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The Harmonizing Outcome Measures for Eczema (HOME) Roadmap: A Methodological Framework to Develop Core Sets of Outcome Measurements in Dermatology
Open accessAbstract
Core outcome sets (COSs) are consensus-derived minimum sets of outcomes to be assessed in a specific situation. COSs are being increasingly developed to limit outcome-reporting bias, allow comparisons across trials, and strengthen clinical decision making. Despite the increasing interest in outcomes research, methods to develop COSs have not yet been standardized. The aim of this paper is to present the Harmonizing Outcomes Measures for Eczema (HOME) roadmap for the development and implementation of COSs, which was developed on the basis of our experience in the standardization of outcome measurements for atopic eczema. Following the establishment of a panel representing all relevant stakeholders and a research team experienced in outcomes research, the scope and setting of the core set should be defined. The next steps are the definition of a core set of outcome domains such as symptoms or quality of life, followed by the identification or development and validation of appropriate outcome measurement instruments to measure these core domains. Finally, the consented COS needs to be disseminated, implemented, and reviewed. We believe that the HOME roadmap is a useful methodological framework to develop COSs in dermatology, with the ultimate goal of better decision making and promoting patient-centered health care.
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“In accordance with the HOME roadmap (7), we set out to perform a systematic review of the measurement properties of all instruments that were developed and validated to measure QoL in eczema patients.”
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“20 Serious adverse events were more commonly noted in the placebo groups, including skin infections and exacerbation of AD.”
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“To adequately 55 capture the domain of interest, measurement instruments need to be valid, reliable, and sensitive to 56 change [17, 18].”
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Chovatiya, R., & Silverberg, J. I. (2022) · American Journal of Clinical Dermatology · doi:10.1007/s40257-022-00697-w · Cited by 30
Validation of Treatment Escalation as a Definition of Atopic Eczema Flares
Thomas, K. S., Stuart, B. L., O’Leary, C., Schmitt, J. M., Paul, C. F., Williams, H. C., & Langan, S. (2015) · PLoS ONE · doi:10.1371/journal.pone.0124770 · Cited by 30
“The HOME initiative has adopted the Outcome Measures in Rheumatology (OMERACT) filter[17] for the assessment of potential outcome measure for inclusion in the recommended core outcome set [12,18].”
MethodSelf-citationNakamura, T., Haider, S., Colicino, S., Murray, C. S., Holloway, J. W., Simpson, A., Cullinan, P., Čustović, A., & the STELAR investigators (2019) · British Journal of Dermatology · doi:10.1111/bjd.17853 · Cited by 29
Heinl, D., Prinsen, C. A. C., Drucker, A. M., Ofenloch, R. F., Humphreys, R., Sach, T., Flohr, C., & Apfelbacher, C. (2016) · Systematic Reviews · doi:10.1186/s13643-016-0202-z · Cited by 30
“The next crucial step in the process of standardizing eczema outcome measurements is now the identification of appropriate instruments to measure each of the four core outcome domains of atopic eczema [11].”
BackgroundSelf-citationBidirectional relationships between psychological health and dermatological conditions in children
Mitchell, A. E. (2018) · Psychology Research and Behavior Management · doi:10.2147/prbm.s117583 · Cited by 29
“Quality-of-life measures are being targeted in the drive to establish sets of core outcome measures to be used in the evaluation of pharmacological and psychosocial treatments and interventions for individuals with dermatological conditions.(80) As previously outlined, children with chronic skin disease suffer similar…”
BackgroundSmith, E., Patel, M., & Thomas, K. S. (2017) · British Journal of Dermatology · doi:10.1111/bjd.16235 · Cited by 28
Self-citationScratching damages tight junctions through the Akt–claudin 1 axis in atopic dermatitis
Hu, X., Tang, Y., Ju, Y., Zhang, X. Y., Yan, J.-Y., Wang, C., Yang, Y., Zhu, C., Tang, Z., Zhou, Y., et al. (2020) · Clinical and Experimental Dermatology · doi:10.1111/ced.14380 · Cited by 28
Chinese herbal medicine for atopic eczema: an overview of clinical evidence
Gu, S., Zhang, A. L., Coyle, M., Chen, D., & Xue, C. C. (2016) · Journal of Dermatological Treatment · doi:10.1080/09546634.2016.1214673 · Cited by 27
“Each of the CODs should be measured by a core outcome measurement instrument (COMI) (41).”
MethodInfluentialLong-Term Treatment of Atopic Dermatitis
Prezzano, J. C., & Beck, L. A. (2017) · Dermatologic Clinics · doi:10.1016/j.det.2017.02.007 · Cited by 27
The Harmonising Outcome Measures for Eczema (HOME) implementation roadmap
Leshem, Y. A., Simpson, E. L., Apfelbacher, C., Spuls, P. I., Thomas, K. S., Schmitt, J. M., Howells, L., Gerbens, L. A. A., Jacobson, M. E., Katoh, N., et al. (2023) · British Journal of Dermatology · doi:10.1093/bjd/ljad278 · Cited by 24
Self-citationCore outcome domains for lichen sclerosus: a CORALS initiative consensus statement
Simpson, R. C., Kirtschig, G., Selk, A., von Seitzberg, S., Vittrup, G., Bissonnette, I., Kottner, J., Lanthier, J., Stanton, C., Foster, D., et al. (2023) · British Journal of Dermatology · doi:10.1093/bjd/ljac145 · Cited by 24
Self-citationLokhorst, M. M., Horbach, S. E. R., Waner, M., T.M., O., van der Vleuten, C. J. M., Mokkink, L. B., van der Horst, C. M. A. M., & Spuls, P. I. (2019) · British Journal of Dermatology · doi:10.1111/bjd.18619 · Cited by 23
Self-citationZidarov, D., Zidarova-Carrié, A., Visca, R., Miller, J., Brecht, K., Viens, N., & Ahmed, S. (2020) · Quality of Life Research · doi:10.1007/s11136-020-02459-9 · Cited by 21
Schlessinger, D. I., Iyengar, S., Yanes, A. F., Lazaroff, J. M., Godinez-Puig, V., Chen, B. R., Kurta, A. O., Henley, J. K., Chiren, S. G., Furlan, K. C., et al. (2017) · Trials · doi:10.1186/s13063-017-2244-5 · Cited by 21
“Methods/design The development of this COS adheres to the recommendations provided by the COMET and CSG-COUSIN initiatives, with reporting conforming to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Checklist [13, 21].”
BackgroundMethodSelf-citationKaiser, U., Neustadt, K., Kopkow, C., Schmitt, J. M., & Sabatowski, R. (2016) · Healthcare · doi:10.3390/healthcare4030063 · Cited by 21
“[8] developing COSs consists of several different steps, frequently beginning with a systematic review of all outcomes reported in clinical trials and a subsequent consensus process to vote for relevant outcome domains which should be assessed in clinical trials.”
BackgroundMethodInfluentialSelf-citationDrucker, A. M., Ellis, A. G., Jabbar‐Lopez, Z. K., Yiu, Z. Z. N., Arents, B. W. M., Burton, T., Spuls, P. I., Küster, D., Schmitt, J. M., & Flohr, C. (2018) · BMJ Open · doi:10.1136/bmjopen-2018-023061 · Cited by 21
“To date, no NMA has been conducted comparing systemic treatments for AD.”
BackgroundMethodInfluentialSelf-citationvan Geel, N., Wolkerstorfer, A., Ezzedine, K., Pandya, A. G., Bekkenk, M. W., Grine, L., Belle, S. V., Lommerts, J. E., Hamzavi, I. H., Harris, J. E., et al. (2019) · Pigment Cell & Melanoma Research · doi:10.1111/pcmr.12784 · Cited by 20
“…of interpretability was highlighted by Schmitt et al. in the Harmonizing Outcome Measures for Eczema (HOME) roadmap for the development and implementa‐ tion of core outcome sets (COS), currently recognized as a standard‐ ized methodology to develop COSs in dermatology (Schmitt et al., 2015).”
MethodOutcomes for clinical trials of food allergy treatments
Sim, K., Mijakoski, D., Stoleski, S., del Río, P. R., Sammut, P., Le, T., Munblit, D., & Boyle, R. J. (2020) · Annals of Allergy Asthma & Immunology · doi:10.1016/j.anai.2020.06.023 · Cited by 20
Birkner, T., Siegels, D., Heinrich, L., Haufe, E., Abraham, S., Heratizadeh, A., Harder, I., Bell, M., Fell, I., Worm, M., et al. (2023) · JDDG Journal der Deutschen Dermatologischen Gesellschaft · doi:10.1111/ddg.15159 · Cited by 19
Self-citationEndpoints and Outcomes After Immunotherapy for Food Allergy: What Is Meaningful for Patients?
Lloyd, M., Patel, N., Munblit, D., & Tang, M. L. K. (2023) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2023.01.033 · Cited by 18
Arnold, K., Scheibe, M., Müller, O., & Schmitt, J. M. (2016) · Zeitschrift für Evidenz Fortbildung und Qualität im Gesundheitswesen · doi:10.1016/j.zefq.2016.04.011 · Cited by 18
Self-citationLange, T., Kottner, J., Weberschock, T. B., Hahnel, E., Apfelbacher, C., Brandstetter, S., Dreher, A., Datzmann, T., Burden‐Teh, E., Rogers, N. K., et al. (2020) · Journal of the European Academy of Dermatology and Venereology · doi:10.1111/jdv.16854 · Cited by 19
Self-citationWilkes, S. R., Nankervis, H., Tavernier, E., Maruani, A., & Williams, H. C. (2016) · Journal of Investigative Dermatology · doi:10.1016/j.jid.2016.05.104 · Cited by 18
“…studies, greater emphasis should be made on the choice of outcomes such as the core outcome set currently being developed by the Harmonising Outcomes in Eczema initiative so that studies can be compared directly against each other in systematic review meta-analyses (Schmitt et al., 2015).”
BackgroundSelf-citationDavies, B. M., Touzet, A. Y., Mowforth, O. D., Lee, K. S., Khan, D. Z., Furlan, J. C., Fehlings, M. G., Harrop, J. S., Zipser, C. M., Rodrigues‐Pinto, R., et al. (2022) · BMJ Open · doi:10.1136/bmjopen-2021-060436 · Cited by 17
Assessing effectiveness in acne clinical trials: steps towards a core outcome measure set
Thiboutot, D. M., Layton, A., Chren, M., Eady, E. A., & Tan, J. K. L. (2019) · British Journal of Dermatology · doi:10.1111/bjd.18011 · Cited by 17
Schlessinger, D. I., Iyengar, S., Yanes, A. F., Henley, J. K., Ashchyan, H. J., Kurta, A. O., Patel, P. M., Sheikh, U. A., Franklin, M. J., Hanna, C. C., et al. (2017) · Trials · doi:10.1186/s13063-017-2104-3 · Cited by 16
“CSGCOUSIN builds on the roadmap developed by the Harmonising Outcome Measures for Eczema (HOME) initiative for the process of COS development and implementation [13].”
BackgroundMethodInfluentialSelf-citationCore outcomes for pressure ulcer prevention trials: results of an international consensus study
Lechner, A., Coleman, S. B., Balzer, K., Kirkham, J. J., Muir, D., Nixon, J., & Kottner, J. (2022) · British Journal of Dermatology · doi:10.1111/bjd.21741 · Cited by 19
Lu, J. D., Hobbs, M. M., Huang, W. W.-T., Ortega‐Loayza, A. G., & Alavi, A. (2020) · British Journal of Dermatology · doi:10.1111/bjd.19027 · Cited by 16
Evidence-based practices in pressure ulcer prevention: Lost in implementation?
Balzer, K., & Kottner, J. (2015) · International Journal of Nursing Studies · doi:10.1016/j.ijnurstu.2015.08.006 · Cited by 16
Reporting of outcomes in randomized controlled trials on nail psoriasis: a systematic review
Busard, C. I., Nolte, J., Pasch, M. C., & Spuls, P. I. (2017) · British Journal of Dermatology · doi:10.1111/bjd.15831 · Cited by 15
Self-citationPotter, S., Davies, C. F., Holcombe, C., Weiler-Mithoff, E. M., Skillman, J. M., Vidya, R., Masannat, Y., Weber, W. P., Heil, J., Wilson, S. M., et al. (2020) · BMJ Open · doi:10.1136/bmjopen-2019-035505 · Cited by 15
Pierce, E. J., Boytsov, N. N., Vasey, J., Sudaria, T. C., Liu, X., Lavelle, K. W., Bogdanov, A., & Goldblum, O. M. (2021) · Dermatology and Therapy · doi:10.1007/s13555-021-00553-5 · Cited by 15
“This finding is in contrast to AD burden and QoL studies that show that skin pain is a common and often severe condition with variable frequency, intensity, and impact on QoL among patients with AD [16, 17].”
BackgroundInfluentialDevelopment of a core outcome set for traumatic brachial plexus injuries (COMBINE): study protocol
Miller, C., Cross, J., Power, D., Kyte, D. G., & Jerosch‐Herold, C. (2019) · BMJ Open · doi:10.1136/bmjopen-2019-030146 · Cited by 15
“Outcome domains like these have previously been used by other COS developers.(46) 47 Outcome domains will include physiological/clinical, function, global quality of life and adverse events.”
MethodMeasuring Signs of Atopic Dermatitis in Clinical Practice
Jacobson, M. E., Leshem, Y. A., Apfelbacher, C., Spuls, P. I., Gerbens, L. A. A., Thomas, K. S., Williams, H. C., Katoh, N., Howells, L., Schmitt, J. M., et al. (2024) · JAMA Dermatology · doi:10.1001/jamadermatol.2024.1162 · Cited by 16
Self-citationUsefulness of Rajka & Langeland Eczema Severity Score in Clinical Practice
Gånemo, A., Svensson, Å., Svedman, C., Grönberg, B., Johansson, A., & Wahlgren, C. (2016) · Acta Dermato Venereologica · doi:10.2340/00015555-2302 · Cited by 14
“No recommendations have yet been made for symptoms, long-term control and quality of life (28).”
Backgroundden Bussche, K. V., Meyer, D. D., Damme, N. V., Kottner, J., & Beeckman, D. (2016) · Journal of Advanced Nursing · doi:10.1111/jan.13165 · Cited by 14
T helper type 2 signatures in atopic dermatitis
Furue, M. (2018) · Journal of Cutaneous Immunology and Allergy · doi:10.1002/cia2.12023 · Cited by 14
Self-citationvan Geel, N., Hamzavi, I. H., Pandya, A. G., Wolkerstorfer, A., Sénéschal, J., Garg, A., Spuls, P. I., Terwee, C. B., Mallett, S., Speeckaert, R., et al. (2022) · Trials · doi:10.1186/s13063-022-06497-1 · Cited by 13
Self-citation
Metadata
- Authors
- Schmitt, J., Apfelbacher, C., Spuls, P. I., Thomas, K. S., Simpson, E. L., Furue, M., Chalmers, J., & Williams, H. C.
- Affiliations
- University Hospital Carl Gustav Carus (DE)
- University of Regensburg (DE)
- Amsterdam UMC Location University of Amsterdam (NL)
- University of Nottingham (GB)
- Oregon Health & Science University (US)
- Kyushu University (JP)
- Corresponding author
- Schmitt, Jochen
- ORCID
- Venue
- Journal of Investigative Dermatology
- Publisher
- Elsevier BV
- Published
- 2015-01
- Volume
- 135
- Issue
- 1
- Pages
- 24-30
- ISSN
- 0022-202X (ISSN-L)
- OpenAlex
- W2037799574
- Cited by
- 230
- References
- 29
- Citations by year
- 2026: 8 · 2025: 8 · 2024: 9 · 2023: 18 · 2022: 21 · 2021: 21 · 2020: 30 · 2019: 18 · 2018: 21 · 2017: 28 · 2016: 27 · 2015: 17
- FWCI
- 81.19
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of Investigative Dermatology (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Repository@Nottingham (University of Nottingham) (submittedVersion, cc-by)
- Repository@Nottingham (University of Nottingham) (submittedVersion)
- Funders
- National Institutes of Health (5K23AR057486)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases
- National Institute for Health Research (RP-PG-0407-10177)
- Topics
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Health Sciences › Medicine › Dermatology › Dermatology and Skin Diseases
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Keywords
- core outcome set, atopic dermatitis, outcome standardization, selective reporting, stakeholder consensus, outcome domains, quality of life, symptom assessment, patient-centered care
- MeSH terms
- Dermatology, Diffusion of Innovation, Eczema, Humans, Reproducibility of Results, Outcome Assessment, Health Care, Consensus
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