All posts; Tags Include "Clinical Research"
- April 18, 2014
- 07:02 AM
- 947 views
Hey, trial lawyers! The FDA is watching you!
by Doug Keene in The Jury Room
And they want you to stop abusing their Adverse Event Reporting System (FAERS). We’ve worked a number of cases recently where FDA warnings were used as evidence at trial and were very interested to see this article in the American Journal of Gastroenterology. And the answer to the skeptic’s question is “no”. No, we don’t […]
Related posts:
Should you ask your overweight female client to diet before trial?
Black? On trial in Florida? You don’t want an all-white jury!
Predic........ Read more »
Tenner S. (2014) Editorial: Isotretinoin and inflammatory bowel disease: trial lawyer misuse of science and FDA warnings. The American Journal of Gastroenterology, 109(4), 570-1. PMID: 24698863
Racine A, Cuerq A, Bijon A, Ricordeau P, Weill A, Allemand H, Chosidow O, Boutron-Ruault MC, & Carbonnel F. (2014) Isotretinoin and risk of inflammatory bowel disease: a French nationwide study. The American Journal of Gastroenterology, 109(4), 563-9. PMID: 24535094
- April 15, 2014
- 08:00 PM
- 1,264 views
New Study Shows Surgical Checklists In Operating Rooms Are Less Effective Than Assumed
by Jalees Rehman in The Next Regeneration
Optimizing such tailored checklists, understanding why some studies indicate benefits of checklists whereas others do not and re-evaluating the efficacy of checklists in the non-academic setting will all require a substantial amount of future research before one can draw definitive conclusions about the efficacy of checklists. Regulatory agencies in Canada and the United Kingdom should reconsider their current mandates. Perhaps an even more important lesson to be learned is that health regulator........ Read more »
Urbach DR, Govindarajan A, Saskin R, Wilton AS, & Baxter NN. (2014) Introduction of surgical safety checklists in Ontario, Canada. The New England Journal of Medicine, 370(11), 1029-38. PMID: 24620866
- April 15, 2014
- 11:43 AM
- 650 views
Religious Belief and Depression Resilience
by William Yates, M.D. in Brain Posts
Identifying risk factors for brain disorders is a key element in clinical research.Understanding protective or resilience factors for brain disorders is also important and receiving increased attention in clinical research.Factors that promote resilience to brain disorders may come from a variety of domains. Religious belief is one domain receiving attention as a potential resilience factor.Miller and colleagues recently published a longitudinal study of religious belief and risk for major ........ Read more »
Miller L, Wickramaratne P, Gameroff MJ, Sage M, Tenke CE, & Weissman MM. (2012) Religiosity and major depression in adults at high risk: a ten-year prospective study. The American journal of psychiatry, 169(1), 89-94. PMID: 21865527
- April 7, 2014
- 11:37 AM
- 650 views
The Genetics of Religious Belief
by William Yates, M.D. in Brain Posts
In the next few posts, I will review some of the recent brain-related research related to religious belief.Religious belief and religious affiliation run in families. This effect is not surprising as parents influence their children's type of religious experience during development.However, there is increasing evidence that adult religious belief and behavior is also influenced by genetic factors independent of family environment experience.Twin studies represent a powerful research model to tea........ Read more »
Button TM, Stallings MC, Rhee SH, Corley RP, & Hewitt JK. (2011) The etiology of stability and change in religious values and religious attendance. Behavior genetics, 41(2), 201-10. PMID: 20711848
Hvidtjørn, D., Petersen, I., Hjelmborg, J., Skytthe, A., Christensen, K., & Hvidt, N. (2013) Familial Resemblance in Religiousness in a Secular Society: A Twin Study. Twin Research and Human Genetics, 16(02), 544-553. DOI: 10.1017/thg.2013.3
Kandler C, & Riemann R. (2013) Genetic and environmental sources of individual religiousness: the roles of individual personality traits and perceived environmental religiousness. Behavior genetics, 43(4), 297-313. PMID: 23681197
- April 3, 2014
- 06:30 PM
- 832 views
In Defense of No Improvement by Medic Madness – Part IV
by Rogue Medic in Rogue Medic
Continuing from Part I, Part II, and Part III in response to what I wrote about the failure of the LUCAS,[1] Sean continues with -
"Another issue I have with this data, is that it doesn’t address the following variables:
Down time
Whether or not bystander CPR was performed
Medications used
Whether or not an advanced airway was placed
Length of resuscitation"... Read more »
Rubertsson S, Lindgren E, Smekal D, Östlund O, Silfverstolpe J, Lichtveld RA, Boomars R, Ahlstedt B, Skoog G, Kastberg R.... (2014) Mechanical chest compressions and simultaneous defibrillation vs conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest: the LINC randomized trial. JAMA : the journal of the American Medical Association, 311(1), 53-61. PMID: 24240611
Rubertsson S, Silfverstolpe J, Rehn L, Nyman T, Lichtveld R, Boomars R, Bruins W, Ahlstedt B, Puggioli H, Lindgren E.... (2013) The study protocol for the LINC (LUCAS in cardiac arrest) study: a study comparing conventional adult out-of-hospital cardiopulmonary resuscitation with a concept with mechanical chest compressions and simultaneous defibrillation. Scandinavian journal of trauma, resuscitation and emergency medicine, 5. PMID: 23351178
- March 27, 2014
- 12:51 PM
- 596 views
Is Insomnia Relief Just a Mouse Click Away?
by William Yates, M.D. in Brain Posts
Cognitive behavioral treatment of insomnia (CBT-I) is increasingly recognized as an important treatment option.However, in some regions of the U.S. and the world, access to this type of therapy is limited and may be cost prohibitive.A recent review of the diagnosis and treatment of insomnia noted the promise of internet-based CBT-I. The promise of internet-based CBT-I is based on several randomized controlled trials.Ritterband and colleagues published a study 44 subjects randomize........ Read more »
Buysse DJ. (2013) Insomnia. JAMA : the journal of the American Medical Association, 309(7), 706-16. PMID: 23423416
Ritterband LM, Thorndike FP, Gonder-Frederick LA, Magee JC, Bailey ET, Saylor DK, & Morin CM. (2009) Efficacy of an Internet-based behavioral intervention for adults with insomnia. Archives of general psychiatry, 66(7), 692-8. PMID: 19581560
Espie CA, Kyle SD, Williams C, Ong JC, Douglas NJ, Hames P, & Brown JS. (2012) A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep, 35(6), 769-81. PMID: 22654196
- March 27, 2014
- 10:15 AM
- 1,198 views
In Defense of No Improvement by Medic Madness - Part III
by Rogue Medic in Rogue Medic
Sean continues to explain how the machine that does not improve outcomes allows him to provide other 'treatments' that do not improve outcomes.
I continue to point out the problems with his excuses.
.... Read more »
Rubertsson S, Lindgren E, Smekal D, Östlund O, Silfverstolpe J, Lichtveld RA, Boomars R, Ahlstedt B, Skoog G, Kastberg R.... (2014) Mechanical chest compressions and simultaneous defibrillation vs conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest: the LINC randomized trial. JAMA : the journal of the American Medical Association, 311(1), 53-61. PMID: 24240611
Larabee TM, Liu KY, Campbell JA, & Little CM. (2012) Vasopressors in cardiac arrest: a systematic review. Resuscitation, 83(8), 932-9. PMID: 22425731
Hagihara A, Hasegawa M, Abe T, Nagata T, Wakata Y, & Miyazaki S. (2012) Prehospital epinephrine use and survival among patients with out-of-hospital cardiac arrest. JAMA : the journal of the American Medical Association, 307(11), 1161-8. PMID: 22436956
Hayashi Y, Iwami T, Kitamura T, Nishiuchi T, Kajino K, Sakai T, Nishiyama C, Nitta M, Hiraide A, & Kai T. (2012) Impact of early intravenous epinephrine administration on outcomes following out-of-hospital cardiac arrest. Circulation journal : official journal of the Japanese Circulation Society, 76(7), 1639-45. PMID: 22481099
Thel MC, Armstrong AL, McNulty SE, Califf RM, & O'Connor CM. (1997) Randomised trial of magnesium in in-hospital cardiac arrest. Duke Internal Medicine Housestaff. Lancet, 350(9087), 1272-6. PMID: 9357406
Allegra J, Lavery R, Cody R, Birnbaum G, Brennan J, Hartman A, Horowitz M, Nashed A, & Yablonski M. (2001) Magnesium sulfate in the treatment of refractory ventricular fibrillation in the prehospital setting. Resuscitation, 49(3), 245-9. PMID: 11719117
Kudenchuk PJ, Cobb LA, Copass MK, Cummins RO, Doherty AM, Fahrenbruch CE, Hallstrom AP, Murray WA, Olsufka M, & Walsh T. (1999) Amiodarone for resuscitation after out-of-hospital cardiac arrest due to ventricular fibrillation. The New England journal of medicine, 341(12), 871-8. PMID: 10486418
- March 25, 2014
- 11:08 AM
- 584 views
When Sleeping Pills Don't Work
by William Yates, M.D. in Brain Posts
Hypnotics or sleeping pills typically are effective and indicated as an option for the short-term relief of transient insomnia.However, a minority of individuals report persistent insomnia and lack of sleep despite use of a hypnotic.When drugs that typically treat a disorder fail to work, it is important to reconsider the accuracy of the diagnosis.Yun Li and colleagues from China recently published a case report illustrating this issue in the Journal of Clinical Sleep Medicine.They reported on a........ Read more »
Li Y, Li Z, Lei F, Du L, & Tang X. (2013) Persistent insomnia despite long-term nightly use of sleeping pills. Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 9(8), 834-6. PMID: 23946716
- March 19, 2014
- 12:01 PM
- 673 views
Naptime Stories Boost Word Learning in Children
by William Yates, M.D. in Brain Posts
Sleep is known to have a beneficial effect on the consolidation of memory.There have been few studies to demonstrate how this effect my be utilized.Williams and Horst recently tested the effect of storybook reading, sleep and word learning in group of 3 year old children.Their study recently published in the journal Frontiers in Psychology randomized 48 three year old children into four groups:Group one: children were read the same story before a napsGroup two: children were read different stori........ Read more »
Williams SE, & Horst JS. (2014) Goodnight book: sleep consolidation improves word learning via storybooks. Frontiers in psychology, 184. PMID: 24624111
- March 18, 2014
- 11:46 AM
- 648 views
Short Sleep Duration in Children with Autism
by William Yates, M.D. in Brain Posts
Parents of children with autism and autism spectrum disorder commonly report sleep problems in their child.However, there have been few prospective systematic studies of sleep in this disorder.Joanna Humphreys from Canada and colleagues from England recently published an important manuscript addressing this topic.They used data from the Avon Longitudinal Study of Parents and Children. This data set includes prospective data collected from a cohort of over 14,000 children born between April 1991 ........ Read more »
Humphreys JS, Gringras P, Blair PS, Scott N, Henderson J, Fleming PJ, & Emond AM. (2014) Sleep patterns in children with autistic spectrum disorders: a prospective cohort study. Archives of disease in childhood, 99(2), 114-8. PMID: 24061777
- March 17, 2014
- 11:10 AM
- 566 views
Brain Gray Matter Volumes in Primary Insomnia
by William Yates, M.D. in Brain Posts
Chronic primary insomnia is a sleep disorder characterized by delayed sleep onset, reduced total sleep duration and fatigue on morning awakening.In addition, by definition chronic primary insomnia cannot be due to a primary medical or psychiatric disorder. Some patients with chronic primary insomnia also demonstrate subjective and objective impairment in concentration and memory.Eun Yeon Joo and colleagues from South Korea recently published an analysis of brain structural features in 27 su........ Read more »
Joo EY, Noh HJ, Kim JS, Koo DL, Kim D, Hwang KJ, Kim JY, Kim ST, Kim MR, & Hong SB. (2013) Brain Gray Matter Deficits in Patients with Chronic Primary Insomnia. Sleep, 36(7), 999-1007. PMID: 23814336
- March 13, 2014
- 12:11 PM
- 652 views
Outcome in REM Sleep Behavior Disorder
by William Yates, M.D. in Brain Posts
This is the second in series of posts examining recent research in sleep and the brain.Rapid eye movement (REM) sleep behavior disorder is a complex sleep problem seen primarily in older adults.REM, or dream sleep, typically occurs with atonia. Atonia is the temporary state of muscle paralysis. This prohibits muscular activity or acting out during dream states.With REM sleep behavior disorder, atonia is not present with REM sleep resulting in motor restlessness, agitation and occasio........ Read more »
Iranzo A, Fernández-Arcos A, Tolosa E, Serradell M, Molinuevo JL, Valldeoriola F, Gelpi E, Vilaseca I, Sánchez-Valle R, Lladó A.... (2014) Neurodegenerative Disorder Risk in Idiopathic REM Sleep Behavior Disorder: Study in 174 Patients. PloS one, 9(2). PMID: 24587002
- March 11, 2014
- 11:55 PM
- 927 views
Who Needs a 12 Lead ECG?
by Rogue Medic in Rogue Medic
Do we do too many 12 lead ECGs on patients who do not have chest pain?
This is something that some people worry about.
Save the electrodes!
Those poor little electrodes are being abused!
Are electrodes being abused?... Read more »
Glickman SW, Shofer FS, Wu MC, Scholer MJ, Ndubuizu A, Peterson ED, Granger CB, Cairns CB, & Glickman LT. (2012) Development and validation of a prioritization rule for obtaining an immediate 12-lead electrocardiogram in the emergency department to identify ST-elevation myocardial infarction. American heart journal, 163(3), 372-82. PMID: 22424007
- March 11, 2014
- 11:33 AM
- 786 views
Variant Prioritization in Rare Mendelian Disorders
by Daniel Koboldt in Massgenomics
Few areas of biomedical research have benefited more from next-gen sequencing than studies of rare inherited diseases. Rapid, inexpensive exome sequencing in individuals with rare, presumably-monogenic diseases has been hugely successful over the past few years. There’s been a lot of discussion in the NGS community about the analysis burden of the large-scale whole-genome sequencing […]... Read more »
Koboldt DC, Larson DE, Sullivan LS, Bowne SJ, Steinberg KM, Churchill JD, Buhr AC, Nutter N, Pierce EA, Blanton SH.... (2014) Exome-Based Mapping and Variant Prioritization for Inherited Mendelian Disorders. American journal of human genetics. PMID: 24560519
- March 11, 2014
- 11:09 AM
- 668 views
Depression-related Sleep Abnormalities Vary By Age
by William Yates, M.D. in Brain Posts
This month I will be focusing on sleep and the brain. The importance of sleep to normal and abnormal brain functioning is receiving increased research attention.A variety of sleep abnormalities have been described in major depression and bipolar affective disorder. Depression has been linked to delayed sleep onset, reduced time to first rapid eye movement (REM) period, reduced sleep efficiency and disruption of the circadian rhythm of sleep.Sleep physiology also varies throughout the lifesp........ Read more »
Robillard, R., Naismith, S., Smith, K., Rogers, N., White, D., Terpening, Z., Ip, T., Hermens, D., Whitwell, B., Scott, E.... (2014) Sleep-Wake Cycle in Young and Older Persons with a Lifetime History of Mood Disorders. PLoS ONE, 9(2). DOI: 10.1371/journal.pone.0087763
- March 5, 2014
- 03:00 PM
- 984 views
The Failure of LUCAS to Improve Outcomes in the LINC Trial
by Rogue Medic in Rogue Medic
We love gadgets in EMS.
Dr. Bryan Bledsoe tells us that if we paint it orange and put a star of life on it, we can sell any product for a lot more money.
How much would you pay to not improve outcomes?
$10,000.00?
$20,000.00?
$30,000.00?
$40,000.00?
$50,000.00?... Read more »
Rubertsson S, Lindgren E, Smekal D, Östlund O, Silfverstolpe J, Lichtveld RA, Boomars R, Ahlstedt B, Skoog G, Kastberg R.... (2014) Mechanical chest compressions and simultaneous defibrillation vs conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest: the LINC randomized trial. JAMA : the journal of the American Medical Association, 311(1), 53-61. PMID: 24240611
- March 3, 2014
- 09:14 AM
- 587 views
Behavioral Weight-Loss in Serious Mental Illness
by William Yates, M.D. in Brain Posts
Individuals with schizophrenia or bipolar disorder are at higher risk for obesity.This risk may be related to physical inactivity, diet or the weight gain commonly associated with psychotropic drug use.Few clinical trials for weight loss have targeted individuals with serious mental illness (SMI). This population may pose specific challenges in recruitment, adherence and outcome.Gail Daumit and colleagues recently published a randomized clinical trial of behavioral weight loss in a cohort with S........ Read more »
Daumit GL, Dickerson FB, Wang NY, Dalcin A, Jerome GJ, Anderson CA, Young DR, Frick KD, Yu A, Gennusa JV 3rd.... (2013) A behavioral weight-loss intervention in persons with serious mental illness. The New England journal of medicine, 368(17), 1594-602. PMID: 23517118
- February 25, 2014
- 11:47 PM
- 790 views
Drug and Alcohol Consumption and Trade and HIV in the Caribbean: A Review of the Literature
by JAID in JScholar Publishers
This consultancy was granted by the Caribbean Health Research Council (CHRC) to assess the state of the literature on possible links between HIV spread and prevalence of drug and alcohol abuse and trade in the region. The methodology was that of a thematic search of existing literature in databases and books or journal publications. Online materials and UN agency reports of relevance were also consulted. Regular meetings were held with CHRC staff to review progress and edit drafts while staff of........ Read more »
Biko Agozino. (2013) Drug and Alcohol Consumption and Trade and HIV in the Caribbean: A Review of the Literature. Journal of HIV/AIDS , 1(2), 1-12. info:/Vol 1: 203
Agozino Biko . (2014) Drug and Alcohol Consumption and Trade and HIV in the Caribbean: A Review of the Literature. JOURNAL OF HIV/AIDS AND INFECTIOUS DISEASES, 2(1), 1-7. DOI: 202
- February 24, 2014
- 08:17 AM
- 736 views
Fish Consumption and Brain Health
by William Yates, M.D. in Brain Posts
I have previously examined outcomes for MRI changes known as brain white matter hyperintensities (WMHI).WMHIs are noted in a minority of adults and are not completely understood. The changes are considered subclinical in nature, meaning they do not reach a threshold for medical significance.However, these subclinical WMHI are linked to higher rates of premature cognitive decline. Absence of WMHI is seen by some as one marker of brain health.Jyrki Virtanen and colleagues from Finl........ Read more »
Virtanen JK, Siscovick DS, Lemaitre RN, Longstreth WT, Spiegelman D, Rimm EB, King IB, & Mozaffarian D. (2013) Circulating omega-3 polyunsaturated fatty acids and subclinical brain abnormalities on MRI in older adults: the Cardiovascular Health Study. Journal of the American Heart Association, 2(5). PMID: 24113325
- February 22, 2014
- 12:09 AM
- 1,260 views
Prevalence and Determinants of Adherence to Highly Active Antiretroviral Therapy (HAART) amongst a Cohort of HIV Positive Women Accessing Treatment in a Tertiary Health Facility in Southern Nigeria
by JAID in JScholar Publishers
Optimal adherence to HAART amongst women living with HIV/AIDS (WLHIV) accounts for more than half of all new infections worldwide. This is particularly crucial for the success of HIV/AIDS treatment programs. In Nigeria, adherence amongst women has remained largely unexplored. This study aims to determine the prevalence and determinants of adherence to HAART amongst HIV positive non-pregnant women receiving treatment in a tertiary health facility in Cross River State, Nigeria... Read more »
Oku AO*, Owoaje ET, Oku OO, Monjok E. (2013) Prevalence and Determinants of Adherence to Highly Active Antiretroviral Therapy (HAART) amongst a Cohort of HIV Positive Women Accessing Treatment in a Tertiary Health Facility in Southern Nigeria. Journal of HIV/AIDS , 1(2), 1-7. info:/Vol 1: 202
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