Unscheduled Visits Research Articles

Study protocol of the CREDO randomised controlled trial: evaluation of a structured return home consultation for patients suffering from metastaticcancer

IntroductionPatients suffering from cancer are often managed by multiple health professionals. General practitioners with specific skills in oncology could facilitate care coordination between hospital and general practice in the management...

Upstreamist leaders: how risk factors for unscheduled return visits (URV) to the emergency department can inform integrated healthcare

PurposeThis paper aims to report on research undertaken in an National Health Service (NHS) emergency department in the north of England, UK, to identify which patients, with which clinical conditions are returning to the emergency department with an unscheduled return visit (URV) within seven days. This paper analyses the data in relation to the newly introduced Integrated Care Boards (ICBs). The continued upward increase in demand for emergency care services requires a new type of “upstreamist”, health system leader from the emergency department, who can report on URV data to influence the development of integrated care services to reduce further demand on the emergency department.Design/methodology/approachPatients were identified through the emergency department symphony data base and included patients with at least one return visit to emergency department (ED) within seven days. A sample of 1,000 index visits between 1 January 2019–31 October 2019 was chosen by simple random sampling technique through Excel. Out of 1,000, only 761 entries had complete data in all variables. A statistical analysis was undertaken using Poisson regression using NCSS statistical software. A review of the literature on integrated health care and its relationship with health systems leadership was undertaken to conceptualise a new type of “upstreamist” system leadership to advance the integration of health care.FindingsOut of all 83 variables regressed with statistical analysis, only 12 variables were statistically significant on multi-variable regression. The most statistically important factor were patients presenting with gynaecological disorders, whose relative rate ratio (RR) for early-URV was 43% holding the other variables constant. Eye problems were also statistically highly significant (RR = 41%) however, clinically both accounted for just 1% and 2% of the URV, respectively. The URV data combined with “upstreamist” system leadership from the ED is required as a critical mechanism to identify gaps and inform a rationale for integrated care models to lessen further demand on emergency services in the ED.Research limitations/implicationsAt a time of significant pressure for emergency departments, there needs to be a move towards more collaborative health system leadership with support from statistical analyses of the URV rate, which will continue to provide critical information to influence the development of integrated health and care services. This study identifies areas for further research, particularly for mixed methods studies to ascertain why patients with specific complaints return to the emergency department and if alternative pathways could be developed. The success of the Esther model in Sweden gives hope that patient-centred service development could create meaningful integrated health and care services.Practical implicationsThis research was a large-scale quantitative study drawing upon data from one hospital in the UK to identify risk factors for URV. This quality metric can generate important data to inform the development of integrated health and care services. Further research is required to review URV data for the whole of the NHS and with the new Integrated Health and Care Boards, there is a new impetus to push for this metric to provide robust data to prioritise the need to develop integrated services where there are gaps.Originality/valueTo the best of the authors’ knowledge, this is the first large-scale study of its kind to generate whole hospital data on risk factors for URVs to the emergency department. The URV is an important global quality metric and will continue to generate important data on those patients with specific complaints who return back to the emergency department. This is a critical time for the NHS and at the same time an important opportunity to develop “Esther” patient-centred approaches in the design of integrated health and care services.

Re-initiation of elective total knee arthroplasty with an adapted pathway during the 2020 COVID-19 pandemic was safe and effective.

In June 2020 when elective total knee arthroplasty (TKA) resumed after the initial COVID-19 surge, we adapted our TKA pathway focusing on a shorter hospitalization, increased home discharge, and use of post-discharge telemedicine and telerehabilitation. The purpose of this study was to evaluate if changes in postoperative care affected early TKA outcomes. Five hundred and fifty-four patients who underwent elective primary unilateral TKA for primary osteoarthritis between June and August 2020 (study group) were matched 1:1 for age, sex, body mass index, and Charlson comorbidity index with control patients who underwent surgery between August and November 2019. Study patients were discharged 25h earlier on average compared to controls, more frequently on the same-day or postoperative day-1 (24.9% vs. 16.1%; p = 0.001), and more frequently home (97.3% vs. 83.8%; p < 0.001). Study patients used telemedicine (11.7% vs. 0%; p < 0.001) and telerehabilitation (19.7% vs. 2.5%; p < 0.001) at higher rates than controls. Generalized estimating equations, Mann-Whitney U, and Chi-Square tests were used to compare outcomes between groups including unscheduled office visits, ER visits, readmissions, Center for Medicare and Medicaid Services (CMS) complications, manipulation under anesthesia (MUA), and patient-reported outcomes measures (PROMs). Rates of emergency room visits, readmissions, CMS complications, MUA, and improvements in PROMs were similar between cohorts. Study patients experienced higher rates of unscheduled outpatient visits (9.2% vs. 4.9%; p = 0.004), predominantly due to wound complications. A protocol implemented during the COVID-19 pandemic that leveraged a shortened hospitalization, higher rates of home discharge, and increased use of telemedicine and telerehabilitation was safe and effective.

Targeted amplicon deep sequencing of ama1 and mdr1 to track within-host P. falciparum diversity throughout treatment in a clinical drug trial.

Antimalarial therapeutic efficacy studies are routinely conducted in malaria-endemic countries to assess the effectiveness of antimalarial treatment strategies. Targeted amplicon sequencing (AmpSeq) uniquely identifies and quantifies genetically distinct parasites within an infection. In this study, AmpSeq of Plasmodium falciparum apical membrane antigen 1 ( ama1), and multidrug resistance gene 1 ( mdr1), were used to characterise the complexity of infection (COI) and drug-resistance genotypes, respectively. P. falciparum-positive samples were obtained from a triple artemisinin combination therapy clinical trial conducted in 30 children under 13 years of age between 2018 and 2019 in Kilifi, Kenya. Nine of the 30 participants presented with recurrent parasitemia from day 26 (624h) onwards. The ama1 and mdr1 genes were amplified and sequenced, while msp1, msp2 and glurp data were obtained from the original clinical study. The COI was comparable between ama1 and msp1, msp2 and glurp; overall, ama1 detected more microhaplotypes. Based on ama1, a stable number of microhaplotypes were detected throughout treatment until day 3. Additionally, a recrudescent infection was identified with an ama1 microhaplotype initially observed at 30h and later in an unscheduled follow-up visit. Using the relative frequencies of ama1 microhaplotypes and parasitemia, we identified a fast (<1h) and slow (>5h) clearing microhaplotype. As expected, only two mdr1 microhaplotypes (NF and NY) were identified based on the combination of amino acid polymorphisms at codons 86 and 184. This study highlights AmpSeq as a tool for highly-resolution tracking of parasite microhaplotypes throughout treatment and can detect variation in microhaplotype clearance estimates. AmpSeq can also identify slow-clearing microhaplotypes, a potential early sign of selection during treatment. Consequently, AmpSeq has the capability of improving the discriminatory power to distinguish recrudescences from reinfections accurately.

Unmet Need for Oral Corticosteroids Use and Exacerbations of Asthma in Primary Care in Taiwan.

Patients with asthma are treated in primary healthcare facilities (PHCFs) in Taiwan, where the asthma control status associated with acute exacerbation (AE) and use of oral corticosteroids (OCS) and short-acting β2-agonist (SABA) inhalers remains unclear. A cross-sectional, close-ended, face-to-face questionnaire survey invited board-certified physicians who treat adult asthma patients in PHCFs. The contents of the questionnaire included three parts: rescue OCS to treat AE, regular OCS for asthma control, and AE-related adverse outcomes. There were 445 out of 500 physicians who completed the questionnaire, with 61% of them being non-pulmonologists. A substantial proportion of asthma patients needed rescue OCS or regular OCS each month, or ≥3 canisters of SABA inhalers per year. Approximately 86% of physicians reported their patients with ≥2 AE-related unscheduled visits to clinics or emergency departments in the past year. A total of 41% of physicians reported their patients receiving intubation or intensive care in the past year. A total of 92% of physicians prescribed rescue OCS ≤ 40 mg/day. A total of 92% of physicians prescribed rescue OCS for a duration of ≤7 days for AEs. A total of 85% of physicians prescribed regular OCS ≤ 10 mg/day for asthma control. This is the first study to present the perceptions of asthma-treating physicians on the use of OCS in PHCFs. In summary, 31% of physicians reported ≥ 6% of their patients needed OCS for asthma control and 41% of physicians reported their patients with adverse outcomes in the past year. Thus, the need to improve asthma control in Taiwan is suggested by our study results.

Effect of School Integrated Pest Management or Classroom Air Filter Purifiers on Asthma Symptoms in Students With Active Asthma: A Randomized Clinical Study

To determine if environmental control measures (1) school-wide integrated pest management (IPM) program and/or (2) use of high-efficiency particulate air (HEPA) filter purifiers in inner city elementary school classrooms would reduce asthma morbidity in students with active asthma.Forty-one inner city elementary schools in the Northeastern United States were recruited for this study. There were 236 students with active, physician-diagnosed asthma randomized to IPM (by school) and/or HEPA filter purifiers (by classroom). Physician-diagnosed asthma was defined as the child having had unscheduled doctor visits, hospitalization, corticosteroid bursts, symptoms, or controller medication use in the past year. Fifty seven percent of the children were Hispanic and 24% were Black. Mean age was 8.1 years, 48% female, mean FEV1 97% to 99.7% predicted at randomization. Forty-fifty percent of the children were using short acting β agonists alone and the rest were on inhaled corticosteroids and/or leukotriene modifiers. The study was conducted during the school years 2015 to 2020.All students with active physician-diagnosed asthma had a screening visit with questionnaires, skin testing, and spirometry as well as 2 follow-up visits with the same assessments during the year. Baseline environmental assessment for a panel of allergens (mouse, rat, dust mite, cockroach, cat, dog, Alternaria alternate, and Aspergillus fumigatus) were conducted at the schools by collecting a 1-week air sample, immediately followed by vacuum–settled dust samples from each students’ primary classroom and in the participants homes. The allergens were analyzed using a multiplex assay (MARIA, Indoor Biotechnologies). Follow-up environmental assessment after randomization took place once each winter and spring during the school year.The allocation to free standing classroom HEPA filter purifiers, active or sham, was blinded to the participants and those assessing the outcomes. The IPM program consisted of application of rodenticide, sealing entry points, trap placement, targeted cleaning, and brief educational handouts for the school staff. Infestation was assessed every 3 months and IPM reapplied as needed. Trained pest management specialists providing the school-wide IPM program were unblinded, but the student participants and trial investigators remained blinded throughout the trial.Four groups of 59 students each were randomized using a factorial design to either intervention alone, both interventions together, or neither for the entire school year. Classroom and home allergen and particle levels at randomization were balanced between the 4 groups.The asthma-related health outcomes of the students were assessed by parent survey at baseline and every 2 months until the end of the school year. The primary outcome was the number of symptom-days with asthma during a 2-week period assessed over the 10 months of randomization. Prespecified secondary outcomes were school absences, Composite Asthma Severity Index score, healthcare utilization, and spirometry measurements.Ninety eight percent of the classrooms had detectable levels of mouse allergen and 26% of the participants were sensitized to mouse allergen. More than 90% of baseline classroom allergen levels for cockroach, rat, Alternaria, Aspergillus and dust mite were undetectable.Use of the school-wide IPM program resulted in a mean of 1.5 symptom-days with asthma during a 2-week period versus 1.9 symptom-days for no IPM; use of HEPA filter purifiers resulted in a mean of 1.6 symptom-days with asthma versus 1.8 symptom-days for sham HEPA filter purifiers; neither comparison was statistically significant. Other prespecified secondary outcomes, including healthcare utilization or missed school days because of asthma also did not differ significantly between the intervention groups. The HEPA filter purifiers significantly reduced mouse and dog allergens in the classrooms. The IPM program did not significantly reduce concentrations of any of the allergens or particles measured. A post hoc exploratory analysis found a statistically significant association of reduction in asthma symptoms with the school wide IPM program but only for a limited time (mid-November to February).In an inner-city population of elementary school students with active asthma, use of a school-wide IPM program or HEPA filter purifiers in the classrooms did not significantly reduce symptom-days with asthma.It is possible that these children had asthma that was too mild to see a significant difference in these environmental interventions. Also unclear is whether resources to perform environmental control measures are best used at the school level or at home. As an accompanying editorial notes, “as allergen sensitization is related to the pathogenesis and pathophysiology of childhood asthma,” allergen avoidance should still be a basic tenet of treatment and worth continued investigation.URL: www.pediatrics.org/cgi/doi/10.1542/peds.10.1001/jama.2021.11559

Adherence to treatment guidelines and good asthma control in Finland

ABSTRACT Background Asthma program in Finland decreased asthma-related mortality and expenses of care on national level, but there is lack of data on adherence to treatment guidelines and disease control on individual level. We aimed to assess adherence to guidelines and disease control among Finnish adult asthmatics. Methods Questionnaires were sent in Finland to 2000 randomly selected recipients aged 18–80 years, who had bought medication for obstructive airways disease during the previous 12 months. The questionnaire included questions on asthma medication, exacerbations, self-management and follow-up. Asthma symptom control was assessed by the Asthma Control Test (ACT). Results A high proportion (82.4%) of the 541 responders with physician-diagnosed asthma reported regular use of asthma medication and 97.1% of them used inhaled corticosteroids. Almost all (97.0%) of the asthmatics were taught how to use their inhaler and 78.4% had an asthma self-management plan, but only 35.7% reported regular annual follow-up visits. According to symptoms, 60.0% had their asthma well-controlled (ACT score ≥20). On the other hand, 29.2% had a course of oral corticosteroid and 21.8% had an asthma-related unscheduled health care visit during the previous year, but only 2.6% reported a hospitalization. Asthma control was better in those not using regular asthma medication. Conclusions The guidelines are well adopted in Finnish adult asthma care except for regular follow-up visits. Majority of patients had good symptom control and hospitalizations were rare. Better asthma control among those not using regular asthma medication implies they are not undertreated but have a mild disease.

Obesity in pregnancy in a resource-constrained setting: Complications and cost implications - a retrospective cross-sectional study.

To investigate the complications and costs associated with managing obese pregnant women in a resource-constrained environment. The files were randomly sampled for women that delivered at the tertiary level public sector Greys Hospital in Pietermaritzburg, South Africa; of the retrieved files, 206 met the inclusion criteria (January-June 2020). Patients were stratified by body mass index (normal, overweight, obese). The main outcomes being the prevalence of obesity, we conducted a logistic regression to compare the incidence of associated obstetric complications, and a direct costs comparison. Of the 206 patients, 117 (57%) were obese and at higher risk for fetal and maternal adverse outcomes. The obese/overweight group had higher incidence of pre-pregnancy complications; history of macrosomia and obstetric complications; and increased risk of failed induction, fetal anomalies, unscheduled prenatal care visits, and postpartum hemorrhage. Neonates born to obese/overweight women were at increased need for neonatal unit admission. The mean cost estimates were 49575.3 South African Rand (ZAR) for normal weight, 49310.5 ZAR for overweight, and 54444.2 ZAR for obese women. The high levels of obesity were associated with feto-maternal complications; the association increased healthcare use, resulting in a substantial increase in direct cost to the healthcare system.

TRial to Assess Implementation of New research in a primary care Setting (TRAINS): study protocol for a pragmatic cluster randomised controlled trial of an educational intervention to promote asthma prescription uptake in general practitioner practices

BackgroundThere is a marked increase in unscheduled care visits in school-aged children with asthma after returning to school in September. This is potentially associated with children not taking their asthma preventer medication during the school summer holidays. A cluster randomised controlled trial (PLEASANT) was undertaken with 1279 school-age children in 141 general practices (71 on intervention and 70 on control) in England and Wales. It found that a simple letter sent from the family doctor during the school holidays to a parent with a child with asthma, informing them of the importance of taking asthma preventer medication during the summer relatively increased prescriptions by 30% in August and reduced medical contacts in the period September to December. Also, it is estimated there was a cost-saving of £36.07 per patient over the year. We aim to conduct a randomised trial to assess if informing GP practices of an evidence-based intervention improves the implementation of that intervention.Methods/designThe TRAINS study—TRial to Assess Implementation of New research in a primary care Setting—is a pragmatic cluster randomised implementation trial using routine data. A total of 1389 general practitioner (GP) practices in England will be included into the trial; 694 GP practices will be randomised to the intervention group and 695 control group of usual care. The Clinical Practice Research Datalink (CPRD) will send the intervention and obtain all data for the study, including prescription and primary care contacts data. The intervention will be sent in June 2021 by postal and email to the asthma lead and/or practice manager. The intervention is a letter to GPs informing them of the PLEASANT study findings with recommendations. It will come with an information leaflet about PLEASANT and a suggested reminder letter and SMS text template.DiscussionThe trial will assess if informing GP practices of the PLEASANT trial results will increase prescription uptake before the start of the school year. The hope is that the intervention will increase the implementation of PLEASANT work and then increase prescription uptake during the summer holiday prior to the start of school.Trial registrationClinicalTrials.gov ID: NCT05226091

BAX 335 Hemophilia B Gene Therapy Phase 1/2 Clinical Trial: Long-Term Safety and Efficacy Follow-up

Background: BAX 335 is an adeno-associated virus serotype 8 (AAV8)-based clotting factor IX (FIX) Padua (R338L) gene therapy for the treatment of hemophilia B. A phase 1/2 safety and efficacy study dosed 8 participants with BAX 335 between 2013 and 2015 (NCT01687608). Infusions with BAX 335 were generally well tolerated; however, 7 of 8 participants did not achieve significant levels of durable transgene expression despite the use of glucocorticoids and resumed FIX replacement by 52 weeks (Konkle et al, Blood 2021;137:763-74). A root-cause analysis identified CpG content in the vector as a potential immunogenic trigger for the innate immune response, resulting in loss of expression. One participant demonstrated high levels of durable FIX expression, with detectable FIX activity levels between 0.1 and 0.4 IU/mL after 4 years and was found to have a missense variant in the IL6R gene. This study is the longest ongoing clinical gene therapy trial using a FIX R338L transgene. Aims: (1) To report long-term safety and participant disposition; (2) to describe persistence of endogenous FIX R338L transgene expression; and (3) to report long term persistence of neutralizing anti-capsid antibodies. Methods: Eight adult male participants with hemophilia B (FIX activity ≤2%) received BAX 335 in 1 of 3 intravenous dose cohorts (2.0 x 1011, 1.0 x 1012, or 3.0 x 1012 vector genomes/kg). The primary study objective was to assess the safety of BAX 335. Secondary assessments included the kinetics of plasma FIX activity, the need for exogenous FIX replacement, and systemic immune responses to BAX 335 and vector transgene protein. FIX clotting activity was measured using the one-stage clotting assay at the central laboratory. Serum neutralizing antibodies against the AAV8 and AAV2 capsids were measured to Year 5 following BAX 335 infusion using an in vitro transduction inhibition assay. Laboratory and in-person assessments were conducted for the first 5 years after BAX 335 infusion (one unscheduled visit was made at 7.2 Years). This was followed by annual liver ultrasound scans and telephone questionnaires assessing health status with the aim of completing 15 years of follow-up per participant. The study was approved by the institutional review boards of all participating sites, and all participants provided written informed consent. Results: Of 8 participants enrolled (aged 20-69 years), 2 discontinued from the study approximately 1 and 3 years after receiving BAX 335 infusion, and another participant withdrew consent 2 weeks prior to the data cutoff of May 6, 2022. Data from the 6 participants who had >5 years of long-term safety follow-up were included in this analysis. At data cutoff, 176 adverse events (AEs) were reported in all 8 dosed participants, most (72%) occurred in Years 1 and 2. In total, 6 serious adverse events (SAEs) were reported in 3 participants, of these 2 SAEs (post-procedural hemorrhage, arthritis) were reported after the interim analysis reported by Konkle et al. 2021. None were considered to be related to BAX 335 and all resolved. Although long-term hemostatic protection from bleeds was not observed in most of the participants in this analysis, 1 participant had continued FIX activity (Figure 1), with a most recent value of 0.078 IU/mL at 7.2 years after BAX 335 infusion. This participant has neither experienced any bleeds nor needed FIX replacement therapy after the second week of vector infusion. No FIX inhibitors have been observed. At Year 5, AAV neutralizing antibodies persisted at high titers in most participants (reciprocal of serum dilution: AAV2, <5 to 10,240; AAV8, 80 to 40,960). Conclusions: No additional BAX 335-related AEs, malignancy or thrombosis were reported in this long-term follow-up analysis of a phase 1/2 study. One participant achieved persistent FIX transgene activity in the circulation for 7.2 years and remains free from bleeding and the need for FIX replacement therapy. This is the longest duration of FIX R338L expression reported. Consistent with other studies, AAV neutralizing antibodies remained persistent at titers that would limit re-dosing with current AAV platforms. Future studies should explore patient-specific factors that may predict persistent transgene expression. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Evaluation of telehealth support in an integrated respiratory clinic

Supporting self-management is key in improving disease control, with technology increasingly utilised. We hypothesised the addition of telehealth support following assessment in an integrated respiratory clinic could reduce unscheduled healthcare visits in patients with asthma and COPD. Following treatment optimisation, exacerbation-prone participants or those with difficulty in self-management were offered telehealth support. This comprised automated twice-weekly telephone calls, with a specialist nurse triaging alerts. We performed a matched cohort study assessing additional benefits of the telehealth service, matching by: confirmed diagnosis, age, sex, FEV1 percent predicted, smoking status and ≥1 exacerbation in the last year. Thirty-four telehealth participants were matched to twenty-nine control participants. The telehealth cohort generated 165 alerts, with 29 participants raising at least one alert; 88 (53.5%) alerts received a call discussing self-management, of which 35 (21%) received definitive advice that may otherwise have required an unscheduled healthcare visit. There was a greater reduction in median exacerbation rate across both telehealth groups at 6 months post-intervention (1 to 0, p < 0.001) but not in control groups (0.5 to 0.0, p = 0.121). Similarly, there was a significant reduction in unscheduled GP visits across the telehealth groups (1.5 to 0.0, p < 0.001), but not the control groups (0.5 to 0.0, p = 0.115). These reductions led to cost-savings across all groups, but greater in the telehealth cohorts. The addition of telehealth support to exacerbation-prone patients with asthma or COPD, following comprehensive assessment and treatment optimisation, proved beneficial in reducing exacerbation frequency and unscheduled healthcare visits and thus leads to significant cost-savings for the NHS.Clinical Trial Registration: ClinicalTrials.gov: NCT03096509

Outpatient laparoscopic sacrocolpopexy: Feasibility and patient satisfaction

Study objectiveTo assess the feasibility and patient satisfaction of outpatient management of laparoscopic sacrocolpopexy. DesignObservational study. SettingMulticentric study in four French centers: La Conception University Hospital, Marseille; Simone Veil Hospital, Cannes; Simone Veil Hospital, Eaubonne; and Jules Verne Clinic, Nantes. PatientsA total of 125 patients required laparoscopic sacrocolpopexy and accepted outpatient surgery. InterventionsAssessment of outpatient surgery success, patient satisfaction, and self-evaluated symptom improvement after surgery. Measurements and main resultsDuring the study period, 574 patients required laparoscopic sacrocolpopexy, and 21.8% (125) of them met the inclusion criteria for outpatient surgery. The success rate for outpatient surgery was 95.2% (119/125). The perioperative complication rate was 4% (5/125). Among the successfully discharged outpatients, 2.5% (3/119) of them had an unscheduled visit within seven days. Among the discharged patients, 84% (105/125) answered the satisfaction questionnaire, and 88.5% (93/105) declared themselves as “satisfied” or “very satisfied” with the procedures. Patients who declared their conditions to have been “very improved” or “improved” compared to their preoperative symptomatology were 76.9% (83/108) of cases. ConclusionA high success rate for outpatient laparoscopic sacrocolpopexy associated with a high satisfaction rate were found in our study. The development of outpatient options for laparoscopic sacrocolpopexy was supported by our data.

P134 Sleep Laboratory contact in adults commencing CPAP: a post-hoc analysis of the AHEAD trial

Abstract Background CPAP used for &amp;gt;4hrs/night effectively treats obstructive sleep apnoea(OSA), however CPAP adherence is often poor. A randomised control trial from our department demonstrated improved CPAP adherence at 12 months in patients receiving video education (VE), compared with standard of care education (SOCE) at CPAP commencement. This follow-on study aimed to evaluate 12-month clinic utilisation of patients in the AHEAD trial, hypothesizing that increased unscheduled contact by patients in the intervention arm may contribute to improved CPAP adherence. Methods Post-hoc analysis of data from the AHEAD trial was performed. The AHEAD trial included 195 patients recruited from a large trial protocol and randomised to either SOCE or SOCE+VE. Demographics including age, gender, education level and socioeconomic indices were collected. CPAP usage was assessed at 2-, 6-, and 12-months post randomisation. Adequate adherence was defined as usage &amp;gt;4hours/night. Further data on number of scheduled and unscheduled visits at 12-months post randomisation was collected. The primary outcome was number of unscheduled visits in intervention vs control arm. Progress to date Study groups were well-matched at baseline. The proportion with adequate CPAP usage at 12mths was higher in the VE group (33, 33% versus 48, 50% p=0.01). Preliminary analysis suggests there are no significant differences in number of unscheduled visits at 12-month follow up between SOCE vs SOCE+VE (mean0.29 vs 0.43 p=0.18). Further analysis will investigate predetermined subgroups – including low educational level / socioeconomic status. Intended outcome and impact This study will inform strategies to improve CPAP adherence in patients with OSA.

Abstract 13145: Mixed Digital Model of Care in Real-Time for Mexican Patients With Heart Failure

Introduction Decompensated heart failure (DHF) is the main cause of cardiovascular hospitalization. During 1-year follow-up (FU), at least one rehospitalization occurred in 56.6% of patients with HF. In Mexico, HF places great burden on patients, caregivers, and healthcare systems. New strategies are essential for early diagnosis and treatment of DHF. Hypothesis: Use of a digital tool is effective for remote monitoring of patients with CHF to reduce the number of hospitalizations and/or unscheduled visits to the ER. Methods: A mixed digital model of HF (MDM-HF) care has been developed. It included an app in patient’s mobiles (CardioEnlace) that allowed real time monitoring of key parameters. These data were transferred into HF Unit portal and integrated into the patient's clinical file. CardioEnlace allowed detection of decompensation events through 1) alerts by patient′s text messages and 2) system alerts when variables were out of security limits on three or more consecutive days. If a patient showed signs of DHF, he/she was reached to provide medical instructions and/or scheduled an early appointment. Results: MDM-HF care was deployed in July 2021. Up to date 131 patients have been included. The median of age is 58 years (interquartile range 47.5-65.5) and 77.1% were male. Cardiovascular risk factors (CVRF) frequencies are shown in Table 1. HF was secondary to ischemic condition in 44.5% of the patients. At least one hospitalization in the previous 2 years was reported in 73.5% of the subjects. Cardio Enlace parameters are shown in Fig 1. A blood pressure &lt;140/90 mmHg was reported in 89.5% of patients and the average exercise time was 32 min/day. CardioEnlace alerts from January 2022 to date, were 82. Reasons are shown in Table 2. Adjustments to the treatment were done immediately and none of the patients had been hospitalized. Discussion: MDM-HF care model supports an early detection of DHF and monitorization of CVRF treatment which affect around 50% of the patients. Follow-up evaluations would allow to assess its impact on hospitalizations/emergency admissions. MDM-HF care model is part of the HF National Mexican Registry that will integrate data-driven solutions to reduce lead times from diagnosis to therapy adjustments and reduce the economic burden of DHF.

Efficacy of Nasal High-Flow Oxygen Therapy in Chronic Obstructive Pulmonary Disease Patients in Long-Term Oxygen and Nocturnal Non-Invasive Ventilation during Exercise Training.

High-flow oxygen therapy (HFOT) improves gas exchange and dead space washout and reduces the level of work required for breathing. This study aimed to evaluate pulmonary rehabilitation (PR) combined with HFOT in COPD patients treated with nocturnal non-invasive ventilation (NIV) and long-term oxygen therapy (LTOT). In particular, we sought to discover whether the addition of HFOT during exercise training could improve patients’ performance, mainly with regard to their Six-Minute Walking Test (6MWT) outcomes, and reduce the exacerbation rates, periods of rehospitalization or need to resort to unscheduled visits. Thirty-one COPD subjects (13 female) who used nocturnal NIV were included in a randomized controlled trial and allocated to one of two groups: the experimental group (EG), with 15 subjects, subjected to PR with HFOT; and the control group (CG), with 16 subjects, subjected to PR without HFOT. The primary outcome of the study was the observation of changes in the 6MWT. The secondary outcome of the study was related to the rate of exacerbation and hospitalization. Data were collected at baseline and after one, two and three cycles of cycle-ergometer exercise training performed in 20 supervised sessions of 40 min thrice per week, with a washout period of 3 months between each rehabilitation cycle. Statistical significance was not found for the 6MWT distance (W = 0.974; p = 0.672) at the last follow-up, but statistical significance was found for the Borg scale in regard to dyspnea (W = 2.50; p < 0.001) and fatigue (W = 2.00; p < 0.001). HFOT may offer a positive option for dyspnea-affected COPD patients in the context of LTOT and nocturnal NIV.

Elimination of Postoperative Narcotics in Infant Robotic Pyeloplasty Using Caudal Anesthesia and a Non-Narcotic Pain Pathway.

Introduction: Research suggests that narcotic pain medications are dramatically overprescribed. We hypothesize that narcotics are unnecessary for postoperative pain control in most infants undergoing robotic pyeloplasty. In this series, we report our experience combining caudal blocks with a non-narcotic postoperative pathway as a means of eliminating postoperative narcotics after infant robotic pyeloplasty. Methods: We reviewed 24 consecutive patients who underwent robotic pyeloplasty by a single surgeon treated with an end-procedure caudal block followed by a non-narcotic postoperative pain pathway treated between May 2017 and May 2021. The standardized postoperative pathway consisted of an end-procedure caudal block followed by alternating intravenous acetaminophen and ketorolac. We reviewed demographics, outcomes, and unscheduled health care encounters within 30 postoperative days. Results: Sixty-three percent (15/24) of patients were male and average age was 12.1 months (range 4-34 months). Fifty-eight percent (9/15) underwent surgery on the left, and 16.7% (4/24) of patients received a single postoperative dose of narcotics in the postanesthesia care unit. No patient required narcotic prescriptions at discharge or anytime thereafter. The average length of stay was 1.13 days. There was no pain-related unscheduled visits or phone calls after discharge. Conclusions: This series shows that a non-narcotic standardized pain management strategy is a viable option for infants undergoing robotic pyeloplasty. Postprocedure caudal block is a good addition to a non-narcotic pathway. In the future, we intend to expand these findings to other pediatric urologic procedures in the hope of eliminating unnecessary narcotic use.

Laparoscopic right colectomies with intracorporeal compared to extracorporeal anastomotic techniques are associated with reduced post-operative incisional hernias.

BackgroundOwing to important differences in surgical technique, laparoscopic right colectomy with intracorporeal (ICA) compared to extracorporeal (ECA) anastomotic technique may result in improved patient outcomes. We aimed to compare both techniques according to incisional hernias and other pertinent perioperative characteristics, post-operative complications, and oncologic quality markers. MethodsAll adult patients undergoing laparoscopic right colectomies between 2015 and 2020 at a single institution were included. ICA and ECA techniques were compared based on selected outcomes using univariable and multivariable statistical analyses, as appropriate. Subgroup analyses were restricted to patients with neoplastic indications for surgery and non-urgent operations.ResultsA total of 517 patients met inclusion criteria, of which 139 (26.9%) underwent ICA and 378 (73.1%) underwent ECA. ICA and ECA patients had similar baseline characteristics. At two years of follow-up, a lower proportion of ICA patients developed a hernia at the extraction incision (1.5% vs. 7.1%, p = 0.02) and ICA was associated with an 80% reduction in extraction incision hernias (aHR 0.20, p = 0.03). These results were stable through subgroup and sensitivity analyses. Median operative time was longer in the ICA group (186 min vs. 135 min, p < 0.001), but the gap in operative time narrowed during the study period. Median length of stay was one calendar day shorter in the ICA group (3 days vs. 4 days, p = 0.007) and ICA was associated with a 13% decrease in the length of stay (aRR 0.87, p = 0.02). The incidence of superficial wound infections, anastomotic leaks and re-interventions was lower in ICA patients, but this difference was not statistically significant. 90-day unscheduled visits, readmissions, and mortalities were similar across both groups, as were oncologic outcomes.ConclusionLaparoscopic right colectomies with intracorporeal anastomoses are associated with a reduction in incisional hernias and shorter hospital lengths of stay without compromising on patient safety or oncologic principles.Graphical abstract Supplementary InformationThe online version contains supplementary material available at 10.1007/s00464-022-09585-0.

Impact and operational feasibility of adding malaria infection screening using an ultrasensitive RDT for placental and fetal outcomes in an area of high IPTP-SP coverage in Burkina Faso: the ASSER MALARIA pilot study protocol

BackgroundMalaria infection during pregnancy (MIP) is not only deleterious to the woman, but it also puts her fetus at increased risk of adverse outcomes, such as preterm delivery, low birth weight, and intrauterine growth retardation. Additionally, all-cause mortality during the first year of life in babies born to women with malaria during pregnancy is also increased. Many interventions such as IPTp-SP and long-lasting insecticidal nets have proven to be efficient at reducing malaria in pregnancy burden but adherence to recommended policies remains poor. In sub-Saharan Africa, malaria in pregnancy is often asymptomatic and many malaria infections may be missed due to the inadequate performance of the current rapid diagnostic test to detect low-level parasitemias. Therefore, additional strategies such as intermittent screening with ultrasensitive rapid diagnostic tests and treatment with an effective artemisinin-based combination therapy in addition to IPTp-SP could reduce placental malaria, peripheral malaria infection at delivery, and low birth weight.MethodsThis pilot 2-group randomized open trial with a nested qualitative social behavioral will be carried out in Nanoro district in which 340 pregnant women will be recruited. Pregnant women will be randomized into two groups and followed on a monthly basis until delivery. In the intervention group, monthly screening using ultrasensitive rapid diagnostic tests and treatment of those found to be infected with dihydroartemisinin-piperaquine will be performed. In addition, a reminder will be sent to increase the uptake of IPTp-SP doses per woman. During scheduled and unscheduled visits, malaria infection, hemoglobin level, and other clinical outcomes will be assessed and compared by the group. The primary feasibility outcome will evaluate the study site's capacity to enroll participants and the women’s perception and acceptability of the intervention. The primary clinical outcome will be the prevalence of placental malaria at delivery.DiscussionThe present protocol aims to evaluate the feasibility on a large-scale and also to demonstrate the impact and the operational feasibility of additional screening with ultrasensitive rapid diagnostic tests and treatment with DHA-PQ on placental malaria, low birth weight, and peripheral malaria infection at delivery in a high-burden setting in Burkina Faso.Trial registrationClinicalTrials.gov, ID: NCT04147546 (14 October 2019).

First Canadian experience with same-day discharge after robot-assisted radical prostatectomy.

We aimed to evaluate the feasibility and safety of implementing a sameday discharge (SD ) protocol for robot-assisted radical prostatectomy (RARP) and pelvic lymph node dissection. We performed a prospective cohort study including all consecutive eligible patients undergoing RARP in 2021 following initiation of SDD RARP protocol in April. Baseline characteristics were compared using t-tests, Mann-Whitney U tests, and odds ratios (OR ) calculated using multiple logistic regression to assess for predictors of SD success. A total of 117 patients underwent RARP in 2021 following initiation of the SDD protocol. Fifty-seven patients were initiated on the SD pathway and 60 patients underwent surgery as an inpatient (IP-RARP). Of those on the SD pathway (SD-RARP), 33 (58%) were successfully discharged the same day of surgery, while 24 (42%) failed SD . Baseline demographics were well-balanced between cohorts. Case order, increased patient age, and distance travelled to the hospital were factors associated with selection of patients for the IP-RARP protocol. In total, 12 SD and 12 IP patients presented to the emergency department (p=1.0), and none within 24 hours of discharge. There were no hospital admissions in the SD cohort, with four readmissions in the IP cohort (p=0.1). Multiple logistic regression revealed that case order (first case) was the only predictive factor for SD success (OR 4.08, 95% confidence interval 1.59-11.62, p=0.005). Implementation of an SD pathway following RARP is feasible, with no increase in rates of complications, unscheduled visits, or readmissions.

Increased versus stable doses of inhaled corticosteroids for exacerbations of chronic asthma in adults and children.

Increased versus stable doses of inhaled corticosteroids for exacerbations of chronic asthma in adults and children.