conflicts of interest in clinical trials

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Ngày tải lên: 30/03/2014, 12:21

... analyses in such a large sample The primary outcome of the study was a comparison of aspirin versus streptokinase for prevention of myocardial infarction, with a finding in favor of aspirin In subgroup ... “Since the investigator can describe only to a limited extent the kinds of participants in whom an intervention was evaluated, a leap of faith is always required when applying any study findings ... confirmatory, of any hypothesis) Clinical example: olanzapine prophylaxis of bipolar disorder In an RCT of olanzapine added to standard mood stabilizers (divalproex or lithium) for prevention of mood...

Ngày tải lên: 01/11/2013, 11:20

... instrument for assessing symptom severity and response to treatment in clinical trials of patients with GERD 10 11 12 Competing interests The authors declare that they have no competing interests 13 ... Measurement of health status Ascertaining the minimal clinically important difference Control Clin Trials 1989, 10:407-415 Juniper EF, Guyatt GH, Willan A, Griffith LE: Determining a minimal important ... evaluation of instruments includes item selection and multitrait scaling, internal consistency of items that combine into a dimension [17], as well as confirmation of convergent and/or discriminant...

Ngày tải lên: 18/06/2014, 22:20

... variety of antidepressants, including tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin-norepinephrine reuptake inhibitors [5,6] The trials in this analysis all included ... Montgomery-sberg Depression Rating Scale, the Hamilton Depression Rating Scale and the Clinical Global Impressions Rating Scale in antidepressant clinical trials Int Clin Psychopharmacol 2002, 17:281-285 ... Relative sensitivity of the Montgomery-sberg Depression Rating Scale, the Hamilton Depression Rating Scale and the Clinical Global Impressions Rating Scale in antidepressant clinical trials: a replication...

Ngày tải lên: 08/08/2014, 23:21

... gastrointestinal adverse events, we included an overall measure of gastrointestinal tolerability as well as individual gastrointestinal adverse events of nausea, vomiting, abdominal pain, dyspepsia, ... medications, than in clinical trials Using company clinical trial reports removes some of the problems of selective reporting in published papers due to strict word limitations Here the company clinical ... 200 mg daily In trials of 12 weeks' duration, 46% of doses were 200 mg and 46% were of 400 mg daily In trials of 24 weeks or longer, 92% of doses were of 800 mg daily Longerlasting trials used...

Ngày tải lên: 09/08/2014, 06:22

Ngày tải lên: 09/08/2014, 07:20

... understanding of information related to clinical trials The appreciation of children and adolescents and their parents of what a clinical trial involved and their reasoning about participation in a clinical ... need further information As the aim cannot be to obtain informed consent in a legal meaning from legal minors or young children, the primary target of clinical investigators in clinical studies ... information about clinical trials in children by structuring the information process, additional or alternative methods of information about the nature and probable consequences of clinical trials...

Ngày tải lên: 13/08/2014, 18:21

... significant treatment effect Inefficient analysis of trials may contribute this the failure • Dichotomous analysis of an ordinal outcome scale in clinical trials results in loss of information Previous ... resulted in an even larger Wald statistic of 3.69 (P = 0.0002), indicating a 2.56-fold increase in information density Discussion Analysis of the MRC CRASH trial data showed that ordinal analysis of ... ordinal outcome analysis that were investigated in the present study resulted in substantial power increase Therefore, we strongly recommend incorporating ordinal methods in the analysis of future...

Ngày tải lên: 14/08/2014, 08:21

... Entities Involved in Compendia Development and their Potential Conflicts of Interest 2.4 Examples of Conflict of Interest in the Development of Clinical Practice Guidelines ... Conflict of interest in selection of indications and evidence .24 4.1.4 Conflict of interest in interpretation of evidence .26 4.2 Compendia Development, Review Processes, and Conflict -of- Interest ... Conflict of interest in the process of making study data available; 3) Conflict of interest leading to biased selection of indications to review, and of evidence sources; and, 4) Bias in the interpretation...

Ngày tải lên: 09/03/2014, 00:20

... perverse incentive, indeed In "Conflicts of Interest in Engineering," Neil Luebke describes the conflict -of- interest rules under which engineers typically work, a combination of their own professional ... appearance of conflict of interest Appearances are hard to manage In "Conflict of Interest as Risk Management," Kevin INTRODUCTION McMunigal treats conflicts of interest as a species of "perverse incentives." ... strategy for avoiding all conflict of interest, but it is a strategy making the concept of conflict of interest uninteresting We must worry about conflict of interest only when having two or more...

Ngày tải lên: 16/03/2014, 05:20

... complaints of pain in other regions of the trunk A model that divides the spine into more segments, while not reflecting the total number of vertebrae in the spine, would bring the study of the internal ... adjusted by including/excluding weight plates like those used in strength training 6 Applications of EMG in Clinical and Sports Medicine Each participant performed two series of ten repetitions of the ... affect the spine Due to the invasive nature of measuring these internal loads, models employing indirect means of estimating the loads that act on the lumbar region of the spine during lifting activities...

Ngày tải lên: 27/06/2014, 16:20

... tolerance occurs in 40% of siblings and in 30% of the offspring of an affected individual Despite the fact that diabetes affects 5% of the population and exhibits a high degree of heritability, ... seeing other specialists The internist has an important role in educating patients about the indications, benefits, risks, and limitations of genetic testing in the management of a number of ... also influence the severity of infirmity, effect of treatment, and progression of disease The primary care clinician is now faced with the role of recognizing and counseling patients...

Ngày tải lên: 07/07/2014, 01:20

... underscoring the importance of family history for these prevalent disorders Pending further advances in genetic testing, the key to assessing the inherited risk for common adult-onset diseases rests in ... presence or absence of nonhereditary risk factors among those affected with diseases, and the finding of multiple diseases in an individual patient For instance, a woman with a history of both colon ... disease-causing mutations are more prevalent in certain ethnic groups For instance, >2% of the Ashkenazi population carry one of three specific mutations in the BRCA1 or BRCA2 genes The prevalence of...

Ngày tải lên: 07/07/2014, 01:20

... before initiating genetic testing is to ensure that the correct clinical diagnosis has been made, whether based on family history, characteristic physical findings, or biochemical testing Careful clinical ... breast cancer, representing another confounding variable in the pedigree analysis Some of the aforementioned features of the family history are illustrated in Fig 64-1 In this example, the proband, ... history of breast and ovarian cancer on the paternal side of her family The early age of onset, as well as the co-occurrence of breast and ovarian cancer in this family, suggests the possibility of...

Ngày tải lên: 07/07/2014, 01:20

... established disease, genetic testing for susceptibility to chronic disease is being increasingly integrated into the practice of medicine In most cases, however, the discovery of disease-associated genes ... provided informed consent In the majority of cases, genetic testing should be offered only to individuals with a suggestive personal or family medical history or in the context of a clinical trial ... immunohistochemistry) The determination of DNA sequence alterations relies heavily on the use of polymerase chain reaction (PCR), which allows rapid amplification and analysis of the gene of interest In addition,...

Ngày tải lên: 07/07/2014, 01:20

... notions of their personal likelihood of disease in preparing pretest educational strategies Often, patients harbor unwarranted fear or denial of their likelihood of genetic risk Genetic testing has ... concern that testing during childhood violates a child's right to make an informed decision regarding testing upon reaching adulthood On the other hand, testing should be offered in childhood for disorders ... mechanics of testing Most molecular testing for hereditary disease involves DNA-based analysis of peripheral blood In the majority of circumstances, test results should be given only to the individual,...

Ngày tải lên: 07/07/2014, 01:20

... Genetic Counseling and Education Genetic counseling should be distinguished from genetic testing and screening, even though genetic counselors are often involved in issues related to testing Genetic ... expression of disease; Address medical management issues; Assist in determining the role of genetic testing for the individual and family; Ensure that the patient is aware of the indications, ... prevention Finally, patients should understand the natural history of the disease as well as the potential options for intervention, including screening, prevention, and in certain circumstances—...

Ngày tải lên: 07/07/2014, 01:20

... Gastrointestinal Familial AR MEFV Mediterranean fever Hemochromatosis Pulmonary Colchicine treatment AR HFE Phlebotomy α1 Antitrypsin AR PI deficiency Avoidance of smoking Avoidance occupational of ... Familial Parkinson AD disease SNCA, PARK2 Amantadine, anticholinergics, levodopa, monoamine oxidase B inhibitors Wilson disease AR ATP7B Zinc, trientene Abbreviations: AD, autosomal dominant; AR, ... treatment (phlebotomy) before the development of organ damage Table 64-2 Examples of Genetic Testing and Possible Interventions Genetic Disorder Inherita Genes Interventions AD MSH2, Early endoscopic...

Ngày tải lên: 07/07/2014, 01:20

... intensive clinical screening, as it remains very challenging to predict disease penetrance, expression, or clinical course Although genetic diagnosis of these and other disorders is only beginning ... used in the clinical setting, predictive testing holds the promise of allowing earlier and more targeted interventions that can reduce morbidity and mortality We can expect the availability of ... permits individualized drug therapy, resulting in improved treatment outcomes, reduced toxicities, and more cost-effective pharmaceutical care Examples include succinylcholine sensitivity, thiopurine...

Ngày tải lên: 07/07/2014, 01:20

... rheumatoid arthritis clinical trials of the Osteoarthritis Research Society International) definition of Greater discrimination between pain therapies at higher levels of pain relief has been shown ... higher doses of pregabalin [16] Proportions were even lower in breakthrough pain treatment [16] In acute pain trials in standardised pain models, commonly used drug and dose combinations typically ... sought to use data from a single clinical trial in osteoarthritis to explore whether a more informative interpretation of osteoarthritis trials might be obtained by using dichotomous responder...

Ngày tải lên: 09/08/2014, 10:23