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This paper introduces anchor levels as a new tool for multiattribute utility theory. Anchor levels are attribute levels whose values are not affected by other attributes. They allow for new interpretations and generalizations of known representations and utility measurement techniques. Generalizations of earlier techniques can be obtained because cases with complex interactions between attributes can now be handled. Anchor levels serve not only to enhance the generality, but also the tractability, of utility measurements, because stimuli can better be targeted toward the perception and real situation of clients. In an application, anchor levels were applied to the measurement of quality of life during radiotherapy treatment, where there are complex interactions with what happens before and after. Using anchor levels, the measurements could be related exactly to the situation of the clients, thus simplifying the clients' cognitive burden.

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.

The standard gamble (SG) method and the time tradeoff (TTO) method are commonly used tomeasure utilities. However, they are distorted by biases due to loss aversion, scale compatibility, utility curvature for life duration, and probability weighting. This article applies corrections for these biases and provides new data on these biases and their corrections. The SG and TTO utilities of 6 rheumatoid arthritis health states were assessed for 45 healthy respondents. Various corrections of utilities were considered. The uncorrected TTO scores and the corrected (for utility curvature) TTO scores provided similar results. This article provides arguments suggesting that the TTO scores are biased upward rather than having balanced biases. The only downward bias in TTO scores was small and probably cannot offset the upward biases. TheTTOscores are higher than the theoretically most preferred correction of the SG, the mixed correction. These findings suggest that uncorrected SG scores, which are higher than TTO scores, are too high.

The purpose of this study was to develop a short questionnaire for psychosocial functioning in patients with Parkinson's Disease (PD). The SCales for Outcomes in Parkinson's disease-PsychoSocial questionnaire (SCOPA-PS) was tested in a survey and compared with other instruments and with medical information. This survey was sent to 205 patents with idiopathic PD. Eighty-six percent of the questionnaires were returned. Cronbach's alpha was 0.83. Two-week test-retest reliability was 0.85 (intraclass correlation coefficient). Construct validity with other scales (Spearman's rho) was 0.82 for the Parkinson's Disease Questionnaire-39-item version (PDQ-39), 0.76 for the PDQ-8, 0.69 for the Hospital Anxiety and Depression Scale, -0.61 for the Euroqol, and -0.60 for a visual analogue scale evaluating Quality-of-Life. The summary index revealed a significant increase with increasing disease severity. The SCOPA-PS is a new, short psychosocial questionnaire for patients with PD with good clinimetric properties.

We assessed the clinometric characteristics of rating scales used for the evaluation of motor impairment and disability of patients with Parkinson's disease (PD), conducting a systematic review of PD rating scales published from 1960 to the present. Thirty studies describing clinometrics of 11 rating scales used for PD were identified. Outcome measures included validity (including factor structure), reliability (internal consistency, inter-rater, and intrarater) and responsiveness. We traced three impairment scales (Webster, Columbia University Rating Scale [CURS] and Parkinson's Disease Impairment Scale), four disability scales (Schwab and England, Northwestern University Disability Scale [NUDS], Intermediate Scale for Assessment of PD, and Extensive Disability Scale), and four scales evaluating both impairment and disability (New York University, University of California Los Angeles, Unified Parkinson's Disease Rating Scale [UPDRS], and Short Parkinson Evaluation Scale). The scales showed large differences in the extent of representation of items related to signs considered responsive to dopaminergic treatment or to those signs that appear late in the disease course and lack responsiveness to treatment. Regardless of the scale, there was a conspicuous lack of consistency concerning inter-rater reliability of bradykinesia, tremor, and rigidity. Overall disability items displayed moderate to good inter-rater reliability. The available evidence shows that CURS, NUDS, and UPDRS have moderate to good reliability and validity. In contrast to their widespread clinical use for assessment of impairment and disability in PD, the majority of the rating scales have either not been subjected to an extensive clinometric evaluation or have demonstrated clinometric shortcomings. The CURS, NUDS, and UPDRS are the most evaluated, valid, and reliable scales currently available.

Patients with intractable rheumatoid arthritis (RA) may benefit from treatment with high dose chemotherapy followed by rescue with autologous hematopoietic peripheral blood stem cell transplant (HSCT). We investigated whether the risks of this approach are acceptable to patients with RA and rheumatologists and whether risk taking by patients was associated with disease characteristics, socioeconomic variables, and/or personality traits.A survey in the outpatient clinic was conducted among 2 cohorts of 45 (cohort A) and 51 (cohort B) RA patients with active disease. Patients received information about the potential benefit of HSCT (2/3 chance of a good clinical response, 1/3 no response) and treatment related morbidity and mortality. Cure was assumed not to be a realistic perspective. Cohort A was asked to choose between their own disease state for an indefinite time or HSCT. Nonparametric tests were performed to evaluate putative predictive factors that led patients to accept transplant related mortality (TRM): swollen joint count, tender joint count, visual analog scale (VAS) measures of disease activity and pain, erythrocyte sedimentation rate, Health Assessment Questionnaire (HAQ), socioeconomic variables, RA Quality of Life Questionnaire (RAQoL), and the Life Orientation Test. Cohort B was asked to consider a worst case scenario with respect to their disease activity. The minimal duration of benefit was assessed, given a TRM of 0.01% and 2%. To evaluate treatment preference of physicians, 96 Dutch rheumatologists responded to a hypothetical clinical case analogous to the interviews with RA patients. The minimum duration of benefit was assessed, given a TRM of 2% and the maximal TRM acceptable to rheumatologists if duration of benefit was 2 years in 2/3 patients.In cohort A, 5 of 45 patients were willing to accept risk of death. VAS disease activity (p = 0.006), VAS pain (p = 0.021), and HAQ (p = 0.05) were significantly higher in patients willing to accept risk of death. Religiosity (p = 0.093), a higher Ritchie Articular Index (p = 0.096), and low quality of life (by RAQoL) (p = 0.133) showed trends toward risk taking. In cohort B, 22 of 50 patients (44%) were willing to accept a risk of TRM related to HSCT. For the 22 patients the median required duration of benefit given a TRM of 2% was 5 years (range 1-15). Physicians also required a median duration of benefit of 5 years.We evaluated risk taking in patients with RA and physicians based on a realistic perspective in which the tradeoff between short term risks and possible longterm benefit of HSCT was investigated. Based on current efficacy data for HSCT (2 years improvement in 2/3 patients), half the patients would accept the current TRM of 2%, based on registry results. Patients willing to accept TRM had higher VAS disease activity, VAS pain, and HAQ. Doctors were more willing to accept mortality in the treatment of RA.

A concise overview is provided of the methodology of cost-effectiveness analyses, followed by a survey of published CEAs of colorectal cancer treatments. To gain credibility, the methodology applied in CEAs must be further improved. Costs are rarely estimated from the societal perspective, and little is known about how colorectal patients value their treatment and health.

Background We aimed to evaluate the effect of a decision aid (DA) with information only compared to a DA with values clarification exercise (VCE), and to study the role of personality and information seeking style in DA-use, decisional conflict (DC) and knowledge. Methods Two scenario-based experiments were conducted with two different groups of healthy female participants. Dependent measures were: DC, knowledge, and DA-use (time spent, pages viewed, VCE used). Respondents were randomized between a DA with information only (VCE-) and a DA with information plus a VCE(VCE+) (experiment 1), or between information only (VCE-), information plus VCE without referral to VCE(VCE+), and information plus a VCE with specific referral to the VCE, requesting participants to use the VCE(VCE++) (experiment 2). In experiment 2 we additionally measured personality (neuroticism/conscientiousness) and information seeking style (monitoring/blunting). Results Experiment 1. There were no differences in DC, knowledge or DA-use between VCE- (n=70) and VCE+ (n=70). Both DAs lead to a mean gain in knowledge from 39% at baseline to 73% after viewing the DA. Within VCE+, VCE-users (n=32, 46%) reported less DC compared to non-users. Since there was no difference in DC between VCE- and VCE+, this is likely an effect of VCE-use in a self-selected group, and not of the VCE per se. Experiment 2. There were no differences in DC or knowledge between VCE- (n=65), VCE+ (n=66), VCE++ (n=66). In all groups, knowledge increased on average from 42% at baseline to 72% after viewing the DA. Blunters viewed fewer DA-pages (R=0.38, p

Background Patients with intractable rheumatoid arthritis (RA) may benefit from treatment with high dose chemotherapy (HDC) followed by rescue with autologous peripheral blood stem cells (SCT). The aim of this study was to establish whether the risks of this approach are acceptable to patients with RA and whether risk taking was associated with disease associated, socio-economic parameters and/or personality. Objectives Methods 45 RA patients with active RA enrolled. Patients received information about the potential benefit of HDC (2/3 of patients good clinical response, 1/3 not), observed toxicities (alopecia, infections and bleedings) and duration of hospitalisation. Cure was assumed not te be a realistic perspective. Patients were asked what the minimal duration of benefit should be, given a transplant related mortality (TRM) of 0.01% and 2%. Furthermore maximal accepted TRM was asked given a duration of benefit of 2 years. Analysis of predictive factors of patients? willingness to accept risk of death by the Mann-Whitney U-test was performed with parameters of disease activity (Swollen Joint Count, Tender Joint Count, VAS, ESR and HAQ), socio-economic parameters, RAQoL and the Life Orientation Test. Results Of the 45 patients, 5 patients were willing to accept TRM in the treatment of RA, 40 patients were not. Of these 5 patients the mean duration of benefit given a TRM of 0.01% was 45 months (range 2‑96). For a TRM of 2% the mean duration was 52 months (range 6‑120). VAS disease activity (P = 0.006), VAS pain (P = 0.021) and HAQ (P = 0.05) were signicantly higher in these patients. Religiosity (P = 0.093) and a higher Ritchie articular index (P = 0.1) showed a trend towards risk taking. Conclusion We considered an approach to investigate risk taking in patients with RA based on a realistic perspective in which the trade off between short term risks and possible long term gain of HDC was investigated. It was found that patient with a chronic disease such as RA in which prevention of morbidity instead of mortality is the major

PURPOSE: In the era of evidence-based medicine and shared decision making, the formal assessment of patient preference for treatments or treatment outcomes has attracted much attention. In this article, the two most common approaches to the evaluation of preference, ie, utility assessment and probability trade-off assessment, are described. The purpose is to provide clinicians with the background knowledge needed to interpret preference studies published in the literature and to judge whether the reported findings are relevant to their own patients. METHODS: An overview is given of the methods used to assess utilities and probability trade-off scores. Evidence on determinants of such scores is presented. Examples from oncology are provided. Because experience with the treatment plays an important role as a determinant of preferences for both treatments and treatment outcomes, special attention is paid to the interpretation of studies in the light of subject selection. Directions for future research are suggested. CONCLUSION: The choice of approach and the measuring instrument depend on the goal of the preference assessment. Normal psychologic processes, such as coping, adaptation, and cognitive dissonance reduction, cause patients who are about to undergo a therapy or have experienced a therapy to rate it more favorably than other patients do. This should be remembered when using evidence from the literature to inform patients or for patient decision making.

Objective. To study the effects of information, gender, quality of life, and hospitalization on cardiopulmonary resuscitation (CPR) preferences and on the wish for information and participation in CPR discussions. Methods. Seventy-five community-dwelling inhabitants of the city of Leiden and 45 consecutive patients in two hospitals in Leiden, The Netherlands, aged 75 years or older, were interviewed about their CPR preferences in their current states of health and in three hypothetical scenarios. Health-related quality of life (QOL) was assessed in separate items. The subjects were asked about their wishes for information and participation in CPR discussions. Results. The chances of surviving CPR were overestimated. After receiving accurate information, 65% of the subjects, more women than men, did not want CPR. Overall QOL did not differ between men and women. Concerning the separate QOL items, men's CPR preferences were more associated with pain, whereas women's were more associated with being impaired in physical functioning and daily and social activities. CPR preferences in the current state of health did not differ significantly between community-dwelling and hospitalized participants. Although only 6% of all participants had ever discussed CPR with their doctors, 70% indicated they wanted routine CPR discussions (either when in good health at home or upon hospital admission), and 61 % preferred to make the final decision about CPR themselves. Conclusions. CPR preferences are affected by different QOL items in men and women. CPR preferences in the current state of health do not differ between hospitalized and community-dwelling elderly people. As the majority of elderly people want CPR discussions, they should be involved in decision making concerning CPR. Key words: cardiopulmonary resuscitation preferences; quality of life; elderly; hospitalization. (Med Decis Making 2000;20:423-429)

OBJECTIVE—To assess the feasibility, reliability, and validity of the time trade off (TTO) in patients with rheumatoid arthritis (RA). METHODS—The TTO was applied in 194 patients with RA with increasing difficulty in performing activities of daily living. The test-retest reliability was determined in 35 of these patients and was calculated by the intraclass correlation coefficient (ICC). Construct validity was evaluated with the following sets of variables: measures of utility (rating scale), quality of life (RAND 36 item Health Status Survey (RAND-36) and RAQoL), functional status (Health Assessment Questionnaire, grip strength, and walk test), and disease activity (doctor's global assessment, disease activity score, pain, and morning stiffness). RESULTS—Ten patients (5%) did not complete the TTO. The median value of the TTO was 0.77 (range 0.03-1.0). The test-retest ICC of the TTO was 0.85 (p

Background A worldwide variation in policy is seen regarding adjuvant systemic treatment for node negative breast cancer (NNBC). After the first presentations of the 10-year EBCTCG results, a study was carried out in the Netherlands to assess patterns of care and to obtain the views of oncologists as to what constitutes a worthwhile benefit from treatment. Methods A questionnaire regarding patterns of use of and preferences for adjuvant chemotherapy in younger women was mailed to surgical, medical and radiation oncologists in the Netherlands. Results Thirty-five percent stated that NNBC patients under 50 in their hospital never received adjuvant chemotherapy. The majority considered a 10-year survival gain of 6%–10% sufficient to warrant the use of chemotherapy in patients under 50. Surgical oncologists required a larger benefit from treatment than radiotherapists and medical oncologists. The more frequently oncologists treated patients in a research context, the less benefit they required from treatment to make it worthwhile. Conclusions Data such as these are valuable input into the process of guideline development, and may help discussion within the profession as to what benefit offsets the burden of treatment.

Background: The objectives of this study were to evaluate body image, cosmetic results, and quality of life in patients with Crohn's disease of the terminal ileum who had either laparoscopic-assisted or open ileocolic resection, and to determine how patients experienced the pre- and postoperative periods after both procedures. Methods: Thirty-four patients participated: 11 patients after open resection (OR), 11 patients after laparoscopic-assisted resection (LR), and 12 patients without resection (WR). Retrospectively, the patients filled out several questionnaires pertaining to body image, hospital experiences, and quality of life. One-way analysis of variance, Student's t-tests, and Pearson's correlation were used for statistical analysis. Results: The cosmetic score was significantly higher in the LR than in the OR group (p < 0.01). Body image correlated strongly with cosmesis and with quality of life. The hospital experiences of the laparoscopic and open groups were similar. Conclusions: Laparoscopic surgery was associated with better cosmesis than open surgery. Patients do not experience laparoscopic surgery any differently from open surgery.

Objective. Temporary health states cannot be measured in the traditional way by means of techniques such as the time tradeoff (TTO) and the standard gamble (SG), where health states are chronic and are followed by death. Chained methods have been developed to solve this problem. This study assesses the feasibility of a chained TTO and a chained SG, and the consistency and concordance between the two meth ods. Patients and methods. Seventy female early-stage breast cancer patients were interviewed. In using both chained methods, the temporary health state to be evaluated was weighed indirectly with the aid of a temporary anchor health state. The patients were asked to evaluate their actual health states, a hypothetical radiotherapy scenario, and a hypothetical chemotherapy scenario. Results. Sixty-eight patients completed the interview. The use of the anchor health state yielded some problems. A significant difference between the means of the TTO and the SG was found for the anchor health state only. For the other health states, the results were remarkably close, because the design avoided some of the bias effects in traditional measurements. Conclusion. The feasibility and the consistency of the chained procedure were satisfactory for both methods. The problems regarding the anchor health state can be solved by adapting the methods and by the use of a carefully chosen anchor health state. The chained method avoids biases present in the conventional method, and thereby the TTO and the SG may be reconciled. Moreover, there are several psychological advantages to the method, which makes it useful for diseases with uncertain prognoses. Key words: utility assessment; time tradeoff; standard gamble; breast cancer; chemotherapy; ra diotherapy. (Med Decis Making 1998;18:391-399)

In stage I non-seminomatous testicular cancer, the decision between surveillance and adjuvant chemotherapy rests heavily upon the valuation of quality of life. Decision analysis was used to assess at what relapse rate adjuvant chemotherapy is preferred when patients' and clinicians' evaluations are considered. Probabilities were obtained from the literature and from experts. Evaluations of the disease states were obtained from patients (n = 68) and clinicians (n = 50). Results from the model were compared with a treatment preference question, asking for the relapse rate directly. Adjuvant chemotherapy was preferred at relapse rates above 50% when patient evaluations were used. The evaluations of the disease states had a strong impact on the decision. Using clinician evaluations, adjuvant chemotherapy was preferred at relapse rates above 73%. The relapse rates from the treatment preference question were lower: 46% for patients and 35% for clinicians. The results indicate that when patient preferences are accounted for, adjuvant chemotherapy should be considered more often.

Methods often used for the valuation of health states are the time trade-off (TTO) and the visual analog scale (VAS). The VAS is easier than the TTO and can be self-administered; however it usually leads to lower scores. In the literature a power transformation of group mean VAS scores to TTO scores has been proposed. We were able to replicate this finding of a power function. We found coefficients that were very similar to those from the literature, for 183 cancer patients. The relationship existed independently of disease state and health status.

Methods for determining the form of utilities are needed for the implementation of utility theory in specific decisions. An important step forward was achieved when utility theorists characterized useful parametric families of utilities, and simplifying decompositions of multiattribute utilities. The standard development of these results is based on expected utility theory which is now known to be descriptively invalid. The empirical violations of expected utility impair the credibility of utility assessments. This paper shows, however, that parametric and multiattribute utility results are robust against the major violations of expected utility. They retain their validity under non-expected utility theories that have been developed to account for actual choice behavior. To be precise, characterizations of parametric and multiattribute representations are extended to rank dependent utility, state dependent utility, Choquet expected utility, and prospect theory. Added after publication: Our Theorems 1 and 2 were essentially already given as Theorems 4 and 3, respectively, in Udo Ebert (1988), "Measurement of Inequality: An Attempt at Unification and Generalization," Social Choice and Welfare 5, 147-169. We discovered this only after publication.

We examined the feasibility and the proportional trade-off assumption of the Time Trade-Off method. Utilities were assessed of the actual health states of 54 testicular and 72 colorectal cancer patients, treated with the curative intent and 29 incurable colorectal cancer patients. Three periods of time were used to assess proportionality: the subject's life expectancy and two shorter periods. Results showed the method to be feasible in curatively treated patients, though the use of life expectancy posed difficulties in some very old subjects. This same difficulty was encountered in patients with symptomatic incurable disease. A two step procedure is proposed as a solution. The proportional trade-off assumption was violated. Utilities for the longer period were smaller than those for the shorter periods. Life expectancy and trade-off did not correlate, though. Remarkable was that many patients were unwilling to trade at all. The implications of the findings are discussed.

Publisher Summary This chapter examines the second cancer risk following testicular cancer. As a result of the introduction of cisplatin-based combination chemotherapy, survival from nonseminomatous tumors of the testis has greatly improved. The long-term effect of modern, platinum-based CT on SC risk has not been examined much, since the follow-up period for such studies was still rather short. Vinblastine and bleomycin have not been associated with the development of second malignancies. Cisplatin has been shown to have carcinogenic potential in experimental studies. Also, the cytostatic agent etoposide, which is frequently used in platinum-based CT, is a strong mutagen that has recently been shown to have leukaemogenic potential in humans. There has been some concern regarding the development of second malignancies after administration of platinum-based CT. In the statistical analysis, a comparison was made between SC incidence among the testicular cancer patients and cancer incidence in the general population. In this person-years type of analysis, the ratio of the observed and expected number of SCs in the study population was determined. Expected numbers of SC were computed with the use of age, sex, and calendar year-specific incidence rates.

In teaching hospitals all over the world, skills laboratories have been set up in order to train and assess minimally invasive surgical (MIS) skills. However, there are no generally accepted standards as to what an MIS skills laboratory should look like and how the training should be conducted. This study is an attempt to develop an international and consensus-based set of quality criteria for a skills laboratory for training MIS. Three quality domains for skills laboratory were defined: ‘personnel and resources’, ‘trainee motivation’ and ‘curriculum’. A list of consensus-based criteria, nine items per domain, was made. Twenty-three recognised experts in MIS rated each item on a 0 to 3 scale in the level of importance. The most important items per domain were: ‘personnel and resources’, the presence of a box trainer, a laparoscopic expert and the availability of financial resources; ‘trainee motivation’, mandatory training supervised by laparoscopic experts; and ‘curriculum’, the presence of a structured skills curriculum, dedicated time for training and a yearly evaluation of the skills of the resident. This consensus list can be used when setting up a skills laboratory, but also for verifying the quality of an existing laboratory. From there, the focus for new developments can be chosen.

The authors assessed the test-retest reliabilities of two treatment-preference instruments recently applied to the measurement of the utilities of health states after different treatment modalities for cancer. The first instrument measures the strengths of preferences concerning a choice between a wait-and-see policy, and treatment with radiotherapy after an initial surgical breast-conserving procedure for early breast cancer. The second measures the strengths of preferences concerning a choice between two hypothetical surgical treatment outcomes in cancer of the rectum with different probabilities of expected five-year survival. Both measure the strength of a subject's treatment preference given probabilities of treat ment-related costs and benefits. The subjects were radiotherapy technicians (n = 20) and cancer patients (n = 20) who were interviewed in weeks 2 and 4 of radiotherapy. The test- retest reliabilities of both instruments were inconsistent and moderately high, with Spear- man's rank correlations ranging from 0.38 to 0.81 and weighted kappas ranging from 0.38 to 0.69. To investigate whether the start of treatment with radiotherapy influenced the utilities that patients assigned to health states, the same procedure was applied in another, com parable, group of patients with cancer ( n = 20). For this group, the first assessment was made prior to the start of treatment and the second during the second week of radiation therapy. The scores of this group of patients indeed appeared to be less stable than the scores of the patients assessed in weeks 2 and 4 of radiotherapy. However, the instability of the scores could have been the result of test bias. Key words: test-retest reliability; utility assessment; oncology. (Med Decis Making 1993;13:133-140)

PURPOSE Improved survival in testicular cancer has been accompanied by concern about long-term side effects of therapy. We assessed the evolution of second cancer (SC) risk over a prolonged follow-up period, which has been rarely studied in large patient series. PATIENTS AND METHODS We estimated the risk of SCs in 1,909 patients with testicular cancer diagnosed in the Netherlands from 1971 to 1985. Complete medical information was obtained up to at least January 1988 for 92% of patients. Median follow-up was 7.7 years. For 89% of second tumors the diagnosis was confirmed through review of histologic slides; for an additional 8%, the diagnosis was verified by pathology reports only. RESULTS Seventy-eight patients developed a SC 1 year or more after start of treatment, as compared with 47.6 expected on the basis of incidence rates in the general population (relative risk [RR], 1.6; 95% confidence interval [CI], 1.3 to 2.1). The mean 15-year actuarial risk of all SCs was 9.8% (95% CI, 7.5% to 12.8%). Significantly increased RRs were observed for all gastrointestinal cancers combined (RR, 2.6; 95% CI, 1.7 to 3.9), stomach cancer (RR, 3.7; 95% CI, 1.8 to 6.8), contralateral testicular cancer (CLTC) (RR, 35.7; 95% CI, 21.8 to 55.2), and leukemia (RR, 5.1; 95% CI, 1.4 to 13.0). Patients who had received irradiation to the paraaortic lymph nodes and who survived testicular cancer for more than 5 years were at particularly high risk of developing stomach cancer (RR, 6.9; 95% CI, 3.3 to 12.7). The median interval between the diagnosis of testicular cancer and stomach cancer was 12.4 years. Patients treated with chemotherapy (CT) did not experience an increase in SCs in general. Indeed, CT-treated patients, as compared with those who received radiotherapy (RT), or surgery alone, had significantly reduced risk of CLTC. This finding might be attributed to an eradicating effect of CT on carcinoma in situ or subclinical CLTC. The excess risk of leukemia was not found to be clearly related to CT. CONCLUSION Testicular cancer patients who receive RT experience elevated risk of gastrointestinal tumors. CT does not seem to increase SC risk and may even decrease the risk of a CLTC. Following testicular cancer, the 15-year actuarial risk of all SCs is only about half the risk experienced by patients with Hodgkin's disease.

Aims To evaluate the validity and reliability in Dutch of the Pelvic Floor Inventories Leiden (PelFIs) for men and women, an administered questionnaire, developed to create a condition-specific pelvic floor questionnaire addressing all symptoms of micturition, defecation and sexual dysfunction related to pelvic floor dysfunction. Methods The PelFIs is an 83-item instrument for women and 76-item instrument for men measuring the degree of pelvic floor dysfunction, containing nine different domains. Questions have been selected which, from a clinical point of view, should configure a domain. The PelFIs was administered to healthy volunteers (N = 120), and to patients (N = 100). Reliability of the PelFIs was assessed by internal consistency and test-retest reliability. Construct validity was established comparing healthy volunteers and patients by intercorrelating the domains. Results A total of 220 questionnaires were completed; by 147 women and 73 men. Some domains in the men's questionnaire had a low alpha (α) although the overall α was good. The overall of the domains for men ranged from 0.53 to 0.90. The internal consistency for the total scale of men's questionnaire was 0.84. The overall of the domains in women ranged from 0.60 to 0.85. The internal consistency of the women's questionnaire was 0.88 for the total scale. Intraclass correlation ranged from 0.65 to 0.88. Differences between healthy volunteers and patients were statistically significant for all domains. Conclusion The PelFIs is a new, practical and conceptually clear questionnaire, which focus on micturition, defecation and/or sexual dysfunction related to pelvic floor dysfunction. Neurourol. Urodynam. 27:301–305, 2008. © 2007 Wiley-Liss, Inc.

The relationship between energy intake, selected nutrients and colorectal cancer was investigated in the population of Majorca, a Spanish island in the Mediterranean basin. A population-based case-control study using food frequency questionnaires was conducted during the period 1984-1988 and included 286 cases of colorectal cancer, 295 population controls and 203 hospital controls. Food composition tables and ad-hoc estimates of portion sizes were used to derive intake estimates of 29 nutrients and of total calories. Relative risks were calculated for quartiles of consumption of each specific nutrient after adjustment for total calorie intake. Colorectal cancer was found associated with dietary intake of total calories (RRs = 1.0, 1.6, 1.6, 2.6) and cholesterol (RRs = 1.0, 0.9, 1.7, 1.7) and a protective effect was associated with the intake of fibre from legumes (pulses) and folic acid. The associations and the trends were statistically significant. Among the main energy-supplying nutrients, after adjustment for calories from other sources, increased risks were found for protein (RRs = 1.0, 1.1, 1.7, 2.5), notably animal protein, and carbohydrates (RRs = 1.0, 1.5, 1.4, 2.2), whereas no effects were found for increased consumption of lipids or saturated fats.

The aim of this study was to develop and validate a semiquantitative food frequency questionnaire to classify individuals according to their intakes of retinol and beta-carotene. Food items for the questionnaire were selected both on the basis of their contribution to total population intake of retinol and beta-carotene and on the proportion of between-person variation explained, which was as calculated from data of two study populations in the Netherlands. Thus, 15 products containing retinol and 15 products containing beta-carotene were selected. These contributed over 90% to the total intake and explained 99% of the variation of retinol and beta-carotene, respectively. The questionnaire was validated against a dietary history in a population of 82 women (aged 30-49 years). The time elapsed between the two interviews was (on average) 25 days. Spearman rank-order correlation coefficients comparing the questionnaire with the dietary history were 0.54, 0.59, and 0.64 for retinol, beta-carotene, and total vitamin A, respectively. The proportion of exact agreement in the two extreme categories of vitamin A intake, based on quintiles, was 56%. The corresponding gross misclassification (from 1 extreme category into the opposite) was 3%. These data indicate that a very short questionnaire can classify subjects into categories according to their vitamin A intake.

Background It is unknown what minimal benefit in disease-free survival older patients with breast cancer require from adjuvant systemic therapy, and if this differs from that required by younger patients. We prospectively examined patients' preferences for adjuvant chemotherapy (aCT) and adjuvant hormonal therapy (aHT), factors related to minimally-required benefit, and patients' self-reported motivations. Patients and Methods Fifty-two younger (40-64 years) and 29 older (≥ 65 years) women with a first primary, invasive tumor were interviewed post-surgery, prior to receiving aCT/aHT recommendation. Results The proportions of younger versus older participants who would accept, refuse, or were undecided about therapy were 92% versus 62%, 4% versus 24%, and 4% versus 14% for aCT, and 92% versus 59%, 8% versus 17%, and 0% versus 24% for aHT. The proportion of older participants who would refuse rather than accept aCT was larger than that of younger participants ( P = .005). No significant difference was found for aHT ( P = .12). Younger and older participants' minimally-required benefit, in terms of additional 10-year disease-free survival, to accept aCT (median, 5% vs. 4%; P = .13) or aHT (median, 10% vs. 8%; P = .15) did not differ. Being single/divorced/widowed (odds ratio [OR], 0.16; P = .005), presence of geriatric condition (inability to perform daily activities, incontinence, severe sensory impairment, depression, polypharmacy, difficulties with walking; OR, 0.27; P = .047), and having a preference to make the treatment decision either alone or after considering the clinician's opinion (active role; OR, 0.15; P = .012) were independently related to requiring larger benefits from aCT. The most frequent motivations for/against therapy included the wish to survive/avoid recurrence, clinician's recommendation, side effects, and treatment duration (only aHT). Conclusion Whereas older participants were less willing to accept aCT than younger participants, no significant difference was found for aHT. However, a majority of older participants would still accept both therapies. Adjuvant systemic therapy should be discussed with eligible patients regardless of age.

Background Prospective data on chemotherapy for (frail) elderly patients with advanced colorectal cancer (aCRC) are scant. UFT/leucovorin might be as effective as and less toxic than capecitabine. We firstly randomized both agents in patients >65years with aCRC not amenable to receive combination chemotherapy. Patients and Methods Patients were randomised between first-line oral UFT/leucovorin and capecitabine in a Dutch multicentre trial. Primarily, efficacy and toxicity were determined. Secondary, quality of life (QoL) and abbreviated common geriatric assessment (aCGA) were analysed. Results Sixty-seven patients were randomised with a median age of 77years and 96% being frail. After interim analysis it was decided to stop recruitment because of low accrual. At a median follow up of 34months, the median progression-free survival (PFS) and overall survival (OS) were similar for both therapies, being 21weeks ( p =0.17) and 12months ( p =0.83), respectively. The overall response rates were 24% and 21%, respectively. Two patients died of possible treatment related complications in the UFT/leucovorin arm and 3 patients in the capecitabine arm. For UFT/leucovorin significantly less grade 3 or 4 hand/foot syndrome (0 vs 5) was observed. Overall, PFS was related to Charlson-comorbidity index ( p =0.049), LDH ( p =0.0011) and albumin ( p =0.009). OS was related to LDH ( p =0.0003), albumin ( p =0.0001), QoLC30/CR38 ( p =0.041), QoL visual analogue scale (VAS; p =0.016), and GFI ( p =0.028). Conclusion UFT/leucovorin and capecitabine had similar efficacy and different toxicity profiles in frail elderly patients with aCRC. Baseline serum levels of albumin and LDH, Charlson-comorbidity index, GFI and QoL were prognostic for clinical outcome.

Objective: To compare and contrast disease-specific quality of life instruments in Parkinson9s disease and assess their clinimetric properties. Methods: Two reviewers independently evaluated both thoroughness and results of studies regarding clinimetric characteristics of identified scales. Results: Twenty studies were found reporting on the clinimetric properties of four scales. The content validity of the Parkinson9s disease questionnaire-39 item version (PDQ-39), the Parkinson9s disease quality of life questionnaire (PDQL), and the “Fragebogen Parkinson LebensQualitat” (Parkinson Quality of Life questionnaire; PLQ) was adequate to good, but for the Parkinson9s impact scale (PIMS) it was insufficient. Construct validity of both the PDQ-39 and the PDQL was good, but for the PLQ and the PIMS this was insufficiently evaluated. Internal consistency of all scale totals and of subscale totals of the PDQL were good, whereas for the social support subscale of the PDQ-39 and four subscales of the PLQ this was inadequate. Test-retest reliability was not evaluated for the PDQL and was adequate in the other scales. Responsiveness was partially established for the PDQ-39, and not assessed for the other scales. The number of available translations, as well as the number of studies in which these instruments were used, differed considerably. Conclusions: The selection of an instrument partially depends on the goal of the study. In many situations however, the PDQ-39 will probably be the most appropriate HRQoL instrument. The PDQL may be considered as an alternative, whereas the PLQ may be considered in studies involving German speaking patients with Parkinson9s disease. Use of the PIMS should be considered only as a means of identifying areas of potential problems.

Objectives:The feasibility and convergent validity of a cost diary and a cost questionnaire was investigated.Methods:Data were obtained as part of a cost-utility analysis alongside a multicenter clinical trial in patients with resectable rectal cancer. A sample of 107 patients from 30 hospitals was asked to keep a weekly diary during the first 3 months after surgery, and a monthly diary from 3 to 12 months after surgery. A second sample of seventy-two patients from twenty-eight hospitals in the trial received a questionnaire at 3, 6, and 12 months after surgery, referring to the previous 3 or 6 months. Format and items of the questions were similar and included a wide range of medical and nonmedical items and costs after hospitalization for surgery.Results:Small differences were found with respect to nonresponse (range, 79 to 86 percent) and missing questions (range, 1 to 6 percent between the diary and questionnaire). For most estimates of volumes of care and of costs, the diary and questionnaire did not differ significantly. Total 3-month nonhospital costs were €1,860, €1,280, and €1,050 in the diary sample and €1,860, €1,090, and €840 in the questionnaire sample at 3, 6, and 12 months after surgery, respectively (p=.50). However, with respect to open questions, the diary sample tended to report significantly more care.Conclusions:For the assessment of health-care utilization in economic evaluations alongside clinical trials, a cost questionnaire with structured closed questions may replace a cost diary for recall periods up to 6 months.

OBJECTIVES: To select the best multi-criteria decision making method for use with cognitively impaired patients. Population. A convenience sample of 28 subjects, 12 healthy and 16 cognitively impaired. METHODS: Based on a literature review, 5 multicriteria methods were chosen for comparison including: Kepner-tregoe analysis (KTA), simple multi attribute rating technique (SMART), SMART using swing weights (SWING), Analytic Hierarchy Process (AHP) and Conjoint Analysis (CA). Four attributes of treatment were identified (impact, duration, and end-result of treatment and associated risks). Subjects were asked to both rank and rate the importance of these attributes. After using the methods to establish preferences for treatment, subjects were asked to judge the overall difficulty of the techniques on 1–10 score, and answer questions regarding clarity of explanation of method, difficulty in answering questions, understanding method in relation to goal, and use of the method in health care situations. Subjects were interviewed either once (n = 14) or twice (n = 14) (Only the results of the first measurement are presented) RESULTS: In the overall rating of methods CA scored best (mean score 3.65), followed by SMART (3.70), AHP (4.00), SWING (4.40) and KTA (4.67). CA also scored best on verbal/written explanation, understanding of method in relation to goal second and usefulness in health care situations, and scored second place on difficulty in answering questions. In the impaired population, AHP was rated best on the overall difficulty score. CONCLUSIONS: In this pilot study, conjoint analysis was the most preferred method of preference elicitation. Our main concern regarding CA is the time it takes to fill out a CA questionnaire and the fact that data analysis is most complicated of all methods included. Another concern regarding the use of multicriteria methods needing further study is the rate of rank-reversal between methods in the cognitively impaired population.

Use of mcdm methods in stroke population to obtain treatment preferences. No experience with cognitively impaired group. Existingliteraturereferstocognitiveburdenofmcdmmethodsandinfluenceof method on importance of attributes. Aim: Pilot test of 5 mcdm methods in stroke population.