informing patients about clinical trials

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Clin Investig (1993) 71 : 572-573 Clinical Pharmacology Editorial Clinical Investigator Informing patients about clinical trials B.J. Oddens 2, A. Algra 1, j. van Gijn 1 1 Department of Neurology, University of Utrecht z International Health Foundation, Brussels © Springer-Verlag 1993 In clinical trials the potential subjects eventually decide for themselves whether or not they agree to participate. To allow them to take a reasonable decision on participation, they "must be adequate- ly informed of the aims, methods, anticipated ben- efits, and potential hazards of the study and the discomfort it may entail" (Helsinki Declaration) [3]. Physician-investigators sometimes feel uncom- fortable with this obligation of "informed con- sent" from participants. In a study covering eight Western countries, 22% of surveyed physicians in- dicated that they never ask for informed consent when entering patients in a clinical study [16]. Phy- sicians sometimes believe that informed consent is an obstacle in obtaining a sufficient number of par- ticipants for a study. Some also doubt whether patients really want to be fully informed about their disease, treatment, and study procedures, and whether patients sufficiently understand the infor- mation provided [16]. These considerations make sense and cannot easily be overlooked. Indeed, fears that patients do not sufficiently understand and retain the infor- mation provided in consent procedures have repea- tedly been shown justified [2, 4, 8, 10]. On the other hand, it is even more important to realize that patients generally wish to receive full informa- tion on their individual disease and on any experi- mental study design [17]. The public opinion about clinical trials and participation in such studies is very positive [5], and full disclosure of information about a trial design does not considerably deter patients from enrollment [14]. Most important, however, is the consideration that well-informed patients feel more activated to continue participat- ing in such studies [13]. This process of sharing responsibility is considered to diminish drop-out rates and to contribute to the success of the study. Obviously, patients expect a good physician to in- form them carefully and fully, and if the informa- tion is well-provided, this may influence the success of the clinical investigation. An important question is therefore how current procedures for informed consent can be optimized. Careful planning of the informed consent pro- cedure is the key to having well-informed partici- pants. In the planning phase the investigators must take several decisions, preferably in an explicit fashion. The first decision concerns the content of the information that is provided to potential study subjects. The Helsinki Declaration indicates that information is needed about the background of the study - including the scientific inability to rec- ommend (one of) the tested treatment(s) over other treatments - and also the aims of the study, its design, and potential advantages and disadvan- tages of the various treatments or procedures under study [3]. Open discussion of these topics helps investigators to decide in how much detail this information should be provided. Such a dis- cussion also provides the possibility to compile a practical aide-memoire of topics to be mentioned when patients are eventually told about the study. A second decision concerns whether written in- formation is handed out to patients. In the United States and many other countries, written informa- tion is a legal obligation, but also in countries where this is not compulsory investigators often decide to prepare such information. Written infor- mation is something to be valued: it contributes substantially to a well-balanced decision on the part of the patient. However, studies evaluating written information have shown that the text is frequently incomprehensible to persons who read little [10-12]. Basic guidelines for improving such information are very simple and probably sound familiar to everyone: use short sentences, short words, and concepts that average readers will un- derstand [1]. Moreover, it is important to avoid the passive voice, unnecessary words, capitals, and abbreviations. Testing written information in a sample of lay persons is important, but not every- one is prepared to admit that parts of the text are difficult to grasp. Therefore it is also advisable to use simple readability tests. These tests are very useful for evaluating written material and for as- sessing whether the text is comprehensible to per- sons of all educational levels [1, 7, 12]. The use

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Page 1: Informing patients about clinical trials

Clin Investig (1993) 71 : 572-573

Clinical Pharmacology Editorial Clinical

Investigator

Informing patients about clinical trials B.J. Oddens 2, A. Algra 1, j. van Gijn 1 1 Department of Neurology, University of Utrecht z International Health Foundation, Brussels

© Springer-Verlag 1993

In clinical trials the potential subjects eventually decide for themselves whether or not they agree to participate. To allow them to take a reasonable decision on participation, they "mus t be adequate- ly informed of the aims, methods, anticipated ben- efits, and potential hazards of the study and the discomfort it may entail" (Helsinki Declaration) [3]. Physician-investigators sometimes feel uncom- fortable with this obligation of " informed con- sent" from participants. In a study covering eight Western countries, 22% of surveyed physicians in- dicated that they never ask for informed consent when entering patients in a clinical study [16]. Phy- sicians sometimes believe that informed consent is an obstacle in obtaining a sufficient number of par- ticipants for a study. Some also doubt whether patients really want to be fully informed about their disease, treatment, and study procedures, and whether patients sufficiently understand the infor- mation provided [16].

These considerations make sense and cannot easily be overlooked. Indeed, fears that patients do not sufficiently understand and retain the infor- mation provided in consent procedures have repea- tedly been shown justified [2, 4, 8, 10]. On the other hand, it is even more important to realize that patients generally wish to receive full informa- tion on their individual disease and on any experi- mental study design [17]. The public opinion about clinical trials and participation in such studies is very positive [5], and full disclosure of information about a trial design does not considerably deter patients from enrollment [14]. Most important, however, is the consideration that well-informed patients feel more activated to continue participat- ing in such studies [13]. This process of sharing responsibility is considered to diminish drop-out rates and to contribute to the success of the study. Obviously, patients expect a good physician to in- form them carefully and fully, and if the informa- tion is well-provided, this may influence the success of the clinical investigation. An important question is therefore how current procedures for informed consent can be optimized.

Careful planning of the informed consent pro- cedure is the key to having well-informed partici- pants. In the planning phase the investigators must take several decisions, preferably in an explicit fashion. The first decision concerns the content of the information that is provided to potential study subjects. The Helsinki Declaration indicates that information is needed about the background of the study - including the scientific inability to rec- ommend (one of) the tested treatment(s) over other treatments - and also the aims of the study, its design, and potential advantages and disadvan- tages of the various treatments or procedures under study [3]. Open discussion of these topics helps investigators to decide in how much detail this information should be provided. Such a dis- cussion also provides the possibility to compile a practical aide-memoire of topics to be mentioned when patients are eventually told about the study.

A second decision concerns whether written in- formation is handed out to patients. In the United States and many other countries, written informa- tion is a legal obligation, but also in countries where this is not compulsory investigators often decide to prepare such information. Written infor- mation is something to be valued: it contributes substantially to a well-balanced decision on the part of the patient. However, studies evaluating written information have shown that the text is frequently incomprehensible to persons who read little [10-12]. Basic guidelines for improving such information are very simple and probably sound familiar to everyone: use short sentences, short words, and concepts that average readers will un- derstand [1]. Moreover, it is important to avoid the passive voice, unnecessary words, capitals, and abbreviations. Testing written information in a sample of lay persons is important, but not every- one is prepared to admit that parts of the text are difficult to grasp. Therefore it is also advisable to use simple readability tests. These tests are very useful for evaluating written material and for as- sessing whether the text is comprehensible to per- sons of all educational levels [1, 7, 12]. The use

Page 2: Informing patients about clinical trials

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of such tests, and subsequent adaptation of written information so that it passes these tests successful- ly, will undoubtedly result in effective information material.

Other necessary decisions concern the circum- stances in which informed consent is obtained. Sometimes it is inevitable that patients are in- formed about the trial while they are hospitalized. Hospitalized patients, however, need more time and attention for understanding the essentials of medical information than nonhospitalized patients [6, 14]. When it is not possible to postpone the informed consent procedure to the first follow-up visits, it is necessary to provide additional time and attention. The same measures apply when a clinical trial concerns elderly patients, because these have more difficulties in understanding medi- cal information than younger subjects [6, 15]. In general it is also wise to allow patients the possibili- ty to discuss potential participation with relatives and friends. This has been proven to result in better motivation for taking part in a study because friends and relatives often convince the patient that this is important and necessary [9, 13].

Thus, explicit planning of informed consent procedures probably leads to improved insight on the part of potential participants. Such patients are more firmly convinced of their decision to par- ticipate and consequently to continue participat- ing, in other words not to drop out. In long-term investigations progress reports for participants about the course of the study keep them involved and increase the chances of success of the study. Above all, truly informed consent is expected from a good physician. Patients appreciate honesty from their physician. A careful provision of information that is not only complete but also comprehensible and attuned to the situation is such a part of good clinical practice that it is worth striving for.

2. Bergler JH, Pennington AC, Metcalfe M, Freis ED (1980) Informed consent: how much does the patient understand? Clin Pharmacol Ther 27:435-440

3. British Medical Association (1981) The handbook of medi- cal ethics. BMA, London, pp 68-69

4. Cassileth BR, Zupkis RV, Sutton-Smith K, March V (1980) Informed consent - why are its goals imperfectly realized? N Engl J Med 302: 896-900

5. Cassileth BR, Lusk EJ, Miller DS, Hurwitz S (1982) Atti- tudes toward clinical trials among patients and the public. JAMA 248:968 970

6. Fitten LJ, Waite MS (1990) Impact of medical hospitaliza- tion on treatment decision-making capacity in the elderly. Arch Intern Med 150:1717-1721

7. Grundner TM (1978) Two formulas for determining the readability of subject consent forms. Am Psychol 33:773- 775

8. Lyn6e N, Sandlund M, Dahlqvist G, Jacobsson L (1991) Informed consent: study of quality of information given to participants in a clinical trial. Br Med J 303:610-613

9. Morrow G, Gootnick J, Schmale A (1978) A simple tech- nique for increasing cancer patients' knowledge of informed consent to treatment. Cancer 42 : 793-799

10. Oddens BJ, Algra A, Van Gijn J (1992) Hoe goed zijn deel- nemers aan een klinisch onderzoek geinformeerd? Ned Tijdschr Geneesk 136:2272 2276

11. Priestly KA, Campbell C, Valentine CB, Denison DM, Buller NP (1992) Are patient consent forms for research protocols easy to read? Br Med J 305:1263-1264

12. Rivera R, Reed JS, Menius D (1992) Evaluating the readabi- lity of informed consent forms used in contraceptive clinical trials. Int J Gynecol Obstet 38 : 22%230

13. Rodenhuis S, Van den Heuvel WJA, Annyas AA, Schraf- fordt Koops H, Sleijfer DT, Mulder NH (1984) Patient mo- tivation and informed consent in a phase I study of an anticancer agent. Eur J Cancer Clin Oncol 20:457-462

14. Simes RJ, Tattersall MHN, Coates AS, Raghavan D, Solo- mon HJ, Smartt H (1986) Randomised comparison of pro- cedures for obtaining informed consent in clinical trials of treatment for cancer. Br Med J 293 : 1065-1068

15. Stanley B, Guido J, Stanley M, Shortell D (1984) The elderly patient and informed consent. JAMA 252:1302-1306

16. Taylor KM, Kelner M (1987) Informed consent: the physi- cian's perspective. Soc Sci Med 24:135-143

17. Van Uden MMAT, Van Dam FSAM (1986) Informed con- sent bij klinisch kankeronderzoek; psychologische aspecten. Ned Tijdschr Geneesk 130: 2078-2082

References

1. Albert T, Chadwick S (1992) How readable are practice leaflets? Br Med J 305:1266-1268

B.J. Oddens, MD International Health Foundation Avenue Don Bosco 8 B-1150 Brussels, Belgium