Background and objectives: Incorporating patient values and preferences as an essential input for decision-making has its potential merits in respecting the autonomy of patients, improving adherence and clinical outcomes. The Grading of Recommendations Assessment, Development and Evaluation (short GRADE) working group conceptualizes patient values and preferences as “the relative importance patient place on the main outcomes”. The objectives of this thesis include: 1) to provide an overview of a process for systematically incorporating values and preferences in guideline development; 2) to conduct a systematic review on outcome importance studies, using chronic obstructive pulmonary disease (COPD) as an example; 3) to provide guidance on how to assess certainty of evidence describing outcome importance using the GRADE criteria. Methods: We performed systematic reviews, asked clinical experts to provide feedback according to their clinical experience, and consulted patient representatives to obtain information about relative importance of outcomes in a new national guideline program. We conducted a systematic review to summarize the COPD related relative importance of outcome studies. We used a multi-pronged approach to develop the guidance for assessing certainty of evidence about relative importance of outcome and values and preferences. We applied the developed GRADE approach to relative importance of outcome systematic review examples and consulted the stakeholders in the GRADE working group for feedback. Results and conclusion: We provided an empirical strategy to find and incorporate values and preferences in guidelines by performing systematic reviews and eliciting information from guideline panel members and patient representatives. However, we identified the need for researches on how to assess the certainty of this evidence, and best summarize and present the findings. In our comprehensive systematic review project on COPD patient values and preferences we demonstrated the utility of rating evidence in systematic reviews of outcome importance. We describe the rationale for considering GRADE domains for the evidence about the importance of outcomes. We propose the assessment of the body of evidence starts at “high certainty”, and rate down for serious problems in GRADE domains including risk of bias, indirectness, inconsistency, imprecision and publication bias. Specific to risk of bias domain, we propose a preliminary consideration for risk of bias. The sources of indirectness for relative importance of outcome evidence include indirectness from PICO (population, intervention, comparison, and outcome) elements, and methodological indirectness. As meta-analyses are uncommon when summarizing the evidence about relative importance of outcome, inconsistency and imprecision assessments are challenging. Inconsistency arises from PICO and methodological elements that should be explored. The width of the confidence interval and sample size should inform judgments about imprecision. We also provide suggestions on how to detect publication bias based on empirical information. Finally, we also discuss the applicability of domains to rate up the certainty. We develop the GRADE approach for rating risk of bias, indirectness, inconsistency, imprecision and other domains when evaluating a body of evidence describing the relative importance of outcomes. Our examples should guide users and provide a basis for discussion and further development of the GRADE system. / Thesis / Doctor of Philosophy (PhD)

Thesis (Ph. D.)--University of New South Wales, 2004. / Also available online.

Clinical practice, public health, and policy guidelines should be developed based on a systematic approach that uses the best available evidence. The advent of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework has facilitated this, resulting in a transparent approach to guideline development. GRADE suggests that guideline developers seldom make strong recommendations based on low or very low confidence in effect estimates (strong l/vl). The World Health Organization (WHO) produces recommendations that guide public health policy and, in 2003, WHO adopted the GRADE approach to guideline development. Initial anecdotal evidence suggested that WHO issues a large number of strong recommendations and particularly strong l/vl. Our research team evaluated the nature of WHO recommendations and conducted a qualitative study using interviews of guideline panel members. Key findings included: i) WHO makes a large proportion of recommendations as strong l/vl ii) many strong l/vl are inconsistent with GRADE guidance iii) reasons guideline panel members offered for strong l/vl included skepticism about the value of making conditional recommendations; political considerations; a high confidence in benefits despite formal ratings of low confidence; and long-standing practices, funding, and policy; iv) methodologist interviewees indicated panelists’ lack of commitment to conditional recommendations; a perceived tension between methodologists and panelists due to resistance to adhering to GRADE guidance; both financial and non-financial conflicts of interest among panel members as explanations of strong l/vl; and the need for greater clarity of, and support for, the role of methodologists as co-chairs of panels. The understanding of when and why strong l/vl are formulated at WHO is an important methodological issue that has implications not just for WHO, but for a wide range of guideline developers elsewhere. Our findings offer insights that may guide interventions to enhance trustworthiness of practice guidelines. / Thesis / Doctor of Philosophy (PhD)

Eine evidenzbasierte Gestaltung von Studium und Lehre, wie sie heute normativ eingefordert wird, bedarf des integrierten Zusammenwirkens von Qualitätsmanagement und Hochschuldidaktik – aber gibt es dieses in der Praxis? Mit Blick auf die allgemeine Befundlage, aber auch anhand einer eigenen empirischen Untersuchung zeigt der Beitrag diesbezüglich auf, dass Qualitätsmanagement und Hochschuldidaktik als weitgehend desintegrierte Funktionsbereiche wahrgenommen werden und Evidenzbasierung in der Praxis folglich keinen sehr hohen Stellenwert genießt. Ausgehend von einer Ursachenanalyse wird auf die dysfunktionalen, aber auch auf die funktionalen Auswirkungen dieser Separierung aufmerksam gemacht.

This thesis examines philosophical controversies surrounding the evaluation of medical treatments, with a focus on the evidential roles of randomised trials and mechanisms in Evidence-Based Medicine. Current 'best practice' usually involves excluding non-randomised trial evidence from systematic reviews in cases where randomised trials are available for inclusion in the reviews. The first paper challenges this practice and evaluates whether adding of evidence from non-randomised trials might improve the quality and precision of some systematic reviews. The second paper compares the alleged methodological benefits of randomised trials over observational studies for investigating treatment benefits. It suggests that claims about the superiority of well-conducted randomised controlled trials over well-conducted observational studies are justified, especially when results from the two methods are contradictory. The third paper argues that postulating the unpredictability paradox in systematic reviews when no detectable empirical differences can be found requires further justification. The fourth paper examines the problem of absence causation in the context of explaining causal mechanisms and argues that a recent solution (Barros 2013) is incomplete and requires further justification. Solving the problem by describing absences as causes of 'mechanism failure' fails to take into account the effects of absences that lead to vacillating levels of mechanism functionality (i.e. differences in effectiveness or efficiency). The fifth paper criticises literature that has emphasised functioning versus 'broken' or 'non-functioning' mechanisms emphasising that many diseases result from increased or decreased mechanism function, rather than complete loss of function. Mechanistic explanations must account for differences in the effectiveness of performed functions, yet current philosophical mechanistic explanations do not achieve this. The last paper argues that the standard of evidence embodied in the ICE theory of technological function (i.e. testimonial evidence and evidence of mechanisms) is too permissive for evaluating whether the proposed functions of medical technologies have been adequately assessed and correctly ascribed. It argues that high-quality evidence from clinical studies is necessary to justify functional ascriptions to health care technologies. / <p>QC 20150312</p>

Submitted by girlei veloso marinho marinho (gvmarinho1000@hotmail.com) on 2012-01-12T21:59:24Z No. of bitstreams: 1 RELATÓRIO COMPLETO DEFESA.pdf: 764614 bytes, checksum: 129de5bb31aa8be6865e936cec363340 (MD5) / Approved for entry into archive by ÁURA CORRÊA DA FONSECA CORRÊA DA FONSECA (aurea.fonseca@fgv.br) on 2012-01-13T17:13:00Z (GMT) No. of bitstreams: 1 RELATÓRIO COMPLETO DEFESA.pdf: 764614 bytes, checksum: 129de5bb31aa8be6865e936cec363340 (MD5) / Approved for entry into archive by Marcia Bacha (marcia.bacha@fgv.br) on 2012-01-17T12:54:12Z (GMT) No. of bitstreams: 1 RELATÓRIO COMPLETO DEFESA.pdf: 764614 bytes, checksum: 129de5bb31aa8be6865e936cec363340 (MD5) / Made available in DSpace on 2012-01-17T12:56:16Z (GMT). No. of bitstreams: 1 RELATÓRIO COMPLETO DEFESA.pdf: 764614 bytes, checksum: 129de5bb31aa8be6865e936cec363340 (MD5) Previous issue date: 2011-12-05 / The aim of this exploratory and applied study is justify the necessity of a program implantation known as chain of custody in the Criminal Laboratory Institute of Scientific and Technique Police of Rondônia’s State, in order to follow the changes that happened due to technological progress. Those changes cause the necessity of improve the quality of evidence in judicial process. The result obtained with the interviews show the lack of observation of professionals from organizations responsible to guarantee the authenticity and fitness of evidence in judicial. And what process due to the lack of a culture to a faithful compliance of chain of custody. Thereby, in this program can not miss a culture development related with chain of custody compliance because that is the element that has the power to transform and form consciences to the importance of a chain of custody to create an evidence with quality as well as show how to act in face of technological changes. / O objetivo deste estudo exploratório e aplicado é justificar a necessidade de implantação de um programa de cadeia de custódia no Instituto Laboratorial Criminal da Polícia Técnica e Científica do Estado de Rondônia a fim de se adequar às mudanças ocorridas no mundo contemporâneo estimuladas pelo avanço tecnológico. O resultado obtido com as entrevistas mostra a não percepção, por parte dos profissionais das organizações responsáveis pela autenticidade e idoneidade da prova pericial, das mudanças provocarem a necessidade de uma busca pela qualidade da prova pericial. E que ocorre em razão da falta de uma cultura para o fiel cumprimento da cadeia de custódia. Destarte, neste programa não pode faltar o desenvolvimento de uma cultura voltada para o cumprimento da cadeia de custódia, por esse ser o elemento que tem o poder de transformar e de formar consciências para a percepção da importância da cadeia de custódia na elaboração da prova pericial com qualidade, bem como mostrar como podemos agir diante desta inovação estimulada pelas mudanças do mundo contemporâneo.