Complete Adherence Research Articles

Impact of interdisciplinary sarcoma board evaluation on treatment outcome of primary soft-tissue sarcoma patients.

e23540 Background: Early presentation of soft-tissue sarcoma (STS) patients to a specialized sarcoma center including discussion in the interdisciplinary sarcoma board (ISB) prior to surgery is essential to the treatment of sarcomas. This approach significantly improves patient survival and guideline coherence. However, there exists only limited information on the adherence to the recommendations of the ISB. Accordingly, we decided to analyze a STS cohort at a large German sarcoma center focusing on outcome parameters and adherence to quality parameters defined by the German Cancer Society (Deutsche Krebsgesellschaft). Methods: In a retrospective data analysis, we identified n = 230 adult patients presented at the ISB of the Charité–Universitätsmedizin Berlin in Germany from January 2015 until December 2019. Inclusion criteria were as follows: newly diagnosed STS, presentation during first-line therapy and recommendation of at least one treatment modality such as surgery, chemotherapy, radiotherapy, regional hyperthermia or follow-up by the ISB. Clinical and follow up data was collected by using the hospital information system and the outpatient network. Results: Our patient cohort included 53% male and 47% female patients with a median age of 58 years (range 19-96). The majority (86%) showed a localized tumor stage, while 14% already had metastases. In 24% of the cases the sarcomas were classified as low-grade, in 76% as high-grade. Surgery was recommended for 66% of the cases, for 80% of them combined with chemotherapy, radiotherapy or hyperthermia. 14% of the patients received a recommendation for all 4 modalities. For 9% of the patients, chemotherapy alone was recommended. Both overall survival and progression-free survival was significantly higher in the group with complete adherence to the recommendations of the ISB (p < 0.001). The worst prognosis was found in patients unable to adhere to the recommendations due to rapid progression or complications of the therapy (HR for death 15.06, 95%CI 7.94-32.22). If one recommended modality was not carried out, there also was a higher risk of death (HR 4.38, 95%CI 1.75-10.96). Most common reasons were patient refusal or individual decision by the treating physician. A metastasized tumor stage was associated with an increased risk of death (HR 2.62, 95%CI 1.45-4.75). In contrast, neither the histological grading (low vs. high) nor age did influence the mortality significantly. Conclusions: In our cohort of STS patients, survival depends significantly on adherence to the recommendations of the ISB. Our analysis at a German sarcoma center is in line with previous international reports demonstrating the importance of interdisciplinary decisions and therapeutic adherence. We hereby underline the essential role of interdisciplinary approaches in care of STS patients and the effort to implement defined quality parameters.

What is the Optimal Method Assessing for Persistent Villous Atrophy in Adult Coeliac Disease?

Methods of assessing gluten-free diet (GFD) adherence in adults with coeliac disease (CD) include serological testing, dietitian evaluation, questionnaires and repeat duodenal biopsies. Persisting villous atrophy (VA) is associated with CD complications, however gastroscopy with biopsies is expensive and invasive. This study aimed to assess the abilities of a duodenal bulb (D1) biopsy and the Celiac Dietary Adherence Test (CDAT) to detect persisting VA in adults with CD. A prospective observational study of adult CD patients referred for follow-up duodenal biopsies was performed. Quadrantic biopsies were taken from the second part of the duodenum (D2), in addition to a D1 biopsy. Patients underwent follow-up serological testing, and completed the CDAT and Biagi Score. These non-invasive adherence markers were compared against duodenal histology. 368 patients (mean age 51.0 years, 70.1% female) had D1 and D2 biopsies taken at follow-up gastroscopy. Compared to D2 biopsies alone, additional D1 biopsies increased detection of VA by 10.4% (p<0.0001). 201 patients (mean age 50.3 years, 67.7% female) completed adherence questionnaires and serology. When detecting VA, sensitivities and specificities of these markers were 39.7% and 94.2% for IgA- tTG, 38.1% and 96.4% for IgA-EMA, 55.6% and 52.2% for CDAT and 20.6% and 96.4% for the Biagi score. Bulbar biopsies increase detection of persisting VA by 10.4%. Serology, CDAT and Biagi performed poorly when predicting VA. The gold standard for predicting persisting VA remains repeat biopsy.

Evaluation of the Sociodemographic, Behavioral and Clinical Influences on Complete Antiretroviral Therapy Adherence Among HIV-Infected Adults Receiving Medical Care in Houston, Texas.

IntroductionFew studies have estimated complete antiretroviral therapy (ART) adherence following HIV infection since the advent of the new ART guidelines in 2012. This study determined the prevalence and influence of sociodemographic, behavioral, and clinical factors on complete ART adherence among people living with HIV (PLWH) receiving medical care in Houston/Harris County, Texas.MethodsData from the Houston Medical Monitoring Project survey collected from 2009 to 2014 among 1073 participants were used in this study. The primary outcome evaluated was combined adherence, defined as complete, partial, and incomplete combined adherence based on three ART adherence types—dose, schedule, and instruction adherence. The duration living since initial HIV diagnosis was classified as <5, 5–10 and >10 years. Rao–Scott Chi-square test and multivariable proportional-odds cumulative logit regression models were employed to identify the sociodemographic, behavioral, and clinical characteristics of complete combined adherence among the three groups of PLWH living with HIV infection.ResultsMore than one-half (54.4%) of PLWH had complete, 37.4% had partial, and 8.3% had incomplete combined adherence. Among these PLWH, 52.2% had been infected with HIV for >10 years, and 26.5% and 21.4% were infected for <5 years and 5–10 years, respectively. PLWH who were diagnosed <5 and 5–10 years were two times (aOR=1.71, 95% CI=1.13–2.57; aOR=1.69, 95% CI=1.10–2.59; respectively) more likely to experience complete combined adherence than those with >10 years of infection. Multiple sociodemographic, behavioral, and clinical characteristics were significantly associated with complete adherence and varied by the duration of HIV infection.ConclusionMeasures of adherence should include all adherence types (dose, schedule, instruction), as utilizing a single adherence type will overestimate adherence level in PLWH receiving medical care. Intervention efforts to maintain adherence should target recently infected PLWH, while those aimed at improving adherence should focus on longer infected PLWH.

Reporting Quality of Cost-Effectiveness Analyses Conducted in Saudi Arabia: A Systematic Review

ObjectivesPharmacoeconomics and health economics in general is a new field that is still developing and emerging, not only in Saudi Arabia but all over the world. The objective of this study is to collect all published cost-effectiveness analysis (CEA) studies conducted based on Saudi settings and to evaluate their reporting quality. MethodsWe used PRISMA guidelines to search for all English-language CEAs conducted in Saudi Arabia in 3 databases: Medline, Embase, and Scopus. Keywords used in the search were: cost-effectiveness, cost-benefit, cost-utility, economic evaluation, Saudi Arabia. The data extracted were analyzed to assess reporting quality based on Consolidated Health Economic Evaluation Reporting Guidelines (CHEERS) and the second panel recommendations. ResultsThe 3 databases yielded 859 articles after removing duplicates. Only 7 articles included as final results following PRISMA guidelines. These 7 studies were published between 2015 and 2020. The CEA studies varied in their reporting quality; however, there were common missing required items among all of them, such as justifying choosing of a specific model and time horizon and reporting the ethical implications of the studied interventions. ConclusionSeven published CEA studies were conducted based on Saudi settings as revealed by this review. The included studies reported the more important aspects of CEA studies. However, there were missed reporting items based on the checklists we used to assess CEAs in this review. Although perfect and complete adherence to CHEERS or the second panel guidelines is a high standard, future CEAs should adhere to such standards. Transparency and good reporting are cornerstones in CEAs, and future CEAs should report their methods, findings, and results in a more transparent and efficient way.

Manejo extrahospitalario de la fibrilación auricular y su Adecuación a las guías de práctica clínica

Objetivo: Estudiar la variabilidad del manejo de la fibrilación auricular (FA) por equipos de emergencias y su adherencia a las guías de tratamiento. Material y método. Estudio descriptivo de episodios de FA atendidos en dos años en Cádiz. Recogemos 236 pacientes. Analizamos antecedentes, actuación del equipo y resultados de control de frecuencia y ritmo. Construimos un índice sintético de adecuación terapéutica (ISAT) con rango de -3 a 3. Resultados. 236 pacientes, 68% varones, las mujeres más jóvenes (66 vs 75 años); 43.8% fueron primeros episodios. El fármaco más usado es la amiodarona. El 16,1% de las asistencias presentaron adherencia completa (ISAT 3) y el 63,1%, adecuación parcial positiva (ISAT 1-2); la mayor variabilidad clínica se produjo en la bradicardización. La adecuación fue: 62,3% para anticoagulación, 68.2% para bradicardización y 56.8% para cardioversión. Existió un 40,7% de control de frecuencia y un 96% de derivación hospitalaria. Conclusión. Debemos aumentar el porcentaje de anticoagulación y empleo de bloqueadores-beta y calcioantagonistas en sustitución de amiodarona. El ISAT permite mejorar la adecuación a las GPC que facilita controlar síntomas, frecuencia y reducir estancias en los servicios de urgencia.

Negative impact of family religious and spiritual beliefs in schizophrenia – a 2 year follow-up case

IntroductionFor individuals with mental disorders and their families, religion and spirituality may have a significant influence over how these conditions are understood, managed and treated. Family can act as a moderator in which psychotic patients interpret and explain internalized events. However, they can have a negative impact when discouraging diagnosis and treatment adherence.ObjectivesExplore the impact of family religious and spiritual beliefs on clinical outcomes among a schizophrenic patient. Investigate the psychiatrist’s role in addressing barriers to treatment adherence.MethodsData retrieved from clinical interview. Subsequent non-systematic review of the most relevant literature on the topic.ResultsWe report a case of a 30-year-old single catholic woman, living with her parents. She had a past history of psychotic symptoms that were interpreted in a context of a depressive episode. After some months she fulfilled the criteria for Schizophrenia and anti-psychotic was prescribed. Family always demonstrated doubts about the disease and negatively influenced the treatment adherence. They believed she was possessed by demons and she was submitted to exorcisms and spiritual therapies. After a 2-year follow-up with erratic treatment regimens and worsening symptoms they accepted her hospitalisation. The majority of symptoms were controlled allowing complete adherence to the same treatment proposed before.ConclusionsThe disease acceptance is a complex process, influenced by multiple beliefs that play different roles in each patient and family, that can adversely influence clinical management. It is essential to understand the family sociocultural environment, by gauging the most influential elements aiming to enhance their compliance with treatment.DisclosureNo significant relationships.

Adherence to standard treatment guidelines among prescribers in primary healthcare facilities in the Dodoma region of Tanzania

BackgroundTanzania’s primary healthcare system suffers from a scarcity of financial and human resources that impedes its effectiveness to deliver dependable and uniform quality healthcare. Adherence to standard treatment guidelines (STG) can help provide more consistent and correct diagnoses and treatments and limit the irrational use of medicines and the negative health consequences that can occur as a result. The purpose of this study was to investigate prescribers’ adherence of their diagnoses and respective treatments to national STG and to identify potential areas for planning interventions.MethodsA cross-sectional study on prescribers’ adherence to diagnosis and treatment, according to national STG, was conducted in 2012 in public primary healthcare facilities (HCF) in the Dodoma region of Tanzania. Information on 2886 patients was collected, prospectively and retrospectively, from 120 HCF across the Dodoma region using a structured questionnaire. Twenty-five broadly defined main illness groups were recorded and the nine most prevalent and relevant conditions were statistically analysed in detail.ResultsDiagnoses and related treatments were recorded and analysed in 2872 cases. The nine most prevalent conditions were upper respiratory tract infections (25%), malaria (18%), diarrhoea (9.9%), pneumonia (6.1%), skin problems (5.8%), gastrointestinal diagnoses (5%), urinary tract infections (4%), worm infestations (3.6%) and eye problems (2.1%). Only 1.8% of all diagnoses were non-communicable diseases. The proportion of prescribers’ primary diagnoses that completely adhered to national STG was 599 (29.9%), those that partially adhered totalled 775 (38.7%), wrong medication was given in 621 cases (30.9%) and no diagnosis or medication was given in nine cases (0.5%). Sixty-one percent of all patients received an antibiotic regardless of the diagnoses. Complete adherence was highest when worms were diagnosed and lowest for diarrhoea. The proportion of cases that did not adhere to STG was highest with patients with skin problems and lowest for malaria.ConclusionPrescribers’ general adherence to national STG in primary HCF in the public sector in Dodoma region is sub-optimal. The reasons are multifaceted and focused attention, directed at improving prescribing and pharmacotherapy, is required with a view of improving patient care and health outcomes.

Urinary drug metabolite testing in chronic heart failure patients indicates high levels of adherence with life-prolonging therapies.

AimsDespite medical therapy for heart failure (HF) having proven benefits of improving quality of life and survival, many patients remain under‐treated. This may be due to a combination of under‐prescription by medical professionals and poor adherence from patients. In HF, as with many other chronic diseases, adherence to medication can deteriorate over time particularly when symptoms are well controlled. Therefore, detecting and addressing non‐adherence has a crucial role in the management of HF. Significant flaws and inaccuracies exist in the methods currently used to assess adherence such as patient reporting, pill counts, and pharmacy fill records. We aim to use high‐performance liquid chromatography–tandem mass spectrometry (HPLC‐MS) to detect metabolites of HF medications in the urine samples of chronic HF patients.Methods and resultsUrine samples were collected from 35 patients in a specialist HF clinic. Patients were included if they had an ejection fraction <45% and were taking at least two disease‐modifying HF medications. They were excluded if they had been admitted to hospital for HF in the 3 months preceding clinic attendance. These samples were sent for HPLC‐MS and tested for all HF medications prescribed for that patient. A high rate of complete adherence of 89% was detected in these patients, with 94% being partially adherent (at least one HF medication detected) to therapy (at least one HF medication detected). This analysis also highlighted that mineralocorticoid antagonists represent both the most under‐prescribed (67%) and poorly adhered (75%) medication class.ConclusionsThis analysis revealed a surprisingly high level of adherence to disease‐modifying therapy in chronic HF patients and highlights that most of our ‘total’ under‐treatment is likely to be from a failure to prescribe rather than a failure to adhere. Testing for metabolites of disease‐modifying HF drugs in urine using HPLC‐MS is feasible and is a useful adjunct to a specialist HF service. At present, the distinction between treatment failure and failure to take treatment is not always clear, which is important because the investigation and potential solutions are different. The former needs initiation of additional therapies and consideration of additional diagnoses, whereas the latter requires strategies to understand reasons underlying poor adherence and collaborative working to improve this: the wrong strategy will be ineffective.

A ‘case-mix’ approach to understand adherence trajectories for a falls prevention exercise intervention: A longitudinal cohort study

ObjectiveWe identified adherence-based case-mixes from participants’ longitudinal adherence to falls prevention exercise interventions over 12 months. Second, we identified modifiable baseline predictors (cognition, mobility and functional status) based on participants' case-mix adherence trajectories. Study design and outcome measuresThis study was a 12-month longitudinal secondary analysis of data from 172 participants who received the Otago Exercise Program (OEP) in a randomized controlled trial. Adherence to the OEP was ascertained monthly via self-report. Case-mixes, groups of individuals who followed similar adherence trajectories, were visually defined using 12-month longitudinal trajectories; we used latent class growth modeling. Baseline predictors of adherence were examined for the following categories: 1) cognition, 2) mobility and 3) functional status. ResultsFour distinct case-mixes were identified. The “non-adherent” case-mix (18 %) was distinguished by a non-adherent and decreasing adherence trajectory over time. The “low adherence” case-mix (45 %) did not have complete adherence or consistent adherence over the 12-month follow-up. The “moderate adherence” case-mix (27 %) was characterized by a stable (i.e., non-variable) adherence trajectory with a slightly increasing pattern at midpoint. The “high adherence” case-mix (10 %) demonstrated consistent and high adherence over the 12-month follow-up. For individuals with “moderate adherence”, the Digit Symbol Substitution Test (DSST) significantly predicted adherence (relative risk ratio (RRR) = 1.12 (0.95 CI: 1.0–1.26); p = 0.049). For individuals with “high adherence”, the Digits Forward minus Digits Backward (RRR = 0.43 (0.95 CI: 0.23−0.79); p = 0.002) and Instrumental Activities of Daily Living (RRR = 0.36 (0.95 CI: 0.16−0.81); p = 0.01) significantly predicted adherence. ConclusionsCognitive profile and activities of daily living at baseline may predict the longitudinal pattern of adherence.

Simulation-Based Assessment of the Impact of Non-Adherence on Endoxifen Target Attainment in Different Tamoxifen Dosing Strategies.

Tamoxifen is widely used in breast cancer treatment and minimum steady-state concentrations of its active metabolite endoxifen (CSS,min ENDX) above 5.97 ng/mL have been associated with favourable disease outcome. Yet, about 20% of patients do not reach target CSS,min ENDX applying conventional tamoxifen dosing. Moreover, 4–75% of patients are non-adherent, resulting in worse disease outcomes. Assuming complete adherence, we previously showed model-informed precision dosing (MIPD) to be superior to conventional and CYP2D6-guided dosing in minimising the proportion of patients with subtarget CSS,min ENDX. Given the high non-adherence rate in long-term tamoxifen therapy, this study investigated the impact of non-adherence on CSS,min ENDX target attainment in different dosing strategies. We show that MIPD allows to account for the expected level of non-adherence (here: up to 2 missed doses/week): increasing the MIPD target threshold from 5.97 ng/mL to 9 ng/mL (the lowest reported CSS,min ENDX in CYP2D6 normal metabolisers) as a safeguard resulted in the lowest interindividual variability and proportion of patients with subtarget CSS,min ENDX even in non-adherent patients. This is a significant improvement to conventional and CYP2D6-guided dosing. Adding a fixed increment to the originally selected dose is not recommended, since it inflates interindividual variability.

Poor quality of life and incomplete self-reported adherence predict second-line ART virological failure in resource-limited settings

ABSTRACT We evaluated health-related quality of life (QoL) and self-reported incomplete adherence as predictors of early second-line antiretroviral (ART) virological failure (VF). ACTG A5273 study participants completed the ACTG SF-21 measure which has 8 QoL domains. We used exact logistic regression to assess the association of QoL at baseline and week 4 with early VF adjusted for self-reported adherence. Of 500 individuals (51% women, median age 39 years) in this analysis, 79% and 75% self-reported complete adherence (no missing doses in the past month) at weeks 4 and 24, respectively. Early VF was experienced by 7% and more common among those who self-reported incomplete adherence. Participants with low week 4 QoL scores had higher rates of early VF than participants with high scores. After adjusting for self-reported adherence at week 4, VL and CD4 at baseline, cognitive functioning, pain and mental health domains were significantly associated with subsequent early VF. In this post-hoc analysis, poorer QoL adds to self-reported incomplete adherence after 4 weeks of second-line ART in predicting VF at week 24. Evaluation is needed to assess whether individuals with poorer QoL might be targeted for greater support to reduce risk of VF. Trial registration: ClinicalTrials.gov identifier: NCT01352715.

Does maternal tooth brushing-related sef-efficacy predict child's brushing adherence?

Dental plaque is a root cause of dental caries. Effective plaque control in young children can be achieved with twice-daily assisted tooth brushing. Self-efficacy relates to one's confidence in performing a task. Self-efficacy is shown to facilitate the behavior change in treatments for lifestyle diseases. The influence of maternal self-efficacy in children's oral health behaviors is less studied. The aim of this study is to evaluate an association between maternal tooth brushing-related self-efficacy (MTBSE) and child's brushing adherence. This cross-sectional study was conducted in schools and included 781 mother-child dyads with children between the age group of 2 and 6 years. Selected mothers were asked to complete the questionnaires on sociodemographic data, mother's oral health knowledge (MOHK), tooth-brushing practices, and MTBSE. Brushing adherence was evaluated as complete adherence if the child followed twice daily assisted brushing using the toothbrush and toothpaste. Nonparametric tests were used to compare the variables. Binary logistic regression was used to evaluate the predictors of brushing adherence. Complete brushing adherence (assisted brushing with toothbrush and toothpaste at least twice per day) was seen only in 26.9% children. More children with complete brushing adherence were single children (P < 0.001). Children with complete brushing adherence had mothers with significantly higher MTBSE (P < 0.001). The presence/absence of siblings, MOHK, and MTBSE were found to be strong and significant predictors of brushing adherence in children. MTBSE plays a significant role in complete adherence to toothbrushing in children aged 2-6 years.

Clinical audit on diagnosis of ascites in infants and children in Assiut University Children Hospital

BackgroundAscites is pathologic fluid accumulation within the peritoneal cavity. The peritoneum generates a fluid that acts as a lubricant. It allows the abdominal organs to glide smoothly over one another. Ascites is that excess of this fluid that can build up between visceral and parietal layers.ObjectiveA clinical audit was done to assess the degree of adherence of medical physicians at Assiut University Children Hospital to protocols for diagnosis of ascites according to Tomar 2016 guidelines.Patients and methodsThe study included 60 infants and children admitted to Assiut University Children Hospital with ascites.ResultsThe study included 60 infants and children admitted to Assiut University Children Hospital with ascites during a period of 1 year. Overall, 33 cases were males and 27 cases were females. All studied cases presented with ascites at the time of diagnosis.ConclusionRegarding this initial audit about diagnosis of ascites in infants and children in Assiut University Children Hospital, there is no complete adherence to Tomar 2016 guidelines.

Ultrasound-guided injections of the equine head and neck: review and expert opinion.

Ultrasound-guided injections can be used for a wide variety of conditions in the horse, including both diagnostic and therapeutic applications. Benefits of ultrasound guidance include more accurate deposition of injectate compared with blind approaches. Improved identification of vital structures, including nerves and blood vessels, allows their avoidance and thus reduces procedure-associated complications. Validation of such ultrasound-guided techniques has shown that they can be easily learnt by inexperienced veterinarians, assuming a proper knowledge of the sonographic anatomy. In many cases they can be employed in the field with a high level of accuracy, using widely available equipment, and with complete adherence to the sterility principles. Many ultrasound-guided injection techniques of the axial skeleton in the horse have been described in past years, enabling the equine veterinarian to perform more accurate treatments of specific anatomical areas. The goal of this review is to discuss diagnostic and therapeutic ultrasound-guided injection techniques of the skull and cervical spine in the horse, including those for the retrobulbar space, maxillary and inferior alveolar nerves, atlanto-occipital and atlanto-axial junctions, and cervical articular process joints, as well as the 1st cervical nerve, the C2 and C3 nerve plexus, and the 6th, 7th, and 8th cervical nerve roots.

A patient with heartburn practicing self-treatment, on an outpatient visit

More than 40% of adult Russians periodically feel heartburn. Progression of the disease leads to a number of complications shortening patients life. However, patients try to cope with problems by themselves, without receiving adequate early treatment. Only when the life quality worsens, which evidences progression of the disease, they turn to a doctor. Success of treatment depends on the level of the patients compliance, life-long complete and regular adherence to treatment recommended by the doctor. With this, an outpatient with a chronic disease should provide the most part of the required medical service by himself. However, patients often change the therapeutic measures on their own impairing the result of treatment.&#x0D; The given below clinical case of patient Zh., 38 years old, with heartburn and existing risk factors of other non-infectious diseases is a typical illustration of the interaction of a general practitioner and an outpatient practicing self-treatment. Facing the situation of necessary regular medical monitoring and life-long complex intervention, the patient uses only easy-to-follow doctors recommendations and understandable for him treatment methods.&#x0D; Conclusion. On an example of this clinical case, a possible necessary and sufficient plan o f informing outpatient is presented containing information of the tactics of his behavior for full realization of medical recommendations. For successful adaptation of an outpatient with chronic health problems and harmonic attitude to the disease, the doctor should be maximally specific about necessary and adequate measures for correction of the patients behavior for the fullest realization of therapeutic recommendations. Recommendations should contain understandable information of basic medicinal and non-medicinal therapy in remission (the essential vital stereotypes work-rest regime, type and regime of nutrition, physical activity and principles of monitoring the condition), of signs of exacerbation and methods of therapy on demand and also information of symptoms requiring urgent assistance, of risks of self-treatment, of visiting the doctor in case new or vivid symptoms appear, of the dates of planned examinations by the doctor. These recommendations are not applicable to patients with severe and manifest course of the disease, with disharmonic attitude to the disease, and in case of inadequate organization capacities and low compliance of the patient.

Creation of a novel inflatable vaginal stent for McIndoe vaginoplasty

To describe how to create an inflatable vaginal stent for use in McIndoe vaginoplasty that can be constructed using standard operating room supplies. Step-by-step video instructions that demonstrate how to construct and use an inflatable vaginal stent. (This video article was exempt from institutional review board approval.) SETTING: Academic hospital. A woman presenting with vaginal agenesis requiring a McIndoe vaginoplasty for the creation of a neovagina. A novel inflatable vaginal stent compliant with operating room procedures that is radio-opaque, functional, and can be used for patients with or without a functional uterus. The device is modeled after the effective inflatable vaginal stent that was previously commercially available but is no longer produced. Although a vaginal stent may be created in the operating room by placing surgical sponges inside a sterilized condom, many operating rooms have restrictions on equipment that can be brought into the operating room and special criteria for how to sterilize this equipment, and there are also restrictions against leaving non-radio-opaque objects "inside" the patient. The novel inflatable vaginal stent we have developed has multiple advantages compared with a rigid dilator: it is deflatable, so it does not cause trauma or interrupt the delicate tissue graft during insertion, removal, or repositioning; it is firm enough to conform and circumferentially press the tissue graft against the dissected vaginal space but is soft enough to decrease the risk of pressure necrosis or damage to the urethra; and it has a drainage port to prevent the buildup of a fluid pocket that could interfere with graft adherence. Our stent incorporates all these unique properties and can be easily constructed using sterile operating room supplies. The construction of this device requires a silicone Foley catheter, sterile foam sponges from a vaginal prep kit, a sterile radio-opaque sponge, a sterile vaginal ultrasound probe cover, a long Kelly, a 60-cc catheter tip syringe, a ruler, scissors, 0-vicryl suture, and sterile gloves. Effectiveness of a self-made inflatable vaginal stent using standard operating room supplies that meets operating room protocol standards. A standard dose of prophylactic antibiotics should be administered preoperatively to prevent surgical site infection. After placement of the tissue graft in the dissected neovagina cavity, the vaginal stent is placed and slowly inflated to circumferentially apply the tissue graft against the dissected vaginal space. The stent remains in place for 7 days and then should be removed in the operating room to allow for an examination under anesthesia, which provides the ideal setting to best evaluate the initial graft adherence. After careful inspection of the neovagina and tissue graft, a standard silicone vaginal mold is placed to maintain vaginal patency and prevent stricture of the tissue graft. The silicone mold should remain in place continuously until complete graft adherence occurs (approximately 4 to 6 weeks), and then it can be worn nightly until the patient is regularly sexually active. If at any point the patient discontinues nightly use of the silicone mold before regular sexual activity, vaginal stricture and a decrease in vaginal caliber will occur. Our novel inflatable vaginal stent is useful to surgeons performing a McIndoe vaginoplasty for vaginal agenesis with or without a uterus. It is compliant with operating room protocols and restrictions, as it is constructed from operating room supplies and is radio-opaque. Moreover, it is adjustable in size and effective in applying circumferential pressure for graft adherence. When used for segmental vaginal agenesis, the Foley catheter may be advanced through the cervix, then the balloon can be inflated, to stabilize the position of the stent during the first week postoperatively. The main limitation of this device is that it must be constructed by the surgeon, but the advantage of self-constructing the stent is that the size and shape can be tailored to conform to each individual patient. We prefer this inflatable vaginal stent to a rigid vaginal dilator in the first week of tissue healing to allow for easy insertion and removal of the stent without disrupting the tissue graft, to help prevent tissue necrosis, and to provide a fluid drainage port during graft adherence. We recommend this device as an ideal option for surgeons to consider when performing a McIndoe vaginoplasty.

Asthma Activity and Respiratory Morbidity in Children during the COVID-19 Pandemic: Results of a Retrospective Comparative Observational Study

Background. According to available studies during the pandemic, the incidence of COVID-19 among children was significantly lower than among adults. However, it remains unclear whether children with allergies and asthma are at risk for COVID-19 and whether the respiratory morbidity have changed during the pandemic in children with asthma as well as the asthma activity.&#x0D; Aims to determine the respiratory morbidity in children with and without asthma before and during the COVID-19 pandemic, to estimate asthma activity.&#x0D; Methods. The main group was formed of 60 children 617 y.o with confirmed asthma diagnosis, the control group from 30 children aged 617 y.o. without asthma. Data on outcomes in children with asthma and in control group were obtained on the basis of the retrospective collected information from medical records of patients and from questionnaires, filled during telephone call in 2020. Respiratory morbidity was estimated in 2019 and during the COVID-19 pandemic period in 2020 till the end of May.&#x0D; Results. The incidence of upper respiratory tract infections has decreased in 2020 in 72% of children with asthma by an average of 53%; in 86% of children without by an average of 62%. The frequency of lower respiratory tract infections decreased in 37% of children with asthma by an average of 61%, in 20% of children without asthma on 100%. According to the patients parents answers, none of the children were diagnosed with COVID-19. The number of episodes which required additional anti-asthma therapy decreased or didnt change in 77% of patients. According to the results of the Asthma Control Test in 2020 asthma was fully controlled in 82% of patients, 65% of patients had complete adherence to therapy.&#x0D; Conclusions. Children with asthma and allergies, as well as healthy children, do not seem to be at risk of contracting a new coronavirus infection. Lockdown, good adherence to therapy in children with asthma had a positive impact, led to a decrease of respiratory morbidity, exacerbations of asthma, improved disease control. Further monitoring of children with allergies and asthma during the COVID-19 pandemic is required.

Guideline adherence and long-term clinical outcomes in patients with acute myocardial infarction: a Japanese Registry of Acute Myocardial Infarction Diagnosed by Universal Definition (J-MINUET) substudy.

The association between guideline adherence and long-term outcomes in patients with acute myocardial infarction in real-world clinical practice remains unclear. We investigated 3283 consecutive patients with acute myocardial infarction who were selected from a prospective, nation-wide, multicentre registry (J-MINUET) database covering 28 institutions in Japan between July 2012 and March 2014. Among the 2757 eligible patients, we evaluated the use of seven guideline-recommended therapies, including urgent revascularisation, door-to-balloon time of 90 minutes or less, and five discharge medications (P2Y12 inhibitors on aspirin, beta-blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, statins, lipid-lowering drugs). The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, cardiac failure and urgent revascularisation for unstable angina up to 3 years. The overall median composite guideline adherence was 85.7%. Patients were divided into the following three groups: complete (100%) adherence group (n=862); moderate adherence (75% to <100%) group (n=911); and low adherence (0-75%) group (n=984). The rate of adverse cardiovascular events was significantly lower in the complete adherence group than in the low and moderate adherence groups (log rank P<0.0001). Multivariate Cox regression analysis showed complete guideline adherence was also significantly associated with lower adverse cardiovascular events compared with low guideline adherence (hazard ratio 0.66; 95% confidence interval 0.52-0.85; P=0.001). The use of guideline-based therapies for patients with acute myocardial infarction in contemporary clinical practice was associated with significant decreases in adverse long-term clinical outcomes. UMIN Unique trial Number: UMIN000010037.

Client Factors Affect Provider Adherence to Guidelines during First Antenatal Care in Public Health Facilities, Ethiopia: A Multi-Center Cross-Sectional Study.

Timely entry to an antenatal care with a healthcare provider who follows a set of national guidelines is assumed to ensure higher levels of client satisfaction. It is also expected to improve perinatal outcomes. Little is known about the level of adherence of Ethiopian providers to these guidelines. Therefore, this study aims to assess the proportion of clients who received complete (100%) provider adherence to antenatal care guidelines at the first visit and client associated factors in Gondar Town. A cross-sectional study of 834 study participants was conducted in public health facilities of Gondar Town in Ethiopia. An 18 point checklist was used to observe provider adherence to the first antenatal care visit guidelines. Descriptive statistics and multivariable binary logistic regression model were done by using STATA 14 software. The proportion of clients who received the complete provider's adherence to the first antenatal care guideline was 32.25% (95% CI: 29.1-35.5). The mean adherence score was 16.78%. Women who had prior history of pregnancy and/or birth-related complications (AOR = 1.58; 95%CI: 1.04-2.04) and late antenatal care booking at gestational week 16 or greater (AOR = 1.45; 95%CI: 1.03-2.03) were significantly associated with clients receiving complete providers' adherence to the first antenatal guideline. We found the level of adherence to national antenatal care guidelines during first visit as surprisingly low. When considering to upgrade the guidelines to the actual WHO guideline of eight visits, we recommend that refresher training be provided regularly to help staff understand the importance of following the guidelines as closely as possible. Perhaps, we need to learn more from the health care providers themselves about their reasons for not following the guidelines.

Poor attainment of blood pressure, lipids and diabetes targets in people at high cardiovascular risk in Europe: a report from the ESC-EORP EUROASPIRE V Survey in 16 European countries

Abstract Introduction The EUROASPIRE V survey in primary care was carried out by the European Society of Cardiology, EURObservational Research Programme in 2017–2018 and investigated the risk factor management in patients at high cardiovascular (CVD) risk in16 European countries. Purpose To provide an audit the implementation of the 2016 Joint European Societies' guidelines on CVD prevention in people at high risk of developing CVD in primary care and to see whether the practice of preventive cardiology had improved by comparison with the previous EUROASPIRE IV survey in 2014–2015. Methods All patients were free of coronary or other atherosclerotic diseasebut considered at high CVD risk since they had been started on blood pressure and/or lipid and/or glucose lowering treatments. They were interviewed and examined by means of standardized methods ≥6 months after the start of therapy. Results 2,759high CVD risk individuals (58% females), mean age 59 (SD 12) years, were interviewed and examined (participation rate 70%). The risk factor control was very poor, with less than half (47%) of patients on blood pressurelowering medication reaching the target of &amp;lt;140/90 mmHg (&amp;lt;140/85 mmHg in people with self-reported diabetes). Among treated dyslipidaemic patients only 47% attained LDL-cholesterol target of &amp;lt;2.6 mmol/L. Among treated type 2 diabetic patients, 65% achieved the HbA1c target of &amp;lt;7.0mmol/L. However, many patients on no antihypertensive or lipid-lowering medications had elevated blood pressure (43%) and elevated LDL-cholesterol (81%), respectively. The use of blood pressure lowering medication in people with hypertension was: ACE inhibitors/ARBs 79%, beta-blockers 37%, diuretics 36% and calcium channel blockers 32%; with 42% on one, 34% on two, 18% on three and 6% on ≥4 blood pressure lowering drugs. Among people on lipid-lowering medication, statins were prescribed in 97% and fibrates in 3%. Less than two-thirds of patients reported complete adherence with the intake of their blood pressure and lipid-lowering medications. The comparison with EUROASPIRE IV in the same centres that took part in both surveys showed no change in the BP management. There was a slight improvement in the control of LDL-cholesterol and glucose in patients with diabetes. Conclusions The results of EUROASPIRE V clearly demonstrate that the control of blood pressure, LDL-cholesterol and diabetes in patients at high CVD risk remains poor with large proportions not achieving the targets defined in the prevention guidelines. There is a considerable potential to raise the standards of preventive cardiology and to improve the management of patients at high CVD risk in Europe. Funding Acknowledgement Type of funding source: Other. Main funding source(s): European Society of Cardiology