Self-esteem in patients with venous thromboembolism predicts time trade-off values for own health.

BACKGROUND: The time trade-off (TTO) is a commonly used preference based method to assess health related values used in health economic analyses. Surprisingly little is known about the factors influencing the TTO. Since self-esteem is a predictor for health status measurements, and health status affects the TTO, we studied the relation between self-esteem and TTO values. METHODS: Data of 128 patients treated with vitamin K antagonists for venous thromboembolism on Short Form-36 (SF-36), Rosenberg self-esteem and patient characteristics were collected. TTO values were obtained for 'current health' and three chronic health states related to thrombosis, in face-to-face interviews with patients. Regression analyses were performed with the TTO as dependent variable. Analyses were performed in two groups; the complete sample, and traders only. Selected predictors were entered in four blocks: socio-demographic factors, medical-clinical factors, health status, and self-esteem. RESULTS: In the complete sample (N = 128), bivariate regression analysis showed that self-esteem explained 14% of the variance in TTO values for current health (p < .000, N = 117). In traders, multivariate regression analysis showed a significant relationship between self-esteem and TTO values for current health. Self-esteem increased the variance explained (R2) by 8.8%, from 28.1 to 36.9%, (p = 0.01; N = 57). For hypothetical health states, the effect of self-esteem was weaker and mostly absent after controlling for selected variables. CONCLUSIONS: In patients willing to trade-off time, higher self-esteem was associated with higher TTO values for own current health. Self-esteem explained an appreciable proportion of the variance in TTO values in traders. For hypothetical health states such associations were weak or absent.

A Head-On Ordinal Comparison of the Composite Time Trade-Off and the Better-Than-Dead Method.

OBJECTIVES: The valuation of health states worse than dead is challenging. Currently used time trade-off methods face problems in (1) detecting time-dependent preferences and (2) insensitivity toward severity for states worse than dead. The better-than-dead (BTD) method has the potential to detect time-dependent preferences. This study compares the BTD and composite time trade-off (cTTO) methods at the ordinal level. METHODS: An experiment was conducted in a convenience sample in which respondents (N = 200) valued the same set of 7 health states in the BTD method and cTTO method. Binary BTD responses were used, with response categories of better than dead and worse than dead. Ternary cTTO responses were used, with the additional equal-to-dead response category. Polychoric correlations were used to determine the agreement between these methods. Consistency and test-retest reliability were assessed within methods. RESULTS: Overall agreement between the cTTO and BTD method equaled 77.1% and differed between health states and respondents. For both methods, there were few inconsistencies, and the test-retest reliability was comparable (88%). Health states were more often considered worse than dead in the BTD method (BTD: 54.7%, cTTO: 37.2%). CONCLUSIONS: The high agreement between both methods and the comparable amount of inconsistencies and test-retest reliability suggest that the methods have similar measurement properties. The BTD method yielded higher frequencies of worse-than-dead responses while essentially asking respondents to make similar choices. This accounts for part of the disagreement between the methods. Several explanations are offered for this difference, yet more research is needed to explain this phenomenon.

Introducing Decision Aids into Routine Prostate Cancer Care in The Netherlands: Implementation and Patient Evaluations from the Multi-regional JIPPA Initiative.

Uptake of decision aids (DAs) in daily routine is low, resulting in limited knowledge about successful DA implementation at a large scale. We assessed implementation rates after multi-regional implementation of three different prostate cancer (PCa) treatment DAs and patient-perceived barriers and facilitators to use a DA. Thirty-three hospitals implemented one out of the three DAs in routine care. Implementation rates for each DA were calculated per hospital. After deciding about PCa treatment, patients (n = 1033) completed a survey on pre-formulated barriers and facilitators to use a DA. Overall DA implementation was 40%. For each DA alike, implementation within hospitals varied from incidental (< 10% of eligible patients receiving a DA) to high rates of implementation (> 80%). All three DAs were evaluated positively by patients, although concise and paper DAs yielded higher satisfaction scores compared with an elaborate online DA. Patients were most satisfied when they received the DA within a week after diagnosis. Pre-formulated barriers to DA usage were experienced by less than 10% of the patients, and most patients confirmed the facilitators. Many patients received a DA during treatment counseling, although a wide variation in uptake across hospitals was observed for each DA. Most patients were satisfied with the DA they received. Sustained implementation of DAs in clinical routine requires further encouragement and attention.

Shared decision-making for postoperative analgesia: A semistructured qualitative study.

BACKGROUND: Shared decision-making (SDM) and decision-support tools have attracted broad support in healthcare as they improve medical decision-making. Experts disagree on how these can help patients evaluate their present situation and possible outcomes of therapy, and how they might reduce decisional conflict. Little is known about their implementation, especially in anaesthesiology. OBJECTIVE: To obtain a more fundamental understanding of pre-operative SDM and evaluate the use of a decision-support tool for postoperative analgesia after major thoracic and abdominal surgery. DESIGN: A qualitative study with semistructured, in-depth interviews of patients and professionals. SETTING: Patient recruitment took place at the Radboud University Medical Centre in Nijmegen and the Canisius Wilhelmina Hospital in Nijmegen, a nonacademic teaching centre. Professionals of the Radboud University Medical Centre were invited to participate in the interviews. PARTICIPANTS: Interviews were performed with 10 individual patients and two focus groups both consisting of eight different professionals. MAIN OUTCOME MEASURES: To gain insight into the provision of pre-operative information, decision-making processes and the clarity and usability of a prototype decision-support tool. RESULTS: Professionals seemed to provide their patients with information directed towards the application of epidural analgesia, providing little attention to its negative effects. For many patients, the information was not tailored to their needs. Patients' involvement in decision-making was minimal, but they did not feel a need for more involvement. They were positive about the decision-support tool, although they indicated that it would not have influenced their treatment decision. Professionals expressed their doubt about the capacity of their patients to fully understand the decisions involved and about the clinical usability of the decision-support tool, because patients might misinterpret the information provided. CONCLUSION: The results of this study suggest that both patients and professionals did not adhere to some 'self-evident' principles of SDM when postoperative analgesia after major thoracic and abdominal surgery was discussed.

Quality-Adjusted Life-Years without Constant Proportionality.

BACKGROUND: A quality-adjusted life-year is a common unit of measurement in health valuation. Under its constant proportionality assumption, the value of a quality-adjusted life span is defined as the product of preference weight and life span. OBJECTIVES: To empirically identify an alternative functional relationship between life span and value by relaxing the constant proportionality assumption. METHODS: Using an online survey, 5367 respondents completed 30 to 40 paired comparisons where each involved a choice between two health outcomes: one with a longer life span and health problems (five-level EuroQol five-dimensional questionnaire) and the other with a shorter life span and no problems (time trade-off pair). Using 2670 pairs, a saturated model with indicator variables for 27 life spans and 90 health problems of varying duration and severity was estimated by maximum likelihood. Its coefficients empirically illustrate the relationship between life span and value on a quality-adjusted life-year scale. RESULTS: The results reject constant proportionality (P < 0.01) and support the use of a power function to describe the relationship between life span and value, namely, value = preference weight × life spanß. The estimate of power (ß = 0.415; 95% confidence interval 0.41-0.42) appears to depend on whether life span was expressed in a temporal unit of days (0.403), weeks (0.509), months (0.541), or years (0.654). CONCLUSIONS: Raising life span to a power less than 1 implies decreasing marginal value of life span and greatly improved model fit, and confirms previous violations of proportionality. This power function may replace conventional assumptions in health valuation studies. Nevertheless, governmental agencies may favor a longer time horizon than that of the general population.

Decision aids for second-line palliative chemotherapy: a randomised phase II multicentre trial.

BACKGROUND: There is increasing recognition of the delicate balance between the modest benefits of palliative chemotherapy and the burden of treatment. Decision aids (DAs) can potentially help patients with advanced cancer with these difficult treatment decisions, but providing detailed information could have an adverse impact on patients' well-being. The objective of this randomised phase II study was to evaluate the safety and efficacy of DAs for patients with advanced cancer considering second-line chemotherapy. METHODS: Patients with advanced breast or colorectal cancer considering second-line treatment were randomly assigned to usual care (control group) or usual care plus a DA (intervention group) in a 1:2 ratio. A nurse offered a DA with information on adverse events, tumour response and survival. Outcome measures included patient-reported well-being (primary outcome: anxiety) and quality of the decision-making process and the resulting choice. RESULTS: Of 128 patients randomised, 45 were assigned to the control group and 83 to the intervention group. Median age was 62 years (range 32-81), 63% were female, and 73% had colorectal cancer. The large majority of patients preferred treatment with chemotherapy (87%) and subsequently commenced treatment with chemotherapy (86%). No adverse impact on patients' well-being was found and nurses reported that consultations in which the DAs were offered went well. Being offered the DA was associated with stronger treatment preferences (3.0 vs. 2.5; p=0.030) and increased subjective knowledge (6.7 vs. 6.3; p=0.022). Objective knowledge, risk perception and perceived involvement were comparable between the groups. CONCLUSIONS: DAs containing detailed risk information on second-line palliative treatment could be delivered to patients with advanced cancer without having an adverse impact on patient well-being. Surprisingly, the DAs only marginally improved the quality of the decision-making process. The effectiveness of DAs for palliative treatment decisions needs further exploration. TRIAL REGISTRATION: Netherlands Trial Registry (NTR): NTR1113 (registered on 2 November 2007).

Does a decision aid for prostate cancer affect different aspects of decisional regret, assessed with new regret scales? A randomized, controlled trial.

OBJECTIVE: To develop and validate new regret scales and examine whether a decision aid affects different aspects of regret in the treatment choice for prostate cancer. METHODS: This was a multicentre trial (three sites) with imbalanced randomization (1 : 2). From 2008 to 2011, patients with localized prostate cancer were randomized 1 : 2 to usual care (N = 77) or usual care plus a decision aid presenting risks and benefits of different treatments (N = 163). The treatments were surgery and (external or interstitial) radiotherapy. Regret was assessed before, and 6 and 12 months after treatment, using the Decisional regret scale by Brehaut et al. (Medical Decision Making, 23, 2003, 281), and three new scales focusing on process, option and outcome regret. The relation between decision aid and regret was analysed by anova. RESULTS: The concurrent validity of the new regret scales was confirmed by correlations between regret and anxiety, depression, decision evaluation scales and health-related quality of life. With a decision aid, patient participation was increased (P = 0.002), but regret was not. If anything, in patients with serious morbidity the decision aid resulted in a trend to less option regret and less Brehaut regret (P = 0.075 and P = 0.061, with effect sizes of 0.35 and 0.38, respectively). Exploratory analyses suggest that high-risk patients benefitted most from the decision aid. CONCLUSION: The new regret scales may be of value in distinguishing separate aspects of regret. In general, regret was not affected by the decision aid. In patients with serious morbidity, a trend to lower option regret with a decision aid was observed.

Patients' Preferences for Information About the Benefits and Risks of Second-Line Palliative Chemotherapy and Their Oncologist's Awareness of These Preferences.

Communication about palliative treatment options requires a balance between providing patients with sufficient information and not providing unwanted information. Surveys have indicated that many patients with advanced cancer express a wish to receive detailed information. In this prospective multicenter study, the information desire of patients with advanced breast or colorectal cancer was further investigated by offering treatment-related information to patients using a decision aid (DA). In addition, this study explored oncologists' awareness of their patients' information desire. Seventy-seven patients with advanced breast or colorectal cancer facing the decision whether to start second-line palliative chemotherapy were offered a DA by a nurse. This DA contained information on adverse events, tumor response, and survival. The nurse asked the patient whether each information item was desired. Ninety-five percent of patients chose to receive information on adverse events, 91 % chose to receive information on tumor response, and 74 % chose to receive information on survival. Oncologists' judgment of patients' information desire was 100, 97, and 81 %, respectively. For all three information items together, oncologists correctly judged the information desire of 62 % of patients. This study confirms that many patients with advanced cancer wish to receive detailed information on the benefits and risks of palliative treatment options when the information is actually available. Oncologists were adequately aware of this high information desire, but had some difficulty judging the information desire of individual patients. A stepped approach to giving information ("preview, ask, tell, ask") may help to better meet patients' information needs.

Expected survival with and without second-line palliative chemotherapy: who wants to know?

BACKGROUND: According to surveys, many patients with advanced cancer wish to receive survival information. OBJECTIVE: This study investigated information preferences by offering patients a decision aid (DA) with information on expected survival for two treatment options: supportive care with or without second-line palliative chemotherapy. Predictors of accepting survival information were explored. DESIGN: Eligible patients in this multicentre prospective study were offered second-line chemotherapy for advanced breast or colorectal cancer. A nurse presented a DA on second-line treatment and asked patients whether they desired information on (i) adverse events, (ii) tumour response and (iii) survival. Data on 50 clinical and psychosocial patient characteristics were collected from inclusion forms and patient questionnaires. RESULTS: Seventy-seven patients received a DA; median age 62 years (range 32-80), 61% female, 77% colorectal cancer. Fifty-seven patients (74%; 95% CI 64-84) desired survival information. Four psychosocial characteristics (e.g. deliberative decision style) independently predicted information desire. However, the use of these characteristics to predict information desire hardly outperformed a simple prediction rule. CONCLUSIONS: Many patients desired information on expected survival when deciding about second-line treatment. However, our exploratory analysis indicated that patients desiring this information could not be identified based on their clinical or psychosocial characteristics. These findings can help encourage candid discussions about expected survival. Health professionals should be careful not to make implicit assumptions of information desire based on patient characteristics, but to explicitly ask patients if survival information is desired, and act accordingly.

Quality of life assessment in facial palsy: validation of the Dutch Facial Clinimetric Evaluation Scale.

This study aimed at validating an existing health-related quality of life questionnaire for patients with facial palsy for implementation in the Dutch language and culture. The Facial Clinimetric Evaluation Scale was translated into the Dutch language using a forward-backward translation method. A pilot test with the translated questionnaire was performed in 10 patients with facial palsy and 10 normal subjects. Finally, cross-cultural adaption was accomplished at our outpatient clinic for facial palsy. Analyses for internal consistency, test-retest reliability, construct validity and responsiveness were performed. Ninety-three patients completed the Dutch Facial Clinimetric Evaluation Scale, the Dutch Facial Disability Index, and the Dutch Short Form (36) Health Survey. Cronbach's α, representing internal consistency, was 0.800. Test-retest reliability was shown by an intraclass correlation coefficient of 0.737. Correlations with the House-Brackmann score, Sunnybrook score, Facial Disability Index physical function, and social/well-being function were -0.292, 0.570, 0.713, and 0.575, respectively. The SF-36 domains correlate best with the FaCE social function domain, with the strongest correlation between the both social function domains (r = 0.576). The FaCE score did statistically significantly increase in 35 patients receiving botulinum toxin type A (P = 0.042, Student t test). The domains 'facial comfort' and 'social function' improved statistically significantly as well (P = 0.022 and P = 0.046, respectively, Student t-test). The Dutch Facial Clinimetric Evaluation Scale shows good psychometric values and can be implemented in the management of Dutch-speaking patients with facial palsy in the Netherlands. Translation of the instrument into other languages may lead to widespread use, making evaluation and comparison possible among different providers.

Choice between prostatectomy and radiotherapy when men are eligible for both: a randomized controlled trial of usual care vs decision aid.

UNLABELLED: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Many patients are eligible for more than one treatment option for prostate cancer. In usual care, urologists have a large influence on the treatment choice. Decision aids, providing balanced information on the pros and cons of different treatment options, improve the match between patient preferences and treatment received. In men eligible for both surgery and external beam radiotherapy, treatment choice differed by hospital. Across the participating hospitals, the decision aid consistently led to fewer patients remaining undecided on their treatment preference and more patients choosing brachytherapy. OBJECTIVES: To examine the treatment choice for localized prostate cancer in selected men who were eligible for both prostatectomy and radiotherapy. To examine whether increased patient participation, using a decision aid, affected the treatment choice. PATIENTS AND METHODS: From 2008 to 2011, 240 patients with localized prostate cancer were enrolled from three separate hospitals. They were selected to be eligible for both prostatectomy and external beam radiotherapy. Brachytherapy was a third option for about half of the patients. In this randomized controlled trial, patients were randomized to a group which only discussed their treatment with their specialist (usual care group) and a group which received additional information from a decision aid presented by a researcher (decision aid group). The decision aid was based on a literature review. Predictors of treatment choice were examined. RESULTS: Treatment choice was affected by the decision aid (P = 0.03) and by the hospital of intake (P < 0.001). The decision aid led to more patients choosing brachytherapy (P = 0.02) and fewer patients remaining undecided (P < 0.05). Prostatectomy remained the most frequently preferred treatment. Age, tumour characteristics or pretreatment urinary, bowel or erectile functioning did not affect the choice in this selected group. Patients choosing brachytherapy assigned more weight to convenience of the procedure and to maintaining erectile function. CONCLUSIONS: Traditionally, patient characteristics differ between surgery and radiotherapy groups, but not in this selected group of patients. Men eligible for both prostatectomy and radiotherapy mostly preferred prostatectomy, and the treatment choice was influenced by the hospital they visited. Giving patients evidence-based information, by means of a decision aid, led to an increase in brachytherapy.

Efficacy and safety of palliative chemotherapy for patients with advanced breast cancer pretreated with anthracyclines and taxanes: a systematic review.

No standard monotherapy or combination palliative chemotherapy currently exists for patients with advanced breast cancer pretreated with anthracyclines and taxanes. In this systematic review we assess the current knowledge on the efficacy and safety of palliative single-agent chemotherapy drugs--capecitabine, vinorelbine, gemcitabine, and liposomal doxorubicin--commonly used in daily clinical practice. We identified 22 studies, of which ten investigated capecitabine, nine investigated vinorelbine, three investigated gemcitabine, and one investigated liposomal doxorubicin. The greatest amount of information was available for capecitabine and vinorelbine. These two drugs showed good efficacy. The disease control rate differed significantly between the four drugs, which is relevant in terms of how well tumour symptoms can be improved and whether quality of life can be maintained or even improved. To obtain more evidence of the efficacy and safety of chemotherapeutic agents used in this pretreated population of advanced breast cancer patients, randomised comparisons of the various drugs, as monotherapy and in combination with targeted agents, are needed.

In a Child's Shoes: Composite Time Trade-Off Valuations for EQ-5D-Y-3L with Different Proxy Perspectives.

BACKGROUND AND OBJECTIVES: EQ-5D-Y-3L health states are commonly valued by asking adults to complete stated preference tasks, 'given their views about a 10-year-old child' (hereafter referred to as proxy 1). The use of this perspective has been a source of debate. In this paper, we investigated an alternative proxy perspective: i.e. adults considered what they think a 10-year old-child would decide for itself (hereafter, proxy 2 (substitute)]. Our main objective was to explore how the outcomes, dispersion and response patterns of a composite time trade-off valuation differ between proxy 1 and proxy 2. METHODS: A team of four trained interviewers completed 402 composite time trade-off interviews following the EQ-5D-Y-3L protocol. Respondents were randomly allocated to value health states in either the proxy 1 or proxy 2 (substitute) perspective. Each respondent valued ten health states with the perspective they were assigned to, as well as one health state with the alternative perspective (33333). RESULTS: The use of different proxy perspectives yielded differences in EQ-5D-Y-3L valuation. For states in which children had considerable pain and were very worried, sad or unhappy, respondents' valuations were lower in proxy 1 than in proxy 2 (substitute) perspectives, by about 0.2. Within-subject variation across health states was lower for proxy 2 (substitute) than proxy 1 perspectives. Analyses of response patterns suggest that data for proxy 2 (substitute) perspectives were less clustered. CONCLUSIONS: There are systematic differences between composite time trade-off responses given by adults deciding for children and adults considering what children would want for themselves. In addition to warranting further qualitative exploration, such differences contribute to the ongoing normative discussion surrounding the source and perspective used for valuation of child and adolescent health.

Assessing the information desire of patients with advanced cancer by providing information with a decision aid, which is evaluated in a randomized trial: a study protocol.

BACKGROUND: There is a continuing debate on the desirability of informing patients with cancer and thereby involving them in treatment decisions. On the one hand, information uptake may be hampered, and additional stress could be inflicted by involving these patients. On the other hand, even patients with advanced cancer desire information on risks and prognosis. To settle the debate, a decision aid will be developed and presented to patients with advanced disease at the point of decision making. The aid is used to assess the amount of information desired. Factors related to information desire are explored, as well as the ability of the medical oncologist to judge the patient's information desire. The effects of the information on patient well-being are assessed by comparing the decision aid group with a usual care group. METHODS/DESIGN: This study is a randomized controlled trial of patients with advanced colorectal, breast, or ovarian cancer who have started treatment with first-line palliative chemotherapy. The trial will consist of 100 patients in the decision aid group and 70 patients in the usual care group. To collect complete data of 170 patients, 246 patients will be approached for the study. Patients will complete a baseline questionnaire on sociodemographic data, well-being measures, and psychological measures, believed to predict information desire. The medical oncologist will judge the patient's information desire. After disease progression is diagnosed, the medical oncologist offers the choice between second-line palliative chemotherapy plus best supportive care (BSC) and BSC alone. Randomization will take place to determine whether patients will receive usual care (n = 70) or usual care and the decision aid (n = 100). The aid offers information about the potential risks and benefits of both treatment options, in terms of adverse events, tumour response, and survival. Patients decide for each item whether they desire the information or not. Two follow-up questionnaires will evaluate the effect of the decision aid. DISCUSSION: This study attempts to settle the debate on the desirability of informing patients with cancer. In contrast to several earlier studies, we will actually deliver information on treatment options to patients at the point of decision making.

Evaluating the conduct and application of health utility studies: a review of critical appraisal tools and reporting checklists.

BACKGROUND: Published health utility studies are increasingly cited in cost-utility analyses to inform reimbursement decision-making. However, there is limited guidance for investigators looking to systematically evaluate the methodological quality of health utility studies or their applicability to decision contexts. OBJECTIVE: To describe how health utility concepts are reflected in tools intended for use with the health economic literature, particularly with respect to the evaluation of methodological quality and context applicability. METHODS: We reviewed the critical appraisal and reporting tools described in a 2012 report published by the Agency for Healthcare Research and Quality (AHRQ), supplemented with a keyword search of MEDLINE and EMBASE, to identify existing tools which include health utility constructs. From these tools, a list of relevant items was compiled and grouped into domain categories based on the methodological or applicability aspect they were directed toward. RESULTS: Of the 24 tools we identified, 12 contained items relevant to the evaluation of health utilities. Sixty-five items were considered relevant to the evaluation of quality, while 44 were relevant to the evaluation of applicability. Items were arranged into four domains: health state descriptions; selection and description of respondents; elicitation and measurement methods; and other considerations. CONCLUSION: As key inputs to cost-utility analyses, health utilities have the potential to significantly impact estimates of cost-effectiveness. Existing tools contain only general items related to the conduct or use of health utility studies. There is a need to develop tools that systematically evaluate the methodological quality and applicability of health utility studies.

Systematic review of benefits and risks of second-line irinotecan monotherapy for advanced colorectal cancer.

This study was performed to obtain a comprehensive overview of the benefits and risks of second-line irinotecan monotherapy for advanced colorectal cancer. The literature was systematically reviewed to identify phase II and phase III trials that investigated the effect of second-line monotherapy with irinotecan. Thirty studies were included in this review: 25 phase II studies including 32 samples and five phase III studies including six samples. A disease control rate of greater than or equal to 50% was found in 23 out of 32 phase II samples, and one out of two phase III samples that reported disease control rate. Median time to progression was 2.7-6.0 months in phase II samples and 3.0-4.3 months in phase III samples. Median overall survival ranged from 6.6 to 16.1 months in phase II samples and 9.1-10.8 months in phase III samples. The most important severe adverse event in both phase II and phase III trials was diarrhea (5-39 and 15-36%, respectively), followed by nausea (1-24 and 5-14%), vomiting (2-22 and 6-14%), and asthenia (0-31 and 4-21%). Treatment-related mortality was 0-2% in phase II samples and 0-5% in phase III samples. Quality-of-life scores in phase II studies were associated with tumor response. In phase III studies, the quality of life while on treatment with irinotecan was similar to that of 5-fluorouracil, but better than supportive care alone. The quality of life on the weekly schedule was similar to the 3-weekly schedule. This study provides a comprehensive overview of the benefits and risks of second-line irinotecan. In general, second-line treatment with irinotecan is beneficial to patients.

The relationship between change in subjective outcome and change in disease: a potential paradox.

BACKGROUND: Response shift theory suggests that improvements in health lead patients to change their internal standards and re-assess former health states as worse than initially rated when using retrospective ratings via the then-test. The predictions of response shift theory can be illustrated using prospect theory, whereby a change in current health causes a change in reference frame. Therefore, if health deteriorates, the former health state will receive a better rating, whereas if it improves, the former health state will receive a worse rating. OBJECTIVE: To explore the predictions of response shift and prospect theory by relating subjective change to objective change. METHODS: Baseline and 3-month follow-up data from a cohort of rheumatoid arthritis patients (N = 197) starting on TNFalpha-blocking agents were used. Objective disease change was classified according to a disease-specific clinical outcome measure (DAS28). Visual analogue scales (VAS) for general health (GH) and pain were used as self-reported measures. Three months after starting on anti-TNFalpha, patients used the then-test to re-rate their baseline health with regard to general health and pain. Differences between then-test value and baseline values were calculated and tested between improved, non-improved and deteriorated patients by the Student t-test. RESULTS: At 3 months, 51 (25.9%) patients had good improvement in health, 83 (42.1%) had moderate improvement, and 63 (32.0%) had no improvement or deteriorated in health. All patients no matter whether they improved, did not improve, or even became worse rated their health as worse retrospectively. The difference between the then-test rating and the baseline value was similarly sized in all groups. CONCLUSION: More positive ratings of retrospective health are independent of disease change. This suggests that patients do not necessarily change their standards in line with their disease change, and therefore it is inappropriate to use the then-test to correct for such a change. If a then-test is used to correct for shifts in internal standards, it might lead to the paradoxical result that patients who do not improve or even deteriorate increase significantly on self-reported health and pain. An alternative explanation for differences in retrospective and prospective ratings of health is the implicit theory of change which is more successful in explaining our results than prospect theory.

Concise evaluation of decision aids.

OBJECTIVE: Decision aids purport to help patients make treatment related choices. Several instruments exist to evaluate decision aids. Our aim is to compare the responsiveness of several instruments. METHODS: Two different decision aids were randomized in patients at high risk for breast and ovarian cancer. Treatment choices were between prophylactic surgery and screening. Effect sizes were calculated to compare the responsiveness of the measures. RESULTS: One decision aid was randomized in 390 women, the other in 91 ensuing mutation carriers. Three factors were identified related to Information, Well-being and Decision Making. Within each factor, single item measures were as responsive as multi-item measures. CONCLUSION: Four single items, 'the amount of information received for decision making,' 'strength of preference,' 'I weighed the pros and cons,' and 'General Health,' were adequately responsive to the decision aids. PRACTICE IMPLICATIONS: These items might be considered for inclusion in questionnaires to evaluate decision aids.

Cultural Values: Can They Explain Differences in Health Utilities between Countries?

Introduction. Health utilities are widely used in health care. The distributions of utilities differ between countries; some countries more often report worse than dead health states, while mild states are valued more or less the same. We hypothesize that cultural values explain these country-related utility differences. Research Question. What is the effect of sociodemographic background, methodological factors, and cultural values on differences in health utilities? Methods and Analyses. Time tradeoff data from 28 EQ-5D valuation studies were analyzed, together with their sociodemographic variables. The dependent variable was Δu, the utility difference between mild and severe states. Country-specific cultural variables were taken from the World Values Survey. Multilevel models were used to analyze the effect of sociodemographic background, methodology (3L v. 5L), and cultural values on Δu. Intraclass correlation (ICC) for country variation was used to assess the impact of the predicting variables on the variation between countries. Results. Substantial variation in Δu was found between countries. Adding cultural values did not reduce ICCs for country variation. Sociodemographic background variables were only weakly associated with Δu and did not affect the ICC. Δu was 0.118 smaller for EQ-5D-5L studies. Discussion.Δu varies between countries. These differences were not explained by national cultural values. In conclusion, despite correction for various variables, utility differences between countries remain substantial and unexplained. This justifies the use of country-specific value sets for instruments such as the EQ-5D.

Patient and general population values for luminal and perianal fistulising Crohn's disease health states.

BACKGROUND: In patients with Crohn's disease (CD), luminal disease activity paralleled by perianal fistulas may seriously impair health-related quality of life (HRQoL). Health utility values are not available from patients with CD that reflect the health loss associated with both luminal and perianal CD. OBJECTIVE: To generate utilities for luminal and concomitant perianal fistulising CD health states directly from patients and from members of the general public. METHODS: A cross-sectional survey was undertaken enrolling CD patients and a convenience sample of members of the general population. Respondents were asked to evaluate four common CD heath states [severe luminal disease (sCD), mild luminal disease (mCD), severe luminal disease with active perianal fistulas (sPFCD), and mild luminal disease with active perianal fistulas (mPFCD)] by 10-year time trade-off (TTO). In addition, patients assessed their current HRQoL by the TTO method. RESULTS: Responses of 206 patients (40.8% with perianal fistulas) and 221 members of the general population were analysed. Mean ± SD utilities among patients for sPFCD, sCD, mPFCD and mCD states were 0.69 ± 0.33, 0.73 ± 0.31, 0.80 ± 0.29 and 0.87 ± 0.26. Corresponding values in the general public were: 0.59 ± 0.31, 0.65 ± 0.29, 0.80 ± 0.26 and 0.88 ± 0.25. Patients with active perianal fistulas, previous non-resection surgeries, and higher pain intensity scores valued their current health as worse (p < 0.05). CONCLUSIONS: TTO is a feasible method to assess HRQoL in patients with perianal fistulising disease, often not captured by health status questionnaires. Utilities from this study are intended to support the optimization of treatment-related decision making in patients with luminal disease paralleled by active perianal fistulas.