2 Minute Medicine Rewind March 22, 2021

Objective sleep efficiency predicts cardiovascular disease in a community population: The Sleep Heart Health Study

1. In a large, community-based cohort, poor sleep efficiency and wake after sleep onset were associated with major adverse cardiovascular events.

Evidence Rating Level: 2 (Good)

Sleep efficiency (SE) is defined as the ratio of time spent sleeping to time spent in bed. It is considered to be an objective measure of the quality of sleep, with an SE of ≥ 85% considered to be efficient sleep, associated with higher energy and elevated mood. This study sought to evaluate the relationship between cardiovascular disease and SE objectively measured with polysomnography. It made use of data from the Sleep Heart Health Study, a community-based, prospective cohort study investigating the cardiovascular ramifications of sleep-disordered breathing. 3,810 participants (mean [SD] age = 63.2 [11.0] years, 45% male) underwent in-home overnight polysomnography. The primary composite outcome was the first occurrence of a major adverse cardiovascular event, defined as cardiovascular death, CHF, MI, and stroke. Participants were sorted into four categories of SE: ≥ 90%, 85% to 89.9%, 80% to 84.9%, and < 80%, which corresponded with 29.5%, 24.5%, 17.6%, and 28.4% of participants, respectively. Those with SE < 80% were more likely to be older and be male. After a mean follow-up of 10.9±2.8 years, 474 cases of the primary cardiovascular outcome occurred, with the highest incidence among participants with SE < 80% (17.5% vs. 13.2% vs. 10.5% vs. 7.3%; p < 0.001) compared with those with 80% to 84.9%, 85% to 89.9%, and ≥ 90%, respectively. Furthermore, after adjusting for variables like age, sex, BMI, smoking status, and comorbidities, SE < 80% was found to be an independent predictor of primary composite cardiovascular outcomes (HR 1.338, 95% CI 1.025 to 1.745, p = 0.032). Finally, wake after sleep onset of fourth quartile (> 78.0 minutes) was associated with the primary composite cardiovascular outcomes (HR 1.436, 95% CI 1.066 to 1.934, p = 0.017). Overall, this study suggests that poor SE as measured objectively by polysomnography is associated with incident cardiovascular disease and that such measurements may have a role in predicting future outcomes.

Reinfection rates among patients who previously tested positive for COVID-19: a Retrospective cohort study

1. Among a large U.S. cohort, previous infection with SARS-CoV-2 appears to confer high levels of immunity against reinfection for at least 8 months.

Evidence Level Rating: 2 (Good)

As of early March 2021, SARS-CoV-2 has infected nearly 120 million individuals worldwide. The subsequent duration of immunity to reinfection is unknown; infection with common seasonal coronavirus does not tend to confer lasting immunity. Vaccination against SARS-CoV-2 is increasing, but due to shortages, nearly all countries have implemented prioritization schemes. Having a more robust understanding of immunity after confirmed infection has the potential to affect these schemes by delaying vaccination for those with likely immunity to allow access for the more vulnerable. This large cohort study included 612,611 tests from 386,336 individuals (mean [SD] age = 51.4 [22.4] years, 54.5% female) across one healthcare system in both Ohio and Florida, with a 9.9% overall positivity rate. Initial infection status was based on PCR testing performed prior to 30 August 2020. 150,325 patients had tests performed prior to this date, with 8,845 testing positive. After at least 90 days, 1,278 of these previously positive patients were retested, with 62 reviewed for reinfection. 31 of these reinfected patients were symptomatic, and 18 were hospitalized within 30 days of the positive test. The average time to reinfection was 138.9±46.3 days. Among those who initially tested negative, 27.9% (39,487/141,480) were retested, with 5,449 testing positive. Overall, the protection of prior infection against reinfection was determined to be 81.8% (95% CI 76.6% to 85.8%), while against symptomatic infection it was 84.5% (95% CI 77.9% to 89.1%). Protection against reinfection was lowest in months 4 to 5 and increased for up to 8 months after initial infection. There are numerous limitations of this study, such as including only tests from one healthcare system, the possibility of persistent viral shedding from the initial infection past 90 days, and unknown behavioral changes following initial infection affecting future exposures. However, it appears that previous SARS-CoV-2 infection confers high levels of protection against reinfection for at least 8 months, suggesting that patients previously infected may defer vaccination to allow for inoculation of more vulnerable individuals.

Effect of osteopathic manipulative treatment vs sham treatment on activity limitations in patients with nonspecific subacute and chronic low back pain: A randomized clinical trial

1. Among patients with nonspecific low back pain, osteopathic manipulative treatment compared with a sham treatment modestly reduces activity limitations associated with back pain at 3 months but has no impact on pain or absenteeism at work.

Evidence Level Rating: 1 (Excellent)

Nonspecific low back pain (LBP) is associated with substantial morbidity worldwide. Osteopathic manipulative treatment (OMT) is frequently offered as therapy, but it has never been compared with sham OMT in a randomized setting. This study is a parallel-group, randomized, single-blind, sham-controlled trial comparing the efficacy of standard OMT with sham OMT for reducing LBP-specific activity limitations at 3 months among patients with nonspecific subacute or chronic LBP. The primary efficacy outcome was the mean reduction from baseline in LBP-specific activity limitations at 3 months as measured by the Quebec Back Pain Disability Index (QBPDI), with scores ranging from 0 (no limitations) to 100 (maximum limitations). In all, 197 patients (mean [SD] age = 48.3 [11.9] years, 58.9% female) were included in the intervention cohort and 197 (mean [SD] age = 47.5 [10.6] years, 60.4% female) in the sham cohort. The mean QBPDI scores for the intervention cohort were 31.5±14.1 at baseline and 25.3±15.3 at 3 months, while in the sham cohort they were 27.2±14.8 at baseline and 26.1±15.1 at 3 months. This corresponds to a mean reduction in LBP-specific activity limitations of -4.7 in the intervention cohort and -1.3 in the sham cohort, with a mean difference of -3.4 in favor of the OMT intervention (95% CI -6.0 to -0.7, p = 0.01). However, among secondary outcomes measured, there was no significant difference between the two cohorts with regards to pain, health-related quality of life (HRQOL), work absenteeism, or use of analgesics and NSAIDs. As such, despite there being a difference favoring the OMT intervention in terms of the reduction in activity limitations with LBP, the clinical relevance of this modest reduction is questionable, given the lack of difference observed in secondary outcomes like pain and absenteeism to work.

Association of co-exposure of antenatal steroid and prophylactic Indomethacin with spontaneous intestinal perforation

1. Among preterm and extremely low birth weight neonates, the co-exposure to antenatal steroids and postnatal indomethacin was associated with an increased risk of spontaneous intestinal perforation.

Evidence Level Rating: 2 (Good)

Both antenatal steroids (ANS) and postnatal indomethacin (PI) are utilized in neonatology to reduce the morbidity and mortality associated with intraventricular hemorrhage (IVH) as well as reduce the incidence of severe IVH (sIVH) and patent ductus arteriosus (PDA), respectively, among preterm and extremely low weight neonates. However, there is a concern that exposure to both drugs increases the risk of spontaneous intestinal perforation (SIP). Both sIVH and SIP are quite dangerous. As such, the objective of this study was to evaluate the association between ANS and PI co-exposure and the incidence of SIP among neonates of < 26 weeks gestational age or < 750 g birth weight. 4,720 infants were included for analysis, 87% of whom received ANS and 22.1% of whom received PI. The overall incidence of PI was 4.2%. Among those exposed to ANS, infants who also received PI had higher odds of SIP (aOR 1.61, 95% CI 1.14 to 2.28) compared with no exposure to PI. In a subgroup analysis, recent ANS exposure (≤ 7 days before birth) with PI co-exposure was associated with significantly higher odds of SIP (aOR 1.67, 95% CI 1.15 to 2.43) while latent ANS exposure (> 7 days before delivery) with PI co-exposure was not (aOR 1.24, 95% CI 0.48 to 3.21). Among those receiving latent ANS, there were no differences in the risk of SIP, sIVH, or mortality regardless of PI exposure. Finally, among those not exposed to ANS, receipt of PI was associated with a lower mortality (aOR 0.45, 95% CI 0.28 to 0.73) compared with no receipt of PI. In all, this study suggests that co-exposure of ANS and PI – especially if ANS was received within 7 days before birth – was associated with higher odds of SIP among neonates born at < 26 weeks gestational age or < 750 g birth weight. These data may support the development of personalized approaches for the administration of PI based on whether ANS was received and when.

Early enteral feeding versus traditional feeding in neonatal congenital gastrointestinal malformation undergoing intestinal anastomosis: A randomized multicenter controlled trial of an Enhanced Recovery After Surgery (ERAS) component

1. Among neonates with congenital gastrointestinal malformations requiring surgery, early enteral feeding is safe and well-tolerated when compared with traditional postoperative nutrition strategies.

Evidence Level Rating: 1 (Excellent)

Congenital gastrointestinal malformations – such as duodenal obstruction, jejunoileal atresia, and meconium ileus – among neonates are often treated with primary intestinal anastomosis. Historically, patients undergoing such surgeries were kept NPO for an extended period of time following the operation; however, there has been a transition in recent years towards early enteral feeding (EEN), which has been shown to reduce not only postoperative morbidity and mortality but also length of stay in adults undergoing gastrointestinal surgery. This study is a randomized clinical trial evaluating the safety and efficacy of EEN among neonates with congenital gastrointestinal malformations undergoing intestinal anastomosis. The primary outcomes were time to full feeds and length of postoperative stay (LOPS). 78 infants were randomized to the EEN cohort – in which enteral feeds were started within 48 hours via nasogastric tube (NGT) before transitioning to oral feeds upon resolution of bilious gastric residual or drainage – and 78 infants to the control cohort – in which neonates remained NPO with decompressive NGT until resolution of bilious gastric residual or drainage before starting oral feeds. The most common malformation was jejunoileal atresia, followed by duodenal atresia and annular pancreas. In the EEN cohort, the mean time to full feeds and LOPS were 15.0 (9.8 to 22.8) and 17.6 (12.0 to 29.8) days, respectively, which did not differ significantly (p > 0.05) from the control cohorts, where the mean time to full feeds and LOPS were 18.0 (12.0 to 24.0) and 20.0 (15.0 to 30.3) days, respectively. Furthermore, there was no difference between the two cohorts with respect to anastomotic leakage, peritonitis, gastrointestinal hemorrhage, necrotizing enterocolitis, or sepsis. EEN was well-tolerated, with no significant difference in the incidence of abdominal distention, repeated vomiting, repeated decompressive NGT, or repeated NPO. In all, this study demonstrated that among neonates with congenital gastrointestinal malformations requiring surgery, EEN is safe and well-tolerated.

Image: PD

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