Consent Rate Research Articles

Further development and validation of the Multimorbidity Treatment Burden Questionnaire (MTBQ)

ObjectivesTo undertake further psychometric testing of the Multimorbidity Treatment Burden Questionnaire (MTBQ) and examine whether reversing the scale reduced floor effects.DesignSurvey.SettingUK primary care.ParticipantsAdults (≥18 years) with three or more long-term...

Abstract 3889: Genomic landscape of gynecologic cancers with poor prognosis in Japan, an analysis of the national database of comprehensive genomic profiling tests

Abstract Objective: Comprehensive genomic profiling (CGP) tests were approved in Japan in June 2019 under universal health insurance coverage for cancer patients who have finished (or almost finished) standardized treatment. All the data are collected to the “Center for Cancer Genomics and Advanced Therapeutics (C-CAT)” under written informed consent. Up to date, over 60,000 CGP data have been deposited with a 99.7% consent rate. This study aims to analyze mutational landscape of gynecologic cancers, especially with poor prognosis, by using this database. Methods: We analyzed CGP datasets from 3,006 gynecologic cancer patients using FoundationOne® CDx (F1CDx), the most commonly tested in Japan. This study was ethically approved by our institutional ethics committee (#2021341G) and the Information Utilization Review Board of C-CAT (#CDU2022-026N). Results: Endometrial cancers (n=561) showed high rates of tumor mutational burden-high (TMB-H) (13.9%) and MSI-high (MSI-H) (10.8%), especially in endometrioid carcinomas. POLE exonuclease mutations were less frequent (1.4%) compared to TCGA data (7%), while TP53 mutations were more common (54.4% vs. 29% in TCGA), suggesting the impact of prognosis of the molecular subtypes. Other frequently mutated genes included PIK3CA (41%), PTEN (35%), ARID1A (31%) and KRAS (26%). In 839 cervical cancers, TMB-H prevalence was 14.2%, with low MSI-H at 1.5%. TMB-H was significantly higher in squamous cell carcinomas (20.6%) than adenocarcinomas (8.3%). Frequent mutations included PIK3CA (32%), STK11 (20%), TP53 (20%), KRAS (14%), and CDKN2A (11%). TP53 mutations were significantly higher than TCGA data (<5%), particularly in mucinous carcinomas (60%), indicating a prevalence of HPV-independent tumors with poorer prognosis. Actionable mutations were generally more frequent in adenocarcinomas than in squamous cell carcinomas, including KRAS (32.2%), TP53 (29.4%), CDKN2A (18.3%), and ERBB2 (16.7%). In 1,606 ovarian cancers, the ratio of TMB-H was 5.0%, and MSI-H was 1.2%. TMB-H rates varied between 3.3-6.5% across histological types, while the ratio of MSI-H was significantly lower in serous carcinomas (0.3%) than non-serous carcinomas. Pathogenic mutations in the POLE exonuclease domain were rare in cervical (0.0%) and ovarian (0.2%) cancers. Conclusion: The C-CAT database offers insights into the mutational landscape of various cancers and histological subtypes, especially those with poor prognosis, highlighting the unmet needs for drug development in these gynecologic cancers. Citation Format: Qian Xi, Hidenori Kage, Miho Ogawa, Asami Matsunaga, Akira Nishijima, Kenbun Sone, Kei Kawana, Katsutoshi Oda. Genomic landscape of gynecologic cancers with poor prognosis in Japan, an analysis of the national database of comprehensive genomic profiling tests [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 3889.

Implementation of the e-IPOS in Home Palliative Cancer Care: A Quasiexperimental Pilot Study.

Electronic patient-reported outcome measures (e-PROMs) offer advantages in palliative cancer care, including rapid completion, improved data quality and direct storage, improving clinical decision-making. The electronic Integrated Palliative Care Outcome Scale (e-IPOS) in this context enables thorough self-assessment by patients, enhancing symptom management and self-reflection of their current situation. To evaluate the feasibility of implementing the e-IPOS in home palliative cancer care. The primary outcomes included the enrollment consent rate, study retention rate, e-IPOS completion rate and response completeness, and the number of clinical assessments and interventions performed during home visits. The secondary outcomes were the number of unscheduled visits and patients' perceived quality of life. A two-group quasiexperimental clinical pilot study. The control group received standard palliative care, the intervention group received standard care along with weekly e-IPOS completion during home visits. Both groups were enrolled for 4weeks. Adults with advanced cancer from the home palliative care unit of the Istituto Nazionale dei Tumori of Milan. Twenty-three patients were enrolled (74.19%), and 20 completed the study (drop-out: 13.04%). 82.5% of the expected e-IPOS responses were received, of which 96.9% were fully complete. In the intervention group, the Wilcoxon test showed an increase in identified needs and documented interventions (P < .05) and a decrease in unscheduled visits (P < .05). It is feasible to recruit people via home palliative care for an e-IPOS implementation study. Future fully powered studies should investigate the feasibility and assess patients' perceptions of its use to better understand its clinical benefits.

Text Message-Based Cessation Intervention for People Who Smoked or Used Smokeless Tobacco in India: A Feasibility Randomized Controlled Trial.

Despite the high burden of tobacco use in India, users do not have access to adequate help. This pilot trial aimed to evaluate the feasibility and acceptability of a text messaging intervention for tobacco cessation, generate preliminary estimates of its impact, and fine-tune procedures for a definitive trial. Parallel two-arm single blind individually randomized controlled pilot trial with nested qualitative study. Participants included adult current tobacco users (smoked and smokeless). Eligible and consenting participants were randomized to receive either (1) text messaging intervention (ToQuit) which covered specific content areas such as psychoeducation about consequences of tobacco use and benefits of quitting and tobacco avoidance strategies or (2) information about tobacco cessation helplines such as the helpline number and the languages in which tobacco cessation support was available (control). Feasibility data included screening and consent rates, treatment dropouts, and outcome ascertainment. The primary abstinence outcome was self-reported abstinence from tobacco in the past seven days at 3 months post-randomization. In-depth interviews were conducted with a subsample of participants primarily to collect acceptability data. The primary abstinence analysis used a chi-squared test and logistic regression (complete case), and qualitative data was analyzed using thematic analysis. Ninety-eight participants were randomized into the two trial arms; 77 (79%) completed outcome evaluation. No between-arm differences in abstinence were found though findings favored the intervention (7-day abstinence: ToQuit 23%, control 19%; adjusted odds ratio 1.23, 95% confidence interval 0.38, 3.97). Participants appreciated the language, comprehensibility, and relevance of the messages; and reported overall satisfaction with and positive impact from the intervention on their lives. The findings indicate the acceptability and feasibility of ToQuit and if found effective, it could be a potentially scalable first-line response to tobacco use in low-resource settings. Our pilot randomized control trial provides sufficient findings supporting the acceptability and feasibility of an intervention for tobacco cessation which is suitable for a context which has a shortage of healthcare workers and for individuals who use smoked or smokeless tobacco. This is critical on a background of limited contextually relevant interventions for a problem with a high burden in low- and middle-income countries such as India.

Exploring attitudes and variation by sociodemographic factors in consent provided for financial data linkage in an experimental birth cohort study

BackgroundImproving our understanding of household incomes and what constitutes financial insecurity can help us to better understand how financial insecurity is experienced and how this can change over time within and between individuals and populations. However, financial circumstances are often perceived as sensitive and stigmatising, particularly within some ethnic minority groups. This research aims to explore attitudes and variation by sociodemographic factors in consent provided for financial data linkage in an experimental birth cohort study, in order to obtain validated income and benefits data and to better understand the impact of community interventions on the financial security of its participants and their families.MethodsThis research utilises an observational study design to explore consent rates, attitudes and variation in sociodemographic factors between participants of an experimental birth cohort in a deprived and ethnically diverse setting who consent and do not consent to financial data linkage.ResultsOverall, participants were equally likely to consent and decline consent for financial data linkage. Measures of socioeconomic insecurity were associated with being more likely to provide consent for financial data linkage. Participants who were not employed (OR 1.49 95% CI 0.93, 2.40) and were more financially insecure (OR 1.85 95% CI 1.14, 3.93) were more likely to provide consent for financial data linkage. Where the participant’s first language was a language other than English, participants were also less likely to provide consent for data linkage (OR 0.65 95% CI 0.39, 0.98). The choice of consent for financial data linkage was not associated with: ethnicity; relationship factors; employment status of the participant’s partner; person present at time of recruitment; and measures of health, such as general health, mental health, wellbeing and health-related quality of life.ConclusionsThis research sets out an approach to obtaining validated income and benefits data, as a proxy measure for financial security, within an experimental birth cohort study in a deprived and ethnically diverse setting. It achieves good consent rates and demonstrates greater input from those who report greater potential need for financial support. Further research should be conducted to further understand the interplay of language spoken in this context.

Video feedback for young babies and maternal perinatal mental illness: intervention adaptation, feasibility and acceptability.

We aimed to adapt, pilot and explore experiences of receiving and delivering the video feedback intervention for positive parenting (VIPP) for 2 to 6 month old babies, mothers experiencing moderate to severe perinatal mental health difficulties and perinatal mental health clinicians. The VIPP intervention was adapted to include developmentally appropriate activities and developmental psychoeducation for 2 to 6 month olds, alongside psychoeducation on emotion regulation, and then piloted in 14 mothers experiencing moderate to severe perinatal mental health difficulties (registration ISRCTN64237883). Observational and self-reported pre-post outcome data on parenting and parent-infant mental health was collected, and post-intervention qualitative interviews were conducted with participating mothers and clinicians. Consent (67%), intervention completion (79%) and follow-up rates (93%) were high. Effect sizes on pre-post outcome measures indicated large improvements in parenting confidence and perceptions of the parent-infant relationship, and a medium-size improvement in maternal sensitivity. In qualitative interviews, clinicians and mothers described how mothers' initial anxieties about being filmed were allayed through receiving positive and strengths-focussed feedback, boosting their self-confidence, and that the video feedback facilitated identification of young babies' subtle behavioural cues and moments of mother-infant connection. Streamlining the information provided on maternal emotion regulation, and allowing increased use of clinical judgement to tailor intervention delivery, were suggested to optimise intervention feasibility and acceptability. It is feasible and acceptable to implement VIPP with very young babies and their mothers experiencing perinatal mental health difficulties. A fully powered randomised controlled trial is required to establish intervention efficacy.

Dyadic Yoga for Head and Neck Cancer Patients Undergoing Chemoradiation and their Family Caregivers

ObjectivesConcurrent chemoradiation to treat head and neck cancer (HNC) may result in debilitating toxicities. Targeted exercise such as yoga therapy may buffer against treatment-related sequelae; thus, this pilot RCT examined the feasibility and preliminary efficacy of a yoga intervention. Because family caregivers report low caregiving efficacy and elevated levels of distress, we included them in this trial as active study participants. MethodsHNC patients and their caregivers were randomized to a 15-session dyadic yoga program or a waitlist control (WLC) group. Prior to randomization, patients completed standard symptom (MDASI-HN) and patients and caregivers completed quality of life (SF-36) assessments. The 15-session program was delivered parallel to patients’ treatment schedules. Participants were re-assessed at patients’ last day of chemoradiation and again 30 days later. Patients’ emergency department visits, unplanned hospital admissions and gastric feeding tube placements were recorded over the treatment course and up to 30 days later. ResultsWith a consent rate of 76%, 37 dyads were randomized. Participants in the yoga group completed a mean of 12.5 sessions and rated the program as “beneficial.” Patients in the yoga group had clinically significantly less symptom interference and HNC symptom severity and better QOL than those in the WLC group. They were also less likely to have a hospital admission (OR = 3.00), emergency department visit (OR = 2.14), and/or a feeding tube placement (OR = 1.78). ConclusionYoga therapy appears to be a feasible, acceptable, and possibly efficacious behavioral supportive care strategy for HNC patients undergoing chemoradiation. A larger efficacy trial is warranted.

The Gestational Obesity Weight Management: Implementation of National Guidelines (GLOWING) study: a pilot cluster randomised controlled trial

BackgroundPregnancy weight management interventions can improve maternal diet, physical activity, gestational weight gain, and postnatal weight retention. UK guidelines were published in 2010 but health professionals report multiple complex barriers to practice. GLOWING used social cognitive theory to address evidence-based barriers to midwives’ implementation of weight management guidelines into routine practice. This paper reports the pilot trial outcomes relating to feasibility and acceptability of intervention delivery and trial procedures.MethodsGLOWING was a multi-centre parallel-group pilot cluster RCT comparing the delivery of a behaviour change intervention for midwives (delivered as training workshops) with usual practice. The clusters were four NHS Trusts in Northeast England, randomised to intervention or control arms. Blinding of allocation was not possible due to the nature of the intervention. We aimed to deliver the intervention to all eligible midwives in the intervention arm, in groups of 6 midwives per workshop, and to pilot questionnaire data collection for a future definitive trial. Intervention arm midwives’ acceptability of GLOWING content and delivery was assessed using a mixed methods questionnaire, and pregnant women’s acceptability of trial procedures by interviews. Quantitative data were analysed descriptively and qualitative data thematically.ResultsIn intervention arm Trusts, 100% of eligible midwives (n = 67) were recruited to, and received, the intervention; however, not all workshops had the planned number of attendees (range 3–8). The consent rate amongst midwives randomised (n = 100) to complete questionnaires was 74% (n = 74) (95% CI 65%, 83%), and overall completion rate 89% (n = 66) (95% CI 82%, 96%). Follow-up response rate was 66% (n = 49) (95% CI 55%, 77%), with a marked difference between intervention (39%, n = 15) and control (94%, n = 34) groups potentially due to the volume of research activities. Overall, 64% (n = 47) (95% CI 53%, 75%) completed both baseline and follow-up questionnaires. Midwives viewed the intervention as acceptable and directly relevant to routine practice. The least popular components related to scripted role-plays. Pregnant women viewed the recruitment and trial processes to be acceptable.ConclusionsThis rigorously conducted pilot study demonstrated feasibility intervention delivery and a high level of acceptability amongst participants. It has provided information required to refine the intervention and trial protocol, enhancing confidence that a definitive trial could be carried out.Trial registration ISRCTN46869894; retrospectively registered 25th May 2016, www.isrctn.com/ISRCTN46869894.

A community-based advanced nurse practitioner-led integrated oncology care model for adults receiving oral anticancer medication: a pilot study

Oral anti-cancer medications (OAMs) are being used increasingly within cancer care. OAMs offer the potential to improve patient convenience and increase hospital capacity. The clinical assessment for each cycle of OAMs requires specialist patient review often performed in hospital-based oncology units. Consequently, any potential improvement in patient expediency or increased hospital capacity that OAMs can offer is not realised. This study aimed to develop and pilot the specialist assessment of patients receiving OAMs by an Advanced Nurse Practitioner (ANP) in a community-based location.The primary aim of this pilot study was to assess the feasibility of a community-based ANP-led integrated oncology care model for adults receiving OAMs in Ireland who met the pre-specified eligibility criteria. The objectives were to determine the feasibility of a definitive trial of this intervention by measuring patient safety, acceptability to patients and staff and cost of the new model of care.This single-centre pilot study provided patient care (n = 37) to those receiving OAM therapies within a community setting for a 4-month period. Consent rate was high with no attrition other than for clinical reasons. There were 151 contacts with the sample during that time.Results demonstrated that the ANP-led intervention and new model for OAM care was safe, highly acceptable to patients and staff and that related healthcare costs could be captured. Based on the success of this pilot study, the authors conclude that a community-based ANP-led integrated oncology care model for adults receiving OAMs is feasible, and a definitive trial is warranted.Trial registration ISRCTN, ISRCTN10401455. Registered 30 November 2020.

Development of A Micro-CT Scanner with Dual-Energy Option and Endovascular Contrast Agent Administration Protocol for Fetal and Neonatal Virtual Autopsy.

The rate of parental consent for fetal and perinatal autopsy is decreasing, whereas parents are more likely to agree to virtual autopsy by non-invasive imaging methods. Fetal and perinatal virtual autopsy needs high-resolution and good soft-tissue contrast for investigation of the cause of death and underlying trauma or pathology in fetuses and stillborn infants. This is offered by micro-computed tomography (CT), as opposed to the limited resolution provided by clinical CT scanners, and this is one of the most promising tools for non-invasive perinatal postmortem imaging. We developed and optimized a micro-CT scanner with a dual-energy imaging option. It is dedicated to post-mortem CT angiography and virtual autopsy of fetuses and stillborn infants in that the chamber can be cooled down to around 5 °C; this increases tissue rigidity and slows decomposition of the native specimen. This, together with the dedicated gantry-based architecture, attempts to reduce potential motion artifacts. The developed methodology is based on prior endovascular injection of a BaSO4-based contrast agent. We explain the design choices and considerations for this scanner prototype. We give details of the treatment of the optimization of the dual-energy and virtual mono-energetic imaging option that has been based on minimizing noise propagation and maximizing the contrast-to-noise ratio for vascular features. We demonstrate the scanner capabilities with proof-of-concept experiments on phantoms and stillborn piglets.

Community Outreach and Engagement in Cancer Research Through a Biobank Clinic at Shaukat Khanum Memorial Cancer Hospital and Research Centre, Pakistan.

Cancer's increasing prevalence across the globe emphasizes the urgency for continued research, prevention, and accessible healthcare to mitigate its impact on individuals and communities. While there have been significant advances made towards controlling cancermorbidity and mortality in recent decades, Pakistan continues to experience a markedly elevated burden of the disease. With this study, we aim to raise awareness about biobank research within the cancer patient community, fostering participation and collaboration to advance the fight against cancer through vital research contributions. In October 2022, we initiated the biobank clinic at Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH&RC). Here, patients underwent screening and received invitations to voluntarily participate in biobank research. During these interactions, we engaged patients in discussions about the significance of biobank research, addressed their concerns, and encouraged their participation in advancing our research endeavors. Two-sample independent t-tests were performed to compare the mean number of participants in pre-clinic and post-clinic cohorts. This research involved a total of 958 participants, with 312 participants enrolled before the clinic and 646 participants enrolled after the clinic. We have observed a noticeable increase in the participation of cancer patients in our research endeavors since the inception of the biobank clinic (p-value<0.001). Over an 11-month time frame, we scheduled appointments for 759 patients, and out of those, 656 patients availed themselves to visit the clinic. Impressively, we achieved the enrollment of 646 patients into the clinic, reflecting an exceptional consent rate of 98.47% for their active involvement in our research initiatives. This underscores our commitment to conducting comprehensive discussions and providing thorough explanations regarding the ethical and procedural aspects of our research. Biobank clinic plays a pivotal role in raising cancer awareness and fostering research participation, especially in regions with limited healthcare infrastructure and lower literacy rates. It emerges as a community-engagement model that aligns research with local needs, ensuring its relevance and benefit to the population.

The Effects of Placement and Order on Consent to Data Linkage in a Web survey

Abstract We report on an experiment in a supplemental web survey as part of a longitudinal study in the United Kingdom where we ask survey respondents to consent to two forms of data linkage to health records and to consent to be mailed a serology kit. We varied the placement (early, early in context, or late in the survey) and order (linkage first or serology first) of the consent requests. We also examine reasons for consent or non-consent. We find that order of the requests does not make much difference, but making the requests early in the survey significantly increases consent rates over asking them after a series of content-related questions (by 3.4 percentage points) or later in the survey (by 7.2 percentage points). This is consistent with previous research showing that early requests for consent in a survey have a positive effect. The main reason chosen for not consenting related to the personal nature of the information requested.

Behavioural change for Parkinson's Disease: A randomised controlled feasibility study to promote physical activity and exercise adherence among people with Parkinson's: study protocol.

Parkinson's is a common progressive neurological condition characterized by motor and non-motor deficits. Physical activity and exercise can improve health, but many people with Parkinson's (PwP) have trouble reaching the recommended dosage. Our recent literature review found improvements in exercise adherence with behavioural change interventions, but it remains unclear which are most effective. Further qualitative research and patient and public involvement has informed a novel behavioural change intervention to be tested alongside an existing exercise program. To examine the feasibility of behavioural change techniques delivered alongside an exercise programme to improve physical activity, function, and self-efficacy in PwP (and study procedures) to inform a future pilot RCT trial. A parallel-arm single blinded randomised feasibility study. Twenty participants with Parkinson's (Hoehn and Yahr stage 1-3) will be recruited from a physiotherapy primary-care waiting list. Following written consent, and baseline assessment, the participants will be randomly allocated to the intervention (n=10) or the control group (n=10). Both groups will receive usual care, which includes a weekly program of a multidisciplinary education, a supervised exercise class and a prescribed home exercise program. The intervention group will receive additional behavioural change techniques, targeting behaviour regulation, belief about capabilities and social influences. Class and home exercise adherence, behavioural component uptake and adherence, and negative events will be recorded. Outcomes will include enrolment and maintenance rates, physical function, falls, physical activity, and exercise self-efficacy measured pre- and post- the 12-week program (in-person). Surveys will be used to compare experiences and satisfaction between groups. Exit interviews will be completed with the intervention group only, exploring their experience of the behavioural change techniques. The results will help inform a future pilot RCT, based on the intervention acceptability, consent rate, maintenance, and protocol integrity. ClincialTrials.gov NCT06192628.

"ReachOut": Pilot Evaluation of a Help-Seeking Intervention for Common Mental Health Concerns Among Distressed Non-Treatment-Seeking Young Adults.

Purpose There is a pressing need for interventions with the potential for scalability to enhance help-seeking inclination and behavior among individuals experiencing common mental health concerns. These interventions are important for addressing the widespread treatment gap. This study aimed to test the effectiveness, feasibility, and acceptability of a newly developed simple technology-based multi-component help-seeking intervention ("ReachOut") for common mental health concerns among distressed, non-treatment-seeking young adults. Methods "ReachOut" was delivered to 172 young adults aged 20-35 years, scoring above the cut-off on the Kessler Psychological Distress scale. Effectiveness was studied using a single-group short-term prospective study design to examine changes in help-seeking barriers, inclination, and behavior. We assessed intervention feasibility in terms of demand, implementation, practicality, and limited efficacyand acceptability was determinedbased on the rate of participation consent, the extent of pro-active initiation of contact with the facilitatorduring the intervention, feedback obtained on various "ReachOut" componentsand ratings on the likelihood of recommendingthe interventiontoa person in distress. Results Significant reductions in the mean barriers and improvement in mean help-seeking inclination from mental health professionals (MHPs) were observed on the Friedman test from baseline to the two-month follow-up period after the intervention. Thirty-eight percent of participants (N=41) reported seeking help from MHPs by two-month follow-up. Feedback from participants, assessments, and observations indicated that "ReachOut" was feasible and acceptable among the target sample. Conclusions The study provides preliminary evidence of the effectiveness, feasibility, and acceptability of the help-seeking intervention "ReachOut" in reducing barriers and improving help-seeking inclination and behavior for common mental health concerns among distressed non-treatment-seeking young adults.

The Connected We St@nd programme: A feasibility pilot study of an online self-management intervention for adults on in-centre haemodialysis and family caregivers.

The 'Connected We St@nd' is an online self-management intervention programme for people receiving in-centre haemodialysis and family caregivers that combines an educational and psychosocial support component. This study aimed to evaluate its feasibility and acceptability before proceeding to a large-scale trial. This was a pre-post single-arm feasibility pilot study conducted with adults undergoing in-centre haemodialysis and family caregivers. Feasibility was based on eligibility, consent, retention, completion and intervention adherence rates, while acceptability was assessed in post-intervention focus group interviews. Twenty-six people (16 adults on haemodialysis and 10 family caregivers) recruited through social networks completed the intervention. Consent, retention and completion rates were excellent (>90%) and eligibility (77.5%) and intervention adherence were satisfactory (69% for the psychosocial support sessions). Qualitative findings revealed that participants shared positive feelings regarding their participation in the programme. The valuable interactions with group peers and health psychologists during the support sessions, the perception of the adequacy and coherence of the programme's contents and materials and the participants' confidence in using the platform developed to deliver the intervention were some of the aspects highlighted as facilitators of intervention acceptability. Additionally, people on haemodialysis and caregivers reported that participation in the programme brought several educational and emotional benefits (e.g., additional disease-related knowledge, improved communication and coping skills, greater confidence in managing dialysis complications or caregiving demands) that helped increase their self-management skills and psychosocial adjustment to the demands of kidney failure and renal therapies. The results suggested that the 'Connected We St@nd' programme is likely to be feasible and acceptable for adults on haemodialysis and family caregivers, thus representing a promising resource for the future of interdisciplinary renal rehabilitation. Suggestions were made to fine-tune the intervention design to proceed with a large-scale trial.

Development of an App for Symptom Management in Women With Breast Cancer Receiving Maintenance Aromatase Inhibitors: Protocol for a Mixed Methods Feasibility Study.

Patients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer often experience a reduced quality of life after primary treatment. The disease and treatment trajectory consists of surgery followed by chemotherapy or radiation therapy. Upon this, maintenance hormone therapy with an aromatase inhibitor can result in several physical and psychosocial symptoms. Optimal symptom control during maintenance therapy is central to maintaining the patient's quality of life. This study aims to (1) develop an electronic symptom management tool for patients with postmenopausal early breast cancer receiving maintenance aromatase inhibitors with an endocrine aspect and (2) assess the feasibility, acceptability, and usability of the pilot version of the Bone@BC app. Furthermore, longitudinally, symptom prevalence and quality of life for patients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer will be explored. This study follows a multistage research plan. In stage 1, a systematic literature review to establish an overview of aromatase inhibitor-related symptoms reported by postmenopausal women with nonmetastatic estrogen receptor-positive breast cancer will be completed. In stage 2, a comprehensive overview of symptoms related to aromatase inhibitors (letrozole, exemestane, and anastrozole) will be performed (eg, by reviewing medical leaflets and guidelines). In stage 3, an electronic app with a user-friendly Patient Concern Inventory list to comprise symptoms and concerns will be developed. Last, in stage 4, a convergent mixed methods feasibility study of the pilot version of the Bone@BC app will be conducted. A total of 45 patients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer will use the app daily for symptom identification and respond to 6 serial patient-reported outcome measurements for 12 weeks. Finally, semistructured interviews will be performed. The primary outcome includes consent rate, attrition rate, retention rates, technical issues, and adherence, assessed using preestablished criteria on feasibility and a mixed methods approach for exploring acceptability. A patient advisory board consisting of 5 women with breast cancer is recruited to include their perspectives and experiences in the planning, organization, implementation, and dissemination of the research throughout the project. At the time of submitting this paper (January 2024), a total of 23 patients have been included in the stage 2 medical audit over the recruitment period of 3 months (November 2022 to February 2023), and 19 patients have been enrolled in stage 2, the semistructured patient interviews. This protocol describes a study investigating the feasibility, acceptability, and usability of the symptom management tool Bone@BC developed for patients with breast cancer with an endocrine aspect. ClinicalTrails.gov NCT05367830; https://clinicaltrials.gov/ct2/show/NCT05367830. DERR1-10.2196/49549.

Implementing consultation audio recording applications to improve informed decision-making (IDM) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) eligible for docetaxel.

103 Background: Pts with mCRPC have multiple treatment options and face challenges to IDM. This leads some to make poorly informed or goal-discordant decisions. Consultation audio recordings are known to improve IDM by improving recall, but uptake has been limited. It is unclear whether pt-administered apps are an effective, feasible strategy to increase access to recordings and improve IDM. Methods: We conducted a single-site implementation trial. Pts were English-speaking with progressive mCRPC and an upcoming oncology visit in which treatment options including docetaxel would be discussed. Pre-visit, a coordinator sent instructions, provided coaching, and sent text reminders to help pts create recordings using their mobile device. To evaluate change in IDM pre- vs post- the audio-recorded visit, we used an investigator-developed questionnaire testing pt knowledge about docetaxel (19 items, 0-100% correct) and the decisional conflict scale-informed subscale (3 items, 0=feels extremely uninformed to 100=feels extremely informed). Change was evaluated using the Wilcoxon signed-rank test. We also measured implementation: rates of consent, instruction receipt, recording, and listening, as well as pt-reported helpfulness of the app in decision-making. Lastly, we interviewed pts to understand benefits, barriers, and facilitators. Results: Of 78 pts approached, 44 (56%) consented, and 41 (53%) were evaluable. Top reasons for not consenting were too busy (7, 21%), illness (5, 15%), and inadequate devices (4, 12%). Mean age was 75y [56-90], and 34 (83%) were White. Median knowledge about docetaxel increased from 47 to 53 (P=0.048), corresponding to one additional correct response. Median informed subscore increased from 50 to 75 (P=0.011), corresponding to an improvement from feeling neither informed nor uninformed to feeling informed. All pts received instructions, 38 (93%) recorded their visits, and 28 (68%) listened to the recording. Twenty-six pts (63%) found the app helpful in decision-making. In pt interviews, benefits of recording were better recall of treatment options and toxicities, greater decision confidence, and peace of mind. Most frequently reported barriers to use were technology unfamiliarity and disconnected pt portal, telehealth, and recording applications; facilitators were app simplicity and caregiver/coordinator assistance. Conclusions: Implementation of self-administered mobilerecordings was feasible and associated with increased pt knowledge and feeling more informed about treatment with docetaxel in pts with mCRPC. Future efforts should focus on non-White, no/limited-English-speaking populations, and increasing recording/listening rates by addressing barriers and augmenting facilitators (e.g., integrating recordings in electronic pt portals). Clinical trial information: NCT05127850 .

Comparison of the safetyand efficacyfor different regimens of pharmaco-prophylaxis among severely burned patients: a randomized controlled trial.

Venous thromboembolism (VTE) is a common complication in critically ill patients, including severe burn cases. Burn patients respond differently to medications due to pharmacokinetic changes. This study aims to assess the feasibility and safety of different VTE pharmaco-prophylaxis in patients admitted to the ICU with severe burns. A pilot, open-label randomized controlled trial was conducted on ICU patients with severe burns (BSA ≥ 20%). By using block randomization, patients were allocated to receive high-dose enoxaparin 30mg q12hours (E30q12), standard-dose enoxaparin 40mg q24hours (E40q24), or unfractionated heparin (UFH) 5000 Units q8hours.In this study, the primary outcomes assessed were the recruitment and consent rates, as well as bleeding or hematoma at both the donor and graft site. Additionally, secondary measures were evaluated to provide further insights. Twenty adult patients out of 114 screened were enrolled and received E30q12 (40%), E40q24 (30%), and UFH (30%). The recruitment rate was one patient per month with a 100% consent rate. Donor site bleeding occurred in one patient (16.7%) in the UFH group. On the other hand, graft site bleeding was only reported in one patient (12.5%) who received E30q12. Major bleeding happened in two patients, one in E30q12 and one in the UFH group. Five patients (25.0%) had minor bleeding;two patients (25.0%) received E30q12, two patients E40q24, and onepatient UFH. RBC transfusion was needed in four patients, two on E30q12 and two on UFH. Only one patient had VTE, while four patients died in the hospital. The study observed a low recruitment rate but a high consent rate. Furthermore, there were no major safety concerns identified with any of the three pharmacologic prophylaxis regimens that were evaluated. NCT05237726.

Stress Ulcer Prophylaxis Versus Placebo-A Blinded Pilot Randomized Controlled Trial to Evaluate the Safety of Two Strategies in Critically Ill Infants With Congenital Heart Disease.

The routine use of stress ulcer prophylaxis (SUP) in infants with congenital heart disease (CHD) in the cardiac ICU (CICU) is controversial. We aimed to conduct a pilot study to explore the feasibility of performing a subsequent larger trial to assess the safety and efficacy of withholding SUP in this population (NCT03667703). Single-center, prospective, double-blinded, parallel group (SUP vs. placebo), pilot randomized controlled pilot trial (RCT) in infants with CHD admitted to the CICU and anticipated to require respiratory support for greater than 24 hours. Patients were randomized 1:1 (stratified by age and admission type) to receive a histamine-2 receptor antagonist or placebo until respiratory support was discontinued, up to 14 days, or transfer from the CICU, if earlier. Feasibility was defined a priori by thresholds of screening rate, consent rate, timely drug allocation, and protocol adherence. The safety outcome was the rate of clinically significant upper gastrointestinal (UGI) bleeding. We screened 1,426 patients from February 2019 to March 2022; of 132 eligible patients, we gained informed consent in 70 (53%). Two patients did not require CICU admission after obtaining consent, and the remaining 68 patients were randomized to SUP (n = 34) or placebo (n = 34). Ten patients were withdrawn early, because of a change in eligibility (n = 3) or open-label SUP use (n = 7, 10%). Study procedures were completed in 58 patients (89% protocol adherence). All feasibility criteria were met. There were no clinically significant episodes of UGI bleeding during the pilot RCT. The percentage of patients with other nonserious adverse events did not differ between groups. Withholding of SUP in infants with CHD admitted to the CICU was feasible. A larger multicenter RCT designed to confirm the safety of this intervention and its impact on incidence of UGI bleeding, gastrointestinal microbiome, and other clinical outcomes is warranted.

Level of physical activity among adolescents in Ernakulam District, Kerala: A cross-sectional study.

For children aged 5-17 years, WHO recommends moderate-to-vigorous intensity physical activity for at least 60 minutes daily which would account for 420 minutes of physical activity per week regardless of working days or holidays. With the increasing prevalence of non-communicable diseases in Kerala, this study aimed to assess the level of physical activity among high school students in Ernakulam District, Kerala. A school-based cross-sectional study was conducted among ninth and tenth standard students of two randomly selected schools in Ernakulam District. A total of 303 children were recruited for the study. Consent rate and response rate of the study were 100%. A structured questionnaire adapted from MRC-CPAQ (Children's Physical Activity Questionnaire) was used to collect the data. The study revealed that out of 303 students, 72.9% were < 15 years, 77% were males, and 59% were urban residents. More than 70% of the participants were actively involved in physical activity of moderate-to-vigorous intensity. Males, in the age group of 15 years and above, having a separate play area, and those with no siblings were found to have significantly higher levels of physical activity. The study was able to identify a positive trend for physical activity among adolescents. Town planning and building of play areas are essential to develop and retain the habit of physical activity among adolescents.