Primary outcomes and characteristics of clinical trial registries (up to October 2021) on COVID-19 vaccines.

OBJECTIVES: To analyse the general and primary outcome-related characteristics of clinical trials protocols on COVID-19 vaccines. STUDY DESIGN AND SETTING: A meta-research study. A search for clinical trial protocols on COVID-19 vaccines was conducted on the ClinicalTrials.gov platform. We considered all protocols of comparative trials registered up to October 26, 2021. RESULTS: Two hundred and eighty-two trials were analysed. The median expected trial duration was 445 days (interquartile range [IQR] = 225), and the median target sample size was 420 participants (IQR = 1638). A retrospective registry (after the start date) was observed for 42.55% of the trials. Randomization procedures were planned by 84.75% and full-blinding procedures by 34.75% of the 282 trials. Most trials were labelled as active or still recruiting, and 14 trials (5%) were completed. None of the 14 trials labelled as completed on our search date had results available. Industry funding was reported by 198 trials (70.2%). Most studies declared more than one primary outcome, usually a safety or immunogenicity outcome, and 59 studies (20.9%) had at least one primary efficacy outcome. The description of the primary efficacy outcomes was limited in most cases, referred to as a non-specified 'efficacy' outcome (18.6%) or described as 'COVID-19 cases' (32.2%). CONCLUSION: the primary outcomes of clinical trials on COVID-19 vaccines are poorly described, and the registers provide insufficient information about them. The registry was retrospectively fulfilled for many trials, which may lead to bias and research waste. Outcomes were generically described and did not provide transparent information for replication in practice, further trials or meta-analyses.

Do the clinical practice guidelines for paediatric dentistry meet the quality standards? A meta-research and quality appraisal using the AGREE II tool.

BACKGROUND: Clinical practice guidelines (CPGs) enhance health care and aid clinicians' decisions. AIM: To evaluate the quality of clinical guidelines in paediatric dentistry using the AGREE II tool. DESIGN: PubMed, EMBASE, Scopus, LIVIVO, Lilacs, international guidelines websites, scientific societies, and gray literature were searched until September 2021. We included paediatric dental clinical guidelines and excluded drafts or guidelines for patients with special needs. Two independent reviewers performed quality assessment using the APPRAISAL OF GUIDELINES FOR RESEARCH & EVALUATION II (AGREE II) instrument. We calculated the mean overall domain scores (95% confidence interval) for each guideline. We used regression analysis to correlate the score of overall assessment and the six domains of AGREE II with guideline characteristics. RESULTS: Forty-four guidelines were included in this study. Highest mean score was for Domain 4 (Clarity of Presentation; 58%, 95% CI: 50.8-64.9), whereas the lowest was for Domain 5 (Applicability; 16%, 95% CI: 10.8-21.4). The reporting quality was improved in Domains 1-5 with reporting checklists (p < .001), whereas that of Domain 6 was improved by decreasing years since publication (p = .047). CONCLUSION: Paediatric dental guidelines do not comply with the methodological quality standard, especially in Domain 5 (Applicability). The AGREE reporting checklist should be implemented with a system to evaluate the certainty of evidence for future guidelines.

Credibility at stake: only two-thirds of randomized trials of nutrition interventions are registered and lack transparency in outcome and treatment effect definitions.

OBJECTIVES: This study aimed to investigate the adherence of randomized controlled trials of nutrition interventions to transparency practices informing assessments of selective reporting biases, including the availability of a trial registration entry, protocol and statistical analysis plan (SAP). STUDY DESIGN AND SETTING: Retrospective observational study with cross-sectional design. We systematically searched for trials published from 1 July 2019, to 30 June 2020, and included a randomly selected sample of 400 studies. We searched for registry entries, protocols, and SAPs for all included studies. We extracted data to characterize the disclosure of sufficient information in the available materials to inform assessments of selective reporting biases, considering the definition of outcome domain, measure, metric, method of aggregation, time point, analysis population, methods to handle missing data and method of adjustment. RESULTS: Most trials (69%) were registered, but these often lacked sufficient specification of outcomes and intended treatment effects. Protocols and SAPs provided more details but were less often available (14% and 3%, respectively), and even then, almost all studies presented limited information to inform the assessments of risk of bias due to the selection of the reported result. CONCLUSION: Lack of full specification of outcomes and intended treatment effects hinder a full adherence of randomized controlled trials of nutrition interventions to transparency practices and may affect their credibility.

Adherence to the PRISMA statement and its association with risk of bias in systematic reviews published in rehabilitation journals: A meta-research study.

BACKGROUND: Systematic reviews (SRs) and meta-analyses are essential resources for the clinicians. They allow to evaluate the strengths and the weaknesses of the evidence to support clinical decision-making if they are adequately reported. Little is known in the rehabilitation field about the completeness of reporting of SRs and its relationship with the risk of bias (ROB). OBJECTIVES: Primary: 1) To evaluate the completeness of reporting of systematic reviews (SRs) published in rehabilitation journals by evaluating their adherence to the PRISMA 2009 checklist, 2) To investigate the relationship between ROB and completeness of reporting. Secondary: To study the association between completeness of reporting and journals and study characteristics. METHODS: A random sample of 200 SRs published between 2011 and 2020 in 68 rehabilitation journals was indexed under the "rehabilitation" category in the InCites database. Two independent reviewers evaluated adherence to the PRISMA checklist and assessed ROB using the ROBIS tool. Overall adherence and adherence to each PRISMA item and section were calculated. Regression analyses investigated the association between completeness of reporting, ROB, and other characteristics (impact factor, publication options, publication year, and study protocol registration). RESULTS: The mean overall PRISMA adherence across the 200 studies considered was 61.4%. Regression analyses show that having a high overall ROB is a significant predictor of lower adherence (B=-7.1%; 95%CI -12.1, -2.0). Studies published in fourth quartile journals displayed a lower overall adherence (B= -7.2%; 95%CI -13.2, -1.3) than those published in first quartile journals; the overall adherence increased (B= 11.9%; 95%CI 5.9, 18.0) if the SR protocol was registered. No association between adherence, publication options, and publication year was found. CONCLUSION: Reporting completeness in rehabilitation SRs is suboptimal and is associated with ROB, impact factor, and study registration. Authors of SRs should improve adherence to the PRISMA guideline, and journal editors should implement strategies to optimize the completeness of reporting.

Spin and reporting in systematic reviews with meta-analysis of randomized clinical trials in restorative dentistry.

OBJECTIVE: To estimate the prevalence of spin and completeness of reporting of systematic reviews with metanalysis (SRMAs) in restorative dentistry. METHODS: Inclusion criteria were SRMAs of randomized clinical trials of restorative dentistry on survival, success, or failure rates of treatment in humans, with no language or year restriction. SRMAs performed with non-RCTs were excluded. PubMed/MEDLINE, Web of Science, Scopus, Embase, and Cochrane Collaboration Library were searched from inception to April 2022. Outcomes were the prevalence of spin (primary outcome) and completeness of reporting (secondary outcome) in the abstract and full text. Data were reported through means and standard deviations or absolute and relative frequencies. Spin in each item was considered low when occurring in less than 25% of the papers, moderate (25 to 75%), or high (more than 75%). RESULTS: We identified 7029 studies and 49 unique manuscripts were included. There was a moderate presence of spin in the abstracts and low in full texts. In the abstracts, 65.9% did not report adverse events; while in the abstract and full text, more than 16% reported a conclusion containing recommendations for clinical practice not supported by the findings. Regarding completeness of reporting, there was poor reporting for most items in the abstract while there was an adequate report in full texts, except for register name and registration number (not reported in 32.7%). CONCLUSIONS: Abstract of SRMAs in restorative dentistry should be better reported. Spin and poor reporting were more frequent in the abstracts, which misleads readers and could lead to inadequate clinical recommendations. CLINICAL SIGNIFICANCE: Spin and incomplete reporting are a threat to evidence-based practice, especially in systematic reviews. Therefore, care providers, researchers, and other stakeholders should be aware of the possibility of spin in systematic reviews and other sources to prevent misinterpretation, which could lead to inadequate decisions and treatments.

Questionable research practices among Brazilian psychological researchers: Results from a replication study and an international comparison.

Research on scientific integrity is growing in psychology, and questionable research practices (QRPs) have received more attention due to its harmful effect on science. By replicating the procedures of previous research, the present study aimed at describing the use of QRPs among Brazilian psychological researchers and to make an international comparison with previous studies in other countries-the US and Italy. Two hundred and thirty-two Brazilian researchers in the field of psychology answered questions related to 10 different QRPs. Brazilian researchers indicated a lower tendency to engage in two QRPs (failing to report all of a study's dependent measures; deciding whether to collect more data after looking to see whether the results were significant) when compared to their Italian and North American counterparts, but indicated a higher tendency to engage in two other QRPs (selectively reporting studies that "worked"; not reporting all of a study's conditions). Most of the sample did not admit integrity conflicts in their own research but indicated that others have integrity problems, as observed in previous studies. Those discrepancies could be attributed to contextual and systemic factors regarding different publication demands among the different nations. Further studies should focus on identifying the antecedents of QRPs.

A noção de discurso na pesquisa em saúde coletiva: de recurso metodológico à abordagem teórica / The notion of discourse in research on collective health: from methodological resource to theoretical approach / La noción de discurso en la investigación en salud colectiva: de recurso metodológico a enfoque teórico

Resumo A difusão das metodologias de pesquisa qualitativa no campo da Saúde Coletiva tem sido acompanhada da expansão do uso das abordagens discursivas, cujos efeitos têm mobilizado os pesquisadores da área, seja na crítica aos abusos e fragilidades epistemológicas de sua apropriação, na diferenciação entre as correntes de análise do discurso seja na defesa de novas perspectivas de investigação. Neste texto, apresenta-se uma discussão sobre as formas de uso da noção de discurso no campo, partindo-se da análise de uma amostra de 230 artigos publicados por autores brasileiros entre os anos 2014 e 2018, em dez periódicos selecionados na base SciELO Saúde Pública. Caracterizado como um estudo de metapesquisa, dá destaque aos referenciais teórico-epistemológicos, abordagens discursivas e universos temáticos a que os artigos se filiam. A multiplicidade de vertentes é interpretada como expressão das diferentes tradições incorporadas por meio da tradução realizada no campo. A prevalência do uso metodológico, no sentido de conjunto de regras e técnicas de pesquisa, sugere a instrumentalização e exploração incipiente da noção de discurso. Finaliza-se com argumentação em favor da potencialidade das abordagens discursivas pós-estruturais - e, em particular a Teoria do Discurso de Ernesto Laclau e Chantal Mouffe - para as investigações no campo da Saúde Coletiva.

Abstract The dissemination of qualitative research methodologies in the field of Collective Health has been followed by the expansion in the use of discursive approaches. The effects of this increase have mobilized researchers in this field, be it through criticism of the epistemological abuses and weaknesses of its appropriation, through the distinction among the different schools of discourse analysis, or through the support of new research perspectives. In this article, I present a discussion about the ways to use the notion of discourse on the field, based on an analysis of a sample of 230 articles published by Brazilian authors between the 2014 and 2018, in 10 journals selected in the SciELO Public Health database. Characterized as a meta-research study, it highlights the theoretical-methodological frameworks, the discursive approaches, and the thematic universes to which the articles are affiliated. The multiplicity of perspectives is interpreted as an expression of the different traditions assimilated through the translation performed on the field. The prevalence of the methodological use, in the sense of a set of research rules and techniques, suggests the instrumentalization and incipient exploration of the notion of discourse. I end with an argument in favor of the potentiality of the post-structural discursive approaches -, and, in particular, with the Theory of Discourse by Ernesto Laclau and Chantal Mouffe - for the research in the field of Collective Health.

Resumen La difusión de las metodologías de investigación cualitativa en el campo de la Salud Colectiva ha sido acompañada de la expansión del uso de los enfoques discursivos. Los efectos de este incremento han movilizado los investigadores del área, sea en la crítica a los abusos y fragilidades epistemológicas de su apropiación, en la diferenciación entre las corrientes de análisis del discurso, o en la defensa de nuevas perspectivas de investigación. En este artículo, presento una discusión sobre las formas de uso de la noción de discurso en campo, con base en un análisis de una muestra de 230 artículos publicados por autores brasileños entre 2014 y 2018, en diez periódicos seleccionados en la base de datos SciELO Salud Pública. Caracterizado como un estudio de metainvestigación, que resalta los referenciales teórico-epistemológicos, los enfoques discursivos, y los universos temáticos a los que están afiliados los artículos. La multiplicidad de vertientes es interpretada como expresión de las diferentes tradiciones incorporadas por medio de la traducción realizada en campo. La prevalencia del uso metodológico, en el sentido de un conjunto de reglas y técnicas de investigación, sugiere la instrumentalización y la exploración incipiente de la noción de discurso. Finalizo con un argumento en favor de la potencialidad de los enfoques discursivos post-estructurales - y en particular la Teoría del Discurso de Ernesto Laclau y Chantal Mouffe - para las investigaciones en el campo de la Salud Colectiva.