Contraceptive counseling and provision in clinical practice increases its use and reduces unintended pregnancy

Editorial urgently calls for contraceptive counseling to become a routine part of primary care

Abstract: https://www.acpjournals.org/doi/10.7326/M21-4380      

Editorial: https://www.acpjournals.org/doi/10.7326/M22-1485 

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A review and meta-analysis of 38 randomized controlled trials found that counseling patients about contraceptive use and providing contraceptives for patients wanting them in various clinical practice settings increases contraceptive use without increasing the risk for sexually transmitted infections (STIs) or reducing condom use compared to usual practice. Counseling and provision interventions also decrease unintended pregnancy in trials designed to evaluate this outcome. At a time when abortion rights are threatened, an accompanying editorial suggests that contraceptive counseling and provision must immediately become a routine part of medical care. The analysis is published in Annals of Internal Medicine.

Contraceptive care supports patients in achieving their reproductive goals by providing counseling, provision, and follow-up services as needed. Contraceptive care is a standard preventive health service in the United States, and the use and safety of contraceptives are well-established through both professional organization recommendations and Food and Drug Administration clearances. However, access to and coverage of contraceptive care can be limited.

Dr. Heidi D. Nelson from the Kaiser Permanente Bernard J. Tyson School of Medicine was principal investigator of the study that included a team of researchers from the Oregon Health and Science University and University of Southern Maine and was funded by the Resources Legacy Fund. The team analyzed 38 randomized controlled trials of the effectiveness of contraceptive counseling and provision interventions for women to increase use of contraceptives and reduce unintended pregnancy. The trials demonstrated the effectiveness of enhanced contraceptive counseling, provision, and follow-up services; providing emergency contraception in advance; and delivering services immediately postpartum or at the time of abortion. Results showed consistently higher contraceptive use during the months following the interventions for adolescents and women compared to usual care or controls, such as receiving educational materials without accompanying counseling. Unintended pregnancy was also reduced in the few trials designed for this outcome. The trials also indicated no adverse effects of counseling and provision interventions related to STIs or condom use, although none evaluated additional potential harms, such as anxiety, stigma, and reproductive coercion.

An accompanying editorial by Annals editor in chief Dr. Christine Laine highlights the importance of the effectiveness of contraceptive counseling and provision at a time when Americans’ access to abortion is becoming increasingly limited. She also notes that the findings have important implications for clinicians who care for patients who can become pregnant, as pregnancy, particularly if unintended, can be  associated with adverse patient outcomes. These risks are particularly important for patients with underlying medical conditions. Dr. Laine also encourages internists to assume responsibility for contraception counseling and provision when delivering healthcare to patients who may become pregnant.

Media contacts: For an embargoed PDF or to speak with editorialist Christine Laine, MD, MPH, please contact Angela Collom at acollm@acponline.org. To speak with the lead author, Heidi D. Nelson, MD, MPH, please email Ashannti Hill at Ashannti.K.Hill@kp.org.

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2.  Cause of “long COVID” remains unclear even after comprehensive patient evaluations

Abstract: https://www.acpjournals.org/doi/10.7326/M21-4905  

Editorial abstract: https://www.acpjournals.org/doi/10.7326/M22-1492 

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A cohort study found that patients with mild or moderate COVID-19 may still experience a high burden of persistent symptoms after infection, but the causes remain unclear. The findings are published in Annals of Internal Medicine.

Many people report persistent symptoms after recovery from acute COVID-19. The causes of these persistent symptoms, a condition often referred to as “long COVID,” are still unclear.

Researchers from the National Institutes of Health (NIH) studied 189 patients who were at least 6 weeks out from laboratory-documented COVID-19 and 120 control patients to characterize medical sequelae and persistent symptoms after recovery from COVID-19. They found that 55% of previously infected patients experienced persistent symptoms. However, the authors caution that it is probable that their study overestimates the true prevalence of long COVID as individuals with persistent post-COVID-19 symptoms were likely more motivated to enroll in the study. The most common persistent symptoms noted in this study were fatigue, labored breathing, chest discomfort, parosmia, headache, insomnia, memory impairment, anxiety, and concentration impairment after infection. Abnormal findings on physical examination and laboratory evaluation were uncommon and occurred with similar frequency in the COVID-19 and control groups. The authors also report that they did not find evidence of persistent viral infection or damage to tissue and organs in patients with persistent symptoms. However, those patients self-reported worsened physical and mental health and lower quality of life than either control participants or patients with COVID-19 but without persistent symptoms. According to the authors, the constellation of subjective symptoms in the absence of objective abnormalities on diagnostic evaluation resembles what has been described with other illnesses, including chronic fatigue syndrome, post-infection syndromes described after resolution of certain viral and bacterial infections, and mental health disorders such as depression and anxiety.

Media contacts: For an embargoed PDF or to speak with someone from ACP, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, Michael C. Sneller, MD, please contact the NIAID News & Science Writing Branch at NIAIDNews@niaid.nih.gov. 

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3. SGLT-2i demonstrate a lower risk for heart failure compared to metformin in patients with type 2 diabetes

Abstract: https://www.acpjournals.org/doi/10.7326/M22-4012      

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A population-based cohort study found that patients with type 2 diabetes receiving first-line sodium–glucose cotransporter-2 inhibitors (SGLT-2i) have a similar risk of stroke, myocardial infarction, and all-cause mortality but a lower risk of heart failure compared to patients receiving metformin. The authors also report that the risk for adverse events was similar except for an increased risk for genital infections among patients taking SGLT-2i. The findings are published in Annals of Internal Medicine.

SGLT-2i has demonstrated benefit in reducing risk of hospitalization in patients with cardiovascular disease (CVD). It has previously been recommended as a second-line treatment, but has more recently been recommended as a first-line treatment for patients with type 2 diabetes and CVD. Alternatively, metformin indicated reduced risk for myocardial infarction and all-cause mortality in a subgroup of patients in the U.K Prospective Diabetes Study. Previous nonrandomized studies have mostly focused on the use of SGLT-2i as a second-line treatment, or had the potential to include non-first-line users.

Researchers from Brigham and Women's Hospital and Harvard Medical School studied 8,613 patients initiating SGLT-2i matched to 17,226 patients initiating metformin as first-line type 2 diabetes treatment to assess cardiovascular outcomes between the two groups. The authors found that patients initiating SGLT-2i showed a lower risk for hospitalization for heart failure, a numerically lower risk for myocardial infarction, and similar risk for stroke, all-cause mortality, and myocardial infarction/stroke/hospitalization for heart failure/all-cause mortality compared with metformin. Patients initiating SGLT-2i had a higher risk for genital infections but showed similar risk for adverse events as patients receiving metformin. The authors note that while their findings may support the use of SGLT-2i as first-line type 2 diabetes treatment of cardiovascular outcomes, further research is warranted to establish more robust evidence.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, HoJin Shin, BPharm, PhD, please email Sarah Sentman at SarahA_Sentman@DFCI.HARVARD.EDU.    

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4. Accelerated approval costs Medicare billions each year, represents an opportunity to incentivize completion of confirmatory trials

Abstract: https://www.acpjournals.org/doi/10.7326/M22-4442      

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A new cross-sectional analysis found that the US Food and Drug Administration’s (FDA) accelerated approval pathway has led to Medicare spending $1.8 billion in 2019 on drugs without confirmed clinical benefit. Under the status quo, drug companies have little financial incentive to complete confirmatory trials that confirm a drug’s meaningful clinical benefit. The significant spending by Medicare presents an opportunity to provide a financial incentive for drug companies to complete their confirmatory trials thereby demonstrating a drug’s clinical benefit. The analysis is published in Annals of Internal Medicine.

Accelerated approval was created by the FDA in 1992 to give patients with life-threatening illnesses faster access to medications with likely clinical benefit while confirmatory trials are underway. While it was intended to fill urgent needs for the critically ill, the number of drugs in Medicare’s accelerated approval program is growing. Between 2017 and 2020, a total of 87 drugs received accelerated approval by Medicare, accounting for 34% of all drugs that received accelerated approvals by Medicare since 1992.

Researchers from Johns Hopkins Bloomberg School of Public Health evaluated 45 drugs associated with 69 accelerated approval uses, or indications, but still lacked full FDA approval in 2019. The authors used data from a 20% nationally representative sample of Medicare fee-for-service claims in 2019 to determine Medicare's spending on drugs with accelerated approval without confirmed benefit. The authors found that Medicare beneficiaries used 36 of these drugs across 55 accelerated approved indications which cost $1.2 billion in Medicare fee-for-service spending. They also report that 7 of these accelerated approval drugs were withdrawn from the market by manufacturers in 2020 or 2021, representing $187 million in 2019 Medicare spending.

The authors note that drugs approved under accelerated approval require confirmatory trials to confirm meaningful clinical benefit. These trials often take years to complete and drug companies have little incentive to complete the trials since accelerated approval provides a drug access to the Medicare market. The authors suggest that Medicare should change payment rates to incentivize faster confirmatory trials.

Media contacts: For an embargoed PDF or to speak with corresponding author, Jeromie Ballreich PhD, MHS, please contact Angela Collom at acollom@acponline.org.