A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials. An educational video to increase clinical trials enrollment among lung cancer patients. An educational video to increase clinical trials enrollment among breast cancer patients. Standardized audiotape versus recorded consultation to enhance informed consent to a clinical trial in breast oncology. Educational workshop improved information-seeking skills, knowledge, attitudes and the search outcome of hospital clinicians: a randomised controlled trial. Randomized trial of psychotropic medication information leaflets for people with intellectual disability. Presenting clinical trial information: a comparison of methods. A randomized trial of a computerized versus an audio-booklet decision aid for women considering post-menopausal hormone replacement therapy. The end-of-study patient survey: methods influencing response rate in the AVID Trial.
Recruitment to cancer clinical trials needs to be improved, as does patient knowledge and understanding about clinical trials, in order for patients to make an informed choice about whether or not to take part. Audiovisual patient information (AVPI) has been shown to improve knowledge and understanding in various areas of practice, but there is limited information about its effect in the cancer clinical trial setting, particularly in relation to consent rates. In this study, 173 patients were randomised to receive either the AVPI, in addition to the standard trial-specific written information, or the written information alone. There was no difference in clinical trial recruitment rates between the two groups with similar study entry rates: 72.1% in the AVPI group and 75.9% in the standard information group. The estimated odds ratio for refusal (intervention/no intervention) was 1.19 (95% CI 0.55-2.58, P=0.661). Knowledge scores increased more in the AVPI group compared to the standard group (P=0.0072). The change in anxiety score between the arms was also statistically significant (P=0.011) with anxiety improving in the intervention arm more than in the no intervention arm. Audiovisual patient information was shown to be a useful tool in improving patient knowledge and anxiety, but further work is necessary in relation to its effect on clinical trial recruitment rates. Only 3 to 5% of new adult cancer patients participate in clinical trials nationwide. The lack of knowledge and awareness about clinical trials is a significant barrier to clinical trials participation. A randomized trial was conducted to test the effect of an educational video on positively changing patients' knowledge and attitudes regarding clinical trials and thereby increasing enrollment rates.
                Lung cancer patients were randomized to viewing either an 18-minute video about clinical trials before first clinic appointment or to standard care. Participants completed a baseline and 2-week postintervention survey to assess their knowledge and attitudes toward trials participation. Fisher's exact test tests, t tests, and regression were used to compare patient characteristics and outcomes between arms.
                Of 145 subjects randomized, 126 (63/arm) satisfied all inclusion criteria and were included in the analysis. A linear regression showed that the video intervention was significantly associated with patients' self-assessed likelihood to enroll score measured at 2-week follow-up (p = 0.019). Although statistically insignificant, enrollment rates were found to be higher in the intervention arm for therapeutic trials alone (17.5% versus 11.1%) and for therapeutic and nontherapeutic trials combined (25.4% versus 15.9%).
                The brief educational video seems to be effective in positively changing lung cancer patients' attitudes about participation in clinical trials. Higher enrollment rates were also observed in the intervention group but the differences did not reach statistical significance. These findings suggest a potential impact of the educational video on clinical trial enrollment; however, larger studies are needed to confirm these findings. Only 3% of women with breast cancer participate in cancer clinical trials nationwide. The lack of awareness about clinical trials is a significant barrier towards clinical trials participation. A study was conducted at a large urban Comprehensive Cancer Center to test (1) the effectiveness of an 18-min educational video on improving attitudes toward clinical trials and trials enrollment among new breast cancer patients seen at the Karmanos Cancer Institute, and (2) to assess racial differences in attitudes regarding clinical trials. Participants were randomized to either the educational intervention prior to their first oncology clinic appointment or to standard care. A baseline and 2-week post-intervention survey to assess attitudes toward clinical trials participation was completed by participants. Of 218 subjects recruited, 196 (55% white vs. 45% African American (AA)) eligible patients were included in the analysis. A small increase in therapeutic clinical trial enrollment was observed in the intervention arm but was not statistically significant (10.4% vs. 6.1%; P = 0.277). The intervention also did not result in a clear improvement in patients' attitudes toward clinical trials at posttest. However, a lower enrollment rate for the AA women was noted after adjusting for stage (OR = 0.282, P = 0.049). Significantly more negative scores were noted in 3 out of the 5 baseline attitudinal scales for AA women. The educational video did not significantly increase enrollment in breast cancer clinical trials. The findings that AA women had significantly more negative attitudes toward clinical trials than white women may partially explain the racial disparity in enrollment. An educational video remains a simple and cost-effective way to educate patients. Future studies should focus on designing a new educational video to specifically target cultural and attitudinal barriers in the AA population to more effectively change attitudes and increase trial enrollment. The purpose of this study was to systematically compare two audiotape formats for the delivery of information relevant to informed consent to participate in a clinical trial in breast oncology, and to establish the feasibility of adding a consultation recording protocol to a clinical treatment trial.
                Participants were 69 women with newly diagnosed breast cancer and 21 oncologists from 5 Canadian cancer centers. Patients were block randomized to one of three groups: 1. standardized audiotape; 2. consultation audiotape; or 3. both audiotapes. Patients received their tapes immediately following the clinical trial consultation. Patient outcomes included perception of being informed about clinical trials, knowledge of information relevant to providing informed consent to a clinical trial, and satisfaction with communication during the consultation.
                The consultation audiotapes contained less trial-related information than the standardized audiotape but there were no differences in clinical trial knowledge or perception of being informed across the intervention groups. Patients expressed a marginally significant preference for consultation audiotapes over standardized audiotapes.
                Patients tended to prefer receiving an audiotape of their own consultation over a standardized audiotape. The majority of oncologists considered the audiotape intervention feasible but were less enthusiastic about being involved in a larger study given the accrual challenges that arose when trying to "piggy-back" one randomized controlled trial on an existing clinical trial.
                Copyright (c) 2006 John Wiley & Sons, Ltd. A double-blind randomised controlled trial was conducted on a group of Hong Kong hospital clinicians. The objective was to test if a three-hour educational workshop (with supervised hands-on practice) is more effective (than no training) to improve clinical question formulation, information-seeking skills, knowledge, attitudes, and search outcomes. The design was a post-test-only control group; recruitment by stratified randomization (by profession), blocked at 800. End-user training was more effective than no training in improving clinical question formulation, in raising awareness, knowledge, confidence and use of databases, but had made no impact on preference for secondary databases. It changed the attitude of clinicians to become more positive towards the use of electronic information services (EIS). Participants had higher search performance and outcomes (satisfaction with information obtained (NNT = 3), EIS satisfaction (NNT = 3) and success in problem solving (NNT = 4)). The workshop improved knowledge and skills in evidence-based searching, but this effect gradually eroded with time. Search logs confirmed that follow-up is required if effects are to be sustained. Longer effects on search behaviours appear to be positive. A randomised controlled trial is valuable in identifying cause-and-effect relations and to quantify the magnitude of the effects for management decision-making. People with intellectual disability (ID), like other patient groups, are known to have a limited knowledge of medication. Leaflets are seen as an appropriate means of providing patient information. To test the hypothesis that medication information leaflets would improve the knowledge and care of the target group, the present authors designed a randomized trial and planned to do subgroup analyses where appropriate. The participants were individually randomized to two groups. A control group was given verbal medication information by their nurse or psychiatrist, and a study group was given specifically designed leaflets in addition to verbal information. The present authors recruited 54 people with mild to moderate ID and mental illness, aged 18 years and older, who were taking psychiatric medications. Questionnaires administered by a blind interviewer recorded outcomes such as medication knowledge and satisfaction at two time points. The participants with mild ID in the leaflet group had significantly reduced medication knowledge and understanding. There were no significant differences in satisfaction with clinicians and medication. Patient information leaflets may confuse people with mild ID in the short term. Other patient groups with cognitive deficits may have similar outcomes. Evaluation of outcomes of health education initiatives is important. The study objective was to assess the relative effects of 2 approaches to teaching about a clinical trial, in terms of patients' satisfaction, information understanding, and whether or not they would enter such a trial. One hundred patients receiving radiation therapy for a variety of cancer diagnoses were randomized to receive information about a hypothetical trial, either by audio tape or interactive computer program. A day later, information understanding was assessed. One week later, method satisfaction and whether respondents would enter such a trial were assessed. There were no differences in understanding or satisfaction. Members of the computer program group tended to report a more positive attitude towards trial entry (chi 2 = 4.0; 1 df; P = 0.05). Overall, refusers tended to be women with higher understanding scores. The results suggest that teaching with interactive components might not adversely affect trial accrual. Further work involving an actual trial entry decision is merited; the sex of the respondent should be controlled in designing this future work. Decision aids (DAs) are increasingly being developed to help patients make shared health care decisions with their practitioners. There are no formal comparisons of the efficacy of different delivery methods. Interactive computerized delivery methods have the advantage of allowing patients control over flow of information and to receive feedback on their comprehension. The purpose of this study was to compare the efficacy of an interactive computerized DA for women considering long-term hormone replacement therapy, to that of a validated audio-booklet version of the same intervention. Fifty-one peri-menopausal women were randomized to use either the computerized or the standard audio-booklet version of the DA. The computerized version presented identical information with the addition of feedback modules to reinforce the participant's understanding. The patients were interviewed with a pre- and post-intervention questionnaire. The computerized DA improved realistic expectations by 52.7% over baseline versus 27.6% with the audio-booklet (P=0.015). Knowledge (Kn) scores improved by 17.5 and 8.4% for the computer and standard DA groups, respectively (P=0.019). The results of this study have implications for future DA design, and other areas where patient Kn and understanding are important, such as in the setting of informed consent. Patient surveys are commonly distributed at the end of a multicenter clinical trial. This Antiarrhythmics Versus Implantable Defibrillators (AVID) substudy prospectively explored the relationship between methods used in distributing a survey and the quantity of responses received. AVID was a multicenter, randomized trial comparing survival in arrhythmia patients treated with antiarrhythmic drugs versus implantable defibrillators. At study termination, a patient satisfaction survey was mailed to the 664 surviving participants. Questions included reasons for study participation, study benefits and problems and quality of care. Survey mailings were stratified by four factors in a 2x2x2x2 factorial design: delivery mode (overnight vs. regular mail), certificate of appreciation, timing of administration ("early" vs. "late") and cover letter signed by a physician versus coordinator. Patients were randomly assigned to received one of 16 combinations of these four factors. Clinical characteristics and response rates were evaluated. Patients were more likely to return surveys delivered by overnight mail (75% vs. 68%, p=0.04), with no certificate of appreciation enclosed (75% vs. 68%, p=0.05) and administered close to the time of study closeout (79% vs. 72%, p=0.085). Compared to the 184 nonrespondents, the 456 (71%) respondents were older, Caucasian, lived with others, were high school graduates and less likely to have Medicare/Medicaid or HMO insurance (p<0.03). Physician recommendation was the most common reason cited for trial participation. Main benefits included increased knowledge of their medical condition and improved health. Reported problems included parking, transportation and excess clinic wait time. This randomized study demonstrated that methods of patient survey distribution affect the survey return rate. Additional studies should explore mechanisms for maximizing return rates.
                Copyright 2002 Elsevier Science Inc.
The value of audio-visual interventions for people considering participating in clinical trials remains unclear. Evidence is mixed as to whether audio-visual interventions enhance people's knowledge of the trial they are considering entering, and/or the health condition the trial is designed to address; one study showed improved retention of knowledge amongst intervention recipients. The intervention may also have small positive effects on the quality of information disclosed, and may increase willingness to participate in the short-term; however the evidence is weak. There were no data for several primary outcomes, including harms. In the absence of clear results, triallists should continue to explore innovative methods of providing information to potential trial participants. 
Further research should take the form of high-quality randomised controlled trials, with clear reporting of methods. Studies should conduct content assessment of audio-visual and other innovative interventions for people of differing levels of understanding and education; also for different age and cultural groups. Researchers should assess systematically the effects of different intervention components and delivery characteristics, and should involve consumers in intervention development. Studies should assess additional outcomes relevant to individuals' decisional capacity, using validated tools, including satisfaction; anxiety; and adherence to the subsequent trial protocol.