[RECURRENT AND VIRTUAL EDUCATION FOR ALL DISCIPLINES AND OCCUPATIONS IN THE ALLERGY REALM : A SURVEY OF THE PARTICIPANTS FROM THE INITIATIVE 'OUTREACH LECTURES' TO CREATE EDUCATIONAL OPPORTUNITIES].

BACKGROUND: In the enhancement of allergy care involving multidisciplinary and multiple medical departments, there is a perceived need for education that targets not only specialists but also non-specialists. However, research on the need for and methods of such education remains inadequate. OBJECTIVE: To design a remote allergy care education program for all medical practitioners and to validate its necessity and utility. METHODS: The Empowering Next Generation Allergist/immunologist toward Global Excellence Task Force (ENGAGE-TF), supported by the Japanese Society of Allergology, initiated a virtual educational program called 'Outreach Lectures' in collaboration with Keio University and Fukui University. This initiative was widely promoted through social media and various institutions, and a survey was conducted through its mailing list. RESULTS: 1139 responses were obtained. More than half were physicians from non-allergy specialties, representing a diverse range of healthcare professions. Over 70% expressed being 'very satisfied,' and over 60% found the difficulty level 'appropriate.' Free-form feedback revealed differences in learning focus based on profession and learning approach based on years of experience. CONCLUSION: The high participation rate (90%) of non-specialist physicians underscores the demand for addressing allergic conditions in primary care. The effectiveness of virtual / recurrent education, particularly for healthcare professionals with over 11 years of experience, was implied. Further follow-up investigation focusing on quantitative and objective assessment of educational effectiveness is indispensable.

[STATE-OF-THE-ART OF GLOBAL START-UP INVESTMENT FOR ALLERGY AND IMMUNOLOGY 2022].

BACKGROUND: In 2022, the "New Capitalism Grand Design and Implementation Plan" was adopted in Japan, emphasizing the promotion and environmental development of startups. Given this context, an investigation into the startup and investment landscape in the allergy sector, both domestically and internationally, becomes imperative. METHODS: We analyzed 156 allergy-related startups from Japan, the US, and Europe from 2010 to 2021. Data on corporate information and investment trends were extracted from databases and VC websites. RESULTS: The total investment reached approximately 7.2 billion USD, with a ratio of 20:6:1 for the US, Europe, and Japan, respectively. The US showed a decline post its peak from 2016-2018, while Europe and Japan experienced growth. Notably, the US primarily invested in biopharmaceuticals for atopic dermatitis and food allergies, Europe in asthma-related apps, and Japan in healthcare apps and cross-border startups. DISCUSSION AND CONCLUSION: While Japan's investment environment in the allergy sector remains in its nascent stages and has room for development, the US and Europe are evidently ahead. Considering the rise of startups and funding limitations in Japan, external funding from regions like the US becomes a potential avenue. These findings are anticipated to contribute to the strategic activation of startups in allergy research and development.

Clinical risk factors at 3 months of age for the development of bronchial asthma at 36 months of age.

BACKGROUND: We examined the associations between factors evident at the routine 3-month well-child visit (WCV) and the risk of developing 36-month parent-reported physician-diagnosed bronchial asthma (BA). METHODS: This longitudinal study was conducted in Nagoya City, Japan, and included 40,242 children who qualified for the 3-month WCVs in the city between April 1, 2016 and March 31, 2018. In total, 22,052 (54.8%) questionnaires linked to their 36-month WCVs were analyzed. RESULTS: The prevalence of BA was 4.5%. The multivariable Poisson regression model identified male sex (adjusted risk ratio [aRR], 1.59; 95% confidence interval [CI]: 1.40-1.81), born in autumn (aRR, 1.30; 95% CI: 1.09-1.55), having at least one sibling (aRR, 1.31; 95% CI: 1.15-1.49), wheeze history before 3-month WCVs, with clinic/hospital visit: aRR, 1.99; 95% CI: 1.53-2.56; hospitalization: aRR, 2.99; 95% CI: 2.09-4.12, eczema with itch (aRR, 1.51; 95% CI: 1.27-1.80), paternal history of BA (aRR, 1.98; 95% CI: 1.66-2.34), maternal history of BA (aRR, 2.11; 95% CI: 1.77-2.49), and rearing pets with fur (aRR, 1.35; 95% CI: 1.15-1.58) were independent risk factors for BA at 36 months of age. The combination of severe wheeze history (with clinic/hospital visit or hospitalization) and maternal and paternal BA could identify high-risk infants whose prevalence of BA was 20%. CONCLUSIONS: The combined assessment of important clinical factors enabled us to identify high-risk infants set to derive optimal benefit from health guidance provided to the parent or caregiver of the child or infant at WCVs.

[JAPANESE TRANSLATION AND LINGUISTIC VALIDATION OF THE RECAP OF ATOPIC ECZEMA (RECAP)].

BACKGROUND: The Recap of atopic eczema (RECAP), a new core outcome of the atopic dermatitis trial, was translated into Japanese and linguistically validated. METHODS: Translation into Japanese was accomplished according to the ISPOR (International Society for Pharmacoeconomics and Outcome Research) guidelines and the basic guidelines for scale translation. The translation process included two forward translations, reconciliation with native English speakers, third-party back translation, cognitive debriefing, review and harmonization by the original authors. Twenty-seven atopic dermatitis and pediatric specialists from 21 centers in Japan participated in the translation process. Cognitive debriefing was conducted through face-to-face interviews using a think-aloud method with the interview guide including questions about comprehensibility, relevance, comprehensiveness, recall period and suggested improvements, based on the COSMIN methodology. RESULTS: No linguistic or cultural problems were encountered in the translation into Japanese. Cognitive debriefings were conducted with 10 adult patients and 10 parents of pediatric patients. Some minor modifications were made following discussion and approval by the research team and the original authors. The Japanese version of RECAP was considered to be understandable, comprehensive and relevant for adult patients and families of pediatric patients. CONCLUSION: The Japanese version of the RECAP, which has been validated as linguistically equivalent to the original version, is now available. Further evaluation of the measurement properties is needed in the future.

Executive summary: Japanese pediatric guideline for the treatment and management of asthma (JPGL) 2020.

This article covers the salient and updated themes of the Japanese Pediatric Guidelines for the Treatment and Management of Asthma (JPGL) 2020 published by the Japanese Society of Pediatric Allergy and Clinical Immunology. In the 2020 guidelines, five new clinical questions (CQs) have been added to address the 12 CQs regarding the treatment of childhood asthma. "Infant and preschool asthma" is diagnosed when young children (<6 years of age) have three or more episodes of clear expiratory wheezing, which continue for more than 24 h, and symptom improvement can be observed after beta-2 agonist inhalation. In children without clear improvement, diagnostic therapeutic trial for the duration of 1 month with controller treatment can be used. Since long-term management is initiated, the treatment level is adjusted based on the current control status and the management of risk factors, with the provision for holistic care. This underscores the smooth transition of pediatric patients into adult services. There are several differences between the JPGL and the guidelines of other countries. Further evidence is obtained as the utility of the newly proposed management plans should be evaluated in the Japanese population.

Is oral food challenge test useful for avoiding complete elimination of cow's milk in Japanese patients with or suspected of having IgE-dependent cow's milk allergy?

BACKGROUND: Cow's milk, along with hen's egg, are common causes of food allergies in children worldwide. Accidental ingestion of milk is common and often induces severe allergic reactions. Oral food challenge test (OFC) is usually performed in patients with or suspected of having a food allergy. However, the evidence of whether cow's milk OFC is useful in IgE-dependent cow's milk allergy patients to avoid total elimination is not known. METHODS: After setting the clinical question and outcomes, we performed a systematic review for relevant articles published from January 1, 2000 to August 31, 2019 using PubMed® and Ichushi-Web databases. Each article was then evaluated for the level of evidence. All positive results of the OFC were defined as adverse events. RESULTS: Forty articles were selected in this study. Our review revealed that cow's milk OFC was able to avoid the complete elimination of cow's milk in 66% of the patients with cow's milk allergy. We also found that adverse events occurred frequently (50.5%). CONCLUSIONS: This analysis supports the recommendation of conducting cow's milk OFC to avoid complete elimination of cow's milk, however the test should be conducted with careful consideration of the patient's safety. As the methods of OFC and subjects varied among the articles selected in this study, further studies are needed to obtain higher quality evidence.

Is oral food challenge useful to avoid complete elimination in Japanese patients diagnosed with or suspected of having IgE-dependent hen's egg allergy? A systematic review.

BACKGROUND: IgE-mediated egg allergy is a common food allergy worldwide. Patients with egg allergy are known to easily achieve tolerance compared to other allergens such as nuts. Oral food challenge (OFC) is often performed on patients diagnosed with or suspected of having IgE-mediated food allergy, but whether hen's egg OFC is useful in IgE-dependent egg allergy patients to avoid complete elimination remains unknown. METHODS: We identified articles in which OFCs were performed in Japanese patients diagnosed with or suspected of having IgE-mediated egg allergy. We evaluated whether the OFCs were useful to avoid the complete elimination of eggs by assessing the following: (1) the number of patients who could avoid complete elimination; (2) the number of patients who experienced serious adverse events (SAEs); or (3) adverse events (AEs); (4) improvement in quality of life (QOL); and (5) immunological changes. RESULTS: Fifty-nine articles were selected in the study; all the references were case series or case studies in which OFC was compared to pre-challenge conditions. The overall negative ratio against egg OFC was 62.7%, but an additional 71.9% of OFC-positive patients could take eggs when expanded to partial elimination. Of the 4182 cases, 1146 showed AEs in the OFC, and two cases reached an SAE. Two reports showed an improvement in QOL and immunological changes, although the evidence was weak. CONCLUSIONS: OFCs against eggs may be useful to avoid complete elimination, but medical professionals should proceed with the test safely and carefully.

Evaluation of adrenaline auto-injector prescription profiles: A population-based, retrospective cohort study within the National Insurance Claims Database of Japan.

BACKGROUND: Adrenaline is the first-line medication for managing anaphylaxis. A better understanding of prescription trends for adrenaline auto-injectors (AAIs) is important to improving patient care as well as information on health education interventions and medical guidelines. However, it has been difficult to gather comprehensive data in a sustainable manner. Thus, we aimed to investigate trends in AAI prescriptions in Japan. METHODS: We searched the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB), a unique and comprehensive database of health insurance claims, and investigated prescriptions for AAIs for all ages (April 2017 to March 2018). We assessed the annual number of prescriptions per person as well as prescription rates per 100,000 population per year by age, sex, and geographic region. RESULTS: A total of 88,039 subjects (56,109 males, 31,930 female) and 116,758 devices (1.33 AAIs per patient per year) were prescribed AAIs at least once a year for all ages. The prescription rate for AAIs was 69.5 per 100,000 population-years. Patients aged 0-9 years were prescribed AAIs at the rate of 278.9 per 100,000 population-years. Patients aged 0-19 years were 6.4 times more likely to be prescribed AAIs than those over 20 years of age. Males were more frequently prescribed AAIs than females in all age groups, except for those aged 20-24 years. We also evaluated differences in prescription rates by geographic region. CONCLUSIONS: This comprehensive evaluation revealed trends in AAI prescriptions, thus helping develop preventive strategies with respect to anaphylaxis in Japan.

Executive summary: Japanese guidelines for atopic dermatitis (ADGL) 2021.

This is an abridged edition of English version of the Clinical Practice Guidelines for the Management of Atopic Dermatitis 2021. Atopic dermatitis (AD) is a disease characterized by relapsing eczema with pruritus as a primary lesion. In Japan, from the perspective of evidence-based medicine, the current strategies for the treatment of AD consist of three primary measures: (i) use of topical corticosteroids, tacrolimus ointment, and delgocitinib ointment as the main treatment of the inflammation; (ii) topical application of emollients to treat the cutaneous barrier dysfunction; and (iii) avoidance of apparent exacerbating factors, psychological counseling, and advice about daily life. In the present revised guidelines, the description about three new drugs, namely, dupilumab, delgocitinib, and baricitinib, has been added. The guidelines present recommendations to review clinical research articles, evaluate the balance between the advantages and disadvantages of medical activities, and optimize medical activity-related patient outcomes with respect to several important points requiring decision-making in clinical practice.

Do allergic clinical manifestations increase the risk of behavioral problems in children? A cross-sectional study.

BACKGROUND: Children with allergic clinical manifestations tend to have behavioral or emotional problems such as hyperactivity or worse mental health. However, previous studies on this association did not adequately adjust for confounders like parenting stress, demographic characteristics, or allergy presentation. This study aimed to investigate the relationship between childhood allergic clinical manifestations and behavioral problems, adjusting for confounders such as demographic characteristics, parenting stress, and allergy-related variables. METHODS: We conducted an online cross-sectional survey among caregivers of children aged 2-6 years (n = 633). The Strengths and Difficulties Questionnaire (SDQ) was used to determine children's behavioral characteristics as the primary outcome. Allergic clinical manifestations, wheeze, rash, and nose symptoms were the exposure variables. Associations were estimated using logistic regression analyses with propensity scores to adjust for confounders. RESULTS: We analyzed 633 caregivers of children aged 2-6 years (valid rate, 61.5%). Univariate analyses showed that wheezing was associated with conduct problems (odds ratio [OR] = 1.48, 95% confidence interval [CI]:1.01-2.16), a behavioral component of the SDQ. Rash was also associated with hyperactivity (OR = 1.62, 95% CI: 1.02-2.57). Furthermore, nose symptoms were associated with conduct problems (OR = 1.65, 95% CI:1.16-2.33) and emotional symptoms (OR=1.62, 95% CI:1.06-2.45). After adjusting for potential confounders, wheezing (adjusted OR = 1.69, 95% CI:1.04-2.75) and nose symptoms (adjusted OR = 1.56, 95% CI: 1.05-2.34) remained associated with conduct problems. CONCLUSIONS: This study revealed that a history of wheezing and nose symptoms in children is associated with an increased risk of behavioral problems, in particular, conduct problems.

Prevalence and associated factors of wheeze in early infancy.

BACKGROUND: The aim of this study was to assess the prevalence of wheeze in early childhood and to characterize associated factors for wheeze that could identify potentially feasible interventions for the future prevention of wheeze. METHODS: We performed a cross-sectional analysis of the data from the International Study of Asthma and Allergies in Childhood (ISAAC)-modified self-administered questionnaire of parents of 4-month-old infants at well-child visits (mandatory health check-ups) in Nagoya City, Japan, between April 2016 and March 2017 (development dataset) and between April 2017 and March 2018 (validation dataset). We used a multivariable, multilevel analysis to identify significant (P < 0.05), associated factors (Bonferroni correction was applied as necessary) after adjustment for local outbreaks of virus-transmitted diseases, access to medical facilities, and socioeconomic status. RESULTS: Among the 20 362 questionnaires given to families of infants living in Nagoya City (development dataset), 19 104 questionnaires (93.8%) were analyzed after data cleaning. In all, 1,446 (7.6%) infants experienced wheeze at least once within 4 months of age, 991 (5.2%) visited the clinic/hospital with wheeze, and 244 (1.3%) underwent hospitalization at that time. In the multilevel, multivariable model for hospitalization with wheeze, significant associated factors were male sex (adjusted odds ratio 1.8; 95% confidence interval 1.4-2.3), maternal current smoking (3.3; 2.0-5.5), and having at least one sibling (3.0; 2.2-4.1). These factors were also associated with wheeze and clinic/hospital visit with wheeze, and the results were confirmed in the validation dataset. CONCLUSIONS: Our study highlights that smoking cessation among mothers and improved hand hygiene at home are two interventions that could potentially decrease wheeze in early infancy.

Japanese guidelines for atopic dermatitis 2020.

Atopic dermatitis (AD) is a disease characterized by relapsing eczema with pruritus as a primary lesion, which is frequently encountered in clinical practice. Skin barrier dysfunction leads to enhanced skin irritability to non-specific stimuli and epicutaneous sensitization. In the lesion site, a further inflammation-related reduction in skin barrier function, enhanced irritability and scratching-related stimuli deteriorate eczema, leading to vicious cycle of inflammation. The current strategies to treat AD in Japan from the perspective of evidence-based medicine consist of three primary measures: (i) the use of topical corticosteroids and tacrolimus ointment as the main treatment for the inflammation; (ii) topical application of emollients to treat the cutaneous barrier dysfunction; and (iii) avoidance of apparent exacerbating factors, psychological counseling and advice about daily life. The guidelines present recommendations to review clinical research articles, evaluate the balance between the advantages and disadvantages of medical activities, and optimize medical activity-related patient outcomes with respect to several important points requiring decision-making in clinical practice.

Topical corticosteroid phobia among caretakers of children with atopic dermatitis: A cross-sectional study using TOPICOP in Japan.

BACKGROUND/OBJECTIVES: The TOPICOP scale is an easy-to-use scale for assessing topical corticosteroid (TCS) phobia in atopic dermatitis (AD) patients and their caretakers. TCS phobia is a common problem among AD patients and their caretakers. The aim of this study was to examine the relationship between TCS phobia in caretakers of children with AD and the characteristics of patients using the TOPICOP scale. METHODS: Caretakers of AD patients who visited the allergy clinic at the National Center for Child Health and Development in Tokyo between February 2014 and May 2014 were recruited. Caretakers of patients in follow-up had already attended an education session on treatment at the institution. All participants completed an anonymous questionnaire on the characteristics of the respondents and patients using the Patient-Oriented Eczema Measure (POEM) and the Japanese version of TOPICOP. RESULTS: In total, 243 participants (88.9% female) completed the survey. The average TOPICOP score was 40.3 and the median POEM score was 4. The TOPICOP score was significantly higher for patients younger than 12 months old with moderate to very severe AD (POEM ≥ 8) whose caretaker had not attended an educational session (P < 0.01, respectively). There was no significant difference in the family history of AD, age, or gender of the respondents. In multivariable analysis, preattendance at an education session was the only significant factor accounting for a higher TOPICOP score (P < 0.001). CONCLUSIONS: Regardless of their background, caretakers of AD patients can be affected from TCS phobia. Attending an educational session might ease their anxiety.

Factors determining parenting stress in mothers of children with atopic dermatitis.

BACKGROUND: Atopic dermatitis (AD) influences a child's emotional and social well-being, as well as his or her physical health. The influence of AD on the daily lives of parents and caregivers has also been documented. This study examined how parenting stress is affected by demographic background, characteristics of children's AD, and their family systems. METHODS: The participants were mothers of children, aged 2-6 years old, who had been diagnosed with AD. The predictive power of a model of parenting stress was examined using multiple regression analysis (stepwise), with parenting stress (PSI-SF) as the dependent variable, and children's demographics, including characteristics of AD; parents' demographics; QoL of families of children with AD (JCMV-CADIS); and family functioning (FAI) as independent variables. We handled missing values using a multiple imputation method. RESULTS: The pooled coefficients obtained from the multiple regression analysis after multiple imputation indicated that "family cohesion," "family system flexibility," "emotions related to social factors" and "occupation of mother" determined parenting stress. Lower family cohesion and family system flexibility predicted higher parenting stress. The high impact of "emotions related to social factors" on families' QoL predicted higher parenting stress. Full-time work by mothers predicted lower parenting stress. CONCLUSIONS: The current results reveal that "family cohesion," "family system flexibility," "emotions related to social factors" and "full-time work by mothers" predicted parenting stress of mothers who had children with AD.

Leukotriene receptor antagonists for eczema.

BACKGROUND: Eczema is a common, chronic, inflammatory skin condition that is frequently associated with atopic conditions, including asthma. Leukotriene receptor antagonists (LTRAs) have a corticosteroid-sparing role in asthma, but their role in eczema remains controversial. Currently available topical therapies for eczema are often poorly tolerated, and use of systemic agents is restricted by their adverse effect profile. A review of alternative treatments was therefore warranted. OBJECTIVES: To assess the possible benefits and harms of leukotriene receptor antagonists for eczema. SEARCH METHODS: We searched the following databases to September 2017: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and the GREAT database. We also searched five trial registries, and handsearched the bibliographies of all extracted studies for further relevant trials. SELECTION CRITERIA: Randomised controlled trials of LTRAs alone or in combination with other (topical or systemic) treatments compared with other treatments alone such as topical corticosteroids or placebo for eczema in the acute or chronic (maintenance) phase of eczema in adults and children. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. The primary outcome measures were change in disease severity, long-term symptom control, and adverse effects of treatment. Secondary outcomes were change in corticosteroid requirement, reduction of pruritis, quality of life, and emollient requirement. We used GRADE to assess the quality of the evidence for each outcome. MAIN RESULTS: Only five studies (including a total of 202 participants) met the inclusion criteria, all of which assessed oral montelukast; hence, we found no studies assessing other LTRAs. Treatment ranged from four to eight weeks, and outcomes were assessed at the end of treatment; therefore, we could only report short-term measurements (defined as less than three months follow-up from baseline). Montelukast dosing was 10 mg for adults (age 14 years and above) and 5 mg for children (age 6 years to 14 years). One study included children (aged 6 years and above) among their participants, while the remaining studies only included adults (participant age ranged from 16 to 70 years). The participants were diagnosed with moderate-to-severe eczema in four studies and moderate eczema in one study. The study setting was unclear in two studies, multicentre in two studies, and single centre in one study; the studies were conducted in Europe and Bangladesh. Two studies were industry funded. The comparator was placebo in three studies and conventional treatment in two studies. The conventional treatment comparator was a combination of antihistamines and topical corticosteroids (plus oral antibiotics in one study).Four of the studies did not adequately describe their randomisation or allocation concealment method and were considered as at unclear risk of selection bias. Only one study was at low risk of performance and detection bias. However, we judged all studies to be at low risk of attrition and reporting bias.We found no evidence of a difference in disease severity of moderate-to-severe eczema after short-term use of montelukast (10 mg) when compared with placebo. The outcome was assessed using the modified EASI (Eczema Area and Severity Index) score and SASSAD (Six Area, Six Sign Atopic Dermatitis) severity score (standardised mean difference 0.29, with a positive score showing montelukast is favoured, 95% confidence interval (CI) -0.23 to 0.81; 3 studies; n = 131; low-quality evidence).When short-term montelukast (10 mg) treatment was compared with conventional treatment in one study, the mean improvement in severity of moderate-to-severe eczema was greater in the intervention group (measured using SCORAD (SCORing of Atopic Dermatitis) severity index) (mean difference 10.57, 95% CI 4.58 to 16.56; n = 31); however, another study of 32 participants found no significant difference between groups using the same measure (mean improvement was 25.2 points with montelukast versus 23.9 points with conventional treatment; no further numerical data provided). We judged the quality of the evidence as very low for this outcome, meaning the results are uncertain.All studies reported their adverse event rate during treatment. Four studies (136 participants) reported no adverse events. In one study of 58 participants with moderate eczema who received montelukast 10 mg (compared with placebo), there was one case of septicaemia and one case of dizziness reported in the intervention group, both resulting in study withdrawal, although whether these effects were related to the medication is unclear. Mild side effects (e.g. headache and mild gastrointestinal disturbances) were also noted, but these were fairly evenly distributed between the montelukast and placebo groups. The quality of evidence for this outcome was low.No studies specifically evaluated emollient requirement or quality of life. One study that administered treatment for eight weeks specifically evaluated pruritus improvement at the end treatment and topical corticosteroid use during treatment. We found no evidence of a difference between montelukast (10 mg) and placebo for both outcomes (low-quality evidence, n = 58). No other study assessed these outcomes. AUTHORS' CONCLUSIONS: The findings of this review are limited to montelukast. There was a lack of evidence addressing the review question, and the quality of the available evidence for most of the measured outcomes was low. Some primary and secondary outcomes were not addressed at all, including long-term control.We found no evidence of a difference between montelukast (10 mg) and placebo on disease severity, pruritus improvement, and topical corticosteroid use. Very low-quality evidence means we are uncertain of the effect of montelukast (10 mg) compared with conventional treatment on disease severity. Participants in only one study reported adverse events, which were mainly mild (low-quality evidence).There is no evidence that LTRA is an effective treatment for eczema. Serious limitations were that all studies focused on montelukast and only included people with moderate-to-severe eczema, who were mainly adults; and that each outcome was evaluated with a small sample size, if at all.Further large randomised controlled trials, with a longer treatment duration, of adults and children who have eczema of all severities may help to evaluate the effect of all types of LTRA, especially on eczema maintenance.

A systematic review of Investigator Global Assessment (IGA) in atopic dermatitis (AD) trials: Many options, no standards.

BACKGROUND: Investigators often use global assessments to provide a snapshot of overall disease severity in dermatologic clinical trials. Although easy to perform, the frequency of use and standardization of global assessments in studies of atopic dermatitis (AD) is unclear. OBJECTIVES: We sought to assess the frequency, definitions, and methods of analysis of Investigator Global Assessment in randomized controlled trials of AD. METHODS: We conducted a systematic review using all published randomized controlled trials of AD treatments in the Global Resource of Eczema Trials database (2000-2014). We determined the frequency of global scales application and defining features. RESULTS: Among 317 trials identified, 101 trials (32%) used an investigator-performed global assessment as an outcome measure. There was large variability in global assessments between studies in nomenclature, scale size, definitions, outcome description, and analysis. Both static and dynamic scales were identified that ranged from 4- to 7-point scales. North American studies used global assessments more commonly than studies from other countries. LIMITATIONS: The search was restricted to the Global Resource of Eczema Trials database. CONCLUSION: Global assessments are used frequently in studies of AD, but their complete lack of standardized definitions and implementation preclude any meaningful comparisons between studies, which in turn impedes data synthesis to inform clinical decision-making. Standardization is urgently required.