Submitted by Fabiana Gonçalves Pinto (benf@ndc.uff.br) on 2015-12-07T14:06:03Z No. of bitstreams: 1 Luciana Miranda Rodrigues.pdf: 2906831 bytes, checksum: c63fff07e6a85a3c8689b9aadbab96a2 (MD5) / Made available in DSpace on 2015-12-07T14:06:03Z (GMT). No. of bitstreams: 1 Luciana Miranda Rodrigues.pdf: 2906831 bytes, checksum: c63fff07e6a85a3c8689b9aadbab96a2 (MD5) Previous issue date: 2010 / Mestrado Acadêmico em Ciências do Cuidado em Saúde / Este estudo teve como objetivos avaliar a efetividade do hidrogel 2% em pacientes com úlceras de perna; estimar o custo médio do uso do hidrogel 2% num período de 90 dias e comparar o custo do uso do hidrogel 2% em pacientes com úlceras de perna com hidrogéis industrializados disponíveis no mercado nacional. Trata-se de um estudo de intervenção terapêutica, prospectivo, do tipo ensaio clínico não controlado sobre a avaliação do uso do hidrogel 2% produzido na farmácia universitária para o tratamento de feridas em pacientes com úlceras de perna. A amostra constou de 20 voluntários, de ambos os sexos, para 90 dias de tratamento com o hidrogel a 2%, totalizando 250 consultas durante o período de fevereiro a outubro de 2010. Este estudo foi encaminhado ao Comitê de Ética em Pesquisa do Hospital Universitário Antônio Pedro sob o parecer CAAE n0 0154.0.258.000-08 e os termos de consentimento livre e esclarecido e de fotografia encontram-se de acordo com as Resoluções n0 196/96 e 251/97 do Conselho Nacional de Saúde. Do grupo amostral, pôde-se identificar que 62,5% dos voluntários eram predominantemente do sexo feminino. A idade média variou de 60,5 anos ± 11,4 e que 52,25% residiam no município de Niterói. Em relação à análise da evolução clínica das úlceras de perna, pôde-se observar que surgiram dois grupos distintos com relação ao tamanho da área da lesão, sendo estas classificadas no estudo como, área 1 – para lesões com tamanho acima de 100 cm 2 e área 2 – para lesões com tamanho abaixo de 100 cm 2. O tecido de maior prevalência na avaliação inicial foi o tecido de esfacelo que apresentou uma média de 3,75 ± 1,2 de presença no leito da lesão dos voluntários do estudo. Destaca-se ainda, que após 90 dias de tratamento com o hidrogel a 2%, foram observadas alterações teciduais importantes para a cicatrização e/ou redução da área lesional (p=0,0416). A presença do tecido de granulação passa a prevalecer com uma média de 3,12 ± 1,0 e 25% dos voluntários obtiveram cicatrização total (100% de tecido de epitelização). Em relação à análise dos custos do tratamento com o hidrogel a 2% destacou-se inicialmente que o tratamento das úlceras pertencentes à área 1 foi maior que a das úlceras da área 2, sendo esta variação de R$114,40 a R$393,23 (M= R$227,55 e Dp=72). Ao comparar o tratamento das úlceras de perna com hidrogel 2% 100 gramas com outros hidrogéis disponíveis no mercado nos valores proporcionais a 100 gramas observou-se uma diferença significativa (p= 0,0003) para os valores referentes às áreas 1 e 2 em todas as perspectivas estudadas. Os valores variaram de acordo com o tamanho das áreas da lesão. A área 1 teve uma variação de preço de R$ 112,85 a R$ 912,11 nas três esferas estudas e a área 2 variou de R$ 70,75 a R$ 558,88 nas três perspectivas do estudo. Ao analisar os custos e a efetividade do uso dessa terapêutica, verificou-se que o hidrogel a 2% apresenta uma efetividade significante assim como os seus custos, não sendo justificável a sua não utilização nos serviços de saúde. O hidrogel a 2% manipulado magistralmente numa farmácia universitária representa uma alternativa para essa situação, uma vez que promove melhora das taxas de cicatrização, com diminuição do tempo de tratamento dessas úlceras, além de ser um tratamento de baixo custo, se comparado a outros hidrogéis industrializados disponíveis no mercado nacional, trazendo menores gastos para os serviços de saúde e órgãos de financiamento. / This study aimed to evaluate the effectiveness of hydrogel 2% in patients with leg ulcers, estimate the average cost of using the hydrogel 2% within 90 days and compare the cost of the use of hydrogel 2% with others hydrogels industrialized. This is a study of therapeutic intervention, prospective clinical trial, uncontrolled on evaluating use of hydrogel 2% produced in the pharmacy college in the treatment of wounds in patients with leg ulcers. The sample consisted of 20 volunteers of both sexes, during 90 days of treatment with the hydrogel to 2% to 250 consultations during the period from February to October 2010. This study was submitted to Committee on Research Ethics at University Hospital on advice CAAE number 0154.0.258.000-08 and terms of consent and photography are in accordance with Resolutions 196/96 and 251/97 of the National Health Council. Of this sample group, could be identified that 62.5% of the volunteers were predominantly female. The mean age ranged from 11.4 ± 60.5 years and 52.25% lived in Niterói. On the analysis of clinical outcome of leg ulcers, it was observed that emerged two distinct groups with respect to the size of the lesion area, which are classified in this study: area1 - for lesions with a size greater than 100 cm2 and area 2 - for lesions with size below 100 cm2. About these group it was noted that the tissue with the highest prevalence at baseline was the desvitalization tissue that showed presence an average 3.75 ± 1.2 of the wound bed. After 90 days by treatment with hydrogel 2%, it has obtained tissue with an important changes to healing and / or reduction area lesion (p = 0.0416). The granulation tissue presence begins to prevail with an average 3.12 ± 1.0 and 25% these volunteers had total healing (100% epithelization tissue). On the costs analysis with hydrogel 2% treatment it has initially the ulcers belonging area 1 was higher than the second area of ulcers, and this variation was the R$ 114.40 to R$ 393, 23 (mean = R$ 227.55 and dv = 72). When comparing the treatment of leg ulcers with hydrogel 2% 100 grams with other commercially available hydrogels in proportionate amounts to 100 grams there was a significant difference (p = 0.0003) for the values related to areas 1 and 2 in all perspectives studied. The values ranged with the size of the lesion areas. The area 1 had a variation in price from R$ 112.85 to R$ 912.11 and the area 2 ranged from R$ 70.75 to R$ 558.88 on the three perspectives of the study. Analyzed the costs and effectiveness using this therapy, it was found that hydrogel 2% shows a significant efficacy as well as their costs are not justified in not using health services. The hydrogel 2% manipulated in a pharmacy college represents an alternative to this situation, since it promotes improved healing rates, decreased treatment time of these ulcers, as well as being a low-cost treatment, as compared to other hydrogels industrialized in the national sale, bringing lower costs to health services.

La thèse examine les configurations d'acteurs et d'organisations impliquées dans la régulation de l'accès au marché des médicaments en France et en Angleterre, en charge du contrôle scientifique et administratif de la fixation du prix et du remboursement de ces produits. Cette activité s'autonomise de l'appréciation clinique de leur qualité, de leur efficacité et de leur innocuité (dominant la régulation de leur approbation sur le marché) au cours des années 1980. / This thesis examines the configurations of actors and organizations involved in the regulation of the market access for drugs in France and England. Since the mid-1980s, this process has entailed the development of administrative and scientific controls over the fixing of the price and the conditions of reimbursement of these products. These controls have become autonomus from clinical appreciation of their quality, efficacity and safety that dominate approval regulation as a whole.

Contexte : La pression croissante sur les soins primaires nécessite de développer des approches adaptées pour apprécier la valeur des innovations dans ce domaine et identifier les conditions favorables à leur diffusion, ce qui peut s'avérer difficile, puisque ces innovations sont souvent complexes et de nature organisationnelle. Objectifs : Explorer les arguments de valeur de 10 innovations identifiées comme prometteuses lors des symposiums sur les innovations du Collège québécois des médecins de famille et proposer des pistes pour leur bonification et diffusion. Méthodes : Approche délibérative multidimensionnelle avec un panel diversifié de 12 cliniciens, gestionnaires, patients et citoyens. À partir de données synthétisées par dimension, chaque participant a apprécié le potentiel de valeur des innovations par un score et des arguments justificatifs pour chaque dimension individuellement et suite à une délibération. Le potentiel de valeur moyen a été calculé par innovation, les arguments ont fait l’objet d’une synthèse qualitative. Ces résultats ont informé une seconde délibération visant à identifier des pistes d’amélioration et diffusion qui ont été organisées par analyse thématique. Résultats : Les innovations d’adaptation de l'organisation des soins aux populations vulnérables ont été considérées comme ayant le plus grand potentiel de valeur dans l’ensemble. Les innovations visant l’optimisation des processus cliniques et d’amélioration continue ont reçu des appréciations plus variables. 460 pistes ont été classées en six catégories : objectifs, modalités d’accès, fonctionnement, impacts, gouvernance et contexte externe. Conclusions : L’exploration du potentiel de valeur d’innovations complexes avec une approche délibérative multidimensionnelle permet d’identifier, pour certaines catégories d’innovations en soins primaires, des arguments de valeur communs, et facilite l’identification de pistes d’amélioration et diffusion. / Context: The increasing pressure on primary care calls for the development of appropriate approaches to assess the value of innovations in this field and identify the conditions for their diffusion, which can be difficult, as these innovations are often complex and organizational in nature. Objectives: To explore the value arguments of 10 innovations identified as promising during the Quebec College of Family Physicians' Innovation Symposia and to propose avenues for their improvement and diffusion. Methods: Multidimensional deliberative approach with a diverse panel of 12 clinicians, managers, patients and citizens. Using data synthesized by dimension, each participant assessed the value potential of the innovations by providing a score and supporting arguments for each dimension individually, and following group deliberation. The average value potential was calculated per innovation, and the arguments were qualitatively synthesized. These results informed a second deliberation aimed at identifying avenues for improvement and deployment that were organized by thematic analysis. Results: Innovations aimed at adapting the organization of care for vulnerable populations were considered to have the greatest value potential overall, while interventions aimed at optimizing clinical processes and continuous improvement received more variable appraisals. 460 avenues were categorized into six areas: objectives, access modalities, operations, impacts, governance, and external context. Conclusions: Exploring the value potential of complex innovations with a multidimensional deliberative approach allowed the identification of common value arguments for certain categories of primary care innovations and facilitated the identification of pathways for their improvement and dissemination.

Digital health tools, platforms, and artificial intelligence– or machine learning–based clinical decision support systems are increasingly part of health delivery approaches, with an ever-greater degree of system interaction. Critical to the successful deployment of these tools is their functional integration into existing clinical routines and workflows. This depends on system interoperability and on intuitive and safe user interface design. The importance of minimizing emergent workflow stress through human factors research and purposeful design for integration cannot be overstated. Usability of tools in practice is as important as algorithm quality. Regulatory and health technology assessment frameworks recognize the importance of these factors to a certain extent, but their focus remains mainly on the individual product rather than on emergent system and workflow effects. The measurement of performance and user experience has so far been performed in ad hoc, nonstandardized ways by individual actors using their own evaluation approaches. We propose that a standard framework for system-level and holistic evaluation could be built into interacting digital systems to enable systematic and standardized system-wide, multiproduct, postmarket surveillance and technology assessment. Such a system could be made available to developers through regulatory or assessment bodies as an application programming interface and could be a requirement for digital tool certification, just as interoperability is. This would enable health systems and tool developers to collect system-level data directly from real device use cases, enabling the controlled and safe delivery of systematic quality assessment or improvement studies suitable for the complexity and interconnectedness of clinical workflows using developing digital health technologies.

Objectif principal: Il n’est pas démontré que les interventions visant à maîtriser voire modérer la médicamentation de patients atteints d’hypertension peuvent améliorer leur gestion de la maladie. Cette revue systématique propose d’évaluer les programmes de gestion contrôlée de la médicamentation pour l’hypertension, en s’appuyant sur la mesure de l’observance des traitements par les patients (CMGM). Design: Revue systématique. Sources de données: MEDLINE, EMBASE, CENTRAL, résumés de conférences internationales sur l’hypertension et bibliographies des articles pertinents. Méthodes: Des essais contrôlés randomisés (ECR) et des études observationnelles (EO) ont été évalués par 2 réviseurs indépendants. L’évaluation de la qualité (de ce matériel) a été réalisée avec l’aide de l’outil de Cochrane de mesure du risque de biais, et a été estimée selon une échelle à quatre niveaux de qualité Une synthèse narrative des données a été effectuée en raison de l'hétérogénéité importante des études. Résultats: 13 études (8 ECR, 5 EO) de 2150 patients hypertendus ont été prises en compte. Parmi elles, 5 études de CMGM avec l’utilisation de dispositifs électroniques comme seule intervention ont relevé une diminution de la tension artérielle (TA), qui pourrait cependant être expliquée par les biais de mesure. L’amélioration à court terme de la TA sous CMGM dans les interventions complexes a été révélée dans 4 études à qualité faible ou modérée. Dans 4 autres études sur les soins intégrés de qualité supérieure, il n'a pas été possible de distinguer l'impact de la composante CMGM, celle-ci pouvant être compromise par des traitements médicamenteux. L’ensemble des études semble par ailleurs montrer qu’un feed-back régulier au médecin traitant peut être un élément essentiel d’efficacité des traitements CMGM, et peut être facilement assuré par une infirmière ou un pharmacien, grâce à des outils de communication appropriés. Conclusions: Aucune preuve convaincante de l'efficacité des traitements CMGM comme technologie de la santé n’a été établie en raison de designs non-optimaux des études identifiées et des ualités méthodologiques insatisfaisantes de celles-ci. Les recherches futures devraient : suivre les normes de qualité approuvées et les recommandations cliniques actuelles pour le traitement de l'hypertension, inclure des groupes spécifiques de patients avec des problèmes d’attachement aux traitements, et considérer les résultats cliniques et économiques de l'organisation de soins ainsi que les observations rapportées par les patients. / Objective: Whether interventions including measurement and correction of patients’ attitude to antihypertensive medication can improve hypertension management is unclear. The review aims to determine the effectiveness of patient compliance measurement-guided medication management (CMGM) programs in essential hypertension. Design: Systematic review. Data sources: MEDLINE, EMBASE, CENTRAL, hypertension meetings abstracts, and bibliographies of identified articles. Methods: Randomized controlled trials (RCT) and observational studies (OS) were assessed by 2 reviewers independently. Quality assessment was performed with the Cochrane risk of bias tool and evaluated in a four-point continuum. A narrative data synthesis was performed due to significant heterogeneity among studies. Results: 13 studies (8 RCT, 5 OS) involving 2150 hypertensives were included. Five trials of CMGM with electronic devices as a sole intervention suggested decrease in blood pressure (BP) but the result may have been due to bias. Short-term BP improvement under CMGM in complex interventions was revealed in 4 studies of low-to-moderate quality. In 4 integrated care studies of higher quality the impact of CMGM component was not possible to distil and may be compromised by medication regimens. Regular feedback to the treating physician seems to be an essential component of CMGM and may be effectively mediated by a nurse or a pharmacist and via telecommunication. Conclusions: No convincing evidence for the effectiveness of CMGM as a health technology was found due to non-optimal study designs and methodological quality. Future research should follow accepted quality standards and current guidelines for the treatment of hypertension, include specific groups of patients with compliance problems and consider clinical, economic, patient-reported and organizational outcomes.

La littérature abordant les enjeux socio-éthiques et réglementaires associés aux médicaments est relativement abondante, ce qui n’est pas le cas des dispositifs médicaux (DM). Ce dernier secteur couvre une très large diversité de produits qui servent à de multiples applications: diagnostic, traitement, gestion des symptômes de certaines conditions physiques ou psychiatriques, restauration d’une fonction débilitante, chirurgie, etc. À tort, on a tendance à croire que les DM sont réglementés de la même manière que les médicaments, que ce soit pour les exigences concernant leur mise en marché ou des pratiques de surveillance après mise en marché. Or, au cours des dernières années, leur usage élargi, leur impact sur les coûts des soins de santé, et les rappels majeurs dont certains ont fait l’objet ont commencé à inquiéter la communauté médicale et de nombreux chercheurs. Ils interpellent les autorités réglementaires à exercer une plus grande vigilance tant au niveau de l’évaluation des nouveaux DM à risque élevé avant leur mise en marché, que dans les pratiques de surveillance après mise en marché. Une stratégie plus rigoureuse d’évaluation des nouveaux DM permettrait d’assurer un meilleur suivi des risques associés à leur utilisation, de saisir la portée des divers enjeux socio-éthiques découlant de l’utilisation de certains DM, et de préserver la confiance du public. D’emblée, il faut savoir que les autorités nationales n’ont pas pour mandat d’évaluer la portée des enjeux socio-éthiques, ou encore les coûts des DM qui font l’objet d’une demande de mise en marché. Cette évaluation est essentiellement basée sur une analyse des rapports risques-bénéfices générés par l’usage du DM pour une indication donnée. L’évaluation des impacts socio-éthiques et l’analyse coûts-bénéfices relèvent des agences d’Évaluation des technologies de santé (ÉTS). Notre recherche montre que les DM sont non seulement peu fréquemment évalués par les agences d’ÉTS, mais l’examen des enjeux socio-éthiques est trop souvent encore incomplet. En fait, les recommandations des rapports d’ÉTS sont surtout fondées sur une analyse coûts-bénéfices. Or, le secteur des DM à risque élevé est particulièrement problématique. Plusieurs sont non seulement porteurs de risques pour les patients, mais leur utilisation élargie comporte des impacts importants pour les systèmes de santé. Nous croyons que le Principisme, au cœur de l’éthique biomédicale, que ce soit au plan de l’éthique de la recherche que de l’éthique clinique, constitue un outil pour faciliter la reconnaissance et l’examen, particulièrement par les agences d’ÉTS, des enjeux socio-éthiques en jeu au niveau des DM à risque élevé. Également, le Principe de Précaution pourrait aussi servir d’outil, particulièrement au sein des agences nationales de réglementation, pour mieux cerner, reconnaître, analyser et gérer les risques associés à l’évaluation et l’utilisation de ce type de DM. Le Principisme et le Principe de Précaution pourraient servir de repères 1) pour définir les mesures nécessaires pour éliminer les lacunes observées dans pratiques associées aux processus de réglementation, et 2) pour mieux cerner et documenter les enjeux socio-éthiques spécifiques aux DM à risque élevé. / Socio-ethical and regulatory issues about drug development have received substantial coverage in the scientific literature over the years; this has not been the case of medical devices (MD). This latter sector comprises a vast array of products with a multitude of applications: diagnostics, treatment, symptom management for severe physical and psychiatric conditions, restoring physical functioning, surgery, etc. There is a mistaken view that MD are regulated in the same manner as pharmaceutical drugs, whether this be requirements regarding premarket assessment or post-market surveillance. Not only has the extensive use of MD in clinical practice and the resulting impact on healthcare expenditures raised concerns in the scientific and medical communities, but so too have the many recalls for high risk devices in recent years. Regulatory authorities have been challenged to exercise greater vigilance in both the premarket assessment and post-market surveillance of new high risk MD. A more rigorous evaluation strategy for new MD would permit better monitoring of the risks associated with their use, better understanding of the significance of the various socio-ethical issues arising from the use of MD, and thus preserve public confidence. From the outset, it should be noted that national authorities do not have a mandate to assess the significance of socio-ethical issues or the costs associated with the MD that are the subject of an application for marketing approval. This assessment is based primarily on risk-benefit analysis reports generated following the use of MD for a given indication. Evaluation of socioethical impact and cost-benefit analysis are the remit of Health Technology Assessment (HTA) agencies. But research shows that the MD are not only infrequently assessed by HTA agencies, but the consideration of socio-ethical issues is often incomplete; the recommendations of HTA reports are based mostly on a calculation of cost-benefit. However, the high risk MD sector is particularly problematic; many carry risks not only for patients, but their extended use has significant impact on healthcare systems. I argue that Principlism, associated to biomedical ethics, as much to research ethics and clinical ethics, could be adapted to facilitate the recognition and evaluation by HTA agencies of socio-ethical issues involved in high risk MD. The Precautionary Principle could also serve as a tool to help regulatory agencies to enforce understanding, recognition, analysis and management of the risks associated with the use of MD, especially high risk devices. Principlism and the Precautionary Principle could serve as benchmarks to 1) define necessary steps to eliminate gaps observed in the regulatory process, and 2) better understand and document the socio-ethical issues specific to high risk MD.

Health technology assessment: case study on breast carcinoma treatment in the Czech Republic Bc. Lenka Šlegerová January 4, 2019 Abstract This thesis proposes an original method for assessing total costs of med- ical treatment. It defines the semi-Markov model with four states that are associated with specific costs of the treatment, and not with patients' health statuses. This method is applied to individuals' treatment data drawn from the Czech clinical practice in the treatment of the metastatic HER2+ breast cancer. The aim is to assess the cost-effectiveness of adding medication per- tuzumab to the combination of trastuzumab+docetaxel within first-line therapy and to examine whether using individual data on Czech patients and the economic conditions leads to different results from foreign stud- ies. Furthermore, employing censored data from the clinical practice in the thesis complicates the estimation of patients' overall survival in compari- son to clinical-trials data that form random samples. Therefore, survival functions were not only estimated by the Kaplan-Meier estimator but also using the Cox proportional hazard model and the Accelerated failure time model that both control for the effects of included covariates. The addition of pertuzumab does not result in significantly longer pa- tients'...

Deux thématiques importantes des technologies de la santé: la pratique médicale fondée sur des preuves probantes et l’évaluation des interventions en médecine sont fondées sur une approche positiviste et une conception mécaniste des organisations en santé. Dans ce mémoire, nous soulevons l’hypothèse selon laquelle les théories de la complexité et la systémique permettent une conceptualisation différente de ces deux aspects de la gouvernance clinique d’une unité de Soins Intensifs Chirurgicaux (SIC), qui est considérée comme un système adaptatif dynamique non linéaire qui nécessite une approche systémique de la cognition. L’étude de cas d’une unité de SIC, permet de démontrer par de nombreux exemples et des analyses de micro-situations, toutes les caractéristiques de la complexité des patients critiques et instables et de la structure organisationnelle des SIC. Après une critique épistémologique de l’Evidence-Based Medicine nous proposons une pratique fondée sur des raisonnements cliniques alliant l’abduction, l’herméneutique et la systémique aux SIC. En nous inspirant des travaux de Karl Weick, nous suggérons aussi de repenser l’évaluation des modes d’interventions cliniques en s’inspirant de la notion d’organisation de haute fiabilité pour mettre en place les conditions nécessaires à l’amélioration des pratiques aux SIC. / In Health Technology Assessment and Management, Evidence-Based Medicine and many tools available for clinical assessment reflect a positivistic and mechanistic approach to Health Care Organizations and scientific knowledge. We argue that the Complexity Theories and the Systemic decision-making process give a different insight on those two aspects of Clinical Governance in a Surgical Intensive Care Unit (SICU). In a case-study, we describe the nature of critically ill and unstable patients and the organizational structure of a SICU in a university based hospital. We demonstrate all the characteristics of complexity in that setting, through the use of many examples and micro-situational analysis. After an epistemological critical appraisal of EBM, we suggest that if a SICU is conceptualized as a dynamic non-linear adaptative system, then clinical knowledge and scientific thought processes must include hermeneutical, systemic and abductive types of reasoning. Finally, we draw upon Karl Weick’s work and suggest that a SICU must be considered as a High Reliability Organization in order to aim for improving patient care and create better conditions for quality and performance in this complex environment.

Objectif principal: Il n’est pas démontré que les interventions visant à maîtriser voire modérer la médicamentation de patients atteints d’hypertension peuvent améliorer leur gestion de la maladie. Cette revue systématique propose d’évaluer les programmes de gestion contrôlée de la médicamentation pour l’hypertension, en s’appuyant sur la mesure de l’observance des traitements par les patients (CMGM). Design: Revue systématique. Sources de données: MEDLINE, EMBASE, CENTRAL, résumés de conférences internationales sur l’hypertension et bibliographies des articles pertinents. Méthodes: Des essais contrôlés randomisés (ECR) et des études observationnelles (EO) ont été évalués par 2 réviseurs indépendants. L’évaluation de la qualité (de ce matériel) a été réalisée avec l’aide de l’outil de Cochrane de mesure du risque de biais, et a été estimée selon une échelle à quatre niveaux de qualité Une synthèse narrative des données a été effectuée en raison de l'hétérogénéité importante des études. Résultats: 13 études (8 ECR, 5 EO) de 2150 patients hypertendus ont été prises en compte. Parmi elles, 5 études de CMGM avec l’utilisation de dispositifs électroniques comme seule intervention ont relevé une diminution de la tension artérielle (TA), qui pourrait cependant être expliquée par les biais de mesure. L’amélioration à court terme de la TA sous CMGM dans les interventions complexes a été révélée dans 4 études à qualité faible ou modérée. Dans 4 autres études sur les soins intégrés de qualité supérieure, il n'a pas été possible de distinguer l'impact de la composante CMGM, celle-ci pouvant être compromise par des traitements médicamenteux. L’ensemble des études semble par ailleurs montrer qu’un feed-back régulier au médecin traitant peut être un élément essentiel d’efficacité des traitements CMGM, et peut être facilement assuré par une infirmière ou un pharmacien, grâce à des outils de communication appropriés. Conclusions: Aucune preuve convaincante de l'efficacité des traitements CMGM comme technologie de la santé n’a été établie en raison de designs non-optimaux des études identifiées et des ualités méthodologiques insatisfaisantes de celles-ci. Les recherches futures devraient : suivre les normes de qualité approuvées et les recommandations cliniques actuelles pour le traitement de l'hypertension, inclure des groupes spécifiques de patients avec des problèmes d’attachement aux traitements, et considérer les résultats cliniques et économiques de l'organisation de soins ainsi que les observations rapportées par les patients. / Objective: Whether interventions including measurement and correction of patients’ attitude to antihypertensive medication can improve hypertension management is unclear. The review aims to determine the effectiveness of patient compliance measurement-guided medication management (CMGM) programs in essential hypertension. Design: Systematic review. Data sources: MEDLINE, EMBASE, CENTRAL, hypertension meetings abstracts, and bibliographies of identified articles. Methods: Randomized controlled trials (RCT) and observational studies (OS) were assessed by 2 reviewers independently. Quality assessment was performed with the Cochrane risk of bias tool and evaluated in a four-point continuum. A narrative data synthesis was performed due to significant heterogeneity among studies. Results: 13 studies (8 RCT, 5 OS) involving 2150 hypertensives were included. Five trials of CMGM with electronic devices as a sole intervention suggested decrease in blood pressure (BP) but the result may have been due to bias. Short-term BP improvement under CMGM in complex interventions was revealed in 4 studies of low-to-moderate quality. In 4 integrated care studies of higher quality the impact of CMGM component was not possible to distil and may be compromised by medication regimens. Regular feedback to the treating physician seems to be an essential component of CMGM and may be effectively mediated by a nurse or a pharmacist and via telecommunication. Conclusions: No convincing evidence for the effectiveness of CMGM as a health technology was found due to non-optimal study designs and methodological quality. Future research should follow accepted quality standards and current guidelines for the treatment of hypertension, include specific groups of patients with compliance problems and consider clinical, economic, patient-reported and organizational outcomes.

Submitted by Bruno Araujo Ramalho (brunrama@hotmail.com) on 2017-03-14T18:02:34Z No. of bitstreams: 1 Dissertação - BRUNO ARAUJO RAMALHO - (versão final).pdf: 2077332 bytes, checksum: 0dd8154f4be3890a0c30271468fdb13f (MD5) / Approved for entry into archive by Publicação Direito Rio (publicacao.direitorio@fgv.br) on 2017-03-15T18:39:56Z (GMT) No. of bitstreams: 1 Dissertação - BRUNO ARAUJO RAMALHO - (versão final).pdf: 2077332 bytes, checksum: 0dd8154f4be3890a0c30271468fdb13f (MD5) / Made available in DSpace on 2017-03-23T12:17:19Z (GMT). No. of bitstreams: 1 Dissertação - BRUNO ARAUJO RAMALHO - (versão final).pdf: 2077332 bytes, checksum: 0dd8154f4be3890a0c30271468fdb13f (MD5) Previous issue date: 2017-02-07 / Procedural requirements related to decision making and justification of regulatory choices may have limited application under uncertainty, informational limitation and other obstacles that lead the regulator to adopt strategies to tailor decision making to reality. Based on this hypothesis, and considering the uncertainties and issues of high technical complexity related to the 'list of health care procedures and events in health care', the objective of the research was to carry out an exploratory analysis intended to identify limitations, obstacles and observable strategies in the elaboration and justification of these norms. For this purpose, it was adopt a methodology of qualitative analysis based on documentary research, which included different documents available through the National Regulatory Agency for Private Health Insurance and Plans (ANS) website in public consultations, in the Technical Group for reviewing the list of procedures and in the Committee on Regulation of Health Care (COSAÚDE). As a result, it was verified the hypothesis mentioned above, since the dynamics of the choice presents restrictions that lead the regulator to adopt different strategies to deal with. The obstacles related to 'decision-making' dimension arise from the complexity and uncertainties related to the medical evidences, informational limitations and from interferences of the Legislative Branch and the Judiciary. Regarding the giving reasons requirement, although it is possible to see a greater density of justification starting in 2013, the reasons and replies presented in a synthesized format often do not suffice to clarify all the issues that support complex choices. Among the proposals of the study, the regulator should to provide a more detailed record about the valuation and the operationalization of its methodology criteria. / Exigências procedimentais relacionadas ao processo decisório e à justificação de escolhas regulatórias podem ter sua aplicação limitada em cenários de incerteza, limitação informacional e demais obstáculos que levam o regulador a adotar estratégias para adequar a tomada de decisão aos recursos disponíveis. Partindo-se desta hipótese, a pesquisa teve por objetivo a realização de uma análise exploratória com vistas a identificar limitações, obstáculos e estratégias observáveis na elaboração e justificação do rol de procedimentos e eventos em saúde – eis que a elaboração do 'rol' é permeada por incertezas e por questões de alta complexidade técnica. Para tanto, adotou-se a metodologia de análise qualitativa baseada em pesquisa documental, que englobou diferentes anexos disponibilizados a partir do sítio eletrônico da Agência Nacional de Saúde Suplementar (ANS) em consultas públicas, no Grupo Técnico de revisão do rol de procedimentos e no Comitê Permanente de Regulação da Atenção à Saúde (COSAÚDE). Ao final, foi possível evidenciar importantes elementos que moldam ou restringem a tomada de decisão e a sua respectiva justificação. No âmbito dos resultados, os obstáculos relacionados à dimensão 'processo decisório' decorrem de diferentes fontes de incerteza, do volume (e complexidade) das informações e de interferências promovidas pelo Poder Legislativo e Judiciário – sendo observáveis diferentes providências do regulador para cada caso. No que tange ao dever de motivação, embora se percebam melhorias a partir de 2013, a apresentação de justificativas e réplicas segue um formato mais compactado e não contempla algumas questões metodológicas que servem como base para premissas elencadas pelo regulador. Dentre outras propostas do estudo, sugeriu-se que a agência disponibilize o amplo acesso a documentos ou relatórios que registrem, de forma pormenorizada, a operacionalização dos quesitos que integram a metodologia de decisão.