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Intraocular Lens Offers Better Vision to Patients With Cataracts
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.
Updated Guideline for Acute Diarrheal Infection
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.
Risk-Assessment Models Are Unreliable Predictors of Venous Thromboembolism
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.
Veteran Perceptions, Interest, and Use of Complementary and Alternative Medicine
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 (F1,116 = 3.04; P = .08), depression (F1,116 = 2.06; P = .15), anxiety (F1,122 = 1.41; P = .23), or any of the 3 combined (F1,116 = 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.
1. Eisenberg DM, Kessler RC, Van Rompay MI, et al. Perceptions about complementary therapies relative to conventional therapies among adults who use both: results from a national survey. Ann Intern Med. 2001;135(5):344-351.
2. Barnes PM, Bloom B, Nahin RL. Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Report. 2008;(12):1-23.
3. Frass M, Strassl RP, Friehs H, Müllner M, Kundi M, Kaye AD. Use and acceptance of complementary and alternative medicine among the general population and medical personnel: a systematic review. Ochsner J. 2012;12(1):45-56.
4. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL. Unconventional medicine in the United States. Prevalence, costs, and patterns of use. N Engl J Med. 1993;328(4):246-252.
5. Smith TC, Ryan MA, Smith B, et al. Complementary and alternative medicine use among US Navy and Marine Corps personnel. BMC Complement Altern Med. 2007;7:16.
6. Campbell DG, Turner AP, Williams RM, et al. Complementary and alternative medicine use in veterans with multiple sclerosis: prevalence and demographic associations. J Rehabil Res Dev. 2006;43(1):99-110.
7. Baldwin CM, Long K, Kroesen K, Brooks AJ, Bell IR. A profile of military veterans in the southwestern United States who use complementary and alternative medicine: implications for integrated care. Arch Intern Med. 2002;162(15):1697-1704.
8. McEachrane-Gross FP, Liebschutz JM, Berlowitz D. Use of selected complementary and alternative medicine (CAM) treatments in veterans with cancer or chronic pain: a cross-sectional survey. BMC Complement Altern Med. 2006;6:34.
9. Ezeji-Okoye SC, Kotar TM, Smeeding SJ, Durfee JM. State of care: complementary and alternative medicine in Veterans Health Administration—2011 survey results. Fed Pract. 2013;30(11):14-19.
10. Cabral P, Meyer HB, Ames D. Effectiveness of yoga therapy as a complementary treatment for major psychiatric disorders: a meta-analysis. Prim Care Companion CNS Disord. 2011;13(4).
11. Büssing A, Ostermann T, Lüdtke R, Michalsen A. Effects of yoga interventions on pain and pain-associated disability: a meta-analysis. J Pain. 2012;13(1):1-9.
12. Lee SW, Mancuso CA, Charlson ME. Prospective study of new participants in a community-based mind-body training program. J Gen Intern Med. 2004;19(7):760-765.
13. Waelde LC, Thompson L, Gallagher-Thompson D. A pilot study of a yoga and meditation intervention for dementia caregiver stress. J Clin Psychol. 2004;60(6):677-687.
14. Lee MS, Lee MS, Kim HJ, Choi ES. Effects of qigong on blood pressure, high-density lipoprotein cholesterol and other lipid levels in essential hypertension patients. Int J Neurosci. 2004;114(7):777-786.
15. Lee MS, Lim HJ, Lee MS. Impact of qigong exercise on self-efficacy and other cognitive perceptual variables in patients with essential hypertension. J Altern Complement Med. 2004;10(4):675-680.
16. U.S. Department of Veterans Affairs, War Related Illness & Injury Study Center. STAR Well-Kit. http://www.warrelatedillness.va.gov/WARRELATEDILLNESS/education/STAR/index.asp. Updated September 18, 2015. Accessed July 6, 2016.
17. Benyamini Y, Idler EL, Leventhal H, Leventhal EA. Positive affect and function as influences on self-assessments of health: expanding our view beyond illness and disability. J Gerontol B Psychol Sci Soc Sci. 2000;55(2):P107-P116.
18. Idler EL, Kasl SV. Self-ratings of health: do they also predict change in functional ability? J Gerontol B Psychol Sci Soc Sci. 1995;50(6):S344-S353.
19. Krebs EE, Lorenz KA, Bair MJ, et al. Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J Gen Intern Med. 2009;24(6):733-738.
20. Prins A, Ouimette P, Kimerling R, et al. The primary care PTSD screen (PC-PTSD): development and operating characteristics. Primary Care Psychiatry. 2003;9(1):9-14.
21. Kroenke K. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009;50(6):613-621.
22. Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001;4(6):256-262.
23. Kim MT, Han HR, Song HJ, et al. A community-based, culturally tailored behavioral intervention for Korean Americans with type 2 diabetes. Diabetes Educ. 2009;35(6):986-994.
24. Webel AR, Okonsky J. Psychometric properties of a Symptom Management Self-Efficacy Scale for women living with HIV/AIDS. J Pain Symptom Manage. 2011;41(3):549-557.
25. Jain N, Astin JA. Barriers to acceptance: an exploratory study of complementary/alternative medicine disuse. J Altern Complement Med. 2001;7(6):689-696.
26. U.S. Department of Veterans Affairs, National Center for Veterans Analysis and Statistics. VA facilities by state. http://www.va.gov/vetdata. Updated June 3, 2016. Accessed July 6, 2016.
27. Hassett AL, Williams DA. Non-pharmacological treatment of chronic widespread musculoskeletal pain. Best Pract Res Clin Rheumatol. 2011;25(2):299-309.
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 (F1,116 = 3.04; P = .08), depression (F1,116 = 2.06; P = .15), anxiety (F1,122 = 1.41; P = .23), or any of the 3 combined (F1,116 = 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 (F1,116 = 3.04; P = .08), depression (F1,116 = 2.06; P = .15), anxiety (F1,122 = 1.41; P = .23), or any of the 3 combined (F1,116 = 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.
1. Eisenberg DM, Kessler RC, Van Rompay MI, et al. Perceptions about complementary therapies relative to conventional therapies among adults who use both: results from a national survey. Ann Intern Med. 2001;135(5):344-351.
2. Barnes PM, Bloom B, Nahin RL. Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Report. 2008;(12):1-23.
3. Frass M, Strassl RP, Friehs H, Müllner M, Kundi M, Kaye AD. Use and acceptance of complementary and alternative medicine among the general population and medical personnel: a systematic review. Ochsner J. 2012;12(1):45-56.
4. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL. Unconventional medicine in the United States. Prevalence, costs, and patterns of use. N Engl J Med. 1993;328(4):246-252.
5. Smith TC, Ryan MA, Smith B, et al. Complementary and alternative medicine use among US Navy and Marine Corps personnel. BMC Complement Altern Med. 2007;7:16.
6. Campbell DG, Turner AP, Williams RM, et al. Complementary and alternative medicine use in veterans with multiple sclerosis: prevalence and demographic associations. J Rehabil Res Dev. 2006;43(1):99-110.
7. Baldwin CM, Long K, Kroesen K, Brooks AJ, Bell IR. A profile of military veterans in the southwestern United States who use complementary and alternative medicine: implications for integrated care. Arch Intern Med. 2002;162(15):1697-1704.
8. McEachrane-Gross FP, Liebschutz JM, Berlowitz D. Use of selected complementary and alternative medicine (CAM) treatments in veterans with cancer or chronic pain: a cross-sectional survey. BMC Complement Altern Med. 2006;6:34.
9. Ezeji-Okoye SC, Kotar TM, Smeeding SJ, Durfee JM. State of care: complementary and alternative medicine in Veterans Health Administration—2011 survey results. Fed Pract. 2013;30(11):14-19.
10. Cabral P, Meyer HB, Ames D. Effectiveness of yoga therapy as a complementary treatment for major psychiatric disorders: a meta-analysis. Prim Care Companion CNS Disord. 2011;13(4).
11. Büssing A, Ostermann T, Lüdtke R, Michalsen A. Effects of yoga interventions on pain and pain-associated disability: a meta-analysis. J Pain. 2012;13(1):1-9.
12. Lee SW, Mancuso CA, Charlson ME. Prospective study of new participants in a community-based mind-body training program. J Gen Intern Med. 2004;19(7):760-765.
13. Waelde LC, Thompson L, Gallagher-Thompson D. A pilot study of a yoga and meditation intervention for dementia caregiver stress. J Clin Psychol. 2004;60(6):677-687.
14. Lee MS, Lee MS, Kim HJ, Choi ES. Effects of qigong on blood pressure, high-density lipoprotein cholesterol and other lipid levels in essential hypertension patients. Int J Neurosci. 2004;114(7):777-786.
15. Lee MS, Lim HJ, Lee MS. Impact of qigong exercise on self-efficacy and other cognitive perceptual variables in patients with essential hypertension. J Altern Complement Med. 2004;10(4):675-680.
16. U.S. Department of Veterans Affairs, War Related Illness & Injury Study Center. STAR Well-Kit. http://www.warrelatedillness.va.gov/WARRELATEDILLNESS/education/STAR/index.asp. Updated September 18, 2015. Accessed July 6, 2016.
17. Benyamini Y, Idler EL, Leventhal H, Leventhal EA. Positive affect and function as influences on self-assessments of health: expanding our view beyond illness and disability. J Gerontol B Psychol Sci Soc Sci. 2000;55(2):P107-P116.
18. Idler EL, Kasl SV. Self-ratings of health: do they also predict change in functional ability? J Gerontol B Psychol Sci Soc Sci. 1995;50(6):S344-S353.
19. Krebs EE, Lorenz KA, Bair MJ, et al. Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J Gen Intern Med. 2009;24(6):733-738.
20. Prins A, Ouimette P, Kimerling R, et al. The primary care PTSD screen (PC-PTSD): development and operating characteristics. Primary Care Psychiatry. 2003;9(1):9-14.
21. Kroenke K. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009;50(6):613-621.
22. Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001;4(6):256-262.
23. Kim MT, Han HR, Song HJ, et al. A community-based, culturally tailored behavioral intervention for Korean Americans with type 2 diabetes. Diabetes Educ. 2009;35(6):986-994.
24. Webel AR, Okonsky J. Psychometric properties of a Symptom Management Self-Efficacy Scale for women living with HIV/AIDS. J Pain Symptom Manage. 2011;41(3):549-557.
25. Jain N, Astin JA. Barriers to acceptance: an exploratory study of complementary/alternative medicine disuse. J Altern Complement Med. 2001;7(6):689-696.
26. U.S. Department of Veterans Affairs, National Center for Veterans Analysis and Statistics. VA facilities by state. http://www.va.gov/vetdata. Updated June 3, 2016. Accessed July 6, 2016.
27. Hassett AL, Williams DA. Non-pharmacological treatment of chronic widespread musculoskeletal pain. Best Pract Res Clin Rheumatol. 2011;25(2):299-309.
1. Eisenberg DM, Kessler RC, Van Rompay MI, et al. Perceptions about complementary therapies relative to conventional therapies among adults who use both: results from a national survey. Ann Intern Med. 2001;135(5):344-351.
2. Barnes PM, Bloom B, Nahin RL. Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Report. 2008;(12):1-23.
3. Frass M, Strassl RP, Friehs H, Müllner M, Kundi M, Kaye AD. Use and acceptance of complementary and alternative medicine among the general population and medical personnel: a systematic review. Ochsner J. 2012;12(1):45-56.
4. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL. Unconventional medicine in the United States. Prevalence, costs, and patterns of use. N Engl J Med. 1993;328(4):246-252.
5. Smith TC, Ryan MA, Smith B, et al. Complementary and alternative medicine use among US Navy and Marine Corps personnel. BMC Complement Altern Med. 2007;7:16.
6. Campbell DG, Turner AP, Williams RM, et al. Complementary and alternative medicine use in veterans with multiple sclerosis: prevalence and demographic associations. J Rehabil Res Dev. 2006;43(1):99-110.
7. Baldwin CM, Long K, Kroesen K, Brooks AJ, Bell IR. A profile of military veterans in the southwestern United States who use complementary and alternative medicine: implications for integrated care. Arch Intern Med. 2002;162(15):1697-1704.
8. McEachrane-Gross FP, Liebschutz JM, Berlowitz D. Use of selected complementary and alternative medicine (CAM) treatments in veterans with cancer or chronic pain: a cross-sectional survey. BMC Complement Altern Med. 2006;6:34.
9. Ezeji-Okoye SC, Kotar TM, Smeeding SJ, Durfee JM. State of care: complementary and alternative medicine in Veterans Health Administration—2011 survey results. Fed Pract. 2013;30(11):14-19.
10. Cabral P, Meyer HB, Ames D. Effectiveness of yoga therapy as a complementary treatment for major psychiatric disorders: a meta-analysis. Prim Care Companion CNS Disord. 2011;13(4).
11. Büssing A, Ostermann T, Lüdtke R, Michalsen A. Effects of yoga interventions on pain and pain-associated disability: a meta-analysis. J Pain. 2012;13(1):1-9.
12. Lee SW, Mancuso CA, Charlson ME. Prospective study of new participants in a community-based mind-body training program. J Gen Intern Med. 2004;19(7):760-765.
13. Waelde LC, Thompson L, Gallagher-Thompson D. A pilot study of a yoga and meditation intervention for dementia caregiver stress. J Clin Psychol. 2004;60(6):677-687.
14. Lee MS, Lee MS, Kim HJ, Choi ES. Effects of qigong on blood pressure, high-density lipoprotein cholesterol and other lipid levels in essential hypertension patients. Int J Neurosci. 2004;114(7):777-786.
15. Lee MS, Lim HJ, Lee MS. Impact of qigong exercise on self-efficacy and other cognitive perceptual variables in patients with essential hypertension. J Altern Complement Med. 2004;10(4):675-680.
16. U.S. Department of Veterans Affairs, War Related Illness & Injury Study Center. STAR Well-Kit. http://www.warrelatedillness.va.gov/WARRELATEDILLNESS/education/STAR/index.asp. Updated September 18, 2015. Accessed July 6, 2016.
17. Benyamini Y, Idler EL, Leventhal H, Leventhal EA. Positive affect and function as influences on self-assessments of health: expanding our view beyond illness and disability. J Gerontol B Psychol Sci Soc Sci. 2000;55(2):P107-P116.
18. Idler EL, Kasl SV. Self-ratings of health: do they also predict change in functional ability? J Gerontol B Psychol Sci Soc Sci. 1995;50(6):S344-S353.
19. Krebs EE, Lorenz KA, Bair MJ, et al. Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J Gen Intern Med. 2009;24(6):733-738.
20. Prins A, Ouimette P, Kimerling R, et al. The primary care PTSD screen (PC-PTSD): development and operating characteristics. Primary Care Psychiatry. 2003;9(1):9-14.
21. Kroenke K. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009;50(6):613-621.
22. Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001;4(6):256-262.
23. Kim MT, Han HR, Song HJ, et al. A community-based, culturally tailored behavioral intervention for Korean Americans with type 2 diabetes. Diabetes Educ. 2009;35(6):986-994.
24. Webel AR, Okonsky J. Psychometric properties of a Symptom Management Self-Efficacy Scale for women living with HIV/AIDS. J Pain Symptom Manage. 2011;41(3):549-557.
25. Jain N, Astin JA. Barriers to acceptance: an exploratory study of complementary/alternative medicine disuse. J Altern Complement Med. 2001;7(6):689-696.
26. U.S. Department of Veterans Affairs, National Center for Veterans Analysis and Statistics. VA facilities by state. http://www.va.gov/vetdata. Updated June 3, 2016. Accessed July 6, 2016.
27. Hassett AL, Williams DA. Non-pharmacological treatment of chronic widespread musculoskeletal pain. Best Pract Res Clin Rheumatol. 2011;25(2):299-309.
Analysis raises concerns about FDA reviewers
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.
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.
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.
New FASD diagnosis guidelines: Comprehensive or overly broad?
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.
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.
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.
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].
The importance of studying the placenta
It makes logical, intellectual sense that the placenta, an organ that is so integrally involved in pregnancy, will be of such great importance to the well-being, sustenance, and growth and development of the fetus. After all, the placental compartment and fetal compartment have the same origin early in embryogenesis, and the placenta is the sole source of nutrients and oxygen for the fetus.
However, the placenta has been extraordinarily poorly understood. Much of medicine has regarded the placenta like the appendix – an organ that may be easily discarded. We know too little about its functions and its biology. We do not even know whether there is a minimum amount of placenta that’s necessary for fetal health.
Over the years, the National Institutes of Health (NIH) has placed an emphasis on certain key areas of study through efforts such as the Human Genome Project, the BRAIN Initiative, and the Cancer Moonshot. Such efforts involve sustained, fundamental research and usually lead to significant findings and subsequent application of the findings.
It is exciting to know that the NIH has launched its Human Placenta Project in an effort to better understand the biology of the placenta and to elucidate its functions. The technology that is employed will play an adjunctive role.
Fortunately, over the years various investigators have studied the placenta using ultrasound, color Doppler technology, and other techniques, and have reported important findings. The work of pathologist Carolyn M. Salafia, MD, and others has called attention to the importance of the shape and vasculature of the placenta, as well as blood flow.
To bring us up to date, as the NIH’s Human Placenta Project proceeds, I have asked Dr. Salafia to provide us with a review discussion of our current knowledge and its implications. Dr. Salafia specializes in reproductive and developmental pathology and reviews thousands of placentas each year through her work with various hospitals and as head of the Placental Modulation Laboratory at the Institute for Basic Research in Developmental Disabilities in Staten Island, N.Y.
Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].
It makes logical, intellectual sense that the placenta, an organ that is so integrally involved in pregnancy, will be of such great importance to the well-being, sustenance, and growth and development of the fetus. After all, the placental compartment and fetal compartment have the same origin early in embryogenesis, and the placenta is the sole source of nutrients and oxygen for the fetus.
However, the placenta has been extraordinarily poorly understood. Much of medicine has regarded the placenta like the appendix – an organ that may be easily discarded. We know too little about its functions and its biology. We do not even know whether there is a minimum amount of placenta that’s necessary for fetal health.
Over the years, the National Institutes of Health (NIH) has placed an emphasis on certain key areas of study through efforts such as the Human Genome Project, the BRAIN Initiative, and the Cancer Moonshot. Such efforts involve sustained, fundamental research and usually lead to significant findings and subsequent application of the findings.
It is exciting to know that the NIH has launched its Human Placenta Project in an effort to better understand the biology of the placenta and to elucidate its functions. The technology that is employed will play an adjunctive role.
Fortunately, over the years various investigators have studied the placenta using ultrasound, color Doppler technology, and other techniques, and have reported important findings. The work of pathologist Carolyn M. Salafia, MD, and others has called attention to the importance of the shape and vasculature of the placenta, as well as blood flow.
To bring us up to date, as the NIH’s Human Placenta Project proceeds, I have asked Dr. Salafia to provide us with a review discussion of our current knowledge and its implications. Dr. Salafia specializes in reproductive and developmental pathology and reviews thousands of placentas each year through her work with various hospitals and as head of the Placental Modulation Laboratory at the Institute for Basic Research in Developmental Disabilities in Staten Island, N.Y.
Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].
It makes logical, intellectual sense that the placenta, an organ that is so integrally involved in pregnancy, will be of such great importance to the well-being, sustenance, and growth and development of the fetus. After all, the placental compartment and fetal compartment have the same origin early in embryogenesis, and the placenta is the sole source of nutrients and oxygen for the fetus.
However, the placenta has been extraordinarily poorly understood. Much of medicine has regarded the placenta like the appendix – an organ that may be easily discarded. We know too little about its functions and its biology. We do not even know whether there is a minimum amount of placenta that’s necessary for fetal health.
Over the years, the National Institutes of Health (NIH) has placed an emphasis on certain key areas of study through efforts such as the Human Genome Project, the BRAIN Initiative, and the Cancer Moonshot. Such efforts involve sustained, fundamental research and usually lead to significant findings and subsequent application of the findings.
It is exciting to know that the NIH has launched its Human Placenta Project in an effort to better understand the biology of the placenta and to elucidate its functions. The technology that is employed will play an adjunctive role.
Fortunately, over the years various investigators have studied the placenta using ultrasound, color Doppler technology, and other techniques, and have reported important findings. The work of pathologist Carolyn M. Salafia, MD, and others has called attention to the importance of the shape and vasculature of the placenta, as well as blood flow.
To bring us up to date, as the NIH’s Human Placenta Project proceeds, I have asked Dr. Salafia to provide us with a review discussion of our current knowledge and its implications. Dr. Salafia specializes in reproductive and developmental pathology and reviews thousands of placentas each year through her work with various hospitals and as head of the Placental Modulation Laboratory at the Institute for Basic Research in Developmental Disabilities in Staten Island, N.Y.
Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].
The Power of Two: Revisiting PA Autonomy
PA autonomy is a hot topic lately—not just within the profession but also in the public press. Earlier this year, Forbes touted efforts to loosen “barriers” to PA practice.1 The American Academy of Physician Assistants has identified 10 federal regulations that impose “unnecessary barriers” to medical care provided by PAs; these include cumbersome countersignatures, unnecessary supervision, and ordering restrictions on everything from home care to diabetic shoes.2 Lifting these barriers makes sense amid a shortage of physicians and an influx of newly insured patients (for more on this topic, see here). But as we acquire greater autonomy, we must not lose sight of the relationship that our profession was founded on—and that makes it unique.
Many PAs aspire to be truly independent practitioners, and some already are (eg, in remote and rural areas). Those of us who practice more closely with physicians may be more apt to appreciate the PA-physician partnership. In my 12 years as a PA, I have partnered with more than 50 physicians in cardiology, internal medicine, gastroenterology, and surgical oncology. I have also had the opportunity to witness the dynamic of other PA-physician relationships. As with all relationships, there is a wide range in synergy, productivity, and trust. Some ill-fated relationships are toxic and nonproductive; those merit a swift exit. At the other end of the spectrum are star-crossed partnerships that radiate competence, creativity, and confidence. In between these two extremes are the majority of PA-physician duos, working it out day to day in a kaleidoscopic health care world. It is clear that the physicians and PAs who not only work hard individually, but also work well within their relationship, benefit the most—and so do their patients.
We surgical PAs have a privileged bond that forms at the operating table. It is not only essential, but empowering, to know what each surgeon is thinking about his or her patient as the case unfolds. In medicine, collaboration may not be as intimate as it is in surgery. Still, there is no substitute for knowing our physicians well. Are our treatment goals in sync with theirs? Are we saying the same things to our patients? When we differ (as we often do), how do we achieve respectful and creative dissention? Can we each do our own thing and still be a credible and productive team?
What exactly is PA autonomy? Our scope of practice is delegated by a supervising physician and is limited to the services for which the physician can provide adequate supervision. The terms of supervision vary by state and by practice. In some states, a PA can have multiple “substitute” supervisors, as long as someone keeps a current list. The primary physician supervisor may or may not be the one the PA works with most closely. Some supervisory relationships are merely paper ones, a de rigueur document for the licensing file. Whatever form it takes, supervision has legal and clinical implications that should be implicit to both parties.
If supervision changes drastically, and PA autonomy becomes a reality, the name of our profession would have to change. Physician associate has been proposed. But until we eliminate the word physician, we are still partners with the very profession from which we intend to secede. Certainly, we need to abolish the possessive physician’s (a semantic that rankles universally). Let us get rid of that annoying (and misleading) apostrophe once and for all.
Many of us chose to become PAs to be extenders, rather than bearing ultimate responsibility. That is not to say that we are not willing to make decisions, take risks, or accept liability—that comes with the license and the territory. But in choosing to assist, we have deliberately chosen a dependent role. While physician assistant indeed implies a subordinate relationship, it is not necessarily a subservient one. There is plenty of room for both shared and separate decision-making, for specifically delegated or situational authority. The PA-physician relationship is built on mutual trust that is earned and reinforced on a daily basis. Decisional confidence and technical competence—not wimpy dependence—is the product of a dynamic PA-physician relationship.
As the health care market changes, we can and should afford ourselves every professional opportunity to work as salaried providers or to sign on as single contractors. There are many alternative PA-physician relationships, both legally and financially. If we so desire, we should pursue advanced degrees and specialty certifications and be compensated accordingly. However, multi-tasseled resumes should remain optional. They are costly and not within the reach of everyone, nor do they necessarily make a better PA.
In this new age of autonomy for advanced practice providers, some will say that only a dinosaur could have made these comments. If that is true, thank you for allowing me to wag my tail. The fact remains that PAs offer something unique. In an era of serious physician shortages, we offer patients the opportunity to have both a relationship with their internist, surgeon, or specialist and access to our own capable care and treatment. This is the “package deal” that, sadly, is in danger of becoming overlooked—if not extinct.
1. Japsen B. States remove barriers to physician assistants . Forbes. March 6, 2016. www.forbes.com/sites/brucejapsen/2016/03/06/states-remove-barriers-to-physician-assistants. Accessed September 13, 2016.
2. American Academy of Physician Assistants. Top ten federal laws & regulations imposing unnecessary barriers to medical care provided by PAs. www.aapa.org/workarea/downloadasset.aspx?id=6442450999. Accessed September 13, 2016.
PA autonomy is a hot topic lately—not just within the profession but also in the public press. Earlier this year, Forbes touted efforts to loosen “barriers” to PA practice.1 The American Academy of Physician Assistants has identified 10 federal regulations that impose “unnecessary barriers” to medical care provided by PAs; these include cumbersome countersignatures, unnecessary supervision, and ordering restrictions on everything from home care to diabetic shoes.2 Lifting these barriers makes sense amid a shortage of physicians and an influx of newly insured patients (for more on this topic, see here). But as we acquire greater autonomy, we must not lose sight of the relationship that our profession was founded on—and that makes it unique.
Many PAs aspire to be truly independent practitioners, and some already are (eg, in remote and rural areas). Those of us who practice more closely with physicians may be more apt to appreciate the PA-physician partnership. In my 12 years as a PA, I have partnered with more than 50 physicians in cardiology, internal medicine, gastroenterology, and surgical oncology. I have also had the opportunity to witness the dynamic of other PA-physician relationships. As with all relationships, there is a wide range in synergy, productivity, and trust. Some ill-fated relationships are toxic and nonproductive; those merit a swift exit. At the other end of the spectrum are star-crossed partnerships that radiate competence, creativity, and confidence. In between these two extremes are the majority of PA-physician duos, working it out day to day in a kaleidoscopic health care world. It is clear that the physicians and PAs who not only work hard individually, but also work well within their relationship, benefit the most—and so do their patients.
We surgical PAs have a privileged bond that forms at the operating table. It is not only essential, but empowering, to know what each surgeon is thinking about his or her patient as the case unfolds. In medicine, collaboration may not be as intimate as it is in surgery. Still, there is no substitute for knowing our physicians well. Are our treatment goals in sync with theirs? Are we saying the same things to our patients? When we differ (as we often do), how do we achieve respectful and creative dissention? Can we each do our own thing and still be a credible and productive team?
What exactly is PA autonomy? Our scope of practice is delegated by a supervising physician and is limited to the services for which the physician can provide adequate supervision. The terms of supervision vary by state and by practice. In some states, a PA can have multiple “substitute” supervisors, as long as someone keeps a current list. The primary physician supervisor may or may not be the one the PA works with most closely. Some supervisory relationships are merely paper ones, a de rigueur document for the licensing file. Whatever form it takes, supervision has legal and clinical implications that should be implicit to both parties.
If supervision changes drastically, and PA autonomy becomes a reality, the name of our profession would have to change. Physician associate has been proposed. But until we eliminate the word physician, we are still partners with the very profession from which we intend to secede. Certainly, we need to abolish the possessive physician’s (a semantic that rankles universally). Let us get rid of that annoying (and misleading) apostrophe once and for all.
Many of us chose to become PAs to be extenders, rather than bearing ultimate responsibility. That is not to say that we are not willing to make decisions, take risks, or accept liability—that comes with the license and the territory. But in choosing to assist, we have deliberately chosen a dependent role. While physician assistant indeed implies a subordinate relationship, it is not necessarily a subservient one. There is plenty of room for both shared and separate decision-making, for specifically delegated or situational authority. The PA-physician relationship is built on mutual trust that is earned and reinforced on a daily basis. Decisional confidence and technical competence—not wimpy dependence—is the product of a dynamic PA-physician relationship.
As the health care market changes, we can and should afford ourselves every professional opportunity to work as salaried providers or to sign on as single contractors. There are many alternative PA-physician relationships, both legally and financially. If we so desire, we should pursue advanced degrees and specialty certifications and be compensated accordingly. However, multi-tasseled resumes should remain optional. They are costly and not within the reach of everyone, nor do they necessarily make a better PA.
In this new age of autonomy for advanced practice providers, some will say that only a dinosaur could have made these comments. If that is true, thank you for allowing me to wag my tail. The fact remains that PAs offer something unique. In an era of serious physician shortages, we offer patients the opportunity to have both a relationship with their internist, surgeon, or specialist and access to our own capable care and treatment. This is the “package deal” that, sadly, is in danger of becoming overlooked—if not extinct.
PA autonomy is a hot topic lately—not just within the profession but also in the public press. Earlier this year, Forbes touted efforts to loosen “barriers” to PA practice.1 The American Academy of Physician Assistants has identified 10 federal regulations that impose “unnecessary barriers” to medical care provided by PAs; these include cumbersome countersignatures, unnecessary supervision, and ordering restrictions on everything from home care to diabetic shoes.2 Lifting these barriers makes sense amid a shortage of physicians and an influx of newly insured patients (for more on this topic, see here). But as we acquire greater autonomy, we must not lose sight of the relationship that our profession was founded on—and that makes it unique.
Many PAs aspire to be truly independent practitioners, and some already are (eg, in remote and rural areas). Those of us who practice more closely with physicians may be more apt to appreciate the PA-physician partnership. In my 12 years as a PA, I have partnered with more than 50 physicians in cardiology, internal medicine, gastroenterology, and surgical oncology. I have also had the opportunity to witness the dynamic of other PA-physician relationships. As with all relationships, there is a wide range in synergy, productivity, and trust. Some ill-fated relationships are toxic and nonproductive; those merit a swift exit. At the other end of the spectrum are star-crossed partnerships that radiate competence, creativity, and confidence. In between these two extremes are the majority of PA-physician duos, working it out day to day in a kaleidoscopic health care world. It is clear that the physicians and PAs who not only work hard individually, but also work well within their relationship, benefit the most—and so do their patients.
We surgical PAs have a privileged bond that forms at the operating table. It is not only essential, but empowering, to know what each surgeon is thinking about his or her patient as the case unfolds. In medicine, collaboration may not be as intimate as it is in surgery. Still, there is no substitute for knowing our physicians well. Are our treatment goals in sync with theirs? Are we saying the same things to our patients? When we differ (as we often do), how do we achieve respectful and creative dissention? Can we each do our own thing and still be a credible and productive team?
What exactly is PA autonomy? Our scope of practice is delegated by a supervising physician and is limited to the services for which the physician can provide adequate supervision. The terms of supervision vary by state and by practice. In some states, a PA can have multiple “substitute” supervisors, as long as someone keeps a current list. The primary physician supervisor may or may not be the one the PA works with most closely. Some supervisory relationships are merely paper ones, a de rigueur document for the licensing file. Whatever form it takes, supervision has legal and clinical implications that should be implicit to both parties.
If supervision changes drastically, and PA autonomy becomes a reality, the name of our profession would have to change. Physician associate has been proposed. But until we eliminate the word physician, we are still partners with the very profession from which we intend to secede. Certainly, we need to abolish the possessive physician’s (a semantic that rankles universally). Let us get rid of that annoying (and misleading) apostrophe once and for all.
Many of us chose to become PAs to be extenders, rather than bearing ultimate responsibility. That is not to say that we are not willing to make decisions, take risks, or accept liability—that comes with the license and the territory. But in choosing to assist, we have deliberately chosen a dependent role. While physician assistant indeed implies a subordinate relationship, it is not necessarily a subservient one. There is plenty of room for both shared and separate decision-making, for specifically delegated or situational authority. The PA-physician relationship is built on mutual trust that is earned and reinforced on a daily basis. Decisional confidence and technical competence—not wimpy dependence—is the product of a dynamic PA-physician relationship.
As the health care market changes, we can and should afford ourselves every professional opportunity to work as salaried providers or to sign on as single contractors. There are many alternative PA-physician relationships, both legally and financially. If we so desire, we should pursue advanced degrees and specialty certifications and be compensated accordingly. However, multi-tasseled resumes should remain optional. They are costly and not within the reach of everyone, nor do they necessarily make a better PA.
In this new age of autonomy for advanced practice providers, some will say that only a dinosaur could have made these comments. If that is true, thank you for allowing me to wag my tail. The fact remains that PAs offer something unique. In an era of serious physician shortages, we offer patients the opportunity to have both a relationship with their internist, surgeon, or specialist and access to our own capable care and treatment. This is the “package deal” that, sadly, is in danger of becoming overlooked—if not extinct.
1. Japsen B. States remove barriers to physician assistants . Forbes. March 6, 2016. www.forbes.com/sites/brucejapsen/2016/03/06/states-remove-barriers-to-physician-assistants. Accessed September 13, 2016.
2. American Academy of Physician Assistants. Top ten federal laws & regulations imposing unnecessary barriers to medical care provided by PAs. www.aapa.org/workarea/downloadasset.aspx?id=6442450999. Accessed September 13, 2016.
1. Japsen B. States remove barriers to physician assistants . Forbes. March 6, 2016. www.forbes.com/sites/brucejapsen/2016/03/06/states-remove-barriers-to-physician-assistants. Accessed September 13, 2016.
2. American Academy of Physician Assistants. Top ten federal laws & regulations imposing unnecessary barriers to medical care provided by PAs. www.aapa.org/workarea/downloadasset.aspx?id=6442450999. Accessed September 13, 2016.
Why placental shape and vasculature matter
The intrauterine environment significantly influences not only fetal and infant health, but adult health risks as well. Yet current efforts in obstetrics to assess the environment and optimize fetal and long-term outcomes are based on diagnostics that focus on and measure fetal signs and symptoms. By and large, the current approach overlooks the placenta – the organ that serves as the principal regulator of fetal growth and health. If the fetus appears free of risk or complications, we assume the placenta must be “okay.”
Yet this isn’t always the case. By assuming the placenta is healthy and not observing and measuring its condition, we are too often too late to effectively alter fetal- and longer-term outcomes once fetal signs and symptoms appear.
Research in recent decades, and particularly in the past 10 years, has demonstrated that placental shape matters, that it’s linked to function, and that quantifying abnormalities in shape and growth can be a meaningful clinical tool for detecting and preventing disease early in pregnancy.
We now know, specifically, that abnormal shapes reflect alterations in placental vascular architecture that lead to reduced placental efficiency. We also now understand that placental weight or size may serve as a proxy for fetoplacental metabolism.
We have more research to do to further develop models, to collect more data, and to more fully understand the placental pathology that precedes detectable fetal and/or maternal disease. We also need to know whether the early detection of placental disease has sufficient positive predictive value to allow for safe and effective intervention.1
The National Institutes of Health is investing more than $40 million in its Human Placenta Project, which aims to develop new technologies to help researchers monitor the placenta in real time. Yet it is possible that the use of ultrasound and Doppler – technologies that we employ routinely and know are safe – may go a long way toward deepening our knowledge that will, in turn, hone our ability to identify early risks.
When I speak to fellow pathologists, my message is, “Let’s stop wasting data.” For ob.gyns., my message is twofold: First, appreciate the potential to predict and alter downstream fetal and/or maternal risks by observing and measuring the placenta. Second, be aware of the value of early in vivo placental images, as well as photographs, and more precise measures of delivered placentas.
Why shape matters
The “average” or “typical” placental shape is round or oval with a centrally inserted umbilical cord. In practice, we see a variety of surface shapes and cord insertion sites, with common variations such as bi- or multi-lobate shapes, or otherwise irregular shapes and cord insertions that are eccentric, marginal, or velamentous. Interestingly, many irregularly shaped placentas display symmetry and have regular, defined geometrical patterns, like snowflakes.2
We have long understood that the microscopic growth of the human placenta involves repeated vascular branching analogous to the roots of a tree. This vascular development, or “placental arborization,” reflects the health of the maternal environment and impacts fetal health.
It is only in recent years, however, that we’ve gained a much better understanding of the relationship of the vascular structure and the shape of the placenta, and an understanding of how early changes in the branching structure of the placenta’s vascular tree drive variation in mature placental shape.
By applying a well-accepted mathematical model for generating highly branched fractals (a model for random growth known in the mathematical physics world as diffusion limited aggregation, or DLA), we have reliably reproduced the variability in placental shapes and related these shapes to the structure of the underlying vascular tree.
When the model is run with unperturbed, random values of a branching growth parameter, we get round-oval fractal shapes. But when the growth parameter is perturbed at a single point in time – when a one-time, early change is introduced – arborization is negatively affected and we get irregular shapes.
The model’s output has explained and verified a clinically observed association between non-round, non-oval placental shapes and smaller newborn birth weight for given placental weight.
This association was evident in an analysis of data collected as part of the National Collaborative Perinatal Project (1959-1974), which included placental measures such as weight, shape, size, and thickness for more than 24,000 women. It also was apparent in an analysis of data and images collected as part of the Pregnancy, Infection, and Nutrition (PIN) Study, conducted in North Carolina.
One take-away from both of these studies has been that increased variability of placental shape is associated with lower placental functional efficiency. Moreover, in the University of North Carolina cohort, the impact of placental vascular pathology (either maternal uteroplacental or fetoplacental) on placental efficiency and function was shown to be dependent on shape. Only in the case of irregularly shaped chorionic plates did each of the two pathologies have a significant association with placental inefficiency.3
The realization that placental size (weight/mass/volume) may serve as a proxy for the fetoplacental basal metabolic rate came after it was shown that Kleiber’s law, which states that basal metabolic rate (BMR) is proportional to the body mass to the 3/4 power, can be applied to the newborn’s birth weight by substituting placental weight for BMR.
This fetal-placental version (placenta weight = .75 birth weight) of Kleiber’s law was validated through an analysis of the sets of placental measures and birth weights stored in the Collaborative Perinatal Project. It has implications for our ability to use ultrasound and Doppler measures to predict risk and to understand pathologic pregnancies, such as those complicated by diabetes or fetal growth restriction.
Research also has shed light on the timing of shape variants. We now know that abnormalities of placental surface shape result mainly from early influences – perturbations of placental growth that occur no later than mid-gestation – rather than from trophotropism (the placenta “grows where it can and does not grow where it can’t”) and passive uterine remodeling later in pregnancy, as has traditionally been believed.4
With respect to the umbilical cord, the location of cord insertion is independent of eventual disk shape, but is to a large degree determined by the end of the first trimester. In addition, cord insertion does influence and is correlated with chorionic vascular density and with disk thickness. Greater eccentricity of cord insertion appears to be linked to increased placental disk thickness, each of which is independently associated with reduced placental functional efficiency.5,6
We have worked with placentas from newborns in families with an older child diagnosed with autism and have found significant differences between these placentas and the placentas of low-risk newborns. In particular, we have measured a reduction in the number or chorionic surface vessel branch points of more than 40%.
Current implications
Irregularities in placental surface shape, disk thickness, and various descriptors of placental size may all be determined from ultrasound and Doppler imaging. We can also assess cord insertion and chorionic surface vessel distribution, track patterns and rates of placental growth, and use various placental measures to understand placental efficiency and to improve the specificity of placental histopathologic diagnoses.
At this point, our use of in vivo imaging of the placenta has mainly involved grayscale ultrasound, but with color or power Doppler and improved surface network tracing protocols, we could save the red and blue areas we visualize as a “shape” and assess the density of surface vessel branching, for instance, and the degree of uniformity in vessel distribution.
We currently have quantitative markers of placental shape and mathematical models to help us identify at-risk pregnancies. What we need are more data from early ultrasounds (from all pregnancies and not only complicated ones) and more comprehensive and precise models of placental growth and function. This will enable us to better identify preclinical fetoplacental pathophysiology and predict downstream risks.
In the meantime, the delivered placenta can be a valuable source of information – an extra dimension for looking back in time. With a paradigm shift toward more thorough pathologic analysis, the delivered placenta can provide unique insights into how placental growth evolved during the pregnancy.
Do not throw away the placenta, and do not just weigh it. Take a photograph, because even with a photograph we can assess vascular density, disk thickness, and other placental characteristics.
In the case of pregnancy complications or suboptimal outcomes, the knowledge we can gain from the delivered placenta can help the physician and patient to understand recurrence risks and to better target evaluation, monitoring, and management in the next pregnancy.
References
1. Am J Perinatol. 2016 Aug 4. doi: 10.1055/s-0036-1586508.
2. Placenta. 2008 Sep;29(9):790-7.
3. Placenta. 2010 Nov;31(11):958-62.
4. Placenta. 2012 Mar;33(3):164-70.
5. J Dev Orig Health Dis. 2011 Aug;2(4):205-11.
6. Placenta. 2009 Dec;30(12):1058-64.
Dr. Salafia leads the Placental Modulation Laboratory at New York State’s Institute for Basic Research in Developmental Disabilities, Staten Island, N.Y. She reported that she has no relevant financial disclosures.
The intrauterine environment significantly influences not only fetal and infant health, but adult health risks as well. Yet current efforts in obstetrics to assess the environment and optimize fetal and long-term outcomes are based on diagnostics that focus on and measure fetal signs and symptoms. By and large, the current approach overlooks the placenta – the organ that serves as the principal regulator of fetal growth and health. If the fetus appears free of risk or complications, we assume the placenta must be “okay.”
Yet this isn’t always the case. By assuming the placenta is healthy and not observing and measuring its condition, we are too often too late to effectively alter fetal- and longer-term outcomes once fetal signs and symptoms appear.
Research in recent decades, and particularly in the past 10 years, has demonstrated that placental shape matters, that it’s linked to function, and that quantifying abnormalities in shape and growth can be a meaningful clinical tool for detecting and preventing disease early in pregnancy.
We now know, specifically, that abnormal shapes reflect alterations in placental vascular architecture that lead to reduced placental efficiency. We also now understand that placental weight or size may serve as a proxy for fetoplacental metabolism.
We have more research to do to further develop models, to collect more data, and to more fully understand the placental pathology that precedes detectable fetal and/or maternal disease. We also need to know whether the early detection of placental disease has sufficient positive predictive value to allow for safe and effective intervention.1
The National Institutes of Health is investing more than $40 million in its Human Placenta Project, which aims to develop new technologies to help researchers monitor the placenta in real time. Yet it is possible that the use of ultrasound and Doppler – technologies that we employ routinely and know are safe – may go a long way toward deepening our knowledge that will, in turn, hone our ability to identify early risks.
When I speak to fellow pathologists, my message is, “Let’s stop wasting data.” For ob.gyns., my message is twofold: First, appreciate the potential to predict and alter downstream fetal and/or maternal risks by observing and measuring the placenta. Second, be aware of the value of early in vivo placental images, as well as photographs, and more precise measures of delivered placentas.
Why shape matters
The “average” or “typical” placental shape is round or oval with a centrally inserted umbilical cord. In practice, we see a variety of surface shapes and cord insertion sites, with common variations such as bi- or multi-lobate shapes, or otherwise irregular shapes and cord insertions that are eccentric, marginal, or velamentous. Interestingly, many irregularly shaped placentas display symmetry and have regular, defined geometrical patterns, like snowflakes.2
We have long understood that the microscopic growth of the human placenta involves repeated vascular branching analogous to the roots of a tree. This vascular development, or “placental arborization,” reflects the health of the maternal environment and impacts fetal health.
It is only in recent years, however, that we’ve gained a much better understanding of the relationship of the vascular structure and the shape of the placenta, and an understanding of how early changes in the branching structure of the placenta’s vascular tree drive variation in mature placental shape.
By applying a well-accepted mathematical model for generating highly branched fractals (a model for random growth known in the mathematical physics world as diffusion limited aggregation, or DLA), we have reliably reproduced the variability in placental shapes and related these shapes to the structure of the underlying vascular tree.
When the model is run with unperturbed, random values of a branching growth parameter, we get round-oval fractal shapes. But when the growth parameter is perturbed at a single point in time – when a one-time, early change is introduced – arborization is negatively affected and we get irregular shapes.
The model’s output has explained and verified a clinically observed association between non-round, non-oval placental shapes and smaller newborn birth weight for given placental weight.
This association was evident in an analysis of data collected as part of the National Collaborative Perinatal Project (1959-1974), which included placental measures such as weight, shape, size, and thickness for more than 24,000 women. It also was apparent in an analysis of data and images collected as part of the Pregnancy, Infection, and Nutrition (PIN) Study, conducted in North Carolina.
One take-away from both of these studies has been that increased variability of placental shape is associated with lower placental functional efficiency. Moreover, in the University of North Carolina cohort, the impact of placental vascular pathology (either maternal uteroplacental or fetoplacental) on placental efficiency and function was shown to be dependent on shape. Only in the case of irregularly shaped chorionic plates did each of the two pathologies have a significant association with placental inefficiency.3
The realization that placental size (weight/mass/volume) may serve as a proxy for the fetoplacental basal metabolic rate came after it was shown that Kleiber’s law, which states that basal metabolic rate (BMR) is proportional to the body mass to the 3/4 power, can be applied to the newborn’s birth weight by substituting placental weight for BMR.
This fetal-placental version (placenta weight = .75 birth weight) of Kleiber’s law was validated through an analysis of the sets of placental measures and birth weights stored in the Collaborative Perinatal Project. It has implications for our ability to use ultrasound and Doppler measures to predict risk and to understand pathologic pregnancies, such as those complicated by diabetes or fetal growth restriction.
Research also has shed light on the timing of shape variants. We now know that abnormalities of placental surface shape result mainly from early influences – perturbations of placental growth that occur no later than mid-gestation – rather than from trophotropism (the placenta “grows where it can and does not grow where it can’t”) and passive uterine remodeling later in pregnancy, as has traditionally been believed.4
With respect to the umbilical cord, the location of cord insertion is independent of eventual disk shape, but is to a large degree determined by the end of the first trimester. In addition, cord insertion does influence and is correlated with chorionic vascular density and with disk thickness. Greater eccentricity of cord insertion appears to be linked to increased placental disk thickness, each of which is independently associated with reduced placental functional efficiency.5,6
We have worked with placentas from newborns in families with an older child diagnosed with autism and have found significant differences between these placentas and the placentas of low-risk newborns. In particular, we have measured a reduction in the number or chorionic surface vessel branch points of more than 40%.
Current implications
Irregularities in placental surface shape, disk thickness, and various descriptors of placental size may all be determined from ultrasound and Doppler imaging. We can also assess cord insertion and chorionic surface vessel distribution, track patterns and rates of placental growth, and use various placental measures to understand placental efficiency and to improve the specificity of placental histopathologic diagnoses.
At this point, our use of in vivo imaging of the placenta has mainly involved grayscale ultrasound, but with color or power Doppler and improved surface network tracing protocols, we could save the red and blue areas we visualize as a “shape” and assess the density of surface vessel branching, for instance, and the degree of uniformity in vessel distribution.
We currently have quantitative markers of placental shape and mathematical models to help us identify at-risk pregnancies. What we need are more data from early ultrasounds (from all pregnancies and not only complicated ones) and more comprehensive and precise models of placental growth and function. This will enable us to better identify preclinical fetoplacental pathophysiology and predict downstream risks.
In the meantime, the delivered placenta can be a valuable source of information – an extra dimension for looking back in time. With a paradigm shift toward more thorough pathologic analysis, the delivered placenta can provide unique insights into how placental growth evolved during the pregnancy.
Do not throw away the placenta, and do not just weigh it. Take a photograph, because even with a photograph we can assess vascular density, disk thickness, and other placental characteristics.
In the case of pregnancy complications or suboptimal outcomes, the knowledge we can gain from the delivered placenta can help the physician and patient to understand recurrence risks and to better target evaluation, monitoring, and management in the next pregnancy.
References
1. Am J Perinatol. 2016 Aug 4. doi: 10.1055/s-0036-1586508.
2. Placenta. 2008 Sep;29(9):790-7.
3. Placenta. 2010 Nov;31(11):958-62.
4. Placenta. 2012 Mar;33(3):164-70.
5. J Dev Orig Health Dis. 2011 Aug;2(4):205-11.
6. Placenta. 2009 Dec;30(12):1058-64.
Dr. Salafia leads the Placental Modulation Laboratory at New York State’s Institute for Basic Research in Developmental Disabilities, Staten Island, N.Y. She reported that she has no relevant financial disclosures.
The intrauterine environment significantly influences not only fetal and infant health, but adult health risks as well. Yet current efforts in obstetrics to assess the environment and optimize fetal and long-term outcomes are based on diagnostics that focus on and measure fetal signs and symptoms. By and large, the current approach overlooks the placenta – the organ that serves as the principal regulator of fetal growth and health. If the fetus appears free of risk or complications, we assume the placenta must be “okay.”
Yet this isn’t always the case. By assuming the placenta is healthy and not observing and measuring its condition, we are too often too late to effectively alter fetal- and longer-term outcomes once fetal signs and symptoms appear.
Research in recent decades, and particularly in the past 10 years, has demonstrated that placental shape matters, that it’s linked to function, and that quantifying abnormalities in shape and growth can be a meaningful clinical tool for detecting and preventing disease early in pregnancy.
We now know, specifically, that abnormal shapes reflect alterations in placental vascular architecture that lead to reduced placental efficiency. We also now understand that placental weight or size may serve as a proxy for fetoplacental metabolism.
We have more research to do to further develop models, to collect more data, and to more fully understand the placental pathology that precedes detectable fetal and/or maternal disease. We also need to know whether the early detection of placental disease has sufficient positive predictive value to allow for safe and effective intervention.1
The National Institutes of Health is investing more than $40 million in its Human Placenta Project, which aims to develop new technologies to help researchers monitor the placenta in real time. Yet it is possible that the use of ultrasound and Doppler – technologies that we employ routinely and know are safe – may go a long way toward deepening our knowledge that will, in turn, hone our ability to identify early risks.
When I speak to fellow pathologists, my message is, “Let’s stop wasting data.” For ob.gyns., my message is twofold: First, appreciate the potential to predict and alter downstream fetal and/or maternal risks by observing and measuring the placenta. Second, be aware of the value of early in vivo placental images, as well as photographs, and more precise measures of delivered placentas.
Why shape matters
The “average” or “typical” placental shape is round or oval with a centrally inserted umbilical cord. In practice, we see a variety of surface shapes and cord insertion sites, with common variations such as bi- or multi-lobate shapes, or otherwise irregular shapes and cord insertions that are eccentric, marginal, or velamentous. Interestingly, many irregularly shaped placentas display symmetry and have regular, defined geometrical patterns, like snowflakes.2
We have long understood that the microscopic growth of the human placenta involves repeated vascular branching analogous to the roots of a tree. This vascular development, or “placental arborization,” reflects the health of the maternal environment and impacts fetal health.
It is only in recent years, however, that we’ve gained a much better understanding of the relationship of the vascular structure and the shape of the placenta, and an understanding of how early changes in the branching structure of the placenta’s vascular tree drive variation in mature placental shape.
By applying a well-accepted mathematical model for generating highly branched fractals (a model for random growth known in the mathematical physics world as diffusion limited aggregation, or DLA), we have reliably reproduced the variability in placental shapes and related these shapes to the structure of the underlying vascular tree.
When the model is run with unperturbed, random values of a branching growth parameter, we get round-oval fractal shapes. But when the growth parameter is perturbed at a single point in time – when a one-time, early change is introduced – arborization is negatively affected and we get irregular shapes.
The model’s output has explained and verified a clinically observed association between non-round, non-oval placental shapes and smaller newborn birth weight for given placental weight.
This association was evident in an analysis of data collected as part of the National Collaborative Perinatal Project (1959-1974), which included placental measures such as weight, shape, size, and thickness for more than 24,000 women. It also was apparent in an analysis of data and images collected as part of the Pregnancy, Infection, and Nutrition (PIN) Study, conducted in North Carolina.
One take-away from both of these studies has been that increased variability of placental shape is associated with lower placental functional efficiency. Moreover, in the University of North Carolina cohort, the impact of placental vascular pathology (either maternal uteroplacental or fetoplacental) on placental efficiency and function was shown to be dependent on shape. Only in the case of irregularly shaped chorionic plates did each of the two pathologies have a significant association with placental inefficiency.3
The realization that placental size (weight/mass/volume) may serve as a proxy for the fetoplacental basal metabolic rate came after it was shown that Kleiber’s law, which states that basal metabolic rate (BMR) is proportional to the body mass to the 3/4 power, can be applied to the newborn’s birth weight by substituting placental weight for BMR.
This fetal-placental version (placenta weight = .75 birth weight) of Kleiber’s law was validated through an analysis of the sets of placental measures and birth weights stored in the Collaborative Perinatal Project. It has implications for our ability to use ultrasound and Doppler measures to predict risk and to understand pathologic pregnancies, such as those complicated by diabetes or fetal growth restriction.
Research also has shed light on the timing of shape variants. We now know that abnormalities of placental surface shape result mainly from early influences – perturbations of placental growth that occur no later than mid-gestation – rather than from trophotropism (the placenta “grows where it can and does not grow where it can’t”) and passive uterine remodeling later in pregnancy, as has traditionally been believed.4
With respect to the umbilical cord, the location of cord insertion is independent of eventual disk shape, but is to a large degree determined by the end of the first trimester. In addition, cord insertion does influence and is correlated with chorionic vascular density and with disk thickness. Greater eccentricity of cord insertion appears to be linked to increased placental disk thickness, each of which is independently associated with reduced placental functional efficiency.5,6
We have worked with placentas from newborns in families with an older child diagnosed with autism and have found significant differences between these placentas and the placentas of low-risk newborns. In particular, we have measured a reduction in the number or chorionic surface vessel branch points of more than 40%.
Current implications
Irregularities in placental surface shape, disk thickness, and various descriptors of placental size may all be determined from ultrasound and Doppler imaging. We can also assess cord insertion and chorionic surface vessel distribution, track patterns and rates of placental growth, and use various placental measures to understand placental efficiency and to improve the specificity of placental histopathologic diagnoses.
At this point, our use of in vivo imaging of the placenta has mainly involved grayscale ultrasound, but with color or power Doppler and improved surface network tracing protocols, we could save the red and blue areas we visualize as a “shape” and assess the density of surface vessel branching, for instance, and the degree of uniformity in vessel distribution.
We currently have quantitative markers of placental shape and mathematical models to help us identify at-risk pregnancies. What we need are more data from early ultrasounds (from all pregnancies and not only complicated ones) and more comprehensive and precise models of placental growth and function. This will enable us to better identify preclinical fetoplacental pathophysiology and predict downstream risks.
In the meantime, the delivered placenta can be a valuable source of information – an extra dimension for looking back in time. With a paradigm shift toward more thorough pathologic analysis, the delivered placenta can provide unique insights into how placental growth evolved during the pregnancy.
Do not throw away the placenta, and do not just weigh it. Take a photograph, because even with a photograph we can assess vascular density, disk thickness, and other placental characteristics.
In the case of pregnancy complications or suboptimal outcomes, the knowledge we can gain from the delivered placenta can help the physician and patient to understand recurrence risks and to better target evaluation, monitoring, and management in the next pregnancy.
References
1. Am J Perinatol. 2016 Aug 4. doi: 10.1055/s-0036-1586508.
2. Placenta. 2008 Sep;29(9):790-7.
3. Placenta. 2010 Nov;31(11):958-62.
4. Placenta. 2012 Mar;33(3):164-70.
5. J Dev Orig Health Dis. 2011 Aug;2(4):205-11.
6. Placenta. 2009 Dec;30(12):1058-64.
Dr. Salafia leads the Placental Modulation Laboratory at New York State’s Institute for Basic Research in Developmental Disabilities, Staten Island, N.Y. She reported that she has no relevant financial disclosures.
Compete and Solve Clinical Cases with Human Diagnosis Project
SHM recently partnered with the Human Diagnosis Project. Human Dx is the world’s first open diagnostic system, which aims to understand the fundamental data structure of diagnosis and, in the future, considerably impact the cost of, access to, and effectiveness of healthcare globally.
Human Dx’s Global Morning Reports feature weekly case competitions of differential diagnoses and clinical reasoning skills. Each day, attendings, fellows, residents, and medical students have the opportunity to solve the best cases from around the world from the prior day and submit cases for the next day. This partnership with SHM provides a unique, interactive learning platform with cases tailored to hospitalists.
The rules are simple:
- Increase your “Impact” by creating and solving cases online.
- Creating cases creates more “Impact” than solving cases.
The team and individual with the most “Impact” each week win. Sign up today and test your skills in hospital medicine diagnostics at www.humandx.org/shm/.
SHM recently partnered with the Human Diagnosis Project. Human Dx is the world’s first open diagnostic system, which aims to understand the fundamental data structure of diagnosis and, in the future, considerably impact the cost of, access to, and effectiveness of healthcare globally.
Human Dx’s Global Morning Reports feature weekly case competitions of differential diagnoses and clinical reasoning skills. Each day, attendings, fellows, residents, and medical students have the opportunity to solve the best cases from around the world from the prior day and submit cases for the next day. This partnership with SHM provides a unique, interactive learning platform with cases tailored to hospitalists.
The rules are simple:
- Increase your “Impact” by creating and solving cases online.
- Creating cases creates more “Impact” than solving cases.
The team and individual with the most “Impact” each week win. Sign up today and test your skills in hospital medicine diagnostics at www.humandx.org/shm/.
SHM recently partnered with the Human Diagnosis Project. Human Dx is the world’s first open diagnostic system, which aims to understand the fundamental data structure of diagnosis and, in the future, considerably impact the cost of, access to, and effectiveness of healthcare globally.
Human Dx’s Global Morning Reports feature weekly case competitions of differential diagnoses and clinical reasoning skills. Each day, attendings, fellows, residents, and medical students have the opportunity to solve the best cases from around the world from the prior day and submit cases for the next day. This partnership with SHM provides a unique, interactive learning platform with cases tailored to hospitalists.
The rules are simple:
- Increase your “Impact” by creating and solving cases online.
- Creating cases creates more “Impact” than solving cases.
The team and individual with the most “Impact” each week win. Sign up today and test your skills in hospital medicine diagnostics at www.humandx.org/shm/.