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The coronavirus disease 2019 (COVID-19) pandemic substantially impacted different age groups, with children and young people not exempted. Many have experienced enduring health consequences. Presently, there is no consensus on the health outcomes to assess in children and young people with post-COVID-19 condition. Furthermore, it is unclear which measurement instruments are appropriate for use in research and clinical management of children and young people with post-COVID-19. To address these unmet needs, we conducted a consensus study, aiming to develop a core outcome set (COS) and an associated core outcome measurement set (COMS) for evaluating post-COVID-19 condition in children and young people. Our methodology comprised of two phases. In phase 1 (to create a COS), we performed an extensive literature review and categorisation of outcomes, and prioritised those outcomes in a two-round online modified Delphi process followed by a consensus meeting. In phase 2 (to create the COMS), we performed another modified Delphi consensus process to evaluate measurement instruments for previously defined core outcomes from phase 1, followed by an online consensus workshop to finalise recommendations regarding the most appropriate instruments for each core outcome. In phase 1, 214 participants from 37 countries participated, with 154 (72%) contributing to both Delphi rounds. The subsequent online consensus meeting resulted in a final COS which encompassed seven critical outcomes: fatigue; post-exertion symptoms; work/occupational and study changes; as well as functional changes, symptoms, and conditions relating to cardiovascular, neuro-cognitive, gastrointestinal and physical outcomes. In phase 2, 11 international experts were involved in a modified Delphi process, selecting measurement instruments for a subsequent online consensus workshop where 30 voting participants discussed and independently scored the selected instruments. As a result of this consensus process, four instruments met a priori consensus criteria for inclusion: PedsQL multidimensional fatigue scale for "fatigue"; PedsQL gastrointestinal symptom scales for "gastrointestinal"; PedsQL cognitive functioning scale for "neurocognitive" and EQ-5D for "physical functioning". Despite proposing outcome measurement instruments for the remaining three core outcomes ("cardiovascular", "post-exertional malaise", "work/occupational and study changes"), a consensus was not achieved. Our international, consensus-based initiative presents a robust framework for evaluating post-COVID-19 condition in children and young people in research and clinical practice via a rigorously defined COS and associated COMS. It will aid in the uniform measurement and reporting of relevant health outcomes worldwide.
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COVID-19 , Síndrome Post Agudo de COVID-19 , Adolescente , Niño , Humanos , Técnica Delphi , Evaluación de Resultado en la Atención de Salud , Proyectos de Investigación , Resultado del TratamientoRESUMEN
Understanding modifiable prenatal and early life causal determinants of food allergy is important for the prevention of the disease. Randomized clinical trials studying environmental and dietary determinants of food allergy may not always be feasible. Identifying risk/protective factors for early-life food allergy often relies on observational studies, which may be affected by confounding bias. The directed acyclic graph (DAG) is a causal diagram useful to guide causal inference from observational epidemiological research. To date, research on food allergy has made little use of this promising method. We performed a literature review of existing evidence with a systematic search, synthesized 32 known risk/protective factors, and constructed a comprehensive DAG for early-life food allergy development. We present an easy-to-use online tool for researchers to re-construct, amend, and modify the DAG along with a user's guide to minimize confounding bias. We estimated that adjustment strategies in 57% of previous observational studies on modifiable factors of childhood food allergy could be improved if the researchers determined their adjustment sets by DAG. Future researchers who are interested in the causal inference of food allergy development in early life can apply the DAG to identify covariates that should and should not be controlled in observational studies.
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Hipersensibilidad a los Alimentos , Humanos , Hipersensibilidad a los Alimentos/epidemiología , Niño , Estudios Epidemiológicos , Factores de Riesgo , CausalidadRESUMEN
BACKGROUND: IgE-mediated food allergy (FA) is a global health concern with substantial individual and societal implications. While diverse intervention strategies have been researched, inconsistencies in reported outcomes limit evaluations of FA treatments. To streamline evaluations and promote consistent reporting, the Core Outcome Measures for Food Allergy (COMFA) initiative aimed to establish a Core Outcome Set (COS) for FA clinical trials and observational studies of interventions. METHODS: The project involved a review of published clinical trials, trial protocols and qualitative literature. Outcomes found as a result of review were categorized and classified, informing a two-round online-modified Delphi process followed by hybrid consensus meeting to finalize the COS. RESULTS: The literature review, taxonomy mapping and iterative discussions with diverse COMFA group yielded an initial list of 39 outcomes. The iterative online and in-person meetings reduced the list to 13 outcomes for voting in the formal Delphi process. One more outcome was added based on participant suggestions after the first Delphi round. A total of 778 participants from 52 countries participated, with 442 participating in both Delphi rounds. No outcome met a priori criteria for inclusion, and one was excluded as a result of the Delphi. Thirteen outcomes were brought to the hybrid consensus meeting as a result of Delphi and two outcomes, 'allergic symptoms' and 'quality of life' achieved consensus for inclusion as 'core' outcomes. CONCLUSION: In addition to the mandatory reporting of adverse events for FA clinical trials or observational studies of interventions, allergic symptoms and quality of life should be measured as core outcomes. Future work by COMFA will define how best to measure these core outcomes.
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Hipersensibilidad a los Alimentos , Calidad de Vida , Humanos , Técnica Delphi , Hipersensibilidad a los Alimentos/diagnóstico , Hipersensibilidad a los Alimentos/terapia , Inmunoglobulina E , Evaluación de Resultado en la Atención de Salud , Proyectos de Investigación , Resultado del Tratamiento , Ensayos Clínicos como Asunto , Estudios Observacionales como AsuntoRESUMEN
BACKGROUND: The Hyperhidrosis Quality of Life Index (HidroQoL©) is a measure of quality of life (QoL) impacts in hyperhidrosis (HH). OBJECTIVES: We aimed to establish score banding systems for the HidroQoL total score for specific contexts representing different severity/impact categories by using the Dermatology Life Quality Index (DLQI) and the Hyperhidrosis Disease Severity Scale (HDSS) as anchors, including data from 357 patients from a phase III clinical trial. METHODS: We used the HDSS, the established DLQI score bands and two single items (items 5 and 7) of the DLQI as anchors for the creation of banding systems for the HidroQoL. These anchors were chosen via consensus among an expert group according to relevance to patient experience. Due to the distribution of the HDSS and the single DLQI item 7, receiver operating characteristic curves were computed in order to create an optimal cut-off value of the HidroQoL total score. For the DLQI banding system and the single DLQI item 5, we created a banding system for the HidroQoL based on the distribution of their different categories. RESULTS: A score of 30 and greater is proposed as the cut-off value for sweating that 'always interferes in daily activities', based on the HDSS as anchor. In terms of overall skin QoL effects, score bands of 0-6, 7-18, 19-25, 26-32 and 33-36 represent 'no effect', 'small effect', 'moderate effect', 'very large effect' and 'extremely large effect' on the patient's life, respectively. CONCLUSIONS: In this study, we propose different banding systems for four different contexts: skin-specific QoL (DLQI banding), HH severity (HDSS), working and studying (single DLQI item 7) and social and leisure activities (single DLQI item 5). These banding systems and cut-off values can be used in clinical research and practice to place the patients in different severity categories.
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Hiperhidrosis , Calidad de Vida , Humanos , Resultado del Tratamiento , Hiperhidrosis/cirugía , Sudoración , Índice de Severidad de la EnfermedadRESUMEN
BACKGROUND: The Harmonising Outcome Measures for Eczema (HOME) initiative has agreed upon the Core Outcome Set (COS) for use in atopic dermatitis (AD) clinical trials, but additional guidance is needed to maximize its uptake. OBJECTIVES: To provide answers to some of the commonly asked questions about using the HOME COS; to provide data to help with the interpretation of trial results; and to support sample size calculations for future trials. METHODS AND RESULTS: We provide practical guidance on the use of the HOME COS for investigators planning clinical trials in patients with AD. It answers some of the common questions about using the HOME COS, how to access the outcome measurement instruments, what training/resources are needed to use them appropriately and clarifies when the COS is applicable. We also provide exemplar data to inform sample size calculations for eczema trials and encourage standardized data collection and reporting of the COS. CONCLUSIONS: By encouraging adoption of the COS and facilitating consistent reporting of outcome data, it is hoped that the results of eczema trials will be more comprehensive and readily combined in meta-analyses and that patient care will subsequently be improved.
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Dermatitis Atópica , Eccema , Humanos , Dermatitis Atópica/tratamiento farmacológico , Eccema/terapia , Predicción , Evaluación de Resultado en la Atención de Salud , Índice de Severidad de la Enfermedad , Resultado del Tratamiento , Ensayos Clínicos como AsuntoRESUMEN
AIM: To analyze the association of individual pre-ICU risk factors (obesity, physical and mental comorbidity, smoking status) on the long-term recovery process in survivors of the acute respiratory distress syndrome (ARDS; outcomes: health related quality of life, health care utilization; measured at 12, 24, and 36 months after ICU discharge). FINDINGS: Results show a possible causal link between pre-ICU risk factors and subsequent recovery of survivors of ARDS, especially with regard to mental health related quality of life. PURPOSE: Identifying relevant pre-existing risk factors, such as mental health problems, will enable the identification of at-risk patients, thus aiding in the improvement of long-term healthcare for survivors of critical illness.
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Calidad de Vida , Síndrome de Dificultad Respiratoria , Sobrevivientes , Humanos , Síndrome de Dificultad Respiratoria/terapia , Síndrome de Dificultad Respiratoria/psicología , Calidad de Vida/psicología , Masculino , Femenino , Persona de Mediana Edad , Factores de Riesgo , Sobrevivientes/psicología , Sobrevivientes/estadística & datos numéricos , Estudios de Cohortes , Anciano , Aceptación de la Atención de Salud/estadística & datos numéricos , Aceptación de la Atención de Salud/psicología , Adulto , Unidades de Cuidados Intensivos/organización & administración , Unidades de Cuidados Intensivos/estadística & datos numéricosRESUMEN
PURPOSE: To conduct a systematic review of the quality of patient-reported outcome measures (PROMs) for primary dysmenorrhea (PDys) using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology, and to derive recommendations for use of the PROMs. METHODS: We searched PubMed and Web of Science for studies reporting on the development and/or validation of any PROMs for women with PDys. Applying the COSMIN Risk of Bias Checklist, we assessed the methodological quality of each included study. We further evaluated the quality of measurement properties per PROM and study according to the criteria for good measurement properties, and graded the evidence. Based on the overall evidence, we derived recommendations for the use of the included PROMs. RESULTS: Data from seven studies reporting on four PROMs addressing different outcomes were included. Among those, the Adolescent Dysmenorrhic Self-Care Scale (ADSCS) and the on-menses version of the Dysmenorrhea Symptom Interference Scale (DSI) can be recommended for use. The Exercise of Self-Care Agency Scale (ESCAS) and the Dysmenorrhea Daily Diary (DysDD) have the potential to be recommended for use, but require further validation. The off-menses version of the DSI cannot be recommended for use. CONCLUSIONS: The ADSCS can be recommended for the assessment of self-care behavior in PDys. Regarding measures of impact, the on-menses version of the DSI is a suitable tool. Covering the broadest spectrum of outcomes, the DysDD is promising for use in medical care and research, encouraging further investigations. Further validation studies are indicated for all included PROMs.
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Dismenorrea , Calidad de Vida , Adolescente , Humanos , Femenino , Calidad de Vida/psicología , Encuestas y Cuestionarios , Dismenorrea/terapia , Medición de Resultados Informados por el Paciente , Psicometría/métodosRESUMEN
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.
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Dermatitis Atópica , Calidad de Vida , Índice de Severidad de la Enfermedad , Humanos , Adulto , Femenino , Masculino , Persona de Mediana Edad , Singapur/epidemiología , Dermatitis Atópica/diagnóstico , Anciano , Adolescente , Adulto Joven , Anciano de 80 o más Años , Reproducibilidad de los Resultados , Medición de Resultados Informados por el Paciente , Valor Predictivo de las Pruebas , AutoinformeRESUMEN
BACKGROUND: Despite the significant role of scientific knowledge pertaining to public health, the discipline of public health remained outside the centre stage within the pandemic discourse. Against this background, we investigated the role of German public health academics during the pandemic in our study, focusing on their orientations and associated values. METHODS: We interviewed 21 public health scholars from Germany and collected 36 documents published by public health scientific societies. We analyzed data by grounded theory and situational mapping. RESULTS: We identified five types of self-images identified among healthcare academics: the scientific study supplier, the expert facing political issues, the restrained scholar, the public informer and the changemaker. The typology yields insights into the multiple dimensions of public health and its role in times of crisis. CONCLUSIONS: The findings provide implications to inter- and transdisciplinary interaction and to managing the expectations of public health professionals in relation to crisis management.
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COVID-19 , Salud Pública , Investigación Cualitativa , Humanos , COVID-19/epidemiología , Alemania , Pandemias , Masculino , SARS-CoV-2 , FemeninoRESUMEN
Vitiligo is a common disorder characterized by the visible loss of skin pigmentation. Non-segmental vitiligo (NSV) is the major subtype. The disease is caused by autoimmune-mediated destruction of melanocytes. Vitiligo leads to stigmatization and a significant reduction in quality of life. Disregarding the psychosocial burden, vitiligo is sometimes viewed solely as a cosmetic problem and, according to a global survey, is diagnosed on average only after 2.4 years. This delay contributes to a considerable burden of disease, including suicidal ideation. Stigmatization promotes the development of psychological comorbidities such as anxiety and depressive disorders, with prevalence rates varying by country and study (0.1%-67.9%). Data for Germany are heterogeneous and largely based on estimates. Due to psychosocial factors, the inflammatory component, and a higher incidence of somatic comorbidities, NSV may be regarded as an inflammatory systemic disease. We recommend optimizing care by incorporating the assessment of quality of life as a standard in routine care, in addition to monitoring disease activity. Moreover, early screening for psychological comorbidities is crucial to initiate appropriate treatment before the condition becomes chronic and cumulative (irreversible) impairments occur. The goal is a personalized and patient-centered integrated care approach that sustainably improves the health status of those affected.
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OBJECTIVE: The role of allergy as a risk factor for Long-COVID (LC) is unclear and has not been thoroughly examined yet. We aimed to systematically review and appraise the epidemiological evidence on allergic diseases as risk factors for LC. DESIGN: This is an initial systematic review. Two reviewers independently performed the study selection and data extraction using Covidence. Risk of bias (RoB) and certainty of evidence (GRADE) were assessed. Random effects meta-analyses were used to pool unadjusted ORs within homogeneous data subsets. DATA SOURCES: We retrieved articles published between January 1st, 2020 and January 19th, 2023 from MEDLINE via PubMed, Scopus, the WHO-COVID-19 database and the LOVE platform (Epistemonikos Foundation). In addition, citations and reference lists were searched. ELIGIBILITY CRITERIA: We included prospective cohort studies recruiting individuals of all ages with confirmed SARS-CoV-2 infection that were followed up for at least 12 months for LC symptoms where information on pre-existing allergic diseases was available. We excluded all study designs that were not prospective cohort studies and all publication types that were not original articles. RESULTS: We identified 13 studies (9967 participants, range 39-1950 per study), all assessed as high RoB, due to population selection and methods used to ascertain the exposures and the outcome. Four studies did not provide sufficient data to calculate Odds Ratios. The evidence supported a possible relationship between LC and allergy, but was very uncertain. For example, pre-existing asthma measured in hospital-based populations (6 studies, 4019 participants) may be associated with increased risk of LC (Odds Ratio 1.94, 95% CI 1.08, 3.50) and findings were similar for pre-existing rhinitis (3 studies, 1141 participants; Odds Ratio 1.96, 95% CI 1.61, 2.39), both very low certainty evidence. CONCLUSIONS: Pre-existing asthma or rhinitis may increase the risk of LC.
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Asma , COVID-19 , Rinitis , Humanos , COVID-19/epidemiología , Síndrome Post Agudo de COVID-19 , SARS-CoV-2 , Estudios Prospectivos , Asma/epidemiología , Asma/etiología , Factores de RiesgoRESUMEN
OBJECTIVE: To summarise and critically appraise systematic review (SR) evidence on the effects of timing of complementary feeding (CF) on the occurrence of allergic sensitisation and disease. DESIGN: Overview of SRs. AMSTAR-2 and ROBIS were used to assess methodological quality and risk of bias (RoB) of SRs. RoB 2 Tool was used to assess RoB of primary randomised controlled trials (RCTs) (or extracted). The certainty of evidence (CoE) was assessed using GRADE. Findings were synthesised narratively. DATA SOURCES: MEDLINE (via PubMed and Ovid), the Cochrane Library and Web of Science Core Collection (2010 to 27 February 2023). ELIGIBILITY CRITERIA: SRs investigating the effects of timing of CF in infants or young children (0-3 years) on risk of developing food allergy (FA), allergic sensitisation, asthma, allergic rhinitis, atopic eczema and adverse events based on RCT evidence. RESULTS: Eleven SRs were included. Only two SRs had low RoB; common issues were failure to report on funding of primary studies and failure to provide a list of excluded trials. Common limitations of included trials were lack of blinding of outcome assessment or detailed trial preregistration, and inadequate handling of high loss to follow up. Primary study overlap was very high for specific FA and slight to moderate for FA in general and other primary outcomes. Introducing specific foods (peanut, cooked egg) early probably reduces the risk of specific FA. Evidence for other allergic outcomes was mostly very uncertain and based on few primary studies. Trials varied regarding timing of CF, nature of complementary foods and population risk, which limited comparability between SRs. CONCLUSIONS: For developing guidelines to support decision-making on the timing of CF as a preventive strategy, early introduction of specific foods (i.e. egg and peanut) seems promising and safe, whereas more extensive research is required regarding other allergic outcomes and potential adverse events.
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Asma , Dermatitis Atópica , Hipersensibilidad a los Alimentos , Lactante , Niño , Preescolar , Humanos , Revisiones Sistemáticas como Asunto , Hipersensibilidad a los Alimentos/prevención & control , Fenómenos Fisiológicos Nutricionales del LactanteRESUMEN
BACKGROUND: Core outcome sets (COS) are consensus-driven sets of minimum outcomes that should be measured and reported in all clinical trials. COS aim to reduce heterogeneity in outcome measurement and reporting, and selective outcome reporting. Implementing COS into clinical trials is challenging. Guidance to improve COS uptake in dermatology is lacking. OBJECTIVES: To develop a structured practical guide to COS implementation. METHODS: Members of the Harmonising Outcome Measurement for Eczema (HOME) executive committee developed an expert opinion-based roadmap founded on a combination of a review of the COS implementation literature, the Core Outcome Measures in Effectiveness Trials (COMET) initiative resources, input from HOME members and experience in COS development and clinical trials. RESULTS: The data review and input from HOME members was synthesized into themes, which guided roadmap development: (a) barriers and facilitators to COS uptake based on stakeholder awareness/engagement and COS features; and (b) key implementation science principles (assessment-driven, data-centred, priority-based and context-sensitive). The HOME implementation roadmap follows three stages. Firstly, the COS uptake scope and goals need to be defined. Secondly, during COS development, preparation for future implementation is supported by establishing the COS as a credible evidence-informed consensus by applying robust COS development methodology, engaging multiple stakeholders, fostering sustained and global engagement, emphasizing COS ease of use and universal applicability, and providing recommendations on COS use. Thirdly, incorporating completed COS into primary (trials) and secondary (reviews) research is an iterative process starting with mapping COS uptake and stakeholders' attitudes, followed by designing and carrying out targeted implementation projects. Main themes for implementation projects identified at HOME are stakeholder awareness/engagement; universal applicability for different populations; and improving ease-of-use by reducing administrative and study burden. Formal implementation frameworks can be used to identify implementation barriers/facilitators and to design implementation strategies. The effect of these strategies on uptake should be evaluated and implementation plans adjusted accordingly. CONCLUSIONS: COS can improve the quality and applicability of research and, so, clinical practice but can only succeed if used and reported consistently. The HOME implementation roadmap is an extension of the original HOME roadmap for COS development and provides a pragmatic framework to develop COS implementation strategies.
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Eccema , Humanos , Eccema/terapia , Evaluación de Resultado en la Atención de Salud , Consenso , Predicción , Participación de los Interesados , Resultado del Tratamiento , Proyectos de Investigación , Técnica DelphiRESUMEN
A systematic review on measurement properties of patient-reported outcome measures (PROMs) for the assessment of quality of life (QoL) in children and adults with eczema was published in 2016 and updated in 2019. We now aimed to systematically assess the measurement properties of PROMs based on recently published development and validation studies regarding quality-of-life skin- or disease-specific PROMs using the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines and integrate these findings with those from the 2019 update. A systematic literature search was conducted in PubMed and Embase. Eligible studies reported on measurement properties of QoL skin- or disease-specific PROMs for the assessment of QoL in children and adults with eczema. The methodological quality of the included studies was evaluated using the COSMIN Risk of Bias checklist. The methodological quality of the included PROMs was judged using updated criteria for good measurement properties, and the quality of evidence was graded. The new evidence was integrated into the results from the 2019 update. Finally, a recommendation for use of the identified PROMs was derived based on all evidence. We identified 12 studies fulfilling our inclusion criteria. Based on the newly generated evidence, the Childhood Atopic Dermatitis Impact Scale-short form (CADIS-SF) for infants and the Skindex for adults can be recommended for use. We identified three new PROMs, which have the potential to be used, but require further validation: the Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ), the Skindex-Mini, and the Scratch Intensity and Impact Scale (SIIS). All other assessed PROMs still have the opportunity to be recommended for use (except for the Dermatology Life Quality Index (DLQI)) but need further validation. Currently, two PROMs for the assessment of QoL in eczema can be recommended for use: the CADIS-SF for infants and the Skindex for adults. Many PROMs, including the recently developed and/or validated PROMs PADQLQ, Skindex-Mini and SIIS, need further validation.
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Dermatitis Atópica , Eccema , Lactante , Humanos , Niño , Adulto , Calidad de Vida , Eccema/terapia , Encuestas y Cuestionarios , Evaluación de Resultado en la Atención de SaludRESUMEN
BACKGROUND: Only rigorously prepared analyses can provide the highest level of evidence to inform decision-making. Several recent systematic reviews (SRs) examined the hypothesis that the early introduction of specific allergenic complementary foods (CFs) to infants may lead to a lower incidence of one or more allergic outcomes. However, the methodological rigour and quality of reporting of SRs in this area has not yet been systematically evaluated. METHODS: We comprehensively searched PubMed, Medline (Ovid), and Web of Science Core Collection on 13th January 2022, using a pre-specified and tested search syntax for SRs with RCT evidence on the early introduction of allergenic CFs as a means for allergy prevention in infants and children. We examined the quality and risk of bias (RoB) using AMSTAR-2 and ROBIS tools, examined adherence to the Preferred Reporting Items for SRs and Meta-Analyses (PRISMA), and checked whether certainty of the evidence was assessed. RESULTS: Twelve SRs were included. Application of both tools resulted in similar overall judgements in terms of direction and extent for nine of the 12 SRs. Nine SRs were found to be of critically low to low quality according to AMSTAR-2 and to be at high RoB according to ROBIS. One SR received a moderate quality rating (AMSTAR-2) and high RoB rating (ROBIS). However, for two SRs, judgements between AMSTAR-2 and ROBIS were at stark variance. Only two SRs fully adhered to the PRISMA checklist. Six SRs evaluated the certainty of the body of RCT evidence. Several SRs failed to consider unpublished studies either by an explicit a priori exclusion or by inadequate search strategies. CONCLUSIONS: Well-conducted SRs are important for decision-making and informing guideline development, the quality of their methodology should therefore be considered. The methodological rigour and the reporting quality of SRs on the timing of CF for allergy prevention must be improved. REGISTRATION: https://osf.io/7cs4b .
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Hipersensibilidad , Proyectos de Investigación , Niño , Preescolar , Humanos , Lactante , Sesgo , Lista de Verificación , Hipersensibilidad/prevención & control , Fenómenos Fisiológicos Nutricionales del Lactante , Revisiones Sistemáticas como AsuntoRESUMEN
PURPOSE: We aimed to assess symptoms in patients after SARS-CoV-2 infection and to identify factors predicting prolonged time to symptom-free. METHODS: COVIDOM/NAPKON-POP is a population-based prospective cohort of adults whose first on-site visits were scheduled ≥ 6 months after a positive SARS-CoV-2 PCR test. Retrospective data including self-reported symptoms and time to symptom-free were collected during the survey before a site visit. In the survival analyses, being symptom-free served as the event and time to be symptom-free as the time variable. Data were visualized with Kaplan-Meier curves, differences were tested with log-rank tests. A stratified Cox proportional hazard model was used to estimate adjusted hazard ratios (aHRs) of predictors, with aHR < 1 indicating a longer time to symptom-free. RESULTS: Of 1175 symptomatic participants included in the present analysis, 636 (54.1%) reported persistent symptoms after 280 days (SD 68) post infection. 25% of participants were free from symptoms after 18 days [quartiles: 14, 21]. Factors associated with prolonged time to symptom-free were age 49-59 years compared to < 49 years (aHR 0.70, 95% CI 0.56-0.87), female sex (aHR 0.78, 95% CI 0.65-0.93), lower educational level (aHR 0.77, 95% CI 0.64-0.93), living with a partner (aHR 0.81, 95% CI 0.66-0.99), low resilience (aHR 0.65, 95% CI 0.47-0.90), steroid treatment (aHR 0.22, 95% CI 0.05-0.90) and no medication (aHR 0.74, 95% CI 0.62-0.89) during acute infection. CONCLUSION: In the studied population, COVID-19 symptoms had resolved in one-quarter of participants within 18 days, and in 34.5% within 28 days. Over half of the participants reported COVID-19-related symptoms 9 months after infection. Symptom persistence was predominantly determined by participant's characteristics that are difficult to modify.
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COVID-19 , Adulto , Humanos , Femenino , Persona de Mediana Edad , COVID-19/diagnóstico , COVID-19/epidemiología , SARS-CoV-2 , Estudios Prospectivos , Estudios Retrospectivos , Factores de RiesgoRESUMEN
PURPOSE: To conduct a systematic review of the quality of existing patient-reported outcome measures (PROMs) for use in women with uncomplicated urinary tract infections (UTIs) applying the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology, and to derive recommendations for their use in future research. METHODS: A systematic literature search was performed in PubMed and Web of Science. Studies reporting on the development and/or validation of any PROMs for uncomplicated UTIs in women were considered eligible. We evaluated the methodological quality of each included study using the COSMIN Risk of Bias Checklist, and further applied predefined criteria for good measurement properties. Finally, we graded the evidence and derived recommendations for the use of the included PROMs. RESULTS: Data from 23 studies reporting on six PROMs were included. From those, the Acute Cystitis Symptom Score (ACSS) and the Urinary Tract Infection-Symptom and Impairment Questionnaire (UTI-SIQ-8) can be recommended for further use. Both instruments showed sufficient content validity. We further found high-quality evidence for sufficient internal consistency of the UTI-SIQ-8, while this criterion was not assessed for the ACSS due to a formative measurement model. All other PROMs have the potential to be recommended for use, but require further validation. CONCLUSION: The ACSS and the UTI-SIQ-8 have the potential to be recommended for use in women with uncomplicated UTIs in future clinical trials. For all included PROMs, further validation studies are indicated. SYSTEMATIC REVIEW REGISTRATION: PROSPERO.
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Calidad de Vida , Infecciones Urinarias , Humanos , Femenino , Calidad de Vida/psicología , Medición de Resultados Informados por el Paciente , Lista de Verificación/métodos , Encuestas y CuestionariosRESUMEN
Self-assessment of general health status has a significant influence on patient-related outcomes. The aims of this study were to investigate and compare the level of agreement between patients' and dermatologists' assessments of the severity of chronic hand eczema. From the German registry "German Chronic Hand Eczema Patient Long-Term Management Registry" (CARPE), 1,281 pairs of patients with chronic hand eczema and their dermatologists were included. Of these, 788 pairs served as a comparison 2 years after baseline. Concordance analyses found that complete concordance between patients' and dermatologists' assessments were 16.62% at baseline and 11.47% at follow-up. Overall, patients assessed their chronic eczema at baseline as more severe than did the dermatologists; whereas, at follow-up, patients assessed their condition as less severe than the dermatologists' assessment. Bangdiwala's B showed lower values of concordance for womens' and older patients' self-assessment with the dermatologists' assessments. In conclusion, dermatologists should consider the patient's perspective and the individual's assessment of their chronic hand eczema in order to provide effective care in clinical practice.
Asunto(s)
Eccema , Dermatosis de la Mano , Médicos , Femenino , Humanos , Autoinforme , Dermatosis de la Mano/diagnóstico , Dermatosis de la Mano/epidemiología , Eccema/diagnóstico , Eccema/epidemiología , Sistema de Registros , Índice de Severidad de la EnfermedadRESUMEN
TREATgermany is an investigator-initiated prospective disease registry. It investigates physician- and patient-reported disease severity (Eczema Area and Severity Index (EASI), objective Scoring Atopic Dermatitis (oSCORAD), Investigator Global Assessment, Patient-Oriented Eczema Measure (POEM), Patient Global Assessment (PGA)), patient-reported symptoms (itch, sleep loss, depressive symptoms), therapy courses and dermatological quality of life (DLQI) in moderate-to-severe atopic dermatitis with SCORAD > 20. 1,134 atopic dermatitis patients (mean age 41.0 ± 14.7 years, 42.5% females) were enrolled by 40 German recruiting sites (dermatological clinics and practices) between June 2016 and April 2021. The current analysis focuses on itch scores obtained with a numerical rating scale (NRS)) documented for the previous 3 days prior to baseline visit. The results show that 97.2% (1,090 of 1,121) patients experienced itch. Itch severity correlated moderately with severity of atopic dermatitis oSCORAD (rho = 0.44 (0.39-0.48)) and EASI score (rho = 0.41 (0.36-0.46)). A strong correlation was found with self-reported disease severity as PGA (rho = 0.68 (0.65-0.71)), POEM sum score (rho = 0.66 (0.63-0.69)) and dermatological quality of life impairment DLQI (rho = 0.61 (0.57-0.65)). Itch as a subjective complaint is more closely correlated with patient-reported outcomes than with objective assessments by the physician.
Asunto(s)
Dermatitis Atópica , Eccema , Médicos , Femenino , Humanos , Adulto , Persona de Mediana Edad , Masculino , Dermatitis Atópica/diagnóstico , Calidad de Vida , Estudios Prospectivos , Índice de Severidad de la Enfermedad , Prurito , Medición de Resultados Informados por el Paciente , Sistema de RegistrosRESUMEN
BACKGROUND: Sunburn can increase one's risk of developing skin cancer. We aimed to quantify the prevalence of sunburn during recreational outdoor sport (ROS) in summer, to explore the use of different sun protection measures, and to examine factors associated with sunburn during ROS using a population-based sample from Germany. METHODS: For this cross-sectional study, 2081 individuals aged 16-65 years who reported being engaged in ROS in summer were surveyed via standardized telephone interviews in 2020 (National Cancer Aid Monitoring, NCAM). RESULTS: Overall, 16.7% reported experiencing at least one sunburn during ROS in the past twelve months. Sunburn occurrence was negatively associated with the age of the participants (e.g. OR = 0.49 in 56-65 year-olds, p < .001), and positively associated with skin type I/II (OR = 1.55, p < .001) and with having a higher number of nevi (OR = 1.42, p = .005). While wearing sleeved shirts was the most frequently-used sun protection measure during ROS (74.9%), wearing headgear was least common in our sample (29.0%). In multivariate analyses, sunburn was positively associated with the use of sun protection measures (e.g. OR = 1.32 for wearing sleeved shirts, p = .02). CONCLUSIONS: Our nationwide data show that ROS is one of the settings where sun protection should play a greater role. Especially in organized sports, particular attention should be devoted to organizational (e.g. exercise outside peak hours) or contextual measures (e.g. shade by the natural or built environment) to prevent skin cancer in later life.