Cómo interpretar guías de práctica clínica elaboradas con metodología GRADE / Clinical guidelines using the GRADE system (Grading of Recommendations Assessment, Development and Evaluation)

The Ministry of Health of Chile, aiming to improve the quality of clinical practice guidelines, gradually incorporated the GRADE system (Grading of Recommendations, Assessment, Development and Evaluation) to develop evidence based recommendations. This system summarizes and evaluates the certainty of the available evidence. It moves from evidence to decision in a systematic and transparent manner, based on four main dimensions: balance between benefits and harms, certainty of evidence, patient's values and preferences and use of resources. The GRADE system produces strong and conditional recommendations. Strong recommendations provide confidence that the favorable consequences of an intervention clearly outweigh the adverse consequences, or vice versa. These recommendations apply to a broad range of patients and circumstances. Conditional recommendations, however, indicate that there is a close balance between favorable and unfavorable consequences of the intervention, there is uncertainty in the magnitude of benefits or adverse effects, there is uncertainty or variability in values and preferences of individuals or costs are not justified. These recommendations apply to many patients, but not all of them: ideally they should be discussed with each person. To achieve a better implementation of the recommendations made with GRADE methodology, health professionals should know the meaning of strong and conditional recommendations and they should be able to critically assess of them.

[Clinical guidelines using the GRADE system (Grading of Recommendations Assessment, Development and Evaluation)]. / Cómo interpretar guías de práctica clínica elaboradas con metodología GRADE.

The Ministry of Health of Chile, aiming to improve the quality of clinical practice guidelines, gradually incorporated the GRADE system (Grading of Recommendations, Assessment, Development and Evaluation) to develop evidence based recommendations. This system summarizes and evaluates the certainty of the available evidence. It moves from evidence to decision in a systematic and transparent manner, based on four main dimensions: balance between benefits and harms, certainty of evidence, patient's values and preferences and use of resources. The GRADE system produces strong and conditional recommendations. Strong recommendations provide confidence that the favorable consequences of an intervention clearly outweigh the adverse consequences, or vice versa. These recommendations apply to a broad range of patients and circumstances. Conditional recommendations, however, indicate that there is a close balance between favorable and unfavorable consequences of the intervention, there is uncertainty in the magnitude of benefits or adverse effects, there is uncertainty or variability in values and preferences of individuals or costs are not justified. These recommendations apply to many patients, but not all of them: ideally they should be discussed with each person. To achieve a better implementation of the recommendations made with GRADE methodology, health professionals should know the meaning of strong and conditional recommendations and they should be able to critically assess of them.

Evidence-based assessment of childhood injuries and physical risk-taking behaviors.

OBJECTIVE: To offer a critical evidence-based review and summary of assessment methods of childhood injuries and physical risk-taking behaviors. METHODS: A literature review was conducted to identify methodologies for assessing injury events and physical risk-taking behaviors. Methodologies reviewed included self- or parent-report scales, behavioral observations, and participant event monitoring. We classified methodologies according to published criteria of "well-established," "approaching well-established," or "promising." RESULTS: 7 methodologies were classified as "well-established", 9 were classified as "approaching well-established", and 8 were classified as "promising." CONCLUSIONS: Several approaches to assessing injuries or physical risk-taking behaviors have strong psychometric properties. Opportunities for further psychometric validation of techniques are noted. It is hoped that this review inspires researchers throughout the fields of pediatric and clinical child psychology to adopt assessments of injury and physical risk-taking in their ongoing research efforts.

Aggregating evidence about the positive and negative effects of treatments.

OBJECTIVES: Evidence-based decision making is becoming increasingly important in healthcare. Much valuable evidence is in the form of the results from clinical trials that compare the relative merits of treatments. In this paper, we present a new framework for representing and synthesizing knowledge from clinical trials involving multiple outcome indicators. METHOD: The framework generates and evaluates arguments for claiming that one treatment is superior, or equivalent, to another based on the available evidence. Evidence comes from randomized clinical trials, systematic reviews, meta-analyses, network analyses, etc. Preference criteria over arguments are used that are based on the outcome indicators, and the magnitude of those outcome indicators, in the evidence. Meta-arguments attacks arguments that are based on weaker evidence. RESULTS: We evaluated the framework with respect to the aggregation of evidence undertaken in three published clinical guidelines that involve 56 items of evidence and 16 treatments. For each of the three guidelines, the treatment we identified as being superior using our method is a recommended treatment in the corresponding guideline. CONCLUSIONS: The framework offers a formal approach to aggregating clinical evidence, taking into account subjective criteria such as preferences over outcome indicators. In the evaluation, the aggregations obtained showed a good correspondence with published clinical guidelines. Furthermore, preliminary computational studies indicate that the approach is viable for the size of evidence tables normally encountered in practice.

Evidence-based guidelines in the evaluation of work disability: an international survey and a comparison of quality of development.

BACKGROUND: In social insurance, the evaluation of work disability is becoming stricter as priority is given to the resumption of work, which calls for a guarantee of quality for these evaluations. Evidence-based guidelines have become a major instrument in the quality control of health care, and the quality of these guidelines' development can be assessed using the AGREE instrument. In social insurance medicine, such guidelines are relatively new. We were interested to know what guidelines have been developed to support the medical evaluation of work disability and the quality of these guidelines. METHODS: Five European countries that were reported to use guidelines were approached, using a recent inventory of evaluations of work disability in Europe. We focused on guidelines that are disease-oriented and formally prescribed in social insurance medicine. Using the AGREE instrument, these guidelines were appraised by two researchers. We asked two experts involved in guideline development to indicate if they agreed with our results and to provide explanations for insufficient scores. RESULTS: We found six German and sixteen Dutch sets of disease-oriented guidelines in official use. The AGREE instrument was applicable, requiring minor adaptations. The appraisers reached consensus on all items. Each guideline scored well on 'scope and purpose' and 'clarity and presentation'. The guidelines scored moderately on 'stakeholder involvement' in the Netherlands, but insufficiently in Germany, due mainly to the limited involvement of patients' representatives in this country. All guidelines had low scores on 'rigour of development', which was due partly to a lack of documentation and of existing evidence. 'Editorial independence' and 'applicability' had low scores in both countries as a result of how the production was organised. CONCLUSION: Disease-oriented guidelines in social insurance medicine for the evaluation of work disability are a recent phenomenon, so far restricted to Germany and the Netherlands. The AGREE instrument is suitably applicable to assess the quality of guideline development in social insurance medicine, but some of the scoring rules need to be adapted to the context of social insurance. Existing guidelines do not meet the AGREE criteria to a sufficient level. The way patients' representatives can be involved needs further discussion. The guidelines would profit from more specific recommendations and, for providing evidence, more research is needed on the functional capacity of people with disabilities.

[Assessment of clinical trial quality and its impact on meta-analyses]. / Avaliação da qualidade de estudos clínicos e seu impacto nas metanálises.

OBJECTIVE: To evaluate whether different quality assessment tools applied to a group of clinical trials could be correlated, and what would be their impact on meta-analysis results. METHODS: Thirty-eight randomized controlled clinical trials were analyzed. These had been selected for a systematic review of the therapeutic efficacy of alpha interferon for treating chronic hepatitis B. The following tools were utilized: Maastricht (M), Delphi (D), Jadad (J) and the Cochrane Collaboration (CC) method (gold standard). The Spearman correlation coefficient was used to compare the results from the three methods. The Kappa test was used to assess the concordance between the reviewers in applying the tools, and the weighted Kappa test was applied to compare the quality ranking determined by the tools. The outcomes assessed in the meta-analyses were clearance of HBV-DNA and HBeAg. RESULTS: The studies presented regular to low quality. The concordance between reviewers varied according to the instrument utilized: D=0.12; J=0.29; M=0.33; and CC=0.53. The correlation was moderate and homogeneous (D/J=0.51; D/M=0.53; and J/M=0.52). The meta-analysis result relating to HBV-DNA ranged from RR=0.71 (95% CI: 0.66-0.77) to RR=0.67 (95% CI: 0.58-0.79). For HBeAg, the results ranged from RR=0.85 (95% CI: 0.80-0.90) to RR=0.85 ( 95% CI: 0.77-0.93). These results depended on the quality of the studies included. CONCLUSIONS: The quality assessment tools presented good correlation. In systematic reviews with the same direction of effect, the quality assessment may not significantly change the results. The Cochrane Collaboration method was the most reproducible method and easiest to apply.