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Background: Due to limited diagnostic capacity and availability of point-of-care tests, diagnosis of Clade I mpox in the geographical regions most affected is usually on clinical grounds. This may be complicated due to the similarity between mpox and varicella (chickenpox) lesions. Visual assessment of lesions is also used for determining clinical progress and to assess patient outcomes in clinical trials. However, there has been no investigation into whether clinicians can (i) identify Clade I mpox compared to other viral lesions (ii) differentiate between Clade I mpox lesion stages. Methodology/Principle findings: The objective of this study was to evaluate inter-rater reliability and agreement between clinicians assessing lesions in patients with Clade I mpox. We presented experienced clinicians with 17 images of Clade I mpox or varicella and asked them to independently indicate the most likely diagnosis–mpox or varicella–and to categorise the lesions according to their stage. When selecting the most likely diagnosis, accuracy varied across all images, the inter-rater reliability was poor (κ = 0.223; z = 10.1) and agreement was moderate (Po = 68%). When categorising lesions according to their type, if a single lesion type was present in the image, inter-rater reliability was moderate (κ = 0.671, z = 40.6) and agreement was good (Po = 78%), but when multiple lesion types were shown in an image, both inter-rater reliability (κ = 0.153, z = 10.5) and agreement (Po = 29%) decreased substantially. Conclusions: This study demonstrates that there are presently limitations in using visual assessment to diagnose Clade I mpox and evaluate lesion stage and treatment outcomes, which have an impact on clinical practice, public health and clinical trials. More robust indicators and tools are required to inform clinical, public-health, and research priorities, but these must be implementable in countries affected by mpox. Author summary: Mpox is a zoonotic illness caused by the monkeypox virus (MPXV), for which there are two distinct sub-clades. Clade I is typically found in central Africa and is associated with worse patient outcomes than Clade II. Diagnosis of mpox is most commonly performed using PCR, but in settings with limited laboratory capacity diagnosis is usually performed on clinical grounds taking lesion presentation in to account. Lesion presentation is also used to assess patient outcomes in both clinical and research settings. However, there has been no investigation into whether clinicians can (i) identify Clade I mpox compared to other viral lesions (ii) differentiate between Clade I mpox lesion stages, which has important implications for clinical practice, research and public health. Our study, which presented 16 clinicians with 17 sets of images of Clade I mpox or varicella and asked them to i) provide the most likely diagnosis and ii) categorise the lesions in to their stages, demonstrates that there are presently limitations in using visual assessment to diagnose Clade I mpox and evaluate lesion stage and treatment outcomes. Alternative methods and tools are therefore required that can be easily implemented in affected countries. [ABSTRACT FROM AUTHOR]

Background: Monkeypox is a viral zoonotic disease commonly reported in humans in parts of Central and West Africa. This protocol is for an Expanded Access Programme (EAP) to be implemented in the Central African Republic, where Clade I monkeypox virus diseases is primarily responsible for most monkeypox infections. The objective of the programme is to provide patients with confirmed monkeypox with access to tecovirimat, a novel antiviral targeting orthopoxviruses, and collect data on clinical and virological outcomes of patients to inform future research. Methods: The study will be conducted at participating hospitals in the Central African Republic. All patients who provide informed consent to enrol in the programme will receive tecovirimat. Patients will remain in hospital for the duration of treatment. Data on clinical signs and symptoms will be collected every day while the patient is hospitalised. Blood, throat and lesion samples will be collected at baseline and then on days 4, 8, 14 and 28. Patient outcomes will be assessed on Day 14 –end of treatment–and at Day 28. Adverse event and serious adverse event data will be collected from the point of consent until Day 28. Discussion: This EAP is the first protocolised treatment programme in Clade I MPXV. The data generated under this protocol aims to describe the use of tecovirimat for Clade I disease in a monkeypox endemic region of Central Africa. It is hoped that this data can inform the definition of outcome measures used in future research and contribute to the academic literature around the use of tecovirimat for the treatment of monkeypox. The EAP also aims to bolster research capacity in the region in order for robust randomised controlled trials to take place for monkeypox and other diseases. Trial registration: {2a & 2b}: ISRCTN43307947. [ABSTRACT FROM AUTHOR]

The article focuses on the importance of community involvement in addressing the mpox outbreak. Topics include the potential negative impact of classifying mpox as an STI on stigma, the need for community input in discussions about mpox, and the value of including affected communities in response efforts, as exemplified by a UK clinical treatment trial.

The article discusses the lack of progress in preventing and treating mpox, a virus that has caused 91,000 cases worldwide. There are significant inequalities in access to therapy and vaccination between high-income and low- and middle-income countries, particularly in Africa. The article highlights the challenges of conducting effective clinical research during short-lived outbreaks and the need for safe and effective treatments. It also emphasizes the importance of international collaborations, efficient regulatory processes, and equitable access to medical interventions. The article calls for action from all stakeholders to address these issues and improve clinical research in outbreak response. [Extracted from the article]

• There are challenges in categorizing mpox lesions. • We assessed the inter-rater reliability and agreement among clinicians. • We found moderate reliability and agreement in mpox lesion assessment. • This study has implications for interpreting trial results. • There is a need for standardized lesion classification in clinical trials. The ongoing global outbreak of mpox, caused by clade IIb mpox virus, poses significant challenges in accurately categorizing and assessing the diversity of lesions. With lesion resolution being a key endpoint in clinical trials and observational studies, it is essential to evaluate the inter-rater reliability and agreement of clade IIb mpox lesion assessment among clinicians. Clinicians experienced in clade IIb mpox disease were surveyed online with 20 lesion images. They categorized lesions into active, crusted, resolved, or unclassifiable groups. Reliability was assessed with Fleiss' kappa and agreement with proportion of exact agreement. Fifty-three clinicians completed the survey, with a median self-reported confidence rating of 7 (on a scale of 1 to 10) in assessing mpox lesions. The inter-rater reliability was found to be moderate, with a Fleiss' kappa coefficient of 0.417 (P <0.05, 95% confidence interval: 0.409-0.425). The inter-rater agreement was 61%. This study demonstrates moderate inter-rater reliability and agreement in clade IIb mpox lesion assessment among clinicians. The findings emphasize the importance of standardizing lesion classification systems to facilitate clinical care (e.g., decision to start treatment) and public health (e.g. isolation) decisions and a need to explore alternative endpoints for clinical trials. [ABSTRACT FROM AUTHOR]