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Evidence for clinician underprescription of and patient non-adherence to guideline-recommended cardiovascular medications among adults with peripheral artery disease: protocol for a systematic review and meta-analysis

Por: de Launay · D. · Paquet · M. · Kirkham · A. M. · Graham · I. D. · Fergusson · D. A. · Nagpal · S. K. · Shorr · R. · Grimshaw · J. M. · Roberts · D. J.
Introduction

International guidelines recommend that adults with peripheral artery disease (PAD) be prescribed antiplatelet, statin and antihypertensive medications. However, it is unclear how often people with PAD are underprescribed these drugs, which characteristics predict clinician underprescription of and patient non-adherence to guideline-recommended cardiovascular medications, and whether underprescription and non-adherence are associated with adverse health and health system outcomes.

Methods and analysis

We will search MEDLINE, EMBASE and Evidence-Based Medicine Reviews from 2006 onwards. Two investigators will independently review abstracts and full-text studies. We will include studies that enrolled adults and reported the incidence and/or prevalence of clinician underprescription of or patient non-adherence to guideline-recommended cardiovascular medications among people with PAD; adjusted risk factors for underprescription of/non-adherence to these medications; and adjusted associations between underprescription/non-adherence to these medications and outcomes. Outcomes will include mortality, major adverse cardiac and limb events (including revascularisation procedures and amputations), other reported morbidities, healthcare resource use and costs. Two investigators will independently extract data and evaluate study risk of bias. We will calculate summary estimates of the incidence and prevalence of clinician underprescription/patient non-adherence across studies. We will also conduct subgroup meta-analyses and meta-regression to determine if estimates vary by country, characteristics of the patients and treating clinicians, population-based versus non-population-based design, and study risks of bias. Finally, we will calculate pooled adjusted risk factors for underprescription/non-adherence and adjusted associations between underprescription/non-adherence and outcomes. We will use Grading of Recommendations, Assessment, Development and Evaluation to determine estimate certainty.

Ethics and dissemination

Ethics approval is not required as we are studying published data. This systematic review will synthesise existing evidence regarding clinician underprescription of and patient non-adherence to guideline-recommended cardiovascular medications in adults with PAD. Results will be used to identify evidence-care gaps and inform where interventions may be required to improve clinician prescribing and patient adherence to prescribed medications.

PROSPERO registration number

CRD42022362801.

Dogs’ social susceptibility is differentially affected by various dog–Human interactions. A study on family dogs, former shelter dogs and therapy dogs

by Anna Kis, Katinka Tóth, Lívia Langner, József Topál

When pre-treated with social stimuli prior to testing, dogs are more susceptible to human influence in a food preference task. This means, after a positive social interaction they are more willing to choose the smaller amount of food indicated by the human, as opposed to their baseline preference for the bigger amount. In the current study we investigate if and how various forms of social interaction modulate choices in the same social susceptibility task, testing dogs with varying early life history (pet dogs, therapy dogs, former shelter dogs). In line with previous studies, dogs in general were found to be susceptible to human influence as reflected in the reduced number of “bigger” choices in the human influence, compared to baseline, trials. This was true not only for pet dogs with a normal life history, but also for dogs adopted from a shelter. Therapy dogs, however, did not uniformly change their preference for the bigger quantity of food in the human influence trials; they only did so if prior to testing they had been pre-treated with social stimuli by their owner (but not by a stranger). Pet dogs were also more influenced after pre-treatment with social stimuli by their owner compared to ignoring and separation; however after pre-treatment by a stranger their behaviour did not differ from ignoring and separation. Former shelter dogs on the other hand were equally influenced regardless of pre-treatment by owner versus stranger. In summary these results show that dogs’ social susceptibility is modulated by both interactions immediately preceding the test as well as by long term social experiences.

Health-related quality of life after 12 months post discharge in patients hospitalised with COVID-19-related severe acute respiratory infection (SARI): a prospective analysis of SF-36 data and correlation with retrospective admission data on age, disease

Por: Wright · G. · Senthil · K. · Zadeh-Kochek · A. · Au · J. H.-s. · Zhang · J. · Huang · J. · Saripalli · R. · Khan · M. · Ghauri · O. · Kim · S. · Mohammed · Z. · Alves · C. · Koduri · G.

Long-term outcome and ‘health-related quality of life’ (HRQoL) following hospitalisation for COVID-19-related severe acute respiratory infection (SARI) is limited.

Objective

To assess the impact of HRQoL in patients hospitalised with COVID-19-related SARI at 1 year post discharge, focusing on the potential impact of age, frailty, and disease severity.

Method

Routinely collected outcome data on 1207 patients admitted with confirmed COVID-19 related SARI across all three secondary care sites in our NHS trust over 3 months were assessed in this retrospective cohort study. Of those surviving 1 year, we prospectively collected 36-item short form (SF-36) HRQoL questionnaires, comparing three age groups (

Results

Overall mortality was 46.5% in admitted patients. In our SF-36 cohort (n=169), there was a significant reduction in all HRQoL domains versus normative data; the most significant reductions were in the physical component (pemotional component (physical well-being versus CFS (the correlation coefficient=–0.37, p

Conclusion

There was a significant reduction in all SF-36 domains at 1 year. Poor CFS at admission was associated with a significant and prolonged impact on physical parameters at 1 year. Age had little impact on the severity of HRQoL, except in the domains of physical functioning and the overall physical component.

Operational priorities for engaging with Indias private healthcare sector for the control of tuberculosis: a modelling study

Por: Ricks · S. · Singh · A. · Sodhi · R. · Pal · A. · Arinaminpathy · N.
Objectives

To estimate the potential impact of expanding services offered by the Joint Effort for Elimination of Tuberculosis (JEET), the largest private sector engagement initiative for tuberculosis (TB) in India.

Design

We developed a mathematical model of TB transmission dynamics, coupled with a cost model.

Setting

Ahmedabad and New Delhi, two cities with contrasting levels of JEET coverage.

Participants

Estimated patients with TB in Ahmedabad and New Delhi.

Interventions

We investigated the epidemiological impact of expanding three different public–private support agency (PPSA) services: provider recruitment, uptake of cartridge-based nucleic acid amplification tests and uptake of adherence support mechanisms (specifically government supplied fixed-dose combination drugs), all compared with a continuation of current TB services.

Results

Our results suggest that in Delhi, increasing the use of adherence support mechanisms among private providers should be prioritised, having the lowest incremental cost-per-case-averted between 2020 and 2035 of US$170 000 (US$110 000–US$310 000). Likewise in Ahmedabad, increasing provider recruitment should be prioritised, having the lowest incremental cost-per-case averted of US$18 000 (US$12 000–US$29 000).

Conclusion

Results illustrate how intervention priorities may vary in different settings across India, depending on local conditions, and the existing degree of uptake of PPSA services. Modelling can be a useful tool for identifying these priorities for any given setting.

Patient characteristics, surgery outcomes, presumed aetiology and other characteristics of fistula surgeries and related procedures supported by Fistula Foundation from 2019 to 2021: a multicentre, retrospective observational study

Por: Pollaczek · L. · Rajagopal · K. · Chu · J.
Objectives

Obstetric fistula is a devastating childbirth injury primarily caused by prolonged, obstructed labour. It leaves women incontinent, severely stigmatised and isolated. Fistula repair surgery can restore a woman’s health and well-being. Fistula Foundation, a non-profit organisation, works in partnership with local hospitals and community organisations in Africa and Asia to address key barriers to treatment and to increase the number of women receiving surgical care. This paper presents data on fistula and fistula repair surgery across a large global network of hospitals supported by Fistula Foundation. The data were collected between 2019 and 2021.

Design

Multicentre, retrospective, observational, descriptive study.

Setting and participants

The study analysed deidentified data from 24 568 surgical repairs supported by Fistula Foundation to treat women with obstetric fistula at 110 hospitals in 27 countries.

Results

The data highlight patient characteristics and key trends and outcomes from obstetric fistula repair surgeries and related procedures. Of those surgeries, 87% resulted in a successful outcome (fistula dry and closed) at the time of discharge, highlighting the effectiveness of fistula repair in restoring continence and improving quality of life. Over the period studied, the number of supported surgeries increased by 14%, but there remains an urgent need to strengthen local surgical capacity and improve access to treatment. Women suffered an average of 5.7 years before they received surgery and only 4% of women sought care independently. This underscores the importance of enhancing community awareness and strengthening referral networks.

Conclusions

This research provides essential insight from a vast, global network of hospitals providing highly effective fistula repair surgery. Further investment is needed to strengthen surgical capacity, increase awareness of fistula and remove financial barriers to treatment if stakeholders are to make significant progress towards the United Nations’ ambitious vision of ending fistula by 2030.

Assessing the acceptability of, adherence to and preference for a dual prevention pill (DPP) for HIV and pregnancy prevention compared to oral pre-exposure prophylaxis (PrEP) and oral contraception taken separately: protocols for two randomised, controlle

Por: Friedland · B. A. · Mgodi · N. M. · Palanee-Phillips · T. · Mathur · S. · Plagianos · M. G. · Bruce · I. V. · Lansiaux · M. · Murombedzi · C. · Musara · P. · Dandadzi · A. · Reddy · K. · Ndlovu · N. · Zulu · S. K. · Shale · L. R. · Zieman · B. · Haddad · L. B.
Introduction

Oral pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention method; however, uptake and persistence have been low among southern African women. A dual prevention pill (DPP) that combines PrEP with oral contraception (OC) may increase PrEP use and better meet women’s sexual and reproductive health needs. We will gauge the DPP’s acceptability in two cross-over clinical trials.

Methods and analysis

PC952 (Zimbabwe) and PC953 (South Africa) will compare acceptability, adherence and preference for an over-encapsulated DPP versus PrEP and OCs taken separately. HIV-negative, non-pregnant cisgender females in Johannesburg, South Africa (n=96, 16–40 years) and Harare, Zimbabwe (n=30, 16–24 years) will be randomised 1:1 to the order of regimens—DPP or two separate tablets—each used for three 28-day cycles, followed by a 6-month choice period in South Africa. Monthly clinic visits include HIV and pregnancy testing; safety assessments and risk reduction and adherence counselling. We will assess adherence (monthly) based on tenofovir diphosphate drug levels in dried blood spots and by self-report. We will evaluate acceptability (monthly) and preference (end of cross-over) via computer-assisted self-interviewing and in-depth interviews with a subset of participants. Data collection started in September 2022 and ended in January 2024.

Ethics and dissemination

PC952 was approved by the Ministry of Health and Child Care, Medical Research Council, Research Council and Medicines Control Authority of Zimbabwe; the Chitungwiza City Health Ethics Committee; and the Joint Research Ethics Committee for the University of Zimbabwe Faculty of Medicine and Health Sciences and Parirenyatwa Group of Hospitals. PC953 was approved by the South African Health Products Regulatory Authority and the University of the Witwatersrand’s Human Research Ethics Committee. The Population Council IRB approved both studies. We will disseminate results in open-access journals, clinical trials registries, and at local and international meetings and conferences.

Trial registration numbers

NCT04778514, NCT04778527.

Randomised trials conducted using cohorts: a scoping review

Por: Nickolls · B. J. · Relton · C. · Hemkens · L. · Zwarenstein · M. · Eldridge · S. · McCall · S. J. · Griffin · X. L. · Sohanpal · R. · Verkooijen · H. M. · Maguire · J. L. · McCord · K. A.
Introduction

Cohort studies generate and collect longitudinal data for a variety of research purposes. Randomised controlled trials (RCTs) increasingly use cohort studies as data infrastructures to help identify and recruit trial participants and assess outcomes.

Objective

To examine the extent, range and nature of research using cohorts for RCTs and describe the varied definitions and conceptual boundaries for RCTs using cohorts.

Design

Scoping review.

Data sources

Searches were undertaken in January 2021 in MEDLINE (Ovid) and EBM Reviews—Cochrane Methodology Registry (Final issue, third Quarter 2012).

Eligibility criteria

Reports published between January 2007 and December 2021 of (a) cohorts used or planned to be used, to conduct RCTs, or (b) RCTs which use cohorts to recruit participants and/or collect trial outcomes, or (c) methodological studies discussing the use of cohorts for RCTs.

Data extraction and synthesis

Data were extracted on the condition being studied, age group, setting, country/continent, intervention(s) and comparators planned or received, unit of randomisation, timing of randomisation, approach to informed consent, study design and terminology.

Results

A total of 175 full-text articles were assessed for eligibility. We identified 61 protocols, 9 descriptions of stand-alone cohorts intended to be used for future RCTs, 39 RCTs using cohorts and 34 methodological papers.

The use and scope of this approach is growing. The thematics of study are far-ranging, including population health, oncology, mental and behavioural disorders, and musculoskeletal conditions.

Authors reported that this approach can lead to more efficient recruitment, more representative samples, and lessen disappointment bias and crossovers.

Conclusion

This review outlines the development of cohorts to conduct RCTs including the range of use and innovative changes and adaptations. Inconsistencies in the use of terminology and concepts are highlighted. Guidance now needs to be developed to support the design and reporting of RCTs conducted using cohorts.

An objective comparative study of non‐surgical cleansing techniques and cleanser types in bacterial burden management

Abstract

Cleansing is a vital component of effective wound hygiene and biofilm management, often accomplished through vigorous mechanical action or through soaking with moistened gauze. In the present study, a quantitative comparison of the effectiveness of different cleansing techniques and solutions in removing bacteria was conducted on 71 chronic wounds using bacterial fluorescence imaging as a real-time diagnostic for moderate to high bacterial loads. Vigorous gauze cleansing for 30 s proved most effective by reducing bacterial fluorescence by 33.99%, surpassing 10-min soaking in bacterial reduction (13.24%). Among different cleansers, no statistically significant differences in effectiveness were observed, but povidone-iodine showed the strongest trend towards bacterial reduction. Sub-analysis highlighted the superiority of antiseptic cleansers over saline and gentle soap (−33.30% vs. −1.80% bacterial reduction respectively). Five percent acetic acid was also shown to be more effective in removing specific bacterial strains (Pseudomonas aeruginosa). Findings from studies like this contribute to refining wound hygiene guidelines and clinical algorithms for bacterial and biofilm management.

Therapeutic interventions on human breast cancer xenografts promote systemic dissemination of oncogenes

by Gorantla V. Raghuram, Kavita Pal, Gaurav Sriram, Afzal Khan, Ruchi Joshi, Vishalkumar Jadhav, Sushma Shinde, Alfina Shaikh, Bhagyeshri Rane, Harshada Kangne, Indraneel Mittra

Metastatic dissemination following successful treatment of the primary tumour remains a common cause of death. There is mounting evidence that therapeutic interventions themselves may promote development of metastatic disease. We earlier reported that cell-free chromatin particles (cfChPs) released from dying cancer cells are potentially oncogenic. Based on this observation we hypothesized that therapeutic interventions may lead to the release of cfChPs from therapy induced dying cancer cells which could be carried via the blood stream to distant organs to transform healthy cells into new cancers that would masquerade as metastasis. To test this hypothesis, we generated xenografts of MDA-MB-231 human breast cancer cells in severe combined immune-deficient mice, and using immuno-fluorescence and FISH analysis looked for cfChPs in their brain cells. We detected multiple human DNA signals representing cfChPs in nuclei of brain cells of mice which co-localized with eight human onco-proteins. No intact MDA-MB-231 cells were detected. The number of co-localizing human DNA and human c-Myc signals increased dramatically following treatment with chemotherapy, localized radiotherapy or surgery, which could be prevented by concurrent treatment with three different cfChPs deactivating agents. These results suggest that therapeutic interventions lead to the release cfChPs from therapy induced dying cancer cells carrying oncogenes and are transported via the blood stream to brain cells to potentially transform them to generate new cancers that would appear as metastases. cfChPs induced metastatic spread of cancer is preventable by concurrent treatment with agents that deactivate cfChPs.

Online platform for cardiopulmonary resuscitation and automated external defibrillator training in a rural area: a community clinical trial protocol

Por: Taverna-Llaurado · E. · Martinez-Torres · S. · Granado-Font · E. · Palleja-Millan · M. · del Pozo · A. · Roca-Biosca · A. · Martin-Lujan · F. · Rey-Renones · C.
Introduction

Sudden death resulting from cardiorespiratory arrest carries a high mortality rate and frequently occurs out of hospital. Immediate initiation of cardiopulmonary resuscitation (CPR) by witnesses, combined with automated external defibrillator (AED) use, has proven to double survival rates. Recognising the challenges of timely emergency services in rural areas, the implementation of basic CPR training programmes can improve survival outcomes. This study aims to evaluate the effectiveness of online CPR-AED training among residents in a rural area of Tarragona, Spain.

Methods

Quasi-experimental design, comprising two phases. Phase 1 involves assessing the effectiveness of online CPR-AED training in terms of knowledge acquisition. Phase 2 focuses on evaluating participant proficiency in CPR-AED simulation manoeuvres at 1 and 6 months post training. The main variables include the score difference between pre-training and post-training test (phase 1) and the outcomes of the simulated test (pass/fail; phase 2). Continuous variables will be compared using Student’s t-test or Mann-Whitney U test, depending on normality. Pearson’s 2 test will be applied for categorical variables. A multivariate analysis will be conducted to identify independent factors influencing the main variable.

Ethics and dissemination

This study adheres to the tenets outlined in the Declaration of Helsinki and of Good Clinical Practice. It operated within the Smartwatch project, approved by the Clinical Research Ethics Committee of the Primary Care Research Institute IDIAP Jordi Gol i Gurina Foundation, code 23/081-P. Data confidentiality aligns with Spanish and European Commission laws for the protection of personal data. The study’s findings will be published in peer-reviewed journals and presented at scientific meetings.

Trial registration number

NCT05747495.

Efficacy and safety of autologous haematopoietic stem cell transplantation versus alemtuzumab, ocrelizumab, ofatumumab or cladribine in relapsing remitting multiple sclerosis (StarMS): protocol for a randomised controlled trial

Por: Brittain · G. · Petrie · J. · Duffy · K. E. M. · Glover · R. · Hullock · K. · Papaioannou · D. · Roldan · E. · Beecher · C. · Bursnall · M. · Ciccarelli · O. · Coles · A. J. · Cooper · C. · Giovannoni · G. · Gabriel · I. · Kazmi · M. · Kyriakou · C. · Nicholas · R. · Paling · D. · Peniket
Introduction

Autologous haematopoietic stem cell transplantation (aHSCT) is increasingly used as treatment for patients with active multiple sclerosis (MS), typically after failure of disease-modifying therapies (DMTs). A recent phase III trial, ‘Multiple Sclerosis International Stem Cell Transplant, MIST’, showed that aHSCT resulted in prolonged time to disability progression compared with DMTs in patients with relapsing remitting MS (RRMS). However, the MIST trial did not include many of the current high-efficacy DMTs (alemtuzumab, ocrelizumab, ofatumumab or cladribine) in use in the UK within the control arm, which are now offered to patients with rapidly evolving severe MS (RES-MS) who are treatment naïve. There remain, therefore, unanswered questions about the relative efficacy and safety of aHSCT over these high-efficacy DMTs in these patient groups. The StarMS trial (Autologous Stem Cell Transplantation versus Alemtuzumab, Ocrelizumab, Ofatumumab or Cladribine in Relapsing Remitting Multiple Sclerosis) will assess the efficacy, safety and long-term impact of aHSCT compared with high-efficacy DMTs in patients with highly active RRMS despite the use of standard DMTs or in patients with treatment naïve RES-MS.

Methods and analysis

StarMS is a multicentre parallel-group rater-blinded randomised controlled trial with two arms. A total of 198 participants will be recruited from 19 regional neurology secondary care centres in the UK. Participants will be randomly allocated to the aHSCT arm or DMT arm in a 1:1 ratio. Participants will remain in the study for 2 years with follow-up visits at 3, 6, 9, 12, 18 and 24 months postrandomisation. The primary outcome is the proportion of patients who achieve ‘no evidence of disease activity’ during the 2-year postrandomisation follow-up period in an intention to treat analysis. Secondary outcomes include efficacy, safety, cost-effectiveness and immune reconstitution of aHSCT and the four high-efficacy DMTs.

Ethics and dissemination

The study was approved by the Yorkshire and Humber—Leeds West Research Ethics Committee (20/YH/0061). Participants will provide written informed consent prior to any study specific procedures. The study results will be submitted to a peer-reviewed journal and abstracts will be submitted to relevant national and international conferences.

Trial registration number

ISRCTN88667898.

What might make nurses stay? A protocol for discrete choice experiments to understand NHS nurses preferences at early-career and late-career stages

Por: Ejebu · O.-Z. · Turnbull · J. · Atherton · I. · Rafferty · A. M. · Palmer · B. · Philippou · J. · Prichard · J. · Jamieson · M. · Rolewicz · L. · Williams · M. · Ball · J.
Introduction

Like many countries, England has a national shortage of registered nurses. Employers strive to retain existing staff, to ease supply pressures. Disproportionate numbers of nurses leave the National Health Services (NHS) both early in their careers, and later, as they near retirement age. Research is needed to understand the job preferences of early-career and late-career nurses working in the NHS, so tailored policies can be developed to better retain these two groups.

Methods and analysis

We will collect job preference data for early-career and late-career NHS nurses, respectively using two separate discrete choice experiments (DCEs). Findings from the literature, focus groups, academic experts and stakeholder discussions will be used to identify and select the DCE attributes (ie, job features) and levels. We will generate an orthogonal, fractional factorial design using the experimental software Ngene. The DCEs will be administered through online surveys distributed by the regulator Nursing and Midwifery Council. For each group, we expect to achieve a final sample of 2500 registered NHS nurses working in England. For early-career nurses, eligible participants will be registered nurses who graduated in the preceding 5 years (ie, 2019–2023). Eligible participants for the late-career survey will be registered nurses aged 55 years and above. We will use conditional and mixed logit models to analyse the data. Specifically, study 1 will estimate the job preferences of early-career nurses and the possible trade-offs. Study 2 will estimate the retirement preferences of late-career NHS nurses and the potential trade-offs.

Ethics and dissemination

The research protocol was reviewed and approved by the host research organisation Ethics Committees Research Governance (University of Southampton, number 80610) (https://www.southampton.ac.uk/about/governance/regulations-policies/policies/ethics). The results will be disseminated via conference presentations, publications in peer-reviewed journals and annual reports to key stakeholders, the Department of Health and Social Care, and NHS England/Improvement retention leaders.

Registration details

Registration on OSF http://doi.org/10.17605/OSF.IO/RDN9G.

Characterization and comparison of human and mouse milk cells

by Rose Doerfler, Saigopalakrishna Yerneni, Alexandra Newby, Namit Chaudhary, Ashley Shu, Katherine Fein, Juliana Hofstatter Azambuja, Kathryn A. Whitehead

Recent data has characterized human milk cells with unprecedented detail and provided insight into cell populations. While such analysis of freshly expressed human milk has been possible, studies of cell functionality within the infant have been limited to animal models. One commonly used animal model for milk research is the mouse; however, limited data are available describing the composition of mouse milk. In particular, the maternal cells of mouse milk have not been previously characterized in detail, in part due to the difficulty in collecting sufficient volumes of mouse milk. In this study, we have established a method to collect high volumes of mouse milk, isolate cells, and compare the cell counts and types to human milk. Surprisingly, we found that mouse milk cell density is three orders of magnitude higher than human milk. The cell types present in the milk of mice and humans are similar, broadly consisting of mammary epithelial cells and immune cells. These results provide a basis of comparison for mouse and human milk cells and will inform the most appropriate uses of mouse models for the study of human phenomena.

Development of clinical items to identify dysphagia in patients with dementia—An e‐Delphi study

Abstract

Aim

To identify clinical observable items that can be used to identify dysphagia while observing a typical eating situation.

Design

A three-round e-Delphi survey.

Methods

An expert panel consisting of five nurses, eight speech language therapists and five physicians participated in this three-round e-Delphi survey from November 2022 to January 2023. Round 1 presented the results of a literature research conducted in September 2022 and an open question to the participants. The answers were analysed using the content analysis method. In the following rounds, the results were presented back to the participants with a request to rate them for usefulness. Means, standard deviations, ANOVA and Fisher's exact test were used to demonstrate the panel's opinion, level of agreement, demographic characteristics of the participants as well as differences between the professional groups in regard of the rating of the items. Methods and results are reported in accordance with the ‘Guidance on Conducting and Reporting Delphi Studies’ (CREDES).

Results

The content analysis initially generated 36 items suggested by the expert panel. Seven additional items were incorporated from the literature review. In rounds 2 and 3, a 4-point Likert scale was used to rate each item and to calculate the level of agreement. The predetermined level of agreement exceeded 70% for 23 items.

Conclusion

Based on the expert opinions, it is possible for nurses to identify dysphagia in patients with dementia by using the determined 23 items while observing a typical eating situation.

Patient or Public Contributions

The expert panel contributed to the creation of this study by participating in the Delphi rounds.

Implications for the profession and/or patient care

The 23 items determined in this e-Delphi study enable nurses to make dietary adjustments or consult other members of the multidisciplinary team based on available evidence, enabling complications to be avoided.

Impact

What problem did the study address? This study provides evidence regarding the identification of dysphagia in patients with dementia by nurses.

What were the main findings? Twenty-three items were determined by an expert panel that can be used by nurses to identify dysphagia in patients with dementia while observing a typical eating situation.

Where and on whom will the research have an impact? This research will have an impact on patients with dementia and the nurses caring for them.

Reporting method

Methods and results are reported in accordance with the ‘Guidance on Conducting and Reporting Delphi Studies’ (CREDES) (Jünger et al., 2017), which promotes consistency and quality in conducting Delphi studies.

Mental health nurses' empathy towards consumers with dual diagnosis: A descriptive study

Abstract

Aim

This study aimed to assess mental health nurses' empathy towards consumers with dual diagnosis in Australian mental health settings. The research question was What is mental health nurses' empathy towards consumers with co-existing mental health and drug and alcohol problems?

Design and Methods

A cross-sectional survey was carried out to understand mental health nurses' empathy. The convenience sample included 96 mental health nurses from various mental health settings with experience working with consumers with dual diagnosis. We assessed empathy using the Toronto Empathy Questionnaire. We utilised SPSS™ software to analyse both the descriptive data and multiple-regression.

Results

The mean empathy score was 47.71 (SD 8.28). The analysis of the association between demographic variables and individual subscales showed an association between the clinical setting and empathy (p = .031) and sympathetic physiological arousal (p = .049). The work sector was associated with sympathetic physiological arousal (p = .045) and conspecific altruism (p = .008). Emotional contagion (β = .98, p < .001), emotional comprehension (β = 1.02, p < .001), sympathetic physiological arousal (β = 1.01, p < .001) and conspecific altruism (β = 10.23, p < .001) predicted mental health nurses' empathy.

Conclusions

This study found that most mental health nurses showed empathy towards consumers with dual diagnosis. Mental health nurses who are more empathetic towards their consumers experience emotional contagion. They understand emotions better, show sympathetic physiological responses and exhibit kind behaviour towards consumers.

Implications for the Profession and Patient Care

Further research is required to understand how mental health nurses adapt to consumers' emotional states in different mental health settings. This information can help clinicians make better decisions about care quality for consumers with dual diagnosis.

Impact

This study addressed mental health nurses' empathy towards consumers with dual diagnosis. Mental health nurses showed increased empathy towards consumers with dual diagnosis. The empathy levels vary based on age, clinical setting, work sector and work experience. Mental health nurses' empathy levels were predicted by emotional contagion, emotion comprehension, sympathetic physiological arousal and conspecific altruism. Empathy enhancement among mental health nurses, particularly towards consumers with dual diagnosis, is crucial and should be regarded as a top priority by healthcare leaders and educators.

Reporting Method

Outlined by the Consensus-Based Checklist for Reporting of Survey Studies (CROSS).

Patient or Public Contribution

No Patient or Public Contribution.

Prevalence and clustering of NANDA‐I nursing diagnoses in the pre‐hospital emergency care setting: A retrospective records review study

Abstract

Aim

To determine the prevalence and clustering of NANDA-International nursing diagnoses in patients assisted by pre-hospital emergency teams.

Design

Retrospective descriptive study of electronic record review.

Methods

Episodes recorded during 2019, including at least a nursing diagnosis, were recovered from the electronic health records of a Spanish public emergency agency (N = 28,847). Descriptive statistics were used to characterize the sample and determine prevalence. A two-step cluster analysis was used to group nursing diagnoses. A comparison between clusters in sociodemographic and medical problems was performed. Data were accessed in November 2020.

Results

Risk for falls (00155) (27.3%), Anxiety (00146) (23.2%), Acute pain (00132), Fear (00148) and Ineffective breathing pattern (00032) represented 96.1% of all recorded diagnoses. A six-cluster solution (n = 26.788) was found. Five clusters had a single high-prevalence diagnosis predominance: Risk for falls (00155) in cluster 1, Anxiety (00146) in cluster 2, Fear (00148) in cluster 3, Acute pain (00132) in cluster 4 and Ineffective breathing pattern (00032) in cluster 6. Cluster 5 had several high prevalence diagnoses which co-occurred: Risk for unstable blood glucose level (00179), Ineffective coping (00069), Ineffective health management (00078), Impaired comfort (00214) and Impaired verbal communication (00051).

Conclusion

Five nursing diagnoses accounted for almost the entire prevalence. The identified clusters showed that pre-hospital patients present six patterns of nursing diagnoses. Five clusters were predominated by a predominant nursing diagnosis related to patient safety, coping, comfort, and activity/rest, respectively. The sixth cluster grouped several nursing diagnoses applicable to exacerbations of chronic diseases.

Implications for the profession and/or patient care

Knowing the prevalence and clustering of nursing diagnoses allows a better understanding of the human responses of patients attended by pre-hospital emergency teams and increases the evidence of individualized/standardized care plans in the pre-hospital clinical setting.

Impact

What problem did the study address? There are different models of pre-hospital emergency care services. The use of standardized nursing languages in the pre-hospital setting is not homogeneous. Studies on NANDA-I nursing diagnoses in the pre-hospital context are scarce, and those available are conducted on small samples.

What were the main findings? This paper reports the study with the largest sample among the few published on NANDA-I nursing diagnoses in the pre-hospital care setting. Five nursing diagnoses represented 96.1% of all recorded. These diagnoses were related to patients' safety/protection and coping/stress tolerance. Patients attended by pre-hospital care teams are grouped into six clusters based on the nursing diagnoses, and this classification is independent of the medical conditions the patient suffers.

Where and on whom will the research have an impact?

Knowing the prevalence of nursing diagnoses allows a better understanding of the human responses of patients treated in the pre-hospital setting, increasing the evidence of individualized and standardized care plans for pre-hospital care.

Reporting method

STROBE checklist has been used as a reporting method.

No Patient or Public Contribution

Only patients' records were reviewed without further involvement.

The impact of cineole treatment timing on common cold duration and symptoms: Non-randomized exploratory clinical trial

by Andreas Michalsen, Kim Goldenstein, Peter Kardos, Ludger Klimek, Jürgen Palm, Dajana Parganlija, Johannes Stöckl

Introduction

Common cold (CC) symptoms arise from an inflammatory response treatable with cineole and generally peak within two days, which complicates research implementation. We therefore explored the benefits of early cineole administration with enrolment of participants prior to CC onset.

Methods

Out of 522 adults enrolled in our phase IV, open-label, non-randomized, exploratory clinical trial (EudraCT No. 2020-000860-51), 329 developed a CC and used 200 mg cineole (Soledum®, CNL-1976) t.i.d. for max. 15 (± 2) days. Primary endpoint was burden of disease based on the Wisconsin Upper Respiratory Symptom Survey (WURSS-11).

Results

Comparing three strata based on time to treatment (≤ 12 h, > 12 to ≤ 24 h and > 24 h), earliest treatment resulted in lowest AUC-WURSS (Spearman correlation coefficient of 0.36) and reduced the overall burden of disease by 38% (p Conclusions

Early intervention shows clinical benefits relevant for the effective treatment of CC with cineole.

D-dimer levels to exclude pulmonary embolism and reduce the need for CT angiography in COVID-19 in an outpatient population

by Anita Kovács, Dóra Hantosi, Nikoletta Szabó, Annamária Letoha, Csaba Lengyel, Imre Földesi, Katalin Burián, András Palkó, Dániel Veréb, Zsigmond Tamás Kincses

Objectives

Emerging results indicate that, in COVID-19, thromboembolic complications contribute to the high mortality and morbidity. Previous research showed that the prevalence of pulmonary embolism (PE) is between 25–50% in COVID-19 patients, however, most of these reports are based on data from patients with severe pneumonia, treated in intensive care units.

Materials and methods

We conducted a retrospective, single-center, observational study to estimate the prevalence of PE in COVID-19 patients who underwent CT angiography and to identify the most important predictors.Adult outpatients with COVID-19, who presented at our COVID Outpatient Clinic between 1st and 31st of March in 2021 and underwent CTA examination were included in this study. Multiple linear regression analysis was used to identify predictors of PE in COVID-19 patients. The predictors were: age, gender, disease duration, CT severity index and log-transformed quantitative D-dimer (logQDDIM) value.

Results

843 COVID-19 patients were included into the study. 82.56% (693 patients) of the infected patients had a pulmonary CTA examination and D-dimer levels (mean age: 59.82 years ± 15.66). 7.61% (53 patients) of the patients had PE. 2.02% (14 patients) of the patients had main branch or lobar PE.The multiple regression analysis found that only logQDDIM was a significant predictor. A logQDDIM cut-off value of 0.0169 (1.0171 ug/ml serum D-dimer) predicted PE with 99% sensitivity (p Conclusions

We demonstrated in a large cohort of COVID-19 patients that a cut-off value of QDDIM of 1ug/ml can exclude pulmonary embolism in an outpatient setting, implicating that QDDIM might potentially supersede CTA as a screening approach in COVID-19 outpatient clinics.

Psychometric properties of the Fluoride Hesitancy Identification Tool (FHIT)

by Adam C. Carle, Isabella Pallotto, Todd C. Edwards, Richard Carpiano, Darragh C. Kerr, Donald L. Chi

Introduction

Some caregivers are hesitant about topical fluoride for their children despite evidence that fluoride prevents caries and is safe. Recent work described a five domain model of caregivers’ topical fluoride hesitancy. We developed the Fluoride Hesitancy Identification Tool (FHIT) item pool based on the model. This study sought to evaluate the FHIT’s psychometric properties in an effort to generate a short, simple to score, reliable, and valid tool that measures caregivers’ topical fluoride hesitancy.

Methods

In 2021 and 2022, we conducted an observational, cross-sectional study of caregivers, collecting data from two independent caregiver samples (n1 = 523; n2 = 612). The FHIT item pool included 33 items. We used confirmatory factor analyses (CFA) to examine whether the FHIT items measured five separate domains as hypothesized and to reduce the number of items. We then fit item response theory (IRT) models and computed Cronbach’s alpha for each domain. Last, we examined the construct validity of the FHIT and evaluated scoring approaches.

Results

After dropping 8 items, CFA supported a five factor model of topical fluoride hesitancy, with no cross-loadings (RMSEA = 0.079; SRMR = 0.057; CFI = 0.98; TLI = 0.98). We further reduced the items to four per domain (20 items total). Marginal alphas showed that the item sets provided reliability of ≥0.90 at hesitancy levels at and above average. The domains correlated more strongly with each other and topical fluoride refusal than with other questions on the survey.

Discussion

Our results support the FHIT’s ability to reliably and validly measure five domains of topical fluoride hesitancy using the average score of the four items in each domain.

Global perspectives of determinants influencing HPV vaccine introduction and scale-up in low- and middle-income countries

by Dominique Guillaume, Dur-e-Nayab Waheed, Meike Schleiff, Kirthini Kasi Muralidharan, Alex Vorsters, Rupali J. Limaye

Achieving WHO cervical cancer elimination goals will necessitate efforts to increase HPV vaccine access and coverage in low-and-middle-income countries (LMICs). Although LMICs account for the majority of cervical cancer cases globally, scale-up of HPV vaccine programs and progress toward coverage targets in LMICs has been largely insufficient. Understanding the barriers and facilitators that stakeholders face in the introduction and scale-up of HPV vaccination programs will be pivotal in ensuring that LMICs are equipped to optimize the implementation of HPV vaccination programs. This qualitative study interviewed 13 global stakeholders categorized as either academic partners or global immunization partners to ascertain perspectives regarding factors affecting the introduction and scale-up of HPV vaccination programs in LMICs. Global stakeholders were selected as their perspectives have not been as readily highlighted within the literature despite their key role in HPV vaccination programming. The results of this investigation identified upstream (e.g., financial considerations, vaccine prioritization, global supply, capacity and delivery, and vaccine accessibility, equity, and ethics) and downstream (e.g., vaccine acceptability and hesitancy, communications, advocacy, and social mobilization) determinants that impact program introduction and scale-up and confirmed that strong political commitment and governance are significant in garnering support for HPV vaccines. As LMICs introduce HPV vaccines into their national immunization programs and develop plans for scaling up vaccination efforts, strategic approaches to communications and advocacy will also be needed to successfully meet coverage targets.
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