Consent to research in arthritis: quantity of information versus quality.

Abstract

The need to move forward our understanding of arthritis and its safe and effective treatment produces a moral necessity to perform research. Clinical research, where treatments are tested or parameters of arthritis explored in a systematic and unbiased manner, is the foundation of new knowledge. To prevent exploitation of patients in clinical research (1), informed consent is the cornerstone to its ethical conduct. The essential elements of consent are information giving, understanding, voluntariness, competence to decide, and authorization (2). Consent is not a single event but a continuous process throughout a study; therefore the responsibility for maintaining ongoing consent lies with all the research health professionals who deal with the patient during the trial. The consent process crosses all health profession disciplines. Although all the 5 elements of consent outlined above must be present for legitimate consent, it is often at the interface between information giving and understanding of that information that difficulties arise. This is more likely to be a feature of complex trials, and in particular trials involving randomization between a number of treatments, as opposed (for example) to a questionnaire-based observation study. The problem has been clearly shown in the article by Criscione et al in this issue of Arthritis Care & Research, in which patient understanding of key elements of a clinical trial in rheumatoid arthritis was limited (3). This study showed that half the subjects misunderstood the concept of randomization and the detailed descriptions of risk within the trial. Such misconceptions over randomization and the element that chance plays in treatment decisions in trials have been reported in other studies (4,5). It has been shown that patients struggle to make sense of such concepts and have to put them within the context of their own belief system (e.g., that the doctor always selects a treatment specifically for them) (6). Even accepting that some patients will have recall problems that may affect the results of these studies, clearly the results call into question the adequacy of current informed consent because information given is not understood. Two likely contenders for causing misconceptions are the complexity of information sheets and their length. Despite increasing awareness by researchers and ethics committees of the need to make information sheets readable, there is a trend to increase them in complexity and length to comply with recommendations on what information should be included (thereby further reducing readability) (7). The technical language often used in patient information sheets means that patients read and reread them to try and make sense of them (6). One study examining the readability of a sample of trial information sheets showed that 96% were rated at a more difficult reading level than popular tabloid newspapers (8). In clinical treatment, written information on drugs is often given to patients through drug package inserts, although in the UK the Arthritis Research Campaign produces specific drug information leaflets for clinical use. However, trial information sheets often contain information on not just a single drug but on 2 or 3 treatment arms, as well as the required information on trial methodology, voluntariness, confidentiality, and insurance. To improve the technical language used, physicians could make use of the whole clinical team of professionals and a group of patients to review proposed information sheets. In addition, most computer packages offer reading scores, where the length of words, sentences, and paragraphs are calculated to provide an indication of readability. This, combined with lay review of proposed sheets, might make information sheets more accessible. The increasing length of information sheets is becoming problematic because it is likely to reduce readability. It is not uncommon now to see patient information sheets of 7–10 sides of paper. Such detail, required by international recommendations, means that length and coverage must Sarah Hewlett, PhD, MA, RGN: Bristol Royal Infirmary, Bristol, United Kingdom. Address correspondence to Sarah Hewlett, PhD, MA, RGN, ARC Senior Lecturer in Rheumatology (Health Professions), University of Bristol Academic Rheumatology, Bristol Royal Infirmary, Bristol, BS2 8HW, UK. E-mail: Sarah.Hewlett@bristol.ac.uk. Submitted for publication December 26, 2002; accepted January 5, 2003. Arthritis & Rheumatism (Arthritis Care & Research) Vol. 49, No. 3, June 15, 2003, pp 281–282 DOI 10.1002/art.11048 © 2003, American College of Rheumatology