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The feasibility of clinical trials depends, among other factors, on the number of eligible patients, the recruitment process, and the readiness of patients to participate in research. Generally, not more than 5% to 10% of patients who are screened for large, multicentre trials on affective disorders and schizophrenia are recruited (1). Greil and others have shown that a large number of patients may not participate in a trial for reasons other than the formally stated inclusion and exclusion criteria. (2). One of the major obstacles to inclusion may be clinicians’ belief that the research is intrusive. They often may overestimate the negative effects from participating in research, compared with patient perception (3,4). Although the selection and the recruitment process of patients is of crucial importance for evaluating the generalizability of the results obtained in clinical trials, until now only sparse attention has been directed to these topics (2). Seeking patient views about their experiences in research projects may allow investigators to identify areas of research that are important to patients, to question how patients’ experiences may affect research outcomes, and to develop more effective recruitment and retention strategies. The objectives of this study were to evaluate the general readiness of psychiatric inpatients to give their consent to different forms of studies and to assess their reasons for accepting or refusing a hypothetical participation. MethodsThe survey took place in the psychiatric hospital of the University of Lausanne, Switzerland, which serves an urban and suburban catchment area of 240 000 inhabitants. Age range of admitted patients was 18 to 65 years. About 1500 admissions are registered yearly, and the mean length of stay is 21 days. A total of 100 patients consecutively admitted to the hospital were contacted during the first 3 days of hospitalization and were interviewed with respect to their willingness to participate in a study. The following inclusion criteria were chosen to exclude patients who would be ineligible for studies for practical reasons: 1) the ability to give informed consent to a study, 2) sufficient knowledge of at least 1 official Swiss language (French, German, or Italian), and 3) expected hospitalization duration of at least 3 days. Data were collected with a semistructured interview specifically designed for this study. After patients gave their consent for an interview, study scenarios were described and explained. These included a drug trial with an already marketed medicament, a premarketing drug trial, a double-blind drug trial, a blood sampling (for example, genetic analyses), a study based on 1 interview, repetitive interviews, a study that required interviewing family members (that is, for epidemiologic purposes), and a follow-up after the hospital discharge. For each study scenario, patients were asked whether they would be ready to participate if such a study were to be organized in the service. If the patient refused a study type, it was proposed again, but this time with the additional prospect of a financial indemnity for participants. Next, we explored the reasons for patient refusal or agreement to participate in studies generally. We asked the patients for their reasons for not participating, even though they had agreed to participate in all types of studies in the first part of the interview. In the same way, we requested that they provide reasons for favouring participation, even though they refused all previous studies. This was first explored with an open question. Subsequently, patients were asked to select reasons or motivations from a list of predetermined answers. The predetermined answers for favouring participation were as follows: 1) the potential benefit from a new treatment, 2) the potential advantage of consideration as a “special” patient, 3) to please the physician, 4) to aid science progress and to help future patients, and 5) the financial incentive. The predetermined reasons against participation included the fear of being considered a laboratory rat, the fear of adverse drug events, the potential inefficacy of the study treatment, unwillingness to waste time with research, the lack of financial incentives, and the lack of confidence in research doctors. In a final question, the patients were asked to choose from a list of persons from whom they would seek advice while deciding on participation in a study. The proposed alternatives were a relative, a friend, the family physician, the hospital physician, a nurse, another caregiver, and other patients. Finally, data were collected concerning the diagnosis (ICD-10), the sex, the age, and the occurrence of previous hospitalization. The impact of sex, age, previous hospitalizations, and diagnosis on the readiness to participate and on the reasons for agreeing or refusing to participate in a study was assessed using chi-square or Student’s t-test statistics. ResultsAll patients consecutively admitted were screened for eligibility, and the first 100 (59 women and 41 men) who met the criteria were interviewed. Of the patients, 56% had been hospitalized previously at the psychiatric hospital, University of Lausanne. The mean (SD) age was 36.6 (12.7) years. The primary diagnosis was defined as the one that motivated the current hospitalization. The primary diagnosis categories, according to ICD-10, were organic mental disorders (F0) (2%); mental and behavioural disorders owing to use of psychoactive substances (F1) (8%); schizophrenia, schizotypal, and delusional disorders (F2) (30%); mood (affective) disorders (F3) (42%); neurotic disorders (F4) (4%); and disorders of adult personality and behaviour (F6) (14%). Consent to Participate in Different Hypothetical Studies
Reason for Agreeing or Refusing to Participate
When explored with an open question, most patients revealed that helping science to progress and allowing future patients to benefit from this progress were their main motivations (59%). Of the patients, 20% did not see any reason for not participating in studies. When patients were presented with a list of possible reasons for agreeing or refusing to participate, there was an increase in the degree of awareness of potential benefits and in the negative consequences of participation. Of the subjects, 44% more indicated that their reason for participating was to possibly benefit from a new treatment, and 30% mentioned fear of potential side effects as a reason not to participate. Persons Consulted Prior to Decision
Impact of Sex, Age, Previous Hospitalizations, and Diagnosis No relation existed between age or previous hospitalization and readiness to participate in a study. DiscussionIt is often difficult to recruit subjects for research projects. The restrictive nature of the inclusion and the exclusion criteria often makes it necessary to assess a large number of patients before a sufficient number of suitable subjects can be identified. Thus, substantial resources need to be allocated to this task (2). Because research is vital for improving care, it is important to identify factors that may complicate the recruitment process. To protect patients from the inconvenience that research projects can create, clinicians as well as researchers sometimes hesitate to propose these research projects. Our results, however, suggest that this assumption may be wrong. This study’s most striking finding is that most patients who were interviewed appeared to have a rather positive view of research; in fact, over two-thirds declared that they would participate in research projects. These results contrast with a recent study of 289 internal medicine outpatients; the overall hypothetical acceptance rate for an intervention trial was much lower (19.7%) (5). It is likely that the hypothetical nature of the research projects described to these patients rendered them more acceptable and that, in a real recruitment situation, the acceptance rate might be significantly lower. This is suggested by the observation that the schizophrenia patients (who sometimes seemed to think their answers would commit them to research) had a lower acceptance rate. Further, the results may have been influenced by a social desirability bias, patients being keen to please their doctors, and even more so, if no real risk existed from inclusion in a study. Nevertheless, the most common spontaneously mentioned motivation for agreeing to take part in a study was the intention to help science progress and to allow future patients to benefit from improved diagnosis and treatment. This altruistic motivation gives more credibility to the high potential acceptance level that is observed and is in keeping with the previous observation that patients with schizophrenia view helping others and helping science as important reasons for protocol participation (4). Weiss Roberts and others observed that patients endorse the feeling of hope associated with research involvement, a perspective that was underestimated by the psychiatrists interviewed during the same study (4). Similarly, in a further study, psychiatric patients noted that participating in the research allowed them to contribute to the care of other patients and to donate to science (6). Another interesting observation is that, although money is often considered a motivator that could positively influence patient willingness to participate in a study, the impact of monetary incentives was marginal in our study, convincing few formerly reluctant patients to consent. Likewise, the presence or lack of a financial incentive was rarely chosen as an argument to agree or refuse to participate. This confirms other studies, wherein results have found that a clinician’s recommendation to support participation was a positive influence and had similar value to a monetary incentive (6,7). Although 43% of patients indicated that they would discuss their possible participation with relatives, more patients stated that they would rather rely on their treating physicians, either their family doctor (65%) or their hospital physician (54%). This confirms previous findings that patients greatly value the advice of their doctors with respect to research—an impact that psychiatrists tend to underestimate (4,7). Still, this study has some important limitations. Patients may have a differentattitude toward the prospect of real enrollment in a research project, and the validity of the procedure may be questioned: direct comparisons of consent to real and hypothetical studies have until now remained unpublished. It is likely, however, that the patients were able to perceive the implications of the various types of projects that were proposed and that their readiness to participate was determined by this perception. Previous studies have used comparable designs that presented hypothetical studies to patients (5,7–10). These studies suggest that patients were competent to discern study characteristics, such as risks and benefits of specific procedures, when confronted with hypothetical vignettes in structured interviews and that their assessments of the implications of the studies were similar to those of psychiatrists (7). In conclusion, although the situation may differ in the context of a real research project, it is likely that an important proportion of hospitalized psychiatric patients would be ready to participate in clinical studies, principally for altruistic reasons. It appears that clinicians, and treating doctors in particular, can play an important role in facilitating the recruitment process. Most patients trust them when they feel ambivalent about participation and would rely on their decision, Clinical research is fundamental for improving treatment. The larger the population studied and the wider the range of patients included, the more likely it is to lead to findings that are applicable and relevant to most patients. Although it is fundamental to allow patients to make an autonomous decision about their participation in a research project, it is also important not to decide for them by assuming that they would, or should, refuse to take part. References1. Angst J, Bech P, Bruinvels J, Engel RR, Ferner U, Guelfi JD, and others. Report on the fifth consensus conference: methodology of long-term clinical trials in psychiatry. Pharmacopsychiatry 1994;27:101–7. 2. Greil W, Ludwig-Mayerhofer W, Steller B, Czernik A, Giedke H, Müller-Oerlinghausen B, and others. The recruitment process for a multicenter study on the long-term prophylactic treatment of affective disorders. J Affect Disord 1993;28:257–65. 3. Marshall RD, Spitzer RL, Vaughan SC, Vaughan R, Mellman LA, McKinnon RA, and others. Assessing the subjective experience of being a participant in psychiatric research. Am J Psychiatry 2001;158:319–21. 4. Weiss Roberts L, Warner TD, Brody JL. Perspectives of patients with schizophrenia and psychiatrists regarding ethically important aspects of research participation. Am J Psychiatry 2000;157:67–74. 5. Dazzi D, Agnetti B, Bandini L, Corradini P, DeGiovanni F, Ghillani M, and others. What do people think (and know) about informed consent for participation in a medical trial. Arch Int Med 2001;161:768. 6. Carey MP, Morrison-Beedy D, Carey KB, Maisto SA, Gordon CM, Pedlow CT. Psychiatric outpatients report their experiences as participants in a randomized clinical trial. J Nerv Ment Dis 2001;189:299–306. 7. Weiss Roberts L, Warner TD, Brody JL, Roberts B, Lauriello J, Lyketsos C. Patient and psychiatrist ratings of hypothetical schizophrenia research protocols: assessment of harm potential and factors influencing participation decisions. Am J Psychiatry 2002;159:573–84. 8. Stanley B, Stanley M, Lautin A, Kane JSN. Preliminary findings on psychiatric patients as research participants: a population at risk? Am J Psychiatry 1981;138:669–71. 9. Stanley B, Stanley M, Stein J, Guido L, Transit RP. Psychopharmacologic treatment and informed consent: empirical research. Psychopharmacol Bull 1985;21:110–3. 10. Stanley B, Stanley M. Psychiatric patients’ comprehension of consent information. Psychopharmacol Bull 1987;23:375–8. Author(s)Manuscript received February 2003 and accepted April 2003. 1. Associate Physician, Psychiatric University Department for Adult Psychiatry, Prilly-Lausanne, Switzerland. 2. Associate Physician, Early Psychosis Prevention and Intervention Center (EPPIC), Mental Health Service for Kids and Youths, Parkville-Melbourne, Australia. 3. Department Head, Professor of Psychiatry, Psychiatric University Department for Adult Psychiatry, Prilly-Lausanne, Switzerland. 4. Associate Physician, Psychiatric University Department for Adult Psychiatry, Prilly-Lausanne, Switzerland. Address for correspondence:Dr D Zullino, Département Universitaire de Psychiatrie Adulte, Clinique de Cery, CH–1008 Prilly-Lausanne, Switzerland. e-mail: daniele.zullino@inst.hospvd.ch
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