REporting quality of PilOt randomised controlled trials in surgery (REPORTS): a methodological survey protocol.

INTRODUCTION: The aim of this methodological review is to evaluate the completeness of reporting of surgical pilot and feasibility randomised trials as per the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials. Moreover, we aim to assess for the presence of spin reporting and inconsistency between abstract and main text reporting in surgical pilot and feasibility randomised trials. METHODS AND ANALYSIS: A comprehensive, electronic search strategy will be used to identify studies indexed in Medline, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) databases. Studies will be included if they are pilot or feasibility randomised trials of surgical interventions. The primary outcome will be overall CONSORT statement extension to randomised pilot and feasibility trials checklist completeness. This will be defined as trials reporting each of the 40 items in the CONSORT statement extension to randomised pilot and feasibility trials checklist. Secondary outcomes will include the reporting of individual studies as per the CONSORT extension to randomised pilot and feasibility trials, the use of spin reporting strategies, trial factors associated with reporting quality and spin strategy use, and consistency between abstract and main text reporting. Poisson and logistic regressions will be performed to explore the association between trial factors and completeness of reporting as measured by the number of reported CONSORT items. ETHICS AND DISSEMINATION: This is a methodological survey that has been registered a priori on the International Prospective Register for Systematic Reviews (PROSPERO) (CRD42023475512). Local ethics approval is not required. We plan to disseminate study results through peer-reviewed publication and conference presentations.

The Conceptualization and Measurement of Research Impact in Primary Health Care: Protocol for a Rapid Scoping Review.

BACKGROUND: The generation of research evidence and knowledge in primary health care (PHC) is crucial for informing the development and implementation of interventions and innovations and driving health policy, health service improvements, and potential societal changes. PHC research has broad effects on patients, practices, services, population health, community, and policy formulation. The in-depth exploration of the definition and measures of research impact within PHC is essential for broadening our understanding of research impact in the discipline and how it compares to other health services research. OBJECTIVE: The objectives of the study are (1) to understand the conceptualizations and measures of research impact within the realm of PHC and (2) to identify methodological frameworks for evaluation and research impact and the benefits and challenges of using these approaches. The forthcoming review seeks to guide future research endeavors and enhance methodologies used in assessing research impact within PHC. METHODS: The protocol outlines the rapid review and environmental scan approach that will be used to explore research impact in PHC and will be guided by established frameworks such as the Canadian Academy of Health Sciences Impact Framework and the Canadian Health Services and Policy Research Alliance. The rapid review follows scoping review guidelines (PRISMA-ScR; Preferred Reporting Items for Systematic Review and Meta-Analysis Extension for Scoping Reviews). The environmental scan will be done by consulting with professional organizations, academic institutions, information science, and PHC experts. The search strategy will involve multiple databases, citation and forward citation searching, and manual searches of gray literature databases, think tank websites, and relevant catalogs. We will include gray and scientific literature focusing explicitly on research impact in PHC from high-income countries using the World Bank classification. Publications published in English from 1978 will be considered. The collected papers will undergo a 2-stage independent review process based on predetermined inclusion criteria. The research team will extract data from selected studies based on the research questions and the CRISP (Consensus Reporting Items for Studies in Primary Care) protocol statement. The team will discuss the extracted data, enabling the identification and categorization of key themes regarding research impact conceptualization and measurement in PHC. The narrative synthesis will evolve iteratively based on the identified literature. RESULTS: The results of this study are expected at the end of 2024. CONCLUSIONS: The forthcoming review will explore the conceptualization and measurement of research impact in PHC. The synthesis will offer crucial insights that will guide subsequent research, emphasizing the need for a standardized approach that incorporates diverse perspectives to comprehensively gauge the true impact of PHC research. Furthermore, trends and gaps in current methodologies will set the stage for future studies aimed at enhancing our understanding and measurement of research impact in PHC. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/55860.

Artificial intelligence and illusions of understanding in scientific research.

Scientists are enthusiastically imagining ways in which artificial intelligence (AI) tools might improve research. Why are AI tools so attractive and what are the risks of implementing them across the research pipeline? Here we develop a taxonomy of scientists' visions for AI, observing that their appeal comes from promises to improve productivity and objectivity by overcoming human shortcomings. But proposed AI solutions can also exploit our cognitive limitations, making us vulnerable to illusions of understanding in which we believe we understand more about the world than we actually do. Such illusions obscure the scientific community's ability to see the formation of scientific monocultures, in which some types of methods, questions and viewpoints come to dominate alternative approaches, making science less innovative and more vulnerable to errors. The proliferation of AI tools in science risks introducing a phase of scientific enquiry in which we produce more but understand less. By analysing the appeal of these tools, we provide a framework for advancing discussions of responsible knowledge production in the age of AI.

Practical Guidelines for Standardised Resolution of Important Protocol Deviations in Clinical Trials Conducted in Sub-Saharan Africa.

A clinical trial is any research on human subjects that involves an investigational medicinal product or device. Investigational medicinal products include unlicensed drugs or drugs used outside the product license (e.g. for a new indication) (ICH-GCP). As per the internationally accepted ICH-GCP guidelines, clinical trials should be conducted strictly per the approved protocol. However, during the lifecycle of a trial, protocol deviations may occur. Under ICH efficacy guidelines, protocol deviations are divided into non-important (minor) or important (major), and the latter can jeopardise the participant's rights, safety or the quality of data generated by the study. Existing guidelines on protocol deviation management do not detail or standardise actions to be taken for participants, investigational products, data or samples as part of a holistic management of important protocol deviations. Herein, we propose guidelines to address the current literature gap and promote the standardisation of actions to address important protocol deviations in clinical trials. The advised actions should complement the existing local institutional review board and national regulatory authority requirements.

Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement.

Importance: Transparent reporting of randomized trials is essential to facilitate critical appraisal and interpretation of results. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique methodological considerations. However, reporting of factorial trials is suboptimal. Objective: To develop a consensus-based extension to the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement for factorial trials. Design: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT extension for factorial trials was developed by (1) generating a list of reporting recommendations for factorial trials using a scoping review of methodological articles identified using a MEDLINE search (from inception to May 2019) and supplemented with relevant articles from the personal collections of the authors; (2) a 3-round Delphi survey between January and June 2022 to identify additional items and assess the importance of each item, completed by 104 panelists from 14 countries; and (3) a hybrid consensus meeting attended by 15 panelists to finalize the selection and wording of items for the checklist. Findings: This CONSORT extension for factorial trials modifies 16 of the 37 items in the CONSORT 2010 checklist and adds 1 new item. The rationale for the importance of each item is provided. Key recommendations are (1) the reason for using a factorial design should be reported, including whether an interaction is hypothesized, (2) the treatment groups that form the main comparisons should be clearly identified, and (3) for each main comparison, the estimated interaction effect and its precision should be reported. Conclusions and Relevance: This extension of the CONSORT 2010 Statement provides guidance on the reporting of factorial randomized trials and should facilitate greater understanding of and transparency in their reporting.

Moving Forward with Reporting Back Individual Environmental Health Research Results.

BACKGROUND: The practice of reporting back individual results to participants in environmental health research has evolved significantly over the past 20 years. Research findings support the potential of report-back to enhance the ethics, quality, and impact of environmental health research. Nonetheless, implementation of environmental health report-back practices is not yet routine. OBJECTIVES: We propose a framework for institutionalizing appropriate report-back to participants of their individual results across the environmental health research enterprise. We provide a brief overview of the rationales for report-back, social science research on report-back experiences over the past two decades, and recent efforts to synthesize guidance in this field. We also describe barriers to be addressed in moving toward widespread implementation of report-back. DISCUSSION: Report-back of individual results is increasingly recognized as an ethical responsibility and essential component of impactful environmental health research. Experience shows that when personal results are returned with appropriate contextual information, report-back can increase environmental health literacy, promote individual actions, and enhance engagement in policy change. Therefore, report-back can promote environmental justice and reduce disparities in access to science. Despite this evidence base, report-back is not widely implemented. We recommend the collaborative development of guidelines, training, and resources to build capacity for appropriate report-back to study participants across the environmental health research enterprise, and we identify research priorities to advance the field. Development of tools and shared infrastructure for report-back holds promise for reducing barriers while ensuring high-quality personalized reports. Disseminating successful case studies could also advance excellence. We recommend including diverse scientific disciplines, community partners, representatives of study populations, clinicians, institutional review boards (IRBs), legal experts, public health professionals, and government officials in further developing this critical aspect of environmental health research. https://doi.org/10.1289/EHP12463.

Is N-Hacking Ever OK? The consequences of collecting more data in pursuit of statistical significance.

Upon completion of an experiment, if a trend is observed that is "not quite significant," it can be tempting to collect more data in an effort to achieve statistical significance. Such sample augmentation or "N-hacking" is condemned because it can lead to an excess of false positives, which can reduce the reproducibility of results. However, the scenarios used to prove this rule tend to be unrealistic, assuming the addition of unlimited extra samples to achieve statistical significance, or doing so when results are not even close to significant; an unlikely situation for most experiments involving patient samples, cultured cells, or live animals. If we were to examine some more realistic scenarios, could there be any situations where N-hacking might be an acceptable practice? This Essay aims to address this question, using simulations to demonstrate how N-hacking causes false positives and to investigate whether this increase is still relevant when using parameters based on real-life experimental settings.

Scientific discovery in the age of artificial intelligence.

Artificial intelligence (AI) is being increasingly integrated into scientific discovery to augment and accelerate research, helping scientists to generate hypotheses, design experiments, collect and interpret large datasets, and gain insights that might not have been possible using traditional scientific methods alone. Here we examine breakthroughs over the past decade that include self-supervised learning, which allows models to be trained on vast amounts of unlabelled data, and geometric deep learning, which leverages knowledge about the structure of scientific data to enhance model accuracy and efficiency. Generative AI methods can create designs, such as small-molecule drugs and proteins, by analysing diverse data modalities, including images and sequences. We discuss how these methods can help scientists throughout the scientific process and the central issues that remain despite such advances. Both developers and users of AI toolsneed a better understanding of when such approaches need improvement, and challenges posed by poor data quality and stewardship remain. These issues cut across scientific disciplines and require developing foundational algorithmic approaches that can contribute to scientific understanding or acquire it autonomously, making them critical areas of focus for AI innovation.

Is the evidence-based medicine movement counter-productive: are randomised controlled trials the best approach to establish evidence in complex healthcare situations?

In the modern era, evidence-based medicine (EBM) has been embraced as the best approach to practising medicine, providing clinicians with 'objective' evidence from clinical research. However, for presentations with complex pathophysiology or from complex social environments, sometimes there remains no evidence, and no amount of research will obtain it. Yet, health researchers continue to undertake randomised controlled trials (RCT) in complex environments, ignoring the risk that participants' health may be compromised throughout the trial process. This paper examines the role of research that seeks to obtain evidence to support EBM. We provide examples of RCTs on ear disease in Aboriginal populations as a case-in-point. Decades of ear research have failed to yield statistically significant findings, demonstrating that when multiple factors are at play, study designs struggle to balance the known disease process drivers, let alone unknown drivers. This paper asks the reader to consider if the pursuit of research is likely to produce evidence in complex situations; or if perhaps RCTs should not be undertaken in these situations. Instead, clinicians could apply empirical evidence, tailoring treatments to individuals while taking into account the complexities of their life circumstances.

Principales dificultades de los proyectos de investigación de la especialidad Medicina General Integral / Main Difficulties of Research Projects of the General Comprehensive Medicine Specialty

Introducción: El residente de Medicina General Integral, una vez graduado, ejecutará investigaciones en correspondencia con las necesidades actuales del Sistema Nacional de Salud y a partir de los problemas de salud predominantes en su comunidad. Objetivo: Describir las principales dificultades en los proyectos de investigación de los residentes de la Especialidad de Medicina General Integral. Métodos: Se realizó un estudio observacional descriptivo transversal en la Facultad de Ciencias Médicas de Sagua la Grande en el período 2020-2021. La población objeto de análisis quedó constituida por un total de 69 proyectos de investigación provenientes de 5 policlínicos docentes de 3 municipios del territorio (Corralillo, Quemado de Güines y Sagua la Grande). Se revisó el proyecto de investigación, se confeccionó un modelo para la recogida de datos extraídos de los mismos y se elaboró una base de datos para su almacenamiento. Resultados: Las principales dificultades estuvieron dadas en no sustentar adecuadamente la investigación, en la redacción del problema científico, específicamente la relación entre el problema y el tipo de investigación, la conceptualización y/o operacionalización de las variables, la selección y elaboración de los métodos, técnicas e instrumentos para la recogida de la información y la acotación de la bibliografía por normas de Vancouver. Conclusiones: Resulta de vital importancia que los residentes de esta especialidad desarrollen habilidades investigativas desde el primer año de formación, lo que contribuirá a un mejor desempeño profesional a partir de la aplicación del método científico en la solución de los problemas de salud que se presenten en su quehacer diario(AU)

Introduction: The family medicine resident, once graduated, will do research in correspondence with the current needs of the national health system and considering the predominant health problems in her/his community. Objective: To describe the main difficulties in the research projects of residents in the General Comprehensive Medicine specialty. Methods: A cross-sectional, descriptive and observational study was carried out in the medical school of Sagua la Grande Municipality, in the period 2020-2021. The population under analysis consisted of a total of 69 research projects from five teaching polyclinics in three municipalities of the territory (Corralillo, Quemado de Güines and Sagua la Grande). Each research project was reviewed, a model was prepared for collecting the data extracted from them, and a database was elaborated for their storage. Results: The main difficulties were not supporting the research adequately, as well as in writing the scientific problem, specifically the relation between the problem and the type of research; also, the conceptualization or operationalization of variables, the selection and elaboration of methods, the techniques and instruments for the collection of information, and the bibliographical adjustment by the Vancouver norms. Conclusions: It is of vital importance that residents of this specialty develop research skills from the first year of training, which will contribute to better professional performance from the application of the scientific method in the solution of health problems that appear in their daily work(AU)

Minimum reporting standards for process and outcomes assessments for private practice dietitians working in Australian primary care: The Thought Leader Consensus study.

AIM: To identify minimum reporting standards for assessing the processes and outcomes of Australian primary care dietetics practice. METHODS: A sequential, mixed-method, exploratory process with peer-nominated Australian 'thought leaders'. A literature review was undertaken to identify possible standards, followed by semi-structured qualitative interviews with thought leaders. Content analysis was used to identify a comprehensive group of items that could inform evidence-based reporting standards. Two rounds of a modified Delphi survey were conducted with the same thought leaders to seek consensus on the most relevant items. Individual items were analysed for content validity, and those with a rating of excellent item-content validity (index >0.78) were included as evidenced-based standards for primary care practice. RESULTS: Twenty-six thought leaders (response rate: 87%) from all mainland Australian states completed a qualitative interview and two rounds of modified-Delphi consensus surveys. Items were identified and categorised into three domains: business, clinical, and implementation. Content analysis identified 216 items published or used in practice by the thought leaders. After two rounds of consensus review, 97 items (45 business, 33 clinical, and 19 implementation) achieved excellent consensus ratings. Combining these items into a standardised tool, the scale-content validity index average was >0.90, which is considered excellent content validity. CONCLUSIONS: This study has identified minimum reporting standards for evidence-based process and outcome assessments in primary care dietetics practice in Australia. Incorporating such standards into a standardised tool could enable benchmarking across the dietetics workforce and contribute to a broader understanding of the dietetic impact on public health.

Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension.

Importance: Clinicians, patients, and policy makers rely on published results from clinical trials to help make evidence-informed decisions. To critically evaluate and use trial results, readers require complete and transparent information regarding what was planned, done, and found. Specific and harmonized guidance as to what outcome-specific information should be reported in publications of clinical trials is needed to reduce deficient reporting practices that obscure issues with outcome selection, assessment, and analysis. Objective: To develop harmonized, evidence- and consensus-based standards for reporting outcomes in clinical trial reports through integration with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement. Evidence Review: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement was developed by (1) generation and evaluation of candidate outcome reporting items via consultation with experts and a scoping review of existing guidance for reporting trial outcomes (published within the 10 years prior to March 19, 2018) identified through expert solicitation, electronic database searches of MEDLINE and the Cochrane Methodology Register, gray literature searches, and reference list searches; (2) a 3-round international Delphi voting process (November 2018-February 2019) completed by 124 panelists from 22 countries to rate and identify additional items; and (3) an in-person consensus meeting (April 9-10, 2019) attended by 25 panelists to identify essential items for the reporting of outcomes in clinical trial reports. Findings: The scoping review and consultation with experts identified 128 recommendations relevant to reporting outcomes in trial reports, the majority (83%) of which were not included in the CONSORT 2010 statement. All recommendations were consolidated into 64 items for Delphi voting; after the Delphi survey process, 30 items met criteria for further evaluation at the consensus meeting and possible inclusion in the CONSORT-Outcomes 2022 extension. The discussions during and after the consensus meeting yielded 17 items that elaborate on the CONSORT 2010 statement checklist items and are related to completely defining and justifying the trial outcomes, including how and when they were assessed (CONSORT 2010 statement checklist item 6a), defining and justifying the target difference between treatment groups during sample size calculations (CONSORT 2010 statement checklist item 7a), describing the statistical methods used to compare groups for the primary and secondary outcomes (CONSORT 2010 statement checklist item 12a), and describing the prespecified analyses and any outcome analyses not prespecified (CONSORT 2010 statement checklist item 18). Conclusions and Relevance: This CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement provides 17 outcome-specific items that should be addressed in all published clinical trial reports and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results.

Guidelines for Reporting Outcomes in Trial Protocols: The SPIRIT-Outcomes 2022 Extension.

Importance: Complete information in a trial protocol regarding study outcomes is crucial for obtaining regulatory approvals, ensuring standardized trial conduct, reducing research waste, and providing transparency of methods to facilitate trial replication, critical appraisal, accurate reporting and interpretation of trial results, and knowledge synthesis. However, recommendations on what outcome-specific information should be included are diverse and inconsistent. To improve reporting practices promoting transparent and reproducible outcome selection, assessment, and analysis, a need for specific and harmonized guidance as to what outcome-specific information should be addressed in clinical trial protocols exists. Objective: To develop harmonized, evidence- and consensus-based standards for describing outcomes in clinical trial protocols through integration with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 statement. Evidence Review: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the SPIRIT-Outcomes 2022 extension of the SPIRIT 2013 statement was developed by (1) generation and evaluation of candidate outcome reporting items via consultation with experts and a scoping review of existing guidance for reporting trial outcomes (published within the 10 years prior to March 19, 2018) identified through expert solicitation, electronic database searches of MEDLINE and the Cochrane Methodology Register, gray literature searches, and reference list searches; (2) a 3-round international Delphi voting process (November 2018-February 2019) completed by 124 panelists from 22 countries to rate and identify additional items; and (3) an in-person consensus meeting (April 9-10, 2019) attended by 25 panelists to identify essential items for outcome-specific reporting to be addressed in clinical trial protocols. Findings: The scoping review and consultation with experts identified 108 recommendations relevant to outcome-specific reporting to be addressed in trial protocols, the majority (72%) of which were not included in the SPIRIT 2013 statement. All recommendations were consolidated into 56 items for Delphi voting; after the Delphi survey process, 19 items met criteria for further evaluation at the consensus meeting and possible inclusion in the SPIRIT-Outcomes 2022 extension. The discussions during and after the consensus meeting yielded 9 items that elaborate on the SPIRIT 2013 statement checklist items and are related to completely defining and justifying the choice of primary, secondary, and other outcomes (SPIRIT 2013 statement checklist item 12) prospectively in the trial protocol, defining and justifying the target difference between treatment groups for the primary outcome used in the sample size calculations (SPIRIT 2013 statement checklist item 14), describing the responsiveness of the study instruments used to assess the outcome and providing details on the outcome assessors (SPIRIT 2013 statement checklist item 18a), and describing any planned methods to account for multiplicity relating to the analyses or interpretation of the results (SPIRIT 2013 statement checklist item 20a). Conclusions and Relevance: This SPIRIT-Outcomes 2022 extension of the SPIRIT 2013 statement provides 9 outcome-specific items that should be addressed in all trial protocols and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results.