HIV budding from a cultured

lymphocyte; Credit: CDC

Cancer patients infected with HIV are less likely than their uninfected peers to receive cancer treatment, according to research published in the Journal of Clinical Oncology.

Results showed that HIV-positive patients were roughly twice as likely to go untreated for lymphomas and other cancers.

The researchers believe a lack of clinical trial data and treatment guidelines for HIV patients with cancer may contribute to this health disparity.

To assess the role of HIV status on cancer treatment, Gita Suneja, MD, of the University of Pennsylvania in Philadelphia, and her colleagues used data from the National Cancer Institute’s HIV/AIDS Cancer Match Study.

This included 3045 HIV-infected patients and 1,087,648 uninfected patients. The patients had been diagnosed with Hodgkin lymphoma, diffuse large B-cell lymphoma, or cervical, lung, anal, prostate, colorectal, or breast cancer from 1996 through 2010.

For each cancer type, the researchers assessed the relationship between HIV status and cancer treatment, adjusted for cancer stage, sex, age at cancer diagnosis, race/ethnicity, year of cancer diagnosis, and US state.

For all but 1 cancer type, there was a significantly higher proportion of HIV-infected patients who did not receive cancer treatment when compared with uninfected patients.

The adjusted odds ratios (aORs) were 1.67 for diffuse large B-cell lymphoma, 1.77 for Hodgkin lymphoma, 1.60 for cervical cancer, 1.79 for prostate cancer, 1.81 for breast cancer, 2.18 for lung cancer, and 2.27 for colorectal cancer.

Anal cancer was the only malignancy for which HIV status did not appear to impact treatment. The aOR was 1.01.

Among HIV-infected individuals, factors independently associated with a lack of cancer treatment included low CD4 count, male sex with injection drug use as mode of HIV exposure, age 45 to 64 years, black race, and distant or unknown cancer stage.

“In my clinical experience, I have seen uncertainty surrounding treatment of HIV-infected cancer patients,” Dr Suneja said. “Patients with HIV have typically been excluded from clinical trials, and, therefore, oncologists do not know if the best available treatments are equally safe and effective in those with HIV.”

“Many oncologists rely on guidelines based on such trials for treatment decision-making, and, in the absence of guidance, they may elect not to treat HIV-infected cancer patients due to concerns about adverse side effects or poor survival. This could help explain, in part, why many HIV-positive cancer patients are not receiving appropriate cancer care.”

Therefore, Dr Suneja and her colleagues recommend that cancer trials begin enrolling HIV-infected patients and cancer management guidelines incorporate recommendations for HIV-infected patients.

HIV budding from a cultured

lymphocyte; Credit: CDC

Cancer patients infected with HIV are less likely than their uninfected peers to receive cancer treatment, according to research published in the Journal of Clinical Oncology.

Results showed that HIV-positive patients were roughly twice as likely to go untreated for lymphomas and other cancers.

The researchers believe a lack of clinical trial data and treatment guidelines for HIV patients with cancer may contribute to this health disparity.

To assess the role of HIV status on cancer treatment, Gita Suneja, MD, of the University of Pennsylvania in Philadelphia, and her colleagues used data from the National Cancer Institute’s HIV/AIDS Cancer Match Study.

This included 3045 HIV-infected patients and 1,087,648 uninfected patients. The patients had been diagnosed with Hodgkin lymphoma, diffuse large B-cell lymphoma, or cervical, lung, anal, prostate, colorectal, or breast cancer from 1996 through 2010.

For each cancer type, the researchers assessed the relationship between HIV status and cancer treatment, adjusted for cancer stage, sex, age at cancer diagnosis, race/ethnicity, year of cancer diagnosis, and US state.

For all but 1 cancer type, there was a significantly higher proportion of HIV-infected patients who did not receive cancer treatment when compared with uninfected patients.

The adjusted odds ratios (aORs) were 1.67 for diffuse large B-cell lymphoma, 1.77 for Hodgkin lymphoma, 1.60 for cervical cancer, 1.79 for prostate cancer, 1.81 for breast cancer, 2.18 for lung cancer, and 2.27 for colorectal cancer.

Anal cancer was the only malignancy for which HIV status did not appear to impact treatment. The aOR was 1.01.

Among HIV-infected individuals, factors independently associated with a lack of cancer treatment included low CD4 count, male sex with injection drug use as mode of HIV exposure, age 45 to 64 years, black race, and distant or unknown cancer stage.

“In my clinical experience, I have seen uncertainty surrounding treatment of HIV-infected cancer patients,” Dr Suneja said. “Patients with HIV have typically been excluded from clinical trials, and, therefore, oncologists do not know if the best available treatments are equally safe and effective in those with HIV.”

“Many oncologists rely on guidelines based on such trials for treatment decision-making, and, in the absence of guidance, they may elect not to treat HIV-infected cancer patients due to concerns about adverse side effects or poor survival. This could help explain, in part, why many HIV-positive cancer patients are not receiving appropriate cancer care.”

Therefore, Dr Suneja and her colleagues recommend that cancer trials begin enrolling HIV-infected patients and cancer management guidelines incorporate recommendations for HIV-infected patients.

HIV budding from a cultured

lymphocyte; Credit: CDC

Cancer patients infected with HIV are less likely than their uninfected peers to receive cancer treatment, according to research published in the Journal of Clinical Oncology.

Results showed that HIV-positive patients were roughly twice as likely to go untreated for lymphomas and other cancers.

The researchers believe a lack of clinical trial data and treatment guidelines for HIV patients with cancer may contribute to this health disparity.

To assess the role of HIV status on cancer treatment, Gita Suneja, MD, of the University of Pennsylvania in Philadelphia, and her colleagues used data from the National Cancer Institute’s HIV/AIDS Cancer Match Study.

This included 3045 HIV-infected patients and 1,087,648 uninfected patients. The patients had been diagnosed with Hodgkin lymphoma, diffuse large B-cell lymphoma, or cervical, lung, anal, prostate, colorectal, or breast cancer from 1996 through 2010.

For each cancer type, the researchers assessed the relationship between HIV status and cancer treatment, adjusted for cancer stage, sex, age at cancer diagnosis, race/ethnicity, year of cancer diagnosis, and US state.

For all but 1 cancer type, there was a significantly higher proportion of HIV-infected patients who did not receive cancer treatment when compared with uninfected patients.

The adjusted odds ratios (aORs) were 1.67 for diffuse large B-cell lymphoma, 1.77 for Hodgkin lymphoma, 1.60 for cervical cancer, 1.79 for prostate cancer, 1.81 for breast cancer, 2.18 for lung cancer, and 2.27 for colorectal cancer.

Anal cancer was the only malignancy for which HIV status did not appear to impact treatment. The aOR was 1.01.

Among HIV-infected individuals, factors independently associated with a lack of cancer treatment included low CD4 count, male sex with injection drug use as mode of HIV exposure, age 45 to 64 years, black race, and distant or unknown cancer stage.

“In my clinical experience, I have seen uncertainty surrounding treatment of HIV-infected cancer patients,” Dr Suneja said. “Patients with HIV have typically been excluded from clinical trials, and, therefore, oncologists do not know if the best available treatments are equally safe and effective in those with HIV.”

“Many oncologists rely on guidelines based on such trials for treatment decision-making, and, in the absence of guidance, they may elect not to treat HIV-infected cancer patients due to concerns about adverse side effects or poor survival. This could help explain, in part, why many HIV-positive cancer patients are not receiving appropriate cancer care.”

Therefore, Dr Suneja and her colleagues recommend that cancer trials begin enrolling HIV-infected patients and cancer management guidelines incorporate recommendations for HIV-infected patients.

Red blood cells

Researchers say they’ve modified red blood cells (RBCs) to carry a range of payloads—from drugs to vaccines to imaging agents.

“We wanted to create high-value red cells that do more than simply carry oxygen,” said study author Harvey Lodish, PhD, of the Whitehead Institute in Cambridge, Massachusetts.

“Here, we’ve laid out the technology to make mouse and human red blood cells in culture that can express what we want and potentially be used for therapeutic or diagnostic purposes.”

Dr Lodish and his colleagues detailed the technology in Proceedings of the National Academy of Sciences.

The team noted that RBCs are an attractive vehicle for a variety of reasons, including their abundance and their long lifespan.

Perhaps most importantly, during RBC production, progenitor cells jettison their nuclei and all DNA therein. Without a nucleus, a mature RBC lacks any genetic material or any signs of earlier genetic manipulation that could result in tumor formation or other adverse effects.

Exploiting this characteristic, Dr Lodish and his colleagues introduced into early stage RBC progenitors genes coding for specific, slightly modified, normal red cell surface proteins.

As the RBCs approach maturity and enucleate, the proteins remain on the cell surface, where they are modified by a protein-labeling technique known as sortagging.

The technique relies on the bacterial enzyme sortase A to establish a strong chemical bond between the surface protein and a substance of choice, be it a small-molecule therapeutic or an antibody capable of binding a toxin. The modifications leave the cells and their surfaces unharmed.

“Because the modified human red blood cells can circulate in the body for up to 4 months, one could envision a scenario in which the cells are used to introduce antibodies that neutralize a toxin,” said Hidde L. Ploegh, PhD, also of the Whitehead Institute. “The result would be long-lasting reserves of antitoxin antibodies.”

The approach has captured the attention of the US military and its Defense Advanced Research Projects Agency, which is supporting the research in the interest of developing treatments or vaccines effective against biological weapons.

Dr Lodish believes the applications are potentially vast and may include RBCs modified to bind and remove bad cholesterol from the bloodstream, carry clot-busting proteins to treat ischemic strokes or deep-vein thrombosis, or deliver anti-inflammatory antibodies to alleviate chronic inflammation.

Dr Ploegh said there is evidence to suggest that modified RBCs could be used to suppress the unwanted immune response that often accompanies treatment with protein-based therapies.

He is exploring whether these RBCs could be used to prime the immune system to allow patients to better tolerate treatment with such therapies.

Red blood cells

Researchers say they’ve modified red blood cells (RBCs) to carry a range of payloads—from drugs to vaccines to imaging agents.

“We wanted to create high-value red cells that do more than simply carry oxygen,” said study author Harvey Lodish, PhD, of the Whitehead Institute in Cambridge, Massachusetts.

“Here, we’ve laid out the technology to make mouse and human red blood cells in culture that can express what we want and potentially be used for therapeutic or diagnostic purposes.”

Dr Lodish and his colleagues detailed the technology in Proceedings of the National Academy of Sciences.

The team noted that RBCs are an attractive vehicle for a variety of reasons, including their abundance and their long lifespan.

Perhaps most importantly, during RBC production, progenitor cells jettison their nuclei and all DNA therein. Without a nucleus, a mature RBC lacks any genetic material or any signs of earlier genetic manipulation that could result in tumor formation or other adverse effects.

Exploiting this characteristic, Dr Lodish and his colleagues introduced into early stage RBC progenitors genes coding for specific, slightly modified, normal red cell surface proteins.

As the RBCs approach maturity and enucleate, the proteins remain on the cell surface, where they are modified by a protein-labeling technique known as sortagging.

The technique relies on the bacterial enzyme sortase A to establish a strong chemical bond between the surface protein and a substance of choice, be it a small-molecule therapeutic or an antibody capable of binding a toxin. The modifications leave the cells and their surfaces unharmed.

“Because the modified human red blood cells can circulate in the body for up to 4 months, one could envision a scenario in which the cells are used to introduce antibodies that neutralize a toxin,” said Hidde L. Ploegh, PhD, also of the Whitehead Institute. “The result would be long-lasting reserves of antitoxin antibodies.”

The approach has captured the attention of the US military and its Defense Advanced Research Projects Agency, which is supporting the research in the interest of developing treatments or vaccines effective against biological weapons.

Dr Lodish believes the applications are potentially vast and may include RBCs modified to bind and remove bad cholesterol from the bloodstream, carry clot-busting proteins to treat ischemic strokes or deep-vein thrombosis, or deliver anti-inflammatory antibodies to alleviate chronic inflammation.

Dr Ploegh said there is evidence to suggest that modified RBCs could be used to suppress the unwanted immune response that often accompanies treatment with protein-based therapies.

He is exploring whether these RBCs could be used to prime the immune system to allow patients to better tolerate treatment with such therapies.

Red blood cells

Researchers say they’ve modified red blood cells (RBCs) to carry a range of payloads—from drugs to vaccines to imaging agents.

“We wanted to create high-value red cells that do more than simply carry oxygen,” said study author Harvey Lodish, PhD, of the Whitehead Institute in Cambridge, Massachusetts.

“Here, we’ve laid out the technology to make mouse and human red blood cells in culture that can express what we want and potentially be used for therapeutic or diagnostic purposes.”

Dr Lodish and his colleagues detailed the technology in Proceedings of the National Academy of Sciences.

The team noted that RBCs are an attractive vehicle for a variety of reasons, including their abundance and their long lifespan.

Perhaps most importantly, during RBC production, progenitor cells jettison their nuclei and all DNA therein. Without a nucleus, a mature RBC lacks any genetic material or any signs of earlier genetic manipulation that could result in tumor formation or other adverse effects.

Exploiting this characteristic, Dr Lodish and his colleagues introduced into early stage RBC progenitors genes coding for specific, slightly modified, normal red cell surface proteins.

As the RBCs approach maturity and enucleate, the proteins remain on the cell surface, where they are modified by a protein-labeling technique known as sortagging.

The technique relies on the bacterial enzyme sortase A to establish a strong chemical bond between the surface protein and a substance of choice, be it a small-molecule therapeutic or an antibody capable of binding a toxin. The modifications leave the cells and their surfaces unharmed.

“Because the modified human red blood cells can circulate in the body for up to 4 months, one could envision a scenario in which the cells are used to introduce antibodies that neutralize a toxin,” said Hidde L. Ploegh, PhD, also of the Whitehead Institute. “The result would be long-lasting reserves of antitoxin antibodies.”

The approach has captured the attention of the US military and its Defense Advanced Research Projects Agency, which is supporting the research in the interest of developing treatments or vaccines effective against biological weapons.

Dr Lodish believes the applications are potentially vast and may include RBCs modified to bind and remove bad cholesterol from the bloodstream, carry clot-busting proteins to treat ischemic strokes or deep-vein thrombosis, or deliver anti-inflammatory antibodies to alleviate chronic inflammation.

Dr Ploegh said there is evidence to suggest that modified RBCs could be used to suppress the unwanted immune response that often accompanies treatment with protein-based therapies.

He is exploring whether these RBCs could be used to prime the immune system to allow patients to better tolerate treatment with such therapies.

Proton pump inhibitors affect the size, relative acidity, and position of the acid pocket in gastroesophageal reflux patients, reported Dr. Wout O. Rohof and his colleagues.

"If one accepts that the acid pocket is still the source of the refluxate during PPI use, therapeutic strategies directly intervening with the acid pocket possibly may prove effective in preventing persistent symptoms on PPI," they wrote in the July issue of Clinical Gastroenterology and Hepatology News (doi.org/10.1016/j.cgh.2014.04.003-).

© nebari/Thinkstock

"This insight is of great importance because in approximately 30% of patients PPI therapy fails to resolve symptoms, either partially or completely," they added.

Dr. Rohof of the Academic Medical Center in Amsterdam and his colleagues looked at 36 patients with gastroesophageal reflux disease (GERD) confirmed by the presence of esophagitis on endoscopy and/or impedance-pH-metry with an acid exposure of more than 4.5%, plus usual GERD symptoms.

Eighteen patients were on PPIs; the remainder had been off PPIs for at least 1 week prior to the study; eight PPI cohort patients used omeprazole, five used pantoprazole, and five used esomeprazole, with dosages varying from 20 mg (one patient), to 40 mg (eight patients), to 40 mg twice daily (nine patients).

All patients were fed a standardized meal of orange juice and pancakes; afterward, concurrent scintigraphy, high-resolution manometry, and pH-impedance recordings were acquired for 105 minutes.

At the study’s conclusion, the acid pocket – a floating pool of acid on top of ingested food, visualized on scintigraphy after patients were injected with a radioisotope – was aspirated for analysis of its pH level.

The authors found that overall, while the total number of reflux episodes was similar for both PPI and non-PPI cohorts (15 vs. 14; P = .81), "As expected, the number of acid reflux episodes was lower on PPI (4.5 vs. 2.0; P = .04)."

Only two patients in the entire cohort did not demonstrate an acid pocket on scintigraphy; both were taking PPIs.

Of the remaining patients, the size of the acid pocket was significantly less among PPI patients than their counterparts (10 cm² vs. 15 cm²; P less than .01).

Moreover, when the acid pocket was aspirated at the conclusion of the study through the manometry catheter, the pH of the aspirated acid pocket fluid was significantly higher among PPI patients, compared with those not taking the drug (3.9 vs.0.9; P less than .001).

Finally, the investigators looked at the location of the acid pocket, which has also been shown to correlate with reflux episodes.

Their data showed that PPI patients were more likely to have the pocket located below the level of the diaphragm (60%), compared with patients not on PPI therapy (40%; P = .04).

This was especially important since pockets at this level correlated with only a 7% and 15% risk of acidic reflux events in PPI and non-PPI patients, respectively; in comparison, pockets in the hiatus and higher were associated with much greater rates of acidic reflux for both PPI and non-PPI patients, though the rates were lower among the former.

The authors disclosed no conflicts of interest or outside funding.

Proton pump inhibitors affect the size, relative acidity, and position of the acid pocket in gastroesophageal reflux patients, reported Dr. Wout O. Rohof and his colleagues.

"If one accepts that the acid pocket is still the source of the refluxate during PPI use, therapeutic strategies directly intervening with the acid pocket possibly may prove effective in preventing persistent symptoms on PPI," they wrote in the July issue of Clinical Gastroenterology and Hepatology News (doi.org/10.1016/j.cgh.2014.04.003-).

© nebari/Thinkstock

"This insight is of great importance because in approximately 30% of patients PPI therapy fails to resolve symptoms, either partially or completely," they added.

Dr. Rohof of the Academic Medical Center in Amsterdam and his colleagues looked at 36 patients with gastroesophageal reflux disease (GERD) confirmed by the presence of esophagitis on endoscopy and/or impedance-pH-metry with an acid exposure of more than 4.5%, plus usual GERD symptoms.

Eighteen patients were on PPIs; the remainder had been off PPIs for at least 1 week prior to the study; eight PPI cohort patients used omeprazole, five used pantoprazole, and five used esomeprazole, with dosages varying from 20 mg (one patient), to 40 mg (eight patients), to 40 mg twice daily (nine patients).

All patients were fed a standardized meal of orange juice and pancakes; afterward, concurrent scintigraphy, high-resolution manometry, and pH-impedance recordings were acquired for 105 minutes.

At the study’s conclusion, the acid pocket – a floating pool of acid on top of ingested food, visualized on scintigraphy after patients were injected with a radioisotope – was aspirated for analysis of its pH level.

The authors found that overall, while the total number of reflux episodes was similar for both PPI and non-PPI cohorts (15 vs. 14; P = .81), "As expected, the number of acid reflux episodes was lower on PPI (4.5 vs. 2.0; P = .04)."

Only two patients in the entire cohort did not demonstrate an acid pocket on scintigraphy; both were taking PPIs.

Of the remaining patients, the size of the acid pocket was significantly less among PPI patients than their counterparts (10 cm² vs. 15 cm²; P less than .01).

Moreover, when the acid pocket was aspirated at the conclusion of the study through the manometry catheter, the pH of the aspirated acid pocket fluid was significantly higher among PPI patients, compared with those not taking the drug (3.9 vs.0.9; P less than .001).

Finally, the investigators looked at the location of the acid pocket, which has also been shown to correlate with reflux episodes.

Their data showed that PPI patients were more likely to have the pocket located below the level of the diaphragm (60%), compared with patients not on PPI therapy (40%; P = .04).

This was especially important since pockets at this level correlated with only a 7% and 15% risk of acidic reflux events in PPI and non-PPI patients, respectively; in comparison, pockets in the hiatus and higher were associated with much greater rates of acidic reflux for both PPI and non-PPI patients, though the rates were lower among the former.

The authors disclosed no conflicts of interest or outside funding.

Proton pump inhibitors affect the size, relative acidity, and position of the acid pocket in gastroesophageal reflux patients, reported Dr. Wout O. Rohof and his colleagues.

"If one accepts that the acid pocket is still the source of the refluxate during PPI use, therapeutic strategies directly intervening with the acid pocket possibly may prove effective in preventing persistent symptoms on PPI," they wrote in the July issue of Clinical Gastroenterology and Hepatology News (doi.org/10.1016/j.cgh.2014.04.003-).

© nebari/Thinkstock

"This insight is of great importance because in approximately 30% of patients PPI therapy fails to resolve symptoms, either partially or completely," they added.

Dr. Rohof of the Academic Medical Center in Amsterdam and his colleagues looked at 36 patients with gastroesophageal reflux disease (GERD) confirmed by the presence of esophagitis on endoscopy and/or impedance-pH-metry with an acid exposure of more than 4.5%, plus usual GERD symptoms.

Eighteen patients were on PPIs; the remainder had been off PPIs for at least 1 week prior to the study; eight PPI cohort patients used omeprazole, five used pantoprazole, and five used esomeprazole, with dosages varying from 20 mg (one patient), to 40 mg (eight patients), to 40 mg twice daily (nine patients).

All patients were fed a standardized meal of orange juice and pancakes; afterward, concurrent scintigraphy, high-resolution manometry, and pH-impedance recordings were acquired for 105 minutes.

At the study’s conclusion, the acid pocket – a floating pool of acid on top of ingested food, visualized on scintigraphy after patients were injected with a radioisotope – was aspirated for analysis of its pH level.

The authors found that overall, while the total number of reflux episodes was similar for both PPI and non-PPI cohorts (15 vs. 14; P = .81), "As expected, the number of acid reflux episodes was lower on PPI (4.5 vs. 2.0; P = .04)."

Only two patients in the entire cohort did not demonstrate an acid pocket on scintigraphy; both were taking PPIs.

Of the remaining patients, the size of the acid pocket was significantly less among PPI patients than their counterparts (10 cm² vs. 15 cm²; P less than .01).

Moreover, when the acid pocket was aspirated at the conclusion of the study through the manometry catheter, the pH of the aspirated acid pocket fluid was significantly higher among PPI patients, compared with those not taking the drug (3.9 vs.0.9; P less than .001).

Finally, the investigators looked at the location of the acid pocket, which has also been shown to correlate with reflux episodes.

Their data showed that PPI patients were more likely to have the pocket located below the level of the diaphragm (60%), compared with patients not on PPI therapy (40%; P = .04).

This was especially important since pockets at this level correlated with only a 7% and 15% risk of acidic reflux events in PPI and non-PPI patients, respectively; in comparison, pockets in the hiatus and higher were associated with much greater rates of acidic reflux for both PPI and non-PPI patients, though the rates were lower among the former.

The authors disclosed no conflicts of interest or outside funding.

Series Editor: Arthur T. Skarin, MD, FACP, FCCP

Melanoma is the sixth most common cancer in the United States and the leading cause of deaths among all cutaneous malignancies. In 2012, it was estimated that approximately 75,000 individuals were diagnosed with melanoma and more than 9000 died. The incidence of melanoma is rising the fastest among all major malignancies, and the lifetime risk of melanoma among men and women now exceeds 1 in 68, as compared with 1:1500 in 1930.4 The incidence of melanoma is predicted to continue increasing, and there has been no corresponding decrease in mortality. This case-based review summarizes the etiology, risk factors, clinical presentation, and management of cutaneous melanomas, which comprise the majority of melanoma cases. The biology and management for other noncutaneous melanomas (such as mucosal or ocular melanomas) are beyond the scope of this review.

To read the full article in PDF:

Click here

Series Editor: Arthur T. Skarin, MD, FACP, FCCP

Melanoma is the sixth most common cancer in the United States and the leading cause of deaths among all cutaneous malignancies. In 2012, it was estimated that approximately 75,000 individuals were diagnosed with melanoma and more than 9000 died. The incidence of melanoma is rising the fastest among all major malignancies, and the lifetime risk of melanoma among men and women now exceeds 1 in 68, as compared with 1:1500 in 1930.4 The incidence of melanoma is predicted to continue increasing, and there has been no corresponding decrease in mortality. This case-based review summarizes the etiology, risk factors, clinical presentation, and management of cutaneous melanomas, which comprise the majority of melanoma cases. The biology and management for other noncutaneous melanomas (such as mucosal or ocular melanomas) are beyond the scope of this review.

To read the full article in PDF:

Click here

Series Editor: Arthur T. Skarin, MD, FACP, FCCP

Melanoma is the sixth most common cancer in the United States and the leading cause of deaths among all cutaneous malignancies. In 2012, it was estimated that approximately 75,000 individuals were diagnosed with melanoma and more than 9000 died. The incidence of melanoma is rising the fastest among all major malignancies, and the lifetime risk of melanoma among men and women now exceeds 1 in 68, as compared with 1:1500 in 1930.4 The incidence of melanoma is predicted to continue increasing, and there has been no corresponding decrease in mortality. This case-based review summarizes the etiology, risk factors, clinical presentation, and management of cutaneous melanomas, which comprise the majority of melanoma cases. The biology and management for other noncutaneous melanomas (such as mucosal or ocular melanomas) are beyond the scope of this review.

To read the full article in PDF:

Click here

Also known as “domestic violence” and “spouse abuse,” intimate partner violence (IPV) is now the term defined by the US Centers for Disease Control and Prevention to include physical violence, sexual violence, threats of physical or sexual violence, and psychological or emotional abuse by a current or former spouse, common-law spouse, nonmarital dating partner, or boyfriend or girlfriend of the same or opposite sex.¹ Although IPV is often hidden or kept secret by those affected, it is a highly prevalent issue, especially in women. Knowing how to broach the subject and provide appropriate support in a caring and nonjudgmental manner are the keys to helping a woman move forward in her readiness and ability to improve her situation.

See related patient information

ONE IN THREE WOMEN EXPERIENCES IPV IN HER LIFE

As clinicians, we have all seen patients who have been affected by IPV—even if we did not realize it at the time. Indeed, 36% of women in the United States (approximately 42.4 million) have experienced rape, physical violence, or stalking by an intimate partner in their lifetime, and 6% (approximately 7 million) have experienced these forms of IPV within the past 12 months.²

ASSOCIATION WITH MURDER

From 30% to 70% of women who are murdered are killed by a current or former intimate partner.^3,4 Of those killed by their partner, two-thirds had previously reported physical assault, and 83% had been threatened by the man who eventually killed them.⁴ In another study, 44% of IPV murder victims had presented to an emergency department within 2 years of their murder.⁵

PHYSICAL EFFECTS NOT ALWAYS APPARENT

Although 41% of women who experience IPV suffer physical injury from their attacks, only 28% of those who are injured seek medical care.⁶ Because injuries are often absent or no longer apparent when an IPV victim decides to get help, it is important to be aware of the clinical signs associated with IPV:

• Gastrointestinal disorders⁷
• Depression⁸
• Anxiety
• Chronic pain syndromes⁹
• Substance abuse
• Suicidal ideation.¹⁰

In women of childbearing age, IPV is associated with unintended pregnancy, sexually transmitted infections, condom non-use,^11,12 inconsistent condom use,¹³ and fear of talking about condom use.^11,12 Coerced sexual experiences (eg, sexual intercourse that was not wanted or consented to) are common, with 28% to 42% of college women reporting at least one such experience. In more than three quarters of women who have been sexually assaulted, the first experience occurred before age 25.^14,15

One-quarter of women ages 16 to 29 have experienced reproductive coercion, which includes birth control sabotage or pregnancy coercion by the active male partner.¹⁶ Among women reporting birth control sabotage, 79% had also been victims of physical or sexual IPV.¹⁶

The cost of providing health care to women experiencing IPV is 1.4 to 2.5 times higher than that of the nonabused population. Studies have shown that female victims of both physical and nonphysical (eg, emotional or verbal) IPV are more likely to use emergency, mental health, and outpatient health care services. The economic toll of IPV, including health care and costs from lost productivity and premature death, ranges from $2.3 to $8.3 billion per year.^17,18

ASK FEMALE PATIENTS ABOUT IPV

In the early 1990s, various medical organizations began issuing policy statements that endorsed screening for IPV.^19–22 Since 1992, the Joint Commission on Accreditation of Healthcare Organizations has required hospitals and clinics to provide assistance to those experiencing IPV.²³ Although the United States Preventive Services Task Force initially found insufficient evidence to support regular IPV screening in health care settings,^24–27 the group reversed its position in 2012 after a review of more recent studies. The group now recommends that clinicians address IPV with all women of childbearing age.²⁸

A Cochrane review found that IPV screening increased identification of IPV survivors.²⁹ Female participants in many studies wanted clinicians to ask routinely about violence and to provide information on community and legal resources.^30,31

How should we ask about IPV?

Although various sets of screening questions and tools are available, no one instrument is considered better than the others. However, women experiencing IPV have specific preferences regarding how they want clinicians to ask and talk about the topic. In one survey, women who had experienced IPV preferred that clinicians ask about it as part of the complete medical history, as long as it did not create “an atmosphere of interrogation.”³²

The style in which a clinician asks about IPV may make a difference as well. In focus groups, immigrant Latina and Asian women who had experienced IPV stated that clinicians could facilitate open communication by initiating the discussion and exhibiting compassionate and supportive behavior during the visit.³³ Being able to see the same clinician at each visit also enhanced clinician-patient communication.³³

In a study of IPV screening in emergency room settings, most clinicians asked about IPV in a perfunctory, direct manner—generally some variant of, “Are you a victim of domestic violence?” In this study, patient IPV disclosure occurred more often when clinicians used an open-ended approach such as, “Tell me what happened,” or when clinicians probed for possible IPV (eg, “What do you think may be causing some of this stress?”).³⁴

In a focus group, female IPV survivors described feeling stigmatized or invalidated when clinicians were condescending, judgmental, or dismissive.³⁵ Nonjudgmental and supportive communication decreased the women’s sense of isolation and led to positive outcomes such as increased awareness of IPV as a problem, decreased isolation, and feeling that the clinician cared.³⁵

When addressing IPV, clinicians should explain why they are asking about it because it allows the woman to understand the context of the inquiry and to feel more comfortable about disclosing IPV. If the query is a regular part of a general screening or history-taking, for example, they should frame the question to make that point apparent. For example, “Because we know that many women in the United States experience physical, sexual or emotional violence from their romantic partners, I like to ask all of my patients whether they have been hurt or have felt threatened or afraid in a current or past relationship.”

In situations in which clinicians are concerned about IPV with a particular patient, they should explicitly share their concerns and desire to help the patient. One IPV survivor offered this advice: “Just look at the patient like she is your friend. Call her by her name. For instance, say ‘Sally, is he hurting you? Are you having problems? If you need help, I have some [phone] numbers.’ Personalize the encounter.”

It is also important to address IPV in a manner that ensures the patient’s safety, confidentiality, and dignity. When having this type of sensitive conversation, the patient should ideally be clothed and alone—without others present, particularly her partner. Professional interpreters should be available to women who do not speak English. The clinician should maintain eye contact, smile to communicate friendliness, and use a supportive tone.³⁶

Just asking may be an intervention

Qualitative studies have suggested that just the act of asking about IPV in a nonjudgmental and compassionate manner is helpful to women experiencing IPV.^35,37 Doing so not only helps women recognize the abuse, but also begins to decrease their sense of isolation and increase their awareness of helpful resources. It also gives the patient a sense that the clinician cares about her situation.³⁵ As a result, experts have begun to recommend that health clinicians view asking about IPV not merely as a screening tool, but as a potentially therapeutic intervention in and of itself.^35,37,38

HOW TO HELP

What to do when a woman discloses IPV

Female survivors, advocates, and health care clinicians who care for abused women suggest responding to a positive disclosure of IPV by providing the following:

Validation. The IPV perpetrator will often attempt to justify the violence and abuse by shifting some of the blame or responsibility for the violence onto the victim. This “brainwashing” leads to self-blame and a diminished sense of self-worth. However, clinicians can help reverse this mindset by acknowledging the woman’s disclosure and emphasizing that she did not deserve the abuse or violence. An example of such a statement is, “I am so very sorry that you went through that with your partner. You definitely did not deserve that. No one should ever be hurt by or afraid of the people who are supposed to love them.” Providing validation helps women recognize that the violence was a problem they did not deserve.^38,39

Support. Women who have experienced IPV appreciate feeling supported and cared for by their health care clinician. Even if the patient is not ready to take any definitive action regarding her relationship or situation, knowing that her clinician and the health care setting are resources and sources of support is both comforting and empowering.^35,40 Clinicians can communicate this support by stating, “I want you to know that whatever happens and whatever you decide, we are here for you.”

Respect for autonomy. Women experiencing IPV best understand their own situation and its various complexities and so they know best what they can do, cannot do, or need to do. As such, clinicians must respect a woman’s autonomy and preserve her ability to express her own needs and desires and make her own decisions. Prescribing a plan of action or giving commands to IPV victims could further perpetuate their sense of disempowerment and lack of control over their life.

Information. Providing referral information or hotline numbers to community domestic violence programs is helpful. However, not all women feel safe or comfortable taking printed brochures or written information with them because their abusive partner may find it. Thus, clinicians should ask if the patient can take the information safely or offer to write the numbers down without labeling them if she is afraid. The National Domestic Violence hotline is a 24-hour toll-free resource that will help women locate and contact shelters and other support services in their own community. The number, 1-800-799-SAFE (7233), is easy to memorize and thus is an easy resource to pass along quickly and safely. Other national organizations such as Futures Without Violence (formerly known as the Family Violence Prevention Fund) and the National Coalition Against Violence also provide links to local resources (Table 1).

Safety planning. Discussing the need for a safety plan will help the patient prepare for future abusive episodes. Even women who report that they are no longer in an abusive relationship should be asked about their current safety needs and concerns because they often remain in contact with abusive partners even after a relationship has ended.

When discussing safety planning, clinicians should ask the woman if she is currently safe or if she needs shelter. If she intends to return to or is still in contact with her batterer, ask if she has a plan for what to do or how to escape if the violence occurs again. Advise the patient to:

• Hide money so that she can leave quickly
• Make copies of birth certificates, immunization records, Social Security Number, and other important documents and keep them hidden and accessible
• Make a spare car key
• Have a list of hotline numbers
• Develop a code with friends, family, and neighbors that will let them know she needs immediate help.

Studies show that discussing safety-promoting behaviors increases the number of them that are used by IPV victims.⁴¹ A detailed list that can be shared with patients is provided in the patient information page that accompanies this article.⁴² Examples of personalized safety plans are available from the National Center on Domestic and Sexual Violence at its website, www.ncdsv.org/images/NCDSV_DVSafetyPlan_updated2013.pdf.

Danger assessment. Several researchers have examined potential risk factors associated with increased risk of homicide.⁴³ Table 2 lists some of the characteristics associated with an increased risk of homicide in IPV situations.⁴² From this work, a danger assessment tool and scoring system has been developed. This tool and training on how to use it are available for free at www.dangerassessment.org. Although there are currently no outcome data on the benefits or risks of using this instrument, its objective is to increase women’s awareness of their danger level and individualize their safety counseling.

Proper documentation. Victim advocates and lawyers working on behalf of IPV victims emphasize that documentation by a medical provider can help a woman with her legal case. This documentation should be clear, legible, and as detailed as possible. These details should include a patient’s own words set off by quotation marks, a description or body map illustrating associated injuries or physical signs corroborating the violence, and a description of the patient’s demeanor or signs of emotion. Clinicians should avoid legal terms such as “alleges” or “alleged perpetrator” and should either define or avoid abbreviations that may be considered ambiguous in a legal proceeding (eg, clinicians should write out the words “domestic violence” or “intimate partner violence” rather than using “DV” or “IPV”).⁴⁴ Most states have passed laws that prevent insurance companies from discriminating against IPV victims; insurance companies can no longer deny women coverage for seeking care related to IPV.⁴⁵

A nonthreatening physical examination. Women who have experienced physical or sexual violence may feel anxious or experience added trauma during certain portions of the physical examination. Women who have been raped or otherwise sexually abused may have difficulty tolerating a pelvic examination, for example. Others who have been choked or grabbed by the neck may experience distress during palpation of the thyroid or cervical lymph nodes. The oropharyngeal examination may be challenging for women who have experienced forced oral sex or who may have had objects such as the barrel of a gun forced into their mouth. Asking women who have experienced IPV what aspects of the physical examination they may find difficult and how this could be made easier allows the patient and clinician to work together to develop strategies for or alternatives to necessary examinations or testing.

Before starting an examination, clinicians should explain what will happen and then ask the patient for her permission before moving on to the next step. Doing so creates a sense of control in an otherwise challenging and potentially traumatizing examination.

Disclosure of mandatory IPV reporting. Many states require health care providers to report any injuries caused by a weapon or criminal act to police or other official institutions.^45,46 Several of these states specify that this reporting should occur during an IPV evaluation.

Mandatory reporting of IPV to police is highly controversial.^47–49 Opponents of these laws argue that they do not benefit victims because they do not respect autonomy, they violate patient-clinician confidentiality, and they violate informed consent.⁴⁷ Female IPV victims indicate that they would be less likely to disclose IPV and seek help if they knew it had to be reported.^50–53 In a survey of California physicians, 59% stated that they might not comply with reporting laws if the patient objected.⁵⁴

In states with mandatory reporting laws, clinicians can advocate for their patients by disclosing whether IPV must be reported before beginning their examination. The Michigan Coalition Against Domestic Violence devised this sample statement:

“I do have to let you know that under state law, I am obligated to make a police report to (name police agency with jurisdiction over the facility), if I/we are treating someone for any injury sustained by means of violence (tailor this information to the specifics of your state law). So, if you would have any concerns about that, I would encourage you to speak with one of the domestic violence advocates/counselors at (DV agency), who are able to provide confidential services and help without being required to make a police report.”⁵⁵

The Compendium of State Statutes and Polices on Domestic Violence and Health Care by Futures Without Violence is an excellent reference that describes current state laws and policies regarding domestic violence and includes descriptions of the specific characteristics of each state’s mandatory reporting laws and their implications for health care providers. A copy can be downloaded from www.futureswithout-violence.org/content/features/detail/1584/.

What not to do

Clinicians should not ignore or minimize the extent of IPV, make excuses for the batterer, or blame the woman.^32,56,57 They also should not inadvertently blame or criticize the woman by asking her, “What did you do to deserve this?” or “Why don’t you just leave?”⁵⁷

While leaving a violent relationship is an obvious solution, many women experiencing IPV are either unwilling or unable to do so. In fact, leaving the batterer can be just as dangerous as staying. In a North Carolina study, half of all women killed by their partner had divorced or broken up with the partner immediately before the murder.⁴

What to do when a woman does not disclose IPV

Women who have experienced IPV often deny the violence to others out of fear. So a denial of violence, even in highly suspicious cases, can be expected. Abused patients often want help but are confused and afraid to ask for it.^58,59 Providing easy and anonymous access to IPV information and resources through posters, flyers, brochures, and booklets will allow any woman—regardless of disclosure—to obtain help.³⁶

In one IPV trial, all women in a family planning clinic who were in the intervention group were given information about IPV and how it can affect sexual and reproductive health, whether or not they disclosed. Compared with women in the control group, women who received the intervention—both those who did and did not experience IPV—were 63% more likely than those in the control group to end a relationship because they perceived it to be unhealthy or unsafe. In this case, all women—not just those who were victims—benefited from receiving information about IPV.⁶⁰

PROVIDERS’ SUPPORT MAKES A DIFFERENCE, IMPROVES OUTCOMES

Patients may seek help for and find safety from IPV in stages or steps, and it may take them several months or even years to do so.^61–63 In this sense, then, IPV is an issue that is not likely to be “cured” or changed in a single medical visit. In addition, a single visit may not be associated with direct health and safety outcomes. However, a patient is more likely to make changes if she has supportive and informative interaction with a caring, nonjudgmental clinician who can increase her awareness of IPV and IPV resources and promote an improved sense of self-efficacy or perceived power.⁴⁰

For example, in a study in which health clinicians expressed concern about potential IPV health effects and offered support services such as counseling, 67% of women used one of those resources at least once.⁴⁰ In another study, women who talked to a health care provider about their abuse were almost four times more likely to use an IPV intervention (eg, advocacy, shelter, restraining order) than women who did not talk to their provider. Those who used an IPV intervention were 2.6 times more likely to leave their abusive relationship, and those who left reported improved physical health.⁶⁴

Thus, health care providers can have a positive effect by addressing this complex and difficult issue. The power and influence of a provider’s kindness, empathy, and support cannot be overestimated in their ability to improve the safety and well-being of women dealing with IPV.

Also known as “domestic violence” and “spouse abuse,” intimate partner violence (IPV) is now the term defined by the US Centers for Disease Control and Prevention to include physical violence, sexual violence, threats of physical or sexual violence, and psychological or emotional abuse by a current or former spouse, common-law spouse, nonmarital dating partner, or boyfriend or girlfriend of the same or opposite sex.¹ Although IPV is often hidden or kept secret by those affected, it is a highly prevalent issue, especially in women. Knowing how to broach the subject and provide appropriate support in a caring and nonjudgmental manner are the keys to helping a woman move forward in her readiness and ability to improve her situation.

See related patient information

ONE IN THREE WOMEN EXPERIENCES IPV IN HER LIFE

As clinicians, we have all seen patients who have been affected by IPV—even if we did not realize it at the time. Indeed, 36% of women in the United States (approximately 42.4 million) have experienced rape, physical violence, or stalking by an intimate partner in their lifetime, and 6% (approximately 7 million) have experienced these forms of IPV within the past 12 months.²

ASSOCIATION WITH MURDER

From 30% to 70% of women who are murdered are killed by a current or former intimate partner.^3,4 Of those killed by their partner, two-thirds had previously reported physical assault, and 83% had been threatened by the man who eventually killed them.⁴ In another study, 44% of IPV murder victims had presented to an emergency department within 2 years of their murder.⁵

PHYSICAL EFFECTS NOT ALWAYS APPARENT

Although 41% of women who experience IPV suffer physical injury from their attacks, only 28% of those who are injured seek medical care.⁶ Because injuries are often absent or no longer apparent when an IPV victim decides to get help, it is important to be aware of the clinical signs associated with IPV:

• Gastrointestinal disorders⁷
• Depression⁸
• Anxiety
• Chronic pain syndromes⁹
• Substance abuse
• Suicidal ideation.¹⁰

In women of childbearing age, IPV is associated with unintended pregnancy, sexually transmitted infections, condom non-use,^11,12 inconsistent condom use,¹³ and fear of talking about condom use.^11,12 Coerced sexual experiences (eg, sexual intercourse that was not wanted or consented to) are common, with 28% to 42% of college women reporting at least one such experience. In more than three quarters of women who have been sexually assaulted, the first experience occurred before age 25.^14,15

One-quarter of women ages 16 to 29 have experienced reproductive coercion, which includes birth control sabotage or pregnancy coercion by the active male partner.¹⁶ Among women reporting birth control sabotage, 79% had also been victims of physical or sexual IPV.¹⁶

The cost of providing health care to women experiencing IPV is 1.4 to 2.5 times higher than that of the nonabused population. Studies have shown that female victims of both physical and nonphysical (eg, emotional or verbal) IPV are more likely to use emergency, mental health, and outpatient health care services. The economic toll of IPV, including health care and costs from lost productivity and premature death, ranges from $2.3 to $8.3 billion per year.^17,18

ASK FEMALE PATIENTS ABOUT IPV

In the early 1990s, various medical organizations began issuing policy statements that endorsed screening for IPV.^19–22 Since 1992, the Joint Commission on Accreditation of Healthcare Organizations has required hospitals and clinics to provide assistance to those experiencing IPV.²³ Although the United States Preventive Services Task Force initially found insufficient evidence to support regular IPV screening in health care settings,^24–27 the group reversed its position in 2012 after a review of more recent studies. The group now recommends that clinicians address IPV with all women of childbearing age.²⁸

A Cochrane review found that IPV screening increased identification of IPV survivors.²⁹ Female participants in many studies wanted clinicians to ask routinely about violence and to provide information on community and legal resources.^30,31

How should we ask about IPV?

Although various sets of screening questions and tools are available, no one instrument is considered better than the others. However, women experiencing IPV have specific preferences regarding how they want clinicians to ask and talk about the topic. In one survey, women who had experienced IPV preferred that clinicians ask about it as part of the complete medical history, as long as it did not create “an atmosphere of interrogation.”³²

The style in which a clinician asks about IPV may make a difference as well. In focus groups, immigrant Latina and Asian women who had experienced IPV stated that clinicians could facilitate open communication by initiating the discussion and exhibiting compassionate and supportive behavior during the visit.³³ Being able to see the same clinician at each visit also enhanced clinician-patient communication.³³

In a study of IPV screening in emergency room settings, most clinicians asked about IPV in a perfunctory, direct manner—generally some variant of, “Are you a victim of domestic violence?” In this study, patient IPV disclosure occurred more often when clinicians used an open-ended approach such as, “Tell me what happened,” or when clinicians probed for possible IPV (eg, “What do you think may be causing some of this stress?”).³⁴

In a focus group, female IPV survivors described feeling stigmatized or invalidated when clinicians were condescending, judgmental, or dismissive.³⁵ Nonjudgmental and supportive communication decreased the women’s sense of isolation and led to positive outcomes such as increased awareness of IPV as a problem, decreased isolation, and feeling that the clinician cared.³⁵

When addressing IPV, clinicians should explain why they are asking about it because it allows the woman to understand the context of the inquiry and to feel more comfortable about disclosing IPV. If the query is a regular part of a general screening or history-taking, for example, they should frame the question to make that point apparent. For example, “Because we know that many women in the United States experience physical, sexual or emotional violence from their romantic partners, I like to ask all of my patients whether they have been hurt or have felt threatened or afraid in a current or past relationship.”

In situations in which clinicians are concerned about IPV with a particular patient, they should explicitly share their concerns and desire to help the patient. One IPV survivor offered this advice: “Just look at the patient like she is your friend. Call her by her name. For instance, say ‘Sally, is he hurting you? Are you having problems? If you need help, I have some [phone] numbers.’ Personalize the encounter.”

It is also important to address IPV in a manner that ensures the patient’s safety, confidentiality, and dignity. When having this type of sensitive conversation, the patient should ideally be clothed and alone—without others present, particularly her partner. Professional interpreters should be available to women who do not speak English. The clinician should maintain eye contact, smile to communicate friendliness, and use a supportive tone.³⁶

Just asking may be an intervention

Qualitative studies have suggested that just the act of asking about IPV in a nonjudgmental and compassionate manner is helpful to women experiencing IPV.^35,37 Doing so not only helps women recognize the abuse, but also begins to decrease their sense of isolation and increase their awareness of helpful resources. It also gives the patient a sense that the clinician cares about her situation.³⁵ As a result, experts have begun to recommend that health clinicians view asking about IPV not merely as a screening tool, but as a potentially therapeutic intervention in and of itself.^35,37,38

HOW TO HELP

What to do when a woman discloses IPV

Female survivors, advocates, and health care clinicians who care for abused women suggest responding to a positive disclosure of IPV by providing the following:

Validation. The IPV perpetrator will often attempt to justify the violence and abuse by shifting some of the blame or responsibility for the violence onto the victim. This “brainwashing” leads to self-blame and a diminished sense of self-worth. However, clinicians can help reverse this mindset by acknowledging the woman’s disclosure and emphasizing that she did not deserve the abuse or violence. An example of such a statement is, “I am so very sorry that you went through that with your partner. You definitely did not deserve that. No one should ever be hurt by or afraid of the people who are supposed to love them.” Providing validation helps women recognize that the violence was a problem they did not deserve.^38,39

Support. Women who have experienced IPV appreciate feeling supported and cared for by their health care clinician. Even if the patient is not ready to take any definitive action regarding her relationship or situation, knowing that her clinician and the health care setting are resources and sources of support is both comforting and empowering.^35,40 Clinicians can communicate this support by stating, “I want you to know that whatever happens and whatever you decide, we are here for you.”

Respect for autonomy. Women experiencing IPV best understand their own situation and its various complexities and so they know best what they can do, cannot do, or need to do. As such, clinicians must respect a woman’s autonomy and preserve her ability to express her own needs and desires and make her own decisions. Prescribing a plan of action or giving commands to IPV victims could further perpetuate their sense of disempowerment and lack of control over their life.

Information. Providing referral information or hotline numbers to community domestic violence programs is helpful. However, not all women feel safe or comfortable taking printed brochures or written information with them because their abusive partner may find it. Thus, clinicians should ask if the patient can take the information safely or offer to write the numbers down without labeling them if she is afraid. The National Domestic Violence hotline is a 24-hour toll-free resource that will help women locate and contact shelters and other support services in their own community. The number, 1-800-799-SAFE (7233), is easy to memorize and thus is an easy resource to pass along quickly and safely. Other national organizations such as Futures Without Violence (formerly known as the Family Violence Prevention Fund) and the National Coalition Against Violence also provide links to local resources (Table 1).

Safety planning. Discussing the need for a safety plan will help the patient prepare for future abusive episodes. Even women who report that they are no longer in an abusive relationship should be asked about their current safety needs and concerns because they often remain in contact with abusive partners even after a relationship has ended.

When discussing safety planning, clinicians should ask the woman if she is currently safe or if she needs shelter. If she intends to return to or is still in contact with her batterer, ask if she has a plan for what to do or how to escape if the violence occurs again. Advise the patient to:

• Hide money so that she can leave quickly
• Make copies of birth certificates, immunization records, Social Security Number, and other important documents and keep them hidden and accessible
• Make a spare car key
• Have a list of hotline numbers
• Develop a code with friends, family, and neighbors that will let them know she needs immediate help.

Studies show that discussing safety-promoting behaviors increases the number of them that are used by IPV victims.⁴¹ A detailed list that can be shared with patients is provided in the patient information page that accompanies this article.⁴² Examples of personalized safety plans are available from the National Center on Domestic and Sexual Violence at its website, www.ncdsv.org/images/NCDSV_DVSafetyPlan_updated2013.pdf.

Danger assessment. Several researchers have examined potential risk factors associated with increased risk of homicide.⁴³ Table 2 lists some of the characteristics associated with an increased risk of homicide in IPV situations.⁴² From this work, a danger assessment tool and scoring system has been developed. This tool and training on how to use it are available for free at www.dangerassessment.org. Although there are currently no outcome data on the benefits or risks of using this instrument, its objective is to increase women’s awareness of their danger level and individualize their safety counseling.

Proper documentation. Victim advocates and lawyers working on behalf of IPV victims emphasize that documentation by a medical provider can help a woman with her legal case. This documentation should be clear, legible, and as detailed as possible. These details should include a patient’s own words set off by quotation marks, a description or body map illustrating associated injuries or physical signs corroborating the violence, and a description of the patient’s demeanor or signs of emotion. Clinicians should avoid legal terms such as “alleges” or “alleged perpetrator” and should either define or avoid abbreviations that may be considered ambiguous in a legal proceeding (eg, clinicians should write out the words “domestic violence” or “intimate partner violence” rather than using “DV” or “IPV”).⁴⁴ Most states have passed laws that prevent insurance companies from discriminating against IPV victims; insurance companies can no longer deny women coverage for seeking care related to IPV.⁴⁵

A nonthreatening physical examination. Women who have experienced physical or sexual violence may feel anxious or experience added trauma during certain portions of the physical examination. Women who have been raped or otherwise sexually abused may have difficulty tolerating a pelvic examination, for example. Others who have been choked or grabbed by the neck may experience distress during palpation of the thyroid or cervical lymph nodes. The oropharyngeal examination may be challenging for women who have experienced forced oral sex or who may have had objects such as the barrel of a gun forced into their mouth. Asking women who have experienced IPV what aspects of the physical examination they may find difficult and how this could be made easier allows the patient and clinician to work together to develop strategies for or alternatives to necessary examinations or testing.

Before starting an examination, clinicians should explain what will happen and then ask the patient for her permission before moving on to the next step. Doing so creates a sense of control in an otherwise challenging and potentially traumatizing examination.

Disclosure of mandatory IPV reporting. Many states require health care providers to report any injuries caused by a weapon or criminal act to police or other official institutions.^45,46 Several of these states specify that this reporting should occur during an IPV evaluation.

Mandatory reporting of IPV to police is highly controversial.^47–49 Opponents of these laws argue that they do not benefit victims because they do not respect autonomy, they violate patient-clinician confidentiality, and they violate informed consent.⁴⁷ Female IPV victims indicate that they would be less likely to disclose IPV and seek help if they knew it had to be reported.^50–53 In a survey of California physicians, 59% stated that they might not comply with reporting laws if the patient objected.⁵⁴

In states with mandatory reporting laws, clinicians can advocate for their patients by disclosing whether IPV must be reported before beginning their examination. The Michigan Coalition Against Domestic Violence devised this sample statement:

“I do have to let you know that under state law, I am obligated to make a police report to (name police agency with jurisdiction over the facility), if I/we are treating someone for any injury sustained by means of violence (tailor this information to the specifics of your state law). So, if you would have any concerns about that, I would encourage you to speak with one of the domestic violence advocates/counselors at (DV agency), who are able to provide confidential services and help without being required to make a police report.”⁵⁵

The Compendium of State Statutes and Polices on Domestic Violence and Health Care by Futures Without Violence is an excellent reference that describes current state laws and policies regarding domestic violence and includes descriptions of the specific characteristics of each state’s mandatory reporting laws and their implications for health care providers. A copy can be downloaded from www.futureswithout-violence.org/content/features/detail/1584/.

What not to do

Clinicians should not ignore or minimize the extent of IPV, make excuses for the batterer, or blame the woman.^32,56,57 They also should not inadvertently blame or criticize the woman by asking her, “What did you do to deserve this?” or “Why don’t you just leave?”⁵⁷

While leaving a violent relationship is an obvious solution, many women experiencing IPV are either unwilling or unable to do so. In fact, leaving the batterer can be just as dangerous as staying. In a North Carolina study, half of all women killed by their partner had divorced or broken up with the partner immediately before the murder.⁴

What to do when a woman does not disclose IPV

Women who have experienced IPV often deny the violence to others out of fear. So a denial of violence, even in highly suspicious cases, can be expected. Abused patients often want help but are confused and afraid to ask for it.^58,59 Providing easy and anonymous access to IPV information and resources through posters, flyers, brochures, and booklets will allow any woman—regardless of disclosure—to obtain help.³⁶

In one IPV trial, all women in a family planning clinic who were in the intervention group were given information about IPV and how it can affect sexual and reproductive health, whether or not they disclosed. Compared with women in the control group, women who received the intervention—both those who did and did not experience IPV—were 63% more likely than those in the control group to end a relationship because they perceived it to be unhealthy or unsafe. In this case, all women—not just those who were victims—benefited from receiving information about IPV.⁶⁰

PROVIDERS’ SUPPORT MAKES A DIFFERENCE, IMPROVES OUTCOMES

Patients may seek help for and find safety from IPV in stages or steps, and it may take them several months or even years to do so.^61–63 In this sense, then, IPV is an issue that is not likely to be “cured” or changed in a single medical visit. In addition, a single visit may not be associated with direct health and safety outcomes. However, a patient is more likely to make changes if she has supportive and informative interaction with a caring, nonjudgmental clinician who can increase her awareness of IPV and IPV resources and promote an improved sense of self-efficacy or perceived power.⁴⁰

For example, in a study in which health clinicians expressed concern about potential IPV health effects and offered support services such as counseling, 67% of women used one of those resources at least once.⁴⁰ In another study, women who talked to a health care provider about their abuse were almost four times more likely to use an IPV intervention (eg, advocacy, shelter, restraining order) than women who did not talk to their provider. Those who used an IPV intervention were 2.6 times more likely to leave their abusive relationship, and those who left reported improved physical health.⁶⁴

Thus, health care providers can have a positive effect by addressing this complex and difficult issue. The power and influence of a provider’s kindness, empathy, and support cannot be overestimated in their ability to improve the safety and well-being of women dealing with IPV.

Also known as “domestic violence” and “spouse abuse,” intimate partner violence (IPV) is now the term defined by the US Centers for Disease Control and Prevention to include physical violence, sexual violence, threats of physical or sexual violence, and psychological or emotional abuse by a current or former spouse, common-law spouse, nonmarital dating partner, or boyfriend or girlfriend of the same or opposite sex.¹ Although IPV is often hidden or kept secret by those affected, it is a highly prevalent issue, especially in women. Knowing how to broach the subject and provide appropriate support in a caring and nonjudgmental manner are the keys to helping a woman move forward in her readiness and ability to improve her situation.

See related patient information

ONE IN THREE WOMEN EXPERIENCES IPV IN HER LIFE

As clinicians, we have all seen patients who have been affected by IPV—even if we did not realize it at the time. Indeed, 36% of women in the United States (approximately 42.4 million) have experienced rape, physical violence, or stalking by an intimate partner in their lifetime, and 6% (approximately 7 million) have experienced these forms of IPV within the past 12 months.²

ASSOCIATION WITH MURDER

From 30% to 70% of women who are murdered are killed by a current or former intimate partner.^3,4 Of those killed by their partner, two-thirds had previously reported physical assault, and 83% had been threatened by the man who eventually killed them.⁴ In another study, 44% of IPV murder victims had presented to an emergency department within 2 years of their murder.⁵

PHYSICAL EFFECTS NOT ALWAYS APPARENT

Although 41% of women who experience IPV suffer physical injury from their attacks, only 28% of those who are injured seek medical care.⁶ Because injuries are often absent or no longer apparent when an IPV victim decides to get help, it is important to be aware of the clinical signs associated with IPV:

• Gastrointestinal disorders⁷
• Depression⁸
• Anxiety
• Chronic pain syndromes⁹
• Substance abuse
• Suicidal ideation.¹⁰

In women of childbearing age, IPV is associated with unintended pregnancy, sexually transmitted infections, condom non-use,^11,12 inconsistent condom use,¹³ and fear of talking about condom use.^11,12 Coerced sexual experiences (eg, sexual intercourse that was not wanted or consented to) are common, with 28% to 42% of college women reporting at least one such experience. In more than three quarters of women who have been sexually assaulted, the first experience occurred before age 25.^14,15

One-quarter of women ages 16 to 29 have experienced reproductive coercion, which includes birth control sabotage or pregnancy coercion by the active male partner.¹⁶ Among women reporting birth control sabotage, 79% had also been victims of physical or sexual IPV.¹⁶

The cost of providing health care to women experiencing IPV is 1.4 to 2.5 times higher than that of the nonabused population. Studies have shown that female victims of both physical and nonphysical (eg, emotional or verbal) IPV are more likely to use emergency, mental health, and outpatient health care services. The economic toll of IPV, including health care and costs from lost productivity and premature death, ranges from $2.3 to $8.3 billion per year.^17,18

ASK FEMALE PATIENTS ABOUT IPV

In the early 1990s, various medical organizations began issuing policy statements that endorsed screening for IPV.^19–22 Since 1992, the Joint Commission on Accreditation of Healthcare Organizations has required hospitals and clinics to provide assistance to those experiencing IPV.²³ Although the United States Preventive Services Task Force initially found insufficient evidence to support regular IPV screening in health care settings,^24–27 the group reversed its position in 2012 after a review of more recent studies. The group now recommends that clinicians address IPV with all women of childbearing age.²⁸

A Cochrane review found that IPV screening increased identification of IPV survivors.²⁹ Female participants in many studies wanted clinicians to ask routinely about violence and to provide information on community and legal resources.^30,31

How should we ask about IPV?

Although various sets of screening questions and tools are available, no one instrument is considered better than the others. However, women experiencing IPV have specific preferences regarding how they want clinicians to ask and talk about the topic. In one survey, women who had experienced IPV preferred that clinicians ask about it as part of the complete medical history, as long as it did not create “an atmosphere of interrogation.”³²

The style in which a clinician asks about IPV may make a difference as well. In focus groups, immigrant Latina and Asian women who had experienced IPV stated that clinicians could facilitate open communication by initiating the discussion and exhibiting compassionate and supportive behavior during the visit.³³ Being able to see the same clinician at each visit also enhanced clinician-patient communication.³³

In a study of IPV screening in emergency room settings, most clinicians asked about IPV in a perfunctory, direct manner—generally some variant of, “Are you a victim of domestic violence?” In this study, patient IPV disclosure occurred more often when clinicians used an open-ended approach such as, “Tell me what happened,” or when clinicians probed for possible IPV (eg, “What do you think may be causing some of this stress?”).³⁴

In a focus group, female IPV survivors described feeling stigmatized or invalidated when clinicians were condescending, judgmental, or dismissive.³⁵ Nonjudgmental and supportive communication decreased the women’s sense of isolation and led to positive outcomes such as increased awareness of IPV as a problem, decreased isolation, and feeling that the clinician cared.³⁵

When addressing IPV, clinicians should explain why they are asking about it because it allows the woman to understand the context of the inquiry and to feel more comfortable about disclosing IPV. If the query is a regular part of a general screening or history-taking, for example, they should frame the question to make that point apparent. For example, “Because we know that many women in the United States experience physical, sexual or emotional violence from their romantic partners, I like to ask all of my patients whether they have been hurt or have felt threatened or afraid in a current or past relationship.”

In situations in which clinicians are concerned about IPV with a particular patient, they should explicitly share their concerns and desire to help the patient. One IPV survivor offered this advice: “Just look at the patient like she is your friend. Call her by her name. For instance, say ‘Sally, is he hurting you? Are you having problems? If you need help, I have some [phone] numbers.’ Personalize the encounter.”

It is also important to address IPV in a manner that ensures the patient’s safety, confidentiality, and dignity. When having this type of sensitive conversation, the patient should ideally be clothed and alone—without others present, particularly her partner. Professional interpreters should be available to women who do not speak English. The clinician should maintain eye contact, smile to communicate friendliness, and use a supportive tone.³⁶

Just asking may be an intervention

Qualitative studies have suggested that just the act of asking about IPV in a nonjudgmental and compassionate manner is helpful to women experiencing IPV.^35,37 Doing so not only helps women recognize the abuse, but also begins to decrease their sense of isolation and increase their awareness of helpful resources. It also gives the patient a sense that the clinician cares about her situation.³⁵ As a result, experts have begun to recommend that health clinicians view asking about IPV not merely as a screening tool, but as a potentially therapeutic intervention in and of itself.^35,37,38

HOW TO HELP

What to do when a woman discloses IPV

Female survivors, advocates, and health care clinicians who care for abused women suggest responding to a positive disclosure of IPV by providing the following:

Validation. The IPV perpetrator will often attempt to justify the violence and abuse by shifting some of the blame or responsibility for the violence onto the victim. This “brainwashing” leads to self-blame and a diminished sense of self-worth. However, clinicians can help reverse this mindset by acknowledging the woman’s disclosure and emphasizing that she did not deserve the abuse or violence. An example of such a statement is, “I am so very sorry that you went through that with your partner. You definitely did not deserve that. No one should ever be hurt by or afraid of the people who are supposed to love them.” Providing validation helps women recognize that the violence was a problem they did not deserve.^38,39

Support. Women who have experienced IPV appreciate feeling supported and cared for by their health care clinician. Even if the patient is not ready to take any definitive action regarding her relationship or situation, knowing that her clinician and the health care setting are resources and sources of support is both comforting and empowering.^35,40 Clinicians can communicate this support by stating, “I want you to know that whatever happens and whatever you decide, we are here for you.”

Respect for autonomy. Women experiencing IPV best understand their own situation and its various complexities and so they know best what they can do, cannot do, or need to do. As such, clinicians must respect a woman’s autonomy and preserve her ability to express her own needs and desires and make her own decisions. Prescribing a plan of action or giving commands to IPV victims could further perpetuate their sense of disempowerment and lack of control over their life.

Information. Providing referral information or hotline numbers to community domestic violence programs is helpful. However, not all women feel safe or comfortable taking printed brochures or written information with them because their abusive partner may find it. Thus, clinicians should ask if the patient can take the information safely or offer to write the numbers down without labeling them if she is afraid. The National Domestic Violence hotline is a 24-hour toll-free resource that will help women locate and contact shelters and other support services in their own community. The number, 1-800-799-SAFE (7233), is easy to memorize and thus is an easy resource to pass along quickly and safely. Other national organizations such as Futures Without Violence (formerly known as the Family Violence Prevention Fund) and the National Coalition Against Violence also provide links to local resources (Table 1).

Safety planning. Discussing the need for a safety plan will help the patient prepare for future abusive episodes. Even women who report that they are no longer in an abusive relationship should be asked about their current safety needs and concerns because they often remain in contact with abusive partners even after a relationship has ended.

When discussing safety planning, clinicians should ask the woman if she is currently safe or if she needs shelter. If she intends to return to or is still in contact with her batterer, ask if she has a plan for what to do or how to escape if the violence occurs again. Advise the patient to:

• Hide money so that she can leave quickly
• Make copies of birth certificates, immunization records, Social Security Number, and other important documents and keep them hidden and accessible
• Make a spare car key
• Have a list of hotline numbers
• Develop a code with friends, family, and neighbors that will let them know she needs immediate help.

Studies show that discussing safety-promoting behaviors increases the number of them that are used by IPV victims.⁴¹ A detailed list that can be shared with patients is provided in the patient information page that accompanies this article.⁴² Examples of personalized safety plans are available from the National Center on Domestic and Sexual Violence at its website, www.ncdsv.org/images/NCDSV_DVSafetyPlan_updated2013.pdf.

Danger assessment. Several researchers have examined potential risk factors associated with increased risk of homicide.⁴³ Table 2 lists some of the characteristics associated with an increased risk of homicide in IPV situations.⁴² From this work, a danger assessment tool and scoring system has been developed. This tool and training on how to use it are available for free at www.dangerassessment.org. Although there are currently no outcome data on the benefits or risks of using this instrument, its objective is to increase women’s awareness of their danger level and individualize their safety counseling.

Proper documentation. Victim advocates and lawyers working on behalf of IPV victims emphasize that documentation by a medical provider can help a woman with her legal case. This documentation should be clear, legible, and as detailed as possible. These details should include a patient’s own words set off by quotation marks, a description or body map illustrating associated injuries or physical signs corroborating the violence, and a description of the patient’s demeanor or signs of emotion. Clinicians should avoid legal terms such as “alleges” or “alleged perpetrator” and should either define or avoid abbreviations that may be considered ambiguous in a legal proceeding (eg, clinicians should write out the words “domestic violence” or “intimate partner violence” rather than using “DV” or “IPV”).⁴⁴ Most states have passed laws that prevent insurance companies from discriminating against IPV victims; insurance companies can no longer deny women coverage for seeking care related to IPV.⁴⁵

A nonthreatening physical examination. Women who have experienced physical or sexual violence may feel anxious or experience added trauma during certain portions of the physical examination. Women who have been raped or otherwise sexually abused may have difficulty tolerating a pelvic examination, for example. Others who have been choked or grabbed by the neck may experience distress during palpation of the thyroid or cervical lymph nodes. The oropharyngeal examination may be challenging for women who have experienced forced oral sex or who may have had objects such as the barrel of a gun forced into their mouth. Asking women who have experienced IPV what aspects of the physical examination they may find difficult and how this could be made easier allows the patient and clinician to work together to develop strategies for or alternatives to necessary examinations or testing.

Before starting an examination, clinicians should explain what will happen and then ask the patient for her permission before moving on to the next step. Doing so creates a sense of control in an otherwise challenging and potentially traumatizing examination.

Disclosure of mandatory IPV reporting. Many states require health care providers to report any injuries caused by a weapon or criminal act to police or other official institutions.^45,46 Several of these states specify that this reporting should occur during an IPV evaluation.

Mandatory reporting of IPV to police is highly controversial.^47–49 Opponents of these laws argue that they do not benefit victims because they do not respect autonomy, they violate patient-clinician confidentiality, and they violate informed consent.⁴⁷ Female IPV victims indicate that they would be less likely to disclose IPV and seek help if they knew it had to be reported.^50–53 In a survey of California physicians, 59% stated that they might not comply with reporting laws if the patient objected.⁵⁴

In states with mandatory reporting laws, clinicians can advocate for their patients by disclosing whether IPV must be reported before beginning their examination. The Michigan Coalition Against Domestic Violence devised this sample statement:

“I do have to let you know that under state law, I am obligated to make a police report to (name police agency with jurisdiction over the facility), if I/we are treating someone for any injury sustained by means of violence (tailor this information to the specifics of your state law). So, if you would have any concerns about that, I would encourage you to speak with one of the domestic violence advocates/counselors at (DV agency), who are able to provide confidential services and help without being required to make a police report.”⁵⁵

The Compendium of State Statutes and Polices on Domestic Violence and Health Care by Futures Without Violence is an excellent reference that describes current state laws and policies regarding domestic violence and includes descriptions of the specific characteristics of each state’s mandatory reporting laws and their implications for health care providers. A copy can be downloaded from www.futureswithout-violence.org/content/features/detail/1584/.

What not to do

Clinicians should not ignore or minimize the extent of IPV, make excuses for the batterer, or blame the woman.^32,56,57 They also should not inadvertently blame or criticize the woman by asking her, “What did you do to deserve this?” or “Why don’t you just leave?”⁵⁷

While leaving a violent relationship is an obvious solution, many women experiencing IPV are either unwilling or unable to do so. In fact, leaving the batterer can be just as dangerous as staying. In a North Carolina study, half of all women killed by their partner had divorced or broken up with the partner immediately before the murder.⁴

What to do when a woman does not disclose IPV

Women who have experienced IPV often deny the violence to others out of fear. So a denial of violence, even in highly suspicious cases, can be expected. Abused patients often want help but are confused and afraid to ask for it.^58,59 Providing easy and anonymous access to IPV information and resources through posters, flyers, brochures, and booklets will allow any woman—regardless of disclosure—to obtain help.³⁶

In one IPV trial, all women in a family planning clinic who were in the intervention group were given information about IPV and how it can affect sexual and reproductive health, whether or not they disclosed. Compared with women in the control group, women who received the intervention—both those who did and did not experience IPV—were 63% more likely than those in the control group to end a relationship because they perceived it to be unhealthy or unsafe. In this case, all women—not just those who were victims—benefited from receiving information about IPV.⁶⁰

PROVIDERS’ SUPPORT MAKES A DIFFERENCE, IMPROVES OUTCOMES

Patients may seek help for and find safety from IPV in stages or steps, and it may take them several months or even years to do so.^61–63 In this sense, then, IPV is an issue that is not likely to be “cured” or changed in a single medical visit. In addition, a single visit may not be associated with direct health and safety outcomes. However, a patient is more likely to make changes if she has supportive and informative interaction with a caring, nonjudgmental clinician who can increase her awareness of IPV and IPV resources and promote an improved sense of self-efficacy or perceived power.⁴⁰

For example, in a study in which health clinicians expressed concern about potential IPV health effects and offered support services such as counseling, 67% of women used one of those resources at least once.⁴⁰ In another study, women who talked to a health care provider about their abuse were almost four times more likely to use an IPV intervention (eg, advocacy, shelter, restraining order) than women who did not talk to their provider. Those who used an IPV intervention were 2.6 times more likely to leave their abusive relationship, and those who left reported improved physical health.⁶⁴

Thus, health care providers can have a positive effect by addressing this complex and difficult issue. The power and influence of a provider’s kindness, empathy, and support cannot be overestimated in their ability to improve the safety and well-being of women dealing with IPV.

If you are being abused, making a safety plan now may help you when you have to act quickly in the future. The following ideas are ways that other women have planned for their safety. Some of these ideas may work for you. You may come up with additional ideas for yourself. You know your own situation better than anyone else, so plan what will work best for you.

• Hide money or put it somewhere safe so you can leave quickly.
• Make copies of birth certificates, immunization records, Social Security numbers, and other important documents to keep in safe locations away from home such as at work, the homes of trusted family members or friends, or hidden in convenient locations.
• Hide a spare car key or bus or subway pass that you can grab quickly.
• Keep a list of hotline numbers, or memorize the 1-800-799-SAFE National Domestic Violence Hotline number.
• Develop a code with friends, family, or neighbors to let them know when you need help in an emergency. If you have children, teach them a signal (like a code word) that means they should call the police or go for help. You may want to have a special code for neighbors (like putting on a particular light or opening a certain window) that means you want them to call the police.
• Plan your exit. Know which doors, windows, stairwells, elevators, or fire escapes you can use if you have to leave quickly. Practice using them so that they feel familiar to you.
• Know how to reach the police and your local women’s shelter.
• Every day, think about where you can go immediately if you have to leave. Is a neighbor home today? A relative? A friend?
• Remove weapons from your home if you can.
• Something to think about: When you cannot get away and your partner becomes violent, which room is the safest for you to get to? Is there a room that has a phone and a lock on the door? Can you stay out of rooms with easy weapons, such as the kitchen?
• Try not to leave without your children. But if you have to leave your children with the abuser, call the police immediately after you escape.

Adapted from Chang JC. Domestic violence. In: Bieber EJ, et al, editors. Clinical Gynecology. Philadelphia, PA; Elsevier, Inc; 2006:79–89.

This information is provided by your physician and the Cleveland Clinic Journal of Medicine. It is not designed to replace a physician’s medical assessment and judgment.

This page may be reproduced noncommercially to share with patients. Any other reproduction is subject to Cleveland Clinic Journal of Medicine approval. Bulk color reprints available by calling 216-444-2661.

For patient information on hundreds of health topics, see the Center for Consumer Health Information web site, www.clevelandclinic.org/health

If you are being abused, making a safety plan now may help you when you have to act quickly in the future. The following ideas are ways that other women have planned for their safety. Some of these ideas may work for you. You may come up with additional ideas for yourself. You know your own situation better than anyone else, so plan what will work best for you.

• Hide money or put it somewhere safe so you can leave quickly.
• Make copies of birth certificates, immunization records, Social Security numbers, and other important documents to keep in safe locations away from home such as at work, the homes of trusted family members or friends, or hidden in convenient locations.
• Hide a spare car key or bus or subway pass that you can grab quickly.
• Keep a list of hotline numbers, or memorize the 1-800-799-SAFE National Domestic Violence Hotline number.
• Develop a code with friends, family, or neighbors to let them know when you need help in an emergency. If you have children, teach them a signal (like a code word) that means they should call the police or go for help. You may want to have a special code for neighbors (like putting on a particular light or opening a certain window) that means you want them to call the police.
• Plan your exit. Know which doors, windows, stairwells, elevators, or fire escapes you can use if you have to leave quickly. Practice using them so that they feel familiar to you.
• Know how to reach the police and your local women’s shelter.
• Every day, think about where you can go immediately if you have to leave. Is a neighbor home today? A relative? A friend?
• Remove weapons from your home if you can.
• Something to think about: When you cannot get away and your partner becomes violent, which room is the safest for you to get to? Is there a room that has a phone and a lock on the door? Can you stay out of rooms with easy weapons, such as the kitchen?
• Try not to leave without your children. But if you have to leave your children with the abuser, call the police immediately after you escape.

Adapted from Chang JC. Domestic violence. In: Bieber EJ, et al, editors. Clinical Gynecology. Philadelphia, PA; Elsevier, Inc; 2006:79–89.

This information is provided by your physician and the Cleveland Clinic Journal of Medicine. It is not designed to replace a physician’s medical assessment and judgment.

This page may be reproduced noncommercially to share with patients. Any other reproduction is subject to Cleveland Clinic Journal of Medicine approval. Bulk color reprints available by calling 216-444-2661.

For patient information on hundreds of health topics, see the Center for Consumer Health Information web site, www.clevelandclinic.org/health

If you are being abused, making a safety plan now may help you when you have to act quickly in the future. The following ideas are ways that other women have planned for their safety. Some of these ideas may work for you. You may come up with additional ideas for yourself. You know your own situation better than anyone else, so plan what will work best for you.

• Hide money or put it somewhere safe so you can leave quickly.
• Make copies of birth certificates, immunization records, Social Security numbers, and other important documents to keep in safe locations away from home such as at work, the homes of trusted family members or friends, or hidden in convenient locations.
• Hide a spare car key or bus or subway pass that you can grab quickly.
• Keep a list of hotline numbers, or memorize the 1-800-799-SAFE National Domestic Violence Hotline number.
• Develop a code with friends, family, or neighbors to let them know when you need help in an emergency. If you have children, teach them a signal (like a code word) that means they should call the police or go for help. You may want to have a special code for neighbors (like putting on a particular light or opening a certain window) that means you want them to call the police.
• Plan your exit. Know which doors, windows, stairwells, elevators, or fire escapes you can use if you have to leave quickly. Practice using them so that they feel familiar to you.
• Know how to reach the police and your local women’s shelter.
• Every day, think about where you can go immediately if you have to leave. Is a neighbor home today? A relative? A friend?
• Remove weapons from your home if you can.
• Something to think about: When you cannot get away and your partner becomes violent, which room is the safest for you to get to? Is there a room that has a phone and a lock on the door? Can you stay out of rooms with easy weapons, such as the kitchen?
• Try not to leave without your children. But if you have to leave your children with the abuser, call the police immediately after you escape.

Adapted from Chang JC. Domestic violence. In: Bieber EJ, et al, editors. Clinical Gynecology. Philadelphia, PA; Elsevier, Inc; 2006:79–89.

This information is provided by your physician and the Cleveland Clinic Journal of Medicine. It is not designed to replace a physician’s medical assessment and judgment.

This page may be reproduced noncommercially to share with patients. Any other reproduction is subject to Cleveland Clinic Journal of Medicine approval. Bulk color reprints available by calling 216-444-2661.

For patient information on hundreds of health topics, see the Center for Consumer Health Information web site, www.clevelandclinic.org/health

Frail older adults deserve guidelines that take frailty into account while assessing the potential benefit and risks of treatment.

Specifically, our group—the Dalhousie Academic Detailing Service (ADS) and the Palliative and Therapeutic Harmonization (PATH) program—recommends that physicians strive to achieve more liberal treatment targets for elderly frail patients who have high blood pressure,¹ as evidence does not support an aggressive approach in the frail elderly and the potential exists for harm.

This article reviews the evidence and reasoning that were used to develop and promote a guideline for drug treatment of hypertension in frail older adults. Our recommendations differ from other guidelines in that they focus as much on stopping or decreasing therapy as on starting or increasing it.

FRAILTY INCREASES THE RISK OF ADVERSE EFFECTS

The word frail, applied to older adults, describes those who have complex medical illnesses severe enough to compromise their ability to live independently.² Many have multiple coexisting medical problems for which they take numerous drugs, in addition to dementia, impaired mobility, compromised functional ability, or a history of falling.

Frailty denotes vulnerability; it increases the risk of adverse effects from medical and surgical procedures,³ complicates drug therapy,⁴ prolongs hospital length of stay,⁵ leads to functional and cognitive decline,⁶ increases the risk of institutionalization,⁷ and reduces life expectancy⁸—all of which affect the benefit and harm of medical treatments.

Guidelines for treating hypertension^9–11 now acknowledge that little evidence exists to support starting treatment for systolic blood pressure between 140 and 160 mm Hg or aiming for a target of less than 140 mm Hg for “very old” adults, commonly defined as over the age of 80. New guidelines loosen the treatment targets for the very old, but they do not specify targets for the frail and do not describe how to recognize or measure frailty.

RECOGNIZING AND MEASURING FRAILTY

A number of tools are available to recognize and measure frailty.¹²

The Fried frailty assessment¹³ has five items:

• Unintentional weight loss
• Self-reported exhaustion
• Weakness in grip
• Slow walking speed
• Low physical activity and energy expenditure.

People are deemed frail if they have three or more of these five. However, experts disagree about whether this system is too sensitive¹⁴ or not sensitive enough.^15,16

The FRAIL questionnaire¹⁷ also has five items:

• Fatigue
• Resistance (inability to climb stairs)
• Ambulation (inability to walk 1 city block)
• Illness (more than 5 major illnesses)
• Weight loss.

People are deemed frail if they have at least three of these five items, and “prefrail” if they have two.

These and other tools are limited by being dichotomous: they classify people as being either frail or not frail^18–20 but do not define the spectrum of frailty.

Other frailty assessments such as the Frailty Index²¹ identify frailty based on the number of accumulated health deficits but take a long time to complete, making them difficult to use in busy clinical settings.^22–24

The Clinical Frailty Scale⁷ is a validated scale that categorizes frailty based on physical and functional indicators of health, such as cognition, function, and mobility, with scores that range from 1 (very fit) to 9 (terminally ill).^7,12

The Frailty Assessment for Care-planning Tool (FACT) uses scaling compatible with the Clinical Frailty Scale but has been developed for use as a practical and interpretable frailty screening tool for nonexperts (Table 1). The FACT assesses cognition, mobility, function, and the social situation, using a combination of caregiver report and objective measures. To assess cognition, a health care professional uses items from the Mini-Cog²⁵ (ie, the ability to draw an analog clock face and then recall three unrelated items following the clock-drawing test) and the memory axis of the Brief Cognitive Rating Scale²⁶ (ie, the ability to recall current events, the current US president, and the names of children or spouse). Mobility, function, and social circumstance scores are assigned according to the caregiver report of the patient’s baseline status.

The FACT can be completed in busy clinical settings. Once a caregiver is identified, it takes about 5 minutes to complete.

Our guideline^27–31 is intended for those with a score of 7 or more on the Clinical Frailty Scale or FACT,^7,12 a score we chose because it describes people who are severely frail with shortened life expectancy.⁸ At this level, people need help with all instrumental activities of daily living (eg, handling finances, medication management, household chores, and shopping) as well as with basic activities of daily living such as bathing or dressing.

REVIEWING THE LIMITED EVIDENCE

We found no studies that addressed the risks and benefits of treating hypertension in frail older adults; therefore, we concentrated on studies that enrolled individuals who were chronologically old but not frail. We reviewed prominent guidelines,^9–11,32,33 the evidence base for these guidelines,^34–44 and Cochrane reviews.^45,46 A detailed description of the evidence used to build our recommendation can be found online.³¹

When we deliberated on treatment targets, we reviewed evidence from two types of randomized controlled trials⁴⁷:

Drug treatment trials randomize patients to different treatments, such as placebo versus a drug or one drug compared with another drug. Patients in different treatment groups may achieve different blood pressures and clinical outcomes, and this information is then used to define optimal targets. However, it may be difficult to determine if the benefit came from lowering blood pressure or from some other effect of the drug, which can be independent of blood pressure lowering.

Treat-to-target trials randomize patients to different blood pressure goals, but the groups are treated with the same or similar drugs. Therefore, any identified benefit can be attributed to the differences in blood pressure rather than the medications used. Compared with a drug treatment trial, this type of trial provides stronger evidence about optimal targets.

We also considered the characteristics of frailty, the dilemma of polypharmacy, and the relevance of the available scientific evidence to those who are frail.

Drug treatment trials

A Cochrane review⁴⁵ of 15 studies with approximately 24,000 elderly participants found that treating hypertension decreased the rates of cardiovascular morbidity and mortality as well as fatal and nonfatal stroke in the “elderly” (defined as age ≥ 60) and “very elderly” (age ≥ 80). However, in the very elderly, all-cause mortality rates were not statistically significantly different with treatment compared with placebo. The mean duration of treatment was 4.5 years in the elderly and 2.2 years in the very elderly (Table 2). Of importance, all the trials enrolled only those individuals whose systolic blood pressure was at least 160 mm Hg at baseline.

None of the studies were treat-to-target trials—patients were assigned either active medication or placebo. Thus, these trials provide evidence of benefit for treating hypertension in the elderly and very elderly but do not identify the optimal target. All of the drug treatment trials showed benefit, but none achieved a systolic pressure lower than 140 mm Hg with active treatment (Table 3). Therefore, these studies do not support a systolic target of less than 140 mm Hg in the elderly.

Treat-to-target trials: JATOS and VALISH

The Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients (JATOS)⁴² and the Valsartan in Elderly Isolated Systolic Hypertension (VALISH) study⁴³ each enrolled more than 3,000 people age 65 or older (mean age approximately 75). Patients were randomized to either a strict systolic target of less than 140 mm Hg or a higher (more permissive) target of 140 to 160 mm Hg in JATOS and 140 to 149 mm Hg in VALISH.

In both trials, the group with strict targets achieved a systolic pressure of approximately 136 mm Hg, while the group with higher blood pressure targets achieved a systolic pressure of 146 mm Hg in JATOS and 142 mm Hg in VALISH. Despite these differences, there was no statistically significant difference in the primary outcome.

Thus, treat-to-target studies also fail to support a systolic target of less than 140 mm Hg in the elderly, although it is important to recognize the limitations of the studies. Approximately 15% of the participants had cardiovascular disease, so the applicability of the findings to patients with target-organ damage is uncertain. In addition, there were fewer efficacy outcome events than expected, which suggests that the studies were underpowered.

When to start drug treatment

In each of the drug treatment and treat-to-target trials, the inclusion criterion for study entry was a systolic blood pressure above 160 mm Hg, with a mean blood pressure at entry into the drug treatment trials of 182/95 mm Hg.⁴⁶ Thus, data support starting treatment if the systolic blood pressure is above 160 mm Hg, but not lower.

Notably, in all but one study,⁴⁶ at least two-thirds of the participants took no more than two antihypertensive medications. Since adverse events become more common as the number of medications increases, the benefit of adding a third drug to lower blood pressure is uncertain.

Evidence in the ‘very elderly’: HYVET

With the exception of the Hypertension in the Very Elderly Trial (HYVET),⁴⁴ the mean age of elderly patients in the reported studies was between 67 and 76.

HYVET patients were age 80 and older (mean age 84) and were randomized to receive either indapamide (with or without perindopril) or placebo. The trial was stopped early at 2 years because the mortality rate was lower in the treatment group (10.1%) than in the placebo group (12.3%) (number needed to treat 46, 95% confidence interval 24–637, P = .02). There was no significant difference in the primary outcome of fatal and nonfatal stroke.

Notably, trials that are stopped early may overestimate treatment benefit.⁴⁸

Evidence in frail older adults

While the above studies provide some information about managing hypertension in the elderly, the participants were generally healthy. HYVET⁴⁴ specifically excluded those with a standing systolic blood pressure of less than 140 mm Hg and enrolled few patients with orthostasis (7.9% in the placebo group and 8.8% in the treatment group), a condition commonly associated with frailty. As such, these studies may be less relevant to the frail elderly, who are at higher risk of adverse drug events and have competing risks for morbidity and mortality.

Observational studies, in fact, raise questions about whether tight blood pressure control improves clinical outcomes for the very elderly. In the Leiden 85-plus study, lower systolic blood pressure was associated with lower cognitive scores, worse functional ability,^49,50 and a higher mortality rate⁵¹ compared with higher systolic pressure, although it is uncertain whether these outcomes were indicative of underlying disease that could result in lower blood pressure or an effect of blood pressure-lowering.

The National Health and Nutrition Examination Survey⁵² found an association between blood pressure and mortality rate that varied by walking speed. For slower walkers (based on the 6-minute walk test), higher systolic pressures were not associated with a higher risk of death, suggesting that when older adults are frail (as indicated by their slow walking speed) they are less likely to benefit from aggressive treatment of hypertension.

People at high risk because of stroke

Because the evidence is limited, it is even more difficult to judge whether lowering blood pressure below 140 mm Hg is beneficial for frail patients who have a history of stroke, compared with the possibility that medications will cause adverse effects such as weakness, orthostasis, and falls. When reviewing the evidence to answer this question, we especially looked at outcomes that affect quality of life, such as nonfatal stroke leading to disability. In contrast, because the frail elderly have competing causes of mortality, we could not assume that a mortality benefit shown in nonfrail populations could be applied to frail populations.

The PROGRESS trial (Perindopril Protection Against Recurrent Stroke Study)⁵³ was in patients with a history of stroke or transient ischemic attack and a mean age of 64, who were treated with either perindopril (with or without indapamide) or placebo.

At almost 4 years, the rate of disabling stroke was 2.7% in the treatment group and 4.3% in the placebo group, a relative risk reduction of 38% and an absolute risk reduction of 1.64% (number needed to treat 61, 95% confidence interval 39–139). The relative risk reduction for all strokes (fatal and nonfatal) was similar across a range of baseline systolic pressures, but the absolute risk reduction was greater in the prespecified subgroup that had hypertension at baseline (mean blood pressure 159/94 mm Hg) than in the normotensive subgroup (mean blood pressure 136/79 mm Hg), suggesting that treatment is most beneficial for those with higher systolic blood pressures. Also, the benefit was only demonstrated in the subgroup that received two antihypertensive medications; those who received perindopril alone showed no benefit.

This study involved relatively young patients in relatively good health except for their strokes. The extent to which the results can be extrapolated to older, frail adults is uncertain because of the time needed to achieve benefit and because of the added vulnerability of frailty, which could make treatment with two antihypertensive medications riskier.

PRoFESS (Prevention Regimen for Effectively Avoiding Second Strokes),⁵⁴ another study in patients with previous stroke (mean age 66) showed no benefit over 2.5 years in the primary outcome of stroke using telmesartan 80 mg daily compared with placebo. This result is concordant with that of PROGRESS,⁵³ in which patients who took only one medication did not show a significant decrease in the rate of stroke.

A possible reason for the lack of benefit from monotherapy was that the differences in blood pressure between the placebo group and the treatment group on monotherapy were small in both studies (3.8/2.0 mm Hg in PRoFESS, 5/3 mm Hg in PROGRESS). In contrast, patients on dual therapy in PROGRESS decreased their blood pressure by 12/5 mm Hg compared with placebo.

CURRENT HYPERTENSION GUIDELINES

Current guidelines make reference to the elderly, but we found none that made specific recommendations for the frail elderly.

JNC 8

In December 2013, members of the Eighth Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8) released new recommendations.³² One significant revision was to support higher blood pressure targets for older adults (age 60 and older). Whereas JNC 7 stated that lowering blood pressure below 140/90 mm Hg reduced cardiovascular complications,³³ JNC 8 now acknowledges that there is no strong evidence to support blood pressure targets below 150/90 mm Hg for hypertensive persons without kidney disease or diabetes age 60 and older. Thus, in the general population age 60 and older, JNC 8 recommends starting antihypertensive treatment when blood pressure is 150/90 mm Hg or higher, and treating to a goal blood pressure of less than 150/90 mm Hg. JNC 8 makes no recommendation about how to adjust blood pressure targets for frailty or how to measure blood pressure.

American College of Cardiology and American Heart Association

In 2011, the American College of Cardiology and American Heart Association published a consensus document on the management of hypertension in the elderly.⁹

They acknowledged that the generally recommended blood pressure goal of lower than 140/90 mm Hg in uncomplicated elderly patients is based on expert opinion rather than on data from randomized controlled trials, but nevertheless recommended a target systolic pressure lower than 140 mm Hg for older adults, except for octogenarians.

For those over age 80, systolic levels of 140 to 145 mm Hg can be acceptable if tolerated and if the patient does not experience orthostasis when standing. Systolic pressure lower than 130 mm Hg and diastolic pressures lower than 65 mm Hg should be avoided in this age group.

The document acknowledges that systolic pressure may have to remain above 150 mm Hg if there is no response to four “well-selected drugs” or if there are unacceptable side effects. In these cases, the lowest “safely achieved” systolic blood pressure should be the goal.

Canadian Hypertension Education Program

The 2014 Canadian Hypertension Education Program (CHEP) report makes several recommendations for the “very elderly,” a group they define as over the age of 80. The CHEP website and resources include the following recommendations¹⁰:

• For the very elderly without diabetes or target-organ damage, drug therapy should be initiated when systolic blood pressure is higher than 160 mm Hg to reach a systolic blood pressure target lower than 150 mm Hg. This is a grade C level recommendation, indicating that it is based on low-quality trials, unvalidated surrogate outcomes, or results from nonrandomized observational studies.
• For the very elderly with macrovascular target-organ damage, antihypertensive therapy should be considered if systolic blood pressure readings average 140 mm Hg or higher (grade D for 140 to 160 mm Hg; grade A for higher than 160 mm Hg), although caution should be exercised in elderly patients who are frail. (Grade D recommendations are the weakest, as they are based on low-powered, imprecise studies or expert opinion, whereas grade A recommendations are based on the strongest evidence from high-quality randomized clinical trials.)
• Decisions regarding initiating and intensifying pharmacotherapy in the very elderly should be based on an individualized risk-benefit analysis.

The European Society of Hypertension and European Society of Cardiology

The 2013 guidelines from the European Society of Hypertension and the European Society of Cardiology¹¹ recommend that for elderly patients under age 80, antihypertensive treatment may be considered at systolic values higher than 140 mm Hg and aimed at values lower than 140 mm Hg if the patient is fit and treatment is well tolerated.

For those over age 80 with an initial systolic pressure of 160 mm Hg or higher, the guidelines recommend lowering systolic pressure to between 150 and 140 mm Hg, provided the patient is in good physical and mental condition. In frail elderly patients, they recommend leaving decisions on antihypertensive therapy to the treating physician, based on monitoring of the clinical effects of treatment.¹¹

The ADS/PATH guidelines

When finalizing our recommendations,¹ we considered the characteristics of frailty and the following key points from the evidence:

• Although evidence from drug treatment trials indicates that there is benefit in treating healthy older adults who have hypertension, the benefit of treating frail older adults is unknown.
• Major trials enrolled elderly patients only if they had systolic blood pressures of at least 160 mm Hg. Therefore, evidence supports initiating pharmacotherapy at a systolic pressure of 160 mm Hg or higher.
• No evidence from randomized controlled trials supports a systolic target lower than 140 mm Hg in the elderly, and there is some evidence that such a target does not benefit.
• The benefit of adding a third medication to lower blood pressure has not been studied.
• Frailty makes the potential benefits of strict blood pressure targets even less certain and increases the possibility of harm from adverse drug events.
• The only study of very old adults, HYVET,⁴⁴ enrolled relatively healthy older adults and few with orthostasis, while excluding those with a standing systolic blood pressure lower than 140 mm Hg.

OUR RECOMMENDATIONS

Based on the above, we advise against unnecessarily strict targets and recommend stopping antihypertensive medications that are used for the sole purpose of keeping the systolic blood pressure below 140 mm Hg. Our guidelines are unique in that they focus equally on when to stop and when to start medications. We concluded that without evidence of definitive benefit, “less is more” with frailty.⁵⁵ We believe that if physicians and health professionals understand the limitations of the evidence, they can be more confident in stopping medications that lower blood pressure to an unnecessarily low level.

We recommend the following (Table 4):

Before treating

• Carefully review the risks and the potential but unproven benefits of treatment.
• To avoid overtreatment, treatment decisions should be based on blood pressure measurements in the seated (not supine) position, while also considering the presence of orthostasis.
• To evaluate orthostasis, measure blood pressure in the supine position, then immediately on standing, and again after 2 minutes. Ask the patient if he or she feels light-headed or dizzy when standing.

Stop treatment

• If the seated systolic blood pressure is less than 140 mm Hg, medications can be tapered and discontinued to achieve the targets described below.
• Before discontinuation, consider whether the medications are treating additional conditions such as rate control for atrial fibrillation or symptomatic management of heart failure.
• It is uncertain whether to discontinue treatment when there is a history of stroke. Consider that treatment with two medications resulted in an absolute risk reduction for disabling stroke of 1.64% over approximately 4 years for adults with previous stroke and a mean age of 64,⁵⁷ an effect that may be more prominent at higher systolic pressures.

Start treatment

• Consider starting treatment when systolic pressure is 160 mm Hg or higher.
• Aim for a seated systolic pressure between 140 and 160 mm Hg if there are no adverse effects from treatment that affect quality of life.
• If there is symptomatic orthostasis or if standing systolic pressure is lower than 140 mm Hg, the target seated systolic pressure can be adjusted upwards.
• In the severely frail nearing the end of life, a target systolic pressure of 160 to 190 mm Hg is reasonable.
• The blood pressure target is the same in people with diabetes.
• In general, use no more than two medications.

Dissemination and implementation

The ADS/PATH guideline is intended for use by physicians and other health professionals (eg, pharmacists and nurses) who care for frail older adults or who work in long-term care facilities. Since creating our guideline, we have disseminated it to physicians, pharmacists, and other health professionals through academic detailing, large conferences, and interactive webinars.

While we do not have objective evidence of practice change, our evaluation data found that 34% of 403 family physicians who received academic detailing indicated that the guideline would change their practice, while 36% stated that the guideline confirmed their practice, an indication that family physicians are sensitive to the needs of the frail elderly.

Because health professionals may be wary of stopping medications and not meeting recommended targets, there may be barriers to adopting this guideline. However, our experience with the PATH program indicates that these barriers can be overcome using effective communication strategies between health professionals and consumers.

AN APPROACH APPROPRIATE TO FRAILTY

There is no direct evidence for systolic blood pressure targets in the frail elderly, so we applied evidence from the nonfrail elderly. Our recommendations differ somewhat from those of other groups, which recommend targets below 140 to 150 mm Hg for older adults, although some do advise caution in the elderly for whom a substantial fall in blood pressure might be poorly tolerated. Despite these messages, we believe that clearer guidance is needed to direct health practitioners toward models that acknowledge that frail patients are in a precarious balance of health and may be harmed by treatments that strive to lower blood pressure to unproven targets. For this reason, our guideline clearly indicates when to decrease or stop drug treatment.

After physicians and health professionals examine the evidence and more fully understand the benefits and harms of treating frail older adults, we are confident that they will be more comfortable stopping medications that lower blood pressure to an unnecessarily low level and instead use an approach that is more appropriate to frailty. We hope clinicians can use this guideline with the same enthusiasm applied to other guidelines, and we welcome discussion.

Acknowledgments: We would like to thank and acknowledge Tanya MacLeod and Kathryn Yuill for their review of and advice about the manuscript.

Frail older adults deserve guidelines that take frailty into account while assessing the potential benefit and risks of treatment.

Specifically, our group—the Dalhousie Academic Detailing Service (ADS) and the Palliative and Therapeutic Harmonization (PATH) program—recommends that physicians strive to achieve more liberal treatment targets for elderly frail patients who have high blood pressure,¹ as evidence does not support an aggressive approach in the frail elderly and the potential exists for harm.

This article reviews the evidence and reasoning that were used to develop and promote a guideline for drug treatment of hypertension in frail older adults. Our recommendations differ from other guidelines in that they focus as much on stopping or decreasing therapy as on starting or increasing it.

FRAILTY INCREASES THE RISK OF ADVERSE EFFECTS

The word frail, applied to older adults, describes those who have complex medical illnesses severe enough to compromise their ability to live independently.² Many have multiple coexisting medical problems for which they take numerous drugs, in addition to dementia, impaired mobility, compromised functional ability, or a history of falling.

Frailty denotes vulnerability; it increases the risk of adverse effects from medical and surgical procedures,³ complicates drug therapy,⁴ prolongs hospital length of stay,⁵ leads to functional and cognitive decline,⁶ increases the risk of institutionalization,⁷ and reduces life expectancy⁸—all of which affect the benefit and harm of medical treatments.

Guidelines for treating hypertension^9–11 now acknowledge that little evidence exists to support starting treatment for systolic blood pressure between 140 and 160 mm Hg or aiming for a target of less than 140 mm Hg for “very old” adults, commonly defined as over the age of 80. New guidelines loosen the treatment targets for the very old, but they do not specify targets for the frail and do not describe how to recognize or measure frailty.

RECOGNIZING AND MEASURING FRAILTY

A number of tools are available to recognize and measure frailty.¹²

The Fried frailty assessment¹³ has five items:

• Unintentional weight loss
• Self-reported exhaustion
• Weakness in grip
• Slow walking speed
• Low physical activity and energy expenditure.

People are deemed frail if they have three or more of these five. However, experts disagree about whether this system is too sensitive¹⁴ or not sensitive enough.^15,16

The FRAIL questionnaire¹⁷ also has five items:

• Fatigue
• Resistance (inability to climb stairs)
• Ambulation (inability to walk 1 city block)
• Illness (more than 5 major illnesses)
• Weight loss.

People are deemed frail if they have at least three of these five items, and “prefrail” if they have two.

These and other tools are limited by being dichotomous: they classify people as being either frail or not frail^18–20 but do not define the spectrum of frailty.

Other frailty assessments such as the Frailty Index²¹ identify frailty based on the number of accumulated health deficits but take a long time to complete, making them difficult to use in busy clinical settings.^22–24

The Clinical Frailty Scale⁷ is a validated scale that categorizes frailty based on physical and functional indicators of health, such as cognition, function, and mobility, with scores that range from 1 (very fit) to 9 (terminally ill).^7,12

The Frailty Assessment for Care-planning Tool (FACT) uses scaling compatible with the Clinical Frailty Scale but has been developed for use as a practical and interpretable frailty screening tool for nonexperts (Table 1). The FACT assesses cognition, mobility, function, and the social situation, using a combination of caregiver report and objective measures. To assess cognition, a health care professional uses items from the Mini-Cog²⁵ (ie, the ability to draw an analog clock face and then recall three unrelated items following the clock-drawing test) and the memory axis of the Brief Cognitive Rating Scale²⁶ (ie, the ability to recall current events, the current US president, and the names of children or spouse). Mobility, function, and social circumstance scores are assigned according to the caregiver report of the patient’s baseline status.

The FACT can be completed in busy clinical settings. Once a caregiver is identified, it takes about 5 minutes to complete.

Our guideline^27–31 is intended for those with a score of 7 or more on the Clinical Frailty Scale or FACT,^7,12 a score we chose because it describes people who are severely frail with shortened life expectancy.⁸ At this level, people need help with all instrumental activities of daily living (eg, handling finances, medication management, household chores, and shopping) as well as with basic activities of daily living such as bathing or dressing.

REVIEWING THE LIMITED EVIDENCE

We found no studies that addressed the risks and benefits of treating hypertension in frail older adults; therefore, we concentrated on studies that enrolled individuals who were chronologically old but not frail. We reviewed prominent guidelines,^9–11,32,33 the evidence base for these guidelines,^34–44 and Cochrane reviews.^45,46 A detailed description of the evidence used to build our recommendation can be found online.³¹

When we deliberated on treatment targets, we reviewed evidence from two types of randomized controlled trials⁴⁷:

Drug treatment trials randomize patients to different treatments, such as placebo versus a drug or one drug compared with another drug. Patients in different treatment groups may achieve different blood pressures and clinical outcomes, and this information is then used to define optimal targets. However, it may be difficult to determine if the benefit came from lowering blood pressure or from some other effect of the drug, which can be independent of blood pressure lowering.

Treat-to-target trials randomize patients to different blood pressure goals, but the groups are treated with the same or similar drugs. Therefore, any identified benefit can be attributed to the differences in blood pressure rather than the medications used. Compared with a drug treatment trial, this type of trial provides stronger evidence about optimal targets.

We also considered the characteristics of frailty, the dilemma of polypharmacy, and the relevance of the available scientific evidence to those who are frail.

Drug treatment trials

A Cochrane review⁴⁵ of 15 studies with approximately 24,000 elderly participants found that treating hypertension decreased the rates of cardiovascular morbidity and mortality as well as fatal and nonfatal stroke in the “elderly” (defined as age ≥ 60) and “very elderly” (age ≥ 80). However, in the very elderly, all-cause mortality rates were not statistically significantly different with treatment compared with placebo. The mean duration of treatment was 4.5 years in the elderly and 2.2 years in the very elderly (Table 2). Of importance, all the trials enrolled only those individuals whose systolic blood pressure was at least 160 mm Hg at baseline.

None of the studies were treat-to-target trials—patients were assigned either active medication or placebo. Thus, these trials provide evidence of benefit for treating hypertension in the elderly and very elderly but do not identify the optimal target. All of the drug treatment trials showed benefit, but none achieved a systolic pressure lower than 140 mm Hg with active treatment (Table 3). Therefore, these studies do not support a systolic target of less than 140 mm Hg in the elderly.

Treat-to-target trials: JATOS and VALISH

The Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients (JATOS)⁴² and the Valsartan in Elderly Isolated Systolic Hypertension (VALISH) study⁴³ each enrolled more than 3,000 people age 65 or older (mean age approximately 75). Patients were randomized to either a strict systolic target of less than 140 mm Hg or a higher (more permissive) target of 140 to 160 mm Hg in JATOS and 140 to 149 mm Hg in VALISH.

In both trials, the group with strict targets achieved a systolic pressure of approximately 136 mm Hg, while the group with higher blood pressure targets achieved a systolic pressure of 146 mm Hg in JATOS and 142 mm Hg in VALISH. Despite these differences, there was no statistically significant difference in the primary outcome.

Thus, treat-to-target studies also fail to support a systolic target of less than 140 mm Hg in the elderly, although it is important to recognize the limitations of the studies. Approximately 15% of the participants had cardiovascular disease, so the applicability of the findings to patients with target-organ damage is uncertain. In addition, there were fewer efficacy outcome events than expected, which suggests that the studies were underpowered.

When to start drug treatment

In each of the drug treatment and treat-to-target trials, the inclusion criterion for study entry was a systolic blood pressure above 160 mm Hg, with a mean blood pressure at entry into the drug treatment trials of 182/95 mm Hg.⁴⁶ Thus, data support starting treatment if the systolic blood pressure is above 160 mm Hg, but not lower.

Notably, in all but one study,⁴⁶ at least two-thirds of the participants took no more than two antihypertensive medications. Since adverse events become more common as the number of medications increases, the benefit of adding a third drug to lower blood pressure is uncertain.

Evidence in the ‘very elderly’: HYVET

With the exception of the Hypertension in the Very Elderly Trial (HYVET),⁴⁴ the mean age of elderly patients in the reported studies was between 67 and 76.

HYVET patients were age 80 and older (mean age 84) and were randomized to receive either indapamide (with or without perindopril) or placebo. The trial was stopped early at 2 years because the mortality rate was lower in the treatment group (10.1%) than in the placebo group (12.3%) (number needed to treat 46, 95% confidence interval 24–637, P = .02). There was no significant difference in the primary outcome of fatal and nonfatal stroke.

Notably, trials that are stopped early may overestimate treatment benefit.⁴⁸

Evidence in frail older adults

While the above studies provide some information about managing hypertension in the elderly, the participants were generally healthy. HYVET⁴⁴ specifically excluded those with a standing systolic blood pressure of less than 140 mm Hg and enrolled few patients with orthostasis (7.9% in the placebo group and 8.8% in the treatment group), a condition commonly associated with frailty. As such, these studies may be less relevant to the frail elderly, who are at higher risk of adverse drug events and have competing risks for morbidity and mortality.

Observational studies, in fact, raise questions about whether tight blood pressure control improves clinical outcomes for the very elderly. In the Leiden 85-plus study, lower systolic blood pressure was associated with lower cognitive scores, worse functional ability,^49,50 and a higher mortality rate⁵¹ compared with higher systolic pressure, although it is uncertain whether these outcomes were indicative of underlying disease that could result in lower blood pressure or an effect of blood pressure-lowering.

The National Health and Nutrition Examination Survey⁵² found an association between blood pressure and mortality rate that varied by walking speed. For slower walkers (based on the 6-minute walk test), higher systolic pressures were not associated with a higher risk of death, suggesting that when older adults are frail (as indicated by their slow walking speed) they are less likely to benefit from aggressive treatment of hypertension.

People at high risk because of stroke

Because the evidence is limited, it is even more difficult to judge whether lowering blood pressure below 140 mm Hg is beneficial for frail patients who have a history of stroke, compared with the possibility that medications will cause adverse effects such as weakness, orthostasis, and falls. When reviewing the evidence to answer this question, we especially looked at outcomes that affect quality of life, such as nonfatal stroke leading to disability. In contrast, because the frail elderly have competing causes of mortality, we could not assume that a mortality benefit shown in nonfrail populations could be applied to frail populations.

The PROGRESS trial (Perindopril Protection Against Recurrent Stroke Study)⁵³ was in patients with a history of stroke or transient ischemic attack and a mean age of 64, who were treated with either perindopril (with or without indapamide) or placebo.

At almost 4 years, the rate of disabling stroke was 2.7% in the treatment group and 4.3% in the placebo group, a relative risk reduction of 38% and an absolute risk reduction of 1.64% (number needed to treat 61, 95% confidence interval 39–139). The relative risk reduction for all strokes (fatal and nonfatal) was similar across a range of baseline systolic pressures, but the absolute risk reduction was greater in the prespecified subgroup that had hypertension at baseline (mean blood pressure 159/94 mm Hg) than in the normotensive subgroup (mean blood pressure 136/79 mm Hg), suggesting that treatment is most beneficial for those with higher systolic blood pressures. Also, the benefit was only demonstrated in the subgroup that received two antihypertensive medications; those who received perindopril alone showed no benefit.

This study involved relatively young patients in relatively good health except for their strokes. The extent to which the results can be extrapolated to older, frail adults is uncertain because of the time needed to achieve benefit and because of the added vulnerability of frailty, which could make treatment with two antihypertensive medications riskier.

PRoFESS (Prevention Regimen for Effectively Avoiding Second Strokes),⁵⁴ another study in patients with previous stroke (mean age 66) showed no benefit over 2.5 years in the primary outcome of stroke using telmesartan 80 mg daily compared with placebo. This result is concordant with that of PROGRESS,⁵³ in which patients who took only one medication did not show a significant decrease in the rate of stroke.

A possible reason for the lack of benefit from monotherapy was that the differences in blood pressure between the placebo group and the treatment group on monotherapy were small in both studies (3.8/2.0 mm Hg in PRoFESS, 5/3 mm Hg in PROGRESS). In contrast, patients on dual therapy in PROGRESS decreased their blood pressure by 12/5 mm Hg compared with placebo.

CURRENT HYPERTENSION GUIDELINES

Current guidelines make reference to the elderly, but we found none that made specific recommendations for the frail elderly.

JNC 8

In December 2013, members of the Eighth Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8) released new recommendations.³² One significant revision was to support higher blood pressure targets for older adults (age 60 and older). Whereas JNC 7 stated that lowering blood pressure below 140/90 mm Hg reduced cardiovascular complications,³³ JNC 8 now acknowledges that there is no strong evidence to support blood pressure targets below 150/90 mm Hg for hypertensive persons without kidney disease or diabetes age 60 and older. Thus, in the general population age 60 and older, JNC 8 recommends starting antihypertensive treatment when blood pressure is 150/90 mm Hg or higher, and treating to a goal blood pressure of less than 150/90 mm Hg. JNC 8 makes no recommendation about how to adjust blood pressure targets for frailty or how to measure blood pressure.

American College of Cardiology and American Heart Association

In 2011, the American College of Cardiology and American Heart Association published a consensus document on the management of hypertension in the elderly.⁹

They acknowledged that the generally recommended blood pressure goal of lower than 140/90 mm Hg in uncomplicated elderly patients is based on expert opinion rather than on data from randomized controlled trials, but nevertheless recommended a target systolic pressure lower than 140 mm Hg for older adults, except for octogenarians.

For those over age 80, systolic levels of 140 to 145 mm Hg can be acceptable if tolerated and if the patient does not experience orthostasis when standing. Systolic pressure lower than 130 mm Hg and diastolic pressures lower than 65 mm Hg should be avoided in this age group.

The document acknowledges that systolic pressure may have to remain above 150 mm Hg if there is no response to four “well-selected drugs” or if there are unacceptable side effects. In these cases, the lowest “safely achieved” systolic blood pressure should be the goal.

Canadian Hypertension Education Program

The 2014 Canadian Hypertension Education Program (CHEP) report makes several recommendations for the “very elderly,” a group they define as over the age of 80. The CHEP website and resources include the following recommendations¹⁰:

• For the very elderly without diabetes or target-organ damage, drug therapy should be initiated when systolic blood pressure is higher than 160 mm Hg to reach a systolic blood pressure target lower than 150 mm Hg. This is a grade C level recommendation, indicating that it is based on low-quality trials, unvalidated surrogate outcomes, or results from nonrandomized observational studies.
• For the very elderly with macrovascular target-organ damage, antihypertensive therapy should be considered if systolic blood pressure readings average 140 mm Hg or higher (grade D for 140 to 160 mm Hg; grade A for higher than 160 mm Hg), although caution should be exercised in elderly patients who are frail. (Grade D recommendations are the weakest, as they are based on low-powered, imprecise studies or expert opinion, whereas grade A recommendations are based on the strongest evidence from high-quality randomized clinical trials.)
• Decisions regarding initiating and intensifying pharmacotherapy in the very elderly should be based on an individualized risk-benefit analysis.

The European Society of Hypertension and European Society of Cardiology

The 2013 guidelines from the European Society of Hypertension and the European Society of Cardiology¹¹ recommend that for elderly patients under age 80, antihypertensive treatment may be considered at systolic values higher than 140 mm Hg and aimed at values lower than 140 mm Hg if the patient is fit and treatment is well tolerated.

For those over age 80 with an initial systolic pressure of 160 mm Hg or higher, the guidelines recommend lowering systolic pressure to between 150 and 140 mm Hg, provided the patient is in good physical and mental condition. In frail elderly patients, they recommend leaving decisions on antihypertensive therapy to the treating physician, based on monitoring of the clinical effects of treatment.¹¹

The ADS/PATH guidelines

When finalizing our recommendations,¹ we considered the characteristics of frailty and the following key points from the evidence:

• Although evidence from drug treatment trials indicates that there is benefit in treating healthy older adults who have hypertension, the benefit of treating frail older adults is unknown.
• Major trials enrolled elderly patients only if they had systolic blood pressures of at least 160 mm Hg. Therefore, evidence supports initiating pharmacotherapy at a systolic pressure of 160 mm Hg or higher.
• No evidence from randomized controlled trials supports a systolic target lower than 140 mm Hg in the elderly, and there is some evidence that such a target does not benefit.
• The benefit of adding a third medication to lower blood pressure has not been studied.
• Frailty makes the potential benefits of strict blood pressure targets even less certain and increases the possibility of harm from adverse drug events.
• The only study of very old adults, HYVET,⁴⁴ enrolled relatively healthy older adults and few with orthostasis, while excluding those with a standing systolic blood pressure lower than 140 mm Hg.

OUR RECOMMENDATIONS

Based on the above, we advise against unnecessarily strict targets and recommend stopping antihypertensive medications that are used for the sole purpose of keeping the systolic blood pressure below 140 mm Hg. Our guidelines are unique in that they focus equally on when to stop and when to start medications. We concluded that without evidence of definitive benefit, “less is more” with frailty.⁵⁵ We believe that if physicians and health professionals understand the limitations of the evidence, they can be more confident in stopping medications that lower blood pressure to an unnecessarily low level.

We recommend the following (Table 4):

Before treating

• Carefully review the risks and the potential but unproven benefits of treatment.
• To avoid overtreatment, treatment decisions should be based on blood pressure measurements in the seated (not supine) position, while also considering the presence of orthostasis.
• To evaluate orthostasis, measure blood pressure in the supine position, then immediately on standing, and again after 2 minutes. Ask the patient if he or she feels light-headed or dizzy when standing.

Stop treatment

• If the seated systolic blood pressure is less than 140 mm Hg, medications can be tapered and discontinued to achieve the targets described below.
• Before discontinuation, consider whether the medications are treating additional conditions such as rate control for atrial fibrillation or symptomatic management of heart failure.
• It is uncertain whether to discontinue treatment when there is a history of stroke. Consider that treatment with two medications resulted in an absolute risk reduction for disabling stroke of 1.64% over approximately 4 years for adults with previous stroke and a mean age of 64,⁵⁷ an effect that may be more prominent at higher systolic pressures.

Start treatment

• Consider starting treatment when systolic pressure is 160 mm Hg or higher.
• Aim for a seated systolic pressure between 140 and 160 mm Hg if there are no adverse effects from treatment that affect quality of life.
• If there is symptomatic orthostasis or if standing systolic pressure is lower than 140 mm Hg, the target seated systolic pressure can be adjusted upwards.
• In the severely frail nearing the end of life, a target systolic pressure of 160 to 190 mm Hg is reasonable.
• The blood pressure target is the same in people with diabetes.
• In general, use no more than two medications.

Dissemination and implementation

The ADS/PATH guideline is intended for use by physicians and other health professionals (eg, pharmacists and nurses) who care for frail older adults or who work in long-term care facilities. Since creating our guideline, we have disseminated it to physicians, pharmacists, and other health professionals through academic detailing, large conferences, and interactive webinars.

While we do not have objective evidence of practice change, our evaluation data found that 34% of 403 family physicians who received academic detailing indicated that the guideline would change their practice, while 36% stated that the guideline confirmed their practice, an indication that family physicians are sensitive to the needs of the frail elderly.

Because health professionals may be wary of stopping medications and not meeting recommended targets, there may be barriers to adopting this guideline. However, our experience with the PATH program indicates that these barriers can be overcome using effective communication strategies between health professionals and consumers.

AN APPROACH APPROPRIATE TO FRAILTY

There is no direct evidence for systolic blood pressure targets in the frail elderly, so we applied evidence from the nonfrail elderly. Our recommendations differ somewhat from those of other groups, which recommend targets below 140 to 150 mm Hg for older adults, although some do advise caution in the elderly for whom a substantial fall in blood pressure might be poorly tolerated. Despite these messages, we believe that clearer guidance is needed to direct health practitioners toward models that acknowledge that frail patients are in a precarious balance of health and may be harmed by treatments that strive to lower blood pressure to unproven targets. For this reason, our guideline clearly indicates when to decrease or stop drug treatment.

After physicians and health professionals examine the evidence and more fully understand the benefits and harms of treating frail older adults, we are confident that they will be more comfortable stopping medications that lower blood pressure to an unnecessarily low level and instead use an approach that is more appropriate to frailty. We hope clinicians can use this guideline with the same enthusiasm applied to other guidelines, and we welcome discussion.

Acknowledgments: We would like to thank and acknowledge Tanya MacLeod and Kathryn Yuill for their review of and advice about the manuscript.

Frail older adults deserve guidelines that take frailty into account while assessing the potential benefit and risks of treatment.

Specifically, our group—the Dalhousie Academic Detailing Service (ADS) and the Palliative and Therapeutic Harmonization (PATH) program—recommends that physicians strive to achieve more liberal treatment targets for elderly frail patients who have high blood pressure,¹ as evidence does not support an aggressive approach in the frail elderly and the potential exists for harm.

This article reviews the evidence and reasoning that were used to develop and promote a guideline for drug treatment of hypertension in frail older adults. Our recommendations differ from other guidelines in that they focus as much on stopping or decreasing therapy as on starting or increasing it.

FRAILTY INCREASES THE RISK OF ADVERSE EFFECTS

The word frail, applied to older adults, describes those who have complex medical illnesses severe enough to compromise their ability to live independently.² Many have multiple coexisting medical problems for which they take numerous drugs, in addition to dementia, impaired mobility, compromised functional ability, or a history of falling.

Frailty denotes vulnerability; it increases the risk of adverse effects from medical and surgical procedures,³ complicates drug therapy,⁴ prolongs hospital length of stay,⁵ leads to functional and cognitive decline,⁶ increases the risk of institutionalization,⁷ and reduces life expectancy⁸—all of which affect the benefit and harm of medical treatments.

Guidelines for treating hypertension^9–11 now acknowledge that little evidence exists to support starting treatment for systolic blood pressure between 140 and 160 mm Hg or aiming for a target of less than 140 mm Hg for “very old” adults, commonly defined as over the age of 80. New guidelines loosen the treatment targets for the very old, but they do not specify targets for the frail and do not describe how to recognize or measure frailty.

RECOGNIZING AND MEASURING FRAILTY

A number of tools are available to recognize and measure frailty.¹²

The Fried frailty assessment¹³ has five items:

• Unintentional weight loss
• Self-reported exhaustion
• Weakness in grip
• Slow walking speed
• Low physical activity and energy expenditure.

People are deemed frail if they have three or more of these five. However, experts disagree about whether this system is too sensitive¹⁴ or not sensitive enough.^15,16

The FRAIL questionnaire¹⁷ also has five items:

• Fatigue
• Resistance (inability to climb stairs)
• Ambulation (inability to walk 1 city block)
• Illness (more than 5 major illnesses)
• Weight loss.

People are deemed frail if they have at least three of these five items, and “prefrail” if they have two.

These and other tools are limited by being dichotomous: they classify people as being either frail or not frail^18–20 but do not define the spectrum of frailty.

Other frailty assessments such as the Frailty Index²¹ identify frailty based on the number of accumulated health deficits but take a long time to complete, making them difficult to use in busy clinical settings.^22–24

The Clinical Frailty Scale⁷ is a validated scale that categorizes frailty based on physical and functional indicators of health, such as cognition, function, and mobility, with scores that range from 1 (very fit) to 9 (terminally ill).^7,12

The Frailty Assessment for Care-planning Tool (FACT) uses scaling compatible with the Clinical Frailty Scale but has been developed for use as a practical and interpretable frailty screening tool for nonexperts (Table 1). The FACT assesses cognition, mobility, function, and the social situation, using a combination of caregiver report and objective measures. To assess cognition, a health care professional uses items from the Mini-Cog²⁵ (ie, the ability to draw an analog clock face and then recall three unrelated items following the clock-drawing test) and the memory axis of the Brief Cognitive Rating Scale²⁶ (ie, the ability to recall current events, the current US president, and the names of children or spouse). Mobility, function, and social circumstance scores are assigned according to the caregiver report of the patient’s baseline status.

The FACT can be completed in busy clinical settings. Once a caregiver is identified, it takes about 5 minutes to complete.

Our guideline^27–31 is intended for those with a score of 7 or more on the Clinical Frailty Scale or FACT,^7,12 a score we chose because it describes people who are severely frail with shortened life expectancy.⁸ At this level, people need help with all instrumental activities of daily living (eg, handling finances, medication management, household chores, and shopping) as well as with basic activities of daily living such as bathing or dressing.

REVIEWING THE LIMITED EVIDENCE

We found no studies that addressed the risks and benefits of treating hypertension in frail older adults; therefore, we concentrated on studies that enrolled individuals who were chronologically old but not frail. We reviewed prominent guidelines,^9–11,32,33 the evidence base for these guidelines,^34–44 and Cochrane reviews.^45,46 A detailed description of the evidence used to build our recommendation can be found online.³¹

When we deliberated on treatment targets, we reviewed evidence from two types of randomized controlled trials⁴⁷:

Drug treatment trials randomize patients to different treatments, such as placebo versus a drug or one drug compared with another drug. Patients in different treatment groups may achieve different blood pressures and clinical outcomes, and this information is then used to define optimal targets. However, it may be difficult to determine if the benefit came from lowering blood pressure or from some other effect of the drug, which can be independent of blood pressure lowering.

Treat-to-target trials randomize patients to different blood pressure goals, but the groups are treated with the same or similar drugs. Therefore, any identified benefit can be attributed to the differences in blood pressure rather than the medications used. Compared with a drug treatment trial, this type of trial provides stronger evidence about optimal targets.

We also considered the characteristics of frailty, the dilemma of polypharmacy, and the relevance of the available scientific evidence to those who are frail.

Drug treatment trials

A Cochrane review⁴⁵ of 15 studies with approximately 24,000 elderly participants found that treating hypertension decreased the rates of cardiovascular morbidity and mortality as well as fatal and nonfatal stroke in the “elderly” (defined as age ≥ 60) and “very elderly” (age ≥ 80). However, in the very elderly, all-cause mortality rates were not statistically significantly different with treatment compared with placebo. The mean duration of treatment was 4.5 years in the elderly and 2.2 years in the very elderly (Table 2). Of importance, all the trials enrolled only those individuals whose systolic blood pressure was at least 160 mm Hg at baseline.

None of the studies were treat-to-target trials—patients were assigned either active medication or placebo. Thus, these trials provide evidence of benefit for treating hypertension in the elderly and very elderly but do not identify the optimal target. All of the drug treatment trials showed benefit, but none achieved a systolic pressure lower than 140 mm Hg with active treatment (Table 3). Therefore, these studies do not support a systolic target of less than 140 mm Hg in the elderly.

Treat-to-target trials: JATOS and VALISH

The Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients (JATOS)⁴² and the Valsartan in Elderly Isolated Systolic Hypertension (VALISH) study⁴³ each enrolled more than 3,000 people age 65 or older (mean age approximately 75). Patients were randomized to either a strict systolic target of less than 140 mm Hg or a higher (more permissive) target of 140 to 160 mm Hg in JATOS and 140 to 149 mm Hg in VALISH.

In both trials, the group with strict targets achieved a systolic pressure of approximately 136 mm Hg, while the group with higher blood pressure targets achieved a systolic pressure of 146 mm Hg in JATOS and 142 mm Hg in VALISH. Despite these differences, there was no statistically significant difference in the primary outcome.

Thus, treat-to-target studies also fail to support a systolic target of less than 140 mm Hg in the elderly, although it is important to recognize the limitations of the studies. Approximately 15% of the participants had cardiovascular disease, so the applicability of the findings to patients with target-organ damage is uncertain. In addition, there were fewer efficacy outcome events than expected, which suggests that the studies were underpowered.

When to start drug treatment

In each of the drug treatment and treat-to-target trials, the inclusion criterion for study entry was a systolic blood pressure above 160 mm Hg, with a mean blood pressure at entry into the drug treatment trials of 182/95 mm Hg.⁴⁶ Thus, data support starting treatment if the systolic blood pressure is above 160 mm Hg, but not lower.

Notably, in all but one study,⁴⁶ at least two-thirds of the participants took no more than two antihypertensive medications. Since adverse events become more common as the number of medications increases, the benefit of adding a third drug to lower blood pressure is uncertain.

Evidence in the ‘very elderly’: HYVET

With the exception of the Hypertension in the Very Elderly Trial (HYVET),⁴⁴ the mean age of elderly patients in the reported studies was between 67 and 76.

HYVET patients were age 80 and older (mean age 84) and were randomized to receive either indapamide (with or without perindopril) or placebo. The trial was stopped early at 2 years because the mortality rate was lower in the treatment group (10.1%) than in the placebo group (12.3%) (number needed to treat 46, 95% confidence interval 24–637, P = .02). There was no significant difference in the primary outcome of fatal and nonfatal stroke.

Notably, trials that are stopped early may overestimate treatment benefit.⁴⁸

Evidence in frail older adults

While the above studies provide some information about managing hypertension in the elderly, the participants were generally healthy. HYVET⁴⁴ specifically excluded those with a standing systolic blood pressure of less than 140 mm Hg and enrolled few patients with orthostasis (7.9% in the placebo group and 8.8% in the treatment group), a condition commonly associated with frailty. As such, these studies may be less relevant to the frail elderly, who are at higher risk of adverse drug events and have competing risks for morbidity and mortality.

Observational studies, in fact, raise questions about whether tight blood pressure control improves clinical outcomes for the very elderly. In the Leiden 85-plus study, lower systolic blood pressure was associated with lower cognitive scores, worse functional ability,^49,50 and a higher mortality rate⁵¹ compared with higher systolic pressure, although it is uncertain whether these outcomes were indicative of underlying disease that could result in lower blood pressure or an effect of blood pressure-lowering.

The National Health and Nutrition Examination Survey⁵² found an association between blood pressure and mortality rate that varied by walking speed. For slower walkers (based on the 6-minute walk test), higher systolic pressures were not associated with a higher risk of death, suggesting that when older adults are frail (as indicated by their slow walking speed) they are less likely to benefit from aggressive treatment of hypertension.

People at high risk because of stroke

Because the evidence is limited, it is even more difficult to judge whether lowering blood pressure below 140 mm Hg is beneficial for frail patients who have a history of stroke, compared with the possibility that medications will cause adverse effects such as weakness, orthostasis, and falls. When reviewing the evidence to answer this question, we especially looked at outcomes that affect quality of life, such as nonfatal stroke leading to disability. In contrast, because the frail elderly have competing causes of mortality, we could not assume that a mortality benefit shown in nonfrail populations could be applied to frail populations.

The PROGRESS trial (Perindopril Protection Against Recurrent Stroke Study)⁵³ was in patients with a history of stroke or transient ischemic attack and a mean age of 64, who were treated with either perindopril (with or without indapamide) or placebo.

At almost 4 years, the rate of disabling stroke was 2.7% in the treatment group and 4.3% in the placebo group, a relative risk reduction of 38% and an absolute risk reduction of 1.64% (number needed to treat 61, 95% confidence interval 39–139). The relative risk reduction for all strokes (fatal and nonfatal) was similar across a range of baseline systolic pressures, but the absolute risk reduction was greater in the prespecified subgroup that had hypertension at baseline (mean blood pressure 159/94 mm Hg) than in the normotensive subgroup (mean blood pressure 136/79 mm Hg), suggesting that treatment is most beneficial for those with higher systolic blood pressures. Also, the benefit was only demonstrated in the subgroup that received two antihypertensive medications; those who received perindopril alone showed no benefit.

This study involved relatively young patients in relatively good health except for their strokes. The extent to which the results can be extrapolated to older, frail adults is uncertain because of the time needed to achieve benefit and because of the added vulnerability of frailty, which could make treatment with two antihypertensive medications riskier.

PRoFESS (Prevention Regimen for Effectively Avoiding Second Strokes),⁵⁴ another study in patients with previous stroke (mean age 66) showed no benefit over 2.5 years in the primary outcome of stroke using telmesartan 80 mg daily compared with placebo. This result is concordant with that of PROGRESS,⁵³ in which patients who took only one medication did not show a significant decrease in the rate of stroke.

A possible reason for the lack of benefit from monotherapy was that the differences in blood pressure between the placebo group and the treatment group on monotherapy were small in both studies (3.8/2.0 mm Hg in PRoFESS, 5/3 mm Hg in PROGRESS). In contrast, patients on dual therapy in PROGRESS decreased their blood pressure by 12/5 mm Hg compared with placebo.

CURRENT HYPERTENSION GUIDELINES

Current guidelines make reference to the elderly, but we found none that made specific recommendations for the frail elderly.

JNC 8

In December 2013, members of the Eighth Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8) released new recommendations.³² One significant revision was to support higher blood pressure targets for older adults (age 60 and older). Whereas JNC 7 stated that lowering blood pressure below 140/90 mm Hg reduced cardiovascular complications,³³ JNC 8 now acknowledges that there is no strong evidence to support blood pressure targets below 150/90 mm Hg for hypertensive persons without kidney disease or diabetes age 60 and older. Thus, in the general population age 60 and older, JNC 8 recommends starting antihypertensive treatment when blood pressure is 150/90 mm Hg or higher, and treating to a goal blood pressure of less than 150/90 mm Hg. JNC 8 makes no recommendation about how to adjust blood pressure targets for frailty or how to measure blood pressure.

American College of Cardiology and American Heart Association

In 2011, the American College of Cardiology and American Heart Association published a consensus document on the management of hypertension in the elderly.⁹

They acknowledged that the generally recommended blood pressure goal of lower than 140/90 mm Hg in uncomplicated elderly patients is based on expert opinion rather than on data from randomized controlled trials, but nevertheless recommended a target systolic pressure lower than 140 mm Hg for older adults, except for octogenarians.

For those over age 80, systolic levels of 140 to 145 mm Hg can be acceptable if tolerated and if the patient does not experience orthostasis when standing. Systolic pressure lower than 130 mm Hg and diastolic pressures lower than 65 mm Hg should be avoided in this age group.

The document acknowledges that systolic pressure may have to remain above 150 mm Hg if there is no response to four “well-selected drugs” or if there are unacceptable side effects. In these cases, the lowest “safely achieved” systolic blood pressure should be the goal.

Canadian Hypertension Education Program

The 2014 Canadian Hypertension Education Program (CHEP) report makes several recommendations for the “very elderly,” a group they define as over the age of 80. The CHEP website and resources include the following recommendations¹⁰:

• For the very elderly without diabetes or target-organ damage, drug therapy should be initiated when systolic blood pressure is higher than 160 mm Hg to reach a systolic blood pressure target lower than 150 mm Hg. This is a grade C level recommendation, indicating that it is based on low-quality trials, unvalidated surrogate outcomes, or results from nonrandomized observational studies.
• For the very elderly with macrovascular target-organ damage, antihypertensive therapy should be considered if systolic blood pressure readings average 140 mm Hg or higher (grade D for 140 to 160 mm Hg; grade A for higher than 160 mm Hg), although caution should be exercised in elderly patients who are frail. (Grade D recommendations are the weakest, as they are based on low-powered, imprecise studies or expert opinion, whereas grade A recommendations are based on the strongest evidence from high-quality randomized clinical trials.)
• Decisions regarding initiating and intensifying pharmacotherapy in the very elderly should be based on an individualized risk-benefit analysis.

The European Society of Hypertension and European Society of Cardiology

The 2013 guidelines from the European Society of Hypertension and the European Society of Cardiology¹¹ recommend that for elderly patients under age 80, antihypertensive treatment may be considered at systolic values higher than 140 mm Hg and aimed at values lower than 140 mm Hg if the patient is fit and treatment is well tolerated.

For those over age 80 with an initial systolic pressure of 160 mm Hg or higher, the guidelines recommend lowering systolic pressure to between 150 and 140 mm Hg, provided the patient is in good physical and mental condition. In frail elderly patients, they recommend leaving decisions on antihypertensive therapy to the treating physician, based on monitoring of the clinical effects of treatment.¹¹

The ADS/PATH guidelines

When finalizing our recommendations,¹ we considered the characteristics of frailty and the following key points from the evidence:

• Although evidence from drug treatment trials indicates that there is benefit in treating healthy older adults who have hypertension, the benefit of treating frail older adults is unknown.
• Major trials enrolled elderly patients only if they had systolic blood pressures of at least 160 mm Hg. Therefore, evidence supports initiating pharmacotherapy at a systolic pressure of 160 mm Hg or higher.
• No evidence from randomized controlled trials supports a systolic target lower than 140 mm Hg in the elderly, and there is some evidence that such a target does not benefit.
• The benefit of adding a third medication to lower blood pressure has not been studied.
• Frailty makes the potential benefits of strict blood pressure targets even less certain and increases the possibility of harm from adverse drug events.
• The only study of very old adults, HYVET,⁴⁴ enrolled relatively healthy older adults and few with orthostasis, while excluding those with a standing systolic blood pressure lower than 140 mm Hg.

OUR RECOMMENDATIONS

Based on the above, we advise against unnecessarily strict targets and recommend stopping antihypertensive medications that are used for the sole purpose of keeping the systolic blood pressure below 140 mm Hg. Our guidelines are unique in that they focus equally on when to stop and when to start medications. We concluded that without evidence of definitive benefit, “less is more” with frailty.⁵⁵ We believe that if physicians and health professionals understand the limitations of the evidence, they can be more confident in stopping medications that lower blood pressure to an unnecessarily low level.

We recommend the following (Table 4):

Before treating

• Carefully review the risks and the potential but unproven benefits of treatment.
• To avoid overtreatment, treatment decisions should be based on blood pressure measurements in the seated (not supine) position, while also considering the presence of orthostasis.
• To evaluate orthostasis, measure blood pressure in the supine position, then immediately on standing, and again after 2 minutes. Ask the patient if he or she feels light-headed or dizzy when standing.

Stop treatment

• If the seated systolic blood pressure is less than 140 mm Hg, medications can be tapered and discontinued to achieve the targets described below.
• Before discontinuation, consider whether the medications are treating additional conditions such as rate control for atrial fibrillation or symptomatic management of heart failure.
• It is uncertain whether to discontinue treatment when there is a history of stroke. Consider that treatment with two medications resulted in an absolute risk reduction for disabling stroke of 1.64% over approximately 4 years for adults with previous stroke and a mean age of 64,⁵⁷ an effect that may be more prominent at higher systolic pressures.

Start treatment

• Consider starting treatment when systolic pressure is 160 mm Hg or higher.
• Aim for a seated systolic pressure between 140 and 160 mm Hg if there are no adverse effects from treatment that affect quality of life.
• If there is symptomatic orthostasis or if standing systolic pressure is lower than 140 mm Hg, the target seated systolic pressure can be adjusted upwards.
• In the severely frail nearing the end of life, a target systolic pressure of 160 to 190 mm Hg is reasonable.
• The blood pressure target is the same in people with diabetes.
• In general, use no more than two medications.

Dissemination and implementation

The ADS/PATH guideline is intended for use by physicians and other health professionals (eg, pharmacists and nurses) who care for frail older adults or who work in long-term care facilities. Since creating our guideline, we have disseminated it to physicians, pharmacists, and other health professionals through academic detailing, large conferences, and interactive webinars.

While we do not have objective evidence of practice change, our evaluation data found that 34% of 403 family physicians who received academic detailing indicated that the guideline would change their practice, while 36% stated that the guideline confirmed their practice, an indication that family physicians are sensitive to the needs of the frail elderly.

Because health professionals may be wary of stopping medications and not meeting recommended targets, there may be barriers to adopting this guideline. However, our experience with the PATH program indicates that these barriers can be overcome using effective communication strategies between health professionals and consumers.

AN APPROACH APPROPRIATE TO FRAILTY

There is no direct evidence for systolic blood pressure targets in the frail elderly, so we applied evidence from the nonfrail elderly. Our recommendations differ somewhat from those of other groups, which recommend targets below 140 to 150 mm Hg for older adults, although some do advise caution in the elderly for whom a substantial fall in blood pressure might be poorly tolerated. Despite these messages, we believe that clearer guidance is needed to direct health practitioners toward models that acknowledge that frail patients are in a precarious balance of health and may be harmed by treatments that strive to lower blood pressure to unproven targets. For this reason, our guideline clearly indicates when to decrease or stop drug treatment.

After physicians and health professionals examine the evidence and more fully understand the benefits and harms of treating frail older adults, we are confident that they will be more comfortable stopping medications that lower blood pressure to an unnecessarily low level and instead use an approach that is more appropriate to frailty. We hope clinicians can use this guideline with the same enthusiasm applied to other guidelines, and we welcome discussion.

Acknowledgments: We would like to thank and acknowledge Tanya MacLeod and Kathryn Yuill for their review of and advice about the manuscript.