>Magister Scientiae - MSc / In clinical trials, adherence of the participants to the dosing instructions is a major challenge. Many researchers have identified medication adherence as a topic to further explore in order to obtain good, usable and reproducible results. In order to gain an understanding of on-the-ground issues in clinical research a survey was conducted, isolating the issue of medication adherence among participants as a discussion point. The research was conducted specifically at clinical trial sites that are involved in HIV pre-exposure prophylaxis research. The survey was conducted at clinical trial sites across South Africa among health care workers in the clinical research sector. The principle issue to be identified was the perceptions of staff and researchers with regards to the current approach to adherence measurement and possible suggestions from them on future adherence interventions strategies. This research was conducted as a qualitative analysis from February to March 2014. Eighteen responses were received. Among the respondents were investigators, medical officers, nurses and pharmacists. The results of the survey suggest that healthcare workers have a strong understanding of the importance adherence monitoring and intervention. They have many ideas on which measurement tools work and which don’t, but most importantly feel that the self-report or interview techniques are the most useful. Researchers also feel that much more can be done in order to improve the perception of the clinical research institutes in the eyes of the community and that a more active role should be taken in the community in order to improve the acceptance of the participants to the use of the product.

Trata-se de um estudo descritivo transversal de abordagem quantitativa, realizado entre 75 portadores de hipertensão arterial (HA) seguidos no ambulatório de um hospital-escola de nível terciário, no interior paulista, realizado no período de setembro de 2008 a abril de 2009, tendo por objetivo avaliar a adesão ao tratamento. Para a coleta de dados foram utilizados três instrumentos: um relativo a dados sociodemográficos, da doença e do tratamento; o Teste de Morisky e Green (TMG) para avaliar a adesão ao tratamento medicamentoso e o Instrumento de Avaliar Atitudes Frente à Tomada de Remédios (IAAFTR). Os testes estatísticos foram realizados por meio do software Statistica 8.0, e os resultados foram considerados significativos quando o nível de significância foi (p <0,05). Os sujeitos possuíam idade média de 61,5 ±10,36 anos, 52,0% eram do sexo feminino, 85,3% brancos, 70,7% casados, 48,0% aposentados e 24,0% do lar, 65,3% possuíam ensino fundamental incompleto, média de 3,08 ±1,99 filho, 94,7% residiam com outros membros da família, 81,3% informaram renda familiar entre um e três salários mínimos; 48,0% apresentaram valores de pressão arterial (PA) maiores que 140X90mmHg, 48,0% eram obesos, 80,6% dos homens e 94,9% das mulheres apresentaram circunferência da cintura com valores alterados. A média do tempo de diagnóstico da hipertensão arterial sistêmica (HAS) foi de 15,57 ±9,61 anos. As principais comorbidades identificadas foram: diabetes mellitus (54,3%) e dislipidemia (46,6%). A média dos medicamentos utilizados foi de 5,1 comprimidos/dia, sendo os mais comumente utilizados os hipoglicemiantes (58,7%) e os antiagregantes plaquetários (54,8%). A média de medicamentos usados para o tratamento da HA foi de 3 comprimidos/dia, sendo que os diuréticos foram os mais usados (84,0%). Quando avaliados pelo TMG, 21 (28,0%) apresentaram adesão ao tratamento; pela utilização do IAAFTR 37 (49,3%) mostraram atitudes positivas frente à tomada dos medicamentos. Entre aqueles que apresentaram adesão pelo TMG, 16 (76,2%) também apresentaram atitudes positivas quando avaliados pelo IAAFTR. A prevalência de controle da PA foi maior para os que tiveram adesão (66,7%) e para aqueles com atitudes positivas (64,9%). Houve significância estatística para o sexo e atitude frente à tomada dos medicamentos em relação ao controle da PA. Os valores de PA foram menores para os que tiveram adesão pelo TMG e que apresentaram atitudes positivas quanto à tomada dos medicamentos (p <0,05). Em relação aos fatores de risco para a HAS, 64,0% não praticavam exercício físico; 9,3% eram fumantes; 17,3% faziam uso de bebida alcoólica e 54,7% diziam ser estressados; 96,0% citaram antecedentes familiares para doenças cardiovasculares. Diante deste contexto permanece um desafio quanto à necessidade de revisão das medidas educativas instituídas no sentido de possibilitar alternativas que possam melhorar, na prática, a adesão dos portadores de HA ao tratamento medicamentoso, o controle da PA e a mudança nos fatores de risco para a HAS. / It is a cross-section descriptive study of quantitative approach, carried out with 75 hypertensive outpatients of tertiary level, in upstate São Paulo, carried out from September 2008 to April 2009, aiming to evaluate adherence to the treatment. Three questionnaires were used to collect the data: one about socio-demographic data regarding the disease and the treatment; the Morisky-Green Test, to assess the adherence to the drug-based treatment and the Questionnaire to Evaluate Attitudes Towards Taking Medicines. The statistical tests were applied by means of the software Statistica 8.0, and the results were considered significant whenever the significance level was (p<0.05). The subjects average age was 61.5 ±10.36 years, 52.0% were women, 85.3% Caucasians, 70.7% married, 48.0% retired and 24.0% housewives, 65.3% did not finish primary education, they had on average 3.08 ±1.99 children, 94.7% lived with other family members, 81.3% stated that their familly income was between one and three minimum wages; 48.0% had blood pressure readings above 140X90 mmHg, 48.0% were overweight, 80.6% of the men and 94.9% of the women had unhealthily large waist circumferences. Average hypertension diagnosis time (HT) was 15.57 ±9.61 years. The most important comorbities identifed were: diabetes mellitus (54.3%) e dyslipidemia (46.6%). The average of the medications used was 5.1 pills/day, and the most commonly used drugs were hypoglycemiants (58.7%) and platelet antiaggregant (54.8%). The average of the medications used for the treatment of HT was 3 pills/day, and the diuretics were the most used ones (84.0%). When evaluated with the Morisky-Green test, 21 (28.0%) showed adherence to the treatment, by means of the Questionnaire to Evaluate Attitudes Towards Taking Medicines, 37 (49.3%) showed positive attitudes towards the taking the medicines. Those that showed adherence through the Morisky-Green test also showed positive attitudes when evaluated by means of the Questionnaire to Evaluate Attitudes Towards Taking Medicines. The prevalence of control of the blood pressure was higher for those who had adherence (66.7%) and for those with positive attitudes (64.9%). Gender and attitude towards taking medicines had statistical significance to the control of blood pressure. Blood pressure readings were lower in hypertensives that had adherence according to the Morisky- Green test and that had positive attitudes toward taking the medicines (p<0.05). Regarding the risk factors for HT, 64.0% did not practice physical exercise; 9.3% were smokers; 17.3% drank alcoholic drinks and 54.7% reported being stressed; 96% cited family antecedents of cardiovascular disease. In face of this context, there remains the challenge of reviewing the current educative measures to enable alternatives that may improve, in practice, the adherence of hypertensives to the drug-based treatment, the control of blood pressure and the change in the risk factors for HT.

This research presents a proposal for the assessment of technology to manage antiretroviral treatment. The system called Cell-Life has been successfully tested at a pilot site in Gugulethu, Cape Town from September 2002 till date and offers a cost-effective solution for adherence monitoring, side effect management, effective home based care and reducing pill count dependence at the clinic. With the aid of the Cell-Life SIM card menu (please see Appendix A, page 63) on a cell-phone the therapeutic counsellor is equipped with a live-link to the clinic or doctor while visiting patients. The menu allows entering data about the patient's drug adherence, side effects and symptoms, scheduling visits to the clinic and alert messages. The data is sent using short message service (SMS) and stored in a database, which can be accessed via the Internet by a doctor who will receive a complete report on the patient's status quo. The main benefits of the system lie in creating a communication link between the clinic/doctor and the therapeutic counsellor at minimal cost. Another benefit is the collection of reliable data relating to drug adherence and the minimising of human error through preset menu options on the phone. The pilot study has shown that management of anti-retroviral therapy is possible in resource-constraint urban settings. But for a provincial or national rollout of the Cell-Life system, the challenge is the lack of the required infrastructure, technology, personnel and logistics for effective operation of the Cell-Life systems specifically in the rural areas of South Africa. This research investigated the availability of the Cell-Life requirements in the Western Cape. The findings showed that the Cell-Life systems could be implemented in the health regions investigated across the Western Cape. It was also shown that an in depth needs assessment study is required before implementing the Cell-Life system in any community.

Fundamento y objetivo. Problemas de salud mental podrían afectar negativamente la adherencia al tratamiento farmacológico antihipertensivo (ATFA). El objetivo fue evaluar si existe asociación entre sintomatología depresiva (SD) y ATFA. Pacientes y métodos. Estudio transversal analítico en 424 pacientes con hipertensión arterial entre 40-59 años de clínica privada en Perú durante el año 2014. La variable de exposición (SD), se midió con el PHQ-9 y se categorizó en ausencia de síntomas depresivos (ASD), síntomas depresivos positivos (SDP) y otro síndrome depresivo y depresión mayor (OSDDM). La variable respuesta (ATFA) se definió según la escala de Morisky-Green. Se calcularon razones de prevalencia con intervalo de confianza al 95% [RP(IC95%)]. Resultados. La frecuencia de SDP fue 32, 5% y OSDDM fue 5,2%. El 54,3% fueron no adherentes. La proporción de no adherentes en pacientes con ASD, SDP y OSDDM fue 34,9%, 84,8% y 95,5%, respectivamente. El número de fármacos, el tiempo que toma actual medicamento, la frecuencia de toma de medicamentos, el presentar dislipidemia, y el uso de beta-bloqueadores y diuréticos se asoció con no ATFA a nivel bivariado (p<0,05). En los modelos de regresión, las personas con SDP [2,43(2,03-2,91)] y con OSDDM [2,74(2,27-3,31)] tuvieron una mayor probabilidad de ser no adherentes que aquellos con ASD, lo cual se mantuvo en los modelos ajustados. Conclusión. SD se asocia a no ser adherente al tratamiento antihipertensivo en pacientes en edad mediana. Se sugieren estudios longitudinales para evaluar causalidad. / Background and objective. Mental health problems could have an effect on the adherence to antihypertensive medication. The objective was to evaluate the association between the presence of depressive symptoms and adherence to antihypertensive medication. Patients and methods. A cross-sectional analytical study was carried out in 424 patients with hypertension with ages between 40-59 years attending a private-care clinic center in Peru during 2014. The exposure variable (depressive symptoms) was measured with PHQ- 9, which was categorized in the absence of depressive symptoms, positive depressive symptoms, and other depressive disorder and major depression. The response variable (adherence to antihypertensive medication), was defined according to Morisky-Green scale. Prevalence ratios with 95% confidence interval [OR (95% CI)] were calculated. Results. The frequency of positive depressive symptoms was 37.5%, and depressive disorder and major depression was 5.2%. 54.3% were non-adherent. The nonadherent proportion in patients with absence of depressive symptoms, positive depressive symptoms and depressive disorder or major depression was 34.9%, 84.8% and 95.5%, respectively (p <0.001). The number of drugs, the medication-taking frequency, the time on taking current medication, the presence of dyslipidemia, the use of beta-blockers and diuretics were associated with no adherence to antihypertensive medication, a bivariate level (p <0.05). In the regression models, people with positive depressive symptoms [2.43 (2.03 to 2.91)] and depressive disorder or major depression [2.74(2.27 to 3.31)] were more likely to be nonadherent than those with absence of depressive symptoms, which remained in the adjusted models. Conclusion. The depressive symptoms is associated with not being adherent to antihypertensive therapy in middle-aged patients. Longitudinal studies are suggested to evaluate causality. / Tesis

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Charles University, Faculty of Pharmacy in Hradec Králové Department of Social and Clinical Pharmacy Author: Eliška Voříšková Supervisor: PharmDr. Kateřina Malá, Ph.D. Consultant: Mgr. Barbora Košťálová Title of thesis: CONSENSUS OF CZECH TERMINOLOGY IN THE FIELD OF MEDICATION ADHERENCE BACKGROUND: The terminology of medication adherence has undergone a vast change over the last 50 years. As individual terms have not become established, they are often misused and interchanged between each other. The aim of this work was to analyze the Czech literature and to establish a consensus in the field of terminology of medication adherence using Delphi round survey. METHODS: For Czech language, a search of literature released before January 6th, 2021 in databases Solen, ProLékaře.cz, BMČ and PubMed was reviewed. There were 122 articles published between 1998-2020, themed on the medication adherence. Based on the review, a questionnaire for three-round Delphi survey was created as well as a list of panelists invited in the survey. The survey was online, anonymous and contained questions about translation of 7 terms and their definitions established by the English document so-called ABC Taxonomy. RESULTS: In the 1st round of the Delphi survey, 106 panelists were contacted, 46 of whom responded. A consensus on...

Indiana University-Purdue University Indianapolis (IUPUI) / Medication non-adherence is a major healthcare problem that negatively impacts the health and productivity of individuals and society as a whole. Reasons for medication non-adherence are multi-faced, with no clear-cut solution. Adherence to medication remains a difficult area to study, due to inconsistencies in representing medicationadherence behavior data that poses a challenge to humans and today’s computer technology related to interpreting and synthesizing such complex information. Developing a consistent conceptual framework to medication adherence is needed to facilitate domain understanding, sharing, and communicating, as well as enabling researchers to formally compare the findings of studies in systematic reviews. The goal of this research is to create a common language that bridges human and computer technology by developing a controlled structured vocabulary of medication adherence behavior—“Medication Adherence Behavior Ontology” (MAB-Ontology) using breast cancer as a case study to inform and evaluate the proposed ontology and demonstrating its application to real-world situation. The intention is for MAB-Ontology to be developed against the background of a philosophical analysis of terms, such as belief, and desire to be human, computer-understandable, and interoperable with other systems that support scientific research. The design process for MAB-Ontology carried out using the METHONTOLOGY method incorporated with the Basic Formal Ontology (BFO) principles of best practice. This approach introduces a novel knowledge acquisition step that guides capturing medication-adherence-related data from different knowledge sources, including adherence assessment, adherence determinants, adherence theories, adherence taxonomies, and tacit knowledge source types. These sources were analyzed using a systematic approach that involved some questions applied to all source types to guide data extraction and inform domain conceptualization. A set of intermediate representations involving tables and graphs was used to allow for domain evaluation before implementation. The resulting ontology included 629 classes, 529 individuals, 51 object property, and 2 data property. The intermediate representation was formalized into OWL using Protégé. The MAB-Ontology was evaluated through competency questions, use-case scenario, face validity and was found to satisfy the requirement specification. This study provides a unified method for developing a computerized-based adherence model that can be applied among various disease groups and different drug categories.

Indiana University-Purdue University Indianapolis (IUPUI) / Medication non-adherence and non-compliance left unaddressed can compound into severe medical problems for patients. Identifying patients that are likely to become non-adherent can help reduce these problems. Despite these benefits, monitoring adherence at scale is cost-prohibitive. Social forums offer an easily accessible, affordable, and timely alternative to the traditional methods based on claims data. This study investigates the potential of medication adherence prediction based on social forum data for diabetes and fibromyalgia therapies by using transfer learning from the Medical Expenditure Panel Survey (MEPS). Predictive adherence models are developed by using both survey and social forums data and different random forest (RF) techniques. The first of these implementations uses binned inputs from k-means clustering. The second technique is based on ternary trees instead of the widely used binary decision trees. These techniques are able to handle missing data, a prevalent characteristic of social forums data. The results of this study show that transfer learning between survey models and social forum models is possible. Using MEPS survey data and the techniques listed above to derive RF models, less than 5% difference in accuracy was observed between the MEPS test dataset and the social forum test dataset. Along with these RF techniques, another RF implementation with imputed means for the missing values was developed and shown to predict adherence for social forum patients with an accuracy >70%. This thesis shows that a model trained with verified survey data can be used to complement traditional medical adherence models by predicting adherence from unverified, self-reported data in a dynamic and timely manner. Furthermore, this model provides a method for discovering objective insights from subjective social reports. Additional investigation is needed to improve the prediction accuracy of the proposed model and to assess biases that may be inherent to self-reported adherence measures in social health networks.

Mood disorders (MD) are among the most common mental disorders worldwide. Low treatment adherence and treatment resistance are two of the most substantial challenges facing clinicians who treat persons with MD. This thesis examined: (1) a pilot study investigating whether a one-on-one personalized medication training program, called PIMM/SAM, improves medication adherence in persons with MD; and (2) a systematic review and meta-analysis on the effects of electroconvulsive therapy (ECT) on cognitive functioning in persons with depression. To evaluate the impact of PIMM/SAM on medication adherence, a randomized controlled trial was launched in a mood disorders inpatient unit to compare PIMM/SAM (partnership in medication management/self-administered medication) program to standard prescribing practice (SPP). Over follow-up in the feasibility portion of the trial, participants in the PIMM/SAM group (n = 7) held fewer negative beliefs about medications and had lower depersonalization scores compared to participants in the SPP group (n = 5). Between-group differences on the Medication Adherence Rating Scale favoured the PIMM/SAM group, but were not statistically significant. To examine the effects of bilateral versus unilateral ECT on cognitive performance in persons with TRD, 18 studies across 10 different cognitive domains were meta-analyzed. In the 8- to 30-day timeframe post-ECT, persons who received bilateral versus unilateral ECT had over double the odds of worse cognitive performance in global cognition, non-verbal memory delayed recall, verbal memory immediate and delayed recall, subjective memory, and verbal memory immediate recall. A personalized medication training program in a mood disorders clinic may have positive implications for medication adherence. The trial to evaluate PIMM/SAM versus SPP is ongoing and further evidence about the training program is expected within the next 12 months. The systematic review and meta-analysis showed that cognitive performance was worse in persons who received bilateral versus unilateral ECT in some cognitive domains at 8 to 30 days post-treatment. / Thesis / Doctor of Philosophy (PhD) / Mood disorders (MD), including major depressive disorder (MDD) and bipolar disorder, are among the most common mental disorders worldwide. Treating MD is a challenge because of long treatments, the presence of other illnesses, treatment side effects, problems with memory, attention, and decision-making, a lack of understanding about medications, or incorrect beliefs about medication (BAM). Persons with MD who do not respond to drug treatment are often given electroconvulsive therapy (ECT). This thesis explored the challenges of treating persons with MD through: (1) a pilot study examining whether a one-on-one personalized medication training program, called PIMM/SAM, would help persons with MD take their medications as prescribed; and (2) a study of the effects of ECT on cognitive functioning in depression. Results: (1) participants randomized to PIMM/SAM group held fewer negative BAM than participants receiving standard care; (2) evidence showed worse cognitive functioning in persons who received more intense forms of ECT.

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