Jennifer Bello Kottenstette, MD

PRACTICE CHANGER
Stop recommending omega-3 fatty acid supplements for cardiovascular protection. They have no significant impact on all-cause mortality, acute myocardial infarction (MI), sudden death, or stroke.¹

STRENGTH OF RECOMMENDATION
A: Based on a meta-analysis of randomized controlled trials (RCTs).

ILLUSTRATIVE CASE
A 59-year-old patient who had an MI three years ago is taking an ACE inhibitor, a statin, and a -blocker. He asks you whether he should also take omega-3 fatty acid supplements to further decrease his risk for heart disease. What should you tell him?

Coronary artery disease (CAD) kills more than 500,000 Americans every year,² and medical and dietary therapies for primary and secondary cardiovascular protection are paramount. Omega-3 polyunsaturated fatty acid (PUFA) supplementation is one such therapy.

Omega-3 PUFAs are precursors to certain prostaglandins that decrease the proinflammatory state in patients with CAD. They also lower triglyceride levels and produce an anti-arrhythmic effect by promoting electrical stability.

But do PUFA supplements ­provide cardioprotection?

The American Heart Association’s Nutrition Committee recommends either omega-3 PUFA supplementation with 250 to 500 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) per day or two servings of oily fish per week for both primary and secondary prevention of CAD.³ The European Society of Cardiology also encourages increased consumption of oily fish.⁴

These recommendations are based on primary and secondary prevention studies performed between 1989 and 2007, which found a 15% to 29% decrease in all-cause mortality and nonfatal cardiovascular events associated with regular intake of omega-3 fatty acids.^5-7 The systematic review and meta-analysis detailed below revisited the effect of omega-3 supplementation on major cardiovascular outcomes.¹

STUDY SUMMARY
Omega-3 supplements don’t lower cardiovascular risk

This meta-analysis included 20 RCTs with a total of 68,680 patients. The median age was 68, with a range of 49 to 70.  Thirteen of the studies evaluated omega-3 PUFAs for secondary prevention of cardiovascular outcomes, four assessed both primary and secondary prevention, and three looked at outcomes in patients with implantable cardioverter defibrillators. All lasted longer than one year, and most were high quality, with a low risk for bias.

The median treatment duration was two years, with a maximum of 6.2 years. The mean omega-3 PUFA dose evaluated in the studies was 1.5 g/d, with the exception of two studies in which patients received omega-3 PUFAs through dietary sources. Twelve studies used a dose of 1 g or more per day. Half of the included trials were performed during the period when statins were routinely prescribed for cardiovascular risk modification (1998 or later).

Outcomes included all-cause mortality (17 studies), cardiac death (13 studies), sudden death (seven studies), MI (13 studies), and stroke (nine studies).

This meta-analysis found trends toward a decrease in all-cause mortality, cardiac death, sudden death, and MI in patients taking omega-3 PUFAs, but no statistically significant association between any of the outcomes and omega-3 PUFA supplementation. The relative risk for all-cause mortality was 0.96. Prespecified subgroup analysis found no association between treatment effect and omega-3 fatty acid dose.

Are dietary sources of omega-3s more effective?

In the two trials that involved dietary supplementation with omega-3 PUFAs, the results for all-cause mortality and cardiac death were conflicting, with one showing an increase in all-cause mortality and cardiac death and the other showing a decrease in both outcomes compared with the control group.

No harmful effects of omega-3 PUFAs were found in either the supplement- or diet-based studies.

WHAT’S NEW
More evidence of little benefit

The meta-analysis by Rizos et al is the most up-to-date, comprehensive look at the value of omega-3 fatty acids for primary and secondary prevention of cardiovascular events. It differs from previous reviews in that most of the included studies were well-done RCTs.

In addition, the studies were performed in both primary and secondary cardiovascular disease prevention settings and involved different forms of omega-3 PUFA supplementation, including dietary sources and supplements. The trials were predominantly larger than those included in previous systematic reviews, as well. The baseline risk for cardiovascular disease in the newer studies (seven of the 20 RCTs were completed after 2007) may be different from that of previous studies because of increased use of certain medications, such as statins.

In recent years, other studies of omega-3 PUFAs have had similar results. A meta-analysis of 14 RCTs found that omega-3 PUFA supplementation offered no benefit for the secondary prevention of cardiovascular disease.⁸ The FORWARD trial—published earlier this year—showed that omega-3 PUFAs did not decrease the recurrence of atrial fibrillation in patients with a history of confirmed paroxysmal atrial fibrillation.⁹ And an earlier (2006) analysis of RCTs and cohort studies found no benefit from omega-3 fatty acids for primary prevention of cardiovascular disease or cancer.¹⁰

CAVEATS
No significant help, and no harm

While this meta-analysis found no statistically significant benefits from omega-3 PUFAs, there is no evidence of harm from PUFA intake, whether from dietary sources or supplements. There is no need to tell patients who wish to take omega-3 supplements not to do so. But we should not promote their use for the sole purpose of cardiovascular disease prevention.

CHALLENGES TO IMPLEMENTATION
Changing minds won’t be easy

Despite recent findings indicating that omega-3 PUFAs provide little primary or secondary protection against cardiovascular events, advertising from supplement manufacturers may make it hard to change patients’ minds. Because diets and supplements containing these fatty acids do not cause apparent harm, patients and clinicians may decide that a small potential benefit is worth the expense.

References

1. Rizos E, Ntzani E, Bika E, et al. Association between omega-3 fatty acid supplementation and risk of major cardiovascular disease events: a systemic review and meta-analysis. JAMA. 2012; 308:1024-1033.

2. CDC. FastStats. Deaths and mortality. 2010 [updated April 5, 2013]. www.cdc.gov/nchs/fastats/deaths.htm. Accessed July 21, 2013.

3. Kris-Etherton PM, Harris WS, Appel LJ, et al. Fish consumption, fish oil, omega-3 fatty acids and cardiovascular disease. Circulation. 2002;106:2747-2757.

4. Van de Werf F, Bax J, Betriu A, et al. Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008;29:2909-2945.

5. Artham SM, Lavie CJ, Milani RV, et al. Fish oil in primary and secondary cardiovascular prevention. Ochsner J. 2008;8: 49-60.

6. Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto miocardico. Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of GISSI-Prevenzione trial. Lancet. 1999; 354:447-455.

7. Yokoyama M, Origasa H, Matsuzaki M, et al. Effects of eicosapentaenoic acid on major coronary events in hypercholesteroleamic patients (JELIS): a randomized open-label, blinded endpoint analysis. Lancet. 2007;369:1090-1098.

8. Kwak SM, Myung SK, Lee YJ, et al. Efficacy of omega-3 fatty acid supplements (eicosapentaenoic acid and docosahexaenoic acid) in the secondary prevention of cardiovascular disease: a meta-analysis of randomized, double-blind, placebo-controlled trials. Arch Intern Med. 2012;172: 686-694.

9. Macchia A, Grancelli H, Varini S, et al. Omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: results of the FORWARD (Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation) trial. J Am Coll Cardiol. 2013;61:463-468.

10. Hooper L, Thompson RL, Harrison RA, et al. Risks and benefits of omega 3 fats for mortality, cardiovascular disease, and cancer: systemic review. BMJ. 2006;332:752-760.

Acknowledgement

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.

Copyright © 2013. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice. 2013;62(7):372-374.

PRACTICE CHANGER
Stop recommending omega-3 fatty acid supplements for cardiovascular protection. They have no significant impact on all-cause mortality, acute myocardial infarction (MI), sudden death, or stroke.¹

STRENGTH OF RECOMMENDATION
A: Based on a meta-analysis of randomized controlled trials (RCTs).

ILLUSTRATIVE CASE
A 59-year-old patient who had an MI three years ago is taking an ACE inhibitor, a statin, and a -blocker. He asks you whether he should also take omega-3 fatty acid supplements to further decrease his risk for heart disease. What should you tell him?

Coronary artery disease (CAD) kills more than 500,000 Americans every year,² and medical and dietary therapies for primary and secondary cardiovascular protection are paramount. Omega-3 polyunsaturated fatty acid (PUFA) supplementation is one such therapy.

Omega-3 PUFAs are precursors to certain prostaglandins that decrease the proinflammatory state in patients with CAD. They also lower triglyceride levels and produce an anti-arrhythmic effect by promoting electrical stability.

But do PUFA supplements ­provide cardioprotection?

The American Heart Association’s Nutrition Committee recommends either omega-3 PUFA supplementation with 250 to 500 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) per day or two servings of oily fish per week for both primary and secondary prevention of CAD.³ The European Society of Cardiology also encourages increased consumption of oily fish.⁴

These recommendations are based on primary and secondary prevention studies performed between 1989 and 2007, which found a 15% to 29% decrease in all-cause mortality and nonfatal cardiovascular events associated with regular intake of omega-3 fatty acids.^5-7 The systematic review and meta-analysis detailed below revisited the effect of omega-3 supplementation on major cardiovascular outcomes.¹

STUDY SUMMARY
Omega-3 supplements don’t lower cardiovascular risk

This meta-analysis included 20 RCTs with a total of 68,680 patients. The median age was 68, with a range of 49 to 70.  Thirteen of the studies evaluated omega-3 PUFAs for secondary prevention of cardiovascular outcomes, four assessed both primary and secondary prevention, and three looked at outcomes in patients with implantable cardioverter defibrillators. All lasted longer than one year, and most were high quality, with a low risk for bias.

The median treatment duration was two years, with a maximum of 6.2 years. The mean omega-3 PUFA dose evaluated in the studies was 1.5 g/d, with the exception of two studies in which patients received omega-3 PUFAs through dietary sources. Twelve studies used a dose of 1 g or more per day. Half of the included trials were performed during the period when statins were routinely prescribed for cardiovascular risk modification (1998 or later).

Outcomes included all-cause mortality (17 studies), cardiac death (13 studies), sudden death (seven studies), MI (13 studies), and stroke (nine studies).

This meta-analysis found trends toward a decrease in all-cause mortality, cardiac death, sudden death, and MI in patients taking omega-3 PUFAs, but no statistically significant association between any of the outcomes and omega-3 PUFA supplementation. The relative risk for all-cause mortality was 0.96. Prespecified subgroup analysis found no association between treatment effect and omega-3 fatty acid dose.

Are dietary sources of omega-3s more effective?

In the two trials that involved dietary supplementation with omega-3 PUFAs, the results for all-cause mortality and cardiac death were conflicting, with one showing an increase in all-cause mortality and cardiac death and the other showing a decrease in both outcomes compared with the control group.

No harmful effects of omega-3 PUFAs were found in either the supplement- or diet-based studies.

WHAT’S NEW
More evidence of little benefit

The meta-analysis by Rizos et al is the most up-to-date, comprehensive look at the value of omega-3 fatty acids for primary and secondary prevention of cardiovascular events. It differs from previous reviews in that most of the included studies were well-done RCTs.

In addition, the studies were performed in both primary and secondary cardiovascular disease prevention settings and involved different forms of omega-3 PUFA supplementation, including dietary sources and supplements. The trials were predominantly larger than those included in previous systematic reviews, as well. The baseline risk for cardiovascular disease in the newer studies (seven of the 20 RCTs were completed after 2007) may be different from that of previous studies because of increased use of certain medications, such as statins.

In recent years, other studies of omega-3 PUFAs have had similar results. A meta-analysis of 14 RCTs found that omega-3 PUFA supplementation offered no benefit for the secondary prevention of cardiovascular disease.⁸ The FORWARD trial—published earlier this year—showed that omega-3 PUFAs did not decrease the recurrence of atrial fibrillation in patients with a history of confirmed paroxysmal atrial fibrillation.⁹ And an earlier (2006) analysis of RCTs and cohort studies found no benefit from omega-3 fatty acids for primary prevention of cardiovascular disease or cancer.¹⁰

CAVEATS
No significant help, and no harm

While this meta-analysis found no statistically significant benefits from omega-3 PUFAs, there is no evidence of harm from PUFA intake, whether from dietary sources or supplements. There is no need to tell patients who wish to take omega-3 supplements not to do so. But we should not promote their use for the sole purpose of cardiovascular disease prevention.

CHALLENGES TO IMPLEMENTATION
Changing minds won’t be easy

Despite recent findings indicating that omega-3 PUFAs provide little primary or secondary protection against cardiovascular events, advertising from supplement manufacturers may make it hard to change patients’ minds. Because diets and supplements containing these fatty acids do not cause apparent harm, patients and clinicians may decide that a small potential benefit is worth the expense.

References

1. Rizos E, Ntzani E, Bika E, et al. Association between omega-3 fatty acid supplementation and risk of major cardiovascular disease events: a systemic review and meta-analysis. JAMA. 2012; 308:1024-1033.

2. CDC. FastStats. Deaths and mortality. 2010 [updated April 5, 2013]. www.cdc.gov/nchs/fastats/deaths.htm. Accessed July 21, 2013.

3. Kris-Etherton PM, Harris WS, Appel LJ, et al. Fish consumption, fish oil, omega-3 fatty acids and cardiovascular disease. Circulation. 2002;106:2747-2757.

4. Van de Werf F, Bax J, Betriu A, et al. Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008;29:2909-2945.

5. Artham SM, Lavie CJ, Milani RV, et al. Fish oil in primary and secondary cardiovascular prevention. Ochsner J. 2008;8: 49-60.

6. Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto miocardico. Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of GISSI-Prevenzione trial. Lancet. 1999; 354:447-455.

7. Yokoyama M, Origasa H, Matsuzaki M, et al. Effects of eicosapentaenoic acid on major coronary events in hypercholesteroleamic patients (JELIS): a randomized open-label, blinded endpoint analysis. Lancet. 2007;369:1090-1098.

8. Kwak SM, Myung SK, Lee YJ, et al. Efficacy of omega-3 fatty acid supplements (eicosapentaenoic acid and docosahexaenoic acid) in the secondary prevention of cardiovascular disease: a meta-analysis of randomized, double-blind, placebo-controlled trials. Arch Intern Med. 2012;172: 686-694.

9. Macchia A, Grancelli H, Varini S, et al. Omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: results of the FORWARD (Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation) trial. J Am Coll Cardiol. 2013;61:463-468.

10. Hooper L, Thompson RL, Harrison RA, et al. Risks and benefits of omega 3 fats for mortality, cardiovascular disease, and cancer: systemic review. BMJ. 2006;332:752-760.

Acknowledgement

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.

Copyright © 2013. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice. 2013;62(7):372-374.

PRACTICE CHANGER
Stop recommending omega-3 fatty acid supplements for cardiovascular protection. They have no significant impact on all-cause mortality, acute myocardial infarction (MI), sudden death, or stroke.¹

STRENGTH OF RECOMMENDATION
A: Based on a meta-analysis of randomized controlled trials (RCTs).

ILLUSTRATIVE CASE
A 59-year-old patient who had an MI three years ago is taking an ACE inhibitor, a statin, and a -blocker. He asks you whether he should also take omega-3 fatty acid supplements to further decrease his risk for heart disease. What should you tell him?

Coronary artery disease (CAD) kills more than 500,000 Americans every year,² and medical and dietary therapies for primary and secondary cardiovascular protection are paramount. Omega-3 polyunsaturated fatty acid (PUFA) supplementation is one such therapy.

Omega-3 PUFAs are precursors to certain prostaglandins that decrease the proinflammatory state in patients with CAD. They also lower triglyceride levels and produce an anti-arrhythmic effect by promoting electrical stability.

But do PUFA supplements ­provide cardioprotection?

The American Heart Association’s Nutrition Committee recommends either omega-3 PUFA supplementation with 250 to 500 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) per day or two servings of oily fish per week for both primary and secondary prevention of CAD.³ The European Society of Cardiology also encourages increased consumption of oily fish.⁴

These recommendations are based on primary and secondary prevention studies performed between 1989 and 2007, which found a 15% to 29% decrease in all-cause mortality and nonfatal cardiovascular events associated with regular intake of omega-3 fatty acids.^5-7 The systematic review and meta-analysis detailed below revisited the effect of omega-3 supplementation on major cardiovascular outcomes.¹

STUDY SUMMARY
Omega-3 supplements don’t lower cardiovascular risk

This meta-analysis included 20 RCTs with a total of 68,680 patients. The median age was 68, with a range of 49 to 70.  Thirteen of the studies evaluated omega-3 PUFAs for secondary prevention of cardiovascular outcomes, four assessed both primary and secondary prevention, and three looked at outcomes in patients with implantable cardioverter defibrillators. All lasted longer than one year, and most were high quality, with a low risk for bias.

The median treatment duration was two years, with a maximum of 6.2 years. The mean omega-3 PUFA dose evaluated in the studies was 1.5 g/d, with the exception of two studies in which patients received omega-3 PUFAs through dietary sources. Twelve studies used a dose of 1 g or more per day. Half of the included trials were performed during the period when statins were routinely prescribed for cardiovascular risk modification (1998 or later).

Outcomes included all-cause mortality (17 studies), cardiac death (13 studies), sudden death (seven studies), MI (13 studies), and stroke (nine studies).

This meta-analysis found trends toward a decrease in all-cause mortality, cardiac death, sudden death, and MI in patients taking omega-3 PUFAs, but no statistically significant association between any of the outcomes and omega-3 PUFA supplementation. The relative risk for all-cause mortality was 0.96. Prespecified subgroup analysis found no association between treatment effect and omega-3 fatty acid dose.

Are dietary sources of omega-3s more effective?

In the two trials that involved dietary supplementation with omega-3 PUFAs, the results for all-cause mortality and cardiac death were conflicting, with one showing an increase in all-cause mortality and cardiac death and the other showing a decrease in both outcomes compared with the control group.

No harmful effects of omega-3 PUFAs were found in either the supplement- or diet-based studies.

WHAT’S NEW
More evidence of little benefit

The meta-analysis by Rizos et al is the most up-to-date, comprehensive look at the value of omega-3 fatty acids for primary and secondary prevention of cardiovascular events. It differs from previous reviews in that most of the included studies were well-done RCTs.

In addition, the studies were performed in both primary and secondary cardiovascular disease prevention settings and involved different forms of omega-3 PUFA supplementation, including dietary sources and supplements. The trials were predominantly larger than those included in previous systematic reviews, as well. The baseline risk for cardiovascular disease in the newer studies (seven of the 20 RCTs were completed after 2007) may be different from that of previous studies because of increased use of certain medications, such as statins.

In recent years, other studies of omega-3 PUFAs have had similar results. A meta-analysis of 14 RCTs found that omega-3 PUFA supplementation offered no benefit for the secondary prevention of cardiovascular disease.⁸ The FORWARD trial—published earlier this year—showed that omega-3 PUFAs did not decrease the recurrence of atrial fibrillation in patients with a history of confirmed paroxysmal atrial fibrillation.⁹ And an earlier (2006) analysis of RCTs and cohort studies found no benefit from omega-3 fatty acids for primary prevention of cardiovascular disease or cancer.¹⁰

CAVEATS
No significant help, and no harm

While this meta-analysis found no statistically significant benefits from omega-3 PUFAs, there is no evidence of harm from PUFA intake, whether from dietary sources or supplements. There is no need to tell patients who wish to take omega-3 supplements not to do so. But we should not promote their use for the sole purpose of cardiovascular disease prevention.

CHALLENGES TO IMPLEMENTATION
Changing minds won’t be easy

Despite recent findings indicating that omega-3 PUFAs provide little primary or secondary protection against cardiovascular events, advertising from supplement manufacturers may make it hard to change patients’ minds. Because diets and supplements containing these fatty acids do not cause apparent harm, patients and clinicians may decide that a small potential benefit is worth the expense.

References

1. Rizos E, Ntzani E, Bika E, et al. Association between omega-3 fatty acid supplementation and risk of major cardiovascular disease events: a systemic review and meta-analysis. JAMA. 2012; 308:1024-1033.

2. CDC. FastStats. Deaths and mortality. 2010 [updated April 5, 2013]. www.cdc.gov/nchs/fastats/deaths.htm. Accessed July 21, 2013.

3. Kris-Etherton PM, Harris WS, Appel LJ, et al. Fish consumption, fish oil, omega-3 fatty acids and cardiovascular disease. Circulation. 2002;106:2747-2757.

4. Van de Werf F, Bax J, Betriu A, et al. Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008;29:2909-2945.

5. Artham SM, Lavie CJ, Milani RV, et al. Fish oil in primary and secondary cardiovascular prevention. Ochsner J. 2008;8: 49-60.

6. Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto miocardico. Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of GISSI-Prevenzione trial. Lancet. 1999; 354:447-455.

7. Yokoyama M, Origasa H, Matsuzaki M, et al. Effects of eicosapentaenoic acid on major coronary events in hypercholesteroleamic patients (JELIS): a randomized open-label, blinded endpoint analysis. Lancet. 2007;369:1090-1098.

8. Kwak SM, Myung SK, Lee YJ, et al. Efficacy of omega-3 fatty acid supplements (eicosapentaenoic acid and docosahexaenoic acid) in the secondary prevention of cardiovascular disease: a meta-analysis of randomized, double-blind, placebo-controlled trials. Arch Intern Med. 2012;172: 686-694.

9. Macchia A, Grancelli H, Varini S, et al. Omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: results of the FORWARD (Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation) trial. J Am Coll Cardiol. 2013;61:463-468.

10. Hooper L, Thompson RL, Harrison RA, et al. Risks and benefits of omega 3 fats for mortality, cardiovascular disease, and cancer: systemic review. BMJ. 2006;332:752-760.

Acknowledgement

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.

Copyright © 2013. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice. 2013;62(7):372-374.

ILLUSTRATIVE CASE

A 59–year-old patient who had a myocardial infarction (mi) 3 years ago is taking an ace inhibitor, a statin, and a b-blocker. He asks you whether he should also take omega-3 fatty acid supplements to further decrease his risk of heart disease. What should you tell him?

Coronary artery disease (CAD) kills more than 500,000 Americans every year², and medical and dietary therapies for primary and secondary cardiovascular protection are paramount. Omega-3 polyunsaturated fatty acid (PUFA) supplementation is one such therapy. Omega-3 PUFAs are precursors to certain prostaglandins that decrease the proinflammatory state in patients with CAD. They also lower triglyceride levels and produce an antiarrhythmic effect by promoting electrical stability.

But do PUFA supplements provide cardioprotection?
The American Heart Association’s Nutrition Committee recommends either omega-3 PUFA supplementation with 250 to 500 mg eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) per day or 2 servings of oily fish per week for both primary and secondary prevention of CAD.³ The European Society of Cardiology also encourages increased consumption of oily fish.⁴

These recommendations are based on primary and secondary prevention studies, performed between 1989 and 2007, that found a 15% to 29% decrease in all-cause mortality and nonfatal cardiovascular events associated with regular intake of omega-3 fatty acids.^5-7 The systematic review and meta-analysis detailed below revisited the effect of omega-3 supplementation on major cardiovascular outcomes.¹

STUDY SUMMARY: Omega-3 supplements don’t lower cardiovascular risk

This meta-analysis included 20 RCTs with a total of 68,680 patients. The median age was 68 years, with a range from 49 to 70 years. Thirteen of the studies evaluated omega-3 PUFAs for secondary prevention of cardiovascular outcomes, 4 assessed both primary and secondary prevention, and 3 looked at outcomes in patients with implantable cardioverter defibrillators. All lasted longer than one year, and most were high quality, with a low risk of bias.

The median treatment duration was 2 years, with a maximum of 6.2 years. The mean omega-3 PUFA dose evaluated in the studies was 1.5 g per day, with the exception of 2 studies in which patients received omega-3 PUFAs through dietary sources. Twelve studies used a dose of 1 g or more per day. Half of the included trials were performed during the period when statins were routinely prescribed for cardiovascular risk modification (1998 or later).

Outcomes included all-cause mortality (17 studies), cardiac death (13 studies), sudden death (7 studies), MI (13 studies), and stroke (9 studies).

This meta-analysis found trends toward a decrease in all-cause mortality, cardiac death, sudden death, and MI in patients taking omega-3 PUFAs, but no statistically significant association between any of the outcomes and omega-3 PUFA supplementation. The relative risk for all-cause mortality was 0.96 (95% confidence interval, 0.91-1.02; P=.17). Prespecified subgroup analysis found no association between treatment effect and omega-3 fatty acid dose.

Are dietary sources of omega-3s more effective?
In the 2 trials involving dietary supplementation with omega-3 PUFAs, the results for all-cause mortality and cardiac death were conflicting, with one showing an increase in all-cause mortality and cardiac death and the other showing a decrease in both outcomes compared with the control group. No harmful effects of omega-3 PUFAs were found in either the supplement- or diet-based studies. 

WHAT’S NEW: More evidence of little benefit 

The meta-analysis by Rizos et al is the most up-to-date, comprehensive look at the value of omega-3 fatty acids for primary and secondary prevention of cardiovascular events.It differs from previous reviews in that most included studies were well-done RCTs. In addition, the studies were performed in both primary and secondary cardiovascular disease prevention settings and involved different forms of omega-3 PUFA supplementation, including dietary sources and supplements. The trials were predominantly larger than those included in previous systematic reviews, as well. The baseline risk for cardiovascular disease in the newer studies (7 of the 20 RCTs were completed after 2007) may be different from that of previous studies because of increased use of certain medications,such as statins. In recent years, other studies of omega-3 PUFAs have had similar results. A metaanalysis of 14 RCTs found that omega-3 PUFA supplementation offered no benefit for the secondary prevention of cardiovascular disease.⁸ The FORWARD trial—published earlier this year—showed that omega-3 PUFAs did not decrease the recurrence of atrial fibrillationin patients with a history of confirmed paroxysmal atrial fibrillation.⁹ And an earlier(2006) analysis of RCTs and cohort studies found no benefit from omega-3 fatty acids for primary prevention of cardiovascular disease or cancer.¹⁰

CAVEATS: No significant help, and no harm

There’s no need to tell patients who wish to take omega-3 supplements not to do so, but we should not promote their use for the sole purpose of cardiovascular disease protection.

While this meta-analysis found no statistically significant benefits from omega-3 PUFAs, there is no evidence of harm from PUFA intake, whether from dietary sources or supplements. There is no need to tell patients who wish to take omega-3 supplements not to do so. But we should not promote their use for the sole purpose of cardiovascular disease prevention.

CHALLENGES TO IMPLEMENTATION: Changing minds won’t be easy

Despite recent findings indicating that omega-3 PUFAs provide little primary or secondary protection against cardiovascular events, advertising from supplement manufacturers may make it hard to change patients’ minds. Because diets and supplements containing these fatty acids do not cause apparent harm, patients and physicians may decide that a small potential benefit is worth the expense.

Acknowledgement

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A 59–year-old patient who had a myocardial infarction (mi) 3 years ago is taking an ace inhibitor, a statin, and a b-blocker. He asks you whether he should also take omega-3 fatty acid supplements to further decrease his risk of heart disease. What should you tell him?

Coronary artery disease (CAD) kills more than 500,000 Americans every year², and medical and dietary therapies for primary and secondary cardiovascular protection are paramount. Omega-3 polyunsaturated fatty acid (PUFA) supplementation is one such therapy. Omega-3 PUFAs are precursors to certain prostaglandins that decrease the proinflammatory state in patients with CAD. They also lower triglyceride levels and produce an antiarrhythmic effect by promoting electrical stability.

But do PUFA supplements provide cardioprotection?
The American Heart Association’s Nutrition Committee recommends either omega-3 PUFA supplementation with 250 to 500 mg eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) per day or 2 servings of oily fish per week for both primary and secondary prevention of CAD.³ The European Society of Cardiology also encourages increased consumption of oily fish.⁴

These recommendations are based on primary and secondary prevention studies, performed between 1989 and 2007, that found a 15% to 29% decrease in all-cause mortality and nonfatal cardiovascular events associated with regular intake of omega-3 fatty acids.^5-7 The systematic review and meta-analysis detailed below revisited the effect of omega-3 supplementation on major cardiovascular outcomes.¹

STUDY SUMMARY: Omega-3 supplements don’t lower cardiovascular risk

This meta-analysis included 20 RCTs with a total of 68,680 patients. The median age was 68 years, with a range from 49 to 70 years. Thirteen of the studies evaluated omega-3 PUFAs for secondary prevention of cardiovascular outcomes, 4 assessed both primary and secondary prevention, and 3 looked at outcomes in patients with implantable cardioverter defibrillators. All lasted longer than one year, and most were high quality, with a low risk of bias.

The median treatment duration was 2 years, with a maximum of 6.2 years. The mean omega-3 PUFA dose evaluated in the studies was 1.5 g per day, with the exception of 2 studies in which patients received omega-3 PUFAs through dietary sources. Twelve studies used a dose of 1 g or more per day. Half of the included trials were performed during the period when statins were routinely prescribed for cardiovascular risk modification (1998 or later).

Outcomes included all-cause mortality (17 studies), cardiac death (13 studies), sudden death (7 studies), MI (13 studies), and stroke (9 studies).

This meta-analysis found trends toward a decrease in all-cause mortality, cardiac death, sudden death, and MI in patients taking omega-3 PUFAs, but no statistically significant association between any of the outcomes and omega-3 PUFA supplementation. The relative risk for all-cause mortality was 0.96 (95% confidence interval, 0.91-1.02; P=.17). Prespecified subgroup analysis found no association between treatment effect and omega-3 fatty acid dose.

Are dietary sources of omega-3s more effective?
In the 2 trials involving dietary supplementation with omega-3 PUFAs, the results for all-cause mortality and cardiac death were conflicting, with one showing an increase in all-cause mortality and cardiac death and the other showing a decrease in both outcomes compared with the control group. No harmful effects of omega-3 PUFAs were found in either the supplement- or diet-based studies. 

WHAT’S NEW: More evidence of little benefit 

The meta-analysis by Rizos et al is the most up-to-date, comprehensive look at the value of omega-3 fatty acids for primary and secondary prevention of cardiovascular events.It differs from previous reviews in that most included studies were well-done RCTs. In addition, the studies were performed in both primary and secondary cardiovascular disease prevention settings and involved different forms of omega-3 PUFA supplementation, including dietary sources and supplements. The trials were predominantly larger than those included in previous systematic reviews, as well. The baseline risk for cardiovascular disease in the newer studies (7 of the 20 RCTs were completed after 2007) may be different from that of previous studies because of increased use of certain medications,such as statins. In recent years, other studies of omega-3 PUFAs have had similar results. A metaanalysis of 14 RCTs found that omega-3 PUFA supplementation offered no benefit for the secondary prevention of cardiovascular disease.⁸ The FORWARD trial—published earlier this year—showed that omega-3 PUFAs did not decrease the recurrence of atrial fibrillationin patients with a history of confirmed paroxysmal atrial fibrillation.⁹ And an earlier(2006) analysis of RCTs and cohort studies found no benefit from omega-3 fatty acids for primary prevention of cardiovascular disease or cancer.¹⁰

CAVEATS: No significant help, and no harm

There’s no need to tell patients who wish to take omega-3 supplements not to do so, but we should not promote their use for the sole purpose of cardiovascular disease protection.

While this meta-analysis found no statistically significant benefits from omega-3 PUFAs, there is no evidence of harm from PUFA intake, whether from dietary sources or supplements. There is no need to tell patients who wish to take omega-3 supplements not to do so. But we should not promote their use for the sole purpose of cardiovascular disease prevention.

CHALLENGES TO IMPLEMENTATION: Changing minds won’t be easy

Despite recent findings indicating that omega-3 PUFAs provide little primary or secondary protection against cardiovascular events, advertising from supplement manufacturers may make it hard to change patients’ minds. Because diets and supplements containing these fatty acids do not cause apparent harm, patients and physicians may decide that a small potential benefit is worth the expense.

Acknowledgement

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A 59–year-old patient who had a myocardial infarction (mi) 3 years ago is taking an ace inhibitor, a statin, and a b-blocker. He asks you whether he should also take omega-3 fatty acid supplements to further decrease his risk of heart disease. What should you tell him?

Coronary artery disease (CAD) kills more than 500,000 Americans every year², and medical and dietary therapies for primary and secondary cardiovascular protection are paramount. Omega-3 polyunsaturated fatty acid (PUFA) supplementation is one such therapy. Omega-3 PUFAs are precursors to certain prostaglandins that decrease the proinflammatory state in patients with CAD. They also lower triglyceride levels and produce an antiarrhythmic effect by promoting electrical stability.

But do PUFA supplements provide cardioprotection?
The American Heart Association’s Nutrition Committee recommends either omega-3 PUFA supplementation with 250 to 500 mg eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) per day or 2 servings of oily fish per week for both primary and secondary prevention of CAD.³ The European Society of Cardiology also encourages increased consumption of oily fish.⁴

These recommendations are based on primary and secondary prevention studies, performed between 1989 and 2007, that found a 15% to 29% decrease in all-cause mortality and nonfatal cardiovascular events associated with regular intake of omega-3 fatty acids.^5-7 The systematic review and meta-analysis detailed below revisited the effect of omega-3 supplementation on major cardiovascular outcomes.¹

STUDY SUMMARY: Omega-3 supplements don’t lower cardiovascular risk

This meta-analysis included 20 RCTs with a total of 68,680 patients. The median age was 68 years, with a range from 49 to 70 years. Thirteen of the studies evaluated omega-3 PUFAs for secondary prevention of cardiovascular outcomes, 4 assessed both primary and secondary prevention, and 3 looked at outcomes in patients with implantable cardioverter defibrillators. All lasted longer than one year, and most were high quality, with a low risk of bias.

The median treatment duration was 2 years, with a maximum of 6.2 years. The mean omega-3 PUFA dose evaluated in the studies was 1.5 g per day, with the exception of 2 studies in which patients received omega-3 PUFAs through dietary sources. Twelve studies used a dose of 1 g or more per day. Half of the included trials were performed during the period when statins were routinely prescribed for cardiovascular risk modification (1998 or later).

Outcomes included all-cause mortality (17 studies), cardiac death (13 studies), sudden death (7 studies), MI (13 studies), and stroke (9 studies).

This meta-analysis found trends toward a decrease in all-cause mortality, cardiac death, sudden death, and MI in patients taking omega-3 PUFAs, but no statistically significant association between any of the outcomes and omega-3 PUFA supplementation. The relative risk for all-cause mortality was 0.96 (95% confidence interval, 0.91-1.02; P=.17). Prespecified subgroup analysis found no association between treatment effect and omega-3 fatty acid dose.

Are dietary sources of omega-3s more effective?
In the 2 trials involving dietary supplementation with omega-3 PUFAs, the results for all-cause mortality and cardiac death were conflicting, with one showing an increase in all-cause mortality and cardiac death and the other showing a decrease in both outcomes compared with the control group. No harmful effects of omega-3 PUFAs were found in either the supplement- or diet-based studies. 

WHAT’S NEW: More evidence of little benefit 

The meta-analysis by Rizos et al is the most up-to-date, comprehensive look at the value of omega-3 fatty acids for primary and secondary prevention of cardiovascular events.It differs from previous reviews in that most included studies were well-done RCTs. In addition, the studies were performed in both primary and secondary cardiovascular disease prevention settings and involved different forms of omega-3 PUFA supplementation, including dietary sources and supplements. The trials were predominantly larger than those included in previous systematic reviews, as well. The baseline risk for cardiovascular disease in the newer studies (7 of the 20 RCTs were completed after 2007) may be different from that of previous studies because of increased use of certain medications,such as statins. In recent years, other studies of omega-3 PUFAs have had similar results. A metaanalysis of 14 RCTs found that omega-3 PUFA supplementation offered no benefit for the secondary prevention of cardiovascular disease.⁸ The FORWARD trial—published earlier this year—showed that omega-3 PUFAs did not decrease the recurrence of atrial fibrillationin patients with a history of confirmed paroxysmal atrial fibrillation.⁹ And an earlier(2006) analysis of RCTs and cohort studies found no benefit from omega-3 fatty acids for primary prevention of cardiovascular disease or cancer.¹⁰

CAVEATS: No significant help, and no harm

There’s no need to tell patients who wish to take omega-3 supplements not to do so, but we should not promote their use for the sole purpose of cardiovascular disease protection.

While this meta-analysis found no statistically significant benefits from omega-3 PUFAs, there is no evidence of harm from PUFA intake, whether from dietary sources or supplements. There is no need to tell patients who wish to take omega-3 supplements not to do so. But we should not promote their use for the sole purpose of cardiovascular disease prevention.

CHALLENGES TO IMPLEMENTATION: Changing minds won’t be easy

Despite recent findings indicating that omega-3 PUFAs provide little primary or secondary protection against cardiovascular events, advertising from supplement manufacturers may make it hard to change patients’ minds. Because diets and supplements containing these fatty acids do not cause apparent harm, patients and physicians may decide that a small potential benefit is worth the expense.

Acknowledgement

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.

PRACTICE CHANGER
Use a validated tool to screen women of childbearing age for intimate partner violence (IPV) and follow up with any woman with a positive screen.¹

STRENGTH OF RECOMMENDATION
B: Based on a systematic review of 10 randomized controlled trials (RCTs), 11 prospective cohort and cross-sectional studies, and 13 diagnostic accuracy studies.

ILLUSTRATIVE CASE
A healthy 27-year-old woman schedules a visit to discuss birth control options. Should you screen her for IPV, and if so, what instrument should you use?

Each year in the United States, an estimated 5.3 million women ages 18 and older are affected by IPV, resulting in nearly 2 million injuries and more than $4 billion in direct medical and mental health costs.² In addition to the immediate effects, which include death as well as injuries from physical and sexual assault,² IPV has long-term consequences, such as chronic physical and mental illness and substance abuse.³

Too little evidence of benefit?
In 2011, the Institute of Medicine (IOM) recommended for the first time that all women of childbearing age be screened for IPV and identified IPV screening as one of a number of preventive services that are important to women’s health.⁴ The IOM’s recommendation is in line with positions held by the American Medical Association’s National Advisory Council on Violence and Abuse⁵ and the American College of Obstetrics and Gynecology.⁶ These recommendations differ from that of the US Preventive Services Task Force (USPSTF), which determined in 2004 that there was insufficient evidence for or against screening women for IPV.⁷ In issuing its I rating, the USPSTF cited a lack of studies evaluating the accuracy of screening tools for identifying IPV and a lack of evidence as to whether interventions lead to a reduction in harm.

The 2012 systematic review detailed below was undertaken on behalf of the USPSTF to assess the latest evidence and update its recommendation. The USPSTF and the Agency for Healthcare Research and Quality (AHRQ) determined the focus and scope of the review.

STUDY SUMMARY
USPSTF issues a B recommendation for IPV screening
Thirty-four studies of women who sought care in either primary care settings or emergency departments (EDs) but had no complaints related to IPV were included in the review, which addressed four key questions.

Question 1: Does screening women for current, past, or increased risk for IPV reduce exposure to IPV, morbidity, or mortality? No, according to one large RCT whose validity was compromised by high dropout rates. The researchers reviewed a multicenter RCT with 6,743 participants ages 18 to 64 to answer that question. (The study was deemed to be of fair quality because of the high percentage of dropouts from both the screened and unscreened groups.)

The women, recruited from primary care, acute care, and obstetrics and gynecology clinics in Canada, were randomly assigned to either screening with the Woman Abuse Screening Tool (WAST)—an eight-question, self-administered and validated tool—or no screening. Primary outcomes were exposure to abuse and quality of life in the 18 months after screening; secondary outcomes included both mental and physical ailments.

Those in the intervention group underwent screening before seeing their clinicians, who received the positive results before the patient encounter but were not told how, or whether, to respond. Women in both the screened and unscreened groups had access to IPV resources, including psychologists, social workers, crisis hotlines, sexual assault crisis centers, counseling services, and women’s shelters, as well as physician visits. In addition, all participants completed a validated Composite Abuse Scale, a broader (30-question) self-administered measure of IPV, at the end of the visit. Those with positive scores were followed for 18 months.

At follow-up, women in both the screened and unscreened groups had accessed additional health care services. Both groups also had reduced IPV, posttraumatic stress disorder, depression, and alcohol problems, as well as improved quality of life and mental health. There was no statistical difference in outcomes between the groups.

Question 2: How effective are the screening techniques? The efficacy of at least five tools has been demonstrated. Fifteen diagnostic accuracy studies, using cross-sectional and prospective data, evaluated a total of 13 screening instruments.

Five of the 13 screening tools—the face-to-face Hurt, Insult, Threaten, and Scream (HITS) tool, the self-administered Ongoing Violence Assessment Tool (OVAT), the face-to-face Slapped, Threatened and Throw (STaT) instrument, the self-administered Humiliation, Afraid, Rape, Kick (HARK) tool, and the WAST—were at least 80% sensitive and 50% specific in identifying IPV in asymptomatic women.

Question 3: How well do the interventions reduce exposure to IPV, morbidity, or mortality in women with positive screens? Interventions improve outcomes, according to several studies.

One good-quality RCT comparing prenatal behavioral counseling by psychologists or social workers with usual care found that the intervention led to decreased IPV up to 10 weeks postpartum and improved birth outcomes. These included a reduction in preterm births, increased mean gestational age, and decreased rates of very low birth weight, although the difference for very low birth weight was not statistically significant.

One fair-quality trial comparing home visitation by paraprofessionals with usual care for postpartum women led to lower rates of IPV for those in the home visitation group three years after the intervention.

Another study compared a counseling intervention with usual care for women who had reported recent IPV. The intervention led to a decrease in pregnancy coercion—being physically or verbally threatened with pregnancy or prevented from using contraception—and an increase in the likelihood of ending an unsafe relationship.

Two trials evaluating counseling versus wallet-sized referral cards and nurse management versus usual care during pregnancy showed improved outcomes in both the intervention and control groups, with no statistically significant difference between them.

Question 4: What are the adverse effects of screening for IPV and interventions to reduce harm? There are few—if any—adverse effects, according to three RCTs and several descriptive studies. The RCTs found no adverse effects of screening or IPV interventions. Descriptive studies showed low levels of harm among a wide range of study populations and a variety of methods. However, some women experienced loss of privacy, emotional distress, and concerns about further abuse.

WHAT’S NEW
B recommendation finalized
Given the relative safety of screening, the potential benefits of interventions for women who have positive screens, and the availability of accurate screening instruments, the USPSTF disseminated a draft recommendation that health care providers screen all women between ages 14 and 46 for IPV. (The recommendation was finalized in late January 8).

CAVEATS
Universal screening questions remain
While the findings from this systematic review led the USPSTF to upgrade its recommendation for IPV screening from a rating of I (insufficient evidence) to a rating of B (moderate to substantial benefit of screening), additional high-quality studies are needed to definitively reveal the benefit of screening.

The validity of the large multicenter RCT that found no benefit from IPV screening was compromised by high dropout rates and, potentially, by the fact that women in the control group had access to materials that increased IPV awareness. Overall, the trials included in this review ranged from fair to good quality and had relatively high and differential rates of loss to follow-up, enrollment of dissimilar groups, and concern for the Hawthorne effect (in which participants change their behavior simply as a result of being involved in a study).

What’s more, some trials used narrowly defined populations, which could limit applicability. And, while some earlier studies had found higher rates of IPV disclosure using self-administered instruments compared with face-to-face questioning, more research is needed to identify the optimal screening method.⁹

CHALLENGES TO IMPLEMENTATION
The right screen—and reliable follow-up
Five of the screening instruments used in studies included in this systematic review accurately identified women with past or present IPV. Three of these are suitable for use in primary care:

•

HARK, a self-administered screen (available on the Internet at www.ncbi.nlm.nih.gov/pmc/articles/PMC2034562/table/T1)

• HITS, a face-to-face screen

•

WAST, a self-administered screen

More information about the latter two screens is available at www.cdc.gov/ncipc/pub-res/images/ipvandsvscreening.pdf.

After deciding which instrument to use, primary care clinicians still must determine how to incorporate screening into a busy practice.

Finally, clinicians should not screen for IPV until reliable procedures and resources for follow-up of patients who screen positive have been identified. Resources are readily available through local and national hotline numbers. The number of the National Domestic Violence Hotline is (800) 799-SAFE.       

REFERENCES
1. Nelson HD, Bougatsos C, Blazina I. Screening women for intimate partner violence: a systematic review to update the US Preventive Services Task Force recommendation. Ann Intern Med. 2012;156:796-808.

2.

National Center for Injury Prevention and Control. Costs of intimate partner violence against women in the United States. March 2003. www.cdc.gov/violenceprevention/pdf/IPVBook-a.pdf. Accessed November 7, 2012.

3. Coker AL, Davis KE, Arias I, et al. Physical and mental health effects of intimate partner violence for men and women. Am J Prev Med. 2002;23:260-268.

4. Committee on Preventive Services for Women, IOM. Clinical preventive services for women: closing the gaps. July 2011. www.iom.edu/Reports/2011/Clinical-Preventive-Services-for-Women-Closing-the-Gaps.aspx. Accessed November 7, 2012.

5. AMA, National Advisory Council on Violence and Abuse. Policy compendium. April 2008. www.ama-assn.org/ama1/pub/upload/mm/386/vio_policy_comp.pdf. Accessed November 7 2012.

6. American College of Obstetricians and Gynecologists. Screening tools—domestic violence. www.acog.org/About_ACOG/ACOG_Departments/Violence_Against_Women/Screening_Tools__Domestic_Violence. Accessed November 7 2012.

7. US Preventive Services Task Force. Screening for family and intimate partner violence. 2004. www.uspreventiveservicestaskforce.org/3rduspstf/famviolence/famviolrs.htm. Accessed November 7, 2012.

8. US Preventive Services Task Force. Screening for intimate partner violence and abuse of elderly and vulnerable adults. www.uspreventiveservicestaskforce.org/uspstf12/ipvelder/ipvelderfinalrs.htm. Accessed January 29, 2013.

9. Kapur NA, Windish DM. Optimal methods to screen men and women for intimate partner violence. J Interpers Violence. 2011;26:2335-2352.

Acknowledgement
The PURLs Surveillance System is supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2012. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice. 2013;62:90-92.

PRACTICE CHANGER
Use a validated tool to screen women of childbearing age for intimate partner violence (IPV) and follow up with any woman with a positive screen.¹

STRENGTH OF RECOMMENDATION
B: Based on a systematic review of 10 randomized controlled trials (RCTs), 11 prospective cohort and cross-sectional studies, and 13 diagnostic accuracy studies.

ILLUSTRATIVE CASE
A healthy 27-year-old woman schedules a visit to discuss birth control options. Should you screen her for IPV, and if so, what instrument should you use?

Each year in the United States, an estimated 5.3 million women ages 18 and older are affected by IPV, resulting in nearly 2 million injuries and more than $4 billion in direct medical and mental health costs.² In addition to the immediate effects, which include death as well as injuries from physical and sexual assault,² IPV has long-term consequences, such as chronic physical and mental illness and substance abuse.³

Too little evidence of benefit?
In 2011, the Institute of Medicine (IOM) recommended for the first time that all women of childbearing age be screened for IPV and identified IPV screening as one of a number of preventive services that are important to women’s health.⁴ The IOM’s recommendation is in line with positions held by the American Medical Association’s National Advisory Council on Violence and Abuse⁵ and the American College of Obstetrics and Gynecology.⁶ These recommendations differ from that of the US Preventive Services Task Force (USPSTF), which determined in 2004 that there was insufficient evidence for or against screening women for IPV.⁷ In issuing its I rating, the USPSTF cited a lack of studies evaluating the accuracy of screening tools for identifying IPV and a lack of evidence as to whether interventions lead to a reduction in harm.

The 2012 systematic review detailed below was undertaken on behalf of the USPSTF to assess the latest evidence and update its recommendation. The USPSTF and the Agency for Healthcare Research and Quality (AHRQ) determined the focus and scope of the review.

STUDY SUMMARY
USPSTF issues a B recommendation for IPV screening
Thirty-four studies of women who sought care in either primary care settings or emergency departments (EDs) but had no complaints related to IPV were included in the review, which addressed four key questions.

Question 1: Does screening women for current, past, or increased risk for IPV reduce exposure to IPV, morbidity, or mortality? No, according to one large RCT whose validity was compromised by high dropout rates. The researchers reviewed a multicenter RCT with 6,743 participants ages 18 to 64 to answer that question. (The study was deemed to be of fair quality because of the high percentage of dropouts from both the screened and unscreened groups.)

The women, recruited from primary care, acute care, and obstetrics and gynecology clinics in Canada, were randomly assigned to either screening with the Woman Abuse Screening Tool (WAST)—an eight-question, self-administered and validated tool—or no screening. Primary outcomes were exposure to abuse and quality of life in the 18 months after screening; secondary outcomes included both mental and physical ailments.

Those in the intervention group underwent screening before seeing their clinicians, who received the positive results before the patient encounter but were not told how, or whether, to respond. Women in both the screened and unscreened groups had access to IPV resources, including psychologists, social workers, crisis hotlines, sexual assault crisis centers, counseling services, and women’s shelters, as well as physician visits. In addition, all participants completed a validated Composite Abuse Scale, a broader (30-question) self-administered measure of IPV, at the end of the visit. Those with positive scores were followed for 18 months.

At follow-up, women in both the screened and unscreened groups had accessed additional health care services. Both groups also had reduced IPV, posttraumatic stress disorder, depression, and alcohol problems, as well as improved quality of life and mental health. There was no statistical difference in outcomes between the groups.

Question 2: How effective are the screening techniques? The efficacy of at least five tools has been demonstrated. Fifteen diagnostic accuracy studies, using cross-sectional and prospective data, evaluated a total of 13 screening instruments.

Five of the 13 screening tools—the face-to-face Hurt, Insult, Threaten, and Scream (HITS) tool, the self-administered Ongoing Violence Assessment Tool (OVAT), the face-to-face Slapped, Threatened and Throw (STaT) instrument, the self-administered Humiliation, Afraid, Rape, Kick (HARK) tool, and the WAST—were at least 80% sensitive and 50% specific in identifying IPV in asymptomatic women.

Question 3: How well do the interventions reduce exposure to IPV, morbidity, or mortality in women with positive screens? Interventions improve outcomes, according to several studies.

One good-quality RCT comparing prenatal behavioral counseling by psychologists or social workers with usual care found that the intervention led to decreased IPV up to 10 weeks postpartum and improved birth outcomes. These included a reduction in preterm births, increased mean gestational age, and decreased rates of very low birth weight, although the difference for very low birth weight was not statistically significant.

One fair-quality trial comparing home visitation by paraprofessionals with usual care for postpartum women led to lower rates of IPV for those in the home visitation group three years after the intervention.

Another study compared a counseling intervention with usual care for women who had reported recent IPV. The intervention led to a decrease in pregnancy coercion—being physically or verbally threatened with pregnancy or prevented from using contraception—and an increase in the likelihood of ending an unsafe relationship.

Two trials evaluating counseling versus wallet-sized referral cards and nurse management versus usual care during pregnancy showed improved outcomes in both the intervention and control groups, with no statistically significant difference between them.

Question 4: What are the adverse effects of screening for IPV and interventions to reduce harm? There are few—if any—adverse effects, according to three RCTs and several descriptive studies. The RCTs found no adverse effects of screening or IPV interventions. Descriptive studies showed low levels of harm among a wide range of study populations and a variety of methods. However, some women experienced loss of privacy, emotional distress, and concerns about further abuse.

WHAT’S NEW
B recommendation finalized
Given the relative safety of screening, the potential benefits of interventions for women who have positive screens, and the availability of accurate screening instruments, the USPSTF disseminated a draft recommendation that health care providers screen all women between ages 14 and 46 for IPV. (The recommendation was finalized in late January 8).

CAVEATS
Universal screening questions remain
While the findings from this systematic review led the USPSTF to upgrade its recommendation for IPV screening from a rating of I (insufficient evidence) to a rating of B (moderate to substantial benefit of screening), additional high-quality studies are needed to definitively reveal the benefit of screening.

The validity of the large multicenter RCT that found no benefit from IPV screening was compromised by high dropout rates and, potentially, by the fact that women in the control group had access to materials that increased IPV awareness. Overall, the trials included in this review ranged from fair to good quality and had relatively high and differential rates of loss to follow-up, enrollment of dissimilar groups, and concern for the Hawthorne effect (in which participants change their behavior simply as a result of being involved in a study).

What’s more, some trials used narrowly defined populations, which could limit applicability. And, while some earlier studies had found higher rates of IPV disclosure using self-administered instruments compared with face-to-face questioning, more research is needed to identify the optimal screening method.⁹

CHALLENGES TO IMPLEMENTATION
The right screen—and reliable follow-up
Five of the screening instruments used in studies included in this systematic review accurately identified women with past or present IPV. Three of these are suitable for use in primary care:

•

HARK, a self-administered screen (available on the Internet at www.ncbi.nlm.nih.gov/pmc/articles/PMC2034562/table/T1)

• HITS, a face-to-face screen

•

WAST, a self-administered screen

More information about the latter two screens is available at www.cdc.gov/ncipc/pub-res/images/ipvandsvscreening.pdf.

After deciding which instrument to use, primary care clinicians still must determine how to incorporate screening into a busy practice.

Finally, clinicians should not screen for IPV until reliable procedures and resources for follow-up of patients who screen positive have been identified. Resources are readily available through local and national hotline numbers. The number of the National Domestic Violence Hotline is (800) 799-SAFE.       

REFERENCES
1. Nelson HD, Bougatsos C, Blazina I. Screening women for intimate partner violence: a systematic review to update the US Preventive Services Task Force recommendation. Ann Intern Med. 2012;156:796-808.

2.

National Center for Injury Prevention and Control. Costs of intimate partner violence against women in the United States. March 2003. www.cdc.gov/violenceprevention/pdf/IPVBook-a.pdf. Accessed November 7, 2012.

3. Coker AL, Davis KE, Arias I, et al. Physical and mental health effects of intimate partner violence for men and women. Am J Prev Med. 2002;23:260-268.

4. Committee on Preventive Services for Women, IOM. Clinical preventive services for women: closing the gaps. July 2011. www.iom.edu/Reports/2011/Clinical-Preventive-Services-for-Women-Closing-the-Gaps.aspx. Accessed November 7, 2012.

5. AMA, National Advisory Council on Violence and Abuse. Policy compendium. April 2008. www.ama-assn.org/ama1/pub/upload/mm/386/vio_policy_comp.pdf. Accessed November 7 2012.

6. American College of Obstetricians and Gynecologists. Screening tools—domestic violence. www.acog.org/About_ACOG/ACOG_Departments/Violence_Against_Women/Screening_Tools__Domestic_Violence. Accessed November 7 2012.

7. US Preventive Services Task Force. Screening for family and intimate partner violence. 2004. www.uspreventiveservicestaskforce.org/3rduspstf/famviolence/famviolrs.htm. Accessed November 7, 2012.

8. US Preventive Services Task Force. Screening for intimate partner violence and abuse of elderly and vulnerable adults. www.uspreventiveservicestaskforce.org/uspstf12/ipvelder/ipvelderfinalrs.htm. Accessed January 29, 2013.

9. Kapur NA, Windish DM. Optimal methods to screen men and women for intimate partner violence. J Interpers Violence. 2011;26:2335-2352.

Acknowledgement
The PURLs Surveillance System is supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2012. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice. 2013;62:90-92.

PRACTICE CHANGER
Use a validated tool to screen women of childbearing age for intimate partner violence (IPV) and follow up with any woman with a positive screen.¹

STRENGTH OF RECOMMENDATION
B: Based on a systematic review of 10 randomized controlled trials (RCTs), 11 prospective cohort and cross-sectional studies, and 13 diagnostic accuracy studies.

ILLUSTRATIVE CASE
A healthy 27-year-old woman schedules a visit to discuss birth control options. Should you screen her for IPV, and if so, what instrument should you use?

Each year in the United States, an estimated 5.3 million women ages 18 and older are affected by IPV, resulting in nearly 2 million injuries and more than $4 billion in direct medical and mental health costs.² In addition to the immediate effects, which include death as well as injuries from physical and sexual assault,² IPV has long-term consequences, such as chronic physical and mental illness and substance abuse.³

Too little evidence of benefit?
In 2011, the Institute of Medicine (IOM) recommended for the first time that all women of childbearing age be screened for IPV and identified IPV screening as one of a number of preventive services that are important to women’s health.⁴ The IOM’s recommendation is in line with positions held by the American Medical Association’s National Advisory Council on Violence and Abuse⁵ and the American College of Obstetrics and Gynecology.⁶ These recommendations differ from that of the US Preventive Services Task Force (USPSTF), which determined in 2004 that there was insufficient evidence for or against screening women for IPV.⁷ In issuing its I rating, the USPSTF cited a lack of studies evaluating the accuracy of screening tools for identifying IPV and a lack of evidence as to whether interventions lead to a reduction in harm.

The 2012 systematic review detailed below was undertaken on behalf of the USPSTF to assess the latest evidence and update its recommendation. The USPSTF and the Agency for Healthcare Research and Quality (AHRQ) determined the focus and scope of the review.

STUDY SUMMARY
USPSTF issues a B recommendation for IPV screening
Thirty-four studies of women who sought care in either primary care settings or emergency departments (EDs) but had no complaints related to IPV were included in the review, which addressed four key questions.

Question 1: Does screening women for current, past, or increased risk for IPV reduce exposure to IPV, morbidity, or mortality? No, according to one large RCT whose validity was compromised by high dropout rates. The researchers reviewed a multicenter RCT with 6,743 participants ages 18 to 64 to answer that question. (The study was deemed to be of fair quality because of the high percentage of dropouts from both the screened and unscreened groups.)

The women, recruited from primary care, acute care, and obstetrics and gynecology clinics in Canada, were randomly assigned to either screening with the Woman Abuse Screening Tool (WAST)—an eight-question, self-administered and validated tool—or no screening. Primary outcomes were exposure to abuse and quality of life in the 18 months after screening; secondary outcomes included both mental and physical ailments.

Those in the intervention group underwent screening before seeing their clinicians, who received the positive results before the patient encounter but were not told how, or whether, to respond. Women in both the screened and unscreened groups had access to IPV resources, including psychologists, social workers, crisis hotlines, sexual assault crisis centers, counseling services, and women’s shelters, as well as physician visits. In addition, all participants completed a validated Composite Abuse Scale, a broader (30-question) self-administered measure of IPV, at the end of the visit. Those with positive scores were followed for 18 months.

At follow-up, women in both the screened and unscreened groups had accessed additional health care services. Both groups also had reduced IPV, posttraumatic stress disorder, depression, and alcohol problems, as well as improved quality of life and mental health. There was no statistical difference in outcomes between the groups.

Question 2: How effective are the screening techniques? The efficacy of at least five tools has been demonstrated. Fifteen diagnostic accuracy studies, using cross-sectional and prospective data, evaluated a total of 13 screening instruments.

Five of the 13 screening tools—the face-to-face Hurt, Insult, Threaten, and Scream (HITS) tool, the self-administered Ongoing Violence Assessment Tool (OVAT), the face-to-face Slapped, Threatened and Throw (STaT) instrument, the self-administered Humiliation, Afraid, Rape, Kick (HARK) tool, and the WAST—were at least 80% sensitive and 50% specific in identifying IPV in asymptomatic women.

Question 3: How well do the interventions reduce exposure to IPV, morbidity, or mortality in women with positive screens? Interventions improve outcomes, according to several studies.

One good-quality RCT comparing prenatal behavioral counseling by psychologists or social workers with usual care found that the intervention led to decreased IPV up to 10 weeks postpartum and improved birth outcomes. These included a reduction in preterm births, increased mean gestational age, and decreased rates of very low birth weight, although the difference for very low birth weight was not statistically significant.

One fair-quality trial comparing home visitation by paraprofessionals with usual care for postpartum women led to lower rates of IPV for those in the home visitation group three years after the intervention.

Another study compared a counseling intervention with usual care for women who had reported recent IPV. The intervention led to a decrease in pregnancy coercion—being physically or verbally threatened with pregnancy or prevented from using contraception—and an increase in the likelihood of ending an unsafe relationship.

Two trials evaluating counseling versus wallet-sized referral cards and nurse management versus usual care during pregnancy showed improved outcomes in both the intervention and control groups, with no statistically significant difference between them.

Question 4: What are the adverse effects of screening for IPV and interventions to reduce harm? There are few—if any—adverse effects, according to three RCTs and several descriptive studies. The RCTs found no adverse effects of screening or IPV interventions. Descriptive studies showed low levels of harm among a wide range of study populations and a variety of methods. However, some women experienced loss of privacy, emotional distress, and concerns about further abuse.

WHAT’S NEW
B recommendation finalized
Given the relative safety of screening, the potential benefits of interventions for women who have positive screens, and the availability of accurate screening instruments, the USPSTF disseminated a draft recommendation that health care providers screen all women between ages 14 and 46 for IPV. (The recommendation was finalized in late January 8).

CAVEATS
Universal screening questions remain
While the findings from this systematic review led the USPSTF to upgrade its recommendation for IPV screening from a rating of I (insufficient evidence) to a rating of B (moderate to substantial benefit of screening), additional high-quality studies are needed to definitively reveal the benefit of screening.

The validity of the large multicenter RCT that found no benefit from IPV screening was compromised by high dropout rates and, potentially, by the fact that women in the control group had access to materials that increased IPV awareness. Overall, the trials included in this review ranged from fair to good quality and had relatively high and differential rates of loss to follow-up, enrollment of dissimilar groups, and concern for the Hawthorne effect (in which participants change their behavior simply as a result of being involved in a study).

What’s more, some trials used narrowly defined populations, which could limit applicability. And, while some earlier studies had found higher rates of IPV disclosure using self-administered instruments compared with face-to-face questioning, more research is needed to identify the optimal screening method.⁹

CHALLENGES TO IMPLEMENTATION
The right screen—and reliable follow-up
Five of the screening instruments used in studies included in this systematic review accurately identified women with past or present IPV. Three of these are suitable for use in primary care:

•

HARK, a self-administered screen (available on the Internet at www.ncbi.nlm.nih.gov/pmc/articles/PMC2034562/table/T1)

• HITS, a face-to-face screen

•

WAST, a self-administered screen

More information about the latter two screens is available at www.cdc.gov/ncipc/pub-res/images/ipvandsvscreening.pdf.

After deciding which instrument to use, primary care clinicians still must determine how to incorporate screening into a busy practice.

Finally, clinicians should not screen for IPV until reliable procedures and resources for follow-up of patients who screen positive have been identified. Resources are readily available through local and national hotline numbers. The number of the National Domestic Violence Hotline is (800) 799-SAFE.       

REFERENCES
1. Nelson HD, Bougatsos C, Blazina I. Screening women for intimate partner violence: a systematic review to update the US Preventive Services Task Force recommendation. Ann Intern Med. 2012;156:796-808.

2.

National Center for Injury Prevention and Control. Costs of intimate partner violence against women in the United States. March 2003. www.cdc.gov/violenceprevention/pdf/IPVBook-a.pdf. Accessed November 7, 2012.

3. Coker AL, Davis KE, Arias I, et al. Physical and mental health effects of intimate partner violence for men and women. Am J Prev Med. 2002;23:260-268.

4. Committee on Preventive Services for Women, IOM. Clinical preventive services for women: closing the gaps. July 2011. www.iom.edu/Reports/2011/Clinical-Preventive-Services-for-Women-Closing-the-Gaps.aspx. Accessed November 7, 2012.

5. AMA, National Advisory Council on Violence and Abuse. Policy compendium. April 2008. www.ama-assn.org/ama1/pub/upload/mm/386/vio_policy_comp.pdf. Accessed November 7 2012.

6. American College of Obstetricians and Gynecologists. Screening tools—domestic violence. www.acog.org/About_ACOG/ACOG_Departments/Violence_Against_Women/Screening_Tools__Domestic_Violence. Accessed November 7 2012.

7. US Preventive Services Task Force. Screening for family and intimate partner violence. 2004. www.uspreventiveservicestaskforce.org/3rduspstf/famviolence/famviolrs.htm. Accessed November 7, 2012.

8. US Preventive Services Task Force. Screening for intimate partner violence and abuse of elderly and vulnerable adults. www.uspreventiveservicestaskforce.org/uspstf12/ipvelder/ipvelderfinalrs.htm. Accessed January 29, 2013.

9. Kapur NA, Windish DM. Optimal methods to screen men and women for intimate partner violence. J Interpers Violence. 2011;26:2335-2352.

Acknowledgement
The PURLs Surveillance System is supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2012. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice. 2013;62:90-92.

ILLUSTRATIVE CASE

A healthy 27-year-old woman schedules a visit to discuss birth control options. Should you screen her for IPV and if so, what instrument should you use?

Each year in the United States, an estimated 5.3 million women ages 18 and older are affected by IPV, resulting in nearly 2 million injuries and more than $4 billion in direct medical and mental health costs.² In addition to the immediate effects, which include death as well as injuries from physical and sexual assault,² IPV has long-term consequences, such as chronic physical and mental illness and substance abuse.³

Too little evidence of benefit?
In 2011, the Institute of Medicine (IOM) recommended for the first time that all women of childbearing age be screened for IPV-and identified IPV screening as one of a number of preventive services that are important to women’s health.⁴ The IOM’s recommendation is in line with positions held by the American Medical Association’s National Advisory Council on Violence and Abuse⁵ and the American College of Obstetrics and Gynecology.⁶ These recommendations differ from that of the US Preventive Services Task Force (USPSTF), which determined in 2004 that there was insufficient evidence for or against screening women for IPV.⁷ In issuing its “I” rating, the USPSTF cited a lack of studies evaluating the accuracy of screening tools for identifying IPV and a lack of evidence as to whether interventions lead to a reduction in harm.

The 2012 systemic review detailed below was undertaken on behalf of the USPSTF to assess the latest evidence and update its recommendation. The USPSTF and Agency for Healthcare Research and Quality (AHRQ) determined the focus and scope of the review.

STUDY SUMMARY: USPSTF issues a B recommendation for IPV screening

Thirty-four studies of women who sought care in either primary care settings or emergency departments (EDs) but had no complaints related to IPV were included in the review, which addressed 4 key questions.

Question 1: Does screening women for current, past, or increased risk of IPV reduce exposure to IPV, morbidity, or mortality?

No, according to one large RCT whose validity was compromised by high dropout rates. The researchers reviewed a multicenter RCT with 6743 participants ages 18 to 64 years to answer that question. (The study was deemed to be of fair quality because of the high percentage of dropouts from both the screened and unscreened groups.)

The women, recruited from primary care, acute care, and obstetrics and gynecology clinics in Canada, were randomly assigned to either screening with the Woman Abuse Screening Tool (WAST)—an 8-question, self-administered and validated tool—or no screening. Primary outcomes were exposure to abuse and quality of life in the 18 months after screening; secondary outcomes included both mental and physical ailments.

Those in the intervention group underwent screening before seeing their clinicians, who received the positive results before the patient encounter but were not told how, or whether, to respond. Women in both the screened and unscreened groups had access to IPV resources, including psychologists, social workers, crisis hotlines, sexual assault crisis centers, counseling services, and women’s shelters, as well as physician visits. In addition, all participants completed a validated Composite Abuse Scale, a broader (30-question) self-administered measure of IPV, at the end of the visit. Those with positive scores were followed for 18 months.

At follow-up, women in both the screened and unscreened groups had accessed additional health care services. Both groups also had reduced IPV, posttraumatic stress disorder, depression, and alcohol problems, and improved quality of life and mental health. There was no statistical difference in outcomes between the groups.

Question 2: How effective are the screening techniques?

The efficacy of at least 5 tools has been demonstrated. Fifteen diagnostic accuracy studies, using cross-sectional and prospective data, evaluated a total of 13 screening instruments.

Five of the 13 screening tools—the face-to-face Hurt, Insult, Threaten, and Scream (HITS) tool, the self-administered Ongoing Violence Assessment Tool (OVAT), the face-to-face Slapped, Threatened and Throw (STaT) instrument, the self-administered Humiliation, Afraid, Rape, Kick (HARK) tool, and the WAST—were at least 80% sensitive and 50% specific in identifying IPV in asymptomatic women.

Question 3: How well do the interventions reduce exposure to IPV, morbidity, or mortality in women with positive screens?

Interventions improve outcomes, according to several studies. One good-quality RCT comparing prenatal behavioral counseling by psychologists or social workers with usual care found that the intervention led to decreased IPV up to 10 weeks’ postpartum and improved birth outcomes. These included a reduction in preterm births, increased mean gestational age, and decreased rates of very low birth weight, although the difference for very low birth weight was not statistically significant.

One fair-quality trial comparing home visitation by paraprofessionals with usual care for postpartum women led to lower rates of IPV for those in the home visitation group 3 years after the intervention.

Another study compared a counseling intervention with usual care for women who had reported recent IPV. The intervention led to a decrease in pregnancy coercion—being physically or verbally threatened with pregnancy or prevented from using contraception—and an increase in the likelihood of ending an unsafe relationship.

Two trials evaluating counseling vs wallet-sized referral cards and nurse management vs usual care during pregnancy showed improved outcomes in both the intervention and control groups, with no statistically significant difference between them.

Question 4: What are the adverse effects of screening for IPV and interventions to reduce harm?

There are few—if any—adverse effects, according to 3 RCTs and several descriptive studies. The RCTs found no adverse effects of screening or IPV interventions. Descriptive studies showed low levels of harm among a wide range of study populations and a variety of methods. However, some women experienced loss of privacy, emotional distress, and concerns about further abuse.

WHAT’S NEW: B recommendation is finalized

Given the relative safety of screening, the potential benefits of interventions for women who have positive screens, and the availability of accurate screening instruments, the USPSTF disseminated a draft recommendation that health care providers screen all women between 14 and 46 years old for IPV.At presstime in late January, the recommendation was finalized.⁸

CAVEATS: Universal screening questions remain

While the findings from this systematic review led the USPSTF to upgrade its recommendation for IPV screening from an I (insufficient evidence) to a B (moderate to substantial benefit of screening), additional high-quality studies are needed to definitively reveal the benefit of screening.

The validity of the large multicenter RCT that found no benefit from IPV screening was compromised by high dropout rates and, potentially, by the fact that women in the control group had access to materials that increased IPV awareness. Overall, the trials included in this systematic review ranged from fair to good quality and had relatively high and differential rates of loss to follow-up, enrollment of dissimilar groups, and concern for the Hawthorne effect (in which participants change their behavior simply as a result of being involved in a study).

What’s more, some trials used narrowly defined populations, which could limit applicability. And, while some earlier studies had found higher rates of IPV disclosure using self-administered instruments compared with face-to-face questioning, more research is needed to identify the optimal screening method.⁹

CHALLENGES TO IMPLEMENTATION: The right screen—and reliable follow-up

Five of the screening instruments used in studies included in this systematic review accurately identified women with past or present IPV. Three of these are suitable for use in primary care:

• HARK, a self-administered screen available at www.ncbi.nlm.nih.gov/pmc/articles/PMC2034562/table/T1
• HITS, a face-to-face screen
• WAST, a self-administered screen (more information about these screens is available at http://www.cdc.gov/ncipc/pub-res/images/ipvandsvscreening.pdf).

After deciding which instrument to use, family physicians still must determine how to incorporate screening into a busy practice.

Finally, physicians should not screen for IPV until reliable procedures and resources for follow-up of patients who screen positive have been identified. Resources are readily available through local and national hotline numbers. The number of the National Domestic Violence Hotline is 800-799-SAFE.

Acknowledgement

The PURLs Surveillance System is supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A healthy 27-year-old woman schedules a visit to discuss birth control options. Should you screen her for IPV and if so, what instrument should you use?

Each year in the United States, an estimated 5.3 million women ages 18 and older are affected by IPV, resulting in nearly 2 million injuries and more than $4 billion in direct medical and mental health costs.² In addition to the immediate effects, which include death as well as injuries from physical and sexual assault,² IPV has long-term consequences, such as chronic physical and mental illness and substance abuse.³

Too little evidence of benefit?
In 2011, the Institute of Medicine (IOM) recommended for the first time that all women of childbearing age be screened for IPV-and identified IPV screening as one of a number of preventive services that are important to women’s health.⁴ The IOM’s recommendation is in line with positions held by the American Medical Association’s National Advisory Council on Violence and Abuse⁵ and the American College of Obstetrics and Gynecology.⁶ These recommendations differ from that of the US Preventive Services Task Force (USPSTF), which determined in 2004 that there was insufficient evidence for or against screening women for IPV.⁷ In issuing its “I” rating, the USPSTF cited a lack of studies evaluating the accuracy of screening tools for identifying IPV and a lack of evidence as to whether interventions lead to a reduction in harm.

The 2012 systemic review detailed below was undertaken on behalf of the USPSTF to assess the latest evidence and update its recommendation. The USPSTF and Agency for Healthcare Research and Quality (AHRQ) determined the focus and scope of the review.

STUDY SUMMARY: USPSTF issues a B recommendation for IPV screening

Thirty-four studies of women who sought care in either primary care settings or emergency departments (EDs) but had no complaints related to IPV were included in the review, which addressed 4 key questions.

Question 1: Does screening women for current, past, or increased risk of IPV reduce exposure to IPV, morbidity, or mortality?

No, according to one large RCT whose validity was compromised by high dropout rates. The researchers reviewed a multicenter RCT with 6743 participants ages 18 to 64 years to answer that question. (The study was deemed to be of fair quality because of the high percentage of dropouts from both the screened and unscreened groups.)

The women, recruited from primary care, acute care, and obstetrics and gynecology clinics in Canada, were randomly assigned to either screening with the Woman Abuse Screening Tool (WAST)—an 8-question, self-administered and validated tool—or no screening. Primary outcomes were exposure to abuse and quality of life in the 18 months after screening; secondary outcomes included both mental and physical ailments.

Those in the intervention group underwent screening before seeing their clinicians, who received the positive results before the patient encounter but were not told how, or whether, to respond. Women in both the screened and unscreened groups had access to IPV resources, including psychologists, social workers, crisis hotlines, sexual assault crisis centers, counseling services, and women’s shelters, as well as physician visits. In addition, all participants completed a validated Composite Abuse Scale, a broader (30-question) self-administered measure of IPV, at the end of the visit. Those with positive scores were followed for 18 months.

At follow-up, women in both the screened and unscreened groups had accessed additional health care services. Both groups also had reduced IPV, posttraumatic stress disorder, depression, and alcohol problems, and improved quality of life and mental health. There was no statistical difference in outcomes between the groups.

Question 2: How effective are the screening techniques?

The efficacy of at least 5 tools has been demonstrated. Fifteen diagnostic accuracy studies, using cross-sectional and prospective data, evaluated a total of 13 screening instruments.

Five of the 13 screening tools—the face-to-face Hurt, Insult, Threaten, and Scream (HITS) tool, the self-administered Ongoing Violence Assessment Tool (OVAT), the face-to-face Slapped, Threatened and Throw (STaT) instrument, the self-administered Humiliation, Afraid, Rape, Kick (HARK) tool, and the WAST—were at least 80% sensitive and 50% specific in identifying IPV in asymptomatic women.

Question 3: How well do the interventions reduce exposure to IPV, morbidity, or mortality in women with positive screens?

Interventions improve outcomes, according to several studies. One good-quality RCT comparing prenatal behavioral counseling by psychologists or social workers with usual care found that the intervention led to decreased IPV up to 10 weeks’ postpartum and improved birth outcomes. These included a reduction in preterm births, increased mean gestational age, and decreased rates of very low birth weight, although the difference for very low birth weight was not statistically significant.

One fair-quality trial comparing home visitation by paraprofessionals with usual care for postpartum women led to lower rates of IPV for those in the home visitation group 3 years after the intervention.

Another study compared a counseling intervention with usual care for women who had reported recent IPV. The intervention led to a decrease in pregnancy coercion—being physically or verbally threatened with pregnancy or prevented from using contraception—and an increase in the likelihood of ending an unsafe relationship.

Two trials evaluating counseling vs wallet-sized referral cards and nurse management vs usual care during pregnancy showed improved outcomes in both the intervention and control groups, with no statistically significant difference between them.

Question 4: What are the adverse effects of screening for IPV and interventions to reduce harm?

There are few—if any—adverse effects, according to 3 RCTs and several descriptive studies. The RCTs found no adverse effects of screening or IPV interventions. Descriptive studies showed low levels of harm among a wide range of study populations and a variety of methods. However, some women experienced loss of privacy, emotional distress, and concerns about further abuse.

WHAT’S NEW: B recommendation is finalized

Given the relative safety of screening, the potential benefits of interventions for women who have positive screens, and the availability of accurate screening instruments, the USPSTF disseminated a draft recommendation that health care providers screen all women between 14 and 46 years old for IPV.At presstime in late January, the recommendation was finalized.⁸

CAVEATS: Universal screening questions remain

While the findings from this systematic review led the USPSTF to upgrade its recommendation for IPV screening from an I (insufficient evidence) to a B (moderate to substantial benefit of screening), additional high-quality studies are needed to definitively reveal the benefit of screening.

The validity of the large multicenter RCT that found no benefit from IPV screening was compromised by high dropout rates and, potentially, by the fact that women in the control group had access to materials that increased IPV awareness. Overall, the trials included in this systematic review ranged from fair to good quality and had relatively high and differential rates of loss to follow-up, enrollment of dissimilar groups, and concern for the Hawthorne effect (in which participants change their behavior simply as a result of being involved in a study).

What’s more, some trials used narrowly defined populations, which could limit applicability. And, while some earlier studies had found higher rates of IPV disclosure using self-administered instruments compared with face-to-face questioning, more research is needed to identify the optimal screening method.⁹

CHALLENGES TO IMPLEMENTATION: The right screen—and reliable follow-up

Five of the screening instruments used in studies included in this systematic review accurately identified women with past or present IPV. Three of these are suitable for use in primary care:

• HARK, a self-administered screen available at www.ncbi.nlm.nih.gov/pmc/articles/PMC2034562/table/T1
• HITS, a face-to-face screen
• WAST, a self-administered screen (more information about these screens is available at http://www.cdc.gov/ncipc/pub-res/images/ipvandsvscreening.pdf).

After deciding which instrument to use, family physicians still must determine how to incorporate screening into a busy practice.

Finally, physicians should not screen for IPV until reliable procedures and resources for follow-up of patients who screen positive have been identified. Resources are readily available through local and national hotline numbers. The number of the National Domestic Violence Hotline is 800-799-SAFE.

Acknowledgement

The PURLs Surveillance System is supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A healthy 27-year-old woman schedules a visit to discuss birth control options. Should you screen her for IPV and if so, what instrument should you use?

Each year in the United States, an estimated 5.3 million women ages 18 and older are affected by IPV, resulting in nearly 2 million injuries and more than $4 billion in direct medical and mental health costs.² In addition to the immediate effects, which include death as well as injuries from physical and sexual assault,² IPV has long-term consequences, such as chronic physical and mental illness and substance abuse.³

Too little evidence of benefit?
In 2011, the Institute of Medicine (IOM) recommended for the first time that all women of childbearing age be screened for IPV-and identified IPV screening as one of a number of preventive services that are important to women’s health.⁴ The IOM’s recommendation is in line with positions held by the American Medical Association’s National Advisory Council on Violence and Abuse⁵ and the American College of Obstetrics and Gynecology.⁶ These recommendations differ from that of the US Preventive Services Task Force (USPSTF), which determined in 2004 that there was insufficient evidence for or against screening women for IPV.⁷ In issuing its “I” rating, the USPSTF cited a lack of studies evaluating the accuracy of screening tools for identifying IPV and a lack of evidence as to whether interventions lead to a reduction in harm.

The 2012 systemic review detailed below was undertaken on behalf of the USPSTF to assess the latest evidence and update its recommendation. The USPSTF and Agency for Healthcare Research and Quality (AHRQ) determined the focus and scope of the review.

STUDY SUMMARY: USPSTF issues a B recommendation for IPV screening

Thirty-four studies of women who sought care in either primary care settings or emergency departments (EDs) but had no complaints related to IPV were included in the review, which addressed 4 key questions.

Question 1: Does screening women for current, past, or increased risk of IPV reduce exposure to IPV, morbidity, or mortality?

No, according to one large RCT whose validity was compromised by high dropout rates. The researchers reviewed a multicenter RCT with 6743 participants ages 18 to 64 years to answer that question. (The study was deemed to be of fair quality because of the high percentage of dropouts from both the screened and unscreened groups.)

The women, recruited from primary care, acute care, and obstetrics and gynecology clinics in Canada, were randomly assigned to either screening with the Woman Abuse Screening Tool (WAST)—an 8-question, self-administered and validated tool—or no screening. Primary outcomes were exposure to abuse and quality of life in the 18 months after screening; secondary outcomes included both mental and physical ailments.

Those in the intervention group underwent screening before seeing their clinicians, who received the positive results before the patient encounter but were not told how, or whether, to respond. Women in both the screened and unscreened groups had access to IPV resources, including psychologists, social workers, crisis hotlines, sexual assault crisis centers, counseling services, and women’s shelters, as well as physician visits. In addition, all participants completed a validated Composite Abuse Scale, a broader (30-question) self-administered measure of IPV, at the end of the visit. Those with positive scores were followed for 18 months.

At follow-up, women in both the screened and unscreened groups had accessed additional health care services. Both groups also had reduced IPV, posttraumatic stress disorder, depression, and alcohol problems, and improved quality of life and mental health. There was no statistical difference in outcomes between the groups.

Question 2: How effective are the screening techniques?

The efficacy of at least 5 tools has been demonstrated. Fifteen diagnostic accuracy studies, using cross-sectional and prospective data, evaluated a total of 13 screening instruments.

Five of the 13 screening tools—the face-to-face Hurt, Insult, Threaten, and Scream (HITS) tool, the self-administered Ongoing Violence Assessment Tool (OVAT), the face-to-face Slapped, Threatened and Throw (STaT) instrument, the self-administered Humiliation, Afraid, Rape, Kick (HARK) tool, and the WAST—were at least 80% sensitive and 50% specific in identifying IPV in asymptomatic women.

Question 3: How well do the interventions reduce exposure to IPV, morbidity, or mortality in women with positive screens?

Interventions improve outcomes, according to several studies. One good-quality RCT comparing prenatal behavioral counseling by psychologists or social workers with usual care found that the intervention led to decreased IPV up to 10 weeks’ postpartum and improved birth outcomes. These included a reduction in preterm births, increased mean gestational age, and decreased rates of very low birth weight, although the difference for very low birth weight was not statistically significant.

One fair-quality trial comparing home visitation by paraprofessionals with usual care for postpartum women led to lower rates of IPV for those in the home visitation group 3 years after the intervention.

Another study compared a counseling intervention with usual care for women who had reported recent IPV. The intervention led to a decrease in pregnancy coercion—being physically or verbally threatened with pregnancy or prevented from using contraception—and an increase in the likelihood of ending an unsafe relationship.

Two trials evaluating counseling vs wallet-sized referral cards and nurse management vs usual care during pregnancy showed improved outcomes in both the intervention and control groups, with no statistically significant difference between them.

Question 4: What are the adverse effects of screening for IPV and interventions to reduce harm?

There are few—if any—adverse effects, according to 3 RCTs and several descriptive studies. The RCTs found no adverse effects of screening or IPV interventions. Descriptive studies showed low levels of harm among a wide range of study populations and a variety of methods. However, some women experienced loss of privacy, emotional distress, and concerns about further abuse.

WHAT’S NEW: B recommendation is finalized

Given the relative safety of screening, the potential benefits of interventions for women who have positive screens, and the availability of accurate screening instruments, the USPSTF disseminated a draft recommendation that health care providers screen all women between 14 and 46 years old for IPV.At presstime in late January, the recommendation was finalized.⁸

CAVEATS: Universal screening questions remain

While the findings from this systematic review led the USPSTF to upgrade its recommendation for IPV screening from an I (insufficient evidence) to a B (moderate to substantial benefit of screening), additional high-quality studies are needed to definitively reveal the benefit of screening.

The validity of the large multicenter RCT that found no benefit from IPV screening was compromised by high dropout rates and, potentially, by the fact that women in the control group had access to materials that increased IPV awareness. Overall, the trials included in this systematic review ranged from fair to good quality and had relatively high and differential rates of loss to follow-up, enrollment of dissimilar groups, and concern for the Hawthorne effect (in which participants change their behavior simply as a result of being involved in a study).

What’s more, some trials used narrowly defined populations, which could limit applicability. And, while some earlier studies had found higher rates of IPV disclosure using self-administered instruments compared with face-to-face questioning, more research is needed to identify the optimal screening method.⁹

CHALLENGES TO IMPLEMENTATION: The right screen—and reliable follow-up

Five of the screening instruments used in studies included in this systematic review accurately identified women with past or present IPV. Three of these are suitable for use in primary care:

• HARK, a self-administered screen available at www.ncbi.nlm.nih.gov/pmc/articles/PMC2034562/table/T1
• HITS, a face-to-face screen
• WAST, a self-administered screen (more information about these screens is available at http://www.cdc.gov/ncipc/pub-res/images/ipvandsvscreening.pdf).

After deciding which instrument to use, family physicians still must determine how to incorporate screening into a busy practice.

Finally, physicians should not screen for IPV until reliable procedures and resources for follow-up of patients who screen positive have been identified. Resources are readily available through local and national hotline numbers. The number of the National Domestic Violence Hotline is 800-799-SAFE.

Acknowledgement

The PURLs Surveillance System is supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.