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21. A Prospective Validation Study of a Rapid Point-of-Care Breath Test for Breast Cancer

may be associated with an increased risk of radiation-induced breast cancer, as well as with overdiagnosis and overtreatment. Many women decide not to take the test even when it is readily available, and screening mammography may be underutilized because of fear of pain and radiation exposure, ethnicity, poverty, and level of education. Breath tests - a new diagnostic tool: Abnormal volatile organic compounds (VOCs) in breath have been identified in breast cancer. Breath VOC biomarkers have been

2016 Clinical Trials

22. Lung Cancer Screening Decisions

for those with 30 pack years or more of smoking or who quit less than 15 years ago. Evidence clearly delineates both the benefits (mortality reduction) and harms (false positives, follow-up testing, risk of invasive testing, and risk of overdiagnosis) of lung cancer screening. Preliminary data from an HSR&D pilot grant finds that some Veterans are highly reluctant to enter the care pathway associated with lung cancer screening due to its potential harms. Additional preliminary data using Best Worst

2016 Clinical Trials

23. Italian Lung Cancer Screening Trial (ITALUNG)

: overall mortality [ Time Frame: till 8 years or more of average follow up since randomization ] All subjects were followed up using the Tuscany Region Registry of causes of death Incidence excess/overdiagnosis [ Time Frame: till 8 years or more of average follow up from randomization ] All subjects were followed up using the Tuscany Region Registry of Cancer Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision

2016 Clinical Trials

24. Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS

(AS) compared to guideline concordant care (GCC) in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ (DCIS) using an AS approach does not yield inferior cancer or quality of life outcomes compared to GCC. Condition or disease Intervention/treatment Phase DCIS Ductal Carcinoma in Situ Other: Guideline Concordant Care Other: Active Surveillance Not Applicable Detailed Description: Overdiagnosis (...) and overtreatment resulting from mammographic screening have been estimated to be as high as 1 in 4 patients diagnosed with breast cancer although the absence of standard definitions for measuring overdiagnosis has led to much uncertainty around this estimate. The national health care expenditure resulting from false positive mammograms and breast cancer overdiagnosis has been estimated to approach $4 billion annually. There is general consensus that much of this burden derives from the treatment of DCIS

2016 Clinical Trials

25. The Andromeda Study.Predictive Value of Combined Criteria to Tailor Breast Cancer Screening.

the screening harms (false positive results, overdiagnosis, radiation exposure, discomfort caused by the test itself, etc.) The ANDROMEDA Study aims at creating the possibility to customize the screening paths through a combined analysis of the above mentioned risk factors. Women consenting to be involved in the study will be asked to provide information on their lifestyle habits and reproductive history. Furthermore a blood sample will be collected for further bio-molecular analysis purposes. Condition

2015 Clinical Trials

26. Women Informed to Screen Depending on Measures of Risk (Wisdom Study)

are cancer diagnoses for growths that might never come to clinical attention if left alone (called "overdiagnosis"). This can lead to unnecessary treatment. Even more concerning is evidence that up to 20% of breast cancers detected today may fall into the category of "overdiagnosis." This proposal compares annual screening with a risk-based breast cancer screening schedule, based upon each woman's personal risk of breast cancer. The investigators have designed the study to be inclusive of all, so

2015 Clinical Trials

27. Tomosynthesis Versus Digital Mammography in a Population-based Screening Program

) are needed to confirm these promising results. Furthermore, potential side effects of DBT in the screening setting have to be properly evaluated. In particular, the major concern is about overdiagnosis and its consequences; overdiagnosis refers to the detection of cancers at screening, which would not have become clinically apparent in the woman's lifetime. This RCT was designed to compare benefits and harms of DBT in a population-based screening program with conventional DM. The primary outcome (...) round all participants will be invited to DM only. Interval cancers and advanced cancers screen-detected at the next round will be recorded. Pathological and biological parameters of screen-detected cancers (e.g, stage, grading, hormone receptors, HER2) in both screening arms will be measured to investigate overdiagnosis. With a sample size of 23,000 and 69,000 women in the DBT and DM arm respectively, the investigators will be able to observe a significant decrease in interval cancers and advanced

2015 Clinical Trials

28. Trial of a Mammography Decision Aid for Women Aged 75 and Older

, data suggest that women need around 10 year life expectancy to have a chance at a mortality benefit from being screened with mammography. Meanwhile, there are immediate harms to screening older women including: pain, anxiety, complications from tests after a false positive mammogram (e.g., breast biopsy), and overdiagnosis (finding tumors that otherwise would never have caused symptoms in one's lifetime). Overdiagnosis is particularly concerning since some older women experience significant

2014 Clinical Trials

29. FDG-PET/CT in Evaluation of Cytological Indeterminate Thyroid Nodules to Prevent Unnecessary Surgery (EfFECTS)

of the head and neck lead to overdiagnosis in non-thyroidal incidental findings. Overall and Disease Free Survival [ Time Frame: 12 months after inclusion ] SO1f: To determine the short-term overall and disease free survival in both study arms. FDG-PET/CT Implementation-hampering Factors [ Time Frame: 12 months after inclusion ] SO1g: To determine which factors hamper implementation of this modality for this indication (structured interviews). Fraction of Patients being operated despite negative FDG-PET

2014 Clinical Trials

30. Cervical Cancer Prevention: From DNA to mRNA?

+ in the five years following a HPV DNA positive test and mRNA or p16 negative. Measuring the potential reduction of overdiagnosis of using mRNA or p16 test instead of DNA, with direct sending in colposcopy Measuring the reduction of overdiagnosis of cytological triage or triage with mRNA or p16 compared to the direct sending in colposcopy in women with HPV DNA test positive. Secondary objectives are: to assess the feasibility of mRNA testing in primary screening to validate the sample techniques (...) rates in the two arms in women with p16 or mRNA negative [ Time Frame: 1 year ] proportion of CIN2+, HPV DNA positive and p16 or mRNA negative, which regress in a year comparison between CIN2+ detection rates in the two arms in women with negative cytology [ Time Frame: 1 year ] measure of how much the cytological triage can reduce overdiagnosis compared to HPV DNA with direct sending to colposcopy comparison between CIN2+ detection rate in the two arms in women with p16 or mRNA positive [ Time

2013 Clinical Trials

31. Contrast-enhanced MR Imaging as a Breast Cancer Screening in Women at Intermediate Risk

compared to the conventional arm (overdiagnosis) after 10 years of follow up [ Time Frame: 10 years ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table

2013 Clinical Trials

32. A Cluster-randomised Trial of Interventions to Improve Antimalarial Prescribing With Malaria Tests

, 2014 Sponsor: London School of Hygiene and Tropical Medicine Collaborators: Kilimanjaro Christian Medical Centre, Tanzania Ministry of Health, Tanzania Information provided by (Responsible Party): London School of Hygiene and Tropical Medicine Study Details Study Description Go to Brief Summary: Background. Overdiagnosis of malaria is widespread in health facilities throughout Africa, a situation that is unsustainable given the relatively high cost of artemisinin combination therapy (ACTs) compared (...) into primary care health facilities in Tanzania starting in 2009. The high accuracy of current rapid diagnostic tests (RDTs) provides the potential for a cost-effective solution to the problem of malaria overdiagnosis. However, RDTs with revised guidelines to restrict malaria diagnoses to RDT-positive patients have been unsuccessful unless accompanied by unsustainable levels of supervision and training. Primary objective. To conduct a trial of interventions directed at prescribers or prescribers

2011 Clinical Trials

33. Pulmonary Function, Chronic Obstructive Pulmonary Disease (COPD) Prevalence, and Systemic Inflammation in Chronic Heart Failure With or Without COPD

with chronic heart failure (CHF) and to determine which of these pulmonary abnormalities prevail and to what extent. To determine the prevalence, underdiagnosis, and overdiagnosis of chronic obstructive pulmonary disease (COPD) as determined by spirometry and according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria in patients with CHF. To investigate the presence of systemic inflammation, as measured by inflammatory parameters (leukocytes, platelets, high sensitivity CRP (...) . The reported prevalence rates of COPD range from 9 to 41% in European cohorts and from 11 to 52% in North American patients with heart failure. The purpose of this study was to determine the prevalence, underdiagnosis, and overdiagnosis of COPD as determined by spirometry and according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria in patients with CHF. There is abundant evidence of increased systemic inflammation in both CHF and COPD and it is remarkable to observe

2011 Clinical Trials

34. Reducing Inappropriate Antibiotic Prescribing by Primary Care Clinicians

prescribing is the result of multiple factors that include difficulty in distinguishing a benign, self-limited viral infection from a more serious bacterial infection; overdiagnosis of a bacterial infection in cases where there is clinical uncertainty as to the true nature of the illness; and constraints on the time available for clinicians to explain to patients the nature of the illness and the reasons an antibiotic is not indicated. The focus of this proposal will be to compare the impact of clinical

2009 Clinical Trials

35. Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Cancer Screening

overdiagnosis or a protective effect. Methods: A total of 12527 women, aged 32-38, attending population-based invitational screening in Sweden were randomized 1:1 to HPV test and cytology (intervention arm) or cytology only (control arm). HPV-positive women were invited for a second HPV test at least one year later and women with type-specific persistent infections were then invited to colposcopy. A similar number of random double-blinded procedures are performed in the control arm. Women are followed

2007 Clinical Trials

Ongoing trials

Ongoing clinical trails via In addition to ongoing trials it also includes completed trials as there is often a lag between a trial finishing and publication.