Monitoring Visits Research Articles

Anxiety and Risk Perception in Parents of Children Identified by Population Screening as High Risk for Type 1 Diabetes.

To assess anxiety and risk perception among parents whose children screened positive for islet autoantibodies, indicating elevated risk for type 1 diabetes (T1D). The Autoimmunity Screening for Kids (ASK) study identified 319 children age 1 to 17 years at risk for T1D via screening for islet autoantibodies; 280 children with confirmed islet autoantibodies and their caregivers enrolled in a follow-up education and monitoring program to prevent diabetic ketoacidosis at diagnosis. Parents completed questionnaires at each monitoring visit, including a 6-item version of the State Anxiety Inventory (SAI), to assess anxiety about their child developing T1D, and a single question to assess risk perception. At the first ASK follow-up monitoring visit, mean parental anxiety was elevated above the clinical cutoff of 40 (SAI 46.1 ± 11.2). At the second follow-up monitoring visit (i.e., visit 2), mean anxiety remained elevated but started to trend down. Approximately half (48.9%) of parents reported their child was at increased risk for T1D at the initial follow-up monitoring visit (visit 1). Parents of children with more than one islet autoantibody and a first-degree relative with T1D were more likely to report their child was at increased risk. Most parents of autoantibody-positive children have high anxiety about their child developing T1D. Information about the risk of developing T1D is difficult to convey, as evidenced by the wide range of risk perception reported in this sample.

Discrete-Choice Experiment to Understand the Preferences of Patients with Hormone-Sensitive Prostate Cancer in the USA, Canada, and the UK.

Treatment options for patients with metastatic hormone-sensitive prostate cancer (mHSPC) have broadened, and treatment decisions can have a long-lasting impact on patients' quality of life. Data on patient preferences can improve therapeutic decision-making by helping physicians suggest treatments that align with patients' values and needs. This study aims to quantify patient preferences for attributes of chemohormonal therapies among patients with mHSPC in the USA, Canada, and the UK. A discrete-choice experiment survey instrument was developed and administered to patients with high- and very-high-risk localized prostate cancer and mHSPC. Patients chose between baseline androgen-deprivation therapy (ADT) alone and experimentally designed, hypothetical treatment alternatives representing chemohormonal therapies. Choices were analyzed using logit models to derive therelative importance of attributes for each country and to evaluate differences and similarities among patients across countries. A total of 550 respondents completed the survey (USA, 200; Canada, 200; UK, 150); the mean age of respondents was 64.3 years. Treatment choices revealed that patients were most concerned with treatment efficacy. However, treatment-related convenience factors, such as route of drug administration and frequency of monitoring visits, were as important as some treatment-related side effects, such as skin rash, nausea, and fatigue. Patient preferences across countries were similar, although patients in Canada appeared to be more affected by concomitant steroid use. Patients with mHSPC believe the use of ADT alone is insufficient when more effective treatments are available. Efficacy is the most significant driver of patient choices. Treatment-related convenience factors can be as important as safety concerns for patients.

Genomic predictors for early recurrence of hepatocellular carcinoma (HCC) after curative resection.

157 Background: Early recurrence of HCC after curative resection is common. However, the association between genetic alterations and early HCC recurrence, especially in Chinese patients (pts), remains largely unknown. Methods: We retrospectively analyzed 214 formalin-fixed paraffin-embedded (FFPE) tumor specimens of HCC patients that were collected from June 2016 to October 2021. Clinical outcomes related to frequently mutated genes were evaluated in 176 pts with a median follow-up time of 21.9 months. Tumor tissue samples were detected by OncoDrug-Seq 603-gene panel assay through next-generation sequencing. Early recurrence was defined as the appearance of an intra- or extrahepatic tumor nodule within 1 year of curative resection. Results: In multivariate analysis, three tumor suppressor genes related to early recurrence, namely PRDM1, NOTCH3, and MGA. PRDM1 mutations and NOTCH3 mutations were the risk factor for early recurrence (＜1 y after surgical resection) (hazard ratio (HR), 4.22; 95% confidence interval (CI), 1.96-9.06; p＜0.001 ) (HR, 2.96; 95% CI, 1.43-6.13; p=0.003). These two mutated genes were also significantly associated with overall survival (HR, 3.39; 95%CI, 1.23-9.34; p=0.018) (HR, 5.22; 95%CI, 2.10-12.99; p＜0.001). We found a trend toward an increased risk of early recurrence in pts with MGA mutation. (HR, 2.06; 95%CI, 1.05-4.05; p=0.027). Conclusions: Mutations in these three tumor suppressor genes were shown to be shorter time intervals to relapse after curative resection. We also demonstrated that pts who have these markers require more frequent monitoring and follow-up visits.

Utilizing a mixed-methods approach to assess implementation fidelity of a group antenatal care trial in Rwanda.

The Preterm Birth Initiative (PTBi)-Rwanda conducted a cluster randomized controlled trial to assess the impact of group antenatal care (group ANC) on preterm birth, using a group ANC approach adapted for the Rwanda setting, and implemented in 18 health centers. Previous research showed high overall fidelity of implementation, but lacked correlation with provider self-assessment and left unanswered questions. This study utilizes a mixed-methods approach to study the fidelity with which the health centers' implementation followed the model specified for group ANC. Implementation fidelity was measured using two tools, repeated Model Fidelity Assessments (MFAs) and Activity Reports (ARs) completed by Master Trainers, who visited each health center between 7 and 13 times (9 on average) to provide monitoring and training over 18 months between 2017 and 2019. Each center's MFA item and overall scores were regressed (linear regression) on the time elapsed since the center's start of implementation. The Activity Report (AR) is an open-ended template to record comments on implementation. For the qualitative analysis, the ARs from the times of each center's highest and lowest MFA score were analyzed using thematic analysis. Coding was conducted via Dedoose, with two coders independently reviewing and coding transcripts, followed by joint consensus coding. A total of 160 MFA reports were included in the analysis. There was a significant positive association between elapsed time since a health center started implementation and greater implementation fidelity (as measured by MFA scores). In the qualitative AR analysis, Master Trainers identified key areas to improve fidelity of implementation, including: group ANC scheduling, preparing the room for group ANC sessions, provider capacity to co-facilitate group ANC, and facilitator knowledge and skills regarding group ANC content and process. These results reveal that monitoring visits are an important part of acquisition and fidelity of the "soft skills" required to effectively implement group ANC and provide an understanding of the elements that may have impacted fidelity as described by Master Trainers. For interventions like Group ANC, where "soft-skills" like group facilitation are important, we recommend continuous monitoring and mentoring throughout program implementation to strengthen these new skills, provide corrective feedback and guard against skills decay. We suggest the use of quantitative tools to provide direct measures of implementation fidelity over time and qualitative tools to gain a more complete understanding of what factors influence implementation fidelity. Identifying areas of implementation requiring additional support and mentoring may ensure effective translation of evidence-based interventions into real-world settings.

Post-approval process: A challenge for ethics committees.

Ethics committees (ECs) work toward upholding rights, dignity, safety, and well-being of research participants. They are also tasked with conducting oversight pre- and post-approval. ECs face various challenges in their functioning. Post-approval oversight is one of the major challenges, and various studies have stressed the importance of post-approval oversight. The aim of this study was to explore the challenges in the post-approval processes that are faced by the ECs and to suggest solutions to the most common challenges. We conducted a quantitative study contacting member secretaries of different ECs using an online Google Forms questionnaire. The questionnaire consisted of three domains and included questions about the description of the EC, conduct of post-approval activities, and challenges encountered during the post-approval process. We received responses from 61 member secretaries. We were able to identify challenges faced by the EC members in the post-approval process in the areas of site monitoring visit, review of post-approval submission (nonsubmission/incomplete submission/late submission of documents by PI, long time taken by reviewers, nonavailability of reviewers, nonadherence to timeline and too much paperwork), review of serious adverse events, and review of protocol deviations. Our study also noted the difference between accredited/assessed (National Accreditation Board for Hospitals and Healthcare Providers/Forum for Ethical Review Committees in the Asian and Western Pacific Region) ECs versus registered (Central Drugs Standard Control Organisation/Department of Health Research only) ECs by comparing the challenges.

P46 A step toward zero leprosy: experiences of Nepal in leprosy data verification

Abstract Records and reports are the sources of data for health programme planning, monitoring and evaluation. Accurate and timely data are crucial to ensure quality leprosy services, including drug supply, complication management and disability prevention. Data verification and validation are the initial steps to achieve the global goal of zero leprosy. The objectives of leprosy data verification were to strengthen the reporting system, to update personal health records and to provide onsite training to leprosy focal persons. Leprosy data verification was conducted in 15 endemic districts of Nepal by a team of national leprosy programme managers, leprosy focal persons, statisticians, dermatologists, paramedic health workers and World Health Organization consultants. The team visited health facilities that provide leprosy services and their corresponding municipalities from August 2021 to December 2021. The team examined the completeness and accuracy of data and information on the patient card, treatment register and monthly reporting form. Data were then compared with the municipal and national database, and edited, cleaned and verified for duplications, and onsite coaching was provided to the leprosy focal persons. Verification of 1210 health records of 15 districts from four provinces was conducted. The number of new leprosy cases was found to be under-reported by 5.5%. Likewise, under-reporting was observed in released-from-treatment cases (19.2% variation) and transfer-out cases (21.4% variation). Over-reporting was observed in re-treatment cases (7% variation), defaulter cases (10.6% variation) and new paediatric cases (38% variation). Common reasons for data variation were error in counting while reporting, error in compiling data from health facilities and a lack of training of focal persons in data recording and reporting. A limitation of the data verification study was that it was conducted in the selected 15 endemic districts and municipalities only. The study suggested that verification, validation and on-site coaching are effective approaches to obtaining quality data on leprosy. Such programmes can be conducted routinely or even during the integrated monitoring and supervision visits of experts from the centre to the local health facilities but should be carried out at the data entry site.

GD02 (P46) A step towards zero leprosy: experiences of Nepal in leprosy data verification

Abstract Records and reports are the sources of data for health programme planning, monitoring and evaluation. Accurate and timely data are crucial to ensure quality leprosy services, including drug supply, complication management and disability prevention. Data verification and validation are the initial steps to achieve the global goal of zero leprosy. The objectives of leprosy data verification were to strengthen the reporting system, to update personal health records and to provide on-site training to leprosy focal persons. Leprosy data verification was conducted in 15 endemic districts of Nepal by a team of national leprosy programme managers, leprosy focal persons, statisticians, dermatologists, paramedic health workers and World Health Organization consultants. The team visited health facilities that provide leprosy services and their corresponding municipalities from August 2021 to December 2021. The team examined the completeness and accuracy of data and information on the patient card, treatment register and monthly reporting form. Data were then compared with the municipal and national database, edited, cleaned and verified for duplications, and on-site coaching was provided to the leprosy focal persons. Verification of 1210 health records of 15 districts from four provinces was conducted. The number of new leprosy cases was found to be under-reported by 5.5%. Likewise, under-reporting was observed in released-from-treatment cases (19.2% variation) and transfer-out cases (21.4% variation). Over-reporting was observed in re-treatment cases (7% variation), defaulter cases (10.6% variation) and new paediatric cases (38% variation). Common reasons for data variation were error in counting while reporting, error in compiling data from health facilities and lack of training of focal persons in data recording and reporting. A limitation of the data verification study was that it was conducted in the selected 15 endemic districts and municipalities only. The study suggested that verification, validation and on-site coaching are effective approaches to obtaining quality data on leprosy. Such programmes can be conducted routinely or even during the integrated monitoring and supervision visits of experts from the centre to the local health facilities but should be carried out at the data entry site.

Ensuring quality control in a COVID-19 clinical trial during the pandemic: The experience of the Inserm C20–15 DisCoVeRy study

SettingHealth measures taken during the pandemic deeply modified the clinical research practices. At the same time, the demand for the results of the COVID-19 trials was urgent. Thus, the objective of this article is to share Inserm's experience in ensuring quality control in clinical trials in this challenging context. ObjectivesDisCoVeRy is a phase III randomized study that aimed at evaluating the safety and efficacy of 4 therapeutic strategies in hospitalized COVID-19 adult patients. Between March, 22nd 2020 and January, 20th 2021, 1309 patients were included. In order to guarantee the best quality of data, the Sponsor had to adapt to the current sanitary measures and to their impact on clinical research activity, notably by adapting Monitoring Plan objectives, involving the research departments of the participating hospitals and a network of clinical research assistants (CRAs). ResultsOverall, 97 CRAs were involved and performed 909 monitoring visits. The monitoring of 100% of critical data for all patients included in the analysis was achieved, and despite of the pandemic context, a conform consent was recovered for more than 99% of patients. Results of the study were published in May and September 2021. Discussion/conclusionThe main monitoring objective was met thanks to the mobilization of considerable personnel resources, within a very tight time frame and external hurdles. There is a need for further reflection to adapt the lessons learned from this experience to the context of routine practice and to improve the response of French academic research during a future epidemic.

Achieving compliance with the global anti-doping system: the case of AMADA

The article is devoted to the study of achieving compliance with the global anti-doping system standards and norms, on the example of the Azerbaijan National Anti-Doping Agency (AMADA). The author describes the main steps taken by AMADA to develop clean sport and improve the country’s anti-doping legislation, highlights the main stages, program documents, and monitoring visits by international organizations to verify the compliance of the work carried out by AMADA with global standards, norms, and practices. Considering the importance and relevance of preserving and maintaining high ethical standards of athletes’ behavior in sports, the author points out the need for further improvement of the functioning of the anti-doping system and its compliance with global challenges.

Are we missing the beat in cancer end-of-life care: Prevalence and end-of-life monitoring of implantable cardioverter defibrillators in a population-based sample of older adults diagnosed with breast, colorectal, or pancreatic cancer.

e18728 Background: More than 50,000 implantable cardioverter defibrillators (ICDs) are placed in adults aged 65 years and older in the United States each year to manage cardiac arrhythmias. Shared risk profiles between many cancers and heart disease, as well as cardiotoxic effects of anti-cancer treatments suggest individuals with cancer are likely to have ICD devices. Although ICDs have been studied extensively in Europe, little is known about the US population, and even less is known in populations with cancer. ICDs have critical implications for end-of-life care in patients with cancer. Many patients do not include wishes for their ICD in their advanced directives, and end-of-life shocks can cause pain and distress for patients and their families. We evaluated prevalence and end-of-life monitoring of ICDs in a national sample of older adults who had breast, colorectal, or pancreatic cancer. Methods: We analyzed Surveillance, Epidemiology and End Results (SEER) data for first incident breast, colorectal, and pancreas cancer cases linked to Medicare claims (years 2004-2016) in Medicare-beneficiaries aged ³66 years. We evaluated the prevalence of ICDs by cancer stage at diagnosis with descriptive statistics. For patients with late-stage cancer (III or IV) who died in our study period we also evaluated the prevalence of ICD monitoring at the end of life. Because ICD deactivation is not a billable code, we evaluated ICD monitoring as a proxy for having an active device, hence an opportunity to discuss device deactivation. Results: In our sample of 286,015 individuals with cancer, 6.8% of patients had evidence of an ICD in their Medicare claims (6.1% breast, 8.2% colorectal, 5.3% pancreas). Of these, 49.7% had evidence of an ICD before their cancer diagnosis. The prevalence of ICDs was lower among the 60,046 individuals diagnosed with late-stage cancer( p< .001) (5.0% breast, 6.1% colorectal, 4.5% pancreas). Among individuals with late-stage cancer and evidence of an ICD, 27.0% of those who died had ICD monitoring in the last six months of life (21.1% breast, 27.9% colorectal, 29.3% pancreas, p= .001), and 6.2% had monitoring in the last month of life (5.1% breast, 6.5% colorectal, 6.3% pancreas, p= .46). Conclusions: To improve the quality of care at the end-of-life for people with advanced cancer, awareness, communication, and shared decision making about ICD device management options are important considerations. These data suggest there may be opportunities to discuss prognosis and implications of advanced-stage cancer at device monitoring visits or during cardio-oncology visits.

Implementation and recommendation of postpartum visit methods during COVID-19 pandemic: a qualitative study from Indonesia

Background. The Maternal Mortality Rate (MMR) in Indonesia is still a health problem that must be solved. In 2018 and 2019, the postpartum period still dominates maternal mortality in Surabaya. The postpartum visit method is one of the essential things that can affect postpartum services, so it is necessary to evaluate the implementation of the postpartum visit method and recommend visiting methods to improve maternal health. Objective. The study explores the implementation and recommendation of postpartum visit methods during the COVID-19 Pandemic. Materials and Methods. It used a qualitative research type by assessing the interview and observation dept. The instruments used are questionnaires and observation sheets. Researchers conducted interviews with 14 mothers who had completed the postpartum period, five midwives, a stakeholder in the health office and two experts in the field of maternal health. The data is processed using organizing, reduction, coding, description, linking between themes, and data interpretation. Results. Offline visits to health facilities still dominate the implementation of the postpartum visit method. The recommended postpartum visit method combines visits to health facilities, home visits, and telehealth. Besides that, it is necessary to consider maternal postpartum services up to 3 months after delivery, especially for postpartum mothers who have problems. Conclusion. The postpartum visit method during the COVID-19 pandemic, has not run optimally because there are restrictions on offline visits. However, it has not been supported by online monitoring or home visits.

Prospective Detection of Early Lung Cancer in Patients With COPD in Regular Care by Electronic Nose Analysis of Exhaled Breath

Patients with COPD are at high risk of lung cancer developing, but no validated predictive biomarkers have been reported to identify these patients. Molecular profiling of exhaled breath by electronic nose (eNose) technology may qualify for early detection of lung cancer in patients with COPD. Can eNose technology be used for prospective detection of early lung cancer in patients with COPD? BreathCloud is a real-world multicenter prospective follow-up study using diagnostic and monitoring visits in day-to-day clinical care of patients with a standardized diagnosis of asthma, COPD, or lung cancer. Breath profiles were collected at inclusion in duplicate by a metal-oxide semiconductor eNose positioned at the rear end of a pneumotachograph (SpiroNose; Breathomix). All patients with COPD were managed according to standard clinical care, and the incidence of clinically diagnosed lung cancer was prospectively monitored for 2 years. Data analysis involved advanced signal processing, ambient air correction, and statistics based on principal component (PC) analysis, linear discriminant analysis, and receiver operating characteristic analysis. Exhaled breath data from 682 patients with COPD and 211 patients with lung cancer were available. Thirty-seven patients with COPD (5.4%) demonstrated clinically manifest lung cancer within 2 years after inclusion. Principal components 1, 2, and 3 were significantly different between patients with COPD and those with lung cancer in both training and validation sets with areas under the receiver operating characteristic curve of 0.89 (95% CI, 0.83-0.95) and 0.86 (95% CI, 0.81-0.89). The same three PCs showed significant differences (P< .01) at baseline between patients with COPD who did and did not subsequently demonstrate lung cancer within 2 years, with a cross-validation value of 87%and an area under the receiver operating characteristic curve of 0.90 (95% CI, 0.84-0.95). Exhaled breath analysis by eNose identified patients with COPD in whom lung cancer became clinically manifest within 2 years after inclusion. These results show that eNose assessment may detect early stages of lung cancer in patients with COPD.

A monitoring and site visit intervention to reduce sales to minors at packaged liquor outlets.

Selling alcohol to a minor is a serious offence in the New South Wales Liquor Act. However, minors report they can purchase alcohol easily. This study used an intersectoral partnership between the Central Coast Local Health District (CCLHD) Health Promotion Service, and Liquor & Gaming NSW (L&GNSW) Compliance Operations to test a site visit intervention to increase ID checks at packaged liquor outlets (PLOs). As the current legislative framework does not allow minors to attempt to purchase alcohol from PLOs, even under compliance operations, this study employed pseudo-minors aged 18-19 years. Pseudo-minors visited all PLOs on the Central Coast, NSW in four survey rounds, attempting to purchase alcohol without ID. If a PLO sold alcohol to the pseudo-minor, they received a visit from a Health Promotion Officer and L&GNSW Inspector to inform them of the sale and that they are at risk of selling alcohol to a minor. Site visits were an effective intervention to increase the rates of ID checking. Alcohol sales to pseudo-minors without ID decreased from 34% in Round 1 to 7% in Round 4. Young sales staff and independent stores were less likely to check ID. This intervention was associated with some of the lowest rates of underage alcohol purchasing reported to date. However, it may not be sustainable in the long term. It is recommended that: future studies randomise site visits to investigate their contribution to the observed reduction, cost effectiveness of the intervention is explored and legislative change to allow controlled purchase operations for alcohol is considered. SO WHAT?: Young people under 18 years of age should not be able to purchase alcohol from liquor licence outlets, and strong laws apply if a sale is detected. However, despite these rules, young people still report they can access alcohol in this manner. Whilst our intervention of site visits with the regulatory body saw decreases in sales to our pseudo-minors, we advocate for controlled purchase operations (similar to tobacco control) as a more sustainable and effective intervention to reduce sales to minors - while this is not yet legislated for packaged liquor outlets in Australia, it is deemed best practice in other countries.

780 Injury to Intervention: Is There Another Opportunity to Improve Burn Care?

Abstract Introduction The treatment of burn-injured patients requires early intervention to prevent adverse events such as local or systemic infection, increased mortality, or exacerbation of other homeostatic processes. Early intervention also reduces delays in treatment, return to work, and the related costs of hospitalization, wound care, and pain control. The purpose of this study was to evaluate potential delays in treatment and the associated costs compared to those seen with more accurate diagnosis and treatment on admission. Methods A prospective, IRB-approved study was undertaken with nine burn centers in nine states and three ABA burn regions. Data points included times of injury, admission, and surgery. Inclusion criteria included: life expectancy &amp;gt; 6 months, thermal burn mechanism (flame, scald, or contact), and minimum burn wound size for adult or pediatric patients of 0.5% TBSA. Data was collected by onsite research staff and confirmed during periodic monitoring visits. Avoidable inpatient days (AID) was defined as the time of admission to the time of surgery, and avoidable treatment delays (ATD) as the time of injury to the time of surgery. The average daily bed costs were defined as $7,554 from recent real-world published data. Results One hundred thirty-eight (138) patients in this study were admitted and treated with surgical intervention for full thickness burn injuries from 2017 to 2022. The total AID was 506 (median 3 days, range 0-9, mean 4, 25%tile 3, 75% 4). The total ATD was 733 days for 138 patients (median 5 days, range 0-9, mean 5, 25%tile 4, 75%tile 6). The median AID cost savings were calculated at $22,662 per patient had surgery been indicated and performed within 24 hours of admission. The median ATD cost savings were $30,216 per patient had surgery been indicated and conducted within 24 hours of injury or evaluation at an emergency room or burn center. The total savings for 138 patients whose surgery had been determined necessary and performed within 24 hours of the burn would have been $4,169,808 as opposed to having surgery indicated and completed within 24 hours of admission, $2,084,904. Conclusions If early diagnosis of burn injuries requiring surgery could be obtained within 24 hours of injury or admission, facilities and patients would benefit from reduced treatment delays and inpatient care costs. Our study was limited to patients undergoing surgery and those with non-healing wounds. An additional benefit could also be found in patients with healing wounds; if a confident diagnosis could be made earlier, such patients could be discharged rather than spending excess time as inpatients. Further studies are in progress with larger populations and more burn centers to better determine benefits for these patients. Applicability of Research to Practice We must understand the economic impact of our clinical decisions to pursue research initiatives that are clinically significant to our patients and financially viable to the institutions that support burn care.

Head circumferences measured during developmental monitoring visits before diagnosis of pediatric craniopharyngioma

Searchable abstracts of presentations at key conferences in endocrinology ISSN 1470-3947 (print) | ISSN 1479-6848 (online)

Polyrhachis femorata (Hymenoptera: Formicidae) habitat and colony defensive immobility strategy

Many animal species ‘play dead’ or feign death (in some cases called tonic immobility) as a defence strategy against predators, including some ants, although triggers and durations are poorly understood. We repeatedly observed such death-feigning behaviour in Polyrhachis femorata ants that occupied pygmy-possum nest boxes deployed on Kangaroo Island following the 2019–2020 bushfires that burnt half of the island. Most of the 759 bat and pygmy-possum boxes (901 cavities) were on burnt ground. In 3312 box cavity checks on 13 diverse properties during monitoring visits, 28 of 40 P. femorata records (first for South Australia) occurred in unburnt Critically Endangered Narrow-Leaf Mallee Woodland community, seven in adjacent mallee community containing narrow-leaf mallee, three in cup gum unburnt habitat, and two in one box on burnt ground. Fire may have affected the abundance and re-establishment of the species. Polyrhachis femorata engages in a surprising defensive immobility strategy in boxes, since it is not only undertaken by individuals facing a potential predator, but also by entire colonies. The death-feigning behaviours were complemented by plugging box entrances. Nest boxes may be used to study this mysterious behaviour in this poorly known species, although frequent observation could lead to nest abandonment by the ant.

The effects of primary care monitoring strategies on COVID-19 related hospitalisation and mortality: a retrospective electronic medical records review in a northern Italian province, the MAGMA study

Background Most symptomatic SARS-CoV-2 infections produce mild to moderate symptoms. Although most patients are managed in the outpatient setting, little is known about the effect of general practitioners’ (GP) management strategies on the outcomes of COVID-19 outpatients in Italy. Objectives Describe the management of Italian GPs of SARS-CoV-2 infected adult patients and explore whether GP active care and monitoring are associated with reducing hospitalisation and death. Methods Retrospective observational study of SARS-CoV-2 infected adult outpatients managed by GPs in Modena (Italy) from March 2020 to April 2021. Information on management and monitoring strategies, patients’ socio-demographic characteristics, comorbidities, and outcomes (hospitalisation and death due to COVID-19) were retrieved through an electronic medical record review and analysed descriptively and through multiple logistic regression. Results Out of the 5340 patients from 46 GPs included in the study, 3014 (56%) received remote monitoring, and 840 (16%) had at least one home visit. More than 85% of severe or critical patients were actively monitored (73% daily) and 52% were visited at home. Changes over time in patients’ therapeutic management were observed in concordance with the guidelines’ release. Active daily remote monitoring and home visits were strongly associated with reduced hospitalisation rate (OR 0.52, 95% CI 0.33–0.80 and OR 0.50, 95% CI 0.33–0.78 respectively). Conclusion GPs effectively managed an increasing number of outpatients during the first waves of the pandemic. Active monitoring and home visits were associated with reduced hospitalisation in COVID-19 outpatients.

Management of Patients Affected by Giant Cell Arteritis during the COVID-19 Pandemic: Telemedicine Protocol TELEMACOV.

Giant cell arteritis (GCA) is the most common primary systemic vasculitis in western countries, prevalently affecting elderly people. Both early diagnosis and regular monitoring are necessary for the correct management of GCA. Following the outbreak of the COVID-19 pandemic, government decisions aiming at reducing the contagion led to reductions in health activities, limiting them to urgent cases. At the same time, remote monitoring activities have been implemented through telephone contacts or video calls carried out by specialists. In line with these deep changes affecting the worldwide healthcare system and in consideration of the high risk of GCA morbidity, we activated the TELEMACOV protocol (TELEmedicine and Management of the patient affected by GCA during the COVID-19 pandemic) in order to remotely monitor patients affected by GCA. The aim of this study was to evaluate the effectiveness of telemedicine in the follow-up of patients already diagnosed with GCA. This was a monocenter observational study. Patients with a previous diagnosis of GCA admitted to the Rheumatology Unit of the University Hospital "Città della Salute e della Scienza" in Turin were monitored every 6-7 weeks by means of video/phone calls from 9 March to 9 June 2020. All patients were asked questions concerning the onset of new symptoms or their recurrence, exams carried out, changes in current therapy, and satisfaction with video/phone calls. We performed 74 remote monitoring visits in 37 GCA patients. Patients were mostly women (77.8%) and had a mean age of 71.85 ± 9.25 years old. The mean disease duration was 5.3 ± 2.3 months. A total of 19 patients received oral glucocorticoids (GC) alone at the time of diagnosis with a daily dose of 0.8-1 mg/kg (52.7 ± 18.3 mg) of prednisone, while 18 patients were treated with a combination of oral steroids (at the time of diagnosis, the prednisone mean dose was 51.7 ± 18.8 mg) and subcutaneous injections of tocilizumab (TCZ). During the follow-up, patients additionally treated with TCZ reduced their GC dose more than patients treated with GC alone (p = 0.03). Only one patient, who was treated with GC alone, had a cranial flare and needed to increase the dosage of GC, which led to rapid improvement. Furthermore, all patients proved very adherent to the therapies (assessed by Medication Adherence Rating Scale (MARS)) and considered this type of monitoring very satisfactory according to a Likert scale (mean score 4.4 ± 0.2 on a 1-5 range). Our study shows that telemedicine can be safely and effectively used in patients with GCA under control as a possible alternative, at least for a limited period of time, to traditional visits.

Synergies of feed, management trainings, and genetics on milk production of dairy cows in the tropics: The case of Ethiopian smallholder farmers

Efforts made so far to increase milk production of indigenous cattle by upgrading with exotic genotypes through crossbreeding under smallholder farmer conditions in Ethiopia have resulted in limited improvement. This study was conducted to determine if combining improved feed and management-related trainings with Holstein genetics will synergistically increase the milk production of dairy cows, and to examine the degree to which the increase or improvement is related to the level of exotic genetics involved. A total of 96 smallholder dairy farmers were purposively selected and allocated to one of three treatments reflecting differing degrees of capacity building support: (1) no training and no material support (Control); (2) training provided by another project (PAID) but without material support; (3) enhanced training plus material support (Feed-Mgt). Sixteen extension development agents and eight livestock experts were selected to provide training and weekly on-farm data collection, monitoring, technical support, and messaging reinforcement visits. Enhanced training addressed a broad range of topics related to feed and feeding, improved forage production, milk production and handling, construction and use of improved dairy housing, disease control, and dairy farm record keeping. Material support was in the form of formulated dairy concentrate feed and improved forage planting materials (seeds/seedlings). Data collection included variables describing animal performance, management practice adoption, and milk and butter quality. Tail hair samples for genetic profiling of breed makeup were also collected from all cows in the study. Results showed that there was a very significant effect of treatment (P &amp;lt; 0.001) on milk production, as well as treatment by week interaction (P = 0.034), with the effect of treatment markedly increasing over time (P = 0.032). That is, cows in Feed-Mgt group had up to 26.6% greater milk production compared to those in the Control group. Region and region by treatment interaction have no effects. Cows used in the experiment had varying proportions of Holstein-Friesian genome that ranged between 0 and 100%, suggesting prevalence of indiscriminate crossbreeding. Cows with a high proportion of Holstein genetics in treatment 3 produced more milk as compared to those in control group. Besides, supplemental feed improved body condition, reduced number of services per conception and resulted in higher lactation length of cows on treatment 3 compared with those on treatments 1 and 2 (P &amp;lt; 0.001). Overall, our findings suggest that an integrated approach of improved feed, feeding practices, and management training for smallholder dairy that goes beyond the improvement of genetics will increase milk production, improve milk quality and body condition, and resulted in higher length of lactation.

COVID-19 Vaccination Status and Operative Outcomes after Kidney Transplantation.

Kidney transplantation remains the best available treatment for end-stage renal disease. However, promoting graft longevity and preventing allosensitization requires strict adherence with a stringent immunosuppression regimen. The COVID-19 pandemic has offered new challenges for kidney transplant patients and many transplant centers are denying transplantation to unvaccinated patients. The aim of this study was to evaluate whether unvaccinated patients had inferior adherence after kidney transplantation along with a reduction in graft survival. Patients undergoing a deceased donor kidney transplantation at a single academic medical center from February 2021 to May 2022 were retrospectively reviewed. February 2021 was chosen as the start date for record review because it was 3 months after the first COVID-19 vaccination was authorized for emergency use. Patients were considered to be vaccinated if they received at least 1 dose of any mRNA vaccine by their transplantation date. Of the 301 patients who met study criteria, 234 were vaccinated and 67 were unvaccinated. Cohorts stratified by vaccination status were well matched. Younger age was an independent risk factor for nonvaccination. Interestingly, unvaccinated patients had worse postoperative adherence with a greater average number of missed postoperative clinic visits (p = 0.03) and a strong trend toward missing 3 or more postoperative clinic visits (p = 0.07). Finally, unvaccinated patients had statistically more subtherapeutic tacrolimus troughs (p = 0.01). Patients not vaccinated against COVID-19 had higher rate of postoperative nonadherence in key areas of immunosuppression monitoring and clinic visit attendance. Providers should be cognizant that an unvaccinated status may be a harbinger for poor adherence; therefore, stricter strategies for patient outreach are critical to ensure graft success in this vulnerable patient population.