Abstract Objectives In this article, we describe how to include considerations about resource utilization when making recommendations according to the Grading of Recommendations Assessment, ...Development, and Evaluation (GRADE) approach. Study Design and Settings We focus on challenges with rating the confidence in effect estimates (quality of evidence) and incorporating resource use into evidence profiles and Summary of Findings (SoF) tables. Results GRADE recommends that important differences in resource use between alternative management strategies should be included along with other important outcomes in the evidence profile and SoF table. Key steps in considering resources in making recommendations with GRADE are the identification of items of resource use that may differ between alternative management strategies and that are potentially important to decision makers, finding evidence for the differences in resource use, making judgments regarding confidence in effect estimates using the same criteria used for health outcomes, and valuing the resource use in terms of costs for the specific setting for which recommendations are being made. Conclusions With our framework, decision makers will have access to concise summaries of recommendations, including ratings of the quality of economic evidence, and better understand the implications for clinical decision making.
Based on a critical synthesis of literature on use of the Promoting Action on Research Implementation in Health Services (PARIHS) framework, revisions and a companion Guide were developed by a group ...of researchers independent of the original PARIHS team. The purpose of the Guide is to enhance and optimize efforts of researchers using PARIHS in implementation trials and evaluations.
Authors used a planned, structured process to organize and synthesize critiques, discussions, and potential recommendations for refinements of the PARIHS framework arising from a systematic review. Using a templated form, each author independently recorded key components for each reviewed paper; that is, study definitions, perceived strengths/limitations of PARIHS, other observations regarding key issues and recommendations regarding needed refinements. After reaching consensus on these key components, the authors summarized the information and developed the Guide.
A number of revisions, perceived as consistent with the PARIHS framework's general nature and intent, are proposed. The related Guide is composed of a set of reference tools, provided in Additional files. Its core content is built upon the basic elements of PARIHS and current implementation science.
We invite researchers using PARIHS for targeted evidence-based practice (EBP) implementations with a strong task-orientation to use this Guide as a companion and to apply the revised framework prospectively and comprehensively. Researchers also are encouraged to evaluate its use relative to perceived strengths and issues. Such evaluations and critical reflections regarding PARIHS and our Guide could thereby promote the framework's continued evolution.
Abstract Direct evidence comes from research that directly compares the interventions in which we are interested when applied to the populations in which we are interested and measures outcomes ...important to patients. Evidence can be indirect in one of four ways. First, patients may differ from those of interest (the term applicability is often used for this form of indirectness). Secondly, the intervention tested may differ from the intervention of interest. Decisions regarding indirectness of patients and interventions depend on an understanding of whether biological or social factors are sufficiently different that one might expect substantial differences in the magnitude of effect. Thirdly, outcomes may differ from those of primary interest—for instance, surrogate outcomes that are not themselves important, but measured in the presumption that changes in the surrogate reflect changes in an outcome important to patients. A fourth type of indirectness, conceptually different from the first three, occurs when clinicians must choose between interventions that have not been tested in head-to-head comparisons. Making comparisons between treatments under these circumstances requires specific statistical methods and will be rated down in quality one or two levels depending on the extent of differences between the patient populations, co-interventions, measurements of the outcome, and the methods of the trials of the candidate interventions.
Abstract In the GRADE approach, randomized trials start as high-quality evidence and observational studies as low-quality evidence, but both can be rated down if a body of evidence is associated with ...a high risk of publication bias. Even when individual studies included in best-evidence summaries have a low risk of bias, publication bias can result in substantial overestimates of effect. Authors should suspect publication bias when available evidence comes from a number of small studies, most of which have been commercially funded. A number of approaches based on examination of the pattern of data are available to help assess publication bias. The most popular of these is the funnel plot; all, however, have substantial limitations. Publication bias is likely frequent, and caution in the face of early results, particularly with small sample size and number of events, is warranted.
Brecht's play on the life of Galileo serves as a motto for the author's analysis of the relevant existing intersections between Law and Science(s). Bearing in mind the growing impact in trials of the ...so-called scientific evidence, the paper aims to inquire what concept of science prevails among lawyers. Moreover, it seems paramount to understand how this concept of science contributes--to what extent and limitations--to the judicial fact-finding. To seek the answers needed, the author draws a comparative analysis of the legal practice in common law jurisdictions, i.e. the North American, and in European civil law countries such as Portugal. As one can conclude from the reading of Brechts's play on the trial of Galileo, the use of science and the contributions of men of science in judicial proceedings today is not without concessions, compromises, or sacrifices.
Esta investigación se aproxima al estudio comparado de la historia del derecho mirando aspectos de la vida y obra de John H. Wigmore. Se ofrece, primero, una definición del estudio comparado de la ...historia del derecho. En segundo lugar, se aborda un mosaico de inquietudes que Wigmore experimentó y vivió. Se explora allí un diálogo troncal del referido jurista con el derecho relativo a la prueba (evidence), un diálogo auxiliar con otras disciplinas y un hilo conductor que se presenta en su interés por la historia del derecho y el derecho comparado. Se advierte entonces sobre el papel que distintos actores pueden tener en el desarrollo de una disciplina autónoma, al tiempo que interactúan con otros actores en diversas jurisdicciones.
O presente estudo versa sobre a prova do pagamento, bem como a natureza e forma da quitação, correlacionando os institutos que, apesar de logicamente ligados, não se confundem. Investiga-se os modos ...de comprovação do adimplemento, explorando o conceito e as formas de quitação, bem como os efeitos decorrentes da mesma, cotejando, ainda, com o uso da prova testemunhal. É analisada a possibilidade e limitação do uso da prova testemunhal para comprovação do adimplemento, ao longo da história do processo civil brasileiro e, especialmente, ante o Código de Processo Civil de 2015, averiguando-se a existência de prescrição de prova documental para a demonstração do cumprimento da prestação contratual. O estudo combina, assim, análises diacrônica e sincrônica, explorando os meios prova do pagamento ao longo do tempo e aferindo sua atual previsão legal, aceitação doutrinária e aplicação jurisprudencial. Por fim, concluiu-se pela distinção entre prova do pagamento e quitação, resultando a pesquisa na constatação de que, apesar da conveniência e expectativa de que haja prova documental a comprovar o adimplemento, o sistema jurídico não exige que somente por tal via seja demonstrada a entrega da prestação contratual devida, podendo, para tanto, em alguns casos, ser suficiente a prova testemunhal.
Clear communication of systematic review findings will help readers and decision makers. We built on previous work to develop an approach that improves the clarity of statements to convey findings ...and that draws on Grading of Recommendations Assessment, Development and Evaluation (GRADE).
We conducted workshops including 80 attendants and a survey of 110 producers and users of systematic reviews. We calculated acceptability of statements and revised the wording of those that were unacceptable to ≥40% of participants.
Most participants agreed statements should be based on size of effect and certainty of evidence. Statements for low, moderate and high certainty evidence were acceptable to >60%. Key guidance, for example, includes statements for high, moderate and low certainty for a large effect on intervention x as: x results in a large reduction…; x likely results in a large reduction…; x may result in a large reduction…, respectively.
Producers and users of systematic reviews found statements to communicate findings combining size and certainty of an effect acceptable. This article provides GRADE guidance and a wording template to formulate statements in systematic reviews and other decision tools.
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