Consent For Participation Research Articles

Exploring perceptions and experiences of stigma in Canada during the COVID-19 pandemic: a qualitative study

BackgroundThe COVID-19 pandemic fueled stigmatization and discrimination, particularly towards individuals of Chinese or East Asian ethnicity. We conducted interviews with members of the public in Canada in order to describe and understand stigma perceptions and experiences during the COVID-19 pandemic.MethodsWe used a phenomenological approach to describe stigma experiences of Canadian residents during the COVID-19 pandemic and compared the stigma perceptions and experiences of East Asian and non-East Asian individuals. Participants were invited to take part in a single, semi-structured interview. The interview guide was rooted in the Health Stigma and Discrimination Framework (HSDF). Interviews were conducted in English, Mandarin, and Cantonese. Following participant consent, interviews were audio recorded and transcribed verbatim. Data were double coded and analyzed using qualitative content analysis guided by a framework approach.ResultsA total of 55 interviews were conducted between May and December 2020. Fifty-five percent of the sample identified as East Asian, 67.3% identified as women, and mean age was 52 years (range 20–76). Fear of infection, fear of social and economic ramifications, and blame for COVID-19 were reported drivers of stigma. Participants described preexisting perceptions on cultural norms and media influence as facilitators of stigma that propagated harmful stereotypes, particularly against Chinese and East Asian individuals. Participants observed or experienced stigmatization towards place of residence, race/ethnicity, culture, language, occupation, and age. Stigma manifestations present in the public and media had direct negative impacts on East Asian, particularly Chinese, participants, regardless of whether or not they personally experienced discrimination.ConclusionsWe used the HSDF as a rooting framework to describe perceptions and impact of stigma, particularly as they related to race/ethnicity-based stigmatization in Canada. Participants reported a number of drivers and facilitators of stigma that impacted perceptions and experiences. These findings should be used to develop sustained strategies to mitigate stigma during public health emergencies or other major crises.

Determinants of Consent in the SHARE Accelerometer Study

The eighth wave of the Survey of Health, Aging and Retirement in Europe comprises a subsample of respondents who were asked to participate in a measurement of physical activity using thigh-worn accelerometers. This paper describes the process for obtaining consent, identifies determinants of consent, and analyzes the aggregated results of the accelerometer measurements for bias due to sample selection. The overall consent rate in the Survey of Health, Aging and Retirement in Europe accelerometer study was 54%, with variations between countries ranging from 34% to 70%. Multivariate logistic regressions show that various factors are correlated with consent such as respondents’ age, self-reported moderate activity, computer literacy, willingness to answer questions, and the interviewers’ age. After introducing inverse probability weights, there appears to be only a small and insignificant influence of participant selection and consent.

Exploring community pharmacists’ views around HRT and the menopause

Abstract Introduction The number of women in England prescribed HRT has increased dramatically in the last seven years.1 Meanwhile, from 2018, HRT product shortages have resulted in the release of Serious Shortage Protocols allowing community pharmacists to supply alternative HRT products where appropriate.2 Furthermore, in 2022, the first over-the-counter medication for vaginal atrophy in menopause was licensed.3 With so many recent changes, it seemed an opportune time to determine community pharmacists’ views on the topic. Aim The aim of this study was to explore community pharmacists’ views around HRT and the menopause. Methods A qualitative approach using semi-structured interviews was chosen to allow for exploration of views. A list of community pharmacies from Stoke-on-Trent and Staffordshire was obtained from the NHS website. They were grouped into independent and multiple pharmacies in both urban and rural areas. Twenty pharmacies were then randomly selected from across the lists, emailed and invited to participate in the study; a participant information sheet and consent form was attached. This was followed up with a telephone call one week later, and a day and time for interview was agreed. Telephone interviews were undertaken, with consent obtained verbally, and the interview digitally recorded. The interview guide was developed based on the literature review and aim of the study. The guide addressed experiences of patient queries regarding HRT and the menopause, views of the OTC vaginal tablet and their confidence in discussing menopause with patients. Interviews were transcribed verbatim and thematically analysed. Ethical approval was obtained from Keele School of Pharmacy and Bioengineering Ethics Committee. Results Nine interviews were undertaken in October 2022, lasting 10 to 15 minutes. Five interviewees were male, five from urban areas, all from different companies and experience ranged from 3 months to 45 years. Four themes emerged from the transcripts, namely: increase in queries; managing shortages; lack of knowledge on Gina®; and limited professional interest in the topic. Patients were found to rarely ask about menopausal symptoms, with most queries related to risks associated with HRT or advice on various formulations. All pharmacists found dealing with shortages to be time-consuming and potentially stressful. Many of the pharmacists had not heard of the new vaginal tablet and did not stock it. Those who did, felt it was expensive and unlikely to sell. All stated they would like further training on the menopause but only one would consider specialising as a future area of prescribing. Discussion/Conclusion This was a small study with relatively short interviews, due to the time constraints facing working pharmacists. Despite this, similarity in responses suggest that data saturation may have been reached. This study confirms previous reports of increasing queries relating to HRT, particularly around shortages, and the stress associated with dealing with them. The pharmacists stated they would like further training on the topic, although CPPE packages on menopause are available. Despite the increased attention and prescribing of HRT, there was little desire to specialise and prescribe in this area; this should be explored further.

In utero/peripartum antiretroviral therapy exposure and mental health outcomes at 8-18 years old: A longitudinal comparative study of children with perinatally acquired HIV, children perinatally HIV exposed but uninfected, and children unexposed uninfected from Uganda.

In utero/peripartum antiretroviral therapy (IPA) exposure type was examined in relationship to mental health symptoms among 577 children with perinatally acquired HIV (CPHIV), children perinatally HIV exposed but uninfected (CHEU), and children HIV unexposed uninfected (CHUU). IPA exposure was categorized for CPHIV and CHEU as none, single-dose nevirapine with or without zidovudine (sdNVP±AZT), sdNVP+AZT+lamivudine (3TC), or combination antiretroviral therapy (cART). Anxiety and depressive symptoms were reported at baseline, 6-, and 12-month follow-up per behavioral assessment system for children. Multivariable linear mixed models were used to estimate differences (b) with 95% confidence intervals (95% CI) for IPA exposure types versus CHEU without IPA exposure. Depressive and anxiety symptoms were lower in CHUU relative to CHEU and CPHIV but did not differ between CPHIV and CHEU. CHEU with sdNVP±AZT exposure had greater anxiety (b = 0.51, 95% CI: [0.06, 0.96]) and depressive symptoms (b = 0.48, 95% CI: [0.07, 0.89]) than CHEU without IPA exposure. CHEU with sdNVP+AZT+3TC exposure had higher anxiety (b = 0.0.45, 95% CI: [0.03, 0.86]) and depressive symptoms (b = 0.72, 95% CI: [0.27, 1.17]) versus CHEU without IPA exposure. Depressive and anxiety symptoms were not different for CHEU and CPHIV exposed to cART (b = 0.12-0.60, 95% CI: [-0.41, 1.30]) and CHEU and CHUU (b = -0.04 to 0.08, 95% CI: [-0.24, 0.29]) without IPA exposure. Among CHEU, peripartum sdNVP±AZT and sdNVP+AZT+3TC but not cART compared to no IPA exposure was associated with clinically important elevations in anxiety and depressive symptoms. Monitoring of mental health trajectory of HIV-affected children considering IPA is needed to inform mental health interventions. Patient Contribution: Caregivers and their dependents provided consent for participation and collaborated with study team to identify mutually convenient times for protocol implementation.

Sport Structured Brain Trauma is Child Abuse

ABSTRACT This article first summarizes research regarding the relationship between sports that intentionally structure multiple types of brain trauma into their practice, such as rugby and boxing, and the range of negative health outcomes that flow from participation in such sports. The resultant brain injuries are described as ‘now’ and ‘later’ diseases, being those that affect the child immediately and then across their lifetime. After highlighting how these sports can permanently injure children, it examines this harm in relation to existing British laws and policies concerning child abuse. The conclusion drawn is that neither children nor adults on their behalf are legally able to give informed consent for participation, and that impact sport organisations effectively groom children into sustaining and accepting brain trauma. Adults providing brain-traumatizing versions of these sports are thus described as being complicit in a form of child abuse that we term brain abuse. The contradictions in existing sports policy are highlighted, where policy describes that children are to be protected from harm, and yet the very practice of such sports creates harm by design. Implications of the argument are that children should be prohibited from partaking in impact sports.

Adolescent Athletes' Self-Presentations on Social Media and Their Self-Esteem as Moderated by Their Perceptions of Responsiveness by Others.

Social media has been an increasingly utilized communication tool, and it has gained popularity among adolescent athletes. Our aim here was to investigate whether a positive and honest self-presentation on social media increased adolescent athletes' self-esteem, and we examined the moderating effect of perceived responsiveness. After receiving informed consent of participants and their parents/legal guardians, we recruited 468 adolescent athletes/participants (244 males, 224 females; Mage = 15.39years, SD = 1.61) through purposive sampling and engaged them in completing face-to-face or online self-report measures of their: (a) self-presentation on social media, (b) perceived responsiveness of others, and (c) Rosenberg self-esteem scales. Given the continuous nature of our moderating variable (i.e., perceived responsiveness), we conducted regression analysis using Hayes's PROCESS macro in SPSS software. A positive self-presentation showed no significant relationship with self-esteem, except when the level of perceived responsiveness was high. Conversely, an honest self-presentation was positively related to higher self-esteem, and the relationship between honest self-presentation and self-esteem was moderated by perceived responsiveness. Our findings extend existing psychological theory into the online environment and have practical implications. These data highlight the link between social media self-presentation and self-esteem among adolescent athletes and illustrate the crucial role of perceived responsiveness in the social media context.

The Roles of Electronic Health Records for Clinical Trials in Low- and Middle-Income Countries: Scoping Review.

Clinical trials are a crucial element in advancing medical knowledge and developing new treatments by establishing the evidence base for safety and therapeutic efficacy. However, the success of these trials depends on various factors, including trial design, project planning, research staff training, and adequate sample size. It is also crucial to recruit participants efficiently and retain them throughout the trial to ensure timely completion. There is an increasing interest in using electronic health records (EHRs)-a widely adopted tool in clinical practice-for clinical trials. This scoping review aims to understand the use of EHR in supporting the conduct of clinical trials in low- and middle-income countries (LMICs) and to identify its strengths and limitations. A comprehensive search was performed using 5 databases: MEDLINE, Embase, Scopus, Cochrane Library, and the Cumulative Index to Nursing and Allied Health Literature. We followed the latest version of the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guideline to conduct this review. We included clinical trials that used EHR at any step, conducted a narrative synthesis of the included studies, and mapped the roles of EHRs into the life cycle of a clinical trial. A total of 30 studies met the inclusion criteria: 13 were randomized controlled trials, 3 were cluster randomized controlled trials, 12 were quasi-experimental studies, and 2 were feasibility pilot studies. Most of the studies addressed infectious diseases (15/30, 50%), with 80% (12/15) of them about HIV or AIDS and another 40% (12/30) focused on noncommunicable diseases. Our synthesis divided the roles of EHRs into 7 major categories: participant identification and recruitment (12/30, 40%), baseline information collection (6/30, 20%), intervention (8/30, 27%), fidelity assessment (2/30, 7%), primary outcome assessment (24/30, 80%), nonprimary outcome assessment (13/30, 43%), and extended follow-up (2/30, 7%). None of the studies used EHR for participant consent and randomization. Despite the enormous potential of EHRs to increase the effectiveness and efficiency of conducting clinical trials in LMICs, challenges remain. Continued exploration of the appropriate uses of EHRs by navigating their strengths and limitations to ensure fitness for use is necessary to better understand the most optimal uses of EHRs for conducting clinical trials in LMICs.

Strategies Proposed by Students and Pharmacists for Virtual Experiential Patient Care Practicums.

Background: The University of British Columbia (UBC) Pharmacists Clinic (the Clinic) is a pharmacist-led patient care clinic serving as a practice site for experiential education in a team-based primary care practice. Given the unprecedented circumstances surrounding COVID-19, some pharmacy practice sites have permanently transitioned select experiential education activities to a virtual format. Currently, there is limited literature on teaching practices that are conducive to students' success in a virtual environment. Objective: To determine the factors that enable successful development of a virtual patient care practicum experience at a university clinic from the perspectives of student pharmacists and practice educators. Methods: A qualitative research methodology was used to gain the perspectives of student pharmacists, who did not have experience with virtual practicums, and practice educators, who had some experience with virtual practicums at the time of the study. Separate focus group interviews were conducted using a semi-structured approach and consisted of questions aimed at gathering insight into participant perspectives on virtual practicums. The focus group sessions were audio recorded with participant consent and transcribed. A thematic analysis was conducted to analyze the data. Results: Three pharmacist practice educators and three student pharmacists participated in their respective focus groups. Six major themes were developed based on the data: (1) technology optimization, (2) patient care related activities, (3) student-practice educator relationship, (4) student skill development, (5) student support, and (6) in-person vs virtual practicum preferences. Proposed strategies to mitigate the limitations of virtual practicums included setting communication guidelines, arranging enriching learning opportunities, and having reliable internet connection. Conclusion: The participants in this study provided insight on factors to support successful development and delivery of a virtual patient care practicum. The results from this study can be applied to other health disciplines and their approach to virtual practicums during and following the COVID-19 pandemic.

Application of artificial neural networks in assigned leadership and academic success in medical graduates.

To apply an artificial neural networks analysis (ANN) model to identify variables that predict assigned leadership and academic success in graduates of six generations of medical school. Analytical, retrospective, comparative study. A total of 1434 graduates participated. A questionnaire was sent to them by e-mail including a voluntary participation consent. A multivariate statistical analysis using multi-layer perceptron ANN, decision trees and driver analysis was performed. The ANN identified seven independent variables that predicted professional success and eight for leadership in medical graduates. The decision trees identified significant differences in the variables professional performance (p = 0.000), age (p = 0.005) and continuing education activities (p = 0.034) related to professional success, and for leadership the variables gender (p = 0.000), high school grades (p = 0.042), performing clinical practice during the social service year (p = 0.002) and continuing education activities (p = 0.011). The ANN identified the main independent predictor variables of professional success and leadership of the graduates. This study opens up two new lines of research little studied with the techniques of in the area of medicine.

Assessment of anthropometric and physical profi le of selected school-age children in rural and urban setting in South-West Nigeria (NigeriaLINX pilot)

Objective: the objective of this study was to examine the anthropometric and physical profile of selected school-age children in rural and urban setting.Methods: the descriptive cross-sectional design was adopted for the study while multistage sampling techniques, which included simple random and systematicsampling techniques, were used to draw samples from the target population. The sample constitute healthy children who voluntarily participated in the study after consent for participation was given by individual parent. Anthropometric measurements for the study included height, weight, sitting height and BMI while the physical fitness tests for the study included sit and reach, handgrip strength, speed bounce, standing broad jump, 10m x 5 shuttles run and multistage fitness test. Z score, STEN score and independent T-Test were used for data analysis.Results: a total of 222 healthy children with average age of 10 years (male=112, female=109) participated in the study. The results showed that the urban children were taller (Urban=141.3±9.2m; Rural=134±21.3m), heavier (Urban=37.6±10.4kg; Rural=28.2±6.2kg), had more leg power (Urban=105.7±25.5; Rural=49.4±41.0) and arm strength (Urban=15.7±4.1; Rural=13.4±5.2) than rural children. However, the rural children had higher sit and reach score (Rural=25.3±5.8; Urban=22.8±6.0) and completed more laps in multistage fi tness test (Rural=35.5±25.5; Urban=12±5.7). The statistical analysis showed that all the variables were signifi cantly differenturban and rural children (P<0.05).Conclusion: the current study shows that the children in the urban and rural settings diff ered in the selected anthropometric and physical variables. Therefore, the physical education program and infrastructural facilities for physical activity and sport participation for school age children should be designed based on the socioeconomic status, social amenities and level of development of thehost community.

Glutamate receptor genetic variants affected peripheral glutamatergic transmission and treatment induced improvement of Indian ADHD probands

Attention deficit hyperactivity disorder (ADHD), a childhood-onset neurobehavioral disorder, often perturbs scholastic achievement and peer-relationship. The pivotal role of glutamate (Glu) in learning and memory indicated an influence of Glu in ADHD, leading to the exploration of Glu in different brain regions of ADHD subjects. We for the first time analyzed GluR genetic variations, Glu levels, as well as expression of Glu receptors (GluR) in the peripheral blood of eastern Indian ADHD probands to find out the relevance of Glu in ADHD prognosis. After obtaining informed written consent for participation, peripheral blood was collected for analyzing the genetic variants, Glu level, and expression of target genes. Since ADHD probands are often treated with methylphenidate or atomoxetine for providing symptomatic remediation, we have also tested post-therapeutic improvement in the ADHD trait scores in the presence of different GluR genotypes. Two variants, GRM7 rs3749380 “T” and GRIA1 rs2195450 “C”, exhibited associations with ADHD (P ≤ 0.05). A few GluR genetic variants showed significant association with higher trait severity, low IQ, lower plasma Glu level, down-regulated GluR mRNA expression, and poor response to medications. This indicates that down-regulated glutamatergic system may have an effect on ADHD etiology and treatment efficacy warranting further in-depth investigation.

Technology-Assisted Mental Health Intervention Delivered by Frontline Workers at Community Doorsteps for Reducing Anxiety and Depression in Rural Pakistan: Protocol for the mPareshan Mixed Methods Implementation Trial.

There is a dearth of specialized mental health workforce in low- and middle-income countries. Use of mobile technology by frontline community health workers (CHWs) is gaining momentum in Pakistan and needs to be explored as an alternate strategy to improve mental well-being. The aim of this study is to assess the feasibility, acceptability, and usefulness of an app-based counseling intervention delivered by government lady health workers (LHWs) to reduce anxiety and depression in rural Pakistan. Project mPareshan is a single-arm, pre- and posttest implementation research trial in Badin District, Sindh, using mixed methods of data collection executed in 3 phases (preintervention, intervention, and postintervention). In the preintervention phase, formative qualitative assessments through focus group discussions and in-depth interviews assess the acceptability and appropriateness of intervention through perceptions of all concerned stakeholders using a specific interview guide. A REDCap (Research Electronic Data Capture)-based baseline survey using Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 Scale (GAD-7) determines the point prevalence of depression and anxiety among consenting men and women older than 18 years. Individuals with mild and moderate anxiety and depression are identified as screen positives (SPs) and are eligible for mPareshan app-based intervention. Mental health literacy of health workers is improved through customized training adapting the World Health Organization's Mental Health Gap Action Programme guide 2.0. The intervention (mPareshan app) consists of tracking, counseling, and referral segments. The tracking segment facilitates participant consent and enrollment while the referral segment is used by LHWs to transfer severe cases to the next level of specialist care. Through the counseling segment, identified SPs are engaged during LHWs' routine home visits in 6 face-to-face 20-minute counseling sessions over 6 months. Each session imparts psychoeducation through audiovisual aids, breathing exercises, and coping skills to reduce stress. Clinical and implementation outcomes include change in mean anxiety and depression scores and identification of facilitators and barriers in intervention uptake and rollout. At the time of this submission (April 2024), we are analyzing the results of 366 individuals who participated in the baseline prevalence survey, the change in knowledge and skills of 72 health workers who took the mPareshan training, change in anxiety and depression scores of 98 SPs recruited for app-based counseling intervention, and perceptions of stakeholders pre- and postintervention gathered through 8 focus group discussions and 18 in-depth interviews. This trial will assess the feasibility of early home-based mental health screening, counseling, and prompt referrals by frontline health workers to reduce anxiety and depression in the community. The study findings will set the stage for integrating mental health into primary health care. Australian New Zealand Clinical Trial Registry ACTRN12622000989741; https://tinyurl.com/5n844c8z. DERR1-10.2196/54272.

Using Online Photovoice to Explore Food Decisions of Families on Low Income: Lessons Learnt During the COVID-19 Pandemic.

The method of photovoice has been previously used to effectively engage with socioeconomically disadvantaged groups and explore their eating behaviours. In this methodological article, we draw on our experiences from using photovoice through online interviews with families on low income about their food decisions. A purposive recruitment approach targeted parents of children 2-17years old who lived on a tight budget across the island of Ireland. Participants provided demographic information and were invited to take photographs of food-related decisions and activities for 1 week during the COVID-19 lockdown. The photographs were then discussed through an online communication platform to generate qualitative data. A total of 28 parents participated in the photo-elicited interviews and shared a total of 642 photographs of factors that influenced their food decisions. Following the interviews, the researchers documented their reflections which focused on (1) participants' engagement with the online photo-elicitation and (2) practical aspects around participant consent and data safety. The participants in our study engaged well with the online photovoice method and shared a variety of photos which provided ample material to facilitate the conversations around their food environment and its impact on their food decisions. Our experiences can provide novel insights into using photovoice in a virtual environment and useful considerations around ethics and data collection for researchers who work with socioeconomically disadvantaged groups. Photo-elicited interviews offer an engaging and flexible data collection technique that can highlight issues informing future priorities of healthcare policy.

Measurable Residual Disease Assessment in Patients with Acute Myeloid Leukemia Aged ≥60 Years Treated with a 10-Day Decitabine Schedule Versus Intensive Chemotherapy in the AML21 Study (NCT02172872)

Introduction Several studies have demonstrated that patients with acute myeloid leukemia (AML) who test measurable residual disease (MRD) positive during or after treatment have a higher probability of relapse and a shorter duration of survival, as compared to those who are persistently MRD negative. Indeed, a status of MRD positivity reflects a condition of resistant disease, existing below the threshold of the morphologic evaluation of complete remission (CR). The bulk of our knowledge in terms of MRD assessment has been generated in the setting of intensive chemotherapy; much less is known for older patients receiving less intensive treatments, such as decitabine (DEC) using a 10-day schedule. Methods The AML21 study was a randomized open-label phase 3 clinical trial conducted by the EORTC Leukemia Group, GIMEMA, and GMDS-SG. Patients with a newly diagnosed AML, aged ≥60 years and eligible for intensive chemotherapy were randomized 1:1 to receive DEC (20mg/m2 a day) using a 10-day schedule or intensive chemotherapy regimen consisting of daunorubicin 60 mg/m2 x 3 days and cytarabine 200 mg/m2 x 7 days (3+7), followed by 1-4 additional chemotherapy cycles. Patients who had an HLA-matched donor and at least stable disease were encouraged to undergo HSCT after >1 treatment cycle. Patients from the DEC arm not receiving HSCT could continue DEC treatment. A subset of patients treated in GIMEMA sites underwent a prospectively planned MRD evaluation post cycle 3 (DEC arm)/post consolidation (3+7 arm), and at 6, 12 and 18 months after the randomization, in case they were in a first CR and had not been allografted. MRD was studied by multiparameter flow cytometry. Based on several retrospective validations in the context of former EORTC/GIMEMA protocols, the threshold for discriminating MRD negative from MRD positive cases was set at 3.5x10-4 (0.035%) residual leukemic cells, upon full blood count recovery. Results In total, 130 out of 154 patients treated in GIMEMA centers provided consent for participation in translational research, had leukemia associated immunophenotype suitable for MRD monitoring, and initiated the protocol treatment, DEC (N=66) or 3+7 (N=64). Median age was 68 years (range 60-78), 33% of patients were ≥70 years old, 54% were male, and 31% and 30% had good and adverse European LeukemiaNet 2017 risk profile, respectively. At the MRD evaluation post cycle 3/consolidation, 9 out of 66 (14%) patients from the DEC and 12 out of 64 (19%) patients from the 3+7 arm had documented MRD negativity. The number of patients who either had documented MRD negativity or had undergone allografting and were alive and progression-free was 12 (18%) and 17 (27%) at 6 months, 14 (21%) and 13 (20%) at 12 months, and 14 (21%) and 7 (11%) at 18 months in the DEC and 3+7 arms, respectively. The inspection of individual profiles of patients who underwent the first MRD evaluation (and were at remission at that time) indicated that all MRD-positive patients from the DEC arm who were not allografted eventually relapsed, which often occurred just after the discontinuation of DEC maintenance. Conclusions 10-day DEC treatment can induce MRD-negativity. However, early MRD-negativity appeared more difficult to achieve with 10-day DEC than with 3+7. Among patients in whom 10-day DEC did not induce MRD-negativity, allografting or DEC maintenance appeared necessary to avoid a disease relapse.

Cohort profile: the U-BIRTH study on peripartum depression and child development in Sweden

PurposeThe current U-BIRTH cohort (Uppsala Birth Cohort) extends our previous cohort Biology, Affect, Stress, Imaging and Cognition (BASIC), assessing the development of children up to 11 years after birth. The...

A survey of informed consent in patients with dementia in the US and Japan.

This study aimed to confirm the reality of family-focused medical treatment of dementia in Japan and the US. It conducted a questionnaire survey on informed consent from patients with dementia among neurologists and psychiatrists in four prefectures in the Tokai Region (Aichi, Gifu, Mie, and Shizuoka) and dementia specialists in the US. Of the responses, 120 (39.7% response rate) and 20 (5.9% response rate) were obtained, respectively. In obtaining informed consent from patients with dementia, 75 Japanese specialists (62.5%) and 16 US specialists (80.0%) regularly assessed patients' decision-making abilities. The majority of specialists in both Japan and the US used the Mini-Mental State Examination and Hierarchic Dementia Scale-Revised, which are widely used for cognitive function assessment. In the survey, 27 Japanese specialists (22.5%) and 10 US specialists (50.0%) had different considerations when obtaining informed consent for participation in research, compared to their medical practice. The majority of Japanese and US specialists obtained informed consent from both the patient and their family.

Informed consent and participant protection in human biodatabases: present and future

<p>近年來，由於精準醫療發展的需求，帶動生物醫學研究蓬勃發展，以人口群或疾病罹患者群體為基礎的人體生物資料庫（biobank）因為同時蒐集生物檢體、基因資訊與醫療資料，可大量節省研究者於研究過程招募受試者的時間成本，而可方便於串連不同來源的生物或醫療資訊，因而越來受到重視。就生物資料庫的參與者自主權保障而言，取得參與者的知情同意（informed consent），與其他人體研究略有不同。其不同之處在於，生物資料庫所取得的是參與者概括式同意(broad consent)因此，應告知事項更著重於生物資料庫本身運作機制、未來風險的告知、基因資訊對自己與家屬的影響等，也因此參與者同意書法定說明項目較其他人體研究更多，以我國的人體生物資料庫管理條例第7條規定應說明事項即有17項，超過人體研究法定應告知事項9項。其次，就參與者而言，參與生物資料庫面對的生理風險較小，但其他的風險又過於抽象遙遠，容易因此輕忽。整體而言，如何取得參與者有效的同意，完整的知情、充分的理解，應由參與者角度，檢視同意書提供的資訊是否適於理解，說明與取得同意過程，如何發展適合評估方式以參與者確認理解。現行知情同意的過程多較為單向，同意書的說明、資訊的告知較少由參與者角度思考參與生物資料庫的意義。當生物資料庫連結越來越多項目的醫療、非醫療個人資料資訊後，參與者參與將更為重要，亦即，如何確認參與者的真正理解。畢竟，知情同意作為保護參與者自主權，其要件之一即是充分理解，有必要與時俱進引入不同的作法。</p> <p> </p><p>In recent years, due to the demand for the development of precision medicine, biomedical research has been booming. Human biological databases (biobanks) based on population groups or disease patient groups can simultaneously collect biological specimens, genetic information and medical data. It saves researchers the time and cost of recruiting subjects during the research process, and can facilitate the connection of biological or medical information from different sources, so it has attracted more and more attention. In terms of ensuring the autonomy of participants in biological databases, obtaining informed consent from participants is slightly different from other human studies. The difference is that the biodatabase obtains broad consent from the participants. Therefore, the matters that should be notified focus more on the operation mechanism of the biodatabase itself, notification of future risks, and the impact of genetic information on yourself and your family members. etc. Therefore, there are more statutory explanation items in the participant consent form than in other human studies. According to Article 7 of China’s Human Biological Database Management Regulations, there are 17 items that should be explained, exceeding the 9 items that are legally required to be notified in human research. Secondly, as far as the participants are concerned, the physiological risks faced by participating in the biological database are relatively small, but other risks are too abstract and distant, so it is easy to ignore them. Overall, how to obtain effective consent, complete knowledge, and full understanding from participants should be done from the perspective of the participant, including whether the information provided in the consent form is suitable for understanding, explaining and obtaining the consent process, and how to develop appropriate evaluation methods for participation. The person confirms understanding. The current informed consent process is mostly one-way, and the explanation of the consent form and the notification of information rarely reflect the meaning of participating in the biodatabase from the perspective of the participant. As biodatabases link more and more items of medical and non-medical personal information, participant participation will become even more important, that is, how to confirm participants’ true understanding. After all, one of the requirements for informed consent, as a means of protecting participant autonomy, is a full understanding of the need to keep pace with the times and introduce different practices.</p> <p> </p>

Long-term outcomes with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in ST-segment elevation myocardial infarction: 5-year follow-up of the BIOSTEMI randomised superiority trial

Biodegradable polymer sirolimus-eluting stents improve early stent-related clinical outcomes compared to durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. The long-term advantages of biodegradable polymer sirolimus-eluting stents after complete degradation of its polymer coating in patients with STEMI remains however uncertain. BIOSTEMI Extended Survival (BIOSTEMI ES) was an investigator-initiated, follow-up extension study of the BIOSTEMI prospective, multicentre, single-blind, randomised superiority trial that compared biodegradable polymer sirolimus-eluting stents with durable polymer everolimus-eluting stents in patients with STEMI undergoing primary percutaneous coronary intervention at ten hospitals in Switzerland. All individuals who had provided written informed consent for participation in the BIOSTEMI trial were eligible for this follow-up study. The primary endpoint was target lesion failure, defined as a composite of cardiac death, target vessel myocardial re-infarction, or clinically indicated target lesion revascularisation, at 5 years. Superiority of biodegradable polymer sirolimus-eluting stents over durable polymer everolimus-eluting stents was declared if the Bayesian posterior probability for a rate ratio (RR) of less than 1 was greater than 0·975. Analyses were performed according to the intention-to-treat principle. The study was registered with ClinicalTrials.gov, NCT05484310. Between April 26, 2016, and March 9, 2018, 1300 patients with STEMI (1622 lesions) were randomly allocated in a 1:1 ratio to treatment with biodegradable polymer sirolimus-eluting stents (649 patients, 816 lesions) or durable polymer everolimus-eluting stents (651 patients, 806 lesions). At 5 years, the primary composite endpoint of target lesion failure occurred in 50 (8%) patients treated with biodegradable polymer sirolimus-eluting stents and in 72 (11%) patients treated with durable polymer everolimus-eluting stents (difference of -3%; RR 0·70, 95% Bayesian credible interval 0·51-0·95; Bayesian posterior probability for superiority 0·988). In patients undergoing primary percutaneous coronary intervention for STEMI, biodegradable polymer sirolimus-eluting stents were superior to durable polymer everolimus-eluting stents with respect to target lesion failure at 5 years of follow-up. The difference was driven by a numerically lower risk for ischaemia-driven target lesion revascularisation. Biotronik.

Associations between Serum CRP Concentration, Maternal Hypertension, and Fetal Outcome: A Comparative Analysis in Pregnant Women

Introduction: Pre-eclampsia is a complex disorder characterized by hypertension and proteinuria after 20 weeks of gestation, posing risks to maternal and fetal health. It is linked to adverse outcomes worldwide, with varying incidence rates across regions. Risk factors include history, maternal age, and socioeconomics. The pathophysiology involves issues with spiral artery adaptation. The study aimed to analyze the associations between serum CRP concentration, maternal hypertension, and fetal outcomes in pregnant women. Methods: This cross- sectional analytical study was conducted at the Department of Obstetrics and Gynecology at the Institute of Child and Mother Health (ICMH), Matuail, Dhaka. It took place from January to December 2018. The study population comprised 120 pregnant women within the gestational age of 28-40 weeks. The women were categorized into three groups: Group A (control) consisted of normotensive pregnant women, Group B included pregnant women with mild pre-eclampsia, and Group C comprised pregnant women with severe pre-eclampsia. Ethical guidelines were followed, including IRB approval and participant consent. Data were analyzed using SPSS software, version, 22.0. Chi-Square, t-test, and ANOVA test were performed to determine associations among the study variables of the groups, where p<0.05 considered as the level of significance. Results: The study enrolled 120 participants divided into Groups A, B, and C. The majority fell within the 18-25 age range. The mean ages were 24.23±4.52 (Group A), 24.73±4.01 (Group B), and 24.26±3.07 (Group C). BMI was significantly higher in Groups A and B compared to Group C (p < 0.05). Gestational age was lower in mild and severe preeclampsia compared to normal pregnancies (p < 0.05). Cesarean section delivery was significantly more frequent in preeclamptic mothers (p < 0.001). CRP levels varied, with means of 3.07 (Group A), 9.67 (Group B), and 13.15 (Group C), showing significant differences (p < 0.05). Fetal birth weight was lowest in Group C (2.61) and highest in Group A (2.95). Severe preeclampsia patients had elevated CRP levels, with 93.3% exhibiting this trend (p < 0.05). Adverse neonatal outcomes were more common in preeclampsia cases, including prematurity, LBW, and neonatal complications (p < 0.05). Increased CRP levels were associated with low birth weight (p < 0.001) and lower APGAR scores (p < 0.01). Conclusion: Pre- eclampsia shows raised serum CRP levels, particularly pronounced in severe cases, with about 83% of patients affected. This heightened CRP connects to adverse fetal outcomes.

Understanding Medical Students’ Concerns about Explicit Informed Consent for Pelvic Exams Under Anesthesia

Medical student involvement in procedures, including pelvic exams under anesthesia (EUAs), is a fundamental part of medical education. While guidelines exist regarding informed consent for medical student participation, there is ongoing debate and uncertainty regarding the requirement and modality of obtaining explicit consent for pelvic EUAs. This study aims to explore the perceptions and experiences of medical students who do not favor an explicit informed consent process for pelvic EUAs. An anonymous online questionnaire was distributed to third- and fourth-year medical students at the University of Pittsburgh School of Medicine who had completed their obstetrics and gynecology core clerkship. The questionnaire included both quantitative and qualitative sections. Qualitative analysis was conducted using a mixed inductive and deductive coding approach, with key patterns, categories, and themes identified through content analysis. Among the 201 students included in the analysis, 50 students did not endorse an explicit informed consent process for pelvic EUAs. Themes that emerged from their open-ended responses included: (1) the belief that medical student involvement is implicitly included in patient agreements at teaching hospitals; (2) the perception that pelvic EUAs are an essential first step in gynecologic surgery; (3) the view that pelvic EUAs are comparable to other medical procedures; (4) concern that explicit consent would limit educational opportunities; and (5) the belief that pelvic EUAs are not harmful or traumatic to patients. The findings highlight the justifications provided by medical students who do not support explicit informed consent for pelvic EUAs. While some arguments align with previous ethical analyses, this study provides empirical and qualitative insights into students' perspectives. The belief that patients implicitly consent to medical student involvement at teaching hospitals warrants further examination, as patient awareness and understanding may vary. The differentiation between pelvic exams and other EUAs, as well as the perception of minimal harm, should be critically evaluated in the context of trauma-informed care and patient autonomy. Furthermore, the interconnectedness of educational and surgical aspects of pelvic EUAs should be clarified in patient-physician communication. Understanding the perspectives of medical students who do not favor explicit consent for pelvic EUAs is crucial for developing and implementing consent processes. The findings emphasize the need for enhanced patient-physician communication, standardized frameworks for learner involvement, and curricular adaptations to address patient perceptions and trauma-informed care. Future research should explore these themes in larger and more diverse cohorts to inform best practices in obtaining informed consent for medical student participation in pelvic EUAs.