134,918 results
Search Results
52. Use of a community advisory board to build equitable algorithms for participation in clinical trials: a protocol paper for HoPeNET
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Nicole Farmer, Valerie M Mitchell, Gwenyth R Wallen, Tiffany M Powell-Wiley, Allan Johnson, Foster Osei Baah, Faustine Williams, Erika Ortiz-Chapparo, Latifa Jackson, Billy Collins, and Lennox Graham
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Computer applications to medicine. Medical informatics ,R858-859.7 - Abstract
Introduction Participation from racial and ethnic minorities in clinical trials has been burdened by issues surrounding mistrust and access to healthcare. There is emerging use of machine learning (ML) in clinical trial recruitment and evaluation. However, for individuals from groups who are recipients of societal biases, utilisation of ML can lead to the creation and use of biased algorithms. To minimise bias, the design of equitable ML tools that advance health equity could be guided by community engagement processes. The Howard University Partnership with the National Institutes of Health for Equitable Clinical Trial Participation for Racial/Ethnic Communities Underrepresented in Research (HoPeNET) seeks to create an ML-based infrastructure from community advisory board (CAB) experiences to enhance participation of African-Americans/Blacks in clinical trials.Methods and analysis This triphased cross-sectional study (24 months, n=56) will create a CAB of community members and research investigators. The three phases of the study include: (1) identification of perceived barriers/facilitators to clinical trial engagement through qualitative/quantitative methods and systems-based model building participation; (2) operation of CAB meetings and (3) development of a predictive ML tool and outcome evaluation. Identified predictors from the participant-derived systems-based map will be used for the ML tool development.Ethics and dissemination We anticipate minimum risk for participants. Institutional review board approval and informed consent has been obtained and patient confidentiality ensured.
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- 2022
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53. Use of the ONCO-TreC electronic diary compared with a standard paper diary to improve adherence to oral cancer therapy in patients with solid and haematological tumours: protocol for a randomised controlled trial
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Patrizia Serra, Carla Masini, Cecilia Anesi, Lorenzo Gios, Alessandro Passardi, Roberto Vespignani, Marco Dianti, Stefano Forti, Enrico Maria Piras, Claudio Eccher, Orazio Caffo, Annalisa Campomori, Erika Brugugnoli, Valeria Giardino, Elisabetta Petracci, Giulia Bartolini, Francesco Sullo, and Valentina Oberosler
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Medicine - Published
- 2022
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54. The 100 most-cited papers on age-related macular degeneration: a bibliographic perspective
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Andrzej Grzybowski, Chen Shtayer, Stephen G Schwartz, and Elad Moisseiev
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Ophthalmology ,RE1-994 - Abstract
The 100 most-cited papers on age-related macular degeneration (AMD) were analysed using a bibliographic study. The bibliographic databases of the Institute for Scientific Information Web of Knowledge were searched, limited to research articles published between 1965 and 2020 in peer-reviewed journals. The papers were ranked in order of number of citations since publication. Five of the top 10 (and 3 of the top 4) papers reported randomised clinical trial results for either anti-vascular endothelial growth factor agents or nutritional supplements. Four of the top 10 papers reported genotype-phenotype associations between AMD and variants in Complement Factor H. This bibliographic study provides perspective and insight into many of the most influential contributions in the understanding and management of AMD and its evolution over time.
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- 2021
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55. Does an innovative paper-based health information system (PHISICC) improve data quality and use in primary healthcare? Protocol of a multicountry, cluster randomised controlled trial in sub-Saharan African rural settings
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Tavares Madede, Jahit Sacarlal, Abdullahi Bulama Garba, Amanda Ross, Xavier Bosch-Capblanch, Angela Oyo-Ita, Richard B Yapi, Christian Auer, Mamadou Samba, Suzanne Gajewski, L Kendall Krause, Nnette Ekpenyong, Ogonna Nwankwo, Anthonia Ngozi Njepuome, Sofia Mandjate Lee, Salimata Berté, Graça Matsinhe, and David W Brown
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Medicine - Abstract
Introduction Front-line health workers in remote health facilities are the first contact of the formal health sector and are confronted with life-saving decisions. Health information systems (HIS) support the collection and use of health related data. However, HIS focus on reporting and are unfit to support decisions. Since data tools are paper-based in most primary healthcare settings, we have produced an innovative Paper-based Health Information System in Comprehensive Care (PHISICC) using a human-centred design approach. We are carrying out a cluster randomised controlled trial in three African countries to assess the effects of PHISICC compared with the current systems.Methods and analysis Study areas are in rural zones of Côte d’Ivoire, Mozambique and Nigeria. Seventy health facilities in each country have been randomly allocated to using PHISICC tools or to continuing to use the regular HIS tools. We have randomly selected households in the catchment areas of each health facility to collect outcomes’ data (household surveys have been carried out in two of the three countries and the end-line data collection is planned for mid-2021). Primary outcomes include data quality and use, coverage of health services and health workers satisfaction; secondary outcomes are additional data quality and use parameters, childhood mortality and additional health workers and clients experience with the system. Just prior to the implementation of the trial, we had to relocate the study site in Mozambique due to unforeseen logistical issues. The effects of the intervention will be estimated using regression models and accounting for clustering using random effects.Ethics and dissemination Ethics committees in Côte d’Ivoire, Mozambique and Nigeria approved the trials. We plan to disseminate our findings, data and research materials among researchers and policy-makers. We aim at having our findings included in systematic reviews on health systems interventions and future guidance development on HIS.Trial registration number PACTR201904664660639; Pre-results.
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- 2021
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56. Infrastructure and operating processes of PIONEER, the HDR-UK Data Hub in Acute Care and the workings of the Data Trust Committee: a protocol paper
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Elizabeth Sapey, Suzy Gallier, Andy Rosser, Chris James, Hina Pandya, Gillian McCarmack, Bob Ruane, Laura Forty, Benjamin L Crosby, Catherine Atkin, Ralph Evans, Kevin W Dunn, Eliot Marston, Clark Crawford, Martin Levermore, Shekha Modhwadia, John Attwood, Stephen Perks, Rima Doal, Georgios Gkoutos, Richard Dormer, and Hilary Fanning
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Computer applications to medicine. Medical informatics ,R858-859.7 - Abstract
Introduction Health Data Research UK designated seven UK-based Hubs to facilitate health data use for research. PIONEER is the Hub in Acute Care. PIONEER delivered workshops where patients/public citizens agreed key principles to guide access to unconsented, anonymised, routinely collected health data. These were used to inform the protocol.Methods This paper describes the PIONEER infrastructure and data access processes. PIONEER is a research database and analytical environment that links routinely collected health data across community, ambulance and hospital healthcare providers. PIONEER aims ultimately to improve patient health and care, by making health data discoverable and accessible for research by National Health Service, academic and commercial organisations. The PIONEER protocol incorporates principles identified in the public/patient workshops. This includes all data access requests being reviewed by the Data Trust Committee, a group of public citizens who advise on whether requests should be supported prior to licensed access.Ethics and dissemination East Midlands–Derby REC (20/EM/0158): Confidentiality Advisory Group (20/CAG/0084). www.PIONEERdatahub.co.uk
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- 2021
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57. Consistency of causal claims in observational studies: a review of papers published in a general medical journal
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Sara Schroter, Lorenzo Bertizzolo, Agnes Dechartres, Els Goetghebeur, and Camila Olarte Parra
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Medicine - Abstract
Objective To evaluate the consistency of causal statements in observational studies published in The BMJ.Design Review of observational studies published in a general medical journal.Data source Cohort and other longitudinal studies describing an exposure-outcome relationship published in The BMJ in 2018. We also had access to the submitted papers and reviewer reports.Main outcome measures Proportion of published research papers with ‘inconsistent’ use of causal language. Papers where language was consistently causal or non-causal were classified as ‘consistently causal’ or ‘consistently not causal’, respectively. For the ‘inconsistent’ papers, we then compared the published and submitted version.Results Of 151 published research papers, 60 described eligible studies. Of these 60, we classified the causal language used as ‘consistently causal’ (48%), ‘inconsistent’ (20%) and ‘consistently not causal’(32%). Eleven out of 12 (92%) of the ‘inconsistent’ papers were already inconsistent on submission. The inconsistencies found in both submitted and published versions were mainly due to mismatches between objectives and conclusions. One section might be carefully phrased in terms of association while the other presented causal language. When identifying only an association, some authors jumped to recommending acting on the findings as if motivated by the evidence presented.Conclusion Further guidance is necessary for authors on what constitutes a causal statement and how to justify or discuss assumptions involved. Based on screening these papers, we provide a list of expressions beyond the obvious ‘cause’ word which may inspire a useful more comprehensive compendium on causal language.
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- 2021
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58. Ethical issues in two parallel trials of personalised criteria for implantation of implantable cardioverter defibrillators for primary prevention: the PROFID project—a position paper
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Nikolaos Dagres, Gerhard Hindricks, Dick Willems, Marieke Bak, Hanno Tan, Georg Lindinger, Ayca Kocar, Alireza Seperhi Shamloo, and Georg Schmidt
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Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim To discuss ethical issues related to a complex study (PROFID) involving the development of a new, partly artificial intelligence-based, prediction model to enable personalised decision-making about the implantation of an implantable cardioverter defibrillator (ICD) in postmyocardial infarction patients, and a parallel non-inferiority and superiority trial to test decision-making informed by that model.Method The position expressed in this paper is based on an analysis of the PROFID trials using concepts from high-profile publications in the ethical literature.Results We identify ethical issues related to the testing of the model in the treatment setting, and to both the superiority and the non-inferiority trial. We underline the need for ethical-empirical studies about these issues, also among patients, as a parallel to the actual trials. The number of ethics committees involved is an organisational, but also an ethical challenge.Conclusion The PROFID trials, and probably other studies of similar scale and complexity, raise questions that deserve dedicated parallel ethics and social science research, but do not constitute a generic obstacle. A harmonisation procedure, comparable to the Voluntary Harmonization Procedure (VHP) for medication trials, could be needed for this type of trials.
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- 2021
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59. Feasibility study of a multicentre cluster randomised control trial to investigate the clinical and cost-effectiveness of a structured diagnostic pathway in primary care for chronic breathlessness: protocol paper
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Rachael A Evans, Sarah Edwards, Natalie Armstrong, Michael Steiner, Simon Wathall, Gillian Doe, Jill Clanchy, Stacey Chantrell, Noel Baxter, and Darren Jackson
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Medicine - Abstract
Introduction Chronic breathlessness is a common and debilitating symptom, associated with high healthcare use and reduced quality of life. Challenges and delays in diagnosis for people with chronic breathlessness frequently occur, leading to delayed access to therapies. The overarching hypothesis is a symptom-based approach to diagnosis in primary care would lead to earlier diagnosis, and therefore earlier treatment and improved longer-term outcomes including health-related quality of life. This study aims to establish the feasibility of a multicentre cluster randomised controlled trial to assess the clinical and cost-effectiveness of a structured diagnostic pathway for breathlessness in primary care.Methods and analysis Ten general practitioner (GP) practices across Leicester and Leicestershire will be cluster randomised to either a structured diagnostic pathway (intervention) or usual care. The structured diagnostic pathway includes a panel of investigations within 1 month. Usual care will proceed with patient care as per normal practice. Eligibility criteria include patients presenting with chronic breathlessness for the first time, who are over 40 years old and without a pre-existing diagnosis for their symptoms. An electronic template triggered at the point of consultation with the GP will aid opportunistic recruitment in primary care. The primary outcome for this feasibility study is recruitment rate. Secondary outcome measures, including time to diagnosis, will be collected to help inform outcomes for the future trial and to assess the impact of an earlier diagnosis. These will include symptoms, health-related quality of life, exercise capacity, measures of frailty, physical activity and healthcare utilisation. The study will include nested qualitative interviews with patients and healthcare staff to understand the feasibility outcomes, explore what is ‘usual care’ and the study experience.Ethics and dissemination The Research Ethics Committee Nottingham 1 has provided ethical approval for this research study (REC Reference: 19/EM/0201). Results from the study will be disseminated by presentations at relevant meetings and conferences including British Thoracic Society and Primary Care Respiratory Society, as well as by peer-reviewed publications and through patient presentations and newsletters to patients, where available.Trial registration number ISRCTN14483247.
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- 2021
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60. Using a journal club to navigate a maze of COVID-19 papers in a front-line hospital service.
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Wenke R, Stehlik P, Gerrard J, Mickan S, and Henry D
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- Humans, Hospitals, COVID-19
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Competing Interests: Competing interests: None declared.
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- 2023
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61. Diagnosis, prevention and treatment of common shoulder injuries in sport: grading the evidence - a statement paper commissioned by the Danish Society of Sports Physical Therapy (DSSF).
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Liaghat B, Pedersen JR, Husted RS, Pedersen LL, Thorborg K, and Juhl CB
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- Humans, Exercise Therapy methods, Shoulder Pain therapy, Denmark, Sports, Shoulder Injuries diagnosis, Shoulder Injuries prevention & control
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This statement paper summarises and appraises the evidence on diagnosis, prevention, and treatment of common shoulder injuries in sports. We systematically searched Medline and Embase. The Grading of Recommendations Assessment, Development and Evaluation tool was applied to evaluate the overall quality of evidence.For diagnosis, we included 19 clinical tests from mixed populations. Tests for anterior instability, biceps-labrum complex injuries and full subscapularis rupture had high diagnostic accuracy (low to moderate quality of evidence).For prevention, the Oslo Sports Trauma Research Center, the Shoulder Control, the FIFA 11+ shoulder injury prevention programmes, and a baseball-specific programme (range of motion, stretching, dynamic stability and strengthening exercises) showed moderate to large effect size in reducing the risk of shoulder injury compared with no intervention (very low to moderate quality of evidence).For treatment, a rehabilitation programme including stretching, ice packs, electrotherapy and compression, and strengthening exercises showed a large effect size in reducing pain and disability compared with no intervention in athletes with subacromial impingement syndrome (very low to moderate quality of evidence). For the treatment of supraspinatus tendinopathy, hyperthermia treatment (heating the skin to 38°C-40°C) resulted in large effect size in reducing pain and disability compared with ultrasound or pendular swinging and stretching exercises (moderate quality of evidence). Strengthening exercise alone or in combination with stretching exercises promoted a large effect in reducing shoulder pain (cohort studies, no comparators) (very low quality of evidence). The quality of evidence for most estimates was low to moderate, indicating that future high-quality research may alter our recommendations for clinical practice., Competing Interests: Competing interests: KT is Deputy Editor in BJSM. KT and JRP have received grants from the Danish Society of Sports Physical Therapy unrelated to the present study., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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62. Hormone replacement therapy and cancer survival: a longitudinal cohort study: protocol paper
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Carol Coupland, Julia Hippisley-Cox, Sharon Dixon, Pui San Tan, Ashley Kieran Clift, Tom Alan Ranger, Judith Burchardt, Winnie Xue Mei, and Christopher Robert Cardwell
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Medicine - Abstract
Introduction Hormone replacement therapy (HRT) can help women experiencing menopausal symptoms, but usage has declined due to uncertainty around risks of cancer and some cardiovascular diseases (CVD). Moreover, improved cancer survival rates mean that more women who survive cancer go on to experience menopausal symptoms. Understanding these relationships is important so that women and their clinicians can make informed decisions around the risks and benefits of HRT. This study’s primary aim is to determine the association between HRT use after cancer diagnosis and the risk of cancer-specific mortality. The secondary aims are to investigate the risks of HRT on subsequent cancer, all-cause mortality and CVD.Methods and analysis We will conduct a population-based longitudinal cohort study of 18–79 year-old women diagnosed with cancer between 1998 and 2020, using the QResearch database. The main exposure is HRT use, categorised based on compound, dose and route of administration, and modelled as a time-varying covariate. Analysis of HRT use precancer and postcancer diagnosis will be conducted separately. The primary outcome is cancer-specific mortality, which will be stratified by cancer site. Secondary outcomes include subsequent cancer diagnosis, CVD (including venous thrombo-embolism) and all-cause mortality. Adjustment will be made for key confounders such as age, body mass index, ethnicity, deprivation index, comorbidities, and cancer grade, stage and treatment. Statistical analysis will include descriptive statistics and Cox proportional hazards models to calculate HRs and 95% CIs.Ethics and dissemination Ethical approval for this project was obtained from the QResearch Scientific Committee (Ref: OX24, project title ‘Use of hormone replacement therapy and survival from cancer’). This project has been, and will continue to be, supported by patient and public involvement panels. We intend to the submit the findings for peer-reviewed publication in an academic journal and disseminate them to the public through Cancer Research UK.
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- 2021
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63. Implementing health communication tools at scale: mobile audio messaging and paper-based job aids for front-line workers providing community health education to mothers in Bihar, India
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Niranjan Saggurti, Dilys Walker, Laili Irani, Kala Mehta, Hina Raheel, Sridhar Srikantiah, Indrajit Chaudhuri, Evan Borkum, Tanmay Mahapatra, Yingjie Weng, Usha Kiran Tarigopula, Debarshi Bhattacharya, Yamini Atmavilas, Wolfgang Munar, Anu Rangarajan, Gary L Darmstadt, Priya Nanda, Hemant Shah, Jess Wilhelm, Kala M Mehta, Safa Abdalla, Suneeta Krishnan, Victoria Ward, Janine Schooley, Sara Chamberlain, Priyanka Dutt, Anna Godfrey, Radharani Mitra, Padmapriya Sastry, Melissa Shannon, Jason Bentley, Gary L Darmstadt, MD, Suzan L. Carmichael, Andreea Creanga, Radhirani Mitra, and Kevin Pepper
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Medicine (General) ,R5-920 ,Infectious and parasitic diseases ,RC109-216 - Published
- 2021
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64. Ageing and heterogeneity regarding autism spectrum conditions: a protocol paper of an accelerated longitudinal study
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Annabeth P Groenman, Hilde M Geurts, Joost A Agelink van Rentergem, Tulsi Radhoe, Carolien Torenvliet, and Wikke J Van der Putten
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Medicine - Abstract
Introduction Autism spectrum conditions (ASC) develop early in life and are thought to last a lifetime. However, ASC research has two major knowledge gaps that hinder progression in understanding the concept of ASC and in providing proper support for autistic adults: (1) the majority of knowledge about ASC mainly stems from childhood studies so little is known about older autistic adults and (2) while it is broadly recognised that ASC is a heterogeneous condition, we do not yet understand the differences in trajectories leading to their future outcome. We aim to fill both knowledge gaps.Methods and analysis A multistage overlapping cohort design assessing (cognitive) ageing in ASC is designed to obtain an accelerated longitudinal data set. Data, including a multitude of questionnaires, diagnostics and cognitive tests, are collected over four waves within a 10-year time frame. This will provide information regarding actual changes in quality of life, co-occurring health conditions and cognition as well as the possibility to test external validity and temporal stability in newly formed behavioural subtypes. Participants consist of three groups of adults aged 20–90 years: (1) with a clinical diagnosis of ASC, (2) with a clinical diagnosis of attention deficit hyperactivity disorder (ADHD) but no ASC, (3) no ASC/ADHD (ie, comparison group). The sample size differs between waves and instruments. Detailed analysis plans will be preregistered in AsPredicted or at the Open Science Framework.Ethics and dissemination Ethical approval for this study was obtained from the ethical review board of the Department of Psychology of the University of Amsterdam (wave 1 2011-PN-1952 and 2013-PN-2668, wave 2 2015-BC-4270, waves 3 and 4 2018-BC-9285). In line with the funding policies of the grant organisation funding this study, future papers will be published open access.
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- 2021
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65. Response to the white paper on MHA reform: marginalisation of patients detained under part III of the MHA
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Sarah Markham
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Psychiatry ,RC435-571 - Published
- 2021
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66. Evaluation of two population screening programmes for BRCA1/2 founder mutations in the Australian Jewish community: a protocol paper
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Martin B Delatycki, Chris Jacobs, Bettina Meiser, Ian G Campbell, Lesley Andrews, Paul A James, Alison Trainer, AGNES BANKIER, Kristine Barlow-Stewart, Jane Tiller, Nicole E Cousens, Simone Rowley, Sakshi Mahale, Rajneesh Kaur, Leslie Burnett, and Suzanne Neil
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Medicine - Abstract
Introduction People of Ashkenazi Jewish (AJ) ancestry are more likely than unselected populations to have a BRCA1/2 pathogenic variant, which cause a significantly increased risk of breast, ovarian and prostate cancer. Three specific BRCA1/2 pathogenic variants, referred to as BRCA-Jewish founder mutations (B-JFM), account for >90% of BRCA1/2 pathogenic variants in people of AJ ancestry. Current practice of identifying eligible individuals for BRCA testing based on personal and/or family history has been shown to miss at least 50% of people who have one of these variants. Here we describe the protocol of the JeneScreen study—a study established to develop and evaluate two different population-based B-JFM screening programmes, offered to people of Jewish ancestry in Sydney and Melbourne, Australia.Methods and analysis To rmeasure the acceptability of population-based B-JFM screening in Australia, two screening programmes using different methodologies have been developed. The Sydney JeneScreen programme provides information and obtains informed consent by way of an online tool. The Melbourne JeneScreen programme does this by way of community sessions attended in person. Participants complete questionnaires to measure clinical and psychosocial outcomes at baseline, and for those who have testing, 2 weeks postresult. Participants who decline testing are sent a questionnaire regarding reasons for declining. Participants with a B-JFM are sent questionnaires 12-month and 24-month post-testing. The questionnaires incorporate validated scales, which measure anxiety, decisional conflict and regret, and test-related distress and positive experiences, and other items specifically developed or adapted for the study. These measures will be assessed for each programme and the two population-based B-JFM screening methods will be compared.Ethics and dissemination Institutional Human Research Ethics Committee approval was obtained from the South Eastern Area Health Service Human Research Ethics Committee: HREC Ref 16/125.Following the analysis of the study results, the findings will be disseminated widely through conferences and publications, and directly to participants in writing.
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- 2021
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67. Pilot randomised controlled trial of a patient navigation intervention to enhance engagement in the PrEP continuum among young Latino MSM: a protocol paper
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Aaron J Blashill, Janna R Gordon, Sarah A Rojas, Christian B Ramers, Chii-Dean Lin, Claudia M Carrizosa, Kelsey A Nogg, Kalina M Lamb, Nicholas C Lucido, Isaiah J Jones, David Rivera, Rosa A Cobian Aguilar, John P Brady, Martin Fuentes, and Kristen J Wells
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Medicine - Abstract
Introduction Men who have sex with men (MSM) are one of the most at-risk group for contracting HIV in the USA. However, the HIV epidemic impacts some groups of MSM disproportionately. Latino MSM comprise 25.1% of new HIV infections among MSM between the ages of 13 and 29 years. The daily medication tenofovir/emtricitabine was approved by the Food and Drug Administration for pre-exposure prophylaxis (PrEP) in 2012 and has demonstrated strong efficacy in reducing HIV acquisition.Methods and analysis Through extensive formative research, this study uses a pilot randomised controlled trial design and will examine the feasibility and acceptability of a patient navigation intervention designed to address multiple barriers to improve engagement in the PrEP continuum among 60 Latino MSM between the ages of 18 and 29 years. The patient navigation intervention will be compared with usual care plus written information to evaluate the feasibility and acceptability of the intervention and study methods and the intervention’s potential in improving PrEP continuum behaviours. The results will be reviewed for preparation for a future full-scale efficacy trial.Ethics and dissemination This study was approved by the institutional review board at San Diego State University and is registered at ClinicalTrials.gov. The intervention development process, plan and the results of this study will be shared through peer-reviewed journal publications, conference presentations and healthcare system and community presentations.Registration details Registered under the National Institutes of Health’s ClinicalTrials.gov (NCT04048382) on 7 August 2019 and approved by the San Diego State University (HS-2017–0187) institutional review board. This study began on 5 August 2019 and is estimated to continue through 31 March 2021. The clinical trial is in the pre-results stage.
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- 2021
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68. Evaluation of two population screening programmes for BRCA1/2 founder mutations in the Australian Jewish community: a protocol paper
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INTRODUCTION: People of Ashkenazi Jewish (AJ) ancestry are more likely than unselected populations to have a BRCA1/2 pathogenic variant, which cause a significantly increased risk of breast, ovarian and prostate cancer. Three specific BRCA1/2 pathogenic variants, referred to as BRCA-Jewish founder mutations (B-JFM), account for >90% of BRCA1/2 pathogenic variants in people of AJ ancestry. Current practice of identifying eligible individuals for BRCA testing based on personal and/or family history has been shown to miss at least 50% of people who have one of these variants. Here we describe the protocol of the JeneScreen study-a study established to develop and evaluate two different population-based B-JFM screening programmes, offered to people of Jewish ancestry in Sydney and Melbourne, Australia. METHODS AND ANALYSIS: To rmeasure the acceptability of population-based B-JFM screening in Australia, two screening programmes using different methodologies have been developed. The Sydney JeneScreen programme provides information and obtains informed consent by way of an online tool. The Melbourne JeneScreen programme does this by way of community sessions attended in person. Participants complete questionnaires to measure clinical and psychosocial outcomes at baseline, and for those who have testing, 2 weeks postresult. Participants who decline testing are sent a questionnaire regarding reasons for declining. Participants with a B-JFM are sent questionnaires 12-month and 24-month post-testing. The questionnaires incorporate validated scales, which measure anxiety, decisional conflict and regret, and test-related distress and positive experiences, and other items specifically developed or adapted for the study. These measures will be assessed for each programme and the two population-based B-JFM screening methods will be compared. ETHICS AND DISSEMINATION: Institutional Human Research Ethics Committee approval was obtained from the South Eastern Area Health Service Human
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- 2021
69. African authorship on African papers during the COVID-19 pandemic
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Lee A Wallis, Antoinette Vanessa Naidoo, Peter Hodkinson, and Lauren Lai King
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Medicine (General) ,R5-920 ,Infectious and parasitic diseases ,RC109-216 - Published
- 2021
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70. White paper on microbial anti-cancer therapy and prevention
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Neil S. Forbes, Robert S. Coffin, Liang Deng, Laura Evgin, Steve Fiering, Matthew Giacalone, Claudia Gravekamp, James L. Gulley, Hal Gunn, Robert M. Hoffman, Balveen Kaur, Ke Liu, Herbert Kim Lyerly, Ariel E. Marciscano, Eddie Moradian, Sheryl Ruppel, Daniel A. Saltzman, Peter J. Tattersall, Steve Thorne, Richard G. Vile, Halle Huihong Zhang, Shibin Zhou, and Grant McFadden
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Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract In this White Paper, we discuss the current state of microbial cancer therapy. This paper resulted from a meeting (‘Microbial Based Cancer Therapy’) at the US National Cancer Institute in the summer of 2017. Here, we define ‘Microbial Therapy’ to include both oncolytic viral therapy and bacterial anticancer therapy. Both of these fields exploit tumor-specific infectious microbes to treat cancer, have similar mechanisms of action, and are facing similar challenges to commercialization. We designed this paper to nucleate this growing field of microbial therapeutics and increase interactions between researchers in it and related fields. The authors of this paper include many primary researchers in this field. In this paper, we discuss the potential, status and opportunities for microbial therapy as well as strategies attempted to date and important questions that need to be addressed. The main areas that we think will have the greatest impact are immune stimulation, control of efficacy, control of delivery, and safety. There is much excitement about the potential of this field to treat currently intractable cancer. Much of the potential exists because these therapies utilize unique mechanisms of action, difficult to achieve with other biological or small molecule drugs. By better understanding and controlling these mechanisms, we will create new therapies that will become integral components of cancer care.
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- 2018
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71. Position paper on patient safety.
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Batista, Aida, Polidori, Piera, and Kohl, Stephanie
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- 2021
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72. Developing an Australian multi-module clinical quality registry for gynaecological cancers: a protocol paper
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John R Zalcberg, Yee Leung, Natalie Heriot, Alison Brand, Paul Cohen, Sue Hegarty, Simon Hyde, and Robert Rome
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Medicine - Abstract
IntroductionGynaecological cancers collectively account for almost 10% of cancer diagnoses made in Australian women. The extent of variation in gynaecological cancer survival rates and treatment outcomes across Australia is not well documented. The purpose of the clinical quality registry described in this paper is to systematically monitor and improve quality of care provided to these women, and facilitate clinical process improvements to ensure better patient outcomes and greater adherence to best practice care. The registry infrastructure has been developed in conjunction alongside the inaugural ovarian, tubal and peritoneal (OTP) module, allowing for concurrent piloting of the methodology and one module. Additional tumour modules will be developed in time to cover the other gynaecological tumour types.Method and analysisThe National Gynae-Oncology Registry (NGOR) aims to capture clinical data on all newly diagnosed cancers of the uterus, ovary, fallopian tubes, peritoneum, cervix, vulva and vagina in Australia with a view to using these data to support improved clinical care and increased adherence to ‘best practice’. Data are sourced from existing clinical databases maintained by clinicians and/or hospital gynaecological cancer units. A pilot phase incorporating only OTP cancers has recently been conducted to assess the feasibility of the registry methodology and assess the support of a quality initiative of this nature among clinicians and other key stakeholders.Ethics and disseminationThe NGOR has received National Mutual Acceptance (NMA) ethics approval from Monash Health Human Research Ethics Committee (HREC), NMA HREC Reference Number: HREC/17/MonH/198. We also have approval from Mercy Health HREC and University of Tasmania HREC. Data will be routinely reported back to participating sites illustrating their performance against measures of agreed best practice. It is through this feedback system that the registry will support changes to quality of care and improved patient outcomes.
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- 2020
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73. Identifying challenges to implementation of clinical practice guidelines for sentinel lymph node biopsy in patients with melanoma in Australia: Protocol paper for a mixed methods study
- Abstract
Introduction Sentinel lymph node biopsy (SLNB) is a diagnostic procedure developed in the 1990s. It is currently used to stage patients with primary cutaneous melanoma, provide prognostic information and guide management. The Australian Clinical Practice Guidelines state that SLNB should be considered for patients with cutaneous melanoma >1mm in thickness (or >0.8mm with high-risk pathology features). Until recently, sentinel lymph node (SLN) status was used to identify patients who might benefit from a completion lymph node dissection, a procedure that is no longer routinely recommended. SLN status is now also being used to identify patients who might benefit from systemic adjuvant therapies such as anti-programmed cell death 1 (PD1) checkpoint inhibitor immunotherapy or BRAFdirected molecular targeted therapy, treatments that have significantly improved relapse-free survival for patients with resected stage III melanoma and improved overall survival of patients with unresectable stage III and stage IV melanoma. Australian and international data indicate that approximately half of eligible patients receive an SLNB. Methods and analysis This mixed-methods study seeks to understand the structural, contextual and cultural factors affecting implementation of the SLNB guidelines. Data collection will include: (1) cross-sectional questionnaires and semistructured interviews with general practitioners and dermatologists; (2) semistructured interviews with other healthcare professionals involved in the diagnosis and early definitive care of melanoma patients and key stakeholders including researchers, representatives of professional colleges, training organisations and consumer melanoma groups; and (3) documentary analysis of documents from government, health services and non-government organisations. Descriptive analyses and multivariable regression models will be used to examine factors related to SLNB practices and attitudes. Qualitative data will be analysed using them
- Published
- 2020
74. Identifying challenges to implementation of clinical practice guidelines for sentinel lymph node biopsy in patients with melanoma in Australia: protocol paper for a mixed methods study
- Abstract
INTRODUCTION: Sentinel lymph node biopsy (SLNB) is a diagnostic procedure developed in the 1990s. It is currently used to stage patients with primary cutaneous melanoma, provide prognostic information and guide management. The Australian Clinical Practice Guidelines state that SLNB should be considered for patients with cutaneous melanoma >1 mm in thickness (or >0.8 mm with high-risk pathology features). Until recently, sentinel lymph node (SLN) status was used to identify patients who might benefit from a completion lymph node dissection, a procedure that is no longer routinely recommended. SLN status is now also being used to identify patients who might benefit from systemic adjuvant therapies such as anti-programmed cell death 1 (PD1) checkpoint inhibitor immunotherapy or BRAF-directed molecular targeted therapy, treatments that have significantly improved relapse-free survival for patients with resected stage III melanoma and improved overall survival of patients with unresectable stage III and stage IV melanoma. Australian and international data indicate that approximately half of eligible patients receive an SLNB. METHODS AND ANALYSIS: This mixed-methods study seeks to understand the structural, contextual and cultural factors affecting implementation of the SLNB guidelines. Data collection will include: (1) cross-sectional questionnaires and semistructured interviews with general practitioners and dermatologists; (2) semistructured interviews with other healthcare professionals involved in the diagnosis and early definitive care of melanoma patients and key stakeholders including researchers, representatives of professional colleges, training organisations and consumer melanoma groups; and (3) documentary analysis of documents from government, health services and non-government organisations. Descriptive analyses and multivariable regression models will be used to examine factors related to SLNB practices and attitudes. Qualitative data will be analysed using
- Published
- 2020
75. EAHP general assembly updates position paper on clinical trials.
- Author
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Kohl S
- Abstract
Competing Interests: Competing interests: None declared.
- Published
- 2022
- Full Text
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76. NHS still reliant on paper patient notes and drug charts despite electronic upgrades, The BMJfinds.
- Author
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Best, Jo
- Subjects
TIME ,MEDICATION errors ,NATIONAL health services ,PHARMACY databases ,DRUGS ,DRUG prescribing ,ACCESS to information ,PHYSICIAN practice patterns ,ELECTRONIC health records ,NURSING records ,PATIENT safety - Published
- 2023
- Full Text
- View/download PDF
77. Identifying challenges to implementation of clinical practice guidelines for sentinel lymph node biopsy in patients with melanoma in Australia: protocol paper for a mixed methods study
- Author
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Michael Henderson, Frances Rapport, Rachael L Morton, John F Thompson, Andrea L Smith, Anne E Cust, Graham J Mann, Caroline G Watts, David E Gyorki, Angela M Hong, John W Kelly, Victoria J Mar, Robyn PM Saw, Richard A Scolyer, and Andrew J Spillane
- Subjects
Medicine - Abstract
IntroductionSentinel lymph node biopsy (SLNB) is a diagnostic procedure developed in the 1990s. It is currently used to stage patients with primary cutaneous melanoma, provide prognostic information and guide management. The Australian Clinical Practice Guidelines state that SLNB should be considered for patients with cutaneous melanoma >1 mm in thickness (or >0.8 mm with high-risk pathology features). Until recently, sentinel lymph node (SLN) status was used to identify patients who might benefit from a completion lymph node dissection, a procedure that is no longer routinely recommended. SLN status is now also being used to identify patients who might benefit from systemic adjuvant therapies such as anti-programmed cell death 1 (PD1) checkpoint inhibitor immunotherapy or BRAF-directed molecular targeted therapy, treatments that have significantly improved relapse-free survival for patients with resected stage III melanoma and improved overall survival of patients with unresectable stage III and stage IV melanoma. Australian and international data indicate that approximately half of eligible patients receive an SLNB.Methods and analysisThis mixed-methods study seeks to understand the structural, contextual and cultural factors affecting implementation of the SLNB guidelines. Data collection will include: (1) cross-sectional questionnaires and semistructured interviews with general practitioners and dermatologists; (2) semistructured interviews with other healthcare professionals involved in the diagnosis and early definitive care of melanoma patients and key stakeholders including researchers, representatives of professional colleges, training organisations and consumer melanoma groups; and (3) documentary analysis of documents from government, health services and non-government organisations. Descriptive analyses and multivariable regression models will be used to examine factors related to SLNB practices and attitudes. Qualitative data will be analysed using thematic analysis.Ethics and disseminationEthics approval has been granted by the University of Sydney. Results will be disseminated through publications and presentations to clinicians, patients, policymakers and researchers and will inform the development of strategies for implementing SLNB guidelines in Australia.
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- 2020
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78. Free Papers 6-8: End-of-Life-Care.
- Published
- 2023
79. Abstracts and Highlight Papers of the 38th Annual European Society of Regional Anaesthesia & Pain Therapy (ESRA) Congress 2019: Late Breakers.
- Published
- 2019
80. Abstracts and Highlight Papers of the 38th Annual European Society of Regional Anaesthesia & Pain Therapy (ESRA) Congress 2019: E-Poster Viewing Abstracts.
- Published
- 2019
81. Abstracts and Highlight Papers of the 38th Annual European Society of Regional Anesthesia & Pain Therapy (ESRA) Congress 2019: Invited Speakers.
- Published
- 2019
82. Cross-sectional observation study to investigate the impact of risk-based stratification on care pathways for patients with chronic kidney disease: protocol paper
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Harjeet Kaur Bhachu
- Subjects
Medicine - Abstract
IntroductionChronic kidney disease (CKD) management in the UK is usually primary care based, with National Institute for Health and Care Excellence (NICE) guidelines defining criteria for referral to secondary care nephrology services. Estimated glomerular filtration rate (eGFR) is commonly used to guide timing of referrals and preparation of patients approaching renal replacement therapy. However, eGFR lacks sensitivity for progression to end-stage renal failure; as a consequence, the international guideline group, Kidney Disease: Improving Global Outcomes has recommended the use of a risk calculator. The validated Kidney Failure Risk Equation may enable increased precision for the management of patients with CKD; however, there is little evidence to date for the implication of its use in routine clinical practice. This study will aim to determine the impact of the Kidney Failure Risk Equation on the redesignation of patients with CKD in the UK for referral to secondary care, compared with NICE CKD guidance.Method and analysisThis is a cross-sectional population-based observational study using The Health Improvement Network database to identify the impact of risk-based designation for referral into secondary care for patients with CKD in the UK. Adult patients registered in primary care and active in the database within the period 1 January 2016 to 31 March 2017 with confirmed CKD will be analysed. The proportion of patients who meet defined risk thresholds will be cross-referenced with the current NICE guideline recommendations for referral into secondary care along with an evaluation of urinary albumin–creatinine ratio monitoring.Ethics and disseminationApproval was granted by The Health Improvement Network Scientific Review Committee (Reference number: 18THIN061). Study outcomes will inform national and international guidelines including the next version of the NICE CKD guideline. Dissemination of findings will also be through publication in a peer-reviewed journal, presentation at conferences and inclusion in the core resources of the Think Kidneys programme.
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- 2019
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83. Defining certainty of net benefit: a GRADE concept paper
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Brian S Alper, Peter Oettgen, Ilkka Kunnamo, Alfonso Iorio, Mohammed Toseef Ansari, Amir Qaseem, Monica Hultcrantz, and Holger J Schünemann
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Medicine - Abstract
Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology is used to assess and report certainty of evidence and strength of recommendations. This GRADE concept article is not GRADE guidance but introduces certainty of net benefit, defined as the certainty that the balance between desirable and undesirable health effects is favourable. Determining certainty of net benefit requires considering certainty of effect estimates, the expected importance of outcomes and variability in importance, and the interaction of these concepts. Certainty of net harm is the certainty that the net effect is unfavourable. Guideline panels using or testing this approach might limit strong recommendations to actions with a high certainty of net benefit or against actions with a moderate or high certainty of net harm. Recommendations may differ in direction or strength from that suggested by the certainty of net benefit or harm when influenced by cost, equity, acceptability or feasibility.
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- 2019
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84. Position paper on pharmacy preparations and compounding
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Stephanie Kohl
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medicine.medical_specialty ,business.industry ,Compounding ,Family medicine ,Position paper ,Medicine ,Pharmacy ,General Pharmacology, Toxicology and Pharmaceutics ,Hospital pharmacy ,News ,business - Abstract
At the beginning of October, the member organisations of the European Association of Hospital Pharmacists (EAHP) adopted a new position paper on pharmacy preparations and compounding. The position aims at providing information about the practice of pharmacy preparations and compounding in hospitals and asks for a stronger embedment of compounding and reconstitution practices in European hospital pharmacies, linked to increasing capacity and training. The different sections of EAHP’s position paper touch on the importance of compounding for addressing patient needs, the involvement of hospital pharmacies in reconstitution practices and the role of hospital pharmacists in the preparation and use of advanced therapy medicinal products (ATMPs). Linked to personalised medication, it shares information on the engagement of hospital pharmacists and the adjustments …
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- 2020
85. Occupational exposure to soft paper dust and mortality.
- Author
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Torén, Kjell, Neitzel, Richard, Sallsten, Gerd, and Andersson, Eva
- Abstract
Objectives: Occupational exposure to soft paper dust is associated with impaired lung function. Whether there is an increased risk for asthma or chronic obstructive pulmonary disease (COPD) is unclear.Methods: We studied 7870 workers from three Swedish soft paper mills, and defined high-exposed workers, as having been exposed to soft paper dust exceeding 5 mg/m3 for at least 5 years. The remaining workers were classified as 'low exposed'. Person-years at risk were calculated and stratified according to gender, age and calendar-year. The follow-up time was from 1960 to 2013. The expected numbers of deaths were calculated using the Swedish population as reference and standardised mortality ratios (SMRs) with 95% CIs were assessed.Results: There was an increased mortality due to obstructive lung disease (asthma and COPD), among high-exposed workers, SMR 1.89, 95% CI 1.20 to 2.83, based on 23 observed cases. High-exposed workers had an increased mortality from asthma, SMR 4.13, 95% CI 1.78 to 8.14, based on eight observed cases. The increased asthma mortality was also observed among high-exposed men, SMR 4.38, 95% CI 1.42 to 10.2, based on five observed cases. The asthma mortality among low-exposed workers, both men and women, was not increased. The COPD mortality was not clearly increased among high-exposed workers (SMR 1.52, 95% CI 0.85 to 2.50).Conclusion: High occupational exposure to soft paper dust increases the mortality due to asthma, and the results suggest that soft paper dust levels in workplaces should be below 5 mg/m3. [ABSTRACT FROM AUTHOR]- Published
- 2020
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86. Position paper on patient safety
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Aida Batista, Piera Polidori, and Stephanie Kohl
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business.industry ,EAHP position paper ,MEDLINE ,Pharmacy ,medicine.disease ,030226 pharmacology & pharmacy ,03 medical and health sciences ,Patient safety ,0302 clinical medicine ,Harm ,Medicine ,Position paper ,030212 general & internal medicine ,Medical emergency ,General Pharmacology, Toxicology and Pharmaceutics ,Hospital pharmacy ,Formulary ,business ,Risk assessment - Abstract
Patient safety and quality of care are a priority for hospital pharmacists all across Europe. The European Association of Hospital Pharmacists (EAHP) has manifested the importance of patient safety for hospital pharmacy practice in a dedicated section of its European Statements of Hospital Pharmacy.1 As stewards of patients’ medication safety, hospital pharmacists are the key stakeholders ensuring the safe, effective and rational use of medicines by upholding the ‘rights’ of patients. This includes improving the safety of using medications, especially high-risk medication and look-alike and sound-alike (LASA) medications, through their close surveillance as well as advising on the most appropriate use of medicines. While some prescribing, dispensing and administration may not cause harm, it may not be cost-effective or beneficial for the patient. The abovementioned phrase 'appropriate use' encompasses a multitude of situations. Patient safety, which lies at the heart of all representations made by EAHP and its members, covers many aspects. EAHP’s position on patient safety specifically focuses on medication safety. In particular, medication errors, which occur when a medicine has been inappropriately prescribed, prepared, dispensed or administered to a patient, are a key concern for hospital pharmacists. Throughout the medication use process specific measures must be taken by healthcare professionals (figure 1). For hospital pharmacists these include improving medication safety by reducing available harm through using risk assessment procedures. Figure 1 The medication use process from a patient perspective. Even before a patient is treated for a specific disease, hospital pharmacists ensure the safety of the patient throughout the care pathway. These include actions linked to the hospital formulary, such as selecting narrow-spectrum antibiotics to prevent resistance, and implementation of the decision of the Drug and Therapeutics Committee, the proper selection and procurement as well as the application of appropriate quality assurance strategies for the medication use processes to …
- Published
- 2020
87. White paper on microbial anti-cancer therapy and prevention
- Author
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Ke Liu, Steve H. Thorne, Daniel A. Saltzman, Peter Tattersall, Grant McFadden, Liang Deng, Balveen Kaur, Laura Evgin, Steve Fiering, Richard G. Vile, Sheryl Ruppel, Herbert Kim Lyerly, Robert M. Hoffman, James L. Gulley, Robert Coffin, Matthew Giacalone, Claudia Gravekamp, Ariel E. Marciscano, Halle Huihong Zhang, Neil S. Forbes, Eddie Moradian, Shibin Zhou, and Hal Gunn
- Subjects
0301 basic medicine ,Cancer Research ,medicine.medical_specialty ,Genetic Vectors ,Immunology ,Treatment outcome ,Drug Evaluation, Preclinical ,Cancer therapy ,Cancer Vaccines ,lcsh:RC254-282 ,03 medical and health sciences ,0302 clinical medicine ,White paper ,Neoplasms ,medicine ,Animals ,Humans ,Immunology and Allergy ,Combined Modality Therapy ,Viral therapy ,Intensive care medicine ,Oncolytic Virotherapy ,Pharmacology ,Immune Stimulation ,Bacteria ,business.industry ,Clinical Studies as Topic ,Neoplasms therapy ,Cancer ,medicine.disease ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Biological Therapy ,Treatment Outcome ,030104 developmental biology ,Oncology ,030220 oncology & carcinogenesis ,Viruses ,Molecular Medicine ,Genetic Engineering ,business ,Research Article - Abstract
In this White Paper, we discuss the current state of microbial cancer therapy. This paper resulted from a meeting (‘Microbial Based Cancer Therapy’) at the US National Cancer Institute in the summer of 2017. Here, we define ‘Microbial Therapy’ to include both oncolytic viral therapy and bacterial anticancer therapy. Both of these fields exploit tumor-specific infectious microbes to treat cancer, have similar mechanisms of action, and are facing similar challenges to commercialization. We designed this paper to nucleate this growing field of microbial therapeutics and increase interactions between researchers in it and related fields. The authors of this paper include many primary researchers in this field. In this paper, we discuss the potential, status and opportunities for microbial therapy as well as strategies attempted to date and important questions that need to be addressed. The main areas that we think will have the greatest impact are immune stimulation, control of efficacy, control of delivery, and safety. There is much excitement about the potential of this field to treat currently intractable cancer. Much of the potential exists because these therapies utilize unique mechanisms of action, difficult to achieve with other biological or small molecule drugs. By better understanding and controlling these mechanisms, we will create new therapies that will become integral components of cancer care.
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- 2018
88. Summary of landmark papers published between August 2018 and May 2019.
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CANCER chemotherapy ,OVARIAN cancer treatment ,PEMBROLIZUMAB ,TREATMENT of endometrial cancer ,CANCER relapse ,CERVICAL cancer treatment - Published
- 2019
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89. ASPiH Conference 2019 keynote paper. Quality improvement through simulation: a missed opportunity?
- Author
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Paul O'Connor
- Subjects
Process management ,Quality management ,Computer science ,business.industry ,Aviation ,Psychological intervention ,Health Informatics ,Paper quality ,EDUCATION ,Editorial ,Modeling and Simulation ,Health care ,HEALTH-CARE ,Health education ,Missed opportunity ,business ,Working environment ,Simulation - Abstract
As the use of simulation has become more established in the delivery of healthcare education and training, there has been a corresponding increase in healthcare simulation research. Simulation-based research can be divided into research about simulation (answers research questions in which the focus is on simulation itself) and research through simulation (simulation as a method/tool for research). However, there are barriers, particularly for smaller less well-resourced simulation centres, that may prohibit participation in research. Therefore, it is suggested that quality improvement (QI) through simulation may be a pragmatic way in which simulation centres of all sizes can contribute to improving patient care beyond education and training. QI is defined as systematic, data-guided activities designed to bring about immediate, positive changes in the delivery of healthcare. Although not the case in healthcare, other industries routinely used simulation to support QI. For example, in aviation simulation is used to inform the design of the working environment, the appropriate use of technology, to exercise emergency procedures and to ‘re-fly’ flights following an adverse event as part of the mishap investigation. Integrating simulation within healthcare QI can support the development of novel interventions as well helping to address heretofore intractable issues.
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- 2020
90. Femoroacetabular impingement syndrome and labral injuries: grading the evidence on diagnosis and non-operative treatment-a statement paper commissioned by the Danish Society of Sports Physical Therapy (DSSF).
- Author
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Ishøi L, Nielsen MF, Krommes K, Husted RS, Hölmich P, Pedersen LL, and Thorborg K
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- Arthroscopy, Denmark, Hip Joint, Humans, Physical Therapy Modalities, Range of Motion, Articular, Femoracetabular Impingement diagnosis, Femoracetabular Impingement therapy
- Abstract
This statement summarises and appraises the evidence on diagnostic tests and clinical information, and non-operative treatment of femoroacetabular impingement (FAI) syndrome and labral injuries. We included studies based on the highest available level of evidence as judged by study design. We evaluated the certainty of evidence using the Grading of Recommendations Assessment Development and Evaluation framework. We found 29 studies reporting 23 clinical tests and 14 different forms of clinical information, respectively. Restricted internal hip rotation in 0° hip flexion with or without pain was best to rule in FAI syndrome (low diagnostic effectiveness; low quality of evidence; interpretation of evidence: may increase post-test probability slightly), whereas no pain in Flexion Adduction Internal Rotation test or no restricted range of motion in Flexion Abduction External Rotation test compared with the unaffected side were best to rule out (very low to high diagnostic effectiveness; very low to moderate quality of evidence; interpretation of evidence: very uncertain, but may reduce post-test probability slightly). No forms of clinical information were found useful for diagnosis. For treatment of FAI syndrome, 14 randomised controlled trials were found. Prescribed physiotherapy, consisting of hip strengthening, hip joint manual therapy techniques, functional activity-specific retraining and education showed a small to medium effect size compared with a combination of passive modalities, stretching and advice (very low to low quality of evidence; interpretation of evidence: very uncertain, but may slightly improve outcomes). Prescribed physiotherapy was, however, inferior to hip arthroscopy (small effect size; moderate quality of evidence; interpretation of evidence: hip arthroscopy probably increases outcome slightly). For both domains, the overall quality of evidence ranged from very low to moderate indicating that future research on diagnosis and treatment may alter the conclusions from this review., Competing Interests: Competing interests: KT is Deputy Editor in BJSM, and have received grants from the Danish Society of Sports Physical Therapy., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2021
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91. Ten papers for teachers of evidence-based medicine and health care: Sicily workshop 2019.
- Author
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Nunan D, Lindblad A, Widyahening IS, Bernardo WM, Chi CC, Cowdell F, Becker K, Constantine S, East C, Myrhaug HT, Johnson SG, Jack E, Thompson R, Achilleos H, Berg RC, Snibsøer AK, Puscasiu L, Bartelink ME, van Peet PG, Berti F, Tilson J, Tikkinen KA, Albarqouni L, and Hoegen P
- Subjects
- Humans, Sicily, Delivery of Health Care, Evidence-Based Medicine
- Abstract
Competing Interests: Competing interests: DN has received expenses and fees for his media work. He holds grant funding from the NIHR School of Primary Care Research and the Royal College of General Practitioners. On occasion, he receives expenses for teaching EBM. ISW reports personal fees from various universities and hospitals around Indonesia for teaching EBM, outside the submitted work. SC occasionally receives expenses for teaching EBM at academic conferences and hospitals around Japan. EJ receives a regular income for his employed NHS work through Yealm Medical Centre and PenARC. He receives expenses for teaching EBM. In March 2019 he received a one-off consultancy fee for 2-days work for Zavamed (work unrelated to this article). PH works as a teacher in EBP and is currently conducting a PhD research that is funded by Avans University of Applied Science. He receives expenses for lectures at seminars and workshops on EBP. HA has received funding from Health Education England to attend the EBHC 2019 meeting. She is also a visiting tutor of Evidence-Based Child Health at the UCL Great Ormond Street Institute of Child Health, London. RCB works as a teacher in EBP and receives a regular income for her employed NIPH (Department of Reviews and health technology assessments) work. None to declare – AL, WMB, C-CC, FB, CE, HTM, SGJ, RT, M-LELB, LP, AKS, PGvP, FB, KAOT, LA.
- Published
- 2021
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92. Fungal microbiome (mycobiome) and virome of the lacrimal sac in patients with PANDO: the lacriome paper 5.
- Author
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Ali, Mohammad Javed
- Abstract
Purpose To study the fungal microbiome (mycobiome) and the virome of the lacrimal sacs in patients with primary acquired nasolacrimal duct obstruction (PANDO). Methods A prospective study was performed on 10 consecutive samples of the lacrimal sac contents obtained from patients with PANDO. The samples were obtained from the lacrimal sacs under endoscopy guidance and immediately transported on ice to the laboratory. Following DNA extraction and library preparation, a whole shotgun metagenome sequencing was performed on the Illumina platform (NOVASEQ 6000). The fungal internal transcript spacer analysis was performed using the PIPITS v2.7. The viral taxonomy profiling was performed using Kraken2 against the virus database. Results The taxonomic hit distribution across the lacrimal sac samples showed rich fungal diversity (4 phyla, 12 classed, 21 families and 26 genera). The major phyla were Ascomycota and Basidiomycota, and the key genera identified were Alternaria, Hyphopichia, Malassezia, Aspergillus and Epicoccum. The virome analysis identified 13 phyla, 15 classes and 27 families. The viruses were commonly from the families Poxviridae, Retroviridae, Siphoviridae and Myoviridae, Poxviridae being the most prevalent family. The BeAn 58058 virus, a member of the Poxviridae family, was the most abundant in all the samples. Conclusion The present study is the first whole metagenome sequencing exclusively of the fungal microbiome and virome from the lacrimal sacs of patients with PANDO. The lacrimal sacs harbour diverse fungal and viral communities with distinct ecosystem dynamics. Further studies of their functions and interactions with the hosts would provide valuable insights. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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- View/download PDF
93. Comparison between electronic and paper versions of patient-reported outcome measures in subjects with chronic obstructive pulmonary disease: an observational study with a cross-over administration.
- Author
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Koichi Nishimura, Masaaki Kusunose, Ryo Sanda, Yousuke Tsuji, Yoshinori Hasegawa, and Toru Oga
- Abstract
Objectives A wide range of electronic devices can be used for data collection of patient-reported outcome (PRO) measures in subjects with chronic obstructive pulmonary disease (COPD). Although comparisons between electronic and paper-based PRO measures have been undertaken in asthmatics, it is currently uncertain whether electronic questionnaires work equally as well as paper versions in elderly subjects with COPD. The aim of this study was to compare the responses to paper and electronic versions of the Evaluating Respiratory Symptoms in COPD (E-RS) and the COPD Assessment Test (CAT). Design A randomised cross-over design was used to compare the responses to paper and electronic versions of the two tools. The interval between the two administrations was 1 week. Setting Electronic versions were self-administered under supervision using a tablet computer at our outpatient clinic (secondary care hospital in Japan) while paper questionnaires completed at home were requested to be returned by mail. It was intended that half of the patients completed the electronic versions of both questionnaires first, followed by the paper versions while the other half completed the paper versions first. Participants Eighty-one subjects with stable COPD were included. Results The E-RS total scores (possible range 0–40) were 6.8±7.4 and 5.0±6.6 in the paper-based and electronic versions, respectively, and the CAT scores (possible range 0–40) were 10.0±7.4 and 8.6±7.8. In both questionnaires, higher scores indicate worse status. The relationship between electronic and paper versions showed significant reliability for both the E-RS total score and CAT score (intraclass correlation coefficient=0.82 and 0.89, respectively; both p<0.001). However, both the E-RS total and CAT scores were significantly higher in the paper versions (p<0.05). Conclusions In both cases, the two versions of the same questionnaire cannot be used interchangeably even though they have both been validated. [ABSTRACT FROM AUTHOR]
- Published
- 2019
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94. The 100 most cited papers on retinal detachment: a bibliographic perspective.
- Author
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Grzybowski, Andrzej, Shtayer, Chen, Schwartz, Stephen G., and Moisseiev, Elad
- Abstract
The 100 most cited papers on retinal detachment (RD) were analysed using a bibliographic study. The bibliographic databases of the ISI Web of Knowledge were searched, limited to research articles published between 1965 and 2020 in peer- reviewed journals. The papers were ranked in order of number of citations since publication. Ninety of the 100 most cited papers on RD were published in 12 ophthalmology journals, with 74 of them published in American Journal of Ophthalmology (n=31), Ophthalmology (n=23), Archives of Ophthalmology (n=10) and Investigative Ophthalmology and Visual Science (n=10); the remaining 10 papers were published in 8 journals from other fields of medical research. All papers in the top 100 were published in English. The 100 most cited papers on RD originated from 12 different countries, with the majority (72 papers) originating from the USA. The 100 identified papers represent a mix of clinical trials and animal/laboratory studies. This bibliographic study provides a unique perspective and insight into some of the most influential contributions in RD understanding and management over the last 55 years. [ABSTRACT FROM AUTHOR]
- Published
- 2022
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95. Use of the ONCO-TreC electronic diary compared with a standard paper diary to improve adherence to oral cancer therapy in patients with solid and haematological tumours: protocol for a randomised controlled trial
- Author
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Alessandro Passardi, Patrizia Serra, Orazio Caffo, Carla Masini, Erika Brugugnoli, Roberto Vespignani, Valeria Giardino, Elisabetta Petracci, Giulia Bartolini, Francesco Sullo, Cecilia Anesi, Marco Dianti, Claudio Eccher, Enrico Maria Piras, Lorenzo Gios, Annalisa Campomori, Valentina Oberosler, and Stefano Forti
- Subjects
SARS-CoV-2 ,oral medicine ,COVID-19 ,information management ,General Medicine ,Oncology ,Hematologic Neoplasms ,Humans ,Medicine ,Mouth Neoplasms ,Electronics ,Randomized Controlled Trials as Topic - Abstract
IntroductionONCO-TreC platform consists of a mobile application delivered to patients as electronic diary and a web-based dashboard managed by healthcare professionals. We aim to compare the effectiveness of ONCO-TreC electronic diary with a standard paper diary, in improving adherence to oral cancer therapy in patients with solid and haematological tumours.Methods and analysisThis is an open label, superiority, randomised controlled trial conducted in two Italian oncology units. Patients will be randomised with a 1:1 ratio to electronic or paper diary. For both groups a counsellor will be responsible for drug and diary delivery. The evaluation period will end after six cycles of therapy. The primary aim is to compare the proportion of non-adherent patients in the two arms. Adherence will be measured through pill count; anyone who takes less than 90% of the total prescribed drug dose will be considered non-adherent. Assuming a percentage of non-adherent patients to oral therapy of 40% in arm B, and a 60% reduction in this percentage in arm A, a sample of 124 patients will provide 80% power to identify an absolute difference greater than 24 percentage points using a bilateral Fisher’s exact test with a significance level of 0.05. Considering a dropout rate of 10%, approximately 136 patients will have to be enrolled. The primary analysis will be performed on the intention-to-treat population. Secondary aims are to describe the reasons for non-adherence, the level of satisfaction of patients and healthcare professionals with the paper and electronic diary, and the impact of non-adherence in terms of healthcare costs.Ethics and disseminationEthical approval was obtained from Romagna Ethics Committee (CEROM), study ID 2108, prot. n. IRST 100.28 of 10/04/2020. Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations.Protocol versionVersion 2, 6 April 2021.Trial registration numberNCT04826458.
- Published
- 2022
96. A CHecklist for statistical Assessment of Medical Papers (the CHAMP statement): explanation and elaboration.
- Author
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Mansournia MA, Collins GS, Nielsen RO, Nazemipour M, Jewell NP, Altman DG, and Campbell MJ
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- Delivery of Health Care, Humans, Peer Review, Research, Sports Medicine statistics & numerical data, Biomedical Research, Checklist, Research Design, Statistics as Topic standards
- Abstract
Misuse of statistics in medical and sports science research is common and may lead to detrimental consequences to healthcare. Many authors, editors and peer reviewers of medical papers will not have expert knowledge of statistics or may be unconvinced about the importance of applying correct statistics in medical research. Although there are guidelines on reporting statistics in medical papers, a checklist on the more general and commonly seen aspects of statistics to assess when peer-reviewing an article is needed. In this article, we propose a CHecklist for statistical Assessment of Medical Papers (CHAMP) comprising 30 items related to the design and conduct, data analysis, reporting and presentation, and interpretation of a research paper. While CHAMP is primarily aimed at editors and peer reviewers during the statistical assessment of a medical paper, we believe it will serve as a useful reference to improve authors' and readers' practice in their use of statistics in medical research. We strongly encourage editors and peer reviewers to consult CHAMP when assessing manuscripts for potential publication. Authors also may apply CHAMP to ensure the validity of their statistical approach and reporting of medical research, and readers may consider using CHAMP to enhance their statistical assessment of a paper., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2021
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97. CHecklist for statistical Assessment of Medical Papers: the CHAMP statement.
- Author
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Mansournia MA, Collins GS, Nielsen RO, Nazemipour M, Jewell NP, Altman DG, and Campbell MJ
- Subjects
- Humans, Checklist, Research Design
- Abstract
Competing Interests: Competing interests: None declared.
- Published
- 2021
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98. Ethical issues in two parallel trials of personalised criteria for implantation of implantable cardioverter defibrillators for primary prevention: the PROFID project-a position paper.
- Author
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Willems D, Bak M, Tan H, Lindinger G, Kocar A, Seperhi Shamloo A, Schmidt G, Hindricks G, and Dagres N
- Subjects
- Death, Sudden, Cardiac etiology, Humans, Artificial Intelligence, Clinical Trials as Topic ethics, Death, Sudden, Cardiac prevention & control, Decision Making, Defibrillators, Implantable, Myocardial Infarction complications, Primary Prevention ethics
- Abstract
Aim: To discuss ethical issues related to a complex study (PROFID) involving the development of a new, partly artificial intelligence-based, prediction model to enable personalised decision-making about the implantation of an implantable cardioverter defibrillator (ICD) in postmyocardial infarction patients, and a parallel non-inferiority and superiority trial to test decision-making informed by that model., Method: The position expressed in this paper is based on an analysis of the PROFID trials using concepts from high-profile publications in the ethical literature., Results: We identify ethical issues related to the testing of the model in the treatment setting, and to both the superiority and the non-inferiority trial. We underline the need for ethical-empirical studies about these issues, also among patients, as a parallel to the actual trials. The number of ethics committees involved is an organisational, but also an ethical challenge., Conclusion: The PROFID trials, and probably other studies of similar scale and complexity, raise questions that deserve dedicated parallel ethics and social science research, but do not constitute a generic obstacle. A harmonisation procedure, comparable to the Voluntary Harmonization Procedure (VHP) for medication trials, could be needed for this type of trials., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2021
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99. CHecklist for statistical Assessment of Medical Papers: the CHAMP statement
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Douglas G. Altman, Michael J. Campbell, Nicholas P. Jewell, Maryam Nazemipour, Rasmus Nielsen, Gary S. Collins, and Mohammad Ali Mansournia
- Subjects
medicine.medical_specialty ,media_common.quotation_subject ,Physical Therapy, Sports Therapy and Rehabilitation ,Strengthening the reporting of observational studies in epidemiology ,Article ,Epidemiology ,medicine ,Humans ,Orthopedics and Sports Medicine ,Quality (business) ,media_common ,Medical education ,education ,research ,Public health ,Consolidated Standards of Reporting Trials ,methodology ,General Medicine ,Transparency (behavior) ,Checklist ,statistics ,Research Design ,epidemiology ,Biostatistics ,Psychology - Abstract
Misuse of statistics in medical and sports science research is common and may lead to detrimental consequences to healthcare. Many authors, editors and peer reviewers of medical papers will not have expert knowledge of statistics or may be unconvinced about the importance of applying correct statistics in medical research. Although there are guidelines on reporting statistics in medical papers, a checklist on the more general and commonly seen aspects of statistics to assess when peer-reviewing an article is needed. In this article, we propose a CHecklist for statistical Assessment of Medical Papers (CHAMP) comprising 30 items related to the design and conduct, data analysis, reporting and presentation, and interpretation of a research paper. While CHAMP is primarily aimed at editors and peer reviewers during the statistical assessment of a medical paper, we believe it will serve as a useful reference to improve authors’ and readers’ practice in their use of statistics in medical research. We strongly encourage editors and peer reviewers to consult CHAMP when assessing manuscripts for potential publication. Authors also may apply CHAMP to ensure the validity of their statistical approach and reporting of medical research, and readers may consider using CHAMP to enhance their statistical assessment of a paper.
- Published
- 2021
100. Position paper on an ageing society.
- Author
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Süle, András, Miljković, Nenad, Polidori, Piera, and Kohl, Stephanie
- Published
- 2019
- Full Text
- View/download PDF
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