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Does a participatory live music practice support nurses to deliver compassionate care to hospitalised patients? A qualitative study

Abstract

Aim

To gain more insight into how nurses experience a participatory live music practice in relation to their ability to deliver compassionate care to medically hospitalised patients.

Design

Qualitative interpretive design.

Methods

Sixteen nurses participating in a live music practice with patients were interviewed using in-depth interviews with open-ended questions. Audio recordings were transcribed verbatim and subsequently coded. Theory-driven inductive and deductive approaches were applied in thematic data analysis.

Results

We identified four themes: (1) Nurses' empathy and compassion; (2) The caring nurse–patient relationship; (3) Person-centred approaches to care and (4) Nurses' subjective wellbeing. By observing patients' reactions to the music, nurses described that they obtained a deeper insight and understanding of patients' emotional wellbeing. These observations led to increased feelings of compassion in patient contact and stimulated informal communication between nurses and patients through a sense of shared humanity. According to nurses, these aspects positively affected collaboration with patients in delivering care and stimulated them to pursue person-centred approaches to care. Participating in the live music practice also positively affected nurses' wellbeing, enhanced relaxation and created an ambiance in which compassion could be expressed.

Conclusion

A live music practice can positively contribute to the delivery of compassionate care by providing meaningful shared moments that increase feelings of empathy and compassion and strengthen the caring relationship.

Implications for the profession

Offering a live music practice at the ward and bedside offers a unique possibility to enhance engagement in person-centred, compassionate care.

Impact

While compassion and compassionate care are essential component of nursing, nurses often experience multiple barriers to its provision in daily practice. An innovative way to stimulate compassionate care is through the participation of nurses and patients in a live music practice, providing a meaningful moment shared between them. This stimulates feelings of shared humanity and bonding in the caring relationship.

Reporting Method

The COnsolidated criteria for REporting Qualitative research (COREQ). No Patient or Public Contribution.

Patient‐related decisional regret: An evolutionary concept analysis

Abstract

Background

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

Aim(s)

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

Design

A concept analysis.

Methods

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

Results

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

Conclusion

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

No Patient or Public Contribution

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

Barriers and facilitators in self‐care and management of chronic kidney disease in dialysis patients: A systematic review of qualitative studies

Abstract

Aim

To identify and synthesise qualitative studies on barriers and facilitators perceived by dialysis patients in relation to self-care and disease management.

Design

Systematic review of qualitative studies.

Data Sources

Qualitative study articles were extracted from PUBMED, MEDLINE, COCHRANE, WEB OF SCIENCE (WOS), CINAHL PsycINFO and EMBASE and electronic journals of the Spanish Society of Nephrology and Spanish Society of Nephrological Nursing until May 2022. Studies on barriers and/or facilitators affecting self-care and disease management expressed by people undergoing haemodialysis or peritoneal dialysis were included.

Review Methods

The SPICE (Setting, Perspective, Intervention, Comparison and Evaluation) strategy was used to develop issues and subissues through the thematic synthesis of the qualitative findings. GRADE-CERQual was used to evaluate the articles.

Results

From 172 articles, 15 qualitative articles about barriers and facilitators perceived by patients concerning self-care and disease management were finally included. Identified eight facilitators and four barriers.

Conclusion

Patients perceived a significant number of barriers and facilitators. It is possible to identify which aspects facilitate self-management of their disease and to understand that the processes are individualised. This is why therapeutic strategies should be designed to foster the participation and empowerment of the person in the management of the disease.

Implications for the profession and/or patient care

Identifying the barriers and facilitators concerning the management of chronic kidney disease furnishes us with knowledge for individualised clinical practice and improved care processes.

Impact

This review is the first to synthesise barriers and facilitators in haemodialysis patients about the management of their disease and treatment. The results enable the proposal of improvements in the training of healthcare personnel, clinical practice guidelines and action protocols to improve the daily life and management of the disease by patients.

No patient or public contribution due to this is a systematic review.

Genetic polymorphisms affecting telomere length and their association with cardiovascular disease in the Heinz-Nixdorf-Recall study

by Nico Tannemann, Raimund Erbel, Markus M. Nöthen, Karl-Heinz Jöckel, Sonali Pechlivanis

Short telomeres are associated with cardiovascular disease (CVD). We aimed to investigate, if genetically determined telomere-length effects CVD-risk in the Heinz-Nixdorf-Recall study (HNRS) population. We selected 14 single-nucleotide polymorphisms (SNPs) associated with telomere-length (p−8) from the literature and after exclusion 9 SNPs were included in the analyses. Additionally, a genetic risk score (GRS) using these 9 SNPs was calculated. Incident CVD was defined as fatal and non-fatal myocardial infarction, stroke, and coronary death. We included 3874 HNRS participants with available genetic data and had no known history of CVD at baseline. Cox proportional-hazards regression was used to test the association between the SNPs/GRS and incident CVD-risk adjusting for common CVD risk-factors. The analyses were further stratified by CVD risk-factors. During follow-up (12.1±4.31 years), 466 participants experienced CVD-events. No association between SNPs/GRS and CVD was observed in the adjusted analyses. However, the GRS, rs10936599, rs2487999 and rs8105767 increase the CVD-risk in current smoker. Few SNPs (rs10936599, rs2487999, and rs7675998) showed an increased CVD-risk, whereas rs10936599, rs677228 and rs4387287 a decreased CVD-risk, in further strata. The results of our study suggest different effects of SNPs/GRS on CVD-risk depending on the CVD risk-factor strata, highlighting the importance of stratified analyses in CVD risk-factors.

Spatial variations in the osteocyte lacuno-canalicular network density and analysis of the connectomic parameters

by Junning Chen, Marta Aido, Andreas Roschger, Alexander van Tol, Sara Checa, Bettina M. Willie, Richard Weinkamer

Osteocyte lacuno-canalicular network (LCN) is comprised of micrometre-sized pores and submicrometric wide channels in bone. Accumulating evidence suggests multiple functions of this network in material transportation, mechanobiological signalling, mineral homeostasis and bone remodelling. Combining rhodamine staining and confocal laser scanning microscopy, the longitudinal cross-sections of six mouse tibiae were imaged, and the connectome of the network was quantified with a focus on the spatial heterogeneities of network density, connectivity and length of canaliculi. In-vivo loading and double calcein labelling on these tibiae allowed differentiating the newly formed bone from the pre-existing regions. The canalicular density of the murine cortical bone varied between 0.174 and 0.243 μm/μm3, and therefore is three times larger than the corresponding value for human femoral midshaft osteons. The spatial heterogeneity of the network was found distinctly more pronounced across the cortex than along the cortex. We found that in regions with a dense network, the LCN conserves its largely tree-like character, but increases the density by including shorter canaliculi. The current study on healthy mice should serve as a motivating starting point to study the connectome of genetically modified mice, including models of bone diseases and of reduced mechanoresponse.

A longitudinal study of breastfeeding relationships at home during the COVID‐19 pandemic: A grounded theory method

Abstract

Aims

To describe the process of breastfeeding relationships among stay-at-home mother and infant dyads at 1, 3, 5 and 6 months.

Design

A longitudinal qualitative online survey design was used.

Methods

Data were obtained at 1, 3, 5 and 6 months from 26 breastfeeding mothers who stayed home with their infants and directly breastfed at least once a day for the first 6 months between June 2022 and August 2023. Mothers' written responses to 3 open-ended questions were analysed to assess breastfeeding experiences at home, thoughts/comments while directly breastfeeding and breastfeeding concerns/problems and strategies they used. Based on grounded theory, inductive content analysis was used to analyse the data. Trustworthiness of results was established by coding to consensus, formal peer debriefing and maintaining an audit trail.

Results

‘Breastfeeding Relationships at Home,’ the core construct, was identified and organized the process of breastfeeding relationships into 5 domains: (1) mothers' emotional well-being while breastfeeding, (2) infant-led feeding, (3) alternatives to breastfeeding, (4) evaluation of breastfeeding and (5) changes in breastfeeding as infants grow older.

Conclusion

Breastfeeding is not simply about feeding breast milk but also involves nurturing and developing a relationship between mother and infant. Across the domains, mutual responsiveness, a central element of the breastfeeding relationship was clear. Mothers who were committed to breastfeeding with embedded infant suckling reached emotional well-being in return for their engagement which has potential to reduce maternal stress and prevent postpartum depression.

Impact

Findings from the current study add to nurses' knowledge about the relationship building process between stay-at-home mothers and their infants in the first 6 months of breastfeeding during the COVID-19 pandemic. Nurses must remain sensitive to aid the development of breastfeeding relationships in the home environment to maximize mutual responsiveness.

Patient or Public Contribution

No patients or public involved.

Beyond order‐based nursing workload: A retrospective cohort study in intensive care units

Abstract

Introduction

In order to be positioned to address the increasing strain of burnout and worsening nurse shortage, a better understanding of factors that contribute to nursing workload is required. This study aims to examine the difference between order-based and clinically perceived nursing workloads and to quantify factors that contribute to a higher clinically perceived workload.

Design

A retrospective cohort study was used on an observational dataset.

Methods

We combined patient flow, nurse staffing and assignment, and workload intensity data and used multivariate linear regression to analyze how various shift, patient, and nurse-level factors, beyond order-based workload, affect nurses' clinically perceived workload.

Results

Among 53% of our samples, the clinically perceived workload is higher than the order-based workload. Factors associated with a higher clinically perceived workload include weekend or night shifts, shifts with a higher census, patients within the first 24 h of admission, and male patients.

Conclusions

The order-based workload measures tended to underestimate nurses' clinically perceived workload. We identified and quantified factors that contribute to a higher clinically perceived workload, discussed the potential mechanisms as to how these factors affect the clinically perceived workload, and proposed targeted interventions to better manage nursing workload.

Clinical Relevance

By identifying factors associated with a high clinically perceived workload, the nurse manager can provide appropriate interventions to lighten nursing workload, which may further reduce the risk of nurse burnout and shortage.

A Scoping Review of Studies Using Artificial Intelligence Identifying Optimal Practice Patterns for Inpatients With Type 2 Diabetes That Lead to Positive Healthcare Outcomes

imageThe objective of this scoping review was to survey the literature on the use of AI/ML applications in analyzing inpatient EHR data to identify bundles of care (groupings of interventions). If evidence suggested AI/ML models could determine bundles, the review aimed to explore whether implementing these interventions as bundles reduced practice pattern variance and positively impacted patient care outcomes for inpatients with T2DM. Six databases were searched for articles published from January 1, 2000, to January 1, 2024. Nine studies met criteria and were summarized by aims, outcome measures, clinical or practice implications, AI/ML model types, study variables, and AI/ML model outcomes. A variety of AI/ML models were used. Multiple data sources were leveraged to train the models, resulting in varying impacts on practice patterns and outcomes. Studies included aims across 4 thematic areas to address: therapeutic patterns of care, analysis of treatment pathways and their constraints, dashboard development for clinical decision support, and medication optimization and prescription pattern mining. Multiple disparate data sources (i.e., prescription payment data) were leveraged outside of those traditionally available within EHR databases. Notably missing was the use of holistic multidisciplinary data (i.e., nursing and ancillary) to train AI/ML models. AI/ML can assist in identifying the appropriateness of specific interventions to manage diabetic care and support adherence to efficacious treatment pathways if the appropriate data are incorporated into AI/ML design. Additional data sources beyond the EHR are needed to provide more complete data to develop AI/ML models that effectively discern meaningful clinical patterns. Further study is needed to better address nursing care using AI/ML to support effective inpatient diabetes management.

Exploring community participation in vectorborne disease control in Southeast Asia: a scoping review protocol

Por: Naserrudin · N. A. · Adhikari · B. · Culleton · R. · Hod · R. · Saffree Jeffree · M. · Ahmed · K. · Hassan · M. R.
Introduction

Vector borne diseases (VBDs) present significant public health challenges in Southeast Asia (SEA), and the increasing number of cases threatens vulnerable communities. Inadequate vector control and management have been linked to the spread of VBDs. To address these issues, community participation has been proposed as a promising approach to enhance health programmes and control of VBDs. This article outlines a protocol for a scoping review of the published literature on community-participation approaches to control VBDs in the SEA region. The primary research question is ‘How does community participation complement the control of VBDs in SEA?’ This review aims to provide an overview of various approaches and identify barriers and facilitators to effective implementation.

Methods and analysis

The research questions will guide the scoping review. In stage 1, peer-reviewed publications from PubMed, Web of Science and Scopus will be searched using predefined search terms related to community-based approaches and VBDs in the SEA region, English, Indonesian and Malay published between 2012 and 2022. In stage 2, the references from relevant articles will be screened for eligibility. In stage 3, eligible articles will be charted in Microsoft Excel to facilitate the review process, and studies will be characterised based on the investigated diseases; this review will also highlight the methodological context of these studies. In stage 4, a thematic analysis will be conducted to derive meaningful findings from the dataset relevant to the research inquiry, followed by writing the results in stage 5. This scoping review aims to be the first to explore community participation in VBD control in the SEA population, providing valuable insights for future research and stakeholders involved in disease control.

Ethics and dissemination

This scoping review does not require ethical approval because the methodology synthesises information from available articles. This review is planned for dissemination in academic journals, conference presentations and shared with stakeholders as part of knowledge sharing among those involved in VBD control.

Utilising a 'Community of Practice to support pharmacists to work in residential aged care: protocol for a longitudinal evaluation

Por: Lee · K. · Etherton-Beer · C. · Johnson · J. · Lobo · E. · Wang · K. · Ailabouni · N. · Mavaddat · N. · Clifford · R. M. · Page · A. T.
Introduction

A Community of Practice is briefly defined as a group of people with a shared interest in a given area of practice who work collaboratively to grow collective knowledge. Communities of Practice have been used to facilitate knowledge exchange and improve evidence-based practice. Knowledge translation within the residential aged care sector is lacking, with barriers such as inadequate staffing and knowledge gaps commonly cited. In Australia, a Federal inquiry into residential aged care practices led to a recommendation to embed pharmacists within residential aged care facilities. Onsite practice in aged care is a new role for pharmacists in Australia. Thus, support is needed to enable pharmacists to practice in this role.

The primary aim is to evaluate the processes and outcomes of a Community of Practice designed to support pharmacists to work in aged care.

Methods and analysis

A longitudinal, single-group, pretest–post-test design in which the intervention is a Community of Practice. The Community of Practice will be established and made available for 3 years to all Australian pharmacists interested in, new to or established in aged care roles. The Community of Practice will be hosted on online discussion platforms, with additional virtual meetings and annual symposia. The following data will be collected from all members of the Community of Practice: self-evaluation of the processes and outcomes of the Community of Practice (via the CoPeval scale) and confidence in evidence-based practice (EPIC scale), collected via online questionnaires annually; and discussion platform usage statistics and discussion transcripts. A subset of members will be invited to participate in annual semi-structured individual interviews.

Data from the online questionnaire will be analysed descriptively. Discussion transcripts will be analysed using topic modelling and content analysis to identify the common topics discussed and their frequencies. Qualitative data from individual interviews will be thematically analysed to explore perceptions and experiences with the intervention for information/knowledge exchange, impact on practice, and sharing/promoting/implementing evidence-based practice.

Ethics and dissemination

Human ethics approval has been granted by the University of Western Australia’s Human Ethics Committee (2023/ET000000). No personal information will be included in any publications and reports to funding bodies.

Findings will be disseminated to all members of the Community of Practice, professional organisations, social and mass media, peer-review journals, research and professional conferences and annual reports to the funding body.

Impact evaluation of a cash-plus programme for children with disabilities in the Xiengkhouang Province in Lao PDR: study protocol for a non-randomised controlled trial

Por: Banks · L. M. · Soukkhaphone · B. · Scherer · N. · Siengsounthone · L. · Carew · M. T. · Shakespeare · T. · Chen · S. · Davey · C. · Goyal · D. · Zinke-Allmang · A. · Kuper · H. · Chanthakoumane · K.
Introduction

More than 170 countries have implemented disability-targeted social protection programmes, although few have been rigorously evaluated. Consequently, a non-randomised controlled trial is being conducted of a pilot ‘cash-plus’ programme implemented by UNICEF Laos and the Laos government for children with disabilities in the Xiengkhouang Province in Laos. The intervention combines a regular cash transfer with provision of assistive devices and access for caregivers to a family support programme.

Methods and analysis

The non-randomised controlled trial will involve 350 children with disabilities across 3 districts identified by programme implementers as eligible for the programme (intervention arm). Implementers have also identified approximately 180 children with disabilities in neighbouring districts, who would otherwise meet eligibility criteria but do not live in the project areas (control arm). The trial will assess the impact of the programme on child well-being (primary outcome), as well as household poverty, caregiver quality of life and time use (secondary outcomes). Baseline data are being collected May–October 2023, with endline 24 months later. Analysis will be intention to treat. A complementary process evaluation will explore the implementation, acceptability of the programme, challenges and enablers to its delivery and mechanisms of impact.

Ethics and dissemination

The study has received ethical approval from the London School of Hygiene and Tropical Medicine and the National Ethics Committee for Health Research in Laos. Informed consent and assent will be taken by trained data collectors. Data will be collected and stored on a secure, encrypted server and its use will follow a detailed data management plan. Findings will be disseminated in academic journals and in short briefs for policy and programmatic actors, and in online and in-person events.

Trial registration number

ISRCTN80603476.

Analgesia for the treatment of acute pancreatitis: a protocol for a systematic review and network meta-analysis

Por: Subramani · S. S. · Berg · A. C. · Kral · L. A. · Murad · M. H. · Smith · A. · Phillips · A. E. · Yadav · D. · Uc · A. · Imdad · A.
Introduction

Gastrointestinal hospitalisations in the USA cause over US$130 billion in expenditures, and acute pancreatitis is a leading cause of these hospitalisations. Adequate pain control is one of the primary treatment goals for acute pancreatitis. Though opioids are commonly used for analgesia in these patients, there have been concerns about short-term and long-term side effects of using opioids. Recently, non-opioid medications have been studied to treat pain in patients with acute pancreatitis. This systematic review and network meta-analysis aims to assess the comparative efficacy of analgesic medication for non-severe, acute pancreatitis.

Methods and analysis

We will search multiple electronic databases for randomised controlled trials that study pain management in patients with non-severe, acute pancreatitis. The intervention will be any analgesic for acute pancreatitis in the hospital setting. The comparison group will be patients who received a placebo or other active interventions for pain management. The primary outcomes of interest include pain scores and the need for supplementary analgesia. The secondary outcomes will be serious adverse events, local complications, progression to severe pancreatitis, transfer to the intensive care unit, length of hospitalisation, time to start enteral feeds, 30-day all-cause mortality and Quality of Life Scale scores. If sufficient homogeneity exists among included studies, the findings will be pooled using a traditional pairwise and network meta-analysis. The risk of bias in randomised control trials will be evaluated using the Cochrane Risk of Bias Tool 2.0. The Grading of Recommendations, Assessment, Development, and Evaluation approach will be used to report the certainty of evidence.

Ethics and dissemination

This systematic review will not involve direct contact with human subjects. The findings of this review will be published in a peer-reviewed journal. They will give healthcare providers a better awareness of the optimal analgesic medication for pain treatment in non-severe, acute pancreatitis.

Understanding the impact of a residential housing program for people living with HIV/AIDS: results from a realist evaluation

Por: Ali · A. · Groot · G. · April · M. · MacPhee · M. · Witham · S. · Alimezelli · H. · Carr · T.
Background

In Canada, the Public Health Agency surveillance of new HIV cases has demonstrated annual increasing rates since 2020. The rates of new HIV cases are highest in the province of Saskatchewan.

Objectives

The aim of the project was to conduct a resident-oriented realist evaluation of an innovative supportive housing programme, Sanctum, for people living with HIV/AIDS who also face social care issues, such as homelessness. This project took place in Saskatchewan, a province that is seeking innovative approaches to improve quality of life and HIV/AIDS management for its citizens. Our evaluation addressed how and why participants were successful (or not) within the Sanctum programme.

Design and setting

Sanctum is a housing programme located in an inner-city location within the province of Saskatchewan. A unique component of this evaluation was the inclusion of an individual with lived experience, a resident partner, as a member of the research team.

Participants

11 recent Sanctum graduates, seven men and four women, were recruited for client partner-led in-depth, semistructured interviews.

Interventions

Prior to the evaluation, we developed a realist programme theory with potential causal explanations, known as context-mechanism-outcomes (CMO) configurations. Interview data from the evaluation and ongoing discussions with Sanctum board members and our resident partner were used to test, refine and validate the final programme theory and CMO configurations.

Results

CMO configurations at the micro (individual), meso (interpersonal) and macro (community) levels complement the over-arching programme theory. Key findings were the importance of Sanctum’s harm reduction philosophy, accompanied by a non-judgmental and patient-oriented approach. Participants were supported to reduce risky behaviour, improve self-care management and develop healthier relationships within a ‘safe’ home-like setting. Underlying mechanisms that contributed to participants’ success in the programme included: intrinsic motivation, self-worth, belongingness, empowerment and self-efficacy. Evidence-informed recommendations are offered to support Sanctum-like programme development for individuals with holistic health needs related to HIV/AIDS diagnoses and lack of access to necessary social determinants of health.

Conclusions

Stigma associated with HIV/AIDS and living circumstances, such as homelessness, were successfully addressed using harm reduction principles and judgement-free approaches within a family-like environment.

Low-dose naltrexone for post-COVID fatigue syndrome: a study protocol for a double-blind, randomised trial in British Columbia

Por: Naik · H. · Cooke · E. · Boulter · T. · Dyer · R. · Bone · J. N. · Tsai · M. · Cristobal · J. · McKay · R. J. · Song · X. · Nacul · L.
Introduction

A significant proportion of individuals suffering from post COVID-19 condition (PCC, also known as long COVID) can present with persistent, disabling fatigue similar to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-viral fatigue syndromes. There remains no clear pharmacological therapy for patients with this subtype of PCC, which can be referred to as post-COVID fatigue syndrome (PCFS). A low dose of the opioid antagonist naltrexone (ie, low-dose naltrexone (LDN)) has emerged as an off-label treatment for treating fatigue and other symptoms in PCC. However, only small, non-controlled studies have assessed LDN in PCC, so randomised trials are urgently required.

Methods and analysis

A prospective, randomised, double-blind, parallel arm, placebo-controlled phase II trial will be performed to assess the efficacy of LDN for improving fatigue in PCFS. The trial will be decentralised and open to eligible individuals throughout the Canadian province of British Columbia (BC). Participants will be recruited through the province-wide Post-COVID-19 Interdisciplinary Clinical Care Network (PC-ICCN) and research volunteer platform (REACH BC). Eligible participants will be 19–69 years old, have had a confirmed or physician-suspected SARS-CoV-2 infection at least 3 months prior and meet clinical criteria for PCFS adapted from the Institute of Medicine ME/CFS criteria. Individuals who are taking opioid medications, have a history of ME/CFS prior to COVID-19 or history of significant liver disease will be excluded. Participants will be randomised to an LDN intervention arm (n=80) or placebo arm (n=80). Participants in each arm will be prescribed identical capsules starting at 1 mg daily and follow a prespecified schedule for up-titration to 4.5 mg daily or the maximum tolerated dose. The trial will be conducted over 16 weeks, with assessments at baseline, 6, 12 and 16 weeks. The primary outcome will be fatigue severity at 16 weeks evaluated by the Fatigue Severity Scale. Secondary outcomes will include pain Visual Analogue Scale score, overall symptom severity as measured by the Patient Phenotyping Questionnaire Short Form, 7-day step count and health-related quality of life measured by the EuroQol 5-Dimension questionnaire.

Ethics and dissemination

The trial has been authorised by Health Canada and approved by The University of British Columbia/Children’s and Women’s Health Centre of British Columbia Research Ethics Board. On completion, findings will be disseminated to patients, caregivers and clinicians through engagement activities within existing PCC and ME/CFS networks. Results will be published in academic journals and presented at conferences.

Trial registration number

NCT05430152.

Paediatric off-label use of drugs in Gansu, China: a multicentre cross-sectional study

Por: Meng · M. · Ge · B. · Lei · W. · Wu · Y. · Tian · M. · Lu · Y. · Shao · T. · Yang · Y. · Luo · X. · Luo · J. · Gao · Y. · Li · Q. · Chen · Y.
Objective

To examine the current prevalence and cost of paediatric off-label drug prescriptions in Gansu, China, and the potential influencing factors.

Design

The prevalence of off-label prescriptions in paediatrics was evaluated according to the National Medical Products Administration drug instructions in the China Pharmaceutical Reference (China Pharmaceutical Reference, MCDEX) database. The evidence of the prescription was determined by existing clinical practice guidelines and the Thomson Grade in the Micromedex 2021 compendium. We used logistic regression to investigate the characteristics that influence paediatric off-label drug use after single-factor regression analysis.

Setting

A multicentre cross-sectional study of outpatient paediatric prescriptions in 196 secondary and tertiary hospitals in Gansu Province, China, in March and September 2020.

Results

We retrieved 104 029 paediatric prescriptions, of which 39 480 (38.0%) contained off-label use. The most common diseases treated by off-label drugs were respiratory system diseases (n=15 831, 40.1%). A quarter of off-label prescriptions had adequate evidence basis (n=10 130, 25.6%). Unapproved indications were the most common type of off-label drug use (n=25 891, 65.6%). A total of 1177 different drugs were prescribed off-label, with multienzyme tablets being the most common drug (n=1790, 3.5%). The total cost of the prescribed off-label drugs was ¥106 116/day. Off-label prescriptions were less frequent in tertiary than in secondary hospitals. Topical preparations were more commonly prescribed off-label than other types of drugs. Senior-level clinicians prescribed drugs off-label more often than intermediate and junior clinicians.

Conclusion

Off-label drug use is widespread in paediatric practice in China. Three-quarters of the prescriptions may potentially include inappropriate medication use, resulting in a daily economic burden of about ¥81 000 in 2020 in Gansu Province with 25 million inhabitants. The management of off-label drug use in paediatrics in China needs improvement.

Assessing the impact of obesity interventions in the early years: a systematic review of UK-based studies

Por: Michalopoulou · S. · Sifaki · M. · Packer · J. · Lanigan · J. · Stansfield · C. · Viner · R. M. · Russell · S.
Objectives

Childhood obesity rates in the UK are high. The early years of childhood are critical for establishing healthy behaviours and offer interventional opportunities. We aimed to identify studies evaluating the impact of UK-based obesity interventions in early childhood.

Design

Systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources

Nine databases were searched in March 2023. Eligibility criteria: We included UK-based obesity intervention studies delivered to children aged 6 months to 5 years that had diet and/or physical activity components and reported anthropometric outcomes. The primary outcome of interest was z-score Body Mass Index (zBMI) change (within and between subjects). Studies evaluating the effects of breastfeeding interventions were not included as obesity prevention interventions, given that best-practice formula feeding is also likely to encourage healthy growth. The publication date for studies was limited to the previous 12 years (2011–23), as earlier reviews found few evaluations of interventions in the UK.

Data extraction and synthesis

The reviewers worked independently using standardised approach to search, screen and code the included studies. Risk of bias was assessed using Cochrane tools (ROB 2 or ROBINS-I).

Results

Six trials (five studies) were identified, including two randomised controlled trials (RCT), one cluster randomised trial (CRT), two feasibility CRTs and one impact assessment. The total number of participants was 566. Three trials focused on disadvantaged families and two included high-risk children categorised as having overweight or obesity. Compared with baseline, five interventions reported reductions in zBMI, three of which were statistically significant (p

Conclusion

UK evidence was limited but some interventions showed promising results in promoting healthy growth. As part of a programme of policies, interventions in the early years may have an important role in reducing the risk of childhood obesity.

PROSPERO registration number

CRD42021290676

Interdisciplinary research approach based on a mixed-methods design to explore patient altruism at the end of life: a study protocol

Por: Bernard · M. · Gamondi · C. · Sterie · A.-C. · Larkin · P. J. · Jox · R. · Borasio · G. D.
Introduction

In the end of life context, patients are often seen as somewhat passive recipients of care provided by health professionals and relatives, with little opportunity to be perceived as autonomous and active agents. Since studies show a very high prevalence of altruistic dispositions in palliative care patients, we strive to investigate the concept of patient altruism in a set of six interdisciplinary studies by considering three settings: (1) in the general palliative context—by studying to what extent patient altruism is associated with essential psychological outcomes of palliative care (subproject 1a), how altruism is understood by patients (subproject 1b) and how altruism expressed by patients is experienced by palliative care nurses (subproject 1c); (2) in two concrete decision-making contexts—advance care planning (subproject 2a) and assisted suicide (subproject 2b); and (3) through verbal and non-verbal patient communication in palliative care settings (subproject 3).

Methods and analysis

Subproject 1a: a cross-sectional study using validated and standardised questionnaires. Subprojects 1b and 1c: a constructivist grounded theory method aiming at developing a novel theory from semistructured interviews in both patients and nurses. Subproject 2a: a thematic analysis based on (1) audio-recordings of advance care planning encounters and (2) follow-up semidirective interviews with patients and their relatives. Subproject 2b: a qualitative study based on thematic analysis of interviews with patients actively pursuing assisted suicide and one of their relatives.Subproject 3: a conversation analysis based on audio and video-recorded interactions in two settings: (1) palliative inpatient unit and (2) advance care planning discussions.

Ethics and dissemination

The study project was approved by the Ethics Committees of the Canton of Vaud, Bern and Ticino (no: 2023-00088). In addition to participation in national and international conferences, each project will be the subject of two scientific publications in peer-reviewed journals. Additional publications will be realised according to result triangulation between projects. A symposium opened to professionals, patients and the public will be organised in Switzerland at the end of the project.

Hungarian general practice paediatricians antibiotic prescribing behaviour for suspected respiratory tract infections: a qualitative study

Por: Babarczy · B. · Hajdu · A. · Benko · R. · Matuz · M. · Papp · R. · Antoniou · P. · Kandelaki · K. · Lo Fo Wong · D. · Warsi · S. K.
Objectives

Inappropriate antibiotic prescribing is a major cause of antimicrobial resistance (AMR). The aim of this study was to explore paediatric general practitioners’ (GP Peds) antibiotic prescription practice in suspected respiratory tract infections (RTIs), using the capability–opportunity–motivation–behaviour framework.

Design

The design is a qualitative study based on individual, semistructured telephone or virtual interviews.

Setting

Paediatric general practice in Hungary. We applied stratified maximum variation sampling to cover the categories of age, sex and geographical location of participants.

Participants

We interviewed 22 GP Peds. Nine were male and 13 were female: 2 of them were less than 40 years old, 14 were between 40 and 60 years, and 6 were above 60 years. 10 worked in low-antibiotic prescription areas, 5 in areas with medium levels of antibiotic prescription, 3 in high-antibiotic prescription areas, and 4 in and around the capital city.

Results

Study participants had varying antibiotic prescription preferences. Personal experience and physical examination play a central role in GP Peds’ diagnostic and treatment practice. Participants emphasised the need to treat children in their entirety, taking their personal medical record, social background and sometimes parents’ preferences into account, besides the acute clinical manifestation of RTI. Most respondents were confident they apply the most effective therapy even if, in some cases, this meant prescribing medicines with a higher chance of contributing to the development of AMR. Some participants felt antibiotic prescription frequency has decreased in recent years.

Conclusions

Our findings suggest that a more prudent attitude toward antibiotic prescribing may have become more common but also highlight relevant gaps in both physicians’ and public knowledge of antibiotics and AMR. To reinforce awareness and close remaining gaps, Hungary should adopt its national AMR National Action Plan and further increase its efforts towards active professional communication and feedback for primary care physicians.

Study protocol for two randomised controlled trials evaluating the effects of Cerclage in the reduction of extreme preterm birth and perinatal mortality in twin pregnancies with a short cervix or dilatation: the TWIN Cerclage studies

Por: van Gils · L. · de Boer · M. A. · Bosmans · J. · Duijnhoven · R. · Schoenmakers · S. · Derks · J. B. · Prins · J. R. · Al-Nasiry · S. · Lutke Holzik · M. · Lopriore · E. · van Drongelen · J. · Knol · M. H. · van Laar · J. O. E. H. · Jacquemyn · Y. · van Holsbeke · C. · Dehaene · I. · L
Introduction

Twin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and mortality. Currently there is a lack of effective treatments for women with a twin pregnancy and a short cervix or cervical dilatation. A possible effective surgical method to reduce extreme PTB in twin pregnancies with an asymptomatic short cervix or dilatation at midpregnancy is the placement of a vaginal cerclage.

Methods and analysis

We designed two multicentre randomised trials involving eight hospitals in the Netherlands (sites in other countries may be added at a later date). Women older than 16 years with a twin pregnancy at

Ethics and dissemination

This study has been approved by the Research Ethics Committees in the Netherlands on 3/30/2023. Participants will be required to sign an informed consent form. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results.

Trial registration number

ClinicalTrials.gov, NCT05968794.

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