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Do Annual Pelvic Exams Benefit Asymptomatic Women Who Receive Regular Pap Smears?
No evidence exists to support a clinical benefit from annual pelvic examinations for asymptomatic women who receive Pap smears every 3 to 5 years. However, the American College of Obstetricians and Gynecologists (ACOG) committee on gynecologic practice recommends annual pelvic exams (strength of recommendation [SOR]: C, expert opinion).
Urine testing alone reliably diagnoses gonorrhea and chlamydia (SOR: A, systematic review of cohort studies).
Pelvic examinations unreliably detect adnexal masses (SOR: B, single cohort study); pelvic exams accompanied by ultrasound fail to affect outcomes in ovarian cancer screening (SOR: B, cohort studies).
Pelvic exams aren’t necessary before prescribing oral contraceptive pills (OCPs) (SOR: C, expert opinion).
Vulvar carcinoma has a low prevalence and is usually symptomatic (SOR: B, ecologic study and a case series).
EVIDENCE SUMMARY
A systematic review and meta-analysis included 29 studies that compared the sensitivity and specificity of nucleic acid amplification tests on specimens collected invasively from the cervix or urethra with noninvasively collected urine specimens.1 Studies included both asymptomatic and symptomatic patients. Reference standards varied and included cervical culture, enzyme immunoassay, direct fluorescent antibody, ligase chain reaction, and positive results on 2 of 3 nucleic acid amplification assays.
The sensitivity and specificity of chlamydia and gonorrhea detection didn’t differ between urine and cervical specimens. The pooled sensitivity and specificity for polymerase chain reaction urine samples were 83.3% (95% confidence interval [CI], 77.7%-88.9%) and 99.5% (CI, 99.3%-99.8%), respectively, and for cervical samples 85.5% (CI, 80.3%-90.6%) and 99.6% (CI, 99.4%-99.8%), respectively.1
Pelvic exams detect adnexal masses, but not reliably
A prospective cohort of 127 women undergoing pelvic surgery had preoperative bimanual exams under anesthesia to detect an adnexal mass.2 The gold standard for detection was findings at surgery. The woman had a high prevalence (20%) of ovarian masses. Indications for surgery included diagnosis, sterilization, and suspected malignancy.
When the preoperative bimanual examination detected a left adnexal mass, the odds of finding one at surgery increased 2.8 times, whereas when the exam was normal the odds decreased by 0.8 (positive predictive value [PPV]=0.64; 95% CI, 0.45-0.83). Conversely, the preoperative examination failed to correctly predict a right adnexal mass regardless of the result; the likelihood ratio for both normal and abnormal right adnexal examinations was 1 (PPV=0.26; 95% CI, 0.12-0.47).
What about pelvic exams with ultrasound?
An investigation of transvaginal ultrasonography (TVUS) from November 1987 to January 1991 screened a cohort of 1300 asymptomatic postmenopausal women for an ovarian tumor.3 To be eligible for the study, subjects had to have been without menses for at least 6 months and have no history of a pelvic tumor. Each woman underwent both a pelvic exam and TVUS.
TVUS found that 33 of the women had abnormal ovarian size and morphology when compared with normal standards. Twenty-seven of the 33, who had abnormalities that persisted longer than 1 month, underwent exploratory laparotomy. Ovarian enlargement also was apparent on clinical examination in 10 patients.
Of the 27 patients who underwent surgery, 2 had primary ovarian carcinomas. Significantly, both women had documented normal pelvic examinations on screening.
Another cohort trial conducted between October 1984 and July 1987 studied 801 women ages 40 to 70 years who were at high risk for ovarian cancer.4 Risk factors included nulliparity; symptoms such as abdominal pain, urinary frequency, or irregular bleeding; a personal history of cancer; and a family history of ovarian, breast, or endometrial cancer.
The women underwent both pelvic examination and abdominal ultrasound scanning. Fifty-one patients had abnormal pelvic examinations but normal sonograms. None of the 51 patients, who were followed to the end of the study, developed evidence of ovarian carcinoma. Abnormal abdominal ultrasound scans in 163 patients resulted in 3 diagnoses of malignancy. The 3 patients had normal pelvic examinations.
A pelvic exam isn’t needed before prescribing hormonal contraception
A 2001 JAMA literature review addressed pelvic exams as a prerequisite for administering hormonal contraceptives.5 Investigators identified consensus statements, policy statements, and reviews on the subject and contacted major health associations such as the World Health Organization for their recommendations.
Despite a lack of evidence, these expert sources concluded that a pelvic exam isn’t necessary to identify conditions in which OCPs are contraindicated (pregnancy, breast cancer, hypertension, and thromboembolic disease). Medical history and blood pressure measurement provide adequate screening.
Vulvar cancer is rare and usually symptomatic
Vulvar disease is uncommon and almost always symptomatic. The United Kingdom national cancer registry found an incidence of 3.7 per 100,000.6 A prospective study of 102 women presenting with squamous cell carcinoma of the vulva showed that 94% reported a history of symptomatic vulvar irritation.7 Eighty-eight percent had had symptoms for longer than 6 months.
RECOMMENDATIONS
Regarding screening for gonorrhea and chlamydia, the United States Preventive Services Task Force (USPSTF) states that newer tests, including nucleic acid amplification tests of urine, have improved sensitivity and comparable specificity when compared with cervical culture.8,9
The USPSTF recommends against screening for ovarian cancer in general, (Grade D recommendation: no net benefit or the harms outweigh the benefits). The Task Force states that the sensitivity of pelvic examination in detecting ovarian cancer is unknown based on several ultrasound studies.10
A 2012 ACOG committee opinion recommends that an annual pelvic examination remain a part of the well-woman visit even though the committee found no evidence in support of an annual exam for asymptomatic, low-risk patients.11 The committee notes that patients and providers should discuss the decision to perform a pelvic exam annually.
1. Cook RL, Hutchison SL, østergarrd L, et al. Systemic review: noninvasive testing for Chlamydia trachomatis and Neisseria gonorrheoeae. Ann Intern Med. 2005;142:914-925.
2. Padilla LA, Radosevich DM, Milad MP. Accuracy of the pelvic examination in detecting adnexal masses. Obset Gynecol. 2000;96:593-598.
3. Van Nagell JR Jr, DePriest PD, Puls LE, et al. Ovarian cancer screening in asymptomatic postmenopausal women by transvaginal sonography. Cancer. 1991;68:458-462.
4. Andolf E, Jørgensen C, Astedt B. Ultrasound examination for detection of ovarian carcinoma in risk groups. Obstet Gyenocol. 1990;75:106-109.
5. Stewart FH, Harper CC, Ellerston CE, et al. Clinical breast and pelvic examination requirements for hormonal contraception: current practice vs evidence. JAMA. 2001;285:2232-2239.
6. CancerResearchUK. Vulval cancer incidence statistics. Cancer Research UK Web site. Available at: http://info.cancerresearchuk.org/cancerstats/types/vulva/incidence/. Accessed October 30, 2013.
7. Jones RW, Joura EA. Analyzing prior clinical events at presentation in 102 women with vulvar carcinoma. Evidence of diagnostic delays. J Reprod Med. 1999;44:766-768.
8. US Preventive Services Task Force. Screening for gonorrhea: recommendation statement. Ann Fam Med. 2005;3:263-267.
9. US Preventive Services Task Force. Screening for chlamydial infection: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2007;147:128-134.
10. US Preventive Services Task Force. Screening for ovarian cancer: recommendation statement. Ann Fam Med. 2004;2:260-262.
11. Committee on Gyencologic Practice. Committee opinion no. 534: well-woman visit. Obstet Gynecol. 2012;120:421-424.
No evidence exists to support a clinical benefit from annual pelvic examinations for asymptomatic women who receive Pap smears every 3 to 5 years. However, the American College of Obstetricians and Gynecologists (ACOG) committee on gynecologic practice recommends annual pelvic exams (strength of recommendation [SOR]: C, expert opinion).
Urine testing alone reliably diagnoses gonorrhea and chlamydia (SOR: A, systematic review of cohort studies).
Pelvic examinations unreliably detect adnexal masses (SOR: B, single cohort study); pelvic exams accompanied by ultrasound fail to affect outcomes in ovarian cancer screening (SOR: B, cohort studies).
Pelvic exams aren’t necessary before prescribing oral contraceptive pills (OCPs) (SOR: C, expert opinion).
Vulvar carcinoma has a low prevalence and is usually symptomatic (SOR: B, ecologic study and a case series).
EVIDENCE SUMMARY
A systematic review and meta-analysis included 29 studies that compared the sensitivity and specificity of nucleic acid amplification tests on specimens collected invasively from the cervix or urethra with noninvasively collected urine specimens.1 Studies included both asymptomatic and symptomatic patients. Reference standards varied and included cervical culture, enzyme immunoassay, direct fluorescent antibody, ligase chain reaction, and positive results on 2 of 3 nucleic acid amplification assays.
The sensitivity and specificity of chlamydia and gonorrhea detection didn’t differ between urine and cervical specimens. The pooled sensitivity and specificity for polymerase chain reaction urine samples were 83.3% (95% confidence interval [CI], 77.7%-88.9%) and 99.5% (CI, 99.3%-99.8%), respectively, and for cervical samples 85.5% (CI, 80.3%-90.6%) and 99.6% (CI, 99.4%-99.8%), respectively.1
Pelvic exams detect adnexal masses, but not reliably
A prospective cohort of 127 women undergoing pelvic surgery had preoperative bimanual exams under anesthesia to detect an adnexal mass.2 The gold standard for detection was findings at surgery. The woman had a high prevalence (20%) of ovarian masses. Indications for surgery included diagnosis, sterilization, and suspected malignancy.
When the preoperative bimanual examination detected a left adnexal mass, the odds of finding one at surgery increased 2.8 times, whereas when the exam was normal the odds decreased by 0.8 (positive predictive value [PPV]=0.64; 95% CI, 0.45-0.83). Conversely, the preoperative examination failed to correctly predict a right adnexal mass regardless of the result; the likelihood ratio for both normal and abnormal right adnexal examinations was 1 (PPV=0.26; 95% CI, 0.12-0.47).
What about pelvic exams with ultrasound?
An investigation of transvaginal ultrasonography (TVUS) from November 1987 to January 1991 screened a cohort of 1300 asymptomatic postmenopausal women for an ovarian tumor.3 To be eligible for the study, subjects had to have been without menses for at least 6 months and have no history of a pelvic tumor. Each woman underwent both a pelvic exam and TVUS.
TVUS found that 33 of the women had abnormal ovarian size and morphology when compared with normal standards. Twenty-seven of the 33, who had abnormalities that persisted longer than 1 month, underwent exploratory laparotomy. Ovarian enlargement also was apparent on clinical examination in 10 patients.
Of the 27 patients who underwent surgery, 2 had primary ovarian carcinomas. Significantly, both women had documented normal pelvic examinations on screening.
Another cohort trial conducted between October 1984 and July 1987 studied 801 women ages 40 to 70 years who were at high risk for ovarian cancer.4 Risk factors included nulliparity; symptoms such as abdominal pain, urinary frequency, or irregular bleeding; a personal history of cancer; and a family history of ovarian, breast, or endometrial cancer.
The women underwent both pelvic examination and abdominal ultrasound scanning. Fifty-one patients had abnormal pelvic examinations but normal sonograms. None of the 51 patients, who were followed to the end of the study, developed evidence of ovarian carcinoma. Abnormal abdominal ultrasound scans in 163 patients resulted in 3 diagnoses of malignancy. The 3 patients had normal pelvic examinations.
A pelvic exam isn’t needed before prescribing hormonal contraception
A 2001 JAMA literature review addressed pelvic exams as a prerequisite for administering hormonal contraceptives.5 Investigators identified consensus statements, policy statements, and reviews on the subject and contacted major health associations such as the World Health Organization for their recommendations.
Despite a lack of evidence, these expert sources concluded that a pelvic exam isn’t necessary to identify conditions in which OCPs are contraindicated (pregnancy, breast cancer, hypertension, and thromboembolic disease). Medical history and blood pressure measurement provide adequate screening.
Vulvar cancer is rare and usually symptomatic
Vulvar disease is uncommon and almost always symptomatic. The United Kingdom national cancer registry found an incidence of 3.7 per 100,000.6 A prospective study of 102 women presenting with squamous cell carcinoma of the vulva showed that 94% reported a history of symptomatic vulvar irritation.7 Eighty-eight percent had had symptoms for longer than 6 months.
RECOMMENDATIONS
Regarding screening for gonorrhea and chlamydia, the United States Preventive Services Task Force (USPSTF) states that newer tests, including nucleic acid amplification tests of urine, have improved sensitivity and comparable specificity when compared with cervical culture.8,9
The USPSTF recommends against screening for ovarian cancer in general, (Grade D recommendation: no net benefit or the harms outweigh the benefits). The Task Force states that the sensitivity of pelvic examination in detecting ovarian cancer is unknown based on several ultrasound studies.10
A 2012 ACOG committee opinion recommends that an annual pelvic examination remain a part of the well-woman visit even though the committee found no evidence in support of an annual exam for asymptomatic, low-risk patients.11 The committee notes that patients and providers should discuss the decision to perform a pelvic exam annually.
No evidence exists to support a clinical benefit from annual pelvic examinations for asymptomatic women who receive Pap smears every 3 to 5 years. However, the American College of Obstetricians and Gynecologists (ACOG) committee on gynecologic practice recommends annual pelvic exams (strength of recommendation [SOR]: C, expert opinion).
Urine testing alone reliably diagnoses gonorrhea and chlamydia (SOR: A, systematic review of cohort studies).
Pelvic examinations unreliably detect adnexal masses (SOR: B, single cohort study); pelvic exams accompanied by ultrasound fail to affect outcomes in ovarian cancer screening (SOR: B, cohort studies).
Pelvic exams aren’t necessary before prescribing oral contraceptive pills (OCPs) (SOR: C, expert opinion).
Vulvar carcinoma has a low prevalence and is usually symptomatic (SOR: B, ecologic study and a case series).
EVIDENCE SUMMARY
A systematic review and meta-analysis included 29 studies that compared the sensitivity and specificity of nucleic acid amplification tests on specimens collected invasively from the cervix or urethra with noninvasively collected urine specimens.1 Studies included both asymptomatic and symptomatic patients. Reference standards varied and included cervical culture, enzyme immunoassay, direct fluorescent antibody, ligase chain reaction, and positive results on 2 of 3 nucleic acid amplification assays.
The sensitivity and specificity of chlamydia and gonorrhea detection didn’t differ between urine and cervical specimens. The pooled sensitivity and specificity for polymerase chain reaction urine samples were 83.3% (95% confidence interval [CI], 77.7%-88.9%) and 99.5% (CI, 99.3%-99.8%), respectively, and for cervical samples 85.5% (CI, 80.3%-90.6%) and 99.6% (CI, 99.4%-99.8%), respectively.1
Pelvic exams detect adnexal masses, but not reliably
A prospective cohort of 127 women undergoing pelvic surgery had preoperative bimanual exams under anesthesia to detect an adnexal mass.2 The gold standard for detection was findings at surgery. The woman had a high prevalence (20%) of ovarian masses. Indications for surgery included diagnosis, sterilization, and suspected malignancy.
When the preoperative bimanual examination detected a left adnexal mass, the odds of finding one at surgery increased 2.8 times, whereas when the exam was normal the odds decreased by 0.8 (positive predictive value [PPV]=0.64; 95% CI, 0.45-0.83). Conversely, the preoperative examination failed to correctly predict a right adnexal mass regardless of the result; the likelihood ratio for both normal and abnormal right adnexal examinations was 1 (PPV=0.26; 95% CI, 0.12-0.47).
What about pelvic exams with ultrasound?
An investigation of transvaginal ultrasonography (TVUS) from November 1987 to January 1991 screened a cohort of 1300 asymptomatic postmenopausal women for an ovarian tumor.3 To be eligible for the study, subjects had to have been without menses for at least 6 months and have no history of a pelvic tumor. Each woman underwent both a pelvic exam and TVUS.
TVUS found that 33 of the women had abnormal ovarian size and morphology when compared with normal standards. Twenty-seven of the 33, who had abnormalities that persisted longer than 1 month, underwent exploratory laparotomy. Ovarian enlargement also was apparent on clinical examination in 10 patients.
Of the 27 patients who underwent surgery, 2 had primary ovarian carcinomas. Significantly, both women had documented normal pelvic examinations on screening.
Another cohort trial conducted between October 1984 and July 1987 studied 801 women ages 40 to 70 years who were at high risk for ovarian cancer.4 Risk factors included nulliparity; symptoms such as abdominal pain, urinary frequency, or irregular bleeding; a personal history of cancer; and a family history of ovarian, breast, or endometrial cancer.
The women underwent both pelvic examination and abdominal ultrasound scanning. Fifty-one patients had abnormal pelvic examinations but normal sonograms. None of the 51 patients, who were followed to the end of the study, developed evidence of ovarian carcinoma. Abnormal abdominal ultrasound scans in 163 patients resulted in 3 diagnoses of malignancy. The 3 patients had normal pelvic examinations.
A pelvic exam isn’t needed before prescribing hormonal contraception
A 2001 JAMA literature review addressed pelvic exams as a prerequisite for administering hormonal contraceptives.5 Investigators identified consensus statements, policy statements, and reviews on the subject and contacted major health associations such as the World Health Organization for their recommendations.
Despite a lack of evidence, these expert sources concluded that a pelvic exam isn’t necessary to identify conditions in which OCPs are contraindicated (pregnancy, breast cancer, hypertension, and thromboembolic disease). Medical history and blood pressure measurement provide adequate screening.
Vulvar cancer is rare and usually symptomatic
Vulvar disease is uncommon and almost always symptomatic. The United Kingdom national cancer registry found an incidence of 3.7 per 100,000.6 A prospective study of 102 women presenting with squamous cell carcinoma of the vulva showed that 94% reported a history of symptomatic vulvar irritation.7 Eighty-eight percent had had symptoms for longer than 6 months.
RECOMMENDATIONS
Regarding screening for gonorrhea and chlamydia, the United States Preventive Services Task Force (USPSTF) states that newer tests, including nucleic acid amplification tests of urine, have improved sensitivity and comparable specificity when compared with cervical culture.8,9
The USPSTF recommends against screening for ovarian cancer in general, (Grade D recommendation: no net benefit or the harms outweigh the benefits). The Task Force states that the sensitivity of pelvic examination in detecting ovarian cancer is unknown based on several ultrasound studies.10
A 2012 ACOG committee opinion recommends that an annual pelvic examination remain a part of the well-woman visit even though the committee found no evidence in support of an annual exam for asymptomatic, low-risk patients.11 The committee notes that patients and providers should discuss the decision to perform a pelvic exam annually.
1. Cook RL, Hutchison SL, østergarrd L, et al. Systemic review: noninvasive testing for Chlamydia trachomatis and Neisseria gonorrheoeae. Ann Intern Med. 2005;142:914-925.
2. Padilla LA, Radosevich DM, Milad MP. Accuracy of the pelvic examination in detecting adnexal masses. Obset Gynecol. 2000;96:593-598.
3. Van Nagell JR Jr, DePriest PD, Puls LE, et al. Ovarian cancer screening in asymptomatic postmenopausal women by transvaginal sonography. Cancer. 1991;68:458-462.
4. Andolf E, Jørgensen C, Astedt B. Ultrasound examination for detection of ovarian carcinoma in risk groups. Obstet Gyenocol. 1990;75:106-109.
5. Stewart FH, Harper CC, Ellerston CE, et al. Clinical breast and pelvic examination requirements for hormonal contraception: current practice vs evidence. JAMA. 2001;285:2232-2239.
6. CancerResearchUK. Vulval cancer incidence statistics. Cancer Research UK Web site. Available at: http://info.cancerresearchuk.org/cancerstats/types/vulva/incidence/. Accessed October 30, 2013.
7. Jones RW, Joura EA. Analyzing prior clinical events at presentation in 102 women with vulvar carcinoma. Evidence of diagnostic delays. J Reprod Med. 1999;44:766-768.
8. US Preventive Services Task Force. Screening for gonorrhea: recommendation statement. Ann Fam Med. 2005;3:263-267.
9. US Preventive Services Task Force. Screening for chlamydial infection: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2007;147:128-134.
10. US Preventive Services Task Force. Screening for ovarian cancer: recommendation statement. Ann Fam Med. 2004;2:260-262.
11. Committee on Gyencologic Practice. Committee opinion no. 534: well-woman visit. Obstet Gynecol. 2012;120:421-424.
1. Cook RL, Hutchison SL, østergarrd L, et al. Systemic review: noninvasive testing for Chlamydia trachomatis and Neisseria gonorrheoeae. Ann Intern Med. 2005;142:914-925.
2. Padilla LA, Radosevich DM, Milad MP. Accuracy of the pelvic examination in detecting adnexal masses. Obset Gynecol. 2000;96:593-598.
3. Van Nagell JR Jr, DePriest PD, Puls LE, et al. Ovarian cancer screening in asymptomatic postmenopausal women by transvaginal sonography. Cancer. 1991;68:458-462.
4. Andolf E, Jørgensen C, Astedt B. Ultrasound examination for detection of ovarian carcinoma in risk groups. Obstet Gyenocol. 1990;75:106-109.
5. Stewart FH, Harper CC, Ellerston CE, et al. Clinical breast and pelvic examination requirements for hormonal contraception: current practice vs evidence. JAMA. 2001;285:2232-2239.
6. CancerResearchUK. Vulval cancer incidence statistics. Cancer Research UK Web site. Available at: http://info.cancerresearchuk.org/cancerstats/types/vulva/incidence/. Accessed October 30, 2013.
7. Jones RW, Joura EA. Analyzing prior clinical events at presentation in 102 women with vulvar carcinoma. Evidence of diagnostic delays. J Reprod Med. 1999;44:766-768.
8. US Preventive Services Task Force. Screening for gonorrhea: recommendation statement. Ann Fam Med. 2005;3:263-267.
9. US Preventive Services Task Force. Screening for chlamydial infection: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2007;147:128-134.
10. US Preventive Services Task Force. Screening for ovarian cancer: recommendation statement. Ann Fam Med. 2004;2:260-262.
11. Committee on Gyencologic Practice. Committee opinion no. 534: well-woman visit. Obstet Gynecol. 2012;120:421-424.
Do annual pelvic exams benefit asymptomatic women who receive regular Pap smears?
No evidence exists to support a clinical benefit from annual pelvic examinations for asymptomatic women who receive Pap smears every 3 to 5 years. However, the American College of Obstetricians and Gynecologists (ACOG) committee on gynecologic practice recommends annual pelvic exams (strength of recommendation [SOR]: C, expert opinion).
Urine testing alone reliably diagnoses gonorrhea and chlamydia (SOR: A, systematic review of cohort studies).
Pelvic examinations unreliably detect adnexal masses (SOR: B, single cohort study); pelvic exams accompanied by ultrasound fail to affect outcomes in ovarian cancer screening (SOR: B, cohort studies).
Pelvic exams aren’t necessary before prescribing oral contraceptive pills (OCPs) (SOR: C, expert opinion).
Vulvar carcinoma has a low prevalence and is usually symptomatic (SOR: B, ecologic study and a case series).
EVIDENCE SUMMARY
A systematic review and meta-analysis included 29 studies that compared the sensitivity and specificity of nucleic acid amplification tests on specimens collected invasively from the cervix or urethra with noninvasively collected urine specimens.1 Studies included both asymptomatic and symptomatic patients. Reference standards varied and included cervical culture, enzyme immunoassay, direct fluorescent antibody, ligase chain reaction, and positive results on 2 of 3 nucleic acid amplification assays.
The sensitivity and specificity of chlamydia and gonorrhea detection didn’t differ between urine and cervical specimens. The pooled sensitivity and specificity for polymerase chain reaction urine samples were 83.3% (95% confidence interval [CI], 77.7%-88.9%) and 99.5% (CI, 99.3%-99.8%), respectively, and for cervical samples 85.5% (CI, 80.3%-90.6%) and 99.6% (CI, 99.4%-99.8%), respectively.1
Pelvic exams detect adnexal masses, but not reliably
A prospective cohort of 127 women undergoing pelvic surgery had preoperative bimanual exams under anesthesia to detect an adnexal mass.2 The gold standard for detection was findings at surgery. The woman had a high prevalence (20%) of ovarian masses. Indications for surgery included diagnosis, sterilization, and suspected malignancy.
When the preoperative bimanual examination detected a left adnexal mass, the odds of finding one at surgery increased 2.8 times, whereas when the exam was normal the odds decreased by 0.8 (positive predictive value [PPV]=0.64; 95% CI, 0.45-0.83). Conversely, the preoperative examination failed to correctly predict a right adnexal mass regardless of the result; the likelihood ratio for both normal and abnormal right adnexal examinations was 1 (PPV=0.26; 95% CI, 0.12-0.47).
What about pelvic exams with ultrasound?
An investigation of transvaginal ultrasonography (TVUS) from November 1987 to January 1991 screened a cohort of 1300 asymptomatic postmenopausal women for an ovarian tumor.3 To be eligible for the study, subjects had to have been without menses for at least 6 months and have no history of a pelvic tumor. Each woman underwent both a pelvic exam and TVUS.
TVUS found that 33 of the women had abnormal ovarian size and morphology when compared with normal standards. Twenty-seven of the 33, who had abnormalities that persisted longer than 1 month, underwent exploratory laparotomy. Ovarian enlargement also was apparent on clinical examination in 10 patients.
Of the 27 patients who underwent surgery, 2 had primary ovarian carcinomas. Significantly, both women had documented normal pelvic examinations on screening.
Another cohort trial conducted between October 1984 and July 1987 studied 801 women ages 40 to 70 years who were at high risk for ovarian cancer.4 Risk factors included nulliparity; symptoms such as abdominal pain, urinary frequency, or irregular bleeding; a personal history of cancer; and a family history of ovarian, breast, or endometrial cancer.
The women underwent both pelvic examination and abdominal ultrasound scanning. Fifty-one patients had abnormal pelvic examinations but normal sonograms. None of the 51 patients, who were followed to the end of the study, developed evidence of ovarian carcinoma. Abnormal abdominal ultrasound scans in 163 patients resulted in 3 diagnoses of malignancy. The 3 patients had normal pelvic examinations.
A pelvic exam isn’t needed before prescribing hormonal contraception
A 2001 JAMA literature review addressed pelvic exams as a prerequisite for administering hormonal contraceptives.5 Investigators identified consensus statements, policy statements, and reviews on the subject and contacted major health associations such as the World Health Organization for their recommendations.
Despite a lack of evidence, these expert sources concluded that a pelvic exam isn’t necessary to identify conditions in which OCPs are contraindicated (pregnancy, breast cancer, hypertension, and thromboembolic disease). Medical history and blood pressure measurement provide adequate screening.
Vulvar cancer is rare and usually symptomatic
Vulvar disease is uncommon and almost always symptomatic. The United Kingdom national cancer registry found an incidence of 3.7 per 100,000.6 A prospective study of 102 women presenting with squamous cell carcinoma of the vulva showed that 94% reported a history of symptomatic vulvar irritation.7 Eighty-eight percent had had symptoms for longer than 6 months.
RECOMMENDATIONS
Regarding screening for gonorrhea and chlamydia, the United States Preventive Services Task Force (USPSTF) states that newer tests, including nucleic acid amplification tests of urine, have improved sensitivity and comparable specificity when compared with cervical culture.8,9
The USPSTF recommends against screening for ovarian cancer in general, (Grade D recommendation: no net benefit or the harms outweigh the benefits). The Task Force states that the sensitivity of pelvic examination in detecting ovarian cancer is unknown based on several ultrasound studies.10
A 2012 ACOG committee opinion recommends that an annual pelvic examination remain a part of the well-woman visit even though the committee found no evidence in support of an annual exam for asymptomatic, low-risk patients.11 The committee notes that patients and providers should discuss the decision to perform a pelvic exam annually.
1. Cook RL, Hutchison SL, østergarrd L, et al. Systemic review: noninvasive testing for Chlamydia trachomatis and Neisseria gonorrheoeae. Ann Intern Med. 2005;142:914-925.
2. Padilla LA, Radosevich DM, Milad MP. Accuracy of the pelvic examination in detecting adnexal masses. Obset Gynecol. 2000;96:593-598.
3. Van Nagell JR Jr, DePriest PD, Puls LE, et al. Ovarian cancer screening in asymptomatic postmenopausal women by transvaginal sonography. Cancer. 1991;68:458-462.
4. Andolf E, Jørgensen C, Astedt B. Ultrasound examination for detection of ovarian carcinoma in risk groups. Obstet Gyenocol. 1990;75:106-109.
5. Stewart FH, Harper CC, Ellerston CE, et al. Clinical breast and pelvic examination requirements for hormonal contraception: current practice vs evidence. JAMA. 2001;285:2232-2239.
6. CancerResearchUK. Vulval cancer incidence statistics. Cancer Research UK Web site. Available at: http://info.cancerresearchuk.org/cancerstats/types/vulva/incidence/. Accessed October 30, 2013.
7. Jones RW, Joura EA. Analyzing prior clinical events at presentation in 102 women with vulvar carcinoma. Evidence of diagnostic delays. J Reprod Med. 1999;44:766-768.
8. US Preventive Services Task Force. Screening for gonorrhea: recommendation statement. Ann Fam Med. 2005;3:263-267.
9. US Preventive Services Task Force. Screening for chlamydial infection: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2007;147:128-134.
10. US Preventive Services Task Force. Screening for ovarian cancer: recommendation statement. Ann Fam Med. 2004;2:260-262.
11. Committee on Gyencologic Practice. Committee opinion no. 534: well-woman visit. Obstet Gynecol. 2012;120:421-424.
No evidence exists to support a clinical benefit from annual pelvic examinations for asymptomatic women who receive Pap smears every 3 to 5 years. However, the American College of Obstetricians and Gynecologists (ACOG) committee on gynecologic practice recommends annual pelvic exams (strength of recommendation [SOR]: C, expert opinion).
Urine testing alone reliably diagnoses gonorrhea and chlamydia (SOR: A, systematic review of cohort studies).
Pelvic examinations unreliably detect adnexal masses (SOR: B, single cohort study); pelvic exams accompanied by ultrasound fail to affect outcomes in ovarian cancer screening (SOR: B, cohort studies).
Pelvic exams aren’t necessary before prescribing oral contraceptive pills (OCPs) (SOR: C, expert opinion).
Vulvar carcinoma has a low prevalence and is usually symptomatic (SOR: B, ecologic study and a case series).
EVIDENCE SUMMARY
A systematic review and meta-analysis included 29 studies that compared the sensitivity and specificity of nucleic acid amplification tests on specimens collected invasively from the cervix or urethra with noninvasively collected urine specimens.1 Studies included both asymptomatic and symptomatic patients. Reference standards varied and included cervical culture, enzyme immunoassay, direct fluorescent antibody, ligase chain reaction, and positive results on 2 of 3 nucleic acid amplification assays.
The sensitivity and specificity of chlamydia and gonorrhea detection didn’t differ between urine and cervical specimens. The pooled sensitivity and specificity for polymerase chain reaction urine samples were 83.3% (95% confidence interval [CI], 77.7%-88.9%) and 99.5% (CI, 99.3%-99.8%), respectively, and for cervical samples 85.5% (CI, 80.3%-90.6%) and 99.6% (CI, 99.4%-99.8%), respectively.1
Pelvic exams detect adnexal masses, but not reliably
A prospective cohort of 127 women undergoing pelvic surgery had preoperative bimanual exams under anesthesia to detect an adnexal mass.2 The gold standard for detection was findings at surgery. The woman had a high prevalence (20%) of ovarian masses. Indications for surgery included diagnosis, sterilization, and suspected malignancy.
When the preoperative bimanual examination detected a left adnexal mass, the odds of finding one at surgery increased 2.8 times, whereas when the exam was normal the odds decreased by 0.8 (positive predictive value [PPV]=0.64; 95% CI, 0.45-0.83). Conversely, the preoperative examination failed to correctly predict a right adnexal mass regardless of the result; the likelihood ratio for both normal and abnormal right adnexal examinations was 1 (PPV=0.26; 95% CI, 0.12-0.47).
What about pelvic exams with ultrasound?
An investigation of transvaginal ultrasonography (TVUS) from November 1987 to January 1991 screened a cohort of 1300 asymptomatic postmenopausal women for an ovarian tumor.3 To be eligible for the study, subjects had to have been without menses for at least 6 months and have no history of a pelvic tumor. Each woman underwent both a pelvic exam and TVUS.
TVUS found that 33 of the women had abnormal ovarian size and morphology when compared with normal standards. Twenty-seven of the 33, who had abnormalities that persisted longer than 1 month, underwent exploratory laparotomy. Ovarian enlargement also was apparent on clinical examination in 10 patients.
Of the 27 patients who underwent surgery, 2 had primary ovarian carcinomas. Significantly, both women had documented normal pelvic examinations on screening.
Another cohort trial conducted between October 1984 and July 1987 studied 801 women ages 40 to 70 years who were at high risk for ovarian cancer.4 Risk factors included nulliparity; symptoms such as abdominal pain, urinary frequency, or irregular bleeding; a personal history of cancer; and a family history of ovarian, breast, or endometrial cancer.
The women underwent both pelvic examination and abdominal ultrasound scanning. Fifty-one patients had abnormal pelvic examinations but normal sonograms. None of the 51 patients, who were followed to the end of the study, developed evidence of ovarian carcinoma. Abnormal abdominal ultrasound scans in 163 patients resulted in 3 diagnoses of malignancy. The 3 patients had normal pelvic examinations.
A pelvic exam isn’t needed before prescribing hormonal contraception
A 2001 JAMA literature review addressed pelvic exams as a prerequisite for administering hormonal contraceptives.5 Investigators identified consensus statements, policy statements, and reviews on the subject and contacted major health associations such as the World Health Organization for their recommendations.
Despite a lack of evidence, these expert sources concluded that a pelvic exam isn’t necessary to identify conditions in which OCPs are contraindicated (pregnancy, breast cancer, hypertension, and thromboembolic disease). Medical history and blood pressure measurement provide adequate screening.
Vulvar cancer is rare and usually symptomatic
Vulvar disease is uncommon and almost always symptomatic. The United Kingdom national cancer registry found an incidence of 3.7 per 100,000.6 A prospective study of 102 women presenting with squamous cell carcinoma of the vulva showed that 94% reported a history of symptomatic vulvar irritation.7 Eighty-eight percent had had symptoms for longer than 6 months.
RECOMMENDATIONS
Regarding screening for gonorrhea and chlamydia, the United States Preventive Services Task Force (USPSTF) states that newer tests, including nucleic acid amplification tests of urine, have improved sensitivity and comparable specificity when compared with cervical culture.8,9
The USPSTF recommends against screening for ovarian cancer in general, (Grade D recommendation: no net benefit or the harms outweigh the benefits). The Task Force states that the sensitivity of pelvic examination in detecting ovarian cancer is unknown based on several ultrasound studies.10
A 2012 ACOG committee opinion recommends that an annual pelvic examination remain a part of the well-woman visit even though the committee found no evidence in support of an annual exam for asymptomatic, low-risk patients.11 The committee notes that patients and providers should discuss the decision to perform a pelvic exam annually.
No evidence exists to support a clinical benefit from annual pelvic examinations for asymptomatic women who receive Pap smears every 3 to 5 years. However, the American College of Obstetricians and Gynecologists (ACOG) committee on gynecologic practice recommends annual pelvic exams (strength of recommendation [SOR]: C, expert opinion).
Urine testing alone reliably diagnoses gonorrhea and chlamydia (SOR: A, systematic review of cohort studies).
Pelvic examinations unreliably detect adnexal masses (SOR: B, single cohort study); pelvic exams accompanied by ultrasound fail to affect outcomes in ovarian cancer screening (SOR: B, cohort studies).
Pelvic exams aren’t necessary before prescribing oral contraceptive pills (OCPs) (SOR: C, expert opinion).
Vulvar carcinoma has a low prevalence and is usually symptomatic (SOR: B, ecologic study and a case series).
EVIDENCE SUMMARY
A systematic review and meta-analysis included 29 studies that compared the sensitivity and specificity of nucleic acid amplification tests on specimens collected invasively from the cervix or urethra with noninvasively collected urine specimens.1 Studies included both asymptomatic and symptomatic patients. Reference standards varied and included cervical culture, enzyme immunoassay, direct fluorescent antibody, ligase chain reaction, and positive results on 2 of 3 nucleic acid amplification assays.
The sensitivity and specificity of chlamydia and gonorrhea detection didn’t differ between urine and cervical specimens. The pooled sensitivity and specificity for polymerase chain reaction urine samples were 83.3% (95% confidence interval [CI], 77.7%-88.9%) and 99.5% (CI, 99.3%-99.8%), respectively, and for cervical samples 85.5% (CI, 80.3%-90.6%) and 99.6% (CI, 99.4%-99.8%), respectively.1
Pelvic exams detect adnexal masses, but not reliably
A prospective cohort of 127 women undergoing pelvic surgery had preoperative bimanual exams under anesthesia to detect an adnexal mass.2 The gold standard for detection was findings at surgery. The woman had a high prevalence (20%) of ovarian masses. Indications for surgery included diagnosis, sterilization, and suspected malignancy.
When the preoperative bimanual examination detected a left adnexal mass, the odds of finding one at surgery increased 2.8 times, whereas when the exam was normal the odds decreased by 0.8 (positive predictive value [PPV]=0.64; 95% CI, 0.45-0.83). Conversely, the preoperative examination failed to correctly predict a right adnexal mass regardless of the result; the likelihood ratio for both normal and abnormal right adnexal examinations was 1 (PPV=0.26; 95% CI, 0.12-0.47).
What about pelvic exams with ultrasound?
An investigation of transvaginal ultrasonography (TVUS) from November 1987 to January 1991 screened a cohort of 1300 asymptomatic postmenopausal women for an ovarian tumor.3 To be eligible for the study, subjects had to have been without menses for at least 6 months and have no history of a pelvic tumor. Each woman underwent both a pelvic exam and TVUS.
TVUS found that 33 of the women had abnormal ovarian size and morphology when compared with normal standards. Twenty-seven of the 33, who had abnormalities that persisted longer than 1 month, underwent exploratory laparotomy. Ovarian enlargement also was apparent on clinical examination in 10 patients.
Of the 27 patients who underwent surgery, 2 had primary ovarian carcinomas. Significantly, both women had documented normal pelvic examinations on screening.
Another cohort trial conducted between October 1984 and July 1987 studied 801 women ages 40 to 70 years who were at high risk for ovarian cancer.4 Risk factors included nulliparity; symptoms such as abdominal pain, urinary frequency, or irregular bleeding; a personal history of cancer; and a family history of ovarian, breast, or endometrial cancer.
The women underwent both pelvic examination and abdominal ultrasound scanning. Fifty-one patients had abnormal pelvic examinations but normal sonograms. None of the 51 patients, who were followed to the end of the study, developed evidence of ovarian carcinoma. Abnormal abdominal ultrasound scans in 163 patients resulted in 3 diagnoses of malignancy. The 3 patients had normal pelvic examinations.
A pelvic exam isn’t needed before prescribing hormonal contraception
A 2001 JAMA literature review addressed pelvic exams as a prerequisite for administering hormonal contraceptives.5 Investigators identified consensus statements, policy statements, and reviews on the subject and contacted major health associations such as the World Health Organization for their recommendations.
Despite a lack of evidence, these expert sources concluded that a pelvic exam isn’t necessary to identify conditions in which OCPs are contraindicated (pregnancy, breast cancer, hypertension, and thromboembolic disease). Medical history and blood pressure measurement provide adequate screening.
Vulvar cancer is rare and usually symptomatic
Vulvar disease is uncommon and almost always symptomatic. The United Kingdom national cancer registry found an incidence of 3.7 per 100,000.6 A prospective study of 102 women presenting with squamous cell carcinoma of the vulva showed that 94% reported a history of symptomatic vulvar irritation.7 Eighty-eight percent had had symptoms for longer than 6 months.
RECOMMENDATIONS
Regarding screening for gonorrhea and chlamydia, the United States Preventive Services Task Force (USPSTF) states that newer tests, including nucleic acid amplification tests of urine, have improved sensitivity and comparable specificity when compared with cervical culture.8,9
The USPSTF recommends against screening for ovarian cancer in general, (Grade D recommendation: no net benefit or the harms outweigh the benefits). The Task Force states that the sensitivity of pelvic examination in detecting ovarian cancer is unknown based on several ultrasound studies.10
A 2012 ACOG committee opinion recommends that an annual pelvic examination remain a part of the well-woman visit even though the committee found no evidence in support of an annual exam for asymptomatic, low-risk patients.11 The committee notes that patients and providers should discuss the decision to perform a pelvic exam annually.
1. Cook RL, Hutchison SL, østergarrd L, et al. Systemic review: noninvasive testing for Chlamydia trachomatis and Neisseria gonorrheoeae. Ann Intern Med. 2005;142:914-925.
2. Padilla LA, Radosevich DM, Milad MP. Accuracy of the pelvic examination in detecting adnexal masses. Obset Gynecol. 2000;96:593-598.
3. Van Nagell JR Jr, DePriest PD, Puls LE, et al. Ovarian cancer screening in asymptomatic postmenopausal women by transvaginal sonography. Cancer. 1991;68:458-462.
4. Andolf E, Jørgensen C, Astedt B. Ultrasound examination for detection of ovarian carcinoma in risk groups. Obstet Gyenocol. 1990;75:106-109.
5. Stewart FH, Harper CC, Ellerston CE, et al. Clinical breast and pelvic examination requirements for hormonal contraception: current practice vs evidence. JAMA. 2001;285:2232-2239.
6. CancerResearchUK. Vulval cancer incidence statistics. Cancer Research UK Web site. Available at: http://info.cancerresearchuk.org/cancerstats/types/vulva/incidence/. Accessed October 30, 2013.
7. Jones RW, Joura EA. Analyzing prior clinical events at presentation in 102 women with vulvar carcinoma. Evidence of diagnostic delays. J Reprod Med. 1999;44:766-768.
8. US Preventive Services Task Force. Screening for gonorrhea: recommendation statement. Ann Fam Med. 2005;3:263-267.
9. US Preventive Services Task Force. Screening for chlamydial infection: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2007;147:128-134.
10. US Preventive Services Task Force. Screening for ovarian cancer: recommendation statement. Ann Fam Med. 2004;2:260-262.
11. Committee on Gyencologic Practice. Committee opinion no. 534: well-woman visit. Obstet Gynecol. 2012;120:421-424.
1. Cook RL, Hutchison SL, østergarrd L, et al. Systemic review: noninvasive testing for Chlamydia trachomatis and Neisseria gonorrheoeae. Ann Intern Med. 2005;142:914-925.
2. Padilla LA, Radosevich DM, Milad MP. Accuracy of the pelvic examination in detecting adnexal masses. Obset Gynecol. 2000;96:593-598.
3. Van Nagell JR Jr, DePriest PD, Puls LE, et al. Ovarian cancer screening in asymptomatic postmenopausal women by transvaginal sonography. Cancer. 1991;68:458-462.
4. Andolf E, Jørgensen C, Astedt B. Ultrasound examination for detection of ovarian carcinoma in risk groups. Obstet Gyenocol. 1990;75:106-109.
5. Stewart FH, Harper CC, Ellerston CE, et al. Clinical breast and pelvic examination requirements for hormonal contraception: current practice vs evidence. JAMA. 2001;285:2232-2239.
6. CancerResearchUK. Vulval cancer incidence statistics. Cancer Research UK Web site. Available at: http://info.cancerresearchuk.org/cancerstats/types/vulva/incidence/. Accessed October 30, 2013.
7. Jones RW, Joura EA. Analyzing prior clinical events at presentation in 102 women with vulvar carcinoma. Evidence of diagnostic delays. J Reprod Med. 1999;44:766-768.
8. US Preventive Services Task Force. Screening for gonorrhea: recommendation statement. Ann Fam Med. 2005;3:263-267.
9. US Preventive Services Task Force. Screening for chlamydial infection: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2007;147:128-134.
10. US Preventive Services Task Force. Screening for ovarian cancer: recommendation statement. Ann Fam Med. 2004;2:260-262.
11. Committee on Gyencologic Practice. Committee opinion no. 534: well-woman visit. Obstet Gynecol. 2012;120:421-424.
Evidence-based answers from the Family Physicians Inquiries Network
How should we manage a patient with a positive PPD and prior BCG vaccination?
Prior bacille Calmette-Guérin (BCG) vaccination increases the likelihood of a positive tuberculosis (TB) 5TU purified protein derivative (PPD) skin test. The PPD response following BCG vaccine varies with age at vaccination, number of years since the BCG vaccination, number of times vaccinated, and number of PPDs performed. An induration of greater than 14 mm is unlikely to be due to prior BCG vaccination (strength of recommendation [SOR]: A, based on meta-analysis of validation cohort studies).
The variable reaction after BCG vaccination, along with the desire to detect all cases of TB, has led to recommendations that all patients with a positive PPD test be treated as true positives. These patients should undergo chest radiography and appropriate treatment, regardless of history of BCG vaccine (SOR: B, extrapolation from level 1 study).
A recently developed alternative is the interferon-gamma assay (QuantiFERON-TB Gold test), which may be used in place of, or in addition to, the PPD skin test for patients who are known to have received a BCG vaccine (SOR: B, extrapolation from a validation cohort study).
Disregard history of BCG immunization when evaluating positive PPDs among immigrants
Drew Malloy, MD
University of California Santa Cruz Student Health Service, Santa Cruz, Calif
When I was in residency in Seattle, the experts at the King County TB clinic advised disregarding the history of BCG immunization when evaluating positive PPDs among immigrants. The authors of this review provide evidence confirming this policy. The only new option for helping your patients in weighing the pros and cons of chemoprophylaxis for latent TB is the new interferon-gamma assay. While 3 times the cost of a PPD, it is a reasonable option for patients who want more specific evidence of latent infection before taking 6 to 9 months of a potentially toxic therapy.
I can think of many situations where the specificity of this test may have persuaded some patients to undertake treatment and spared others the risks and inconvenience of isoniazid.
Evidence summary
In areas where tuberculosis is prevalent, the World Health Organization recommends BCG vaccination at birth, without booster doses, to prevent childhood complications of TB infection;1 however, the vaccine’s efficacy is known to be inconsistent. Though BCG vaccine given at birth can decrease the risk of miliary TB and TB meningitis among children, estimates of its effectiveness in preventing adult pulmonary TB range widely from 0% to 80%.1
Though prior BCG vaccination increases the risk of a reactive PPD, this effect is also known to be inconsistent. A 2002 meta-analysis showed that the person’s age at the time of their BCG vaccination and the years since vaccination influence the relative risk of a positive PPD (TABLE). The highest relative risk of a positive PPD occurred among patients who received BCG vaccination after infancy and within 15 years of the PPD testing. This same meta-analysis also examined the significance of the size of the PPD response; a subset of 4 studies showed that equal proportions of BCG vaccinated and unvaccinated patients had indurations of 14 mm or more.2
BCG vaccine may confound PPD readings, but several studies indicate that PPD can still be a useful screening tool for tuberculosis infection after vaccination. A Brazilian case-control study found that reactions by those BCG recipients later exposed to TB were significantly greater than those with no TB exposure.3 The study noted that 47.5% of exposed children (defined as those with a household contact) had PPD readings of >10 mm, compared with just 3.6% of control children. In a Quebec cohort of 1198 foreign-born children and young adults, prior BCG vaccination could account for 50% of PPDs with induration of 5 to 9 mm, but only 4% of reactions 10 mm or greater. This study also showed that patients from countries with a high or moderate incidence of TB were more likely to have reactive PPDs than those from countries of low incidence, suggesting that exposure to TB accounts for some of the positive PPDs.4
Where it is available, the QuantiFERON-TB Gold test may be used in place of, or in addition to, the PPD for patients who are known to have received a BCG vaccine. This blood test detects interferon-gamma in the serum of people sensitized to Mycobacterium tuberculosis. Because the test is specific to proteins found in M tuberculosis, there is no cross-reactivity with BCG. A Japanese study of 216 BCG-vaccinated individuals showed interferon-gamma assays to be 98.1% specific. The same study reported 89.0% sensitivity for the combination of 2 interferon-gamma assays among 118 TB culture-confirmed individuals.5 A published report estimated the cost to the health care system per patient tested by a single interferon-gamma release assay as $33.67, compared with approximately $11 for PPD testing.6
TABLE
PPD reactions >10 mm when BCG was given during and after infancy
| RECEIVED BCG | NO BCG | RR | (95% CI) | |
|---|---|---|---|---|
| Given in infancy | ||||
| Timing of PPD unspecified | 22.3% | 19.2% | 1.16 | (1.09–1.23) |
| PPD less than 15 yrs since BCG | 12.6% | 5.2% | 2.4 | (2.00–2.97) |
| PPD more than 15 yrs since BCG | 47.2% | 41.0% | 1.2 | (1.09–1.22) |
| Given after infancy | ||||
| Timing of PPD unspecified | 35.6% | 17.4% | 2.08 | (1.89–2.21) |
| PPD less than 15 yrs since BCG | 29.1% | 2.9% | 10 | (5.29–18.99) |
| PPD more than 15 yrs since BCG | 37.6% | 47.8% | 0.8 | (0.74–0.85) |
| PPD, purified protein derivative; BCG, bacille Calmette-Guérin; RR, relative risk; CI, confidence interval | ||||
Recommendations from others
While the US Preventive Services Task Force (USPSTF) does not make a specific recommendation regarding PPD readings after BCG vaccine, it does recommend screening high-risk populations. The USPSTF further notes that reactions >10 mm should not be attributed to prior BCG vaccine.7
The Centers for Disease Control and Prevention (CDC) and American Thoracic Society joint statement recommends against altering guidelines for testing and interpretation among BCG recipients.8 In 2005, the CDC recommended the QuantiFERON-TB Gold test be used under the same indications as the PPD, noting its potential benefit among those previously immunized with BCG.9
1. Fine P, Carnelro IA, Milstien JB, Clements CJ. Issues relating to the use of BCG immunization programmes. WHO discussion document. V&B 99.23. Available at: who.int/vaccine_research/documents/en/bcg_vaccines.pdf. Accessed on July 6, 2006.
2. Wang L, Turner MO, Elwood RK, Schulzer M, FitzGerald JM. A meta-analysis of the effect of Bacille Calmette Guerin vaccination on tuberculin skin test measurements. Thorax 2002;57:804-809.[Erratum in: Thorax 2003; 58:188.]
3. Almeida LM, Barbieri MA, Da Paixao AC, Cuevas LE. Use of purified protein derivative to assess the risk of infection in children in close contact with adults with tuberculosis in a population with high Calmette-Guérin bacillus coverage. Ped Inf Dis J 2001;20:1061-1065.
4. Menzies R, Vissandjee B, Amyot D. Factors associated with tuberculin reactivity among the foreign-born in Montreal. Am Rev Respir Dis 1992;146:752-756.
5. Mori T, Sakatani M, Yamagishi F, et al. Specific detection of tuberculosis infection: an interferon-gamma-based assay using new antigens. Am J Respir Crit Care Med 2004;170:59-64.
6. Dewan P, Grinsdale J, Liska S, et al. Feasibility, acceptability, and cost of tuberculosis testing by whole-blood interferon-gamma assay. BMC Infectious Diseases 2006; 6:47. Available at: www.biomedcentral.com/1471-2334/6/47. Accessed on July 6, 2006.
7. US Preventative Services Task Force. Screening for tuberculosis infection, including Bacille Calmette-Guérin immunization. Guide to Clinical Preventative Services; 1996. Available at: www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat3.section.10931#13112.
8. American Thoracic Society and Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med 2000;161:1376-1395.
9. Centers for Disease Control and Prevention. Guidelines for using the QuantiFERON-TB Gold test for detecting Mycobacterium tuberculosis infection, United States. MMWR Recomm Rep 2005;54(RR-15):49-55.
Prior bacille Calmette-Guérin (BCG) vaccination increases the likelihood of a positive tuberculosis (TB) 5TU purified protein derivative (PPD) skin test. The PPD response following BCG vaccine varies with age at vaccination, number of years since the BCG vaccination, number of times vaccinated, and number of PPDs performed. An induration of greater than 14 mm is unlikely to be due to prior BCG vaccination (strength of recommendation [SOR]: A, based on meta-analysis of validation cohort studies).
The variable reaction after BCG vaccination, along with the desire to detect all cases of TB, has led to recommendations that all patients with a positive PPD test be treated as true positives. These patients should undergo chest radiography and appropriate treatment, regardless of history of BCG vaccine (SOR: B, extrapolation from level 1 study).
A recently developed alternative is the interferon-gamma assay (QuantiFERON-TB Gold test), which may be used in place of, or in addition to, the PPD skin test for patients who are known to have received a BCG vaccine (SOR: B, extrapolation from a validation cohort study).
Disregard history of BCG immunization when evaluating positive PPDs among immigrants
Drew Malloy, MD
University of California Santa Cruz Student Health Service, Santa Cruz, Calif
When I was in residency in Seattle, the experts at the King County TB clinic advised disregarding the history of BCG immunization when evaluating positive PPDs among immigrants. The authors of this review provide evidence confirming this policy. The only new option for helping your patients in weighing the pros and cons of chemoprophylaxis for latent TB is the new interferon-gamma assay. While 3 times the cost of a PPD, it is a reasonable option for patients who want more specific evidence of latent infection before taking 6 to 9 months of a potentially toxic therapy.
I can think of many situations where the specificity of this test may have persuaded some patients to undertake treatment and spared others the risks and inconvenience of isoniazid.
Evidence summary
In areas where tuberculosis is prevalent, the World Health Organization recommends BCG vaccination at birth, without booster doses, to prevent childhood complications of TB infection;1 however, the vaccine’s efficacy is known to be inconsistent. Though BCG vaccine given at birth can decrease the risk of miliary TB and TB meningitis among children, estimates of its effectiveness in preventing adult pulmonary TB range widely from 0% to 80%.1
Though prior BCG vaccination increases the risk of a reactive PPD, this effect is also known to be inconsistent. A 2002 meta-analysis showed that the person’s age at the time of their BCG vaccination and the years since vaccination influence the relative risk of a positive PPD (TABLE). The highest relative risk of a positive PPD occurred among patients who received BCG vaccination after infancy and within 15 years of the PPD testing. This same meta-analysis also examined the significance of the size of the PPD response; a subset of 4 studies showed that equal proportions of BCG vaccinated and unvaccinated patients had indurations of 14 mm or more.2
BCG vaccine may confound PPD readings, but several studies indicate that PPD can still be a useful screening tool for tuberculosis infection after vaccination. A Brazilian case-control study found that reactions by those BCG recipients later exposed to TB were significantly greater than those with no TB exposure.3 The study noted that 47.5% of exposed children (defined as those with a household contact) had PPD readings of >10 mm, compared with just 3.6% of control children. In a Quebec cohort of 1198 foreign-born children and young adults, prior BCG vaccination could account for 50% of PPDs with induration of 5 to 9 mm, but only 4% of reactions 10 mm or greater. This study also showed that patients from countries with a high or moderate incidence of TB were more likely to have reactive PPDs than those from countries of low incidence, suggesting that exposure to TB accounts for some of the positive PPDs.4
Where it is available, the QuantiFERON-TB Gold test may be used in place of, or in addition to, the PPD for patients who are known to have received a BCG vaccine. This blood test detects interferon-gamma in the serum of people sensitized to Mycobacterium tuberculosis. Because the test is specific to proteins found in M tuberculosis, there is no cross-reactivity with BCG. A Japanese study of 216 BCG-vaccinated individuals showed interferon-gamma assays to be 98.1% specific. The same study reported 89.0% sensitivity for the combination of 2 interferon-gamma assays among 118 TB culture-confirmed individuals.5 A published report estimated the cost to the health care system per patient tested by a single interferon-gamma release assay as $33.67, compared with approximately $11 for PPD testing.6
TABLE
PPD reactions >10 mm when BCG was given during and after infancy
| RECEIVED BCG | NO BCG | RR | (95% CI) | |
|---|---|---|---|---|
| Given in infancy | ||||
| Timing of PPD unspecified | 22.3% | 19.2% | 1.16 | (1.09–1.23) |
| PPD less than 15 yrs since BCG | 12.6% | 5.2% | 2.4 | (2.00–2.97) |
| PPD more than 15 yrs since BCG | 47.2% | 41.0% | 1.2 | (1.09–1.22) |
| Given after infancy | ||||
| Timing of PPD unspecified | 35.6% | 17.4% | 2.08 | (1.89–2.21) |
| PPD less than 15 yrs since BCG | 29.1% | 2.9% | 10 | (5.29–18.99) |
| PPD more than 15 yrs since BCG | 37.6% | 47.8% | 0.8 | (0.74–0.85) |
| PPD, purified protein derivative; BCG, bacille Calmette-Guérin; RR, relative risk; CI, confidence interval | ||||
Recommendations from others
While the US Preventive Services Task Force (USPSTF) does not make a specific recommendation regarding PPD readings after BCG vaccine, it does recommend screening high-risk populations. The USPSTF further notes that reactions >10 mm should not be attributed to prior BCG vaccine.7
The Centers for Disease Control and Prevention (CDC) and American Thoracic Society joint statement recommends against altering guidelines for testing and interpretation among BCG recipients.8 In 2005, the CDC recommended the QuantiFERON-TB Gold test be used under the same indications as the PPD, noting its potential benefit among those previously immunized with BCG.9
Prior bacille Calmette-Guérin (BCG) vaccination increases the likelihood of a positive tuberculosis (TB) 5TU purified protein derivative (PPD) skin test. The PPD response following BCG vaccine varies with age at vaccination, number of years since the BCG vaccination, number of times vaccinated, and number of PPDs performed. An induration of greater than 14 mm is unlikely to be due to prior BCG vaccination (strength of recommendation [SOR]: A, based on meta-analysis of validation cohort studies).
The variable reaction after BCG vaccination, along with the desire to detect all cases of TB, has led to recommendations that all patients with a positive PPD test be treated as true positives. These patients should undergo chest radiography and appropriate treatment, regardless of history of BCG vaccine (SOR: B, extrapolation from level 1 study).
A recently developed alternative is the interferon-gamma assay (QuantiFERON-TB Gold test), which may be used in place of, or in addition to, the PPD skin test for patients who are known to have received a BCG vaccine (SOR: B, extrapolation from a validation cohort study).
Disregard history of BCG immunization when evaluating positive PPDs among immigrants
Drew Malloy, MD
University of California Santa Cruz Student Health Service, Santa Cruz, Calif
When I was in residency in Seattle, the experts at the King County TB clinic advised disregarding the history of BCG immunization when evaluating positive PPDs among immigrants. The authors of this review provide evidence confirming this policy. The only new option for helping your patients in weighing the pros and cons of chemoprophylaxis for latent TB is the new interferon-gamma assay. While 3 times the cost of a PPD, it is a reasonable option for patients who want more specific evidence of latent infection before taking 6 to 9 months of a potentially toxic therapy.
I can think of many situations where the specificity of this test may have persuaded some patients to undertake treatment and spared others the risks and inconvenience of isoniazid.
Evidence summary
In areas where tuberculosis is prevalent, the World Health Organization recommends BCG vaccination at birth, without booster doses, to prevent childhood complications of TB infection;1 however, the vaccine’s efficacy is known to be inconsistent. Though BCG vaccine given at birth can decrease the risk of miliary TB and TB meningitis among children, estimates of its effectiveness in preventing adult pulmonary TB range widely from 0% to 80%.1
Though prior BCG vaccination increases the risk of a reactive PPD, this effect is also known to be inconsistent. A 2002 meta-analysis showed that the person’s age at the time of their BCG vaccination and the years since vaccination influence the relative risk of a positive PPD (TABLE). The highest relative risk of a positive PPD occurred among patients who received BCG vaccination after infancy and within 15 years of the PPD testing. This same meta-analysis also examined the significance of the size of the PPD response; a subset of 4 studies showed that equal proportions of BCG vaccinated and unvaccinated patients had indurations of 14 mm or more.2
BCG vaccine may confound PPD readings, but several studies indicate that PPD can still be a useful screening tool for tuberculosis infection after vaccination. A Brazilian case-control study found that reactions by those BCG recipients later exposed to TB were significantly greater than those with no TB exposure.3 The study noted that 47.5% of exposed children (defined as those with a household contact) had PPD readings of >10 mm, compared with just 3.6% of control children. In a Quebec cohort of 1198 foreign-born children and young adults, prior BCG vaccination could account for 50% of PPDs with induration of 5 to 9 mm, but only 4% of reactions 10 mm or greater. This study also showed that patients from countries with a high or moderate incidence of TB were more likely to have reactive PPDs than those from countries of low incidence, suggesting that exposure to TB accounts for some of the positive PPDs.4
Where it is available, the QuantiFERON-TB Gold test may be used in place of, or in addition to, the PPD for patients who are known to have received a BCG vaccine. This blood test detects interferon-gamma in the serum of people sensitized to Mycobacterium tuberculosis. Because the test is specific to proteins found in M tuberculosis, there is no cross-reactivity with BCG. A Japanese study of 216 BCG-vaccinated individuals showed interferon-gamma assays to be 98.1% specific. The same study reported 89.0% sensitivity for the combination of 2 interferon-gamma assays among 118 TB culture-confirmed individuals.5 A published report estimated the cost to the health care system per patient tested by a single interferon-gamma release assay as $33.67, compared with approximately $11 for PPD testing.6
TABLE
PPD reactions >10 mm when BCG was given during and after infancy
| RECEIVED BCG | NO BCG | RR | (95% CI) | |
|---|---|---|---|---|
| Given in infancy | ||||
| Timing of PPD unspecified | 22.3% | 19.2% | 1.16 | (1.09–1.23) |
| PPD less than 15 yrs since BCG | 12.6% | 5.2% | 2.4 | (2.00–2.97) |
| PPD more than 15 yrs since BCG | 47.2% | 41.0% | 1.2 | (1.09–1.22) |
| Given after infancy | ||||
| Timing of PPD unspecified | 35.6% | 17.4% | 2.08 | (1.89–2.21) |
| PPD less than 15 yrs since BCG | 29.1% | 2.9% | 10 | (5.29–18.99) |
| PPD more than 15 yrs since BCG | 37.6% | 47.8% | 0.8 | (0.74–0.85) |
| PPD, purified protein derivative; BCG, bacille Calmette-Guérin; RR, relative risk; CI, confidence interval | ||||
Recommendations from others
While the US Preventive Services Task Force (USPSTF) does not make a specific recommendation regarding PPD readings after BCG vaccine, it does recommend screening high-risk populations. The USPSTF further notes that reactions >10 mm should not be attributed to prior BCG vaccine.7
The Centers for Disease Control and Prevention (CDC) and American Thoracic Society joint statement recommends against altering guidelines for testing and interpretation among BCG recipients.8 In 2005, the CDC recommended the QuantiFERON-TB Gold test be used under the same indications as the PPD, noting its potential benefit among those previously immunized with BCG.9
1. Fine P, Carnelro IA, Milstien JB, Clements CJ. Issues relating to the use of BCG immunization programmes. WHO discussion document. V&B 99.23. Available at: who.int/vaccine_research/documents/en/bcg_vaccines.pdf. Accessed on July 6, 2006.
2. Wang L, Turner MO, Elwood RK, Schulzer M, FitzGerald JM. A meta-analysis of the effect of Bacille Calmette Guerin vaccination on tuberculin skin test measurements. Thorax 2002;57:804-809.[Erratum in: Thorax 2003; 58:188.]
3. Almeida LM, Barbieri MA, Da Paixao AC, Cuevas LE. Use of purified protein derivative to assess the risk of infection in children in close contact with adults with tuberculosis in a population with high Calmette-Guérin bacillus coverage. Ped Inf Dis J 2001;20:1061-1065.
4. Menzies R, Vissandjee B, Amyot D. Factors associated with tuberculin reactivity among the foreign-born in Montreal. Am Rev Respir Dis 1992;146:752-756.
5. Mori T, Sakatani M, Yamagishi F, et al. Specific detection of tuberculosis infection: an interferon-gamma-based assay using new antigens. Am J Respir Crit Care Med 2004;170:59-64.
6. Dewan P, Grinsdale J, Liska S, et al. Feasibility, acceptability, and cost of tuberculosis testing by whole-blood interferon-gamma assay. BMC Infectious Diseases 2006; 6:47. Available at: www.biomedcentral.com/1471-2334/6/47. Accessed on July 6, 2006.
7. US Preventative Services Task Force. Screening for tuberculosis infection, including Bacille Calmette-Guérin immunization. Guide to Clinical Preventative Services; 1996. Available at: www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat3.section.10931#13112.
8. American Thoracic Society and Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med 2000;161:1376-1395.
9. Centers for Disease Control and Prevention. Guidelines for using the QuantiFERON-TB Gold test for detecting Mycobacterium tuberculosis infection, United States. MMWR Recomm Rep 2005;54(RR-15):49-55.
1. Fine P, Carnelro IA, Milstien JB, Clements CJ. Issues relating to the use of BCG immunization programmes. WHO discussion document. V&B 99.23. Available at: who.int/vaccine_research/documents/en/bcg_vaccines.pdf. Accessed on July 6, 2006.
2. Wang L, Turner MO, Elwood RK, Schulzer M, FitzGerald JM. A meta-analysis of the effect of Bacille Calmette Guerin vaccination on tuberculin skin test measurements. Thorax 2002;57:804-809.[Erratum in: Thorax 2003; 58:188.]
3. Almeida LM, Barbieri MA, Da Paixao AC, Cuevas LE. Use of purified protein derivative to assess the risk of infection in children in close contact with adults with tuberculosis in a population with high Calmette-Guérin bacillus coverage. Ped Inf Dis J 2001;20:1061-1065.
4. Menzies R, Vissandjee B, Amyot D. Factors associated with tuberculin reactivity among the foreign-born in Montreal. Am Rev Respir Dis 1992;146:752-756.
5. Mori T, Sakatani M, Yamagishi F, et al. Specific detection of tuberculosis infection: an interferon-gamma-based assay using new antigens. Am J Respir Crit Care Med 2004;170:59-64.
6. Dewan P, Grinsdale J, Liska S, et al. Feasibility, acceptability, and cost of tuberculosis testing by whole-blood interferon-gamma assay. BMC Infectious Diseases 2006; 6:47. Available at: www.biomedcentral.com/1471-2334/6/47. Accessed on July 6, 2006.
7. US Preventative Services Task Force. Screening for tuberculosis infection, including Bacille Calmette-Guérin immunization. Guide to Clinical Preventative Services; 1996. Available at: www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat3.section.10931#13112.
8. American Thoracic Society and Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med 2000;161:1376-1395.
9. Centers for Disease Control and Prevention. Guidelines for using the QuantiFERON-TB Gold test for detecting Mycobacterium tuberculosis infection, United States. MMWR Recomm Rep 2005;54(RR-15):49-55.
Evidence-based answers from the Family Physicians Inquiries Network
How do we decide when a patient with nonmalignant disease is eligible for hospice care?
Each hospice has its own policy, but Medicare requires 6 months or less life expectancy for certification of eligibility and reimbursement. Other important criteria include patient and family understanding and wishes.
Evidence-based guidelines for determining prognosis in some noncancer diseases have been developed. However, despite their widespread use, limited data exist to support their accuracy (strength of recommendation: B). Moreover, a high degree of prognostic accuracy may be unattainable given the unpredictable course of common noncancer chronic diseases. Hospice eligibility for patients with nonmalignant disease is based on clinical judgment.
Refer to hospice when goals are focused on quality of life rather than intervention
Nancy Havas, MD
Medical Collage of Wisconsin, Milwaukee
Hospice referral with a nonmalignant diagnosis is challenging but essential to quality patient care. Between episodes of disease exacerbations, we need to take an active role in discussing goals of care, remembering that some patients and families need “permission” to palliative goals rather than continuing with aggressive interventions. My gauge of when to refer to hospice is when the goals of care become focused on quality of life and staying out of the hospital rather than intervention in the disease course. Most patients underuse the benefits that a hospice referral can provide, and while some patients outlive the 6-month criteria for hospice care, this benefit can be renewed if the patient still meets the criteria.
Evidence summary
Hospices have varying admission criteria. However, according to US law, patients must be certified to be “terminally ill” with a prognosis of less than 6 months to live in order to qualify for the Medicare hospice benefit.1 US law and Medicare regulations specify that an attending physician and the accepting hospice medical director must agree to the prognosis for certification of eligibility.
Brickner et al’s survey2 demonstrated that physicians find accurate prognostication difficult. Furthermore, many of the common noncancer diseases have erratic and unpredictable courses, making prognosis even harder. Indeed, patients with noncancer diagnoses are typically admitted to hospices later in their terminal course, 3 resulting in increased inpatient hospital stays4 and ultimately lower patient and family satisfaction. 5 The difficulties inherent in prognostication were underscored by a study that found patients with non-cancer diagnoses to be much more likely to be discharged from hospice alive.6
The National Hospice Organization (NHO) has created guidelines7 for determining prognosis in selected noncancer diseases including heart disease, pulmonary disease, dementia, HIV, liver disease, renal disease, stroke, coma, and amyotrophic lateral sclerosis (ALS). To validate these guidelines, one group identified 2607 patients who meet the NHO guidelines.8 Only 655 (25%) were dead within 6 months. The estimated median survival of these identified patients was 804 days. When every potential prognostic criterion was met (far more than NHO standards) only 19 of the 2607 patients qualified for hospice, and yet 10 of them were still alive at 6 months. Unlike many cancers, in which there is a steady terminal decline, diseases such as chronic obstructive pulmonary disease, congestive heart failure, and liver failure are characterized by a baseline of moderate functioning with intermittent—often life-threatening—exacerbations.
A recent Clinical Inquiry9 addressed the issue of hospice care for patients with late-stage Alzheimer’s disease. That evidence-based answer concluded that criteria superior to the NHO guidelines or clinical judgment had been established for prognosis of Alzheimer’s disease. However, using those improved criteria yielded only marginally more accurate prognostication. At best, 71% of the patients predicted to live less than 6 months did so, but only if the patients had progressed through the disease in an orderly fashion. For the larger subset of patients, those who did not progress through Alzheimer’s in a predictable way, only 30% of the patients actually died within 6 months.
Recommendations from others
The NHO7 provides parameters to help determine a 6-month life expectancy. The “General Guidelines for Determining Prognosis” are summarized in the TABLE. Further details of the “general guidelines” as well as guidelines for prognosis in specific diseases (heart disease, pulmonary disease, dementia, HIV, liver disease, renal disease, stroke, coma, and ALS) are outlined by the NHO.7
TABLE
Hospice criteria
Patients should meet all of the following criteria:
|
1. Social Security Act. 55 FR 50834 (1990), as amended at 57 FR 36017 (1992) (codified at 42 CFR 418.22).
2. Brickner L, Scannell K, Marquet S, Ackerson L. Barriers to hospice care and referrals: survey of physicians’ knowledge, attitudes, and perceptions in a health maintenance organization. J Palliat Med 2004;7:411-418.
3. Farnon C, Hofmann M. Factors contributing to late hospice admission and proposals for change. Am J Hosp Palliat Care 1997;14:212-218.
4. Miller SC, Kinzbrunner B, Pettit P, Williams JR. How does the timing of hospice referral influence hospice care in the last days of life? J Am Geriatr Soc 2003;51:798-806.
5. Rickerson E, Harrold J, Kapo J, Carroll JT, Casarett D. Timing of hospice referral and families’ perceptions of services: are earlier hospice referrals better? J Am Geriatr Soc 2005;53:819-523.
6. Kutner JS, Meyer SA, Beaty BL, Kassner CT, Nowels DE, Beehler C. Outcomes and characteristics of patients discharged alive from hospice. J Am Geriatr Soc 2004;52:1337-1342.
7. National Hospice Organization Standards and Accreditation Committee Medical Guidelines Task Force. Medical Guidelines for Determining Prognosis in Selected Non-Cancer Diseases. Hosp J 1996;11:47-63.
8. Fox E, Landrum-McNiff K, Zhong Z, Dawson NV, Wu AW, Lynn J. Evaluation of prognostic criteria for determining hospice eligibility in patients with advanced lung, heart, or liver disease. SUPPORT Investigators. Study to Understand Prognoses and P for Outcomes and Risks of Treatments. JAMA 1999;282:1638-1645
9. Modi S, Moore C, Shah K. Which late-stage Alzheimer’s patients should be referred for hospice care? J Fam Pract 2005;54:984-986.
Each hospice has its own policy, but Medicare requires 6 months or less life expectancy for certification of eligibility and reimbursement. Other important criteria include patient and family understanding and wishes.
Evidence-based guidelines for determining prognosis in some noncancer diseases have been developed. However, despite their widespread use, limited data exist to support their accuracy (strength of recommendation: B). Moreover, a high degree of prognostic accuracy may be unattainable given the unpredictable course of common noncancer chronic diseases. Hospice eligibility for patients with nonmalignant disease is based on clinical judgment.
Refer to hospice when goals are focused on quality of life rather than intervention
Nancy Havas, MD
Medical Collage of Wisconsin, Milwaukee
Hospice referral with a nonmalignant diagnosis is challenging but essential to quality patient care. Between episodes of disease exacerbations, we need to take an active role in discussing goals of care, remembering that some patients and families need “permission” to palliative goals rather than continuing with aggressive interventions. My gauge of when to refer to hospice is when the goals of care become focused on quality of life and staying out of the hospital rather than intervention in the disease course. Most patients underuse the benefits that a hospice referral can provide, and while some patients outlive the 6-month criteria for hospice care, this benefit can be renewed if the patient still meets the criteria.
Evidence summary
Hospices have varying admission criteria. However, according to US law, patients must be certified to be “terminally ill” with a prognosis of less than 6 months to live in order to qualify for the Medicare hospice benefit.1 US law and Medicare regulations specify that an attending physician and the accepting hospice medical director must agree to the prognosis for certification of eligibility.
Brickner et al’s survey2 demonstrated that physicians find accurate prognostication difficult. Furthermore, many of the common noncancer diseases have erratic and unpredictable courses, making prognosis even harder. Indeed, patients with noncancer diagnoses are typically admitted to hospices later in their terminal course, 3 resulting in increased inpatient hospital stays4 and ultimately lower patient and family satisfaction. 5 The difficulties inherent in prognostication were underscored by a study that found patients with non-cancer diagnoses to be much more likely to be discharged from hospice alive.6
The National Hospice Organization (NHO) has created guidelines7 for determining prognosis in selected noncancer diseases including heart disease, pulmonary disease, dementia, HIV, liver disease, renal disease, stroke, coma, and amyotrophic lateral sclerosis (ALS). To validate these guidelines, one group identified 2607 patients who meet the NHO guidelines.8 Only 655 (25%) were dead within 6 months. The estimated median survival of these identified patients was 804 days. When every potential prognostic criterion was met (far more than NHO standards) only 19 of the 2607 patients qualified for hospice, and yet 10 of them were still alive at 6 months. Unlike many cancers, in which there is a steady terminal decline, diseases such as chronic obstructive pulmonary disease, congestive heart failure, and liver failure are characterized by a baseline of moderate functioning with intermittent—often life-threatening—exacerbations.
A recent Clinical Inquiry9 addressed the issue of hospice care for patients with late-stage Alzheimer’s disease. That evidence-based answer concluded that criteria superior to the NHO guidelines or clinical judgment had been established for prognosis of Alzheimer’s disease. However, using those improved criteria yielded only marginally more accurate prognostication. At best, 71% of the patients predicted to live less than 6 months did so, but only if the patients had progressed through the disease in an orderly fashion. For the larger subset of patients, those who did not progress through Alzheimer’s in a predictable way, only 30% of the patients actually died within 6 months.
Recommendations from others
The NHO7 provides parameters to help determine a 6-month life expectancy. The “General Guidelines for Determining Prognosis” are summarized in the TABLE. Further details of the “general guidelines” as well as guidelines for prognosis in specific diseases (heart disease, pulmonary disease, dementia, HIV, liver disease, renal disease, stroke, coma, and ALS) are outlined by the NHO.7
TABLE
Hospice criteria
Patients should meet all of the following criteria:
|
Each hospice has its own policy, but Medicare requires 6 months or less life expectancy for certification of eligibility and reimbursement. Other important criteria include patient and family understanding and wishes.
Evidence-based guidelines for determining prognosis in some noncancer diseases have been developed. However, despite their widespread use, limited data exist to support their accuracy (strength of recommendation: B). Moreover, a high degree of prognostic accuracy may be unattainable given the unpredictable course of common noncancer chronic diseases. Hospice eligibility for patients with nonmalignant disease is based on clinical judgment.
Refer to hospice when goals are focused on quality of life rather than intervention
Nancy Havas, MD
Medical Collage of Wisconsin, Milwaukee
Hospice referral with a nonmalignant diagnosis is challenging but essential to quality patient care. Between episodes of disease exacerbations, we need to take an active role in discussing goals of care, remembering that some patients and families need “permission” to palliative goals rather than continuing with aggressive interventions. My gauge of when to refer to hospice is when the goals of care become focused on quality of life and staying out of the hospital rather than intervention in the disease course. Most patients underuse the benefits that a hospice referral can provide, and while some patients outlive the 6-month criteria for hospice care, this benefit can be renewed if the patient still meets the criteria.
Evidence summary
Hospices have varying admission criteria. However, according to US law, patients must be certified to be “terminally ill” with a prognosis of less than 6 months to live in order to qualify for the Medicare hospice benefit.1 US law and Medicare regulations specify that an attending physician and the accepting hospice medical director must agree to the prognosis for certification of eligibility.
Brickner et al’s survey2 demonstrated that physicians find accurate prognostication difficult. Furthermore, many of the common noncancer diseases have erratic and unpredictable courses, making prognosis even harder. Indeed, patients with noncancer diagnoses are typically admitted to hospices later in their terminal course, 3 resulting in increased inpatient hospital stays4 and ultimately lower patient and family satisfaction. 5 The difficulties inherent in prognostication were underscored by a study that found patients with non-cancer diagnoses to be much more likely to be discharged from hospice alive.6
The National Hospice Organization (NHO) has created guidelines7 for determining prognosis in selected noncancer diseases including heart disease, pulmonary disease, dementia, HIV, liver disease, renal disease, stroke, coma, and amyotrophic lateral sclerosis (ALS). To validate these guidelines, one group identified 2607 patients who meet the NHO guidelines.8 Only 655 (25%) were dead within 6 months. The estimated median survival of these identified patients was 804 days. When every potential prognostic criterion was met (far more than NHO standards) only 19 of the 2607 patients qualified for hospice, and yet 10 of them were still alive at 6 months. Unlike many cancers, in which there is a steady terminal decline, diseases such as chronic obstructive pulmonary disease, congestive heart failure, and liver failure are characterized by a baseline of moderate functioning with intermittent—often life-threatening—exacerbations.
A recent Clinical Inquiry9 addressed the issue of hospice care for patients with late-stage Alzheimer’s disease. That evidence-based answer concluded that criteria superior to the NHO guidelines or clinical judgment had been established for prognosis of Alzheimer’s disease. However, using those improved criteria yielded only marginally more accurate prognostication. At best, 71% of the patients predicted to live less than 6 months did so, but only if the patients had progressed through the disease in an orderly fashion. For the larger subset of patients, those who did not progress through Alzheimer’s in a predictable way, only 30% of the patients actually died within 6 months.
Recommendations from others
The NHO7 provides parameters to help determine a 6-month life expectancy. The “General Guidelines for Determining Prognosis” are summarized in the TABLE. Further details of the “general guidelines” as well as guidelines for prognosis in specific diseases (heart disease, pulmonary disease, dementia, HIV, liver disease, renal disease, stroke, coma, and ALS) are outlined by the NHO.7
TABLE
Hospice criteria
Patients should meet all of the following criteria:
|
1. Social Security Act. 55 FR 50834 (1990), as amended at 57 FR 36017 (1992) (codified at 42 CFR 418.22).
2. Brickner L, Scannell K, Marquet S, Ackerson L. Barriers to hospice care and referrals: survey of physicians’ knowledge, attitudes, and perceptions in a health maintenance organization. J Palliat Med 2004;7:411-418.
3. Farnon C, Hofmann M. Factors contributing to late hospice admission and proposals for change. Am J Hosp Palliat Care 1997;14:212-218.
4. Miller SC, Kinzbrunner B, Pettit P, Williams JR. How does the timing of hospice referral influence hospice care in the last days of life? J Am Geriatr Soc 2003;51:798-806.
5. Rickerson E, Harrold J, Kapo J, Carroll JT, Casarett D. Timing of hospice referral and families’ perceptions of services: are earlier hospice referrals better? J Am Geriatr Soc 2005;53:819-523.
6. Kutner JS, Meyer SA, Beaty BL, Kassner CT, Nowels DE, Beehler C. Outcomes and characteristics of patients discharged alive from hospice. J Am Geriatr Soc 2004;52:1337-1342.
7. National Hospice Organization Standards and Accreditation Committee Medical Guidelines Task Force. Medical Guidelines for Determining Prognosis in Selected Non-Cancer Diseases. Hosp J 1996;11:47-63.
8. Fox E, Landrum-McNiff K, Zhong Z, Dawson NV, Wu AW, Lynn J. Evaluation of prognostic criteria for determining hospice eligibility in patients with advanced lung, heart, or liver disease. SUPPORT Investigators. Study to Understand Prognoses and P for Outcomes and Risks of Treatments. JAMA 1999;282:1638-1645
9. Modi S, Moore C, Shah K. Which late-stage Alzheimer’s patients should be referred for hospice care? J Fam Pract 2005;54:984-986.
1. Social Security Act. 55 FR 50834 (1990), as amended at 57 FR 36017 (1992) (codified at 42 CFR 418.22).
2. Brickner L, Scannell K, Marquet S, Ackerson L. Barriers to hospice care and referrals: survey of physicians’ knowledge, attitudes, and perceptions in a health maintenance organization. J Palliat Med 2004;7:411-418.
3. Farnon C, Hofmann M. Factors contributing to late hospice admission and proposals for change. Am J Hosp Palliat Care 1997;14:212-218.
4. Miller SC, Kinzbrunner B, Pettit P, Williams JR. How does the timing of hospice referral influence hospice care in the last days of life? J Am Geriatr Soc 2003;51:798-806.
5. Rickerson E, Harrold J, Kapo J, Carroll JT, Casarett D. Timing of hospice referral and families’ perceptions of services: are earlier hospice referrals better? J Am Geriatr Soc 2005;53:819-523.
6. Kutner JS, Meyer SA, Beaty BL, Kassner CT, Nowels DE, Beehler C. Outcomes and characteristics of patients discharged alive from hospice. J Am Geriatr Soc 2004;52:1337-1342.
7. National Hospice Organization Standards and Accreditation Committee Medical Guidelines Task Force. Medical Guidelines for Determining Prognosis in Selected Non-Cancer Diseases. Hosp J 1996;11:47-63.
8. Fox E, Landrum-McNiff K, Zhong Z, Dawson NV, Wu AW, Lynn J. Evaluation of prognostic criteria for determining hospice eligibility in patients with advanced lung, heart, or liver disease. SUPPORT Investigators. Study to Understand Prognoses and P for Outcomes and Risks of Treatments. JAMA 1999;282:1638-1645
9. Modi S, Moore C, Shah K. Which late-stage Alzheimer’s patients should be referred for hospice care? J Fam Pract 2005;54:984-986.
Evidence-based answers from the Family Physicians Inquiries Network