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Wealthy nations must step up support for Africa and vulnerable countries in addressing past, present and future impacts of climate change The 2022 report of the Intergovernmental Panel on Climate Change (IPCC) paints a dark picture of the future of life on earth, characterised by ecosystem collapse, species extinction, and climate hazards such as heatwaves and floods.1 These are all linked to physical and mental health problems, with direct and indirect consequences of increased morbidity and mortality. To avoid these catastrophic health effects across all regions of the globe, there is broad agreement—as 231 health journals argued together in 2021—that the rise in global temperature must be limited to less than 1.5oC compared with pre-industrial levels. While the Paris Agreement of 2015 outlines a global action framework that incorporates providing climate finance to developing countries, this support has yet to materialise.2 COP27 is the fifth Conference of the Parties (COP) to be organised in Africa since its inception in 1995. Ahead of this meeting, we—as health journal editors from across the continent—call for urgent action to ensure it is the COP that finally delivers climate justice for Africa and vulnerable countries. This is essential not just for the health of those countries, but for the health of the whole world.

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Proposed Changes to Disclosures from the ICMJE The International Committee of Medical Journal Editors proposes several changes to the disclosure process in a joint editorial. Feedback on the propos...

SARS-CoV-2 is one of seven coronaviruses known to infect humans. Other than SARS-CoV-2, the other coronaviruses causing SARS and MERS are deadly, the rest are relatively benign causing only common colds in the vast majority of cases. SARS-CoV-2 indiscriminately infecting people with varying severity across geographies, genders, and occupations. Despite this indiscriminate attack, experiences and studies indicate that children are mildly affected in comparison to adults, representing approximately 5% of cases and less than 1% of admissions to hospital (1, 2). The proportion of severe and critical cases was 10.6%, 7.3%, 4.2%, 4.1%, and 3.0% for the age group of ˂1, 1-5, 6-10, 11-15 and >15 years, respectively (1). SARS and MERS showed similar pater where kids are largely spared from severe diseases. Swine flu (H1N1) virus, responsible for the flu pandemic of 2009 and 2010 preferentially had tummy symptoms on children.It became mysterious why children are less sick after being infected where more than 90 percent of pediatric cases presenting as moderate, mild, or without symptoms entirely. “Why most of the children’s COVID-19 cases were less severe than adults’ cases is puzzling. Scientists and clinicians need to learn more about this virus and the immune response against it at different age groups. Untying the mystery why SARS-CoV-2 is less severe in children could help to design new ways to combat the spread of the disease.Different literatures forwarded the following ideas to explain why children develop mild COVID-19 disease.1. Vulnerability to ARDS: though small number of cases pass through all phases, COVID-19 disease is having three distinct phases namely the viral phase, the pulmonary phase, and the hyperinflammatory phase. It is during the hyperinflammatory phase cases are likely to develop severe complications like acute respiratory distress syndrome (ARDS). However, studies showed that children are not less prone to developing ARDS during respiratory tract infections; in fact, during the H1N1 flu pandemic, being under the age of one year was a significant risk factor for developing a severe form of ARDS (3,4). Therefore, this argument cannot hold true.2. The immune system’s delicate balance: One of the reasons for the milder COVID-19 disease presentation in children compared to adult may be due to a qualitatively different response to the SARS-CoV2 virus (5). With increasing age, children’s immune systems may reach a sort of just-right status, growing strong enough to keep an infection in check without overreacting.3. Prior Exposure to other similar viruses: children are exposed to various similar viral infection while they are in kindergarten and school. Prior exposure to other milder viruses may contribute for children’s less severe COVID-19 disease. It is shown that disease development and subsequent severity is dose dependent as it is shown in other studies (6). The presence of other viruses in the airways of children could limit the growth of SARS-CoV2 by direct virus-to-virus interactions and competition (7).4. Expression level of Binding Proteins: Similar to that of SARS-CoV-1, SARS-CoV-2 establishes infection by glomming on to a protein called angiotensin-converting enzyme (ACE)2 which is found on the surfaces of cells throughout the body (8). Differences in the expression levels of the ACE-2 receptor between children and adults could contribute for the less severe disease in children. Some researchers have hypothesized that kids’ lung cells could make fewer—or perhaps even differently shaped-ACE2 proteins. This is an example of the fact that the immune systems of children and adults are different, both with respect to their composition and functional responsiveness (9).To note, although children tend to have mild forms of COVID-19, protective measures should be taken to prevent them from becoming infected. This is important for mitigating the pandemic, as not only can children transmit viruses even when presenting mild forms of the disease, but they have been shown to harbour large amounts of the virus even without showing symptoms (10). It is important to remember that viruses can persist in faeces long after they are gone in nasopharyngeal secretions.Understanding the milder COVID-19 disease in children will provide important information about the disease. It may also suggest important protective mechanisms and targets for future therapies.

The International Committee of Medical Journal Editors (ICMJE) believes there is an ethical obligation to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk. In January 2016 we published a proposal aimed at helping to create an environment in which the sharing of deidentified individual participant data becomes the norm. In response to our request for feedback we received many comments from individuals and groups. (1) Some applauded the proposals while others expressed disappointment they did not more quickly create a commitment to data sharing. Many raised valid concerns regarding the feasibility of the proposed requirements, the necessary resources, the real or perceived risks to trial participants, and the need to protect the interests of patients and researchers. It is encouraging that data sharing is already occurring in some settings. Over the past year, however, we have learned that the challenges are substantial and the requisite mechanisms are not in place to mandate universal data sharing at this time. Although many issues must be addressed for data sharing to become the norm, we remain committed to this goal. Therefore, ICMJE will require the following as conditions of consideration for publication of a clinical trial report in our member journals: i) As of July 1, 2018 manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement as described below. ii) Clinical trials that begin enrolling participants on or after January 1, 2019 must include a data sharing plan in the trials registration. The ICMJE's policy regarding trial registration is explained at www.icmje.org/recommendations/browse/ publishing-and-editorial-issues/clinical-trial-registration.html. If the data sharing plan changes after registration this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record. Data sharing statements must indicate the following: whether individual deidentified participant data (including data dictionaries) will be shared; what data in particular will be shared; whether additional, related documents will be available (e.g. study protocol, statistical analysis plan, etc.); when the data will become available and for how long; by what access criteria data will be shared (including with whom, for what types of analyses and by what mechanism). Illustrative examples of data sharing statements that would meet these requirements are in the Table 1. These initial requirements do not yet mandate data sharing, but investigators should be aware that editors may take into consideration data sharing statements when making editorial decisions. These minimum requirements are intended to move the research enterprise closer to fulfilling our ethical obligation to participants. Some ICMJE member journals already maintain, or may choose to adopt, more stringent requirements for data sharing. Sharing clinical trial data is one step in the process articulated by the World Health Organization (WHO) and other professional organizations as best practice for clinical trials: universal prospective registration; public disclosure of results from all clinical trials (including through journal publication); and data sharing. Although universal compliance with the requirement to prospectively register clinical trials has not yet been achieved and requires continued emphasis, we must work towards fulfilling the other steps of best practice as well-including data sharing. As we move forward into this new norm where data are shared, greater understanding and collaboration among funders, ethics committees, journals, trialists, data analysts, participants, and others will be required. We are currently working with members of the research community to facilitate practical solutions to enable data sharing. …

A requirement of the International Committee of Medical Journal Editors

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The International Committee of Medical Journal Editors (ICMJE) is a group of general medical journal editors meeting regularly and works on Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals (www.ICMJE.org). In doing so it receives comments and suggestions from editors, researchers, associations and funding companies. The committee members are journal editors from all parts of the world and representatives of the World Association of Medical Editors (WAME), National Library of Medicine (NLM) and Council of Science Editors (CSE). Other journals opt to follow the ICMJE's Uniform Requirements for Manuscripts Submitted to Biomedical Journals can apply to include their journal on the list of journals that follow ICMJE policy on www.ICMJE.org. Until now over two thousand five hundred journals are in the list. However, many authors submitting manuscripts to publish on those journals claiming to follow the ICMJE uniform requirements appear un-aware of the Recommendations. As a result, they submit manuscripts which are prepared in the contrary. Likewise, despite their cognizance, many of these journals claiming following the ICMJE Uniform Requirements do not enforce utilization of the requirements. This could lead to unnecessary origin of conflict by some authors and funding organizations requesting ICMJE to take measures on such journals. However, researchers, editors and funders should know that ICMJE is not a mandated organization to take such measures; rather as a volunteer group recommends what best research and publication practice should be. Unless it is unfamiliarity, following the ICMJE requirements do not create inconvenience or incur cost. Therefore, researchers who intend to publish on journals that follow the ICMJE Uniform Requirements are advised to read the ICMJE Recommendations and other documents on www.ICMJE.org so that they can prepare their manuscript accordingly. Journals which follow the ICMJE requirements better set means of checking submitted manuscripts for compliance to the ICMJE requirements before they accept and publish them. The current issue (Vol. 26, No 1), the first issue of the year contains two editorials focusing on the ICMJE recommendations, ten original articles on varied subjects and three case reports focusing on different areas. The first editorial is a sort of awareness creation and briefing about the already available ICMJE recommendations while the second one is on Clinical Trial Data sharing which is developed newly and posted for comment. Two of the original researches published in this issue are on newborn care, two on HIV/AIDS, one each on maternal health, headache, burn injury, kidney injury, traditional medicine and tuberculosis from geographically varied low and middle income countries. The three case reports are on various diagnostic and therapeutic challenging conditions. I invite readers to read through these articles and appreciate or utilize the contents. I also encourage readers to forward comments and suggestions.

The International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk. In a growing consensus, many funders around the world—foundations, government agencies, and industry—now mandate data sharing. Here we outline ICMJE’s proposed requirements to help meet this obligation. We encourage feedback on the proposed requirements. Anyone can provide feedback at www.icmje.org by 18 April 2016. The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Further details may be found in the Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals at www.icmje.org As a condition of consideration for publication of a clinical trial report in our member journals, the ICMJE proposes to require authors to share with others the deidentified individual-patient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material) no later than 6 months after publication. The data underlying the results are defined as the IPD required to reproduce the article’s findings, including necessary metadata. This requirement will go into effect for clinical trials that begin to enroll participants beginning 1 year after the ICMJE adopts its data-sharing requirements.* Enabling responsible data sharing is a major endeavor that will affect the fabric of how clinical trials are planned and conducted and how their data are used. By changing the requirements of the manuscripts we will consider for publication in our journals, editors can help foster this endeavor. As editors, our direct influence is logically, and practically, limited to those data underpinning the results and analyses we publish in our journals. The ICMJE also proposes to require that authors include a plan for data sharing as a component of clinical trial registration. This plan must include where the researchers will house the data and, if not in a public repository, the mechanism by which they will provide others access to the data, as well as other data-sharing plan elements outlined in the 2015 Institute of Medicine Report (e.g., whether data will be freely available to anyone upon request or only after application to and approval by a learned intermediary, whether a data use agreement will be required) (1). ClinicalTrials.gov has added an element to its registration platform to collect data-sharing plans. We encourage other trial registries to similarly incorporate mechanisms for the registration of data-sharing plans. Trialists who want to publish in ICMJE member journals (or nonmember journals that choose to follow these recommendations) should choose a registry that includes a data-sharing plan element as a specified registry item or allows for its entry as a free-text statement in a miscellaneous registry field. As a condition of consideration for publication in our member journals, authors will be required to include a description of the data-sharing plan in the submitted manuscript. Authors may choose to share the deidentified IPD underlying the results presented in the article under less restrictive, but not more restrictive, conditions than were indicated in the registered data-sharing plan. ICMJE already requires the prospective registration of all clinical trials prior to enrollment of the first participant. This requirement aims, in part, to prevent selective publication and selective reporting of research outcomes, and to prevent unnecessary duplication of research effort. Including a commitment to a data-sharing plan is a logical addition to trial registration that will further each of these goals. Prospective trial registration currently includes documenting the planned primary and major secondary end points to be assessed, which enables identification of incomplete reporting as well as post hoc analyses. Declaring the plan for sharing data prior to their collection will further enhance transparency in the conduct and reporting of clinical trials by exposing when data availability following trial completion differs from prior commitments. Sharing clinical trial data, including deidentified IPD, requires planning to ensure appropriate ethics committee or institutional review board approval and the informed consent of study participants. Accordingly, we will defer these requirements for 1 year to allow investigators, trial sponsors, and regulatory bodies time to plan for their implementation. Just as the confidentiality of trial participants must be protected (through the deidentification of IPD), and the needs of those reasonably requesting data met (through the provision of useable data), the reasonable rights of investigators and trial sponsors must also be protected. ICMJE proposes the following to safeguard these rights. First, ICMJE editors will not consider the deposition of data in a registry to constitute prior publication. Second, authors of secondary analyses using these shared data must attest that their use was in accordance with the terms (if any) agreed to upon their receipt. Third, they must reference the source of the data using a unique identifier of a clinical trial’s data set to provide appropriate credit to those who generated it and allow searching for the studies it has supported. Fourth, authors of secondary analyses must explain completely how theirs differ from previous analyses. In addition, those who generate and then share clinical trial data sets deserve substantial credit for their efforts. Those using data collected by others should seek collaboration with those who collected the data. However, because collaboration will not always be possible, practical, or desired, an alternative means of providing appropriate credit needs to be developed and recognized in the academic community. We welcome ideas about how to provide such credit. Data sharing is a shared responsibility. Editors of individual journals can help foster data sharing by changing the requirements of the manuscripts they will consider for publication in their journals. Funders and sponsors of clinical trials are in a position to support and ensure adherence to IPD sharing obligations. If journal editors become aware that IPD sharing obligations are not being met, they may choose to request additional information; to publish an expression of concern; to notify the sponsors, funders, or institutions; or in certain cases, to retract the publication. In the rare situation in which compliance with these requirements is impossible, editors may consider authors’ requests for exceptions. If an exception is made, the reason(s) must be explained in the publication. Sharing data will increase confidence and trust in the conclusions drawn from clinical trials. It will enable the independent confirmation of results, an essential tenet of the scientific process. It will foster the development and testing of new hypotheses. Done well, sharing clinical trial data should also make progress more efficient by making the most of what may be learned from each trial and by avoiding unwarranted repetition. It will help to fulfill our moral obligation to study participants, and we believe it will benefit patients, investigators, sponsors, and society.

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