Data Capture System Research Articles

Anticoagulation Interventions by Pharmacists in Acute Care.

Clinical pharmacy key performance indicators (cpKPIs) relate to activities performed by pharmacists that have been shown to improve patient outcomes. Within Saskatchewan Health Authority (SHA) Regina, most cpKPIs are incorporated into the organization's clinical practice standards, which provide guidance in prioritizing care, especially for high-risk medications, including anticoagulants. To track pharmacists' interventions associated with clinical practice standards, a locally developed electronic data-capture system (known as AIM High) was implemented. To quantify and describe pharmacists' anticoagulation interventions on 16 wards with dedicated ward-based clinical pharmacists and to compare intervention rates between the cardiology and internal medicine wards to further evolve the organization's practice model. Data from the electronic data-capture system were retrospectively analyzed for a 5-year period (January 2016 to December 2020). A total of 94 201 interventions were recorded in the AIM High system (average 362 interventions per week or 26 interventions per pharmacist per week). Of these, 15 661 (16.6%) cited the anticoagulation standard (average 60 anticoagulation interventions per week or 4 anticoagulant interventions per pharmacist per week). For the cardiology and internal medicine wards, 4183 of 11 888 (35.2%) and 9034 of 54 843 (16.5%) interventions cited the anticoagulation standard, respectively. The top 4 types of anticoagulation interventions were dose changed (n = 4372 or 27.9%), drug started or restarted (n = 3867 or 24.7%), patient education (n = 3094 or 19.8%), and drug discontinued (n = 2944 or 18.8%). Dedicated ward-based clinical pharmacists were following clinical practice standards incorporating the majority of cpKPIs to complete anticoagulation interventions. The types of anticoagulation interventions evolved over time and were influenced by the patient population.

Software development process of Neotree - a data capture and decision support system to improve newborn healthcare in low-resource settings.

The global priority of improving neonatal survival could be tackled through the universal implementation of cost-effective maternal and newborn health interventions. Despite 90% of neonatal deaths occurring in low-resource settings, very few evidence-based digital health interventions exist to assist healthcare professionals in clinical decision-making in these settings. To bridge this gap, Neotree was co-developed through an iterative, user-centered design approach in collaboration with healthcare professionals in the UK, Bangladesh, Malawi, and Zimbabwe. It addresses a broad range of neonatal clinical diagnoses and healthcare indicators as opposed to being limited to specific conditions and follows national and international guidelines for newborn care. This digital health intervention includes a mobile application (app) which is designed to be used by healthcare professionals at the bedside. The app enables real-time data capture and provides education in newborn care and clinical decision support via integrated clinical management algorithms. Comprehensive routine patient data are prospectively collected regarding each newborn, as well as maternal data and blood test results, which are used to inform clinical decision making at the bedside. Data dashboards provide healthcare professionals and hospital management a near real-time overview of patient statistics that can be used for healthcare quality improvement purposes. To enable this workflow, the Neotree web editor allows fine-grained customization of the mobile app. The data pipeline manages data flow from the app to secure databases and then to the dashboard. Implemented in three hospitals in two countries so far, Neotree has captured routine data and supported the care of over 21,000 babies and has been used by over 450 healthcare professionals. All code and documentation are open source, allowing adoption and adaptation by clinicians, researchers, and developers.

Healthcare professionals’ perception of safety culture and the Operating Room (OR) Black Box technology before clinical implementation: a cross-sectional survey

IntroductionComprehensive data capture systems such as the Operating Room Black Box (OR Black Box) are becoming more widely implemented to access quality data in the complex environment of the OR....

Assessment of Menstrual Health and Bleeding Symptoms in Adolescent Girls and Young Women with Sickle Cell Disease

Introduction: Sickle Cell Disease (SCD) is traditionally associated with thrombotic events such as venous thromboembolism and cerebrovascular events. However, adults with SCD have an increased cumulative incidence of bleeding complications by 40 years of age, including heavy menstrual bleeding (HMB). HMB affects 40% of adolescent girls in the general population and is a common reason for referral to pediatric hematology clinics. Whether adolescent girls and young women with SCD are similarly affected by HMB and other bleeding manifestations have not been well described. This purpose of this study was to assess the menstrual health status of this population and to estimate the prevalence of HMB and other bleeding symptoms. Methods: Menarchal adolescent girls and young women aged 12-21 years old, diagnosed with any SCD genotype, and followed in one of three pediatric hematology clinics at a large tertiary care children's hospital were approached for a cross-sectional study. The study consisted of a 5-part questionnaire administered through the Research Electronic Data Capture (REDCap) system. The questionnaire included collection of demographic information, menstrual health knowledge assessment, menstrual bleeding medication rating profile, and validated instruments for patient-reported HMB outcomes and historical bleeding symptoms. The patient-reported outcome instruments consisted of the one-month recall Menstrual Bleeding Questionnaire (MBQ) and Self-Administered Bleeding Assessment Tool (Self-BAT). Statistical procedures involved chi-squared test and Kruskal-Wallis test. Statistical significance was set at p<0.05. Results: To date, 38 participants have completed the questionnaire. The mean age of the study cohort was 15.9 ± 2.3 years. Individuals with SCD genotype HbSS comprised the majority of the cohort and 53% (n = 20) reported hydroxyurea use (Table 1). Mean age of menarche was 13 years (min-max 10-15 years). On the menstrual health knowledge assessment, 6 participants (16%) correctly identified all four characteristics of normal menstruation per American College of Obstetricians and Gynecologists (ACOG) definitions. Specifically, 50% correctly identified the expected duration of menses and 45% identified all of the pharmacologic categories available for menstrual regulation. Parents/guardians were the primary source of menstrual health knowledge (84%), while social media/internet was the predominant secondary source (29%). The mean MBQ score was 14.1 ± 8.5. For comparison, the MBQ validation study performed in adult women with and without HMB reported a mean MBQ score of 30.8 ± 14 and 10.6 ± 8.6, respectively. Approximately 55% of participants reported moderate or severe pain related to menstrual cycles. Pain was not significantly associated with age, hydroxyurea use, or self-reported history of HMB. Ibuprofen (16%) and acetaminophen (11%) were the main medications listed for menstrual pain relief. For the Self-BAT, abnormal bleeding scores are classified as ≥3 in children and ≥6 in women. The cohort mean Self-BAT score was 1.6 (min-max 0-8) and 29% (n = 11) had abnormal bleeding scores. Bleeding symptoms reported were post-surgical/trauma-induced bleeding, epistaxis, prolonged bleeding from small cuts, and bleeding after tooth extraction. Interestingly, 12 participants (32%) reported a history of HMB on the Self-BAT. There were no significant differences in MBQ or Self-BAT scores by age and hydroxyurea use, although individuals with HMB had significantly higher MBQ and Self-BAT scores (Table 2). Six participants (50%) with HMB attempted ≥1 hormonal therapy method for menstrual regulation. One additional participant without HMB received hormonal therapy. Conclusions: In this study, we demonstrate that 32% of adolescent girls and young women with SCD reported a history of HMB and the majority of participants reported moderate/severe pain related to their menstrual cycle. Yet, only 50% with HMB attempted a hormonal therapy. Furthermore, most of the participants had reduced knowledge of normal menstrual health. These findings suggest a critical need for improved education and patient/provider discussion regarding menstruation. Ultimately, incorporating menstrual health assessment into SCD care is important for optimizing patient health and addressing health inequities in the adolescent and SCD population. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Study Design of the Japanese Association of Cardiac Rehabilitation Registry (J-CARRY) - Protocol for a Prospective, Multicenter, Open Registry.

Background: Guidelines for the prevention and management of cardiovascular disease (CVD) highly recommend cardiac rehabilitation (CR) on the basis of abundant evidence of its effectiveness. However, the current understanding and dissemination of CR in Japan are far from sufficient. Methods and Results: The Japanese Association of Cardiac Rehabilitation Registry (J-CARRY) is an academic society-led prospective multicenter observational registry conducted by the Registration and Facility Accreditation System Committee of the Japanese Association of Cardiac Rehabilitation. Data are collected prospectively using an electronic data capture system. Items related to patients' clinical background and CR, as well as mortality and major adverse cardiac and cerebrovascular events, will be collected in all cases. This Registry started in May 2014, and the number of participating medical institutions is expected to increase to >30; the targeted number of cases exceeded 3,000 per year as of April 30, 2022. Focusing on late Phase II data collection is a novel and significantly different approach compared with previous studies. The results of this study are currently under investigation. Conclusions: J-CARRY will provide real-world data regarding the current status and prognosis of CVD in patients who undergo Phase II CR in Japan.

Web-Based System to Capture Consistent and Complete Real-world Data of Physical Therapy Interventions Following Total Knee Replacement: Design and Evaluation Study.

Electronic health records (EHRs) have the potential to facilitate consistent clinical data capture to support excellence in patient care, quality improvement, and knowledge generation. Despite widespread EHR use, the vision to transform health care system and its data to a "learning health care system" generating knowledge from real-world data is limited by the lack of consistent, structured clinical data. The purpose of this paper was to demonstrate the design of a web-based structured clinical intervention data capture system and its evaluation in practice. The use case was ambulatory physical therapy (PT) treatment after total knee replacement (TKR), one of the most common and costly procedures today. To identify the PT intervention type and intensity (or dose) used to treat patients with knee arthritis following TKR, an iterative user-centered design process refined an initial list of PT interventions generated during preliminary chart reviews. Input from practicing physical therapists and national and international experts refined and categorized the interventions. Next, a web-based, hierarchical structured system for intervention and intensity documentation was designed and deployed. The PT documentation system was implemented by 114 physical therapists agreeing to record all interventions at patient visits. Data for 161 patients with 2615 PT visits were entered by 83 physical therapists. No technical problems with data entry were reported, and data entry required less than 2 minutes per visit. A total of 42 (2%) interventions could not be categorized and were recorded using free text. The use of user-centered design principles provides a road map for developing clinically feasible data capture systems that employ structured collection of uniform data for use by multiple practitioners across institutions to complement and augment existing EHRs. Secondarily, these data can be analyzed to define best practices and disseminate knowledge to practice.

Evaluating the Accuracy of the Annual Statewide Kindergarten Vaccination Survey Submitted to Public Health Authorities by School Systems, Oklahoma, 2018.

Recent trends in vaccine hesitancy have brought to light the importance of using accurate school vaccination data. This study evaluated the accuracy of a pilot statewide kindergarten vaccination survey in Oklahoma. School vaccination and exemption data were collected from November 2017 to April 2018 via the Research Electronic Data Capture system. A multivariable linear regression model was used to evaluate the relationship between students who are up to date for all vaccines comparing school reported and Oklahoma State Department of Health-validated data. Adjusted vaccination data were overestimated by 1.0% among public schools and 3.3% among private schools. These results were validated by a random audit of participating schools finding the school-reported vaccination data to be overestimated by 0.6% compared to true student immunization records on file. Our analysis indicates that school-reported vaccination data are sufficiently valid. Immunization record audits provide confidence in available data, which drives evidence-based decision-making.

Bilateral verses bilateral with tri-segmental endoscopic drainage using metal stents for high-grade malignant hilar biliary obstructions: A multicenter, randomized controlled trial: BRAVE study (BRAVE study).

Introduction:Bilateral endoscopic drainage with self-expanding metallic stent (SEMS) can be used to manage hilar malignant biliary obstruction (HMBO) more effectively in comparison to unilateral drainage. An increased drainage area is predicted to prolong stent patency and patient survival. However, few reports have described the utility of trisegmental drainage and the benefits of using trisegmental drainage remain unknown. Thus, we launched a randomized clinical trial (RCT) to compare the clinical outcomes between bilateral and trisegmental drainage using SEMSs in patients with high-grade HMBO.Methods and analysis:This study was conducted as a multicenter randomized control trial (RCT) in 8 high-volume medical centers in Japan, and will prove the non-inferiority of bilateral drainage to trisegmental drainage. Patients with unresectable HMBO with Bismuth type IIIa or IV who pass the inclusion and exclusion criteria will be randomized to receive bilateral or trisegmental drainage at a 1:1 ratio. At each center, the on-site study investigators will obtain informed consent from the candidates, and will use an electronic data capture system (REDCap) to input necessary information, and register candidates with the registration secretariat. The primary endpoint is the rate of non-recurrent biliary obstruction (RBO) at 180 days after SEMSs placement. A −10% non-inferiority margin is assumed in the statistical analysis of the primary endpoint. Secondary endpoints include the rate of technical and clinical success, time to recurrent biliary obstruction (TRBO), causes of RBO, procedure-related adverse events (AEs), procedure time, TRBO with or without endoscopic sphincterotomy, overall survival, and the technical and clinical success rates at reintervention.Discussion:If the non-inferiority of bilateral drainage is demonstrated, it is predicted that the procedure time will be shortened and the medical cost will be reduced, which will be beneficial to the patient and the medical economy.Trial registration:Registered in Japan Registry of Clinical Trial-Registration (trial number. jRCTs062220038). This version number 1. Protocol dated Jun 23, 2022.

Patient-centred care: reality or rhetoric—patients’ experiences at ARV clinics located in public hospitals in KwaZulu-Natal, South Africa

BackgroundThe South African public antiretroviral therapy (ART) programme is considered one of the largest and most successful ART programmes worldwide. Hence, a study exploring the patients’ experiences of the public antiretroviral therapy (ART) programme in the second decade of the programme is relevant as no study has been published on patients’ experiences at these sites.ObjectivesTo explore patients’ experiences of care in the public ART programme at four ARV clinics within the eThekwini District, KwaZulu-Natal.MethodA mixed-methods study design with 12 in-depth patient interviews, non-participatory observation, and a stratified random sample of 400 patients completed questionnaires. Qualitative data were thematically analysed. Quantitative data were analysed using a SPSS 24 package to determine frequencies and differences in patients’ responses (p < 0.05). The socio-ecological model framed the study.ResultsAll 412 patients reported valuing the provision of free ARVs. Patients’ positive experiences included: routine blood results mostly being available, most staff greeted patients, there were sufficient nurses, patients were satisfied with the time that they spent with doctors, clean clinics, and private and safe counselling areas. The negative experiences included: poor relationships with nurses, negative staff attitudes, disrespectful staff, information was lacking, inadequate counselling at times, varying and inflexible appointments, challenges with data capture and registration systems; varying ARV collection frequencies, routine health tests and processes per site, and the absence of patient committees and representatives.ConclusionThe results reflected positive and negative experiences which varied between the facilities, as processes and systems differed at each site. Innovative patient-centred processes and programmes could be implemented to ensure patients have mostly positive experiences. As part of continuous improvement, patients’ experiences should be regularly explored to ensure that the ART programme meets their needs and expectations.

Identifying the association rules between adverse events and concomitant medicines in clinical trial data management using random forest

Adverse events (AEs) and concomitant medications (CMs) underreporting remains a recurrent issue in clinical trials. This study aimed to build a mapping relationship between the AE and CM using a random forest (RF) model that can be embedded in the current Electronic Data Capture (EDC) system, to enable a reliable detection of underreporting AE or CM. Current data including 524 AEs and 684 CMs for 13,905 individuals, were taken from three cancer clinical trials and six other studies that are non-public. An additional validation dataset was consisted of 448 independent patients with 269 unique AEs and 407 CMs from a cancer clinical trial on Paclitaxel. We found that the machine learning method exhibited in a learning task between AE and CM well for a common AE like hypertension that was caused by a single cause, but it was ineffective when the AE, such as the increased blood alkaline phosphatase, was caused by complex reasons or just an associated symptom of some diseases. This study suggests the potential of automatically detecting the underreported AE and CM in detail, and it will improve further safety and validity inspections from clinical trials. ABBREVIATIONS: AE, adverse event; ATC, anatomical therapeutic chemical; CM, concomitant medication; EDC, electronic data capture; FDA, Food and Drug Administration; GCP, good clinical practice; MedDRA, medical dictionary for regulatory activities; NMPA, National Medical Products Administration; PT, preferred term; RCT, randomized controlled trial; RF, random forests; SDV, source data verification; VIM, variable importance measure

The Japanese Catheter Ablation Registry (J-AB): Annual report in 2020.

The Japanese Catheter Ablation (J‐AB) registry, started in August 2017, is a voluntary, nationwide, multicenter, prospective, observational registry, performed by the Japanese Heart Rhythm Society (JHRS) in collaboration with the National Cerebral and Cardiovascular Center using a Research Electronic Data Capture system. The purpose of this registry is to collect the details of target arrhythmias, the ablation procedures, including the type of target arrhythmias, outcomes, and acute complications in real‐world settings. During the year 2020, we have collected a total of 84 591 procedures (mean age of 65.8 years and 66.6% male) from 466 participant hospitals. Detailed data were shown in Figures and Tables.

Quantifying the primary and secondary effects of antimicrobial resistance on surgery patients: Methods and data sources for empirical estimation in England.

Antimicrobial resistance (AMR) may negatively impact surgery patients through reducing the efficacy of treatment of surgical site infections, also known as the “primary effects” of AMR. Previous estimates of the burden of AMR have largely ignored the potential “secondary effects,” such as changes in surgical care pathways due to AMR, such as different infection prevention procedures or reduced access to surgical procedures altogether, with literature providing limited quantifications of this potential burden. Former conceptual models and approaches for quantifying such impacts are available, though they are often high-level and difficult to utilize in practice. We therefore expand on this earlier work to incorporate heterogeneity in antimicrobial usage, AMR, and causative organisms, providing a detailed decision-tree-Markov-hybrid conceptual model to estimate the burden of AMR on surgery patients. We collate available data sources in England and describe how routinely collected data could be used to parameterise such a model, providing a useful repository of data systems for future health economic evaluations. The wealth of national-level data available for England provides a case study in describing how current surveillance and administrative data capture systems could be used in the estimation of transition probability and cost parameters. However, it is recommended that such data are utilized in combination with expert opinion (for scope and scenario definitions) to robustly estimate both the primary and secondary effects of AMR over time. Though we focus on England, this discussion is useful in other settings with established and/or developing infectious diseases surveillance systems that feed into AMR National Action Plans.

Investigating the self-perceived educational priorities among oncology nurses

AimTo understand the self-perceived educational priorities among oncology nurses. BackgroundOncology nurses are the main providers of care to people affected by cancer. However, little is known about the educational needs and priorities of oncology nurses when providing care to people living with cancer. DesignA national online survey. SettingThe Cancer Nurses Society of Australia (CNSA) is an Australian wide professional body for cancer nurses. At the time of conducting the research, there were approximately 1300 members. All members were invited to participate in the survey. CNSA provided access to nurses working in all areas of cancer care, including inpatient wards, outpatient centres, ambulatory day oncology units, radiation oncology, bone marrow transplant units, educational, and research units. ParticipantsRegistered nurses involved in direct care of people affected by cancer who were members of CNSA, and ability to communicate in English. MethodsThe instrument consisted of a 15-item online questionnaire which included demographic and professional questions related to the self-perceived oncology educational needs which were free-text. This survey was hosted using an online electronic data capture system (i.e., SurveyMonkey®), and the electronic link was sent to the CNSA who then sent an email invitation to the 1300 members. Results610 educational needs were identified and ranked. These individual answers were grouped into seven overarching categories with various sub-categories within each group. The oncology nurses identified important educational topics which included: a) cancer biology, b) treatments, c) direct patient care, d) age-specific cancer care, e) leadership and research, and f) law and ethics. ConclusionAs the number of people affected by cancer continue to rise, addressing the educational needs and priorities of oncology nurses has never been so important. Higher educational institutions and healthcare institutions should consider these findings in addressing the learning needs for the current oncology nursing workforce.

Effectiveness of a complex intervention of group-based nutrition and physical activity to prevent frailty in pre-frail older adults (SUPER): a randomised controlled trial

The increasing prevalence of frailty with age is becoming a public health priority in countries with ageing populations. Pre-frailty presents a window of opportunity to prevent the development of frailty in community-dwelling older adults. This study aimed to examine the effectiveness of a complex intervention that combined a nutrition-based intervention and a physical activity intervention, along with the effectiveness of each intervention individually, to reduce physical frailty in pre-frail older adults over 2 years. In this single-blind, 2 x 2 factorial, randomised, controlled trial, we recruited pre-frail community-dwelling older adults in Aotearoa New Zealand via mail through general medical practices. To be eligible, participants had to be pre-frail according to self-reported FRAIL scores of 1 or 2, aged 75 years or older (or 60 years or older for Māori and Pacific Peoples), not terminally ill or with advanced dementia as judged by a general practitioner, able to stand, medically safe to participate in low-intensity exercise, and able to use kitchen utensils safely. Participants were randomly allocated to receive an 8-week Senior Chef programme (SC group), a 10-week Steady As You Go programme (SAYGO group), a 10-week combined SC and SAYGO intervention (combined group), or a 10-week social programme (control group), using computer-generated block randomisation administered through an electronic data capture system by local study coordinators. Assessors were masked to group allocation for all assessments. SC is a group-based nutrition education and cooking class programme (3 h weekly), SAYGO is a group-based strength and balance exercise programme (1 h weekly), and the social control programme was a seated, group socialising activity (once a week). Masked assessors ascertained Fried frailty scores at baseline, end of intervention, and at 6, 12, and 24 months after the programme. The primary outcome was change in Fried frailty score at 2 years. Intention-to-treat analyses were completed for all randomised participants, and all participants who had a high (≥75%) adherence were analysed per protocol. This study is registered at ANZCTR, ACTRN12614000827639. Between May 12, 2016 and April 9, 2018, we assessed 2678 older adults for eligibility, of whom 468 (17%) consented and completed baseline assessment, with a mean age of 80·3 years (SD 5·1) and a mean Fried score of 1·9 (1·2); 59% were women. We randomly allocated these participants into the four groups: 117 in the SC group, 118 in the SAYGO group, 118 in the combined group, and 115 in the control group; 318 participants attended the 24-month follow-up: 89 in the SC group, 78 in the SAYGO group, 73 in the combined group, and 78 in the control group. At the 24-month follow-up, there were no differences in mean Fried scores between the intervention groups and the control group. No adverse events were reported. The study did not find that the combined SC and SAYGO programme was effective in reducing frailty in pre-frail older adults. Although some short-term benefits were observed in each individual programme, there was no clear evidence of long-term impact. Further research is needed to evaluate combinations of group-based programmes for community-dwelling older adults to optimise their physical function. Health Research Council New Zealand and Ageing Well Challenge (Ministry of Business Innovation and Employment).

Surgeons' Leadership Style and Team Behavior in the Hybrid Operating Room: Prospective Cohort Study.

This study aimed to assess the relationship between surgeons' leadership style and team behavior in the hybrid operating room through video coding. Secondly, possible fluctuations possible fluctuations in leadership styles and team behavior during operative phases were studied. Leadership is recognized as a key component to successful team functioning in high-risk industries. The 'full range of leadership' theory is commonly used to evaluate leadership, marking transformational, transactional, and passive. Few studies have examined the effects of these leadership styles on team behavior in surgery and/or their fluctuations during surgery. A single-center study included patients planned for routine endovascular procedures. A medical data capture system was used to allow post hoc video coding through Behavior Anchored Rating Scales. Multilevel statistical analysis was performed to assess possible correlations between leadership style and 3 team behavior indicators (speaking up, knowledge sharing, and collaboration) on an operative phase level. Twenty-two cases were analyzed (47 hours recording). Transformational leadership is positively related to the extent to which team members work together (γ=0.20, P <0.001), share knowledge (γ=0.45, P <0.001), and speak up (γ=0.64, P <0.001). Passive leadership is significantly positively correlated with speaking up (γ=0.29, P =0.004). Leadership style and team behavior clearly fluctuate during a procedure, with similar patterns across different types of endovascular procedures. Consistent with other professional fields, surgeons' transformational leadership enhances team behavior, especially during the most complex operative phases. This suggests that encouraging surgeons to learn and actively implement a transformational leadership style is meaningful to enhance patient safety and team performance.

Review on Radiation Therapy Information Systems

Aim: Clinical and pre-clinical radiotherapy data represent one of the most valuable assets for radiation therapy and oncology institutions. The present study aimed to review various clinical information systems used in the field of radiotherapy and the critical success factors influencing the system implementation.&#x0D; Method: This review study was completed in 2022. In this study, papers related to clinical information systems in the field of oncology were retrieved by using keywords. The databases and the search engine were Scopus, PubMed, Science Direct, Web of Knowledge, Ovid, Medline, and Google Scholar and the time frame was between 2010 and 2022. Initially, a total of 427 papers were retrieved, and finally, 18 related papers were selected.&#x0D; Results: The main clinical information systems used in radiotherapy included developing a patient’s electronic chart checks (two studies), establishing a web-based Integrated Radiation Oncology Information Platform, implementing a web-based Electronic Data Capture system, developing a data archiving system, developing a prototype software for the anonymization of radiation therapy treatment plans, creating a national radiation oncology registry, identifying deficiencies in treatment plans and radiotherapy simulation, creating a web-based radiotherapy system and other related studies (nine studies).&#x0D; Conclusion: The use of clinical information systems in the field of radiotherapy is inevitable, mainly due to the wide range of benefits that these systems have. However, to implement these systems successfully, proper choice of technology, user training, application of standards, use of big data, periodic evaluations, as well as workflow identification are required for effective use of these systems.

Excimer laser ablation combined with drug-coated balloon versus drug-coated balloon in the treatment of de novo atherosclerotic lesions in lower extremities (ELABORATE): study protocol for a real-world clinical trial

BackgroundThe efficacy and validity of excimer laser ablation (ELA) in the in-stent restenosis (ISR) has been confirmed. However, its application in de novo atherosclerotic lesions of lower extremity artery disease (LEAD) has not been clearly defined and its procedure has not been standardized.MethodsELABORATE is a prospective, multicenter, real-world study designed to evaluate the efficacy and safety between ELA combined with drug-coated balloon (DCB) and DCB alone in de novo atherosclerotic lesions of LEAD.DiscussionELABORATE is a prospective, multicenter, real-world study designed to assess the efficacy and safety between ELA combined with drug-coated balloon (DCB) and DCB alone in patients with de novo atherosclerotic lesions of LEAD. According to the real-world situation, eligible patients will be allocated to ELA + DCB group (group E) and DCB group (group C). Baseline and follow-up information (at 3, 6, and 12 months) will be collected. The primary efficacy point is primary patency at 12-months, and the secondary efficacy points include clinically driven target lesion reintervention (CD-TLR), change of Rutherford class, ankle-brachial index and ulcer healing rate. These indexes will be assessed and recorded at 3, 6, and 12-month follow-up. Also, safety evaluation, including major adverse event, all-cause mortality through 30-day follow-up, unplanned major amputation, bailout stent and distal embolization, will also be evaluated by an independent core laboratory. All the data will be collected and recorded by the electric data capture system. This study will be finished in 3 years and the 12-month results will be available in 2023. All the patients will be followed for 5 years.Trial registration number Chinese Clinical Trial Registry (ChiCTR2100051263). Registered 17 September 2019. http://www.chictr.org.cn/listbycreater.aspx.

Exploring the scope of 4sb and 12a lymph node dissection for cT2-4 lower third gastric cancer: Study protocol for a prospective cohort trial.

BackgroundCurrently, the extent of 4sb and 12a lymph node dissection is not clear and is based on the personal understanding of the surgeon. It may result in damage to the splenic artery and portal vein, leading to surgical complications. Therefore, this study aims to explore the scope of 4sb and 12a lymph node dissection in cT2-4 lower third gastric cancer.MethodsThis is an ongoing prospective cohort trial. The total sample size required for the trial (March 2022 to February 2025) is approximately 524 patients. The participants are divided into the experimental (4sb first branch and 12a anterior lymphadenectomy) or control groups (traditional 4sb and 12a lymphadenectomy). Electronic data capture systems will be used to collect demographic, laboratory test, auxiliary examination, operation, postoperative condition, postoperative pathology, and follow-up data. The primary outcome is the 12a lymph node metastatic rate. Secondary outcomes include the pathology (consisting of the 4sb lymph node metastatic rate, the number of 4sb lymph nodes dissected, the number of 12a lymph nodes dissected and tumor pathological staging), a safety evaluation index (consisting of complications and mortality ≤30 days after surgery), an efficacy evaluation (consisting of operation data and postoperative recovery status), and follow-up data (consisting of 3-year or 5-year disease-free survival and overall survival).DiscussionBy exploring the scope of 4sb and 12a lymph node dissection on the premise of ensuring radical cure of the tumor, the operation is simplified, the operation time is shortened, the damage of important blood vessels is reduced, the intraoperative and postoperative complications are reduced, and the patient recovers as soon as possible. Our study is a prospective exploration of the pathology, safety, efficacy, and prognosis of the new and traditional methods of 4sb and 12a lymph node dissection.Trial registrationChinese Clinical Trial Registry, ChiCTR2200057698 (registration date: March 15, 2022).

Cancer registry operations in the Caribbean during the COVID-19 pandemic: a report of lessons learned and opportunities identified to support strong and sustainable health systems

BackgroundPopulation-based cancer registries (PBCRs) are crucial for cancer prevention and control planning. Building and maintaining resilient information systems within cancer registries that enable consistent and uninterrupted operations during public health emergencies is important. We report on the impact of the COVID-19 pandemic on the operations of Caribbean PBCRs, together with opportunities, lessons learned, and strategies to strengthen and sustain PBCR operation and data quality.MethodsThe International Agency for Research on Cancer Caribbean Cancer Registry Hub (known as the Hub) was created within the framework of the Global Initiative for Cancer Registry Development, led by the International Agency for Research on Cancer and implemented by the Caribbean Public Health Agency and key partners. The Hub works closely with Caribbean PBCRs to provide training and technical support, conduct research, and promote regional cooperation. Communication between the Hub and individual PBCRs continued throughout the COVID-19 pandemic to establish its impact and to assist with developing resilient strategies to mitigate identified challenges. In 2020, the Hub supported an International Agency for Research on Cancer survey to assess the impact of the COVID-19 pandemic on PBCRs.FindingsTen (77%) of 13 Caribbean registries contacted responded to the survey. The impact of the COVID-19 pandemic on Caribbean PBCRs varied across countries. During the early phases of the pandemic, five (50%) of ten PBCRs reported that the COVID-19 pandemic negatively affected operations, mainly in terms of data collection. Reasons included inability to fully access physical data sources and reduced capacity or inability to receive cancer notifications and files. Less severe effects reported by the other five PBCRs were linked to strong existing registry infrastructure and practices, consistency of financing, and no staffing reduction. These PBCRs took independent initiatives to adapt to changes in registry operations by establishing remote access to data sources and switching from physical to virtual data abstraction when possible. A follow-up survey is underway to assess and characterise the long-term effects of the pandemic on PBCR operations, including data reporting. A crucial need identified is integrated electronic data capture systems, which can complement in-person data abstraction through increased electronic reporting from sources to PBCRs and help to strengthen registry data management systems. In response, the Hub accelerated efforts to pilot the District Health Information Software version 2 Oncology Module, developed by the Rwanda National Cancer Registry, in the Caribbean.InterpretationLessons could be learned from registries, particularly those for which operations remained largely unaffected during the pandemic. Through a better understanding of the impact of the pandemic and by improving the availability of digital solutions, the Hub is supporting efforts to strengthen the resilience of Caribbean PBCRs and health information systems in the face of emergencies.FundingFinancial support for the Hub is provided by the Caribbean Public Health Agency and the US National Cancer Institute, with in-kind support from International Agency for Research on Cancer, the North American Association of Central Cancer Registries, and the US Centers for Disease Control and Prevention. Caribbean PBCRs are funded by their respective Governments. This work received no specific funding.

Re-engineering a Clinical Trial Management System Using Blockchain Technology: System Design, Development, and Case Studies.

BackgroundA clinical trial management system (CTMS) is a suite of specialized productivity tools that manage clinical trial processes from study planning to closeout. Using CTMSs has shown remarkable benefits in delivering efficient, auditable, and visualizable clinical trials. However, the current CTMS market is fragmented, and most CTMSs fail to meet expectations because of their inability to support key functions, such as inconsistencies in data captured across multiple sites. Blockchain technology, an emerging distributed ledger technology, is considered to potentially provide a holistic solution to current CTMS challenges by using its unique features, such as transparency, traceability, immutability, and security.ObjectiveThis study aimed to re-engineer the traditional CTMS by leveraging the unique properties of blockchain technology to create a secure, auditable, efficient, and generalizable CTMS.MethodsA comprehensive, blockchain-based CTMS that spans all stages of clinical trials, including a sharable trial master file system; a fast recruitment and simplified enrollment system; a timely, secure, and consistent electronic data capture system; a reproducible data analytics system; and an efficient, traceable payment and reimbursement system, was designed and implemented using the Quorum blockchain. Compared with traditional blockchain technologies, such as Ethereum, Quorum blockchain offers higher transaction throughput and lowers transaction latency. Case studies on each application of the CTMS were conducted to assess the feasibility, scalability, stability, and efficiency of the proposed blockchain-based CTMS.ResultsA total of 21.6 million electronic data capture transactions were generated and successfully processed through blockchain, with an average of 335.4 transactions per second. Of the 6000 patients, 1145 were matched in 1.39 seconds using 10 recruitment criteria with an automated matching mechanism implemented by the smart contract. Key features, such as immutability, traceability, and stability, were also tested and empirically proven through case studies.ConclusionsThis study proposed a comprehensive blockchain-based CTMS that covers all stages of the clinical trial process. Compared with our previous research, the proposed system showed an overall better performance. Our system design, implementation, and case studies demonstrated the potential of blockchain technology as a potential solution to CTMS challenges and its ability to perform more health care tasks.