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  • Should Conferences Impose Uniform Reporting Guidelines for Research Abstracts?

    Should Conferences Impose Uniform Reporting Guidelines for Research Abstracts?
    Should Conferences Impose Uniform Reporting Guidelines for Research Abstracts

    Medical conferences are pivotal platforms for medical researchers from across the globe to disseminate discoveries, foster collaborations, and advance knowledge. Presentation of research findings at conferences is done in a format that best suits the nature of the research. For instance, a case report may benefit from a narrative approach, emphasizing the patient’s journey, while research on a new intervention may require a data-driven, factual presentation. Conferences organized across the globe often have different themes and focus points. However, this diverse nature of conferences and research reporting comes with a critical challenge: a lack of uniform reporting guidelines for research abstracts. This lacuna has been associated with significant challenges in the effectiveness of communication and evaluation of research presented at conferences, especially when research abstracts from different conferences are synthesized in the form of a systematic literature review (SLR).[1]

    Despite the advantages of flexibility in abstract presentation, the lack of standardized reporting guidelines presents obstacles. Ambiguous or incomplete abstracts hinder reviewers’ ability to assess research merit, potentially leading to biases in selection. Furthermore, inconsistent reporting makes it challenging to compare findings across studies, hindering knowledge synthesis and evidence-based practice. Another notable concern is the absence of a peer review process for abstracts that not only compromises the reliability and credibility of presented research but also poses important questions about the validity of findings and their applicability. These issues become particularly relevant in healthcare, where accurate and transparent reporting is critical for medical researchers seeking information for clinical practice and researchers conducting evidence syntheses like systematic reviews.[1]

    To address these challenges, the imposition of uniform reporting guidelines for research abstracts is a topic of debate within the scientific community. Striking the right balance between standardization and flexibility requires thoughtful consideration and collaboration between researchers, conference organizers, and professional bodies. Developing comprehensive guidelines that ensure essential information is accessible to reviewers and attendees while remaining adaptable to diverse conference themes and research disciplines is crucial.[1]

    One effective solution involves establishing core reporting elements that ensure abstract clarity and informativeness. Mandating specific sections for research objectives, methodology, key findings, and limitations creates a standardized framework. Scientific committees, comprised of researchers endorsing this core structure, can balance standardization and flexibility. Embracing technology is pivotal in this process, as online submission platforms equipped with tools to check adherence and standardized data templates tailored to different disciplines can streamline the abstract reporting process, ensuring consistent reporting.[2]

    Different reporting guidelines are already available to guide the reporting of research in journal manuscripts, each tailored to specific study designs. For example, PRISMA provides comprehensive guidance for systematic reviews, ensuring transparent and complete reporting of review methodologies and findings. PRISMA-A, an extension of the PRISMA Statement, specifically addresses systematic review abstracts, advocating for structured reporting aligned with PRISMA principles. CONSORT guidelines for RCTs offer a detailed framework for reporting randomized controlled trial (RCT) abstracts, emphasizing clarity, transparency, and completeness in presenting key study details. Various other reporting guidelines, such as STROBE, STARD, etc., are also available to enhance the comprehensiveness of other study designs. The increased usage of these guidelines to report research in manuscripts is largely attributable to the efforts of the ICMJE (International Committee of Medical Journal Editors), which has been instrumental in endorsing these guidelines as well as making the usage of these guidelines a mandatory process for authors who submit manuscripts to journals. This, in turn, has enhanced transparency and standardization in presenting findings in articles published in peer-reviewed journals.[3,4]

    A similar effort is required in developing and/ or promoting uniform reporting guidelines for abstracts in conferences. Embracing comparable practices in conferences will ensure that abstract reporting consistently maintains high standards, reinforcing the overall integrity of disseminating research across platforms. In this regard, akin to the role played by the ICMJE, it is the responsibility of various professional bodies to work towards the implementation of a uniform framework for research abstract presentations in different conferences across the world.[3,4]

    In conclusion, the debate on imposing uniform reporting guidelines for conference abstracts reflects the nuanced nature of scientific communication. While the advantages of flexibility are acknowledged, the drawbacks of inconsistent reporting must be addressed to ensure unbiased evaluation and effective knowledge synthesis. Embracing the various guidelines, technology, and educational initiatives can contribute to a transparent, credible, and communicative landscape for sharing research findings at conferences, ultimately advancing scientific progress.

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    References

    1. Saric L, Dosenovic S, Mihanovic J, Puljak L. Biomedical conferences’ author instructions rarely mention guidelines for reporting abstracts of trials and systematic reviews. Journal of Comparative Effectiveness Research. 2019 Dec;9(2):83-91.
    2. Beller EM, Glasziou PP, Altman DG, et al. PRISMA for abstracts: reporting systematic reviews in journal and conference abstracts. PLoS medicine. 2013 Apr 9;10(4):e1001419.
    3. Hopewell S, Clarke M, Moher D, et al. CONSORT for reporting randomised trials in journal and conference abstracts. The Lancet. 2008 Jan 26;371(9609):281-3.
    4. Mbuagbaw L, Thabane M, Vanniyasingam T, et al. Improvement in the quality of abstracts in major clinical journals since CONSORT extension for abstracts: a systematic review. Contemporary clinical trials. 2014 Jul 1;38(2):245-50.

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  • Living HTAs: Helping to Keep Health Technology Evidence in Real-Time

    Living HTAs: Helping to Keep Health Technology Evidence in Real-Time

    Health technology assessment (HTA) is a process that evaluates the safety, efficacy, and cost-effectiveness of medical technologies, such as drugs, medical devices, and diagnostic tests, in order to inform decision-making about their use in healthcare. It is a multidisciplinary approach that explores health technologies from clinical, economic, and the larger societal viewpoint. (1)

    Living HTA is a relatively new approach in the field of HEOR (health economics and outcomes research) in which the HTA methodology is applied in real-time or in a ‘living’, continuous manner, as opposed to traditional HTA that makes recommendations on an evidence base at a fixed point in time (2).

    Traditional HTA is analogous to a snapshot in time: any change in the set of potentially relevant interventions and comparators since the time of publication of the HTA report, or any methodological changes including updates in the structural assumptions of health economic models and the model inputs as well as the methods used to estimate the cost-effectiveness, can make the HTA report outdated. (3,4) These factors cumulatively create a significant risk of making incorrect decisions that may not deliver the promised value in healthcare. While certain HTA agencies update HTAs regularly if specific criteria are satisfied, these updates often take years, and at times the decision becomes outdated by the time these updates are published. (5) All these factors bring to the fore the importance of Living HTAs.

    Living HTA entails conducting frequent updates to the HTA, either manually or in a semi-automated manner. Each part of the HTA is rendered ‘alive’ in the living HTA by regularly applying updates and integrating different HTA elements, including literature searches, data extractions, updating the meta-analysis and cost-effectiveness model, and updating the entire HTA report. (2) There is no set interval for conducting living HTA, as it is typically an ongoing process that involves continuous monitoring and assessment of the technology in question. The frequency of conducting living HTA depends on the specific technology being assessed, the availability of new evidence, changes in the regulatory landscape, emergence of new technologies, as well as the context and objectives of the assessment.

    Manual living HTAs usually requires a team of committed researchers to update at specific points of the HTA process. It also necessitates the use of secure web-based user interfaces to exchange data across various processes to accomplish real-time live HTA. (2) Considering these challenges, and utilizing ongoing technological advances, researchers have explored automating certain aspects of living HTA to make the process simpler. These attempts include technologies to automate literature searching, trial identification, data extraction, performing systematic reviews, meta-analyses, and health-economic modelling, to name a few. Additionally, there have been attempts for automating HTA documentation as well.(6,7) However, automating the multiple steps involved in a HTA process is by itself a challenge since it requires adaptation of the model source code. Further, the process requires manual input from experienced HTA researchers to check the updates and ensure that the output from each stage is appropriate. Automation may also have ethical concerns, and may also lead to potential errors during the automation processes. Perhaps as a result of all these challenges, none of the HTA agencies at present have accepted automated procedures in HTA submissions.(6)

    There are a lot of challenges that the ‘Living HTA’ may face to cope-up with the increasing evidence base. Perhaps the most important challenge concerns new data: its availability, nature, access, and quality. Without sufficient data, it may be difficult to conduct an accurate and reliable assessment of the technology’s safety, efficacy, and cost-effectiveness. The next challenge pertains to the resource constrains: since living HTA is an ongoing process, the resource (monetary as well as manpower) demands are considerably higher. Next, there are concerns about data management, particularly for automated living HTA (which requires storing data in the cloud). There are also concerns surrounding the regulatory framework about HTA methodology, data requirements, and conditions for approval. Further, since Living HTA involves ongoing engagement with multiple stakeholders, including patients, healthcare providers, industry, and regulatory bodies, ensuring effective engagement and communication can be a challenge, particularly in cases where there are conflicting perspectives or priorities. Finally, HTA recommendations that change frequently may be difficult for the healthcare system to implement because, in practice, it takes time to procure and supply interventions that are newly deemed cost-effective and to decimate existing supplies of interventions that are no longer cost-effective. (6)

    Thus, while living HTA has the potential to provide more responsive, adaptive, accurate, and recent evidence for healthcare decision-making, it also requires careful consideration of various challenges to ensure that the assessment is accurate, reliable, and useful for guiding healthcare policy and practice.

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    References

    1. Oortwijn W, Jansen M, Baltussen R. Use of evidence-informed deliberative processes by health technology assessment agencies around the globe. International journal of health policy and management. 2020 Jan;9(1):27.
    2. Thokala P, Srivastava T, Smith R, et al. Living Health Technology Assessment: Issues, Challenges and Opportunities. Pharmacoeconomics. 2023 Jan 18:1–11. doi: 10.1007/s40273-022-01229-4. Epub ahead of print. PMID: 36652184; PMCID: PMC9848020.
    3. Garritty C, Tsertsvadze A, Tricco AC, et al. Updating systematic reviews: an international survey. PloS one. 2010 Apr 1;5(4):e9914.
    4. Gutiérrez-Ibarluzea I, Chiumente M, Dauben HP. The life cycle of health technologies. Challenges and ways forward. Frontiers in pharmacology. 2017 Jan 24;8:14.
    5. Kirwin E, Round J, Bond K, McCabe C. A conceptual framework for life-cycle health technology assessment. Value in Health. 2022 Jul 1;25(7):1116-23.
    6. Smith RA, Schneider PP, Mohammed W. Living HTA: Automating Health Economic Evaluation with R. Wellcome Open Research. 2022 Oct 11;7:194.
    7. Khalil H, Ameen D, Zarnegar A. Tools to support the automation of systematic reviews: a scoping review. Journal of Clinical Epidemiology. 2022 Apr 1;144:22-42.

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  • How to Improve Transparency with Real World Data to Support Market Access?

    How to Improve Transparency with Real World Data to Support Market Access?

    The USFDA defines real-world data (RWD) as ‘the data relating to patient health status and/or the healthcare delivery that is routinely collected from a variety of sources’, and real-world evidence (RWE) as ‘the clinical evidence regarding the usage and potential risks/benefits of a medical product obtained from analysis of RWD.’[1] RWD includes data from electronic health records (EHRs), administrative and medical claim databases, pharmacy data; data from product, patient, and disease registries, patient-generated data (including in-home use settings, social media data, patient forums, etc), and data gathered from other sources that can inform on health status.[1]

    RWD has been extensively used for pharmacovigilance in the form of phase 4 post-marketing surveillance studies. Lately, it is being realised that RWE and RWD can play additional role in the drug approval cycle. For example, the approval of Avelumab for the treatment of metastatic Merkel cell carcinoma (MCC) in March 2017 utilised electronic health record (EHR) data as historical control data for efficacy. Likewise, the approval of Lutetium Lu 177 dotatate for the treatment of certain neuroendocrine tumors in 2018 by the USFDA made extensive use of safety and efficacy data from the ERASMUS study, which was an expanded access study.[2]

    RWD has also been used for market access and to make reimbursement decisions in several countries. For example, in France, RWD collected during temporary authorization for use of a drug can be used to assess the price and level of reimbursement through health technology assessment (HTA). In the UK, RWD collected during early access to medicine scheme can be used as dossier of market access. In fact, the UK NHS has performed cost-effectiveness studies based on RWE and established a scheme to collect RWD for pharmacovigilance purposes. RWD are also used for pay-for-performance schemes in the USA.[3]

    Despite the raising importance of RWD in improving market access, a constant critique of RWD is that, since RWD is collected from routine healthcare, there is no set objective for RWD collection, unlike randomized controlled trials (RCTs) which generally have an objective and hypothesis. In other words, since RWE studies are secondary analysis of existing data that are collected unplanned (i.e., without a specific objective), they are susceptible to bias; this is not that prominent an issue for pre-planned studies of prospectively collected data (such as RCTs). Thus, there are high chances that RWE studies are more susceptible to results-driven design modifications than RCTs, thus bringing a question about transparency of RWD and the resulting RWE.[4]

    Data transparency improves the ability of decision-makers to assess the quality and validity of an RWE study by giving a deeper understanding of why and how the research was conducted and whether the results reflect pre-established questions and methods. It also facilitates the replication of results and an understanding of why findings of apparently similar studies differ. In line with these concepts, attempts are being made to improve RWD transparency, with an intention to strengthen the confidence that different stakeholders have on RWD, thereby further boost its usage for different aspects, including enhancing market access of drugs.[4]

    One such method for improving data transparency is by promoting registries for RWE studies. Though existing registries register and ClinicalTrials.gov) collect many features that are required for improving data transparency, they focus on primary data, and are not specific for RWD.[4] In 2017, International society for Pharmacoeconomics and Outcomes Research (ISPOR) and International Society for Pharmacoepidemiology (ISPE) formed a joint task force to identify good practices for addressing the concerns and to enhance confidence in evidence derived from RWE studies. The ISPOR-ISPE Special Task force recommends the researchers should declare the hypothesis to be tested, post study protocols and analysis publicly; and during publication attestation of any conformation or deviation from the initial study protocol.[4] In lines with the same, the ISPOR RWE registry was formally launched in October 2021, and represents a fit-for-purpose platform for registering RWE study designs prior to data collection, with an intention to facilitate RWD transparency and to elevate the trust in the study results; the RWE registry can be accessed at https://osf.io/registries/rwe/discover.

    Another method to improve RWD transparency is the concept of tokenization of healthcare data, by which different sources of patient-level RWD (for example; claims, EHR, registries, molecular biomarkers, and laboratories) can be linked to provide a complete, non-duplicate, and comprehensive understanding of the patient’s health. By providing an option to cross-check same patient data from different sources, tokenization can help improve the confidence in RWD from different sources.[5]

    RWD play enormous role in research and development process, they also help in estimating the risks and benefits of any treatment in real world scenarios. Enhancing RWD with transparency can go a long way in increasing its usage for market access.

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    References

    1. Framework for FDA’s real-world evidence program. Dec 2018. Available from: https://www.fda.gov/media/120060/download
    2. Feinberg BA, Gajra A, Zettler ME, et al. Use of real-world evidence to support FDA approval of oncology drugs. Value Health. 2020 Oct;23(10):1358-1365. 
    3. Pulini AA, Caetano GM, Clautiaux H, et al. Impact of real-world data on market authorization, reimbursement decision & price negotiation. Ther Innov Regul Sci. 2021;55(1):228-238.
    4. Orsini LS, Berger M, Crown W, et al. Improving transparency to build trust in real-world secondary data studies for hypothesis testing-why, what, and how: recommendations and a road map from the real-world evidence transparency initiative. Value Health. 2020 Sep;23(9):1128-1136. 
    5. Dagenais S, Russo L, Madsen A, et al. Use of real-world evidence to drive drug development strategy and inform clinical trial design. Clin Pharmacol Ther. 2022;111(1):77-89.

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