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Article ; Online: Association between dermatology follow-up and melanoma survival: A population-based cohort study.

Huang, Yuanshen / Fleming, Patrick / Fung, Kinwah / Chan, An-Wen

Journal of the American Academy of Dermatology

2024

Abstract: Background: Guidelines recommend that patients with melanoma undergo dermatologic examination at least annually. Adherence to follow-up and its impact on survival are unclear.: Objective: To determine the level of adherence to annual dermatologic ... ...

Abstract	Background: Guidelines recommend that patients with melanoma undergo dermatologic examination at least annually. Adherence to follow-up and its impact on survival are unclear. Objective: To determine the level of adherence to annual dermatologic follow-up in patients with primary cutaneous melanoma, identify predictors for better adherence, and evaluate whether adherence was associated with melanoma-related mortality. Methods: Retrospective inception cohort analysis of adults with primary invasive melanoma in Ontario, Canada from 2010 to 2013 with follow-up until December 31, 2018. Results: Adherence to dermatologic follow-up was variable with only 28.0% of patients seeing a dermatologist at least annually (median follow-up 5.0 years). Younger age, female sex, higher income, greater access to dermatology care, stage 2/3 melanoma, prior keratinocyte carcinoma, fewer comorbidities, and any outpatient visit in the 12 months prior to melanoma diagnosis were predictors for adherence. Greater adherence to annual dermatology visits was associated with reduced melanoma-specific mortality compared with lower levels of adherence (adjusted hazard ratio 0.64, 95% CI 0.52-0.78). Limitations: Observational study design and inability to identify skin examinations performed by non-dermatologists. Conclusion: Adherence to annual dermatology visits after melanoma diagnosis was low. Greater adherence may promote better patient survival but warrants confirmation in further research including randomized trials.
Language	English
Publishing date	2024-02-16
Publishing country	United States
Document type	Journal Article
ZDB-ID	603641-7
ISSN	1097-6787 ; 0190-9622
ISSN (online)	1097-6787
ISSN	0190-9622
DOI	10.1016/j.jaad.2024.02.015
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Article ; Online: The authors reply to: "Antihypertensives and skin cancer" and "Association between thiazide diuretics and skin cancer: still nebulous".

Drucker, Aaron M / Chan, An-Wen

CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne

2021 Volume 193, Issue 25, Page(s) E964

MeSH term(s)	Antihypertensive Agents/adverse effects ; Humans ; Hypertension/drug therapy ; Skin Neoplasms/drug therapy ; Sodium Chloride Symporter Inhibitors/adverse effects
Chemical Substances	Antihypertensive Agents ; Sodium Chloride Symporter Inhibitors
Language	English
Publishing date	2021-05-24
Publishing country	Canada
Document type	Letter ; Comment
ZDB-ID	215506-0
ISSN	1488-2329 ; 0008-4409 ; 0820-3946
ISSN (online)	1488-2329
ISSN	0008-4409 ; 0820-3946
DOI	10.1503/cmaj.79145
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Article ; Online: Top 10 research priorities for basal cell carcinoma: results of the Skin Investigation Network of Canada Priority Setting Initiative.

Shoimer, Ilya / Kleiner, Omer / Manion, Rachael / Dutz, Jan / Philip, Anie / Chan, An-Wen

The British journal of dermatology

2024 Volume 190, Issue 2, Page(s) 276–277

MeSH term(s)	Humans ; Canada ; Biomedical Research ; Carcinoma, Basal Cell ; Health Priorities
Language	English
Publishing date	2024-01-02
Publishing country	England
Document type	Journal Article
ZDB-ID	80076-4
ISSN	1365-2133 ; 0007-0963
ISSN (online)	1365-2133
ISSN	0007-0963
DOI	10.1093/bjd/ljad391
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Article ; Online: Repair of a Large Infraorbital Cheek Defect.

Mistry, Bhavik / Morand, Meggie / Liu, Michael / Chan, An-Wen

Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.

2023 Volume 50, Issue 5, Page(s) 477–479

MeSH term(s)	Humans ; Cheek/surgery ; Mohs Surgery ; Skin Neoplasms/surgery ; Skin Neoplasms/pathology ; Facial Neoplasms/surgery ; Carcinoma, Basal Cell/surgery ; Male ; Surgical Flaps ; Female ; Aged ; Plastic Surgery Procedures/methods
Language	English
Publishing date	2023-11-10
Publishing country	United States
Document type	Case Reports ; Journal Article
ZDB-ID	1227586-4
ISSN	1524-4725 ; 1076-0512
ISSN (online)	1524-4725
ISSN	1076-0512
DOI	10.1097/DSS.0000000000004021
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Article ; Online: Guidelines for reporting pediatric and child health clinical trial protocols and reports: study protocol for SPIRIT-Children and CONSORT-Children.

Baba, Ami / Smith, Maureen / Potter, Beth K / Chan, An-Wen / Moher, David / Offringa, Martin

Trials

2024 Volume 25, Issue 1, Page(s) 96

Abstract: Background: Despite the critical importance of clinical trials to provide evidence about the effects of intervention for children and youth, a paucity of published high-quality pediatric clinical trials persists. Sub-optimal reporting of key trial ... ...

Abstract	Background: Despite the critical importance of clinical trials to provide evidence about the effects of intervention for children and youth, a paucity of published high-quality pediatric clinical trials persists. Sub-optimal reporting of key trial elements necessary to critically appraise and synthesize findings is prevalent. To harmonize and provide guidance for reporting in pediatric controlled clinical trial protocols and reports, reporting guideline extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) guidelines specific to pediatrics are being developed: SPIRIT-Children (SPIRIT-C) and CONSORT-Children (CONSORT-C). Methods: The development of SPIRIT-C/CONSORT-C will be informed by the Enhancing the Quality and Transparency of Health Research Quality (EQUATOR) method for reporting guideline development in the following stages: (1) generation of a preliminary list of candidate items, informed by (a) items developed during initial development efforts and child relevant items from recent published SPIRIT and CONSORT extensions; (b) two systematic reviews and environmental scan of the literature; (c) workshops with young people; (2) an international Delphi study, where a wide range of panelists will vote on the inclusion or exclusion of candidate items on a nine-point Likert scale; (3) a consensus meeting to discuss items that have not reached consensus in the Delphi study and to "lock" the checklist items; (4) pilot testing of items and definitions to ensure that they are understandable, useful, and applicable; and (5) a final project meeting to discuss each item in the context of pilot test results. Key partners, including young people (ages 12-24 years) and family caregivers (e.g., parents) with lived experiences with pediatric clinical trials, and individuals with expertise and involvement in pediatric trials will be involved throughout the project. SPIRIT-C/CONSORT-C will be disseminated through publications, academic conferences, and endorsement by pediatric journals and relevant research networks and organizations. Discussion: SPIRIT/CONSORT-C may serve as resources to facilitate comprehensive reporting needed to understand pediatric clinical trial protocols and reports, which may improve transparency within pediatric clinical trials and reduce research waste. Trial registration: The development of these reporting guidelines is registered with the EQUATOR Network: SPIRIT-Children ( https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials-protocols/#35 ) and CONSORT-Children ( https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#CHILD ).
MeSH term(s)	Humans ; Child ; Adolescent ; Child Health ; Checklist ; Consensus ; Research Design ; Reference Standards
Language	English
Publishing date	2024-01-30
Publishing country	England
Document type	Journal Article
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1745-6215
ISSN (online)	1745-6215
ISSN	1468-6694 ; 1745-6215
DOI	10.1186/s13063-024-07948-7
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Article ; Online: Blindsided: challenging the dogma of masking in clinical trials.

Drucker, Aaron M / Chan, An-Wen

BMJ (Clinical research ed.)

2020 Volume 368, Page(s) m229

MeSH term(s)	Clinical Trials as Topic ; Epidemiologic Studies ; Research Design
Language	English
Publishing date	2020-01-21
Publishing country	England
Document type	Editorial ; Comment
ZDB-ID	1362901-3
ISSN	1756-1833 ; 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
ISSN (online)	1756-1833
ISSN	0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
DOI	10.1136/bmj.m229
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Article ; Online: Characterization of discontinuation and nonpublication of phase III randomized clinical trials of psoriasis.

Lam, Megan / Monaghan, Caitlin / Chan, An-Wen / Drucker, Aaron M

The British journal of dermatology

2022 Volume 187, Issue 1, Page(s) 127–129

MeSH term(s)	Clinical Trials, Phase III as Topic ; Humans ; Psoriasis/drug therapy ; Publishing ; Randomized Controlled Trials as Topic ; Severity of Illness Index
Language	English
Publishing date	2022-04-19
Publishing country	England
Document type	Letter
ZDB-ID	80076-4
ISSN	1365-2133 ; 0007-0963
ISSN (online)	1365-2133
ISSN	0007-0963
DOI	10.1111/bjd.21025
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Article ; Online: Surrogate endpoints in trials: a call for better reporting.

Ciani, Oriana / Manyara, Anthony M / Chan, An-Wen / Taylor, Rod S

Trials

2022 Volume 23, Issue 1, Page(s) 991

Abstract: Using a surrogate endpoint as a substitute for a patient-relevant final outcome enables randomised controlled trials (RCTs) to be conducted more efficiently. However, the use of surrogates remains controversial and there is currently no guideline for the ...

Abstract	Using a surrogate endpoint as a substitute for a patient-relevant final outcome enables randomised controlled trials (RCTs) to be conducted more efficiently. However, the use of surrogates remains controversial and there is currently no guideline for the reporting of RCTs using surrogate endpoints; therefore, we seek to develop SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) extensions to improve the reporting of these trials. We would like to invite interested individuals (trial methodologists, journal editors, healthcare industry, regulators and payers, and patient/public representative groups), particularly those with experience in the use of surrogate endpoints in trials.
Language	English
Publishing date	2022-12-12
Publishing country	England
Document type	Letter
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1745-6215
ISSN (online)	1745-6215
ISSN	1468-6694 ; 1745-6215
DOI	10.1186/s13063-022-06904-7
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Article ; Online: Directrices para los protocolos de ensayos clínicos de intervenciones con inteligencia artificial: la extensión SPIRIT-AI

Cruz Rivera, Samantha / Liu, Xiaoxuan / Chan, An-Wen / Denniston, Alastair K / Calvert, Melanie J

Revista panamericana de salud publica = Pan American journal of public health

2023 Volume 48, Page(s) e12

Abstract: The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent ... ...

Title translation	Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extensionDiretrizes para protocolos de ensaios clínicos com intervenções que utilizam inteligência artificial: a extensão SPIRIT-AI.
Abstract	The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 26 candidate items, which were consulted upon by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items that were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations for the handling of input and output data, the human-AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial.
Language	Spanish
Publishing date	2023-02-01
Publishing country	United States
Document type	Case Reports ; English Abstract
ZDB-ID	1376934-0
ISSN	1680-5348 ; 1020-4989
ISSN (online)	1680-5348
ISSN	1020-4989
DOI	10.26633/RPSP.2024.12
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Article ; Online: Directrices para los protocolos de ensayos clínicos de intervenciones con inteligencia artificial: la extensión SPIRIT-AI

Cruz Rivera, Samantha / Liu, Xiaoxuan / Chan, An-Wen / Denniston, Alastair K / Calvert, Melanie J

Revista panamericana de salud publica = Pan American journal of public health

2023 Volume 47, Page(s) e149

Title translation	Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extensionDiretrizes para protocolos de ensaios clínicos com intervenções que utilizam inteligência artificial: a extensão SPIRIT-AI.
Abstract	The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 26 candidate items, which were consulted upon by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items that were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations for the handling of input and output data, the human-AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial.
Language	Spanish
Publishing date	2023-12-08
Publishing country	United States
Document type	Case Reports ; English Abstract
ZDB-ID	1376934-0
ISSN	1680-5348 ; 1020-4989
ISSN (online)	1680-5348
ISSN	1020-4989
DOI	10.26633/RPSP.2023.149
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