Online Consent Research Articles

A study of implementation factors for a novel approach to clinical trials: constructs for consideration in the coordination of direct-to-patient online-based medical research

BackgroundTraditional medical research infrastructures relying on the Centers of Excellence (CoE) model (an infrastructure or shared facility providing high standards of research excellence and resources to advance scientific knowledge) are often limited by geographic reach regarding patient accessibility, presenting challenges for study recruitment and accrual. Thus, the development of novel, patient-centered (PC) strategies (e.g., the use of online technologies) to support recruitment and streamline study procedures are necessary. This research focused on an implementation evaluation of a design innovation with implementation outcomes as communicated by study staff and patients for CoE and PC approaches for a randomized controlled trial (RCT) for patients with vasculitis.MethodsIn-depth qualitative interviews were conducted with 32 individuals (17 study team members, 15 patients). Transcripts were coded using the Consolidated Framework for Implementation Research (CFIR).ResultsThe following CFIR elements emerged: characteristics of the intervention, inner setting, characteristics of individuals, and process. From the staff perspective, the communication of the PC approach was a major challenge, but should have been used as an opportunity to identify one “point person” in charge of all communicative elements among the study team. Study staff from both arms were highly supportive of the PC approach and saw its promise, particularly regarding online consent procedures. Patients reported high self-efficacy in reference to the PC approach and utilization of online technologies. Local physicians were integral for making patients feel comfortable about participation in research studies.ConclusionsThe complexity of replicating the interpersonal nature of the CoE model in the virtual setting is substantial, meaning the PC approach should be viewed as a hybrid strategy that integrates online and face-to-face practices.Trial registrations1) Name: The Assessment of Prednisone In Remission Trial – Centers of Excellence Approach (TAPIR).Trial registration number: ClinicalTrials.gov NCT01940094.Date of registration: September 10, 2013.2) Name: The Assessment of Prednisone In Remission Trial – Patient Centric Approach (TAPIR).Trial registration number: Clinical Trials.gov NCT01933724.Date of registration: September 2, 2013.

Estimating the Heritability of Hoarding Symptoms: Insights from a Classical Twin Study “New Insights on the Nature of Clutter”

Objective: Hoarding disorder is a complex condition that significantly impacts individuals' lives, characterized by excessive acquiring, difficulty discarding, clutter, distress, and impairment. This study aimed to examine the extent to which genetics and environment influence difficulty discarding, excessive acquisition, and clutter through the implementation of a classical twin study. Method: This classical twin study, conducted between April and September 2021, enrolled 194 twins (97 pairs) from Isfahan, recruited through the Isfahan Twins Registry (ITR). A total of 194 twins, consisting of 100 monozygotic (MZ) and 94 dizygotic (DZ) twins, participated in this study. Participants aged 16–50 were invited electronically and completed an online consent form and questionnaire. Hoarding symptoms were assessed using the saving inventory-revised. Zygosity was determined using a self-report method based on Song et al.'s questionnaire. To estimate the heritability of hoarding symptoms, the classical univariate twin model was employed. Results: Based on the univariate analysis, the heritability estimates for difficulty discarding and excessive acquisition were found to be 0.43 and 0.52, respectively. However, the results did not provide support for the role of genetics in clutter. Instead, it was indicated that the common environment accounted for 0.54 of the variance in clutter, while the specific environment contributed 0.46 to this symptom. Conclusion: The difficulty discarding and excessive acquisition were found to be moderately heritable. On the other hand, considering the contribution of genetics and environment to clutter, the results raise doubts about the association of clutter with hoarding. The relatively low genetic influence suggests that this trait may overlap with other behaviors rather than hoarding.

Generation Scotland: an update on Scotland’s longitudinal family health study

PurposeGeneration Scotland (GS) is a large family-based cohort study established as a longitudinal resource for research into the genetic, lifestyle and environmental determinants of physical and mental health. It comprises...

Abstract PO4-17-07: RELATE 2: A real-world observational study assessing feasibility, acceptability, perceived impacts of digital apps for patients receiving olaparib or trastuzumab deruxtecan (T-DXd) as part of routine clinical practice

Abstract Background: Safe and effective use of two new treatments, T-DXd or olaparib, in breast cancer (BC) requires awareness, education and co-ownership by patients and care teams. It is hypothesized that a patient-centered digital app that provides disease and treatment-specific guidance and symptom reporting functionality while collecting specific data could positively impact patients’ confidence, self-monitoring of symptoms and experience of care. This study will develop and assess two new treatment-specific versions of the accredited OWise app to evaluate how BC patients accept and use the app and how use in routine care appears to impact patients and their experience of care in relation to monitoring symptoms. As a novel element, this study will explore the feasibility of combining treatment-specific real-world data collection with digital health support to understand how treatment patterns and characteristics in the real-world setting. OWise is a specific BC app that has been endorsed by NHS digital and is widely available through NHS app library in UK and in Netherlands. It currently has over 18K registered users. Trial Design: The study involves two workstreams which include several sources for data collection. Workstream 1 involves collection of participants OWise data (including patient entered data as well as usage statistics) and a brief survey for participants to provide feedback on their experience using OWise every three months for up to 18 months. Survey questions are focused on their perceptions of the usefulness of the app for monitoring their health changes and communicating with their care team. Workstream 2, will launch approximately three months after the launch of Workstream 1 and will include qualitative interviews with two groups of people: 1) a small number of participants who are already enrolled in Workstream 1 and 2) clinicians (and multidisciplinary team/nurses) to further understand the perceived benefits of the app. The study’s duration will be 21 months Eligibility Criteria: The patients must be prescribed either T-DXd or Olaparib and be at least 18 years of age, be able to create an OWise account (e.g., mobile or web application) and have activated the unique study code for the treatment specific version of OWise and be able to provide online consent for study participation Aims: Primary objectives are to evaluate the feasibility, acceptability, and perceived impacts on patient experience, treatment use, and quality of care of two treatment specific OWise apps in routine BC care. Secondary objectives will focus on prescribing patterns, concomitant medicine use in UK practice, understanding strategies used in the real-world setting to manage AE and demographic and clinical characteristics of patients treated in the UK Statistical methods: Aggregated Participant-level quantitative data and usage data will be analyzed for response frequencies, means, standard deviations (SD), medians, ranges, and confidence intervals (CI). Descriptive statistics and advanced statistics will be used to identify core variables and trends, investigate data distribution links between data, test significant differences between datasets according to profile/status. Target Accrual: 300 patients T-DXd and 150 olaparib using the OWise app and being part of the real-world study. The prescription decision is independent of the study enrolment. Contact: Dr Sophie McGrath. sophie.mcgrath@rmh.nhs.uk Citation Format: Sophie McGrath, Peter Hall, Michael Acquadro, Soren Skovlund, Parveen Jayia, Stuart McIntosh, David Cameron. RELATE 2: A real-world observational study assessing feasibility, acceptability, perceived impacts of digital apps for patients receiving olaparib or trastuzumab deruxtecan (T-DXd) as part of routine clinical practice [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-17-07.

Intake of energy and macronutrients in the diets of 11–13-year-old schoolchildren living in Delhi India

National surveys in India, through measures of anthropometry and biomarkers, have identified a triple burden of malnutrition (undernutrition, micronutrient deficiencies and overnutrition) in adolescents(1). However, there is a dearth of high-quality data on individual dietary behaviour of this population(2) and the importance of sub-national dietary surveys in filling this gap has been identified(3). The objective of this study was to assess the intake of energy (E) and macronutrients and the contribution of macronutrients to E in a random sample of 11–13-year-old schoolchildren in Delhi, India. Method: The study was approved by The University of Adelaide Human Research Ethics Committee and the Independent Ethics Committee of the Centre for Chronic Disease Control, New Delhi. The target sample size of 360 was based on a ± 5% margin of error in estimated sugars intakes. Using the list of private schools in Delhi (n = 1374), a statistician external to the research team generated a random sample of 150 schools stratified by districts (n = 11). Using this list, schools were invited to participate, and recruitment continued until 10 schools consented. Teachers shared study information with parents; interested parents filled in the online consent form. Assent was obtained from schoolchildren. Participants recorded all food and drink consumed over three consecutive days, including one weekend day, in a food diary. Information recorded was entered into an online dietary assessment tool, Intake24 Southeast Asia version, during an interview with each participant. The Intake24 database of over 2400 food photographs of more than 100 foods was used to ascertain portion size. The Intake24 database converts food and drink reported into the intake of nutrients through integrated food compositional tables. Of 514 pupils providing consent, 393 participants (76.4%) (169 girls, 224 boys) completed the study. The median daily E intake was 10.8 (IQR 9.0 −12.5) MJ for girls, and 12.3 (IQR 10.3- 15.2) MJ for boys. For the 97 girls and 144 boys providing body weight data, Physical Activity Level ratios were 2.0 and 2.1 respectively. The median daily intakes for girls were: protein 64.6 (IQR 54.8-79.3) g; carbohydrate 336.5 (IQR 285.3- 393.6) g; and saturated fat 45.6 (IQR 34.8-58.3) g. The respective values in boys were: protein 74.4 (IQR 61.4; 89.4) g; carbohydrate 379.6 (IQR 317.8; 461.8) g; and saturated fat 54.6 (IQR 41.9-69.5) g. There were no significant between-gender differences in percent E from protein (10.2 (IQR 9.2; 11.4)), or carbohydrate (52.4 (IQR 48.7; 56.7)). Girls obtained less E from saturated fat (16.1 (IQR 11.0-18.2) compared with boys 16.3 (IQR 14.2 - 19.1) (P<0.05). In conclusion, in this sample of adolescents from private schools in Delhi, E intake was above FAO recommended levels and median total fat intake exceeded the recommended threshold of 35%(4).

Intake of free sugars by 11–13-year-old schoolchildren living in Delhi, India

Intake of free sugars is associated with a risk of non-communicable diseases including dental caries, and authoritative organisations recommend limiting intake to <5% energy intake (E) or lower (1, 2). National surveys of schoolchildren in India indicate the prevalence of obesity is rising >10%/year(3) and that 52.5% of young adolescents are affected with dental caries(4), yet, there is a dearth of data on dietary intake of sugars by this population. The objective of this research was to assess the intake of total and free sugars, and the contribution of food sources to free sugars intake, in a random sample of 11–13-year-old schoolchildren in Delhi, India. The study was approved by The University of Adelaide Human Research Ethics Committee and the Independent Ethics Committee of the Centre for Chronic Disease Control, New Delhi. The target sample size of 360 was based on a ± 5% margin of error in estimated sugars intake. A statistician external to the research team generated a random sample of 150 schools stratified by district (n = 11). Schools were recruited in turn from the list until 10 schools had consented. Teachers shared study information with parents who were invited to complete an online consent form. Child assent was obtained before data collection. Participants recorded all food and drink consumed over three consecutive days, including one weekend day, in a food diary. The information recorded was entered into an online dietary assessment tool, Intake24 (Southeast Asia version), during an interview with each participant during which portion size was ascertained with reference to the database of over 2400 food photographs of more than 100 foods. The Intake24 database converted food and drink reported into the intake of total and free sugars through integrated food compositional tables. Of 514 pupils providing consent, 393 participants (76.5%) (169 girls, 224 boys) completed the study. In girls, the median (IQR) daily intakes of total and free sugars were 95.0 (70.1-120.2) g/day and 43.0 (28.1-68.5) g/day respectively. The corresponding values in boys were significantly higher at 104.0 (80.2-138.7) g/day and 53.1 (34.1-76.5) g/day (p = 0.004). No between-gender difference was observed in the median percent contribution of sugars to E: total and free sugars contributed 14.9% (IQR 11.4-18.1%) and 7.1% (IQR 4.8-10.1%) respectively. The percent contribution of the main sources of sugars to free sugars intake were: (i) Sugars Preserves and Syrups (31.2% (IQR. 9.6-51.7%)); (ii) Cakes and Biscuits (13.7% (IQR 0-26.4%)); (iii) Desserts (5.4% (0-17.5%)) and (iv) Sugar-Sweetened Beverages and Juices (2.1% (IQR 0-15.7%)). In conclusion, in this sample of 11-13-year-old schoolchildren from Delhi, free sugars intake was above the WHO <5% E threshold. Forms of sugars that are added to foods by the consumer made the largest contribution to intake.

Prevalence and biological characteristics of acne in adult women employees of a university

Background: Increasingly observed in adulthood, adult female acne is considered a common chronic inflammatory disease of the pilosebaceous unit, presenting polymorphic lesions, risk of sequelae and negative impact on quality of life. This is a disease that may persist from adolescence (persistent acne) or manifest de novo in adulthood (late onset acne). Its etiology is multifactorial, and most of patients don’t have any abnormality in plasma androgen levels. Objectives: To investigate the prevalence and biological characteristics of acne in adult women, over 25 years, employees of a university in Sao Paulo, Brazil. Material and Methods: Project approved by Institutional Review Board. All participants signed online Consent Form and Authorization for Photography. This was a cross-sectional online study by using a questionnaire which was uploaded at the intranet of the university. It was sent and visualized by 2560 women employees, but just 241 filled the 59 questions. The data are presented in a descriptive way, in number and percentage. Results: We’ve received 9.4% of responses (241/2560); acne was reported by 94.2% (227/241) and 87.2% (198/227) were still suffering from acne. The real prevalence of acne in that population may be estimated in 7.7% (198/2560); 96% of patients reported inflammatory lesions; 58% on face; 68.7% persistent and 8.5% late onset acne. Regarding the severity, 48.5% were mild, 44.9% moderate and 6.6% severe. Familial history of acne was present in 79% of the patients with persistent acne and 81% late onset acne. Polycystic ovary syndrome was observed in 35% of women with persistent acne, 15% have already been treated or were under treatment; on the contrary 21% presented late onset acne and 64% were treated. Psychological impact was reported by 39% of women with persistent acne and 46% used antidepressants. On the other hand, 8% of women with late onset declared psychological disturbances and 30% were in use of antidepressants. Stress was reported by 51% of women with late onset acne. Additionally, 54% and 68% of women with persistent and late onset acne, respectively, reported sleep disturbances. Our study showed that 60% and 55% of women with persistent and late onset, respectively, consumed a diet featuring a high glycemic load, preferably including sweets. Results about the use of skin care during the treatment (persistent X late onset acne) were quite similar: regular use of sunscreen (50% X 58%); moisturizers (30% X 43%) and cleanser for oily skin (42% X 47%). In addition, 32% X 26% were submitted to chemical peeling; 55% X 41% used oral antibiotic, 28% X 26% combined oral contraceptive, 11% X 19% oral spironolactone, and 22% X 13% oral isotretinoin. Conclusions: The prevalence of acne among adult women employees at a university from Sao Paulo, Brazil is high, and the biological characteristic of the disease corroborates many previous studies. It is important to highlight the predominance of persistent acne, mild to moderate, inflammatory lesions, frequent report of ovary polycystic syndrome with low level of medical care and sleep disturbances. The excessive use of oral antibiotics instead of hormonal treatment point out the need of medical education for the management of this disease that causes important negative impact in women’s quality of life.

Effects of the Kahramanmaras, Turkey 2023 earthquakes on balance perception, dizziness and post-traumatic stress: A relational screening model between subjective balance problems and post-traumatic stress

ObjectiveThe aim of the present study was to investigate the effects of the February 6, 2023, earthquakes in Turkey and recurrent aftershocks on balance and post-traumatic stress in surviving victims. MethodsOur study included 1004 participants aged 18–65 years who were exposed to the February 6 earthquakes and aftershocks in Turkey. After obtaining online consent from all participants, the Vertigo Symptom Scale (VSS), the Dizziness Handicap Index (DHI), and the Posttraumatic Post-Traumatic Disorder Checklist Scale (PCL-5) were administered online, and the interactions between the variable sets were examined using a correlational screening model. ResultsAs a result of the structural equation model established with the observed variables, it was found that VSS total scores had a statistically significant positive effect on PCL-5 (β1 = 0.56; p = 0.001 < 0.05). In addition, statistically significant positive high-level correlations were found between VSS and DHI (covVSS-DHI = 0.71), and a positive low level correlation with the number of days with dizziness (covVSS-number of days with dizziness = 0.34), and a positive low level correlation with frequency of days with dizziness (covVSS-frequency of days with dizziness = 0.37). A statistically significant positive low-level relationship was found between DHI and the number of days with dizziness (covDHI-number of days with dizziness = 0.34) and a positive low-level correlation between DHI and the frequency of days with dizziness (covDHI-frequency of days with dizziness = 0.29). ConclusionThe structural equation modeling analysis showed that post-traumatic stress disorder had a significant effect on balance and dizziness.

Prevalence of fatigue and cognitive impairment after traumatic brain injury.

Following traumatic brain injury (TBI) some patients develop lingering comorbid symptoms of fatigue and cognitive impairment. The mild cognitive impairment self-reported by patients is often not detected with neurocognitive tests making it difficult to determine how common and severe these symptoms are in individuals with a history of TBI. This study was conducted to determine the relative prevalence of fatigue and cognitive impairment in individuals with a history of TBI. The Fatigue and Altered Cognition Scale (FACs) digital questionnaire was used to assess self-reported fatigue and cognitive impairment. Adults aged 18-70 were digitally recruited for the online anonymous study. Eligible participants provided online consent, demographic data, information about lifetime TBI history, and completed the 20 item FACs questionnaire. A total of 519 qualifying participants completed the online digital study which included 204 participants with a history of TBI of varied cause and severity and 315 with no history of TBI. FACs Total Score was significantly higher in the TBI group (57.7 ± 22.2) compared to non-TBI (39.5 ± 23.9; p<0.0001) indicating more fatigue and cognitive impairment. When stratified by TBI severity, FACs score was significantly higher for all severity including mild (53.9 ± 21.9, p<0.0001), moderate (54.8 ± 24.4, p<0.0001), and severe (59.7 ± 20.9, p<0.0001) TBI. Correlation analysis indicated that more severe TBI was associated with greater symptom severity (p<0.0001, r = 0.3165). Ancillary analysis also suggested that FACs scores may be elevated in participants with prior COVID-19 infection but no history of TBI. Adults with a history of even mild TBI report significantly greater fatigue and cognitive impairment than those with no history of TBI, and symptoms are more profound with greater TBI severity.

Effectiveness of multimodal participant recruitment in SPARK, a large, online longitudinal research study of autism.

SPARK launched in 2016 to build a US cohort of autistic individuals and their family members. Enrollment includes online consent to share data and optional consent to provide saliva for genomic analysis. SPARK's recruitment strategies include social media and support of a nation-wide network of clinical sites. This study evaluates SPARK's recruitment strategies to enroll a core study population. Individuals who joined between January 31, 2018, and May 29, 2019 were included in the analysis. Data include sociodemographic characteristics, clinical site referral, the website URL used to join, how the participant heard about SPARK, enrollment completion (online registration, study consents, and returning saliva sample), and completion of the baseline questionnaire. Logistic regressions were performed to evaluate the odds of core participant status (completing enrollment and baseline questionnaire) by recruitment strategy. In total, 31,715 individuals joined during the study period, including 40% through a clinical site. Overall, 88% completed online registration, 46% returned saliva, and 38% were core participants. Those referred by a clinical site were almost twice as likely to be core participants. Those who directly visited the SPARK website or performed a Google search were more likely to be core participants than those who joined through social media. Being a core participant may be associated with the "personal" connection and support provided by a clinical site and/or site staff, as well as greater motivation to seek research opportunities. Findings from this study underscore the value of adopting a multimodal recruitment approach that combines social media and a physical presence.

The Struggle for Women's Rights: History, Present, and Future

This paper delves into the multifaceted journey of feminism, tracing its historical evolution and exploring its contemporary developments. The overarching goal of feminism has been to challenge and dismantle the traditional gender roles, advocating for equal rights between men and women. The feminist movement has evolved through four distinct waves, each addressing specific facets of gender inequality. The first wave focused on securing legal rights, while the second expanded its scope to include education, workplace equality, and reproductive rights. The third wave introduced the concept of intersectionality and the need to consider the experiences of women from diverse backgrounds. The fourth wave leverages technology and social media, aiming to address issues such as online harassment, body positivity, and consent. Contemporary feminism also faces challenges, including online debates between men and women, often rooted in misunderstandings of feminist goals. Despite these hurdles, the future of feminism remains bright. It encompasses key areas like achieving equal treatment of women in the workplace, safeguarding reproductive rights, improving education for women, and fostering global solidarity to combat gender inequality worldwide. The collective efforts of women from all corners of the globe signify a promising path toward a more equitable and inclusive future.

P162: Ageism among Lebanese Healthcare Workers and Students

Objective:Ageism, defined as stereotyping, prejudice, or discrimination against older people, is an emerging public health concern [1]. Ageist attitudes and behaviors in health care are found to negatively affect the physical and mental well-being of older individuals [2]. This study is the first to investigate ageism and its determinants in Lebanese healthcare settings.Methods:We diffused an online survey including the Fraboni Scale for Ageism (FSA) [3] and other variables to nurses, physicians, nursing, and medical students at an urban university hospital in Lebanon. We obtained online consent from participants prior to filling the survey. The study was approved by the Institutional Review Board of St. Georges Hospital University Medical Center (IRB-REC/O/066-21/3321).Results:We recruited 233 participants (47.2% medical students, 21.5% nurses, 20.6% physicians and 10.7% nursing students). Mean age was 29.2 (Standard Deviation—SD = 12) years. Almost two-thirds were female. Half the sample came from rural areas. Almost 60% currently live or have lived with an adult aged≥ 60 years. The FSA total score ranged between 33 and 87 (mean 58.9; SD 10.2). The mean/SD scores were 22.6 (4.5), 17.2 (3.2) and 19.1 (4.3) for the antilocution, discrimination and avoidance subscales of the FSA respectively. There was a positive correlation between age and FSA total score (p=0.041), in addition to discrimination and avoidance subscores (p=0.0001). Originating from rural areas was associated with significantly lower discrimination scores. Living or having lived with an older individual was associated with significantly lower overall ageism and discrimination scores. In addition, students (nursing and medical) were found to have lower ageist perceptions and attitudes compared to healthcare professionals (nurses and physicians). Table 1 shows the results of bivariate analyses performed. Regression analyses showed that only living or having lived with an older person remained significantly associated with lower ageism scores (p=0.036) after accounting for other covariables.Conclusions:Lower ageism was found among students compared to practicing nurses and physicians. Having lived with an older person was a protective factor against ageism. Specific anti-ageism interventions may need to be implemented to mitigate its impact in healthcare among students and practitioners.Table 1Bivariate analyses of FSA total score and subscores on covariates of interestFSA total score mean (SD)p-valueAntilocution subscore mean (SD)p-valueDiscrimination subscore mean (SD)p-valueAvoidance subscore mean (SD)p-valueGender0.380.39P=0.1P=0.99Men (n=73)57.98 (10.56)22.2 (5.1)16.67 (3.26)19.1 (4.36)Women (n=160)59.26 (10.09)22.76 (4.2)17.39 (3.03)19.11 (4.33)Origin0.0640.0620.0290.38Capital and suburbs (n=117)60.1 (10.2)23.1 (4.5)17.6 (3.03)19.35 (4.38)Rural Areas (n=116)57.6 (10.1)22.04 (4.36)16.7 (3.15)18.85 (4.28)Residence0.90.490.420.11Capital and suburbs (n=175)58.8 (10.36)22.71 (4.65)17.26 (3.1)18.85 (4.27)Rural Areas (n=58)59 (9.9)22.24 (3.88)16.88 (3.15)19.88 (4.44)Healthcare professional group0.050.20.250.017Students (nursing/medical) n=13557.76 (10.20)22.27 (4.72)16.96 (3.26)18.53 (4.15)Healthcare worker (nurses/physicians) n=9860.37 (10.13)23.03 (4.08)17.44 (2.89)19.9 (4.46)Exposed to adults ≥ 60 years old0.0820.570.0020.18No (n=98)60.2 (10.9)22.8 (4.9)17.9 (3.3)19.5 (4.3)Yes (n=135)57.9 (9.6)22.4 (4.1)16.6 (2.8)18.8 (4.3)

ARFID Genes and Environment (ARFID-GEN): study protocol

BackgroundThe Avoidant Restrictive Food Intake Disorder – Genes and Environment (ARFID-GEN) study is a study of genetic and environmental factors that contribute to risk for developing ARFID in children and adults.MethodsA total of 3,000 children and adults with ARFID from the United States will be included. Parents/guardians and their children with ARFID (ages 7 to 17) and adults with ARFID (ages 18 +) will complete comprehensive online consent, parent verification of child assent (when applicable), and phenotyping. Enrolled participants with ARFID will submit a saliva sample for genotyping. A genome-wide association study of ARFID will be conducted.DiscussionARFID-GEN, a large-scale genetic study of ARFID, is designed to rapidly advance the study of the genetics of eating disorders. We will explicate the genetic architecture of ARFID relative to other eating disorders and to other psychiatric, neurodevelopmental, and metabolic disorders and traits. Our goal is for ARFID to deliver “actionable” findings that can be transformed into clinically meaningful insights.Trial registrationARFID-GEN is a registered clinical trial: clinicaltrials.gov NCT05605067.

Utilization of online systems to promote youth participation in research: A methodological study.

Online surveys can align with youth's increased use of the internet and can be a mechanism for expanding youth participation in research. This is particularly important during the coronavirus disease 2019 (COVID-19) pandemic, when in-person interactions are limited. However, the advantages and drawbacks of online systems used for research need to be carefully considered before utilizing such methodologies. To describe and discuss the strengths and limitations of an online system developed to recruit adolescent girls for a sexual health research study and conduct a three-month follow up survey. This methodology paper examines the use of an online system to recruit and follow participants three months after their medical visit to evaluate a mobile sexual and reproductive health application, Health-E You/Salud iTuTM, for adolescent girls attending school-based health centers (SBHCs) across the United States. SBHC staff gave adolescent girls a web link to an online eligibility and consent survey. Participants were then asked to complete two online surveys (baseline and 3-month follow-up). Surveys, reminders, and incentives to complete them were distributed through short message service (SMS) text messages. Upon completing each survey, participants were also sent an email with a link to an electronic gift card as a thank-you for their participation. Barriers to implementing this system were discussed with clinicians and staff at each participating SBHC. This online recruitment and retention system enabled participant recruitment at 26 different SBHCs in seven states across the United States. Between September 2021 and June 2022, 415 adolescent girls were screened using the Qualtrics online survey platform, and 182 were eligible to participate. Of those eligible, 78.0% (n = 142) completed the baseline survey. Participants were racially, geographically, and linguistically diverse. Most of the participants (89.4%) were non-White, and 40.8% spoke Spanish. A total of 62.0% (n = 88) completed the 3-month follow-up survey. Limitations of this system included reliance on internet access (via Wi-Fi or cell service), which was not universally available or reliable. In addition, an individual unrelated to the study obtained the survey link, filled out multiple surveys, and received multiple gift cards before the research team discovered and stopped this activity. As a result, additional security protocols were instituted. Online systems for health research can increase the reach and diversity of study participants, reduce costs for research personnel time and travel, allow for continued study operation when in-person visits are limited (such as during the COVID-19 pandemic), and connect youth with research using technology. However, there are challenges and limitations to online systems, which include limited internet access, intermittent internet connection, data security concerns, and the potential for fraudulent users. These challenges should be considered prior to using online systems for research.

Evaluation of CTRL: a web application for dynamic consent and engagement with individuals involved in a cardiovascular genetic disorders cohort

There has been keen interest in whether dynamic consent should be used in health research but few real-world studies have evaluated its use. Australian Genomics piloted and evaluated CTRL (‘control’), a digital consent tool incorporating granular, dynamic decision-making and communication for genomic research. Individuals from a Cardiovascular Genetic Disorders Flagship were invited in person (prospective cohort) or by email (retrospective cohort) to register for CTRL after initial study recruitment. Demographics, consent choices, experience surveys and website analytics were analysed using descriptive statistics. Ninety-one individuals registered to CTRL (15.5% of the prospective cohort and 11.8% of the retrospective cohort). Significantly more males than females registered when invited retrospectively, but there was no difference in age, gender, or education level between those who did and did not use CTRL. Variation in individual consent choices about secondary data use and return of results supports the desirability of providing granular consent options. Robust conclusions were not drawn from satisfaction, trust, decision regret and knowledge outcome measures: differences between CTRL and non-CTRL cohorts did not emerge. Analytics indicate CTRL is acceptable, although underutilised. This is one of the first studies evaluating uptake and decision making using online consent tools and will inform refinement of future designs.

Effectiveness of nicotine salt vapes, cytisine, and a combination of these products, for smoking cessation in New Zealand: protocol for a three-arm, pragmatic, community-based randomised controlled trial

BackgroundCombining short-acting nicotine replacement therapy with varenicline increases smoking cessation rates compared with varenicline alone, but not all people tolerate these medications or find them helpful. We aim to investigate the therapeutic potential of an analogous combination, by evaluating the effectiveness, safety, and acceptability of combining nicotine salt e-cigarettes with cytisine, compared to nicotine salt e-cigarettes or cytisine only, on smoking abstinence at six months.MethodsA pragmatic, community-based, investigator-blinded, randomised superiority trial design will be utilised. Eligible participants will be people who smoke daily (N = 800, 90% power) from throughout New Zealand, who are: aged ≥ 18 years, motivated to quit in the next two weeks, able to provide online consent, willing to use e-cigarettes and/or cytisine, and have daily access to a mobile phone. Recruitment will utilise multi-media advertising. Participants will be randomised (3:3:2 ratio) to 12 weeks of: 1) e-cigarettes (closed pod system, 3% nicotine salt, tobacco flavour) plus cytisine; 2) e-cigarettes alone, or 3) cytisine alone. All groups will receive a six-month, text-message-based behavioural support programme. The primary outcome is self-reported, biochemically verified, continuous abstinence at six months post-quit date. Secondary outcomes, measured at quit date, then one, three, six, and 12 months post-quit date, include self-reported continuous abstinence, 7-day point prevalence abstinence, cigarettes smoked per day, withdrawal and urge to smoke, time to (re)lapse, treatment use and compliance, treatment crossover, dual-use, use of other cessation products, change in e-cigarette products, continuation of product use, acceptability, change in health state, health-related quality of life, change in body mass index, adverse events, and cost per quitter.DiscussionPragmatic trials are of particular value as they reflect the ‘real world’ impact of interventions. The trial will provide some of the first evidence on the effectiveness of combining nicotine salt e-cigarettes with cytisine for smoking cessation, in a country with strong tobacco control policy. Findings will be incorporated into relevant systematic reviews, informing practice and policy.Trial registrationNCT05311085 ClinicalTrials.gov. Registered 5th April, 2022.

#4011 LESSONS LEARNT FROM VIRTUAL RECRUITMENT TO A MULTICENTRE RANDOMISED CONTROLLED TRIAL EVALUATING A DIGITAL HEALTH INTERVENTION FOR CKD

Abstract Background and Aims The post-COVID era has seen an escalation in the use of digital health interventions (DHIs), which have the potential to provide a widely accessible and cost-efficient approach to aspects of health service delivery such as patient education. Robust effectiveness evaluation is essential for all novel interventions to enable appropriate and sustained implementation. We have developed an education/self-management DHI named “My Kidneys &amp; Me” (MK&amp;M) for chronic kidney disease (CKD). A multi-centre randomised controlled trial (RCT) (SMILE-K) with virtual study processes allowing for minimal face-to-face participant contact was conducted to pragmatically deliver and evaluate MK&amp;M. Here we report the recruitment metrics of SMILE-K to inform and improve future design of virtual trials and delivery of DHIs. Method The SMILE-K virtual study design involved outcome measures collected via an online survey, and 2:1 randomisation to intervention or control group The recruitment process is summarised in Figure 1. Briefly, eligible adult CKD patients were identified by their clinical teams and given or sent a study invitation. If interested, patients emailed the study team, who then sent sequential emailed links to: 1) the information sheet and consent form; 2) the baseline outcome measure survey; and 3) (if randomised to intervention), MK&amp;M. Results 26 hospital sites in England recruited to SMILE-K between May 2021 and December 2022. 6693 invitations were issued: 4942 (74%) by mail, 883 (13%) in-person, 616 (9%) by mail following remote consultation; and 252 (4%) by email. 13% (875/ 6693 invited) invitees expressed interest, of which 60% (533/875) consented. Of the 533 consented, 5% (265/4942) had been invited via mail, 14% (120/883) in-person, 17% (103/616) via mail following remote appointment, and 2% (5/252) via email. Of those consented, 80% (424/533) completed the baseline survey and were subsequently randomised. The mean age of recruited participants was 74 years (±9.0; range:20-88) and 94% were White British. The median time from expression of interest to consent was 1 day (IQR:0-5), and consent to randomisation was 6 days (IQR:2.5-11). Conclusion Our experience shows that a virtual strategy for DHI RCT recruitment provides the opportunity to reach a high number of eligible participants. However, only 13% of invited patients expressed interest, and just 7% were recruited into the study. Most invitations were sent via mail with no prior approach or explanation. This method resulted in a markedly lower response rate than invitations issued after discussion with a healthcare professional, either remotely or in-person, underlining the importance of personal contact. Substantial attrition occurred at the consent stage, indicating that reading the information sheet and completing the online consent form unassisted was a barrier. Despite the need for internet access and digital skills, there was a wide participant age range, including those in their 80s. However, we noted a disproportionate representation of White ethnicity. This highlights the need to embed specific strategies to engage minority ethnic communities and other disadvantaged groups in the design of DHIs and future virtual trials to maximise reach and access to their potential benefits.

Physically Inactive Undergraduate Students Exhibit More Symptoms of Anxiety, Depression, and Poor Quality of Life than Physically Active Students

The World Health Organization (WHO) recommends at least 150 min of moderate or vigorous activity (MVPA) per week for health benefits. However, meeting WHO guidelines for physical activity has been shown to be a great challenge for general populations and it may be even more difficult for undergraduate students due to elevated academic demand, thus negatively affecting general health status. Thus, this study investigated whether undergraduate students meeting WHO guidelines for physical activity show greater scores for symptoms of anxiety, depression, and poor quality of life than their counterparts not meeting guideline recommendations. Additionally, symptoms of anxiety, depression, and poor quality of life among academic areas were compared. This is a cross-sectional study. The participants were recruited through messaging apps or institutional e-mail. The participants filled out an online consent form, questionnaires to assess demographic and academic characteristics, the International Physical Activity Questionnaire, the Beck depression and anxiety inventory, and the short-form 36-item health survey questionnaire. The participants were classified as physically active (MVPA > 150 min/week) or inactive (MVPA < 150 min/week) according to WHO Guidelines. A total of 371 individuals were included in the analysis. Physically inactive students demonstrated higher scores of depression (17.96 vs. 14.62; 95% CI: -5.81 to -0.86; p = 0.0083) than physically active ones. SF-36 analyses revealed that physically inactive students had lower values in mental (45.68 vs. 52.77; 95% CI: 2.10 to 12.06; p = 0.0054) and physical (59.37 vs. 67.14; 95% CI: 3.24 to 12.30; p = 0.0015) domains compared with physically active ones. As for SF-36 subscales, physically inactive students showed lower scores in function capacity (70.45 vs. 79.70; 95% CI: 4.27 to 14.49; p = 0.0003), mental health (45.57 vs. 55.60; 95% CI: 5.28 to 14.76; p < 0.0001), social aspects (48.91 vs. 57.69; 95%CI: 3.47 to 14.08; p = 0.0012), vitality (42.19 vs. 50.61; 95% CI: 3.47 to 13.35; p = 0.0009), pain (61.85 vs. 68.00; 95% CI: 1.27 to 11.02; p = 0.0135), and general health status (53.82 vs. 63.81; 95% CI: 5.21 to 14.75; p < 0.0001) than their physically active peers. The findings suggest that undergraduate students who do not meet WHO guidelines for physical activity display higher scores of anxiety, depression, and poor quality of life in comparison with their counterparts meeting physical activity guidelines. Collectively, these data suggest the need for academic institutions and policy makers to monitor and promote in-campus interventions to encourage physical activity.

Social norms and goal-setting interventions to promote responsible gambling in low-to-moderate online gamblers: protocol for a four-arm randomised controlled feasibility study

IntroductionGambling is increasingly recognised as an important public health issue. Problem gambling is associated with highly negative impacts on physical, psychological and social well-being, not only for those who gamble...

“The secret is that the secret changes”: Sex and Taboo in India and Indian Young Adult Fiction

Mainstream film and media in India constantly expose children and young adults to sexually explicit, misogynistic, homophobic and transphobic content, while opposing the need for sex education in schools – a dichotomy which exposes a deep-rooted taboo regarding sex and sexuality education that perpetuates situations like the spate of gruesome rapes and child sexual abuse across the country in the last decade. To examine this paradox and its effects, this paper does a close reading of a few select contemporary young adult novels as a form of rebellion against prevalent taboos regarding sex and sexuality in India and a subversive mode of sexuality education among its young adult readers. Issues of slut-shaming, revenge porn and blackmail, online abuse and consent are predominant in these books and this paper explores the detrimental effects of this persistent taboo about sex among youth in India through these books – <em>Mayil Will Not be Quiet!</em> (2008), <em>Mostly Madly Mayil</em> (2013), <em>This is Me, Mayil</em> (2018), <em>Facebook Phantom</em> (2013), <em>Talking of Muskaan</em> (2014) and <em>The Lies We Tell</em> (2019) – and address the critical silence regarding Sex and Young Adults in India. It attempts to do so by studying the texts against the definitions and development of the taboos and prejudices about sex and sexuality across Indian history and culture which continue to be used in the argument against the need for sex education for young adults, which this paper reads as an act of exerting power to control the private lives and personal choices of minors.