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GRADE system, systematic and transparent evaluation
Sistema GRADE, evaluación sistemática y transparente
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"correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Sistema GRADE, evaluación sistemática y transparente" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">In recent years, the GRADE system (Grade of Recommendation, Assessment, Development and Evaluation) has been utilized in the publication of guidelines and recommendations, mostly concerning treatment, both with drug and non-drug therapies in different areas of medicine.<a class="elsevierStyleCrossRefs" href="#bib0130"><span class="elsevierStyleSup">1–3</span></a> Very recently, a number of clinical practice guidelines in the field of rheumatology have employed this system, including guidelines dealing with polymyalgia rheumatica, rheumatoid arthritis and fibromyalgia, among others.<a class="elsevierStyleCrossRefs" href="#bib0145"><span class="elsevierStyleSup">4–8</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Evidence-based medicine facilitates headway in this uncertain terrain and aid in clinical decision making. Evidence-based guidelines have undergone a profound transformation in recent years. There are a number of systems to evaluate scientific evidence and assign different grades of recommendation. However, these systems have certain drawbacks, as they do not include a balance of risks and benefits, nor do they take into account resource use or costs, and the fact that they were mostly developed by consensus of expert opinion and have not been validated. Clinical practice guideline panel members can have strong opinions or academic biases concerning a specific area in which they have clinical experience or other biases with respect to interactions with academic colleagues or coworkers in the industry.<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">9</span></a> In an attempt to address these problems, GRADE requires systematic and pragmatic searches of the literature and summarizing the evidence, ideally based on grouped treatment effects and produced by panel members with no conflicts of interest or independent methodologists. The latter helps to ensure an impartial and reproducible evaluation of the literature addressing a specific clinical question.</p><p id="par0015" class="elsevierStylePara elsevierViewall">The GRADE working group is a multidisciplinary international collaboration of experts in developing a common, transparent and sensible system for rating quality of evidence and the strength of recommendations.<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">10</span></a> The GRADE system has been adopted by more than 80 agencies and organizations recognized worldwide, such as the World Health Organization (WHO), the Cochrane Collaboration Group, the United Kingdom National Institute for Health, and the National Institute for Health and Clinical Excellence (NICE), among others.</p><p id="par0020" class="elsevierStylePara elsevierViewall">In the development of GRADE, the authors considered a wide range of clinical questions, including diagnosis, screening, prevention and treatment. To go from a generic clinical question to one specifically formulated in such a way that it facilitates literature searches and the drafting of recommendations for each question, the method referred to as Patients – Intervention – Comparison – Outcome (PICO) was preferred. On drawing up the clinical questions in PICO format, the issue is specifically defined, without ambiguity. Moreover as each type of question corresponds to a type of study in which the design is suitable for the response. The format aids in doing a literature search.<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">11</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">The advantages of the GRADE approach are that it: (a) carefully considers the relative importance of the outcome variables and selects those that are most significant; (b) provides detailed descriptions of the criteria for quality of evidence with respect to specific results or outcomes and uses explicit definitions and sequential judgements during the categorization process; (c) separates the quality of evidence from the strength of the recommendations; and (d) moreover, considers the balance between benefits and risks, patient values and resource use or costs. It also provides tables showing the so-called evidence profiles (EP) and summary of findings (SoF). Finally, software has been developed, with its associated help files, that facilitate the development of EP and SoF tables based on EP.<a class="elsevierStyleCrossRefs" href="#bib0185"><span class="elsevierStyleSup">12,13</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">The GRADE system is composed of 8 criteria to evaluate quality of evidence; 5 of the 8 criteria are capable of downgrading quality of evidence, even in a randomized controlled trial (RCT): risk of biases, inconsistency of the results across studies, indirectness, imprecision and publication biases.<a class="elsevierStyleCrossRefs" href="#bib0195"><span class="elsevierStyleSup">14,15</span></a> For example, a RCT conducted with inadequate blinding of the sequence and with a high rate of dropouts should not be considered equivalent to a well-performed RCT. Moreover, 3 more criteria were proposed with the potential to increase confidence: a strong association without confounders, the existence of a dose–response gradient based on studies without the problems of biases or imprecisions and the evidence that all the possible confounders or biases could have reduced the observed effect.<a class="elsevierStyleCrossRef" href="#bib0205"><span class="elsevierStyleSup">16</span></a> Thus, an observational report like a case–control study with a strong association, demonstrating a dose-response gradient, which in other circumstances would suggest a weak design, with the GRADE approach would produce evidence at the level of a RCT. The GRADE method proposes 4 levels to express the quality of evidence: high, moderate, low and very low.<a class="elsevierStyleCrossRef" href="#bib0195"><span class="elsevierStyleSup">14</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">The first GRADE criterion, risk of bias or design limitations, is conceptually a matter of the internal validity of a scientific study. The degree of risk of bias can be determined by a careful reading of the methods section of each original study and evaluating how well the authors carried out the planning and performance of the study.<a class="elsevierStyleCrossRef" href="#bib0210"><span class="elsevierStyleSup">17</span></a> There is evidence in medicine that methodological imperfections in a RCT can have an influence on the estimated effect, which is usually exaggerated.<a class="elsevierStyleCrossRef" href="#bib0215"><span class="elsevierStyleSup">18</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">The second criterion, inconsistency of the results across the studies included in a systematic review, signifies that the results deviate from one another, and this naturally leads to decreased confidence in the effectiveness of the estimate. If the original studies are clinically homogeneous (responding to the question posed by the investigation) and the methodological quality is high, but the results are inconsistent, then statistical analyses will probably demonstrate that there is heterogeneity in the results.<a class="elsevierStyleCrossRef" href="#bib0220"><span class="elsevierStyleSup">19</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">The third GRADE criterion, imprecision or absence of direct evidence, refers to any deviation from the research question of the studies included in the systematic review. In cases of the absence of direct comparisons between the interventions being considered, or of substantial differences between the available studies and the population, the interventions or outcomes put forward in the question of interest, we may find that we only have access to indirect information. The use of surrogate outcomes may not be associated with the primary outcome. This may cause problems of applicability.<a class="elsevierStyleCrossRef" href="#bib0225"><span class="elsevierStyleSup">20</span></a></p><p id="par0050" class="elsevierStylePara elsevierViewall">The fourth GRADE criterion, imprecision, conceptually reflects the random variation in the estimate of the outcome and is different from the internal validity. If the original studies in a systematic review are clinically homogeneous and all of them have a low risk of bias, it is appropriate to conduct a meta-analysis and obtain an overall estimate. The 95% confidence interval (CI) is frequently interpreted to signify that, with a certainty of 95%, the true value of a parameter can be found within the given range. The information on the width of this interval can be used as the basis for clinical inference. For example, this enables the conclusion that the CI have exceeded the clinically important minimal difference.<a class="elsevierStyleCrossRef" href="#bib0230"><span class="elsevierStyleSup">21</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">The fifth GRADE criterion, which can reduce the confidence in the results of a systematic review, is publication bias. The selective report of outcomes is a matter of the internal validity of a given study, and should be included in the criteria for “limitations for study quality”. When individual studies are not published, there can be biases in systematic reviews. The existence of publication biases is one of the potential sources of risk of bias in systematic reviews. The obligatory risk of registry of clinical trials has enhanced the possibilities of identifying publication bias.<a class="elsevierStyleCrossRef" href="#bib0235"><span class="elsevierStyleSup">22</span></a></p><p id="par0060" class="elsevierStylePara elsevierViewall">We must recognize that the system has certain limitations; thus, firstly, the method was initially developed to respond to questions on alternative interventions, especially for treatment or prevention, not for risk or prognosis, and it has problems with respect to diagnostic tests, public health issues and health care systems. However, in recent years, adaptations of this method have been designed for diagnostic<a class="elsevierStyleCrossRef" href="#bib0240"><span class="elsevierStyleSup">23</span></a> and prognostic studies,<a class="elsevierStyleCrossRef" href="#bib0245"><span class="elsevierStyleSup">24</span></a> which are now being used in systematic reviews. Secondly, although the system employs highly systematic, transparent and reproducible judgements, it does not completely eliminate possible disagreements in the evaluation of evidence or in deciding alternative courses, given that there is always a subjective impregnation in every judgement. Finally, we should point out that a number of researchers analyzing complex systematic reviews have identified difficulties in applying the criteria for the evaluation of quality using GRADE in complex interventions.<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">25</span></a></p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "." "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Mendoza Pinto C, García Carrasco M. Sistema GRADE, evaluación sistemática y transparente. 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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 2 | 2 | 4 |
| 2024 October | 34 | 33 | 67 |
| 2024 September | 35 | 18 | 53 |
| 2024 August | 42 | 46 | 88 |
| 2024 July | 30 | 28 | 58 |
| 2024 June | 40 | 28 | 68 |
| 2024 May | 51 | 34 | 85 |
| 2024 April | 46 | 23 | 69 |
| 2024 March | 44 | 37 | 81 |
| 2024 February | 30 | 25 | 55 |
| 2024 January | 47 | 30 | 77 |
| 2023 December | 31 | 22 | 53 |
| 2023 November | 28 | 28 | 56 |
| 2023 October | 43 | 28 | 71 |
| 2023 September | 60 | 31 | 91 |
| 2023 August | 21 | 14 | 35 |
| 2023 July | 24 | 25 | 49 |
| 2023 June | 33 | 24 | 57 |
| 2023 May | 40 | 19 | 59 |
| 2023 April | 18 | 12 | 30 |
| 2023 March | 78 | 26 | 104 |
| 2023 February | 47 | 24 | 71 |
| 2023 January | 29 | 23 | 52 |
| 2022 December | 84 | 21 | 105 |
| 2022 November | 54 | 35 | 89 |
| 2022 October | 52 | 33 | 85 |
| 2022 September | 33 | 28 | 61 |
| 2022 August | 53 | 39 | 92 |
| 2022 July | 75 | 27 | 102 |
| 2022 June | 98 | 29 | 127 |
| 2022 May | 76 | 40 | 116 |
| 2022 April | 75 | 49 | 124 |
| 2022 March | 55 | 56 | 111 |
| 2022 February | 50 | 32 | 82 |
| 2022 January | 58 | 30 | 88 |
| 2021 December | 32 | 47 | 79 |
| 2021 November | 30 | 43 | 73 |
| 2021 October | 48 | 50 | 98 |
| 2021 September | 27 | 52 | 79 |
| 2021 August | 25 | 36 | 61 |
| 2021 July | 23 | 34 | 57 |
| 2021 June | 18 | 31 | 49 |
| 2021 May | 51 | 45 | 96 |
| 2021 April | 66 | 74 | 140 |
| 2021 March | 53 | 26 | 79 |
| 2021 February | 38 | 25 | 63 |
| 2021 January | 22 | 13 | 35 |
| 2020 December | 35 | 8 | 43 |
| 2020 November | 26 | 30 | 56 |
| 2020 October | 21 | 23 | 44 |
| 2020 September | 39 | 23 | 62 |
| 2020 August | 26 | 14 | 40 |
| 2020 July | 21 | 15 | 36 |
| 2020 June | 35 | 21 | 56 |
| 2020 May | 17 | 16 | 33 |
| 2020 April | 21 | 10 | 31 |
| 2020 March | 14 | 8 | 22 |
| 2020 February | 2 | 0 | 2 |
| 2018 October | 0 | 1 | 1 |
| 2018 April | 1 | 1 | 2 |
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