The research participant perspective related to the conduct of genomic cohort studies: A systematic review of the quantitative literature.

Observational genome-wide association studies require large sample sizes. Evaluating the interplay between genomic, environmental, and lifestyle factors can require even larger sample sizes. The All of Us Research Program will recruit 1 million participants to facilitate research on genomic, environmental, and lifestyle factors. Integrating participant preferences into the research process is a new paradigm and a necessary component of the All of Us Research Program. The purpose of the study is to summarize quantitative studies of participant preferences related to participation in observational genomic research studies, starting with consent through return of results. Integrating this information into the conduct of genomic studies may benefit participants, and improve participant satisfaction, recruitment, and retention. We conducted a systematic review of the literature regarding participant views related to reconsent and broad consent, use of de-identified data, contribution of data to a biorepository, risk of identification, return of individual genetic results, and motivation for participation in genomic studies. Twenty-three articles met our inclusion and exclusion criteria. Study results found that most participants support broad consent; however, significant differences related to reconsent preferences have been shown by gender and age. Most participants support the return of individual genomic results and do not feel it is necessary to maintain a link to their de-identified data. Reasons given for joining research studies varied by population source. These findings, in addition to the knowledge that participants are more accepting of broad informed consent methods when the rationale is explained, can assist in developing guidelines for future observational genomic research.

Why do indiviuals with schizophrenia drop out of observational clinical trials?

Randomized controlled trials (RCTs) and observational studies frequently differ with regard to study dropouts. The present naturalistic follow-up investigation aimed to shed a light on this issue by evaluating the time to and the reasons for study dropout in patients suffering from schizophrenia who started monotherapy with an oral new-generation antipsychotic. To this end, psychopathological symptoms and safety data were assessed in 194 patients who were followed up to a maximum observation period of twelve months. 9.3% of study participants completed the study. The mean time to study dropout was 2.6 ± 2.7 months with almost two thirds of patients dropping out within three months. 44.3% discontinued medication at the date of study dropout, the remainders dropped out due to withdrawal of written consent, logistic reasons, or nonappearance to the study visit ("loss to follow-up"), which were not necessarily to be equated with cessation of the antipsychotic. These findings indicate that in contrast to RCTs, dropout of observational studies is not necessarily associated with drug discontinuation. Accordingly, systematic differences between trial designs need to be considered when interpreting the results of clinical trials.

Estereotipia de Gênero nas Brincadeiras de Faz de Conta de Crianças Adotadas por Casais Homoparentais / Gender Stereotyping in Pretend Play among Children Adopted by Same-Sex Couples / Estereotipo de Género en Juegos de Haz de Cuenta de Niños Adoptados por Parejas del Mismo Sexo

Resumo O objetivo deste estudo foi investigar a estereotipia de gênero durante os episódios de brincadeiras de faz de conta entre crianças adotadas por casais homossexuais masculinos. A estereotipia de gênero nas brincadeiras infantis vem sendo constatada em diversos contextos, discutindo-se suas determinações biológica, individual e cultural. Este é um estudo observacional do qual participaram 13 crianças entre 3 a 7 anos, em 16 sessões, em uma sala de brinquedos em um Day Care no Canadá. Foram registrados 123 episódios de brincadeiras, sendo estes categorizados pela formação de grupos (número de participantes e gênero); tipo e tema das brincadeiras; e uso de objetos. Foram encontradas diferenças significativas para todos os critérios que caracterizam as brincadeiras como estereotipada para gênero, corroborando achados de estudos entre crianças educadas por casais heterossexuais. Meninos apresentaram episódios em grupos maiores e temas que exigiam mais uso do espaço, enquanto meninas brincaram em grupos menores e com mais uso de brinquedos.(AU)

Abstract The aim of this study was to investigate gender stereotyping during episodes of spontaneous pretend play among children adopted by gay male couples. Gender stereotyping in children's play has been reported in different contexts, regarding discussions on their biological, cultural and individual determination. This work is a naturalistic observational study that involved 13 children aged 3-7 years during 16 observation sessions in a Day care playroom. A total of 123 episodes were analyzed, which were categorized by group's formation (number of participants and gender); type and theme of the play; and use of objects. Significant differences were found for all criteria that characterize the play as gender-typed. These findings corroborate other studies among children raised by heterosexual couples. Boys had episodes in larger groups and themes that required more use of space, while girls played in smaller groups and used more toys.(AU)

Resumen El objetivo de este estudio fue investigar el estereotipo de género durante los episodios de juegos (Haz de Cuenta) entre niños adoptados por parejas homosexuales masculinos. El estereotipo de género en los juegos infantiles viene siendo constatado en diversos contextos, discutiéndose sus determinaciones biológica, individual y cultural. Este es un estudio de observación del cual participaron 13 niños, entre 3 a 7 años de edad, en 16 sesiones en una sala de juegos en un Day Care en Canadá. Fueron registrados 123 episodios de juegos, siendo clasificados por; formación de grupos (número de participantes y género); tipo y tema de los juegos; y uso de objetos. Fueron encontradas diferencias significativas para todos los criterios que caracterizan los juegos como estereotipo para género, corroborando resultados de estudios entre niños educados por parejas heterosexuales. Los niños presentaron episodios en grupos mayores y temas que exigían más uso del espacio, mientras que las niñas jugaban en grupos más pequeños y utilizaban más los juguetes.(AU)

Estereotipia de gênero nas brincadeiras de faz de conta de crianças adotadas por casais homoparentais / Gender stereotyping in pretend play among children adopted by same-sex couples / Estereotipo de género en juegos de haz de cuenta de niños adoptados por parejas del mismo sexo

O objetivo deste estudo foi investigar a estereotipia de gênero durante os episódios de brincadeiras de faz de conta entre crianças adotadas por casais homossexuais masculinos. A estereotipia de gênero nas brincadeiras infantis vem sendo constatada em diversos contextos, discutindo-se suas determinações biológica, individual e cultural. Este é um estudo observacional do qual participaram 13 crianças entre 3 a 7 anos, em 16 sessões, em uma sala de brinquedos em um Day Care no Canadá. Foram registrados 123 episódios de brincadeiras, sendo estes categorizados pela formação de grupos (número de participantes e gênero); tipo e tema das brincadeiras; e uso de objetos. Foram encontradas diferenças significativas para todos os critérios que caracterizam as brincadeiras como estereotipada para gênero, corroborando achados de estudos entre crianças educadas por casais heterossexuais. Meninos apresentaram episódios em grupos maiores e temas que exigiam mais uso do espaço, enquanto meninas brincaram em grupos menores e com mais uso de brinquedos.

The aim of this study was to investigate gender stereotyping during episodes of spontaneous pretend play among children adopted by gay male couples. Gender stereotyping in children's play has been reported in different contexts, regarding discussions on their biological, cultural and individual determination. This work is a naturalistic observational study that involved 13 children aged 3-7 years during 16 observation sessions in a Day care playroom. A total of 123 episodes were analyzed, which were categorized by group's formation (number of participants and gender); type and theme of the play; and use of objects. Significant differences were found for all criteria that characterize the play as gender-typed. These findings corroborate other studies among children raised by heterosexual couples. Boys had episodes in larger groups and themes that required more use of space, while girls played in smaller groups and used more toys.

El objetivo de este estudio fue investigar el estereotipo de género durante los episodios de juegos (Haz de Cuenta) entre niños adoptados por parejas homosexuales masculinos. El estereotipo de género en los juegos infantiles viene siendo constatado en diversos contextos, discutiéndose sus determinaciones biológica, individual y cultural. Este es un estudio de observación del cual participaron 13 niños, entre 3 a 7 años de edad, en 16 sesiones en una sala de juegos en un Day Care en Canadá. Fueron registrados 123 episodios de juegos, siendo clasificados por; formación de grupos (número de participantes y género); tipo y tema de los juegos; y uso de objetos. Fueron encontradas diferencias significativas para todos los criterios que caracterizan los juegos como estereotipo para género, corroborando resultados de estudios entre niños educados por parejas heterosexuales. Los niños presentaron episodios en grupos mayores y temas que exigían más uso del espacio, mientras que las niñas jugaban en grupos más pequeños y utilizaban más los juguetes.

Understanding motivations to participate in an observational research study: Why do patients enroll?

By understanding common motivations for participating in observational research studies, clinicians may better understand the perceived benefits of research participation from their clients' perspective. We enrolled 164 cardiac patients in a study about the effects of gratitude and optimism. Two weeks post-enrollment, participants completed a four-item questionnaire regarding motivations for study enrollment. Altruistic motivation ranked highest, while intellectual, health-related, and financial motivations rated lower. Four subgroups of participants emerged, each with distinct characteristics and different priorities for participating. These findings may help front-line clinicians to understand which motivations for participation apply to their clients who enroll in non-treatment-based research projects.

Guidelines for reporting evaluations based on observational methodology / Directrices para publicar evaluaciones basadas en metodología observacional

BACKGROUND: Observational methodology is one of the most suitable research designs for evaluating fidelity of implementation, especially in complex interventions. However, the conduct and reporting of observational studies is hampered by the absence of specific guidelines, such as those that exist for other evaluation designs. This lack of specific guidance poses a threat to the quality and transparency of these studies and also constitutes a considerable publication hurdle. The aim of this study thus was to draw up a set of proposed guidelines for reporting evaluations based on observational methodology. METHOD: The guidelines were developed by triangulating three sources of information: observational studies performed in different fields by experts in observational methodology, reporting guidelines for general studies and studies with similar designs to observational studies, and proposals from experts in observational methodology at scientific meetings. RESULTS: We produced a list of guidelines grouped into three domains: intervention and expected outcomes, methods, and results. CONCLUSIONS: The result is a useful, carefully crafted set of simple guidelines for conducting and reporting observational studies in the field of program evaluation

ANTECEDENTES: la metodología observacional es una de las más apropiadas para la evaluación de la fidelidad de la implementación, especialmente en el caso de intervenciones complejas. Sin embargo, a diferencia de lo que ocurre con otros diseños evaluativos, en este caso no existe una guía que delimite los componentes necesarios a incluir en el reporte de estudios observacionales, con lo que su divulgación, transparencia y calidad podrían quedar mermadas. El objetivo de este trabajo es proponer un protocolo específico para el reporte de estudios evaluativos basados en la metodología observacional. MÉTODO: la idoneidad del protocolo propuesto se basa en información procedente de estudios observacionales en distintos ámbitos realizados por expertos consolidados en metodología observacional; guías generales para cualquier tipo de diseño y específicas para diseños similares a los observacionales; y propuestas de expertos recibidas en reuniones científicas. RESULTADOS: se obtuvieron elementos a considerar para realizar un informe de metodología observacional, encuadrados en tres dominios: intervención y resultados esperados, método y resultados. CONCLUSIONES: se presenta un protocolo útil y parsimonioso para el desarrollo y elaboración de reportes de evaluación de programas con metodología observacional