Consent to discuss participation in research: a pilot study.

BACKGROUND: Equitable access to research studies needs to be increased for all patients. There is debate about which is the best approach to use to discuss participation in research in real-world clinical settings. OBJECTIVE: We aimed to determine the feasibility of asking all clinical staff within one hospital Trust (an organisation that provides secondary health services within the English and Welsh National Health Service) to use a newly created form on the Trust's electronic patient records system, as a means of asking patients to consent to discuss participation in research (the opt-in approach). We also aimed to collect feedback from patients and clinicians about their views of the opt-in approach. METHODS: Four pilot sites were selected in the Trust: two memory clinics, an adult mental health team and an acute adult ward. Data were collected in three phases: (1) for 6 months, pilot site staff were asked to complete a consent to discuss participation in research form with patients; (2) staff feedback on the form was collected through an online survey; and (3) patient feedback was collected through focus groups. FINDINGS: Of 1779 patients attending services during the pilot period, 197 (11%) had a form completed by staff and 143 (8%) opted-in to finding out about research. Staff cited limited time, low priority and poor user experience of the electronic patient records system as reasons for low uptake of the form. Patients generally approved of the approach but offered suggestions for improvement. CONCLUSIONS: There were mixed results for adopting an opt-in approach; uptake was very low, limiting its value as an effective strategy for improving access to research. CLINICAL IMPLICATIONS: Alternative strategies to the opt-in approach, such as transparent opt out approaches, warrant consideration to maximise access to research within routine clinical care.

[Data linkage - respondents consent without selectivity?]. / Zustimmung von Befragten zur Verknüpfung von Daten - selektionsfrei?

OBJECTIVE: The lidA Study is designed as a longitudinal survey. The respondent's consent is mandatory for storing sample data. Moreover, the survey data shall be linked with social security data of the Federal Employment Agency and individual's health insurance claims data in case of the respondent's written consent. This essay pursues the issue of whether this methodologically challenging objective of obtaining 3 consents within one study could be met without any selectivity. METHODOLOGY: The data basis is a cohort study with 2 cohorts of a representative sample of employed individuals subject to social security contributions. The sample was interviewed for the first time in 2011. The analysis dataset comprises 6 585 respondents. RESULTS: Selectivity analyses prove that the realisation of the first measurement's sample turned out to be representative as well as unbiased. As expected, more respondents stated their willingness to remain in the panel and also consented to linkage of social security data than those who consented to linkage of health insurance claims data. All 3 consents were given without resulting in any bias. Even linking all 3 consents does result in minimal effects of a few subgroups only. CONCLUSION: A significant number of respondents can be motivated to participate due to proper placement of the questions concerning consent and the provision of insight into the use of the data.

[Integration of primary and secondary data in the Study of Health in Pomerania and description of clinical outcomes using stroke as an example]. / Die Integration von Primär- und Sekundärdaten in der Study of Health in Pomerania und die Beschreibung von klinischen Endpunkten am Beispiel Schlaganfall.

OBJECTIVE: This study describes (i) the procedure of obtaining patients' consent for secondary data usage, (ii) the complexity of integrating data from multiple sources, and (iii) the correspondence among patients' self-reports, physician reports, routine data, hospital discharge diagnosis, and cause-of-death coding regarding stroke. METHODS: Data from the first follow-up (N=3 186) of the population-based Study of Health in Pomerania (SHIP) were used. These data were combined with secondary data from the Greifswald University Hospital, the association of statutory health insurance physicians Mecklenburg-Western Pomerania, physician reports, and death certificates. RESULTS: Consent for using health-related information from all data sources in question was obtained from more than 90% of the SHIP participants. Follow-up data from at least one source were available for 2 747 (86%) participants. For 92 participants information about the occurrence of stroke was found in at least one data source. In 59 cases the event appeared in only one data source, in 24 cases the event was found in 2 sources, and for 9 participants 3 data sources reported on the event. CONCLUSION: Participants of a population-based cohort are highly willing to give consent for using their health-related information from secondary data sources. Yet, data integration is challenging due to considerable differences in data type, structure and coverage.

Pleural procedures and patient safety: a national BTS audit of practice.

The BTS pleural procedures audit collected data over a 2-month period in June and July 2011. In contrast with the 2010 audit, which focussed simply on chest drain insertions, data on all pleural aspirations and local anaesthetic thoracoscopy (LAT) was also collected. Ninety hospitals submitted data, covering a patient population of 33 million. Twenty-one per cent of centres ran a specialist pleural disease clinic, 71% had a nominated chest drain safety lead, and 20% had thoracic surgery on site. Additionally, one-third of centres had a physician-led LAT service.

Significados de la vinculación universidad-comunidad para los actores sociales involucrados en la cátedra Enfermería Comunitaria del Decanato de Ciencias de la Salud en la Universidad Centroccidental «Lisandro Alvarado» / Meanings of the university links-community for actors involved in community nursing chair of the dean of science university health Centrocidental «Lisandro Alvarado»

El presente estudio tuvo como objetivo general conocer los significados de la vinculación Universidad-Comunidad para los actores sociales involucrados con la Cátedra Enfermería Comunitaria del Decanato de Ciencias de la Salud en la Universidad Centroccidental «Lisandro Alvarado». Tuvo un enfoque fenomenológico, basándose en los referentes teóricos del Interaccionismo Simbólico, Estructuralismo Dialéctico y el Existencialismo de Husserl. Se seleccionaron nueve (09) actores sociales, tres (03) docentes, tres (03) estudiantes del octavo semestre y tres (03) miembros del comité de salud de la comunidad de Las Tunas en el pueblo de Tamaca. Se utilizó la técnica de la entrevista abierta para obtener la información de la que emergieron los significados mediante la interpretación. Los hallazgos mostraron que: 1) Para los docentes existe un significado claro y definido de Enfermería Comunitaria y de lo que se espera de los estudiantes. 2) Para los estudiantes, a través de los significados que le dieron a sus propias experiencias, desempeñan un rol dinámico, sin embargo, muchos de ellos expresaron que no tienen vocación para el desempeño de trabajos comunitarios, a pesar de poseer los conocimientos en este campo. 3) Para los miembros de la comunidad mediante el significado que le dieron a su experiencia se evidenció que existen cambios importantes en el desarrollo de las actividades, pero afirmaron que se deben fortalecer los valores. Como reflexiones finales se reveló que existe una vinculación entre la universidad y la comunidad la cual es débil en algunos aspectos, como recursos, perfil comunitario y vocación del estudiante(AU)

This study aimed to generally know the meanings of the University-Community link to social actors involved with the Department of Community Nursing Dean of Health Sciences at the University «Lisandro Alvarado». It took a phenomenological approach based on the references Symbolic Interaction theory, structuralism and existentialism Dialectic of Husserl. We selected nine (09) social actors, three (03) teachers, three (03) students of the eighth semester and three (03) members of the health committee of the community of Las Tunas in the village of Tamaca. We used open interview technique to get the information from which emerged the meanings through interpretation. The findings showed that: 1) for teachers there is a clear and definite meaning of Community Nursing and what is expected of students. 2) For the students through the meanings they gave to their own experiences play a dynamic role. However, many of them expressed that they have no vocation for the performance of community service, despite having knowledge in this field and finally 3) for members of the community through the meaning they gave to their experience showed that there are significant changes in the development of activities, but they stated that the values should be strengthened. As final reflections it was revealed that there is a link between the university and the community which is weak in some aspects such as resources, community profile and vocation of the student(AU)

Reflex immunohistochemistry and microsatellite instability testing of colorectal tumors for Lynch syndrome among US cancer programs and follow-up of abnormal results.

PURPOSE: Immunohistochemistry (IHC) for MLH1, MSH2, MSH6, and PMS2 protein expression and microsatellite instability (MSI) are well-established tools to screen for Lynch syndrome (LS). Although many cancer centers have adopted these tools as reflex LS screening after a colorectal cancer diagnosis, the standard of care has not been established, and no formal studies have described this practice in the United States. The purpose of this study was to describe prevalent practices regarding IHC/MSI reflex testing for LS in the United States and the subsequent follow-up of abnormal results. MATERIALS AND METHODS: A 12-item survey was developed after interdisciplinary expert input. A letter of invitation, survey, and online-survey option were sent to a contact at each cancer program. A modified Dillman strategy was used to maximize the response rate. The sample included 39 National Cancer Institute-designated Comprehensive Cancer Centers (NCI-CCCs), 50 randomly selected American College of Surgeons-accredited Community Hospital Comprehensive Cancer Programs (COMPs), and 50 Community Hospital Cancer Programs (CHCPs). RESULTS: The overall response rate was 50%. Seventy-one percent of NCI-CCCs, 36% of COMPs, and 15% of CHCPs were conducting reflex IHC/MSI for LS; 48% of the programs used IHC, 14% of the programs used MSI, and 38% of the programs used both IHC and MSI. One program used a presurgical information packet, four programs offered an opt-out option, and none of the programs required written consent. CONCLUSION: Although most NCI-CCCs use reflex IHC/MSI to screen for LS, this practice is not well-adopted by community hospitals. These findings may indicate an emerging standard of care and diffusion from NCI-CCC to community cancer programs. Our findings also described an important trend away from requiring written patient consent for screening.

Percepción de docentes y alumnos sobre documentos Odontológicos legales utilizados en la práctica clínica de Facultades de Odontología del Paraguay año 2011 / Perception of teachers and students on legal documents used in the Dental Clinical Practice of Dental Schools in Paraguay in 2011

El odontólogo tiene grandes responsabilidades en la sociedad, en función de la misma existen normas éticas y legales que le dan un norte a ese profesional. Todas las actividades odontológicas deben ser plasmadas en documentaciones que son el medio por el cual se demuestra la actuación del mismo. La confección del consentimiento informado es obligatoria según los Códigos Penal y Sanitario y la historia clínica lo es para asegurar una medicina de calidad. El mejor lugar para impartir esta enseñanza es la facultad durante la formación del estudiante. Se evaluó la percepción de docentes y estudiantes sobre documentos odontológicos legales utilizados en la práctica clínica de Facultades del Paraguay con el propósito de tomar medidas correctivas necesarias inculcando el verdadero objetivo de estos documentos en la Institución. Es un estudio observacional descriptivo y componente analítico, se aplicó un cuestionario auto administrado a 233 sujetos. Se observó percepción del 63%; sólo el 3% considera la confección del consentimiento informado como un acto médico y el 92% cree necesario un centro de admisión de pacientes en su Institución. No se observó significancia estadística en relación del tipo de Institución pública o privada y la percepción sobre los documentos odontológicos p= 0,1 p> 0,05

A patient survey assessing the awareness and acceptability of the emergency care summary and its consent model in Scotland.

BACKGROUND: The Emergency Care Summary (ECS) was introduced in 2006 to allow aspects of the general practitioner (GP; family doctor, equivalent to primary care physician) medical record to be viewed in hospitals and out-of-hours centers in Scotland. Records were automatically uploaded unless patients actively opted out. This study investigated patient awareness and acceptance of this process. METHODS: This was a questionnaire survey of patients in a GP surgery (office) in Paisley, Scotland. RESULTS: Survey results indicated that 42 percent of patients were aware of the ECS, and 16 percent said that they recognized the leaflet posted to households. Of those who recognized the leaflet, 92 percent said they were happy for their record to be part of the system, while the others did not realize their record was to be included. Having read the leaflet, 97 percent said that they were happy for their record to be included in the ECS. CONCLUSIONS: This study shows that most patients were not aware of the Emergency Care Summary or did not remember seeing the leaflet posted to households. Having read the leaflet, the vast majority of patients were happy for their records to be included in the system. The low awareness of the ECS calls into question the validity of an implied consent model using an information leaflet distributed by post.