4th Edition Research Articles

A case of neoadjuvant targeted therapy with pralsetinib for locally advanced lung adenocarcinoma with RET fusion mutation

This case report details the successful treatment of a 68-year-old male patient with locally advanced RET-rearranged lung adenocarcinoma using neoadjuvant pralsetinib. The patient initially presented with a suspicious right upper lobe nodule, which was later diagnosed as lung adenocarcinoma following genetic testing that revealed a RET exon 12 fusion. After 2 months of neoadjuvant treatment with pralsetinib, a significant radiological response was observed, with a reduction in tumor size and metabolic activity. Subsequently, the patient underwent video-assisted thoracoscopic right upper lobectomy and mediastinal lymph node dissection. Postoperative pathological analysis revealed a major pathological response, with only 5% residual tumor cells in the primary lesion and no viable tumor cells in the lymph nodes. Postoperative pathological staging of TNM was ypT1aN0M0, stage IA1(AJCC, 8th edition). The patient recovered well after surgery, demonstrating the potential efficacy of neoadjuvant pralsetinib in locally advanced RET-rearranged lung adenocarcinoma. However, further clinical validation is required to establish the role of neoadjuvant targeted therapy and postoperative adjuvant therapy in this patient population.

The efficacy of loco-regional ropivacaine analgesia via intercostal catheters after lung resection: a randomized, double-blind, placebo-controlled, superiority study.

Postoperative pain remains a burden for patients after minimally invasive anatomic lung resection. Current guidelines recommend the intraoperative placement of intercostal catheters to promote faster recovery. This trial aimed to determine the analgesic efficacy of continuous loco-regional ropivacaine application via intercostal catheter and establish this method as a possible standard of care. Between December 2021 and October 2023, patients were randomly assigned to receive ropivacaine 0.2% or a placebo through an intercostal catheter with a flow rate of 6-8 ml/h for 72 h after surgery. Patients were undergoing anatomic VATS lung resection under general anaesthesia for confirmed or suspected stage I lung cancer (UICC, 8th edition). The sample size was calculated to assess a difference in numerical rating scale associated with pain reduction of 1.5 points. Fourteen patients were included in the ropivacaine group, whereas the placebo group comprised 18 participants. Patient characteristics and preoperative pain scores were similar in both groups. There was no statistically significant difference in postoperative pain scores and morphine consumption between the 2 groups. The mean numerical rating scale when coughing during the first 24 h postoperatively was 4.9 (SD: 2.2) in the ropivacaine group and 4.3 (SD: 2.4); P = 0.47 in the placebo group. We were unable to determine any effect of administered ropivacaine on the postoperative pulmonary function (FEV1, PEF). Our preliminary results suggest that continuous loco-regional ropivacaine administration via surgically placed intercostal catheter has no positive effect on postoperative pain scores or morphine requirements. NCT04939545.

Solar elastosis correlates with high tumor mutation burden and better 5-year disease-specific survival in patients with stage II/III melanoma

ObjectiveTo evaluate the relation between solar elastosis and tumor mutation burden (TMB) in a large clinically annotated cohort of stage II and III melanoma patients. MethodsPrimary cutaneous melanomas from 469 AJCC (8th edition) stage II and III patients with clinical annotation including outcome at 5 years of diagnosis were histopathologically evaluated for solar elastosis. Next-generation sequencing assay MSK-IMPACTTM was employed to determine TMB. Analysis by Fisher’s exact test, chi-square, and Kruskal-Wallis were performed, as well as uni- and multivariate logistic regression. ResultsTumors stratified by low and high TMB showed marked and statistically significant differences in presence and extent of associated solar elastosis. Lower risk patient stage (II versus III by AJCC 8th edition) as well as better 5-year melanomaspecific survival (as binary variable of controls-survivors versus cases-dead of disease at 5 years of diagnosis) were associated with severe solar elastosis. On univariate and multivariate logistic regression models, severe solar elastosis predicted significantly decreased odds of dying of melanoma within 5 years of diagnosis (OR 0.60, 95% CI 0.39-0.89; and OR 0.42, 95% CI 0.20-0.83, respectively; both p<0.05) ConclusionThe association of solar elastosis to TMB and 5-year melanoma specific survival points to its potential as a biomarker of clinical relevance that can be assessed by routine histopathology.

Vitamin D Levels and Temporomandibular Disorders: A Bidirectional Two-Sample Mendelian Randomization Analysis.

Growing researches explore vitamin D's role in temporomandibular disorders (TMDs), but the link between vitamin D and TMDs remains debated. To clarify the causal relationship, we conducted a Mendelian randomization (MR) analysis using data from genome-wide association studies (GWAS). The GWAS dataset of vitamin D (GWAS ID: ukb-d-30890_irnt; sample size: 329247) was obtained from the IEU Open GWAS project. And that of TMDs (GWAS ID: finn-b-TEMPORO; sample size: 134280), initiated on August 25th, 2017 and publicly released on December 18th, 2023, was extracted from the FinnGen dataset, whose cases were diagnosed based on the revised International Classification of Diseases, 10th Edition (ICD-10) code K07.6. Both datasets were obtained from the European population. According to three assumptions of MR analysis, a bi-directional MR analysis was performed to measure the causal relationship, with Inverse variance weighted (IVW) as the primary method and MR Egger and Weighted median as supplement. Moreover, diverse sensitivity analyses, including Cochran's Q test, MR Egger intercept, Mendelian randomized polymorphism RESidual Sum and Outlier (MR-PRESSO), and leave-one-out analysis, were used to verify the stability of the findings. The MR analysis supported causal effects of vitamin D levels on TMDs risks within the European population using IVW method [odds ratio = 1.316; 95% confidence interval = 1.086 to 1.595; P = 0.005], supported by MR Egger and Weighted median. While there was no indication that TMDs have a direct impact on vitamin D levels [β: -0.00738, standard error = 0.00665; P = 0.568]. The study revealed that within the European population higher levels of vitamin D led to higher risks of developing temporomandibular disorders, but found no obvious evidence that TMDs are causally associated with vitamin D. The conclusion should be cautiously interpreted, given the selection bias of TMDs patients sample.

Validation of clinical tumor depth of invasion measure in patients with oral cavity cancer

ObjectivesThe 8th edition of the American Joint Committee on Cancer (AJCC) for head and neck malignancies incorporated depth of invasion (DOI) for oral cavity squamous cell carcinoma (OCSCC). Currently, there is no standardized method to determine clinical DOI (cDOI). We aim to validate radiologic DOI (rDOI) utilizing contrast-enhanced computed tomography (CECT) imaging. Materials and MethodsRadiographic DOI was defined as the coronal measurement of the deepest margin parallel to the expected normal mucosal plane. To establish a valid, accurate and repeatable rDOI, a retrospective cohort at a single institution tertiary hospital underwent preoperative CECT. Radiographic DOI was independently assessed by 2 neuroradiologists. Correlation was determined between rDOI and pDOI. A prospective pilot study of 49 patients with newly diagnosed OCSCC underwent rDOI assessment compared to final pDOI to assess our rDOI method clinical applicability. ResultsNeuroradiologists demonstrated a high degree of predictability between rDOI and pDOI with as great as 90.91% accuracy for readable CECTs. Inter-observer correlations were strong in the retrospective (Session 1: ICC= 0.956; Session 2: ICC= 0.932) and prospective cohorts (Session 1: ICC= 0.859; Session 2: ICC=0.913) illustrating reliability. Intraobserver correlations were also strong (Retrospective Reader 1 ICC=0.968, Reader 2 ICC=0.941; prospective Reader 1 ICC=0.965, Reader 2 ICC=0.800, p<0.001). T1 lesions were immeasurable 25-62.5% of the time. ConclusionsUsing CECT, the coronal measurement of the deepest margin parallel to the expected normal mucosal plane can enhance determination of a reliable cDOI in OCSCC corresponding to pDOI without change in staging for T2 and greater lesions.

Role of Surgery in Potentially Resectable Small-Cell Lung Cancer Based on the Eighth Edition of the TNM Classification: A Population Study of the US SEER Database.

This study aimed to identify a specific SCLC population that would benefit from surgery. This study utilized patient data retrieved from the Surveillance, Epidemiology, and End Results (SEER) database spanning 2010 to 2017. To mitigate clinical biases, the propensity score matching (PSM) technique was employed. Separate cohorts were aligned using PSM according to the AJCC 8th edition TNM classification. The Kaplan-Meier method and a competing risk model were applied to evaluate overall survival (OS) and lung cancer-specific survival (LCSS), respectively. Among the 3394 patients with potentially resectable SCLC included in the study, 3062 underwent chemoradiotherapy and 332 underwent surgical treatment with adjuvant chemotherapy. Surgery was associated with better OS (median OS: 49 months; 95% CI: 35-63 months vs. 27 months; 95% CI: 21-33 months, p < 0.001) and LCSS (SHR, 0.578; 95% CI: 0.411-0.815, p < 0.001) in stage I patients after PSM. However, there was no significant difference in OS and LCSS between the surgery and nonsurgery groups in stage II and III patients after PSM. In the entire cohort, lobectomy was associated with improved OS (median OS: 48.6 vs. 28.7 months, p < 0.0001), but not LCSS (SHR, 0.696; 95% CI: 0.466-1.040, p = 0.078) compared with sublobar resection after PSM. Surgery with adjuvant chemotherapy significantly improved the survival prognosis of patients with early-stage SCLC. However, surgical treatment should be carefully considered in patients with stage II/III disease. Lobectomy is oncologically equal to sublobar resection.

Nouveautés en pathologie thyroïdienne : classification OMS 2022, système Bethesda 2023, biologie moléculaire et testing moléculaire

WHO CLASSIFICATION 2022, BETHESDA SYSTEM 2023, MOLECULAR BIOLOGY AND MOLECULAR TESTING: Thyroid pathology has experienced significant advances with the publication of the 5th edition of the World Health Organization classification of endocrine tumors in 2022 and the third edition of the Bethesda system for thyroid cytopathology in 2023. At the same time, the availability of next-generation sequencing data coupled with numerous translational research projects have considerably increased our knowledge of the genomics and mechanics of thyroid cancers, enabling us to refine prognosis and propose new targeted therapies. In this review, we will take up the main new features of the WHO 2022 and Bethesda 2023 classifications, as well as molecular biology findings, with an emphasis on the practical implications for clinicians.

Effect of calcium channel blockers on influenza incidence: a population-based retrospective cohort study using administrative claims data in Japan

ObjectivesLaboratory experiments have indicated that calcium channel blockers (CCBs) inhibit the entry and replication of influenza A virus in cells. However, no clinical studies have assessed the incidence of influenza...

Diagnostic classification systems in psychiatry

For the last 30 years the 10th edition of the International Classification of Diseases (ICD-10) has aided clinicians in the UK in diagnosing mental disorders. Classification systems are important in ensuring a consistent approach to accurate diagnoses and a common language for communicating them. Such an approach to classification has further advantages in terms of influencing clinical decision making, research, and public policy. In 2022, the ICD-11 was published, including changes to the classification systems and diagnostic requirements for some disorders. Although the ICD has codes for many diseases, we aim to explain the changes in diagnostic criteria for psychiatric disorders in the new ICD-11 in a concise and primary care focused way.

Prescription patterns and symptom relief of antitussives and expectorants in patients with cough: a nationwide study in Korea.

Limited data are available on the prescription patterns and efficacy of antitussives and expectorants for patients with acute and chronic cough. This study examined the use and efficacy of these medications in a nationally representative sample of Korean patients. We examined 4,206,016 individuals from the National Health Insurance Service (NHIS)-National Health Information Database (NHID) between 2015 and 2017. Among them, a sample of 10% (n=420,602) was retrieved for the diagnosis of respiratory diseases using the International Classification of Diseases, 10th edition (ICD-10; J00-J99), or the prescription of antitussives and expectorants for cough (ICD-10; R05). The acute cough group included those who were prescribed medications within 4 weeks of initial diagnosis (prescription within 14 days), whereas the chronic cough group included patients who were prescribed medications within 16 weeks of initial diagnosis (prescription within 56 days). If the prescription was discontinued or not changed to an alternative drug after the initial prescription, these cases were considered to have achieved symptom relief. This study included 288,460 patients (971,065 cases) with acute cough and 5,888 patients (15,399 cases) with chronic cough. 'Expectorants, excluding combinations with cough suppressants' had the highest prescription rates in both groups (acute cough, 63.8%; chronic cough, 61.7%), and showed the highest symptom relief regardless of the number of medications prescribed (acute cough, 84.3%; chronic cough, 70.4%). 'Expectorants, excluding combinations with cough suppressants' were the most prescribed and effective medications for relieving cough symptoms in Korea patients. Further studies are needed to determine the optimal duration for using antitussives and expectorants in cough management.

Impact of location and size of minimal extrathyroidal extension on lymph node metastasis in papillary thyroid cancer: a retrospective analysis.

The 8th edition of the American Joint Committee on Cancer (AJCC)'s T-stage for differentiated thyroid cancer (DTC) removes minimal extrathyroidal extension (mETE), while ignoring the risk of mETE would lead to overtreatment or inadequate treatment. The aim of this study was to investigate the impact of location and size of mETE on lymph node metastasis in papillary thyroid cancer (PTC). A retrospective analysis of 267 patients who underwent unilateral radical surgery for PTC was conducted. According to the postoperative pathology, they were divided into mETE group (121 patients) and non-mETE group (146 patients). The number of lymph nodes dissected and the number of lymph nodes metastasized were compared between the two groups. The linear regression analysis and the receiver operating characteristic (ROC) curves were performed to evaluate the impact of the locations and sizes on lymph node metastasis. There was no significant difference in the number of lymph node dissected between the mETE group and the non-mETE group. The tumor located at the upper part and the size <1.0 cm in mETE group showed a higher number of lymph node metastasis (0.78±0.88 vs. 0.25±0.45, P=0.03). Meanwhile, in the mETE group, the number of patients with lymph node metastasis was higher than that in the non-mETE group. Further subgroup analysis revealed that for PTC patients with tumors at the upper part and size <1.0 cm, the number of those with lymph node metastasis in the mETE group was also greater than that in the non-mETE group. Furthermore, the Spearman correlation analysis showed a positive correlation between tumors located at the upper part with a size <1.0 cm and lymph node metastasis rate (R=0.647, P=0.004). Additionally, if the upper part tumor was within 1 cm, the tumor's size was able to identify the lymph node metastasis, with the optimal cut-off point of 0.45 cm (Youden index =0.650). When tumors combine with mETE, the probability of lymph node metastasis increases in tumors located at the upper part with a size <1.0 cm. Especially, when the upper part tumor is within 1 cm, the tumors of size ≥0.45 cm are more likely to have lymph node metastasis.

Kain i Abel to my

CAIN AND ABEL ARE US. INCLUSIVITY IN INTERMEDIAL TRANSLATIONInclusivity in the context of translation is most commonly associated with inclusive language, not excluding anyone regardless of age, gender, orientation, disability, or origin. However, this concept can also be interpreted as involving the audience to co-participate in creating meaning, especially – though not exclusively – in the context of art. This article is dedicated to inclusivity understood in this way in intermedial translation. Its goal is to reveal the mechanisms of translating the title of the 7th edition of the theatrical meetings ‘Bliscy Nieznajomi’ (Close Strangers) which was ‘Cain and Abel’ onto various visual objects: poster, festival newspaper, and 3D installation.

Is it up to language? Pragmatic competence in Croatian preschool children with autism and typical development

Objectives The relationship between structural language ability and pragmatics is not fully understood, in either individuals with autism or those with typical development (TD). Despite the well-established understanding that core deficits in autism lie in pragmatics, specific pragmatic behaviours that distinguish autistic children (AC) from their TD peers are not sufficiently described. The aims of this study were as follows: to investigate the differences in language abilities and pragmatic competence between AC and those with TD; to examine the relationship between language comprehension/production and pragmatic competence in both groups; and to identify the items of pragmatic composite that are most discriminative in detecting AC. Methods The participants in this study were preschool-aged children with TD (N = 45; mean age 65.5 months) and AC with average nonverbal IQ scores (N = 32; mean age 72.9 months). Language production and comprehension abilities were assessed using the New Reynell Developmental Language Scales (4th edition), and pragmatic competence was measured using the Children’s Communication Checklist (CCC). Results For all language and pragmatic variables, AC performed worse than those with TD. Pragmatic competencies did not correlate with structural language skills in either group, except for a correlation between language production and coherence in the TD. Finally, certain pragmatic behaviours common to many AC and rarely found in children with TD were identified as potential distinguishing features between the two groups. Conclusions This study underscores the importance of incorporating pragmatic assessments alongside traditional language evaluations and suggests that interventions should target pragmatic competence specifically, especially in preschool AC.

A Population-Level Validation of the New 9th Edition of the American Joint Commission on Cancer Staging System for Anal Squamous Cell Carcinoma.

The staging system for anal squamous cell carcinoma (ASCC) was recently revised, downstaging selected node-positive patients and upstaging some with larger tumors. We aimed to validate this staging system using a population-based cohort. The Surveillance, Epidemiology, and End Results database was analyzed to identify adult ASCC patients. Patients were staged according to the American Joint Committee on Cancer (AJCC) 8th and 9th edition systems. Survival probabilities were estimated using Kaplan-Meier curves. Cox regression models were utilized to estimate the effect of stage on overall (OS) and cancer-specific survival (CSS). A total of 2117 patients were identified and staged based on the two AJCC classifications. At 24 months when comparing stage IIB versus stage IIIA, the 8th edition revealed an improved OS (79% vs. 88%) and CSS (84% vs. 91%) for stage IIIA disease, while the 9th edition restored the hierarchical OS (IIB 88% vs. IIIA 78%) and CSS (91% vs. 82%) order. The hierarchical increase of the OS HRs, and nearly all CSS HRs, across disease stages validated the updated edition of the AJCC classification. Although this change may not have significant implication on the management of ASCC, it does provide better prognostication.

Revisiting the survival paradox between stage IIB/C and IIIA colon cancer.

Patients with stage IIB/C (T4a-bN0) colon cancer often exhibit worse survival rates compared to those with stage IIIA (T1-2N1, T1N2a) colon cancer. This study re-evaluates the survival paradox using the latest Surveillance, Epidemiology, and End Results (SEER) data (released on April 17, 2024) to inform potential revisions to the staging criteria. Utilizing SEER data with 8th edition TNM staging criteria, 4692 colon cancer patients diagnosed between 2018 and 2021 were analyzed with chi-square test. Cox regression and Kaplan-Meier survival analysis were employed to assess factors associated with cancer-specific survival (CSS) and overall survival (OS). The 3-year CSS rates for stage IIB and IIC were 73.1% and 70.3%, respectively, whereas stage IIIA had a substantially higher CSS rate of 91% (P < 0.001). Similarly, the OS rates were 64.9% and 63.0% for stage IIB and IIC, respectively, compared to 83.1% for stage IIIA (P < 0.001). Multivariate analyses revealed stage IIIA patients had significantly lower risks of cancer-specific mortality (hazard ratio (HR) = 0.374, 95% CI: 0.296-0.473, P < 0.001) and overall mortality (HR = 0.575, 95% CI: 0.483-0.685, P < 0.001) compared to stage IIB patients. The upcoming 9th edition of the AJCC staging system should address this paradox by integrating advanced diagnostic markers and emphasizing the aggressive biology of T4 tumor, providing more accurate prognostic information and guiding more effective treatment strategies for colon cancer patients.

An extremely rare case of thymic squamous cell carcinoma complicated with B3 thymoma and myasthenia gravis: a case report

BackgroundThymomas complicated with myasthenia gravis are conventionally treated during thoracic surgery. Particularly, invasive thymomas are resected alongside the surrounding organs. Here, we present a case where surgical and perioperative management was performed under the presumption of thymoma with myasthenia gravis. However, definitive pathology revealed the co-occurrence of B3 thymoma and thymic squamous cell carcinoma. This case highlights the unique presentation and exceptional rarity of thymomas that are complicated by myasthenia gravis and thymic carcinoma. Case presentationA 65-year-old female presented with eyelid ptosis at our hospital. Following a comprehensive examination, the patient was diagnosed with myasthenia gravis. Her computed tomography (CT) scan revealed an anterior mediastinal tumor suggestive of a thymoma, prompting a referral to the Department of Thoracic Surgery. Moreover, preoperative assessment could not definitively exclude pericardial invasion. She subsequently underwent an extended thymectomy via a longitudinal sternal incision. The tumor exhibited partial invasion of the pericardium, necessitating resection and reconstruction. Definitive pathological examination confirmed the co-occurrence of B3 thymoma and thymic squamous cell carcinoma. Positive lymph node metastasis classified the patient as stage IVa according to the Union for International Cancer Control (UICC) TNM Classification of Malignant Tumors, 8th Edition, and she was started on adjuvant radiotherapy postoperatively. Currently, the patient remains under observation, with follow-up CT scans showing no signs of recurrence.ConclusionsThis report describes an extremely rare case of thymoma complicated with myasthenia gravis and thymic squamous cell carcinoma.

Subtotal versus total gastrectomy for distal diffuse-type gastric cancer.

Diffuse-type gastric carcinoma in an aggressive form of gastric cancer. Surgery is the only potentially curative treatment. It is controversial whether patients with diffuse-type gastric carcinoma should undergo total or subtotal gastrectomy when feasible. The aim of this study is to analyze the oncologic outcomes and overall survival of patients diagnosed with distal diffuse-type gastric cancer undergoing subtotal versus total gastrectomy with curative intent. This retrospective study included all patients with histologically confirmed diffuse-type distal gastric carcinoma and clinical staging cT1-4M0, who underwent surgery with curative intent between 2011 and 2020 in a Tertiary Referral Hospital in Chile. Clinical and pathological staging was conducted using the 8th Edition of the American Joint Committee on Cancer Classification. STG group was comprised by patients who underwent subtotal gastrectomy and TG group by patients who underwent total gastrectomy. Both groups were compared in relation to sociodemographic variables, pathology reports and perioperative data which were obtained from electronic medical records. Data analysis was obtained with Stata 16.1 Statistical Software. One hundred and thirty patients underwent curative intent surgery. Subtotal gastrectomy with D2-lymphadenectomy was completed in 68 patients (52%). An R0 resection was achieved in all patients. Median number of resected lymph nodes, tumor size, proximal margin and depth of invasion were similar in both groups. Pathologicstaging was similar between both groups, the most frequent being Stage 3(54%). After a median follow-up of 47 months [0.3-157], no difference was observed in overall survival between both groups (5-year-OS 63% in STG group versus 51% in TG group, p = 0.097). Oncologic and survival outcomes were similar in patients submitted to subtotal and total gastrectomy,suggesting that a subtotal gastrectomy with D2-lymphadenectomy for distal diffuse-type gastric carcinoma is not associated with a decrease in median overall survival and is an adequate surgical approach when technically feasible.

Role and Outcomes of Supported Community Living Programs in Post-Hospital Brain Injury Rehabilitation Programs.

(1) To determine the proportion of participants admitted to supported community living (SCL) programs over the course of 5 years who improve, decline, or maintain functioning and community integration and (2) to examine the associations of time since injury, time in program, and age to their functional trajectory. Data from SCL programs serving individuals with acquired brain injury (ABI). 104 individuals with traumatic brain injury (TBI), stroke, or other ABI. Sex, age, time since injury, Mayo-Portland Adaptability Inventory (4th edition; MPAI-4). Retrospective analyses of MPAI-4 total and MPAI-4 indices using Linear Mixed Models (LMM) of Rasch-derived T-scores from admission to 5 years into service delivery. MPAI-4total, index, and subscale scores for yearly intervals of SCL services from admission to 5years showed a high degree of stability in function (defined using the standard error of measurement (SEM) for the MPAI-4, defined as change≥3T-score points) with all intervals showing at least 89% of patients with improved scores or no change. The rate of change over time did not significantly vary by time since injury, time in the program, or age. The expectations for services in the SCL portion of the care continuum for ABI are unique. Unlike intensive rehabilitation programs which focus on improvement often earlier in the course of recovery, the goal of SCL services is sustained functioning over the long term. Analyses reported here indicate this can be achieved for at least 5years, potentially mitigating the increased risk for rehospitalization and increased care needs in the ABI population. This study highlights a key finding of MPAI-4 stability within these understudied brain injury service lines. Additional exploration of comorbidities and more nuanced delineation of diagnostic information could further clarify factors influencing outcome stability over time.

Are paediatric cardiology textbooks obsolete in the current digital era?

With the rise of online references, podcasts, webinars, self-test tools, and social media, it is worthwhile to understand whether textbooks continue to provide value in medical education, and to assess the capacity they serve during fellowship training. A prospective mixed-methods study based on surveys that were disseminated to seven paediatric cardiology fellowship programmes around the world. Participants were asked to read an assigned chapter of Anderson's Pediatric Cardiology 4th Edition textbook, followed by the completion of the survey. Open-ended questions included theming and grouping responses as appropriate. The survey was completed by 36 participants. When asked about the content, organisation, and utility of the chapter, responses were generally positive, at greater than 89%. The chapters, overall, were rated relatively easy to read, scoring at 6.91, with standard deviations plus or minus 1.72, on a scale from 1 to 10, with higher values meaning better results. When asked to rank their preferences in where they obtain educational content, textbooks were ranked the second highest, with in-person teaching ranking first. Several themes were identified including the limitations of the use of textbook use, their value, and ways to enhance learning from their reading. There was also a near-unanimous desire for more time to self-learn and read during fellowship. Textbooks are still highly valued by trainees. Many opportunities exist, nonetheless, to improve how they can be organised to deliver information optimally. Future efforts should look towards making them more accessible, and to include more resources for asynchronous learning.

Quality assessment of common anti-malarial medicines marketed in Gambella, National Regional State, South Western-Ethiopia

BackgroundOver the past years, there has been a growing concern that a considerable amount of anti-malarial supply in the underdeveloped world particularly in the private sector, is of poor quality. The World Health Organization (WHO) has received about 1500 reports that mentions instances of substandard and falsified products since 2013. The majority of the reports concerned antibiotics and anti-malarials. The majority of reports (42%) originate from the WHO African region.ObjectiveThis study intends to assess the quality of the most widely used anti-malarial medications [artemether-lumefantrine tablets, chloroquine phosphate tablets, primaquine phosphate tablets, artesunate, and artemether injections] in Gambella, South-West, Ethiopia.MethodsA total of 52 samples were collected on June 2022 from Gambella National Regional State, Ethiopia. Half of the districts (six) located in the four zones of the region were chosen using simple random sampling technique. All drug retail outlets available in the selected districts (locally known as woredas) were included. The samples were subjected to visual inspection with a tool adopted from the joint WHO/FIP/ USP checklist. The pharmacopeial tests for identification, uniformity of dosage forms, assay, thickness, diameter, hardness, friability, disintegration test, dissolution, and sterility tests were carried out according to the USP 44-NF 39 and International Pharmacopoeia 11th edition, 2022 monographs.Results and DiscussionOnly 25% of the samples were registered on the Ethiopian Food and Drug Authority (EFDA’s) electronic regulatory/ registration system (ERIS). Besides, 88.8% of artemether injection products were presented in clear glass ampoules. This might expose the products to photochemical degradation that leads to in loss of anti-plasmodial activity. In addition, 50% of the artemether products assessed were not bioequivalent with the comparator product in the in vitro dissolution comparison tests. Overall, the study findings reveal a high prevalence (58.3%) of substandard anti-malarial drugs in the region. The stated percent of the samples had failed in one or more of the quality test parameters assessed in this study.ConclusionThe study findings reveal a high prevalence (58.3%) of substandard anti-malarial drugs in the region. Only a quarter were registered and 38% of the unregistered products failed the quality tests. Hence, the national, regional medicine regulatory bodies and other stake holders should perform the required roles to circumvent presence of Substandard and Falsified (SF) anti-malarial drugs in the study sites.