Information Sheet Research Articles

The effect of therapeutic education program on hypertensive Tunisian patients’ knowledge: a randomized controlled trial

Background: Hypertension is a prevalent non-communicable disease and unequivocally one of the most serious health threats of the twenty-first century. The prevention of both immediate and long-term consequences depends on ongoing therapeutic education. Aims: To assess Tunisian hypertensive patients’ knowledge of hypertension and then evaluate the impact of an educational program on knowledge among this population. Methods: A randomized controlled trial was carried out among 639 hypertensive patients in Tunisia. The control group received only basic medical care, while the experimental group acquired additionally an educational program. The data collection tool was a questionnaire that included an information sheet and the Hypertension Knowledge Level Scale (HK-LS). Results: Before to the implementation of the program, only 12.1% of the participants had a good level of knowledge about hypertension (12.8% for the experimental group, vs. 10.5% for the control group, P=0.57). Following the program’s deployment, the rate of good level of knowledge became 63.6% for the experimental group vs. 11.4% for the control group, P<0.001). The results revealed that the experimental group showed a significant amelioration in the total score of the HK-LS: from 58.49 to 76.94%, P<0.0001. In contrast, no significant amelioration was noted in the control group. Concerning the six dimensions of the scale, the amelioration in the experimental group was observed in all dimensions, except the treatment dimension. Conclusion: Overall, the findings indicated low levels of knowledge about hypertension. This kind of approach proved an effective improvement in disease-related knowledge and may be essential for hypertension management.

Comic-based consenting on patient-reported experience and outcome measures for transfemoral aortic valve implantation

Abstract Background The impact of an improved patient informed consent (IC) before transcatheter aortic valve implantation (TAVI) on patient-reported experience and outcome measures (PREMs and PROMs) as well as on clinical outcomes remains unclear. Purpose To investigate patient satisfaction, PREMs, PROMs and clinical outcomes in patients receiving additional illustrative graphic-based IC (comic group) compared to conventional IC (control group) for TAVI at two tertiary care centers as part of a randomised controlled trial ("TAVI-COMIC study"). Methods Adult patients undergoing elective TAVI were enrolled. Patient satisfaction and PREMs were assessed after providing IC, PROMs at 90 days after TAVI and clinical safety outcomes within 7 days after TAVI (Figure). Results Only 48 (32%) of all patients read the official usual patient information sheet. Of 299 patients undergoing TAVI, comic-based IC was performed in 152 (51%) patients. Patient satisfaction was significantly higher (29 [23-32] vs 25 [22-30] of a maximum of 32 points in the validated Client Satisfaction Questionnaire [CSQ], p<0.001) and anxiety was lower (34 [25-51] vs 39 [29-55], p<0.001 in the validated Spielberger State-Trait-Anxiety Inventory [STAI]) in the comic group. 92 (61%) patients in the comic group felt "relaxed" prior to the procedure compared to only 44 (30%) patients receiving conventional IC (p<0.001). 91 (60%) were "very satisfied" with the delivered patient IC compared to 28 (19%) patients in the control group (p<0.001). PROMs at 90 days were assessed in a subgroup of 198 (66% of total cohort) patients: The comic group had similar PROMs as the control group (e.g. general health condition, walking ability and rate of dizziness, syncope, helplessness, depression, dyspnea or angina). Clinical outcomes, such as bleeding, pneumonia, stroke, delirium, or TAVI unit and hospital length of stay, were similar in both groups. Conclusion Use of an alternative IC approach, such as medical graphic narratives, might significantly improve patient satisfaction and PREMs, while facilitating similar PROMs and procedural safety as conventional treatment strategies.

Assessing the practicality of a novel heart failure therapeutic score (QUAD Score) for drug optimisation in heart failure with a reduced ejection fraction

Abstract Introduction The 4 pillars of drug treatment for heart failure with a reduced ejection fraction (HFrEF) [Angiotensin-converting enzyme inhibitors (ACEi)/Angiotensin receptor–neprilysin inhibitors (ARNi), β-blockers (BB), Mineralocorticoid receptor antagonists (MRA), and Sodium-glucose cotransporter 2 inhibitors (SGLT2i)], are recommended by international HF guidelines to improve patient outcomes. Treatment inertia remains a challenge with non-prescription or sub-optimal dosing of these therapies. We developed a pragmatic HFrEF treatment score (QUAD score) (Figure 1) to prompt initiation and/or titration of sub-optimally dosed foundational therapies. Patients are categorized as poor (<8), good (8-14), and excellent (15-24) based on the dose and number of foundational drugs prescribed. This study aims to assess the practical utility of the QUAD score and its influence on treatment optimization. Methods Unwarned prescribing HCPs were approached consecutively in person, within clinical settings. Participants were told the questions were part of a research project and they provided verbal consent. Responses were anonymous and no patients were involved; therefore, verbal consent was considered proportionate and reasonable. HCPs were given an information sheet describing the QUAD score (Figure 1). They were then presented with 3 hypothetical clinical scenarios of haemodynamically stable and uncomplicated HFrEF patients with uncalculated poor, good and excellent QUAD scores. They were asked to calculate the QUAD score and if they proposed any changes to treatment. Time was recorded using a stopwatch and proposed changes were recorded. They were then invited to answer a series of follow-on questions. Results Between September 2023 and February 2024, there were 70 respondents. 71% (50) were doctors and 29% (20) allied HCPs. 83% (58) placed patients in the correct treatment grade in at least one scenario. 62.9% (44) did so for all three scenarios (Figure 2) with numerically more HCPs compared to doctors (80% vs 56% p=0.06).The median (IQR) time in seconds required to calculate the QUAD score for clinical scenarios 1,2 and 3 was 158 (100-234), 86 (54-122) and 83 (53-119) respectively. In response to the calculated QUAD score, 94.3% (66), recommended drug treatment optimisations. On a 5-point Likert scale (1 -poor, 5- excellent), 77.1% of participants rated the QUAD score ≥3 for ease of use, and 88.6% rated ≥3 as an incentive for treatment optimization. Conclusion We demonstrated the rapid clinical usability of the QUAD Score in a cohort of unselected prescribing HCPs, with a decremental calculation time with each presented clinical scenario. HCPs were also motivated to achieve further HF drug therapy optimization based on the calculated score. We conclude that the QUAD Score as a HFrEF drug therapy score may have a role in addressing treatment inertia however, it needs validation against clinically relevant outcomes in a larger cohort of HFrEF patients.

Medication Adherence, Blood Pressure Control, Knowledge, Self-care and Self-efficacy among Tunisian Hypertensive Patients

Objectives The aim of this study was to investigate the associated factors with adherence to antihypertensive therapy and to explore the association between medication adherence, blood pressure control, knowledge about hypertension (HTN), self-care, and self-efficacy in hypertensive patients. Methods A cross-sectional study was conducted among 750 hypertensive patients in Tunisia. The data collection tool was a 5-section questionnaire including an information sheet, the Girerd medication adherence scale, the HTN Knowledge Level Scale (HK-LS), the Self-care of HTN Inventory (SC-HI), and the Self-Efficacy for Managing Chronic Disease 6-Item Scale (SEM6S). Results A low and moderate level of medication adherence has been observed in 83.2% of the participants. Uncontrolled blood pressure was detected in 73.1% of cases. Only 11.5% have a good level of knowledge about HTN. Concerning Self-care practices, 48.8% of patients have inadequate practices of maintenance, 48.8% have inadequate practices of monitoring, and 83.9% have inadequate practices of management. The self-efficacy for managing HTN was weak in 42.1% of the participants. In multivariate analysis, low medication adherence was associated with the number of antihypertensive pills/day (ORa=2.668; CI95%= (1.447- 4.918) if ≥ 4 pills/day), side effects (ORa=1.834; CI95%= (1.263- 2.665); p=0.001), uncontrolled hypertension (ORa=2.74; CI95%= (1.798- 4.18); p<0.0001), insufficient self-efficacy for managing HTN (ORa=1.773; CI95%=(1.252- 2.512); p<0.0001), and insufficient self-care maintenance (ORa=2.220; CI95%=(1.562- 3.1570); p<0.0001). Conclusion Low medication adherence was associated with uncontrolled blood pressure, more anti-hypertensive pills, side effects, lower self-efficacy, and lower self-care maintenance. Nursing interventions improving the management skills of hypertensive patients may be beneficial in controlling the disease and its subsequent consequences.

Suitability of ChatGPT as a Source of Patient Information for Screening Mammography.

ChatGPT3.5 and ChatGPT4 were released publicly in late November 2022 and March 2023, respectively, and have emerged as convenient sources of patient health education and information, including for screening mammography. ChatGPT4 offers enhanced capabilities; however, it is only available by paid subscription. The purported benefits of ChatGPT for health education need to be objectively evaluated. To assess performance differences, ChatGPT3.5 and GPT4 were used between 13 April and 29 May 2023 to generate breast screening patient information sheets, which were evaluated using the Patient Education Materials Assessment Tool for printed materials (PEMAT-P) and the CDC Clear Communication Index (CDC Index) Score Sheet; and benchmarked against gold standard content in BreastScreen NSW's patient information sheet. Mean scores were reported for comparison. GPT3.5 provided the appropriate tone and currency of information but lacked accuracy, omitting key insights: PEMAT-P understandability 68.0% (SD = 6.56) and actionability 36.7% (SD=20.4); CDC Index 58.8% (SD = 15.3). GPT4 was deemed superior to GPT3.5 but included several key omissions: PEMAT-P understandability 75.0% (SD = 17) and actionability 53.3% (SD = 11.54); CDC Index 66.0% (SD = 4.1). Both ChatGPT versions exhibited poor understandability and actionability and were unclear in their messaging. Those with poor health literacy will not benefit from accessing current versions of ChatGPT and may be further disadvantaged if they do not have access to a paid subscription. ChatGPT is evidenced to be an unreliable and inaccurate source of information concerning breast screening that may undermine participation and risk increased morbidity and mortality from breast cancer. ChatGPT may increase the demand on health care educators to rectify misinformation.

Implementation of an exact completing method of generation for face-milled spiral bevel gears with uniform depth taper

AbstractThis paper proposes an exact completing method of generation of face-milled spiral bevel gears with uniform depth taper. This method ensures localized bearing contact without kinematic transmission errors in both directions of rotation. Both sides of the tooth are generated simultaneously using the same set of basic machine tool settings. A tip relief on the tooth surfaces is the only required microgeometry modification to achieve a smooth transition of load between consecutive pairs of teeth. An analytical approach to determine the basic machine tool settings and select the grinding cutter parameters has been also developed. The selection of the nominal cutter radius follows the recommendations of Information Sheet AGMA 22849-A12. The basis for alignment error compensation has been also established. Tooth contact and stress analyses demonstrate the advantages and limitations of the proposed method, making it suitable for applications with higher power demands for the drive side than for the coast side.

Active Ingredient Prescribing in Australia: exploring pharmacists' experiences

AbstractBackgroundThe Active Ingredient Prescribing (AIP) mandate was introduced Australia‐wide on 1 February 2021. The AIP legislation makes the pharmacist a stakeholder who can provide valuable information to customers and patients.AimTo explore the experiences of community pharmacists with AIP legislation with a focus on attitude, health literacy, and medication safety.MethodSemi‐structured, in‐depth interviews were conducted and guided by the Theoretical Domains Framework (TDF). Transcripts were analysed using a deductive approach to categorise data and inductive thematic analysis to identify concepts and themes. Ethical approval was granted by the Griffith University Human Research Ethics Committee (Reference no: 2021/878) and the study conforms to the Australian National Statement on Ethical Conduct in Human Research. Informed consent from all participants was obtained via a study information sheet distributed to all potential participants and completion of written consent forms prior to participation in the study. Participants received gift cards as compensation for their time.ResultsSix pharmacists participated, and thematic analysis of collected data revealed three main themes. These included education, integration, and trust. Insights on patients' acceptance of their prescriptions and the expanded patient‐facing opportunities were highlighted. Participants' opinions leaned towards enhancing the smooth integration into the AIP process of other stakeholders like prescribers and regulatory bodies. Establishing multilevel communication between stakeholders and customers was pivotal to improving health literacy and medication safety. Pharmacists' views on process integration provided unique insight into the practical challenges with the AIP mandate. In addition, ‘trust’ in the prescriber enhanced patient acceptance of generic medicines.ConclusionThe study provided baseline evidence to show that the AIP mandate enhances health literacy and empowers patients to know the active ingredients in their medicines, which in turn supports medication safety. Examining the implementation of the AIP legislation facilitated a nuanced understanding of the effect that these AIP changes have on patients.

Trajectory and predictors of post-stroke depression among patients with newly diagnosed stroke: A prospective longitudinal study

BackgroundPost-stroke depression (PSD) is the most prevalent neuropsychological disorder among stroke patients, affecting approximately one-third of stroke survivors at any one time after a stroke. We identified between-person associations between post-stroke depression trajectories across 3 timepoints and predictors affecting trajectory classification among stroke patients. MethodsThis is a prospective longitudinal study using a convenience sample of 119 participants from 2 tertiary hospitals from March 2022 to September 2022. Clinical assessments and data collection were performed at diagnosis (T1), 3 months (T2), and 6 months (T3) after diagnosis. The instruments were Demographic and Disease Information Sheet and PROMIS-Depression 8a. Data were analyzed using SPSS 27.0 for descriptive statistics, logistic regression, and the Mplus program for growth mixture model analysis. ResultsTwo stroke survivors depression trajectory classes (Class 1, moderate level decreasing- [37.8 %], and Class 2, high level increasing- [62.2%]) were delineated. Class 1 experienced moderate depression post-stroke, with a smooth diminishing pattern at T2 and T3, while Class 2 had a higher baseline depressive score and a significant increase at T2 and T3. The best growth mixture model was Class 2 model (LMR, p=0.010, BLRT, p≤0.01, AIC=2611.934, BIC=2650.842, aBIC=2606.583, Entropy= 0.944). The logistic regression results revealed that Class 2 of depression trajectory had a significant association with a lower score on cognitive function (B=-5.29, 95%CI: -8.80, -1.78, p <0.05) compared with Class 1. The stroke type, marital status, and monthly income were predictors of the Class 2 depression trajectory group among stroke patients. Precisely, ischemic stroke is associated with lower risk of class 2 trajectory. ConclusionThe trajectory of post-stroke depression changes over time. This research has the potential to serve as a foundation for the assessment of high-risk stroke patients, the development of precise management programs, the implementation of risk stratification, and the enhancement of prognosis.

Biobanking rare gynaecological tumours – How harmonised is data collection?

IntroductionGYNOCARE, the European Network for Gynaecological Rare Cancer Research, set out to evaluate the current status of biobanks with access to rare gynaecological tumours, with a view to harmonising sample and data collection and associated consent, to facilitate collaborative cross-border research, enabling clinical trials and translational research. MethodsTwo digital surveys were formulated, one covering clinical and scientific parameters and one exploring ethical and regulatory issues around informed consent. ResultsData were analysed for 20 common responses, from 7 European countries. Tissue was the main sample type biobanked with 63 % also banking blood. Documentation of clinical data, treatment regimens and classification systems varied. Eighty percent collected pathological information. Most biobanks were linked to medical records but only one fifth with national registries.The Information Sheet covered governance, benefits/risks, sharing (mainly for non-profit research), return of results and data protection safeguards. Only 37 % informed patients about sample and data storage, although about half stored samples for an indefinite time. Pseudonymisation and Data Protection Officer approval were the prime data safeguards. Less than half explained the difference between anonymisation and pseudonymisation. Broad consent was the norm (84 %) and 95 % granted the right to withdraw consent. Three countries have Biobank legislation. ConclusionThese surveys provide a snapshot of the current state of biobanks and highlight divergences in the consent process and data management. More work is needed to understand what parameters are being gathered across more EU countries and thus harmonise the sample and data collection processes to facilitate cross-border research.

Sexual Knowledge, Attitude and Behaviors of Medical Students: A Cross-sectional Study

Introduction: Exposure to sexually explicit media influences the sexual knowledge, attitudes, and behavior of youth, so studying this among medical students is of utmost importance. Aim: To study sexual knowledge, attitudes, behaviors, and sources of influence among medical students. Methodology: A descriptive, cross-sectional, analytical, web-based study was conducted to assess sexual knowledge, attitudes, behaviors, and sources influencing sexuality in medical students via Google Forms. The form consisted of three parts: the first part was an information sheet and consent form, the second part included the participant’s sociodemographic data and the third part related to two study tools, the Sexual Knowledge and Attitude Questionnaire-II (SKAQ-II) and the sexual behavior and sources of influence scale. Result: A total of 300/950 (31.5%) medical students responded to the Google questionnaire. Their mean age was 20.43 ± 1.87 years (range: 18–26 years). The mean score for sexual knowledge and attitude was 24.35 ± 4.93 and 23.79 ± 4.87, respectively, which suggested that they had good sexual knowledge and liberal attitudes toward sexuality with female preponderance. As student’s academic year progresses, their sexual knowledge improves. There was a significant strong positive correlation between sexual attitude and knowledge with a Pearson correlation of r = 0.95, P = 0.004, which means the higher the knowledge, the better the attitude. Medical student’s engagement in sexual behaviors with self- and others was at age 18.45 years. The internet was the major source for getting information related to sexual behaviors for them, but they relied on doctors and friends for guidance. Conclusion: Medical students had adequate sexual knowledge, which was the reason for their liberal attitude toward sexuality. Their major source of sexual knowledge was the internet, although they confided in doctors for sexual doubts.

Views of research ethics committee members on end-of-participation communications for trial participants who stop taking part: a cross-sectional survey study

BackgroundGiving information to trial participants who stop taking part could support them through what can be a difficult process. We previously developed guidance around the ethical acceptability of such information provision, and about how trialists can develop suitable communication materials. There is limited evidence about what research ethics committees think of this issue, and limited guidance about what level of oversight they should have over the proposed communications, or post-consent participant communications generally. We conducted a survey of UK ethics committee members to address these points.MethodsThe survey was co-developed by public contributors and trialists who had previously worked together on the communications guidance. We asked respondents if they agreed with the general idea of informing participants who stop taking part, if they had ever been requested to review similar communications, and what level of ethics committee review they might recommend. The survey was primarily conducted online. It was reviewed by three ethics committee members before finalisation and shared directly with all UK ethics committee members. We analysed quantitative questions descriptively and used inductive analysis for open questions to identify common themes.ResultsNinety-one ethics committee members participated (nearly 10% of all UK members). The sample was similar to reported data about all members in terms of several personal characteristics. Most respondents (83%) agreed with our project’s rationale. Only 23% of respondents reported having been asked to review an end-of-participation information sheet before. Respondents gave various answers about the level of ethics committee review required, but most supported a relatively proportionate review process. Common concerns were about the risk of coercion or making participants feel pressured.ConclusionsOur survey suggests that ethics committee members generally support providing information to trial participants who stop taking part, if risks to participants are mitigated. We believe our guidance already addresses the main concerns raised. Our respondents’ lack of prior experience with end-of-participation information sheets suggests that participants are not getting information they want or need when they stop participating. Our results help clarify how ethics committee should oversee post-consent participant communications, but further guidance from research regulators could be helpful.

Exploring the Association between Sexual Orientation Beliefs and Ambivalent Sexism in Young Adults

This paper investigated the association between sexual orientation beliefs and ambivalent sexism in young adults. It was hypothesized that sexual orientation beliefs would correlate with and predicate ambivalent sexism, while there would be significant sociodemographic differences across the study variables. Selecting a cross-sectional (correlation) approach, a non-probability convenient sample of 221 young adults (Mage = 24.84, SDage = 5.82) was recruited. After filling out a detailed sociodemographic information sheet, the participants responded to original (English) versions of the Sexual Orientation Beliefs Scale (Arseneau et al., 2013) and the Ambivalent Sexism Inventory (Glick &amp; Fiske, 1996). The analysis revealed that all sub-scales of the Sexual Orientation Beliefs Scale (discreetness, naturalness, informativeness and homogeneity) had positive correlations with hostile sexism and benevolent sexism. Moreover, discreetness, informativeness, and homogeneity beliefs predicted hostile sexism, while only the homogeneity belief predicted benevolent sexism. The socio-demographic variables of age and education emerged as significant correlates. Muslims held stronger ambivalent sexism than non-Muslims but no difference was found in sexual orientation beliefs. Hostile sexism was higher in men and those from a nuclear family system. Benevolent sexism was higher in unemployed and non-heterosexual individuals. Lastly, the discreetness belief was stronger in men and heterosexuals. This study would be a valuable addition to the academic scholarship as it provided insights into the indigenous patterns of sexual orientation beliefs and their relationship with specific forms of sexism.

Exploring the User Acceptability and Feasibility of a Clinical Decision Support Tool Designed to Facilitate Timely Diagnosis of New-Onset Type 1 Diabetes in Children: Qualitative Interview Study Among General Practitioners.

Up to half of the children with new-onset type 1 diabetes present to the hospital with diabetic ketoacidosis, a life-threatening condition that can develop because of diagnostic delay. Three-quarters of Australian children visit their general practitioner (GP) the week before presenting to the hospital with diabetic ketoacidosis. Our prototype, DIRECT-T1DM (Decision-Support for Integrated, Real-Time Evaluation and Clinical Treatment of Type 1 Diabetes Mellitus), is an electronic clinical decision support tool that promotes immediate point-of-care testing in general practice to confirm the suspicion of diabetes. This avoids laboratory testing, which has been documented internationally as a cause of diagnostic delay. In this investigation, we aimed to pilot and assess the feasibility and acceptability of our prototype to GP end users. We also explored the challenges of diagnosing type 1 diabetes in the Australian general practice context. In total, 4 GPs, a pediatric endocrinologist, and a PhD candidate were involved in conceptualizing the DIRECT-T1DM prototype, which was developed at the Department of General Practice and Primary Care at the University of Melbourne. Furthermore, 6 GPs were recruited via convenience sampling to evaluate the tool. The study involved 3 phases: a presimulation interview, simulated clinical scenarios, and a postsimulation interview. The interview guide was developed using the Consolidated Framework for Implementation Research (CFIR) as a guide. All phases of the study were video, audio, and screen recorded. Audio recordings were transcribed by the investigating team. Analysis was carried out using CFIR as the underlying framework. Major themes were identified among three domains and 7 constructs of the CFIR: (1) outer setting-time pressure, difficulty in diagnosing pediatric type 1 diabetes, and secondary care considerations influenced GPs' needs regarding DIRECT-T1DM; (2) inner setting-DIRECT-T1DM fits within existing workflows, it has a high relative priority due to its importance in patient safety, and GPs exhibited high tension for change; and (3) innovation-design recommendations included altering coloring to reflect urgency, font style and bolding, specific language, information and guidelines, and inclusion of patient information sheets. End-user acceptability of DIRECT-T1DM was high. This was largely due to its implications for patient safety and its "real-time" nature. DIRECT-T1DM may assist in appropriate management of children with new-onset diabetes, which is an uncommon event in general practice, through safety netting.

4-H Volunteer Training Series: The ABCs of 4-H: A Primer for 4-H Volunteers

This information sheet is the introduction to the 4-H Volunteer Training Series (VTS). The series contains a wealth of information, from how to start a club, to planning field trips, to how to work with youth. This part was originally published in July 2014 and then revised in July 2018. It was updated in the summer of 2023 and is now revised in September 2024.

Development and validation of a new tool to assess quality of decision-making by older children and parents about research participation

ObjectiveEffective decision-making is crucial for children and young people's trial participation, but specific tools to measure it are lacking. The TRECA (TRials Engagement in Children and Adolescents) Decision-Making Questionnaire (DMQ) was developed to fill this gap and has been evaluated for reliability and validity MethodsWe created the TRECA Decision-Making Questionnaire, based on similar measures for adults, and recruited participants through seven Studies-Within-a-Trial (SWATs). Participants were randomly assigned to receive trial information either as a printed Participant Information Sheet or Multimedia Information, or both, and asked to complete the DMQ. We calculated item completion rates, item-remainder statistics and Cronbach’s Alpha, and conducted factor analysis. Results549 participants (433 parents/guardians, 116 older children) completed a DMQ. It had high completion rates and internal consistency (Alpha = 0.88 for parents/guardians and 0.84 for older children) and moderate to high inter-item correlations. The DMQ had a single factor accounting for 53 % of variance. ConclusionsThe TRECA DMQ is a useful tool for evaluating research participation decisions in older children, as well as parents and guardians. Practice implicationsOur study suggests that the TRECA DMQ can be used to assess the quality of decision-making about trials in parents, guardians and older children.

Effects of Digital Picture Books on Young Children Undergoing Cardiac Catheterisation and Their Family Caregivers: A Randomised Controlled Trial.

To assess the impact of digital picture books on preoperative anxiety, pain and sleep quality in young children undergoing cardiac catheterisation and the anxiety of their family caregivers. A randomised, single-blinded, two-arm, parallel-group controlled trial. Participants are young children aged 2-7 years with congenital heart disease scheduled for cardiac catheterisation and their family caregivers. They were enrolled at Fujian Medical University Union Hospital between September 2022 and July 2023. They were randomised to either a control group receiving usual care or an intervention group receiving digital picture book sessions. Anxiety and pain levels were assessed using standardised scales, and sleep quality was measured using actigraphy. The study included 64 pairs of young children and family caregivers. Digital picture books significantly reduced preoperative anxiety and bandage removal pain in children and anxiety in family caregivers. However, there was no statistical difference in sleep quality between the intervention group and the control group. Digital picture books prove to be an effective intervention for reducing anxiety and pain in paediatric cardiac catheterisation patients and anxiety of their family caregivers. The intervention did not affect sleep quality, suggesting the need for additional strategies to address this aspect of the hospital experience. This study demonstrated the effectiveness of digitally illustrated books in reducing preoperative anxiety and pain in young children and anxiety in family caregivers. Digital picture books offer a creative and engaging way to help children and their families cope with the stress and anxiety associated with medical procedures. Further research in this area may lead to the development of more innovative and effective interventions for paediatric patients and their family caregivers. The study's impact lies in its innovative approach to addressing the psychological and emotional challenges faced by young children and their family caregivers during the stressful experience of cardiac catheterisation. By demonstrating the efficacy of digital picture books in significantly reducing preoperative anxiety and postoperative pain, the research presents a non-pharmacological, accessible and engaging intervention that can be seamlessly integrated into existing healthcare practices. The findings have the potential to transform paediatric care by offering a safe, developmentally appropriate and cost-effective method to support the emotional well-being of children and their families, thereby enhancing the overall patient experience and clinical outcomes. Moreover, the study's emphasis on family caregiver involvement underscores the importance of a holistic approach to care that considers the needs of both the patient and their support system. Children and their family caregivers were invited to provide valuable input which has been critical to the development of the intervention. The participant information sheet and consent form, as well as the consent/recruitment process, were reviewed by a consumer advisor advocate from the pilot study. CONSORT. Chinese clinical trial registry: ChiCTR2200063973. Registered on 22 September 2022, https://www.chictr.org.cn/showproj.html?proj=132833.

FP5.14 - Enhancing Patient Communication in Surgical Care: an Audit of Practice at a DGH

Abstract Aims This audit aimed to evaluate current communication standards at a DGH (based on inpatient feedback) and assess the alignment with NICE Guidelines for improving the experience of care in adult NHS-services. The standards assessed included: providing clear information on diagnosis, oral and written communication, and communication in the presence of family or next of kin. Methods Inpatient feedback on surgical wards was collected to assess guideline adherence, with a pre-intervention survey designed to assess opinions before implementing an intervention. Two assessment cycles were conducted, with 12 responses in Cycle 1 (1-15 Nov 2023) and 13 responses in Cycle 2 (16-30 Nov 2023). The intervention included providing clear written information on imaging results and ongoing plans, and encouraging patients to use an information sheet throughout their admission, which could also be relayed to family members. Results Pre-intervention data revealed a diverse age distribution, predominantly in the 55-64 age group. Understanding of diagnosis varied pre-intervention but showed improvements post-intervention. Post-intervention, the majority (n=9) felt the information was appropriately pitched. Thirteen respondents received accessible information, finding the universally distributed information sheet helpful. A written response highlighted its utility in explaining clinical information to families. Healthcare professionals received improved 'clarity' and 'helpfulness' ratings post intervention, indicating positive outcomes. Conclusions Effective communication is integral to exceptional patient care. This audit underscores the potential to enhance patient understanding, alleviate concerns, and improve communication in surgical settings. The intervention, a simple information sheet, proved effective and emphasised the need for accessible, clear and standardised patient communication.

Lived-in Experience Among Caregivers of Autistic Children: A Qualitative Study from South India

Background: Autism is a developmental disorder that impairs the skills related to behavior, communication, interaction, and learning. This study was undertaken to understand the difficulties faced by caregivers in various aspects of life while taking care of children with autism and their unique life experiences. Methods: After obtaining ethical approval, the study was conducted in a tertiary care hospital in Bangalore, India. An informed consent and a subject information sheet were taken to obtain permission from the subjects. A baseline proforma was prepared for collecting the demographic data for both autistic children and the caregivers. An in-depth, face-to-face, semi-structured interview that consisted of around 10 questions was conducted for 30 minutes. The interview was recorded, later transcribed verbatim, and extracted into specific themes and subthemes. Results: The lived-in experiences throw light on many emotional, social, psychological, and physical distress the caregivers go through on a day-to-day basis. The daily hassles of every caregiver are unique and challenging. Five themes and corresponding subthemes were extracted as follows: emotional meltdown, change in family dynamics, spiritual transition, perceived social burden, and perception of a child’s future. Conclusion: The caregivers of children with autism faced various challenges such as physical and emotional turmoil, financial constraints, and the deprivation of a healthy social life almost every day. Interventional measures such as nurse-led clinics, counseling measure, and planning training sessions for nurses to deal with the various issues faced by the caregivers could be taken up to address the growing concerns of caregivers of children with autism.

Urinary tract infection among people living with human immunodeficiency virus attending selected hospitals in Addis Ababa and Adama, central Ethiopia.

Urinary tract infections (UTIs) and antibacterial resistance (ABR) are important public health problems, but they are not well-studied among people living with human immunodeficiency virus (PLHIV) globally, especially in low-income countries. Therefore, it is important to regularly measure the extent of UTIs and ABR in the most susceptible populations. This study aimed to investigate the prevalence of UTIs, associated factors, bacterial causal agents, and their antibiotic susceptibility profile among PLHIV in central Ethiopia. A hospital-based cross-sectional study was conducted to recruit 688 PLHIV by a simple random sampling method. Background information was gathered through interviews, while clinical information was gathered from recent information sheets of patient charts using organized, pretested, and validated study tools. Midstream urine was collected aseptically and transported to the Microbiology Laboratory of Aklilu Lemma Institute of Pathobiology within 4 h of collection, maintaining its cold chain. Standard conventional microbial culture methods and matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) mass spectrometry were used to identify the bacterial isolates at the species level. Kirby Bauer's disk diffusion method was used to determine the antibiotic susceptibility profile of the bacterial isolates based on the interpretation guidelines of the Clinical Laboratory Standard Institute. Logistic regression models were used to examine factors associated with the occurrence of UTIs among PLHIV attending selected hospitals in Addis Ababa, and Adama. Out of 688 PLHIVs involved in the current study, 144 (20.9%) were positive for UTIs, whereas the majority were asymptomatic for UTIs. In the multivariable logistic regression analysis, only HIV RNA ≥ 200 copies/ml [AOR = 12.24 (95% CI, 3.24, 46.20), p < 0.01] and being symptomatic for UTIs during the study period [AOR = 11.57 (95% CI, 5.83, 22.97), p < 0.01] were associated with the occurrence of UTIs. The dominant bacterial species isolated were Escherichia coli (E. coli; n = 65; 43%), followed by Enterococcus faecalis (E. faecalis; n = 16; 10.6%) and Klebsiella pneumoniae (K. pneumoniae; n = 11; 7.3%). Over half of the E. coli isolates were resistant to antibiotics such as gentamicin (GM; n = 44; 67.7%), amikacin (AN; n = 46; 70.8%), nalidixic acid (NA; n = 42; 64.6%), ciprofloxacin (CIP; n = 40; 61.5%), and azithromycin (AZM; n = 45; 69.2%). All of the K. pneumoniae isolates (n = 11; 100%), (n = 6; 54.5%), and (n = 7; 63.6%) were resistant to [amoxicillin as well as amoxicillin + clavulanic acid], ceftriaxone, and sulfamethoxazole + trimethoprim, respectively. All the Staphylococcus aureus (S. aureus) isolates were resistant to cefoxitin, which implies methicillin-resistant S. aureus (MRSA). The high prevalence of UTIs and antibiotic resistance revealed in the current study needs public health interventions such as educating the population about preventive measures and the importance of early treatment of UTIs. Our findings also highlight the need to provide UTI screening services for PLHIV, and healthcare providers should adopt antibiotic stewardship programs to promote and ensure their appropriate and judicious use.

A protocol for an open-label randomized parallel group clinical study on non-alcoholic fatty liver disease (NAFLD)

The primary objective of this study is to evaluate the efficacy of the combined effect of Agnideepan and Vyadhipratyaneek Chikitsa on the Fatty Liver Index (FLI) score in patients with Non-Alcoholic Fatty Liver Disease (NAFLD). Secondary objectives include assessing the impact of combined chikitsa on Agni, lipid profile, body weight, waist circumference, and BMI. The study also aims to evaluate the effects of Vyadhi Pratyaneekachikitsa on changes in the FLI, lipid profile, body weight, waist circumference, BMI, and Agni, as well as the impact of Agni Deepanchikitsa on these parameters. Additionally, the quality of life of NAFLD patients will be evaluated using the SF36 questionnaire. Patients diagnosed with NAFLD will be selected from the outpatient department of CARICD, now renamed the Central Ayurveda Research Institute in New Delhi. Patient information sheets and consent forms will be provided to all willing participants. Screening will be conducted, and suitable patients will be randomized using a computer-generated chart. Trial formulations will be prescribed according to a set schedule, and patients will be called for follow-up visits accordingly. It is expected that the combined treatment of Agnideepan and Vyadhipratyaneek Chikitsa will be more effective than Vyadhipratyaneek Chikitsa alone in managing NAFLD. This study aims to explore the effectiveness of Ayurveda interventions in managing NAFLD through a disease-specific approach to precisely correct RaktavahaSrotodushti with Yakrt involvement and a general approach aimed at correcting metabolism. This dual approach highlights the role of multiple therapeutic targets in disease management tailored to patient-specific factor.