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1.
Determinants of patient participation in clinical studies requiring informed consent: why patients enter a clinical trial 总被引:4,自引:0,他引:4
In a survey on 26 clinical trials we have studied the reasons why some patients choose to participate in clinical trials while others decline. Interviews were held with 198 adult patients, just after they had been asked by the trial-clinician to participate. We interviewed patients who were asked to participate in a clinical trial, including those who decided not to participate. The theoretical guidelines to explain participation were based on an extended form of the Health Belief Model. Patients being asked to participate in a clinical trial decide by making a personal balance account. This comprises the physical and emotional added value patients hope to gain from the trial treatment compared to the non-trial treatment, minus the risks they expect in the trial and minus the extra time they expect the trial will take. The extent they feel physically threatened by their illness will also influence their decision. Furthermore, this personal balance account was found to depend on patient opinion about medical care and care-givers in general and on how patients regard their illness. Relatively long-term patients show a slightly different motivation to participate in a clinical trial than short-term patients. In line with the Health Belief Model, motivational beliefs on the relevance to reducing the threat to the patient's health condition ('values') and the evaluations of the clinical trial the patient is approached for ('expectancy'), are relevant in explaining patient behavior. Moreover, specific evaluative frames of reference are relevant in patients faced with the choice to participate or not. Suggestions are made to improve insight into patient motivation during the informed consent procedure of clinical trials. 相似文献
2.
Introduction
The dynamic development of biobanks causes some ethical, social, and legal problems. The most discussed problems are obtaining informed consent, especially for future research, from minors and from deceased people. The aim of this article is to present the current standards held by Polish biobanks concerning obtaining a participant''s informed consent in some aspects.Material and methods
Survey was carried out by anonymous questionnaire among 59 institutions which deal with the collecting and storage of human cells and tissues in the year 2008. Twenty four filled-in copies of the questionnaires were sent back (return=41%).Results
Almost every institution (92%) obtains written consent, but a third of the surveyed institutions (29%) do not obtain consent for the future use of the samples. The majority of the respondents (83%) support the idea of using biological materials for research purposes of a donor who died if he did not leave any written objection to such practices and 46% of respondents stated that biobanks should obtain the consent from the already mature donor who gave their samples as a child.Conclusions
The practice and rules for obtaining informed consent for the scientific research require improvement. The possibility to use the human materials in the future, conditions for getting access to the data, the possibility of their withdrawal from the database and using the materials and data after the death of the donor should be clearly determined when the informed consent to collect the material is obtained. 相似文献3.
Rajiv Sarkar Thuppal V Sowmyanarayanan Prasanna Samuel Azara S Singh Anuradha Bose Jayaprakash Muliyil Gagandeep Kang 《BMC medical ethics》2010,11(1):8
Background
Studies on different methods to supplement the traditional informed consent process have generated conflicting results. This study was designed to evaluate whether participants who received group counseling prior to administration of informed consent understood the key components of the study and the consent better than those who received individual counseling, based on the hypothesis that group counseling would foster discussion among potential participants and enhance their understanding of the informed consent. 相似文献4.
Objective
To describe relationships between use of the Personal Patient Profile-Prostate (P3P) decision support system and patient characteristics, and perceived preparation for decision making (PrepDM), satisfaction and decisional regret in the context of prostate cancer treatment choice.Methods
494 men with localized prostate cancer (LPC) were randomized to receive the P3P intervention or usual care and completed pre-treatment, 1-month and 6-month outcome measures. Multivariable linear regression models were fit for each outcome.Results
Physician consult visits prior to enrollment, race/ethnicity, and use of clinic-provided books were significant predictors of perceived PrepDM at 1 month. Prior Internet use and PrepDM significantly predicted 6-month decision satisfaction. Decisional regret was significantly predicted by demographics, anxiety, PrepDM score, and EPIC bowel domain score at 6 months. Use of P3P did not predict any outcome.Conclusion
While the P3P intervention did not significantly affect the outcomes, pre-enrollment information and preparation were strong predictors of the 1- and 6-month outcomes. Decision regret was significantly influenced by personal characteristics and post-treatment symptoms/side effects.Practice implications
Information received and used between biopsy and the treatment options consult visit is likely to make a difference in decision satisfaction. 相似文献5.
6.
Randi M. Williams Kimberly M. Davis George Luta Sara N. Edmond Caroline S. Dorfman Marc D. Schwartz John Lynch Chiledum Ahaghotu Kathryn L. Taylor 《Patient education and counseling》2013
Objective
Screening asymptomatic men for prostate cancer is controversial and informed decision making is recommended. Within two prostate cancer screening programs, we evaluated the impact of a print-based decision aid (DA) on decision-making outcomes.Methods
Men (N = 543) were 54.9 (SD = 8.1) years old and 61% were African-American. The 2(booklet type: DA vs. usual care (UC)) × 2(delivery mode: Home vs. Clinic) randomized controlled trial assessed decisional and screening outcomes at baseline, 2-months, and 13-months.Results
Intention-to-treat linear regression analyses using generalized estimating equations revealed that DA participants reported improved knowledge relative to UC (B = .41, p < .05). For decisional conflict, per-protocol analyses revealed a group by time interaction (B = −.69, p < .05), indicating that DA participants were less likely to report decisional conflict at 2-months compared to UC participants (OR = .49, 95% CI: .26–.91, p < .05).Conclusion
This is the first randomized trial to evaluate a DA in the context of free mass screening, a challenging setting in which to make an informed decision. The DA was highly utilized by participants, improved knowledge and reduced decisional conflict.Practice implications
These results are valuable in understanding ways to improve the decisions of men who seek screening and can be easily implemented within many settings. 相似文献7.
8.
9.
Background
Informed consent as stipulated in regulatory human research guidelines requires that a volunteer is well-informed about what will happen to them in a trial. However researchers are faced with a challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. We conducted a qualitative study among volunteers taking part in two HIV clinical trials in Uganda to find out how they defined informed consent and their perceptions of the trial procedures, study information and interactions with the research team.Methods
Between January and December 2012, 23 volunteers who had been in the two trials for over 6 months, consented to be interviewed about their experience in the trial three times over a period of nine months. They also took part in focus group discussions. Themes informed by study research questions and emerging findings were used for content analysis.Results
Volunteers defined the informed consent process in terms of their individual welfare. Only two of the volunteers reported having referred during the trial to the participant information sheets given at the start of the trial. Volunteers remembered the information they had been given at the start of the trial on procedures that involved drawing blood and urine samples but not information about study design and randomisation. Volunteers said that they had understood the purpose of the trial. They said that signing a consent form showed that they had consented to take part in the trial but they also described it as being done to protect the researcher in case a volunteer later experienced side effects.Conclusion
Volunteers pay more attention during the consent process to procedures requiring biological tests than to study design issues. Trust built between volunteers and the research team could enhance the successful conduct of clinical trials by allowing for informal discussions to identify and review volunteers’ perceptions. These results point to the need for researchers to view informed consent as a process rather than an event.10.
11.
Treatment integrity in psychotherapy research: analysis of the studies and examination of the associated factors 总被引:3,自引:0,他引:3
Perepletchikova F Treat TA Kazdin AE 《Journal of consulting and clinical psychology》2007,75(6):829-841
Treatment integrity refers to the degree to which an intervention is delivered as intended. Two studies evaluated the adequacy of treatment integrity procedures (including establishing, assessing, evaluating, and reporting integrity; therapist treatment adherence; and therapist competence) implemented in psychotherapy research, as well as predictors of their implementation. Randomized controlled trials of psychosocial interventions published in 6 influential psychological and psychiatric journals were reviewed and coded for treatment integrity implementation. Results indicate that investigations that systematically addressed treatment integrity procedures are virtually absent in the literature. Treatment integrity was adequately addressed for only 3.50% of the evaluated psychosocial interventions. Journal of publication and treatment approach predicted integrity implementation. Skill-building treatments (e.g., cognitive-behavioral) as compared with non-skill-building interventions (e.g., psychodynamic, nondirective counseling) were implemented with higher attention to integrity procedures. Guidelines for implementation of treatment integrity procedures need to be reevaluated. 相似文献
12.
Choudhary M Haimes E Herbert M Stojkovic M Murdoch AP 《Human reproduction (Oxford, England)》2004,19(9):2091-2096
BACKGROUND: Isolation of human embryonic stem cell lines has opened a promising and pioneering area of basic and applied medical research. The issues in relation to a couples' decision in donating their supernumerary embryos for research need to be investigated further. METHODS: We carried out a prospective study of 300 couples who underwent IVF/ICSI treatment cycles in our unit. We analysed various factors contributing to their decision to consent to donate spare embryos for stem cell or preimplantation genetic diagnosis research. RESULTS: The majority of couples (54%) consented to donate their surplus embryos for research. Couples of ethnic minority origin were less willing to consent for research compared to Caucasian couples. The number of ovarian follicles at pre-hCG scan and the number of embryos obtained were significantly higher in couples consenting for research. The funding source of treatment did not appear to influence the decision to donate. Couples with previous failed fertilization were less likely to consent to embryo research. CONCLUSIONS: Physical characteristics based on ovarian response during a treatment cycle may positively influence a couple's decision to donate embryos. Further studies are needed to identify those couples who are likely to agree to research so that counselling for research can be directed efficiently. 相似文献
13.
The self-help movement in Hong Kong has been gradually gaining its momentum in recent years. The primary purpose of the research was to give voice to the experiences and views of patients towards cancer care and to influence healthcare providers and policy makers to act on patients' agendas. Self-help groups and their members are mobilized through the research activities of focus groups, interviews and a patient forum to specify and act on their needs. This article describes the project and the participatory action research (PAR) strategies in the mobilization of, and collaboration with, patient groups in research design, data analysis, and dissemination of findings. The implications on healthcare practice, particularly within an era of reform and restructuring of the healthcare system, are discussed. 相似文献
14.
The clinical evaluation of capacity to consent to treatment occurs in the medical setting and is based on legal foundations of informed consent and capacity. Clinical judgment is still the "gold standard" for capacity determination, although it can be unreliable. In the past 10 years the empirical basis for these assessments has been advanced considerably by the introduction of a number of instruments designed to assess capacity to consent to treatment. In this paper, we review studies, mostly with older adult populations, that consider the cognitive and non-cognitive correlates of consent capacity, rates of impaired capacity in various patient groups, the relation of instrument-based to clinician-based capacity assessment, and the inter-rater and test-retest reliability of consent capacity assessment. We also overview key research focusing on factors influencing, and procedural and processing variables involved in, medical decision-making. We conclude that these studies have yielded quite varied results, and promote no consensus regarding the reliability and validity of instrument-based consent capacity assessment. Overall, the results of these studies provide some guidance for clinicians, but, at present, practitioners should view these instruments as supplemental resources rather than benchmarks for assessment. However, this first generation of instruments provides a good foundation for future research, which should continue to systematically study aspects of reliability and validity, most especially construct validity, in well-defined patient populations. 相似文献
15.
A.M. Willis S.K. Smith B. Meiser M.L. Ballinger D.M. Thomas M.‐A. Young 《Clinical genetics》2017,92(2):121-133
Evidence suggests that a significant proportion of individuals referred to cancer genetic counselling (GC) do not attend, and thus may not be engaged in adequate cancer risk management. We aimed to review the literature to better understand barriers to accessing GC and how they may be overcome. We conducted a systematic literature search for articles examining factors influencing cancer GC uptake as well as motivators and barriers to GC attendance. Factors were categorised as sociodemographic, psychosocial or clinical. The literature search identified 1413 citations, 35 of which met the inclusion criteria. GC uptake ranged from 19% to 88%. With the exceptions of education level, socioeconomic status, cancer‐specific distress, personal cancer diagnosis and actual and perceived risk of cancer, support was lacking for most sociodemographic, clinical and psychosocial factors as predictors of GC uptake. Cost and logistical barriers, emotional concerns, family concerns and low perceived personal relevance were reported as important considerations for those declining GC. We conclude that there is poor understanding of GC and a lack of decision support among those referred to GC. Research into ways of providing education and support to referred individuals will be important as the scope and availability of GC and genetic testing broaden. 相似文献
16.
Maarten Cuypers Romy E.D. Lamers Paul J.M. Kil Lonneke V. van de Poll-Franse Marieke de Vries 《Patient education and counseling》2019,102(3):424-428
Objective
To investigate the effect of including an online decision aid (DA) during prostate cancer treatment counseling on decisional regret and information satisfaction in a one-year follow-up.Methods
Within a cluster RCT, 18 Dutch hospitals were randomized to DA counseling or care-as-usual, patients (n?=?382) initially completed questionnaires directly after treatment decision making. Six and twelve months later regret (Decisional Regret Scale) and information satisfaction (SCIP-B) were assessed. Anxious and depressive symptoms (HADS) was included as possible covariate.Results
After 12 months, 43 participants (15%) regretted their treatment choice and 105 participants (36%) were dissatisfied with the information that was received at the time of decision-making, regardless of being exposed to the DA. Anxious and depressive symptoms at follow-up were associated with regret and information dissatisfaction.Conclusion
No long-term benefical effects emerged from DA usage compared to patients who underwent standard counseling.Practice implications
During PCa treatment counseling, healthcare providers should be aware of anxious and depressive symptoms. 相似文献17.
A proposal for a model of informed consent for the collection, storage and use of biological materials for research purposes 总被引:1,自引:0,他引:1
OBJECTIVE: To suggest a model of informed consent for the collection, storage and use of biological materials in local biobanks for health research purposes. METHODS: Review of the major ethical issues related to collection, storage and use of human biological materials for research purposes. RESULTS: An informed consent form for the collection and use of biological materials in a specific research project, and an informed consent form for the collection, storage and use of biological materials in a biobank were separately developed. Two main rules govern the proposed model, as follows: the informed consent for the use of biological materials shall (i) give donors sufficient information to take informed decisions about possible present and future uses of their biological materials and (ii) consider the specific biological and genetic aims of the research being performed. CONCLUSION: Even if informed consent for the collection, storage and use of biological materials is a hard process, donors can actually be provided with sufficient information and choices to give a 'really informed consent'. PRACTICE IMPLICATIONS: The proposed model can be a useful guideline for the development of specific informed consent forms to be used by researchers. It can also be a good tool to let the donors know which information and guarantees they can request from researchers. 相似文献
18.
Sylvester C Chima 《BMC medical ethics》2013,14(Z1):S3
Background
Informed consent is a legal and ethical doctrine derived from the principle of respect for autonomy. Generally two rights derived from autonomy are accorded legal protection. The constitutional right to bodily integrity followed by the right to bodily well-being, protected by professional negligence rules. Therefore healthcare professionals treating patients' without valid consent may be guilty of infringing patients' rights. Many challenges are experienced by doctors obtaining informed consent in complex multicultural societies like South Africa. These include different cultural ethos, multilingualism, poverty, education, unfamiliarity with libertarian rights based autonomy, and power asymmetry between doctors and patients. All of which could impact on the ability of doctors to obtain legally valid informed consent.Methods
The objective of this study was to evaluate whether the quality of informed consent obtained by doctors practicing in South Africa is consistent with international ethical standards and local regulations. Responses from 946 participants including doctors, nurses and patients was analyzed, using a semi-structured self-administered questionnaire and person triangulation in selected public hospitals in Durban, KwaZulu-Natal, South Africa.Results
The median age of 168 doctors participating was 30 years with 51% females, 28% interns, 16% medical officers, 26% registrars, 30% consultant/specialists. A broad range of clinical specialties were represented. Challenges to informed consent practice include language difficulties, lack of interpreters, workload, and time constraints. Doctors spent 5-10 minutes on consent, disclosed most information required to patients, however knowledge of essential local laws was inadequate. Informed consent aggregate scores (ICAS) showed that interns/registrars scored lower than consultants/specialists. ICAS scores were statistically significant by specialty (p = 0.005), with radiologists and anaesthetists scoring lowest, while internists, GPs and obstetricians/gynaecologists scored highest. Comparative ICAS scores showed that professional nurses scored significantly lower than doctors (p ≤ 0.001).Conclusions
This study shows that though doctors had general knowledge of informed consent requirements, execution in practice was inadequate, with deficiency in knowledge of basic local laws and regulations. Remedying identified deficiencies may require a 'corps' of interpreters in local hospitals to assist doctors in dealing with language difficulties, and continuing education in medical law and ethics to improve informed consent practices and overall quality of healthcare service delivery.19.
Godard B Schmidtke J Cassiman JJ Aymé S 《European journal of human genetics : EJHG》2003,11(Z2):S88-122
The purpose of this paper is to formulate a professional and scientific view on the social, ethical, and legal issues that impact on data storage and DNA banking practices for biomedical research in Europe. Many aspects have been considered, such as the requirements for data storage and DNA banking in the public and private sectors in Europe and the issues relating to DNA banking, that is to say the consent requirements for the banking and further uses of DNA samples, their control and ownership, and the return of benefit derived from DNA exploitation to the community. The methods comprise primarily the review of the existing professional guidelines, legal frameworks and other documents related to the data storage and DNA banking practices in public and private sectors in Europe. Then, the issues related to DNA banking were examined during an international workshop organized by the European Society of Human Genetics Public and Professional Policy Committee in Paris, France, 07-08, April, 2000. A total of 50 experts from 12 European countries attended this workshop. It came out that DNA banking for medical and research purposes is indispensable. It facilitates the constitution of large collections, sharing of samples, multiple testing on the same samples, and repeating testing over the years. However, banking organization is complex, requires multiple actors, and concerns are expressed in various countries. International standardization of ethical requirements and policies with regard to DNA banking has been recommended. Such standardization would facilitate a greater protection of individuals as well as future international cooperation in biomedical research. 相似文献
20.
《Patient education and counseling》2017,100(3):550-562
ObjectiveWe aimed to evaluate the effect of a decision aid (DA) with patient narratives on decisional conflict in surgery choice for Japanese women with early-stage breast cancer.MethodsTwo hundred ten women with early-stage breast cancer were randomly assigned to an intervention or control group. Groups 1 and 2 received standard information and a DA, with or without patient narratives, and Group 3 received standard information (control) before surgery choice. At baseline, post-intervention (Time 2), and 1 month after surgery (Time 3), we evaluated decisional conflict as the primary outcome using a decisional conflict scale (DCS). Sidak corrections for multiple comparisons in analysis of covariate were used to compare Time 2 and Time 3 DCS mean scores between each pair of groups.ResultsAt Time 3, decisional conflict was significantly reduced for Group 1 vs control (P = 0.021, Cohen’s d = 0.26) and Group 2 vs control (P = 0.008, Cohen’s d = 0.40).ConclusionThe DAs with and without patient narratives are equivalently effective at reducing postoperative decisional conflict in Japanese women with early-stage breast cancer.Practice implicationsThe DAs with and without patient narratives can be used in clinical practice for women with early-stage breast cancer. 相似文献