Friday, February 3, 2023

Masking and Viral Illnesses

 To date, widespread masking has been recommended by a number of organizations to reduce spread and personal infection risk from viruses like COVID 19.  The American Academy of Pediatrics, validated this recommendation by advising all children 2 and up to wear masks.  Yet quality data supporting any of these recommendations was never available.  This Cochrane Review collates the available quality studies and concludes neither cloth , surgical or even N95 masks provide any significant protection to the wearer in these settings.  The recommendation for public masking, while well intentioned, was wrong and should be abandoned immediately.


Viral epidemics or pandemics of acute respiratory infections (ARIs) pose a global threat. Examples are influenza (H1N1) caused by the H1N1pdm09 virus in 2009, severe acute respiratory syndrome (SARS) in 2003, and coronavirus disease 2019 (COVID‐19) caused by SARS‐CoV‐2 in 2019. Antiviral drugs and vaccines may be insufficient to prevent their spread. This is an update of a Cochrane Review last published in 2020. We include results from studies from the current COVID‐19 pandemic.


To assess the effectiveness of physical interventions to interrupt or reduce the spread of acute respiratory viruses.

Search methods

We searched CENTRAL, PubMed, Embase, CINAHL, and two trials registers in October 2022, with backwards and forwards citation analysis on the new studies.

Selection criteria

We included randomised controlled trials (RCTs) and cluster‐RCTs investigating physical interventions (screening at entry ports, isolation, quarantine, physical distancing, personal protection, hand hygiene, face masks, glasses, and gargling) to prevent respiratory virus transmission. 

Data collection and analysis

We used standard Cochrane methodological procedures.

Main results

We included 11 new RCTs and cluster‐RCTs (610,872 participants) in this update, bringing the total number of RCTs to 78. Six of the new trials were conducted during the COVID‐19 pandemic; two from Mexico, and one each from Denmark, Bangladesh, England, and Norway. We identified four ongoing studies, of which one is completed, but unreported, evaluating masks concurrent with the COVID‐19 pandemic.

Many studies were conducted during non‐epidemic influenza periods. Several were conducted during the 2009 H1N1 influenza pandemic, and others in epidemic influenza seasons up to 2016. Therefore, many studies were conducted in the context of lower respiratory viral circulation and transmission compared to COVID‐19. The included studies were conducted in heterogeneous settings, ranging from suburban schools to hospital wards in high‐income countries; crowded inner city settings in low‐income countries; and an immigrant neighbourhood in a high‐income country. Adherence with interventions was low in many studies.

The risk of bias for the RCTs and cluster‐RCTs was mostly high or unclear.

Medical/surgical masks compared to no masks

We included 12 trials (10 cluster‐RCTs) comparing medical/surgical masks versus no masks to prevent the spread of viral respiratory illness (two trials with healthcare workers and 10 in the community). Wearing masks in the community probably makes little or no difference to the outcome of influenza‐like illness (ILI)/COVID‐19 like illness compared to not wearing masks (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.84 to 1.09; 9 trials, 276,917 participants; moderate‐certainty evidence. Wearing masks in the community probably makes little or no difference to the outcome of laboratory‐confirmed influenza/SARS‐CoV‐2 compared to not wearing masks (RR 1.01, 95% CI 0.72 to 1.42; 6 trials, 13,919 participants; moderate‐certainty evidence). Harms were rarely measured and poorly reported (very low‐certainty evidence).

N95/P2 respirators compared to medical/surgical masks

We pooled trials comparing N95/P2 respirators with medical/surgical masks (four in healthcare settings and one in a household setting). We are very uncertain on the effects of N95/P2 respirators compared with medical/surgical masks on the outcome of clinical respiratory illness (RR 0.70, 95% CI 0.45 to 1.10; 3 trials, 7779 participants; very low‐certainty evidence). N95/P2 respirators compared with medical/surgical masks may be effective for ILI (RR 0.82, 95% CI 0.66 to 1.03; 5 trials, 8407 participants; low‐certainty evidence). Evidence is limited by imprecision and heterogeneity for these subjective outcomes. The use of a N95/P2 respirators compared to medical/surgical masks probably makes little or no difference for the objective and more precise outcome of laboratory‐confirmed influenza infection (RR 1.10, 95% CI 0.90 to 1.34; 5 trials, 8407 participants; moderate‐certainty evidence). Restricting pooling to healthcare workers made no difference to the overall findings. Harms were poorly measured and reported, but discomfort wearing medical/surgical masks or N95/P2 respirators was mentioned in several studies (very low‐certainty evidence). 

One previously reported ongoing RCT has now been published and observed that medical/surgical masks were non‐inferior to N95 respirators in a large study of 1009 healthcare workers in four countries providing direct care to COVID‐19 patients. 

Hand hygiene compared to control

Nineteen trials compared hand hygiene interventions with controls with sufficient data to include in meta‐analyses. Settings included schools, childcare centres and homes. Comparing hand hygiene interventions with controls (i.e. no intervention), there was a 14% relative reduction in the number of people with ARIs in the hand hygiene group (RR 0.86, 95% CI 0.81 to 0.90; 9 trials, 52,105 participants; moderate‐certainty evidence), suggesting a probable benefit. In absolute terms this benefit would result in a reduction from 380 events per 1000 people to 327 per 1000 people (95% CI 308 to 342). When considering the more strictly defined outcomes of ILI and laboratory‐confirmed influenza, the estimates of effect for ILI (RR 0.94, 95% CI 0.81 to 1.09; 11 trials, 34,503 participants; low‐certainty evidence), and laboratory‐confirmed influenza (RR 0.91, 95% CI 0.63 to 1.30; 8 trials, 8332 participants; low‐certainty evidence), suggest the intervention made little or no difference. We pooled 19 trials (71, 210 participants) for the composite outcome of ARI or ILI or influenza, with each study only contributing once and the most comprehensive outcome reported. Pooled data showed that hand hygiene may be beneficial with an 11% relative reduction of respiratory illness (RR 0.89, 95% CI 0.83 to 0.94; low‐certainty evidence), but with high heterogeneity. In absolute terms this benefit would result in a reduction from 200 events per 1000 people to 178 per 1000 people (95% CI 166 to 188). Few trials measured and reported harms (very low‐certainty evidence).

We found no RCTs on gowns and gloves, face shields, or screening at entry ports.

Authors' conclusions

The high risk of bias in the trials, variation in outcome measurement, and relatively low adherence with the interventions during the studies hampers drawing firm conclusions. There were additional RCTs during the pandemic related to physical interventions but a relative paucity given the importance of the question of masking and its relative effectiveness and the concomitant measures of mask adherence which would be highly relevant to the measurement of effectiveness, especially in the elderly and in young children.

There is uncertainty about the effects of face masks. The low to moderate certainty of evidence means our confidence in the effect estimate is limited, and that the true effect may be different from the observed estimate of the effect. The pooled results of RCTs did not show a clear reduction in respiratory viral infection with the use of medical/surgical masks. There were no clear differences between the use of medical/surgical masks compared with N95/P2 respirators in healthcare workers when used in routine care to reduce respiratory viral infection. Hand hygiene is likely to modestly reduce the burden of respiratory illness, and although this effect was also present when ILI and laboratory‐confirmed influenza were analysed separately, it was not found to be a significant difference for the latter two outcomes. Harms associated with physical interventions were under‐investigated.

There is a need for large, well‐designed RCTs addressing the effectiveness of many of these interventions in multiple settings and populations, as well as the impact of adherence on effectiveness, especially in those most at risk of ARIs. 

Read text here.

Tuesday, September 6, 2022

Pediatric obstructive sleep apnea—Dental professionals can play a crucial role

 Ongoing clinical research in the area of sleep disordered breathing has shown the benefit of a multidisciplinary team in treating these disorders.  Put simply,  sleep disorder treatment is not a one size fits all and you need many health care providers working together to find the right care plan.  These include the primary care provider, otolaryngologist, neurologist, pulmonologist, dentist/orthodontist, speech/occupational therapist and more.  This paper highlights the benefits of a multi-pronged strategy.


The significant contribution of dental professionals to the management of selected adult obstructive sleep apnea (OSA) cases is understood. Among children, it has also been suggested that dental professionals may also help screen and manage this morbidity in selected cases. It has also been noted that our understanding of pediatric OSA lags significantly behind adult OSA. During the screening process for potential pediatric OSA cases, dental professionals may be quite helpful as specific craniofacial abnormalities have been previously associated with pediatric OSA, including Class II malocclusion, vertical facial growth and maxillary transversal deficiency. As dental professionals assess children more frequently than physicians, they can help screen sleep-disordered breathing signs and symptoms using validated questionnaires. In more advanced cases, orthodontists may be leading contributors to the management of selected cases where a craniofacial involvement is suspected. Rapid maxillary expansion and mandibular or maxillary anterior repositioning devices have been proposed as managing alternatives. So far, there is no substantial evidence if these approaches can be adopted to treat OSA fully or if the reported OSA signs and symptoms improvements observed in a selected group of patients are stable long-term. Nevertheless, dentists and orthodontists' integration into a transdisciplinary team should be encouraged to play a significant role. This review discusses dentists or orthodontists' potential contribution to screen and manage selective pediatric OSA patients as part of a transdisciplinary team.

Read abstract here.

Monday, August 29, 2022

Children with asthma not at increased risk for SARS-CoV-2 infection, study finds

 From the start of the COVID 19 pandemic, a real ongoing concern was identifying children and adolescents who could be high risk for poor outcomes with COVID 19 infections.  Asthma was presumed to be one of these conditions.  However, although mucosal respiratory viruses all have the potential to trigger asthma exacerbations, high quality data consistent fails to show any increased risk of COVID 19 related complications.  However, another Scottish study from last year reported higher risk for hospitalization due to asthma exacerbations after a COVID 19 infection if asthma was NOT well controlled.  To put it simply, if your child has asthma make sure it is controlled.

In a new study published in Pediatrics, researchers concluded that children with asthma have similar risk for for SARS-CoV-2 infection compared with children without asthma.

“We found no evidence that children with asthma are at higher risk of COVID-19 or of developing severe illness from COVID-19,” Matthew Kelly, MD, MPH, associate professor of pediatrics and global health, associate program director of the Pediatric Infectious Diseases Fellowship and associate director of physician-scientist development in the Office of Pediatric Education at Duke University School of Medicine in Durham, North Carolina, told Healio.

Kelly and colleagues conducted a retrospective cohort study that included 46,900 children aged 5 to 17 years in the Duke University Health System with a Durham County, North Carolina, residential address. Children with asthma were classified using previously validated electronic health record-based definitions, and SARS-CoV-2 infections were identified via positive polymerase chain reaction testing of samples collected from March 2020 to September 2021. Children with asthma were matched to those without asthma.

“Because severe asthma exacerbations are often associated with respiratory virus infections, there has been concern that children with asthma who acquire SARS-CoV-2 might be at high risk for severe illness,” Kelly told Healio. “However, we and others had seen relatively few children with SARS-CoV-2 infections hospitalized with asthma exacerbations; moreover, there were some data to suggest that asthma, or the inhaled corticosteroids commonly prescribed to children with asthma, might lower the risk of acquiring SARS-CoV-2.”

Read article here.

Read study here.

Thursday, July 28, 2022

Long COVID in Children - What is it?

 COVID 19 infections in children and adolescent or rarely associated with a severe respiratory illness.  However, persistent respiratory symptoms have been reported in children after a COVID 19 infection.  With increased awareness about "long COVID" in adults, the question could be asked does such a disease exist in children.  This study attempted to answer this question by studying adolescents after COVID infection who had persistent respiratory symptoms like cough and shortness of breath.   The most common conditions identified in this small cohort of children included asthma features, paradoxical vocal fold motion, deconditioning and dysautonomia.



Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes long-term pulmonary sequelae in adults, but little is known about pulmonary outcomes in pediatrics.


The aim of this study was to describe long-term subjective and objective pulmonary abnormalities after SARS-CoV-2 infection in pediatric populations.


Single-center, retrospective cohort of patients seen in post-coronavirus disease 2019 (COVID-19) pulmonary clinic in 2021. Subjects evaluated had persistent pulmonary symptoms 4 weeks or more after initial infection. Clinical testing included a 6-min walk test (6MWT), chest X-ray, pre- and postbronchodilator spirometry, plethysmography, and diffusion capacity. Patients were followed 2-to-3-months after the initial visit with repeat testing. The primary outcome was the presence of abnormal pulmonary function testing. Secondary measures included variables associated with pulmonary outcomes.


Eighty-two adolescents were seen at a median of 3.5 months postinfection, with approximately 80% reporting two or more symptoms at clinic presentation (cough, chest pain, dyspnea at rest, and exertional dyspnea). At follow-up (~6.5 months) exertional dyspnea persisted for most (67%). Spirometry was normal in 77% of patients, but 31% had a positive bronchodilator response. No abnormalities were noted on plethysmography or diffusion capacity. Clinical phenotypes identified included inhaled corticosteroid responsiveness, paradoxical vocal fold motion disorder, deconditioning, and dysautonomia. Multivariable modeling demonstrated that obesity, anxiety, and resting dyspnea were associated with reduced 6MWT, while female sex and resting dyspnea were associated with higher Borg Dyspnea and Fatigues scores.


This is the largest study to date of pediatric patients with long-term pulmonary sequelae post-COVID-19. Identified clinical phenotypes and risk factors warrant further study and treatment.

Read article here.

Monday, April 4, 2022

New Narcolepsy Therapy?

Narcolepsy is a rare disorder associated with excessive sleepiness despite adequate sleep time.  A potentially highly efficacious therapy for narcolepsy, Xywav, is complicated by a difficult dosing regimen requiring twice nightly administration for optimal effect.  A new therapy in development by Avadel may provide a similar benefit in a once nightly dose.

 Avadel Pharmaceuticals plc, whose marketing application for narcolepsy drug candidate FT218 is under review by the US Food and Drug Administration (FDA), presented in eight posters at World Sleep 2022. FT218 is an investigational formulation of sodium oxybate designed to be taken once at bedtime for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.

Data presented at World Sleep 2022 include results from a discrete choice experiment designed to characterize and quantify drivers of preferences for attributes associated with oxybate treatments for narcolepsy, with a background survey providing patient and clinician perspectives on narcolepsy disease burden, treatment approaches, and satisfaction with current narcolepsy treatment options. New post-hoc data from the completed pivotal Phase 3 REST-ON clinical trial of FT218 and interim data from the ongoing RESTORE open-label extension/switch study of FT218 was also presented.

“We know that untreated narcolepsy can have a devastating effect on patients’ quality of life and ability to function and that additional treatment options would benefit patients and clinicians. Results from the discrete choice experiment identified that the overall driver of treatment choice for oxybate therapy is once-nightly dosing,” says Anne Marie Morse, DO, director of child neurology and pediatric sleep medicine at Geisinger Medical Center at Janet Weis Children’s Hospital, in a release. “Taken together with the robust clinical data already published, along with new post-hoc analyses from the pivotal trial and interim long-term data from the ongoing open-label study….FT218 shows great potential for patient care.”

Highlights from the Poster Presentations

  • The discreet choice experiment confirmed that once-nightly dosing, when compared to twice-nightly dosing, was the most important attribute driving both patient and clinician preference for overall oxybate product choice, as well as patient quality of life and reduction of patient anxiety/stress.
  • Dosing frequency was also viewed as a more important attribute as compared to other attributes assessed, including sodium content.
  • In the REST-ON post-hoc analyses, FT218 demonstrated improvement in subjective measures of daytime sleepiness, sleep quality, and refreshing nature of sleep as early as week 1 with the 4.5 g starting dose, with even greater improvement at week 2 soon after starting the 6 g dose compared to placebo.
  • Additional post-hoc analyses, stratified by narcolepsy type, as well as concomitant stimulant use, or without stimulants, demonstrated positive results that are generally consistent with previously reported positive endpoints from REST-ON and add to the existing body of evidence for FT218.
  • In the first presentation of an interim safety analysis from the ongoing RESTORE study, FT218 has generally been well tolerated, with some participants receiving therapy for more than 18 months; no new safety signals have emerged.

“In our first look at data from the interim analysis of the ongoing RESTORE study, we have affirmed that the tolerability of FT218 is in line with the well-established profile of sodium oxybate. We’re also pleased to share new results from our post-hoc analyses of the REST-ON trial that demonstrated clinically meaningful improvements with FT218 versus placebo in both subjective and objective measurements of narcolepsy symptoms, including EDS and disrupted nighttime sleep, with a dosing regimen preferred by patients and clinicians alike, consistent with our previous observations,” says Douglas Williamson, MD, chief medical officer of Avadel, in a release. “At Avadel, we believe in listening to patients to develop solutions that will have a meaningful impact on their symptoms. Our goal is to do just that for people living with narcolepsy, and we are working to bring FT218 to patients as a once-at-bedtime treatment option as quickly as possible.”

Read article here.

Wednesday, March 16, 2022

Sleep Awareness Week

This is Sleep Awareness Week.  Organizations such as the National Sleep Foundation routinely survey adults and find that sleep disorders are extraordinarily common and can significantly impact quality of life.  Sleep disorders in children and adolescents, though, are vastly underrecognized with between 20-30% of young children affected by disrupted sleep and 60-70% of adolescents experiencing reduced sleep time.  The effects can be numerous, including reduced cognitive function, mental health concerns, and increased metabolic and cardiovascular health risks.  A pediatric sleep specialist is NOT the sleep lab doctor.  A pediatric sleep clinic provides a comprehensive evaluation and treatment for all manners of sleep disorders to provide evidence based treatment recommendations for your entire health care team.

 To kick off Sleep Awareness Week, the National Sleep Foundation released the results from the 2022 Sleep in America Poll. The annual survey is one of the longest running records capturing Americans’ perceptions, attitudes, and behaviors around sleep. 

The 2022 Sleep in America Poll documents significant opportunities to improve daily activities that are associated with a range of positive sleep and health outcomes. Results show that many Americans are not getting bright light exposure during the day and are looking at screens around bedtime. In addition, many fall short of recommendations for exercise and take meals at inconsistent times.

Poll results show:

  • Nearly half of Americans say they aren’t exposed to the recommended levels of bright light when indoors in the morning and afternoon.
  • More than a third of Americans fall short of CDC’s recommendations for moderate or vigorous activity, another key factor in ensuring a sound sleep.
  • Four in 10 Americans eat meals at inconsistent times, making it more difficult for their bodies to regulate the sleep/wake process.
  • More than half of Americans indulge in screen time within an hour before bed or even while in bed.

“Over the last 31 years, the National Sleep Foundation has conducted the Sleep in America Poll to gain a better understanding of Americans’ sleep health and habits. These latest results highlight how people are doing with key daytime behaviors, knowing that what we do during the day and at night is important for sleep,” says John Lopos, CEO, National Sleep Foundation, in a release. “The best practices we continue to share can help you become your ‘Best Slept Self’— and by that we mean the radiant, positive feeling reflected in the way you look, feel, and navigate the day.”

Things you can do to help be your Best Slept Self:

  • Increase exposure to bright light upon waking and throughout the afternoon.
  • Help regulate your body’s sleep/wake process by eating meals at consistent times during the day and avoiding heavy meals 2-3 hours before bed.
  • Avoid screentime at least one hour before bed.
  • Make your bedroom a sleep-friendly space by keeping it cool, dark, and quiet.
  • Follow recommended guidelines on proper exercise to improve overall health and your sleep. Aim for at least 20 minutes of exercise a day.
  • Get the recommended hours of sleep per night. The National Sleep Foundation recommends 7-9 hours for most adults.

The Sleep in America Poll is fielded annually and results are shared during National Sleep Foundation’s Sleep Awareness Week. Sleep Awareness Week runs Sunday, March 13 through March 19. NSF independently produces Sleep Awareness Week, the Sleep in America Poll, and all related official educational content.

Sleep Awareness Week 2022 is supported by unrestricted funds from Jazz Pharmaceuticals, Eisai, Inc., Avadel Pharmaceuticals, Graber, Harmony Biosciences, Huckleberry, Idorsia, and PureCare. 

Read article here.

Monday, March 7, 2022

Asthma Education Reduces Hospitalization and Emergency Room Risk


Asthma is a complex respiratory disorder that significantly raises risk for ER visits and hospitalizations.  Despite it's complexity, there is a consistent knowledge gap that can put patients and parents at a significant disadvantage.  Following a consistent strategy grounded in evidenced based practice can make a difference in reducing chaos and preventing frequent sick visits.  This study demonstrated that a focused asthma education program consistently reduced these risks.

Background It remains unknown whether child-oriented asthma education is associated with better health outcomes. This meta-analysis investigated the effects of asthma education on hospitalisation and emergency department and clinic visits.

Methods We searched the Cochrane Library, PubMed and EMBASE for relevant studies from inception to 4 July 2021, and selected studies that reported hospitalisation or emergency department or clinic visits as outcomes. The participants were only children. Two authors independently selected the studies, assessed the quality of the included studies and retrieved the data. A third senior author was engaged to resolve disagreements. Fifteen longitudinal studies were included for the systematic review and meta-analysis. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 was used as the standard of reporting (PRISMA registration ID is 284509).

Findings Compared with the control group, the asthma education group had 54% lower hospitalisation risk (95% CI 0.32 to 0.66), and 31% lower emergency department visit risk (95% CI 0.59 to 0.81). Sensitivity analysis showed that the asthma education group had a reduced clinic visit risk (risk ratio (RR)=0.80, 95% CI 0.67 to 0.97). Subgroup analysis showed that asthma education involving both children and parents/guardians was associated with fewer hospitalisations (RR=0.38, 95% CI 0.24 to 0.59) and emergency department visits (RR=0.69, 95% CI 0.57 to 0.83). Asthma education in hospitals or non-hospitals can reduce the risk of hospitalisation and emergency department visits. However, only education in the hospitals was associated with the reduction of clinical visits (RR=0.45, 95% CI 0.22 to 0.92).

Interpretation Education is effective for controlling asthma, especially for reducing hospitalisation and emergency department and clinic visits. Education involving both children and parents/guardians is more effective than that involving only children. The setting of asthma education does not impact its effect to a large extent.

Read article here.