369 results match your criteria: "National Health and Medical Research Council Clinical Trials Centre[Affiliation]"

Magnetic resonance imaging screening of the contralateral breast in women with newly diagnosed breast cancer: systematic review and meta-analysis of incremental cancer detection and impact on surgical management.

J Clin Oncol

November 2009

Screening and Test Evaluation Program, School of Public Health, Faculty of Medicine, and National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.

Purpose: Preoperative magnetic resonance imaging (MRI) is increasingly used for staging women with breast cancer, including screening for occult contralateral cancer. This article is a review and meta-analysis of studies reporting contralateral MRI in women with newly diagnosed invasive breast cancer.

Methods: We systematically reviewed the evidence on contralateral MRI, calculating pooled estimates for positive predictive value (PPV), true-positive:false-positive ratio (TP:FP), and incremental cancer detection rate (ICDR) over conventional imaging.

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Using the principles of randomized controlled trial design to guide test evaluation.

Med Decis Making

June 2010

National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW 2050, Australia.

The decision to use a new test should be based on evidence that it will improve patient outcomes or produce other benefits without adversely affecting patients. In principle, long-term randomized controlled trials (RCTs) of test-plus-treatment strategies offer ideal evidence of the benefits of introducing a new test relative to current best practice. However, long-term RCTs may not always be necessary.

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Duration of chemotherapy for advanced non-small-cell lung cancer: a systematic review and meta-analysis of randomized trials.

J Clin Oncol

July 2009

Sydney Cancer Center, Royal Prince Alfred Hospital, National Health and Medical Research Council Clinical Trials Centre, University of Sydney, New South Wales, Australia.

Purpose: To determine if it is preferable to extend chemotherapy beyond a standard number of cycles in patients receiving first-line chemotherapy for advanced non-small-cell lung cancer.

Methods: We searched biomedical literature databases and conference proceedings for randomized controlled trials (RCTs) comparing a defined number of cycles with continuation of the same chemotherapy until disease progression, a larger defined number of cycles of identical chemotherapy, and a defined number of cycles of identical initial chemotherapy followed by additional cycles of an alternative chemotherapy. Meta-analysis was performed using the fixed effect model.

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Background: Amputations in people with type 2 diabetes mellitus substantially impair their quality of life and impose high costs on health-care systems. Our aim was to assess the effect of fenofibrate on amputation events in a large cohort of patients with type 2 diabetes.

Methods: In the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study, 9795 patients aged 50-75 years with type 2 diabetes were randomly assigned by computer-generated randomisation sequence to receive fenofibrate 200 mg per day (n=4895) or matching placebo (n=4900) for 5 years' duration.

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Breast cancer risk and hormone receptor status in older women by parity, age of first birth, and breastfeeding: a case-control study.

Cancer Epidemiol Biomarkers Prev

July 2008

National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.

Background: Early age at first birth and multiparity reduce the risk of estrogen receptor-progesterone receptor (ERPR)-positive breast cancer, whereas breastfeeding reduces the risk of both ERPR-positive and ERPR-negative cancers.

Methods: We used multivariable logistic regression analysis to investigate whether age at first birth (<25 or > or =25 years) and breastfeeding (ever/never) modify the long-term effect of parity on risk of ERPR-positive and ERPR-negative cancer using 1,457 incident breast cancer cases and 1,455 controls ages > or =55 years who participated in the Women's Contraceptive and Reproductive Experiences Study.

Results: Women who gave birth before age 25 years had a 36% reduced risk of breast cancer compared with nulligravida that was not observed for women who started their families at an older age (P(heterogeneity) = 0.

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Background & Aims: Computerized tomography colonography (CTC) is a highly accurate test for the detection of colorectal polyps and cancers and has been proposed as a potential alternative to colonoscopy. Bowel cancer screening using fecal occult blood testing (FOBT) and follow-up diagnostic colonoscopy is an effective intervention that currently is being implemented in screening programs internationally. Because of high false-positive rates for FOBT, concerns have been raised about patient uptake and access to colonoscopy services.

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A systematic review of the effectiveness of magnetic resonance imaging (MRI) as an addition to mammography and ultrasound in screening young women at high risk of breast cancer.

Eur J Cancer

September 2007

National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Level 5, Building F, 88 Mallett Street, Locked Bag 77, Camperdown, New South Wales 2050, Australia.

Breast magnetic resonance imaging (MRI) has been proposed as an additional screening test for young women at high risk of breast cancer in whom mammography alone has poor sensitivity. We conducted a systematic review to assess the effectiveness of adding MRI to mammography with or without breast ultrasound and clinical breast examination (CBE) in screening this population. We found consistent evidence in 5 studies that adding MRI provides a highly sensitive screening strategy (sensitivity range: 93-100%) compared to mammography alone (25-59%) or mammography plus ultrasound+/-CBE (49-67%).

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Evidence-based recommendations concerning how to discuss dying, life expectancy, and likely future symptoms with patients with a limited life expectancy and their families are lacking. The aim of this systematic review was to review studies regarding prognostic/end-of-life communication with adult patients in the advanced stages of a life-limiting illness and their caregivers. Relevant studies meeting the inclusion criteria were identified by searching computerized databases up to November 2004.

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Background: Resectable oesophageal cancer is often treated with surgery alone or with preoperative (neoadjuvant) chemoradiotherapy or chemotherapy. We aimed to clarify the benefits of neoadjuvant chemoradiotherapy or chemotherapy versus surgery alone by a meta-analysis of randomised trial data.

Methods: Eligible trials were identified first from earlier published meta-analyses and systematic reviews.

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Interventions for prevention of post-operative atrial fibrillation and its complications after cardiac surgery: a meta-analysis.

Eur Heart J

December 2006

National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Level 5, Building F, 88 Mallett Street, Camperdown 2050, Sydney, NSW, Australia.

Aims: Atrial fibrillation (AF) is the most common complication after cardiac surgery. We aimed to evaluate, by meta-analysis, all randomized trials testing interventions for preventing AF.

Methods And Results: Ninety-four trials of prevention of post-operative AF were identified, by standard search methods, and analysed by standard meta-analysis techniques.

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When is measuring sensitivity and specificity sufficient to evaluate a diagnostic test, and when do we need randomized trials?

Ann Intern Med

June 2006

National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Camperdown, NSW, Australia.

The clinical value of using a new diagnostic test depends on whether it improves patient outcomes beyond the outcomes achieved using an old diagnostic test. When can studies of diagnostic test accuracy provide sufficient information to infer clinical value, and when do clinicians need to wait for results from randomized trials? The authors argue that accuracy studies suffice if a new diagnostic test is safer or more specific than, but of similar sensitivity to, an old test. However, if a new test is more sensitive than an old test, it leads to the detection of extra cases of disease.

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Background: Postmastectomy radiation therapy reduces locoregional recurrence among women with operable breast cancer, but whether it improves survival has been controversial. We reanalyzed the results from 36 unconfounded trials (i.e.

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A systematic review and economic analysis of drug-eluting coronary stents available in Australia.

Med J Aust

November 2005

National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, NSW 2050, Australia.

Objectives: To compare the safety, effectiveness and cost-effectiveness of drug-eluting coronary stents used in Australia with bare-metal stents and determine whether the benefits are greater for high-risk subgroups.

Data Sources: MEDLINE, Pre-Medline, EMBASE, Current Contents, CINAHL and the Cochrane Library database were searched to identify eligible randomised controlled trials and systematic reviews published in English between January 1966 and June 2004.

Study Selection: Seven randomised controlled trials that assessed polymer-based paclitaxel- or sirolimus-eluting stents versus bare-metal stents in patients with coronary atherosclerosis and reported on stent thrombosis, mortality, myocardial infarction, coronary artery bypass grafting or target lesion revascularisation.

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Medical malpractice litigation is increasing. Delay in diagnosis is the commonest basis for litigation involving the treatment of breast cancer. When delay in diagnosis has occurred, any losses for which a plaintiff seeks compensation require estimates to be made of any change in prognosis over the period of the delay relative to the extent of disease found when treatment is finally undertaken.

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Guidelines for the design of clinical trials with longitudinal outcomes.

Control Clin Trials

June 2002

National Health and Medical Research Council Clinical Trials Centre, Mallett Street Campus, University of Sydney, Syndey, Australia.

A common objective of longitudinal clinical trials is to compare rates of change in a continuous response variable between two groups. The power realized for such a study is a function of both the number of people recruited and the planned number of measurements for each participant. By varying these two quantities in opposite directions, power can be kept at the desired level.

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Background: The Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) trial showed that pravastatin significantly reduced mortality and coronary heart disease (CHD) events in 9014 patients with known CHD and total cholesterol 4.0 to 7.0 mmol/L at baseline.

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Patient preferences for adjuvant chemotherapy of early breast cancer: how much benefit is needed?

J Natl Cancer Inst Monogr

June 2002

R. J. Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, New South Wales 2006, Australia.

Adjuvant chemotherapy for early-stage breast cancer has been shown to delay recurrence and improve survival. However, the benefits are modest and must be balanced against the adverse treatment effects. We assessed the size of the survival benefit needed to justify the toxicity of chemotherapy, based on the preferences of women who had previously received adjuvant cyclophosphamide, methotrexate, and 5-fluorouracil (CMF).

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Publication bias: evidence of delayed publication in a cohort study of clinical research projects.

BMJ

September 1997

National Health and Medical Research Council Clinical Trials Centre, University of Sydney, NSW, Australia.

Objectives: To determine the extent to which publication is influenced by study outcome.

Design: A cohort of studies submitted to a hospital ethics committee over 10 years were examined retrospectively by reviewing the protocols and by questionnaire. The primary method of analysis was Cox's proportional hazards model.

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