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| A users guide Alejandro R Jadad 8 My wish list: thinking it all over In this chapter I describe what I think are the most important barriers to the optimal use of randomised controlled trials (RCTs) in health care. I also propose some strategies that could be used to overcome them. This is not intended to be a comprehensive list. I just want to share my thoughts with you and, hopefully, motivate you to create your own list of barriers and opportunities, and to think about possible solutions that could be implemented in your own setting. Each section in this chapter starts with a wish and continues with a description of strategies that could be used to overcome barriers to the optimal use of RCTs in health care decision making. You will notice that most of the wishes and barriers described also apply to other types of research information. Some of the strategies to overcome existing barriers may prove difficult to implement in today's world. However, I hope that they (or other effective alternatives) may become feasible in the near future. The following is my wish list. I wish for better RCTsDuring the past ten years, important research efforts have looked at RCTs as the subject rather than the tool of research.1,2 These studies, which have generated valuable empirical evidence about the deficiencies in the design, reporting, dissemination, and use of RCTs in health care, have been consistently ignored by researchers, peer reviewers, and journal editors.2 Given the differences between theideal RCT and the RCTs that are actually conducted, there is a wide gap between methodological research and methodological practice. This gap is analogous to the gap that exists between clinical research and clinical practice (see Chapter 7). Bridging this methodological gap will be as challenging as bridging the clinical gap, and will require important efforts by researchers, funders, journal editors, and peer reviewers. The following are some examples of efforts that are needed if we are to bridge the gap. We need to reduce the likelihood of bias in RCTs We need more trials that address clinically relevant questions Although interest in efforts to include consumers in discussions about the design of RCTs seems to be increasing,7 almost nothing seems to be occurring to increase the role of health planners, managers, and policy makers in the design, execution, and dissemination of RCTs. We need to find effective strategies to include these stakeholders in research decisions and to evaluate the effect of this involvement on the quality and impact of RCTs. Researchers should also understand the limitations of RCTs, feel comfortable with the fact that there are many situations in which RCTs are not feasible or appropriate, and recognise that the question being asked is what should determine the study design that can best answer it.8 We need trials to provide more precise results We need to improve the quality of the reports| We need better ways to present the results of trials to users I wish that information on all ongoing and completed trials was readily available Trials have little use, even if they are perfectly designed, conducted, reported, and written, if they are not available to users. For trials to be readily available, however, the following items are necessary. All trials are registered at inception All trials are published, soon after completion, regardless of the direction of their results Individual trials are incorporated in rigorous systematic reviews I wish that users could access RCTs more efficiently It would be ideal if decision makers could access RCTs when they need them and where they need them. For this to occur, we will need the best available information technology and decision makers who are willing and able to use it. Information technology is evolving rapidly. At no other time in history have there been so many powerful information tools for providers and consumers to access information. We already have resources such as the Cochrane Library and Best Evidence which provide fast and easy access to RCTs and other types of evidence.12 The rapid development of the Internet promises even better opportunities. Keeping up with technological developments, however, is not an easy task for most decision makers. Most people still lack formal training in health informatics and have few opportunities to become familiar with and adopt new technologies. This is compounded by the fact that we know little about the preferences, patterns of utilisation, and barriers to the adoption of different information technologies by different users. If users' skills are to match the techological possibilities, we will need research efforts to address existing knowledge gaps, and strategies to speed up the adoption of new technological developments by people with different backgrounds, expectations, motivations, and skills. Both goals could be achieved through the creation of researchenvironments that simulate real life settings (that is, consulting offices, classrooms, boardrooms, waiting rooms, homes) and serve as laboratories in which learners, educators, researchers, policy makers, providers, and consumers can use state-of-the-art technology to access the best available evidence to guide their decisions. These laboratories could support the study of new informatics tools, human-computer interaction, evidence based decision making, and computer assisted learning. They would also provide ideal conditions for research on barriers that hinder the use of information technology for accessing high quality research evidence, and would support the development of strategies to overcome them in the real world. People involved in efforts to improve the skills of decision makers to access information should be aware that differences in information access will occur within groups of users (for example, rich and poor; old and young; urban and rural; English speaking and non-English speaking) and across groups of users (for example, physicians who lack access to information resources being upstaged by their patients). Although these differences are unavoidable, strategies should be put in place to monitor and minimise them, and to avoid the deleterious effects that may arise from such differences. I wish that all decision makers could understand RCTsEven if RCTs were perfectly designed and readily available to users, they could not influence health care decisions and outcomes if users could not understand them. During the past 15 years, I have noticed that most people do not understand the concept of randomisation and its strengths, the different sources of bias in RCTs, and the role of RCTs in health care decision making. This could be explained, at least in part, by the fact that most efforts to promote a better understanding of RCTs (and research in general) have focused on researchers in training, particularly graduate students. Little has been done to promote an understanding of research among other users of research. Even though some training programmes for health professionals, policy makers, health planners, and managers include courses on research methodology, they often lack formal activities to promote a better understanding of RCTs. The situation for patients, their family members, and other lay members of the public is even worse. These groups, without whom most RCTs would not exist or would not be needed, have been left unaided to handle research information, let alone RCTs. Journalists who have a profound influence on the dissemination and impact of research information are in a similar situation. It would be reasonable to assume that those who understand research will be more likely to use it to their advantage than those who do not understand it. People who do not understand research are more likely to ignore it or misuse it. They also have a higher risk of becoming confused, anxious, and frustrated when trying to use research, which could result in worse health outcomes if irrelevant or biased information is used to guide their decisions. The potentially harmful effects of the lack of understanding of users is now compounded by the amount of information available. Until recently, only health care providers had to deal with information overload. Now, with the growth of the Internet, an increasing number of patients, family members, and other lay members of the public are gaining unprecedented access to information and experiencing the effects of information overload. Against this background, I feel confident in saying that the development and implementation of effective strategies to increase users' understanding of research, and RCTs in particular, is a top priority. Part of the success of these strategies will depend on the way in which the results from research are presented to users (see above). Part also depends on our ability to recognize, understand, and overcome specific barriers to the adequate use of RCTs by different groups of decision makers. Success will also depend on how well these strategies target all groups of potential and actual users of research. Timing will be crucial. To date, efforts to promote a better understanding of RCTs and research have focused mainly on adults. Perhaps the effectiveness of such efforts could be enhanced if they were targeted to younger learners. For instance, the basic principles of decision making, research, and critical appraisal in health care could be incorporated in school curricula7,13 and taught using interactive video games and other innovative computer based methods. If children can understand these principles, they will not only be in a better position to participate in health care decisions, but will require little additional education and reinforcement once they become adults fulfilling the roles of health professionals, policy makers, planners, managers, journalists, patients, family members of patients, and other healthy adult members of society. Efforts to increase our understanding of RCTs should take into account the tendency of human beings to rely excessively on intuition and rules of thumb, to follow inadequately built theories, and to be strongly influenced by vivid experiences and anecdotes.13-17 Efforts also need to account for the fact that research information will be modulated, not only by other types of information, but also by the values and preferences of the decision makers and the unique circumstances in which most decisions are made.18 If trials are to be used efficiently, and if evidence based decision making is to reach its full potential, we will need to couple our efforts to increase the understanding of RCTs with efforts to promote a better understanding of the relationship between RCTs and other study designs, between research information of all kinds and other types of information, and between information available to decision makers, their values and preferences, and the circumstances in which they are making the decisions. We will need a better understanding of the interaction among different groups of decision makers (that is, nurses and physicians, physicians and hospital managers, nurses and patients) in terms of their own information, values, and preferences in different contexts. Gaining this understanding will require different research approaches, input from multiple disciplines, and an enormous commitment at all levels. Closing remarksThe RCT is one of the simplest, most powerful, and revolutionary tools of research.19 Despite their extensive use as research tools over the past 50 years, most trials are biased, too small, or too trivial. It is essential that we make more efforts to protect ourselves against ourselves during the design, analysis, dissemination, and use of RCTs. Such efforts will hopefully benefit patients, scientists, governments, industry, research institutions, funding and regulatory agencies, ethics committees, journalists, and other consumers of information. Overcoming the existing barriers will, however, require innovative research strategies, and unprecedented levels of commitment, participation, and contribution by us all. Only by meeting the current challenges will we ensure that the RCT occupies its righteous place and provides the information that study participants and users of research expect and deserve. References 1. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup D. Improving the quality of reporting of randomized controlled trials - The CONSORT Statement. JAMA 1996;276:37-9. 2. Jadad AR, Rennie D. The randomized controlled trial gets a middle-aged checkup. Editorial. JAMA 1998;279:319-20. 3. Bero LA, Rennie D. Influences on the quality of published drug trials. International J Technol Assess Health Care 1996;12:209-37. 4. Jadad AR, Haynes RB. The Cochrane Collaboration - Advances and challenges in improving evidence-based decision making. Med Decision Making 1998;18:2-9. 5. Jadad AR, Whelan T, Rayno L, Pirocchi J, Farrell S, Neimanis H, Montesanto B, Sobeirajski T, Browman GP.A team approach to pain relief: a guide developed with patients and family members. Supportive Care in Cancer 1996;3:245. 6. Bero L, Jadad AR. How consumers and policy makers can use systematic reviews for decision making. Ann Intern Med 1997;127:37-42. 7. McNamee D. Public's perception of RCTs. Lancet 1998;351:772. 8. Sackett DL, Wennberg JE. Choosing the best research design for each question. Br Med J 1997;315:1636. 9. Haynes RB. Loose connections between peer-reviewed clinical journals and clinical practice. Ann Intern Med 1990;113:724-8. 10. Dickersin K. How important is publication bias? A synthesis of available data. AIDS Education Prevention 1997;9(suppl A):15-21. 11. Chalmers I. Underreporting research is scientific misconduct. JAMA 1990;263:1405-8. 12. Haynes RB, Jadad AR, Hunt DL. What's up in medical informatics? Can Med Assoc J 1997;157:1718-19. 13. Nisbett RE, Ross L. Human inference: strategies and shortcomings of social judgement. Englewood Clifs, N.J. Prentice-Hall Inc., 1980. 14. Tversky A, Kahneman D. Judgment under uncertainty: heuristics and biases. Science 1974;185:1124-31. 15. Redelmeier DA, Rozin P, Kahneman D. Understanding patients' decisions: cognitive and emotional perspectives. JAMA 1993;270:72-6. 16. Enkin MW, Jadad AR. Using anecdotal information in evidence-based health care: heresy or necessity? In review. 17. McDonald CJ. Medical heuristics: the silent adjudicators of clinical practice. Ann Intern Med 1996;124:56-62. 18. Haynes RB, Sackett DL, Gray JRM, Cook DL, Guyatt GH. Transferring evidence from research into practice: 1. The role of clinical care research evidence in clinical decisions [editorial]. ACP J Club 1996;125:A-14; Evidence-based Medicine 1996;1:196-8, 19. Silverman WA, Chalmers I. Sir Austin Bradford Hill: an appreciation. Control Clin Trials 1992;13:100-5.
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Home | Contents | Foreword | Introduction | Acknowledgments | How to order © BMJ Books 1998. BMJ Books is an imprint of the BMJ Publishing Group. First published in 1998 by BMJ Books, BMA House, Tavistock Square, London WC1H 9JR. A catalogue record for this book is available from the British Library. ISBN 0-7279-1208-9 |