Single Study Design Research Articles

Exploring intra-diagnosis heterogeneity and inter-diagnosis commonality in genetic architectures of bipolar disorders: association of polygenic risks of major psychiatric illnesses and lifetime phenotype dimensions.

Bipolar disorder (BD) shows heterogeneous illness presentation both cross-sectionally and longitudinally. This phenotypic heterogeneity might reflect underlying genetic heterogeneity. At the same time, overlapping characteristics between BD and other psychiatric illnesses are observed at clinical and biomarker levels, which implies a shared biological mechanism between them. Incorporating these two issues in a single study design, this study investigated whether phenotypically heterogeneous subtypes of BD have a distinct polygenic basis shared with other psychiatric illnesses. Six lifetime phenotype dimensions of BD identified in our previous study were used as target phenotypes. Associations between these phenotype dimensions and polygenic risk scores (PRSs) of major psychiatric illnesses from East Asian (EA) and other available populations were analyzed. Each phenotype dimension showed a different association pattern with PRSs of mental illnesses. PRS for EA schizophrenia showed a significant negative association with the cyclicity dimension (p = 0.044) but a significant positive association with the psychotic/irritable mania dimension (p = 0.001). PRS of EA major depressive disorder demonstrated a significant negative association with the elation dimension (p = 0.003) but a significant positive association with the comorbidity dimension (p = 0.028). This study demonstrates that well-defined phenotype dimensions of lifetime-basis in BD have distinct genetic risks shared with other major mental illnesses. This finding supports genetic heterogeneity in BD and suggests a pleiotropy among BD subtypes and other psychiatric disorders beyond BD. Further genomic analyses adopting deep phenotyping across mental illnesses in ancestrally diverse populations are warranted to clarify intra-diagnosis heterogeneity and inter-diagnoses commonality issues in psychiatry.

P998 Phase 2 basket design study evaluating the efficacy and safety of an anti-TL1A antibody (TEV-48574) in moderate to severe ulcerative colitis or Crohn's Disease (RELIEVE UCCD)

Abstract Background TEV-48574 is a human antibody that targets tumor necrosis factor (TNF)-like ligand 1A, also known as TNF superfamily member 15 (TNFSF15). TEV-48574 is being evaluated in the first basket design trial in IBD. The basket design is uniquely suited for the efficient assessment of TEV-48574 as evidence suggests that TL1A signaling plays a key role in both ulcerative colitis (UC) and Crohn’s disease (CD). TL1A signaling is not a primary driver but an amplifier of inflammation; thus, targeting TL1A should mitigate excessive immune responses while leaving baseline immunity intact. Originating in oncology trials, the basket trial design has emerged as a new efficient approach for testing treatment efficacy in different disease indications with potentially common molecular mechanisms. The basket design approach allows the evaluation of multiple indications in a single study design that provides adequate support for initiation of confirmatory studies. Additionally, the basket design allows for shared sites and institutional review boards, data collection and analyses under consistent conditions. Herein, we describe the phase 2b basket trial evaluating TEV-48574 in UC and CD (clinicaltrials.gov NCT05499130), currently ongoing along with a long-term extension study (LTE)(NCT05668013). Methods In this double-blind placebo-controlled global study, TEV-48574 or placebo is administered subcutaneously to adults (n = 240) diagnosed with moderate-to-severe IBD (UC (n = 120) or CD (n = 120)). Patients who meet pre-specified inclusion/exclusion criteria are randomized to either one of two TEV-48574 dose regimens or placebo in a 1:1:1 ratio (stratified by diagnosis (UC or CD) and previous exposure to advanced IBD therapy(biologics and small molecules)) for 14 weeks. Patients who complete the 14-week induction period have the option to enter the LTE, consisting of a 44-week maintenance period for responders and a re-induction period for non-responders. Primary efficacy endpoints are induction of clinical remission (a modified Mayo Score of ≤2 points for UC), and endoscopic response (a reduction in Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 50% from baseline) for CD, at week 14. A Bayesian approach will be used to compute posterior probabilities for the response endpoints within each indication. Additional endpoints include safety assessments, measures of clinical response, biomarkers, pharmacokinetics, and immunogenicity. Results Conclusion TEV-48574 is a potential novel treatment option for patients with UC and CD that may have dual antifibrotic and anti-inflammatory effects. The phase 2 basket study design offers an efficient approach to advance TEV-45874to confirmatory phase 3 studies.

The Impact of Physiotherapy Interventions on the Elderly Population with Mental Health Conditions at Chainama Hills College Hospital in Zambia. A Pre-Post Single Sample Study Design

The Impact of Physiotherapy Interventions on the Elderly Population with Mental Health Conditions at Chainama Hills College Hospital in Zambia. A Pre-Post Single Sample Study Design

Relationship between heart rate variability and differential patterns of cortisol response to acute stressors in mid-life adults: A data-driven investigation.

Cortisol and heart rate variability (HRV) are well-established biomarkers of the human stress response system. While a relationship between cortisol and HRV is assumed, few studies have found evidence of their correlation within single study designs. One complication for isolating such a relationship may lie in individual variability in the cortisol response to stress such that atypical cortisol responding (i.e., elevated or blunted) occurs. To-date, studies on the cortisol response have employed traditional mean-difference-based approaches to examine average magnitude change in cortisol over time. Alternatively, data-driven trajectory modelling, such as latent growth mixture modelling, may be advantageous for quantifying cortisol based on patterns of response over time. Latent growth mixture modelling was used in N=386 adults to identify subgroups based on trajectories of cortisol responses to stress. The relationship between cortisol and HRV was tested within subgroups. Results revealed a 'prototypical' subgroup characterised by expected rise and fall in cortisol response to stress (n=309), a 'decline' subgroup (n=28) that declined in cortisol after stress, and a 'rise' subgroup (n=49) that increased in cortisol after stress. Within the 'prototypical' subgroup, greater HRV during stress was associated with decline in cortisol after stress from its maximum (r (306)=0.19, p<0.001). This relationship failed to emerge in the 'decline' and 'rise' subgroups (p>0.271). Results document different patterns of cortisol response to stress; among those who exhibit a 'prototypical' response, changes in HRV during stress are related to changes in cortisol after stress.

Telehealth Equivalence of the Montreal Cognitive Assessment (MoCA): Results from the Emory Healthy Brain Study (EHBS) (P6-6.001)

<h3>Objective:</h3> To characterize potential differences in Montreal Cognitive Assessment (MoCA) performance between in-person cognitive testing and video telehealth administration. In addition to global MoCA scores, we examined potential telehealth effects on mood (PHQ-8, GAD-7), and explored whether the presence of an observer at the participant’s home during remote MoCA testing influenced task performance. <h3>Background:</h3> Telehealth cognitive testing has become a common assessment approach following the COVID-19 pandemic when in-person testing was restricted for safety considerations. Although the equivalence of telehealth results to the traditional face-to-face testing is often assumed, formal equivalence validation is limited. <h3>Design/Methods:</h3> Scores from participants in the Emory Health Brain Study (EHBS) were contrasted based upon whether they were tested in the standard face-to-face (F2F) assessment (<i>n</i>=1205) or using a video telehealth administration (<i>n</i>=491). All EHBS participants were cognitively normal via self-report. <h3>Results:</h3> Total MoCA scores did not differ across administration method (F2F MoCA=26.6, <i>SD</i>=2.4, telehealth MoCA=26.5, <i>SD</i>=2.4). The 95% confidence interval for difference in administration was small (CI = −0.16 – 0.34). When examining individual MoCA domain scores, administration differences were either associated with no statistically significant effect, or if present were due to large sample sizes, were associated with small effect sizes and differences &lt; 0.5 point. Groups did not differ on GAD-7, although F2F patients reported slightly higher GAD-7 scores of 0.4 point but well within the normal range. The presence of an observer during telehealth testing did not influence MoCA scores. <h3>Conclusions:</h3> While no single study design provides complete evidence of task equivalence between in-person and video telehealth assessment, this report with its large sample size and between subject cohort provides reassurance that administration mode does not introduce systematic performance differences for MoCA test administration. Continuing studies in clinically impaired groups will be needed to demonstrate the robustness of our findings. <b>Disclosure:</b> Dr. Loring has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer Nature. Dr. Loring has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for ILAE. The institution of Dr. Loring has received research support from NIH. Dr. Loring has received publishing royalties from a publication relating to health care. Dr. Lah has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche Diagnostics. The institution of Dr. Lah has received research support from Roche. Felicia Goldstein has nothing to disclose.

Deep palmar phenotyping in atopic eczema: patterns associated with Filaggrin variants, disease severity and barrier function in a South Asian population.

Hyperlinear palms are described as a feature of loss-of-function (LoF) variants in Filaggrin (FLG). To explore the phenotype of participants (age <31 years) with atopic eczema of Bangladeshi ancestry from East London and investigate which factors best associate with LoF FLG variants. A cross-sectional study with participants recruited between May 2018 and March 2020. Patterns of palmar linearity were categorised and modelled with Eczema Area and Severity Index (EASI), transepidermal water loss (TEWL), skin hydration (SH) and LoF FLG variants. Five hundred and six complete cases were available. Five palm patterns were noted. The 'prominent diamond' pattern associated best with EASI (marginal effects [ME], 2.53, 95% CI 1.74-3.67), TEWL (ME 1.32, 95% CI 1.11-1.62) and SH (ME 0.85, 95% CI 0.78-0.96). Using five palm patterns had some ability to discriminate LoF FLG variants (area under the receiver operator characteristic [AUROC] 76.07; 95% CI 71.58-80.57), improving in subgroup analysis with only fine perpendicular/prominent diamond patterns and SH (AUROC 89.11%; 95% CI 84.02-94.19). Single centre study design with humans classifying clinical patterns. Stability of temperature and humidity not guaranteed across TEWL and SH measurements despite using a climate controlled room. Palm patterns associate with EASI and TEWL. The fine perpendicular/prominent diamond patterns are markers to detect absence/presence of LoF FLG variants respectively.

La prostatectomía radical retropúbica abierta es todavía una técnica quirúrgica bien establecida para el tratamiento del cáncer de próstata

IntroductionThe surgical treatment options for prostate cancer have changed rapidly, given the expansion of robotics. However, open retropubic radical prostatectomy (ORP) will continue to be performed in areas with financial limitations or with limited access to robotics. The purpose of this study was to determine the long-term oncological outcomes, to categorize complication rates and to examine the early continence rates in patients treated with ORP. MethodsWe identified all patients who underwent ORP at our institution between 2000 and 2020. A standardized pad test was used to determine the early continence rates upon catheter removal, the late continence around a year after surgery was determined by the number of pads per day. The Clavien-Dindo classification was used to report the complication rates. The biochemical recurrence (BCR)-free survival and overall survival (OS) rates were defined using the Kaplan-Meier method and log-rank analysis. Multivariable Cox-regression models were used to test the effect of different factors on biochemical recurrence. ResultsWe analyzed 1095 patients. The median follow-up was 93.4months. An overall 10-year BCR-free survival and OS of 73% and 82% respectively was found. A complication rate for Clavien Dindo ≥3 was seen in 4.8% of patients. The early continence rate was 81.4% and the late continence 89.1%. Preoperative PSA level, Gleason score sum, pT stage, lymph node status, and surgical margin status were independent predictors of BCR (P<.001). Limitations include retrospective and single centre study design. ConclusionsORP is a surgical procedure that provides excellent oncological- and early continence-rates.

The longitudinal trajectory of discourse from the hyperacute to the chronic phase in mild to moderate poststroke aphasia recovery: A case series study.

Discourse analysis has recently received much attention in the aphasia literature. Even if post-stroke language recovery occurs throughout the longitudinal continuum of recovery, very few studies have documented discourse changes from the hyperacute to the chronic phases of recovery. To document a multilevel analysis of discourse changes from the hyperacute phase to the chronic phase of post-stroke recovery using a series of single cases study designs. Four people with mild to moderate post-stroke aphasia underwent four assessments (hyperacute: 0-24h; acute: 24-72h; subacute: 7-14 days; and chronic: 6-12 months post-onset). Three discourse tasks were performed at each time point: a picture description, a personal narrative and a story retelling. Multilevel changes in terms of macro- and microstructural aspects were analysed. The results of each discourse task were combined for each time point. Individual effect sizes were computed to evaluate the relative strength of changes in an early and a late recovery time frame. Macrostructural results revealed improvements throughout the recovery continuum in terms of coherence and thematic efficiency. Also, the microstructural results demonstrated linguistic output improvement for three out of four participants. Namely, lexical diversity and the number of correct information units/min showed a greater gain in the early compared with the late recovery phase. This study highlights the importance of investigating all discourse processing levels as the longitudinal changes in discourse operate differently at each phase of recovery. Overall results support future longitudinal discourse investigation in people with post-stroke aphasia. What is already known on the subject Multi-level discourse analysis allows for in-depth analysis of underlying discourse processes. To date, very little is known on the longitudinal discourse changes from aphasia onset through to the chronic stage of recovery. This study documents multi-level discourse features in four people with mild to moderate aphasia in the hyperacute, acute, subacute and chronic stage of post-stroke aphasia recovery. What this paper adds to existing knowledge The study found that most discourse variables demonstrated improvement throughout time. Macrostructural variables of coherence and thematic units improved throughout the continuum whereas microstructural variables demonstrated greater gains in the early compared to the late period of recovery. What are the potential or actual clinical implications of this work? This study suggests that multilevel discourse analysis will allow a better understanding of post-stroke aphasia recovery, although more research is needed to determine the clinical utility of these findings. Future research may wish to investigate longitudinal discourse recovery in a larger sample of people with aphasia with heterogenous aphasia profiles and severities.

Effectiveness of progressive resistance training in improving muscle strength in myasthenia gravis: a single subject study design

Effectiveness of progressive resistance training in improving muscle strength in myasthenia gravis: a single subject study design

240. Antibiotic Overuse Among Children with COVID-19 Hospitalized in a Pediatric Intensive Care Unit

Abstract Background Antibiotic overuse has been well described among hospitalized adults with COVID-19 but similar evaluations in children are lacking. We sought to quantify bacterial infection rates and antibiotic utilization among critically ill children hospitalized with COVID-19 to identify opportunities to optimize care. Methods We performed a single center retrospective cohort study of all children hospitalized with symptomatic COVID-19 in a pediatric intensive care unit between May 16, 2020 and February 11, 2022 at a tertiary care children’s hospital in the Southeastern U.S. We performed medical record review to abstract demographic and clinical characteristics. This study was approved by the institutional IRB with a waiver of consent. Results During the study period there were 92 subjects hospitalized in the intensive care unit with COVID-19. Demographic and clinical characteristics of the cohort are summarized in the Table. Median age was 12.4 years, median length of stay was 6 days, 32% of subjects required mechanical ventilation and 5% died. The vast majority of children had one or more comorbidities and only 1 subject was fully vaccinated against SARS-CoV-2. Thirteen (14%) subjects had bacterial growth from any clinical specimen. Eight subjects had respiratory cultures that may have represented airway colonization; when these were excluded, 5 (5%) subjects had either urinary tract or bloodstream infections. Two of the bloodstream infections were caused by drug-resistant organisms and were hospital-acquired. Despite the low number of subjects with bacterial infections, 45% received antibiotics for &amp;gt;3 days. The antibiotic days of therapy per subject varied widely and ranged from 0 to 61 days. Conclusion In this cohort of nearly 100 critically ill children with COVID-19, the rate of culture-confirmed bacterial infection ranged from 5-14% yet nearly half of patients received antibiotics. Limitations include the single center and retrospective study design and the fact that bacterial pneumonia may not be culture-confirmed. Despite these limitations, this work suggests that children with COVID-19 rarely have bacterial co-infections and are often prescribed unnecessary antibiotics. Disclosures All Authors: No reported disclosures.

Using space to event modeling to estimate density of multiple species in northeastern Washington

AbstractConcurrent monitoring of multiple species with a single study design can be an efficient use of time and financial resources. Using camera traps to estimate density or abundance of multiple species is only possible if the study design captures photographs of all target species in an unbiased manner. We used camera trap data originally collected for a different purpose and applied the Space to Event (STE) model to estimate density of multiple species simultaneously. We had sufficient data to estimate densities of moose (Alces alces), black bear (Ursus americanus), mountain lions (Puma concolor), wolves (Canis lupus), and deer (white‐tailed deer [Odocoileus virginianus] and mule deer [O. hemionus] combined). Our estimated densities were lower than those derived from other methods in the study area, possibly due to the lack of a sampling design specific to STE. However, our estimates were generally comparable to published density estimates from across the species' range. Our approach allowed us to estimate abundance and density for each species with the same effort required to estimate abundance of a single species. Our results suggest that with an appropriate study design, STE could be an effective, efficient, low cost and non‐invasive method for estimating densities of multiple unmarked species using a single camera array.

Healthcare Resource Utilization in Acute Myeloid Leukemia Treatments: Hypomethylating Agent + Venetoclax Vs. High Intensity Regimens

Background Treatment of acute myeloid leukemia (AML) leads to significant healthcare resource utilization (HRU), including extended hospitalization and transfusions. Standard treatment regimens include the high intensity "7+3” (anthracycline + cytosine arabinoside) and CPX-351 (daunorubicin + cytarabine liposome) used in younger, fit patients, and the lower intensity hypomethylating agent + venetoclax (HMA-Ven) used in patients deemed ineligible for intensive induction. Previous reports show comparable remission rates between regimens. Studies have shown no significant difference in HRU between 7+3 and CPX-351, but there have yet to be reports on HRU for HMA-Ven compared to high intensity regimens. Methods We retrospectively analyzed patients with newly diagnosed AML treated at UC Davis Medical Center from 5/2012 to 5/2021 with HMA-Ven, 7+3, or CPX-351, identified using pharmacy and EMR reports. Patients met criteria if they achieved first complete remission with (CR) or without (CRi) count recovery as per ELN 2017 criteria. The date of CR1 was defined as date of first bone marrow biopsy following induction with evidence of CR/CRi. Primary outcomes assessed were number of packed red blood cell (pRBC) units transfused, platelet (Plt) units transfused, and hospital days (HDs) from start of treatment to CR1. Secondary outcomes assessed were HRU in 60 and 90 days post-CR1, time to count recovery, and time to CR/CRi. Survival outcomes included relapse-free survival (RFS), overall survival (OS), and estimated 12- and 24-month survival. Data were analyzed with SPSS; pairwise comparisons of medians were performed using Wilcox Sum Rank test, and time to event analyses were performed via the Kaplan-Meier method. Results We identified 68 patients treated with HMA-Ven, 49 of which achieved CR/CRi (53% CR, 19% CRi). 60 of 113 patients (53%) treated with 7+3 achieved CR1 without re-induction, as well as 7 of 14 patients (50%) treated with CPX-351. No patients were enrolled in clinical trials. Of the 7+3 patients who achieved CR1, 14 received additional agents: midostaurin or gemtuzumab. Initial analyses revealed no significant difference between 7+3 and CPX-351 patients in all three primary HRU outcomes (p>0.05). Thus, those patients were analyzed as a single high-intensity treatment group and compared with the lower-intensity HMA-Ven group. Median age for HMA-Ven patients was 72 years, significantly higher than 56 years for the 7+3/CPX group (p<0.001, Table 1). The median days to CR1/CRi was 31 days for the HMA-Ven group and 34 days for the high-intensity group. Patients treated with HMA-Ven required significantly fewer pRBC and Plt units and hospital days than the 7+3/CPX group from start of treatment to CR1 (p<0.001, Table 1). At 60 and 90 days post-CR1, these results were maintained (p≤0.01). Similar results for all three primary outcomes were seen amongst the non-responders of each group with an endpoint of 30 days post-treatment start (p<0.01). Of the HMA-Ven and 7+3/CPX patients, 24% and 63%, respectively, proceeded to HCT. The high-intensity patients who did not receive HCT were placed on midostaurin maintenance or surveillance. There were no significant differences between survival outcomes before adjusting for HCT (p>0.05). The median RFS was 31 months [95% confidence interval (CI), 14-48] for HMA-Ven and 18.1 months [CI, 8.4-28] for 7+3/CPX. Median OS was 33.7 months [CI, 13-55] for HMA-Ven and 74.2 months [CI, 57-85] for 7+3/CPX. Estimated 12- and 24-month RFS was 67% and 60% respectively for HMA-Ven and 67% and 46% for 7+3/CPX. Estimated 12- and 24-month OS was 77% and 62% respectively for the HMA-Ven group and 85% and 70% for 7+3/CPX. After adjusting for HCT, no significant difference was also seen (p>0.05). Conclusion To our knowledge, this is the first assessment of HRU in AML patients treated with HMA-Ven. We found that they required significantly fewer pRBC and Plt transfusions and significantly shorter hospitalizations compared with 7+3 or CPX-351 treated patients, despite a significantly higher median age. These differences were maintained 60- and 90-days post-CR. RFS and OS were not statistically significantly different between treatment regimens. Limitations include the retrospective and single center study design. Our data suggest that HRU should be prospectively evaluated in AML and may be relevant to consider when recommending treatment options. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Open retropubic radical prostatectomy: Still a well-established surgical technique for prostate cancer management

IntroductionThe surgical treatment options for prostate cancer have changed rapidly, given the expansion of robotics. However, open retropubic radical prostatectomy (ORP) will continue to be performed in areas with financial limitations or with limited access to robotics. The purpose of this study was to determine the long-term oncological outcomes, to categorize complication rates and to examine the early continence rates in patients treated with ORP. MethodsWe identified all patients who underwent ORP at our institution between 2000 and 2020. A standardized pad test was used to determine the early continence rates upon catheter removal, the late continence around a year after surgery was determined by the number of pads per day. The Clavien-Dindo classification was used to report the complication rates. The biochemical recurrence (BCR)-free survival and overall survival (OS) rates were defined using the Kaplan–Meier method and log-rank analysis. Multivariable Cox-regression models were used to test the effect of different factors on biochemical recurrence. ResultsWe analyzed 1095 patients. The median follow-up was 93.4 months. An overall 10-year BCR-free survival and OS of 73% and 82% respectively was found. A complication rate for Clavien Dindo≥3 was seen in 4.8% of patients. The early continence rate was 81.4% and the late continence 89,1%. Preoperative PSA level, Gleason score sum, pT stage, lymph node status, and surgical margin status were independent predictors of BCR (p<0.001, 95% CI). Limitations include retrospective and single center study design. ConclusionsORP is a surgical procedure that provides excellent oncological- and early continence-rates.

Effect of perioperative COX-2 and beta-adrenergic inhibition on 5-year disease-free-survival in colorectal cancer: A pilot randomized controlled Colorectal Metastasis PreventIon Trial (COMPIT)

IntroductionBased on translational and epidemiological evidence, perioperative inhibition of beta-adrenergic and COX2 signaling can reduce the risk for post-surgical metastatic disease. Here we aimed to assess in a pilot study the impact of a perioperative combined COX-2 and beta-adrenergic blockade on long-term cancer outcomes in colorectal cancer patients undergoing curative surgery. Materials and methodsThirty-four newly diagnosed colorectal cancer patients without evidence of metastases enrolled in this double-blinded placebo-controlled randomized clinical trial (treatment, n = 16; placebo, n = 18). A 20-day oral treatment of propranolol and etodolac regimen was initiated 5 days before surgery. Beneficial effects on short-term molecular biomarkers of cancer progression were reported earlier. Here we present outcomes of five postoperative years of disease-free-survival and overall survival. ResultsAdverse event rates were equivalent between the two groups. Intent-to-treat analyses of 5-year follow-up showed that 2/16 (12.5%) vs 9/18 (50%) patients exhibited recurrence in treatment vs placebo groups, respectively (p = 0.033), and 2/16 (12.5%) vs 4/18 (22%) died (p = 0.467). In protocol compliant patients 0/11 (0%) vs. 8/17 (47%) exhibited recurrence in treatment vs. placebo groups, respectively (p = 0.007), and 0/11 (0%) and 3/17 (17.6%) died (p = 0.151). ConclusionsIn this pilot clinical trial, a combined perioperative treatment with propranolol and etodolac significantly improved 5-year disease-free-survival. The small sample size and a single center study design merits caution in interpreting these results, specifically in estimating the effect-size. Larger studies in colorectal cancer are warranted and needed.

P08-09 The promotion of walking through nudging. Evaluation of the app „Time2Walk“

BackgroundWalking is an appropriate mode to increase or maintain the physical activity behavior. However, physically inactive adults often need support in order to increase their physical activity level. The aim of the presentation is to inform about the nudging framework within the app Time2Walk, the recruitment of the study participants for both time points, and the development of the walking behavior over time.MethodsThe study participants were recruited via social media, press releases, advertising material and personal contacts. A pre-post single group study design was applied using an online questionnaire before and after the intervention.The intervention refers to a not so distant dystopian future where the city Graz (Austria) suffers from pollution, traffic chaos as well as climate change. Via regular walking as well as visiting places such as parks or other points of interest the users of the app were rewarded with tokens and could contribute to reversing the pollution. Four different types of behavioral nudges were applied during the use of Time2Walk in order to motivate people to walk more: awareness-raising (information about health and traffic related effects), social (information about guided walking tours), rewarding (token-based rewards), and stabilizing (daily walking targets) nudges.The app was developed as a central hub for conveying the nudges and for raising the players' awareness. By means of Wilcoxon-tests, changes in behavior categories were investigated.ResultsThree hundred and forty seven people registered and 145 (42%) filled in the first questionnaire: 65% women, mean age 32 years (SD ±11) and 57% > high-school certificate. Of those, 31 (21%) filled in the the questionnaire a second time. Based on the stages of the Transtheoretical Model as well as on subjective assessment of the weekly walking behavior participants significantly raised their frequency of walking (20% increased walking from 4 or less days/week to ≥ 5 days/week).ConclusionsDifferent interdisciplinary expertise is essential for the development of the app-prototype including the nudging framework. Despite push-notifications, reminders through the newsletter and social media the response rate was low. In general, the nudging framework was successful in the increase of the perceived walking behavior.

Soft collar for acute cervical spine injury immobilisation -patient experiences and outcomes: A single centre mixed methods study

BackgroundCervical collars are used as standard care for neck immobilisation after cervical spine injury. Although evidence for the most effective type of collar is lacking, there is evidence regarding adverse patient outcomes when managed in a semi or rigid collar. In response to the evidence of complications and adverse effects when using a hard collar, a large Australian adult trauma hospital that specializes in spinal care, changed its policy from hard to soft collars when managing acute cervical spine injury. ObjectiveThe aim of this study was to investigate patients’ experiences and outcomes when wearing a soft collar for acute cervical spine injury management in hospital. MethodA single centre mixed method sequential study design was used. ResultsMedical records from 136 patients were examined and no adverse events resulting from collar use were recorded. Interviews with 20 patients revealed that they understood the value of wearing a soft collar. The soft collars were considered supportive and well tolerated, with good adherence to recommendations for use. ConclusionsUnderstanding the patients’ experiences informs better care management. This study suggests that soft collars are well tolerated, do not result in pressure injuries or other adverse events and are suitable for managing acute cervical spine injury.

Frequency of Pregnancy Linked Acute Kidney Damage a Single-Center Study

Background: Acute kidney damage in pregnancy is an unusual but serious complication of pregnancy. Among developed countries, PR-AKI has decreased from 4% to 4.4%. PR-AKI is quite widespread in underdeveloped countries. In impoverished nations like Pakistan, the actual incidence of obstetrics-related AKI and its change are unknown. This research aims to measure acute kidney damage during pregnancy in our setting. Objective: Acute kidney injury (AKI) caused by pregnancy is often documented. To diagnose pregnancy- related AKI. Methods: the study was conducted in the Department of Obstetrics and Gynecology Bacha khan medical college sawabi from 24 June to 24 June 2020. Eighty-seven samples size were included in the study using sequential sample after the areas and (OPD) through A single center study design. The serum creatinine levels were used to diagnose acute renal damage during pregnancy. SPSS version 2.2 for the purpose of data analysis. A mean and standard deviation were determined. for continuous variables such as gestational period, age, and birth weight. Variables like AKI had their frequencies and percentages assessed. The results were then broken down by factors like gestational age and length of pregnancy to determine whether there were any impact modifiers. The significance level was set at P 0.05. Results: The average age of the investigated population was 24 years 2. years old. The pregnancy lasted an average of 3 months, with a standard deviation of 5.112. Acute kidney damage (AKI) was found in only 4% of the 87 individuals investigated, compared to 93% of the patients without AKI. Conclusion: Pregnancy-related acute renal damage was shown to be 7 percent common in our setting, according to the results of our research. Keywords: Creatinine Levels, Pregnancy, Acute Kidney Injury

Survival and tumor characteristics of patients presenting with single primary versus second primary melanoma lesions

Patients with single primary melanomas have an increased risk of developing subsequent melanomas. Secondary tumors diagnosed within and after three months are termed "synchronous" and "asynchronous," respectively. Compare the tumor distributions and survival characteristics of patients with second primary melanoma subtypes to patients with single primary melanomas. Retrospective cohort study. Data were collected from an institutional database from 14,029 patients with a diagnosis of a primary melanoma seen between 1970 and 2004. The synchronous and asynchronous cohorts demonstrated significantly improved survival probabilities compared to the single primary cohort (p=.04 and .002, respectively). Single primaries (2.2mm, SD=2.3) were significantly thicker than the first identified synchronous (2.0mm, SD=1.7) and the first identified asynchronous lesions (1.7mm, SD= 1.3). Synchronous lesions were more likely to be anatomically concordant compared to asynchronous lesions (55.7% vs 38.2%, p<.001). Our limitations include the single center study design as well as incomplete records for second primary melanoma Breslow depth and histopathology. Patients with second primary melanomas demonstrated a significant survival advantage and thinner lesions compared to single primary melanomas. Our reported tumor distributions support the role of FBSE's, with attention to the region of initial diagnosis.

A Single Stage Composite Cleft Septorhinoplasty for Correction of the Mature Unilateral Cleft Nose Deformity - The Gujrat Technique.

To evaluate the results of a single stage composite cleft septorhinoplasty procedure ("The Gujrat Technique") to correct the exaggerated cleft nose deformity after completion of nasal growth in an adult patient cohort. Adult patients with a residual unilateral cleft nasal deformity were deemed eligible for the proposed "Gujrat Technique". Over a 10-year period (2007-2017), 96 adult patients underwent this composite cleft septorhinoplasty as a single stage operation. Post-operative nasal symmetry evaluation was undertaken using the validated computer program 'SymNose'. Functional outcome and patient satisfaction were assessed using Nasal Obstruction Symptom Evaluation scale and Rhinoplasty Outcome Evaluation (ROE) questionnaires respectively. Various statistical analysis methods were used to validate the obtained results. Due to poor compliance with follow-up, post-operative assessments were undertaken in only 32 patients. The single group study design using the non-parametric matching pairs Wilcoxon Sign test (p < 0.001) showed overall good to excellent functional and aesthetic outcomes and higher scores of the digital SymNose grading system. There was a significant improvement in ROE scores (from 26.4 ± 2.9 to 85.9 ± 4.7, p < 0.001). There were no major complications or revisions needed in our series. The individual components of "The Gujrat Technique" are not novel but their combination in this adult unilateral cleft rhinoplasty cohort has demonstrated a high patient satisfaction with its aesthetic appeal and functional versatility. In the background of limited resources and unpredictable patient follow up, the simplicity, reproducibility and cost effectiveness of this technique make it a practical reconstructive option.

An in-depth look at ventilator-associated pneumonia in trauma patients and efforts to increase bundle compliance, education and documentation in a surgical trauma critical care unit

BackgroundVentilator-associated pneumonia (VAP) is considered the most common hospital acquired infection seen in critical care settings and leading cause of death in Intensive Care Units (ICU). The objective of this study was to assess whether specimen collection impacted diagnosis and if implementation of a VAP bundle would decrease rates at our center. MethodsThis single center study design is a retrospective chart review from 2017 to 2020 utilizing the electronic medical record. A pre-/postintervention comparison was performed following implementation of a unit wide VAP bundle and nursing education. Descriptive statistics and continuous variables were analyzed with independent group t -tests, and categorical variables were analyzed with chi-squared tests. ResultsVentilator-associated pneumonia rates decreased in the postimplementation time (20.8%, n = 74 vs 12.2%, n = 15; P = .03). There were no significant differences in the patient profile of those who acquired VAP (ie, males 79.7% vs 86.7%, blunt injuries 63.5% vs 86.7% and severity scores 24.8 vs 25.1, pre vs postimplementation, respectively, all P-values greater than .05). Discussion/ConclusionsReduction in VAP rates were achieved by implementing a standardized, evidence based, prevention protocol. Further research is warranted as studies have noted that patients requiring mechanical ventilation are at greater risk for VAP than other ICU patients due to the nature of their injuries and increased risk of prolonged mechanical ventilation ≥ 21 days.