Clinical Research Studies Research Articles

Focus group interviews as part of a clinical research immersion experience

Background Research is an essential component of the dental profession and should be integrated into dental education and training curricula. Opportunities to participate in clinical research studies can enrich the learning experience of those involved. Methods This paper reports a new educational method utilized to enhance the experiences of novice members of a research study team in conducting Focus Group Interviews (FGIs) as part of a double-blind clinical trial exploring an oral probiotic intervention. Study team members participated in a series of in-person FGIs conducted at the beginning and toward the end of a University-based clinical trial, which took place from October 2021 to October 2022. Results Study team members consisting of faculty, staff, and pre-doctoral dental students help plan and conduct interviews, curate, and qualitatively analyze the data. Study team members acquired experience with regard to interpersonal communication skills, organization, research subject communication, the application of human subject protection, FGI methodology, data analysis, developing presentations, and preparing scientific data presentation and publications. Conclusion Exposing dental faculty and students to clinical research studies in university settings can offer opportunities for experiential, multidimensional learning and the development of new research knowledge and skills.

The effects of garetosmab in people with fibrodysplasia ossificans progressiva (FOP): a plain language summary of the LUMINA-1 study

What is this summary about? This is a plain language summary of a clinical research study called LUMINA-1. This study investigated a medicine called garetosmab in adults with fibrodysplasia ossificans progressiva, or FOP. FOP is a very rare disease that causes new bone to form in places where it does not usually develop (also known as heterotopic ossification). In FOP, when bone is formed in areas it is not supposed to, it results in mature heterotopic bone. The build-up of new bone makes it difficult for people with FOP to move, which means they often require the use of a wheelchair or other mobility aid. People with FOP who took part in the study were experiencing bone formation in areas where new bone should not form, flare-ups (episodes of localized swelling, pain, and/or warmth), and worsening joint movement. What were the results? People with FOP were given garetosmab or placebo every 4 weeks as a liquid infusion through a vein for 28 weeks. After 28 weeks, those who were receiving placebo were switched to garetosmab and treated for 28 weeks. This part was known as the open-label portion of the trial, which is when all people received garetosmab treatment. Treatment with garetosmab did not change the mature heterotopic bone in people with FOP, but it did stop new bone lesions from forming in areas where they should not. Treatment with garetosmab also reduced the number of flare-ups. During the trial, common side effects were nosebleeds, loss of eyebrows or eyelashes, and skin and soft tissue infections. Five people died during the open-label portion of the trial, when all were on garetosmab. Their deaths appeared consistent with the known causes of death and life expectancy of people with FOP who were of a similar age and severity of disease. There was no clear pattern that linked the deaths with how garetosmab works. However, a causal relationship between deaths and garetosmab could not be ruled out. What do the results of the study mean? The LUMINA-1 study showed that in people with FOP, garetosmab stopped new heterotopic bone from developing in areas that it should not and also reduced flare-ups. This shows that garetosmab may be a useful treatment for people with FOP. More testing is needed to better understand the benefits and risks of garetosmab. Clinical Trial Registration: NCT03188666 ( ClinicalTrials.gov ) (LUMINA-1)

National Estimates of the Participation of Patients With Cancer in Clinical Research Studies Based on Commission on Cancer Accreditation Data.

National estimates of cancer clinical trial participation are nearly two decades old and have focused solely on enrollment to treatment trials, which does not reflect the willingness of patients to contribute to other elements of clinical research. We determined inclusive, contemporary estimates of clinical trial participation for adults with cancer using a national sample of data from the Commission on Cancer (CoC). The data were obtained from accreditation information submitted by the 1,200 CoC programs, which represent more than 70% of all cancer cases diagnosed in the United States each year. Deidentified, institution-level aggregate counts of annual enrollment to treatment, biorepository, diagnostic, economic, genetic, prevention, quality-of-life (QOL), and registry studies were examined. Overall, study-type estimates for the period 2013-2017 were estimated. Multiple imputation by chained equations was used to account for missing data, with summary estimates calculated separately by type of program (eg, National Cancer Institute [NCI]-designated cancer centers) and pooled. The overall estimated patient participation rate to cancer treatment trials was 7.1%. Patients with cancer participated in a wide variety of other studies, including biorepository (12.9%), registry (7.3%), genetic (3.6%), QOL (2.8%), diagnostic (2.5%), and economic (2.4%) studies. Treatment trial enrollment was 21.6% at NCI-designated comprehensive cancer centers, 5.4% at academic (non-NCI-designated) comprehensive cancer programs, 5.7% at integrated network cancer programs, and 4.1% at community programs. One in five patients (21.9%) participated in one or more cancer clinical research studies. In a first-time use of national accreditation information from the CoC, enrollment to cancer treatment trials was 7.1%, higher than historical estimates of <5%. Patients participated in a diverse set of other study types. Contributions of adult patients with cancer to clinical research is more common than previously understood.

Anlotinib for Metastatic Progressed Pheochromocytoma and Paraganglioma: A Retrospective Study of Real-world Data

Abstract Introduction Pheochromocytomas (PCC) and paragangliomas (PGL) (collectively PPGL) are a type of rare hypervascular neuroendocrine tumors; however, their therapy faces big challenging. This study aimed to determine the efficacy and safety of the multi-tyrosine kinase inhibitor anlotinib for the treatment of locally advanced or metastatic (LA/M) PPGL. Methods A total of 37 eligible patients with unresectable or progressive LA/M PPGL were enrolled. Of them, 27 patients received anlotinib alone (n = 19) or in combination (n = 8) with radionuclide therapies, including peptide receptor radionuclide therapy (PRRT) and iodine 131 metaiodobenzylguanidine (131I-MIBG). The primary endpoints included objective response rate (ORR), defined as partial response (PR) or complete response (CR), and disease-control rate, defined as PR, CR, or SD (stable disease). The secondary endpoints were progression-free survival (PFS), duration of response (DOR), and drug safety. Results For all 27 patients’ efficacy evaluation, the ORR was 44.44% (95% CI: 24.4% –64.5%) and disease-control rate was 96.29% (95% CI: 88.7% – 100%). Twelve cases (44.44%) achieved PR, 14 (51.85%) SD. The median PFS was 25.2 months (95% CI: 17.2 months – not reached). PFS was shorter in anlotinib monotherapy group than in anlotinib combination with radionuclide therapy (P = 0.2). There were no serious treatment-related AEs. Conclusion Anlotinib monotherapy or in combination with radionuclide therapies shows promising efficacy and safety for the treatment of LA/M PCC and PGL. Multi-tyrosine kinase inhibitors might represent a novel therapeutic strategy for patients with PPGL; however, large-scale prospective randomized, blinded, controlled clinical research studies are required.

Using digital tools in clinical, health and social care research: a mixed-methods study of UK stakeholders

ObjectiveThe COVID-19 pandemic accelerated changes to clinical research methodology, with clinical studies being carried out via online/remote means. This mixed-methods study aimed to identify which digital tools are currently used...

Using visual storytelling to share aggregate findings with families participating in clinical genomics research

PurposeSharing aggregate results with research participants is a widely-agreed upon ethical obligation, yet there is little research on communicating study results to diverse populations enrolled in genomics research. This paper describes the co-creation of a visual narrative to explain research findings to families enrolled in a clinical genomics research study. MethodsThe design process involved researchers, clinicians, study participants, a physician-illustrator, and a health communications expert. Drawing on themes identified in interviews with participating families, the team developed a story and comic about a fictional family participating in genomic research in the hopes of finding an explanation for their child’s condition. ResultsDesign adjustments to improve the clarity and relatability of the story and accompanying images were prompted by feedback from study participants, who showed a high degree of interest in and support for the project. Spanish and English versions of the final comic book were distributed to study participants and feedback received was positive. ConclusionOur project highlights the feasibility of using visual storytelling to convey genomic research findings to socioeconomically diverse participants. A participatory design process enhances the relevance and relatability of results sharing materials and demonstrates respect for those who contribute to clinical genomics research.

529 Implementation of a Clinical Research Feasibility Program at an Academic Medical Center

OBJECTIVES/GOALS: The objectives are 1) to describe the creation and implementation of a Clinical Research Feasibility Program at the University of Miami Miller School of Medicine (UMMSOM), and 2) to share early findings demonstrating its effectiveness in improving research operations which may be helpful for other academic medical centers. METHODS/STUDY POPULATION: Many clinical trials are closed prematurely because of low accrual or not being able to meet the target enrollment. The Miami CTSI and UMMSOM Executive Dean for Research office collaborated to establish the Research Feasibility Committee (RFC) focusing on clinical trial selection with upfront feasibility and recruitment planning. Program implementation included: 1) selecting faculty with successful clinical trial track records as committee members; 2) developing processes, tools, and governance; 3) feasibility pilot testing; and 4) feasibility program roll out and refinement. The feasibility review process starts with the PI/Designee completing a REDCap study intake form, followed by an administrative review to ensure completeness of the form. The RFC chair assigns reviewers for the studies. RESULTS/ANTICIPATED RESULTS: The RFC went live on September 1, 2022 reviewing industry sponsor clinical research studies. The RFC conducts a systematic feasibility assessment of the study protocol, operational requirements, enrollment barriers, institutional resources, and study budget (if available) for all applicable research studies prior to IRB submission and contract negotiation at the UMMSOM. To date, the RFC has received over 270 submissions. Based on feedback from users, the committee has made changes to improve the comprehension of questions and added questions to ensure capturing of critical information to assess study feasibility. Initial metrics suggest simply implementing the review process has decreased the number of clinical trial submissions: average number of studies per quarter was 41 pre-RFC vs 24 post RFC. DISCUSSION/SIGNIFICANCE: The development and implementation of the RFC involved many stakeholders from the research enterprise. Clear and frequent communication to the research community was a key factor in the program’s success. The next phase is assessing the impact of the RFC, such as preserving vital resources for trials more likely to be successful.

131 Investing in Education: Design and evaluation of an innovative clinical research coordinator New Hire Education Program to strengthen clinical and translational research

OBJECTIVES/GOALS: The overarching goal of the Mayo Clinic in Florida Clinical Research New Hire Training Programis to create a standardized work force development model that ensures all new research coordinators receive the same high-quality training and can perform their role. METHODS/STUDY POPULATION: Mayo Clinic implemented a comprehensive six-week in-class training program to teach research coordinators how to conduct clinical research studies and trials. A multi-disciplinary team with expertise in education, operations, study coordination, and human resources assisted in development. The program approaches education through the lens of application. Staff start on designated hire dates and have an assigned trainer, allowing them to complete the program in cohorts and build connections with one another. During the program, they complete assignments, checkpoints, and shadow within their units. At the conclusion, they take a one-on-one assessment with a trainer to confirm they can work independently. If a learner cannot pass, the trainer and supervisor implement a learning plan targeting their needs. RESULTS/ANTICIPATED RESULTS: The program has had 110 graduates since its April 2022 inception, with a steady improvement in learner satisfaction scores. Based on the question “My site’s new hire education program was good,” with 5 being strongly agree and 1 being strongly disagree, learners rate the current iteration as 4.38. The program has a positive correlation with retention and favorable quality reviews. 23.8% of new coordinators hired from April of 2021 to March of 2022 left within the first year. From April 2022 to September 2023, the first-year turnover rate fell to 14.55%. Additionally, 43% of quality reviews completed for graduates required no follow-up, compared to 35% of staff hired before implementation of the program. Only 5% of reviews for graduates required urgent follow-up, compared to 15% of those completed for existing staff. DISCUSSION/SIGNIFICANCE: Research Coordinators who complete the training program report a higher confidence level and demonstrate they can perform their role. The effects of our program have been so pronounced that the curriculum is being translated within Clinical Research across all of Mayo Clinic and our Florida site is researching ways to market it outside of Mayo Clinic.

The importance of individual beliefs in assessing treatment efficacy.

In recent years, there has been debate about the effectiveness of treatments from different fields, such as neurostimulation, neurofeedback, brain training, and pharmacotherapy. This debate has been fuelled by contradictory and nuanced experimental findings. Notably, the effectiveness of a given treatment is commonly evaluated by comparing the effect of the active treatment versus the placebo on human health and/or behaviour. However, this approach neglects the individual's subjective experience of the type of treatment she or he received in establishing treatment efficacy. Here, we show that individual differences in subjective treatment - the thought of receiving the active or placebo condition during an experiment - can explain variability in outcomes better than the actual treatment. We analysed four independent datasets (N = 387 participants), including clinical patients and healthy adults from different age groups who were exposed to different neurostimulation treatments (transcranial magnetic stimulation: Studies 1 and 2; transcranial direct current stimulation: Studies 3 and 4). Our findings show that the inclusion of subjective treatment can provide a better model fit either alone or in interaction with objective treatment (defined as the condition to which participants are assigned in the experiment). These results demonstrate the significant contribution of subjective experience in explaining the variability of clinical, cognitive, and behavioural outcomes. We advocate for existing and future studies in clinical and non-clinical research to start accounting for participants' subjective beliefs and their interplay with objective treatment when assessing the efficacy of treatments. This approach will be crucial in providing a more accurate estimation of the treatment effect and its source, allowing the development of effective and reproducible interventions.

A study protocol for live and deceased donor uterus transplantation as a treatment for women with uterine factor infertility.

Uterus transplantation (UTx) is an emerging treatment option for women with uterine factor infertility (UFI) or the absence of a functional uterus. This is the study protocol for the first human UTx clinical trial in Australia. This protocol outlines the approved training program used to plan, diagnose, screen, and treat patients who may be eligible for UTx using living and deceased donors. This multi-site clinical research study includes three tertiary hospital sites within New South Wales (NSW), Australia - Prince of Wales, Royal Hospital for Women and Westmead Hospitals. Our UTx protocol is based on that used by our collaborative partner, the inaugural UTx team in Gothenburg, Sweden. The Swedish UTx team provides ongoing preceptorship for the Australian UTx team. Ethics approval for six UTx procedures using living or deceased donors (Western Sydney Local Health District Human Research Ethics Committee: 2019/ETH138038) was granted in 2020. Results from surgeries and live births will be published. Data will be prospectively entered into the registry of the International Society of Uterus Transplantation (ISUTx), a sub-section of The Transplantation Society (TTS). ACTRN12622000917730. A multidisciplinary research team has been formed between three tertiary hospitals in Sydney - The Royal Hospital for Women, Prince of Wales and Westmead Hospitals; and with the Swedish UTx, University of Gothenburg. The Swedish team pioneered animal and human UTx studies since 1998, including publishing the first live birth after UTx. (1) This Australian trial commenced in January 2023. Uterus transplantation gives women with UFI the opportunity to be gestational and genetic mothers. It is a complex procedure for both the donor and recipient, with medical and surgical risks. An extensive multidisciplinary approach is required to optimise patient safety and graft outcomes. This protocol outlines our Australian UTx team strategy for screening, recruitment, surgical approach, and clinical management of UTx recipients and donors.

Morphological and Functional Correlations in Acute Central Serous Chorioretinopathy.

We evaluate morphological and functional correlations in patients with acute central serous chorioretinopathy (CSC). A prospective study was conducted on 50 patients with an acute CSC episode lasting less than 3months. At baseline, assessments included optical coherence tomography (OCT), best-corrected visual acuity (BCVA), contrast sensitivity (CS), microperimetry (MP), and multifocal electroretinography (mfERG). A correlation analysis between OCT morphological parameters (maximal subretinal fluid height (SRF), central retinal thickness (CRT), and macular volume (MV)) and functional parameters was conducted on the affected eye for each patient. Among the morphological parameters, SRF showed the strongest correlations with functional parameters (r absolute value range = 0.10-0.70). Weak correlations were observed between BCVA and morphological parameters (r absolute value range = 0.14-0.26). Average retinal sensitivity (MP-A) was the functional parameter displaying the most robust negative correlation with morphological parameters (r absolute value range = 0.61-0.70). In contrast, average contrast sensitivity (CS-A) and mfERG average amplitude density in the first (mfERG-A1) and second (mfERG-A2) ring showed weak to moderate (r absolute value range = 0.35-0.56) yet statistically significantly nonzero correlations. SRF and CRT could serve as the most representative morphological proxies for visual function deficit in acute CSC patients. Retinal sensitivity, as measured by MP, may be superior to BCVA in clinical research studies or when an in-depth visual function evaluation is needed.

O197: Quality Assessment of Human Kidneys by Ex-vivo Normothermic Machine Perfusion prior to Transplantation

Abstract Introduction Ex-vivo normothermic machine perfusion (NMP) is a technique of preservation that can be used to assess the quality and suitability of a kidney for transplantation. This may prevent the unnecessary discard and increase the number of transplanted kidneys. Methods A total of 22 kidneys declined for transplant by all UK transplant centres, were assessed over a three-year period across three centres in the UK. Prior to NMP, most kidneys were declined due to poor quality cold flushing at retrieval. All kidneys were assessed during 1h of NMP. A quality assessment score (QAS) based on the appearance, blood flow and urine output was applied to each kidney. Scores ranged from 1 (best) to 5 (worst). Results Sixteen kidneys (72%) had a QAS of 1 to 3 and were transplanted into matched recipients. One patient died with a non-functioning kidney 12 days post-transplant due to a cardiac arrest. Six recipients (37.5%) had delayed graft function. The mean serum creatinine levels and estimated glomerular filtration rate at 3 months was 154±74µmol/L and 45±15mL/min/1.73m2, respectively. Graft and patient survival at 12 months were 94%. Of the 6 non-transplanted kidneys, 3 were deemed unsuitable after assessment during NMP, 1 was not transplanted due to logistical reasons and a prolonged cold ischaemic time, and the remaining 2 due to chronic degenerative changes assessed by histology scores. Conclusion This clinical research study demonstrated the ability to use NMP technology to successfully increase the number of transplants by assessing kidneys that would otherwise be discarded.

Biologic Therapy in Pediatric Chronic Rhinosinusitis: A Systematic Review.

Provide clinicians with current evidence for biologic therapy in children with chronic rhinosinusitis with nasal polyposis (CRSwNP). PubMed, MEDLINE, Cochrane, and clinical trial registries. Key search terms related to biologic therapy in pediatric CRSwNP were identified via a structured query of current medical literature and clinical trial databases. There is a dearth of active clinical trials and research studies for biologics targeting pediatric CRSwNP. There is an ongoing compassionate-use clinical trial involving Dupilumab for children with nasal polyps as well as only 1 published work specifically focused on Dupilumab for pediatric CRSwNP in the setting of aspirin-exacerbated respiratory disease. For children with atopic dermatitis, asthma, and chronic idiopathic urticaria, biologic therapies such as Omalizumab, Dupilumab, and Mepolizumab have gained Food and Drug Administration approval. The role of biologic therapy in pediatric CRSwNP demonstrates significant promise in the comprehensive management of the unified airway. Additional Phase III trials are necessary to broaden clinical indications for children with comorbid conditions and complex sinonasal disease.

Impacts of optimal control strategies on the HBV and COVID-19 co-epidemic spreading dynamics

Different cross-sectional and clinical research studies investigated that chronic HBV infected individuals’ co-epidemic with COVID-19 infection will have more complicated liver infection than HBV infected individuals in the absence of COVID-19 infection. The main objective of this study is to investigate the optimal impacts of four time dependent control strategies on the HBV and COVID-19 co-epidemic transmission using compartmental modeling approach. The qualitative analyses of the model investigated the model solutions non-negativity and boundedness, calculated all the models effective reproduction numbers by applying the next generation operator approach, computed all the models disease-free equilibrium point (s) and endemic equilibrium point (s) and proved their local stability, shown the phenomenon of backward bifurcation by applying the Center Manifold criteria. By applied the Pontryagin’s Maximum principle, the study re-formulated and analyzed the co-epidemic model optimal control problem by incorporating four time dependent controlling variables. The study also carried out numerical simulations to verify the model qualitative results and to investigate the optimal impacts of the proposed optimal control strategies. The main finding of the study reveals that implementation of protections, COVID-19 vaccine, and treatment strategies simultaneously is the most effective optimal control strategy to tackle the HBV and COVID-19 co-epidemic spreading in the community.

Psychometric properties of the PTSD Checklist for DSM-5 (PCL-5) anchored to one's own suicide attempt.

Emerging evidence indicates that a nontrivial proportion of suicide attempt (SA) survivors develop clinically significant posttraumatic stress disorder (PTSD) symptoms related to their suicide attempt (SA-PTSD). However, SA-PTSD is rarely assessed in either clinical practice or research studies, due at least in part to a lack of research examining approaches to assessing SA-PTSD. This study examined the factor structure, internal consistency, and concurrent validity of scores on a version of the PTSD Checklist for DSM-5 (PCL-5) specifically anchored to one's own SA (PCL-5-SA). We recruited a sample of 386 SA survivors who completed the PCL-5-SA and related self-report measures. A confirmatory factor analysis (CFA) that specified a 4-factor model consistent with the DSM-5 conceptualization of PTSD indicated that the PCL-5-SA had acceptable fit in our sample, χ²(161) = 758.03, RMSEA = 0.10, 90% CI =[0.09-0.11], CFI = 0.90, and SRMR = 0.06. The PCL-5-SA total and subfactor scores demonstrated good internal consistency (ωs = 0.88-0.95). Significant positive correlations of PCL-5-SA scores with anxiety sensitivity cognitive concerns, expressive suppression, depression symptoms, and negative affect provided evidence for concurrent validity (rs = .25-.62). Results suggest that SA-PTSD, when measured with a specific version of the PCL-5, is a conceptually coherent construct that operates consistent with the DSM-5 conceptualization of PTSD stemming from other traumatic events. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Predictors of Success of Adenoidectomy in the Treatment of Pediatric Chronic Rhinosinusitis.

Objectives: There is consensus for adenoidectomy as treatment of chronic rhinosinusitis (CRS) in children younger than 6 years but less consensus for those aged 6 years and older. The present clinical research study investigated predictors of adenoidectomy success for pediatric CRS. Methods: A retrospective chart review was conducted for 107 children who presented to an otolaryngology clinic and had an adenoidectomy for CRS after failure of maximal medical therapy. Results: The majority of sample was male (N = 63; 58.9%) with mean age of 4.88 (SD = 2.54) and mean Lund-Mackay score of 7.76 (SD = 3.87). Patients who had success with adenoidectomy were older on average [mean (M) = 5.46; SD = 2.83] than patients who failed the procedure (M = 4.36; SD = 2.40; F = 4.06, P = .047). This equated to 67.9% of children aged 6 years and older and 39.2% of children younger than 6 years succeeding with the surgery. Conclusions: Adenoidectomy is a good first-line surgery for children aged 12 years and younger, especially in the 6 to 12 years group which had a high rate of success with 68% experiencing remission of symptoms after surgery.

A Narrative Review of the 2023 Korean Thyroid Association Management Guideline for Patients with Thyroid Nodules.

The 2023 Korean Thyroid Association (KTA) Management Guideline for Patients with Thyroid Nodules constitute an update of the 2016 KTA guideline for thyroid nodules and cancers that focuses specifically on nodules. The 2023 guideline aim to offer updated guidance based on new evidence that reflects the changes in clinical practice since the 2016 KTA guideline. To update the 2023 guideline, a comprehensive literature search was conducted from January 2022 to May 2022. The literature search included studies, reviews, and other evidence involving human subjects that were published in English in MEDLINE (PubMed), Embase, and other relevant databases. Additional significant clinical trials and research studies published up to April 2023 were also reviewed. The limitations of the current evidence are discussed, and suggestions for areas in need of further research are identified. The purpose of this review is to provide a summary of the 2023 KTA guideline for the management of thyroid nodules released in May 2023 and to give a balanced insight with comparison of recent guidelines from other societies.

A80 SELF-COMPLETED QUESTIONNAIRES IDENTIFY SYMPTOMS IN A PROPORTION OF PATIENTS WITH CELIAC DISEASE CONSIDERED ASYMPTOMATIC DURING CLINICAL VISITS

Abstract Background Patients with celiac disease (CeD) often experience symptoms despite adhering strictly to a gluten-free diet, and novel therapies are under development to help symptom management. However, recruitment for clinical trials [DA1] can be challenging, as screening is often based on symptoms reported to the physician during a clinic visit. However, symptoms reported by patients during clinic visits may not be an accurate reflection of the true extent of the symptoms. Aims To assess whether gastrointestinal (GI) symptoms reported by patients to physicians during a clinic visit differ from those self-reported in questionnaires on the same day. Methods A retrospective chart review of patients enrolled in the celiac registry (HiREB #5415, #16758) was performed. We included adult patients enrolled in our celiac registry from January 2021 to August 2023. We collected data on demographics such as age, sex, gender, time since CeD diagnosis (early diagnosis defined as within 2 years versus late diagnosis as greater than 2 years), CeD serology (TTG, DGP, EmA), in addition to GI symptoms 1) reported to the physician during the clinic visit, and 2) recorded on a validated questionnaire (Gastrointestinal Symptoms Rating Scale - GSRS) completed on the same day. A GSRS score greater than 30 for overall GI symptoms and a score greater than 2 for any individual symptom was considered symptomatic. Results We reviewed a total of 174 patient charts that met the inclusion criteria during the defined time period. Overall, 107 patients reported symptoms during the clinic visit; of the remaining 67 patients who did not report symptoms at the clinic visit, 29 (43.2%) were identified as symptomatic by the GSRS. Compared to the clinical history, the GSRS identified higher rates of abdominal pain (77% vs 12.6%, p=0.0001), diarrhea (44.8% vs 11.4%, p=0.0001), bloating (87.3% vs 30.5%, p=0.0001), GERD (55.1% vs 5.1%, p=0.0001), constipation (57.4% vs 15.2%, p=0.0001) and nausea (56.3% vs 10.8, p=0.0001). There were no differences in responses between clinical visits and GSRS when subgrouped by gender, age, time since diagnosis or disease activity. Conclusions Self-reported questionnaires identify a subgroup of patients with celiac disease who reported GI symptoms when completing a validated questionnaire despite reporting no symptoms during a clinic visit. Screening patients for clinical research studies is often based on symptoms reported to the physician during the clinical visit, and therefore this has direct implications for research recruitment in gastroenterology clinical trials. Funding Agencies None

Comparison of electronic health records and electronic source data in clinical research trials: a retrospective review

Accurate documentation of medications and medical history is a critical component in ensuring the integrity of subject data in clinical research trials. With a mandate to use electronic health records (EHR) in healthcare settings, there has been a parallel movement towards integrating EHR and electronic data capture (EDC) software in clinical trials to improve efficiency and accuracy of data entry. However, there is increasing evidence that EHR data tend to be erroneous. The present study is a retrospective review comparing the medications and medical history documented in the EHR versus the EDC of subjects in active, ongoing clinical research studies to assess the validity of the assumption of the utility of using EHR data directly. Our results show significant data deviation from the EHR to the EDC, where 98% of all records were modified for clarity in some capacity. Only 31.3% of all medication records were concordant, and only 45.7% of all medical problem records were concordant. This suggests that Principal Investigators play a crucial role in parsing out incomplete, inaccurate, and irrelevant information when transferring data from the EHR to the EDC.

Banff scoring of kidney allograft biopsies: “Manual” application vs software-assisted sign-out

Abstract Objectives Pathologists interpreting kidney allograft biopsies using the Banff system usually start by recording component scores (eg, i, t, cg) using histopathologic criteria committed to memory. Component scores are then melded into diagnoses using the same manual/mental processes. This approach to complex Banff rules during routine sign-out produces a lack of fidelity and needs improvement. Methods We constructed a web-based “smart template” (software-assisted sign-out) system that uniquely starts with upstream Banff-defined additional diagnostic parameters (eg, infection) and histopathologic criteria (eg, percent interstitial inflammation) collectively referred to as feeder data that is then translated into component scores and integrated into final diagnoses using software-encoded decision trees. Results Software-assisted sign-out enables pathologists to (1) accurately and uniformly apply Banff rules, thereby eliminating human inconsistencies (present in 25% of the cohort); (2) document areas of improvement; (3) show improved correlation with function; (4) examine t-Distributed Stochastic Neighbor Embedding clustering for diagnosis stratification; and (5) ready upstream incorporation of artificial intelligence–assisted scoring of biopsies. Conclusions Compared with the legacy approach, software-assisted sign-out improves Banff accuracy and fidelity, more closely correlates with kidney function, is practical for routine clinical work and translational research studies, facilitates downstream integration with nonpathology data, and readies biopsy scoring for artificial intelligence algorithms.