Patients' perceptions of physicians communication and outcomes of the accrual to trial process

The purpose of this study was to examine the relations among patients' perceptions of their physicians' communicative behavior during the informed consent interview, the patient's feeling of being confirmed by the physician and satisfied with care delivered by the physician, and the patient's decision to participate in a clinical trial or not. Respondents included 130 cancer patients who were eligible for a clinical trial and who had recently discussed trial participation with their physicians. Results indicated that a linear combination of the variables physician affiliative style, physician dominant or controlling style, patient satisfaction, patient confirmation, patient preference for decision making, patient desire for information, and patient age discriminate between patients who agree to participate in clinical trials and patients who refuse to participate. Physicians' affiliative communicative behaviors and patient satisfaction were clearly important to patients who agreed to participate. Motivations for patients who declined to participate in trials were less clear. Implications for physicians who offer clinical trials to their patients are that specific communication skills may enhance their patients' satisfaction and may help increase enrollment in clinical trials.     

Informed consent in clinical trials

A review is provided in this paper on the empirical literature on informed consent from 1979 to 1995 referring to information disclosure and trial participation in clinical trials. Articles being reviewed focus upon information disclosure, reactions to disclosure and recall, features of consent and perceptions of informed consent, both in hypothetical and in real life situations. It is concluded that further research is needed to study the process of informed consent in clinical trials, to obtain a better insight into the myth and reality of informed consent in daily practice. Future studies should come forward on the limitations of previous empirical research on informed consent. Additional research should focus on the perspectives of patients who accept or decline trial participation.     

Informed consent in China: quality of information provided to participants in a research project

AIMS: A study was carried out of informed consent strategies in an epidemiological project approved by the regional research ethics committees in Sweden and China and conducted in three areas south-west of Shanghai. METHODS: All participants in the epidemiological project (EP) were included in the research ethical study (RES), which was conducted as a questionnaire-based interview survey in the three areas. Answers were collected by five field interviewers. RESULTS: All participants included answered the questionnaire. Almost all perceived the information provided as rather good or quite good. However, a majority (on average 76%) had the impression that the EP was part of routine healthcare measures, and not a research project. Almost all participants felt free to abstain from participation although 38% in area II stated that they had not been informed about freedom to abstain from participation. A large proportion of participants did not fully understand the nature of the EP. However, almost all participants stated that they would agree to participate in a similar study in the future. CONCLUSION: Although informed consent procedures are supposed to be internationally applicable our study illustrates that it is not always easy to convey information and obtain consent in the present study setting.     

Trusting technology: women aged 40-49 years participating in screening for breast cancer--an exploratory study

OBJECTIVE: This paper reports key findings from an exploratory study of factors associated with women's decision to participate in mass mammography screening in Tasmania. In particular, we explored factors that contribute to the choice to participate in screening by women who are outside the primary target group, and for whom the evidence of benefit remains contentious. METHODS: Semi-structured interviews were conducted with a small sample of women aged between 40 and 49 years in rural Tasmania who had participated in mammography screening. RESULTS: Key ideas that appeared to shape participation included the fear of breast cancer, trust in technology, and taking responsibility for health. Information provision is also an important factor in shaping participation patterns. CONCLUSIONS AND IMPLICATIONS: In order to facilitate informed consent, information provision in this area should take account of the dominant ideas that shape the decision to participate in breast cancer screening.     

Trials and tribulations: understanding motivations for clinical research participation amongst adults with cystic fibrosis

In the context of understanding motivations for clinical research participation, many authors consider issues such as informed consent and how patients perceive the research method and process. However, many investigations focus only on one method of research, most commonly the randomised controlled trial. Understanding how chronically ill members of one specific patient group respond to all requests for research participation are rare. Cystic fibrosis (CF), a genetic condition whereby those affected are used to taking a wide array of treatments and attending a specialist care centre over many years, and are generally knowledgeable about their condition, represents an ideal case for investigating how staff requests for clinical research participation are accepted or declined. Using Bloor's systems of relevance framework for risk behaviour and risk reduction, specialist CF centre patients' motivations for participation or non-participation in clinical research can be understood. The framework takes into account two sets of conceptual oppositions: habituation and calculation, constraint and volition. These oppositions represent a range along a continuum of risk behaviour rather than being absolute distinctions. Decisions to participate are influenced mainly by the patient's state of health at the time of request, the nature of the trial and the social context within which sufferers are placed. Understanding why chronically ill patients refuse some requests and yet accept others may assist researchers in designing protocols that take these factors into account and achieve the desired numbers of participants whilst protecting those in vulnerable positions.     

An analysis of factors that predict patient consent to take part in a randomized controlled trial

BACKGROUND: Recruitment targets of patients to multi-centre primary care-based randomized controlled trials (RCT) are often not met. A critical step in the pathway is whether an eligible patient will give consent. OBJECTIVE: To assess whether patient, practice or practitioner characteristics are associated with a patient's likelihood of giving consent to participation in a large primary care-based RCT. METHODS: A cross-sectional study of patients from 260 practices in England and Wales who met the eligibility criteria for an RCT of aspirin versus warfarin for stroke prevention and attended an appointment with their GP to consider trial participation. Logistic regression analysis was used to determine which patient and practitioner factors independently predicted whether or not a patient would give consent to take part in the trial. RESULTS: Of the 1740 patients, 973 (55.9%) gave consent. On multivariable analysis, patient factors associated with increased likelihood of giving consent were younger age, current use of warfarin and year of recruitment to the trial. Patients with a history of transient ischaemic attack, angina or valve disease were less likely to give consent. Practice/practitioner factors that were associated with increased likelihood of consent were smaller practice size (practices with greater than eight GPs as compared with those with one to two GPs, odds ratio 0.40, 95% confidence interval 0.21-0.75) and older GPs. CONCLUSIONS: The strong association of consent with year of recruitment may be due to changes in trial procedures and investigator training. If so, this has important implications for the conduct of future trials.     

Patients' perceptions of informed consent in acute myocardial infarction research: a Danish study

Seeking informed consent from patients in the acute phase of acute myocardial infarction (AMI) poses an ethical challenge due to the fact that these patients are under stress and require urgent medical attention. The very procedure of informed consent, which is supposed to protect eligible patients, may in fact cause harm due to a potential delay in the provision of therapy. Whether or not informed consent can and should be obtained under these particular circumstances is far from evident. Patients participating in various large-scale AMI trials have been enrolled with, as well as without, informed consent in recent years. Little is known, however, about how patients experience the informed consent process in the emergency situation of an AMI. This paper reports the results from qualitative interviews with 32 patients, who had to decide whether or not to participate in a large multi-centre clinical trial in Denmark. We analyse to what extent patients found the informed consent process acceptable as well as how various factors influenced their experience of the consent process. We argue that it is morally sound to involve those patients in a brief and concise informed consent process and that consent should be sought in such trials. Finally, we discuss how future AMI trials may nonetheless be improved by accommodating some of the concerns of the patients.     

Adolescent decision making about participation in a hypothetical HIV vaccine trial

PurposeThe purpose of this study was to examine the process of adolescent decision-making about participation in an HIV vaccine clinical trial, comparing it to adult models of informed consent with attention to developmental differences.MethodsAs part of a larger study of preventive misconception in adolescent HIV vaccine trials, we interviewed 33 male and female 16–19-year-olds who have sex with men. Participants underwent a simulated HIV vaccine trial consent process, and then completed a semistructured interview about their decision making process when deciding whether or not to enroll in and HIV vaccine trial. An ethnographic content analysis approach was utilized.ResultsTwelve concepts related to adolescents’ decision-making about participation in an HIV vaccine trial were identified and mapped onto Appelbaum and Grisso's four components of decision making capacity including understanding of vaccines and how they work, the purpose of the study, trial procedures, and perceived trial risks and benefits, an appreciation of their own situation, the discussion and weighing of risks and benefits, discussing the need to consult with others about participation, motivations for participation, and their choice to participate.ConclusionThe results of this study suggest that most adolescents at high risk for HIV demonstrate the key abilities needed to make meaningful decisions about HIV vaccine clinical trial participation.     

Barriers to participation in randomised controlled trials: a systematic review

Method: A systematic review of three bibliographic databases from 1986 to 1996 identified 78 papers reporting barriers to recruitment of clinicians and patients to randomised controlled trials. Results: Clinician barriers included: time constraints, lack of staff and training, worry about the impact on the doctor-patient relationship, concern for patients, loss of professional autonomy, difficulty with the consent procedure, lack of rewards and recognition, and an insufficiently interesting question. Patient barriers included: additional demands of the trial, patient preferences, worry caused by uncertainty, and concerns about information and consent. Conclusions: To overcome barriers to clinician recruitment, the trial should address an important research question and the protocol and data collection should be as straightforward as possible. The demands on clinicians and patients should be kept to a minimum. Dedicated research staff may be required to support clinical staff and patients. The recruitment aspects of a randomised controlled trial should be carefully planned and piloted. Further work is needed to quantify the extent of problems associated with clinician and patient participation, and proper evaluation is required of strategies to overcome barriers.     

The role of social work in HIV/AIDS clinical trials.

The social worker can facilitate screening, retention and patient adherence in HIV/AIDS clinical trials. This paper introduces the process and its key vocabulary, and uses three case studies to demonstrate how social workers can assist clients who may wish to participate in, or are already enrolled in a clinical trial. After examining five major issues that affect the client in a clinical trial (informed consent; treatment vs. research; risks and side effects; altruism; the role of family members; and gender, race and class issues), the authors elaborate on interventions at the screening level, and concrete services and psychosocial interventions for study participants.     

The impact of HIPAA authorization on willingness to participate in clinical research

PURPOSE: This study systematically examined the impact of inclusion of Health Insurance Portability and Accountability Act (HIPAA) authorization on the willingness of African Americans of diverse sociodemographic characteristics to participate in a clinical research study and explored reasons for nonparticipation. METHODS: For a purposive sample of 384 African American outpatients at four metropolitan primary care clinics from August 2005 through May 2006, willingness to participate in a hypothetic clinical research study of an antihypertensive medication under one of two experimental conditions was compared. Interviewees were randomly assigned to undergo informed consent alone (control group) or informed consent with HIPAA authorization (HIPAA group). They were asked whether they would participate and reasons for their decisions. RESULTS: A smaller proportion of interviewees in the HIPAA group were willing to enroll in the study (27% vs. 39%; p = 0.02), with an adjusted odds ratio of 0.56 (95% confidence interval = 0.36-0.91). Those in the HIPAA group were more likely to give reasons related to privacy (p < 0.001), poor understanding of the form (p = 0.01), and mistrust or fear of research (p = 0.04) for nonparticipation. CONCLUSIONS: The inclusion of HIPAA authorization within the informed consent process may adversely affect the willingness of African Americans to participate in clinical research and may raise concerns about privacy, understanding the forms, and mistrust or fear of research.     

Improving informed consent: pilot of a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II DCIS)

Background  Patients and clinicians report difficulties with the process of informed consent to clinical trials and audiotape audits show that critical information is often omitted or poorly presented. Decision aids (DAs) may assist in improving consent.
Aims  This study piloted a DA booklet for a high priority breast cancer prevention trial, IBIS-II DCIS, which compares the efficacy of an aromatase inhibitor (anastrozole) with tamoxifen in women who have had surgery for ductal carcinoma in situ (DCIS).
Method  Thirty-one Australian women participating in the IBIS-I breast cancer prevention trial and who are currently in follow-up agreed to read the IBIS-II DCIS participant information sheet and the DCIS DA booklet, complete a set of standardized questionnaires, and provide feedback on the DA via a semi-structured phone interview.
Results  Women found the DA helpful in deciding about trial participation, reporting that it aided their understanding over and above the approved IBIS-II DCIS participant information sheet and was not anxiety provoking. Women's understanding of the rationale and methods of clinical trials and the IBIS-II DCIS trial was very good; with more than 80% of items answered correctly. The only areas that were not understood well were the concepts of randomization and blinding.
Conclusions  This study suggests that the DA will be acceptable to and valued by potential participants in the IBIS-II DCIS study. The revised DA is currently being evaluated prospectively in a randomized controlled trial. If successful, such DAs could transform the consent process to large clinical trials and may also reduce dropout rates.     

Barriers to Cancer Clinical Trial Participation Among American Indian and Alaska Native Tribal College Students

Purpose: American Indians and Alaska Natives (AIs/ANs) have some of the highest cancer‐related mortality rates of all US racial and ethnic groups, but they are underrepresented in clinical trials. We sought to identify factors that influence willingness to participate in cancer clinical trials among AI/AN tribal college students, and to compare attitudes toward clinical trial participation among these students with attitudes among older AI/AN adults. Methods: Questionnaire data from 489 AI/AN tribal college students were collected and analyzed along with previously collected data from 112 older AI/AN adults. We examined 10 factors that influenced participation in the tribal college sample, and using chi‐square analysis and these 10 factors, we compared attitudes toward research participation among 3 groups defined by age: students younger than 40, students 40 and older, and nonstudent adults 40 and older. Findings: About 80% of students were willing to participate if the study would lead to new treatments or help others with cancer in their community, the study doctor had experience treating AI/AN patients, and they received payment. Older nonstudent adults were less likely to participate on the basis of the doctor's expertise than were students (73% vs 84%, P = .007), or if the study was conducted 50 miles away (24% vs 41%, P= .001). Conclusions: Finding high rates of willingness to participate is an important first step in increasing participation of AIs/ANs in clinical trials. More information is needed on whether these attitudes influence actual behavior when opportunities to participate become available.     

Informed consent by children and participation in an influenza vaccine trial.

Two hundred thirteen school children, ages six to nine, were presented the opportunity to participate in an experimental trial of swine influenza vaccine. In non-directive question and answer sessions, all groups of children except one composed only of six year olds elicited all relevant information on the details of the trial and the associated risks and benefits. Forty-six per cent of the subjects declined to participate. Letters requiring informed consent of the parents were sent to the homes of the others. Almost 15 per cent of these parents agreed to their children's participation. In this setting, children initiate their own visits to the school nurse practitioner. A significant association was found between volunteering for the study and higher use of services (but not for medical reasons). Younger children and boys, regardless of their patterns of use, were less inclined to volunteer for the experiment.     

A brief measure of perceived understanding of informed consent in a clinical trial was validated

BACKGROUND AND OBJECTIVE: To develop and evaluate an Informed Consent Questionnaire (ICQ) for measuring self-reported perceived understanding of informed consent in a randomized clinical trial. METHODS: The study was embedded in a Department of Veterans Affairs randomized clinical trial of Gulf War veterans' illnesses (CSP#470). The trial was initiated in May 1999 at 20 hospitals and concluded in September 2001; 1,092 participants were enrolled and followed for 12 months. The reliability and validity sample included 1,086 participants evaluated at baseline, 906 at 3 months, 929 at 6 months, and 910 at 12 months. The psychometric evaluations included tests of acceptability (based on missing data, endorsement frequencies, and floor/ceiling effects), item reduction, internal consistency, and construct validity (based on Cronbach's alpha coefficients, item-total correlations, and principal components analysis). RESULTS: The ICQ had >5% missing information on some questions at baseline, indicating poor acceptability prior to the initiation of the trial; however, the scale had good acceptability at each of the follow-up visits. Psychometric evaluation following standard item reduction techniques confirmed the reliability and validity of a four-item subscale of the ICQ (ICQ-4). CONCLUSIONS: The ICQ-4 is a simple and psychometrically sound self-report measure of perceived understanding of informed consent.     

Why are patients in clinical trials of heart failure not like those we see in everyday practice?

BACKGROUND/OBJECTIVES: Evidence-based research has been criticized for not being relevant to the real world of patient care in the community, mainly because participants in research studies are dissimilar to those typically seen in every day practice. This article examines recruitment difficulties, and identifies the main reasons why patients with heart failure declined to participate in a research trial. METHODS: Postal survey of potential trial participants (n=667), at time of recruitment. Analysis of (1) clinical and sociodemographic characteristics of respondents and nonrespondents to survey, and decliners and consenters to participation in a randomized controlled trial. RESULTS: No significant differences were found between respondents and nonrespondents in respect to sociodemographic or clinical variables. Males (OR=1.58, CI=1.04-2.41), younger patients (OR=1.05, CI=1.03-1.08), and those prescribed an angiotensin converting enzyme (ACE) inhibitor (OR=1.68, CI=1.10-2.57) were significantly more likely to consent to participate. Main reasons for nonparticipation were perceptions of being too old, too unwell, or too busy. CONCLUSIONS: Explanations of the purpose of research need to counter against perceptions among participants and clarify the benefits and disadvantages of participating in an intervention study when unwell. Study design should recognize that many elderly patients have busy lives and caring responsibilities. Financial support for participation should be considered.