Self-reported emotional and behavioral problems in Nepalese adolescents from urban and rural areas.

In this study, the prevalence of self-reported emotional/behavioral problems and the association of problem scales scores with demographic factors among 12-18 year old adolescents (n = 408) selected from urban and rural areas of the Western Developmental Region of Nepal, are discussed. The emotional/behavioral problems were assessed by the Youth Self-Report questionnaire. Girls had higher scores than boys for anxiety/depression, while boys had higher scores for delinquent behavior. Adolescents from the urban area exhibited significantly higher scores on most of the problem scales. With the exception of somatic complaints, all problem scale scores appeared to increase with age. Most of the Youth Self-Report scales revealed adequate internal consistencies. These findings might provide preliminary information on adolescents' emotional/behavioral problems. However, a detailed and comprehensive study is needed before an effective interventional program can be implemented. Further investigation, particularly taking into account the views of parents and teachers, is also needed, as this would provide novel perspectives on adolescents' problems.

Examination of the phases of metasynthesis: a study on patients' duties as an example.

In recent years, the use of metasynthesis as a research method has increased within nursing science. In the present paper, we focus on examining the phases of metasynthesis, using a study of patients' duties as an example. The aim of this paper is to increase the understanding of synthesis as a method in order to promote research trustworthiness by making the research process more transparent and thereby increasing the readers' awareness of it. We formulated a purpose for each phase of metasynthesis in order to better understand synthesis as a rational thinking process. We found that the collaboration of several researchers during all phases of metasynthesis is needed in order to maintain research ethics and trustworthiness. In addition, further study of the phases of metasynthesis is needed for improving research methods in order to produce new, accumulated knowledge based on previous qualitative study.

Duties of the patient: a tentative model based on metasynthesis.

Patient's duties are a topical but little researched area in nursing ethics. However, patient's duties are closely connected to nursing practice in terms of autonomy, the best purpose of care and rethinking from the patient's perspective. This article is a metasynthesis (N = 11 original articles) of patient's duties, aimed to create a tentative model. In this article, a tentative model called 'right-based duties of a patient' was constructed. With its aid, a coherent structure of patient's duties within different roles and objects of a patient can be defined. In addition, the ethical basis, prerequisites, outcomes and risks of patient's duties can be named. In conclusion, so-called right-based duties of a patient constitute the basic argument. Patient's duties are not unambiguous for all patients, and the global perspective to duties has been challenged. However, due to both conceptual and practical reasons, rethinking of patient's duties is needed.

Is informed consent related to success in exercise and diet intervention as evaluated at 12 months? DR's EXTRA study.

BACKGROUND: There is a permanent need to evaluate and develop the ethical quality of scientific research and to widen knowledge about the effects of ethical issues. Therefore we evaluated whether informed consent is related to implementation and success in a lifestyle intervention study with older research participants. There is little empirical research into this topic. METHODS: The subjects (n = 597) are a subgroup of a random population sample of 1410 men and women aged 57-78 years who are participating in a 4-year randomized controlled intervention trial on the effects of physical exercise and diet on atherosclerosis, endothelial function and cognition. Data were collected in two steps: A questionnaire about informed consent was given to all willing participants (n = 1324) three months after the randomization. Data on implementation and success in the exercise and diet interventions were evaluated at 12 months by intervention-group personnel. The main purpose of the analysis procedure performed in this study was to identify and examine potential correlates for the chosen dependent variables and to generate future hypotheses for testing and confirming the independent determinants for implementation and success. The nature of the analysis protocol is exploratory at this stage. RESULTS: About half of the participants (54%) had achieved good results in the intervention. Nearly half of the participants (47%) had added to or improved their own activity in some sector of exercise or diet. Significant associations were found between performance in the interventions and participants' knowledge of the purpose of the study (p < 0.001), and between success in interventions and working status (p = 0.02), and the participants' knowledge of the purpose of the study (p = 0.04). CONCLUSION: The main finding of this study was that those participants who were most aware or had understood the purpose of the study at an early stage had also attained better results at their 12-month intervention evaluation. Therefore, implementation and success in intervention is related to whether subjects receive a sufficient amount and are able to comprehend the information provided i.e. the core principles of informed consent. TRIAL REGISTRATION: (ISRCTN 45977199).

Evaluation of participant comprehension of information received in an exercise and diet intervention trial: The DR's EXTRA study.

BACKGROUND: The informed consent process is the legal and ethical cornerstone of health research and is essential to ensure that participants in health research really understand the information they receive. Clinical studies often fail to provide data that clarify how much participants have understood. OBJECTIVE: To evaluate the comprehension of older volunteer participants in health research. METHODS: The subjects are a random population sample of 1,410 men and women aged 57-78 years, who are participating in a 4-year randomized controlled intervention trial on the effects of physical exercise and diet on atherosclerosis, endothelial function and cognition. A questionnaire about informed consent was given to all willing participants (n = 1,324) 3 months after the randomization. In addition, participants' long-term continuation in the intervention trial with relation to understanding was evaluated 2 years after the randomization. RESULTS: The response rate was 91%. The majority of respondents (89%) were satisfied with the intelligibility of received information. In addition, the participants' comprehension of the information received seemed to be adequate in 82% of the whole study population. Compared to background variables, higher education (p < 0.001) and satisfaction with one's own health (p = 0.01) were associated with adequate comprehension of the provided information. Furthermore, participants who felt themselves to be healthy were more likely to continue participating in the intervention after 2 years. CONCLUSIONS: The findings of this study indicated sufficient understanding of received information in older research participants. However, our results indicate that special efforts should be made with participants with lower educational levels or subjective feelings of impaired health. This study highlights the need for researchers to critically analyze the quality of information and how it is provided. This is especially important in long-term follow-up studies.

Evaluation of informed consent in health research: a questionnaire survey.

OBJECTIVE: Informed consent is ethically and legally required for all biomedical and health research involving human participants. This study analyses the realization of informed consent in health research from the point of view of healthy, voluntary adult participants. Empirical studies from this point of view are still rare. DESIGN: A population-based questionnaire survey. PARTICIPANTS: The study population consisted of 1410 men and women aged 57-78 years who are participants in a randomized controlled intervention trial on the effects of physical exercise and diet at Kuopio Research Institute of Exercise Medicine (eastern Finland). METHODS: The data were collected in 2005-2007 using a questionnaire. The questionnaire was given to all able and willing participants (n = 1324) who were still involved in the exercise and diet study at the 3-month intervention visit. The response rate was 91%. RESULTS: The defined key elements of informed consent were information, understanding, competence, voluntariness and decision-making. A majority of the participants estimated that these key elements were successfully realized in the exercise and diet intervention study. CONCLUSIONS: Despite the general satisfaction with the informed consent process in the exercise and diet intervention study, a minority of the participants were dissatisfied with the information they had received or did not understand this information completely. These findings highlight the essential question: Did all of the participants truly give their genuine informed consent? This carefully executed study reveals objectively the difficulties in distribution of information to healthy adult volunteers.

Evaluation of informed consent: a pilot study.

AIM: This paper is a report of a study to describe and analyse the use of informed consent in clinical research, from the point of view of voluntary adult research participants, in order to develop and test an interview schedule for the evaluation of informed consent. BACKGROUND: Informed consent is one of the central ethical research principles in healthcare research, but empirical research on this topic is still scarce. To evaluate and develop the ethical quality of scientific research, there is a need to explore the meaning and implications of informed consent for research participants. METHOD: The data were collected in 2004 by interviews using an interview schedule created for this study by the first author and discussed in a multidisciplinary group. The response rate was 81%. The sample consisted of 32 patients with a metabolic syndrome who were participants in a project evaluating the effects of betaine on cardiovascular risk factors. FINDINGS: Participants stated that the key elements of informed consent are information, understanding and decision-making, and that competence is an essential factor in the reception and understanding of information and making an independent decision about participation. Our interview schedule was found to be useful in the investigation of informed consent. CONCLUSION: This study strengthened the perception that more extensive research about research participants is needed.