Objective Clinical Data Research Articles

Improving the Retention Rate of Fat Grafting by Botulinum Toxin A: A Randomized, Self-controlled, Clinical Trial.

Botulinum toxin A (BTX-A) can enhance the efficacy of fat grafting. However, most studies conducted animal experiments, lacked objective clinical data, or were non-randomized controlled trials. Thus, objective evaluation of the clinical effectiveness of BTX-A is still elusive. A randomized, self-controlled trial (2020-2022) on 16 patients who underwent bilateral autogenous fat breast augmentation was performed with each patient receiving autologous fat graft and BTX-A on one side and fat graft and equal volume of saline on the other side. All patients were followed. The effects of BTX-A were evaluated objectively by comparing the remaining bilateral fat graft volumes obtained through digital three-dimensional reconstruction. The improvement of each breast appearance and complication were assessed by the physician and patients who were blinded to the treatment. The outcome of fat breast augmentation was evident for both sides at follow-up with no evidence of fat embolism, vascular/nervous injury, infection, and prolonged bruising. The analysis of the three-dimensional reconstruction data and assessments from both physicians and patients showed significant differences in the fat graft retention volume between the BTX-A side and the control side. No significant difference was found in the incidence of complications between the two sides. Autogenous fat breast augmentation is safe and effective. This study shows that BTX-A can significantly improve the retention rate of fat transplantation, but cannot reduce complications. Trial registration This study was registered prior to patient enrollment (ClinicalTrials.gov identifier:ChiCTR2100054878). This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Introduction to the database “efficacy of different treatment modalities for lower respiratory tract infections in children”

AbstractThis study aimed to establish a registry database of different treatment modalities for lower respiratory tract infections (LRTIs) in Chinese children, thereby filling gaps in knowledge on clinical characteristics, treatment modalities, and rational drug use in relation to LRTIs in Chinese children, and providing large amounts of continuous, complete, scientific, and objective clinical data, and an information exchange platform. Multicenter data from these children's clinical visits were collected, pooled, and analyzed using medical informatics and statistical techniques to explore their potential value. The database was preliminarily established and a real‐world study cohort was constructed based on a total of 4805 patients registered in this database. Pneumonia was identified as the most common type of LRTIs (72.44%), followed by acute bronchitis (20.71%). The mean age of the enrolled children with LRTIs was 3.26 ± 2.84 years, and boys accounted for 59.21% of the samples. Among the enrolled children, pneumonia and acute bronchitis had the highest incidence in children aged 1–3 years (27.44%) and those aged 3–6 years (34.16%), respectively. In this national, multicenter, observational database of LRTIs in children, the real‐world characteristics and treatment modalities for LRTIs in Chinese children are elucidated. This database will help improve the research efficiency of clinicians and facilitate the exploration of underlying clinical patterns in real‐world medical big data.

The use of digital tools in rare neurological diseases towards a new care model: a narrative review.

Rare neurological diseases as a whole share peculiar features as motor and/or cognitive impairment, an elevated disability burden, a frequently chronic course and, in present times, scarcity of therapeutic options. The rarity of those conditions hampers both the identification of significant prognostic outcome measures, and the development of novel therapeutic approaches and clinical trials. Collection of objective clinical data through digital devices can support diagnosis, care, and therapeutic research. We provide an overview on recent developments in the field of digital tools applied to rare neurological diseases, both in the care setting and as providers of outcome measures in clinical trials in a representative subgroup of conditions, including ataxias, hereditary spastic paraplegias, motoneuron diseases and myopathies.

Analysis of Risk Factors for Severe Acute Pancreatitis in the Early Period (

BackgroundSevere acute pancreatitis (SAP) has high mortality. Early identification of high-risk factors that may progress to SAP and active intervention measures may improve the prognosis of SAP patients. ObjectiveClinical data within 24 h after admission were retrospectively analyzed to provide an evidence for early screening of high-risk factors in patients with SAP. MethodsA review of clinical data of acute pancreatitis patients from January 1, 2018, to December 31, 2022, was conducted. We compared the clinical data of SAP and non-SAP patients, and a multivariable logistic regression model was used to identify the independent predictors of SAP. The receiver operating characteristic (ROC) curve of SAP was drawn for continuous numerical variables to calculate the optimal clinical cutoff value of each variable, and the predictive value of each variable was compared by the area under the ROC curve. ResultsBased on the multivariate logistic regression analysis of Age (odds ratio (OR), 1.032;95% confident interval (CI),1.018–1.046, p < 0.001), body mass index (BMI) (OR, 1.181; 95% CI,1.083–1.288, p < 0.001), Non-HTGAP (nonhypertriglyceridemic acute pancreatitis) (OR, 2.098; 95% CI,1.276–3.45, p = 0.003), white blood cell count (WBC) (OR,1.072; 95% CI,1.034–1.111, p < 0.001), procalcitonin (PCT) (OR, 1.060; 95% CI, 1.027–1.095, p < 0.001), serum calcium (Ca) (OR,0.121; 95% CI, 0.050–0.292, p < 0.001), computed tomography severity index (CTSI) ≥4 (OR,12.942;95% CI,7.267–23.049, p < 0.001) were identified as independent risk factors for SAP. The area under the ROC curve (AUC) and optimal CUT-OFF values of continuous numerical variables for predicting SAP were Age (0.6079,51.5), BMI (0.6,23.25), WBC (0.6701,14.565), PCT (0.7086, 0.5175), Ca (0.7787,1.965), respectively. ConclusionAge, BMI, non-HTGAP, WBC, PCT, serum Ca and CTSI≥4 have good predictive value for SAP.

237 Drug–drug interactions and the risk of adverse drug reaction hospital admissions in the older population: a prospective cohort study

Abstract Background Drg–Drg Interactions (DDIs) can lead to medication-related harm; the older population is at greatest risk. We estimate DDI prevalence and the average causal effect of DDI exposure on adverse drug reaction (ADR)-related hospital admission in an older (≥65 years) population admitted acutely to hospital in Ireland. We also examine the effect of DDI exposure on health-related quality of life (HRQoL) and Length of Stay (LoS) in hospital. Methods Prospectively collected (2016–17) data from the Adverse Drg Reactions in an Ageing PopulaTion cohort were used (N = 798). Medication (current/recently-discontinued/over-the-counter) and objective clinical data (e.g. renal function) were available. DDIs (which may result in a life-threatening event/permanent detrimental effect) were identified using the BNF and Stockley’s. Causal inference models were developed using directed acyclic graphs. HRQoL was measured using the EQ-5D-5L. Multivariable logistic regression was performed using SAS (v9.4). Results N = 782 patients using ≥2drugs were included, mean age = 80.9(±7.5); 52.2% female; 92.2% polypharmacy (≥5drugs); 45.1% had an ADR-related hospital admission. N = 316 (40.4% [95% Confidence Interval (CI):37.0–43.9]) patients with at least one DDI at hospital admission. After controlling for confounding, the average causal effect of DDI exposure on ADR-related hospital admission was Odds Ratio (OR) = 1.2 [95% CI: 0.9–1.6]. This risk was significantly increased for patients exposed to DDIs which increase bleeding risk (OR: 2.0 [1.3–3.1]); for aspirin-warfarin (OR: 2.8 [1.4–5.7]) and esomeprazole-escitalopram (OR: 3.2 [1.1–10.3] DDIs. Patients with a DDI had a lower HRQoL (mean EQ-5D: 0.49 [±0.39]) compared to those with none (mean EQ-5D: 0.58 [±0.41], p = 0.08). Patients with an ADR-related hospitalisation and DDI had a significantly greater LoS in hospital (8 [Interquartile Range:5–17] days) compared to those with no DDI (6[Interquartile Range: 3–13] days, p = 0.02). Conclusion DDIs are prevalent among older adults on acute admission to hospital, and increase the risk of ADR-related hospitalisation, significantly for patients with DDIs that increase bleeding risk. Patients with a DDI had lower HRQoL, and prolonged LOS in hospital.

Capability evaluation of a large regional clinical trials unit to assess growth over time.

e13671 Background: Participation in clinical trials is associated with better health outcomes, however prevalence of clinical trial participation among regional and rural patients are low, while simultaneously experiencing poorer health outcomes. Expanding capacity for clinical trials in regional locations increases accessibility for patients who live more remotely. The aim of this study is to describe the growth of a regional Australian clinical trials unit between 2014 and 2022, as part of a validation study of a recently published capability framework. Methods: Survey of Grampians Health Ballarat Clinical Trials unit across 2014 - 2022 was evaluated using a capability framework by Woollett et al. (2023) The framework uses a maturity model which allows a clinical trials unit capacity to be assessed by assigning a score (0-4) across several domains including trial infrastructure, leadership and culture, technology, skilled people, professional networks and collaborations and organisational support. A survey of the Grampians Health Ballarat Clinical Trials Unit was conducted to assign a score for each domain, and the average sum of scores used for an overall assessment; formative (0), developing (1), established (2), high performing (3), leading (4). The number of Principal Investigators (PI), opened trials and new participants recruited annually between 2014 – 2022 was obtained. Scatter plots, pairwise correlation and Bland Altman adjusted for trend were computed to show correlation and agreement between framework and number of PI and new trials opened per year. Results: Across all domains, Grampians Health Ballarat Clinical Trials unit was assessed as ‘established’ (average score 2.6) in 2014, compared to 2022 where the trials unit was considered ‘high performing’ (average score 3.4). Between 2014 and 2022 there was a tenfold increase in new patients recruited annually, n=8 and n=81, respectively. The only trial open in 2014 was investigator initiated, whereas in 2022 67% of trials were industry-sponsored trials. Oncology trials made up 82% of trials conducted, followed by gastroenterology (7%), cardiology (5%), infectious diseases (4%) and neurology (1%). investigators. There was one PI in 2014 compared to 18 in 2022. The framework correlated well with number of PI’s each year (r(7)=0.9 p=0.002) and number of trials opened each year (r(7)=0.8 p=0.015). Bland Altman adjusted for trend found 22% (2/9) outside limits of agreement for overall framework score and number of PI per year and 0% outside limits of agreement for overall framework score and new trials opened per year. Conclusions: This research is among the first to use a framework for outer metropolitan and rural areas to assess clinical trials unit capacity. The framework score correlated well with objective clinical trials data. Understanding the growth of a regional site may provide insight for developing clinical trials capacity in regional and rural areas.

P46: Rationale and Design of a Patient Empowerment Pilot: Self-Administered 6MWT Improve to Outcomes and Timely Utilization of Ventricular Assist Devices

Background: Ventricular assist devices (VAD) are life-saving therapy for appropriately selected end-stage heart failure patients. Although life-prolonging, VAD implantation may accompany considerable lifestyle changes, need for caregiver support, and risk of complications. Furthermore, early evaluation of VAD therapy is important to minimize the exacerbation of cardiac dysfunction. Therefore, shared decision-making through a timely evaluation for VAD therapy is imperative to minimize discrepancies between patient goals and clinical outcomes. The 6-minute walk test (6MWT) is a validated measure to predict morbidity and mortality in advanced heart failure patients, but it can be costly and time-consuming to perform routinely in the clinic. The Timed Walk App is a smartphone application that allows patients to perform a self-directed 6MWT, providing clinicians and patients with opportunities for shared decision-making and a larger database of objective clinical data for VAD evaluation. This study aims to address whether the usage of the Timed Walk App by heart failure patients can improve the clinical outcomes and timely utilization of VAD therapy. Methods: Patients referred to the University of Florida Heart Failure Clinic with an ejection fraction of less than 30% will be considered for study inclusion. Eligible patients will be educated on using the Timed Walk App to self-administer the 6MWT. Patients will be instructed to perform the 6MWT every 15 days and at least once a month. The demographic information, heart failure etiology, and biomarkers of illness severity will be obtained from the electronic medical record. For enrolled patients with VAD implantation, the following data will be collected: time between referral and LAD implantation, hospital length of stay, and incidence of adverse events post-VAD. Quality of life (QOL) assessments using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and EQ-5D will be performed at one-, three-, six-, and twelve-month intervals post-VAD. Data collected will be compared to a retrospective propensity-matched cohort in a weighted 3:1 fashion [Figure]. Results: In comparison to standard clinical assessments, we will analyze whether the use of the Timed Walk App improves: 1) likelihood of implantation 2) time from referral to VAD 3) implant length of stay 4) incidence of post-implant adverse events and 5) patient-reported QOL and perception of care. Conclusion: This study aims to explore whether the patient-directed monitoring of heart failure progression using the Timed Walk App promotes timely and appropriate utilization of VAD therapy. Findings are expected to inform future studies exploring the usage of smartphone applications to facilitate shared decision-making in advanced heart failure patients to improve the quality of life and clinical outcomes of VAD therapy.

Pain severity scale: A methodology for classifying postoperative pain severity by surgical procedure

BackgroundAcute postoperative pain is common following many types of surgery, and a significant subset of patients experience severe pain, which can be difficult to manage and result in postoperative complications. Opioid agonists are commonly used to treat severe postoperative pain, but their use has been associated with adverse outcomes. This retrospective study uses data from the Veterans Administration Surgical Quality Improvement Project (VASQIP) database to develop a postoperative Pain Severity Scale (PSS) based on subjective pain reports and postoperative opioid requirements. MethodsPostoperative pain scores and opioid prescription data were extracted from the VASQIP database for surgeries occurring between 2010 and 2020. Procedures were grouped by surgical Common Procedural Terminology (CPT) codes, and a total of 165,321 surgical procedures were examined, representing 1141 distinct CPT codes. K-means clustering analysis was used to group the surgeries based on 24-h maximum pain, 72-h average pain, and postoperative opioid prescriptions. ResultsK-means clustering analysis showed two optimal grouping strategies; one with 3 and the other with 5 groups. Both clustering strategies produced a PSS that categorized surgical procedures with generally increasing pain scores and opioid requirements. The 5-group PSS accurately captured typical postoperative pain experience across a range of procedures. ConclusionsK-means clustering produced a Pain Severity Scale that can distinguish typical postoperative pain for a large variety of surgical procedures based on subjective and objective clinical data. The PSS will facilitate research into the optimal postoperative pain management and could be used in the development of clinical decision support tools.

The effectiveness of using a homeopathic preparation containing calendula, witch hazel, aesculus, menthol and zinc oxide in patients with nasal obstruction in vasomotor and chronic subatrophic rhinitis

Introduction. In recent years, the world has seen an increase in the number of patients with difficulty in nasal breathing due to nasal obstruction, one of the causes of which are functional disorders of the nasal mucosa in various forms of rhinitis. Frequent use of intranasal decongestants among the population further contributes to the lack of effectiveness of conservative treatment and the need for surgical correction to restore free nasal breathing. This article discusses the possibility of using a homeopathic preparation containing calendula, witch hazel, aesculus, menthol and zinc oxide in patients with nasal obstruction in vasomotor and chronic subatrophic rhinitis to stop the clinical manifestations of the disease and improve the quality of life of patients. Аim. Тo evaluate the effectiveness of a drug containing calendula, witch hazel, aesculus, menthol and zinc oxide in patients with vasomotor and chronic subatrophic rhinitis in the complex treatment of nasal obstruction. Мaterials and methods. The study involved 48 adult patients of both sexes, aged 20 to 50 years, diagnosed with vasomotor (idiopathic) rhinitis in 24 and chronic subatrophic rhinitis in 24 patients. The studied preparation containing calendula, witch hazel, esculus, menthol and zinc oxide was smeared on the mucous membrane of the nasal cavity by laying gauze turundas for 5 minutes, 3 times a day, while the course of treatment was 10 days. The efficacy and safety of the drug was assessed by the dynamics of the severity of subjective symptoms, objective clinical data during control examinations by an otorhinolaryngologist in points, as well as by the presence of side effects in the treatment of the disease. Results. Results of the study showed a pronounced positive trend in the form of relief of subjective complaints and the main clinical manifestations of the disease, accompanied by an improvement in the quality of life in patients in both groups examined during treatment. Side effects were not observed in patients in both study groups. Conclusions. Based on the results of the study, conclusions were drawn about the efficacy and safety of using a complex homeopathic preparation containing calendula, witch hazel, esculus, menthol and zinc oxide in an adult group of patients with nasal obstruction, which makes it possible to recommend it for widespread use for the complex treatment of nasal syndrome. obstruction in vasomotor and chronic subatrophic rhinitis, as well as other forms of rhinitis accompanied by nasal obstruction syndrome.

National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies

Background Several apps for hemophilia care allow for sharing clinical data between patients and healthcare professionals. This study analyzed the use of apps in patients with coagulopaties in Spain. Methods A national survey based on Google® forms included 25 questions: 3 open and 22 closed (5 dichotomous, 12 multiple choices with a single response, 4 multiple responses and 1 Likert scale). Eleven questions were already analyzed in two previous surveys (2017 and 2019). This survey was supported by several Spanish hemophilia associations (ASHECOVA, FEDHEMO, ASANHEMO, etc.) and was sent to patients with hemophilia and other coagulopathies from Spain. Responses were recorded after 2 weeks during 2021. Results The survey was distributed to 116 patients, 76 (65.52%) of which recorded an answer: 65.8% patients and 34.2% caregivers. The median age of the patients was 32.50 years (range 1-63) and 96.1% were male. The diagnosis were: 81.6% hemophilia A, 11.9% hemophilia B and 6.5% other coagulopathies. In 2021, 90.8% of patients periodically registered administration of factors, 73.7% by using mobile apps (2017: 15.8%; 2019: 70%). Regarding their preferences, 85.5% preferred apps for registration (2017: 73.7%; 2019: 88.5%) compared to the manual method (9.2%). The most used apps were (27.6% used 2 apps): Haemoassist (69.7%), florio HAEMO (21.1%), myPKfit app (5.3%), Microhealth (3.9%), and myWAPPS (3.9%). A 22.4% of patient's did not use any app. In patients who used different apps, florio HAEMO was preferred vs Haemoassist in all cases. The most useful functionalities offered by the apps were: administration of factor and bleeding registry (81.7%; 2019: 77.5%), reminders for inyections (45%) and photographic bleeding records (26.7%). The most requested functionalities included: direct communication with the doctor/pharmacist (61.7%), reminder of medical visits (60%) and estimation of the factor level (30%; function not included in Haemoassist and Microhealth). Improvement in treatment adherence was reported in 85% of patients. Patient registries were performed just after the infusion in 56.7% of patients, taking < 3 minutes (73.3%) and were considered easy for 75%. A 53.3% of patients never had problems with the app. The most common problems were: batch number record (26.1%) and app reinstallation (26.1%). Most patients requested a contact person (91.1%) and 94.6% trusted in app confidentiality. Unfortunately, 71.7% of patients stopped the app use for a period >3 months. The most common causes of abandonment were: problems with the mobile phone/app (57.1%), lack of time (21.4%), therapy changes (14.3%), lack of knowledge (7.1%). The overall satisfaction of the patients with the apps was 8.4 over 10. Conclusions Apps provided complete and objective clinical data, reported directly by the patient in real time. This survey showed that apps were the preferred registration method, were simple, provide reliable and useful records and could promote greater adherence. Florio HAEMO was the preferred app by patients due to its estimation of real time factor levels and a more attractive and intuitive design. A high rate of abandonment was reported, probably influenced by telemedicine and technical problems. It is essential to educate in the use of apps and establish a contact person to strengthen their employment.

Abstract 204: Optic Nerve Sheath Diameter Trajectories During Targeted Temperature Management

Introduction: The extent of hypoxic-ischemic injury (HII) after cardiac arrest (CA) remains an important knowledge deficit with lack of objective clinical data that is measurable repeatedly. There is a need to better understand an individual patient’s level of HII. Optic nerve sheath diameter (ONSD) has not been explored after CA as a possible bedside modality to measure the extent of HII over time, at the bedside, during targeted temperature management (TTM). Objective: We sought to characterize the temporal trajectories of point-of-care ultrasound obtained ONSD during the post- return of spontaneous circulation (ROSC) phase, in patients with and without TTM. Methods: Adult CA patients at an urban academic ED were included from 2017-2021. ONSD was measured by emergency ultrasound fellowship trained faculty at 1, 6, 24, 48, and 72 hours after ROSC using an ocular preset on a 15MHz linear probe. ONSD measurements at these time points were compared with patient demographic information and intervention of TTM . Results: A total of 78 participants had ONSD measurements. The mean age was 62 (+/-15) and 46% were female. Of the 65% of the cases with TTM, a sex disparity was noted with 73% of males receiving TTM versus 56% of females. There was a trend toward a decrease in mean ONSD by 0.015cm for TTM patients during the early time points of 1 to 6 hours compared to an increase in 0.006cm in those without TTM. Similar trend was noted between 1 to 24 hours, with a decrease in ONSD by 0.025cm in those with TTM relative to an average increase of 0.008 cm in those without TTM. However, neither delta ONSD was statistically significant between the two cohorts. When further assessing if delay in cooling had an impact on ONSD change, we found that the ONSD change between 24 to 48 hours was significantly increased in those in whom TTM was not initiated within 14 hours (beta=0.036; p=0.016). Conclusion: This pilot study revealed ONSD changes during TTM. There is potential for monitoring brain injury through ONSD trajectories to evaluate responders vs non-responders to TTM. Additional research is needed to evaluate ONSD changes during the rewarming time frame and may further distinguish patients with worse HII. Correlation to survival outcomes can be possible with a larger sample size.

Gut microbiota differences between psoriatic arthritis and other undifferentiated arthritis: A pilot study.

Psoriatic arthritis (PSA) is a form of immune-mediated inflammatory arthritis that predominantly begins with enthesitis. Studying the gut microbiota of PSA patients may offer new insights into the pathogenesis of enthesitis, compared to other arthritis. We designed a prospective study to examine gut microbiome of patients with PSA, primarily with enthesitis and dactylitis, and compared the data with other undifferentiated types of arthritis (NO PSA) patients, without enthesitis or dactylitis. We enrolled 9 PSA patients and 10 NO PSA patients in this study. We excluded rheumatoid arthritis, systemic lupus erythematosus, Sjogren syndrome, systemic sclerosis, mixed connective tissue disease, polymyositis, dermatomyositis, ANCA-associated vasculitis, and gouty arthritis patients. The fecal samples were investigated using 16S rRNA amplicon sequencing, followed by bioinformatics and statistical analyses. None of the available objective clinical laboratory data could differentiate PSA group from the NO PSA subgroup. The microbiota result shows that Family: XIII_AD3011 is significantly higher in NO PSA patients' than in PSA patients' stool samples (P = .039). Megasphaera elsdenii in the PSA group was 10,000 times higher than in the NO PSA group.Our results demonstrated high intragroup homogeneous and high intergroup heterogeneous microbiota. The clinical symptoms of either enthesitis or dactylitis are associated with higher presence of specific microbiota in the current study. The PSA and other undifferentiated arthritis could be differentiated with microbiota analysis. In the future, a larger cohort and thorough biochemical study are needed for confirmation.The microbiota is different between PSA and NO PSA patients, and the species could be used as a differential diagnostic tool between these 2 diseases. The clinically available serum markers may not be enough to reflect the details of patients with different patterns of arthritis. Megasphaera elsdenii species could be a link between gut flora and enthesitis and/or dactylitis clinically in PSA. We confirm the fact that the Bifidobacterium longum correlates negatively with eosinophils.

Palliative Care for Patients With Heart Failure: Results From a Heart Failure Society of America Survey

Multiple guidelines recommend specialty palliative care (PC) for patients with heart failure (HF), including patients with left ventricular assist devices (LVADs). However, the degree of integration and clinicians' perceptions of PC in HF care remain incompletely characterized. A 36-item survey was sent to 2109 members of the Heart Failure Society of America. Eighty respondents (53% physicians), including 51 respondents from at least 42 medical centers, completed the survey, with the majority practicing in urban (76%) academic medical centers (62%) that implanted LVADs (81%). Among the 42 unique medical centers identified, respondents reported both independent (40%) and integrated (40%) outpatient PC clinic models, whereas 12% reported not having outpatient PC at their institutions. A minority (12%) reported that their institution used triggered PC referrals based on objective clinical data. Of respondents from LVAD sites, the majority reported that a clinician from the PC team was required to see all patients prior to implantation, but there was variability in practices. Among all respondents, the most common reasons for PC referral in HF were poor prognosis, consideration of advanced cardiac therapies or other high-risk procedures and advance-care planning or goals-of-care discussions. The most frequent perceived barriers to PC consultation included lack of PC clinicians, unpredictable HF clinical trajectories and limited understanding of how PC can complement traditional HF care. PC integration and clinician perceptions of services vary in HF care. More research and guidance regarding evidence-based models of PC delivery in HF are needed.

Breast Reconstruction: Impact of the Procedure on Quality of Life

English Breast cancer and the surgical procedures associated with it have a major impact on the quality of life of affected patients. Research shows that the loss of the breast and the associated change in body image have a major impact on the female self-image for many women. This has a strong negative impact on the quality of life of those affected. With modern clinical outcome research including treatment results from the patient's perspective in the form of patient-reported outcome measures (PROMs), the satisfaction and quality of life of those affected can be measured, analysed and compared. This review examines the extent to which breast reconstruction improves the quality of life for many women and how the different reconstruction methods vary in their impact on quality of life and satisfaction. In addition, the review discusses the importance of standardised recording and analysis of PROMs in combination with objective clinical data and their integration into the treatment process, and it demonstrates implementation options. Such systematic recording of PROMs enables the creation of databases and registers, the evaluation of which provides information that can be used for scientific and clinical purposes. Based on these research results, prognostic models can be created and treatment results can be examined in comparative studies facilitating clinical decision-making and quality controls.

The diagnosis of hip microinstability is correlated with ease of intra-operative hip distraction.

Hip microinstability has emerged as a contributor to young adult, non-arthritic hip pain. There is a paucity of objective clinical data to identify patients with hip microinstability and guide surgical treatment. The purpose of this study was to identify the degree of distractibility in patients with and without microinstability undergoing hip arthroscopy. A single-surgeon series of hip arthroscopies were retrospectively reviewed from 2014-2020. All procedures were performed with paralysis on a fracture table with a perineal post where 1 turn of fine traction equates to 4mm of axial traction. Diagnosis was recorded as isolated instability, instability plus femoroacetabular impingement (FAI), and isolated FAI. Operative reports were reviewed to collect patient demographic data, number of turns of traction required for adequate distraction of the femoral head relative to the acetabulum (10mm), and the presence of residual subluxation after initial traction was released. A total of 464 patients were identified, 26 (5.6%) with isolated microinstability, 183 (39.4%) with microinstability with FAI anatomy, and 255 (55.0%) with FAI. The concurrent diagnosis of microinstability was associated with decreased turns required to adequately distract the hip. Isolated microinstability patients required 6.9 turns (IQR 4.6-8.8) while those with instability plus FAI required 8.8 turns (IQR 6.5-11) and isolated FAI required 19.1 turns (IQR 15-22). Residual subluxation after removal of negative intra-articular pressure but before performing the hip arthroscopy was more commonly associated with instability, occurring in 84.6% of isolated instability and 86.9% of instability plus FAI as compared with 29.8% in the isolated FAI cohort. A diagnosis of hip microinstability, with or without features of FAI, is associated with decreased axial traction required to distract the hip. These data support the use of intra-operative ease of distraction as a method of identifying patients with hip microinstability. Level III.

Results of clinical trials of a specialized product for enteral nutrition: Nutrigen Low Fat

BACKGROUND: Hereditary disorders of fatty acid oxidation are a group of fermentopathies caused by biallelic mutations in genes encoding enzymes of the mitochondrial -oxidation cascade of fatty acids. Mitochondrial fatty acid oxidation deficiency is a genetically heterogeneous group of diseases in humans caused by defects in mitochondrial fatty acid -oxidation. A common characteristic of all mitochondrial fatty acid -oxidation disorders is hypoketotic hypoglycemia, resulting from an increased dependence on glucose oxidation and an inability to synthesize ketone bodies from fatty acids. The clinical manifestations of diseases in this group are highly variable. Patients with a defect in the oxidation of long-chain fatty acids are at risk of developing cardiac and skeletal muscle abnormalities, including cardiomyopathy and arrhythmias, which can progress to early death, as well as rhabdomyolysis and exercise intolerance. The optimal composition of Nutrigen Low Fat enteral mixture allows its use in children with intestinal dysfunction and metabolic disorders as a component of nutritional support or the sole source of nutrition.&#x0D; AIMS: To study the clinical evidence on intestinal insufficiency syndrome in critically ill children, to assess the role of enteral nutrition in intestinal dysfunction prevention and treatment in critically ill patients in the pediatric intensive care unit, and to perform clinical monitoring of young children with inborn errors of fatty acid oxidation.&#x0D; MATERIALS AND METHODS: Twelve children aged 3 months to 7 years with digestive dysfunction took part in the study. The study duration was 3 weeks. During the intervention, children received the product Nutrigen Low Fat in accordance with their age and individual nutritional needs. Throughout the study, the childrens nutritional status and the dynamics of digestive dysfunction were taken into account. A clinical trial of the dry complete enteral product Nutrigen Low Fat took place from May to August of 2021. A clinical trial of the product was conducted against a background of generally accepted medical treatment in accordance with the character of the disease. The study design was an observational, longitudinal cohort study.&#x0D; RESULTS: The dynamics of objective clinical and laboratory data, as well as subjective patient characteristics, indicated an improvement in well-being, physical development, and positive dynamics of blood parameters. The product Nutrigen Low Fat meets the hygienic requirements for the composition and quality of pediatric medical nutrition products and has good organoleptic characteristics. It should be noted that Nutrigen Low Fat is convenient to use because it allows individual selection of the dilution and dosage in accordance with the childs age and clinical status, has a high biological value (contains easily absorbed fat, with 84% medium-chain triglycerides, and easily digestible milk protein comprised of 60% whey). The products gluten-free formula is another advantage.&#x0D; CONCLUSIONS: All of the above allows us to recommend the use of a complete product, Nutrigen Low Fat, as a supplement to the diet or as the sole source of nutrition. It can be used for oral nutrition (sipping) or tube feeding from birth in children with acute surgical and therapeutic diseases, as well as orphan inborn errors, including fatty acid oxidation errors, with maldigestion and malabsorption syndrome, intoxication, and malnutrition.

Variability of urodynamic parameters in patients with idiopathic overactive bladder before intradetrusor botulinum toxin injections

Introduction. The aim of study was to establish if the treatment of overactive bladder in women and its result reported by patients were different depending on the findings of urodynamics, performed before botulinum toxin injection. We obtained clinical data based on the necessity and importance of performing urodynamic tests up to surgical treatment with botulinum toxin A injection in detrusor muscle, at patients diagnosed with idiopathic overactive bladder and detrusor overactivity, offering a guarantee of an effective and long-lasting treatment and assure with predictive parameters for some postoperative complications. Material and methods. The research was carried out at the Department of Urology and Surgical Nephrology, during the years 2019 – 2022. After applying the inclusion and exclusion criteria, 36 women diagnosed with overactive bladder were enrolled in the prospective pilot study, aged between 18 and 70 years, refractory to drug treatment and investigated urodynamic by excluding/including the presence of detrusor overactivity and clinically using voiding diary/24h, bladder symptoms and Quality of Life questionnaires before and after botulinum toxin A injection. The primary data were analyzed and presented as a mean and standard deviation. Results. All women involved in the study were diagnosed clinically and urodynamic with overactive bladder, of which 55.5% of cases were associated with detrusor overactivity and subsequently received BTX-A injectable surgical treatment with a dose of 100U. At urodynamics, the low values of the indices obtained at cystometry were established: first sensation of bladder filling (79.8 ± 56.3 ml), first desire to void (117.8 ± 103.2 ml), strong desire to void (162 ± 125 ml) and maximal cystometric capacity (183.4 ± 139.8 ml), which correlated in 100% cases with OAB symptoms (urinary urgency, frequency and nocturia) from the OABSS validated questionnaire. The capacity of the bladder at each sensation was lower, being inversely proportional to the detrusor overactivity present in women with OAB. Based on UDS data, the diagnosis of OABi with detrusor overactivity was confirmed by establishing the presence of phasic detrusor contractions (3.9 ± 1.1), increased values of detrusor pressure (45.9 ± 23.9 cmH2O) and the presence of bladder hypocompliance (10.6 ± 11.5 ml/cmH2O), these data in 100% of cases predicted an effective BTX-A injection. Daily activity and psychosocial behavior improved after intradetrusor botulinum injections toxin was influenced by reducing daytime urination from 28% to 40% and urinary urgency from 30 to 69%. Conclusions. This study identified a number of statistically significant urodynamic variables associated with objective clinical data, which confirm the impact of severity of idiopathic overactive bladder symptoms and the subsequent effect of botulinum toxin type A injections in case of urodynamic confirmation of detrusor overactivity presence.

Deep Clinical Phenotyping of Parkinson's Disease: Towards a New Era of Research and Clinical Care.

Despite recent advances in technology, clinical phenotyping of Parkinson's disease (PD) has remained relatively limited as current assessments are mainly based on empirical observation and subjective categorical judgment at the clinic. A lack of comprehensive, objective, and quantifiable clinical phenotyping data has hindered our capacity to diagnose, assess patients' conditions, discover pathogenesis, identify preclinical stages and clinical subtypes, and evaluate new therapies. Therefore, deep clinical phenotyping of PD patients is a necessary step towards understanding PD pathology and improving clinical care. In this review, we present a growing community consensus and perspective on how to clinically phenotype this disease, that is, to phenotype the entire course of disease progression by integrating capacity, performance, and perception approaches with state-of-the-art technology. We also explore the most studied aspects of PD deep clinical phenotypes, namely, bradykinesia, tremor, dyskinesia and motor fluctuation, gait impairment, speech impairment, and non-motor phenotypes.

Inclusion of social determinants of health improves sepsis readmission prediction models.

Sepsis has a high rate of 30-day unplanned readmissions. Predictive modeling has been suggested as a tool to identify high-risk patients. However, existing sepsis readmission models have low predictive value and most predictive factors in such models are not actionable. Data from patients enrolled in the AllofUs Research Program cohort from 35 hospitals were used to develop a multicenter validated sepsis-related unplanned readmission model that incorporates clinical and social determinants of health (SDH) to predict 30-day unplanned readmissions. Sepsis cases were identified using concepts represented in the Observational Medical Outcomes Partnership. The dataset included over 60 clinical/laboratory features and over 100 SDH features. Incorporation of SDH factors into our model of clinical and demographic features improves model area under the receiver operating characteristic curve (AUC) significantly (from 0.75 to 0.80; P < .001). Model-agnostic interpretability techniques revealed demographics, economic stability, and delay in getting medical care as important SDH predictive features of unplanned hospital readmissions. This work represents one of the largest studies of sepsis readmissions using objective clinical data to date (8935 septic index encounters). SDH are important to determine which sepsis patients are more likely to have an unplanned 30-day readmission. The AllofUS dataset provides granular data from a diverse set of individuals, making this model potentially more generalizable than prior models. Use of SDH improves predictive performance of a model to identify which sepsis patients are at high risk of an unplanned 30-day readmission.

Visual Fatigue as a Predictor of Exercise Tolerance in Pediatric Athletes with Concussion

Background:Concussion patients may manifest changes in exercise tolerance (ET). Since the visual system is affected as well, investigating the relationship between ET and vision could prove useful in developing better rehabilitation strategies.Hypothesis/Purpose:To explore trends between ET and visual fatigue in pediatric concussion patients.Methods:A Retrospective chart review of 63 pediatric concussion patients ages 12-21 was collected from 11/05/21 to 6/10/21. Each patient completed a validated symptom-related questionnaire resulting in quantitative clinical profile (CP) score (0-89) and ocular profile subtype (OPS) score (0-3) with higher scores indicating worse symptoms. The OPS score is a weighted score based off of 5 vision focused questions regarding visual symptoms and visual fatigue. Each patient was also evaluated by a physician and classified into an active rehabilitation (AR) step (Step 1-5) based on exertional testing results using heart rate to establish exertional threshold at the visit. Patients were split up into low ET level (n=10) who could not exceed HR<140bpm and high ET level (n=53) who exhibited vigorous to maximal intensities all tolerating HR>140bpm. Near point convergence (NPC) and other objective exam markers were also evaluated at each patient visit. A paired two sample t-test compared the differences in their OPS and objective clinical data.Results:The low ET group averaged an OPS score of 1.84, CP score of 43.20, and a physician measured average NPC of 9.96 cm, while the high ET group averaged an OPS score of 0.68, CP score of 13.87, and a physician measured NPC of 9.06 cm (Table 1). T-test for the OPS and CP score revealed statistically significant differences (p value of 4.04E-05 and 3.49E-06 respectively) while the t-test for NPC had a p-value of 0.491.Conclusion:Visual fatigue as endorsed by the OPS score may be a critical subjective marker in predicting ET in pediatric athletes after concussion. Those tolerating vigorous or maximal exertion generally had significantly lower OPS scores, despite similar NPC findings in this small sample. Further studies are required to confirm this trend and how it may affect exertional rehabilitation strategies.Table 1:Ocular Profile Score (OPS), Near Point Convergence (NPC), Clinical Profile Score (CPS) in low vs high exercise tolerance (ET) patients