Consent For Participation Research Articles

Relationship Between Health Literacy Level and the Adoption of Preventive Behaviors Against Coronavirus Disease

Background: Health literacy skills play a pivotal role in adopting preventive behaviors. The COVID-19 pandemic has brought renewed emphasis on health-oriented behaviors, and health literacy is considered one of the most influential indicators affecting health-centric behaviors. Objectives: This study was conducted to determine the relationship between the level of health literacy and the adoption of preventive behaviors against COVID-19 among students at Jundishapur University of Medical Sciences in Ahvaz. Methods: In this study, the research population comprised 223 newly enrolled students from seven main faculties at Jundishapur University of Medical Sciences in Ahvaz in the year 2022. Participants were randomly selected, and data collection instruments included a COVID-19 prevention questionnaire and a health literacy questionnaire for adults. The questionnaire links and study participation consent forms were sent to the participants. Inclusion criteria consisted of willingness and consent to participate in the study, and enrollment in the first year of study (either the first or second semester) in various academic levels at Ahvaz University of Medical Sciences. The exit criteria were defined as failure to respond to more than 5% of the questions. After data collection, descriptive statistics, correlation coefficient tests, and regression analysis were employed using SPSS software for data analysis. Results: The findings revealed that women, married individuals, employed participants, and those with underlying health conditions obtained higher scores in preventive behaviors against COVID-19 and health literacy. Regression coefficients indicated that a one-unit increase in health literacy scores could lead to a 0.439-unit increase in preventive behaviors against COVID-19. According to correlation analysis, a positive, direct, and significant correlation existed among all dimensions of health literacy and preventive behaviors against COVID-19 (P < 0.05), with the behavioral dimension being the only significant predictor of preventive behaviors. Specifically, a one-unit increase in the behavioral dimension score could result in a 0.373-unit increase in preventive behaviors against COVID-19 (P < 0.001). Conclusions: The results showed that health literacy is directly related to COVID-19 preventive behaviors. Therefore, to promote preventive behaviors against infectious diseases, special attention should be paid to health literacy and its influential dimensions. Recognizing the importance of advancing health literacy across various dimensions can significantly contribute to the control and prevention of communicable diseases.

Social capital development in online education and its impact on academic performance and satisfaction

PurposeThe first objective is to investigate and determine the social capital development of students in online education. The second objective is to analyze the influence of social capital on students’ academic success and educational satisfaction. The third objective is to generate recommendations to foster social capital development.Design/methodology/approachA quantitative research approach is employed, with 264 respondents comprising students from colleges and universities in Malaysia. The data gathering instrument is an online questionnaire administered with the informed consent of participants. Data analysis is performed using structural equation modeling (SEM).FindingsThe results show that the faculty capital and peer capital components of social capital have not been compromised in online education, but the family capital component has declined. As such, it is concluded that there is a general decline in overall social capital in online education. These findings form the basis for recommendations on promoting social capital development among students in colleges and universities internationally.Research limitations/implicationsThis study focused on study periods during the COVID-19 pandemic where online learning and communication were strictly enforced, providing a unique opportunity to explore how students adapted their social capital development. However, this is not meant to be a representation of scenarios where students are given the option of either physical or online education or a combination of both.Practical implicationsAcademic and institutional management implications are evident, and recommendations are made based on the findings.Social implicationsThe findings and subsequent recommendations have considerable social implications in terms of social sustainability of education practices and policies.Originality/valueThe COVID-19 pandemic that started in March 2020 and subsequent prolonged periods of physical lockdowns in many countries have forced colleges and universities that customarily practice classroom education to shift to online education temporarily. This situation created a novel “natural experiment” when classes or programs from the same college or university that are customarily conducted in classrooms (in person) were conducted online during the pandemic, thus contributing to the originality of the findings.

Coerced consent in clinical research: study protocol for a randomized controlled trial

BackgroundDespite the low-risk nature of participation in most clinical anesthesia trials, subject recruitment on the same day as surgery is often restricted due to the concerns of researchers and local research ethics boards that same-day consent may not afford adequate time and opportunity for patients to weigh and make decisions, as well as perceptions of patient vulnerability immediately prior to surgery that could impact the voluntary nature and the rigor of the informed consent process. However, specialties such as anesthesiology, critical care, interventional radiology, and emergency medicine have a varied pattern of practice and patient acquaintance that does not typically afford the luxury of time or, in many cases, advance consent for participation in research. Indeed, the initial encounter between anesthesiologists and patients undergoing elective procedures routinely occurs on the day of surgery. Concerns of coercion related to same-day consent for clinical anesthesia research trials have not been borne out in the literature, and represent a significant obstacle to clinical researchers, as well as to the patients who are denied opportunities for potential benefit through participation in research studies.MethodsWe describe the protocol for a prospective randomized controlled trial examining the voluntariness of patient consent, solicited either in advance of surgery or on the same day, to participate in an anesthesia research study at Women’s College Hospital. One hundred fourteen patients scheduled to undergo ambulatory anterior cruciate ligament repair facilitated by general anesthesia with an adductor canal block will be randomized for recruitment either (a) in the pre-operative assessment clinic before the day of surgery or (b) on the day of surgery, to be approached for consent to participate in a fabricated research study of adjunct medications in adductor canal blocks. Regardless of allocation, patients in both groups will receive the same routine standard of care and will complete a post-operative questionnaire to signal perceptions of undue influence in the process of providing informed consent for the fabricated trial.DiscussionThis study will inform trial design and practice guidelines surrounding the amount of time patients ought to be afforded in order to make durable decisions to participate (or not) in clinical research studies. This is expected to impact trial recruitment in a variety of clinical settings where researchers have only brief opportunities to interface with patients.Trial registrationThe trial was registered prospectively on the Open Science Framework (OSF), registration #46twc, on 2023-Mar-17.

Protocol for a telephonic mixed methods study to understand needs and find solutions for bereaved dementia caregivers

IntroductionMost caregivers of people living with dementia will experience bereavement within 10 years, but study of and support for their needs rarely persists following the death of their care recipients....

Prevalence and associated risk factors of hypertension among pregnant women in rural areas of Dibrugarh District, Assam.

Hypertension is one of the most common medical disorders complicating pregnancies and complicates 5 to 10% of all pregnancies. To estimate the prevalence of hypertension among pregnant women and to determine the associated obstetric risk factors of hypertension among them in rural areas of Dibrugarh district, Assam. Community-based cross-sectional study. The present study was conducted on pregnant women of villages under two health blocks at that point of time from May 2017 to April 2018. The sample size was calculated to be 384. The estimated number of pregnant women in each block was noted, and the pregnant women to be included from each block and from each sub-centre was determined by proportional allocation. Data were collected by house-to-house survey in the villages of the respective sub-centre. A pre-designed and pre-tested proforma was used to collect the data. Data were analysed using Chi-square test, Fisher's exact test, and logistic regression. A total of 384 pregnant women gave consent for participation. The prevalence of hypertension in pregnancy was 9.1%. Among the obstetric factors, multigravidity, multiparity, period of gestation >20 weeks, history of hypertension in previous pregnancy, and history of prior still birth were statistically significant risk factors of hypertension in pregnancy. Logistic regression analysis showed period of gestation >20 weeks to be independent predictor of hypertension in pregnancy. The awareness of obstetric risk factors for hypertension in pregnancy may give ways for prevention in this population.

Recurrent disease detection after resection of pancreatic ductal adenocarcinoma using a recurrence-focused surveillance strategy (RADAR-PANC): protocol of an international randomized controlled trial according to the Trials within Cohorts design

BackgroundDisease recurrence remains one of the biggest concerns in patients after resection of pancreatic ductal adenocarcinoma (PDAC). Despite (neo)adjuvant systemic therapy, most patients experience local and/or distant PDAC recurrence within 2 years. High-level evidence regarding the benefits of recurrence-focused surveillance after PDAC resection is missing, and the impact of early detection and treatment of recurrence on survival and quality of life is unknown. In most European countries, recurrence-focused follow-up after surgery for PDAC is currently lacking. Consequently, guidelines regarding postoperative surveillance are based on expert opinion and other low-level evidence. The recent emergence of more potent local and systemic treatment options for PDAC recurrence has increased interest in early diagnosis. To determine whether early detection and treatment of recurrence can lead to improved survival and quality of life, we designed an international randomized trial.MethodsThis randomized controlled trial is nested within an existing prospective cohort in pancreatic cancer centers in the Netherlands (Dutch Pancreatic Cancer Project; PACAP) and the United Kingdom (UK) (Pancreas Cancer: Observations of Practice and survival; PACOPS) according to the “Trials within Cohorts” (TwiCs) design. All PACAP/PACOPS participants with a macroscopically radical resection (R0-R1) of histologically confirmed PDAC, who provided informed consent for TwiCs and participation in quality of life questionnaires, are included. Participants randomized to the intervention arm are offered recurrence-focused surveillance, existing of clinical evaluation, serum cancer antigen (CA) 19–9 testing, and contrast-enhanced computed tomography (CT) of chest and abdomen every three months during the first 2 years after surgery. Participants in the control arm of the study will undergo non-standardized clinical follow-up, generally consisting of clinical follow-up with imaging and serum tumor marker testing only in case of onset of symptoms, according to local practice in the participating hospital. The primary endpoint is overall survival. Secondary endpoints include quality of life, patterns of recurrence, compliance to and costs of recurrence-focused follow-up, and the impact on recurrence-focused treatment.DiscussionThe RADAR-PANC trial will be the first randomized controlled trial to generate high level evidence for the current clinical equipoise regarding the value of recurrence-focused postoperative surveillance with serial tumor marker testing and routine imaging in patients after PDAC resection. The Trials within Cohort design allows us to study the acceptability of recurrence-focused surveillance among cohort participants and increases the generalizability of findings to the general population. While it is strongly encouraged to offer all trial participants treatment at time of recurrence diagnosis, type and timing of treatment will be determined through shared decision-making. This might reduce the potential survival benefits of recurrence-focused surveillance, although insights into the impact on patients’ quality of life will be obtained.Trial registrationClinicaltrials.gov, NCT04875325. Registered on May 6, 2021.

Views of children and young adults about Whole Genome Sequencing in newborn screening: a qualitative study

Whole Genome Sequencing (WGS) in newborn screening is ethically complex. Parents will provide proxy consent for initial participation and 16-year-olds will be approached to consent to continued storage of their genome. We explored the views of 11–25-year-olds to understand the information needs of this age group and the views of the next generation of parents. This two-phase UK study involved: a secondary analysis of focus groups with young adults and a diary and focus group study with children with CF. Diaries were analysed using content analysis, focus group data were analysed using reflexive thematic analysis. Diaries illustrated how children formed genomic knowledge and their questions. Participants broadly supported WGS-NBS based on a belief that all results improve health. Pre-study knowledge was sometimes correct, other-times it drew on vicarious ideas that could cause distress. Children showed an ability to appreciate the complexity of deciding which results should be returned. Focus groups: All participants counterbalanced the benefits and risks of WGS-NBS. Children demonstrated innate trust in doctors, whereas young adults wanted parent-doctor collaboration in decision-making. Young adults conditionally supported WGS-NBS depending on treatability, severity, onset and consent. Children wanted parents to be informed of a broader range of results, but valued informed choice too. More research is needed to understand healthy children’s views. Although small samples, this work provides insight into the understanding and concerns of young adults and children which could help when trying to discuss this topic with them.

The AlzMatch Pilot Study - Feasibility of Remote Blood Collection of Plasma Biomarkers for Preclinical Alzheimer’s Disease Trials

BackgroundAdvances in plasma biomarkers to detect Alzheimer’s disease (AD) biology allows researchers to improve the efficiency of participant recruitment into preclinical trials. Recently, protein levels of plasma amyloid-beta and tau proteins have been shown to be predictive of elevated amyloid in brain. Online registries, such as the Alzheimer’s Prevention Trials (APT) Webstudy, include and follow participants using remote assessments to facilitate efficient screening and enrollment of large numbers of individuals who may be at higher risk for AD.ObjectivesThe AlzMatch Pilot Study investigated the feasibility of recruiting individuals from an online registry for blood sample collection at community-based phlebotomy centers and plasma biomarker quantification to assess an individual’s eligibility for AD preclinical trials.DesignPilot feasibility study with co-primary outcomes.SettingThis pilot feasibility study included participants from the APT Webstudy, the remote assessment arm of the Trial-ready cohort for Preclinical and Prodromal AD (TRC-PAD) Platform. Novel design included collection of electronic consent, use of community laboratories for plasma collection, mass spectrometry-based biomarker assay, and telephone communication of plasma biomarker screening eligibility.ParticipantsParticipants invited to the AlzMatch pilot feasibility study were active in the APT Webstudy, 50 years of age or older, resided within 50 miles of both a Quest Diagnostics Patient Services Center (a national diagnostic laboratory with convenient locations for sample collection and processing) and one of six TRC-PAD vanguard clinical trial sites, had no self-reported dementia diagnosis, were able to communicate in English and engaged with the APT Webstudy within the prior 6 months.MeasurementsPrimary feasibility outcomes were completion of electronic consent (e-consent) for invited participants and collection of usable blood samples. Additional feasibility outcomes included invitation response rate, plasma biomarker eligibility status (based on amyloid beta-42/40 [Aβ42/40] concentration ratio), ApoE proteotype, and trial inclusion criterion), and completion of telephone contact to learn eligibility to screen for a study.Results300 APT Webstudy participants were invited to consent to the AlzMatch study. The AlzMatch e-consent rate was 39% (n=117) (95% CI of 33.5%–44.5%) overall, which was higher than the expected rate of 25%. Similar consent rates were observed across participants based on self-defined sex (41% Female (n=75), 37% Male (n=42)) and race and ethnicity (37% from underrepresented groups (URG) (n=36), 40% not from URG (n=79)). Among those that consented (n=117), plasma was successfully collected from 74% (n=87) (95% CI of 66%–82%), with similar rates across sex (76% Female (n=57), 71% Male (n=30)) and race and ethnicity (75% URG (n=27) and 75% not from URG (n=59)). 60% (n=51) of participants with plasma biomarker results were eligible to screen for future preclinical AD trials.ConclusionElectronic consent of participants through an online registry, blood sample collection at community-based centers, plasma biomarker quantification and reporting, and biomarker assessments for study eligibility were all feasible with similar engagement rates across demographic groups. Although this pilot was a small and selective sample, participants engaged and consented at higher than expected rates. We conclude that collecting blood at community laboratories for biomarker analyses may improve accessibility beyond research, and may facilitate broader access for clinical use of AD plasma biomarkers. Based on our results, an expanded version of the AlzMatch study is underway, which involves expanding invitations to additional APT Webstudy participants and clinical trial sites.

Study Protocol for the Artificial Intelligence-Driven Evaluation of Structural Heart Diseases Using Wearable Electrocardiogram (ID-SHD).

Portable devices capable of electrocardiogram (ECG) acquisition have the potential to enhance structural heart disease (SHD) management by enabling early detection through artificial intelligence-ECG (AI-ECG) algorithms. However, the performance of these AI algorithms for identifying SHD in a real-world screening setting is unknown. To address this gap, we aim to evaluate the validity of our wearable-adapted AI algorithm, which has been previously developed and validated for detecting SHD from single-lead portable ECGs in patients undergoing routine echocardiograms in the Yale New Haven Hospital (YNHH). This is the protocol for a cross-sectional study in the echocardiographic laboratories of YNHH. The study will enroll 585 patients referred for outpatient transthoracic echocardiogram (TTE) as part of their routine clinical care. Patients expressing interest in participating in the study will undergo a screening interview, followed by enrollment upon meeting eligibility criteria and providing informed consent. During their routine visit, patients will undergo a 1-lead ECG with two devices - one with an Apple Watch and the second with another portable 1-lead ECG device. With participant consent, these 1-lead ECG data will be linked to participant demographic and clinical data recorded in the YNHH electronic health records (EHR). The study will assess the performance of the AI-ECG algorithm in identifying SHD, including left ventricular systolic dysfunction (LVSD), valvular disease and severe left ventricular hypertrophy (LVH), by comparing the algorithm's results with data obtained from TTE, which is the established gold standard for diagnosing SHD. All patient EHR data required for assessing eligibility and conducting the AI-ECG will be accessed through secure servers approved for protected health information. Data will be maintained on secure, encrypted servers for a minimum of five years after the publication of our findings in a peer-reviewed journal, and any unanticipated adverse events or risks will be reported by the principal investigator to the Yale Institutional Review Board, which has reviewed and approved this protocol (Protocol Number: 2000035532).

A Study on Autonomic Dysfunction in Type 2 Diabetes Mellitus with Peripheral Neuropathy

Abstract Introduction: Subclinical Autonomic Neuropathy is found in association with distal symmetric polyneuropathy in diabetic patients. The Aim of this study was to compare the Cardiac Autonomic Function Test parameters in Type 2 Diabetes Mellitus patients with and without Distal Peripheral Neuropathy. The Primary Objective was to compare the mean of Valsalva ratio in Type 2 Diabetes Mellitus patients with and without Distal Peripheral Neuropathy. The secondary Objective of this study was to find the correlation between Michigan Neuropathic Screening Instrument Score and Autonomic Function test parameters in type 2 Diabetes Mellitus patients. Methods: This was a single centre, cross sectional study conducted from July 2022 to Feb 2023. The study was commenced after obtaining Institute Ethics Committee clearance. Subjects who satisfied the inclusion and exclusion criteria, and gave informed consent for participation in this study were eligible for enrolment. The inclusion Criteria were patients aged between 18 and 65 years with diagnosis of Diabetes mellitus. The number required to study Diabetic patients with peripheral neuropathy was 34 and for Diabetic patients without peripheral neuropathy was 34. Total sample size of 68 patients was taken. Once the patient was enrolled a detailed history, clinical examination, ANS testing and MSNI scoring was done as per attached pre verified proforma duly vetted by institutional scientific committee.Patients were asked to refrain from vigorous exercise for the 24 hours before to the cardiovascular testing as well as from eating, drinking, or smoking for at least 2 hours before the autonomic testing. At the conclusion of the checkup, all antidiabetic and other prescriptions were given. After data collection, test for normality of data was done. Appropriate statistical tests were applied according to data distribution and analysed by using SPSS criteria 2011. Results: A total of 68 patients, 34 with symptoms of Diabetic Peripheral Neuropathy and 34 without Diabetic Peripheral Neuropathy were studied from July 2022 to December 2023. The age, BMI, duration of disease, HbA1c, resting systolic blood pressure and heart rate didn’t show any significant difference between the two groups and thus the groups were comparable. The median (interquartile range) of MNSI score of diabetic patients without neuropathy was 1(1,1) and diabetic patients with neuropathy was 8 (7,9) with p value < 0.005. There was a significant difference in E: I ratio (P<0.0001) between diabetic patients with and without neuropathy. The mean ± SD of Valsalva ratio, in diabetic patients without neuropathy was 1.632 ± 0.115 and with neuropathy was 1.366 ± 0.045. There was a significant difference in Valsalva ratio (P<0.0001). There was a good negative correlation between MNSI score and Valsalva ratio with r= -0.769 and p value < 0.0001 in Type 2 Diabetes mellitus patients. Conclusion: This study found that the Cardiac Autonomic Function Test parameters in Type 2 Diabetes Mellitus patients with and without Distal Peripheral Neuropathy, were significantly deranged in patients with symptomatic DPN. The mean of Valsalva ratio was significantly different in two study groups. The correlation between Michigan Neuropathy Screening Instrument Score and Autonomic Function test parameters in Type 2 Diabetes Mellitus patients showed strong negative correlation. The patients with symptomatic DSN were found to have higher MSNI scores, who in turn were having severe cardiac autonomic dysfunction. Recommendation of Study: Mean Valsalva ratio and MNSI testing are recommended to be used as a screening tool to assess cardiac autonomic functions as a low cost tool in patients of T2DM having symptoms suggestive of DSN.

Speech production and perception data collection in R: A tutorial for web-based methods using speechcollectr.

This tutorial is designed for speech scientists familiar with the R programming language who wish to construct experiment interfaces in R. We begin by discussing some of the benefits of building experiment interfaces in R-including R's existing tools for speech data analysis, platform independence, suitability for web-based testing, and the fact that R is open source. We explain basic concepts of reactive programming in R, and we apply these principles by detailing the development of two sample experiments. The first of these experiments comprises a speech production task in which participants are asked to read words with different emotions. The second sample experiment involves a speech perception task, in which participants listen to recorded speech and identify the emotion the talker expressed with forced-choice questions and confidence ratings. Throughout this tutorial, we introduce the new R package speechcollectr, which provides functions uniquely suited to web-based speech data collection. The package streamlines the code required for speech experiments by providing functions for common tasks like documenting participant consent, collecting participant demographic information, recording audio, checking the adequacy of a participant's microphone or headphones, and presenting audio stimuli. Finally, we describe some of the difficulties of remote speech data collection, along with the solutions we have incorporated into speechcollectr to meet these challenges.

The Prevalence of Internet Use as a Source of Information Among Patients With Hypertension.

Background and objective The incidence of hypertension is growing at an alarming rate globally. In the United States, nearly half of the adult population suffers from hypertension, a diseasepotentially associated with long-term dire consequences and comorbidities. While Internet access has proliferated, and free Internet-based education resources for healthy lifestyles have exponentially increased over the past two decades, little is known about whether Internet-based information can be or is used as a self-learning tool for hypertension management in a community setting. With almost no published data, if and to what degree Internet-based, self-directed learning tools are used for hypertension management needs to be assessed. In light of this, we aimed to evaluate the prevalence of Internet use as asource of information in patients with known diagnoses of hypertension who presented to our Internal Medicine clinic at Texas Tech University Health Sciences Center, El Paso. Materials and methods We conducted a single-center, cohort-based observational study at our teaching hospital's internal medicine clinic. A survey questionnaire was distributed to all adults aged more than 18 yearswith a known diagnosis of hypertension. Consent for participation was obtained from all participants. Of the total studied population, 93.6% (190/203) were of Hispanic descent. Moreover, 67.5% (137/203) identified as female. Of note, 22.7% (46/203) reported using the Internet to learn about hypertension. Internet users were younger, with a mean age of 61.4 years compared to 68.7 (p=0.02) years for non-Internet users, attended institutions of a higher grade of education, and mostly received information regarding hypertension from their families (91.3% vs 2.5%, p<0.001). While most patients used the Internet for making treatment decisions and were satisfied with their choices, more than a quarter felt confused and anxious after using Internet-based resources. Results Most patients in the study were found to not use the Internet as a resource tool for hypertension management (157/203; 77.3%). Among the 22.7% of patients who used the Internet for hypertension management, the most commonly utilized resource was Google.com, as an initial step to hypertension research (26/46, 58.6%, p<0.001), followed bymultiple resources within a predetermined list on the provided survey (14/46, 30.4%). The survey also assessed the reasons for using Internet-based resources, with the primary reason being evaluating treatment options (19/46, 41.5%), followed by developing coping skills (13/46, 28.2%), and lastly aiding in decision-making (10/46, 21.5%). Conclusions Internet-based educational tools are mushrooming as the Internet is becoming more pervasive. This study shows that within this predominant Hispanic population, nearly one-quarter of patients with hypertension are using Internet-based, self-learning tools. This highlights a slow shift in medical education which providers have to be prepared for as patients will be using these tools as secondary information sources for medical decision-making more frequently going forward. Further studies need to be conducted to evaluate the current and longitudinal impact of these new information sources.

Influence of patient awareness and health disparities on early identification of neutropenic sepsis risk.

e13711 Background: Neutropenic sepsis (NS) is a life-threatening condition predominantly affecting immunosuppressed cancer patients undergoing cytotoxic chemotherapy. Recognition of the associated symptoms and swift action in response is critical. Timely administration of antibiotics within the first hour of symptom onset is the gold standard of care, with each hour of delay associated with an 8% rise in mortality. Health disparities further compound this challenge by affecting patient access to healthcare. This study aimed to understand the intricacies of NS awareness amongst patients receiving chemotherapy and their caretakers, and to identify demographic and socioeconomic factors shaping this understanding. Methods: Inclusion criteria included current/prior chemotherapy patient/caregiver, any cancer type, age &gt; 18. Structured interviews were conducted by 52 North (n=15) to obtain qualitative information around NS understanding. In collaboration with the Macmillan Cancer Support, a focused online survey utilizing a 5-point Likert scale was used with 252 respondents in the United Kingdom to date. Participant consent was obtained. Results: Findings from the interviews underscored the relationship between non-adherence to NS guidelines and factors including income, socioeconomic status, and other features impacting behavior. Survey participants included: male:female – 29:219, ages 20-80+ (63.2% 51-70), patient:caregiver – 218:34. Only 160/248 (64.5%) of individuals agreed or strongly agreed that they understood NS while 65/248 (26.2%) disagreed or strongly disagreed and 23/248 (9.2%) were neutral. NS symptoms such as fever were reported by 213/252 (84.5%) of respondents, however only 87/213 (40.8%) sought medical advice in less than 1 hour, 71/213 (33.3%) waited over 1 hour, and 28/213 (13.1%) did not seek advice. Individuals reporting greater NS understanding were more than twice as likely to seek help in less than 1 hour (47.9% vs 19.6%; 68/142 vs 10/51). Individuals with salaries &gt;£40K vs &lt;£40K (~$50K) were more likely to seek help less than 1 hour after symptoms (42.5% vs 36%; 34/80 vs 33/91). Conclusions: This study reveals a compelling association between comprehension of NS and likelihood to seek treatment within the recommended 1-hour timeframe. Furthermore, higher income emerges as a factor influencing the promptness of seeking treatment. These insights highlight the critical issue of delayed care due to a lack of understanding, exacerbated by socioeconomic disparities. This study emphasizes the urgent need for enhanced education targeting at-risk groups. By addressing knowledge gaps and socioeconomic barriers, there exists a tangible opportunity to mitigate NS-related mortality in patients undergoing chemotherapy. Subsequent studies will extend these data to include the United States, to compare analysis of barriers to care in different geographic locations.

Cohort profile of BIGPROMISE: a perioperative biobank of a high-risk surgical population

PurposePostoperative complications increase mortality, disability and costs. Advanced understanding of the risk factors for postoperative complications is needed to improve surgical outcomes. This paper discusses the rationale and profile of...

A longitudinal, palliative care educational pilot in hematology-oncology fellowship training.

9007 Background: Despite national guidelines advocating that patients (pts) with advanced cancer receive dedicated palliative care (PC) services, many pts lack access to specialty PC, due to PC workforce shortage. Training hematology-oncologists (HOs) to provide primary PC could close this gap and ensure basic PC needs of pts are met. While HO fellowships require demonstration of competence in PC skills, studies have shown major deficits in PC knowledge, educational experiences and confidence. We designed a longitudinal, integrated, PC continuity rotation for HO fellows. We report feasibility, acceptability, perceived value, and impact on knowledge and practice of this novel educational model. Methods: Over 6 months, HO fellows identified patients with PC needs from their HO continuity practice and referred them to PC clinic. Fellows then saw those pts in PC clinic with the PC attending and in HO clinic with the HO attending, as well as during hospitalizations. Pt visits and HO fellow participation were tracked for feasibility. Fellows were surveyed before and after the rotation on skill confidence and knowledge, which were compared using generalized linear models for unmatched data. After the rotation, they were surveyed on acceptability and teaching quality; they also participated in a semi-structured interview assessing educational value. Fellows electronically gave informed consent for participation; the project was approved by the institutional IRB. Results: From 2018-2023, 19 fellows from 3 HO fellowship classes participated. All 19 referred 2-4 of their continuity oncology pts to the PC team and then followed these pts in both clinics longitudinally over 6 months. A total of 51 pts (#fellows-#pts: 9-2 pts; 7-3 pts; 3-4 pts) had a total of 132 PC visits. Fellows participated in 125/132 PC visits (95%); the majority were outpatient (94/132; 71%). From pre to post intervention, there was an improvement in fellows’ PC knowledge (mean 6.44/10 to 7.92, p&lt;0.01) and overall feeling of preparedness to provide PC (mean 6.33/10 to 7.75, p&lt;0.01). Ratings of skill confidence improved in 14 of 26 items (p&lt;0.05), including titration of opioids, managing pain in pts with substance use disorder, recognizing when to consider methadone, and working with an interdisciplinary team. Of 17 fellows rating acceptability, 16 (94%) rated the rotation as valuable or extremely valuable, 15 (88%) agreed or strongly agreed the rotation structure was effective, and 17 (100%) agreed or strongly agreed the rotation both changed their clinical practice and helped them feel more engaged in working with their sickest pts. Conclusions: Our pilot study of a novel, longitudinal, integrated, PC continuity rotation for HO fellows was highly feasible and acceptable. The rotation changed clinical practice and improved fellows’ PC knowledge and skill confidence. This could serve as a model for integrating PC education into HO fellowships nationally.

Characterization of remote symptom alerts generated from patient-reported outcome (PRO) symptom monitoring in a real-world breast cancer population.

e23193 Background: Women with breast cancer experience debilitating symptoms, yet the patient-reported symptom burden among patients on treatment remains largely uncharacterized. This study characterized electronic PRO (ePRO) symptom monitoring data of patients with breast cancer in real-world settings to assess differences in remote symptom alerts by clinical characteristics. Methods: We conducted a retrospective descriptive study of complete case ePRO data reported by patients at twelve US sites using Carevive PROmPT, a remote symptom monitoring platform. Participants consent to share de-identified, aggregate ePRO symptom data and sociodemographic and clinical characteristics from the electronic health record. We characterized PRO-CTCAE symptom data reported by breast cancer patients on active cancer treatment enrolled between 9/2020 and 11/2023. The PRO platform generates an algorithm-based alert if the combination of symptom severity, frequency, and interference is moderate or severe. We used descriptive statistics to characterize symptom severity and number of alerts by baseline patient-report ECOG status, age, cancer stage (Stage I-III vs. IV), and breast cancer subtype. Results: Of 646 patients, 519 (80%) generated alerts during treatment. Population characteristics were: median age 56 years-old (range 26-84), 72% White, 20% Black/African American, 62% Stage I-III, 15% HER2 positive, 47% ER and/or PR positive, HER2 negative,18% triple negative. Patients reported a total of 19,425 symptoms over a median of 12 weeks with 80% compliance rate, of which 39% resulted in alerts. Participants generated a median of 1 alert per week. About 50% of alerts occurred in the first 12 weeks of ePRO completion, with a higher proportion in Week 1-4 across all subgroups (range, 15-38%). On average, ECOG 2 or greater patients generated more alerts per week than ECOG 0-1, (mean 2.1, (SD 1.3) vs. 1.7 (SD 1.0). Younger patients ( &lt; 50 years) generated more alerts compared to those older than 50 years (87% vs. 77%). Patients with early-stage disease reported more alerts than the Stage IV group (81% vs. 78%). In the metastatic setting, triple negative patients reported a median of 3 (range 1-8) moderate/severe symptoms per week; the other subtypes reported a median of 1 (range 1-8). Conclusions: Women on breast cancer treatment reported their symptom experience with high compliance rates in the real-world setting. Nearly 40% of symptom reports generated an alert, with a higher proportion in the first month of treatment. Younger, early-stage, and metastatic triple negative patients with breast cancer reported a higher symptom burden compared to other groups. Future work will investigate symptom experience by sociodemographic and clinical characteristics to further identify patients who may benefit from more intensive symptom reporting and management.

Patient information leaflets for placebo-controlled surgical trials: a review of current practice and recommendations for developers.

Informed consent for participation in an RCT is an important ethical and legal requirement. In placebo surgical trials, further issues are raised, and to date, this has not been explored. Patient information leaflets (PILs) are a core component of the informed consent process. This study aimed to investigate the key content of PILs for recently completed placebo-controlled trials of invasive procedures, including surgery, to highlight areas of good practice, identify gaps in information provision for trials of this type and provide recommendations for practice. PILs were sought from trials included in a recent systematic review of placebo-controlled trials of invasive procedures, including surgery. Trial characteristics and data on surgical and placebo interventions under evaluation were extracted. Directed content analysis was applied, informed by published regulatory and good practice guidance on PIL content and existing research on placebo-controlled surgical trials. Results were analysed using descriptive statistics and presented as a narrative summary. Of the 62 eligible RCTs, authors of 59 trials were contactable and 14 PILs were received for analysis. At least 50% of all PILs included content on general trial design. Explanations of how the placebo differs or is similar to the surgical intervention (i.e. fidelity) were reported in 6 (43%) of the included PILs. Over half (57%) of the PILs included information on the potential therapeutic benefits of the surgical intervention. One (7%) included information on potential indirect therapeutic benefits from invasive components of the placebo. Five (36%) presented the known risks of the placebo intervention, whilst 8 (57%) presented information on the known risks of the surgical intervention. A range of terms was used across the PILs to describe the placebo component, including 'control', 'mock' and 'sham'. Developers of PILs for placebo-controlled surgical trials should carefully consider the use of language (e.g. sham, mock), be explicit about how the placebo differs (or is similar) to the surgical intervention and provide balanced presentations of potential benefits and risks of the surgical intervention separately from the placebo. Further research is required to determine optimal approaches to design and deliver this information for these trials.

Social media for palliative and end-of-life care research: a systematic review

BackgroundSocial media with real-time content and a wide-reaching user network opens up more possibilities for palliative and end-of-life care (PEoLC) researchers who have begun to embrace it as a complementary...

Driving quality in delirium care through a patient-centered monitoring system in palliative care: Protocol for the two-staged exploratory sequential mixed methods MODEL-PC study

Introduction Delirium is a serious acute neurocognitive condition that is common in palliative care units and yet under-addressed. To improve delirium care in this setting, we will develop and pilot a monitoring system that integrates the Delirium Clinical Care Standard, Palliative Care Outcomes Collaboration (PCOC) methods, and perspectives of patients, carers and staff. Methods This paper reports the protocol for a two-stage, exploratory, sequential mixed-methods implementation study. Stage 1 data collection includes Delirium Standard-aligned process mapping and clinical audits, and Critical Incident Technique interviews with patients, carers and staff with a recent experience of delirium. We will present integrated stage 1 findings to stakeholders then collaboratively develop a delirium monitoring system that aligns with the Delirium Standard and PCOC methods. In stage 2, we will pilot the new system and repeat stage 1 data collection and analyses, adding PCOC and adverse event measures. Implementation principles and strategies such as audit and feedback and education will be applied. We developed simplified participants information sheets and consent forms for interview and process mapping participants, who will provide written informed consent; and waiver of consent to collect clinical audit, PCOC and adverse event data from patients’ medical records is approved. At study end, we will report implementation, effectiveness and safety outcomes, including systemic utility of the delirium monitoring system for wider testing and use to meet the Delirium Standard in palliative care units. Quantitative data analyses will include descriptive and inferential statistics and qualitative analyses will incorporate thematic content analysis aligned to the Critical Incident Technique. Mixed methods data integration will be at the end of each stage. Discussion This protocol paper describes the mixed methods, systems integration, and innovative measures and study processes of the MODEL-PC study. We also share data collection tools and a simplified information sheet and consent form for patients.

Multicultural values: meeting point of two forces in developing Islamic education

Purpose The purpose of this study is to investigate the integration of entrepreneurial spirit and multicultural values in Islamic education, particularly within the context of pesantren, and to understand its implications for educational practices and outcomes. Design/methodology/approach This study adopts a qualitative research approach, using literature review and analysis of empirical data to explore the intersection of entrepreneurial spirit and multicultural values in Islamic education. It incorporates findings from multiple sources, including scholarly articles, books and empirical studies, to provide a comprehensive understanding of the topic. Findings The findings reveal that the integration of entrepreneurial spirit and multicultural values in Islamic education empowers students economically, fosters innovation in teaching methods and promotes character development and business ethics. Moreover, it emphasizes appreciation for diversity, cross-cultural collaboration and social responsibility within the educational context. This integration creates an inclusive learning environment conducive to the development of entrepreneurial skills, innovation and ethical leadership. Research limitations/implications Generalizability: the findings of this study may be limited in their generalizability due to the focus on specific multicultural Islamic educational institutions, potentially limiting the applicability of the results to broader educational contexts. Sample size and diversity: the study’s sample size and diversity may impact the representativeness of the findings. Future research could aim for larger and more diverse samples to enhance the robustness of the results. Methodological constraints: the reliance on certain research methods, such as surveys and interviews, may introduce biases or limitations in data collection. Researchers should consider using a variety of methodologies to triangulate findings and ensure comprehensive understanding. Time constraints: the study’s timeframe may have constrained the depth of analysis and limited the exploration of the long-term effects of entrepreneurship education on student development. Future research could adopt longitudinal approaches to address this limitation. Cultural context: the findings are contextualized within the cultural and educational landscape of multicultural Islamic institutions, which may limit their transferability to other cultural or religious contexts. Researchers should consider examining similar phenomena in diverse cultural settings. Resource constraints: resource limitations may have impacted the scope and depth of the research. Future studies could seek additional resources to conduct more extensive investigations and analyses. Bias and subjectivity: despite efforts to minimize bias, researchers’ subjectivity and potential biases in data interpretation and analysis cannot be entirely eliminated. Researchers should acknowledge and address their own biases transparently. Ethical considerations: the study may have encountered ethical challenges related to participant consent, confidentiality and cultural sensitivity. Future research should prioritize ethical guidelines and considerations to ensure the protection and well-being of participants. Addressing these limitations in future research endeavors can contribute to a more comprehensive understanding of the role and impact of entrepreneurship education in multicultural Islamic educational settings. Practical implications Practically, the study informs educational institutions, especially pesantren, about the benefits of integrating entrepreneurial spirit and multicultural values into their curriculum and pedagogical approaches. It offers insights into effective strategies for fostering entrepreneurship, innovation and intercultural competence among students. Social implications The integration of entrepreneurial spirit and multicultural values in Islamic education has broader societal implications. It cultivates a generation of socially responsible and inclusive leaders capable of addressing global challenges with creativity and empathy. By promoting cultural understanding and collaboration, it contributes to building more harmonious and resilient communities. Originality/value This study is original in its comprehensive exploration of the intersection between entrepreneurial spirit and multicultural values in Islamic education, particularly within the context of pesantren. It offers fresh insights into how these dimensions can be integrated synergistically to enhance educational practices and outcomes.