guidance for guidelines

[Guest guest]

Guidance for Guidelines

Steinbrook, M.D.

Clinical practice guidelines are systematically developed statements that

aim to help physicians and patients reach the best health care decisions. Good

guidelines have many attributes, including validity, reliability,

reproducibility, clinical applicability and flexibility, clarity, development

through a

multidisciplinary process, scheduled reviews, and documentation.1 More than

2000 guidelines are currently represented in the National Guideline

Clearinghouse (_www.guideline.gov_ (http://www.guideline.gov/) ). Medical

specialty

societies are their most common sponsors.

Guidelines rely on both evidence and opinion; they are neither infallible

nor a substitute for clinical judgment. They do, however, go beyond systematic

reviews to recommend what should and should not be done in specific clinical

circumstances. Some are widely respected; they have helped to standardize

care, diminish local variation, and improve health outcomes. However, the

quality of guidelines varies considerably. Among the efforts in the United

States

that are generally considered successful are those of the U.S. Preventive

Services Task Force, the Advisory Committee on Immunization Practices, and the

National Academies, as well as the treatment guidelines for sexually

transmitted diseases issued by the Centers for Disease Control and Prevention.

Efforts outside the United States include those of the World Health

Organization

and the National Institute for Clinical Excellence (NICE), in the United

Kingdom.

Guidelines may be controversial for many reasons; they have been criticized

for recommending too little and for recommending too much. A dramatic

example of political controversy occurred in 1995, when the House of

Representatives voted to effectively stop funding the Agency for Health Care

Policy and

Research; House members had been lobbied by spinal surgeons who objected to

agency-sponsored guidelines for managing acute back problems, which they viewed

as biased against surgical therapy.2 The agency, now called the Agency for

Healthcare Research and Quality (AHRQ), was ultimately preserved, but with a

substantially diminished budget - and it ended its guidelines program, having

issued 19 guidelines between 1992 and 1996. Subsequently, the quality of

guidelines in the fields the agency had covered declined: a RAND study found

that

later guidelines were " of substantially worse methodological quality and

ignore key features important to guideline development. " 3

Other guidelines have been criticized for contradicting dogma or for

providing reasons for insurers to deny coverage for specific drugs or devices.

In

1997, Klausner, then the director of the National Cancer Institute,

and others were outraged when a National Institutes of Health (NIH) consensus

development panel declined to recommend routine mammograms for women in their

40s. Recently, the Infectious Diseases Society of America's guidelines for

diagnosing and treating Lyme disease have been challenged for being overly

restrictive and facilitating the denial of insurance coverage for some

therapies.

Guidelines have also been questioned when pharmaceutical and medical-device

companies with a financial stake in the outcome provide substantial funding

for their development and implementation. When members of guideline

committees also have substantial financial associations with industry, further

questions inevitably arise. Some argue that public disclosure of sponsorship

and of

the financial associations of committee members, along with rules to prevent

sponsors from influencing the selection of panel members and the content of

guidelines, are adequate safeguards. Others maintain that practice

recommendations will invariably be viewed with skepticism unless corporate

sponsorship

and experts with financial ties are completely avoided.

At present, the financial ties between guidelines panels and industry are

extensive. A survey of 685 disclosure statements by authors of guidelines

concerning medications found that 35% declared a potential financial conflict

of

interest.3 In 2006, Eli Lilly was criticized for providing the impetus for

the development of practice guidelines for sepsis treatment and coordinating

the process with a marketing campaign for Xigris (recombinant human activated

protein C). And Amgen and other companies that manufacture or market

recombinant erythropoietin, as well as DaVita, a large company that provides

dialysis

services, have been criticized for their close relations to the development

of the National Kidney Foundation's guidelines for managing anemia in chronic

kidney disease. An alternative approach is government sponsorship, although

it does not ensure that committee members are independent of commercial

interests. In 2004, the National Cholesterol Education Program updated its

guidelines for the detection, evaluation, and treatment of high blood

cholesterol

in adults. It was subsequently disclosed that most of the committee members

had extensive financial connections to the manufacturers of statins, which

stood to gain from increased use of these drugs.

There are various approaches to improving the quality of guidelines and

minimizing the potential for inappropriate influences. Since 1999, NICE

(_www.nice.org.uk_ (http://www.nice.org.uk/) ) has provided guidance on

appropriate

clinical practice within the National Health Service.4 NICE is an independent

organization with an annual budget of about $50 million; between 2003 and

November 2006, it published 39 clinical guidelines, as well as many technology

appraisals and guidance documents for interventional procedures. Some NICE

guidance has been controversial. Recently, for instance, Pfizer and Eisai, a

Japanese biotechnology company, asked a British court to block guidance that

would restrict the use of certain drugs for Alzheimer's disease. The

organization has taken steps to avoid situations arising from potential

conflicts of

interest, requiring members of its advisory bodies to declare their financial

and other interests. According to a 2004 statement from NICE, " if a conflict

of interest is identified, the individuals are required to stand down and do

not take part in the relevant decision-making process for that project. "

In the United States, the NIH Consensus Development Program

(_www.consensus.nih.gov_ (http://www.consensus.nih.gov/) ), which was started

in 1977,

sponsors evidence-based assessments of important medical issues. At present,

each

assessment includes a systematic literature review, prepared through the

AHRQ; a public conference that features research presentations; and a consensus

statement that is disseminated widely. The public conferences use a system of

jurors and witnesses, according to Barry Kramer, the director of the NIH's

Office of Medical Applications of Research, which coordinates the program.

Panel members can have neither financial nor other potential conflicts, and

panels are independent of both the NIH and the Department of Health and Human

Services. The consensus statements reflect the conclusions of the panels, not

those of the institutes. The conference speakers, by contrast, may have

industry ties, but if they do, those ties are disclosed. The process, despite

its

rigor, has limitations. It takes about 18 months from conception to

completion, and each assessment costs about $500,000; only three or four

conferences

are held each year.

Although the AHRQ (_www.ahrq.gov_ (http://www.ahrq.gov/) ) does not prepare

guidelines, it sponsors about 20 to 25 systematic reviews each year. These

reviews provide public and private organizations, such as the Centers for

Medicare and Medicaid Services, the NIH, and specialty societies, with the

scientific foundation for developing and implementing guidelines. Some reviews

compare the effectiveness of drugs or medical tests, such as therapies for low

bone density or noninvasive diagnostic tests for breast abnormalities. The

researchers can have no financial associations related to the subject. The

AHRQ,

however, receives many more proposals for reviews than it can fund.

Medical specialty societies and other professional organizations have

diverse policies for corporate sponsorship of guidelines and the financial

associations of committee members. Some do not allow direct sponsorship,

although

they may accept support for their overall budget. There appears to be a trend

toward more complete disclosure - both to the sponsoring society and to

readers of the guidelines - of financial, personal, and professional

relationships

with industry. Yet little is known about specific practices, such as the

procedures for selecting and supervising panels (are committee chairs and the

officials who select them permitted to have associations with affected

companies?) and the rules for responding to potential conflicts of interest

(including situations in which members must recuse themselves).

Clinical practice guidelines would serve patients and physicians best if

they were prepared with the necessary financial and methodologic support to

ensure their quality; the guidelines would inspire the most confidence if

independent experts developed them without funding from industry or others with

self-interest in the outcome. One approach would be to expand the NIH Consensus

Development Program so that it could take on more subjects. Or Congress might

require that the AHRQ once again support guideline development.

Alternatively, the United States could create its own version of NICE, or a

new agency

to oversee and publish comparisons of the clinical effectiveness of different

treatments and interventions.3,5 To succeed, however, any entity would need

independence and financial security: when powerful interests take issue with

guidelines, challenges will be inevitable.

Source Information

Dr. Steinbrook (_rsteinbrook@..._

(mailto:rsteinbrook@...) ) is a national correspondent for the

Journal.

References

1. Field MJ, Lohr KN, eds. Clinical practice guidelines: directions for

a new program. Washington, DC: National Academy Press, 1990.

1. Deyo RA, Psaty BM, Simon G, Wagner EH, Omenn GS. The messenger under

attack -- intimidation of researchers by special-interest groups. N Engl J

Med 1997;336:1176-1180. [Free Full Text]

1. Hasenfeld R, Shekelle PG. Is the methodological quality of

guidelines declining in the US? Comparison of the quality of US Agency for

Health Care

Policy and Research (AHCPR) guidelines with those published subsequently.

Qual Saf Health Care 2003;12:428-434. [Free Full Text]

1. R, Giles J. Cash interests taint drug advice. Nature

2005;437:1070-1071. [CrossRef][iSI][Medline]

1. Wilensky GR. Developing a center for comparative effectiveness

information. Health Aff (Millwood) 2006;25:w572-w585. [Free Full Text]

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[Guest guest]

Sharon,

Excellent resource. Makes much more sense both idealistically and

practically than the bombastic absolutisms we've seen from other

sources. I'm going to include this as an outline to the IESO for

their upcoming start at writing standards for the indoor environment.

Carl Grimes

Healthy Habitats LLC

-----

>

> Guidance for Guidelines

> Steinbrook, M.D.

>

>

>

>

>

> Clinical practice guidelines are systematically developed statements that

> aim to help physicians and patients reach the best health care decisions.

Good

> guidelines have many attributes, including validity, reliability,

> reproducibility, clinical applicability and flexibility, clarity, development

through a

> multidisciplinary process, scheduled reviews, and documentation.1 More than

> 2000 guidelines are currently represented in the National Guideline

> Clearinghouse (_www.guideline.gov_ (http://www.guideline.gov/) ). Medical

specialty

> societies are their most common sponsors.

>

>

>

> Guidelines rely on both evidence and opinion; they are neither infallible

> nor a substitute for clinical judgment. They do, however, go beyond

systematic

> reviews to recommend what should and should not be done in specific clinical

> circumstances. Some are widely respected; they have helped to standardize

> care, diminish local variation, and improve health outcomes. However, the

> quality of guidelines varies considerably. Among the efforts in the United

States

> that are generally considered successful are those of the U.S. Preventive

> Services Task Force, the Advisory Committee on Immunization Practices, and

the

> National Academies, as well as the treatment guidelines for sexually

> transmitted diseases issued by the Centers for Disease Control and

Prevention.

> Efforts outside the United States include those of the World Health

Organization

> and the National Institute for Clinical Excellence (NICE), in the United

> Kingdom.

>

> Guidelines may be controversial for many reasons; they have been criticized

> for recommending too little and for recommending too much. A dramatic

> example of political controversy occurred in 1995, when the House of

> Representatives voted to effectively stop funding the Agency for Health Care

Policy and

> Research; House members had been lobbied by spinal surgeons who objected to

> agency-sponsored guidelines for managing acute back problems, which they

viewed

> as biased against surgical therapy.2 The agency, now called the Agency for

> Healthcare Research and Quality (AHRQ), was ultimately preserved, but with a

> substantially diminished budget - and it ended its guidelines program, having

> issued 19 guidelines between 1992 and 1996. Subsequently, the quality of

> guidelines in the fields the agency had covered declined: a RAND study found

that

> later guidelines were " of substantially worse methodological quality and

> ignore key features important to guideline development. " 3

> Other guidelines have been criticized for contradicting dogma or for

> providing reasons for insurers to deny coverage for specific drugs or

devices. In

> 1997, Klausner, then the director of the National Cancer Institute,

> and others were outraged when a National Institutes of Health (NIH) consensus

> development panel declined to recommend routine mammograms for women in their

> 40s. Recently, the Infectious Diseases Society of America's guidelines for

> diagnosing and treating Lyme disease have been challenged for being overly

> restrictive and facilitating the denial of insurance coverage for some

therapies.

>

> Guidelines have also been questioned when pharmaceutical and medical-device

> companies with a financial stake in the outcome provide substantial funding

> for their development and implementation. When members of guideline

> committees also have substantial financial associations with industry,

further

> questions inevitably arise. Some argue that public disclosure of sponsorship

and of

> the financial associations of committee members, along with rules to prevent

> sponsors from influencing the selection of panel members and the content of

> guidelines, are adequate safeguards. Others maintain that practice

> recommendations will invariably be viewed with skepticism unless corporate

sponsorship

> and experts with financial ties are completely avoided.

> At present, the financial ties between guidelines panels and industry are

> extensive. A survey of 685 disclosure statements by authors of guidelines

> concerning medications found that 35% declared a potential financial conflict

of

> interest.3 In 2006, Eli Lilly was criticized for providing the impetus for

> the development of practice guidelines for sepsis treatment and coordinating

> the process with a marketing campaign for Xigris (recombinant human activated

> protein C). And Amgen and other companies that manufacture or market

> recombinant erythropoietin, as well as DaVita, a large company that provides

dialysis

> services, have been criticized for their close relations to the development

> of the National Kidney Foundation's guidelines for managing anemia in chronic

> kidney disease. An alternative approach is government sponsorship, although

> it does not ensure that committee members are independent of commercial

> interests. In 2004, the National Cholesterol Education Program updated its

> guidelines for the detection, evaluation, and treatment of high blood

cholesterol

> in adults. It was subsequently disclosed that most of the committee members

> had extensive financial connections to the manufacturers of statins, which

> stood to gain from increased use of these drugs.

> There are various approaches to improving the quality of guidelines and

> minimizing the potential for inappropriate influences. Since 1999, NICE

> (_www.nice.org.uk_ (http://www.nice.org.uk/) ) has provided guidance on

appropriate

> clinical practice within the National Health Service.4 NICE is an independent

> organization with an annual budget of about $50 million; between 2003 and

> November 2006, it published 39 clinical guidelines, as well as many

technology

> appraisals and guidance documents for interventional procedures. Some NICE

> guidance has been controversial. Recently, for instance, Pfizer and Eisai, a

> Japanese biotechnology company, asked a British court to block guidance that

> would restrict the use of certain drugs for Alzheimer's disease. The

> organization has taken steps to avoid situations arising from potential

conflicts of

> interest, requiring members of its advisory bodies to declare their financial

> and other interests. According to a 2004 statement from NICE, " if a conflict

> of interest is identified, the individuals are required to stand down and do

> not take part in the relevant decision-making process for that project. "

> In the United States, the NIH Consensus Development Program

> (_www.consensus.nih.gov_ (http://www.consensus.nih.gov/) ), which was started

in 1977,

> sponsors evidence-based assessments of important medical issues. At present,

each

> assessment includes a systematic literature review, prepared through the

> AHRQ; a public conference that features research presentations; and a

consensus

> statement that is disseminated widely. The public conferences use a system of

> jurors and witnesses, according to Barry Kramer, the director of the NIH's

> Office of Medical Applications of Research, which coordinates the program.

> Panel members can have neither financial nor other potential conflicts, and

> panels are independent of both the NIH and the Department of Health and Human

> Services. The consensus statements reflect the conclusions of the panels, not

> those of the institutes. The conference speakers, by contrast, may have

> industry ties, but if they do, those ties are disclosed. The process,

despite its

> rigor, has limitations. It takes about 18 months from conception to

> completion, and each assessment costs about $500,000; only three or four

conferences

> are held each year.

> Although the AHRQ (_www.ahrq.gov_ (http://www.ahrq.gov/) ) does not prepare

> guidelines, it sponsors about 20 to 25 systematic reviews each year. These

> reviews provide public and private organizations, such as the Centers for

> Medicare and Medicaid Services, the NIH, and specialty societies, with the

> scientific foundation for developing and implementing guidelines. Some

reviews

> compare the effectiveness of drugs or medical tests, such as therapies for

low

> bone density or noninvasive diagnostic tests for breast abnormalities. The

> researchers can have no financial associations related to the subject. The

AHRQ,

> however, receives many more proposals for reviews than it can fund.

> Medical specialty societies and other professional organizations have

> diverse policies for corporate sponsorship of guidelines and the financial

> associations of committee members. Some do not allow direct sponsorship,

although

> they may accept support for their overall budget. There appears to be a trend

> toward more complete disclosure - both to the sponsoring society and to

> readers of the guidelines - of financial, personal, and professional

relationships

> with industry. Yet little is known about specific practices, such as the

> procedures for selecting and supervising panels (are committee chairs and the

> officials who select them permitted to have associations with affected

> companies?) and the rules for responding to potential conflicts of interest

> (including situations in which members must recuse themselves).

> Clinical practice guidelines would serve patients and physicians best if

> they were prepared with the necessary financial and methodologic support to

> ensure their quality; the guidelines would inspire the most confidence if

> independent experts developed them without funding from industry or others

with

> self-interest in the outcome. One approach would be to expand the NIH

Consensus

> Development Program so that it could take on more subjects. Or Congress might

> require that the AHRQ once again support guideline development.

> Alternatively, the United States could create its own version of NICE, or a

new agency

> to oversee and publish comparisons of the clinical effectiveness of different

> treatments and interventions.3,5 To succeed, however, any entity would need

> independence and financial security: when powerful interests take issue with

> guidelines, challenges will be inevitable.

>

> Source Information

> Dr. Steinbrook (_rsteinbrook@..._

> (mailto:rsteinbrook@...) ) is a national correspondent for the

Journal.

>

> References

> 1. Field MJ, Lohr KN, eds. Clinical practice guidelines: directions for

> a new program. Washington, DC: National Academy Press, 1990.

> 1. Deyo RA, Psaty BM, Simon G, Wagner EH, Omenn GS. The messenger under

> attack -- intimidation of researchers by special-interest groups. N Engl J

> Med 1997;336:1176-1180. [Free Full Text]

> 1. Hasenfeld R, Shekelle PG. Is the methodological quality of

> guidelines declining in the US? Comparison of the quality of US Agency for

Health Care

> Policy and Research (AHCPR) guidelines with those published subsequently.

> Qual Saf Health Care 2003;12:428-434. [Free Full Text]

> 1. R, Giles J. Cash interests taint drug advice. Nature

> 2005;437:1070-1071. [CrossRef][iSI][Medline]

> 1. Wilensky GR. Developing a center for comparative effectiveness

> information. Health Aff (Millwood) 2006;25:w572-w585. [Free Full Text]

> <BR><BR><BR>**************************************<BR> AOL now offers free

> email to everyone. Find out more about what's free from AOL at

> http://www.aol.com.

>

>

>