Development of a sexual consent intervention for adolescents with intellectual and developmental disabilities.

BACKGROUND: Tailored sexuality education for adolescents with intellectual and developmental disabilities is a crucial, yet unmet, need as this population is particularly at risk for sexual abuse and victimisation. However, there are no evidence-based interventions to specifically address this need. This paper presents the development of an intervention framework to address equity in sexuality education and support adolescents with intellectual and developmental disabilities to understand and provide sexual consent, a foundational aspect of sexuality education and sexual health. METHODS: The Sexual Health Equity Project team used a Community-Based Participatory Research approach to develop a four-module sexual consent intervention for adolescents with intellectual and developmental disabilities. We leveraged a diverse, interdisciplinary team in a suburban Midwestern school district, and used Backward Design to create objectives and assessments which were rooted in findings from qualitative data by special education teachers. RESULTS: The resulting sexual consent intervention, Ask Me First-Choices, is comprised of four modules covering topics including definition of sexual consent; decision-making strategies and practice; communicating consent and refusal, identifying situations of consent and non-consent; and legal issues surrounding consent. Each module is divided into five components for content delivery: (1) introduction, (2) lecture, (3) supplemental activity, (4) assessment, and (5) conclusion. We detail the intervention's unique aspects, emphasising areas where we used Universal Design for Learning principles to support teachers' instruction and students' learning. CONCLUSION: Our efforts to create a sexual consent intervention directly address sexuality education equity issues. We offer commentary on our design process and decisions, as well as recommendations for future groups who want to develop sexual health interventions in similar contexts for students with intellectual and developmental disabilities. Next steps include further testing and validation of the sexual consent intervention to build the evidence-base of sexuality education for adolescents with intellectual and developmental disabilities.

Marital Conflict and Healthy Dietary Habits Among Preschoolers: A Study of the Experience of Coupled Women in Urban Mexico.

In Mexico social dynamics are changing toward less traditional arrangements. With a qualitative interview study, we explore the link between marital conflict and mothers' ability to foster healthy dietary habits. Sample consisted of 21 middle-class cohabitating mothers of preschoolers. Results suggests that marital conflict leads women to experiences of tension, ambivalence, or inaction on fostering healthy eating habits. Parents' mismatch in gender beliefs, food preferences, time orientation, and risk aversion play a role in creating disagreements. When men participate, women feel "helped" and grateful, but the forms and extent of desired participation may vary among traditional, ambivalent and non-traditional women.

The Impact of Addictions Management Following Cardiac Surgery on People Who Inject Drugs and Have Infective Endocarditis.

Background: Managing reinfection in patients who inject drugs and have undergone cardiac surgery could reduce mortality. A significant gap exists in the management of addiction in this population and it is rarely addressed during index hospitalization for surgical intervention. This study sought to determine if management of addiction changed rates of readmission for reinfection. Methods: This study was a retrospective chart review and analysis. Patients who underwent cardiac surgery for infective endocarditis due to injection drug use underwent a full chart review to determine if they received management of their addiction (addictions medicine consultation, social work consultation, medication- and/or opioid-assisted treatment, and community follow-up) following their surgical intervention. Results: A total of 41 patients were identified who met the inclusion criteria. For addictions management, 43.2% of patients received an addictions medicine consultation, 67.6% received a social work consultation, 40.5% received medication- and/or opioid-assisted treatment, and 56.8% received community follow-up. Overall mortality of these patients was 21.6%, and 56.8% of patients were readmitted with reinfection. Multivariate logistic regression showed that patients who received intervention were 1.6 times more likely to be readmitted with reinfection (odds ratio 1.65, 95% confidence interval 0.29-9.41, P = 0.5736). Female patients had a significantly higher odds of reinfection, when adjusted for gender (odds ratio 9.95, 95% confidence interval 1.42-69.72, P = 0.021). Conclusions: We demonstrated a nonstandardized approach to consultation and varying approaches to management of addiction. Patients who received intervention for addiction were more likely to be readmitted for reinfection, but this difference was not significant. Future efforts can include promotion of formalized addictions consultation services for high-risk patients.

Contexte: La prise en charge de la réinfection chez les patients qui s'injectent des drogues et ont subi une intervention chirurgicale cardiaque pourrait réduire la mortalité. Il existe des lacunes importantes dans la gestion de la dépendance dans cette population, et celle-ci est rarement abordée lors de la première hospitalisation pour l'intervention chirurgicale. Cette étude a cherché à déterminer si la gestion de la dépendance peut changer les taux de réadmission pour réinfection. Méthodologie: Cette étude consistait en une analyse rétrospective de dossiers de patients. Les patients ayant subi une intervention chirurgicale cardiaque pour une endocardite infectieuse due à l'usage de drogues injectables ont fait l'objet d'un examen complet de leur dossier afin de déterminer s'ils avaient reçu une prise en charge de leur dépendance (consultation en médecine des dépendances, consultation en travail social, traitement médicamenteux associant ou non des opioïdes et suivi communautaire) après l'intervention chirurgicale. Résultats: Au total, 41 patients répondaient aux critères d'inclusion. En ce qui concerne la gestion des dépendances, 43,2 % des patients avaient effectué une consultation en médecine des dépendances, 67,6 %, en travail social, 40,5 % avaient reçu un traitement médicamenteux associant ou non des opioïdes et 56,8 % avaient fait l'objet d'un suivi communautaire. Le taux de mortalité globale chez ces patients était de 21,6 %, et 56,8 % des patients avaient subi une réinfection ayant nécessité une nouvelle hospitalisation. Une analyse de régression logistique multivariée a montré que les patients ayant reçu une intervention avaient une probabilité 1,6 fois supérieure de subir une nouvelle hospitalisation en raison d'une réinfection (rapport de cotes de 1,65, intervalle de confiance à 95 % de 0,29 à 9,41, p = 0,5736). Après ajustement en fonction du sexe, les femmes avaient une probabilité sensiblement plus élevée de réinfection (rapport de cotes de 9,95, intervalle de confiance à 95 % de 1,42 à 69,72, p = 0,021). Conclusions: Nous avons présenté une approche non normalisée de la consultation et des diverses approches de la gestion de la dépendance. Les patients ayant reçu une intervention pour la dépendance étaient plus susceptibles de subir une nouvelle hospitalisation en raison d'une réinfection, sans que cette différence soit significative. Les efforts futurs peuvent inclure la promotion de services officiels de consultation sur les dépendances pour les patients à risque élevé.

Parental Alcohol Communication and Student Drinking: Examining Potential Differences between Underage and Legal Drinking Age Students.

BACKGROUND: We explored associations between parental alcohol communication (PCA) and student drinking behavior and protective behavioral strategies (PBS) use. METHODS: College students in the United States, who had talked about alcohol with parents, (N = 251) completed an anonymous online survey in Fall 2021. Participants reported frequency of discussing 14 alcohol-related topics with parents, past 30-day drinking behaviors, and PBS use. RESULTS: We identified two forms of PCA: general alcohol information and alcohol risk information, with alcohol risk information being more common than general alcohol information. PCA was not significantly associated with drinking behavior but was associated with two types of PBS. Specifically, general alcohol information was associated with greater use of serious harm reduction and stopping or limiting drinking strategies. Additionally, legal drinking age status moderated the associations between both forms of PCA and the use of stopping or limiting drinking strategies. In general, underage students stopping or limiting drinking strategies benefited from general alcohol information but not alcohol risk information. Legal drinking age students stopping or limiting drinking strategies benefited from alcohol risk information. CONCLUSIONS: Among these students, PCA appears to have a greater impact on PBS use rather than drinking behavior. This may reflect a shift in students' beliefs about parental authority over alcohol and parents' acceptance of alcohol use by their children.

Stigma as a local process: Stigma associated with opioid dependency in a rural-mixed Indiana county.

BACKGROUND: Because the nature and magnitude of stigmatizing views associated with opioid dependency vary by social, cultural, and structural factors, strategies to reduce public stigma towards opioid dependency should vary by context. We leverage a unique dataset with evidence of multiple stigmatizing views to understand how to target interventions to reduce stigma in a state disproportionately impacted by the opioid epidemic, with a specific focus on a rural-mixed county. METHODS: Data come from the representative Person-to-Person Health Study (2018-2020) of 2,050 Indiana residents, 224 from the rural-mixed Fayette County. Bivariate statistics and multivariate regression analyses were used to evaluate the association between Fayette County and measures of stigma (e.g., desire for social distance, prejudice, causal attributions) relative to the rest of Indiana. RESULTS: Fayette County statistically differed from the rest of Indiana on most demographic characteristics and measures of stigmatizing views. Multivariate regressions revealed that compared to the rest of Indiana, residence in Fayette County was associated with a higher desire for social distance, perceptions of unpredictability, and attributing opioid dependency to genetics and the way the person was raised. CONCLUSION: Our results contribute to growing evidence supporting the need for local approaches to address stigma. Stigma in Fayette County primarily reflects concerns about how people manage their opioid dependency. Strategies focusing on treatment and recovery potential, accompanied by extending the influence of supportive stakeholders and policies, will become important to address this stigma.

A Research-Informed Approach to Providing Behavioral Healthcare to Women with Extensive Trauma Histories.

Translating research to behavioral healthcare practice is vital for improving treatment impact but can be challenging. Current and lifetime histories of trauma need to be considered in behavioral healthcare provision as they can significantly affect an individual's treatment experience. This article provides guidance on how to utilize research findings regarding trauma prevalence and experiences of women who have substance use disorder and who are homeless or near homeless to help guide responsive healthcare and treatment in practice.

Trauma Experience Among Women Who Have Substance Use Disorders and are Homeless or Near Homeless.

Women with substance use disorders (SUDs) who are homeless or near homeless have high rates of mental health, behavioral health, and SUD treatment needs. To effectively respond to these needs, it is critical to understand the population-specific trauma experiences of these women. This descriptive study examined the extent and nature of trauma experience among women who have an SUD and are homeless or near homeless. Results (n = 851 women) indicated high rates of trauma experience. All participants (100%) reported at least one type of trauma experience in their lifetime, with the majority (75.3%) having experienced five to seven of the seven types of trauma experiences assessed. Participants reported high levels of emotional severity related to the majority of traumatic events experienced. The pervasiveness of the trauma experiences and the related emotional impact among women with SUDs who are homeless or near homeless reinforce the necessity for trauma-informed care in treatment settings.

Untold Narratives: Perceptions of Human Milk Banking and Donor Human Milk Among Ghanaian Immigrant Women Living in the United States.

BACKGROUND: Donor human milk (DHM) though primarily administered in the NICU setting is increasingly being offered in well baby nurseries to promote exclusive breastfeeding. Despite the evidence supporting the use of DHM as a preferred supplement when mother's own milk (MOM) is unavailable or insufficient, foreign-born non-Hispanic black women are less likely to use DHM. Recognizing the cultural diversity and uniqueness among foreign-born non-Hispanic black communities in the USA, this exploratory study sought to understand perceptions of DHM and human milk banking (HMB) as well as factors influencing decision-making toward DHM among Ghanaian immigrant women living in the USA. METHODS: Semi-structured interviews were conducted with 16 Ghanaian women living in the USA. Using a narrative thematic approach, interview transcripts were coded, analyzed, and organized into categories and themes. RESULTS: Findings indicate mixed sentiments toward DHM/HMB among Ghanaian immigrant women. Regarding decision-making toward DHM utilization and donation, four themes were identified: (1) women's decision-making which is informed by external influences, (2) health provider's role in promoting human milk utilization, (3) the importance of addressing barriers to human milk utilization and donation, and (4) superstition and spirituality. CONCLUSIONS: Maternal perceptions of DHM/HMB are influenced by individual-, interpersonal-, and community-level factors. It is imperative that health promotion efforts adopt multi-level approaches to addressing the disparities in DHM access and utilization as well as factors that impact milk donation in order to ensure optimum health outcomes for neonates of foreign-born non-Hispanic black populations.

An estimation of the endoscopist's musculoskeletal injury risk for right and left lateral decubitus positions during colonoscopy: a field-based ergonomic study.

BACKGROUND: Colonoscopy exposes endoscopists to awkward postures and prolonged forces, which increases their risk of musculoskeletal injury. Patient positioning has a significant impact on the ergonomics of colonoscopy. Recent trials have found the right lateral decubitus position is associated with quicker insertion, higher adenoma detection rates, and greater patient comfort compared to the left lateral decubitus position. However, this patient position is perceived as more strenuous by endoscopists. METHODS: Nineteen endoscopists were observed performing colonoscopies during a series of four-hour endoscopy clinics. Durations of each patient position (right lateral decubitus, left lateral decubitus, prone, and supine) were recorded for all observed procedures (n = 64). Endoscopist injury risk was estimated by a trained researcher for the first and last colonoscopies of the shifts (n = 34) using Rapid Upper Limb Assessment (RULA), an observational ergonomic tool that estimates risk of musculoskeletal injury by scoring postures of the upper body and factors such as muscle use, force, and load. The total RULA scores were compared with a Wilcoxon Signed-Rank test for patient position (right and left lateral decubitus) and time (first and last procedures) with significance taken at p < 0.05. Endoscopist preferences were also surveyed. RESULTS: The right lateral decubitus position was associated with significantly higher RULA scores than the left lateral decubitus position (median 5 vs. 3, p < 0.001). RULA scores were not significantly different between the first and last procedures of the shifts (median 5 vs. 5, p = 0.816). 89% of endoscopists preferred the left lateral decubitus position, primarily due to superior ergonomics and comfort. CONCLUSION: RULA scores indicate an increased risk of musculoskeletal injury in both patient positions, with greater risk in the right lateral decubitus position.

Resection of a Large Growing Mediastinal Germ Cell Tumor Using a Multidisciplinary Approach.

Mediastinal germ cell tumors (GCTs) are rare. Post-chemotherapy residual masses in patients with a nonseminomatous GCT require resection. A patient with a large mediastinal GCT involving the left subclavian artery, superior vena cava (SVC) and hilum of the right lung is presented. Despite a biochemical response to chemotherapy, the tumor enlarged on serial imaging. With guidance from medical oncology, a multidisciplinary surgical team, including cardiac anesthesia, cardiac surgery and thoracic surgery resected the tumor with a staged reconstruction of the SVC. The procedure was well tolerated and yielded clear margins. The final pathology showed a significant associated component of rhabdomyosarcoma.

"It Was Just Really Hard to Be Pregnant in a Smaller Town ": Pregnant and Parenting Teenagers' Perspectives of Social Support in Their Rural Communities.

Teenage pregnancy has a history of being a "social problem" in the United States, with there being higher rates in rural communities. Social support, a contributor to improving mental health outcomes, can significantly impact a teenager's pregnancy and parenting experience. Using House's (1981) social support framework, this study explores the teenagers' perceptions of how their rural community reacted and responded to them as pregnant and parenting teenagers. The results were formulated through the thematic analysis of semi-structured interviews (n = 26) with current and former pregnant and/or parenting teenagers. The participants reported experiencing both positive and negative social support. There were more reports of emotional support and instrumental support among the forms of positive support than there were in the other categories. Informational support was lacking. The appraisal support from community members was negative. There is a need for rural communities to develop effective social support strategies to provide positive support for pregnant and parenting teenagers.

Perceived COVID-19 vaccine attributes associated with early adoption among adults in rural Indiana.

2019 Novel coronavirus (COVID-19) vaccination rates in the United States have plateaued in specific populations, including rural areas. To improve COVID-19 vaccination rates and to encourage early vaccine uptake in future pandemics, this study aimed to examine vaccine attributes associated with early adoption. Data are from an anonymous online survey of adults using targeted Facebook pages of rural southern Indiana towns in January and February 2021 (n = 286). The diffusion of innovation theory states that the rate of adoption of a product in a specific population is explained by five perceived attributes: relative advantage, compatibility, observability, complexity and trialability. Binary logistic regression analyses were used to examine the association of Diffusion of Innovation theory attributes of the COVID-19 vaccine on early adoption. Results indicated that trialability [odds ratio (OR) = 3.307; 95% confidence interval (CI) = 1.964-5.571; P < 0.001], relative advantage (OR = 2.890; 95% CI = 1.789-4.667; P < 0.001) and compatibility (OR = 2.606; 95% CI = 1.476-4.601; P < 0.001) showed significant independent associations with early adoption. Furthermore, age and political ideology were significant moderators of complexity and relative advantage, respectfully. Health education strategies for early vaccine uptake should focus on building trust in vaccine safety, increasing short-term benefits of vaccination and promoting relatability to personal values.

Cardiovascular Outcomes in Nova Scotia During the Early Phase of the COVID-19 Pandemic.

BACKGROUND: This study sought to determine the impact of the COVID-19 pandemic response to healthcare delivery on outcomes in patients with cardiovascular disease. METHODS: This is a population-based cohort study performed in the province of Nova Scotia, Canada (population 979,499), between the pre-COVID (March 1, 2017-March 16, 2020) and in-COVID (March 17, 2020-December 31, 2020) periods. Adult patients (age ≥ 18 years) with new-onset or existing cardiovascular disease were included for comparison between periods. The main outcome measures included the following: cardiovascular emergency department visits or hospitalizations, mortality, and out-of-hospital cardiac arrest. RESULTS: In the first month of the in-COVID period, emergency department visits (n = 51,750) for cardiac symptoms decreased by 20.8% (95% confidence interval [CI] 14.0%-27.0%, P < 0.001). Cardiovascular hospitalizations (n = 20,609) declined by 48.1% (95% CI 40.4% to 54.9%, P < 0.001). The in-hospital mortality rate increased in patients with cardiovascular admissions in secondary care institutions by 55.1% (95% CI 10.1%-118%, P = 0.013). A decline of 20.4%-44.0% occurred in cardiovascular surgical/interventional procedures. The number of out-of-hospital cardiac arrests (n = 5528) increased from a monthly mean of 115 ± 15 to 136 ± 14, beginning in May 2020. Mortality for ambulatory patients awaiting cardiac intervention (n = 14,083) increased from 0.16% (n = 12,501) to 2.49% (n = 361) in the in-COVID period (P < 0.0001). CONCLUSIONS: This study demonstrates increased cardiovascular morbidity and mortality during restrictions maintained during the COVID-19 period, in an area with a low burden of COVID-19. As the healthcare system recovers or enters subsequent waves of COVID-19, these findings should inform communication to the public regarding cardiovascular symptoms, and policy for delivery of cardiovascular care.

CONTEXTE: Cette étude visait à déterminer les répercussions de la réponse à la pandémie de COVID-19 sur la prestation des soins de santé et son incidence sur les résultats obtenus par les patients atteints d'une maladie cardiovasculaire. MÉTHODOLOGIE: Il s'agit d'une étude de cohorte représentative de la population réalisée dans la province de la Nouvelle-Écosse, au Canada (population de 979 499 habitants), entre la période précédant le début de la pandémie de COVID-19 (du 1er mars 2017 au 16 mars 2020) et la période de pandémie (du 17 mars 2020 au 31 décembre 2020). Des patients adultes (âge ≥ 18 ans) atteints d'une maladie cardiovasculaire préexistante ou d'apparition récente ont été inclus pour la comparaison entre les périodes. Les principaux paramètres d'évaluation comprenaient les visites ou hospitalisations dans un service d'urgences cardiovasculaires, la mortalité et l'arrêt cardiaque en milieu extrahospitalier. RÉSULTATS: Au cours du premier mois de la période de pandémie, les visites aux services des urgences (n = 51 750) pour des symptômes cardiaques ont diminué de 20,8 % (intervalle de confiance [IC] à 95 % : 14,0 % ­ 27,0 %, p < 0,001). Les hospitalisations en raison d'un événement cardiovasculaire (n = 20 609) ont décliné de 48,1 % (IC à 95 % : 40,4 % ­ 54,9 %, p < 0,001). Le taux de mortalité hospitalière parmi les patients admis dans des établissements de soins secondaires a augmenté de 55,1 % (IC à 95 % : 10,1 % ­ 118 %, p = 0,013). Une baisse de 20,4 à 44,0 % du nombre d'interventions chirurgicales ou interventionnelles visant à prendre en charge un événement cardiovasculaire a également été enregistrée. Le nombre d'arrêts cardiaques survenus en milieu extrahospitalier (n = 5 528) est passé d'une moyenne mensuelle de 115 ± 15 à 136 ± 14, à compter de mai 2020. La mortalité des patients ambulatoires en attente d'une intervention cardiaque (n = 14 083) a augmenté, passant de 0,16 % (n = 12 501) à 2,49 % (n = 361) pendant la période de pandémie (p < 0,0001). CONCLUSIONS: Cette étude révèle une augmentation de la morbidité et de la mortalité cardiovasculaires durant le maintien des restrictions liées à la COVID-19 dans une région où le fardeau associé à cette maladie est faible. À mesure que le système de santé se rétablit ou affronte les vagues subséquentes de COVID-19, ces résultats devraient éclairer les communications au public concernant les symptômes cardiovasculaires et orienter la politique de prestation de soins cardiovasculaires.

Optimizing cecal views during colonoscopy using patient position change.

BACKGROUND: Patient positioning has been found to be a simple technique to improve luminal distention and visualization during colonoscopy. This study examined which position provided the cleanest image of the cecum using the Boston Bowel Prep Scale (BBPS) and the best view of the cecum overall as ranked by blinded assessors. METHODS: A sample of 90 sets of cecal images were obtained from patients undergoing a non-urgent colonoscopy. Each set included cecal images of patients while lying in three positions-right lateral decubitus, left lateral decubitus, and supine. Two authors reviewed these sets of images and excluded those that were unclear. A third author, blinded to the position, selected the final 33 sets of images. Two experienced endoscopists completed a blinded survey of each image set. They used the BBPS to assess and score each image as the primary outcome measure. The endoscopists also ranked each image set in terms of the best overall view of the cecum. Data were collected using Qualtrics software. Nonparametric tests were used to analyze the data using SPSS software (v.25). A p-value of ≤ 0.05 was considered significant. RESULTS: The BBPS showed a significant difference between patient positions when tested by Kruskal-Wallis. Subsequent Mann Whitney U tests indicated that the right lateral decubitus position was ranked higher than left lateral decubitus or supine positions. There was no significant difference in the left and supine positions. Cohen's Kappa suggested moderate agreement between raters. The raters also favored the right lateral position over the other positions when assessing overall image preference displaying the cecum. CONCLUSION: These results indicate that positioning patients in the right lateral decubitus position provides the best view of the cecum during colonoscopy.

Differential Lysyl oxidase like 1 expression in pseudoexfoliation glaucoma is orchestrated via DNA methylation.

Pseudoexfoliation syndrome (PXF) is the most common cause of secondary open angle glaucoma worldwide. Single nucleotide polymorphisms (SNPs) in the gene Lysyl oxidase like 1 (LOXL1) are strongly associated with the development of pseudoexfoliation glaucoma (PXFG). However, these SNPs are also present in 50-80% of the general population, suggestive of other factors being involved in the pathogenesis of PXFG. In this study, we aimed to investigate the influence of epigenetic regulation, specifically DNA methylation, on LOXL1 expression in PXFG using human tenons fibroblasts (HTFs), aqueous humour and serum samples from donors with and without PXFG. LOXL1 expression in HTFs was measured by qPCR and Western Blotting and LOXL1 concentration in aqueous humour was determined by ELISA. Global DNA methylation levels were quantified using an ELISA for 5-methylcytosine. MeDIP assays assessed the methylation status of the LOXL1 promoter region. Expression of methylation-associated enzymes (DNMT1, DNMT3a and MeCP2) were determined by qPCR and inhibited by 0.3 µM 5-azacytidine (5-aza). Results showed that LOXL1 expression was significantly decreased in PXFG HTFs compared with Control HTFs at gene (Fold change 0.37 ± 0.05, P < 0.01) level and showed a decrease, when measured at the protein level (Fold change 0.65 ± 0.42, P = 0.22), however this was not found to be significant. LOXL1 concentration was increased in the aqueous of PXFG patients compared with Controls (2.76 ± 0.78 vs. 1.79 ± 0.33 ng/ml, P < 0.01). Increased global methylation (56.07% ± 4.87% vs. 32.39% ± 4.29%, P < 0.01) was observed in PXFG HTFs compared with Control HTFs, as was expression of methylation-associated enzymes (DNMT1 1.58 ± 0.30, P < 0.05, DNMT3a 1.89 ± 0.24, P < 0.05, MeCP2 1.63 ± 0.30, P < 0.01). Methylation-associated enzymes were also increased when measured at protein level (DNMT1 5.70 ± 2.64, P = 0.04, DNMT3a 1.79 ± 1.55, P = 0.42, MeCP2 1.64 ± 1.33, P = 0.45). LOXL1 promoter methylation was increased in patients with PXFG compared to Control patients in both blood (3.98 ± 2.24, 2.10 ± 1.29, P < 0.05) and HTF cells (37.31 ± 22.0, 8.66 ± 10.40, P < 0.01). Treatment of PXFG HTFs with in 5-azacytidine increased LOXL1 expression when compared with untreated PXFG HTFs (Fold change 2.26 ± 0.67, P < 0.05). These data demonstrate that LOXL1 expression is altered in PXFG via DNA methylation and that reversal of these epigenetic changes may represent future potential therapeutic targets in the management of PXFG.

Evaluation of the Content Validity and Cross-Cultural Validity of the Study Participant Feedback Questionnaire (SPFQ).

OBJECTIVES: The Study Participant Feedback Questionnaire (SPFQ) is a patient-completed tool designed to assess patient experiences and satisfaction with aspects associated with being involved in a clinical trial. Originally developed in oncology and among English-speaking participants, the aim of the current study was to evaluate the content and cross-cultural validity of the SPFQ in other indications and non-English-speaking countries. METHODS: Semi-structured qualitative telephone interviews were conducted with 80 participants across eight non-English-speaking countries (in Europe, South America and Asia) who had received an investigational medicinal product as part of a clinical trial in the past three years. Interviews comprised concept elicitation to identify concepts of importance to participants' trial experiences, and cognitive debriefing to assess understanding and perceived importance of SPFQ instructions, items and response options. RESULTS: Concept elicitation findings supported the content validity of the SPFQ. During cognitive debriefing, SPFQ instructions and the majority of items were well understood by participants. Participants generally considered the SPFQ items important to their clinical trial experience, albeit a handful of items assessed concepts that had not been experienced by trial participants or were redundant with other SPFQ items. The instructions, response options and recall period of the SPFQ were generally well understood. No country-level differences in understanding or importance were apparent. CONCLUSION: Study findings provide evidence for the content and cross-cultural validity of the SPFQ and support implementation of the SPFQ as a means of obtaining participant feedback across global development programmes in a variety of indications.

Amplifying the Voice of the Patient in Clinical Research: Development of Toolkits for Use in Designing and Conducting Patient-Centered Clinical Studies.

Incorporating patient perspectives into clinical studies is recognized as important to the development of high-quality, safe, and effective fit-for-patient medicines. However, no widely accepted methodology to help design more patient-centered studies has been established systematically. TransCelerate Biopharma Inc., a non-profit organization promoting collaboration across biopharmaceutical companies, organized a Patient Experience (PE) Initiative to create tools to intentionally include the patient perspective into the design and implementation of clinical studies. The resulting tools include the Patient Protocol Engagement Toolkit (P-PET), to engage patients early in protocol development, and the Study Participant Feedback Questionnaire (SPFQ), to assess patient experiences during clinical studies. To develop these toolkits, TransCelerate conducted a literature review and identified aspects of clinical studies that patients find either valuable or burdensome, or that affect participation, adherence, and engagement in a clinical study. The concepts identified were refined through elicitation of feedback from patient advisors, clinical study site advisors, and subject matter experts from member companies (MCs) of TransCelerate. This feedback was considered in identifying gaps, defining scientific methodology to understand how to evaluate patients' needs, and developing and refining the P-PET and the SPFQ. As part of the development process, descriptions/drafts of the tools were shared with patients, clinical site advisory groups, MCs, and the US Food and Drug Administration, and then revised. MCs simulated use of the tools, and feedback was incorporated into the final versions of the P-PET and SPFQ prior to public release. The P-PET and SPFQ are available free on the TransCelerate website.

A randomized controlled trial comparing right and left lateral decubitus starting position on outcomes in colonoscopy.

BACKGROUND: Patient positioning in colonoscopy has been proposed as a simple and inexpensive technique to increase luminal distention and improve navigation through the large bowel. We sought to determine if the right lateral (RL) starting position compared to the standard left lateral (LL) starting position could improve outcomes in colonoscopy. METHODS: We conducted a randomized controlled trial of 185 patients who were undergoing an elective colonoscopy. Patients were randomized to either a right lateral decubitus starting position or a left lateral decubitus starting position and the primary outcome measure was cecal intubation time. Secondary outcome measures included cecal intubation rate, patient discomfort, and sedation dosage. All colonoscopists who had successfully completed a colonoscopy skills improvement course were included in the trial. A sample size was calculated prior to the start of the study and outcomes were analyzed using univariate and multiple regression analyses. RESULTS: A total of 94 patients were randomized to RL starting position and 91 patients were randomized to LL starting position. No difference was found in time to cecal intubation comparing the RL starting position (542.6 s, SD 360.7 s) to LL starting position (497.85 s, SD 288.3 s) (p = 0.354). Variables associated with prolonged cecal intubation time included female gender, General Surgery specialty, less than 5 years of endoscopist experience, a high patient discomfort score, amount of water used, and number of position changes required to reach the cecum. There was no difference in any of the secondary outcome measures aside from the amount of midazolam used, with more midazolam used for patients starting in the right lateral decubitus position. CONCLUSION: This study failed to show an association between cecal intubation time and patient position comparing right and left lateral starting position.