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The overall purpose of this methodological study was to investigate the strengths and limitations of the randomized clinical trial design in examining the influence of treatment preferences on outcomes. The study was a secondary analysis of data obtained in two randomized clinical trials that evaluated behavioral therapies for insomnia. In both trials, the same design and methods were used to assess participants' treatment preferences and outcomes, however, the treatments differed. The results illustrated the challenges encountered in using the randomized clinical trial design. The challenges were related to the unbalanced distribution of participants with preferences for the study treatments, non-comparability of the subgroups with treatments matched or mismatched to their preferences, differential attrition, which compromised the sample size and composition of the subgroups and limited the use of the planned statistical analyses. Whether these challenges occur in trials of other types of treatments and target populations should be explored in future research. Some strategies were proposed and should be evaluated for their utility in addressing these challenges.
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Investigación en Enfermería , Prioridad del Paciente , Ensayos Clínicos Controlados Aleatorios como Asunto , HumanosRESUMEN
BACKGROUND: Long-term use of antiretroviral therapy, normal aging, and presence of certain risk factors are associated with metabolic disorders that predispose persons living with HIV to diabetes and cardiovascular diseases. The emergence and progression of these disorders can be prevented by adopting healthy behaviours. Based on the theory of planned behaviour, the Web-based tailored intervention TAVIE en santé was developed. The aim of this study is to evaluate the effectiveness of TAVIE en santé in order to support people living with HIV in the adoption of health promoting behaviours. METHODS/DESIGN: An online randomized controlled trial with parallel-groups will be conducted across Canada. To participate in this study, people living with HIV must be: ≥ 18 years, able to read/understand French or English, have access to the Internet. A convenience sample of 750 participants will be randomly assigned either to an experimental group (TAVIE en santé, n = 375) or to a control group (websites, n = 375) (1:1 allocation ratio). The TAVIE en santé intervention is composed of seven interactive computer sessions, lasting between 5 and 10 min. The sessions, hosted by a virtual nurse, aim to develop and strengthen skills required for behaviour change. The control group will receive a validated list of five predetermined conventional health-related Websites. The adoption of health behaviour (smoking cessation or physical activity or healthy eating) is the principal outcome. Cognitions (intention, attitude, perceived behavioral control) are the secondary outcomes. Health indicators will also be assessed. All outcomes will be measured with a self-administered online questionnaire and collected three times: at baseline, 3 and 6 months after. The principal analyses will focus on differences between the two trial groups using Intention-to-Treat analysis. DISCUSSION: This study will yield new results about the efficacy of Web-based tailored health behaviours change interventions in the context of chronic disease. The TAVIE en santé intervention could constitute an accessible complementary service in support of existing specialized services to support people living with HIV adopt health behaviors. TRIAL REGISTRATION: NCT02378766 , assigned on March 3th 2015.
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Quimioterapia Asistida por Computador/métodos , Infecciones por VIH/enfermería , Infecciones por VIH/prevención & control , Educación en Salud/métodos , Internet/estadística & datos numéricos , Adulto , Anciano , Fármacos Anti-VIH/uso terapéutico , Canadá , Femenino , Infecciones por VIH/tratamiento farmacológico , Humanos , Masculino , Persona de Mediana Edad , Proyectos de Investigación , Autocuidado/métodos , Adulto JovenRESUMEN
The purpose of this methodological study was to examine the contribution of treatment allocation method (random vs. preference) on the immediate, intermediate, and ultimate outcomes of a behavioural intervention (MCI) for insomnia. Participants were allocated to the MCI randomly or by preference. Outcomes were assessed before, during, and after completion of the MCI using validated self-report measures. Analysis of covariance was used to compare the post-test outcomes for the 2 groups, controlling for baseline differences. Compared to those randomized, participants in the preference group showed improvement in most immediate outcomes (sleep onset latency, wake after sleep onset, sleep efficiency), both intermediate outcomes (insomnia severity and daytime fatigue), and one ultimate outcome (resolution of insomnia). Using a systematic method for eliciting participants' preferences and involving participants in treatment selection had a beneficial impact on immediate and intermediate outcomes. Additional research should validate the mechanism through which treatment preferences contribute to outcomes.
La présente étude méthodologique vise à analyser l'incidence de la méthode d'attribution des traitements (aléatoire ou fondée sur les préférences) sur les résultats immédiats, intermédiaires et ultimes d'une intervention comportementale (MCI) destinée à traiter l'insomnie. Les participants se sont vu attribuer une MCI selon une méthode aléatoire ou fondée sur les préférences. Les résultats ont été analysés avant, pendant et après la fin de la thérapie à l'aide d'un instrument d'autoévaluation validé. Une analyse de la covariance a servi à comparer les résultats au post-test des deux groupes en tenant compte des différences de départ. La comparaison montre une amélioration chez les sujets du groupe avec attribution fondée sur les préférences en ce qui concerne la plupart des résultats immédiats (latence du sommeil, temps d'éveil après l'endormissement, efficacité du sommeil), les deux résultats intermédiaires (gravité de l'insomnie, fatigue diurne) et un résultat ultime (résolution des problèmes d'insomnie). Le fait d'avoir recouru à une méthode systématique pour amener les sujets à exprimer leurs préférences et à les faire participer au choix du traitement a eu un effet bénéfique sur les résultats immédiats et intermédiaires. D'autres recherches devraient permettre de valider le mécanisme par lequel les préférences en matière de traitement contribuent aux résultats.
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Preferences for treatment contribute to attrition. Providing participants with their preferred treatment, as done in a partially randomized clinical or preference trial (PRCT), is a means to mitigate the influence of treatment preferences on attrition. This study examined attrition in an RCT and a PRCT. Persons with insomnia were randomly assigned (n = 150) or allocated (n = 198) to the preferred treatment. The number of dropouts at different time points in the study arms was documented and the influence of participant characteristics and treatment-related factors on attrition was examined. The overall attrition rate was higher in the RCT arm (46%) than in the PRCT arm (33%). In both arms, differences in sociodemographic and clinical characteristics were found between dropouts and completers. The type of treatment significantly predicted attrition (all p ≤ .05). The results provide some evidence of a lower attrition rate in the PRCT arm, supporting the benefit of accounting for preferences as a method of treatment allocation.
Les préférences en matière de traitement influent sur le taux d'abandon. Offrir aux participants le traitement qui correspond à leurs préférences, comme dans le cadre d'un essai clinique avec répartition partiellement aléatoire ou selon les préférences, constitue un moyen d'atténuer l'incidence de la préférence en matière de traitement sur le taux d'abandon. La présente étude examine les taux d'abandon observés lors d'un essai clinique avec répartition aléatoire et d'un essai clinique avec répartition partiellement aléatoire ou selon les préférences. Un groupe de personnes souffrant d'insomnie se sont vu attribuer une thérapie comportementale de façon aléatoire (n = 150) et les membres d'un autre groupe selon leurs préférences (n = 198). Le nombre d'abandons au sein de chacun des groupes a été consigné à différents moments de l'étude, puis une analyse des caractéristiques des participants et des facteurs liés à chaque thérapie a été effectuée afin de déterminer leur influence sur le taux d'abandon. Le taux d'abandon global s'est avéré plus élevé au sein du groupe avec attribution aléatoire de la thérapie (44 %) qu'au sein de l'autre groupe (33 %). Dans les deux groupes, des différences d'ordre sociodémographique et liées à des caractéristiques cliniques ont été observées entre les participants ayant abandonné et ceux qui ont terminé la thérapie. Le type de thérapie suivi permettait de prédire de façon notable s'il y aurait abandon (tout p ≤ 0,05). Les résultats montrent un taux d'abandon moins élevé parmi les participants qui se sont vu attribuer une thérapie selon leurs préférences, ce qui appuie l'hypothèse selon laquelle il y a un avantage à tenir compte des préférences dans la méthode d'attribution des traitements.
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Adherence to treatment is critical in determining the effects of behavioural therapy and may be affected by participants' preference for treatment. The purpose of this study was to determine the extent to which method of allocation to treatment (random vs. preference-based) influences adherence (exposure and enactment) to behavioural therapy. Participants received behavioural therapy for the management of insomnia randomly or by preference. Exposure was assessed as attendance at the treatment sessions, enactment as self-reported application of treatment recommendations. Participants (N = 262) attended a mean of 5.6 treatment sessions, applied the treatment recommendations frequently, and reported high levels of overall compliance. There was no difference between the random and preference groups in terms of exposure to and enactment of treatment. Randomization to the preferred treatment, dissatisfaction with the allocated treatment, and self-report bias could play a role in the findings and should be explored in future research.
L'adhésion au traitement a un effet déterminant sur l'efficacité d'une thérapie comportementale et est susceptible d'être influencée par les préférences des participants en matière de traitement. L'objectif de la présente étude est de déterminer la mesure dans laquelle la méthode d'attribution des traitements (aléatoire ou fondée sur les préférences) exerce une influence sur l'adhésion (exposition ou mise en action) à une thérapie comportementale. Les participants à l'étude se sont vu attribuer une thérapie pour la gestion de l'insomnie selon une méthode aléatoire ou fondée sur leurs préférences. L'exposition a été définie et évaluée comme une présence aux séances de thérapie et la mise en action comme l'application des recommandations associées à la thérapie, selon les déclarations des participants eux-mêmes. Les participants (N = 262) ont assisté en moyenne à 5,6 séances de thérapie, ont appliqué les recommandations associées à la thérapie de façon fréquente et ont indiqué avoir fait preuve d'un degré élevé de respect de la thérapie en général. Aucune différence n'a été observée entre les groupes avec attribution aléatoire et ceux avec attribution selon les préférences en ce qui concerne l'exposition à la thérapie et la mise en action de celle-ci. La répartition aléatoire des participants à la thérapie préférée, l'insatisfaction de participants quant à la thérapie attribuée et le caractère subjectif des déclarations des participants ont possiblement joué un rôle dans l'établissement des résultats et devraient être analysés plus en profondeur dans le cadre d'une prochaine étude.
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BACKGROUND: Empirical evidence pertaining to the influence of treatment preferences on attrition, adherence and outcomes in intervention evaluation trials is inconsistent. The inconsistency can be explained by the method used for allocating treatment and measuring preferences. The current methodological study is designed to address these factors by implementing the two-stage partially randomized or preference trial design, and administering a validated measure to assess participants' preferences for the treatments under evaluation. It aims to compare attrition, adherence and outcomes for participants allocated randomly or by preference to treatment. The study is in its final stages of data collection; its protocol is presented in this paper. METHODS/DESIGN: A partially randomized clinical or preference trial is used. Eligible participants are randomized to two trial arms. First is the random arm involving random assignment to treatments, and second is the preference arm involving allocation to the chosen treatment. Participants with chronic insomnia are targeted. Two behavioral treatments are offered, stimulus control therapy and sleep restriction therapy, in the same format (small group) and dose (two sessions given over a 4-week period). A participant log is used to collect data on attrition. Adherence is evaluated in terms of exposure and enactment of treatment. Sleep-related outcomes (sleep parameters and perceived insomnia severity) are measured at pretest, posttest, 6 and 12 month follow-up. Treatment preferences, adherence and outcomes are assessed with reliable and valid measures. DISCUSSION: The advantages and limitations of the preference trial design are highlighted. The challenges in implementing the trial are discussed relative to the distribution of participants in the groups defined by treatment received and method of treatment allocation. TRIAL REGISTRATION: ClinicalTrials.gov Registry NCT02513017.
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Differences in the conceptualization and operationalization of health-related concepts may exist across cultures. Such differences underscore the importance of examining conceptual equivalence when adapting and translating instruments. In this article, we describe an integrated method for exploring conceptual equivalence within the process of adapting and translating measures. The integrated method involves five phases including selection of instruments for cultural adaptation and translation; assessment of conceptual equivalence, leading to the generation of a set of items deemed to be culturally and linguistically appropriate to assess the concept of interest in the target community; forward translation; back translation (optional); and pre-testing of the set of items. Strengths and limitations of the proposed integrated method are discussed.
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Actitud Frente a la Salud/etnología , Diversidad Cultural , Multilingüismo , Evaluación en Enfermería/métodos , Traducción , Barreras de Comunicación , Comparación Transcultural , Recolección de Datos/métodos , Emigrantes e Inmigrantes/psicología , Grupos Focales , Conocimientos, Actitudes y Práctica en Salud , Humanos , Entrevistas como Asunto , Investigación en Evaluación de Enfermería , Psicometría , Proyectos de Investigación , Semántica , Valores Sociales , Maltrato Conyugal/etnología , Sri Lanka/etnología , Estudios de Validación como AsuntoRESUMEN
â¢Less than a quarter of psychological interventions are developed based on evidence.â¢Evaluation of the effectiveness of existing online mental health resources is required.â¢Front-line healthcare providers experienced severe mental distress during COVID-19.
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Systematic measurement of treatment preferences is needed to obtain well-informed preferences. Guided by a conceptualization of treatment preferences, a measure was developed to assess treatment acceptability and preference. The purpose of this study was to evaluate the psychometric properties of the treatment acceptability and preferences (TAP) measure. The TAP measure contains a description of each treatment under evaluation, items to rate its acceptability, and questions about participants' preferred treatment option. The items measuring treatment acceptability were internally consistent (alpha > .80) and demonstrated validity, evidenced by a one-factor structure and differences in the scores between participants with preferences for particular interventions. The TAP measure has the potential for the assessment of acceptability and preferences for various behavioral interventions.
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Satisfacción del Paciente , Trastornos del Inicio y del Mantenimiento del Sueño/terapia , Encuestas y Cuestionarios , Adulto , Enfermedad Crónica , Análisis Factorial , Femenino , Humanos , Masculino , Persona de Mediana Edad , Reproducibilidad de los ResultadosRESUMEN
The partial RCT is a modified design meant to account for participants' treatment preferences. Little is known about the factors that influence such preferences. This study investigated the extent to which participants are willing to be randomized and the factors that affect their treatment preferences. The quantitative and qualitative data collected as part of a partial RCT evaluating 2 behavioural interventions for insomnia were analyzed. Of the participants, 75% were unwilling to be randomly allocated to a treatment group. This figure increased to 90% after information on the 2 interventions was provided. Participants' knowledge of the treatment, its suitability, and their perceived ability to adhere to it influenced their treatment preference.A few participants who had no strong preference and who required treatment were willing to be randomized. The findings raise questions about the impact of treatment preference and allocation procedures on the validity of study conclusions.
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Random assignment of participants to experimental and comparison treatments is believed to enhance the comparability of the study groups on baseline characteristics. Despite its benefits, random assignment presents threats to validity. It ignores participants' treatment preferences. If not accounted for when participants are allocated to treatments, preferences influence enrolment in the study, representativeness of the accrued sample, attrition, adherence to treatment, and outcomes. This methodological article describes the mechanisms underlying the influence of treatment preferences on the external and internal validity of an intervention evaluation study. The authors present empirical evidence to support the points of discussion. They describe alternative research designs that account for treatment preferences, for use in future nursing intervention research.
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Actitud Frente a la Salud , Conducta de Elección , Investigación en Evaluación de Enfermería/métodos , Selección de Paciente , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Proyectos de Investigación , Sujetos de Investigación/psicología , Sesgo , Humanos , Investigación en Evaluación de Enfermería/normas , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Reproducibilidad de los Resultados , Proyectos de Investigación/normasRESUMEN
BACKGROUND: Evaluations of interventions should be carefully designed and conducted to maintain a balance between internal and external validity, with the dual goal of minimising the influence of potential confounders and improving the generalisability or applicability of any findings to practice. AIM: To review strategies to promote balance between internal and external validity in an evaluation of a cognitive-behavioural intervention for chronic insomnia. DISCUSSION: A pragmatic approach is needed to balance internal and external validity, and generate evidence relevant to practice. The authors present strategies to promote such a balance, including using strict eligibility criteria, subgroup analysis, random assignment of patients based on preferences, a no-treatment control condition, and standardised and consistent implementation of the intervention. CONCLUSION: A balance between internal and external validity is essential to promote enrolment in the study and confidence in attributing its outcomes to an intervention, as well as to provide answers to clinically relevant questions such as who benefits most from which intervention. IMPLICATIONS FOR PRACTICE: The authors recommend researchers conduct a pilot study in advance of an evaluation, to help decide which strategies to use and how to balance internal and external validity.
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Investigación en Enfermería/organización & administración , Humanos , Reproducibilidad de los ResultadosRESUMEN
Patient-centered care involves the provision of treatments that are responsive to patients' preferences. This study aimed to examine the psychometric properties of the Treatment Perception and Preferences measure. Participants ( n = 128) completed the measure relative to pharmacological, educational, and behavioral treatments for the management of insomnia. For each treatment, the measure presents a description of its goal, activities, mode and dose of delivery, and nine items to rate its perceived acceptability. All items measuring perception of treatment were internally consistent (α > .85) and loaded on one factor, except the item assessing severity of side effects. Differences in the measure's scores between groups of participants provided evidence of validity: participants with a preference for a particular treatment rated it more favorably than alternative treatments. The measure provides a systematic and efficient method for eliciting well-informed treatment preferences. Its use in practice should be investigated.
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Prioridad del Paciente , Satisfacción del Paciente , Psicometría , Terapia Cognitivo-Conductual , Fatiga , Femenino , Humanos , Masculino , Persona de Mediana Edad , Atención Dirigida al Paciente , Reproducibilidad de los Resultados , Trastornos del Inicio y del Mantenimiento del Sueño/tratamiento farmacológico , Encuestas y CuestionariosRESUMEN
BACKGROUND: Many HIV (human immunodeficiency virus) prevention interventions are currently being implemented and evaluated, with little information published on their development. A framework highlighting the method of development of an intervention can be used by others wanting to replicate interventions or develop similar interventions to suit other contexts and settings. It provides researchers with a comprehensive development process of the intervention. OBJECTIVE: The objective of this paper was to describe how a systematic approach, intervention mapping, was used to develop a tailored Web-based intervention to increase condom use among HIV-positive men who have sex with men. METHODS: The intervention was developed in consultation with a multidisciplinary team composed of academic researchers, community members, Web designers, and the target population. Intervention mapping involved a systematic process of 6 steps: (1) needs assessment; (2) identification of proximal intervention objectives; (3) selection of theory-based intervention methods and practical strategies; (4) development of intervention components and materials; (5) adoption, implementation, and maintenance; and (6) evaluation planning. RESULTS: The application of intervention mapping resulted in the development of a tailored Web-based intervention for HIV-positive men who have sex with men, called Condom-HIM. CONCLUSIONS: Using intervention mapping as a systematic process to develop interventions is a feasible approach that specifically integrates the use of theory and empirical findings. Outlining the process used to develop a particular intervention provides clarification on the conceptual use of experimental interventions in addition to potentially identifying reasons for intervention failures.
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BACKGROUND: Learner-oriented strategies focusing on learning processes are needed to prepare nursing students for complex practice situations. An arts-based learning approach uses art to nurture cognitive and emotional learning. Knowles' theory of andragogy aims to develop the skill of learning and can inform the process of implementing arts-based learning. This article explores the use and evaluation of andragogy-informed arts-based learning for teaching nursing theory at the undergraduate level. METHOD: Arts-based learning activities were implemented and then evaluated by students and instructors using anonymous questionnaires. RESULTS: Most students reported that the activities promoted learning. All instructors indicated an interest in integrating arts-based learning into the curricula. Facilitators and barriers to mainstreaming arts-based learning were highlighted. Findings stimulate implications for prospective research and education. CONCLUSION: Findings suggest that arts-based learning approaches enhance learning by supporting deep inquiry and different learning styles. Further exploration of andragogy-informed arts-based learning in nursing and other disciplines is warranted. [J Nurs Educ. 2016;55(7):407-410.].
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Arte , Bachillerato en Enfermería/métodos , Aprendizaje , Modelos Educacionales , Teoría de Enfermería , Aprendizaje Basado en Problemas , Adulto , Curriculum , Evaluación Educacional , Femenino , Humanos , Masculino , Encuestas y CuestionariosRESUMEN
Resumo Objetivos Descrever a experiência da implementação de um programa de treinamento de assistente de pesquisa voluntário para graduandos canadenses de Enfermagem, objetivando o desenvolvimento de habilidades de comunicação verbal e escrita, métodos de pesquisa e análise de dados, pensamento crítico e resolução de problemas, assim como o planejamento de suas carreiras e o avanço de seus papéis relacionados à pesquisa e às oportunidades administrativas e de liderança. Método Estudo descritivo com relato de experiência sobre o processo de treinamento para um novo papel profissional relativo ao engajamento dos graduandos em 11 oficinas, cada uma com duração de uma hora e o processo de apoiá-los para assumir papéis profissionais e de liderança. Resultados Os graduandos demonstraram comprometimento em todas as fases do treinamento. Destaca-se, ainda, o interesse por assumirem a liderança em atividades práticas que redefinem seu perfil profissional. Essa experiência contribuiu para construir e nutrir relações intelectuais docentes-graduandos. Os graduandos expandiram suas redes profissionais e a relação com o mentor de carreira, estão desenvolvendo suas habilidades práticas e relataram confiança em se candidatar para cargos de assistentes de pesquisa. Conclusão e implicações para a prática O treinamento pode instrumentalizá-los para escolhas de planos de carreira, ingresso no mercado de trabalho e a construção de plano para desenvolvimento profissional. O desejo genuíno dos docentes de Enfermagem, apoiando uma nova geração de enfermeiros, culminou nessa experiência de empoderamento mútuo.
Resumen Objetivos Informar sobre la experiencia de un equipo de profesionales de enfermería y desarrollo profesional en la implementación de un programa de asistente voluntario de investigación para estudiantes universitarios canadienses de pregrado en enfermería con el objetivo de desarrollar la comunicación escrita y verbal, métodos de investigación, análisis de datos, pensamiento crítico y habilidades de resolución de problemas, así como en su planificación y avance profesional para funciones relacionadas con la investigación y oportunidades de empleo administrativo y de liderazgo. Método Un diseño descriptivo con el informe de la experiencia de los investigadores de enfermería y desarrollo profesional sobre el proceso de apoyo para la formación de los estudiantes para un nuevo rol profesional. La experiencia se refiere a 11 talleres que durarán una hora sobre los temas relacionados con la investigación. Resultados Los estudiantes demostraron compromiso con la capacitación. Relevante es su interés en liderar actividades prácticas para redefinir su perfil profesional. Esta experiencia contribuyó a construir y fomentar relaciones significativas e intelectuales entre los profesores y los estudiantes. Los estudiantes amplían sus redes profesionales y obtienen una relación con un mentor de carrera. Conclusión e implicaciones para la práctica La capacitación puede equipar mejor a los estudiantes para elegir trayectorias profesionales, entrar en el mercado laboral y elaborar un plan para el avance profesional. Fue el deseo genuino de los profesores de enfermería de apoyar a una nueva generación de enfermeras que culminó en esta experiencia de empoderamiento mutuo.
Abstract Objective To describe the experience of implementing a research assistant program for Canadian undergraduate nursing students, which aimed to develop written and verbal communication, critical thinking and problem-solving skills, as well as knowledge of various research methods. Engagement in this program was intended to support students' career planning and advancement in research related roles, including administrative and leadership employment opportunities. Method A descriptive design with the report of experience of nursing researchers and career advisers pertaining to: engagement in an 11 one-hour research focused workshop; and the process of supporting students to assume professional and leadership roles. Results Students demonstrated commitment to the training program throughout its phases. They expressed interest in leading practical activities to redefine their professional profile. This experience contributed to building and nurturing intellectual teacher-student relationships. Students are expanding their professional networks and a relationship with a career mentor, while demystifying the research assistant role. Students are developing practical skills and reporting confidence in applying for research assistant positions. Conclusion and Implications for practice Participating in the training program better equips students for choosing their career path, entering the job market, and building a plan for further career advancement. Nursing faculty's genuine desire for and purposeful actions to support a new generation of nurses informed this mutually empowering experience.
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Humanos , Investigación/educación , Educación Basada en Competencias/métodos , Educación en Enfermería/métodos , Facultades de Enfermería , Estudiantes de Enfermería , Docentes de Enfermería , Tutoría/métodosRESUMEN
The partial RCT is a modified design meant to account for participants' treatment preferences. Little is known about the factors that influence such preferences. This study investigated the extent to which participants are willing to be randomized and the factors that affect their treatment preferences. The quantitative and qualitative data collected as part of a partial RCT evaluating 2 behavioural interventions for insomnia were analyzed. Of the participants, 75% were unwilling to be randomly allocated to a treatment group. This figure increased to 90% after information on the 2 interventions was provided. Participants' knowledge of the treatment, its suitability, and their perceived ability to adhere to it influenced their treatment preference. A few participants who had no strong preference and who required treatment were willing to be randomized. The findings raise questions about the impact of treatment preference and allocation procedures on the validity of study conclusions.
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Conducta de Elección , Participación del Paciente/psicología , Ensayos Clínicos Controlados Aleatorios como Asunto/psicología , Adulto , Terapia Conductista/normas , Femenino , Conocimientos, Actitudes y Práctica en Salud , Humanos , Masculino , Persona de Mediana Edad , Investigación Metodológica en Enfermería , Ontario , Educación del Paciente como Asunto/normas , Selección de Paciente , Investigación Cualitativa , Proyectos de Investigación/normas , Trastornos del Inicio y del Mantenimiento del Sueño/psicología , Trastornos del Inicio y del Mantenimiento del Sueño/terapia , Encuestas y CuestionariosRESUMEN
BACKGROUND: In the recent years, the Internet has been used as a medium to find sexual partners and engage in risky sexual behavior. This has changed the way in which men having have sex with men (MSM) seek sexual partners and has increased the number of high-risk sexual encounters. Therefore, developers of human immunodeficiency virus (HIV)-prevention interventions have also started using the Internet as a viable medium to promote safe sexual behaviors. However, much of the efforts thus far have been aimed at HIV-negative rather than HIV-positive MSM. HIV-positive individuals continue to engage in risky sexual behaviors and thus constitute an important group in which HIV prevention strategies need to be addressed. Therefore, HIV prevention in HIV-positive MSM is a critical issue. OBJECTIVE: Condom-Him, an Internet-based intervention tailored to increase condom use among HIV-positive MSM, was developed with the aim of improving condom use, self-efficacy, and intentions to use condoms among these individuals. The acceptability and feasibility of this Internet-based intervention will be examined in a pilot study. METHODS: We will perform a randomized controlled parallel-group superiority trial. HIV-positive MSM who currently engage in unprotected anal sex will be recruited for the study. Participants will be randomly assigned using a one-to-one allocation ratio generated by the computer program. The researchers will be blinded to participant's group assignment. Participants will be assigned either to use the Condom-Him intervention (experimental arm) or to view a list of websites containing HIV/AIDS related information (control arm). Self-administered questionnaires will be provided online before randomization (baseline) and two weeks after intervention (post-test). RESULTS: The study will include a total of 60 participants with 30 in each group. The results from this pilot study will provide further evidence for a larger study to examine the effectiveness of this intervention and will provide a cost-effective and widely accessible approach to HIV prevention for HIV-positive MSM. CONCLUSIONS: Internet-based interventions for HIV-positive MSM, a population that has been under-represented in the efforts for positive prevention of HIV within Canada, have the potential to provide a cost-effective strategy, which influences the way in which information is accessed and provided to high-risk individuals. The advantages of an Internet-based intervention include the potential to provide consistency in the delivery of an intervention and the ability to disseminate the intervention to a wider population. Internet-based interventions are perceived as vital tools in combating HIV infection within the realm of social media. Therefore, it is important to determine the feasibility and acceptability of these interventions before implementing them. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01726153; http://clinicaltrials.gov/ct2/show/NCT01726153 (Archived by WebCite at http://www.webcitation.org/6Jljzip8B).
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BACKGROUND: The literature on preferences for behavioral interventions is limited in terms of understanding treatment-related factors that underlie treatment choice. The objectives of this study were to examine the direct relationships between personal beliefs about clinical condition, perception of treatment acceptability, and preferences for behavioral interventions for insomnia. METHODS: The data set used in this study was obtained from 431 persons with insomnia who participated in a partially randomized clinical trial and expressed preferences for treatment options. The data were collected at baseline. Logistic regression was used to examine the relationships between personal beliefs and treatment acceptability, and preferences. The relationships between personal beliefs and perception of treatment acceptability were explored with correlational analysis. RESULTS: Perception of treatment acceptability was associated with preferences. Persons viewing the option as convenient tended to choose that option for managing insomnia. Personal beliefs were not related to preferences. However, beliefs about sleep promoting behaviors were correlated with perceived treatment effectiveness. CONCLUSIONS: Perception of treatment acceptability underlies expressed preferences for behavioral interventions. Personal beliefs about insomnia are not directly associated with preferences. Importance is highlighted for providing information about treatment options and exploring perception of each option's acceptability during the process of treatment selection.
Asunto(s)
Terapia Conductista , Cultura , Aceptación de la Atención de Salud , Prioridad del Paciente , Adulto , Anciano , Anciano de 80 o más Años , Conducta de Elección , Femenino , Humanos , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Ensayos Clínicos Controlados Aleatorios como Asunto , Trastornos del Inicio y del Mantenimiento del Sueño/psicología , Trastornos del Inicio y del Mantenimiento del Sueño/terapiaRESUMEN
BACKGROUND: The integrated patient-centered evidence-based approach to care is integral to guide practice and enhance the quality of care. In this paper, a strategy to operationalize the integrated approach is described. DESCRIPTION OF STRATEGY: The strategy flows from the processes used to synthesize the best available evidence for interventions that address a clinical problem, and to elicit patient preferences for treatment options, which is an important step in patient-centered care. The strategy consists of three phases: (1) synthesis of evidence about the effectiveness and relevance of interventions derived from research and practice; (2) generation of written material describing the nature, dose, effectiveness, and risks associated with the evidence-based interventions; and (3) using the written descriptions to elicit patient preferences. Examples from an ongoing study are presented to illustrate the implementation of the strategy within the context of research. IMPLICATIONS: Nurses are invited to apply the strategy in practice and to evaluate its feasibility and utility in enhancing the quality of care.