Clinical Modifications Research Articles

Case Study: Occupational Orthostatic Hypotension in Nepal: Prevalence, Causes, and Management in High-Risk Professions

Orthostatic hypotension (OH) is a condition marked by a significant drop in blood pressure upon standing, resulting from impaired autonomic regulation of vascular tone and blood volume. This study investigates the prevalence, physiological mechanisms, and occupational risk factors for OH among high-risk professions in Nepal, such as traffic police, security guards, and shopkeepers. Using a cross-sectional design, participants were evaluated for blood pressure variability, autonomic function, and fluid balance. The findings reveal a high incidence of OH, linked to reduced baroreceptor sensitivity and impaired sympathetic activation due to prolonged standing and inadequate hydration. This study highlights the need for tailored clinical interventions and workplace modifications to mitigate OH in vulnerable occupational groups.

Superiority of Frailty Over Age in Predicting Outcomes Among Clostridium Difficile Patients: Evidence from National Data

BackgroundClostridium difficile infection (CDI) has become a significant healthcare issue with increasing morbidity and mortality in the US and Europe. Frailty, characterized by reduced physical reserves and resistance to stressors, is linked to poor outcomes but its impact on CDI patients remains underexplored. This study seeks to address this gap through a nationwide analysis. MethodsUsing the National Readmission Database from 2016 to 2020, we employed the International Classification of Diseases, 10th revision, Clinical Modifications codes to identify adult patients admitted with CDI. We further stratified CDI hospitalizations based on frailty. Utilizing a regression model, we assessed the impact of frailty on CDI outcomes. ResultsWe included 144,611 CDI patients of whom 98,167 (67.88%) were frail. Multivariate analysis showed that frail CDI patients had significantly higher mortality (adjusted odds ratio (aOR) 4.87), acute kidney injury requiring dialysis (aOR 9.50), septic shock (aOR 14.23), and intensive care unit admission (aOR 6.80). CDI-specific complications were more likely in frail patients, including toxic megacolon (aOR 10.22), intestinal perforation (aOR 2.30), need for colectomy (aOR 3.90) and CDI recurrence (aOR 3.65). Resource utilization, indicated by hospitalization charges, length of stay, and 30-day readmission rates, was greater among frail patients. ConclusionOur study underscores the significant association between frailty and various critical endpoints of CDI, including its incidence, mortality, and recurrence. Additionally, frailty independently predicts higher resource utilization and elevated 30-day readmission. Recognizing frailty as a determinant of CDI outcomes can aid clinicians in risk stratification and guide tailored interventions for this population.

Unlocking the potential of lumateperone and novel anti-psychotics for schizophrenia

Schizophrenia is a devastating chronic mental health illness which includes a complex set of symptoms like hallucination, illusion and delusion, and to manage, lifelong antipsychotic medications are needed. Schizophrenia affects 1% of the population worldwide, and to date, two different classes of antipsychotics, i.e., typical and atypical antipsychotics, are available in the market, and there is an urgent need for promising antipsychotic drugs. In this review, we focus on recently approved antipsychotics and then focus on different antipsychotic drugs under clinical trials. In this review, we first focus on lumateperone in detail, which was approved in December 2019 by the Food and Drug Administration (FDA) and simultaneously modulates serotonin, glutamate and dopamine neurotransmitters and is used at doses of 10.5-, 21- and 42 mg, which show mild adverse effects like constipation, sedation, somnolence and fatigue. This review also focuses on a few more emerging antipsychotics like brexpiprazole, brilaroxazine, roluperidone, F17464, pimavanserin (ACP-103), xanomeline, BI 409306, BI 425809 and MK-8189 which are under different phase of clinical trials and might get approved soon. Brexpiprazole and brilaroxazine act on dopamine receptors, whereas xanomeline, pimavanserin and roluperidone do not act on D2 receptors and manage the symptoms. All the antipsychotic drugs covered did not show any other severe adverse effects except gastrointestinal issues and cardiometabolic risk factors. However, still rigorous clinical trials and modifications are needed to manage adverse effects, and we can expect a few antipsychotics to be on the market soon.

Cancer Trial Eligibility and Therapy Modifications for Individuals With Duffy Null–Associated Neutrophil Count

Absolute neutrophil counts (ANCs) are used to determine cancer clinical trial (CCT) eligibility and systemic anticancer therapy (SACT) dose modifications. Duffy null-associated ANC (DANC) is a nonpathologic phenotype associated with lower ANC and most frequently seen in individuals with African and Middle Eastern ancestry. It is unclear whether CCTs exclude or SACT regimens modify doses for individuals with ANC within the DANC reference range. To investigate CCT exclusions and SACT dose modifications for ANC within the DANC reference range. This cross-sectional study of contemporary CCTs and SACT regimens included adult, interventional, phase 3 CCTs for the 5 most prevalent cancers in the US and United Kingdom (prostate, breast, melanoma, colorectal, and lung cancers) testing SACTs with start dates between November 1, 2021, and November 1, 2023, and that were registered on ClinicalTrials.gov. Preferred curative-intent SACT regimens were listed in National Comprehensive Cancer Network guidelines. Cancer clinical trial exclusions and SACT regimen modifications. Proportions of CCTs that exclude and SACT regimens that modify doses for individuals with an ANC within the DANC reference range. For CCTs, 289 of 382 trials (75.7%) were eligible, of which 221 (76.5% [95% CI, 71.1%-81.2%]) excluded patients with ANC values within the DANC reference range. Colorectal CCTs had the highest (38 of 44 [86.4% (95% CI, 72.6%-94.8%)]) and prostate CCTs had the lowest (11 of 23 [47.8% (95% CI, 26.8%-69.4%)]) proportions of exclusions. Of CCTs testing cytotoxic chemotherapy, 116 of 142 (81.7% [95% CI, 74.3%-87.7%]) had exclusions; 93 of 123 (75.6% [95% CI, 67.0%-82.9%]) CCTs testing targeted therapies alone and 12 of 24 (50.0% [95% CI, 29.1%-70.9%]) testing hormonal therapies alone had exclusions. Among the 113 US- and UK-based trials, exclusions were present in 89 (78.8% [95% CI, 70.1%-85.9%]). Of 71 SACT regimens, 38 (53.5% [95% CI, 41.3%-65.5%]) included dose modifications for ANC values within the DANC reference range. Lung cancer regimens had the highest (23 of 31 [74.2% (95% CI, 55.4%-88.1%)]) and prostate cancer had the lowest (0 of 12 [0 (95% CI, 0%-26.4%)]) proportions of modifications. Regimens including chemotherapy had modifications in 32 of 44 (72.7% [95% CI, 57.2%-85.0%]); 11 of 20 (55.0% [95% CI, 31.5%-76.9%]) of targeted therapy regimens and 0 of 16 (0% [95% CI, 0%-20.6%]) of hormonal therapy regimens had modifications. Among regimens including chemotherapy and/or targeted therapy, modifications were present in 38 of 55 (69.1% [95% CI, 49.7%-73.2%]). In this cross-sectional study, substantial proportions of CCTs excluded and SACT regimens modified doses for patients with ANCs in the DANC reference range. These practices structurally discriminate against patients of African and Middle Eastern ancestry. While determining optimal SACT dose modifications requires further study, CCT exclusion criteria should be revised.

What Kind of Transformer Models to Use for the ICD-10 Codes Classification Task.

Coding according to the International Classification of Diseases (ICD)-10 and its clinical modifications (CM) is inherently complex and expensive. Natural Language Processing (NLP) assists by simplifying the analysis of unstructured data from electronic health records, thereby facilitating diagnosis coding. This study investigates the suitability of transformer models for ICD-10 classification, considering both encoder and encoder-decoder architectures. The analysis is performed on clinical discharge summaries from the Medical Information Mart for Intensive Care (MIMIC)-IV dataset, which contains an extensive collection of electronic health records. Pre-trained models such as BioBERT, ClinicalBERT, ClinicalLongformer, and ClinicalBigBird are adapted for the coding task, incorporating specific preprocessing techniques to enhance performance. The findings indicate that increasing context length improves accuracy, and that the difference in accuracy between encoder and encoder-decoder models is negligible.

The impact of an aging simulation program for dental students in two community dental clinics.

Clinicians who have not experienced the difficulties that come with aging or disability may be unable to relate to the limitations and experiences of afflicted patients, which is necessary to improve patient-provider connection and treatment outcomes. The purpose of this study was to test the effectiveness of an aging-simulation experience on improving dental students' awareness of aging-related limitations, examine the students' perceptions, and assess planned patient-care modifications based on the aging-simulation experience. A total of 78 dental students who rotated through two extramural clinic sites from August 2021 through October 2022 completed pre-simulation surveys, donned aging simulators in the dental operatory, initiated pre-defined tasks and their corresponding modifications, completed a post-simulation survey, and completed a reflection questionnaire containing structured and open-ended questions. Quantitative responses were analyzed using descriptive frequencies and paired sample t-tests, whereas thematic analyses were used to interpret free-text portion of the reflection questionnaire. Student awareness of the impact of the four aging-related disabilities improved after the experience. Visual impairment was identified as the most difficult symptom to experience during simulation. Students reported increased feelings of empathy and acknowledged the effectiveness of clinical practice modifications to accommodate elderly patients with limitations. Students also expressed intentions to make similar modifications in their future clinical practice and the need for exposure to longer periods of simulated experiences to further clinical practice modifications for elderly patients. The aging-simulation experience is an effective tool for raising dental students' awareness of aging-related difficulties, the need for clinical practice modifications, and increasing empathy.

Generating the evidence to support the establishment of a Respiratory Syncytial Virus surveillance system in Cameroon: A study protocol.

Respiratory syncytial virus (RSV) is one of the major pathogens frequently associated with severe respiratory tract infections in younger children and older adults globally. There is an unmet need with a lack of routine country-specific databases and/or RSV surveillance systems on RSV disease burden among adults in most low- and middle-income countries, including Cameroon. We aim to estimate the adult RSV burden needed to develop a framework for establishing an RSV surveillance database in Cameroon. A two-phase study approach will be implemented, including a literature review and a review of medical records. First, a systematic review of available literature will provide insights into the current burden of RSV in adults in Cameroon, searching the following databases: Global Health, PubMed, CINAHL, Embase, African Journal Online Library, Scopus, Global Index Medicus, Cochrane databases, and grey literature search. Identified studies will be included if they reported on the RSV burden of disease among Cameroonian adults aged ≥18 years from 1st January 1990 to 31st December 2023. A narrative synthesis of the evidence will be provided. A meta-analysis will be conducted using a random effect model, when feasible. Two co-authors will independently perform data screening, extraction, and synthesis and will be reported according to the PRISMA-P guidelines for writing systematic review protocols. Secondly, a retrospective cohort design will permit data analysis on RSV among adults in the laboratory registers at the National Influenza Center. Medical records will be reviewed to link patients' files from emanating hospitals to capture relevant demographic, laboratory, and clinical data. The International Classification of Diseases and Clinical Modifications 10th revision (ICD-10-CM) codes will be used to classify the different RSV outcomes retrospectively. The primary outcome is quantifying the RSV burden among the adult population, which can help inform policy on establishing an RSV surveillance database in Cameroon. The secondary outcomes include (i) estimates of RSV prevalence among Cameroonian adult age groups, (ii) RSV determinants, and (iii) clinical outcomes, including proportions of RSV-associated morbidity and/or death among age-stratified Cameroonian adults with medically attended acute respiratory tract infections. The evidence generated from the two projects will be used for further engagement with relevant stakeholders, including policymakers, clinicians, and researchers, to develop a framework for systematically establishing an RSV surveillance database in Cameroon. This study proposal has been registered (CRD42023460616) with the University of York Center for Reviews and Dissemination of the International Prospective Register of Systematic Reviews (PROSPERO).

Overexpression of zinc finger DHHC-type containing 1 is associated with poor prognosis and cancer cell growth and metastasis in uterine corpus endometrial carcinoma.

The zinc finger DHHC-type containing 1 (ZDHHC1) gene is implicated in the pathogenesis and progression of various malignant tumors, but its precise involvement in uterine corpus endometrial carcinoma (UCEC) remains unknown. Thus, this study investigated ZDHHC1 expression in UCEC using publicly available TCGA and Xena databases and elucidated the functions and mechanisms of the ZDHHC1 gene in UCEC progression using bioinformatics and in vitro experiments. The correlation between ZDHHC1 expression and prognosis, clinical features, immune cells, and RNA modifications of UCEC was evaluated using nomograms, correlation, ROC, and survival analyses. The impacts of ZDHHC1 overexpression on UCEC progression and mechanisms were explored with bioinformatics and in vitro experiments. Our study revealed that ZDHHC1 expression was significantly downregulated in UCEC and correlated with poor prognosis, cancer diagnosis, clinical stage, age, weight, body mass index, histological subtypes, residual tumor, tumor grade, and tumor invasion. Notably, Cox regression analysis and constructed nomograms showed that downregulated ZDHHC1 expression was a prognostic factor associated with poor prognosis in patients with UCEC. Conversely, above-normal ZDHHC1 expression inhibited the cell growth, cell cycle transition, migration, and invasion of UCEC cells, which may be related to the cell cycle, DNA replication, PI3K-AKT, and other pathways that promote tumor progression. Altered ZDHHC1 expression in UCEC was significantly associated with RNA modifications and the changes in cancer immune cell populations, such as CD56 bright NK cells, eosinophils, Th2 cells, and cell markers. In conclusion, considerably reduced ZDHHC1 expression in UCEC is associated with cancer cell growth, metastasis, poor prognosis, immune infiltration, and RNA modifications, revealing the promising potential of ZDHHC1 as a prognostic marker for UCEC.

Research progress on the association between glycemic variability index derived from CGM and cardiovascular disease complications.

Currently, glycated hemoglobin A1c (HbA1c) has been widely used to assess the glycemic control of patients with diabetes. However, HbA1c has certain limitations in describing both short-term and long-term glycemic control. To more accurately evaluate the glycemic control of diabetes patients, the continuous glucose monitoring (CGM) technology has emerged. CGM technology can provide robust data on short-term glycemic control and introduce new monitoring parameters such as time in range, time above range, and time below range as indicators of glycemic fluctuation. These indicators are used to describe the changes in glycemic control after interventions in clinical research or treatment modifications in diabetes patient care. Recent studies both domestically and internationally have shown that these indicators are not only associated with microvascular complications of diabetes mellitus but also closely related to cardiovascular disease complications and prognosis. Therefore, this article aims to comprehensively review the association between CGM-based glycemic parameters and cardiovascular disease complications by analyzing a large number of domestic and international literature. The purpose is to provide scientific evidence and guidance for the standardized application of these indicators in clinical practice, in order to better evaluate the glycemic control of diabetes patients and prevent the occurrence of cardiovascular disease complications. This research will contribute to improving the quality of life for diabetes patients and provide important references for clinical decision-making.

Biomechanical analysis of alveolar bones with compromised quality supporting a 4-unit implant bridge; a possible association with implant-related sequestration (IRS).

This study aimed to investigate the strain in the bone surrounding dental implants supporting a 4-unit bridge and assess the role of excessive strain as a possible risk factor for implant related sequestration (IRS)or peri-implant medication-related osteonecrosis of the jaw (PI-MRONJ). A 3D-mandibular model was constructed using computed tomography and segmented it into cortical and cancellous bones. The 4-unit implant-supported bridges replacing the mandibular posteriors were constructed, and each featuring two, three, and four implants, respectively. The Young's modulus was assigned based on the quality of the bone. A maximum occlusal force of 200N was applied to each implant in the axial and in a 30-degree oblique direction. The maximum principal strain of the fatigue failure range (> 3000 µε) in the bone was analyzed. The volume fraction of fatigue failure was higher in poor-quality bone compared to normal bone and oblique load than in axial load. An increasing number of implants may dissipate excessive strain in poor-quality bones. Occlusal force applied to poor-quality bone can result in microdamage. Given that unrepaired microdamage may initiate medication-related osteonecrosis of the jaw, long-term occlusal force on fragile bones might be a risk factor. When planning implant treatment for patients with compromised bone status, clinical modifications such as strategic placement of implants and optimization of restoration morphology should be considered to reduce excessive strain which might be associated with IRS or PI-MRONJ.

Infusion-Related Reactions Subsequent to Avelumab, Durvalumab, and Atezolizumab Administration: A Retrospective Observational Study.

Avelumab, durvalumab, and atezolizumab are anti-programmed death-ligand 1 (PD-L1) antibodies approved for clinical application in Japan. Despite targeting the same molecule, avelumab elicits a different frequency of infusion-related reactions (IRRs) compared with durvalumab and atezolizumab, leading to differences in premedication recommendations. This study aimed to collect information to verify the relationship during IRRs and the characteristics of antibody molecules, by investigating the frequency of IRRs caused by three types of antibodies and the actual status of prophylactic measures. This single-center, retrospective observational study collected the medical records of 73 patients who received avelumab, durvalumab, or atezolizumab at Osaka University Hospital. The frequency of IRRs was 50.0% (12/24) for avelumab, 31.0% (8/27) for durvalumab, and 18.2% (4/22) for atezolizumab. The IRRs were grade 2 in seven patients and grade 1 in five patients treated with avelumab, grade 2 in six patients and grade 1 in two patients treated with durvalumab, and grade 1 in all patients treated with atezolizumab. Among patients in whom symptoms were observed during the first administration, measures were taken to prevent IRRs for the second administration, but cases were confirmed in which symptoms reappeared, especially in patients who received durvalumab. Our findings indicate that the frequency of IRRs due to anti-PD-L1 antibodies is higher than that previously reported in clinical trials and different modifications in antibody molecules may affect the difference in IRR frequency.

P356 Long-term outcome of UC patients in clinical remission with different level of mucosal activity: real world, retrospective, multicontinental study

Abstract Background In contrast to the increasingly rigorous endpoints of clinical trials of ulcerative colitis (UC), Mayo endoscopic score (MES) ≤ 1 is mostly set as target during clinical follow-up, but long-term outcomes may differ according to different level of healing. Therefore, our study aimed to compare the long-term outcomes of UC patients in clinical remission with different MES and UCEIS scores in real-life condition. Methods UC patients in clinical remission (defined by pMayo<2 with no rectal bleeding) who underwent colonoscopy between 2016-2020 were consecutively enrolled in this multicenter retrospective study. Mayo and UCEIS endoscopic scores were evaluated and clinical and demographic data were collected at baseline. Clinical flare, colectomy, hospitalization and treatment modifications were recorded during at least 3 year of follow-up. Primary outcome was the clinical flare, while secondary outcomes were hospitalization, colectomy, new biological initiation and biological dose escalation during follow-up. Outcomes were compared with Log-rank test and survival characteristics were plotted. Results In total, 156 UC patients were enrolled with a median age of 46.0 (IQR 35.5-58.0), while male/female ratio was 49.4 % (Table 1.). Near to half of the patients (44.9%) had MES>0 endoscopic activity at baseline. Non zero baseline MES (Figure 1.; p = 0.002; MES 0 vs 1 p = 0.004) and UCEIS (p < 0.001; UCEIS 0 vs. 1 p = 0.016) scores were associated with higher rate of clinical flare. Higher baseline MES (p = 0.042) and UCEIS (p = 0.008) scores were coupled with increased risk of hospitalization. Colectomy rates were low. Increased baseline UCEIS (p = 0.003), but not MES score was coupled with new biological treatment initiation, while only UCEIS score was associated with biological treatment intensification (>4; p = 0.008). Conclusion Our study suggests differentiating between complete MH from MES 1 as long-term outcomes were more favorable in case of lower endoscopic scores. Consequently, targeting complete MH should be considered to achieve deep remission and disease clearance.

E-therapists’ views on the acceptability and feasibility of an internet-administered, guided, low-intensity cognitive behavioural therapy intervention for parents of children treated for cancer: A qualitative study

Background Childhood cancer treatment completion can be a period of vulnerability for parents and is associated with mental health difficulties such as depression and anxiety. We developed an internet-administered, guided, low-intensity cognitive behavioural therapy-based self-help intervention (EJDeR) for parents delivered on the U-CARE-portal (Portal). The acceptability and feasibility of EJDeR and study procedures were examined using a single-arm feasibility trial (ENGAGE). Results indicated that EJDeR and ENGAGE study procedures are acceptable and feasible, however, a need for clinical and technical modifications to EJDeR and refinements to ENGAGE study procedures was identified. Objectives This study aimed to explore the acceptability and feasibility of EJDeR and ENGAGE study procedures from the perspective of e-therapists to inform clinical and technical modifications to EJDeR and refinements to study procedures prior to progression to a superiority randomised controlled trial. Methods We conducted semi-structured interviews with 10 e-therapists. Data were analysed using manifest content analysis. Results We identified three categories relating to the acceptability and feasibility of EJDeR: (a) Support to e-therapists (subcategories: Clinical supervision and Technical difficulties); (b) Guidance to parents (subcategories: Support protocols and Synchronous communication); and (c) Content (subcategories: Relevancy of the intervention and Pacing of the intervention). We identified four categories relating to the acceptability and feasibility of study procedures: (a) Recruitment and training of e-therapists (subcategories: Definition of the role and Training program); (b) Retention of parents (subcategories: Parent suitability and screening and Frequency of weekly Portal assessments); (c) Retention of e-therapists (subcategories: Administrative requirements and Communication with the research team); and (d) The Portal. Conclusions EJDeR and study procedures were considered acceptable and feasible, however, clinical and technical modifications and refinements to study procedures were suggested to enhance acceptability and feasibility. Results may also inform implementation considerations for both EJDeR and other similar digital psychological interventions. Trial registration number ISRCTN 57233429

A quasi-experimental study of a bundled diagnostic stewardship intervention for ventilator-associated pneumonia

ObjectivesDiagnostic error in the use of respiratory cultures for ventilator-associated pneumonia (VAP) fuels misdiagnosis and antibiotic overuse within intensive care units. In this prospective quasi-experimental study (NCT05176353), we aimed to evaluate the safety, feasibility, and efficacy of a novel VAP-specific bundled diagnostic stewardship intervention (VAP-DSI) to mitigate VAP over-diagnosis/overtreatment. MethodsWe developed and implemented a VAP-DSI using an interruptive clinical decision support tool and modifications to clinical laboratory workflows. Interventions included gatekeeping access to respiratory culture ordering, preferential use of non-bronchoscopic bronchoalveolar lavage for culture collection, and suppression of culture results for samples with minimal alveolar neutrophilia. Rates of adverse safety outcomes, positive respiratory cultures, and antimicrobial utilization were compared between mechanically ventilated patients (MVPs) in the 1-year post-intervention study cohort (2022–2023) and 5-year pre-intervention MVP controls (2017–2022). ResultsVAP-DSI implementation did not associate with increases in adverse safety outcomes but did associate with a 20% rate reduction in positive respiratory cultures per 1000 MVP days (pre-intervention rate 127 [95% CI: 122–131], post-intervention rate 102 [95% CI: 92–112], p < 0.01). Significant reductions in broad-spectrum antibiotic days of therapy per 1000 MVP days were noted after VAP-DSI implementation (pre-intervention rate 1199 [95% CI: 1177–1205], post-intervention rate 1149 [95% CI: 1116–1184], p 0.03). DiscussionImplementation of a VAP-DSI was safe and associated with significant reductions in rates of positive respiratory cultures and broad-spectrum antimicrobial use. This innovative trial of a VAP-DSI represents a novel avenue for intensive care unit antimicrobial stewardship. Multicentre trials of VAP-DSIs are warranted.

AHP P06 Optimizing Coagulation Screen Practices in CVC Removal Amongst Surgical Patients: A Retrospective Audit Assessing Necessity, Compliance, and Implications

Abstract Background Conflicting findings in recent literature question the significance of traditional coagulation variables in predicting bleeding associated with central venous catheter (CVC) removal. This audit evaluates the necessity and compliance of conducting same-day coagulation screens at Churchill Hospital. The study assesses the practice's relevance, compliance rates, and associated costs, offering implications for clinical decision-making, resource utilization, and potential modifications to current practices. The findings may lead to the adoption of new predictive factors or a targeted approach to coagulation testing, optimizing patient care and resource allocation in CVC removals. Methods This retrospective audit focused on surgical patients in the upper gastrointestinal, hepatobiliary and pancreatic, lower gastrointestinal, and transplant surgery departments at the Churchill Hospital. The study encompassed all instances of central venous catheter (CVC) removal that occurred between January 1st, 2022, and December 31st, 2022. Data retrieval was conducted using electronic patient records, and coagulation test results were interpreted utilizing the reference ranges available in the electronic patient record system (INR 0.9-1.2, PT 9-12, APTT 20-30). Results 78 patients had an average age of 53 years and a mean hospital stay of 35 days. The average duration of CVC in-situ was 8.9 days. Patients underwent an average of 5.07 coagulation tests per stay, equivalent to 0.28 tests per admission day. Among the audited patients (n=67), 41.8% had same-day coagulation screens, 17.9% had the screen one day prior to CVC removal, and 40.3% had the screen more than one day before removal. Analysis showed that 88% had normal INR values, with only eight patients having abnormal values. Furthermore, 74.6% and 58.2% had normal PT and APTT values, respectively. Conclusions This retrospective audit of CVC removals in surgical patients at Churchill Hospital revealed a concerning in-compliance rate of 44% with coagulation screens during CVC removals. Most patients had normal coagulation parameters, questioning the need for same-day screens. Delays and high costs (£64.76 per patient, £12.95 per screen) were incurred. Individualized risk-based approach, considering bleeding history, could be more efficient. Implementing targeted coagulation testing saves costs and optimizes resource utilization. Further evaluation required to improve patient care and resource allocation in CVC removals, reducing reliance on routine same-day screens.

Reverse Sural Artery Flap: Anatomic Study of Peroneal Perforators and Clinical Modifications for Coverage of Medial and Distal Foot Defects

Reverse Sural Artery Flap: Anatomic Study of Peroneal Perforators and Clinical Modifications for Coverage of Medial and Distal Foot Defects

Patients with fibromyalgia in Finnish healthcare center – one-year follow up

Objectives The study aimed to find whether Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ) predicts the severity of fibromyalgia symptoms after one year in patients with fibromyalgia. The second aim of the study was to observe how symptoms evolved during a one-year follow-up. Design Prospective cohort and observational study. Five questionnaires were sent to patients. The same questionnaires (excluding ÖMPSQ) were sent after one year. The patients were allocated into two cohorts using the results of ÖMPSQ. Other variables were analyzed and observed separately. Setting Primary healthcare center in the city of Nokia, Pirkanmaa, Finland Subjects Patients with fibromyalgia were included in the study after a physician’s examination and confirmation of diagnosis with the assistance of the American College of Rheumatology (ACR) 2010 criteria. Main outcome measures Fibromyalgia impact questionnaire (FIQ) scores Results The FIQ scores increased slightly in both ÖMPSQ-cohorts with no statistically significant differences. The patients mostly reported that the symptoms were unchanged or got worse when asked separately from other questionnaires. There was a statistically significant decrease in PHQ-9 score in depressed patients who received antidepressants and/or psychological therapy. In addition, FIQ scores also decreased in depressed patients. Patients who received alterations to the treatment plan reported positive changes in the symptoms more often. Conclusion With these results, we cannot conclude that ÖMPSQ predicts the patient’s severity of symptoms. On the contrary, we can conclude that antidepressants and/or psychological therapy might reduce fibromyalgia symptoms for depressed patients with fibromyalgia. Patients with fibromyalgia might benefit from clinical evaluation and modifications to the treatment plan if necessary.

Development and electronic health record validation of an algorithm for identifying patients with Duchenne muscular dystrophy in US administrative claims.

BACKGROUND: Muscular dystrophies (MDs) comprise a heterogenous group of genetically inherited conditions characterized by progressive muscle weakness and increasing disability. The lack of separate diagnosis codes for Duchenne MD (DMD) and Becker MD, 2 of the most common forms of MD, has limited the conduct of DMD-specific real-world studies. OBJECTIVE: To develop and validate administrative claims-based algorithms for identifying patients with DMD and capturing their nonambulatory and ventilation-dependent status. METHODS: This was a retrospective cohort study using the statistically deidentified Optum Market Clarity Database (including patient claims linked with electronic health records [EHRs] data) to develop and validate the following algorithms: DMD diagnosis, nonambulatory status, and ventilation-dependent status. The initial study sample consisted of US patients in the database who had a diagnosis code for Duchenne/Becker MD (DBMD) between October 1, 2018, and September 30, 2020, who were male, aged 40 years or younger on their first DBMD diagnosis, and met continuous enrollment and 1-day minimal clinical activities requirement in a 12-month measurement period between October 1, 2017, and September 30, 2020. The algorithms, developed by a cross-functional team of DMD specialists (including patient advocates), were based on administrative claims data with International Classification of Diseases, Tenth Revision, Clinical Modifications coding, using information of diagnosis codes for DBMD, sex, age, treatment, and disease severity (eg, evidence of ambulation assistance/support and/or evidence of ventilation support or dependence). Patients who met each algorithm and had EHR notes available were then validated against structured fields and unstructured provider notes from their own linked EHR to confirm patients' DMD diagnoses, nonambulatory status, and ventilation-dependent status. Algorithm performance was assessed by positive predictive value with 95% CIs. RESULTS: A total of 1,300 patients were included in the initial study sample. Of these, EHR were available and reviewed for 303 patients. The mean age of the 303 patients was 14.8 years, with 61.7% being non-Hispanic White. A majority had a Charlson comorbidity index score of 0 (59.4%) or 1-2 (27.7%). Positive predictive value (95% CI) was 91.6% (85.8%-95.6%) for the DMD diagnosis algorithm, 88.4% (80.2%-94.1%) for the nonambulatory status algorithm, and 77.8% (62.9%-88.8%) for the ventilation-dependent status algorithm. CONCLUSIONS: This work provides the means to more accurately identify patients with DMD from administrative claims data without a specific diagnosis code. The algorithms validated in this study can be applied to assess treatment effectiveness and other outcomes among patients with DMD treated in clinical practice. DISCLOSURES: This study was funded by Pfizer, which contracted with Optum to perform the study and provide medical writing assistance. Ms Schrader reports being an employee of Parent Project Muscular Dystrophy. Mr Posner reports being an employee and stockholder of Pfizer and receiving support from Pfizer for attending conferences not related to this manuscript. Dr Dorling reports being an employee and stockholder of Pfizer at the time the study was conducted and is a current employee of Chiesi USA, Inc. Ms Senerchia reports being an employee of Optum and owning stock in Pfizer and UnitedHealth Group, the parent company of Optum. Dr Chen reports being an employee and stockholder of Pfizer. Ms Beaverson reports being an employee of Pfizer and owning stock in Pfizer and Amicus Therapeutics. Dr Seare reports being an employee of Optum at the time the study was conducted. Dr Garnier and Ms Merla report being employees of Pfizer. Ms Walker reports being an employee of Optum. Dr Alvir reports being an employee and stockholder of Pfizer. Dr Mahn reports being an employee and stockholder of Pfizer. Dr Zhang reports being an employee of Optum. Ms Landis reports being an employee of Optum. Ms Buikema reports being an employee of Optum and holding stock in UnitedHealth Group, the parent company of Optum.

The Association Between Thyroid Stimulating Hormone and Depression: A Historical Cohort Study

ObjectiveTo investigate the association between thyroid-stimulating hormone (TSH) and clinically relevant depression (CRD) in a population-based study. Patients and MethodsAdult patients (≥18 years of age) who received care at Mayo Clinic in Rochester, Minnesota, and completed a TSH and Patient Health Questionnaire - 9 (PHQ-9) within 6 months of each other, between July 8, 2017, and August 31, 2021, were included. Demographics, medical comorbidities, thyroid function laboratory data, psychotropic medications, presence of primary thyroid disorder, thyroid hormone replacement (T4 and/or T3), and mood disorder diagnoses (using International Classification of Diseases, 10th version, Clinical Modifications codes) were extracted electronically. The primary outcome, CRD, was defined as a PHQ-9 score greater than or equal to 10. Logistic regression analysis was conducted to assess the association between TSH categories (low ≤0.3 mIU/L; normal >0.3-4.2 mIU/L; high >4.2 mIU/L) and CRD. ResultsThe cohort included 29,034 patients, mean age 51.4 years, 65% females, 89.9% White, and a mean body mass index of 29.9 kg/m2. The mean ± standard deviation for TSH was 3.0±8.5 mIU/L, and the mean PHQ-9 score was 6.3±6.2. After adjustment, the odds of CRD were significantly higher among the low TSH category (odds ratio, 1.37; 95% CI, 1.18-1.57; P<.001) compared with the normal TSH category, especially in people 70 years of age or younger compared with people older than 70 years of age. Subgroup analysis did not show an increase in odds of CRD among patients with subclinical/overt hypothyroidism/hyperthyroidism (after adjustment). ConclusionIn this large population-based cross-sectional study, we report that low TSH was associated with higher odds of depression. Future longitudinal cohort studies are needed to investigate the relationship between thyroid dysfunction and depression as well as sex differences.

POLYGENIC RISK SCORES AND THEIR PHENOTYPIC ADJUSTMENT: NOVEL BIOMARKERS IN CARDIOVASCULAR DISEASE PREVENTION

Objective: This study aimed to develop a novel genetic tool, the Polygenic Risk Score (PRS), to non-invasively and routinely estimate predisposition to cardiovascular diseases (CVDs), comprising coronary artery disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, atrial fibrillation, ischemic stroke, and heart failure. The study also aimed to improve risk estimation by incorporating chronological age, physiological characteristics, and behavioral parameters to calculate an adjusted PRS. Design and method: Three algorithms were designed to i) search literature databases for GWAS on CVD predisposition, ii) derive Single Nucleotide Polymorphisms (SNPs) by assessing p-values, beta coefficients, odds ratios, and linkage disequilibrium metrics, and then iii) calculate the PRS for each CVD. Manual scientific evaluation was also employed. Thus, a novel genetic panel (termed iDNA Cardio Health) was developed to assess polygenic risk for the six above mentioned CVDs, following buccal swab sampling. Finally, we employed the American Heart Association's (AHA) Life's Simple 7 (LS7) lifestyle and phenotypic characteristics scoring system to assess current cardiovascular health status and then use this information, as well as chronological age, to dynamically calculate an adjusted PRS. Results: After testing the iDNA Cardio Health on a Greek population sample, we were capable to examine CVD risk stratification. Additionally, we could identify individuals with high polygenic risk, who could significantly benefit from lifestyle and/or clinical modifications. Furthermore, employing the LS7 categorization, we were capable to fine-tune risk prediction based on the adjusted PRS. Conclusions: It is evident that current clinical tools for CVD risk estimation may underestimate the risk, while the PRS can be employed to optimally reclassify individuals with marginal intermediate risk to a high-risk category. Our novel methodology, which at its core encompasses polygenic risk, can be combined with LS7 traditional clinical risk prediction metrics and chronological age to revolutionize CVD prevention though screening, monitoring, and clinical management, thus enabling the implementation of PRS and adjusted PRS in clinical care to empower personalized medicine.