Wilma Otten

Ideals of patient autonomy in clinical decision making: a study on the development of a scale to assess patients’ and physicians’ views

Objectives: Evidence based patient choice seems based on a strong liberal individualist interpretation of patient autonomy; however, not all patients are in favour of such an interpretation. The authors wished to assess whether ideals of autonomy in clinical practice are more in accordance with alternative concepts of autonomy from the ethics literature. This paper describes the development of a questionnaire to assess such concepts of autonomy. Methods: A questionnaire, based on six moral concepts from the ethics literature, was sent to aneurysm patients and their surgeons. The structure of the questionnaire was assessed by factor analysis, and item reduction was based on reliability. Results: Ninety six patients and 58 surgeons participated. The questionnaire consisted of four scales. Two of the scales reflected the paternalistic and consumerist poles of the liberal individualist model, one scale reflected concepts of Socratic autonomy and of procedural independence, and the fourth scale reflected ideals of risk disclosure. Discussion: The Ideal Patient Autonomy Scale is a 14 item normative instrument. It is clearly distinct from the generally used psychological preference questionnaires that assess preferences for physician-patient roles.

Implicit Normativity in Evidence-Based Medicine: A Plea for Integrated Empirical Ethics Research

This paper challenges the traditional assumption that descriptive and prescriptive sciences are essentially distinct by presenting a study on the implicit normativity of the production and presentation of biomedical scientific facts within evidence-based medicine. This interdisciplinary study serves as an illustration of the potential worth of the concept of implicit normativity for bioethics in general and for integrated empirical ethics research in particular. It demonstrates how both the production and presentation of scientific information in an evidence-based decision-support contain implicit presuppositions and values, which pre-structure the moral environment of the clinical process of decision-making. As a consequence, the evidence-based decision support did not only support the clinical decision-making process; it also transformed it in a morally significant way. This phenomenon undermines the assumption within much of the literature on patient autonomy that information disclosure is a conditional requirement before patient autonomy even starts; patient autonomy is already influenced during the production and presentation of information. These results imply an increased responsibility of those who produce and present evidence-based facts(i.e. scientists in general and physicians in particular). The insights of this study not only involve a different focus on both theory and practice of patient autonomy and informed consent, but they also call for a broader scope of morality than does traditional empirical research in bioethics. The concept of implicit normativity within integrated empirical ethics research calls for a strong cooperation between bioethicists and descriptive scientists, i.e., a cooperation that goes beyond the discipline-specific epistemic values and that takes place during all phases of the research process.

Clinical Characteristics Affect the Impact of an Uninformative DNA Test Result: The Course of Worry and Distress Experienced by Women Who Apply for Genetic Testing for Breast Cancer

PURPOSEnDNA mutation testing for breast cancer usually yields an uninformative result, which is a negative result in the absence of a known BRCA mutation within the family. However, few data are available on the psychological impact of this result. Moreover, the clinical heterogeneity within this group has not yet been considered. This study provides prospective data about the course of cancer-specific worry and distress for different groups of test applicants.nnnPATIENTS AND METHODSnAll DNA test applicants (n = 238) completed three questionnaires: before and 1 and 7 months after disclosure of a DNA mutation test. With repeated-measures analysis of variance, differences were assessed between BRCA1/2-positive women (n = 42), BRCA1/2-true-negative women (n = 43), and women with an uninformative test result (n = 153).nnnRESULTSnOn the group level, women with an uninformative result seemed to be reassured after disclosure (P < .001), but to a lesser extent than those women who received a true-negative result. However, not all women with an uninformative result reacted similarly: higher levels of worry and distress could be explained by relatively straightforward clinical variables, namely a personal history of cancer (P < or = .001) and a higher pedigree-based risk (P < or = .005). Furthermore, these clinical variables determined whether these women were either comparable to women who received a true-negative result or to BRCA mutation carriers.nnnCONCLUSIONnWomen with an uninformative result form a heterogeneous group of test applicants. The subpopulation of those with both a personal history of cancer and a relatively high pedigree-based risk expressed the highest levels of worry 7 months after DNA testing.

Review of Determinants of Patients' Preferences for Adjuvant Therapy in Cancer

PURPOSEnMany studies have determined cancer patients preferences for adjuvant therapy, for example, by asking patients the extent of benefit they would need in order to accept the therapy. However, little is known about the determinants that influence these preferences. Our research goal was to explore which determinants underlie patients preferences by means of a literature review.nnnMETHODSnPubMed searches were conducted to identify studies in which cancer patients preferences for adjuvant therapy had been elicited by means of a treatment preference instrument. Twenty-three papers were evaluated with regard to reported relationships between preferences and potential determinants. A total of 40 determinants were recorded and classified into one of seven categories: (1) treatment-related determinants, (2) sociodemographic characteristics and current quality of life, (3) clinical characteristics, (4) measurement instrument-related determinants, (5) time-related determinants, (6) cognitive/affective determinants, and (7) specialist-related determinants.nnnRESULTSnThe benefit and toxicity of treatment, experience of the treatment, and having dependents (eg, children) living at home were important determinants of patients preferences. Furthermore, qualitative data suggested that cognitive/affective and specialist-related determinants might have a large impact on patients treatment preferences.nnnCONCLUSIONnOur results show that patients preferences cannot fully be explained on the basis of treatment-related determinants and patient and clinical characteristics. More research is needed in the area of cognitive/affective and specialist-related determinants because of the lack of quantitative results. Furthermore, we recommend carrying out larger studies in which the (internal) relationships between determinants and preferences are assessed in the context of a cognitive cost-benefit model.

Decision Making Regarding Prophylactic Mastectomy: Stability of Preferences and the Impact of Anticipated Feelings of Regret

PURPOSEnWomen who test positive for a BRCA1/2 mutation face difficult choices to manage their breast cancer risk; one of these choices is whether to opt for prophylactic mastectomy. Few data are available about this decision-making process. The current study provides data regarding the stability of risk-management preferences over time and the factors that are associated with these preferences.nnnPATIENTS AND METHODSnWe analyzed data from 338 women who opted for breast cancer antigen (BRCA) testing. First, we prospectively assessed preferences of 80 BRCA mutation carriers at five different points in time ranging from 1 week after blood sampling up to 9 months after BRCA-test disclosure. Second, we applied univariate and multivariate regression analyses to examine which medical, sociodemographic, and psychological factors are related to a preference for prophylactic mastectomy.nnnRESULTSnNinety percent of the women already indicated a preference regarding risk management at baseline. Moreover, most women had stable preferences over time. Furthermore, anticipated feelings of regret in case of a hypothetical breast cancer diagnosis in the near future were strongly related to risk-management preference (odds ratio = 8.93; P < .0001).nnnCONCLUSIONnWomen seem to decide at a relatively early stage about their risk-management preferences. Many of them may be sensitive to the possibility of regret in case of a bad outcome. We discuss whether possible regret in the future is a rational reason for opting for prophylactic mastectomy, or whether it signifies an emotional coping process or strategy in which the future costs are no longer fully considered.

Choosing a Hospital for Surgery: The Importance of Information on Quality of Care

Objective. To assess whether patients use information on quality of care when choosing a hospital for surgery compared with more general hospital information. Methods. In this cross-sectional study in 3 Dutch hospitals, questionnaires were sent to 2122 patients who underwent 1 of 6 elective surgical procedures in 2005—2006 (aorta reconstruction [for treatment of aneurysm], cholecystectomy, colon resection, inguinal hernia repair, esophageal resection, thyroid surgery). Patients were asked which information they had used to choose this hospital and which information they intended to use if they would need similar surgical treatment in the future. Results. In total, 1329 questionnaires were available for analysis (response rate 62.6%). Most patients indicated having used the hospital’s good reputation (69.1%) and friendly hospital atmosphere (63.3%) to choose a hospital. For future choices, most patients intended to use the fact that they were already treated in that hospital (79.3%) and the hospital’s good reputation (74.1%). Regarding quality-of-care information, patients preferred a summary measure (% patients with ‘‘textbook outcome’’) over separate more detailed measures (52.1% v. 38.0%, χ2 = 291, P < 0.01). For future choices, patients intend to use more information items than in 2005—2006, both in absolute terms (9 v. 4 items, t = 38.3, P < 0.01) as relative to the total number of available items (41.3% [40.1%—42.5%] v. 29.2% [28.1%—30.2%]). Conclusion. Patients intended to use more information for future choices than they used for past choices. For future choices, most patients prefer a summary measure on quality of care over more detailed measures but seem to value that they were already treated in that hospital or a hospital’s good reputation even more.

What's the message? Interpretation of an uninformative BRCA1/2 test result for women at risk of familial breast cancer

Purpose: To test the “false-reassurance hypothesis,” which suggests that women who receive an uninformative BRCA1/2 test result may incorrectly conclude that they no longer have an elevated risk, with possible harmful consequences for adherence to breast surveillance guidelines.Methods: A prospective questionnaire design was used to compare 183 women with an uninformative BRCA test result (94 affected and 89 unaffected) with 41 proven BRCA mutation-carriers and 49 true negatives before and after BRCA1/2 test disclosure.Results: After DNA-test disclosure, test applicants differed from each other with regard to their perception of the likelihood of carrying a deleterious gene (P < 0.0001). The BRCA mutation carriers reported the highest perceived likelihood and the true negatives reported the lowest. Compared to the predisclosure measures, women who received an uninformative DNA test result reported a lower perceived risk after disclosure (P < 0.0001), suggesting a relatively high level of reassurance because of the test result. However, after DNA-test disclosure, only 12 women concluded that the risk of carrying a mutation was nonexistent, and perceived likelihood was significantly associated with the pedigree-based risk assessment (P = 0.0001). Moreover, despite the significant decrease in perceived likelihood for uninformative women, intention to obtain mammograms did not change (P = 0.71); it remained at the same almost optimal level as for BRCA mutation carriers.Conclusion: No support was found for the suggestion that the nature of uninformative test results is often misunderstood. Moreover, an uninformative test result did not affect the positive mammography intentions of both affected and unaffected women.

The impact of the perception of treatment choice on satisfaction with treatment, experienced chemotherapy burden and current quality of life

Previous research has shown that involving patients in the decision-making process may improve their quality of life (QoL). Our purposes were to assess: (1) whether early-stage breast cancer patients perceived that they had treatment choice with regard to adjuvant chemotherapy, (2) what reasons patients provide for their perception of having had no choice of treatment and (3) whether the perception of treatment choice is related to satisfaction with the assigned treatment, experienced chemotherapy burden and current QoL. A total of 448 patients, treated between 1998 and 2003, filled in the questionnaire (response rate: 62%). Patients who indicated that they had not perceived a choice regarding chemotherapy could tick off one or more reasons out of 10 reasons, or provide their own reason(s). Quality of life was measured on a Visual Analogue Scale, by means of the EuroQol, and by means of the Hospital Anxiety and Depression Scale. Of the 405 patients who had answered the question on treatment choice, 316 patients (78%) had perceived no choice. The most frequently indicated reason for lack of choice was: ‘I follow the doctors advice.’ We found no differences in the levels of satisfaction with assigned treatment and in how much of a burden they found chemotherapy between patients who perceived a choice of treatment and those who did not. In general, the perception of choice seemed to have no impact on QoL. However, we found an interaction effect, which indicated that the impact of perception of treatment choice on QoL was dependent upon whether the patient had been treated with chemotherapy or not. Within the group of patients who had not been treated with chemotherapy, the perception of having had a choice was related to lower current QoL. In cases when the decision to be treated or not has potential consequences for the chance of survival, patients QoL may not be improved by the perception of having had a choice of treatment.

The Relative Importance of Quality of Care Information When Choosing a Hospital for Surgical Treatment: A Hospital Choice Experiment

Objective: To assess the impact of quality of care and other hospital information on patients’ choices between hospitals. Methods: 665 former surgical patients were invited to respond to an Internet-based questionnaire including a choice-based conjoint analysis. Each patient was presented with 12 different comparisons of 2 hospitals, with each hospital characterized by 6 attributes containing 2 levels. Hospital attributes were included if frequently reported by patients as most important for future hospital choices. These included both general hospital information (e.g., atmosphere), information on quality of care (e.g., percentage of patients with “textbook outcome”), and surgery-specific information (e.g., possibility for minimally invasive procedure). Hierarchial Bayes estimation was used to estimate the utilities for each attribute level for each patient. Based on the ranges of these utilities, the relative importance of each hospital attribute was determined for each participant as a measure of the impact on patients’ choices. Results: 308 (46.3%) questionnaires were available for analysis. Of the hospital attributes that patients considered, surgery-specific information on average had the highest relative importance (25.7 [23.9–27.5]), regardless of gender, age, and education. Waiting time and hospital atmosphere were considered least important. The attribute concerning the percentage of patients with “textbook outcomes” had the second greatest impact (18.3 [16.9–19.6]), which was similar for patients with different adverse outcome experience. Conclusions: Surgery-specific and quality of care information are more important than general information when patients choose between hospitals.

How important is the opinion of significant others to cancer patients’ adjuvant chemotherapy decision-making?

GoalsDecisions regarding adjuvant chemotherapy are difficult, since value tradeoffs are involved. Little is known about the importance of the significant others in patients’ decision-making regarding adjuvant treatment. We surveyed patients with breast and colorectal cancer about the importance they assigned to the opinions of their significant others and assessed correlates of these importance scores.Materials and methodsOne hundred and twenty-three patients rated on a five-point scale how much they cared about the opinion of six significant others.Main resultsMost important was the opinion of their treating specialist, followed by that of their partner, children, other family, friends, and colleagues. Women assigned higher scores to the opinion of their children, younger patients to that of their specialist, and patients who were about to undergo chemotherapy to that of their family. Patients with breast cancer and patients without paid employment assigned slightly more importance to the opinion of their partner.ConclusionsInformation on the influence of significant others may help clinicians when involving patients in treatment decision-making and discussing patients’ treatment preferences.