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AnteayerBMJ Open

Translation and measurement properties of Persian version of Child-to-Parent Violence Questionnaire

Por: Abdolalipour · S. · Hosseinzadeh · M. · Khalili · M. · Asghari Jafarabadi · M. · Mirghafourvand · M.
Objective

Child-to-parent violence (CPV) has received limited attention in scientific literature, but due to a recent increase in reported cases, it has become a subject of investigation. The reliability and validity of the Child-to-Parent Violence Questionnaire (CPV-Q), in separate mother and father versions, have not yet been studied in Iran. This study aimed to assess the psychometric properties of the Persian CPV-Q.

Design

This research employed a cross-sectional design to evaluate the Persian CPV-Q’s psychometric properties. The process included translation (using backward-forward method), face validity (via impact score calculation), content validity (using content validity ratio (CVR) and content validity index (CVI)), construct validity (through exploratory and confirmatory factor analyses (CFA)) and reliability assessment (via test–retest, coefficient α, coefficient and intraclass correlation coefficient (ICC)).

Setting

The study was conducted at the Faculties of Tabriz University of Medical Sciences.

Participants

A total of 500 qualified students from Tabriz University of Medical Sciences were recruited using cluster random sampling. These participants completed the Persian CPV-Q.

Results

Face validity was confirmed, with impact scores exceeding 1.5 for all items. Content validity was strong, with CVR=0.92 and CVI=0.89. Exploratory factor analysis revealed four factors related to violence frequency and two factors regarding reasons for violence, consistent with the original questionnaire, covering 19 and 8 items, respectively. Total variance explained was 0.30 and 0.39 for the mother’s version and 0.33 and 0.43 for the father’s version in frequency and reason sections. The Kaiser-Meyer-Olkin test confirmed sample adequacy (

Conclusions

The Persian CPV-Q demonstrates adequate validity and reliability for assessing the prevalence and causes of CPV in Iranian society.

Effect of curcumin on fatigue and musculoskeletal health in postmenopausal women: a double-blind randomised controlled trial

Por: Shabani · F. · Mashayekh-Amiri · S. · Mousavi · Z. · Shaseb · E. · Mirghafourvand · M.
Objectives

Considering the proven anti-inflammatory effects of curcumin, we aimed to investigate the effect of curcumin supplementation on fatigue and musculoskeletal health (primary outcomes) and depression and its side effects (secondary outcomes) in postmenopausal women.

Design

This was a parallel-group, double-blind, randomised placebo-controlled superiority trial.

Setting

The trial was conducted at two general clinics in Tabriz, Iran, in 2023.

Participants

A total of 74 postmenopausal women were enrolled. The participants were women aged between 40 years and 60 years with normal menopause and at least 1 year after amenorrhoea.

Intervention

They were randomly assigned (1:1 allocation ratio) using a block randomisation method to receive either 500 mg curcumin capsules (intervention group, n=37) or identical placebo capsules (control group, n=37) twice daily for 8 weeks. Both participants and researchers were blinded to the group assignments.

Primary and secondary outcome measures

Data were collected using the questionnaires of demographic characteristics, short form of the perimenopausal fatigue scale, musculoskeletal health, Beck Depression Inventory (BDI-13) and the side effects checklist. Independent t, ANCOVA and Mann-Whitney U tests were used to compare the results between the two groups.

Results

A total of 74 women were randomised, with 33 in the curcumin group and 31 in the placebo group completing the study and being included in the final analysis. After the 8-week intervention, ANCOVA adjusting for baseline values revealed that the curcumin group showed a statistically significant improvement in musculoskeletal health (mean difference (MD): 5.3; 95% CI: 3.3 to 7.4; p

Conclusion

In this trial, an 8-week supplementation with curcumin was more effective than placebo at improving musculoskeletal health and reducing fatigue score in postmenopausal women. The study was not able to demonstrate a significant effect on depression.

Trial registration number

Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N72. Last updated version: 18 October 2022. Actual start of recruitment: 23 January 2023.

Effectiveness of a novel intervention (Super Rehab) in overweight patients with atrial fibrillation (SuRe AF): protocol for a randomised controlled trial

Por: Murphy · D. · Graby · J. · Smith · T. · Peacock · O. · Abramik · J. · Antoniades · C. · Rodrigues · J. C. L. · Thompson · D. · Khavandi · A.
Introduction

Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide, associated with significant morbidity, mortality and healthcare utilisation. AF rhythm control strategies demonstrate attrition with time. A number of modifiable AF risk factors contribute to an atrial cardiomyopathy culminating in incident AF but importantly also recurrence. We propose that a novel multidisciplinary lifestyle intervention (Super Rehab, SR) may improve symptoms and AF burden.

Methods and analysis

This is a single-centre, randomised controlled study. Patients aged ≥18 years with a body mass index ≥27 kg/m2 with paroxysmal or persistent AF will be randomised 1:1 to National Health Service (NHS) usual care (UC) or to SR (together with NHS UC). SR incorporates high-intensity exercise, personalised dietary advice and AF risk factor modification. SR will be undertaken over 12 months. In addition to baseline assessments, follow-up assessments will occur at the 6, 12 and 15-month time points. The primary outcome will be the difference in AF symptom burden at 12 months between groups. Secondary outcomes include AF burden (assessed by an implantable cardiac monitor), changes to cardiac structure and function and computed tomography-based assessment of epicardial adipose tissue.

Ethics and dissemination

Ethics approval was granted by London-Chelsea Research Ethics Committee (reference: 22/LO/0479 22/08/2022). All participants will provide written informed consent prior to enrolment. Study findings will be disseminated via presentations to relevant stakeholders, national and international conferences and open-access peer-reviewed research publications. A summary will also be communicated to the participants.

Trial registration number

ClinicalTrials.gov ID NCT05596175.

Applications of implementation science (IS) in learning health systems (LHS): a scoping review protocol

Por: Huang · A. K. · Vanderkruik · R. · Mita · C. · Argueta · S. · Bartels · S. J.
Introduction

Despite advancements in biomedical and healthcare research, the translation of evidence into routine practice within healthcare systems often lags, perpetuating inefficiencies and disparities in care delivery. Learning health systems (LHS), which integrate internal data and external evidence for continuous improvement, hold promise for addressing these gaps. Implementation science (IS), focused on promoting the systematic uptake of evidence-based practices, offers a robust framework to drive sustainable improvements within LHS. However, the practical application of IS principles in LHS remains underexplored. This scoping review aims to systematically map the literature on the application of IS in LHS, highlighting themes, gaps and opportunities for advancing future practices.

Methods and analysis

This review will follow the Joanna Briggs Institute (JBI) methodology for scoping reviews, supported by the Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews (PRISMA-ScR) checklist. The review employs a population-concept-context framework, focusing on studies engaged in LHS activities and the application of IS principles in various healthcare settings. Relevant literature will be searched across multiple databases, including OVID/Medline, Embase, Web of Science Core Collection and Health Policy Reference Center. Eligible studies will be screened, and data will be extracted and synthesised using both quantitative and qualitative methods. Key outcomes include characterising IS applications in LHS, evaluating barriers and facilitators, exploring equity integration, and identifying knowledge gaps.

Ethics and dissemination

As this study does not involve primary data collection, ethical approval is not required. Findings will be disseminated through peer-reviewed publications and conference presentations to inform future research and practice.

Registration

This protocol has been registered on the Open Science Framework (DOI: 10.17605/OSF.IO/BMQ6J).

Intensive care clinicians experiences of palliative withdrawal of mechanical ventilation: a qualitative study

Por: Efstathiou · N. · Diridis · F. K. M. · Orr · M. · Baernholdt · M. · Vanderspank-Wright · B.
Objectives

To explore intensive care unit (ICU) clinicians’ experiences of withdrawing mechanical ventilation during end-of-life care.

Design

An exploratory qualitative design was used, with data collected via semistructured, face-to-face online interviews and analysed using reflexive thematic analysis.

Participants

We recruited ICU clinicians from two hospitals within the West Midlands region of the UK.

Data collection

Semistructured, face-to-face online interviews were used to explore experiences with limitation of life-sustaining treatments in ICU, decision-making and practices for withdrawing mechanical ventilation.

Findings

22 ICU clinicians were interviewed (Physiotherapist=1, Advanced Critical Care Practitioners=4, Physicians=9 and Nurses=8), of which 13 were women (59%). Four themes were developed. (1) Multilayered communication: effective communication was key in planning withdrawal and informing family members, with conflicts arising from cultural differences. (2) Considerations regarding the mode of withdrawing invasive mechanical ventilation: clinicians expressed differing preferences for the method of mechanical ventilation withdrawal. (3) Multiprofessional teamwork: collaborative teamwork was vital, with palliative care practitioners consulted during conflicts or challenging symptoms. (4) Clinicians’ feelings and impact: clinicians empathised with families and experienced psychological burden.

Conclusions

Physician preferences influence the withdrawal process, which is communicated within the multidisciplinary team. Clear protocols can help reduce ambiguity and support less experienced clinicians. Reflection on these practices may help mitigate burnout and compassion fatigue. Further research should examine the effects of physician demographics and patient cultural diversity on the withdrawal process.

Psychological birth trauma and its related factors, and providing strategies for prevention of psychological birth trauma: protocol for an explanatory sequential mixed-method study

Background

Childbirth can have psychological, social and emotional effects on women and their families. Psychological birth trauma (PBT) is defined as the emotional distress and mental health challenges resulting from negative or distressing experiences during the childbirth process. Labour management plays an important role in the health of women and children. Consequently, the study aims to assess the status of PBT among Iranian women, identify factors influencing it and suggest effective preventive strategies.

Methods and analysis

This study is a mixed-method research with an explanatory sequential approach. The first phase is quantitative and cross-sectional, involving 300 postpartum women visiting health centres in Tabriz-Iran. In this phase, cluster sampling will be used, and data will be collected using the following questionnaires: Sociodemographic and Obstetric Characteristics, Birth Trauma Scale, PTSD Symptom Scale 1, Perceived Quality of Care Scale, Childbirth Experience Questionnaire version 2.0, Edinburgh Postpartum Depression Scale, Postpartum Specific Anxiety Scale Research Short-Form and the questionnaire on the desire for subsequent pregnancy. The second phase is qualitative, and participants will be selected based on the results of the quantitative phase and extreme cases, using purposive sampling. Data analysis will be performed using qualitative content analysis with a conventional approach. Qualitative data will be collected through in-depth and semi-structured individual interviews with open-ended questions. In the third phase, strategies to prevent childbirth psychological trauma will be designed by integrating the results of the quantitative and qualitative studies, reviewing the literature and gathering expert opinions using a modified Delphi study. Examining PBT and its influencing factors can provide culturally relevant, evidence-based strategies. These strategies can be effective in improving the quality of care for women during childbirth.

Ethics and dissemination

This study has received approval from the Ethics Committee of Tabriz University of Medical Sciences in Tabriz, Iran (code number: IR.TBZMED.REC.1402.945). All participants will provide written informed consent before taking part in the study. The outcomes will be shared through articles published in journals, presentations at medical conferences, the validation of a reliable scale for assessing the level of PBT in postpartum women, and the provision of strategies to prevent childbirth psychological trauma. These resources will be valuable for policymakers and healthcare providers.

Somatostatin analogue continuation upon progression in patients with gastroenteropancreatic neuroendocrine tumour (SAUNA trial): a randomised controlled trial protocol

Por: Chhajlani · S. · Kuiper · J. · Beutels · P. · Borbath · I. · Dercksen · W. · Deroose · C. M. · Heemskerk · S. · Polinder · S. · Roelant · E. · Smits · E. · Verhaegen · I. · Van der Massen · I. · Walenkamp · A. · de Herder · W. W. · Peeters · M. · Hofland · J. · Vandamme · T. · for the SA
Introduction

Gastroenteropancreatic neuroendocrine tumours (GEP NET) are malignant neoplasms that impact survival. Somatostatin analogues (SSA) are used for treating hormonal symptoms caused by GEP NET and have antiproliferative effects. They are used as first-line therapy in patients with advanced GEP NET, but disease control is limited to a median progression-free survival (mPFS) of 14–32 months. Second-line treatment options include targeted therapy (everolimus or sunitinib), or peptide receptor radionuclide therapy (PRRT) with 177Lu-DOTATATE. In patients suffering from a NET-related hormonal syndrome, SSA is generally continued life-long. However, there is no consensus on whether it is beneficial to continue SSA in non-functional NET upon disease progression. Due to the ongoing activity of the somatostatin receptor pathway in GEP NET progressing on first-line SSA, we hypothesise that SSA have an added efficacy in second-line therapy.

Methods and analysis

The SAUNA trial is an international, multicentre, open-label, randomised, controlled, pragmatic clinical trial. 270 patients with advanced, non-functional GEP NET and progression under first-line SSA will be included in substudy 1 (PRRT; n=142) or substudy 2 (targeted therapy (everolimus/sunitinib); n=128) per investigator’s choice of second-line therapy and will be randomised (1:1) per substudy between SSA continuation or SSA withdrawal arms. Co-primary endpoints are the difference in progression-free survival (PFS) according to the RECIST (Response Evaluation Criteria In Solid Tumours) V.1.1 criteria and difference in time to deterioration (TTD) in quality of life (QoL) per substudy after initiating second-line therapy with or without SSA. Secondary endpoints include the PFS rate at 18 months, the difference in pooled PFS and TTD combining both substudies, overall survival, response rates, QoL, costs, cost-effectiveness and toxicity. The study design was developed in cooperation with the Belgium and Dutch patient organisations.

Ethics and dissemination

The study has been approved on 31 May 2023 by the Ethical Committees and Regulatory Authorities of the concerned member states (EU CT number 2022-502703-30-00). Both the trial management group and the steering committee will oversee good governance of this trial. Results of the study will be published in peer-reviewed international journals and presented at international conferences.

Trial registration number

NCT05701241.

Realist evaluation of Belgian pilot projects for paediatric transmural care: protocol for a mixed methods study

Introduction

The Belgian healthcare system is to a large extent hospital-centred, prompting government initiatives to shift care towards patient’s homes and reduce hospital stays. To avoid unnecessary hospital stays and offer alternative and innovative forms of care, the Belgian federal health authorities selected five pilot projects for transmural care for chronically ill children. Guided by the Medical Research Council framework, this study aims to evaluate the paediatric transmural care projects to inform new models for paediatric care.

Methods and analysis

Using a mixed-methods realist evaluation, the study comprises three phases: (1) initial programme theory development, (2) initial programme theory testing and (3) programme theory refinement. In a first phase, the initial programme theory rooted in the normalisation process theory will be refined from insights retrieved from document review and focus group interviews with healthcare professionals. In the second phase, the initial programme theory will be tested using empirical data. Routine data and questionnaires will examine whether characteristics of participants and outcomes are in line with the quintuple aim framework. Focus groups with children, parents and stakeholders, and document analysis will be used to evaluate the structure of the intervention, examine the process and context, and understand more in-depth the outcomes. A budget impact analysis will be used to assess whether the pilot project is affordable. In a third phase, qualitative and quantitative data will be analysed using a convergent mixed-methods model, involving continuous triangulation of multiple data sets to facilitate greater understanding of the context and refinement of the programme theory.

Ethics and dissemination

The study protocol was reviewed and approved by the Ethics Committee of the Ghent University Hospital (Belgian Registration Number B6702024000193) after consultation with all Ethics Committees of the participating hospitals. Written informed consent will be obtained from participants or their legal representatives prior to data collection. Participant confidentiality will be maintained throughout the study. Study results will be published in international peer-reviewed journals and will be presented at national and international conferences. The general population will be informed of the aggregated results.

Trial registration number

ClinicalTrials.gov, NCT06679595.

LymphSens study: the enigma of subjective lymphoedema - how often and why do patients report lymphoedema after breast cancer treatment without an objective measurable swelling? The role of lymphatic and sensory processing problems: a protocol for a multic

Por: Gursen · C. · Meeus · M. · Verbeelen · K. · Vets · N. · Spincemaille · L. · Smeets · A. · Thomis · S. · Fieuws · S. · Vanderheyden · H. · Gebruers · N. · Tjalma · W. · Johansson · K. · Keeley · V. · De Groef · A. · Devoogdt · N.
Introduction

Breast cancer-related lymphoedema (BCRL) at the arm and/or trunk/breast is a highly feared complication following breast cancer treatment and can be objectified using the state-of-the-art criteria based on volume, extracellular water ratio or skin thickness measurements. Although the incidence of objective BCRL is decreasing due to advances in breast cancer treatment, many patients report a sensation of swelling without the presence of objective BCRL, referred to as subjective BCRL. As little is known about the prevalence and the transitions between different BCRL states (no-subjective-objective) over time, as well as about the underlying mechanisms and contributing factors of subjective BCRL, this will be investigated in the LymphSens study.

Methods and analysis

230 patients with a new diagnosis of unilateral breast cancer will be included in a multicentre longitudinal study. Measurements are performed from presurgery to 12 months postsurgery. The primary objective (aim 1) is to determine the prevalence rate of subjective and objective BCRL at 1, 6 and 12 month(s) postsurgery, as well as transitions between BCRL states (no-subjective-objective BCRL) by a multinomial logistic regression model with generalised estimating equations and transition matrices, respectively. A second objective (aim 2) is to determine factors related to four potential underlying mechanisms (lymphatic, nociceptive, neuropathic and central sensory processing problems) that contribute to the occurrence of subjective BCRL in comparison with no self-reported swelling and objective BCRL. As a third objective (aim 3), within the group of patients with subjective BCRL, we will determine factors related to these four underlying mechanisms that contribute to the severity of subjective BCRL. The analyses for aim 2 and aim 3 will be conducted both at specific time points, that is, 1, 6 and 12 month(s) postsurgery using exploratory analysis and across all time points collectively using multivariable binary logistic regression models or multivariable longitudinal models for repeated measures.

Ethics and dissemination

The LymphSens study protocol received approval from the Ethics Committee of UZ Leuven (S68133) and UZ Antwerp/University of Antwerp (5676-003252). The results of the LymphSens study will be presented at conferences and published in peer-reviewed journals.

Trial registration number

NCT06324721.

Impacts on quality of care following electronic health record implementation within a large Canadian community hospital: a qualitative study

Por: Vanderhout · S. · Taneja · S. · Heidebrecht · C. L. · Nie · J. X. · Seuren · L. · Giri · R. · Tang · T. · Mansfield · E. · Kuluski · K. · Wodchis · W. P.
Objective

This study aimed to describe how healthcare providers perceived the impacts of implementing and using an electronic health record (EHR) on quality, safety and person-centredness of care.

Design

A qualitative descriptive design using semistructured interviews.

Setting

In October 2020, a large Canadian community hospital implemented a new EHR system (Epic) across three sites, transitioning from a previously fragmented (combination of paper-based and electronic) system.

Participants

Sixty-two healthcare providers and clinical leaders.

Results

Participants shared their experiences regarding the impact of EHR implementation on quality of care, which were analysed into common themes including task efficiency, information management, patient interactions and patient safety. While the system significantly altered their routines and introduced new responsibilities like additional documentation requirements, it also facilitated adherence to clinical guidelines, improved information visibility and enhanced documentation, benefiting overall quality of care and patient safety. Participants reported that EHR implementation led to increased efficiency, freeing up time for patient care and improving communication with patients and other providers.

Conclusion

EHRs have the potential to improve quality of care and patient safety, but this depends on their perceived value and how well healthcare providers can integrate their various features into clinical routines.

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