Review Committee Research Articles

Belzutifan for von Hippel-Lindau Disease: Pancreatic Lesion Population of the Phase 2 LITESPARK-004 Study.

Primary analysis of the ongoing, single-arm, phase 2 LITESPARK-004 study (NCT03401788) showed clinically meaningful antitumor activity in von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) and other neoplasms with belzutifan treatment. We describe results of belzutifan treatment for VHL disease-associated pancreatic lesions [pancreatic neuroendocrine tumors (pNET) and serous cystadenomas]. Adults with VHL diagnosis based on germline VHL alteration, ≥1 measurable RCC tumor, no renal tumor >3 cm or other VHL neoplasm requiring immediate surgery, Eastern Cooperative Oncology Group performance status of 0 or 1, and no prior systemic anticancer treatment received belzutifan 120 mg once daily. End points included objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and linear growth rate (LGR) in all pancreatic lesions and pNETs per RECIST version 1.1 by independent review committee, and safety. All 61 enrolled patients (100%) had ≥1 pancreatic lesion and 22 (36%) had ≥1 pNET measurable at baseline. Median follow-up was 37.8 months (range, 36.1-46.1). ORR was 84% [51/61; 17 complete responses (CR)] in pancreatic lesions and 91% (20/22; 7 CRs) in pNETs. Median DOR and median PFS were not reached in pancreatic lesions or pNETs. After starting treatment, median LGR for pNETs was -4.2 mm per year (range, -7.9 to -0.8). Eleven patients (18%) had ≥1 grade 3 treatment-related adverse event (AE). No grade 4 or 5 treatment-related AEs occurred. Belzutifan continued to show robust activity and manageable safety in VHL disease-associated pNETs.

Diagnostic Accuracy of Narrow-Band Imaging in Predicting Helicobacter pylori Gastritis in Patients With Dyspepsia.

Background Helicobacter pylori (H. pylori) is one of the most prevalent causes of chronic gastritis that can lead to gastric cancer if left untreated. Currently, endoscopy and histology are the gold standard tests for the diagnosis of H. pylori gastritis. Recently, studies have shown the utility of narrow-band imaging (NBI) in predicting H. pylori gastritis. Therefore, we aimed to determine the diagnostic accuracy of NBI in predicting H. pylori gastritis in patients with dyspepsia. Methodology After obtaining approval from the Ethical Review Committee, Sindh Institute of Urology and Transplantation, this cross-sectional study was conducted in the outpatient Clinic of Hepatogastroenterology of the institute. Inclusion criteria involved all patients of either gender aged 18 to 65 years with dyspeptic symptoms. We excluded patients with a history of proton pump inhibitor use within two weeks before endoscopy, heart failure, previous gastrectomy, portal gastropathy, cirrhosis, use of antiplatelet medications, non-steroidal anti-inflammatory drugs or anticoagulant medication, and hemorrhagic or thrombophilia disorders. Each patient underwent endoscopy-guided NBI studies followed by biopsies from the antrum and body of the stomach. Multivariate logistic regression analysis was performed for the type of NBI pattern predicting H. pylori infection. The diagnostic accuracy was obtained individually for each NBI type and then for the presence of either two or all three NBI types in predicting H. pylori gastritis. Results Out of the total 775 patients enrolled in the study, abnormal NBI patterns were observed in 401 (51.7%) patients. The presence of abnormal NBI antral mucosal pattern on endoscopy was significantly associated with H. pylori infection (p < 0.001) with excellent diagnostic accuracy. Among the three NBI types, individually, NBI type III had excellent specificity and better diagnostic accuracy in predicting H. pylori gastritis than the other two types. Furthermore, the presence of all three abnormal NBI patterns (I+II+III) together was significantly associated with the presence of H. pylori gastritis with a sensitivity of 94.54%, specificity of 86.55%, and diagnostic accuracy of 90.32%. Conclusions NBI on endoscopy shows excellent diagnostic accuracy in identifying H. pylori gastritis in patients with dyspepsia. However, multicenter studies are required not only to validate our results but also to predict the pre-cancerous lesions on NBI in patients with H. pylori gastritis.

Prevalence of Musculoskeletal Disorders among Painters- A Cross Sectional Study

ABSTRACT Background: Musculoskeletal disorders are considered to be one of the major sources of discomfort and pain among painters. This is due the poor ergonomics and bad posture assumed during the working hours. Objective: To determine the prevalence of Musculoskeletal disorders (MSDs) among painters. Methodology: It was cross sectional study conducted among the painters from Lahore and Sialkot after ethical approval from the Institutional Ethical Review Committee of Superior College Lahore. A sample of n= 282 painters with age ranging from 18 to 45 years was included in the study. A pre-determined validated Nordic Musculoskeletal Questionnaire (NMQ) was used to assess for MSDs. SPSS version V.22 was used and frequencies were calculated. Result: There were n=282 painters, among them the study comprised of n=111 (39.4%) male and n=171(60.5%) female painters with mean age of 26.69±5.57 years. There were n=168(59.6%) had discomfort or pain in shoulder in last 12 months. While n=227 (80.5%) had discomfort in neck in last 7 days. On upper back, n=202(71.6%) had discomfort or numbness in last 12 months while n=216(76.6%) had discomfort in last 7 days. Conclusion: This study concluded that neck is the most affected region among the painters followed by the upper back and shoulder region. Key Words: Musculoskeletal disorders, Nordic Musculoskeletal Questionnaire (NMQ), Pain, Painters, Prevalence

Challenges of Measuring Self-Reported Exposure to Occupational Biomechanical Risk Factors Amongst People with Low Literacy Engaged in Manual Labour: Findings from a Cross-Cultural Adaptation and Psychometric Investigation in an African Population with Chronic Low Back Pain

PurposeOccupational biomechanical factors are implicated in the aetiology and progression of low back pain (LBP). This study cross-culturally adapted and psychometrically investigated the Occupational Risk Factor Questionnaire (ORFQ) in a low literate Nigerian Igbo population with chronic LBP.MethodsForward and back translation of the original ORFQ by clinical and non-clinical translators was followed by an expert committee review. The adapted ORFQ was pre-tested amongst rural Nigerian adults with chronic LBP using cognitive think-aloud interviewing. Internal consistency (Cronbach’s alpha) and test–retest reliability (unweighted and linear weighted k statistic for item-by-item agreement, and intra-class correlation coefficient—ICC) were investigated amongst 50 rural and urban Nigerian dwellers with chronic LBP. Spearman’s correlation and regression analyses were conducted with the Igbo-ORFQ, and measures of disability [World Health Organisation Disability Assessment Schedule (WHODAS 2.0), Roland Morris Disability Questionnaire (RMDQ), Back performance scale (BPS)], pain intensity [Eleven-point box scale (BS-11)] and social support [Multidimensional Scale of Perceived Social Support (MSPSS)], to test construct validity with 200 rural Nigerian dwellers with chronic LBP.ResultsCross-cultural adaptation highlighted difficulty conceptualising and concretising exposure to biomechanical risk factors. Item-by-item agreement, internal consistency (α = 0.84) and intraclass correlation coefficient (ICC = 0.83) were good. Some unexpected direction of associations between the biomechanical components of the Igbo-ORFQ, and disability, pain intensity, and social support prohibits establishment of construct validity.ConclusionProspective studies comparing the Igbo-ORFQ to other measures of exposure to occupational biomechanical risk factors are required to establish the construct validity of the Igbo-ORFQ.

Depression and anxiety among cancer patients visiting a tertiary care cancer hospital.

Cancer patients frequently experience psychological problems related to reactions to cancer diagnosis, cancer type and stage, treatment effects, recurrence, fear of end-of-life, survivorship, and financial burden. Depression and anxiety are both psychological and physiological disturbances among cancer patients. To assess the prevalence of depression and anxiety among cancer patients attending a tertiary care cancer hospital. A cross-sectional study was conducted at Bhaktapur Cancer Hospital in Kathmandu Valley among 220 cancer patients aged from 18 years to 70 years. Ethical approval was taken from the Institutional Review Committee of CiST College. Convenient sampling was used to interview patients with the standardized Patient-Health Questionnaire (PHQ-9) for Depression and Hospital Anxiety and Depression sub-scale (HADS-A) for anxiety. Epi-Data was used for data entry and transferred to SPSS Version 25 for analysis. The study revealed that of 220 patients, most of the respondents belonged to the age group 51-60 years. More than half 131 (59.6%) of the respondents were female, most of them had depression, and one-third had anxiety. Among the respondents, 124 (56.4%) had mild depression, 70 (31.8%) had moderate depression, and 3 (1.3%) had severe depression; 79 (35.9%) had mild anxiety, 64 (29.1%) had moderate anxiety, and 4 (1.8%) had severe anxiety. Most respondents were depressed and one-third had anxiety. More than half and nearly one-third had mild and moderate depression, respectively, and nearly one-third had mild and moderate anxiety, which is higher than other studies.

UPTAKE AND OUTCOMES OF MILD OVARIAN STIMULATION FOR IN-VITRO FERTILIZATION IN AFRICA: A SYSTEMATIC REVIEW

Introduction: Assisted Reproductive Technology (ART) is beyond the economic reach of most of those inflicted by infertility in Africa. Uptake of low-cost in-vitro fertilization (LCIVF) may improve financial access of patients to advanced fertility care.&#x0D; Methodology: Systematic review of open-access full articles published in English from January 2000 to May 2023. Articles were sourced via PubMed, Medline, Embase and Google Scholar databases on June 1st 2023. Search keywords used were “Mild stimulation” OR “Low-cost IVF” AND “Africa”.&#x0D; Ethics: This project was subjected to Ethics review by the University of South Wales Ethics review Committee.&#x0D; Results: 5 publications included out of 647 results. These were historical reports in contextualized narrative reviews with no statistics provided. Because of this, only qualitative synthesis was undertaken, and meta-analysis was not possible due to lack of statistics for comparison. Published results indicated significant financial restriction of access and no objective demonstration of actual uptake and outcomes of mild ovarian stimulation in Africa.&#x0D; Discussion: There was no actual open-access published evidence regarding uptake of mild stimulation for low-cost IVF in Africa. If there is such material, it is not available to those that would actually need the information to inform providers’ practice or patient choices. This is the case despite growing evidence of increasing utility of LCIVF outside Africa. Uptake of LCIVF may potentially ameliorate financial restrictions of access to ART in Africa.

A114 IMPROVING THE QUALITY OF PARACENTESIS PRACTICES IN PEOPLE WITH ADVANCED CIRRHOSIS IN AN AMBULATORY CARE SETTING

Abstract Background Spontaneous bacterial peritonitis (SBP) is a lethal complication of decompensated cirrhosis carrying a 90% mortality rate when left untreated. Despite AASLD recommendations, there is a practice gap regarding fluid cell count (FCC) collection during paracentesis. Aims We initiated prospective quality improvement (QI) project to improve FCC collection in an ambulatory care setting from a baseline of 78% to a goal of 100% compliance between September 11, 2022 and April 17, 2023. Methods We examined the effects of a quality improvement initiative in 233 adult patient encounters with cirrhosis undergoing paracentesis in an ambulatory setting located within a quaternary care centre in Toronto, Canada within the study timeframe. Using a multidisciplinary approach, the quality improvement initiatives included focused groups, education regarding AASLD guidelines, development of a paracentesis bundle, and streamlining workflow process. Descriptive statistics were collected. Statistical analysis using run charts and p-charts were conducted using QI Macros. Approval was obtained from the QI Review Committee at the institution where this QI initiative took place. Results Baseline adherence for collecting ascitic FCC per paracentesis procedure was 78%. Inconsistencies during process mapping such as variations in documentation, printing FCC labels and consistency in FCC collection were identified as root causes. Thus, bedside paracentesis bundles were introduced to standardize process and improve workflow. Post-intervention, the FCC rate increased marginally to 79.6% with no special cause variation identified (Figure 1). Subgroup analysis demonstrated FCC collection rates of 100% amongst registered nurse (RN) and nurse practitioners (NP), 97% amongst resident physicians, and 92% amongst attending physicians. Subsequently, another subgroup analysis was completed demonstrating 97% FCC collection rate amongst general hepatology group, while 40% FCC rate amongst specialty hepatology group. Overall rate of SBP was 1.62% (N=3). Conclusions This prospective QI study revealed a gap in guidance pertaining to the role of ascitic fluid cell count collection in patients with cirrhosis undergoing paracentesis in ambulatory settings. Further studies ascertaining rationale for not sending FCC may be helpful in elucidating why there is a gap in clinical practice. Additionally conducting studies in ambulatory settings to assess FCC collection's impact on morbidity and mortality will provide vital evidence and clarity for the role of FCC in this vulnerable patient group. Figure 1: P-chart demonstrating percentage FCC Collection per week from September 11, 2022 to April 17, 2023. UCL indicates upper control limit; CL, center line; LCL, lower Control Limit. Funding Agencies Toronto Centre for Liver Disease funded the MSc QI program for Mary Sedarous (writer) who completed this study as her MSc QI project.

Quality improvement project to reduce medicare 1-day write-offs due to inappropriate admission orders

BackgroundWe identified that Stanford Health Care had a significant number of patients who after discharge are found by the utilization review committee not to meet Center for Mediare and Medicaid Services (CMS) 2-midnight benchmark for inpatient status. Some of the charges incurred during the care of these patients are written-off and known as Medicare 1-day write-offs. This study which aims to evaluate the use of a Best Practice Alert (BPA) feature on the electronic medical record, EPIC, to ensure appropriate designation of a patient’s hospitalization status as either inpatient or outpatient in accordance with Center for Medicare and Medicaid services (CMS) 2 midnight length of stay benchmark thereby reducing the number of associated write-offs.MethodWe incorporated a best practice alert (BPA) into the Epic Electronic Medical Record (EMR) that would prompt the discharging provider and the case manager to review the patients’ inpatient designation prior to discharge and change the patient’s designation to observation when deemed appropriate. Patients who met the inclusion criteria (Patients must have Medicare fee-for-service insurance, inpatient length of stay (LOS) less than 2 midnights, inpatient designation as hospitalization status at time of discharge, was hospitalized to an acute level of care and belonged to one of 37 listed hospital services at the time of signing of the discharge order) were randomized to have the BPA either silent or active over a three-month period from July 18, 2019, to October 18, 2019.ResultA total of 88 patients were included in this study: 40 in the control arm and 48 in the intervention arm. In the intervention arm, 8 (8/48, 16.7%) had an inpatient status designation despite potentially meeting Medicare guidelines for an observation stay, comparing to 23 patients (23/40, 57.5%) patients in the control group (p = 0.001). The estimated number of write-offs in the control arm was 17 (73.9%, out of 23 inpatient patients) while in the intervention arm was 1 (12.5%, out of 8 inpatient patient) after accounting for patients who may have met inpatient criteria for other reasons based on case manager note review.ConclusionThis is the first time to our knowledge that a BPA has been used in this manner to reduce the number of Medicare 1-day write-offs.

DIETARY ADHERENCE COMPONENT OF END-STAGE RENAL DISEASE ADHERENCE QUESTIONNAIRE (ESRD-AQ): TRANSLATION AND VALIDATION

Introduction: A nutritionally balanced diet is crucial among end-stage renal disease (ESRD) patients to maintain their health status. An appropriate instrument is needed to assess ESRD patients’ adherence towards dietary recommendations. Several questionnaires to measure adherence behaviours of ESRD patients are available but none has ever been translated into the Malay language. Therefore, this study aimed to translate the End-stage Renal Disease Adherence Questionnaire (ESRD-AQ), focusing on the dietary adherence component, from English to Malay. Methodology: Forward and backward translations of the questionnaire were done involving experts in dietetics and linguistics to produce a pre-harmonized Malay translation and two backward English translations according to established guidelines. An expert committee reviewed these translated questionnaires to produce a harmonized version. This then underwent a pre-test and cognitive interview, as well as face validity assessment, involving 15 hemodialysis patients. The Cronbach’s alpha was also analyzed to assess the internal consistency of the questionnaire. Results: Minor amendments were made to several phrases during the expert committee review to ensure the translated questionnaire was contextually appropriate and culturally adapted in Malay language. All questions in the Malay version of ESRD-AQ achieved a Face Validity Index (FVI) value of 1.00, indicating high validity. Additionally, the questionnaire produced a Cronbach's alpha value of 0.84, which is within the acceptable range. Conclusion: The Malay version of ESRD-AQ (Dietary Adherence Component) underwent translation and validation protocols, the findings of which indicate that it is clear, comprehensible, and reliable for use in assessing dietary adherence among ESRD patients in Malaysia.

A pivotal bridging study of lurbinectedin as second-line therapy in Chinese patients with small cell lung cancer

This single-arm, multi-center clinical trial aimed to evaluate the safety, tolerability, DLT, recommended dose (RD), preliminary efficacy, and pharmacokinetics (PK) characteristics of lurbinectedin, a selective inhibitor of oncogenic transcription, in Chinese patients with advanced solid tumors, including relapsed SCLC. Patients with advanced solid tumors were recruited in the dose-escalation stage and received lurbinectedin in a 3 + 3 design (two cohorts: 2.5 mg/m2 and 3.2 mg/m2, IV, q3wk). The RD was expanded in the following dose-expansion stage, including relapsed SCLC patients after first-line platinum-based chemotherapy. The primary endpoints included safety profile, tolerability, DLT, RD, and preliminary efficacy profile, while the secondary endpoints included PK characteristics. In the dose-escalation stage, ten patients were included, while one patient had DLT in the 3.2 mg/m2 cohort, which was also the RD for the dose-expansion stage. At cutoff (May 31, 2022), 22 SCLC patients were treated in the ongoing dose-expansion stage, and the median follow-up was 8.1 months (range 3.0–11.7). The most common grade ≥ 3 treatment-related adverse events (TRAEs) included neutropenia (77.3%), leukopenia (63.6%), thrombocytopenia (40.9%), anemia (18.2%), and ALT increased (18.2%). The most common severe adverse events (SAEs) included neutropenia (27.3%), leukopenia (22.7%), thrombocytopenia (18.2%), and vomiting (9.1%). No treatment-related deaths occurred. The Independent Review Committee (IRC)-assessed ORR was 45.5% (95% CI 26.9–65.3). Lurbinectedin at the RD (3.2 mg/m2) showed manageable safety and acceptable tolerability in Chinese patients with advanced solid tumors, and demonstrates promising efficacy in Chinese patients with SCLC as second-line therapy.Trial registration: This study was registered with ClinicalTrials.gov NCT04638491, 20/11/2020.

Blue Sky Thinking: Physician Assistant Accreditation and the Potential Impact on the Programs, Faculty, and the Profession.

Blue sky thinking references the opportunity to brainstorm about a topic without limits… to consider what things might be like if creative thoughts were unconstrained by current philosophies or other boundaries. This article is a call to our fellow educators to consider how blue sky thinking applied to physician assistant (PA) program accreditation might further advance programs, faculty, and the profession. To develop and maintain a PA program, institutions must voluntarily undergo evaluation by the Accreditation Review Commission on Education for the Physician Assistant. Compliance with accreditation encourages sound educational practices, promotes program self-study, stimulates innovation, maintains confidence with the public, and focuses on continuous quality improvement. In addition, accreditation "can hold institutions accountable for desired outcomes and professional standards." Indeed, while the PA profession has promulgated across the globe, the 50+ years of graduating PAs educated with the highest quality education assures that the United States remains a gold standard. As the 5th edition of the standards are implemented and planning for the 6th edition is underway, in the spirit of continuous quality improvement, we encourage stakeholders of the PA profession to contemplate ways in which accreditation might continue to purposefully advance a desired future state for the profession. In this article, we draw on examples from other health professions which might inform a discussion around the future of PA accreditation. Specifically, the topics of a unified profession title and degree, a specific title and position for program leadership, a modification to how PA programs receive medical direction, and efforts to advance scholarship are addressed.

Protocol of a first-in-human clinical trial to evaluate the safety, tolerability, and preliminary efficacy of the bispecific CD276xCD3 antibody CC-3 in patients with colorectal cancer (CoRe_CC-3).

Colorectal cancer (CRC) is the third most common cancer worldwide in men and women. In the metastasized stage, treatment options and prognosis are limited. To address the high medical need of this patient population, we generated a CD276xCD3 bispecific antibody termed CC-3. CD276 is expressed on CRC cells and on tumor vessels, thereby allowing for a "dual" anticancer effect. This first-in-human clinical study is planned as a prospective multicenter trial, enrolling patients with metastatic CRC after three lines of therapy. During the dose-escalation part, initially, an accelerated titration design with single-patient cohorts is employed. Here, each patient will receive a fixed dose level (starting with 50 µg for the first patient); however, between patients, dose level may be increased by up to 100%, depending on the decision of a safety review committee. Upon occurrence of any adverse events (AEs) grade ≥2, dose-limiting toxicity (DLT), or reaching a dose level of ≥800 µg, the escalation will switch to a standard 3 + 3 dose design. After maximum tolerated dose (MTD) has been determined, defined as no more than one of the six patients experiencing DLT, an additional 14 patients receive CC-3 at the MTD level in the dose-expansion phase. Primary endpoints are incidence and severity of AEs, as well as the best objective response to the treatment according to response evaluation criteria in solid tumors (RECIST) 1.1. Secondary endpoints include overall safety, efficacy, survival, quality of life, and pharmacokinetic investigations. The CD276xCD3 study was approved by the Ethics Committee of the Medical Faculty of the Heinrich Heine University Düsseldorf and the Paul-Ehrlich-Institut (P00702). Clinical trial results will be published in peer-reviewed journals. Trial registration numbers: ClinicalTrials.cov Registry (NCT05999396) and EU ClinicalTrials Registry (EU trial number 2022-503084-15-00).

Management of bipolar disorder in South Africa: National Department of Health essential medicine selection and treatment algorithms

Background. Bipolar disorder (BD) is a severe mental illness associated with multimorbidity, psychosocial disability and significant public health issues. However, guideline heterogeneity clouds therapeutic decisions, particularly in relapse prevention. Polypharmacy and poor health outcomes are common. For low- and middle-income countries, deciding which medicines to procure and how to treat BD in an integrated manner remains elusive. Although South Africa (SA) is committed to universal health coverage, the estimated treatment gap for mental disorders in the public health sector is 91%. An Essential Medicines List (EML) enables equitable access to medicines, while Standard Treatment Guidelines (STGs) facilitate rational prescribing and quality care. Objectives. To describe the medicine selection process for the treatment of BD in the SA public health sector, and the treatment algorithms developed to guide integrated care. Methods. Evidence-based medicine principles, stakeholder consultation and consensus decision-making were used. The existing (2015) BD guideline and stakeholder comments were reviewed by a ministerially appointed expert review committee, following which a research question with eligibility criteria was formed, and rapid systematic evidence synthesis conducted. PubMed and Cochrane databases were searched for systematic reviews of randomised controlled trials and observational studies of acute and maintenance treatment in BD, with an additional PubMed search for primary research. Quality of the systematic reviews was appraised using the 11-item assessment of multiple systematic reviews. After costing to ensure affordability, final recommendations were made to the National EML Committee (NEMLC) using the strength of recommendation taxonomy classification. Following approval by the NEMLC, proposed medicines were incorporated into the 2019 National Department of Health Adult Hospital STGs. As the STGs are updated every 3 years, stakeholder input was sought in 2021 and 2023, with no changes to the medicine selection. Results. Seven systematic reviews and one observational study were included in the evidence synthesis. Six medicines were selected as essential for maintenance treatment: lithium, valproate, lamotrigine, olanzapine, quetiapine and clozapine. While risperidone and benzodiazepines were retained for acute mania, carbamazepine and fluoxetine were removed from acute depression. Treatment algorithms for predominantly manic and depressive courses of illness were constructed to encourage person-centred care, aiming for euthymia, individual functioning and relapse prevention. Conclusion. Evidence-based medicine principles enabled the NEMLC to select a range of essential medicines for the management of BD in a middle-income country. Local monitoring and evaluation are needed to inform future editions of the STGs and EML.

Nationwide Etoricoxib Injection Clinical Experience (NICE): Real-World Evidence in Indian Patients.

Introduction Pain is a major health issue globally. Etoricoxib, a highly selective COX-2 inhibitor, given orally, has been found to be efficacious and safe in the management of acute and chronic pain. Oral etoricoxib has been extensively studied; however, there is a lack of research exploring the use of etoricoxib via alternative routes, specifically intramuscular (IM) injection. This study aimed to evaluate the effectiveness and safety of an innovative and novel formulation of IM etoricoxib injection 90 mg/mL in the management of patients with acute pain in India. Method This was a real-world, multicenter, retrospective, observational study to investigate the effectiveness and safety of IM etoricoxib injection in the management of patients with acute pain in India (outpatient setting). The clinical data of 383 patients from 42 centers across India were collected from November 2022 to April 2023. Following approval from the site investigator, comprehensive patient-level information encompassing demographic and clinical variables as well as comorbidities was collected and entered into a case report form. Approval from the Independent Ethics Committee (IEC) and Institutional Review Board (IRB) was sought. The safety and effectiveness at 30 minutes and 60 minutes of IM etoricoxib injection were then analyzed. Results Among the studied patients, etoricoxib was used for the management of knee arthritis, fracture, post-traumatic pain, postoperative cases, acute back pain, back injury, torn ligament, and muscle strain and sprain. Of 383 patients, 98.17% had moderate-to-severe pain at baseline on the visual analogue scale (VAS) (0 being no pain and 10 being severe unbearable pain). The percentage of patients with severe pain reduced to only 6.78% and 4.17% at 30 minutes and 60 minutes, respectively. The improvement in the VAS score was statistically significant from baseline to 30 minutes and 60 minutes, and at 60 minutes compared to 30 minutes (p < 0.0001). More than half the patients (56.91%) had no pain at the site of the injection. Most of the doctors (70.23%) opined that the IM etoricoxib injection was better than their currently used NSAID injections for pain relief. Only 12.79% of patients required rescue analgesia post-IM etoricoxib injection. IM etoricoxib injection was well tolerated as 98.69% of the patients did not experience or report any adverse events post-IM injection. Conclusion This real-world, multicenter, retrospective, observational study across India demonstrated that the innovative and novel formulation of etoricoxib (90 mg/mL IM injection) was effective and well-tolerated in the management of acute pain. Overall, this study provides valuable insights into the real-world effectiveness and safety of IM etoricoxib injections, suggesting it could be a promising therapy for the management of acute pain for optimal patient benefit.

Addressing Perinatal Substance Use: A Triad Approach Led by the Colorado Perinatal Care Quality Collaborative.

Unintentional overdose is a leading driver of maternal death in Colorado. The high volume of maternal deaths from preventable causes lends questions to failures in our clinical and community-based care for pregnant and postpartum people. The Colorado Maternal Mortality Review Committee identified 3 main contributors including stigma in the community and health care system, fragmentation of the health care system, and the need for more clinician training. The Colorado Perinatal Care Quality Collaborative led a 3-pronged intervention to address these challenges and improve perinatal care. The first intervention, the Colorado Alliance for Innovation on Maternal Health Substance Use Disorder quality improvement initiative, partnered with birthing hospitals statewide to institute universal screening and timely referral for individuals at risk of substance use disorder (SUD) and perinatal mood and anxiety disorders. The second intervention, the Improve Perinatal Access, Coordination, and Treatment for Behavioral Health initiative, established a perinatal support network within communities. This program assists individuals with SUD, perinatal mood and anxiety disorders, or social needs to navigate the perinatal period. The third intervention, the Colorado Maternal Overdose Matters Plus program, has enhanced in-hospital access to pharmacotherapy for pregnant and postpartum individuals with SUD through training and technical support. These collaborative initiatives aim to minimize barriers to care by integrating inpatient screening, treatment referrals, pharmacotherapy access, and community care support to mitigate maternal mortality in Colorado.

Improved Diagnostic Confidence Imparted by Radiologists in Radiology Reports After Educational Interventions on Reporting Styles.

Background Radiology reports are important medico-legal documents facilitating communication between radiologists and referring doctors. Language clarity and precision are crucial for effective communication in these reports. Radiology reporting has changed with the evolution of imaging technology, prompting the adoption of precise terminology. Diagnostic certainty phrases (DCPs) play an important role in communicating diagnostic confidence in radiology reports. Objective The aim of this study was to evaluate the use of DCPs in radiology reports, before and after targeted educational interventions. Materials and methods The study was approved by the Aga Khan University Hospital's Ethical Review Committee and includes cross-sectional radiology reports. It involved three cycles of retrospective evaluation, with educational interventions in between to improve the use of DCPs. Results The study found a dynamic shift in the use of DCPs during the three cycles. Initially, intermediate-certainty phrases prevailed, followed by an increase in high-certainty phrases and a drop in low-certainty phrases. Later cycles showed a significant decline in DCPs and an increase in the use of definitive language. Across all subspecialties, there was a consistent decrease in intermediate- and low-certainty DCPs. Conclusion The study validates the transformative impact of educational interventions on the use of DCPs in radiology reports. The radiology reports frequently used DCPs with intermediate to low diagnostic certainty with improvement in the subsequent cycles of the study after educational interventions. It emphasizes the significance of continuing education to ensure the use of precise nomenclature.

FDA Approval Summary: Lisocabtagene Maraleucel for Second-Line Treatment of Large B-Cell Lymphoma.

In June 2022, the FDA extended the indication for lisocabtagene maraleucel (liso-cel) to include adults with large B-cell lymphoma (LBCL) who have refractory disease or relapse within 12 months of first-line chemoimmunotherapy (CIT), as well as transplant-ineligible adults with refractory disease or relapse after first-line CIT. Two clinical trials evaluating a single infusion of liso-cel preceded by lymphodepleting chemotherapy supported the second-line indications. TRANSFORM is a randomized, phase 3, open-label trial comparing liso-cel with standard second-line therapy, including planned autologous hematopoietic stem cell transplantation (HSCT), in 184 transplant-eligible patients. On interim analysis, event-free survival (EFS) by independent review committee (IRC) assessment was statistically significantly improved for the liso-cel arm, with a stratified hazard ratio of 0.34 [95% confidence interval (CI), 0.22-0.51; P < 0.0001]; the estimated median EFS was 10.1 months in the liso-cel arm versus 2.3 months in the control arm. PILOT is a single-arm phase 2 trial of second-line liso-cel in patients who were transplant-ineligible due to age or comorbidities but had adequate organ function for chimeric antigen receptor (CAR) T-cell therapy. Among 61 patients who received liso-cel (median age, 74 years), the IRC-assessed complete response rate was 54% (95% CI, 41-67). Among patients achieving complete response, the estimated 1-year rate of continued response was 68% (95% CI, 45-83). Of the 268 patients combined who received liso-cel as second-line therapy for LBCL, cytokine release syndrome occurred in 45% (Grade 3, 1.3%) and CAR T-cell-associated neurologic toxicities occurred in 27% (Grade 3, 7%), warranting a continued risk evaluation and mitigation strategy.

543 - Early repigmentation of stable vitiligo through point-of-care melanocyte transfer using non-cultured autologous skin cell suspension

Abstract Introduction Vitiligo is an acquired depigmenting skin condition characterized by the loss of skin pigmentation, impacting 0.5% to 2% of the global population.1–3 Vitiligo presents as distinct depigmented patches resulting from autoimmune melanocyte destruction. Individuals with visual vitiligo lesions often experience negative body image, diminished self-confidence, discomfort, and overall lower quality of life (QoL).4 While there are medical treatment options available, these can be associated with poor efficacy and low medication compliance.4 Residual lesions after treatment may require surgical intervention which allows for melanocyte transplantation from an area that is pigmented to one that is lacking functional melanocytes. Through a point-of-care device, a non-cultured autologous skin cell suspension (ACSC) can be prepared using a small skin sample; the ASCS contains healthy melanocytes and is immediately applied onto skin treated with ablative laser to aid in the repigmentation of affected areas. Objective The objective of this study was to evaluate the one-time application of ASCS, with a 1:20 donor to treatment site expansion ratio, for the safe and effective repigmentation of stable vitiligo lesions. Methods A randomized, within-subject controlled, central observer-blinded study was conducted to compare the clinical performance of laser ablation, ASCS, and NB-UVB to NB-UVB alone for repigmentation of stable vitiligo lesions in adults. Subjects received NB-UVB phototherapy on both ASCS-treated and controlled lesions as per recommended by the Vitiligo Working Group. Repigmentation of ASCS-treated and control lesions were categorized by a Central Review Committee (CRC) of blinded dermatologists as one of the following: 0%-25%, 26%-50%, 51%-79%, or 80-100%. The primary effectiveness endpoint was defined as the proportion of lesions achieving ≥80% repigmentation for ASCS-treated versus control areas at Week 24. Early regimentation was assessed at Weeks 4 and 12 as a post hoc analysis. Results A significantly higher proportion of the ASCS-treated areas (36.0%, n = 9) compared to control-treated areas (0.0%) attained ≥80% repigmentation at Week 24 (P = 0.012). At Week 4, 30.4% (n = 7/23) of ASCS-treated areas had ≥26% repigmentation compared to 4.3% (n = 1/23) in the control areas. At Week 12, 56.5% (n = 13/23) of ASCS-treated areas had ≥26% repigmentation compared to 21.7% (n = 5/23) in the control areas. At Week 24, 64% (n = 16/25) of ASCS-treated areas had ≥26% repigmentation compared to 28% (n = 7/25) in the control areas. Conclusion A one-time treatment of ASCS, with the addition of NB-UVB, can result in excellent repigmentation results by 24 weeks, with most subjects seeing ≥26% repigmentation as early as 4 to 12 weeks.

Cross-cultural adaptation and reliability assessment of the Indonesian version of the Computer Workstation Ergonomics: Self-Assessment Checklist.

Prolonged use of computer devices can have adverse health effects, but these can be mitigated by setting up computer workstations according to ergonomic principles. The Computer Workstation Ergonomics: Self-Assessment Checklist can guide workers in implementing these principles. However, the checklist is only available in English, which may reduce the accuracy of the instrument when used by non-English speakers, including Indonesians. The objective of this study was to cross-culturally adapt the Computer Workstation Ergonomics: Self-Assessment Checklist for use in Indonesia. Additionally, a reliability assessment was conducted on the adapted checklist. This study followed a six-stage cross-cultural adaptation process, including translation, synthesis of translation, back translation, expert committee review, pretesting, and documentation submission. The final version of the adapted checklist underwent testing for intra-rater reliability, inter-rater reliability, and internal consistency. The cross-cultural adaptation process resulted in an Indonesian version of the Computer Workstation Ergonomics: Self-Assessment Checklist. Furthermore, the Krippendorff's alpha values for the intra-rater and inter-rater reliability of the adapted checklist ranged from 0.59 to 0.78 (mean = 0.70) and 0.20 to 0.82 (mean = 0.56), respectively. The study produced an Indonesian version of the Computer Workstation Ergonomics: Self-Assessment Checklist that had an adequate reliability. The adapted checklist can serve as a practical tool for evaluating and improving computer workstations in Indonesia.

Preventive analgesia with oral tramadol and pregabalin for post-operative pain in breast surgical patients

Background &amp; objective: Preventive analgesia is implied before the actual surgical insult occurs and it is aimed to reduce the neuro-humoral changes associated with surgical induced pain. Different methods have been used by the anesthesiologists for this purpose. We studied the effect of pre-emptive oral tramadol 50 mg and pregabalin 100 mg on post-operative pain, the requirement of rescue analgesics and the stay in post-anesthesia care unit (PACU) in breast cancer surgery patients. Methodology: A randomized double blinded, placebo-controlled trial, was conducted in the Department of Anesthesia, Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore (Pakistan) after ethical approval by the hospital Scientific Review Committee and Institutional Review Board. Atotal of 30 patients, undergoing breast cancer surgery, were enrolled and randomly divided into two groups. Group A (study group) patients were given tramadol 50 mg and pregabalin 100 mg orally, and Group B (control group) received two soda mint tablets orally 30 min prior to induction of anesthesia. Standard monitoring was done and routine general anesthesia was administered with intubation. After recovery, Visual Analog Scale (VAS) scores and time to rescue analgesia, total morphine consumption, were recorded. Data was analyzed using SPSS v.20. P &lt; 0.05 was considered significant. Results: The mean ages in Group A and B were 36.67 ± 9.50 y and 41.80 ± 12.43 y (P = 0.236). The differences in intra-operative morphine and rescue morphine use in both groups were not significant (P = 0.139 and 0.293, The rescue analgesic use and VAS scores in PACU were significantly different in both groups (P = 0.005 and P = 0.022, respectively). Total PACU stay in Group A was 79.33 ± 26.31 min and in Group B was 96.67 ± 34.98 min (P = 0.281). Tramadol use in the ward was not statistically equivalent (P = 0.300). Mean post-operative rescue morphine was 0.2 ± 0.775 mg/kg in control group as compared to placebo group was 1.4 ± 1.682 mg/kg, which was statistically significant (P = 0.02). VAS scores in PACU in both groups showed statistically differences, e.g., 1.33 ± 1.1 vs 2.70 ± 1.60 (P = 0.01). PACU stay time was also higher in the control group. Conclusion: The use of pre-emptive analgesia with oral tramadol 50 mg and pregabalin 100 mg 30 min before the surgery can reduce the requirement of peri operative opioid use, achieve better pain control and early recovery. Abbreviations: BMI- Basal Metabolic Rate; PACU- Post-Anesthesia Care Unit; PONV- Postoperative Nausea and Vomiting; VAS- Visual Analog Scale Key words: Analgesia, Preventive; Cancer Surgery; Opioids; Post-Anesthesia Care Unit; Pregabalin; Tramadol Citation: Usman A, Mehdi SR, Khan AA. Preventive analgesia with oral tramadol and pregabalin for post-operative pain in breast surgical patients. Anaesth. pain intensive care 2024;28(1):81−84; DOI: 10.35975/apic.v28i1.2374 Received: November 17, 2021; Reviewed: September 24, 2022; Accepted: July 06, 2023