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1.
Acta Derm Venereol ; 104: adv32323, 2024 May 13.
Artigo em Inglês | MEDLINE | ID: mdl-38738773

RESUMO

Recap of atopic eczema (RECAP) is a self-reported 7-item questionnaire recommended by the Harmonising Outcome Measures in Eczema initiative to measure eczema control. As RECAP has not been validated in a real-world clinical population in Asia, RECAP was investigated as a measure of eczema control in Singapore. Patients with atopic eczema at the National Skin Centre from July 2019 to January 2020 were included for analysis. Both patient- and physician-reported outcome measures were available for correlation analyses. Correlation analysis was also performed to investigate construct validity, and floor or ceiling effects of RECAP. A total of 260 atopic eczema patients aged between 15 and 87 years were recruited. There were minimal floor and ceiling effects for RECAP scores. There were strong, significant correlations of RECAP with POEM (r = 0.84, p < 0.001) and DLQI (r = 0.81, p < 0.001). Correlation with SCORAD was moderate (r = 0.60, p < 0.001). Correlations remained similar after age, gender, and ethnicity adjustments. Discriminative validity was demonstrated by a significant linear trend of increasing RECAP scores with increasing eczema severity. RECAP demonstrates good discriminative and construct validity evidenced by strong correlations with symptoms and quality of life and moderate correlations with eczema signs. RECAP is useful to measure eczema control in Singapore.


Assuntos
Dermatite Atópica , Qualidade de Vida , Índice de Gravidade de Doença , Humanos , Adulto , Feminino , Masculino , Pessoa de Meia-Idade , Singapura/epidemiologia , Dermatite Atópica/diagnóstico , Idoso , Adolescente , Adulto Jovem , Idoso de 80 Anos ou mais , Reprodutibilidade dos Testes , Medidas de Resultados Relatados pelo Paciente , Valor Preditivo dos Testes , Autorrelato
2.
BMC Anesthesiol ; 23(1): 344, 2023 10 14.
Artigo em Inglês | MEDLINE | ID: mdl-37838669

RESUMO

BACKGROUND: ICU survivors often suffer from prolonged physical and mental impairments resulting in the so called "Post-Intensive Care Syndrome" (PICS). The aftercare of former ICU patients affected by PICS in particular has not been addressed sufficiently in Germany so far. The aim of this study was to evaluate the feasibility of a pragmatic randomised trial (RCT) comparing an intensive care unit (ICU) follow-up clinic intervention to usual care. METHODS: This pilot study in a German university hospital evaluated the feasibility of a pragmatic RCT. Patients were assigned in a 1:1 ratio to an ICU follow-up clinic intervention or to usual care. The concept of this follow-up clinic was previously developed in a participatory process with patients, next of kin, health care professionals and researchers. We performed a process evaluation and determined acceptability, fidelity, completeness of measurement instruments and practicality as feasibility outcomes. The RCT's primary outcome (health-related quality of life) was assessed six months after ICU discharge by means of the physical component scale of the Short-Form-12 self-report questionnaire. RESULTS: The pilot study was conducted from June 2020 to May 2021 with 21 and 20 participants in the intervention and control group. Principal findings related to feasibility were 85% consent rate (N = 48), 62% fidelity rate, 34% attrition rate (N = 41) and 77% completeness of outcome measurements. The primary effectiveness outcome (health-related quality of life) could be measured in 93% of participants who completed the study (N = 27). The majority of participants (85%) needed assistance with follow-up questionnaires (practicality). Median length of ICU stay was 13 days and 85% (N = 41) received mechanical ventilation, median Sequential Organ Failure Assessment Score was nine. Six-month follow-up assessment was planned for all study participants and performed for 66% (N = 41) of the participants after 197 days (median). CONCLUSION: The participatory developed intervention of an ICU follow-up clinic and the pragmatic pilot RCT both seem to be feasible. We recommend to start a pragmatic RCT on the effectiveness of the ICU follow-up clinic. TRIAL REGISTRATION: ClinicalTrials.gov US NLM, NCT04186468, Submission: 02/12/2019, Registration: 04/12/2019, https://clinicaltrials.gov/ct2/show/NCT04186468.


Assuntos
Unidades de Terapia Intensiva , Qualidade de Vida , Humanos , Seguimentos , Estudos de Viabilidade , Projetos Piloto , Cuidados Críticos , Sobreviventes
3.
J Eur Acad Dermatol Venereol ; 37(6): 1199-1206, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-36695080

RESUMO

BACKGROUND: Hand eczema (HE) is a common skin disease characterized by itch, pain and visible skin changes such as fissures, erythema and vesicles. It is not yet clear which outcome domains are most important for patients. The Hand Eczema Core Outcome Set (HECOS) initiative is developing a consented set of core domains and suitable measurement instruments for the future application in all HE trials. This includes an online Delphi survey about core domains, which requires a 'Long List' of all domains that might be important to measure. OBJECTIVES: To compile a 'Long List' of candidate outcome domains for therapeutic HE trials with suggestions from patients and experts. METHODS: First, 60 patients with chronic HE were interviewed at seven study sites in Croatia, Denmark, Germany, the Netherlands and Spain. Patients were asked about domains that were important from their perspectives. Second, 185 HE experts were invited by email to complete an online survey. With an open question, they were asked to suggest up to six domains. RESULTS: Suggestions were provided by 58 patients and 82 experts. Most patients and experts suggested to measure the domains 'signs', 'symptoms' and 'HE-related quality of life'. Specifically, >25% of patients said that less itch, pain or fissures indicated a successful treatment. Among experts, >25% suggested 'itch' and 'ability to work' as core sub-domains. Further outcomes from the domains 'HE control over time', 'patient-reported treatment experience' and 'skin barrier function' were mentioned. CONCLUSION: 'Itch' was rated high among patients with HE and professional HE experts. While patients emphasized fissures as important, experts underlined the ability to work. This investigation allowed us to define a 'Long List' of 7 candidate outcome domains with 58 sub-domains. From this list, a panel of stakeholders will select core domains during an online Delphi survey.


Assuntos
Eczema , Qualidade de Vida , Humanos , Eczema/tratamento farmacológico , Prurido/tratamento farmacológico , Dor , Previsões , Técnica Delphi , Resultado do Tratamento
4.
J Allergy Clin Immunol ; 149(6): 1899-1911, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35351441

RESUMO

Core outcome sets are critically important outcomes that should be measured in clinical trials. Their absence in atopic dermatitis is a form of research waste and impedes combining evidence to inform patient care. Here, we articulate the rationale for core outcome sets in atopic dermatitis and review the work of the international Harmonising Outcome Measures for Eczema group from its inception in Munich, 2010. We describe core domain determination (what should be measured), to instrument selection (how domains should be measured), culminating in the complete core outcome measurement set in Tokyo, 2019. Using a "road map," Harmonising Outcome Measures for Eczema includes diverse research methods including Delphi and nominal group techniques informed by systematic reviews of properties of candidate instruments. The 4 domains and recommended instruments for including in all clinical trials of atopic dermatitis are patient symptoms, measured by Patient-Oriented Eczema Measure and peak Numerical Rating Scale 11 for itch intensity over 24 hours, clinical signs measured using the Eczema Area and Severity Index, quality of life measured by the Dermatology Life Quality Index series for adults, children, and infants, and long-term control measured by either Recap of atopic eczema or Atopic Dermatitis Control Tool.


Assuntos
Dermatite Atópica , Eczema , Adulto , Criança , Dermatite Atópica/diagnóstico , Dermatite Atópica/terapia , Humanos , Lactente , Avaliação de Resultados em Cuidados de Saúde , Qualidade de Vida , Índice de Gravidade de Doença
5.
Qual Life Res ; 31(3): 671-686, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-34327635

RESUMO

PURPOSE: To critically appraise, compare and summarize the quality of all existing PROMs that have been validated in hyperhidrosis to at least some extend by applying the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Thereby, we aim to give a recommendation for the use of PROMs in future clinical trials in hyperhidrosis. METHODS: We considered studies evaluating, describing or comparing measurement properties of PROMs as eligible. A systematic literature search in three big databases (MEDLINE, EMBASE and Web of Science) was performed. We assessed the methodological quality of each included study using the COSMIN Risk of Bias checklist. Furthermore, we applied predefined quality criteria for good measurement properties and finally, graded the quality of the evidence. RESULTS: Twenty-four articles reporting on 13 patient-reported outcome measures were included. Three instruments can be further recommended for use. They showed evidence for sufficient content validity and moderate- to high-quality evidence for sufficient internal consistency. The methodological assessment showed existing evidence gaps for eight other PROMs, which therefore require further validation studies to make an adequate decision on their recommendation. The Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) and the short-form health survey with 36 items (SF-36) were the only questionnaires not recommended for use in patients with hyperhidrosis due to moderate- to high-quality evidence for insufficient measurement properties. CONCLUSION: Three PROMs, the Hyperhidrosis Quality of Life Index (HidroQoL), the Hyperhidrosis Questionnaire (HQ) and the Sweating Cognitions Inventory (SCI), can be recommended for use in future clinical trials in hyperhidrosis. Results obtained with these three instruments can be seen as trustworthy. Nevertheless, further validation of all three PROMs is desirable. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020170247.


Assuntos
Hiperidrose , Qualidade de Vida , Lista de Checagem , Humanos , Hiperidrose/terapia , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida/psicologia , Inquéritos e Questionários
6.
Allergy ; 76(12): 3581-3588, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34022062

RESUMO

Research data derived from observational studies are accumulating quickly in the field of allergy and immunology and a large amount of observational studies are published every year. The aim of the present study was to evaluate the adherence to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist by papers published in the three European Academy of Allergy and Clinical Immunology journals, during the period 2009-2018. To this end, we conducted a bibliographic study of up to eight randomly selected papers per year per Journal. Our literature search resulted in 223 papers. Amongst those, 80, 80 and 63 records were from Paediatric Allergy and Immunology, Allergy and Clinical and Translational Allergy, respectively; the latter was published only from 2011 on. Prospective, case control and cross-sectional designs were described in 88, 43 and 92 papers, respectively. Full reporting of all STROBE items was present in 47.4%, 45.6% and 41.2% for the cohort, cross-sectional and case-control studies, respectively. Generally, no time trend in adherence of reporting STROBE items was observed, apart from reporting funding, which increased from 60% in 2009/2010 to more than 90% in 2018. We identified a cluster of STROBE items with low proportions of full reporting constituted by the items on reporting study design in the title and methods, variables types along with their measurement/assessment, bias and confounding, study size, and grouping of variables. It appears that the STROBE checklist is a suitable tool in observational allergy epidemiology. However, adherence to the STROBE checklist appeared suboptimal.


Assuntos
Lista de Checagem , Publicações Periódicas como Assunto , Criança , Estudos de Coortes , Estudos Transversais , Humanos , Estudos Prospectivos
7.
BMC Womens Health ; 21(1): 391, 2021 11 08.
Artigo em Inglês | MEDLINE | ID: mdl-34743728

RESUMO

BACKGROUND: Our aim was to gain insight into the experiences of women suffering from the urinary component of the Genitourinary Syndrome of Menopause (GSM) and to understand the impact of urinary complaints as part of GSM on the lives of affected women. DESIGN: Qualitative study. SETTING: Online, primary care. PARTICIPANTS AND METHODS: Postmenopausal women aged from 46 to 85 years reporting vaginal and urinary complaints were recruited to participate in either online or face-to-face focus groups to share their experiences with urinary complaints as part of GSM. Transcripts of sessions were analysed using qualitative content analysis. RESULTS: One online focus group, one face-to-face focus group and one online-interview were conducted, involving 11 women. Five a priori assumed main themes related to the impact of urogenital symptoms were identified: daily life, emotional well-being, sexual functioning, self-concept and body image, and interpersonal relations and communication. Additionally, two further themes associated with GMS as a clinical condition were inductively found: unmet healthcare needs, including expectations of affected women regarding menopausal symptoms and a lack of adequate health education, and aspects on the personal dealing with the complaints, including personal coping strategies and medical treatment. CONCLUSIONS: This study showed that urinary complaints as part of GSM have, similar to vaginal complaints, negative impacts on the daily life, the emotional well-being, the sexual functioning, the self-concept and body impact as well as interpersonal relations and communication of affected women. We further identified several unmet healthcare needs that should trigger improvements in healthcare.


Assuntos
Pós-Menopausa , Banheiros , Atrofia , Feminino , Humanos , Menopausa , Inquéritos e Questionários
8.
Contact Dermatitis ; 85(5): 489-493, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34161620

RESUMO

BACKGROUND: Hand eczema (HE) is a chronic inflammatory skin disease caused by a genetic predisposition and environmental exposures. There is a lack of population-based studies on skin diseases in the elderly. OBJECTIVES: Our aim was to estimate the frequency of HE in the elderly to determine its burden of disease in this particular population. METHODS: We analyzed data from the research platform AugUR, a study on chronic diseases in the elderly (n = 1133, ages 70-95 years, mean age 77.6, 45.1% women). Raw frequencies were estimated using self-reports on physician-diagnosed HE from a standardized personal interview. Frequencies were standardized to the Bavarian population weighted by gender and 5-year age-groups. RESULTS: In our sample 2.7% (95% confidence interval [CI] 1.6-4.3) of the paticipants reported to ever have been diagnosed with HE. Among those 57% were male. After standardization, the frequency was estimated at 2.8% (95% CI 1.9-3.9). There were no differences between male and female participants. CONCLUSIONS: Compared to other studies on lifetime frequency of HE, our estimates seem to be remarkably lower. More in-depth studies with validated diagnoses are warranted to precisely estimate the burden of HE in the elderly.


Assuntos
Eczema/epidemiologia , Avaliação Geriátrica/métodos , Dermatoses da Mão/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Doença Crônica/epidemiologia , Estudos Transversais , Dermatite Alérgica de Contato/epidemiologia , Feminino , Alemanha/epidemiologia , Humanos , Masculino , Prevalência , Fatores de Risco , Inquéritos e Questionários
9.
Acta Derm Venereol ; 99(13): 1210-1217, 2019 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-31502650

RESUMO

Assessment of the effectiveness of teledermatology has been hampered by the variety of outcome measures used, limiting the possibility for meta-analysis. This systematic mapping review classified the outcome measurement instruments used in randomized controlled trials of teledermatology conducted between 2008 and 2018 using the Core Outcome Measures in Effectiveness Trials taxonomy. Sixteen articles describing 12 studies were identified. Each trial used a mean of 3.7 outcome measurements (range 2-7) , with a total of 55 different instruments employed. Most instruments mapped on the "skin and subcutaneous tissue outcomes" domain. The most frequently used instrument (Dermatology Life Quality Index) was used in only 3 studies. Over 60% of the instruments used did not cite any evidence of validation. This mapping review provides a list of outcome measurement instruments that can be used as a resource when designing teledermatology trials in the future and provides the foundation for the development of a core outcome set.


Assuntos
Dermatologia/métodos , Avaliação de Resultados em Cuidados de Saúde , Telemedicina/organização & administração , Feminino , Alemanha , Humanos , Masculino , Ensaios Clínicos Controlados Aleatórios como Assunto , Dermatopatias/diagnóstico , Dermatopatias/terapia
10.
Cochrane Database Syst Rev ; 1: CD012167, 2019 Jan 22.
Artigo em Inglês | MEDLINE | ID: mdl-30666626

RESUMO

BACKGROUND: The symptoms of eczema can lead to sleeplessness and fatigue and may have a substantial impact on quality of life. Use of oral H1 antihistamines (H1 AH) as adjuvant therapy alongside topical agents is based on the idea that combining the anti-inflammatory effects of topical treatments with the blocking action of histamine on its receptors in the skin by H1 AH (to reduce the principal symptom of itch) might magnify or intensify the effect of treatment. Also, it would be unethical to compare oral H1 AH alone versus no treatment, as topical treatment is the standard management for this condition. OBJECTIVES: To assess the effects of oral H1 antihistamines as 'add-on' therapy to topical treatment in adults and children with eczema. SEARCH METHODS: We searched the following databases up to May 2018: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and the GREAT database (Global Resource of EczemA Trials; from inception). We searched five trials registers and checked the reference lists of included and excluded studies for further references to relevant randomised controlled trials (RCTs). We also searched the abstracts of four conference proceedings held between 2000 and 2018. SELECTION CRITERIA: We sought RCTs assessing oral H1 AH as 'add-on' therapy to topical treatment for people with eczema compared with topical treatment plus placebo or no additional treatment as add-on therapy. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. Primary outcome measures were 'Mean change in patient-assessed symptoms of eczema' and 'Proportion of participants reporting adverse effects and serious adverse events'. Secondary outcomes were 'Mean change in physician-assessed clinical signs', 'Mean change in quality of life', and 'Number of eczema flares'. MAIN RESULTS: We included 25 studies (3285 randomised participants). Seventeen studies included 1344 adults, and eight studies included 1941 children. Most studies failed to report eczema severity at baseline, but they were conducted in secondary care settings, so it is likely that they recruited patients with more severe cases of eczema. Trial duration was between three days and 18 months. Researchers studied 13 different H1 AH treatments. We could not undertake pooling because of the high level of diversity across studies in terms of duration and dose of intervention, concomitant topical therapy, and outcome assessment. Risk of bias was generally unclear, but five studies had high risk of bias in one domain (attrition, selection, or reporting bias). Only one study measured quality of life, but these results were insufficient for statistical analysis.Although this review assessed 17 comparisons, we summarise here the results of three key comparisons in this review.Cetirizine versus placeboOne study compared cetirizine 0.5 mg/kg/d against placebo over 18 months in 795 children. Study authors did not report patient-assessed symptoms of eczema separately for pruritus. Cetirizine is probably associated with fewer adverse events (mainly mild) (risk ratio (RR) 0.68, 95% confidence interval (CI) 0.46 to 1.01) and the need for slightly less additional H1 AH use as an indication of eczema flare rate (P = 0.035; no further numerical data given). Physician-assessed clinical signs (SCORing Atopic Dermatitis index (SCORAD)) were reduced in both groups, but the difference between groups was reported as non-significant (no P value given). Evidence for this comparison was of moderate quality.One study assessed cetirizine 10 mg/d against placebo over four weeks in 84 adults. Results show no evidence of differences between groups in patient-assessed symptoms of eczema (pruritus measured as part of SCORAD; no numerical data given), numbers of adverse events (RR 1.11, 95% CI 0.50 to 2.45; mainly sedation, other skin-related problems, respiratory symptoms, or headache), or physician-assessed changes in clinical signs, amount of local rescue therapy required, or number of applications as an indicator of eczema flares (no numerical data reported). Evidence for this comparison was of low quality.Fexofenadine versus placeboCompared with placebo, fexofenadine 120 mg/d taken in adults over one week (one study) probably leads to a small reduction in patient-assessed symptoms of pruritus on a scale of 0 to 8 (mean difference (MD) -0.25, 95% CI -0.43 to -0.07; n = 400) and a greater reduction in the ratio of physician-assessed pruritus area to whole body surface area (P = 0.007; no further numerical data given); however, these reductions may not be clinically meaningful. Results suggest probably little or no difference in adverse events (mostly somnolence and headache) (RR 1.05, 95% CI 0.74 to 1.50; n = 411) nor in the amount of 0.1% hydrocortisone butyrate used (co-intervention in both groups) as an indicator of eczema flare, but no numerical data were given. Evidence for this comparison was of moderate quality.Loratadine versus placeboA study of 28 adults compared loratadine 10 mg/d taken over 4 weeks versus placebo. Researchers found no evidence of differences between groups in patient-assessed pruritus, measured by a 100-point visual analogue scale (MD -2.30, 95% CI -20.27 to 15.67); reduction in physician-assessed clinical signs (SCORAD) (MD -4.10, 95% CI -13.22 to 5.02); or adverse events. Study authors reported only one side effect (folliculitis with placebo) (RR 0.25, 95% CI 0.01 to 5.76). Evidence for this comparison was of low quality. Number of eczema flares was not measured for this comparison. AUTHORS' CONCLUSIONS: Based on the main comparisons, we did not find consistent evidence that H1 AH treatments are effective as 'add-on' therapy for eczema when compared to placebo; evidence for this comparison was of low and moderate quality. However, fexofenadine probably leads to a small improvement in patient-assessed pruritus, with probably no significant difference in the amount of treatment used to prevent eczema flares. Cetirizine was no better than placebo in terms of physician-assessed clinical signs nor patient-assessed symptoms, and we found no evidence that loratadine was more beneficial than placebo, although all interventions seem safe.The quality of evidence was limited because of poor study design and imprecise results. Future researchers should clearly define the condition (course and severity) and clearly report their methods, especially participant selection and randomisation; baseline characteristics; and outcomes (based on the Harmonising Outcome Measures in Eczema initiative).


Assuntos
Eczema/tratamento farmacológico , Antagonistas dos Receptores Histamínicos H1/administração & dosagem , Administração Oral , Administração Tópica , Adulto , Cetirizina/administração & dosagem , Cetirizina/efeitos adversos , Quimioterapia Adjuvante , Criança , Antagonistas dos Receptores Histamínicos H1/efeitos adversos , Humanos , Loratadina/administração & dosagem , Loratadina/efeitos adversos , Avaliação de Resultados em Cuidados de Saúde , Prurido/tratamento farmacológico , Prurido/etiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Terfenadina/administração & dosagem , Terfenadina/efeitos adversos , Terfenadina/análogos & derivados
11.
Contact Dermatitis ; 80(1): 45-53, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30246346

RESUMO

BACKGROUND: The CARPE registry was set up in 2009 to prospectively investigate the management of patients with chronic hand eczema (CHE). OBJECTIVES: To report comprehensive follow-up data from the CARPE registry. PATIENTS AND METHODS: We investigated sociodemographic and clinical characteristics, provision of medical care, physician-assessed outcomes, and patient-reported outcomes (PROs). Data were collected between 2009 and 2016, with up to 5 years of follow-up, and are reported descriptively. RESULTS: Overall, 1281 patients were included in the registry (53.7% female). Mean age was 47.0 years. Of the patients, 793 and 231 completed the 2-year follow-up and 5-year follow-up, respectively. At baseline, 5.4% had changed or given up their job because of CHE, the average duration of CHE was 6.1 years, and, in 22.4%, the CHE was severe according to physician global assessment. Systemic treatment (alitretinoin, acitretin, and methotrexate) was prescribed at least once to 39.0% of the patients during the course of the follow-up. Disease severity, quality of life and treatment satisfaction improved over time, and the proportion of patients receiving systemic treatments decreased. CONCLUSIONS: Under continued dermatological care, substantial improvements in disease severity and PROs over time was achieved during the course of the CARPE registry, even in patients with long-standing and severe hand eczema.


Assuntos
Dermatite Alérgica de Contato/fisiopatologia , Dermatoses da Mão/fisiopatologia , Sistema de Registros , Acitretina/uso terapêutico , Administração Cutânea , Adolescente , Corticosteroides/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Alitretinoína/uso terapêutico , Doença Crônica , Dermatite Alérgica de Contato/etiologia , Dermatite Alérgica de Contato/terapia , Fármacos Dermatológicos/uso terapêutico , Eczema/fisiopatologia , Feminino , Seguimentos , Dermatoses da Mão/terapia , Humanos , Masculino , Metotrexato/uso terapêutico , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Terapia PUVA , Medidas de Resultados Relatados pelo Paciente , Terapia Ultravioleta , Ureia/uso terapêutico , Adulto Jovem
14.
J Asthma ; 53(4): 427-37, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26786054

RESUMO

OBJECTIVE: We aimed to develop and tentatively validate an instrument assessing patients' needs related to asthma treatment. METHODS: Patients were recruited through various approaches (e.g. physicians, pharmacies and patient organizations). Utilizing a mixed methods design, we first conducted five focus groups to explore needs among patients. Next, we devised an item pool which was revised, reduced and evaluated by patients. Finally, data from a survey (n = 362) were used to further reduce the item pool and to examine the questionnaire's psychometric properties and validity. RESULTS: Four broad needs categories emerged from the focus groups: (1) information needs; (2) consideration of patient views in diagnosis; (3) consideration of patient views in treatment planning; and (4) addressing patients' fears. We devised 45 items, which were reduced to 22 items based on patient feedback. The survey data suggested a 13-item scale with four subscales ("patient expertise", "drug effects", "handling drugs" and "exacerbations"). Cronbach's alpha was acceptable for those subscales (>0.7) and for the total score (0.9). Increasing scores on subscales and the total score (implying more unmet needs) showed close and consistent associations with poor asthma control, reduced quality of life and low treatment satisfaction. CONCLUSIONS: The development process of the Needs in Asthma Treatment (NEAT) questionnaire ensured that needs of asthma patient are captured with high validity. The NEAT questionnaire has been shown to be valid, thereby representing a promising tool for research and delivery of patient-centered care.


Assuntos
Asma/terapia , Necessidades e Demandas de Serviços de Saúde/estatística & dados numéricos , Inquéritos e Questionários , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
15.
Acta Derm Venereol ; 96(5): 596-601, 2016 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-26676847

RESUMO

It is unclear which quality of life instruments have thus far been used in eczema trials. Therefore, we aimed to identify these instruments. We searched the Global Resource of Eczema Trials (GREAT) database for reports of randomized controlled trials. Information on patient-reported outcomes, particularly quality of life, was extracted from eligible studies. 287 full texts reporting on 303 trials and 72 abstracts were included. 63/303 studies (20.8%) assessed quality of life and used 18 named and 4 unnamed instruments. The Dermatology Life Quality Index (DLQI), the Children's Dermatology Life Quality Index (CDLQI), the Infant's Dermatitis Quality of Life Index (IDQOL), and the Dermatitis Family Impact (DFI) were the most common measures in adults, children, infants, and caregivers, respectively. In conclusion, only about one fifth of eczema trials include a quality of life measure as outcome. Many different instruments are used, limiting the possibilities of comparing and synthesising individual trials' findings.


Assuntos
Eczema/psicologia , Eczema/terapia , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Índice de Gravidade de Doença , Inquéritos e Questionários
16.
Acta Derm Venereol ; 94(6): 658-62, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-24604210

RESUMO

Health-related quality of life (HRQOL) has become an important patient reported outcome in health service research. The dermatology life quality index (DLQI) is the most commonly used instrument in dermatology. In recent years, the psychometric properties of the DLQI have been a subject of debate as requirements of modern test theory seem not to be fulfilled. The aim of this study was to test whether those violations also occur in patients with hand eczema. We collected data of 602 hand eczema patients who participated in an inpatient dermatology rehabilitation program in Germany. In order to report meaningful scores of the DLQI, data were analysed according to the principles of modern test theory. We calibrated the DLQI using the Rasch model, resulting in a 6 item version with a range between 0-15 points. This version showed no significant misfit to the Rasch model (p>0.14). By using a Rasch analysis the results were evaluated in a second sample of hand eczema patients (n=511). Even if all demographic characteristic of this sample were different, we were able to replicate the results found in this study (p>0.21). In conclusion, we recommend to use an alternative scoring procedure as presented in this article if the DLQI is used in hand eczema patients.


Assuntos
Eczema/diagnóstico , Dermatoses da Mão/diagnóstico , Pacientes Internados/psicologia , Psicometria , Qualidade de Vida , Inquéritos e Questionários , Adolescente , Adulto , Idoso , Eczema/psicologia , Eczema/reabilitação , Feminino , Alemanha , Dermatoses da Mão/psicologia , Dermatoses da Mão/reabilitação , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Adulto Jovem
17.
Cochrane Database Syst Rev ; (5): CD007676, 2014 May 19.
Artigo em Inglês | MEDLINE | ID: mdl-24842151

RESUMO

BACKGROUND: Psychological stress has been widely implicated in asthma exacerbation. Evidence suggests that written emotional disclosure, an intervention that involves writing about traumatic or stressful experiences, helps to reduce stress and promote physical and psychological well-being. Written emotional disclosure may have a role in the management of asthma. OBJECTIVES: This review aims to determine the effectiveness of written emotional disclosure for people with asthma, specifically, to assess:1. overall efficacy of emotional disclosure compared with emotionally neutral writing on self reported quality of life in people with asthma;2. overall efficacy of emotional disclosure compared with emotionally neutral writing on objective measures of health outcome in people with asthma; and3. comparative efficacy of different types of emotional disclosure for people with asthma. SEARCH METHODS: Trials were identified from the Cochrane Airways Group Specialised Register of trials, CENTRAL, MEDLINE, EMBASE, CINAHL, AMED and PsycINFO. The latest search was conducted in January 2014. SELECTION CRITERIA: Randomised controlled trials published in any language comparing written emotional disclosure intervention versus a control writing (emotionally neutral) intervention in participants with asthma were included in the review. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies against predetermined inclusion criteria and extracted the data. Corresponding authors were contacted when necessary to provide additional information. MAIN RESULTS: Four studies, involving a total of 414 participants, met the inclusion criteria. Three studies were conducted in adult participants and one in adolescents. The average age of participants ranged from 14 to 43 years. The trials lasted between two months and 12 months. The interventions were based on Pennebaker's method. The risk of bias across most domains of the studies was generally considered to be low, however three of four studies were considered at high risk of bias due to lack of assessor blinding and one study was at high risk of bias for selective reporting. The interpretation of these studies was limited by diverse outcome measurements, measurement tools, control group techniques, and number and/or times of follow-up. A pooled result from the four studies, including a total of 146 intervention and 135 control participants, indicated uncertain effect in forced expiratory volume in one second (FEV1) % predicted between the disclosure group and the control group (mean difference (MD) 3.43%, 95% confidence interval (CI) -0.61% to 7.47%; very low-quality evidence) at ≤ three months' follow-up. Similarly, evidence from two studies indicated that written emotional disclosure found uncertain effect on forced vital capacity (FVC) (standardised mean difference (SMD) -0.02, 95% CI -0.30 to 0.26; low-quality evidence) and asthma symptoms (SMD -0.22, 95% CI -0.52 to 0.09; low-quality evidence) but may result in improved asthma control at ≤ three months' follow-up (SMD 0.29, 95% CI 0.01 to 0.58; low-quality evidence). We were unable to pool the data for other outcomes. Results from individual trials did not reveal a significant benefit of written emotional disclosure for quality of life, medication use, healthcare utilisation or psychological well-being. Evidence from one trial suggests a significant reduction in beta agonist use (MD -1.62, 95% CI -2.62 to -0.62; low-quality evidence) at ≤ three months' follow-up in the disclosure group compared with controls. The review did not address any adverse effects of emotional writing. AUTHORS' CONCLUSIONS: Evidence was insufficient to show whether written emotional disclosure compared with writing about non-emotional topics had an effect on the outcomes included in this review. Evidence is insufficient to allow any conclusions as to the role of disclosure in quality of life, psychological well-being, medication use and healthcare utilisation. The evidence presented in this review is generally of low quality. Better designed studies with standardised reporting of outcome measurement instruments are required to determine the effectiveness of written emotional disclosure in the management of asthma.


Assuntos
Asma/psicologia , Revelação , Psicoterapia/métodos , Estresse Psicológico/terapia , Redação , Adolescente , Adulto , Asma/terapia , Volume Expiratório Forçado , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
18.
PLoS One ; 19(7): e0303344, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38959206

RESUMO

BACKGROUND: The SARS-CoV-2 pandemic presented a challenge for caregiving relatives in the home care setting. Caregivers can transmit SARS-CoV-2 to their relatives who are often at high risk for a severe course of COVID-19. Regular testing of asymptomatic caregivers for SARS-CoV-2 may reduce the risk of transmission. The optimal method and frequency of regular asymptomatic testing is unknown. We conducted a prospective, randomised trial to assess the feasibility, recruitment and acceptance of different testing frequencies. This serves to inform a future definitive randomised controlled trial. METHODS: We carried out a parallel three-armed feasibility trial, enrolling adult participants who provided home-based care for a relative at least twice a week. Participants were randomly assigned using sealed envelopes to either conduct saliva-based antigen self-testing at a frequency of once a week (group I), twice a week (group II), or every two days (group III). The participants completed questionnaires on a weekly basis. Main outcome measures were feasibility of recruitment, adherence to self-tests and distress caused by self-testing. We further collected data on the use of mouth-nose mask. RESULTS: From 25 March to 7 May 2021 we assessed 27 participants and randomised 26 in the study: 8 participants in group I, 8 in group II and 10 in group III. All participants completed the study. In group I 48/48 (100.0%; 95% CI 92.6% to 100.0%), in group II 93/96 (96.9%; 95% CI 91.2% to 98.9%) and in group III 209/210 (99.5%; 95% CI 97.4% to 99.9%) self-tests were carried out at home. Participants did not perceive regular self-testing as burdensome in any of the study arms. We did not observe any infection with SARS-CoV-2. During the study, mask adherence decreased from 35% to 19% in all groups. CONCLUSION: Conducting such a study was feasible. The participants tolerated regular self-testing well, which was reflected in a high level of test adherence. However, regular self-testing may have led to decreased protective behaviour. To demonstrate that regular asymptomatic testing reduces infection transmission, a future definitive trial should be performed at a time of a high prevalence of SARS-CoV-2 and be implemented as a multicentre study. TRIAL REGISTRATION: The trial is registered with the German Clinical Trials Register, DRKS00026234.


Assuntos
COVID-19 , Estudos de Viabilidade , Serviços de Assistência Domiciliar , SARS-CoV-2 , Autoteste , Humanos , COVID-19/diagnóstico , COVID-19/epidemiologia , COVID-19/prevenção & controle , Feminino , Masculino , Pessoa de Meia-Idade , SARS-CoV-2/isolamento & purificação , Adulto , Cuidadores , Idoso , Saliva/virologia , Estudos Prospectivos , Infecções Assintomáticas/epidemiologia
19.
Sci Rep ; 14(1): 11829, 2024 05 23.
Artigo em Inglês | MEDLINE | ID: mdl-38783013

RESUMO

Sports activities can lead to exercise-related skin complaints. These include different symptoms (e.g. infections, mechanical injuries, contact dermatitis). Previous studies mostly focused only on skin infections and injuries in competitive athletes. The purpose of this study was to determine the frequency and characteristics of exercise-related skin complaints among sports students and to what extent these complaints influence physical fitness. We performed a self-administered online survey among 259 actively exercising sports students from two German universities. Descriptive analyses were conducted. The most common complaints were blistering (57.3%), dryness (56.7%), redness (44.7%), and chafing (34.0%). Hands and feet (78.0% each) were most frequently affected. Participants whose skin was particularly stressed (47.5%) had higher training duration (7.6 h/week, 95%-CI 6.8-8.3 h) than those without complaints (5.1 h/week, 95%-CI 5.5-6.7 h, p = 0.003). The students reported reduced intensity (34.7%) and frequency (22.7%) of training due to their skin complaints. A reduction in performance was reported by 32.0% of the students. Actively exercising sports students considered an intact skin as essential for their physical fitness. Reported impairments of the skin led to a reduced intensity and frequency of training. To enhance the awareness of exercise-related skin complaints, further research is necessary.


Assuntos
Exercício Físico , Estudantes , Humanos , Masculino , Feminino , Alemanha/epidemiologia , Universidades , Estudos Transversais , Adulto Jovem , Adulto , Dermatopatias/epidemiologia , Esportes , Atletas/estatística & dados numéricos , Inquéritos e Questionários , Adolescente , Pele , Aptidão Física
20.
Acta Derm Venereol ; 93(5): 532-7, 2013 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-23450324

RESUMO

Epidemiological data on chronic pruritus (> 6 weeks) in the general population are sparse. We aimed to provide data on the incidence and prevalence of chronic pruritus, and identify its determinants based on cross-sectional and longitudinal analyses. A cohort of 1,190 participants from a cross-sectional baseline-study (response rate: 57.8%) was followed up after one year. The questionnaire assessed occurrence of chronic pruritus, medical, lifestyle and psychosocial variables. Incident chronic pruritus was defined as reported chronic pruritus at follow-up in those subjects free-of-the-symptom at baseline. Cross-sectional analyses of data from the follow-up assessments addressed potential associations of medical, lifestyle and psychosocial factors with prevalent chronic pruritus. Longitudinal analyses examined sociodemographic factors as potential predictors of incident chronic pruritus. The follow-up response rate was 83.1%. The mean age of subjects was 56 years, and 58% were female. The 12-month cumulative-incidence equalled 7.0% (95% confidence interval (95% CI) 5.2-9.2%. Lifetime prevalence was 25.5% (95% CI 21.8-27.8%). Incidence was significantly associated with age. Determinants of prevalent chronic pruritus in multi-variable analyses were: liver disease, asthma, eczema and dry skin within the medical domain, an elevated body mass index within the lifestyle domain and higher anxiety scores within the psychosocial domain. Findings suggest a considerable 12-month incidence and lifetime prevalence and provide important directions for future research.


Assuntos
Prurido/epidemiologia , Fatores Etários , Distribuição de Qui-Quadrado , Doença Crônica , Comorbidade , Estudos Transversais , Feminino , Alemanha/epidemiologia , Humanos , Incidência , Estilo de Vida , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Razão de Chances , Prevalência , Prognóstico , Prurido/diagnóstico , Prurido/terapia , Fatores de Risco , Inquéritos e Questionários , Fatores de Tempo
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