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Evidence-based medicine: How it becomes a 4-letter word
One day a residency program decided to put its evidence-based medicine (EBM) curriculum to good use. A group of faculty and residents conducted a thorough review of the evidence regarding liquid-based cytoloutilizegy vs conventional Pap smears. They identified the key national recommendations and reviewed the supporting evidence behind each recommendation, tracing back to the individual studies themselves.1-3
Based on the review, the group concluded that there was insufficient evidence to recommend one method of screening over another, but that there were situations in which one method might be preferred. They presented the evidence and their conclusions to the majority of faculty and residents at grand rounds. Following the presentation, the larger group discussed the relative merits of each screening method and decided the elements of evidence that supported the liquid test were more relevant to the practice than the conventional Pap smear. As a result, a decision was made by the group to stop carrying supplies for the conventional Pap smear. While the decision seemed reasonable on the level of an individual practitioner, several faculty and residents were unhappy with the “evidence-based” decision.
KAP theory and EBM
KAP theory identifies Knowledge, Attitudes, and Practice beliefs as key elements that drive healthcare providers’ decisions about medical care. In a sense EBM represents knowledge.4 There is a collective body of medical knowledge in the form of research, which represents “the evidence.” And there is what the healthcare provider himself “knows.” A major purpose of healthcare recommendations, point of care information systems, and best practice guidelines is to help the healthcare provider’s individual medical knowledge reflect the collective body of evidence.
For the purposes of this example, evidence will be considered absolute, inadequate, conditional, or relative. Absolute evidence occurs when there is clearly a correct answer. For example, the net benefits of aspirin for the treatment of myocardial infarction are clear. However, for most topics the evidence is not absolute; rather, it is inconclusive.5 The evidence may be inconclusive because it is inadequate—eg, insufficient research, conflicting studies, or research on peripheral topics. As an example, studies have demonstrated that aspirin decreases colorectal polyps, which may or may not be peripheral to the question of whether aspirin prevents colorectal cancer.
The evidence can also be conditional, meaning that in some defined instances the net benefit is clear. However, extending this net benefit beyond these instances is less clear. For example, patients at high risk for cardiovascular disease have a clear net benefit in taking aspirin for myocardial infarction prevention. Finally, the evidence may be relative, with a balance of known benefits and known risks.6 Using the aspirin example for cardiovascular disease prevention, patients at moderate risk receive benefit from aspirin in preventing myocardial infarction but at a risk cost of increased bleeding.
When the evidence is inconclusive, the second and third aspects of KAP theory—attitudes and practice beliefs—become very important. Healthcare providers and patients may arrive at different conclusions based on different viewpoints. On an individual level, healthcare practitioners use tools such as shared decision-making and patient-centered care to reach decisions.6,7 However, inconclusive evidence provides a unique challenge when trying to develop local, regional, or national standards.
Evidence heresy
EBM frequently has negative connotations. In a room full of healthcare providers, some will believe that EBM should revolutionize the practice of medicine,8 and some that EBM has limited utility.9 How does this happen? The above scenario serves as a useful example, highlighting 3 misuses of the term “evidence” that frequently give EBM a bad name.
First, inconclusive evidence should not be stated in absolute terms; rather, it is more helpful to explicitly state what we know and the limits of what we know. Shaughnessy and Slawson wrote, “Absolute certainty is absolutely impossible, and we do not have to wait for that, of course.”10 This reflects the paucity of topics with certain evidence and highlights the need for clinicians to act on the available information. Every clinician necessarily utilizes this skill on a daily basis. The clinician has to become an Information Master11 and know not only the end result of what the evidence indicates but also the facts supporting the end results and how those facts apply to the care of an unique individual.12 However, taking this a step further and stating that one answer or option is absolutely correct in all cases ventures into dangerous ground. During the residency’s discussion of cervical cancer screening tests, the group recognized the merits of both options verbally but, the act of removing all conventional Pap smear supplies implied the nonverbal judgment that liquid-based technology was an absolute correct answer.
Second, while attitudes and practice beliefs can be used to weigh elements of evidence to reach a final conclusion, the conclusion should not negate other perspectives. An important skill of an adept clinician is the ability to interweave the healthcare provider’s and the patient’s attitudes and practice beliefs into the body of existing evidence to determine the appropriate intervention.13 However, attitudes and practice beliefs vary from individual to individual and from community to community. When these factors play a critical role in defining the appropriate action based on the evidence, how attitudes and practice beliefs are used should be explicitly stated. In the Pap smear example, the pivotal issue of contention was the belief about whether individual practitioners should act as stewards of limited healthcare resources. Proponents of using solely the liquid-based Pap smear felt the cost problem was a national issue and that the actions of the individual clinician had little impact on global healthcare costs. Others felt their local actions affected insurance premiums, leading directly to decreased healthcare access.11 For cervical cancer, the key impact on mortality is getting any form of screening.1 Using the liquid-based method for low-risk women may increase cervical cancer mortality by increasing costs and decreasing healthcare access. Removing conventional Pap smears disempowered the latter group of clinicians from implementing their practice beliefs and attitudes.
Finally, a conclusion should not be labeled as “evidence-based” when it is really made on other grounds such as economics, law, ethics, convenience, social values, or policy. Certainly, reviewing medical evidence is an important step in making decisions. However, the process for making decisions on these factors should be held to the same standards as making medical evidence decisions. This includes defining the process and explicitly stating the basis by which final decision will be made. The US is very conflicted when it comes to dealing with these non-evidence issues. We have no national standard for incorporating costs into healthcare decisions.14,15 With respect to healthcare delivery, we have a wide range of social values that are sometimes disproportionate to logical expectations.16 Few effective systems are in place to incorporate these elements in healthcare decisions and, as a result, “evidence” is often used as a code word to focus on other issues.
For the Pap smear example, the decision factors were really economics, law, and systems of care. Proponents of the liquid-based method cited the community standard of care, fear of malpractice, patient expectations of receiving the latest technology, and the ease of adopting one screening method for the entire office. Others felt these issues, although important, were secondary to the lack of evidence supporting a liquid-based system as a sole screening method. For lowrisk women, adopting the liquid-based method only makes economic sense if screening is done every 2 or 3 years.17 However, many low-risk women still favor performing a Pap smear annually.18 As a result a decision-making process other than the strict EBM method, focusing on other factors would be necessary to change the practice standard.
Conclusions: Recognize the limitations of EBM
Cervical cancer screening serves as a common example of a difficult decision healthcare providers are faced with on a daily basis—what to do when evidence, based on patient oriented outcomes, is inconclusive. Providers do not have the luxury of merely stating the evidence is inconclusive; they must act. Frequently decisions are based on attitudes and practice beliefs in a broader context of unique economic, legal, and practice environments.
EBM is one tool in the decision-making armamentarium. It is a very powerful tool and has had a very positive impact on healthcare. Its methods have been well defined and explicitly stated. However, failing to recognize its limitations and making a decision under the rubric of EBM, when other variables are clearly playing a role, perpetuates the perception of its limited utility. Advocates of EBM need to wield this instrument carefully and judiciously.
CORRESPONDENCE
Alex Krist, MD, 3825 Charles Stewart Drive, Fairfax VA 22033. E-mail: [email protected]
1. US Preventive Services Task Force. Screening for Cervical Cancer. 2003. Available at: www.ahrq.gov/clinic/uspstf/uspscerv.htm. Accessed June 13, 2005.
2. Saslow D, Runowicz CD, Solomon D, et al. American Cancer Society guideline for the early detection of cervical neoplasia and cancer. CA Cancer J Clin 2002;52:342-362.
3. American College of Obstetricians and Gynecologists. Guidelines for Women’s Health Care. 2nd ed. Washington, DC: ACOG; 2002.
4. Glanz K, Lewis FM, Rimer B. Health Behavior and Health Education. 2nd ed. San Francisco: Jossey-Bass; 1997.
5. Harris RP, Helfand M, Woolf SH, et al. Current methods of the US Preventive Services Task Force: a review of the process. Am J Prev Med 2001;20(3 Suppl):21-35.
6. Sheridan SL, Harris RP, Woolf SH. Shared decision making about screening and chemoprevention. a suggested approach from the US Preventive Services Task Force. Am J Prev Med 2004;26:56-66.
7. Stewart M, Brown JB, Weston WW, McWhinney IR, McWilliam CL, Freeman TR. Patient-Centered Medicine: Transforming the Clinical Method. Thousand Oaks, Calif: Sage Publications; 1995.
8. Shaughnessy AF, Slawson DC. POEMs: patient-oriented evidence that matters. Ann Intern Med 1997;126:667.-
9. Cohen AM, Stavri PZ, Hersh WR. A categorization and analysis of the criticisms of Evidence. Based Medicine. Int J Med Inf 2004;73:35-43.
10. Shaughnessy AF, Slawson DC. An evidence-based approach to medical care raises uncomfortable questions. J Fam Pract 2000;49:1089-1090.
11. Slawson DC, Shaughnessy AF. Becoming an information master: using “medical poetry” to remove the inequities in health care delivery. J Fam Pract 2001;50:51-56.
12. Shaughnessy AF, Slawson DC, Becker L. Clinical jazz: harmonizing clinical experience and evidence-based medicine. J Fam Pract 1998;47:425-428.
13. Kenny NP. Does good science make good medicine? Incorporating evidence into practice is complicated by the fact that clinical practice is as much art as science. CMAJ 1997;157:33-36.
14. Gillick MR. Medicare coverage for technological innovations—time for new criteria? N Engl J Med 2004;350:2199-2203.
15. Tunis SR. Why Medicare has not established criteria for coverage decisions. N Engl J Med 2004;350:2196-2198.
16. Schwartz LM, Woloshin S, Fowler FJ,, Jr, Welch HG. Enthusiasm for cancer screening in the United States. JAMA 2004;291:71-78.
17. Karnon J, Peters J, Platt J, Chilcott J, McGoogan E, Brewer N. Liquid-based cytology in cervical screening: an updated rapid and systematic review and economic analysis. Health Technol Assess 2004;8:iii, 1-78.
18. Smith M, French L, Barry HC. Periodic abstinence from Pap (PAP) smear study: women’s perceptions of Pap smear screening. Ann Fam Med 2003;1:203-208.
One day a residency program decided to put its evidence-based medicine (EBM) curriculum to good use. A group of faculty and residents conducted a thorough review of the evidence regarding liquid-based cytoloutilizegy vs conventional Pap smears. They identified the key national recommendations and reviewed the supporting evidence behind each recommendation, tracing back to the individual studies themselves.1-3
Based on the review, the group concluded that there was insufficient evidence to recommend one method of screening over another, but that there were situations in which one method might be preferred. They presented the evidence and their conclusions to the majority of faculty and residents at grand rounds. Following the presentation, the larger group discussed the relative merits of each screening method and decided the elements of evidence that supported the liquid test were more relevant to the practice than the conventional Pap smear. As a result, a decision was made by the group to stop carrying supplies for the conventional Pap smear. While the decision seemed reasonable on the level of an individual practitioner, several faculty and residents were unhappy with the “evidence-based” decision.
KAP theory and EBM
KAP theory identifies Knowledge, Attitudes, and Practice beliefs as key elements that drive healthcare providers’ decisions about medical care. In a sense EBM represents knowledge.4 There is a collective body of medical knowledge in the form of research, which represents “the evidence.” And there is what the healthcare provider himself “knows.” A major purpose of healthcare recommendations, point of care information systems, and best practice guidelines is to help the healthcare provider’s individual medical knowledge reflect the collective body of evidence.
For the purposes of this example, evidence will be considered absolute, inadequate, conditional, or relative. Absolute evidence occurs when there is clearly a correct answer. For example, the net benefits of aspirin for the treatment of myocardial infarction are clear. However, for most topics the evidence is not absolute; rather, it is inconclusive.5 The evidence may be inconclusive because it is inadequate—eg, insufficient research, conflicting studies, or research on peripheral topics. As an example, studies have demonstrated that aspirin decreases colorectal polyps, which may or may not be peripheral to the question of whether aspirin prevents colorectal cancer.
The evidence can also be conditional, meaning that in some defined instances the net benefit is clear. However, extending this net benefit beyond these instances is less clear. For example, patients at high risk for cardiovascular disease have a clear net benefit in taking aspirin for myocardial infarction prevention. Finally, the evidence may be relative, with a balance of known benefits and known risks.6 Using the aspirin example for cardiovascular disease prevention, patients at moderate risk receive benefit from aspirin in preventing myocardial infarction but at a risk cost of increased bleeding.
When the evidence is inconclusive, the second and third aspects of KAP theory—attitudes and practice beliefs—become very important. Healthcare providers and patients may arrive at different conclusions based on different viewpoints. On an individual level, healthcare practitioners use tools such as shared decision-making and patient-centered care to reach decisions.6,7 However, inconclusive evidence provides a unique challenge when trying to develop local, regional, or national standards.
Evidence heresy
EBM frequently has negative connotations. In a room full of healthcare providers, some will believe that EBM should revolutionize the practice of medicine,8 and some that EBM has limited utility.9 How does this happen? The above scenario serves as a useful example, highlighting 3 misuses of the term “evidence” that frequently give EBM a bad name.
First, inconclusive evidence should not be stated in absolute terms; rather, it is more helpful to explicitly state what we know and the limits of what we know. Shaughnessy and Slawson wrote, “Absolute certainty is absolutely impossible, and we do not have to wait for that, of course.”10 This reflects the paucity of topics with certain evidence and highlights the need for clinicians to act on the available information. Every clinician necessarily utilizes this skill on a daily basis. The clinician has to become an Information Master11 and know not only the end result of what the evidence indicates but also the facts supporting the end results and how those facts apply to the care of an unique individual.12 However, taking this a step further and stating that one answer or option is absolutely correct in all cases ventures into dangerous ground. During the residency’s discussion of cervical cancer screening tests, the group recognized the merits of both options verbally but, the act of removing all conventional Pap smear supplies implied the nonverbal judgment that liquid-based technology was an absolute correct answer.
Second, while attitudes and practice beliefs can be used to weigh elements of evidence to reach a final conclusion, the conclusion should not negate other perspectives. An important skill of an adept clinician is the ability to interweave the healthcare provider’s and the patient’s attitudes and practice beliefs into the body of existing evidence to determine the appropriate intervention.13 However, attitudes and practice beliefs vary from individual to individual and from community to community. When these factors play a critical role in defining the appropriate action based on the evidence, how attitudes and practice beliefs are used should be explicitly stated. In the Pap smear example, the pivotal issue of contention was the belief about whether individual practitioners should act as stewards of limited healthcare resources. Proponents of using solely the liquid-based Pap smear felt the cost problem was a national issue and that the actions of the individual clinician had little impact on global healthcare costs. Others felt their local actions affected insurance premiums, leading directly to decreased healthcare access.11 For cervical cancer, the key impact on mortality is getting any form of screening.1 Using the liquid-based method for low-risk women may increase cervical cancer mortality by increasing costs and decreasing healthcare access. Removing conventional Pap smears disempowered the latter group of clinicians from implementing their practice beliefs and attitudes.
Finally, a conclusion should not be labeled as “evidence-based” when it is really made on other grounds such as economics, law, ethics, convenience, social values, or policy. Certainly, reviewing medical evidence is an important step in making decisions. However, the process for making decisions on these factors should be held to the same standards as making medical evidence decisions. This includes defining the process and explicitly stating the basis by which final decision will be made. The US is very conflicted when it comes to dealing with these non-evidence issues. We have no national standard for incorporating costs into healthcare decisions.14,15 With respect to healthcare delivery, we have a wide range of social values that are sometimes disproportionate to logical expectations.16 Few effective systems are in place to incorporate these elements in healthcare decisions and, as a result, “evidence” is often used as a code word to focus on other issues.
For the Pap smear example, the decision factors were really economics, law, and systems of care. Proponents of the liquid-based method cited the community standard of care, fear of malpractice, patient expectations of receiving the latest technology, and the ease of adopting one screening method for the entire office. Others felt these issues, although important, were secondary to the lack of evidence supporting a liquid-based system as a sole screening method. For lowrisk women, adopting the liquid-based method only makes economic sense if screening is done every 2 or 3 years.17 However, many low-risk women still favor performing a Pap smear annually.18 As a result a decision-making process other than the strict EBM method, focusing on other factors would be necessary to change the practice standard.
Conclusions: Recognize the limitations of EBM
Cervical cancer screening serves as a common example of a difficult decision healthcare providers are faced with on a daily basis—what to do when evidence, based on patient oriented outcomes, is inconclusive. Providers do not have the luxury of merely stating the evidence is inconclusive; they must act. Frequently decisions are based on attitudes and practice beliefs in a broader context of unique economic, legal, and practice environments.
EBM is one tool in the decision-making armamentarium. It is a very powerful tool and has had a very positive impact on healthcare. Its methods have been well defined and explicitly stated. However, failing to recognize its limitations and making a decision under the rubric of EBM, when other variables are clearly playing a role, perpetuates the perception of its limited utility. Advocates of EBM need to wield this instrument carefully and judiciously.
CORRESPONDENCE
Alex Krist, MD, 3825 Charles Stewart Drive, Fairfax VA 22033. E-mail: [email protected]
One day a residency program decided to put its evidence-based medicine (EBM) curriculum to good use. A group of faculty and residents conducted a thorough review of the evidence regarding liquid-based cytoloutilizegy vs conventional Pap smears. They identified the key national recommendations and reviewed the supporting evidence behind each recommendation, tracing back to the individual studies themselves.1-3
Based on the review, the group concluded that there was insufficient evidence to recommend one method of screening over another, but that there were situations in which one method might be preferred. They presented the evidence and their conclusions to the majority of faculty and residents at grand rounds. Following the presentation, the larger group discussed the relative merits of each screening method and decided the elements of evidence that supported the liquid test were more relevant to the practice than the conventional Pap smear. As a result, a decision was made by the group to stop carrying supplies for the conventional Pap smear. While the decision seemed reasonable on the level of an individual practitioner, several faculty and residents were unhappy with the “evidence-based” decision.
KAP theory and EBM
KAP theory identifies Knowledge, Attitudes, and Practice beliefs as key elements that drive healthcare providers’ decisions about medical care. In a sense EBM represents knowledge.4 There is a collective body of medical knowledge in the form of research, which represents “the evidence.” And there is what the healthcare provider himself “knows.” A major purpose of healthcare recommendations, point of care information systems, and best practice guidelines is to help the healthcare provider’s individual medical knowledge reflect the collective body of evidence.
For the purposes of this example, evidence will be considered absolute, inadequate, conditional, or relative. Absolute evidence occurs when there is clearly a correct answer. For example, the net benefits of aspirin for the treatment of myocardial infarction are clear. However, for most topics the evidence is not absolute; rather, it is inconclusive.5 The evidence may be inconclusive because it is inadequate—eg, insufficient research, conflicting studies, or research on peripheral topics. As an example, studies have demonstrated that aspirin decreases colorectal polyps, which may or may not be peripheral to the question of whether aspirin prevents colorectal cancer.
The evidence can also be conditional, meaning that in some defined instances the net benefit is clear. However, extending this net benefit beyond these instances is less clear. For example, patients at high risk for cardiovascular disease have a clear net benefit in taking aspirin for myocardial infarction prevention. Finally, the evidence may be relative, with a balance of known benefits and known risks.6 Using the aspirin example for cardiovascular disease prevention, patients at moderate risk receive benefit from aspirin in preventing myocardial infarction but at a risk cost of increased bleeding.
When the evidence is inconclusive, the second and third aspects of KAP theory—attitudes and practice beliefs—become very important. Healthcare providers and patients may arrive at different conclusions based on different viewpoints. On an individual level, healthcare practitioners use tools such as shared decision-making and patient-centered care to reach decisions.6,7 However, inconclusive evidence provides a unique challenge when trying to develop local, regional, or national standards.
Evidence heresy
EBM frequently has negative connotations. In a room full of healthcare providers, some will believe that EBM should revolutionize the practice of medicine,8 and some that EBM has limited utility.9 How does this happen? The above scenario serves as a useful example, highlighting 3 misuses of the term “evidence” that frequently give EBM a bad name.
First, inconclusive evidence should not be stated in absolute terms; rather, it is more helpful to explicitly state what we know and the limits of what we know. Shaughnessy and Slawson wrote, “Absolute certainty is absolutely impossible, and we do not have to wait for that, of course.”10 This reflects the paucity of topics with certain evidence and highlights the need for clinicians to act on the available information. Every clinician necessarily utilizes this skill on a daily basis. The clinician has to become an Information Master11 and know not only the end result of what the evidence indicates but also the facts supporting the end results and how those facts apply to the care of an unique individual.12 However, taking this a step further and stating that one answer or option is absolutely correct in all cases ventures into dangerous ground. During the residency’s discussion of cervical cancer screening tests, the group recognized the merits of both options verbally but, the act of removing all conventional Pap smear supplies implied the nonverbal judgment that liquid-based technology was an absolute correct answer.
Second, while attitudes and practice beliefs can be used to weigh elements of evidence to reach a final conclusion, the conclusion should not negate other perspectives. An important skill of an adept clinician is the ability to interweave the healthcare provider’s and the patient’s attitudes and practice beliefs into the body of existing evidence to determine the appropriate intervention.13 However, attitudes and practice beliefs vary from individual to individual and from community to community. When these factors play a critical role in defining the appropriate action based on the evidence, how attitudes and practice beliefs are used should be explicitly stated. In the Pap smear example, the pivotal issue of contention was the belief about whether individual practitioners should act as stewards of limited healthcare resources. Proponents of using solely the liquid-based Pap smear felt the cost problem was a national issue and that the actions of the individual clinician had little impact on global healthcare costs. Others felt their local actions affected insurance premiums, leading directly to decreased healthcare access.11 For cervical cancer, the key impact on mortality is getting any form of screening.1 Using the liquid-based method for low-risk women may increase cervical cancer mortality by increasing costs and decreasing healthcare access. Removing conventional Pap smears disempowered the latter group of clinicians from implementing their practice beliefs and attitudes.
Finally, a conclusion should not be labeled as “evidence-based” when it is really made on other grounds such as economics, law, ethics, convenience, social values, or policy. Certainly, reviewing medical evidence is an important step in making decisions. However, the process for making decisions on these factors should be held to the same standards as making medical evidence decisions. This includes defining the process and explicitly stating the basis by which final decision will be made. The US is very conflicted when it comes to dealing with these non-evidence issues. We have no national standard for incorporating costs into healthcare decisions.14,15 With respect to healthcare delivery, we have a wide range of social values that are sometimes disproportionate to logical expectations.16 Few effective systems are in place to incorporate these elements in healthcare decisions and, as a result, “evidence” is often used as a code word to focus on other issues.
For the Pap smear example, the decision factors were really economics, law, and systems of care. Proponents of the liquid-based method cited the community standard of care, fear of malpractice, patient expectations of receiving the latest technology, and the ease of adopting one screening method for the entire office. Others felt these issues, although important, were secondary to the lack of evidence supporting a liquid-based system as a sole screening method. For lowrisk women, adopting the liquid-based method only makes economic sense if screening is done every 2 or 3 years.17 However, many low-risk women still favor performing a Pap smear annually.18 As a result a decision-making process other than the strict EBM method, focusing on other factors would be necessary to change the practice standard.
Conclusions: Recognize the limitations of EBM
Cervical cancer screening serves as a common example of a difficult decision healthcare providers are faced with on a daily basis—what to do when evidence, based on patient oriented outcomes, is inconclusive. Providers do not have the luxury of merely stating the evidence is inconclusive; they must act. Frequently decisions are based on attitudes and practice beliefs in a broader context of unique economic, legal, and practice environments.
EBM is one tool in the decision-making armamentarium. It is a very powerful tool and has had a very positive impact on healthcare. Its methods have been well defined and explicitly stated. However, failing to recognize its limitations and making a decision under the rubric of EBM, when other variables are clearly playing a role, perpetuates the perception of its limited utility. Advocates of EBM need to wield this instrument carefully and judiciously.
CORRESPONDENCE
Alex Krist, MD, 3825 Charles Stewart Drive, Fairfax VA 22033. E-mail: [email protected]
1. US Preventive Services Task Force. Screening for Cervical Cancer. 2003. Available at: www.ahrq.gov/clinic/uspstf/uspscerv.htm. Accessed June 13, 2005.
2. Saslow D, Runowicz CD, Solomon D, et al. American Cancer Society guideline for the early detection of cervical neoplasia and cancer. CA Cancer J Clin 2002;52:342-362.
3. American College of Obstetricians and Gynecologists. Guidelines for Women’s Health Care. 2nd ed. Washington, DC: ACOG; 2002.
4. Glanz K, Lewis FM, Rimer B. Health Behavior and Health Education. 2nd ed. San Francisco: Jossey-Bass; 1997.
5. Harris RP, Helfand M, Woolf SH, et al. Current methods of the US Preventive Services Task Force: a review of the process. Am J Prev Med 2001;20(3 Suppl):21-35.
6. Sheridan SL, Harris RP, Woolf SH. Shared decision making about screening and chemoprevention. a suggested approach from the US Preventive Services Task Force. Am J Prev Med 2004;26:56-66.
7. Stewart M, Brown JB, Weston WW, McWhinney IR, McWilliam CL, Freeman TR. Patient-Centered Medicine: Transforming the Clinical Method. Thousand Oaks, Calif: Sage Publications; 1995.
8. Shaughnessy AF, Slawson DC. POEMs: patient-oriented evidence that matters. Ann Intern Med 1997;126:667.-
9. Cohen AM, Stavri PZ, Hersh WR. A categorization and analysis of the criticisms of Evidence. Based Medicine. Int J Med Inf 2004;73:35-43.
10. Shaughnessy AF, Slawson DC. An evidence-based approach to medical care raises uncomfortable questions. J Fam Pract 2000;49:1089-1090.
11. Slawson DC, Shaughnessy AF. Becoming an information master: using “medical poetry” to remove the inequities in health care delivery. J Fam Pract 2001;50:51-56.
12. Shaughnessy AF, Slawson DC, Becker L. Clinical jazz: harmonizing clinical experience and evidence-based medicine. J Fam Pract 1998;47:425-428.
13. Kenny NP. Does good science make good medicine? Incorporating evidence into practice is complicated by the fact that clinical practice is as much art as science. CMAJ 1997;157:33-36.
14. Gillick MR. Medicare coverage for technological innovations—time for new criteria? N Engl J Med 2004;350:2199-2203.
15. Tunis SR. Why Medicare has not established criteria for coverage decisions. N Engl J Med 2004;350:2196-2198.
16. Schwartz LM, Woloshin S, Fowler FJ,, Jr, Welch HG. Enthusiasm for cancer screening in the United States. JAMA 2004;291:71-78.
17. Karnon J, Peters J, Platt J, Chilcott J, McGoogan E, Brewer N. Liquid-based cytology in cervical screening: an updated rapid and systematic review and economic analysis. Health Technol Assess 2004;8:iii, 1-78.
18. Smith M, French L, Barry HC. Periodic abstinence from Pap (PAP) smear study: women’s perceptions of Pap smear screening. Ann Fam Med 2003;1:203-208.
1. US Preventive Services Task Force. Screening for Cervical Cancer. 2003. Available at: www.ahrq.gov/clinic/uspstf/uspscerv.htm. Accessed June 13, 2005.
2. Saslow D, Runowicz CD, Solomon D, et al. American Cancer Society guideline for the early detection of cervical neoplasia and cancer. CA Cancer J Clin 2002;52:342-362.
3. American College of Obstetricians and Gynecologists. Guidelines for Women’s Health Care. 2nd ed. Washington, DC: ACOG; 2002.
4. Glanz K, Lewis FM, Rimer B. Health Behavior and Health Education. 2nd ed. San Francisco: Jossey-Bass; 1997.
5. Harris RP, Helfand M, Woolf SH, et al. Current methods of the US Preventive Services Task Force: a review of the process. Am J Prev Med 2001;20(3 Suppl):21-35.
6. Sheridan SL, Harris RP, Woolf SH. Shared decision making about screening and chemoprevention. a suggested approach from the US Preventive Services Task Force. Am J Prev Med 2004;26:56-66.
7. Stewart M, Brown JB, Weston WW, McWhinney IR, McWilliam CL, Freeman TR. Patient-Centered Medicine: Transforming the Clinical Method. Thousand Oaks, Calif: Sage Publications; 1995.
8. Shaughnessy AF, Slawson DC. POEMs: patient-oriented evidence that matters. Ann Intern Med 1997;126:667.-
9. Cohen AM, Stavri PZ, Hersh WR. A categorization and analysis of the criticisms of Evidence. Based Medicine. Int J Med Inf 2004;73:35-43.
10. Shaughnessy AF, Slawson DC. An evidence-based approach to medical care raises uncomfortable questions. J Fam Pract 2000;49:1089-1090.
11. Slawson DC, Shaughnessy AF. Becoming an information master: using “medical poetry” to remove the inequities in health care delivery. J Fam Pract 2001;50:51-56.
12. Shaughnessy AF, Slawson DC, Becker L. Clinical jazz: harmonizing clinical experience and evidence-based medicine. J Fam Pract 1998;47:425-428.
13. Kenny NP. Does good science make good medicine? Incorporating evidence into practice is complicated by the fact that clinical practice is as much art as science. CMAJ 1997;157:33-36.
14. Gillick MR. Medicare coverage for technological innovations—time for new criteria? N Engl J Med 2004;350:2199-2203.
15. Tunis SR. Why Medicare has not established criteria for coverage decisions. N Engl J Med 2004;350:2196-2198.
16. Schwartz LM, Woloshin S, Fowler FJ,, Jr, Welch HG. Enthusiasm for cancer screening in the United States. JAMA 2004;291:71-78.
17. Karnon J, Peters J, Platt J, Chilcott J, McGoogan E, Brewer N. Liquid-based cytology in cervical screening: an updated rapid and systematic review and economic analysis. Health Technol Assess 2004;8:iii, 1-78.
18. Smith M, French L, Barry HC. Periodic abstinence from Pap (PAP) smear study: women’s perceptions of Pap smear screening. Ann Fam Med 2003;1:203-208.
Is osteoporosis screening in postmenopausal women effective?
No single study evaluates the effectiveness of osteoporosis screening. However, screening women over the age of 65 years—or those between 60–64 years with certain risk factors—is recommended based on available evidence.
First, osteoporosis is common, and its prevalence increases with age (strength of recommendation [SOR]: A—prospective cohort studies). Second, low bone mineral density predicts fracture risk (SOR: A—prospective cohort studies). Finally, the likelihood of osteoporotic fracture is reduced with therapy, such as alendronate 10 mg/day or risedronate 5 mg/day plus adequate daily calcium and vitamin D (SOR: A—meta-analysis of randomized clinical trials).
Women under 60 years should not be screened (SOR: B—clinical decision rule). There is no evidence to guide decisions about screening interval or at what age to stop screening. The long-term risks of newer medications used for osteoporosis are unknown.
Evidence summary
Osteoporosis results in significant morbidity and mortality. In a prospective observational study of women over 50 years of age, 39.6% had osteopenia and 7.2% had osteoporosis. Osteoporosis was associated with a fracture rate 4 times that of normal bone mineral density.1 People with vertebral or hip fractures have a reduced relative 5-year survival of 0.81. Excess mortality occurred within the first 6 months following fracture.2
One prospective cohort study identified 14 independent risk factors for hip fracture.3 The best predictors were female gender, age, low weight, and no current estrogen use. For women aged >65 years with no other risks, 12% to 28% have osteoporosis.4 Multiple risk assessment scales have been studied to identify women aged >65 years who are at increased risk; however, none of the scales had good discriminatory performance.5 As a result, it is unclear which factors for women under 65 years should trigger screening.
While multiple technologies exist to measure bone mineral density, dual-energy x-ray absorptiometry (DEXA) has been the most validated test for predicting fractures. A meta-analysis of 11 prospective cohort trials showed that all sites of bone mineral density measurements correlated with fractures (relative risk [RR], 1.5; 95% confi-dence interval [CI], 1.4–1.6.). However, DEXA of the femoral neck predicted hip fracture better than other measures (RR, 2.6; 95% CI, 2.0–3.5).6
Additionally, heel ultrasonography was compa-rable with hip DEXA for predicting hip fractures for women over 65 years (probability of fracture 0.018 vs. 0.023); no studies have compared effec-tiveness for women under 65 years.
Multiple therapeutic interventions for osteo-porosis have been demonstrated to reduce frac-tures. Adequate calcium and vitamin D appear to prevent fractures. Alendronate and rise-dronate are the only prescription medications with evidence showing they prevent hip fractures.
A meta-analysis of 11 randomized controlled trials including 11,808 women found fewer hip fractures in women taking 10 mg/day of alendronate (RR, 0.51; 95% CI, 0.38–0.69; number needed to treat [NNT]=24), and fewer vertebral fractures in women taking 5 mg/day of alendronate (RR, 0.52; 95% CI, 0.43–0.65; NNT=72).7
For these results to apply to screening, study participants must be similar to those identified by general population screening. All trials included healthy women with low bone mineral density who were not using estrogen, which is similar to women identified by general screening. However, 57% of women recruited for the second Fracture Intervention Trial (FIT-II), the largest study, were classified as ineligible. This raises concern about the study’s generalizability.8
The US Preventive Services Task Force did an outcomes estimation of screening effectiveness, combining all of the above data (Table).9 Screening 731 women aged 65 to 69 years would prevent 1 hip fracture if those with indications for treat-ment took it; screening 248 women would prevent 1 vertebral fracture. As the table demonstrates, benefits increase with age. For women under 65 years, benefits are relatively small, unless they have other risk factors for osteoporosis.
TABLE
Hip and vertebral fracture outcomes for osteoporosis screening in 10,000 postmenopausal women 9
| Age (years) | |||
|---|---|---|---|
| Screening outcomes | 55–59 | 65–69 | 75–79 |
| Identified with osteoporosis | 445 | 1200 | 2850 |
| Hip fracture prevented with medication | 2 | 14 | 70 |
| NNS to prevent 1 hip fracture | 4338 | 731 | 143 |
| NNT to prevent 1 hip fracture | 193 | 88 | 41 |
| Vertebral fractures prevented | 7 | 40 | 134 |
| NNS to prevent 1 vertebral fracture | 1338 | 248 | 75 |
| NNT to prevent 1 vertebral fracture | 60 | 30 | 21 |
| The calculations in this table assume that treatment reduces the risk of vertebral fracture by 48%, the risk of hip fracture to 36%, and that 70% of patients will adhere to therapy. Table modified from USPSTF report.9 | |||
| NNS, number needed to screen for benefit; NNT, number needed to treat for benefit | |||
Recommendations from others
Based on their outcomes model, the US Preventive Services Task Force recommends screening for women aged >65 years, and those aged 60 to 65 years who have risk factors.9 In 1998, the National Osteoporosis Foundation, in collaboration with many other professional organ-izations, recommended bone mineral density test-ing for all women aged >65 years and younger postmenopausal women who have had or are at risk for fractures.10 The 2000 Consensus Development Conference from the National Institutes of Health recommended an individual-ized approach to screening, stating evidence for universal osteoporosis screening is inconclusive.11 The American Association of Clinical Endo-crinologists revised guidelines in 2001 to include screening younger postmenopausal women with a body weight <127 lbs or a family history of nontraumatic spine or hip fracture.12
Michael L. Lefevre, MD, MSPH
Department of Family and Community Medicine, University of Missouri–Columbia
The value of screening for osteoporosis is a much bigger issue for clinicians since the pub-lication of the Women’s Health Initiative study and the consequent decline in the number of postmenopausal women using HRT. Evidence for pharmacologic prevention of fractures in women who do not meet conventional criteria for osteoporosis is lacking. Data on fracture risk with osteoporosis are short-term, and the risks and benefits of long-term treatment of women who do have osteoporosis are unknown for all of the treatment options.
The conclusion to focus our screening efforts on women aged 65 years and older, where the near-term benefits seem to clearly outweigh the risks, is certainly clinically prudent. Irrespective of our wishes, many women in their fifties are getting osteoporosis screening at health fairs or shopping malls. Although I do not encourage this age group to be screened, when faced with results showing osteoporosis, I do still treat with a bisphosphonate, based on the trials noted above.
1. Siris ES, Miller PD, Barrett-Connor E, et al. Identification and fracture outcomes of undiagnosed low bone mineral density in postmenopausal women: results from the National Osteoporosis Risk Assessment. JAMA 2001;286:2815-2822.
2. Cooper C, Atkinson EJ, Jacobsen SJ, O’Fallon WM, Melton LJ, 3rd. Population-based study of survival after osteo-porotic fractures. Am J Epidemiol 1993;137:1001-1005.
3. Cummings SR, Nevitt MC, Browner WS, et al. Risk factors for hip fracture in white women. Study of Osteoporotic Fractures Research Group. N Engl J Med 1995;332:767-773.
4. Cadarette SM, Jaglal SB, Kreiger N, McIsaac WJ, Darlington GA, Tu JV. Development and validation of the Osteoporosis Risk Assessment Instrument to facilitate selection of women for bone densitometry. CMAJ 2000;162:1289-1294.
5. Cadarette SM, Jaglal SB, Murray TM, McIsaac WJ, Joseph L, Brown JP. Evaluation of decision rules for referring women for bone densitometry by dual-energy x-ray absorptiometry. JAMA 2001;286:57-63.
6. Marshall D, Johnell O, Wedel H. Meta-analysis of how well measures of bone marrow density predict occurrence of osteoporotic fractures. BMJ 1996;312:1254-1259.
7. Cranney A, Tugwell P, Adachi J, et al. Meta-analyses of therapies for postmenopausal osteoporosis. III. Meta-analysis of risedronate for the treatment of postmenopausal osteoporosis. Endocr Rev 2002;23:517-523.
8. Cummings SR, Black DM, Thompson DE, et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA 1998;280:2077-2082.
9. Nelson HD, Helfand M, Woolf SH, Allan JD. Screening for postmenopausal osteoporosis: a review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med 2002;137:529-541.
10. Physicians Guide to Prevention and Treatment of Osteoporosis. National Osteoporosis Foundation. Wash-ington, DC: National Osteoporosis Foundation; 1999. Available at: www.nof.org/physguide. Accessed on February 24, 2003.
11. Osteoporosis prevention, diagnosis, and therapy. NIH Consensus Statement. 2000; 17:1–45. Available at: http://odp.od.nih.gov/consensus/cons/111/111_state-ment.htm. Accessed on February 24, 2003.
12. American Association of Clinical Endocrinologists. 2001 Medical Guidelines for Clinical Practice for the Prevention and Management of Postmenopausal Osteoporosis. Available at: www.aace.com/clin/guidelines/osteoporosis2001.pdf. Accessed on February 24, 2003.
No single study evaluates the effectiveness of osteoporosis screening. However, screening women over the age of 65 years—or those between 60–64 years with certain risk factors—is recommended based on available evidence.
First, osteoporosis is common, and its prevalence increases with age (strength of recommendation [SOR]: A—prospective cohort studies). Second, low bone mineral density predicts fracture risk (SOR: A—prospective cohort studies). Finally, the likelihood of osteoporotic fracture is reduced with therapy, such as alendronate 10 mg/day or risedronate 5 mg/day plus adequate daily calcium and vitamin D (SOR: A—meta-analysis of randomized clinical trials).
Women under 60 years should not be screened (SOR: B—clinical decision rule). There is no evidence to guide decisions about screening interval or at what age to stop screening. The long-term risks of newer medications used for osteoporosis are unknown.
Evidence summary
Osteoporosis results in significant morbidity and mortality. In a prospective observational study of women over 50 years of age, 39.6% had osteopenia and 7.2% had osteoporosis. Osteoporosis was associated with a fracture rate 4 times that of normal bone mineral density.1 People with vertebral or hip fractures have a reduced relative 5-year survival of 0.81. Excess mortality occurred within the first 6 months following fracture.2
One prospective cohort study identified 14 independent risk factors for hip fracture.3 The best predictors were female gender, age, low weight, and no current estrogen use. For women aged >65 years with no other risks, 12% to 28% have osteoporosis.4 Multiple risk assessment scales have been studied to identify women aged >65 years who are at increased risk; however, none of the scales had good discriminatory performance.5 As a result, it is unclear which factors for women under 65 years should trigger screening.
While multiple technologies exist to measure bone mineral density, dual-energy x-ray absorptiometry (DEXA) has been the most validated test for predicting fractures. A meta-analysis of 11 prospective cohort trials showed that all sites of bone mineral density measurements correlated with fractures (relative risk [RR], 1.5; 95% confi-dence interval [CI], 1.4–1.6.). However, DEXA of the femoral neck predicted hip fracture better than other measures (RR, 2.6; 95% CI, 2.0–3.5).6
Additionally, heel ultrasonography was compa-rable with hip DEXA for predicting hip fractures for women over 65 years (probability of fracture 0.018 vs. 0.023); no studies have compared effec-tiveness for women under 65 years.
Multiple therapeutic interventions for osteo-porosis have been demonstrated to reduce frac-tures. Adequate calcium and vitamin D appear to prevent fractures. Alendronate and rise-dronate are the only prescription medications with evidence showing they prevent hip fractures.
A meta-analysis of 11 randomized controlled trials including 11,808 women found fewer hip fractures in women taking 10 mg/day of alendronate (RR, 0.51; 95% CI, 0.38–0.69; number needed to treat [NNT]=24), and fewer vertebral fractures in women taking 5 mg/day of alendronate (RR, 0.52; 95% CI, 0.43–0.65; NNT=72).7
For these results to apply to screening, study participants must be similar to those identified by general population screening. All trials included healthy women with low bone mineral density who were not using estrogen, which is similar to women identified by general screening. However, 57% of women recruited for the second Fracture Intervention Trial (FIT-II), the largest study, were classified as ineligible. This raises concern about the study’s generalizability.8
The US Preventive Services Task Force did an outcomes estimation of screening effectiveness, combining all of the above data (Table).9 Screening 731 women aged 65 to 69 years would prevent 1 hip fracture if those with indications for treat-ment took it; screening 248 women would prevent 1 vertebral fracture. As the table demonstrates, benefits increase with age. For women under 65 years, benefits are relatively small, unless they have other risk factors for osteoporosis.
TABLE
Hip and vertebral fracture outcomes for osteoporosis screening in 10,000 postmenopausal women 9
| Age (years) | |||
|---|---|---|---|
| Screening outcomes | 55–59 | 65–69 | 75–79 |
| Identified with osteoporosis | 445 | 1200 | 2850 |
| Hip fracture prevented with medication | 2 | 14 | 70 |
| NNS to prevent 1 hip fracture | 4338 | 731 | 143 |
| NNT to prevent 1 hip fracture | 193 | 88 | 41 |
| Vertebral fractures prevented | 7 | 40 | 134 |
| NNS to prevent 1 vertebral fracture | 1338 | 248 | 75 |
| NNT to prevent 1 vertebral fracture | 60 | 30 | 21 |
| The calculations in this table assume that treatment reduces the risk of vertebral fracture by 48%, the risk of hip fracture to 36%, and that 70% of patients will adhere to therapy. Table modified from USPSTF report.9 | |||
| NNS, number needed to screen for benefit; NNT, number needed to treat for benefit | |||
Recommendations from others
Based on their outcomes model, the US Preventive Services Task Force recommends screening for women aged >65 years, and those aged 60 to 65 years who have risk factors.9 In 1998, the National Osteoporosis Foundation, in collaboration with many other professional organ-izations, recommended bone mineral density test-ing for all women aged >65 years and younger postmenopausal women who have had or are at risk for fractures.10 The 2000 Consensus Development Conference from the National Institutes of Health recommended an individual-ized approach to screening, stating evidence for universal osteoporosis screening is inconclusive.11 The American Association of Clinical Endo-crinologists revised guidelines in 2001 to include screening younger postmenopausal women with a body weight <127 lbs or a family history of nontraumatic spine or hip fracture.12
Michael L. Lefevre, MD, MSPH
Department of Family and Community Medicine, University of Missouri–Columbia
The value of screening for osteoporosis is a much bigger issue for clinicians since the pub-lication of the Women’s Health Initiative study and the consequent decline in the number of postmenopausal women using HRT. Evidence for pharmacologic prevention of fractures in women who do not meet conventional criteria for osteoporosis is lacking. Data on fracture risk with osteoporosis are short-term, and the risks and benefits of long-term treatment of women who do have osteoporosis are unknown for all of the treatment options.
The conclusion to focus our screening efforts on women aged 65 years and older, where the near-term benefits seem to clearly outweigh the risks, is certainly clinically prudent. Irrespective of our wishes, many women in their fifties are getting osteoporosis screening at health fairs or shopping malls. Although I do not encourage this age group to be screened, when faced with results showing osteoporosis, I do still treat with a bisphosphonate, based on the trials noted above.
No single study evaluates the effectiveness of osteoporosis screening. However, screening women over the age of 65 years—or those between 60–64 years with certain risk factors—is recommended based on available evidence.
First, osteoporosis is common, and its prevalence increases with age (strength of recommendation [SOR]: A—prospective cohort studies). Second, low bone mineral density predicts fracture risk (SOR: A—prospective cohort studies). Finally, the likelihood of osteoporotic fracture is reduced with therapy, such as alendronate 10 mg/day or risedronate 5 mg/day plus adequate daily calcium and vitamin D (SOR: A—meta-analysis of randomized clinical trials).
Women under 60 years should not be screened (SOR: B—clinical decision rule). There is no evidence to guide decisions about screening interval or at what age to stop screening. The long-term risks of newer medications used for osteoporosis are unknown.
Evidence summary
Osteoporosis results in significant morbidity and mortality. In a prospective observational study of women over 50 years of age, 39.6% had osteopenia and 7.2% had osteoporosis. Osteoporosis was associated with a fracture rate 4 times that of normal bone mineral density.1 People with vertebral or hip fractures have a reduced relative 5-year survival of 0.81. Excess mortality occurred within the first 6 months following fracture.2
One prospective cohort study identified 14 independent risk factors for hip fracture.3 The best predictors were female gender, age, low weight, and no current estrogen use. For women aged >65 years with no other risks, 12% to 28% have osteoporosis.4 Multiple risk assessment scales have been studied to identify women aged >65 years who are at increased risk; however, none of the scales had good discriminatory performance.5 As a result, it is unclear which factors for women under 65 years should trigger screening.
While multiple technologies exist to measure bone mineral density, dual-energy x-ray absorptiometry (DEXA) has been the most validated test for predicting fractures. A meta-analysis of 11 prospective cohort trials showed that all sites of bone mineral density measurements correlated with fractures (relative risk [RR], 1.5; 95% confi-dence interval [CI], 1.4–1.6.). However, DEXA of the femoral neck predicted hip fracture better than other measures (RR, 2.6; 95% CI, 2.0–3.5).6
Additionally, heel ultrasonography was compa-rable with hip DEXA for predicting hip fractures for women over 65 years (probability of fracture 0.018 vs. 0.023); no studies have compared effec-tiveness for women under 65 years.
Multiple therapeutic interventions for osteo-porosis have been demonstrated to reduce frac-tures. Adequate calcium and vitamin D appear to prevent fractures. Alendronate and rise-dronate are the only prescription medications with evidence showing they prevent hip fractures.
A meta-analysis of 11 randomized controlled trials including 11,808 women found fewer hip fractures in women taking 10 mg/day of alendronate (RR, 0.51; 95% CI, 0.38–0.69; number needed to treat [NNT]=24), and fewer vertebral fractures in women taking 5 mg/day of alendronate (RR, 0.52; 95% CI, 0.43–0.65; NNT=72).7
For these results to apply to screening, study participants must be similar to those identified by general population screening. All trials included healthy women with low bone mineral density who were not using estrogen, which is similar to women identified by general screening. However, 57% of women recruited for the second Fracture Intervention Trial (FIT-II), the largest study, were classified as ineligible. This raises concern about the study’s generalizability.8
The US Preventive Services Task Force did an outcomes estimation of screening effectiveness, combining all of the above data (Table).9 Screening 731 women aged 65 to 69 years would prevent 1 hip fracture if those with indications for treat-ment took it; screening 248 women would prevent 1 vertebral fracture. As the table demonstrates, benefits increase with age. For women under 65 years, benefits are relatively small, unless they have other risk factors for osteoporosis.
TABLE
Hip and vertebral fracture outcomes for osteoporosis screening in 10,000 postmenopausal women 9
| Age (years) | |||
|---|---|---|---|
| Screening outcomes | 55–59 | 65–69 | 75–79 |
| Identified with osteoporosis | 445 | 1200 | 2850 |
| Hip fracture prevented with medication | 2 | 14 | 70 |
| NNS to prevent 1 hip fracture | 4338 | 731 | 143 |
| NNT to prevent 1 hip fracture | 193 | 88 | 41 |
| Vertebral fractures prevented | 7 | 40 | 134 |
| NNS to prevent 1 vertebral fracture | 1338 | 248 | 75 |
| NNT to prevent 1 vertebral fracture | 60 | 30 | 21 |
| The calculations in this table assume that treatment reduces the risk of vertebral fracture by 48%, the risk of hip fracture to 36%, and that 70% of patients will adhere to therapy. Table modified from USPSTF report.9 | |||
| NNS, number needed to screen for benefit; NNT, number needed to treat for benefit | |||
Recommendations from others
Based on their outcomes model, the US Preventive Services Task Force recommends screening for women aged >65 years, and those aged 60 to 65 years who have risk factors.9 In 1998, the National Osteoporosis Foundation, in collaboration with many other professional organ-izations, recommended bone mineral density test-ing for all women aged >65 years and younger postmenopausal women who have had or are at risk for fractures.10 The 2000 Consensus Development Conference from the National Institutes of Health recommended an individual-ized approach to screening, stating evidence for universal osteoporosis screening is inconclusive.11 The American Association of Clinical Endo-crinologists revised guidelines in 2001 to include screening younger postmenopausal women with a body weight <127 lbs or a family history of nontraumatic spine or hip fracture.12
Michael L. Lefevre, MD, MSPH
Department of Family and Community Medicine, University of Missouri–Columbia
The value of screening for osteoporosis is a much bigger issue for clinicians since the pub-lication of the Women’s Health Initiative study and the consequent decline in the number of postmenopausal women using HRT. Evidence for pharmacologic prevention of fractures in women who do not meet conventional criteria for osteoporosis is lacking. Data on fracture risk with osteoporosis are short-term, and the risks and benefits of long-term treatment of women who do have osteoporosis are unknown for all of the treatment options.
The conclusion to focus our screening efforts on women aged 65 years and older, where the near-term benefits seem to clearly outweigh the risks, is certainly clinically prudent. Irrespective of our wishes, many women in their fifties are getting osteoporosis screening at health fairs or shopping malls. Although I do not encourage this age group to be screened, when faced with results showing osteoporosis, I do still treat with a bisphosphonate, based on the trials noted above.
1. Siris ES, Miller PD, Barrett-Connor E, et al. Identification and fracture outcomes of undiagnosed low bone mineral density in postmenopausal women: results from the National Osteoporosis Risk Assessment. JAMA 2001;286:2815-2822.
2. Cooper C, Atkinson EJ, Jacobsen SJ, O’Fallon WM, Melton LJ, 3rd. Population-based study of survival after osteo-porotic fractures. Am J Epidemiol 1993;137:1001-1005.
3. Cummings SR, Nevitt MC, Browner WS, et al. Risk factors for hip fracture in white women. Study of Osteoporotic Fractures Research Group. N Engl J Med 1995;332:767-773.
4. Cadarette SM, Jaglal SB, Kreiger N, McIsaac WJ, Darlington GA, Tu JV. Development and validation of the Osteoporosis Risk Assessment Instrument to facilitate selection of women for bone densitometry. CMAJ 2000;162:1289-1294.
5. Cadarette SM, Jaglal SB, Murray TM, McIsaac WJ, Joseph L, Brown JP. Evaluation of decision rules for referring women for bone densitometry by dual-energy x-ray absorptiometry. JAMA 2001;286:57-63.
6. Marshall D, Johnell O, Wedel H. Meta-analysis of how well measures of bone marrow density predict occurrence of osteoporotic fractures. BMJ 1996;312:1254-1259.
7. Cranney A, Tugwell P, Adachi J, et al. Meta-analyses of therapies for postmenopausal osteoporosis. III. Meta-analysis of risedronate for the treatment of postmenopausal osteoporosis. Endocr Rev 2002;23:517-523.
8. Cummings SR, Black DM, Thompson DE, et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA 1998;280:2077-2082.
9. Nelson HD, Helfand M, Woolf SH, Allan JD. Screening for postmenopausal osteoporosis: a review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med 2002;137:529-541.
10. Physicians Guide to Prevention and Treatment of Osteoporosis. National Osteoporosis Foundation. Wash-ington, DC: National Osteoporosis Foundation; 1999. Available at: www.nof.org/physguide. Accessed on February 24, 2003.
11. Osteoporosis prevention, diagnosis, and therapy. NIH Consensus Statement. 2000; 17:1–45. Available at: http://odp.od.nih.gov/consensus/cons/111/111_state-ment.htm. Accessed on February 24, 2003.
12. American Association of Clinical Endocrinologists. 2001 Medical Guidelines for Clinical Practice for the Prevention and Management of Postmenopausal Osteoporosis. Available at: www.aace.com/clin/guidelines/osteoporosis2001.pdf. Accessed on February 24, 2003.
1. Siris ES, Miller PD, Barrett-Connor E, et al. Identification and fracture outcomes of undiagnosed low bone mineral density in postmenopausal women: results from the National Osteoporosis Risk Assessment. JAMA 2001;286:2815-2822.
2. Cooper C, Atkinson EJ, Jacobsen SJ, O’Fallon WM, Melton LJ, 3rd. Population-based study of survival after osteo-porotic fractures. Am J Epidemiol 1993;137:1001-1005.
3. Cummings SR, Nevitt MC, Browner WS, et al. Risk factors for hip fracture in white women. Study of Osteoporotic Fractures Research Group. N Engl J Med 1995;332:767-773.
4. Cadarette SM, Jaglal SB, Kreiger N, McIsaac WJ, Darlington GA, Tu JV. Development and validation of the Osteoporosis Risk Assessment Instrument to facilitate selection of women for bone densitometry. CMAJ 2000;162:1289-1294.
5. Cadarette SM, Jaglal SB, Murray TM, McIsaac WJ, Joseph L, Brown JP. Evaluation of decision rules for referring women for bone densitometry by dual-energy x-ray absorptiometry. JAMA 2001;286:57-63.
6. Marshall D, Johnell O, Wedel H. Meta-analysis of how well measures of bone marrow density predict occurrence of osteoporotic fractures. BMJ 1996;312:1254-1259.
7. Cranney A, Tugwell P, Adachi J, et al. Meta-analyses of therapies for postmenopausal osteoporosis. III. Meta-analysis of risedronate for the treatment of postmenopausal osteoporosis. Endocr Rev 2002;23:517-523.
8. Cummings SR, Black DM, Thompson DE, et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA 1998;280:2077-2082.
9. Nelson HD, Helfand M, Woolf SH, Allan JD. Screening for postmenopausal osteoporosis: a review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med 2002;137:529-541.
10. Physicians Guide to Prevention and Treatment of Osteoporosis. National Osteoporosis Foundation. Wash-ington, DC: National Osteoporosis Foundation; 1999. Available at: www.nof.org/physguide. Accessed on February 24, 2003.
11. Osteoporosis prevention, diagnosis, and therapy. NIH Consensus Statement. 2000; 17:1–45. Available at: http://odp.od.nih.gov/consensus/cons/111/111_state-ment.htm. Accessed on February 24, 2003.
12. American Association of Clinical Endocrinologists. 2001 Medical Guidelines for Clinical Practice for the Prevention and Management of Postmenopausal Osteoporosis. Available at: www.aace.com/clin/guidelines/osteoporosis2001.pdf. Accessed on February 24, 2003.
Evidence-based answers from the Family Physicians Inquiries Network
Does magnesium therapy early in acute MI reduce mortality?
Short-term mortality is not reduced with early administration of intravenous magnesium in high-risk patients having an acute myocardial infarction (MI). There is no reason to give intravenous magnesium unless patients have other indications for repletion, such as a low magnesium level or arrhythmia responsive to magnesium therapy.
Short-term mortality is not reduced with early administration of intravenous magnesium in high-risk patients having an acute myocardial infarction (MI). There is no reason to give intravenous magnesium unless patients have other indications for repletion, such as a low magnesium level or arrhythmia responsive to magnesium therapy.
Short-term mortality is not reduced with early administration of intravenous magnesium in high-risk patients having an acute myocardial infarction (MI). There is no reason to give intravenous magnesium unless patients have other indications for repletion, such as a low magnesium level or arrhythmia responsive to magnesium therapy.
Warfarin plus aspirin more effective than aspirin alone for secondary prevention of MI
Compared with aspirin alone, aspirin plus warfarin (goal for international normalized ratio, 2–2.5) or warfarin alone (goal for international normalized ratio, 2.8–4.3) results in fewer reinfarctions and thromboembolic events.
Treating 1000 patients for 1 year would result in approximately 10 fewer reinfarctions and 3 fewer strokes at a cost of 4 more major bleeding episodes. In addition, many patients will not be able to tolerate warfarin therapy. For highly motivated patients at low risk of bleeding, warfarin or warfarin plus aspirin is more effective than aspirin for secondary prevention of myocardial infarction.
Compared with aspirin alone, aspirin plus warfarin (goal for international normalized ratio, 2–2.5) or warfarin alone (goal for international normalized ratio, 2.8–4.3) results in fewer reinfarctions and thromboembolic events.
Treating 1000 patients for 1 year would result in approximately 10 fewer reinfarctions and 3 fewer strokes at a cost of 4 more major bleeding episodes. In addition, many patients will not be able to tolerate warfarin therapy. For highly motivated patients at low risk of bleeding, warfarin or warfarin plus aspirin is more effective than aspirin for secondary prevention of myocardial infarction.
Compared with aspirin alone, aspirin plus warfarin (goal for international normalized ratio, 2–2.5) or warfarin alone (goal for international normalized ratio, 2.8–4.3) results in fewer reinfarctions and thromboembolic events.
Treating 1000 patients for 1 year would result in approximately 10 fewer reinfarctions and 3 fewer strokes at a cost of 4 more major bleeding episodes. In addition, many patients will not be able to tolerate warfarin therapy. For highly motivated patients at low risk of bleeding, warfarin or warfarin plus aspirin is more effective than aspirin for secondary prevention of myocardial infarction.
Is a 7-day course of ciprofloxacin effective in the treatment of uncomplicated pyelonephritis in women?
BACKGROUND: The current recommendation for management of uncomplicated pyelonephritis is a 14-day course of ciprofloxacin.1 Studies have shown this to be 90% effective.2 Few studies have evaluated shorter courses of therapy for pyelonephritis. The purpose of this study was to compare the effectiveness of 7 days of ciprofloxacin with 14 days of trimethoprim-sulfamethoxazole (TMP-SMZ) for treatment of acute uncomplicated pyelonephritis in an outpatient setting.
POPULATION STUDIED: The study participants were premenopausal women aged 18 years or older with a clinical diagnosis of pyelonephritis, defined as flank pain or costovertebral angle tenderness, fever, and pyuria. Patients were excluded if they had abnormal renal function (creatinine >2.7), severe sepsis, urologic abnormalities, persistent vomiting, or if they were immunocompromised, had diabetes, were admitted to the hospital, or were pregnant or lactating.
STUDY DESIGN AND VALIDITY: A total of 378 patients were randomized to receive either 7 days of ciprofloxacin 500 mg twice daily or 14 days of TMP-SMZ 800/160 mg twice daily. In both groups, managing physicians had the option to treat patients with an initial dose of intravenous antibiotic, if clinically indicated (400 mg of ciprofloxacin in the ciprofloxacin group or 1 gram of ceftriaxone in the TMP-SMZ group). Blood cultures and a urine culture were obtained by either clean catch or catheterization before therapy was initiated. Urine cultures were repeated on days 3 to 5 of treatment. Patients were evaluated at 4 to 11 days and 22 to 48 days following treatment to assess for clinical cure and to repeat urine cultures.
OUTCOMES MEASURED: Primary study outcomes were bacteriologic and clinical cures at a visit 4 to 11 days post-therapy, as determined by urine culture and signs and symptoms, respectively. Secondary outcomes included bacteriologic and clinical responses at the visit 22 to 48 days post-therapy, adverse drug events, and a health resource analysis.
RESULTS: At 4 to 11 days post-therapy, the efficacy analysis showed that patients treated with ciprofloxacin had a better bacteriologic cure rate than the patients treated with TMP-SMZ (99% vs 89%, P=.004; number needed to treat [NNT]=10) and a better clinical cure rate (96% vs 83%, P=.002; NNT=7.6). Escherichia coli represented 90% of cultured organisms, of which 18% were resistant to TMP-SMZ, and <1% were resistant to ciprofloxacin. When the analysis was done using only organisms sensitive to TMP-SMZ, the efficacy rates were similar. An initial IV dose was associated with a greater cure rate in the TMP-SMZ group, but not in the ciprofloxacin group. In the intention-to-treat analysis, clinical cure rates for ciprofloxacin were better than TMP-SMZ at 22 to 48 days post-therapy (82% vs 72%; 95% confidence interval [CI], 0.01-0.19; NNT=10). Benefits were also seen when comparing ciprofloxacin with TMP-SMZ for bacteriologic cure (84% vs 74%; 95% CI, 0.01-0.19; NNT=10). Adverse events occurred in 24% of the ciprofloxacin and 33% of the TMP-SMZ group; 6% of patients taking ciprofloxacin and 11% taking TMP-SMZ discontinued the drug. The cost per cure was $615 for ciprofloxacin compared with $770 for TMP-SMZ; however, this study did not have enough power to detect a statistically significant difference.
The results of this study show 7 days of ciprofloxacin to be superior to 14 days of TMP-SMZ in the outpatient treatment of uncomplicated pyelonephritis. This result is largely because of the existence of organisms resistant to TMP-SMZ. It remains to be seen whether a 7-day treatment with ciprofloxacin should replace the 14-day treatment of the same drug currently recommended.
BACKGROUND: The current recommendation for management of uncomplicated pyelonephritis is a 14-day course of ciprofloxacin.1 Studies have shown this to be 90% effective.2 Few studies have evaluated shorter courses of therapy for pyelonephritis. The purpose of this study was to compare the effectiveness of 7 days of ciprofloxacin with 14 days of trimethoprim-sulfamethoxazole (TMP-SMZ) for treatment of acute uncomplicated pyelonephritis in an outpatient setting.
POPULATION STUDIED: The study participants were premenopausal women aged 18 years or older with a clinical diagnosis of pyelonephritis, defined as flank pain or costovertebral angle tenderness, fever, and pyuria. Patients were excluded if they had abnormal renal function (creatinine >2.7), severe sepsis, urologic abnormalities, persistent vomiting, or if they were immunocompromised, had diabetes, were admitted to the hospital, or were pregnant or lactating.
STUDY DESIGN AND VALIDITY: A total of 378 patients were randomized to receive either 7 days of ciprofloxacin 500 mg twice daily or 14 days of TMP-SMZ 800/160 mg twice daily. In both groups, managing physicians had the option to treat patients with an initial dose of intravenous antibiotic, if clinically indicated (400 mg of ciprofloxacin in the ciprofloxacin group or 1 gram of ceftriaxone in the TMP-SMZ group). Blood cultures and a urine culture were obtained by either clean catch or catheterization before therapy was initiated. Urine cultures were repeated on days 3 to 5 of treatment. Patients were evaluated at 4 to 11 days and 22 to 48 days following treatment to assess for clinical cure and to repeat urine cultures.
OUTCOMES MEASURED: Primary study outcomes were bacteriologic and clinical cures at a visit 4 to 11 days post-therapy, as determined by urine culture and signs and symptoms, respectively. Secondary outcomes included bacteriologic and clinical responses at the visit 22 to 48 days post-therapy, adverse drug events, and a health resource analysis.
RESULTS: At 4 to 11 days post-therapy, the efficacy analysis showed that patients treated with ciprofloxacin had a better bacteriologic cure rate than the patients treated with TMP-SMZ (99% vs 89%, P=.004; number needed to treat [NNT]=10) and a better clinical cure rate (96% vs 83%, P=.002; NNT=7.6). Escherichia coli represented 90% of cultured organisms, of which 18% were resistant to TMP-SMZ, and <1% were resistant to ciprofloxacin. When the analysis was done using only organisms sensitive to TMP-SMZ, the efficacy rates were similar. An initial IV dose was associated with a greater cure rate in the TMP-SMZ group, but not in the ciprofloxacin group. In the intention-to-treat analysis, clinical cure rates for ciprofloxacin were better than TMP-SMZ at 22 to 48 days post-therapy (82% vs 72%; 95% confidence interval [CI], 0.01-0.19; NNT=10). Benefits were also seen when comparing ciprofloxacin with TMP-SMZ for bacteriologic cure (84% vs 74%; 95% CI, 0.01-0.19; NNT=10). Adverse events occurred in 24% of the ciprofloxacin and 33% of the TMP-SMZ group; 6% of patients taking ciprofloxacin and 11% taking TMP-SMZ discontinued the drug. The cost per cure was $615 for ciprofloxacin compared with $770 for TMP-SMZ; however, this study did not have enough power to detect a statistically significant difference.
The results of this study show 7 days of ciprofloxacin to be superior to 14 days of TMP-SMZ in the outpatient treatment of uncomplicated pyelonephritis. This result is largely because of the existence of organisms resistant to TMP-SMZ. It remains to be seen whether a 7-day treatment with ciprofloxacin should replace the 14-day treatment of the same drug currently recommended.
BACKGROUND: The current recommendation for management of uncomplicated pyelonephritis is a 14-day course of ciprofloxacin.1 Studies have shown this to be 90% effective.2 Few studies have evaluated shorter courses of therapy for pyelonephritis. The purpose of this study was to compare the effectiveness of 7 days of ciprofloxacin with 14 days of trimethoprim-sulfamethoxazole (TMP-SMZ) for treatment of acute uncomplicated pyelonephritis in an outpatient setting.
POPULATION STUDIED: The study participants were premenopausal women aged 18 years or older with a clinical diagnosis of pyelonephritis, defined as flank pain or costovertebral angle tenderness, fever, and pyuria. Patients were excluded if they had abnormal renal function (creatinine >2.7), severe sepsis, urologic abnormalities, persistent vomiting, or if they were immunocompromised, had diabetes, were admitted to the hospital, or were pregnant or lactating.
STUDY DESIGN AND VALIDITY: A total of 378 patients were randomized to receive either 7 days of ciprofloxacin 500 mg twice daily or 14 days of TMP-SMZ 800/160 mg twice daily. In both groups, managing physicians had the option to treat patients with an initial dose of intravenous antibiotic, if clinically indicated (400 mg of ciprofloxacin in the ciprofloxacin group or 1 gram of ceftriaxone in the TMP-SMZ group). Blood cultures and a urine culture were obtained by either clean catch or catheterization before therapy was initiated. Urine cultures were repeated on days 3 to 5 of treatment. Patients were evaluated at 4 to 11 days and 22 to 48 days following treatment to assess for clinical cure and to repeat urine cultures.
OUTCOMES MEASURED: Primary study outcomes were bacteriologic and clinical cures at a visit 4 to 11 days post-therapy, as determined by urine culture and signs and symptoms, respectively. Secondary outcomes included bacteriologic and clinical responses at the visit 22 to 48 days post-therapy, adverse drug events, and a health resource analysis.
RESULTS: At 4 to 11 days post-therapy, the efficacy analysis showed that patients treated with ciprofloxacin had a better bacteriologic cure rate than the patients treated with TMP-SMZ (99% vs 89%, P=.004; number needed to treat [NNT]=10) and a better clinical cure rate (96% vs 83%, P=.002; NNT=7.6). Escherichia coli represented 90% of cultured organisms, of which 18% were resistant to TMP-SMZ, and <1% were resistant to ciprofloxacin. When the analysis was done using only organisms sensitive to TMP-SMZ, the efficacy rates were similar. An initial IV dose was associated with a greater cure rate in the TMP-SMZ group, but not in the ciprofloxacin group. In the intention-to-treat analysis, clinical cure rates for ciprofloxacin were better than TMP-SMZ at 22 to 48 days post-therapy (82% vs 72%; 95% confidence interval [CI], 0.01-0.19; NNT=10). Benefits were also seen when comparing ciprofloxacin with TMP-SMZ for bacteriologic cure (84% vs 74%; 95% CI, 0.01-0.19; NNT=10). Adverse events occurred in 24% of the ciprofloxacin and 33% of the TMP-SMZ group; 6% of patients taking ciprofloxacin and 11% taking TMP-SMZ discontinued the drug. The cost per cure was $615 for ciprofloxacin compared with $770 for TMP-SMZ; however, this study did not have enough power to detect a statistically significant difference.
The results of this study show 7 days of ciprofloxacin to be superior to 14 days of TMP-SMZ in the outpatient treatment of uncomplicated pyelonephritis. This result is largely because of the existence of organisms resistant to TMP-SMZ. It remains to be seen whether a 7-day treatment with ciprofloxacin should replace the 14-day treatment of the same drug currently recommended.