Reutersin uutiset: Amerikan infektiolääkärien yhdistyksen, IDSA:n, hoitosuosituksista vain yksi seitsemästä perustuu riittävään tieteelliseen näyttöön. Useimmat suosituksista on kirjoitettu vain vähäisten tieteellisten näyttöjen pohjalta. Toisinaan tieteellistä näyttöä ei ole lainkaan. Asia tuli julkisuuteen mm IDSA:n Borrelioosia koskevien hoitosuositusten yhteydessä. Niin sanottu "paras hoitokäytäntö" on useimmiten vain pelkkiin mielipiteisiin perustuvaa.
http://www.reuters.com/article/idUSTRE70A06J20110111
Medical "best practice" often no more than opinion
NEW YORK | Mon Jan 10, 2011 7:31pm EST
NEW YORK (Reuters Health) - Even when following medical guidelines to the letter, doctors often use treatments that have little or no scientific support, U.S. researchers said Monday.
They found only one in seven treatment recommendations from the Infectious Diseases Society of America (IDSA) -- a society representing healthcare providers and researchers across the country -- were based on high-quality data from clinical trials.
By contrast, more than half the recommendations relied solely on expert opinion or anecdotal evidence.
"Despite tremendous research efforts, there is still a lot of uncertainty as to what is the best patient care," said Dr. Ole Vielemeyer, an expert in infectious diseases at Drexel University College of Medicine in Philadelphia and one of the study's authors.
"A cookie-cutter approach, where you just have a set of guidelines that you apply no matter what, can be dangerous."
For example, he said, 2003 guidelines advising that patients with pneumonia get antibiotics within hours of seeing the doctor ended up producing an increase in mistaken pneumonia diagnoses and treatment, with no apparent benefits. Indeed, prescribing antibiotics unnecessarily exposes people to the drugs' side effects and could help breed resistant bacteria.
The new analysis, published Monday in the Archives of Internal Medicine, is based on more than 4,200 recommendations made by IDSA between 1994 and 2010.
"These data reinforce that absolute certainty in science or medicine is an illusion," an editorial in the journal notes. "Rather, evaluating evidence is about assessing probability."
Vielemeyer said the findings are likely to apply to other areas of medicine as well, and mentioned an earlier study that found similar results in cardiology.
Doctors across the world look to guidelines when deciding how to treat patients, and insurance companies may use them in coverage decisions.
Because they are drafted by leading experts in the field, they are generally understood to reflect the best medical knowledge available. "People commonly associate guidelines with practicing evidence-based medicine," said Vielemeyer.
But often the relevant clinical studies simply haven't been done. In the absence of evidence, the recommendations end up depending largely on who's on the guideline-drafting panel and any assumptions or opinions they may bring to the process.
In 2008, for instance, then-attorney general of Connecticut Richard Blumenthal sued IDSA for stacking a panel with experts who didn't believe in the controversial "chronic" version of Lyme disease, a tick-borne illness.
While the guidelines were upheld by an independent review panel last April, Blumenthal still expressed concern over "improper voting procedures."
"We are operating on a lot of bias," acknowledged Dr. Larry Baddour, who chairs the division of infectious diseases at Mayo Clinic College of Medicine in Rochester, Minnesota, and has been on several IDSA panels. He recently published findings similar to those of the current study in the IDSA's journal Clinical Infectious Diseases.
Hoitosuositukset perustuvat harvoin tieteelliseen näyttöön
Valvojat: Jatta1001, Borrelioosiyhdistys, Bb
Infektiolääkärien hoitosuosituksia käsittelevän tutkimuksen mukaan: "Yli puolet IDSA:n tämänhetkisistä hoitosuosituksista perustuu ainoastaan jonkun tietyn"asiantuntijan" lausuntoihin. Lääkärien tulee olla varovaisia eikä hoitopäätöksiä tule tehdä yksinomaan hoitosuositusten pohjalta."
Analysis of Overall Level of Evidence Behind Infectious Diseases Society of America Practice Guidelines
Dong Heun Lee, MD; Ole Vielemeyer, MD
Arch Intern Med. 2011;171(1):18-22. doi:10.1001/archinternmed.2010.482
Background Clinical practice guidelines are developed to assist in patient care. Physicians may assume that following such guidelines means practicing evidence-based medicine. However, the quality of supporting literature can vary greatly.
Methods We analyzed the strength of recommendation and overall quality of evidence behind 41 Infectious Diseases Society of America (IDSA) guidelines released between January 1994 and May 2010. Individual recommendations were classified based on their strength of recommendation (levels A through C) and quality of evidence (levels I through III). Guidelines not following this format were excluded from further analysis. Evolution of IDSA guidelines was assessed by comparing 5 recently updated guidelines with their earlier ersions.
Results In the 41 analyzed guidelines, 4218 individual recommendations were found and tabulated. Fourteen percent of the recommendations were classified as level I, 31% as level II, and 55% as level III evidence. Among class A recommendations (good evidence for support), 23% were level I (≥1 randomized controlled trial) and 37% were based on expert opinion only (level III). Updated guidelines expanded the absolute number of individual recommendations substantially. However, few were due to a sizable increase in level I evidence; most additional recommendations had level II and III evidence.
Conclusions More than half of the current recommendations of the IDSA are based on level III evidence only. Until more data from well-designed controlled clinical trials become available, physicians should remain cautious when using current guidelines as the sole source guiding patient care decisions.
Analysis of Overall Level of Evidence Behind Infectious Diseases Society of America Practice Guidelines
Dong Heun Lee, MD; Ole Vielemeyer, MD
Arch Intern Med. 2011;171(1):18-22. doi:10.1001/archinternmed.2010.482
Background Clinical practice guidelines are developed to assist in patient care. Physicians may assume that following such guidelines means practicing evidence-based medicine. However, the quality of supporting literature can vary greatly.
Methods We analyzed the strength of recommendation and overall quality of evidence behind 41 Infectious Diseases Society of America (IDSA) guidelines released between January 1994 and May 2010. Individual recommendations were classified based on their strength of recommendation (levels A through C) and quality of evidence (levels I through III). Guidelines not following this format were excluded from further analysis. Evolution of IDSA guidelines was assessed by comparing 5 recently updated guidelines with their earlier ersions.
Results In the 41 analyzed guidelines, 4218 individual recommendations were found and tabulated. Fourteen percent of the recommendations were classified as level I, 31% as level II, and 55% as level III evidence. Among class A recommendations (good evidence for support), 23% were level I (≥1 randomized controlled trial) and 37% were based on expert opinion only (level III). Updated guidelines expanded the absolute number of individual recommendations substantially. However, few were due to a sizable increase in level I evidence; most additional recommendations had level II and III evidence.
Conclusions More than half of the current recommendations of the IDSA are based on level III evidence only. Until more data from well-designed controlled clinical trials become available, physicians should remain cautious when using current guidelines as the sole source guiding patient care decisions.
Suurin osa infektiotaudeissa käytetyistä käypä hoito-suosituksista ei perustu tieteellisiin tutkimuksiin. Ne eivät kerro yksittäisissä tapauksissa mitä hoitoa potilaalle tulee antaa. Ne toimivat korkeintaan ohjeellisina.
Most Guidelines for Infectious Diseases Don't Come From Clinical Trial Findings
Majority grounded in expert opinion, case studies, research shows
Tuesday, January 11, 2011
TUESDAY, Jan. 11 (HealthDay News) -- Most recommendations on how to treat common infectious diseases are grounded in expert opinions or case reports, and not evidence from clinical trials, new research indicates.
That's not necessarily a bad thing, according to a study appearing in the Jan. 10 issue of the Archives of Internal Medicine, but it may be a wake-up call for more attention to be paid to hard research on infectious disease.
"We were surprised to see that even though they represent a large body of data and a huge amount of work done by many others, that more than half of those individual recommendations are based on the lowest quality of evidence, which is either an expert opinion or a case report or case series," said study co-author Dr. Ole Vielemeyer, an assistant professor of medicine in the division of infectious diseases and HIV medicine at Drexel University College of Medicine in Philadelphia.
The problem, he and others say, is that younger doctors in particular may look at these recommendations as something akin to gospel.
"Sometimes doctors-in-training think if it's written in the guidelines, there must be strong evidence behind it," said Vielemeyer. "They equate the two things without looking at the evidence behind it."
"Guidelines are there to guide people. They're not there to make decisions," added Dr. Paola Lichtenberger, an assistant professor of clinical medicine in the division of infectious diseases at the University of Miami Miller School of Medicine. "They tell you what facts we know, what experts are doing and what's the evidence behind them."
Still, she said, "I do think that infectious diseases need more clinical trials. It's quite a new field."
These researchers took a close look at the underlying basis for 41 different clinical practice guidelines that were set between 1994 and May 2010 for the treatment of a number of leading infectious diseases such as such as bacterial meningitis, infectious diarrhea, Lyme disease and community-acquired pneumonia.
The 41 guidelines contained 4,218 individual recommendations, which the authors assessed on both quality and strength.
Fourteen percent of these were determined to have "level I evidence," meaning they had at least one randomized clinical trial, the gold standard of science, to back them up; 31 percent had "level II" evidence, meaning evidence from one well-conducted study, even though it wasn't a randomized controlled trial.
But more than half of the recommendations (55 percent) had only level III evidence, meaning the recommendations were based on the opinions of individual experts or panels, or case descriptions.
Globetrotters will be happy to know that travel medicine guidelines on infectious disease tended to have the highest quality of evidence behind them.
And the authors also found that updated guidelines did tend to contain more references than their predecessors, indicating that more studies are being done.
Except for HIV/AIDS, it is notoriously difficult to conduct good trials on infectious diseases, the experts said. Either there aren't enough people that contract these illnesses, they're difficult to diagnose or trials would simply be unethical to conduct -- for example, whether hand washing might reduce the risk of hospital-acquired infections.
Although the current IDSA [Infectious Diseases Society of America] guidelines are "as good as the evidence out there in the literature," Vielemeyer said, patients might get better treatment if there was more evidence to back up certain practices.
For example, he said, "there's still overuse of antibiotics. Often it's too long a duration and all these medications have side effects," he said. "If we had good evidence that three days of antibiotics is enough rather than seven days, I think that would make a difference."
Attorneys, too, might take note of how guidelines are formulated, Lichtenberger said.
"Lawyers assume that the guidelines are the last word [but] the guidelines are used to guide . . . they cannot in a single case tell you what to do," she said. "That's why the physician comes into the act and says, 'Okay, for my patient the guidelines are appropriate or the guidelines definitely are not for [this patient].'"
SOURCES: Paola Lichtenberger, M.D., assistant professor, clinical medicine, division of infectious diseases, University of Miami Miller School of Medicine; Ole Vielemeyer, M.D., assistant professor, medicine, division of infectious diseases and HIV medicine, Drexel University College of Medicine, Philadelphia; Jan. 10, 2011, Archives of Internal Medicine
HealthDay
http://www.nlm.nih.gov/medlineplus/news ... 07551.html
Most Guidelines for Infectious Diseases Don't Come From Clinical Trial Findings
Majority grounded in expert opinion, case studies, research shows
Tuesday, January 11, 2011
TUESDAY, Jan. 11 (HealthDay News) -- Most recommendations on how to treat common infectious diseases are grounded in expert opinions or case reports, and not evidence from clinical trials, new research indicates.
That's not necessarily a bad thing, according to a study appearing in the Jan. 10 issue of the Archives of Internal Medicine, but it may be a wake-up call for more attention to be paid to hard research on infectious disease.
"We were surprised to see that even though they represent a large body of data and a huge amount of work done by many others, that more than half of those individual recommendations are based on the lowest quality of evidence, which is either an expert opinion or a case report or case series," said study co-author Dr. Ole Vielemeyer, an assistant professor of medicine in the division of infectious diseases and HIV medicine at Drexel University College of Medicine in Philadelphia.
The problem, he and others say, is that younger doctors in particular may look at these recommendations as something akin to gospel.
"Sometimes doctors-in-training think if it's written in the guidelines, there must be strong evidence behind it," said Vielemeyer. "They equate the two things without looking at the evidence behind it."
"Guidelines are there to guide people. They're not there to make decisions," added Dr. Paola Lichtenberger, an assistant professor of clinical medicine in the division of infectious diseases at the University of Miami Miller School of Medicine. "They tell you what facts we know, what experts are doing and what's the evidence behind them."
Still, she said, "I do think that infectious diseases need more clinical trials. It's quite a new field."
These researchers took a close look at the underlying basis for 41 different clinical practice guidelines that were set between 1994 and May 2010 for the treatment of a number of leading infectious diseases such as such as bacterial meningitis, infectious diarrhea, Lyme disease and community-acquired pneumonia.
The 41 guidelines contained 4,218 individual recommendations, which the authors assessed on both quality and strength.
Fourteen percent of these were determined to have "level I evidence," meaning they had at least one randomized clinical trial, the gold standard of science, to back them up; 31 percent had "level II" evidence, meaning evidence from one well-conducted study, even though it wasn't a randomized controlled trial.
But more than half of the recommendations (55 percent) had only level III evidence, meaning the recommendations were based on the opinions of individual experts or panels, or case descriptions.
Globetrotters will be happy to know that travel medicine guidelines on infectious disease tended to have the highest quality of evidence behind them.
And the authors also found that updated guidelines did tend to contain more references than their predecessors, indicating that more studies are being done.
Except for HIV/AIDS, it is notoriously difficult to conduct good trials on infectious diseases, the experts said. Either there aren't enough people that contract these illnesses, they're difficult to diagnose or trials would simply be unethical to conduct -- for example, whether hand washing might reduce the risk of hospital-acquired infections.
Although the current IDSA [Infectious Diseases Society of America] guidelines are "as good as the evidence out there in the literature," Vielemeyer said, patients might get better treatment if there was more evidence to back up certain practices.
For example, he said, "there's still overuse of antibiotics. Often it's too long a duration and all these medications have side effects," he said. "If we had good evidence that three days of antibiotics is enough rather than seven days, I think that would make a difference."
Attorneys, too, might take note of how guidelines are formulated, Lichtenberger said.
"Lawyers assume that the guidelines are the last word [but] the guidelines are used to guide . . . they cannot in a single case tell you what to do," she said. "That's why the physician comes into the act and says, 'Okay, for my patient the guidelines are appropriate or the guidelines definitely are not for [this patient].'"
SOURCES: Paola Lichtenberger, M.D., assistant professor, clinical medicine, division of infectious diseases, University of Miami Miller School of Medicine; Ole Vielemeyer, M.D., assistant professor, medicine, division of infectious diseases and HIV medicine, Drexel University College of Medicine, Philadelphia; Jan. 10, 2011, Archives of Internal Medicine
HealthDay
http://www.nlm.nih.gov/medlineplus/news ... 07551.html