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Brazilian Oral Research, Volume: 34 Suplemento 2, Publicado: 2020
  • Challenges of clinical research in dentistry Editorial

    PANNUTI, Cláudio Mendes; ROMITO, Giuseppe Alexandre; PAIVA, Saul Martins
  • Non-inferiority clinical trials: importance and applications in health sciences Original Research

    HONÓRIO, Heitor Marques; WANG, Linda; RIOS, Daniela

    Resumo em Inglês:

    Abstract Non-inferiority randomized clinical trials are indicated when it is intended to prove that an experimental group is not inferior to a control group by more than a margin of non-inferiority. However, this type of study differs from traditional randomized clinical trials (superiority studies) because they have particularities that impact on the formulation of hypothesis to be tested, experimental design (non-inferiority margin determination, adapted sample size calculation, sensitivity of the study and data final analysis) and also on the presentation of data when writing the manuscript. Therefore, this article aims to present and discuss the particularities of non-inferiority clinical studies, since these requirements are fundamental to guarantee the validity of the conclusions of this type of study.
  • Practice based research in dentistry: an alternative to deal with clinical questions Critical Review

    DEMARCO, Flávio Fernando; CORREA, Marcos Britto; CENCI, Maximiliano Sérgio; BURKE, Frederick James Trevor; OPDAM, Niek Johannes Maria; FARIA-E-SILVA, Andre Luis

    Resumo em Inglês:

    Abstract Clinical interventions in dental practice should be determined based on the best scientific evidence available. Well-designed randomized clinical trials (RCTs) provide important evidence supporting the efficacy of interventions and are usually considered as the best primary evidence. However, the strict criteria adopted by most RCTs reduce their external validity since some findings from these studies might not work under usual conditions. On the other hand, practice-based research (PBR) studies have been designed to better define the effectiveness of clinical interventions under settings closer to “real-world” conditions. Therefore, this review aimed to describe different PBR designs discussing some advantages and limitations of such studies. The stimulus to organization PBR networks is discussed since the studies performed by these networks involve large number of clinicians and important conclusions can be drawn. Designs of observational studies including surveys and cohort studies based on practice are presented. Survey methods are important to know the behavior of practitioners regarding diagnostic and decision of treatment. Cohorts allow assessing different cofounders contributing to some outcome since large sample sizes and long follow-up periods can be observed in some of these studies. Pragmatic trials designed to take place in real-world clinical practice settings are also discussed as a useful design to assess the effectiveness of clinical interventions. In conclusion, this review sought to present PBR studies as alternative designs to answer clinical questions, but not replacing randomized clinical trials.
  • Clinically relevant outcomes in dental clinical trials: challenges and proposals Critical Review

    PANNUTI, Claudio Mendes; SENDYK, Daniel Isaac; GRAÇAS, Yasmin Teixeira das; TAKAI, Sandra Lie; SABÓIA, Vicente de Paulo Aragão; ROMITO, Giuseppe Alexandre; MENDES, Fausto Medeiros

    Resumo em Inglês:

    Abstract The impact of clinical trials on patient care depends on the outcomes that they evaluate. In Dentistry, many trials use outcomes that are important to clinicians, but not to the patients. Thus, the aim of the present manuscript is to present an overview of the limitations, challenges, and proposals on the use of clinically relevant outcomes (CRO) in dental trials. Clinically relevant outcomes are variables that directly measure how the patient feels, functions, or survives. Some CROs, such as tooth loss, implant failure, and restorations failure require many years to occur and the number of events is low. The adoption of these variables as primary outcomes results in challenges for the researchers, such as use of large sample sizes and long follow-up periods. Surrogate outcomes, such as biomarkers, radiographic measurements and indexes, are frequently used to replace CROs. However, they present many limitations, since the effect of the treatment on a surrogate does not necessarily reflect a change in the clinical outcome. Some proposals for the adoption of CROs are presented, such as the development of core outcome sets within each dental specialties and the organization of multi-center clinical trials.
  • Surrogate endpoints: when to use and when not to use? A critical appraisal of current evidences Critical Review

    Vinicius, PEDRAZZI; FIGUEIREDO, Fellipe Augusto Tocchini de; ADAMI, Larisse Eduardo; FURLANETO, Flávia; PALIOTO, Daniela Bazan; MESSORA, Michel Reis

    Resumo em Inglês:

    Abstract Clinical research needs to formulate a question, which must be answered by obeying ethical precepts with well-defined inclusion/exclusion criteria and approval of the study on platforms of ethical appreciation and clinical trial records. In comparing the results or clinically relevant outcomes should be prioritized in the study of techniques, products, inputs, drugs and therapies. However, it is not always possible to use long study drawings, with many participants, and with many costs, then look for study designs with surrogate outcomes, usually a shorter path, with less sample size and considerably lower costs to the research, with shorter intervention time. Considering these outcomes as major challenges in clinical research, the premise of this work was to examine in relevant research platforms, studies on the feasibility of using surrogate endpoints for clinically relevant parameters in dentistry, with a critical evaluation of the advantages, disadvantages, and need for validation of substitute parameters for clinical studies. After a critical analysis of the results, it could be concluded that surrogate endpoints may have an important role in the initial process of developing new drugs, faster, with less sampling, and lower risk of side effects for the patient. Careful use of the surrogate endpoints is advised because, even if validated, they can provide ambiguous evidence and not be extrapolated to other populations, and may lead to bias due to the individual interpretation of each researcher. The use of unplanned surrogate outcomes that arise during the study requires a lot of caution.
  • Patient-centered assessments: how can they be used in dental clinical trials? Critical Review

    PERAZZO, Matheus França; SERRA-NEGRA, Júnia Maria; FIRMINO, Ramon Targino; PORDEUS, Isabela Almeida; MARTINS-JÚNIOR, Paulo Antônio; PAIVA, Saul Martins

    Resumo em Inglês:

    Abstract Recently, there has been greater interest in adopting a more holistic approach to healthcare. However, this trend should not limit itself merely to the notion that a human being lies behind the mouth being treated. Rather, it should embrace the understanding that this human can actively participate in and contribute to the treatment process. Patient Report Outcome Measures (PROMs) and Patient Report Experience Measures (PREMs) provide means for measuring data from the patient’s perspective, and enable health-related feelings and functions to be evaluated. Accordingly, this critical review aims to provide definitions, rationales and applications of patient-centered approaches in dental clinical research. Some patient-centered constructs are especially relevant to dental clinical trials, such as oral health-related quality of life, pain/discomfort, aesthetics and satisfaction concerning treatment and services. The selection and application of patient-reported measures can vary according to condition (generic, disease-specific or treatment-specific) and to the specific population evaluated (age and cognitive impairment). These measures can help weigh risks and benefits, as well as assess the cost effectiveness of treatments, thus influencing treatment recommendations and health policies. The incorporation of these measures into a professional’s daily life not only represents an improvement in professional performance, but also addresses a humanitarian concern.
  • How can we associate an economic evaluation with a clinical trial? Critical Review

    BRAGA, Mariana Minatel; MACHADO, Gabriela Manco; ROCHA, Elizabeth Souza; VIGANÓ, Maria Eduarda; PONTES, Laura Regina Antunes; RAGGIO, Daniela Prócida

    Resumo em Inglês:

    Abstract Economic evaluations in Dentistry have been increasing in recent years. They are a relevant contribution if an economic issue exists. Knowing if a new intervention is an efficient way of allocating available (and scarce) resources (the concept of opportunity costs), a well-designed economic evaluation may be helpful. One option is to conduct a trial-based economic analysis, which extracts a considerable board of information from a trial. This approach produces a more controlled result since many sources of variations might be reduced. On the other hand, some aspects could not be predicted directly from the trial or even extrapolated. Thus, combining model-based analysis may be an idea. In this paper, we intended to discuss important aspects to be considered by researchers in further economic evaluations. This paper will be systematically divided into sessions related to the study design as time horizon and perspective, health effects, costs, and data analysis. In the end, we expect the reader could be able to plan a trial-based economic evaluation, which should be a careful, meticulous, quite laborious and especially transparent process.
  • Clinical trials sponsored by industry and other private organizations Critical Review

    CORTELLI, Sheila Cavalca; COSTA, Fernando Oliveira; LOUSANA, Greyce; QUINTAIROS, Paulo Cesar Ribeiro; FRANCISCONI-DOS-RIOS, Luciana Fávaro; CORTELLI, José Roberto

    Resumo em Inglês:

    Abstract The present manuscript discussed some relevant aspects related to private sponsored clinical trials in dentistry. For decades, the academy has been the major responsible for research in Brazil. Distant from the trade sector, academic research has not always provided clear benefits to society. A key aspect of making benefits clearer is the process of scientific knowledge transference to decision-makers, which is, in fact, the ground of evidence-based dentistry. Although private sponsoring of clinical research seems to be part of the research progress of the business rates, investment in Brazil is lower than those observed in other countries. It is particularly important to understand that instead of creating its own rules, dentistry imported the high-quality standards originally designed for pharmaceutical studies. Therefore, it is critical to understand the original rules and how dental items are classified by regulatory agencies. In fact, knowledge about international and local regulation is a basic assumption in industry-sponsored research. Despite globalization, the identification of industry-sponsored studies through open access databases is still very hard and time-demanding. A common concern when conducting industry-sponsored trials is study biases. Fortunately, many relevant organizations, academic and industry groups, have been working seriously against that. Finally, for less experienced researchers, many aspects related to industry-sponsored studies – such as confidentiality, authorship, budget – are deeply discussed until a final version of the trial agreement can be written and signed, protecting all sides. In short, the scenario should be improved, but it already represents a nice opportunity for dental research.
  • Risk communication in the context of clinical research Critical Review

    NADANOVSKY, Paulo; COSTA, Luciane Rezende; SANTOS, Ana Paula Pires dos

    Resumo em Inglês:

    Abstract Physicians and dentists usually make clinical decisions and recommendations without a clear understanding of the meaning of the numbers regarding the accuracy of diagnostic tests and the efficacy of treatments. This critical review aimed to identify problems in the communication of diagnostic test accuracy and treatment benefits and to suggest strategies to improve risk communication in these contexts. Most clinical decisions are taken under uncertainty. Health professionals cannot predict the outcome in one individual patient. This uncertainty invites these professionals to make decisions based on heuristics, which gives rise to several cognitive biases. Cognitive biases are automatic and unconscious, so how is it possible to mitigate their undesirable effects on risk interpretation in the context of clinical practice? Some forms of risk communication reinforce cognitive bias, while others weaken them. Maybe one of the most difficult obstacles to overcome is the difficulty to think with numbers. This difficulty probably arises from a mismatch of ancestral adaptations of the brain having to deal with modern environments, which are quite different from the ancestral ones. There are two quite common, but bad, forms of risk communication: the conditional probability and the relative risk reduction or efficacy. People, including physicians and dentists, are confused with this kind of information. The main methods discovered so far to facilitate a clearer understanding are to emphasize the base rates of the events and to use absolute numbers, that is to use natural frequencies, instead of percentages and conditional probabilities.
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