Effectiveness of alpine climate treatment for children with difficult to treat atopic dermatitis: Results of a pragmatic randomized controlled trial (DAVOS trial).

BACKGROUND: Alpine climate treatment has historically been used in Europe to treat atopic dermatitis (AD), but no randomized trials have been conducted to provide evidence for its effectiveness. OBJECTIVE: To investigate the long-term effectiveness of alpine climate treatment for children with difficult to treat AD. MATERIALS & METHODS: A pragmatic, open, randomized controlled trial was conducted. Children diagnosed with AD that was considered difficult to treat, aged between 8 and 18 years and willing to be treated in Switzerland were randomized to a six-week personalized integrative multidisciplinary treatment period in a clinical setting in the alpine climate (Switzerland) or an outpatient setting in moderate maritime climate (Netherlands). Study assessments were conducted at the Wilhelmina Children's Hospital; an electronic portal was used for the collection of questionnaire data. Primary outcomes were disease activity (SAEASI), quality of life (CDLQI) and catastrophizing thoughts (JUCKKI/JU) 6 months after intervention. Other assessments were immediately and 6 weeks after intervention. Subgroup analyses concerned asthma-related outcomes. Children were randomly assigned to either the intervention or control group using a covariate adaptive randomization method, taking age and asthma diagnosis into account. Children, parents and healthcare professionals involved in treatment were not blinded to group assignment. Data were analysed according to intention-to-treat with linear mixed-effects models for continuous outcomes. The trial is registered at Current Controlled Trials ISCRTN88136485. RESULTS: Between 14 September 2010 and 30 September 2014, 88 children were enrolled in the trial, 84 children were randomized (41 assigned to intervention, 43 to control) of whom 77 completed the intervention (38 of 41 (93%) intervention, 39 of 43 (91%) control) and 74 completed follow-up (38 of 41 (93%) intervention, 36 of 43 (84%) control). Six months after intervention there were no significant differences between the groups on disease activity (SAEASI mean difference -3.4 (95%CI -8.5 to 1.7)), quality of life (CDLQI mean difference -0.3 (95%CI -2.0 to 1.4)) and catastrophizing thoughts (JUCCKI/JU subscale mean difference -0.7 (95%CI -1.4 to -0.0)). Immediately and 6 weeks after intervention, disease activity and quality of life were significantly different in favour of alpine climate treatment. Mean differences on SAEASI were -10.1 (95%CI -14.5 to -5.8) and -8.4 (95%CI -12.2 to -4.6) and on CDLQI -1.9 (95%CI -3.3 to -0.5) and -1.5 (95%CI -2.8 to -0.3) immediately and 6 weeks after the intervention, respectively. There were no long-term differences on asthma-related outcomes. Five serious adverse events occurred during the study period, which were not thought to be related to the treatment. CONCLUSIONS & CLINICAL RELEVANCE: For children with difficult to treat AD, there was no additional long-term benefit of alpine climate treatment, in contrast to the short-term, compared to an outpatient treatment programme in moderate maritime climate, using a personalized integrative multidisciplinary treatment approach.

Assessment of validity and reliability of Drug Hypersensitivity Quality of Life Questionnaire: The Dutch experience.

SUMMARY: Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q) is the first questionnaire that captures health related quality of life impact in patients with drug hypersensitivity. The aim of this study was to translate and validate the original Italian 15-item DrHy-Q for use among Dutch-speaking residents. We also compared the DrHy-Q scores obtained across countries. In a prospective cohort study, the Dutch DrHy-Q was completed by 124 patients (65.3% female, age 56.8 ± 14.0) with a confirmed drug hypersensitivity. Median DrHy-Q score was 12 [0-88]. Validity and reliability of the DrHy-Q was confirmed through, 1, confirmatory factor analysis; 2, concurrent validity with a generic health related quality of life questionnaire (RAND-36); 3, internal consistency; and 4, test-retest reliability. A country specific difference in scores was observed.

Diagnostic accuracy of specific IgE to components in diagnosing peanut allergy: a systematic review.

The diagnostic accuracy of skin prick test (SPT) and specific IgE (sIgE) to peanut extract in diagnosing peanut allergy is suboptimal. Recent studies have evaluated sIgE to peanut components as a possible new diagnostic tool. The aim of our review was to systematically search the literature to assess the diagnostic value of sIgE to peanut components in diagnosing peanut allergy. A literature search was performed in PubMed, Embase and the Cochrane Library. Results were subsequently screened for in- and exclusion criteria. The quality of eligible studies was assessed using a standardized quality assessment tool (QUADAS-2). Data on sensitivity, specificity, and positive and negative likelihood ratios were extracted or calculated for a descriptive analysis. Twenty-two studies were eligible, of which 21 studies in paediatric populations. Most studies reported on sIgE to peanut extract (15) and sIgE to Ara h 2 (12), followed by SPT (9) and sIgE to Ara h 1 (7). All studies were at risk of bias or caused applicability concerns on at least one item of the quality assessment tool. The best combination of diagnostic accuracy measures of all diagnostic tests was found for sIgE to Ara h 2. This finding was independent of geographical location. Compared to SPT and sIgE to peanut extract, sIgE to Ara h 2 was mainly superior in diagnosing peanut allergy in case of a positive test result. Worst diagnostic accuracy measures were found in general for sIgE to Ara h 8 and sIgE to Ara h 9. sIgE to Ara h 2 showed the best diagnostic accuracy of all diagnostic tests to diagnose peanut allergy. Compared to the currently used SPT and sIgE to peanut extract, sIgE to Ara h 2 was superior in diagnosing peanut allergy and should therefore replace these tests in daily clinical practice, especially in children.

Frequency, severity and causes of unexpected allergic reactions to food: a systematic literature review.

Food allergic patients have to deal with an avoidance diet. Confusing labelling terms or precautionary labels can result in misinterpretation and risk-taking behaviour. Even those patients that strictly adhere to their diet experience (sometimes severe) unexpected allergic reactions to food. The frequency, severity and causes of such reactions are unknown. The objective of this review was to describe the frequency, severity and causes of unexpected allergic reactions to food in food allergic patients aged > 12 years, in order to develop improved strategies to deal with their allergy. A systematic review was carried out by two researchers, in six electronic databases (CINAHL, Cochrane, EMBASE, Medline, Psychinfo and Scopus). The search was performed with keywords relating to the frequency, severity and causes of unexpected allergic reactions to food. This resulted in 24 studies which met the inclusion criteria; 18 observational and six qualitative studies. This review shows that knowledge about the frequency of unexpected reactions is limited. Peanut, nuts, egg, fruit/vegetables and milk are the main causal foods. Severe reactions and even fatalities occur. Most reactions take place at home, but a significant number also take place when eating at friends' houses or in restaurants. Labelling issues, but also attitude and risky behaviour of patients can attribute to unexpected reactions. We conclude that prospective studies are needed to get more insight in the frequency, severity, quantity of unintended allergen ingested and causes of unexpected allergic reactions to food, to be able to optimize strategies to support patients in dealing with their food allergy. Although the exact frequency is not known, unexpected reactions to food occur in a significant number of patients and can be severe. For clinical practice, this means that patient education and dietary instructions are necessary.

EAACI food allergy and anaphylaxis guidelines: managing patients with food allergy in the community.

The European Academy of Allergy and Clinical Immunology (EAACI) Food Allergy and Anaphylaxis Guidelines, managing patients with food allergy (FA) in the community, intend to provide guidance to reduce the risk of accidental allergic reactions to foods in the community. This document is intended to meet the needs of early-childhood and school settings as well as providers of non-prepackaged food (e.g., restaurants, bakeries, takeaway, deli counters, and fast-food outlets) and targets the audience of individuals with FA, their families, patient organizations, the general public, policymakers, and allergists. Food allergy is the most common trigger of anaphylaxis in the community. Providing children and caregivers with comprehensive information on food allergen avoidance and prompt recognition and management of allergic reactions are of the utmost importance. Provision of adrenaline auto-injector devices and education on how and when to use these are essential components of a comprehensive management plan. Managing patients at risk of anaphylaxis raises many challenges, which are specific to the community. This includes the need to interact with third parties providing food (e.g., school teachers and restaurant staff) to avoid accidental exposure and to help individuals with FA to make safe and appropriate food choices. Education of individuals at risk and their families, their peers, school nurses and teachers as well as restaurant and other food retail staff can reduce the risk of severe/fatal reactions. Increased awareness among policymakers may improve decision-making on legislation at local and national level.

A systematic review of the effect of thermal processing on the allergenicity of tree nuts.

BACKGROUND: Allergenicity of foods can be influenced by processing. Tree nuts are an important source of nutrition and increasingly consumed; however, processing methods are quite variable and data are currently lacking on the effects of processing on allergenicity. OBJECTIVE: To perform a systematic literature review on the effects of food processing on the allergenicity of tree nuts. METHODS: A systematic literature search of PubMed and Embase databases was performed, with screening of references, related articles and citations. Studies were included if they assessed the allergenicity or immunogenicity of processed nuts. RESULTS: The search resulted in 32 articles suitable for analysis. Clinical studies indicate that roasting reduces the allergenicity of hazelnut in individuals with a birch pollen allergy and reactivity to raw hazelnut. Thermal processing may reduce the allergenicity of the PR-10 protein in hazelnut and almond in vitro. The majority of the in vitro studies investigating the allergenicity of nonspecific lipid transfer proteins (nsLTPs) and seed storage proteins in hazelnut, almond, cashew nut, Brazil nut, walnut, pecan nut and pistachio nut show heat stability towards different thermal processing methods. CONCLUSION: Thermal processing may reduce allergenicity of PR-10 proteins in hazelnut and almond, in contrast to nsLTPs and seed storage proteins. This has important implications for source materials used for IgE testing and food challenges and diet advice.

E-health in caring for patients with atopic dermatitis: a randomized controlled cost-effectiveness study of internet-guided monitoring and online self-management training.

BACKGROUND: The Dermatology Department of the University Medical Centre Utrecht, the Netherlands, developed an e-health portal for patients with atopic dermatitis (AD), consisting of e-consultation, a patient-tailored website, monitoring and self-management training. OBJECTIVES: To determine the cost-effectiveness of individualized e-health compared with usual face-to-face care for children and adults with AD. METHODS: A randomized controlled cost-effectiveness study from a societal perspective in adults and parents of children with moderate AD. Outcomes were quality of life, severity of AD, itching and direct and indirect costs. Data were collected at baseline and at 3 and 12 months after randomization. Linear mixed models were used to analyse clinical outcomes. After multiple imputation of missing data, costs and differences in costs were calculated over a period of 1 year. RESULTS: In total, 199 patients were included. There were no significant differences in disease-specific quality of life, severity of AD and intensity of itching between both groups at the three time points. The difference in direct costs between the intervention and control groups was €24 [95% confidence interval (CI) -360 to 383], whereas this difference was -€618 (95% CI -2502 to 1143) for indirect costs. Overall, individual e-health was expected to save €594 (95% CI -2545 to 1227) per patient in the first year of treatment, mainly through a reduction in work absenteeism. Uncertainty analyses revealed that the probability of e-health reducing costs was estimated to be ≥ 73%. CONCLUSIONS: E-health during follow-up of patients with AD is, after initial diagnosis and treatment during face-to-face contact, just as effective as usual face-to-face care with regard to quality of life and severity of disease. However, when costs are considered, e-health is likely to result in substantial cost savings. Therefore, e-health is a valuable service for patients with AD.

Efficacy of Treatment of Non-hereditary Angioedema.

Non-hereditary angioedema (AE) with normal C1 esterase inhibitor (C1INH) can be presumably bradykinin- or mast cell-mediated, or of unknown cause. In this systematic review, we searched PubMed, EMBASE, and Scopus to provide an overview of the efficacy of different treatment options for the abovementioned subtypes of refractory non-hereditary AE with or without wheals and with normal C1INH. After study selection and risk of bias assessment, 61 articles were included for data extraction and analysis. Therapies were described for angiotensin-converting enzyme inhibitor-induced AE (ACEi-AE), for idiopathic AE, and for AE with wheals. Described treatments consisted of ecallantide, icatibant, C1INH, fresh frozen plasma (FFP), tranexamic acid (TA), and omalizumab. Additionally, individual studies for anti-vitamin K, progestin, and methotrexate were found. Safety information was available in 26 articles. Most therapies were used off-label and in few patients. There is a need for additional studies with a high level of evidence. In conclusion, in acute attacks of ACEi-AE and idiopathic AE, treatment with icatibant, C1INH, TA, and FFP often leads to symptom relief within 2 h, with limited side effects. For prophylactic treatment of idiopathic AE and AE with wheals, omalizumab, TA, and C1INH were effective and safe in the majority of patients.

[Does the patient benefit from real-time access to one's electronic record? Evaluation of the patient portal in University Medical Centre Utrecht, the Netherlands]. / Is patiënt gebaat bij directe inzage in zijn dossier?

OBJECTIVE: Evaluation of the use of the UMC Utrecht patient portal, which offers patients real-time access to their hospital electronic medical record, by healthcare providers and patients. DESIGN: Questionnaires and focus group. METHOD: We conducted a single questionnaire survey among healthcare providers (doctors, nurses, secretaries and doctors' assistants) in June 2015, covering topics such as usage of the portal, its user friendliness, and any impact on patient contact and work. Patients - both users and non-users - were surveyed in August 2015. Furthermore, a focus group interview took place with healthcare providers, based on results of the preceding questionnaire. RESULTS: Healthcare providers were familiar with the portal and recognised the importance of sharing medical information with the patient. The portal was technically implemented; however, its use was still low and the portal was not fully embedded in daily practice. Patients using the portal appreciated the rapid access to medical information and the ability to be involved in their own care. An important point of attention was the real-time access to results from diagnostic testing. CONCLUSION: To prevent anxiety in patients and incorrect interpretation of diagnostic results due to use of the patient portal, it is essential to prepare the patient for real-time viewing and to make timely arrangements for discussion of the results and implications for treatment. Future evaluations will follow in order to use the experiences of healthcare providers and patients for further optimisation of this hospital patient portal.

Costs and cost-effectiveness of the nursing programme 'Coping with itch' for patients with chronic pruritic skin disease.

BACKGROUND: Itch, a major symptom of many skin diseases, has a great impact on quality of life. The nursing programme 'Coping with itch' aims at reducing itch and at helping patients to cope with itch. OBJECTIVES: To explore costs and cost-effectiveness of the programme. METHODS: A randomized controlled study was carried out with 56 patients. Data were gathered on medical consumption, days off work and the frequency of itching and scratching. Differences between both groups, the cost-effectiveness ratio and the percentage of patients falling into the four quadrants of the cost-effectiveness analysis plane were determined. RESULTS: The intervention group experienced a gain of 6 days with little itching [95% confidence interval (CI) -16-28] at 3 months and a gain of 35 days (95% CI -33-96) at 9 months. They paid more visits to the dermatology nurse than the control group. The point estimate of the incremental cost-effectiveness ratio was euro129.91 and euro16.60 per day with little itching at 3 months and at 9 months, respectively. At 3 months, 70% of the patients experienced favourable results and 14% of them had lower costs. At 9 months, 87% had favourable results and 31% of them had lower costs. CONCLUSIONS: Most of the expenses associated with the 'Coping with itch' programme were incurred during the first 3 months, but the benefits in terms of days with little itch appeared to persist and increase beyond 3 months, thus leading to a more favourable incremental cost-effectiveness ratio.

Effectiveness of the nursing programme 'Coping with itch': a randomized controlled study in adults with chronic pruritic skin disease.

BACKGROUND: The nursing programme 'Coping with Itch' aims at reducing itch and at helping patients with chronic pruritic skin diseases cope with itch. The programme consists of educational and cognitive behavioural interventions. Dermatology nurses carry out the programme, which supplements standard medical treatment given by a dermatologist, in individual sessions at a nurse clinic organized by the dermatology outpatient department. OBJECTIVES: To evaluate the effectiveness of the nursing programme 'Coping with Itch' in patients with chronic pruritic skin diseases. METHODS: A randomized controlled study was carried out. Patients with chronic pruritic skin diseases were randomly assigned to the intervention group or the control group. The intervention group received standard care from a dermatologist and nursing care according to the programme 'Coping with Itch' for a mean of 2.9 visits. The control group received usual care from a dermatologist. Data collection took place at baseline, at 3 months (t1) and at 9 months (t2) after baseline. Most visits to the nurse clinic took place during the first 3 months of the study. Main outcome measures were the frequency and intensity of itching and scratching, itch-related coping, and skin-related and general psychosocial morbidity. Secondary outcome measures were the number of visits to the dermatologist and the use of medication and ointments. Mann-Whitney tests and analyses of covariance were used to analyse differences between the two groups. RESULTS: Data on 29 patients in the intervention group and 36 patients in the control group were used in the analyses. A trend to significance (P = 0.07) was shown in the difference between the two groups in the frequency of itching and scratching at t1. A significant difference (P = 0.04) was shown between the two groups in catastrophizing and helpless itch-related coping at t1. No significant differences were revealed at t2 between the groups. Patients in the intervention group visited the dermatologist significantly less frequently during the intervention period than did control group patients. CONCLUSIONS: The nursing programme 'Coping with Itch' led to a reduction in the frequency of itching and scratching and to a reduction of catastrophizing and helpless coping in patients with chronic pruritic skin diseases during the period immediately following the intervention. We suggest further follow-up visits to the itch clinic to extend these results over a longer period.

Prevalence and predictors of psychosocial morbidity in patients with chronic pruritic skin diseases.

BACKGROUND: Itch is a major symptom of many skin diseases and causes patients considerable distress, adversely affecting quality of life. Feelings of helplessness and lack of control can influence the perceived itch and psychosocial complaints. OBJECTIVES: To determine the prevalence of psychosocial morbidity among patients with pruritic skin diseases, and the influence of itch-related variables, coping strategies, and demographic variables on psychosocial morbidity. PATIENTS AND METHODS: One hundred and sixty-eight patients with pruritic skin diseases from five hospitals in the Netherlands participated in the study. Skin-related psychosocial morbidity was measured with the Adjustment to Chronic Skin Diseases questionnaire (ACS); general psychosocial morbidity was measured with the Symptom Checklist-90 (SCL-90). The frequency and intensity of itching and scratching was recorded in diaries. Itch-related coping was measured with the Itching Cognitions Questionnaire (ICQ). Multiple regression analyses were used. RESULTS: Patients with pruritic skin diseases had higher SCL-90 scores than a healthy Dutch population. All patients had psychosocial complaints as measured with the ACS. Thirty-nine per cent of the variance in skin-related psychosocial morbidity was explained by 'catastrophizing and helpless coping'; another 11% was explained by itching and scratching. Age and sex together explained another 10%. The frequency of itching and scratching (11%), 'catastrophizing and helpless coping' (19%) and skin-related psychosocial morbidity (10%) explained the variance in general psychosocial morbidity. CONCLUSIONS: Patients with a pruritic skin disease have a high level of psychosocial morbidity. Catastrophizing and helpless coping are the most important predictors of psychosocial morbidity, with itching, scratching and demographic variables having a limited influence.