Effect of remedial teaching on academic performance of poorly performing students in pharmacology: a Quasi experimental study

Background: Significant learning difficulties requiring remediation has been observed to be experienced by many medical trainees. Research with regard to individualized remedial teaching based on pedagogical diagnosis is a strong need of the time. The objectives of this study were to assess the effect of remedial teaching in improving academic performance among poorly performing students in pharmacology and to assess factors that could affect academic performance.Methods: The study was conducted in 2019. Academically poor performing students (<50 % marks in pharmacology first sessional exam) were selected after getting informed consent. After obtaining baseline information and study skills self-assessment inventory information from all students, academically poor performing students (53 students) were identified and they were randomized into two groups. One group (26 students) received academic support alone. The second group (27 students) received academic support, sessions on study skills, stress-coping strategies and counselling regarding their academic and non-academic problems.Results: The improvement in test scores among all participants of remedial sessions was statistically significant. Mean pre-test mark was 5.27±3.6, post-test was 14.63±1.24 and the difference is statistically significant. Though apparently high 10.02±3.25 versus 8.59±3.55, the post intervention gain in scores is not statistically significant between academic support+special package group versus academic support alone group (p value 0.16).Conclusions: Tailored or individualized remediation measures can greatly enhance the academic performance of undergraduate medical students and help them make satisfactory progress on the course

recommendations by the Conect4Children expert advice group

Funding Information: Competing interests: A.V.R. has received Speaker fees/Consultant for Abbvie, Novartis, UCB, SOBI, Eli Lilly and Roche. N.M. reports grants outside the submitted work in the last five years from the Medical Research Council, National Institute of Health Research, March of Dimes, British Heart Foundation, HCA international, Health Data Research UK, Shire Pharmaceuticals, Chiesi Pharmaceuticals, Prolacta Life Sciences, and Westminster Children’s Research Fund; N.M. is a member of the Nestle Scientific Advisory Board and accepts no personal remuneration for this role. N.M. reports travel and accommodation reimbursements from Chiesi, Nestle and Shire. N.M. is a member of C4C, International Neonatal Collaboration (INC), UK National Research Ethics Advisory Service and MHRA advisory groups and/or working parties. S.W. has received compensation as a member of the scientific advisory board of AM Pharma, Novartis and Khondrion and receives research funding from IMI2 for the Conect4children project. B.A. has worked for GlaxoSmithKline between October 2006 and September 2009 and holds company shares. Between October 2009 and May 2015, she has worked for Novartis. M.S. has recieved research grant and honoraria for meetings and Advisory Boards from Alexion, Sanofi/Genzyme, Takeda, CHIESI, Ultragenix, Orchard, Orphazyme. P.I. is a permanent employee of Bayer AG, Germany. M.V. has received compensation for Advisory boards or Steering committes from Roche, Novartis, Achillion, Apellis, Retrophin/Travere, Alexion pharmaceuticals. C.M. has been a consultant to or has received honoraria from Janssen, Angelini, Servier, Nuvelution, Otsuka, Lundbeck, Pfizer, Neuraxpharm and Esteve outside the submitted work. She declares conflicts of interest unrelated to the present work. M.C. had advisory roles for AstraZeneca, Bayer, Bristol Myers Squibb, Eisai, Lilly, and Roche in the last 2 years (outside the topic of the submitted work, for oncology drugs). M.J. has received research grants from Shire and has been engaged as a speaker or consultant by Shire, Ginsana, PCM Scientific Evolan, and New Nordic, all unrelated to the present work. P.S. has received speaker fees and participated at advisory boards for Biomarin, Zogenyx, GW Pharmaceuticals, and has received research funding by ENECTA BV, GW Pharmaceuticals, Kolfarma srl., Eisai. E.R. has received speaker fees and participated at advisory boards for Eisai and has received research funding by GW Pharmaceuticals, Pfizer, Italian Ministry of Health (MoH) and the Italian Medicine Agency (AIFA). This work was developed within the framework of the DINOGMI Department of Excellence of MIUR 2018-2022 (legge 232 del 2016). M.A.R. is a member of the c4c Ethics Expert Group and received compensation for ethical consulting activities from Bayer AG Wallace Crandall is employee of Eli Lilly and Co. P.C. is an employee of UCB, and owns stock in the company. She was previously an employee of GSK and owns stock in the company. N.R. has received honoraria for consultancies or speaker bureaus from the following pharmaceutical companies in the past 3 years: Ablynx, Amgen, Astrazeneca-Medimmune, Aurinia, Bayer, Bristol Myers and Squibb, Cambridge Healthcare Research (CHR), Celgene, Domain therapeutic, Eli-Lilly, EMD Serono, Glaxo Smith and Kline, Idorsia, Janssen, Novartis, Pfizer, Sobi, UCB. The IRCCS Istituto Giannina Gaslini (IGG), where NR works as full-time public employee has received contributions from the following industries in the last 3 years: Bristol Myers and Squibb, Eli-Lilly, F Hoffmann-La Roche, Novartis, Pfizer, Sobi. This funding has been reinvested for the research activities of the hospital in a fully independent manner, without any commitment with third parties. M.L. receives/has received consultation fees from CSL Behring, Novartis, Roche and Octopharma, travel grants from Merck Serono, and been awarded educational grants to organise meetings by Novartis, Biogen Idec, Merck Serono and Bayer. All other authors have no disclosures. Funding Information: Conect4children has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777389. The Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. The views expressed in this article are the personal views of the author(s) and should not be interpreted as made on behalf of, or reflecting the position of, the regulatory agency/agencies or organisations with which the author(s) is/are employed/affiliated . Publisher Copyright: © 2021, The Author(s).Background: The COVID-19 pandemic has had a devastating impact on multiple aspects of healthcare, but has also triggered new ways of working, stimulated novel approaches in clinical research and reinforced the value of previous innovations. Conect4children (c4c, www.conect4children.org) is a large collaborative European network to facilitate the development of new medicines for paediatric populations, and is made up of 35 academic and 10 industry partners from 20 European countries, more than 50 third parties, and around 500 affiliated partners. Methods: We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equity. Findings: We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equityWe provide examples of research innovation, and follow this with recommendations to improve the efficiency of future trials, drawing on industry perspectives, regulatory considerations, infrastructure requirements and parent–patient–public involvement. We end with a comment on progress made towards greater international harmonisation of paediatric research and how lessons learned from COVID-19 studies might assist in further improvements in this important area.publishersversionepub_ahead_of_prin

Mortality from gastrointestinal congenital anomalies at 264 hospitals in 74 low-income, middle-income, and high-income countries: a multicentre, international, prospective cohort study

Summary Background Congenital anomalies are the fifth leading cause of mortality in children younger than 5 years globally. Many gastrointestinal congenital anomalies are fatal without timely access to neonatal surgical care, but few studies have been done on these conditions in low-income and middle-income countries (LMICs). We compared outcomes of the seven most common gastrointestinal congenital anomalies in low-income, middle-income, and high-income countries globally, and identified factors associated with mortality. Methods We did a multicentre, international prospective cohort study of patients younger than 16 years, presenting to hospital for the first time with oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation, and Hirschsprung’s disease. Recruitment was of consecutive patients for a minimum of 1 month between October, 2018, and April, 2019. We collected data on patient demographics, clinical status, interventions, and outcomes using the REDCap platform. Patients were followed up for 30 days after primary intervention, or 30 days after admission if they did not receive an intervention. The primary outcome was all-cause, in-hospital mortality for all conditions combined and each condition individually, stratified by country income status. We did a complete case analysis. Findings We included 3849 patients with 3975 study conditions (560 with oesophageal atresia, 448 with congenital diaphragmatic hernia, 681 with intestinal atresia, 453 with gastroschisis, 325 with exomphalos, 991 with anorectal malformation, and 517 with Hirschsprung’s disease) from 264 hospitals (89 in high-income countries, 166 in middleincome countries, and nine in low-income countries) in 74 countries. Of the 3849 patients, 2231 (58·0%) were male. Median gestational age at birth was 38 weeks (IQR 36–39) and median bodyweight at presentation was 2·8 kg (2·3–3·3). Mortality among all patients was 37 (39·8%) of 93 in low-income countries, 583 (20·4%) of 2860 in middle-income countries, and 50 (5·6%) of 896 in high-income countries (p<0·0001 between all country income groups). Gastroschisis had the greatest difference in mortality between country income strata (nine [90·0%] of ten in lowincome countries, 97 [31·9%] of 304 in middle-income countries, and two [1·4%] of 139 in high-income countries; p≤0·0001 between all country income groups). Factors significantly associated with higher mortality for all patients combined included country income status (low-income vs high-income countries, risk ratio 2·78 [95% CI 1·88–4·11], p<0·0001; middle-income vs high-income countries, 2·11 [1·59–2·79], p<0·0001), sepsis at presentation (1·20 [1·04–1·40], p=0·016), higher American Society of Anesthesiologists (ASA) score at primary intervention (ASA 4–5 vs ASA 1–2, 1·82 [1·40–2·35], p<0·0001; ASA 3 vs ASA 1–2, 1·58, [1·30–1·92], p<0·0001]), surgical safety checklist not used (1·39 [1·02–1·90], p=0·035), and ventilation or parenteral nutrition unavailable when needed (ventilation 1·96, [1·41–2·71], p=0·0001; parenteral nutrition 1·35, [1·05–1·74], p=0·018). Administration of parenteral nutrition (0·61, [0·47–0·79], p=0·0002) and use of a peripherally inserted central catheter (0·65 [0·50–0·86], p=0·0024) or percutaneous central line (0·69 [0·48–1·00], p=0·049) were associated with lower mortality. Interpretation Unacceptable differences in mortality exist for gastrointestinal congenital anomalies between lowincome, middle-income, and high-income countries. Improving access to quality neonatal surgical care in LMICs will be vital to achieve Sustainable Development Goal 3.2 of ending preventable deaths in neonates and children younger than 5 years by 2030

Effect of remedial teaching on academic performance of poorly performing students in Pharmacology

AbstractPurposeSignificant learning difficulties requiring remediation has been observed to be experienced by many medical trainees. Research with regard to individualized remedial teaching based on pedagogical diagnosis is a strong need of the time. The objectives of this study were to assess the effect of remedial teaching in improving academic performance among poorly performing students in Pharmacology and to assess factors that could affect academic performance.MethodThe study was conducted in 2019. Academically poor performing students (&lt; 50 % marks in Pharmacology first sessional exam) were selected after getting informed consent. After obtaining baseline information and Study skills self-assessment inventory information from all students, academically poor performing students (53 students) were identified and they were randomized into two groups. One group (26 students) received academic support alone. The second group (27 students) received academic support, sessions on study skills, stress-coping strategies and counselling regarding their academic and non-academic problems.ResultsThe improvement in test scores among all participants of remedial sessions was statistically significant. Mean pre-test marks 5.27 ± 3.6 post test 14.63 ± 1.24 and the difference is statistically significant. Though apparently high 10.02 ± 3.25 Vs. 8.59 ± 3.55, the post intervention gain in scores is not statistically significant between Academic support + special package group Vs. Academic support alone group (P value 0.16)ConclusionTailored or individualised remediation measures can greatly enhance the academic performance of undergraduate medical students and help them make satisfactory progress on the course.</jats:sec

Effect of remedial teaching on academic performance of poorly performing students in pharmacology: a quasi experimental study

Background: Significant learning difficulties requiring remediation has been observed to be experienced by many medical trainees. Research with regard to individualized remedial teaching based on pedagogical diagnosis is a strong need of the time. The objectives of this study were to assess the effect of remedial teaching in improving academic performance among poorly performing students in pharmacology and to assess factors that could affect academic performance.Methods: The study was conducted in 2019. Academically poor performing students (&lt;50 % marks in pharmacology first sessional exam) were selected after getting informed consent. After obtaining baseline information and study skills self-assessment inventory information from all students, academically poor performing students (53 students) were identified and they were randomized into two groups. One group (26 students) received academic support alone. The second group (27 students) received academic support, sessions on study skills, stress-coping strategies and counselling regarding their academic and non-academic problems.Results: The improvement in test scores among all participants of remedial sessions was statistically significant. Mean pre-test mark was 5.27±3.6, post-test was 14.63±1.24 and the difference is statistically significant. Though apparently high 10.02±3.25 versus 8.59±3.55, the post intervention gain in scores is not statistically significant between academic support+special package group versus academic support alone group (p value 0.16).Conclusions: Tailored or individualized remediation measures can greatly enhance the academic performance of undergraduate medical students and help them make satisfactory progress on the course.</jats:p

COGNITIVE ADVERSE EFFECTS OF LACOSAMIDE IN PATIENTS WITH LOCALIZATION RELATED EPILEPSY - A PROSPECTIVE OBSERVATIONAL STUDY

Abstract Newer antiepileptic drugs (AEDs) offer favourable safety profiles than the previously used AEDs. Despite the introduction of many AEDs, a large number of patients continue to suffer from uncontrolled partial-onset seizures which have considerable impact on a patient’s quality of life. Lacosamide (LCM) is a third generation AED approved for adjunctive use in partial-onset seizures. Patients with epilepsy frequently experience cognitive dysfunctions due to a variety of factors. Because AEDs are the major therapeutic modality for epilepsy, the adverse effects of AEDs on cognition are important. Objectives To assess the adverse effects of lacosamide on cognition among patients with localization related epilepsy to whom lacosamide is given as adjuvant therapy. METHODOLOGY An open labelled prospective observational study in 22 patients who suffered from localization related epilepsy. Results Average Initial seizure frequency per month was 3.56 (SD 2.58) and median frequency 2.5 seizures per month. Range being 1-8 per month. At the final followup at 6months, only 2 persons experienced seizure and that too only single episodes. The difference in frequency is statistically significant (Wilcoxon Signed Ranks TestP &lt;0.001). All the pre and post lacosamide cognition scores showed statistically significant positive correlation in this study. Conclusion Excellent seizure control is observed in patients with refractory localization related epilepsy treated with lacosamide. Also, lacosamide has no serious adverse effects or drug interactions. In this study, it is observed that unlike many AEDs, lacosamide contributed to significant improvement in cognition and can improve the quality of life in such patients. </jats:sec

Cognitive Effects of Lacosamide in Patients with Drug Refractory Focal Epilepsy: A Prospective Observational Study

Objectives: This study was conducted to obtain data on the cognitive effects of lacosamide in Indian population. Methodology: An open labelled prospective observational study in 22 patients who suffered from focal epilepsy. Results: All the pre and post lacosamide cognition scores showed statistically significant positive correlation in this study. Average initial seizure frequency per month was 3.56 (SD 2.58) and median frequency 2.5 seizures per month. Range being 1-8 per month. At the final follow-up at 6months, 87.5% of the study subjects had no seizures. In the remaining12.5% of patients, reduction in seizure frequency was observed. The difference in frequency is statistically significant (Wilcoxon Signed Ranks TestP &lt;0.001). Conclusion: Excellent seizure control is observed in patients with refractory focal epilepsy treated with lacosamide. Also, lacosamide has no serious adverse effects or drug interactions. In this study, it is observed that unlike many AEDs, lacosamide contributed to significant improvement in cognition.</jats:p

Allogeneic Transplant and CAR-T Therapy After Autologous Transplant Failure in DLBCL: A Noncomparative Cohort Analysis

Allogeneic transplant (alloHCT) and chimeric antigen receptor modified (CAR)-T cell therapy are potentially cuarative options of diffuse large B-cell lymphoma (DLBCL) relapsing after an autologous (auto)HCT. Although the Center for International Blood and Marrow Transplant Research (CIBMTR) prognostic model can predict outcomes of alloHCT in DLBCL after autoHCT failure, corresponding models of CAR-T treatment in similar patient populations are not available. In this noncomparative registry analysis, we report outcomes of patients with DLBCL (≥18 years) undergoing a reduced intensity alloHCT or CAR-T therapy with axicabtagene ciloleucel during 2012 to 2019 after a prior auto-HCT failure and apply the CIBMTR prognostic model to CAR-T recipients. A total of 584 patients were included. The 1-year relapse, nonrelapse mortality, overall survival (OS), and progression-free survival for CAR-T treatment after autoHCT failure were 39.5%, 4.8%, 73.4%, and 55.7%, respectively. The corresponding rates in the alloHCT cohort were 26.2%, 20.0%, 65.6%, and 53.8%, respectively. The 1-year OS of alloHCT recipients classified as low-, intermediate- and high/very high-risk groups according to the CIBMTR prognostic score was 73.3%, 59.9%, and 46.3%, respectively (P = .002). The corresponding rates for low-, intermediate-, and high/very high-risk CAR-T patients were 88.4%, 76.4%, and 52.8%, respectively (P &lt; .001). This registry analysis shows that both CAR-T and alloHCT can provide durable remissions in a subset of patients with DLBCL relapsing after a prior autoHCT. The simple CIBMTR prognostic score can be used to identify patients at high risk of treatment failure after either procedure. Evaluation of novel relapse mitigations strategies after cellular immunotherapies are warranted in these high-risk patients

Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group (Pediatric Research, (2022), 91, 5, (1069-1077), 10.1038/s41390-021-01587-3)

Publisher Copyright: © 2023, The Author(s).Correction to: Pediatric Research (2021) 91:1069–1077; The following publication disclaimer was added to the article: “The publication reflects the author’s view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.” The original article has been corrected.publishersversionepub_ahead_of_prin

Estimation of tuberculosis incidence at subnational level using three methods to monitor progress towards ending TB in India, 2015–2020

Objectives We verified subnational (state/union territory (UT)/district) claims of achievements in reducing tuberculosis (TB) incidence in 2020 compared with 2015, in India.Design A community-based survey, analysis of programme data and anti-TB drug sales and utilisation data.Setting National TB Elimination Program and private TB treatment settings in 73 districts that had filed a claim to the Central TB Division of India for progress towards TB-free status.Participants Each district was divided into survey units (SU) and one village/ward was randomly selected from each SU. All household members in the selected village were interviewed. Sputum from participants with a history of anti-TB therapy (ATT), those currently experiencing chest symptoms or on ATT were tested using Xpert/Rif/TrueNat. The survey continued until 30 Mycobacterium tuberculosis cases were identified in a district.Outcome measures We calculated a direct estimate of TB incidence based on incident cases identified in the survey. We calculated an under-reporting factor by matching these cases within the TB notification system. The TB notification adjusted for this factor was the estimate by the indirect method. We also calculated TB incidence from drug sale data in the private sector and drug utilisation data in the public sector. We compared the three estimates of TB incidence in 2020 with TB incidence in 2015.Results The estimated direct incidence ranged from 19 (Purba Medinipur, West Bengal) to 1457 (Jaintia Hills, Meghalaya) per 100 000 population. Indirect estimates of incidence ranged between 19 (Diu, Dadra and Nagar Haveli) and 788 (Dumka, Jharkhand) per 100 000 population. The incidence using drug sale data ranged from 19 per 100 000 population in Diu, Dadra and Nagar Haveli to 651 per 100 000 population in Centenary, Maharashtra.Conclusion TB incidence in 1 state, 2 UTs and 35 districts had declined by at least 20% since 2015. Two districts in India were declared TB free in 2020