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Warner JO, Warner JA, Munblit D, 2022, Hypotheses to explain the associations between asthma and the consequences of COVID-19 infection., Clinical and Experimental Allergy, Vol: 52, Pages: 7-9, ISSN: 0954-7894
Munblit D, Parr C, Chen J, et al., 2021, Studying the Post-COVID-19 condition: research challenges, strategies and importance of Core Outcome Set development, BMC Medicine, ISSN: 1741-7015
The increasing prevalence of allergic diseases has placed a significant burden on global healthcare and society as whole. This has necessitated a rapid development of "allergy" as a specialist area. However, as allergy is so common and, for most, relatively easy to diagnose and control, all clinicians need to have basic knowledge and competence to manage mild disease and recognize when referral is required. The allergology specialty has not yet been recognized in many countries and even where allergy is fully recognized as a specialty, the approach to training in allergy differs significantly. In the light of recent developments in allergy diagnosis and management, there is an urgent need to harmonize core competences for physicians, as well as the standardization of core principles for medical education and post-graduate training in allergy. All physicians and allied health professionals must appreciate the multidisciplinary team (MDT) approach to allergy, which is key to achieving the highest standards in holistic care. Due to worldwide variation in resources and personnel, some MDT roles will need to be absorbed by the treating physician or other healthcare professionals. We draw particular attention to the role of psychological input for all allergy patients, dietetic input in the case of food allergy and patient education to support all patients in the supported self-management of their condition on a daily basis. A strong appreciation of these multidisciplinary aspects will help physicians provide quality patient-centered care. We consider that harmonization of allergy components within undergraduate curricula is crucial to ensure all physicians develop the appropriate allergy-related knowledge and skills, particularly in light of inconsistencies seen in the primary care management of allergy. This review from the World Allergy Organization (WAO) Education and Training Committee also outlines allergy-related competences required
Daniels L, Barker S, Chang Y-S, et al., 2021, Harmonizing allergy care–integrated care pathways and multidisciplinary approaches, World Allergy Organization Journal, Vol: 14, ISSN: 1939-4551
There is a wide time gap between the publication of evidence and the application of new knowledge into routine clinical practice. The consequence is sub-optimal outcomes, particularly concerning for long-term relapsing/remitting conditions such as allergic diseases. In response, there has been a proliferation of published guidelines which systematically review evidence for the gold-standard management of most allergic disorders. However, this has not necessarily been followed by improved outcomes, partly due to a lack of coordination across the patient pathway. This has become known as the "second translational gap". A proposed solution is the development and implementation of integrated care pathways (ICPs) to optimize patient outcomes, with the notion that evidence-based medicine requires evidence-based implementation. ICP implementation is shown to improve short-term outcomes for acute conditions and routine surgery, including reduced length of hospital stay, improved documentation and improved patient safety. However, this improvement is not reflected in patient experience or patient-centered functional outcomes. The implementation of life-long, cost-effective interventions within comprehensive pathways requires a deep appreciation for complexity within allergy care.We promote an evidence-based methodology for the implementation of ICPs for allergic disorders in which all stakeholders in allergy care are positioned equally and encouraged to contribute, particularly patients and their caregivers. This evidence-based process commences with scoping the unmet needs, followed by stakeholder mapping. All stakeholders are invited to meetings to develop a common vision and mission through the generation of action/effect diagrams which helps build concordance across the agencies. Dividing the interventions into achievable steps and reviewing with plan/do/study/act cycles will gradually modify the pathway to achieve the best outcomes. While the management guidel
Warner JO, 2021, Translating results from research into clinical practice, ARCHIVES OF DISEASE IN CHILDHOOD, ISSN: 0003-9888
Munblit D, Bobkova P, Spiridonova E, et al., 2021, Incidence and risk factors for persistent symptoms in adults previously hospitalized for COVID-19, Clinical and Experimental Allergy, Vol: 51, Pages: 1107-1120, ISSN: 0954-7894
BackgroundThe long-term sequalae of COVID-19 remain poorly characterized. We assessed persistent symptoms in previously hospitalized patients with COVID-19 and assessed potential risk factors.MethodsData were collected from patients discharged from 4 hospitals in Moscow, Russia between 8 April and 10 July 2020. Participants were interviewed via telephone using an ISARIC Long-term Follow-up Study questionnaire.Results2,649 of 4755 (56%) discharged patients were successfully evaluated, at median 218 (IQR 200, 236) days post-discharge. COVID-19 diagnosis was clinical in 1291 and molecular in 1358. Most cases were mild, but 902 (34%) required supplemental oxygen and 68 (2.6%) needed ventilatory support. Median age was 56 years (IQR 46, 66) and 1,353 (51.1%) were women. Persistent symptoms were reported by 1247 (47.1%) participants, with fatigue (21.2%), shortness of breath (14.5%) and forgetfulness (9.1%) the most common symptoms and chronic fatigue (25%) and respiratory (17.2%) the most common symptom categories. Female sex was associated with any persistent symptom category OR 1.83 (95% CI 1.55 to 2.17) with association being strongest for dermatological (3.26, 2.36 to 4.57) symptoms. Asthma and chronic pulmonary disease were not associated with persistent symptoms overall, but asthma was associated with neurological (1.95, 1.25 to 2.98) and mood and behavioural changes (2.02, 1.24 to 3.18), and chronic pulmonary disease was associated with chronic fatigue (1.68, 1.21 to 2.32).ConclusionsAlmost half of adults admitted to hospital due to COVID-19 reported persistent symptoms 6 to 8 months after discharge. Fatigue and respiratory symptoms were most common, and female sex was associated with persistent symptoms.
Munblit D, Sigfrid L, Warner JO, 2021, Setting Priorities to Address Research Gaps in Long-term COVID-19 Outcomes in Children, JAMA PEDIATRICS, Vol: 175, Pages: 1095-1096, ISSN: 2168-6203
Osmanov IM, Spiridonova E, Bobkova P, et al., 2021, Risk factors for long covid in previoulsy hospitalsied children using the ISARIC Global Follow-Up Protocol: a prospective cohort study, European Respiratory Journal, ISSN: 0903-1936
Background The long-term sequelae of coronavirus disease 2019 (Covid-19) in children remain poorly characterised. This study aimed to assess long-term outcomes in children previously hospitalised with Covid-19 and associated risk factors.Methods This is a prospective cohort study of children (≤18 years old) admitted with confirmed Covid-19. Children admitted to the hospital between April 2, 2020 and August 26, 2020, were included. Telephone interview using the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) Covid-19 Health and Wellbeing paediatric follow-up survey. Persistent symptoms (>5 months) were further categorised by system(s) involved.Findings 518 of 853 (61%) of eligible children were available for the follow-up assessment and included in the study. Median age was 10.4 years (IQR, 3–15.2) and 270 (52.1%) were girls; median follow-up since hospital discharge was 256 (223–271) days. At the time of the follow-up interview 126 (24.3%) participants reported persistent symptoms among which fatigue (53, 10.7%), sleep disturbance (36, 6.9%,) and sensory problems (29, 5.6%) were the most common. Multiple symptoms were experienced by 44 (8.4%) participants. Risk factors for persistent symptoms were: older age “6–11 years” (odds ratio 2.74 (95% confidence interval 1.37 to 5.75) and “12–18 years” (2.68, 1.41 to 5.4); and a history of allergic diseases (1.67, 1.04 to 2.67).Interpretation A quarter of children experienced persistent symptoms months after hospitalization with acute covid-19 infection, with almost one in ten experiencing multi-system involvement. Older age and allergic diseases were associated with higher risk of persistent symptoms at follow-up.
Munblit D, Nekliudov NA, Bugaeva P, et al., 2021, StopCOVID cohort: An observational study of 3,480 patients admitted to the Sechenov University hospital network in Moscow city for suspected COVID-19 infection, Clinical Infectious Diseases, Vol: 73, Pages: 1-11, ISSN: 1058-4838
BACKGROUND: The epidemiology, clinical course, and outcomes of COVID-19 patients in the Russian population are unknown. Information on the differences between laboratory-confirmed and clinically-diagnosed COVID-19 in real-life settings is lacking. METHODS: We extracted data from the medical records of adult patients who were consecutively admitted for suspected COVID-19 infection in Moscow, between April 8 and May 28, 2020. RESULTS: Of the 4261 patients hospitalised for suspected COVID-19, outcomes were available for 3480 patients (median age 56 years (interquartile range 45-66). The commonest comorbidities were hypertension, obesity, chronic cardiac disease and diabetes. Half of the patients (n=1728) had a positive RT-PCR while 1748 were negative on RT-PCR but had clinical symptoms and characteristic CT signs suggestive of COVID-19 infection.No significant differences in frequency of symptoms, laboratory test results and risk factors for in-hospital mortality were found between those exclusively clinically diagnosed or with positive SARS-CoV-2 RT-PCR.In a multivariable logistic regression model the following were associated with in-hospital mortality; older age (per 1 year increase) odds ratio [OR] 1.05 (95% confidence interval (CI) 1.03 - 1.06); male sex (OR 1.71, 1.24 - 2.37); chronic kidney disease (OR 2.99, 1.89 - 4.64); diabetes (OR 2.1, 1.46 - 2.99); chronic cardiac disease (OR 1.78, 1.24 - 2.57) and dementia (OR 2.73, 1.34 - 5.47). CONCLUSIONS: Age, male sex, and chronic comorbidities were risk factors for in-hospital mortality. The combination of clinical features were sufficient to diagnoseCOVID-19 infection indicating that laboratory testing is not critical in real-life clinical practice.
Zepeda-Ortega B, Goh A, Xepapadaki P, et al., 2021, Strategies and future opportunities for the prevention, diagnosis, and management of cow milk allergy, Frontiers in Immunology, Vol: 12, ISSN: 1664-3224
The prevalence of food allergy has increased over the last 20-30 years, including cow milk allergy (CMA) which is one of the most common causes of infant food allergy. International allergy experts met in 2019 to discuss broad topics in allergy prevention and management of CMA including current challenges and future opportunities. The highlights of the meeting combined with recently published developments are presented here. Primary prevention of CMA should start from pre-pregnancy with a focus on a healthy lifestyle and food diversity to ensure adequate transfer of inhibitory IgG- allergen immune complexes across the placenta especially in mothers with a history of allergic diseases and planned c-section delivery. For non-breastfed infants, there is controversy about the preventive role of partially hydrolyzed formulae (pHF) despite some evidence of health economic benefits among those with a family history of allergy. Clinical management of CMA consists of secondary prevention with a focus on the development of early oral tolerance. The use of extensive Hydrolysate Formulae (eHF) is the nutrition of choice for the majority of non-breastfed infants with CMA; potentially with pre-, probiotics and LCPUFA to support early oral tolerance induction. Future opportunities are, among others, pre- and probiotics supplementation for mothers and high-risk infants for the primary prevention of CMA. A controlled prospective study implementing a step-down milk formulae ladder with various degrees of hydrolysate is proposed for food challenges and early development of oral tolerance. This provides a more precise gradation of milk protein exposure than those currently recommended.
Munblit D, Simpson F, Mabbitt J, et al., 2021, Legacy of COVID-19 infection in children: long-COVID will have a lifelong health/economic impact, ARCHIVES OF DISEASE IN CHILDHOOD, ISSN: 0003-9888
Chauhan AJ, Brown TP, Storrar W, et al., 2021, Effect of nocturnal Temperature-controlled Laminar Airflow on the reduction of severe exacerbations in patients with severe allergic asthma: a meta-analysis, European Clinical Respiratory Journal, Vol: 8, Pages: 1-9, ISSN: 2001-8525
Background: Allergen avoidance is important in allergic asthma management. Nocturnal treatment with Temperature-controlled Laminar Airflow (TLA) has been shown to provide a significant reduction in the exposure to allergens in the breathing zone, leading to a long-term reduction in airway inflammation and improvement in Quality of life (QoL). Allergic asthma patients symptomatic on Global Initiative for Asthma (GINA) step 4/5 were found to benefit the most as measured by Asthma Quality of Life Questionnaire (AQLQ). However, the effect of TLA on severe asthma exacerbations is uncertain and therefore a meta-analysis was performed.Methods: Patients with severe allergic asthma (GINA 4/5) were extracted from two 1-year randomised, double-blind, placebo-controlled trials conducted with TLA. A meta-analysis of the effect on severe exacerbations was performed by negative binomial regression in a sequential manner, defined by baseline markers of asthma control (symptoms and QoL scores).Results: The pooled dataset included 364patients. Patients with more symptoms at baseline (ACT<18 or ACQ7>3; N=179), had a significant mean 41% reduction in severe exacerbations (RR=0.59 (0.38-0.90); p=0.015) in favour of TLA. Higher ACQ7 cut-points of 3.5-4.5 resulted in significant reductions of 48-59%.More uncontrolled patients based on AQLQ total and symptom domains ≤3.0 at baseline also showed a significant reduction in severe exacerbations for TLA vs. placebo ((47% (p=0.037) and 53% (p=0.011), respectively). The meta-analysis also confirmed a significant difference in AQLQ-responders ((Minimal Clinically Important Difference)≥0.5; 74% vs. 43%, p=0.04).Conclusion: This meta-analysis of individual patient data shows a beneficial effect on severe exacerbations and quality of life for TLA over placebo in more symptomatic patients with severe allergic asthma. These outcomes support the national management recommendations for patients with symptomatic severe allergic asthma. The ac
Munblit D, Bobkova P, Spiridonova E, et al., 2021, Risk factors for long-term consequences of COVID-19 in hospitalised adults in Moscow using the ISARIC Global follow-up protocol: StopCOVID cohort study
<jats:title>ABSTRACT</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>The long-term sequalae of COVID-19 remain poorly characterised. In this study, we aimed to assess long-standing symptoms (LS) (symptoms lasting from the time of discharge) in previously hospitalised patients with COVID-19 and assess associated risk factors.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>This is a longitudinal cohort study of adults (≥18 years of age) with clinically diagnosed or laboratory-confirmed COVID-19 admitted to Sechenov University Hospital Network in Moscow, Russia. Data were collected from patients discharged between April 8 and July 10, 2020. Participants were interviewed via telephone using Tier 1 ISARIC Long-term Follow-up Study CRF and the WHO CRF for Post COVID conditions. Reported symptoms were further categorised based on the system(s) involved. Additional information on dyspnoea, quality of life and fatigue was collected using validated instruments. Multivariable logistic regressions were performed to investigate risk factors for development of LS categories.</jats:p></jats:sec><jats:sec><jats:title>Findings</jats:title><jats:p>Overall, 2,649 of 4,755 patients discharged from the hospitals were available for the follow-up and included in the study. The median age of the patients was 56 years (IQR, 46–66) and 1,353 (51.1%) were women. The median follow-up time since hospital discharge was 217.5 (200.4-235.5) days. At the time of the follow-up interview 1247 (47.1%) participants reported LS. Fatigue (21.2%, 551/2599), shortness of breath (14.5%, 378/2614) and forgetfulness (9.1%, 237/2597) were the most common LS reported. Chronic fatigue (25%, 658/2593) and respiratory (17.2% 451/2616) were the most common LS categories. with reporting of multi-system involvement (MSI) less common (11.3%; 299). Female sex was as
Warner JO, Green RJ, Mustafa F, 2020, Allergy prevention – Reality or not?, Current Allergy and Clinical Immunology, Vol: 33, Pages: 130-137, ISSN: 1609-3607
While the epidemic of respiratory allergy (asthma and rhinitis) which began 50-60 years ago has begun to taper off in some parts of the world, most notably in affluent countries, a second wave involving food allergy and atopic dermatitis is in full swing. Once established allergic diseases, while episodic with changing manifestations over time, last for decades and are often lifelong. The number of lives affected and the quality of life implications mandates investigation of interventions to mitigate these conditions which together constitute the commonest long-term disorders to affect young people. The health economic burden of allergic diseases is considerable and as new biological therapies are approved this will only increase. The search for a cure has hitherto been fruitless but there is the hope that by understanding basic mechanisms it will eventually be possible to design targeted biological therapies to switch off the allergic process. However, this is an expensive enterprise and the costs of curative treatment may well be prohibitive. Prevention has become a focus for many long-term conditions and allergic disease must be included given the potential that strategies will confer considerable health/economic benefits. Health promotion which emphasises avoidance of environmental tobacco smoke, alcohol, pollution and obesity with promotion of exercise, and a nutritious diet has implications for allergic disease as well as the usual focus on cardio-vascular disease, cancer and metabolic syndrome. There are four potential 'windows of opportunity' in early life which impact on the genetic potential to develop allergy in young children. They are in line with the developmental origins of health and disease hypothesis often now known as the ifrst 1 000 days from conception to the second birthday. Published studies of factors influencing the ontogeny and prevention of allergy have shown very different outcomes which makes careful attention to design a
Renedo A, Miles S, Chakravorty S, et al., 2020, Understanding the health-care experiences of people with sickle cell disorder transitioning from paediatric to adult services: This Sickle Cell Life, a longitudinal qualitative study, Health Services and Delivery Research, Vol: 8, Pages: 1-118, ISSN: 2050-4349
BackgroundTransitions from paediatric to adult health-care services cause problems worldwide, particularly for young people with long-term conditions. Sickle cell disorder brings particular challenges needing urgent action.ObjectivesUnderstand health-care transitions of young people with sickle cell disorder and how these interact with broader transitions to adulthood to improve services and support.MethodsWe used a longitudinal design in two English cities. Data collection included 80 qualitative interviews with young people (aged 13–21 years) with sickle cell disorder. We conducted 27 one-off interviews and 53 repeat interviews (i.e. interviews conducted two or three times over 18 months) with 48 participants (30 females and 18 males). We additionally interviewed 10 sickle cell disease specialist health-care providers. We used an inductive approach to analysis and co-produced the study with patients and carers.ResultsKey challenges relate to young people’s voices being ignored. Participants reported that their knowledge of sickle cell disorder and their own needs are disregarded in hospital settings, in school and by peers. Outside specialist services, health-care staff refuse to recognise patient expertise, reducing patients’ say in decisions about their own care, particularly during unplanned care in accident and emergency departments and on general hospital wards. Participants told us that in transitioning to adult care they came to realise that sickle cell disorder is poorly understood by non-specialist health-care providers. As a result, participants said that they lack trust in staff’s ability to treat them correctly and that they try to avoid hospital. Participants reported that they try to manage painful episodes at home, knowing that this is risky. Participants described engaging in social silencing (i.e. reluctance to talk about and disclose their condition for fear that others will not listen or will not understand) outside hospi
Boyle R, Brown N, Chiang WC, et al., 2020, Partially hydrolysed, prebiotic supplemented whey formula for the prevention of allergic manifestations in high risk infants: a multicentre double-blind randomised controlled trial (Retraction of Vol 5, art no P30, 2015), Clinical and Translational Allergy, Vol: 10, ISSN: 2045-7022
Munblit D, Warner J, Tudor-Williams G, et al., 2020, Excessive media consumption about COVID-19 is associated with increased state anxiety: Outcomes of a large online survey in Russia, Journal of Medical Internet Research, Vol: 22, Pages: 1-18, ISSN: 1438-8871
Background: The coronavirus disease 2019 (COVID-19) pandemic has potentially had a negative impact on the mental health and well being of individuals and families. Anxiety levels and risk factors within particular populations are poorly described.Objectives: To evaluate confidence, understanding, trust and concerns and levels of anxiety during COVID-19 pandemic in general population and assess risk factors for increased anxiety.Methods: We launched a cross-sectional online survey a large Russian population between 6th and 15th April 2020 using multiple social media platforms. A set of questions targeted confidence, understanding, trust and concerns in respondents. State-Trait Anxiety Inventory (STAI) was used to measure anxiety. Multiple linear regressions were used to model predictors of COVID-19 related anxiety.Results: The survey was completed by 23,756 out of 53,966 unique visitors (44.0% response rate); 21,364 of who were residing in 62 areas of Russia. State anxiety (S-Anxiety) scores were higher than Trait anxiety (T-Anxiety) across all regions of Russia (median S-Anxiety score 52 [IQR 44-60]), exceeding published norms. Time spent following news on COVID-19 was strongly associated with an increased S-Anxiety adjusted for baseline anxiety level. One to two hours spent reading COVID news was associated with 5.46 (95%CI 5.03-5.90) point difference, 2-3 hours 7.06 (6.37-7.74) and more than three hours 8.65 (7.82-9.47), respectively; all compared to less than 30 minutes per day. Job loss during pandemic was another important factor associated with higher S-Anxiety scores (3.95 [3.31 – 4.58]).Despite survey respondents reporting high confidence in information regarding COVID-19, as well as understanding of healthcare guidance, they reported low overall trust in state and local authorities and perception of country readiness.Conclusions: Among Russian respondents from multiple social media platforms, there is evidence of higher levels of state-anxiety asso
Warner JO, 2020, Asthma/Rhinitis (The United Airway) and allergy: chicken or egg; which comes first?, Journal of Clinical Medicine, Vol: 9, Pages: 1-11, ISSN: 2077-0383
While allergy, asthma and rhinitis do not inevitably co-exist, there are strong associations. Not all those with asthma are allergic, rhinitis may exist without asthma, and allergy commonly exists in the absence of asthma and/or rhinitis. This is likely due to the separate gene/environment interactions which influence susceptibility to allergic sensitization and allergic airway diseases. Allergic sensitization, particularly to foods, and eczema commonly manifest early in infancy, and not infrequently are followed by the development of allergic rhinitis and ultimately asthma. This has become known as the "allergic march". However, many infants with eczema never develop asthma or rhinitis, and both the latter conditions can evolve without prior eczema or food allergy. Understanding the mechanisms underlying the ontogeny of allergic sensitization and allergic disease will facilitate rational approaches to the prevention and management of asthma and allergic rhinitis. Furthermore, a range of new, so-called biological, therapeutic approaches, targeting specific allergy-promoting and pro-inflammatory molecules, are now in clinical trials or have been recently approved for use by regulatory authorities and could have a major impact on disease prevention and control in the future. Understanding basic mechanisms will be essential to the employment of such medications. This review will explain the concept of the united airway (rhinitis/asthma) and associations with allergy. It will incorporate understanding of the role of genes and environment in relation to the distinct but interacting origins of allergy and rhinitis/asthma. Understanding the patho-physiological differences and varying therapeutic requirements in patients with asthma, with or without rhinitis, and with or without associated allergy, will aid the planning of a personalized evidence-based management strategy.
Jarrold K, Helfer B, Eskander M, et al., 2020, Guidance for the conduct and reporting of clinical trials of breast milk substitutes., JAMA Pediatrics, ISSN: 2168-6203
Importance: Breast milk substitutes (BMS) are important nutritional products evaluated in clinical trials. Concerns have been raised about the risk of bias in BMS trials, the reliability of claims that arise from such trials, and the potential for BMS trials to undermine breastfeeding in trial participants. Existing clinical trial guidance does not fully address issues specific to BMS trials. Objectives: To establish new methodological criteria to guide the design, conduct, analysis, and reporting of BMS trials and to support clinical trialists designing and undertaking BMS trials, editors and peer reviewers assessing trial reports for publication, and regulators evaluating the safety, nutritional adequacy, and efficacy of BMS products. Design, Setting, and Participants: A modified Delphi method was conducted, involving 3 rounds of anonymous questionnaires and a face-to-face consensus meeting between January 1 and October 24, 2018. Participants were 23 experts in BMS trials, BMS regulation, trial methods, breastfeeding support, infant feeding research, and medical publishing, and were affiliated with institutions across Europe, North America, and Australasia. Guidance development was supported by an industry consultation, analysis of methodological issues in a sample of published BMS trials, and consultations with BMS trial participants and a research ethics committee. Results: An initial 73 criteria, derived from the literature, were sent to the experts. The final consensus guidance contains 54 essential criteria and 4 recommended criteria. An 18-point checklist summarizes the criteria that are specific to BMS trials. Key themes emphasized in the guidance are research integrity and transparency of reporting, supporting breastfeeding in trial participants, accurate description of trial interventions, and use of valid and meaningful outcome measures. Conclusions and Relevance: Implementation of this guidance should enhance the quality and validity of BMS trials, prot
Jarrold K, Helfer B, Eskander M, et al., 2019, Guidance for the conduct and reporting of clinical trials of breastmilk substitutes: a Delphi consensus statement, JAMA Pediatrics, ISSN: 2168-6203
Importance: Breastmilk substitutes (BMS) are important nutritional products evaluated in clinical trials. Concerns have been raised about the risk of bias in BMS trials, the reliability of claims which arise from such trials, and the potential for BMS trials to undermine breastfeeding in trial participants. Existing clinical trial guidance68 does not fully address issues specific to BMS trials. Objective: To establish new methodological criteria to guide the design, conduct, analysis and reporting of BMS trials. To support clinical trialists designing and undertaking BMS trials, editors and peer reviewers assessing trial reports for publication, and regulators evaluating the safety, nutritional adequacy and efficacy of BMS products. Design, Setting, and Participants A modified Delphi method involving 3 rounds of anonymous questionnaires and a face-to-face consensus meeting between January and October 2018. Participants were 23 experts in BMS trials, BMS regulation, trial methodology, breastfeeding support, infant feeding research and medical publishing, affiliated with institutions across Europe, North America and Australasia. Guidance development was supported by an industry consultation, analysis of methodological issues in a sample of published BMS trials, and consultations with BMS trial 81 participants and a research ethics committee. Results: An initial 73 criteria, derived from the literature, were sent to the experts. The final consensus guidance contains a total of 54 essential and 4 recommended criteria. An 18-point checklist summarizes those criteria which are specific to BMS 5 trials. Key themes emphasised in the guidance are research integrity and transparency of reporting, supporting breastfeeding in trial participants, accurate description of trial interventions and use of valid and meaningful outcome measures. Conclusions and Relevance: Implementation of this guidance should enhance the quality and validity of BMS trials, protect BMS trial particip
Renedo A, Miles S, Chakravorty S, et al., 2019, Not being heard: barriers to high quality unplanned hospital care during young people's transition to adult services - evidence from 'this sickle cell life' research, BMC Health Services Research, Vol: 19, ISSN: 1472-6963
BACKGROUND: Young people's experiences of healthcare as they move into adult services can have a major impact on their health, and the transition period for young people with sickle cell disease (SCD) needs improvement. In this study, we explore how young people with SCD experience healthcare during this period of transition. METHODS: We conducted a co-produced longitudinal qualitative study, including 80 interviews in 2016-2017 with young people with SCD aged 13-21 (mean age 16.6) across two cities in England. We recruited 48 participants (30 female, 18 male): 27 interviews were one-off, and 53 were repeated 2-3 times over approximately 18 months. We used an inductive analytical approach, combining elements of Grounded Theory and thematic analysis. RESULTS: Participants reported significant problems with the care they received in A&E during painful episodes, and in hospital wards as inpatients during unplanned healthcare. They experienced delays in being given pain relief and their basic care needs were not always met. Participants said that non-specialist healthcare staff did not seem to know enough about SCD and when they tried to work with staff to improve care, staff often seemed not prepared to listen to them or act on what they said. Participants said they felt out of place in adult wards and uncomfortable with the differences in adult compared with paediatric wards. Because of their experiences, they tried to avoid being admitted to hospital, attempting to manage their painful episodes at home and accessing unplanned hospital care only as a last resort. By contrast, they did not report having problems within SCD specialist services during planned, routine care. CONCLUSIONS: Our study underscores the need for improvements to make services youth-friendly and youth-responsive, including training staff in SCD-specific care, compassionate care and communication skills that will help them elicit and act on young people's voices to ensure they are involv
Blyuss O, Cheung KY, Chen J, et al., 2019, Statistical approaches in the studies assessing associations between human milk immune composition and allergic diseases: A scoping review, Nutrients, Vol: 11, Pages: 1-15, ISSN: 2072-6643
A growing number of studies are focusing on the associations between human milk (HM) immunological composition and allergic diseases. This scoping review aims to identify statistical methods applied in the field and highlight pitfalls and unmet needs. A comprehensive literature search in MEDLINE and Embase retrieved 13,607 unique records. Following title/abstract screening, 29 studies met the selection criteria and were included in this review. We found that definitions of colostrum and mature milk varied across the studies. A total of 17 out of 29 (59%) studies collected samples longitudinally, but only 12% of these used serial (longitudinal) analyses. Multivariable analysis was used in 45% of the studies, but statistical approaches to modelling varied largely across the studies. Types of variables included as potential confounding factors differed considerably between models. Discrimination analysis was absent from all studies and only a single study reported classification measures. Outcomes of this scoping review highlight lack of standardization, both in data collection and handling, which remains one of the main challenges in the field. Improved standardization could be obtained by a consensus group of researchers and clinicians that could recommend appropriate methods to be applied in future prospective studies, as well as already existing datasets.
Khaleva E, Gridneva Z, Geddes DT, et al., 2019, Transforming growth factor beta in human milk and allergic outcomes in children: A systematic review, Clinical and Experimental Allergy, Vol: 49, Pages: 1201-1213, ISSN: 0954-7894
BACKGROUND: Human milk (HM) transforming growth factor beta (TGF-β) is critical for inflammation regulation and oral tolerance promotion. Previous reports suggested that variations in HM TGF-β levels are associated with allergic outcomes. OBJECTIVE: We undertook a systematic review (PROSPERO 2017 CRD42017069920) to reassess the evidence on the relationships between HM TGF-β and allergic outcomes in children. METHODS: Electronic bibliographic databases (MEDLINE, EMBASE, Cochrane Library) were systematically searched. Two independent reviewers screened reference lists, extracted the data and assessed risk of bias using the National Institute for Clinical Excellence methodological checklist. RESULTS: A total of 21 studies were identified. Sixteen studies assessed relationships between HM TGF-β and risk of eczema; 14, allergic sensitisation; 9, wheezing/asthma; 6, food allergy; 3, allergic rhinitis/conjunctivitis. Five cohorts (5/18, 28%) reported a protective effect of TGF-β1, while 3 (3/10, 30%) suggested increased risk of allergic outcomes development and 1 (1/10, 10%), a protective effect of TGF-β2 on eczema. Meta-analysis was not possible due to significant heterogeneity in methodology, age of outcome assessment and differing statistical approaches. 71% (15/21) of studies carried a high risk of bias. CONCLUSION AND CLINICAL RELEVANCE: In contrast with previous findings we did not find strong evidence of associations between HM TGF-β and allergic outcomes. Differences in studies' methodology and outcomes do not allow unconditional rejection or acceptance of the hypothesis that HM TGF-β influences the risk of allergy development. Future studies on diverse populations employing standardised methods, accurate phenotyping of outcomes and evaluation of the effect of TGF-β in combination with other HM immune markers, microbiome and oligosaccharides are required.
Boix-Amorós A, Collado MC, Van't Land B, et al., 2019, Reviewing the evidence on breast milk composition and immunological outcomes., Nutr Rev
A large number of biologically active components have been found in human milk (HM), and in both human and animal models, studies have provided some evidence suggesting that HM composition can be altered by maternal exposures, subsequently influencing health outcomes for the breastfed child. Evidence varies from the research studies on whether breastfeeding protects the offspring from noncommunicable diseases, including those associated with immunological dysfunction. It has been hypothesized that the conflicting evidence results from HM composition variations, which contain many immune active molecules, oligosaccharides, lactoferrin, and lysozyme in differing concentrations, along with a diverse microbiome. Determining the components that influence infant health outcomes in terms of both short- and long-term sequelae is complicated by a lack of understanding of the environmental factors that modify HM constituents and thereby offspring outcomes. Variations in HM immune and microbial composition (and the differing infantile responses) may in part explain the controversies that are evidenced in studies that aim to evaluate the prevalence of allergy by prolonged and exclusive breastfeeding. HM is a "mixture" of immune active factors, oligosaccharides, and microbes, which all may influence early immunological outcomes. This comprehensive review provides an in-depth overview of existing evidence on the studied relationships between maternal exposures, HM composition, vaccine responses, and immunological outcomes.
Levy ML, Fleming L, Warner JO, et al., 2019, Paediatric asthma care in the UK: fragmented and fatally fallible., British Journal of General Practice, Vol: 69, Pages: 405-406, ISSN: 0960-1643
Munblit D, Verhasselt V, Warner JO, 2019, Editorial: human milk composition and health outcomes in children, Frontiers in Pediatrics, Vol: 7, Pages: 1-3, ISSN: 2296-2360
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In the version of this article initially published, a source of funding was not included in the Acknowledgements section. That section should include the following: P.J.M.O. was supported by EU FP7 PREPARE project 602525. The error has been corrected in the HTML and PDF version of the article.
Bjermer L, Eriksson G, Radner F, et al., 2019, Time to onset of improvements in Quality of Life from Temperature-controlled Laminar Airflow (TLA) in severe allergic asthma, Respiratory Medicine, Vol: 147, Pages: 19-25, ISSN: 0954-6111
BackgroundAllergen avoidance is important in allergic asthma management. Nocturnal treatment with Temperature-controlled Laminar Airflow (TLA; Airsonett®) has been shown to provide significant reduction of exposure to allergens in the breathing zone, leading to long-term reduction in airway inflammation and improvement in quality of life. Allergic asthma patients uncontrolled on GINA step 4 were found to benefit the most. A frequently asked question from clinicians and funders is related to time to onset (TTO) of improvements for patients using TLA.MethodsAsthma Quality of Life Questionnaire (AQLQ) scores were collected in a previous study. TTO of improvements in Quality of Life was analysed for difference (TLA-placebo) in Area-under-Curve using backwards deletion from 12, 9, 6, 3 down to 1 month for the AQLQ total score, the four individual domains and specifically the sleep question.ResultsPatients with uncontrolled asthma on GINA step 4 (n = 87)) reported a statistically significant and clinically relevant (≥0.5 point) improvement in total AQLQ score (0.57; p = 0.009) after 3 months treatment for TLA over placebo. The shortest TTO was within 1 month for the environmental domain (0.68; p = 0.016) and the sleep question (0.771; p = 0.037). TTO for the emotional and symptom domains was 3 months (0.66; p = 0.020 and 0.64; p = 0.014 respectively) and for the activity domain 6 months (0.47; p = 0.036).ConclusionNocturnal avoidance of allergens using TLA provided a statistically significant and clinically relevant improvement in total AQLQ score within 3 months in patients in the GINA 4 + ACT<18 group. Questions related to sleep quality may provide the first signal of response already within a month after commencing treatment.
Chakravorty S, Tallett A, Sathyamoorthy G, et al., 2018, Patient reported experience measure in Sickle Cell disease, Archives of Disease in Childhood, Vol: 103, Pages: 1104-1109, ISSN: 1468-2044
Objectives:To develop Patient Reported Experience Measure surveys for patients with Sickle CellDisease (SCD) to understand their healthcare and lived experience in the UK and fortheir use in future to inform healthcare service development.Design:Picker methodology was used as follows:1. Qualitative scoping by focus group discussions2. Questionnaire development through stakeholder consultations3. Construct validation of questionnaires through cognitive testing4. Further assessment of construct validity by a nationwide pilot surveySetting:Patients with SCD and their carers were eligible. Focus group discussions took place innon-hospital settings, arranged out-of-hours. Cognitive testing took place in specialistSickle Cell clinics. The pilot survey was available to UK participants only and wasadministered through web-based questionnaires, face-to face completion and in sicklecell community events.Participants:Thirty-three patients and carers took part in the focus groups, 21 participants undertookcognitive testing and 722 respondents completed the pilot survey.Results:Findings highlighted a widespread prevalence of poor knowledge about SCD amonghealthcare providers and the public. Poorer experience of care was present in the emergency setting compared to planned care, of which lack of timely provision of painrelief was of concern. Adolescents and young people reported significantly poorerexperience of care in several domains compared to children or adults.Conclusions:The new surveys functioned well, with good evidence of validity, and were accessible tothe SCD patient population, supporting their future use in assessing patient experienceto inform service delivery and improvements in care quality.
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