Consumer involvement in consent document development: a multicenter cluster randomized trial to assess study participants' understanding. Development and evaluation of written patient information for endoscopic procedures. Effects of client interviewers on client-reported satisfaction with mental health services. Patient-controlled analgesia: what information does the patient want? Comparison of patient and staff surveys of consumer satisfaction. Does deliberation make a difference? Results from a citizens panel study of health goals priority setting.
Despite widespread agreement on the importance of informed consent in clinical research, uncertainty remains about the adequacy of current consent procedures and documentation.
                The objective of the study was to compare an informed consent document developed by a consumer group of potential study participants to one developed by the study investigators. The study was a cluster randomized, controlled study embedded in a 'parent' randomized controlled trial of 1092 participants with Gulf War veterans' illnesses recruited in 1999-2000 at 20 US medical centers. Centers were randomized to the investigator-developed or participant-developed consent document. The primary outcome measure was an Informed Consent Questionnaire-4 (ICQ-4), a validated four-item scale measuring self-reported participant understanding scored from 0 to 1. Secondary outcomes included the Client Satisfaction Questionnaire-8 and measures of study refusal and adherence to the parent trial protocol.
                There were no significant differences between consent documents on the ICQ-4 score overall or at any of the time points. Mean (95% CI) treatment differences ranged from +0.020 (-0.015, 0.055) (better understanding) at entry to -0.021 (-0.054, 0.012) (worse understanding) at three-months for the participant versus the investigator document group. There were also no significant differences in satisfaction, adherence to the protocol, or in the proportion of patients who refused to participate in the trial.
                The consumer group may not have been representative of the study participants and they did not suggest dramatic changes to the consent document. The outcome assessment questionnaire was not validated prior to the trial's initiation.
                Consumer modification of the consent document did not lead to either benefit or harm in understanding, satisfaction, or study refusal and adherence rates. This study did demonstrate, however, that embedding consent studies in a clinical trial is feasible and can address important questions about informed consent without disrupting the primary study. In the process of revising our written patient information, we wanted to incorporate some patient feedback into the text, and to compare the new brochures with the old one in terms of procedure-related anxiety and general patient satisfaction.
                A total of 136 patients were asked about their present sources of information and issues they would like more information on. New brochures were developed for upper endoscopy, colonoscopy, and endoscopic retrograde cholangiopancreatography (ERCP), and 235 consecutive patients were then randomized to receive either the new brochures or the old one. Before the endoscopy procedure, the patients' sources of information, level of anxiety (on a five-point Likert scale) and general satisfaction with the written information was assessed. In addition, 89 patients completed a similar questionnaire after completing the endoscopic procedure, recording their degree of anxiety and discomfort during the procedure, and the appropriateness of the written information they had received.
                The written brochure was regarded as providing important information by 79% of the patients, while only 31% felt they had received important information from their referring doctor. The general level of anxiety was 2.0 (slightly anxious) with both brochures, with a mean score of 2.1 and 1.9 for the old brochure and the new one, respectively (P = 0.04). Previous endoscopy, male sex and high age were associated with a lower anxiety score. The post-endoscopy response indicated that the patients had received a realistic description of the procedure. The new brochures were rated as "excellent" or "very good" by 87% of the respondents.
                We have developed a new set of information brochures which appear to serve the purpose of providing adequate information, without causing patients undue anxiety. A study at two outpatient facilities compared two methods of collecting data on client satisfaction with mental health services provided by case managers and by physicians. A satisfaction survey instrument was developed with input from clients. A total of 120 clients were randomly assigned to be interviewed by either a staff member or a client. Clients from both facilities reported high levels of satisfaction regardless of the type of interviewer. Clients gave a significantly greater number of extremely negative responses when they were interviewed by client interviewers. No difference between the two groups was found in overall satisfaction with services received from case managers or physicians. To formulate and evaluate an information leaflet for patients using patient-controlled analgesia (PCA), incorporating information thought to be important by patients.
                The benefit of current information leaflets, written by professionals, has not been studied and their value to patients is unknown.
                Previous studies have shown that information leaflets were poorly designed and written in language too difficult for patients to understand.
                Seven focus groups were conducted to establish what information patients wanted to know about PCA. This information was incorporated into a new information leaflet. One hundred patients were randomized to receive either the new leaflet or the old leaflet in current use. A questionnaire was used to establish whether the new leaflet was more clear and informative than the old one.
                Patients wanted to know that the drug used in PCA was morphine. They wanted more information about side-effects, needed to be reassured that it was safe, and that they could not overdose or become addicted. They wanted detailed instructions and diagrams about the technique. The questionnaire study established that the new leaflet was clearer and more informative.
                Patients' contribution led to major change, producing a leaflet which was clearer, more attractive, more informative and which proved more satisfactory to patients. nan How to involve the public in setting health and health care priorities is a constant challenge for health system decisions. Policy maker interest in involving the public in increasingly complex and value-laden priority setting processes has led to the use of deliberative public involvement methods designed to promote discussion and debate among participants with the objective of obtaining more informed and consensual views. These methods have not been evaluated rigorously using controlled designs with pre- and post-test measurements. We examined, using a controlled design, the effects of introducing different opportunities for deliberation into a process for obtaining public input into a community health goals priority setting process. Our findings indicate that deliberation does make a difference to participant views. As more deliberation is introduced, participant views may be more amenable to change. Deliberation also offers the potential for views to become more rather than less entrenched. While we are beginning to understand the difference deliberation makes to participant views, we are still at an early stage in understanding the process through which these differences come about and what difference deliberation makes to broader outcomes such as civic competence, civic engagement and health policy decisions.
There is little evidence from randomised controlled trials of the effects of consumer involvement in healthcare decisions at the population level. The trials included in this review demonstrate that randomised controlled trials are feasible for providing evidence about the effects of involving consumers in these decisions.