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1دورية أكاديمية
المؤلفون: Vaidya, Jayant S, Bulsara, Max, Baum, Michael, Wenz, Frederik, Massarut, Samuele, Pigorsch, Steffi, Alvarado, Michael, Douek, Michael, Saunders, Christobel, Flyger, Henrik L, Eiermann, Wolfgang, Brew-Graves, Chris, Williams, Norman R, Potyka, Ingrid, Roberts, Nicholas, Bernstein, Marcelle, Brown, Douglas, Sperk, Elena, Laws, Siobhan, Sütterlin, Marc, Corica, Tammy, Lundgren, Steinar, Holmes, Dennis, Vinante, Lorenzo, Bozza, Fernando, Pazos, Montserrat, Le Blanc-Onfroy, Magali, Gruber, Günther, Polkowski, Wojciech, Dedes, Konstantin J, Niewald, Marcus, Blohmer, Jens, McCready, David, Hoefer, Richard, Kelemen, Pond, Petralia, Gloria, Falzon, Mary, Joseph, David J, Tobias, Jeffrey S
مصطلحات موضوعية: RESEARCH
الوصف: Objective To determine whether risk adapted intraoperative radiotherapy, delivered as a single dose during lumpectomy, can effectively replace postoperative whole breast external beam radiotherapy for early breast cancer. Design Prospective, open label, randomised controlled clinical trial. Setting 32 centres in 10 countries in the United Kingdom, Europe, Australia, the United States, and Canada. Participants 2298 women aged 45 years and older with invasive ductal carcinoma up to 3.5 cm in size, cN0-N1, eligible for breast conservation and randomised before lumpectomy (1:1 ratio, blocks stratified by centre) to either risk adapted targeted intraoperative radiotherapy (TARGIT-IORT) or external beam radiotherapy (EBRT). Interventions Random allocation was to the EBRT arm, which consisted of a standard daily fractionated course (three to six weeks) of whole breast radiotherapy, or the TARGIT-IORT arm. TARGIT-IORT was given immediately after lumpectomy under the same anaesthetic and was the only radiotherapy for most patients (around 80%). TARGIT-IORT was supplemented by EBRT when postoperative histopathology found unsuspected higher risk factors (around 20% of patients). Main outcome measures Non-inferiority with a margin of 2.5% for the absolute difference between the five year local recurrence rates of the two arms, and long term survival outcomes. Results Between 24 March 2000 and 25 June 2012, 1140 patients were randomised to TARGIT-IORT and 1158 to EBRT. TARGIT-IORT was non-inferior to EBRT: the local recurrence risk at five year complete follow-up was 2.11% for TARGIT-IORT compared with 0.95% for EBRT (difference 1.16%, 90% confidence interval 0.32 to 1.99). In the first five years, 13 additional local recurrences were reported (24/1140 v 11/1158) but 14 fewer deaths (42/1140 v 56/1158) for TARGIT-IORT compared with EBRT. With long term follow-up (median 8.6 years, maximum 18.90 years, interquartile range 7.0-10.6) no statistically significant difference was found for local recurrence-free survival (hazard ...
وصف الملف: text/html
العلاقة: http://www.bmj.com/cgi/content/short/370/aug19_1/m2836Test; http://dx.doi.org/10.1136/bmj.m2836Test
الإتاحة: https://doi.org/10.1136/bmj.m2836Test
http://www.bmj.com/cgi/content/short/370/aug19_1/m2836Test -
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المؤلفون: Coombs, Nathan J, Coombs, Joel M, Vaidya, Uma J, Singer, Julian, Bulsara, Max, Tobias, Jeffrey S, Wenz, Frederik, Joseph, David J, Brown, Douglas A, Rainsbury, Richard, Davidson, Tim, Adamson, Douglas J A, Massarut, Samuele, Morgan, David, Potyka, Ingrid, Corica, Tammy, Falzon, Mary, Williams, Norman, Baum, Michael, Vaidya, Jayant S
المصدر: BMJ Open
مصطلحات موضوعية: Time Factors, IORT, Geographic Mapping, Breast Neoplasms, Transportation, Mastectomy, Segmental, Health Services Accessibility, State Medicine, Breast cancer, Humans, Randomized Controlled Trials as Topic, Vehicle Emissions, Air Pollutants, targeted intraoperative radiotherapy, Intraoperative Care, Research, Carbon Dioxide, Hospitals, United Kingdom, Oncology, Female, Dose Fractionation, Radiation, TARGIT, RADIOTHERAPY
الوصف: Objective To quantify the journeys and CO2 emissions if women with breast cancer are treated with risk-adapted single-dose targeted intraoperative radiotherapy (TARGIT) rather than several weeks' course of external beam whole breast radiotherapy (EBRT) treatment. Setting (1) TARGIT-A randomised clinical trial (ISRCTN34086741) which compared TARGIT with traditional EBRT and found similar breast cancer control, particularly when TARGIT was given simultaneously with lumpectomy, (2) 2 additional UK centres offering TARGIT. Participants 485 UK patients (249 TARGIT, 236 EBRT) in the prepathology stratum of TARGIT-A trial (where randomisation occurred before lumpectomy and TARGIT was delivered simultaneously with lumpectomy) for whom geographical data were available and 22 patients treated with TARGIT after completion of the TARGIT-A trial in 2 additional UK breast centres. Outcome measures The shortest total journey distance, time and CO2 emissions from home to hospital to receive all the fractions of radiotherapy. Methods Distances, time and CO2 emissions were calculated using Google Maps and assuming a fuel efficiency of 40 mpg. The groups were compared using the Student t test with unequal variance and the non-parametric Wilcoxon rank-sum (Mann-Whitney) test. Results TARGIT patients travelled significantly fewer miles: TARGIT 21 681, mean 87.1 (SE 19.1) versus EBRT 92 591, mean 392.3 (SE 30.2); had lower CO2 emissions 24.7 kg (SE 5.4) vs 111 kg (SE 8.6) and spent less time travelling: 3 h (SE 0.53) vs 14 h (SE 0.76), all p
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=pmid________::28f5db7e6dc3e310fc217b61728bf532Test
http://europepmc.org/articles/PMC4890331Test -
3دورية أكاديمية
المؤلفون: Vaidya, Jayant S, Wenz, Frederik, Bulsara, Max, Tobias, Jeffrey S, Joseph, David, Keshtgar, Mohammed, Flyger, Henrik, Massarut, Samuele, Alvarado, Michael, Saunders, Christobel, Eiermann, Wolfgang, Metaxas, Marinos, Sperk, Elena, Sutterlin, Marc, Brown, Douglas, Esserman, Laura, Roncadin, Mario, Thompson, Alastair, Dewar, John, Holtveg, Helle R, Pigorsch, Steffi, Falzon, Mary, Harris, Eleanor, Matthews, April, Brew-Graves, Chris, Potyka, Ingrid, Corica, Tammy, Williams, Norman R, Baum, Michael
المصدر: Medical Papers and Journal Articles
مصطلحات موضوعية: breast cancer, research, radiotherapy, Medicine and Health Sciences
الوصف: Background The TARGIT-A trial compared risk-adapted radiotherapy using single-dose targeted intraoperative radiotherapy (TARGIT) versus fractionated external beam radiotherapy (EBRT) for breast cancer. We report 5-year results for local recurrence and the first analysis of overall survival. Methods TARGIT-A was a randomised, non-inferiority trial. Women aged 45 years and older with invasive ductal carcinoma were enrolled and randomly assigned in a 1:1 ratio to receive TARGIT or whole-breast EBRT, with blocks stratified by centre and by timing of delivery of targeted intraoperative radiotherapy: randomisation occurred either before lumpectomy (prepathology stratum, TARGIT concurrent with lumpectomy) or after lumpectomy (postpathology stratum, TARGIT given subsequently by reopening the wound). Patients in the TARGIT group received supplemental EBRT (excluding a boost) if unforeseen adverse features were detected on final pathology, thus radiotherapy was risk-adapted. The primary outcome was absolute difference in local recurrence in the conserved breast, with a prespecified non-inferiority margin of 2·5% at 5 years; prespecified analyses included outcomes as per timing of randomisation in relation to lumpectomy. Secondary outcomes included complications and mortality. This study is registered with ClinicalTrials.gov, number NCT00983684. Findings Patients were enrolled at 33 centres in 11 countries, between March 24, 2000, and June 25, 2012. 1721 patients were randomised to TARGIT and 1730 to EBRT. Supplemental EBRT after TARGIT was necessary in 15·2% [239 of 1571] of patients who received TARGIT (21·6% prepathology, 3·6% postpathology). 3451 patients had a median follow-up of 2 years and 5 months (IQR 12–52 months), 2020 of 4 years, and 1222 of 5 years. The 5-year risk for local recurrence in the conserved breast was 3·3% (95% CI 2·1–5·1) for TARGIT versus 1·3% (0·7–2·5) for EBRT (p=0·042). TARGIT concurrently with lumpectomy (prepathology, n=2298) had much the same results as EBRT: 2·1% (1·1–4·2) versus 1·1% ...
العلاقة: https://researchonline.nd.edu.au/med_article/664Test; http://www.sciencedirect.com.ipacez.nd.edu.au/science/article/pii/S0140673613619509Test
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المؤلفون: Vaidya, Jayant S, Wenz, Frederik, Bulsara, Max, Tobias, Jeffrey S, Joseph, David, Baum, Michael
المصدر: Medical Papers and Journal Articles
مصطلحات موضوعية: breast cancer, research, radiotheraphy, response to critique, Medicine and Health Sciences
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المؤلفون: Tobias, Jeffrey S.
المصدر: eweb:176299
مصطلحات موضوعية: Consent, Informed Consent, Patients, Research, Informed Consent or Human Experimentation, Journalism / Mass Media Ethics
وصف الملف: Article
العلاقة: BMJ: British Medical Journal 1997 April 12; 314(7087): 1111- 1114; http://worldcatlibraries.org/registry/gateway?version=1.0&url_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&atitle=BMJTest's+Present+Policy+is+Wholly+Correct&title=BMJ:+British+Medical+Journal+&volume=314&issue=7087&spage=1114&date=1997-04&au=Tobias,+Jeffrey+S.; http://dx.doi.org/10.1136/bmj.314.7087.1111Test; http://hdl.handle.net/10822/903338Test
الإتاحة: https://doi.org/10.1136/bmj.314.7087.1111Test
http://hdl.handle.net/10822/903338Test
http://worldcatlibraries.org/registry/gateway?version=1.0&url_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&atitle=BMJTest's+Present+Policy+is+Wholly+Correct&title=BMJ:+British+Medical+Journal+&volume=314&issue=7087&spage=1114&date=1997-04&au=Tobias,+Jeffrey+S. -
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المؤلفون: La Puma, John, Stocking, Carol B., Rhoades, William D., Darling, Cheryl M., Ferner, R.E., Neuberger, Julia, VandenBurg, Malcolm, Dews, Ian, Tobias, Jeffrey S.
المصدر: BRL:KIE/48083
مصطلحات موضوعية: Advertising, Attitudes, Biomedical Research, Conflict of Interest, Consent, Disclosure, Drug Industry, Drugs, Doctors, Economics, Ethics, Ethics Committees, Financial Support, Human Experimentation, Incentives, Industry, Informed Consent, International Aspects, Investigators, Patient Care, Patients, Physicians, Remuneration, Research, Research Ethics, Research Ethics Committees, Research Subjects, Risk, Survey, Therapeutic Research
الوصف: Postmarketing research, often called phase IV trials, is intended to familiarise doctors and patients with newly approved drugs. La Puma and colleagues, in Chicago, studied doctors' and patients' attitudes to whether doctors should receive payment for taking part in such research. We asked for commentaries on their findings from four ethical experts, who put the study in a British context, present the views of patients, and examine some methodological assumptions.
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المؤلفون: Tobias, Jeffrey S., Souhami, Robert L.
المصدر: BRL:KIE/42231
مصطلحات موضوعية: Alternatives, Cancer, Clinical Trials, Consent, Decision Making, Diagnosis, Disclosure, Human Experimentation, Informed Consent, International Aspects, Illness, Investigators, Kindness, Paternalism, Patients, Physician Patient Relationship, Physicians, Psychological Stress, Random Selection, Research, Research Subjects, Therapeutic Research, Trust, psy, hisphilso
الوصف: After many years of experience as committed trialists and believers in the statistical and clinical value of the randomised clinical trial, we feel that uniform recommendation for full written informed consent, as outlined for example by the Royal College of Physicians, may be not only bad for clinical trials but, far more important, unnecessarily cruel to patients.We suggest that the process of informed consent should be viewed as another straightforward instance in which the clinical judgment of the doctor is paramount. Clearly, for a patient who wishes to know what underlies all aspects of decision making, there is no doubt that a full explanation should be given, together with all the necessary information about the trial. At the other extreme a distraught patient, possibly within days of diagnosis of a potentially lethal illness, may be unable to take in any but the most basic details.The counter argument will be that we are advocating a paternalistic "doctor knows best" approach. We are not. We wish to see this discussion with the patient informed by the same wisdom, judgment, and kindness which should be part of all aspects of clinical care. We believe that the ethical pressure that has put us so much on the defensive is flawed.
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المساهمون: Doyal, Len, Tobias, Jeffrey S.
المصدر: 227685.
مصطلحات موضوعية: Consent, Informed Consent, Medical Research, Research, Education for Health Care Professionals, Patient Relationships, Truth-telling, Reproduction / Reproductive Technologies, Genetics, Molecular Biology and Microbiology, Neurosciences and Mental Health Therapies, Informed Consent or Human Experimentation, International and Political Dimensions of Biology and Medicine, Journalism / Mass Media Ethics, Research on Special Populations, Research on Newborns and Minors, Acquired Immunodeficiency Syndrome or HIV Infection, edu, socio
الوصف: Contributors -- Foreword / Richard Smith -- Introduction / Len Doyal and Jeffrey S. Tobias -- Pt. I. Informed consent and medical research: a historical perspective -- Ch. 1. The Nuremberg code and the Helsinki declaration -- Ch. 2. A historical introduction to the requirement of obtaining informed consent from research participants / Baruch A Brody -- Ch. 3. Human guinea pigs and the ethics of experimentation: the BMJ's correspondent at the Nuremberg medical trial / Paul Weindling -- Ch. 4. Henry K. Beecher and Maurice Pappworth: informed consent in human experimentation and the physicians' response / Paul J. Edelson -- Ch. 5. Extracts from Pappworth and Beecher -- Introduction to Beecher's "Ethics and clinical research" / Len Doyal -- Ethics and clinical research / Henry K Beecher -- Commentary on "Ethics and clinical research" / John P Bunker -- An introduction to Pappworth's Human guinea pigs / Jeffrey S. Tobias -- Human guinea pigs / M.H. Pappworth -- Commentary on Human guinea pigs / Stephen Lock -- Ch. 6. Learning from unethical research / Paul McNeill and Naomi Pfeffer -- Pt. II. The BMJ debate: informed consent in medical research -- Ch. 7. Informed consent: the intricacies / Richard Smith -- Ch. 8. Evaluation of a stroke family care worker: results of a randomised controlled trial / Martin Dennis, Suzanne O'Rourke, Jim Slattery, Trish Staniforth, and Charles Warlow -- No consent means not treating the patient with respect (commentary) / Sheila A.M. McLean - - Why we didn't ask patients for their consent (commentary) -- Martin Dennis -- Ch. 9. Does HIV status influence the outcome of patients admitted to a surgical intensive care unit? A prospective double blind study / Satish Bhagwanjee, David J.J. Muckart, Prakash M. Jeena, Prushini Moodley -- Failing to seek patient consent to research is always wrong (commentary) / Rajendra Kale and Laxmi-Kunj -- Why we did not seek informed consent before testing patients for HIV (commentary) / Satish Bhagwanjee, David J.J. Muckart, Prakash M. Jeena, Prushini .
