RESUMO
Use of medical devices (MDs), that is, glucose sensors and insulin pumps, in patients with Type 1 diabetes mellitus (T1D) has proven an enormous advantage for disease control. Adverse skin reactions from these MDs may however hamper compliance. The objective of this study was to systematically review and analyse studies assessing the prevalence and incidence of dermatitis, including allergic contact dermatitis (ACD) related to MDs used in patients with T1D and to compare referral routes and the clinical investigation routines between clinics being part of the European Environmental and Contact Dermatitis Research Group (EECDRG). A systematic search of PubMed, EMBASE, CINAHL and Cochrane databases of full-text studies reporting incidence and prevalence of dermatitis in persons with T1D using MDs was conducted until December 2021. The Newcastle-Ottawa Scale was used to assess study quality. The inventory performed at EECRDG clinics focused on referral routes, patient numbers and the diagnostic process. Among the 3145 screened abstracts, 39 studies fulfilled the inclusion criteria. Sixteen studies included data on children only, 14 studies were on adults and nine studies reported data on both children and adults. Participants were exposed to a broad range of devices. Skin reactions were rarely specified. It was found that both the diagnostic process and referral routes differ in different centres. Further data on the prevalence of skin reactions related to MDs in individuals with T1D is needed and particularly studies where the skin reactions are correctly diagnosed. A correct diagnosis is delayed or hampered by the fact that, at present, the actual substances within the MDs are not declared, are changed without notice and the commercially available test materials are not adequately updated. Within Europe, routines for referral should be made more standardized to improve the diagnostic procedure when investigating patients with possible ACD from MDs.
Assuntos
Dermatite Alérgica de Contato , Diabetes Mellitus Tipo 1 , Humanos , Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 1/epidemiologia , Prevalência , Dermatite Alérgica de Contato/epidemiologia , Dermatite Alérgica de Contato/etiologia , Dermatite Alérgica de Contato/diagnóstico , Criança , Adulto , Automonitorização da Glicemia/instrumentação , Sistemas de Infusão de Insulina/efeitos adversos , Inquéritos e Questionários , IncidênciaRESUMO
Atopic dermatitis (AD) is a chronic, auto-immune condition that imposes a high burden on individuals, society, and the healthcare system. Approximately 4.4% of adults and up to 18.6% of children/adolescents have AD in Europe, with 20% of all cases accounting for moderate-to-severe forms. This form of the condition in adults results in annual societal costs across Europe of an estimated 30 billion; 15.2 billion related to missed workdays or reduced work productivity, 10.1 billion related to direct medical costs and 4.7 billion related to personal expenditure of patients/families. AD can also substantially impact physical, emotional, and social quality-of-life. Several studies have shown the debilitating itch-scratch cycle is the main cause of the multifaceted burden, as it causes substantial sleep deprivation and stigmatisation due to the physical appearance of the skin, and confidence issues. These factors lead to psychosocial issues and can cumulate over time and prohibit patients reaching their 'full life potential'. Despite this, many patients with the condition are undertreated, resulting in uncontrolled symptoms and a further strain placed on patients, society, and the economy. The authors of this White Paper comprise the European Atopic Dermatitis Working Group, which is a network of international specialists with expertise in dermatology and healthcare policy decisions. Their programme of action is focused on harnessing their expertise to build consensus, advance research, share knowledge, and ultimately seek to improve AD care outcomes through achieving long-term symptom control. This White Paper presents a systematic evaluation of the overall financial and humanistic burden of moderate-to-severe AD and the current challenges that exist with AD care. It introduces recommendations for how, collaboratively, key stakeholders and policy makers can support improvements in AD management to achieve better disease control, thus reducing the costs and associated burden placed on individuals, society, and the economy.
Assuntos
Dermatite Atópica , Adolescente , Adulto , Criança , Efeitos Psicossociais da Doença , Dermatite Atópica/diagnóstico , Europa (Continente) , Custos de Cuidados de Saúde , Humanos , Prurido , Qualidade de Vida , Índice de Gravidade de DoençaRESUMO
BACKGROUND: Atopic dermatitis (AD) is a complex disease with variations in severity and healthcare utilization. Examining patient pathways through analyses of longitudinal patient data provides an opportunity to describe real-world clinical patient care and evaluate healthcare access and treatment. OBJECTIVE: To describe longitudinal care pathways including health care management, treatment patterns and disease progression (by proxy measures) in patients with AD. MATERIALS AND METHODS: This was a longitudinal observational study, which used linked data from national and regional healthcare registers in Sweden. Patients with AD were identified through diagnosis in primary or secondary care or by dispensed medications. Descriptive statistics for number of healthcare visits, type of dispensed drug class, rate of - and time to - referral to secondary care and treatment escalation were calculated. RESULTS: A total of 341 866 patients with AD distributed as 197 959 paediatric (age < 12), 36 133 adolescent (age ≥ 12- < 18) and 107 774 adult (age ≥ 18) patients were included in this study. Healthcare visits to primary and secondary care and dispensation of AD-indicated treatments were more common during the year in which managed AD care was initiated. Topical corticosteroids (TCSs) and emollients were the most frequently used treatments across all age cohorts while systemic treatment was uncommon in all age cohorts. Among patients who initiated treatment with TCSs, 18.2% escalated to TCSs with higher potency following the start of managed AD care. CONCLUSIONS: We found that healthcare contacts and use of AD-indicated treatments were concentrated in the year during which managed AD care was initiated and decreased significantly thereafter. Since a significant proportion of patients with AD have flares and persistent AD, our results suggest that patients with AD may be monitored infrequently and are undertreated. There is a need to inform practitioners about adequate treatment options to provide individualized care, in particular for patients with persistent severe AD.
Assuntos
Dermatite Atópica , Fármacos Dermatológicos , Adolescente , Adulto , Criança , Estudos de Coortes , Procedimentos Clínicos , Dermatite Atópica/tratamento farmacológico , Fármacos Dermatológicos/uso terapêutico , Emolientes/uso terapêutico , Glucocorticoides/uso terapêutico , Humanos , Estudos RetrospectivosAssuntos
Anafilaxia , COVID-19 , Dermatite Atópica , Vacinas , Vacinas contra COVID-19 , Dermatite Atópica/prevenção & controle , Humanos , SARS-CoV-2Assuntos
Produtos Biológicos , COVID-19 , Dermatite Atópica , Adulto , Dermatite Atópica/tratamento farmacológico , Humanos , SARS-CoV-2 , VacinaçãoRESUMO
Atopic dermatitis (AD) is a disease that can have a high impact on quality of life, especially due to itch and skin pain. This paper utilizes expertise from members of the International Society of Atopic Dermatitis (ISAD)/Oriented Patient-Education Network in Dermatology (OPENED) task force to review the epidemiology, pathophysiology and exacerbating factors of itch and pain in atopic dermatitis. General principles of treatment are provided, as well as a more detailed evaluation of topical and systemic therapies. Educational and psychological approaches to itch and pain in atopic dermatitis are proposed, along with expert recommendations for the management of itch and pain in atopic dermatitis.
Assuntos
Dermatite Atópica , Dermatologia , Dermatite Atópica/complicações , Dermatite Atópica/terapia , Humanos , Dor , Prurido/etiologia , Prurido/terapia , Qualidade de VidaRESUMO
Atopic dermatitis (AD) is a highly pruritic, chronic inflammatory skin disease. The diagnosis is made using evaluated clinical criteria. Disease activity and burden are best measured with a composite score, assessing both objective and subjective symptoms, such as SCORing Atopic Dermatitis (SCORAD). AD management must take into account clinical and pathogenic variabilities, the patient's age and also target flare prevention. Basic therapy includes hydrating and barrier-stabilizing topical treatment universally applied, as well as avoiding specific and unspecific provocation factors. Visible skin lesions are treated with anti-inflammatory topical agents such as corticosteroids and calcineurin inhibitors (tacrolimus and pimecrolimus), which are preferred in sensitive locations. Topical tacrolimus and some mid-potency corticosteroids are proven agents for proactive therapy, which is defined as the long-term intermittent anti-inflammatory therapy of frequently relapsing skin areas. Systemic anti-inflammatory or immunosuppressive treatment is a rapidly changing field requiring monitoring. Oral corticosteroids have a largely unfavourable benefit-risk ratio. The IL-4R-blocker dupilumab is a safe, effective and licensed, but expensive, treatment option with potential ocular side-effects. Other biologicals targeting key pathways in the atopic immune response, as well as different Janus kinase inhibitors, are among emerging treatment options. Dysbalanced microbial colonization and infection may induce disease exacerbation and can justify additional antimicrobial treatment. Systemic antihistamines (H1R-blockers) only have limited effects on AD-related itch and eczema lesions. Adjuvant therapy includes UV irradiation, preferably narrowband UVB or UVA1. Coal tar may be useful for atopic hand and foot eczema. Dietary recommendations should be patient-specific, and elimination diets should only be advised in case of proven food allergy. Allergen-specific immunotherapy to aeroallergens may be useful in selected cases. Psychosomatic counselling is recommended to address stress-induced exacerbations. Efficacy-proven 'Eczema school' educational programmes and therapeutic patient education are recommended for both children and adults.
Assuntos
Dermatite Atópica , Eczema , Adulto , Anti-Inflamatórios/uso terapêutico , Inibidores de Calcineurina/uso terapêutico , Criança , Dermatite Atópica/diagnóstico , Dermatite Atópica/tratamento farmacológico , Humanos , Prurido , Tacrolimo/uso terapêuticoAssuntos
Dermatite Atópica , Psoríase , Luto , Estudos de Coortes , Dinamarca , Dermatite Atópica/epidemiologia , Humanos , Incidência , Psoríase/epidemiologiaAssuntos
Infecções por Coronavirus/epidemiologia , Dermatite Atópica/epidemiologia , Imunossupressores/uso terapêutico , Pneumonia Viral/epidemiologia , Guias de Prática Clínica como Assunto , Síndrome Respiratória Aguda Grave/epidemiologia , Comitês Consultivos , COVID-19 , Comorbidade , Infecções por Coronavirus/imunologia , Dermatite Atópica/tratamento farmacológico , Dermatite Atópica/imunologia , Europa (Continente) , Feminino , Humanos , Hospedeiro Imunocomprometido/efeitos dos fármacos , Masculino , Pandemias , Pneumonia Viral/imunologia , Medição de Risco , Síndrome Respiratória Aguda Grave/imunologia , Resultado do TratamentoRESUMO
BACKGROUND: A long-term prospective observational safety study is essential to characterize fully the safety profile of systemic immunomodulating therapies for patients with atopic eczema. The TREatment of ATopic eczema (TREAT) Registry Taskforce offers a large platform to conduct such research using national registries that collect the same data using a predefined core dataset. OBJECTIVES: To present a protocol for a safety study comparing dupilumab with other systemic immunomodulating therapies in children and adults with moderate-to-severe atopic eczema, to assess the long-term safety risk of these therapies in a routine clinical care setting. METHODS: We describe a registry-embedded international observational prospective cohort study. Adult and paediatric patients who start treatment with dupilumab or another systemic immunomodulating agent for their atopic eczema will be included. The primary end point is the incidence of malignancies (excluding nonmelanoma skin cancer) compared between the treatment groups. Secondary end points include other serious adverse events and adverse events of special interest, such as eye disorders and eosinophilia. CONCLUSIONS: This protocol delineates a safety study for dupilumab in adult and paediatric patients with atopic eczema, using a standardized methodological approach across several national registries. The protocol could also be used for other novel systemic immunomodulating therapies, and could provide licensing and reimbursement authorities, pharmaceutical companies and clinicians with safety evidence from a routine clinical care setting. What's already known about this topic? There is a need for long-term data on the safety of systemic immunomodulating therapies in patients with atopic eczema. Regulatory bodies, such as the European Medicines Agency, increasingly stipulate the collection of such data as part of the licensing agreement for new treatments, to assess the new agent's long-term safety profile against established therapies. Large numbers of patients with a long duration of follow-up are necessary in order to detect rare events like malignancies. What does this study add? The TREAT Registry Taskforce offers a platform to conduct such research with a network of multiple national atopic eczema research registries. We present a protocol for an investigator-initiated multicentre safety study comparing dupilumab with other systemic immunomodulating therapies in adults and subsequently adolescents and children with moderate-to-severe atopic eczema. This protocol can be used as a framework for similar studies for other novel systemic immunomodulating therapies across both adult and paediatric populations.
Assuntos
Dermatite Atópica , Eczema , Adolescente , Adulto , Anticorpos Monoclonais Humanizados , Criança , Dermatite Atópica/tratamento farmacológico , Humanos , Estudos Observacionais como Assunto , Estudos Prospectivos , Sistema de Registros , Resultado do TratamentoRESUMO
BACKGROUND: Eczema control has been identified as an important outcome by key stakeholders in eczema research (including patients, carers, healthcare professionals and researchers) but no validated instruments for the domain have been identified. OBJECTIVES: To develop a measurement instrument to capture a patient's perspective of eczema control that is suitable for use in eczema clinical trials. METHODS: Best practice for the development of a patient-reported outcome was followed. A mixed-methods approach was used to develop and refine a conceptual framework, generate, refine and select items and to test the distribution and construct validity of the final scale. The mixed-methods approach involved expert panel meetings (including patient representatives, healthcare professionals and methodologists), and data collection using a focus group, cognitive interviews and an online survey with people with eczema and caregivers. Multivariable linear regression was used in the item selection process. RESULTS: Fourteen expert panel members co-produced the instrument, with input from people with eczema and caregivers via a focus group (n = 6), cognitive interviews (n = 13) and an online survey (n = 330). The resulting instrument, Recap of atopic eczema (RECAP), is a seven-item questionnaire that captures eczema control via self or caregiver report. The development process aimed to ensure good content validity and feasibility. Initial testing suggested no floor or ceiling effects and good construct validity. Hypothesized correlation with the Patient-Oriented Eczema Measure was confirmed [r(258) = 0·83, P < 0·001]. CONCLUSIONS: RECAP has the potential to improve reporting of eczema control in research and clinical practice. Further exploration of measurement properties is required. Linked Comment: Pattinson and Bundy. Br J Dermatol 2020; 183:418-419. What's already known about this topic? Eczema control has been identified as an important outcome by key stakeholders in eczema research (including patients, carers, healthcare professionals and researchers). Qualitative studies suggest eczema control is a multifaceted and individual experience and no instrument has been identified that captures eczema control in this way. What does this study add? We have developed Recap of atopic eczema (RECAP), a seven-item questionnaire to capture the experience of eczema control in all ages and eczema severities; there are two versions: a self-reported version for adults and older children with eczema, and a caregiver-reported version for younger children with eczema. Designed with input from people with eczema, caregivers and healthcare professionals to ensure good content validity. Initial testing of score distributions and construct validity suggests good measurement properties. What are the clinical implications of the work? The RECAP instrument is appropriate and feasible for measuring eczema control in clinical trials and may also be useful in routine practice.
Assuntos
Dermatite Atópica , Eczema , Adolescente , Adulto , Cuidadores , Criança , Dermatite Atópica/prevenção & controle , Eczema/prevenção & controle , Humanos , Medidas de Resultados Relatados pelo Paciente , Inquéritos e QuestionáriosRESUMO
Atopic dermatitis (AD) is a common inflammatory skin disease that affects both children and adults, including a large number of adults of reproductive age. Several guidelines for the treatment of AD exist, yet specific recommendations for the treatment of pregnant or lactating women and for adults planning to have a child are often lacking. This position paper from the European Task force on Atopic Dermatitis (ETFAD) is based on up-to-date scientific literature on treating pregnant and lactating women as wells as adults with AD planning to have a child. It is based on the expert opinions of members of the ETFAD and on existing safety data on the proposed treatments, many of which are derived from patients with other inflammatory diseases or from transplantation medicine. For treating future parents, as well as pregnant and lactating women with AD, the use of topical treatments including moisturizers, topical corticosteroids, tacrolimus, antiseptics such as chlorhexidine, octenidine, potassium permanganate and sodium hypochlorite (bleach) is deemed to be safe. Ultraviolet (UV) therapy may also be used. Systemic treatment should be prescribed only after careful consideration. According to the opinion of the ETFAD, treatment should be restricted to systemic corticosteroids and cyclosporine A, and, in selected cases, azathioprine.
Assuntos
Dermatite Atópica/terapia , Fármacos Dermatológicos/uso terapêutico , Lactação , Cuidado Pré-Concepcional , Terapia Ultravioleta , Adulto , Comitês Consultivos , Europa (Continente) , Feminino , Humanos , Masculino , GravidezRESUMO
BACKGROUND: Atopic eczema (also known as eczema) is a chronic, inflammatory skin condition that often afflicts patients' health and well-being. The Harmonising Outcome Measures for Eczema (HOME) initiative recommends that 'long-term control of eczema' is measured in all clinical trials 3 months or longer in duration. However, little has been published on what eczema control means to those living with or treating atopic eczema. OBJECTIVES: To (i) develop understanding of what eczema control means to patients, carers and clinicians and (ii) explore the feasibility and acceptability of different ways of measuring eczema control in the long term. METHODS: Online focus groups explored patients/carers experiences in the UK, the United States, the Netherlands, France, Sweden and Japan, and an international online survey gathered views of clinicians. The framework method was used to analyse the focus groups, and thematic analysis was used to analyse survey data. All findings were integrated into a theoretical framework to create overarching themes that cut across these diverse groups. RESULTS: Eight focus groups with patients (16 years+) and eight groups with carers of children took place (N = 97). Sixty-two people took part in the survey. Eczema control was described as a multifaceted construct involving changes in disease activity, the treatment and management of the condition and psychological, social and physical functioning. Patient/carer measurement allows personal accounts and frequent measurement, whilst clinician measurement was deemed less subjective. The burden on patients/carers and issues for analysing and interpreting data should be considered. CONCLUSIONS: This study formed the basis of judging the content validity and feasibility of measurement instruments/methods to assess control of eczema in clinical trials. This online approach to an international qualitative study is an example of how core outcome set developers with limited resources can engage with multiple stakeholder groups on an international basis to inform consensus meeting discussions.
Assuntos
Dermatite Atópica/prevenção & controle , Eczema/prevenção & controle , Adolescente , Adulto , Criança , Feminino , Grupos Focais , Humanos , Masculino , Pesquisa Qualitativa , Adulto JovemRESUMO
BACKGROUND: Atopic dermatitis (AD) might adversely affect academic performance, possibly through influences on psychological functioning such as stress resilience. OBJECTIVES: To investigate the association of atopic dermatitis with stress resilience, cognitive function and educational attainment. METHODS: We used data from a national cohort of men who underwent a military conscription examination at ages 17-20 years in Sweden between 1969 and 1976. All potential conscripts met a physician who assessed current or previous history of AD. Stress resilience was measured by a psychologist using a semistructured interview. The conscription assessment included a written cognitive function test. The highest level of education achieved was identified through record linkage. RESULTS: The study population included 234 715 men, 1673 (0·7%) of whom had a diagnosis of AD. AD was associated with a greater risk of low stress resilience [adjusted relative risk ratio (RRR) 1·60, 95% confidence interval (CI) 1·38-1·86]. AD was associated with higher cognitive function (ß-coefficient 0·15, 95% CI 0·05-0·24) and higher educational level (RRR 1·29, 95% CI 1·13-1·47). However, adjustment for socioeconomic characteristics of the family of origin attenuated the magnitude of the associations and eliminated the statistical significance (ß-coefficient 0·06, 95% CI -0·03 to 0·15; RRR 1·16, 95% CI 1·00-1·35). CONCLUSIONS: Swedish men with AD had lower stress resilience in late adolescence but did not have lower cognitive function or poorer educational attainment. The lower stress resilience associated with AD is consistent with an increased risk of possible long-term adverse health outcomes.
Assuntos
Sucesso Acadêmico , Cognição , Dermatite Atópica/psicologia , Resiliência Psicológica , Estresse Psicológico/psicologia , Adolescente , Dermatite Atópica/complicações , Dermatite Atópica/epidemiologia , Humanos , Masculino , Militares/estatística & dados numéricos , Prevalência , Estudos Prospectivos , Fatores de Risco , Fatores Socioeconômicos , Estresse Psicológico/etiologia , Suécia/epidemiologia , Adulto JovemRESUMO
BACKGROUND: Symptoms have been identified as a core outcome domain for atopic eczema (AE) trials. Various instruments exist to measure symptoms in AE, but they vary in quality and there is a lack of standardization between clinical trials. Our objective was to systematically evaluate the quality of the evidence on the measurement properties of AE symptom instruments, thereby informing consensus discussions within the Harmonising Outcome Measures for Eczema (HOME) initiative regarding the most appropriate instruments for the core outcome domain symptoms. METHODS: Using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist and predefined criteria for good measurement properties on identified development and validation studies of AE symptom instruments, a best evidence synthesis was performed to draw an overall conclusion on quality of the instruments and to provide recommendations. RESULTS: Eighteen instruments were identified and evaluated. When the quality and results of the studies were considered, only five of these instruments had sufficient validation data to consider them for the core outcome set for the core outcome domain symptoms. These were the paediatric Itch Severity Scale (ISS), Patient-Oriented Eczema Measure (POEM), Patient-Oriented SCOring Atopic Dermatitis (PO-SCORAD), Self-Administered Eczema Area and Severity Index (SA-EASI) and adapted SA-EASI. CONCLUSIONS: ISS (paediatric version), POEM, PO-SCORAD, SA-EASI and adapted SA-EASI are currently the most appropriate instruments and therefore have the potential to be recommended as core symptom instrument in future clinical trials. These findings will be utilized for the development of a core outcome set for AE.
Assuntos
Dermatite Atópica/diagnóstico , Eczema/diagnóstico , Humanos , Avaliação de Resultados em Cuidados de Saúde , Índice de Gravidade de Doença , Avaliação de SintomasRESUMO
BACKGROUND: The Harmonising Outcome Measures for Eczema (HOME) initiative has defined four core outcome domains for a core outcome set (COS) to be measured in all atopic eczema (AE) trials to ensure cross-trial comparison: clinical signs, symptoms, quality of life and long-term control. OBJECTIVES: The aim of this paper is to report on the consensus process that was used to select the core instrument to consistently assess symptoms in all future AE trials. METHODS: Following the HOME roadmap, two systematic reviews were performed which identified three instruments that had sufficient evidence of validity, reliability and feasibility to be considered for the final COS. RESULTS: At the fourth international HOME meeting, there was broad consensus among all stakeholders that the Patient-Oriented Eczema Measure (POEM) should be used as the core instrument (87·5% agreed, 9·4% unsure, 3·1% disagreed). CONCLUSIONS: All relevant stakeholders are encouraged to use POEM as the chosen instrument to measure the core domain of symptoms in all future AE clinical trials. Other instruments of interest can be used in addition to POEM.