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Informação sobre medicamentos antidiabéticos : contributo para o desenvolvimento de uma aplicação móvel para pessoas mais velhas com diabetes tipo 2
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Advisor(s)
Abstract(s)
Introdução: Está a ser testado um protótipo de uma aplicação para facilitar o autocuidado de pessoas mais velhas com diabetes tipo 2 (VASelfCare, Grant number LISBOA-01-0145-FEDER-024250, 02/SAICT/2016). O protótipo da aplicação visa a adesão à terapêutica e ao estilo de vida.
Doentes informados sobre os possíveis efeitos secundários e sobre a sua gestão, são aspetos importantes na adesão à terapêutica. Todos os medicamentos comercializados na EU devem de possuir de um folheto informativo (FI), que inclui uma lista de efeitos secundários. Esta informação é potencialmente usável no protótipo da aplicação.
Objetivo: Contribuir para o desenvolvimento de informação apropriada relativa aos efeitos secundários dos antidiabéticos para ser incorporada no protótipo VASelfCare.
Métodos: Foram retirados da base nacional de medicamentos e uso humano, os FI relativos aos antidiabéticos (exceto insulinas); foram selecionados os FI com data de aprovação mais recente para cada medicamento (ou combinação de dose fixa) e dose. A secção dos efeitos secundários foi extraída para uma base de dados. Posteriormente, critérios de inclusão e de exclusão foram definidos e aplicados e, os extratos de informação modificados foram categorizados em harmonizações, eliminações e adições. Por fim, foi efetuada uma revisão da literatura sobre estratégias efetivas de comunicação de risco.
Resultados: Foram analisados um total de 45 FI. A informação relativa aos efeitos secundários de cada medicamento, em média foi sujeita a 4.96 (DP = 2.98) harmonizações e 17.93 (DP =17.68) eliminações. A uniformização de termos técnicos em termos comuns de fatores de risco para o desenvolvimento efeitos secundários e de descritores de frequência são exemplos de harmonizações. Extratos de informação de efeitos secundários associados a testes laboratoriais e causados por combinações terapêuticas que não são de dose fixa, são exemplos de eliminações.
Efeitos secundários raros e graves que fazem parte das recomendações de minimização de risco foram mantidos (como a cetoacidose diabética causada pelos inibidores SGLT2). Em média, 2.09 (DP = 1.43) adições foram executadas aos efeitos secundários de cada medicamento, um exemplo comum é a explicação de sinais e sintomas das condições mencionadas no FI. No que concerne à revisão da literatura sobre comunicação de risco, foram analisados seis artigos; subsequentemente foram formuladas recomendações gerais de comunicação de risco e desenvolvidas representações visuais para os antidiabéticos.
Conclusão: No geral, a informação relativa aos efeitos secundários dos FI necessitou de
alterações substanciais para servir de base dos diálogos emitidos pela assistente virtual. Foram desenvolvidas estratégias, baseadas na evidência, para apresentar esta informação no protótipo da aplicação.
Background: An intelligent virtual assistant prototype to facilitate self-care in older people with type 2 diabetes is currently being tested (VASelfCare, Grant number LISBOA-01-0145-FEDER-024250, 02/SAICT/2016). The application prototype targets medication adherence and lifestyle. Effectively informing patients about medicines side-effects and their management is important in supporting medication adherence. All medicines marketed in the EU must have a package leaflet (PL), which includes a heading on possible side-effects. Such information seemed potentially usable in the application prototype. Aim: To contribute to the development of side-effect information on antidiabetic medicines appropriate for incorporation in the VASelfCare prototype. Methods: Firstly, a list of all antidiabetic medicines (except insulins) were retrieved from the national database on human medicines; the most recently approved PL was selected for each drug (or fixed-dose combination) and strength. Side-effect information in each PL was extracted to a database. Then, inclusion and exclusion criteria were applied and changes of information extracts (thematically-related textual data) were categorised into harmonisations, eliminations and additions. Secondly, a literature review on effective strategies for communicating risk was conducted. Results: A total of 45 PLs were analysed. On average, side-effect information of each medicine was subjected to 4.96 (SD = 2.98) harmonisations and 17.93 (SD = 17.68) eliminations. Replacing medical for plain terms plus the standardisation of information on risk factors for adverse reactions and frequency descriptors are examples of harmonisations. Information extracts on sideeffects associated with laboratory tests or caused by drug associations not presented in fixed-dose combinations are examples of eliminations. Information pertaining to side-effects rare or of unknown frequency was also eliminated. Rare but serious side-effect information that was part of risk minimisation recommendations was maintained (e.g. diabetic ketoacidosis caused by SGLT2 inhibitors). On average, 2.09 (SD = 1.43) additions were made to the side effect information of each medicine; a common example is explaining signs and symptoms of conditions mentioned in the PL. Concerning the literature review on risk communication, six papers were analysed; subsequently general recommendations for communicating risk were formulated and visual aids developed for antidiabetics. Conclusion: Overall, side-effect information from PLs of antidiabetic medicines requires substantial changes to serve as a basis to adequately counsel patients through a virtual assistant. Based on the literature strategies to present this information within the application prototype have been developed.
Background: An intelligent virtual assistant prototype to facilitate self-care in older people with type 2 diabetes is currently being tested (VASelfCare, Grant number LISBOA-01-0145-FEDER-024250, 02/SAICT/2016). The application prototype targets medication adherence and lifestyle. Effectively informing patients about medicines side-effects and their management is important in supporting medication adherence. All medicines marketed in the EU must have a package leaflet (PL), which includes a heading on possible side-effects. Such information seemed potentially usable in the application prototype. Aim: To contribute to the development of side-effect information on antidiabetic medicines appropriate for incorporation in the VASelfCare prototype. Methods: Firstly, a list of all antidiabetic medicines (except insulins) were retrieved from the national database on human medicines; the most recently approved PL was selected for each drug (or fixed-dose combination) and strength. Side-effect information in each PL was extracted to a database. Then, inclusion and exclusion criteria were applied and changes of information extracts (thematically-related textual data) were categorised into harmonisations, eliminations and additions. Secondly, a literature review on effective strategies for communicating risk was conducted. Results: A total of 45 PLs were analysed. On average, side-effect information of each medicine was subjected to 4.96 (SD = 2.98) harmonisations and 17.93 (SD = 17.68) eliminations. Replacing medical for plain terms plus the standardisation of information on risk factors for adverse reactions and frequency descriptors are examples of harmonisations. Information extracts on sideeffects associated with laboratory tests or caused by drug associations not presented in fixed-dose combinations are examples of eliminations. Information pertaining to side-effects rare or of unknown frequency was also eliminated. Rare but serious side-effect information that was part of risk minimisation recommendations was maintained (e.g. diabetic ketoacidosis caused by SGLT2 inhibitors). On average, 2.09 (SD = 1.43) additions were made to the side effect information of each medicine; a common example is explaining signs and symptoms of conditions mentioned in the PL. Concerning the literature review on risk communication, six papers were analysed; subsequently general recommendations for communicating risk were formulated and visual aids developed for antidiabetics. Conclusion: Overall, side-effect information from PLs of antidiabetic medicines requires substantial changes to serve as a basis to adequately counsel patients through a virtual assistant. Based on the literature strategies to present this information within the application prototype have been developed.
Description
Dissertação para obtenção do grau de Mestre no Instituto Universitário Egas Moniz
Keywords
Diabetes Efeitos secundários Folhetos informativos Estratégias de comunicação de risco