy in early anal carcinoma (ACT4) and dose-escalated chemoradiotherapy in locally advanced anal carcinoma (ACT5), given with standard concurrent chemotherapy.
The primary endpoints of PLATO are locoregional failure (LRF)-free rate for ACT3 and ACT4 and LRF-free survival for ACT5. Secondary objectives include acute and late toxicities, colostomy-free survival and patient-reported outcome measures. ACT3 will recruit 90 participants: participants with removed anal tumours with margins ≤1 mm will receive lower dose chemoradiotherapy, while participants with anal tumours with margins >1 mm will be observed. ACT4 will recruit 162 participants, randomised on a 1:2 basis to receive either standard-dose intensity modulated radiotherapy (IMRT) in combination with chemotherapy or reduced-dose IMRT in combination with chemotherapy. ACT5 will recruit 459 participants, randomised on a 1:1:1 basis to receive either standard-dose IMRT in combination with chemotherapy, or one of two increased-dose experimental arms of IMRT with synchronous integrated boost in combination with chemotherapy.
This study has been approved by Yorkshire & The Humber – Bradford Leeds Research Ethics Committee (ref: 16/YH/0157, IRAS: 204585), July 2016. Results will be disseminated via national and international conferences, peer-reviewed journal articles and social media. A plain English report will be shared with the study participants, patients’ organisations and media.
Commentary on: Douglas C, Alexeev S, Middleton S, Gardner G, Kelly P, McInnes E, et al. Transforming nursing assessment in acute hospitals: A cluster randomised controlled trial of an evidence-based nursing core assessment (the ENCORE trial). International Journal of Nursing Studies. 2024. 2024;151:104690.
Implications for practice and research Introducing training to enhance manual nursing assessment and surveillance has the potential to improve outcomes for hospitalised patients with multimorbidity. Further research is needed to establish which aspects of nursing assessment and surveillance are essential to improving recognition and response to clinical deterioration.
Failure to identify and respond to deteriorating patients is a significant and complex clinical safety issue. There is a growing body of international research evidence which has identified the importance of system and human factors in ‘failure to rescue’ events.
Commentary on: Drennan J, Murphey A, McCarthy VJC, Ball J, Duffield C, Crouch R, Kelly G, Loughnane C, Murphey A, Hegarty J, Brady N, Scott A & Griffiths P. The association between nurse staffing and quality of care in emergency departments: A systematic review. Int J Nurs Stud 2024 153, 104 706.
Implications for practice and research Healthcare leaders should place high importance on ensuring adequate levels of nursing staff in emergency departments to reduce serious adverse outcomes. Further research is needed to ascertain safe nurse staffing levels in emergency departments.
There is a substantial body of international evidence, which demonstrates that inadequate nurse staffing is associated with increased mortality and poor patient outcomes in medical and surgical settings.
Commentary on: Roussel M, Teissandier D, Yordanov Y, et al. Overnight stay in the emergency department and mortality in older patients. JAMA Intern Med. 2023 Dec 1;183(12):1378-1385.
Healthcare leaders should place high importance on organisational solutions to prioritise the admission of older patients from emergency departments (EDs) to wards to reduce risks associated with overnight stays. Further evidence is needed to understand if increased risks to older patients in ED also occur at other times and to establish the most effective interventions to mitigate risks.
Crowding and access block in emergency departments (EDs) are pervasive problems of international concern.
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