Hospital Ethics Research Articles

An initial investigation into the use of virtual reality (VR) glasses on self-reported pain perception during mammography

ObjectivePain is one of the causes of refraining from mammography. This study aimed to investigate the use of virtual reality (VR) glasses for management of pain during mammography. MethodsFifty subjects who were referred to the radiology unit for mammography screening were invited to participate in the study. The study was approved by the hospital's ethics committee and participants provided written and oral informed consent. Craniocaudal (CC) and mediolateral oblique (MLO) views of the right breast were first acquired, followed by left CC and MLO mammographic views with the VR glasses on. After the examination, participants completed a questionnaire including a validated visual analog scale (VAS) scoring system to analyze pain scores. Data were analyzed using Spearman's rho and the Kruskal-Wallis test, as well as the Bland–Altman analysis to examine discrepancy. ResultsThe association of the right breast pain score with the parameters of age, breast density, previous mammography, family history of breast cancer, educational attainment, and employment status was examined using a correlation test. All the parameters showed no significant correlation with the right breast pain score except age (p: 0.016, correlation coefficient: −.340). Apart from that this study demonstrated no significant correlation between the perceived pain experienced during mammography and the utilization of VR technology. ConclusionThe findings indicate an inverse correlation between participant's age and pain perception during mammography examinations. Moreover, the utilization of Virtual Reality (VR) did not demonstrate efficacy in reducing pain perception.

The Self Who Meets the Other: Deconstructing the “Well-Intentioned” Researcher Through an Ethic of Hospitality

The pursuit of anti-oppressive, cross-racial research has become ubiquitous in educational settings. Although some attention has been given to the complexities such an endeavor involves, more intricate and profound aspects that undergird such projects are revealed when examined through the lens of an ethic of hospitality. Based on a case-study focused on the experiences of Black refugee students in Manitoba, this article deconstructs the research journal that I kept throughout that project. Four overarching and intertwined themes are evidenced and discussed: the methodological decisions I had to make along the study, personal ambivalences experienced, feelings of powerlessness, and the (explicit) implications of my White identity. As such, the research journal here analyzed not only reveals the aporetic nature of hospitality but also several ethical complexities involved in the pursuit of hospitable, anti-oppressive research in a cross-racial setting, which have not received enough attention in current literature. La recherche anti-oppressive et interraciale est devenue omniprésente dans les milieux éducatifs. Bien qu'une certaine attention ait été accordée aux complexités qu'une telle entreprise implique, des aspects plus complexes et plus profonds qui sous-tendent de tels projets sont révélés lorsqu'ils sont examinés à travers le prisme d'une éthique de l'hospitalité. Basé sur une étude de cas centrée sur les expériences d'étudiants réfugiés noirs au Manitoba, cet article déconstruit le journal de recherche que j'ai tenu tout au long de ce projet. Quatre thèmes primordiaux et entrelacés sont mis en évidence et discutés : les décisions méthodologiques que j'ai dû prendre tout au long de l'étude, les ambivalences personnelles vécues, les sentiments d'impuissance et les implications (explicites) de mon identité blanche. Ainsi, le journal de recherche analysé ici révèle non seulement la nature aporétique de l'hospitalité, mais aussi plusieurs complexités éthiques liées à la poursuite d'une recherche hospitalière et anti-oppressive dans un contexte interracial, qui n'ont pas fait l'objet d'une attention suffisante dans la littérature actuelle.

Frequency of side effects experienced in two different NIM-EMG tubes used in thyroid and parathyroid surgery; a prospective observational study

BackgroundIn this study, we observed the frequency of side effects encountered when the neural integrity monitor electromyogram endotracheal tube (NIM-EMG-ETT) was used in thyroidectomy and parathyroidectomy surgeries.MethodsAfter obtaining hospital ethics committee approval, 239 cases affiliated with the American Society of Anesthesiologists (ASA II-IV) who used NIM EMG tubes in thyroid and parathyroid surgery were included in the prospective observational study. Tube and patient-related complications encountered with two different NIM EMG-ETT (silicone and polyvinyl chloride-PVC) were recorded.ResultsThe average age of the patients is 49.50 ± 13.44 years, the average BMI is 28.25 ± 4.91 kg/m2, the median surgery time is 115 (32–475) minutes, 75.7% are women, 97.5% are ASA II. Additional diseases other than thyroid and parathyroid problems were present in 77.3%. Thyroidectomy was performed in 73.2% of the patients. In our study, only 0.8% of patients with transient recurrent laryngeal nerve RLN paralysis were observed in thyroid and parathyroid surgeries performed using NIM-EMG tubes, 3 patient already had nerve involvement in the preoperative period. The most common complication was loss of stimulation response related to tubes and patient-related ventilation failure. There was no difference between the complications of silicone and PVC tubes except for irregular EMG response.ConclusionsThere was no significant difference in side effects other than irregular EMG response in the two different tubes we used in our study. It was observed that prolonging the surgical time increased the risk of irregular EMG response. It should not be forgotten that no matter which NIM-EMG tube is used, additional risks are encountered during the intubation and extubation process. In order to avoid negative consequences, it is necessary to follow the usage rules recommended by the manufacturer when using NIM-EMG tubes.

P-712 A national survey of women’s perspectives and experiences of pursuing donor eggs

Abstract Study question What are the experiences of women who consider a donor egg, and the outcomes of those who receive donor eggs for conception? Summary answer Of 255 respondents, 59 women (23.1%) were formally placed on a donor egg waitlist, despite 80.6% respondents considering donor eggs with an IVF clinic (166/206). What is known already There is a shortage of donor eggs worldwide. Oocyte donation is a treatment option that is increasingly used for infertile women, as seen through the percentage of patients undergoing IVF who are over 40 years. Previous international studies report oocyte donation recipients to be predominantly aged 34-40 years, white, nulliparous, well-educated, married and financially secure. Although there are records in Australia for the number of donor and recipient cycles undertaken, there is no published data on the number of patients considering a donor oocyte, or on oocyte donor waitlists. In Australia egg donation is altruistic, non-commercial and not anonymous. Study design, size, duration A 52-point online survey was distributed via social media to women in Australia who had ever considered or pursued donor eggs, or come to the end of their own IVF treatment. The survey was sent to all clinical members of the Fertility Society of Australia and New Zealand (FSANZ) and available on the Victorian Assisted Reproductive Technology Authority (VARTA) website. The survey was open from 1 February to 30 April 2023. Hospital ethics approved. Participants/materials, setting, methods A cross-sectional, anonymous, online survey of women in Australia who were potential egg donor recipients. Survey questions included demographics, potential donor egg recipient preferences, IVF clinic experiences, barriers, any impact of the COVID-19 pandemic, attitudes around the reimbursement for donor eggs, and fertility costs already incurred. Responses were collected via the Qualtrics XM platform. Statistical analysis for quantitative data was analysed using Microsoft 365 Excel. Qualitative coding performed on the commentary in free text fields. Main results and the role of chance This study identified a large gap between those who considered a donor egg (80.6%), pursue a donor egg on an IVF clinic waitlist (23.1%), and those who actually received a donor egg. Of the 59/255 women who were placed on an oocyte donor waitlist at an IVF clinic in Australia, less than a quarter (23.1%) received a donor egg (13/58), with a pregnancy and live birth rate of 76.9% and 61.5%, respectively. Thus, of those that were on an Australian waitlist, one quarter received donor eggs, with over half of these recipients having a live birth. ‘Women preferred donor eggs from Australia than overseas, preferred an unknown donor from an IVF clinic program, and wished to know source information for themselves and children in the future. Attitudes towards financial reimbursement were generally positive towards compensation. Barriers to pursuing donor eggs included grief of loss of own fertility, cost, availability and time. When on an Australian donor egg list, many respondents still looked at other sources of donor eggs in Australia and overseas. Reasons women came off an Australian donor egg waitlist included receiving donor eggs and donor embryos elsewhere, including from overseas, as well as advancing age and expense. Limitations, reasons for caution Risk of respondent selection bias of those who chose to response to a public survey, with incomplete data for some respondents. Given survey in English, may have underrepresentation of some cultural groups and sampling a limited range of women from diverse social, economic and religious settings. Wider implications of the findings In this first paper of potential egg recipients’ preferences in the Asia-Pacific region, we have identified a gap where demand for donor eggs exceeds local supply. A majority of potential recipients would support financial reimbursement for eggs already cryopreserved by women initially freezing for own elective purposes. Trial registration number not applicable

Preventing adverse events during paediatric cancer treatment: protocol for a multi-site hybrid randomised controlled trial of catheter lock solutions (the CLOCK trial)

IntroductionCentral venous access devices (CVADs) are commonly used for the treatment of paediatric cancer patients. Catheter locking is a routine intervention that prevents CVAD-associated adverse events, such as infection, occlusion...

Multicomponent supervised tele-rehabilitation versus home-based self-rehabilitation management after anterior cruciate ligament reconstruction: a study protocol for a randomized controlled trial

IntroductionOur study aims to assess the effectiveness of multicomponent supervised tele-rehabilitation compared to home-based self-rehabilitation management in patients following anterior cruciate ligament reconstruction (ACLR).MethodsThe current study is designed as a single-center, single-blinded, randomized controlled, two-arm trial. Participants will be randomized and allocated at a 1:1 ratio into either a multicomponent supervised tele-rehabilitation group or a home-based self-rehabilitation group. All participants receive uniform preoperative education through the HJT software. Participants in the intervention group undergo multicomponent supervised tele-rehabilitation, while those in the control group follow a home-based self-rehabilitation program. All the participants were assessed and measured for the included outcomes at the outpatient clinic before the procedure, and in 2, 4, 8, 12, and 24 weeks after ACLR by two assessors. The primary outcome was the percentage of patients who achieve a satisfactory active ROM at the 12 weeks following the ACLR. The satisfactory active ROM was also collected at 2, 4, 8, and 24 weeks after ACLR. The secondary outcomes were active and passive range of motion (ROM), pain, muscle strength, and function results.Registration detailsEthical approval has been obtained from the West China Hospital Ethics Committee (approval number 2023−1929, December 2023). The trial has been registered on ClinicalTrials.gov (registration number NCT06232824, January 2024).

Management of Ischemic Stroke in a Tertiary Care Hospital in Khyber Pakhtunkhwa: Existing Status and Prospective Opportunities.

Background and objective Khyber Pakhtunkhwa is the third largest province of Pakistan by population and has a high incidence of ischemic stroke. We evaluated all patients who presented to the largest tertiary care facility in the province to learn about the current trends in the management of ischemic stroke and explore future opportunities in this regard. Materials and methods This prospective observational research was carried out at the Lady Reading Hospital-Medical Teaching Institute (LRH-MTI), Peshawar, in the province of Khyber Pakhtunkhwa (KP). The hospital's ethics committee granted the required permissions for the research. Any patient with an ischemic stroke diagnosis, regardless of age, met the inclusion criteria if their diagnosis was confirmed by clinical assessment, imaging (such as CT or MRI), or both. The clinical parameters that were evaluated included the duration since the patient's reported onset of symptoms, the patient's first mode of transfer to the hospital (such as ambulance, private vehicle, or other means), and the date and time of admission to the hospital. A structured database containing the data was utilized, and IBM SPSS Statistics for Windows, Version 25 (released 2017; IBM Corp., Armonk, New York, United States) was used for statistical analysis. Results One hundred fifty-six stroke patients were diagnosed throughout the study period, with 76 of them having an ischemic stroke, accounting for 49% of all stroke cases. Approximately 43% (n = 33) of the patients were from Peshawar, with the remaining patients coming from adjacent districts. There was only a small percentage (19%, n = 15) of patients who were eligible for any thrombolytictherapy, and the majority (93%) were brought by private vehicles. There was a significant association between age and arrival in the emergency room (p = 0.003). Conclusion The study reveals subpar ischemic stroke management in Khyber Pakhtunkhwa, requiring coordinated efforts, modernization of treatment methods, and increased public awareness to improve patient outcomes.

Comparing ranibizumab, dexamethasone implant, and combined therapy for macular edema secondary to branch retinal vein occlusion: a clinical trial.

Macular edema (ME) is a common complication following branch retinal vein occlusion (BRVO) and is also the main reason for visual impairment. This study aimed to compare the efficacy and safety of intravitreal ranibizumab (IVR) or dexamethasone implant (IDI) monotherapy, as well as the combination of IVR and IDI injections, in patients with ME secondary to branch retinal vein occlusion (BRVO). This multicenter, prospective, and comparative study included 292 patients with unilateral ME involvement (total of 292 eyes) secondary to BRVO. The patients were randomly assigned to three groups and followed up for 12months. Patients in group 1 (n = 96) were treated with 3-dose loading IVR injections followed by a pro re nata (PRN) regimen. Patients in group 2 (n = 98) received IVR combined with IDI injection, followed by IVR PRN regimen. Patients in group 3 (n = 98) were treated with IDI injection, followed by repeated IDI injection based on clinical necessity. Best corrected visual acuity (BCVA), central retinal thickness (CRT), complications, and frequency of injections were recorded and compared between the three groups. At baseline, the three groups did not differ in age, gender, duration of ME, BCVA, IOP, and CRT (P > 0.05). Mean number of total injections per eye within 12months were 7.1 ± 2.3 (range 4-9) in group 1, 3.7 ± 1.5 (range 2-6) in group 2, and 1.8 ± 0.4 (range 1-3) in group 3. There was a statistical difference in the number of injections between group 1 and group 2 (P = 0.037). Eyes in group 3 received fewer injections than those in group 2, but the difference was not statistically significant (P = 0.052). BCVA improvement and CRT reduction were achieved in all groups and there was no significant difference between the three groups at the end of the 12th month. However, IOP elevation and cataract progression were more frequent in group 3, especially in those patients who received repeated IDI injections. Three therapeutic regimens had comparable efficacy in treating ME secondary to BRVO. Combination therapy had an advantage in maintaining good effect with fewer re-injections and complications. The study complied with the principles of the Declaration of Helsinki and was approved by Xi'an Aier Ancient City Eye Hospital, Xi'an Aier Eye Hospital, and Xianyang Aier Eye Hospital ethics committees (2022SF-367).

Factors Associated With Mosaicism in Human Embryos: A Retrospective Study.

Objective This study aims to identify factors associated with mosaicism in human embryos at Hung Vuong Hospital. Methods We performed a retrospective analysis of data from 2018 to 2022, approved by the Hung Vuong Hospital Ethics Committee (CS/HV/23/15). We analyzed variables such as demographic characteristics, clinical measurements, and in-vitro fertilization (IVF) cycle outcomes to investigate their relationship with embryo mosaicism. Results A total of 73 couples undergoing IVF with preimplantation genetic testing (PGT) were included in the analysis. Among 308 embryos, 98 (31.8%) were mosaic, 124 (40.3%) were euploid, and 86 (27.9%) were aneuploid. Univariable analysis revealed that female age was significantly associated with increased odds of mosaicism (oddratio(OR) = 1.11, 95% confidence interval(CI): 1.04 - 1.19, p = 0.003). Male age demonstrated a marginal association with mosaicism (OR = 1.05, 95% CI: 1.00 - 1.11, p = 0.07). Other factors, including body mass index (BMI), anti-Mullerian hormone (AMH) levels, blood types, and sperm quality, were not significantly associated with mosaicism. In the multivariable analysis, controlling for both female and male age, female age showed a trend toward significance (OR = 1.12, 95% CI: 1.02 - 1.23, p = 0.02), while male age showed no significant effect (OR = 0.99, 95% CI: 0.92 - 1.06, p = 0.75). Conclusions The findings suggest that female age is a critical factor influencing the occurrence of mosaicism in embryos. Further research is needed to fully understand the mechanisms underlying mosaicism in human embryos.

STEM-08. ANGIOGENESIS IN PEDIATRIC CHOROID PLEXUS PAPILLOMAS

Abstract BACKGROUND Choroid plexus papillomas (CPP) are rare brain tumors that tend to occur in very young children. Although most of them are curative with surgical resection, a subset of them has propensity for tumor recurrence, progression, and metastasis. Moreover, surgery can be technically difficult due to their deep locations and high vascularity. In-depth mechanisms of their biology remain poorly understood. Separately, the process of angiogenesis has been implicated in several cancers. To date, there has been no previous study focused on CPP and angiogenesis. This study aims to explore and ascertain the existence of angiogenesis in CPP. METHODS This is a study approved by the hospital ethics review board. Cerebrospinal fluid (CSF) and CPP tumor samples are collected at the time of surgery. A multiplex immunoassay panel is used to measure cytokine concentrations in the CSF samples. Identified cytokines of interest are input into online platforms to assess for protein-protein interaction pathways. Concurrently, patient-derived primary cell cultures and their supernatants are derived from CPP samples. A targeted proteome blot array and HUVEC tubule formation assays are used to validate clinical and in silico findings. RESULT CSF profiling showed higher expression of MCP-1, MMP-1, IL-2, TNF-ɑ, TRAIL and CD40-L in CPP patient samples versus non-tumor controls. Next, in silico assessment via STRING and BioGRID platforms report that these cytokines are associated with endothelial cell regulation. This is clinically relevant as we are aware that the endothelium has important functions in the regulation of angiogenesis. Using an angiogenesis-focused approach, CPP-derived cell lines and supernatants showed congruently higher expression of MCP-1, MMP-1 and TNF-ɑ. Next, tubule formation was observed in HUVEC cultures where conditioned CPP cell culture media was added. CONCLUSIONS Based on our preliminary findings, this proof-of-concept study demonstrates potential to explore the role of angiogenesis in CPP for better disease understanding.

Investigating the Relationship Between Clinical Characteristics, Mental Health, and Vascular Function in Minor Ischemic Stroke or Transient Ischemic Attack Patients.

Over the past decade, there has been extensive research exploring the relationship between vascular health and mental well-being, encompassing aspects such as mood and cognition. However, there is a notable gap in research focusing on the mental and vascular conditions of minor ischemic stroke or transient ischemic attack (TIA) patients, particularly within the Thai population. To investigate the clinical characteristics and mental issues related to vascular functions in patients who have experienced a minor ischemic stroke or TIA. This study, approved by the Buriram Hospital Ethics Committee (IRB: BR0033.102.1/8), adhered to the guidelines of the Helsinki Declaration and obtained informed consent from all participants. A prospective cross-sectional study was conducted at Buriram Hospital, a government regional hospital located in Buriram province, Thailand, involving twenty-three participants diagnosed with minor ischemic stroke or TIA. Measurements included clinical characteristics, Hospital Anxiety and Depression Scale-part Anxiety (HADS-A), Hospital Anxiety and Depression Scale-part Depression (HADS-D), mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), flow-mediated dilation (FMD), and brachial-ankle pulse wave velocity (baPWV). Linear regression analysis was employed to investigate the factors associated with vascular function (FMD and baPWV). The factor related to FMD was HADS-D (β = -0.5, 95% CI -0.33 to -0.04). Factors associated with baPWV included age (β = 0.51, 95% CI 5.05 to 39.50) and the duration of minor ischemic stroke or TIA (β = 0.48, 95% CI 25.41 to 290.99). FMD shows a connection with depressive symptoms in patients with minor ischemic stroke or TIA. Therefore, it is important to detect and provide appropriate treatment for depressive symptoms in these patients, as it may lead to improvements in vascular function and better cerebrovascular outcomes.

An Ethics Committee’s Evaluation of Normothermic Regional Perfusion (NRP) in 2018–Unsatisfactory Answers Then—and Now

An adult university hospital ethics committee evaluated a proposed TA-NRP protocol in the fall of 2018. The protocol raised ethical concerns about violation of the Uniform Determination of Death Act and the prohibition known as the Dead Donor Rule, with potential resultant legal consequences. An additional concern was the potential for increased mistrust by the community of organ donation and transplantation. The ethics committee evaluated the responses to these concerns as unable to surmount the ethical and legal boundaries and the ethics committee declined to endorse the procedure. These concerns endure.

Genetic testing in cancer care: An assessment of current practice in Africa.

e13784 Background: Genetic testing provides forprecision oncologic intervention, improving outcomes and minimizing traditional cytotoxicity. It has caused a dramatic change in the oncology landscape but remains underutilized in Africa. Data on genetic alterations associated with cancer in people of African descent continue to be inadequate due to multi-layered factors such as availability and cost of testing, provider awareness and knowledge, and availability and cost of targeted therapy. With cancer projected to be the leading cause of mortality in Africa within the next two decades, identifying the current patterns of testing and reasons for low uptake is crucial for developing strategies to improve cancer care and outcomes in Africa. This study aimed to map the current utilization pattern of cancer genetic testing among oncologists in Africa. Methods: An online cross-sectional survey was administered to oncologists practicing in Africa. Responses were collected between September 2023 and January 2024 following IRB approval from the Lagos University Teaching Hospital Health Research and Ethics Committee. Surveys were administered in English and French. Results: 245 oncologists across 28 African countries participated in this study. The mean age of respondents was 41.6 (SD: 8.3), with 64.5% being male and Nigerians comprising the largest proportion (33.0%). The majority of respondents practice in public/government-owned facilities (44.1%), and 64.5% held consultant/attending positions. Survey findings showed that 69.8% of oncologists lacked confidence in understanding/interpreting genetic test results, 93.5% expressed the need for assistance in interpreting results, and 64.1% were unable to discuss findings confidently with patients. The most ordered test was BRCA1/2 (47.3%), while ABC and RB1 genes were the least commonly ordered (0.008% and 0.02%, respectively). The primary reason for ordering genetic tests (63.3%) was the potential to guide treatment planning. However, 54.7% reported not referring any patients for genetic testing in the past year. Barriers to testing included the high cost of tests (78%) and targeted therapies (60.4%). Furthermore, 67.8% of respondents lacked previous formal training in cancer genetics with nearly all respondents (97.6%) expressing interest in formal training and a preference for online courses (71.8%). Conclusions: This survey highlights the critical need to develop the capacity for understanding cancer genetic testing and targeted treatment options among oncologists in Africa. To optimize uptake, strategies must be developed to reduce testing costs through resource pooling and to reduce the high cost of targeted treatment. Oncologists should be encouraged to prioritize testing that guides actionable targets to promote the uptake of targeted treatment options in Africa.

The clinical significance of PRMT8 expression in esophageal squamous cell carcinoma and the influence on prognosis.

e16066 Background: Protein arginine methyltransferase 8 (PRMT8), a member of protein arginine methyltransferases, is an enzyme catalyzing the methylation of arginine residuals of histones and non-histone proteins to serve as one of many critical post-translational modications (PTMs). Esophageal squamous cell carcinoma (ESCC) is the third most common cancer type of the gastrointestinal tract with poor prognosis. Abnormal arginine methylation modifications are closely associated with the development of ESCC and can exert oncogenic effects by regulating a variety of cellular processes. However, the expression of PRMT8 in ESCC and its influence on prognosis is currently unknown. Methods: After passing the application and obtaining the approval of the hospital ethics review committee and obtaining the informed consent of all patients and their families, we collected 46 cases of renal cell carcinoma diagnosed in the Fourth Hospital of Hebei Medical University from 2018 to 2023, and postoperative pathological reports of all patients confirmed to be ESCC. We followed the selected patients and obtained complete data. All the pathological specimens of the selected patients were resectioned and then subjected to immunohistochemical examination to observe the expression differences of PRMT8 in ESCC, and parallel semi-quantitative analysis. Finally, the data of the patients were statistically built. Results: PRMT8 is mainly stained on the plasma membrane of tumor cells. The difference in expression levels between ESCC and normal tissue adjacent to the cancer was statistically significant (P < 0.01). This study found that the patient’s gender, age, tumor side have no correlation with the expression levels of PRMT8 (P > 0.05), while the three indicators of tumor size, TNM stage, and lymph node metastasis are positively correlated with the expression levels of PRMT8 and the difference is statistically significant (P < 0.01). Moreover, the positive staining of PRMT1 in ESCC was significantly correlated with poor prognosis of ESCC patients. Conclusions: The expression of PRMT8 is highly expressed in ESCC and associated with aberrant clinicopathological characteristics and poor prognosis. PRMT8 is a potential target for the stratification and treatment of ESCC.

What Factors Contribute to Ethical Problems in Patient Care? A Scoping Review and Case Series of Clinical Ethics Consultations.

A scoping review of ethical risk factors in patient care and a CEC case series were conducted, analyzing the documentation (consultation reports, feedback forms, electronic medical records) of 204 CECs from 2012 to 2020 at a somatic and a psychiatric university hospital in Basel, Switzerland. Ninety-nine ethical risk factors were identified in nine articles, related to four risk areas: patient (41), family (12), healthcare team (29), and system (17). Eighty-seven of these risk factors were documented at least once in the CEC case series. The most prevalent risk factors in the consultations studied were patient vulnerability (100%), missing or unclear hospital ethics policy (97.1%), shift work (83.3%), lack of understanding between patient and HCP (73.5%), poor communication (66.2%), disagreement between patient and HCP about care (58.8%), and multiple care teams (53.4%). The prevalence differed significantly by medical specialty. There are highly prevalent ethical risk factors at all levels of clinical care that may be used to prevent ethical problems. Further empirical research is needed to analyze risk ratios and to develop specific risk profiles for different medical specialties.

Effectiveness of Teaching Communication Skills in Undergraduate Curriculum at Defence Services Medical Academy Myanmar: Mixed Qualitative and Quantitative Study

Introduction: Good communication is the cornerstone of quality healthcare and it should be patient centered. Communication skills is taught and assessed with surrogates in undergraduate training. This study aimed to determine the effectiveness of communication skills taught in undergraduate period in reality. Methodology: It was a combined qualitative and quantitative methods. For qualitative assessment, phenomenology was used. Informal focus group semi-structured interview was done to groups of interns who had completed internship at medical wards. The responses were analyzed interpreted and classified; thematic analysis was done. For quantitative assessments, open ended questions were set by experts in medical education. The questions were answered anonymously; they were grouped into same themes. This study was approved by ‘Hospital Research and Ethics Committee’ of No(1) Defence Services General Hospital. Informed consent was taken from each intern. Results: A total 20 interns were included. Four themes were formed after thematic analysis: (1) the extent of applicability of communication skills they were taught in undergraduate days;(2) self-admitted confidence and degree of satisfaction; (3) the challenges/gaps they faced in reality; and (4) their suggestions on undergraduate teaching to fill the gaps. All interns admitted that the communication skills they taught was 100% applicable in practice. And they were confident out of proportion to their medical experience. They were satisfied with communication skills they were taught in undergraduate days. The challenges faced were as follows; difficulty in understanding volume and clarity of language when dealing with some nationality; low education level of patients leading to difficulty in understanding the information they have given; difficulty in getting trust from patient being youngest doctor in the team; and, taking long time due to emotional reaction of patient in breaking bad news. They admitted that they need to fill their knowledge gaps to answer the questions raised by patients particularly in explanation of diagnosis and management. They realized the importance of facial expression and tone of voice to express sympathy and empathy especially in breaking bad news. To improve communication skills in practice, they suggested to teach with real patients with real scenario. Conclusion: Teaching communication skills in undergraduate period was effective. The interns had good self-reported confidence. The interns need more training and self-directed learning. The challenges faced by interns were acceptable/logical. We should find better teaching method/media in undergraduate teaching to promote communication skills.

Reinforcement of pimobendan with guideline-directed medical therapy may reduce the rehospitalization rates in patients with heart failure: retrospective cohort study

BackgroundPimobendan reportedly improves the subjective symptoms of heart failure. However, evidence of improved prognosis is lacking. This study aimed to determine whether reinforcing guideline-directed medical therapy (GDMT) improved rehospitalization rates for worsening heart failure in patients administered pimobendan.MethodsA total of 175 patients with heart failure who were urgently admitted to our hospital for worsening heart failure and who received pimobendan between January 2015 and February 2022 were included. Of the 175 patients, 44 were excluded because of in-hospital death at the time of pimobendan induction. The remaining 131 patients were divided into two groups, the reduced ejection fraction (rEF) (n = 93) and non-rEF (n = 38) groups, and further divided into the GDMT-reinforced and non-reinforced groups.ResultsIn patients with rEF, the rate of rehospitalization for heart failure was significantly lower in the GDMT-reinforced group than in the non-reinforced group (log-rank test, P = .04). However, the same trend was not observed in the non-rEF group.ConclusionsReinforcing GDMT may reduce the heart failure rehospitalization rate in patients with pimobendan administration and rEF. However, multicenter collaborative research is needed.Trial registrationIRB Approval by the Nippon Medical School Hospital Ethics Committee B-2021-433 (April 10, 2023).

Abstract PS05-01: Accuracy and safety of fibroblast activation protein inhibitor (FAPI) PET/CT in diagnosis of axillary lymph node metastasis in early breast cancer patients: a prospective cohort study (PFB-01&02 study)

Abstract Background Axillary lymph node (ALN) is the most common metastatic site of breast cancer (BC) and the status of ALN determines the staging, treatment and prognosis for BC patients. Traditional imaging techniques, including ultrasound (US), mammography, MRI, and 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) were still unsatisfactory to evaluate the status of ALN non-invasively. Fibroblast activation protein (FAP) is highly expressed in cancer-associated fibroblasts and FAP inhibitor (FAPI) PET has been found quite promising in BC. Well-designed prospective large cohort study concerning the diagnostic performance and safety profile of FAPI PET/CT in detection of ALN metastasis of BC is still lacking. Furthermore, FAPI could be radio-labeled with different radio-nuclides including 68Ga and 18F, and there is yet no data concerning the 18F-labeled FAPI in BC. In this study, we investigated the accuracy of FAPI (both 68Ga-FAPI-04 and Al18F-FAPI-04) PET/CT in newly diagnosed BC patients for assessing ALN metastasis. We also compared the diagnostic performance of FAPI PET/CT with that of 18F-FDG PET/CT and US. Methods This prospective study was approved by the Peking Union Medical College Hospital Ethics Committee and was registered online at NIH ClinicalTrials.gov (NCT05574907, NCT05574920). The inclusion criteria were as follows: (1) age 18-80 years old; (2) newly diagnosed BC confirmed by biopsy or with BI-RADS category 4C or 5 lesions by US. The exclusion criteria were as follows: (1) pregnancy or lactation; (2) patients unwilling to undergo PET/CT scans. All patients received biopsy or surgery on breast lesion and ALN. Patients received FAPI and 18F-FDG PET/CT after enrollment. The safety profile of FAPI PET was monitored after injection using the Common Terminology Criteria for Adverse Events. Two experienced nuclear medicine physicians, who were blinded to the pathological diagnosis and other imaging results, assessed the PET/CT images. It was defined as visually positive if the radioactive uptake of the ALN was higher than that of the adjacent normal tissue. The sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) were calculated for each diagnostic test. The McNemar test was applied to compare the differences of sensitivity and specificity between FAPI PET/CT, 18F-FDG PET/CT, and US. All statistical tests were performed two-sided, and P< 0.05 was considered statistically significant. Results In total, 113 patients (27-79 years old, median age 66) were enrolled. 53 patients underwent 68Ga-FAPI-04 PET/CT, and the other 60 patients underwent Al18F-FAPI-04 PET/CT. All patients underwent 18F-FDG PET/CT and US. A total of 53/113 (46.9%) patients were finally diagnosed with ALN metastasis. The sensitivity, specificity, accuracy, PPV, and NPV were 90.6%, 90.0%, 90.3%, 88.9%, and 91.5% for FAPI PET/CT, 84.9%, 73.3%, 78.8%, 73.8%, and 84.6% for 18F-FDG PET/CT, 83.0%, 76.7%, 79.6%, 75.9%, and 83.6% for US, respectively (Table 1). The specificity of FAPI PET/CT was significantly higher than that of 18F-FDG PET/CT (P < 0.05) and US (P < 0.05). The sensitivity of FAPI PET/CT was higher than that of 18F-FDG PET/CT (P= 0.45) and US (P= 0.29). There was no significant difference of sensitivity and specificity between 18F-FDG PET/CT and US (P > 0.05). The sensitivity, specificity, accuracy, PPV, and NPV were 92.0%, 92.9%, 92.5%, 92.0%, and 92.9% for 68Ga-FAPI-04 PET/CT, and 89.3%, 87.5%, 88.3%, 86.2%, and 90.3% for Al18F-FAPI-04 PET/CT, respectively (Table 2). The 68Ga-FAPI-04 PET/CT and Al18F-FAPI-04 PET/CT procedures were well tolerated in all patients. The only adverse event was injection pain in 12/53 (22.6%) patients injected with 68Ga-FAPI-04, and 7/69 (10.1%) patients injected with Al18F-FAPI-04, which might relate to the ethanol in the imaging agent. Conclusion The FAPI PET/CT outperformed 18F-FDG PET/CT and US in the diagnosis of ALN metastasis among early breast cancer patients. The 68Ga-FAPI-04 and Al18F-FAPI-04 PET/CT have similar diagnostic performance. The FAPI PET/CT procedures were well tolerated in all patients. Table 1 Diagnostic performance of FAPI PET/CT, 18F-FDG PET/CT, and ultrasound in the diagnosis of ALN metastasis Table 2 Diagnostic performance of 68Ga-FAPI-04 and Al18F-FAPI-04 PET/CT in diagnosis of ALN metastasis Citation Format: Bo Pan, Zhixin Hao, Chao Ren, Lifan Zhang, Yidong Zhou, Qiang Sun, Li Huo. Accuracy and safety of fibroblast activation protein inhibitor (FAPI) PET/CT in diagnosis of axillary lymph node metastasis in early breast cancer patients: a prospective cohort study (PFB-01&02 study) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PS05-01.

Protocol for cost-effectiveness analysis of a randomised trial of mHealth coaching (Bump2Baby and Me) compared with usual care for healthy gestational weight gain and postnatal outcomes in at-risk women and their offspring in the UK, Australia, Ireland and Spain

IntroductionGestational diabetes mellitus and overweight are associated with an increased likelihood of complications during birth and for the newborn baby. These complications lead to increased immediate and long-term healthcare costs...

Metformin for low back pain: Study protocol for a randomised, double-blind, placebo-controlled trial

BackgroundChronic low back pain is a major cause of pain and disability with limited effective therapies. Metformin is a safe, inexpensive, well-tolerated drug that has pleotropic effects, including effects on pain pathways that may influence low back pain. The aim of this randomised, double-blind, placebo-controlled trial is to determine whether metformin reduces low back pain over 4 months in individuals with chronic low back pain. Methods and analysisOne hundred and twenty-three participants with chronic low back pain will be recruited from the community in Melbourne, Australia, and randomly allocated in a 1:1 ratio to receive either metformin 2g or identical placebo daily for 4 months. The primary outcome will be change in pain intensity assessed using a 100 ​mm visual analogue scale at 4 months and the secondary outcomes will be change in low back disability, physical activity and narcotic use. Adverse events will be recorded. The primary analysis will be by intention to treat. DiscussionGiven the societal burden of LBP and the limited effective treatment options available, this study that evaluates the efficacy of metformin in LBP, if proves to be effective, will offer an important therapeutic approach for this disabling condition. Ethics and disseminationEthics approval has been obtained from the Alfred Hospital Ethics Committee (392/21) and Monash University Human Research Ethics Committee (30607). Written informed consent will be obtained from all the participants. The findings will be disseminated through peer-review publications and conference presentations. Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12621001453875 (registered 25th October 2021).