Consent Form Research Articles

Enhancing Professional Awareness of Informed Consent : Safeguarding the Rights of Patients and Practitioners.

Informed consent is a crucial communication process between doctors and patients for obtaining patients' approval before initiating medical treatment. It is derived from the legal principles of medical contracts and requires doctors to explain the treatment process to patients. Surgeons should be aware of informed consent not only to avoid unnecessary litigation risks but also to provide patients with the right to self-determination. The aim of the study is to help surgeons in Korea understand the legal doctrine on informed consent for practical application. This article reviews the legal doctrine of IC according to 4W1H-why, who, what, when, and how-with judicial cases to communicate effectively with patients in clinical settings. Regardless of seniority or rank, doctors may provide competent patients with information to protect their rights to self-determination. Informed consent should be advanced for patients to consider, discuss with significant others, and determine whether or not to undergo medical treatment. At that stage, patients need to be informed of the necessity, risks, and so on. The most common method of informed consent is an oral explanation utilizing certain forms for documentation. However, the informed consent of patients can be exempted on certain occasions. Optimal informed consent, when implemented, leads to patient-centered care, which significantly improves patient satisfaction and outcomes. Ultimately, it not only protects doctors from litigation risks but also upholds patients' autonomy.

Ultrasound Evaluation of the Optic Nerve Sheath as a Predictor of Severity and Complications

Objectives: Ultrasonography has the potential advantage of being a repeatable tool, safe at the bedside and low cost, without risks of radiation and side effects. Emerging as a tool with potential to promote the optimization of the prognosis of neurosurgical patients. Methods: 31 participants diagnosed with expansive brain injury were selected, all over 18 years of age, after signing the free consent form and clarification, the postoperative evaluation was carried out at the time of hospital discharge and 3 months after surgery on an outpatient basis. The ultrasound evaluation of the optic nerve sheaths was performed by a team member, who was blind to the clinical and radiological information and using the same GE VERSANA ACTIVE ultrasound device. Results: During the preoperative analysis of 31 patients, 41.9% were male (n=13) and 58.06% female (n=16), with a mean age of 50.64 +- 16.29. Regarding the functional analysis with KPS, it was found that 58% of patients (regardless of sex) had results >=70, equivalent to 18 patients. Regarding the diameter of the optic nerve sheath performed by ultrasound, the value of the preoperative BOD was greater than 6.1 mm, the value greater than 6.2 mm determined unfavorable prognosis in 3 months. Discussion: In the present study, the cutoff point of the BNO measurement for favorable or unfavorable prognosis was 6.1 mm, and when we correlated this variable with the analyzed KPS variable, we can observe that they correlate, mainly with outcome, getting an unfavorable result.

Vitamin D combined with whole-body vibration training for the treatment of osteo-sarcopenia: study protocol for a randomized controlled trial.

Osteo-sarcopenia (OS) has become a global public health problem and a frontier research problem, as a combination of sarcopenia (SP) and osteoporosis (OP) diseases. The clinical performances include muscle weakness, systemic bone pain, standing difficulty, even falls and fractures, etc., which seriously affect the patient's life and work. The pathological mechanism of the OS may be the abnormal metabolism which disrupts the equilibrium stability of the musculoskeletal system. Therefore, this study combined vitamin D (Vit. D) and whole-body vibration training (WBVT) to intervene in subjects of OS, aiming to evaluate the effectiveness and safety of the diagnosis and treatment protocol and to explore the efficacy mechanism. We propose a multicenter, parallel-group clinical trial to evaluate the efficacy and safety of Vit. D combined with WBVT intervention in OS. Subjects who met the inclusion or exclusion criteria and signed the informed consent form would be randomly assigned to the WBVT group, Vit. D group, or WBVT+ Vit. D group. All subjects will be treated for 1 month and followed up after 3 and 6 months. The primary outcomes are lumbar bone mineral density (BMD) and appendicular skeletal muscle mass (ASM) measured by dual-energy X-ray absorptiometry (DXA) and handgrip strength measured by grip strength meter. Secondary outcomes include serum markers of myostatin (MSTN), irisin and bone turnover markers (BTM), SARC-CalF questionnaire, 1-min test question of osteoporosis risk, patient health status (evaluated by the SF-36 health survey), physical performance measurement that includes 5-time chair stand test, 6-m walk, and the short physical performance battery (SPPB). If Vit. D combined with WBVT can well relieve OS symptoms without adverse effects, this protocol may be a new treatment strategy for OS. After therapeutic intervention, if the serum marker MSTN/irisin is significant, both have the potential to become sensitive indicators for screening OS effective drugs and treatments, which also indicates that WBVT combined with Vit. D plays a role in improving OS by regulating MSTN/irisin. Chinese Clinical Trial Registry ChiCTR2400082269 . Registered on March 26, 2024.

Reliability and Validity of Hindi Version of the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for Diagnosis of Delirium: A Cohort Study.

The confusion assessment method for the intensive care unit (CAM-ICU) is a bedside tool to diagnose delirium in critically ill patients. This study aims to determine the reliability and validity of the Hindi version of CAM-ICU against the Diagnostic and Statistical Manual (DSM), fourth edition text revision (DSM-IV-TR), and DSM, fifth edition (DSM-5) criteria for diagnosis of delirium. Seventy-five Hindi-speaking consenting patients ≥18-year-old with Richmond Agitation Sedation Scale ≥-3 and an anticipated ICU stay > 48 hours were included. Patients with known severe mental illnesses, visual/hearing loss, neurological injury, burns, drug overdose, and Glasgow Coma Scale <9 at the time of screening were excluded. After 48 hours of ICU stay and ensuring at least 2 hours of sedative interruption, within a 4-hour period, two examiners independently assessed delirium using the Hindi version of the scale and an experienced psychiatrist assessed the patients independently and applied the DSM-IV-TR and DSM-5 criteria for diagnosing delirium. Time taken for CAM-ICU assessment, inter-observer reliability, sensitivity, specificity, and positive and negative predictive values were calculated. The Cohen's κ value was 0.944 (p < 0.001). The Cronbach's α for observer 1 and observer 2 was 0.961 and 0.968, respectively. The sensitivity and negative predictive value of the tool was 100% with both DSM-IV-TR and DSM-5. The specificity was 90.2% and 92% and the positive predictive value was 82.8 and 86.2% with DSM-IV-TR and DSM-5, respectively. The Hindi version of CAM-ICU is a reliable and valid tool for the diagnosis of delirium in an ICU setting. The study was registered with the Clinical Trials Registry, India (CTRI) as per the research guidelines laid down by the Indian Council of Medical Research before enrolling the participants. (CTRI number- CTRI/2021/01/030471). The registration date was 14th January 2021. URL of registry is http://ctri.nic.in. Delirium in the ICU is often undiagnosed due to unfamiliarity, lack of understanding of symptoms, non-availability of psychiatric consultation, and validated diagnostic tools in the native language of the patient. This study aims to find the reliability and validity of the Hindi version of CAM-ICU. Salhotra R, Bose A, Srivastava S, Mohta M, Pandarinathan K, Rautela RS. Reliability and Validity of Hindi Version of the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for Diagnosis of Delirium: A Cohort Study. Indian J Crit Care Med 2024;28(10):958-962.

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.

Improving Recruitment Of Older Patients For Patient And Public Involvement And Engagement Work (PPIE): Ensuring A Representative Voice

Abstract Background Older people are under-represented in research, despite this demographic being the biggest users of healthcare resources. Service design needs to be patient-centred and therefore engaging this underserved group is crucial, albeit challenging. We describe a quality improvement project aimed at improving recruitment of patients into a local PPIE group in a perioperative geriatric service. Methods Clinicians opportunistically consent patients for the PPIE group during their perioperative geriatric clinic consultations. A baseline level of recruitment was established before implementing a series of PDSA cycles. The interventions were firstly, to adapt the paper clinic proforma making the consent section clearer, secondly to give weekly reminders to clinicians, and finally discussing PPIE with patients while they wait for their appointment. A focus group with clinicians was run using nominal group technique to explore barriers and potential solutions to recruitment. Results An average of three patients were being recruited per month from April 2022 to September 2023. Two weeks following the first intervention, no new patients were consented. Two weeks following the second intervention, this improved to two new patients. Following the third intervention, five new patients were recruited after two clinic sessions. From the focus group, the top three barriers to recruitment were forgetting, clinical responsibilities taking priority, and lack of awareness by new staff. The highest rated solution was utilising non-clinical staff to recruit patients in the waiting room. Conclusion During busy clinics, it is easy for clinicians to forget about issues not directly related to the patient in front of them. However, PPIE is vital in co-designing healthcare. There are both staff and patient-related barriers in recruiting and maintaining a PPIE group in older patients. From our project, we found a combination of passive (e.g. a tickbox proforma) and active recruitment by dedicated staff the best way to improve PPIE.

Perceptions and Expectations of Patients with Lung Cancer and Melanoma about the Telenursing Approach: A Phenomenological Study.

Telenursing could improve continuity of care in patients with cancer. This study aims to explore the expectations and perceptions of patients with lung cancer and melanoma toward telenursing. A descriptive qualitative study using a phenomenological approach was conducted on a convenience sampling of twenty patients aged 18 years or over from a Cancer Center. With the consent of patients and the relevant Ethics Committee, in-depth open-ended face-to-face interviews were conducted until data saturation. The phenomenon's essence was achieved through themes emerging from the qualitative data analysis. Patients' perceptions and expectations were related to areas explored by a general theme on the nurse-patient relationship's importance. Four themes and eleven sub-themes were focused on misconceptions about lack of use, patients' potential and fears, the home as a place of care, and the caring relationship. Fifteen patients perceived the internet as a chaotic "bubble". Despite the lack of previous use, patients consider telenursing positively as "a bridge between home and care", especially in the advanced stages of the disease. They highlighted strengths and weaknesses of telenursing, such as having "someone for you", connection, fear of psychological addiction, loss of privacy, and lack of empathy. This study was not registered.

Biobanking, digital health and privacy: the choices of 1410 volunteers and neurological patients regarding limitations on use of data and biological samples, return of results and sharing

BackgroundThe growing diffusion of artificial intelligence, data science and digital health has highlighted the role of collection of data and biological samples, thus raising legal and ethical concerns regarding its use and dissemination. Further, the expansion of biobanking, from the basic collection of frozen specimens to the virtual biobanks of specimens and associated data that exist today, has given a revolutionary potential on healthcare systems, particularly in the field of neurological diseases, due to the inaccessibility of central nervous system and the need of non-invasive investigation approaches. Informed Consent (IC) is considered mandatory in all research studies and specimen collections, and must specifically take into account the ethical respect to the individuals to whom the used biological material and data belong.MethodsWe evaluated the attitudes of patients with neurological diseases (NP) and healthy volunteers (HV) towards the donation of biological samples to a biobank for future research studies on neurological diseases, and limitations on the use of data, related to the requirements set by the General Data Protection Regulation (GDPR). The study involved a total of 1454 subjects, including 502 HVs and 952 NPs, recruited at Santa Lucia Foundation IRCCS, Rome, from 2020 to 2024.ResultsWe found that (i) almost all subjects agreed with the participation in biobanking (ii) and authorization to genetic studies (HV = 99.1%; NP = 98.3%); Regarding the return of results, (iii) we found a statistically significant difference between NP and HV, the latter preferring not to be informed of potential results (HV = 43%; NP = 11.3%; p < 0.0001); (iv) a small number limited the sharing inside European Union (EU) (HV = 4.6%; NP = 6.6%), whereas patients were more likely to refuse transfer outside EU (HV = 7.4%; NP = 10.7% p = 0.05); (v) nearly all patients agreed with the use of additional health data from EMR for research purposes (98.9%).ConclusionsConsent for the donation of material for research purposes is crucial for biobanking and biomedical research studies that use biological material of human origin. Here, we have shown that choices regarding participation in a neurological biobank can be different between HVs and NPs, even if the benefit for research and scientific progress is recognized. NP have a strong interest in being informed of possible results but limit sharing of samples, highlighting a perception of greater individual or relative benefit, while HV prefer a wide dissemination and sharing of data but not to have the return of the results, favoring a possible benefit for society and knowledge. The results underline the need to carefully manage biological material and data collected in biobanks, in compliance with the GDPR and the specific requests of donors.

Researchers experience and views on participants’ comprehension of informed consent in clinical trials in Malawi: a descriptive qualitative study

BackgroundInformed consent is the cornerstone of research ethics. One of its goals is that participants enter research with an understanding of what their participation entails. This paper is a study on how researchers understand the informed consent process. Previous studies have looked at this topic from a research participant perspective. However, few studies focus on the perspectives of the researchers. Therefore, this is an important paper that highlights an important issue (informed consent) from the perspective of those who administer it during research.MethodsIn-depth interviews were conducted with 18 researchers from 3 different research centers in Malawi working in clinical trials. The data was analyzed using open code utilizing the thematic approach to qualitative data.ResultsThis study identified that researchers have good awareness of the role of informed consent, how important it is for participants to understand the given information and ways to adjust their practice accordingly when obtaining it in order to enhance participant understanding. According to the research staff, most participants do not really understand all the concepts of the study at the initial visit, they gain more understanding during subsequent visits. It was emphasized that the best method of facilitating informed consent is reading the informed consent to the participant, thus a face-to-face conversation. Long and complex informed consent was identified as one of the barriers to participant understanding of the informed consent. Shortening the informed consent form and having additional conversation with the participants was suggested as one way of improving participant comprehension.ConclusionMost of the participants understand much of the information during subsequent visits as you keep reminding them since informed consent is an ongoing process. Existing relationship or trust between a participant and a researcher, may influence participants’ decision and misguide their understanding on the purpose of the study. Adequate time should be allocated to informed consent discussions. Shortening the informed consent forms and having additional conversations with potential participants may help improve their understanding.

Comparing NEWS2, TRISS, RTS, SI, GAP, and MGAP in predicting early and total mortality rates in trauma patients based on emergency department data set: A diagnostic study

IntroductionIn the global context, trauma remains a significant cause of mortality, particularly among individuals under 50 years old with mortality and morbidity. Timely assessment, efficient triage, and appropriate post-trauma care can help mitigate long-term mortality and morbidity risks. While the trauma and injury severity score (TRISS) is considered accurate, its complexity limits clinical utility, prompting the development of new tools like the National Early Warning Score 2 (NEWS2) and others. Thus, this study aims to evaluate the predictive abilities of NEWS2, RTS (revised trauma score), TRISS, SI (shock index), GAP (Glasgow coma score, age, and systolic blood pressure), and MGAP (mechanism of injury, Glasgow coma score, age, and systolic blood pressure) scoring systems in trauma patient care to enhance outcomes and reduce mortality and morbidity rates. MethodsThis retrospective diagnostic study included a total of 6894 trauma patients with data collected from the emergency department. Patient information, including vital signs and demographic data, was recorded on datasheets completed by ED staff. Ethical guidelines were followed, and patient consent forms were not required due to the study's retrospective nature. Scoring systems such as NEWS2, RTS, TRISS, SI, GAP, and MGAP were calculated and interpreted based on specific formulas and scoring charts. ResultsOf 6894 patients, 2.83% died during hospitalization, and 0.72% within the first 24 hours. Factors associated with mortality included age, cause of injury, duration of hospitalization, and various physiological parameters. The majority of scoring systems are reliable in predicting mortality, except for the sock index (SI), with NEWS2 demonstrating the highest sensitivity and accuracy for predicting mortality rates, while TRISS and RTS were the most specific. GAP was also the most competent predictor of overall mortality. ConclusionMost scoring systems effectively predict mortality, with TRISS and NEWS2 demonstrating high sensitivity and specificity together in forecasting in-hospital mortality. NEWS2 stands out as a precise tool for mortality prediction in the emergency department due to its simplicity and quick application. However, further research is needed to identify the most effective predictive system in trauma patients.

Keeping medical information safe and confidential: a qualitative study on perceptions of Israeli physicians

BackgroundPatients expect their information to remain confidential, and physicians have a legal and ethical obligation to keep it this way. Confidentiality is not just a legal requirement but a crucial element in establishing trust between patients and healthcare providers. Patients must feel confident that their personal and medical information is kept confidential and shared only with those who need to know. Previous studies have primarily concentrated on patients’ perceptions of medical confidentiality, data privacy, and data protection issues. However, research on the practical practices and perceptions of medical confidentiality among hospital physicians is scant, underscoring the need for a deeper understanding of this critical issue.MethodsThrough qualitative methods and as part of a large-scale study on aspects of patient dignity and responsiveness in Israel, physicians shared their views and practices on managing medical information.ResultsThe study revealed the practical challenges physicians face in upholding various aspects of data protection within hospital settings. These challenges, strategies, and deviations from data protection principles that physicians discussed are of significant practical relevance. The importance of patient consent and the practical measures for safeguarding patient information were also highlighted. While physicians acknowledged the importance of protecting patient information, they also grappled with the realities of doing so in a complex healthcare environment. In future healthcare policies, it is critical to ensure robust measures are in place to safeguard and uphold medical confidentiality. These can include specific measures to increase compliance, such as regularly monitoring compliance with confidentiality policies, producing safe and anonymous channels to voice concerns, and enforcing consequences for any breaches to ensure accountability.ConclusionsWhile protecting medical information has emerged as an important goal, it is equally crucial to strike a balance between the need to share information to advance and provide quality medical care. Physicians and policymakers must navigate this delicate balance. Additionally, organizations should strengthen compliance to enhance their monitoring and enforcement of confidentiality policies. Ineffective implementation of medical confidentiality leads to theoretical guidelines that do not translate effectively into practice.

The importance of physical therapy and occupational therapy on the quality of life and bone health in patients with osteoporosis

This study aims to evaluate. in the course of one year. the role of physical therapy and occupational therapy intervention. in association of specific drug therapy versus only drug therapy. in patients with osteoporosis. The study was carried out between April 2022 and June 2024, on 94 patients with osteoporosis. selected from the Clinical Rehabilitation Hospital in Băile Felix. All subjects signed an informed consent form 46 subjects followed drug therapy, physical therapy and occupational therapy (study group) and 46 subjects had only drug therapy (control group). The following parameters were assessed: the decrease in height. bone mineral density (BMD) - the T score and the Qualeffo test for the quality of life. Between groups analysis showed that in the study group. The post-test values of the total Qualeffo score decrease significantly and showed a smaller decrease in height compared to control group. Regarding BMD there is no significant difference between the study group compared to control group. The results of the study suggest that a specific physiotherapy can cause significant improvements both of quality of life and vertebral static disorders. As far as BMD is concerned rehabilitation has only a limiting effect of braking its decrease.

Implementing Telemedicine into Clinical Training Through Pre-recorded Video Consultations

Although the contribution of real patient encounters to medical education is well known, challenges such as a lack of suitable cases, patients not consenting to student involvement, physical space limitations that prevent every student from participating, the inability to replicate the same patient encounter, and reduced patient admissions to healthcare facilities during extraordinary periods are common obstacles that need to be addressed in clinical education. To overcome these challenges, video consultation (VC) recordings, which were made with the consent of patients having a telemedicine consultation, were collected as an archive of medical interview recordings covering a wide spectrum of pulmonary diseases. These recordings were watched by students in a classroom setting during clinical clerkships, with case discussions interspersed. This article, which also discusses the results of clinical clerkship evaluations, indicates that the use of pre-recorded VC sessions can be an effective tool for teaching good clinical practices through the ideal method of medical interviews, diagnostic approaches, evaluation of test results, communication skills with patients and their relatives, and addressing the socio-psychological aspects and social impacts of diseases. As an innovative attempt, sharing this process at an early stage of development may inspire enthusiasm for implementing this approach and open the field for further development.

The Possible Role of Progesterone Receptors in Prostate Cancer Incidences in the Iraqi Population.

Prostate cancer (PCa) is one of the leading diseases causing mortality. It comes in the third rank of common cancer types. It is considered extremely a complicated cancer type since it occurs in highly steroid-responsive and dependent tissues. Many factors are considered to play an important role in the disease progression of PCa, with some functioning at the molecular level. After applying the exclusion criteria, 200 patients who underwent proctectomy were included in this study. Following receiving patient consent, blood samples were withdrawn from patients, DNA was extracted, and precise polymerase chain reaction (PCR) amplification was conducted using specifically designed primers. The resulting amplicons were sequenced and analyzed. The progesterone receptor B (PGRB) DNA from patients showed four distinctive single-nucleotide polymorphisms (SNPs) at sites 11:101128812, 11:101128924, 11:101128949, and 11:101128986, which altered the amino acid sequences to Y>N, A>D, T>I, and C>R, respectively, compared to control. These SNPs resided in sensitive sites that either affected the control elements or promoted alterations in the protein configuration. This DNA change diminished the PGR gene function and promoted an imbalance in the encoded PGR protein structure and expression. Many factors may play a role in PCa manifestation, with steroids and progesterone initially noted as factors. Many studies have dealt with the hormonal effect on PCa; however, few have ultimately determined the molecular impact on disease progression. The presence of pathogenic SNPs in the enhancing region of the gene may impact the expression level of PGR. High or low expression levels may negatively affect gene function, which can be considered a reliable factor in prostate tumorigenesis.

Establishment and Characterization of Three Human Ocular Adnexal Sebaceous Carcinoma Cell Lines.

Ocular adnexal sebaceous carcinoma (SebCA) represents one of the most clinically problematic periocular tumors, often requiring aggressive surgical resection. The pathobiology of this tumor remains poorly understood, and few models exist that are suitable for preclinical testing. The aim of this study was to establish new cell lines to serve as models for pathobiological and drug testing. With patient consent, freshly resected tumor tissue was cultured using conditional reprogramming cell conditions. Standard techniques were used to characterize the cell lines in terms of overall growth, clonogenicity, apoptosis, and differentiation in vitro. Additional analyses including Western blotting, short tandem repeat (STR) profiling, and next-generation sequencing (NGS) were performed. Drug screening using mitomycin-C (MMC), 5-fluorouricil (5-FU), and 6-Diazo-5-oxo-L-norleucine (DON) were performed. JHH-SebCA01, JHH-SebCA02, and JHH-SebCA03 cell lines were established from two women and one man undergoing surgical resection of eyelid tumors. At passage 15, they each showed a doubling time of two to three days, and all could form colonies in anchorage-dependent conditions, but not in soft agar. The cells contained cytoplasmic vacuoles consistent with sebaceous differentiation, and adipophilin protein was present in all three lines. STR profiling confirmed that all lines were derived from their respective patients. NGS of the primary tumors and their matched cell lines identified numerous shared mutations, including alterations similar to those previously described in SebCA. Treatment with MMC or 5-FU resulted in dose-dependent growth inhibition and the induction of both apoptosis and differentiation. MYC protein was abundant in all three lines, and the glutamine metabolism inhibitor DON, previously shown to target high MYC tumors, slowed the growth of all our SebCA models. Ocular adnexal SebCA cell lines can be established using conditional reprogramming cell conditions, and our three new models are useful for testing therapies and interrogating the functional role of MYC and other possible molecular drivers. Current topical chemotherapies promote both apoptosis and differentiation in SebCA cells, and these tumors appear sensitive to inhibition or MYC-associated metabolic changes.

Abstract A110: The CaRE2 health equity center Contact Registry: Engaging underrepresented community participants in cancer research

Abstract Background: One of the most common barriers in community participant engagement in cancer research is lack of information, and at times, not being invited to participate. Contact Registries serve as a valuable tool to address this challenge, as they connect community members with cancer health research opportunities. Potential participants can choose to participate in studies they find of interest and are prime candidates for. The Florida-California Cancer Research, Education, and Engagement (CaRE2) Health Equity Center, Community Outreach Core (COC), developed a contact registry designed to engage Black/African American (B/AA) and/or Hispanic/Latinos/a (H/L) individuals in ongoing research studies conducted across our bicoastal center institutions which includes the University of Southern California Norris Comprehensive Cancer Center, the University of Florida, and the Florida Agricultural &amp; Mechanical University. The CaRE2 Contact Registry was implemented in August 2022 by the CaRE2 COC, with the primary objective to increase the number of underrepresented minority individuals participating in cancer research. Methods: Individuals are recruited into the registry utilizing both in-person and online methods. Information is provided in English and Spanish, and data is stored on REDCap. For in-person enrollment, a consent form and OPT-IN survey is completed; our online recruitment utilizes additional screening questions to ensure eligibility. The COC in Florida and Los Angeles promote the registry at local community events and through social media accounts and website (https://care2healthequitycenter.org/the-care2-contact-registry/). A $10.00 physical or electronic gift card is provided as compensation. Results: As of April 30th, 2024, 1,328 individuals have enrolled in the Registry, with participants from FL (887 = 69.5%) and CA (389 = 30.5%); with 737 participants being B/AA (57.8%), 506 H/L (39.7%), 26 non-Hispanic White (2.0%), and 6 individuals self-identified as other race/ethnicity (0.5%). We enrolled 873 female (68.5%) and 402 male (31.5%) participants. A total of 90.4% of enrollees are willing to participate in health research involving surveys, 23% in health research studies requiring saliva (24.1%), hair (23.4%), or blood (22%) sample donations. When registrants were asked for future research interest 99.9% responded Yes. Conclusion: Community participants have a high interest in engaging in research studies regardless of race/ethnicity if its via surveys, attending focus groups, and/or joining community forums. There is greater hesitancy when asked to provide biospecimens (blood, hair or saliva). Mechanisms to understand the reasons for this hesitancy, and address them, to appropriately incentivize individuals about donation of biospecimens are needed. Community efforts that connect potential enrollees to cancer studies of interest can support increased participation in cancer research among B/AA and H/L communities. Citation Format: Carolina Aristizabal, Eduardo Ibarra, Fern Webb, IIeana Guzman, Brooke Hensel, John Luque, Rosa Barahona, Diana Wilkie, Mariana C Stern, Sandra Suther, Lourdes Baezconde-Garbanati. The CaREhealth equity center Contact Registry: Engaging underrepresented community participants in cancer research [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr A110.

Abstract B059: Every day counts to cada dia cuenta: Adapting a behavioral intervention trial to accommodate Spanish language participants in a multisite study

Abstract Introduction. The number of women living with metastatic breast cancer (MBC) has doubled in the last decade. Hispanic women have lower incidence of breast cancer than non-Hispanic White women but are more likely to be diagnosed at an advanced stage. Targeted therapies can impose prolonged symptom burden resulting in significant distress and physical limitations for women with MBC. Minimizing symptom burden, while maximizing treatment response and quality of life (QoL) are the primary goals in the metastatic setting. Thus, the demand for evidence-based interventions to help improve QoL, prognosis and survivorship is critical. Every Day Counts (EDC) examines the impact of a diet and exercise intervention on QoL and explores potential mechanistic pathways (e.g., body composition, inflammation) linking lifestyle to QoL. Initially, study eligibility excluded non-English speakers. Given the burden of MBC among Latinas, including Spanish language participants was a priority; the process of achieving this goal is described herein. Methods: Participants complete surveys and physical assessments at baseline and are then randomized to the 16-week lifestyle intervention OR the attention control organizational program. Both are led by a trained coach and include a program binder and weekly text messages whereas only the intervention receives a Fitbit and cooking classes. After the16-week program, participants complete surveys and physical assessments, and the control group participants crossover to the lifestyle program. Surveys include QoL, diet, physical activity, pain, cognitive function, sleep, outcome expectancy, social support, mood, and self- efficacy. Physical assessments include a 24-hour diet recall, DEXA, 6-minute walk, sit-to-stand, handgrip, arm curl, single leg balance, and blood draw. Adapting the trial for Spanish language participants required multiple steps and was led and implemented by bilingual, bicultural staff that went beyond translation and back-translation. Material Inventory. Review participant- facing materials to inform plan for adaptation and translation. Survey Review (N=17). Identify which measures are available and validated in Spanish using Pubmed and other search engines and/or contacting instrument author(s). Intervention Review. Staff review for content relevance for Latinas, include images and recipes illustrative of Latina culture. Translation. The study used a translation/back-translation process for recruitment scripts and materials, consent form, all surveys not available in Spanish, physical assessment protocols, intervention and control materials and text messages. Translation Review. To ensure the context of translation across dialects common to the Midwest, materials were reviewed by community members (Mexico, Puerto Rico, Dominican Republic), with discrepancies resolved by staff. Discussion:: Transitioning studies to be more inclusive will increase critical access to much-needed trials that will impact disparities evident among minoritized communities. Citation Format: Diana L. Navarro Suarez, Patricia Sheean, Estefania Alonso, Sandra Contreras, Kathleen O’Connell, Margaret Tovar, Melinda Stolley. Every day counts to cada dia cuenta: Adapting a behavioral intervention trial to accommodate Spanish language participants in a multisite study [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B059.

Abstract B114: Enhancing understanding and engagement: Investigating the impact of education on clinical trial participation

Abstract Institutions: Thomas Jefferson University Department of Oncology Funded by: NIH/NCI 3P30CA056036-22S1 Background Clinical trials (CT) advance knowledge in cancer care. Access to CT may be facilitated by patient knowledge. We evaluated the impact of a tailored CT educational video intervention via a pre- and post-test survey on CT interest and enrollment. Methods Participants included persons with cancer (PwCa) as well as persons without cancer—general population (GP). A McNemar test was used to assess the differences in survey scores for patients knowledge (11 questions) and intention-to-participate in future CT (6 questions). Results 363 (GP) and 116 (PwCa) participated; 178 and 55 participants completed both pre- and post-surveys, respectively. GP: 148 (70%) men, 58 (28%) women, 2 (1%) transgender, 2 (1%) non-binary; white, non-Latinx 125 (60%), Black 60 (29%), Asian 2 (1%), Latinx 52 (25%). PwCa: 48 (47%) men, 48 (53%) women; white, non-Latinx 71 (79%), Black 8 (9%), Asian 7 (7%), Latinx 5 (6%).The mean age was 30 yrs (sd: 7 yrs) [GP] and 55 yrs (sd: 17.8 yrs) [PwCa]. PwCa scores significantly improved for “In a CT, a patient will always get the new medicine or treatment being tested” (p=0.003). GP scores significantly improved for “You can only join a CT after you have tried all other options (p=0.002)”, “CTs test whether a new medicine or treatment works (p=0.031)” and “Once I sign a consent form, I must stay in the CT until my doctor tells me I'm done (p=0.0001).” The intention to participate in CT improved significantly in PwCa (p&amp;lt;0.05). The intention to gain more information about CT from their physicians and discussing CT with family (p&amp;lt;0.05) improved significantly in GP. Conclusions The tailored educational intervention significantly impacted PwCa’s intention to participate in CT and GP’s intention to learn more about CT and to share the CT information learned. The GP group was more diverse. Ongoing research is monitoring whether PwCa participants enroll in a CT, thereby assessing the long-term impact of the educational intervention on decision-making regarding CT participation taking into account CT availability and eligibility. Citation Format: Jesutomisola Onafowokan, FNU Nikita, Iqra Siddiqui, Ana Maria Lopez. Enhancing understanding and engagement: Investigating the impact of education on clinical trial participation [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B114.

Abstract B110: A community-based educational intervention to improve colorectal cancer screening

Abstract Background: Colorectal cancer (CRC) is the 3rd leading cause of cancer death in the US. Early detection through screening increases survival and decreases mortality. Approximately 59% of eligible adults in the US are up to date on CRC screening with lower rates in minoritized communities. We report on a tailored a CRC screening educational intervention focused on improving CRC screening rates in the Black, Latinx, and Chinese immigrant communities that we serve. Methods: An educational intervention utilizing NCI’s Screen to Save CRC colorectal cancer educational materials was tailored through key contact interviews and focus groups with Black, Latinx, and Chinese immigrant communities and made available in Spanish/English/Mandarin. Invitations to participate were primarily disseminated through weekly email blasts to adults (persons age18+). A pre- and post-intervention survey was used to assess patient knowledge and intentions to screen. Persons completing the post-survey received a FIT test for CRC screening with a FIT. We used McNemar test to compare the results pre- and post-survey. Results: Of the 300 participants who completed the post-survey, 117 (39%) were male, and 183 were female (61%). 231 identified as white non-Latinx (77%), 48 (16%) Black, 3 (9%) Asians. 241 (80.3%) completed college. 186 (62%) had received CRC screening—176 (95%) by colonoscopy, 31 (17%) by fecal immunochemical test FIT prior to enrollment. 240 (80%) were eligible for FIT by age. 137 (83%) were interested in receiving FIT. Primary reasons for not pursuing FIT test included choosing to pursue a colonoscopy or having had a recent normal colonoscopy. 88 expressed interest pursuing FIT; 66 (75%) participants signed FIT consent form, and 41 (62%) completed FIT. Knowledge regarding CRC screening improved for the following questions: CRC starts in liver (p=0.0082), small intestine (p&amp;lt;0.0001) and colon and/or rectum (p=0.0027), “FIT checks the stool for fat (p&amp;lt;0.0001), tumors (p&amp;lt;0.0001) and polyps (p=0.0067),” “Risk factors for CRC are poor diet (p=0.0019), smoking/tobacco use (p=0.0148), lack of physical activity(p=0.0012),” “Lynch syndrome is a disorder that runs in families and increases my chances of developing CRC (p&amp;lt;0.0001)” and “Increasing my physical activity will not lower my chances of developing CRC (p=0.0019).” 153 (60.24%) said the education session was great and 91 (36.25%) said it was good. When asked if they would recommend this education session to family and friends, more than 80% of participants agreed. Conclusions: CRC education video helped increase patient knowledge regarding CRC, specifically about risk factors and improved knowledge regarding FIT as a CRC screening modality. Citation Format: Iqra Siddiqui, FNU Nikita, Ana Maria Lopez. A community-based educational intervention to improve colorectal cancer screening [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B110.

Factors Influencing the Participation of Shared Decision Making in Stable Coronary Artery Disease Patient: Protocol of a Mixed Methods Study.

The "paternalistic decision-making model" is no longer well suited to the modern clinical environment, and therefore, shared decision making (SDM) has emerged as a key approach. Although the benefits of SDM have been largely reported, several studies have reported low participation in SDM in coronary artery disease (CAD) patients. The theory of planned behavior (TPB) model is one of the most frequently employed theoretical frameworks for predicting human behaviors. According to the TPB, intention is influenced by attitude, subjective norm, and perceived behavioral control, while behavior is influenced by both intention and perceived behavioral control. Therefore, we propose a mixed methods study based on TPB to investigate the status of Chinese stable coronary artery disease (SCAD) patients' participation in SDM, understand their experiences of SDM, and explore the factors that influence their participation in SDM. An explanatory sequential mixed methods design will be used to explore the study aims, including a quantitative phase, a subsequent qualitative phase, and the final integration study. The quantitative study will use convenient sampling from the Affiliated Hospital of Hangzhou Normal University to conduct a cross-sectional survey (n ≥ 252). The qualitative study will be sampled using the maximum difference sampling method from the quantitative study results, and then the data will be collected through semi-structured interviews (n = 10-20). This study will use descriptive statistics and test hypotheses while considering a p-value of <0.05, which will be considered statistically significant. The study employs a mixed method approach with an explanatory sequential design, incorporating qualitative and quantitative methods to comprehensively understand the factors influencing SCAD patients' participation in SDM. Furthermore, these findings can inform the design of future intervention studies and provide healthcare providers with targeted information and communication to help SCAD patients make the most appropriate decisions. Study participants will be recruited using convenience sampling from just one single clinical setting, which may limit the findings' generalizability. This study has been approved by the Ethical Committee of the School of Nursing, Hangzhou Normal University (Approval No.: 2024013). All the participants will sign an informed consent form before participating in the survey. The corresponding results and conclusions will be disseminated in journals and conferences after the completion of the study.