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Background and Objective: Breast cancer (BC) is the most prevalent cancer among women worldwide. With a growing number of BC survivors (BCSs), the number of survivors who require highquality survivorship care is increasing. Various recommendations have been proposed for survivorship care plans (SCPs). However, globally, limited progress has been made to implement these recommendations consistently in cancer care centers. This review explores the gaps and challenges that exist in BC survivorship care (BCSC) and proposes future directions for improving survivorship care for patients and the healthcare system., Methods: Current literature on BCSC was searched using PubMed and Google Scholar. The search strategy utilized a combination of keywords related to BCSC, gaps in survivorship care, and health promotion. Retrievable and English articles from January 2000 to March 2024 were included in the review., Key Content and Findings: Despite the large number of guidelines and recommendations on best BCSC practices, only a small number of these have been translated into clinical practices that help streamline patient care. There are many gaps to the provision of high-quality survivorship care, all of which negatively affect patient outcomes. Some of these gaps include but are not limited to: the limited role of primary care providers (PCPs), lack of coordination of care, lack of evidence-based research, insufficient data on health promotion, and challenges implementing comprehensive care., Conclusions: These findings indicate the need for a holistic and personalized approach to BCSC. The importance of implementing a multi-disciplinary and coordinated approach to survivorship care has been emphasized. This includes further involvement of PCPs, through increased training for PCPs in survivorship care. Despite available models of survivorship care, further research is needed to determine optimal BCSC that improves patient outcomes while decreasing the strain on the healthcare system. Additionally, technology can play a beneficial role in survivorship care, especially through telehealth and artificial intelligence (AI). Nonetheless, further research is needed on BCSC.

Background/Objectives: Uveal melanoma is the most common primary intraocular malignancy in adults. Treatment options for localized, early-stage disease include enucleation, brachytherapy, and proton beam therapy. This review aims to evaluate the role of proton therapy in the definitive management of uveal melanoma, focusing on its physics, radiobiology, treatment techniques, and associated outcomes. Methods: This narrative review synthesizes current literature on proton therapy for uveal melanoma, emphasizing case selection, treatment efficacy, and side effects. Results: Proton therapy offers significant advantages for thicker uveal melanomas (over 8 mm) due to its unique physical properties, including a rapid dose fall-off that protects critical structures like the retina and optic nerve. Proton therapy may have benefits in tumor control for ocular melanomas given its increased relative biological effectiveness relative to photon therapy for these typically more radioresistant melanomas. Proton therapy may also hold special value for uveal melanomas in close proximity to the optic nerve, as patients are at high risk of visual toxicities with brachytherapy. The review discusses the efficacy of proton therapy across small, medium, and large tumors, along with strategies for improving patient survival through combined systemic therapy. Additionally, the potential of ocular reirradiation with proton therapy is addressed. Conclusions: Proton therapy is an effective treatment for uveal melanoma. It offers advantages over brachytherapy for large tumors, tumors that are close to the optic nerve or insertion of extra-ocular muscles.

Purpose: Ductal carcinoma in situ (DCIS) of the breast is one of the most common pre-invasive cancers diagnosed in women. Quality of life (QoL) is extremely important to assess in studies including these patients due to the favorable prognosis of the disease. The primary objective of this systematic review was to compile a comprehensive list of QoL issues, all existing QoL assessment tools, and patient-reported outcome measures used to assess DCIS., Methods: A search was conducted on Ovid MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases from inception to August 2023, using keywords such as "ductal carcinoma in-situ", "quality of life", and "patient-reported outcomes." QoL issues and QoL tools in primary research studies were extracted., Results: A total of 67 articles identified issues pertaining to patients with DCIS spanning physical, functional, and psychosocial QoL domains. Physical and functional issues observed in patients included pain, fatigue, and impaired sexual functioning. Psychosocial issues such as anxiety, depression, and confusion about one's disease were also common. QoL tools included those that assessed general QoL, breast cancer-specific tools, and issue-specific questionnaires., Conclusion: The current instruments available to assess QoL in patients with DCIS do not comprehensively capture the issues that are pertinent to patients. Thus, the modification of existing tools or the creation of a DCIS-specific QoL tool is recommended to ensure that future research will be sensitive towards challenges faced by patients with DCIS., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Barrier films or dressings were reported to be effective in preventing radiation dermatitis (RD) in breast cancer patients, but their comparative efficacy is unknown., Methods: A systematic literature search was performed on Embase, MEDLINE and Cochrane CENTRAL Registry of Clinical Trials from inception to October 20, 2023. Randomised controlled trials (RCTs) comparing barrier films or dressings to the standard of care (SOC) or other interventions were included. We estimated summary odds ratios and mean differences using network meta-analysis with random effects. This study was registered with PROSPERO (ID: CRD42023475021)., Results: Fourteen RCTs met inclusion criteria. Six interventions were analysed: 3M™ Moisturizing Double Barrier Cream (MDBC), 3M™ No Sting Barrier Film (BF), Hydrofilm® (HF), Mepitel® Film (MF), Silver Leaf Nylon Dressing and StrataXRT®. HF, MF and StrataXRT® reduced the incidence of moist desquamation compared to SOC (HF: OR = 0.08; p = 0.02; MF: OR = 0.31 p < 0.01; StrataXRT®: OR = 0.22, p = 0.04). The ranking of agents from most to least effective in preventing moist desquamation according to P-scores was HF (92.5%), MF (78.5%), StrataXRT® (70.1%), BF (46.4%), Silver Leaf Nylon Dressing (24.9%), MDBC (22.9%) and SOC (14.7%). Only four RCTs on HF and MF included patient-reported outcome (PRO) assessments that allowed pooling for analysis. HF and MF were more effective in reducing pain, itchiness and burning sensation compared to SOC (p < 0.01 for all symptoms)., Conclusion: HF and MF were effective in preventing RD in breast cancer. Future RCTs should compare these interventions to effective cream preparations, such as topical corticosteroids., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: To provide a comprehensive assessment of various fractionation schemes in radiation therapy for breast cancer, with a focus on side effects, cosmesis, quality of life, risks of recurrence, and survival outcomes., Design: Systematic review and meta-analysis., Data Sources: Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (from inception to 23 October 2023)., Study Selection: Included studies were randomised controlled trials focusing on conventional fractionation (CF; daily fractions of 1.8-2 Gy, reaching a total dose of 50-50.4 Gy over 5-6 weeks), moderate hypofractionation (MHF; fraction sizes of 2.65-3.3 Gy for 13-16 fractions over 3-5 weeks), and/or ultra-hypofractionation (UHF; schedule of only 5 fractions)., Data Extraction: Two independent investigators screened studies and extracted data. Risk of bias and quality of evidence were assessed using the Cochrane Collaboration's tool and the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) approach, respectively., Data Synthesis: Pooled risk ratios (RRs) and hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated using a random effects model. Heterogeneity was analysed using Cochran's Q test and I 2 statistic. Network meta-analysis was used to integrate all available evidence., Main Outcome Measures: The pre-specified primary outcome was grade ≥2 acute radiation dermatitis and late radiation therapy related side effects; secondary outcomes included cosmesis, quality of life, recurrence, and survival metrics., Results: From 1754 studies, 59 articles representing 35 trials (20 237 patients) were assessed; 21.6% of outcomes showed low risk of bias, whereas 78.4% had some concerns or high risk, particularly in outcome measurement (47.4%). The RR for grade ≥2 acute radiation dermatitis for MHF compared with CF was 0.54 (95% CI 0.49 to 0.61; P<0.001) and 0.68 (0.49 to 0.93; P=0.02) following breast conserving therapy and mastectomy, respectively. Hyperpigmentation and grade ≥2 breast shrinkage were less frequent after MHF than after CF, with RRs of 0.77 (0.62 to 0.95; P=0.02) and 0.92 (0.85 to 0.99; P=0.03), respectively, in the combined breast conserving therapy and mastectomy population. However, in the breast conserving therapy only trials, these differences in hyperpigmentation (RR 0.79, 0.60 to 1.03; P=0.08) and breast shrinkage (0.94, 0.83 to 1.07; P=0.35) were not statistically significant. The RR for grade ≥2 acute radiation dermatitis for UHF compared with MHF was 0.85 (0.47 to 1.55; P=0.60) for breast conserving therapy and mastectomy patients combined. MHF was associated with improved cosmesis and quality of life compared with CF, whereas data on UHF were less conclusive. Survival and recurrence outcomes were similar between UHF, MHF, and CF., Conclusions: MHF shows improved safety profile, cosmesis, and quality of life compared with CF while maintaining equivalent oncological outcomes. Fewer randomised controlled trials have compared UHF with other fractionation schedules, but its safety and oncological effectiveness seem to be similar with short term follow-up. Given the advantages of reduced treatment time, enhanced convenience for patients, and potential cost effectiveness, MHF and UHF should be considered as preferred options over CF in appropriate clinical settings, with further research needed to solidify these findings., Systematic Review Registration: PROSPERO CRD42023460249., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at https://www.icmje.org/disclosure-of-interest/ and declare: no support from any organisation for the submitted work; IC has received consulting fees from Pfizer, Novartis, Eli Lilly, Seagen, Gilead, Astra Zeneca, Daiichi Sankyo, and Menarini StemLine and is a clinical board member of the European Society for Radiotherapy and Oncology (unpaid); JQC has received funding from the Canadian Institutes of Health Research and honorariums from Roche, Pfizer, Novartis, AstraZeneca, Well Doc Alberta, Merck, La Roche-Posay, Knight, Seagen, Oncology Education, and Gilead; no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Breast cancer (BC) diagnoses not only present physical challenges but profoundly affect survivors' psychosocial well-being leading to sexual health challenges. This clinical practice review aimed to discuss the current literature and outline the knowledge gaps related to care for sexual health after BC, including survivors' sexual health concerns, as well as available prospective surveillance programs. Current literature on the sexual health challenges of BC survivors was identified and sorted into contributing factors, treatments and interventions, and practice recommendations. This evidence was then used to identify gaps in the literature and make recommendations for future research. BC survivors experience a variety of physical symptoms, such as pain during sex or dyspareunia, which impair sexual well-being. Additionally, dissatisfaction with sexual function may arise due to psychosocial stressors (e.g., depression or body image concerns) and the inverse may worsen psychological well-being. Treatments can have lasting effects that may impact sexual function, often reciprocally related to physical and psychosocial factors. Current treatments for sexual dysfunction involve topical products for vaginal symptoms (e.g., creams, pH-balanced gels, hyaluronic acid or vitamin E suppositories, natural oils, topical estrogen, or lubricants) and various counseling and educational interventions (e.g., mental health counseling, sex therapy, or couples-based psychotherapy). There is a general lack of research considering the ways in which intersectional concerns can impact sexual health experiences after BC. Existing studies do not often consider potential differences in needs that may arise due to ethnicity, age, or socioeconomic background. To address these limitations a significant paradigm shift in survivorship care. This requires moving beyond disease management towards a more holistic, comprehensive, patient-centered approach prioritizing comfort and sexual well-being.

Objective: This umbrella review synthesises evidence on the methods used to recruit and retain ethnically diverse participants and report and analyse variables related to ethnic diversity in randomised controlled trials., Design: Umbrella review., Data Sources: Ovid MEDLINE, Ovid Embase, CINAHL, PsycINFO and Cochrane and Campbell Libraries for review papers published between 1 January 2010 and 13 May 2024., Eligibility Criteria: English language systematic reviews focusing on inclusion and reporting of ethnicity variables. Methodological quality was assessed using the AMSTAR 2 tool., Results: Sixty-two systematic reviews were included. Findings point to limited representation and reporting of ethnic diversity in trials. Recruitment strategies commonly reported by the reviews were community engagement, advertisement, face-to-face recruitment, cultural targeting, clinical referral, community presentation, use of technology, incentives and research partnership with communities. Retention strategies highlighted by the reviews included frequent follow-ups on participants to check how they are doing in the study, provision of incentives, use of tailored approaches and culturally appropriate interventions. The findings point to a limited focus on the analysis of variables relevant to ethnic diversity in trials even when they are reported in trials., Conclusion: Significant improvements are required in enhancing the recruitment and retention of ethnically diverse participants in trials as well as analysis and reporting of variables relating to diversity in clinical trials., Prospero Registration Number: CRD42022325241., Competing Interests: Competing interests: BB has received funds from the Australian National Health and Medical Research Council for projects related to dementia, ethnicity and ageing. HG works for COUCH Health, which undertakes research commissioned by the pharmaceutical, academic and charity sectors. No COUCH Health clients participated in the collection, analysis or interpretation of the data for the RECONSIDER Project. None of the other authors have any conflicts of interest to declare., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Objectives: This consensus was developed by the Asian EUS Group (AEG), who aimed to formulate a set of practice guidelines addressing various aspects of endoscopic ultrasound-guided tissue acquisition (EUS-TA)., Methods: The AEG initiated the development of consensus statements and formed an expert panel comprising surgeons, gastroenterologists, and pathologists. Three online consensus meetings were conducted to consolidate the statements and votes. The statements were presented and discussed in the first two consensus meetings and revised according to comments. Final voting was conducted at a third consensus meeting. The Grading of Recommendations, Assessment, Development, and Evaluation system was adopted to define the strength of the recommendations and quality of evidence., Results: A total of 20 clinical questions and statements regarding EUS-TA were formulated. The committee recommended that fine-needle biopsy (FNB) needles be preferred over conventional fine-needle aspiration (FNA) needles for EUS-TA of subepithelial lesions. For solid pancreatic masses, rapid on-site evaluation is not routinely recommended when FNB needles are used. For dedicated FNB needles, fork-tip and Franseen-tip needles have essentially equivalent performance., Conclusion: This consensus provides guidance for EUS-TA, thereby enhancing the quality of EUS-TA., (© 2024 The Authors. Digestive Endoscopy published by John Wiley & Sons Australia, Ltd on behalf of Japan Gastroenterological Endoscopy Society.)

Competing Interests: The authors declare no conflicts of interest.

Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the UK Medical Research Council for the submitted work. SB is a member of the NICE Decision Support Unit and NICE Guidelines Technical Support Unit; has served as a paid consultant, providing methodological advice, to NICE, Roche, IQVIA, and RTI Health Solutions; received payments for educational events from Roche; and has received research funding from European Federation of Pharmaceutical Industries and Associations and Johnson & Johnson. MOu works for and has shares in AstraZeneca. JSR is a deputy editor at JAMA, was formerly an associate editor at The BMJ, and is co-founder (unpaid) of medRxiv; has received research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology, from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation programme (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (R01HS025164, R01HL144644), and from Arnold Ventures; was an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in September 2022. NJB has received consulting fees from Nobias Therapeutics. AA and YR are associate editors at BMC Trials. OC is an associate editor for Value in Health and has received consulting fees from MSD and Janssen. RC is a founding member of the OMERACT Technical Advisory Group, which might be perceived as a possible conflict of interest. RH has shares in Johnson & Johnson. JHP has been a consultant for AdaptivePhage, Arrevus, Atheln, BavariaNordic, Cellularity, Eicos, Evofem, Eyecheck, Gilead, GSK, Mustang, OPKO, Otsuka, Resolve, Romark, SpineBioPPharma, and UTIlity,Vir. GSC is a statistics editor for The BMJ, and director of the UK EQUATOR Centre. CJW has undertaken consultancy for AB Science, for which his institution has received a fee. DD is an associate editor of Value in Health.

Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the UK Medical Research Council for the submitted work. SB is a member of the NICE Decision Support Unit and NICE Guidelines Technical Support Unit; has served as a paid consultant, providing methodological advice, to NICE, Roche, IQVIA, and RTI Health Solutions; received payments for educational events from Roche; and has received research funding from European Federation of Pharmaceutical Industries and Associations and Johnson & Johnson. MOu works for and has shares in AstraZeneca. JSR is a deputy editor at JAMA, was formerly an associate editor at The BMJ, and is co-founder (unpaid) of medRxiv; has received research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology, from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation programme (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (R01HS025164, R01HL144644), and from Arnold Ventures; was an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in September 2022. NJB has received consulting fees from Nobias Therapeutics. AA and YR are associate editors at BMC Trials. OC is an associate editor for Value in Health and has received consulting fees from MSD and Janssen. RC is a founding member of the OMERACT Technical Advisory Group, which might be perceived as a possible conflict of interest. RH has shares in Johnson & Johnson. JHP has been a consultant for AdaptivePhage, Arrevus, Atheln, BavariaNordic, Cellularity, Eicos, Evofem, Eyecheck, Gilead, GSK, Mustang, OPKO, Otsuka, Resolve, Romark, SpineBioPPharma, and UTIlity,Vir. GSC is a statistics editor for The BMJ, and director of the UK EQUATOR Centre. CJW has undertaken consultancy for AB Science, for which his institution has received a fee. DD is an associate editor of Value in Health.

Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: EYL has received speaker honorarium from Sanofi and AstraZeneca. IT: none. AWC: none. JB: none. RB is an advisory board member, consultant, speaker, and/or investigator for and receives honoraria and/or grant from AbbVie, Amgen, Arcutis, Asana BioSciences, Bellus Health, BioMimetix, Bluefin Biomedicine, Boehringer-Ingelheim, Boston, CARA Therapeutic, Clexio, Dermavant, Eli Lilly, Escient, Evidera, Fresh Tracks (Brickell), Galderma, GlaxoSmithKline, Incyte, Inmagene Bio, Janssen, LEO Pharma, Novartis, Opsidio, Pfizer, RAPT Therapeutic, Regeneron, Sanofi, Target RWE and Vyne Therapeutics. RB is also an employee and shareholder of Innovaderm Research. HC: none. ACM: none. MG has been an investigator, speaker, and/or advisor for: AbbVie, Amgen, Akros, Arcutis, Aristea, AnaptysBio, Apogee, Bausch Health, BMS, Boehringer Ingelheim, Celgene, Dermira, Dermavant, Eli Lilly, Galderma, GSK, Incyte, Janssen, Kyowa Kirin, LEO Pharma, MedImmune, Meiji, Merck, Moonlake, Nimbus, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, Tarsus, Takeda, UCB, Union and Ventyx. NH was on the advisory board/ round table honoraria for L’Oreal, Abbvie, Leo, Sun, Eucerin, Lilly, J&J, Arcutis, Sanofi, and Regeneron. HCHH has been an investigator for and/or speaker for and/or received honoraria from the following companies: Abbvie, Amgen, Arcutis, Bausch Health, Boehringer-Ingelheim, Bristol Meyers Squibb, Celgene, Cutanea, Dermira, Dermavant, DS Biopharma, Eli Lilly, Galderma, GSK, Incyte, Janssen, Leo Pharma, Medimmune, Merck, Mirimar, Novartis, Pfizer, Regeneron, Sanofi-Genzyme, Roche, and UCB. NJL: none. JALM: none. RM: none. KP received honoraria from AbbVie, Acelyrin, Akros, Amgen, Aralez Pharmaceuticals, Bausch Health/Valeant, Boehringer Ingelheim Celgene, Celltrion, Coherus, Dermavant, Dice Pharmaceuticals, Eli Lilly, Forbion, Galderma, Janssen, Kyowa Hakko Kirin, Leo, Meiji Seika Pharma, Merck (MSD), Mitsubishi Pharma, Novartis, Pfizer, Reistone, Sanofi-Aventis/Genzyme, Sandoz, Sun Pharma, Takeda, UCB, and vTv Therapeutics. KP received clinical research grants from AbbVie, Akros, Amgen, Anacor, Arcutis, Avillion, Bausch Health/Valeant, Boehringer Ingelheim, Bristol-Myers Squibb, Can-Fite Biopharma, Celgene, Coherus, CorEvitas, Dermavant, Dermira, Dow Pharma, Eli Lilly, Evelo, Galderma, Gilead, GSK, Incyte, Janssen, Kyowa Hakko Kirin, Leo, Merek (MSD), Novartis, Pfizer, Regeneron, Roche, Sanofi-Aventis/Genzyme, Sun Pharma, Takeda, and UCB. AMD has received compensation from the British Journal of Dermatology (reviewer and Section Editor), American Academy of Dermatology (guidelines writer), National Eczema Association (grant reviewer), Canadian Dermatology Today (manuscript writer), and Canadian Agency for Drugs and Technologies in Health (consultant). Dr Drucker has received research grants to his institution from the National Eczema Association, Eczema Society of Canada, Canadian Dermatology Foundation, Canadian Institutes for Health Research, US National Institutes of Health, and Physicians Services Incorporated Foundation.

Psychosis, defined as a set of symptoms that results in a distorted sense of reality, is observed in several psychiatric disorders in addition to schizophrenia. This paper reviews the literature relevant to the underlying neurobiology of psychosis. The dopamine hypothesis has been a major influence in the study of the neurochemistry of psychosis and in development of antipsychotic drugs. However, it became clear early on that other factors must be involved in the dysfunction involved in psychosis. In the current review, it is reported how several of these factors, namely dysregulation of neurotransmitters [dopamine, serotonin, glutamate, and γ-aminobutyric acid (GABA)], neuroinflammation, glia (microglia, astrocytes, and oligodendrocytes), the hypothalamic-pituitary-adrenal axis, the gut microbiome, oxidative stress, and mitochondrial dysfunction contribute to psychosis and interact with one another. Research on psychosis has increased knowledge of the complexity of psychotic disorders. Potential new pharmacotherapies, including combinations of drugs (with pre- and probiotics in some cases) affecting several of the factors mentioned above, have been suggested. Similarly, several putative biomarkers, particularly those related to the immune system, have been proposed. Future research on both pharmacotherapy and biomarkers will require better-designed studies conducted on an all stages of psychotic disorders and must consider confounders such as sex differences and comorbidity.

Objectives: Lack of ethnic diversity in trials may contribute to health disparities and to inequity in health outcomes. The primary objective was to investigate the experiences and perspectives of ethnically diverse populations about how to improve ethnic diversity in trials., Study Design and Setting: Qualitative data were collected via 16 focus groups with participants from 21 ethnically diverse communities in Australia. Data collection took place between August and September 2022 in community-based settings in six capital cities: Sydney, Melbourne, Perth, Adelaide, Brisbane, and Darwin, and one rural town: Bordertown (South Australia)., Results: One hundred and fifty-eight purposively sampled adults (aged 18-85, 49% women) participated in groups speaking Tamil, Greek, Punjabi, Italian, Mandarin, Cantonese, Karin, Vietnamese, Nepalese, and Arabic; or English-language groups (comprising Fijian, Filipino, African, and two multicultural groups). Only 10 participants had previously taken part in medical research including three in trials. There was support for medical research, including trials; however, most participants had never been invited to participate. To increase ethnic diversity in trial populations, participants recommended recruitment via partnering with communities, translating trial materials and making them culturally accessible using audiovisual ways, promoting retention by minimizing participant burden, establishing trust and rapport between participants and researchers, and sharing individual results. Participants were reluctant to join studies on taboo topics in their communities (eg, sexual health) or in which physical specimens (eg, blood) were needed. Participants said these barriers could be mitigated by communicating about the topic in more culturally cognizant and safe ways, explaining how data would be securely stored, and reinforcing the benefit of medical research to humanity., Conclusion: Participants recognized the principal benefits of trials and other medical research, were prepared to take part, and offered suggestions on recruitment, consent, data collection mechanisms, and retention to enable this to occur. Researchers should consider these community insights when designing and conducting trials; and government, regulators, funders, and publishers should allow for greater innovation and flexibility in their processes to enable ethnic diversity in trials to improve., Competing Interests: Declaration of competing interest B.B. has received funds from the Australian National Health and Medical Research Council for projects related to dementia, ethnicity, and aging. H.G. works for COUCH Health, which undertakes research commissioned by the pharmaceutical, academic, and charity sectors. No COUCH Health clients participated in the collection, analysis, or interpretation of the data for the RECONSIDER Project. There are no competing interests for any other author., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

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., Competing Interests: Conflicts of interest Dr Fleming has received honorarium and/or consulting and/or advisory boards and/or speaking fees and/or been an investigator for AbbVie, Altius, Amgen, Aralez, Bausch Health, Cipher, Galderma, Eli Lilly, L'Oreal, UCB, Janssen, Medexus Pharmaceuticals, Novartis, Pfizer and Sanofi-Genzyme, and Sun Pharma for work unrelated to this manuscript; Dr Huang has received honorarium or advisory board consulting fees for AbbVie, Novartis, UCB, CeraVe, Galderma, and Sanofi for work unrelated to this manuscript. Author Fung and Dr Chan have no conflicts of interest to declare., (Copyright © 2024 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Merkel cell carcinoma (MCC) is a rare, aggressive skin cancer that most commonly occurs in ultraviolet-exposed body sites. The epidemiology of MCC in different geographies and populations is not well characterized., Objectives: The objective of this systematic review is to summarize evidence on the incidence, mortality and survival rates of MCC from population-based studies., Methods: We searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials from database inception to 6 June 2023. No geographic, age or date exclusions were applied. We included population-based studies of MCC that reported the incidence, survival or mortality rate, and also considered systematic reviews. A data-charting form was created and validated to identify variables to extract. Two reviewers then independently charted the data for each included study with patient characteristics, and estimates of incidence rate, mortality rate, and survival rate and assessed the quality of included studies using the Joanna Briggs Institute Checklist for Prevalence studies, Newcastle-Ottawa Scale and Assessment of Multiple Systematic Reviews. We abstracted age-, sex-, stage- and race-stratified outcomes, and synthesized comparisons between strata narratively and using vote counting. We assessed the certainty of evidence for those comparisons using the Grading of Recommendations, Assessments, Developments and Evaluations framework., Results: We identified 11 472 citations, of which 52 studies from 24 countries met our inclusion criteria. Stage I and the head and neck were the most frequently reported stage and location at diagnosis. The incidence of MCC is increasing over time (high certainty), with the highest reported incidences reported in southern hemisphere countries [Australia (2.5 per 100 000); New Zealand (0.96 per 100 000) (high certainty)]. Male patients generally had higher incidence rates compared with female patients (high certainty), although there were some variations over time periods. Survival rates varied, with lower survival and/or higher mortality associated with male sex (moderate certainty), higher stage at diagnosis (moderate-to-high certainty), older age (moderate certainty), and immunosuppression (low-to-moderate certainty)., Conclusions: MCC is increasing in incidence and may increase further given the ageing population of many countries. The prognosis of MCC is poor, particularly for male patients, those who are immunosuppressed, and patients diagnosed at higher stages or at an older age., Competing Interests: Conflicts of interest A.M.D. has received compensation from the British Journal of Dermatology (Section Editor), American Academy of Dermatology (guidelines writer), National Eczema Association (grant reviewer) and Canadian Agency for Drugs and Technologies in Health (consultant). A.M.D. has received research grants to his institution from the National Eczema Association, Eczema Society of Canada, Canadian Dermatology Foundation, Canadian Institutes for Health Research, National Institutes of Health and Physicians Services Incorporated Foundation. J.J.L. is a consultant for Feldan Bio, Inc., (© The Author(s) 2023. Published by Oxford University Press on behalf of British Association of Dermatologists.)

Intense interest surrounds current research on psychedelics, particularly regarding their potential in treating mental health disorders. Various studies suggest a link between the subjective effects produced by psychedelics and their therapeutic efficacy. Neuroimaging evidence indicates an association of changes in brain functional connectivity with the subjective effects of psychedelics. We conducted a review focusing on psychedelics and brain functional connectivity. The review focused on four psychedelic drugs: ayahuasca, psilocybin and LSD, and the entactogen MDMA. We conducted searches in databases of MEDLINE, Embase, APA PsycInfo and Scopus from inception to Jun 2023 by keywords related to functional connectivity and psychedelics. Using the PRISMA framework, we selected 24 articles from an initial pool of 492 for analysis. This scoping review and analysis investigated the effects of psychedelics on subjective experiences and brain functional connectivity in healthy individuals. The studies quantified subjective effects through psychometric scales, revealing significant experiences of altered consciousness, mood elevation, and mystical experiences induced by psychedelics. Neuroimaging results indicated alterations in the functional connectivity of psychedelics, with consistent findings across substances of decreased connectivity within the default mode network and increased sensory and thalamocortical connectivity. Correlations between these neurophysiological changes and subjective experiences were noted, suggesting a brain network basis of the psychedelics' neuropsychological impact. While the result of the review provides a potential neural mechanism of the subjective effects of psychedelics, direct clinical evidence is needed to advance their clinical outcomes. Our research serves as a foundation for further exploration of the therapeutic potential of psychedelics., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (Copyright © 2024 Yu, Burback, Winkler, Xu, Dennett, Vermetten, Greenshaw, Li, Milne, Wang, Cao, Winship, Zhang and Chan.)

Background: It has not been clearly established if skin cancer or melanoma are manifestations of BRCA1 or BRCA2 mutation carrier status. Estimating the risk of skin cancer is an important step towards developing screening recommendations., Methods: We report the findings of a prospective cohort study of 6,207 women from North America who carry BRCA1 or BRCA2 mutations. Women were followed from the date of baseline questionnaire to the diagnosis of skin cancer, to age 80 years, death from any cause, or the date of last follow-up., Results: During the mean follow-up period of eight years, 3.7% of women with a BRCA1 mutation (133 of 3,623) and 3.8% of women with a BRCA2 mutation (99 of 2,584) reported a diagnosis of skin cancer (including both keratinocyte carcinomas and melanoma). The cumulative risk of all types of skin cancer from age 20 to 80 years was 14.1% for BRCA1 carriers and 10.7% for BRCA2 carriers. The cumulative risk of melanoma was 2.5% for BRCA1 carriers and 2.3% for BRCA2 carriers, compared to 1.5% for women in the general population in the United States. The strongest risk factor for skin cancer was a prior diagnosis of skin cancer., Conclusion: The risk of non-melanoma skin cancer in women who carry a mutation in BRCA1 or BRCA2 is similar to that of non-carrier women. The risk of melanoma appears to be slightly elevated. We suggest that a referral to a dermatologist or primary care provider for BRCA mutation carriers for annual skin examination and counselling regarding limiting UV exposure, the use of sunscreen and recognizing the early signs of melanoma might be warranted, but further studies are necessary., (© 2024. The Author(s).)

The subsurface is pivotal in the energy transition, for the sequestration of CO 2 and energy storage. It is crucial to understand to what extent geological faults may form leakage pathways that threaten the containment integrity of these projects. Fault flow behavior has been studied in the context of hydrocarbon development, supported by observations from wells drilled through faults, but such observations are rare in geoenergy projects. Focusing on mechanical behavior as early indicator of potential leakage risks, a probabilistic Coulomb Failure Stress workflow is developed and demonstrated using data from the Decatur CO 2 sequestration project to rank faults based on their containment risk. The analysis emphasizes the importance of fault throw relative to reservoir thickness and pore pressure change in assessing reactivation risks. Integrating this mechanical assessment with geological and dynamic fault analyses contributes to derisking fault containment for geoenergy applications, providing valuable insights for the successful development of subsurface storage projects., Competing Interests: K.B. is affiliated with Shell Global Solutions International B.V., A.W.C. is affiliated with Shell Global Solutions UK. Both authors declare they have no other affiliations., (© 2024 The Author(s).)

Objectives: To describe, and explain the rationale for, the methods used and decisions made during development of the updated SPIRIT 2024 and CONSORT 2024 reporting guidelines., Methods: We developed SPIRIT 2024 and CONSORT 2024 together to facilitate harmonization of the two guidelines, and incorporated content from key extensions. We conducted a scoping review of comments suggesting changes to SPIRIT 2013 and CONSORT 2010, and compiled a list of other possible revisions based on existing SPIRIT and CONSORT extensions, other reporting guidelines, and personal communications. From this, we generated a list of potential modifications or additions to SPIRIT and CONSORT, which we presented to stakeholders for feedback in an international online Delphi survey. The Delphi survey results were discussed at an online expert consensus meeting attended by 30 invited international participants. We then drafted the updated SPIRIT and CONSORT checklists and revised them based on further feedback from meeting attendees., Results: We compiled 83 suggestions for revisions or additions to SPIRIT and/or CONSORT from the scoping review and 85 from other sources, from which we generated 33 potential changes to SPIRIT (n = 5) or CONSORT (n = 28). Of 463 participants invited to take part in the Delphi survey, 317 (68%) responded to Round 1, 303 (65%) to Round 2 and 290 (63%) to Round 3. Two additional potential checklist changes were added to the Delphi survey based on Round 1 comments. Overall, 14/35 (SPIRIT n = 0; CONSORT n = 14) proposed changes reached the predefined consensus threshold (≥80% agreement), and participants provided 3580 free-text comments. The consensus meeting participants agreed with implementing 11/14 of the proposed changes that reached consensus in the Delphi and supported implementing a further 4/21 changes (SPIRIT n = 2; CONSORT n = 2) that had not reached the Delphi threshold. They also recommended further changes to refine key concepts and for clarity., Conclusion: The forthcoming SPIRIT 2024 and CONSORT 2024 Statements will provide updated, harmonized guidance for reporting randomized controlled trial protocols and results, respectively. The simultaneous development of the SPIRIT and CONSORT checklists has been informed by current empirical evidence and extensive input from stakeholders. We hope that this report of the methods used will be helpful for developers of future reporting guidelines., Competing Interests: Declaration of competing interest R. T. received support from the Medical Research Council–National Institute of Health and Care Research (MRC-NIHR). S. H. received support from MRC-NIHR. G. S. C. received support from MRC-NIHR. J. A. d. B. received support from MRC-NIHR. S. H., I. B., A.-W. C., A. H., K. F. S., and D. M. are members of the SPIRIT–CONSORT Executive Group. G. S. C. is director of the UK EQUATOR Centre. D. M. is director of the Canadian EQUATOR Centre. I. B. is deputy director of the French EQUATOR Centre. J. A. d. B. is a member of the UK EQUATOR Centre. D. M., A. H., and I. B. are members of the editorial board of the Journal of Clinical Epidemiology. Other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this article., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Within the current medical workforce, diversity is limited among surgical specialties. However, diversity allows physicians to provide culturally competent care. This paper discusses the trends in racial, ethnic, and gender representation within different surgical subspecialties with an emphasis on neurosurgery over a 20-year time frame., Methods: A retrospective review of data collected by the Accreditation Council for Graduate Medical Education over the past twenty years, as reported in Journal of the American Medical Association, was conducted. Residents from 5 surgical specialties were evaluated based on gender, race, and ethnic identifications from 2002 to 2022. One-way analysis of variance was performed to compare the levels and retention rates of racial, ethnic, and gender diversity within these specialties., Results: Analysis of resident demographics of the 5 surgical specialties reveals an overall trend of increasing diversity over the study period. Over the past 20 years, neurosurgery had an overall increase in Asian (+5.1%), Hispanic (+3.0%), and female (+11.4%) residents, with a decrease in White residents by 2.1% and Black residents by 1.1%. Among the surgical specialties analyzed, otolaryngology had the greatest overall increase in minority residents. Notably, there has been an overall increase in female residents across all 5 surgical specialties, with the highest in otolaryngology (+20.3%) which was significantly more than neurosurgery (P < 0.001)., Conclusions: This chronological analysis spanning 20 years demonstrates that neurosurgery, like other specialties, has seen a growth in several racial and ethnic categories. Relative differences are notable in neurosurgery, including Black, Asian, Hispanic, and White ethnic categories, with growth in females, but at a significantly lesser pace than seen in otolaryngology and plastic surgery., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Chemotherapy-induced nausea and vomiting (CINV) is a common toxicity that may impair the quality of life of patients with various malignancies ranging from early to end stages. In light of frequent changes to the guidelines for optimal management of CINV, we undertook this narrative review to compare the most recent guidelines published by ASCO (2020), NCCN (2023), MASCC/ESMO (2023), and CCO (2019). The processes undertaken by each organization to evaluate existing literature were also described. Although ASCO, NCCN, MASCC/ESMO, and CCO guidelines for the treatment and prevention of CINV share many fundamental similarities, the literature surrounding low and minimal emetic risk regimens is lacking. Current data regarding adherence to these guidelines is poor and warrants further investigation to improve care., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Health-related quality of life (HRQoL) measures are predictors of adverse health outcomes in older adults. Studies have demonstrated cross-sectional associations between HRQoL measures and blood-based biochemical markers. Acylcarnitines (ACs) are a class of metabolites generated in the mitochondria and are predictive of multiple geriatric syndromes. Changes in ACs reflect alterations in central carbon metabolic pathways. However, the prospective relationship between plasma ACs and declining HRQoL has not been examined. This study aimed to investigate both cross-sectional and longitudinal associations of baseline ACs with baseline and declining EuroQol-5 Dimension/EuroQol Visual Analogue Scale (EQ-5D/EQ-VAS) in community-dwelling older adults., Methods: One hundred and twenty community-dwelling older adults with EQ-5D/EQ-VAS measurements at baseline and follow-up were included. We quantified ACs at baseline using targeted plasma metabolomics profiling. Multivariate regressions were performed to examine cross-sectional and longitudinal associations between the measures., Results: Cross-sectionally, ACs showed no significant associations with either EQ-5D index or EQ-VAS scores. Longitudinally, multiple baseline short-chain ACs were significantly and inversely associated with declining EQ-5D index score, explaining up to 8.5% of variance in the decline., Conclusions: Within a cohort of community-dwelling older adults who had high HRQoL at baseline, we showed that higher levels of short-chain ACs are longitudinally associated with declining HRQoL. These findings reveal a novel association between central carbon metabolic pathways and declining HRQoL. Notably, dysregulation in mitochondrial central carbon metabolism could be detected prior to clinically important decline in HRQoL, providing the first evidence of objective biomarkers as novel predictors to monitor HRQoL in nonpharmacological interventions and epidemiology., (© The Author(s) 2022. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

The Consolidated Standards of Reporting Trials extension for Artificial Intelligence interventions (CONSORT-AI) was published in September 2020. Since its publication, several randomised controlled trials (RCTs) of AI interventions have been published but their completeness and transparency of reporting is unknown. This systematic review assesses the completeness of reporting of AI RCTs following publication of CONSORT-AI and provides a comprehensive summary of RCTs published in recent years. 65 RCTs were identified, mostly conducted in China (37%) and USA (18%). Median concordance with CONSORT-AI reporting was 90% (IQR 77-94%), although only 10 RCTs explicitly reported its use. Several items were consistently under-reported, including algorithm version, accessibility of the AI intervention or code, and references to a study protocol. Only 3 of 52 included journals explicitly endorsed or mandated CONSORT-AI. Despite a generally high concordance amongst recent AI RCTs, some AI-specific considerations remain systematically poorly reported. Further encouragement of CONSORT-AI adoption by journals and funders may enable more complete adoption of the full CONSORT-AI guidelines., (© 2024. The Author(s).)

Competing Interests: Conflicts of interest P.L. has received grants from the Lady Davis Institute for Medical Research, from the Jewish General Hospital Foundation and from the Jewish General Hospital Department of Medicine for this work. R.M. is the executive director of the Canadian Skin Patient Alliance, and receives funding from governments, individuals and corporations, including pharmaceutical companies. A full list of sponsors can be viewed here: https://www.canadianskin.ca/about-us/sponsors. A.P. is an inventor on two patents covering the use of peptidic transforming growth factor-β antagonists as antifibrotic agents.

Background: Developing strategies to prevent breast cancer-related arm lymphoedema (BCRAL) is a critical unmet need because there are no effective interventions to eradicate it once it reaches a chronic state. Certain strategies such as prospective surveillance programs and prophylactic lymphatic reconstruction have been reported to be effective in clinical trials. However, a large variation exists in practice based on clinician preference, organizational standards, and local resources., Methods: A two-round international Delphi consensus process was performed from February 27, 2023 to May 25, 2023 to compile opinions of 55 experts involved in the care and research of breast cancer and lymphoedema on such interventions., Findings: Axillary lymph node dissection, use of post-operative radiotherapy, relative within-arm volume increase one month after surgery, greater number of lymph nodes dissected, and high body mass index were recommended as the most important risk factors to guide selection of patients for interventions to prevent BCRAL. The panel recommended that prospective surveillance programs should be implemented to screen for and reduce risks of BCRAL where feasible and resources allow. Prophylactic compression sleeves, axillary reverse mapping and prophylactic lymphatic reconstruction should be offered for patients who are at risk for developing BCRAL as options where expertise is available and resources allow. Recommendations on axillary management in clinical T1-2, node negative breast cancer patients with 1-2 positive sentinel lymph nodes were also provided by the expert panel. Routine axillary lymph node dissection should not be offered in these patients who receive breast conservation therapy. Axillary radiation instead of axillary lymph node dissection should be considered in the same group of patients undergoing mastectomy., Interpretation: An individualised approach based on patients' preferences, risk factors for BCRAL, availability of treatment options and expertise of the healthcare team is paramount to ensure patients at risk receive preventive interventions for BCRAL, regardless of where they are receiving care., Funding: This study was not supported by any funding. RJC received investigator grant support from the Australian National Health and Medical Research Council (APP1194051)., Competing Interests: Elizabeth Dylke received support to attend Australasian Lymphology Association Symposium 2022 and 2023, and is the President and Director of Australasian Lymphology Association and Secretary of the Council of the Deans of Physiotherapy Australia and New Zealand; Yuichiro Kikawa received payment or honoraria for lectures, presentations, speaker bureaus, manuscript writing or education events from Eisai, Lilly, Chugai, Pfizer, Daiichi Sankyo and Novartis; Michael Lock received consulting fees from Bayer and Tersera, payment or honoraria for lectures, presentations, speaker bureaus, manuscript writing or education events from Knight Therapeutics, Abbvie and Eisai, and have stock options from Myovant; Icro Meattini received honoraria for lectures from Eli Lily, AstraZeneca, SeaGen, Gilead, Daiichi, Sankyo, Pfizer and Novartis; Tammy Mondry received consulting fees from Teladoc Health, and payment for honoraria from Klose Training; Abram Recht received grants or contracts from the Joint Centre for Radiation Therapy Foundation paid to his institution, received consulting fees from eviCore healthcare and EXACT Sciences Corporation, and has stock ownership of Imagine Scientific, Inc.; Jolien Robijns received grants or contracts from Kom op Tegen Kanker and Limburgs Kankerfonds paid to Hasselt University. All other authors declare no competing interests., (Crown Copyright © 2024 Published by Elsevier Ltd.)

Background: There is a well-documented risk of secondary cutaneous malignancies following allogeneic hematopoietic stem cell transplant (HSCT), but data on risk in pediatric populations are limited. The objective of this study is to perform a systematic review of reported features and outcomes of skin cancers in pediatric allogeneic HSCT recipients., Methods: MEDLINE, EMBASE, CINAHL, Cochrane, and Web of Science were systematically searched (Prospero CRD42022342139). Studies reporting cutaneous cancer outcomes were included if the age at transplant was ≤19 years. Titles, abstracts, and full-text articles were screened in duplicate., Results: Out of 824 citations that were screened, 12 articles were selected for analysis. The final sample included 67 pediatric HSCT recipients, comprising 65 allogeneic transplant recipients and 2 cases of HSCT with an unknown donor type. The median age at transplant and skin cancer diagnosis were 7.4 and 13 years, respectively. Out of the 67 pediatric HSCT recipients, some patients developed more than one lesion, resulting in 71 lesions. The most common skin cancer type was cutaneous squamous cell carcinoma (32 lesions), followed by basal cell carcinoma (25 lesions). The median latency period between HSCT and skin cancer diagnosis ranged from 0 to 29 years. Identified risk factors for skin cancers included younger age at the time of transplant, exposure to total body irradiation, prolonged post-transplant immunosuppression, graft versus host disease, and sunburn., Conclusion: Skin cancers are reported in pediatric allogeneic HSCT recipients, and the risk appears to be increased. More data are needed to better characterize this risk., (© 2023 The Authors. Pediatric Transplantation published by Wiley Periodicals LLC.)

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 )., (© 2024. The Author(s).)

Competing Interests: Conflicts of interest I.S. has received honoraria from Sanofi-Genzyme. R.M. is the executive director of the Canadian Skin Patient Alliance, which receives funding from governments, individuals and corporations, including pharmaceutical companies. A full list of sponsors can be viewed here: https://www.canadianskin.ca/about-us/sponsors. A.P. is an inventor on two patents covering the use of peptidic transforming growth factor-β antagonists as antifibrotic agents.

Competing Interests: Conflicts of interest R.M. is the executive director of the Canadian Skin Patient Alliance receiving funding from governments, individuals and corporations, including ­pharmaceutical ­companies. A full list of sponsors can be viewed here https://www.canadianskin.ca/about-us/sponsors. C.N. has received honoraria for advisory boards and talks by Merck, EMD Sorono, Novartis and Sanofi. A.B. is a coinventor on a patent covering the use of neddylation activating enzyme inhibitors as enhancers of RNA viruses. A.P. is an inventor on two patents covering the use of peptidic transforming growth factor-β antagonists as antifibrotic agents.