Consent Form Research Articles

Knowledge and perception of stroke management practices among middle-aged residents of Otolo community in Nnewi North Local Government Area, Nigeria

BackgroundStroke is a leading cause of morbidity and mortality globally, with Nigeria having one of the highest stroke mortality rates in Africa. The burden of stroke is particularly high in middle-aged individuals, who are often the primary breadwinners and caregivers in their families. Despite the high burden of stroke in this community, there is a paucity of studies on the knowledge and perception of stroke management practices among middle-aged residents of Otolo community.AimThis study investigated the knowledge and perception of middle-aged residents of Otolo community in Nnewi North Local Government Area to stroke management practices; and to identify certain sociodemographic factors that may influence the knowledge and perception of this residents.MethodA total of 191 middle-aged residents of Otolo community in Nnewi North Local Government Area, participated in this cross-sectional study. A self-reported questionnaire was distributed to the participants in the meeting venues, churches and market places with the help of research assistants after filling the consent forms. The data collection lasted for four weeks and it took the average of 12 min to complete each questionnaire. Analysis of the collected data was done using IBM Statistical Package for Social Sciences (SPSS) version 26.ResultThe findings of this study revealed that the study participants had a better knowledge of medical stroke management 36 (19%) than traditional stroke care 19(10%). Majority of the participants had a positive perception of medical stroke care129 (68%) than traditional management practices110 (58%). Age, educational status and occupational status were found to have statistically significant association (p < 0.05) with the participants’ knowledge, while the educational attainment and occupational status were the major demographic variables found to be associated (p > 0.05) with the respondents’ perception of stroke management practice.ConclusionThe middle-aged residents of Otolo community had a fair knowledge of medical management of stroke and a poor knowledge of traditional stroke care. Majority of the study respondents had a more positive perception of medical management of stroke as compared to traditional management. Some of the sociodemographic factors found to impact knowledge and perception of this management practices includes age, educational attainment and occupation.

The use of large language models to enhance cancer clinical trial educational materials.

Adequate patient awareness and understanding of cancer clinical trials is essential for trial recruitment, informed decision-making, and protocol adherence. While Large Language Models (LLMs) have shown promise for patient education, their role in enhancing patient awareness of clinical trials remains unexplored. This study explored the performance and risks of LLMs in generating trial-specific educational content for potential participants. GPT4 was prompted to generate short clinical trial summaries and multiple-choice question-answer pairs from informed consent forms (ICFs) from ClinicalTrials.gov. Zero-shot learning was used for summaries, using a direct summarization, sequential extraction, and summarization approach. One-shot learning was used for question-answer pairs development. We evaluated performance through patient surveys of summary effectiveness and crowdsourced annotation of question-answer pair accuracy, using held-out cancer trial ICFs not used in prompt development. For summaries, both prompting approaches achieved comparable results for readability and core content. Patients found summaries to be understandable, and to improve clinical trial comprehension and interest in learning more about trials. The generated multiple-choice questions achieved high accuracy and agreement with crowdsourced annotators. For both summaries and multiple-choice questions, GPT4 was most likely to include inaccurate information when prompted to provide information that was not adequately described in the ICFs. LLMs such as GPT4 show promise in generating patient-friendly educational content for clinical trials with minimal trial-specific engineering. The findings serve as a proof-of-concept for the role of LLMs in improving patient education and engagement in clinical trials, as well as the need for ongoing human oversight.

Poisoning and overdose at a glance.

Poisoning and overdose are significant public health concerns in the UK, with poisoning accounting for more than 115000 hospital presentations in England in 2021-2022. Nurses are crucial in managing patients from triage to discharge. Nurses' role in treating poisoning and overdose cases involves recognising toxidromes, initial stabilisation and symptom management. Commonly ingested substances include paracetamol, ibuprofen and illicit drugs; pharmacological interventions available include antidotes such as acetylcysteine and naloxone. Patients require a multidisciplinary approach, and collaborative care may involve clinical toxicologists, mental health professionals and social services to ensure comprehensive recovery. Ethical considerations of poisoning treatment include patient consent and the complexities of intentional overdoses. By understanding the nuances of poisoning and overdose treatment, health professionals can offer compassionate, evidence-based care.

A pilot study to explore utility of electronic informed consent in a low- income setting; the case of a Controlled human infection study in Blantyre, Malawi

Background Electronic informed consent can improve accuracy, workflow, and overall patient experience in clinical research but has not been used in Malawi, owing to uncertainty about availability, utility, patient data security and technical support. Objectives We aimed to explore the utility of electronic consent (e-consent) in an ongoing human infection study in Blantyre, Malawi. Methods The approved paper consent forms were digitized using Open Data Kit (ODK). Following participant information giving by the research staff, healthy literate adult participants with no audio-visual impairments completed a self-administered e-consent and provided an electronic signature. We dual-consented participants by both paper-based and electronic-consenting. Signed e-consent forms were uploaded to a secure study server. Utility of e-consenting was observed by participation rate, user-friendliness, documentation error rate, and staff perception of the overall consenting process. Results All 109 participants offered e-consenting accepted participation. E-consenting was user-friendly, had no identifiable documentation errors as compared to 43.1% (n 47/109) error rate with paper-based consenting, and ensured data safety, and unravelled areas for consideration. Challenges with e-consenting included difficult digitization of ethics stamped documents, as well as present but infrequent delays of retrieval of e-consent forms. Conclusion E-consenting is feasible, has a utility benefit in a controlled human infection study in Malawi; a low-income country, and can supplement paper-based consenting. Its usefulness can improve the consenting process in research conducted in such settings. Additionally, success of e-consenting requires a careful consideration.

Evaluating the role of G-rated videos in enhancing English fluency among preschoolers

G-rated video materials have become a boon for today's generation. Pre-schoolers often integrate these materials into their daily routines. This study displayed the effects of G-rated video materials on pre-schoolers’ English fluency. The respondents of this study consisted of 26 pre-schoolers from the University of Saint Louis Tuguegarao. The researchers used total enumeration to gather data, ensuring the involvement of the entire population. Participants were handed a parental consent form along with a pre-survey that solicited their background profile on G-rated video materials. Following this, the researchers conducted one-on-one recording sessions with the pre-schoolers using standardized questions. A language instructor validated the recordings using a standardized rubric to determine the preschool’s fluency. The chi-square test was used to analyze the data and assess the relationship between watching G-rated video materials and the English fluency of pre-schoolers. The findings indicated that there is no significant association between the two variables, suggesting other factors may contribute to fluency development.

Informed consent in dementia research: how Public Involvement can contribute to addressing “old” and “new” challenges

Informed consent is a critical ethical requirement in research, ensuring the protection of participants' rights and promoting their wellbeing and autonomy. In dementia research, this process becomes particularly complex due to cognitive impairments and fluctuating capacity. While substantial work has been done to address these challenges, much of the literature on informed consent in dementia research has been shaped by the perspectives of researchers and healthcare professionals, with less focus on those with lived experience. This paper provides an overview of the perspectives of people with dementia and their carers resulting from Public Involvement activities organized by Alzheimer Europe. It builds on Alzheimer Europe's previous work with the European Working Group of People with Dementia and draws on discussions held during a face-to-face meeting about Participant Informed Consent forms and processes used in two specific European projects. We highlight views and key concerns raised by people with lived experience regarding the informed consent process, including barriers and facilitators. In addition to ensuring understandability, the discussions emphasized the importance of promoting respect and autonomy, ensuring that the values and interests of people with lived experience remain central throughout the research process. This paper contributes to the ongoing dialogue on improving informed consent practices in dementia research, highlighting the need for continuous involvement and the inclusion of people with lived experience in shaping consent practices to address both old and emerging challenges (i.e., new types of research such as artificial intelligence and data sharing/re-use) in dementia research.

The impact of obtaining explicit informed consent for medical student participation in the pelvic examination underanesthesia: A qualitative interview study.

To examine patient, physician, and operating room (OR) staff perceptions at an academic institution following the introduction of an explicit, written consent form for medical student participation in the pelvic examination under anesthesia (EUA). The study was performed at one urban academic medical center between May 2021 and May 2023. Thirty-one individuals including patients, OR staff, and physicians were interviewed to better understand their perspectives regarding an initiative to explicitly consent patients for the student pelvic EUA. Northwestern University Institutional Review Board approval was obtained. Patients appreciated being asked to explicitly consent to or refuse the student pelvic EUA and having a dedicated consent form left them with a positive feeling about the hospital and their healthcare providers. OR staff and physicians agreed that the student pelvic EUA is necessary, and almost all supported an explicit consent form. Physicians did not find the additional consent form burdensome and noted only a modest decline in learning opportunities. Patients and healthcare providers agreed that requiring explicit written consent for the student pelvic EUA respected patient autonomy, improved healthcare quality, and caused minimal disruption to medical education. Our data support the use of an explicit written consent form as standard practice.

Challenges and Opportunities for Data Sharing Related to Artificial Intelligence Tools in Health Care in Low- and Middle-Income Countries: Systematic Review and Case Study From Thailand.

Health care systems in low- and middle-income countries (LMICs) can greatly benefit from artificial intelligence (AI) interventions in various use cases such as diagnostics, treatment, and public health monitoring but face significant challenges in sharing data for developing and deploying AI in health care. This study aimed to identify barriers and enablers to data sharing for AI in health care in LMICs and to test the relevance of these in a local context. First, we conducted a systematic literature search using PubMed, SCOPUS, Embase, Web of Science, and ACM using controlled vocabulary. Primary research studies, perspectives, policy landscape analyses, and commentaries performed in or involving an LMIC context were included. Studies that lacked a clear connection to health information exchange systems or were not reported in English were excluded from the review. Two reviewers independently screened titles and abstracts of the included articles and critically appraised each study. All identified barriers and enablers were classified according to 7 categories as per the predefined framework-technical, motivational, economic, political, legal and policy, ethical, social, organisational, and managerial. Second, we tested the local relevance of barriers and enablers in Thailand through stakeholder interviews with 15 academic experts, technology developers, regulators, policy makers, and health care providers. The interviewers took notes and analyzed data using framework analysis. Coding procedures were standardized to enhance the reliability of our approach. Coded data were reverified and themes were readjusted where necessary to avoid researcher bias. We identified 22 studies, the majority of which were conducted across Africa (n=12, 55%) and Asia (n=6, 27%). The most important data-sharing challenges were unreliable internet connectivity, lack of equipment, poor staff and management motivation, uneven resource distribution, and ethical concerns. Possible solutions included improving IT infrastructure, enhancing funding, introducing user-friendly software, and incentivizing health care organizations and personnel to share data for AI-related tools. In Thailand, inconsistent data systems, limited staff time, low health data literacy, complex and unclear policies, and cybersecurity issues were important data-sharing challenges. Key solutions included building a conducive digital ecosystem-having shared data input platforms for health facilities to ensure data uniformity and to develop easy-to-understand consent forms, having standardized guidelines for data sharing, and having compensation policies for data breach victims. Although AI in LMICs has the potential to overcome health inequalities, these countries face technical, political, legal, policy, and organizational barriers to sharing data, which impede effective AI development and deployment. When tested in a local context, most of these barriers were relevant. Although our findings might not be generalizable to other contexts, this study can be used by LMICs as a framework to identify barriers and strengths within their health care systems and devise localized solutions for enhanced data sharing. PROSPERO CRD42022360644; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=360644.

Using dataflow diagrams to support research informed consent data management communications: participant perspectives.

Digital health research involves collecting vast amounts of personal health data, making data management practices complex and challenging to convey during informed consent. We conducted eight semi-structured focus groups to explore whether dataflow diagrams (DFD) can complement informed consent and improve participants' understanding of data management and associated risks (N = 34 participants). Our analysis found that DFDs could supplement text-based information about data management and sharing practices, such as by helping raise new questions that prompt conversation between prospective participants and members of a research team. Participants in the study emphasized the need for clear, simple, and accessible diagrams that are participant centered. Third-party access to data and sharing of sensitive health data were identified as high-risk areas requiring thorough explanation. Participants generally agreed that the design process should be led by the research team, but it should incorporate many diverse perspectives to ensure the diagram was meaningful to potential participants who are likely unfamiliar with data management. Nearly all participants rejected the idea that artificial intelligence could identify risks during the design process, but most were comfortable with it being used as a tool to format and simplify the diagram. In short, DFDs may complement standard text-based informed consent documents, but they are not a replacement. Prospective research participants value diverse ways of learning about study risks and benefits. Our study highlights the value of incorporating information visualizations, such as DFDs, into the informed consent procedures to participate in research. Future research should explore other ways of visualizing consent information in ways that help people to overcome digital and data literacy barriers to participating in research. However, creating a DFD requires significant time and effort from research teams. To alleviate these costs, research sponsors can support the creation of shared infrastructure, communities of practice, and incentivize researchers to develop better consent procedures.

Comparison of cold and tepid modified delnido cardioplegia on myocardial protection in open heart surgery patients

Objectives: Cardioplegia is a crucial component of myocardial protection during aortic cross-clamping and cardiopulmonary bypass. It has been reported to provide effective myocardial protection and improved clinical outcomes with enhanced surgical flow in adult cardiac procedures. This study investigates the efficacy and safety of cold-modified Del Nido cardioplegia versus tepid blood cardioplegia in adult cardiac surgery patients using Myotherm, a device mainly used in cardiac surgery to monitor and manage the myocardial temperature during surgery. Methods: After obtaining approval from the ethics committee and establishing entry criteria that included age, type of heart surgery, and absence of cardioplegic contraindications, the researchers defined exclusion criteria-such as previous heart surgery or significant comorbidities. Seventy patients were randomly divided into two groups: Group A received a cold solution at 4°C( n=35), while Group B received a tepid solution at 28°C (n=35).The amount of cardioplegia was 10 to 15 cc/kg and was injected with a pressure of 70 to 90 mm Hg in an anterograde manner. The temperature of cardioplegia was also adjusted with a Myotherm device. The day before the surgery, a written consent form was obtained from the patients, and the patients were informed about the study method. The sampling method is a double-blind clinical trial to achieve minimal bias, ensuring the reliability of the results and reducing influences on it. This study was conducted in Afshar Hospital in Yazd during 2023 and 2024. Results: There were no significant differences between the two groups in terms of the need for an intra-aortic balloon pump (p=1.0), intraoperative and postoperative inotropic support (p=0.26), and postoperative pacemaker (p=0.49). Also, there were no significant differences between the two groups in terms of troponin I level after surgery (p=0.50), left ventricular ejection fraction after discharge (p=0.34), time to return of spontaneous heart rhythm (P=0.25), cross-clamp time (P=0.30), cardiopulmonary bypass time (P=0.07), and length of stay in the ICU (P=0.21). Conclusions: The result showed that both techniques provide similar results. Although the time of cross-clamp and cardiopulmonary bypass was shorter in the group using tepid solution, these differences were not statistically significant. In other words, cold and tepid solutions are equally effective and safe to protect the myocardium, and doctors can use both types of solutions during open heart surgery.

Association of HindIII Polymorphism of the Lipoprotein Lipase (LPL) Gene (rs320) and Plasma Metabolic Parameters in aNigerian Population.

Genetic variations in the lipoprotein lipase (LPL) gene including the HindIII polymorphism (rs320) have been reported to modify fat metabolism, adiposity, and body weight. However, little attention has been given to the African population. The present study aimed to investigate the relationship between the rs320 gene polymorphism and a number of metabolic and anthropometric parameters in a sample of the Nigerian population. We recruited 236 participants for the study. The participants were required to sign informed consent forms after which information related to their calorie intake and utilization as well as anthropometric measurements were recorded. Plasma metabolic parameters were subsequently determined using an autoanalyzer. Genotyping for HindIII polymorphism was performed using the PCR-RFLP method. The frequencies (n) of T and G alleles were 0.841 (397) and 0.158 (75), while the frequencies (n) of TT, TG, and GG were 0.691(163), 0.301(71), and 0.01(2), respectively. The population was not in Hardy-Weinberg equilibrium (χ2 = 3.717, df = 1, p = 0.841). The anthropometric parameters, the fasting blood glucose, and low-density lipoprotein cholesterol showed no association with the alleles, while plasma high-density lipoprotein cholesterol and total cholesterol were significantly higher among the G allele carriers. However, triglyceride and total protein were significantly higher among the non-G allele carriers. The LPL HindIII gene polymorphism is associated with changes in plasma lipid profile in a sample of the Nigerian population.

Abstract TP119: What do participants want in a consent form? A systematic review

Introduction: Informed consent is a cornerstone of modern clinical research, though ensuring consent has long been recognized as problematic. This is especially true for acute stroke trials, where the time-sensitive nature of treatment challenges traditional consent practices. The era of platform adaptive trials will likely add further complexity to acute stroke consent. Therefore, we sought to survey the literature for any empirical studies documenting research participants’ preferences around what content is most important to include in consent forms. Methods: We conducted a systematic review of the literature to identify empirical studies reporting patients’ opinions about what content is most important to include in consent forms for research participation. Eligible studies included surveys, focus groups, or interviews. Based on a review of consent form templates, we identified 18 elements that commonly appear in consent forms, and used these to guide our extraction of potential content. Results: Of the 1,444 studies screened by title and abstract, 35 were sent to full text review, and data were extracted from 17 studies. To determine the ubiquity of the importance of these topics, we counted if each of these topics appeared in the 17 papers. The most commonly mentioned items included risks (65%, 11/17 studies), potential benefits (53%, 9/17 studies), study procedures e.g. blood draws and imaging (47%, 8/17 studies), confidentiality (47%, 8/17 studies), study rationale (41%, 7/17 studies), and voluntariness (41%, 7/17 studies). The least important elements included information about the condition and investigator conflicts of interest. Conclusion: In the era of adaptive platform trials for acute stroke, there is the potential for consent forms to become incredibly lengthy and complex. This is the first systematic review of which we are aware that seeks to identify what information is most important to be included in consent forms to participate in research studies. Unfortunately, data are limited but they suggest that consent form optimization is possible. Only risks and potential benefits were identified as important in a majority of studies.

Abstract TP141: Who Obtains Informed Consent for Endovascular Thrombectomy in Acute Stroke? A Survey of Clinicians.

Introduction: Informed consent (IC) plays a central role in medical care and research. Practices for endovascular thrombectomy (EVT) in acute stroke are not well elucidated. We investigated the clinical roles and medical specialties of individuals who obtain IC for EVT, aiming to provide insights for enhancing the process in contemporary stroke care. Methods: We conducted a survey from July to December 2023 among clinicians involved in acute stroke care. Utilizing Qualtrics, we disseminated a structured questionnaire through various national and international platforms including the American Academy of Neurology and StrokeNet. This analysis summarizes findings pertaining to the characteristics of those who obtain EVT IC at the respondents’ institution. Results: Among 168 participants, 71% were staff physicians, 70% practiced in the United States (US), and 70% were based at academic centers. The most common medical specialties obtaining EVT IC were neurology (77%), followed by neurosurgery (41%), radiology (30%) and emergency medicine (10%) ( Table 1 ). Staff physician (61%) was the most common clinical role involved, followed by fellows (43%), residents (48%), and advanced practice providers (APP, 36%) ( Table 2 ). Non-US institutions were more likely to utilize a provider from neurology alone (50% vs. 31%, p=0.016) and staff physicians (76% vs. 54%, p=0.008), while US institutions were more likely to utilize providers from neurosurgery (51% vs. 18%, p&lt;0.001), APPs (43 vs. 18%, p=0.002) and residents (56% vs. 28%, p=0.001). Non-academic institutions more frequently used emergency medicine providers (25% vs. 5%, p&lt;0.001) and APPs (50% vs. 31%, p=0.031), while academic institutions commonly utilized neurosurgery providers (48% vs. 18%, p=0.001), residents (59% vs. 13%, p&lt;0.001) and fellows (52% vs. 18%, p&lt;0.001). Conclusion: This study highlights the diverse medical specialties and clinical roles of persons obtaining IC for EVT, with neurologists and staff physicians being the most frequently utilized. These variations likely reflect availability and capacity of certain providers in different settings. Future efforts to optimize the IC process should be multi-disciplinary, with standardized content that addresses issues such as ischemic core volume, outcome expectations and diversity.

Computer vision algorithms in healthcare: Recent advancements and future challenges.

Computer vision has emerged as a promising technology with numerous applications in healthcare. This systematic review provides an overview of advancements and challenges associated with computer vision in healthcare. The review highlights the application areas where computer vision has made significant strides, including medical imaging, surgical assistance, remote patient monitoring, and telehealth. Additionally, it addresses the challenges related to data quality, privacy, model interpretability, and integration with existing healthcare systems. Ethical and legal considerations, such as patient consent and algorithmic bias, are also discussed. The review concludes by identifying future directions and opportunities for research, emphasizing the potential impact of computer vision on healthcare delivery and outcomes. Overall, this systematic review underscores the importance of understanding both the advancements and challenges in computer vision to facilitate its responsible implementation in healthcare.

Patient perspectives of shared decision-making in emergency surgery.

Shared decision-making (SDM) is now considered the gold standard approach to counselling and obtaining patient consent. Research into patient perceptions of SDM is lacking and barriers to its implementation remain, specifically in the time-pressurized, high-risk emergency general surgery (EGS) setting. The aim of this work was to explore what EGS patients understand about SDM, gaining insight into their perspectives and experiences to understand the potential barriers both clinicians and patients may face. This work consisted of two parts: part 1 was an initial scoping review to inform the development of part 2-a patient and public involvement (PPI) exercise. The scoping review determined the quantity and quality of research in this area enabling long-listing of known SDM concepts. This long-list developed questions and structured discussions for the PPI exercise. Responses were transcribed, then analysed using thematic analysis. The scoping review found limited evidence for both the implementation of SDM in EGS and patients' perspectives. Seven papers considered SDM in other settings that allowed long-listing of the values and concepts for the PPI exercise. Nine patients and four supporters were identified from an established EGS database. After open discussion of the values and SDM concepts, thematic analysis was performed that identified two key themes: patient perceptions of how surgeons make decisions, and patient experiences of EGS decision-making. Five subtheme analyses showed participants were not aware of surgeons' use of '30-day mortality' and could not quantify surgical risk, feeling time pressures and out of control. Almost all relied on surgeons to make their decision, valuing the surgeon's opinion over their own. With no previous reported evidence, this work provides the first patient insights into SDM in the EGS setting. With multiple barriers identified, further work is essential to increase implementation of this gold standard approach to patient consent.

Utilization of an undergraduate emergency department research associate program for the screening and recruitment of research subjects with heart failure into a clinical study.

Enrolling heart failure (HF) patients in clinical studies is challenging. Emergency department (ED) may use students as research associates programs, such as the University of Rochester Medical Center (URMC) ED Research Associate (EDRA) program, to screen and consent patients for clinical studies. This manuscript examines the effectiveness of the URMC EDRA program in consenting HF patients into a clinical study. The URMC EDRA program recruited and consented HF patients presenting at URMC's ED. Research associates in the EDRA program identified potential patients based on age (>18 years) and chief complaints indicative of HF. After identifying potential patients, a thorough chart review was conducted, and any uncertainties were discussed with the patient and treating provider before patients were consented into the study. Descriptive statistics were used to assess the program's effectiveness. Over one fiscal year, the URMC EDRA program screened 1669 unique patients, of whom 118 (7.1%) were consented. Consented patients tended to be younger (65±12 years) than those who refused consent (70±14 years) (p=0.007). Of the 1551 patients not consented, 1021 (65.8%) were deemed ineligible. Compared to a full time research associate, the URMC EDRA program was cheaper and more productive. The URMC EDRA program was highly effective in screening and consenting HF patients, successfully consenting 118 patients (14 per month). This is a significant achievement, especially given the study's strict inclusion and exclusion criteria. Compared to other studies and a full time research associate, the URMC EDRA program demonstrated remarkable productivity.

The effect of deep diaphragmatic breathing on fatigue in patients with metastatic gastrointestinal cancers: a randomized clinical trial.

Fatigue is a common and unpleasant symptom experienced by many cancer patients. One method that has been suggested to reduce fatigue is deep diaphragmatic breathing. However, there is limited information available regarding the effectiveness of this technique for patients with advanced cancers. As a result, this study was conducted to investigate the impact of deep diaphragmatic breathing on fatigue in patients with gastrointestinal tract cancers that have spread to other parts of the body. This study, conducted in the oncology departments of Imam Reza (AS) Kermanshah Hospital in 2022, aimed to investigate the effects of an intervention test on 44 patients with malignant gastrointestinal cancer. Inclusion criteria include metastatic cancer of the gastrointestinal tract, the patient's consent to cooperate, and the age of 18-65years. Exit criteria also include transfer from the oncology department, death, misdiagnosis, and non-cooperation The patients were selected as available and randomly assigned to two groups: an experimental group and a control group. The intervention test was performed by the experimental group twice a day for 10days, with each session lasting for 10min. Before and after the intervention, both groups completed research tools, which included Piper's fatigue questionnaire and a demographic information checklist. The data collected was analyzed using SPSS version 25 software. According to the findings, before the intervention, the average total fatigue was measured at 5.15 ± 1.98 in the case group and 4.43 ± 1.74 in the control group, with no significant difference between the two groups (p = 0.213). However, after the intervention, the average total fatigue decreased to 3.59 ± 1.91 in the case group, whereas it increased to 6.14 ± 1.91 in the control group, with a significant difference between the two groups (p = 0.001). The study revealed that the method used in the treatment had a significant impact on reducing fatigue in patients. Considering its low cost and high feasibility, it is recommended to include this approach in the care plan for patients and make it a part of their routine. IRCT20220104053628N1, date: 2022-02-05.

Immigrant experiences of harm in sexual and reproductive healthcare in Spain.

The medical encounter represents a site where patients may be harmed, with intersecting vulnerabilities shaping the risk and nature of this harm. Sexual and reproductive healthcare is an important site for exploring this dynamic. Questions concerning how immigrant women experience sexual and reproductive healthcare abound, with researchers and practitioners calling for greater attention to a population whose experiences are underrepresented in existing literature. As a case site, Spain is a high migration country with a stressed healthcare system where 'good' biomedical outcomes are complicated by institutional and routinised failures in patient care. Semi-structured interviews were conducted with 121 respondents concerning health experiences since immigrating to Spain. This paper draws from 69 respondents, primarily from the Philippines, the Americas, and Europe. Overarching themes included: 1) practitioners expressing dismissive attitudes; 2) practitioners behaving inappropriately and with prejudice; 3) practitioners failing to respect patient autonomy and consent; 4) practitioners mistreating patients during procedures. These issues recurred across treatment contexts, including diagnosis, routine examinations, preventative care, pre-natal care, abortion, pregnancy loss, and childbirth. Consequences include delayed and missed care, physical and psychological harm, and implications regarding migratory, medical, and reproductive futures. Informed by feminist scholarship, this study considers the identities, relations, and practices which contour this institutionally produced harm. The study provides recommendations for improvements in medical training and clinical practice based on identified failures in the care of immigrant patients.

An exploratory phase II trial of low-dose decitabine and sintilimab combined with chemotherapy in HER2-negative gastric or gastroesophageal junction adenocarcinoma.

390 Background: Combining epigenetic modulator with PD-1 inhibitor may enhance treatment outcomes in cancer patients. This study aimed to evaluate the efficacy and safety of epigenetic drug decitabine, sintilimab (a PD-1 inhibitor), and chemotherapy in gastric cancer. Methods: In this single-arm, exploratory phase II trial, patients with HER2-negative, locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma were enrolled between August 12, 2021, and October 22, 2022. Treatment included low-dose decitabine (10 mg/m² for 5 days), sintilimab (a PD1 inhibitor, 200 mg every 21 days), and XELOX. The primary endpoint was objective response rate (ORR) and second endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. The protocol was approved by the ethics committee of the Changzhi Medical College Affiliated Changzhi People's Hospital (No. 2021K002). All patients provided written informed consent form before study participation. The trial is registered with Chinese Clinical Trial, number ChiCTR2100043312. Results: Sixteen patients were initially enrolled, with a median follow-up of 14.8 months. Eleven patients exhibited a PD-L1 combined positive score (CPS) &lt; 5. In the per-protocol sets, 11 patients remained eligible for efficacy analysis. In the intention-to-treat analysis of all 16 patients, 9 achieved partial response and 2 had stable disease, resulting in an ORR of 69% and a DCR of 56%. As of the data cutoff on November 4, 2023, the median PFS was 11.1 months (95% CI, 5.1-not reached) and the median OS was 13.2 months (95% CI, 5.1-not reached). Treatment-related adverse events were generally well-tolerated, with most being grade 1-2. Three patients experienced severe AEs, including one fatal case of grade 4 immune-related pneumonia. Conclusions: The combination of low-dose decitabine, sintilimab, and chemotherapy appears promising strategy for locally advanced or metastatic G/GEJ adenocarcinoma, especially in patients with negative HER2 and low PD-L1 expression. These preliminary findings support further investigations to confirm the benefits and explore the underlying mechanisms. Clinical trial information: ChiCTR2100043312. Objective response and disease response. Full analysis set (n=16) Efficacy analysis set (n=11) Complete response 0 0 Partial response 9 9 Stable disease 2 2 Progressive disease 0 0 Non-evaluable* 5 NA Objective response 9 (56%) 9 (81.8%) Disease control 11 (69%) 11 (100%) NA=not applicable. *Included patients without any post-baseline response assessment.

Exploring the causal paths and longitudinal impact of telework on health: the TeleHealth survey–data linkage study protocol

BackgroundThe transition from traditional office work to telework has accelerated significantly since the late 20th century, especially in light of the COVID-19 pandemic. Despite its widespread adoption, the long-term health...