74S Abstracts

The general framework of the application is readily adaptable to any data form - only a few minutes are needed to assign data set names. The logic check statements and the data screens require more in-depth customization, the time for which will depend on the complexity of the data collection instrument. The details of the application will be presented with examples of its actual use in ongoing trials. In addition, we have compiled a short manual which describes the exact step-by-step procedures for setting up the application.

67 THE IMPACT OF WRITTEN INFORMATION ON OUTPATIENTS ' KNOWLEDGE

ABOUT AND ATTITUDE TOWARDS RANDOMIZED CLINICAL TRIALS

Lise Lotte Kja~rg~rd, Alexandra Yasmin Kruse, Kim Krogsgaard, Christian Gluud, Erik Lykke Mortensen, Adam Gottschau

and the INFO Trial Group Copenhagen University Hospital

Copenhagen, Denmark

A randomized clinical trial (RCT) enrolled 415 outpatients recruited from a university hospital in Copenhagen in order to investigate a) the baseline knowledge about and attitude towards RCTs and b) the impact on written information on these parameters. Each patient completed a questionnaire regarding knowledge about and attitude towards RCTs. Patients were randomized to either a control group or to receive one of three materials: i) leaflet, ii) brochure or iii) booklet. Each material contained general information regarding RCTs. The information material was returned to the investigators after it had been read by the trial subjects. Two weeks later patients were asked to complete the same questionnaire again. At baseline significantly higher knowledge scores were seen in younger patients and in patients with longer education (p<0.001). Male patients had a significantly more positive attitude towards RCTs (p <0.001). All 3 information materials increased the total knowledge score. The most pronounced effect was observed for the brochure and the booklet. A significantly more positive attitude score was obtained in the booklet arm (p < 0.001). Conclusion: Written information has a positive impact among outpatients on both knowledge about and attitude towards RCTs. More elaborate information seems to have the most positive effect.

68 ZELEN RANDOMIZATION: ATTITUDES OF PARENTS PARTICIPATING IN A NEONATAL CLINICAL TRIAL

Claire Snowdon 1, Diana Elbourne j and Jo Garcia 2 London School of Hygiene and Tropical Medicine ~

London, United Kingdom University of Oxford 2

Oxford, United Kingdom

The process of recruitment to randomized controlled trials can be a difficult experience for all parties involved. Conventionally, consent to participate in a trial (and therefore to receive either treatment) is sought, and then the patient is randomly allocated to a treatment. An alternative approach has been suggested for trials in which the control group receives standard treatment. In this approach (the Zelen design), randomization precedes consent which is only sought from those allocated to the experimental arm of a trial. The control group would not be aware that randomization had taken place. This approach has often been suggested but rarely used. Both statistical and ethical implications have been debated, but a missing voice is that of actual trial participants. This paper reports attitudes to the idea of Zelen randomization of 44 parents with experience of recruitment to the UK Collaborative Neonatal ECMO trial in which conventional randomization procedures were used. The arguments which were given for and against the method pertain to four areas: the giving or withholding

Abstracts 75S

of information, the effect on decision-making, the use of data without parental knowledge and the long term impact for parents. The parents were evenly divided in their acceptance or rejection of the method. Those rejecting Zelen randomization were more likely to be parents of babies allocated to the control group. This suggests that those from whom consent would not be sought, the group that this approach is primarily meant to protect, are most likely to find it unacceptable.

69 SHAM TREATMENTS IN CLINICAL TRIALS:

A REVIEW OF THE LITERATURE

Sandra M. Reynolds The Johns Hopkins University

Baltimore, Maryland

The placebo effect is well documented and much discussed. Models of the mechanism of the placebo have been offered, and the ethics of its clinical application are debated. Placebo effects are potentially present in clinical trials and the blinded, placebo controlled trial is employed to separate the effect of treatment from placebo. This also gives rise to ethical discussion concerning informed consent and the withholding of treatment. In drug trials, masking is a major concern. All groups of patients receive some drug, but neither subjects nor investigators should know which is the active treatment. In trials involving a non-drug treatment, controlling for the placebo effect is more complicated. Because patient response may be influenced by incidental aspects of the treatment, the perception of equipment, and the interaction with the clinician, sham treatments are devised to mimic all aspects of the treatment except for the active element. For complicated interactions like psychotherapy, construction of a true sham treatment may be impossible. Because some treatments are invasive, sham treatment adds a further ethical burden. In 39 reports of clinical trials published from 1993 through 1997 found by a Medline search on the keywords 'sham' and 'clinical', sham treatments most often simulated electrical or magnetic field stimulation, or treatments with devices ranging from lasers to robots. Sham surgeries and electro-convulsive therapy were also reported. This presentation will explore the range of "sham treatments" and the practical and ethical issues raised by their use in clinical trials. Current guidelines and regulations will be reviewed.

70 EVALUATING THE ECONOMIC EFFICIENCY OF ALTERNATIVE

PULMONARY REHABILITATION INTERVENTIONS: COLLECTING COST DATA

Vanessa Duren-Winfield, Mary Ann Sevick and Michael Berry Bowman Gray School of Medicine

Wake Forest University Winston-Salem, North Carolina

The Reconditioning Exercise and Chronic Obstructive Pulmonary Disease Trial a randomized clinical trial to.determine the effects of short-(3 months) versus long-term (18 months) exercise intervention in patients 55-80 years of age with chronic obstructive pulmonary disease. Both groups receive individual fitness assessment counseling sessions followed by a one-bour exercise group program, 3 times per week, for 12 weeks. At the end of 12 weeks, control group patients are provided instruction on the continuation of exercise at home. Intervention group patients continue to participate in the thrice weekly exercise program for an additional 15 months. The primary outcome in the study is physical function. Cost-effectiveness is a secondary outcome. The study is currently concluding recruitment. To date, 129 individuals have agreed to participate in the cost-effectiveness component. The