Development of an international core domain set for medium, large and giant congenital melanocytic naevi as a first step towards a core outcome set for clinical practice and research
Summary Background Medium, large and giant congenital melanocytic naevi (CMN) can impose a psychosocial burden on patients and families, and are associated with increased risk of developing melanoma or neurological symptoms. Lack of consensus on what outcomes to measure makes it difficult to advise...
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| Veröffentlicht in: | British journal of dermatology (1951) 2021-08, Vol.185 (2), p.371-379 |
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| container_title | British journal of dermatology (1951) |
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| creator | Oei, W. Fledderus, A.C. Spuls, P.I Eggen, C.A.M. Kottner, J. Horst, C.M.A.M. Wolkerstorfer, A. Kessel, M.S. Krengel, S. Etchevers, H.C. Korfage, I.J. Pasmans, S.G.M. |
| description | Summary
Background
Medium, large and giant congenital melanocytic naevi (CMN) can impose a psychosocial burden on patients and families, and are associated with increased risk of developing melanoma or neurological symptoms. Lack of consensus on what outcomes to measure makes it difficult to advise patients and families about treatment and to set up best practice for CMN.
Objectives
Fostering consensus among patient representatives and professionals, we aim to develop a core outcome set, defined as the minimum set of outcomes to measure and report in care and all clinical trials of a specific health condition. We focused on the ‘what to measure’ aspect, the so‐called core domain set (CDS), following the COMET and CS‐COUSIN guidelines.
Methods
We conducted a systematic review to identify outcomes reported in the literature. Focus groups with patient representatives identified patient‐reported outcomes. All these outcomes were classified into domains. Through e‐Delphi surveys, 144 stakeholders from 27 countries iteratively rated the importance of domains and outcomes. An online consensus meeting attended by seven patient representatives and seven professionals finalized the CDS.
Results
We reached consensus on six domains, four of which were applied to both care and research: ‘quality of life’, ‘neoplasms’, ‘nervous system’ and ‘anatomy of skin’. ‘Adverse events’ was specific to care and ‘pathology’ to research.
Conclusions
We have developed a CDS for medium‐to‐giant CMN. Its application in reporting care and research of CMN will facilitate treatment comparisons. The next step will be to reach consensus on the specific outcomes for each of the domains and what instruments should be used to measure these domains and outcomes.
What is already known about this topic?
Medium, large and giant congenital melanocytic naevi (CMN) are associated with psychosocial burden for patients and their families because of their unusual appearance and increased risk of melanoma and/or neurocutaneous melanocytosis.
Outcome reporting of treatment options for CMN is heterogeneous. Current lack of consensus in outcome reporting hinders the development of evidence‐based treatment guidelines for CMN.
Development of a core outcome set (COS) may enhance standardized reporting.
What does this study add?
We focus on the core domain set, the ‘what to measure’, for the COS.
By following the guidelines of COMET and CS‐COUSIN, we reached consensus on six domains.
Four of the domains were app |
| doi_str_mv | 10.1111/bjd.19694 |
| format | Article |
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Background
Medium, large and giant congenital melanocytic naevi (CMN) can impose a psychosocial burden on patients and families, and are associated with increased risk of developing melanoma or neurological symptoms. Lack of consensus on what outcomes to measure makes it difficult to advise patients and families about treatment and to set up best practice for CMN.
Objectives
Fostering consensus among patient representatives and professionals, we aim to develop a core outcome set, defined as the minimum set of outcomes to measure and report in care and all clinical trials of a specific health condition. We focused on the ‘what to measure’ aspect, the so‐called core domain set (CDS), following the COMET and CS‐COUSIN guidelines.
Methods
We conducted a systematic review to identify outcomes reported in the literature. Focus groups with patient representatives identified patient‐reported outcomes. All these outcomes were classified into domains. Through e‐Delphi surveys, 144 stakeholders from 27 countries iteratively rated the importance of domains and outcomes. An online consensus meeting attended by seven patient representatives and seven professionals finalized the CDS.
Results
We reached consensus on six domains, four of which were applied to both care and research: ‘quality of life’, ‘neoplasms’, ‘nervous system’ and ‘anatomy of skin’. ‘Adverse events’ was specific to care and ‘pathology’ to research.
Conclusions
We have developed a CDS for medium‐to‐giant CMN. Its application in reporting care and research of CMN will facilitate treatment comparisons. The next step will be to reach consensus on the specific outcomes for each of the domains and what instruments should be used to measure these domains and outcomes.
What is already known about this topic?
Medium, large and giant congenital melanocytic naevi (CMN) are associated with psychosocial burden for patients and their families because of their unusual appearance and increased risk of melanoma and/or neurocutaneous melanocytosis.
Outcome reporting of treatment options for CMN is heterogeneous. Current lack of consensus in outcome reporting hinders the development of evidence‐based treatment guidelines for CMN.
Development of a core outcome set (COS) may enhance standardized reporting.
What does this study add?
We focus on the core domain set, the ‘what to measure’, for the COS.
By following the guidelines of COMET and CS‐COUSIN, we reached consensus on six domains.
Four of the domains were applied to both care and research: ‘quality of life’, ‘neoplasms’, ‘nervous system’ and ‘anatomy of skin’. ‘Adverse events’ was specific to care and ‘pathology’ to research.
What are the clinical implications of this work?
Uptake of the core domain set in future clinical care of, and research about, medium‐to‐giant CMN should facilitate comparisons across different treatment choices for both patients and professionals.
Linked Comment: M.V. Heppt et al. Br J Dermatol 2021; 185:247–248.
Plain language summary available online</description><identifier>ISSN: 0007-0963</identifier><identifier>EISSN: 1365-2133</identifier><identifier>DOI: 10.1111/bjd.19694</identifier><identifier>PMID: 33237568</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Adverse events ; Cancer ; Clinical trials ; Human health and pathology ; Life Sciences ; Melanoma ; Nervous system ; Patients ; Quality of life</subject><ispartof>British journal of dermatology (1951), 2021-08, Vol.185 (2), p.371-379</ispartof><rights>2020 British Association of Dermatologists</rights><rights>2020 British Association of Dermatologists.</rights><rights>Copyright © 2021 British Association of Dermatologists</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4224-8e3eae2b3666ddced0c344b4f7b7867f81ae7d7eef2333b84193db55575891803</citedby><cites>FETCH-LOGICAL-c4224-8e3eae2b3666ddced0c344b4f7b7867f81ae7d7eef2333b84193db55575891803</cites><orcidid>0000-0003-3602-5405 ; 0000-0002-2716-3163 ; 0000-0003-0750-3818 ; 0000-0003-0201-3799</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fbjd.19694$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fbjd.19694$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,780,784,885,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33237568$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://amu.hal.science/hal-03156673$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Oei, W.</creatorcontrib><creatorcontrib>Fledderus, A.C.</creatorcontrib><creatorcontrib>Spuls, P.I</creatorcontrib><creatorcontrib>Eggen, C.A.M.</creatorcontrib><creatorcontrib>Kottner, J.</creatorcontrib><creatorcontrib>Horst, C.M.A.M.</creatorcontrib><creatorcontrib>Wolkerstorfer, A.</creatorcontrib><creatorcontrib>Kessel, M.S.</creatorcontrib><creatorcontrib>Krengel, S.</creatorcontrib><creatorcontrib>Etchevers, H.C.</creatorcontrib><creatorcontrib>Korfage, I.J.</creatorcontrib><creatorcontrib>Pasmans, S.G.M.</creatorcontrib><title>Development of an international core domain set for medium, large and giant congenital melanocytic naevi as a first step towards a core outcome set for clinical practice and research</title><title>British journal of dermatology (1951)</title><addtitle>Br J Dermatol</addtitle><description>Summary
Background
Medium, large and giant congenital melanocytic naevi (CMN) can impose a psychosocial burden on patients and families, and are associated with increased risk of developing melanoma or neurological symptoms. Lack of consensus on what outcomes to measure makes it difficult to advise patients and families about treatment and to set up best practice for CMN.
Objectives
Fostering consensus among patient representatives and professionals, we aim to develop a core outcome set, defined as the minimum set of outcomes to measure and report in care and all clinical trials of a specific health condition. We focused on the ‘what to measure’ aspect, the so‐called core domain set (CDS), following the COMET and CS‐COUSIN guidelines.
Methods
We conducted a systematic review to identify outcomes reported in the literature. Focus groups with patient representatives identified patient‐reported outcomes. All these outcomes were classified into domains. Through e‐Delphi surveys, 144 stakeholders from 27 countries iteratively rated the importance of domains and outcomes. An online consensus meeting attended by seven patient representatives and seven professionals finalized the CDS.
Results
We reached consensus on six domains, four of which were applied to both care and research: ‘quality of life’, ‘neoplasms’, ‘nervous system’ and ‘anatomy of skin’. ‘Adverse events’ was specific to care and ‘pathology’ to research.
Conclusions
We have developed a CDS for medium‐to‐giant CMN. Its application in reporting care and research of CMN will facilitate treatment comparisons. The next step will be to reach consensus on the specific outcomes for each of the domains and what instruments should be used to measure these domains and outcomes.
What is already known about this topic?
Medium, large and giant congenital melanocytic naevi (CMN) are associated with psychosocial burden for patients and their families because of their unusual appearance and increased risk of melanoma and/or neurocutaneous melanocytosis.
Outcome reporting of treatment options for CMN is heterogeneous. Current lack of consensus in outcome reporting hinders the development of evidence‐based treatment guidelines for CMN.
Development of a core outcome set (COS) may enhance standardized reporting.
What does this study add?
We focus on the core domain set, the ‘what to measure’, for the COS.
By following the guidelines of COMET and CS‐COUSIN, we reached consensus on six domains.
Four of the domains were applied to both care and research: ‘quality of life’, ‘neoplasms’, ‘nervous system’ and ‘anatomy of skin’. ‘Adverse events’ was specific to care and ‘pathology’ to research.
What are the clinical implications of this work?
Uptake of the core domain set in future clinical care of, and research about, medium‐to‐giant CMN should facilitate comparisons across different treatment choices for both patients and professionals.
Linked Comment: M.V. Heppt et al. Br J Dermatol 2021; 185:247–248.
Plain language summary available online</description><subject>Adverse events</subject><subject>Cancer</subject><subject>Clinical trials</subject><subject>Human health and pathology</subject><subject>Life Sciences</subject><subject>Melanoma</subject><subject>Nervous system</subject><subject>Patients</subject><subject>Quality of life</subject><issn>0007-0963</issn><issn>1365-2133</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp1kctu1DAUhiMEotPCghdAltiARFo7viRZ9gYFjcQG1pFjn0w9cuxgO1PNi_F8eJoyQkh4Y8n6zvdb5y-KNwSfk3wu-q0-J61o2bNiRajgZUUofV6sMMZ1iVtBT4rTGLcYE4o5flmcUFrRmotmVfy6gR1YP43gEvIDkg4ZlyA4mYx30iLlAyDtR2kcipDQ4AMaQZt5_IisDBvIIxptjMzzyrsNOJPy2AhWOq_2ySjkJOwMkhFJNJgQE4oJJpT8gwz68PgY4eek_AjHDGWNMyqbpiBVtiw5ASLIoO5fFS8GaSO8frrPih-fbr9f35Xrb5-_XF-uS8WqipUNUJBQ9VQIobUCjRVlrGdD3deNqIeGSKh1DTBUlNK-YaSluuec17xpSYPpWfFh8d5L203BjDLsOy9Nd3e57g5vmBIuRE13JLPvF3YK_ucMMXWjiQpsXgT4OXYVEwe_4E1G3_2Dbv2cd24zxQVhmLXVX-Eq-BgDDMcfENwdiu9y8d1j8Zl9-2Sc-1zPkfzTdAYuFuDBWNj_39Rdfb1ZlL8B9GO44w</recordid><startdate>202108</startdate><enddate>202108</enddate><creator>Oei, W.</creator><creator>Fledderus, A.C.</creator><creator>Spuls, P.I</creator><creator>Eggen, C.A.M.</creator><creator>Kottner, J.</creator><creator>Horst, C.M.A.M.</creator><creator>Wolkerstorfer, A.</creator><creator>Kessel, M.S.</creator><creator>Krengel, S.</creator><creator>Etchevers, H.C.</creator><creator>Korfage, I.J.</creator><creator>Pasmans, S.G.M.</creator><general>Oxford University Press</general><general>Wiley</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>1XC</scope><scope>VOOES</scope><orcidid>https://orcid.org/0000-0003-3602-5405</orcidid><orcidid>https://orcid.org/0000-0002-2716-3163</orcidid><orcidid>https://orcid.org/0000-0003-0750-3818</orcidid><orcidid>https://orcid.org/0000-0003-0201-3799</orcidid></search><sort><creationdate>202108</creationdate><title>Development of an international core domain set for medium, large and giant congenital melanocytic naevi as a first step towards a core outcome set for clinical practice and research</title><author>Oei, W. ; Fledderus, A.C. ; Spuls, P.I ; Eggen, C.A.M. ; Kottner, J. ; Horst, C.M.A.M. ; Wolkerstorfer, A. ; Kessel, M.S. ; Krengel, S. ; Etchevers, H.C. ; Korfage, I.J. ; Pasmans, S.G.M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4224-8e3eae2b3666ddced0c344b4f7b7867f81ae7d7eef2333b84193db55575891803</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adverse events</topic><topic>Cancer</topic><topic>Clinical trials</topic><topic>Human health and pathology</topic><topic>Life Sciences</topic><topic>Melanoma</topic><topic>Nervous system</topic><topic>Patients</topic><topic>Quality of life</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Oei, W.</creatorcontrib><creatorcontrib>Fledderus, A.C.</creatorcontrib><creatorcontrib>Spuls, P.I</creatorcontrib><creatorcontrib>Eggen, C.A.M.</creatorcontrib><creatorcontrib>Kottner, J.</creatorcontrib><creatorcontrib>Horst, C.M.A.M.</creatorcontrib><creatorcontrib>Wolkerstorfer, A.</creatorcontrib><creatorcontrib>Kessel, M.S.</creatorcontrib><creatorcontrib>Krengel, S.</creatorcontrib><creatorcontrib>Etchevers, H.C.</creatorcontrib><creatorcontrib>Korfage, I.J.</creatorcontrib><creatorcontrib>Pasmans, S.G.M.</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><jtitle>British journal of dermatology (1951)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Oei, W.</au><au>Fledderus, A.C.</au><au>Spuls, P.I</au><au>Eggen, C.A.M.</au><au>Kottner, J.</au><au>Horst, C.M.A.M.</au><au>Wolkerstorfer, A.</au><au>Kessel, M.S.</au><au>Krengel, S.</au><au>Etchevers, H.C.</au><au>Korfage, I.J.</au><au>Pasmans, S.G.M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Development of an international core domain set for medium, large and giant congenital melanocytic naevi as a first step towards a core outcome set for clinical practice and research</atitle><jtitle>British journal of dermatology (1951)</jtitle><addtitle>Br J Dermatol</addtitle><date>2021-08</date><risdate>2021</risdate><volume>185</volume><issue>2</issue><spage>371</spage><epage>379</epage><pages>371-379</pages><issn>0007-0963</issn><eissn>1365-2133</eissn><abstract>Summary
Background
Medium, large and giant congenital melanocytic naevi (CMN) can impose a psychosocial burden on patients and families, and are associated with increased risk of developing melanoma or neurological symptoms. Lack of consensus on what outcomes to measure makes it difficult to advise patients and families about treatment and to set up best practice for CMN.
Objectives
Fostering consensus among patient representatives and professionals, we aim to develop a core outcome set, defined as the minimum set of outcomes to measure and report in care and all clinical trials of a specific health condition. We focused on the ‘what to measure’ aspect, the so‐called core domain set (CDS), following the COMET and CS‐COUSIN guidelines.
Methods
We conducted a systematic review to identify outcomes reported in the literature. Focus groups with patient representatives identified patient‐reported outcomes. All these outcomes were classified into domains. Through e‐Delphi surveys, 144 stakeholders from 27 countries iteratively rated the importance of domains and outcomes. An online consensus meeting attended by seven patient representatives and seven professionals finalized the CDS.
Results
We reached consensus on six domains, four of which were applied to both care and research: ‘quality of life’, ‘neoplasms’, ‘nervous system’ and ‘anatomy of skin’. ‘Adverse events’ was specific to care and ‘pathology’ to research.
Conclusions
We have developed a CDS for medium‐to‐giant CMN. Its application in reporting care and research of CMN will facilitate treatment comparisons. The next step will be to reach consensus on the specific outcomes for each of the domains and what instruments should be used to measure these domains and outcomes.
What is already known about this topic?
Medium, large and giant congenital melanocytic naevi (CMN) are associated with psychosocial burden for patients and their families because of their unusual appearance and increased risk of melanoma and/or neurocutaneous melanocytosis.
Outcome reporting of treatment options for CMN is heterogeneous. Current lack of consensus in outcome reporting hinders the development of evidence‐based treatment guidelines for CMN.
Development of a core outcome set (COS) may enhance standardized reporting.
What does this study add?
We focus on the core domain set, the ‘what to measure’, for the COS.
By following the guidelines of COMET and CS‐COUSIN, we reached consensus on six domains.
Four of the domains were applied to both care and research: ‘quality of life’, ‘neoplasms’, ‘nervous system’ and ‘anatomy of skin’. ‘Adverse events’ was specific to care and ‘pathology’ to research.
What are the clinical implications of this work?
Uptake of the core domain set in future clinical care of, and research about, medium‐to‐giant CMN should facilitate comparisons across different treatment choices for both patients and professionals.
Linked Comment: M.V. Heppt et al. Br J Dermatol 2021; 185:247–248.
Plain language summary available online</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>33237568</pmid><doi>10.1111/bjd.19694</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0003-3602-5405</orcidid><orcidid>https://orcid.org/0000-0002-2716-3163</orcidid><orcidid>https://orcid.org/0000-0003-0750-3818</orcidid><orcidid>https://orcid.org/0000-0003-0201-3799</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | British journal of dermatology (1951), 2021-08, Vol.185 (2), p.371-379 |
| issn | 0007-0963 1365-2133 |
| language | eng |
| recordid | cdi_hal_primary_oai_HAL_hal_03156673v1 |
| source | Oxford University Press Journals All Titles (1996-Current); Wiley Online Library All Journals |
| subjects | Adverse events Cancer Clinical trials Human health and pathology Life Sciences Melanoma Nervous system Patients Quality of life |
| title | Development of an international core domain set for medium, large and giant congenital melanocytic naevi as a first step towards a core outcome set for clinical practice and research |
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