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Doctors’ and Patients’ Preferences for Participation and Treatment in Curative Prostate Cancer Radiotherapy

Peep F.M. Stalmeier, Julia J. van Tol-Geerdink, Emile N.J.Th. van Lin, Erik Schimmel, Henk Huizenga, Willem A.J. van Daal, Jan-Willem Leer

From the Departments of Radiation Oncology and Medical Technology Assessment, Radboud University Nijmegen Medical Center, Nijmegen; and Arnhems Radiotherapeutic Institute, Arnhem, the Netherlands

Address reprint requests to Peep F.M. Stalmeier, PhD, Radboud University Nijmegen Medical Centre, MTA 138, PO Box 9101, 6500 HB Nijmegen, the Netherlands; e-mail: p.stalmeier{at}mta.umcn.nl

	ABSTRACT

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Purpose: Physicians hold opinions about unvoiced patient preferences, so-called substitute preferences. We studied whether doctors can predict preferences of patients supported with a decision aid.

Methods: A total of 150 patients with prostate cancer facing radiotherapy were included. After the initial consultation, without discussing any treatment choice, physicians gave substitute judgments for patients' decision-making and radiation dose preferences. Physicians knew that several weeks later, patients would be empowered by a decision aid supporting a choice between two radiation doses involving a trade-off between disease-free survival and adverse effects. Subsequently, patient preferences for decision making (whether or not they wanted to choose a radiation dose) and for treatment (low or high dose) were obtained. The chosen radiation dose actually was administered.

Results: Of the patients studied, 79% chose a treatment; physicians believed that 66% of the patients wanted to choose. Agreement was poor (64%; = 0.13; P = .11), and was better as patients became more hopeful (odds ratio [OR] = 4.4 per unit; P = .001) and as physicians' experience increased (OR = 1.09 per year; P = .02). Twenty percent of physicians' preferences, 51% of physicians' substitute preferences, and 71% of patients' preferences favored the lower dose; agreement was again poor (70%; = 0.2; P = .03).

Conclusion: Physicians had problems predicting the preferences of patients empowered with a decision aid. They slightly underestimated patients' decision-making preferences, and underestimated patients' preferences for the less toxic treatment. Counseling might be improved by first informing patients—possibly using a decision aid—before discussing patient preferences.

	INTRODUCTION

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When patients have unvoiced preferences, the physician decides in the patients' best interest. To make this decision, physicians may try to imagine or judge the unvoiced preferences of patients. These so-called substitute judgments have been studied in end-of-life decision making. A general finding is that agreement between substitute and patient preferences is poor,^1-5 suggesting that patients' needs and standards for informed consent may not be met.

Other preferences such as preferences for decision making and treatment selection have been studied. Decision-making preferences reflect whether or not the patient wants to choose himself, or leave the decision to the physician. Treatment preferences reflect which medical treatment the patient wants. During the consultation, physicians hold opinions or substitute judgments about particular patient preferences.

How are these opinions or substitute judgments formed? It is known that physicians may use their own preferences to form their substitute judgments.^1,4 It is also likely that substitute judgments are formed by readily available patient characteristics such as age, education, and disease severity. For example, patients' decision-making preferences are positively associated with female sex and higher education, and decline with age and disease severity.^6-9 It is plausible that these factors affect substitute preferences held by physicians.

Substitute preferences are relevant for medical decision making. They are likely to steer the information detail and level of involvement that is offered to patients. In clinical practice, physicians may assume that they are a good judge of patients' preferences and preferred roles for decision making are not usually asked.^10,11 Patients, in turn, ask few questions.¹² Hence, the delivery of information is largely physician driven.^13,14 The amount of information provided in practice is variable and often too incomplete to facilitate patient decision making.^14,15

The variation in information suggests that physicians know in advance which patients want and which patients reject additional involvement after being informed further. Our study question is whether physicians indeed know these preferences. Given that the physician judgment about patients' involvement wishes precedes the provision of additional information, physicians' opinions were obtained before additional information was provided to patients. The preferences of patients were obtained after additional information was provided because the physician judges what the patient wants after the patient is informed further. In addition, factors affecting agreement between substitute and patient preferences were sought. The context was realistic; that is, the patients' choice was carried out.

	METHODS

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Patients
Between June 2003 and February 2005, all patients with a primary prostate tumor (T1-3, N0, M0) scheduled to undergo radiotherapy were included in this study.^16,17 Exclusion criteria were mental disorders and insufficient knowledge of the Dutch language. Patients were enrolled in two locations: the Radboud University Nijmegen Medical Centre (Nijmegen, the Netherlands) and the Arnhems Radiotherapeutic Institute (Arnhem, the Netherlands).

Procedure
The study was approved by the research ethics committees of both hospitals. In the first visit to the clinic, which lasted about 30 to 45 minutes, the radiation oncologist informed eligible patients that this study focused on "how to involve the opinion of patients in the treatment." The radiation oncologist then asked patients if the researcher could contact them by phone about this study. Physicians did not discuss the choice between two radiation doses with the patient. Physicians completed information about their (substitute) preferences after the patient left the clinic. In the phone call, the researcher told patients that data were collected by means of an interview and several questionnaires. Patients who agreed to participate were sent a consent form and a baseline questionnaire to be completed within a few days.

In the second visit, on average 19 days after the first visit, the researcher interviewed the patients. In this interview, additional information was provided with a decision aid. After 2 days, decision-making and treatment preferences were confirmed by telephone and noted in the patient's medical record. These latter responses were used for the analyses described in this article. Subsequently, the preferred treatment (high- or low-dose radiation) was delivered. Physicians knew that patients' preferences were to be obtained after receiving the decision aid; physicians were familiar with the content of the decision aid.

Interview With Decision Aid
In the second visit, patients were told about the possibility of two treatments in a semistructured interview. A decision aid explained the trade-off between the risks and benefits of higher or lower radiation dose.^16,17 A higher dose leads to better (disease free) survival, but also to more adverse effects. Patients received outcome and risk information on the two alternative treatment options of 70 and 74 Gy effective radiation dose. A literature study yielded data on the following outcomes¹⁸: 5-year overall survival, 5-year disease-free survival, severe erectile dysfunction, severe late GI adverse effects, and severe genitourinary adverse effects. Severe adverse effects were defined as adverse effects that have an impact on daily activities. The probability that these outcomes occurred (risk information) was presented subsequently in frequencies (x of 100 patients) and by means of pie charts.¹⁶ The outcome and risk information was also given to the patients in writing and could be taken home.

The information was tailored to the patient characteristics in terms of prognostic risk and age category. Four separate information groups were distinguished. The first group consists of low-risk patients, who are characterized by a prostate-specific antigen (PSA) value less than 10 ng/mL, a Gleason score less than 7, and a T status of T1 or T2. The other patients were divided into age categories of younger than 57.5 years, 57.5 to 72.5 years, and older than 72.5 years. After receiving the decision aid, 10% of the patients requested and received an additional consultation with the physician to discuss the choice.

Measures
Data were collected on several variables that were expected to affect patients' preferences. Most patient data were collected after the first visit. Patient decision-making and treatment preferences were collected in the second visit, during which the decision aid was presented. For each physician, we recorded sex, years of training as a radiation oncologist, and the number of patients included in the study.

Preferences of Clinicians
Substitute preferences were obtained at the end of the first visit; that is, before patients were informed with the decision aid. Physicians were familiar with the decision aid. With this background knowledge, a general instruction asked physicians to take the patient perspective. Three measures were obtained. The substitute decision-making preference was asked as follows: "Do you believe that this patient wants to decide for himself between the low and high-dose (yes/no)?" The substitute treatment preference was asked as follows: "Assuming that the patient wants to choose, which dose do you believe that the patient will choose (the low dose/the high dose)?" The physician's own preference for treatment was asked as follows: "According to your own opinion, which dose is most suited for this patient (the low dose/the high dose/no preference)?"

Patient Variables
Preferences in patients. After receiving the decision aid, the patient answered the decision-making preference question: "Do you want to choose one of the two treatment options, or do you want to leave the decision to the physician (choose/leave/don't know)?" The patient treatment preference was asked as follows: "Which dose do you prefer (the low dose/the high dose)?" Responses were confirmed 3 days later by telephone; for the decision-making question, the final response options were choose or leave.

Demographic variables and tumor characteristics. We collected self-report data on demographic variables (age, marital status, having [grand]children, working status, education, and religion). Tumor characteristics (T status, pretreatment PSA value, and Gleason score) were extracted from the medical records.

Psychological and well-being variables. The Problem-Solving Decision-Making Scale¹⁹ assessed general decision-making preferences using two questions: "When the risks and benefits of radiotherapy are known to you, (1) who decides how acceptable those risks and benefits are to you, and (2) who decides on the choice?" The response scale ranged from "the doctor alone" (1), to "I alone" (5). The second question was also analyzed separately and used as a baseline decision-making preference. The personality traits autonomy and conscientiousness were assessed with five items each from a shortened version of a personality assessment instrument.²⁰

General health in the previous week was assessed with an 11-point horizontal rating scale ranging from worst imaginable (0) to best imaginable health state (10). Hopelessness, avoidance, and fighting spirit were assessed with the Mental Adjustment to Cancer scale.²¹ Cancer worries were assessed with three questions: "Did you think of prostate cancer last week, did these thoughts affect your mood, and did these thoughts affect your daily activities?"^22,23 Data were obtained on anxiety and depression by means of the Hospital Anxiety and Depression Scale.²⁴ Prostate-specific quality of life was assessed by means of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire PR25 prostate cancer module.²⁵ It contains the following scales: urinary symptoms, bowel symptoms, treatment related adverse effects (bloatedness, hot flashes, edema, weight gain/loss), and sexual functioning.

Knowledge. We asked patients to rate their knowledge (subjective knowledge) on prostate cancer and on the advantages and disadvantages of radiotherapy on a 10-point scale (ranging from "very poor" to "excellent"). Numeracy (ie, the ability to handle basic probability concepts) was assessed with three questions (eg, convert 1 in 1,000 to a percentage).²⁶

Information. Patients were asked to rate their preference for information on a scale ranging from 0 ("I want to know nothing about my illness and treatment") to 10 ("I want to know as much as possible concerning my illness and treatment"). The patients' perception of the amount of information provided on prostate cancer and radiotherapy was rated on a 7-point scale ranging from "far too little information" to "far too much information."

Analysis
Agreement between patients' preferences and physicians' substitute preferences is examined for decision making and treatment preferences separately. Agreement can arise from chance; if one predicts heads all the time, 50% of coin tosses are predicted correctly. A measure correcting for chance agreement is the statistic, ranging from 0 to 1.^27,28 A of 0.2, 0.5, and 0.8 indicates poor, moderate, and good agreement, respectively. In bivariate and multivariate analyses, associations were sought between agreement and the physician variables (eg, years of training and number of patients contributed) and patient variables (eg, demographic, medical, psychological, knowledge and information) described above. In case of missing data, scale values were calculated, if at least half of the items were filled out, by imputing the mean of the remaining items. For bivariate analyses using ² tests, continuous data were dichotomized using the median split. For PSA values, a cutoff of 10 ng/mL was used; for Gleason scores, a cutoff of 7 was used. In addition, anxiety and depression were dichotomized by use of a clinical cutoff point of 8.

Dichotimized variables associated with agreement at a level of P < .20 were included whenever possible as continuous variables in a hierarchical model for binary outcomes (procedure GENMOD; SAS software, version 8.2; SAS Institute, Cary, NC) with agreement as the dependent variable. This model accounted for patients clustering under physicians. Generalized estimating equations estimates were used to test for significance.

	RESULTS

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During the inclusion period, a total of 544 patients came for a consultation. More than 60% of these patients were not eligible because of local or distant metastases (n = 121), previous radical prostatectomy (n = 94), avoidance of external-beam radiotherapy (n = 36), cognitive/mental problems (n = 17), insufficient knowledge of the Dutch language (n = 10), and other reasons (n = 31). The remaining 200 patients were asked to participate in the study. One hundred fifty (75%) of these patients provided informed consent and were included in the study. Patient characteristics are categorized by informed consent in Table 1; the two groups did not differ. Physician characteristics are listed in Table 2. Because both centers were training hospitals, physicians differed in experience and number of patients seen for this study.

	DISCUSSION

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The agreement between physician and patient preferences was poor. This has been observed before.^1-4,29-31 One could argue that the low agreement arises because the clinicians did not discuss the treatment choice with patients. This procedure, however, followed from our research rationale. In practice, physicians may vary information or involvement using their judgment of patient preferences for decision making. The judgment about patient preferences is made before extra information is provided to patients. This study intended to assess the accuracy of such prior judgments. Accordingly, patients' preferences were obtained after decision making was facilitated, and physicians' substitute preferences were measured before decision making was facilitated.

Agreement was not uniformly poor. In more experienced physicians, agreement regarding decision making improved: this is a new finding, and it provides evidence for the claim of older physicians that experience improves their judgments of patients. In more hopeful patients, agreement also improved: this finding is also new and deserves additional interpretation. The rates of patient and substitute preferences in more or less hopeful patients were considered, but could not explain that agreement improves in more hopeful patients. An alternative explanation takes into account communication patterns in less hopeful patients. Less hopeful patients are more anxious and depressed. Such patients utter more concerns, requests, and receive more information, directives, empathy, and longer visits.^32-35 Hence, such patients are more demanding,³⁴ giving physicians less time to judge patient preferences, which in turn leads to a lower agreement.

Other comments can be made. Physicians often believed they were guessing about patients' preferences. They would have preferred to use a "don't know" category while judging patients' decision-making and treatment preferences. "Don't know" responses, unfortunately, can not be analyzed, leading to a loss of valuable data. More importantly, by being forced to guess, some residual agreement might still be detected. In any case, varying the amount of information is a daily routine in clinical practice, so forcing a judgment is not unreasonable. One may argue further that the decision aid is new for physicians, thus confusing their judgment. One should consider, however, that several physicians were involved in the design of the decision aid. All physicians knew the content of the decision aid.

These findings raise concerns about the provision of information and the incorporation of patient preferences in decision making. There are two implications. First, the findings illustrate that physicians need help to determine patient preferences. Physicians can discuss the preferences of the patient, but this is not always common practice. In such a discussion, decision aids may improve agreement³⁶ because they present decision-making information in a format that patients understand, thus helping patients to develop and state their preferences. Second, patients could not foresee their own decision-making preferences. This raises the issue whether decision-making preferences should be obtained before (uninformed preferences) or after (informed preferences) information disclosure. The use of uninformed preferences overlooks the important role information or decision aids play in creating more active patients. Asking patient preferences after having shown a decision aid will satisfy standards for informed consent and patient autonomy.

	AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

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The author(s) indicated no potential conflicts of interest.

	AUTHOR CONTRIBUTIONS

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Conception and design: Peep F.M. Stalmeier, Julia J. van Tol-Geerdink, Emile N.J.Th. van Lin, Henk Huizenga, Willem A.J. van Daal, Jan-Willem Leer

Financial support: Peep F.M. Stalmeier, Henk Huizenga, Willem A.J. van Daal, Jan-Willem Leer

Administrative support: Willem A.J. van Daal, Jan-Willem Leer

Provision of study materials or patients: Julia J. van Tol-Geerdink, Emile N.J.Th. van Lin, Erik Schimmel

Collection and assembly of data: Peep F.M. Stalmeier, Julia J. van Tol-Geerdink

Data analysis and interpretation: Peep F.M. Stalmeier, Julia J. van Tol-Geerdink

Manuscript writing: Peep F.M. Stalmeier, Julia J. van Tol-Geerdink

Final approval of manuscript: Peep F.M. Stalmeier, Julia J. van Tol-Geerdink, Emile N.J.Th. van Lin, Erik Schimmel, Henk Huizenga, Willem A.J. van Daal, Jan-Willem Leer

	NOTES

 
Supported in part by a grant from the Dutch Cancer Society, Amsterdam, the Netherlands (Project No. KUN 2001-2379 and KUN 2005-3457). The funding agreement ensured the authors' independence in designing the study, interpreting the data, and writing and publishing the report. P.F.M.S. and J.J.V.T.-G. are supported by the sponsor.

Presented at the 10th Biennial European Meeting of the Society for Medical Decision Making, June 11-13, 2006, Birmingham, United Kingdom.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical Trials Registry ISRCTN97145188.

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Submitted May 24, 2006; accepted April 20, 2007.

This Article Abstract Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Stalmeier, P. F.M. Articles by Leer, J.-W. Search for Related Content PubMed PubMed Citation Articles by Stalmeier, P. F.M. Articles by Leer, J.-W.