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Associations between hospital organizational features, person‐centred care and nurse‐sensitive outcomes for persons with dementia in acute care: A systematic literature review

Abstract

Aim(s)

The aim of this systematic literature review was to determine the extent and quality of quantitative evidence regarding associations between hospital organizational features, person-centred care (PCC) and nursing-sensitive outcomes among persons with dementia in the acute care setting.

Design

Systematic review.

Methods

Key terms were utilized to guide searches in four databases. The two reviewers deduplicated articles and came to a consensus for the final sample using inclusion and exclusion criteria.

Data Sources

MEDLINE/OVID, CINHAL, COCHRANE and WEB OF SCIENCE.

Results

There were 10 studies included. PCC was associated with better outcomes for persons with dementia (i.e. decreased restraint use, decreased length of stay, increased involvement with families and the patient, and increased nurse confidence and competence in caring for this population). Of the studies, none explicitly identified an association between nursing-sensitive outcomes, PCC and hospital organizational features in the acute care setting among persons with dementia.

Conclusion

This review highlights a clinically significant gap in knowledge regarding associations between hospital organizational features, PCC and nursing sensitive outcomes. The impact of face-to-face dementia competency training as a standard practice among acute care facilities, the importance of leadership engagement, support and involvement to improve nurse confidence and competence in caring for persons with dementia needs to be explored.

Impact Statement

These findings support future research to understand the relationship between organization features and patient-centred care and how these collectively impact nursing-sensitive outcomes, specifically in persons with dementia in acute care settings.

Examining the relationship between the oral microbiome, alcohol intake and alcohol-comorbid neuropsychological disorders: protocol for a scoping review

Por: Maki · K. A. · Crayton · C. B. · Butera · G. · Wallen · G. R.
Introduction

Heavy alcohol use and alcohol use disorder (AUD) continues to rise as a public health problem and increases the risk for disease. Elevated rates of anxiety, depression, sleep disruption and stress are associated with alcohol use. Symptoms may progress to diagnosed neurophysiological conditions and increase risk for relapse if abstinence is attempted. Research on mechanisms connecting the gastrointestinal microbiome to neuropsychological disorders through the gut-brain axis is well-established. Less is known how the oral microbiome and oral microbial-associated biomarkers may signal to the brain. Therefore, a synthesis of research studying relationships between alcohol intake, alcohol-associated neurophysiological symptoms and the oral microbiome is needed to understand the state of the current science. In this paper, we outline our protocol to collect, evaluate and synthesise research focused on associations between alcohol intake and AUD-related neuropsychological disorders with the oral microbiome.

Methods and analysis

The search strategy was developed and will be executed in collaboration with a medical research librarian. Studies will be screened by two independent investigators according to the aim of the scoping review, along with the outlined exclusion and inclusion criteria. After screening, data will be extracted and synthesised from the included papers according to predefined demographic, clinical and microbiome methodology metrics.

Ethics and dissemination

A scoping review of primary sources is needed to synthesise the data on relationships between alcohol use, neuropsychological conditions associated with AUD and the oral microbiome. The proposed scoping review is based on the data from publicly available databases and does not require ethical approval. We expect the results of this synthesis will identify gaps in the growing literature and highlight potential mechanisms linking the oral-brain axis to addiction and other associated neuropsychological conditions. The study findings and results will be disseminated through journals and conferences related to psychology, neuroscience, dentistry and the microbiome.

What impact has the Centre of Research Excellence in Digestive Health made in the field of gastrointestinal health in Australia and internationally? Study protocol for impact evaluation using the FAIT framework

Por: Koloski · N. · Duncanson · K. · Ramanathan · S. A. · Rao · M. · Holtmann · G. · Talley · N. J.
Introduction

The need for public research funding to be more accountable and demonstrate impact beyond typical academic outputs is increasing. This is particularly challenging and the science behind this form of research is in its infancy when applied to collaborative research funding such as that provided by the Australian National Health and Medical Research Council to the Centre for Research Excellence in Digestive Health (CRE-DH).

Methods and analysis

In this paper, we describe the protocol for applying the Framework to Assess the Impact from Translational health research to the CRE-DH. The study design involves a five-stage sequential mixed-method approach. In phase I, we developed an impact programme logic model to map the pathway to impact and establish key domains of benefit such as knowledge advancement, capacity building, clinical implementation, policy and legislation, community and economic impacts. In phase 2, we have identified and selected appropriate, measurable and timely impact indicators for each of these domains and established a data plan to capture the necessary data. Phase 3 will develop a model for cost–consequence analysis and identification of relevant data for microcosting and valuation of consequences. In phase 4, we will determine selected case studies to include in the narrative whereas phase 5 involves collation, data analysis and completion of the reporting of impact.

We expect this impact evaluation to comprehensively describe the contribution of the CRE-DH for intentional activity over the CRE-DH lifespan and beyond to improve outcomes for people suffering with chronic and debilitating digestive disorders.

Ethics and dissemination

This impact evaluation study has been registered with the Hunter New England Human Research Ethics Committee as project 2024/PID00336 and ethics application 2024/ETH00290. Results of this study will be disseminated via medical conferences, peer-reviewed publications, policy submissions, direct communication with relevant stakeholders, media and social media channels such as X (formely Twitter).

Predictors of recovery time from severe community-acquired pneumonia among paediatrics patients in selected hospitals in Addis Ababa, Ethiopia: an institution-based retrospective cohort study

Por: Sinishaw · K. M. · Sebsbie · G. · Kebede · M. A.
Objective

Severe community-acquired pneumonia (SCAP) is a significant cause of morbidity worldwide and a major cause of morbidity and mortality in developing countries. Ethiopia ranks 6th out of 15 countries with the highest mortality rate due to pneumonia in children under 5 years of age. The aim of this study was to determine the recovery time from SCAP and factors in paediatric patients in selected hospitals in Addis Ababa.

Design, participants and setting

A retrospective cohort study was conducted among 407 randomly selected paediatric patients admitted with SCAP in Addis Ababa public hospitals from 1 January 2018 to 31 December 2020.

Primary and secondary outcomes

Recovery time and recovery rate from SCAP were estimated using Kaplan-Meier and simple frequency statistics, respectively, and the adjusted HR with a 95% CI was used to identify associated factors for recovery.

Results

91.5% (95% CI: 88.3% to 94.1%) of children recovered from SCAP with an overall recovery rate of 11.5 (95% CI: 10.37 to 12.76) per 100 person-day observation, and the median recovery time was 6 days. In the multivariable analysis, older age and the absence of comorbidities were protective factors for early recovery, while stunting and late utilisation of medical care were risk factors.

Conclusion

The median recovery time after SCAP was very long compared with the optimal recovery time of 3 days given in the British Thoracic Society guidelines. Older age and absence of comorbidities were found to shorten recovery time, whereas stunting and late initiation of treatment delayed recovery. Therefore, measures that increase the recovery rate and shorten the recovery time, such as primary prevention to eliminate malnutrition and increase the utilisation of medical care in the community, should be strengthened, and health workers should focus on the early detection and treatment of comorbid diseases.

Investigation of divergent thinking among surgeons and surgeon trainees in Canada (IDEAS): a mixed-methods study

Por: Thabane · A. · McKechnie · T. · Arora · V. · Calic · G. · Busse · J. W. · Sonnadara · R. · Bhandari · M.
Objective

To assess the creative potential of surgeons and surgeon trainees, as measured by divergent thinking. The secondary objectives were to identify factors associated with divergent thinking, assess confidence in creative problem-solving and the perceived effect of surgical training on creative potential, and explore the value of creativity in surgery.

Design

We used a mixed-methods design, conducting a survey of divergent thinking ability using a validated questionnaire followed by two semi-structured interviews with top-scoring participants.

Participants & setting

Surgeons and surgeon trainees in the Department of Surgery at McMaster University.

Outcomes

The primary outcome was divergent thinking, assessed with the Abbreviated Torrance Test for Adults. Participants also self-assessed their confidence in creative problem-solving and the effect of surgical training on their creative potential. We performed descriptive analyses and multivariable linear regression to identify factors associated with divergent thinking. We conducted a thematic analysis of the interview responses.

Results

82 surgeons and surgeon trainees were surveyed; 43 were junior trainees and 28 were senior trainees. General surgery, orthopaedic surgery and plastic surgery represented 71.9% of the participants. The median participant age was 28 years (range 24–73), 51.2% of whom were female. Participants demonstrated levels of divergent thinking that were higher but not meaningfully different from the adult norm (62.39 (95% CI 61.25, 63.53), p

Conclusions

The divergent thinking ability among surgeons and surgeon trainees was not meaningfully different from the adult normative score; however, their ability to generate original ideas was below average.

Cohort profile: The Health, Food, Purchases and Lifestyle (SMIL) cohort - a Danish open cohort

Por: Sorensen · K. K. · Andersen · M. P. · Moller · F. T. · Eves · C. · Junker · T. G. · Zareini · B. · Torp-Pedersen · C.
Purpose

The Health, Food, Purchases and Lifestyle (SMIL) cohort is a prospective open Danish cohort that collects electronic consumer purchase data, which can be linked to Danish nationwide administrative health and social registries. This paper provides an overview of the cohort’s baseline characteristics and marginal differences in the monetary percentage spent on food groups by sex, age and hour of the day.

Participants

As of 31 December 2022, the cohort included 11 214 users of a smartphone-based receipt collection application who consented to share their unique identification number for linkage to registries in Denmark. In 2022, the composition of the cohort was as follows: 62% were men while 24% were aged 45–55. The cohort had a median of 63 (IQR 26–116) unique shopping trips. The cohort included participants with a range of health statuses. Notably, 21% of participants had a history of cardiovascular disease and 8% had diabetes before donating receipts.

Findings to date

The feasibility of translating consumer purchase data to operationalisable food groups and merging with registers has been demonstrated. We further demonstrated differences in marginal distributions which revealed disparities in the amount of money spent on various food groups by sex and age, as well as systematic variations by the hour of the day. For example, men under 30 spent 8.2% of their total reported expenditure on sugary drinks, while women under 30 spent 6.5%, men over 30 spent 4.3% and women over 30 spent 3.9%.

Future plans

The SMIL cohort is characterised by its dynamic, continuously updated database, offering an opportunity to explore the relationship between diet and disease without the limitations of self-reported data. Currently encompassing data from 2018 to 2022, data collection is set to continue. We expect data collection to continue for many years and we are taking several initiatives to increase the cohort.

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.

SCALE-UP II: protocol for a pragmatic randomised trial examining population health management interventions to increase the uptake of at-home COVID-19 testing in community health centres

Por: Del Fiol · G. · Orleans · B. · Kuzmenko · T. V. · Chipman · J. · Greene · T. · Martinez · A. · Wirth · J. · Meads · R. · Kaphingst · K. K. · Gibson · B. · Kawamoto · K. · King · A. J. · Siaperas · T. · Hughes · S. · Pruhs · A. · Pariera Dinkins · C. · Lam · C. Y. · Pierce · J. H. · Benson
Introduction

SCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs).

Methods and analysis

The trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2x2x2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2x2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors.

Ethics and dissemination

The protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications.

Trial registration number

ClinicalTrials.gov: NCT05533918 and NCT05533359.

Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol

Por: Grant · S. J. · Kay · S. · Lacey · J. · Kumar · S. · Kerin-Ayres · K. · Stehn · J. · Gonzalez · M. · Templeton · S. · Heller · G. · Cockburn · J. · Wahlroos · S. · Malalasekera · A. · Mak · C. · Graham · S.
Introduction

Neoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high risk, luminal B breast cancer. Side effects of neoadjuvant therapy, such as fatigue, cardiotoxicity, neurotoxicity, anxiety, insomnia, vasomotor symptoms, gastrointestinal disturbance as well as a raft of immune-related adverse events, may impact treatment tolerance, long-term outcomes, and quality of life. Providing early supportive care prior to surgery (typically termed ‘prehabilitation’) may mitigate these side effects and improve quality of life.

During our codesign of the intervention, consumers and healthcare professionals expressed desire for a programme that ‘packaged’ care, was easy to access, and was embedded in their care pathway. We hypothesise that a multimodal supportive care programme including exercise and complementary therapies, underpinned by behavioural change theory will improve self-efficacy, quality of life, readiness for surgery and any additional treatment for women with breast cancer. We seek to explore cardiometabolic, residual cancer burden and surgical outcomes, along with chemotherapy completion (relative dose intensity). This article describes the protocol for a feasibility study of a multimodal prehabilitation programme.

Methods and analysis

This is a prospective, mixed-method, feasibility study of a multi-modal programme in a hospital setting for 20–30 women with breast cancer receiving neoadjuvant therapy. Primary outcomes are recruitment rate, retention rate, adherence and acceptability. Secondary outcomes include patient reported outcome measures (PROMs), surgical outcomes, length of stay, satisfaction with surgery, chemotherapy completion rates, changes in metabolic markers and adverse events. Interviews and focus groups to understand the experience with prehabilitation and different factors that may affect feasibility of the intervention . The output of this study will be a codesigned, evidence-informed intervention assessed for feasibility and acceptability by women with breast cancer and the healthcare professionals that care for them.

Ethics and dissemination

The study received ethics approval from the St Vincents Hospital HREC (HREC/2021/ETH12198). Trial results will be communicated to participants, healthcare professionals, and the public via publication and conferences.

Trial registration number

ACTRN12622000584730.

Decentralising chronic disease management in sub-Saharan Africa: a protocol for the qualitative process evaluation of community-based integrated management of HIV, diabetes and hypertension in Tanzania and Uganda

Por: Van Hout · M.-C. · Akugizibwe · M. · Shayo · E. H. · Namulundu · M. · Kasujja · F. X. · Namakoola · I. · Birungi · J. · Okebe · J. · Murdoch · J. · Mfinanga · S. G. · Jaffar · S.
Introduction

Sub-Saharan Africa continues to experience a syndemic of HIV and non-communicable diseases (NCDs). Vertical (stand-alone) HIV programming has provided high-quality care in the region, with almost 80% of people living with HIV in regular care and 90% virally suppressed. While integrated health education and concurrent management of HIV, hypertension and diabetes are being scaled up in clinics, innovative, more efficient and cost-effective interventions that include decentralisation into the community are required to respond to the increased burden of comorbid HIV/NCD disease.

Methods and analysis

This protocol describes procedures for a process evaluation running concurrently with a pragmatic cluster-randomised trial (INTE-COMM) in Tanzania and Uganda that will compare community-based integrated care (HIV, diabetes and hypertension) with standard facility-based integrated care. The INTE-COMM intervention will manage multiple conditions (HIV, hypertension and diabetes) in the community via health monitoring and adherence/lifestyle advice (medicine, diet and exercise) provided by community nurses and trained lay workers, as well as the devolvement of NCD drug dispensing to the community level. Based on Bronfenbrenner’s ecological systems theory, the process evaluation will use qualitative methods to investigate sociostructural factors shaping care delivery and outcomes in up to 10 standard care facilities and/or intervention community sites with linked healthcare facilities. Multistakeholder interviews (patients, community health workers and volunteers, healthcare providers, policymakers, clinical researchers and international and non-governmental organisations), focus group discussions (community leaders and members) and non-participant observations (community meetings and drug dispensing) will explore implementation from diverse perspectives at three timepoints in the trial implementation. Iterative sampling and analysis, moving between data collection points and data analysis to test emerging theories, will continue until saturation is reached. This process of analytic reflexivity and triangulation across methods and sources will provide findings to explain the main trial findings and offer clear directions for future efforts to sustain and scale up community-integrated care for HIV, diabetes and hypertension.

Ethics and dissemination

The protocol has been approved by the University College of London (UK), the London School of Hygiene and Tropical Medicine Ethics Committee (UK), the Uganda National Council for Science and Technology and the Uganda Virus Research Institute Research and Ethics Committee (Uganda) and the Medical Research Coordinating Committee of the National Institute for Medical Research (Tanzania). The University College of London is the trial sponsor. Dissemination of findings will be done through journal publications and stakeholder meetings (with study participants, healthcare providers, policymakers and other stakeholders), local and international conferences, policy briefs, peer-reviewed journal articles and publications.

Trial registration number

ISRCTN15319595.

Co-creating a new Charter for equitable and inclusive co-creation: insights from an international forum of academic and lived experience experts

Por: Mulvale · G. · Moll · S. · Phoenix · M. · Buettgen · A. · Freeman · B. · Murray-Leung · L. · Micsinszki · S. K. · Mulalu · L. · Vrzovski · A. · Foisy · C.
Background

Co-creation approaches, such as co-design and co-production, aspire to power-sharing and collaboration between service providers and service users, recognising the specific insights each group can provide to improve health and other public services. However, an intentional focus on equity-based approaches grounded in lived experience and epistemic justice is required considering entrenched structural inequities between service-users and service-providers in public and institutional spaces where co-creation happens.

Objectives

This paper presents a Charter of tenets and principles to foster a new era of ‘Equity-based Co-Creation’ (EqCC).

Methods

The Charter is based on themes heard during an International Forum held in August 2022 in Ontario, Canada, where 48 lived experience experts and researchers were purposively invited to deliberate challenges and opportunities in advancing equity in the co-creation field.

Results

The Charter’s seven tenets—honouring worldviews, acknowledging ongoing and historical harms, operationalising inclusivity, establishing safer and brave spaces, valuing lived experiences, ‘being with’ and fostering trust, and cultivating an EqCC heartset/mindset—aim to promote intentional inclusion of participants with intersecting social positions and differing historic oppressions. This means honouring and foregrounding lived experiences of service users and communities experiencing ongoing structural oppression and socio-political alienation—Black, Indigenous and people of colour; disabled, Mad and Deaf communities, women, 2S/LGBTQIA+ communities, people perceived to be mentally ill and other minoritised groups—to address epistemic injustice in co-creation methodologies and practice, thereby providing opportunities to begin to dismantle intersecting systems of oppression and structural violence.

Conclusions

Each Charter tenet speaks to a multilayered, multidimensional process that is foundational to shifting paradigms about redesigning our health and social systems and changing our relational practices. Readers are encouraged to share their reactions to the Charter, their experiences implementing it in their own work, and to participate in a growing international EqCC community of practice.

Barriers and enablers of quality high-acuity neonatal care in sub-Saharan Africa: protocol for a synthesis of qualitative evidence

Por: Mersha · A. · Demissie · A. · Nemera · G.
Introduction

Neonatal intensive care unit (NICU) in sub-Saharan Africa face limited resources and systemic challenges, resulting in poorer quality care, higher infant mortality, and dissatisfaction among both patients and healthcare workers. This review aims to bridge the knowledge gap by identifying and analysing the key barriers and enablers affecting quality care, informing interventions to improve patient outcomes and overall NICU effectiveness in this critical region.

Methods and analysis

This systematic review will search and gather data from a variety of databases, including JBI Database, Cochrane Database, MEDLINE/PubMed, CINAHL/EBSCO, EMBASE, PEDro, POPLINE, Proquest, OpenGrey (SIGLE), Google Scholar, Google, APA PsycINFO, Web of Science, Scopus and HINARI. The review will also include unpublished studies and grey literature from a variety of sources. This review will only include qualitative and mixed-methods studies that explore the barriers and enablers of quality care for high-acuity neonates using qualitative data collection and analysis methods. The Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Qualitative Research will be used by two independent reviewers to critically appraise the eligible studies. Any disagreements that arise will be resolved through discussion. Qualitative research findings will be pooled using the meta-aggregation approach in QARI software, where possible. Only unequivocal and credible findings will be included in the synthesis. If textual pooling is not possible, the findings will be presented in narrative form.

Ethics and dissemination

This systematic review does not require ethical clearance, and the findings will be disseminated to relevant stakeholders to ensure the widest possible outreach and impact.

PROSPERO registration number

CRD42023473134.

Experiences of the clinical academic pathway: a qualitative study in Greater Manchester to improve the opportunities of minoritised clinical academics

Por: Lin · C.-Y. · Greco · C. · Radhakrishnan · H. · Finn · G. M. · Cowen · R. L. · Gardiner · N. J.
Objectives

The aim of this study was to explore the barriers and facilitators faced by clinical academics (CAs) in the Greater Manchester region, with particular attention to the experiences of minoritised groups.

Design

A qualitative study using semistructured interviews and focus groups was conducted. A reflexive thematic analysis was applied to identify key themes.

Setting

University of Manchester and National Health Service Trusts in the Greater Manchester region.

Participants

The sample of this study was composed of 43 participants, including CAs, senior stakeholders, clinicians and medical and dental students.

Results

Six themes were identified. CAs face several barriers and facilitators, some of which—(1) funding insecurity and (2) high workload between the clinic and academia—are common to all the CAs. Other barriers, including (3) discrimination that translates into struggles with self-worth and feeling of not belonging, (4) being or being perceived as foreign and (5) unequal distribution of care duties, particularly affect people from minoritised groups. In contrast, (6) mentorship was commonly identified as one of the most important facilitators.

Conclusions

Cultural and structural interventions are needed, such as introducing financial support for early career CAs and intercalating healthcare students to promote wider social and cultural change and increase the feelings of belonging and representation across the entire CA pipeline.

Perceptions and experiences of paramedics managing people with non-traumatic low back pain: a qualitative study of Australian paramedics

Por: Vella · S. P. · Simpson · P. · Bendall · J. C. · Pickles · K. · Copp · T. · Swain · M. S. · Maher · C. G. · Machado · G. C.
Background

Paramedics are often first providers of care to patients experiencing non-traumatic low back pain (LBP), though their perspectives and experiences with managing these cases remain unclear.

Objectives

This study explored paramedic views of the management of non-traumatic LBP including their role and experience with LBP management, barriers to referral and awareness of ambulance service guidelines.

Design

Qualitative study using semistructured interviews conducted between January and April 2023.

Setting

New South Wales Ambulance service.

Participants

A purposive sample of 30 paramedics of different specialities employed by New South Wales Ambulance were recruited.

Results

Paramedic accounts demonstrated the complexity, challenge, frustration and reward associated with managing non-traumatic LBP. Paramedics perceived that their primary role focused on the assessment of LBP, and that calls to ambulance services were often driven by misconceptions surrounding the management of LBP, and a person’s pain severity. Access to health services, patient factors, defensive medicine, paramedic training and education and knowledge of guidelines influenced paramedic management of LBP.

Conclusion

Paramedics often provide care to non-traumatic LBP cases yet depending on the type of paramedic speciality find these cases to be frustrating, challenging or rewarding to manage due to barriers to referral including access to health services, location, patient factors and uncertainty relating to litigation. Future research should explore patient perspectives towards ambulance service use for the management of their LBP.

REKOVER study protocol: a pRospective patient treatment rEgistry of tramadol and dexKetoprofen trometamol oral fixed-dose combination (SKUDEXA) in mOderate to seVere acutE pain in Real-world setting in Asia

Por: Ho · K. Y. · Gyanwali · B. · Dimayuga · C. · Eufemio · E. M. · Bernardo · E. · Raju · G. · Chong · K. W. · Waithayayothin · K. · Ona · L. · Castro · M. A. L. · Sawaddiruk · P. · Salvador · R. C. · Roohi · S. A. · Tangwiwat · S. · Wilairatana · V. · Oon · Z. H. · Gupta · A. · Nagrale · D.
Introduction

Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.

Methods and analysis

REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18–80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.

Ethics and dissemination

The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.

Evidence-informed and consensus-based statements about SAFEty of Physical Agent Modalities Practice in physiotherapy and rehabilitation medicine (SAFE PAMP): a national Delphi of healthcare scientific societies

Por: Gianola · S. · Bargeri · S. · Pellicciari · L. · Gambazza · S. · Rossettini · G. · Fulvio · A. · Genovese · V. · Benedini · M. · Proverbio · E. · Cecchetto · S. · Castellini · G. · Turolla · A. · SAFE PAMP Collaborators · Torresetti · Masturzo · Berliri · Roselli · Vercelli · Scorcu
Objective

A shared consensus on the safety about physical agent modalities (PAMs) practice in physiotherapy and rehabilitation is lacking. We aimed to develop evidence-informed and consensus-based statements about the safety of PAMs.

Study design and setting

A RAND-modified Delphi Rounds’ survey was used to reach a consensus. We established a steering committee of the Italian Association of Physiotherapy (Associazione Italiana di Fisioterapia) to identify areas and questions for developing statements about the safety of the most commonly used PAMs in physiotherapy and rehabilitation. We invited 28 National Scientific and Technical Societies, including forensics and lay members, as a multidisciplinary and multiprofessional panel of experts to evaluate the nine proposed statements and formulate additional inputs. The level of agreement was measured using a 9-point Likert scale, with consensus in the Delphi Rounds assessed using the rating proportion with a threshold of 75%.

Results

Overall, 17 (61%) out of 28 scientific and technical societies participated, involving their most representative members. The panel of experts mainly consisted of clinicians (88%) with expertise in musculoskeletal (47%), pelvic floor (24%), neurological (18%) and lymphatic (6%) disorders with a median experience of 30 years (IQR=17–36). Two Delphi rounds were necessary to reach a consensus. The final approved criteria list comprised nine statements about the safety of nine PAMs (ie, electrical stimulation neuromodulation, extracorporeal shock wave therapy, laser therapy, electromagnetic therapy, diathermy, hot thermal agents, cryotherapy and therapeutic ultrasound) in adult patients with a general note about populations subgroups.

Conclusions

The resulting consensus-based statements inform patients, healthcare professionals and policy-makers regarding the safe application of PAMs in physiotherapy and rehabilitation practice. Future research is needed to extend this consensus on paediatric and frail populations, such as immunocompromised patients.

Finerenone cardiovascular and kidney outcomes by age and sex: FIDELITY post hoc analysis of two phase 3, multicentre, double-blind trials

Por: Bansal · S. · Canziani · M. E. F. · Birne · R. · Anker · S. D. · Bakris · G. L. · Filippatos · G. · Rossing · P. · Ruilope · L. M. · Farjat · A. E. · Kolkhof · P. · Lage · A. · Brinker · M. · Pitt · B.
Objectives

This study aimed to evaluate the efficacy and safety of finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, on cardiovascular and kidney outcomes by age and/or sex.

Design

FIDELITY post hoc analysis; median follow-up of 3 years.

Setting

FIDELITY: a prespecified analysis of the FIDELIO-DKD and FIGARO-DKD trials.

Participants

Adults with type 2 diabetes and chronic kidney disease receiving optimised renin–angiotensin system inhibitors (N=13 026).

Interventions

Randomised 1:1; finerenone or placebo.

Primary and secondary outcome measures

Cardiovascular (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure (HHF)) and kidney (kidney failure, sustained ≥57% estimated glomerular filtration rate (eGFR) decline or renal death) composite outcomes.

Results

Mean age was 64.8 years; 45.2%, 40.1% and 14.7% were aged interaction=0.42) and sex categories (HR 0.86 (95% CI 0.77 to 0.96) (male), HR 0.89 (95% CI 0.35 to 2.27) (premenopausal female), HR 0.87 (95% CI 0.73 to 1.05) (postmenopausal female); Pinteraction=0.99). Effects on HHF reduction were not modified by age (Pinteraction=0.70) but appeared more pronounced in males (Pinteraction=0.02). Kidney events were reduced with finerenone versus placebo in age groups interaction=0.51). In sex subgroups, finerenone consistently reduced kidney events (Pinteraction=0.85). Finerenone reduced albuminuria and eGFR decline regardless of age and sex. Hyperkalaemia increased with finerenone, but discontinuation rates were

Conclusions

Finerenone improved cardiovascular and kidney composite outcomes with no significant heterogeneity between age and sex subgroups; however, the effect on HHF appeared more pronounced in males. Finerenone demonstrated a similar safety profile across age and sex subgroups.

Trial registration numbers

NCT02540993, NCT02545049.

Exploring the pharmacists role in optimising antithrombotic therapy in primary care: a qualitative study

Por: van Paassen · J. G. · Tan · J. P. · Deneer · V. H. M. · Bouvy · M. L.
Objective

In antithrombotic therapy, the balance between efficacy and safety is delicate, which makes it challenging for healthcare professionals, including pharmacists, to optimise therapy. Pharmacists may play an important role in optimising antithrombotic therapy, but especially in primary care, this role has not been elucidated. Here, we study how community pharmacists (pharmacists in primary care) perceive their current and future role in antithrombotic therapy.

Design

We conducted a qualitative study using semi-structured interviews. The interview protocol and subsequent analysis were based on the Theoretical Domains Framework, and the findings were interpreted with the Capability Opportunity Motivation – Behaviour System.

Setting and participants

The interview participants were community pharmacists, located across the Netherlands, from the Utrecht Pharmacy Practice network for Education and Research.

Results

We interviewed 16 community pharmacists between February and August 2021 and identified several major themes which were important for the pharmacist’s role in antithrombotic therapy. Pharmacists felt responsible for the outcome of antithrombotic treatment and intended to invest in their role in antithrombotic therapy. Pharmacists did, however, experience barriers to their role in antithrombotic therapy, like a lack of access to clinical information such as the indication of antithrombotic treatment and a lack of specific knowledge on this treatment.

Conclusion

Community pharmacists perceive a role for themselves in antithrombotic therapy. To fulfil this role, several preconditions must be met.

What Matters to Aboriginal and Torres Strait Islander Youth (WM2Y): a study protocol to develop a national youth well-being measure

Por: Garvey · G. · Howard · K. · Garvey · D. · Dickson · M. · Howell · M. · Butler · T. L. · Cadet-James · Y. · Cunningham · J. · Bainbridge · R. · McGorry · P. · Williamson · A. · Anderson · K. M.
Introduction

Adolescents face challenges associated with unprecedented environmental, social and technological changes. The impacts of colonisation, intergenerational trauma, racism and socioeconomic disadvantage intensify these challenges for many Aboriginal and Torres Strait Islander adolescents. However, Aboriginal and Torres Strait Islander adolescents also have cultural, spiritual, family and community capital that fosters their well-being.

To date, little research has focused on understanding and appropriately measuring the well-being of Aboriginal and Torres Strait Islander adolescents, a pivotal factor in informing and guiding programmes and interventions that support them. This study will identify the domains of well-being and develop a new preference-based well-being measure based on the values and preferences of Aboriginal and Torres Strait Islander youth (aged 12–17 years).

Methods and analysis

This project will be conducted across three research phases: (1) qualitative exploration of well-being using PhotoYarning and yarns with adult mentors to develop candidate items; (2) Think Aloud study, quantitative survey, psychometric analysis, validity testing of candidate items and finalisation of the descriptive system; and (3) scoring development using a quantitative preference-based approach. A multinomial (conditional) logit framework will be used to analyse responses and generate a scoring algorithm for the new preference-based well-being measure.

Ethics and dissemination

Ethics approvals have been obtained from: the Human Research Ethics Committees for each state and territory where data are being collected, the institutions where the research is being conducted and from the relevant Departments of Education. The new well-being measure will have wide applicability and can be used in assessing the effectiveness of programmes and services. This new national measure will ensure benefit and positive impact through the ability to identify and measure the aspects of well-being important to and valued by Aboriginal and Torres Strait Islander youth. Results will be published in international peer-reviewed journals and presented at conferences, and summaries will be provided to the study partner organisations and other relevant organisations.

Talking in primary care (TIP): protocol for a cluster-randomised controlled trial in UK primary care to assess clinical and cost-effectiveness of communication skills e-learning for practitioners on patients musculoskeletal pain and enablement

Por: Bishop · F. L. · Cross · N. · Dewar-Haggart · R. · Teasdale · E. · Herbert · A. · Robinson · M. E. · Ridd · M. J. · Mallen · C. · Clarson · L. · Bostock · J. · Becque · T. · Stuart · B. · Garfield · K. · Morrison · L. · Pollet · S. · Vennik · J. · Atherton · H. · Howick · J. · Leydon · G. M
Introduction

Effective communication can help optimise healthcare interactions and patient outcomes. However, few interventions have been tested clinically, subjected to cost-effectiveness analysis or are sufficiently brief and well-described for implementation in primary care. This paper presents the protocol for determining the effectiveness and cost-effectiveness of a rigorously developed brief eLearning tool, EMPathicO, among patients with and without musculoskeletal pain.

Methods and analysis

A cluster randomised controlled trial in general practitioner (GP) surgeries in England and Wales serving patients from diverse geographic, socioeconomic and ethnic backgrounds. GP surgeries are randomised (1:1) to receive EMPathicO e-learning immediately, or at trial end. Eligible practitioners (eg, GPs, physiotherapists and nurse practitioners) are involved in managing primary care patients with musculoskeletal pain. Patient recruitment is managed by practice staff and researchers. Target recruitment is 840 adults with and 840 without musculoskeletal pain consulting face-to-face, by telephone or video. Patients complete web-based questionnaires at preconsultation baseline, 1 week and 1, 3 and 6 months later. There are two patient-reported primary outcomes: pain intensity and patient enablement. Cost-effectiveness is considered from the National Health Service and societal perspectives. Secondary and process measures include practitioner patterns of use of EMPathicO, practitioner-reported self-efficacy and intentions, patient-reported symptom severity, quality of life, satisfaction, perceptions of practitioner empathy and optimism, treatment expectancies, anxiety, depression and continuity of care. Purposive subsamples of patients, practitioners and practice staff take part in up to two qualitative, semistructured interviews.

Ethics approval and dissemination

Approved by the South Central Hampshire B Research Ethics Committee on 1 July 2022 and the Health Research Authority and Health and Care Research Wales on 6 July 2022 (REC reference 22/SC/0145; IRAS project ID 312208). Results will be disseminated via peer-reviewed academic publications, conference presentations and patient and practitioner outlets. If successful, EMPathicO could quickly be made available at a low cost to primary care practices across the country.

Trial registration number

ISRCTN18010240.

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