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Beecham, L. "Local medical committee conference." BMJ 309, no. 6946 (July 2, 1994): 60–62. http://dx.doi.org/10.1136/bmj.309.6946.60.
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Kowark, Ana, Christian Adam, Jörg Ahrens, Malek Bajbouj, Cornelius Bollheimer, Matthias Borowski, Richard Dodel, et al. "Improve hip fracture outcome in the elderly patient (iHOPE): a study protocol for a pragmatic, multicentre randomised controlled trial to test the efficacy of spinal versus general anaesthesia." BMJ Open 8, no. 10 (October 2018): e023609. http://dx.doi.org/10.1136/bmjopen-2018-023609.
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IntroductionHip fracture surgery is associated with high in-hospital and 30-day mortality rates and serious adverse patient outcomes. Evidence from randomised controlled trials regarding effectiveness of spinal versus general anaesthesia on patient-centred outcomes after hip fracture surgery is sparse.Methods and analysisThe iHOPE study is a pragmatic national, multicentre, randomised controlled, open-label clinical trial with a two-arm parallel group design. In total, 1032 patients with hip fracture (>65 years) will be randomised in an intended 1:1 allocation ratio to receive spinal anaesthesia (n=516) or general anaesthesia (n=516). Outcome assessment will occur in a blinded manner after hospital discharge and inhospital. The primary endpoint will be assessed by telephone interview and comprises the time to the first occurring event of the binary composite outcome of all-cause mortality or new-onset serious cardiac and pulmonary complications within 30 postoperative days. In-hospital secondary endpoints, assessed via in-person interviews and medical record review, include mortality, perioperative adverse events, delirium, satisfaction, walking independently, length of hospital stay and discharge destination. Telephone interviews will be performed for long-term endpoints (all-cause mortality, independence in walking, chronic pain, ability to return home cognitive function and overall health and disability) at postoperative day 30±3, 180±45 and 365±60.Ethics and disseminationiHOPE has been approved by the leading Ethics Committee of the Medical Faculty of the RWTH Aachen University on 14 March 2018 (EK 022/18). Approval from all other involved local Ethical Committees was subsequently requested and obtained. Study started in April 2018 with a total recruitment period of 24 months. iHOPE will be disseminated via presentations at national and international scientific meetings or conferences and publication in peer-reviewed international scientific journals.Trial registration numberDRKS00013644; Pre-results
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Zavala, Gerardo A., Krishna Prasad-Muliyala, Faiza Aslam, Deepa Barua, Asiful Haidar, Catherine Hewitt, Rumana Huque, et al. "Prevalence of physical health conditions and health risk behaviours in people with severe mental illness in South Asia: protocol for a cross-sectional study (IMPACT SMI survey)." BMJ Open 10, no. 10 (October 2020): e037869. http://dx.doi.org/10.1136/bmjopen-2020-037869.
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IntroductionPeople with severe mental illness (SMI) die on average 10–20 years earlier than the general population. Most of these deaths are due to physical health conditions. The aim of this cross-sectional study is to determine the prevalence of physical health conditions and their associations with health-risk behaviours, health-related quality of life and various demographic, behavioural, cognitive, psychological and social variables in people with SMI attending specialist mental health facilities in South Asia.Methods and analysisWe will conduct a survey of patients with SMI attending specialist mental health facilities in Bangladesh, India and Pakistan (n=4500). Diagnosis of SMI will be confirmed using the Mini-international neuropsychiatric interview V.6.0. We will collect information about physical health and related health-risk behaviours (WHO STEPwise approach to Surveillance (STEPS)); severity of common mental disorders (Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder scale (GAD-7)) and health-related quality of life (EQ-5D-5L). We will measure blood pressure, height, weight and waist circumference according to WHO guidelines. We will also measure glycated haemoglobin, lipid profile, thyroid function, liver function, creatinine and haemoglobin. Prevalence rates of physical health conditions and health-risk behaviours will be presented and compared with the WHO STEPS survey findings in the general population. Regression analyses will explore the association between health-risk behaviours, mental and physical health conditions.Ethics and disseminationThe study has been approved by the ethics committees of the Department of Health Sciences University of York (UK), Centre for Injury Prevention and Rehabilitation (Bangladesh), Health Ministry Screening Committee and Indian Council of Medical Research (India) and National Bioethics Committee (Pakistan). Findings will be disseminated in peer-reviewed articles, in local and international conferences and as reports for policymakers and stakeholders in the countries involved.Trial registration numberISRCTN88485933; 3 June 2019.
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Liu, Yue-E., Xiao-Ying Xue, Rui Zhang, Xue-Ji Chen, Yu-Xia Ding, Chao-Xing Liu, Yue-Liang Qin, Wei-Qian Li, Xiao-Cang Ren, and Qiang Lin. "Study protocol: a multicentre, prospective, phase II trial of isotoxic hypofractionated concurrent chemoradiotherapy for non-small cell lung cancer." BMJ Open 10, no. 10 (October 2020): e036295. http://dx.doi.org/10.1136/bmjopen-2019-036295.
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IntroductionConcurrent chemoradiotherapy with conventional fractionation has been acknowledged as one of the standard treatments for locally advanced non-small cell lung cancer (NSCLC). The radiotherapy dose of 60 Gy is far from enough for local tumour control. Due to this fact, hypofractionated radiotherapy can shorten the total treatment duration, partially counteract the accelerated repopulation of tumour cells and deliver a higher biological effective dose, it has been increasingly used for NSCLC. In theory, concurrent hypofractionated chemoradiotherapy can result in an enhanced curative effect. To date, the vast majority of radiotherapy prescriptions assign a uniform radiotherapy dose to all patients. However this kind of uniform radiotherapy prescription may lead to two consequences: excess damage to normal tissues for large tumours and insufficient dose for small tumours. Our study aims to evaluate whether delivering individualised radiotherapy dose is feasible using intensity-modulated radiotherapy.Methods and analysisOur study of individualised radiotherapy is a multicenter phase II trial. From April 2019, a total of 30 patients from three Chinese centres, with a proven histological or cytological diagnosis of inoperable NSCLC, will be recruited. The dose of radiation will be increased until one or more of the organs at risk tolerance or the maximum dose of 69 Gy is reached. The primary end point is feasibility, with response rates, progression-free survival and overall survival as secondary end points. The concurrent chemotherapy regimen will be docetaxel plus lobaplatin.Ethics and disseminationThe study has been approved by medical ethics committees from three research centres. The trial is conducted in accordance with the Declaration of Helsinki.The trial results will be disseminated through academic conference presentations and peer-reviewed publications.Trial registration numberNCT03606239
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Mills, Jonathan, David Wordsworth, and Kieran Sharrock. "Local Medical Committees." InnovAiT: Education and inspiration for general practice 11, no. 11 (September 28, 2018): 649–50. http://dx.doi.org/10.1177/1755738018792291.
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Nagai, Yoji, Shinsuke Kojima, Hisatomo Kowa, Yasuji Yamamoto, Hiroyuki Kajita, Tohmi Osaki, Yasumasa Kakei, Kavita U. Kothari, and Ryoma Kayano. "Kobe project for the exploration of newer strategies to reduce the social burden of dementia: a study protocol of cohort and intervention studies." BMJ Open 11, no. 6 (June 2021): e050948. http://dx.doi.org/10.1136/bmjopen-2021-050948.
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IntroductionThis research project addresses the lack of screening tools for the early detection of high-risk individuals for long-term care, through four individual studies.Study 1 investigates the predictive ability of the ‘Kihon Check List’, study 2 the ‘Cognitive Function instrument’ and EuroQol-5 Dimension (EQ-5D) and study 3 the ‘Cognitive Function instrument’ and EQ-5D as well as the ‘Frail Kenshin’ health check-up, for incident long-term care certification over a follow-up period of up to 4 years. This is the first large prospective study to evaluate the predictive ability of these tools for the outcome measure long-term care certification. The last subsection of this project study four aims to explore a mixed methods intervention for delaying the need for long-term care. This section is purely exploratory, looking for clues for further studies.Methods and analysisBaseline data have been collected through local government programs, as well as through postal self-reported questionnaires. The primary outcome variable for all studies is long-term care certification data. Statistical analysis will be carried out using Kaplan-Meier, Multiple Cox regression as well as logistic regression.ConclusionThis project hopes to identify tools effective in predicting long-term care need. This will enable identification of citizens that are of higher risk for long-term care in the near future. This subset of high-risk individuals can in the future be addressed for extra support/intervention.Ethics and disseminationAll studies have been approved by respective institutional ethical committees and the WHO ethical committee ERC.0002899. In addition, all studies conform to the provisions of the Declaration of Helsinki and are conducted in accordance with Japan’s ‘Ethical Guidelines for Medical and Health Research Involving Human Subjects’. All findings will be disseminated at conferences and published in peer-reviewed journals.Trial registration numberUMIN000023283.
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Richters, Anke, Minke S. Nieuwboer, Marieke Perry, Marcel G. M. Olde Rikkert, Rene J. F. Melis, and Marjolein A. van der Marck. "Evaluation of DementiaNet, a network-based primary care innovation for community-dwelling patients with dementia: protocol for a longitudinal mixed methods multiple case study." BMJ Open 7, no. 8 (August 2017): e016433. http://dx.doi.org/10.1136/bmjopen-2017-016433.
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IntroductionPrimary healthcare professionals will increasingly be required to manage and optimise their treatment for patients with dementia. With DementiaNet, we aim to reduce the burden of dementia on healthcare services and society through implementation and facilitation of integrated network-based care with increased dementia expertise. DementiaNet is designed as a stepwise approach including clinical leadership, quality improvement cycles and interprofessional training, which are tailor-made to the local context. For example, the composition of the network and improvement goals are tailored to the local context and availability. Here, we describe the linked evaluation study which aims to provide insight in effectiveness, process and mechanism of the DementiaNet approach through an innovative evaluation design.Methods and analysisWe designed a longitudinal, mixed methods, multiple case study. Study population consists of two levels: (i) local DementiaNet networks of primary care professionals and (ii) patients and informal caregivers who receive care from these networks. At the start and after 12 and 24 months, quantitative data are collected for each network on: level of network maturity, quality of care indicators and outcomes reported by informal caregivers of dementia patients. We assess changes in networks over time and the association with quality of care and informal caregiver-reported outcomes. Throughout the study, logs about each network are registered. Additionally, semi-structured interviews with network members and informal caregivers will provide insight in experiences and opinions regarding effects and mechanisms through which changes in quantitative outcomes are effectuated. Rich narratives will be constructed about the development of the local networks using collected data.Ethics and disseminationThe study protocol was reviewed by the local medical ethics committee; formal judgement was not required (protocol number: 2015–2053). The findings of this study will be disseminated through peer-reviewed publications, conference presentations and presentations for healthcare professionals where appropriate.
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Horwitz, Steven M., Owen A. O'Connor, Barbara Pro, Tim M. Illidge, Michelle A. Fanale, Ranjana H. Advani, Nancy L. Bartlett, et al. "The ECHELON-2 Trial: Results of a Randomized, Double-Blind, Active-Controlled Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients with CD30+ Peripheral T-Cell Lymphomas." Blood 132, Supplement 1 (November 29, 2018): 997. http://dx.doi.org/10.1182/blood-2018-99-110563.
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Abstract Background Peripheral T-cell lymphomas (PTCLs) are a heterogeneous group of aggressive non-Hodgkin lymphomas (NHL). PTCL accounts for approximately 10% of all NHL cases in the US and Europe, and may be as high as 24% in Asia. The most common frontline treatment of PTCL is anthracycline-based chemotherapy with CHOP or CHOP-like regimens which do not produce durable remissions in the majority of subtypes, including ALK+ systemic anaplastic large cell lymphoma (sALCL) with high International Prognostic Index (IPI) scores. Brentuximab vedotin is an antibody-drug conjugate directed against CD30 currently approved for the treatment of relapsed or refractory sALCL with demonstrated antitumor activity in frontline PTCL. A phase 1 trial combining brentuximab vedotin with cyclophosphamide, doxorubicin, and prednisone (CHP [CHOP without vincristine to eliminate additive neurotoxicity]) as frontline treatment of PTCL demonstrated estimated 5-year progression-free survival (PFS) and overall survival (OS) rates of 52% and 79% (Fanale 2018). Based on the encouraging activity and manageable safety profile of the combination, the ECHELON-2 trial was initiated to compare the efficacy and safety of brentuximab vedotin in combination with CHP (A+CHP) versus standard CHOP for the treatment of patients (pts) with PTCL (ClinicalTrials.gov No. NCT01777152). Here we report the blinded, pooled analyses per investigator of the ECHELON-2 trial. Methods ECHELON-2 is a phase 3, randomized, double-blind, active-controlled, multicenter study. Adults with newly diagnosed CD30+ (≥10% of neoplastic cells by local review) PTCL were enrolled. Pts with ALK+ sALCL were required to have an IPI ≥2. The primary endpoint of ECHELON-2 is PFS per an independent review facility. Pts were randomized 1:1 to receive 21-day cycles of either CHOP or A+CHP for 6 to 8 cycles. Consolidative SCT or radiotherapy was permitted at the investigator's discretion after end of treatment. Results A total of 452 pts across 17 countries were randomized between January 2013 and November 2016 in Europe (44%), North America (29%), and other (26%) regions including Asia and Australia. The median age was 58 years (range, 18-85) and 63% were male. Most pts were white (62%) or Asian (22%). Most pts entering the study had an ECOG performance status of 0 or 1 (39% each) and the remaining 22% of pts had a performance status of 2. Most pts had advanced-stage disease (Stage III [27%] or IV [53%]) at diagnosis and 78% had IPI scores ≥2 (2 [34%], 3 [29%], 4 [12%]. 5 [3%]). PTCL subtypes included sALCL (316 pts [70%]: ALK+ 98 pts [22%]; ALK- 218 pts [48%]), PTCL - not otherwise specified (72 pts [16%]), angioimmunoblastic T-cell lymphoma (54 pts [12%]), adult T-cell leukemia/lymphoma (7 pts [2%]), and enteropathy-associated T-cell lymphoma (3 pts [1%]). Of the 452 randomized pts, 449 received at least 1 dose of study treatment and all pts had either completed (82%) or discontinued treatment as of April 2017. Treatment was discontinued for adverse events (AEs) (7%), progressive disease (7%), investigator decision (2%), and patient decision (2%). Preliminary results by investigator assessment, show an overall blinded pooled objective response rate (ORR) following completion of the frontline treatment of 79% (95% CI: 75.4-83.1) with 64% achieving a complete response (CR) (95% CI: 59.1-68.2). With a median follow-up of 35.2 mos, the 3-year PFS and OS for all pts were 52.9% (95% CI: 47.7-57.7) and 73.1% (95% CI: 68.3-77.2). The incidence of AEs was consistent with the known safety profiles of brentuximab vedotin and CHOP chemotherapy, including the AE of interest, peripheral sensory neuropathy (43%). Grade 3 or higher AEs reported in ≥10% of pts were neutropenia (33%), febrile neutropenia (17%), and anemia (12%). Conclusions ECHELON-2 is the largest prospective, randomized, double-blind study to compare the efficacy and safety of standard CHOP with an alternative regimen that includes a CD30-targeted agent in frontline treatment of sALCL and other CD30+ PTCLs. Blinded pooled data from ECHELON-2 show that the treatment was well tolerated with encouraging 3-year PFS and OS rates. The primary analysis by treatment regimen will be unblinded prior to the meeting and presented at the conference. Disclosures Horwitz: Seattle Genetics: Consultancy, Research Funding; Aileron Therapeutics: Consultancy, Research Funding; Innate Pharma: Consultancy; Millennium/Takeda: Consultancy, Research Funding; Forty Seven: Consultancy, Research Funding; Corvus: Consultancy; Mundipharma: Consultancy; ADC Therapeutics: Consultancy, Research Funding; Trillium: Consultancy; Celgene: Consultancy, Research Funding; Portola: Consultancy; Infinity/Verastem: Consultancy, Research Funding; Spectrum: Research Funding; Kyowa-Hakka-Kirin: Consultancy, Research Funding. O'Connor:Seattle Genetics: Research Funding; Celgene: Research Funding; ADC Therapeutics: Research Funding. Pro:kiowa: Honoraria; Takeda Pharmaceuticals: Honoraria, Other: Travel expenses; Seattle Genetics: Consultancy, Other: Travel expenses, Research Funding; portola: Honoraria. Illidge:Nordic Nanovector: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Consultancy, Research Funding; Takeda: Consultancy, Honoraria. Fanale:Amgen: Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel expenses, Research Funding; Bristol-Myers Squibb: Consultancy, Honoraria, Other: Travel expenses, Research Funding; Merck & Co: Consultancy, Honoraria, Other: Travel expenses, Research Funding; Takeda: Honoraria, Other: Travel expenses, Research Funding. Advani:Agensys: Research Funding; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Membership on an entity's Board of Directors or advisory committees, Other: Participated in an advisory board, Research Funding; Astra Zeneca: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Participated in an advisory board; Merck: Research Funding; Janssen: Research Funding; Autolus: Membership on an entity's Board of Directors or advisory committees, Other: Participated in an advisory board; Celgene: Research Funding; Kyowa: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Participated in an advisory board; Regeneron: Research Funding; Pharmacyclics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Infinity: Research Funding; Kura: Research Funding; Celgene: Research Funding; Roche/Genentech: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Participated in an advisory board, Research Funding; Gilead/Kite: Membership on an entity's Board of Directors or advisory committees, Other: Participated in an advisory board; Cell Medica: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Participated in an advisory board; Millenium: Research Funding; Seattle Genetics: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Participated in an advisory board, Research Funding; Forty Seven Inc.: Research Funding; Bayer: Membership on an entity's Board of Directors or advisory committees, Other: Participated in an advisory board. Bartlett:KITE: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Research Funding; Astra Zeneca: Research Funding; Pharmacyclics: Research Funding; Seattle Genetics: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; ImaginAB: Research Funding; Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Merck & Co: Research Funding; Immune Design: Research Funding; Acerta: Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Genentech: Research Funding; Forty Seven: Research Funding; Affimed: Research Funding; Celgene: Research Funding; Novartis: Research Funding; Pharmacyclics: Research Funding; Novartis: Research Funding; Bristol-Meyers Squibb: Research Funding; Millennium: Research Funding. Christensen:Seattle Genetics: Research Funding. Morschhauser:Janssen: Other: Scientific Lectures; BMS: Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Epizyme: Consultancy; Roche: Membership on an entity's Board of Directors or advisory committees; Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees. Domingo-Domenech:Affimed: Research Funding. Rossi:Novartis: Honoraria; Jazz: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees; Sanofi: Membership on an entity's Board of Directors or advisory committees; Teva: Membership on an entity's Board of Directors or advisory committees; Gilead: Membership on an entity's Board of Directors or advisory committees, Other: Travel expenses; Amgen: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees, Other: Travel expenses; Janssen: Membership on an entity's Board of Directors or advisory committees, Travel expenses; Roche: Membership on an entity's Board of Directors or advisory committees; BMS: Honoraria; Mundipharma: Honoraria; Sandoz: Honoraria; Seattle Genetics: Research Funding; Alexion: Other: Travel expenses. Feldman:Portola: Research Funding; Celgene: Speakers Bureau; Pharmacyclics: Speakers Bureau; Seattle Genetics: Research Funding, Speakers Bureau; KITE: Speakers Bureau; Johnson and Johnson: Speakers Bureau; Janssen: Speakers Bureau. Lennard:Janssen: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Research Funding. Belada:Janssen-Cilag: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Seattle Genetics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Gilead Sciences: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. Illés:Takeda: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees. Tobinai:Zenyaku Kogyo: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding; Eisai: Honoraria, Research Funding; Ono Pharmaceutical: Honoraria, Research Funding; SERVIER: Research Funding; Abbvie: Research Funding; GlaxoSmithKline: Research Funding; Takeda: Honoraria, Research Funding; Mundipharma: Honoraria, Research Funding; Kyowa Hakko Kirin: Honoraria, Research Funding; HUYA Bioscience International: Consultancy, Honoraria; Chugai Pharma: Honoraria, Research Funding; Janssen: Honoraria, Research Funding. Tsukasaki:Celgene: Honoraria; Eisai: Research Funding; Chugai Pharma: Honoraria, Research Funding; HUYA: Consultancy, Research Funding; Ono Pharma: Consultancy; Daiich-Sankyo: Consultancy; Mundy Pharma: Honoraria; Kyowa-hakko/Kirin: Honoraria; Seattle Genetics: Research Funding. Yeh:GNT Biotech & Medicals Crop.: Research Funding. Shustov:Seattle Genetics: Research Funding. Hüttmann:Roche: Other: Travel expenses; Celgene: Other: Travel expenses. Savage:Verastem: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Seattle Genetics: Consultancy, Honoraria, Research Funding; Merck: Consultancy, Honoraria; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria; Servier: Consultancy. Yuen:Seattle Genetics: Research Funding. Zinzani:MSD: Honoraria, Speakers Bureau; Celltrion: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; SERVIER: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Astra Zeneca: Speakers Bureau; Verastem: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Merck: Honoraria, Membership on an entity's Board of Directors or advisory committees; TG Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees; PFIZER: Honoraria, Membership on an entity's Board of Directors or advisory committees; TG Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bayer: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; PFIZER: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bayer: Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Speakers Bureau; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Merck: Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Hua:Takeda Pharmaceuticals International Co.: Employment. Little:Takeda Pharmaceuticals: Employment. Rao:Seattle Genetics: Employment, Equity Ownership. Woolery:Seattle Genetics: Employment, Equity Ownership. Manley:Seattle Genetics: Employment, Equity Ownership. Trümper:Seattle Genetics: Research Funding.
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Neill, Lorna, Strachan C. Mackenzie, Maria A. V. Marzolini, William Townsend, Kirit M. Ardeshna, Kate Cwynarski, Surjo De, et al. "Steroid Use, Advanced Stage Disease and ≥3 Lines of Prior Chemotherapy Are Associated with a Higher Risk of Infection Following CD19 CAR T-Cell Therapy for B-NHL: Real World Data from a Large UK Center." Blood 136, Supplement 1 (November 5, 2020): 20–21. http://dx.doi.org/10.1182/blood-2020-138865.
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Background: Tisagenlecleucel (Tisagen) and Axicabtagene Ciloleucel (Axicel) CD19 CAR T-cell products are licensed in the UK for adults with relapsed/refractory high-grade B-cell Non-Hodgkin's lymphoma (B-NHL). Infection rates for the first 30 days post CAR T range from 23% (Hill et al, Blood 2018) to 42% (Park et al, Clin Infect Dis 2018) with a predominance of early bacterial infections. Infection etiology is multifactorial, including pre-existing immunosuppression, poor marrow reserve, concomitant disease, delayed cytopenias and lymphodepletion. CRS has been shown to be an independent risk factor and associated treatment (Tocilizumab, steroids) may contribute. Risk assessment is limited by heterogenous cohorts in published reports and practice variations in use of prophylactic antibiotics and intravenous immunoglobulin (IVIG). To determine incidence and outcome of infection with licensed CAR T-cell products, we conducted a retrospective review at UCLH, London, UK. Methods: Electronic medical records were used to collect data on patients treated with Tisagen/Axicel from May 2019 to July 2020. Infections at ≤28 days and >28days following infusion were recorded. Infections were defined as a positive microbiological/virology result in conjunction with clinical symptoms. Invasive fungal infections were classified according to revised EORTC criteria. Infections were graded as severe (requiring systemic treatment) or life threatening (hypotension/organ support). Results: Sixty adults with B-NHL received Tisagen (n=19) or Axicel (n=41). Patients did not receive prophylactic antibiotics. IVIG was given for hypogammaglobulinaemia with recurrent infections (n=4). Within 28 days of infusion, 44 episodes of infection occurred in 28 patients (47%). Post day 28 (range 29-452), 19 episodes occurred in 9 patients (15%). Severe (n=9) and life-threatening (n=7) infection occurred in 15% and 12% of patients respectively, with two infections resulting or contributing to death (3.3%). Infections were bacterial (56%), respiratory viral (24%), other viral (14%) and fungal (6%). Six (10%) developed viral reactivations; CMV (n=1), BK virus in blood or urine (n=2), HHV6 (n=1) or AdV (n=2). PCR proven JC virus causing progressive multifocal leukoencephalopathy was reported in 1 patient at day 116. Only one late COVID-19 infection occurred despite the program remaining operational throughout lockdown. There was no association between early infection and CRS severity (p=0.43), or use (p=0.94) and dose of Tocilizumab (p=0.54). With regard to pre-treatment variables, advanced disease at time of infusion (≥stage 3) was associated with higher risk of any infection (OR 4.2, 95% CI 1.3- 13.4, p=0.016) and lines of prior therapy (≥3) with higher risk of early infection (OR 3.0, 95% CI 1.0-8.9, p=0.048). Steroid treatment was associated with a higher risk of early (and overall) infection (OR 3.0. 95% CI 1.0-8.6, p=0.048). A diagnosis of ICANS was associated with infection beyond day 30 (p=0.021). In multivariate analyses, steroid use (p=0.03) and ≥3 lines of prior therapy (p=0.021) were associated with infection ≤28 days of infusion. Steroid use (p= 0.049) and stage pre infusion (p=0.023) were associated with higher risk of any infection. Conclusion: In this real world analysis of B-NHL patients treated with Tisagen or Axicel, 47% developed early infection at ≤28 days. Severe or life-threatening infection occurred in 27% of patients. Multivariate analysis confirms significant association with (1) steroid exposure (2) ≥stage 3 disease and (3) ≥3 lines of previous therapy. There was no overt association with Tocilizumab use or CRS severity. Unlike other centers, our cohort did not receive prophylactic antibiotics or IVIG. Patients with advanced disease are high risk for CRS, ICANS and infectious complications. Risk modification strategies include bridging optimization to reduce disease burden pre CAR T with infectious prophylaxis from referral until at least 3-6 months post-infusion. In this analysis, steroids represent a significant risk and efforts should be made to wean doses swiftly. The use of steroid sparing agents such as Anakinra may be important (clinical trial results awaited). In ≥ stage 3 disease or heavily pre-treated patients, there may be a role for prophylactic antibiotics but this should be explored within a clinical study with consideration of local antimicrobial resistance patterns. Disclosures Neill: Novartis: Other: Funded attendance at academic conferences; Celgene: Other: Funded attendance at academic conferences. Townsend:Roche, Gilead: Consultancy, Honoraria. Ardeshna:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Beigene: Membership on an entity's Board of Directors or advisory committees; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees; ADC Therapeutics: Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi, Genzyme, AstraZeneca: Speakers Bureau; University College London (UCL)/UCL Hospitals (UCLH) Biomedical Research Unit: Other: Supported by this organisation. Cwynarski:Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Travel Support, Speakers Bureau; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Atara: Consultancy, Membership on an entity's Board of Directors or advisory committees; Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; KITE: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Travel Support, Speakers Bureau; Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Travel Support, Speakers Bureau; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Travel Support. Peggs:Autolus: Consultancy. Roddie:Celgene: Honoraria; Gilead: Honoraria; Novartis: Honoraria. O'Reilly:Gilead: Honoraria; Novartis: Honoraria, Other: Travel support.
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Manchia, Mirko, Pasquale Paribello, Carlo Arzedi, Alberto Bocchetta, Paola Caria, Cristina Cocco, Donatella Congiu, et al. "A multidisciplinary approach to mental illness: do inflammation, telomere length and microbiota form a loop? A protocol for a cross-sectional study on the complex relationship between inflammation, telomere length, gut microbiota and psychiatric disorders." BMJ Open 10, no. 1 (January 2020): e032513. http://dx.doi.org/10.1136/bmjopen-2019-032513.
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IntroductionSevere psychiatric disorders are typically associated with a significant reduction in life expectancy compared with the general population. Among the different hypotheses formulated to explain this observation, accelerated ageing has been increasingly recognised as the main culprit. At the same time, telomere shortening is becoming widely accepted as a proxy molecular marker of ageing. The present study aims to fill a gap in the literature by better defining the complex interaction/s between inflammation, age-related comorbidities, telomere shortening and gut microbiota in psychiatric disorders.Methods and analysisA cross-sectional study is proposed, recruiting 40 patients for each of three different diagnostic categories (bipolar disorder, schizophrenia and major depressive disorder) treated at the Section of Psychiatry and at the Unit of Clinical Pharmacology of the University Hospital Agency of Cagliari (Italy), compared with 40 age-matched and sex-matched non-psychiatric controls. Each group includes individuals suffering, or not, from age-related comorbidities, to account for the impact of these medical conditions on the biological make-up of recruited patients. The inflammatory state, microbiota composition and telomere length (TL) are assessed.Ethics and disseminationThe study protocol was approved by the Ethics Committee of the University Hospital Agency of Cagliari (PG/2018/11693, 5 September 2018). The study is conducted in accordance with the principles of good clinical practice and the Declaration of Helsinki, and in compliance with the relevant Italian national legislation. Written, informed consent is obtained from all participants. Participation in the study is on a voluntary basis only. Patients will be part of the dissemination phase of the study results, during which a local conference will be organised and families of patients will also be involved. Moreover, findings will be published in one or more research papers and presented at national and international conferences, in posters or oral communications.
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Rapport, Frances, Patti Shih, Rebecca Mitchell, Armin Nikpour, Andrew Bleasel, Geoffrey Herkes, Sanjyot Vagholkar, and Virginia Mumford. "Better evidence for earlier assessment and surgical intervention for refractory epilepsy (The BEST study): a mixed methods study protocol." BMJ Open 7, no. 8 (August 2017): e017148. http://dx.doi.org/10.1136/bmjopen-2017-017148.
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IntroductionOne-third of patients with refractory epilepsy may be candidates for resective surgery, which can lead to positive clinical outcomes if efficiently managed. In Australia, there is currently between a 6-month and 2-year delay for patients who are candidates for respective epilepsy surgery from the point of referral for surgical assessment to the eventual surgical intervention. This is a major challenge for implementation of effective treatment for individuals who could potentially benefit from surgery. This study examines implications of delays following the point of eligibility for surgery, in the assessment and treatment of patients, and the factors causing treatment delays.Methods and analysisMixed methods design: Observations of qualitative consultations, patient and healthcare professional interviews, and health-related quality of life assessments for a group of 10 patients and six healthcare professionals (group 1); quantitative retrospective medical records’ reviews examining longitudinal outcomes for 50 patients assessed for, or undergoing, resective surgery between 2014 and 2016 (group 2); retrospective epidemiological study of all individuals hospitalised with a diagnosis of epilepsy in New South Wales (NSW) in the last 5 years (2012–2016; approximately 11 000 hospitalisations per year, total 55 000), examining health services’ use and treatment for individuals with epilepsy, including refractory surgery outcomes (group 3).Ethics and disseminationEthical approval has been granted by the North Sydney Local Health District Human Research Ethics Committee (HREC/17/HAWKE/22) and the NSW Population & Health Services Research Ethics Committee (HREC/16/CIPHS/1). Results will be disseminated through publications, reports and conference presentations to patients and families, health professionals and researchers.
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Dymond, John H. "Preface." Pure and Applied Chemistry 77, no. 8 (January 1, 2005): iv. http://dx.doi.org/10.1351/pac20057708iv.
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The 18th IUPAC International Conference on Chemical Thermodynamics (ICCT-2004), concurrent with the 12th National Conference on Chemical Thermodynamics and Thermal Analysis, was held 17-21 August 2004 at the Fragrant Hill Hotel, Beijing, China. Professor Haike Yan was Conference Chair, Prof. Zhiwu Yu was Conference Co-chair, and Prof. Xibai Qiu was Secretary. The 395 participants came from 40 countries.During the official opening ceremony, there was a presentation of the first Doctorate Awards to be given by the International Association of Chemical Thermodynamics, with sponsorship from Elsevier. The three recipients were Dr. Lin Chen, Tsinghua University, Beijing; Mr. Dirk Wandschneider, University of Rostock, Germany; and Mr. Weiguo Xu, Liaoning University, China. They each received a certificate plus a cash prize of USD 500.The conference began with the Rossini lecture, presented by Prof. Jean-Pierre E. Grolier on "Advanced experimental techniques in polymer thermodynamics". The conference program consisted of eight symposia and three workshops. In Symposium 1, Electrolyte and Nonelectrolyte Solution Thermodynamics, Prof. Emmerich Wilhelm gave the plenary lecture "The fascinating world of pure and mixed nonelectrolytes". There were invited lectures by Profs. Eckhard Vogel, Fumio Hirata, and Takayoshi Kimura. In Symposium 2, New Materials, Prof. C. Richard Catlow presented the plenary lecture "Computational approaches to the catalytic activation of carbon-hydrogen bonds", and invited lectures were given by Profs. Mary Anne White and Vladimir Durov. The plenary lecture in Symposium 3, Phase Equilibrium, Supercritical Fluids, and Separation Technologies, was given by Prof. Pablo Debenedetti on "Thermodynamics of supercooled and glassy water", with invited lectures from Profs. Cornelis Peters and Ding-Yu Peng. Symposium 4, Biological, Medical, Pharmaceutical, Agricultural, and Food Thermodynamics, had as its plenary lecturer Prof. Stephan Grzesiek, who spoke on "Biomolecular interactions in solutions". Professors Lee Hansen and Ichiro Hatta were the invited lecturers.Symposium 5 was on Colloid and Interface Science. Professor Bernard Cabane presented the plenary lecture "Solid-liquid separation", and there were invited lectures from Dr. Gerd Olofsson and Profs. Watson Loh and Xueqin An. The title of Symposium 6 was Non-equilibrium Thermodynamics, Statistical Thermodynamics, and Molecular Simulation. The plenary lecture "Non-equilibrium pattern formation" was presented by Prof. Qi Ouyang, with an invited lecture by Prof. Zhen-Gang Wang. Symposium 7 considered Thermochemistry and Molecular Energetics, with Prof. Michio Sorai, the plenary lecturer, speaking on "Entropy diagnosis for phase transitions occurring in functional materials". Professor Juliana Boerio-Goates gave the invited lecture. Symposium 8 was on Industrial Thermodynamics and Data Bases. Dr. Michael Fenkel gave the plenary lecture on "Global communications and expert systems in thermodynamics: Connecting property measurement and chemical process design". Invited lectures were given by Profs. Pertti Koukkari and Zhoulan Yin.There were three workshops. Prof. Kazuya Saito was invited lecturer for the Workshop on Thermodynamic Frontiers and Education. Professors Joan Brennecke and Andreas Heintz were invited lecturers for the Ionic Liquids Workshop. Professors Joon Won Park and Junko Morikawa gave invited lectures at the Workshop on New Experimental Techniques, including Nanotechnology.In addition, there were over 180 oral presentations, spread over the symposia and workshops, and about 280 poster presentations.The Rossini lecture and plenary lectures, with the exception of the paper by Prof. P. Debenetti where the field was recently reviewed [1,2], are published in this issue, together with the invited paper by Prof. Lee Hansen entitled "A thermodynamic law of adaptation of plants to environmental temperatures". Selected papers from individual symposia will be published in the Journal of Molecular Liquids (Symposium 1), Fluid Phase Equilibria (Symposia 3 and 6), the Journal of Chemical Thermodynamics (Symposia 1, 2, and 7), Thermochimica Acta (Symposium 4), or in the Journal of Chemical and Engineering Data (Workshop on Ionic Liquids).After the previous weeks when it had been very hot and humid, the temperature dropped and the weather was most pleasant for the conference. This change in weather, together with the attractive setting of the hotel, the excellent hospitality, which included a welcome reception, an evening of acrobatics entertainment, a conference banquet in the Summer Palace, and the high standard of the presentations, made this conference memorable. In addition, there was a full program of tours for accompanying persons. Our thanks are extended to the Conference Chair and Co-chair, and to all members of the local Organizing Committee, the International Advisory Committee, and the International Scientific Committee. We are most grateful to IUPAC, the International Association of Chemical Thermodynamics, the China Association for Science and Technology, the National Natural Science Foundation of China, and the Chinese Academy of Sciences for sponsoring the conference.Thermodynamics will continue to be an important area of research for many years to come, with a wide range of applications from chemical engineering to the biosciences. We look forward to the presentation and discussion of the results of further advances in chemical thermodynamics at the next ICCT, which will take place in Boulder, Colorado in 2006.1. P. G. Debenedetti. J. Phys.: Condens. Mater. 45, R1669-1726 (2003).2. P. G. Debenedetti and H. E. Stanley. Phys. Today 56, 40-46 (2003).J. H. DymondConference Editor
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Zhao, Linhai, Rachel Marie Kwiatkowska, Jing Chai, Christie Cabral, Meixuan Chen, Karen Bowker, Caroline Coope, et al. "Pathways to optimising antibiotic use in rural China: identifying key determinants in community and clinical settings, a mixed methods study protocol." BMJ Open 9, no. 8 (August 2019): e027819. http://dx.doi.org/10.1136/bmjopen-2018-027819.
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IntroductionThis study aims to investigate patterns of antibiotic treatment-seeking, describe current levels of and drivers for antibiotic use for common infections (respiratory tract and urinary tract infections) and test the feasibility of determining the prevalence and epidemiology of antimicrobial resistance (AMR) in rural areas of Anhui province, in order to identify potential interventions to promote antibiotic stewardship and reduce the burden of AMR in China.Methods and analysisWe will conduct direct observations, structured and semistructured interviews in retail pharmacies, village clinics and township health centres to investigate treatment-seeking and antibiotic use. Clinical isolates from 1550 sputum, throat swab and urine samples taken from consenting patients at village and township health centres will be analysed to identify bacterial pathogens and ascertain antibiotic susceptibilities. Healthcare records will be surveyed for a subsample of those recruited to the study to assess their completeness and accuracy.Ethics and disseminationThe full research protocol has been reviewed and approved by the Biomedical Ethics Committee of Anhui Medical University (reference number: 20170271). Participation of patients and doctors is voluntary and written informed consent is sought from all participants. Findings from the study will be disseminated through academic routes including peer-reviewed publications and conference presentations, via tailored research summaries for health professionals, health service managers and policymakers and through an end of project impact workshop with local and regional stakeholders to identify key messages and priorities for action.
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Bwakura-Dangarembizi, Mutsa, Beatrice Amadi, Claire D. Bourke, Ruairi C. Robertson, Benjamin Mwapenya, Kanta Chandwe, Chanda Kapoma, et al. "Health Outcomes, Pathogenesis and Epidemiology of Severe Acute Malnutrition (HOPE-SAM): rationale and methods of a longitudinal observational study." BMJ Open 9, no. 1 (January 2019): e023077. http://dx.doi.org/10.1136/bmjopen-2018-023077.
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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 high risk of morbidity, mortality and relapse after discharge from hospital although long-term outcomes are not well documented. Better understanding the pathogenesis of SAM and the factors associated with poor outcomes may inform new therapeutic interventions.Methods and analysisThe Health Outcomes, Pathogenesis and Epidemiology of Severe Acute Malnutrition (HOPE-SAM) study is a longitudinal observational cohort that aims to evaluate the short-term and long-term clinical outcomes of HIV-positive and HIV-negative children with complicated SAM, and to identify the risk factors at admission and discharge from hospital that independently predict poor outcomes. Children aged 0–59 months hospitalised for SAM are being enrolled at three tertiary hospitals in Harare, Zimbabwe and Lusaka, Zambia. Longitudinal mortality, morbidity and nutritional data are being collected at admission, discharge and for 48 weeks post discharge. Nested laboratory substudies are exploring the role of enteropathy, gut microbiota, metabolomics and cellular immune function in the pathogenesis of SAM using stool, urine and blood collected from participants and from well-nourished controls.Ethics and disseminationThe study is approved by the local and international institutional review boards in the participating countries (the Joint Research Ethics Committee of the University of Zimbabwe, Medical Research Council of Zimbabwe and University of Zambia Biomedical Research Ethics Committee) and the study sponsor (Queen Mary University of London). Caregivers provide written informed consent for each participant. Findings will be disseminated through peer-reviewed journals, conference presentations and to caregivers at face-to-face meetings.
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Vogel, Nicole, Thomas Rychen, Raphael Kaelin, and Markus P. Arnold. "Patient-reported outcome measures (PROMs) following knee arthroplasty: a prospective cohort study protocol." BMJ Open 10, no. 12 (December 2020): e040811. http://dx.doi.org/10.1136/bmjopen-2020-040811.
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IntroductionTo evaluate the quality of clinical practice, patient-reported outcome measures (PROMs) are important as certain questions could only be answered by the patient himself. PROMs help to get a better understanding what is meaningful to a patient and directly affects daily functioning. To move beyond traditional measures, we are interested in what matters to patients and developed this project. The aim of this article is to provide the protocol for our study collecting PROMs in daily medical practice from patients who undergo knee arthroplasty.Methods and analysisThis study is a single-site, observational, prospective cohort study. We will recruit patients scheduled for a knee arthroplasty in our medical office, situated in a private clinic. After signed informed consent, patients complete self-reported questionnaires before the surgery, after 4 months, 1 year, 2 years, 3 years, 4 years and 5 years. We will use the following PROMs: Knee injury and Osteoarthritis Outcome Score, Forgotten Joint Score, EuroQol five dimensions and satisfaction. Additionally, the surgeon will complete the objective Knee Society Score. Administration of the questionnaires will be electronically or paper-based. We will assess differences between preoperative and postoperative data with paired t-test for continuous variables and Wilcoxon signed-rank test for categorical variables. To assess subgroup differences, we will use unpaired t-test for continuous variables and Mann-Whitney U test for categorical variables. To assess possible presence of bias, we will conduct sensitivity analyses.Ethics and disseminationThe study has been reviewed and approved by the local ethics committee in Basel, Switzerland. Written informed consent will be obtained from all patients. We will disseminate the results of the study through peer-reviewed journals, national and international conference presentations and presentations to relevant stakeholders through appropriate channels.
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Mohammad Redzuan, Saidatul Akmar, Priyasini Suntharalingam, Thenmoli Palaniyappan, Venotha Ganasan, Puteri Normalina Megat Abu Bakar, Paream Kaur, Lili Zuryani Marmuji, Subashini Ambigapathy, V. Paranthaman, and Boon How Chew. "Prevalence and risk factors of postpartum depression, general depressive symptoms, anxiety and stress (PODSAS) among mothers during their 4-week postnatal follow-up in five public health clinics in Perak: A study protocol for a cross-sectional study." BMJ Open 10, no. 6 (June 2020): e034458. http://dx.doi.org/10.1136/bmjopen-2019-034458.
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IntroductionPostpartum depression, general depressive symptoms, anxiety and stress (PODSAS) are often overlooked, and may cause morbidity to new mothers, their babies and families. This study aims to determine the point prevalence of depression (post partum and general), anxiety and stress among mothers in five public health clinics in Perak at 4 weeks postdelivery and identify their associated risk factors. Findings from this study will be used to identify the needs for early screening and detection, encourage development of interventions to reduce its occurrence and support mothers with PODSAS.Methods and analysisThis cross-sectional study will recruit 459 postpartum mothers during their 4-week postnatal follow-up in five selected public health clinics in Perak from September 2019 to May 2020. Participants will be mothers aged 18 years and above at 4 weeks postdelivery who are able to understand the English and Malay languages. Non-Malaysians and mothers with known diagnosis of psychotic disorders will be excluded from the study. Sociodemographic information and possible risk factors of the participants will be captured via a set of validated questionnaires, postpartum depression (PPD) will be measured using the Edinburgh Postpartum Depression Scale questionnaire and general depressive symptoms, anxiety and stress will be measured using the 21-item Depression, Anxiety and Stress Scale. Data analysis will be conducted using SPSS V.25.0 (IBM). Besides descriptive statistics, multivariable regression analyses will be done to identify possible risk factors and their independent associations with depression (PPD and general depressive symptoms, combined and separately), anxiety and stress.Ethics and disseminationThe study protocol was reviewed and approved by the Medical Research Ethics Committee, Ministry of Health Malaysia on 7 August 2019. Results of this study will be reported and shared with the local health stakeholders and disseminated through conference proceedings and journal publications.Registration numberThis study is registered in the Malaysian National Medical Research Register with the ID: NMRR-19-868-47647
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Drynda, Susanne, Wencke Schindler, Anna Slagman, Johannes Pollmanns, Dirk Horenkamp-Sonntag, Wiebke Schirrmeister, Ronny Otto, et al. "Evaluation of outcome relevance of quality indicators in the emergency department (ENQuIRE): study protocol for a prospective multicentre cohort study." BMJ Open 10, no. 9 (September 2020): e038776. http://dx.doi.org/10.1136/bmjopen-2020-038776.
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IntroductionQuality of emergency department (ED) care affects patient outcomes substantially. Quality indicators (QIs) for ED care are a major challenge due to the heterogeneity of patient populations, health care structures and processes in Germany. Although a number of quality measures are already in use, there is a paucity of data on the importance of these QIs on medium-term and long-term outcomes. The evaluation of outcome relevance of quality indicators in the emergency department study (ENQuIRE) aims to identify and investigate the relevance of QIs in the ED on patient outcomes in a 12-month follow-up.Methods and analysisThe study is a prospective non-interventional multicentre cohort study conducted in 15 EDs throughout Germany. Included are all patients in 2019, who were ≥18 years of age, insured at the Techniker Krankenkasse (statutory health insurance (SHI)) and gave their written informed consent to the study.The primary objective of the study is to assess the effect of selected quality measures on patient outcome. The data collected for this purpose comprise medical records from the ED treatment, discharge (claims) data from hospitalised patients, a patient questionnaire to be answered 6–8 weeks after emergency admission, and outcome measures in a 12-month follow-up obtained as claims data from the SHI.Descriptive and analytical statistics will be applied to provide summaries about the characteristics of QIs and associations between quality measures and patient outcomes.Ethics and disseminationApproval of the leading ethics committee at the Medical Faculty of the University of Magdeburg (reference number 163/18 from 19 November 2018) has been obtained and adapted by responsible local ethics committees.The findings of this work will be disseminated by publication of peer-reviewed manuscripts and presentations as conference contributions (abstracts, poster or oral presentations).Moreover, results will be discussed with clinical experts and medical associations before being proposed for implementation into the quality management of EDs.Trial registration numberGerman Clinical Trials Registry (DRKS00015203); Pre-results.
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Ekker, Merel, Mina Jacob, Myrna van Dongen, Karoliina Aarnio, Arunkar Annamalai, Antonio Arauz, Marcel Arnold, et al. "Global Outcome Assessment Life-long after stroke in young adults initiative—the GOAL initiative: study protocol and rationale of a multicentre retrospective individual patient data meta-analysis." BMJ Open 9, no. 11 (November 2019): e031144. http://dx.doi.org/10.1136/bmjopen-2019-031144.
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IntroductionWorldwide, 2 million patients aged 18–50 years suffer a stroke each year, and this number is increasing. Knowledge about global distribution of risk factors and aetiologies, and information about prognosis and optimal secondary prevention in young stroke patients are limited. This limits evidence-based treatment and hampers the provision of appropriate information regarding the causes of stroke, risk factors and prognosis of young stroke patients.Methods and analysisThe Global Outcome Assessment Life-long after stroke in young adults (GOAL) initiative aims to perform a global individual patient data meta-analysis with existing data from young stroke cohorts worldwide. All patients aged 18–50 years with ischaemic stroke or intracerebral haemorrhage will be included. Outcomes will be the distribution of stroke aetiology and (vascular) risk factors, functional outcome after stroke, risk of recurrent vascular events and death and finally the use of secondary prevention. Subgroup analyses will be made based on age, gender, aetiology, ethnicity and climate of residence.Ethics and disseminationEthical approval for the GOAL study has already been obtained from the Medical Review Ethics Committee region Arnhem-Nijmegen. Additionally and when necessary, approval will also be obtained from national or local institutional review boards in the participating centres. When needed, a standardised data transfer agreement will be provided for participating centres. We plan dissemination of our results in peer-reviewed international scientific journals and through conference presentations. We expect that the results of this unique study will lead to better understanding of worldwide differences in risk factors, causes and outcome of young stroke patients.
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Dymond, John H. "Preface." Pure and Applied Chemistry 79, no. 8 (January 1, 2007): iv. http://dx.doi.org/10.1351/pac20077908iv.
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The 19th International Conference on Chemical Thermodynamics (ICCT-19) took place as part of THERMO International 2006, together with the 16th Symposium on Thermophysical Properties and the 61st Calorimetry Conference, from 30 July to 4 August 2006 at the University of Colorado, Boulder, CO, USA. Dr. W. M. Haynes was President of the Executive Board of THERMO International 2006, and Drs. M. Frenkel, R. D. Chirico, and J. W. Magee were the organizers of ICCT. Overall, 768 speakers submitted the abstracts of their presentations, including about 30 students and 11 exhibitors, from 62 countries (235 from North America, 341 from Europe, 76 from Japan, and 33 from China). About 65 % of the participants were from academia and 15 % from industry, with 20 % from governmental and international organizations.These individual conferences have an overlap of areas of interest, but this was the first time that they have been held jointly at the same site. This provided a unique opportunity for researchers and practitioners worldwide to meet and discuss a broad range of scientific problems in the fields of thermodynamics and thermophysical properties for a wide variety of systems, with applications in chemistry and other scientific and engineering disciplines.After the official opening ceremony, there was an invited keynote presentation by Prof. W. A. Wakeham from the University of Southampton, Southampton, UK, entitled "Thermophysical property measurements: The journey from accuracy to fitness for purpose". The Rossini Award lecture was given by Prof. A. Navrotsky on "Calorimetry of nanoparticles, surfaces, interfaces, thin films, and multilayers".The ICCT program consisted of nine symposia, some of which were held jointly with the other conferences. The plenary lecturers and invited speakers in these symposia, and the titles of the plenary lectures, were as follows:Electrolyte and Non-Electrolyte Solution Thermodynamics: J. M. Prausnitz (plenary), "Some promising frontiers in the thermodynamics of protein solutions"; C. G. Panayiotou, P. R. Tremaine, and T. Kimura (invited)Ionic Liquids: K. Seddon (plenary); "The mark of an educated mind"; L. P. N. Rebelo and C. J. Peters (invited)Molecular Modelling, Including Simulation: D. Evans (plenary), "The fluctuation and non-equilibrium free energy theorems: Theory and experiment"; H. Tanaka, J. Errington, and A. Klamt (invited)Thermochemistry and Molecular Energetics: J. A. de Sousa Martinho Simões (plenary), "Energetics of free radicals: Bridges between gas-phase and solution data"; W. E. Acree, Jr. and J. S. Chickos (invited)Thermodynamics and Properties in the Biological, Medical, Pharmaceutical, Agricultural, and Food Sectors: P. L. Privalov (plenary), "Thermodynamic problems in structural molecular biology"; J. M. Sanchez-Ruiz and H. H. Klump (invited)Databases, Data Systems, Software Applications, and Correlations: M. Satyro (plenary), "Life, data and everything"; R. L. Rowley and R. Sass (invited)Phase Equilibrium, Supercritical Fluids, and Separation Technologies: S. Sandler (plenary), "Computational quantum mechanics: An under-utilized tool for applied thermodynamics"; L. F. Vega and R. P. Danner (invited)Colloid and Interface Science: L. Piculell (plenary), "Controlling structure in associating polymer-surfactant mixtures"; H. K. Yan and K. Lohner (invited)New Materials: V. K. Pecharsky (plenary), "Structure, mechanism, and thermodynamics of novel rare-earth-based inter-metallic materials"; C. Staudt-Bickel and J. Pons (invited)The plenary lectures, with the exception of the lecture by Prof. K. Seddon, are published in this issue.There were workshops on New Experimental Techniques, with Profs. C. Schick and J. P. M. Trusler as invited speakers, on Properties and Processes for a Hydrogen-Based Economy, where Prof. C. J. Peters was the invited speaker, and on Thermodynamic Frontiers and Education, with Profs. R. N. Lichtenthaler and R. Battino as invited speakers.In addition, there was a workshop on the Thermodynamic Properties of Hydration (with Prof. V. Majer as invited speaker), software demonstrations, and two afternoon poster sessions, with over 400 posters. The sessions were held in the well-appointed Stadium Club, against the beautiful backdrop of the Flatirons to the west and the plains stretching across to the east. IUPAC had donated three poster prizes, a framed certificate signed by IUPAC President Brian Henry, a copy of the IUPAC "Gold Book" and a two-year subscription to Chemistry International. These were awarded to Martinez-Herrera Melchor (Mexico), Lisa Ott (USA), and Isabel Marrucho (Spain).Doctorate awards were presented by the International Association of Chemical Thermodynamics (IACT), with sponsorship from Elsevier. The four recipients were M. Fulem (Prague, Czech Republic), Y. U. Paulechka (Minsk, Belarus), E. Asabina (Nizhni Novgorod, Russian Federation), and J. Xu (Trondheim, Norway). They each received a certificate, plus a cash prize of $500, and presented their papers at the conference.All the lectures demonstrated how chemical thermodynamics is making, and will continue to make, very significant contributions to the rapidly developing interdisciplinary fields such as the life sciences, new materials, medicine and pharmacy, new energy resources, the environment, separation technologies, agriculture, green chemistry, and so on. These are all extremely important issues for scientists worldwide, and particularly for those who are in developing or economically disadvantaged countries. The opportunity for face-to-face discussion and communication with scientists from developed countries was a great benefit, which will lead to further research and improved education.The weather was most pleasant for the conference. This, together with the attractive setting of the campus, the welcoming reception, the conference banquet at the National Center for Atmospheric Research, and the high standard of the presentations, made this a memorable conference. In addition, there was a full program of tours for accompanying persons, which included a visit to the mile-high city (Denver). Our thanks are extended to the Conference Chair and Co-chairs, and to all members of the local Organizing Committee, the members of the International Advisory Committee, and the members of the International Scientific Committee. We are most grateful to IUPAC, the International Association of Chemical Thermodynamics, the National Institute of Standards and Technology, the American Society of Mechanical Engineers, and the American Institute of Chemical Engineers, Elsevier, Honeywell, and Mettler Toledo for sponsoring THERMO International 2006.Thermodynamics will continue to be an important area of research for many years to come, with a wide range of applications from chemical engineering to the biosciences. We look forward to the presentation and discussion of the results of further advances in chemical thermodynamics at the next ICCT, which will take place in Warsaw, Poland in August 2008.John H. DymondConference Editor
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Beecham, L. "The BMA annual representative meeting Doctors oppose resiting of juniors' contracts Private hospital given kiss of life From the local medical committee conference There should be an alternative to target net remuneration Core element of general medical services must be defined GMSC will have triennial elections." BMJ 311, no. 6997 (July 8, 1995): 130. http://dx.doi.org/10.1136/bmj.311.6997.130.
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Parker, Elizabeth, Victoria Flood, Mark Halaki, Christine Wearne, Gail Anderson, Linette Gomes, Simon Clarke, et al. "Study protocol for a randomised controlled trial investigating two different refeeding formulations to improve safety and efficacy of hospital management of adolescent and young adults admitted with anorexia nervosa." BMJ Open 10, no. 10 (October 2020): e038242. http://dx.doi.org/10.1136/bmjopen-2020-038242.
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IntroductionProviding effective nutritional rehabilitation to patients hospitalised with anorexia nervosa (AN) is challenging, partly due to conservative recommendations that advocate feeding patients at low energy intakes. An ‘underfeeding syndrome’ can develop when patients are not provided with adequate nutrition during treatment, whereby malnourished patients fail to restore weight in a timely matter, and even lose weight. Of particular concern, the reintroduction of carbohydrate in a starved patient can increase the risk of developing electrolyte, metabolic and organ dysfunction. The proposed trial assesses the efficacy and safety of a lower carbohydrate enteral formula (28% carbohydrate) against a standard enteral formula (54% carbohydrate), in adolescent and young adult patients (aged 15–25 years), hospitalised with AN.Methods and analysisThe study employs a double-blind randomised controlled trial design. At admission to hospital, malnourished adolescent and young adults with AN will be randomly allocated to commence feeding on a standard enteral feeding formula (1.5 kcal/mL, 54% carbohydrate) or a lower carbohydrate isocaloric enteral feeding formula (1.5 kcal/mL, 28% carbohydrate). Assessments of nutritional intake, weight and biochemistry (phosphate, magnesium, potassium) will be conducted at baseline and during the first 3 weeks of hospital admission. The primary outcome measure will be incidence of hypophosphatemia. Secondary outcomes include weight gain, oedema, other electrolyte distortion, length of hospital admission, admission to the Intensive Care Unit (ICU) and number of days to reach medical stability, using defined parameters.Ethics and disseminationThe protocol was approved by the Western Sydney Local Health District Human Research Ethics Committee and institutional research governance approvals were granted. Written informed consent will be sought prior to study enrolment. Study findings will be widely disseminated through peer-reviewed publications and conference presentations.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617000342314); Pre-results.
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Price, Angeline, Fenella Barlow-Pay, Siobhan Duffy, Lyndsay Pearce, Arturo Vilches-Moraga, Susan Moug, Terry Quinn, et al. "Study protocol for the COPE study: COVID-19 in Older PEople: the influence of frailty and multimorbidity on survival. A multicentre, European observational study." BMJ Open 10, no. 9 (September 2020): e040569. http://dx.doi.org/10.1136/bmjopen-2020-040569.
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IntroductionThis protocol describes an observational study which set out to assess whether frailty and/or multimorbidity correlates with short-term and medium-term outcomes in patients diagnosed with COVID-19 in a European, multicentre setting.Methods and analysisOver a 3-month period we aim to recruit a minimum of 500 patients across 10 hospital sites, collecting baseline data including: patient demographics; presence of comorbidities; relevant blood tests on admission; prescription of ACE inhibitors/angiotensin receptor blockers/non-steroidal anti-inflammatory drugs/immunosuppressants; smoking status; Clinical Frailty Score (CFS); length of hospital stay; mortality and readmission. All patients receiving inpatient hospital care >18 years who receive a diagnosis of COVID-19 are eligible for inclusion. Long-term follow-up at 6 and 12 months is planned. This will assess frailty, quality of life and medical complications.Our primary analysis will be short-term and long-term mortality by CFS, adjusted for age (18–64, 65–80 and >80) and gender. We will carry out a secondary analysis of the primary outcome by including additional clinical mediators which are determined statistically important using a likelihood ratio test. All analyses will be presented as crude and adjusted HR and OR with associated 95% CIs and p values.Ethics and disseminationThis study has been registered, reviewed and approved by the following: Health Research Authority (20/HRA1898); Ethics Committee of Hospital Policlinico Modena, Italy (369/2020/OSS/AOUMO); Health and Care Research Permissions Service, Wales; and NHS Research Scotland Permissions Co-ordinating Centre, Scotland. All participating units obtained approval from their local Research and Development department consistent with the guidance from their relevant national organisation.Data will be reported as a whole cohort. This project will be submitted for presentation at a national or international surgical and geriatric conference. Manuscript(s) will be prepared following the close of the project.
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Jayamaha, Akila R., Chamilya H. Perera, Mark W. Orme, Amy V. Jones, Upendra K. D. C. Wijayasiri, Thamara D. Amarasekara, Ravini S. Karunatillake, et al. "Protocol for the cultural adaptation of pulmonary rehabilitation and subsequent testing in a randomised controlled feasibility trial for adults with chronic obstructive pulmonary disease in Sri Lanka." BMJ Open 10, no. 11 (November 2020): e041677. http://dx.doi.org/10.1136/bmjopen-2020-041677.
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IntroductionInternational guidelines recommend pulmonary rehabilitation (PR) should be offered to adults living with chronic obstructive pulmonary disease (COPD), but PR availability is limited in Sri Lanka. Culturally appropriate PR needs to be designed and implemented in Sri Lanka. The study aims to adapt PR to the Sri Lankan context and determine the feasibility of conducting a future trial of the adapted PR in Sri Lanka.Methods and analysisEligible participants will be identified and will be invited to take part in the randomised controlled feasibility trial, which will be conducted in Central Chest Clinic, Colombo, Sri Lanka. A total of 50 participants will be recruited (anticipated from April 2021) to the trial and randomised (1:1) into one of two groups; control group receiving usual care or the intervention group receiving adapted PR. The trial intervention is a Sri Lankan-specific PR programme, which will consist of 12 sessions of exercise and health education, delivered over 6 weeks. Focus groups with adults living with COPD, caregivers and nurses and in-depth interviews with doctors and physiotherapist will be conducted to inform the Sri Lankan specific PR adaptations. After completion of PR, routine measures in both groups will be assessed by a blinded assessor. The primary outcome measure is feasibility, including assessing eligibility, uptake and completion. Qualitative evaluation of the trial using focus groups with participants and in-depth interviews with PR deliverers will be conducted to further determine feasibility and acceptability of PR, as well as the ability to run a larger future trial.Ethics and disseminationEthical approval was obtained from the ethics review committee of Faculty of Medical Sciences, University of Sri Jayewardenepura, Sri Lanka and University of Leicester, UK. The results of the trial will be disseminated through patient and public involvement events, local and international conference proceedings, and peer-reviewed journals.Trial registration numberISRCTN13367735
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Inhestern, Laura, Wiebke Frerichs, Lene Marie Johannsen, and Corinna Bergelt. "Process-evaluation and outcome-evaluation of a training programme for healthcare professionals in oncology to enhance their competencies in caring for patients with minor children: a study protocol for a randomised controlled pilot study." BMJ Open 9, no. 10 (October 2019): e032778. http://dx.doi.org/10.1136/bmjopen-2019-032778.
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IntroductionPatients with cancer having minor children experience particular burden and strains. Being patient and parent at the same time is associated with specific needs of support. Therefore, the communication of child-related and family-related issues plays an important role in patient care. This study aims at testing the feasibility of a training to improve the situation of patients with cancer having minor children and their families by enhancing the competencies of healthcare professionals (HCPs, eg, physicians, nurses, psychologists) in caring for patients with cancer having minor children. Moreover, the study aims at testing the study design and outcomes of the evaluation concept and preliminary effects of the training.Methods and analysisWe will conduct a randomised controlled pilot trial with three arms (face-to-face training versus web-based training versus waitlist control group) to investigate the study aims. Primary outcome will be the competency to approach child-related and family-related topics in patients with cancer measured using comprehensive case vignettes. Secondary outcomes will be communication and attitudes regarding child-related and family-related topics and self-efficacy in clinical communication skills. Outcomes will be assessed prior to the training and after the training as well as 3 months after the training. Data will be analysed using descriptive analyses, group comparisons and linear mixed models.Ethics and disseminationThe study was approved by the Local Psychological Ethics Committee of the Center for Psychosocial Medicine of the University Medical Center Hamburg-Eppendorf (LPEK-001). At the end of the study, a web-based training and a face-to-face training intervention to enhance the competencies of HCPs in caring for patients with cancer having minor children will have been systematically developed and the study design and evaluation concept will have been evaluated. The results of the study will be disseminated through peer-reviewed journals and conference presentations.Trial registration numberDRKS00015794.
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Hancocks, S. A. "Badges of the dental profession. The Annual Conference of Local Dental Committees." British Dental Journal 167, no. 8 (October 1989): 293. http://dx.doi.org/10.1038/sj.bdj.4807004.
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Pallares, Christian, and María Virginia Villegas Botero. "Implementation of an Antimicrobial Stewardship Program in Five Colombian Hospitals in 2018." Infection Control & Hospital Epidemiology 41, S1 (October 2020): s273. http://dx.doi.org/10.1017/ice.2020.842.
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Background: More than 50% of antibiotics used in hospitals are unnecessary or inappropriate. The antimicrobial stewardship programs (ASPs) are coordinated efforts to promote the rational and effective use of antibiotics including appropriate selection, dosage, administration, and duration of therapy. When an ASP integrates infection control strategies, it is possible to decrease the transmission of multidrug-resistant pathogens. Methods: In 2018, 5 Colombian hospitals were selected to implement an ASP. Private and public hospitals from different cities were included in the study, ranging from 200 to 700 beds. Our team, consisting of an infectious disease and hospital epidemiologist, visited each hospital to establish the baseline of their ASP program, to define the ASP outcomes according to each hospital’s needs, and to set goals for ASP outcomes in the following 6–12 months. Follow-up was scheduled every 2 months through Skype video conference. The baseline diagnosis or preintervention evaluation was done using a tool adapted from previous reports (ie, international consensus and The Joint Commission international standards). Documentation related to ASPs, such as microbiological profiles, antimicrobial guidelines (AMG) and indicators for the adherence to them as well as antimicrobial resistance (AMR) prevention through protocols, were written and/or updated. Prevention and infection control requirements and protocols were also updated, and cleaning and antiseptic policies were created. Training in rational use of antibiotic, infection control and prevention, and cleaning and disinfection were carried out with the healthcare workers in each institution. Results: Before the intervention, the development of the ASP according to the tool was 27% (range, 5%–47%). The lowest institutional scores were the item related to ASP feedback and reports (11% on average), followed by education and training (14%), defined ASP responsibilities (23%), ASP function according to priorities (26%), and AMR surveillance (27%). After the intervention, the ASP development increased to 57% (range, 39%–81%) in the hospitals. The highest scores achieved were for education and training (90%), surveillance (75%), and the activities of the infection control committee (70%). The items that made the greatest contribution to ASP development were the individual antibiogram, including the bacteria resistance profile, and the development of the AMG based on the local epidemiology in each hospital. Conclusions: The implementation of an ASP should include training and education as well as defining outcomes according to the hospital’s needs. Once the strategy is implemented, follow-up is key to achieving the goals.Funding: NoneDisclosures: None
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Beecham, L. "From the local medical committee conference Reaccreditation must take a lower priority Falling recruitment and morale must be addressed Conference censures GMSC over generic prescribing GPs doubt independence of review body Complaints procedure should be more flexible Home visits are anachronistic Registrars' continued unease with summative assessment GPs should not charge for travel vaccinations." BMJ 311, no. 6996 (July 1, 1995): 63. http://dx.doi.org/10.1136/bmj.311.6996.63.
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Beecham, L. "From the junior staffs conference Do SHOs have a future? The English clause must be promoted The government should act on the loss of doctors The conference .. From the local medical committee conference Out of hours must be priced separately Conference endorses new GMSC election process Doctors want to be able to complain against patients Community care is putting a burden on GPs There must be more emergency beds Alternative models of commissioning must be resourced GPs should be warned about violent patients GPs question review body's independence The conference.." BMJ 312, no. 7046 (June 22, 1996): 1612. http://dx.doi.org/10.1136/bmj.312.7046.1612.
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Collins, Katharine A., Alphonse Ouedraogo, Wamdaogo Moussa Guelbeogo, Shehu S. Awandu, Will Stone, Issiaka Soulama, Maurice S. Ouattara, et al. "Investigating the impact of enhanced community case management and monthly screening and treatment on the transmissibility of malaria infections in Burkina Faso: study protocol for a cluster-randomised trial." BMJ Open 9, no. 9 (September 2019): e030598. http://dx.doi.org/10.1136/bmjopen-2019-030598.
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IntroductionA large proportion of malaria-infected individuals in endemic areas do not experience symptoms that prompt treatment-seeking. These asymptomatically infected individuals may retain their infections for many months during which sexual-stage parasites (gametocytes) are produced that may be transmissible to mosquitoes. Reductions in malaria transmission could be achieved by detecting and treating these infections early. This study assesses the impact of enhanced community case management (CCM) and monthly screening and treatment (MSAT) on the prevalence and transmissibility of malaria infections.Methods and analysisThis cluster-randomised trial will take place in Sapone, an area of intense, highly seasonal malaria in Burkina Faso. In total, 180 compounds will be randomised to one of three interventions: arm 1 - current standard of care with passively monitored malaria infections; arm 2 - standard of care plus enhanced CCM, comprising active weekly screening for fever, and detection and treatment of infections in fever positive individuals using conventional rapid diagnostic tests (RDTs); or arm 3 - standard of care and enhanced CCM, plus MSAT using RDTs. The study will be conducted over approximately 18 months covering two high-transmission seasons and the intervening dry season. The recruitment strategy aims to ensure that overall transmission and force of infection is not affected so we are able to continuously evaluate the impact of interventions in the context of ongoing intense malaria transmission. The main objectives of the study are to determine the impact of enhanced CCM and MSAT on the prevalence and density of parasitaemia and gametocytaemia and the transmissibility of infections. This will be achieved by molecular detection of infections in all study participants during start and end season cross-sectional surveys and routine sampling of malaria-positive individuals to assess their infectiousness to mosquitoes.Ethics and disseminationThe study has been reviewed and approved by the London School of Hygiene and Tropical Medicine (LSHTM) (Review number: 14724) and The Centre National de Recherche et de Formation sur le Paludisme institutional review board (IRB) (Deliberation N° 2018/000002/MS/SG/CNRFP/CIB) and Burkina Faso national medical ethics committees (Deliberation N° 2018-01-010).Findings of the study will be shared with the community via local opinion leaders and community meetings. Results may also be shared through conferences, seminars, reports, theses and peer-reviewed publications; disease occurrence data and study outcomes will be shared with the Ministry of Health. Data will be published in an online digital repository.Trial registration numberNCT03705624.
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Hillebregt, Chantal F., Eline W. M. Scholten, Marjolijn Ketelaar, Marcel W. M. Post, and Johanna M. A. Visser-Meily. "Effects of family group conferences among high-risk patients of chronic disability and their significant others: study protocol for a multicentre controlled trial." BMJ Open 8, no. 3 (March 2018): e018883. http://dx.doi.org/10.1136/bmjopen-2017-018883.
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IntroductionMany patients and family members experience a large gap between the protected environment during inpatient medical rehabilitation and life in the community after discharge. They feel insufficiently prepared to cope with the consequences of their disability in daily life. This study protocol describes the design measuring the effectiveness and implementation of family group conferences on the empowerment of patients with a high risk of chronic disability and their significant others.Methods and analysisA multicentre controlled trial will be carried out in 12 rehabilitation centres in the Netherlands. A total of 328 clinically admitted patients will participate (≥18 years, diagnosed with acquired brain injury, spinal cord injury or leg amputation), and their significant others will be included. During three family group conferences, supported by the social worker, the patient, significant other and their social network will be stimulated in collaboration, to set up participation goals, determine the needed help and make a concrete action plan. Self-reported questionnaires will be collected at baseline, clinical discharge, and 3 months and 6 months following clinical discharge. Empowerment as the primary outcome is operationalised as self-efficacy and participation. Secondary outcome measures are psychological (eg, coping, neuroticism) and environmental (eg, family functioning, social support) factors. This is the first controlled trial evaluating the effectiveness of family group conferences in rehabilitation medicine among adult patients and their significant others, providing us with knowledge in improving rehabilitation care.Ethics and disseminationThis study has been approved by the Medical Ethics Committee of the University Medical Center Utrecht (number 15–617/C). The results will be published in peer-reviewed journals and presented in local, national and international conferences.Trial registration numberNTR5742; Pre-results.
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Gorsky, Martin. "The Gloucestershire Extension of Medical Services Scheme: An Experiment in the Integration of Health Services in Britain before the NHS." Medical History 50, no. 4 (October 1, 2006): 491–512. http://dx.doi.org/10.1017/s0025727300010309.
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One of the animating beliefs of British health service reformers in the first half of the twentieth century was that delivery would improve if greater co-ordination was imposed over disparate providers. The fundamental divisions were between the voluntary, public and private sectors. Voluntary provision predominantly meant acute care hospitals, but also included a range of other therapeutic and clinical services. The public sector delivered general practitioner (GP) services to insured workers through the state national health insurance (NHI) scheme, while the remit of local government covered environmental health, isolation and general hospitals and a wide range of personal services addressing tuberculosis, venereal diseases, mental illness, and maternity and child welfare. Finally, the private sector provided nursing homes and GP attendance at commercial rates. Within each area there were tendencies towards independent rather than co-operative working. Voluntary hospitals often lacked any mechanism for conferring with neighbouring institutions and the competitive logic of fund-raising enforced an individualistic ethic. In the public sector health responsibilities were dispersed across various agencies: local authority health committees, advised by the county or borough Medical Officer of Health (MOH), oversaw sanitation, hospitals and personal health services; education committees were responsible for the School Medical Service (SMS), whose remit was the compulsory medical inspection and treatment of elementary schoolchildren; the Poor Law provided institutional care either in workhouses or separate infirmaries, although after the 1929 Local Government Act the boards of guardians were broken up; their powers were then transferred to the public assistance committees of local authorities, however these remained distinct from health committees. GP services accessed through the state NHI system were overseen by local insurance committees separate from local government. Private practice co-existed with NHI and doctors tended to prioritize fee-paying rather than panel patients.
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Mino, Jean-Christophe. "Hospital Ethics Committees in Paris." Cambridge Quarterly of Healthcare Ethics 9, no. 3 (July 2000): 424–28. http://dx.doi.org/10.1017/s0963180100003170.
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Even if the term bioethics is used all over the world, its meanings are multiple and different, especially between American and European countries, depending on local cultural and medical contexts. These differences concern the issues discussed or the institutional form bioethics takes. In France, bioethics was used from the end of the 1970s and focused on research ethics and issues at the beginning of life. At the national level, a permanent commission, the “national consultative ethics committee on life sciences and health” (Comité Consultatif National d'Ethique, CCNE) was created by President François Mitterrand in 1983. Its recommendations dealt essentially with procreative medicine and biomedical research ethics.
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Sabatino, Brent, Reuben Salinas, Loc H. Lam, and Leopoldo C. Cancio. "824 Burn Strong Initiative: A Burn Center’s Response to Fire Department Needs." Journal of Burn Care & Research 41, Supplement_1 (March 2020): S251. http://dx.doi.org/10.1093/jbcr/iraa024.400.
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Abstract Introduction The purpose of this project is to enhance burn education, both inside and outside the Burn Center. The project was motivated by a perceived gap in burn education for the city’s Fire Department (FD). Here, we describe the progress made in closing this gap. In a combined effort between both institutions, a partnership has been developed to help new paramedic firefighters and existing firefighters understand the burn-care process and improve patient outcomes. Since its inception in August 2018, the Burn Strong Initiative has had 3 focuses: 1) train burn center personnel; 2) train FD personnel; and 3) conduct further community outreach. Methods Aim 1 – Burn Center Staff Training. To improve our clinical skills and to enhance our ability to serve as educators in the community, we committed to achieving Advanced Burn Life Support (ABLS) certification for > 90% of our Burn Center clinical staff. Aim 2 – Firefighter Training. The city requested that we develop and implement a new 2-hour Thermal Injury Update class delivered weekly for a total of 36 weeks to EMTs and paramedics, starting January 2018 thru December 2019. Aim 3 – FD Medical Staff Training. The city requested that the Burn Center provide an ABLS course for the FD’s physician staff. Results Aim 1 – To date, we trained 104 Burn Center staff in ABLS, 22 of whom became ABLS instructors. Aim 2 – Burn Strong has completed 28 Thermal Injury Update classes for 615 FD paramedics. There are 10 classes remaining through the end of this year. Total paramedics to be trained is expected to be > 1000. The paramedics receiving 2 CEUs for this course. Aim 3 – We trained 19 FD physicians in ABLS, 4 of whom have become ABLS instructors. We trained an additional 15 personnel at our Regional Advisory Council conference. Conclusions This training effort has better prepared us to treat these complex patients, and has become the initial point of entry into an immersive partnership between the burn center and the city FD. Training firefighters requires ongoing commitment and an understanding of the pre-hospital environment. We plan to continue and expand our partnership with the city and the region to improve burn care. Applicability of Research to Practice This project demonstrates how burn center personnel, through training tailored to local requirements, can collaborate with their FD, improve burn care, and build strong partnerships.
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Colombo, Christopher J., Stephanie Baer, Lindsay Blake, Wendy B. Bollag, Rhonda Colombo, Matthew Diamond, Varghese George, et al. "A departmental initiative for clinical and translational research." Journal of Investigative Medicine 64, no. 5 (April 12, 2016): 1001–5. http://dx.doi.org/10.1136/jim-2016-000089.
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To encourage departmental research activities, the Department of Medicine of the Medical College of Georgia (MCG) introduced an internally funded Translational Research Program (TRP) in 2014. Patterned after the Vanderbilt Institute for Clinical and Translational Research, the program offers research studios for project guidance, research mentoring and the availability of limited financial support through research vouchers. Additional academic services include abstract reviewing, conducting research conferences, organizing departmental research programs for students, and offering courses in biostatistics. During the first 15 months of its existence, the TRP working group addressed 132 distinct activities. Research mentoring, publications, and the conduct of research studios or voucher approvals encompassed 49% of working group activities. Other academic services constituted the remaining 51%. Twenty-four per cent of TRP committee activities involved research mentoring of 32 investigators (25% faculty and 75% trainees). Mentored projects generated 17 abstracts, 2 manuscripts and $87,000 in funds. The TRP conducted 13 research studios; trainees presented 54%. The TRP reviewed 36 abstracts for local and state organizations. Monthly research conferences and statistical courses were conducted and well attended. Our experience thus far indicates that a departmental TRP may serve to facilitate the growth of patient-oriented research with minimal financial support. It requires active engagement of volunteer faculty and departmental leadership willing to balance research with the other demands of the academic mission.
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Bucci, Kathryn K., and Keith A. Frey. "A Description of a Pharmacotherapy Curriculum in a University-Based Family Medicine Program." Annals of Pharmacotherapy 26, no. 7-8 (July 1992): 991–94. http://dx.doi.org/10.1177/106002809202600725.
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OBJECTIVE: To describe the methods by which a family medicine residency program implements a pharmacotherapy curriculum. The goal of the curriculum is to teach family medicine residents the principles of rational drug therapy. SETTING: A university-based family medicine residency program. TEACHING STRATEGIES: Specific learning objectives are discussed and the following teaching strategies are expanded upon: (1) monthly noon conferences; (2) a printed formulary and pharmacotherapy handbook; (3) a pharmacy and therapeutics committee; (4) policy statements for drug representatives and use of samples; (5) an on-site pharmacy; (6) quarterly newsletter, and (7) inpatient consultation coverage. PHARMACIST ROLE: The role and responsibilities of the pharmacy faculty and pharmacist(s) who implement this curriculum and the methods used to evaluate its effectiveness are also described. The availability and funding of the pharmacy faculty member can sometimes be arranged with local schools of pharmacy seeking clerkship sites. Interaction with pharmacy students also serves to enhance the educational experience of the family medicine residents. CONCLUSIONS: The family medicine program implements a comprehensive curriculum designed to teach family medicine residents the principles of rational drug therapy. The curriculum may be expanded upon as necessary, or, if the entire program is not feasible, certain elements may be extracted and applied in other institutions.
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Hedgecoe, Adam. "“A Form of Practical Machinery”: The Origins of Research Ethics Committees in the UK, 1967–1972." Medical History 53, no. 3 (July 2009): 331–50. http://dx.doi.org/10.1017/s0025727300000211.
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Given the centrality of ethics review by independent committees (called Research Ethics Committees, or RECs, in the UK) to modern biomedical research, and the ubiquity of complaints about such review on the part of researchers, it is curious that little attention has been paid to these organizations by medical historians in contrast to the work done on the role of institutions such as the British Medical Association (BMA) and the General Medical Council (GMC) in the development of medical professional ethics, and the general evolution of medical professionals' ethical values. Thus while some work has explored the origins of modern medical ethics teaching in the UK and the parallel development of academic bioethics, there has been very little consideration of how Research Ethics Committees specifically were set up and evolved in the late 1960s and early 1970s. Although some scholars have discussed the development of the British REC system, this work tends to provide little beyond an outline of major events. These might include a report from the Royal College of Physicians (RCP) in 1967, the Department of Health's ‘Red Book’ of 1991 outlining the responsibilities of Local Research Ethics Committees (LRECs) and, more recently, the introduction of multicentre RECs (MRECs) in 1997.
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Rashid, Aneesa Abdul, Sazlina Shariff Ghazali, Iliana Mohamad, Maliza Mawardi, Dalila Roslan, and Husna Musa. "Quasi-experimental study on the effectiveness of a house officer preparatory course for medical graduates on self-perceived confidence and readiness: a study protocol." BMJ Open 9, no. 8 (August 2019): e024488. http://dx.doi.org/10.1136/bmjopen-2018-024488.
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IntroductionBeing a house officer (HO) is said to be associated with high levels of stress, leading to mental health problems and sometimes to quitting the medical profession altogether. In Malaysia, the number of HOs completing training on time is slowly declining, with increasing annual dropout rates. Feeling incompetent is one of the contributors towards this growing problem. This study aimed to evaluate the effectiveness of a 3-day pre-HO intervention module in addressing participants’ confidence, readiness and psychological well-being in preparation for their HO training.Methods and analysisThe pre-HO intervention is the ‘Medicorp’ module that includes clerkship, experience sharing, hands-on skills training, common clinical cases and introduction of the local healthcare system. This is a pre-post quasi-experimental study lasting 1 year, with three assessment time points—at pretraining, immediately after training and 1 month into the participants’ HO-ship. The study is currently ongoing and involves 208 participants who attended the course in Malaysia. Participants with known psychiatric illness, working HOs and medical students are excluded. A pretested, self-administered questionnaire that includes baseline sociodemography, adaptation of the International Medical University (IMU) Student Competency Survey and the Depression Anxiety Stress Scale has been adopted, and 1 month follow-up will be conducted by telephone. Data will be analysed using SPSS V.24. The primary outcome is change in confidence level, while the secondary outcomes are changes in the readiness and psychological well-being of the participants.Ethics and disseminationThis study protocol has received ethics approval from Ethics Committee for Research Involving Human Subjects Universiti Putra Malaysia and the National Medical Research Registry Malaysia. Written informed consent has been obtained from each participant. Results will be disseminated through journals and conferences, especially those involved in medical education specifically looking into the training of medical doctors.Trial registration numberNCT03510195.
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Khan, Zohaib, Rumana Huque, Aziz Sheikh, Anne Readshaw, Jappe Eckhardt, Cath Jackson, Mona Kanaan, et al. "Compliance of smokeless tobacco supply chain actors and products with tobacco control laws in Bangladesh, India and Pakistan: protocol for a multicentre sequential mixed-methods study." BMJ Open 10, no. 6 (June 2020): e036468. http://dx.doi.org/10.1136/bmjopen-2019-036468.
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IntroductionSouth Asia is home to more than 300 million smokeless tobacco (ST) users. Bangladesh, India and Pakistan as signatories to the Framework Convention for Tobacco Control (FCTC) have developed policies aimed at curbing the use of tobacco. The objective of this study is to assess the compliance of ST point-of-sale (POS) vendors and the supply chain with the articles of the FCTC and specifically with national tobacco control laws. We also aim to assess disparities in compliance with tobacco control laws between ST and smoked tobacco products.Methods and analysisThe study will be carried out at two sites each in Bangladesh, India and Pakistan. We will conduct a sequential mixed-methods study with five components: (1) mapping of ST POS, (2) analyses of ST samples packaging, (3) observation, (4) survey interviews of POS and (5) in-depth interviews with wholesale dealers/suppliers/manufacturers of ST. We aim to conduct at least 300 POS survey interviews and observations, and 6–10 in-depth interviews in each of the three countries. Data collection will be done by trained data collectors. The main statistical analysis will report the frequencies and proportions of shops that comply with the FCTC and local tobacco control policies, and provide a 95% CI of these estimates. The qualitative in-depth interview data will be analysed using the framework approach. The findings will be connected, each component informing the focus and/or design of the next component.Ethics and disseminationEthical approvals for the study have been received from the Health Sciences Research Governance Committee at the University of York, UK. In-country approvals were taken from the National Bioethics Committee in Pakistan, the Bangladesh Medical Research Council and the Indian Medical Research Council. Our results will be disseminated via scientific conferences, peer-reviewed research publications and press releases.
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Veneva, Elitsa, Radka Cholakova, Ralitsa Raycheva, and Ani Belcheva. "Efficacy of vibrotactile device DentalVibe in reducing injection pain and anxiety during local anaesthesia in paediatric dental patients: a study protocol for a randomised controlled clinical trial." BMJ Open 9, no. 7 (July 2019): e029460. http://dx.doi.org/10.1136/bmjopen-2019-029460.
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IntroductionA current non-pharmacological mean for attaining painless local anaesthesia (LA) is presented by vibrotactile devices. Their concept is to reduce injection pain due to distraction by applying physical stimuli which interfere with pain signals. The aim of this study is to determine the efficacy of the DentalVibe (DV) device in reducing pain and anxiety associated with LA in paediatric patients.Methods and analysisThe proposed study is a randomised controlled clinical trial with split-mouth design. Included are positive patients aged 8–12 years, requiring buccal infiltration for extraction of two bilateral primary maxillary molars. After dental fear measurement, eligible patients undergo two single-visit treatments with DV device allocated to either first or second LA via computer-generated randomisation sequence. Outcome measures will be self-reported pain felt during LA on Visual Analogue Scale; self-reported anxiety on Facial Image Scale; pain-related behaviour according to Faces, Legs, Activity, Cry, Consolability Scale; heart rate; patient preference to LA technique.Data will be analysed with intention-to-treat concept by Student’s t-test for paired samples, Wilcoxon signed-rank test, p<0.05. Pretest on 20 subjects resulted in n=41 patients sample size.Ethics and disseminationThis study protocol has been approved by the Committee for Scientific Research Ethics, Medical University - Plovdiv, Bulgaria (Reference number P-8604, Protocol of approval No. 6/23.11.2017) and registered on a publicly accessible database. This research received institutional funding from the Medical University - Plovdiv, Bulgaria, under project SPD-03/2017. Findings will be reported in scientific publications and at research conferences, and in project summary papers for participants.Trial registration numberNCT03445182; Pre-results.
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Zijlstra, E., S. LoFoWong, G. Hutschemaekers, and A. Lagro-Janssen. "Improving care for victims: a study protocol of the evaluation of a centre for sexual and family violence." BMJ Open 6, no. 9 (September 2016): e011545. http://dx.doi.org/10.1136/bmjopen-2016-011545.
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IntroductionWorldwide, sexual and family violence are highly prevalent problems. Victims of sexual and family violence often do not seek formal help in the acute phase. When they do seek help, they encounter a system of scattered care. For this reason, a centre for sexual and family violence was launched in Nijmegen, the Netherlands. The centre provides multidisciplinary care for victims of acute sexual and/or family violence. With the study described in this study protocol, we want to evaluate the implementation process and the reach of the Center for Sexual and Family Violence Nijmegen (CSFVN).Methods and analysisWe will conduct a mixed-methods study including quantitative and qualitative methods of data collection and analysis. Data about the implementation process will be obtained via semistructured interviews and focus group discussions. Content analysis will be done in software program Atlas.ti. Analysis of file data will be undertaken to assess the reach of the CSFVN (patient characteristics and characteristics of the care they received). The data will be analysed in SPSS.Ethics and disseminationThe Medical Ethics Committee of the Radboud University Nijmegen Medical Center approved the study protocol under file number 2012–1218. Dissemination will be done by submitting scientific articles to academic peer-reviewed journals. We will present the results at relevant international, national and local conferences and meetings. We will send press releases to relevant media. We will share the results with the network of assault centres in the Netherlands.
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Compton, Carolyn C., L. Peter Fielding, Lawrence J. Burgart, Barbara Conley, Harry S. Cooper, Stanley R. Hamilton, M. Elizabeth H. Hammond, et al. "Prognostic Factors in Colorectal Cancer." Archives of Pathology & Laboratory Medicine 124, no. 7 (June 1, 2000): 979–94. http://dx.doi.org/10.5858/2000-124-0979-pficc.
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Abstract Background.—Under the auspices of the College of American Pathologists, the current state of knowledge regarding pathologic prognostic factors (factors linked to outcome) and predictive factors (factors predicting response to therapy) in colorectal carcinoma was evaluated. A multidisciplinary group of clinical (including the disciplines of medical oncology, surgical oncology, and radiation oncology), pathologic, and statistical experts in colorectal cancer reviewed all relevant medical literature and stratified the reported prognostic factors into categories that reflected the strength of the published evidence demonstrating their prognostic value. Accordingly, the following categories of prognostic factors were defined. Category I includes factors definitively proven to be of prognostic import based on evidence from multiple statistically robust published trials and generally used in patient management. Category IIA includes factors extensively studied biologically and/or clinically and repeatedly shown to have prognostic value for outcome and/or predictive value for therapy that is of sufficient import to be included in the pathology report but that remains to be validated in statistically robust studies. Category IIB includes factors shown to be promising in multiple studies but lacking sufficient data for inclusion in category I or IIA. Category III includes factors not yet sufficiently studied to determine their prognostic value. Category IV includes factors well studied and shown to have no prognostic significance. Materials and Methods.—The medical literature was critically reviewed, and the analysis revealed specific points of variability in approach that prevented direct comparisons among published studies and compromised the quality of the collective data. Categories of variability recognized included the following: (1) methods of analysis, (2) interpretation of findings, (3) reporting of data, and (4) statistical evaluation. Additional points of variability within these categories were defined from the collective experience of the group. Reasons for the assignment of an individual prognostic factor to category I, II, III, or IV (categories defined by the level of scientific validation) were outlined with reference to the specific types of variability associated with the supportive data. For each factor and category of variability related to that factor, detailed recommendations for improvement were made. The recommendations were based on the following aims: (1) to increase the uniformity and completeness of pathologic evaluation of tumor specimens, (2) to enhance the quality of the data needed for definitive evaluation of the prognostic value of individual prognostic factors, and (3) ultimately, to improve patient care. Results and Conclusions.—Factors that were determined to merit inclusion in category I were as follows: the local extent of tumor assessed pathologically (the pT category of the TNM staging system of the American Joint Committee on Cancer and the Union Internationale Contre le Cancer [AJCC/UICC]); regional lymph node metastasis (the pN category of the TNM staging system); blood or lymphatic vessel invasion; residual tumor following surgery with curative intent (the R classification of the AJCC/UICC staging system), especially as it relates to positive surgical margins; and preoperative elevation of carcinoembryonic antigen elevation (a factor established by laboratory medicine methods rather than anatomic pathology). Factors in category IIA included the following: tumor grade, radial margin status (for resection specimens with nonperitonealized surfaces), and residual tumor in the resection specimen following neoadjuvant therapy (the ypTNM category of the TNM staging system of the AJCC/UICC). Factors in category IIB included the following: histologic type, histologic features associated with microsatellite instability (MSI) (ie, host lymphoid response to tumor and medullary or mucinous histologic type), high degree of MSI (MSI-H), loss of heterozygosity at 18q (DCC gene allelic loss), and tumor border configuration (infiltrating vs pushing border). Factors grouped in category III included the following: DNA content, all other molecular markers except loss of heterozygosity 18q/DCC and MSI-H, perineural invasion, microvessel density, tumor cell–associated proteins or carbohydrates, peritumoral fibrosis, peritumoral inflammatory response, focal neuroendocrine differentiation, nuclear organizing regions, and proliferation indices. Category IV factors included tumor size and gross tumor configuration. This report records findings and recommendations of the consensus conference group, organized according to structural guidelines defined herein.
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Knipe, Duleeka W., Piumee Bandara, Lalith Senarathna, Judi Kidger, José López-López, and Thilini Rajapakse. "Childhood adversity and deliberate self-poisoning in Sri Lanka: a protocol for a hospital-based case–control study." BMJ Open 9, no. 8 (August 2019): e027766. http://dx.doi.org/10.1136/bmjopen-2018-027766.
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IntroductionChildhood adversity (CA) has been suggested as a key risk factor for suicidal behaviour, but evidence from low/middle-income countries is lacking. In Sri Lanka, CA, in the form of child maltreatment or as a consequence of maternal separation, has been highlighted in primarily qualitative or case series work, as a potentially important determinant of suicidal behaviour. To date, there have been no quantitative studies to investigate CA as a key exposure associated with suicidal behaviour in Sri Lanka. The aim of the research is to understand the association between CA and suicidal behaviour in Sri Lanka and to identify potentially modifiable factors to reduce any observed increased risk of suicidal behaviour associated with CA.Methods and analysisThis is a hospital-based case–control study. Cases (n=200) will be drawn from individuals admitted to the medical toxicology ward of the Teaching Hospital Peradeniya, Sri Lanka, for medical management of intentional self-poisoning. Sex and age frequency-matched controls (n=200) will be recruited from either patients or accompanying visitors presenting at the outpatient department and clinic of the same hospital for conditions unrelated to the outcome of interest. Conditional logistic regression will be used to investigate the association between CA and deliberate self-poisoning and whether the association is altered by other key factors including socioeconomic status, psychiatric morbidity, current experiences of domestic violence and social support.Ethics and disseminationEthics approval has been obtained from the Ethical Review Committee of the Faculty of Medicine, University of Peradeniya, Sri Lanka. Researchers have been trained in administering the questionnaire and a participant safety and distress protocol has been designed to guide researchers in ensuring participant safety and how to deal with a distressed participant. Results will be disseminated in local policy fora and peer-reviewed articles, local media, and national and international conferences.
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Roth, Susanne, Christoph Springfeld, Markus K. Diener, Christine Tjaden, Phillip Knebel, Ulla Klaiber, Christoph W. Michalski, et al. "Protocol of a prospective, monocentric phase I/II feasibility study investigating the safety of multimodality treatment with a combination of intraoperative chemotherapy and surgical resection in locally confined or borderline resectable pancreatic cancer: the combiCaRe study." BMJ Open 9, no. 8 (August 2019): e028696. http://dx.doi.org/10.1136/bmjopen-2018-028696.
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IntroductionPancreatic cancer is a devastating disease with an exceptionally poor prognosis. Complete resection of the primary tumour followed by adjuvant chemotherapy is the current standard treatment for patients with resectable disease and the only curative treatment option. However, long-term survival remains rare. Tumour cell dissemination due to manipulation during surgery may increase the rate of future metastases and local recurrence, and perioperative chemotherapy might diminish local, distant and circulating minimal residual disease. Yet, safety and feasibility of systemic chemotherapeutic treatments during pancreatic cancer resection have to be evaluated in a first instance.Methods and analysisThis is a prospective, single-centre phase I/II feasibility study to investigate the safety and tolerability of a combination of intraoperative chemotherapy and surgical resection in pancreatic cancer. Forty patients with locally confined or borderline resectable pancreatic cancer, meeting all proposed criteria will be included. Participants will receive 400 mg/m2 calcium folinate over 2 hours and 2000 mg/m2 5-fluorouracil over 48 hours, started on the day before pancreatic surgery and thus continuing during surgery. Participants will be followed until 60 days after surgery. The primary endpoint is the 30-day overall complication rate according to the Clavien-Dindo classification. Secondary endpoints comprise toxicity and treatment associated complications. Patients receiving perioperative chemotherapy will be compared with a propensity score matched contemporary control group of 70 patients with pancreatic cancer receiving the standard treatment. This trial also contains an ancillary translational study to analyse disseminated tumour cells and effects of pharmacological interventions in pancreatic cancer.Ethics and disseminationCombiCaRe has been approved by the German Federal Institute for Drugs and Medical Devices (reference number 4042787) and the Medical Ethics Committee of Heidelberg University (reference number AFmo-269/2018). The results of this trial will be presented at national and international conferences and published in peer-reviewed journals.Trial registration numberGerman Clinical Trials Register (DRKS00015766).
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Edwards, Darren J., and Andrew H. Kemp. "A novel ACT-based video game to support mental health through embedded learning: a mixed-methods feasibility study protocol." BMJ Open 10, no. 11 (November 2020): e041667. http://dx.doi.org/10.1136/bmjopen-2020-041667.
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IntroductionIn recent years, serious video games have been used to promote emotional regulation in individuals with mental health issues. Although these therapeutic strategies are innovative, they are limited with respect to scope of treatment, often focusing on specific cognitive skills, to help remediate a specific mental health disorder.ObjectiveHere, we propose a protocol for assessing the feasibility of a novel acceptance and commitment therapy (ACT)-based video game for young adults.Methods and analysisThe Medical Research Council (MRC) framework will be used for developing a complex intervention to design and test the feasibility of an ACT-based video game intervention using a mixed-methods approach involving qualitative and quantitative data. The primary outcomes will include feasibility testing of recruitment processes and the acceptability of the intervention through qualitative interviews, attendance and rates of attrition. Secondary outcomes will involve a series of quantitative questionnaires to obtain effect sizes for power analysis, allowing for the ideal sample size for an appropriately powered, randomised controlled trial to be determined.Ethics and disseminationThis study has been approved by the Psychology Department Research Ethics Committee (2020-4929-3923) at Swansea University in the UK. Dissemination activities will involve publications in peer-reviewed journals, presentations at local and national conferences and promotion through social media.Trial registration numberNCT04566042.
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Zhu, Zhaohua, Weiyu Han, Ming Lu, Jianhao Lin, Zongsheng Yin, Xifu Shang, Xisheng Weng, et al. "Effects of infrapatellar fat pad preservation versus resection on clinical outcomes after total knee arthroplasty in patients with knee osteoarthritis (IPAKA): study protocol for a multicentre, randomised, controlled clinical trial." BMJ Open 10, no. 10 (October 2020): e043088. http://dx.doi.org/10.1136/bmjopen-2020-043088.
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IntroductionThe infrapatellar fat pad (IPFP) is commonly resected during total knee arthroplasty (TKA) for better exposure. However, our previous studies have suggested that IPFP size was protective against, while IPFP signal intensity alteration was detrimental on knee symptoms and structural abnormalities. We hypothesise that an IPFP with normal qualities, rather than abnormal qualities, should be preserved during TKA. The aim of this study is to compare, over a 1-year period, the postoperative clinical outcomes of IPFP preservation versus resection after TKA in patients with normal or abnormal IPFP signal intensity alteration on MRI.Methods and analysisThree hundred and sixty people with end-stage knee osteoarthritis and on the waiting list for TKA will be recruited and identified as normal IPFP quality (signal intensity alteration score ≤1) or abnormal IPFP quality (signal intensity alteration score ≥2). Patients in each hospital will then be randomly allocated to IPFP resection group or preservation group. The primary outcomes are the summed score of self-reported Knee Injury and Osteoarthritis Outcome Score (KOOS), KOOS subscales assessing function in daily activities and function in sport and recreation. Secondary endpoints will be included: KOOS subscales (pain, symptoms and quality of life), Knee Society Score, 100 mm Visual Analogue Scale (VAS) Pain, timed up-and-go test, patellar tendon shortening, 100 mm VAS self-reported efficacy of reduced pain and increased quality of life, and Insall-Salvati index assessed on plain X-ray. Adverse events will be recorded. Intention-to-treat analyses will be used.Ethics and disseminationThe study is approved by the local Medical Ethics Committee (Zhujiang Hospital Ethics Committee, reference number 2017-GJGBK-001) and will be conducted according to the principle of the Declaration of Helsinki (64th, 2013) and the Good Clinical Practice standard, and in compliance with the Medical Research Involving Human Subjects Act . Data will be published in peer-reviewed journals and presented at conferences, both nationally and internationally.Trial registration numberThis trial was registered at Clinicaltrial.gov website on 19 October 2018 with identify number NCT03763448.
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Dutot, Camille, Grégoire Mercier, Isabelle Borget, Côme de Sauvebeuf, and Nicolas Martelli. "HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT FOR THE ADOPTION OF INNOVATIVE MEDICAL DEVICES WITHIN FRENCH HOSPITALS: OPPORTUNITIES AND CHALLENGES FOR INDUSTRY." International Journal of Technology Assessment in Health Care 33, no. 2 (2017): 297–302. http://dx.doi.org/10.1017/s0266462317000368.
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Objectives:Within French university hospitals, some internal committees are in charge of conducting hospital-based health technology assessment (Hb-HTA) to support managerial decisions regarding the adoption of innovations. For manufacturers, hospitals are usually the entry point for new and innovative medical devices, which cannot be accessed without the Hb-HTA committees' approval. Thus, the main objective of this pilot survey was to explore manufacturers’ insights into Hb-HTA processes.Methods:A two-step pilot survey was conducted in 2014. First, semi-structured phone interviews were carried out to capture manufacturers' feedback on the Hb-HTA procedure. Second, a prospective and iterative questionnaire designed to explore manufacturers’ market access strategies was administered.Results:Eight manufacturers from the medical device industry completed the retrospective phone interviews, and five of them participated in the prospective survey. According to the overall feedback, the Hb-HTA process timeline and transparency are major issues, and the expectations of internal committees, especially in terms of clinical evidence, remain difficult to understand. However, despite this and due to the complexity of reimbursement processes at the national level, manufacturers are increasingly considering hospital adoption through Hb-HTA submission as a viable market access and coverage opportunity.Conclusions:Our study reaffirms the primary role of hospitals in the diffusion of innovative medical devices. However, to ensure efficient and broad access to innovation, cooperation between local and national HTA bodies is critical and should be promoted.
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Whop, Lisa J., Tamara L. Butler, Julia M. L. Brotherton, Kate Anderson, Joan Cunningham, Allison Tong, and Gail Garvey. "Study protocol: Yarning about HPV Vaccination: a qualitative study of factors influencing HPV vaccination among Aboriginal and Torres Strait Islander adolescents in Australia." BMJ Open 11, no. 8 (August 2021): e047890. http://dx.doi.org/10.1136/bmjopen-2020-047890.
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IntroductionAboriginal and Torres Strait Islander women experience a higher burden of cervical cancer than non-Indigenous women in Australia. Cervical cancer is preventable partly through human papillomavirus (HPV) vaccination; in Australia, this is delivered through the national school-based immunisation programme. While HPV vaccination uptake is high among Australian adolescents, there remain gaps in uptake and completion among Aboriginal and Torres Strait Islander adolescents. This study aims to gain a comprehensive understanding of the barriers and facilitators to HPV vaccination uptake and completion among Aboriginal and Torres Strait Islander adolescents in Queensland, Australia.Methods and analysisThe study will be guided by an Indigenist research approach and an ecological model for health promotion. Yarning, a qualitative Indigenous research method, will be conducted in up to 10 schools. Participants will include Year 7 (12/13 years old) Aboriginal and Torres Strait Islander adolescents; parents/caregivers; and local key informants and immunisation programme partners involved in the delivery of school-based HPV immunisation programme. Participants will be recruited through school representatives and investigator networks using purposive and snowball sampling and samples of convenience. Field notes, HPV vaccination clinic observations and sequential diagramming of the HPV vaccination process will be conducted. Thematic analysis of data will be led by Aboriginal and Torres Strait Islander researchers. Synthesised sequential diagrams of the process of HPV vaccination and qualitative themes summarising key findings will be produced.Ethics and disseminationThe Aboriginal Health and Medical Research Council of New South Wales Ethics Committee (1646/20), the Australian National University Human Research Ethics Committee (HREC, 2020/478), the HREC of the Northern Territory Department of Health and Menzies School of Health Research (19-3484) and the Townsville Hospital and Health Service HREC (HREC/QTHS/73789) have approved the study. Dissemination will occur via conferences and peer-reviewed publications. Further dissemination will be determined in partnership with the Aboriginal and Torres Strait Islander Steering Committee, including Youth Representatives and Consultation Network.
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Deml, Michael J., Kristen Jafflin, Sonja Merten, Benedikt Huber, Andrea Buhl, Eleonora Frau, Valérie Mettraux, et al. "Determinants of vaccine hesitancy in Switzerland: study protocol of a mixed-methods national research programme." BMJ Open 9, no. 11 (November 2019): e032218. http://dx.doi.org/10.1136/bmjopen-2019-032218.
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IntroductionVaccine hesitancy is a complex public health issue referring to concerns about the safety, efficacy or need for vaccination. Relatively little is known about vaccine hesitancy in Switzerland. This ongoing study (2017–2021) focuses on biomedical and complementary and alternative medicine (CAM) providers and their patients since healthcare professionals play important roles in vaccination decision-making. This national research programme seeks to assess the sociocultural determinants of vaccine hesitancy regarding childhood and human papillomavirus vaccines in Switzerland. We aim to provide a detailed characterisation of vaccine hesitancy, including CAM and biomedical perspectives, patient–provider interactions, and sociocultural factors, to establish the mediating effects of vaccine hesitancy on underimmunisation, and to design an intervention to improve vaccination communication and counselling among physicians, parents and adolescents.Methods and analysisOur transdisciplinary team employs a sequential exploratory mixed-methods study design. We have established a network of more than 150 medical providers across Switzerland, including more than 40 CAM practitioners. For the qualitative component, we conduct interviews with parents, youth, and biomedical and CAM providers and observations of vaccination consultations and school vaccination information sessions. For the quantitative component, a sample of 1350 parents of young children and 722 young adults (15–26 years) and their medical providers respond to questionnaires. We measure vaccine hesitancy with the Parent Attitudes about Childhood Vaccines 15-item survey and review vaccination certificates to assess vaccination status. We administer additional questions based on findings from qualitative research, addressing communication with medical providers, vaccine information sources and perceptions of risk control vis-à-vis vaccine-preventable diseases. The questionnaires capture sociodemographics, political views, religion and spirituality, and moral foundations.Ethics and disseminationThe study was approved by the local ethics committee. The results will be published in peer-reviewed journals and disseminated to healthcare professionals, researchers and the public via conferences and public presentations.
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Parry, Amy Elizabeth, Martyn D. Kirk, David N. Durrheim, Babatunde Olowokure, and Tambri Housen. "Study protocol: building an evidence base for epidemiology emergency response, a mixed-methods study." BMJ Open 10, no. 6 (June 2020): e037326. http://dx.doi.org/10.1136/bmjopen-2020-037326.
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IntroductionDeterminants and drivers for emergencies, such as political instability, weak health systems, climate change and forcibly displaced populations, are increasing the severity, complexity and frequency of public health emergencies. As emergencies become more complex, it is increasingly important that the required skillset of the emergency response workforce is clearly defined. To enable essential epidemiological activities to be implemented and managed during an emergency, a workforce is required with the right mix of skills, knowledge, experience and local context awareness. This study aims to provide local and international responders with an opportunity to actively contribute to the development of new thinking around emergency response roles and required competencies. In this study, we will develop recommendations using a broad range of evidence to address identified lessons and challenges so that future major emergency responses are culturally and contextually appropriate, and less reliant on long-term international deployments.Method and analysisWe will conduct a mixed-methods study using an exploratory sequential study design. The integration of four data sources, including key informant interviews, a scoping literature review, survey and semistructured interviews will allow the research questions to be examined in a flexible, semistructured way, from a range of perspectives. The study is unequally weighted, with a qualitative emphasis. We will analyse all activities as individual components, and then together in an integrated analysis. Thematic analysis will be conducted in NVivo V.11 and quantitative analysis will be conducted in Stata V.15.Ethics and disseminationAll activities have been approved by the Science and Medical Delegated Ethics Review Committee at the Australian National University (protocol numbers 2018–521, 2018–641, 2019–068). Findings will be disseminated through international and local deployment partners, peer-reviewed publication, presentation at international conferences and through social media such as Twitter and Facebook.
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Martelli, Nicolas, Mathilde Billaux, Isabelle Borget, Judith Pineau, Patrice Prognon, and Helene van den Brink. "INTRODUCTION OF INNOVATIVE MEDICAL DEVICES AT FRENCH UNIVERSITY HOSPITALS: AN OVERVIEW OF HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT INITIATIVES." International Journal of Technology Assessment in Health Care 31, no. 1-2 (2015): 12–18. http://dx.doi.org/10.1017/s0266462315000057.
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Objectives: Local health technology assessment (HTA) to determine whether new health technologies should be adopted is now a common practice in many healthcare organizations worldwide. However, little is known about hospital-based HTA activities in France. The objective of this study was to explore hospital-based HTA activities in French university hospitals and to provide a picture of organizational approaches to the assessment of new and innovative medical devices.Methods: Eighteen semi-structured interviews with hospital pharmacists were conducted from October 2012 to April 2013. Six topics were discussed in depth: (i) the nature of the institution concerned; (ii) activities relating to innovative medical devices; (iii) the technology assessment and decision-making process; (iv) the methodology for technology assessment; (v) factors likely to influence decisions and (vi) suggestions for improving the current process. The interview data were coded, collated and analyzed statistically.Results: Three major types of hospital-based HTA processes were identified: medical device committees, innovation committees, and “pharmacy & management” processes. HTA units had been set up to support medical device and innovation committees for technology assessment. Slow decision making was the main limitation to both these committee-based approaches. As an alternative, “pharmacy & management” processes emerged as a means of rapidly obtaining a formal assessment.Conclusions: This study provides an overview of hospital-based HTA initiatives in France. We hope that it will help to promote hospital-based HTA activities in France and discussions about ways to improve and harmonize practices, through the development of national guidelines and/or a French mini-HTA tool, for example.