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This increase has been the result of several recent developments. Within Western societies after the Second World War, there has been room for more than simply combating poverty and saving the lives of people. In addition, an amelioration of the well-being of the population was put on the political agenda. Likewise, health care budgets became available not only to cure patients but also to pay for their well-being. This was not a problem as long as these budgets seemed unlimited. However, they have become tighter over the last few years. Thus, while the demand for health care was almost endless and technology expanded further, it became necessary to investigate whether interventions really had a positive effect for patients in terms of health along with cure or survival. Developments have also occurred from the patients’ point of view. Patients have become more conscious consumers of health care. Now they often want, and in many countries have the legal right, to know what is happening to them. Quality-of-life research was done most often, originally, to describe the impact of disease and treatment. Collected data were meant to enhance insight into patients’ lives. As a result, patient information could become more accurate and care could be ameliorated. However, apart from the description of effects, the developments outlined above necessitate decision making to be more explicit. Limited budgets have to be used in an optimal way. As a result, governments have stressed the importance of substantiating choices by studying and comparing the effectiveness or cost-effectiveness of medical interventions. Likewise, patients not only want to know, but also want to participate in decision making by weighing the advantages and disadvantages of the available treatment options. Thus, quality-of-life data have become important in supporting the decision-making process. Research on patients’ quality of life and on decision making is particularly

Healthcare decisions, particularly those involving weighing benefits and harms that may significantly affect quality and/or length of life, should reflect patients' preferences. To support patients in making choices, patient decision aids and values clarification methods (VCM) in particular have been developed. VCM intend to help patients to determine the aspects of the choices that are important to their selection of a preferred option. Several types of VCM exist. However, they are often designed without clear reference to theory, which makes it difficult for their development to be systematic and internally coherent. Our goal was to provide theory-informed recommendations for the design of VCM. Process theories of decision making specify components of decision processes, thus, identify particular processes that VCM could aim to facilitate. We conducted a review of the MEDLINE and PsycINFO databases and of references to theories included in retrieved papers, to identify process theories of decision making. We selected a theory if (a) it fulfilled criteria for a process theory; (b) provided a coherent description of the whole process of decision making; and (c) empirical evidence supports at least some of its postulates. Four theories met our criteria: Image Theory, Differentiation and Consolidation theory, Parallel Constraint Satisfaction theory, and Fuzzy-trace Theory. Based on these, we propose that VCM should: help optimize mental representations; encourage considering all potentially appropriate options; delay selection of an initially favoured option; facilitate the retrieval of relevant values from memory; facilitate the comparison of options and their attributes; and offer time to decide. In conclusion, our theory-based design recommendations are explicit and transparent, providing an opportunity to test each in a systematic manner.Highlights► Patient decision aids often include a method to help patients clarify how important they judge healthcare options or their attributes. ► Psychological theories on decision making identify the processes that assist value-consistent decision making. ► Based on theories we propose, for example, encouraging consideration of all appropriate options and facilitating the weighing of their attributes. ► Our recommendations advance transparent and coherent VCM design and evaluation.Keywords: Decision making process, Preferences, Decision aid, Mental representation, Choice, Literature review

Despite multimodal treatment with surgery, radiotherapy and chemotherapy, glioblastoma is an incurable disease with a poor prognosis. During the disease course, glioblastoma patients may experience progressive neurological deficits, symptoms of increased intracranial pressure such as drowsiness and headache, incontinence, seizures and progressive cognitive dysfunction. These patients not only have cancer, but also a progressive brain disease. This may seriously interfere with their ability to make their own decisions regarding treatment. It is therefore warranted to involve glioblastoma patients early in the disease trajectory in treatment decision-making on their future care, including the end of life (EOL) care, which can be achieved with Advance Care Planning (ACP). Although ACP, by definition, aims at timely involvement of patients and proxies in decision-making on future care, the optimal moment to initiate ACP discussions in the disease trajectory of glioblastoma patients remains controversial. Moreover, the disease-specific content of these ACP discussions needs to be established. In this article, we will first describe the history of patient participation in treatment decision-making, including the shift towards ACP. Secondly, we will describe the possible role of ACP for glioblastoma patients, with the specific aim of treatment of disease-specific symptoms such as somnolence and dysphagia, epileptic seizures, headache, and personality changes, agitation and delirium in the EOL phase, and the importance of timing of ACP discussions in this patient population.

Objectives: One of the explanations for the difference between health state utilities elicited from patients and the public—often provided but seldom studied—is adaptation. The influence of adaptation on utilities was investigated in patients with spinal cord injury. Methods: Interviews were held at 3 time points (T1, after admission to the rehabilitation center; T2, during active rehabilitation; T3, at least half a year after discharge). At T1, 60 patients were interviewed; 10 patients withdrew at T2 and T3. At all time points, patients were asked to value their own health and a health state description of rheumatoid arthritis on a time trade-off and a visual analogue scale. The Barthel Index, a measure of independence from help in activities of daily living, and the adjustment ladder were filled out. Main analyses were performed using mixed linear models taking the time-dependent covariates (Barthel Index and adjustment ladder) into account. Results: Time trade-off valuations for patients’ own health changed over time, even after correction for gain in independence from help in activities of daily living, F(2, 59) = 8.86, P < 0.001. This change was related to overall adaptation. Both a main effect for adaptation, F(87, 1) = 10.05; P = 0.002, and an interaction effect between adaptation and time, F(41, 1)= 4.10, P = 0.024, were seen for time trade-off valuations. Valuations given for one’s own health on the visual analogue scale did not significantly change over time, nor did the valuations for the hypothetical health state. Conclusion: Patients’ health state valuations change over time, over and above the change expected by the rehabilitation process, and this change is partly explained by adaptation. Experience with a chronic illness did not lead to change in valuations of hypothetical health states.

Background The aim of our study was to investigate anticipated adaptation among patients in the subacute phase of Spinal Cord Injury (SCI). Methods We used an observational longitudinal design. Patients with SCI (N = 44) rated their actual, previous and expected future Quality of Life (QoL) at three time points: within two weeks of admission to the rehabilitation center (RC), a few weeks before discharge from the RC, and at least three months after discharge. We compared the expected future rating at the second time point with the actual ratings at the third time point, using student’s t-tests. To gain insight into scale recalibration we also compared actual and previous ratings. Results At the group level, patients overpredicted their improvement on the VAS. Actual health at T3(M = 0.65, sd =0.20)) was significantly lower than the predicted health at T1 of T3 (M = 0.76, sd = 0.1; t(43) = 3.24, p

Health related quality of life (HRQoL) of living kidney donors on average is good, but some donors experience a low HRQoL after donation. This study assessed the prevalence of reduced HRQoL and explored associations with pre- and post-donation variables. 316 donors (response rate 74%) who donated a kidney between 1997 and 2009 filled in a questionnaire. HRQoL was measured using the Short-Form 36; fatigue using the Multidimensional Fatigue Inventory; societal participation using the Utrecht Scale for Evaluation of Rehabilitation-Participation. Donors on average had better HRQoL than the general population. However, 12% had a reduced physical (PCS) and 18% a reduced mental (MCS) HRQoL. Donors with reduced HRQoL reported greater fatigue (P0.01), lower societal participation (P0.01) and showed a trend towards statistical significance in experiencing more donor-recipient relationship changes (P = 0.07). Prior to donation, donors with reduced PCS had a higher BMI (P0.05) and more often smoked (P0.05). Donors with reduced MCS had higher expectations (P0.05). Reduced HRQoL is associated with higher BMI, smoking and higher expectations prior to donation. These results may be used to develop a screening instrument to select donors at high risk for reduced HRQoL.

Introduction Cost-effectiveness is an important criterion in the decision to cover interventions in health insurance packages. One of the outcome measures, the quality-adjusted life year, has been criticised on its assumptions and implications concerning life expectancy and quality of life. Several studies have been conducted that measured societal preferences concerning healthcare rationing decisions. These studies mainly focused on one attribute. To adjust quality-adjusted life year maximisation in accordance with societal preferences, the relative importance of attributes should be studied. The present study aims to measure the relative importance of age, gender, socioeconomic status, pre-intervention health state, treatment effect, chance of treatment success and number of people in need of the intervention. A secondary objective is to compare the validity of the willingness to pay method with the validity of a relatively new preference elicitation method, best–worst scaling. Methods and analysis A representative sample of 2000 Dutch citizens, over 18 years of age, are recruited to complete a web-based survey containing treatment scenarios. The scenarios present different levels of attributes. Respondents are asked to select one of the four scenarios that they prefer to be covered by the Dutch standard health insurance package and one that they prefer not to be covered. They are also asked to indicate how much they are willing to pay for each treatment scenario. At the end of the survey, respondents are asked to rate every attribute on a 1–10 scale. Two versions of the questionnaire are developed which differ on the framing, that is, treatments can be added to or removed from the insurance package. The data will be analysed by means of sequential conditional logit analysis (best–worst scaling) and analysis of variance (willingness to pay). Ethics and dissemination The protocol is reviewed and approved by the medical ethical committee of the University Medical Center Leiden., Article summary Article focus How do people value different attributes relative to other attributes in the context of healthcare resource allocation decisions? How does the validity of the best–worst scaling method compare with the willingness pay method?

Objective: To test the applicability of multi-criteria decision analysis preference elicitation techniques in cognitively impaired individuals. Method: A convenience sample of 16 cognitively impaired subjects and 12 healthy controls was asked to participate in a small pilot study. The subjects determined the relative importance of four decision criteria using five different weight elicitation techniques, namely simple multi-attribute rating technique, simple multi-attribute rating technique using swing weights, Kepner-Tregoe weighting, the analytical hierarchical process, and conjoint analysis. Results: Conjoint analysis was judged to be the easiest method for weight elicitation in the control group (Z = 10.00; p = 0.04), while no significant differences in difficulty rating between methods was found in cognitively impaired subjects. Conjoint analysis elicitates weights and rankings significantly different from other methods. Subjectively, cognitively impaired subjects were positive about the use of the weight elicitation techniques. However, it seems the use of swing weights can result in the employment of shortcut strategies. Conclusion: The results of this pilot study suggest that individuals with mild cognitive impairment are willing and able to use multi-criteria elicitation methods to determine criteria weights in a decision context, although no preference for a method was found. The same methodologic and practical issues can be identified in cognitively impaired individuals as in healthy controls and the choice of method is mostly determined by the decision context.

Item does not contain fulltext Although many clinicians feel they already use shared decision making, research shows a perception-reality gap. A M Stiggelbout and colleagues discuss why it is important and highlight some best practices.

Objective: Previous studies suggest that learning a DNA-test-result has no direct impact on the medical-decisions and psychological well-being of counselees. Their perception, especially their recollections and interpretations of their cancer-risks and heredity, predict and/or mediate this impact. These studies were criticized for their small range of predictors, mediators, outcomes and contextual factors. We studied the short-term impact of DNA-testing with an extended model.Methods: Three months after disclosure of BRCA1/2-test-results, we sent counselees a questionnaire about their perception, medical and psychological outcomes, and medical, familial and psychological contexts. 248 affected women participated: 30 had received pathogenic-mutations, 16 unclassified-variants and 202 uninformative-results.Results: The actually communicated genetic-information and the contextual variables predicted the counselees' perception, but did not directly predict any outcomes. The counselees' perception predicted and/or completely mediated the counselees' medical intentions and behavior, physical and psychological life-changes, stigma, mastery, negativity and cancer-worries. Short-term distress was related to the perception not only of their own risks, but also of their relatives' risks and heredity-likelihood. Effect sizes were medium to large.Conclusions and implications: The outcomes of DNA-testing were better predicted by the counselees' perception than by the actually given genetic-information. We recommend genetic-counselors to have tailored, interactive dialogues about the counselees' perception. (C) 2011 Elsevier Ireland Ltd. All rights reserved.

Mevrouw De Roos, 32 jaar, werkt achter de schermen in haar eigen restaurant. Ik ben haar huisarts. Zij komt op mijn spreekuur om voor de zoveelste keer een oplossing te vinden voor haar overgewicht. Zij is een kleine, maar omvangrijke vrouw: 1 meter 68 lang en 108 kilo. Zij geneert zich voor haar uiterlijk en mijdt daarom zoveel mogelijk dat altijd zo gezellige contact met haar klanten. Zij mist die babbeltjes enorm en voelt zich sociaal geisoleerd.

Medical treatment of cancer often entails a trade-off between outcomes of two different attributes: quality of life (QOL) and length of life (LL). This process of weighing advantages and disadvantages seems to be influenced by different factors. The main purposes of this study were (a) to investigate the relative importance of different factors on the trade-off and (b) to explore the relationship between these importance ratings and personal characteristics. We asked 199 patients with cancer to indicate to what degree they consider a number of factors to be of importance if they had to choose between two treatment modalities that differ in their expected outcomes concerning QOL and LL. The seven factors were their age at the time of decision, having a partner, having children, inability to work due to side-effects of the treatment, the nature of the side-effects, disease-related life expectancy and baseline QOL. The results indicate that six of the seven factors were of considerable to great importance when a treatment choice had to be made. The negative effects of treatment on the ability to work did not seem to be a very important consideration. Patient age and education were positively associated with importance ratings.

OBJECTIVE: The authors sought to determine whether intensive follow-up improves 5-year survival rates in patients with colorectal cancer who were operated on for cure. SUMMARY BACKGROUND DATA: Intensive follow-up of patients with colorectal cancer is still controversial. The present uncertainty in regard to the value of intensive follow-up could be the result of the absence of prospective randomized studies comparing patients with and without follow-up. METHODS: Studies comparing two follow-up programs of different intensities were identified in the medical literature and were aggregated in a meta-analysis using the "random effects method." Seven nonrandomized studies describing 3283 patients were analyzed. RESULTS: Patients with intensive follow-up did have 9% better 5-year survival rates than did those with minimal or no follow-up, only when intensive follow-up included carcinoembryonic antigen (CEA) assays. In addition, more asymptomatic recurrences were detected and more recurrences were resected in patients with intensive follow-up. CONCLUSIONS: This meta-analysis indicated that intensive follow-up using CEA assays can identify treatable recurrences at a relatively early stage. Treatment of these recurrences appears to be associated with improved 5-year survival rates. However, not all intensive follow-up strategies will be equally effective. Follow-up may yield the best results if diagnostic tests are used only to detect those recurrences that can be operated on with curative intent and when follow-up is "individualized," according to patient characteristics.

The standard gamble (SG) and the time tradeoff (TTO), two frequently used methods of utility assessment, have often been found to lead to different utilities for the same health state. The authors investigated whether adjustment of TTO scores for the utility of life years (risk attitude) eliminated this difference. In addition, the association between risk attitude and sociodemographic and medical variables was studied. In 30 disease-free testicular cancer patients, SG and TTO were used to assess the utilities of four health profiles relevant to testicular cancer. Utility of life years was estimated from certainty equivalents (CEs). SG scores were significantly higher than unadjusted TTO scores for all profiles. As the majority of patients (85%) were risk-averse, CE-adjusted TTO scores were higher than unadjusted scores, and were not significantly different from those obtained from the SG for three of the four profiles. However, adjusted scores were still slightly but consistently lower than SG scores. Possible explanations for this discrepancy are discussed. An association was found between risk aversion and medical treatment: patients who had received chemotherapy for their cancers were more risk-averse than were patients who had been in a surveillance protocol only. As risk aversion can have an impact on treatment decisions, it is important to assess the risk posture of the patient to whom the decision pertains. Key words: utility assessment; QALY; risk aversion; oncology; treatment preferences. (Med Decis Making 1994;14:82-90)

Adjuvant treatments can be added to primary curative cancer treatments to increase the probability of survival. However, these treatments have side effects. Research into what additional probability of survival cancer patients require from an adjuvant treatment before they consider it worthwhile, has been carried out in hypothetical situations. The published literature on this subject shows that the additional benefit which patients expect is small. Yet, variation in patient preferences within studies is large. Preferences regarding additional benefit are not consistently associated with patient socio-demographic or disease characteristics. It is very likely that new patients who face the choice of adjuvant treatment will greatly differ from each other in the benefit that they require from it. In order to give individualized recommendations, specialists need to ask the patient which benefits and disadvantages he or she considers to be important.

Study Objectives: To compare preferences for laparoscopic hysterectomy (LH) over abdominal hysterectomy (AH) by gynecologists who perform LH (group 1), their colleagues (group 2), and gynecologists employed by a hospital that does not provide LH (group 3), and to estimate boundary values of patient characteristics that influence preference for mode of hysterectomy. Differences in referral tendencies between groups 2 and 3 are compared. Design: Group comparison study (Canadian Task Force classification II-2). Setting: Nationwide conjoint preference study in groups 1, 2, and 3. Intervention: Web-based choice-based conjoint analysis questionnaire. Measurements and Main Results: In general, group I preferred LH significantly more often (86.3%; 95% confidence interval [Cl], 81.6-91.0) than did group 2 (70.9%; 95% CI, 63.4-78.4). Group 3 preferred LH significantly less frequently (50.3%; 95% CI, 35.7-64.9). Increases in body mass index, estimated uterus size, and number of previous abdominal surgeries caused a significant drop in shares of preferences in all groups. Conclusions: The presence of a gynecologist who performs LH positively influences the referral behavior of colleagues. The effect of an increased body mass index seems to be a restrictive parameter for choosing LH according to both referring gynecologists and those who perform LH. Level of experience does not influence preference of laparoscopists. The observed discrepancy between reported and simulated referral behavior in group 3 demonstrates that practical impediments significantly decrease referral tendencies, consequently hampering implementation of this minimally invasive approach. Journal of Minimally Invasive Gynecology (2011) 18, 582-588 (C) 2011 AAGL. All rights reserved.

Background: Unclassified variant and uninformative BRCA1/2 results are not only relevant for probands to whom results are disclosed but also for untested relatives. Previous studies have seldomly included relatives and have not explained how their lives were influenced by these results. We explored the family communication timeline of genetic counseling: (1) genetic counselors communicate the relatives' cancer risk, (2) probands perceive this risk and (3) communicate this to relatives; (4) relatives perceive this information, and (5) experience an impact on their lives. Methods: We conducted a retrospective descriptive study in 13 probands with an unclassified variant and 5 with an uninformative result, and in, respectively, 27 and 12 of their untested female relatives from moderate cancer risk families. In questionnaires, probands described their perception of the DNA-test result (i.e., recollections and interpretations of cancer risks and heredity likelihood). Relatives described the communication process, their perception, and impact (i.e., medical decisions, distress, quality of life, and life changes). Bootstrap analysis was used to analyze mediation effects. Results: The relatives' own perception strongly predicted breast self-examination, breast/ovarian surveillance or surgery, levels of distress and quality of life, and amount of reported life changes. The extent to which the proband had communicated the DNA-test result in an understandable, direct, reassuring way, predicted the relatives' perception. The actual communicated relatives' cancer risks or the proband's perception did not predict relatives' perception and impact measures. Family characteristics influenced the communication process but not the relatives' perception and outcomes. Discussion: Relatives seem to make poorly informed decisions on the basis of their own perception, which was unrelated to the information that probands had communicated on the basis of the actual communicated result. Therefore, genetic counselors may guide probands in the communication process and may directly inform relatives, if possible. Genet Med 2011:13(4):333-341.

Objective of this paper is to study how DNA-test result information was communicated and perceived within families. A retrospective descriptive study in 13 probands with a BRCA1/2 unclassified variant, 7 with a pathogenic mutation, 5 with an uninformative result, and in 44, 14, and 12 of their 1st and 2nd degree relatives respectively. We examined differences and correlations between: (a) information actually communicated (b) probands' perception, (c) relatives' perception. The perception consisted of recollections and interpretations of both their own and their relatives' cancer-risks, and heredity-likelihood (i.e. likelihood that cancer is heritable in the family). Differences and low correlations suggested few similarities between the actually communicated information, the probands' and the relatives' perception. More specifically, probands recalled the communicated information differently compared with the actually communicated information (R = .40), and reinterpreted this information differently (R = .30). The relatives' perception was best correlated with the proband's interpretation (R = .08), but this perception differed significantly from their proband's perception. Finally, relatives reinterpreted the information they received from their proband differently (R = .25), and this interpretation was only slightly related with the original message communicated by the genetic-counsellor (R = .15). Unclassified-variants were most frequently misinterpreted by probands and relatives, and had the largest differences between probands' and relatives' perceptions. Like in a children's whisper-game, many errors occur in the transmission of DNA-test result information in families. More attention is required for how probands disseminate information to relatives. Genetic-counsellors may help by supporting the probands in communicating to relatives, e.g. by providing clear summary letters for relatives.

To provide insight into professionals' opinions on breast cancer follow-up to facilitate implementation of new follow-up strategies. The study focuses on current practice, purpose and perceived effects, and preferred frequency and duration of follow-up.A 29-item questionnaire on professionals' demographics, current practice, opinion on the current guideline, preferences in frequency and duration of tailored follow-up, and the purpose and perceived effects of follow-up was sent to 633 Dutch professionals.The current national guideline is followed by 81% of respondents. All different specialists are involved in follow-up. Sixty-nine percent of respondents' report nurse practitioners to be involved in follow-up. When asked for tailored follow-up, professionals indicate more factors for increased follow-up (age40 years, pT3-4 tumour, pN2-3, treatment related morbidity, and psychosocial support), than for reduced schedules (age70 years and DCIS histology). Alternative forms of follow-up are not endorsed by90% of respondents. Detection of a new primary tumour of the breast is considered the most important purpose of follow-up (98%), 57% still indicates detecting metastases as a goal.Professionals tend towards longer and more intensive follow-up than the current guideline for a large group of patients. Limitations and developments in follow-up need to be considered to facilitate alternative follow-up strategies.

Patients tend to assign higher utilities to health states compared with the general public. Several explanations have been given for this difference including focusing illusion -, caused in part by the sparseness of a health state description such as the EQ-5D -, and adaptation.We investigated whether patients and the public differ in which dimensions they find important. Furthermore, we compared whether the dimensions named by patients and the public obtained higher rankings of importance compared with the predefined EQ-5D dimensions. Within each nominated dimension we investigated whether the public used a more negative frame compared with patients. In addition, adaptation was investigated by comparing patients with high levels of adaptation and patients with low levels of adaptation.Data were collected using semistructured interviews among 124 patients with rheumatoid arthritis and 64 members of the public. Participants indicated which aspects are important to them when they think about their life having rheumatoid arthritis and rated the importance of these aspects and of the EQ-5D dimensions.In contrast to patients, the public named more often aspects related to sports and mobility, leisure activities and work and framed these aspects negatively. Compared with self-rated dimensions, the public ranked the EQ-5D dimensions as more important whereas patients found both groups of aspects equally important. Patients who showed higher levels of adaptation did not differ significantly from patients with lower levels.The public is focused on life domains that are negatively influenced by the described health state whereas patients are focused on both the positive and negative aspects of their lives.

Many cancer-patients undergo DNA testing in the BRCA1/2 genes to receive information about the likelihood that cancer is heritable. Previous nonsystematic studies suggested that DNA testing often does not fulfill the counselees' needs for certainty. We explored the balance between the counselees' need for certainty and perceived certainty (NfC-PC, i.e., level of fulfillment of NfC) regarding the specific domains of DNA test result, heredity and cancer. We also examined relationships of NfC-PC with coping styles and distress.Before disclosure of BRCA1/2 test results for hereditary breast/ovarian cancer (T1), questionnaires were filled in by 467 cancer-patients. Another questionnaire (T2) was filled in after disclosure of pathogenic mutation results (n = 30), uninformative results (n = 202) or unclassified-variants (n = 16).Before and after DNA test result disclosure, overall 58-94% of all counselees experienced unfulfilled NfC regarding the DNA test result, heredity and cancer. Compared with T1, the communication of pathogenic mutations (T2) caused more fulfillment of the NfC about the DNA test result, but less about cancer and heredity (p.01). Compared with T1, unclassified variants (T2) did not significantly change the extent of fulfillment of all counselees' needs for certainty (NfCPC). Compared with T1, uninformative results (T2) caused more fulfillments of all needs than before disclosure (p0.01). Counselees differentiated NfC and PC between the domains of DNA-test result, heredity and cancer (p0.01). The unfulfilled needs for certainty (NfC-PC) were uncorrelated with cognitive understanding of the DNA test result.The counselees' NfC needs more attention in research and practice, for example, when the potential uncertainties of testing are discussed. The counselees' NfC may be assessed and used in tailored, mutual communication of DNA test results.

Item does not contain fulltext WHAT ABOUT POLICY REGARDING SDM? The Dutch health care system has been reformed in 2006 to make it more patient-oriented and demand-driven. We shortly describe four strategies of this health care reform. Although research projects are now fully spread over the country, a coordinated research agenda on SDM is lacking. WHAT ABOUT TOOLS - DECISION SUPPORT FOR PATIENTS? The Dutch governmental healthcare internet portal for patients hosts 16 patient decision aids. WHAT ABOUT PROFESSIONAL INTEREST AND IMPLEMENTATION? There is quite a strong patient participation movement in the Netherlands, on macro and meso level. Limited effort, related to the local research projects has been put into training professionals in SDM skills. WHAT DOES THE FUTURE LOOK LIKE? We need concerted action on the level of educating health care professionals, empowering patients, making patient decision aids easily accessible, supporting the professionals in this new task, and measuring the process of SDM in performance indicators used in quality assurance. The Dutch Platform for SDM that will be launched in Maastricht in June 2011 is therefore a timely and relevant initiative.

Vos J, Oosterwijk JC, Gómez-García E, Menko FH, Jansen AM, Stoel RD, van Asperen CJ, Tibben A, Stiggelbout AM. Perceiving cancer-risks and heredity-likelihood in genetic-counseling: how counselees recall and interpret BRCA 1/2-test results. Previous studies on the counsellees' perception of DNA test results did not clarify whether counsellees were asked about their recollections or interpretations, and focused only on patients' own risks and not on the likelihood that cancer is heritable in the family. We tested differences and correlations of four perception aspects: recollections and interpretations of both cancer risks and heredity likelihood. In a retrospective study, women tested for BRCA1/2 on average, 5 years ago, completed questionnaires about their perception. Participants had received an unclassified variant (n = 76), uninformative (n = 76) or pathogenic mutation (n = 51) result in BRCA1/2. Analyses included t-tests, correlations and structural equation modelling. The counsellees' perception showed to consist of four distinctive phenomena: recollections and interpretations of cancer risks and of heredity likelihood. This distinctiveness was suggested by significant differences between these perception variables. Moderate to strong correlations were found between these variables, suggesting that these differences between variables were consistent. The relationships between these variables were not influenced by actually communicated DNA test results, sociodemographics, medical and pedigree information, or framing of cancer risk questions. The largest differences between recollections and interpretations were found in the unclassified variant group and the smallest in uninformatives. Cancer risks and heredity likelihood correlated least in the pathogenic mutation group. Communication of ambiguous genetic information enlarged the differences. To understand the counsellees' perception of genetic counselling, researchers should study recollections and interpretations of cancer risks and heredity likelihood. Genetic counsellors should explicitly address the counsellees' recollections and interpretations, and be aware of possible inaccuracies.

Background In cost-utility analyses gain in health can be measured using health state utilities. Health state utilities can be elicited from members of the public or from patients. Utilities given by patients tend to be higher than utilities given by members of the public. This difference is often suggested to be explained by adaptation, but this has not yet been investigated in patients. Here, we investigate if, besides health related quality of life (HRQL), persons' ability to adapt can explain health state utilities. Both the direct effect of persons' adaptive abilities on health state utilities and the indirect effect, where HRQL mediates the effect of ability to adapt, are examined. Methods In total 125 patients with Rheumatoid Arthritis were interviewed. Participants gave valuations of their own health on a visual analogue scale (VAS) and time trade-off (TTO). To estimate persons' ability to adapt, patients filled in questionnaires measuring Self-esteem, Mastery, and Optimism. Finally they completed the SF-36 measuring HRQL. Regression analyses were used to investigate the direct and mediated effect of ability to adapt on health state utilities. Results Persons' ability to adapt did not add considerably to the explanation of health state utilities above HRQL. In the TTO no additional variance was explained by adaptive abilities (Δ R2 = .00, β = .02), in the VAS a minor proportion of the variance was explained by adaptive abilities (Δ R2 = .05, β = .33). The effect of adaptation on health state utilities seems to be mediated by the mental health domain of quality of life. Conclusions Patients with stronger adaptive abilities, based on their optimism, mastery and self-esteem, may more easily enhance their mental health after being diagnosed with a chronic illness, which leads to higher health state utilities.

In this issue of the Journal, Lipkus and others 1 present a study describing the influence of patient numeracy on the understanding of treatment benefits communicated using the prediction model Adjuvant Online (or Adjuvant! for short). Increasingly, oncologists and their patients have access to such models, enabling them to calculate individualized probabilities of outcomes such as survival or chance of recurrence. Adjuvant! is probably the most widely used, but other models are finding their way into the consulting room too, such as Oncotype DX (Genomic Health, Redwood City, CA) for breast and colon cancer and the Kattan nomograms for prostate cancer. The models generally provide pretreatment prognostic information to estimate the benefit that patients may obtain from various available treatment options. Adjuvant! is a Web-based program that calculates individualized, 10-year disease-free survival probabilities and predicts the benefit of adjuvant systemic therapy (see www.adjuvantonline.com). The models have generally been developed to support decision making of oncologists but are increasingly being used in clinical encounters with patients. However, patient communication regarding the probabilities from these models is not straightforward. Little research on the impact of using these models with patients has been made available, but we know from the vast literature on risk communication that patients have difficulty understanding risks. The article by Lipkus and others confirms this. Adjuvant! has been implemented widely, a practice that may be seen as remarkable in view of the complexities inherent to risk communication. It is therefore important that studies that assess patients’ understanding of the output from the model and its impact on decision making, such as that of Lipkus and others, are carried out in clinical practice. Their study is not only of interest because of the findings related to patient numeracy but also, and perhaps even more so, because of the overall picture it paints of patients’ understanding, or lack of understanding, of the model’s output. The results are disconcerting, as the authors rightly conclude, and confirm that 30% to 40% of women were unable to correctly identify the treatment that maximized cancer-free survival. Furthermore, less than half of the patients provided a correct estimate of their 10-year disease-free survival after surgery, and this figure dropped to less than 1 in 5 for estimates provided after the various adjuvant therapies. This study is not the first to show the difficulty that patients have with understanding the Adjuvant! printouts. It seems that the information is simply too complex, even for patients high in numeracy, although they admittedly do fare better. In the discussion section of their article, Lipkus and others suggest replacing the Adjuvant! bar charts, shown in Figure 1, with simpler graphics proposed by Zikmund-Fisher and others, who found that the use of pictographs instead of bars (and the addition of the word more in the legend: ‘‘x more women of 100 are alive because of therapy’’) doubled the proportion of women responding correctly. However, a much larger improvement (resulting in 2 out of 3 women answering correctly) was obtained by using a 2-option graph instead of the 4option one and by omitting the ‘‘no additional therapy’’ and ‘‘chemotherapy only’’ options. This was legitimate, as argued by the authors, ‘‘because the physician in our scenario strongly recommended hormonal therapy.’’ This suggestion therefore implies that to help patients reach a decision, providers have to limit patients’ decisional control by preselecting the treatment options to present. However, because we know that clinicians and patients From Leiden University Medical Center, Leiden, The Netherlands.

Lower limb joint replacement surgery provides a considerable improvement in quality of life (QoL), but is associated with peroperative blood loss and with anemia in the direct postoperative period. General acceptance of low transfusion thresholds and shorter postoperative hospital stays will result in patients leaving hospital with low hemoglobin (Hb) levels. To evaluate the role of QoL scores as a possible alternative for Hb values to serve as a further indicator for red blood cell transfusion, we performed a secondary analysis of a previously conducted randomized clinical trial to compare QoL and fatigue scores with simultaneously measured pre- and postoperative Hb levels, in total hip and knee arthroplasty patients.QoL measurement was measured preoperatively and twice up to 14 days postoperatively using the Functional Status Index (FSI), the Visual Analogue Score (VAS)-Fatigue score, and the Functional Assessment of Cancer Therapy Anemia (FACT-Anemia) subscale. Pearson correlation coefficients between (change in) FSI, VAS-Fatigue, and FACT-Anemia subscale scores and (change in) Hb levels were calculated. Additionally, partial correlations were calculated and linear regression analysis was performed, correcting for possible confounding variables.A total of 603 patients were evaluated. All patients scored worse postoperatively, but none of the scores correlated with Hb values, neither after correcting for confounding factors. Even more, the changes between preoperative and postoperative Hb levels were not correlated with changes in fatigue scores.In hip and knee prosthesis surgery no correlation existed between postoperative Hb levels or acute postoperative decline in Hb values and QoL scores (FSI, VAS-Fatigue, or FACT-Anemia).

Adaptive conjoint analysis (ACA) is an individually tailored preferences elicitation technique that mimics actual decision-making processes by asking participants to make trade-offs between the various dimensions that underlie decision problems. ACA is increasingly applied in patient preferences assessments but formal evaluation of its validity and reliability is lacking.To investigate ACA's validity and reliability in elicitation of treatment outcome preferences.Sixty-eight disease-free rectal cancer patients, treated with surgery with or without preoperative radiotherapy were asked to complete exercises to assess their preferences for radiotherapy [using the treatment trade-off method (TTM)] and for key outcomes associated with radiotherapy (using ACA). We assessed (i) rank ordering of ACA-derived outcome-probability utilities, (ii) compensatory decision making, (iii) ACA test-retest reliability, and (iv) concordance of ACA- and TTM-based preferences.All participants completed the TTM and 66 completed the ACA questionnaire, in 15 min on average. Outcome utilities were rank ordered in agreement with probabilities from best to worst in most participants, except for sexual dysfunction. Most participants were willing to trade survival and their most important outcome. Mean importance ratings were similar at retest. ACA- and TTM-based preferences differed. TTM-based preferences were related to past treatment, ACA-based preferences were not.ACA assesses group-level preferences reliably over time and captures individual preferences independently from treatment experience in treated cancer patients. ACA seems a valid treatment outcome preference elicitation method in a context in which trade-offs between cure and quality of life need to be considered.

To evaluate the validity and reliability of the English translation of an interviewer-administered pelvic floor questionnaire, the "Pelvic Floor Inventories Leiden" (PeLFIs) for women, which addresses complaints of prolapse, bladder, and bowel dysfunction, pelvic floor pain and/or sexual dysfunction related to pelvic floor dysfunction.The formal forward-backward translation of the PeLFIs was performed by bilingual Dutch/English translators. The final English version was administered to healthy volunteers (N = 94) and patients (N = 180) in Canada and the United States. Psychometric properties of the English version were examined, including internal consistency, test-retest reliability, content, and construct validity. Internal consistency was measured using Cronbach's alpha. Test-retest reliability was assessed by intraclass correlation coefficients. Construct validity was established by comparing scores in healthy volunteers and patients (using t-tests) and by intercorrelating domains.The forward-backward translation of the English version of the PeLFIs was consistent with the original Dutch questionnaire. In total, 274 questionnaires were administered. The retest was administered 2 weeks after the initial PeLFIs interview. Internal consistency of the questionnaire was 0.88 for the total scale. Cronbach's alpha of the domains ranged from 0.71 to 0.95. For the test-retest reliability, the agreement rate between the two tests exceeded 95% and the intraclass correlation ranged from 0.6 to 0.8. The differences between healthy volunteers and patients were statistically significant for all domains, but did not exceed the minimal important difference for some domains. Correlations between the domains were moderate to high.The PeLFIs questionnaire has been translated successfully into English and in its evaluation has shown adequate internal consistency and reliability.

Objective: Patient values are not routinely assessed in clinical practice. Adaptive Conjoint Analysis (ACA) is increasingly applied in studies assessing treatment preferences, and could provide a means to routinely assess individual patients' treatment preferences. Methods: An ACA-questionnaire was administered three times (7-10 days apart) to 98 long-term rectal cancer survivors either on a portable computer or through internet, to assess whether (a) responses differ according to administration mode, (b) relative importances of rectal cancer treatment outcomes (survival, local control, incontinence, sexual problems) consolidate over time, (c) ACA-outcomes are sufficiently reliable (ICC) for use in individual decision-making. We also evaluated patients' acceptance of ACA. Results: Mode did not affect ACA-completion or evaluation. Importance scores did not consolidate over time. ICCs were poor for sexual problems and fair for the other outcomes, and were at least equal or higher from first to second retest. Most participants valued completing the ACA-questionnaire and learning their results. Conclusion: Values did not show consolidation over time. ACA-derived preferences should not determine which treatment patients should choose. Practice implications: Findings extend ACA-validation studies to the health care setting and suggest that ACA-questionnaires might be appreciated as adjuncts to treatment decision-making in newly diagnosed patients. (C) 2009 Elsevier Ireland Ltd. All rights reserved.

To compare health-related quality of life, emotional functioning and illness cognitions between people with and without a stoma after rectal cancer treatment about 8 years ago and to examine the relation between illness cognitions and health-related quality of life and emotional functioning.Sixty-two people who had undergone abdominoperineal resection with a permanent stoma and 60 people who had undergone low anterior resection without a permanent stoma participated. Questionnaires included the European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-C30, the Hospital Anxiety and Depression Scale, and the Illness Cognition Questionnaire.There were no significant differences between people with and without a stoma in health-related quality of life, emotional functioning and illness cognitions. There were moderate and significant relations between the illness cognitions helplessness (negative) and disease acceptance (positive) on the one hand and health-related quality of life and emotional functioning on the other. For helplessness this relation barely differed between people with and without a stoma, but for disease acceptance this relation was stronger for people without a stoma than for people with a stoma.The study showed no differences in health-related quality of life, but a stronger relation between disease acceptance and health-related quality of life for people without a stoma than for people with a stoma. If this relation is causal, people with negative illness cognitions after rectal cancer treatment might be identified and offered help.

Contains fulltext : 88291.pdf (Publisher’s version ) (Open Access) BACKGROUND: Clinical practice guidelines are largely conceived as tools that will inform health professionals' decisions rather than foster patient involvement in decision making. The time now seems right to adapt clinical practice guidelines in such a way that both the professional's perspective as care provider and the patients' preferences and characteristics are being weighed equally in the decision-making process. We hypothesise that clinical practice guidelines can be adapted to facilitate the integration of individual patients' preferences in clinical decision making. This research protocol asks two questions: How should clinical practice guidelines be adapted to elicit patient preferences and to support shared decision making? What type of clinical decisions are perceived as most requiring consideration of individual patients' preferences rather than promoting a single best choice? METHODS: Stakeholders' opinions and ideas will be explored through an 18-month qualitative study. Data will be collected from in-depth individual interviews. A purposive sample of 20 to 25 key-informants will be selected among three groups of stakeholders: health professionals using guidelines (e.g., physicians, nurses); experts at the macro- and meso-level, including guideline and decision aids developers, policy makers, and researchers; and patient representatives. Ideas and recommendations expressed by stakeholders will be prioritized by nominal group technique in expert meetings. DISCUSSION: One-for-all guidelines do not account for differences in patients' characteristics and for their preferences for medical interventions and health outcomes, suggesting a need for flexible guidelines that facilitate patient involvement in clinical decision making. The question is how this can be achieved. This study is not about patient participation in guideline development, a closely related and important issue that does not however substitute for, or guarantee individual patient involvement in clinical decisions. The study results will provide the needed background for recommendations about potential effective and feasible strategies to ensure greater responsiveness of clinical practice guidelines to individual patient's preferences in clinical decision-making.

Objectives: To obtain quality-adjusted life-years, different respondent groups, such as patients or the general public, may be asked to value health states. Until now, it remains unclear if the respondent group has an influence on the values obtained. We assessed this issue through meta-analysis. Methods: A literature search was performed for studies reporting valuations given by patients and nonpatients. Studies using indirect utility instruments were excluded. Results: From 30 eligible studies, 40 estimators were retrieved revealing a difference between respondent group (Cohen's d = 0.20, P < 0.01). When elicitation methods were analyzed separately, patients gave higher valuations than nonpatients using the time trade-off (TTO) (N = 25, unstandardized d = 0.05, P < 0.05) and the visual analog scale (VAS) (N = 22, unstandardized d = 0.04, P < 0.05). When the standard gamble was used, no difference was seen (N = 24, unstandardized d = 0.01, P = 0.70). Conclusion: In contrast with Dolders et al., our results show that patients give higher valuations than members of the general public. For future cost-utility analyses, researchers should be aware of the differential effects of respondent group for the elicitation methods TTO and VAS.

Purpose: Effective communication of DNA-test results requires a sound terminology. However, the variety of terms in literature for DNA-test results other than pathogenic, may create inconsistencies between professionals, and misunderstanding in patients. Therefore, we conducted a theoretical and empirical analysis of the terms most frequently used in articles between 2002 and 2007 for BRCA 1/2-test results other than pathogenic.(1) Design: We analyzed the content validity of the no-pathogenic DNA-test result-terms by comparing the literal and intended meaning of the terms and by examining their clarity and the inclusion of all relevant information. We analyzed the reliability of the terms by measuring the strength of association between terms and their meanings and the consistency among different authors over time. Results: Two hundred twenty-seven articles with 361 no-pathogenic DNA-test result-terms were found. Only two terms seemed to have acceptable validity: variant of uncertain clinical significance and no-pathogenic-DNA-test-result. Only variant of uncertain clinical significance and true negative were found to be used reliably in the literature. Conclusions: Current DNA nomenclature lacks validity and reliability. Transparent DNA-test result terminology should be developed covering both laboratory findings and clinical meaning. Genet Med 2009:11(10): 742-749.

Background . A major challenge in surgery is the integration of evidence-based medicine and patient autonomy. The authors present a randomized trial studying the effect of an individualized evidence-based brochure (IB) on patients' autonomous behavior, patients' ideals of autonomy, and quality of life. Method . Patients with an asymptomatic abdominal aneurysm and their surgeon were randomized to receive a general brochure (GB) or an IB presenting survival information and a ranking of the treatment strategies. Before and after receiving the brochure, patients filled out questionnaires on their behavior during the consultation, ideals of patient autonomy, and quality of life. Surgeons answered a short checklist evaluating the consultation. Results . One hundred patients participated, 49 in the intervention, 51 in the control group. The IB group had a better understanding of important issues in the treatment decision, had prepared more questions, and was less satisfied with the duration of the consultation. Their impression that the surgeon perceived them more as a medical problem than a patient with a problem increased. They agreed less with the surgeon's advice and lost some of their belief in ``the doctor knows best.'' Beforehand, the IB group had a stronger preference for patient-based decisions, but afterward they displayed more surgeon-based decisions. No effects were seen on patients' quality of life. Conclusions . Individualized evidence-based information stimulated patients' active involvement but in the context of our study led to less patient-based decisions. Patient-made decisions and patient autonomy should, however, not be equated.

Research has shown that patients' preferences for adjuvant chemotherapy do not change as a result of experience. However, the preferences of experienced patients are usually more favourable than those of inexperienced patients. These results indicate a shift in preferences after the decision to proceed with adjuvant chemotherapy has been made, but before actual experience. We tested this assumption in early-stage breast and colorectal cancer patients. We asked patients to provide their preferences for chemotherapy before surgery and thus before they knew whether chemotherapy would be advised (T(1)), after surgery but before the start of chemotherapy (T(2)) and about 1 month after chemotherapy (T(3)). Patients who did not undergo chemotherapy co-operated at similar points in time. Preferences were measured on a nine-point scale, ranging from (1) 'very strong preference for no chemotherapy' to (9) 'very strong preference for chemotherapy'. As hypothesized, the preferences of patients who would be treated with chemotherapy became more favourable after the treatment decision had been made (n = 7, P = 0.06). The preferences of patients for whom chemotherapy was not part of the treatment plan showed the opposite effect (n = 38, P = 0.03). We did not find any effect of experiencing treatment (n = 22, P = 0.62) or the passing of time (n = 81, P = 0.25) on the stability of preferences. We conclude that the frequently observed discrepancy in treatment preferences between experienced and inexperienced patients seems to be an effect of the treatment decision and not of experience of the treatment.

A population-based case-control study was conducted between July 1984 and February 1988 in the Spanish island of Majorca; 286 incident colorectal cancer cases, 295 population controls and 203 hospital controls were interviewed using a food frequency questionnaire. In a multivariate analysis, an increased risk of colon cancer was found for high consumption of fresh meats (RR = 2.87) while a high consumption of cruciferous vegetables afforded protection (RR = 0.48). For rectal cancer an increased risk was associated with dairy products (RR = 3.08) while a protection was afforded by consumption of cruciferae (RR = 0.50). For colorectal cancer, the cereal food group also showed an increase in risk (RR = 1.92). When cases were compared to hospital controls, the effects of cruciferae in colon and rectum and those of dairy products in rectal cancer remained. The magnitude of the RR estimates was decreased for most comparisons, although in general terms the direction of the associations was the same. In addition, univariate analyses of food groups also suggested significant increases in risk of colorectal cancer for increasing consumption of cereals, potatoes, pastry, eggs and number of meals per day. An indication was found of a reduction in risk for consumers of coffee. An analysis based on risk scores was also conducted and a 4-fold increase in the risk of colorectal cancer and a highly significant statistical trend was found for high consumption of fresh meat, dairy products and cereals combined with low consumption of cruciferae.

Objective: There is a wide range of autonomic symptoms (AS) in Parkinson disease (PD), but the full spectrum has never been evaluated with a validated instrument and in comparison with control subjects. In this study a reliable and valid instrument, the SCOPA–AUT, was used to evaluate the occurrence of AS in a large cohort of patients with PD and control subjects and to assess the relations with demographic, disease-related, and clinical variables. Methods: A cohort of 420 patients with PD was evaluated for the occurrence of AS, motor and nonmotor symptoms, as well as for demographic and disease-related characteristics. Results were compared with those of 150 control subjects. Associations between AS and demographic and clinical characteristics were also studied. Results: For all autonomic domains, patients with PD reported more symptoms compared to control subjects, with the greatest differences in the gastrointestinal and urinary domain. Higher age, greater disease severity, and higher doses of dopaminergic medication were related to more autonomic problems. Autonomic symptom severity was associated with more motor dysfunction, depressive symptoms, cognitive dysfunction, psychiatric complications, nighttime sleep disturbances, and excessive daytime sleepiness (all p values Conclusions: Autonomic symptoms (AS) are an important feature of Parkinson disease (PD) and increase with age, disease severity, and medication use. The prominent presence of AS warrants increased clinical awareness and highlights the need for efficacious therapies for the wide spectrum of problems related to this domain of PD.

Aim To elicit surgery preferences of patients who have experience with either low anterior resection (LAR) or abdominoperineal resection (APR) and its outcomes, to support decision-making in future patients with resectable rectal cancer. Methods One hundred and twenty-two patients were interviewed. Surgery preference was assessed in two ways. In the treatment trade-off method, the certainty of a stoma was hypothetically weighed against the risk of incontinence. In the time trade-off method, remaining life expectancy was traded off to avoid a permanent stoma or faecal incontinence. Results To avoid APR, LAR patients accepted a much higher risk of incontinence than APR patients. In fact, 71% of the LAR patients chose LAR if they would certainly suffer monthly incontinence, and still 32% if they would certainly suffer daily incontinence. Nevertheless, APR patients would give up less remaining life years to be without a permanent stoma than LAR patients to be without monthly incontinence. Conclusions Most patients preferred LAR above APR, even if LAR involved a risk of faecal incontinence. This seems to justify that LAR, if surgically possible, is performed in the first instance. However, since APR patients could live well with a permanent stoma, we recommend clearly informing patients before surgery about the surgical options and their potential outcomes.

We evaluated the validity, reliability, and potential responsiveness of the Beck Depression Inventory (BDI) in patients with Parkinson's disease (PD). In part 1 of the study, 92 patients with PD underwent a structured clinical interview for DSM major depression and based on this patients were considered depressed (PD-D) or nondepressed (PD-ND). Subsequently, patients filled in the BDI. In part 2, a postal survey consisting the BDI was performed in 185 PD patients and 112 controls. Test-retest reliability was assessed in 60 PD patients. The factor analysis revealed a cognitive-affective and a somatic factor. Cronbachs alpha for the BDI was 0.88. Mean BDI indicated significant differences (P

Patients' perceptions of having had freedom of choice in treatment decision-making are shown to have implications for their quality of life. It is, therefore, important to determine what factors underlie these perceptions. One factor that has been studied is whether or not patients believed that their doctor had offered choice of treatment. However, even when choice is actually offered, patients may still feel that they have no choice. Little attention has been paid to other factors that may contribute to patients' perceptions of having had no choice. Our purpose was to explore (1) whether early-stage breast cancer patients perceived to have had a choice with regard to adjuvant chemotherapy, and (2) their reasons for having perceived no choice.The determinants of no choice that we examined were: (1) (preferred) involvement in treatment decision-making, (2) perceived clinical benefits of chemotherapy (e.g., cure), (3) perceived psychological benefits (e.g., less worries), and (4) perception of being able to cope with the side effects. All predictors, as well as patient and clinical characteristics, were entered simultaneously in a multiple logistic regression analysis and non-significant predictors were removed step-by-step, until only significant predictors (p0.05) remained. Because determinants may differ between patients with experience of chemotherapy and those without, both treatment groups were analyzed separately.Four hundred and forty-six patients filled out the questionnaire (62%). Sixty-six percent of patients who had been treated with chemotherapy and 86% of inexperienced patients had perceived no treatment choice. In both treatment groups, patients who preferred a shared role or a passive role in treatment decision-making were statistically significantly more likely to have perceived no treatment choice than patients who preferred an active role. Surprisingly, beliefs about the clinical and psychological benefits of chemotherapy did not influence patients' perceptions of having had choice of treatment.If we adhere to patient autonomy and shared decision making, we may consider the perception of no treatment choice as a negative outcome of treatment decision-making. However, if this is the result of the patients' preference for less active involvement in treatment decision-making, the topic of perception of no treatment choice may be viewed in a different light.

Objective: To survey members of the American Society for Bioethics and Humanities (ASBH; n=327) and of the Society for Medical Decision Making (SMDM; n=77) to elicit the similarities and differences in their reasoning about two clinical cases that involved ethical dilemmas. Cases: Case 1 was that of a patient refusing treatment that a surgeon thought would be beneficial. Case 2 dealt with end-of-life care. The argument was whether intensive treatment should be continued of an unconscious patient with multiorgan failure. Method: Four questions, with structured multiple alternatives, were asked about each case: identified core problems, needed additional information, appropriate next steps and who the decision maker should be. Observations and results: Substantial similarities were noticed between the two groups in identifying the core problems, the information needed and the appropriate next steps. SMDM members gave more weight to outcomes and trade-offs and ASBH members had patient autonomy trump other considerations more strongly. In case 1, more than 60% of ASBH respondents identified the patient alone as the decision maker, whereas members of SMDM were almost evenly divided between having the patient as the solo decision maker or preferring a group of some sort as the decision maker, a significant difference (p

Objective Missing forms may pose problems in health related quality of life (QOL) studies, because the absence of a QOL measure may be related to the patient’s health and hence to the patient’s QOL itself. Studying patterns of missingness, dropout, and the possible impact of missing data on QOL measures is an important step in reporting outcomes of QOL studies. We study patterns of dropout and evaluate the impact of missing forms in the TME QOL substudy. Methods: Patients with rectal cancer, randomized to receive either radiotherapy plus total mesorectal excision (TME) or TME only were included in the TME trial. QOL was evaluated in 1302 Dutch patients, before treatment, and 3, 6, 12, 18 and 24 months after surgery. Here only the visual analogue score (VAS) was studied. Results: At baseline, differences between VAS scores were found with respect to whether the QOL forms were dated before or after radiotherapy and surgery. Differences were small between different statistical methods accounting for dropout; only a cross-sectional analysis gave biased results. Conclusion The results of the sensitivity analysis indicated that a linear mixed model analysis is a reliable and attractive approach for this study.

We developed a questionnaire to assess autonomic symptoms in patients with Parkinson's disease (PD) and evaluated its reliability and validity. Based on the results of a postal survey in 46 PD patients, 21 multiple system atrophy patients, and 8 movement disorders specialists, items were included according to their frequency, burden, and clinical relevance. The questionnaire was evaluated in 140 PD patients and 100 controls, and test-retest reliability was established in a sample of 55 PD patients. The SCOPA-AUT consists of 25 items assessing the following regions: gastrointestinal (7), urinary (6), cardiovascular (3), thermoregulatory (4), pupillomotor (1), and sexual (2 items for men and 2 items for women) dysfunction. Test-retest reliability was good. Autonomic problems increased significantly with increasing disease severity for all autonomic regions, except sexual dysfunction. We conclude that SCOPA-AUT is a reliable and valid questionnaire that evaluates autonomic dysfunction in PD.

Background Hormone therapy (HT) provides the most effective relief of menopausal symptoms. This therapy is associated with a decreased risk of osteoporosis and colorectal cancer but increased risks of cardiovascular disease (CVD), venous thrombosis, and breast cancer. Our objective was to identify which women should benefit from short-term HT by exploring the trade-off between symptom relief and risks of inducing disease. Methods A Markov model simulates the effect of short-term (2 years) estrogen and progestin HT on life expectancy and quality-adjusted life expectancy (QALE) among 50-year-old menopausal women with intact uteri, using findings from the Women's Health Initiative. Quality-of-life (QOL) utility scores were derived from the literature. We assumed HT-affected QOL only during perimenopause, when it reduced symptoms by 80%. Results Among asymptomatic women, short-term HT was associated with net losses in life expectancy and QALE of 1 to 3 months, depending on CVD risk. Women with mild or severe menopausal symptoms gained 3 to 4 months or 7 to 8 months of QALE, respectively. Among women at low risk for CVD, HT extended QALE if menopausal symptoms lowered QOL by as little as 4%. Among women at elevated CVD risk, HT extended QALE only if symptoms lowered QOL by at least 12%. Conclusions Hormone therapy is associated with losses in survival but gains in QALE for women with menopausal symptoms. Women expected to benefit from short-term HT can be identified by the severity of their menopausal symptoms and CVD risk.

The aim of this study was to assess the accuracy of an interview-based assessment of comorbidity, in patients with Parkinson's disease (PD). The Cumulative Illness Rating Scale-Geriatric (CIRS-G) was completed (1) in an interview with 31 PD patients and their caregivers, and (2) by reviewing the patient's medical charts from their general practitioners. Based on the interview, all patients had some comorbidity, 84% had one or more moderate comorbid diseases. The most frequently affected organ systems were "lower gastrointestinal" and "genitourinary". The mean +/- SD total score of the interview-based (chart-based) CIRS-G was 6.9 +/- 3.8 (7.6 +/- 3.5) with a mean of 4.3 +/- 1.9 (5.0 +/- 1.9) affected organ systems and a mean of 2.1 +/- 1.7 (2.3 +/- 1.6) organ systems with at least moderate comorbidity per patient. The agreement (intraclass correlation coefficients) between the interview-based and chart-based assessments for the six summary scores ranged from 0.69 to 0.81. The agreement for the 14 organ systems ranged from 0.13 to 1.00 (weighted kappa); 12 had a K(w) above 0.40 (moderate agreement). The comorbidity summary scores had a moderate correlation with age and disability. The interview-based assessment of the CIRS-G is easy to apply and is an accurate method to assess comorbidity in patients with PD.

Objectives To assess preference of reconstructive treatment of upper extremities in subjects with tetraplegia compared with preference of treatment of 3 other impairments and to determine the effect of subjects’ characteristics on preference of upper-extremity reconstruction. Design Survey. Setting Two specialized spinal cord injury centers in the Netherlands. Participants A consecutive sample of 47 patients with tetraplegia in stable condition. Interventions Not applicable. Main Outcome Measure The quality weight of 5 tetraplegic health states determined with the time trade-off technique and expressed as a single value (the “utility”) on a scale between 0 (worst possible situation) and 1 (best possible situation). Results The response rate was 92%. The utility of tetraplegia ± standard deviation was .57±.30. The utilities of tetraplegia without impairment in one of the following functions were .69±.33 for sexuality, .69±.33 for standing/walking, .63±.31 for bladder and bowel function, and .65±.32 for upper-extremity function. The differences between these utilities and the utility of tetraplegia were significant (P

Ethicists differ considerably in their reasons for using empirical data. This paper presents a brief overview of four traditional approaches to the use of empirical data: "the prescriptive applied ethicists," "the theorists," "the critical applied ethicists," and "the particularists." The main aim of this paper is to introduce a fifth approach of more recent date (i.e. "integrated empirical ethics") and to offer some methodological directives for research in integrated empirical ethics. All five approaches are presented in a table for heuristic purposes. The table consists of eight columns: "view on distinction descriptive-prescriptive sciences," "location of moral authority," "central goal(s)," "types of normativity," "use of empirical data," "method," "interaction empirical data and moral theory," and "cooperation with descriptive sciences." Ethicists can use the table in order to identify their own approach. Reflection on these issues prior to starting research in empirical ethics should lead to harmonization of the different scientific disciplines and effective planning of the final research design. Integrated empirical ethics (IEE) refers to studies in which ethicists and descriptive scientists cooperate together continuously and intensively. Both disciplines try to integrate moral theory and empirical data in order to reach a normative conclusion with respect to a specific social practice. IEE is not wholly prescriptive or wholly descriptive since IEE assumes an interdepence between facts and values and between the empirical and the normative. The paper ends with three suggestions for consideration on some of the future challenges of integrated empirical ethics.

The purpose of the study was to analyse the needs of women who participated in a routine follow-up programme after treatment for primary breast cancer. A cross-sectional survey was conducted using a postal questionnaire among women without any sign of relapse during the routine follow-up period. The questionnaire was sent 2-4 years after primary surgical treatment. Most important to patients was information on long-term effects of treatment and prognosis, discussion of prevention of breast cancer and hereditary factors and changes in the untreated breast. Patients preferred additional investigations (such as X-ray and blood tests) to be part of routine follow-up visits. Less satisfaction with interpersonal aspects and higher scores on the Hospital Anxiety and Depression Scale (HADS) scale were related to stronger preferences for additional investigation. Receiving adjuvant hormonal or radiotherapy was related to a preference for a more intensive follow-up schedule. There were no significant differences between patients treated with mastectomy compared to treated with breast-conserving therapy. During routine follow-up after a diagnosis of breast cancer, not all patients needed all types of information. When introducing alternative follow-up schedules, individual patients' information needs and preferences should be identified early and incorporated into the follow-up routine care, to target resources and maximise the likelihood that positive patient outcomes will result.

In dit hoofdstuk wordt het onderzoek naar de validiteit en de betrouwbaarheid van de Nederlandse vertaling van de Parkinson Disease Quality of Life Questionnaire 39 (pdq-39) beschreven. De pdq-39 is een ziektespecifiek meetinstrument dat in wetenschappelijk onderzoek wordt gebruikt om de kwaliteit van leven bij patienten met de ziekte van Parkinson te meten. De pdq-39 bestaat uit 39 items, verdeeld over acht schalen. Uit het onderzoek blijkt dat de inhoudsvaliditeit, begripsvaliditeit en discriminante validiteit goed zijn. De interne consistentie van alle schalen is eveneens goed, hoewel ‘lichamelijk ongemak’ onder de norm blijft die gewoonlijk wordt gesteld aan gebruik in wetenschappelijk onderzoek. De factorstructuur laat heel kleine verschillen zien met de oorspronkelijke versie, hetgeen naar verwachting niet tot problemen zal leiden in internationaal onderzoek. De test-hertestbetrouwbaarheid en responsiviteit zijn in dit onderzoek niet onderzocht. De pdq-39 is vooral bedoeld als een instrument voor wetenschappelijk onderzoek en is, met uitzondering van de schaal ‘mobiliteit’, minder geschikt als uitkomstmaat voor de behandeling van individuele patienten.