Publications by authors named "Claire Hopkins"

138 Publications

Interventions for the treatment of persistent post-COVID-19 olfactory dysfunction.

Cochrane Database Syst Rev 2021 Jul 22;7:CD013876. Epub 2021 Jul 22.

Cochrane UK, Oxford, UK.

Background: Olfactory dysfunction is an early and sensitive marker of COVID-19 infection. Although self-limiting in the majority of cases, when hyposmia or anosmia persists it can have a profound effect on quality of life. Little guidance exists on the treatment of post-COVID-19 olfactory dysfunction, however several strategies have been proposed from the evidence relating to the treatment of post-viral anosmia (such as medication or olfactory training).

Objectives: To assess the effects (benefits and harms) of interventions that have been used, or proposed, to treat persisting olfactory dysfunction due to COVID-19 infection. A secondary objective is to keep the evidence up-to-date, using a living systematic review approach.  SEARCH METHODS: The Cochrane ENT Information Specialist searched the Cochrane COVID-19 Study Register; Cochrane ENT Register; CENTRAL; Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished studies. The date of the search was 16 December 2020.

Selection Criteria: Randomised controlled trials including participants who had symptoms of olfactory disturbance following COVID-19 infection. Only individuals who had symptoms for at least four weeks were included in this review. Studies compared any intervention with no treatment or placebo.

Data Collection And Analysis: We used standard Cochrane methodological procedures. Primary outcomes were the recovery of sense of smell, disease-related quality of life and serious adverse effects. Secondary outcomes were the change in sense of smell, general quality of life, prevalence of parosmia and other adverse effects (including nosebleeds/bloody discharge). We used GRADE to assess the certainty of the evidence for each outcome.

Main Results: We included one study with 18 participants, which compared the use of a 15-day course of oral steroids combined with nasal irrigation (consisting of an intranasal steroid/mucolytic/decongestant solution) with no intervention. Psychophysical testing was used to assess olfactory function at baseline, 20 and 40 days. Systemic corticosteroids plus intranasal steroid/mucolytic/decongestant compared to no intervention Recovery of sense of smell was assessed after 40 days (25 days after cessation of treatment) using the Connecticut Chemosensory Clinical Research Center (CCCRC) score. This tool has a range of 0 to 100, and a score of ≥ 90 represents normal olfactory function. The evidence is very uncertain about the effect of this intervention on recovery of the sense of smell at one to three months (5/9 participants in the intervention group scored ≥ 90 compared to 0/9 in the control group; risk ratio (RR) 11.00, 95% confidence interval (CI) 0.70 to 173.66; 1 study; 18 participants; very low-certainty evidence). Change in sense of smell was assessed using the CCCRC score at 40 days. This study reported an improvement in sense of smell in the intervention group from baseline (median improvement in CCCRC score 60, interquartile range (IQR) 40) compared to the control group (median improvement in CCCRC score 30, IQR 25) (1 study; 18 participants; very low-certainty evidence). Serious adverse events andother adverse events were not identified in any participants of this study; however, it is unclear how these outcomes were assessed and recorded (1 study; 18 participants; very low-certainty evidence).

Authors' Conclusions: There is very limited evidence available on the efficacy and harms of treatments for persistent olfactory dysfunction following COVID-19 infection. However, we have identified other ongoing trials in this area. As this is a living systematic review we will update the data regularly, as new results become available. For this (first) version of the living review we identified only one study with a small sample size, which assessed systemic steroids and nasal irrigation (intranasal steroid/mucolytic/decongestant). However, the evidence regarding the benefits and harms from this intervention to treat persistent post-COVID-19 olfactory dysfunction is very uncertain.
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http://dx.doi.org/10.1002/14651858.CD013876.pub2DOI Listing
July 2021

Interventions for the prevention of persistent post-COVID-19 olfactory dysfunction.

Cochrane Database Syst Rev 2021 Jul 22;7:CD013877. Epub 2021 Jul 22.

Cochrane UK, Oxford, UK.

Background: Loss of olfactory function is well recognised as a cardinal symptom of COVID-19 infection, and the ongoing pandemic has resulted in a large number of affected individuals with abnormalities in their sense of smell. For many, the condition is temporary and resolves within two to four weeks. However, in a significant minority the symptoms persist. At present, it is not known whether early intervention with any form of treatment (such as medication or olfactory training) can promote recovery and prevent persisting olfactory disturbance.  OBJECTIVES: To assess the effects (benefits and harms) of interventions that have been used, or proposed, to prevent persisting olfactory dysfunction due to COVID-19 infection. A secondary objective is to keep the evidence up-to-date, using a living systematic review approach.  SEARCH METHODS: The Cochrane ENT Information Specialist searched the Cochrane COVID-19 Study Register; Cochrane ENT Register; CENTRAL; Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished studies. The date of the search was 16 December 2020.

Selection Criteria: Randomised controlled trials including participants who had symptoms of olfactory disturbance following COVID-19 infection. Individuals who had symptoms for less than four weeks were included in this review. Studies compared any intervention with no treatment or placebo.  DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. Our primary outcomes were the presence of normal olfactory function, serious adverse effects and change in sense of smell. Secondary outcomes were the prevalence of parosmia, change in sense of taste, disease-related quality of life and other adverse effects (including nosebleeds/bloody discharge). We used GRADE to assess the certainty of the evidence for each outcome.  MAIN RESULTS: We included one study of 100 participants, which compared an intranasal steroid spray to no intervention. Participants in both groups were also advised to undertake olfactory training for the duration of the trial. Data were identified for only two of the prespecified outcomes for this review, and no data were available for the primary outcome of serious adverse effects. Intranasal corticosteroids compared to no intervention (all using olfactory training) Presence of normal olfactory function after three weeks of treatment was self-assessed by the participants, using a visual analogue scale (range 0 to 10, higher scores = better). A score of 10 represented "completely normal smell sensation". The evidence is very uncertain about the effect of intranasal corticosteroids on self-rated recovery of sense of smell (estimated absolute effect 619 per 1000 compared to 520 per 1000, risk ratio (RR) 1.19, 95% confidence interval (CI) 0.85 to 1.68; 1 study; 100 participants; very low-certainty evidence).  Change in sense of smell was not reported, but the self-rated score for sense of smell was reported at the endpoint of the study with the same visual analogue scale (after three weeks of treatment). The median scores at endpoint were 10 (interquartile range (IQR) 9 to 10) for the group receiving intranasal corticosteroids, and 10 (IQR 5 to 10) for the group receiving no intervention (1 study; 100 participants; very low-certainty evidence).

Authors' Conclusions: There is very limited evidence regarding the efficacy of different interventions at preventing persistent olfactory dysfunction following COVID-19 infection. However, we have identified a small number of additional ongoing studies in this area. As this is a living systematic review, the evidence will be updated regularly to incorporate new data from these, and other relevant studies, as they become available.  For this (first) version of the living review, we identified a single study of intranasal corticosteroids to include in this review, which provided data for only two of our prespecified outcomes. The evidence was of very low certainty, therefore we were unable to determine whether intranasal corticosteroids may have a beneficial or harmful effect.
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http://dx.doi.org/10.1002/14651858.CD013877.pub2DOI Listing
July 2021

Correlations between olfactory psychophysical scores and SARS-CoV-2 viral load in COVID-19 patients.

Laryngoscope 2021 Jul 19. Epub 2021 Jul 19.

Biomedical Science PhD School, Biomedical Science Department, University of Sassari, Italy.

Objective: The aim of this study was to evaluate the correlations between the severity and duration of olfactory dysfunctions (OD), assessed with psychophysical tests, and the viral load on the rhino-pharyngeal swab determined with a direct method, in patients affected by coronavirus disease 2019 (COVID-19).

Methods: Patients underwent psychophysical olfactory assessment with Connecticut Chemosensory Clinical Research Center test and determination of the normalized viral load on nasopharyngeal swab within 10 days of the clinical onset of COVID-19.

Results: Sixty COVID-19 patients were included in this study. On psychophysical testing 12 patients (20% of the cohort) presented with anosmia, 11 (18.3%) severe hyposmia, 13 (18.3%) moderate hyposmia and 10 (16.7%) mild hyposmia with an overall prevalence of OD of 76.7%. The overall median olfactory score was 50 (IQR 30-72.5) with no significant differences between clinical severity subgroups. The median normalized viral load detected in the series was 2.56E+06 viral copies/10 copies of human beta-2microglobulin mRNA present in the sample (IQR 3.17E+04-1.58E+07) without any significant correlations with COVID-19 severity. The correlation between viral load and olfactory scores at baseline (R  = 0.0007; p = 0.844) and 60-day follow-up (R  = 0.0077; p = 0.519) was weak and not significant.

Conclusions: the presence of OD does not seem to be useful in identifying subjects at risk for being super-spreaders nor who is at risk of developing long-term OD. Similarly, the pathogenesis of OD is probably related to individual factors rather than to viral load and activity. This article is protected by copyright. All rights reserved.
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http://dx.doi.org/10.1002/lary.29777DOI Listing
July 2021

Short-Term Efficacy and Safety of Oral and Nasal Corticosteroids in COVID-19 Patients with Olfactory Dysfunction: A European Multicenter Study.

Pathogens 2021 Jun 4;10(6). Epub 2021 Jun 4.

COVID-19 Task Force of the Young-Otolaryngologists of the International Federations of Oto-Rhino-Laryngological Societies (YO-IFOS), 75000 Paris, France.

: The objective of this study was to investigate the efficacy and safety of early administration of oral corticosteroids (OC) or nasal corticosteroids (NC) as an add-on to olfactory training (OT) versus OT alone in patients with olfactory dysfunction (OD) related to coronavirus disease 2019 (COVID-19). : Patients with a positive diagnosis of COVID-19 and OD were prospectively recruited from March 22 to December 15, 2020 from 4 European hospitals. Patients had confirmed OD on psychophysical testing. All patients undertook OT, with add-on 10 days of OC (group 1: OC + OT), or 1 month of NC (group 2: NC + OT) or olfactory training alone (group 3: OT). Olfactory evaluations (Sniffin'Sticks tests) were carried out at the time of inclusion, 1 and 2 months after the start of the therapeutic course. : A total of 152 hyposmic or anosmic patients completed the study. Group 1, 2 and 3 included 59, 22 and 71 patients, respectively and all patient groups were comparable regarding baseline Sniffin'Sticks tests. The median Sniffin'Sticks test values significantly improved from pre- to post-intervention in all groups. The increase of Sniffin'Sticks test values was higher in group 1 (OC + OT) compared with groups 2 and 3 ( < 0.001) at one month after treatment but did not remain so at 2 months. Groups 1, 2 and 3, respectively, presented parosmia in 20/71 (28.2%), 9/22 (40.9%) and 42/71 (59.2%) patients. This difference was statistically significant between group 1 and 3 ( < 0.001). There were no patients with a worsening of the disease or an increase of the severity of the COVID-19 symptoms. : The use of OCs in patients with OD related to mild COVID-19 is generally well-tolerated without any case of deterioration of symptoms. OC is associated with greater improvement in psychophysical olfactory evaluations at 1-month post-treatment but there was no difference at 2 months. Parosmia may be reduced following treatment with OC and NC. On the basis of these preliminary results, it is possible to state that considering the 2 months efficacy of OC and NC with respect to the OT alone and the risk-benefit ratio, the benefit to start a specific treatment of COVID-19 related OD cannot be demonstrated and there is a need for a randomised controlled trial to assess this further.
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http://dx.doi.org/10.3390/pathogens10060698DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8228154PMC
June 2021

Predictive factors of smell recovery in a clinical series of 288 coronavirus disease 2019 patients with olfactory dysfunction.

Eur J Neurol 2021 Jun 22. Epub 2021 Jun 22.

Institute for Medical Immunology, Université libre de Bruxelles, Charleroi, Belgium.

Background And Purpose: The aim was to evaluate potential predictive factors of smell recovery in a clinical series of 288 patients presenting olfactory dysfunction (OD) related to coronavirus disease 2019 (COVID-19). Potential correlations were sought between epidemiological, clinical and immunological characteristics of patients and the persistence of OD at 60 days.

Methods: COVID-19 positive patients presenting OD were prospectively recruited from three European hospitals. Baseline clinical and olfactory evaluations were performed within the first 2 weeks after OD onset and repeated at 30 and 60 days. In a subgroup of patients, anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies were measured in serum, saliva and nasal secretions at 60 days.

Results: A total of 288 COVID-19 patients with OD were included in the study. Two weeks after the onset of the loss of smell, 52.4% of patients had OD on psychophysical tests, including 113 cases (39.2%) of anosmia and 38 cases (13.2%) of hyposmia. At 60-day follow-up, 25.4% of the patients presented persistent OD. There was no significant correlation between sex, age, viral load on nasopharyngeal swab or COVID-19 severity and poor olfactory outcome. In a subgroup of 63 patients, it was demonstrated that patients with poor olfactory outcomes at 60 days had lower levels of salivary and nasal immunoglobulin G (IgG) and IgG1, but similar levels of antibodies in the serum.

Conclusions: No clinical markers predicted the evolution of OD at 60 days. Patients with poor olfactory outcome at 60 days had lower saliva and nasal antibodies, suggesting a role for local immune responses in the persistence of COVID-19 related OD.
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http://dx.doi.org/10.1111/ene.14994DOI Listing
June 2021

Correlations between IL-6 serum level and olfactory dysfunction severity in COVID-19 patients: a preliminary study.

Eur Arch Otorhinolaryngol 2021 May 13. Epub 2021 May 13.

Maxillofacial Surgery Operative Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Viale San Pietro 43/B, 07100, Sassari, Italy.

Background: Interleukin 6 (IL-6) is a proinflammatory cytokine that is secreted by cells infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and it is widely recognized as a negative prognostic factor. The purpose of this study was to analyze the correlations between the olfactory scores determined by psychophysical tests and the serum levels of IL-6 in patients affected by coronavirus disease 2019 (COVID-19) METHODS: Patients underwent psychophysical olfactory assessment with Connecticut Chemosensory Clinical Research Center test and IL-6 plasma level determination within 10 days of the clinical onset of COVID-19.

Results: Seventy-four COVID-19 patients were included in this study. COVID-19 staged as mild in 34 patients, moderate in 26 and severe in 14 cases. There were no significant differences in olfactory scores across the different COVID-19 severity groups. In the patient series, the median plasma level of IL-6 was 7.7 pg/mL (IQR 3.7-18.8). The concentration of IL-6 was found to be significantly correlated with the severity of COVID-19 with a directly proportional relationship. The correlation between IL-6 plasma concentrations and olfactory scores was weak (r = 0.182) and not significant (p = 0.12).

Conclusions: In COVID-19 patients, psychophysical olfactory scores did not show significant correlations with the plasma levels of a well-recognized negative prognostic factor such as IL-6. This observation casts some shadows on the positive prognostic value of olfactory dysfunctions.
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http://dx.doi.org/10.1007/s00405-021-06868-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8117453PMC
May 2021

Self-reported smell and taste recovery in coronavirus disease 2019 patients: a one-year prospective study.

Eur Arch Otorhinolaryngol 2021 May 7. Epub 2021 May 7.

Department of Medical, Surgical and Health Sciences, Section of Otolaryngology, University of Trieste, Trieste, Italy.

Purpose: The aim of the present study was to estimate the 1 year prevalence and recovery rate of self-reported chemosensory dysfunction in a series of subjects with previous mild-to-moderate symptomatic COVID-19.

Methods: Prospective study based on the SNOT-22, item "sense of smell or taste" and additional outcomes.

Results: 268/315 patients (85.1%) completing the survey at baseline also completed the follow-up interview. The 12 months prevalence of self-reported COVID-19 associated chemosensory dysfunction was 21.3% (95% CI 16.5-26.7%). Of the 187 patients who complained of COVID-19 associated chemosensory dysfunction at baseline, 130 (69.5%; 95% CI 62.4-76.0%) reported complete resolution of smell or taste impairment, 41 (21.9%) reported a decrease in the severity, and 16 (8.6%) reported the symptom was unchanged or worse 1 year after onset. The risk of persistence was higher for patients reporting a baseline SNOT-22 score ≥ 4 (OR = 3.32; 95% CI 1.32-8.36) as well as for those requiring ≥ 22 days for a negative swab (OR = 2.18; 95% CI 1.12-4.27).

Conclusion: A substantial proportion of patients with previous mild-to-moderate symptomatic COVID-19 characterized by new onset of chemosensory dysfunction still complained on altered sense of smell or taste 1 year after the onset.
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http://dx.doi.org/10.1007/s00405-021-06839-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8103884PMC
May 2021

The Nonsurgical Rhinoplasty: A Retrospective Review of 5000 Treatments.

Plast Reconstr Surg 2021 Jun;147(6):1066e-1067e

Aix Marseille University, Assistance Publique des Hôpitaux de Marseille, Institut Universitaire des Systèmes Thermiques Industriels, Department of Otorhinolaryngology and Head and Neck Surgery, La Conception University Hospital, Marseille, France.

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http://dx.doi.org/10.1097/PRS.0000000000007929DOI Listing
June 2021

Safety review of current systemic treatments for severe chronic rhinosinusitis with nasal polyps and future directions.

Expert Opin Drug Saf 2021 May 18:1-13. Epub 2021 May 18.

ENT Department, Guy's and St Thomas NHS Foundation Trust, London, UK.

Chronic rhinosinusitis is a common condition characterized by inflammation of the nasal and sinus linings, rhinorrhea, nasal blockage, facial pain, and loss of sense of smell for longer than 12 weeks. CRS can occur with or without nasal polyps. First-line treatment in chronic rhinosinusitis with nasal polyps is long-term intranasal corticosteroids, which have few adverse events associated with their use, as second-generation intranasal corticosteroids having a bioavailability of <0.5%. Systemic corticosteroids are used when intranasal steroids fail to achieve symptom control. However, the repeated use of oral corticosteroids is associated with numerous adverse events and the benefit from a course of oral corticosteroids is lost within three to six months. Antibiotics are commonly prescribed in nasal polyposis although there is also very little evidence for their use outside of acute infection. Macrolide antibiotics are also associated with a transient increase in the risk of arrhythmias. Biologics offer a steroid-sparing alternative to the treatment of severe nasal polyposis. They have shown to be relatively well tolerated in studies to date; however, studies suggest that there is no disease modifying effect and that any benefit is lost within weeks of finishing treatment.
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http://dx.doi.org/10.1080/14740338.2021.1926981DOI Listing
May 2021

Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial.

Lancet Respir Med 2021 Apr 16. Epub 2021 Apr 16.

Department of ENT, Guy's Hospital, London, UK; St Thomas' Hospital, King's College London, London, UK.

Background: Chronic rhinosinusitis with nasal polyps affects approximately 2-4% of the general population, and long-term use of systemic corticosteroids is associated with adverse effects. The aim of this study was to assess the efficacy and safety of mepolizumab in adults with recurrent, refractory severe bilateral chronic rhinosinusitis with nasal polyps.

Methods: SYNAPSE was a randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial done at 93 centres, mainly hospitals, in 11 countries. Eligible patients were aged 18 years or older with recurrent, refractory, severe, bilateral nasal polyp symptoms (nasal obstruction symptom visual analogue scale [VAS] score of >5), were eligible for repeat nasal surgery (overall symptoms VAS score >7 and endoscopic nasal polyps score of ≥5, with a minimum score of 2 in each nasal cavity) despite standard of care treatment, and had to have at least one nasal surgery in the past 10 years. Patients were randomly assigned (1:1), using permuted block design, to receive either 100 mg mepolizumab subcutaneously or placebo once every 4 weeks, in addition to standard of care (mometasone furoate intranasal spray for at least 8 weeks before screening and during the study, saline nasal irrigations, systemic corticosteroids or antibiotics, or both), as required, for 52 weeks. Site staff, the central study team, and patients were masked to study treatment and absolute blood eosinophil counts. The coprimary endpoints were change from baseline in total endoscopic nasal polyp score at week 52 and in mean nasal obstruction VAS score during weeks 49-52, assessed in the intention-to-treat population (ITT). This study is registered with ClinicalTrials.gov, NCT03085797.

Findings: From May 25, 2017, to Dec 12, 2018, 854 patients were screened for eligibility. 414 patients were randomly assigned with 407 included in the ITT population; 206 received mepolizumab and 201 received placebo. Total endoscopic nasal polyp score significantly improved at week 52 from baseline with mepolizumab versus placebo (adjusted difference in medians -0·73, 95% CI -1·11 to -0·34; p<0·0001) and nasal obstruction VAS score during weeks 49-52 also significantly improved (-3·14, -4·09 to -2·18; p<0·0001). Adverse events considered related to study treatment were reported in 30 (15%) of 206 patients receiving mepolizumab and 19 (9%) of 201 receiving placebo. On-treatment serious adverse events occurred in 12 (6%) patients receiving mepolizumab and 13 (6%) receiving placebo; none were considered related to treatment in those receiving mepolizumab. One death was reported in the placebo group (myocardial infarction; death occurred 99 days after the last dose) and was considered unrelated to the treatment.

Interpretation: Mepolizumab treatment improved nasal polyp size and nasal obstruction compared with placebo, with no new safety indications, in patients with recurrent, refractory severe chronic rhinosinusitis with nasal polyps. These findings suggest that mepolizumab provides an effective add-on treatment option to standard of care in this population.

Funding: GlaxoSmithKline.
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http://dx.doi.org/10.1016/S2213-2600(21)00097-7DOI Listing
April 2021

British Rhinological Society Consensus Guidance on the use of biological therapies for chronic rhinosinusitis with nasal polyps.

Clin Otolaryngol 2021 Apr 5. Epub 2021 Apr 5.

Royal National Throat, Nose and Ear Hospital, UCLH Foundation Trust, London, UK.

Objectives: We set out to create Consensus Guidelines, based on current evidence and relative risks of adverse effects and the costs of different treatments, which reflect the views of the British Rhinological Society (BRS) Council on where the use of biologics should be positioned within treatment pathways for CRSwNP, specifically in the setting of the National Health Service (NHS).

Design: An expert panel of 16 members was assembled. A review of the literature and evidence synthesis was undertaken and circulated to the panel. We used the RAND/UCLA methodology with a multi-step process to make recommendations on the use of biologics.

Setting: N/A.

Participants: N/A.

Results: Recommendations were made, based on underlying disease severity, prior treatments and co-morbidities. A group of patients for whom biologics were considered an appropriate treatment option for CRSwNP was defined.

Conclusions: Although biologics are not currently available for the treatment of CRSwNP, the BRS Council have defined a group of patients who have higher rates of "failure" with current treatment pathways, higher resource use and are more likely to suffer with uncontrolled symptoms. We would urge NICE to consider approval of biologics for such indications without applying further restrictions on use.
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http://dx.doi.org/10.1111/coa.13779DOI Listing
April 2021

Socioeconomic, comorbidity, lifestyle, and quality of life comparisons between chronic rhinosinusitis phenotypes.

Laryngoscope 2021 Mar 26. Epub 2021 Mar 26.

Norwich Medical School, University of East Anglia, Norfolk, UK.

Background: Chronic rhinosinusitis (CRS) is a heterogeneous group of inflammatory sinonasal disorders with key defining symptoms, but traditionally separated into phenotypes by clinical/endoscopic findings. It is not known whether the two phenotypes have differing socioeconomic, comorbidity, and lifestyle differences. This analysis of the Chronic Rhinosinusitis Epidemiology Study (CRES) database sought to analyze any key differences in the socioeconomic variables between those with CRS with nasal polyps (CRSwNPs) and those without nasal polyps (CRSsNPs). We also sought to analyze differences in comorbidities, lifestyle, and quality of life.

Methods: Patients with a confirmed diagnosis of CRS in secondary and tertiary care outpatient settings in the UK were invited to participate in a questionnaire-based case-control study. Variables included demographics, socioeconomic factors, comorbidities, lifestyle factors, and health-related quality of life (HRQoL) (level 3 evidence).

Results: A total of 1204 patients' data were analyzed: 553 CRSsNP and 651 CRSwNP participants. The key socioeconomic variables did not demonstrate any notable differences, nor did lifestyle variables other than alcohol consumption being higher in those with CRSwNP (P = .032), but the latter was not significant after adjusting for age and sex. Aside from confirmation of asthma being more common in CRSwNP, it was notable that this group complained less of upper respiratory tract infections (URTIs), and CRSsNP participants showed evidence of worse HRQoL scores in respect of body pain (P = .001).

Conclusions: Patients with CRSwNP experience higher rates of asthma and lower rates of URTIs; patients with CRSsNP have worse body pain scores. Otherwise, there are no demonstrable significant socioeconomic, comorbidity, lifestyle, or quality of life differences between the two phenotypes.

Level Of Evidence: 3 Laryngoscope, 2021.
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http://dx.doi.org/10.1002/lary.29527DOI Listing
March 2021

Biologics for chronic rhinosinusitis.

Cochrane Database Syst Rev 2021 03 12;3:CD013513. Epub 2021 Mar 12.

Cochrane UK, Oxford, UK.

Background: This living systematic review is one of several Cochrane Reviews evaluating the medical management of patients with chronic rhinosinusitis. Chronic rhinosinusitis is common. It is characterised by inflammation of the nasal and sinus linings, nasal blockage, rhinorrhoea, facial pressure/pain and loss of sense of smell. It occurs with or without nasal polyps.   'Biologics' are medicinal products produced by a biological process. Monoclonal antibodies are one type, already evaluated in other inflammatory conditions (e.g. asthma and atopic dermatitis).

Objectives: To assess the effects of biologics for the treatment of chronic rhinosinusitis.

Search Methods: The Cochrane ENT Information Specialist searched the Cochrane ENT Register; CENTRAL (2020, Issue 9); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished studies. The date of the search was 28 September 2020.

Selection Criteria: Randomised controlled trials (RCTs) with at least three months follow-up comparing biologics (monoclonal antibodies) against placebo/no treatment in patients with chronic rhinosinusitis.

Data Collection And Analysis: We used standard Cochrane methodological procedures. Our primary outcomes were disease-specific health-related quality of life (HRQL), disease severity and serious adverse events (SAEs). The secondary outcomes were avoidance of surgery, extent of disease (measured by endoscopic or computerised tomography (CT) score), generic HRQL and adverse effects (nasopharyngitis, including sore throat). We used GRADE to assess the certainty of the evidence for each outcome.

Main Results: We included 10 studies. Of 1262 adult participants, 1260 had severe chronic rhinosinusitis with nasal polyps; 43% to 100% of participants also had asthma. Three biologics, with different targets, were evaluated: dupilumab, mepolizumab and omalizumab. All of the studies were sponsored or supported by industry. For this update (2021) we have included two new studies, including 265 participants, which reported data relating to omalizumab. Anti-IL-4Rα mAb (dupilumab) versus placebo/no treatment (all receiving intranasal steroids) Three studies (784 participants) evaluated dupilumab. Disease-specific HRQL was measured with the SNOT-22 (a 22-item questionnaire, with a score range of 0 to 110; minimal clinically important difference (MCID) 8.9 points). At 24 weeks, dupilumab results in a large reduction (improvement) in the SNOT-22 score (mean difference (MD) -19.61, 95% confidence interval (CI) -22.54 to -16.69; 3 studies; 784 participants; high certainty). At between 16 and 52 weeks of follow-up, dupilumab probably results in a large reduction in disease severity, as measured by a 0- to 10-point visual analogue scale (VAS) (MD -3.00, 95% CI -3.47 to -2.53; 3 studies; 784 participants; moderate certainty). This is a global symptom score, including all aspects of chronic rhinosinusitis symptoms. At between 16 and 52 weeks of follow-up, dupilumab may result in a reduction in serious adverse events compared to placebo (5.9% versus 12.5%, risk ratio (RR) 0.47, 95% CI 0.29 to 0.76; 3 studies, 782 participants; low certainty). Anti-IL-5 mAb (mepolizumab) versus placebo/no treatment (all receiving intranasal steroids) Two studies (137 participants) evaluated mepolizumab. Disease-specific HRQL was measured with the SNOT-22. At 25 weeks, the SNOT-22 score may be reduced (improved) in participants receiving mepolizumab (MD -13.26 points, 95% CI -22.08 to -4.44; 1 study; 105 participants; low certainty; MCID 8.9).  It is very uncertain whether there is a difference in disease severity at 25 weeks: on a 0- to 10-point VAS, disease severity was -2.03 lower in those receiving mepolizumab (95% CI -3.65 to -0.41; 1 study; 72 participants; very low certainty). It is very uncertain if there is a difference in the number of serious adverse events at between 25 and 40 weeks (1.4% versus 0%; RR 1.57, 95% CI 0.07 to 35.46; 2 studies; 135 participants, very low certainty). Anti-IgE mAb (omalizumab) versus placebo/no treatment (all receiving intranasal steroids) Five studies (329 participants) evaluated omalizumab. Disease-specific HRQL was measured with the SNOT-22. At 24 weeks omalizumab probably results in a large reduction in SNOT-22 score (MD -15.62, 95% CI -19.79 to -11.45; 2 studies; 265 participants; moderate certainty; MCID 8.9). We did not identify any evidence for overall disease severity. It is very uncertain whether omalizumab affects the number of serious adverse events, with follow-up between 20 and 26 weeks (0.8% versus 2.5%, RR 0.32, 95% CI 0.05 to 2.00; 5 studies; 329 participants; very low certainty).

Authors' Conclusions: Almost all of the participants in the included studies had nasal polyps (99.8%) and all were using topical nasal steroids for their chronic rhinosinusitis symptoms. In these patients, dupilumab improves disease-specific HRQL compared to placebo. It probably also results in a reduction in disease severity, and may result in a reduction in the number of serious adverse events. Mepolizumab may improve disease-specific HRQL. It is very uncertain if there is a difference in disease severity or the number of serious adverse events. Omalizumab probably improves disease-specific HRQL compared to placebo. It is very uncertain if there is a difference in the number of serious adverse events. There was no evidence regarding the effect of omalizumab on disease severity (using global scores that address all symptoms of chronic rhinosinusitis).
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http://dx.doi.org/10.1002/14651858.CD013513.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8094915PMC
March 2021

Efficacy and safety of treatment with biologicals for severe chronic rhinosinusitis with nasal polyps: A systematic review for the EAACI guidelines.

Allergy 2021 Aug 24;76(8):2337-2353. Epub 2021 Mar 24.

Department of Clinical Immunology, University of Wroclaw, Wroclaw, Poland.

This systematic review evaluates the efficacy and safety of biologicals for chronic rhinosinusitis with nasal polyps (CRSwNP) compared with the standard of care. PubMed, Embase, and Cochrane Library were searched for RCTs. Critical and important CRSwNP-related outcomes were considered. The risk of bias and the certainty of the evidence were assessed using GRADE. RCTs evaluated (dupilumab-2, omalizumab-4, mepolizumab-2, and reslizumab-1) included 1236 adults, with follow-up of 20-64 weeks. Dupilumab reduces the need for surgery (NFS) or oral corticosteroid (OCS) use (RR 0.28; 95% CI 0.20-0.39, moderate certainty) and improves with high certainty smell evaluated with UPSIT score (mean difference (MD) +10.54; 95% CI +9.24 to +11.84) and quality of life (QoL) evaluated with SNOT-22 (MD -19.14; 95% CI -22.80 to -15.47), with fewer treatment-related adverse events (TAEs) (RR 0.95; 95% CI 0.89-1.02, moderate certainty). Omalizumab reduces NFS (RR 0.85; 95% CI 0.78-0.92, high certainty), decreases OCS use (RR 0.38; 95% CI 0.10-1.38, moderate certainty), and improves high certainty smell (MD +3.84; 95% CI +3.64 to +4.04) and QoL (MD -15.65; 95% CI -16.16 to -15.13), with increased TAE (RR 1.73; 95% CI 0.60-5.03, moderate certainty). There is low certainty for mepolizumab reducing NFS (RR 0.78; 95% CI 0.64-0.94) and improving QoL (MD -13.3; 95% CI -23.93 to -2.67) and smell (MD +0.7; 95% CI -0.48 to +1.88), with increased TAEs (RR 1.64; 95% CI 0.41-6.50). The evidence for reslizumab is very uncertain.
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http://dx.doi.org/10.1111/all.14809DOI Listing
August 2021

Efficacy of dupilumab in patients with a history of prior sinus surgery for chronic rhinosinusitis with nasal polyps.

Int Forum Allergy Rhinol 2021 Jul 21;11(7):1087-1101. Epub 2021 Feb 21.

Sanofi Genzyme, Reading, UK.

Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a type 2 inflammatory disease treated with sinus surgery when refractory to medical intervention. However, recurrence postsurgery is common. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor for interleukin 4 (IL-4) and IL-13, key and central drivers of type 2 inflammation. We report the efficacy of dupilumab in patients with CRSwNP from the SINUS-24/SINUS-52 trials (NCT02912468/NCT02898454), by number of prior surgeries and time since last surgery.

Methods: Patients were randomized to placebo or dupilumab 300 mg every 2 weeks. Post hoc subgroup analyses were performed for patients with 0, ≥1, 1/2, or ≥3 prior surgeries, and for patients who had surgery within <3, 3 to <5, 5 to <10, or ≥10 years. Efficacy outcomes at 24 weeks included co-primary endpoints nasal polyp score (NPS) and nasal congestion (NC), and Lund-Mackay (LMK), 22-item Sino-Nasal Outcome Test (SNOT-22), and smell scores.

Results: Of 724 patients randomized, 459 (63.4%) had ≥1 prior surgery. Baseline sinus disease (NPS, NC, LMK) and olfactory dysfunction (University of Pennsylvania Smell Identification Test [UPSIT] and loss of smell) scores were worse for patients with ≥3 prior surgeries vs no surgery. Baseline NPS and LMK were worse in patients with <3 years since last surgery than in patients with ≥5 years since last surgery. Dupilumab significantly improved all outcome measures vs placebo in all subgroups by number of surgeries and by time since last surgery. Improvements in NPS and LMK were greater in patients with <3 years since last surgery than patients with ≥5 years. Safety results were consistent with the known dupilumab safety profile.

Conclusion: Dupilumab improved CRSwNP outcomes irrespective of surgery history, with greater improvements in endoscopic outcomes in patients with shorter duration since last surgery.
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http://dx.doi.org/10.1002/alr.22780DOI Listing
July 2021

Six-Month Psychophysical Evaluation of Olfactory Dysfunction in Patients with COVID-19.

Chem Senses 2021 01;46

Guy's and St Thomas' Hospitals, London, United Kingdom.

This study prospectively assessed the 6-month prevalence of self-reported and psychophysically measured olfactory dysfunction in subjects with mild-to-moderate COVID-19. Self-reported smell or taste impairment was prospectively evaluated by SNOT-22 at diagnosis, 4-week, 8-week, and 6-month. At 6 months from the diagnosis, psychophysical evaluation of olfactory function was also performed using the 34-item culturally adapted University of Pennsylvania Smell Identification Test (CA-UPSIT). 145 completed both the 6-month subjective and psychophysical olfactory evaluation. According to CA-UPSIT, 87 subjects (60.0%) exhibited some smell dysfunction, with 10 patients being anosmic (6.9%) and seven being severely microsmic (4.8%). At the time CA-UPSIT was administered, a weak correlation was observed between the self-reported alteration of the sense of smell or taste and olfactory test scores (Spearman's r = -0.26). Among 112 patients who self-reported normal sense of smell at last follow-up, CA-UPSIT revealed normal smell in 46 (41.1%), mild microsmia in 46 (41.1%), moderate microsmia in 11 (9.8%), severe microsmia in 3 (2.3%), and anosmia in 6 (5.4%) patients; however, of those patients self-reporting normal smell but who were found to have hypofunction on testing, 62 out of 66 had a self-reported reduction in sense of smell or taste at an earlier time point. Despite most patients report a subjectively normal sense of smell, we observed a high percentage of persistent smell dysfunction at 6 months from the diagnosis of syndrome coronavirus 2 (SARS-CoV-2) infection, with 11.7% of patients being anosmic or severely microsmic. These data highlight a significant long-term rate of smell alteration in patients with previous SARS-COV-2 infection.
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http://dx.doi.org/10.1093/chemse/bjab006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7929204PMC
January 2021

In the emerging evidence base on coronavirus disease 2019 and loss of smell, how many preprint papers are subsequently published?

Int Forum Allergy Rhinol 2021 07 4;11(7):1128-1131. Epub 2021 Feb 4.

Guy's Hospital, Guy's and St Thomas National Health Service (NHS) Foundation Trust, London, UK.

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http://dx.doi.org/10.1002/alr.22772DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8013438PMC
July 2021

Maximising recruitment to a randomised controlled trial for chronic rhinosinusitis using qualitative research methods: the MACRO conversation study.

Trials 2021 Jan 13;22(1):54. Epub 2021 Jan 13.

Guy's and St. Thomas, NHS Foundation Trust, London, UK.

Background: Randomised controlled trials (RCTs) are considered the 'gold standard' of medical evidence; however, recruitment can be challenging. The MACRO trial is a NIHR-funded RCT for chronic rhinosinusitis (CRS) addressing the challenge of comparing surgery, antibiotics and placebo. The embedded MACRO conversation study (MCS) used qualitative research techniques pioneered by the University of Bristol QuinteT team to explore recruitment issues during the pilot phase, to maximise recruitment in the main trial.

Methods: Setting: Five outpatient Ear Nose and Throat (ENT) departments recruiting for the pilot phase of the MACRO trial (ISRCTN Number: 36962030, prospectively registered 17 October 2018). We conducted a thematic analysis of telephone interviews with 18 recruiters and 19 patients and 61 audio-recordings of recruitment conversations. We reviewed screening and recruitment data and mapped patient pathways at participating sites. We presented preliminary findings to individual site teams. Group discussions enabled further exploration of issues, evolving strategies and potential solutions. Findings were reported back to the funder and used together with recruitment data to justify progression to the main trial.

Results: Recruitment in the MACRO pilot trial began slowly but accelerated in time to progress successfully to the main trial. Research nurse involvement was pivotal to successful recruitment. Engaging the wider network of clinical colleagues emerged as an important factor, ensuring the patient pathway through primary and secondary care did not inadvertently affect trial eligibility. The most common reason for patients declining participation was treatment preference. Good patient-clinician relationships engendered trust and supported patient decision-making. Overall, trial involvement appeared clearly presented by recruiters, possibly influenced by pre-trial training. The weakest area of understanding for patients appeared to be trial medications. A clear presentation of medical and surgical treatment options, together with checking patient understanding, had the potential to allay patient concerns.

Conclusion: The MACRO conversation study contributed to the learning process of optimising recruitment by helping to identify and address recruitment issues. Although some issues were trial-specific, others have applicability to many clinical trial situations. Using qualitative research techniques to identify/explore barriers and facilitators to recruitment may be valuable during the pilot phase of many RCTs including those with complex designs.
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http://dx.doi.org/10.1186/s13063-020-04993-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7805190PMC
January 2021

Severity of Anosmia as an Early Symptom of COVID-19 Infection May Predict Lasting Loss of Smell.

Front Med (Lausanne) 2020 24;7:582802. Epub 2020 Nov 24.

COVID-19 Task Force of the Young-Otolaryngologists of the International Federations of Oto-rhino-laryngological Societies (YO-IFOS), Paris, France.

To evaluate the recovery rate of loss of smell (LOS) with objective olfactory testing in COVID-19 patients. Adults with confirmed COVID-19 and self-reported sudden LOS were prospectively recruited through a public call from the University of Mons (Belgium). Epidemiological and clinical data were collected using online patient-reported outcome questionnaires. Patients benefited from objective olfactory evaluation (Sniffin-Sticks-test) and were invited to attend for repeated evaluation until scores returned to normal levels. From March 22 to May 22, 2020, 88 patients with sudden-onset LOS completed the evaluations. LOS developed after general symptoms in 44.6% of cases. Regarding objective evaluation, 22 patients (25.0%) recovered olfaction within 14 days following the onset of LOS. The smell function recovered between the 16th and the 70th day post-LOS in 48 patients (54.5%). At the time of final assessment at 2 months, 20.5% of patients ( = 18) had not achieved normal levels of olfactory function. Higher baseline severity of olfactory loss measured using Sniffin-Sticks was strongly predictive of persistent loss ( < 0.001). In the first 2 months, 79.5% of patients may expect to have complete recovery of their olfactory function. The severity of olfactory loss, as detected at the first Sniffin-Sticks-test, may predict the lack of mid-term recovery.
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http://dx.doi.org/10.3389/fmed.2020.582802DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7732577PMC
November 2020

Evaluation of Smoking as a Modifying Factor in Chronic Rhinosinusitis.

JAMA Otolaryngol Head Neck Surg 2021 02;147(2):159-165

James Paget University Hospital National Health Service (NHS) Foundation Trust, Gorleston, England.

Importance: The negative association of smoking with the respiratory tract is well known; however, the association between smoking and chronic rhinosinusitis (CRS) has not been well characterized.

Objective: To analyze whether active smoking was a risk factor for CRS development, smoking was associated with disease-specific quality of life, and smokers experience an increased symptom burden than nonsmokers.

Design, Setting, And Participants: This subanalysis of the Chronic Rhinosinusitis Epidemiology Study (CRES), a prospective, questionnaire-based case-control study conducted between October 2007 and September 2013 was conducted across 30 UK tertiary/secondary care sites. Participants were identified at ear, nose, and throat outpatient clinics and classified into CRS phenotypes as per European Position Paper on Rhinosinusitis and Nasal Polyps 2012 criteria. The overall response rate of those identified to take part in the study was 66%. A total of 1535 questionnaires were returned, with 1470 considered eligible for inclusion. Data analysis was conducted in January 2020.

Main Outcomes And Measures: The CRES was designed to distinguish differences in socioeconomic status, geography, medical comorbidities, lifestyle, and quality of life between patients with CRS and healthy controls.

Results: A total of 1450 patients completed the smoking question, comprising 219 controls (15.1%; mean [SD] age, 47.3 [14.9] years; 143 women [68%]), 546 participants with CRS (37.7%; mean [SD] age, 51.8 [15.3] years; 259 women [53%]) without nasal polyps (CRSsNPs), and 685 participants (47.2%; mean [SD] age, 56.0 [14.5] years; 204 women [33%]) with CRS and nasal polyps/allergic fungal rhinosinusitis (CRSwNPs+). The mean age was similar, with a greater female preponderance in the control group and male in the CRSwNP group. The greatest number of active smokers was found among control participants (33 [15%]), with a lower rate of smokers in the patients with CRSwNPs+ (9.9%) and CRSsNPs (13.9%), respectively. We found a clinically significant difference in the mean difference in Sino-nasal Outcome Test (SNOT-22) scores between active smokers and nonsmokers for both CRS phenotypes (4.49, 12.25). In both CRS subgroups active smokers had significantly worse SNOT-22 scores than nonsmokers by a mean (SD) magnitude of 10 (18.99, 24.14) points. Nonsmokers also demonstrated a higher percentage of surgical procedures (1 or more), although this was not clinically or statistically different (0.34, 1.10).

Conclusions And Relevance: This questionnaire-based case-control study demonstrated a clinically significant symptom burden associated with active cigarette smoking, with worse SNOT-22 scores in the smoking cohort by a mean magnitude of 10 points. We could find no demonstrable evidence that smoking increases the likelihood of need for revision sinus surgery. Clinicians should encourage smoking cessation alongside general CRS medical management.
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http://dx.doi.org/10.1001/jamaoto.2020.4354DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7729579PMC
February 2021

More that ACE2? NRP1 may play a central role in the underlying pathophysiological mechanism of olfactory dysfunction in COVID-19 and its association with enhanced survival.

Med Hypotheses 2021 Jan 20;146:110406. Epub 2020 Nov 20.

COVID-19 Task Force of the Young-Otolaryngologists of the International Federations of Oto-rhino-laryngological Societies (YO-IFOS), Paris, France; Department of Human Anatomy and Experimental Oncology, Faculty of Medicine, UMONS Research Institute for Health Sciences and Technology, University of Mons (UMons), Mons, Belgium; Department of Otorhinolaryngology and Head and Neck Surgery, CHU Saint-Pierre, School of Medicine, CHU de Bruxelles, Université Libre de Bruxelles, Brussels, Belgium.

Three mechanisms have been proposed to account for COVID-19 associated olfactory dysfunction; obstruction of the olfactory cleft; epithelial injury and infection of the sustentacular supporting cells, which are known to express ACE2, or injury to the olfactory bulb due to axonal transport through olfactory sensory neurones. The absence of ACE2 expression by olfactory sensory neurones has led to the neurotropic potential of COVID-19 to be discounted. While an accumulating body of evidence supports olfactory epithelial injury as an important mechanism, this does not account for all the features of olfactory dysfunction seen in COVID-19; for example the duration of loss in some patients, evidence of changes within the olfactory bulb on MRI imaging, identification of viral particles within the olfactory bulb in post-mortem specimens and the inverse association between severity of COVID-19 and the prevalence of olfactory loss. The recent identification of a second route of viral entry mediated by NRP1 addresses many of these inconsistencies. Expression by the olfactory sensory neurones and their progenitor cells may facilitate direct injury and axonal transport to the olfactory bulb as well as a mechanism for delayed or absent recovery. Expression by regulatory T cells may play a central role in the cytokine storm. Variability in expression by age, race or gender may explain differing morbidity of infection and inverse association between anosmia and severity; in the case of higher expression there may be a higher risk of olfactory function but greater activation of regulatory T cells that may suppress the cytokine storm.
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http://dx.doi.org/10.1016/j.mehy.2020.110406DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7678428PMC
January 2021

International consensus statement on allergy and rhinology: rhinosinusitis 2021.

Int Forum Allergy Rhinol 2021 Mar;11(3):213-739

Rutgers New Jersey Medical School, Newark, NJ.

I.

Executive Summary: BACKGROUND: The 5 years since the publication of the first International Consensus Statement on Allergy and Rhinology: Rhinosinusitis (ICAR-RS) has witnessed foundational progress in our understanding and treatment of rhinologic disease. These advances are reflected within the more than 40 new topics covered within the ICAR-RS-2021 as well as updates to the original 140 topics. This executive summary consolidates the evidence-based findings of the document.

Methods: ICAR-RS presents over 180 topics in the forms of evidence-based reviews with recommendations (EBRRs), evidence-based reviews, and literature reviews. The highest grade structured recommendations of the EBRR sections are summarized in this executive summary.

Results: ICAR-RS-2021 covers 22 topics regarding the medical management of RS, which are grade A/B and are presented in the executive summary. Additionally, 4 topics regarding the surgical management of RS are grade A/B and are presented in the executive summary. Finally, a comprehensive evidence-based management algorithm is provided.

Conclusion: This ICAR-RS-2021 executive summary provides a compilation of the evidence-based recommendations for medical and surgical treatment of the most common forms of RS.
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http://dx.doi.org/10.1002/alr.22741DOI Listing
March 2021

EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: Definitions and management.

J Allergy Clin Immunol 2021 01 20;147(1):29-36. Epub 2020 Nov 20.

Department of Otorhinolaryngology, Head and Neck Surgery, University Hospitals Leuven, Leuven, Belgium.

Uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) is the most bothersome phenotype of chronic rhinosinusitis; it is typically characterized by a type 2 inflammatory reaction and by comorbidities, including asthma, nonsteroidal anti-inflammatory drug-exacerbated respiratory disease, and allergies. Here, the European Forum for Research and Education in Allergy and Airway Diseases proposes structured definitions to enable communication between clinicians and provides a practical algorithm to define type 2 inflammation in CRSwNP in daily clinical practice. A rational approach for the treatment of uncontrolled severe CRSwNP is discussed; it consists of evaluating the perspective and risks of surgery and efficacy and adverse events of biologics on the basis of currently available data. Further, possible combinations of surgery and biologics are discussed, and a rationale is provided. Here, it is of importance to adequately counsel the patient about both approaches to enable a decision-making process with an informed patient. Criteria for the selection of a biologic drug are provided, as several biologics for uncontrolled severe CRSwNP will be available in many countries within a short time. Further, suggestions for monitoring of the drug effects that support recognition of responders to the therapy and, subsequently, the decision regarding continuation or discontinuation of the biologic are proposed.
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http://dx.doi.org/10.1016/j.jaci.2020.11.013DOI Listing
January 2021

Understanding COVID-19-Related Olfactory Dysfunction-Reply.

JAMA Otolaryngol Head Neck Surg 2021 01;147(1):109-110

Guy's and St Thomas' Hospitals, London, United Kingdom.

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http://dx.doi.org/10.1001/jamaoto.2020.4272DOI Listing
January 2021

Use of Nonmedicated Control Substances in Randomized Clinical Trials of Patients With Chronic Rhinosinusitis: A Systematic Review and Single-Arm Meta-analysis.

JAMA Otolaryngol Head Neck Surg 2021 02;147(2):123-133

ENT Department, Guy's Hospital, London, United Kingdom.

Importance: The effect of nonmedicated control substances in chronic rhinosinusitis remains unclear.

Objective: To assess the association of nonmedicated control substances in randomized clinical trials with disease outcomes in patients diagnosed with chronic rhinosinusitis.

Data Sources And Study Selection: In this single-arm systematic review and meta-analysis, the Cochrane Library of Systematic Reviews, Ovid MEDLINE, Embase, PubMed, and ClinicalTrials.gov databases were searched for randomized clinical trials with a preintervention and postintervention design for chronic rhinosinusitis that were published between 1946 and January 23, 2019.

Data Extraction And Synthesis: Paired reviewers independently extracted data. The analyses used random-effects models and the Cochrane risk of bias assessment to rate the quality of the evidence.

Main Outcomes And Measures: The primary outcomes were the association of nonmedicated control substances with 22-item Sinonasal Outcome Test (SNOT-22) scores or nasal symptom scores when SNOT-22 was not available.

Results: A total of 2305 abstracts were identified and screened, 725 articles were reviewed in full text, and 38 articles met the study criteria and were included in the meta-analysis. Among the 38 included studies, a total of 2258 adults (mean age range, 27-53 years; 20.0%-72.5% women) were randomized to receive nonmedicated control substances or sham interventions. Topical nonmedicated control substances were associated with significant reduction in SNOT-22 scores (mean difference [MD], -8.81; 95% CI, -12.60 to -5.03). A subgroup analysis of topical therapies, limited to saline irrigation and nasal spray diluents, found that topical diluents were associated with a greater reduction in SNOT-22 scores (MD, -11.45; 95% CI, -13.50 to -9.41) compared with saline irrigation (MD, -13.60; 95% CI, -19.95 to -7.25). Nonmedicated control substances were associated with a significant reduction in nasal obstruction scores (standardized MD [SMD], -0.42; 95% CI, -0.81 to -0.03). No significant change was found in rhinorrhea scores (SMD, -0.34; 95% CI, -1.37 to 0.69), postnasal drip scores (SMD, -0.96; 95% CI, -2.18 to 0.25), facial pain scores (SMD, -0.57; 95% CI, -1.68 to 0.55), or loss of smell scores (SMD, -0.18; 95% CI, -0.68 to 0.32).

Conclusions And Relevance: This systematic review and meta-analysis of the use of nonmedicated control substances in randomized clinical trials of chronic rhinosinusitis outcomes suggests that the use of nonmedicated control substances is associated with limited improvements in SNOT-22 and nasal obstruction scores. These findings highlight potential areas of future research directions and the importance of randomized clinical trials to accurately estimate treatment effect.
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http://dx.doi.org/10.1001/jamaoto.2020.3723DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7662504PMC
February 2021

Widespread smell testing for COVID-19 has limited application.

Lancet 2020 11 3;396(10263):1630. Epub 2020 Nov 3.

School of Advanced Study, University of London, London, UK.

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http://dx.doi.org/10.1016/S0140-6736(20)32317-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7834025PMC
November 2020

Adult chronic rhinosinusitis.

Nat Rev Dis Primers 2020 10 29;6(1):86. Epub 2020 Oct 29.

Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

Chronic rhinosinusitis (CRS) occurs in >10% of the adult population in Europe and the USA and can be differentiated into CRS without nasal polyps and CRS with nasal polyps (CRSwNP). Both phenotypes are characterized by a high disease burden and an overlapping spectrum of symptoms, with facial pain and loss of smell being the most differentiating. Great progress has been made in the understanding of CRS pathophysiology: from the epithelium and epithelial-mesenchymal transition to innate and adaptive immunity pathways and, finally, on the role of eosinophils and Staphylococcus aureus in the persistence of disease. Although clinical manifestations and diagnostic tools (including nasal endoscopy and imaging) have undergone major changes over the past few years, management (including pharmacotherapy, surgery and biologics) has experienced enormous progress based on the growing knowledge of key mediators in severe CRSwNP. The introduction of endotyping has led to a differentiation of 'tailored' surgical approaches, focusing on the mucosal concept in those with severe CRSwNP and on the identification of patients eligible for extended surgery and possibly biologics in the future.
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http://dx.doi.org/10.1038/s41572-020-00218-1DOI Listing
October 2020

Preprints-expediting access or compromising quality?

Authors:
Claire Hopkins

Int Forum Allergy Rhinol 2021 May 13;11(5):835-836. Epub 2020 Nov 13.

Department of Ear, Nose and Throat (ENT), Guy's and St Thomas' National Health Service (NHS) Hospitals, London, UK.

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http://dx.doi.org/10.1002/alr.22732DOI Listing
May 2021