Oncology Physician and Nurse Practices and Attitudes Regarding ...

BRIEF COMMUNICATION Oncology Physician and Nurse Practices and Attitudes Regarding Offering Clinical Trial Results To Study Participants Ann H. Partridge, Nadia Hackett, Emily Blood, Rebecca Gelman, Steven Joffe, Susan Bauer-Wu, Katherine Knudsen, Karen Emmons, Deborah Collyar, Richard L. Schilsky, Eric P. Winer Despite recent interest on the part of advocates and researchers of oncology clinical trials in sharing study results, participants in these trials are not routinely informed about the results. We identified oncology physicians and nurses through the Cancer and Leukemia Group B database and surveyed them about sharing clinical trial results with participants. Of 1977 eligible members, 796 (40.3%) responded to the mailed survey, 497 (62.4%) of whom reported that they offer trial results to participants less than one-fifth of the time. A total of 576 (72.4%) of responders believed that most patients want to know the results of studies, and 634 (79.7%) of responders expressed willingness to offer results to most study participants in the future, believing that most patients want to know trial results and that routinely offering results would not have a negative effect on patients. Concerns of some responders about routinely offering trial results included negative emotional effect on patients, patient difficulty understanding the information, and resources required to offer the results. Of concern, 16.2% (129/796) of responders believed an obligation to offer results to study participants would make them less likely to enroll patients on studies. Future studies should consider sharing trial results with patients and evaluating the process and its effect on both patients and

clinicians. [J Natl Cancer Inst 2004; 96:629 –32] Many health professionals and patient advocates have proposed offering results of cancer clinical trials to study participants as a matter of routine practice (1– 4). Some have argued that there is an ethical imperative to share results of research with patients, as they are partners in the process (1,4). Limited previous research has revealed that many patients want to learn the results of trials in which they have participated (5). As of 2004, clinical trial results have not been routinely shared with study participants unless the results could influence a patient’s ongoing or future care (3). Several cooperative groups are considering implementing a system in the future to share results. In this setting, it is critical to consider clinician attitudes about this disclosure. Hence, we surveyed oncology clinicians to understand their attitudes toward and preferences in regard to sharing study results from clinical trials with study participants. Oncology clinicians, including physicians and nurses, were identified through the Cancer and Leukemia Group B (CALGB) database. An introductory letter and one-time survey was mailed to these CALGB members. Fax, phone, and e-mail reminders, as well as repeat mailings, were used to maximize response rates. Preliminary findings of this study were sent to survey responders on study completion. This study met with the Dana-Farber Partners CancerCare Institutional Review Board’s approval, and informed consent by participants was implied in responding to the survey. The study was primarily descriptive in nature. However, we used logistic regression modeling, the Wilcoxon signrank test, and the Fisher’s exact test for analyses of differences between groups. All statistical tests were twosided. All responders to the survey were included in the analyses except when stated otherwise. Of the 1977 eligible CALGB members, 796 responded to the survey, with an overall response rate of approximately 40.3%. Responders included 125 (15.7%) nurses, 650 (81.7%) physicians, and 21 (2.6%) individuals who indicated they were “other,” including specialists such as psychologists or epidemiolo-

Journal of the National Cancer Institute, Vol. 96, No. 8, April 21, 2004

gists, or who did not respond to the question. Responder characteristics are described in Table 1. The majority of clinicians (63.2%) indicated medical oncology as their specialty, although there was substantial representation from other subspecialty groups, including surgery (17.2%) and radiation oncology (14.2%). Most clinicians (91.5%; 728/ 796) reported seeing at least six new patients per month, and 64.5% (513/796) of clinicians were active in the clinical trial process, in that they enrolled at least six patients per year in clinical trials. The majority of clinicians (74.9%; 596/796) were paid at least in part by salary (clinicians were asked to select all that apply for this question) or had served as a principal investigator (60.8%; 484/796) for a clinical trial. Just under half (40.8%; 325/796) of clinicians had a history of serving on an Institutional Review Board. Of responders, 62.4% (497/796) reported offering results to patients less than one-fifth of the time; only 6.8% (54/796) of responders left this question blank. Trial results should be offered to most patients in trials, according to 78.9% (628/796) of responders (1.6% [13/796] of responders left this question blank), and 72.4% (576/796) of responders indicated that most patients wanted to know the results of their trials (1.6% [13/796] of responders left this question blank). In addition, 62.2% (495/796) of responders did not believe that routinely offering results would have a negative effect on many patients (1.8% [14/796] of responders left this question blank). Although 2.6% (21/796) of responders left this question blank, overall, 79.6% (634/796) of responders reported that

Affiliations of authors: Dana-Farber Cancer Institute (AHP, NH, EB, RG, SJ, SBW, KK, KE, EPW), Brigham and Women’s Hospital (AHP, EPW), and Harvard Medical School (AHP, EB, RG, SJ, SBW, KE, EPW), Boston, MA; University of Chicago, Chicago, IL (RLS); Patient Advocates in Research (PAIR), Danville, CA (DC). Correspondence to: Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute, 44 Binney St., D1210, Boston, MA 02115 (e-mail: [email protected]). See “Notes” following “References.” DOI: 10.1093/jnci/djh096 Journal of the National Cancer Institute, Vol. 96, No. 8, © Oxford University Press 2004, all rights reserved.

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Table 1. Characteristics of responders to a clinician survey regarding offering clinical trial results to study participants (N ⫽ 796) Characteristic Age, y ⱕ35 36–45 46–55 56–65 66–75 ⬎75 Missing Sex Male Female Missing Primary occupation Physician Nurse Otherⴱ/Missing Specialty (physicians only) Surgery (all subspecialties) Radiation oncology Medical oncology Other† Missing No. of new patients seen per month 0 1–5 6–20 21–50 51–100 ⬎100 Missing No. of patients enrolled on clinical trials per year 0 1–5 6–15 16–30 ⬎30 Missing Compensation‡ Salary Hourly Fee for service Missing History of serving as principal investigator of a clinical trial Yes No Missing History of serving on institutional review board Yes No Missing

No. of responders

%

67 321 263 108 15 2 17

8.4 40.3 33.0 13.6 1.9 0.3 2.1

506 273 17

63.6 34.3 2.1

650 125 21

81.7 15.7 2.6

137 113 503 26 17

17.2 14.2 63.2 3.3 2.1

7 39 299 259 73 97 22

0.9 4.9 37.6 32.5 9.2 12.2 2.8

66 209 226 135 152 8

8.3 26.3 28.4 17.0 19.1 1.0

596 50 157 21

74.9 6.3 19.7 2.6

484 296 16

60.8 37.2 2.0

325 454 17

40.8 57.0 2.1

ⴱOther may include occupations such as an epidemiologist and psychologist. †Other may include subspecialties such as psychiatry, neurology, epidemiology, and psychology. ‡Respondents may have selected more than one response.

they were willing to offer trial results to most participants in the future; this group included surgeons (87.7%; 95% confidence interval [CI] ⫽ 76.0% to 89.8%), nonsurgeon physicians (81.9%; 95% CI ⫽ 78.3% to 85.2%), and nurses (78.7%; 95% CI ⫽ 70.3% to 85.6%). The most frequently cited top three benefits, listed by physicians and nurses, of sharing trial results with participants were showing appreciation to patients (66%), courtesy to patients (65%), and improving patient satisfaction with care or quality of life (43%). The most fre630 BRIEF COMMUNICATION

quently cited top three concerns listed by physicians and nurses were potential negative emotional effect on participants (60%), participant difficulty understanding results (54%), and consumption of resources, including money and clinician time (39%). Clinician enthusiasm for offering results to clinical trial participants was high (Fig. 1, A). Overall enthusiasm on this figure was depicted on a scale of 1–7, with 1 representing extreme reluctance, 7 representing extreme enthusiasm. The median level of enthusiasm

among clinicians was 5. Overall enthusiasm did not differ statistically significantly by clinician specialty (P ⫽ .86; Wilcoxon sign-rank test). Using four hypothetical scenarios, we varied the situation (i.e., patient treated with what was ultimately determined to be superior treatment versus patient treated with inferior treatment in a randomized study) and the patient’s current disease status (free of disease versus recurrent disease) to assess the effect on the clinicians’ enthusiasm of offering trial results to participants. Although enthusiasm for sharing trial results remained high, in situations with poor clinical outcomes or when patients received what was ultimately determined to be an inferior treatment, individual clinicians expressed greater reluctance about disclosing trial results (Fig. 1, B); the median within-clinician difference between enthusiasm level for offering trial results to a participant in the superior treatment/ free of disease scenario and the inferior treatment/recurrent disease scenario was 1 (P⬍.001). Willingness of the clinician to share trial results with patients was statistically significantly associated with two responses from clinicians: belief that routinely offering trial results would not have a negative effect on many patients (“yes” versus “no” or “unsure,” odds ratio [OR] ⫽ 4.9, P⬍.001), and belief that most patients want to know the results of trials in which they have participated (“yes” versus “no,” OR ⫽ 3.2, P⬍.001; “yes” versus “unsure,” OR ⫽ 2.1, P⬍.001). Statistically nonsignificant covariates included the factors presented in Table 1. A total of 16.2% (129/796) of responders indicated that an obligation to offer trial results to patients would make them less likely to enroll patients on studies, and 21.6% (172/796) of responders expressed uncertainty about this issue (2.6% [21/796] of responders left this question blank). Interestingly, only 32.3% (257/796) of responders believed that trial results should be offered to next of kin if the patient had died or was unavailable (1.8% [14/796] of responders left this question blank). Clinicians were also asked to select by whom and how the results should be provided to the trial participants; responders were allowed to choose more than one option for each category. The majority of responders


Fig. 1. Enthusiasm of clinicians about offering clinical trial results to study participants. A) Overall clinician enthusiasm about offering clinical trial results to study participants on a scale of 1–7, with 1 reflecting extreme reluctance and 7 reflecting extreme enthusiasm above offering trial results. B) Clinician enthusiasm about offering clinical trial results in study participation varies with trial and patient outcome in randomized clinical trial scenarios. Superior treatment arm/free of disease (dotted line), superior treatment arm/recurrent disease (thin line), inferior treatment arm/free of disease (dot/dash line), and inferior treatment arm/ recurrent disease (square box line with cross). Median within-clinician difference between enthusiasm level for superior treatment arm/free of disease scenarios and inferior treatment arm/recurrent disease scenarios was 1.

(83.0% [661/796]) indicated that trial results should be provided by a patient’s physician (2.4% [19/796] of responders left this question blank), whereas fewer responders felt that trial results should be provided to the participants by a representative of the research team (39.2% [312/796]), a nurse (16.6% [132/796]), or a representative from the sponsoring institution (7.9% [63/796]). The majority (84% [671/796]) of responders believed that trial results should be shared in person (2.4% [19/796] of responders left this question blank). Fewer clinicians felt that trial results should be provided to participants by mail (27.4% [218/796]), phone (17.0% [135/796]), Web site (10.2% [81/796), or e-mail (4.3% [34/796]). An often overlooked aspect of the clinical trial process is communication with participants following a trial. Although clinical researchers have proposed offering trial results to participants, this study confirms that participants are not usually provided with trial results,

despite the fact that the majority of clinicians believe that most participants want to learn the results of the trial they participated in and the argument that clinicians have an ethical obligation to share study results with interested participants (1,4). Although the majority of clinicians surveyed reported a willingness to offer results to trial participants in the future, many clinicians expressed a desire to protect patients from potential effects of negative information. Clinicians may not want to share “bad news,” especially if it will not influence the patient’s future care. Although a paternalistic approach has often been operative in clinical settings, the tenor of the clinician–patient interaction has changed in recent times in favor of a more collaborative relationship (6,7). Of course, even if a clinician wants to protect a patient from negative information, this approach may backfire if the patient learns of the study results from another source (3). Reluctance to share unfavorable results with trial participants may also stem from clinicians’ desires to protect themselves from additional work-related tasks. The routine sharing of trial results with participants would likely entail the use of substantial resources, including clinician time and effort (8). Reluctance to share unfavorable results with participants many also stem from additional clinician concerns. For example, clinicians may not want to share unfavorable results with patients to avoid confronting the reality that treatment on a research study is designed to help future patients and not necessarily the individual patient on the study. Hence, an obligation to offer study results would force clinician-researchers to face this inherent conflict in clinical research. Furthermore, there may also be fear of increased litigation, such as from family members whose relative had been randomly assigned to the inferior arm of a trial and who has subsequently had a bad outcome. The optimal method of sharing study results is not clear. Most clinicians and nurses indicated that the patient’s physician should share the study results and that they should be shared in person. This approach seems, however, to be impractical, and more feasible methods will need to be pursued. Preliminary


data about patient preferences indicate that patients also wish to hear study results from their physicians, but that receiving results by mail is acceptable to the majority of patients (5). There are several additional practical considerations to take into account before we embark on a practice of routinely offering study results to patients, including when the study results are offered, how hard the researchers should work to contact the study participants, whether study results should be offered rather than just given, and whether study results should be offered to next of kin if the study participants are not able to receive the results themselves. Although only a minority of clinicians in this study believed that trial results should be offered to next of kin if the patient had died or was unavailable, preliminary data reveal that most patients would want their loved ones to be informed of the results (5). It will be important to minimize the overall burden of sharing study results with participants to avoid diverting a substantial amount of research funding toward this effort and to avoid creating an accrual disincentive for clinicians. It is concerning that nearly 40% of respondents believed that an obligation to offer study results to patients would or might negatively effect their enrollment of patients on trials. Placing the onus of updating contact information on participants and emphasizing to participants the potential consequences of not maintaining contact may help minimize this burden (4). To our knowledge, no previously published studies have addressed clinician preferences for sharing trial results with study participants. The large sample size and broad-based population of our study support the generalizability of our findings among clinicians who are active in the clinical trials process. However, our study was limited by the use of a questionnaire that was not validated prospectively and by the inherent difficulty of assessing the topic. Furthermore, nonresponse rates seemed to differ by specialty as listed in the CALGB database; 52% of nurses surveyed responded compared with 42% of medical subspecialists, 35% of radiation oncologists, and 33% of surgeons (P⬍.001 for all four groups, P ⫽ .0014 for physicians only). BRIEF COMMUNICATION 631

In summary, few clinicians routinely share trial results with study participants. Although most clinicians are willing to consider routinely sharing study results, several concerns exist. Future studies should evaluate the process and effects of sharing study results with participants in an effort to develop a model that incorporates the views of all parties involved in the research process. This type of research may ultimately improve communication between health care providers and patients, improve the quality of care delivered, and increase patient satisfaction with the care received as part of a clinical trial.

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(3)

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REFERENCES (6) (1) Cancer Leadership Counsel, Cancer Research Foundation of America, Coalition of National Cancer Cooperative Groups, and the Oncol-

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ogy Nursing Society. The Summit Series on Clinical Trials Website—Recommendations and Action Steps. Available at: http://www. cancersummit.org; 2000. Coalition of National Cancer Cooperative Groups Inc. Guidelines for Notifying Patients About Early Closure of Cancer Clinical Trials. Available from: http://www.cancertrialshelp. org; 2002. Partridge AH, Winer EP. Informing clinical trial participants about study results. JAMA 2002;288:363–5. Fernandez CV, Kodish E, Weijer C. Informing study participants of research results: an ethical imperative. IRB Ethics Hum Res 2003;25: 12–9. Partridge AH, Burstein HJ, Gelman RS, Marcom PK, Winer EP. Do patients participating in clinical trials want to know study results? J Natl Cancer Inst 2003;95:491–2. Degner LF, Kristjanson LJ, Bowman D, Sloan JA, Carriere KC, O’Neil J, et al. Information needs and decisional preferences in women with breast cancer. JAMA 1997;277:1485–92.

(7) Charles C, Whelan T, Gafni A. What do we mean by partnership in making decisions about treatment? BMJ 1999;319:780 –2. (8) Fernandez CV, Kodish E, Shurin S, Weijer C. Offering to return results to research participants: attitudes and needs of principal investigators in the Children’s Oncology Group. J Pediatr Hematol Oncol 2003;25:704 – 8.

NOTES Supported, in part, by an American Society of Clinical Oncology Young Investigator Award (Ann H. Partridge) and by grants from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services to the Cancer and Leukemia Group B (CA31946; Richard L. Schilsky, MD, Chairman) and to the Dana Farber Cancer Institute, Boston, MA (CA32291). The contents of this manuscript are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute. Manuscript received September 5, 2003; revised February 6, 2004; accepted February 17, 2004.
