- Kenny Lin, MD, MPH
Can't sleep? Then spend your extra awake time reading the latest installment of Implementing AHRQ Effective Care Reviews in the September 1 issue of AFP, on management of insomnia disorder in adults. This evidence review, which supported an American College of Physicians practice guideline, examined the effectiveness of behavioral therapies and medications for adults with insomnia disorder, defined as "poor sleep quality or quantity that causes distress or dysfunction and lasts for longer than three months."
The most beneficial sleep intervention overall is cognitive behavior therapy for insomnia (CBT-I), which produced sustained improvements for at least 6 months. CBT-I consists of cognitive therapy, sleep restriction and stimulus control, and sleep hygiene education. Medications that have sufficient evidence demonstrating improvement in short-term (3 months or less) sleep outcomes include eszopiclone, zolpidem, and suvorexant; there was insufficient data to evaluate benzodiazepines or over-the-counter sleep aids (diphenhydramine, doxylamine, or melatonin). For most patients, medications should not be prescribed for longer than five weeks.
Physicians commonly prescribe antipsychotics off-label to treat insomnia in older persons. The Practice Guidelines in the September 15 issue summarized a Canadian guideline for deprescribing antipsychotics for behavioral and psychological symptoms of dementia and insomnia, produced by the Deprescribing Guidelines in the Elderly Project. Due to the potential harms of these medications and the lack of evidence of benefits (a single randomized trial with 13 participants found nonsignificant differences in sleep latency in patients taking quetiapine), the guideline recommends that antipsychotics prescribed for primary or secondary insomnia in which comorbidities are under control be discontinued without tapering, regardless of treatment duration.
AFP's sister journal, FPM, recently published an article on deprescribing unnecessary medications that featured a four-step process (review current medications; identify inappropriate, unnecessary, or harmful medications; plan deprescribing with the patient; and regularly re-review medications) and links to additional resources on medication reconciliation and deprescribing. You can find more information on sleep disorders in adults in our AFP By Topic collection.
Monday, September 24, 2018
Monday, September 17, 2018
Cervical cancer screening in the age of HPV vaccination
- Jennifer Middleton, MD, MPH
A POEM (Patient-Oriented Evidence that Matters) in the current edition of AFP suggests the potential for change in cervical cancer screening practices; screening younger women only with human papillomavirus (HPV) testing, and not cytology, resulted in better identification of high grade pre-cancerous disease in individuals who have received the HPV vaccine.
This study from Australia enrolled nearly 5,000 women aged 25-64 presenting for cervical cancer screening to one of three groups: liquid-based cytology screening followed by HPV testing if abnormal, HPV screening followed by liquid-based cytology as indicated, or HPV screening followed by dual-stained cytology (staining for high-risk HPV markers) as indicated. At the time of the study, women 33 years old or younger had been eligible to receive the HPV vaccine when it was first available in Australia; in these women, both of the HPV screening groups had a higher rate of pre-cancerous disease detection than the cytology-based screening group.
The United States Preventive Services Task Force (USPSTF) currently recommends HPV screening every 5 years as an option only for women aged 30 and older along with screening every 3 years with cytology alone or screening every 5 years with cytology and HPV co-testing; they recommend discussing risks (HPV screening alone and HPV/cytology co-testing both have an increased rate of false positive screening results, while cytology alone may miss some true positives) of each method with individuals to personalize screening decisions. For women aged 21-29, the USPSTF only recommends cervical cancer screening with cytology alone every 3 years. The American College of Gynecology and Obstetrics does not allow for the option of HPV testing alone for women of any age, but otherwise their recommendations align with the USPSTF.
HPV vaccine acceptance and uptake has been quite high in Australia, with the study authors citing that 70-78% of women aged 12-17 years were fully vaccinated in 2013. In the United States, HPV vaccine uptake has been less successful; the Centers for Disease Control (CDC) estimates that half of US teens have not completed the HPV series (you can find specific data for your state using this interactive map). It's possible that this POEM's findings may not be generalizable to the US given this difference in vaccination rates, but studies have also supported the sole use of HPV screening in women who were beyond vaccination age when HPV vaccine was introduced in the US.
Regardless, HPV vaccination rates have plenty of room for improvement in the US. Barriers to increasing HPV vaccination in the US, as outlined in this 2016 AFP Community Blog post by Dr. Lin, include safety concerns and parental worry about the vaccine encouraging earlier initiation of sexual activity (it doesn't). Physicians, too, are sometimes reluctant to discuss or recommend the vaccine. Strategies to overcome these barriers include reviewing vaccinations at every visit (not just well visits) as recommended by the authors of this 2015 AFP editorial on "HPV Vaccination: Overcoming Parental and Physician Impediments." The CDC also advises physicians to recommend HPV vaccine "the same way, the same day as other vaccines." Identifying office workflow barriers, implementing previsit planning, and permitting walk-in vaccinations can help increase vaccine uptake as well. There's an AFP by Topic on Immunizations (excluding Influenza) with several other resources on discussing vaccine hesitancy and increasing vaccination rates if you'd like to read more.
A POEM (Patient-Oriented Evidence that Matters) in the current edition of AFP suggests the potential for change in cervical cancer screening practices; screening younger women only with human papillomavirus (HPV) testing, and not cytology, resulted in better identification of high grade pre-cancerous disease in individuals who have received the HPV vaccine.
This study from Australia enrolled nearly 5,000 women aged 25-64 presenting for cervical cancer screening to one of three groups: liquid-based cytology screening followed by HPV testing if abnormal, HPV screening followed by liquid-based cytology as indicated, or HPV screening followed by dual-stained cytology (staining for high-risk HPV markers) as indicated. At the time of the study, women 33 years old or younger had been eligible to receive the HPV vaccine when it was first available in Australia; in these women, both of the HPV screening groups had a higher rate of pre-cancerous disease detection than the cytology-based screening group.
The United States Preventive Services Task Force (USPSTF) currently recommends HPV screening every 5 years as an option only for women aged 30 and older along with screening every 3 years with cytology alone or screening every 5 years with cytology and HPV co-testing; they recommend discussing risks (HPV screening alone and HPV/cytology co-testing both have an increased rate of false positive screening results, while cytology alone may miss some true positives) of each method with individuals to personalize screening decisions. For women aged 21-29, the USPSTF only recommends cervical cancer screening with cytology alone every 3 years. The American College of Gynecology and Obstetrics does not allow for the option of HPV testing alone for women of any age, but otherwise their recommendations align with the USPSTF.
HPV vaccine acceptance and uptake has been quite high in Australia, with the study authors citing that 70-78% of women aged 12-17 years were fully vaccinated in 2013. In the United States, HPV vaccine uptake has been less successful; the Centers for Disease Control (CDC) estimates that half of US teens have not completed the HPV series (you can find specific data for your state using this interactive map). It's possible that this POEM's findings may not be generalizable to the US given this difference in vaccination rates, but studies have also supported the sole use of HPV screening in women who were beyond vaccination age when HPV vaccine was introduced in the US.
Regardless, HPV vaccination rates have plenty of room for improvement in the US. Barriers to increasing HPV vaccination in the US, as outlined in this 2016 AFP Community Blog post by Dr. Lin, include safety concerns and parental worry about the vaccine encouraging earlier initiation of sexual activity (it doesn't). Physicians, too, are sometimes reluctant to discuss or recommend the vaccine. Strategies to overcome these barriers include reviewing vaccinations at every visit (not just well visits) as recommended by the authors of this 2015 AFP editorial on "HPV Vaccination: Overcoming Parental and Physician Impediments." The CDC also advises physicians to recommend HPV vaccine "the same way, the same day as other vaccines." Identifying office workflow barriers, implementing previsit planning, and permitting walk-in vaccinations can help increase vaccine uptake as well. There's an AFP by Topic on Immunizations (excluding Influenza) with several other resources on discussing vaccine hesitancy and increasing vaccination rates if you'd like to read more.
Monday, September 10, 2018
Continue to Choose Wisely: updates to the AAFP Choosing Wisely recommendations
- Sarah Coles, MD and James Stevermer, MD
Providing high value, safe, and cost-effective care is the cornerstone of family medicine. However, there remains significant overutilization of low-value or even harmful care in the U.S. health care system. The American Academy of Family Physicians (AAFP) partnered with the Choosing Wisely Campaign to identify care that may be overused or misused and tackle this pressing issue. Founded in 2012 as an initiative of the American Board of Internal Medicine Foundation, the Choosing Wisely campaign collates lists of procedures and tests that add little or no value to medical care. The AAFP was one of the first organizations to participate, submitting 5 initial recommendations and a total of 15 recommendations by 2013.
Once again, the AAFP has added 5 new recommendations to the Choosing Wisely campaign. Developed by the AAFP's Commission on Health of the Public and Science, these evidence-based recommendations are based on sources such as the Cochrane Collaboration and the Agency for Healthcare Research and Quality systematic reviews. Each recommendation focuses on a practice that is either harmful or has very little supporting evidence of benefit.
Here are the new recommendations:
Don’t perform pelvic exams on asymptomatic nonpregnant women, unless necessary for guideline-appropriate screening for cervical cancer.
Screening pelvic examinations, except for the purpose of performing cervical cancer screening at recommended intervals, have not led to reduction in mortality or morbidity. Additionally, they increase costs and expose asymptomatic women to unnecessary invasive testing.
Don’t routinely recommend daily home glucose monitoring for patients who have Type 2 diabetes mellitus and are not using insulin.
Self-monitoring of blood glucose (SMBG) has no demonstrated benefit in patients with type 2 diabetes mellitus who are not on insulin or medications associated with hypoglycemia. SMBG should be reserved for patients during the titration of their medication doses or during periods of changes in patients’ diet and exercise routines.
Don’t screen for genital herpes simplex virus infection (HSV) in asymptomatic adults, including pregnant women.
Serologic testing for HSV infection has low specificity and a high false-positive rate. No confirmatory test is currently available and the serologic tests cannot determine the site of infection. Given the prevalence of the infection in the United States, the positive predictive value of the test is estimated at about 50%. A positive test can cause considerable anxiety and disruption of personal relationships.
Don’t screen for testicular cancer in asymptomatic adolescent and adult males.
There is no benefit to screening for testicular cancer due to the low incidence of disease and high cure rates of treatment, even in patients who have advanced disease. Potential harms include false-positive results, anxiety, and harms from diagnostic tests or procedures.
Don’t transfuse more than the minimum of red blood cell (RBC) units necessary to relieve symptoms of anemia or to return a patient to a safe hemoglobin range (7 to 8 g/dL in stable patients).
Unnecessary transfusion exposes patients to potential adverse effects without any likelihood of benefit and generates additional costs.
Using tools like Choosing Wisely, family physicians can lead change and reduce unnecessary care in the US to cut costs, improve health outcomes, and limit harms. To help you put Choosing Wisely into practice, you can find the lists from the AAFP and over 80 other specialty organizations at choosingwisely.org and a search tool for primary care-relevant recommendations on the AFP website.
Providing high value, safe, and cost-effective care is the cornerstone of family medicine. However, there remains significant overutilization of low-value or even harmful care in the U.S. health care system. The American Academy of Family Physicians (AAFP) partnered with the Choosing Wisely Campaign to identify care that may be overused or misused and tackle this pressing issue. Founded in 2012 as an initiative of the American Board of Internal Medicine Foundation, the Choosing Wisely campaign collates lists of procedures and tests that add little or no value to medical care. The AAFP was one of the first organizations to participate, submitting 5 initial recommendations and a total of 15 recommendations by 2013.
Once again, the AAFP has added 5 new recommendations to the Choosing Wisely campaign. Developed by the AAFP's Commission on Health of the Public and Science, these evidence-based recommendations are based on sources such as the Cochrane Collaboration and the Agency for Healthcare Research and Quality systematic reviews. Each recommendation focuses on a practice that is either harmful or has very little supporting evidence of benefit.
Here are the new recommendations:
Don’t perform pelvic exams on asymptomatic nonpregnant women, unless necessary for guideline-appropriate screening for cervical cancer.
Screening pelvic examinations, except for the purpose of performing cervical cancer screening at recommended intervals, have not led to reduction in mortality or morbidity. Additionally, they increase costs and expose asymptomatic women to unnecessary invasive testing.
Don’t routinely recommend daily home glucose monitoring for patients who have Type 2 diabetes mellitus and are not using insulin.
Self-monitoring of blood glucose (SMBG) has no demonstrated benefit in patients with type 2 diabetes mellitus who are not on insulin or medications associated with hypoglycemia. SMBG should be reserved for patients during the titration of their medication doses or during periods of changes in patients’ diet and exercise routines.
Don’t screen for genital herpes simplex virus infection (HSV) in asymptomatic adults, including pregnant women.
Serologic testing for HSV infection has low specificity and a high false-positive rate. No confirmatory test is currently available and the serologic tests cannot determine the site of infection. Given the prevalence of the infection in the United States, the positive predictive value of the test is estimated at about 50%. A positive test can cause considerable anxiety and disruption of personal relationships.
Don’t screen for testicular cancer in asymptomatic adolescent and adult males.
There is no benefit to screening for testicular cancer due to the low incidence of disease and high cure rates of treatment, even in patients who have advanced disease. Potential harms include false-positive results, anxiety, and harms from diagnostic tests or procedures.
Don’t transfuse more than the minimum of red blood cell (RBC) units necessary to relieve symptoms of anemia or to return a patient to a safe hemoglobin range (7 to 8 g/dL in stable patients).
Unnecessary transfusion exposes patients to potential adverse effects without any likelihood of benefit and generates additional costs.
Using tools like Choosing Wisely, family physicians can lead change and reduce unnecessary care in the US to cut costs, improve health outcomes, and limit harms. To help you put Choosing Wisely into practice, you can find the lists from the AAFP and over 80 other specialty organizations at choosingwisely.org and a search tool for primary care-relevant recommendations on the AFP website.
**
Drs. Coles and Stevermer are members of the AAFP's Commission on Health of the Public and Science. Dr. Coles is also an AFP Contributing Editor and Assistant Editor, AFP Podcast.
Tuesday, September 4, 2018
Is aspirin effective primary prevention for CVD?
- Jennifer Middleton, MD, MPH
Two recent studies challenge the premise that adults at increased risk of cardiovascular disease (CVD) should take a daily aspirin. More specifically, the United States Preventive Services Task Force (USPSTF) currently recommends that adults aged 50-59 with a 10-year risk of CVD of at least 10% take a daily low-dose aspirin. One of the studies published earlier this week, however, found no benefit to daily aspirin use regarding primary prevention of CVD but did find an increased risk of gastrointestinal (GI) bleeding; the other study found that aspirin did decrease the risk of initial CVD events in its participants with diabetes but it also, again, increased the risk of GI bleeding.
The first study, the ARRIVE study, enrolled over 12,000 participants across several countries (most participants came from the United Kingdom, Germany, and Poland) deemed to be at "moderate" risk of CVD based on a lengthy list of criteria that resulted in a mean ASCVD risk score for participants of approximately 17%. Participants were randomized into either the aspirin (100 mg of enteric-coated aspirin a day) group or the placebo group and were followed for an average of 5 years. The researchers' primary outcome was a composite of first occurrence of cardiovascular death, myocardial infarction, unstable angina, stroke, or transient ischemic attack. There was no difference in the rate of these events between the aspirin and the placebo groups (hazard ratio 0.96; 95% confidence interval [0.81-1.13]), but the aspirin group had a higher rate of GI bleeding events (hazard ratio 2.11; 95% confidence interval [1.36-3.28]).
Interestingly, though the mean ASCVD risk score for enrolled participants was 17.3-17.4%, the rate of CVD events that actually occurred among participants was much lower; only 4.29-4.48% of participants had a CVD event during this study. The researchers attribute this difference to good management of non-acute CVD symptoms and note this trial was intentionally "pragmatic" in this regard, though they do also concede that "risk calculators developed with older data might overestimate risk in current practice." Concerns about the ASCVD risk score's propensity to inflate CVD risk are not new and have even been acknowledged within the cardiology community. Unfortunately, as the USPSTF notes in their statement, "although concerns have been raised about the equations’ potential to overpredict risk and their moderate discrimination, they are the only U.S.-based, externally validated equations that report risk as a combination of cerebrovascular and CHD events."
The second study, the ASCEND study, enrolled over 15,000 participants across the United Kingdom with diabetes but without known CVD and randomized them into daily aspirin (100 mg of aspirin a day) or placebo groups. Participants were followed for an average of 7.4 years. Unlike the ARRIVE study, the ASCEND researchers found that CVD events were decreased in the aspirin group (relative risk 0.88; 95% confidence interval [0.79-0.97]), but, similar to ARRIVE, GI events were increased in the aspirin group (relative risk 1.29; 95% confidence interval [1.09-1.52]). The researchers concluded that "[t]he absolute benefits were largely counterbalanced by the bleeding hazard." Additionally, "91 patients would need to be treated to avoid a serious vascular event over a period of 7.4 years, and 112 to cause a major bleeding event."
Both of these studies looked at relatively high risk populations for CVD and had a large number of participants. The ARRIVE study's participants did not have diabetes, while the ASCEND study's participants did. Both groups of researchers, however, came to the same conclusion: the risks of taking daily aspirin for primary prevention of CVD outweigh any possible benefit.
Dr. Lin and I have both previously written about aspirin as primary prevention on the blog, and you can count on AFP to continue bringing you the latest evidence to inform your practice. Will these new studies change your recommendations about aspirin for primary prevention of CVD?
Two recent studies challenge the premise that adults at increased risk of cardiovascular disease (CVD) should take a daily aspirin. More specifically, the United States Preventive Services Task Force (USPSTF) currently recommends that adults aged 50-59 with a 10-year risk of CVD of at least 10% take a daily low-dose aspirin. One of the studies published earlier this week, however, found no benefit to daily aspirin use regarding primary prevention of CVD but did find an increased risk of gastrointestinal (GI) bleeding; the other study found that aspirin did decrease the risk of initial CVD events in its participants with diabetes but it also, again, increased the risk of GI bleeding.
The first study, the ARRIVE study, enrolled over 12,000 participants across several countries (most participants came from the United Kingdom, Germany, and Poland) deemed to be at "moderate" risk of CVD based on a lengthy list of criteria that resulted in a mean ASCVD risk score for participants of approximately 17%. Participants were randomized into either the aspirin (100 mg of enteric-coated aspirin a day) group or the placebo group and were followed for an average of 5 years. The researchers' primary outcome was a composite of first occurrence of cardiovascular death, myocardial infarction, unstable angina, stroke, or transient ischemic attack. There was no difference in the rate of these events between the aspirin and the placebo groups (hazard ratio 0.96; 95% confidence interval [0.81-1.13]), but the aspirin group had a higher rate of GI bleeding events (hazard ratio 2.11; 95% confidence interval [1.36-3.28]).
Interestingly, though the mean ASCVD risk score for enrolled participants was 17.3-17.4%, the rate of CVD events that actually occurred among participants was much lower; only 4.29-4.48% of participants had a CVD event during this study. The researchers attribute this difference to good management of non-acute CVD symptoms and note this trial was intentionally "pragmatic" in this regard, though they do also concede that "risk calculators developed with older data might overestimate risk in current practice." Concerns about the ASCVD risk score's propensity to inflate CVD risk are not new and have even been acknowledged within the cardiology community. Unfortunately, as the USPSTF notes in their statement, "although concerns have been raised about the equations’ potential to overpredict risk and their moderate discrimination, they are the only U.S.-based, externally validated equations that report risk as a combination of cerebrovascular and CHD events."
The second study, the ASCEND study, enrolled over 15,000 participants across the United Kingdom with diabetes but without known CVD and randomized them into daily aspirin (100 mg of aspirin a day) or placebo groups. Participants were followed for an average of 7.4 years. Unlike the ARRIVE study, the ASCEND researchers found that CVD events were decreased in the aspirin group (relative risk 0.88; 95% confidence interval [0.79-0.97]), but, similar to ARRIVE, GI events were increased in the aspirin group (relative risk 1.29; 95% confidence interval [1.09-1.52]). The researchers concluded that "[t]he absolute benefits were largely counterbalanced by the bleeding hazard." Additionally, "91 patients would need to be treated to avoid a serious vascular event over a period of 7.4 years, and 112 to cause a major bleeding event."
Both of these studies looked at relatively high risk populations for CVD and had a large number of participants. The ARRIVE study's participants did not have diabetes, while the ASCEND study's participants did. Both groups of researchers, however, came to the same conclusion: the risks of taking daily aspirin for primary prevention of CVD outweigh any possible benefit.
Dr. Lin and I have both previously written about aspirin as primary prevention on the blog, and you can count on AFP to continue bringing you the latest evidence to inform your practice. Will these new studies change your recommendations about aspirin for primary prevention of CVD?
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