36 results on '"Spuls, P. I."'
Search Results
2. A core outcome domain set for clinical research on capillary malformations (the COSCAM project): an e‐Delphi process and consensus meeting*
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Langbroek, Ginger Beau, Wolkerstorfer, Albert, Horbach, Sophie ER, Spuls, Phyllis I, Kelly, Kristen M, Robertson, Susan J, Raath, M Ingmar, Al‐Niaimi, Firas, Kono, Taro, Boixeda, Pablo, Laubach, Hans J, Badawi, Ashraf M, Rubin, Agneta Troilius, Haedersdal, Merete, Manuskiatti, Woraphong, Horst, Chantal MAM, Ubbink, DT, and group, COSCAM study
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Biomedical and Clinical Sciences ,Clinical Sciences ,Clinical Research ,Clinical Trials and Supportive Activities ,Humans ,Consensus ,Delphi Technique ,Glaucoma ,Outcome Assessment ,Health Care ,Quality of Life ,Research Design ,Treatment Outcome ,Clinical Trials as Topic ,COSCAM study group ,Oncology and Carcinogenesis ,Dermatology & Venereal Diseases ,Clinical sciences - Abstract
BackgroundThere is limited evidence on the best available treatment options for capillary malformations (CMs), mainly due to the absence of uniform outcome measures in trials on therapies. A core outcome set (COS) enables standard reporting of trial outcomes, which facilitates comparison of treatment results.ObjectivesTo develop a core outcome domain set (CDS), as part of a core outcome set (COS), for clinical research on CMs.MethodsSixty-seven potentially relevant outcome subdomains were recognized based on the literature, focus group sessions, and input from the COSCAM working group. These outcome subdomains were presented in an online Delphi study to CM experts (medical specialists and authors of relevant literature) and (parents of) patients with CM (international patient associations). During three e-Delphi study rounds, the participants repeatedly scored the importance of these outcome subdomains on a seven-point Likert scale. Participants could also propose other relevant outcome subdomains. Consensus was defined as ≥ 80% agreement as to the importance of an outcome subdomain among both stakeholder groups. The CDS was finalized during an online consensus meeting.ResultsIn total 269 participants from 45 countries participated in the first e-Delphi study round. Of these, 106 were CM experts from 32 countries, made up predominantly of dermatologists (59%) and plastic surgeons (18%). Moreover, 163 (parents of) patients with CM from 28 countries participated, of whom 58% had Sturge-Weber syndrome. During the two subsequent e-Delphi study rounds, 189 and 148 participants participated, respectively. After the entire consensus process, consensus was reached on 11 outcome subdomains: colour/redness, thickness, noticeability, distortion of anatomical structures, glaucoma, overall health-related quality of life, emotional functioning, social functioning, tolerability of intervention, patient satisfaction with treatment results, and recurrence.ConclusionsWe recommend the CDS to be used as a minimum reporting standard in all future trials of CM therapy. Our next step will be to select suitable outcome measurement instruments to score the core outcome subdomains. What is already known about this topic? Besides physical and functional sequelae, capillary malformations (CMs) often cause emotional and social burden. The lack of uniform outcome measures obstructs proper evaluation and comparison of treatment strategies. As a result, there is limited evidence on the best available treatment options. The development of a core outcome set (COS) may improve standardized reporting of trial outcomes. What does this study add? A core outcome domain set (CDS), as part of a COS, was developed for clinical research on CMs. International consensus was reached on the recommended core outcome subdomains to be measured in CM trials: colour/redness, thickness, noticeability, distortion of anatomical structures, glaucoma, overall health-related quality of life, emotional functioning, social functioning, tolerability of intervention, patient satisfaction with treatment results, and recurrence. This CDS enables the next step in the development of a COS, namely to reach consensus on the core outcome measurement instruments to score the core outcome subdomains. What are the clinical implications of this work? The obtained CDS will facilitate standardized reporting of treatment outcomes, thereby enabling proper comparison of treatment results. This comparison is likely to provide more reliable information for patients about the best available treatment options.
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- 2022
3. Clinical relevance and uptake of core outcome sets in dermatology
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Ahmed, Areeba, Koza, Eric, Shi, Victoria, Ma, Melissa, Haq, Misha, Kottner, Jan, Garg, Amit, Ingram, John R., Ezzedine, Khaled, Spuls, Phyllis I., Beeckman, Dimitri, Wolkenstein, Pierre, Fransen, Frederike, Noe, Megan H., Langbroek, Ginger Beau, Bauer, Andrea, Thorlacius, Linnea, Horbach, Sophie E. R., Layton, Alison, Apfelbacher, Christian, Cahn, Brian A., Pearlman, Ross, Schlessinger, Daniel I., and Alam, Murad
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- 2024
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4. Implementation of the HOME core outcome set for clinical trials of atopic eczema—barriers and opportunities: the HOME IX meeting report
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Jacobson, M. E., Thomas, K. S., Apfelbacher, C. J., Leshem, Y. A., Williams, H. C., Gerbens, L. A. A., Spuls, P. I., Schmitt, J., Howells, L., Katoh, N., and Simpson, E. L.
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- 2023
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5. Primary SARS-CoV-2 infection in patients with immune-mediated inflammatory diseases: long-term humoral immune responses and effects on disease activity
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van Dam, Koos P. J., Volkers, Adriaan G., Wieske, Luuk, Stalman, Eileen W., Kummer, Laura Y. L., van Kempen, Zoé L. E., Killestein, Joep, Tas, Sander W., Boekel, Laura, Wolbink, Gerrit J., van der Kooi, Anneke J., Raaphorst, Joost, Takkenberg, R. Bart, D’Haens, Geert R. A. M., Spuls, Phyllis I., Bekkenk, Marcel W., Musters, Annelie H., Post, Nicoline F., Bosma, Angela L., Hilhorst, Marc L., Vegting, Yosta, Bemelman, Frederike J., Voskuyl, Alexandre E., Broens, Bo, Sanchez, Agner Parra, van Els, Cécile A. C. M., de Wit, Jelle, Rutgers, Abraham, de Leeuw, Karina, Horváth, Barbara, Verschuuren, Jan J. G. M., Ruiter, Annabel M., van Ouwerkerk, Lotte, van der Woude, Diane, Allaart, Renée C. F., Teng, Y. K. Onno, van Paassen, Pieter, Busch, Matthias H., Jallah, Papay B. P., Brusse, Esther, van Doorn, Pieter A., Baars, Adája E., Hijnen, Dirk Jan, Schreurs, Corine R. G., van der Pol, W. Ludo, Goedee, H. Stephan, Steenhuis, Maurice, Keijzer, Sofie, Keijser, Jim B. D., Cristianawati, Olvi, ten Brinke, Anja, Verstegen, Niels J. M., van Ham, S. Marieke, Rispens, Theo, Kuijpers, Taco W., Löwenberg, Mark, and Eftimov, Filip
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- 2023
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6. Risk factors associated with short-term adverse events after SARS-CoV-2 vaccination in patients with immune-mediated inflammatory diseases
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Wieske, Luuk, Kummer, Laura Y. L., van Dam, Koos P. J., Stalman, Eileen W., van der Kooi, Anneke J., Raaphorst, Joost, Löwenberg, Mark, Takkenberg, R. Bart, Volkers, Adriaan G., D’Haens, Geert R. A. M., Tas, Sander W., Spuls, Phyllis I., Bekkenk, Marcel W., Musters, Annelie H., Post, Nicoline F., Bosma, Angela L., Hilhorst, Marc L., Vegting, Yosta, Bemelman, Frederike J., Killestein, Joep, van Kempen, Zoé L. E., Voskuyl, Alexandre E., Broens, Bo, Sanchez, Agner Parra, Wolbink, Gertjan, Boekel, Laura, Rutgers, Abraham, de Leeuw, Karina, Horváth, Barbara, Verschuuren, Jan J. G. M., Ruiter, Annabel M., van Ouwerkerk, Lotte, van der Woude, Diane, Allaart, Cornelia F., Teng, Y. K. Onno, van Paassen, Pieter, Busch, Matthias H., Jallah, B. Papay, Brusse, Esther, van Doorn, Pieter A., Baars, Adája E., Hijnen, Dirkjan, Schreurs, Corine R. G., van der Pol, W. Ludo, Goedee, H. Stephan, Steenhuis, Maurice, Rispens, Theo, ten Brinke, Anja, Verstegen, Niels J. M., Zwinderman, Koos A. H., van Ham, S. Marieke, Kuijpers, Taco W., and Eftimov, Filip
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- 2022
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7. Neurological signs, symptoms and MRI abnormalities in patients with congenital melanocytic naevi and evaluation of routine MRI-screening: systematic review and meta-analysis
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Fledderus, Anne C., Widdershoven, Anna Linn, Lapid, Oren, Breugem, Corstiaan C., Pasmans, Suzanne G. M. A., van der Horst, Chantal M. A. M., Engelen, Marc M., and Spuls, Phyllis I.
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- 2022
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8. Real-world reported adverse events related to systemic immunomodulating therapy in patients with atopic dermatitis: Results from the TREAT NL (TREatment of ATopic eczema, the Netherlands) registry
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MS Dermatologie/Allergologie, Infection & Immunity, Musters, A H, van Lookeren, F L, van der Gang, L F, Middelkamp-Hup, M A, Bosma, A L, Jessurun, N T, Lapeere, H, Nguyen, A L, Ouwerkerk, W, de Schepper, S, Gerbens, L A A, Spuls, P I, MS Dermatologie/Allergologie, Infection & Immunity, Musters, A H, van Lookeren, F L, van der Gang, L F, Middelkamp-Hup, M A, Bosma, A L, Jessurun, N T, Lapeere, H, Nguyen, A L, Ouwerkerk, W, de Schepper, S, Gerbens, L A A, and Spuls, P I
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- 2024
9. Systemic Immunomodulatory Treatments for Atopic Dermatitis: Living Systematic Review and Network Meta-Analysis Update
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Drucker, Aaron M., Lam, Megan, Prieto-Merino, David, Malek, Rayka, Ellis, Alexandra G., Yiu, Zenas Z. N., Rochwerg, Bram, Di Giorgio, Sonya, Arents, Bernd W. M., Mohan, Tanya, Burton, Tim, Spuls, Phyllis I., Schmitt, Jochen, and Flohr, Carsten
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IMPORTANCE: There are multiple approved systemic treatments for atopic dermatitis. Lebrikizumab is a newly licensed biologic medication that has been compared to placebo in clinical trials but not to other systemic treatments. OBJECTIVE: To compare reported measures of efficacy and safety of lebrikizumab to other systemic treatments for atopic dermatitis in a living systematic review and network meta-analysis. DATA SOURCES: The Cochrane Central Register of Controlled Trials, MEDLINE, Embase, the Latin American and Caribbean Health Science Information database, the Global Resource of Eczema Trials database, and trial registries were searched from inception through November 3, 2023. STUDY SELECTION: Randomized clinical trials evaluating 8 or more weeks of treatment with systemic immunomodulatory medications for moderate to severe atopic dermatitis. Titles, abstracts, and full texts were screened in duplicate. DATA EXTRACTION AND SYNTHESIS: Data were abstracted in duplicate and random-effects bayesian network meta-analyses were performed. Minimal important differences were used to define important differences between medications. Certainty of evidence was assessed using the GRADE approach (Grading of Recommendations Assessment, Development and Evaluation). The updated analysis was completed from December 13, 2023, to February 20, 2024. MAIN OUTCOME MEASURES: Efficacy outcomes were the Eczema Area and Severity Index (EASI), the Patient Oriented Eczema Measure (POEM) Dermatology Life Quality Index (DLQI), and Peak Pruritus Numeric Rating Scales (PP-NRS) and were compared using mean difference (MD) with 95% credible intervals (CrI). Safety outcomes were serious adverse events and withdrawal due to adverse events. Other outcomes included the proportion of participants with 50%, 75%, and 90% improvement in EASI (EASI-50, -75, -90) and the proportion with success on the Investigator Global Assessment compared using odds ratios with 95% CrI. RESULTS: The study sample included 97 eligible trials, with a total of 24 679 patients. Lebrikizumab was associated with no important difference in change in EASI (MD, −2.0; 95% CrI, −4.5 to 0.3; moderate certainty), POEM (MD, −1.1; 95% CrI −2.5 to 0.2; moderate certainty), DLQI (MD, −0.2; 95% CrI −2.1 to 1.6; moderate certainty), or PP-NRS (MD, 0.1; 95% CrI −0.4, 0.6; high certainty) compared to dupilumab among adults with atopic dermatitis who were treated for up to 16 weeks. Dupilumab was associated with higher odds of efficacy in binary outcomes compared with lebrikizumab. The relative efficacy of other approved systemic medications was similar to that found by previous updates of this living study, with high-dose upadacitinib and abrocitinib demonstrating numerically highest relative efficacy. For safety outcomes, low event rates limited useful comparisons. CONCLUSIONS AND RELEVANCE: In this living systematic review and network meta-analysis, lebrikizumab was similarly effective to dupilumab for the short-term treatment of atopic dermatitis in adults. Clinicians and patients can use these comparative data to inform treatment decisions.
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- 2024
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10. Measuring Signs of Atopic Dermatitis in Clinical Practice: A HOME-CP Consensus Statement
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Jacobson, Michael E., Leshem, Yael A., Apfelbacher, Christian, Spuls, Phyllis I., Gerbens, Louise A. A., Thomas, Kim S., Williams, Hywel C., Katoh, Norito, Howells, Laura, Schmitt, Jochen, Deckert, Stefanie, Seshadri, Rishi, and Simpson, Eric L.
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IMPORTANCE: Outcome measurement is an essential component of value-based health care and can aid patient care, quality improvement, and clinical effectiveness evidence generation. The Harmonising Outcome Measures for Eczema Clinical Practice initiative aims to identify a list of validated, feasible, outcome measurement instruments recommended to measure atopic dermatitis (AD) in the clinical practice setting. The clinical practice set is a list of instruments that clinicians can pick and choose from to suit their needs in the context of clinical care. OBJECTIVE: To recommend instruments to measure clinical signs of AD in clinical practice. EVIDENCE REVIEW: Following the predefined roadmap, a mixed methods design was implemented and incorporated systematic reviews and qualitative consensus methods. Previous systematic reviews identified few clinical signs instruments with sufficient validation for recommendation. An updated systematic review evaluating the validity of clinical signs instruments informed an international meeting to reach consensus on recommended instruments to measure AD clinical signs in clinical practice. Consensus was defined as less than 30% disagreement. An in-person consensus exercise was held in Montreal, Canada, on October 16, 2022. The 34 attendees included patient and patient advocate research partners, health care professionals, researchers, methodologists, and industry representatives. FINDINGS: The updated systematic review found that the Eczema Area and Severity Index (EASI), Scoring Atopic Dermatitis, and objective Scoring Atopic Dermatitis were the only instruments that demonstrated sufficient performance in all assessed measurement properties. The modified EASI and Signs Global Assessment × Body Surface Area instruments were also recommended. The EASI, Validated Investigator Global Assessment, and Investigator’s Global Assessment multiplied by or measured concurrently with a body surface area measure achieved consensus in criteria and were adopted. CONCLUSIONS AND RELEVANCE: This consensus statement by the Harmonising Outcome Measures for Eczema initiative suggests that when assessing and documenting clinical signs of AD, there are several valid and feasible instruments that can best fit a clinician’s specific practice needs. These instruments should improve and standardize the documentation of signs severity, help determine the effect of treatment, facilitate the generation of clinical effectiveness evidence, and enhance the implementation of value-based health care.
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- 2024
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11. Phototherapy for atopic dermatitis: A survey of European practice
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Steyn, M., primary, Gerbens, L. A. A., additional, Spuls, P. I., additional, Mashayekhi, S., additional, Deleuran, M., additional, Barbarot, S., additional, Wollenberg, A., additional, Ferguson, J., additional, Ibbotson, S., additional, and Flohr, C., additional
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- 2023
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12. Expanding the molecular and clinical spectrum of autosomal recessive congenital ichthyosis caused by pathogenic variants in NIPAL4 and PNPLA1 and evaluation of novel therapeutic interventions
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Rossel, S. V. J., primary, Clabbers, J. M. K., additional, Steijlen, P. M., additional, van den Akker, P. C., additional, Spuls, P. I., additional, Middelkamp Hup, M. A., additional, van Maarle, M. C., additional, Vreeburg, M., additional, Bolling, M. C., additional, van Geel, M., additional, and Gostyński, A., additional
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- 2023
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13. Real‐world reported adverse events related to systemic immunomodulating therapy in patients with atopic dermatitis: Results from the TREAT NL (TREatment of ATopic eczema, the Netherlands) registry.
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Musters, A. H., van Lookeren, F. L., van der Gang, L. F., Middelkamp‐Hup, M. A., Bosma, A. L., Jessurun, N. T., Lapeere, H., Nguyen, A. L., Ouwerkerk, W., de Schepper, S., Gerbens, L. A. A., and Spuls, P. I.
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ATOPIC dermatitis ,DRUG side effects ,CHILD patients ,MEIBOMIAN glands ,MYCOPHENOLIC acid ,ECTOPIC pregnancy - Abstract
Background: Evidence on the (long‐term) safety of systemic immunomodulating therapies in atopic dermatitis (AD) generated by real‐world data is sparse. Objectives: To describe real‐world reported adverse drug reactions (AEs) related to systemic immunomodulating therapy in patients with AD and to compare the incidence rates of AEs with the Summaries of Product Characteristics (SmPCs). Methods: We conducted an observational prospective multi‐centre cohort study, using the TREAT NL registry. All severe AEs, AEs of special interest and serious AEs in adult and paediatric patients on systemic immunomodulating treatment (ciclosporin, methotrexate, azathioprine, mycophenolic acid, dupilumab, tralokinumab, baricitinib and upadacitinib) were assessed. Incidences rates of all (potentially) drug‐related AEs were standardized in patient years and compared to the cumulative incidences in the associated SmPCs. Results: We collected 422 patient years of safety data from 266 patients, of whom 129 (48.5%) reported a total of 224 (potentially) drug‐related AEs. Compared to dupilumab's SmPC, higher incidence rates were found for four AEs (reported ≥5 times): eosinophilia, blepharitis, dry eyes and head and neck erythema (i.e. dupilumab facial redness). A higher incidence rate of fatigue was found in patients on oral methotrexate in our cohort compared to the SmPC. Two new drug‐related AEs (reported ≥5 times) were found in patients on dupilumab, including non‐infectious conjunctivitis and meibomian gland dysfunction. Conclusions: Real‐world reported AEs captured in AD patient registries can add information on the estimated incidence of AEs and benefit clinical decision aids. Future studies using data derived from the TREAT NL registry combined with data from other registries within the TREAT Registry Taskforce will provide more information on (rare) AEs associated with immunomodulating therapy in AD patients. [ABSTRACT FROM AUTHOR]
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- 2024
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14. Phototherapy for atopic dermatitis: A survey of European practice.
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Steyn, M., Gerbens, L. A. A., Spuls, P. I., Mashayekhi, S., Deleuran, M., Barbarot, S., Wollenberg, A., Ferguson, J., Ibbotson, S., and Flohr, C.
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ATOPIC dermatitis ,PHOTOTHERAPY ,CHILD patients ,PHOTOCHEMOTHERAPY ,RANDOMIZED controlled trials - Abstract
Background: Phototherapy is used to treat atopic dermatitis (AD). Evidence for its efficacy, impact on quality of life, cost‐effectiveness and short‐ and long‐term safety with real‐life usage is weak. Objectives: We established a taskforce to examine how phototherapy is currently being used as a treatment for AD across the United Kingdom and Europe to inform our understanding and guide future research into management of patients with AD using UV‐based phototherapies. Methods: An anonymous electronic multiple‐response survey exploring phototherapy prescribing practices and experience of phototherapy modalities was developed by the study authors and sent to members of phototherapy networks from the United Kingdom and Europe. Responses were received between February and July 2021. Results: About 144 respondents from 27 European countries completed the survey. NBUVB was the most widely used [n = 138 (96%)]. Home‐based NBUVB was available in 8/27 countries (25/144 respondents, 17%). Oral psoralen‐UVA (PUVA) was more widely available than bath PUVA (n = 106, 74% vs. n = 60, 42%) and used mainly in adult patients. 49/144 (34%) of respondents had access to UVA1. Phototherapy would be considered instead of systemic treatment in 96% of adults and 82% of children for NBUVB, versus 40% of adults and 3% of children for PUVA. Starting doses, standard dosing increments, length of treatment courses, lifetime limits for treatments and thresholds for performing annual skin assessments varied between responders. Conclusions: NBUVB was the most widely used phototherapy for AD in adult and paediatric patients, while PUVA and UVA1 were less used. Prescribing practices varied considerably, highlighting the lack of consensus practice in many different aspects of phototherapy for the treatment of AD in children and adults. This indicates that further studies are required to determine optimal phototherapeutic regimens for AD and informs our understanding of parameters that should be included in future high‐quality randomized controlled trials (RCT) of phototherapy. [ABSTRACT FROM AUTHOR]
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- 2024
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15. The effects of systemic immunomodulatory treatments on COVID-19 outcomes in patients with atopic dermatitis: Results from the global SECURE-AD registry
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Musters, A. H., Broderick, C., Prieto-Merino, D., Chiricozzi, Andrea, Damiani, G., Peris, Ketty, Dhar, S., De, A., Freeman, E., Arents, B. W. M., Burton, T., Bosma, A. L. -A. L., Chi, C. -C., Fletcher, G., Drucker, A. M., Kabashima, K., de Monchy, E. F., Panda, M., Wall, D. R., Vestergaard, C., Mahe, E., Bonzano, L., Kattach, L., Napolitano, M., Ordonez-Rubiano, M. F., Haufe, E., Patruno, C., Irvine, A. D., Spuls, P. I., Flohr, C., Chiricozzi A. (ORCID:0000-0002-6739-0387), Peris K. (ORCID:0000-0002-5237-0463), Musters, A. H., Broderick, C., Prieto-Merino, D., Chiricozzi, Andrea, Damiani, G., Peris, Ketty, Dhar, S., De, A., Freeman, E., Arents, B. W. M., Burton, T., Bosma, A. L. -A. L., Chi, C. -C., Fletcher, G., Drucker, A. M., Kabashima, K., de Monchy, E. F., Panda, M., Wall, D. R., Vestergaard, C., Mahe, E., Bonzano, L., Kattach, L., Napolitano, M., Ordonez-Rubiano, M. F., Haufe, E., Patruno, C., Irvine, A. D., Spuls, P. I., Flohr, C., Chiricozzi A. (ORCID:0000-0002-6739-0387), and Peris K. (ORCID:0000-0002-5237-0463)
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Background: Limited data are available on the effects of systemic immunomodulatory treatments on COVID-19 outcomes in patients with atopic dermatitis (AD). Objective: To investigate COVID-19 outcomes in patients with AD treated with or without systemic immunomodulatory treatments, using a global registry platform. Methods: Clinicians were encouraged to report cases of COVID-19 in their patients with AD in the Surveillance Epidemiology of Coronavirus Under Research Exclusion for Atopic Dermatitis (SECURE-AD) registry. Data entered from 1 April 2020 to 31 October 2021 were analysed using multivariable logistic regression. The primary outcome was hospitalization from COVID-19, according to AD treatment groups. Results: 442 AD patients (mean age 35.9 years, 51.8% male) from 27 countries with strongly suspected or confirmed COVID-19 were included in analyses. 428 (96.8%) patients were treated with a single systemic therapy (n = 297 [67.2%]) or topical therapy only (n = 131 [29.6%]). Most patients treated with systemic therapies received dupilumab (n = 216). Fourteen patients (3.2%) received a combination of systemic therapies. Twenty-six patients (5.9%) were hospitalized. No deaths were reported. Patients treated with topical treatments had significantly higher odds of hospitalization, compared with those treated with dupilumab monotherapy (odds ratio (OR) 4.65 [95%CI 1.71–14.78]), including after adjustment for confounding variables (adjusted OR (aOR) 4.99 [95%CI 1.4–20.84]). Combination systemic therapy which did not include systemic corticosteroids was associated with increased odds of hospitalization, compared with single agent non-steroidal immunosuppressive systemic treatment (OR 8.09 [95%CI 0.4–59.96], aOR 37.57 [95%CI 1.05–871.11]). Hospitalization was most likely in patients treated with combination systemic therapy which included systemic corticosteroids (OR 40.43 [95%CI 8.16–207.49], aOR 45.75 [95%CI 4.54–616.22]). Conclusions: Overall, the risk
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- 2023
16. Measurement instruments for the core outcome set of congenital melanocytic naevi and an assessment of the measurement properties according to COSMIN:a systematic review
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Fledderus, A. C., Boom, T., Legemate, C. M., van der Horst, C. M.A.M., Spuls, P. I., Fledderus, A. C., Boom, T., Legemate, C. M., van der Horst, C. M.A.M., and Spuls, P. I.
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Background: Congenital melanocytic naevi (CMN) can impact on patients’ lives due to their appearance and the risk they carry of neurological complications or melanoma development. The development of a core outcome set (COS) will allow standardised reporting and enable comparison of outcomes. This will help to improve guidelines. In previous research, relevant stakeholders reached a consensus over which core outcomes should be measured in any future care or research. The next step of the COS development is to select the appropriate measurement instruments. Aim: Step 1: to update a systematic review identifying all core outcomes and measurement instruments available for CMN. Step 2: to evaluate the measurement properties of the instruments for the core outcomes. Methods: This study was registered in PROSPERO and performed according to the PRISMA checklist. Step 1 includes a literature search in EMBASE (Ovid), PubMed and the Cochrane Library to identify core outcomes and instruments previously used in research of CMN. Step 2 yields a systematic search for studies on the measurement properties of instruments that were either developed or validated for CMN, including a methodological quality assessment following the COSMIN methodology. Results: Step 1 included twenty-nine studies. Step 2 yielded two studies, investigating two quality of life measurement instruments. Conclusion: Step 1 provided an overview of outcomes and instruments used for CMN. Step 2 showed that additional research on measurement properties is needed to evaluate which instruments can be used for the COS of CMN. This study informs the instrument selection and/or development of new instruments.
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- 2023
17. Mapping exercise and status update of eight established registries within the TREatment of ATopic eczema (TREAT) Registry Taskforce
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Bosma, A. L., Musters, A. H., Bloem, M., Gerbens, L. A. A., Middelkamp-Hup, M. A., Haufe, E., Schmitt, J., Barbarot, S., Seneschal, J., Staumont-Sallé, D., Johansson, E. K., Bradley, M., von Kobyletzki, Laura B., Vittrup, I., Ruge, I. Frier, Thyssen, Jacob P., Vestergaard, C., de Vega, M., García-Doval, I., Chiricozzi, A., Stingeni, Luca, Calzavara-Pinton, Piergiacomo, Ardern-Jones, M. R., Reynolds, N. J., Flohr, C., Spuls, P. I., Bosma, A. L., Musters, A. H., Bloem, M., Gerbens, L. A. A., Middelkamp-Hup, M. A., Haufe, E., Schmitt, J., Barbarot, S., Seneschal, J., Staumont-Sallé, D., Johansson, E. K., Bradley, M., von Kobyletzki, Laura B., Vittrup, I., Ruge, I. Frier, Thyssen, Jacob P., Vestergaard, C., de Vega, M., García-Doval, I., Chiricozzi, A., Stingeni, Luca, Calzavara-Pinton, Piergiacomo, Ardern-Jones, M. R., Reynolds, N. J., Flohr, C., and Spuls, P. I.
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BACKGROUND: the TREatment of ATopic eczema (TREAT) Registry Taskforce is a collaborative international network of registries collecting data of atopic eczema (AE) patients receiving systemic and phototherapy with the common goal to provide long-term real-world data on the effectiveness, safety and cost-effectiveness of therapies. A core dataset, consisting of domains and domain items with corresponding measurement instruments, has been developed to harmonize data collection. OBJECTIVES: we aimed to give an overview of the status and characteristics of the eight established TREAT registries, and to perform a mapping exercise to examine the degree of overlap and pooling ability between the national registry datasets. This will allow us to determine which research questions can be answered in the future by pooling data. METHODS: all eight registries were asked to share their dataset and information on the current status and characteristics. The overlap between the core dataset and each registry dataset was identified (according to the domains, domain items and measurement instruments of the TREAT core dataset). RESULTS AND CONCLUSIONS: a total of 4,702 participants have been recruited in the 8 registries as of 1st of May 2022. Of the 69 core dataset domain items, data pooling was possible for 69 domain item outcomes in TREAT NL (the Netherlands), 61 items in A-STAR (UK and Ireland), 38 items in TREATgermany (Germany), 36 items in FIRST (France), 33 items in AtopyReg (Italy), 29 items in Biobadatop (Spain), 28 items in SCRATCH (Denmark) and 20 items in SwedAD (Sweden). Pooled analyses across all registries can be performed on multiple important domain items, covering the main aims of analyzing data on the (cost-)effectiveness and safety of AE therapies. These results will facilitate future comparative or joint analyses.
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- 2023
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18. Mapping exercise and status update of eight established registries within the TREatment of ATopic eczema (TREAT) Registry Taskforce
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Bosma, A L, Musters, A H, Bloem, M, Gerbens, L A A, Middelkamp-Hup, M A, Haufe, E, Schmitt, J, Barbarot, S, Seneschal, J, Staumont-Sallé, D, Johansson, E K, Bradley, M, von Kobyletzki, L B, Vittrup, I, Ruge, I Frier, Thyssen, Jacob P, Vestergaard, C, de Vega, M, García-Doval, I, Chiricozzi, A, Stingeni, Luca, Calzavara-Pinton, Piergiacomo, Ardern-Jones, M R, Reynolds, N J, Flohr, C, Spuls, P I, Chiricozzi, A (ORCID:0000-0002-6739-0387), Bosma, A L, Musters, A H, Bloem, M, Gerbens, L A A, Middelkamp-Hup, M A, Haufe, E, Schmitt, J, Barbarot, S, Seneschal, J, Staumont-Sallé, D, Johansson, E K, Bradley, M, von Kobyletzki, L B, Vittrup, I, Ruge, I Frier, Thyssen, Jacob P, Vestergaard, C, de Vega, M, García-Doval, I, Chiricozzi, A, Stingeni, Luca, Calzavara-Pinton, Piergiacomo, Ardern-Jones, M R, Reynolds, N J, Flohr, C, Spuls, P I, and Chiricozzi, A (ORCID:0000-0002-6739-0387)
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- 2022
19. Can serum biomarkers predict the outcome of systemic immunosuppressive therapy in adult atopic dermatitis patients?
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Hurault, G., primary, Roekevisch, E., additional, Schram, M. E., additional, Szegedi, K., additional, Kezic, S., additional, Middelkamp‐Hup, M. A., additional, Spuls, P. I., additional, and Tanaka, R. J., additional
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- 2022
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20. Sex differences in adverse drug reactions from Adalimumab and etanercept in patients with inflammatory rheumatic diseases
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Gosselt, Helen R., van Lint, Jette A., Kosse, Leanne J., Spuls, Phyllis I., Vonkeman, Harald E., Tas, Sander W., Hoentjen, Frank, Nurmohamed, Michael T., van den Bemt, Bart J.F., van Doorn, Martijn B.A., and Jessurun, Naomi T.
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ABSTRACTBackgroundWe examine sex differences in relation to the nature, frequency, and burden of patient-reported adverse drug reactions (ADRs) in patients with inflammatory rheumatic diseases.Research design and methodsRheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis patients using etanercept or adalimumab from the Dutch Biologic Monitor were sent bimonthly questionnaires concerning experienced ADRs. Sex differences in the proportion and nature of reported ADRs were assessed. Additionally, 5-point Likert-type scales reported for the burden of ADRs, were compared between sexes.ResultsIn total 748 consecutive patients were included (59% female). From the women 55% reported ≥1 ADR, which was significantly higher than 38% of the men that reported ≥1 ADR (p < 0.001). A total of 882 ADRs were reported comprising 264 distinct ADRs. The nature of the reported ADRs differed significantly between both sexes (p = 0.02). Women in particular reported more injection site reactions than men. The burden of ADRs was similar between sexes.ConclusionsSex differences in the frequency and nature of ADRs, but not in ADR burden, exist during treatment with adalimumab and etanercept in patients with inflammatory rheumatic diseases. This should be taken into consideration when investigating and reporting results on ADRs and when counseling patients in daily clinical practice.
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- 2023
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21. Analysis and visualization of the course and burden over time of adverse drug reactions (ADRs) attributed to TNFα-inhibitors in patients with inflammatory rheumatic diseases (IRDs)
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de Boer, Merel, Gosselt, Helen R, Jansen, Jurriaan, van Doorn, Martijn B.A, Hoentjen, Frank, Nurmohamed, Michael T, Spuls, Phyllis I, Tas, Sander W, Vonkeman, Harald E, and Jessurun, Naomi T
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ABSTRACTBackgroundWe aimed to investigate course and burden over time of ADRs attributed to TNFα-inhibitors in IRD-patients, and whether Sankey diagrams and polar plots can visualize this.Research design and methodsData on ADRs experienced during the Dutch Biologic Monitor (January 2017 till December 2022) were used in this study. We selected IRD-patients using a TNFα-inhibitor, reporting skin reactions/infections/injection site reactions and completing ≥3 questionnaires (i.e. the initial report and ≥2 follow-ups). Course was scored as worsening/improving/remaining stable/resolving and as (non-)recurrent. Patients scored burden from 1 (no burden) to 5 (very high burden). Sankey diagrams and polar plots visualized this.Results202 patients were included, reporting 353 ADRs. Most skin reactions were stable (25.0%). Most infections resolved (50.8%). Injection site reactions were mostly recurrent (72.3%). Skin reactions and infections tended to decrease in burden . Infections had highest burden at start, which mostly decreased over time. Injection site reactions had a low and stable burden.ConclusionsSkin reactions attributed to TNFα-inhibitors by IRD-patients are stable with a slightly decreasing burden over time. Infections have highest burden at start but resolved mostly. Injection site reactions have a low and stable burden. Sankey diagrams and polar plots are suitable to visualize this.
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- 2023
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22. Comparison of real-world treatment outcomes of systemic immunomodulating therapy in atopic dermatitis patients with dark and light skin types
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Bosma, Angela L., Ouwerkerk, Wouter, Heidema, Madeline J., Prieto-Merino, David, Ardern-Jones, Michael R., Beattie, Paula, Brown, Sara J., Ingram, John R., Irvine, Alan D., Ogg, Graham, Patel, Prakash, Reynolds, Nick J., Hearn, R.M. Ross, Wan, Mandy, Warren, Richard B., Woolf, Richard T., Hyseni, Ariënna M., Gerbens, Louise A.A., Spuls, Phyllis I., Flohr, Carsten, and Middelkamp-Hup, Maritza A.
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Few data exist on differences in treatment effectiveness and safety in atopic dermatitis patients of different skin types.
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- 2023
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23. Sex stratification of adverse events should be included in studies about skin disease.
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Spuls, P. I.
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- 2024
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24. From the Cochrane Library: Phototherapy for atopic eczema.
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O'Connell, Katie A., Kim, Lori S., Szeto, Mindy D., Sivesind, Torunn, Dellavalle, Robert P., Musters, Annelie H., and Spuls, Phyllis I.
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- 2022
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25. Clinical and humoral response after SARS-CoV-2 breakthrough infection in patients receiving immunosuppressant therapy.
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Stalman, Eileen W., Wieske, Luuk, Keijser, Jim B.D., van Dam, Koos P.J., Kummer, Laura Y.L., Wilbrink, Maarten F., van Kempen, Zoé L.E., Killestein, Joep, Volkers, Adriaan G., Tas, Sander W., Boekel, Laura, Wolbink, Gerrit J., van der Kooi, Anneke J., Raaphorst, Joost, Löwenberg, Mark, Takkenberg, R. Bart, D'Haens, Geert R.A.M., Spuls, Phyllis I., Bekkenk, Marcel W., and Musters, Annelie H.
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Despite impaired humoral response in patients treated with immunosuppressants (ISPs), recent studies found similar severity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) breakthrough infection compared to controls. One potential explanation is the rapid generation of humoral response on infection, but evidence is lacking. We investigated the longitudinal dynamics of the SARS-CoV-2 antibody repertoire after SARS-CoV-2 delta and omicron breakthrough infection in patients with immune-mediated inflammatory diseases (IMIDs) receiving ISP therapy and controls. As a prospective substudy of the national Target-to-B! (T2B!) consortium, we included IMID patients receiving ISPs therapy and controls who reported SARS-CoV-2 breakthrough infection between July 1, 2021, and April 1, 2022. To get an impression of the dynamics of the antibody repertoire, 3 antibody titers of wild-type RBD, wild-type S, and omicron RBD were measured at 4 time points after SARS-CoV-2 breakthrough infection. We included 302 IMID patients receiving ISPs and 178 controls. Antibody titers increased up to 28 days after breakthrough infection in both groups. However, in IMID patients receiving therapy with anti-CD20 and sphingosine-1 phosphate receptor modulators, antibody titers were considerably lower compared to controls. In the anti-TNF group, we observed slightly lower antibody titers in the early stages and a faster decline of antibodies after infection compared to controls. Breakthrough infections were mostly mild, and hospitalization was required in less than 1% of cases. Most ISPs do not influence the dynamics of the SARS-CoV-2 antibody repertoire and exhibit a rapid recall response with cross-reactive antibody clones toward new virus variants. However, in patients treated with anti-CD20 therapy or sphingosine-1 phosphate receptor modulators, the dynamics were greatly impaired, and to a lesser extent in those who received anti-TNF. Nevertheless, only a few severe breakthrough cases were reported. [ABSTRACT FROM AUTHOR]
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- 2024
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26. Measuring Atopic Eczema Control and Itch Intensity in Clinical Practice: A Consensus Statement From the Harmonising Outcome Measures for Eczema in Clinical Practice (HOME-CP) Initiative
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Leshem, Yael A., Chalmers, Joanne R., Apfelbacher, Christian, Katoh, Norito, Gerbens, Louise A. A., Schmitt, Jochen, Spuls, Phyllis I., Thomas, Kim S., Howells, Laura, Williams, Hywel C., and Simpson, Eric L.
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IMPORTANCE: Measuring outcomes in clinical practice can aid patient care, quality improvement, and real-world evidence generation. The Harmonising Outcome Measures for Eczema (HOME) Clinical Practice initiative is developing a list of validated, feasible instruments to measure atopic eczema in clinical care. Prior work identified symptoms and long-term control as the most important domains to measure in clinical practice. The Patient-Oriented Eczema Measure (POEM) and the Patient-Oriented Scoring Atopic Dermatitis Index (PO-SCORAD) were recommended by consensus to measure symptoms in clinical practice, but a need for instruments to measure itch intensity specifically was recognized. The HOME group also previously decided that long-term control should be captured by repeated measurements of eczema control. Recommended instruments to measure eczema control in clinical practice have not been defined. OBJECTIVE: To recommend instruments to measure eczema control and itch intensity in patients with atopic eczema in clinical practice. EVIDENCE REVIEW: Available instruments to measure eczema control and itch intensity were identified through systematic reviews, informing a consensus process held at the HOME VIII virtual online meeting (October 6 and October 9, 2020). Feasibility aspects were highlighted to optimize instrument selection for the clinical practice. Consensus on an instrument was reached if fewer than 30% of the voters disagreed. FINDINGS: Of 7 identified instruments, the Recap of Atopic Eczema (RECAP) and Atopic Dermatitis Control Tool (ADCT) were the recommended instruments to measure eczema control (3 of 63 [5%] and 7 of 69 [10%] of voters disagreed, respectively). A single-question patient global assessment garnered support, but the current available instrument did not reach consensus. Six available itch-intensity instruments were identified. Of them, 3 instruments were recommended by consensus: a peak 24-hour numeric rating scale (NRS)-itch, and 1-week NRS-itch instruments from the Patient-Reported Outcomes Measurement Information System (PROMIS) Itch Questionnaire, measuring average and peak itch (11 of 63 [17%], 14 of 63 [22%], and 16 of 59 [27%] voters disagreed, respectively). CONCLUSIONS AND RELEVANCE: Clinicians and patients are encouraged to incorporate these well-validated, quick-to-perform, and easy-to-use instruments into their clinic, selecting the instruments that best fit their need. These assessments are meant to enhance, not replace, the patient–clinician encounter, and to support real-world research and health care improvement.
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- 2022
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27. The HOME Core outcome set for clinical trials of atopic dermatitis.
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Williams, Hywel C., Schmitt, Jochen, Thomas, Kim S., Spuls, Phyllis I., Simpson, Eric L., Apfelbacher, Christian J., Chalmers, Joanne R., Furue, Masutaka, Katoh, Norito, Gerbens, Louise A.A., Leshem, Yael A., Howells, Laura, Singh, Jasvinder A., and Boers, Maarten
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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. [ABSTRACT FROM AUTHOR]
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- 2022
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28. Barriers and facilitators for systematically registering adverse drug reactions in electronic health records: a qualitative study with Dutch healthcare professionals
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Geeven, Isa P. A. C., Jessurun, Naomi T., Wasylewicz, Arthur T. M., Drent, Marjolein, Spuls, Phyllis I., Hoentjen, Frank, van Puijenbroek, Eugène P., Vonkeman, Harald E., Grootens, Koen P., van Doorn, Martijn B. A., van Den Bemt, Bart J. F., and Bekker, Charlotte L.
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ABSTRACTBackgroundSystematically registering ADRs in electronic health records (EHRs) likely contribute to patient safety as it enables the exchange of drug safety data. Currently, ADRs registrations by healthcare professionals (HCPs) is suboptimal. This study aimed to identify barriers and facilitators perceived by HCPs to register ADRs systematically in EHRs.Research Design and MethodsA qualitative study with individual interviews was conducted among specialist physicians and hospital pharmacists from 10 different Dutch hospitals. A semi-structured interview guide was used to identify experienced barriers and facilitators for systematically registering ADRs. Data was analyzed following thematic analysis. Themes within barriers and facilitators were aligned with the Capability–Opportunity-Motivation–Behavior (COM-B) framework.ResultsIn total, 16 HCPs were interviewed. Identified barriers were: lack of knowledge to recognize ADRs, time constraints, inadequate IT system, lack of support, stuck in routine, and not recognizing the importance of registering ADRs. Identified facilitators were: enhanced knowledge and awareness of ADRs, functional IT systems, expanding accountability for registration, and motivation toward registering.ConclusionsBarriers and facilitators for registering spanned all aspects of the COM-B model and occurred in individual, social and environmental domains. Addressing these aspects could improve the registration of ADRs and may contribute to patient safety.
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- 2022
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29. Systemic Immunomodulatory Treatments for Atopic Dermatitis: Update of a Living Systematic Review and Network Meta-analysis
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Drucker, Aaron M., Morra, Deanna E., Prieto-Merino, David, Ellis, Alexandra G., Yiu, Zenas Z. N., Rochwerg, Bram, Di Giorgio, Sonya, Arents, Bernd W. M., Burton, Tim, Spuls, Phyllis I., Schmitt, Jochen, and Flohr, Carsten
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IMPORTANCE: Systemic treatments for atopic dermatitis are being evaluated primarily in placebo-controlled trials; network meta-analysis can provide relative efficacy and safety estimates for treatments that have not been compared head to head. OBJECTIVE: To compare reported measures of efficacy and assessments of safety in clinical trials of systemic treatments for atopic dermatitis in a living systematic review and network meta-analysis. DATA SOURCES: The Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Latin American and Caribbean Health Science Information database, Global Resource of EczemA Trials database, and trial registries were searched through June 15, 2021. STUDY SELECTION: Randomized clinical trials examining 8 or more weeks of treatment with systemic immunomodulatory medications for moderate-to-severe atopic dermatitis were included after screening titles, abstracts, and papers in duplicate. DATA EXTRACTION AND SYNTHESIS: Data were abstracted in duplicate. Bayesian network meta-analyses and assessed Grading of Recommendations Assessment, Development and Evaluation certainty of evidence were performed. The updated analysis was completed from June to December 2021. MAIN OUTCOMES AND MEASURES: Outcomes include change in Eczema Area and Severity Index (EASI), Patient Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), and Peak Pruritus Numeric Rating Scales (PP-NRS). RESULTS: Since October 2019, 21 new studies were added, for a total of 60 trials with 16 579 patients. Up to 16 weeks of treatment in adults, abrocitinib, 200 mg daily (mean difference [MD], 2.2; 95% credible interval [CrI], 0.2-4.0; high certainty) and upadacitinib, 30 mg daily (MD, 2.7; 95% CrI, 0.6-4.7; high certainty) were associated with reduced EASI slightly more than dupilumab, 600 mg then 300 mg every 2 weeks. Abrocitinib, 100 mg daily (MD, −2.1; 95% CrI, −4.1 to −0.3; high certainty), baricitinib, 4 mg daily (MD, −3.2; 95% CrI, −5.7 to −0.8; high certainty), baricitinib, 2 mg daily (MD, −5.2; 95% CrI, −7.5 to −2.9; high certainty) and tralokinumab, 600 mg then 300 mg every 2 weeks (MD, −3.5; 95% CrI, −5.8 to −1.3; high certainty) were associated with reduced EASI slightly less than dupilumab. There was little or no difference between upadacitinib, 15 mg daily, and dupilumab (MD, 0.2; 95% CrI, −1.9 to 2.2; high certainty). The pattern of results was similar for POEM, DLQI, and PP-NRS. CONCLUSIONS AND RELEVANCE: In this systematic review and meta-analysis, abrocitinib, 200 mg; and upadacitinib, 30 mg daily, were associated with slightly better scores than dupilumab, and upadacitinib, 15 mg daily, was associated with similar scores to dupilumab. Abrocitinib, 100 mg daily, baricitinib, 4 mg and 2 mg daily, and tralokinumab, 300 mg, every 2 weeks were associated with slightly worse scores.
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- 2022
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30. International eDelphi Study to Reach Consensus on the Methotrexate Dosing Regimen in Patients With Psoriasis
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van Huizen, Astrid M., Menting, Stef P., Gyulai, Rolland, Iversen, Lars, van der Kraaij, Gayle E., Middelkamp-Hup, Maritza A., Warren, Richard B., Spuls, Phyllis I., Schejtman, Adrián A., Egeberg, Alexander, Firooz, Alireza, Kumar, Alur S., Oakley, Amanda, Foulkes, Amy, Ramos, Andrea Machado Coelho, Fougerousse, Anne-Claire, Carija, Antoanela, Akman-Karakas, Ayse, Horváth, Barbara, Fábos, Béata, Matlock, Benjamin Hidalgo, Claréus, Birgitta Wilson, Castro, Carla, Ferrándiz, Carlos, Correa, Carolina Cortés, Marchesi, Carolina, Goujon, Catherine, Gonzalez, Cesar, Maldonado-García, César, Hong, Chih-ho, Griffiths, Christopher E.M., Vestergaard, Christian, Echeverría, Christina Mariela, de la Cruz, Claudia, Conrad, Curdin, Törocsik, Dániel, Drvar, Daniela Ledic, Balak, Deepak, Jullien, Denis, Appelen, Diebrecht, Kim, Dong Hyun, de Jong, Elke M.G.J., El Gamal, Emad, Laffitte, Emmanuel, Mahé, Emmanuel, Sonkoly, Enikö, Colombo, Erika Páez, Vilarrasa, Eva, Willaert, Fabienne, Novoa, Farah D., Handjani, Farhad, Valenzuela, Fernando, Vílchez-Márquez, Francisco, Gonzalez, Gabriela Otero, Krisztián, Gáspár, Damiani, Giovanni, Krnjevic-Pezic, Gordana, Pellerano, Graciela, Carretero, Gregorio, Hunter, Hamish J. A., Riad, Hassan, Oon, Hazel H., Boonen, Hugo P.J., Moussa, Iftin Osman, García-Doval, Ignacio, Csányi, Ildíko, Brajac, Ines, Turchin, Irina, Grozdev, Ivan, Weinberg, Jeffrey M., Nicolopoulos, Jenny, Wells, Jillian, Lambert, Jo L.W., Ingram, John R., Prinz, Jörg Christoph, de Souza Sittart, José Alexandre, Sanchez, Jose Luis, Hsiao, Josephine Pa-Fan, Castro-Ayarza, Juan Raul, Maul, Julia-Tatjana, van den Reek, Juul M.P.A., Trcko, Katarina, Barber, Kirk, Reich, Kristian, Gebauer, Kurt Aaron, Khobzei, Kuzma, Maul, Lara V., Massari, Larisa Prpic, Fardet, Laurence, le Cleach, Laurence, Misery, Laurent, Chandrashekar, Laxmisha, Muresanu, Lidia Irinel, Lecluse, Lidian, Skov, Lone, Frez, Ma. Lorna, Babic, Lucija Tomic, Puig, Lluís, Gomez, Luis Castro, Ramam, M., Dutil, Maha, El-Sayed, Mahira Hamdy, Olszewska, Malgorzata, Schram, Mandy Elvira, Franco, Manuel Dario, Llamas-Velasco, Mar, Gonçalo, Margarida, Velásquez-Lopera, Margarita M., Abad, Maria Eugenia, de Oliveira, Maria de Fátima Santos Paim, Seyger, Marieke M. B., Kaštelan, Marija, Rademaker, Marius, Sikora, Mariusz, Lebwohl, Mark, Wiseman, Marni C., Ferran, Marta, van Doorn, Martijn, Danespazhooh, Maryam, Bylaite-Bucinskiene, Matilda, Gooderham, Melinda J., Polic, Melita Vukšic, de Rie, Menno A., Zheng, Min, Gómez-Flores, Minerva, Salleras i Redonnet, Montse, Silverberg, Nanette B., Doss, Nejib, Yawalkar, Nikhil, Chosidow, Olivier, Zargari, Omid, de la Cueva, Pablo, Fernandez-Peñas, Pablo, Cárdenas Rojas, Paola J., Gisondi, Paolo, Grewal, Parbeer, Sator, Paul, Luna, Paula Carolina, Félix, Paulo Antonio Oldani, Varela, Paulo, Holló, Péter, Cetkovska, Petra, Calzavara-Pinton, Piergiacomo, Ghislain, Pierre-Dominique, Araujo, Raquel Ruiz, Romiti, Ricardo, Kui, Róbert, Ceovic, Romana, Vender, Ronald, Lafuente-Urrez, Rosario Fátima, del-Río, Rubén, Gulin, Sandra J., Handa, Sanjeev, Mahil, Satveer K., Kolalapudi, Seetharam A., Marrón, Servando E., Azimi, Seyyede Zeinab, Janmohamed, Sherief R., da Cruz Costa, Sidney Augusto, Choon, Siew Eng, Urbancek, Slavomir, Ayanlowo, Olusola, Margasin, Susana M., Wong, Tak-Wah, Mälkönen, Tarja, Hurtová, Tatiana, Reciné, Tatiana Riveros, Huldt-Nystrøm, Theis, Torres, Tiago, Liu, Tong-Yun, Leonidze, Tsira, Sharma, Vinod Kumar, Weightman, Warren, Gulliver, Wayne, and Veldkamp, Wendelien
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IMPORTANCE: A clear dosing regimen for methotrexate in psoriasis is lacking, and this might lead to a suboptimal treatment. Because methotrexate is affordable and globally available, a uniform dosing regimen could potentially optimize the treatment of patients with psoriasis worldwide. OBJECTIVE: To reach international consensus among psoriasis experts on a uniform dosing regimen for treatment with methotrexate in adult and pediatric patients with psoriasis and identify potential future research topics. DESIGN, SETTING, AND PARTICIPANTS: Between September 2020 and March 2021, a survey study with a modified eDelphi procedure that was developed and distributed by the Amsterdam University Medical Center and completed by 180 participants worldwide (55 [30.6%] resided in non-Western countries) was conducted in 3 rounds. The proposals on which no consensus was reached were discussed in a conference meeting (June 2021). Participants voted on 21 proposals with a 9-point scale (1-3 disagree, 4-6 neither agree nor disagree, 7-9 agree) and were recruited through the Skin Inflammation and Psoriasis International Network and European Academy of Dermatology and Venereology in June 2020. Apart from being a dermatologist/dermatology resident, there were no specific criteria for participation in the survey. The participants worked mainly at a university hospital (97 [53.9%]) and were experienced in treating patients with psoriasis with methotrexate (163 [91.6%] had more than 10 years of experience). MAIN OUTCOMES AND MEASURES: In a survey with eDelphi procedure, we tried to reach consensus on 21 proposals. Consensus was defined as less than 15% voting disagree (1-3). For the consensus meeting, consensus was defined as less than 30% voting disagree. RESULTS: Of 251 participants, 180 (71.7%) completed all 3 survey rounds, and 58 participants (23.1%) joined the conference meeting. Consensus was achieved on 11 proposals in round 1, 3 proposals in round 2, and 2 proposals in round 3. In the consensus meeting, consensus was achieved on 4 proposals. More research is needed, especially for the proposals on folic acid and the dosing of methotrexate for treating subpopulations such as children and vulnerable patients. CONCLUSIONS AND RELEVANCE: In this eDelphi consensus study, consensus was reached on 20 of 21 proposals involving methotrexate dosing in patients with psoriasis. This consensus may potentially be used to harmonize the treatment with methotrexate in patients with psoriasis.
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- 2022
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31. Patients’ perspectives on a drug safety monitoring system for immune-mediated inflammatory diseases based on patient-reported outcomes
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Kosse, Leanne J, Weits, Gerda, Vonkeman, Harald E, Tas, Sander W, Hoentjen, Frank, Van Doorn, Martijn BA, Spuls, Phyllis I, D’Haens, Geert R, Nurmohamed, Michael T, van Puijenbroek, Eugène P, Van Den Bemt, Bart JF, and Jessurun, Naomi T
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ABSTRACTBackgroundPatient-reported outcomes (PROs) on adverse drug reactions (ADRs) are increasingly used in cohort event monitoring (CEM) to obtain a better understanding of patients’ real-world experience with drugs. Despite the leading role for patients, little is known about their perspectives on CEM systems.Research design and methodsIn a cross-sectional open survey following the rationale of the Technology Acceptance Model, we aimed to obtain insight in patients’ perspectives on the perceived usefulness, ease of use and attitude toward using a PRO-based drug safety monitoring system for ADRs attributed to biologics.ResultsPatients considered structural reporting of ADRs in web-based questionnaires as useful and not burdensome. It was preferred to link the questionnaire frequency to regular hospital consultations or the biologic administration schedule. Various respondents were interested in sharing questionnaires with their medical specialist (49.0%) or pharmacist (34.2%), and suggested to minimize the questionnaire frequency in case of an unaltered situation or absence of ADRs.ConclusionsPatients’ perspectives should be considered in the setup of PRO-based CEM studies, as this contributes to data quality and patient centeredness. Since incorporation of patients’ perspectives in CEM studies is indispensable, a delicate balance should be found between user-friendliness and study aims.
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- 2021
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32. Consensus on the therapeutic management of atopic dermatitis ‒ Brazilian Society of Dermatology: an update on phototherapy and systemic therapy using e-Delphi technique
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Orfali, Raquel Leao, Lorenzini, Daniel, Bressan, Aline, Tanaka, Anber Ancel, Cerqueira, Ana Maria Mósca de, Hirayama, André da Silva, Ramos, Andréa Machado Coelho, Proença, Carolina Contin, Silva, Claudia Marcia de Resende, Laczynski, Cristina Marta Maria, Carneiro, Francisca Regina, Duarte, Gleison, Filho, Gunter Hans, Gonçalves, Heitor de Sá, Melo, Ligia Pessoa de, Azulay-Abulafia, Luna, Weber, Magda Blessmann, Rivitti-Machado, Maria Cecília, Zaniboni, Mariana Colombini, Ogawa, Marília, Pires, Mario Cezar, Ianhez, Mayra, Felix, Paulo Antonio Oldani, Bonamigo, Renan, Takaoka, Roberto, Lazarini, Rosana, Cestari, Silmara, Mayor, Silvia Assumpção Soutto, Cestari, Tania, Oliveira, Zilda Najjar Prado de, Spuls, Phyllis I., Gerbens, Louise A.A., and Aoki, Valeria
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This publication is an update of the “Consensus on the therapeutic management of atopic dermatitis – Brazilian Society of Dermatology” published in 2019, considering the novel, targeted-oriented systemic therapies for atopic dermatitis. The initial recommendations of the current consensus for systemic treatment of patients with atopic dermatitis were based on a recent review of scientific published data and a consensus was reached after voting. The Brazilian Society of Dermatology invited 31 experts from all regions of Brazil and 2 international experts on atopic dermatitis who fully contributed to the process. The methods included an e-Delphi study to avoid bias, a literature search and a final consensus meeting. The authors added novel approved drugs in Brazil and the indication for phototherapy and systemic therapy for AD. The therapeutical response to systemic treatment is hereby reported in a suitable form for clinical practice and is also part of this updated manuscript.
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- 2023
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33. Clinical characteristics associated with pain in patients with peripheral vascular malformations.
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Stor, Merel L.E., Lokhorst, Max M., Horbach, Sophie E.R., Young-Afat, Danny A., Kappen, Tijmen M., van Hout, Naomi M., Spuls, Phyllis I., and van der Horst, Chantal M.A.M.
- Abstract
Vascular malformations (VM) can negatively impact the patient's quality of life (QoL). Pain is a common problem in these patients. The aim of this study was to investigate risk factors associated with pain and to assess how pain affects QoL. This prospective cross-sectional study was conducted in a tertiary vascular anomaly expertise center. Between June and December 2020, all patients from our local database (334 adults and 189 children) with peripheral VMs were invited to complete the Outcome Measures for VAscular MAlformations questionnaire to evaluate the presence, frequency, and intensity of pain. Additionally, patients were asked to complete several Patient-Reported Outcome Measurement Information System scales to evaluate their QoL. Risk factors associated with pain were identified in bivariate analysis and multivariable logistic regression. QoL domains were compared between patients who experienced pain and patients who did not. A total of 164 patients completed the questionnaire about pain and 133 patients completed all QoL questionnaires. Approximately one-half of the patients (52%) reported pain in the past four weeks and 57% of these patients reported pain daily or several times a week. Female sex (P =.009), lesions located in the upper extremity (P <.001) or lower extremity (P <.001), and intramuscular/intraosseous lesions (P =.004) were independently associated with the presence of pain. The following QoL domains were diminished in patients who experienced pain in comparison with patients who did not: pain interference (P <.001), physical functioning (P <.001), and social participation (P <.001) in adults, and pain interference (P =.001), mobility (P =.001), and anxiety (P =.024) in children. Pain is a frequently reported complaint in patients with VMs and is present in approximately one-half of the patients. Patients with lesions located in the upper or lower extremity, intramuscular/intraosseous lesions, and female patients are more likely to experience pain. The presence of pain negatively impacted patients' QoL. Although VM are a benign condition and expectative management is frequently applied, our study shows that pain is a serious concern and needs to be actively assessed. Pain is a sign of various etiologies and should be examined to properly treat the pain. [ABSTRACT FROM AUTHOR]
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- 2022
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34. The Eczema Area and Severity Index: An update of progress and challenges in its measurement of atopic dermatitis after 20 years of use.
- Author
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Jacobson, M. E., Morimoto, R. Y., Leshem, Y. A., Howells, L., Williams, H. C., Grinich, E., Gerbens, L. A. A., Spuls, P. I., Schmitt, J., Staley, B., Baghoomian, W., Katoh, N., Thomas, K. S., Apfelbacher, C. J., and Simpson, E. L.
- Subjects
- *
CHILD patients , *ATOPIC dermatitis , *SYMPTOMS , *CLINICAL medicine , *CLINICAL trials - Abstract
The Eczema Area and Severity Index is an investigator‐assessed instrument reporting clinical signs of atopic dermatitis. The instrument is extensively validated in both adult and paediatric populations and recommended as a core outcome measure to assess clinical signs by the Harmonising Outcome Measures for Eczema initiative in clinical trials and was recently recommended as an option to measure signs in clinical practice. Here, we review the validation of the instrument using standard assessment criteria, explore controversies and challenges to its universal applicability and highlight future electronic adaptations. We find that the instrument demonstrates adequate performance in the measurement properties recommended by the COnsensus‐based Standards for the selection of health Measurement INstruments initiative for instruments reporting clinical signs, is clinically interpretable, and is suitable for all atopic dermatitis severities. Some validation gaps remain. Information reporting on its performance in diverse populations, with emphasis on deeply pigmented skin, is promising though limited. Technological adaptations are demonstrating promising initial validation results and may facilitate remote and/or automated assessments assisting clinical care and decentralized clinical trials in the future. We find no strong evidence limiting its use in trials or clinical practice although questions pertaining to the effect of investigator training remain. We recommend that the Eczema Area and Severity Index be used in all interventional atopic dermatitis trials and be considered alongside other recommended clinical practice severity instruments. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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35. Measurement instruments for the core outcome set of congenital melanocytic naevi and an assessment of the measurement properties according to COSMIN: a systematic review.
- Author
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Fledderus AC, Boom T, Legemate CM, van der Horst CMAM, and Spuls PI
- Abstract
Background: Congenital melanocytic naevi (CMN) can impact on patients' lives due to their appearance and the risk they carry of neurological complications or melanoma development. The development of a core outcome set (COS) will allow standardised reporting and enable comparison of outcomes. This will help to improve guidelines. In previous research, relevant stakeholders reached a consensus over which core outcomes should be measured in any future care or research. The next step of the COS development is to select the appropriate measurement instruments., Aim: Step 1: to update a systematic review identifying all core outcomes and measurement instruments available for CMN. Step 2: to evaluate the measurement properties of the instruments for the core outcomes., Methods: This study was registered in PROSPERO and performed according to the PRISMA checklist. Step 1 includes a literature search in EMBASE (Ovid), PubMed and the Cochrane Library to identify core outcomes and instruments previously used in research of CMN. Step 2 yields a systematic search for studies on the measurement properties of instruments that were either developed or validated for CMN, including a methodological quality assessment following the COSMIN methodology., Results: Step 1 included twenty-nine studies. Step 2 yielded two studies, investigating two quality of life measurement instruments., Conclusion: Step 1 provided an overview of outcomes and instruments used for CMN. Step 2 showed that additional research on measurement properties is needed to evaluate which instruments can be used for the COS of CMN. This study informs the instrument selection and/or development of new instruments., Competing Interests: The authors have no other financial or personal relationships relevant to this study to disclose., (© 2022 The Author(s).)
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- 2022
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36. Classifying atopic dermatitis: a systematic review of phenotypes and associated characteristics.
- Author
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Bosma AL, Ascott A, Iskandar R, Farquhar K, Matthewman J, Langendam MW, Mulick A, Abuabara K, Williams HC, Spuls PI, Langan SM, and Middelkamp-Hup MA
- Subjects
- Cross-Sectional Studies, Humans, Phenotype, Severity of Illness Index, Dermatitis, Atopic therapy, Eczema, Kaposi Varicelliform Eruption
- Abstract
Atopic dermatitis is a heterogeneous disease, accompanied by a wide variation in disease presentation and the potential to identify many phenotypes that may be relevant for prognosis and treatment. We aimed to systematically review previously reported phenotypes of atopic dermatitis and any characteristics associated with them. Ovid EMBASE, Ovid MEDLINE and Web of Science were searched from inception till 12 February 2021 for studies attempting to classify atopic dermatitis. Primary outcomes are atopic dermatitis phenotypes and characteristics associated with them in subsequent analyses. A secondary outcome is the methodological approach used to derive them. In total, 8511 records were found. By focussing only on certain clinical phenotypes, 186 studies were eligible for inclusion. The majority of studies were hospital-based (59%, 109/186) and cross-sectional (76%, 141/186). The number of included patients ranged from seven to 526 808. Data-driven approaches to identify phenotypes were only used in a minority of studies (7%, 13/186). Ninety-one studies (49%) investigated a phenotype based on disease severity. A phenotype based on disease trajectory, morphology and eczema herpeticum was investigated in 56 (30%), 22 (12%) and 11 (6%) studies respectively. Thirty-six studies (19%) investigated morphological characteristics in other phenotypes. Investigated associated characteristics differed between studies. In conclusion, we present an overview of phenotype definitions used in literature for severity, trajectory, morphology and eczema herpeticum, including associated characteristics. There is a lack of uniform and consistent use of atopic dermatitis phenotypes across studies., (© 2022 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)
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- 2022
- Full Text
- View/download PDF
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