Queen Mary University Of London Research Articles

Factores y elementos de calidad percibidos por el profesorado participante en el plan de acción tutorial de universidades europeas

Las investigaciones centradas en el análisis del Plan de Acción Tutorial (PAT) de las diferentes universidades europeas prestan atención a la mejora del servicio de orientación ofrecido por los centros de Educación Superior. Este estudio tiene como objetivo detectar los factores y elementos que determinan una tutorización de calidad percibidos por el profesorado de universidades europeas. La investigación se enmarca dentro del Proyecto de Excelencia I+D Timonel[1] para la elaboración de un sistema de recomendación basado en necesidades de orientación y tutoría de alumnado y egresados. Un total de 48 profesores de la Universidad de Jaén (España), la Universidad de Granada (España), el Instituto Politécnico de Coimbra (Portugal) y la Queen Mary University of London (Reino Unido) participaron en grupos nominales y técnicas DAFO. Los resultados se mostraron en referencia a tres grandes dimensiones recogidas en el proyecto y definidas como principales tendencias de acción tutorial: Académica, Personal y Profesional, añadiendo una cuarta dimensión transversal detectada por los participantes en el análisis de los datos. Los participantes revelan cómo la formación del profesorado en términos de orientación, los conocimientos y experiencia de estos así como la implicación y compromiso tanto del tutor como del alumnado en la acción tutorial son algunos de los factores y elementos que determinan una tutorización de calidad. A pesar de las investigaciones y de las experiencias desarrolladas, muchos son los esfuerzos que deben realizarse para que la acción tutorial en universidades europeas adquiera la excelencia que requiere.[1] Proyecto I+D de Excelencia aprobado en la convocatoria de 2016 del Ministerio de Economía y Competitividad de España (Ref. EDU2016-75892-P). Participan las universidades de Jaén y Granada (España), Instituto Politécnico de Coimbra (Portugal) y Queen Mary University of London (Reino Unido). [1] Proyecto I+D de Excelencia aprobado en la convocatoria de 2016 del Ministerio de Economía y Competitividad de España (Ref. EDU2016-75892-P). Participan las universidades de Jaén y Granada (España), Instituto Politécnico de Coimbra (Portugal) y Queen Mary University of London (Reino Unido).

The temporal dimensions of Thinking Black: a comment

Abstract This commentary was delivered at the 2019 Historical Research/Wiley Lecture at Queen Mary University of London on 6 June 2019. It was followed by a conversation with Rob Waters.

Relationship Between Study Habits And Academic Achievement In Students Of Medical Sciences In Kermanshah-Iran [Letter

Relationship Between Study Habits And Academic Achievement In Students Of Medical Sciences In Kermanshah-Iran [Letter] Amaury Trockels, Eleanor Smith, Diana Velazquez-Pimentel Barts and the London, School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, UKCorrespondence: Amaury TrockelsBarts and the London, School of Medicine and Dentistry, Queen Mary University of London, 4 Newark Street, Whitechapel, London E1 2AT, UKEmail a.trockels@smd14.qmul.ac.uk Dear editorWe read with great interest the study by Jafari et al which explored the links between study habits and academic achievement of medical-science students.1 The study concluded that there was a significant albeit weak (r=0.235, p

384TiP - Effectiveness of olaparib plus trastuzumab in HER2[+], BRCA–mutated (BRCAm) or homologous recombination deficient (HRD) advanced breast cancer (ABC) patients (pts). The OPHELIA study

BackgroundIn the OlympiAD trial the use of poly(adenosine diphosphate–ribose) polymerase inhibitor (PARPi) olaparib resulted in better progression–free survival (PFS) than standard chemotherapy, which led to approval in germinal BRCAm (gBRCAm)/HER2[-] ABC pts. There is a potential therapeutic role for PARPis in pts with defective DNA repair. Preclinical data support a strong synergism with trastuzumab in HER2[+] cells that are sensitive to PARPis. This study will evaluate the efficacy and safety of olaparib plus trastuzumab in HER2[+] gBRCAm or wild–type gBRCA/HRD ABC pts. Trial designThis is a multicenter, single–arm, two–cohort, Simon’s two–stage, phase II trial. The cohort A will recruit N=20 gBRCAm ABC pts. The cohort B will recruit N=13 wild–type gBRCA/HRD ABC pts based on HRDetect assay. Pts will receive olaparib (300mg p.o. b.i.d. during 21–day cycles) in combination with trastuzumab (IV/SC at standard dose) until progression or unacceptable toxicity. Main selection criteria: (1) Pre– and post–menopausal women with HER2[+] ABC; (2) ≤3 prior regimens of chemotherapy and/or trastuzumab–lapatinib in advanced setting, and at least 1 regimen of chemotherapy including trastuzumab; (3) Pts treated with carboplatin or platinum compounds in the last 12 months are not eligible; (4) Evaluable or measurable disease. Co–Primary objectives: Overall response rate (ORR) and PFS of olaparib plus trastuzumab in the cohort A. In the cohort A (N=20), we plan a Simon’s two–stage design (7 pts in the 1st stage and 13 pts in the 2nd stage in case of any responder in 1st stage). Final ORR will be promising with ≥4 responders among 18 evaluable pts (H0: ORR≤5%; HA: ORR≥30%). PFS estimation will be based a one–arm log–rank test (H0: PFS≤3–months; HA: PFS≥6–months). These give us an 80% power at 0.025 one–sided alpha level. In the cohort B (N=13) ORR will be promising with ≥3 responders among 13 pts (p<0.025; H0: ORR≤5%). Secondary objectives: Safety–related outcomes, clinical benefit rate, overall survival, and quality of life. Exploratory objectives: Prevalence of gBRCAm and HRD in HER2[+] ABC, and identification of new potential predictive markers. Clinical trial identificationNCT03931551. First Posted: April 30, 2019. Legal entity responsible for the studyMedica Scientia Innovation Research (MedSIR); Experior. FundingAstraZeneca Famacéutica Spain S.A. DisclosureJ.A. García-Sáenz: Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis, Celgene, Eli Lilly, EISAI, Roche; Research grant / Funding (institution): AstraZeneca; Travel / Accommodation / Expenses: Novartis, Roche, Pfizer. J. Balmana: Advisory / Consultancy: AstraZeneca, Pfizer. E. López-Miranda: Full / Part-time employment: Medica Scientia Innovation Research (MedSIR). J. Cortés: Advisory / Consultancy: Roche, Celgene, Cellestia, AstraZeneca, Biothera Pharmaceutical, Merus, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex; Honoraria (institution): Roche, Novartis, Celgene, Eisai, Pfizer, Samsung; Research grant / Funding (institution): Roche, Ariad pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer healthcare, Eisai, F.Hoffman-La Roche, Guardanth health, Merck Sharp&Dohme, Pfizer, Piqur Therapeutics, Puma C, Queen Mary University of London; Advisory / Consultancy, Shareholder / Stockholder / Stock options, Officer / Board of Directors: Medica Scientia Innovation Research (MedSIR). A. Llombart Cussac: Honoraria (institution), Advisory / Consultancy: Roche, GlaxoSmithKline, Novartis, Celgene, Eisai, AstraZeneca; Research grant / Funding (institution): GlaxoSmithKline, Sanofi, Puma Biotechnology; Advisory / Consultancy, Shareholder / Stockholder / Stock options, Officer / Board of Directors: Medica Scientia Innovation Research (MedSIR). All other authors have declared no conflicts of interest.

347P - Multicenter phase I trial of trastuzumab emtansine (T-DM1) in combination with non-pegylated liposomal doxorubicin (NPLD) in HER2[+] metastatic breast cancer (MBC). THELMA study

BackgroundEMILIA, TH3RESA, and KAMILLA phase III trials showed that T-DM1 is highly active and safe as single agent in HER2[+] MBC. T-DM1 and NPLD may be safely combined to increase antitumor effect compared to each agent alone. The aim of this trial is to determine the dose-limiting toxicity (DLT) and maximum tolerate dose (MTD) of T-DM1 plus NPLD in HER2[+] MBC. MethodsA 3 + 3 dose escalation design was used. Main selection criteria were: (1) Women with HER2[+] MBC ≥ 18 years (yrs); (2) Patients (pts) relapsed or progressed on or after taxanes and trastuzumab-based therapy; (3) No prior treatment with T-DM1 or anthracyclines; (4) Measurable or non-measurable disease with bone lesions. The initial dose was T-DM1 (3.6mg/kg IV) plus NPLD (45mg/m2 IV) on Day 1, q3w for up to 6 cycles of NPLD (cohort 1). In the next dose levels, only the NPLD dose was increased to 50mg/m2 (cohort 2) and 60mg/m2 (cohort 3). The MTD was the highest dose level at which 0/3 pts or≤1/6 pts experienced DLT during the first 2 cycles. Six additional pts were enrolled at the MTD. T-DM1 treatment was continued as a single agent until disease progression or intolerable toxicity. Secondary objectives included safety, efficacy, and pharmacokinetic (PK) profile. ResultsFifteen pts were enrolled (cohort 1, n=3; cohort 2, n=3; and cohort 3 [NPLD 60mg/m2 as MTD], n=9). Median age was 49.5 yrs (range, 31-62), 26.7% received ≥2 prior metastatic treatments, and 80% included trastuzumab plus pertuzumab combination. The only DLT was in the cohort 3 (neutrophil count <0.5x109/L lasted 13 days). The most common ≥G3 adverse events (AEs) were neutropenia (53.3%), AST increase (13.3%), and thrombocytopenia (13.3%). No ≥G3 cardiac AEs occurred. The median duration of treatment and relative dose intensity were 3.7 months and 85%, respectively. The median progression-free survival (mPFS), overall response rate (ORR), and clinical benefit rate (CBR) was 7.2 months, 40%, and 46.7%, respectively. The mPFS, ORR, and CBR in cohort 3 was 7.2 months, 33.3%, and 44.4%, respectively. The analysis of PK profile is ongoing. ConclusionsT-DM1 plus NDLP is a safe and active combination for pts with previously treated HER2[+] MBC. Clinical trial identificationNCT02562378. First Posted: September 29, 2015. Legal entity responsible for the studyMedica Scientia Innovation Research (MedSIR); Experior. FundingRoche Pharma AG. DisclosureE. López-Miranda: Full / Part-time employment: Medica Scientia Innovation Research (MedSIR). S. Di Cosimo: Speaker Bureau / Expert testimony: Novartis; Advisory / Consultancy: Pfizer, TEVA, EpiOnpharma, Bayer; Travel / Accommodation / Expenses: Roche, GSK, Celgene; Advisory / Consultancy, Grant reviewer compensation: Swiss Cancer League; Research grant / Funding (institution): EISAI. E. Brain: Research grant / Funding (institution): TEVA (Cephalon), HalioDX (Qiagen/Ipsogen), Amgen; Honoraria (institution), Advisory / Consultancy: AstraZeneca, BMS, Celgene, Clinigen, Hospira, Janssen, Mylan, OBI Pharma, Pfizer, Puma, Roche, Samsung. M. Ravnik: Advisory / Consultancy, Board member: Roche; Advisory / Consultancy, Board member: Pfizer; Advisory / Consultancy, Board member: Eli Lilly; Advisory / Consultancy, Board member: Merck. S. Escrivá-de-Romaní: Advisory / Consultancy: Roche, Pierre Fabre; Speaker Bureau / Expert testimony: Roche, Pierre-Fabre, Kyowa-Kirin, Eisai, Celgene; Travel / Accommodation / Expenses: Roche, Daiichi Sankyo, Pierre Fabre. L. Calabuig: Full / Part-time employment: Medica Scientia Innovation Research (MedSIR). M. Sampayo: Full / Part-time employment: Medica Scientia Innovation Research (MedSIR). J.M. Pérez-García: Advisory / Consultancy: Roche, Lilly; Full / Part-time employment: Medica Scientia Innovation Research (MedSIR). F. Riva: Full / Part-time employment: Medica Scientia Innovation Research (MedSIR). A. Malfettone: Full / Part-time employment: Medica Scientia Innovation Research (MedSIR). A. Llombart Cussac: Honoraria (self), Advisory / Consultancy: Roche, GlaxoSmithKline, Novartis, Celgene, Eisai, AstraZeneca; Research grant / Funding (self): GlaxoSmithKline, Sanofi, Puma Biotechnology; Leadership role, Shareholder / Stockholder / Stock options, Officer / Board of Directors: Medica Scientia Innovation Research (MedSIR). J. Cortés: Advisory / Consultancy: Roche, Celgene, Cellestia, AstraZeneca, Biothera Pharmaceutical, Merus, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex; Honoraria (institution): Roche, Novartis, Celgene, Eisai, Pfizer, Samsung.; Research grant / Funding (institution): Roche, Ariad pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer healthcare, Eisai, F.Hoffman-La Roche, Guardanth health, Merck Sharp&Dohme, Pfizer, Piqur Therapeutics, Puma C, Queen Mary University of London; Advisory / Consultancy, Shareholder / Stockholder / Stock options, Officer / Board of Directors: Medica Scientia Innovation Research (MedSIR). All other authors have declared no conflicts of interest.

387TiP - Palbociclib rechallenge in hormone receptor (HR)[+]/HER2[-] advanced breast cancer (ABC). PALMIRA trial

BackgroundThe combination of a CDK4/6 inhibitor (CDK4/6i) with letrozole (LET) or fulvestrant (FUL) is the most active first–line (1L) treatment for patients (pts) with HR[+]/HER2[-] ABC. Although endocrine sensitivity persists beyond progression, preliminary findings suggest more adaptive resistance mechanisms to endocrine therapy (ET) than to CDK4/6i. At present, there are no data about prolonging CDK4/6 blockade beyond progression on a CDK4/6i. The aim of this study is to determine whether palbociclib rechallenge combined with second–line ET upon progression to a prior palbociclib–based therapy will improve progression–free survival (PFS) over ET alone in HR[+]/HER2[-] ABC pts. Trial designThis is an international, open–label, randomized phase II trial. A total of 198 pts will be randomized (2:1) to palbociclib plus ET (LET or FUL) or ET alone, until progressive disease (PD) or unacceptable toxicity. Pts will be stratified by 1L ET and presence of visceral metastasis. Main selection criteria include: (1) Pre– and post–menopausal women with HR[+]/HER2[-] ABC; (2) Evidence of PD on a 1L combination of palbociclib plus LET or FUL after obtaining clinical benefit (secondary resistance); (3) Pts relapsing on or within the first year of a palbociclib–based adjuvant regimen; (4) Measurable and biopsable disease or non–measurable disease with bone lesion. The primary objective is to assess PFS of palbociclib plus ET versus ET alone. The 1st co-primary endpoint is the PFS in the combination arm only. If this objective is achieved, we will compare PFS between the two arms (2nd co-primary endpoint). With 128 events, the 1st and 2nd analyses have an 80% power to detect a 1.4–month (hazard ratio [HR]=0.74) or 2.74–month (HR=0.6) increase over 4–month median PFS for ET arm, respectively. The nominal alpha level is 5% for two-sided log-rank tests. Secondary objectives evaluate: Safety–related outcomes, objective response rate, 6–month clinical benefit rate, overall survival, quality of life, and time to first chemotherapy. Exploratory objectives include: Correlation between the intrinsic molecular subtypes and efficacy/safety findings, and identification of new predictive markers. Clinical trial identificationNCT03809988. First Posted: January 18, 2019. Legal entity responsible for the studyMedica Scientia Innovation Research (MedSIR). FundingPfizer S.L.U. DisclosureA. Llombart Cussac: Honoraria (institution), Advisory / Consultancy: Roche, GlaxoSmithKline, Novartis, Celgene, Eisai, AstraZeneca; Research grant / Funding (institution): GlaxoSmithKline, Sanofi, Puma Biotechnology; Advisory / Consultancy, Shareholder / Stockholder / Stock options, Officer / Board of Directors: Medica Scientia Innovation Research (MedSIR). P. Schmid: Advisory / Consultancy: Pfizer, AstraZeneca, Novartis, Merck, Boehringer Ingelheim, Bayer, Eisai, Celgene, Puma; Research grant / Funding (institution): AstraZeneca, Genentech, Roche, Oncogenex, Novartis, Astellas; Spouse / Financial dependant, Spouse is consulting for Genentech/Roche: Genentech/Roche. I. Macpherson: Honoraria (self): Celldex, Daiichi Sankyo, Eisai, Genomic Health, Novartis, Pfizer, Roche; Travel / Accommodation / Expenses: Eisai, Roche. J. Gligorov: Advisory / Consultancy: Daïchi, EISAI, Genomic Health, Ipsen, Macrogenics, MSD, Novartis, Onxeo, Pfizer, Roche Genentech; Travel / Accommodation / Expenses: EISAI, Genomic Health, MSD, Novartis, Pfizer, Roche Genentech; Non-remunerated activity/ies: Daichi, EISAI, Genomic Health, Immunomedics, Novartis, Pfizer, Roche Genentech. M. Sampayo: Full / Part-time employment: Medica Scientia Innovation Research (MedSIR). F. Riva: Full / Part-time employment: Medica Scientia Innovation Research (MedSIR). A. Malfettone: Full / Part-time employment: Medica Scientia Innovation Research (MedSIR). J.M. Pérez-García: Advisory / Consultancy: Roche, Lilly; Full / Part-time employment: Medica Scientia Innovation Research (MedSIR). J. Cortés: Advisory / Consultancy: Roche, Celgene, Cellestia, AstraZeneca, Biothera Pharmaceutical, Merus, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex; Honoraria (institution): Roche, Novartis, Celgene, Eisai, Pfizer, Samsung; Research grant / Funding (institution): Roche, Ariad pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer healthcare, Eisai, F.Hoffman-La Roche, Guardanth health, Merck Sharp&Dohme, Pfizer, Piqur Therapeutics, Puma C, Queen Mary University of London; Advisory / Consultancy, Shareholder / Stockholder / Stock options, Officer / Board of Directors: Medica Scientia Innovation Research (MedSIR). All other authors have declared no conflicts of interest.

Supported accommodation for people with mental health problems: the QuEST research programme with feasibility RCT

Background Across England, around 60,000 people live in mental health supported accommodation: residential care, supported housing and floating outreach. Residential care and supported housing provide on-site support (residential care provides the highest level), whereas floating outreach staff visit people living in their own tenancies. Despite their abundance, little is known about the quality and outcomes of these services. Objectives The aim was to assess the quality, costs and effectiveness of mental health supported accommodation services in England. The objectives were (1) to adapt the Quality Indicator for Rehabilitative Care (QuIRC) and the Client Assessment of Treatment scale for use in mental health supported accommodation services; (2) to assess the quality and costs of these services in England and the proportion of people who ‘move on’ to less supported accommodation without placement breakdown (e.g. to move from residential care to supported housing or supported housing to floating outreach, or, for those receiving floating outreach, to manage with fewer hours of support); (3) to identify service and service user factors (including costs) associated with greater quality of life, autonomy and successful move-on; and (4) to carry out a feasibility trial to assess the required sample size and appropriate outcomes for a randomised evaluation of two existing models of supported accommodation. Design Objective 1 – focus groups with staff (n = 12) and service users (n = 16); psychometric testing in 52 services, repeated in 87 services (adapted QuIRC) and with 618 service users (adapted Client Assessment of Treatment scale). Objectives 2 and 3 – national survey and prospective cohort study involving 87 services (residential care, n = 22; supported housing, n = 35; floating outreach, n = 30) and 619 service users followed over 30 months; qualitative interviews with 30 staff and 30 service users. Objective 4 – individually randomised, parallel-group feasibility trial in three centres. Setting English mental health supported accommodation services. Participants Staff and users of mental health supported accomodation services. Interventions Feasibility trial involved two existing models of supported accommodation: supported housing and floating outreach. Main outcome measures Cohort study – proportion of participants who successfully moved to less supported accommodation at 30 months’ follow-up without placement breakdown. Feasibility trial – participant recruitment and withdrawal rates. Results The adapted QuIRC [QuIRC: Supported Accomodation (QuIRC-SA)] had excellent inter-rater reliability, and exploratory factor analysis confirmed its structural validity (all items loaded onto the relevant domain at the > ± 0.3 level). The adapted Client Assessment of Treatment for Supported Accommodation had good internal consistency (Cronbach’s alpha 0.89) and convergent validity (rs = 0.369; p Conclusions We did not find clear evidence on the most effective model(s) of mental health supported accommodation. Indeed, our feasibility study suggests that trials comparing effectiveness cannot be conducted in this country. A range of options are required to provide appropriate support to individuals with differing needs. Future work Future research in this field requires alternatives to trials. Service planners should be guided by the mental health needs of the local population and the pros and cons of the different services that our study identified, rather than purely financial drivers. Trial registration Current Controlled Trials ISRCTN19689576. Funding This programme was funded by the National Institute for Heath Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 7, No. 7. See the NIHR Journals Library website for further project information. The fundholders are Camden and Islington NHS Foundation Trust and the research is a collaboration between University College London, Queen Mary University of London, King’s College London, the University of Ulster and Durham University.

Type 2 diabetes and Parkinson's disease

Type 2 diabetes and Parkinson's disease

Acting in the Public Interest: Learnings and Commentary on the Occupational Licensure Literature

There is increased interest in reforming the way occupations are licensed. However, most of the current dialogue focuses on the rapid growth in the number of people who need a license to pursue their chosen occupation. Consequently, significant questions are being raised as to the appropriateness of such requirements for groups that do not appear to present any tangible threat to public safety. Recent research has demonstrated that health professions have failed to articulate the need and value for licensure and how health regulators are addressing the many concerns being raised by the current debate. This study identifies dimensions or aspects of nurse licensure congruent with acting in the public interest and starts to curate (ie, to select, organize, and present) evidence related to each dimension, thereby identifying the current impact and highlighting opportunities for further research. This study utilizes a mixed-methods approach that combines documentary analysis, focus group discussion, and related literature associated with the various dimensions of acting in the public interest to highlight how nurse licensure addresses the current drivers for regulatory reform. A total of 99 documentary sources (ie, papers, articles, reports, and opinion editorials) were uploaded to NVivo 11 Plus for analysis. The analysis generated four overarching themes: (a) licensure reform, (b) impact of occupational associations, (c) occupational licensure issues, and (d) contemporary issues. Associated with these themes, 22 subthemes were also identified. The findings demonstrate there is clear evidence to support the fact that nurse regulators are acting in the public interest. However, further research is needed to provide definitive evidence to inform best practices in regulation and to offer direction for improved nurse regulatory reform. Furthermore, it is suggested that nurse regulators create and effectively maintain a global community capable of learning from one another and driving continuous improvement to better serve the public.

Factors influencing adherence to vacuum-formed retainer wear: A qualitative study.

To explore factors influencing adherence to vacuum-formed retainer wear over a minimum period of four years. A qualitative study based on a randomised controlled trial assessing the effectiveness of orthodontic retainers. Institute of Dentistry, Queen Mary University of London. Fifteen participants wearing vacuum-formed retainers for at least four years. One-to-one semi-structured interviews were undertaken on a criterion-based purposive sample of participants wearing vacuum-formed retainers. The interviews were audio-recorded, transcribed verbatim and analysed using Framework Methodology. High self-reported levels of adherence in the early stages of retention were linked to a desire to maintain orthodontic outcomes and the negative perception of potential post-treatment changes. However, adherence typically reduced over time due to a combination of factors including the negative impact of retainers on quality of life and pragmatic issues related to retainer wear. Network support was found to be important in the short and long term, with instances of self-directed wear and negative beliefs concerning the importance of retainer wear and predisposition to post-treatment changes. Lack of follow-up appointments and immaturity of participants prompted independent decisions to cease retainer wear. Six key influencers of prolonged adherence with vacuum-formed retainer wear were identified. Future strategies to improve adherence should account for these while also being responsive to time elapsed since debond and patient age.

First person – Ioannis Xanthis

ABSTRACT First Person is a series of interviews with the first authors of a selection of papers published in Journal of Cell Science, helping early-career researchers promote themselves alongside their papers. Ioannis Xanthis is first author on ‘β1 integrin is a sensor of blood flow direction’, published in JCS. Ioannis conducted the research described in this article while a PhD student in Prof. Paul Evans's lab at IICD, University of Sheffield Medical School, Sheffield, UK. He is now a postdoctoral research assistant in lab of Dr Thomas Iskratsch at the School of Engineering and Materials Science, Queen Mary University of London, London, UK, investigating vascular biomechanics and bioengineering.

Paola Domizio: gifted pathology teacher and science communicator

Paola Domizio, the pathologist and professor who has died from breast cancer, may be the only person to have incorporated card tricks into her inaugural professorial lecture. It was typical of the flair she brought to her teaching role at Barts and the London School of Medicine and Dentistry at Queen Mary University of London and to her ambassadorial and leadership positions with the Royal College of Pathologists. Having served as assistant registrar and then registrar for a total of nine years from 2001, Domizio deployed her communication skills and zest for the specialty as director of public engagement at the college from 2011. Concerned that the public’s view of pathology was shaped by TV crime solving sleuths in pristine white coats, running between antiseptic laboratory and faintly exotic murder scenes, she wrote articles and took to television and radio herself to redress the balance. It was during this period that the college adopted the strapline “Pathology: the science behind the cure.” This was in the 1990s, and Domizio was among those to take on the discredited former doctor and antivaccine activist Andrew Wakefield, writing two articles challenging his research methods and conclusions around links between the measles, mumps, and rubella vaccine and autism. Domizio may also have been the first clinician to offer children who had undergone colectomies for bowel disease the opportunity to view and learn about the bowel resection tissue that had caused their distressing symptoms. She …

Strategic Patenting and Evergreening in Pharmaceutical Sector: Competition Law as a Panacea

This is a dissertation submitted by me for my Masters of Law at Queen Mary University of London. It is a comprehensive study of the pharmaceutical sector in relation to consumer protection whilst considering the excessive price affliction on the availability of affordable health services. It focus on anti-competitive agreements like cartels, parallel pricing, predatory pricing by pharmaceutical companies including other aspects under competition law and patients being fettered by patents under intellectual property laws. Drugs being an essential commodity have been part of unfair-trade practices and its implication is leading to extensive price discrimination on a global level. The study highlights the outlook of World Health Organization, Medicines Sans Frontiers and other organizations on international price discrimination and ban of several drugs in various countries while consumption in other leading to disparity in health care. This will involve the legal steps initiated by the international organizations for consumer welfare. It will be a comparative analysis of implementation of laws in different jurisdictions for availability of drugs at fair price which will include the legal hurdles in promotion and adoption of low-cost generic drugs by various jurisdictions. The primary objective of this dissertation is capitalist approach of pharmaceutical companies in defeating the larger public interest and the discrepancies of law leading to ethical misconducts. Context • Chapter I Medicines and analysis of problems related to Pharmaceutical sector 1.1 The significance and need for medicines 1.2 Types of medicines present in the market and their features 1.3 Participants involved in the pharmaceutical markets 1.4 Pricing and accessibility 1.5 Examining the instances related to patents in Pharmaceutical sector • Chapter II Overview of IP Laws in the Pharmaceutical sector 2.1 The role of IP Laws and the theory of innovation (Protection of Patentee) 2.2 Evergreening as distinctive innovation 2.3 Strategic patenting by Pharmaceutical Companies 2.4 Effect on the pricing of drugs and the availability of generic medicines due to patent protections 2.5 Role of TRIPS Agreement created by WTO • Chapter III Overview of Competition Law in Pharmaceutical sector 3.1 Meaning and its liaison with IP Laws 3.2 Relevant market for pharmaceuticals 3.3 Coherence of IP Laws and Competition Law 3.4 Predatory pricing and Strategic patenting 3.5 Other anti-competitive agreements • Chapter IV International directives on Pharmaceutical sector 4.1 Guidelines for developing countries 4.2 Jurisdictional analysis 4.2.1 EU 4.2.2 USA 4.2.3 India 4.3 WHO • Conclusion

Health Outcomes, Pathogenesis and Epidemiology of Severe Acute Malnutrition (HOPE-SAM): rationale and methods of a longitudinal observational study

IntroductionMortality among children hospitalised for complicated severe acute malnutrition (SAM) remains high despite the implementation of WHO guidelines, particularly in settings of high HIV prevalence. Children continue to be at...

Pembrolizumab Plus Chemotherapy as Neoadjuvant Treatment for Locally Advanced Triple-Negative Breast Cancer: Results from the Phase 1b Open-Label, Multicohort KEYNOTE-173 Study

Background: The phase 1b KEYNOTE-173 study assessed the safety and preliminary antitumour activity of neoadjuvant chemotherapy plus pembrolizumab in locally advanced non-metastatic triple-negative breast cancer (TNBC). Methods: Six pembrolizumab plus chemotherapy regimens were evaluated (cohorts A–F). All cohorts received a pembrolizumab 200-mg run-in dose (cycle 1), followed by 8 cycles of pembrolizumab in combination with a taxane with or without carboplatin for 12 weeks and then doxorubicin and cyclophosphamide for additional 12 weeks before surgery. Primary endpoints were safety and recommended phase 2 dose (RP2D); secondary endpoints were pathological complete response (pCR) rate, objective response rate (ORR), event-free and overall survival. Exploratory endpoints included the relationship between outcome and potential biomarkers, such as tumour programmed death ligand 1 (PD-L1) expression (combined positive score [CPS]) and stromal tumour-infiltrating lymphocyte levels (sTILs). Study is registered with ClinicalTrials.gov, NCT02622074. Findings: Sixty patients were enrolled between February 18, 2016 and February 28, 2017. Dose-limiting toxicities occurred in 22 patients, most commonly febrile neutropenia (n=9 across cohorts). Four cohorts (B, C, D, F) did not meet the RP2D threshold, whereas 2 cohorts did (A, E). The most common grade ≥3 treatment-related adverse event was neutropenia (73%). Immune-mediated adverse events and infusion reactions occurred in 18 patients (30%), which were grade ≥3 in six patients (10%). The pCR rate (ypT0/Tis ypN0) across all cohorts was 60% (range, 30%–80%). 12-month event-free and overall survival rates ranged from 80% to 100% across cohorts (100% for four cohorts). Higher pre-treatment PD-L1 CPS, and pre- and on-treatment sTILs were significantly associated with higher pCR rates (P = 0.0127, 0.0059, and 0.0085, respectively). Interpretation: The combination of neoadjuvant chemotherapy with pembrolizumab for locally advanced TNBC showed manageable toxicity and promising antitumour activity. In an exploratory analysis, pCR rate showed positive correlation with tumour PD-L1 expression and sTIL levels. Funding: Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Declaration of Interest: PS has received grants from AstraZeneca, Roche, Genentech, Oncogenex, Novartis, Astellas and consulting fees from Pfizer, AstraZeneca, Novartis, Roche, Merck, Boehringer Ingelheim, Bayer, and Puma Biotechnology. His spouse has received consulting fees from Genentech and Roche. RS received research support for the scoring of sTILs presented in this manuscript. YHP has received grants, personal fees and non-financial support from Pfizer, Eisai, and Roche, personal fees and nonfinancial support from Merck, grants and personal fees from Novartis, personal fees from Celgene, and non-financial support from Hanmi. SBK has received grants from Novartis, Sanofi-Aventis, Kyowa-Kirin Inc, and DongKook Pharm Co and has received consulting fees from Novartis, AstraZeneca, Lilly, Enzychem, Dae Hwa Pharmaceutical Co. Ltd, ISU Abxis, and Daiichi-Sankyo. JS has received grants from Merck, Roche, Novartis, AstraZeneca, Lilly, Pfizer, Bayer, GlaxoSmithKline, CONTESSA, and Daiichi Sankyo. TF has received grants and consulting fees (as institutional payments) from Pfizer, grants from Roche, and royalties for authorship from Wolters Kluwer Health (UpToDate). SK has received personal fees from Roche, Genomic Health, Lilly, Novartis, Amgen, Celgene, Daiichi Sankyo, AstraZeneca, Somatex, Merck, Pfizer, Puma Biotechnology, and PFM Medical and non-financial support from Roche and Daiichi Sankyo. RD has received personal fees from AstraZeneca, Eisai, Lilly, Merck, Novartis, Pfizer, Roche, and Seattle Genetics. JC has received grants (as institutional payments) from Roche, Ariad Pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer Healthcare, Eisai, F. Hoffman-La Roche, Guardant Health, Merck, Pfizer, Piqur Therapeutics, Puma Biotechnology, Queen Mary University of London, and Seagen, consulting fees from Roche, Celgene, Cellestia, AstraZeneca, Biothera Pharmaceutical, Merus, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Servier, Merck, GlaxoSmithKline, and Leuko, and honoraria from Roche, Novartis, Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, Merck, and Daiichi Sankyo. SL has received grants (as institutional payments) from Novartis, Bristol-Myers Squibb, Merck, Roche-Genentech, Puma Biotechnologyand Eli Lilly, has acted as a consultant (not compensated) for Seattle Genetics, Pfizer, Novartis, BMS, Merck, AstraZeneca and Roche-Genentech and has received consulting fees (to institution) from Aduro Biotech. EMC has nothing to disclose. LY, AW, KT, and VK are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Ethical Approval: The study protocol was approved by the appropriate institutional review board or independent ethics committee at each participating institution. The study was conducted in accordance with the protocol, good clinical practice guidelines, provisions of the Declaration of Helsinki and all local regulations. All patients provided written informed consent to participate.

Cove

Cove Hannah Comer (bio) COVE, the Central Online Victorian Educator, originally constituted in 2016, is a scholar-driven, open-access platform, maintained and supported by the North American Victorian Studies Association (NAVSA), the British Association for Victorian Studies (BAVS), and the Australasian Victorian Studies Association (AVSA), as well as by a number of independent institutions including Purdue, Texas Christian University, the University of Delaware, Ryerson University, Carleton University, the University of Alberta–Birkbeck, the University of Exeter, Queen Mary University of London, and the University of Birmingham. COVE is designed to support and publish all Victorian materials that are considered important for the understanding of the period and to support teaching through innovative tools and the publication of material that can be used creatively. COVE publishes peer-reviewed material, provides tools to guide Victorian research and pedagogy, and advocates interest in the humanities. The platform cultivates and explores the possibilities of digital technologies, opening up new ways of understanding the period through editions of various Victorian works (see https://editions.covecollective.org/content/about-cove). Current COVE poetry editions, among others, include Christina Rossetti’s “Goblin Market” (1862), Oscar Wilde’s “The Harlot’s House” (1885 Wilde’s “The Harlot’s House” (1904), Elizabeth Barratt Browning’s “On a Portrait of Wordsworth by B. R. Haydon” (1842) and Rossetti’s “In An Artist’s Studio” (1856 “In An Artist’s Studio” (1896). The digital edition of Rossetti’s “Goblin Market” (https://editions.covecollective.org/edition/goblin-market) is the work of a team of eight current Rossetti scholars: Antony Harrison, Lorraine Janzen Kooistra, Mary Arseneau, Alison Chapman, Margaret Linley, Emma Mason, and Richard Menke. This edition aims to provide an authoritative text with critical commentary that explores the linguistic, textual, historical, cultural, and interpretative aspects of the poem. It features both a biographical introduction to Rossetti and an editorial introduction to the text. The biographical introduction outlines Rossetti’s life and work, her involvement within the Pre-Raphaelite circle, and the formative influences on her visual and poetic imagination. Both introductions trace the reception of Rossetti’s work, from after her death to current critical interest and research, acknowledging her position as an important Victorian poet. The editorial introduction lists the other important editions of the poem printed since 1862. It features editions such as the volume with accompanying illustrations by her [End Page 455] brother Dante Gabriel Rossetti and Rebecca Crump’s three-volume variorum edition, The Complete Poems of Christina Rossetti (1979–1990). This edition also incorporates the notes supplied by Christina Rossetti’s brother William Michael Rossetti and thus reconsiders his role as the editor of both her and D. G. Rossetti’s poetical works. The annotations and commentary for the poem encompass the various approaches to “Goblin Market,” using categorical (such as linguistic, textual, historical) and color-coded tags to show the variants in the text and provide biographical and cultural information about Rossetti and the Victorian era. The interpretive tag displays further information about Rossetti’s poetic techniques or influences, visual and musical responses to the poem, and the critical reception of Rossetti’s poem. Each color-coded tag shows the annotator’s name and the category or categories under which he or she falls. Wilde’s “The Harlot’s House” (https://editions.covecollective.org/edition/harlots-house), edited and annotated by Dennis Denisoff, Regenia Gagnier, Natalie Houston, Jamil Mustafa, Diana Maltz, Stefano Evangelista, and Dominique Gracia, is an edition that reconsiders “The Harlot’s House” as an example of a theater poem. The introduction to the text gives a brief overview of Wilde’s formative years and his involvement in the Aesthetic Movement and primarily focuses on his work as a poet as well as his theatrical work and interests. In the introduction, Denisoff and Gagnier explore the social issues and contexts, particularly prostitution, that inform Wilde’s poem. It features a list of primary, critical, and visual works cited. This edition establishes the poem’s editorial history from its original publication in the 1885 Dramatic Review and two privately printed versions of the text in 1904 and 1905 and fosters a virtual and scholarly community through which the poem can be kept on...

The intercalated BSc in sports and exercise medicine at Barts and The London School of Medicine and Dentistry

To report about the intercalated Bsc(Hons) in Sports and Exercise Medicine at Barts and The London School of Medicine and Dentistry (BLSMD), Queen Mary University of London. Educational study. The course is currently in its tenth year, providing medical students with the opportunity to develop knowledge in the field of Sports and Exercise Medicine (SEM) during one academic year of full time study. There have been more than 150 graduates, and 22 students are enrolled for the 2012-13 academic year on what has been the most popular and largest intercalated degree at BLSMD in recent years. External applicants typically make up 30-40% of entrants. Equal weighting on taught modules and a portfolio of research activity provides a strong foundation in Sports and Exercise Medicine, and equips successful students with evidence based translational skills, and the opportunity to perform publishable research. This article outlines the increasing demand for Sports and Exercise Medicine education, and how the course prepares graduates for practising SEM as a sub-specialist interest or to compete for entry into the Specialist Trainee training route.

London calling Gaza: The role of international collaborations in the globalisation of postgraduate burn care education.

Burn injuries represent a significant epidemiological problem, with the vast majority occurring in low- to middle-income countries. These regions also represent areas where lack of socioeconomic growth and geopolitical instability pose additional barriers not only to healthcare provision but also to the acquisition of continuing professional development. Long-distance, web-based learning programmes (‘tele-education’) have been identified as a successful and powerful means of propagating up-to-date medical education and training in poor-resource, isolated or conflict-ridden regions.This report evaluates the role of tele-education in delivering a distance-learning Master’s degree in Burn Care to a group of 11 healthcare professionals working in the occupied Palestinian territories (OPT), which was funded as part of a collaboration between Queen Mary University of London and IMET-Pal (International Medical Education Trust – Palestine).We present our experience in delivering the programme in a conflict-ridden part of the world, which includes the specific adaptations to tailor the programme to regional needs as well the unique challenges faced by students and faculty in enhancing the educational value of this unique initiative.The academic achievements of this group of healthcare professionals were found to be comparable to historical student cohorts from privileged socioeconomic backgrounds and the majority of students felt that participation in the programme contributed to a direct improvement to their daily burn care practices.The successful outcomes achieved by our students support the constantly emerging evidence that targeted, well-delivered, long-distance learning programmes can become powerful tools in combating inequalities in global healthcare and health education.

Third-Party Funding in Investment Treaty Arbitration: Revisiting the Findings of the ICCA-Queen Mary Task Force

The emergence of third-party funding in investor-state dispute settlement adds to the problems and challenges already facing a dispute resolution regime whose compatibility with sustainable economic and social development goals, if not its entire legitimacy, has been called into question. A task force jointly constituted by ICCA and Queen Mary University of London recently produced a report in which it articulated principles relating to disclosure and conflicts of interest, privilege and professional secrecy, the allocation of costs, and security for costs, which were intended to introduce clarity and consistency into third-party-funding practices in international arbitration. Although promising in some respects, the principles were conservative in others. This article identifies some shortcomings in the principles put forward by the task force and proposes adjustments to some of their conservative aspects. In so doing, it touches on the broader question of the suitability of third-party funding to investor-state dispute settlement, given the system’s particularities.

Development of a Data Portal for Aggregation and Analysis of Genomics Data in Familial Platelet Disorder with Predisposition to Myeloid Malignancy - the RUNX1.DB

Development of a Data Portal for Aggregation and Analysis of Genomics Data in Familial Platelet Disorder with Predisposition to Myeloid Malignancy - the RUNX1.DB