24 results on '"Thorlacius, L."'
Search Results
2. The Hidradenitis Suppurativa Quality of Life (HiSQOL) score: development and validation of a measure for clinical trials
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Kirby, J.S., primary, Thorlacius, L., additional, Villumsen, B., additional, Ingram, J.R., additional, Garg, A., additional, Christensen, K.B., additional, Butt, M., additional, Esmann, S., additional, Tan, J., additional, and Jemec, G.B.E., additional
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- 2019
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3. Validation of global item for assessing impact on quality of life of patients with hidradenitis suppurativa.
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Kirby, J.S., Hereford, B., Thorlacius, L., Villumsen, B., Ingram, J.R., Garg, A., Butt, M., Esmann, S., King, T., Tan, J., and Jemec, G.B.E.
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HIDRADENITIS suppurativa ,QUALITY of life ,INTRACLASS correlation ,COGNITIVE interviewing ,STATISTICAL reliability - Abstract
Background: Hidradenitis suppurativa (HS) is a chronic inflammatory disease. The HS core outcome set calls for a patient global assessment (PtGA). Objectives: To assess the validity, reliability and responsiveness of a candidate single‐item PtGA for HS‐specific health‐related quality of life (HRQoL). Methods: Cognitive debriefing interviews were conducted with patients with HS in Denmark and the USA. A cross‐sectional observational study was done with adults with HS in the USA and Denmark. Candidate PtGA item, demographic items and multiple patient‐reported scales – the Hidradenitis Suppurativa Quality of Life (HiSQOL), Dermatology Life Quality Index (DLQI) and numerical rating scale (NRS) for pain – were concurrently administered to evaluate convergent and known‐groups validity. Scales with a single‐item assessment of change were readministered 24–72 h later, to evaluate reliability and responsiveness. Results: After cognitive debriefing, the candidate PtGA for HS‐specific HRQoL was finalized with five response levels. Convergent validity of the PtGA was supported by significant correlations with HiSQOL score [r = 0·79, 95% confidence interval (CI) 0·75–0·82] and DLQI (r = 0·78, 95% CI 0·74–0·82). The PtGA displayed known‐groups validity with DLQI score bands based on significance of an anova (P < 0·001). Good test–retest reliability was supported by the intraclass correlation coefficient (0·82, 95% CI 0·78–0·85) for those who reported stable HS. Responsiveness was assessed by differences in PtGA score against a patient‐reported assessment of change, which showed significant differences towards improvement. Conclusions: The single‐item PtGA exhibits reliability, validity and responsiveness in assessing HS‐specific HRQoL in HS, making it a good provisional tool for HS clinical research. What is already known about this topic? Hidradenitis suppurativa (HS) can have a large negative impact on health‐related quality of life (HRQoL).Patient global assessments are useful in eliciting important aspects of the patient's perspective on an individual basis.Few studies have developed and investigated the measurement properties of a patient global assessment (PtGA) item for HS. What does this study add? This study describes the development, validation and psychometric properties of a PtGA item for HS.This PtGA item for HRQoL shows promise with its validity and reliability, allowing for its further development as a clinical research tool. What are the clinical implications of this work? The PtGA item can now be investigated longitudinally in a treated population to further elucidate the responsiveness, minimally important change and score bands. [ABSTRACT FROM AUTHOR]
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- 2021
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4. Inter‐rater reliability and agreement hidradenitis suppurativa instruments
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Thorlacius, L., primary, Garg, A., additional, Riis, P.T., additional, Nielsen, S.M., additional, Bettoli, V., additional, Ingram, J.R., additional, Marmol, V., additional, Matusiak, L., additional, Pascual, J.C., additional, Revuz, J., additional, Sartorius, K., additional, Tzellos, T., additional, Zee, H.H., additional, Zouboulis, C.C., additional, Saunte, D.M., additional, Gottlieb, A.B., additional, Christensen, R., additional, and Jemec, G.B.E., additional
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- 2019
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5. 化脓性汗腺炎量表的评定者间可靠性和一致性
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Thorlacius, L., primary, Garg, A., additional, Riis, P.T., additional, Nielsen, S.M., additional, Bettoli, V., additional, Ingram, J.R., additional, Marmol, V., additional, Matusiak, L., additional, Pascual, J.C., additional, Revuz, J., additional, Sartorius, K., additional, Tzellos, T., additional, Zee, H.H., additional, Zouboulis, C.C., additional, Saunte, D.M., additional, Gottlieb, A.B., additional, Christensen, R., additional, and Jemec, G.B.E., additional
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- 2019
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6. Severity staging of hidradenitis suppurativa: is Hurley classification the answer?
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Thorlacius, L., primary
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- 2019
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7. Inter‐rater agreement and reliability of outcome measurement instruments and staging systems used in hidradenitis suppurativa
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Thorlacius, L., primary, Garg, A., additional, Riis, P.T., additional, Nielsen, S.M., additional, Bettoli, V., additional, Ingram, J.R., additional, Marmol, V., additional, Matusiak, L., additional, Pascual, J.C., additional, Revuz, J., additional, Sartorius, K., additional, Tzellos, T., additional, Zee, H.H., additional, Zouboulis, C.C., additional, Saunte, D.M., additional, Gottlieb, A.B., additional, Christensen, R., additional, and Jemec, G.B.E., additional
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- 2019
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8. The Hidradenitis Suppurativa Quality of Life (HiSQOL) score: development and validation of a measure for clinical trials.
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Kirby, J.S., Thorlacius, L., Villumsen, B., Ingram, J.R., Garg, A., Christensen, K.B., Butt, M., Esmann, S., Tan, J., and Jemec, G.B.E.
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HIDRADENITIS suppurativa , *CLINICAL trials , *QUALITY of life , *MEASURING instruments , *COGNITIVE interviewing - Abstract
Summary: Background: Hidradenitis suppurativa (HS) is a chronic, inflammatory condition that can have a large negative impact on health‐related quality of life (HRQOL). A reliable and validated measure of HS‐specific HRQOL in clinical studies is needed. Objectives: To develop and validate the Hidradenitis Suppurativa Quality Of Life (HiSQOL©) scale, for clinical trial measurement of HS‐specific HRQOL. Methods: In stage 1, qualitative concept elicitation interviews were conducted with patients with HS in Denmark (n = 21) and the U.S.A. (n = 21). In stage 2, cognitive debriefing interviews were performed with U.S. (n = 30) and Danish patients with HS (n = 30). In stage 3 an observational study of 222 patients with HS in the U.S.A. was conducted for item reduction, measure validation and assessment of psychometric properties. In stage 4, an observational study of 215 patients with HS in Denmark was conducted to confirm the psychometric structure derived in stage 3. In both studies the Dermatology Life Quality Index, Hospital Anxiety and Depression Scale and numerical rating scale for pain were also included. Results: In concept elicitation, 99 items were generated, which were reduced to 41 after removing duplicates. In cognitive debriefing, two items were added and one item removed. A 42‐item instrument was psychometrically assessed. Based on psychometric analyses and patient input, the instrument was reduced to 17 items that had strong psychometric properties in both the U.S. and Danish samples. Conclusions: The HiSQOL is a reliable and valid instrument to measure HS‐specific HRQOL in clinical trials. What's already known about this topic? Hidradenitis suppurativa (HS) is a chronic, relapsing inflammatory skin condition with potential adverse impacts on health‐related quality of life (HRQOL).The ability to assess HS‐specific HRQOL is important to those with HS and in further research to mitigate the effects of the condition.Development of HS‐specific instruments is feasible, and existing instruments have limitations. What does this study add? This study describes the development, validation and psychometric properties of the HiSQOL, a novel HS‐specific HRQOL instrument.HiSQOL is a patient‐reported outcome measure developed for clinical trials to address disease‐specific changes in HRQOL. What are the clinical implications of this work? HiSQOL is acceptable and comprehensible, and has strong evidence for validity and reliability in assessing patient‐centred outcomes in clinical trials. [ABSTRACT FROM AUTHOR]
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- 2020
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9. 苏金单抗治疗化脓性汗腺炎
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Thorlacius, L., primary, Theut Riis, P., additional, and Jemec, G.B.E., additional
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- 2018
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10. Hidradenitis suppurativa treated with secukinumab
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Thorlacius, L., primary, Theut Riis, P., additional, and Jemec, G.B.E., additional
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- 2018
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11. Severe hidradenitis suppurativa responding to treatment with secukinumab: a case report
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Thorlacius, L., primary, Theut Riis, P., additional, and Jemec, G.B.E., additional
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- 2018
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12. 化脓性汗腺炎研究的核心结果的全球共识:历史性共识会议I和II的更新
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Thorlacius, L., primary, Garg, A., additional, Ingram, J.R., additional, Villumsen, B., additional, Theut Rii, P., additional, Gottlieb, A.B., additional, Merola, J.F., additional, Dellavalle, R., additional, Ardon, C., additional, Baba, R., additional, Bechara, F.G., additional, Cohen, A.D., additional, Daham, N., additional, Davis, M., additional, Emtestam, L., additional, Fernández-Peñas, P., additional, Filippelli, M., additional, Gibbons, A., additional, Grant, T., additional, Guilbault, S., additional, Gulliver, S., additional, Harris, C, additional, Harvent, C., additional, Houston, K., additional, Kirby, J.S., additional, Matusiak, L., additional, Mehdizadeh, A., additional, Mojica, T., additional, Okun, M., additional, Orgill, D., additional, Pallack, L., additional, Parks-Miller, A., additional, Prens, E.P., additional, Randell, S., additional, Rogers, C., additional, Rosen, C.F., additional, Choon, S.E., additional, van der Zee, H.H., additional, Christensen, R., additional, and Jemec, G.B.E., additional
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- 2018
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13. Towards global consensus on core outcomes for hidradenitis suppurativa research: an update from the HISTORIC consensus meetings I and II
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Thorlacius, L., primary, Garg, A., additional, Ingram, J.R., additional, Villumsen, B., additional, Theut Rii, P., additional, Gottlieb, A.B., additional, Merola, J.F., additional, Dellavalle, R., additional, Ardon, C., additional, Baba, R., additional, Bechara, F.G., additional, Cohen, A.D., additional, Daham, N., additional, Davis, M., additional, Emtestam, L., additional, Fernández-Peñas, P., additional, Filippelli, M., additional, Gibbons, A., additional, Grant, T., additional, Guilbault, S., additional, Gulliver, S., additional, Harris, C., additional, Harvent, C., additional, Houston, K., additional, Kirby, J.S., additional, Matusiak, L., additional, Mehdizadeh, A., additional, Mojica, T., additional, Okun, M., additional, Orgill, D., additional, Pallack, L., additional, Parks-Miller, A., additional, Prens, E.P., additional, Randell, S., additional, Rogers, C., additional, Rosen, C.F., additional, Choon, S.E., additional, van der Zee, H.H., additional, Christensen, R., additional, and Jemec, G.B.E., additional
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- 2018
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14. A pilot study of unemployment in patients with hidradenitis suppurativa in Denmark
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Theut Riis, P., primary, Thorlacius, L., additional, Knudsen List, E., additional, and Jemec, G.B.E., additional
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- 2017
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15. A core domain set for hidradenitis suppurativa trial outcomes: an international Delphi process.
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Thorlacius, L., Ingram, J. R., Villumsen, B., Esmann, S., Kirby, J. S., Gottlieb, A. B., Merola, J. F., Dellavalle, R., Nielsen, S. M., Christensen, R., Garg, A., Jemec, G. B. E., and on behalf of the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC)
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HIDRADENITIS suppurativa , *SKIN disease treatment , *MEDICAL personnel , *QUALITY of life , *DISEASE prevalence - Abstract
Summary: Background: There is no consensus on core outcome domains for hidradenitis suppurativa (HS). Heterogeneous outcome measure instruments in clinical trials likely leads to outcome‐reporting bias and limits the ability to synthesize evidence. Objectives: To achieve global multistakeholder consensus on a core outcome set (COS) of domains regarding what to measure in clinical trials for HS. Methods: Six stakeholder groups participated in a Delphi process that included five anonymous e‐Delphi rounds and four face‐to‐face consensus meetings to reach consensus on the final COS. The aim was for a 1 : 1 ratio of patients to healthcare professionals (HCPs). Results: A total of 41 patients and 52 HCPs from 19 countries in four continents participated in the consensus process, which yielded a final COS that included five domains: pain, physical signs, HS‐specific quality of life, global assessment and progression of course. A sixth domain, symptoms, was highly supported by patients and not by HCPs but is recommended for the core domain set. Conclusions: Routine adoption of the COS in future HS trials should ensure that core outcomes of importance to both patients and HCPs are collected. [ABSTRACT FROM AUTHOR]
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- 2018
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16. Core outcome sets in dermatology: report from the second meeting of the International Cochrane Skin Group Core Outcome Set Initiative.
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Kottner, J., Jacobi, L., Hahnel, E., Alam, M., Balzer, K., Beeckman, D., Busard, C., Chalmers, J., Deckert, S., Eleftheriadou, V., Furlan, K., Horbach, S. E. R., Kirkham, J., Nast, A., Spuls, P., Thiboutot, D., Thorlacius, L., Weller, K., Williams, H. C., and Schmitt, J.
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DERMATOLOGY ,CLINICAL trials ,DERMATOLOGISTS ,SKIN diseases ,MEDICAL research - Abstract
Summary: Results of clinical trials are the most important information source for generating external clinical evidence. The use of different outcomes across trials, which investigate similar interventions for similar patient groups, significantly limits the interpretation, comparability and clinical application of trial results. Core outcome sets (COSs) aim to overcome this limitation. A COS is an agreed standardized collection of outcomes that should be measured and reported in all clinical trials for a specific clinical condition. The Core Outcome Set Initiative within the Cochrane Skin Group (CSG‐COUSIN) supports the development of core outcomes in dermatology. In the second CSG‐COUSIN meeting held in 2017, 11 COS development groups working on skin diseases presented their current work. The presentations and discussions identified the following overarching methodological challenges for COS development in dermatology: it is not always easy to define the disease focus of a COS; the optimal method for outcome domain identification and level of detail needed to specify such domains is challenging to many; decision rules within Delphi surveys need to be improved; appropriate ways of patient involvement are not always clear. In addition, there appear to be outcome domains that may be relevant as potential core outcome domains for the majority of skin diseases. The close collaboration between methodologists in the Core Outcome Set Initiative and the international Cochrane Skin Group has major advantages for trialists, systematic reviewers and COS developers. [ABSTRACT FROM AUTHOR]
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- 2018
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17. Core domain set for hidradenitis suppurativa trial outcomes.
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Thorlacius, L., Ingram, J. R., Villumsen, B., Esmann, S., Kirby, J. S., Gottlieb, A. B., Merola, J. F., Dellavalle, R., Nielsen, S. M., Christensen, R., Garg, A., Jemec, G. B. E., and the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC)
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HIDRADENITIS suppurativa , *SKIN disease treatment , *QUALITY of life , *PHARMACEUTICAL industry , *DERMATOLOGY , *THERAPEUTICS - Abstract
Summary: Hidradenitis suppurativa (HS) is a skin condition that causes painful swollen red bumps in the folds of the body (underarms, under breasts, groin, and buttocks). It can be mistaken for bacterial abscess or boils, but HS is not caused by bacteria. HS occurs in about 0.1% to 4% of people worldwide. This study aimed to find out what clinical trials for HS should measure, such as symptoms (e.g. pain, itch), physical changes (e.g. skin redness or swelling), or impact on people's lives (e.g. quality of life). To do this, the study included two groups: people with HS and healthcare providers (physicians, pharmaceutical industry representatives, and regulatory representatives) and conducted online surveys and in‐person meetings with presentations and discussions as well as surveys to gather opinions on which measures to include. Thirteen countries and four continents were represented. The result of the meetings, discussions, and surveys showed that at least 70% of the people with HS and healthcare providers recommended that clinical trials include measures of: (1) pain (2) physical changes due to HS (e.g. redness); (3) quality of life changes due to HS specifically; (4) changes in the course of HS (e.g. flare‐ups) (5) global rating (i.e. overall rating, considering everything, of the severity of the condition) and (6) other symptoms (fatigue and drainage). This work is important because it included many different types of people who contribute to HS treatment, including the people who have HS, develop or regulate treatments, and treat people with HS. More work is coming and it will focus on how to measure in trials treating HS (what instruments to use). [ABSTRACT FROM AUTHOR]
- Published
- 2018
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18. 皮肤医学的核心结果集合:来自国际Cochrane皮肤小组核心结果集合倡议的报告.
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Kottner, J., Jacobi, L., Hahnel, E., Alam, M., Balzer, K., Beeckman, D., Busard, C., Chalmers, J., Deckert, S., Eleftheriadou, V., Furlan, K., Horbach, S. E. R., Kirkham, J., Nast, A., Spuls, Ph., Thiboutot, D., Thorlacius, L., Weller, K., Williams, H. C., and Schmitt, J.
- Abstract
Copyright of British Journal of Dermatology is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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- 2018
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19. Global consensus process to establish a core dataset for hidradenitis suppurativa registries.
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Wainman HE, Chandran NS, Frew JW, Garg A, Gibbons A, Gierbolini A, Horvath B, Jemec GB, Kirby B, Kirby J, Lowes MA, Martorell A, McGrath BM, Naik HB, Oon HH, Prens E, Sayed CJ, Thorlacius L, Van der Zee HH, Villumsen B, and Ingram JR
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- Humans, Consensus, Treatment Outcome, Delphi Technique, Registries, Hidradenitis Suppurativa diagnosis, Hidradenitis Suppurativa epidemiology, Hidradenitis Suppurativa therapy
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Background: Several registries for hidradenitis suppurativa (HS) already exist in Europe and the USA. There is currently no global consensus on a core dataset (CDS) for these registries. Creating a global HS registry is challenging, owing to logistical and regulatory constraints, which could limit opportunities for global collaboration as a result of differences in the dataset collected. The solution is to encourage all HS registries to collect the same CDS of information, allowing registries to collaborate., Objectives: To establish a core set of items to be collected by all HS registries globally. The core set will cover demographic details, comorbidities, clinical examination findings, patient-reported outcome measures and treatments., Methods: Beginning in September 2022, 20 participants - including both clinicians with expertise in HS and patient advocates - from eight countries across three continents participated in a Delphi process consisting of four rounds of voting, with all participants completing each round. A list of potential items for inclusion in the core set was generated from the relevant published literature, including systematic reviews of comorbidities in HS, clinical and examination findings, and epidemiology. For disease severity and progression items, the Hidradenitis SuppuraTiva Core outcome set International Collaboration (HiSTORIC) core set and other relevant instruments were considered for inclusion. This resulted in 47 initial items. Participants were invited to suggest additional items to include during the first round. Anonymous feedback was provided to inform each subsequent round of voting to encourage consensus., Results: The eDelphi process established a CDS of 48 items recommended for inclusion in all HS registries globally., Conclusions: The routine adoption of this CDS in current and future HS registries should allow registries in different parts of the world to collaborate, enabling research requiring large numbers of participants., (© The Author(s) 2023. Published by Oxford University Press on behalf of British Association of Dermatologists. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2024
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20. Severity rating of specific skin lesions in hidradenitis suppurativa: the ptient perspective.
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Thorlacius L, Riis PT, Musaeus KD, Saunte DM, Esmann S, Jemec GBE, and Hansen ST
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- Humans, Severity of Illness Index, Hidradenitis Suppurativa diagnosis, Hidradenitis Suppurativa pathology
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- 2024
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21. Factors associated with disease-specific life impact in patients with hidradenitis suppurativa: results from the Global VOICE project.
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Garg A, Rawal S, Akilov O, Alavi A, Ardon C, Bechara FG, Cohen AD, Cohen SR, Daveluy S, Del Marmol V, Delage M, Esmann S, Fisher S, Giamarellos-Bourboulis EJ, Glowaczewska A, Goldfarb N, Brant EG, Grimstad Ø, Guilbault S, Hamzavi I, Hughes R, Ingram JR, Jemec GBE, Ju Q, Kappe N, Kirby B, Kirby JS, Lowes MA, Matusiak L, Micha S, Micheletti RG, Miller AP, Moseng D, Naik HB, Nassif A, Nikolakis G, Paek SY, Pascual JC, Prens E, Resnik B, Riad H, Sayed C, Smith SD, Soliman Y, Szepietowski JC, Tan J, Thorlacius L, Tzellos T, van der Zee HH, Villumsen B, Wang L, Zouboulis CC, and Strunk A
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- Humans, Quality of Life, Hidradenitis Suppurativa complications
- Abstract
Competing Interests: Conflicts of interest A list of conflicts of interest can be found in Appendix S1 (see Supporting Information).
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- 2023
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22. A milestone reached in the standardization of lichen sclerosus trial outcomes.
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Thorlacius L and Alam M
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- Humans, Female, Tacrolimus, Reference Standards, Outcome Assessment, Health Care, Lichen Sclerosus et Atrophicus, Vulvar Lichen Sclerosus
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Competing Interests: Conflicts of interest L.T. and M.A. are C3 Board and Methods Group members.
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- 2023
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23. Factors associated with treatment satisfaction in patients with hidradenitis suppurativa: results from the Global VOICE project.
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Midgette B, Strunk A, Akilov O, Alavi A, Ardon C, Bechara FG, Cohen AD, Cohen S, Daveluy S, Del Marmol V, Delage M, Esmann S, Fisher S, Giamarellos-Bourboulis EJ, Glowaczewska A, Goldfarb N, Brant EG, Grimstad Ø, Guilbault S, Hamzavi I, Hughes R, Ingram JR, Jemec GBE, Ju Q, Kappe N, Kirby B, Kirby JS, Lowes MA, Matusiak L, Micha S, Micheletti R, Miller AP, Moseng D, Naik H, Nassif A, Nikolakis G, Paek SY, Pascual JC, Prens E, Resnik B, Riad H, Sayed C, Smith SD, Soliman Y, Szepietowski JC, Tan J, Thorlacius L, Tzellos T, van der Zee HH, Villumsen B, Wang L, Zouboulis C, and Garg A
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- Humans, Female, Cross-Sectional Studies, Personal Satisfaction, Patient Satisfaction, Hidradenitis Suppurativa drug therapy, Hidradenitis Suppurativa complications, Biological Products therapeutic use
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Background: Nearly half of patients with hidradenitis suppurativa (HS) report dissatisfaction with their treatment. However, factors related to treatment satisfaction have not been explored., Objectives: To measure associations between treatment satisfaction and clinical and treatment-related characteristics among patients with HS., Methods: Treatment satisfaction was evaluated utilizing data from a cross-sectional global survey of patients with HS recruited from 27 institutions, mainly HS referral centres, in 14 different countries from October 2017 to July 2018. The primary outcome was patients' self-reported overall satisfaction with their current treatments for HS, rated on a five-point scale from 'very dissatisfied' to 'very satisfied'., Results: The final analysis cohort comprised 1418 patients with HS, most of whom were European (55%, 780 of 1418) or North American (38%, 542 of 1418), and female (85%, 1210 of 1418). Overall, 45% (640 of 1418) of participants were either dissatisfied or very dissatisfied with their current medical treatment. In adjusted analysis, patients primarily treated by a dermatologist for HS had 1·99 [95% confidence interval (CI) 1·62-2·44, P < 0·001] times the odds of being satisfied with current treatment than participants not primarily treated by a dermatologist. Treatment with biologics was associated with higher satisfaction [odds ratio (OR) 2·36, 95% CI 1·74-3·19, P < 0·001] relative to treatment with nonbiologic systemic medications. Factors associated with lower treatment satisfaction included smoking (OR 0·78, 95% CI 0·62-0·99; active vs. never), depression (OR 0·69, 95% CI 0·54-0·87), increasing number of comorbidities (OR 0·88 per comorbidity, 95% CI 0·81-0·96) and increasing flare frequency., Conclusions: There are several factors that appear to positively influence satisfaction with treatment among patients with HS, including treatment by a dermatologist and treatment with a biologic medication. Factors that appear to lower treatment satisfaction include active smoking, depression, accumulation of comorbid conditions and increasing flare frequency. Awareness of these factors may support partnered decision making with the goal of improving treatment outcomes. What is already known about this topic? Nearly half of patients with hidradenitis suppurativa report dissatisfaction with their treatments. What does this study add? Satisfaction with treatment is increased by receiving care from a dermatologist and treatment with biologics. Satisfaction with treatment is decreased by tobacco smoking, accumulation of comorbid conditions including depression, and higher flare frequency. What are the clinical implications of this work? Awareness of the identified factors associated with poor treatment satisfaction may support partnered decision making and improve treatment outcomes., (© 2022 British Association of Dermatologists.)
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- 2022
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24. Development and initial validation of the HS-IGA: a novel hidradenitis suppurativa-specific investigator global assessment for use in interventional trials.
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Garg A, Zema C, Kim K, Gao W, Chen N, Jemec GBE, Kirby J, Thorlacius L, Villumsen B, and Ingram JR
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- Humans, Clinical Trials, Phase III as Topic, Immunoglobulin A, Quality of Life, Randomized Controlled Trials as Topic, Reproducibility of Results, Severity of Illness Index, Hidradenitis Suppurativa drug therapy, Hidradenitis Suppurativa therapy
- Abstract
Background: Few validated instruments exist for use in hidradenitis suppurativa (HS) trials., Objectives: To develop a novel HS Investigator Global Assessment (HS-IGA) and to validate its psychometric properties., Methods: Development of HS-IGA involved discussion among stakeholders, including patients, within HISTORIC. Data from replicate phase III randomized controlled trials evaluating HS treatment were utilized. Multivariate models identified lesion type and body region as variables of importance. Classification and regression trees for ordinal responses were built. Validation included assessment of test-retest reliability, predictive validity, responsiveness and clinical meaningfulness., Results: There were 3024 unique measurements available in PIONEER I. Mean and median lesion counts by region were largely <10 and were highest in axillary and inguinal regions. The mean and median number of regions involved were ≤ 3 for individual lesions and combinations. Regardless of lesion type, axillary and inguinal regions most influenced the HS-IGA score. Accordingly, regions were combined into a six-point IGA based on the maximum lesion number in either upper or lower body regions with a score of 0 (0-1 lesions), 1 (2-5), 2 (6-10), 3 (11-15), 4 (16-20) and 5 (≥ 20 lesions). The intraclass correlation coefficient for test-retest reliability was 0·91 (95% confidence interval 0·87-0·94). Spearman's rank order correlations (SROCs) with HS-PGA and Hidradenitis Suppurativa Clinical Response (HiSCR) were 0·73 and 0·51, respectively (P < 0·001 for both comparisons). SROCs with Dermatology Life Quality Index (DLQI), pain numerical rating scale and HS-QoL were 0·42, 0·34 and -0·25, respectively (P < 0·001 for all comparisons). HS-IGA was responsive at weeks 12 and 36. Predictive convergent validity was very good with HS-PGA (area under the curve = 0·89) and with HiSCR (area under the curve = 0·82). Predictive divergent validity was low with DLQI and HS-QoL., Conclusions: HS-IGA has moderate-to-strong psychometric properties and is simple to calculate., (© 2022 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.)
- Published
- 2022
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