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Fraud clinical

Adam Steventon, Sarwat I Chaudhry, Zhenqiu Lin, Jennifer A Mattera, Harlan M Krumholz
BACKGROUND: Since clinical management of heart failure relies on weights that are self-reported by the patient, errors in reporting will negatively impact the ability of health care professionals to offer timely and effective preventive care. Errors might often result from rounding, or more generally from individual preferences for numbers ending in certain digits, such as 0 or 5. We apply fraud detection methods to assess preferences for numbers ending in these digits in order to inform medical decision making...
April 18, 2017: BMC Medical Informatics and Decision Making
Rutger M van den Bor, Petrus Wj Vaessen, Bas J Oosterman, Nicolaas Pa Zuithoff, Diederick E Grobbee, Kit Cb Roes
OBJECTIVE: Central monitoring of multi-center clinical trials becomes an ever more feasible quality assurance tool, in particular for the detection of data fabrication. More widespread application, across both industry-sponsored as well as academic clinical trials, requires central monitoring methodologies that are both effective and relatively simple in implementation. STUDY DESIGN AND SETTING: We describe a computationally simple fraud detection procedure intended to be applied repeatedly and (semi-)automatically to accumulating baseline data, to detect data fabrication in multi-center trials as early as possible...
April 12, 2017: Journal of Clinical Epidemiology
Stephanie Cape, Rafiq Islam, Corey Nehls, John Allinson, Afshin Safavi, Patrick Bennett, James Hulse, Chris Beaver, Masood Khan, Shane Karnik, Maria Cruz Caturla, Steve Lowes, Adriana Iordachescu, Luigi Silvestro, Rabab Tayyem, Ron Shoup, Stephanie Mowery, Anahita Keyhani, Andrea Wakefield, Yinghe Li, Jennifer Zimmer, Javier Torres, Philippe Couerbe, Ardeshir Khadang, James Bourdage, Nicola Hughes, Kayode Awaiye, Brent Matthews, Saadya Fatmi, Rhonda Johnson, Christina Satterwhite, Mathilde Yu, Jenny Lin, Laura Cojocaru, Michele Fiscella, Eric Thomas, Kai Kurylak, John Kamerud, Zhongping John Lin, Wei Garofolo, Natasha Savoie, Mike Buonarati, Nadine Boudreau, Clark Williard, Yansheng Liu, Dominic Warrino, Prashant Kale, Neil Adcock, Radha Shekar, Edward O'Connor, Hanna Ritzen, Christina Sanchez, Roger Hayes, Mohammed Bouhajib, Simona Rizea Savu, Bruce Stouffer, Edward Tabler, Jing Tu, Chad Briscoe, Barry van der Strate, Paul Rhyne, Phyllis Conliffe, Ira DuBey, Jim Yamashita, Daniel Tang, Elizabeth Groeber, Jenifer Vija, Michele Malone, Mohamed Osman
The 10th Global CRO Council (GCC) Closed Forum was held in Orlando, FL, USA on 18 April 2016. In attendance were decision makers from international CRO member companies offering bioanalytical services. The objective of this meeting was for GCC members to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at this closed forum included reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, biomarker assay validation, processed batch acceptance criteria, electronic laboratory notebooks and data integrity, Health Canada's Notice regarding replicates in matrix stability evaluations, critical reagents and regulatory approaches to counteract fraud...
March 24, 2017: Bioanalysis
Matthew A Varacallo, Michael Wolf, Martin J Herman
BACKGROUND: Most residency programs still lack formal education and training on the basic clinical documentation and coding principles. Today's physicians are continuously being held to increasing standards for correct coding and documentation, yet little has changed in the residency training curricula to keep pace with these increasing standards. Although there are many barriers to implementing these topics formally, the main concern has been the lack of time and resources. Thus, simple models may have the best chance for success at widespread implementation...
February 28, 2017: Journal of Surgical Education
Alan Lyles
Pharmacy benefit management companies (PBMs) perform functions in the US market-based healthcare system that may be performed by public agencies or quasi-public institutions in other nations. By aggregating lives covered under their many individual contracts with payers, PBMs have formidable negotiating power. They influence pharmaceutical insurance coverage, design the terms of coverage in a plan's drug benefit, and create competition among providers for inclusion in a plan's network. PBMs have, through intermediation, the potential to secure lower drug prices and to improve rational prescribing...
May 2017: PharmacoEconomics
Clydette Powell, Kirsten Dickins, Hanni Stoklosa
Some 21 million adults and children are labor-trafficked or sex-trafficked through force, fraud, or coercion. In recognition of the interface between trafficking victims and the healthcare setting, over the last 10 years there has been a notable increase in training of health care professionals (HCPs) on human trafficking (HT) and its health implications. Many organizations have developed curricula and offered training in various clinical settings. However, methods and content of this education on trafficking vary widely, and there is little evaluation of the impact of the training...
2017: Medical Education Online
Nariakira Moriyama
Recently, the Ministry of Health, Labor and Welfare estimated the prevalence rate of gambling disorder to be 4.8 percent of the population. This rate is outstandingly higher than other countries with prevalence rates between 0.25 and 2.0 percent. It is also estimated that no fewer than 5 million Japanese suffer from the disease. In the last two years, 100 new patients visited the author's clinic. On an average, they started gambling at the age of 19.7 years, and incurring debt at the age of 25.8 years. They first visited the clinic at an average age of 38...
October 2016: Brain and Nerve, Shinkei Kenkyƫ No Shinpo
Valisha D Price, Barbara A Swanson, Briana J Jegier, Janice Phillips, Kathryn Swartout, Louis Fogg
The U.S. Marshals Service (USMS) prisoner population is diverse and includes immigration violators, fugitives that have evaded apprehension, perpetrators of Medicaid fraud, and parole and probation violators. Unlike state and local jails, the USMS has numerous housing options for its prisoners. Given the unique characteristics, federal prisoners' quality of care, and subsequent clinical outcomes, may differ from those of state and local inmates. However, little is known about hospitalization rates and length of stay for HIV-positive USMS prisoners...
October 2016: Journal of Correctional Health Care
Rakhal Gaitonde, Andrew D Oxman, Peter O Okebukola, Gabriel Rada
BACKGROUND: Corruption is the abuse or complicity in abuse, of public or private position, power or authority to benefit oneself, a group, an organisation or others close to oneself; where the benefits may be financial, material or non-material. It is wide-spread in the health sector and represents a major problem. OBJECTIVES: Our primary objective was to systematically summarise empirical evidence of the effects of strategies to reduce corruption in the health sector...
August 16, 2016: Cochrane Database of Systematic Reviews
Linda Squiers, Derick Brown, Sarah Parvanta, Suzanne Dolina, Bridget Kelly, Jill Dever, Brian G Southwell, Amy Sanders, Erik Augustson
BACKGROUND: Text messaging (short message service, SMS) has been shown to be effective in delivering interventions for various diseases and health conditions, including smoking cessation. While there are many published studies regarding smoking cessation text messaging interventions, most do not provide details about the study's operational methods. As a result, there is a gap in our understanding of how best to design studies of smoking cessation text messaging programs. OBJECTIVE: The purpose of this paper is to detail the operational methods used to conduct a randomized trial comparing three different versions of the National Cancer Institute's SmokefreeText (SFTXT) program, designed for smokers 18 to 29 years of age...
June 27, 2016: JMIR Research Protocols
Mathieu Guillame-Bert, Artur Dubrawski, Donghan Wang, Marilyn Hravnak, Gilles Clermont, Michael R Pinsky
Inductive machine learning, and in particular extraction of association rules from data, has been successfully used in multiple application domains, such as market basket analysis, disease prognosis, fraud detection, and protein sequencing. The appeal of rule extraction techniques stems from their ability to handle intricate problems yet produce models based on rules that can be comprehended by humans, and are therefore more transparent. Human comprehension is a factor that may improve adoption and use of data-driven decision support systems clinically via face validity...
January 2017: Journal of the American Medical Informatics Association: JAMIA
Phil Wiffen, Andrew Moore
This paper describes the development of evidence based methods in pain medicine since the 1980s at the Pain Research Department of the Nuffield Department of Clinical Neurosciences, Oxford University. Pain medicine can be said to have led the way in terms of developing registers of randomized controlled trials (RCTs) and in developing appropriate methodology for assessing clinical trials and developing metanalytical techniques. This paper tells the story of that development which occurred in conjunction with the development of the Cochrane Collaboration...
July 2016: International Journal of Clinical Pharmacology and Therapeutics
Jens Lykkesfeldt
In recent years, several online tools have appeared capable of identifying potential plagiarism in science. While such tools may help to maintain or even increase the originality and ethical quality of the scientific literature, no apparent consensus exists among editors on the degree of plagiarism or self-plagiarism necessary to reject or retract manuscripts. In this study, two entire volumes of published original papers and reviews from Basic & Clinical Pharmacology & Toxicology were retrospectively scanned for similarity in anonymized form using iThenticate software to explore measures to predictively identify true plagiarism and self-plagiarism and to potentially provide guidelines for future screening of incoming manuscripts...
August 2016: Basic & Clinical Pharmacology & Toxicology
Man K Chan, Jason D Cooper, Sabine Bahn
Substantial strides have been made in the field of biomarker research for mental illnesses over the past few decades. However, no US FDA-cleared blood-based biomarker tests have been translated into routine clinical practice. Here, we review the challenges associated with commercialisation of research findings and discuss how these challenges can impede scientific impact and progress. Overall evidence indicates that a lack of research funding and poor reproducibility of findings were the most important obstacles to commercialization of biomarker tests...
December 2015: Trends in Biotechnology
M J Walker, D T Burns, C T Elliott, M H Gowland, E N Clare Mills
Food allergy is an increasing problem for those affected, their families or carers, the food industry and for regulators. The food supply chain is highly vulnerable to fraud involving food allergens, risking fatalities and severe reputational damage to the food industry. Many facets are being pursued to ameliorate the difficulties including better food labelling and the concept of thresholds of elicitation of allergy symptoms as risk management tools. These efforts depend to a high degree on the ability reliably to detect and quantify food allergens; yet all current analytical approaches exhibit severe deficiencies that jeopardise accurate results being produced particularly in terms of the risks of false positive and false negative reporting...
January 7, 2016: Analyst
Patrick O Myers
No abstract text is available yet for this article.
November 2015: Annals of Thoracic Surgery
Aaron S Kesselheim, Michael S Sinha, Steven Joffe
Although insider trading is illegal, recent high-profile cases have involved physicians and scientists who are part of corporate governance or who have access to information about clinical trials of investigational products. Insider trading occurs when a person in possession of information that might affect the share price of a company's stock uses that information to buy or sell securities--or supplies that information to others who buy or sell--when the person is expected to keep such information confidential...
December 2015: JAMA Internal Medicine
Stephen L George
The disclosure of cases of research misconduct in clinical trials, conventionally defined as fabrication, falsification or plagiarism, has been a disturbingly common phenomenon in recent years. Such cases can potentially harm patients enrolled on the trials in question or patients treated based on the results of those trials and can seriously undermine the scientific and public trust in the validity of clinical trial results. Here, I review what is known about the prevalence of research misconduct in general and the contributing or causal factors leading to the misconduct...
February 2016: International Journal of Clinical Oncology
Jay Herson
Research misconduct and fraud in clinical research is an increasing problem facing the scientific community. This problem is expected to increase due to discoveries in central statistical monitoring and with the increase in first-time clinical trial investigators in the increasingly global reach of oncology clinical trials. This paper explores the most common forms of fraud in clinical trials in order to develop offensive and defensive strategies to deal with fraud. The offensive strategies are used when fraud is detected during a trial and the defensive strategies are those design strategies that seek to minimize or eliminate the effect of fraud...
February 2016: International Journal of Clinical Oncology
Katherine Huppler Hullsiek, Jonathan M Kagan, Nicole Engen, Jesper Grarup, Fleur Hudson, Eileen T Denning, Catherine Carey, David Courtney-Rodgers, Elizabeth B Finley, Per O Jansson, Mary T Pearson, Dwight E Peavy, Waldo H Belloso
BACKGROUND: Trial monitoring protects participant safety and study integrity. While monitors commonly go on-site to verify source data, there is little evidence that this practice is efficient or effective. An ongoing international HIV treatment trial (START) provides an opportunity to explore the usefulness of different monitoring approaches. METHODS: All START sites are centrally monitored and required to follow a local monitoring plan requiring specific quality assurance activities...
March 1, 2015: Therapeutic Innovation & Regulatory Science
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