Data Capture Forms Research Articles

Violence study of healthcare workers and systems in the Caribbean: ViSHWaS-Caribbean study.

Violence against healthcare workers (HCWs) in the Caribbean continues to prevail yet remains underreported. Our aim is to determine the cause, traits, and consequences of violence on HCWs in the Caribbean. To determine the cause, traits, and consequences of violence on HCWs in the Caribbean. This research adopted an online cross-sectional survey approach, spanning over eight weeks (between June 6th and August 9th, 2022). The survey was generated using Research Electronic Data Capture forms and followed a snowballing strategy to contact individuals using emails, social media, text messages, etc. Logistic regression analysis was performed to evaluate the variables that influence violence, including gender, age, years of experience, institution type, and night shift frequency. The survey was completed by 225 HCWs. Females comprised 61%. Over 51% of respondents belonged to the 21 to 35 age group. Dominica (n = 61), Haiti (n = 50), and Grenada (n = 31) had the most responses. Most HCWs (49%) worked for government academic institutions, followed by community hospitals (23%). Medical students (32%), followed by attending physicians (22%), and others (16%) comprised the most common cadre of respondents. About 39% of the participants reported experiencing violence themselves, and 18% reported violence against colleague(s). Verbal violence (48%), emotional abuse (24%), and physical misconduct (14%) were the most common types of violence. Nearly 63% of respondents identified patients or their relatives as the most frequent aggressors. Univariate logistic regression analyses demonstrated that female gender (OR = 2.08; 95%CI: 1.16-3.76, P = 0.014) and higher frequency of night shifts (OR = 2.22; 95%CI: 1.08-4.58, P = 0.030) were associated with significantly higher odds of experiencing violence. More than 50% of HCWs felt less motivated and had decreased job satisfaction post-violent conduct. A large proportion of HCWS in the Caribbean are exposed to violence, yet the phenomenon remains underreported. As a result, HCWs' job satisfaction has diminished.

Assessing the implications of using RDTS in donor blood screening for transfusion-transmissible infections (TTIs): analysis of trans-in donor blood at a Tertiary Hospital in Ghana

BackgroundBlood transfusion is a critical hemotherapeutic intervention. However, the widespread utilization of Rapid Diagnostic Test (RDT) methods in screening potential donors for TTIs poses a serious public health challenge. We investigated the prevalence of TTIs in donor blood units that were transported from external health facilities (Trans-in blood) to Ho Teaching Hospital for critical care. MethodWe adopted a cross-sectional design to investigate 727 units of Trans-in blood at the Ho Teaching Hospital's blood bank between January 1, 2021, to December 31, 2022. An apriori-developed data capture form was used to collect the data for this study. The chi-square test and Cramer's V or Phi were used to assess the association between variables of interest. Binary logistic regression analysis was used to determine the association between TTIs and donor's blood groups whereas spatial visualization was employed to present the distribution of missed TTIs. ResultsThe overall prevalence of missed TTIs was 6.19 % (95 % CI: 4.66–8.18), comprising missed HIV, HBV, and Syphilis infection rates of 1.79 % (95 % CI: 1.72–1.86), 1.24 % (95 % CI: 1.17–1.31), and 3.16 % (95 % CI: 3.09–3.23), respectively. There was a higher rate of missed HIV infections in 2022 (2.04 %, 95 % CI: 1.04–3.97) compared to 2021 (1.49 %, 95 % CI: 0.64–3.45), and a decline in the rates of missed HBV and Syphilis infection within the period. The prevalence of TTI was highest among donors with ABO blood group 'O' (68.89 %, 95 % CI: 54.34–80.47) and Rh 'D' Positive blood group (95.56 %, 95 % CI: 85.17–98.77). Compared to donors with blood group O, non-O donors had 4.53 times the odds (95 % CI: 1.12–18.27; p-value=0.034) of missed HBV infection. ConclusionThe observed prevalence of missed TTIs highlights potential gaps in current screening practices, posing a significant public health concern. Efforts made to clamp down on the spread of these infections within the population may be impeded if the current trend of missed TTIs continues. Further studies on a larger scale with more comprehensive data are advised to better appreciate the public health implications of missed TTIs in Ghana.

From the Confessional Booth to Digital Enclosures: Absolution as Cultural Technique

This article examines the confessional booth as an architected space that, by serving as a geo-epistemological enclosure, prefigures digital forms of data capture and production. In conversation with critical scholarship about ‘confessional culture,’ it analyzes how confessionals and digital enclosures embody different historical iterations of a cultural technique that promises absolution – understood as a cleansing process of transparent exposure. It argues that, with digital enclosures, the renunciative self-mortification that lies at the heart of classic Christian confession is reprogrammed into what Byung-Chul Han calls a ‘pornographic self-presentation.’ The self-death dealt by the confessional thus becomes an apparently voluntary self-exploitation for the social media subject. In both cases, however, absolution governs via rituals of cathartic transparency, submitting interiority to processes of legible exteriorization and articulating the subject via an exhibitive logic that blurs the boundaries between communicative freedom and compulsory self-exposure.

Examining the Clinical Outcomes of a Soft Silicone Multilayer Foam Dressing for Exudate Management in US Hospitals: It Is Time to Optimize Dressing Change Frequency

Background. Acute and chronic wounds in the acute hospital setting are commonly managed with soft silicone multilayer foam dressings (SSMFDs). While many SSMFDs are indicated for wear time of up to 7 days, they are often changed more frequently. Objective. To use real-world data on dressing change practices and clinical outcomes to examine whether a built-in indicator on a proprietary SSMFD could reduce unnecessary dressing changes. Materials and Methods. Health care professionals (HCPs) were screened and recruited from a health care research panel to complete per wound data capture forms. Outcomes reported included dressing wear time, healing rates, dressing change frequency, user satisfaction, and adverse events. Outcomes were reported as an aggregated data set. Results. A total of 53 wounds were analyzed. The mean treatment period was 23.83 days, which included dressing changes every 2 to 3 days on average. Of the 53 cases analyzed, the unique change indicator on the SSMFD was used to guide dressing change frequency 98% of the time. Overall, 21% of wounds completely healed (n = 11), 70% (n = 37) showed improvement, 9% (n = 5) were static, and 0% deteriorated. Conclusion. Real-world data on use of the proprietary SSMFD in an acute setting indicates that the SSMFD can allow for the optimization of dressing change protocols to enable appropriate dressing change frequency, allowing for undisturbed healing and maximizing HCP and dressing resources.

Assessment of Medication Prescribing Indicators Using the World Health Organization Standard Indices in a Tertiary Hospital in Ilorin, Nigeria

Background: Drug use is the most common option in treating disease conditions in clinical practice. Irrational prescription and use of medicine have become a major problem in Africa. The patterns of medication prescription in this environment have been under-studied. Evaluating these patterns is essential to provide information that may guide actions towards improving the prescription standards and mitigate the problems associated with irrational prescription and use of medicine. The study aimed to assess medication prescribing patterns by all cadres of doctors in the General Outpatient Department of the University of Ilorin Teaching Hospital (UITH) using the World Health Organization (WHO) prescribing indicators. Methods: It was a six-month retrospective study of medication prescription by all cadres of the doctors attending to outpatients in the General Outpatient Department of UITH between 1st July, 2022 – 31st December, 2022. A validated data capture form was used for the study following the WHO prescribing indicator guidelines. The results were displayed using the arithmetic means, frequencies, and percentages. Results were interpreted by the recommended ideal values by the WHO. Results: 1,650 prescriptions were reviewed, 914 were included in the study. This study found that all the analyzed prescription indices fell short of the WHO-recommended threshold. An average of 2.25 medications were prescribed per patient. The percentages of encounters with injections, antibiotics, and other medications by generic name were 87.2%, 66.9%, and 73.2%, respectively. 53.8% of the medications prescribed came from the essential medicine list. Conclusion: All medication prescribing indicators assessed were found to be below the ideal value recommended by WHO. Therefore, we advocated for the training of prescribers and the formulation of policies that will promote the prescription of medications in line with WHO guidelines.

You & Me: Test and Treat study protocol for promoting COVID-19 test and treatment access to underserved populations

BackgroundInfections and deaths from the COVID-19 pandemic have disproportionately affected underserved populations. A community-engaged approach that supports decision making around safe COVID-19 practices is needed to promote equitable access to testing and treatment. You & Me: Test and Treat (YMTT) will evaluate a systematic and scalable community-engaged protocol that provides rapid access to COVID-19 at-home tests, education, guidance on next steps, and information on local resources to facilitate treatment in underserved populations.MethodsThis direct-to-participant observational study will distribute at-home, self-administered, COVID-19 testing kits to people in designated communities. YMTT features a Public Health 3.0 framework and Toolkit prescribing a tiered approach to community engagement. We will partner with two large community organizations, Merced County United Way (Merced County, CA) and Pitt County Health Department (Pitt County, NC), who will coordinate up to 20 local partners to distribute 40,000 COVID tests and support enrollment, consenting, and data collection over a 15-month period. Participants will complete baseline questions about their demographics, experience with COVID-19 infection, and satisfaction with the distribution event. Community partners will also complete engagement surveys. In addition, participants will receive guidance on COVID-19 mitigation and health-promoting resources, and accessible and affordable therapeutics if they test positive for COVID-19. Data collection will be completed using a web-based platform that enables creation and management of electronic data capture forms. Implementation measures include evaluating 1) the Toolkit as a method to form community-academic partnerships for COVID-19 test access, 2) testing results, and 3) the efficacy of a YMTT protocol coupled with local resourcing to provide information on testing, guidance, treatment, and links to resources. Findings will be used to inform innovative methods to address community needs in public health research that foster cultural relevance, improve research quality, and promote health equity.DiscussionThis work will promote access to COVID-19 testing and treatment for underserved populations by leveraging a community-engaged research toolkit. Future dissemination of the toolkit can support effective community-academic partnerships for health interventions in underserved settings.Trial registrationClinicalTrials.gov Identifier: NCT05455190. Registered 13 July 2022.

AI Consent Futures: A Case Study on Voice Data Collection with Clinicians

As new forms of data capture emerge to power new AI applications, questions abound about the ethical implications of these data collection practices. In this paper, we present clinicians' perspectives on the prospective benefits and harms of voice data collection during health consultations. Such data collection is being proposed as a means to power models to assist clinicians with medical data entry, administrative tasks, and consultation analysis. Yet, clinicians' attitudes and concerns are largely absent from the AI narratives surrounding these use cases, and the academic literature investigating them. Our qualitative interview study used the concept of an informed consent process as a type of design fiction, to support elicitation of clinicians' perspectives on voice data collection and use associated with a fictional, near-term AI assistant. Through reflexive thematic analysis of in-depth sessions with physicians, we distilled eight classes of potential risks that clinicians are concerned about, including workflow disruptions, self-censorship, and errors that could impact patient eligibility for services. We conclude with an in-depth discussion of these prospective risks, reflect on the use of the speculative processes that illuminated them, and reconsider evaluation criteria for AI-assisted clinical documentation technologies in light of our findings.

ViSHWaS: Violence Study of Healthcare Workers and Systems—a global survey

ObjectiveTo provide insights into the nature, risk factors, impact and existing measures for reporting and preventing violence in the healthcare system. The under-reporting of violence against healthcare workers (HCWs) globally...

Capability, Opportunity, and Motivation Model for Behavior Change in People With Asthma: Protocol for a Cross-Sectional Study.

Asthma is a common lung condition that cannot be cured, but it can usually be effectively managed using available treatments. Despite this, it is widely acknowledged that 70% of patients do not adhere to their asthma treatment. Personalizing treatment by providing the most appropriate interventions based on the patient's psychological or behavioral needs produces successful behavior change. However, health care providers have limited available resources to deliver a patient-centered approach for their psychological or behavioral needs, resulting in a current one-size-fits-all strategy due to the nonfeasible nature of existing surveys. The solution would be to provide health care professionals with a clinically feasible questionnaire that identifies the patient's personal psychological and behavioral factors related to adherence. We aim to apply the capability, opportunity, and motivation model of behavior change (COM-B) questionnaire to detect a patient's perceived psychological and behavioral barriers to adherence. Additionally, we aim to explore the key psychological and behavioral barriers indicated by the COM-B questionnaire and adherence to treatment in patients with confirmed asthma with heterogeneous severity. Exploratory objectives will include a focus on the associations between the COM-B questionnaire responses and asthma phenotype, including clinical, biological, psychosocial, and behavioral components. In a single visit, participants visiting Portsmouth Hospital's asthma clinic with a diagnosis of asthma will be asked to complete a 20-minute questionnaire on an iPad about their psychological and behavioral barriers following the theoretical domains framework and capability, opportunity, and motivation model. Participants' data are routinely collected, including demographics, asthma characteristics, asthma control, asthma quality of life, and medication regime, which will be recorded on an electronic data capture form. The study is already underway, and it is anticipated that the results will be available by early 2023. The COM-B asthma study will investigate an easily accessible theory-based tool (a questionnaire) for identifying psychological and behavioral barriers in patients with asthma who are not adhering to their treatment. This will provide useful information on the behavioral barriers to asthma adherence and whether or not a questionnaire can be used to identify these needs. The highlighted barriers will improve health care professionals' knowledge of this important subject, and participants will benefit from the study by removing their barriers. Overall, this will enable health care professionals to use effective individualized interventions to support improved medication adherence while also recognizing and meeting the psychological needs of patients with asthma. ClinicalTrials.gov NCT05643924; https://clinicaltrials.gov/ct2/show/NCT05643924. DERR1-10.2196/44710.

Clinical decision support with a comprehensive in-EHR patient tracking system improves genetic testing follow up.

We sought to develop and evaluate an electronic health record (EHR) genetic testing tracking system to address the barriers and limitations of existing spreadsheet-based workarounds. We evaluated the spreadsheet-based system using mixed effects logistic regression to identify factors associated with delayed follow up. These factors informed the design of an EHR-integrated genetic testing tracking system. After deployment, we assessed the system in 2 ways. We analyzed EHR access logs and note data to assess patient outcomes and performed semistructured interviews with users to identify impact of the system on work. We found that patient-reported race was a significant predictor of documented genetic testing follow up, indicating a possible inequity in care. We implemented a CDS system including a patient data capture form and management dashboard to facilitate important care tasks. The system significantly sped review of results and significantly increased documentation of follow-up recommendations. Interviews with key system users identified a range of sociotechnical factors (ie, tools, tasks, collaboration) that contribute to safer and more efficient care. Our new tracking system ended decades of workarounds for identifying and communicating test results and improved clinical workflows. Interview participants related that the system decreased cognitive and time burden which allowed them to focus on direct patient interaction. By assembling a multidisciplinary team, we designed a novel patient tracking system that improves genetic testing follow up. Similar approaches may be effective in other clinical settings.

Lifestyle and environmental risk factors for unexplained male infertility: study protocol for Australian Male Infertility Exposure (AMIE), a case–control study

BackgroundApproximately 1 in 20 men are sub-fertile or infertile yet the aetiologies of male infertility remain largely unexplained. It is suggested that lifestyle choices and environmental factors contribute but research is limited. In particular, no study has evaluated early life exposures and subsequent male infertility. To address this knowledge gap, this study aims to characterise a cohort of men with idiopathic infertility and compare their general health, lifestyle choices and environmental exposures from teenage years onwards to men without reproductive abnormalities.MethodsTwo groups of men (N = 500 cases; N = 500 controls), matched for age and socio-economic status, will be recruited from fertility clinics around Australia between June 2021 and June 2024. Men will be eligible if they are between 18 and 50 years, with a female partner less than 42 years, and have identified idiopathic male infertility (case) or are part of a couple with diagnosed female factor infertility but with no indication of compromised male fertility (control). Participants will complete an in-depth survey on general health, lifestyle and environmental exposures, reporting from teenage years onwards. An online medical data capture form will be used to gather fertility assessment information from participant medical records. Biological specimens of saliva (all study participants), blood and urine (optional) will be collected and stored for future genetic and epigenetic analysis. Differences in outcome measures between cases and controls will be determined using appropriate between groups comparisons. The relationship between explanatory variables and infertility will be analysed using multilevel modelling to account for clustering within fertility clinics.DiscussionThis study addresses an important gap in research on the aetiology of male infertility and will provide a comprehensive profile of the lifestyle and environmental risk factors for male infertility, leading to provision of up-to-date health advice for male teenagers and adults about optimising their fertility.

Recent trends in the patterns of dyslipidemia and management strategy in newly diagnosed patients of type 2 diabetes mellitus-2

Background: Objective of the study was to evaluate the patterns of dyslipidaemia in newly diagnosed type 2 diabetes mellitus-2 (T2DM) patients and to understand the initial management options utilised by the treating physician.Methods: The real world, retrospective, observational REcent trends in the patterns of dyslipidemia and Management strategy in newly diAgnosed Patients of type 2 diabetes mellitus-2 (REMAP-2) study was conducted at various centers including hospitals, clinics, and health care institutes across India between Apr-2021 and Mar-2022. Clinicians at the respective center captured the data in REMAP-2 study data capture form. Dyslipidemia was considered as: total cholesterol >200 mg/dl, low density lipoprotein cholesterol (LDL-C) >100 mg/dl, high density lipoprotein cholesterol (HDL-C) <40 mg/dl, or triglyceride >150 mg/dl.Results: Of 9605 newly diagnosed T2DM patients with dyslipidemia, 68.94% (n=6622) had mixed dyslipidemia. The mean age was 53.8 years. Majority of the patients were males (63.3%), had family history of diabetes (52.5%), physical activity category of ‘not very active’ or ‘lightly active’ (79.33%), and were overweight or obese (58.9%). About 25.9% of the patients were smokers. Hypertension (72.33%) was the most common comorbidity followed by coronary artery disease (23.44%). The mean glycated hemoglobin (HbA1c) was 8.3%. The most commonly prescribed antidiabetic medication was metformin (87.71%), while lipid lowering therapy was atorvastatin (77.79%).Conclusions: This study on newly diagnosed T2DM patients with dyslipidemia found that majority of the patients had hypertriglyceridemia, family history of diabetes and were physically inactive. More than half of T2DM patients were either overweight or obese. More than 2/3rd of the patients had mixed dyslipidemia. Statins were prescribed to the majority of these patients and atorvastatin was the most commonly prescribed statin in Indian T2DM patients with dyslipidemia.

The CAPNET multi-center data set for child physical abuse: Rationale, methods and scope

BackgroundThe pediatric subspecialty of Child Abuse Pediatrics (CAP) was certified by the American Board of Medical Subspecialties in 2006. Relative to its impact on pediatric health, CAP-focused research has been relatively under-funded. Multi-center networks related to CAP-focused research have made important advances, but have been limited in scope and duration. CAPNET is multi-center network whose mission is to support CAP-focused research. ObjectiveTo describe the rationale, development, and scope of the CAPNET research network infrastructure, the CAPNET data registry and associated data resources. MethodsBased on existing priorities for CAP-focused research, we used consensus building and iterative testing to establish inclusion criteria, common data elements, data quality assurance, and data sharing processes for children with concerns of physical abuse. ResultsWe describe the rationale, methods and intended scope for the development of the CAPNET research network and data registry. CAPNET is currently abstracting data for children <10 years (120 months) old who undergo sub-specialty evaluation for physical abuse at 10 US pediatric centers (approximately 4000 evaluations/year total) using an online data capture form. Data domains include: demographics; visit timing and providers, medical/social history, presentation, examination findings, laboratory and radiographic testing, diagnoses, outcomes, and data for contact children. We describe the methods and criteria for collecting and validating data which are broadly available to CAP investigators. ConclusionsCAPNET represents a new data resource for the CAP research community and will increase the quantity and quality of CAP-focused research.

EConsult for Provider-to-Provider Consultation

&#x0D; The main cost considerations related to electric consultation (eConsult) can be grouped as start-up or infrastructure costs (e.g., equipment, developing electronic forms, creating workflows, and web page design), remunerations, (e.g., for primary care providers, specialist, and auxiliary staff), and societal cost (e.g., productivity loss, time spent travelling, cost of fuel to travel).&#x0D; Considerations for a successful integration of eConsult models into clinical workflows may be broadly categorized into pre-implementation factors (e.g., appropriate training for staff, anticipating and addressing potential barriers or concerns, and having contingency plans for technological failures), implementation factors (e.g., ensuring availability of appropriate data collection and processing devices and software, defining appropriateness of eConsult, building efficiency into the design by using standardized data capture forms, maximizing auto-populating data fields to reduce documentation time, ensuring appropriate confidential documentation, and emphasizing critical information).&#x0D; There were limitations in that no papers were identified to address the questions regarding ethical and professional considerations for the collection, use, and disclosure of protected health information, or the strengths and limitations of a standalone eConsult versus an eConsult platform integrated within an electronic medical records system. Furthermore, although the included studies contained some useful answers, they were not designed to address any of the research questions. Thus, well-designed studies focusing on the individual questions may be necessary for more comprehensive answers.&#x0D;

SURG-12. Endoscopic evaluation of ventricular dissemination in primary central nervous system (CNS) germ cell tumors (GCTs)

Abstract INTRODUCTION: Endoscopic third ventriculostomy and endoscopic tumor biopsy have become integral to the surgical management of children with primary CNS GCTs. Observing ependymal tumor dissemination at the time of endoscopic surgery has been anecdotally reported. The incidence and impact of this finding in CNS GCT has not been reported. METHODS: Baseline neurosurgery data capture forms and operative reports from the Children’s Oncology Group (COG) ACNS1123 study were reviewed for ventriculoscopic findings of suspected tumor dissemination. The association between these findings and relapse was determined using Fisher’s exact test for each stratum and the Cochran-Mantel-Haenszel test for the entire cohort. Progression-free survival (PFS) was defined as time from enrollment to relapse, progression, death, or last follow-up; and survival probabilities were estimated using the Kaplan-Meier method with log-rank tests for outcome comparisons. RESULTS: 110/244 patients (45.1%) underwent endoscopic neurosurgery. Twelve patients (10.9%) had a documented observation suggestive of metastatic disease within the ventricular compartment. Ten were in the third ventricle and two were in the lateral ventricle. Nine of 12 were nongerminomatous germ cell tumors (NGGCTs) and three were germinoma. Ventriculoscopic findings of metastatic tumor were not significantly associated with relapse in NGGCT (p=0.4091), germinoma (p=0.1832), or overall (p=0.1540); odds ratio 2.57 (95%CI:0.66–10.11). PFS was not influenced in NGGCT (Log-rank test, p=0.1953) but was negatively impacted in germinoma (p=0.0250) when tumor dissemination was found during ventriculoscopy. CONCLUSIONS: Ventriculoscopic observation of tumor dissemination was reported in 10.9% of cases. This may negatively influence outcomes in children with germinoma, though due to the small number of relapses, more data is needed to verify these findings. Ventriculoscopic observation of tumor dissemination may contribute toward more accurate staging and influence future therapy, but a larger sample size is needed. Prospective studies should routinely integrate documentation of endoscopic observation in the study protocol.

Emergency department presentations of alcohol and other substance misuse: first cross-sectional national study in Qatar

ObjectivesThis study attempts the first in a series of investigations into the misuse of alcohol and substances in Qatar. This study explores the emergency presentations of alcohol and substance abuse...

Multicentre Retrospective Analysis of Chronic Lymphocytic Leukaemia Patients Treated with Idelalisib, “Real World” Data from the UK and Republic of Ireland - a Cohort of 68 Patients

INTRODUCTIONIn 2014, idelalisib, an oral PI3Kδ (phosphoinositide 3-kinase delta) inhibitor, was approved in combination with rituximab for refractory/relapsed (RR) Chronic Lymphocytic Leukaemia (CLL). Idelalisib has significant activity in the treatment naïve and RR setting, including those with poor prognostics (17p-/TP53 mutated). In published trials idelalisib has a manageable adverse event profile. However, there have been subsequent safety concerns pertaining to infection-related mortality, Cytomegalovirus (CMV) reactivation, Pneumocystis jiroveci pneumonia (PJP), hepatitis, pneumonitis, intestinal perforation and colitis. There is a paucity of real life data.AIMSTo present “real world” data, detailing Event Free Survival (EFS) and treatment-related toxicities, in patients receiving idelalisib based therapy.METHODSData was collected retrospectively via a standardised data capture form. All prescribing centres (n=112) within the United Kingdom (UK) and Republic of Ireland (ROS) were contacted by email. Trial patients were included. Poor prognostic disease was defined as 17p-, TP53 mutated, 11q- or ATM deleted. It was not possible to document IWCLL response due to selective re-staging. Minimum duration of treatment for inclusion was 3 months.RESULTSSixty-eight patients were analysed, treated between April 2013 to July 2017. Median age was 77 years (range: 50 - 91), 46/68 being male. Median number of prior therapies was 2 (range: 0-7; 9 first line), including rituximab, fludarabine, alemtuzumab and bendamustine. The majority (51/68) had good performance status (Eastern Cooperative Oncology Group 0/1). TP53 mutated/17p- disease accounted for 26/68 (38%), and 11q-/ATM mutated 9/68 (13%; 3 additional TP53 mutations).Median duration of treatment was 12 months (range 3-49), of which 24% (16/68) completed ≥24 months of treatment. Three patients (4%) had no response.Disease-related cytopenias, irrespective of a persisting lymphocytosis, resolved in 78% (51/65), 82% (51/62) and 88% (42/48) at 3, 6 and 12 months. Radiological CR/PR was reported in 71% (PR 10/21; CR 5/21), 70% (11/27 PR; 8/27 CR) and 69% (4/16 PR; 7/16 CR) at 3, 6 and 12 months respectively. Only 1 patient progressed radiologically within the first 6 months. Bone marrow CR/PR was reported in 64% (7/14 PR; 2/14 CR), 69 % (6/17 PR; 5/16 CR) and 75% (3/8 PR; 3/8 CR) at 3, 6 and 12 months.Median EFS (defined as progression, death [including post-Idelalisib discontinuation] or treatment discontinuation) was 15 months (low risk 14 months; high risk 16 months; p=0.3). Sixty-five percent (44/68) of the cohort remained on therapy at 12 months, 22% (15/68) ≥24 months.Diarrhoea/colitis was the commonest toxicity, 22/68 patients (32%), of which half were grade ≥3. Toxicities include haematological 28% (5/19 grade≥3), rash 19% (3/13 grade≥3), hepatotoxicity 19% (4/13 grade≥3), pneumonitis 14% (n=10), PCP infection 7% (n=5, prophylaxis regime unclear) and CMV reactivation 4% (n=3; no CMV infection pre-Idelalisib).Treatment interruption due to drug toxicity was reported in 32/68 patients (diarrhoea/colitis n=10; infections n=11). The median number of drug interruptions was 1 (range: 1-4), median duration off therapy 30 days (range: 7 - 180). In 37/68 patients (54%) idelalisib was discontinued (n=12 progression; n=13 diarrhoea/colitis; n=6 recurrent infection; pneumonitis n=4; hepatotoxicity n=2). Twenty deaths (29%) were recorded but only 3 occurred on Idelalisib (1 therapy-related). Nine of 12 patients that had progressed died at time of analysis.CONCLUSIONWe report one of the first “real-world” cohorts treated with idelalisib. This was a relatively elderly multiply treated population, although with good performance status, 51% had poor prognostics which did not confer an inferior outcome. Median number of cycles was 12 (admixed - first line/relapsed) with an EFS of 15 months. Median treatment duration has been reported up to 22.4 months in the up-front setting (O'Brien et al. 2015; Blood). Thirty seven percent of patients discontinued therapy due to toxicity, mostly due to diarrhoea/colitis, comparable to other publications (Thompson et al. 2016; Cancer). Risk profile can be reduced with PCP prophylaxis, CMV surveillance and following consensus guidelines on toxicity management. Idelalisib remains an efficacious treatment for CLL, with 22% of the cohort continuing on therapy at 24 months. [Display omitted] DisclosuresPatten:Gilead Inc: Honoraria, Research Funding; Roche: Honoraria; Abbvie: Honoraria. Gohil:UCL Business: Patents & Royalties. Iyengar:Gilead Inc: Honoraria; Janssen: Honoraria. Nathwani:UCL Business: Patents & Royalties. Heath:Gilead Inc: Honoraria. Ayto:Gilead Inc: Honoraria.

Clinical relevance of comprehensive genomic profiling for advanced cancers in India.

e18718 Background: Comprehensive genomic profiling (CGP) assay, a next-generation sequencing (NGS) based technique generates a large amount of genomic information about a cancer. While CGP is increasingly used in low-middle income countries (LMIC), little is known about the extent to which these benefits patients. Here we describe the proportion of patients with advanced cancer in India who eventually receive targeted therapy for an actionable genetic alteration identified on CGP assays. Methods: This was a multicenter, retrospective cohort study in adult patients with advanced non-hematological malignancies who underwent a CGP test. We excluded patients who were identified to have a genetic alteration that has a well-validated targeted standard-of-care therapy (e.g.; EGFR exon 18, 19, 21 mutations for lung cancer, HER2 amplification for breast cancer). Participating oncologists provided anonymized information of consecutive CGP test reports through an online data capture form. Descriptive statistics were used to describe the proportion of patients with subsequent targeted therapy. Results: During 2019-20, 12 medical oncologists provided CGP reports for 297 patients; 235 met the inclusion criteria. Fourteen different testing panels were used by the oncologists. Among the study cohort, 45% were male. Eighty nine percent underwent tumor tissue biopsy and 11% had liquid biopsy. The most common cancers were lung (19%), breast (18%), pancreatobiliary (9%) and colorectal (6%). Patients received a median of 2 lines (range: 0-5) of prior systemic therapy. Based on the CGP assay, 35 patients (15%) received targeted therapy. Among them, 29% was for HER2 amplification (non-breast cancer), 26% for PIK3CA mutation, 11% for HER2 or EGFR exon 20 insertion mutation (lung cancer), 5% each for BRAF mutation (non-melanoma), EGFR mutation (non-lung cancer) and MET mutation. Conclusions: In a LMIC setting, 15% patients received a targeted therapy based on CGP assay. This is comparable to reports from high income countries. Considering the limited access to new drugs and clinical trials, this finding requires further analysis.

Factors influencing peri-operative delays in neurosurgery operating theatres: a prospective study

BackgroundReduction of perioperative delays optimises theatre efficiency, and may provide an opportunity to improve the quality of healthcare delivered. The aim of this quality improvement project was to elucidate the prevalence, causes and impact of perioperative delays in Neurosurgery theatres at our local institution. MethodsA prospective audit analysing elective Neurosurgery cases was conducted from 1st Sept ‘18 to 28th Feb ’19 (6 months).Quantitative and qualitative analysis was performed on data from the Operating Room Scheduling Office System (ORSOS) real-time data capture forms and a custom-made survey filled out by theatre staff. NHS Benchmarking Network national neurosurgery theatre data were utilised as a control group. ResultsA total of 461 (90%) cases started late (average delay of 49 minutes and 21 seconds), 32% (n=164) cases finished early and 31 minutes was the average turnaround time. There was 16.8%(n=124) cancellation rate and 76% theatre utilisation. The most commonly cited causes for late start were lack of patient readiness (62.1%), change in list order (5.3%), anaesthetic delay (5.3%), surgeon delay (4.5%), turnaround delay (2.3%), bed issues (2.3%), emergency (1.5%), fire alarm (0.8%), kit delay (0.8%) and multi-factorial (15.2%). The total cost of late start delays over the study period was £304,266.18. ConclusionsThis study showed late-starts and early-finishes as part of sub-optimal theatre utilisation. Cost-saving could be immense if corporate factors improve such as availability of appropriate beds along with clinical ‘human’ factors. To ameliorate these delays, we are currently implementing strategies to improve compliance of lumbar spinal surgery as day-case guideline. In order to ensure long-term sustainability, this implementation will be re-audited using a Plan-Do-Study-Act cycle in 6 months’ time.

Study protocol for COvid-19 Vascular sERvice (COVER) study: The impact of the COVID-19 pandemic on the provision, practice and outcomes of vascular surgery.

The novel Coronavirus Disease 2019 (COVID-19) pandemic is having a profound impact on global healthcare. Shortages in staff, operating theatre space and intensive care beds has led to a significant reduction in the provision of surgical care. Even vascular surgery, often insulated from resource scarcity due to its status as an urgent specialty, has limited capacity due to the pandemic. Furthermore, many vascular surgical patients are elderly with multiple comorbidities putting them at increased risk of COVID-19 and its complications. There is an urgent need to investigate the impact on patients presenting to vascular surgeons during the COVID-19 pandemic. The COvid-19 Vascular sERvice (COVER) study has been designed to investigate the worldwide impact of the COVID-19 pandemic on vascular surgery, at both service provision and individual patient level. COVER is running as a collaborative study through the Vascular and Endovascular Research Network (VERN), an independent, international vascular research collaborative with the support of numerous national and international organisations). The study has 3 'Tiers': Tier 1 is a survey of vascular surgeons to capture longitudinal changes to the provision of vascular services within their hospital; Tier 2 captures data on vascular and endovascular procedures performed during the pandemic; and Tier 3 will capture any deviations to patient management strategies from pre-pandemic best practice. Data submission and collection will be electronic using online survey tools (Tier 1: SurveyMonkey® for service provision data) and encrypted data capture forms (Tiers 2 and 3: REDCap® for patient level data). Tier 1 data will undergo real-time serial analysis to determine longitudinal changes in practice, with country-specific analyses also performed. The analysis of Tier 2 and Tier 3 data will occur on completion of the study as per the pre-specified statistical analysis plan.