15 More Medical Procedures To Avoid
The Mayo Clinic's review of ten year's worth of medical reversals published by a leading journal turned up a host of medical procedures that were once thought to be the standard of care. The latest evidence says that they are not worth the risk or the cost.
1) Anticonvulsant drugs during pregnancy
In 2001 a large observational study confirmed suspicions that anticonvulsants taken in pregnancy increase the risk of fetal abnormality.
2) Chelation therapy to prevent cognitive impairment in children with moderately elevated lead levels
Using chelation therapy with succimer did reduce neuropsychological delays in a randomized, placebo-controlled trial of children with moderately high blood lead levels.
3) Treatment of asymptomatic Trichomonas vaginalis during pregnancy
A randomized trial found that using metronidazole did not prevent preterm delivery in women with asymptomatic Trichomonas vaginalis.
4) Estrogen plus progestin hormone therapy to reduce heart disease or coronary artery disease
Postmenopausal women were randomized and given either estrogen/progesterone or a placebo. After 5 years the hormone replacement therapy had provided no protection against cardiac disease. In a second study postmenopausal hormone therapy did not provide protection against coronary-artery artherosclerosis either.
5) Nebulized epinephrine for infants with acute bronchiolitis
Even though epinephrine tratmentfor infants provides short-term improvement in bronchiolitis symptoms, a randomized, double blind study found that it did not shorten the overall time spent in the hospital.
6) Corticosteroids for bronchiolitis in children
Oral dexamethasone, given as a single dose in the emergency room, did not improve outcomes or reduce hospitalizations for children in a randomized and controlled study.
7) Lung transplant for cystic fibrosis
A large retrospective study found that lung transplants cannot be expected to extend life or improve quality of life for end-stage cystic fibrosis patients.
8) Corticosteroids for preschool children with wheezing due to upper respiratory infections
Virus-induced wheezing was not reduced in children who were treated with prednisolone in a large, randomized and double-blind trial.
9) Acyclovir for Bell's Palsy
A randomized, controlled study found that acyclovir, either alone or as an adjunct therapy, did not benefit patients.
10) Saw Palmetto for prostate enlargement
A year-long double-blind trial of 225 middle-aged men found they had no improvement after using saw palmetto (160 mg twice per day) for the treatment of benign prostatic hyperplasia.
11) Antidepressants as an adjunct in bipolar disorder
Adding standard antidepressants to a patient's regimen neither was not found to increase mood polarity but it didn't decrease it either.
12) Irradiation for breast cancer in women over 70
For women over 70 who have a lumpectomy with Tamoxifen for the treatment of estrogen receptor positive breast cancer the addition of irradiation was not better than lumpectomy with Tamoxifen alone in a randomized study.
13) Stents instead of artery bypass for multivessel coronary bypass disease
A large observational study in New York State found that stenting did not work better than traditional coronary-artery bypass for patients with disease in mulitiple vessels.
14) Vertebroplasty for fractured spinal bone
Despite being paid for by Medicare and performed on over 27,000 patients in 2004, vertebroplasty (the injection of cement into the bone) produced no better results than a sham procedure.
15) Delay of epidural anesthesia for women in labor
A 2005 study found that using systemic opioids in early labor gave did not reduce C-section rates compared to epidurals.
Thursday, September 19, 2013
Friday, August 30, 2013
10 Medical Practices that Aren’t Worth the Money
There are plenty of media reports about exciting advances in medicine. But those same outlets seem to go silent when what had initially appeared to be a breakthrough fails the next round of studies. It happens surprisingly often. This becomes a problem when practioners don't keep up with current research. They may continue to use older treatments or procedures, even after those interventions have been shown to be ineffective or even harmful. The Mayo Foundation for Medical Education and Research recently set out to address this problem. Their team, led by Dr. Vinay Prasad, looked at ten years of research articles published in a top journal to examine how many of the treatments, procedures, tests, surgeries, screenings, medications or other interventions in use today have truly been shown to work. Only 38% of articles evaluating established treatments found them to be beneficial. More than 40% of the published studies looking at an established treatment found it to be no better than or worse than the standard practice. To be clear, this doesn’t mean that 40% of procedures were ineffective. It means that in 40% of the studies reviewed, earlier positive results were superseded by later studies that reversed initial findings. To disprove earlier work a new study had to be more rigorously designed, better powered or better controlled.
1) Prolonged antibiotic treatment for persistent symptoms of Lyme disease. A 90-day course of antibiotics didn’t lead to patient improvement in a randomized, placebo-controlled trial.
2) The use of mite-allergen impermeable mattress pads and pillow covers to prevent asthma in adults. A double-blind, placebo-controlled and randomized study done in 2003 found this type of bedding had no impact on asthma symptoms.
3) Aggressive control of blood sugar to prevent heart disease. A large 2008 study found that intensive glucose lowering in diabetics actually increased mortality and did not prevent cardiac problems. Adhering to more permissive glucose targets gave patients better outcomes.
4) Naltrexone to treat alcoholism. A multi-center, randomized and placebo-controlled study failed to find that naltrexone, an opioid-receptor antagonist, added any benefit to standard psychosocial treatment.
5) Antibiotics for asymptomatic UTIs in diabetic women. In 2002 a randomized trial found that antibiotics did not reduce diabetic women’s time to symptomatic infection, or the number of complications due to urinary tract infections.
6) Arthroscopic surgery for osteoarthritis of the knee. Two controlled studies failed to find benefit from this procedure.
7) Hypothermia during aneurysm surgery. The Intraoperative Hypothermia for Aneurysm Surgery Trial (IHAST) found in 2005 that cooling patients during neurosurgery for aneurysm provided no post-operative neurologic benefit.
8) High-dose chemotherapy with autologous stem-cell transplants for high-risk breast cancer. Even though this procedure reduced cancer relapse rates in the affected breast/axillary area , a randomized trial failed to find that it increased survival rates compared to conventional adjuvant chemotherapy.
9) Preimplantation genetic screening for IVF. Genetic screening during in vitro fertilization for women of advanced maternal age was studied in a multicenter, double-blind study. The researchers concluded that preimplantation genetic screening actually reduced the number of pregnancies and live births.
10) Inserting stents in patients with coronary artery infarction. In a randomized trial of people who had suffered total blockage of an artery (myocardial infarction), patients were randomly assigned to a group who received either optimal medical therapy or optimal medical therapy with stents. The stented group did no better in terms of survival rate, reinfarction or heart failure.
Read the Study: A Decade of Reversal: An Analysis of 146 Contradicted Medical Practices
By Vinay Prasad,MD; Andrae Vandross, MD; Caitlin Toomey, MD; Michael Cheung, MD; Fason Rho, MD; Steven Quinn,MD; Jacob Chacko, MD; Durga Bonkar, MD; Victor Gall, MD; Senthil Selvaraj, MD; Nancy Ho, MD; and Adam Cifu, MD
There are plenty of media reports about exciting advances in medicine. But those same outlets seem to go silent when what had initially appeared to be a breakthrough fails the next round of studies. It happens surprisingly often. This becomes a problem when practioners don't keep up with current research. They may continue to use older treatments or procedures, even after those interventions have been shown to be ineffective or even harmful. The Mayo Foundation for Medical Education and Research recently set out to address this problem. Their team, led by Dr. Vinay Prasad, looked at ten years of research articles published in a top journal to examine how many of the treatments, procedures, tests, surgeries, screenings, medications or other interventions in use today have truly been shown to work. Only 38% of articles evaluating established treatments found them to be beneficial. More than 40% of the published studies looking at an established treatment found it to be no better than or worse than the standard practice. To be clear, this doesn’t mean that 40% of procedures were ineffective. It means that in 40% of the studies reviewed, earlier positive results were superseded by later studies that reversed initial findings. To disprove earlier work a new study had to be more rigorously designed, better powered or better controlled.
Here are some of the practices that didn't pass that second look:
2) The use of mite-allergen impermeable mattress pads and pillow covers to prevent asthma in adults. A double-blind, placebo-controlled and randomized study done in 2003 found this type of bedding had no impact on asthma symptoms.
3) Aggressive control of blood sugar to prevent heart disease. A large 2008 study found that intensive glucose lowering in diabetics actually increased mortality and did not prevent cardiac problems. Adhering to more permissive glucose targets gave patients better outcomes.
4) Naltrexone to treat alcoholism. A multi-center, randomized and placebo-controlled study failed to find that naltrexone, an opioid-receptor antagonist, added any benefit to standard psychosocial treatment.
5) Antibiotics for asymptomatic UTIs in diabetic women. In 2002 a randomized trial found that antibiotics did not reduce diabetic women’s time to symptomatic infection, or the number of complications due to urinary tract infections.
6) Arthroscopic surgery for osteoarthritis of the knee. Two controlled studies failed to find benefit from this procedure.
7) Hypothermia during aneurysm surgery. The Intraoperative Hypothermia for Aneurysm Surgery Trial (IHAST) found in 2005 that cooling patients during neurosurgery for aneurysm provided no post-operative neurologic benefit.
8) High-dose chemotherapy with autologous stem-cell transplants for high-risk breast cancer. Even though this procedure reduced cancer relapse rates in the affected breast/axillary area , a randomized trial failed to find that it increased survival rates compared to conventional adjuvant chemotherapy.
9) Preimplantation genetic screening for IVF. Genetic screening during in vitro fertilization for women of advanced maternal age was studied in a multicenter, double-blind study. The researchers concluded that preimplantation genetic screening actually reduced the number of pregnancies and live births.
10) Inserting stents in patients with coronary artery infarction. In a randomized trial of people who had suffered total blockage of an artery (myocardial infarction), patients were randomly assigned to a group who received either optimal medical therapy or optimal medical therapy with stents. The stented group did no better in terms of survival rate, reinfarction or heart failure.
Read the Study: A Decade of Reversal: An Analysis of 146 Contradicted Medical Practices
By Vinay Prasad,MD; Andrae Vandross, MD; Caitlin Toomey, MD; Michael Cheung, MD; Fason Rho, MD; Steven Quinn,MD; Jacob Chacko, MD; Durga Bonkar, MD; Victor Gall, MD; Senthil Selvaraj, MD; Nancy Ho, MD; and Adam Cifu, MD
Friday, August 9, 2013
How High Performance Organizations Get the Most Out of Training
Best Practices from the Science of Training
Training works, if it is well designed. Researchers have been studying training
methods for 40 years now, and they've got robust evidence to show that done
right, training boosts organizational effectiveness. NASA and the US Navy
recently sponsored a study to find out what cognitive science, engineering, and
industrial psychology have taught us in the last few decades. The project’s
lead author, Eduardo Salas at the University of Central Florida, found that
it’s crucial for training systems to be properly integrated into the organization. His report identifies the keys to spending
training dollars wisely.
1. It may seem
obvious, but the first thing to consider is whether you really need training at
all. Decide if the issue is actually structural or organizational. If it is,
don’t waste time and money throwing training at problems it won’t fix.
2. Do a needs
assessment. What are organizational
needs, and then what skills, knowledge or competencies are required to fulfill
those needs? Make sure that the training
program is tailored to these needs.
There are lots of fads and glitzy technological delivery systems out
there but only use training programs that have measurable effects on job
performance.
3. Do a personnel assessment. Identify which employees have the greatest
gap between competencies and
requirements and focus on those employees. Don’t train everybody unless there is a specific reason to.
4. Make sure the training is suited to the needs of those
whose skills need upgrading. Older
workers, for example, may require a slower pace to master new technologies.
5. Teach supervisors
how to focus on training’s benefits and make sure it is regarded positively
within the organization. Introduce training as
an opportunity to advance the employee’s career, not as a test or an indictment
of his or her incompetence. On the other hand, don’t oversell it. Unrealistic expectations lower performance.
6. Maximize learning
by not overloading trainees with too much content. Focus on what is crucial to know and how to
access the rest.
7. Teach error
tolerance. Build in difficulties and
challenges so that trainees have the opportunity to fail. Good training teaches emotional as well as
cognitive skills. Employees need to
become comfortable with detecting and correcting their own errors.
8. Model proficiency and competence with the new material or
skill, and make sure the training includes practice and feed-back.
9. Create ongoing
learning by debriefing afterwards and linking trainees into communities of
practice.
10. Minimize skill
decay by scheduling training as close to its application as possible.
Wednesday, July 24, 2013
Simple Tools to Help People Navigate the ACA
As the government rolls out the Affordable Care Act a lot of people are going to want to know how they will be affected and what, if anything, they should sign up for. They will need to make decisions regarding the level of care they can afford and the benefits that they need. The non-profit Kaiser Family Foundation has decided to make the process as painless as possible by creating a simple introductory video. It provides an overview of the Act's provisions and explains the different ways people will be getting coverage. To create an estimate of their costs the video also links to a subsidy calculator.
The calculator estimates what individuals who purchase their own insurance through the new exchanges will get. It asks users to input age, income and number of dependents. For example, a 21-year old making $20,000 a year can enroll in the silver plan for about $85 a month or the bronze plan for about $42 a month.
In order to keep costs down it is particularly important that young people aged 18-35 sign up. Sarah Kliff over at the Washington Post's Wonk Blog has been keeping us up to date on the White House's efforts to roll out the program smoothly. If you want more information about where they are concentrating their efforts and the target demographics they are trying to reach see her recent post.
The calculator estimates what individuals who purchase their own insurance through the new exchanges will get. It asks users to input age, income and number of dependents. For example, a 21-year old making $20,000 a year can enroll in the silver plan for about $85 a month or the bronze plan for about $42 a month.
In order to keep costs down it is particularly important that young people aged 18-35 sign up. Sarah Kliff over at the Washington Post's Wonk Blog has been keeping us up to date on the White House's efforts to roll out the program smoothly. If you want more information about where they are concentrating their efforts and the target demographics they are trying to reach see her recent post.
Wednesday, July 17, 2013
Thyroid Cancer "Epidemic" Likely Due to Overdiagnosis
Detection Rates Continue to Rise But Thyroid Cancer Deaths Stay the Same
The Takeaway
1. The number of papillary thyroid cancer cases treated has been going up in the US, Canada and Western Europe. In 2009 the incidence was three times what it had been in 1973, rising from 3.5 cases per 100,000 people to 12.5 cases per 100,000.
2. In a study published July 8th in the journal Thyroid, a team led by Luc Morris, MD MSc at Memorial Sloan-Kettering Cancer Center found a positive correlation between indicators of healthcare use and thyroid cancer diagnosis in the US. This looks like good news but it's actually a problem. The poor and those without access to care are getting fewer thyroid cancer diagnoses than those with access, even though both succumb to the disease at the same rate.
2. In a study published July 8th in the journal Thyroid, a team led by Luc Morris, MD MSc at Memorial Sloan-Kettering Cancer Center found a positive correlation between indicators of healthcare use and thyroid cancer diagnosis in the US. This looks like good news but it's actually a problem. The poor and those without access to care are getting fewer thyroid cancer diagnoses than those with access, even though both succumb to the disease at the same rate.
3. If more cases of a fatal disease are diagnosed and treated, but death rates don't decrease, the new cases being detected are likely part of a subclinical disease reservoir. These are cases that would not have gone on to cause harm if left alone. Treating subclinical cases is not only unnecessary, it is also harmful and costly. This is what is meant by the term overdiagnosis.
4. The authors speculate that the increase is due to the use of sensitive diagnostic tools such as ultrasonography, fine needle aspiration biopsy and the fact that small nodules sometimes show up "incidentally" when radiographic imaging is done for other reasons.
5. Census 2000 data was used to look at 9 socioeconomic variables across 443 US counties. SEER data provided patient demographic information, tumor and survival characteristics. An ecologic analysis and regression analysis were performed. Counties with higher income and education levels had more thyroid cancer cases than counties with more unemployment, non-English speakers, and poverty.
The One Minute Summary
Overdiagnosis is thought to occur when a reservoir of previously undetected, and non-lethal disease is revealed by new, more sensitive technologies. Papillary thyroid cancer fits this description because autopsies have revealed that between 8 and 35% percent of us are likely to go to our graves with detectable thyroid tumors, even if we have died from other causes. This latest study adds new evidence to the case for concluding that the rise in thyroid cancers over the last three decades is due to changes in the techniques of detection, rather than some change in the environment. It found that where there are more poor, non-English speaking, or unemployed adults, there is a lower rate of thyroid cancer diagnosis. And, crucially, that lower rate of diagnosis doesn't change life expectancy.
Read the Study: The Increasing Incidence of Thyroid Cancer: The Influence of Access to Care
By Luc Morris, MD MSc; Andrew Sikora, MD PhD; Tor Tosteson, ScD; and Louis Davis, MD MS
5. Census 2000 data was used to look at 9 socioeconomic variables across 443 US counties. SEER data provided patient demographic information, tumor and survival characteristics. An ecologic analysis and regression analysis were performed. Counties with higher income and education levels had more thyroid cancer cases than counties with more unemployment, non-English speakers, and poverty.
The One Minute Summary
Overdiagnosis is thought to occur when a reservoir of previously undetected, and non-lethal disease is revealed by new, more sensitive technologies. Papillary thyroid cancer fits this description because autopsies have revealed that between 8 and 35% percent of us are likely to go to our graves with detectable thyroid tumors, even if we have died from other causes. This latest study adds new evidence to the case for concluding that the rise in thyroid cancers over the last three decades is due to changes in the techniques of detection, rather than some change in the environment. It found that where there are more poor, non-English speaking, or unemployed adults, there is a lower rate of thyroid cancer diagnosis. And, crucially, that lower rate of diagnosis doesn't change life expectancy.
Read the Study: The Increasing Incidence of Thyroid Cancer: The Influence of Access to Care
By Luc Morris, MD MSc; Andrew Sikora, MD PhD; Tor Tosteson, ScD; and Louis Davis, MD MS
Wednesday, June 19, 2013
Study Finds That New Drugs Don't Look So Good Now that All Clinical Trials Must Be Registered
The FDA has traditionally required drug manufacturers to show that their products are more effective than a placebo, and that they don't do harm. But that is a low bar to jump. What patients and medical professionals really need to know is whether a new drug is better than the ones currently in use. Comparative effectiveness research is designed to answer this, and more specific questions. Does a new drug have fewer side effects, work in different care settings, work better for certain groups of patients, or in some other way prove its mettle?
This month Mark Olfson and Steven C. Marcus published a study in Health Affairs using the statistical tools of effectiveness research to take a new look at old drug studies, those reported in major medical journals from 1966 to 2010. A random sample of studies found that over time the effect size of new drugs has decreased. The newer the drug, the less effective it tends to be. We are getting diminishing returns for our health care buck.
The authors discussed several reasons this could be happening. New drugs are still coming to market, but there have been relatively few new drug classes. This is especially true of antibiotics. A second issue is that with the requirement in the U.S. since 2007 that all clinical trials be registered, there is no longer the opportunity to select only the strongest studies for publication. This would imply that the effectiveness of our medications was being statistically pumped up before the ClinicalTrials.gov registry was formed. A third possibility is that drug manufacturers have preferred to bring variations of already popular drugs to market rather than investing the time and money to develop new ones. In order to get the new version to pass FDA review they may resort to increasing the number of participants in the trial. Even a very small effect size can look statistically significant against a placebo with a large enough sample size. Sample sizes have indeed increased over the study period, making it a real possibility that drugs offering only a small tweak from standard treatments can pass review.
As the authors note, $100 billion is spent in the U.S. on biomedical research every year, and most of that is going into clinical trials. The diminishing rate of returns that this money has had in terms of clinical effectiveness makes it imperative that we shine light on this process. We need to guard against having clinical trials being used as marketing tools, and put the focus back on the reduction of human harm and suffering.
Read the Study: Decline in Placebo-Controlled Trial Results Suggests New Directions For Comparative Effectiveness Research
By Mark Olfson and Steven C. Marcus
As the authors note, $100 billion is spent in the U.S. on biomedical research every year, and most of that is going into clinical trials. The diminishing rate of returns that this money has had in terms of clinical effectiveness makes it imperative that we shine light on this process. We need to guard against having clinical trials being used as marketing tools, and put the focus back on the reduction of human harm and suffering.
Read the Study: Decline in Placebo-Controlled Trial Results Suggests New Directions For Comparative Effectiveness Research
By Mark Olfson and Steven C. Marcus
Monday, June 3, 2013
The Affordable Care Act's Surprisingly Low Premiums
As implementation of the Affordable Care Act ramps, up two unexpected developments have been in the news. Some health plans look to be offered at a cost well below that predicted. This is good news and bad news.
The good news is that California's Insurance Exchange, called Covered California, has released its prices. It will be offering plans for 2014 at an unexpectedly low cost. This is because the Exchanges, which were designed to create a competitive marketplace for health insurance are actually functioning like a competitive marketplace. Consumers can choose between four levels of plan: bronze, silver, gold or platinum. The more the plan costs up front, the lower the out-of pocket expenses will be. All the insurance companies offering bronze plans have to include the same types of services for those plans. All the silver plans have to be comparable to each other, and so on. Now that plans can actually be rated in a simple and transparent way, there is an incentive for insurers to bid low and compete against each other to gain market share.
Covered California is offering low rates despite expectations that premiums under Obamacare were going to rise. A widely reported study by the Milliman Company predicted that while older Americans aged 40-59 should see lowered costs, younger males would see their cost go up. A 28-year-old man making $50,000 a year, for example, had been expected to pay as much as $450 a month for a silver plan. The actual cost in California is going to be around $250 a month. This is comparable in cost to high-deductible plans on the private insurance market right now which offer much-less comprehensive benefits. All plans purchased through Insurance Exchanges must cover at least 60% of the patient's costs, including co-pays and deductibles. California residents who buy through Covered California are going to get a good deal.
The same can't be said for all low-wage workers at large companies. Christopher Weaver and Anna Wilde Matthews at the Wall Street Journal recently reported that some companies with large numbers of service workers have been worried about the cost of the ACA's requirement to offer those employees health benefits. They are said to be in talks with insurance companies to craft new plans that will be very cheap, in the order of $40 a month, but will offer extremely limited coverage. Hospital stays, surgery and prenatal care will be excluded.
These firms are hoping to find a loop-hole in the law that allows them to offer low-benefit plans (termed mini-meds or "skinny plans" in insurance industry lingo). Since most large firms offering insurance to their employees actually offer good plans in order to retain workers (think Google), big companies have been allowed to choose their own plans. The Department of Health and Human Services didn't anticipate that offering skinny plans might be the way that some companies would try to lower premium costs. It is unlikely that they will be allowed to, but watch this space for further developments.
The good news is that California's Insurance Exchange, called Covered California, has released its prices. It will be offering plans for 2014 at an unexpectedly low cost. This is because the Exchanges, which were designed to create a competitive marketplace for health insurance are actually functioning like a competitive marketplace. Consumers can choose between four levels of plan: bronze, silver, gold or platinum. The more the plan costs up front, the lower the out-of pocket expenses will be. All the insurance companies offering bronze plans have to include the same types of services for those plans. All the silver plans have to be comparable to each other, and so on. Now that plans can actually be rated in a simple and transparent way, there is an incentive for insurers to bid low and compete against each other to gain market share.
Covered California is offering low rates despite expectations that premiums under Obamacare were going to rise. A widely reported study by the Milliman Company predicted that while older Americans aged 40-59 should see lowered costs, younger males would see their cost go up. A 28-year-old man making $50,000 a year, for example, had been expected to pay as much as $450 a month for a silver plan. The actual cost in California is going to be around $250 a month. This is comparable in cost to high-deductible plans on the private insurance market right now which offer much-less comprehensive benefits. All plans purchased through Insurance Exchanges must cover at least 60% of the patient's costs, including co-pays and deductibles. California residents who buy through Covered California are going to get a good deal.
The same can't be said for all low-wage workers at large companies. Christopher Weaver and Anna Wilde Matthews at the Wall Street Journal recently reported that some companies with large numbers of service workers have been worried about the cost of the ACA's requirement to offer those employees health benefits. They are said to be in talks with insurance companies to craft new plans that will be very cheap, in the order of $40 a month, but will offer extremely limited coverage. Hospital stays, surgery and prenatal care will be excluded.
These firms are hoping to find a loop-hole in the law that allows them to offer low-benefit plans (termed mini-meds or "skinny plans" in insurance industry lingo). Since most large firms offering insurance to their employees actually offer good plans in order to retain workers (think Google), big companies have been allowed to choose their own plans. The Department of Health and Human Services didn't anticipate that offering skinny plans might be the way that some companies would try to lower premium costs. It is unlikely that they will be allowed to, but watch this space for further developments.
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