Saturday, December 19, 2020

New guideline for managing acute pain from musculoskeletal injuries

In a 2017 practice guideline based on a systematic review of noninvasive treatments, the American College of Physicians (ACP) recommended superficial heat, massage, acupuncture, and spinal manipulation as initial treatment options for patients with acute low back pain, in addition to a nonsteroidal anti-inflammatory drug (NSAID) or skeletal muscle relaxant if desired. But is a similar approach effective for treating pain from acute musculoskeletal injuries not involving the lower back? To answer this question, the American Academy of Family Physicians (AAFP) joined the ACP in developing another practice guideline on management of acute pain from non-low back, musculoskeletal injuries in adults, a synopsis of which appeared in Practice Guidelines in the December 1 issue of American Family Physician. These are some key practice points from the guideline:

• Topical NSAIDs are the most effective intervention for acute musculoskeletal pain other than low back pain.

• Although oral NSAIDs and acetaminophen are effective for acute pain relief, combining them does not improve effectiveness.

• Although moderately effective for pain relief, opioids increase gastrointestinal and neurologic adverse effects and lead to long-term use in 6% of people treated.

• Acupressure and transcutaneous electrical nerve stimulation techniques are effective nonpharmacologic options for acute pain.

In an accompanying editorial, Dr. David O'Gurek and I, who represented the AAFP on the guideline committee, and Dr. Melanie Bird, AAFP Clinical and Health Policies Manager, discussed some of the guideline's highlights and limitations. A systematic review and network meta-analysis of randomized, controlled trials provided direct and indirect comparisons of various treatment options on outcomes that included pain relief and physical functioning, symptom relief, treatment satisfaction, and adverse events.

Topical NSAIDs improved all efficacy outcomes with minimal adverse effects, while oral NSAIDs and acetaminophen improved fewer outcomes and were more likely to cause adverse events. We suggested against using opioids, including tramadol, for acute musculoskeletal injury pain due to their poor adverse effect profile and the risk of prolonged use, ranging from 6% in low-risk to 27% in high-risk populations. We also noted that "equitable coverage and affordability of first-line treatments" are essential to reduce well-known racial and socioeconomic disparities in pain management; for example, though a topical NSAID is now available over-the-counter, it costs significantly more than oral NSAIDs and acetaminophen and may not be covered by health insurance plans.

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This post first appeared on the AFP Community Blog.

Sunday, December 13, 2020

Long-term benefits of newborn metabolic screening

State-mandated screening at birth for rare, serious medical conditions occurs in 4 to 5 million newborns and detects 5,000 to 6,000 affected infants each year. A 2017 American Family Physician article reviewed various conditions that are targeted by newborn screening: amino acid disorders, fatty acid oxidation disorders, organic acid disorders, hemoglobinopathies, endocrine disorders, and miscellaneous diseases (including congenital hearing loss and critical congenital heart defects). With a combined incidence of 1 out of every 1,500 births, inborn errors of metabolism are the most common conditions detected by newborn screening.

After tandem mass spectrometry made it possible to test for many conditions using a single blood sample, the federal Health Resources and Services Administration's Maternal and Child Health Bureau commissioned the American College of Medical Genetics (ACMG) to create a uniform list of conditions for newborn screening panels in 2005. However, the ACMG's recommended core panel of 29 conditions was criticized by the U.S. Preventive Services Task Force (USPSTF) for not taking an evidence-based approach. In a position paper, the USPSTF noted that the ability to detect a condition with high diagnostic accuracy was insufficient to include it in the panel:

A newborn screening program is not just a panel of screening tests. ... It is also parental education, follow-up, diagnosis, treatment and management, and program evaluation, and all of the various parts of the system must be in place and working well to realize the benefits of screening. ... Moreover, a newborn screening panel should be expanded only if the newborn screening program is fully prepared to make all the components of the complex system available for the new disorders. Expansion would be costly and might not be the best use of scarce health care resources, given the many other unmet child health needs.

Reinforcing the USPSTF's concerns, an analysis by the Centers for Disease Control and Prevention projected that if all 50 states expanded their newborn screening panels to align fully with the ACMG recommendations, "although such an expansion would have increased the number of children identified by 32% (from 4,370 to 6,439), these children would have had many rare disorders that require local or regional capacity to deliver expertise in screening, diagnosis, and management." A cross-sectional survey of Ontario primary care clinicians found that family physicians had limited knowledge of conditions identified by newborn screening tests, and many were not comfortable leading detailed discussions of abnormal results with parents or guardians.

The U.S. Secretary of Health and Human Services' Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC) subsequently developed a more rigorous framework to evaluate conditions nominated as additions to the uniform screening panel, requiring an independent systematic evidence review of key questions based on an analytic framework similar to those used for USPSTF reviews. In a separate document, the SACHDNC outlined questions for newborn screening long-term follow-up data systems to answer to make sure that programs achieve their goals of improved outcomes for children and families.

An observational study published last month in Pediatrics reported the clinical outcomes of 306 individuals with inherited metabolic diseases identified by a university hospital laboratory performing Germany's newborn screening panel from 1999 to 2016. The German national panel is less extensive than the ACMG's, consisting of 2 endocrine and 12 inherited metabolic diseases, and the nearly 2 million newborns screened during the study period represented 15 percent of Germany's live births. 28 individuals presented with metabolic symptoms prior to newborn screening results being available; the rest were successfully enrolled in specialized metabolic/nutritional therapy while still asymptomatic. Although nearly 1 in 4 individuals eventually developed irreversible disease-specific clinical signs, 88% had normal cognitive outcomes, and more than 95% showed normal development and attended regular kindergarten and primary schools.

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This post first appeared on the AFP Community Blog.

Sunday, December 6, 2020

To beat COVID-19, focus on vaccine distribution and building trust

Even as the numbers of persons hospitalized for and dying daily from COVID-19 are surpassing all-time highs, America is suffering from pandemic fatigue. Although millions have curtailed social gatherings or changed holiday travel plans, exhortations by public officials, school closings, and renewed stay-at-home orders don't seem to be slowing the spread of the virus in most states. In September, I warned that a vaccine against SARS-CoV-2 was unlikely to be a "magic bullet" for the pandemic unless it had very high efficacy and population uptake well beyond the historical standard set by annual influenza vaccines. As it turns out, though, the first two messenger RNA vaccines developed by Pfizer/BioNTech and Moderna/National Institutes of Health appear to be highly efficacious (despite these important caveats) in preventing mild to severe COVID-19 infections, and both could receive an emergency use authorization from the U.S. Food and Drug Administration to begin administering the first doses within the next two weeks. Historians of medicine will likely chronicle the "warp speed" development of these vaccines as an amazing achievement given the intense political and humanitarian pressures involved. But in terms of ending the pandemic, that may turn out to be the easy part.

Physicians like me have some sayings about other strongly recommended medical interventions. "The best screening test for colorectal cancer is the one that gets done." "The best blood pressure medication is the one the patient can afford to buy and is able to take every day." Conversely, I agree with the title of a recent Washington Post article by the director of the Yale Institute of Global Health: "Rapid development of a [coronavirus] vaccine won’t help much if people refuse to take it." On one hand, I don't place a great deal of stock in (and feel that there's been entirely too much journalistic hand-wringing about) surveys that found that sizeable percentages of Americans were reluctant or unwilling to receive a coronavirus vaccine; nearly all were polled when no viable vaccine candidate existed, and it's unsurprising and, frankly rational, that people would have reservations about being injected with a completely theoretical foreign substance.

Since it will be at least several months before enough vaccine doses are available for the entire population, the first wave will be administered to health care workers and residents of long-term care facilities, followed by essential workers and adults at high risk due to age or other medical conditions. I suspect that the vast majority of persons in these categories will choose to receive a vaccine. Personally, it will be a great relief to have protection against becoming severely ill due to an occupational exposure to COVID-19, and potentially (if the vaccine prevents asymptomatic viral transmission, which is uncertain but probable) protecting my spouse and children until they are eligible to receive the vaccine themselves.

The big question is: will other Americans who don't consider themselves to be at "high risk" for severe COVID-19, who have suspicions about the motivations of the federal government and/or pharmaceutical companies, or are concerned about the safety of the vaccine (whose long-term side effects are obviously not known, though it's hard to imagine that they could be worse than what thousands of COVID-19 "long-haulers" are already suffering) accept vaccination in high enough numbers to provide herd immunity to the population and halt the pandemic? And will our inefficient, fragmented public health and health care systems be up to the task of delivering a vaccine to everyone who wants it?

A Commonwealth Fund report found that states with higher COVID-19 case counts and larger percentages of Black, Latino, and American Indian populations (who have a disproportionately higher risk for hospitalization and death than Asian Americans and non-Hispanic Whites) have been less successful than other states in administering annual influenza and H1N1 vaccines, and nearly all states report historically lower vaccine uptake in the same racial and ethnic groups that are at highest risk. A modeling study in Health Affairs suggested that problems with implementation of a national vaccination program - how quickly vaccine doses can be manufactured and deployed, for example - could easily blunt the population benefits of a vaccine that is highly effective in individuals:

The benefits of a vaccine will decline substantially in the event of manufacturing or deployment delays, significant vaccine hesitancy, or greater epidemic severity. Our findings demonstrate the urgent need for health officials to invest greater financial resources and attention to vaccine production and distribution programs, to redouble efforts to promote public confidence in COVID-19 vaccines, and to encourage continued adherence to other mitigation approaches, even after a vaccine becomes available.

The stakes could not be higher, and there is no more time to waste. The vaccine scientists have done their job, and we owe them an enormous debt of gratitude. Now it's time for medical professionals and their allies (you, who are reading this blog post) to spread the word that being vaccinated against COVID-19 when your turn comes is not only good for your own health and personal safety, but benefits our communities, our states, and our country. There is no Democratic vaccine or Republican vaccine, and who you happened to vote for President no longer matters. We are all in the fight against this virus together, as we have always been. As Benjamin Franklin is thought to have said at the signing of America's Declaration of Independence, "We must all hang together, or, most assuredly, we shall all hang separately."

Saturday, November 21, 2020

Does COVID-19 harm mental health through stress, enforced isolation, or the virus itself?

Eight months ago, during the first wave of the pandemic, my American Family Physician editor colleague Dr. Jennifer Middleton discussed World Health Organization and Centers for Disease Control and Prevention (CDC)-recommended strategies and resources for optimizing mental health in health care workers, patients, and children. A CDC representative national survey conducted in late June found a strikingly high prevalence of symptoms of anxiety or depressive disorder (30.9%), trauma- and stressor-related disorder (26.3%) and new or increased substance use (13.3%). By comparison, a 2019 survey found that only 8.1% and 6.5% of people had symptoms of anxiety or depression, respectively. 1 in 10 respondents to this year's survey also reported having seriously considered suicide in the preceding 30 days, with disproportionately higher suicidality in younger adults (age 18-24 years), racial and ethnic minorities, essential workers, and unpaid adult caregivers.

In a recent commentary, Dr. Christine Moutier from the American Foundation for Suicide Prevention recommended several COVID-19-specific suicide prevention strategies that fuse clinical, health system, and policy interventions: reduce risk for people with mental illness or addiction; increase social connectedness; address risk at the moment of crisis; reduce access to lethal means; address COVID-19 increases in alcohol consumption and drug overdoses; mitigate financial strain; address domestic violence and unsafe environments; and prevent unsafe media and entertainment messaging on suicide.

The rise in anxiety, depression, stress, and suicidality coincided with the widespread conversion of office-based visits for behavioral and psychiatric conditions to telehealth, which may have restricted access to mental health care for existing and new patients. As three psychiatrists observed in a JAMA Viewpoint:

Patients with psychiatric disorders are particularly vulnerable to COVID-19 due to high rates of overweight, tobacco smoking, medical comorbidities, and poor self-care. ... Daily news of large-scale COVID-19–related disease and death in the community over months or years is almost certain to elevate psychiatric burden in the population. As such, the pattern of stress resembles that experienced by refugees or others exposed to chronic violence. ... A sustained increase in demand for psychiatric services may well exceed the existing capacity of the system over time and may last for years, depending on the course the pandemic takes.

Persons with prior psychiatric diagnoses may be at higher risk of death from COVID-19 infection. A cohort study of 1685 patients hospitalized with COVID-19 from February through April found that after controlling for demographics, medical comorbidities, and hospital location, patients with a psychiatric disorder were 1.5 times as likely to die as those with no psychiatric diagnosis. Citing a kinship network study that suggested that each COVID-19 death in the U.S. leaves nine bereaved close family members, some have suggested that primary care physicians screen relatives of persons who die from COVID-19 for symptoms of depression, prolonged grief, or post-traumatic stress disorder and provide evidence-based interventions if needed.

On the other hand, a diagnosis of COVID-19 may increase the risk for developing a mental health disorder. A retrospective cohort study that utilized electronic health record data from more than 62,000 U.S. patients between January 20 and August 1 found that COVID-19 survivors were more likely to have a first psychiatric diagnosis, a new psychiatric diagnosis, or a relapse of a previously stable diagnosis within 14 to 90 days than six other unrelated health events. However, this study design could not determine if these additional diagnoses were preexisting and unrecognized prior to COVID-19 infection or a direct consequence of the infection or medical interventions (including isolation at home or in the hospital).

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This post first appeared on the AFP Community Blog.

Sunday, November 15, 2020

Incarceration, restorative justice and health

Of the barrage of discouraging pandemic statistics - the quarter of a million U.S. deaths to date, the 93 daily new cases per 100,000 residents and current 20+ percent test positivity rate in my adopted state of Utah - one of the most striking is that of the 14 persons who died from COVID-19 in Texas county jails from April to September, 11 were awaiting trial and had not been convicted of a crime. A recent report of COVID-19 deaths in Texas correctional institutions from the University of Texas at Austin found that jail deaths represented only 6 percent of the 231 overall deaths during incarceration (including prison staff). Those serving time for a criminal conviction were, clearly, not sentenced to death by suffocation from a deadly virus. Since Texas accounts for approximately 9 percent of the U.S. population, my conservative estimate is that at least 100 Americans, mostly persons of color, have already died from COVID-19 while detained in jails awaiting trials, unable to physically distance or otherwise protect themselves.

A few years ago, as a member of the American Academy of Family Physicians' Commission on the Health of the Public and Science, I co-authored a position paper that articulated a family medicine perspective on the negative effects of mass incarceration on the health of justice-involved persons, their families, and their communities. We found that in 2016, the U.S. corrections system supervised 6.6 million people (1 in every 50 residents) in jails, prisons, or on probation or parole - the highest incarceration rate in the world and a nearly fivefold increase since 1978. Given these figures, a basic understanding of the justice system has become essential not only for family physicians and internists, but also pediatricians, who are increasingly likely to encounter justice-involved youth. The "Patients, Populations, and Policy" course that I co-direct at Georgetown includes a mandatory screening of the documentary 13th, which argues that a loophole in the 13th Amendment to the U.S. Constitution, which abolished slavery and involuntary servitude for African Americans "except as a punishment for crime," enabled institutionalized racism in policing and criminal sentencing that persists to this day.

This background explains why many progressive Americans are not celebrating the recent election of Senator Kamala Harris, a former prosecutor, to the office of Vice President of the United States. As the current Vice President pointed out during their October 7 debate, during Harris's tenure as California Attorney General, Black persons were much more likely to be prosecuted for minor drug offenses and were disproportionately incarcerated compared to their share of the general population. In a New York Times Magazine article, former felon Reginald Betts reflected on his mixed feelings about prosecutors and mass incarceration. Betts, who was convicted of carjacking and armed robbery and imprisoned from age 16 to 24, was shocked to learn after his release that his mother had been raped at gunpoint just weeks after his arrest. Naturally, even though some of the men with whom he served time were guilty of similar offenses, Betts "thought he [the rapist] should spend the rest of his years staring at the pockmarked walls of prison cells that I knew so well."

Betts observed that most Americans who oppose mass incarceration today imagine that most of the prison population is serving time for nonviolent drug-related crimes. Not so: "You could release everyone from prison who currently has a drug offense and the United States would still outpace nearly every other country when it comes to incarceration." What, then, is the responsibility of progressive prosecutors who, like Vice President-elect Harris, desire to address inequities in the justice system that result not only from unjust policing, but penalties for the crimes themselves? Betts responded:

The prosecutor’s job, unlike the defense attorney’s or judge’s, is to do justice. What does that mean when you are asked by some to dole out retribution measured in years served, but blamed by others for the damage incarceration can do? The outrage at this country’s criminal-justice system is loud today, but it hasn’t led us to develop better ways of confronting my mother’s world from nearly a quarter-century ago: weekends visiting her son in a prison in Virginia; weekdays attending the trial of the man who sexually assaulted her.

Ideally, our criminal justice system should serve two purposes: punishment and rehabilitation. That three-quarters of persons released from state prisons in 2005 were arrested again within 5 years suggests that the system fails miserably at the latter, and if spending time behind bars (punishment) is supposed to deter criminals from committing crimes again, failing at the former as well. As Betts wrote:

It always returns to this for me — who should be in prison, and for how long? I know that American prisons do little to address violence. If anything, they exacerbate it. If my friends walk out of prison changed from the boys who walked in, it will be because they’ve fought with the system — with themselves and sometimes with the men around them — to be different. 

Through the mystery novels of the late Tony Hillerman, I am superficially familiar with the Navajo Nation's concept of "restorative justice", described in a 1994 New Mexico Law Review article by former Navajo Nation Chief Justice Robert Yazzie. Yazzie characterized traditional American justice as an "adversarial" process administered by strangers:

Law, in Anglo definitions and practice, is written rules which are enforced by authority figures. It is man-made. Its essence is power and force. The legislatures, courts, or administrative agencies who make the rules are made up of strangers to the actual problems or conflicts which prompted their development. When the rules are applied to people in conflict, other strangers stand in judgment and police and prisons serve to enforce those judgments.

In contrast, traditional Navajo peacemaking shuns a justice system based on "social control" in favor of pragmatic group problem-solving about "the means to live successfully." In a related article, Yazzie wrote:

Navajo peacemaking is about the effects of what happened. Who got hurt? What do they feel about it? What can be done to repair the harm? ... In Navajo peacemaking, offenders are brought in to a session involving the person accused of an offense and the person who suffered from it, along with the “tag-along” victims of the crime, namely the relatives of the accused and of the person hurt by the accused.  The sessions are moderated by a community leader called a “peacemaker.” The action is put on the table. People talk about what happened and how they feel about it. A harmful act is “something that gets in the way of living your life,” and Navajo peacemaking deals with such an act by identifying it, talking about it, and devising a plan to deal with it.

The recent execution of a Navajo man on federal death row for the carjacking-murder of two Navajos in 2001, despite the opposition of the Navajo Nation, highlighted the potential advantages of incorporating restorative justice into state and federal criminal justice systems. Although it's possible that the victims' loved ones gained some satisfaction from the execution (albeit 19 years after the murders), it's hard to argue that any harm was "repaired" or harmony restored by this second violent act. (Note: as a practicing Catholic, I believe that the death penalty is wrong regardless of the crime.) I don't believe that prisons should be abolished, any more than I believe that police departments should be defunded. But if the U.S. is going to continue to pour hundreds of billions of dollars into incarceration every year, a large chunk of those dollars ought to be devoted to peacemaking - making the offender whole and less likely to offend again - rather than punishment.

Sunday, November 8, 2020

Mobile heart monitoring: advantages and limitations

During the first wave of the pandemic, when hydroxychloroquine was still thought to be an effective treatment for hospitalized patients with COVID-19 (subsequent studies have shown otherwise), some U.S. hospitals used personal electrocardiogram (ECG) devices to monitor these patients for drug-induced QT interval prolongation to conserve personal protective equipment and telemetry monitors. Such devices were already being used by patients with known cardiac conditions to monitor their heart rhythms in out-of-office settings.

As I discussed in a previous post, wearable devices such as the Apple Watch are also being studied to detect atrial fibrillation in asymptomatic primary care patients. In a 2019 study of more than 400,000 U.S. Apple Watch wearers with no self-reported history of atrial fibrillation, about 1 in 200 individuals received an irregular pulse notification and were scheduled for a telemedicine visit with a clinician to confirm study eligibility and triage those with urgent symptoms to the emergency department. Participants without urgent symptoms were mailed an ECG patch to wear for up to 7 days and then mail back to the study center.

Of the 450 participants who returned an ECG patch, 34% were confirmed to have atrial fibrillation, with a higher diagnostic yield in persons age 65 years or older. Of the 86 patients whose watches generated irregular pulse notifications when they were wearing the ECG patch, the positive predictive value for atrial fibrillation was 84%. In a survey completed at 90 days by patients who received an irregular pulse notification, 28% reported being prescribed a new medication, 33% were referred to a specialist, and 36% were recommended to have additional testing.

In the November 1 issue of American Family Physician, Dr. Madhavi Singh and colleagues reviewed the diagnostic test features of KardiaMobile, a $99 single-lead device that connects wirelessly to a smartphone app to generate an ECG tracing with automated interpretation. In studies of patients with known or suspected arrhythmias, KardiaMobile had greater than 90% sensitivity and specificity for atrial fibrillation or atrial flutter compared to a standard 12-lead ECG. However, no studies have compared its accuracy with a Holter or event monitor, and effects on patient outcomes are uncertain, particularly in populations at low risk for arrhythmias. (In 2018, the U.S. Preventive Services Task Force found insufficient evidence to assess the balance of benefits and harms of screening for atrial fibrillation, which has several potential downsides.) The authors concluded (and I agree) that similar to the Apple Watch, "further studies are needed before KardiaMobile can be recommended for use in seemingly healthy patients."

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This post first appeared on the AFP Community Blog.