Zika virus transmission continues at a rapid clip as the number of new cases among pregnant women topped 200 again for the week ending Sept. 22, according to the Centers for Disease Control and Prevention.

After setting a new high of 210 the previous week, there were 201 new cases of pregnant women with laboratory-confirmed Zika infection for the week ending Sept. 22. There were 59 new cases in the 50 states and the District of Columbia and 142 new cases in the U.S. territories, the CDC reported Sept. 29. In the United States this year, there have been 2,298 reported cases of Zika-infected pregnant women: 808 in the states and D.C. and 1,490 in the territories.

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Zika virus transmission continues at a rapid clip as the number of new cases among pregnant women topped 200 again for the week ending Sept. 22, according to the Centers for Disease Control and Prevention.

After setting a new high of 210 the previous week, there were 201 new cases of pregnant women with laboratory-confirmed Zika infection for the week ending Sept. 22. There were 59 new cases in the 50 states and the District of Columbia and 142 new cases in the U.S. territories, the CDC reported Sept. 29. In the United States this year, there have been 2,298 reported cases of Zika-infected pregnant women: 808 in the states and D.C. and 1,490 in the territories.

[email protected]

Zika virus transmission continues at a rapid clip as the number of new cases among pregnant women topped 200 again for the week ending Sept. 22, according to the Centers for Disease Control and Prevention.

After setting a new high of 210 the previous week, there were 201 new cases of pregnant women with laboratory-confirmed Zika infection for the week ending Sept. 22. There were 59 new cases in the 50 states and the District of Columbia and 142 new cases in the U.S. territories, the CDC reported Sept. 29. In the United States this year, there have been 2,298 reported cases of Zika-infected pregnant women: 808 in the states and D.C. and 1,490 in the territories.

[email protected]

As reviewed in Part 1, surgery is indicated for the staging and treatment of endometrial cancer. Lymph node status is one of the most important factors in determining prognosis and the need for adjuvant treatment. The extent of lymph node evaluation is controversial as full lymphadenectomy carries risks, including increased operative time, blood loss, nerve injury, and lymphedema.

Two trials have found no survival benefit from lymphadenectomy for endometrial cancer; however, other evidence suggests that women without known nodal status may be more likely to receive radiotherapy.^1,2,3

Given these issues, the sentinel lymph node technique strikes a balance between the risks and benefits of lymph node evaluation in endometrial cancer.

Sentinel lymph nodes (SLN) are the first nodes to drain a tumor site, and thus, are typically the first to demonstrate occult malignancy. The use of the SLN technique as an alternative to complete lymphadenectomy in endometrial cancer has been well described, although its accuracy and the validity of its use are still debated.

The viability of the SLN technique is predicated on the ability to achieve mapping of dye or tracer from the tumor to the first lymph node to drain the tumor. The lymphatic drainage of the endometrium is complex and unlike vulvar or breast cancer, endometrial cancer is less accessible for peritumoral injection. Several injection techniques have been described; cervical injection is the easiest to achieve and has been found to have similar or higher SLN detection than hysteroscopic or fundal injections.^4,5

There are a number of techniques for SLN detection, each with unique benefits and risks. Visual identification of blue dye, most frequently isosulfan blue, is the “colorimetric method” and has been used most commonly with cervical injection for endometrial cancer. Injection of isosulfan blue does not require specialized equipment, however visualization in obese patients is inferior.⁶

Technetium sulfur colloid (Tc) is a radioactive tracer that can be detected by gamma probes. A preoperative lymphoscintigraphy and a handheld gamma probe are used to map lymphatics. This technique has limitations, including the additional time and coordination of procedures, as well as some evidence of poor correlation between lymphoscintigraphy and surgical SLN mapping.⁷

Indocyanine green (ICG) is a fluorescent dye that has excellent signal penetration and allows for real-time visual identification using near-infrared fluorescence imaging. The bilateral detection rate with ICG appears comparable or better than blue dye.⁸ Combinations of dye, either ICG plus Tc or Tc plus blue dye, may be also used to increase SLN detection.

The accuracy of the SLN technique is the cornerstone to its success. In a prospective multicenter study – Senti-Endo – patients with early-stage disease underwent pelvic SLN assessment with cervical injection of a combination of dyes followed by systematic pelvic node dissection. The overall negative predictive value was 97% with three patients who had positive lymph nodes that were not detected, all of whom had a type 2 endometrial cancer.⁹

With the uptake of the SLN technique, many institutions have protocols surrounding the technique to ensure appropriate SLN detection and evaluation. Physicians using this technique should adhere to protocols supported by National Comprehensive Cancer Network guidelines, taking care to remove any suspicious lymph nodes and perform a full side-specific lymphadenectomy if bilateral mapping is not achieved.

The extent of lymphadenectomy and application of the SLN technique in high-risk endometrial cancer remains controversial. These patients are at higher risk for unsuccessful mapping and isolated para-aortic metastasis. Retrospective series have suggested equivalent oncologic outcomes for women with high-grade cancers who have been staged by SLN biopsy, compared with selective or complete lymphadenectomy.^10,11

We await the results of a large prospective trial in which patients undergo comprehensive lymphadenectomy in addition to SLN biopsy to assess the accuracy of the technique (NCT01673022).

Pathologic evaluation of SLNs is frequently done with ultrastaging, which describes additional sectioning and staining of the node. This technique frequently identifies isolated tumor cells and micrometastasis (collectively called low-volume disease) in addition to macrometastasis. The clinical and prognostic significance of low-volume disease is unknown and additional investigation is urgently needed to determine appropriate adjuvant therapy and follow-up for these patients.

The SLN technique is an acceptable approach to assess clinical stage I endometrial cancer. Physicians should consider adding the SLN biopsy to their routine staging techniques prior to exclusively adopting the new technique. They should take care to adhere to SLN algorithms and monitor outcomes.

References

1. J Natl Cancer Inst. 2008;100(23):1707-16.

2. Lancet. 2009 Jan;373(9658):125-36.

3. Am J Obstet Gynecol. 2011 Dec;205(6):562.e1–9.

4. Gynecol Oncol. 2013 Nov;131(2):299-303.

5. Int J Gynecol Cancer. 2013 Nov;23(9):1704-11.

6. Gynecol Oncol 2014 Aug;134(2):281-6.

7. Gynecol Oncol. 2009 Feb;112(2):348-352.

8. Gynecol Oncol. 2014 May;133(2):274-7.

9. Lancet Oncol. 2011 May;12(5):469-76.

10. Ann Surg Oncol. 2016 Jan;23(1):196-202.

11. Gynecol Oncol. 2016 Mar;140(3):394-9.

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina, Chapel Hill. Dr. Sullivan is a clinical fellow in the division of gynecologic oncology at UNC, Chapel Hill. Dr. Rossi and Dr. Sullivan reported having no relevant financial disclosures.

As reviewed in Part 1, surgery is indicated for the staging and treatment of endometrial cancer. Lymph node status is one of the most important factors in determining prognosis and the need for adjuvant treatment. The extent of lymph node evaluation is controversial as full lymphadenectomy carries risks, including increased operative time, blood loss, nerve injury, and lymphedema.

Two trials have found no survival benefit from lymphadenectomy for endometrial cancer; however, other evidence suggests that women without known nodal status may be more likely to receive radiotherapy.^1,2,3

Given these issues, the sentinel lymph node technique strikes a balance between the risks and benefits of lymph node evaluation in endometrial cancer.

Sentinel lymph nodes (SLN) are the first nodes to drain a tumor site, and thus, are typically the first to demonstrate occult malignancy. The use of the SLN technique as an alternative to complete lymphadenectomy in endometrial cancer has been well described, although its accuracy and the validity of its use are still debated.

The viability of the SLN technique is predicated on the ability to achieve mapping of dye or tracer from the tumor to the first lymph node to drain the tumor. The lymphatic drainage of the endometrium is complex and unlike vulvar or breast cancer, endometrial cancer is less accessible for peritumoral injection. Several injection techniques have been described; cervical injection is the easiest to achieve and has been found to have similar or higher SLN detection than hysteroscopic or fundal injections.^4,5

There are a number of techniques for SLN detection, each with unique benefits and risks. Visual identification of blue dye, most frequently isosulfan blue, is the “colorimetric method” and has been used most commonly with cervical injection for endometrial cancer. Injection of isosulfan blue does not require specialized equipment, however visualization in obese patients is inferior.⁶

Technetium sulfur colloid (Tc) is a radioactive tracer that can be detected by gamma probes. A preoperative lymphoscintigraphy and a handheld gamma probe are used to map lymphatics. This technique has limitations, including the additional time and coordination of procedures, as well as some evidence of poor correlation between lymphoscintigraphy and surgical SLN mapping.⁷

Indocyanine green (ICG) is a fluorescent dye that has excellent signal penetration and allows for real-time visual identification using near-infrared fluorescence imaging. The bilateral detection rate with ICG appears comparable or better than blue dye.⁸ Combinations of dye, either ICG plus Tc or Tc plus blue dye, may be also used to increase SLN detection.

The accuracy of the SLN technique is the cornerstone to its success. In a prospective multicenter study – Senti-Endo – patients with early-stage disease underwent pelvic SLN assessment with cervical injection of a combination of dyes followed by systematic pelvic node dissection. The overall negative predictive value was 97% with three patients who had positive lymph nodes that were not detected, all of whom had a type 2 endometrial cancer.⁹

With the uptake of the SLN technique, many institutions have protocols surrounding the technique to ensure appropriate SLN detection and evaluation. Physicians using this technique should adhere to protocols supported by National Comprehensive Cancer Network guidelines, taking care to remove any suspicious lymph nodes and perform a full side-specific lymphadenectomy if bilateral mapping is not achieved.

The extent of lymphadenectomy and application of the SLN technique in high-risk endometrial cancer remains controversial. These patients are at higher risk for unsuccessful mapping and isolated para-aortic metastasis. Retrospective series have suggested equivalent oncologic outcomes for women with high-grade cancers who have been staged by SLN biopsy, compared with selective or complete lymphadenectomy.^10,11

We await the results of a large prospective trial in which patients undergo comprehensive lymphadenectomy in addition to SLN biopsy to assess the accuracy of the technique (NCT01673022).

Pathologic evaluation of SLNs is frequently done with ultrastaging, which describes additional sectioning and staining of the node. This technique frequently identifies isolated tumor cells and micrometastasis (collectively called low-volume disease) in addition to macrometastasis. The clinical and prognostic significance of low-volume disease is unknown and additional investigation is urgently needed to determine appropriate adjuvant therapy and follow-up for these patients.

The SLN technique is an acceptable approach to assess clinical stage I endometrial cancer. Physicians should consider adding the SLN biopsy to their routine staging techniques prior to exclusively adopting the new technique. They should take care to adhere to SLN algorithms and monitor outcomes.

References

1. J Natl Cancer Inst. 2008;100(23):1707-16.

2. Lancet. 2009 Jan;373(9658):125-36.

3. Am J Obstet Gynecol. 2011 Dec;205(6):562.e1–9.

4. Gynecol Oncol. 2013 Nov;131(2):299-303.

5. Int J Gynecol Cancer. 2013 Nov;23(9):1704-11.

6. Gynecol Oncol 2014 Aug;134(2):281-6.

7. Gynecol Oncol. 2009 Feb;112(2):348-352.

8. Gynecol Oncol. 2014 May;133(2):274-7.

9. Lancet Oncol. 2011 May;12(5):469-76.

10. Ann Surg Oncol. 2016 Jan;23(1):196-202.

11. Gynecol Oncol. 2016 Mar;140(3):394-9.

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina, Chapel Hill. Dr. Sullivan is a clinical fellow in the division of gynecologic oncology at UNC, Chapel Hill. Dr. Rossi and Dr. Sullivan reported having no relevant financial disclosures.

As reviewed in Part 1, surgery is indicated for the staging and treatment of endometrial cancer. Lymph node status is one of the most important factors in determining prognosis and the need for adjuvant treatment. The extent of lymph node evaluation is controversial as full lymphadenectomy carries risks, including increased operative time, blood loss, nerve injury, and lymphedema.

Two trials have found no survival benefit from lymphadenectomy for endometrial cancer; however, other evidence suggests that women without known nodal status may be more likely to receive radiotherapy.^1,2,3

Given these issues, the sentinel lymph node technique strikes a balance between the risks and benefits of lymph node evaluation in endometrial cancer.

Sentinel lymph nodes (SLN) are the first nodes to drain a tumor site, and thus, are typically the first to demonstrate occult malignancy. The use of the SLN technique as an alternative to complete lymphadenectomy in endometrial cancer has been well described, although its accuracy and the validity of its use are still debated.

The viability of the SLN technique is predicated on the ability to achieve mapping of dye or tracer from the tumor to the first lymph node to drain the tumor. The lymphatic drainage of the endometrium is complex and unlike vulvar or breast cancer, endometrial cancer is less accessible for peritumoral injection. Several injection techniques have been described; cervical injection is the easiest to achieve and has been found to have similar or higher SLN detection than hysteroscopic or fundal injections.^4,5

There are a number of techniques for SLN detection, each with unique benefits and risks. Visual identification of blue dye, most frequently isosulfan blue, is the “colorimetric method” and has been used most commonly with cervical injection for endometrial cancer. Injection of isosulfan blue does not require specialized equipment, however visualization in obese patients is inferior.⁶

Technetium sulfur colloid (Tc) is a radioactive tracer that can be detected by gamma probes. A preoperative lymphoscintigraphy and a handheld gamma probe are used to map lymphatics. This technique has limitations, including the additional time and coordination of procedures, as well as some evidence of poor correlation between lymphoscintigraphy and surgical SLN mapping.⁷

Indocyanine green (ICG) is a fluorescent dye that has excellent signal penetration and allows for real-time visual identification using near-infrared fluorescence imaging. The bilateral detection rate with ICG appears comparable or better than blue dye.⁸ Combinations of dye, either ICG plus Tc or Tc plus blue dye, may be also used to increase SLN detection.

The accuracy of the SLN technique is the cornerstone to its success. In a prospective multicenter study – Senti-Endo – patients with early-stage disease underwent pelvic SLN assessment with cervical injection of a combination of dyes followed by systematic pelvic node dissection. The overall negative predictive value was 97% with three patients who had positive lymph nodes that were not detected, all of whom had a type 2 endometrial cancer.⁹

With the uptake of the SLN technique, many institutions have protocols surrounding the technique to ensure appropriate SLN detection and evaluation. Physicians using this technique should adhere to protocols supported by National Comprehensive Cancer Network guidelines, taking care to remove any suspicious lymph nodes and perform a full side-specific lymphadenectomy if bilateral mapping is not achieved.

The extent of lymphadenectomy and application of the SLN technique in high-risk endometrial cancer remains controversial. These patients are at higher risk for unsuccessful mapping and isolated para-aortic metastasis. Retrospective series have suggested equivalent oncologic outcomes for women with high-grade cancers who have been staged by SLN biopsy, compared with selective or complete lymphadenectomy.^10,11

We await the results of a large prospective trial in which patients undergo comprehensive lymphadenectomy in addition to SLN biopsy to assess the accuracy of the technique (NCT01673022).

Pathologic evaluation of SLNs is frequently done with ultrastaging, which describes additional sectioning and staining of the node. This technique frequently identifies isolated tumor cells and micrometastasis (collectively called low-volume disease) in addition to macrometastasis. The clinical and prognostic significance of low-volume disease is unknown and additional investigation is urgently needed to determine appropriate adjuvant therapy and follow-up for these patients.

The SLN technique is an acceptable approach to assess clinical stage I endometrial cancer. Physicians should consider adding the SLN biopsy to their routine staging techniques prior to exclusively adopting the new technique. They should take care to adhere to SLN algorithms and monitor outcomes.

References

1. J Natl Cancer Inst. 2008;100(23):1707-16.

2. Lancet. 2009 Jan;373(9658):125-36.

3. Am J Obstet Gynecol. 2011 Dec;205(6):562.e1–9.

4. Gynecol Oncol. 2013 Nov;131(2):299-303.

5. Int J Gynecol Cancer. 2013 Nov;23(9):1704-11.

6. Gynecol Oncol 2014 Aug;134(2):281-6.

7. Gynecol Oncol. 2009 Feb;112(2):348-352.

8. Gynecol Oncol. 2014 May;133(2):274-7.

9. Lancet Oncol. 2011 May;12(5):469-76.

10. Ann Surg Oncol. 2016 Jan;23(1):196-202.

11. Gynecol Oncol. 2016 Mar;140(3):394-9.

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina, Chapel Hill. Dr. Sullivan is a clinical fellow in the division of gynecologic oncology at UNC, Chapel Hill. Dr. Rossi and Dr. Sullivan reported having no relevant financial disclosures.

From her vantage point in medical education, Christine M. Peterson, MD, is acutely aware that well-woman care is at a turning point.

“We’re at an interesting crossroads between tradition and evidence-based practice,” said Dr. Peterson, who practiced obstetrics and gynecology in the 1980s and now serves as associate professor of ob.gyn. and assistant dean for student affairs at the University of Virginia’s School of Medicine in Charlottesville.

Courtesy Bill Tolley/ University of Virginia

“Even young trainees are aware of the traditions for the annual well-woman visit – the Pap, the pelvic, the breast exam,” she said. “But the evidence is pointing us in a different direction ... toward doing only those things that are effective for prevention and early detection of disease, or that have [demonstrated] value in one way or another.”

If all goes as planned at a national level, Dr. Peterson’s students who become ob.gyns., family physicians, and general internists will practice under a reshaped and well-defined umbrella of well-woman care – one that includes a broad array of insurer-covered screening and counseling services.

That umbrella already includes HPV testing, and screening and/or counseling on intimate partner violence, sexually transmitted infections, and HIV, in addition to contraception counseling. These preventive services were described in the Women’s Preventive Services Guidelines and adopted as covered benefits by the Department of Health & Human Services in 2011.

And more change is on the way. In March, the American College of Obstetricians and Gynecologists (ACOG) launched the Women’s Preventive Services Initiative (WPSI) – a broad coalition tasked with recommending updates to the 2011 guidelines and developing new recommendations for the scope and implementation of women’s preventive health care services.

The effort is funded through a 5-year cooperative agreement with the Health Resources & Services Administration (HRSA). It’s similar to the American Academy of Pediatrics’ approach in developing the HRSA-supported Bright Futures guidelines almost 25 years ago. Under the Affordable Care Act, all HRSA-recommended preventive services must be covered by most private insurers without patient cost sharing.

Courtesy Carmen Martinez/ Kaiser Permanente

“Over the years, we’ve gone from an emphasis on the Pap and pelvic to well-woman care that assesses the whole woman,” said Jeanne A. Conry, MD, assistant physician-in-chief at the Permanente Medical Group in Roseville, Calif., and a past president of ACOG.

Ob.gyns. have long provided preventive care, but today more than ever before, Dr. Conry said, “my emphasis is on helping women to get well and stay well.”

The evolution

Fifty years ago, in 1966, use of the Pap test was being widely promoted, modern mammography techniques were on the cusp of advancement, and ob.gyns. were prescribing the first birth control pill approved by the Food and Drug Administration. ACOG’s main practice guidance book, “Standards for Obstetric-Gynecologic Hospital Services,” addressed the general physical examination but otherwise focused on obstetrics and reproductive health.

Thirty years later, women’s health care as described in the first edition of ACOG’s “Guidelines for Women’s Health Care” (1996) had grown to include distinct categories of “primary and preventive care” and “evaluation and counseling” that were separate from gynecologic services and broken down by age.

What was referred to as the “women’s health exam” through the 1990s gradually took on the “well-woman” label in the 2000s. Ob.gyns. were encouraged to address a growing range of preventive issues, but the annual Pap test remained a focus and, in many ways, drove women’s visits.

“Women would say, ‘I’m going for my Pap,’” Dr. Conry said.

Most recently, new technology and evidence-based reviews have changed the framework for well-woman visits to one with longer intervals for cervical cancer screening (every 3-5 years) and a move away from performing internal pelvic exams in all women (ACOG recommends pelvic exams annually for patients aged 21 and older but advises shared decision making for complete pelvic exams in asymptomatic patients).

Recent evidence reviews have also added some uncertainty about the role of annual breast exams in all women, as well as the role of breast self-exams, particularly for women not at high risk.

Maintaining patient relationships

One of the biggest and most immediate challenges for ob.gyns in the face of changing guidelines lies in maintaining the physician-patient relationship and “continuing communication” about the importance of regular well-woman visits, said Jill Rabin, MD, cochief of the division of ambulatory care, women’s health programs–prenatal care assistance program services at Northwell Health, New Hyde Park, N.Y.

“We want patients to understand that, even though they no longer need the Pap every year, they still should see us for good, comprehensive care ... that we can help them achieve their health care goals,” she said.

How often well-woman visits should occur has been a subject of much discussion. The HRSA-supported preventive services guidelines call for well-woman preventive care annually but note that “several visits may be needed to obtain all the necessary recommended services.”

And, in its first set of draft recommendations for HRSA, WPSI offered clarifications, saying there’s a need for “at least one annual preventive care visit for women beginning in adolescence and continuing across the lifespan to ensure that women obtain recommended preventive services” as determined by age and risk factors.

The draft recommendations, aimed at reviewing and updating the 2011 HRSA-sponsored guidelines, will be finalized by the end of 2016. WPSI will submit additional recommendations over the next 4 years.

Carol S. Weisman, PhD, a sociologist and health services researcher who sat on the Institute of Medicine committee that wrote the Women’s Preventive Services Guidelines, said the IOM’s recommendation for well-women visits – “in plural” form – recognizes “that historically many women have patched together their well-woman care from multiple providers, getting some of their preventive care from their generalist, and some from their ob.gyn.”

What’s more, the current list of preventive services covered under the Affordable Care Act is “enormous” – too long to address in one visit for many patients, said Dr. Weisman of the Penn State Center for Women’s Health Research in Hershey.

In addition to the women’s preventive services, the Affordable Care Act requires plans to cover services recommended with a grade A or B rating by the U.S. Preventive Services Task Force (counseling and screening for cancer, cardiovascular disease, and more) as well as vaccines recommended by the Advisory Committee on Immunization Practices, and HRSA’s Bright Futures services (for adolescents as well as children).

Beyond gynecology

How much further ob.gyns. will reach outside the gynecologic realm to offer additional preventive care services is an open question, but it’s likely to be based mainly on comfort levels, sources said.

“The changing needs of the gynecologic visit enable us to spend more time on other things,” said Hal C. Lawrence III, MD, ACOG’s executive vice president and chief executive officer. “But within the specialty, there’s going to be variation as to what level of expanded services ob.gyns. provide. Some will provide a lot of what women need, others not as much.”

Heather Johnson, MD, practices with a large ob.gyn. group in Chevy Chase, Md. and provides well-woman care largely to women in their 50s and 60s, whose children she delivered. She’s comfortable, she said, with screening for and treating osteoporosis and mild depression, for instance. She regularly performs lipid testing but refers out for management of high cholesterol levels or high blood pressure.

“I encourage all my patients to have a primary care physician of record,” she said, “but I still am happy to discuss the issues with them.”

What’s key, according to Dr. Lawrence and Dr. Conry, is coordination.

“We know there will be different individuals providing different components [of well-woman care],” Dr. Conry said. “I may see a woman for various things. Then she may go to her internist. But we should be able to collaborate to hit all the preventive health goals for her.”

Dr. Conry emphasized that the ob.gyn.’s expertise in reproductive health is critical to well-woman care planning, especially given medicine’s growing knowledge of how obstetric health and pregnancy complications can have long-term impacts on cardiovascular disease and other conditions. “It’s important for all providers to realize this,” she said.

Primary care status?

Intertwined with the future of well-women care is the issue of primary care status for ob.gyns. ACOG continues to advocate for ob.gyns. to be listed as primary care providers and part of primary care payment policies. Leaders are also pushing for projects on ob.gyn.–led medical homes.

At the same time, ACOG has been taking a broad collaborative approach to shaping well-woman care, aiming to develop comprehensive, age-specific recommendations for use by any provider who cares for adolescent girls and women.

Representatives of the American Academy of Family Physicians, the American College of Physicians, and the National Association of Nurse Practitioners in Women’s Health were involved in a Well-Woman Task Force that Dr. Conry appointed while serving as ACOG president in 2013-2014. These organizations now sit on WPSI’s advisory panel with ACOG.

Representatives from the American Academy of Pediatrics have also been close partners, as ACOG officials view the HRSA-sponsored Bright Futures guidelines (which includes the “Periodicity Schedule”) as a potential model for well-woman care. The guidelines are comprehensive, well-organized, and user-friendly, ACOG officials said.

At the University of Virginia, in the meantime, Dr. Peterson is arming the next generation of ob.gyns. with the skills needed for a team-based approach to well-woman visits. She said nurse practitioners and physician assistants will provide much more of the education and “more of the truly individualized conversations with patients” that will increasingly be part of well-woman care.

This is already happening. All of the nurse practitioners in Dr. Johnson’s group practice perform well-woman visits, “referring to the gynecologists for complicated gyn problems and out to the patient’s primary care physician for complicated medical problems,” Dr. Johnson said.

Even as the tools and recommendations for women’s preventive care become more evidence-based, the scope of well-woman visits will be based on risk factors, shared decision making, and other issues, Dr. Peterson said. “We will be telling patients, this is your path for your well-woman care,” she said.

Throughout 2016, Ob.Gyn. News is celebrating its 50th anniversary with exclusive articles looking at the evolution of the specialty, including the history of contraception, changes in gynecologic surgery, and whether the practice environment is better or worse.

From her vantage point in medical education, Christine M. Peterson, MD, is acutely aware that well-woman care is at a turning point.

“We’re at an interesting crossroads between tradition and evidence-based practice,” said Dr. Peterson, who practiced obstetrics and gynecology in the 1980s and now serves as associate professor of ob.gyn. and assistant dean for student affairs at the University of Virginia’s School of Medicine in Charlottesville.

Courtesy Bill Tolley/ University of Virginia

“Even young trainees are aware of the traditions for the annual well-woman visit – the Pap, the pelvic, the breast exam,” she said. “But the evidence is pointing us in a different direction ... toward doing only those things that are effective for prevention and early detection of disease, or that have [demonstrated] value in one way or another.”

If all goes as planned at a national level, Dr. Peterson’s students who become ob.gyns., family physicians, and general internists will practice under a reshaped and well-defined umbrella of well-woman care – one that includes a broad array of insurer-covered screening and counseling services.

That umbrella already includes HPV testing, and screening and/or counseling on intimate partner violence, sexually transmitted infections, and HIV, in addition to contraception counseling. These preventive services were described in the Women’s Preventive Services Guidelines and adopted as covered benefits by the Department of Health & Human Services in 2011.

And more change is on the way. In March, the American College of Obstetricians and Gynecologists (ACOG) launched the Women’s Preventive Services Initiative (WPSI) – a broad coalition tasked with recommending updates to the 2011 guidelines and developing new recommendations for the scope and implementation of women’s preventive health care services.

The effort is funded through a 5-year cooperative agreement with the Health Resources & Services Administration (HRSA). It’s similar to the American Academy of Pediatrics’ approach in developing the HRSA-supported Bright Futures guidelines almost 25 years ago. Under the Affordable Care Act, all HRSA-recommended preventive services must be covered by most private insurers without patient cost sharing.

Courtesy Carmen Martinez/ Kaiser Permanente

“Over the years, we’ve gone from an emphasis on the Pap and pelvic to well-woman care that assesses the whole woman,” said Jeanne A. Conry, MD, assistant physician-in-chief at the Permanente Medical Group in Roseville, Calif., and a past president of ACOG.

Ob.gyns. have long provided preventive care, but today more than ever before, Dr. Conry said, “my emphasis is on helping women to get well and stay well.”

The evolution

Fifty years ago, in 1966, use of the Pap test was being widely promoted, modern mammography techniques were on the cusp of advancement, and ob.gyns. were prescribing the first birth control pill approved by the Food and Drug Administration. ACOG’s main practice guidance book, “Standards for Obstetric-Gynecologic Hospital Services,” addressed the general physical examination but otherwise focused on obstetrics and reproductive health.

Thirty years later, women’s health care as described in the first edition of ACOG’s “Guidelines for Women’s Health Care” (1996) had grown to include distinct categories of “primary and preventive care” and “evaluation and counseling” that were separate from gynecologic services and broken down by age.

What was referred to as the “women’s health exam” through the 1990s gradually took on the “well-woman” label in the 2000s. Ob.gyns. were encouraged to address a growing range of preventive issues, but the annual Pap test remained a focus and, in many ways, drove women’s visits.

“Women would say, ‘I’m going for my Pap,’” Dr. Conry said.

Most recently, new technology and evidence-based reviews have changed the framework for well-woman visits to one with longer intervals for cervical cancer screening (every 3-5 years) and a move away from performing internal pelvic exams in all women (ACOG recommends pelvic exams annually for patients aged 21 and older but advises shared decision making for complete pelvic exams in asymptomatic patients).

Recent evidence reviews have also added some uncertainty about the role of annual breast exams in all women, as well as the role of breast self-exams, particularly for women not at high risk.

Maintaining patient relationships

One of the biggest and most immediate challenges for ob.gyns in the face of changing guidelines lies in maintaining the physician-patient relationship and “continuing communication” about the importance of regular well-woman visits, said Jill Rabin, MD, cochief of the division of ambulatory care, women’s health programs–prenatal care assistance program services at Northwell Health, New Hyde Park, N.Y.

“We want patients to understand that, even though they no longer need the Pap every year, they still should see us for good, comprehensive care ... that we can help them achieve their health care goals,” she said.

How often well-woman visits should occur has been a subject of much discussion. The HRSA-supported preventive services guidelines call for well-woman preventive care annually but note that “several visits may be needed to obtain all the necessary recommended services.”

And, in its first set of draft recommendations for HRSA, WPSI offered clarifications, saying there’s a need for “at least one annual preventive care visit for women beginning in adolescence and continuing across the lifespan to ensure that women obtain recommended preventive services” as determined by age and risk factors.

The draft recommendations, aimed at reviewing and updating the 2011 HRSA-sponsored guidelines, will be finalized by the end of 2016. WPSI will submit additional recommendations over the next 4 years.

Carol S. Weisman, PhD, a sociologist and health services researcher who sat on the Institute of Medicine committee that wrote the Women’s Preventive Services Guidelines, said the IOM’s recommendation for well-women visits – “in plural” form – recognizes “that historically many women have patched together their well-woman care from multiple providers, getting some of their preventive care from their generalist, and some from their ob.gyn.”

What’s more, the current list of preventive services covered under the Affordable Care Act is “enormous” – too long to address in one visit for many patients, said Dr. Weisman of the Penn State Center for Women’s Health Research in Hershey.

In addition to the women’s preventive services, the Affordable Care Act requires plans to cover services recommended with a grade A or B rating by the U.S. Preventive Services Task Force (counseling and screening for cancer, cardiovascular disease, and more) as well as vaccines recommended by the Advisory Committee on Immunization Practices, and HRSA’s Bright Futures services (for adolescents as well as children).

Beyond gynecology

How much further ob.gyns. will reach outside the gynecologic realm to offer additional preventive care services is an open question, but it’s likely to be based mainly on comfort levels, sources said.

“The changing needs of the gynecologic visit enable us to spend more time on other things,” said Hal C. Lawrence III, MD, ACOG’s executive vice president and chief executive officer. “But within the specialty, there’s going to be variation as to what level of expanded services ob.gyns. provide. Some will provide a lot of what women need, others not as much.”

Heather Johnson, MD, practices with a large ob.gyn. group in Chevy Chase, Md. and provides well-woman care largely to women in their 50s and 60s, whose children she delivered. She’s comfortable, she said, with screening for and treating osteoporosis and mild depression, for instance. She regularly performs lipid testing but refers out for management of high cholesterol levels or high blood pressure.

“I encourage all my patients to have a primary care physician of record,” she said, “but I still am happy to discuss the issues with them.”

What’s key, according to Dr. Lawrence and Dr. Conry, is coordination.

“We know there will be different individuals providing different components [of well-woman care],” Dr. Conry said. “I may see a woman for various things. Then she may go to her internist. But we should be able to collaborate to hit all the preventive health goals for her.”

Dr. Conry emphasized that the ob.gyn.’s expertise in reproductive health is critical to well-woman care planning, especially given medicine’s growing knowledge of how obstetric health and pregnancy complications can have long-term impacts on cardiovascular disease and other conditions. “It’s important for all providers to realize this,” she said.

Primary care status?

Intertwined with the future of well-women care is the issue of primary care status for ob.gyns. ACOG continues to advocate for ob.gyns. to be listed as primary care providers and part of primary care payment policies. Leaders are also pushing for projects on ob.gyn.–led medical homes.

At the same time, ACOG has been taking a broad collaborative approach to shaping well-woman care, aiming to develop comprehensive, age-specific recommendations for use by any provider who cares for adolescent girls and women.

Representatives of the American Academy of Family Physicians, the American College of Physicians, and the National Association of Nurse Practitioners in Women’s Health were involved in a Well-Woman Task Force that Dr. Conry appointed while serving as ACOG president in 2013-2014. These organizations now sit on WPSI’s advisory panel with ACOG.

Representatives from the American Academy of Pediatrics have also been close partners, as ACOG officials view the HRSA-sponsored Bright Futures guidelines (which includes the “Periodicity Schedule”) as a potential model for well-woman care. The guidelines are comprehensive, well-organized, and user-friendly, ACOG officials said.

At the University of Virginia, in the meantime, Dr. Peterson is arming the next generation of ob.gyns. with the skills needed for a team-based approach to well-woman visits. She said nurse practitioners and physician assistants will provide much more of the education and “more of the truly individualized conversations with patients” that will increasingly be part of well-woman care.

This is already happening. All of the nurse practitioners in Dr. Johnson’s group practice perform well-woman visits, “referring to the gynecologists for complicated gyn problems and out to the patient’s primary care physician for complicated medical problems,” Dr. Johnson said.

Even as the tools and recommendations for women’s preventive care become more evidence-based, the scope of well-woman visits will be based on risk factors, shared decision making, and other issues, Dr. Peterson said. “We will be telling patients, this is your path for your well-woman care,” she said.

Throughout 2016, Ob.Gyn. News is celebrating its 50th anniversary with exclusive articles looking at the evolution of the specialty, including the history of contraception, changes in gynecologic surgery, and whether the practice environment is better or worse.

From her vantage point in medical education, Christine M. Peterson, MD, is acutely aware that well-woman care is at a turning point.

“We’re at an interesting crossroads between tradition and evidence-based practice,” said Dr. Peterson, who practiced obstetrics and gynecology in the 1980s and now serves as associate professor of ob.gyn. and assistant dean for student affairs at the University of Virginia’s School of Medicine in Charlottesville.

Courtesy Bill Tolley/ University of Virginia

“Even young trainees are aware of the traditions for the annual well-woman visit – the Pap, the pelvic, the breast exam,” she said. “But the evidence is pointing us in a different direction ... toward doing only those things that are effective for prevention and early detection of disease, or that have [demonstrated] value in one way or another.”

If all goes as planned at a national level, Dr. Peterson’s students who become ob.gyns., family physicians, and general internists will practice under a reshaped and well-defined umbrella of well-woman care – one that includes a broad array of insurer-covered screening and counseling services.

That umbrella already includes HPV testing, and screening and/or counseling on intimate partner violence, sexually transmitted infections, and HIV, in addition to contraception counseling. These preventive services were described in the Women’s Preventive Services Guidelines and adopted as covered benefits by the Department of Health & Human Services in 2011.

And more change is on the way. In March, the American College of Obstetricians and Gynecologists (ACOG) launched the Women’s Preventive Services Initiative (WPSI) – a broad coalition tasked with recommending updates to the 2011 guidelines and developing new recommendations for the scope and implementation of women’s preventive health care services.

The effort is funded through a 5-year cooperative agreement with the Health Resources & Services Administration (HRSA). It’s similar to the American Academy of Pediatrics’ approach in developing the HRSA-supported Bright Futures guidelines almost 25 years ago. Under the Affordable Care Act, all HRSA-recommended preventive services must be covered by most private insurers without patient cost sharing.

Courtesy Carmen Martinez/ Kaiser Permanente

“Over the years, we’ve gone from an emphasis on the Pap and pelvic to well-woman care that assesses the whole woman,” said Jeanne A. Conry, MD, assistant physician-in-chief at the Permanente Medical Group in Roseville, Calif., and a past president of ACOG.

Ob.gyns. have long provided preventive care, but today more than ever before, Dr. Conry said, “my emphasis is on helping women to get well and stay well.”

The evolution

Fifty years ago, in 1966, use of the Pap test was being widely promoted, modern mammography techniques were on the cusp of advancement, and ob.gyns. were prescribing the first birth control pill approved by the Food and Drug Administration. ACOG’s main practice guidance book, “Standards for Obstetric-Gynecologic Hospital Services,” addressed the general physical examination but otherwise focused on obstetrics and reproductive health.

Thirty years later, women’s health care as described in the first edition of ACOG’s “Guidelines for Women’s Health Care” (1996) had grown to include distinct categories of “primary and preventive care” and “evaluation and counseling” that were separate from gynecologic services and broken down by age.

What was referred to as the “women’s health exam” through the 1990s gradually took on the “well-woman” label in the 2000s. Ob.gyns. were encouraged to address a growing range of preventive issues, but the annual Pap test remained a focus and, in many ways, drove women’s visits.

“Women would say, ‘I’m going for my Pap,’” Dr. Conry said.

Most recently, new technology and evidence-based reviews have changed the framework for well-woman visits to one with longer intervals for cervical cancer screening (every 3-5 years) and a move away from performing internal pelvic exams in all women (ACOG recommends pelvic exams annually for patients aged 21 and older but advises shared decision making for complete pelvic exams in asymptomatic patients).

Recent evidence reviews have also added some uncertainty about the role of annual breast exams in all women, as well as the role of breast self-exams, particularly for women not at high risk.

Maintaining patient relationships

One of the biggest and most immediate challenges for ob.gyns in the face of changing guidelines lies in maintaining the physician-patient relationship and “continuing communication” about the importance of regular well-woman visits, said Jill Rabin, MD, cochief of the division of ambulatory care, women’s health programs–prenatal care assistance program services at Northwell Health, New Hyde Park, N.Y.

“We want patients to understand that, even though they no longer need the Pap every year, they still should see us for good, comprehensive care ... that we can help them achieve their health care goals,” she said.

How often well-woman visits should occur has been a subject of much discussion. The HRSA-supported preventive services guidelines call for well-woman preventive care annually but note that “several visits may be needed to obtain all the necessary recommended services.”

And, in its first set of draft recommendations for HRSA, WPSI offered clarifications, saying there’s a need for “at least one annual preventive care visit for women beginning in adolescence and continuing across the lifespan to ensure that women obtain recommended preventive services” as determined by age and risk factors.

The draft recommendations, aimed at reviewing and updating the 2011 HRSA-sponsored guidelines, will be finalized by the end of 2016. WPSI will submit additional recommendations over the next 4 years.

Carol S. Weisman, PhD, a sociologist and health services researcher who sat on the Institute of Medicine committee that wrote the Women’s Preventive Services Guidelines, said the IOM’s recommendation for well-women visits – “in plural” form – recognizes “that historically many women have patched together their well-woman care from multiple providers, getting some of their preventive care from their generalist, and some from their ob.gyn.”

What’s more, the current list of preventive services covered under the Affordable Care Act is “enormous” – too long to address in one visit for many patients, said Dr. Weisman of the Penn State Center for Women’s Health Research in Hershey.

In addition to the women’s preventive services, the Affordable Care Act requires plans to cover services recommended with a grade A or B rating by the U.S. Preventive Services Task Force (counseling and screening for cancer, cardiovascular disease, and more) as well as vaccines recommended by the Advisory Committee on Immunization Practices, and HRSA’s Bright Futures services (for adolescents as well as children).

Beyond gynecology

How much further ob.gyns. will reach outside the gynecologic realm to offer additional preventive care services is an open question, but it’s likely to be based mainly on comfort levels, sources said.

“The changing needs of the gynecologic visit enable us to spend more time on other things,” said Hal C. Lawrence III, MD, ACOG’s executive vice president and chief executive officer. “But within the specialty, there’s going to be variation as to what level of expanded services ob.gyns. provide. Some will provide a lot of what women need, others not as much.”

Heather Johnson, MD, practices with a large ob.gyn. group in Chevy Chase, Md. and provides well-woman care largely to women in their 50s and 60s, whose children she delivered. She’s comfortable, she said, with screening for and treating osteoporosis and mild depression, for instance. She regularly performs lipid testing but refers out for management of high cholesterol levels or high blood pressure.

“I encourage all my patients to have a primary care physician of record,” she said, “but I still am happy to discuss the issues with them.”

What’s key, according to Dr. Lawrence and Dr. Conry, is coordination.

“We know there will be different individuals providing different components [of well-woman care],” Dr. Conry said. “I may see a woman for various things. Then she may go to her internist. But we should be able to collaborate to hit all the preventive health goals for her.”

Dr. Conry emphasized that the ob.gyn.’s expertise in reproductive health is critical to well-woman care planning, especially given medicine’s growing knowledge of how obstetric health and pregnancy complications can have long-term impacts on cardiovascular disease and other conditions. “It’s important for all providers to realize this,” she said.

Primary care status?

Intertwined with the future of well-women care is the issue of primary care status for ob.gyns. ACOG continues to advocate for ob.gyns. to be listed as primary care providers and part of primary care payment policies. Leaders are also pushing for projects on ob.gyn.–led medical homes.

At the same time, ACOG has been taking a broad collaborative approach to shaping well-woman care, aiming to develop comprehensive, age-specific recommendations for use by any provider who cares for adolescent girls and women.

Representatives of the American Academy of Family Physicians, the American College of Physicians, and the National Association of Nurse Practitioners in Women’s Health were involved in a Well-Woman Task Force that Dr. Conry appointed while serving as ACOG president in 2013-2014. These organizations now sit on WPSI’s advisory panel with ACOG.

Representatives from the American Academy of Pediatrics have also been close partners, as ACOG officials view the HRSA-sponsored Bright Futures guidelines (which includes the “Periodicity Schedule”) as a potential model for well-woman care. The guidelines are comprehensive, well-organized, and user-friendly, ACOG officials said.

At the University of Virginia, in the meantime, Dr. Peterson is arming the next generation of ob.gyns. with the skills needed for a team-based approach to well-woman visits. She said nurse practitioners and physician assistants will provide much more of the education and “more of the truly individualized conversations with patients” that will increasingly be part of well-woman care.

This is already happening. All of the nurse practitioners in Dr. Johnson’s group practice perform well-woman visits, “referring to the gynecologists for complicated gyn problems and out to the patient’s primary care physician for complicated medical problems,” Dr. Johnson said.

Even as the tools and recommendations for women’s preventive care become more evidence-based, the scope of well-woman visits will be based on risk factors, shared decision making, and other issues, Dr. Peterson said. “We will be telling patients, this is your path for your well-woman care,” she said.

Throughout 2016, Ob.Gyn. News is celebrating its 50th anniversary with exclusive articles looking at the evolution of the specialty, including the history of contraception, changes in gynecologic surgery, and whether the practice environment is better or worse.

The U.S. has more motor vehicle crash deaths than do other high-income countries. Iin fact, the rate in the U.S. is roughly double the nearest countries in line: 10 deaths per 100,000 people, vs 5 to 6 in New Zealand, Canada, and France.

About one-third of deaths are due to drunk driving, and speeding contributes to another third. More than 9,500 of the deaths were due to passengers not using seat belts, car seats, or booster seats. Seat belts saved 12,500 plus lives in 2013, the CDC says, but about half of drivers or passengers who died in crashes weren’t buckled up. By contrast, 99% of drivers and passengers use front seat belts in France, and the average of the 19 countries studied is 94%—vs 87% in the U.S.

Although U.S. crash deaths fell 31% between 2000 and 2013, losing 90 people a day to crashes is still far too high, says the CDC. According to a Vital Signs report, more than 18,000 of the 32,000 lives lost each year could be saved if the U.S. took some safety tips from the other countries, the report says. Enforcing seat belt laws that cover everyone in every seat would be a good step, for instance. As would redefining blood alcohol concentration (BAC) limits—all the comparison countries use BAC levels at 0.02% to 0.05%, vs 0.08% in the U.S., Canada, and the United Kingdom. The report also urges using advanced engineering and technology, such as ignition interlocks for people convicted of drunk driving.

In the meantime, the CDC says, health care providers can help by reminding patients about using a seat belt on every trip, no matter how short; counseling parents on age- and size-appropriate seats for children; talking to patients about the dangers of impaired driving and “distracted” driving (eg, using cell phones or texting); and giving parents and caregivers of teens resources on safe teen driving.

The U.S. has more motor vehicle crash deaths than do other high-income countries. Iin fact, the rate in the U.S. is roughly double the nearest countries in line: 10 deaths per 100,000 people, vs 5 to 6 in New Zealand, Canada, and France.

About one-third of deaths are due to drunk driving, and speeding contributes to another third. More than 9,500 of the deaths were due to passengers not using seat belts, car seats, or booster seats. Seat belts saved 12,500 plus lives in 2013, the CDC says, but about half of drivers or passengers who died in crashes weren’t buckled up. By contrast, 99% of drivers and passengers use front seat belts in France, and the average of the 19 countries studied is 94%—vs 87% in the U.S.

Although U.S. crash deaths fell 31% between 2000 and 2013, losing 90 people a day to crashes is still far too high, says the CDC. According to a Vital Signs report, more than 18,000 of the 32,000 lives lost each year could be saved if the U.S. took some safety tips from the other countries, the report says. Enforcing seat belt laws that cover everyone in every seat would be a good step, for instance. As would redefining blood alcohol concentration (BAC) limits—all the comparison countries use BAC levels at 0.02% to 0.05%, vs 0.08% in the U.S., Canada, and the United Kingdom. The report also urges using advanced engineering and technology, such as ignition interlocks for people convicted of drunk driving.

In the meantime, the CDC says, health care providers can help by reminding patients about using a seat belt on every trip, no matter how short; counseling parents on age- and size-appropriate seats for children; talking to patients about the dangers of impaired driving and “distracted” driving (eg, using cell phones or texting); and giving parents and caregivers of teens resources on safe teen driving.

The U.S. has more motor vehicle crash deaths than do other high-income countries. Iin fact, the rate in the U.S. is roughly double the nearest countries in line: 10 deaths per 100,000 people, vs 5 to 6 in New Zealand, Canada, and France.

About one-third of deaths are due to drunk driving, and speeding contributes to another third. More than 9,500 of the deaths were due to passengers not using seat belts, car seats, or booster seats. Seat belts saved 12,500 plus lives in 2013, the CDC says, but about half of drivers or passengers who died in crashes weren’t buckled up. By contrast, 99% of drivers and passengers use front seat belts in France, and the average of the 19 countries studied is 94%—vs 87% in the U.S.

Although U.S. crash deaths fell 31% between 2000 and 2013, losing 90 people a day to crashes is still far too high, says the CDC. According to a Vital Signs report, more than 18,000 of the 32,000 lives lost each year could be saved if the U.S. took some safety tips from the other countries, the report says. Enforcing seat belt laws that cover everyone in every seat would be a good step, for instance. As would redefining blood alcohol concentration (BAC) limits—all the comparison countries use BAC levels at 0.02% to 0.05%, vs 0.08% in the U.S., Canada, and the United Kingdom. The report also urges using advanced engineering and technology, such as ignition interlocks for people convicted of drunk driving.

In the meantime, the CDC says, health care providers can help by reminding patients about using a seat belt on every trip, no matter how short; counseling parents on age- and size-appropriate seats for children; talking to patients about the dangers of impaired driving and “distracted” driving (eg, using cell phones or texting); and giving parents and caregivers of teens resources on safe teen driving.

More than half of all Americans have a cataract or have had cataract surgery by age 80. Almost 4 million cataract surgeries are performed each year.

The mainstay of treatment has been monofocal lenses that improve distance vision. However, the FDA has just approved the first intraocular lens (IOL) to provide extended depth-of-focus, which improves sharpness of vision at near, intermediate, and far distances.

The Tecnis Symfony Extended Range of Vision IOL has been available in Europe since 2014. At the 2014 American Academy of Ophthalmology meeting, US cataract surgeon Mark Packer, MD, called the new lens “an exciting development.”

The lens is designed to correct both chromatic aberration (inability to focus due to competing wavelengths of light passing through the lens at different angles) and spherical aberration (lack of focus due to the shape of the lens). Clinical studies have demonstrated a low incidence of dysphotopsias such as halo and glare, which can impede night vision and driving. However, the FDA cautions that some patients experience visual halos, glare, or starbursts; some may experience worsening of or blurred vision, bleeding, or infection; and the device may cause reduced contrast sensitivity that worsens under poor visibility conditions.

More than 50 countries have approved the IOL has been approved, and has been widely studied with data from clinical studies involving more than 2,000 eyes, according to the manufacturer, Abbott Laboratories. FDA approval was based on a review of results from a study comparing 148 cataract patients implanted with the Tecnis Symfony Extended Range of Vision IOL and 151 patients implanted with a monofocal IOL.

Both groups of patients had comparable results for good distance vision. Of the patients in the Tecnis Symfony group, 77% had good vision (20/25) without glasses at intermediate distance, compared with 34% of those in the monofocal group. At near distances, patients with the Tecnis Symfony IOL could read 2 additional, progressively smaller lines on a standard eye chart, compared with those in the monofocal group.

In clinical trials for Tecnis IOLs, adverse events occurred at rates between 1.6% and 3.3%, including macular edema, endophthalmitis, and anterior lens tissue ongrowth. However, the events were not related to the lenses, the manufacturer says.

The FDA approval includes a version of the lens for people with astigmatism. The new lens is available in 4 toric models.

More than half of all Americans have a cataract or have had cataract surgery by age 80. Almost 4 million cataract surgeries are performed each year.

The mainstay of treatment has been monofocal lenses that improve distance vision. However, the FDA has just approved the first intraocular lens (IOL) to provide extended depth-of-focus, which improves sharpness of vision at near, intermediate, and far distances.

The Tecnis Symfony Extended Range of Vision IOL has been available in Europe since 2014. At the 2014 American Academy of Ophthalmology meeting, US cataract surgeon Mark Packer, MD, called the new lens “an exciting development.”

The lens is designed to correct both chromatic aberration (inability to focus due to competing wavelengths of light passing through the lens at different angles) and spherical aberration (lack of focus due to the shape of the lens). Clinical studies have demonstrated a low incidence of dysphotopsias such as halo and glare, which can impede night vision and driving. However, the FDA cautions that some patients experience visual halos, glare, or starbursts; some may experience worsening of or blurred vision, bleeding, or infection; and the device may cause reduced contrast sensitivity that worsens under poor visibility conditions.

More than 50 countries have approved the IOL has been approved, and has been widely studied with data from clinical studies involving more than 2,000 eyes, according to the manufacturer, Abbott Laboratories. FDA approval was based on a review of results from a study comparing 148 cataract patients implanted with the Tecnis Symfony Extended Range of Vision IOL and 151 patients implanted with a monofocal IOL.

Both groups of patients had comparable results for good distance vision. Of the patients in the Tecnis Symfony group, 77% had good vision (20/25) without glasses at intermediate distance, compared with 34% of those in the monofocal group. At near distances, patients with the Tecnis Symfony IOL could read 2 additional, progressively smaller lines on a standard eye chart, compared with those in the monofocal group.

In clinical trials for Tecnis IOLs, adverse events occurred at rates between 1.6% and 3.3%, including macular edema, endophthalmitis, and anterior lens tissue ongrowth. However, the events were not related to the lenses, the manufacturer says.

The FDA approval includes a version of the lens for people with astigmatism. The new lens is available in 4 toric models.

More than half of all Americans have a cataract or have had cataract surgery by age 80. Almost 4 million cataract surgeries are performed each year.

The mainstay of treatment has been monofocal lenses that improve distance vision. However, the FDA has just approved the first intraocular lens (IOL) to provide extended depth-of-focus, which improves sharpness of vision at near, intermediate, and far distances.

The Tecnis Symfony Extended Range of Vision IOL has been available in Europe since 2014. At the 2014 American Academy of Ophthalmology meeting, US cataract surgeon Mark Packer, MD, called the new lens “an exciting development.”

The lens is designed to correct both chromatic aberration (inability to focus due to competing wavelengths of light passing through the lens at different angles) and spherical aberration (lack of focus due to the shape of the lens). Clinical studies have demonstrated a low incidence of dysphotopsias such as halo and glare, which can impede night vision and driving. However, the FDA cautions that some patients experience visual halos, glare, or starbursts; some may experience worsening of or blurred vision, bleeding, or infection; and the device may cause reduced contrast sensitivity that worsens under poor visibility conditions.

More than 50 countries have approved the IOL has been approved, and has been widely studied with data from clinical studies involving more than 2,000 eyes, according to the manufacturer, Abbott Laboratories. FDA approval was based on a review of results from a study comparing 148 cataract patients implanted with the Tecnis Symfony Extended Range of Vision IOL and 151 patients implanted with a monofocal IOL.

Both groups of patients had comparable results for good distance vision. Of the patients in the Tecnis Symfony group, 77% had good vision (20/25) without glasses at intermediate distance, compared with 34% of those in the monofocal group. At near distances, patients with the Tecnis Symfony IOL could read 2 additional, progressively smaller lines on a standard eye chart, compared with those in the monofocal group.

In clinical trials for Tecnis IOLs, adverse events occurred at rates between 1.6% and 3.3%, including macular edema, endophthalmitis, and anterior lens tissue ongrowth. However, the events were not related to the lenses, the manufacturer says.

The FDA approval includes a version of the lens for people with astigmatism. The new lens is available in 4 toric models.

Clinical Question: What are current recommendations for diagnosis, management, and prevention of acute gastrointestinal infection in immune-competent adults?

Background: Acute diarrheal infection is a leading cause of healthcare visits and lost quality of life. The Centers for Disease Control and Prevention estimates there are 47.8 million cases annually, with a healthcare economy burden of $150 million.

Study Design: American College of Gastroenterology (ACG) practice guideline.

Setting: Expert panel.

Synopsis: Stool diagnostic studies may be used for dysentery with moderate-severe disease and symptoms lasting more than seven days (strong recommendation, low level of evidence). Traditional diagnostic methods in most cases fail to reveal etiology (strong recommendation, low level of evidence). Treatment with probiotics or prebiotics is not recommended (strong recommendation, moderate level of evidence). Bismuth subsalicylates may be considered for prophylaxis against traveler’s diarrhea (strong recommendation, high level of evidence). Short-term antibiotic chemoprophylaxis also may be considered for high-risk groups (strong recommendation, high level of evidence). Empiric antimicrobial therapy is not recommended except in cases of traveler’s diarrhea (strong recommendation, high level of evidence). Loperamide may be used as an adjunct to antibiotics for traveler’s diarrhea (strong recommendation, moderate level of evidence).

Bottom Line: ACG acute diarrheal illness guidelines have been updated. Few recommendations are strong, and very few have high levels of evidence.

Citation: Riddle MS, DuPont HL, Conner BA. ACG clinical guideline: diagnosis, treatment, and prevention of acute diarrheal infections in adults. Am J Gastroenterol. 2016;111(5):602-622.

Clinical Question: What are current recommendations for diagnosis, management, and prevention of acute gastrointestinal infection in immune-competent adults?

Background: Acute diarrheal infection is a leading cause of healthcare visits and lost quality of life. The Centers for Disease Control and Prevention estimates there are 47.8 million cases annually, with a healthcare economy burden of $150 million.

Study Design: American College of Gastroenterology (ACG) practice guideline.

Setting: Expert panel.

Synopsis: Stool diagnostic studies may be used for dysentery with moderate-severe disease and symptoms lasting more than seven days (strong recommendation, low level of evidence). Traditional diagnostic methods in most cases fail to reveal etiology (strong recommendation, low level of evidence). Treatment with probiotics or prebiotics is not recommended (strong recommendation, moderate level of evidence). Bismuth subsalicylates may be considered for prophylaxis against traveler’s diarrhea (strong recommendation, high level of evidence). Short-term antibiotic chemoprophylaxis also may be considered for high-risk groups (strong recommendation, high level of evidence). Empiric antimicrobial therapy is not recommended except in cases of traveler’s diarrhea (strong recommendation, high level of evidence). Loperamide may be used as an adjunct to antibiotics for traveler’s diarrhea (strong recommendation, moderate level of evidence).

Bottom Line: ACG acute diarrheal illness guidelines have been updated. Few recommendations are strong, and very few have high levels of evidence.

Citation: Riddle MS, DuPont HL, Conner BA. ACG clinical guideline: diagnosis, treatment, and prevention of acute diarrheal infections in adults. Am J Gastroenterol. 2016;111(5):602-622.

Clinical Question: What are current recommendations for diagnosis, management, and prevention of acute gastrointestinal infection in immune-competent adults?

Background: Acute diarrheal infection is a leading cause of healthcare visits and lost quality of life. The Centers for Disease Control and Prevention estimates there are 47.8 million cases annually, with a healthcare economy burden of $150 million.

Study Design: American College of Gastroenterology (ACG) practice guideline.

Setting: Expert panel.

Synopsis: Stool diagnostic studies may be used for dysentery with moderate-severe disease and symptoms lasting more than seven days (strong recommendation, low level of evidence). Traditional diagnostic methods in most cases fail to reveal etiology (strong recommendation, low level of evidence). Treatment with probiotics or prebiotics is not recommended (strong recommendation, moderate level of evidence). Bismuth subsalicylates may be considered for prophylaxis against traveler’s diarrhea (strong recommendation, high level of evidence). Short-term antibiotic chemoprophylaxis also may be considered for high-risk groups (strong recommendation, high level of evidence). Empiric antimicrobial therapy is not recommended except in cases of traveler’s diarrhea (strong recommendation, high level of evidence). Loperamide may be used as an adjunct to antibiotics for traveler’s diarrhea (strong recommendation, moderate level of evidence).

Bottom Line: ACG acute diarrheal illness guidelines have been updated. Few recommendations are strong, and very few have high levels of evidence.

Citation: Riddle MS, DuPont HL, Conner BA. ACG clinical guideline: diagnosis, treatment, and prevention of acute diarrheal infections in adults. Am J Gastroenterol. 2016;111(5):602-622.

Clinical Question: Do risk-assessment models (RAMs) accurately predict which hospitalized medical patients are at risk for venous thromboembolism (VTE)?

Background: Predicting which patients are at high risk for VTE is important. Several models exist, but limited data support their generalizability and accuracy in medical inpatients.

Study Design: Retrospective cohort.

Setting: Hospitals participating in the Michigan Hospital Medicine Safety Consortium (MHMSC).

Synopsis: Data collected through MHMSC for selected medical patients were used in the Kucher, Padua, predictive IMPROVE, and Intermountain DVT risk-assessment models. Patients were classified as “low risk” or “at risk” based on each RAM. Follow-up data came from chart extraction (100% of patients) and 90-day post-discharge telephone calls (58% of patients). The primary outcome was image-confirmed hospital associated VTE, including proximal upper- or proximal lower-extremity DVT or pulmonary embolism. These RAMs classified less than 20% of patients as “at risk.” The incidence of VTE was less than 1%. In this external validation study, the Kucher RAM was the least discriminate and the Intermountain was the best, but none yielded results equivalent to the original studies.

This study was limited by the retrospective design, subjectivity of some risk factors (such as immobility), and inability to obtain 90-day telephone follow-up in all patients. Lastly, the binary approach (“at risk” versus “low risk”) may not align with the original derivation studies in which each factor was evaluated independently.

Bottom Line: The incidence of VTE is low in medical inpatients, and current RAMs may not accurately identify at-risk patients.

Citation: Greene MT, Spyropoulos AC, Chopra V, et al. Validation of risk assessment models of venous thromboembolism in hospitalized medical patients. Am J Med. 2016;129(9):1001.e9-1001.e18. doi:10.1016/j.amjmed.2016.03.031.

Clinical Question: Do risk-assessment models (RAMs) accurately predict which hospitalized medical patients are at risk for venous thromboembolism (VTE)?

Background: Predicting which patients are at high risk for VTE is important. Several models exist, but limited data support their generalizability and accuracy in medical inpatients.

Study Design: Retrospective cohort.

Setting: Hospitals participating in the Michigan Hospital Medicine Safety Consortium (MHMSC).

Synopsis: Data collected through MHMSC for selected medical patients were used in the Kucher, Padua, predictive IMPROVE, and Intermountain DVT risk-assessment models. Patients were classified as “low risk” or “at risk” based on each RAM. Follow-up data came from chart extraction (100% of patients) and 90-day post-discharge telephone calls (58% of patients). The primary outcome was image-confirmed hospital associated VTE, including proximal upper- or proximal lower-extremity DVT or pulmonary embolism. These RAMs classified less than 20% of patients as “at risk.” The incidence of VTE was less than 1%. In this external validation study, the Kucher RAM was the least discriminate and the Intermountain was the best, but none yielded results equivalent to the original studies.

This study was limited by the retrospective design, subjectivity of some risk factors (such as immobility), and inability to obtain 90-day telephone follow-up in all patients. Lastly, the binary approach (“at risk” versus “low risk”) may not align with the original derivation studies in which each factor was evaluated independently.

Bottom Line: The incidence of VTE is low in medical inpatients, and current RAMs may not accurately identify at-risk patients.

Citation: Greene MT, Spyropoulos AC, Chopra V, et al. Validation of risk assessment models of venous thromboembolism in hospitalized medical patients. Am J Med. 2016;129(9):1001.e9-1001.e18. doi:10.1016/j.amjmed.2016.03.031.

Clinical Question: Do risk-assessment models (RAMs) accurately predict which hospitalized medical patients are at risk for venous thromboembolism (VTE)?

Background: Predicting which patients are at high risk for VTE is important. Several models exist, but limited data support their generalizability and accuracy in medical inpatients.

Study Design: Retrospective cohort.

Setting: Hospitals participating in the Michigan Hospital Medicine Safety Consortium (MHMSC).

Synopsis: Data collected through MHMSC for selected medical patients were used in the Kucher, Padua, predictive IMPROVE, and Intermountain DVT risk-assessment models. Patients were classified as “low risk” or “at risk” based on each RAM. Follow-up data came from chart extraction (100% of patients) and 90-day post-discharge telephone calls (58% of patients). The primary outcome was image-confirmed hospital associated VTE, including proximal upper- or proximal lower-extremity DVT or pulmonary embolism. These RAMs classified less than 20% of patients as “at risk.” The incidence of VTE was less than 1%. In this external validation study, the Kucher RAM was the least discriminate and the Intermountain was the best, but none yielded results equivalent to the original studies.

This study was limited by the retrospective design, subjectivity of some risk factors (such as immobility), and inability to obtain 90-day telephone follow-up in all patients. Lastly, the binary approach (“at risk” versus “low risk”) may not align with the original derivation studies in which each factor was evaluated independently.

Bottom Line: The incidence of VTE is low in medical inpatients, and current RAMs may not accurately identify at-risk patients.

Citation: Greene MT, Spyropoulos AC, Chopra V, et al. Validation of risk assessment models of venous thromboembolism in hospitalized medical patients. Am J Med. 2016;129(9):1001.e9-1001.e18. doi:10.1016/j.amjmed.2016.03.031.

Complementary and alternative medicine (CAM) are health and wellness practices that are outside conventional allopathic medicine. In the U.S., the popularity of CAM has grown, and patients often use CAM to treat pain, insomnia, anxiety, and depression.^1-5 Veterans also have been increasingly adding CAM to conventional medicine, although limited studies exist on veteran use and attitudes toward CAM.^6-8

Recently, the VA has increased its CAM services, offering different treatments at various VA facilities where CAM is most commonly used to treat anxiety, posttraumatic stress disorder (PTSD), depression, and back pain.⁹ Some veterans also seek CAM services outside the VA.^6,8 Across studies of veterans and the broader population, having more years of education and higher income and being middle-aged, female, and white were associated with greater CAM use.^1,3,6-8

Some CAM practices, such as acupuncture, require a practitioner’s regular and direct involvement. Other, independent CAM practices can be taught in classes, individual sessions, or through self-instructional multimedia. Once learned, these practices can be done independently, allowing for easier and less costly access. Independent CAM practices, such as yoga, meditation, breathing exercises, qigong, and tai chi promote general wellness or treat a particular ailment.

Although results have been mixed, several studies support independent CAM practices for treatment and symptom relief. For example, yoga improves symptoms in neurologic and psychiatric disorders, lessens pain, and helps decrease anxiety and depression and improve self-efficacy.^10-13 Qigong can improve hypertensionand self-efficacy.^14,15

This study examines veterans’ attitudes and beliefs about CAM, which can affect their interest and use of CAM services within and outside the VA. The focus is exclusively on independent CAM practices. At the time of the study, the availability of more direct CAM practices, such as acupuncture, was limited at many VA sites, and independently practiced techniques often require fewer resources and, therefore, could be adapted more easily. Subsequent references to CAM in this study refer only to independent CAM practices.

The current study surveyed veterans in New Jersey in multiple VA clinics and non-VA peer-counseling settings as part of an implementation study of a veteran-centric DVD called the STAR (Simple Tools to Aid and Restore) Well-Kit (SWK), which serves as a veteran introduction to CAM.¹⁶ Before watching the DVD, veterans were asked to fill out a baseline survey about their knowledge, attitudes, beliefs, and experiences with CAM as well as answer screening and demographic questions.

The authors describe the findings of the baseline survey to inform how to best implement CAM more broadly throughout VA. They expected that knowledge, attitudes, beliefs, and experiences with CAM would vary by clinical setting and respondent characteristics and hypothesized that psychological factors would be related to interest in CAM. Finally, barriers and facilitators of use of CAM are reported to inform policies to promote veteran access to CAM.

Methods

This cross-sectional analysis of the baseline SWK surveys had no inclusion or exclusion criteria because participation was anonymous. Recipients received a packet that instructed them to complete a previewing survey, watch the DVD, and complete a postviewing survey about the DVD. Surveys were returned in person or by postage-paid envelopes. No follow-up reminders were provided. This study examines data from only the previewing survey, and all further references to the veteran presurvey refers to it as the survey.

Study sites were the outpatient services of the VA New Jersey Health Care System (VANJHCS) and a non-VHA New Jersey veteran peer-counseling office. VANJHCS, which enrolls patients from northern and central New Jersey, offers health care services at 2 campuses and 9 outpatient clinics. Waivers of informed consent were approved by the VANJHCS Institutional Review Board and Research and Development Committee given the anonymous and low-risk nature of the research.

Participant Recruitment

The survey was distributed at 4 settings selected with a focus on ambulatory services and a goal of ensuring participant diversity in age, deployment experience, and mental and physical health conditions. At 3 settings, surveys were distributed using 3 methods: by a researcher; left for pickup in waiting rooms; or by selected health care providers at their discretion in the context of routine clinical visits. The VANJHCS settings were outpatient mental-health clinics, outpatient primary-care settings, and outpatient transition-unit clinics for recent combat veterans. The fourth setting was a community veteran peer-support organization staffed by veterans and included events held at the organization’s offices, veteran informational and health fairs in the community, and outreach events at college campuses. In this setting, veteran peers distributed the SWK at their discretion; they were given suggested talking points for distribution.

Survey Data Collection

Veterans filled out baseline surveys before viewing the SWK DVD. The surveys were anonymous but coded with a number to allow for tracking by setting and dissemination method. The surveys asked for demographic and health information and experience with and interest in CAM techniques. To minimize respondent burden, the authors focused on the most critical domains as summarized in the background section (demographics; health status and symptoms, including pain; self-efficacy; mental health conditions; knowledge, attitudes, and beliefs about CAM).

Demographic Information

Age range was assessed to avoid collecting identifying information. The questionnaire also included gender, military era/deployment, employment status, and race and ethnicity.

• Self-Rated Health (SF1). Self-rated health was assessed with a widely used single-item question that correlates highly with actual overall health and with function and quality of life.^17,18 Respondents were asked to rate their health as excellent (5), very good, good, fair, or poor (1).
•  Pain Screen (PEG 3-item scale). This 3-item screen has shown reliability and validity and is comparable to longer pain questionnaires.¹⁹ Respondents were asked to rate 3 measures of their pain and its consequences on a scale of 0 (no pain or no interference from pain) to 10 (worst pain or interference). Responses were averaged to determine pain score.
•  PTSD Screen. This 4-item PTSD screen was developed for primary care and is widely used in VA settings.²⁰ For each item, respondents were asked to check off whether they have had specific PTSD symptoms within the past month. The screen was considered positive with 3 of 4 affirmative responses.
•  Anxiety and Depression Screen (PHQ-4). This 4-item scale combines the brief 2-item scales for screening anxiety and depression in primary care.²¹ For each depression or anxiety symptom, respondents selected from “not at all,” (1) “several days ”(2), “more days than not,” (3) and “nearly every day.” (4) For each 2-item screen, a sum of 5 or more indicated a positive screen.
• Self-Efficacy for Health Management (modified). The original 6-item self-efficacy screen was developed to test self-efficacy in managing chronic disease.²² Since not all participants in the current study were expected to have a chronic disease, the questions were modified to address more general self-efficacy for health management. Although the scale had not been adapted in this way or validated with this change, other authors have similarly adapted it to address specific chronic diseases with satisfactory results.^23,24 For each item, respondents were asked to rate their confidence in their ability to manage aspects of their health on a scale of 1 (not at all confident) to 10 (very confident). Participants could also check “not applicable” for items that did not apply to their health concerns, and these items were not counted in the average score.
•  Familiarity With and Interest in CAM. The authors developed a checklist to assess whether participants had heard of, tried, or were practicing the 4 CAM techniques featured in the SWK and to gauge their interest in learning about them (ie, meditation/guided imagery, breathing exercises, yoga, tai chi or qigong). For each technique, respondents selected that they have “never heard of,” “heard of but never tried,” “have done this in the past,” or “are currently doing.” For some analyses, the first 2 and last 2 options were combined to determine whether respondents had done each practice. They were also asked to check off whether they would like to learn more about the practice and whether they would like to try it with an instructor and/or try it on their own. For some analyses, each technique was looked at separately, whereas for others, the 4 techniques were combined to determine whether they had tried or were currently doing any of them.
• Barriers to Practice. The authors developed a checklist of 10 barriers to practicing CAM techniques based on research but with adjustments to the specific practices and population under investigation.²⁵ The checklist included an open-end response to allow respondents to add barriers. The barrier list was a checklist and not a validated scale.
•  Perceived Benefits of CAM. The authors developed 2 questions to assess the perceived benefits of these techniques on functionality and overall wellness, rated on a Likert scale from 1 (no benefits) to 10 (very much).

Statistical Analysis

Survey instruments were scored according to generally accepted and published practices. Item-level analysis was performed to identify missing responses and describe the sample. Summary statistics were reported. Pearson product moment correlation was used to detect associations between continuous variables. Analysis of variance (ANOVA) was used to detect associations between dichotomous and continuous variables. Chi-square tests were used to detect associations between categorical variables, specifically looking at clinically meaningful differences between veterans who had experience with or interest in trying independent CAM practices and those who did not. Linear regression analysis was used to determine significant associations between participant characteristics and the belief that independent CAM practices would be helpful with daily function.

Results

The response rate for returning surveys was low (n = 134; 18.2%). Surveys distributed by peers in the community setting had the highest response rate (38%), followed by surveys distributed in primary care (23%).

Due to the anonymous nature of the survey, information on nonresponder characteristics was not available. Respondents covered a range of ages, with 64% of respondents aged ≥ 50 years. Respondents were men (88%) and white (49%) or African American (40%). Fifty-five percent screened positive for at least 1 mental health condition (PTSD, depression, or anxiety). The average self-rated health was 2.9 on a scale of 1 (poor health) to 5 (excellent health). Gender, age range, race, and deployment status were comparable with New Jersey VA veteran demographics.²⁶

Table 1 shows veteran experience and interest in CAM practices. More than half of veterans who returned the survey reported doing either a CAM practice or having done 1 (n = 82; 61%). Many also reported interest in trying at least 1 practice (n = 73; 55%) or learning more about at least 1 practice (n = 71; 53%) either on their own or with an instructor. More veterans indicated they would prefer to try the techniques with an instructor (n = 61; 46%) rather than on their own (n = 26; 19%). Chi-square testing showed that interest and experience with CAM were not significantly associated with specific demographic characteristics.

Several barriers to CAM practice were frequently cited (Table 2). The 2 most commonly endorsed barriers were veterans who wanted to try the techniques but needed more guidance (n = 62; 46%) and heard of CAM but never thought to try them (n = 43; 32%). Only a small percentage of veterans indicated that they did not think the practice would help (n = 13; 10%) or were concerned that it might hurt them (n = 11; 8%).

There were several significant bivariate associations (Table 3), although overall r² values were low. More severe pain was associated with a weaker belief that the techniques could benefit overall wellness (r² = – .19; P = .04) and help daily functioning (r²= – .27; P < .01). Higher health-related self-efficacy was associated with a stronger belief in the techniques’ effectiveness for overall wellness (r²= .30; P < .01) and daily function (r² = .35; P < .01). Higher self-rated health was associated with stronger belief in effectiveness for overall wellness (r² = .20; P = .02) and daily function (r²= .23; P < .01). One-way ANOVAs found no significant associations between belief in the techniques’ effectiveness for wellness or for daily activities (for which statistics are presented here) and positive screens for PTSD (F_1,116 = 3.04; P = .08), depression (F_1,116 = 2.06; P = .15), anxiety (F_1,122 = 1.41; P = .23), or any of the 3 combined (F_1,116 = 3.74; P = .06). None of the health factors was associated with veteran interest in trying a technique or with a history of trying at least 1 technique.

Of the multivariate linear regression models examining associations between veteran characteristics and responses to CAM, only 1 was significant (Table 4). Of all the factors in the model, only self-efficacy was significantly associated with the belief that CAM can improve daily function. Pain moderated this relationship; those with higher pain levels believed CAM could help with daily function only if they also had high self-efficacy (interaction term β = 0.27; SE = 0.03). For example, veterans with no pain (pain score 1 on a scale of 1-10) had a β = .07 (SE .13, P = .28), whereas those with the highest pain level (10) had a β = .92 (SE = .24, P = .001).

Discussion

The authors report 3 main findings from this study: Personal characteristics are not associated with experience, interest in, or belief in the efficacy of CAM; despite a large proportion reporting experience with CAM, veterans reported several barriers to using CAM; and the level of pain reported moderated the relationship between health-related self-efficacy and the belief that CAM will help with daily function.

Determining which personal characteristics are associated with CAM perceptions may indicate who is willing to try CAM techniques and who may require additional education or support. Although the authors hypothesized a difference in experience, interest, and belief of efficacy according to patient characteristics, these differences were not demonstrated. Some published research supports an association between white race, female sex, and middle or younger age and use of CAM, but this sample of veterans did not confirm these associations.^1,3,6-8

The lack of associations may be related to selection bias, reflected in the relatively high report of baseline use of CAM. Nevertheless, this finding implies that clinicians should not make assumptions about an individual’s experience with CAM or interest in trying a modality. From a policy perspective, the VHA should consider a broad-based approach targeting a general audience or multiple segmented audiences to increase awareness and a trial of CAM for veterans.

Barriers should be considered when introducing CAM into routine clinical care. The current study revealed several important barriers to veterans accessing or trying CAM techniques, including need for guidance, the lack of awareness or access, and cost. The VHA services are often provided at low or no cost to eligible veterans, likely mitigating the cost barrier to a great extent. However, being able to easily access instruction in CAM modalities in a timely manner may be just as important. The authors detected a preference among respondents for classes to learn CAM (46%) vs independently (19%), supported by the commonly endorsed barrier to trying CAM of “I want in-person instruction but can’t find it.” Offering CAM modalities that can be taught in a group or individual setting and later practiced independently may be an appropriate approach to introduce CAM techniques to the largest number of people and encourage uptake. This approach can maximize access while satisfying many veterans’ preferences for in-person instruction. This leverage of skilled practitioner time could be extended for some modalities through remote telehealth participation or on-demand instruction, such as online videos or DVDs, including the SWK.

Chronic pain can be a challenge for patients and clinicians to manage, so the role of CAM in pain management is growing.^2,27 The study’s findings suggest that motivating veterans with chronic pain to try CAM may take extra effort by the clinician. Multivariate linear regression modeling showed that respondents with higher pain levels believed CAM could help with their function only if they also had high health-related self-efficacy, whereas those with low pain scores reported this belief even with low self-efficacy. Thus, strong self-efficacy may overpower doubts about CAM that accompany having pain. Conversely, high reported pain levels may reduce self-efficacy and lead to doubts about the benefit of CAM.

In one study, the belief that lifestyle contributes to illness predicted CAM use, which is similar to this study’s finding that health-related self-efficacy predicted CAM use.⁸ Several other studies examined CAM use and self-efficacy, although usually not self-efficacy for general health management. To promote experimentation with CAM, patients with chronic pain may require interventions targeted to increase self-efficacy related to CAM.

Of the 733 surveys distributed to veterans, 134 (18%) responses were received. More than 60% of the respondents had tried a CAM technique, higher rates than reported by most other CAM utilization studies: U.S. prevalence studies range from 29% to 42% of respondents having tried some CAM technique, and studies of veterans or military personnel range from 37% to 50% having tried CAM.^3,5-7 Because these studies asked about CAM generally or about specific practices that do not fully overlap with the independent CAM practices evaluated in the current study, it is difficult to assess how the experiences of the current sample compare with those populations.

Another study asked veterans with multiple sclerosis whether they were interested in trying CAM practices, and 40% responded “yes,” which is similar to 55% in the current study.⁶ It is possible the rate of experience with CAM is higher in the current study due to self-selection of respondents who were interested in the SWK. Another factor may be that some veterans were recruited from VA mental health clinics where independent CAM practices are more frequently offered.⁹ It is also possible that there are regional differences in CAM use; this study took place at a single facility in the northeast U.S., although subsequent phases of the SWK project involved more widespread national dissemination, to be reported in the future.

Limitations

Self-selection and low response rate are limitations in this study. Despite the low response rate, the demographic information of the sample generally resembles the population of veterans at VANJHCS for age, sex, era, health status, and presence of mental health problems.²⁴ Of note, the authors received responses from a wide range of veterans in terms of age, military era, and care setting, including some veterans who do not use the VA. However, data are lacking for nonresponders, and the possibility remains that survey respondents self-selected and were more interested in or experienced with CAM than were nonrespondents. Regardless, many findings, including barriers to CAM and the interaction of pain and self-efficacy, are internally valid and are important to consider even if the sample is not representative of the veteran population.

Conclusion

No studies have focused on veteran use of independent CAM practices as defined for this study. These techniques (eg, meditation, qigong) may promote wellness and relieve common symptoms in veterans. The authors’ results suggest that a broad interest in independent CAM practices among veterans exists. The VA and other health care settings should consider implementing classes in these modalities, especially as their reach may be greater than other CAM modalities requiring one-on-one practitioner-patient interaction. Even with broader availability, patients with chronic pain may require extra attention and context to improve or overcome low health-related self-efficacy, maximizing their likelihood of engaging in CAM. This possibility needs to be explored.

Acknowledgments

Funding for this research was provided by the Veterans Affairs Office of Patient Centered Care and Cultural Transformation, which was not involved in the study design or production of the manuscript. The authors also acknowledge the work of Anna Rusiewicz, PhD, in developing the STAR Well-Kit that was disseminated during this study.

Complementary and alternative medicine (CAM) are health and wellness practices that are outside conventional allopathic medicine. In the U.S., the popularity of CAM has grown, and patients often use CAM to treat pain, insomnia, anxiety, and depression.^1-5 Veterans also have been increasingly adding CAM to conventional medicine, although limited studies exist on veteran use and attitudes toward CAM.^6-8

Recently, the VA has increased its CAM services, offering different treatments at various VA facilities where CAM is most commonly used to treat anxiety, posttraumatic stress disorder (PTSD), depression, and back pain.⁹ Some veterans also seek CAM services outside the VA.^6,8 Across studies of veterans and the broader population, having more years of education and higher income and being middle-aged, female, and white were associated with greater CAM use.^1,3,6-8

Some CAM practices, such as acupuncture, require a practitioner’s regular and direct involvement. Other, independent CAM practices can be taught in classes, individual sessions, or through self-instructional multimedia. Once learned, these practices can be done independently, allowing for easier and less costly access. Independent CAM practices, such as yoga, meditation, breathing exercises, qigong, and tai chi promote general wellness or treat a particular ailment.

Although results have been mixed, several studies support independent CAM practices for treatment and symptom relief. For example, yoga improves symptoms in neurologic and psychiatric disorders, lessens pain, and helps decrease anxiety and depression and improve self-efficacy.^10-13 Qigong can improve hypertensionand self-efficacy.^14,15

This study examines veterans’ attitudes and beliefs about CAM, which can affect their interest and use of CAM services within and outside the VA. The focus is exclusively on independent CAM practices. At the time of the study, the availability of more direct CAM practices, such as acupuncture, was limited at many VA sites, and independently practiced techniques often require fewer resources and, therefore, could be adapted more easily. Subsequent references to CAM in this study refer only to independent CAM practices.

The current study surveyed veterans in New Jersey in multiple VA clinics and non-VA peer-counseling settings as part of an implementation study of a veteran-centric DVD called the STAR (Simple Tools to Aid and Restore) Well-Kit (SWK), which serves as a veteran introduction to CAM.¹⁶ Before watching the DVD, veterans were asked to fill out a baseline survey about their knowledge, attitudes, beliefs, and experiences with CAM as well as answer screening and demographic questions.

The authors describe the findings of the baseline survey to inform how to best implement CAM more broadly throughout VA. They expected that knowledge, attitudes, beliefs, and experiences with CAM would vary by clinical setting and respondent characteristics and hypothesized that psychological factors would be related to interest in CAM. Finally, barriers and facilitators of use of CAM are reported to inform policies to promote veteran access to CAM.

Methods

This cross-sectional analysis of the baseline SWK surveys had no inclusion or exclusion criteria because participation was anonymous. Recipients received a packet that instructed them to complete a previewing survey, watch the DVD, and complete a postviewing survey about the DVD. Surveys were returned in person or by postage-paid envelopes. No follow-up reminders were provided. This study examines data from only the previewing survey, and all further references to the veteran presurvey refers to it as the survey.

Study sites were the outpatient services of the VA New Jersey Health Care System (VANJHCS) and a non-VHA New Jersey veteran peer-counseling office. VANJHCS, which enrolls patients from northern and central New Jersey, offers health care services at 2 campuses and 9 outpatient clinics. Waivers of informed consent were approved by the VANJHCS Institutional Review Board and Research and Development Committee given the anonymous and low-risk nature of the research.

Participant Recruitment

The survey was distributed at 4 settings selected with a focus on ambulatory services and a goal of ensuring participant diversity in age, deployment experience, and mental and physical health conditions. At 3 settings, surveys were distributed using 3 methods: by a researcher; left for pickup in waiting rooms; or by selected health care providers at their discretion in the context of routine clinical visits. The VANJHCS settings were outpatient mental-health clinics, outpatient primary-care settings, and outpatient transition-unit clinics for recent combat veterans. The fourth setting was a community veteran peer-support organization staffed by veterans and included events held at the organization’s offices, veteran informational and health fairs in the community, and outreach events at college campuses. In this setting, veteran peers distributed the SWK at their discretion; they were given suggested talking points for distribution.

Survey Data Collection

Veterans filled out baseline surveys before viewing the SWK DVD. The surveys were anonymous but coded with a number to allow for tracking by setting and dissemination method. The surveys asked for demographic and health information and experience with and interest in CAM techniques. To minimize respondent burden, the authors focused on the most critical domains as summarized in the background section (demographics; health status and symptoms, including pain; self-efficacy; mental health conditions; knowledge, attitudes, and beliefs about CAM).

Demographic Information

Age range was assessed to avoid collecting identifying information. The questionnaire also included gender, military era/deployment, employment status, and race and ethnicity.

• Self-Rated Health (SF1). Self-rated health was assessed with a widely used single-item question that correlates highly with actual overall health and with function and quality of life.^17,18 Respondents were asked to rate their health as excellent (5), very good, good, fair, or poor (1).
•  Pain Screen (PEG 3-item scale). This 3-item screen has shown reliability and validity and is comparable to longer pain questionnaires.¹⁹ Respondents were asked to rate 3 measures of their pain and its consequences on a scale of 0 (no pain or no interference from pain) to 10 (worst pain or interference). Responses were averaged to determine pain score.
•  PTSD Screen. This 4-item PTSD screen was developed for primary care and is widely used in VA settings.²⁰ For each item, respondents were asked to check off whether they have had specific PTSD symptoms within the past month. The screen was considered positive with 3 of 4 affirmative responses.
•  Anxiety and Depression Screen (PHQ-4). This 4-item scale combines the brief 2-item scales for screening anxiety and depression in primary care.²¹ For each depression or anxiety symptom, respondents selected from “not at all,” (1) “several days ”(2), “more days than not,” (3) and “nearly every day.” (4) For each 2-item screen, a sum of 5 or more indicated a positive screen.
• Self-Efficacy for Health Management (modified). The original 6-item self-efficacy screen was developed to test self-efficacy in managing chronic disease.²² Since not all participants in the current study were expected to have a chronic disease, the questions were modified to address more general self-efficacy for health management. Although the scale had not been adapted in this way or validated with this change, other authors have similarly adapted it to address specific chronic diseases with satisfactory results.^23,24 For each item, respondents were asked to rate their confidence in their ability to manage aspects of their health on a scale of 1 (not at all confident) to 10 (very confident). Participants could also check “not applicable” for items that did not apply to their health concerns, and these items were not counted in the average score.
•  Familiarity With and Interest in CAM. The authors developed a checklist to assess whether participants had heard of, tried, or were practicing the 4 CAM techniques featured in the SWK and to gauge their interest in learning about them (ie, meditation/guided imagery, breathing exercises, yoga, tai chi or qigong). For each technique, respondents selected that they have “never heard of,” “heard of but never tried,” “have done this in the past,” or “are currently doing.” For some analyses, the first 2 and last 2 options were combined to determine whether respondents had done each practice. They were also asked to check off whether they would like to learn more about the practice and whether they would like to try it with an instructor and/or try it on their own. For some analyses, each technique was looked at separately, whereas for others, the 4 techniques were combined to determine whether they had tried or were currently doing any of them.
• Barriers to Practice. The authors developed a checklist of 10 barriers to practicing CAM techniques based on research but with adjustments to the specific practices and population under investigation.²⁵ The checklist included an open-end response to allow respondents to add barriers. The barrier list was a checklist and not a validated scale.
•  Perceived Benefits of CAM. The authors developed 2 questions to assess the perceived benefits of these techniques on functionality and overall wellness, rated on a Likert scale from 1 (no benefits) to 10 (very much).

Statistical Analysis

Survey instruments were scored according to generally accepted and published practices. Item-level analysis was performed to identify missing responses and describe the sample. Summary statistics were reported. Pearson product moment correlation was used to detect associations between continuous variables. Analysis of variance (ANOVA) was used to detect associations between dichotomous and continuous variables. Chi-square tests were used to detect associations between categorical variables, specifically looking at clinically meaningful differences between veterans who had experience with or interest in trying independent CAM practices and those who did not. Linear regression analysis was used to determine significant associations between participant characteristics and the belief that independent CAM practices would be helpful with daily function.

Results

The response rate for returning surveys was low (n = 134; 18.2%). Surveys distributed by peers in the community setting had the highest response rate (38%), followed by surveys distributed in primary care (23%).

Due to the anonymous nature of the survey, information on nonresponder characteristics was not available. Respondents covered a range of ages, with 64% of respondents aged ≥ 50 years. Respondents were men (88%) and white (49%) or African American (40%). Fifty-five percent screened positive for at least 1 mental health condition (PTSD, depression, or anxiety). The average self-rated health was 2.9 on a scale of 1 (poor health) to 5 (excellent health). Gender, age range, race, and deployment status were comparable with New Jersey VA veteran demographics.²⁶

Table 1 shows veteran experience and interest in CAM practices. More than half of veterans who returned the survey reported doing either a CAM practice or having done 1 (n = 82; 61%). Many also reported interest in trying at least 1 practice (n = 73; 55%) or learning more about at least 1 practice (n = 71; 53%) either on their own or with an instructor. More veterans indicated they would prefer to try the techniques with an instructor (n = 61; 46%) rather than on their own (n = 26; 19%). Chi-square testing showed that interest and experience with CAM were not significantly associated with specific demographic characteristics.

Several barriers to CAM practice were frequently cited (Table 2). The 2 most commonly endorsed barriers were veterans who wanted to try the techniques but needed more guidance (n = 62; 46%) and heard of CAM but never thought to try them (n = 43; 32%). Only a small percentage of veterans indicated that they did not think the practice would help (n = 13; 10%) or were concerned that it might hurt them (n = 11; 8%).

There were several significant bivariate associations (Table 3), although overall r² values were low. More severe pain was associated with a weaker belief that the techniques could benefit overall wellness (r² = – .19; P = .04) and help daily functioning (r²= – .27; P < .01). Higher health-related self-efficacy was associated with a stronger belief in the techniques’ effectiveness for overall wellness (r²= .30; P < .01) and daily function (r² = .35; P < .01). Higher self-rated health was associated with stronger belief in effectiveness for overall wellness (r² = .20; P = .02) and daily function (r²= .23; P < .01). One-way ANOVAs found no significant associations between belief in the techniques’ effectiveness for wellness or for daily activities (for which statistics are presented here) and positive screens for PTSD (F_1,116 = 3.04; P = .08), depression (F_1,116 = 2.06; P = .15), anxiety (F_1,122 = 1.41; P = .23), or any of the 3 combined (F_1,116 = 3.74; P = .06). None of the health factors was associated with veteran interest in trying a technique or with a history of trying at least 1 technique.

Of the multivariate linear regression models examining associations between veteran characteristics and responses to CAM, only 1 was significant (Table 4). Of all the factors in the model, only self-efficacy was significantly associated with the belief that CAM can improve daily function. Pain moderated this relationship; those with higher pain levels believed CAM could help with daily function only if they also had high self-efficacy (interaction term β = 0.27; SE = 0.03). For example, veterans with no pain (pain score 1 on a scale of 1-10) had a β = .07 (SE .13, P = .28), whereas those with the highest pain level (10) had a β = .92 (SE = .24, P = .001).

Discussion

The authors report 3 main findings from this study: Personal characteristics are not associated with experience, interest in, or belief in the efficacy of CAM; despite a large proportion reporting experience with CAM, veterans reported several barriers to using CAM; and the level of pain reported moderated the relationship between health-related self-efficacy and the belief that CAM will help with daily function.

Determining which personal characteristics are associated with CAM perceptions may indicate who is willing to try CAM techniques and who may require additional education or support. Although the authors hypothesized a difference in experience, interest, and belief of efficacy according to patient characteristics, these differences were not demonstrated. Some published research supports an association between white race, female sex, and middle or younger age and use of CAM, but this sample of veterans did not confirm these associations.^1,3,6-8

The lack of associations may be related to selection bias, reflected in the relatively high report of baseline use of CAM. Nevertheless, this finding implies that clinicians should not make assumptions about an individual’s experience with CAM or interest in trying a modality. From a policy perspective, the VHA should consider a broad-based approach targeting a general audience or multiple segmented audiences to increase awareness and a trial of CAM for veterans.

Barriers should be considered when introducing CAM into routine clinical care. The current study revealed several important barriers to veterans accessing or trying CAM techniques, including need for guidance, the lack of awareness or access, and cost. The VHA services are often provided at low or no cost to eligible veterans, likely mitigating the cost barrier to a great extent. However, being able to easily access instruction in CAM modalities in a timely manner may be just as important. The authors detected a preference among respondents for classes to learn CAM (46%) vs independently (19%), supported by the commonly endorsed barrier to trying CAM of “I want in-person instruction but can’t find it.” Offering CAM modalities that can be taught in a group or individual setting and later practiced independently may be an appropriate approach to introduce CAM techniques to the largest number of people and encourage uptake. This approach can maximize access while satisfying many veterans’ preferences for in-person instruction. This leverage of skilled practitioner time could be extended for some modalities through remote telehealth participation or on-demand instruction, such as online videos or DVDs, including the SWK.

Chronic pain can be a challenge for patients and clinicians to manage, so the role of CAM in pain management is growing.^2,27 The study’s findings suggest that motivating veterans with chronic pain to try CAM may take extra effort by the clinician. Multivariate linear regression modeling showed that respondents with higher pain levels believed CAM could help with their function only if they also had high health-related self-efficacy, whereas those with low pain scores reported this belief even with low self-efficacy. Thus, strong self-efficacy may overpower doubts about CAM that accompany having pain. Conversely, high reported pain levels may reduce self-efficacy and lead to doubts about the benefit of CAM.

In one study, the belief that lifestyle contributes to illness predicted CAM use, which is similar to this study’s finding that health-related self-efficacy predicted CAM use.⁸ Several other studies examined CAM use and self-efficacy, although usually not self-efficacy for general health management. To promote experimentation with CAM, patients with chronic pain may require interventions targeted to increase self-efficacy related to CAM.

Of the 733 surveys distributed to veterans, 134 (18%) responses were received. More than 60% of the respondents had tried a CAM technique, higher rates than reported by most other CAM utilization studies: U.S. prevalence studies range from 29% to 42% of respondents having tried some CAM technique, and studies of veterans or military personnel range from 37% to 50% having tried CAM.^3,5-7 Because these studies asked about CAM generally or about specific practices that do not fully overlap with the independent CAM practices evaluated in the current study, it is difficult to assess how the experiences of the current sample compare with those populations.

Another study asked veterans with multiple sclerosis whether they were interested in trying CAM practices, and 40% responded “yes,” which is similar to 55% in the current study.⁶ It is possible the rate of experience with CAM is higher in the current study due to self-selection of respondents who were interested in the SWK. Another factor may be that some veterans were recruited from VA mental health clinics where independent CAM practices are more frequently offered.⁹ It is also possible that there are regional differences in CAM use; this study took place at a single facility in the northeast U.S., although subsequent phases of the SWK project involved more widespread national dissemination, to be reported in the future.

Limitations

Self-selection and low response rate are limitations in this study. Despite the low response rate, the demographic information of the sample generally resembles the population of veterans at VANJHCS for age, sex, era, health status, and presence of mental health problems.²⁴ Of note, the authors received responses from a wide range of veterans in terms of age, military era, and care setting, including some veterans who do not use the VA. However, data are lacking for nonresponders, and the possibility remains that survey respondents self-selected and were more interested in or experienced with CAM than were nonrespondents. Regardless, many findings, including barriers to CAM and the interaction of pain and self-efficacy, are internally valid and are important to consider even if the sample is not representative of the veteran population.

Conclusion

No studies have focused on veteran use of independent CAM practices as defined for this study. These techniques (eg, meditation, qigong) may promote wellness and relieve common symptoms in veterans. The authors’ results suggest that a broad interest in independent CAM practices among veterans exists. The VA and other health care settings should consider implementing classes in these modalities, especially as their reach may be greater than other CAM modalities requiring one-on-one practitioner-patient interaction. Even with broader availability, patients with chronic pain may require extra attention and context to improve or overcome low health-related self-efficacy, maximizing their likelihood of engaging in CAM. This possibility needs to be explored.

Acknowledgments

Funding for this research was provided by the Veterans Affairs Office of Patient Centered Care and Cultural Transformation, which was not involved in the study design or production of the manuscript. The authors also acknowledge the work of Anna Rusiewicz, PhD, in developing the STAR Well-Kit that was disseminated during this study.

Complementary and alternative medicine (CAM) are health and wellness practices that are outside conventional allopathic medicine. In the U.S., the popularity of CAM has grown, and patients often use CAM to treat pain, insomnia, anxiety, and depression.^1-5 Veterans also have been increasingly adding CAM to conventional medicine, although limited studies exist on veteran use and attitudes toward CAM.^6-8

Recently, the VA has increased its CAM services, offering different treatments at various VA facilities where CAM is most commonly used to treat anxiety, posttraumatic stress disorder (PTSD), depression, and back pain.⁹ Some veterans also seek CAM services outside the VA.^6,8 Across studies of veterans and the broader population, having more years of education and higher income and being middle-aged, female, and white were associated with greater CAM use.^1,3,6-8

Some CAM practices, such as acupuncture, require a practitioner’s regular and direct involvement. Other, independent CAM practices can be taught in classes, individual sessions, or through self-instructional multimedia. Once learned, these practices can be done independently, allowing for easier and less costly access. Independent CAM practices, such as yoga, meditation, breathing exercises, qigong, and tai chi promote general wellness or treat a particular ailment.

Although results have been mixed, several studies support independent CAM practices for treatment and symptom relief. For example, yoga improves symptoms in neurologic and psychiatric disorders, lessens pain, and helps decrease anxiety and depression and improve self-efficacy.^10-13 Qigong can improve hypertensionand self-efficacy.^14,15

This study examines veterans’ attitudes and beliefs about CAM, which can affect their interest and use of CAM services within and outside the VA. The focus is exclusively on independent CAM practices. At the time of the study, the availability of more direct CAM practices, such as acupuncture, was limited at many VA sites, and independently practiced techniques often require fewer resources and, therefore, could be adapted more easily. Subsequent references to CAM in this study refer only to independent CAM practices.

The current study surveyed veterans in New Jersey in multiple VA clinics and non-VA peer-counseling settings as part of an implementation study of a veteran-centric DVD called the STAR (Simple Tools to Aid and Restore) Well-Kit (SWK), which serves as a veteran introduction to CAM.¹⁶ Before watching the DVD, veterans were asked to fill out a baseline survey about their knowledge, attitudes, beliefs, and experiences with CAM as well as answer screening and demographic questions.

The authors describe the findings of the baseline survey to inform how to best implement CAM more broadly throughout VA. They expected that knowledge, attitudes, beliefs, and experiences with CAM would vary by clinical setting and respondent characteristics and hypothesized that psychological factors would be related to interest in CAM. Finally, barriers and facilitators of use of CAM are reported to inform policies to promote veteran access to CAM.

Methods

This cross-sectional analysis of the baseline SWK surveys had no inclusion or exclusion criteria because participation was anonymous. Recipients received a packet that instructed them to complete a previewing survey, watch the DVD, and complete a postviewing survey about the DVD. Surveys were returned in person or by postage-paid envelopes. No follow-up reminders were provided. This study examines data from only the previewing survey, and all further references to the veteran presurvey refers to it as the survey.

Study sites were the outpatient services of the VA New Jersey Health Care System (VANJHCS) and a non-VHA New Jersey veteran peer-counseling office. VANJHCS, which enrolls patients from northern and central New Jersey, offers health care services at 2 campuses and 9 outpatient clinics. Waivers of informed consent were approved by the VANJHCS Institutional Review Board and Research and Development Committee given the anonymous and low-risk nature of the research.

Participant Recruitment

The survey was distributed at 4 settings selected with a focus on ambulatory services and a goal of ensuring participant diversity in age, deployment experience, and mental and physical health conditions. At 3 settings, surveys were distributed using 3 methods: by a researcher; left for pickup in waiting rooms; or by selected health care providers at their discretion in the context of routine clinical visits. The VANJHCS settings were outpatient mental-health clinics, outpatient primary-care settings, and outpatient transition-unit clinics for recent combat veterans. The fourth setting was a community veteran peer-support organization staffed by veterans and included events held at the organization’s offices, veteran informational and health fairs in the community, and outreach events at college campuses. In this setting, veteran peers distributed the SWK at their discretion; they were given suggested talking points for distribution.

Survey Data Collection

Veterans filled out baseline surveys before viewing the SWK DVD. The surveys were anonymous but coded with a number to allow for tracking by setting and dissemination method. The surveys asked for demographic and health information and experience with and interest in CAM techniques. To minimize respondent burden, the authors focused on the most critical domains as summarized in the background section (demographics; health status and symptoms, including pain; self-efficacy; mental health conditions; knowledge, attitudes, and beliefs about CAM).

Demographic Information

Age range was assessed to avoid collecting identifying information. The questionnaire also included gender, military era/deployment, employment status, and race and ethnicity.

• Self-Rated Health (SF1). Self-rated health was assessed with a widely used single-item question that correlates highly with actual overall health and with function and quality of life.^17,18 Respondents were asked to rate their health as excellent (5), very good, good, fair, or poor (1).
•  Pain Screen (PEG 3-item scale). This 3-item screen has shown reliability and validity and is comparable to longer pain questionnaires.¹⁹ Respondents were asked to rate 3 measures of their pain and its consequences on a scale of 0 (no pain or no interference from pain) to 10 (worst pain or interference). Responses were averaged to determine pain score.
•  PTSD Screen. This 4-item PTSD screen was developed for primary care and is widely used in VA settings.²⁰ For each item, respondents were asked to check off whether they have had specific PTSD symptoms within the past month. The screen was considered positive with 3 of 4 affirmative responses.
•  Anxiety and Depression Screen (PHQ-4). This 4-item scale combines the brief 2-item scales for screening anxiety and depression in primary care.²¹ For each depression or anxiety symptom, respondents selected from “not at all,” (1) “several days ”(2), “more days than not,” (3) and “nearly every day.” (4) For each 2-item screen, a sum of 5 or more indicated a positive screen.
• Self-Efficacy for Health Management (modified). The original 6-item self-efficacy screen was developed to test self-efficacy in managing chronic disease.²² Since not all participants in the current study were expected to have a chronic disease, the questions were modified to address more general self-efficacy for health management. Although the scale had not been adapted in this way or validated with this change, other authors have similarly adapted it to address specific chronic diseases with satisfactory results.^23,24 For each item, respondents were asked to rate their confidence in their ability to manage aspects of their health on a scale of 1 (not at all confident) to 10 (very confident). Participants could also check “not applicable” for items that did not apply to their health concerns, and these items were not counted in the average score.
•  Familiarity With and Interest in CAM. The authors developed a checklist to assess whether participants had heard of, tried, or were practicing the 4 CAM techniques featured in the SWK and to gauge their interest in learning about them (ie, meditation/guided imagery, breathing exercises, yoga, tai chi or qigong). For each technique, respondents selected that they have “never heard of,” “heard of but never tried,” “have done this in the past,” or “are currently doing.” For some analyses, the first 2 and last 2 options were combined to determine whether respondents had done each practice. They were also asked to check off whether they would like to learn more about the practice and whether they would like to try it with an instructor and/or try it on their own. For some analyses, each technique was looked at separately, whereas for others, the 4 techniques were combined to determine whether they had tried or were currently doing any of them.
• Barriers to Practice. The authors developed a checklist of 10 barriers to practicing CAM techniques based on research but with adjustments to the specific practices and population under investigation.²⁵ The checklist included an open-end response to allow respondents to add barriers. The barrier list was a checklist and not a validated scale.
•  Perceived Benefits of CAM. The authors developed 2 questions to assess the perceived benefits of these techniques on functionality and overall wellness, rated on a Likert scale from 1 (no benefits) to 10 (very much).

Statistical Analysis

Survey instruments were scored according to generally accepted and published practices. Item-level analysis was performed to identify missing responses and describe the sample. Summary statistics were reported. Pearson product moment correlation was used to detect associations between continuous variables. Analysis of variance (ANOVA) was used to detect associations between dichotomous and continuous variables. Chi-square tests were used to detect associations between categorical variables, specifically looking at clinically meaningful differences between veterans who had experience with or interest in trying independent CAM practices and those who did not. Linear regression analysis was used to determine significant associations between participant characteristics and the belief that independent CAM practices would be helpful with daily function.

Results

The response rate for returning surveys was low (n = 134; 18.2%). Surveys distributed by peers in the community setting had the highest response rate (38%), followed by surveys distributed in primary care (23%).

Due to the anonymous nature of the survey, information on nonresponder characteristics was not available. Respondents covered a range of ages, with 64% of respondents aged ≥ 50 years. Respondents were men (88%) and white (49%) or African American (40%). Fifty-five percent screened positive for at least 1 mental health condition (PTSD, depression, or anxiety). The average self-rated health was 2.9 on a scale of 1 (poor health) to 5 (excellent health). Gender, age range, race, and deployment status were comparable with New Jersey VA veteran demographics.²⁶

Table 1 shows veteran experience and interest in CAM practices. More than half of veterans who returned the survey reported doing either a CAM practice or having done 1 (n = 82; 61%). Many also reported interest in trying at least 1 practice (n = 73; 55%) or learning more about at least 1 practice (n = 71; 53%) either on their own or with an instructor. More veterans indicated they would prefer to try the techniques with an instructor (n = 61; 46%) rather than on their own (n = 26; 19%). Chi-square testing showed that interest and experience with CAM were not significantly associated with specific demographic characteristics.

Several barriers to CAM practice were frequently cited (Table 2). The 2 most commonly endorsed barriers were veterans who wanted to try the techniques but needed more guidance (n = 62; 46%) and heard of CAM but never thought to try them (n = 43; 32%). Only a small percentage of veterans indicated that they did not think the practice would help (n = 13; 10%) or were concerned that it might hurt them (n = 11; 8%).

There were several significant bivariate associations (Table 3), although overall r² values were low. More severe pain was associated with a weaker belief that the techniques could benefit overall wellness (r² = – .19; P = .04) and help daily functioning (r²= – .27; P < .01). Higher health-related self-efficacy was associated with a stronger belief in the techniques’ effectiveness for overall wellness (r²= .30; P < .01) and daily function (r² = .35; P < .01). Higher self-rated health was associated with stronger belief in effectiveness for overall wellness (r² = .20; P = .02) and daily function (r²= .23; P < .01). One-way ANOVAs found no significant associations between belief in the techniques’ effectiveness for wellness or for daily activities (for which statistics are presented here) and positive screens for PTSD (F_1,116 = 3.04; P = .08), depression (F_1,116 = 2.06; P = .15), anxiety (F_1,122 = 1.41; P = .23), or any of the 3 combined (F_1,116 = 3.74; P = .06). None of the health factors was associated with veteran interest in trying a technique or with a history of trying at least 1 technique.

Of the multivariate linear regression models examining associations between veteran characteristics and responses to CAM, only 1 was significant (Table 4). Of all the factors in the model, only self-efficacy was significantly associated with the belief that CAM can improve daily function. Pain moderated this relationship; those with higher pain levels believed CAM could help with daily function only if they also had high self-efficacy (interaction term β = 0.27; SE = 0.03). For example, veterans with no pain (pain score 1 on a scale of 1-10) had a β = .07 (SE .13, P = .28), whereas those with the highest pain level (10) had a β = .92 (SE = .24, P = .001).

Discussion

The authors report 3 main findings from this study: Personal characteristics are not associated with experience, interest in, or belief in the efficacy of CAM; despite a large proportion reporting experience with CAM, veterans reported several barriers to using CAM; and the level of pain reported moderated the relationship between health-related self-efficacy and the belief that CAM will help with daily function.

Determining which personal characteristics are associated with CAM perceptions may indicate who is willing to try CAM techniques and who may require additional education or support. Although the authors hypothesized a difference in experience, interest, and belief of efficacy according to patient characteristics, these differences were not demonstrated. Some published research supports an association between white race, female sex, and middle or younger age and use of CAM, but this sample of veterans did not confirm these associations.^1,3,6-8

The lack of associations may be related to selection bias, reflected in the relatively high report of baseline use of CAM. Nevertheless, this finding implies that clinicians should not make assumptions about an individual’s experience with CAM or interest in trying a modality. From a policy perspective, the VHA should consider a broad-based approach targeting a general audience or multiple segmented audiences to increase awareness and a trial of CAM for veterans.

Barriers should be considered when introducing CAM into routine clinical care. The current study revealed several important barriers to veterans accessing or trying CAM techniques, including need for guidance, the lack of awareness or access, and cost. The VHA services are often provided at low or no cost to eligible veterans, likely mitigating the cost barrier to a great extent. However, being able to easily access instruction in CAM modalities in a timely manner may be just as important. The authors detected a preference among respondents for classes to learn CAM (46%) vs independently (19%), supported by the commonly endorsed barrier to trying CAM of “I want in-person instruction but can’t find it.” Offering CAM modalities that can be taught in a group or individual setting and later practiced independently may be an appropriate approach to introduce CAM techniques to the largest number of people and encourage uptake. This approach can maximize access while satisfying many veterans’ preferences for in-person instruction. This leverage of skilled practitioner time could be extended for some modalities through remote telehealth participation or on-demand instruction, such as online videos or DVDs, including the SWK.

Chronic pain can be a challenge for patients and clinicians to manage, so the role of CAM in pain management is growing.^2,27 The study’s findings suggest that motivating veterans with chronic pain to try CAM may take extra effort by the clinician. Multivariate linear regression modeling showed that respondents with higher pain levels believed CAM could help with their function only if they also had high health-related self-efficacy, whereas those with low pain scores reported this belief even with low self-efficacy. Thus, strong self-efficacy may overpower doubts about CAM that accompany having pain. Conversely, high reported pain levels may reduce self-efficacy and lead to doubts about the benefit of CAM.

In one study, the belief that lifestyle contributes to illness predicted CAM use, which is similar to this study’s finding that health-related self-efficacy predicted CAM use.⁸ Several other studies examined CAM use and self-efficacy, although usually not self-efficacy for general health management. To promote experimentation with CAM, patients with chronic pain may require interventions targeted to increase self-efficacy related to CAM.

Of the 733 surveys distributed to veterans, 134 (18%) responses were received. More than 60% of the respondents had tried a CAM technique, higher rates than reported by most other CAM utilization studies: U.S. prevalence studies range from 29% to 42% of respondents having tried some CAM technique, and studies of veterans or military personnel range from 37% to 50% having tried CAM.^3,5-7 Because these studies asked about CAM generally or about specific practices that do not fully overlap with the independent CAM practices evaluated in the current study, it is difficult to assess how the experiences of the current sample compare with those populations.

Another study asked veterans with multiple sclerosis whether they were interested in trying CAM practices, and 40% responded “yes,” which is similar to 55% in the current study.⁶ It is possible the rate of experience with CAM is higher in the current study due to self-selection of respondents who were interested in the SWK. Another factor may be that some veterans were recruited from VA mental health clinics where independent CAM practices are more frequently offered.⁹ It is also possible that there are regional differences in CAM use; this study took place at a single facility in the northeast U.S., although subsequent phases of the SWK project involved more widespread national dissemination, to be reported in the future.

Limitations

Self-selection and low response rate are limitations in this study. Despite the low response rate, the demographic information of the sample generally resembles the population of veterans at VANJHCS for age, sex, era, health status, and presence of mental health problems.²⁴ Of note, the authors received responses from a wide range of veterans in terms of age, military era, and care setting, including some veterans who do not use the VA. However, data are lacking for nonresponders, and the possibility remains that survey respondents self-selected and were more interested in or experienced with CAM than were nonrespondents. Regardless, many findings, including barriers to CAM and the interaction of pain and self-efficacy, are internally valid and are important to consider even if the sample is not representative of the veteran population.

Conclusion

No studies have focused on veteran use of independent CAM practices as defined for this study. These techniques (eg, meditation, qigong) may promote wellness and relieve common symptoms in veterans. The authors’ results suggest that a broad interest in independent CAM practices among veterans exists. The VA and other health care settings should consider implementing classes in these modalities, especially as their reach may be greater than other CAM modalities requiring one-on-one practitioner-patient interaction. Even with broader availability, patients with chronic pain may require extra attention and context to improve or overcome low health-related self-efficacy, maximizing their likelihood of engaging in CAM. This possibility needs to be explored.

Acknowledgments

Funding for this research was provided by the Veterans Affairs Office of Patient Centered Care and Cultural Transformation, which was not involved in the study design or production of the manuscript. The authors also acknowledge the work of Anna Rusiewicz, PhD, in developing the STAR Well-Kit that was disseminated during this study.

Prescription drugs

Photo by Steven Harbour

Results of an analysis published in The BMJ have raised concerns about how often drug regulators go on to work in the biopharmaceutical industry.

A pair of researchers evaluated 55 medical reviewers who worked at the US Food and Drug Administration (FDA) between 2001 and 2010.

Forty-seven percent of the reviewers left the FDA, and 58% of those who left were subsequently employed by or consulting for the biopharmaceutical industry.

Vinay Prasad, MD, and Jeffrey Bien, MD, both of Oregon Health and Science University in Portland, conducted this research.

The pair began by identifying hematology-oncology drugs approved by the FDA from 2006 to 2010. They then used the FDA database ([email protected]) to compile a list of all medical reviewers for these drugs.

The researchers then searched publicly available information from the Department of Health and Human Services, LinkedIn, and PubMed to determine the reviewers’ subsequent jobs.

The pair identified 55 unique hematology-oncology medical reviewers who reviewed drug applications between 2001 and 2010.

Forty-nine percent (n=27) of these reviewers continue to work exclusively at the FDA. Four percent (n=2) still work at the FDA but hold secondary appointments (1 with a non-FDA-related consulting position and 1 with another government position).

Forty-seven percent (n=26) of the reviewers left the FDA. The researchers were unable to determine subsequent jobs for 14% (n=8) of the reviewers.

However, 27% (n=15) went on to biopharmaceutical industry employment or consulting. Four percent (n=2) went on to other government positions, and 2% (n=1) went on to work in academia.

Drs Prasad and Bien said this analysis is the first to document the rate of the “revolving door” between the FDA and the biopharmaceutical industry, and the results suggest a sizable percentage of FDA medical reviewers who leave the agency subsequently work in the industry.

The researchers said they are concerned by these findings, and they noted that this analysis may have underestimated the extent of the “revolving door” because they could not identify subsequent jobs for all of the reviewers studied.

Prescription drugs

Photo by Steven Harbour

Results of an analysis published in The BMJ have raised concerns about how often drug regulators go on to work in the biopharmaceutical industry.

A pair of researchers evaluated 55 medical reviewers who worked at the US Food and Drug Administration (FDA) between 2001 and 2010.

Forty-seven percent of the reviewers left the FDA, and 58% of those who left were subsequently employed by or consulting for the biopharmaceutical industry.

Vinay Prasad, MD, and Jeffrey Bien, MD, both of Oregon Health and Science University in Portland, conducted this research.

The pair began by identifying hematology-oncology drugs approved by the FDA from 2006 to 2010. They then used the FDA database ([email protected]) to compile a list of all medical reviewers for these drugs.

The researchers then searched publicly available information from the Department of Health and Human Services, LinkedIn, and PubMed to determine the reviewers’ subsequent jobs.

The pair identified 55 unique hematology-oncology medical reviewers who reviewed drug applications between 2001 and 2010.

Forty-nine percent (n=27) of these reviewers continue to work exclusively at the FDA. Four percent (n=2) still work at the FDA but hold secondary appointments (1 with a non-FDA-related consulting position and 1 with another government position).

Forty-seven percent (n=26) of the reviewers left the FDA. The researchers were unable to determine subsequent jobs for 14% (n=8) of the reviewers.

However, 27% (n=15) went on to biopharmaceutical industry employment or consulting. Four percent (n=2) went on to other government positions, and 2% (n=1) went on to work in academia.

Drs Prasad and Bien said this analysis is the first to document the rate of the “revolving door” between the FDA and the biopharmaceutical industry, and the results suggest a sizable percentage of FDA medical reviewers who leave the agency subsequently work in the industry.

The researchers said they are concerned by these findings, and they noted that this analysis may have underestimated the extent of the “revolving door” because they could not identify subsequent jobs for all of the reviewers studied.

Prescription drugs

Photo by Steven Harbour

Results of an analysis published in The BMJ have raised concerns about how often drug regulators go on to work in the biopharmaceutical industry.

A pair of researchers evaluated 55 medical reviewers who worked at the US Food and Drug Administration (FDA) between 2001 and 2010.

Forty-seven percent of the reviewers left the FDA, and 58% of those who left were subsequently employed by or consulting for the biopharmaceutical industry.

Vinay Prasad, MD, and Jeffrey Bien, MD, both of Oregon Health and Science University in Portland, conducted this research.

The pair began by identifying hematology-oncology drugs approved by the FDA from 2006 to 2010. They then used the FDA database ([email protected]) to compile a list of all medical reviewers for these drugs.

The researchers then searched publicly available information from the Department of Health and Human Services, LinkedIn, and PubMed to determine the reviewers’ subsequent jobs.

The pair identified 55 unique hematology-oncology medical reviewers who reviewed drug applications between 2001 and 2010.

Forty-nine percent (n=27) of these reviewers continue to work exclusively at the FDA. Four percent (n=2) still work at the FDA but hold secondary appointments (1 with a non-FDA-related consulting position and 1 with another government position).

Forty-seven percent (n=26) of the reviewers left the FDA. The researchers were unable to determine subsequent jobs for 14% (n=8) of the reviewers.

However, 27% (n=15) went on to biopharmaceutical industry employment or consulting. Four percent (n=2) went on to other government positions, and 2% (n=1) went on to work in academia.

Drs Prasad and Bien said this analysis is the first to document the rate of the “revolving door” between the FDA and the biopharmaceutical industry, and the results suggest a sizable percentage of FDA medical reviewers who leave the agency subsequently work in the industry.

The researchers said they are concerned by these findings, and they noted that this analysis may have underestimated the extent of the “revolving door” because they could not identify subsequent jobs for all of the reviewers studied.

One of the most challenging elements in making a diagnosis of fetal alcohol spectrum disorders is obtaining a thorough history of the mother’s drinking during pregnancy. This is something that ob.gyns. have struggled with for many years, and while there are ways to improve the collection of this information, it’s often an uncomfortable conversation that yields unreliable answers.

In August, a group of experts on fetal alcohol spectrum disorders (FASD), organized by the National Institute on Alcohol Abuse and Alcoholism, proposed new clinical guidelines for diagnosing these disorders, the first update since 2005 (Pediatrics. 2016;138[2]:e20154256). The update creates a more inclusive definition of FASD and puts a greater emphasis on the sometimes subtle physical and behavioral changes that occur in children.

Growth restriction

The updated diagnosis begins with the acknowledgment of maternal drinking during pregnancy and growth restriction in the infant, which the new guidelines set at the 10th percentile. That’s an important change because it significantly increases sensitivity, expanding the number of infants who could be diagnosed by raising the growth restriction threshold from the third percentile. Clinicians must take into account other factors, such as the size of the natural parents and whether growth restriction could be caused by other conditions.

Facial changes

A key component on the FASD diagnosis is the assessment of facial changes. The three typical facial changes that have been used to make this diagnosis since the 1970s include short palpebral fissures, a shallow or lack of philtrum, and a thin vermilion border of the upper lip. Previously, if all three of these facial features were present, a history of maternal drinking was not needed in the diagnosis of fetal alcohol syndrome. If two of the three features were present, it was considered partial fetal alcohol syndrome. Now, if maternal drinking has been determined, it’s not necessary to have all three facial features to make a diagnosis of fetal alcohol syndrome.

For the first time, the guidelines describe other facial changes common in FASD that can be used to diagnose partial fetal alcohol syndrome, including a flat nasal bridge, epicanthal folds, and other signs. Again, the guidelines increase sensitivity and make it likely that more cases will be picked up through these criteria.

Neurobehavioral changes

The most devastating part of FASD are the complex neurobehavioral changes, resulting from damage to the fetal brain. Under the updated guidelines, the authors relaxed the criteria so that children can be diagnosed if they have domains of either intellectual impairment or behavioral changes that are 1.5 standard deviations below the age-adjusted mean, rather than the previous 2 standard deviations.

©Fuse/Thinkstock

The challenge with making this change is that unlike with the facial changes, there’s a lack of specificity in assessing intellectual impairment and behavioral changes. In addition, these issues often emerge with other conditions unrelated to fetal exposure to alcohol.

Sensitivity vs. specificity

Statistically, the authors of the updated guidelines have moved to increase sensitivity, reaching more children who need interventions for the devastating manifestations of FASD. But the price of this expansion of the diagnostic criteria is a decrease in specificity. The authors seek to combat this potential lack of specificity by emphasizing that an FASD diagnosis should be made not by a single clinician but by a multidisciplinary team that includes physicians, a psychologist, social worker, and speech and language specialists.

While a specialized team will certainly help to make a better diagnosis, the literature shows very large variability in obtaining FASD diagnosis by using different guidelines. A May 2016 paper in Alcoholism: Clinical & Experimental Research found wide diagnostic variation of between roughly 5% (using guidelines from the Centers for Disease Control and Prevention) and 60% (using 2006 guidelines from Hoyme et al.) in the same group of alcohol- and drug-exposed children, when five different guidelines were used (doi: 10.1111/acer.13032). This type of variation would not be acceptable in other conditions, such as autism or attention-deficit/hyperactivity disorder, and it highlights a serious unresolved gap in advancing FASD.

Ob.gyn. role

The role for the ob.gyn. is a complicated one, both in terms of diagnosis and prevention of FASD. Quite often the mother is abusing both alcohol and drugs and the infant may be at risk for neonatal abstinence syndrome in addition to FASD. And because alcohol abuse is often chronic, this is an issue that could affect future children.

While there are still many unanswered questions on the genetics of FASD, we do know that it’s not an equal opportunity condition. Mothers who have had a child with the syndrome have a higher likelihood of its occurring with a second child, compared with mothers who drink heavily but did not have a previous child with FASD.

For now, it’s imperative that ob.gyns. continue to ask about drinking in a nonjudgmental way and that they ask this question of all their patients, not just ones they consider to be in high risk populations.

Dr. Koren is professor of physiology/pharmacology at Western University in Ontario. He is the founder of the Motherisk Program. He reported having no relevant financial disclosures. Email him at [email protected].

One of the most challenging elements in making a diagnosis of fetal alcohol spectrum disorders is obtaining a thorough history of the mother’s drinking during pregnancy. This is something that ob.gyns. have struggled with for many years, and while there are ways to improve the collection of this information, it’s often an uncomfortable conversation that yields unreliable answers.

In August, a group of experts on fetal alcohol spectrum disorders (FASD), organized by the National Institute on Alcohol Abuse and Alcoholism, proposed new clinical guidelines for diagnosing these disorders, the first update since 2005 (Pediatrics. 2016;138[2]:e20154256). The update creates a more inclusive definition of FASD and puts a greater emphasis on the sometimes subtle physical and behavioral changes that occur in children.

Growth restriction

The updated diagnosis begins with the acknowledgment of maternal drinking during pregnancy and growth restriction in the infant, which the new guidelines set at the 10th percentile. That’s an important change because it significantly increases sensitivity, expanding the number of infants who could be diagnosed by raising the growth restriction threshold from the third percentile. Clinicians must take into account other factors, such as the size of the natural parents and whether growth restriction could be caused by other conditions.

Facial changes

A key component on the FASD diagnosis is the assessment of facial changes. The three typical facial changes that have been used to make this diagnosis since the 1970s include short palpebral fissures, a shallow or lack of philtrum, and a thin vermilion border of the upper lip. Previously, if all three of these facial features were present, a history of maternal drinking was not needed in the diagnosis of fetal alcohol syndrome. If two of the three features were present, it was considered partial fetal alcohol syndrome. Now, if maternal drinking has been determined, it’s not necessary to have all three facial features to make a diagnosis of fetal alcohol syndrome.

For the first time, the guidelines describe other facial changes common in FASD that can be used to diagnose partial fetal alcohol syndrome, including a flat nasal bridge, epicanthal folds, and other signs. Again, the guidelines increase sensitivity and make it likely that more cases will be picked up through these criteria.

Neurobehavioral changes

The most devastating part of FASD are the complex neurobehavioral changes, resulting from damage to the fetal brain. Under the updated guidelines, the authors relaxed the criteria so that children can be diagnosed if they have domains of either intellectual impairment or behavioral changes that are 1.5 standard deviations below the age-adjusted mean, rather than the previous 2 standard deviations.

©Fuse/Thinkstock

The challenge with making this change is that unlike with the facial changes, there’s a lack of specificity in assessing intellectual impairment and behavioral changes. In addition, these issues often emerge with other conditions unrelated to fetal exposure to alcohol.

Sensitivity vs. specificity

Statistically, the authors of the updated guidelines have moved to increase sensitivity, reaching more children who need interventions for the devastating manifestations of FASD. But the price of this expansion of the diagnostic criteria is a decrease in specificity. The authors seek to combat this potential lack of specificity by emphasizing that an FASD diagnosis should be made not by a single clinician but by a multidisciplinary team that includes physicians, a psychologist, social worker, and speech and language specialists.

While a specialized team will certainly help to make a better diagnosis, the literature shows very large variability in obtaining FASD diagnosis by using different guidelines. A May 2016 paper in Alcoholism: Clinical & Experimental Research found wide diagnostic variation of between roughly 5% (using guidelines from the Centers for Disease Control and Prevention) and 60% (using 2006 guidelines from Hoyme et al.) in the same group of alcohol- and drug-exposed children, when five different guidelines were used (doi: 10.1111/acer.13032). This type of variation would not be acceptable in other conditions, such as autism or attention-deficit/hyperactivity disorder, and it highlights a serious unresolved gap in advancing FASD.

Ob.gyn. role

The role for the ob.gyn. is a complicated one, both in terms of diagnosis and prevention of FASD. Quite often the mother is abusing both alcohol and drugs and the infant may be at risk for neonatal abstinence syndrome in addition to FASD. And because alcohol abuse is often chronic, this is an issue that could affect future children.

While there are still many unanswered questions on the genetics of FASD, we do know that it’s not an equal opportunity condition. Mothers who have had a child with the syndrome have a higher likelihood of its occurring with a second child, compared with mothers who drink heavily but did not have a previous child with FASD.

For now, it’s imperative that ob.gyns. continue to ask about drinking in a nonjudgmental way and that they ask this question of all their patients, not just ones they consider to be in high risk populations.

Dr. Koren is professor of physiology/pharmacology at Western University in Ontario. He is the founder of the Motherisk Program. He reported having no relevant financial disclosures. Email him at [email protected].

One of the most challenging elements in making a diagnosis of fetal alcohol spectrum disorders is obtaining a thorough history of the mother’s drinking during pregnancy. This is something that ob.gyns. have struggled with for many years, and while there are ways to improve the collection of this information, it’s often an uncomfortable conversation that yields unreliable answers.

In August, a group of experts on fetal alcohol spectrum disorders (FASD), organized by the National Institute on Alcohol Abuse and Alcoholism, proposed new clinical guidelines for diagnosing these disorders, the first update since 2005 (Pediatrics. 2016;138[2]:e20154256). The update creates a more inclusive definition of FASD and puts a greater emphasis on the sometimes subtle physical and behavioral changes that occur in children.

Growth restriction

The updated diagnosis begins with the acknowledgment of maternal drinking during pregnancy and growth restriction in the infant, which the new guidelines set at the 10th percentile. That’s an important change because it significantly increases sensitivity, expanding the number of infants who could be diagnosed by raising the growth restriction threshold from the third percentile. Clinicians must take into account other factors, such as the size of the natural parents and whether growth restriction could be caused by other conditions.

Facial changes

A key component on the FASD diagnosis is the assessment of facial changes. The three typical facial changes that have been used to make this diagnosis since the 1970s include short palpebral fissures, a shallow or lack of philtrum, and a thin vermilion border of the upper lip. Previously, if all three of these facial features were present, a history of maternal drinking was not needed in the diagnosis of fetal alcohol syndrome. If two of the three features were present, it was considered partial fetal alcohol syndrome. Now, if maternal drinking has been determined, it’s not necessary to have all three facial features to make a diagnosis of fetal alcohol syndrome.

For the first time, the guidelines describe other facial changes common in FASD that can be used to diagnose partial fetal alcohol syndrome, including a flat nasal bridge, epicanthal folds, and other signs. Again, the guidelines increase sensitivity and make it likely that more cases will be picked up through these criteria.

Neurobehavioral changes

The most devastating part of FASD are the complex neurobehavioral changes, resulting from damage to the fetal brain. Under the updated guidelines, the authors relaxed the criteria so that children can be diagnosed if they have domains of either intellectual impairment or behavioral changes that are 1.5 standard deviations below the age-adjusted mean, rather than the previous 2 standard deviations.

©Fuse/Thinkstock

The challenge with making this change is that unlike with the facial changes, there’s a lack of specificity in assessing intellectual impairment and behavioral changes. In addition, these issues often emerge with other conditions unrelated to fetal exposure to alcohol.

Sensitivity vs. specificity

Statistically, the authors of the updated guidelines have moved to increase sensitivity, reaching more children who need interventions for the devastating manifestations of FASD. But the price of this expansion of the diagnostic criteria is a decrease in specificity. The authors seek to combat this potential lack of specificity by emphasizing that an FASD diagnosis should be made not by a single clinician but by a multidisciplinary team that includes physicians, a psychologist, social worker, and speech and language specialists.

While a specialized team will certainly help to make a better diagnosis, the literature shows very large variability in obtaining FASD diagnosis by using different guidelines. A May 2016 paper in Alcoholism: Clinical & Experimental Research found wide diagnostic variation of between roughly 5% (using guidelines from the Centers for Disease Control and Prevention) and 60% (using 2006 guidelines from Hoyme et al.) in the same group of alcohol- and drug-exposed children, when five different guidelines were used (doi: 10.1111/acer.13032). This type of variation would not be acceptable in other conditions, such as autism or attention-deficit/hyperactivity disorder, and it highlights a serious unresolved gap in advancing FASD.

Ob.gyn. role

The role for the ob.gyn. is a complicated one, both in terms of diagnosis and prevention of FASD. Quite often the mother is abusing both alcohol and drugs and the infant may be at risk for neonatal abstinence syndrome in addition to FASD. And because alcohol abuse is often chronic, this is an issue that could affect future children.

While there are still many unanswered questions on the genetics of FASD, we do know that it’s not an equal opportunity condition. Mothers who have had a child with the syndrome have a higher likelihood of its occurring with a second child, compared with mothers who drink heavily but did not have a previous child with FASD.

For now, it’s imperative that ob.gyns. continue to ask about drinking in a nonjudgmental way and that they ask this question of all their patients, not just ones they consider to be in high risk populations.

Dr. Koren is professor of physiology/pharmacology at Western University in Ontario. He is the founder of the Motherisk Program. He reported having no relevant financial disclosures. Email him at [email protected].