Karen Roush, PhD, RN

Study Overview

Objective. To understand how the experience of intimate partner violence and non-partner sexual assault (IPV/SA) in women in the military intersects with military service.

Design. Qualitative interviews conducted as part of a larger study focused on experiences of IPV/SA and health care needs and preferences among women veteran patients.

Setting and participants. Participants were 25 women veterans from all branches of the service, ages 22 to 58 years (mean 44.6), who were patients at the Veteran’s Medical Center in Philadelphia, PA. The sample was diverse: 56% self-identified as black or African American, 20% as white or Caucasian, 16% as Hispanic or Latina, and 8% as “other” or multiple race/ethnicity.

Interviews. Researchers conducted face-to-face interviews using a semi-structured interview guide to gather in-depth narratives related to the participants’ lives in the military and their experiences of IPV/SA. The Military Occupational Mental Health Model was used as a framework to understand the experience of IPV/SA within the cultural context of the military and how that context influences health and well-being. The model considers the unique context of the military, including the importance of the values of mission over individual well-being, hierarchy and subordination, leadership, and unit support, as well as what resources are made available.

Data analysis. The authors followed an inductive approach informed by grounded theory, with the goal of identifying themes and a unifying theory empirically grounded in the interview data. First, 2 members of the research team conducted independent, close readings of each transcript and applied open coding, then compared their coding to identify common patterns across transcripts. Through this process, they developed and refined a codebook to define a set of codes and guide application of codes to text. Research team members conducted line-by-line coding of each transcript, based on the codebook definitions. Then the authors read all coded text and met to discuss patterns within and between transcripts, leading to identification of 2 core categories pertaining to the relationship betweenIPV/SA and military service, as well as several subthemes within each core category.

Main results. The 2 core categories identified  had both positive and negative influences. The first was  the “experience of IPV/SA affects participation in military service, including entering and leaving military service,” and included the subthemes of coercion by the perpetrator to enter or leave military service, effects on service and work performance such as physical and mental health problems that interfered with their ability to do their job, and survival strategies that had negative repercussions on the woman’s career. The second was  the “military context shapes responses to, and coping with, experiences of IPV/SA,” and included the subthemes of military sanction for IPV (but not sexual assault) if both partners were in the military, lack of accountability for and protection of service member perpetrators due to the value of unit support, military service as an opportunity to escape through relocation, even preferring a combat zone over home, and resistance to seeking help because of expectations of invulnerability related to the warrior identity.

Conclusion. The military context can provide personal and occupational resources for women who experience IPV/SA, but the institutional (ie, chain of command reporting) and cultural context can constrain women’s ability to access resources and support, negatively affecting outcomes.

Commentary

Intimate partner violence (IPV) is a widespread public health problem in the United States and women in the military are no exception. According to Black and Merrick [1], 36.3% of active duty women experienced sexual violence in their lifetime and 39.7% experienced IPV. Violence has significant health, economic, and social consequences for women in all settings, including serious short- and long-term physical and mental health problems, economic hardship, isolation, and decreased quality of life [2–5]. Women who experience IPV/SA in any setting face challenges in protecting themselves, overcoming violence, and seeking justice, however, the context in which the violence occurs can significantly influence the individual experiences of women. This study used a qualitative approach to understand how it is experienced by service women in the context of the military.

As the authors note, military culture can both facilitate and hamper women’s recovery from the physical, psychological, and economic sequelae of IPV/SA. The rigid hierarchal structure of the military and the expectation that one supports the unit and fellow soldiers above all else makes it very difficult for women to disclose IPV/SA and seek and receive protection and justice. On the other hand, military training and service provides women with the skills and means to be independent and to physically distance themselves from the perpetrator. However, the comment of one woman that facing bombs in Iraq was preferable to facing the violence at home should serve as a reminder of how devastating IPV/SA is and suggests that victims do not think there are effective institutional deterrents or protection available to them.

As the authors note, this was a small convenience sample of women at one VA medical center. This qualitative study provides a beginning understanding that should be expanded on with multisite quantitative research with large samples. Sexual assault in the military has been recognized as a significant problem, particularly for women but also for men. We need to continue to study this problem from many different perspectives to determine how to prevent violence and to ensure all victims get the resources and effective services they need.

Applications for Clinical Practice

This study has implications for all health care providers, as active duty and veteran service women seek care outside as well as within the VA. An important finding that has direct application to practice in all settings is the influence of the warrior identity. The warrior identity has been widely acknowledged as a barrier to seeking help for depression or PTSD in service men returning from combat but not as much in service women and not in the context of IPV/SA. It is important that providers consider warrior identity in assessing and treating women for IPV/SA. Not only can this affect disclosure and prevent a victim from seeking help, but the expectation that they should have been invulnerable and strong may increase feelings of self-blame and worsen psychological distress.

 —Karen Roush, PhD, RN

Study Overview

Objective. To understand how the experience of intimate partner violence and non-partner sexual assault (IPV/SA) in women in the military intersects with military service.

Design. Qualitative interviews conducted as part of a larger study focused on experiences of IPV/SA and health care needs and preferences among women veteran patients.

Setting and participants. Participants were 25 women veterans from all branches of the service, ages 22 to 58 years (mean 44.6), who were patients at the Veteran’s Medical Center in Philadelphia, PA. The sample was diverse: 56% self-identified as black or African American, 20% as white or Caucasian, 16% as Hispanic or Latina, and 8% as “other” or multiple race/ethnicity.

Interviews. Researchers conducted face-to-face interviews using a semi-structured interview guide to gather in-depth narratives related to the participants’ lives in the military and their experiences of IPV/SA. The Military Occupational Mental Health Model was used as a framework to understand the experience of IPV/SA within the cultural context of the military and how that context influences health and well-being. The model considers the unique context of the military, including the importance of the values of mission over individual well-being, hierarchy and subordination, leadership, and unit support, as well as what resources are made available.

Data analysis. The authors followed an inductive approach informed by grounded theory, with the goal of identifying themes and a unifying theory empirically grounded in the interview data. First, 2 members of the research team conducted independent, close readings of each transcript and applied open coding, then compared their coding to identify common patterns across transcripts. Through this process, they developed and refined a codebook to define a set of codes and guide application of codes to text. Research team members conducted line-by-line coding of each transcript, based on the codebook definitions. Then the authors read all coded text and met to discuss patterns within and between transcripts, leading to identification of 2 core categories pertaining to the relationship betweenIPV/SA and military service, as well as several subthemes within each core category.

Main results. The 2 core categories identified  had both positive and negative influences. The first was  the “experience of IPV/SA affects participation in military service, including entering and leaving military service,” and included the subthemes of coercion by the perpetrator to enter or leave military service, effects on service and work performance such as physical and mental health problems that interfered with their ability to do their job, and survival strategies that had negative repercussions on the woman’s career. The second was  the “military context shapes responses to, and coping with, experiences of IPV/SA,” and included the subthemes of military sanction for IPV (but not sexual assault) if both partners were in the military, lack of accountability for and protection of service member perpetrators due to the value of unit support, military service as an opportunity to escape through relocation, even preferring a combat zone over home, and resistance to seeking help because of expectations of invulnerability related to the warrior identity.

Conclusion. The military context can provide personal and occupational resources for women who experience IPV/SA, but the institutional (ie, chain of command reporting) and cultural context can constrain women’s ability to access resources and support, negatively affecting outcomes.

Commentary

Intimate partner violence (IPV) is a widespread public health problem in the United States and women in the military are no exception. According to Black and Merrick [1], 36.3% of active duty women experienced sexual violence in their lifetime and 39.7% experienced IPV. Violence has significant health, economic, and social consequences for women in all settings, including serious short- and long-term physical and mental health problems, economic hardship, isolation, and decreased quality of life [2–5]. Women who experience IPV/SA in any setting face challenges in protecting themselves, overcoming violence, and seeking justice, however, the context in which the violence occurs can significantly influence the individual experiences of women. This study used a qualitative approach to understand how it is experienced by service women in the context of the military.

As the authors note, military culture can both facilitate and hamper women’s recovery from the physical, psychological, and economic sequelae of IPV/SA. The rigid hierarchal structure of the military and the expectation that one supports the unit and fellow soldiers above all else makes it very difficult for women to disclose IPV/SA and seek and receive protection and justice. On the other hand, military training and service provides women with the skills and means to be independent and to physically distance themselves from the perpetrator. However, the comment of one woman that facing bombs in Iraq was preferable to facing the violence at home should serve as a reminder of how devastating IPV/SA is and suggests that victims do not think there are effective institutional deterrents or protection available to them.

As the authors note, this was a small convenience sample of women at one VA medical center. This qualitative study provides a beginning understanding that should be expanded on with multisite quantitative research with large samples. Sexual assault in the military has been recognized as a significant problem, particularly for women but also for men. We need to continue to study this problem from many different perspectives to determine how to prevent violence and to ensure all victims get the resources and effective services they need.

Applications for Clinical Practice

This study has implications for all health care providers, as active duty and veteran service women seek care outside as well as within the VA. An important finding that has direct application to practice in all settings is the influence of the warrior identity. The warrior identity has been widely acknowledged as a barrier to seeking help for depression or PTSD in service men returning from combat but not as much in service women and not in the context of IPV/SA. It is important that providers consider warrior identity in assessing and treating women for IPV/SA. Not only can this affect disclosure and prevent a victim from seeking help, but the expectation that they should have been invulnerable and strong may increase feelings of self-blame and worsen psychological distress.

 —Karen Roush, PhD, RN

Study Overview

Objective. To understand how the experience of intimate partner violence and non-partner sexual assault (IPV/SA) in women in the military intersects with military service.

Design. Qualitative interviews conducted as part of a larger study focused on experiences of IPV/SA and health care needs and preferences among women veteran patients.

Setting and participants. Participants were 25 women veterans from all branches of the service, ages 22 to 58 years (mean 44.6), who were patients at the Veteran’s Medical Center in Philadelphia, PA. The sample was diverse: 56% self-identified as black or African American, 20% as white or Caucasian, 16% as Hispanic or Latina, and 8% as “other” or multiple race/ethnicity.

Interviews. Researchers conducted face-to-face interviews using a semi-structured interview guide to gather in-depth narratives related to the participants’ lives in the military and their experiences of IPV/SA. The Military Occupational Mental Health Model was used as a framework to understand the experience of IPV/SA within the cultural context of the military and how that context influences health and well-being. The model considers the unique context of the military, including the importance of the values of mission over individual well-being, hierarchy and subordination, leadership, and unit support, as well as what resources are made available.

Data analysis. The authors followed an inductive approach informed by grounded theory, with the goal of identifying themes and a unifying theory empirically grounded in the interview data. First, 2 members of the research team conducted independent, close readings of each transcript and applied open coding, then compared their coding to identify common patterns across transcripts. Through this process, they developed and refined a codebook to define a set of codes and guide application of codes to text. Research team members conducted line-by-line coding of each transcript, based on the codebook definitions. Then the authors read all coded text and met to discuss patterns within and between transcripts, leading to identification of 2 core categories pertaining to the relationship betweenIPV/SA and military service, as well as several subthemes within each core category.

Main results. The 2 core categories identified  had both positive and negative influences. The first was  the “experience of IPV/SA affects participation in military service, including entering and leaving military service,” and included the subthemes of coercion by the perpetrator to enter or leave military service, effects on service and work performance such as physical and mental health problems that interfered with their ability to do their job, and survival strategies that had negative repercussions on the woman’s career. The second was  the “military context shapes responses to, and coping with, experiences of IPV/SA,” and included the subthemes of military sanction for IPV (but not sexual assault) if both partners were in the military, lack of accountability for and protection of service member perpetrators due to the value of unit support, military service as an opportunity to escape through relocation, even preferring a combat zone over home, and resistance to seeking help because of expectations of invulnerability related to the warrior identity.

Conclusion. The military context can provide personal and occupational resources for women who experience IPV/SA, but the institutional (ie, chain of command reporting) and cultural context can constrain women’s ability to access resources and support, negatively affecting outcomes.

Commentary

Intimate partner violence (IPV) is a widespread public health problem in the United States and women in the military are no exception. According to Black and Merrick [1], 36.3% of active duty women experienced sexual violence in their lifetime and 39.7% experienced IPV. Violence has significant health, economic, and social consequences for women in all settings, including serious short- and long-term physical and mental health problems, economic hardship, isolation, and decreased quality of life [2–5]. Women who experience IPV/SA in any setting face challenges in protecting themselves, overcoming violence, and seeking justice, however, the context in which the violence occurs can significantly influence the individual experiences of women. This study used a qualitative approach to understand how it is experienced by service women in the context of the military.

As the authors note, military culture can both facilitate and hamper women’s recovery from the physical, psychological, and economic sequelae of IPV/SA. The rigid hierarchal structure of the military and the expectation that one supports the unit and fellow soldiers above all else makes it very difficult for women to disclose IPV/SA and seek and receive protection and justice. On the other hand, military training and service provides women with the skills and means to be independent and to physically distance themselves from the perpetrator. However, the comment of one woman that facing bombs in Iraq was preferable to facing the violence at home should serve as a reminder of how devastating IPV/SA is and suggests that victims do not think there are effective institutional deterrents or protection available to them.

As the authors note, this was a small convenience sample of women at one VA medical center. This qualitative study provides a beginning understanding that should be expanded on with multisite quantitative research with large samples. Sexual assault in the military has been recognized as a significant problem, particularly for women but also for men. We need to continue to study this problem from many different perspectives to determine how to prevent violence and to ensure all victims get the resources and effective services they need.

Applications for Clinical Practice

This study has implications for all health care providers, as active duty and veteran service women seek care outside as well as within the VA. An important finding that has direct application to practice in all settings is the influence of the warrior identity. The warrior identity has been widely acknowledged as a barrier to seeking help for depression or PTSD in service men returning from combat but not as much in service women and not in the context of IPV/SA. It is important that providers consider warrior identity in assessing and treating women for IPV/SA. Not only can this affect disclosure and prevent a victim from seeking help, but the expectation that they should have been invulnerable and strong may increase feelings of self-blame and worsen psychological distress.

 —Karen Roush, PhD, RN

Study Overview

Objective. To evaluate if exercise during pregnancy has an effect on the risk of preterm birth.

Design. Systematic review and meta-analysis of randomized controlled trials.

Study selection. The authors followed the protocol for conducting meta-analyses recommended by the Cochrane Collaboration. MEDLINE, EMBASE, Web of Science, Scopus, ClinicalTrials.gov, OVID, and the Cochrane Library were searched from the inception of each database to April 2016. Selection criteria included randomized clinical trials that examined the effect of aerobic exercise on preterm birth. Keywords included exercise or physical activity and pregnancy and preterm birth or preterm delivery. Studies were included only if women were randomized to an aerobic exercise program prior to 23 weeks, participants had uncomplicated singleton pregnancies and no contraindication to exercise, and preterm birth was an outcome.

Nine studies met the inclusion criteria and were included in the meta-analysis. The quality of included studies was good overall, with most studies having low risk of selection or attrition bias and low or unclear risk of reporting bias. Most of the studies did not include blinding of participants and research personnel or of the outcome assessment. Sample sizes ranged from 14 to 697, with 2 studies with < 100 participants, 3 with 100 to 200 participants, and 3 with 290 to 687 participants. All of the women randomized to the experimental group began an exercise program by 22 weeks’ gestation. The types of physical activity used in the experimental group included strength and flexibility training, cycling, stretching, resistance, dance, joint mobilization, walking, and toning. Participants engaged in the activity for 35 to 90 minutes (mean, 57 minutes) 3 times a week in 8 studies and 4 times a week in 1 study. The intensity of the aerobic activities ranged from less than 60% to less than 80% of age-predicted maximum heart rate. Participants in 3 control groups were explicitly told not to engage in exercise while those in the others were neither encouraged or discouraged from doing so.

Main outcome measure. Incidence of preterm birth (birth prior to 37 weeks’ gestation).

Main results. A total of 2059 women were included in the meta-analysis, with 1022 in the exercise group and 1037 in the control group. The incidence of preterm birth was similar in the experimental and the control groups (4.5% vs 4.4% respectively, 95% confidence interval [CI], –0.07 to 0.17). The mean gestational age at delivery was also similar, with a mean difference of 0.05 (95% CI, –0.07 to 0.17). Women in the exercise group had a decreased risk of cesarean delivery (0.82%), with 17.9% having a cesarean delivery compared to 22% in the control group ( 95% CI, 0.69 to 0.97).

Conclusion. Exercise during pregnancy in women with singleton, uncomplicated pregnancy is not associated with increased risk of preterm delivery. Additionally, it is associated with a decreased risk of cesarean delivery.

Commentary

Preterm birth accounts for most perinatal deaths in the United States and places surviving infants at risk for serious short- and long-term health problems [1]. Though the rate of preterm births in the United States has been slowly declining in recent years, at 9.57% it continues to be one of the highest among high-income countries [2]. Determining factors that contribute to incidence of preterm birth is critical to reducing this unacceptably high rate. According to the authors of this meta-analysis, the role of exercise related to preterm birth remains controversial due to past beliefs that the increased release of catecholamines during exercise would stimulate myometrial activity and ongoing concerns about possible adverse effects. The health benefits of regular exercise are well-known, including in pregnancy where it has been shown to lower the risk of gestational diabetes and preeclampsia.

Researchers have investigated exercise during pregnancy in earlier reviews; however, this appears to be the first with both preterm birth as the primary outcome and an adequate number of clinical trials in the sample. Prior reviews that examined the effects of exercise on preterm birth, either specifically or as one of a number of pregnancy outcomes, included only 3 to 5 studies pertaining to preterm birth [3–5].

The strengths of this review were the low statistical heterogeneity and high quality of the included studies, lack of publication bias, and the large sample of 2059 participants. As noted by the authors, however, lack of stratification by body mass (underweight, overweight, obese), differences in the types and intensity of exercise among interventions, as well as possible differences in adherence may have affected outcomes. In addition, in 6 studies women in the control group were not specifically instructed to refrain from exercise and there is no information about their exercise habits. The risk of contamination bias exists because some of these women may have engaged in a regular program of exercise. However, considering that levels of regular exercise in pregnant women are low, it is unlikely that this would occur at a rate that would have a significant effect on the outcomes [6].

Applications for Clinical Practice

The results of this meta-analysis provide strong support for the American College of Obstetrics and Gynecology recommendation that women with uncomplicated pregnancies be encouraged to engage in moderate-intensity exercise 20 to 30 minutes per day during pregnancy [7]. Clinicians should advise all women with uncomplicated singleton pregnancies and no medical contraindications to engage in regular aerobic and strength-conditioning exercise throughout their pregnancy.

—Karen Roush, PhD, RN

Study Overview

Objective. To evaluate if exercise during pregnancy has an effect on the risk of preterm birth.

Design. Systematic review and meta-analysis of randomized controlled trials.

Study selection. The authors followed the protocol for conducting meta-analyses recommended by the Cochrane Collaboration. MEDLINE, EMBASE, Web of Science, Scopus, ClinicalTrials.gov, OVID, and the Cochrane Library were searched from the inception of each database to April 2016. Selection criteria included randomized clinical trials that examined the effect of aerobic exercise on preterm birth. Keywords included exercise or physical activity and pregnancy and preterm birth or preterm delivery. Studies were included only if women were randomized to an aerobic exercise program prior to 23 weeks, participants had uncomplicated singleton pregnancies and no contraindication to exercise, and preterm birth was an outcome.

Nine studies met the inclusion criteria and were included in the meta-analysis. The quality of included studies was good overall, with most studies having low risk of selection or attrition bias and low or unclear risk of reporting bias. Most of the studies did not include blinding of participants and research personnel or of the outcome assessment. Sample sizes ranged from 14 to 697, with 2 studies with < 100 participants, 3 with 100 to 200 participants, and 3 with 290 to 687 participants. All of the women randomized to the experimental group began an exercise program by 22 weeks’ gestation. The types of physical activity used in the experimental group included strength and flexibility training, cycling, stretching, resistance, dance, joint mobilization, walking, and toning. Participants engaged in the activity for 35 to 90 minutes (mean, 57 minutes) 3 times a week in 8 studies and 4 times a week in 1 study. The intensity of the aerobic activities ranged from less than 60% to less than 80% of age-predicted maximum heart rate. Participants in 3 control groups were explicitly told not to engage in exercise while those in the others were neither encouraged or discouraged from doing so.

Main outcome measure. Incidence of preterm birth (birth prior to 37 weeks’ gestation).

Main results. A total of 2059 women were included in the meta-analysis, with 1022 in the exercise group and 1037 in the control group. The incidence of preterm birth was similar in the experimental and the control groups (4.5% vs 4.4% respectively, 95% confidence interval [CI], –0.07 to 0.17). The mean gestational age at delivery was also similar, with a mean difference of 0.05 (95% CI, –0.07 to 0.17). Women in the exercise group had a decreased risk of cesarean delivery (0.82%), with 17.9% having a cesarean delivery compared to 22% in the control group ( 95% CI, 0.69 to 0.97).

Conclusion. Exercise during pregnancy in women with singleton, uncomplicated pregnancy is not associated with increased risk of preterm delivery. Additionally, it is associated with a decreased risk of cesarean delivery.

Commentary

Preterm birth accounts for most perinatal deaths in the United States and places surviving infants at risk for serious short- and long-term health problems [1]. Though the rate of preterm births in the United States has been slowly declining in recent years, at 9.57% it continues to be one of the highest among high-income countries [2]. Determining factors that contribute to incidence of preterm birth is critical to reducing this unacceptably high rate. According to the authors of this meta-analysis, the role of exercise related to preterm birth remains controversial due to past beliefs that the increased release of catecholamines during exercise would stimulate myometrial activity and ongoing concerns about possible adverse effects. The health benefits of regular exercise are well-known, including in pregnancy where it has been shown to lower the risk of gestational diabetes and preeclampsia.

Researchers have investigated exercise during pregnancy in earlier reviews; however, this appears to be the first with both preterm birth as the primary outcome and an adequate number of clinical trials in the sample. Prior reviews that examined the effects of exercise on preterm birth, either specifically or as one of a number of pregnancy outcomes, included only 3 to 5 studies pertaining to preterm birth [3–5].

The strengths of this review were the low statistical heterogeneity and high quality of the included studies, lack of publication bias, and the large sample of 2059 participants. As noted by the authors, however, lack of stratification by body mass (underweight, overweight, obese), differences in the types and intensity of exercise among interventions, as well as possible differences in adherence may have affected outcomes. In addition, in 6 studies women in the control group were not specifically instructed to refrain from exercise and there is no information about their exercise habits. The risk of contamination bias exists because some of these women may have engaged in a regular program of exercise. However, considering that levels of regular exercise in pregnant women are low, it is unlikely that this would occur at a rate that would have a significant effect on the outcomes [6].

Applications for Clinical Practice

The results of this meta-analysis provide strong support for the American College of Obstetrics and Gynecology recommendation that women with uncomplicated pregnancies be encouraged to engage in moderate-intensity exercise 20 to 30 minutes per day during pregnancy [7]. Clinicians should advise all women with uncomplicated singleton pregnancies and no medical contraindications to engage in regular aerobic and strength-conditioning exercise throughout their pregnancy.

—Karen Roush, PhD, RN

Study Overview

Objective. To evaluate if exercise during pregnancy has an effect on the risk of preterm birth.

Design. Systematic review and meta-analysis of randomized controlled trials.

Study selection. The authors followed the protocol for conducting meta-analyses recommended by the Cochrane Collaboration. MEDLINE, EMBASE, Web of Science, Scopus, ClinicalTrials.gov, OVID, and the Cochrane Library were searched from the inception of each database to April 2016. Selection criteria included randomized clinical trials that examined the effect of aerobic exercise on preterm birth. Keywords included exercise or physical activity and pregnancy and preterm birth or preterm delivery. Studies were included only if women were randomized to an aerobic exercise program prior to 23 weeks, participants had uncomplicated singleton pregnancies and no contraindication to exercise, and preterm birth was an outcome.

Nine studies met the inclusion criteria and were included in the meta-analysis. The quality of included studies was good overall, with most studies having low risk of selection or attrition bias and low or unclear risk of reporting bias. Most of the studies did not include blinding of participants and research personnel or of the outcome assessment. Sample sizes ranged from 14 to 697, with 2 studies with < 100 participants, 3 with 100 to 200 participants, and 3 with 290 to 687 participants. All of the women randomized to the experimental group began an exercise program by 22 weeks’ gestation. The types of physical activity used in the experimental group included strength and flexibility training, cycling, stretching, resistance, dance, joint mobilization, walking, and toning. Participants engaged in the activity for 35 to 90 minutes (mean, 57 minutes) 3 times a week in 8 studies and 4 times a week in 1 study. The intensity of the aerobic activities ranged from less than 60% to less than 80% of age-predicted maximum heart rate. Participants in 3 control groups were explicitly told not to engage in exercise while those in the others were neither encouraged or discouraged from doing so.

Main outcome measure. Incidence of preterm birth (birth prior to 37 weeks’ gestation).

Main results. A total of 2059 women were included in the meta-analysis, with 1022 in the exercise group and 1037 in the control group. The incidence of preterm birth was similar in the experimental and the control groups (4.5% vs 4.4% respectively, 95% confidence interval [CI], –0.07 to 0.17). The mean gestational age at delivery was also similar, with a mean difference of 0.05 (95% CI, –0.07 to 0.17). Women in the exercise group had a decreased risk of cesarean delivery (0.82%), with 17.9% having a cesarean delivery compared to 22% in the control group ( 95% CI, 0.69 to 0.97).

Conclusion. Exercise during pregnancy in women with singleton, uncomplicated pregnancy is not associated with increased risk of preterm delivery. Additionally, it is associated with a decreased risk of cesarean delivery.

Commentary

Preterm birth accounts for most perinatal deaths in the United States and places surviving infants at risk for serious short- and long-term health problems [1]. Though the rate of preterm births in the United States has been slowly declining in recent years, at 9.57% it continues to be one of the highest among high-income countries [2]. Determining factors that contribute to incidence of preterm birth is critical to reducing this unacceptably high rate. According to the authors of this meta-analysis, the role of exercise related to preterm birth remains controversial due to past beliefs that the increased release of catecholamines during exercise would stimulate myometrial activity and ongoing concerns about possible adverse effects. The health benefits of regular exercise are well-known, including in pregnancy where it has been shown to lower the risk of gestational diabetes and preeclampsia.

Researchers have investigated exercise during pregnancy in earlier reviews; however, this appears to be the first with both preterm birth as the primary outcome and an adequate number of clinical trials in the sample. Prior reviews that examined the effects of exercise on preterm birth, either specifically or as one of a number of pregnancy outcomes, included only 3 to 5 studies pertaining to preterm birth [3–5].

The strengths of this review were the low statistical heterogeneity and high quality of the included studies, lack of publication bias, and the large sample of 2059 participants. As noted by the authors, however, lack of stratification by body mass (underweight, overweight, obese), differences in the types and intensity of exercise among interventions, as well as possible differences in adherence may have affected outcomes. In addition, in 6 studies women in the control group were not specifically instructed to refrain from exercise and there is no information about their exercise habits. The risk of contamination bias exists because some of these women may have engaged in a regular program of exercise. However, considering that levels of regular exercise in pregnant women are low, it is unlikely that this would occur at a rate that would have a significant effect on the outcomes [6].

Applications for Clinical Practice

The results of this meta-analysis provide strong support for the American College of Obstetrics and Gynecology recommendation that women with uncomplicated pregnancies be encouraged to engage in moderate-intensity exercise 20 to 30 minutes per day during pregnancy [7]. Clinicians should advise all women with uncomplicated singleton pregnancies and no medical contraindications to engage in regular aerobic and strength-conditioning exercise throughout their pregnancy.

—Karen Roush, PhD, RN

Study Overview

Objective. To examine the effects of acupuncture on vasomotor symptoms (VMS) and quality of life in perimenopausal and postmenopausal women.

Design. Pragmatic randomized controlled trial.

Setting and participants. Participants were perimenopausal and postmenopausal women aged 45 to 60 years who had 4 or more VMS episodes a day. Women were excluded if they had initiated or changed a dose of any VMS treatment in the 4 weeks prior to the study, initiated or changed the dose of an antidepressant in the prior 3 months, had received acupuncture in the prior 4 weeks, self-reported their health as poor or fair, or had a diagnosis of hemophilia. The study was conducted at the Wake Forest School of Medicine and the Chapel Hill Doctors Healthcare Center in North Carolina with women recruited from the community. Potential participants completed a 2-week hot flash diary to establish that they met the eligibility criteria of 4 or more hot flashes a day.

Intervention. Eligible participants were randomized to either the experimental group, who received up to 20 acupuncture treatments over a 6-month period, or a waitlist control group who received usual care for 6 months followed by the same 6 months of acupuncture treatment received by the experimental group. The researchers decided not to use sham acupuncture in the control group because outside of the experiment women would not receive sham acupuncture and because it has been shown to have an effect on menopausal symptoms in other studies.

Participants could receive up to 20 acupuncture treatments from 1 of the 4 study licensed acupuncturists over a period of 6 months. The acupuncturist assessed the participant and made a traditional Chinese medicine diagnosis to guide treatment at the initial and each subsequent visit. During treatment, acupuncture needles were inserted 0.5 to 3 cm through the skin to achieve a “de Qi” sensation, which is a sensation of heaviness, numbness, soreness, or distention at the insertion site. Acupuncturists were permitted to administer additional acupuncture-related treatments with the exception of the use of Chinese herbal remedies. Additionally, participants were permitted to start other treatments, and 11 women in the acupuncture group and 2 women in the control group started other behavioral treatments during the study.

Main outcome measures. The primary outcome measure was the frequency and severity of hot flashes and night sweats, measured using the Daily Diary of Hot Flashes (DDHF). Secondary measures were the following quality of life indicators: hot flash interference (the degree to which hot flashes interfered with specific daily activities), measured using the Hot Flash-related Daily Interference Scale; sleep quality, measured using the Pittsburgh Sleep Quality Index (PSQI) and the PROMIS Sleep Disturbance short form; menopause related symptoms other than VMS, measured using the Women’s Health Questionaire (WHQ); depression, measured using the short form of the Center for Epidemiologic Studies Depression scale (CESD-10); anxiety, measured using the General Anxiety Disorder (GAD-7) and the PROMIS Anxiety short form; perceived stress, measured using the Perceived Stress Scale (PSS); and health-related quality of life (HRQOL), measured using a global visual analog scale (VAS) and the Physical and Mental Health Component scores of the Medical Outcomes Study short form health survey (SF-36).

Main results. The final sample size was 209 women, with 170 randomized to the acupuncture group and 39 to the control group. There were no significant differences between the groups at baseline. The retention rate was 89% at 6 months and 84% at 12 months. At 6 months there was a 36.7% decrease VMS frequency in the acupuncture group compared to a 6.0% increase in the control group (P < 0.001). At 12 months the decrease in VMS frequency was 29.5% in the acupuncture group. The control group began acupuncture at 6 months and by 12 months the frequency of VMS in this group was 31.0% less than at baseline (P < 0.001). Overall, the maximal effect was achieved at week 7 with a median of 8 acupuncture treatments. Sensitivity analysis indicated that there were no differences in effect in those who started other behavioral treatments during this period. There were also significant improvements in scores on the hot flash interference scale (P < 0.001), fewer sleep problems on the sleep measures, and fewer symptoms on the WHQ for women in the acupuncture group and these effects were maintained at 12 months. In addition, similar results were found in the control group after they initiated acupuncture at 6 months.

Conclusion. Overall, acupuncture resulted in significant and sustained improvements in VMS and quality of life measures.

Commentary

More than half of women will experience frequent VMS beginning with the menopause transition [1] and lasting an average of 7.4 years [2]. The effect of VMS on women’s quality of life is considerable, including anxiety, stress, decreased energy, sleep disruption and interference with leisure, social, and work activities [3,4]. Estrogen therapy remains the most effective therapy for VMS; however, its use is contraindicated in many women and duration of use is limited [5]. Therefore, safe and effective alternate therapies are needed.

Acupuncture is a traditional Chinese medicine therapy that has gained popularity in recent years for therapeutic management of many conditions, including pain, nausea related to pregnancy or chemotherapy, anxiety, headache, and addiction. Evidence regarding effectiveness has been equivocal, with studies of its effectiveness in some conditions, such as nausea and dental pain, showing strong positive results while evidence for its use in other conditions is lacking or inconsistent [6]. There have been consistent positive findings in prior research of the use of acupuncture to reduce the severity and frequency of VMS, however, according to the authors of this study, little is known about the long-term effects or the effect on quality of life. Additionally, most studies use sham acupuncture in the control group, which would not be offered to women outside a study protocol and has been shown to have a physiological effect of its own. Therefore, the authors conducted a pragmatic randomized control trial; designing the intervention so that it more closely reflected what happens in a real world clinical setting, to examine the overall effects and effect on quality of life measures.

The results of this study were a significant positive effect of acupuncture on the frequency and severity of VMS in the acupuncture group that was sustained over 12 months and improvements on all quality of life measures. There was also a significant effect in the control group when they received the intervention after the initial 6-month period. As the authors note, it is unclear if improvements in the quality of life indicators were a direct effect of the acupuncture or secondary to the relief of the vasomotor symptoms. Its use in women who experience other menopause-related symptoms, such as mood disorders or sleep disruption, in the absence of VMS needs further study.

The authors compare their results with that of research on the use of selective serotonin reuptake inhibitors (SSRIs) for VMS, one of the more efficacious alternatives to hormone therapy. As they note, though the reduction was somewhat less than that found with SSRIs (for example 35% for acupuncture vs. 47% with escitalopram), the risk of adverse effects is much lower with acupuncture. The only reported adverse effects in this study were 2 women who reported pain during treatment and 1 who reported numbness while SSRIs are known to have significant adverse effects. In addition, the results in this study were sustained longer, until the final follow-up at 6 months, while women who used escitalopram relapsed three weeks after discontinuing the medication.

The use of a pragmatic design allows for more confidence that the findings will translate to the real world setting. The number and timing of acupuncture treatments were determined by each woman with the acupuncturist as would happen in the clinical setting. In addition, the initiation of other therapies during the treatment stage was allowed, with 11 women in the acupuncture group and 2 women in the treatment group starting other behavioral interventions during that time. Though this approach has a small chance of introducing confounding variables, sensitivity analysis indicated it did not. As such, this design results in a study that is an accurate reflection of the experience of women receiving acupuncture in the clinical setting and thus good external validity.

There were 2 limitations of note. Though retention was excellent, 89% and 84% for the acupuncture and control group respectively, it is unknown if the women who dropped out did so due to lack of improvement, in which case the actual reduction in VMS would have been less than reported. Additionally, the use of self-report (diaries) of VMS can be unreliable and biased.

Applications for Clinical Practice

The results of this study indicate that acupuncture offers women a safe and effective therapy for VMS. The optimal dose appears to be 8 treatments. Clinicians should consider it as a first-line treatment for women with moderate to severe VMS who have contraindications to hormone therapy and before prescribing SSRI therapy, which carries the potential for significant adverse effects.

 —Karen Roush, PhD, RN

Study Overview

Objective. To examine the effects of acupuncture on vasomotor symptoms (VMS) and quality of life in perimenopausal and postmenopausal women.

Design. Pragmatic randomized controlled trial.

Setting and participants. Participants were perimenopausal and postmenopausal women aged 45 to 60 years who had 4 or more VMS episodes a day. Women were excluded if they had initiated or changed a dose of any VMS treatment in the 4 weeks prior to the study, initiated or changed the dose of an antidepressant in the prior 3 months, had received acupuncture in the prior 4 weeks, self-reported their health as poor or fair, or had a diagnosis of hemophilia. The study was conducted at the Wake Forest School of Medicine and the Chapel Hill Doctors Healthcare Center in North Carolina with women recruited from the community. Potential participants completed a 2-week hot flash diary to establish that they met the eligibility criteria of 4 or more hot flashes a day.

Intervention. Eligible participants were randomized to either the experimental group, who received up to 20 acupuncture treatments over a 6-month period, or a waitlist control group who received usual care for 6 months followed by the same 6 months of acupuncture treatment received by the experimental group. The researchers decided not to use sham acupuncture in the control group because outside of the experiment women would not receive sham acupuncture and because it has been shown to have an effect on menopausal symptoms in other studies.

Participants could receive up to 20 acupuncture treatments from 1 of the 4 study licensed acupuncturists over a period of 6 months. The acupuncturist assessed the participant and made a traditional Chinese medicine diagnosis to guide treatment at the initial and each subsequent visit. During treatment, acupuncture needles were inserted 0.5 to 3 cm through the skin to achieve a “de Qi” sensation, which is a sensation of heaviness, numbness, soreness, or distention at the insertion site. Acupuncturists were permitted to administer additional acupuncture-related treatments with the exception of the use of Chinese herbal remedies. Additionally, participants were permitted to start other treatments, and 11 women in the acupuncture group and 2 women in the control group started other behavioral treatments during the study.

Main outcome measures. The primary outcome measure was the frequency and severity of hot flashes and night sweats, measured using the Daily Diary of Hot Flashes (DDHF). Secondary measures were the following quality of life indicators: hot flash interference (the degree to which hot flashes interfered with specific daily activities), measured using the Hot Flash-related Daily Interference Scale; sleep quality, measured using the Pittsburgh Sleep Quality Index (PSQI) and the PROMIS Sleep Disturbance short form; menopause related symptoms other than VMS, measured using the Women’s Health Questionaire (WHQ); depression, measured using the short form of the Center for Epidemiologic Studies Depression scale (CESD-10); anxiety, measured using the General Anxiety Disorder (GAD-7) and the PROMIS Anxiety short form; perceived stress, measured using the Perceived Stress Scale (PSS); and health-related quality of life (HRQOL), measured using a global visual analog scale (VAS) and the Physical and Mental Health Component scores of the Medical Outcomes Study short form health survey (SF-36).

Main results. The final sample size was 209 women, with 170 randomized to the acupuncture group and 39 to the control group. There were no significant differences between the groups at baseline. The retention rate was 89% at 6 months and 84% at 12 months. At 6 months there was a 36.7% decrease VMS frequency in the acupuncture group compared to a 6.0% increase in the control group (P < 0.001). At 12 months the decrease in VMS frequency was 29.5% in the acupuncture group. The control group began acupuncture at 6 months and by 12 months the frequency of VMS in this group was 31.0% less than at baseline (P < 0.001). Overall, the maximal effect was achieved at week 7 with a median of 8 acupuncture treatments. Sensitivity analysis indicated that there were no differences in effect in those who started other behavioral treatments during this period. There were also significant improvements in scores on the hot flash interference scale (P < 0.001), fewer sleep problems on the sleep measures, and fewer symptoms on the WHQ for women in the acupuncture group and these effects were maintained at 12 months. In addition, similar results were found in the control group after they initiated acupuncture at 6 months.

Conclusion. Overall, acupuncture resulted in significant and sustained improvements in VMS and quality of life measures.

Commentary

More than half of women will experience frequent VMS beginning with the menopause transition [1] and lasting an average of 7.4 years [2]. The effect of VMS on women’s quality of life is considerable, including anxiety, stress, decreased energy, sleep disruption and interference with leisure, social, and work activities [3,4]. Estrogen therapy remains the most effective therapy for VMS; however, its use is contraindicated in many women and duration of use is limited [5]. Therefore, safe and effective alternate therapies are needed.

Acupuncture is a traditional Chinese medicine therapy that has gained popularity in recent years for therapeutic management of many conditions, including pain, nausea related to pregnancy or chemotherapy, anxiety, headache, and addiction. Evidence regarding effectiveness has been equivocal, with studies of its effectiveness in some conditions, such as nausea and dental pain, showing strong positive results while evidence for its use in other conditions is lacking or inconsistent [6]. There have been consistent positive findings in prior research of the use of acupuncture to reduce the severity and frequency of VMS, however, according to the authors of this study, little is known about the long-term effects or the effect on quality of life. Additionally, most studies use sham acupuncture in the control group, which would not be offered to women outside a study protocol and has been shown to have a physiological effect of its own. Therefore, the authors conducted a pragmatic randomized control trial; designing the intervention so that it more closely reflected what happens in a real world clinical setting, to examine the overall effects and effect on quality of life measures.

The results of this study were a significant positive effect of acupuncture on the frequency and severity of VMS in the acupuncture group that was sustained over 12 months and improvements on all quality of life measures. There was also a significant effect in the control group when they received the intervention after the initial 6-month period. As the authors note, it is unclear if improvements in the quality of life indicators were a direct effect of the acupuncture or secondary to the relief of the vasomotor symptoms. Its use in women who experience other menopause-related symptoms, such as mood disorders or sleep disruption, in the absence of VMS needs further study.

The authors compare their results with that of research on the use of selective serotonin reuptake inhibitors (SSRIs) for VMS, one of the more efficacious alternatives to hormone therapy. As they note, though the reduction was somewhat less than that found with SSRIs (for example 35% for acupuncture vs. 47% with escitalopram), the risk of adverse effects is much lower with acupuncture. The only reported adverse effects in this study were 2 women who reported pain during treatment and 1 who reported numbness while SSRIs are known to have significant adverse effects. In addition, the results in this study were sustained longer, until the final follow-up at 6 months, while women who used escitalopram relapsed three weeks after discontinuing the medication.

The use of a pragmatic design allows for more confidence that the findings will translate to the real world setting. The number and timing of acupuncture treatments were determined by each woman with the acupuncturist as would happen in the clinical setting. In addition, the initiation of other therapies during the treatment stage was allowed, with 11 women in the acupuncture group and 2 women in the treatment group starting other behavioral interventions during that time. Though this approach has a small chance of introducing confounding variables, sensitivity analysis indicated it did not. As such, this design results in a study that is an accurate reflection of the experience of women receiving acupuncture in the clinical setting and thus good external validity.

There were 2 limitations of note. Though retention was excellent, 89% and 84% for the acupuncture and control group respectively, it is unknown if the women who dropped out did so due to lack of improvement, in which case the actual reduction in VMS would have been less than reported. Additionally, the use of self-report (diaries) of VMS can be unreliable and biased.

Applications for Clinical Practice

The results of this study indicate that acupuncture offers women a safe and effective therapy for VMS. The optimal dose appears to be 8 treatments. Clinicians should consider it as a first-line treatment for women with moderate to severe VMS who have contraindications to hormone therapy and before prescribing SSRI therapy, which carries the potential for significant adverse effects.

 —Karen Roush, PhD, RN

Study Overview

Objective. To examine the effects of acupuncture on vasomotor symptoms (VMS) and quality of life in perimenopausal and postmenopausal women.

Design. Pragmatic randomized controlled trial.

Setting and participants. Participants were perimenopausal and postmenopausal women aged 45 to 60 years who had 4 or more VMS episodes a day. Women were excluded if they had initiated or changed a dose of any VMS treatment in the 4 weeks prior to the study, initiated or changed the dose of an antidepressant in the prior 3 months, had received acupuncture in the prior 4 weeks, self-reported their health as poor or fair, or had a diagnosis of hemophilia. The study was conducted at the Wake Forest School of Medicine and the Chapel Hill Doctors Healthcare Center in North Carolina with women recruited from the community. Potential participants completed a 2-week hot flash diary to establish that they met the eligibility criteria of 4 or more hot flashes a day.

Intervention. Eligible participants were randomized to either the experimental group, who received up to 20 acupuncture treatments over a 6-month period, or a waitlist control group who received usual care for 6 months followed by the same 6 months of acupuncture treatment received by the experimental group. The researchers decided not to use sham acupuncture in the control group because outside of the experiment women would not receive sham acupuncture and because it has been shown to have an effect on menopausal symptoms in other studies.

Participants could receive up to 20 acupuncture treatments from 1 of the 4 study licensed acupuncturists over a period of 6 months. The acupuncturist assessed the participant and made a traditional Chinese medicine diagnosis to guide treatment at the initial and each subsequent visit. During treatment, acupuncture needles were inserted 0.5 to 3 cm through the skin to achieve a “de Qi” sensation, which is a sensation of heaviness, numbness, soreness, or distention at the insertion site. Acupuncturists were permitted to administer additional acupuncture-related treatments with the exception of the use of Chinese herbal remedies. Additionally, participants were permitted to start other treatments, and 11 women in the acupuncture group and 2 women in the control group started other behavioral treatments during the study.

Main outcome measures. The primary outcome measure was the frequency and severity of hot flashes and night sweats, measured using the Daily Diary of Hot Flashes (DDHF). Secondary measures were the following quality of life indicators: hot flash interference (the degree to which hot flashes interfered with specific daily activities), measured using the Hot Flash-related Daily Interference Scale; sleep quality, measured using the Pittsburgh Sleep Quality Index (PSQI) and the PROMIS Sleep Disturbance short form; menopause related symptoms other than VMS, measured using the Women’s Health Questionaire (WHQ); depression, measured using the short form of the Center for Epidemiologic Studies Depression scale (CESD-10); anxiety, measured using the General Anxiety Disorder (GAD-7) and the PROMIS Anxiety short form; perceived stress, measured using the Perceived Stress Scale (PSS); and health-related quality of life (HRQOL), measured using a global visual analog scale (VAS) and the Physical and Mental Health Component scores of the Medical Outcomes Study short form health survey (SF-36).

Main results. The final sample size was 209 women, with 170 randomized to the acupuncture group and 39 to the control group. There were no significant differences between the groups at baseline. The retention rate was 89% at 6 months and 84% at 12 months. At 6 months there was a 36.7% decrease VMS frequency in the acupuncture group compared to a 6.0% increase in the control group (P < 0.001). At 12 months the decrease in VMS frequency was 29.5% in the acupuncture group. The control group began acupuncture at 6 months and by 12 months the frequency of VMS in this group was 31.0% less than at baseline (P < 0.001). Overall, the maximal effect was achieved at week 7 with a median of 8 acupuncture treatments. Sensitivity analysis indicated that there were no differences in effect in those who started other behavioral treatments during this period. There were also significant improvements in scores on the hot flash interference scale (P < 0.001), fewer sleep problems on the sleep measures, and fewer symptoms on the WHQ for women in the acupuncture group and these effects were maintained at 12 months. In addition, similar results were found in the control group after they initiated acupuncture at 6 months.

Conclusion. Overall, acupuncture resulted in significant and sustained improvements in VMS and quality of life measures.

Commentary

More than half of women will experience frequent VMS beginning with the menopause transition [1] and lasting an average of 7.4 years [2]. The effect of VMS on women’s quality of life is considerable, including anxiety, stress, decreased energy, sleep disruption and interference with leisure, social, and work activities [3,4]. Estrogen therapy remains the most effective therapy for VMS; however, its use is contraindicated in many women and duration of use is limited [5]. Therefore, safe and effective alternate therapies are needed.

Acupuncture is a traditional Chinese medicine therapy that has gained popularity in recent years for therapeutic management of many conditions, including pain, nausea related to pregnancy or chemotherapy, anxiety, headache, and addiction. Evidence regarding effectiveness has been equivocal, with studies of its effectiveness in some conditions, such as nausea and dental pain, showing strong positive results while evidence for its use in other conditions is lacking or inconsistent [6]. There have been consistent positive findings in prior research of the use of acupuncture to reduce the severity and frequency of VMS, however, according to the authors of this study, little is known about the long-term effects or the effect on quality of life. Additionally, most studies use sham acupuncture in the control group, which would not be offered to women outside a study protocol and has been shown to have a physiological effect of its own. Therefore, the authors conducted a pragmatic randomized control trial; designing the intervention so that it more closely reflected what happens in a real world clinical setting, to examine the overall effects and effect on quality of life measures.

The results of this study were a significant positive effect of acupuncture on the frequency and severity of VMS in the acupuncture group that was sustained over 12 months and improvements on all quality of life measures. There was also a significant effect in the control group when they received the intervention after the initial 6-month period. As the authors note, it is unclear if improvements in the quality of life indicators were a direct effect of the acupuncture or secondary to the relief of the vasomotor symptoms. Its use in women who experience other menopause-related symptoms, such as mood disorders or sleep disruption, in the absence of VMS needs further study.

The authors compare their results with that of research on the use of selective serotonin reuptake inhibitors (SSRIs) for VMS, one of the more efficacious alternatives to hormone therapy. As they note, though the reduction was somewhat less than that found with SSRIs (for example 35% for acupuncture vs. 47% with escitalopram), the risk of adverse effects is much lower with acupuncture. The only reported adverse effects in this study were 2 women who reported pain during treatment and 1 who reported numbness while SSRIs are known to have significant adverse effects. In addition, the results in this study were sustained longer, until the final follow-up at 6 months, while women who used escitalopram relapsed three weeks after discontinuing the medication.

The use of a pragmatic design allows for more confidence that the findings will translate to the real world setting. The number and timing of acupuncture treatments were determined by each woman with the acupuncturist as would happen in the clinical setting. In addition, the initiation of other therapies during the treatment stage was allowed, with 11 women in the acupuncture group and 2 women in the treatment group starting other behavioral interventions during that time. Though this approach has a small chance of introducing confounding variables, sensitivity analysis indicated it did not. As such, this design results in a study that is an accurate reflection of the experience of women receiving acupuncture in the clinical setting and thus good external validity.

There were 2 limitations of note. Though retention was excellent, 89% and 84% for the acupuncture and control group respectively, it is unknown if the women who dropped out did so due to lack of improvement, in which case the actual reduction in VMS would have been less than reported. Additionally, the use of self-report (diaries) of VMS can be unreliable and biased.

Applications for Clinical Practice

The results of this study indicate that acupuncture offers women a safe and effective therapy for VMS. The optimal dose appears to be 8 treatments. Clinicians should consider it as a first-line treatment for women with moderate to severe VMS who have contraindications to hormone therapy and before prescribing SSRI therapy, which carries the potential for significant adverse effects.

 —Karen Roush, PhD, RN

Study Overview

Objective. To examine the efficacy and safety of weight-loss surgery in adolescents.

Design. Prospective observational study.

Setting and participants. Adolescents (aged 13–19 years) with severe obesity undergoing bariatric surgery at 5 U.S. hospitals and medical centers from March 2007 through February 2012. Participants were enrolled in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study, a longitudinal prospective study that investigated the risks and benefits of adolescent bariatric surgery.

Main outcome measures. Data was collected on weight, comorbidities, cardiometabolic risk factors, nutritional status, and weight-related quality of life at research visits scheduled at 6 months, 1 year, 2 years, and 3 years post bariatric surgery. Researchers measured height and weight and blood pressure directly and calculated BMI. They assessed for comorbidities and cardiometabolic risk factors through urine and serum laboratory tests of lipids, glomerular filtration rate, albumin, glycated hemoglobin, fasting glucose level, and insulin. They assessed nutritional status with laboratory values for serum albumin, folate, vitamin B₁₂, 25-hydroxyvitamin D, parathyroid hormone, ferritin, transferrin, vitamin A, and vitamin B₁ erythrocyte transketolase. Researchers conducted interviews with the participants to collect information about subsequent medical or surgical procedures or, if participants missed a research visit, they obtained information through chart reviews. Finally, weight-related quality of life was assessed with the Impact of Weight on Quality of Life-Kids instrument, a validated self-report measure with 27 items divided into 4 subscales: physical comfort, body esteem, social life, and family relations.

Main results. Analysis was conducted on results for 228 of 242 participants who received Roux-en-Y gastric bypass (n = 161) and sleeve gastrectomy (n = 67). Results for 14 participants who received adjustable gastric banding were not included due to the small size of that group. Mean weight loss was 41 kg while mean height increased by only 0.51 cm. The mean percentage of weight loss was 27% overall and was similar in both groups, 28% in participants who underwent gastric bypass and 26% in those who underwent sleeve gastrectomy. At the 3-year visit, there were statistically significant improvements in comorbidities: 74% of the 96 participants with elevated blood pressure, 66% of the 171 participants with dyslipidemia, and 86% of the 36 participants with abnormal kidney function at baseline had values within the normal range. None of 3 participants with type 1 diabetes at baseline had resolution. However, 29 participants had type 2 diabetes (median glycolated hemoglobin 6.3% at baseline) and 19 of 20 of them for whom data were available at 3 years were in remission, with a median glycolated hemoglobin of 5.3%. There was an increase in the number of participants with micronutrient deficiencies at the 3-year mark: the percentage of participants with low ferritin levels increased from 5% at baseline to 57%, those with low vitamin B₁₂ increased from < 1% to 8%, and those with low vitamin A increased from 6% to 16%. During the 3-year follow-up period, 30 participants underwent 44 intrabdominal procedures related to the bariatric procedure and 29 participants underwent 48 endoscopic procedures, including stricture dilatation (n = 11). Total scores on the Impact of Weight on Quality of Life-Kids instrument improved from a mean of 63 at baseline to 83 at 3 years.

Conclusion. Overall there were significant improvements in weight, comorbidities, cardiometabolic health, and weight-related quality of life. However, there were also risks, including increased micronutrient deficiencies and the need for subsequent invasive abdominal procedures.

Commentary

Pediatric obesity is one of the most significant health problems facing children and adolescents. According to the most recent estimates, 34.5% of all adolescents aged 12 to 19 years are overweight or obese [1]. Pediatric obesity has serious short- and long-term psychosocial and physical implications. Obese adolescents suffer from social marginalization, poor self-concept, and lower health-related quality of life [2,3]. They are at greater risk for metabolic syndrome, diabetes, obstructive sleep apnea, and conditions associated with coronary artery disease such as hyperlipidemia and hypertension [4,5]. Additionally, obesity in adolescence is strongly associated with early mortality and years of life lost [6].

Despite extensive research and public health campaigns, rates of adolescent obesity have not decreased since 2003 [1]. Diet and behavioral approaches have had limited success and are rarely sustained over time. Bariatric surgery is an approach that has been used safely and effectively in severely obese adults and is increasingly being used for adolescents as well [7]. The results of this study are encouraging in that they suggest that bariatric surgery is effective in adolescents, leading to significant and sustained weight loss over 3 years and improved cardiometabolic health and weight-related quality of life.

The procedures are not without risks as demonstrated by the findings of micronutrient deficiencies and the need for follow-up intraabdominal and endoscopic procedures. The number of follow-up procedures and the fact that they continued into the third year is concerning. More details about this finding, such as characteristics of participants who required them, would be helpful. Further research to determine risk factors associated with complications that require subsequent invasive procedures is important for developing criteria for selection of candidates for bariatric surgery. Additionally, there was no information on impact of the follow-up procedures on participants or the conditions that precipitated them. In addition, there was no information on physical sequelae that can cause ongoing distress for patients, eg, chronic abdominal cramping and pain. The authors measured weight-related quality of life but measuring overall quality of life post-procedure would have captured the impact of post-procedure dietary restrictions and any medical problems. Such data could be helpful in decision-making about the use of bariatric procedures in this population versus noninvasive approaches to management.

As the authors note, treating severe obesity in adolescence rather than waiting until adulthood may have significant implications for improved health in adulthood, particularly in preventing or reversing cardiovascular damage related to obesity-related cardiometabolic risk factors. However, what is not known yet is whether the positive outcomes, beginning with weight loss, are sustained through adulthood. This 3-year longitudinal study was the first to examine factors over an extended time period, however, considering the average life expectancy of an adolescent, it provides only a relatively short-term outlook. A longitudinal study that follows a cohort of adolescents from the time of the bariatric procedure into middle age or beyond is needed. Such a study would also provide needed information about the long-term consequences of repeated intraabdominal procedures and the persistence or resolution of micronutrient deficiencies and their effects on health.

The strengths of this study are its prospective longitudinal design and its high rate of cohort completion (99% of participants remained actively involved, completing 88% of follow-up visits). As the authors note, the lack of a control group of adolescents treated with diet and behavioral approaches prevents any definitive statement about the benefits and risks compared to nonsurgical approaches. However, previous research indicates that weight loss is not as great nor sustained when nonsurgical approaches are used.

Applications for Clinical Practice

The use of bariatric surgery in adolescents is a promising approach to a major health problem that has proven resistant to concerted medical and public health efforts and the use of nonsurgical treatments. Ongoing longitudinal research is needed but the positive outcomes seen here—sustained significant weight loss, improvement in cardiometabolic risk factors and comorbidities, and improved weight-related quality of life—indicate that bariatric surgery is an effective treatment for adolescent obesity when diet and behavioral approaches have failed. However, the occurrence of post-procedure complications also highlights the need for caution. Clinicians must carefully weigh the risk-benefit ratio for each individual, taking into consideration the long-term implications of severe obesity, any potential for significant weight loss with diet and behavioral changes, and the positive outcomes of bariatric surgery demonstrated here.

 —Karen Roush, PhD, RN

Study Overview

Objective. To examine the efficacy and safety of weight-loss surgery in adolescents.

Design. Prospective observational study.

Setting and participants. Adolescents (aged 13–19 years) with severe obesity undergoing bariatric surgery at 5 U.S. hospitals and medical centers from March 2007 through February 2012. Participants were enrolled in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study, a longitudinal prospective study that investigated the risks and benefits of adolescent bariatric surgery.

Main outcome measures. Data was collected on weight, comorbidities, cardiometabolic risk factors, nutritional status, and weight-related quality of life at research visits scheduled at 6 months, 1 year, 2 years, and 3 years post bariatric surgery. Researchers measured height and weight and blood pressure directly and calculated BMI. They assessed for comorbidities and cardiometabolic risk factors through urine and serum laboratory tests of lipids, glomerular filtration rate, albumin, glycated hemoglobin, fasting glucose level, and insulin. They assessed nutritional status with laboratory values for serum albumin, folate, vitamin B₁₂, 25-hydroxyvitamin D, parathyroid hormone, ferritin, transferrin, vitamin A, and vitamin B₁ erythrocyte transketolase. Researchers conducted interviews with the participants to collect information about subsequent medical or surgical procedures or, if participants missed a research visit, they obtained information through chart reviews. Finally, weight-related quality of life was assessed with the Impact of Weight on Quality of Life-Kids instrument, a validated self-report measure with 27 items divided into 4 subscales: physical comfort, body esteem, social life, and family relations.

Main results. Analysis was conducted on results for 228 of 242 participants who received Roux-en-Y gastric bypass (n = 161) and sleeve gastrectomy (n = 67). Results for 14 participants who received adjustable gastric banding were not included due to the small size of that group. Mean weight loss was 41 kg while mean height increased by only 0.51 cm. The mean percentage of weight loss was 27% overall and was similar in both groups, 28% in participants who underwent gastric bypass and 26% in those who underwent sleeve gastrectomy. At the 3-year visit, there were statistically significant improvements in comorbidities: 74% of the 96 participants with elevated blood pressure, 66% of the 171 participants with dyslipidemia, and 86% of the 36 participants with abnormal kidney function at baseline had values within the normal range. None of 3 participants with type 1 diabetes at baseline had resolution. However, 29 participants had type 2 diabetes (median glycolated hemoglobin 6.3% at baseline) and 19 of 20 of them for whom data were available at 3 years were in remission, with a median glycolated hemoglobin of 5.3%. There was an increase in the number of participants with micronutrient deficiencies at the 3-year mark: the percentage of participants with low ferritin levels increased from 5% at baseline to 57%, those with low vitamin B₁₂ increased from < 1% to 8%, and those with low vitamin A increased from 6% to 16%. During the 3-year follow-up period, 30 participants underwent 44 intrabdominal procedures related to the bariatric procedure and 29 participants underwent 48 endoscopic procedures, including stricture dilatation (n = 11). Total scores on the Impact of Weight on Quality of Life-Kids instrument improved from a mean of 63 at baseline to 83 at 3 years.

Conclusion. Overall there were significant improvements in weight, comorbidities, cardiometabolic health, and weight-related quality of life. However, there were also risks, including increased micronutrient deficiencies and the need for subsequent invasive abdominal procedures.

Commentary

Pediatric obesity is one of the most significant health problems facing children and adolescents. According to the most recent estimates, 34.5% of all adolescents aged 12 to 19 years are overweight or obese [1]. Pediatric obesity has serious short- and long-term psychosocial and physical implications. Obese adolescents suffer from social marginalization, poor self-concept, and lower health-related quality of life [2,3]. They are at greater risk for metabolic syndrome, diabetes, obstructive sleep apnea, and conditions associated with coronary artery disease such as hyperlipidemia and hypertension [4,5]. Additionally, obesity in adolescence is strongly associated with early mortality and years of life lost [6].

Despite extensive research and public health campaigns, rates of adolescent obesity have not decreased since 2003 [1]. Diet and behavioral approaches have had limited success and are rarely sustained over time. Bariatric surgery is an approach that has been used safely and effectively in severely obese adults and is increasingly being used for adolescents as well [7]. The results of this study are encouraging in that they suggest that bariatric surgery is effective in adolescents, leading to significant and sustained weight loss over 3 years and improved cardiometabolic health and weight-related quality of life.

The procedures are not without risks as demonstrated by the findings of micronutrient deficiencies and the need for follow-up intraabdominal and endoscopic procedures. The number of follow-up procedures and the fact that they continued into the third year is concerning. More details about this finding, such as characteristics of participants who required them, would be helpful. Further research to determine risk factors associated with complications that require subsequent invasive procedures is important for developing criteria for selection of candidates for bariatric surgery. Additionally, there was no information on impact of the follow-up procedures on participants or the conditions that precipitated them. In addition, there was no information on physical sequelae that can cause ongoing distress for patients, eg, chronic abdominal cramping and pain. The authors measured weight-related quality of life but measuring overall quality of life post-procedure would have captured the impact of post-procedure dietary restrictions and any medical problems. Such data could be helpful in decision-making about the use of bariatric procedures in this population versus noninvasive approaches to management.

As the authors note, treating severe obesity in adolescence rather than waiting until adulthood may have significant implications for improved health in adulthood, particularly in preventing or reversing cardiovascular damage related to obesity-related cardiometabolic risk factors. However, what is not known yet is whether the positive outcomes, beginning with weight loss, are sustained through adulthood. This 3-year longitudinal study was the first to examine factors over an extended time period, however, considering the average life expectancy of an adolescent, it provides only a relatively short-term outlook. A longitudinal study that follows a cohort of adolescents from the time of the bariatric procedure into middle age or beyond is needed. Such a study would also provide needed information about the long-term consequences of repeated intraabdominal procedures and the persistence or resolution of micronutrient deficiencies and their effects on health.

The strengths of this study are its prospective longitudinal design and its high rate of cohort completion (99% of participants remained actively involved, completing 88% of follow-up visits). As the authors note, the lack of a control group of adolescents treated with diet and behavioral approaches prevents any definitive statement about the benefits and risks compared to nonsurgical approaches. However, previous research indicates that weight loss is not as great nor sustained when nonsurgical approaches are used.

Applications for Clinical Practice

The use of bariatric surgery in adolescents is a promising approach to a major health problem that has proven resistant to concerted medical and public health efforts and the use of nonsurgical treatments. Ongoing longitudinal research is needed but the positive outcomes seen here—sustained significant weight loss, improvement in cardiometabolic risk factors and comorbidities, and improved weight-related quality of life—indicate that bariatric surgery is an effective treatment for adolescent obesity when diet and behavioral approaches have failed. However, the occurrence of post-procedure complications also highlights the need for caution. Clinicians must carefully weigh the risk-benefit ratio for each individual, taking into consideration the long-term implications of severe obesity, any potential for significant weight loss with diet and behavioral changes, and the positive outcomes of bariatric surgery demonstrated here.

 —Karen Roush, PhD, RN

Study Overview

Objective. To examine the efficacy and safety of weight-loss surgery in adolescents.

Design. Prospective observational study.

Setting and participants. Adolescents (aged 13–19 years) with severe obesity undergoing bariatric surgery at 5 U.S. hospitals and medical centers from March 2007 through February 2012. Participants were enrolled in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study, a longitudinal prospective study that investigated the risks and benefits of adolescent bariatric surgery.

Main outcome measures. Data was collected on weight, comorbidities, cardiometabolic risk factors, nutritional status, and weight-related quality of life at research visits scheduled at 6 months, 1 year, 2 years, and 3 years post bariatric surgery. Researchers measured height and weight and blood pressure directly and calculated BMI. They assessed for comorbidities and cardiometabolic risk factors through urine and serum laboratory tests of lipids, glomerular filtration rate, albumin, glycated hemoglobin, fasting glucose level, and insulin. They assessed nutritional status with laboratory values for serum albumin, folate, vitamin B₁₂, 25-hydroxyvitamin D, parathyroid hormone, ferritin, transferrin, vitamin A, and vitamin B₁ erythrocyte transketolase. Researchers conducted interviews with the participants to collect information about subsequent medical or surgical procedures or, if participants missed a research visit, they obtained information through chart reviews. Finally, weight-related quality of life was assessed with the Impact of Weight on Quality of Life-Kids instrument, a validated self-report measure with 27 items divided into 4 subscales: physical comfort, body esteem, social life, and family relations.

Main results. Analysis was conducted on results for 228 of 242 participants who received Roux-en-Y gastric bypass (n = 161) and sleeve gastrectomy (n = 67). Results for 14 participants who received adjustable gastric banding were not included due to the small size of that group. Mean weight loss was 41 kg while mean height increased by only 0.51 cm. The mean percentage of weight loss was 27% overall and was similar in both groups, 28% in participants who underwent gastric bypass and 26% in those who underwent sleeve gastrectomy. At the 3-year visit, there were statistically significant improvements in comorbidities: 74% of the 96 participants with elevated blood pressure, 66% of the 171 participants with dyslipidemia, and 86% of the 36 participants with abnormal kidney function at baseline had values within the normal range. None of 3 participants with type 1 diabetes at baseline had resolution. However, 29 participants had type 2 diabetes (median glycolated hemoglobin 6.3% at baseline) and 19 of 20 of them for whom data were available at 3 years were in remission, with a median glycolated hemoglobin of 5.3%. There was an increase in the number of participants with micronutrient deficiencies at the 3-year mark: the percentage of participants with low ferritin levels increased from 5% at baseline to 57%, those with low vitamin B₁₂ increased from < 1% to 8%, and those with low vitamin A increased from 6% to 16%. During the 3-year follow-up period, 30 participants underwent 44 intrabdominal procedures related to the bariatric procedure and 29 participants underwent 48 endoscopic procedures, including stricture dilatation (n = 11). Total scores on the Impact of Weight on Quality of Life-Kids instrument improved from a mean of 63 at baseline to 83 at 3 years.

Conclusion. Overall there were significant improvements in weight, comorbidities, cardiometabolic health, and weight-related quality of life. However, there were also risks, including increased micronutrient deficiencies and the need for subsequent invasive abdominal procedures.

Commentary

Pediatric obesity is one of the most significant health problems facing children and adolescents. According to the most recent estimates, 34.5% of all adolescents aged 12 to 19 years are overweight or obese [1]. Pediatric obesity has serious short- and long-term psychosocial and physical implications. Obese adolescents suffer from social marginalization, poor self-concept, and lower health-related quality of life [2,3]. They are at greater risk for metabolic syndrome, diabetes, obstructive sleep apnea, and conditions associated with coronary artery disease such as hyperlipidemia and hypertension [4,5]. Additionally, obesity in adolescence is strongly associated with early mortality and years of life lost [6].

Despite extensive research and public health campaigns, rates of adolescent obesity have not decreased since 2003 [1]. Diet and behavioral approaches have had limited success and are rarely sustained over time. Bariatric surgery is an approach that has been used safely and effectively in severely obese adults and is increasingly being used for adolescents as well [7]. The results of this study are encouraging in that they suggest that bariatric surgery is effective in adolescents, leading to significant and sustained weight loss over 3 years and improved cardiometabolic health and weight-related quality of life.

The procedures are not without risks as demonstrated by the findings of micronutrient deficiencies and the need for follow-up intraabdominal and endoscopic procedures. The number of follow-up procedures and the fact that they continued into the third year is concerning. More details about this finding, such as characteristics of participants who required them, would be helpful. Further research to determine risk factors associated with complications that require subsequent invasive procedures is important for developing criteria for selection of candidates for bariatric surgery. Additionally, there was no information on impact of the follow-up procedures on participants or the conditions that precipitated them. In addition, there was no information on physical sequelae that can cause ongoing distress for patients, eg, chronic abdominal cramping and pain. The authors measured weight-related quality of life but measuring overall quality of life post-procedure would have captured the impact of post-procedure dietary restrictions and any medical problems. Such data could be helpful in decision-making about the use of bariatric procedures in this population versus noninvasive approaches to management.

As the authors note, treating severe obesity in adolescence rather than waiting until adulthood may have significant implications for improved health in adulthood, particularly in preventing or reversing cardiovascular damage related to obesity-related cardiometabolic risk factors. However, what is not known yet is whether the positive outcomes, beginning with weight loss, are sustained through adulthood. This 3-year longitudinal study was the first to examine factors over an extended time period, however, considering the average life expectancy of an adolescent, it provides only a relatively short-term outlook. A longitudinal study that follows a cohort of adolescents from the time of the bariatric procedure into middle age or beyond is needed. Such a study would also provide needed information about the long-term consequences of repeated intraabdominal procedures and the persistence or resolution of micronutrient deficiencies and their effects on health.

The strengths of this study are its prospective longitudinal design and its high rate of cohort completion (99% of participants remained actively involved, completing 88% of follow-up visits). As the authors note, the lack of a control group of adolescents treated with diet and behavioral approaches prevents any definitive statement about the benefits and risks compared to nonsurgical approaches. However, previous research indicates that weight loss is not as great nor sustained when nonsurgical approaches are used.

Applications for Clinical Practice

The use of bariatric surgery in adolescents is a promising approach to a major health problem that has proven resistant to concerted medical and public health efforts and the use of nonsurgical treatments. Ongoing longitudinal research is needed but the positive outcomes seen here—sustained significant weight loss, improvement in cardiometabolic risk factors and comorbidities, and improved weight-related quality of life—indicate that bariatric surgery is an effective treatment for adolescent obesity when diet and behavioral approaches have failed. However, the occurrence of post-procedure complications also highlights the need for caution. Clinicians must carefully weigh the risk-benefit ratio for each individual, taking into consideration the long-term implications of severe obesity, any potential for significant weight loss with diet and behavioral changes, and the positive outcomes of bariatric surgery demonstrated here.

 —Karen Roush, PhD, RN