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Abstract Background This overview of reviews aims to identify evidence on the benefits (i.e. tobacco use abstinence and reduction in smoking frequency) and harms (i.e. possible adverse events/outcomes) of smoking cessation interventions among adults aged 18 years and older. Methods We searched Medline, Embase, PsycINFO, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, the CADTH Health Technology Assessment Database and several other websites for grey literature. Searches were conducted on November 12, 2018, updated on September 24, 2020, with publication years 2008 to 2020. Two reviewers independently performed title-abstract and full-text screening considering pre-determined inclusion criteria. Data extraction and quality assessments were initially completed by two reviewers independently (i.e. 73% of included studies (n = 22)) using A Measurement Tool to Assess Systematic Reviews-2 (AMSTAR 2), and the remainder done by one reviewer and verified by another due to resources and feasibility. The application of Grading of Recommendations Assessment, Development and Evaluation (GRADE) was performed by one independent reviewer and verified by another. Results A total of 22 Cochrane systematic reviews evaluating the impact of smoking cessation interventions on outcomes such as tobacco use abstinence, reduction in smoking frequency, quality of life and possible adverse events were included. Pharmaceutical (i.e. varenicline, cytisine, nicotine replacement therapy (NRT), bupropion) and behavioural interventions (i.e. physician advice, non-tailored print-based self-help materials, stage-based individual counselling, etc.) showed to have increased smoking cessation; whereas, data for mobile phone-based interventions including text messaging, hypnotherapy, acupuncture, continuous auricular stimulation, laser therapy, electrostimulation, acupressure, St John’s wort, S-adenosyl-L-methionine (SAMe), interactive voice response systems and other combination treatments were unclear. Considering harms related to smoking cessation interventions, small/mild harms (i.e. increased palpitations, chest pain, nausea, insomnia, headache) were observed following NRT, varenicline and cytisine use. There were no data on harms related to behavioural therapies (i.e. individual or group counselling self-help materials, internet interventions), combination therapies or other therapies (i.e. laser therapy, electrostimulation, acupressure, St John’s wort, SAMe). Conclusion Results suggest that pharmacological and behavioural interventions may help the general smoking population quit smoking with observed small/mild harms following NRT or varenicline. Consequently, evidence regarding ideal intervention strategies and the long-term impact of these interventions for preventing smoking was unclear. Systematic review registration PROSPERO CRD42018099691

Abstract Purpose Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024. Methods The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement. Results From the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review’s title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts. Conclusion PRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application. Note In order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

Abstract Background This systematic review aims to identify the benefits and harms of electronic cigarettes (e-cigarettes) as a smoking cessation aid in adults (aged ≥ 18 years) and to inform the development of the Canadian Task Force on Preventive Health Care’s (CTFPHC) clinical practice guidelines on e-cigarettes. Methods We searched Ovid MEDLINE®, Ovid MEDLINE® Epub Ahead of Print, In-Process & Other Non-Indexed Citations, PsycINFO, Embase Classic + Embase, and the Cochrane Library on Wiley. Searches were conducted from January 2016 to July 2019 and updated on 24 September 2020 and 25 January 2024. Two reviewers independently performed title-abstract and full-text screening according to the pre-determined inclusion criteria. Data extraction, quality assessments, and the application of Grading of Recommendations Assessment, Development and Evaluation (GRADE) were performed by one independent reviewer and verified by another. Results We identified 18 studies on 17 randomized controlled trials that compared e-cigarettes with nicotine to e-cigarettes without nicotine and e-cigarettes (with or without nicotine) to other interventions (i.e., no intervention, waitlist, standard/usual care, quit advice, or behavioral support). Considering the benefits of e-cigarettes in terms of smoking abstinence and smoking frequency reduction, 14 studies showed small or moderate benefits of e-cigarettes with or without nicotine compared to other interventions; although, with low, very low or moderate evidence certainty. With a focus on e-cigarettes with nicotine specifically, 12 studies showed benefits in terms of smoking abstinence when compared with usual care or non-nicotine e-cigarettes. In terms of harms following nicotine or non-nicotine e-cigarette use, 15 studies reported mild adverse events with little to no difference between groups and low to very low evidence certainty. Conclusion The evidence synthesis on the e-cigarette’s effectiveness shows data surrounding benefits having low to moderate evidence certainty for some comparisons and very low certainty for others, indicating that e-cigarettes may or probably increase smoking cessation, whereas, for harms, there is low to very low evidence certainty. Since the duration for outcome measurement varied among different studies, it may not be long-term enough for Adverse Events (AEs) to emerge, and there is a need for more research to understand the long-term benefits and potential harms of e-cigarettes. Systematic review registration PROSPERO CRD42018099692

Routinely collected health data (RCD) including electronic health records, disease registries, health administrative data and wearables data are not specifically collected for research purposes. Analysis of these data poses unique methodological challenges that must be addressed when conducting research, particularly as availability and use increase. This scoping review aimed to identify methodological challenges in research using RCD from existing literature (registered protocol: https://doi.org/10.17605/OSF.IO/EBM4D). We searched 6 electronic databases, including medical, health economics, nursing and psychology research databases, between Jan 2015 and Jan 2023, combining multiple “RCD” and “research” search terms (e.g., epidemiologic, informatics, pharmaceutical research). After screening abstracts and full-texts, we doubly extracted methodological themes, categorizing them into different study stages. We screened more than 23,000 records and included 430 papers. Bias and confounding were the most common methodological issues identified, discussed in relation to both study design and data analysis. Data quality, including data accuracy, validation, completeness, timeliness and cleaning, also posed substantial challenges, particularly during data processing stage. Record linkage and conducting analyses using distributed health networks also pose unique methodological challenges. Heterogeneity, incorporating social determinants of health and statistical models that address methodological challenges are also described in the literature. External validity and reporting are important considerations for RCD research. Our review identified several methodological challenges facing researchers using RCD. These issues should be addressed to ensure methodologically sound research. These findings will inform the development of a standardized protocol template and accompanying educational platform aimed at enhancing methodological quality and transparency when conducting research using RCD.

The field of traditional, complementary, and integrative medicine (TCIM) has garnered increasing attention due to its holistic approach to health and well-being. While the quantity of published research about TCIM has increased exponentially, critics have argued that the field faces challenges related to methodological rigour, reproducibility, and overall quality. This article proposes meta-research as one approach to evaluating and improving the quality of TCIM research. Meta-research, also known as research about research, can be defined as “the study of research itself: its methods, reporting, reproducibility, evaluation, and incentives”. By systematically evaluating methodological rigour, identifying biases, and promoting transparency, meta-research can enhance the reliability and credibility of TCIM research. Specific topics of interest that are discussed in this article include the following: 1) study design and research methodology, 2) reporting of research, 3) research ethics, integrity, and misconduct, 4) replicability and reproducibility, 5) peer review and journal editorial practices, 6) research funding: grants and awards, and 7) hiring, promotion, and tenure. For each topic, we provide case examples to illustrate meta-research applications in TCIM. We argue that meta-research initiatives can contribute to maintaining public trust, safeguarding research integrity, and advancing evidence based TCIM practice, while challenges include navigating methodological complexities, biases, and disparities in funding and academic recognition. Future directions involve tailored research methodologies, interdisciplinary collaboration, policy implications, and capacity building in meta-research.

Abstract The Consolidated Standards of Reporting Trials extension for Artificial Intelligence interventions (CONSORT-AI) was published in September 2020. Since its publication, several randomised controlled trials (RCTs) of AI interventions have been published but their completeness and transparency of reporting is unknown. This systematic review assesses the completeness of reporting of AI RCTs following publication of CONSORT-AI and provides a comprehensive summary of RCTs published in recent years. 65 RCTs were identified, mostly conducted in China (37%) and USA (18%). Median concordance with CONSORT-AI reporting was 90% (IQR 77–94%), although only 10 RCTs explicitly reported its use. Several items were consistently under-reported, including algorithm version, accessibility of the AI intervention or code, and references to a study protocol. Only 3 of 52 included journals explicitly endorsed or mandated CONSORT-AI. Despite a generally high concordance amongst recent AI RCTs, some AI-specific considerations remain systematically poorly reported. Further encouragement of CONSORT-AI adoption by journals and funders may enable more complete adoption of the full CONSORT-AI guidelines.

La declaración CONSORT 2010 proporciona unas directrices mínimas para informar sobre los ensayos clínicos aleatorizados. Su uso generalizado ha sido fundamental para garantizar la transparencia en la evaluación de nuevas intervenciones. Más recientemente, se ha reconocido cada vez más que las intervenciones con inteligencia artificial (IA) deben someterse a una evaluación rigurosa y prospectiva para demostrar su impacto en la salud. La extensión CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence) es una nueva pauta de información para los ensayos clínicos que evalúan intervenciones con un componente de IA, esta se desarrolló en paralelo con su declaración complementaria para los protocolos de ensayos clínicos: SPIRIT-AI (Standard Protocol Items – Artificial Intelligence: Recomendaciones para ensayos clínicos de intervención - Inteligencia Artificial). Ambas directrices se desarrollaron a través de un proceso de consenso por etapas que incluía la revisión de la literatura y la consulta a expertos para generar 29 elementos candidatos, que fueron evaluados por un grupo internacional de múltiples partes interesadas en una encuesta Delphi de dos etapas (103 partes interesadas congregados en una reunión de consenso de dos días (31 partes interesadas) y refinados a través de una lista de verificación piloto (34 participantes). La ampliación del CONSORT-AI incluye 14 nuevos elementos que se consideraron lo suficientemente importantes para las intervenciones de IA como para que se informen de forma rutinaria, además de los elementos básicos del CONSORT 2010. CONSORT-AI recomienda que los investigadores proporcionen descripciones claras de la intervención de IA, incluyendo las instrucciones y las habilidades requeridas para su uso, el entorno en el que se integra la intervención de IA, el manejo de los datos de entrada y los datos de salida de la intervención de IA, la interacción entre el ser humano y la IA y la provisión de un análisis de los casos de error. CONSORT-AI ayudará a promover la transparencia y la exhaustividad en los informes de los ensayos clínicos de las intervenciones de AI, también ayudará a los editores y revisores, así como a los lectores en general, a entender, interpretar y valorar críticamente la calidad del diseño del ensayo clínico y el riesgo de sesgo en los resultados comunicados.

Abstract Purpose To inform updated recommendations by the Canadian Task Force on Preventive Health Care on screening in a primary care setting for hypertension in adults aged 18 years and older. This protocol outlines the scope and methods for a series of systematic reviews and one overview of reviews. Methods To evaluate the benefits and harms of screening for hypertension, the Task Force will rely on the relevant key questions from the 2021 United States Preventive Services Task Force systematic review. In addition, a series of reviews will be conducted to identify, appraise, and synthesize the evidence on (1) the association of blood pressure measurement methods and future cardiovascular (CVD)-related outcomes, (2) thresholds for discussions of treatment initiation, and (3) patient acceptability of hypertension screening methods. For the review of blood pressure measurement methods and future CVD-related outcomes, we will perform a de novo review and search MEDLINE, Embase, CENTRAL, and APA PsycInfo for randomized controlled trials, prospective or retrospective cohort studies, nested case–control studies, and within-arm analyses of intervention studies. For the thresholds for discussions of treatment initiation review, we will perform an overview of reviews and update results from a relevant 2019 UK NICE review. We will search MEDLINE, Embase, APA PsycInfo, and Epistemonikos for systematic reviews. For the acceptability review, we will perform a de novo systematic review and search MEDLINE, Embase, and APA PsycInfo for randomized controlled trials, controlled clinical trials, and observational studies with comparison groups. Websites of relevant organizations, gray literature sources, and the reference lists of included studies and reviews will be hand-searched. Title and abstract screening will be completed by two independent reviewers. Full-text screening, data extraction, risk-of-bias assessment, and GRADE (Grading of Recommendations Assessment, Development and Evaluation) will be completed independently by two reviewers. Results from included studies will be synthesized narratively and pooled via meta-analysis when appropriate. The GRADE approach will be used to assess the certainty of evidence for outcomes. Discussion The results of the evidence reviews will be used to inform Canadian recommendations on screening for hypertension in adults aged 18 years and older. Systematic review registration This protocol is registered on PROSPERO and is available on the Open Science Framework (osf.io/8w4tz).

Abstract Background The transition from childhood to adolescence is associated with an increase in rates of some psychiatric disorders, including major depressive disorder, a debilitating mood disorder. The aim of this systematic review is to update the evidence on the benefits and harms of screening for depression in primary care and non-mental health clinic settings among children and adolescents. Methods This review is an update of a previous systematic review, for which the last search was conducted in 2017. We searched Ovid MEDLINE® ALL, Embase Classic+Embase, PsycINFO, Cochrane Central Register of Controlled Trials, and CINAHL on November 4, 2019, and updated on February 19, 2021. If no randomized controlled trials were found, we planned to conduct an additional search for non-randomized trials with a comparator group. For non-randomized trials, we applied a non-randomized controlled trial filter and searched the same databases except for Cochrane Central Register of Controlled Trials from January 2015 to February 2021. We also conducted a targeted search of the gray literature for unpublished documents. Title and abstract, and full-text screening were completed independently by pairs of reviewers. Results In this review update, we were unable to find any randomized controlled studies that satisfied our eligibility criteria and evaluated the potential benefits and harms of screening for depression in children and adolescents. Additionally, a search for non-randomized trials yielded no studies that met the inclusion criteria. Conclusions The findings of this review indicate a lack of available evidence regarding the potential benefits and harms of screening for depression in children and adolescents. This absence of evidence emphasizes the necessity for well-conducted clinical trials to evaluate the effectiveness of depression screening among children and adolescents in primary care and non-mental health clinic settings. Systematic review registration PROSPERO CRD42020150373 .

Abstract Background Despite the critical importance of clinical trials to provide evidence about the effects of intervention for children and youth, a paucity of published high-quality pediatric clinical trials persists. Sub-optimal reporting of key trial elements necessary to critically appraise and synthesize findings is prevalent. To harmonize and provide guidance for reporting in pediatric controlled clinical trial protocols and reports, reporting guideline extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) guidelines specific to pediatrics are being developed: SPIRIT-Children (SPIRIT-C) and CONSORT-Children (CONSORT-C). Methods The development of SPIRIT-C/CONSORT-C will be informed by the Enhancing the Quality and Transparency of Health Research Quality (EQUATOR) method for reporting guideline development in the following stages: (1) generation of a preliminary list of candidate items, informed by (a) items developed during initial development efforts and child relevant items from recent published SPIRIT and CONSORT extensions; (b) two systematic reviews and environmental scan of the literature; (c) workshops with young people; (2) an international Delphi study, where a wide range of panelists will vote on the inclusion or exclusion of candidate items on a nine-point Likert scale; (3) a consensus meeting to discuss items that have not reached consensus in the Delphi study and to “lock” the checklist items; (4) pilot testing of items and definitions to ensure that they are understandable, useful, and applicable; and (5) a final project meeting to discuss each item in the context of pilot test results. Key partners, including young people (ages 12–24 years) and family caregivers (e.g., parents) with lived experiences with pediatric clinical trials, and individuals with expertise and involvement in pediatric trials will be involved throughout the project. SPIRIT-C/CONSORT-C will be disseminated through publications, academic conferences, and endorsement by pediatric journals and relevant research networks and organizations. Discussion SPIRIT/CONSORT-C may serve as resources to facilitate comprehensive reporting needed to understand pediatric clinical trial protocols and reports, which may improve transparency within pediatric clinical trials and reduce research waste. Trial Registration The development of these reporting guidelines is registered with the EQUATOR Network: SPIRIT-Children ( https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials-protocols/#35 ) and CONSORT-Children ( https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#CHILD ).

Background: The literature on gun violence is broad and variable, describing multiple legislation types and outcomes in observational studies. Our objective was to document the extent and nature of evidence on the impact of firearm legislation on mortality from firearm violence. Methods: A scoping review was conducted under PRISMA-ScR guidance. A comprehensive peer-reviewed search strategy was executed in several electronic databases from inception to March 2024. Grey literature was searched for unpublished sources. Data were extracted on study design, country, population, type of legislation, and overall study conclusions on legislation impact on mortality from suicide, homicide, femicide, and domestic violence. Critical appraisal for a sample of articles with the same study design (ecological studies) was conducted for quality assessment. Findings: 5057 titles and abstracts and 651 full-text articles were reviewed. Following full-text review and grey literature search, 202 articles satisfied our eligibility criteria. Federal legislation was identified from all included countries, while state-specific laws were only reported in studies from the U.S. Numerous legislative approaches were identified including preventative, prohibitive, and more tailored strategies focused on identifying high risk individuals. Law types had various effects on rates of firearm homicide, suicide, and femicide. Lack of robust design, uneven implementation, and poor evaluation of legislation may contribute to these differences. Interpretation: We found that national, restrictive laws reduce population-level firearm mortality. These findings can inform policy makers, public health researchers, and governments when designing and implementing legislation to reduce injury and death from firearms. Funding: Funding is provided by the Strategy for Patient-Oriented Research (SPOR) Evidence Alliance and in part by St. Michael’s Hospital, University of Toronto. Scoping review registration:: Open Science Framework (OSF): https://osf.io/sf38n.

This educational article explores the convergence of open science practices and traditional, complementary, and integrative medicine (TCIM), shedding light on the potential benefits and challenges of open science for the development, dissemination, and implementation of evidence-based TCIM. We emphasize the transformative shift in medical science towards open and collaborative practices, highlighting the limited application of open science in TCIM research despite its growing acceptance among patients. We define open science practices and discuss those that are applicable to TCIM, including: study registration; reporting guidelines; data, code and material sharing; preprinting; publishing open access; and reproducibility/replication studies. We explore the benefits of open science in TCIM, spanning improved research quality, increased public trust, accelerated innovation, and enhanced evidence-based decision-making. We also acknowledge challenges such as data privacy concerns, limited resources, and resistance to cultural change. We propose strategies to overcome these challenges, including ethical guidelines, education programs, funding advocacy, interdisciplinary dialogue, and patient engagement. Looking to the future, we envision the maturation of open science in TCIM, the development of TCIM-specific guidelines for open science practices, advancements in data sharing platforms, the integration of open data and artificial intelligence in TCIM research, and changes in the context of policy and regulation. We foresee a future where open science in TCIM leads to a better evidence base, informed decision-making, interdisciplinary collaboration, and transformative impacts on healthcare and research methodologies, highlighting the promising synergy between open science and TCIM for holistic, evidence-based healthcare solutions.

Introduction Large language model (LLM)-linked chatbots are being increasingly applied in healthcare due to their impressive functionality and public availability. Studies have assessed the ability of LLM-linked chatbots to provide accurate clinical advice. However, the methods applied in these Chatbot Assessment Studies are inconsistent due to the lack of reporting standards available, which obscures the interpretation of their study findings. This protocol outlines the development of the Chatbot Assessment Reporting Tool (CHART) reporting guideline.Methods and analysis The development of the CHART reporting guideline will consist of three phases, led by the Steering Committee. During phase one, the team will identify relevant reporting guidelines with artificial intelligence extensions that are published or in development by searching preprint servers, protocol databases, and the Enhancing the Quality and Transparency of health research Network. During phase two, we will conduct a scoping review to identify studies that have addressed the performance of LLM-linked chatbots in summarising evidence and providing clinical advice. The Steering Committee will identify methodology used in previous Chatbot Assessment Studies. Finally, the study team will use checklist items from prior reporting guidelines and findings from the scoping review to develop a draft reporting checklist. We will then perform a Delphi consensus and host two synchronous consensus meetings with an international, multidisciplinary group of stakeholders to refine reporting checklist items and develop a flow diagram.Ethics and dissemination We will publish the final CHART reporting guideline in peer-reviewed journals and will present findings at peer-reviewed meetings. Ethical approval was submitted to the Hamilton Integrated Research Ethics Board and deemed “not required” in accordance with the Tri-Council Policy Statement (TCPS2) for the development of the CHART reporting guideline (#17025).Registration This study protocol is preregistered with Open Science Framework: https://doi.org/10.17605/OSF.IO/59E2Q.

Abstract Background Incomplete reporting about what systematic reviewers did and what they found prevents users of the report from being able to fully interpret the findings and understand the limitations of the underlying evidence. Reporting guidelines such as the PRISMA statement and its extensions are designed to improve reporting. However, there are important inconsistencies across the various PRISMA reporting guidelines, which causes confusion and misinterpretation. Coupled with this, users might need to consult multiple guidelines to gain a full understanding of the guidance. Furthermore, the current passive strategy of implementing PRISMA has not fully brought about needed improvements in the completeness of systematic review reporting. Methods The PRISMATIC (‘PRISMA, Technology, and Implementation to enhance reporting Completeness’) project aims to use novel methods to enable more efficient and effective translation of PRISMA reporting guidelines into practice. We will establish a working group who will develop a unified PRISMA statement that harmonises content across the main PRISMA guideline and several of its extensions. We will then develop a web application that generates a reporting template and checklist customised to the characteristics and methods of a systematic review (‘PRISMA-Web app’) and conduct a randomised trial to evaluate its impact on authors’ reporting. We will also develop a web application that helps peer reviewers appraise systematic review manuscripts (‘PRISMA-Peer app’) and conduct a diagnostic accuracy study to evaluate its impact on peer reviewers’ detection of incomplete reporting. Discussion We anticipate the novel guidance and web-based apps developed throughout the project will substantively enhance the completeness of reporting of systematic reviews of health evidence, ultimately benefiting users who rely on systematic reviews to inform health care decision-making.

The convergence of traditional, complementary, and integrative medicine (TCIM) with artificial intelligence (AI) is a promising frontier in healthcare. TCIM is a patient-centric approach that combines conventional medicine with complementary therapies, emphasizing holistic well-being. AI can revolutionize healthcare through data-driven decision-making and personalized treatment plans. This article explores how AI technologies can complement and enhance TCIM, aligning with the shared objectives of researchers from both fields in improving patient outcomes, enhancing care quality, and promoting holistic wellness. This integration of TCIM and AI introduces exciting opportunities but also noteworthy challenges. AI may augment TCIM by assisting in early disease detection, providing personalized treatment plans, predicting health trends, and enhancing patient engagement. Challenges at the intersection of AI and TCIM include data privacy and security, regulatory complexities, maintaining the human touch in patient-provider relationships, and mitigating bias in AI algorithms. Patients' trust, informed consent, and legal accountability are all essential considerations. Future directions in AI-enhanced TCIM include advanced personalized medicine, understanding the efficacy of herbal remedies, and studying patient-provider interactions. Research on bias mitigation, patient acceptance, and trust in AI-driven TCIM healthcare is crucial. In this article, we outlined that the merging of TCIM and AI holds great promise in enhancing healthcare delivery, personalizing treatment plans, preventive care, and patient engagement. Addressing challenges and fostering collaboration between AI experts, TCIM practitioners, and policymakers, however, is vital to harnessing the full potential of this integration.

Objective Open science is a movement and set of practices to conduct research more transparently. Implementing open science will significantly improve public access and supports equity. It also has the potential to foster innovation and reduce duplication through data and materials sharing. Here, we survey an international group of researchers publishing in cardiovascular journals regarding their perceptions and practices related to open science.Methods We identified the top 100 ‘Cardiology and Cardiovascular Medicine’ subject category journals from the SCImago journal ranking platform. This is a publicly available portal that draws from Scopus. We then extracted the corresponding author’s name and email from all articles published in these journals between 1 March 2021 and 1 March 2022. Participants were sent a purpose-built survey about open science. The survey contained primarily multiple choice and scale-based questions for which we report count data and percentages. For the few text-based responses we conducted thematic content analysis.Results 198 participants responded to our survey. Participants had a mean response of 6.8 (N=197, SD=1.8) on a 9-point scale with endpoints, not at all familiar (1) and extremely familiar (9), when indicating how familiar they were with open science. When asked about where they obtained open science training, most participants indicated this was done on the job self-initiated while conducting research (n=103, 52%), or that they had no formal training with respect to open science (n=72, 36%). More than half of the participants indicated they would benefit from practical support from their institution on how to perform open science practices (N=106, 54%). A diversity of barriers to each of the open science practices presented to participants were acknowledged. Participants indicated that funding was the most essential incentive to adopt open science.Conclusions It is clear that policy alone will not lead to the effective implementation of open science. This survey serves as a baseline for the cardiovascular research community’s open science performance and perception and can be used to inform future interventions and monitoring.

BackgroundOpen science practices are implemented across many scientific fields to improve transparency and reproducibility in research. Complementary, alternative, and integrative medicine (CAIM) is a growing field that may benefit from adoption of open science practices. The efficacy and safety of CAIM practices, a popular concern with the field, can be validated or refuted through transparent and reliable research. Investigating open science practices across CAIM journals by using the Transparency and Openness Promotion (TOP) guidelines can potentially promote open science practices across CAIM journals. The purpose of this study is to conduct an audit that compares and ranks open science practices adopted by CAIM journals against TOP guidelines laid out by the Center for Open Science (COS).MethodsCAIM-specific journals with titles containing the words "complementary", "alternative" and/or "integrative" were included in this audit. Each of the eight TOP criteria were used to extract open science practices from each of the CAIM journals. Data was summarized by the TOP guideline and ranked using the TOP Factor to identify commonalities and differences in practices across the included journals.ResultsA total of 19 CAIM journals were included in this audit. Across all journals, the mean TOP Factor was 2.95 with a median score of 2. The findings of this study reveal high variability among the open science practices required by journals in this field. Four journals (21%) had a final TOP score of 0, while the total scores of the remaining 15 (79%) ranged from 1 to 8.ConclusionWhile several studies have audited open science practices across discipline-specific journals, none have focused on CAIM journals. The results of this study indicate that CAIM journals provide minimal guidelines to encourage or require authors to adhere to open science practices and there is an opportunity to improve the use of open science practices in the field.

ObjectiveTo assess the reporting quality of published RCT abstracts regarding patients with endometriosis pelvic pain and investigate the prevalence and characteristics of spin in these abstracts.MethodsPubMed and Scopus were searched for RCT abstracts addressing endometriosis pelvic pain published from January 1st, 2010 to December 1st, 2023.The reporting quality of RCT abstracts was assessed using the CONSORT statement for abstracts. Additionally, spin was evaluated in the results and conclusions section of the abstracts, defined as the misleading reporting of study findings to emphasize the perceived benefits of an intervention or to confound readers from statistically non-significant results. Assessing factors affecting the reporting quality and spin existence, linear and logistic regression was used, respectively.ResultsA total of 47 RCT abstracts were included. Out of 16 checklist items, only three items including objective, intervention and conclusions were sufficiently reported in the most abstracts (more than 95%), and none of the abstracts presented precise data as required by the CONSORT-A guidelines. In the reporting quality of material and method section, trial design, type of randomization, the generation of random allocation sequences, the allocation concealment and blinding were most items identified that were suboptimal. The total score for the quality varied between 5 and 15 (mean: 9.59, SD: 3.03, median: 9, IQR: 5). Word count (beta = 0.015, p-value = 0.005) and publishing in open-accessed journals (beta = 2.023, p-value = 0.023) were the significant factors that affecting the reporting quality. Evaluating spin within each included paper, we found that 18 (51.43%) papers had statistically non-significant results. From these studies, 12 (66.66%) had spin in both results and conclusion sections. Furthermore, the spin intensity increased during 2010-2023 and 38.29% of abstracts had spin in both results and conclusion sections.ConclusionOverall poor adherence to CONSORT-A was observed, with spin detected in several RCTs featuring non-significant primary endpoints in obstetrics and gynecology literature.

Introduction and objectiveOpen science (OS) aims to make the dissemination of knowledge and the research process transparent and accessible to everyone. With the increasing popularity of complementary, alternative, and integrative medicine (CAIM), our goal was to explore what are CAIM researchers' practices and perceived barriers related to OS.MethodsWe conducted an anonymous online survey of researchers who published in journals listed in Scopus containing the words "complementary", "alternative", or "integrative" medicine in their names. We emailed 6040 researchers our purpose-built electronic survey after extracting their email address from one of their publications in our sample of journals. We questioned their familiarity with different OS concepts, along with their experiences and challenges engaging in these practices over the last 12 months.ResultsThe survey was completed by 392 researchers (6.5% response rate, 97.1% completion rate). Most respondents were CAIM researchers familiar with the overall concept of OS, indicated by those actively publishing open access (OA) (n = 244, 76.0%), registering a study protocol (n = 148, 48.0%), and using reporting guidelines (n = 181, 59.0%) in the past 12 months. Preprinting, sharing raw data, and sharing study materials were less popular. A lack of funding was reported as the greatest barrier to publishing OA by most respondents (n = 252, 79.0%), and that additional funding is the most significant incentive in applying more OS practices to their research (n = 229,72.2%). With respect to preprinting barriers, 36.3% (n = 110) participants believed there are potential harms in sharing non-peer-reviewed work and 37.0% (n = 112) feared preprinting would reduce the likelihood of their manuscript being accepted by a journal. Respondents were also concerned about intellectual property control regarding sharing data (n = 94, 31.7%) and research study materials (n = 80, 28.7%).ConclusionsAlthough many participants were familiar with and practiced aspects of OS, many reported facing barriers relating to lack of funding to enable OS and perceived risks of revealing research ideas and data prior to publication. Future research should monitor the adoption and implementation of OS interventions in CAIM.

The definition of complementary, alternative, and integrative medicine (CAIM) remains dynamic and complex despite a steady increase in the popularity/usage of CAIM therapies across the globe. A lack of consistency in how these terms are defined remains a challenge for researchers, clinicians, and national and international organizations (e.g., World Health Organization, National Center for Complementary and Integrative Health) alike. In the present article, we provide a brief history of the use of these terminologies, and then outline the process we took to develop and create an operational definition of complementary, alternative, and integrative medicine. Our operational definition is the first to be informed by a systematic search of four quality-assessed information resource types, ultimately yielding 604 unique CAIM therapies. We then developed a single search string for the most common bibliographic databases using the finalized operational definition list of CAIM therapies. These CAIM therapies were searched against the Therapeutic Research Center's “Natural Medicines” database for all 604 therapies, whereby each item's scientific name and/or synonym was included as a keyword or phrase in the search string. While the current definition is not without limitations and ongoing debates still surround the field, this work is arguably a steppingstone towards enabling increased collaboration and communication amongst healthcare clinicians, researchers, and the public. This operational definition provides a foundation for developing well-coordinated research efforts that will assist in the acceptance and understanding of this field, while also focusing on adopting knowledge translation techniques and efforts for further research advancement and use.

INTRODUCTION: The debate on scientific research and reporting integrity issues in Brazil is incipient. Literature suggests that a journalology training course could help to improve the competencies of the participants. OBJECTIVE: To evaluate the immediate impact of a journalology training course on perceived academic competencies, comprised of knowledge, attitudes, and skills. METHODS: The course was taught in 5 consecutive days to an online audience of individuals from the health sciences. A self-applied questionnaire was employed before and immediately after the course, which included initial and acquired perceived knowledge, attitudes, skills. The Wilcoxon non-parametric test for paired samples was used for analysis. RESULTS: A total of 45 individuals participated in the course, with a 53% response rate before and after. The number of participants in each course session ranged between 32 and 45. There was an improvement in perceived knowledge of: (1) writing review articles; (2) ethical aspects of research; (3) scientific authorship; (4) predatory practices; (5) publication bias and spin, and (6) researcher evaluation. There was no improvement in self-reported attitudes towards any item. There was an improvement in the perception of skills relating to: (1) writing a response letter and (2) writing an opinion as a reviewer. CONCLUSIONS: Overall, attendees who participated in the survey reported perceived improved knowledge and skills in some items but not in their attitudes. Therefore, the course appears to have been unable to modify perceived scientific reporting competencies.

Background: There is a growing body of literature on complementary, alternative, and integrative medicine (CAIM), which offers a holistic approach to health and the maintenance of social and cultural values. Bibliometric analyses are an increasingly commonly used method employing quantitative statistical techniques to understand trends in a particular scientific field. The objective of this scoping review is to investigate the quantity and characteristics of evidence in relation to bibliometric analyses of CAIM literature. Methods: The following bibliographic databases will be searched: MEDLINE, EMBASE, PsycINFO, AMED, CINAHL, Scopus and Web of Science. Studies published in English, conducting any type of bibliometric analysis involving any CAIM therapies, as detailed by an operational definition of CAIM adopted by Cochrane Complementary Medicine, will be included. Conference abstracts and study protocols will be excluded. The following variables will be extracted from included studies: title, author, year, country, study objective, type of CAIM, health condition targeted, databases searched in the bibliometric analysis, the type of bibliometric variables assessed, how bibliometric information was reported, main findings, conclusions, and limitations. Findings will be summarized narratively, as well as in tabular and graphical format. Conclusions: To the best of our knowledge, this scoping review will be the first to investigate the characteristics of evidence in relation to bibliometric analyses on CAIM literature. The findings of this review may be useful to identify variations in the objectives, methods, and results of bibliometric analyses of CAIM research literature.

Abstract Background The global spread of COVID-19 created an explosion in rapid tests with results in

Adherence to study registration and reporting best practices is vital to fostering evidence-based medicine. All registered clinical trials on ClinicalTrials.gov conducted in Canada as of 2009 and completed by 2019 were identified. A cross-sectional analysis of those trials assessed prospective registration, subsequent result reporting in the registry, and subsequent publication of study findings. The lead sponsor, phase of study, clinical trial site location, total patient enrollment, number of arms, type of masking, type of allocation, year of completion, and patient demographics were examined as potential effect modifiers to these best practices. A total of 6720 trials were identified. From 2009 to 2019, 59% (n = 3,967) of them were registered prospectively, and 32% (n = 2138) had neither their results reported nor their findings published. Of the 3763 trials conducted exclusively in Canada, 3% (n = 123) met all three criteria of prospective registration, reporting in the registry, and publishing findings. Overall, the odds of having adherence to all three practices concurrently in Canadian trials decrease by 95% when compared with international trials. Canadian clinical trials substantially lacked adherence to study registration and reporting best practices. Knowledge of this widespread non-compliance should motivate stakeholders in the Canadian clinical trial ecosystem to address and continue to monitor this problem.

The Canadian Institutes of Health Research (CIHR) commenced a Quality Assurance Program in 2019 to monitor the quality of peer review in its Project Grant Competition Peer Review Committees. Our primary aim was to describe the performance of CIHR grant peer reviewers, based on the assessments made by CIHR peer review leaders during the first 3 years of the Research Quality Assurance Program. All Peer Review Committee Chairs and (or) Scientific Officers who led peer review for CIHR in 2019, 2020, and 2021 completed Reviewer Quality Feedback forms immediately following Peer Review Committee meetings. The form assessed Performance, Future potential, Review quality, Participation, and Responsiveness. We summarised and descriptively synthesised data from assessments conducted after each of the four grant competitions. The performance of peer reviewers on 4438 occasions was rated by Chairs and Scientific Officers. Approximately one in three peer reviewers submitted outstanding reviews or discussed additional applications and one in 10 demonstrated potential as a future Peer Review Committee leader. At most, one in 20 peer reviewers was considered to have not performed adequately with respect to review quality, participation, or responsiveness. There is a need for more research on the processes involved in allocating research grant funding.

Abstract Background Reporting quality is a critical issue in health sciences. Adopting the reporting guidelines has been approved to be an effective way of enhancing the reporting quality and transparency of clinical research. In 2012, we found that only 7 (7/1221, 0.6%) journals adopted the Consolidated Standards of Reporting Trials (CONSORT) statement in China. The aim of the study was to know the implementation status of CONSORT and other reporting guidelines about clinical studies in China. Methods A cross-sectional bibliometric study was conducted. Eight medical databases were systematically searched, and 1039 medical journals published in mainland China, Hong Kong, Macau, and Taiwan were included. The basic characteristics, including subject, language, publication place, journal-indexed databases, and journal impact factors were extracted. The endorsement of reporting guidelines was assessed by a modified 5-level evaluation tool, namely i) positive active, ii) positive weak, iii) passive moderate, iv) passive weak and v) none. Results Among included journals, 24.1% endorsed CONSORT, and 0.8% endorsed CONSORT extensions. For STROBE (STrengthening the Reporting of Observational Studies in Epidemiology), PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses), STARD (An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies), CARE (CAse REport guidelines), the endorsement proportion were 17.2, 16.6, 16.4, and 14.8% respectively. The endorsement proportion for SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials), TRIPOD (Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis), AGREE (Appraisal of Guidelines, Research, and Evaluation), and RIGHT (Reporting Items for Practice Guidelines in Healthcare) were below 0.7%. Conclusions Our results showed that the implementation of reporting guidelines was low. We suggest the following initiatives including i) enhancing the level of journal endorsement for reporting guidelines; ii) strengthening the collaboration among authors, reviewers, editors, and other stakeholders; iii) providing training courses for stakeholders; iv) establishing bases for reporting guidelines network in China; v) adopting the endorsement of reporting guidelines in the policies of the China Periodicals Association (CPA); vi) promoting Chinese medical journals into the international evaluation system and publish in English.

BackgroundMulticenter clinical trials play an indispensable role for assessing the efficacy of a new intervention or treatment, particularly in Phase II or III studies. Previous studies have shown that these studies often suffer from inadequate reporting of key details related to their design, implementation, and analysis, both in the protocol and final reports. This limitation reduces the practical and scientific value of the findings. Furthermore, the lack of guidance on how to report multicenter features can contribute to poor reporting. Therefore, this study aims to develop guidelines to improve the reporting of multicenter trials, including two Extensions of the CONSORT 2010 and the SPIRIT 2013.Methods/designThe standard methodology for developing health research reporting guidelines involves the following steps: (i) Identifying the need for development and launching the research project; (ii) Preparing the registration and reviewing the literatures; (iii) Proposing the initial Checklists and conducting the Delphi exercise; (iv) Arranging the consensus meeting and formulating the Checklists; (v) Conducting the pilot test and drafting explanatory documents (E&E); (vi) Seeking comments from advisory group and finalizing the guidelines; and (vii) Developing the publication and dissemination strategies.ConclusionBy using the CONSORT and SPIRIT checklists as starting points, the development of extensions specific to multicenter trials can help researchers design and report high-quality clinical research. This, in turn, can facilitate the application of study findings in the current evidence-based healthcare system.

Objective We conducted a systematic review to evaluate associations between influenza vaccination during pregnancy and adverse birth outcomes and maternal non-obstetric serious adverse events (SAEs), taking into consideration confounding and temporal biases.Methods Electronic databases (Ovid MEDLINE ALL, Embase Classic+Embase and the Cochrane Central Register of Controlled Trials) were searched to June 2021 for observational studies assessing associations between influenza vaccination during pregnancy and maternal non-obstetric SAEs and adverse birth outcomes, including preterm birth, spontaneous abortion, stillbirth, small-for-gestational-age birth and congenital anomalies. Studies of live attenuated vaccines, single-arm cohort studies and abstract-only publications were excluded. Records were screened using a liberal accelerated approach initially, followed by a dual independent approach for full-text screening, data extraction and risk of bias assessment. Pairwise meta-analyses were conducted, where two or more studies met methodological criteria for inclusion. The Grading of Recommendations, Assessment, Development and Evaluation approach was used to assess evidence certainty.Results Of 9443 records screened, 63 studies were included. Twenty-nine studies (24 cohort and 5 case–control) evaluated seasonal influenza vaccination (trivalent and/or quadrivalent) versus no vaccination and were the focus of our prioritised syntheses; 34 studies of pandemic vaccines (2009 A/H1N1 and others), combinations of pandemic and seasonal vaccines, and seasonal versus seasonal vaccines were also reviewed. Control for confounding and temporal biases was inconsistent across studies, limiting pooling of data. Meta-analyses for preterm birth, spontaneous abortion and small-for-gestational-age birth demonstrated no significant associations with seasonal influenza vaccination. Immortal time bias was observed in a sensitivity analysis of meta-analysing risk-based preterm birth data. In descriptive summaries for stillbirth, congenital anomalies and maternal non-obstetric SAEs, no significant association with increased risk was found in any studies. All evidence was of very low certainty.Conclusions Evidence of very low certainty suggests that seasonal influenza vaccination during pregnancy is not associated with adverse birth outcomes or maternal non-obstetric SAEs. Appropriate control of confounding and temporal biases in future studies would improve the evidence base.

Background: The sharing of health-related information has become increasingly popular on social media. Unregulated information sharing has led to the spread of misinformation, especially regarding complementary, alternative, and integrative medicine (CAIM). This scoping review synthesized evidence surrounding the spread of CAIM-related misinformation on social media during the COVID-19 pandemic. Methods: This review was informed by a modified version of the Arksey and O'Malley scoping review framework. AMED, EMBASE, PsycINFO and MEDLINE databases were searched systematically from inception to January 2022. Eligible articles explored COVID-19 misinformation on social media and contained sufficient information on CAIM therapies. Common themes were identified using an inductive thematic analysis approach. Results: Twenty-eight articles were included. The following themes were synthesized: 1) misinformation prompts unsafe and harmful behaviours, 2) misinformation can be separated into different categories, 3) individuals are capable of identifying and refuting CAIM misinformation, and 4) studies argue governments and social media companies have a responsibility to resolve the spread of COVID-19 misinformation. Conclusions: Misinformation can spread more easily when shared on social media. Our review suggests that misinformation about COVID-19 related to CAIM that is disseminated online contributes to unsafe health behaviours, however, this may be remedied via public education initiatives and stricter media guidelines. The results of this scoping review are crucial to understanding the behavioural impacts of the spread of COVID-19 misinformation about CAIM therapies, and can inform the development of public health policies to mitigate these issues.

A declaração dos Principais Itens para Relatar Revisões Sistemáticas e Meta-análises (PRISMA), publicada em 2009, foi desenvolvida para ajudar revisores sistemáticos a relatar de forma transparente por que a revisão foi feita, os métodos empregados e o que os autores encontraram. Na última década, os avanços na metodologia e terminologia de revisões sistemáticas exigiram a atualização da diretriz. A declaração PRISMA 2020 substitui a declaração de 2009 e inclui novas orientações para relato que refletem os avanços nos métodos para identificar, selecionar, avaliar e sintetizar estudos. A estrutura e apresentação dos itens foram modificadas para facilitar a implementação. Neste artigo, apresentamos a lista de checagem PRISMA 2020 de 27 itens, uma lista de checagem expandida que detalha as recomendações para relato para cada item, a lista de checagem PRISMA 2020 para resumos e os fluxogramas revisados para novas revisões e para atualização de revisões.

Abstract Purpose To inform recommendations by the Canadian Task Force on Preventive Health Care on potentially inappropriate prescribing and over-the-counter (OTC) medication use among adults aged 65 years and older in primary care settings. This protocol outlines the planned scope and methods for a systematic review of the benefits and harms and acceptability of interventions to reduce potentially inappropriate prescriptions and OTC medication use. Methods De novo systematic reviews will be conducted to synthesize the available evidence on (a) the benefits and harms of interventions to reduce potentially inappropriate prescriptions and OTC medications compared to no intervention, usual care, or non- or minimally active intervention among adults aged 65 years and older and (b) the acceptability of these interventions or attributes among patients. Outcomes of interest for the benefits and harms review are all-cause mortality, hospitalization, non-serious adverse drug reactions, quality of life, emergency department visits, injurious falls, medical visits, and the number of medications (and number of pills). Outcomes for the acceptability review are the preference for and relative importance of different interventions or their attributes. For the benefits and harms review, we will search MEDLINE, Embase, and Cochrane Central Register of Controlled Trials for randomized controlled trials. For the acceptability review, we will search MEDLINE, Embase, PsycInfo, Cochrane Central Register of Controlled Trials, and the NHS Economic Evaluation Database for experimental and observational studies with a comparator. Websites of relevant organizations, other grey literature sources, and reference lists of included studies and reviews will be searched. Title and abstract screening will be completed by two independent reviewers using the liberal accelerated approach. Full-text review, data extraction, risk of bias assessments, and GRADE (Grading of Recommendations Assessment, Development and Evaluation) will be completed independently by two reviewers, with any disagreements resolved by consensus or by consulting with a third reviewer. The GRADE approach will be used to assess the certainty of the evidence for outcomes. Discussion The results of this systematic review will be used by the Canadian Task Force on Preventive Health Care to inform their recommendation on potentially inappropriate prescribing and OTC medication use among adults aged 65 years and older. Systematic review registration PROSPERO (KQ1: CRD42022302313; KQ2: CRD42022302324); Open Science Framework ( https://osf.io/urj4b/ ).

Abstract Purpose To inform updated recommendations by the Canadian Task Force on Preventive Health Care on screening for prostate cancer in adults aged 18 years and older in primary care. This protocol outlines the planned scope and methods for a series of systematic reviews. Methods Updates of two systematic reviews and a de novo review will be conducted to synthesize the evidence on the benefits and harms of screening for prostate cancer with a prostate-specific antigen (PSA) and/or digital rectal examination (DRE) (with or without additional information) and patient values and preferences. Outcomes for the benefits of screening include reduced prostate cancer mortality, all-cause mortality, and incidence of metastatic prostate cancer. Outcomes for the harms of screening include false-positive screening tests, overdiagnosis, complications due to biopsy, and complications of treatment including incontinence (urinary or bowel), and erectile dysfunction. The quality of life or functioning (overall and disease-specific) and psychological effects outcomes are considered as a possible benefit or harm. Outcomes for the values and preferences review include quantitative or qualitative information regarding the choice to screen or intention to undergo screening. For the reviews on benefits or harms, we will search for randomized controlled trials, quasi-randomized, and controlled studies in MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials. For the review on values and preferences, we will search for experimental or observational studies in MEDLINE, Embase, and PsycInfo. For all reviews, we will also search websites of relevant organizations, gray literature, and reference lists of included studies. Title and abstract screening, full-text review, data extraction, and risk of bias assessments will be completed independently by pairs of reviewers with any disagreements resolved by consensus or by consulting with a third reviewer. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach will be used to assess the certainty of the evidence for each outcome. Discussion The series of systematic reviews will be used by the Canadian Task Force on Preventive Health Care to update their 2014 guideline on screening for prostate cancer in adults aged 18 years and older. Systematic review registration This review has been registered with PROSPERO (CRD42022314407) and is available on the Open Science Framework (osf.io/dm32k).

Abstract Background The torrent of research during the coronavirus (COVID-19) pandemic has exposed the persistent challenges with reporting trials, open science practices, and scholarship in academia. These real-world examples provide unique learning opportunities for research methodologists and clinical epidemiologists-in-training. Dr. David Moher, a recognized expert on the science of research reporting and one of the founders of the Consolidated Standards of Reporting Trials (CONSORT) statement, was a guest speaker for the 2021 Hooker Distinguished Visiting Professor Lecture series at McMaster University and shared his insights about these issues. Main text This paper covers a discussion on the influence of reporting guidelines on trials and issues with the use of CONSORT as a measure of quality. Dr. Moher also addresses how the overwhelming body of COVID-19 research reflects the “publish or perish” paradigm in academia and why improvement in the reporting of trials requires policy initiatives from research institutions and funding agencies. We also discuss the rise of publication bias and other questionable reporting practices. To combat this, Dr. Moher believes open science and training initiatives led by institutions can foster research integrity, including the trustworthiness of researchers, institutions, and journals, as well as counter threats posed by predatory journals. He highlights how metrics like journal impact factor and quantity of publications also harm research integrity. Dr. Moher also discussed the importance of meta-science, the study of how research is carried out, which can help to evaluate audit and feedback systems and their effect on open science practices. Conclusion Dr. Moher advocates for policy to further improve the reporting of trials and health research. The COVID-19 pandemic has exposed how a lack of open science practices and flawed systems incentivizing researchers to publish can harm research integrity. There is a need for a culture shift in assessing careers and “productivity” in academia, and this requires collaborative top-down and bottom-up approaches.

Abstract Background Depression affects an individual’s physical health and mental well-being and, in pregnant and postpartum women, has specific adverse short- and long-term effects on maternal, child, and family health. The aim of these two systematic reviews is to identify evidence on the benefits and harms of screening for depression compared to no screening in the general adult and pregnant and postpartum populations in primary care or non-mental health clinic settings. These reviews will inform recommendations by the Canadian Task Force on Preventive Health Care. Methods We searched MEDLINE, Embase, PsycINFO, CINAHL, and the Cochrane Library using a randomized controlled trial filter, where applicable, October 4, 2018, and updated to May 11, 2020. We also searched for gray literature (e.g., websites of organizations of health professionals and patients). Study selection for depression screening trials was performed first on title and abstract, followed by full-text screening. Data extraction, assessment of the risk of bias using the Cochrane risk of bias tool, and application of Grading of Recommendations Assessment, Development and Evaluation were performed by one reviewer and validated by a second reviewer. Results A total of three trials were included. All three trials were included in the general adult review, while one of the three trials was included in the pregnant and postpartum review. We did not pool results due to substantial differences between studies and high risk of bias. In the general adult review, the first trial (n = 1001) evaluated whether screening for depression in adults with acute coronary syndrome compared to usual care improves health-related quality of life, depression symptoms, or harms of screening at 6, 12, and 18 months. There were little to no differences between the groups at 18 months for the outcomes. The second trial included adults (n = 1412) undergoing initial consultation for osteoarthritis, evaluated for depression and general health (mental and physical) after initial consultation and at 3, 6, and 12 months. The physical component score was statistically significantly lower (worse health) in the screened group at 6 months; however, this difference was not significant at 3 or at 12 months. There were no clinically important or statistically significant differences for other outcomes between groups at any time. The third trial (included in both reviews) reported on 462 postpartum women. At 6 months postpartum, fewer women in the screening group were identified as possibly depressed compared to the control group (RR 0.59, 95% confidence interval (CI) 0.39 to 0.89) and mean EPDS scores were also statistically significantly lower in the screened group (standardized mean difference 0.34 lower (95% CI 0.15 to 0.52 lower)). All other outcomes did not differ between groups at follow-up. There were serious concerns about the cut-offs used for the questionnaire used to screen, diagnostic confirmation, selective outcome reporting, and the reported magnitude of effects. Discussion There are limitations of the evidence included in the reviews. There was moderate certainty in the evidence from one trial that screening for depression in the general adult population in primary care or non-mental health clinic settings likely results in little to no difference on reported outcomes; however, the evidence was uncertain from the other two included trials. The evidence is very uncertain about the effect of screening for depression in pregnant or postpartum women in primary care or non-mental health clinic settings. Well-conducted and better-reported trials are needed that meet the screening trial criteria used in this review. Systematic review registration Both protocols have been registered in the International Prospective Registry of Systematic Reviews (PROSPERO) [adult: CRD42018099690 ; pregnancy and postpartum: CRD42018099689 ] and published ( https://systematicreviewsjournal.biomedcentral.com/track/pdf/10.1186/s13643-018-0930-3 ).

Abstract Background Determining which therapies fall under the umbrella of complementary, alternative, and/or integrative medicine (CAIM) is difficult for several reasons. An operational definition is dynamic, and changes depending on both historical time period and geographical location, with many countries integrating or considering their traditional system(s) of medicine as conventional care. We have previously reported the first operational definition of CAIM informed by a systematic search. In the present study, we have developed a comprehensive search string informed by an operational definition of CAIM for systematic bibliographic database search strategies. Methods We developed a single search string for the most common bibliographic databases, including those searchable on the OVID platform (e.g., MEDLINE, EMBASE, PsycINFO, AMED), the EBSCO platform (e.g., ERIC, CINAHL), Scopus, and Web of Science, using the finalised operational definition of CAIM’s 604 therapies. We searched the Therapeutic Research Center’s “Natural Medicines” database for all 604 therapies, and each item’s scientific name and/or synonym was included as a keyword or phrase in the search string. Results This developed search string provides a standardised list of CAIM terms (i.e., keywords and phrases) that may be searched on bibliographic databases including those found on the OVID platform (e.g., MEDLINE, EMBASE, PsycINFO, AMED), the EBSCO platform (e.g., ERIC, CINAHL), Scopus, and Web of Science. Conclusion Researchers can select relevant terms for their CAIM study and insert the keywords/phrases into these databases to receive all accessible data. This search technique can simply be copied and pasted into the search bar of each database to identify research by keywords, which is the most inclusive, or by words in the article title, which is more selective. Given its versatility across multiple commonly used academic platforms/databases, it is expected that this search string will be of great value to those conducting research on CAIM topics involving systematic search strategies.

Background: Reproducibility is a central tenant of research. We aimed to synthesize the literature on reproducibility and describe its epidemiological characteristics, including how reproducibility is defined and assessed. We also aimed to determine and compare estimates for reproducibility across different fields. Methods: We conducted a scoping review to identify English language replication studies published between 2018 and 2019 in economics, education, psychology, health sciences, and biomedicine. We searched Medline, Embase, PsycINFO, Cumulative Index of Nursing and Allied Health Literature – CINAHL, Education Source via EBSCOHost, ERIC, EconPapers, International Bibliography of the Social Sciences (IBSS), and EconLit. Documents retrieved were screened in duplicate against our inclusion criteria. We extracted year of publication, number of authors, country of affiliation of the corresponding author, and whether the study was funded. For the individual replication studies, we recorded whether a registered protocol for the replication study was used, whether there was contact between the reproducing team and the original authors, what study design was used, and what the primary outcome was. Finally, we recorded how reproducibilty was defined by the authors, and whether the assessed study(ies) successfully reproduced based on this definition. Extraction was done by a single reviewer and quality controlled by a second reviewer. Results: Our search identified 11,224 unique documents, of which 47 were included in this review. Most studies were related to either psychology (48.6%) or health sciences (23.7%). Among these 47 documents, 36 described a single reproducibility study while the remaining 11 reported at least two reproducibility studies in the same paper. Less than the half of the studies referred to a registered protocol. There was variability in the definitions of reproduciblity success. In total, across the 47 documents 177 studies were reported. Based on the definition used by the author of each study, 95 of 177 (53.7%) studies reproduced. Conclusions: This study gives an overview of research across five disciplines that explicitly set out to reproduce previous research. Such reproducibility studies are extremely scarce, the definition of a successfully reproduced study is ambiguous, and the reproducibility rate is overall modest. Funding: No external funding was received for this work

Abstract Background Systematic reviews of outcome measurement instruments are important tools in the evidence-based selection of these instruments. COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) has developed a comprehensive and widespread guideline to conduct systematic reviews of outcome measurement instruments, but key information is often missing in published reviews. This hinders the appraisal of the quality of outcome measurement instruments, impacts the decisions of knowledge users regarding their appropriateness, and compromises reproducibility and interpretability of the reviews’ findings. To facilitate sufficient, transparent, and consistent reporting of systematic reviews of outcome measurement instruments, an extension of the PRISMA (Preferred Reporting of Items for Systematic reviews and Meta-Analyses) 2020 guideline will be developed: the PRISMA-COSMIN guideline. Methods The PRISMA-COSMIN guideline will be developed in accordance with recommendations for reporting guideline development from the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network. First, a candidate reporting item list will be created through an environmental literature scan and expert consultations. Second, an international Delphi study will be conducted with systematic review authors, biostatisticians, epidemiologists, psychometricians/clinimetricians, reporting guideline developers, journal editors as well as patients, caregivers, and members of the public. Delphi panelists will rate candidate items for inclusion on a 5-point scale, suggest additional candidate items, and give feedback on item wording and comprehensibility. Third, the draft PRISMA-COSMIN guideline and user manual will be iteratively piloted by applying it to systematic reviews in several disease areas to assess its relevance, comprehensiveness, and comprehensibility, along with usability and user satisfaction. Fourth, a consensus meeting will be held to finalize the PRISMA-COSMIN guideline through roundtable discussions and voting. Last, a user manual will be developed and the final PRISMA-COSMIN guideline will be disseminated through publications, conferences, newsletters, and relevant websites. Additionally, relevant journals and organizations will be invited to endorse and implement PRISMA-COSMIN. Throughout the project, evaluations will take place to identify barriers and facilitators of involving patient/public partners and employing a virtual process. Discussion The PRISMA-COSMIN guideline will ensure that the reports of systematic reviews of outcome measurement instruments are complete and informative, enhancing their reproducibility, ease of use, and uptake.

Abstract Background Transparency and reproducibility are expected to be normative practices in clinical trials used for decision-making on marketing authorisations for new medicines. This registered report introduces a cross-sectional study aiming to assess inferential reproducibility for main trials assessed by the European Medicines Agency. Methods Two researchers independently identified all studies on new medicines, biosimilars and orphan medicines given approval by the European Commission between January 2017 and December 2019, categorised as ‘main studies’ in the European Public Assessment Reports (EPARs). Sixty-two of these studies were randomly sampled. One researcher retrieved the individual patient data (IPD) for these studies and prepared a dossier for each study, containing the IPD, the protocol and information on the conduct of the study. A second researcher who had no access to study reports used the dossier to run an independent re-analysis of each trial. All results of these re-analyses were reported in terms of each study’s conclusions, p-values, effect sizes and changes from the initial protocol. A team of two researchers not involved in the re-analysis compared results of the re-analyses with published results of the trial. Results Two hundred ninety-two main studies in 173 EPARs were identified. Among the 62 studies randomly sampled, we received IPD for 10 trials. The median number of days between data request and data receipt was 253 [interquartile range 182–469]. For these ten trials, we identified 23 distinct primary outcomes for which the conclusions were reproduced in all re-analyses. Therefore, 10/62 trials (16% [95% confidence interval 8% to 28%]) were reproduced, as the 52 studies without available data were considered non-reproducible. There was no change from the original study protocol regarding the primary outcome in any of these ten studies. Spin was observed in the report of one study. Conclusions Despite their results supporting decisions that affect millions of people’s health across the European Union, most main studies used in EPARs lack transparency and their results are not reproducible for external researchers. Re-analyses of the few trials with available data showed very good inferential reproducibility. Trial registration https://osf.io/mcw3t/

Abstract Background Identifying what therapies constitute complementary, alternative, and/or integrative medicine (CAIM) is complex for a multitude of reasons. An operational definition is dynamic, and changes based on both historical time period and geographical location whereby many jurisdictions may integrate or consider their traditional system(s) of medicine as conventional care. To date, only one operational definition of “complementary and alternative medicine” has been proposed, by Cochrane researchers in 2011. This definition is not only over a decade old but also did not use systematic methods to compile the therapies. Furthermore, it did not capture the concept “integrative medicine”, which is an increasingly popular aspect of the use of complementary therapies in practice. An updated operational definition reflective of CAIM is warranted given the rapidly increasing body of CAIM research literature published each year. Methods Four peer-reviewed or otherwise quality-assessed information resource types were used to inform the development of the operational definition: peer-reviewed articles resulting from searches across seven academic databases (MEDLINE, EMBASE, AMED, PsycINFO, CINAHL, Scopus and Web of Science); the “aims and scope” webpages of peer-reviewed CAIM journals; CAIM entries found in online encyclopedias, and highly-ranked websites identified through searches of CAIM-related terms on HONcode. Screening of eligible resources, and data extraction of CAIM therapies across them, were each conducted independently and in duplicate. CAIM therapies across eligible sources were deduplicated. Results A total of 101 eligible resources were identified: peer-reviewed articles (n = 19), journal “aims and scope” webpages (n = 22), encyclopedia entries (n = 11), and HONcode-searched websites (n = 49). Six hundred four unique CAIM terms were included in this operational definition. Conclusions This updated operational definition is the first to be informed by systematic methods, and could support the harmonization of CAIM-related research through the provision of a standard of classification, as well as support improved collaboration between different research groups.

BACKGROUND: Well-written and transparent case reports (1) reveal early signals of potential benefits, harms, and information on the use of resources; (2) provide information for clinical research and clinical practice guidelines, and (3) inform medical education. High-quality case reports are more likely when authors follow reporting guidelines. During 20112012, a group of clinicians, researchers, and journal editors developed recommendations for the accurate reporting of information in case reports that resulted in the CARE (CAse REport) Statement and Checklist. They were presented at the 2013 International Congress on Peer Review and Biomedical Publication, have been endorsed by multiple medical journals, and translated into nine languages. OBJECTIVES: This explanation and elaboration document has the objective to increase the use and dissemination of the CARE Checklist in writing and publishing case reports. ARTICLE DESIGN AND SETTING: Each item from the CARE Checklist is explained and accompanied by published examples. The explanations and examples in this document are designed to support the writing of high-quality case reports by authors and their critical appraisal by editors, peer reviewers, and readers. RESULTS AND CONCLUSION: This article and the 2013 CARE Statement and Checklist, available from the CARE website [www.care-statement.org] and the EQUATOR Network [www.equator-network.org], are resources for improving the completeness and transparency of case reports. SOURCE: This article is a translation of the original paper CARE guidelines for case reports: explanation and elaboration document in the Journal of Clinical Epidemiology (doi: 10.1016/j.jclinepi.2017.04.026), prepared under the permission of the copyright holder (Elsevier Inc.), with supervision from the Scientific Editor by Professor E.G. Starostina, MD, PhD (translator) (Moscow, Russia).

Clinical trial data-sharing is seen as an imperative for research integrity and is becoming increasingly encouraged or even required by funders, journals, and other stakeholders. However, early experiences with data-sharing have been disappointing because they are not always conducted properly. Health data is indeed sensitive and not always easy to share in a responsible way. We propose 10 rules for researchers wishing to share their data. These rules cover the majority of elements to be considered in order to start the commendable process of clinical trial data-sharing: Rule 1: Abide by local legal and regulatory data protection requirements Rule 2: Anticipate the possibility of clinical trial data-sharing before obtaining funding Rule 3: Declare your intent to share data in the registration step Rule 4: Involve research participants Rule 5: Determine the method of data access Rule 6: Remember there are several other elements to share Rule 7: Do not proceed alone Rule 8: Deploy optimal data management to ensure that the data shared is useful Rule 9: Minimize risks Rule 10: Strive for excellence.

BackgroundScholarly journals play a key role in the dissemination of research findings. However, little focus is given to the process of establishing new, credible journals and the obstacles faced in achieving this. This scoping review aimed to identify and describe existing recommendations for starting a biomedical scholarly journal.MethodsWe searched five bibliographic databases: OVID Medline + Medline in Process, Embase Classic + Embase, ERIC, APA PsycINFO, and Web of Science on January 14, 2022. A related grey literature search was conducted on March 19, 2022. Eligible sources were those published in English in any year, of any format, and that described guidance for starting a biomedical journal. Titles and abstracts of obtained sources were screened. We extracted descriptive characteristics including author name, year and country of publication, journal name, and source type, and any recommendations from the included sources discussing guidance for starting a biomedical journal. These recommendations were categorized and thematically grouped.ResultsA total of 5626 unique sources were obtained. Thirty-three sources met our inclusion criteria. Most sources were blog posts (10/33; 30.30%), and only 10 sources were supported by evidence. We extracted 51 unique recommendations from these 33 sources, which we thematically classified into nine themes which were: journal operations, editorial review processes, peer review processes, open access publishing, copyediting/typesetting, production, archiving/indexing/metrics, marketing/promotion, and funding.ConclusionsThere is little formal guidance regarding how to start a scholarly journal. The development of an evidence-based guideline may help uphold scholarly publishing quality, provide insight into obstacles new journals will face, and equip novice publishers with the tools to meet best practices.

The state of open science needs to be monitored to track changes over time and identify areas to create interventions to drive improvements. In order to monitor open science practices, they first need to be well defined and operationalized. To reach consensus on what open science practices to monitor at biomedical research institutions, we conducted a modified 3-round Delphi study. Participants were research administrators, researchers, specialists in dedicated open science roles, and librarians. In rounds 1 and 2, participants completed an online survey evaluating a set of potential open science practices, and for round 3, we hosted two half-day virtual meetings to discuss and vote on items that had not reached consensus. Ultimately, participants reached consensus on 19 open science practices. This core set of open science practices will form the foundation for institutional dashboards and may also be of value for the development of policy, education, and interventions.

Abstract Background The demand for peer reviewers is often perceived as disproportionate to the supply and availability of reviewers. Considering characteristics associated with peer review behaviour can allow for the development of solutions to manage the growing demand for peer reviewers. The objective of this research was to compare characteristics among two groups of reviewers registered in Publons. Methods A descriptive cross-sectional study design was used to compare characteristics between (1) individuals completing at least 100 peer reviews (‘mega peer reviewers’) from January 2018 to December 2018 as and (2) a control group of peer reviewers completing between 1 and 18 peer reviews over the same time period. Data was provided by Publons, which offers a repository of peer reviewer activities in addition to tracking peer reviewer publications and research metrics. Mann Whitney tests and chi-square tests were conducted comparing characteristics (e.g., number of publications, number of citations, word count of peer review) of mega peer reviewers to the control group of reviewers. Results A total of 1596 peer reviewers had data provided by Publons. A total of 396 M peer reviewers and a random sample of 1200 control group reviewers were included. A greater proportion of mega peer reviews were male (92%) as compared to the control reviewers (70% male). Mega peer reviewers demonstrated a significantly greater average number of total publications, citations, receipt of Publons awards, and a higher average h index as compared to the control group of reviewers (all p .428). Conclusions Mega peer reviewers registered in the Publons database also had a higher number of publications and citations as compared to a control group of reviewers. Additional research that considers motivations associated with peer review behaviour should be conducted to help inform peer reviewing activity.

Predatory journals are journals that do not adhere to best editorial and publication practices. They often provide false or misleading information. Similarly, predatory journals have a long history of sending often aggressive and indiscriminate invitations to submit articles to them. Finally, these journals lack transparency regarding their operations. There are a large number of predatory journals that include hundreds of thousands of articles, including millions of participants who have participated in clinical research and thousands of animals included in preclinical research. The quality of reporting of these articles is disturbingly low. Unfortunately, these articles have been included in systematic reviews, meta-analyses and health policy documents. The extent to which the inclusion of these articles influence clinical practice guidelines and health policy is unknown. It is unlikely to be a zero influence. Similarly, these articles have managed to leak into what is considered trusted resources, such as PubMed. To combat the proliferation of predatory publishers and journals requires collaborative efforts on the part of many groups. Researchers need more education and resources about predatory journals. They need to be cautioned about responding to the aggressive and unsolicited E-mails they receive from these journals. Funders need to be more explicit about not allowing the use of article processing fees for publishing in predatory journals. Universities, other research organizations, and their respective libraries need to enhance their outreach concerning the problems of predatory journals and publishers. Similarly, there needs to be stronger guards against using publications from predatory journals in hiring, promotion and tenure portfolios. Finally, the research ecosystem should move away from conceptualizing whether journals are predatory or not, to a more nuanced view whereby journals and publishers are judged on their practices-high risk to lower risk.

This is the introductory paper in a collection of four papers on the Strategy for Patient-Oriented Research (SPOR) Evidence Alliance, a pan-Canadian research initiative that was funded by the Canadian Institutes of Health Research in September of 2017. Here, we introduce the SPOR enterprise in Canada, provide a rationale for the creation of the SPOR Evidence Alliance, provide information on the mandate and approach, and describe how the SPOR Evidence Alliance adds to the health research ecosystem in Canada and beyond.