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BackgroundCritical appraisal aids in assessing the quality of scientific literature, which is central to the practice of evidence-based medicine. Several tools and guidelines are available for critiquing and assessing the quality of specific study types. However, limited guidance exists for critical appraisal of clinical pharmacokinetic studies.AimWe aimed to achieve experts’ consensus regarding the quality markers for clinical pharmacokinetic studies in an attempt to develop a critical appraisal tool.MethodQuality markers related to clinical pharmacokinetic studies, were derived from the published literature and categorized according to manuscript reporting domains (abstract, introduction/background, methodology, results, discussion, and conclusion). Questions that aid in appraising pharmacokinetic studies were formulated from these quality markers. Experts were involved in a modified Delphi process to achieve a consensus regarding the formulated questions. The proposed tool was pilot tested on 30 recently published clinical pharmacokinetic studies. Inter-observer agreement was measured to determine the reliability of the included items.ResultsTwenty-five experts consented to participate. Three rounds of a modified Delphi survey were required to generate a consensus for a 21-item tool aimed at appraising the quality of clinical pharmacokinetic studies. When applied to 30 recently published clinical pharmacokinetic studies, most items scored fair to moderate levels of agreement (61.90–95.24%).ConclusionThe clinical pharmacokinetic critical appraisal tool (CACPK) developed in this study consisted of 21 items aimed at helping an end-user to determine the quality of a pharmacokinetic study. Further studies are warranted to reaffirm the validity and reliability of the CACPK tool.

Evidence-based research (EBR) has become a cornerstone in the scientific, medical, and social sciences disciplines, informing decision-making processes and advancing knowledge across various fields. Evidence-based practice emphasizes integration of EBR, clinical expertise, and patient preferences to guide clinical practice. However, the mere existence of research evidence is not enough; it is essential to critically appraise the evidence to ensure its reliability, validity, and relevance to the context in which it is applied. Critical appraisal involves systematically evaluating the design, methodology, results, and conclusions of a research study to assess its quality and applicability. This article will provide an in-depth insight about reporting and critical appraisal of EBR, examining the principles of critical appraisal, available tools for reporting and appraising a research paper, challenges faced in critical appraisal, and how to make the most of the journal club.

Health care professionals are increasingly required to base clinical decisions on the best available evidence. Evidence based medicine (EBM) is a systematic approach to clinical problem solving which allows the integration of the best available research evidence with clinical expertise and patient values. This paper explains the concept of EBM and introduces the five step EBM model: formulation of answerable clinical questions; searching for evidence; critical appraisal; applicability of evidence; evaluation of performance. Subsequent articles will focus on the principles and critical appraisal of randomised controlled trials, systematic reviews, and meta-analyses, and provide a practical demonstration of the five step EBM model using a real life clinical scenario.

ObjectivesThe aim of this study was to develop a critical appraisal (CA) tool that addressed study design and reporting quality as well as the risk of bias in cross-sectional studies (CSSs). In addition, the aim was to produce a help document to guide the non-expert user through the tool.DesignAn initial scoping review of the published literature and key epidemiological texts was undertaken prior to the formation of a Delphi panel to establish key components for a CA tool for CSSs. A consensus of 80% was required from the Delphi panel for any component to be included in the final tool.ResultsAn initial list of 39 components was identified through examination of existing resources. An international Delphi panel of 18 medical and veterinary experts was established. After 3 rounds of the Delphi process, the Appraisal tool for Cross-Sectional Studies (AXIS tool) was developed by consensus and consisted of 20 components. A detailed explanatory document was also developed with the tool, giving expanded explanation of each question and providing simple interpretations and examples of the epidemiological concepts being examined in each question to aid non-expert users.ConclusionsCA of the literature is a vital step in evidence synthesis and therefore evidence-based decision-making in a number of different disciplines. The AXIS tool is therefore unique and was developed in a way that it can be used across disciplines to aid the inclusion of CSSs in systematic reviews, guidelines and clinical decision-making.

PurposeA substantial, albeit scattered, body of research evidence is accumulating in the cause-related marketing (CRM) research stream. Thus, there is a need of a systematic overview of extant literature to map and holistically understand the CRM domain.Design/methodology/approachTo address this issue and make progress in this important area, the authors systematically review and critically examine the state of academic research on CRM.FindingsBased on a systematic review of 105 journal articles published over the past 30 years, the results reveal that CRM research is a vibrant and rapidly growing domain in the broader marketing field. This assessment exercise also shows that the current state of knowledge about CRM is characterized by persisting knowledge gaps, conflicting empirical results, theoretical inconsistencies, as well as by the absence of international marketing research on the CRM domain.Originality/valueTherefore, the authors critically evaluate the extant CRM research with the aim of increasing its coherence, quality, scope, impact and international dimension. Based on this evaluation, the authors develop an ambitious research agenda that addresses a number of promising research paths embracing different international perspectives. Finally, the authors discuss the contributions to the literature and the implications for both academics and practitioners.

Risk-of-bias assessment is a central component of systematic reviews, but little conclusive empirical evidence exists on the validity of such assessments. In the context of such uncertainty, we present pragmatic recommendations that promote transparency and reproducibility in processes, address methodological advances in the risk-of-bias assessment, and can be applied consistently across review topics. Epidemiological study design principles; available empirical evidence, risk-of-bias tools, and guidance; and workgroup consensus. We developed recommendations for assessing the risk of bias of studies of health-care interventions specific to framing the focus and scope of risk-of-bias assessment; selecting the risk-of-bias categories; choosing assessment instruments; and conducting, analyzing, and presenting results of risk-of-bias assessments. Key recommendations include transparency and reproducibility of judgments, separating risk of bias from other constructs such as applicability and precision, and evaluating the risk of bias per outcome. We recommend against certain past practices, such as focusing on reporting quality, relying solely on study design or numerical quality scores, and automatically downgrading for industry sponsorship. Risk-of-bias assessment remains a challenging but essential step in systematic reviews. We presented standards to promote transparency of judgments.

Recently there has been a significant increase in the number of systematic reviews addressing questions of prevalence. Key features of a systematic review include the creation of an a priori protocol, clear inclusion criteria, a structured and systematic search process, critical appraisal of studies, and a formal process of data extraction followed by methods to synthesize, or combine, this data. Currently there exists no standard method for conducting critical appraisal of studies in systematic reviews of prevalence data. A working group was created to assess current critical appraisal tools for studies reporting prevalence data and develop a new tool for these studies in systematic reviews of prevalence. Following the development of this tool it was piloted amongst an experienced group of sixteen healthcare researchers. The results of the pilot found that this tool was a valid approach to assessing the methodological quality of studies reporting prevalence data to be included in systematic reviews. Participants found the tool acceptable and easy to use. Some comments were provided which helped refine the criteria. The results of this pilot study found that this tool was well-accepted by users and further refinements have been made to the tool based on their feedback. We now put forward this tool for use by authors conducting prevalence systematic reviews.

Vaccine effectiveness (VE) studies are essential for informing immunization policy and public health decision-making. However, the observational nature of most VE studies introduces unique methodological challenges, including biases that are not adequately addressed by existing risk-of-bias (RoB) tools. The Risk of Bias in Vaccine Effectiveness (RoB-VE) project is an international, multiphase methodological research initiative aimed at improving the quality, transparency, interpretability, and reporting of VE research. Funded by the Canadian Institutes of Health Research and supported by many global partners, the project seeks to generate a comprehensive toolkit for VE studies. This includes an RoB assessment resource tailored to VE study designs and a complementary reporting guideline to enhance consistency in VE study reporting. The project follows an evidence-informed approach, beginning with a review of the literature to inform tool development, and progressing through interest holder engagement, modified Delphi consensus, usability testing, and beta validation. This introductory paper outlines the rationale, scope, and methodology of the RoB-VE project. These efforts aim to strengthen the methodological foundation of VE research and support more reliable evidence synthesis and policy development. VE studies measure how well vaccines work in real-world scenarios. These studies are essential for shaping vaccination recommendations. To assess the validity of VE studies, it is necessary to carry out an RoB assessment, which involves looking at different aspects of the study (eg, data collection methods, how participants are recruited, etc.) that have the potential to yield misleading results. Existing RoB assessment tools do not fully capture issues particularly relevant to VE studies and inconsistent reporting limits their usefulness. To address this, we are conducting the RoB-VE project. This project aims to improve the quality, transparency, interpretability, and reporting of VE research through the development, validation, and dissemination of a robust and user-friendly RoB assessment tool, specifically tailored for assessing VE studies. Our methodology involves a comprehensive multistep process based on established approaches. A broad range of international participants with diverse expertise and profiles will be engaged along the way to refine and finalize the tool. After pilot testing the beta version of the tool and making further refinements, we aim to deliver version 1 of the tool, which will undergo a large-scale application phase to assess its reliability and usefulness. Additionally, we will develop a reporting guideline to enhance the completeness of reporting of VE studies. This introductory paper outlines the rationale, scope, and methodology of the RoB-VE project. This project will elevate the standards of evidence synthesis, ultimately contributing to more reliable, transparent, and impactful research in the critical field of VE evaluation. •Our team has launched the Risk of Bias in Vaccine Effectiveness (RoB-VE) project.•VE evaluation relies on various designs prone to unique bias sources and mechanisms.•A risk-of-bias tool and reporting guideline specific to the context of VE are needed.•We will develop a VE research toolkit using a multistep, evidence-informed approach.

Data continue to accumulate indicating that many systematic reviews are methodologically flawed, biased, redundant, or uninformative. Some improvements have occurred in recent years based on empirical methods research and standardization of appraisal tools; however, many authors do not routinely or consistently apply these updated methods. In addition, guideline developers, peer reviewers, and journal editors often disregard current methodological standards. Although extensively acknowledged and explored in the methodological literature, most clinicians seem unaware of these issues and may automatically accept evidence syntheses (and clinical practice guidelines based on their conclusions) as trustworthy. A plethora of methods and tools are recommended for the development and evaluation of evidence syntheses. It is important to understand what these are intended to do (and cannot do) and how they can be utilized. Our objective is to distill this sprawling information into a format that is understandable and readily accessible to authors, peer reviewers, and editors. In doing so, we aim to promote appreciation and understanding of the demanding science of evidence synthesis among stakeholders. We focus on well-documented deficiencies in key components of evidence syntheses to elucidate the rationale for current standards. The constructs underlying the tools developed to assess reporting, risk of bias, and methodological quality of evidence syntheses are distinguished from those involved in determining overall certainty of a body of evidence. Another important distinction is made between those tools used by authors to develop their syntheses as opposed to those used to ultimately judge their work. Exemplar methods and research practices are described, complemented by novel pragmatic strategies to improve evidence syntheses. The latter include preferred terminology and a scheme to characterize types of research evidence. We organize best practice resources in a Concise Guide that can be widely adopted and adapted for routine implementation by authors and journals. Appropriate, informed use of these is encouraged, but we caution against their superficial application and emphasize their endorsement does not substitute for in-depth methodological training. By highlighting best practices with their rationale, we hope this guidance will inspire further evolution of methods and tools that can advance the field.